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Descriptive Review of the Literature on Breast Cancer Outcomes: 1990 Through 2000

Descriptive Review of the Literature on Breast Cancer Outcomes: 1990 Through 2000 Abstract Background: There is increasing interest in the incorporation of nonbiomedical outcomes into cancer research. Objective: Our goal was to review the use of nonbiomedical outcomes in research on breast cancer care. Data sources: We conducted a MEDLINE search of all studies on breast cancer quality of life, preferences, satisfaction, and economics that were published during the period from January 1, 1990, through December 31, 2000. We also searched bibliographies of published articles. Study selection: We included original primary research and excluded reviews, methods papers, studies conducted outside the United States and Western Europe, or studies with fewer than 100 subjects. Data abstraction: Data were abstracted by using a structured tool. Data synthesis: There were 1089 articles identified; 230 were included. The greatest proportion of research focused on survivorship followed by screening. The most frequently reported outcomes were health-related quality of life (54%) followed by economic analyses (38%) and patient satisfaction (14%); only 9% measured patient preferences. Few studies included more than 10% nonwhite populations or focused on the elderly. No single instrument was used in more than 10% of the studies, and many authors developed de novo tools for use in their study. Methodologic flaws were prevalent and included use of nonstandard economic methods, insufficient power, low or differential response rates, and lack of control for baseline status. Conclusion: At present, outcomes measurement is variable in its approach and application to breast cancer care. More research is needed to develop practical approaches that are reliable, valid, and feasible in routine practice, that are applicable to diverse populations, and that can inform interventions to improve the quality of care across the full spectrum of services. The most general health outcome measure is survival. For breast and other cancers, 5-year survival or the interval of disease-free survival has customarily been used to evaluate the success of treatment. Clinical events, such as severity of illness, tumor response, or stage shifts, have served as intermediate measures of outcome, principally because they are believed to be associated with differences in survival. For many diseases, such as advanced breast cancer, curative treatment is not always possible. Still, the outcomes of noncurative care may be very different. For instance, therapeutic strategies may be associated with similar survival but different toxic effects; alternatively, one therapy may yield better survival but more severe side effects, while another may offer poorer survival but better quality of life (QOL) during the patient's remaining months or years. Thus, decisions about alternative therapies are often based on QOL considerations, in addition to the likelihood of survival (1,2). Even when cures are possible, the costs of treatment may exceed an individual's or society's willingness to pay. Although QOL has been an implied medical outcome since the time of Hippocrates (3,4), the landmark paper by Karnofsky et al. (5) marked the first explicit effort of physicians to systematically assess the impact of cancer treatments on the patient's QOL and not quantity of life. The next major tools developed to assess the impact of cancer and breast cancer therapy on QOL were not developed until the early 1980s. In the prototype, the Spitzer Quality of Life Index, QOL continued to be physician rated (6). Thus, physician assessment of symptoms, toxic effects, and/or QOL remained the standard in breast cancer outcomes research for almost four decades. Increasing consumerism and patient participation in health care decisions, occurring in parallel with the growth in interest in outcomes of care in the late 1970s and the 1980s, set the stage for the development of patient-based measures of general and breast cancer-related QOL (4,7). For example, in 1979, Ware et al. (8) presented results validating a patient's self-reported measure of general health status from the Rand Health Insurance Experiment. Preliminary incorporation of such measures into cancer cooperative group randomized controlled trials (RCTs) occurred in the late 1980s (4,9). Despite the recent explosion of QOL measures, particularly for breast cancer, routine incorporation of QOL outcomes into cancer research has been slow, and when used, outcomes have often been poorly measured. For instance, in a review of QOL measurement across a variety of medical conditions, Gill and Feinstein (10) found that 159 different measures of QOL were used in 75 studies, but fewer than half defined the target domains, only 17% included a patient-rated QOL, and just 9% elicited patients' preferences for health outcomes. Thus, there is a clear need for expanded research on practice-based outcomes measures. For such measures to be clinically relevant and feasible to collect, it is key that the research and clinical communities work together to take an active leadership role in this process. To set the stage for such activities, we review the current use of health outcomes across the spectrum of breast cancer care—from primary prevention and early detection through survivorship or death—that could be used as the basis of a research agenda for measuring the outcomes of breast cancer care. This review is intended to serve as a focal point for discussion and extension of existing efforts to improve the outcomes of breast cancer services. Methods We conducted a qualitative review of the literature on breast cancer health outcomes across all phases of breast cancer care, including primary prevention, early detection, diagnosis, local treatment, adjuvant treatment, treatment of metastatic disease, survivorship, and the dying experience (11). Conceptualization and Definition of Health Outcomes Outcomes research is the study of the net effects of the health care process on the health and well-being of individuals and populations. As such, it can encompass a wide breadth of issues, including research on satisfaction with care, effectiveness, costs of care, and measurement of patient preferences and QOL. The current construct of QOL draws on earlier use of social indicators, such as housing and employment status, to measure the well-being of populations (12-14). Breslow (15) expanded the measurement of population well-being to include the World Health Organization definition of health as “not only the absence of disease or of disability, but an overall state of physical, mental, and social well-being.” de Haes (16) later defined QOL as “the subjective evaluation of life as a whole,” and Cella and Cherin (17) expanded this definition to include patients' satisfaction with their level of functioning compared with an ideal level. Both of these latter definitions reflect the importance of the individual's subjective experience; the second definition highlights the role of personal values, or preferences, for health outcomes (3). The current consensus among outcomes researchers is that QOL is a multidimensional concept (3,18-23). The term “health-related QOL” (HRQOL) is used to refer to overall QOL in a health context (24). Although there is variation in the number and types of HRQOL domains suggested by different researchers, there is substantial overlap. Most researchers would agree that the following domains should be considered when deciding on HRQOL measures: 1) somatic concerns, such as pain and symptoms; 2) functional ability; 3) family well-being; 4) emotional well-being; 5) spirituality; 6) treatment satisfaction, including financial impact of illness; 7) future orientation; 8) sexuality, intimacy, and body image; 9) social functioning; 10) occupational functioning; and 11) preferences (3,22,25-28). The precise number and types of domains should be sufficiently broad to capture the impact of the illness or treatment on the patient but not to impose an undue burden on the patient or researcher; if the impact is largely unknown, the largest number of dimensions should be included while maintaining parsimony. Any one domain may be an outcome in and of itself. A 1991 National Cancer Institute-sponsored workshop on the measurement of QOL in cancer clinical trials (22) recommended that assessment be multidimensional, include general and cancer-specific tools, be patient self-reported, be measured at more than one point in time, and be evaluated after controlling for relevant medical and sociodemographic characteristics. These considerations guided our data abstraction. For the purposes of this review, health outcomes were defined as HRQOL or any of its domains, preferences for outcomes, satisfaction with health care or treatment decisions, and economic outcomes, such as costs of care, cost-effectiveness analysis (CEA), decision analysis, and cost-benefit analysis. Data Sources Multiple sources were used to identify all potential research for inclusion in the analysis. A MEDLINE search was conducted for all English language articles published during the period from January 1, 1990, through December 31, 2000. The earlier date of 1990 was selected to include research that was representative of current health outcomes and QOL research methods. The following key words were used for the search: Breast Neoplasms and Quality of Life, Health Status, Economics, Health Services Research, Delivery of Health Care, or Quality of Health Care. To limit our search more narrowly to QOL, satisfaction with health care or treatment decisions, or economic outcomes, our search of Quality of Health Care and Delivery of Health Care was restricted to articles listing these key words as a major MeSH term. For the other key words, we selected articles using these terms as major or minor MeSH headings. Because this search did not identify any articles on outcomes associated with the dying experience of breast cancer patients (other than survival), we conducted a supplemental search on this topic using the following terms: Palliative Care or Death and Dying and Breast Neoplasms or Cancer. Study Selection The “Methods” and “Results” sections were reviewed for eligibility by two investigators using a standardized abstraction form (29). Study inclusion criteria consisted of being conducted in the United States and Western Europe, being published in a peer-reviewed journal, and presenting data on a health outcome. We excluded 859 articles, including phase I or II randomized trials (n = 7), studies with fewer than 100 subjects (n = 67) (since there would be insufficient power for the majority of measures), reviews (n = 180), comments/letters (n = 140), reports focusing on outcomes methodology (n = 68), studies conducted outside the United States or Western Europe (n = 45) (for comparability of health care systems, attitudes, and culture), studies that did not include breast cancer (n = 7), and studies that did not include a QOL outcome (n = 345). If outcomes data, or data subsets, had been published in more than one journal or time period, the largest dataset that contained the highest quality of information was selected for abstraction, although all of the measures were noted. The full listing of articles retrieved by the search is available from the authors. Data Abstraction For studies eligible for inclusion, the following data were abstracted: the phase of care, study design, population characteristics (e.g., age and race), country, number of subjects, outcomes included, tools or methods used to measure these outcomes, language of measurement, assessment of comorbid conditions, mode of administration of measures, and whether the authors reported any reliability testing for instrument performance in their study population or a statement about the power to detect clinically meaningful differences in outcomes between groups. Data Analysis Data were summarized by use of descriptive statistics, Student's t tests for differences in means, analysis of variance for differences in groups, and chi-square tests for differences in proportions and trends over time. Results There were 1089 original research articles identified by the search; 230 (21%) of these met the criteria for study inclusion (seeAppendix Table 1) (30-264). These 230 articles reported on 155 distinct study samples. In the study period, there was a general increase in the number of articles that included breast cancer outcomes (Fig. 1; Table 1). This increase was largely due to increases in studies of QOL in the treatment and survivorship phases of care and economic studies of screening. Appendix Table 1. Characteristics of studies on the outcomes of primary prevention: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *BCPT = Breast Cancer Prevention Trial; CEA = cost-effectiveness analysis; LYS = life years saved; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; SEER = Surveillance, Epidemiology, and End Results [Program].   † See Table 3 for definitions of abbreviations of measures.   Lerman et al., 1995 (30)  Primary prevention   Cross-section   Female first-degree relatives of breast cancer patients aged 30-75 y; 96% white; United States   105   Anxiety, depression, impaired QOL   MHI; IES   Phone interview   Yes   N/A   Ganz et al., 1995 (96)  Primary prevention   RCT   Women enrolled in the BCPT comparing tamoxifen and placebo; >35 y old and at high risk for breast cancer or ≥60 y old; United States   9749   QOL   CES-D; MOS SF-36; BCPT Symptom Checklist; MOS sexual function   Self-administered   No   Yes   Stefanek et al., 1995 (32)  Primary prevention   Cross-section   Women with family history (≥1 first-degree relative) of breast cancer; 6-30 mo after surgery; United States   164   Satisfaction; depression, cancer-related worry   De novo tools; CES-D   Mail survey   No   Unknown   Nease and Ross, 1995 (33)  Primary prevention   Decision analysis   Women eligible for the BCPT; United States   N/A   Life expectancy   Survival   N/A   N/A   N/A   Schrag et al., 1997 (34)  Primary prevention   Decision analysis   Women at high-risk of BRCA 1/2 mutations; United States   N/A   LYS   Survival   N/A   N/A   N/A   Borgen et al., 1998 (35)  Primary prevention   Cross-section   Women 15 y (range, 1-50 y) after bilateral prophylactic mastectomy; mean age of 46 y at surgery (range, 25-73 y); 96% white; United States   370   Regrets about decision; satisfaction   De novo tool   Mail survey   No   N/A   Grann et al., 1999 (36) and 1998 (37)  Primary prevention   CEA   Ashkenazi Jewish women; United States   N/A   Utility; costs per LYS; QALYs   Medicare costs; survival; TTO (n = 54)   N/A   N/A   N/A   Grann et al., 1999 (38)  Primary prevention   Cross-section   Women aged 20-50 y with breast cancer, a personal history of multiple breast biopsies, or family history of breast cancer; United States   184   Preferences/utility; QOL   TTO; visual analog scale   N/A   N/A   N/A   Noe et al., 1999 (39)  Primary prevention   CEA   Women considered to be at high risk; received tamoxifen; enrolled in the National Surgical Adjuvant Breast and Bowel Project P-1 BCPT; United States   N/A   Utility; costs per life-year gained   Data on the benefits and risks of tamoxifen as observed in the BCPT   N/A   N/A   N/A   Brain et al., 2000 (40)  Primary prevention   RCT   Trial of Genetic Assessment in Breast Cancer (TRACE); Wales   735; subset of 545 at time of follow-up   QOL; costs   BCW; Satisfaction With Genetic Counseling Questionnaire; STAI; de novo tools   Self-administered   Yes   Unknown   Frost et al., 2000 (41)  Primary prevention   Cross-section   Women with family history who elected to undergo bilateral prophylactic mastectomy (1960-1993); United States   609; 94% response rate   QOL; long-term satisfaction   De novo tool   Mail survey   Yes   Unknown   Grann et al., 2000 (42)  Primary prevention   CEA   Women who tested positive for BRCA1/2 mutations; chemo-prevention with tamoxifen, raloxifene, or oral contraceptives vs. prophylactic surgery; United States   N/A   Preferences/utility; costs; QALY   Cumulative incidence rates from published literature; survival figures from SEER data; TTO to calculate QALYs; cost estimates based on Centers for Medicare and Medicaid Services payments, the SEER-Centers for Medicare and Medicaid Services database, and the Pharmacy Fundamental Reference         Julian-Reynier et al., 2000 (43)  Primary prevention   Cross-section   Women receiving genetic testing; France   471; 84% response rate   Patient willingness to diffuse information; attitude toward preventive options   De novo tools   Self-administered   No   Unknown   Smith and Hillner 2000 (44)  Primary prevention   CEA   Women enrolled in the National Surgical Adjuvant Breast Program P-1 BCPT receiving tamoxifen vs. placebo; United States   N/A   LYS; costs; preferences/utility   Medical care costs were estimated from the Agency for Health Care Policy and Research website; other parameters estimated from published literature   N/A   N/A   N/A   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *BCPT = Breast Cancer Prevention Trial; CEA = cost-effectiveness analysis; LYS = life years saved; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; SEER = Surveillance, Epidemiology, and End Results [Program].   † See Table 3 for definitions of abbreviations of measures.   Lerman et al., 1995 (30)  Primary prevention   Cross-section   Female first-degree relatives of breast cancer patients aged 30-75 y; 96% white; United States   105   Anxiety, depression, impaired QOL   MHI; IES   Phone interview   Yes   N/A   Ganz et al., 1995 (96)  Primary prevention   RCT   Women enrolled in the BCPT comparing tamoxifen and placebo; >35 y old and at high risk for breast cancer or ≥60 y old; United States   9749   QOL   CES-D; MOS SF-36; BCPT Symptom Checklist; MOS sexual function   Self-administered   No   Yes   Stefanek et al., 1995 (32)  Primary prevention   Cross-section   Women with family history (≥1 first-degree relative) of breast cancer; 6-30 mo after surgery; United States   164   Satisfaction; depression, cancer-related worry   De novo tools; CES-D   Mail survey   No   Unknown   Nease and Ross, 1995 (33)  Primary prevention   Decision analysis   Women eligible for the BCPT; United States   N/A   Life expectancy   Survival   N/A   N/A   N/A   Schrag et al., 1997 (34)  Primary prevention   Decision analysis   Women at high-risk of BRCA 1/2 mutations; United States   N/A   LYS   Survival   N/A   N/A   N/A   Borgen et al., 1998 (35)  Primary prevention   Cross-section   Women 15 y (range, 1-50 y) after bilateral prophylactic mastectomy; mean age of 46 y at surgery (range, 25-73 y); 96% white; United States   370   Regrets about decision; satisfaction   De novo tool   Mail survey   No   N/A   Grann et al., 1999 (36) and 1998 (37)  Primary prevention   CEA   Ashkenazi Jewish women; United States   N/A   Utility; costs per LYS; QALYs   Medicare costs; survival; TTO (n = 54)   N/A   N/A   N/A   Grann et al., 1999 (38)  Primary prevention   Cross-section   Women aged 20-50 y with breast cancer, a personal history of multiple breast biopsies, or family history of breast cancer; United States   184   Preferences/utility; QOL   TTO; visual analog scale   N/A   N/A   N/A   Noe et al., 1999 (39)  Primary prevention   CEA   Women considered to be at high risk; received tamoxifen; enrolled in the National Surgical Adjuvant Breast and Bowel Project P-1 BCPT; United States   N/A   Utility; costs per life-year gained   Data on the benefits and risks of tamoxifen as observed in the BCPT   N/A   N/A   N/A   Brain et al., 2000 (40)  Primary prevention   RCT   Trial of Genetic Assessment in Breast Cancer (TRACE); Wales   735; subset of 545 at time of follow-up   QOL; costs   BCW; Satisfaction With Genetic Counseling Questionnaire; STAI; de novo tools   Self-administered   Yes   Unknown   Frost et al., 2000 (41)  Primary prevention   Cross-section   Women with family history who elected to undergo bilateral prophylactic mastectomy (1960-1993); United States   609; 94% response rate   QOL; long-term satisfaction   De novo tool   Mail survey   Yes   Unknown   Grann et al., 2000 (42)  Primary prevention   CEA   Women who tested positive for BRCA1/2 mutations; chemo-prevention with tamoxifen, raloxifene, or oral contraceptives vs. prophylactic surgery; United States   N/A   Preferences/utility; costs; QALY   Cumulative incidence rates from published literature; survival figures from SEER data; TTO to calculate QALYs; cost estimates based on Centers for Medicare and Medicaid Services payments, the SEER-Centers for Medicare and Medicaid Services database, and the Pharmacy Fundamental Reference         Julian-Reynier et al., 2000 (43)  Primary prevention   Cross-section   Women receiving genetic testing; France   471; 84% response rate   Patient willingness to diffuse information; attitude toward preventive options   De novo tools   Self-administered   No   Unknown   Smith and Hillner 2000 (44)  Primary prevention   CEA   Women enrolled in the National Surgical Adjuvant Breast Program P-1 BCPT receiving tamoxifen vs. placebo; United States   N/A   LYS; costs; preferences/utility   Medical care costs were estimated from the Agency for Health Care Policy and Research website; other parameters estimated from published literature   N/A   N/A   N/A   View Large Fig. 1. View largeDownload slide Time trends in numbers of breast cancer outcomes research articles: 1990 through 2000 (seeTable 1 for breakdown by phase of care). Fig. 1. View largeDownload slide Time trends in numbers of breast cancer outcomes research articles: 1990 through 2000 (seeTable 1 for breakdown by phase of care). Table 1. Number of included articles on breast cancer outcomes* published during 1990 through 2000; breakdown of articles by year and phase of cancer care*   1990   1991   1992   1993   1994   1995   1996   1997   1998   1999   2000   Total, n   *Chi-square for trend P<.001. Total adds to more than 230 articles because some studies assessed more than one phase of care.   Primary prevention   0   0   0   0   0   4   0   1   2   3   5   15   Screening   2   2   5   2   3   3   2   4   10   7   1   41   Diagnosis   1   1   1   2   0   0   2   2   2   6   2   19   Local treatment   1   1   2   1   0   2   2   7   6   10   4   36   Adjuvant treatment   0   4   5   5   1   1   7   1   5   11   5   45   Treatment of metastatic disease   0   2   2   1   1   4   5   1   3   12   8   39   Survivorship and surveillance   1   0   1   2   4   7   5   5   16   7   3   51        Total   5   10   16   13   9   21   23   21   44   56   28   246     1990   1991   1992   1993   1994   1995   1996   1997   1998   1999   2000   Total, n   *Chi-square for trend P<.001. Total adds to more than 230 articles because some studies assessed more than one phase of care.   Primary prevention   0   0   0   0   0   4   0   1   2   3   5   15   Screening   2   2   5   2   3   3   2   4   10   7   1   41   Diagnosis   1   1   1   2   0   0   2   2   2   6   2   19   Local treatment   1   1   2   1   0   2   2   7   6   10   4   36   Adjuvant treatment   0   4   5   5   1   1   7   1   5   11   5   45   Treatment of metastatic disease   0   2   2   1   1   4   5   1   3   12   8   39   Survivorship and surveillance   1   0   1   2   4   7   5   5   16   7   3   51        Total   5   10   16   13   9   21   23   21   44   56   28   246   View Large Among the 230 articles, the most common outcome reported was HRQOL (54.4%) followed by costs/economic outcomes (38.3%), whereas there were statistically significantly fewer satisfaction (13.9%) or preference (9%) outcomes reported (P<.001). The proportion of these different types of outcomes varied across phase of care, with studies of survivorship having the greatest proportion of outcomes focused on QOL (69.1%) and studies of screening (9.7%) and diagnostic care (0%) having the lowest proportion of QOL outcomes (P<.001). These latter two phases had the highest proportion of economic studies compared with the other phases of care (P<.001) (data not shown). These findings are likely to be due to the nature of screening and diagnosis where the QOL outcomes are short term and difficult to capture, whereas the economic impact of differing strategies on survival may be large. We did not identify any studies about the quality of the dying experience for breast cancer patients per se. Within the metastatic treatment phase, there were 10 studies about palliative care that met our inclusion criteria (52-61); most were cross-sectional in design. The studies measured “will to live” (55), pain and symptom control (52-54,56,60,61), satisfaction (58), psychologic distress (52,57), and insight into prognosis (56). One study measured outcomes of the patients' caregivers (59). Among the study sample, the most prevalent type of study was an economic study (n = 91); 65.9% of these were CEAs and 24.2% were descriptions of the costs of care (Table 2). Among the 139 noneconomic studies, slightly more than one half (55.4%) were controlled studies (RCTs, longitudinal cohorts, or case-control studies), whereas almost one half were uncontrolled cross-sectional analyses. In a comparison of study design by phase of care, there were twice as many RCTs among studies of local and metastatic disease phases of care than among studies of other phases, whereas an uncontrolled, cross-sectional design was employed twice as often in studies of the survivorship phase of care as in studies of other phases (P<.01). Table 2. Study design in outcomes research by phase of breast cancer care   Study design     Phase of care   RCT*  Cohort   Cross-sectional   Economic†   Case-control   Total‡   *Randomized controlled trial.   † Economic studies include cost-effectiveness analyses, costs of care, and decision analyses.   ‡ Totals add to more than 230 because some studies assessed more than one phase of care.   Primary prevention   2   0   6   7   0   15   Screening, diagnosis   1   2   7   50   0   60   Local treatment   36   3   15   25   2   81   Treatment of metastatic disease   24   3   1   11   0   39   Survivorship and surveillance   9   10   28   2   2   51        Total   72   18   57   95   4   246     Study design     Phase of care   RCT*  Cohort   Cross-sectional   Economic†   Case-control   Total‡   *Randomized controlled trial.   † Economic studies include cost-effectiveness analyses, costs of care, and decision analyses.   ‡ Totals add to more than 230 because some studies assessed more than one phase of care.   Primary prevention   2   0   6   7   0   15   Screening, diagnosis   1   2   7   50   0   60   Local treatment   36   3   15   25   2   81   Treatment of metastatic disease   24   3   1   11   0   39   Survivorship and surveillance   9   10   28   2   2   51        Total   72   18   57   95   4   246   View Large The overwhelming majority of studies focused on white populations speaking the dominant language; only 24 (62-85) included more than 10% minority patients, and only three (68,70,86) reported more than 30% minority subjects. Five studies (69,87-90) noted use of translation of outcomes assessments into another language or languages. Few studies [e.g., (76,91-93)] concentrated on elderly women (women aged ≥65 years). There was a wide variety of instruments used in the study sample (Table 3) (94-195). The most commonly used tool was the Medical Outcomes Study SF-36 (8), but no single instrument was used in more than 10% of the studies (Table 4). Among the 139 noneconomic studies, 54.0% (n = 75) used previously validated tools, 20.1% (n = 28) relied solely on nonvalidated measurements developed de novo for the study, 19.4% (n = 27) used a combination of validated and de novo instruments, and 2.1% (n = 2) did not state what measures were used (see Appendix Tables 1, 2, 3, 4, 5, 6, 7). There were 127 validated tools represented in the 75 studies that used one or more validated measures. The average number of instruments used per noneconomic study was 2.8 (range, 1-10). Studies about survivorship or local therapy had the highest average number of measures per study (3.7 and 2.9, respectively), and studies of screening, metastatic disease, and primary prevention used the lowest number of measures per study (1.7, 2, and 2.1, respectively). With the exception of the studies of chemotherapy-induced nausea and vomiting-prevention interventions, all QOL studies included more than one domain of QOL. Table 3. Measures used in studies of breast cancer outcomes: 1990 through 2000 ADL = Activities of Daily Living (108)   ADQ = Adherence Determinants Questionnaire (94)   Andrews and Withey Quality of Life = Social Indicators of Well-Being (95)   BCPT Symptom Checklist = Breast Cancer Prevention Trial Symptom Checklist (96)   BCQ = Breast Cancer Quality of Life (97)   BCW = Breast Cancer Worries Scale (98)   BDI = Beck Depression Inventory (99)   Bedford College Life Events and Difficulties Schedules (100)   Berkman's Social Network Index (101)   BES = Body Esteem Scale (102)   bFs = Befindlichkeits-Skala (103)   Blatt Menopausal Index (104)   BPI = Brief Pain Inventory (105)   Bradburn's Positive Affect Scale (106)   Canada Health and Activity Limitation Survey (107)   Cancer Problem Scale (109)   Caplan Role and Emotional Function (110)   CARES = Cancer Rehabilitation and Evaluation System (111)   CDIS = Cancer Diagnostic Interview Scale (113)   CES-D = Center for Epidemiologic Studies—Depression (114)   Chalder Fatigue Scale (115)   Complex Figure Test (116)   D2 test (117)   DAS = Dyadic Adjustment Scale (121)   de Groot's Symptom Transition Scale (118)   Digit span of WAIS = digit span of Weschler Adult Intelligence Scale (119)   Duke-UNC Functional Social Support Questionnaire (120)   Eating Patterns Questionnaire (122)   ECOG (i.e., Eastern Cooperative Oncology Group) Analgesics Requirement Scale (123)   ECOG Performance Status (123)   Emotional Support Scale (160)   EORTC-QLQ-BR23 = European Organization for Research and Treatment of Cancer QLQ-BR23 (124)   EORTC-QLQ-C30 = European Organization for Research and Treatment of Cancer QLQ-C30 (125)   FACT = Functional Assessment of Cancer Illness Therapy (126)   FACT SP = Spirituality Profile (126)   Fepsy Tests (127)   FLIC = Functional Living Index—Cancer (128)   FPQLI = Ferrans and Powers Quality of Life Index (129)   Gaston-Johansson Pain-O-Meter (130)   GHQ = General Health Questionnaire (131)   HADS = Hospital Anxiety and Depression Scale (132)   House Social Support (133)   HQ = Health Questionnaire (134)   HSCL = Hopkins Symptoms Checklist (135)   IADL = Instrumental Activities of Daily Living (136)   IARB = Inventory of Adult Role Behavior and Self-Care (137)   IES = Impact of Event Scale (138)   Illness Intrusiveness Scale (139)   IWB = Index of Well-Being (140)   KPS = Karnofsky Performance Status (141)   Ladder = Self-Anchoring Scale of Hadley Cantril (142)   Lasry and Margoliese (143)   Lerman Cancer Worry Scale (144)   LES = Life Experiences Survey (145)   LWMAT = Locke-Wallace Martial Adjustment Test (146)   Massachusetts Women's Health Study Questionnaire (147)   McGill = McGill Pain Questionnaire (148)   Medical Research Council Quality of Life (149)   MHI = Mental Health Inventory of the Medical Outcomes Study (150)   Mini-MAC = Mini Mental Adjustment to Cancer (154)   MOS SF-36 = Medical Outcomes Study—Short Form 36 (151)   MOS Social Support Scale = Medical Outcomes Study Social Support Scale (152)   MPSSQ = Michigan Perceived Social Support Questionnaire (153)   MSAS = Memorial Symptom Assessment Scale (155)   Negative Affect Scale (156)   NHP = Nottingham Health Profile (157)   OTTAT = Oncology Treatment Toxicity Assessment Tool (158)   PACIS = Personal Adjustment to Chronic Illness (161)   PAIS-SR = Psychosocial Adjustment to Illness Scale (167)   PCQ = Psychological Consequences Questionnaire (168)   PDI = Pain Disability Index (159)   Perceived Social Support Scale (160)   Piper Fatigue Scale (162)   Pittsburgh Sleep Quality Index (163)   POMS = Profile of Mood States (166)   Postoperative Pain Questionnaire (164)   Principles of Living Survey (165)   PSI = Psychiatric Symptom Index (169)   Psychiatric Evaluation Form (170)   QOL-BC = Quality of Life in Breast Cancer (172)   QOL-CS = Quality of Life Cancer Survivors Tool (171)   Qtwist = Quality-Adjusted Time Without Symptoms or Toxicity (173)   Rand Health Survey (94)   Rey Auditory Verbal Learning Test (174)   Rosenberg's Scale of Self-Esteen (175)   RSCL = Rotterdam Symptom Checklist (176)   Satisfaction With Genetic Counseling Questionnaire (177)   SCID = Structured Clinical Interview Disease (178)   SCIWPR = Self-Care Inventory Wellness Promotion Scale (179)   SCL-90-R = Symptom Checklist (112)   SDS = Symptom Distress Scale (180)   Sexual Functioning Inventory (181)   SIP = Sickness Impact Profile (224)   Social Health Index (183)   Social Support Questionnaire (184)   STAI = State-Trait Anxiety Inventory (185)   Stroop Test (186)   SWLS = Statisfaction With Life Scale (187)   SWOG QOL Questionnaire = Southwest Oncology Group Quality of Life Questionnaire (188)   Symptom Experience Report (189)   Trial Making (190)   TTO = Time-tradeoff (191)   Urban Life Stress Scale (192)   Wisconsin Brief Pain Inventory Questionnaire (193)   WSFQ = Watts Sexual Function Questionnaire (194)   WTP = Willingness to Pay (195)   ADL = Activities of Daily Living (108)   ADQ = Adherence Determinants Questionnaire (94)   Andrews and Withey Quality of Life = Social Indicators of Well-Being (95)   BCPT Symptom Checklist = Breast Cancer Prevention Trial Symptom Checklist (96)   BCQ = Breast Cancer Quality of Life (97)   BCW = Breast Cancer Worries Scale (98)   BDI = Beck Depression Inventory (99)   Bedford College Life Events and Difficulties Schedules (100)   Berkman's Social Network Index (101)   BES = Body Esteem Scale (102)   bFs = Befindlichkeits-Skala (103)   Blatt Menopausal Index (104)   BPI = Brief Pain Inventory (105)   Bradburn's Positive Affect Scale (106)   Canada Health and Activity Limitation Survey (107)   Cancer Problem Scale (109)   Caplan Role and Emotional Function (110)   CARES = Cancer Rehabilitation and Evaluation System (111)   CDIS = Cancer Diagnostic Interview Scale (113)   CES-D = Center for Epidemiologic Studies—Depression (114)   Chalder Fatigue Scale (115)   Complex Figure Test (116)   D2 test (117)   DAS = Dyadic Adjustment Scale (121)   de Groot's Symptom Transition Scale (118)   Digit span of WAIS = digit span of Weschler Adult Intelligence Scale (119)   Duke-UNC Functional Social Support Questionnaire (120)   Eating Patterns Questionnaire (122)   ECOG (i.e., Eastern Cooperative Oncology Group) Analgesics Requirement Scale (123)   ECOG Performance Status (123)   Emotional Support Scale (160)   EORTC-QLQ-BR23 = European Organization for Research and Treatment of Cancer QLQ-BR23 (124)   EORTC-QLQ-C30 = European Organization for Research and Treatment of Cancer QLQ-C30 (125)   FACT = Functional Assessment of Cancer Illness Therapy (126)   FACT SP = Spirituality Profile (126)   Fepsy Tests (127)   FLIC = Functional Living Index—Cancer (128)   FPQLI = Ferrans and Powers Quality of Life Index (129)   Gaston-Johansson Pain-O-Meter (130)   GHQ = General Health Questionnaire (131)   HADS = Hospital Anxiety and Depression Scale (132)   House Social Support (133)   HQ = Health Questionnaire (134)   HSCL = Hopkins Symptoms Checklist (135)   IADL = Instrumental Activities of Daily Living (136)   IARB = Inventory of Adult Role Behavior and Self-Care (137)   IES = Impact of Event Scale (138)   Illness Intrusiveness Scale (139)   IWB = Index of Well-Being (140)   KPS = Karnofsky Performance Status (141)   Ladder = Self-Anchoring Scale of Hadley Cantril (142)   Lasry and Margoliese (143)   Lerman Cancer Worry Scale (144)   LES = Life Experiences Survey (145)   LWMAT = Locke-Wallace Martial Adjustment Test (146)   Massachusetts Women's Health Study Questionnaire (147)   McGill = McGill Pain Questionnaire (148)   Medical Research Council Quality of Life (149)   MHI = Mental Health Inventory of the Medical Outcomes Study (150)   Mini-MAC = Mini Mental Adjustment to Cancer (154)   MOS SF-36 = Medical Outcomes Study—Short Form 36 (151)   MOS Social Support Scale = Medical Outcomes Study Social Support Scale (152)   MPSSQ = Michigan Perceived Social Support Questionnaire (153)   MSAS = Memorial Symptom Assessment Scale (155)   Negative Affect Scale (156)   NHP = Nottingham Health Profile (157)   OTTAT = Oncology Treatment Toxicity Assessment Tool (158)   PACIS = Personal Adjustment to Chronic Illness (161)   PAIS-SR = Psychosocial Adjustment to Illness Scale (167)   PCQ = Psychological Consequences Questionnaire (168)   PDI = Pain Disability Index (159)   Perceived Social Support Scale (160)   Piper Fatigue Scale (162)   Pittsburgh Sleep Quality Index (163)   POMS = Profile of Mood States (166)   Postoperative Pain Questionnaire (164)   Principles of Living Survey (165)   PSI = Psychiatric Symptom Index (169)   Psychiatric Evaluation Form (170)   QOL-BC = Quality of Life in Breast Cancer (172)   QOL-CS = Quality of Life Cancer Survivors Tool (171)   Qtwist = Quality-Adjusted Time Without Symptoms or Toxicity (173)   Rand Health Survey (94)   Rey Auditory Verbal Learning Test (174)   Rosenberg's Scale of Self-Esteen (175)   RSCL = Rotterdam Symptom Checklist (176)   Satisfaction With Genetic Counseling Questionnaire (177)   SCID = Structured Clinical Interview Disease (178)   SCIWPR = Self-Care Inventory Wellness Promotion Scale (179)   SCL-90-R = Symptom Checklist (112)   SDS = Symptom Distress Scale (180)   Sexual Functioning Inventory (181)   SIP = Sickness Impact Profile (224)   Social Health Index (183)   Social Support Questionnaire (184)   STAI = State-Trait Anxiety Inventory (185)   Stroop Test (186)   SWLS = Statisfaction With Life Scale (187)   SWOG QOL Questionnaire = Southwest Oncology Group Quality of Life Questionnaire (188)   Symptom Experience Report (189)   Trial Making (190)   TTO = Time-tradeoff (191)   Urban Life Stress Scale (192)   Wisconsin Brief Pain Inventory Questionnaire (193)   WSFQ = Watts Sexual Function Questionnaire (194)   WTP = Willingness to Pay (195)   View Large Table 4. Instruments most commonly used in breast cancer outcomes studies: 1990 through 2000 Instrument   No. of studies (%)   Author of instrument, reference No.   MOS SF-36 = Medical Outcomes Study—Shortform 36   20 (8.7)   (151)  EORTC-QLQ-C30 = European Organization for Research and Treatment of Cancer QLQ-C30   15 (6.5)   (125)  CARES = Cancer Rehabilitation and Evaluation System   11 (4.8)   (111)  FLIC = Functional Living Index—Cancer   10 (4.4)   (228)  CES-D = Center for Epidemiologic Studies—Depression   8 (3.5)   (114)  RSCL = Rotterdam Symptom Checklist   8 (3.5)   (176)  HADS = Hospital Anxiety and Depression Scale   7 (3.0)   (132)  Linear Rating Scale   6 (2.6)     POMS = Profile of Mood States   6 (2.6)   (166)  BCPT Symptom Checklist = Breast Cancer Prevention Trial Symptom Checklist   5 (2.2)   (31)  KPS = Karnofsky Performance Status   5 (2.2)   (226)  IES = Impact of Event Scale   4 (1.7)   (138)  LES = Life Experiences Survey   4 (1.7)   (145)  STAI = State-Trait Anxiety Inventory   4 (1.7)   (185)  TTO = Time-tradeoff   4 (1.7)   (191)  Instrument   No. of studies (%)   Author of instrument, reference No.   MOS SF-36 = Medical Outcomes Study—Shortform 36   20 (8.7)   (151)  EORTC-QLQ-C30 = European Organization for Research and Treatment of Cancer QLQ-C30   15 (6.5)   (125)  CARES = Cancer Rehabilitation and Evaluation System   11 (4.8)   (111)  FLIC = Functional Living Index—Cancer   10 (4.4)   (228)  CES-D = Center for Epidemiologic Studies—Depression   8 (3.5)   (114)  RSCL = Rotterdam Symptom Checklist   8 (3.5)   (176)  HADS = Hospital Anxiety and Depression Scale   7 (3.0)   (132)  Linear Rating Scale   6 (2.6)     POMS = Profile of Mood States   6 (2.6)   (166)  BCPT Symptom Checklist = Breast Cancer Prevention Trial Symptom Checklist   5 (2.2)   (31)  KPS = Karnofsky Performance Status   5 (2.2)   (226)  IES = Impact of Event Scale   4 (1.7)   (138)  LES = Life Experiences Survey   4 (1.7)   (145)  STAI = State-Trait Anxiety Inventory   4 (1.7)   (185)  TTO = Time-tradeoff   4 (1.7)   (191)  View Large Appendix Table 2. Characteristics of studies on the outcomes of screening: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *CBE = clinical breast exam; CEA = cost-effective analysis; FN = false negative; FP = false positive; HC = health care; LYS = life years saved; N/A = not available; PCQ = psychological consequences questionnaire; QALY = quality-adjusted life years; RCT = randomized controlled trial.   † SeeTable 3 for definitions of abbreviations of measures.   Haiart et al., 1990 (45)  Screening   Costs of care   Mobile mammography using single view for women 40-65 y old; Scotland   6080   Costs; feasibility   Direct costs in NHP; patient time, travel, and lost opportunity costs   N/A   N/A   N/A   Gram et al., 1990 (46)  Screening   Cross-section   Women with negative and false-positive mammograms 6 mo after screen; average age 47 y; Norway   278; 89% response rate   QOL   Ladder; WTP; TTO; de novo anxiety and depression items   Mail survey   No   Unknown   Smith et al., 1991 (47)  Screening   RCT   Women attending the Leicestershire Breast Screening Service for abnormal mammograms; United Kingdom   103; 87% response rate   Satisfaction   De novo tool   In-person interview; mail survey   No   Unknown   Zappa et al., 1995 (227)  Screening   Costs of care   Population screening of women aged 50-70 y; Italy   38 676   Costs per woman screened; cost per cancer detected   Costs of recruitment, screening, and follow-up from the NHP   N/A   N/A   N/A   de Haes et al., 1991 (228); de Koning et al., 1991 (229)  Screening   CEA   Women of different ages and intervals of screening; The Netherlands   N/A   Costs per LYS; costs per QALYs   Costs and charges; survival; utilities from expert opinion (n = 27) with the use of published literature   Not stated   N/A   N/A   Brown, 1992 (230)  Screening   CEA   Women ≥50 y old; test effects of increasing age; United States   N/A   Costs; LYS   Direct medical costs only; survival based on published literature   N/A   N/A   N/A   Zavertnik et al., 1992 (231)  Screening   Costs of care   Costs of delivering low-cost mammography; United States   9452   Costs per cancer detected   Fixed and variable costs of screening program; cases detected   N/A   N/A   N/A   Mandelblatt et al., 1992 (76)  Screening   Decision analysis/CEA   Women aged ≥65 y with comorbid illnesses; black and white; United States   N/A   Costs; LYS; QALYs   Direct medical costs only; survival based on published literature; utility estimated from expert opinion   Not stated   N/A   N/A   Vaile et al., 1993 (232)  Screening   Longitudinal cohort   Women aged 50-64 y invited for screening who attended and had a negative test; England   2060; 65% response rate; 12% lost to follow-up   Satisfaction   De novo tool   Mail survey   No   No   Roworth et al., 1993 (233)  Screening   Cross-section   Women aged 50-64 y attending screening; Scotland   3000; 86% response rate   Satisfaction with screening; pain and pressure experienced; intention to return   Cockburn Satisfaction With Screening Tool; de novo questions   Mail survey   No   Unknown   Richardson et al., 1994 (234)  Screening   Cross-section   Women aged 50-64 y attending screening in urban and rural areas; New Zealand (included since dealing with satisfaction with screening—very few studies)   474; 93% response rate   Satisfaction with screening; anxiety   De novo tool   Mail survey   No   Unknown   Nutting et al., 1994 (77)  Screening   CEA   Mammogram + CBE vs. CBE in community of 750 American Indian women aged ≥50 y; United States   N/A   Costs; deaths averted; 5-y survival   Indian health service costs; survival based on published literature   N/A   N/A   N/A   Beemsterboer et al., 1994 (235)  Screening   CEA   Women aged 50-69 y; Germany   N/A   Costs per LYS   Direct medical costs; survival with the use of local data   N/A   N/A   N/A   Boer et al., 1995 (236) and 1998 (237)  Screening   CEA   Determination of upper-age limit for screening; The Netherlands   N/A   Costs per QALYs   Direct medical care costs; survival; utilities with the use of published data; source for utilities not described   N/A   N/A   N/A   Brown et al., 1995 (240)  Screening   CEA of nonrandom trial   Screening using one-vs. two-view mammography among women aged 50-64 y; England   26 430   Costs per cancer detected   Costs of screen and diagnostic follow-up in NHS; patient time costs   N/A   N/A   N/A   Feig, 1995 (239)  Screening   CEA   Women aged 40-49 y; United States   N/A   Costs of screening and diagnosis per woman screened or per LYS   Charges and cost estimates based on published literature   N/A   N/A   N/A   Brown et al., 1996 (240)  Screening   CEA   Mammography among women aged 50-64 y; one vs. two readings with or without consensus on films; England   33 734   Costs per cancer detected   Direct medical and nonmedical care costs to NHS and women based on local data   N/A   N/A   N/A   Evans et al., 1996 (241)  Screening   CEA   Women aged 50-64 y; Spain   100 000   Costs per cancer detected   Costs based on local data   N/A   N/A   N/A   Mandelblatt et al., 1997 (78)  Screening   CEA   Women seeking care in an urban public hospital emergency room; United States   N/A   Costs per LYS   Direct medical care costs and hospital charges; survival based on local data and published literature   N/A   N/A   N/A   Salzmann et al., 1997 (242)  Screening   CEA   Women starting mammography at ages 40-49 y vs. 50-69 y; United States   N/A   Costs; LYS   Direct medical costs only; survival based on published literature   N/A   N/A   N/A   Torgerson and Gosden, 1997 (243)  Screening   CEA   Women aged 66-69 y vs. 51-65 y; England   N/A   Deaths averted; LYS   Age-specific effects; number of deaths and survival; assumes resources are equal in the 2 age groups   N/A   N/A   N/A   Warmerdam et al., 1997 (244)  Screening   CEA   Women aged 50-69 y; The Netherlands   N/A   Costs; LYS   Costs in the German HC system; survival based on published literature and local data   N/A   N/A   N/A   Bakker et al., 1998 (245)  Screening   Cross-section; description   Convenient sample of women ≥50 y old (mean age, 61 y; range, 50-85 y) interviewed after mammography; Canada   256; 81% response rate   Satisfaction; distress   PCQ; de novo items   Telephone interview   No   No   Boer et al., 1998 (237)  Screening   CEA   Women living in the northwest region of England   N/A   Preferences/utility; costs; life-years saved; number of deaths prevented   Screening and cost data from the NHS breast-screening program   N/A   N/A   N/A   Gilbert et al., 1998 (246)  Screening   Cohort; longitudinal   Women aged 50-64 y following a false-positive screening mammography; Scotland   124   Psychologic distress   HADS; health questionnaire   Self-administered; mail survey; in-person interview   No   Unknown   Johnston et al., 1998 (206)  Screening   Cross-section   Women aged 40-64 y screened within 6 mo of screen or invited to be screened; England   440   Preferences for temporary states (FP, FN, etc.)   TTO   In-person interview   Yes   Yes   Lamarque et al., 1998 (247)  Screening   CEA   Women aged 40-60 y; France   N/A   Costs per case detected   Direct and non-direct medical costs (travel and time); biopsyproven disease based on local data   N/A   N/A   N/A   Rosenquist and Lindfors, 1998 (248)  Screening   CEA   Women beginning screening at age 40 y at different intervals until age 79 y; United States   N/A   Incremental costs per LYS   Direct medical costs; survival based on published literature   N/A   N/A   N/A   Schweitzer et al., 1998 (79)  Screening   CEA   Low-income black and Hispanic women using a mobile mammography van; United States   N/A   Costs per cancer detected   Microcosting of actual van services; biopsy-proven cancer based on published literature   N/A   N/A   N/A   Boer et al., 1998, (237)  Screening   CEA   Women at 2-y vs. 3-y intervals; stop screening at age 64 y vs. age 69 y; England   N/A   Costs; LYS   NHS costs; survival based on published literature   N/A   N/A   N/A   Wolstenholme et al., 1998 (249)  Screening   CEA   Costs of screening, incorporating the downstream costs of treatment among a regional sample diagnosed in 1991; England   137   Costs; LYS   Costs in the NHS; observed survival based on published literature and local data   N/A   N/A   N/A   Allen et al., 1999 (250)  Screening   CEA   Sestamibi scintimammography for women >40 y old with dense breasts; United States   N/A   Preferences/utility; costs   Single time-point analysis   N/A   N/A   N/A   Boer et al., 1999 (51)  Screening   CEA   Women aged ≥65 y; The Netherlands   N/A   Preferences/ utility; costs; LYS; extra incidence; extra life-years with disease   Data from the Dutch screening projects   N/A   N/A   N/A   Gyrd-Hansen, 1999 (251)  Screening   CEA   Costs of screening for colorectal, cervical, and breast cancers from national health care sector perspective; Denmark   N/A   Preferences/utility; costs   Published data from Swedish and Dutch screening programs and trials   N/A   N/A   N/A   Leivo et al., 1999 (252)  Screening   CEA   Women aged 50-64 y screened in the Finnish nationwide screening program (1987-1992); Finland   90 000   Preferences/utility; costs; LYS   Published studies and national cancer statistics, health market sources   N/A   N/A   N/A   Norum, 1999 (253)  Screening   CEA   Women aged 50-64 y screened every 2 y in a demonstration program; Norway   46 329   Costs per cancer detected; costs per LYS   Costs in the screening project; survival with the use of local data; production gains or losses   N/A   N/A   N/A   Secker-Walker et al., 1999 (91)  Screening   Costs of care   Women attending screening in 2 geographic areas; majority 65-79 y old (range, <50-80+); United States   445; 49% response rate   Patient time and costs associated with screening and diagnosis   Time and travel time; out-of-pocket costs   Telephone interview   No   Unknown   van der Pol et al., 1999 (254)  Screening   CEA   Women in sparsely populated areas; island communities of Scotland   N/A   Preferences/utility; costs   Time and travel costs   N/A   N/A   No   Haas et al., 2000 (84)  Screening   Cross-section   Women who had abnormal mammograms or mammography for clinical breast concern; United States   751; 77% response rate   Quality of care   Cross-sectional patient survey and medical record review   Telephone interview   No   Unknown   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *CBE = clinical breast exam; CEA = cost-effective analysis; FN = false negative; FP = false positive; HC = health care; LYS = life years saved; N/A = not available; PCQ = psychological consequences questionnaire; QALY = quality-adjusted life years; RCT = randomized controlled trial.   † SeeTable 3 for definitions of abbreviations of measures.   Haiart et al., 1990 (45)  Screening   Costs of care   Mobile mammography using single view for women 40-65 y old; Scotland   6080   Costs; feasibility   Direct costs in NHP; patient time, travel, and lost opportunity costs   N/A   N/A   N/A   Gram et al., 1990 (46)  Screening   Cross-section   Women with negative and false-positive mammograms 6 mo after screen; average age 47 y; Norway   278; 89% response rate   QOL   Ladder; WTP; TTO; de novo anxiety and depression items   Mail survey   No   Unknown   Smith et al., 1991 (47)  Screening   RCT   Women attending the Leicestershire Breast Screening Service for abnormal mammograms; United Kingdom   103; 87% response rate   Satisfaction   De novo tool   In-person interview; mail survey   No   Unknown   Zappa et al., 1995 (227)  Screening   Costs of care   Population screening of women aged 50-70 y; Italy   38 676   Costs per woman screened; cost per cancer detected   Costs of recruitment, screening, and follow-up from the NHP   N/A   N/A   N/A   de Haes et al., 1991 (228); de Koning et al., 1991 (229)  Screening   CEA   Women of different ages and intervals of screening; The Netherlands   N/A   Costs per LYS; costs per QALYs   Costs and charges; survival; utilities from expert opinion (n = 27) with the use of published literature   Not stated   N/A   N/A   Brown, 1992 (230)  Screening   CEA   Women ≥50 y old; test effects of increasing age; United States   N/A   Costs; LYS   Direct medical costs only; survival based on published literature   N/A   N/A   N/A   Zavertnik et al., 1992 (231)  Screening   Costs of care   Costs of delivering low-cost mammography; United States   9452   Costs per cancer detected   Fixed and variable costs of screening program; cases detected   N/A   N/A   N/A   Mandelblatt et al., 1992 (76)  Screening   Decision analysis/CEA   Women aged ≥65 y with comorbid illnesses; black and white; United States   N/A   Costs; LYS; QALYs   Direct medical costs only; survival based on published literature; utility estimated from expert opinion   Not stated   N/A   N/A   Vaile et al., 1993 (232)  Screening   Longitudinal cohort   Women aged 50-64 y invited for screening who attended and had a negative test; England   2060; 65% response rate; 12% lost to follow-up   Satisfaction   De novo tool   Mail survey   No   No   Roworth et al., 1993 (233)  Screening   Cross-section   Women aged 50-64 y attending screening; Scotland   3000; 86% response rate   Satisfaction with screening; pain and pressure experienced; intention to return   Cockburn Satisfaction With Screening Tool; de novo questions   Mail survey   No   Unknown   Richardson et al., 1994 (234)  Screening   Cross-section   Women aged 50-64 y attending screening in urban and rural areas; New Zealand (included since dealing with satisfaction with screening—very few studies)   474; 93% response rate   Satisfaction with screening; anxiety   De novo tool   Mail survey   No   Unknown   Nutting et al., 1994 (77)  Screening   CEA   Mammogram + CBE vs. CBE in community of 750 American Indian women aged ≥50 y; United States   N/A   Costs; deaths averted; 5-y survival   Indian health service costs; survival based on published literature   N/A   N/A   N/A   Beemsterboer et al., 1994 (235)  Screening   CEA   Women aged 50-69 y; Germany   N/A   Costs per LYS   Direct medical costs; survival with the use of local data   N/A   N/A   N/A   Boer et al., 1995 (236) and 1998 (237)  Screening   CEA   Determination of upper-age limit for screening; The Netherlands   N/A   Costs per QALYs   Direct medical care costs; survival; utilities with the use of published data; source for utilities not described   N/A   N/A   N/A   Brown et al., 1995 (240)  Screening   CEA of nonrandom trial   Screening using one-vs. two-view mammography among women aged 50-64 y; England   26 430   Costs per cancer detected   Costs of screen and diagnostic follow-up in NHS; patient time costs   N/A   N/A   N/A   Feig, 1995 (239)  Screening   CEA   Women aged 40-49 y; United States   N/A   Costs of screening and diagnosis per woman screened or per LYS   Charges and cost estimates based on published literature   N/A   N/A   N/A   Brown et al., 1996 (240)  Screening   CEA   Mammography among women aged 50-64 y; one vs. two readings with or without consensus on films; England   33 734   Costs per cancer detected   Direct medical and nonmedical care costs to NHS and women based on local data   N/A   N/A   N/A   Evans et al., 1996 (241)  Screening   CEA   Women aged 50-64 y; Spain   100 000   Costs per cancer detected   Costs based on local data   N/A   N/A   N/A   Mandelblatt et al., 1997 (78)  Screening   CEA   Women seeking care in an urban public hospital emergency room; United States   N/A   Costs per LYS   Direct medical care costs and hospital charges; survival based on local data and published literature   N/A   N/A   N/A   Salzmann et al., 1997 (242)  Screening   CEA   Women starting mammography at ages 40-49 y vs. 50-69 y; United States   N/A   Costs; LYS   Direct medical costs only; survival based on published literature   N/A   N/A   N/A   Torgerson and Gosden, 1997 (243)  Screening   CEA   Women aged 66-69 y vs. 51-65 y; England   N/A   Deaths averted; LYS   Age-specific effects; number of deaths and survival; assumes resources are equal in the 2 age groups   N/A   N/A   N/A   Warmerdam et al., 1997 (244)  Screening   CEA   Women aged 50-69 y; The Netherlands   N/A   Costs; LYS   Costs in the German HC system; survival based on published literature and local data   N/A   N/A   N/A   Bakker et al., 1998 (245)  Screening   Cross-section; description   Convenient sample of women ≥50 y old (mean age, 61 y; range, 50-85 y) interviewed after mammography; Canada   256; 81% response rate   Satisfaction; distress   PCQ; de novo items   Telephone interview   No   No   Boer et al., 1998 (237)  Screening   CEA   Women living in the northwest region of England   N/A   Preferences/utility; costs; life-years saved; number of deaths prevented   Screening and cost data from the NHS breast-screening program   N/A   N/A   N/A   Gilbert et al., 1998 (246)  Screening   Cohort; longitudinal   Women aged 50-64 y following a false-positive screening mammography; Scotland   124   Psychologic distress   HADS; health questionnaire   Self-administered; mail survey; in-person interview   No   Unknown   Johnston et al., 1998 (206)  Screening   Cross-section   Women aged 40-64 y screened within 6 mo of screen or invited to be screened; England   440   Preferences for temporary states (FP, FN, etc.)   TTO   In-person interview   Yes   Yes   Lamarque et al., 1998 (247)  Screening   CEA   Women aged 40-60 y; France   N/A   Costs per case detected   Direct and non-direct medical costs (travel and time); biopsyproven disease based on local data   N/A   N/A   N/A   Rosenquist and Lindfors, 1998 (248)  Screening   CEA   Women beginning screening at age 40 y at different intervals until age 79 y; United States   N/A   Incremental costs per LYS   Direct medical costs; survival based on published literature   N/A   N/A   N/A   Schweitzer et al., 1998 (79)  Screening   CEA   Low-income black and Hispanic women using a mobile mammography van; United States   N/A   Costs per cancer detected   Microcosting of actual van services; biopsy-proven cancer based on published literature   N/A   N/A   N/A   Boer et al., 1998, (237)  Screening   CEA   Women at 2-y vs. 3-y intervals; stop screening at age 64 y vs. age 69 y; England   N/A   Costs; LYS   NHS costs; survival based on published literature   N/A   N/A   N/A   Wolstenholme et al., 1998 (249)  Screening   CEA   Costs of screening, incorporating the downstream costs of treatment among a regional sample diagnosed in 1991; England   137   Costs; LYS   Costs in the NHS; observed survival based on published literature and local data   N/A   N/A   N/A   Allen et al., 1999 (250)  Screening   CEA   Sestamibi scintimammography for women >40 y old with dense breasts; United States   N/A   Preferences/utility; costs   Single time-point analysis   N/A   N/A   N/A   Boer et al., 1999 (51)  Screening   CEA   Women aged ≥65 y; The Netherlands   N/A   Preferences/ utility; costs; LYS; extra incidence; extra life-years with disease   Data from the Dutch screening projects   N/A   N/A   N/A   Gyrd-Hansen, 1999 (251)  Screening   CEA   Costs of screening for colorectal, cervical, and breast cancers from national health care sector perspective; Denmark   N/A   Preferences/utility; costs   Published data from Swedish and Dutch screening programs and trials   N/A   N/A   N/A   Leivo et al., 1999 (252)  Screening   CEA   Women aged 50-64 y screened in the Finnish nationwide screening program (1987-1992); Finland   90 000   Preferences/utility; costs; LYS   Published studies and national cancer statistics, health market sources   N/A   N/A   N/A   Norum, 1999 (253)  Screening   CEA   Women aged 50-64 y screened every 2 y in a demonstration program; Norway   46 329   Costs per cancer detected; costs per LYS   Costs in the screening project; survival with the use of local data; production gains or losses   N/A   N/A   N/A   Secker-Walker et al., 1999 (91)  Screening   Costs of care   Women attending screening in 2 geographic areas; majority 65-79 y old (range, <50-80+); United States   445; 49% response rate   Patient time and costs associated with screening and diagnosis   Time and travel time; out-of-pocket costs   Telephone interview   No   Unknown   van der Pol et al., 1999 (254)  Screening   CEA   Women in sparsely populated areas; island communities of Scotland   N/A   Preferences/utility; costs   Time and travel costs   N/A   N/A   No   Haas et al., 2000 (84)  Screening   Cross-section   Women who had abnormal mammograms or mammography for clinical breast concern; United States   751; 77% response rate   Quality of care   Cross-sectional patient survey and medical record review   Telephone interview   No   Unknown   View Large Appendix Table 3. Characteristics of studies on the outcomes of diagnosis: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *AND = axillary node dissection; CBE = clinical breast exam; CEA = cost-effectiveness analysis; CNB = core needle biopsy; FNA = fine-needle aspiration; GIVIO = Interdisciplinary Group for Cancer Care Evaluation; MD = medical doctor; N/A = not applicable; QALY = quality-adjusted life years; RCT = randomized controlled trial.   † SeeTable 3 for definitions of abbreviations of measures.   Kennedy et al,. 1991 (255)  Diagnosis   Costs of care   Women being evaluated for staging: England   103   Costs per detection of bone metastases   Costs in NHP   N/A   N/A   N/A   Mosconi et al., 1991 (256)  Diagnosis   Cross-section   Women in GIVIO RCT; stages I, II, and III, age <70 y; Italy   1171: 81.5% response rate   Satisfaction with communication; information received   De novo items   Mail survey   N/A   Unknown   McManus et al., 1992 (257)  Diagnosis   Costs of care   Women with needle localization biopsies for nonpalpable lesions vs. triaging mammograms by probability of malignancy and use of selective biopsy; Canada   332   Costs per biopsy; avoided biopsy costs   Direct costs of biopsy in the national health system   N/A   N/A   N/A   Layfield et al., 1993 (258)  Diagnosis   CEA   FNA vs. open biopsy in women with palpable masses and negative mammography; United States   N/A   Costs per 10-y survival   Diagnostic charges at one center and Medicare costs for ongoing treatment and follow-up; survival   N/A   N/A   N/A   Velanovich, 1995 (259)  Diagnosis   CEA   Immediate biopsy vs. repeat mammagraphy in 6 mo women with abnormal mammograms; United States   N/A   Costs per QALY   Based on published literature   N/A   N/A   N/A   Fajardo, 1996 (260)  Diagnosis   Costs of care   Women with nonpalpable lesions seen on mammography evaluated with stereotaxic core needle biopsy; United, States   400   Costs per case correctly diagnosed vs. delayed vs. missed diagnosis   Costs in one institution based on cost-to-charge ratio   N/A   N/A   N/A   Vetto et al., 1996 (262)  Diagnosis   Costs of care   CBE, sonogram, and FNA vs. CBE and open biopsy for women <40 y old with papable lesions; mean age 33 y; United States   55 (included because of paucity of dx studies)   Costs per correct diagnosis   Charges   N/A   N/A   N/A   Hillner 1997 (262)  Diagnosis   CEA   Sestamibi vs. core biopsy vs. open biopsy in women with nonpalpable lesions; United States   N/A   Costs; number of cancer diagnoses missed; number of delayed diagnoses   Institutional costs; missed or delayed diagnosis of cancer based on published literature and RCT   N/A   N/A   N/A   Rubin et., 1997 (263)  Diagnosis   Costs of care   FNA to avoid open biopsy in women with palpable lesions: United States   N/A   Costs saved per averted biopsy   Biopsy charges   N/A   N/A   N/A   Logan-Young et al., 1998 (264)  Diagnosis   CEA   FNA vs. core vs. open biopsy in one practice; United States   > 40 000 patients   Costs per case diagnosed   Charges based on case series; cancer cases   N/A   N/A   N/A   Velanovich, 1998 (265)  Diagnosis   Decision analysis   AND in patients with lesions <2 cm; United States   N/A   QALYs   Survival; utilities from expert and patient opinion or literature; values not given   N/A   N/A   N/A   Burkhardt and Sunshine, 1999 (266)  Diagnosis   Costs of care   Costs of biopsy methods (core needle and open surgery); United States   N/A   Costs   Costs; charges; actual payments; excludes “overhead costs”   N/A   N/A   N/A   Heimdal et al., 1999 (267)  Diagnosis   CEA   Cost-effectiveness of survelliance program for women at risk for inherited disease; Norway   N/A   Preference/utility; costs   Based on results from surveillance program; Norwegian National Insurance Service reimbursement fees   N/A   N/A   N/A   Hrung et al., 1999 (268)  Diagnosis   CEA   Imaging and CNB Magnetic resonance in the preoperative work-up of suspicious breast lesions; United States   N/A   Preferences/utility; costs   Stage-specific cancer prevalence, tumor recurrence, progression rates, and magnetic resonance imaging and CNB sensitivity and specificity were obtained from published literature. Cost estimates were obtained from the literature and from the Medicare fee schedule   N/A   N/A   N/A   Boer et al., 1999 (51)  Diagnosis   CEA   Two-view mammography at incident screens; England and Wales   N/A   Perferences/utility; costs   Previously collected data from screening programs   N/A   N/A   N/A   Leivo et al., 1999 (269)  Diagnosis   CEA   Nationwide semiannual screening program for women 50-59 y old; Finland   95 423; 91% participation rate   Preferences/utility; costs   All mammographies performed during 1990-1995 in 3 screening centers of the Finnish Cancer Society   N/A   N/A   N/A   Orr et al., 1999 (270)  Diagnosis   CEA   Sentinel node biopsy vs. AND; threshold of accuracy (learning curve); United States   10 000 women per arm   Costs, % correct staging; survival; QALYs;   Costs; survival; MD-rated utility based on published literature   N/A   N/A   N/A   Allen et al., 2000 (49)  Diagnosis   CEA   Sestamibi scintimammography; with mammography; United States   N/A   Preferences/utility; costs   Based on Medicare reimbursement values   N/A   N/A   N/A   Morris et al., 2000 (212)  Diagnosis   CEA   Women who underwent wire-guided open breast biopsy; United States   164   Preferences/utility; costs   Biopsy records review; Current Procedure Terminology-based charges   N/A   N/A   N/A   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *AND = axillary node dissection; CBE = clinical breast exam; CEA = cost-effectiveness analysis; CNB = core needle biopsy; FNA = fine-needle aspiration; GIVIO = Interdisciplinary Group for Cancer Care Evaluation; MD = medical doctor; N/A = not applicable; QALY = quality-adjusted life years; RCT = randomized controlled trial.   † SeeTable 3 for definitions of abbreviations of measures.   Kennedy et al,. 1991 (255)  Diagnosis   Costs of care   Women being evaluated for staging: England   103   Costs per detection of bone metastases   Costs in NHP   N/A   N/A   N/A   Mosconi et al., 1991 (256)  Diagnosis   Cross-section   Women in GIVIO RCT; stages I, II, and III, age <70 y; Italy   1171: 81.5% response rate   Satisfaction with communication; information received   De novo items   Mail survey   N/A   Unknown   McManus et al., 1992 (257)  Diagnosis   Costs of care   Women with needle localization biopsies for nonpalpable lesions vs. triaging mammograms by probability of malignancy and use of selective biopsy; Canada   332   Costs per biopsy; avoided biopsy costs   Direct costs of biopsy in the national health system   N/A   N/A   N/A   Layfield et al., 1993 (258)  Diagnosis   CEA   FNA vs. open biopsy in women with palpable masses and negative mammography; United States   N/A   Costs per 10-y survival   Diagnostic charges at one center and Medicare costs for ongoing treatment and follow-up; survival   N/A   N/A   N/A   Velanovich, 1995 (259)  Diagnosis   CEA   Immediate biopsy vs. repeat mammagraphy in 6 mo women with abnormal mammograms; United States   N/A   Costs per QALY   Based on published literature   N/A   N/A   N/A   Fajardo, 1996 (260)  Diagnosis   Costs of care   Women with nonpalpable lesions seen on mammography evaluated with stereotaxic core needle biopsy; United, States   400   Costs per case correctly diagnosed vs. delayed vs. missed diagnosis   Costs in one institution based on cost-to-charge ratio   N/A   N/A   N/A   Vetto et al., 1996 (262)  Diagnosis   Costs of care   CBE, sonogram, and FNA vs. CBE and open biopsy for women <40 y old with papable lesions; mean age 33 y; United States   55 (included because of paucity of dx studies)   Costs per correct diagnosis   Charges   N/A   N/A   N/A   Hillner 1997 (262)  Diagnosis   CEA   Sestamibi vs. core biopsy vs. open biopsy in women with nonpalpable lesions; United States   N/A   Costs; number of cancer diagnoses missed; number of delayed diagnoses   Institutional costs; missed or delayed diagnosis of cancer based on published literature and RCT   N/A   N/A   N/A   Rubin et., 1997 (263)  Diagnosis   Costs of care   FNA to avoid open biopsy in women with palpable lesions: United States   N/A   Costs saved per averted biopsy   Biopsy charges   N/A   N/A   N/A   Logan-Young et al., 1998 (264)  Diagnosis   CEA   FNA vs. core vs. open biopsy in one practice; United States   > 40 000 patients   Costs per case diagnosed   Charges based on case series; cancer cases   N/A   N/A   N/A   Velanovich, 1998 (265)  Diagnosis   Decision analysis   AND in patients with lesions <2 cm; United States   N/A   QALYs   Survival; utilities from expert and patient opinion or literature; values not given   N/A   N/A   N/A   Burkhardt and Sunshine, 1999 (266)  Diagnosis   Costs of care   Costs of biopsy methods (core needle and open surgery); United States   N/A   Costs   Costs; charges; actual payments; excludes “overhead costs”   N/A   N/A   N/A   Heimdal et al., 1999 (267)  Diagnosis   CEA   Cost-effectiveness of survelliance program for women at risk for inherited disease; Norway   N/A   Preference/utility; costs   Based on results from surveillance program; Norwegian National Insurance Service reimbursement fees   N/A   N/A   N/A   Hrung et al., 1999 (268)  Diagnosis   CEA   Imaging and CNB Magnetic resonance in the preoperative work-up of suspicious breast lesions; United States   N/A   Preferences/utility; costs   Stage-specific cancer prevalence, tumor recurrence, progression rates, and magnetic resonance imaging and CNB sensitivity and specificity were obtained from published literature. Cost estimates were obtained from the literature and from the Medicare fee schedule   N/A   N/A   N/A   Boer et al., 1999 (51)  Diagnosis   CEA   Two-view mammography at incident screens; England and Wales   N/A   Perferences/utility; costs   Previously collected data from screening programs   N/A   N/A   N/A   Leivo et al., 1999 (269)  Diagnosis   CEA   Nationwide semiannual screening program for women 50-59 y old; Finland   95 423; 91% participation rate   Preferences/utility; costs   All mammographies performed during 1990-1995 in 3 screening centers of the Finnish Cancer Society   N/A   N/A   N/A   Orr et al., 1999 (270)  Diagnosis   CEA   Sentinel node biopsy vs. AND; threshold of accuracy (learning curve); United States   10 000 women per arm   Costs, % correct staging; survival; QALYs;   Costs; survival; MD-rated utility based on published literature   N/A   N/A   N/A   Allen et al., 2000 (49)  Diagnosis   CEA   Sestamibi scintimammography; with mammography; United States   N/A   Preferences/utility; costs   Based on Medicare reimbursement values   N/A   N/A   N/A   Morris et al., 2000 (212)  Diagnosis   CEA   Women who underwent wire-guided open breast biopsy; United States   164   Preferences/utility; costs   Biopsy records review; Current Procedure Terminology-based charges   N/A   N/A   N/A   View Large Appendix Table 4. Characteristics of studies on the short-term outcomes of local treatment: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ALND = axillary lymph node dissection; AND = axillary node dissection; CEA = cost-effectiveness analysis; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy.   † SeeTable 3 for definitions of abbreviations of measures.   Verhoef et al., 1991 (271)  Local treatment   CEA   Women receiving BCS vs. MST, compared for recurrence   N/A   Costs per QALY   Costs; survival with the use of published data; source of costs or types of costs not included; no data on how utilities were derived   N/A   N/A   N/A   Ganz et al., 1990 (273), 1992 (73, 272), 1993 (274)  Local treatment   RCT   Women with state I or II cancer enrolled in trial comparing rehabilitation case management with minimal intervention after surgery; compares MST with BCS; 15% black; United States   229 [109 in (73,273)]; 139 in 50% response rate   QOL; symptoms   FLIC; CARES; KPS; POMS; GAIS   In-person interview   No   Unknown   August et al., 1995 (275)  Local treatment   Cross-section   Women attending a multidisciplinary breast cancer service; average age approximately 50 y; United States   601; 59% response rate   Satisfaction   De novo tool   Mail survey   Yes   Unknown   Holcombe et al., 1995 (265)  Local treatment   Cross-section   Women after AND; mean age 59 y (range, 29-76 y), England   101   Satisfaction   De novo tool   Unknown   No   Unknown   Legorreta et al., 1996 (277)  Local treatment   Costs of care   Women with newly diagnosed breast cancers in a health maintenance organization population (U.S. Healthcare, Blue Bell, PA); mean age 54 y (range, 29-82 y); United States   200   4-y costs; clinical stage; use of mammography screening   Medical records; claims data; all health maintenance organization expenditures for non-primary care services   N/A   N/A   N/A   Maunsell et al., 1996 (278)  Local treatment   RCT   Women newly diagnosed with local- or regional-stage disease at 1 regional cancer center from 1990 to 1992; counseling plus monthly telephone screening vs. counseling only; Canada   261; 96% response rate   Distress; QOL; marital satisfaction; return to usual activities   QHC; social support questionnaire; LES; LWMAT; Psychiatric Symptom Index; Canada Health and Activity Limitation Survey   In-person interview; telephone interview   Yes   Unknown   Berry et al., 1998 (279)  Local treatment   Cross-section   Women undergoing breast reconstruction with a prosthesis at a median age of 52 y (range, 25-74 y); England   100   Satisfaction   De novo tool   Mail survey   No   Unknown   Degner et al., 1997 (280)  Local treatment   Cross-section   Women treated for breast cancer seen in 2 cancer centers and 2 community oncology clinics; mean age 58 y (±12.7 y); Canada   1012   Preferences about participation in treatment decisions; information needs   De novo tool   In-person interview   Yes   Unknown   Gabel et al., 1997 (223)  Local treatment   Case-control; historical controls   Patients seen before and after institution of a multidisciplinary breast cancer clinic at a teaching hospital; United States   339; bias: 67% response for control subjects and 44% for case subjects   Satisfaction; time to treatment   Unknown   Mail survey   No   Unknown   Hayman et al., 1997 (281)  Local treatment   Cross-section   Women with stage I or II cancer who underwent BCS plus RT; 6-24 mo after treatment; United States   117   Preferences   Standard Gamble   In-person interview   No   Unknown   Liljegren et al., 1997 (282)  Local treatment   CEA of RCT; 5-y time horizon   Patients with stage I disease who were <80 y old when receiving BCS and AND ± RT; Sweden   381   Incremental costs; QALYs (double counted production loss and disutility)   Direct and nondirect medical costs, production costs; survival; primary data collection; intend to Rx; utility from MDs   N/A   N/A   N/A   Norum et al., 1997 (196)  Local treatment   CEA   Stage I or II; Norway   N/A   Incremental costs; QALYs   Direct and nondirect medical costs based on published literature; survival; patient-rated utility with the use of Euro-QoL   N/A   N/A   N/A   Weitzner et al., 1997 (74)  Local treatment   Cross-section   Women treated with MRM plus adjuvant therapy; age <70 y (mean age 54 y) surviving >5 y from stage I, II, or III breast cancer compared with control subjects with normal screening; 13% black; United States   153   QOL   BDI; STAI; FPQLI   Self-administered   No   Unknown   Andrykowski et al., 1998 (283)  Local treatment   RCT   Women ≥18 y old with a first-time diagnosis of stage 0, I, II, or IIIA disease with a history of fine-needle aspiration and/or diagnosis or fibrocystic disease; United States   176   QOL; fatigue   MOS SF-36; CES-D; Chalder Fatigue Scale; Piper Fatigue Scale; Pittsburgh Sleep Quality Index; Symptom Experience Report   Mail survey   Yes   Unknown   Bonnema et al., 1998 (284)  Local treatment   RCT   RCT of short or long stay in postsurgical hospital; stage I or II disease, follow-up of 4 mo; The Netherlands   125   QOL; satisfaction   De novo items   Self-administered   Yes   Unknown   Bonnema et al., 1998 (284,285)  Local treatment   Cost minimization based on RCT   RCT of short or long stay in postsurgical hospital; stage I or II disease, follow-up of 4 mo; The Netherlands   139; 79 completed 4-month diaries   Costs per arm 4-mo postsurgical period   Direct and nondirect medical costs; patient diaries for resource use; national costs   Self-administered   N/A   N/A   Hayman et al., 1998 (286)  Local treatment   CEA using local and published data   Compare RT after BCS with no RT in a cohort of 60-y-old women; United States   N/A   Costs per QALY   Charges at one institution and nonmedical directs (time, travel); survival; utilities; standard gamble in a sample of 97 patients   N/A   N/A   N/A   Maslin et al., 1998 (287)  Local treatment   RCT   Women with local disease and mean age 52 y (range, 28-73 y) randomly assigned to interactive video support plus team vs. multidisciplinary shared decision-making; England   100; subset response rate 94% for QOL   QOL; acceptability of video   MOS SF-36; HADS; de novo tool satisfaction   Self-administered   No   Unknown   Burstein et al., 1999 (288)  Local treatment   Longitudinal cohort   Women with stages I or II disease; United States   480; 69% response rate; 73% completed follow-up   QOL; use of alternative medicine   MOS SF-36; MOS sexual satisfaction; CES-D; NCPT symptom checklist; Lasry and Margoles Fear of Recurrence Scale   In-person interview   No   Unknown   Frost et al., 1999 (289)  Local treatment   Cross-section   Newly diagnosed women who received their medical oncology consult in a hospital vs. in a multidisciplinary outpatient clinic; United States   121; 72% response rate   QOL; satisfaction   CARES; de novo tool   Self-administered   Yes   Unknown   Ganz et al., 1999 (81)  Local treatment   Cross-section   Women in a partnered relationship and sexually active in the past 6 mo with a diagnosis of stage 0, I, or II disease; living in Los Angeles, CA, or in Washington, DC; United States   1134   Sexual health   CARES Body Image Subscale; Sexual Functioning Inventory Scale; Sexual Interest and Dysfunction Subscale; BCPT Symptom Checklist; revised DAS; RAND Health Survey; WSFQ   Mail survey   No   Unknown   Hack et al., 1999 (290)  Local treatment   Cross-section   Women who had ALND at least 6 mo before without advanced disease; Canada   89.5% response rate   QOL; pain; mental health   Range of arm/shoulder motion; modified Postoperative Pain Questionnaire; PDI; short-form McGill Pain Questionnaire; EORTC QLQ-C30   In-person interview   No   Unknown   Marks et al., 1999 (65)  Local treatment   CEA   Women undergoing postmastectomy RT; United States   N/A   Cost per QALY; cost per averted relapse   Charges; nonmedical direct costs of time and travel; survival with the use of published literature   N/A   N/A   N/A   Pusic et al., 1999 (83)  Local treatment   Cross-section   Women who had a lumpectomy with RT or a mastectomy listed in the hospital tumor registry and plastic surgery clinical records; United States and Canada   525; 50.9% response rate   QOL; patient choice   MOS SF-36; Illness Intrusiveness Scale   Self-administered   No   Unknown   Shimozuma et al., 1999 (86)  Local treatment   RCT   Women who lived in Los Angeles County, CA; randomly assigned to MRM vs. BCT; United States   227   QOL   CARES; KPS; POMS   In-person interview   No   Unknown   Wang et al., 1999 (75)  Local treatment   Cross-section   Women seen for first follow-up after surgery; mean age 49 y (range, 27-78 y); 84% white; United States   102   QOL; concerns and needs   De novo tool   In-person interview   No   Unknown   Wengstrom et al., 1999 (291)  Local treatment   RCT   Women beginning curative RT; Sweden   175; 77% response rate   QOL   IES; OTTAT; CARES—short form   In-person interview; mail survey   Yes   Unknown   Wenzel 1999 (292)  Local treatment   Cross-section   Subset from intervention trial testing the efficacy of a telephone counseling program; United States   354; 86% response rate   QOL   CES-D; IES; Breast FACT-B; Sexual Functioning and Body Images Scale   Mail survey   Yes   Unknown   Hayman et al., 2000 (293)  Local treatment   CEA   Women with negative margins after conservative surgery who experienced an addition of an electrobeam boost to tangential RT; United States   N/A   Preferences/utility; costs; QALYS   Based on the Lyon trial   N/A   N/A   N/A   Mille et al., 2000 (294)  Local treatment   Costs of care   Compliant vs. noncompliant clinical practice guidelines; France   200   Cost evaluation from Social Security perspective; in medical practice   Number of medical procedures performed; medical records   N/A   N/A   Unknown   Palit et al., 2000 (295)  Local treatment   Costs of care   Women having breast conservation surgery or modified radical mastectomy; United States   230   Costs   Medical records and billing   N/A   N/A   Unknown   Whelan et al., 2000 (296)  Local treatment   RCT   Women treated by lumpectomy and ALND referred to specific cancer centers; Canada   837; 75% response rate at follow-up   QOL   Breast Cancer Chemotherapy Questionnaire (BCQ)   In-person interview   No   Unknown   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ALND = axillary lymph node dissection; AND = axillary node dissection; CEA = cost-effectiveness analysis; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy.   † SeeTable 3 for definitions of abbreviations of measures.   Verhoef et al., 1991 (271)  Local treatment   CEA   Women receiving BCS vs. MST, compared for recurrence   N/A   Costs per QALY   Costs; survival with the use of published data; source of costs or types of costs not included; no data on how utilities were derived   N/A   N/A   N/A   Ganz et al., 1990 (273), 1992 (73, 272), 1993 (274)  Local treatment   RCT   Women with state I or II cancer enrolled in trial comparing rehabilitation case management with minimal intervention after surgery; compares MST with BCS; 15% black; United States   229 [109 in (73,273)]; 139 in 50% response rate   QOL; symptoms   FLIC; CARES; KPS; POMS; GAIS   In-person interview   No   Unknown   August et al., 1995 (275)  Local treatment   Cross-section   Women attending a multidisciplinary breast cancer service; average age approximately 50 y; United States   601; 59% response rate   Satisfaction   De novo tool   Mail survey   Yes   Unknown   Holcombe et al., 1995 (265)  Local treatment   Cross-section   Women after AND; mean age 59 y (range, 29-76 y), England   101   Satisfaction   De novo tool   Unknown   No   Unknown   Legorreta et al., 1996 (277)  Local treatment   Costs of care   Women with newly diagnosed breast cancers in a health maintenance organization population (U.S. Healthcare, Blue Bell, PA); mean age 54 y (range, 29-82 y); United States   200   4-y costs; clinical stage; use of mammography screening   Medical records; claims data; all health maintenance organization expenditures for non-primary care services   N/A   N/A   N/A   Maunsell et al., 1996 (278)  Local treatment   RCT   Women newly diagnosed with local- or regional-stage disease at 1 regional cancer center from 1990 to 1992; counseling plus monthly telephone screening vs. counseling only; Canada   261; 96% response rate   Distress; QOL; marital satisfaction; return to usual activities   QHC; social support questionnaire; LES; LWMAT; Psychiatric Symptom Index; Canada Health and Activity Limitation Survey   In-person interview; telephone interview   Yes   Unknown   Berry et al., 1998 (279)  Local treatment   Cross-section   Women undergoing breast reconstruction with a prosthesis at a median age of 52 y (range, 25-74 y); England   100   Satisfaction   De novo tool   Mail survey   No   Unknown   Degner et al., 1997 (280)  Local treatment   Cross-section   Women treated for breast cancer seen in 2 cancer centers and 2 community oncology clinics; mean age 58 y (±12.7 y); Canada   1012   Preferences about participation in treatment decisions; information needs   De novo tool   In-person interview   Yes   Unknown   Gabel et al., 1997 (223)  Local treatment   Case-control; historical controls   Patients seen before and after institution of a multidisciplinary breast cancer clinic at a teaching hospital; United States   339; bias: 67% response for control subjects and 44% for case subjects   Satisfaction; time to treatment   Unknown   Mail survey   No   Unknown   Hayman et al., 1997 (281)  Local treatment   Cross-section   Women with stage I or II cancer who underwent BCS plus RT; 6-24 mo after treatment; United States   117   Preferences   Standard Gamble   In-person interview   No   Unknown   Liljegren et al., 1997 (282)  Local treatment   CEA of RCT; 5-y time horizon   Patients with stage I disease who were <80 y old when receiving BCS and AND ± RT; Sweden   381   Incremental costs; QALYs (double counted production loss and disutility)   Direct and nondirect medical costs, production costs; survival; primary data collection; intend to Rx; utility from MDs   N/A   N/A   N/A   Norum et al., 1997 (196)  Local treatment   CEA   Stage I or II; Norway   N/A   Incremental costs; QALYs   Direct and nondirect medical costs based on published literature; survival; patient-rated utility with the use of Euro-QoL   N/A   N/A   N/A   Weitzner et al., 1997 (74)  Local treatment   Cross-section   Women treated with MRM plus adjuvant therapy; age <70 y (mean age 54 y) surviving >5 y from stage I, II, or III breast cancer compared with control subjects with normal screening; 13% black; United States   153   QOL   BDI; STAI; FPQLI   Self-administered   No   Unknown   Andrykowski et al., 1998 (283)  Local treatment   RCT   Women ≥18 y old with a first-time diagnosis of stage 0, I, II, or IIIA disease with a history of fine-needle aspiration and/or diagnosis or fibrocystic disease; United States   176   QOL; fatigue   MOS SF-36; CES-D; Chalder Fatigue Scale; Piper Fatigue Scale; Pittsburgh Sleep Quality Index; Symptom Experience Report   Mail survey   Yes   Unknown   Bonnema et al., 1998 (284)  Local treatment   RCT   RCT of short or long stay in postsurgical hospital; stage I or II disease, follow-up of 4 mo; The Netherlands   125   QOL; satisfaction   De novo items   Self-administered   Yes   Unknown   Bonnema et al., 1998 (284,285)  Local treatment   Cost minimization based on RCT   RCT of short or long stay in postsurgical hospital; stage I or II disease, follow-up of 4 mo; The Netherlands   139; 79 completed 4-month diaries   Costs per arm 4-mo postsurgical period   Direct and nondirect medical costs; patient diaries for resource use; national costs   Self-administered   N/A   N/A   Hayman et al., 1998 (286)  Local treatment   CEA using local and published data   Compare RT after BCS with no RT in a cohort of 60-y-old women; United States   N/A   Costs per QALY   Charges at one institution and nonmedical directs (time, travel); survival; utilities; standard gamble in a sample of 97 patients   N/A   N/A   N/A   Maslin et al., 1998 (287)  Local treatment   RCT   Women with local disease and mean age 52 y (range, 28-73 y) randomly assigned to interactive video support plus team vs. multidisciplinary shared decision-making; England   100; subset response rate 94% for QOL   QOL; acceptability of video   MOS SF-36; HADS; de novo tool satisfaction   Self-administered   No   Unknown   Burstein et al., 1999 (288)  Local treatment   Longitudinal cohort   Women with stages I or II disease; United States   480; 69% response rate; 73% completed follow-up   QOL; use of alternative medicine   MOS SF-36; MOS sexual satisfaction; CES-D; NCPT symptom checklist; Lasry and Margoles Fear of Recurrence Scale   In-person interview   No   Unknown   Frost et al., 1999 (289)  Local treatment   Cross-section   Newly diagnosed women who received their medical oncology consult in a hospital vs. in a multidisciplinary outpatient clinic; United States   121; 72% response rate   QOL; satisfaction   CARES; de novo tool   Self-administered   Yes   Unknown   Ganz et al., 1999 (81)  Local treatment   Cross-section   Women in a partnered relationship and sexually active in the past 6 mo with a diagnosis of stage 0, I, or II disease; living in Los Angeles, CA, or in Washington, DC; United States   1134   Sexual health   CARES Body Image Subscale; Sexual Functioning Inventory Scale; Sexual Interest and Dysfunction Subscale; BCPT Symptom Checklist; revised DAS; RAND Health Survey; WSFQ   Mail survey   No   Unknown   Hack et al., 1999 (290)  Local treatment   Cross-section   Women who had ALND at least 6 mo before without advanced disease; Canada   89.5% response rate   QOL; pain; mental health   Range of arm/shoulder motion; modified Postoperative Pain Questionnaire; PDI; short-form McGill Pain Questionnaire; EORTC QLQ-C30   In-person interview   No   Unknown   Marks et al., 1999 (65)  Local treatment   CEA   Women undergoing postmastectomy RT; United States   N/A   Cost per QALY; cost per averted relapse   Charges; nonmedical direct costs of time and travel; survival with the use of published literature   N/A   N/A   N/A   Pusic et al., 1999 (83)  Local treatment   Cross-section   Women who had a lumpectomy with RT or a mastectomy listed in the hospital tumor registry and plastic surgery clinical records; United States and Canada   525; 50.9% response rate   QOL; patient choice   MOS SF-36; Illness Intrusiveness Scale   Self-administered   No   Unknown   Shimozuma et al., 1999 (86)  Local treatment   RCT   Women who lived in Los Angeles County, CA; randomly assigned to MRM vs. BCT; United States   227   QOL   CARES; KPS; POMS   In-person interview   No   Unknown   Wang et al., 1999 (75)  Local treatment   Cross-section   Women seen for first follow-up after surgery; mean age 49 y (range, 27-78 y); 84% white; United States   102   QOL; concerns and needs   De novo tool   In-person interview   No   Unknown   Wengstrom et al., 1999 (291)  Local treatment   RCT   Women beginning curative RT; Sweden   175; 77% response rate   QOL   IES; OTTAT; CARES—short form   In-person interview; mail survey   Yes   Unknown   Wenzel 1999 (292)  Local treatment   Cross-section   Subset from intervention trial testing the efficacy of a telephone counseling program; United States   354; 86% response rate   QOL   CES-D; IES; Breast FACT-B; Sexual Functioning and Body Images Scale   Mail survey   Yes   Unknown   Hayman et al., 2000 (293)  Local treatment   CEA   Women with negative margins after conservative surgery who experienced an addition of an electrobeam boost to tangential RT; United States   N/A   Preferences/utility; costs; QALYS   Based on the Lyon trial   N/A   N/A   N/A   Mille et al., 2000 (294)  Local treatment   Costs of care   Compliant vs. noncompliant clinical practice guidelines; France   200   Cost evaluation from Social Security perspective; in medical practice   Number of medical procedures performed; medical records   N/A   N/A   Unknown   Palit et al., 2000 (295)  Local treatment   Costs of care   Women having breast conservation surgery or modified radical mastectomy; United States   230   Costs   Medical records and billing   N/A   N/A   Unknown   Whelan et al., 2000 (296)  Local treatment   RCT   Women treated by lumpectomy and ALND referred to specific cancer centers; Canada   837; 75% response rate at follow-up   QOL   Breast Cancer Chemotherapy Questionnaire (BCQ)   In-person interview   No   Unknown   View Large Appendix Table 5. Characteristics of studies on the outcomes of adjuvant therapy; January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *BMT = bone marrow transplant; CAF = combination chemotherapy with cyclophosphamide, doxorubicin, and 5-fluorouracil; CEA = cost-effectiveness analysis; CMF = combination chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil; EORTC = European Organization for Research and Treatment of Cancer; ER = estrogen receptor; LYS = life years saved; MD = medical doctor; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy.   † SeeTable 3 for definitions of abbreviations of measures.   Berglund et al., 1991 (297)  Adjuvant therapy   RCT; 2- to 10-y follow-up   Relapse-free survivors initially randomly assigned to receive RT vs. RT plus tamoxifen vs. adjuvant chemotherapy after MST; >3 cm; lymph node positive; age <65 y; mean age 58 y; Sweden; bias: excluded women with recurrences   448; 82% response rate   QOL   de novo tool; HADS; 32 symptoms   Mail survey   Yes for HADS   Unknown   Gelber et al., 1991 (298)  Adjuvant therapy   RCT   Women with lymph node-positive cancer; 1 vs. 6 cycles of chemotherapy plus tamoxifen; Europe   1229   QOL   Qtwist   Self and MD rated   No   Unknown   Love et al., 1991 (299)  Adjuvant treatment   RCT   Postmenopausal women <65 y old; lymph node-negative disease; 10 y after diagnosis; United States   140   QOL; symptoms   Gynecologic symptoms; de novo tools about QOL and anxiety   In-person interview   No   Unknown   Campora et al., 1992 (300)  Adjuvant treatment   Cross-section   Women undergoing chemotherapy (35 with metastatic disease); mean age 55 y (range, 30-70 y); Italy   137   QOL   De novo tool; physical, emotional, social, and symptom domains   In-person interview   No   Unknown   Hillner and Smith, 1992 (301); Hillner et al., 1993 (302); Smith and Hillner, 1993 (303); Hillner and Smith, 1992 (304); Hillner and Smith, 1991 (305)  Adjuvant treatment   CEA of published RCT data   Effects of using chemotherapy in women aged 45-80 y by lymph node and ER status; United States   N/A   Cost per LYS and QALYs   Direct medical care costs based on one hospital's charges and Medicare data; survival; physician-estimated utility   N/A   N/A   N/A   Hurny et al., 1992 (87)  Adjuvant therapy   RCT   Women receiving different numbers and timing of adjuvant chemotherapy cycles (3 vs. 6 and late reintroduction vs. not); Europe   854; 87% complete one QOL set; decrease to 70% over time   QOL   PACIS; LRS; bFs; POMS; HADS; translated into 11 languages   Self-administered   Yes   Unknown   Soukop et al., 1992 (207)  Adjuvant therapy   RCT   Women receiving chemotherapy; randomly assigned to receive ondansetron vs. metoclopramide; England   187   Emesis   Rates of emesis; severity of nausea   Self-administered   No   Yes   Clavel et al., 1993 (306)  Adjuvant therapy   RCT   Women receiving first course of chemotherapy and participating in 5 RCTs of ondansetron vs. placebo or metclopramide and alizapride   689   QOL; symptoms   RSCL; FLIC; FLIC emesis   Unknown   No   Unknown   Cox and Hirsch 1993 (307)  Adjuvant therapy   CEA   Comparison of ondansetron and metoclopramide in women receiving chemotherapy; United States   N/A   Costs per successfully treated patient (i.e., no emesis)   Average costs of drugs and medications to control adverse effects; time of providers caring for patients   N/A   N/A   N/A   Desch et al., 1993 (93)  Adjuvant therapy   CEA   Chemotherapy vs. no adjuvant therapy for women aged 60-80 y with ER-negative stage I cancer   N/A   Cost per LYS and QALYs; cost per active life expectancy   Direct medical care costs based on one hospital's charges and Medicare data; survival with the use of published data; physician-estimated utility   N/A   N/A   N/A   Mapelli et al., 1994 (308)  Adjuvant therapy   Costs of care in an RCT   Women with inflammatory breast cancer randomly assigned to receive high-dose FEC with or without lenograstim; Europe   120   Costs of care   Costs of direct medical resources consumed in the RCT   N/A   N/A   N/A   Clavel et al., 1995 (50)  Adjuvant therapy   RCT   Women receiving first course of chemotherapy and participating in RCT of ondansetron vs. alizapride to prevent emesis; France   254   QOL; symptoms   Symptom checklist; FLIC; FLIC emesis   Self-administered; in-person interview   No   Unknown   Barrenetxea et al., 1996 (309)  Adjuvant therapy   RCT   Women receiving mild emetogenic chemotherapy regimens; Spain   Unknown   QOL; emesis   FLIC; de novo tool   In-person interview   No   Unknown   Gelber et al., 1996 (310), 1998 (298)  Adjuvant therapy   RCT   Postmenopausal women aged ≥50 y with lymph node-positive disease; EBCTCG; standard chemotherapy plus tamoxifen vs. tamoxifen alone; Europe   3920   QOL   Qtwist; source of utility estimates not provided   N/A   N/A   Unknown   Hurny et al., 1996 (89)  Adjuvant therapy   RCT   Lymph node-positive women receiving CMF and booster cycles vs. CMF or CMF vs. tamoxifen; 10 languages; Europe   1248 premenopausal (85% response rate); 998 postmenopausal (83% response rate)   QOL   PACIS; bFs; LRS   Self-administered in clinic   No   Unknown   Lokich et al., 1996 (311)  Adjuvant therapy   Costs of care   Women receiving bolus vs. infusion administration of chemotherapy; United States   N/A   Cost per mode of administration   Charges including MD and/or clinic visit; laboratory; drug cost based on average wholesale price; cost of disposables; and pump rental fee   N/A   N/A   N/A   Longman et al., 1996 (312)  Adjuvant therapy   Cross-section   Women with mean age 55 y (range, 25-82 y) with all stages of disease; recent diagnosis and recurrences; United States   307   QOL   Side effects checklist; de Groot's Symptom Transition Scale; IARB; SCIWPR; Negative Affect Scale; IWB; Cantrill's Ladder   Unknown   Yes   Unknown   Messori et al., 1996 (313)  Adjuvant therapy   CEA using RCT data   CMF chemotherapy vs. none in women with lymph node-positive disease; Italy   388   Costs; LYS   Direct medical costs; survival “area under the curve” estimated by Gompertz function; assumes downstream costs are equal in both arms; no discounting   N/A   N/A   N/A   Hann et al., 1997 (314)  Adjuvant therapy; BMT   Case-control   Cancer center patients with BMT from 1990 to 1995; mean age 44 y (range, 32-57 y); United States   103; 86% response rate   QOL   MOS SF-36; KPS; MSAS   Mail survey   No   Unknown   Bernhard et al., 1998 (88); Hurny et al., 1996 (89)  Adjuvant therapy   RCT   Premenopausal women with lymph node-positive disease receiving CMF plus late CMF vs. CMF or postmenopausal women receiving tamoxifen vs. CMF (with or without delay booster); 9 languages; Europe   2687; subset response rate 82% for QOL   QOL   PACIS; LRS; bFs   Self-administered   No   Unknown   Carter et al., 1998 (315)  Adjuvant therapy   CEA   Treatment of early-stage breast cancer in the elderly; United States   N/A   Preference/utility; costs   Literature data; utilities were determined from the responses of health care professionals to a basic reference gamble   N/A   N/A   N/A   Fetting et al., 1998 (219)  Adjuvant therapy   RCT   Women with lymph node-positive, ER-negative disease randomly assigned to receive CAF in six cycles vs. 16 wk (16 wk includes methotrexate and vincristine); median age 47 y (range, 25-78 y); 15% black; United States   646; QOL data only available on 163; 87% complete all time points   QOL   BCQ   Unknown   No   Unknown   Frits et al., 1998 (316)  Adjuvant therapy   RCT   Women <55 y old with lymph node-positive cancer receiving tamoxifen plus standard chemotherapy vs. tamoxifen plus high-dose chemotherapy; controls without chemotherapy; The Netherlands   121   Cognitive impairment; QOL   Rey Auditory Verbal Learning Test; Complex Figure Test; digit span of WAIS; Trial Making; D2 test; Dutch aphasia test; Stroop Test; Fepsy Tests; EORTC-QLQ-C30; HSCL   In-person interview   No   Unknown   Bernhard et al., 1999 (317)  Adjuvant therapy   RCT   Women who failed prior adjuvant and/or palliative treatment with tamoxifen; randomly assigned to receive forestane vs. megestrol acetate; Switzerland   177; 83% response rate   QOL   De novo tools   Mail survey   No   Unknown   Day et al., 1999 (318)  Adjuvant therapy   Cohort   Women enrolled in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial   82% response rate   QOL   HRQL survey   Self-administered   No   Unknown   Fairclough et al., 1999 (82)  Adjuvant therapy   RCT   Women with hormone-reecptor-negative, lymph node-positive disease; United States   163; 87% response rate   QOL; quality-adjusted survival   Breast Chemotherapy Questionnaire (BCQ)   Self-administered   Yes   No   Gaston-Johansson et al., 1999 (319)  Adjuvant therapy   Cross-section   Women with stage II, III, or IV disease who were scheduled for autologous bone marrow/peripheral blood stem cell transplant; United States   127   Fatigue; pain; depression   Piper Fatigue Scale; MOS Short-form General Health Survey; Gaston-Johannsson Pain-O-Meter   Self-administered   No   Unknown   Hoerger et al., 1999 (320)  Adjuvant therapy   Costs of care   Women ≥45 y old using health care for cardiovascular disease, osteoporosis, breast cancer, or gynecologic cancers; United States   N/A   Costs; health care use   Data from Healthcare Cost and Utilization Project-3 (HCUP-3); national health care survey; discharge data; cost/charge ratios; Medicare fee schedule   N/A   N/A   N/A   Kurtz et al., 1999 (92)  Adjuvant therapy   Longitudinal cohort   Women >65 y old recruited for on-going study of 6 centers in Michigan; United States   383   QOL; comorbidity   MOS SF-36; Symptom Experience Scale   Unknown   No   Unknown   Macquart-Moulin et al., 1999 (321)  Adjuvant therapy   RCT   Women with <9 involved axillary lymph nodes; France   109; subset of 97 at follow-up   QOL; side effects   EORTC QLQ-C30; de novo tool   Self-administered   Yes   No   McKinna et al., 1999 (322)  Adjuvant therapy   RCT   Women with operable breast cancer and suitable for breast-conserving surgery (Jan. 1984-Dec. 1994) who were recommended a policy of observation to the lymphatic pathways; United Kingdom   291   Cancer-related morbidity   Case record review   N/A   N/A   N/A   Silber et al., 1998 (323)  Adjuvant therapy   CEA   Hypothetical cohort of women receiving chemotherapy; use of G-STF to prevent development of neutropenia; United States   N/A   Costs per LYS   Payor charges; survival with the use of published literature   N/A   N/A   N/A   Van Tiggelen et al., 1999 (324)  Adjuvant therapy   CEA   Comparison of oophorectomy with chemotherapy in premenopausal women; Belgium   N/A   Costs (assume equal effects based on one RCT)   Charges with the use of country-specified data   N/A   N/A   N/A   van Enckevort et al., 1999 (325)  Adjuant therapy   CEA   Women receiving chemotherapy, hormonal treatment, or both; The Netherlands   N/A   QALY; costs, preference/utility   Published studies (Jan 1980-Dec 1997)   N/A   N/A   N/A   Joly et al., 2000 (209)  Adjuvant therapy   RCT   Premenopausal women enrolled in a trial testing the efficacy of adjuvant CMF chemotherapy; lymph node negative; France   179; 68% response rate   QOL   EORTC QLQ-C30; EORTC QLQ-BR23   Mail survey   Yes   Unknown   Kramer et al., 2000 (326)  Adjuvant therapy   RCT   Women with baseline QL data from a trial of paclitaxel vs. doxorubicin as first-line chemotherapy; The Netherlands and Belgium   294; 64% response rate   QOL; survival effectiveness   EORTC QLQ-C30; RSCL   Self-administered   No   Unknown   Norum, 2000 (327)  Adjuvant therapy   CEA   Treatment with CMF; Norway   778 articles   QOL; preferences/utility; costs   MEDLINE English language literature with incorporated Norwegian Standard Act practice and cost data   N/A   N/A   N/A   Pandya et al., 2000 (328)  Adjuvant therapy   RCT   Postmenopausal patients experiencing at least one tamoxifen-induced hot flash per day; United States   194   QOL   Diary; de novo tools   Mail survey   No   No   Vrieling et al., 2000 (329)  Adjuvant therapy   RCT   Subset of women entered in the EORTC “boost vs. no-boost” trial of tumorectomy axillary dissection   1872   Cosmetic results   De novo tools   In-person interview   No   Unknown   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *BMT = bone marrow transplant; CAF = combination chemotherapy with cyclophosphamide, doxorubicin, and 5-fluorouracil; CEA = cost-effectiveness analysis; CMF = combination chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil; EORTC = European Organization for Research and Treatment of Cancer; ER = estrogen receptor; LYS = life years saved; MD = medical doctor; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy.   † SeeTable 3 for definitions of abbreviations of measures.   Berglund et al., 1991 (297)  Adjuvant therapy   RCT; 2- to 10-y follow-up   Relapse-free survivors initially randomly assigned to receive RT vs. RT plus tamoxifen vs. adjuvant chemotherapy after MST; >3 cm; lymph node positive; age <65 y; mean age 58 y; Sweden; bias: excluded women with recurrences   448; 82% response rate   QOL   de novo tool; HADS; 32 symptoms   Mail survey   Yes for HADS   Unknown   Gelber et al., 1991 (298)  Adjuvant therapy   RCT   Women with lymph node-positive cancer; 1 vs. 6 cycles of chemotherapy plus tamoxifen; Europe   1229   QOL   Qtwist   Self and MD rated   No   Unknown   Love et al., 1991 (299)  Adjuvant treatment   RCT   Postmenopausal women <65 y old; lymph node-negative disease; 10 y after diagnosis; United States   140   QOL; symptoms   Gynecologic symptoms; de novo tools about QOL and anxiety   In-person interview   No   Unknown   Campora et al., 1992 (300)  Adjuvant treatment   Cross-section   Women undergoing chemotherapy (35 with metastatic disease); mean age 55 y (range, 30-70 y); Italy   137   QOL   De novo tool; physical, emotional, social, and symptom domains   In-person interview   No   Unknown   Hillner and Smith, 1992 (301); Hillner et al., 1993 (302); Smith and Hillner, 1993 (303); Hillner and Smith, 1992 (304); Hillner and Smith, 1991 (305)  Adjuvant treatment   CEA of published RCT data   Effects of using chemotherapy in women aged 45-80 y by lymph node and ER status; United States   N/A   Cost per LYS and QALYs   Direct medical care costs based on one hospital's charges and Medicare data; survival; physician-estimated utility   N/A   N/A   N/A   Hurny et al., 1992 (87)  Adjuvant therapy   RCT   Women receiving different numbers and timing of adjuvant chemotherapy cycles (3 vs. 6 and late reintroduction vs. not); Europe   854; 87% complete one QOL set; decrease to 70% over time   QOL   PACIS; LRS; bFs; POMS; HADS; translated into 11 languages   Self-administered   Yes   Unknown   Soukop et al., 1992 (207)  Adjuvant therapy   RCT   Women receiving chemotherapy; randomly assigned to receive ondansetron vs. metoclopramide; England   187   Emesis   Rates of emesis; severity of nausea   Self-administered   No   Yes   Clavel et al., 1993 (306)  Adjuvant therapy   RCT   Women receiving first course of chemotherapy and participating in 5 RCTs of ondansetron vs. placebo or metclopramide and alizapride   689   QOL; symptoms   RSCL; FLIC; FLIC emesis   Unknown   No   Unknown   Cox and Hirsch 1993 (307)  Adjuvant therapy   CEA   Comparison of ondansetron and metoclopramide in women receiving chemotherapy; United States   N/A   Costs per successfully treated patient (i.e., no emesis)   Average costs of drugs and medications to control adverse effects; time of providers caring for patients   N/A   N/A   N/A   Desch et al., 1993 (93)  Adjuvant therapy   CEA   Chemotherapy vs. no adjuvant therapy for women aged 60-80 y with ER-negative stage I cancer   N/A   Cost per LYS and QALYs; cost per active life expectancy   Direct medical care costs based on one hospital's charges and Medicare data; survival with the use of published data; physician-estimated utility   N/A   N/A   N/A   Mapelli et al., 1994 (308)  Adjuvant therapy   Costs of care in an RCT   Women with inflammatory breast cancer randomly assigned to receive high-dose FEC with or without lenograstim; Europe   120   Costs of care   Costs of direct medical resources consumed in the RCT   N/A   N/A   N/A   Clavel et al., 1995 (50)  Adjuvant therapy   RCT   Women receiving first course of chemotherapy and participating in RCT of ondansetron vs. alizapride to prevent emesis; France   254   QOL; symptoms   Symptom checklist; FLIC; FLIC emesis   Self-administered; in-person interview   No   Unknown   Barrenetxea et al., 1996 (309)  Adjuvant therapy   RCT   Women receiving mild emetogenic chemotherapy regimens; Spain   Unknown   QOL; emesis   FLIC; de novo tool   In-person interview   No   Unknown   Gelber et al., 1996 (310), 1998 (298)  Adjuvant therapy   RCT   Postmenopausal women aged ≥50 y with lymph node-positive disease; EBCTCG; standard chemotherapy plus tamoxifen vs. tamoxifen alone; Europe   3920   QOL   Qtwist; source of utility estimates not provided   N/A   N/A   Unknown   Hurny et al., 1996 (89)  Adjuvant therapy   RCT   Lymph node-positive women receiving CMF and booster cycles vs. CMF or CMF vs. tamoxifen; 10 languages; Europe   1248 premenopausal (85% response rate); 998 postmenopausal (83% response rate)   QOL   PACIS; bFs; LRS   Self-administered in clinic   No   Unknown   Lokich et al., 1996 (311)  Adjuvant therapy   Costs of care   Women receiving bolus vs. infusion administration of chemotherapy; United States   N/A   Cost per mode of administration   Charges including MD and/or clinic visit; laboratory; drug cost based on average wholesale price; cost of disposables; and pump rental fee   N/A   N/A   N/A   Longman et al., 1996 (312)  Adjuvant therapy   Cross-section   Women with mean age 55 y (range, 25-82 y) with all stages of disease; recent diagnosis and recurrences; United States   307   QOL   Side effects checklist; de Groot's Symptom Transition Scale; IARB; SCIWPR; Negative Affect Scale; IWB; Cantrill's Ladder   Unknown   Yes   Unknown   Messori et al., 1996 (313)  Adjuvant therapy   CEA using RCT data   CMF chemotherapy vs. none in women with lymph node-positive disease; Italy   388   Costs; LYS   Direct medical costs; survival “area under the curve” estimated by Gompertz function; assumes downstream costs are equal in both arms; no discounting   N/A   N/A   N/A   Hann et al., 1997 (314)  Adjuvant therapy; BMT   Case-control   Cancer center patients with BMT from 1990 to 1995; mean age 44 y (range, 32-57 y); United States   103; 86% response rate   QOL   MOS SF-36; KPS; MSAS   Mail survey   No   Unknown   Bernhard et al., 1998 (88); Hurny et al., 1996 (89)  Adjuvant therapy   RCT   Premenopausal women with lymph node-positive disease receiving CMF plus late CMF vs. CMF or postmenopausal women receiving tamoxifen vs. CMF (with or without delay booster); 9 languages; Europe   2687; subset response rate 82% for QOL   QOL   PACIS; LRS; bFs   Self-administered   No   Unknown   Carter et al., 1998 (315)  Adjuvant therapy   CEA   Treatment of early-stage breast cancer in the elderly; United States   N/A   Preference/utility; costs   Literature data; utilities were determined from the responses of health care professionals to a basic reference gamble   N/A   N/A   N/A   Fetting et al., 1998 (219)  Adjuvant therapy   RCT   Women with lymph node-positive, ER-negative disease randomly assigned to receive CAF in six cycles vs. 16 wk (16 wk includes methotrexate and vincristine); median age 47 y (range, 25-78 y); 15% black; United States   646; QOL data only available on 163; 87% complete all time points   QOL   BCQ   Unknown   No   Unknown   Frits et al., 1998 (316)  Adjuvant therapy   RCT   Women <55 y old with lymph node-positive cancer receiving tamoxifen plus standard chemotherapy vs. tamoxifen plus high-dose chemotherapy; controls without chemotherapy; The Netherlands   121   Cognitive impairment; QOL   Rey Auditory Verbal Learning Test; Complex Figure Test; digit span of WAIS; Trial Making; D2 test; Dutch aphasia test; Stroop Test; Fepsy Tests; EORTC-QLQ-C30; HSCL   In-person interview   No   Unknown   Bernhard et al., 1999 (317)  Adjuvant therapy   RCT   Women who failed prior adjuvant and/or palliative treatment with tamoxifen; randomly assigned to receive forestane vs. megestrol acetate; Switzerland   177; 83% response rate   QOL   De novo tools   Mail survey   No   Unknown   Day et al., 1999 (318)  Adjuvant therapy   Cohort   Women enrolled in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial   82% response rate   QOL   HRQL survey   Self-administered   No   Unknown   Fairclough et al., 1999 (82)  Adjuvant therapy   RCT   Women with hormone-reecptor-negative, lymph node-positive disease; United States   163; 87% response rate   QOL; quality-adjusted survival   Breast Chemotherapy Questionnaire (BCQ)   Self-administered   Yes   No   Gaston-Johansson et al., 1999 (319)  Adjuvant therapy   Cross-section   Women with stage II, III, or IV disease who were scheduled for autologous bone marrow/peripheral blood stem cell transplant; United States   127   Fatigue; pain; depression   Piper Fatigue Scale; MOS Short-form General Health Survey; Gaston-Johannsson Pain-O-Meter   Self-administered   No   Unknown   Hoerger et al., 1999 (320)  Adjuvant therapy   Costs of care   Women ≥45 y old using health care for cardiovascular disease, osteoporosis, breast cancer, or gynecologic cancers; United States   N/A   Costs; health care use   Data from Healthcare Cost and Utilization Project-3 (HCUP-3); national health care survey; discharge data; cost/charge ratios; Medicare fee schedule   N/A   N/A   N/A   Kurtz et al., 1999 (92)  Adjuvant therapy   Longitudinal cohort   Women >65 y old recruited for on-going study of 6 centers in Michigan; United States   383   QOL; comorbidity   MOS SF-36; Symptom Experience Scale   Unknown   No   Unknown   Macquart-Moulin et al., 1999 (321)  Adjuvant therapy   RCT   Women with <9 involved axillary lymph nodes; France   109; subset of 97 at follow-up   QOL; side effects   EORTC QLQ-C30; de novo tool   Self-administered   Yes   No   McKinna et al., 1999 (322)  Adjuvant therapy   RCT   Women with operable breast cancer and suitable for breast-conserving surgery (Jan. 1984-Dec. 1994) who were recommended a policy of observation to the lymphatic pathways; United Kingdom   291   Cancer-related morbidity   Case record review   N/A   N/A   N/A   Silber et al., 1998 (323)  Adjuvant therapy   CEA   Hypothetical cohort of women receiving chemotherapy; use of G-STF to prevent development of neutropenia; United States   N/A   Costs per LYS   Payor charges; survival with the use of published literature   N/A   N/A   N/A   Van Tiggelen et al., 1999 (324)  Adjuvant therapy   CEA   Comparison of oophorectomy with chemotherapy in premenopausal women; Belgium   N/A   Costs (assume equal effects based on one RCT)   Charges with the use of country-specified data   N/A   N/A   N/A   van Enckevort et al., 1999 (325)  Adjuant therapy   CEA   Women receiving chemotherapy, hormonal treatment, or both; The Netherlands   N/A   QALY; costs, preference/utility   Published studies (Jan 1980-Dec 1997)   N/A   N/A   N/A   Joly et al., 2000 (209)  Adjuvant therapy   RCT   Premenopausal women enrolled in a trial testing the efficacy of adjuvant CMF chemotherapy; lymph node negative; France   179; 68% response rate   QOL   EORTC QLQ-C30; EORTC QLQ-BR23   Mail survey   Yes   Unknown   Kramer et al., 2000 (326)  Adjuvant therapy   RCT   Women with baseline QL data from a trial of paclitaxel vs. doxorubicin as first-line chemotherapy; The Netherlands and Belgium   294; 64% response rate   QOL; survival effectiveness   EORTC QLQ-C30; RSCL   Self-administered   No   Unknown   Norum, 2000 (327)  Adjuvant therapy   CEA   Treatment with CMF; Norway   778 articles   QOL; preferences/utility; costs   MEDLINE English language literature with incorporated Norwegian Standard Act practice and cost data   N/A   N/A   N/A   Pandya et al., 2000 (328)  Adjuvant therapy   RCT   Postmenopausal patients experiencing at least one tamoxifen-induced hot flash per day; United States   194   QOL   Diary; de novo tools   Mail survey   No   No   Vrieling et al., 2000 (329)  Adjuvant therapy   RCT   Subset of women entered in the EORTC “boost vs. no-boost” trial of tumorectomy axillary dissection   1872   Cosmetic results   De novo tools   In-person interview   No   Unknown   View Large Appendix Table 6. Characteristics of studies of treatment of metastatic disease: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ABMT = autologous bone marrow transplantation; BMT = bone marrow transplant; CEA = cost-effectiveness analysis; CMF = combination chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil; ECOG = Eastern Cooperative Oncology Group; FAC = combination chemotherapy with 5-fluorouracil, doxorubicin, and cyclophosphamide; LYS = life years saved; MDs = medical doctors; N/A = not applicable; QALY = quality-adjusted life years; RCT = randomized controlled trial; RT = radiation therapy; SWOG = Southwest Oncology Group.   † SeeTable 3 for definitions of abbreviations of measures.   Biermann et al., 1991 (330)  Treatment of metastatic disease   Costs of care   Women with bone metastases; United States   457   LOS; costs per fracture; per hypercalcemia episode; per pain control; functioning   Hospital costs for fracture; OPD costs for RT and other care; chart note of inability to perform activities; chart review   N/A   N/A   N/A   van Holten-Verzantyoort et al., 1991 (210)  Treatment of metastatic disease   RCT   Women with osteolytic metastases with a life expectancy >6 mo; randomly assigned to receive supportive pamidronate treatment; The Netherlands   1179; 96% response rate   QOL   De novo tools   Mail survey and in-person interview   Yes   Unknown   Hillner et al., 1992 (331)  Treatment of metastatic disease   CEA   Hypothetical cohorts of women with metastatic disease treated with ABMT vs. standard chemotherapy; United States   N/A   Costs per LYS   Costs at one institution and Medicare costs; survival with the use of published literature   N/A   N/A   N/A   Koopmanschap et al., 1992 (332)  Treatment of metastatic disease   Costs of care   Care of women with advanced cancer over the course of disease; The Netherlands   N/A   Costs of advanced care; costs of home care; patient time costs; caregiver time costs   Costs of home care, hospital costs, nursing home costs   N/A   N/A   N/A   Kornblith et al., 1993 (333)  Treatment of metastatic disease   RCT   Women with stage IV cancer receiving megestrol acetate in 2 doses; average age 61 y; 88% white; United States   131   QOL   FLIC: MOS SF-36 and MHI; Body Image Subscale of Sexual Functioning Inventory; de novo side-effect index LRS   Mail survey; telephone interview   No   Unknown   Peters et al., 1994 (334)  Treatment of metastatic disease   Costs of care   Women undergoing high-dose chemotherapy with BMT and PBBCs; United States   110   Costs of episode of care   Hospital charges   N/A   N/A   N/A   Bertsch and Donaldson, 1995 (221)  Treatment of metastatic disease   RCT   Women with refractory advanced disease receiving either vinorelbine or melphalan; United States   179; Differential losses to follow-up; not analyzed by intention   QOL   Modified SWOG QOL; MOS SF-36; SDS; LRS   In-person interview   No   Unknown   Hayes et al., 1995 (335)  Treatment of metastatic   RCT   Women with metastatic disease randomly assigned to receive tamoxifen vs. toremifene in 2 doses; United States   648   QOL; symptoms   LRS; ECOG Analgesics Requirement Scale; pain assessment; ECOG Performance Status   Unknown   No   Unknown   Jones et al., 1995 (72)  Treatment of metastatic disease   RCT   Women with refractory advanced disease; median age 53 y (range, 29-83 y); 12% black; United States   183   QOL   Modified SWOG QOL   Self-administered   No   Unknown   McQuellon et al., 1995 (336)  Treatment of metastatic disease   Cross-section   Women with early-stage disease queried about preferences for treatment of metastatic cancer   15   Preferences   Modified TTO   In-person interview   No   Unknown   Hultborn et al., 1996 (337)  Treatment of metastatic disease   RCT (crossover at progression)   Women receiving methoxyprogesterone vs. aminoglutethimide plus cortisone; Sweden   200   QOL   NHP   Unknown   No   Unknown   Hultborn et al., 1996 (338)  Treatment of metastatic disease   RCT   Women with skeletal metastases; pamidronate vs. placebo; Sweden   404   Skeletal pain; performance status   VAS; performance status   Unknown   No   Unknown   Jonat et al., 1996 (339)  Treatment of metastatic disease   RCT   Postmenopausal women randomly assigned to receive arimidex or megase; Europe   378   QOL   RSCL; performance status   Self-administered   No   No   Launois et al., 1996 (340)  Treatment of metastatic disease   CEA using local data   Docetaxel vs. palitaxel vs. vinorelbine; France   N/A   Costs per Qaly   Direct costs in NHP; survival; utilities; utilities based on opinion of 20 nurses   Not stated   N/A   N/A   van Holten-Verzantvoort et al., 1996 341)  Treatment of metastatic disease   RCT   Women with skeletal metastases; pamidronate vs. placebo; The Netherlands   124   Skeletal pain; symptoms; mobility impairment   De novo tool   Self-administered   No   Unknown   Bates et al., 1997 (342)  Treatment of metastatic disease   CEA   Women with stage IIIB or IV disease receiving FAC and dexrazoxane (administered after 6 courses of FAC) vs. FAC alone; United States   N/A   Cost per cardiac event prevented; costs per LYS (note: costs of recurrence or any downstream events not included)   Medication costs and costs of cardiac events; survival with the use of data from 2 RCTs and expert opinion   N/A   N/A   N/A   Ramirez et al., 1998 (61)  Treatment of metastatic disease   Longitudinal cohort   Women with advanced metastatic disease receiving palliative chemotherapy; median age 58 y (range, 30-80 y); England   155; >90% response rate   QOL   RSCL; de novo items on overall well-being and perceived benefit of treatment   Interviewer administered   No   Unknown   Joensuu et al., 1998 (343)  Treatment of metastatic disease   RCT   Women <70 y old (average age 55 y) with metastases receiving epirubicin followed by mitomycin vs. CEF followed by VM; Finland   285   QOL   RSCL   Unknown   Yes   Unknown   Brown and Hutton, 1998 (344)  Treatment of metastatic disease   CEA   Docetaxel vs. paclitaxel for patients with advanced metastatic disease; England   N/A   Costs; QALYs   Direct costs estimated by MDs and Medicare; nurse-assessed utility; data from published literature   N/A   N/A   N/A   Bull et al., 1991 (222)  Treatment of recurrence   Longitudinal cohort within RCT   Women with recurrent disease; <70 y old; stages I-III; Italy   1320; subset of 176 with recurrence   QOL; satisfaction; symptoms   25 items used in Italian for 6 domains; LRS for satisfaction; symptom checklist   Mail survey   No   Unknown   Cobleigh et al., 1999 (345)  Treatment of metastatic disease   RCT   Women with HER2-over-expressing disease after one or two chemotherapy treatments; United States, Canada, Belguim, France, Germany, United Kingdom, and Australia   222; subset of 154 assessed for QOL   QOL   EORTC QLQ-C30   In-person interview   No   Unknown   Cotton et al., 1999 (346)  Treatment of metastatic disease   RCT   Women diagnosed with invasive disease within the last 18 mo or recurrence who were participating in a larger study designed to compare the efficacy of two psychosocial support programs; United States   142   Spiritual well-being; QOL; psychologic adjustment   FACIT-B; FACTSP; Mini-Mental Adjustment to Cancer; Principles of Living Survey   Self-administered   No   Unknown   Harper-Wynne et al., 1999 (208)  Treatment of metastatic disease   RCT   Women with locally advanced or metastatic disease; concluded adjuvant therapy at least 2 y before; randomly assigned to receive CMF vs. MM; England   116   QOL; satisfaction; symptoms   HADS; RSCL; patient satisfaction questions   In-person interview   No   Noted to be low   Hoerger et al., 1999 (320)  Treatment of metastatic disease   Costs of care   Women ≥45 y old using health care for cardiovascular disease, osteoporosis, breast cancer, or gynecologic cancers; United States   N/A   Costs; health care use   Data from Health care Cost and Utilization Project-3 (HCUP-3); national health care survey; discharge data—cost/charge ratios; Medicare fee schedule   N/A   N/A   N/A   Hultborn et al., 1999 (347)  Treatment of metastatic disease   RCT   Women with skeletal metastases not previously treated with bisphosphates randomly assigned to receive pamidronate vs. placebo; Sweden and Norway   404   Pain; skeletal-related events   Visual Analogue Scales; analgesic consumption   In-person interview   No   Unknown   Kristensen et al. 1999 (348)  Treatment of metastatic disease   RCT   Women who received first-line systemic antineoplastic disease vs. placebo; bone involvement for <6 mo or untreated; Denmark   100   QOL   EORTC QLQ-C30; HADS   In-person interview   No   Unknown   Leung et al., 1999 (349)  Treatment of metastatic disease   CEA   Women who are anthracycline resistant who had received paclitaxel, docetaxel, or vinorelbine during the past ≥2 y   Unknown   Preferences/utility; cost per quality-adjusted progression-free year   Chart review   N/A   N/A   N/A   Nabholtz et al., 1999 (350), 1997 (351)  Treatment of metastatic disease   RCT   Women ≥ 18 y old with progressive metastatic disease; randomly assigned to receive docetaxel or mitomycin and vinblastine; Canada and Europe   392   QOL (global and physical functions)   EORTC-QLQ-C30   Self-administered   No   Unknown   Nuijten et al., 1999 (352)  Treatment of metastatic disease   CEA   Hypothetical cohort of postmenopausal women recruited for the AR/BC2 clinical trial treated with letrozole; United Kingdom   N/A   Preference/utility; costs   Based on clinical trial results showing the advantage of letrozole in terms of time to disease progression and duration of response   N/A   N/A   N/A   Osoba and Burchmore, 1999 (353)  Treatment of metastatic disease   RCT   Women with progressive HER2-overexpressing metastatic disease treated with Trasuzumab vs. placebo; Canada   222 for phase II and 469 for phase III   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Burgess et al., 2000 (354)  Treatment of metastatic disease   RCT   Women who had detected disease symptoms themselves; interviewed 5 mo after diagnosis; United Kingdom   196   Presence of adverse life events and difficulties; psychiatric morbidity   LEDS; SCID; DSM III-R diagnostic criteria   In-person interview   No   Unknown   Geels et al., 2000 (355)  Treatment of metastatic disease   Cohort   Women with metastatic disease; randomly assigned to receive intravenous doxorubicin or doxorubicin with vinorelbine; Canada   300; 96% response rate   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Hakamies-Blomqvist et al., 2000 (356)  Treatment of metastatic disease   RCT   Women with metastatic disease; randomly assigned to receive docetaxel vs. sequential methotrexate and 5-fluorouracil (Dec. 1994 to Oct. 1997); Scandinavia   283   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Hillner et al., 2000 (357)  Treatment of metastatic disease   CEA   Hypothetical group of women with osteolytic bone metastases receiving pamidronate; United States   N/A   Preference/utility; costs   Database of costs at the Massey Cancer Center; based on Aredia Breast Cancer Study Group trials   N/A   N/A   N/A   Kaufmann et al., 2000 (358)  Treatment of metastatic disease   RCT   Postmenopausal women with disease progression/relapse during TAM treatment and at least one lytic bony lesion; randomly assigned to receive exemestane vs. megestrol acetate; 19 countries   769   QOL; tolerability   Unknown   Self-administered   No   Unknown   Kramer et al., 2000 (359)  Treatment of metastatic disease   RCT   Women with metastatic disease; randomly assigned to receive paclitaxel vs. doxorubicin as first-line chemotherapy; The Netherlands, Denmark, and Belgium   294; subset of 187 (64%) for QOL analysis   QOL   EORTC QLQ-C30; RSCL   Self-administered   No   Unknown   Lipton et al., 2000 (360)  Treatment of metastatic disease   RCT   Women with osteolytic bone metastases receiving pamidronate; United States, Canada, Australia, and New Zealand   754   Skeletal complications   Biological markers   N/A   No   Unknown   Norris et al., 2000 (361)  Treatment of metastatic disease   RCT   National Cancer Institute of Canada Clinical Trials Group Study MA8; patients 18-75 y old; life expectancy >16 wk; randomly assigned to receive vinorelbine and doxorubicin vs. doxorubicin; Canada   303   QOL   EORTC QLQ-C30; de novo tool   In-person interview   No   Unknown   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ABMT = autologous bone marrow transplantation; BMT = bone marrow transplant; CEA = cost-effectiveness analysis; CMF = combination chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil; ECOG = Eastern Cooperative Oncology Group; FAC = combination chemotherapy with 5-fluorouracil, doxorubicin, and cyclophosphamide; LYS = life years saved; MDs = medical doctors; N/A = not applicable; QALY = quality-adjusted life years; RCT = randomized controlled trial; RT = radiation therapy; SWOG = Southwest Oncology Group.   † SeeTable 3 for definitions of abbreviations of measures.   Biermann et al., 1991 (330)  Treatment of metastatic disease   Costs of care   Women with bone metastases; United States   457   LOS; costs per fracture; per hypercalcemia episode; per pain control; functioning   Hospital costs for fracture; OPD costs for RT and other care; chart note of inability to perform activities; chart review   N/A   N/A   N/A   van Holten-Verzantyoort et al., 1991 (210)  Treatment of metastatic disease   RCT   Women with osteolytic metastases with a life expectancy >6 mo; randomly assigned to receive supportive pamidronate treatment; The Netherlands   1179; 96% response rate   QOL   De novo tools   Mail survey and in-person interview   Yes   Unknown   Hillner et al., 1992 (331)  Treatment of metastatic disease   CEA   Hypothetical cohorts of women with metastatic disease treated with ABMT vs. standard chemotherapy; United States   N/A   Costs per LYS   Costs at one institution and Medicare costs; survival with the use of published literature   N/A   N/A   N/A   Koopmanschap et al., 1992 (332)  Treatment of metastatic disease   Costs of care   Care of women with advanced cancer over the course of disease; The Netherlands   N/A   Costs of advanced care; costs of home care; patient time costs; caregiver time costs   Costs of home care, hospital costs, nursing home costs   N/A   N/A   N/A   Kornblith et al., 1993 (333)  Treatment of metastatic disease   RCT   Women with stage IV cancer receiving megestrol acetate in 2 doses; average age 61 y; 88% white; United States   131   QOL   FLIC: MOS SF-36 and MHI; Body Image Subscale of Sexual Functioning Inventory; de novo side-effect index LRS   Mail survey; telephone interview   No   Unknown   Peters et al., 1994 (334)  Treatment of metastatic disease   Costs of care   Women undergoing high-dose chemotherapy with BMT and PBBCs; United States   110   Costs of episode of care   Hospital charges   N/A   N/A   N/A   Bertsch and Donaldson, 1995 (221)  Treatment of metastatic disease   RCT   Women with refractory advanced disease receiving either vinorelbine or melphalan; United States   179; Differential losses to follow-up; not analyzed by intention   QOL   Modified SWOG QOL; MOS SF-36; SDS; LRS   In-person interview   No   Unknown   Hayes et al., 1995 (335)  Treatment of metastatic   RCT   Women with metastatic disease randomly assigned to receive tamoxifen vs. toremifene in 2 doses; United States   648   QOL; symptoms   LRS; ECOG Analgesics Requirement Scale; pain assessment; ECOG Performance Status   Unknown   No   Unknown   Jones et al., 1995 (72)  Treatment of metastatic disease   RCT   Women with refractory advanced disease; median age 53 y (range, 29-83 y); 12% black; United States   183   QOL   Modified SWOG QOL   Self-administered   No   Unknown   McQuellon et al., 1995 (336)  Treatment of metastatic disease   Cross-section   Women with early-stage disease queried about preferences for treatment of metastatic cancer   15   Preferences   Modified TTO   In-person interview   No   Unknown   Hultborn et al., 1996 (337)  Treatment of metastatic disease   RCT (crossover at progression)   Women receiving methoxyprogesterone vs. aminoglutethimide plus cortisone; Sweden   200   QOL   NHP   Unknown   No   Unknown   Hultborn et al., 1996 (338)  Treatment of metastatic disease   RCT   Women with skeletal metastases; pamidronate vs. placebo; Sweden   404   Skeletal pain; performance status   VAS; performance status   Unknown   No   Unknown   Jonat et al., 1996 (339)  Treatment of metastatic disease   RCT   Postmenopausal women randomly assigned to receive arimidex or megase; Europe   378   QOL   RSCL; performance status   Self-administered   No   No   Launois et al., 1996 (340)  Treatment of metastatic disease   CEA using local data   Docetaxel vs. palitaxel vs. vinorelbine; France   N/A   Costs per Qaly   Direct costs in NHP; survival; utilities; utilities based on opinion of 20 nurses   Not stated   N/A   N/A   van Holten-Verzantvoort et al., 1996 341)  Treatment of metastatic disease   RCT   Women with skeletal metastases; pamidronate vs. placebo; The Netherlands   124   Skeletal pain; symptoms; mobility impairment   De novo tool   Self-administered   No   Unknown   Bates et al., 1997 (342)  Treatment of metastatic disease   CEA   Women with stage IIIB or IV disease receiving FAC and dexrazoxane (administered after 6 courses of FAC) vs. FAC alone; United States   N/A   Cost per cardiac event prevented; costs per LYS (note: costs of recurrence or any downstream events not included)   Medication costs and costs of cardiac events; survival with the use of data from 2 RCTs and expert opinion   N/A   N/A   N/A   Ramirez et al., 1998 (61)  Treatment of metastatic disease   Longitudinal cohort   Women with advanced metastatic disease receiving palliative chemotherapy; median age 58 y (range, 30-80 y); England   155; >90% response rate   QOL   RSCL; de novo items on overall well-being and perceived benefit of treatment   Interviewer administered   No   Unknown   Joensuu et al., 1998 (343)  Treatment of metastatic disease   RCT   Women <70 y old (average age 55 y) with metastases receiving epirubicin followed by mitomycin vs. CEF followed by VM; Finland   285   QOL   RSCL   Unknown   Yes   Unknown   Brown and Hutton, 1998 (344)  Treatment of metastatic disease   CEA   Docetaxel vs. paclitaxel for patients with advanced metastatic disease; England   N/A   Costs; QALYs   Direct costs estimated by MDs and Medicare; nurse-assessed utility; data from published literature   N/A   N/A   N/A   Bull et al., 1991 (222)  Treatment of recurrence   Longitudinal cohort within RCT   Women with recurrent disease; <70 y old; stages I-III; Italy   1320; subset of 176 with recurrence   QOL; satisfaction; symptoms   25 items used in Italian for 6 domains; LRS for satisfaction; symptom checklist   Mail survey   No   Unknown   Cobleigh et al., 1999 (345)  Treatment of metastatic disease   RCT   Women with HER2-over-expressing disease after one or two chemotherapy treatments; United States, Canada, Belguim, France, Germany, United Kingdom, and Australia   222; subset of 154 assessed for QOL   QOL   EORTC QLQ-C30   In-person interview   No   Unknown   Cotton et al., 1999 (346)  Treatment of metastatic disease   RCT   Women diagnosed with invasive disease within the last 18 mo or recurrence who were participating in a larger study designed to compare the efficacy of two psychosocial support programs; United States   142   Spiritual well-being; QOL; psychologic adjustment   FACIT-B; FACTSP; Mini-Mental Adjustment to Cancer; Principles of Living Survey   Self-administered   No   Unknown   Harper-Wynne et al., 1999 (208)  Treatment of metastatic disease   RCT   Women with locally advanced or metastatic disease; concluded adjuvant therapy at least 2 y before; randomly assigned to receive CMF vs. MM; England   116   QOL; satisfaction; symptoms   HADS; RSCL; patient satisfaction questions   In-person interview   No   Noted to be low   Hoerger et al., 1999 (320)  Treatment of metastatic disease   Costs of care   Women ≥45 y old using health care for cardiovascular disease, osteoporosis, breast cancer, or gynecologic cancers; United States   N/A   Costs; health care use   Data from Health care Cost and Utilization Project-3 (HCUP-3); national health care survey; discharge data—cost/charge ratios; Medicare fee schedule   N/A   N/A   N/A   Hultborn et al., 1999 (347)  Treatment of metastatic disease   RCT   Women with skeletal metastases not previously treated with bisphosphates randomly assigned to receive pamidronate vs. placebo; Sweden and Norway   404   Pain; skeletal-related events   Visual Analogue Scales; analgesic consumption   In-person interview   No   Unknown   Kristensen et al. 1999 (348)  Treatment of metastatic disease   RCT   Women who received first-line systemic antineoplastic disease vs. placebo; bone involvement for <6 mo or untreated; Denmark   100   QOL   EORTC QLQ-C30; HADS   In-person interview   No   Unknown   Leung et al., 1999 (349)  Treatment of metastatic disease   CEA   Women who are anthracycline resistant who had received paclitaxel, docetaxel, or vinorelbine during the past ≥2 y   Unknown   Preferences/utility; cost per quality-adjusted progression-free year   Chart review   N/A   N/A   N/A   Nabholtz et al., 1999 (350), 1997 (351)  Treatment of metastatic disease   RCT   Women ≥ 18 y old with progressive metastatic disease; randomly assigned to receive docetaxel or mitomycin and vinblastine; Canada and Europe   392   QOL (global and physical functions)   EORTC-QLQ-C30   Self-administered   No   Unknown   Nuijten et al., 1999 (352)  Treatment of metastatic disease   CEA   Hypothetical cohort of postmenopausal women recruited for the AR/BC2 clinical trial treated with letrozole; United Kingdom   N/A   Preference/utility; costs   Based on clinical trial results showing the advantage of letrozole in terms of time to disease progression and duration of response   N/A   N/A   N/A   Osoba and Burchmore, 1999 (353)  Treatment of metastatic disease   RCT   Women with progressive HER2-overexpressing metastatic disease treated with Trasuzumab vs. placebo; Canada   222 for phase II and 469 for phase III   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Burgess et al., 2000 (354)  Treatment of metastatic disease   RCT   Women who had detected disease symptoms themselves; interviewed 5 mo after diagnosis; United Kingdom   196   Presence of adverse life events and difficulties; psychiatric morbidity   LEDS; SCID; DSM III-R diagnostic criteria   In-person interview   No   Unknown   Geels et al., 2000 (355)  Treatment of metastatic disease   Cohort   Women with metastatic disease; randomly assigned to receive intravenous doxorubicin or doxorubicin with vinorelbine; Canada   300; 96% response rate   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Hakamies-Blomqvist et al., 2000 (356)  Treatment of metastatic disease   RCT   Women with metastatic disease; randomly assigned to receive docetaxel vs. sequential methotrexate and 5-fluorouracil (Dec. 1994 to Oct. 1997); Scandinavia   283   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Hillner et al., 2000 (357)  Treatment of metastatic disease   CEA   Hypothetical group of women with osteolytic bone metastases receiving pamidronate; United States   N/A   Preference/utility; costs   Database of costs at the Massey Cancer Center; based on Aredia Breast Cancer Study Group trials   N/A   N/A   N/A   Kaufmann et al., 2000 (358)  Treatment of metastatic disease   RCT   Postmenopausal women with disease progression/relapse during TAM treatment and at least one lytic bony lesion; randomly assigned to receive exemestane vs. megestrol acetate; 19 countries   769   QOL; tolerability   Unknown   Self-administered   No   Unknown   Kramer et al., 2000 (359)  Treatment of metastatic disease   RCT   Women with metastatic disease; randomly assigned to receive paclitaxel vs. doxorubicin as first-line chemotherapy; The Netherlands, Denmark, and Belgium   294; subset of 187 (64%) for QOL analysis   QOL   EORTC QLQ-C30; RSCL   Self-administered   No   Unknown   Lipton et al., 2000 (360)  Treatment of metastatic disease   RCT   Women with osteolytic bone metastases receiving pamidronate; United States, Canada, Australia, and New Zealand   754   Skeletal complications   Biological markers   N/A   No   Unknown   Norris et al., 2000 (361)  Treatment of metastatic disease   RCT   National Cancer Institute of Canada Clinical Trials Group Study MA8; patients 18-75 y old; life expectancy >16 wk; randomly assigned to receive vinorelbine and doxorubicin vs. doxorubicin; Canada   303   QOL   EORTC QLQ-C30; de novo tool   In-person interview   No   Unknown   View Large Appendix Table 7. Characteristics of studies on the outcomes of breast cancer survivors: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ADLs = activities of daily living; BCS = breast conserving surgery; FDA = Food and Drug Administration; MD = medical doctor; N/A = not available; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy; SEER = Surveillance, Epidemiology, and End Results.   † SeeTable 3 for definitions of abbreviations of measures.   Marks et al., 1990 (65)  Survivor   Longitudinal cohort   Women with local- and regional-stage disease; mean age 59 y (range, 40-84 y); 1 y after treatment; population-based registry; 15% black; United States   274; 77% response rate   Effect of health on functioning; perceived stress; uncertainty and control; mental health; sexual function; comorbidity symptoms   De novo tools; HSCL; Andrews and Withey QOL; Caplan Role and Emotional Function; Bradburn's Positive Affect Scale; Rosenberg's Scale of Self-Esteem; Berkman's Social Network Index; House Social Support   Self- and interviewer administered   Yes   Unknown   Levy et al., 1992 (220)  Survivor   Longitudinal cohort   Women undergoing MST or BCS; assessed 3 and 15 mo after surgery; average age 51 y; United States   129; 95% response rate but approximately 50% lost to follow-up   QOL   POMS; KPS; MPSSQ   Unknown   No   Unknown   Hannisdal et al., 1993 (362)  Survivor   Costs of care   Cohort of women treated for stage I or II disease followed-up for 8 y; Norway   430   Costs of follow-up per detected relapse; survival   Costs; relapse rates; survival   N/A   N/A   N/A   Holli and Hakama, 1993 (363)  Survivor   Retrospective cohort   Women diagnosed between 1977 and 1980; residing in one district and reported to national cancer registry; followed for 5 y; disease stage not stated; Finland   551   QOL   Sick leave; KPS; notes on QOL; medical record review   N/A   No   Unknown   Bloom and Kessler, 1994 (62)  Survivor   Longitudinal cohort   Women after surgical treatment for early breast cancer, gallbladder disease, or benign breast disease or no surgery; enrolled in Psychological Aspects of Breast Cancer Study; average age 52.5 y (range, 30-69 y); 9.6% black, 3% Asian, and 3% Hispanic; all English speaking; United States   145   Perceived social support; stigma; role functioning   Perceived Social Support Scale (unpublished tool); Social Role Function and Daily Activities Scale; Family Interaction Scale from SIP; Social Health Index; MOS PF   Self-administered survey; in-person interview; 5-meeting speech sample   No   Unknown   GIVIO, 1994 (364)  Survivor   RCT   Women <70 y old with stage I, II, or III disease, randomly assigned to low- vs. high-intensity follow-up surveillance over 5-6 years; Italy   1320   QOL; satisfaction with care   25 items modified from FLIC, SIP, POMS, and CARES   Self-administered   Yes   Unknown   Mor et al., 1994 (365)  Survivor   Cohort   Women enrolled in two RCTs using similar protocols and measures; aged >24 y; state I and II disease; United States   262   QOL   MHI; Katz ADL and IADL; de novo financial impact   Telephone interview   No   Unknown   Roberts et al., 1994 (211)  Survivor   Cross-section   Women aged 29-82 y 6 mo after surgery; disease stage not stated; United States   100   Patient-MD communication; psychologic distress in 9 domains   CDIS; SCL-90-R; MD-rated health; Northhouse social support   Telephone interview; bias: PI interviewer   Yes   Unknown   Coleman et al., 1995 (366)  Survivor   Cross-section   Women aged 40-69 y with silicone implants reported to FDA as having problems after mastectomies; 97% white; United States   120   ADL; role relations; coping   Open-ended questions   Telephone interviews   N/A   Unknown   Couzi et al., 1995 (63)  Survivor   Cross-section   Postmenopausal women diagnosed with in situ or invasive locoregional breast car cer in the years 1988-1992; mean age 55 y (range, 41-65 y); 14% black; United States   190; 77% response rate   QOL; symptoms   De novo tool   Mail survey   No   Yes   German Breast Cancer Study Group, 1995 (367)  Survivor   Longitudinal cohort   Women with stage I disease receiving MST or BCS plus RT; Germany   1036; QOL available for 703   QOL   Unknown   Self-administered   No   Unknown   Liberati, 1995 (90)  Survivor   RCT   Women treated for stage I, II, or III unilateral primary breast cancer were randomly assigned to intensive surveillance vs. less intensive surveillance; <70 y old; Italy   1320; 639 with 5-y data   Overall QOL; perception of health, emotions, body image, social function, symptoms, satisfaction   De novo tool in Italian   Self-administered   Yes   Yes   Paradiso et al., 1995 (368)  Survivor   Cross-section   Representative sample of specialists, general practitioners, and patients involved in the management of follow-up practice for disease; mean age 58 y (range, 29-83 y); Italy   173; 61% response rate   Emotional response to follow-up; satisfaction   De novo tools   Mail survey   No   N/A   Schover et al., 1995 (215)  Survivor   Cross-section   Women who had partial mastectomy or had immediate breast reconstruction after mastectomy; average age 54 y; mean of 4 y after surgery; United States   218; 44% response rate   QOL and satisfaction   PAIS-SR; BES; Dyadic Adjustment Inventory; Sexual History Form   Mail survey   No   Unknown   Tasmuth et al., 1995 (369)  Survivor   Cross-section   Women who had undergone MRM or BCT; 4-7 y after surgery; ages 29-93 y; Finland   467; 92% response rate   Chronic pain   McGill; LRS   Mail survey   No   Unknown   Dow et al., 1996 (216)  Survivor   Cross-section   Women who are disease free; members of the National Coalition for Cancer Survivorship; mean age 50.9 y (range, 27-77 y); 93% white; United States   294; 43% response rate   QOL   FACT-G; QOL-CS   Mail survey   No   Unknown   Ganz et al., 1996 (85)  Survivor   Cohort   Women who had been interviewed during the 1st year after primary treatment; follow-up at 2-3 y   227; 77% response rate   QOL; psychosocial concerns   FLIC; CARES; MOS SF-36; GHQ   Mail survey; in-person interview   No   Unknown   Grunfeld et al., 1996 (370)  Survivor   RCT   Women with stage I, II or III disease at diagnosis; followed-up for recurrence at hospital vs. primary care sites; mean age 61 y; England   296; 67% response rate   QOL   MOS SF-36; EORTC-QLQ-C30; HADS   Mail survey   No   Unknown   Satariano and DeLorenze, 1996 (64)  Survivor   Longitudinal cohort   Employed women; 3 mo after being diagnosed; ages 40-84 y; reported to a SEER registry; 16% black; United States   296   Return to work   De novo tools   In-person interview   N/A   Unknown   Grunfeld et al., 1996 (370); Adewuyi-Dalton et al., 1998 (371)  Survivor   Cross-section   Women receiving follow-up care in one arm of RCT (primary care); enrolled in an RCT of primary care follow-up; England   109   Satisfaction   Qualitative interview   In-person interview   N/A   Unknown   Ashbury et al., 1998 (198)  Survivor   Case-control   Women who received services from Reach for Recovery vs. control subjects in other areas; Canada   192; 69% response rate; QOL data for 175/192   QOL; satisfaction   FLIC; FACT; Duke-UNC Functional Social Support Questionnaire; open-ended satisfaction items   Interviewer administered for case subjects; mail for control subjects   Yes   Unknown   Gulliford et al., 1997 (372)  Survivor   RCT   Women at two clinics over a 24-mo period; randomly assigned to conventional schedule of clinic visits vs. visits only after mammography; relapse-free for median of 16 mo after treatment; England   196   QOL; satisfaction; use of telephone call-in line; time and costs of follow-up   Medical Research Council QOL   Mail survey   No   Unknown   Lee, 1997 (199)  Survivor   Cross-section   Women who were up to 14 y after MST; Reach for Recovery volunteers; United States   100; 75% response rate   QOL   Ferrans and Powers QLI   Mail survey   Yes   Unknown   Poulsen et al., 1997 (373)  Survivor   RCT   Women <69 y old receiving MST vs. BCS; Denmark   184; 39.6% response rate   QOL; satisfaction   LRS; STAI   Interviewer administered   No   Unknown   Tate et al., 1997 (374)  Survivor   Cross-section   Women with disabilities and women with breast cancer; United States   216   QOL and life satisfaction   FLIC; FACT; FACT SP; SWLS   Unknown   No   Unknown   Bloom et al., 1998 (68)  Survivor   Cross-section   Women ≤50 y old (range, 21-51 y); 30% black; 6 mo after diagnosis; United States   336   QOL; MD-patient communication; body image   Illness Intrusiveness Scale; Cancer Problem Scale; SDS; Emotional Support Scale; MOS SF-36; Rosenberg's Scale of Self-Esteem   Interviewer administered in patient's home       Carpenter et al., 1998 (375,376)  Survivor   Cross-section   Women who are disease free, >3 mo after treatment; postmenopausal; 58 y (range, 36-83 y); stage 0-III; 96% white; United States   136; 114 postmenopausal   Pain; satisfaction with pain therapy; symptoms (hot flashes) and QOL   Wisconsin Brief Pain Inventory; de novo items; MOS SF12, 3 questions on hot flashes; SF12;   Phone interview   No   Unknown   Curran et al., 1998 (200)  Survivor   RCT   Women aged 23-70 y with stage I or II cancer receiving MRM vs. BCS 2 y after surgery; Europe   278   QOL; satisfaction with cosmetic result; fear of recurrence   Avery QOL   Unknown   Yes   Unknown   Dorval et al., 1998 (202)  Survivor   Longitudinal cohort   Women treated for local and regional disease; 8 y after treatment; Canada   124; 96% response rate   QOL; psychologic distress   PSI; arm problems; hospital stays; LWMAT; LES   Telephone interview   Yes   Unknown   Dorval et al., 1998 (201)  Survivor   Case-Control   Women treated for local and regional disease; 8 y after diagnosis (disease-free or with recurrences); randomly selected community control subjects; Canada   386; 96% response rate in case subjects and 61% response rate in control subjects   QOL   Number of health problems requiring hospitalization; arm problems; de novo functional status; PSI; MOS Social Support Scale; LWMAT; LES   Telephone interview   Yes   Unknown   Ferrell et al., 1998 (218)  Survivor   Cross-section   Women who are disease free; stratified by 3 age groups: <40 y old, 40-60 y old, and >60 y old; United States   298; 40% response rate   QOL; pain   QOL-BC; BPI   Mail survey   No   Unknown   Frazer et al., 1998 (203)  Survivor   Cross-section   Women seen at cancer center; average age 61 y; United States   120; 57% response rate   QOL   HSQ   Mail survey   Yes   Unknwon   Ganz et al., 1998 (67,204)  Survivor   Cross-section   Women who are disease-free; mean age 56 y (range, 31-88 y) with stage 0, I, or II disease surveyed 1-5 y after diagnosis in 2 regions; 11%-17% black per region; 1%-6% Hispanic; United States   864   QOL; sexual function   MOS SF-36; CES-D; BCPT Symptom Checklist; WSFQ; CARES   Mail survey   Yes   Unknown   Jahkola, 1998 (377)  Survivor   Cross-section   Women treated with MST or BCS; 3-8 y after surgery; mean age 60 y (range, 33-84 y); Finland   146   QOL; satisfaction   De novo tool   Mail survey   N/A   N/A   Lindley et al., 1998 (66)  Survivor   Cross-section   Women with early-stage cancer who were disease free 2-5 y after adjuvant treatment; average age 54 y (range, 29-86 y); 87.1% white; United States   120; 86 completed all data   QOL; preferences   FLIC; SDS; MOS SF-36; de novo sexuality; modified TTO preferences   Telephone interview   No   Unknown   Tomiak et al., 1998 (217)  Survivor   Costs of care   Costs of following-up women with stage I or II disease; Canada   130 MDs; 44% response rate   Follow-up costs per patient   Unit costs in the NHP   Mail survey   N/A   N/A   van Harten et al., 1998 (205)  Survivor   Cross-section   Women who were patients of 4 oncologists; The Netherlands   103; 60% response rate   QOL   CARES-SF; RSCL; QLQ; EORTC; comorbidity   Mail survey   Yes   Unknown   Velanovich and Szymanski, 1999 (378)  Survivor   Cross-section   Patients of one MD at a cancer center; >6 mo to 4 y after surgery; United States   101   Lymphedema; QOL   MOS SF-36   Self-administered in MD's office   No   Unknown   Andersen and Urban, 1999 (379)  Survivor   Cross-section   Women who are disease free; 50-85 y old; in rural and suburban communities   292   QOL   MOS SF-36; Lerman Cancer Worry Scale; de novo tool   Telephone interview   No   Unknown   Ashing-Giwa et al., 1999 (70)  Survivor   Cross-section   Women 6-8 y after surgery; age range; 32-90 y; 42% black; United States   278; 54% overall response rate; 44% in blacks; 65% in whites   QOL   MOS SF-36; CARES-SF; Ladder; Urban Life Stress Scale; ADQ   Mail survey   No   Unknown   Carpenter and Andrykowski, 1999 (380)  Survivor   Cross-section   Women who are disease-free; ≥18 y old 3 mo after treatment of 1st diagnosis; United States   114; 79% response rate   QOL; menopausal symptoms   Massachusetts Women's Health Study Questionnaire; Blatt Menopausal Index; SF-12 Health Survey   Telephone interview   Yes   Unknown   Fogarty et al., 1999 (213)  Survivor   RCT   Women diagnosed at least 6 mo before and presently disease-free or without cancer but an average of 3 friends/relatives with history of breast cancer   210   Patient anxiety; physician compassion   STAI; de novo tools   Mail survey   Yes   Unknown   Ganz et al., 1999 (81)  Survivor   Cross-section   Women who were in a partnered relationship and sexually active within the past 6 mo in Los Angeles, CA, and Washington, DC, with a diagnosis of stage, 0, I, or II disease and who completed local and adjuvant therapy; United States   1134   Sexual health   CARES Body Image Subscale; Sexual Functioning Summary Scale, Sexual Interest and Dysfunction Subscale; BCPT Symptom Checklist; Revised DAS; RAND Health Survey; WSFQ   Mail survey   No   Unknown   Grunfeld et al., 1999 (214)  Survivor   RCT   Women who received follow-up care in primary care vs. specialist care; United Kingdom   296   Patient satisfaction   De novo tools   Self-administered   Yes   Unknown   Spenser et al., 1999 (69)  Survivor   Cross-section   Women 1 y after treatment; stage 0, I, or II disease; approximately 10% black and 20% Hispanic; United States   223; 80% response rate   QOL   De novo tool on patient concerns; POMS; CES-D; Andrews and Withey adjustment; PAIS-SR; de novo body image; SIP (English and Spanish translations)   Mail survey   Yes   Unknown   Bower et al., 2000 (381)  Survivor   RCT   Women treated for early resectable disease; not receiving any treatment besides tamoxifen; in 2 large metropolitan areas; United States   1957   QOL; level of fatigue   MOS SF-36; CES-D; BCPT Symptom Checklist; MOS Sleep Scale   Mail survey   No   Unknown   Demark-Wahnefried et al., 2000 (382)  Survivor   Cross-section   Women who were identified by the Duke Cancer Database as being diagnosed with early-stage disease but who are now disease free   1666; 58% response rate   Current health behaviors; readiness to pursue life-style changes   Eating Patterns Questionnaire; de novo tools   Mail survey   No   Unknown   Wilson et al., 2000 (48)  Survivor   Cohort   Women who are disease free; in rural communities; during a 5-mo period in 1996; United States   128   Survivors' representations; positive coping strategies; negative coping strategies   Focus group   In-person interview   No   Unknown   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ADLs = activities of daily living; BCS = breast conserving surgery; FDA = Food and Drug Administration; MD = medical doctor; N/A = not available; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy; SEER = Surveillance, Epidemiology, and End Results.   † SeeTable 3 for definitions of abbreviations of measures.   Marks et al., 1990 (65)  Survivor   Longitudinal cohort   Women with local- and regional-stage disease; mean age 59 y (range, 40-84 y); 1 y after treatment; population-based registry; 15% black; United States   274; 77% response rate   Effect of health on functioning; perceived stress; uncertainty and control; mental health; sexual function; comorbidity symptoms   De novo tools; HSCL; Andrews and Withey QOL; Caplan Role and Emotional Function; Bradburn's Positive Affect Scale; Rosenberg's Scale of Self-Esteem; Berkman's Social Network Index; House Social Support   Self- and interviewer administered   Yes   Unknown   Levy et al., 1992 (220)  Survivor   Longitudinal cohort   Women undergoing MST or BCS; assessed 3 and 15 mo after surgery; average age 51 y; United States   129; 95% response rate but approximately 50% lost to follow-up   QOL   POMS; KPS; MPSSQ   Unknown   No   Unknown   Hannisdal et al., 1993 (362)  Survivor   Costs of care   Cohort of women treated for stage I or II disease followed-up for 8 y; Norway   430   Costs of follow-up per detected relapse; survival   Costs; relapse rates; survival   N/A   N/A   N/A   Holli and Hakama, 1993 (363)  Survivor   Retrospective cohort   Women diagnosed between 1977 and 1980; residing in one district and reported to national cancer registry; followed for 5 y; disease stage not stated; Finland   551   QOL   Sick leave; KPS; notes on QOL; medical record review   N/A   No   Unknown   Bloom and Kessler, 1994 (62)  Survivor   Longitudinal cohort   Women after surgical treatment for early breast cancer, gallbladder disease, or benign breast disease or no surgery; enrolled in Psychological Aspects of Breast Cancer Study; average age 52.5 y (range, 30-69 y); 9.6% black, 3% Asian, and 3% Hispanic; all English speaking; United States   145   Perceived social support; stigma; role functioning   Perceived Social Support Scale (unpublished tool); Social Role Function and Daily Activities Scale; Family Interaction Scale from SIP; Social Health Index; MOS PF   Self-administered survey; in-person interview; 5-meeting speech sample   No   Unknown   GIVIO, 1994 (364)  Survivor   RCT   Women <70 y old with stage I, II, or III disease, randomly assigned to low- vs. high-intensity follow-up surveillance over 5-6 years; Italy   1320   QOL; satisfaction with care   25 items modified from FLIC, SIP, POMS, and CARES   Self-administered   Yes   Unknown   Mor et al., 1994 (365)  Survivor   Cohort   Women enrolled in two RCTs using similar protocols and measures; aged >24 y; state I and II disease; United States   262   QOL   MHI; Katz ADL and IADL; de novo financial impact   Telephone interview   No   Unknown   Roberts et al., 1994 (211)  Survivor   Cross-section   Women aged 29-82 y 6 mo after surgery; disease stage not stated; United States   100   Patient-MD communication; psychologic distress in 9 domains   CDIS; SCL-90-R; MD-rated health; Northhouse social support   Telephone interview; bias: PI interviewer   Yes   Unknown   Coleman et al., 1995 (366)  Survivor   Cross-section   Women aged 40-69 y with silicone implants reported to FDA as having problems after mastectomies; 97% white; United States   120   ADL; role relations; coping   Open-ended questions   Telephone interviews   N/A   Unknown   Couzi et al., 1995 (63)  Survivor   Cross-section   Postmenopausal women diagnosed with in situ or invasive locoregional breast car cer in the years 1988-1992; mean age 55 y (range, 41-65 y); 14% black; United States   190; 77% response rate   QOL; symptoms   De novo tool   Mail survey   No   Yes   German Breast Cancer Study Group, 1995 (367)  Survivor   Longitudinal cohort   Women with stage I disease receiving MST or BCS plus RT; Germany   1036; QOL available for 703   QOL   Unknown   Self-administered   No   Unknown   Liberati, 1995 (90)  Survivor   RCT   Women treated for stage I, II, or III unilateral primary breast cancer were randomly assigned to intensive surveillance vs. less intensive surveillance; <70 y old; Italy   1320; 639 with 5-y data   Overall QOL; perception of health, emotions, body image, social function, symptoms, satisfaction   De novo tool in Italian   Self-administered   Yes   Yes   Paradiso et al., 1995 (368)  Survivor   Cross-section   Representative sample of specialists, general practitioners, and patients involved in the management of follow-up practice for disease; mean age 58 y (range, 29-83 y); Italy   173; 61% response rate   Emotional response to follow-up; satisfaction   De novo tools   Mail survey   No   N/A   Schover et al., 1995 (215)  Survivor   Cross-section   Women who had partial mastectomy or had immediate breast reconstruction after mastectomy; average age 54 y; mean of 4 y after surgery; United States   218; 44% response rate   QOL and satisfaction   PAIS-SR; BES; Dyadic Adjustment Inventory; Sexual History Form   Mail survey   No   Unknown   Tasmuth et al., 1995 (369)  Survivor   Cross-section   Women who had undergone MRM or BCT; 4-7 y after surgery; ages 29-93 y; Finland   467; 92% response rate   Chronic pain   McGill; LRS   Mail survey   No   Unknown   Dow et al., 1996 (216)  Survivor   Cross-section   Women who are disease free; members of the National Coalition for Cancer Survivorship; mean age 50.9 y (range, 27-77 y); 93% white; United States   294; 43% response rate   QOL   FACT-G; QOL-CS   Mail survey   No   Unknown   Ganz et al., 1996 (85)  Survivor   Cohort   Women who had been interviewed during the 1st year after primary treatment; follow-up at 2-3 y   227; 77% response rate   QOL; psychosocial concerns   FLIC; CARES; MOS SF-36; GHQ   Mail survey; in-person interview   No   Unknown   Grunfeld et al., 1996 (370)  Survivor   RCT   Women with stage I, II or III disease at diagnosis; followed-up for recurrence at hospital vs. primary care sites; mean age 61 y; England   296; 67% response rate   QOL   MOS SF-36; EORTC-QLQ-C30; HADS   Mail survey   No   Unknown   Satariano and DeLorenze, 1996 (64)  Survivor   Longitudinal cohort   Employed women; 3 mo after being diagnosed; ages 40-84 y; reported to a SEER registry; 16% black; United States   296   Return to work   De novo tools   In-person interview   N/A   Unknown   Grunfeld et al., 1996 (370); Adewuyi-Dalton et al., 1998 (371)  Survivor   Cross-section   Women receiving follow-up care in one arm of RCT (primary care); enrolled in an RCT of primary care follow-up; England   109   Satisfaction   Qualitative interview   In-person interview   N/A   Unknown   Ashbury et al., 1998 (198)  Survivor   Case-control   Women who received services from Reach for Recovery vs. control subjects in other areas; Canada   192; 69% response rate; QOL data for 175/192   QOL; satisfaction   FLIC; FACT; Duke-UNC Functional Social Support Questionnaire; open-ended satisfaction items   Interviewer administered for case subjects; mail for control subjects   Yes   Unknown   Gulliford et al., 1997 (372)  Survivor   RCT   Women at two clinics over a 24-mo period; randomly assigned to conventional schedule of clinic visits vs. visits only after mammography; relapse-free for median of 16 mo after treatment; England   196   QOL; satisfaction; use of telephone call-in line; time and costs of follow-up   Medical Research Council QOL   Mail survey   No   Unknown   Lee, 1997 (199)  Survivor   Cross-section   Women who were up to 14 y after MST; Reach for Recovery volunteers; United States   100; 75% response rate   QOL   Ferrans and Powers QLI   Mail survey   Yes   Unknown   Poulsen et al., 1997 (373)  Survivor   RCT   Women <69 y old receiving MST vs. BCS; Denmark   184; 39.6% response rate   QOL; satisfaction   LRS; STAI   Interviewer administered   No   Unknown   Tate et al., 1997 (374)  Survivor   Cross-section   Women with disabilities and women with breast cancer; United States   216   QOL and life satisfaction   FLIC; FACT; FACT SP; SWLS   Unknown   No   Unknown   Bloom et al., 1998 (68)  Survivor   Cross-section   Women ≤50 y old (range, 21-51 y); 30% black; 6 mo after diagnosis; United States   336   QOL; MD-patient communication; body image   Illness Intrusiveness Scale; Cancer Problem Scale; SDS; Emotional Support Scale; MOS SF-36; Rosenberg's Scale of Self-Esteem   Interviewer administered in patient's home       Carpenter et al., 1998 (375,376)  Survivor   Cross-section   Women who are disease free, >3 mo after treatment; postmenopausal; 58 y (range, 36-83 y); stage 0-III; 96% white; United States   136; 114 postmenopausal   Pain; satisfaction with pain therapy; symptoms (hot flashes) and QOL   Wisconsin Brief Pain Inventory; de novo items; MOS SF12, 3 questions on hot flashes; SF12;   Phone interview   No   Unknown   Curran et al., 1998 (200)  Survivor   RCT   Women aged 23-70 y with stage I or II cancer receiving MRM vs. BCS 2 y after surgery; Europe   278   QOL; satisfaction with cosmetic result; fear of recurrence   Avery QOL   Unknown   Yes   Unknown   Dorval et al., 1998 (202)  Survivor   Longitudinal cohort   Women treated for local and regional disease; 8 y after treatment; Canada   124; 96% response rate   QOL; psychologic distress   PSI; arm problems; hospital stays; LWMAT; LES   Telephone interview   Yes   Unknown   Dorval et al., 1998 (201)  Survivor   Case-Control   Women treated for local and regional disease; 8 y after diagnosis (disease-free or with recurrences); randomly selected community control subjects; Canada   386; 96% response rate in case subjects and 61% response rate in control subjects   QOL   Number of health problems requiring hospitalization; arm problems; de novo functional status; PSI; MOS Social Support Scale; LWMAT; LES   Telephone interview   Yes   Unknown   Ferrell et al., 1998 (218)  Survivor   Cross-section   Women who are disease free; stratified by 3 age groups: <40 y old, 40-60 y old, and >60 y old; United States   298; 40% response rate   QOL; pain   QOL-BC; BPI   Mail survey   No   Unknown   Frazer et al., 1998 (203)  Survivor   Cross-section   Women seen at cancer center; average age 61 y; United States   120; 57% response rate   QOL   HSQ   Mail survey   Yes   Unknwon   Ganz et al., 1998 (67,204)  Survivor   Cross-section   Women who are disease-free; mean age 56 y (range, 31-88 y) with stage 0, I, or II disease surveyed 1-5 y after diagnosis in 2 regions; 11%-17% black per region; 1%-6% Hispanic; United States   864   QOL; sexual function   MOS SF-36; CES-D; BCPT Symptom Checklist; WSFQ; CARES   Mail survey   Yes   Unknown   Jahkola, 1998 (377)  Survivor   Cross-section   Women treated with MST or BCS; 3-8 y after surgery; mean age 60 y (range, 33-84 y); Finland   146   QOL; satisfaction   De novo tool   Mail survey   N/A   N/A   Lindley et al., 1998 (66)  Survivor   Cross-section   Women with early-stage cancer who were disease free 2-5 y after adjuvant treatment; average age 54 y (range, 29-86 y); 87.1% white; United States   120; 86 completed all data   QOL; preferences   FLIC; SDS; MOS SF-36; de novo sexuality; modified TTO preferences   Telephone interview   No   Unknown   Tomiak et al., 1998 (217)  Survivor   Costs of care   Costs of following-up women with stage I or II disease; Canada   130 MDs; 44% response rate   Follow-up costs per patient   Unit costs in the NHP   Mail survey   N/A   N/A   van Harten et al., 1998 (205)  Survivor   Cross-section   Women who were patients of 4 oncologists; The Netherlands   103; 60% response rate   QOL   CARES-SF; RSCL; QLQ; EORTC; comorbidity   Mail survey   Yes   Unknown   Velanovich and Szymanski, 1999 (378)  Survivor   Cross-section   Patients of one MD at a cancer center; >6 mo to 4 y after surgery; United States   101   Lymphedema; QOL   MOS SF-36   Self-administered in MD's office   No   Unknown   Andersen and Urban, 1999 (379)  Survivor   Cross-section   Women who are disease free; 50-85 y old; in rural and suburban communities   292   QOL   MOS SF-36; Lerman Cancer Worry Scale; de novo tool   Telephone interview   No   Unknown   Ashing-Giwa et al., 1999 (70)  Survivor   Cross-section   Women 6-8 y after surgery; age range; 32-90 y; 42% black; United States   278; 54% overall response rate; 44% in blacks; 65% in whites   QOL   MOS SF-36; CARES-SF; Ladder; Urban Life Stress Scale; ADQ   Mail survey   No   Unknown   Carpenter and Andrykowski, 1999 (380)  Survivor   Cross-section   Women who are disease-free; ≥18 y old 3 mo after treatment of 1st diagnosis; United States   114; 79% response rate   QOL; menopausal symptoms   Massachusetts Women's Health Study Questionnaire; Blatt Menopausal Index; SF-12 Health Survey   Telephone interview   Yes   Unknown   Fogarty et al., 1999 (213)  Survivor   RCT   Women diagnosed at least 6 mo before and presently disease-free or without cancer but an average of 3 friends/relatives with history of breast cancer   210   Patient anxiety; physician compassion   STAI; de novo tools   Mail survey   Yes   Unknown   Ganz et al., 1999 (81)  Survivor   Cross-section   Women who were in a partnered relationship and sexually active within the past 6 mo in Los Angeles, CA, and Washington, DC, with a diagnosis of stage, 0, I, or II disease and who completed local and adjuvant therapy; United States   1134   Sexual health   CARES Body Image Subscale; Sexual Functioning Summary Scale, Sexual Interest and Dysfunction Subscale; BCPT Symptom Checklist; Revised DAS; RAND Health Survey; WSFQ   Mail survey   No   Unknown   Grunfeld et al., 1999 (214)  Survivor   RCT   Women who received follow-up care in primary care vs. specialist care; United Kingdom   296   Patient satisfaction   De novo tools   Self-administered   Yes   Unknown   Spenser et al., 1999 (69)  Survivor   Cross-section   Women 1 y after treatment; stage 0, I, or II disease; approximately 10% black and 20% Hispanic; United States   223; 80% response rate   QOL   De novo tool on patient concerns; POMS; CES-D; Andrews and Withey adjustment; PAIS-SR; de novo body image; SIP (English and Spanish translations)   Mail survey   Yes   Unknown   Bower et al., 2000 (381)  Survivor   RCT   Women treated for early resectable disease; not receiving any treatment besides tamoxifen; in 2 large metropolitan areas; United States   1957   QOL; level of fatigue   MOS SF-36; CES-D; BCPT Symptom Checklist; MOS Sleep Scale   Mail survey   No   Unknown   Demark-Wahnefried et al., 2000 (382)  Survivor   Cross-section   Women who were identified by the Duke Cancer Database as being diagnosed with early-stage disease but who are now disease free   1666; 58% response rate   Current health behaviors; readiness to pursue life-style changes   Eating Patterns Questionnaire; de novo tools   Mail survey   No   Unknown   Wilson et al., 2000 (48)  Survivor   Cohort   Women who are disease free; in rural communities; during a 5-mo period in 1996; United States   128   Survivors' representations; positive coping strategies; negative coping strategies   Focus group   In-person interview   No   Unknown   View Large Although most of the noneconomic studies did use previously validated and reliable measures, only one quarter (n = 37 of 139; 26.6%) reported the reliability and validity of the measure in their patient population; none reported data on reliability in population subgroups (e.g., by age or race). Among the 91 economic studies, only one (196) met current standards for a good quality analysis (e.g., societal perspective, quality-adjusted using population values, discounted, including nonmedical and medical costs, and all relevant downstream costs and effects), although nonstandard approaches may be appropriate in certain circumstances or for specified purposes [e.g., evaluation within a health maintenance organization (197)]. In terms of power, only 21 studies (63,69,90,96,198-214) presented information on their power to detect clinically meaningful differences in noneconomic outcomes. Comorbidity is an important covariate that has the potential to confound outcomes results. However, comorbidity was only specifically measured in four studies—one CEA (76), two cross-sectional studies of breast cancer survivors (65,205), and one cross-sectional study of newly diagnosed breast cancer patients (92). However, results were not clearly controlled for this potential confounder in the cross-sectional studies. Similarly, a woman's baseline level of QOL is one of the strongest predictors of her long-term QOL. In an RCT, women with low and high levels of baseline QOL should be distributed randomly across study arms. In longitudinal follow-up studies, baseline QOL can be controlled for in analyses of outcomes. However, in the 46% of the noneconomic outcomes studies that employed a cross-sectional design, effects of variations in initial status were not accounted for in describing results. Additional sources of bias in interpreting existing outcomes research include low response rates. Low response rates (≤50%) are threats to internal validity (70,73,91,215-218); potential differential nonresponse, such as seen in many RCTs with QOL components [e.g., (219)], or differential losses to follow-up by treatment arm or health status [e.g., (220-222)] or response rates by group [e.g., (70,201,223)] are threats to internal validity of the results. In the metastatic disease phase, there is the further challenge of poor response rates or losses to follow-up because of severe illness or death; use of proxy respondents was not addressed in any of these studies. Finally, none of the studies evaluated whether floor or ceiling effects limited their ability to detect differences in outcome or evaluated the amount of missing data and their impact on results. Discussion At present, outcomes measurement is variable in its approach and application to the spectrum of breast cancer care. This enormous variability is evidenced by our finding that no one instrument was used in more than 10% of the studies. Although the past decade has witnessed a dramatic increase in the volume of research on breast health outcomes, large gaps exist in certain phases of care, types of outcomes, populations, and standards of measurement. For instance, only one study evaluated the quality of the dying experience for breast cancer patients, only 15.9% considered patient satisfaction, and only 4.1% included patient preferences. Only one half of the studies were controlled, and studies of survivors were the least likely to include a controlled design that accounted for baseline differences in health and functioning and other important covariates. At present, the overwhelming majority of research focuses on white, nonelderly populations. In terms of the quality of the research, this overview highlights certain cross-cutting deficiencies—no studies commented on the potential for floor or ceiling effects to influence results, only one CEA would be considered to be adequate by current standards, and, among the noneconomic studies, only four measured comorbidity, 37 tested reliability in their own patient population, and 21 noted whether they had sufficient power to detect clinically meaningful differences in outcome. These types of limitations have been noted in other reviews as well (379). Thus, we recommend that a common set of standards be established for the design and conduct of outcomes studies (Table 5), including development of standard, practical tools to measure the burden of illness (including the number of illnesses, severity, and impact on function). Table 5. Recommendations for improving breast cancer outcomes measurement Area   Recommendation   *MOS SF-36 = Medical Outcomes Study—Short Form 36.   Instruments   Develop a set of reliable, valid “core” instruments that can be used across phases of care; supplement with measures appropriate to each phase of breast cancer care. Selection of candidate instruments should be guided by consideration of patient burden and acceptability, feasibility in nonresearch settings, absence of floor or ceiling effects, applicability to multicultural groups, and sensitivity to change over time. The MOS SF-36* may not be an appropriate instrument for these purposes because of floor and ceiling effects and lack of sensitivity to changes across phases of care.   Methods   Set standards for the design and conduct of outcomes studies, including controlling for baseline characteristics or using a randomized design, a priori calculation of power for clinically meaningful outcomes, assessment of reliability, and use of proxies; apply current (minimum) standards for cost-effectiveness analyses to all economic outcome studies; and develop statistical methods to address losses to follow-up or nonresponse among severely ill patients.   Comorbidity   Develop standard, practical tools to measure burden of comorbidity (including number of illnesses, severity, and impact on function). Include comorbidity as a covariate in outcomes research; consider interactions of cancer and comorbidity in assessing outcomes.   Preferences   There needs to be additional research on practical methods to measure patient preferences; measures need to be transportable into economic analyses that calculate cost per quality-adjusted life-year gained.   Populations   Increase research in minority, multicultural, and elderly populations. Begin to include family and caregiver outcomes.   Setting   There needs to be support and partnerships to facilitate translation of outcomes research from research centers to community practices in diverse settings to understand the true effects of interventions and therapies on population-based health outcomes.   Phases of care   There should be attention to all phases of care, particularly the dying experience, primary prevention, diagnosis, adjuvant therapy, and treatment of metastatic disease. Any new survivor studies should be carefully controlled.   Outcomes   There should be an emphasis on increasing the number of studies focusing on satisfaction and patient preferences. Outcomes measuring the quality of the dying experience need to be developed, validated, and applied to breast cancer populations.   Finding   Increase funding for outcomes research especially in vulnerable populations; support the development of an infrastructure for routine outcomes data collection.   Area   Recommendation   *MOS SF-36 = Medical Outcomes Study—Short Form 36.   Instruments   Develop a set of reliable, valid “core” instruments that can be used across phases of care; supplement with measures appropriate to each phase of breast cancer care. Selection of candidate instruments should be guided by consideration of patient burden and acceptability, feasibility in nonresearch settings, absence of floor or ceiling effects, applicability to multicultural groups, and sensitivity to change over time. The MOS SF-36* may not be an appropriate instrument for these purposes because of floor and ceiling effects and lack of sensitivity to changes across phases of care.   Methods   Set standards for the design and conduct of outcomes studies, including controlling for baseline characteristics or using a randomized design, a priori calculation of power for clinically meaningful outcomes, assessment of reliability, and use of proxies; apply current (minimum) standards for cost-effectiveness analyses to all economic outcome studies; and develop statistical methods to address losses to follow-up or nonresponse among severely ill patients.   Comorbidity   Develop standard, practical tools to measure burden of comorbidity (including number of illnesses, severity, and impact on function). Include comorbidity as a covariate in outcomes research; consider interactions of cancer and comorbidity in assessing outcomes.   Preferences   There needs to be additional research on practical methods to measure patient preferences; measures need to be transportable into economic analyses that calculate cost per quality-adjusted life-year gained.   Populations   Increase research in minority, multicultural, and elderly populations. Begin to include family and caregiver outcomes.   Setting   There needs to be support and partnerships to facilitate translation of outcomes research from research centers to community practices in diverse settings to understand the true effects of interventions and therapies on population-based health outcomes.   Phases of care   There should be attention to all phases of care, particularly the dying experience, primary prevention, diagnosis, adjuvant therapy, and treatment of metastatic disease. Any new survivor studies should be carefully controlled.   Outcomes   There should be an emphasis on increasing the number of studies focusing on satisfaction and patient preferences. Outcomes measuring the quality of the dying experience need to be developed, validated, and applied to breast cancer populations.   Finding   Increase funding for outcomes research especially in vulnerable populations; support the development of an infrastructure for routine outcomes data collection.   View Large Given the complexity of breast cancer care and the heterogeneity in patient populations, no one instrument is sufficiently comprehensive, is sensitive to clinically meaningful changes in outcomes across all phases of care, and has acceptable respondent and provider burden. However, it should be possible to develop a “core” set of measures for measuring breast cancer outcomes that can be supplemented by sensitive phase-specific tools. Other issues, such as standardizing the optimal timing of measurement within and across phases, were beyond the scope of this review and are important to address in future research. Finally, it will be important to examine whether conclusions about outcomes are affected by choice of instrument. Our review also highlights the paucity of patient preference data. We suggest that additional research be conducted to develop practical methods to measure patient preferences and that these measures be transportable into economic analyses that calculate cost per quality-adjusted life-year gained. More work is also necessary to understand the quality of the dying experience from both the patient's and the caregiver's perspectives. In summary, more research is needed to develop standard approaches that are 1) practical in a variety of health care settings, 2) reliable and valid, 3) applicable to broad age and race groups and culturally diverse populations, 4) useful to track changes in outcomes as individuals move through the phases of cancer care, and 5) informative for designing interventions to improve the quality of breast cancer services across the entire spectrum of care. Partnerships to facilitate translation of outcomes research from research centers to diverse community practices will be essential for reaching these goals. Supported in part by Public Health Service (PHS) grants HS08395 from the Agency for Health Care Policy and Research, Office of the Assistant Secretary for Health, Department of Health and Human Services (DHHS) (J. Mandelblatt); by grant DAMD17-94-J-4212 from the Department of the Army, Breast Cancer Center Grant (J. Mandelblatt, W. Liang, and W. 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Descriptive Review of the Literature on Breast Cancer Outcomes: 1990 Through 2000

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References (370)

Publisher
Oxford University Press
Copyright
© Oxford University Press
ISSN
1052-6773
eISSN
1745-6614
DOI
10.1093/jncimonographs/lgh003
pmid
15504918
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Abstract

Abstract Background: There is increasing interest in the incorporation of nonbiomedical outcomes into cancer research. Objective: Our goal was to review the use of nonbiomedical outcomes in research on breast cancer care. Data sources: We conducted a MEDLINE search of all studies on breast cancer quality of life, preferences, satisfaction, and economics that were published during the period from January 1, 1990, through December 31, 2000. We also searched bibliographies of published articles. Study selection: We included original primary research and excluded reviews, methods papers, studies conducted outside the United States and Western Europe, or studies with fewer than 100 subjects. Data abstraction: Data were abstracted by using a structured tool. Data synthesis: There were 1089 articles identified; 230 were included. The greatest proportion of research focused on survivorship followed by screening. The most frequently reported outcomes were health-related quality of life (54%) followed by economic analyses (38%) and patient satisfaction (14%); only 9% measured patient preferences. Few studies included more than 10% nonwhite populations or focused on the elderly. No single instrument was used in more than 10% of the studies, and many authors developed de novo tools for use in their study. Methodologic flaws were prevalent and included use of nonstandard economic methods, insufficient power, low or differential response rates, and lack of control for baseline status. Conclusion: At present, outcomes measurement is variable in its approach and application to breast cancer care. More research is needed to develop practical approaches that are reliable, valid, and feasible in routine practice, that are applicable to diverse populations, and that can inform interventions to improve the quality of care across the full spectrum of services. The most general health outcome measure is survival. For breast and other cancers, 5-year survival or the interval of disease-free survival has customarily been used to evaluate the success of treatment. Clinical events, such as severity of illness, tumor response, or stage shifts, have served as intermediate measures of outcome, principally because they are believed to be associated with differences in survival. For many diseases, such as advanced breast cancer, curative treatment is not always possible. Still, the outcomes of noncurative care may be very different. For instance, therapeutic strategies may be associated with similar survival but different toxic effects; alternatively, one therapy may yield better survival but more severe side effects, while another may offer poorer survival but better quality of life (QOL) during the patient's remaining months or years. Thus, decisions about alternative therapies are often based on QOL considerations, in addition to the likelihood of survival (1,2). Even when cures are possible, the costs of treatment may exceed an individual's or society's willingness to pay. Although QOL has been an implied medical outcome since the time of Hippocrates (3,4), the landmark paper by Karnofsky et al. (5) marked the first explicit effort of physicians to systematically assess the impact of cancer treatments on the patient's QOL and not quantity of life. The next major tools developed to assess the impact of cancer and breast cancer therapy on QOL were not developed until the early 1980s. In the prototype, the Spitzer Quality of Life Index, QOL continued to be physician rated (6). Thus, physician assessment of symptoms, toxic effects, and/or QOL remained the standard in breast cancer outcomes research for almost four decades. Increasing consumerism and patient participation in health care decisions, occurring in parallel with the growth in interest in outcomes of care in the late 1970s and the 1980s, set the stage for the development of patient-based measures of general and breast cancer-related QOL (4,7). For example, in 1979, Ware et al. (8) presented results validating a patient's self-reported measure of general health status from the Rand Health Insurance Experiment. Preliminary incorporation of such measures into cancer cooperative group randomized controlled trials (RCTs) occurred in the late 1980s (4,9). Despite the recent explosion of QOL measures, particularly for breast cancer, routine incorporation of QOL outcomes into cancer research has been slow, and when used, outcomes have often been poorly measured. For instance, in a review of QOL measurement across a variety of medical conditions, Gill and Feinstein (10) found that 159 different measures of QOL were used in 75 studies, but fewer than half defined the target domains, only 17% included a patient-rated QOL, and just 9% elicited patients' preferences for health outcomes. Thus, there is a clear need for expanded research on practice-based outcomes measures. For such measures to be clinically relevant and feasible to collect, it is key that the research and clinical communities work together to take an active leadership role in this process. To set the stage for such activities, we review the current use of health outcomes across the spectrum of breast cancer care—from primary prevention and early detection through survivorship or death—that could be used as the basis of a research agenda for measuring the outcomes of breast cancer care. This review is intended to serve as a focal point for discussion and extension of existing efforts to improve the outcomes of breast cancer services. Methods We conducted a qualitative review of the literature on breast cancer health outcomes across all phases of breast cancer care, including primary prevention, early detection, diagnosis, local treatment, adjuvant treatment, treatment of metastatic disease, survivorship, and the dying experience (11). Conceptualization and Definition of Health Outcomes Outcomes research is the study of the net effects of the health care process on the health and well-being of individuals and populations. As such, it can encompass a wide breadth of issues, including research on satisfaction with care, effectiveness, costs of care, and measurement of patient preferences and QOL. The current construct of QOL draws on earlier use of social indicators, such as housing and employment status, to measure the well-being of populations (12-14). Breslow (15) expanded the measurement of population well-being to include the World Health Organization definition of health as “not only the absence of disease or of disability, but an overall state of physical, mental, and social well-being.” de Haes (16) later defined QOL as “the subjective evaluation of life as a whole,” and Cella and Cherin (17) expanded this definition to include patients' satisfaction with their level of functioning compared with an ideal level. Both of these latter definitions reflect the importance of the individual's subjective experience; the second definition highlights the role of personal values, or preferences, for health outcomes (3). The current consensus among outcomes researchers is that QOL is a multidimensional concept (3,18-23). The term “health-related QOL” (HRQOL) is used to refer to overall QOL in a health context (24). Although there is variation in the number and types of HRQOL domains suggested by different researchers, there is substantial overlap. Most researchers would agree that the following domains should be considered when deciding on HRQOL measures: 1) somatic concerns, such as pain and symptoms; 2) functional ability; 3) family well-being; 4) emotional well-being; 5) spirituality; 6) treatment satisfaction, including financial impact of illness; 7) future orientation; 8) sexuality, intimacy, and body image; 9) social functioning; 10) occupational functioning; and 11) preferences (3,22,25-28). The precise number and types of domains should be sufficiently broad to capture the impact of the illness or treatment on the patient but not to impose an undue burden on the patient or researcher; if the impact is largely unknown, the largest number of dimensions should be included while maintaining parsimony. Any one domain may be an outcome in and of itself. A 1991 National Cancer Institute-sponsored workshop on the measurement of QOL in cancer clinical trials (22) recommended that assessment be multidimensional, include general and cancer-specific tools, be patient self-reported, be measured at more than one point in time, and be evaluated after controlling for relevant medical and sociodemographic characteristics. These considerations guided our data abstraction. For the purposes of this review, health outcomes were defined as HRQOL or any of its domains, preferences for outcomes, satisfaction with health care or treatment decisions, and economic outcomes, such as costs of care, cost-effectiveness analysis (CEA), decision analysis, and cost-benefit analysis. Data Sources Multiple sources were used to identify all potential research for inclusion in the analysis. A MEDLINE search was conducted for all English language articles published during the period from January 1, 1990, through December 31, 2000. The earlier date of 1990 was selected to include research that was representative of current health outcomes and QOL research methods. The following key words were used for the search: Breast Neoplasms and Quality of Life, Health Status, Economics, Health Services Research, Delivery of Health Care, or Quality of Health Care. To limit our search more narrowly to QOL, satisfaction with health care or treatment decisions, or economic outcomes, our search of Quality of Health Care and Delivery of Health Care was restricted to articles listing these key words as a major MeSH term. For the other key words, we selected articles using these terms as major or minor MeSH headings. Because this search did not identify any articles on outcomes associated with the dying experience of breast cancer patients (other than survival), we conducted a supplemental search on this topic using the following terms: Palliative Care or Death and Dying and Breast Neoplasms or Cancer. Study Selection The “Methods” and “Results” sections were reviewed for eligibility by two investigators using a standardized abstraction form (29). Study inclusion criteria consisted of being conducted in the United States and Western Europe, being published in a peer-reviewed journal, and presenting data on a health outcome. We excluded 859 articles, including phase I or II randomized trials (n = 7), studies with fewer than 100 subjects (n = 67) (since there would be insufficient power for the majority of measures), reviews (n = 180), comments/letters (n = 140), reports focusing on outcomes methodology (n = 68), studies conducted outside the United States or Western Europe (n = 45) (for comparability of health care systems, attitudes, and culture), studies that did not include breast cancer (n = 7), and studies that did not include a QOL outcome (n = 345). If outcomes data, or data subsets, had been published in more than one journal or time period, the largest dataset that contained the highest quality of information was selected for abstraction, although all of the measures were noted. The full listing of articles retrieved by the search is available from the authors. Data Abstraction For studies eligible for inclusion, the following data were abstracted: the phase of care, study design, population characteristics (e.g., age and race), country, number of subjects, outcomes included, tools or methods used to measure these outcomes, language of measurement, assessment of comorbid conditions, mode of administration of measures, and whether the authors reported any reliability testing for instrument performance in their study population or a statement about the power to detect clinically meaningful differences in outcomes between groups. Data Analysis Data were summarized by use of descriptive statistics, Student's t tests for differences in means, analysis of variance for differences in groups, and chi-square tests for differences in proportions and trends over time. Results There were 1089 original research articles identified by the search; 230 (21%) of these met the criteria for study inclusion (seeAppendix Table 1) (30-264). These 230 articles reported on 155 distinct study samples. In the study period, there was a general increase in the number of articles that included breast cancer outcomes (Fig. 1; Table 1). This increase was largely due to increases in studies of QOL in the treatment and survivorship phases of care and economic studies of screening. Appendix Table 1. Characteristics of studies on the outcomes of primary prevention: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *BCPT = Breast Cancer Prevention Trial; CEA = cost-effectiveness analysis; LYS = life years saved; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; SEER = Surveillance, Epidemiology, and End Results [Program].   † See Table 3 for definitions of abbreviations of measures.   Lerman et al., 1995 (30)  Primary prevention   Cross-section   Female first-degree relatives of breast cancer patients aged 30-75 y; 96% white; United States   105   Anxiety, depression, impaired QOL   MHI; IES   Phone interview   Yes   N/A   Ganz et al., 1995 (96)  Primary prevention   RCT   Women enrolled in the BCPT comparing tamoxifen and placebo; >35 y old and at high risk for breast cancer or ≥60 y old; United States   9749   QOL   CES-D; MOS SF-36; BCPT Symptom Checklist; MOS sexual function   Self-administered   No   Yes   Stefanek et al., 1995 (32)  Primary prevention   Cross-section   Women with family history (≥1 first-degree relative) of breast cancer; 6-30 mo after surgery; United States   164   Satisfaction; depression, cancer-related worry   De novo tools; CES-D   Mail survey   No   Unknown   Nease and Ross, 1995 (33)  Primary prevention   Decision analysis   Women eligible for the BCPT; United States   N/A   Life expectancy   Survival   N/A   N/A   N/A   Schrag et al., 1997 (34)  Primary prevention   Decision analysis   Women at high-risk of BRCA 1/2 mutations; United States   N/A   LYS   Survival   N/A   N/A   N/A   Borgen et al., 1998 (35)  Primary prevention   Cross-section   Women 15 y (range, 1-50 y) after bilateral prophylactic mastectomy; mean age of 46 y at surgery (range, 25-73 y); 96% white; United States   370   Regrets about decision; satisfaction   De novo tool   Mail survey   No   N/A   Grann et al., 1999 (36) and 1998 (37)  Primary prevention   CEA   Ashkenazi Jewish women; United States   N/A   Utility; costs per LYS; QALYs   Medicare costs; survival; TTO (n = 54)   N/A   N/A   N/A   Grann et al., 1999 (38)  Primary prevention   Cross-section   Women aged 20-50 y with breast cancer, a personal history of multiple breast biopsies, or family history of breast cancer; United States   184   Preferences/utility; QOL   TTO; visual analog scale   N/A   N/A   N/A   Noe et al., 1999 (39)  Primary prevention   CEA   Women considered to be at high risk; received tamoxifen; enrolled in the National Surgical Adjuvant Breast and Bowel Project P-1 BCPT; United States   N/A   Utility; costs per life-year gained   Data on the benefits and risks of tamoxifen as observed in the BCPT   N/A   N/A   N/A   Brain et al., 2000 (40)  Primary prevention   RCT   Trial of Genetic Assessment in Breast Cancer (TRACE); Wales   735; subset of 545 at time of follow-up   QOL; costs   BCW; Satisfaction With Genetic Counseling Questionnaire; STAI; de novo tools   Self-administered   Yes   Unknown   Frost et al., 2000 (41)  Primary prevention   Cross-section   Women with family history who elected to undergo bilateral prophylactic mastectomy (1960-1993); United States   609; 94% response rate   QOL; long-term satisfaction   De novo tool   Mail survey   Yes   Unknown   Grann et al., 2000 (42)  Primary prevention   CEA   Women who tested positive for BRCA1/2 mutations; chemo-prevention with tamoxifen, raloxifene, or oral contraceptives vs. prophylactic surgery; United States   N/A   Preferences/utility; costs; QALY   Cumulative incidence rates from published literature; survival figures from SEER data; TTO to calculate QALYs; cost estimates based on Centers for Medicare and Medicaid Services payments, the SEER-Centers for Medicare and Medicaid Services database, and the Pharmacy Fundamental Reference         Julian-Reynier et al., 2000 (43)  Primary prevention   Cross-section   Women receiving genetic testing; France   471; 84% response rate   Patient willingness to diffuse information; attitude toward preventive options   De novo tools   Self-administered   No   Unknown   Smith and Hillner 2000 (44)  Primary prevention   CEA   Women enrolled in the National Surgical Adjuvant Breast Program P-1 BCPT receiving tamoxifen vs. placebo; United States   N/A   LYS; costs; preferences/utility   Medical care costs were estimated from the Agency for Health Care Policy and Research website; other parameters estimated from published literature   N/A   N/A   N/A   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *BCPT = Breast Cancer Prevention Trial; CEA = cost-effectiveness analysis; LYS = life years saved; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; SEER = Surveillance, Epidemiology, and End Results [Program].   † See Table 3 for definitions of abbreviations of measures.   Lerman et al., 1995 (30)  Primary prevention   Cross-section   Female first-degree relatives of breast cancer patients aged 30-75 y; 96% white; United States   105   Anxiety, depression, impaired QOL   MHI; IES   Phone interview   Yes   N/A   Ganz et al., 1995 (96)  Primary prevention   RCT   Women enrolled in the BCPT comparing tamoxifen and placebo; >35 y old and at high risk for breast cancer or ≥60 y old; United States   9749   QOL   CES-D; MOS SF-36; BCPT Symptom Checklist; MOS sexual function   Self-administered   No   Yes   Stefanek et al., 1995 (32)  Primary prevention   Cross-section   Women with family history (≥1 first-degree relative) of breast cancer; 6-30 mo after surgery; United States   164   Satisfaction; depression, cancer-related worry   De novo tools; CES-D   Mail survey   No   Unknown   Nease and Ross, 1995 (33)  Primary prevention   Decision analysis   Women eligible for the BCPT; United States   N/A   Life expectancy   Survival   N/A   N/A   N/A   Schrag et al., 1997 (34)  Primary prevention   Decision analysis   Women at high-risk of BRCA 1/2 mutations; United States   N/A   LYS   Survival   N/A   N/A   N/A   Borgen et al., 1998 (35)  Primary prevention   Cross-section   Women 15 y (range, 1-50 y) after bilateral prophylactic mastectomy; mean age of 46 y at surgery (range, 25-73 y); 96% white; United States   370   Regrets about decision; satisfaction   De novo tool   Mail survey   No   N/A   Grann et al., 1999 (36) and 1998 (37)  Primary prevention   CEA   Ashkenazi Jewish women; United States   N/A   Utility; costs per LYS; QALYs   Medicare costs; survival; TTO (n = 54)   N/A   N/A   N/A   Grann et al., 1999 (38)  Primary prevention   Cross-section   Women aged 20-50 y with breast cancer, a personal history of multiple breast biopsies, or family history of breast cancer; United States   184   Preferences/utility; QOL   TTO; visual analog scale   N/A   N/A   N/A   Noe et al., 1999 (39)  Primary prevention   CEA   Women considered to be at high risk; received tamoxifen; enrolled in the National Surgical Adjuvant Breast and Bowel Project P-1 BCPT; United States   N/A   Utility; costs per life-year gained   Data on the benefits and risks of tamoxifen as observed in the BCPT   N/A   N/A   N/A   Brain et al., 2000 (40)  Primary prevention   RCT   Trial of Genetic Assessment in Breast Cancer (TRACE); Wales   735; subset of 545 at time of follow-up   QOL; costs   BCW; Satisfaction With Genetic Counseling Questionnaire; STAI; de novo tools   Self-administered   Yes   Unknown   Frost et al., 2000 (41)  Primary prevention   Cross-section   Women with family history who elected to undergo bilateral prophylactic mastectomy (1960-1993); United States   609; 94% response rate   QOL; long-term satisfaction   De novo tool   Mail survey   Yes   Unknown   Grann et al., 2000 (42)  Primary prevention   CEA   Women who tested positive for BRCA1/2 mutations; chemo-prevention with tamoxifen, raloxifene, or oral contraceptives vs. prophylactic surgery; United States   N/A   Preferences/utility; costs; QALY   Cumulative incidence rates from published literature; survival figures from SEER data; TTO to calculate QALYs; cost estimates based on Centers for Medicare and Medicaid Services payments, the SEER-Centers for Medicare and Medicaid Services database, and the Pharmacy Fundamental Reference         Julian-Reynier et al., 2000 (43)  Primary prevention   Cross-section   Women receiving genetic testing; France   471; 84% response rate   Patient willingness to diffuse information; attitude toward preventive options   De novo tools   Self-administered   No   Unknown   Smith and Hillner 2000 (44)  Primary prevention   CEA   Women enrolled in the National Surgical Adjuvant Breast Program P-1 BCPT receiving tamoxifen vs. placebo; United States   N/A   LYS; costs; preferences/utility   Medical care costs were estimated from the Agency for Health Care Policy and Research website; other parameters estimated from published literature   N/A   N/A   N/A   View Large Fig. 1. View largeDownload slide Time trends in numbers of breast cancer outcomes research articles: 1990 through 2000 (seeTable 1 for breakdown by phase of care). Fig. 1. View largeDownload slide Time trends in numbers of breast cancer outcomes research articles: 1990 through 2000 (seeTable 1 for breakdown by phase of care). Table 1. Number of included articles on breast cancer outcomes* published during 1990 through 2000; breakdown of articles by year and phase of cancer care*   1990   1991   1992   1993   1994   1995   1996   1997   1998   1999   2000   Total, n   *Chi-square for trend P<.001. Total adds to more than 230 articles because some studies assessed more than one phase of care.   Primary prevention   0   0   0   0   0   4   0   1   2   3   5   15   Screening   2   2   5   2   3   3   2   4   10   7   1   41   Diagnosis   1   1   1   2   0   0   2   2   2   6   2   19   Local treatment   1   1   2   1   0   2   2   7   6   10   4   36   Adjuvant treatment   0   4   5   5   1   1   7   1   5   11   5   45   Treatment of metastatic disease   0   2   2   1   1   4   5   1   3   12   8   39   Survivorship and surveillance   1   0   1   2   4   7   5   5   16   7   3   51        Total   5   10   16   13   9   21   23   21   44   56   28   246     1990   1991   1992   1993   1994   1995   1996   1997   1998   1999   2000   Total, n   *Chi-square for trend P<.001. Total adds to more than 230 articles because some studies assessed more than one phase of care.   Primary prevention   0   0   0   0   0   4   0   1   2   3   5   15   Screening   2   2   5   2   3   3   2   4   10   7   1   41   Diagnosis   1   1   1   2   0   0   2   2   2   6   2   19   Local treatment   1   1   2   1   0   2   2   7   6   10   4   36   Adjuvant treatment   0   4   5   5   1   1   7   1   5   11   5   45   Treatment of metastatic disease   0   2   2   1   1   4   5   1   3   12   8   39   Survivorship and surveillance   1   0   1   2   4   7   5   5   16   7   3   51        Total   5   10   16   13   9   21   23   21   44   56   28   246   View Large Among the 230 articles, the most common outcome reported was HRQOL (54.4%) followed by costs/economic outcomes (38.3%), whereas there were statistically significantly fewer satisfaction (13.9%) or preference (9%) outcomes reported (P<.001). The proportion of these different types of outcomes varied across phase of care, with studies of survivorship having the greatest proportion of outcomes focused on QOL (69.1%) and studies of screening (9.7%) and diagnostic care (0%) having the lowest proportion of QOL outcomes (P<.001). These latter two phases had the highest proportion of economic studies compared with the other phases of care (P<.001) (data not shown). These findings are likely to be due to the nature of screening and diagnosis where the QOL outcomes are short term and difficult to capture, whereas the economic impact of differing strategies on survival may be large. We did not identify any studies about the quality of the dying experience for breast cancer patients per se. Within the metastatic treatment phase, there were 10 studies about palliative care that met our inclusion criteria (52-61); most were cross-sectional in design. The studies measured “will to live” (55), pain and symptom control (52-54,56,60,61), satisfaction (58), psychologic distress (52,57), and insight into prognosis (56). One study measured outcomes of the patients' caregivers (59). Among the study sample, the most prevalent type of study was an economic study (n = 91); 65.9% of these were CEAs and 24.2% were descriptions of the costs of care (Table 2). Among the 139 noneconomic studies, slightly more than one half (55.4%) were controlled studies (RCTs, longitudinal cohorts, or case-control studies), whereas almost one half were uncontrolled cross-sectional analyses. In a comparison of study design by phase of care, there were twice as many RCTs among studies of local and metastatic disease phases of care than among studies of other phases, whereas an uncontrolled, cross-sectional design was employed twice as often in studies of the survivorship phase of care as in studies of other phases (P<.01). Table 2. Study design in outcomes research by phase of breast cancer care   Study design     Phase of care   RCT*  Cohort   Cross-sectional   Economic†   Case-control   Total‡   *Randomized controlled trial.   † Economic studies include cost-effectiveness analyses, costs of care, and decision analyses.   ‡ Totals add to more than 230 because some studies assessed more than one phase of care.   Primary prevention   2   0   6   7   0   15   Screening, diagnosis   1   2   7   50   0   60   Local treatment   36   3   15   25   2   81   Treatment of metastatic disease   24   3   1   11   0   39   Survivorship and surveillance   9   10   28   2   2   51        Total   72   18   57   95   4   246     Study design     Phase of care   RCT*  Cohort   Cross-sectional   Economic†   Case-control   Total‡   *Randomized controlled trial.   † Economic studies include cost-effectiveness analyses, costs of care, and decision analyses.   ‡ Totals add to more than 230 because some studies assessed more than one phase of care.   Primary prevention   2   0   6   7   0   15   Screening, diagnosis   1   2   7   50   0   60   Local treatment   36   3   15   25   2   81   Treatment of metastatic disease   24   3   1   11   0   39   Survivorship and surveillance   9   10   28   2   2   51        Total   72   18   57   95   4   246   View Large The overwhelming majority of studies focused on white populations speaking the dominant language; only 24 (62-85) included more than 10% minority patients, and only three (68,70,86) reported more than 30% minority subjects. Five studies (69,87-90) noted use of translation of outcomes assessments into another language or languages. Few studies [e.g., (76,91-93)] concentrated on elderly women (women aged ≥65 years). There was a wide variety of instruments used in the study sample (Table 3) (94-195). The most commonly used tool was the Medical Outcomes Study SF-36 (8), but no single instrument was used in more than 10% of the studies (Table 4). Among the 139 noneconomic studies, 54.0% (n = 75) used previously validated tools, 20.1% (n = 28) relied solely on nonvalidated measurements developed de novo for the study, 19.4% (n = 27) used a combination of validated and de novo instruments, and 2.1% (n = 2) did not state what measures were used (see Appendix Tables 1, 2, 3, 4, 5, 6, 7). There were 127 validated tools represented in the 75 studies that used one or more validated measures. The average number of instruments used per noneconomic study was 2.8 (range, 1-10). Studies about survivorship or local therapy had the highest average number of measures per study (3.7 and 2.9, respectively), and studies of screening, metastatic disease, and primary prevention used the lowest number of measures per study (1.7, 2, and 2.1, respectively). With the exception of the studies of chemotherapy-induced nausea and vomiting-prevention interventions, all QOL studies included more than one domain of QOL. Table 3. Measures used in studies of breast cancer outcomes: 1990 through 2000 ADL = Activities of Daily Living (108)   ADQ = Adherence Determinants Questionnaire (94)   Andrews and Withey Quality of Life = Social Indicators of Well-Being (95)   BCPT Symptom Checklist = Breast Cancer Prevention Trial Symptom Checklist (96)   BCQ = Breast Cancer Quality of Life (97)   BCW = Breast Cancer Worries Scale (98)   BDI = Beck Depression Inventory (99)   Bedford College Life Events and Difficulties Schedules (100)   Berkman's Social Network Index (101)   BES = Body Esteem Scale (102)   bFs = Befindlichkeits-Skala (103)   Blatt Menopausal Index (104)   BPI = Brief Pain Inventory (105)   Bradburn's Positive Affect Scale (106)   Canada Health and Activity Limitation Survey (107)   Cancer Problem Scale (109)   Caplan Role and Emotional Function (110)   CARES = Cancer Rehabilitation and Evaluation System (111)   CDIS = Cancer Diagnostic Interview Scale (113)   CES-D = Center for Epidemiologic Studies—Depression (114)   Chalder Fatigue Scale (115)   Complex Figure Test (116)   D2 test (117)   DAS = Dyadic Adjustment Scale (121)   de Groot's Symptom Transition Scale (118)   Digit span of WAIS = digit span of Weschler Adult Intelligence Scale (119)   Duke-UNC Functional Social Support Questionnaire (120)   Eating Patterns Questionnaire (122)   ECOG (i.e., Eastern Cooperative Oncology Group) Analgesics Requirement Scale (123)   ECOG Performance Status (123)   Emotional Support Scale (160)   EORTC-QLQ-BR23 = European Organization for Research and Treatment of Cancer QLQ-BR23 (124)   EORTC-QLQ-C30 = European Organization for Research and Treatment of Cancer QLQ-C30 (125)   FACT = Functional Assessment of Cancer Illness Therapy (126)   FACT SP = Spirituality Profile (126)   Fepsy Tests (127)   FLIC = Functional Living Index—Cancer (128)   FPQLI = Ferrans and Powers Quality of Life Index (129)   Gaston-Johansson Pain-O-Meter (130)   GHQ = General Health Questionnaire (131)   HADS = Hospital Anxiety and Depression Scale (132)   House Social Support (133)   HQ = Health Questionnaire (134)   HSCL = Hopkins Symptoms Checklist (135)   IADL = Instrumental Activities of Daily Living (136)   IARB = Inventory of Adult Role Behavior and Self-Care (137)   IES = Impact of Event Scale (138)   Illness Intrusiveness Scale (139)   IWB = Index of Well-Being (140)   KPS = Karnofsky Performance Status (141)   Ladder = Self-Anchoring Scale of Hadley Cantril (142)   Lasry and Margoliese (143)   Lerman Cancer Worry Scale (144)   LES = Life Experiences Survey (145)   LWMAT = Locke-Wallace Martial Adjustment Test (146)   Massachusetts Women's Health Study Questionnaire (147)   McGill = McGill Pain Questionnaire (148)   Medical Research Council Quality of Life (149)   MHI = Mental Health Inventory of the Medical Outcomes Study (150)   Mini-MAC = Mini Mental Adjustment to Cancer (154)   MOS SF-36 = Medical Outcomes Study—Short Form 36 (151)   MOS Social Support Scale = Medical Outcomes Study Social Support Scale (152)   MPSSQ = Michigan Perceived Social Support Questionnaire (153)   MSAS = Memorial Symptom Assessment Scale (155)   Negative Affect Scale (156)   NHP = Nottingham Health Profile (157)   OTTAT = Oncology Treatment Toxicity Assessment Tool (158)   PACIS = Personal Adjustment to Chronic Illness (161)   PAIS-SR = Psychosocial Adjustment to Illness Scale (167)   PCQ = Psychological Consequences Questionnaire (168)   PDI = Pain Disability Index (159)   Perceived Social Support Scale (160)   Piper Fatigue Scale (162)   Pittsburgh Sleep Quality Index (163)   POMS = Profile of Mood States (166)   Postoperative Pain Questionnaire (164)   Principles of Living Survey (165)   PSI = Psychiatric Symptom Index (169)   Psychiatric Evaluation Form (170)   QOL-BC = Quality of Life in Breast Cancer (172)   QOL-CS = Quality of Life Cancer Survivors Tool (171)   Qtwist = Quality-Adjusted Time Without Symptoms or Toxicity (173)   Rand Health Survey (94)   Rey Auditory Verbal Learning Test (174)   Rosenberg's Scale of Self-Esteen (175)   RSCL = Rotterdam Symptom Checklist (176)   Satisfaction With Genetic Counseling Questionnaire (177)   SCID = Structured Clinical Interview Disease (178)   SCIWPR = Self-Care Inventory Wellness Promotion Scale (179)   SCL-90-R = Symptom Checklist (112)   SDS = Symptom Distress Scale (180)   Sexual Functioning Inventory (181)   SIP = Sickness Impact Profile (224)   Social Health Index (183)   Social Support Questionnaire (184)   STAI = State-Trait Anxiety Inventory (185)   Stroop Test (186)   SWLS = Statisfaction With Life Scale (187)   SWOG QOL Questionnaire = Southwest Oncology Group Quality of Life Questionnaire (188)   Symptom Experience Report (189)   Trial Making (190)   TTO = Time-tradeoff (191)   Urban Life Stress Scale (192)   Wisconsin Brief Pain Inventory Questionnaire (193)   WSFQ = Watts Sexual Function Questionnaire (194)   WTP = Willingness to Pay (195)   ADL = Activities of Daily Living (108)   ADQ = Adherence Determinants Questionnaire (94)   Andrews and Withey Quality of Life = Social Indicators of Well-Being (95)   BCPT Symptom Checklist = Breast Cancer Prevention Trial Symptom Checklist (96)   BCQ = Breast Cancer Quality of Life (97)   BCW = Breast Cancer Worries Scale (98)   BDI = Beck Depression Inventory (99)   Bedford College Life Events and Difficulties Schedules (100)   Berkman's Social Network Index (101)   BES = Body Esteem Scale (102)   bFs = Befindlichkeits-Skala (103)   Blatt Menopausal Index (104)   BPI = Brief Pain Inventory (105)   Bradburn's Positive Affect Scale (106)   Canada Health and Activity Limitation Survey (107)   Cancer Problem Scale (109)   Caplan Role and Emotional Function (110)   CARES = Cancer Rehabilitation and Evaluation System (111)   CDIS = Cancer Diagnostic Interview Scale (113)   CES-D = Center for Epidemiologic Studies—Depression (114)   Chalder Fatigue Scale (115)   Complex Figure Test (116)   D2 test (117)   DAS = Dyadic Adjustment Scale (121)   de Groot's Symptom Transition Scale (118)   Digit span of WAIS = digit span of Weschler Adult Intelligence Scale (119)   Duke-UNC Functional Social Support Questionnaire (120)   Eating Patterns Questionnaire (122)   ECOG (i.e., Eastern Cooperative Oncology Group) Analgesics Requirement Scale (123)   ECOG Performance Status (123)   Emotional Support Scale (160)   EORTC-QLQ-BR23 = European Organization for Research and Treatment of Cancer QLQ-BR23 (124)   EORTC-QLQ-C30 = European Organization for Research and Treatment of Cancer QLQ-C30 (125)   FACT = Functional Assessment of Cancer Illness Therapy (126)   FACT SP = Spirituality Profile (126)   Fepsy Tests (127)   FLIC = Functional Living Index—Cancer (128)   FPQLI = Ferrans and Powers Quality of Life Index (129)   Gaston-Johansson Pain-O-Meter (130)   GHQ = General Health Questionnaire (131)   HADS = Hospital Anxiety and Depression Scale (132)   House Social Support (133)   HQ = Health Questionnaire (134)   HSCL = Hopkins Symptoms Checklist (135)   IADL = Instrumental Activities of Daily Living (136)   IARB = Inventory of Adult Role Behavior and Self-Care (137)   IES = Impact of Event Scale (138)   Illness Intrusiveness Scale (139)   IWB = Index of Well-Being (140)   KPS = Karnofsky Performance Status (141)   Ladder = Self-Anchoring Scale of Hadley Cantril (142)   Lasry and Margoliese (143)   Lerman Cancer Worry Scale (144)   LES = Life Experiences Survey (145)   LWMAT = Locke-Wallace Martial Adjustment Test (146)   Massachusetts Women's Health Study Questionnaire (147)   McGill = McGill Pain Questionnaire (148)   Medical Research Council Quality of Life (149)   MHI = Mental Health Inventory of the Medical Outcomes Study (150)   Mini-MAC = Mini Mental Adjustment to Cancer (154)   MOS SF-36 = Medical Outcomes Study—Short Form 36 (151)   MOS Social Support Scale = Medical Outcomes Study Social Support Scale (152)   MPSSQ = Michigan Perceived Social Support Questionnaire (153)   MSAS = Memorial Symptom Assessment Scale (155)   Negative Affect Scale (156)   NHP = Nottingham Health Profile (157)   OTTAT = Oncology Treatment Toxicity Assessment Tool (158)   PACIS = Personal Adjustment to Chronic Illness (161)   PAIS-SR = Psychosocial Adjustment to Illness Scale (167)   PCQ = Psychological Consequences Questionnaire (168)   PDI = Pain Disability Index (159)   Perceived Social Support Scale (160)   Piper Fatigue Scale (162)   Pittsburgh Sleep Quality Index (163)   POMS = Profile of Mood States (166)   Postoperative Pain Questionnaire (164)   Principles of Living Survey (165)   PSI = Psychiatric Symptom Index (169)   Psychiatric Evaluation Form (170)   QOL-BC = Quality of Life in Breast Cancer (172)   QOL-CS = Quality of Life Cancer Survivors Tool (171)   Qtwist = Quality-Adjusted Time Without Symptoms or Toxicity (173)   Rand Health Survey (94)   Rey Auditory Verbal Learning Test (174)   Rosenberg's Scale of Self-Esteen (175)   RSCL = Rotterdam Symptom Checklist (176)   Satisfaction With Genetic Counseling Questionnaire (177)   SCID = Structured Clinical Interview Disease (178)   SCIWPR = Self-Care Inventory Wellness Promotion Scale (179)   SCL-90-R = Symptom Checklist (112)   SDS = Symptom Distress Scale (180)   Sexual Functioning Inventory (181)   SIP = Sickness Impact Profile (224)   Social Health Index (183)   Social Support Questionnaire (184)   STAI = State-Trait Anxiety Inventory (185)   Stroop Test (186)   SWLS = Statisfaction With Life Scale (187)   SWOG QOL Questionnaire = Southwest Oncology Group Quality of Life Questionnaire (188)   Symptom Experience Report (189)   Trial Making (190)   TTO = Time-tradeoff (191)   Urban Life Stress Scale (192)   Wisconsin Brief Pain Inventory Questionnaire (193)   WSFQ = Watts Sexual Function Questionnaire (194)   WTP = Willingness to Pay (195)   View Large Table 4. Instruments most commonly used in breast cancer outcomes studies: 1990 through 2000 Instrument   No. of studies (%)   Author of instrument, reference No.   MOS SF-36 = Medical Outcomes Study—Shortform 36   20 (8.7)   (151)  EORTC-QLQ-C30 = European Organization for Research and Treatment of Cancer QLQ-C30   15 (6.5)   (125)  CARES = Cancer Rehabilitation and Evaluation System   11 (4.8)   (111)  FLIC = Functional Living Index—Cancer   10 (4.4)   (228)  CES-D = Center for Epidemiologic Studies—Depression   8 (3.5)   (114)  RSCL = Rotterdam Symptom Checklist   8 (3.5)   (176)  HADS = Hospital Anxiety and Depression Scale   7 (3.0)   (132)  Linear Rating Scale   6 (2.6)     POMS = Profile of Mood States   6 (2.6)   (166)  BCPT Symptom Checklist = Breast Cancer Prevention Trial Symptom Checklist   5 (2.2)   (31)  KPS = Karnofsky Performance Status   5 (2.2)   (226)  IES = Impact of Event Scale   4 (1.7)   (138)  LES = Life Experiences Survey   4 (1.7)   (145)  STAI = State-Trait Anxiety Inventory   4 (1.7)   (185)  TTO = Time-tradeoff   4 (1.7)   (191)  Instrument   No. of studies (%)   Author of instrument, reference No.   MOS SF-36 = Medical Outcomes Study—Shortform 36   20 (8.7)   (151)  EORTC-QLQ-C30 = European Organization for Research and Treatment of Cancer QLQ-C30   15 (6.5)   (125)  CARES = Cancer Rehabilitation and Evaluation System   11 (4.8)   (111)  FLIC = Functional Living Index—Cancer   10 (4.4)   (228)  CES-D = Center for Epidemiologic Studies—Depression   8 (3.5)   (114)  RSCL = Rotterdam Symptom Checklist   8 (3.5)   (176)  HADS = Hospital Anxiety and Depression Scale   7 (3.0)   (132)  Linear Rating Scale   6 (2.6)     POMS = Profile of Mood States   6 (2.6)   (166)  BCPT Symptom Checklist = Breast Cancer Prevention Trial Symptom Checklist   5 (2.2)   (31)  KPS = Karnofsky Performance Status   5 (2.2)   (226)  IES = Impact of Event Scale   4 (1.7)   (138)  LES = Life Experiences Survey   4 (1.7)   (145)  STAI = State-Trait Anxiety Inventory   4 (1.7)   (185)  TTO = Time-tradeoff   4 (1.7)   (191)  View Large Appendix Table 2. Characteristics of studies on the outcomes of screening: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *CBE = clinical breast exam; CEA = cost-effective analysis; FN = false negative; FP = false positive; HC = health care; LYS = life years saved; N/A = not available; PCQ = psychological consequences questionnaire; QALY = quality-adjusted life years; RCT = randomized controlled trial.   † SeeTable 3 for definitions of abbreviations of measures.   Haiart et al., 1990 (45)  Screening   Costs of care   Mobile mammography using single view for women 40-65 y old; Scotland   6080   Costs; feasibility   Direct costs in NHP; patient time, travel, and lost opportunity costs   N/A   N/A   N/A   Gram et al., 1990 (46)  Screening   Cross-section   Women with negative and false-positive mammograms 6 mo after screen; average age 47 y; Norway   278; 89% response rate   QOL   Ladder; WTP; TTO; de novo anxiety and depression items   Mail survey   No   Unknown   Smith et al., 1991 (47)  Screening   RCT   Women attending the Leicestershire Breast Screening Service for abnormal mammograms; United Kingdom   103; 87% response rate   Satisfaction   De novo tool   In-person interview; mail survey   No   Unknown   Zappa et al., 1995 (227)  Screening   Costs of care   Population screening of women aged 50-70 y; Italy   38 676   Costs per woman screened; cost per cancer detected   Costs of recruitment, screening, and follow-up from the NHP   N/A   N/A   N/A   de Haes et al., 1991 (228); de Koning et al., 1991 (229)  Screening   CEA   Women of different ages and intervals of screening; The Netherlands   N/A   Costs per LYS; costs per QALYs   Costs and charges; survival; utilities from expert opinion (n = 27) with the use of published literature   Not stated   N/A   N/A   Brown, 1992 (230)  Screening   CEA   Women ≥50 y old; test effects of increasing age; United States   N/A   Costs; LYS   Direct medical costs only; survival based on published literature   N/A   N/A   N/A   Zavertnik et al., 1992 (231)  Screening   Costs of care   Costs of delivering low-cost mammography; United States   9452   Costs per cancer detected   Fixed and variable costs of screening program; cases detected   N/A   N/A   N/A   Mandelblatt et al., 1992 (76)  Screening   Decision analysis/CEA   Women aged ≥65 y with comorbid illnesses; black and white; United States   N/A   Costs; LYS; QALYs   Direct medical costs only; survival based on published literature; utility estimated from expert opinion   Not stated   N/A   N/A   Vaile et al., 1993 (232)  Screening   Longitudinal cohort   Women aged 50-64 y invited for screening who attended and had a negative test; England   2060; 65% response rate; 12% lost to follow-up   Satisfaction   De novo tool   Mail survey   No   No   Roworth et al., 1993 (233)  Screening   Cross-section   Women aged 50-64 y attending screening; Scotland   3000; 86% response rate   Satisfaction with screening; pain and pressure experienced; intention to return   Cockburn Satisfaction With Screening Tool; de novo questions   Mail survey   No   Unknown   Richardson et al., 1994 (234)  Screening   Cross-section   Women aged 50-64 y attending screening in urban and rural areas; New Zealand (included since dealing with satisfaction with screening—very few studies)   474; 93% response rate   Satisfaction with screening; anxiety   De novo tool   Mail survey   No   Unknown   Nutting et al., 1994 (77)  Screening   CEA   Mammogram + CBE vs. CBE in community of 750 American Indian women aged ≥50 y; United States   N/A   Costs; deaths averted; 5-y survival   Indian health service costs; survival based on published literature   N/A   N/A   N/A   Beemsterboer et al., 1994 (235)  Screening   CEA   Women aged 50-69 y; Germany   N/A   Costs per LYS   Direct medical costs; survival with the use of local data   N/A   N/A   N/A   Boer et al., 1995 (236) and 1998 (237)  Screening   CEA   Determination of upper-age limit for screening; The Netherlands   N/A   Costs per QALYs   Direct medical care costs; survival; utilities with the use of published data; source for utilities not described   N/A   N/A   N/A   Brown et al., 1995 (240)  Screening   CEA of nonrandom trial   Screening using one-vs. two-view mammography among women aged 50-64 y; England   26 430   Costs per cancer detected   Costs of screen and diagnostic follow-up in NHS; patient time costs   N/A   N/A   N/A   Feig, 1995 (239)  Screening   CEA   Women aged 40-49 y; United States   N/A   Costs of screening and diagnosis per woman screened or per LYS   Charges and cost estimates based on published literature   N/A   N/A   N/A   Brown et al., 1996 (240)  Screening   CEA   Mammography among women aged 50-64 y; one vs. two readings with or without consensus on films; England   33 734   Costs per cancer detected   Direct medical and nonmedical care costs to NHS and women based on local data   N/A   N/A   N/A   Evans et al., 1996 (241)  Screening   CEA   Women aged 50-64 y; Spain   100 000   Costs per cancer detected   Costs based on local data   N/A   N/A   N/A   Mandelblatt et al., 1997 (78)  Screening   CEA   Women seeking care in an urban public hospital emergency room; United States   N/A   Costs per LYS   Direct medical care costs and hospital charges; survival based on local data and published literature   N/A   N/A   N/A   Salzmann et al., 1997 (242)  Screening   CEA   Women starting mammography at ages 40-49 y vs. 50-69 y; United States   N/A   Costs; LYS   Direct medical costs only; survival based on published literature   N/A   N/A   N/A   Torgerson and Gosden, 1997 (243)  Screening   CEA   Women aged 66-69 y vs. 51-65 y; England   N/A   Deaths averted; LYS   Age-specific effects; number of deaths and survival; assumes resources are equal in the 2 age groups   N/A   N/A   N/A   Warmerdam et al., 1997 (244)  Screening   CEA   Women aged 50-69 y; The Netherlands   N/A   Costs; LYS   Costs in the German HC system; survival based on published literature and local data   N/A   N/A   N/A   Bakker et al., 1998 (245)  Screening   Cross-section; description   Convenient sample of women ≥50 y old (mean age, 61 y; range, 50-85 y) interviewed after mammography; Canada   256; 81% response rate   Satisfaction; distress   PCQ; de novo items   Telephone interview   No   No   Boer et al., 1998 (237)  Screening   CEA   Women living in the northwest region of England   N/A   Preferences/utility; costs; life-years saved; number of deaths prevented   Screening and cost data from the NHS breast-screening program   N/A   N/A   N/A   Gilbert et al., 1998 (246)  Screening   Cohort; longitudinal   Women aged 50-64 y following a false-positive screening mammography; Scotland   124   Psychologic distress   HADS; health questionnaire   Self-administered; mail survey; in-person interview   No   Unknown   Johnston et al., 1998 (206)  Screening   Cross-section   Women aged 40-64 y screened within 6 mo of screen or invited to be screened; England   440   Preferences for temporary states (FP, FN, etc.)   TTO   In-person interview   Yes   Yes   Lamarque et al., 1998 (247)  Screening   CEA   Women aged 40-60 y; France   N/A   Costs per case detected   Direct and non-direct medical costs (travel and time); biopsyproven disease based on local data   N/A   N/A   N/A   Rosenquist and Lindfors, 1998 (248)  Screening   CEA   Women beginning screening at age 40 y at different intervals until age 79 y; United States   N/A   Incremental costs per LYS   Direct medical costs; survival based on published literature   N/A   N/A   N/A   Schweitzer et al., 1998 (79)  Screening   CEA   Low-income black and Hispanic women using a mobile mammography van; United States   N/A   Costs per cancer detected   Microcosting of actual van services; biopsy-proven cancer based on published literature   N/A   N/A   N/A   Boer et al., 1998, (237)  Screening   CEA   Women at 2-y vs. 3-y intervals; stop screening at age 64 y vs. age 69 y; England   N/A   Costs; LYS   NHS costs; survival based on published literature   N/A   N/A   N/A   Wolstenholme et al., 1998 (249)  Screening   CEA   Costs of screening, incorporating the downstream costs of treatment among a regional sample diagnosed in 1991; England   137   Costs; LYS   Costs in the NHS; observed survival based on published literature and local data   N/A   N/A   N/A   Allen et al., 1999 (250)  Screening   CEA   Sestamibi scintimammography for women >40 y old with dense breasts; United States   N/A   Preferences/utility; costs   Single time-point analysis   N/A   N/A   N/A   Boer et al., 1999 (51)  Screening   CEA   Women aged ≥65 y; The Netherlands   N/A   Preferences/ utility; costs; LYS; extra incidence; extra life-years with disease   Data from the Dutch screening projects   N/A   N/A   N/A   Gyrd-Hansen, 1999 (251)  Screening   CEA   Costs of screening for colorectal, cervical, and breast cancers from national health care sector perspective; Denmark   N/A   Preferences/utility; costs   Published data from Swedish and Dutch screening programs and trials   N/A   N/A   N/A   Leivo et al., 1999 (252)  Screening   CEA   Women aged 50-64 y screened in the Finnish nationwide screening program (1987-1992); Finland   90 000   Preferences/utility; costs; LYS   Published studies and national cancer statistics, health market sources   N/A   N/A   N/A   Norum, 1999 (253)  Screening   CEA   Women aged 50-64 y screened every 2 y in a demonstration program; Norway   46 329   Costs per cancer detected; costs per LYS   Costs in the screening project; survival with the use of local data; production gains or losses   N/A   N/A   N/A   Secker-Walker et al., 1999 (91)  Screening   Costs of care   Women attending screening in 2 geographic areas; majority 65-79 y old (range, <50-80+); United States   445; 49% response rate   Patient time and costs associated with screening and diagnosis   Time and travel time; out-of-pocket costs   Telephone interview   No   Unknown   van der Pol et al., 1999 (254)  Screening   CEA   Women in sparsely populated areas; island communities of Scotland   N/A   Preferences/utility; costs   Time and travel costs   N/A   N/A   No   Haas et al., 2000 (84)  Screening   Cross-section   Women who had abnormal mammograms or mammography for clinical breast concern; United States   751; 77% response rate   Quality of care   Cross-sectional patient survey and medical record review   Telephone interview   No   Unknown   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *CBE = clinical breast exam; CEA = cost-effective analysis; FN = false negative; FP = false positive; HC = health care; LYS = life years saved; N/A = not available; PCQ = psychological consequences questionnaire; QALY = quality-adjusted life years; RCT = randomized controlled trial.   † SeeTable 3 for definitions of abbreviations of measures.   Haiart et al., 1990 (45)  Screening   Costs of care   Mobile mammography using single view for women 40-65 y old; Scotland   6080   Costs; feasibility   Direct costs in NHP; patient time, travel, and lost opportunity costs   N/A   N/A   N/A   Gram et al., 1990 (46)  Screening   Cross-section   Women with negative and false-positive mammograms 6 mo after screen; average age 47 y; Norway   278; 89% response rate   QOL   Ladder; WTP; TTO; de novo anxiety and depression items   Mail survey   No   Unknown   Smith et al., 1991 (47)  Screening   RCT   Women attending the Leicestershire Breast Screening Service for abnormal mammograms; United Kingdom   103; 87% response rate   Satisfaction   De novo tool   In-person interview; mail survey   No   Unknown   Zappa et al., 1995 (227)  Screening   Costs of care   Population screening of women aged 50-70 y; Italy   38 676   Costs per woman screened; cost per cancer detected   Costs of recruitment, screening, and follow-up from the NHP   N/A   N/A   N/A   de Haes et al., 1991 (228); de Koning et al., 1991 (229)  Screening   CEA   Women of different ages and intervals of screening; The Netherlands   N/A   Costs per LYS; costs per QALYs   Costs and charges; survival; utilities from expert opinion (n = 27) with the use of published literature   Not stated   N/A   N/A   Brown, 1992 (230)  Screening   CEA   Women ≥50 y old; test effects of increasing age; United States   N/A   Costs; LYS   Direct medical costs only; survival based on published literature   N/A   N/A   N/A   Zavertnik et al., 1992 (231)  Screening   Costs of care   Costs of delivering low-cost mammography; United States   9452   Costs per cancer detected   Fixed and variable costs of screening program; cases detected   N/A   N/A   N/A   Mandelblatt et al., 1992 (76)  Screening   Decision analysis/CEA   Women aged ≥65 y with comorbid illnesses; black and white; United States   N/A   Costs; LYS; QALYs   Direct medical costs only; survival based on published literature; utility estimated from expert opinion   Not stated   N/A   N/A   Vaile et al., 1993 (232)  Screening   Longitudinal cohort   Women aged 50-64 y invited for screening who attended and had a negative test; England   2060; 65% response rate; 12% lost to follow-up   Satisfaction   De novo tool   Mail survey   No   No   Roworth et al., 1993 (233)  Screening   Cross-section   Women aged 50-64 y attending screening; Scotland   3000; 86% response rate   Satisfaction with screening; pain and pressure experienced; intention to return   Cockburn Satisfaction With Screening Tool; de novo questions   Mail survey   No   Unknown   Richardson et al., 1994 (234)  Screening   Cross-section   Women aged 50-64 y attending screening in urban and rural areas; New Zealand (included since dealing with satisfaction with screening—very few studies)   474; 93% response rate   Satisfaction with screening; anxiety   De novo tool   Mail survey   No   Unknown   Nutting et al., 1994 (77)  Screening   CEA   Mammogram + CBE vs. CBE in community of 750 American Indian women aged ≥50 y; United States   N/A   Costs; deaths averted; 5-y survival   Indian health service costs; survival based on published literature   N/A   N/A   N/A   Beemsterboer et al., 1994 (235)  Screening   CEA   Women aged 50-69 y; Germany   N/A   Costs per LYS   Direct medical costs; survival with the use of local data   N/A   N/A   N/A   Boer et al., 1995 (236) and 1998 (237)  Screening   CEA   Determination of upper-age limit for screening; The Netherlands   N/A   Costs per QALYs   Direct medical care costs; survival; utilities with the use of published data; source for utilities not described   N/A   N/A   N/A   Brown et al., 1995 (240)  Screening   CEA of nonrandom trial   Screening using one-vs. two-view mammography among women aged 50-64 y; England   26 430   Costs per cancer detected   Costs of screen and diagnostic follow-up in NHS; patient time costs   N/A   N/A   N/A   Feig, 1995 (239)  Screening   CEA   Women aged 40-49 y; United States   N/A   Costs of screening and diagnosis per woman screened or per LYS   Charges and cost estimates based on published literature   N/A   N/A   N/A   Brown et al., 1996 (240)  Screening   CEA   Mammography among women aged 50-64 y; one vs. two readings with or without consensus on films; England   33 734   Costs per cancer detected   Direct medical and nonmedical care costs to NHS and women based on local data   N/A   N/A   N/A   Evans et al., 1996 (241)  Screening   CEA   Women aged 50-64 y; Spain   100 000   Costs per cancer detected   Costs based on local data   N/A   N/A   N/A   Mandelblatt et al., 1997 (78)  Screening   CEA   Women seeking care in an urban public hospital emergency room; United States   N/A   Costs per LYS   Direct medical care costs and hospital charges; survival based on local data and published literature   N/A   N/A   N/A   Salzmann et al., 1997 (242)  Screening   CEA   Women starting mammography at ages 40-49 y vs. 50-69 y; United States   N/A   Costs; LYS   Direct medical costs only; survival based on published literature   N/A   N/A   N/A   Torgerson and Gosden, 1997 (243)  Screening   CEA   Women aged 66-69 y vs. 51-65 y; England   N/A   Deaths averted; LYS   Age-specific effects; number of deaths and survival; assumes resources are equal in the 2 age groups   N/A   N/A   N/A   Warmerdam et al., 1997 (244)  Screening   CEA   Women aged 50-69 y; The Netherlands   N/A   Costs; LYS   Costs in the German HC system; survival based on published literature and local data   N/A   N/A   N/A   Bakker et al., 1998 (245)  Screening   Cross-section; description   Convenient sample of women ≥50 y old (mean age, 61 y; range, 50-85 y) interviewed after mammography; Canada   256; 81% response rate   Satisfaction; distress   PCQ; de novo items   Telephone interview   No   No   Boer et al., 1998 (237)  Screening   CEA   Women living in the northwest region of England   N/A   Preferences/utility; costs; life-years saved; number of deaths prevented   Screening and cost data from the NHS breast-screening program   N/A   N/A   N/A   Gilbert et al., 1998 (246)  Screening   Cohort; longitudinal   Women aged 50-64 y following a false-positive screening mammography; Scotland   124   Psychologic distress   HADS; health questionnaire   Self-administered; mail survey; in-person interview   No   Unknown   Johnston et al., 1998 (206)  Screening   Cross-section   Women aged 40-64 y screened within 6 mo of screen or invited to be screened; England   440   Preferences for temporary states (FP, FN, etc.)   TTO   In-person interview   Yes   Yes   Lamarque et al., 1998 (247)  Screening   CEA   Women aged 40-60 y; France   N/A   Costs per case detected   Direct and non-direct medical costs (travel and time); biopsyproven disease based on local data   N/A   N/A   N/A   Rosenquist and Lindfors, 1998 (248)  Screening   CEA   Women beginning screening at age 40 y at different intervals until age 79 y; United States   N/A   Incremental costs per LYS   Direct medical costs; survival based on published literature   N/A   N/A   N/A   Schweitzer et al., 1998 (79)  Screening   CEA   Low-income black and Hispanic women using a mobile mammography van; United States   N/A   Costs per cancer detected   Microcosting of actual van services; biopsy-proven cancer based on published literature   N/A   N/A   N/A   Boer et al., 1998, (237)  Screening   CEA   Women at 2-y vs. 3-y intervals; stop screening at age 64 y vs. age 69 y; England   N/A   Costs; LYS   NHS costs; survival based on published literature   N/A   N/A   N/A   Wolstenholme et al., 1998 (249)  Screening   CEA   Costs of screening, incorporating the downstream costs of treatment among a regional sample diagnosed in 1991; England   137   Costs; LYS   Costs in the NHS; observed survival based on published literature and local data   N/A   N/A   N/A   Allen et al., 1999 (250)  Screening   CEA   Sestamibi scintimammography for women >40 y old with dense breasts; United States   N/A   Preferences/utility; costs   Single time-point analysis   N/A   N/A   N/A   Boer et al., 1999 (51)  Screening   CEA   Women aged ≥65 y; The Netherlands   N/A   Preferences/ utility; costs; LYS; extra incidence; extra life-years with disease   Data from the Dutch screening projects   N/A   N/A   N/A   Gyrd-Hansen, 1999 (251)  Screening   CEA   Costs of screening for colorectal, cervical, and breast cancers from national health care sector perspective; Denmark   N/A   Preferences/utility; costs   Published data from Swedish and Dutch screening programs and trials   N/A   N/A   N/A   Leivo et al., 1999 (252)  Screening   CEA   Women aged 50-64 y screened in the Finnish nationwide screening program (1987-1992); Finland   90 000   Preferences/utility; costs; LYS   Published studies and national cancer statistics, health market sources   N/A   N/A   N/A   Norum, 1999 (253)  Screening   CEA   Women aged 50-64 y screened every 2 y in a demonstration program; Norway   46 329   Costs per cancer detected; costs per LYS   Costs in the screening project; survival with the use of local data; production gains or losses   N/A   N/A   N/A   Secker-Walker et al., 1999 (91)  Screening   Costs of care   Women attending screening in 2 geographic areas; majority 65-79 y old (range, <50-80+); United States   445; 49% response rate   Patient time and costs associated with screening and diagnosis   Time and travel time; out-of-pocket costs   Telephone interview   No   Unknown   van der Pol et al., 1999 (254)  Screening   CEA   Women in sparsely populated areas; island communities of Scotland   N/A   Preferences/utility; costs   Time and travel costs   N/A   N/A   No   Haas et al., 2000 (84)  Screening   Cross-section   Women who had abnormal mammograms or mammography for clinical breast concern; United States   751; 77% response rate   Quality of care   Cross-sectional patient survey and medical record review   Telephone interview   No   Unknown   View Large Appendix Table 3. Characteristics of studies on the outcomes of diagnosis: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *AND = axillary node dissection; CBE = clinical breast exam; CEA = cost-effectiveness analysis; CNB = core needle biopsy; FNA = fine-needle aspiration; GIVIO = Interdisciplinary Group for Cancer Care Evaluation; MD = medical doctor; N/A = not applicable; QALY = quality-adjusted life years; RCT = randomized controlled trial.   † SeeTable 3 for definitions of abbreviations of measures.   Kennedy et al,. 1991 (255)  Diagnosis   Costs of care   Women being evaluated for staging: England   103   Costs per detection of bone metastases   Costs in NHP   N/A   N/A   N/A   Mosconi et al., 1991 (256)  Diagnosis   Cross-section   Women in GIVIO RCT; stages I, II, and III, age <70 y; Italy   1171: 81.5% response rate   Satisfaction with communication; information received   De novo items   Mail survey   N/A   Unknown   McManus et al., 1992 (257)  Diagnosis   Costs of care   Women with needle localization biopsies for nonpalpable lesions vs. triaging mammograms by probability of malignancy and use of selective biopsy; Canada   332   Costs per biopsy; avoided biopsy costs   Direct costs of biopsy in the national health system   N/A   N/A   N/A   Layfield et al., 1993 (258)  Diagnosis   CEA   FNA vs. open biopsy in women with palpable masses and negative mammography; United States   N/A   Costs per 10-y survival   Diagnostic charges at one center and Medicare costs for ongoing treatment and follow-up; survival   N/A   N/A   N/A   Velanovich, 1995 (259)  Diagnosis   CEA   Immediate biopsy vs. repeat mammagraphy in 6 mo women with abnormal mammograms; United States   N/A   Costs per QALY   Based on published literature   N/A   N/A   N/A   Fajardo, 1996 (260)  Diagnosis   Costs of care   Women with nonpalpable lesions seen on mammography evaluated with stereotaxic core needle biopsy; United, States   400   Costs per case correctly diagnosed vs. delayed vs. missed diagnosis   Costs in one institution based on cost-to-charge ratio   N/A   N/A   N/A   Vetto et al., 1996 (262)  Diagnosis   Costs of care   CBE, sonogram, and FNA vs. CBE and open biopsy for women <40 y old with papable lesions; mean age 33 y; United States   55 (included because of paucity of dx studies)   Costs per correct diagnosis   Charges   N/A   N/A   N/A   Hillner 1997 (262)  Diagnosis   CEA   Sestamibi vs. core biopsy vs. open biopsy in women with nonpalpable lesions; United States   N/A   Costs; number of cancer diagnoses missed; number of delayed diagnoses   Institutional costs; missed or delayed diagnosis of cancer based on published literature and RCT   N/A   N/A   N/A   Rubin et., 1997 (263)  Diagnosis   Costs of care   FNA to avoid open biopsy in women with palpable lesions: United States   N/A   Costs saved per averted biopsy   Biopsy charges   N/A   N/A   N/A   Logan-Young et al., 1998 (264)  Diagnosis   CEA   FNA vs. core vs. open biopsy in one practice; United States   > 40 000 patients   Costs per case diagnosed   Charges based on case series; cancer cases   N/A   N/A   N/A   Velanovich, 1998 (265)  Diagnosis   Decision analysis   AND in patients with lesions <2 cm; United States   N/A   QALYs   Survival; utilities from expert and patient opinion or literature; values not given   N/A   N/A   N/A   Burkhardt and Sunshine, 1999 (266)  Diagnosis   Costs of care   Costs of biopsy methods (core needle and open surgery); United States   N/A   Costs   Costs; charges; actual payments; excludes “overhead costs”   N/A   N/A   N/A   Heimdal et al., 1999 (267)  Diagnosis   CEA   Cost-effectiveness of survelliance program for women at risk for inherited disease; Norway   N/A   Preference/utility; costs   Based on results from surveillance program; Norwegian National Insurance Service reimbursement fees   N/A   N/A   N/A   Hrung et al., 1999 (268)  Diagnosis   CEA   Imaging and CNB Magnetic resonance in the preoperative work-up of suspicious breast lesions; United States   N/A   Preferences/utility; costs   Stage-specific cancer prevalence, tumor recurrence, progression rates, and magnetic resonance imaging and CNB sensitivity and specificity were obtained from published literature. Cost estimates were obtained from the literature and from the Medicare fee schedule   N/A   N/A   N/A   Boer et al., 1999 (51)  Diagnosis   CEA   Two-view mammography at incident screens; England and Wales   N/A   Perferences/utility; costs   Previously collected data from screening programs   N/A   N/A   N/A   Leivo et al., 1999 (269)  Diagnosis   CEA   Nationwide semiannual screening program for women 50-59 y old; Finland   95 423; 91% participation rate   Preferences/utility; costs   All mammographies performed during 1990-1995 in 3 screening centers of the Finnish Cancer Society   N/A   N/A   N/A   Orr et al., 1999 (270)  Diagnosis   CEA   Sentinel node biopsy vs. AND; threshold of accuracy (learning curve); United States   10 000 women per arm   Costs, % correct staging; survival; QALYs;   Costs; survival; MD-rated utility based on published literature   N/A   N/A   N/A   Allen et al., 2000 (49)  Diagnosis   CEA   Sestamibi scintimammography; with mammography; United States   N/A   Preferences/utility; costs   Based on Medicare reimbursement values   N/A   N/A   N/A   Morris et al., 2000 (212)  Diagnosis   CEA   Women who underwent wire-guided open breast biopsy; United States   164   Preferences/utility; costs   Biopsy records review; Current Procedure Terminology-based charges   N/A   N/A   N/A   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *AND = axillary node dissection; CBE = clinical breast exam; CEA = cost-effectiveness analysis; CNB = core needle biopsy; FNA = fine-needle aspiration; GIVIO = Interdisciplinary Group for Cancer Care Evaluation; MD = medical doctor; N/A = not applicable; QALY = quality-adjusted life years; RCT = randomized controlled trial.   † SeeTable 3 for definitions of abbreviations of measures.   Kennedy et al,. 1991 (255)  Diagnosis   Costs of care   Women being evaluated for staging: England   103   Costs per detection of bone metastases   Costs in NHP   N/A   N/A   N/A   Mosconi et al., 1991 (256)  Diagnosis   Cross-section   Women in GIVIO RCT; stages I, II, and III, age <70 y; Italy   1171: 81.5% response rate   Satisfaction with communication; information received   De novo items   Mail survey   N/A   Unknown   McManus et al., 1992 (257)  Diagnosis   Costs of care   Women with needle localization biopsies for nonpalpable lesions vs. triaging mammograms by probability of malignancy and use of selective biopsy; Canada   332   Costs per biopsy; avoided biopsy costs   Direct costs of biopsy in the national health system   N/A   N/A   N/A   Layfield et al., 1993 (258)  Diagnosis   CEA   FNA vs. open biopsy in women with palpable masses and negative mammography; United States   N/A   Costs per 10-y survival   Diagnostic charges at one center and Medicare costs for ongoing treatment and follow-up; survival   N/A   N/A   N/A   Velanovich, 1995 (259)  Diagnosis   CEA   Immediate biopsy vs. repeat mammagraphy in 6 mo women with abnormal mammograms; United States   N/A   Costs per QALY   Based on published literature   N/A   N/A   N/A   Fajardo, 1996 (260)  Diagnosis   Costs of care   Women with nonpalpable lesions seen on mammography evaluated with stereotaxic core needle biopsy; United, States   400   Costs per case correctly diagnosed vs. delayed vs. missed diagnosis   Costs in one institution based on cost-to-charge ratio   N/A   N/A   N/A   Vetto et al., 1996 (262)  Diagnosis   Costs of care   CBE, sonogram, and FNA vs. CBE and open biopsy for women <40 y old with papable lesions; mean age 33 y; United States   55 (included because of paucity of dx studies)   Costs per correct diagnosis   Charges   N/A   N/A   N/A   Hillner 1997 (262)  Diagnosis   CEA   Sestamibi vs. core biopsy vs. open biopsy in women with nonpalpable lesions; United States   N/A   Costs; number of cancer diagnoses missed; number of delayed diagnoses   Institutional costs; missed or delayed diagnosis of cancer based on published literature and RCT   N/A   N/A   N/A   Rubin et., 1997 (263)  Diagnosis   Costs of care   FNA to avoid open biopsy in women with palpable lesions: United States   N/A   Costs saved per averted biopsy   Biopsy charges   N/A   N/A   N/A   Logan-Young et al., 1998 (264)  Diagnosis   CEA   FNA vs. core vs. open biopsy in one practice; United States   > 40 000 patients   Costs per case diagnosed   Charges based on case series; cancer cases   N/A   N/A   N/A   Velanovich, 1998 (265)  Diagnosis   Decision analysis   AND in patients with lesions <2 cm; United States   N/A   QALYs   Survival; utilities from expert and patient opinion or literature; values not given   N/A   N/A   N/A   Burkhardt and Sunshine, 1999 (266)  Diagnosis   Costs of care   Costs of biopsy methods (core needle and open surgery); United States   N/A   Costs   Costs; charges; actual payments; excludes “overhead costs”   N/A   N/A   N/A   Heimdal et al., 1999 (267)  Diagnosis   CEA   Cost-effectiveness of survelliance program for women at risk for inherited disease; Norway   N/A   Preference/utility; costs   Based on results from surveillance program; Norwegian National Insurance Service reimbursement fees   N/A   N/A   N/A   Hrung et al., 1999 (268)  Diagnosis   CEA   Imaging and CNB Magnetic resonance in the preoperative work-up of suspicious breast lesions; United States   N/A   Preferences/utility; costs   Stage-specific cancer prevalence, tumor recurrence, progression rates, and magnetic resonance imaging and CNB sensitivity and specificity were obtained from published literature. Cost estimates were obtained from the literature and from the Medicare fee schedule   N/A   N/A   N/A   Boer et al., 1999 (51)  Diagnosis   CEA   Two-view mammography at incident screens; England and Wales   N/A   Perferences/utility; costs   Previously collected data from screening programs   N/A   N/A   N/A   Leivo et al., 1999 (269)  Diagnosis   CEA   Nationwide semiannual screening program for women 50-59 y old; Finland   95 423; 91% participation rate   Preferences/utility; costs   All mammographies performed during 1990-1995 in 3 screening centers of the Finnish Cancer Society   N/A   N/A   N/A   Orr et al., 1999 (270)  Diagnosis   CEA   Sentinel node biopsy vs. AND; threshold of accuracy (learning curve); United States   10 000 women per arm   Costs, % correct staging; survival; QALYs;   Costs; survival; MD-rated utility based on published literature   N/A   N/A   N/A   Allen et al., 2000 (49)  Diagnosis   CEA   Sestamibi scintimammography; with mammography; United States   N/A   Preferences/utility; costs   Based on Medicare reimbursement values   N/A   N/A   N/A   Morris et al., 2000 (212)  Diagnosis   CEA   Women who underwent wire-guided open breast biopsy; United States   164   Preferences/utility; costs   Biopsy records review; Current Procedure Terminology-based charges   N/A   N/A   N/A   View Large Appendix Table 4. Characteristics of studies on the short-term outcomes of local treatment: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ALND = axillary lymph node dissection; AND = axillary node dissection; CEA = cost-effectiveness analysis; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy.   † SeeTable 3 for definitions of abbreviations of measures.   Verhoef et al., 1991 (271)  Local treatment   CEA   Women receiving BCS vs. MST, compared for recurrence   N/A   Costs per QALY   Costs; survival with the use of published data; source of costs or types of costs not included; no data on how utilities were derived   N/A   N/A   N/A   Ganz et al., 1990 (273), 1992 (73, 272), 1993 (274)  Local treatment   RCT   Women with state I or II cancer enrolled in trial comparing rehabilitation case management with minimal intervention after surgery; compares MST with BCS; 15% black; United States   229 [109 in (73,273)]; 139 in 50% response rate   QOL; symptoms   FLIC; CARES; KPS; POMS; GAIS   In-person interview   No   Unknown   August et al., 1995 (275)  Local treatment   Cross-section   Women attending a multidisciplinary breast cancer service; average age approximately 50 y; United States   601; 59% response rate   Satisfaction   De novo tool   Mail survey   Yes   Unknown   Holcombe et al., 1995 (265)  Local treatment   Cross-section   Women after AND; mean age 59 y (range, 29-76 y), England   101   Satisfaction   De novo tool   Unknown   No   Unknown   Legorreta et al., 1996 (277)  Local treatment   Costs of care   Women with newly diagnosed breast cancers in a health maintenance organization population (U.S. Healthcare, Blue Bell, PA); mean age 54 y (range, 29-82 y); United States   200   4-y costs; clinical stage; use of mammography screening   Medical records; claims data; all health maintenance organization expenditures for non-primary care services   N/A   N/A   N/A   Maunsell et al., 1996 (278)  Local treatment   RCT   Women newly diagnosed with local- or regional-stage disease at 1 regional cancer center from 1990 to 1992; counseling plus monthly telephone screening vs. counseling only; Canada   261; 96% response rate   Distress; QOL; marital satisfaction; return to usual activities   QHC; social support questionnaire; LES; LWMAT; Psychiatric Symptom Index; Canada Health and Activity Limitation Survey   In-person interview; telephone interview   Yes   Unknown   Berry et al., 1998 (279)  Local treatment   Cross-section   Women undergoing breast reconstruction with a prosthesis at a median age of 52 y (range, 25-74 y); England   100   Satisfaction   De novo tool   Mail survey   No   Unknown   Degner et al., 1997 (280)  Local treatment   Cross-section   Women treated for breast cancer seen in 2 cancer centers and 2 community oncology clinics; mean age 58 y (±12.7 y); Canada   1012   Preferences about participation in treatment decisions; information needs   De novo tool   In-person interview   Yes   Unknown   Gabel et al., 1997 (223)  Local treatment   Case-control; historical controls   Patients seen before and after institution of a multidisciplinary breast cancer clinic at a teaching hospital; United States   339; bias: 67% response for control subjects and 44% for case subjects   Satisfaction; time to treatment   Unknown   Mail survey   No   Unknown   Hayman et al., 1997 (281)  Local treatment   Cross-section   Women with stage I or II cancer who underwent BCS plus RT; 6-24 mo after treatment; United States   117   Preferences   Standard Gamble   In-person interview   No   Unknown   Liljegren et al., 1997 (282)  Local treatment   CEA of RCT; 5-y time horizon   Patients with stage I disease who were <80 y old when receiving BCS and AND ± RT; Sweden   381   Incremental costs; QALYs (double counted production loss and disutility)   Direct and nondirect medical costs, production costs; survival; primary data collection; intend to Rx; utility from MDs   N/A   N/A   N/A   Norum et al., 1997 (196)  Local treatment   CEA   Stage I or II; Norway   N/A   Incremental costs; QALYs   Direct and nondirect medical costs based on published literature; survival; patient-rated utility with the use of Euro-QoL   N/A   N/A   N/A   Weitzner et al., 1997 (74)  Local treatment   Cross-section   Women treated with MRM plus adjuvant therapy; age <70 y (mean age 54 y) surviving >5 y from stage I, II, or III breast cancer compared with control subjects with normal screening; 13% black; United States   153   QOL   BDI; STAI; FPQLI   Self-administered   No   Unknown   Andrykowski et al., 1998 (283)  Local treatment   RCT   Women ≥18 y old with a first-time diagnosis of stage 0, I, II, or IIIA disease with a history of fine-needle aspiration and/or diagnosis or fibrocystic disease; United States   176   QOL; fatigue   MOS SF-36; CES-D; Chalder Fatigue Scale; Piper Fatigue Scale; Pittsburgh Sleep Quality Index; Symptom Experience Report   Mail survey   Yes   Unknown   Bonnema et al., 1998 (284)  Local treatment   RCT   RCT of short or long stay in postsurgical hospital; stage I or II disease, follow-up of 4 mo; The Netherlands   125   QOL; satisfaction   De novo items   Self-administered   Yes   Unknown   Bonnema et al., 1998 (284,285)  Local treatment   Cost minimization based on RCT   RCT of short or long stay in postsurgical hospital; stage I or II disease, follow-up of 4 mo; The Netherlands   139; 79 completed 4-month diaries   Costs per arm 4-mo postsurgical period   Direct and nondirect medical costs; patient diaries for resource use; national costs   Self-administered   N/A   N/A   Hayman et al., 1998 (286)  Local treatment   CEA using local and published data   Compare RT after BCS with no RT in a cohort of 60-y-old women; United States   N/A   Costs per QALY   Charges at one institution and nonmedical directs (time, travel); survival; utilities; standard gamble in a sample of 97 patients   N/A   N/A   N/A   Maslin et al., 1998 (287)  Local treatment   RCT   Women with local disease and mean age 52 y (range, 28-73 y) randomly assigned to interactive video support plus team vs. multidisciplinary shared decision-making; England   100; subset response rate 94% for QOL   QOL; acceptability of video   MOS SF-36; HADS; de novo tool satisfaction   Self-administered   No   Unknown   Burstein et al., 1999 (288)  Local treatment   Longitudinal cohort   Women with stages I or II disease; United States   480; 69% response rate; 73% completed follow-up   QOL; use of alternative medicine   MOS SF-36; MOS sexual satisfaction; CES-D; NCPT symptom checklist; Lasry and Margoles Fear of Recurrence Scale   In-person interview   No   Unknown   Frost et al., 1999 (289)  Local treatment   Cross-section   Newly diagnosed women who received their medical oncology consult in a hospital vs. in a multidisciplinary outpatient clinic; United States   121; 72% response rate   QOL; satisfaction   CARES; de novo tool   Self-administered   Yes   Unknown   Ganz et al., 1999 (81)  Local treatment   Cross-section   Women in a partnered relationship and sexually active in the past 6 mo with a diagnosis of stage 0, I, or II disease; living in Los Angeles, CA, or in Washington, DC; United States   1134   Sexual health   CARES Body Image Subscale; Sexual Functioning Inventory Scale; Sexual Interest and Dysfunction Subscale; BCPT Symptom Checklist; revised DAS; RAND Health Survey; WSFQ   Mail survey   No   Unknown   Hack et al., 1999 (290)  Local treatment   Cross-section   Women who had ALND at least 6 mo before without advanced disease; Canada   89.5% response rate   QOL; pain; mental health   Range of arm/shoulder motion; modified Postoperative Pain Questionnaire; PDI; short-form McGill Pain Questionnaire; EORTC QLQ-C30   In-person interview   No   Unknown   Marks et al., 1999 (65)  Local treatment   CEA   Women undergoing postmastectomy RT; United States   N/A   Cost per QALY; cost per averted relapse   Charges; nonmedical direct costs of time and travel; survival with the use of published literature   N/A   N/A   N/A   Pusic et al., 1999 (83)  Local treatment   Cross-section   Women who had a lumpectomy with RT or a mastectomy listed in the hospital tumor registry and plastic surgery clinical records; United States and Canada   525; 50.9% response rate   QOL; patient choice   MOS SF-36; Illness Intrusiveness Scale   Self-administered   No   Unknown   Shimozuma et al., 1999 (86)  Local treatment   RCT   Women who lived in Los Angeles County, CA; randomly assigned to MRM vs. BCT; United States   227   QOL   CARES; KPS; POMS   In-person interview   No   Unknown   Wang et al., 1999 (75)  Local treatment   Cross-section   Women seen for first follow-up after surgery; mean age 49 y (range, 27-78 y); 84% white; United States   102   QOL; concerns and needs   De novo tool   In-person interview   No   Unknown   Wengstrom et al., 1999 (291)  Local treatment   RCT   Women beginning curative RT; Sweden   175; 77% response rate   QOL   IES; OTTAT; CARES—short form   In-person interview; mail survey   Yes   Unknown   Wenzel 1999 (292)  Local treatment   Cross-section   Subset from intervention trial testing the efficacy of a telephone counseling program; United States   354; 86% response rate   QOL   CES-D; IES; Breast FACT-B; Sexual Functioning and Body Images Scale   Mail survey   Yes   Unknown   Hayman et al., 2000 (293)  Local treatment   CEA   Women with negative margins after conservative surgery who experienced an addition of an electrobeam boost to tangential RT; United States   N/A   Preferences/utility; costs; QALYS   Based on the Lyon trial   N/A   N/A   N/A   Mille et al., 2000 (294)  Local treatment   Costs of care   Compliant vs. noncompliant clinical practice guidelines; France   200   Cost evaluation from Social Security perspective; in medical practice   Number of medical procedures performed; medical records   N/A   N/A   Unknown   Palit et al., 2000 (295)  Local treatment   Costs of care   Women having breast conservation surgery or modified radical mastectomy; United States   230   Costs   Medical records and billing   N/A   N/A   Unknown   Whelan et al., 2000 (296)  Local treatment   RCT   Women treated by lumpectomy and ALND referred to specific cancer centers; Canada   837; 75% response rate at follow-up   QOL   Breast Cancer Chemotherapy Questionnaire (BCQ)   In-person interview   No   Unknown   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ALND = axillary lymph node dissection; AND = axillary node dissection; CEA = cost-effectiveness analysis; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy.   † SeeTable 3 for definitions of abbreviations of measures.   Verhoef et al., 1991 (271)  Local treatment   CEA   Women receiving BCS vs. MST, compared for recurrence   N/A   Costs per QALY   Costs; survival with the use of published data; source of costs or types of costs not included; no data on how utilities were derived   N/A   N/A   N/A   Ganz et al., 1990 (273), 1992 (73, 272), 1993 (274)  Local treatment   RCT   Women with state I or II cancer enrolled in trial comparing rehabilitation case management with minimal intervention after surgery; compares MST with BCS; 15% black; United States   229 [109 in (73,273)]; 139 in 50% response rate   QOL; symptoms   FLIC; CARES; KPS; POMS; GAIS   In-person interview   No   Unknown   August et al., 1995 (275)  Local treatment   Cross-section   Women attending a multidisciplinary breast cancer service; average age approximately 50 y; United States   601; 59% response rate   Satisfaction   De novo tool   Mail survey   Yes   Unknown   Holcombe et al., 1995 (265)  Local treatment   Cross-section   Women after AND; mean age 59 y (range, 29-76 y), England   101   Satisfaction   De novo tool   Unknown   No   Unknown   Legorreta et al., 1996 (277)  Local treatment   Costs of care   Women with newly diagnosed breast cancers in a health maintenance organization population (U.S. Healthcare, Blue Bell, PA); mean age 54 y (range, 29-82 y); United States   200   4-y costs; clinical stage; use of mammography screening   Medical records; claims data; all health maintenance organization expenditures for non-primary care services   N/A   N/A   N/A   Maunsell et al., 1996 (278)  Local treatment   RCT   Women newly diagnosed with local- or regional-stage disease at 1 regional cancer center from 1990 to 1992; counseling plus monthly telephone screening vs. counseling only; Canada   261; 96% response rate   Distress; QOL; marital satisfaction; return to usual activities   QHC; social support questionnaire; LES; LWMAT; Psychiatric Symptom Index; Canada Health and Activity Limitation Survey   In-person interview; telephone interview   Yes   Unknown   Berry et al., 1998 (279)  Local treatment   Cross-section   Women undergoing breast reconstruction with a prosthesis at a median age of 52 y (range, 25-74 y); England   100   Satisfaction   De novo tool   Mail survey   No   Unknown   Degner et al., 1997 (280)  Local treatment   Cross-section   Women treated for breast cancer seen in 2 cancer centers and 2 community oncology clinics; mean age 58 y (±12.7 y); Canada   1012   Preferences about participation in treatment decisions; information needs   De novo tool   In-person interview   Yes   Unknown   Gabel et al., 1997 (223)  Local treatment   Case-control; historical controls   Patients seen before and after institution of a multidisciplinary breast cancer clinic at a teaching hospital; United States   339; bias: 67% response for control subjects and 44% for case subjects   Satisfaction; time to treatment   Unknown   Mail survey   No   Unknown   Hayman et al., 1997 (281)  Local treatment   Cross-section   Women with stage I or II cancer who underwent BCS plus RT; 6-24 mo after treatment; United States   117   Preferences   Standard Gamble   In-person interview   No   Unknown   Liljegren et al., 1997 (282)  Local treatment   CEA of RCT; 5-y time horizon   Patients with stage I disease who were <80 y old when receiving BCS and AND ± RT; Sweden   381   Incremental costs; QALYs (double counted production loss and disutility)   Direct and nondirect medical costs, production costs; survival; primary data collection; intend to Rx; utility from MDs   N/A   N/A   N/A   Norum et al., 1997 (196)  Local treatment   CEA   Stage I or II; Norway   N/A   Incremental costs; QALYs   Direct and nondirect medical costs based on published literature; survival; patient-rated utility with the use of Euro-QoL   N/A   N/A   N/A   Weitzner et al., 1997 (74)  Local treatment   Cross-section   Women treated with MRM plus adjuvant therapy; age <70 y (mean age 54 y) surviving >5 y from stage I, II, or III breast cancer compared with control subjects with normal screening; 13% black; United States   153   QOL   BDI; STAI; FPQLI   Self-administered   No   Unknown   Andrykowski et al., 1998 (283)  Local treatment   RCT   Women ≥18 y old with a first-time diagnosis of stage 0, I, II, or IIIA disease with a history of fine-needle aspiration and/or diagnosis or fibrocystic disease; United States   176   QOL; fatigue   MOS SF-36; CES-D; Chalder Fatigue Scale; Piper Fatigue Scale; Pittsburgh Sleep Quality Index; Symptom Experience Report   Mail survey   Yes   Unknown   Bonnema et al., 1998 (284)  Local treatment   RCT   RCT of short or long stay in postsurgical hospital; stage I or II disease, follow-up of 4 mo; The Netherlands   125   QOL; satisfaction   De novo items   Self-administered   Yes   Unknown   Bonnema et al., 1998 (284,285)  Local treatment   Cost minimization based on RCT   RCT of short or long stay in postsurgical hospital; stage I or II disease, follow-up of 4 mo; The Netherlands   139; 79 completed 4-month diaries   Costs per arm 4-mo postsurgical period   Direct and nondirect medical costs; patient diaries for resource use; national costs   Self-administered   N/A   N/A   Hayman et al., 1998 (286)  Local treatment   CEA using local and published data   Compare RT after BCS with no RT in a cohort of 60-y-old women; United States   N/A   Costs per QALY   Charges at one institution and nonmedical directs (time, travel); survival; utilities; standard gamble in a sample of 97 patients   N/A   N/A   N/A   Maslin et al., 1998 (287)  Local treatment   RCT   Women with local disease and mean age 52 y (range, 28-73 y) randomly assigned to interactive video support plus team vs. multidisciplinary shared decision-making; England   100; subset response rate 94% for QOL   QOL; acceptability of video   MOS SF-36; HADS; de novo tool satisfaction   Self-administered   No   Unknown   Burstein et al., 1999 (288)  Local treatment   Longitudinal cohort   Women with stages I or II disease; United States   480; 69% response rate; 73% completed follow-up   QOL; use of alternative medicine   MOS SF-36; MOS sexual satisfaction; CES-D; NCPT symptom checklist; Lasry and Margoles Fear of Recurrence Scale   In-person interview   No   Unknown   Frost et al., 1999 (289)  Local treatment   Cross-section   Newly diagnosed women who received their medical oncology consult in a hospital vs. in a multidisciplinary outpatient clinic; United States   121; 72% response rate   QOL; satisfaction   CARES; de novo tool   Self-administered   Yes   Unknown   Ganz et al., 1999 (81)  Local treatment   Cross-section   Women in a partnered relationship and sexually active in the past 6 mo with a diagnosis of stage 0, I, or II disease; living in Los Angeles, CA, or in Washington, DC; United States   1134   Sexual health   CARES Body Image Subscale; Sexual Functioning Inventory Scale; Sexual Interest and Dysfunction Subscale; BCPT Symptom Checklist; revised DAS; RAND Health Survey; WSFQ   Mail survey   No   Unknown   Hack et al., 1999 (290)  Local treatment   Cross-section   Women who had ALND at least 6 mo before without advanced disease; Canada   89.5% response rate   QOL; pain; mental health   Range of arm/shoulder motion; modified Postoperative Pain Questionnaire; PDI; short-form McGill Pain Questionnaire; EORTC QLQ-C30   In-person interview   No   Unknown   Marks et al., 1999 (65)  Local treatment   CEA   Women undergoing postmastectomy RT; United States   N/A   Cost per QALY; cost per averted relapse   Charges; nonmedical direct costs of time and travel; survival with the use of published literature   N/A   N/A   N/A   Pusic et al., 1999 (83)  Local treatment   Cross-section   Women who had a lumpectomy with RT or a mastectomy listed in the hospital tumor registry and plastic surgery clinical records; United States and Canada   525; 50.9% response rate   QOL; patient choice   MOS SF-36; Illness Intrusiveness Scale   Self-administered   No   Unknown   Shimozuma et al., 1999 (86)  Local treatment   RCT   Women who lived in Los Angeles County, CA; randomly assigned to MRM vs. BCT; United States   227   QOL   CARES; KPS; POMS   In-person interview   No   Unknown   Wang et al., 1999 (75)  Local treatment   Cross-section   Women seen for first follow-up after surgery; mean age 49 y (range, 27-78 y); 84% white; United States   102   QOL; concerns and needs   De novo tool   In-person interview   No   Unknown   Wengstrom et al., 1999 (291)  Local treatment   RCT   Women beginning curative RT; Sweden   175; 77% response rate   QOL   IES; OTTAT; CARES—short form   In-person interview; mail survey   Yes   Unknown   Wenzel 1999 (292)  Local treatment   Cross-section   Subset from intervention trial testing the efficacy of a telephone counseling program; United States   354; 86% response rate   QOL   CES-D; IES; Breast FACT-B; Sexual Functioning and Body Images Scale   Mail survey   Yes   Unknown   Hayman et al., 2000 (293)  Local treatment   CEA   Women with negative margins after conservative surgery who experienced an addition of an electrobeam boost to tangential RT; United States   N/A   Preferences/utility; costs; QALYS   Based on the Lyon trial   N/A   N/A   N/A   Mille et al., 2000 (294)  Local treatment   Costs of care   Compliant vs. noncompliant clinical practice guidelines; France   200   Cost evaluation from Social Security perspective; in medical practice   Number of medical procedures performed; medical records   N/A   N/A   Unknown   Palit et al., 2000 (295)  Local treatment   Costs of care   Women having breast conservation surgery or modified radical mastectomy; United States   230   Costs   Medical records and billing   N/A   N/A   Unknown   Whelan et al., 2000 (296)  Local treatment   RCT   Women treated by lumpectomy and ALND referred to specific cancer centers; Canada   837; 75% response rate at follow-up   QOL   Breast Cancer Chemotherapy Questionnaire (BCQ)   In-person interview   No   Unknown   View Large Appendix Table 5. Characteristics of studies on the outcomes of adjuvant therapy; January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *BMT = bone marrow transplant; CAF = combination chemotherapy with cyclophosphamide, doxorubicin, and 5-fluorouracil; CEA = cost-effectiveness analysis; CMF = combination chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil; EORTC = European Organization for Research and Treatment of Cancer; ER = estrogen receptor; LYS = life years saved; MD = medical doctor; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy.   † SeeTable 3 for definitions of abbreviations of measures.   Berglund et al., 1991 (297)  Adjuvant therapy   RCT; 2- to 10-y follow-up   Relapse-free survivors initially randomly assigned to receive RT vs. RT plus tamoxifen vs. adjuvant chemotherapy after MST; >3 cm; lymph node positive; age <65 y; mean age 58 y; Sweden; bias: excluded women with recurrences   448; 82% response rate   QOL   de novo tool; HADS; 32 symptoms   Mail survey   Yes for HADS   Unknown   Gelber et al., 1991 (298)  Adjuvant therapy   RCT   Women with lymph node-positive cancer; 1 vs. 6 cycles of chemotherapy plus tamoxifen; Europe   1229   QOL   Qtwist   Self and MD rated   No   Unknown   Love et al., 1991 (299)  Adjuvant treatment   RCT   Postmenopausal women <65 y old; lymph node-negative disease; 10 y after diagnosis; United States   140   QOL; symptoms   Gynecologic symptoms; de novo tools about QOL and anxiety   In-person interview   No   Unknown   Campora et al., 1992 (300)  Adjuvant treatment   Cross-section   Women undergoing chemotherapy (35 with metastatic disease); mean age 55 y (range, 30-70 y); Italy   137   QOL   De novo tool; physical, emotional, social, and symptom domains   In-person interview   No   Unknown   Hillner and Smith, 1992 (301); Hillner et al., 1993 (302); Smith and Hillner, 1993 (303); Hillner and Smith, 1992 (304); Hillner and Smith, 1991 (305)  Adjuvant treatment   CEA of published RCT data   Effects of using chemotherapy in women aged 45-80 y by lymph node and ER status; United States   N/A   Cost per LYS and QALYs   Direct medical care costs based on one hospital's charges and Medicare data; survival; physician-estimated utility   N/A   N/A   N/A   Hurny et al., 1992 (87)  Adjuvant therapy   RCT   Women receiving different numbers and timing of adjuvant chemotherapy cycles (3 vs. 6 and late reintroduction vs. not); Europe   854; 87% complete one QOL set; decrease to 70% over time   QOL   PACIS; LRS; bFs; POMS; HADS; translated into 11 languages   Self-administered   Yes   Unknown   Soukop et al., 1992 (207)  Adjuvant therapy   RCT   Women receiving chemotherapy; randomly assigned to receive ondansetron vs. metoclopramide; England   187   Emesis   Rates of emesis; severity of nausea   Self-administered   No   Yes   Clavel et al., 1993 (306)  Adjuvant therapy   RCT   Women receiving first course of chemotherapy and participating in 5 RCTs of ondansetron vs. placebo or metclopramide and alizapride   689   QOL; symptoms   RSCL; FLIC; FLIC emesis   Unknown   No   Unknown   Cox and Hirsch 1993 (307)  Adjuvant therapy   CEA   Comparison of ondansetron and metoclopramide in women receiving chemotherapy; United States   N/A   Costs per successfully treated patient (i.e., no emesis)   Average costs of drugs and medications to control adverse effects; time of providers caring for patients   N/A   N/A   N/A   Desch et al., 1993 (93)  Adjuvant therapy   CEA   Chemotherapy vs. no adjuvant therapy for women aged 60-80 y with ER-negative stage I cancer   N/A   Cost per LYS and QALYs; cost per active life expectancy   Direct medical care costs based on one hospital's charges and Medicare data; survival with the use of published data; physician-estimated utility   N/A   N/A   N/A   Mapelli et al., 1994 (308)  Adjuvant therapy   Costs of care in an RCT   Women with inflammatory breast cancer randomly assigned to receive high-dose FEC with or without lenograstim; Europe   120   Costs of care   Costs of direct medical resources consumed in the RCT   N/A   N/A   N/A   Clavel et al., 1995 (50)  Adjuvant therapy   RCT   Women receiving first course of chemotherapy and participating in RCT of ondansetron vs. alizapride to prevent emesis; France   254   QOL; symptoms   Symptom checklist; FLIC; FLIC emesis   Self-administered; in-person interview   No   Unknown   Barrenetxea et al., 1996 (309)  Adjuvant therapy   RCT   Women receiving mild emetogenic chemotherapy regimens; Spain   Unknown   QOL; emesis   FLIC; de novo tool   In-person interview   No   Unknown   Gelber et al., 1996 (310), 1998 (298)  Adjuvant therapy   RCT   Postmenopausal women aged ≥50 y with lymph node-positive disease; EBCTCG; standard chemotherapy plus tamoxifen vs. tamoxifen alone; Europe   3920   QOL   Qtwist; source of utility estimates not provided   N/A   N/A   Unknown   Hurny et al., 1996 (89)  Adjuvant therapy   RCT   Lymph node-positive women receiving CMF and booster cycles vs. CMF or CMF vs. tamoxifen; 10 languages; Europe   1248 premenopausal (85% response rate); 998 postmenopausal (83% response rate)   QOL   PACIS; bFs; LRS   Self-administered in clinic   No   Unknown   Lokich et al., 1996 (311)  Adjuvant therapy   Costs of care   Women receiving bolus vs. infusion administration of chemotherapy; United States   N/A   Cost per mode of administration   Charges including MD and/or clinic visit; laboratory; drug cost based on average wholesale price; cost of disposables; and pump rental fee   N/A   N/A   N/A   Longman et al., 1996 (312)  Adjuvant therapy   Cross-section   Women with mean age 55 y (range, 25-82 y) with all stages of disease; recent diagnosis and recurrences; United States   307   QOL   Side effects checklist; de Groot's Symptom Transition Scale; IARB; SCIWPR; Negative Affect Scale; IWB; Cantrill's Ladder   Unknown   Yes   Unknown   Messori et al., 1996 (313)  Adjuvant therapy   CEA using RCT data   CMF chemotherapy vs. none in women with lymph node-positive disease; Italy   388   Costs; LYS   Direct medical costs; survival “area under the curve” estimated by Gompertz function; assumes downstream costs are equal in both arms; no discounting   N/A   N/A   N/A   Hann et al., 1997 (314)  Adjuvant therapy; BMT   Case-control   Cancer center patients with BMT from 1990 to 1995; mean age 44 y (range, 32-57 y); United States   103; 86% response rate   QOL   MOS SF-36; KPS; MSAS   Mail survey   No   Unknown   Bernhard et al., 1998 (88); Hurny et al., 1996 (89)  Adjuvant therapy   RCT   Premenopausal women with lymph node-positive disease receiving CMF plus late CMF vs. CMF or postmenopausal women receiving tamoxifen vs. CMF (with or without delay booster); 9 languages; Europe   2687; subset response rate 82% for QOL   QOL   PACIS; LRS; bFs   Self-administered   No   Unknown   Carter et al., 1998 (315)  Adjuvant therapy   CEA   Treatment of early-stage breast cancer in the elderly; United States   N/A   Preference/utility; costs   Literature data; utilities were determined from the responses of health care professionals to a basic reference gamble   N/A   N/A   N/A   Fetting et al., 1998 (219)  Adjuvant therapy   RCT   Women with lymph node-positive, ER-negative disease randomly assigned to receive CAF in six cycles vs. 16 wk (16 wk includes methotrexate and vincristine); median age 47 y (range, 25-78 y); 15% black; United States   646; QOL data only available on 163; 87% complete all time points   QOL   BCQ   Unknown   No   Unknown   Frits et al., 1998 (316)  Adjuvant therapy   RCT   Women <55 y old with lymph node-positive cancer receiving tamoxifen plus standard chemotherapy vs. tamoxifen plus high-dose chemotherapy; controls without chemotherapy; The Netherlands   121   Cognitive impairment; QOL   Rey Auditory Verbal Learning Test; Complex Figure Test; digit span of WAIS; Trial Making; D2 test; Dutch aphasia test; Stroop Test; Fepsy Tests; EORTC-QLQ-C30; HSCL   In-person interview   No   Unknown   Bernhard et al., 1999 (317)  Adjuvant therapy   RCT   Women who failed prior adjuvant and/or palliative treatment with tamoxifen; randomly assigned to receive forestane vs. megestrol acetate; Switzerland   177; 83% response rate   QOL   De novo tools   Mail survey   No   Unknown   Day et al., 1999 (318)  Adjuvant therapy   Cohort   Women enrolled in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial   82% response rate   QOL   HRQL survey   Self-administered   No   Unknown   Fairclough et al., 1999 (82)  Adjuvant therapy   RCT   Women with hormone-reecptor-negative, lymph node-positive disease; United States   163; 87% response rate   QOL; quality-adjusted survival   Breast Chemotherapy Questionnaire (BCQ)   Self-administered   Yes   No   Gaston-Johansson et al., 1999 (319)  Adjuvant therapy   Cross-section   Women with stage II, III, or IV disease who were scheduled for autologous bone marrow/peripheral blood stem cell transplant; United States   127   Fatigue; pain; depression   Piper Fatigue Scale; MOS Short-form General Health Survey; Gaston-Johannsson Pain-O-Meter   Self-administered   No   Unknown   Hoerger et al., 1999 (320)  Adjuvant therapy   Costs of care   Women ≥45 y old using health care for cardiovascular disease, osteoporosis, breast cancer, or gynecologic cancers; United States   N/A   Costs; health care use   Data from Healthcare Cost and Utilization Project-3 (HCUP-3); national health care survey; discharge data; cost/charge ratios; Medicare fee schedule   N/A   N/A   N/A   Kurtz et al., 1999 (92)  Adjuvant therapy   Longitudinal cohort   Women >65 y old recruited for on-going study of 6 centers in Michigan; United States   383   QOL; comorbidity   MOS SF-36; Symptom Experience Scale   Unknown   No   Unknown   Macquart-Moulin et al., 1999 (321)  Adjuvant therapy   RCT   Women with <9 involved axillary lymph nodes; France   109; subset of 97 at follow-up   QOL; side effects   EORTC QLQ-C30; de novo tool   Self-administered   Yes   No   McKinna et al., 1999 (322)  Adjuvant therapy   RCT   Women with operable breast cancer and suitable for breast-conserving surgery (Jan. 1984-Dec. 1994) who were recommended a policy of observation to the lymphatic pathways; United Kingdom   291   Cancer-related morbidity   Case record review   N/A   N/A   N/A   Silber et al., 1998 (323)  Adjuvant therapy   CEA   Hypothetical cohort of women receiving chemotherapy; use of G-STF to prevent development of neutropenia; United States   N/A   Costs per LYS   Payor charges; survival with the use of published literature   N/A   N/A   N/A   Van Tiggelen et al., 1999 (324)  Adjuvant therapy   CEA   Comparison of oophorectomy with chemotherapy in premenopausal women; Belgium   N/A   Costs (assume equal effects based on one RCT)   Charges with the use of country-specified data   N/A   N/A   N/A   van Enckevort et al., 1999 (325)  Adjuant therapy   CEA   Women receiving chemotherapy, hormonal treatment, or both; The Netherlands   N/A   QALY; costs, preference/utility   Published studies (Jan 1980-Dec 1997)   N/A   N/A   N/A   Joly et al., 2000 (209)  Adjuvant therapy   RCT   Premenopausal women enrolled in a trial testing the efficacy of adjuvant CMF chemotherapy; lymph node negative; France   179; 68% response rate   QOL   EORTC QLQ-C30; EORTC QLQ-BR23   Mail survey   Yes   Unknown   Kramer et al., 2000 (326)  Adjuvant therapy   RCT   Women with baseline QL data from a trial of paclitaxel vs. doxorubicin as first-line chemotherapy; The Netherlands and Belgium   294; 64% response rate   QOL; survival effectiveness   EORTC QLQ-C30; RSCL   Self-administered   No   Unknown   Norum, 2000 (327)  Adjuvant therapy   CEA   Treatment with CMF; Norway   778 articles   QOL; preferences/utility; costs   MEDLINE English language literature with incorporated Norwegian Standard Act practice and cost data   N/A   N/A   N/A   Pandya et al., 2000 (328)  Adjuvant therapy   RCT   Postmenopausal patients experiencing at least one tamoxifen-induced hot flash per day; United States   194   QOL   Diary; de novo tools   Mail survey   No   No   Vrieling et al., 2000 (329)  Adjuvant therapy   RCT   Subset of women entered in the EORTC “boost vs. no-boost” trial of tumorectomy axillary dissection   1872   Cosmetic results   De novo tools   In-person interview   No   Unknown   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *BMT = bone marrow transplant; CAF = combination chemotherapy with cyclophosphamide, doxorubicin, and 5-fluorouracil; CEA = cost-effectiveness analysis; CMF = combination chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil; EORTC = European Organization for Research and Treatment of Cancer; ER = estrogen receptor; LYS = life years saved; MD = medical doctor; N/A = not available; QALY = quality-adjusted life years; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy.   † SeeTable 3 for definitions of abbreviations of measures.   Berglund et al., 1991 (297)  Adjuvant therapy   RCT; 2- to 10-y follow-up   Relapse-free survivors initially randomly assigned to receive RT vs. RT plus tamoxifen vs. adjuvant chemotherapy after MST; >3 cm; lymph node positive; age <65 y; mean age 58 y; Sweden; bias: excluded women with recurrences   448; 82% response rate   QOL   de novo tool; HADS; 32 symptoms   Mail survey   Yes for HADS   Unknown   Gelber et al., 1991 (298)  Adjuvant therapy   RCT   Women with lymph node-positive cancer; 1 vs. 6 cycles of chemotherapy plus tamoxifen; Europe   1229   QOL   Qtwist   Self and MD rated   No   Unknown   Love et al., 1991 (299)  Adjuvant treatment   RCT   Postmenopausal women <65 y old; lymph node-negative disease; 10 y after diagnosis; United States   140   QOL; symptoms   Gynecologic symptoms; de novo tools about QOL and anxiety   In-person interview   No   Unknown   Campora et al., 1992 (300)  Adjuvant treatment   Cross-section   Women undergoing chemotherapy (35 with metastatic disease); mean age 55 y (range, 30-70 y); Italy   137   QOL   De novo tool; physical, emotional, social, and symptom domains   In-person interview   No   Unknown   Hillner and Smith, 1992 (301); Hillner et al., 1993 (302); Smith and Hillner, 1993 (303); Hillner and Smith, 1992 (304); Hillner and Smith, 1991 (305)  Adjuvant treatment   CEA of published RCT data   Effects of using chemotherapy in women aged 45-80 y by lymph node and ER status; United States   N/A   Cost per LYS and QALYs   Direct medical care costs based on one hospital's charges and Medicare data; survival; physician-estimated utility   N/A   N/A   N/A   Hurny et al., 1992 (87)  Adjuvant therapy   RCT   Women receiving different numbers and timing of adjuvant chemotherapy cycles (3 vs. 6 and late reintroduction vs. not); Europe   854; 87% complete one QOL set; decrease to 70% over time   QOL   PACIS; LRS; bFs; POMS; HADS; translated into 11 languages   Self-administered   Yes   Unknown   Soukop et al., 1992 (207)  Adjuvant therapy   RCT   Women receiving chemotherapy; randomly assigned to receive ondansetron vs. metoclopramide; England   187   Emesis   Rates of emesis; severity of nausea   Self-administered   No   Yes   Clavel et al., 1993 (306)  Adjuvant therapy   RCT   Women receiving first course of chemotherapy and participating in 5 RCTs of ondansetron vs. placebo or metclopramide and alizapride   689   QOL; symptoms   RSCL; FLIC; FLIC emesis   Unknown   No   Unknown   Cox and Hirsch 1993 (307)  Adjuvant therapy   CEA   Comparison of ondansetron and metoclopramide in women receiving chemotherapy; United States   N/A   Costs per successfully treated patient (i.e., no emesis)   Average costs of drugs and medications to control adverse effects; time of providers caring for patients   N/A   N/A   N/A   Desch et al., 1993 (93)  Adjuvant therapy   CEA   Chemotherapy vs. no adjuvant therapy for women aged 60-80 y with ER-negative stage I cancer   N/A   Cost per LYS and QALYs; cost per active life expectancy   Direct medical care costs based on one hospital's charges and Medicare data; survival with the use of published data; physician-estimated utility   N/A   N/A   N/A   Mapelli et al., 1994 (308)  Adjuvant therapy   Costs of care in an RCT   Women with inflammatory breast cancer randomly assigned to receive high-dose FEC with or without lenograstim; Europe   120   Costs of care   Costs of direct medical resources consumed in the RCT   N/A   N/A   N/A   Clavel et al., 1995 (50)  Adjuvant therapy   RCT   Women receiving first course of chemotherapy and participating in RCT of ondansetron vs. alizapride to prevent emesis; France   254   QOL; symptoms   Symptom checklist; FLIC; FLIC emesis   Self-administered; in-person interview   No   Unknown   Barrenetxea et al., 1996 (309)  Adjuvant therapy   RCT   Women receiving mild emetogenic chemotherapy regimens; Spain   Unknown   QOL; emesis   FLIC; de novo tool   In-person interview   No   Unknown   Gelber et al., 1996 (310), 1998 (298)  Adjuvant therapy   RCT   Postmenopausal women aged ≥50 y with lymph node-positive disease; EBCTCG; standard chemotherapy plus tamoxifen vs. tamoxifen alone; Europe   3920   QOL   Qtwist; source of utility estimates not provided   N/A   N/A   Unknown   Hurny et al., 1996 (89)  Adjuvant therapy   RCT   Lymph node-positive women receiving CMF and booster cycles vs. CMF or CMF vs. tamoxifen; 10 languages; Europe   1248 premenopausal (85% response rate); 998 postmenopausal (83% response rate)   QOL   PACIS; bFs; LRS   Self-administered in clinic   No   Unknown   Lokich et al., 1996 (311)  Adjuvant therapy   Costs of care   Women receiving bolus vs. infusion administration of chemotherapy; United States   N/A   Cost per mode of administration   Charges including MD and/or clinic visit; laboratory; drug cost based on average wholesale price; cost of disposables; and pump rental fee   N/A   N/A   N/A   Longman et al., 1996 (312)  Adjuvant therapy   Cross-section   Women with mean age 55 y (range, 25-82 y) with all stages of disease; recent diagnosis and recurrences; United States   307   QOL   Side effects checklist; de Groot's Symptom Transition Scale; IARB; SCIWPR; Negative Affect Scale; IWB; Cantrill's Ladder   Unknown   Yes   Unknown   Messori et al., 1996 (313)  Adjuvant therapy   CEA using RCT data   CMF chemotherapy vs. none in women with lymph node-positive disease; Italy   388   Costs; LYS   Direct medical costs; survival “area under the curve” estimated by Gompertz function; assumes downstream costs are equal in both arms; no discounting   N/A   N/A   N/A   Hann et al., 1997 (314)  Adjuvant therapy; BMT   Case-control   Cancer center patients with BMT from 1990 to 1995; mean age 44 y (range, 32-57 y); United States   103; 86% response rate   QOL   MOS SF-36; KPS; MSAS   Mail survey   No   Unknown   Bernhard et al., 1998 (88); Hurny et al., 1996 (89)  Adjuvant therapy   RCT   Premenopausal women with lymph node-positive disease receiving CMF plus late CMF vs. CMF or postmenopausal women receiving tamoxifen vs. CMF (with or without delay booster); 9 languages; Europe   2687; subset response rate 82% for QOL   QOL   PACIS; LRS; bFs   Self-administered   No   Unknown   Carter et al., 1998 (315)  Adjuvant therapy   CEA   Treatment of early-stage breast cancer in the elderly; United States   N/A   Preference/utility; costs   Literature data; utilities were determined from the responses of health care professionals to a basic reference gamble   N/A   N/A   N/A   Fetting et al., 1998 (219)  Adjuvant therapy   RCT   Women with lymph node-positive, ER-negative disease randomly assigned to receive CAF in six cycles vs. 16 wk (16 wk includes methotrexate and vincristine); median age 47 y (range, 25-78 y); 15% black; United States   646; QOL data only available on 163; 87% complete all time points   QOL   BCQ   Unknown   No   Unknown   Frits et al., 1998 (316)  Adjuvant therapy   RCT   Women <55 y old with lymph node-positive cancer receiving tamoxifen plus standard chemotherapy vs. tamoxifen plus high-dose chemotherapy; controls without chemotherapy; The Netherlands   121   Cognitive impairment; QOL   Rey Auditory Verbal Learning Test; Complex Figure Test; digit span of WAIS; Trial Making; D2 test; Dutch aphasia test; Stroop Test; Fepsy Tests; EORTC-QLQ-C30; HSCL   In-person interview   No   Unknown   Bernhard et al., 1999 (317)  Adjuvant therapy   RCT   Women who failed prior adjuvant and/or palliative treatment with tamoxifen; randomly assigned to receive forestane vs. megestrol acetate; Switzerland   177; 83% response rate   QOL   De novo tools   Mail survey   No   Unknown   Day et al., 1999 (318)  Adjuvant therapy   Cohort   Women enrolled in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial   82% response rate   QOL   HRQL survey   Self-administered   No   Unknown   Fairclough et al., 1999 (82)  Adjuvant therapy   RCT   Women with hormone-reecptor-negative, lymph node-positive disease; United States   163; 87% response rate   QOL; quality-adjusted survival   Breast Chemotherapy Questionnaire (BCQ)   Self-administered   Yes   No   Gaston-Johansson et al., 1999 (319)  Adjuvant therapy   Cross-section   Women with stage II, III, or IV disease who were scheduled for autologous bone marrow/peripheral blood stem cell transplant; United States   127   Fatigue; pain; depression   Piper Fatigue Scale; MOS Short-form General Health Survey; Gaston-Johannsson Pain-O-Meter   Self-administered   No   Unknown   Hoerger et al., 1999 (320)  Adjuvant therapy   Costs of care   Women ≥45 y old using health care for cardiovascular disease, osteoporosis, breast cancer, or gynecologic cancers; United States   N/A   Costs; health care use   Data from Healthcare Cost and Utilization Project-3 (HCUP-3); national health care survey; discharge data; cost/charge ratios; Medicare fee schedule   N/A   N/A   N/A   Kurtz et al., 1999 (92)  Adjuvant therapy   Longitudinal cohort   Women >65 y old recruited for on-going study of 6 centers in Michigan; United States   383   QOL; comorbidity   MOS SF-36; Symptom Experience Scale   Unknown   No   Unknown   Macquart-Moulin et al., 1999 (321)  Adjuvant therapy   RCT   Women with <9 involved axillary lymph nodes; France   109; subset of 97 at follow-up   QOL; side effects   EORTC QLQ-C30; de novo tool   Self-administered   Yes   No   McKinna et al., 1999 (322)  Adjuvant therapy   RCT   Women with operable breast cancer and suitable for breast-conserving surgery (Jan. 1984-Dec. 1994) who were recommended a policy of observation to the lymphatic pathways; United Kingdom   291   Cancer-related morbidity   Case record review   N/A   N/A   N/A   Silber et al., 1998 (323)  Adjuvant therapy   CEA   Hypothetical cohort of women receiving chemotherapy; use of G-STF to prevent development of neutropenia; United States   N/A   Costs per LYS   Payor charges; survival with the use of published literature   N/A   N/A   N/A   Van Tiggelen et al., 1999 (324)  Adjuvant therapy   CEA   Comparison of oophorectomy with chemotherapy in premenopausal women; Belgium   N/A   Costs (assume equal effects based on one RCT)   Charges with the use of country-specified data   N/A   N/A   N/A   van Enckevort et al., 1999 (325)  Adjuant therapy   CEA   Women receiving chemotherapy, hormonal treatment, or both; The Netherlands   N/A   QALY; costs, preference/utility   Published studies (Jan 1980-Dec 1997)   N/A   N/A   N/A   Joly et al., 2000 (209)  Adjuvant therapy   RCT   Premenopausal women enrolled in a trial testing the efficacy of adjuvant CMF chemotherapy; lymph node negative; France   179; 68% response rate   QOL   EORTC QLQ-C30; EORTC QLQ-BR23   Mail survey   Yes   Unknown   Kramer et al., 2000 (326)  Adjuvant therapy   RCT   Women with baseline QL data from a trial of paclitaxel vs. doxorubicin as first-line chemotherapy; The Netherlands and Belgium   294; 64% response rate   QOL; survival effectiveness   EORTC QLQ-C30; RSCL   Self-administered   No   Unknown   Norum, 2000 (327)  Adjuvant therapy   CEA   Treatment with CMF; Norway   778 articles   QOL; preferences/utility; costs   MEDLINE English language literature with incorporated Norwegian Standard Act practice and cost data   N/A   N/A   N/A   Pandya et al., 2000 (328)  Adjuvant therapy   RCT   Postmenopausal patients experiencing at least one tamoxifen-induced hot flash per day; United States   194   QOL   Diary; de novo tools   Mail survey   No   No   Vrieling et al., 2000 (329)  Adjuvant therapy   RCT   Subset of women entered in the EORTC “boost vs. no-boost” trial of tumorectomy axillary dissection   1872   Cosmetic results   De novo tools   In-person interview   No   Unknown   View Large Appendix Table 6. Characteristics of studies of treatment of metastatic disease: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ABMT = autologous bone marrow transplantation; BMT = bone marrow transplant; CEA = cost-effectiveness analysis; CMF = combination chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil; ECOG = Eastern Cooperative Oncology Group; FAC = combination chemotherapy with 5-fluorouracil, doxorubicin, and cyclophosphamide; LYS = life years saved; MDs = medical doctors; N/A = not applicable; QALY = quality-adjusted life years; RCT = randomized controlled trial; RT = radiation therapy; SWOG = Southwest Oncology Group.   † SeeTable 3 for definitions of abbreviations of measures.   Biermann et al., 1991 (330)  Treatment of metastatic disease   Costs of care   Women with bone metastases; United States   457   LOS; costs per fracture; per hypercalcemia episode; per pain control; functioning   Hospital costs for fracture; OPD costs for RT and other care; chart note of inability to perform activities; chart review   N/A   N/A   N/A   van Holten-Verzantyoort et al., 1991 (210)  Treatment of metastatic disease   RCT   Women with osteolytic metastases with a life expectancy >6 mo; randomly assigned to receive supportive pamidronate treatment; The Netherlands   1179; 96% response rate   QOL   De novo tools   Mail survey and in-person interview   Yes   Unknown   Hillner et al., 1992 (331)  Treatment of metastatic disease   CEA   Hypothetical cohorts of women with metastatic disease treated with ABMT vs. standard chemotherapy; United States   N/A   Costs per LYS   Costs at one institution and Medicare costs; survival with the use of published literature   N/A   N/A   N/A   Koopmanschap et al., 1992 (332)  Treatment of metastatic disease   Costs of care   Care of women with advanced cancer over the course of disease; The Netherlands   N/A   Costs of advanced care; costs of home care; patient time costs; caregiver time costs   Costs of home care, hospital costs, nursing home costs   N/A   N/A   N/A   Kornblith et al., 1993 (333)  Treatment of metastatic disease   RCT   Women with stage IV cancer receiving megestrol acetate in 2 doses; average age 61 y; 88% white; United States   131   QOL   FLIC: MOS SF-36 and MHI; Body Image Subscale of Sexual Functioning Inventory; de novo side-effect index LRS   Mail survey; telephone interview   No   Unknown   Peters et al., 1994 (334)  Treatment of metastatic disease   Costs of care   Women undergoing high-dose chemotherapy with BMT and PBBCs; United States   110   Costs of episode of care   Hospital charges   N/A   N/A   N/A   Bertsch and Donaldson, 1995 (221)  Treatment of metastatic disease   RCT   Women with refractory advanced disease receiving either vinorelbine or melphalan; United States   179; Differential losses to follow-up; not analyzed by intention   QOL   Modified SWOG QOL; MOS SF-36; SDS; LRS   In-person interview   No   Unknown   Hayes et al., 1995 (335)  Treatment of metastatic   RCT   Women with metastatic disease randomly assigned to receive tamoxifen vs. toremifene in 2 doses; United States   648   QOL; symptoms   LRS; ECOG Analgesics Requirement Scale; pain assessment; ECOG Performance Status   Unknown   No   Unknown   Jones et al., 1995 (72)  Treatment of metastatic disease   RCT   Women with refractory advanced disease; median age 53 y (range, 29-83 y); 12% black; United States   183   QOL   Modified SWOG QOL   Self-administered   No   Unknown   McQuellon et al., 1995 (336)  Treatment of metastatic disease   Cross-section   Women with early-stage disease queried about preferences for treatment of metastatic cancer   15   Preferences   Modified TTO   In-person interview   No   Unknown   Hultborn et al., 1996 (337)  Treatment of metastatic disease   RCT (crossover at progression)   Women receiving methoxyprogesterone vs. aminoglutethimide plus cortisone; Sweden   200   QOL   NHP   Unknown   No   Unknown   Hultborn et al., 1996 (338)  Treatment of metastatic disease   RCT   Women with skeletal metastases; pamidronate vs. placebo; Sweden   404   Skeletal pain; performance status   VAS; performance status   Unknown   No   Unknown   Jonat et al., 1996 (339)  Treatment of metastatic disease   RCT   Postmenopausal women randomly assigned to receive arimidex or megase; Europe   378   QOL   RSCL; performance status   Self-administered   No   No   Launois et al., 1996 (340)  Treatment of metastatic disease   CEA using local data   Docetaxel vs. palitaxel vs. vinorelbine; France   N/A   Costs per Qaly   Direct costs in NHP; survival; utilities; utilities based on opinion of 20 nurses   Not stated   N/A   N/A   van Holten-Verzantvoort et al., 1996 341)  Treatment of metastatic disease   RCT   Women with skeletal metastases; pamidronate vs. placebo; The Netherlands   124   Skeletal pain; symptoms; mobility impairment   De novo tool   Self-administered   No   Unknown   Bates et al., 1997 (342)  Treatment of metastatic disease   CEA   Women with stage IIIB or IV disease receiving FAC and dexrazoxane (administered after 6 courses of FAC) vs. FAC alone; United States   N/A   Cost per cardiac event prevented; costs per LYS (note: costs of recurrence or any downstream events not included)   Medication costs and costs of cardiac events; survival with the use of data from 2 RCTs and expert opinion   N/A   N/A   N/A   Ramirez et al., 1998 (61)  Treatment of metastatic disease   Longitudinal cohort   Women with advanced metastatic disease receiving palliative chemotherapy; median age 58 y (range, 30-80 y); England   155; >90% response rate   QOL   RSCL; de novo items on overall well-being and perceived benefit of treatment   Interviewer administered   No   Unknown   Joensuu et al., 1998 (343)  Treatment of metastatic disease   RCT   Women <70 y old (average age 55 y) with metastases receiving epirubicin followed by mitomycin vs. CEF followed by VM; Finland   285   QOL   RSCL   Unknown   Yes   Unknown   Brown and Hutton, 1998 (344)  Treatment of metastatic disease   CEA   Docetaxel vs. paclitaxel for patients with advanced metastatic disease; England   N/A   Costs; QALYs   Direct costs estimated by MDs and Medicare; nurse-assessed utility; data from published literature   N/A   N/A   N/A   Bull et al., 1991 (222)  Treatment of recurrence   Longitudinal cohort within RCT   Women with recurrent disease; <70 y old; stages I-III; Italy   1320; subset of 176 with recurrence   QOL; satisfaction; symptoms   25 items used in Italian for 6 domains; LRS for satisfaction; symptom checklist   Mail survey   No   Unknown   Cobleigh et al., 1999 (345)  Treatment of metastatic disease   RCT   Women with HER2-over-expressing disease after one or two chemotherapy treatments; United States, Canada, Belguim, France, Germany, United Kingdom, and Australia   222; subset of 154 assessed for QOL   QOL   EORTC QLQ-C30   In-person interview   No   Unknown   Cotton et al., 1999 (346)  Treatment of metastatic disease   RCT   Women diagnosed with invasive disease within the last 18 mo or recurrence who were participating in a larger study designed to compare the efficacy of two psychosocial support programs; United States   142   Spiritual well-being; QOL; psychologic adjustment   FACIT-B; FACTSP; Mini-Mental Adjustment to Cancer; Principles of Living Survey   Self-administered   No   Unknown   Harper-Wynne et al., 1999 (208)  Treatment of metastatic disease   RCT   Women with locally advanced or metastatic disease; concluded adjuvant therapy at least 2 y before; randomly assigned to receive CMF vs. MM; England   116   QOL; satisfaction; symptoms   HADS; RSCL; patient satisfaction questions   In-person interview   No   Noted to be low   Hoerger et al., 1999 (320)  Treatment of metastatic disease   Costs of care   Women ≥45 y old using health care for cardiovascular disease, osteoporosis, breast cancer, or gynecologic cancers; United States   N/A   Costs; health care use   Data from Health care Cost and Utilization Project-3 (HCUP-3); national health care survey; discharge data—cost/charge ratios; Medicare fee schedule   N/A   N/A   N/A   Hultborn et al., 1999 (347)  Treatment of metastatic disease   RCT   Women with skeletal metastases not previously treated with bisphosphates randomly assigned to receive pamidronate vs. placebo; Sweden and Norway   404   Pain; skeletal-related events   Visual Analogue Scales; analgesic consumption   In-person interview   No   Unknown   Kristensen et al. 1999 (348)  Treatment of metastatic disease   RCT   Women who received first-line systemic antineoplastic disease vs. placebo; bone involvement for <6 mo or untreated; Denmark   100   QOL   EORTC QLQ-C30; HADS   In-person interview   No   Unknown   Leung et al., 1999 (349)  Treatment of metastatic disease   CEA   Women who are anthracycline resistant who had received paclitaxel, docetaxel, or vinorelbine during the past ≥2 y   Unknown   Preferences/utility; cost per quality-adjusted progression-free year   Chart review   N/A   N/A   N/A   Nabholtz et al., 1999 (350), 1997 (351)  Treatment of metastatic disease   RCT   Women ≥ 18 y old with progressive metastatic disease; randomly assigned to receive docetaxel or mitomycin and vinblastine; Canada and Europe   392   QOL (global and physical functions)   EORTC-QLQ-C30   Self-administered   No   Unknown   Nuijten et al., 1999 (352)  Treatment of metastatic disease   CEA   Hypothetical cohort of postmenopausal women recruited for the AR/BC2 clinical trial treated with letrozole; United Kingdom   N/A   Preference/utility; costs   Based on clinical trial results showing the advantage of letrozole in terms of time to disease progression and duration of response   N/A   N/A   N/A   Osoba and Burchmore, 1999 (353)  Treatment of metastatic disease   RCT   Women with progressive HER2-overexpressing metastatic disease treated with Trasuzumab vs. placebo; Canada   222 for phase II and 469 for phase III   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Burgess et al., 2000 (354)  Treatment of metastatic disease   RCT   Women who had detected disease symptoms themselves; interviewed 5 mo after diagnosis; United Kingdom   196   Presence of adverse life events and difficulties; psychiatric morbidity   LEDS; SCID; DSM III-R diagnostic criteria   In-person interview   No   Unknown   Geels et al., 2000 (355)  Treatment of metastatic disease   Cohort   Women with metastatic disease; randomly assigned to receive intravenous doxorubicin or doxorubicin with vinorelbine; Canada   300; 96% response rate   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Hakamies-Blomqvist et al., 2000 (356)  Treatment of metastatic disease   RCT   Women with metastatic disease; randomly assigned to receive docetaxel vs. sequential methotrexate and 5-fluorouracil (Dec. 1994 to Oct. 1997); Scandinavia   283   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Hillner et al., 2000 (357)  Treatment of metastatic disease   CEA   Hypothetical group of women with osteolytic bone metastases receiving pamidronate; United States   N/A   Preference/utility; costs   Database of costs at the Massey Cancer Center; based on Aredia Breast Cancer Study Group trials   N/A   N/A   N/A   Kaufmann et al., 2000 (358)  Treatment of metastatic disease   RCT   Postmenopausal women with disease progression/relapse during TAM treatment and at least one lytic bony lesion; randomly assigned to receive exemestane vs. megestrol acetate; 19 countries   769   QOL; tolerability   Unknown   Self-administered   No   Unknown   Kramer et al., 2000 (359)  Treatment of metastatic disease   RCT   Women with metastatic disease; randomly assigned to receive paclitaxel vs. doxorubicin as first-line chemotherapy; The Netherlands, Denmark, and Belgium   294; subset of 187 (64%) for QOL analysis   QOL   EORTC QLQ-C30; RSCL   Self-administered   No   Unknown   Lipton et al., 2000 (360)  Treatment of metastatic disease   RCT   Women with osteolytic bone metastases receiving pamidronate; United States, Canada, Australia, and New Zealand   754   Skeletal complications   Biological markers   N/A   No   Unknown   Norris et al., 2000 (361)  Treatment of metastatic disease   RCT   National Cancer Institute of Canada Clinical Trials Group Study MA8; patients 18-75 y old; life expectancy >16 wk; randomly assigned to receive vinorelbine and doxorubicin vs. doxorubicin; Canada   303   QOL   EORTC QLQ-C30; de novo tool   In-person interview   No   Unknown   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ABMT = autologous bone marrow transplantation; BMT = bone marrow transplant; CEA = cost-effectiveness analysis; CMF = combination chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil; ECOG = Eastern Cooperative Oncology Group; FAC = combination chemotherapy with 5-fluorouracil, doxorubicin, and cyclophosphamide; LYS = life years saved; MDs = medical doctors; N/A = not applicable; QALY = quality-adjusted life years; RCT = randomized controlled trial; RT = radiation therapy; SWOG = Southwest Oncology Group.   † SeeTable 3 for definitions of abbreviations of measures.   Biermann et al., 1991 (330)  Treatment of metastatic disease   Costs of care   Women with bone metastases; United States   457   LOS; costs per fracture; per hypercalcemia episode; per pain control; functioning   Hospital costs for fracture; OPD costs for RT and other care; chart note of inability to perform activities; chart review   N/A   N/A   N/A   van Holten-Verzantyoort et al., 1991 (210)  Treatment of metastatic disease   RCT   Women with osteolytic metastases with a life expectancy >6 mo; randomly assigned to receive supportive pamidronate treatment; The Netherlands   1179; 96% response rate   QOL   De novo tools   Mail survey and in-person interview   Yes   Unknown   Hillner et al., 1992 (331)  Treatment of metastatic disease   CEA   Hypothetical cohorts of women with metastatic disease treated with ABMT vs. standard chemotherapy; United States   N/A   Costs per LYS   Costs at one institution and Medicare costs; survival with the use of published literature   N/A   N/A   N/A   Koopmanschap et al., 1992 (332)  Treatment of metastatic disease   Costs of care   Care of women with advanced cancer over the course of disease; The Netherlands   N/A   Costs of advanced care; costs of home care; patient time costs; caregiver time costs   Costs of home care, hospital costs, nursing home costs   N/A   N/A   N/A   Kornblith et al., 1993 (333)  Treatment of metastatic disease   RCT   Women with stage IV cancer receiving megestrol acetate in 2 doses; average age 61 y; 88% white; United States   131   QOL   FLIC: MOS SF-36 and MHI; Body Image Subscale of Sexual Functioning Inventory; de novo side-effect index LRS   Mail survey; telephone interview   No   Unknown   Peters et al., 1994 (334)  Treatment of metastatic disease   Costs of care   Women undergoing high-dose chemotherapy with BMT and PBBCs; United States   110   Costs of episode of care   Hospital charges   N/A   N/A   N/A   Bertsch and Donaldson, 1995 (221)  Treatment of metastatic disease   RCT   Women with refractory advanced disease receiving either vinorelbine or melphalan; United States   179; Differential losses to follow-up; not analyzed by intention   QOL   Modified SWOG QOL; MOS SF-36; SDS; LRS   In-person interview   No   Unknown   Hayes et al., 1995 (335)  Treatment of metastatic   RCT   Women with metastatic disease randomly assigned to receive tamoxifen vs. toremifene in 2 doses; United States   648   QOL; symptoms   LRS; ECOG Analgesics Requirement Scale; pain assessment; ECOG Performance Status   Unknown   No   Unknown   Jones et al., 1995 (72)  Treatment of metastatic disease   RCT   Women with refractory advanced disease; median age 53 y (range, 29-83 y); 12% black; United States   183   QOL   Modified SWOG QOL   Self-administered   No   Unknown   McQuellon et al., 1995 (336)  Treatment of metastatic disease   Cross-section   Women with early-stage disease queried about preferences for treatment of metastatic cancer   15   Preferences   Modified TTO   In-person interview   No   Unknown   Hultborn et al., 1996 (337)  Treatment of metastatic disease   RCT (crossover at progression)   Women receiving methoxyprogesterone vs. aminoglutethimide plus cortisone; Sweden   200   QOL   NHP   Unknown   No   Unknown   Hultborn et al., 1996 (338)  Treatment of metastatic disease   RCT   Women with skeletal metastases; pamidronate vs. placebo; Sweden   404   Skeletal pain; performance status   VAS; performance status   Unknown   No   Unknown   Jonat et al., 1996 (339)  Treatment of metastatic disease   RCT   Postmenopausal women randomly assigned to receive arimidex or megase; Europe   378   QOL   RSCL; performance status   Self-administered   No   No   Launois et al., 1996 (340)  Treatment of metastatic disease   CEA using local data   Docetaxel vs. palitaxel vs. vinorelbine; France   N/A   Costs per Qaly   Direct costs in NHP; survival; utilities; utilities based on opinion of 20 nurses   Not stated   N/A   N/A   van Holten-Verzantvoort et al., 1996 341)  Treatment of metastatic disease   RCT   Women with skeletal metastases; pamidronate vs. placebo; The Netherlands   124   Skeletal pain; symptoms; mobility impairment   De novo tool   Self-administered   No   Unknown   Bates et al., 1997 (342)  Treatment of metastatic disease   CEA   Women with stage IIIB or IV disease receiving FAC and dexrazoxane (administered after 6 courses of FAC) vs. FAC alone; United States   N/A   Cost per cardiac event prevented; costs per LYS (note: costs of recurrence or any downstream events not included)   Medication costs and costs of cardiac events; survival with the use of data from 2 RCTs and expert opinion   N/A   N/A   N/A   Ramirez et al., 1998 (61)  Treatment of metastatic disease   Longitudinal cohort   Women with advanced metastatic disease receiving palliative chemotherapy; median age 58 y (range, 30-80 y); England   155; >90% response rate   QOL   RSCL; de novo items on overall well-being and perceived benefit of treatment   Interviewer administered   No   Unknown   Joensuu et al., 1998 (343)  Treatment of metastatic disease   RCT   Women <70 y old (average age 55 y) with metastases receiving epirubicin followed by mitomycin vs. CEF followed by VM; Finland   285   QOL   RSCL   Unknown   Yes   Unknown   Brown and Hutton, 1998 (344)  Treatment of metastatic disease   CEA   Docetaxel vs. paclitaxel for patients with advanced metastatic disease; England   N/A   Costs; QALYs   Direct costs estimated by MDs and Medicare; nurse-assessed utility; data from published literature   N/A   N/A   N/A   Bull et al., 1991 (222)  Treatment of recurrence   Longitudinal cohort within RCT   Women with recurrent disease; <70 y old; stages I-III; Italy   1320; subset of 176 with recurrence   QOL; satisfaction; symptoms   25 items used in Italian for 6 domains; LRS for satisfaction; symptom checklist   Mail survey   No   Unknown   Cobleigh et al., 1999 (345)  Treatment of metastatic disease   RCT   Women with HER2-over-expressing disease after one or two chemotherapy treatments; United States, Canada, Belguim, France, Germany, United Kingdom, and Australia   222; subset of 154 assessed for QOL   QOL   EORTC QLQ-C30   In-person interview   No   Unknown   Cotton et al., 1999 (346)  Treatment of metastatic disease   RCT   Women diagnosed with invasive disease within the last 18 mo or recurrence who were participating in a larger study designed to compare the efficacy of two psychosocial support programs; United States   142   Spiritual well-being; QOL; psychologic adjustment   FACIT-B; FACTSP; Mini-Mental Adjustment to Cancer; Principles of Living Survey   Self-administered   No   Unknown   Harper-Wynne et al., 1999 (208)  Treatment of metastatic disease   RCT   Women with locally advanced or metastatic disease; concluded adjuvant therapy at least 2 y before; randomly assigned to receive CMF vs. MM; England   116   QOL; satisfaction; symptoms   HADS; RSCL; patient satisfaction questions   In-person interview   No   Noted to be low   Hoerger et al., 1999 (320)  Treatment of metastatic disease   Costs of care   Women ≥45 y old using health care for cardiovascular disease, osteoporosis, breast cancer, or gynecologic cancers; United States   N/A   Costs; health care use   Data from Health care Cost and Utilization Project-3 (HCUP-3); national health care survey; discharge data—cost/charge ratios; Medicare fee schedule   N/A   N/A   N/A   Hultborn et al., 1999 (347)  Treatment of metastatic disease   RCT   Women with skeletal metastases not previously treated with bisphosphates randomly assigned to receive pamidronate vs. placebo; Sweden and Norway   404   Pain; skeletal-related events   Visual Analogue Scales; analgesic consumption   In-person interview   No   Unknown   Kristensen et al. 1999 (348)  Treatment of metastatic disease   RCT   Women who received first-line systemic antineoplastic disease vs. placebo; bone involvement for <6 mo or untreated; Denmark   100   QOL   EORTC QLQ-C30; HADS   In-person interview   No   Unknown   Leung et al., 1999 (349)  Treatment of metastatic disease   CEA   Women who are anthracycline resistant who had received paclitaxel, docetaxel, or vinorelbine during the past ≥2 y   Unknown   Preferences/utility; cost per quality-adjusted progression-free year   Chart review   N/A   N/A   N/A   Nabholtz et al., 1999 (350), 1997 (351)  Treatment of metastatic disease   RCT   Women ≥ 18 y old with progressive metastatic disease; randomly assigned to receive docetaxel or mitomycin and vinblastine; Canada and Europe   392   QOL (global and physical functions)   EORTC-QLQ-C30   Self-administered   No   Unknown   Nuijten et al., 1999 (352)  Treatment of metastatic disease   CEA   Hypothetical cohort of postmenopausal women recruited for the AR/BC2 clinical trial treated with letrozole; United Kingdom   N/A   Preference/utility; costs   Based on clinical trial results showing the advantage of letrozole in terms of time to disease progression and duration of response   N/A   N/A   N/A   Osoba and Burchmore, 1999 (353)  Treatment of metastatic disease   RCT   Women with progressive HER2-overexpressing metastatic disease treated with Trasuzumab vs. placebo; Canada   222 for phase II and 469 for phase III   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Burgess et al., 2000 (354)  Treatment of metastatic disease   RCT   Women who had detected disease symptoms themselves; interviewed 5 mo after diagnosis; United Kingdom   196   Presence of adverse life events and difficulties; psychiatric morbidity   LEDS; SCID; DSM III-R diagnostic criteria   In-person interview   No   Unknown   Geels et al., 2000 (355)  Treatment of metastatic disease   Cohort   Women with metastatic disease; randomly assigned to receive intravenous doxorubicin or doxorubicin with vinorelbine; Canada   300; 96% response rate   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Hakamies-Blomqvist et al., 2000 (356)  Treatment of metastatic disease   RCT   Women with metastatic disease; randomly assigned to receive docetaxel vs. sequential methotrexate and 5-fluorouracil (Dec. 1994 to Oct. 1997); Scandinavia   283   QOL   EORTC QLQ-C30   Self-administered   No   Unknown   Hillner et al., 2000 (357)  Treatment of metastatic disease   CEA   Hypothetical group of women with osteolytic bone metastases receiving pamidronate; United States   N/A   Preference/utility; costs   Database of costs at the Massey Cancer Center; based on Aredia Breast Cancer Study Group trials   N/A   N/A   N/A   Kaufmann et al., 2000 (358)  Treatment of metastatic disease   RCT   Postmenopausal women with disease progression/relapse during TAM treatment and at least one lytic bony lesion; randomly assigned to receive exemestane vs. megestrol acetate; 19 countries   769   QOL; tolerability   Unknown   Self-administered   No   Unknown   Kramer et al., 2000 (359)  Treatment of metastatic disease   RCT   Women with metastatic disease; randomly assigned to receive paclitaxel vs. doxorubicin as first-line chemotherapy; The Netherlands, Denmark, and Belgium   294; subset of 187 (64%) for QOL analysis   QOL   EORTC QLQ-C30; RSCL   Self-administered   No   Unknown   Lipton et al., 2000 (360)  Treatment of metastatic disease   RCT   Women with osteolytic bone metastases receiving pamidronate; United States, Canada, Australia, and New Zealand   754   Skeletal complications   Biological markers   N/A   No   Unknown   Norris et al., 2000 (361)  Treatment of metastatic disease   RCT   National Cancer Institute of Canada Clinical Trials Group Study MA8; patients 18-75 y old; life expectancy >16 wk; randomly assigned to receive vinorelbine and doxorubicin vs. doxorubicin; Canada   303   QOL   EORTC QLQ-C30; de novo tool   In-person interview   No   Unknown   View Large Appendix Table 7. Characteristics of studies on the outcomes of breast cancer survivors: January 1, 1990 through December 31, 2000* Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ADLs = activities of daily living; BCS = breast conserving surgery; FDA = Food and Drug Administration; MD = medical doctor; N/A = not available; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy; SEER = Surveillance, Epidemiology, and End Results.   † SeeTable 3 for definitions of abbreviations of measures.   Marks et al., 1990 (65)  Survivor   Longitudinal cohort   Women with local- and regional-stage disease; mean age 59 y (range, 40-84 y); 1 y after treatment; population-based registry; 15% black; United States   274; 77% response rate   Effect of health on functioning; perceived stress; uncertainty and control; mental health; sexual function; comorbidity symptoms   De novo tools; HSCL; Andrews and Withey QOL; Caplan Role and Emotional Function; Bradburn's Positive Affect Scale; Rosenberg's Scale of Self-Esteem; Berkman's Social Network Index; House Social Support   Self- and interviewer administered   Yes   Unknown   Levy et al., 1992 (220)  Survivor   Longitudinal cohort   Women undergoing MST or BCS; assessed 3 and 15 mo after surgery; average age 51 y; United States   129; 95% response rate but approximately 50% lost to follow-up   QOL   POMS; KPS; MPSSQ   Unknown   No   Unknown   Hannisdal et al., 1993 (362)  Survivor   Costs of care   Cohort of women treated for stage I or II disease followed-up for 8 y; Norway   430   Costs of follow-up per detected relapse; survival   Costs; relapse rates; survival   N/A   N/A   N/A   Holli and Hakama, 1993 (363)  Survivor   Retrospective cohort   Women diagnosed between 1977 and 1980; residing in one district and reported to national cancer registry; followed for 5 y; disease stage not stated; Finland   551   QOL   Sick leave; KPS; notes on QOL; medical record review   N/A   No   Unknown   Bloom and Kessler, 1994 (62)  Survivor   Longitudinal cohort   Women after surgical treatment for early breast cancer, gallbladder disease, or benign breast disease or no surgery; enrolled in Psychological Aspects of Breast Cancer Study; average age 52.5 y (range, 30-69 y); 9.6% black, 3% Asian, and 3% Hispanic; all English speaking; United States   145   Perceived social support; stigma; role functioning   Perceived Social Support Scale (unpublished tool); Social Role Function and Daily Activities Scale; Family Interaction Scale from SIP; Social Health Index; MOS PF   Self-administered survey; in-person interview; 5-meeting speech sample   No   Unknown   GIVIO, 1994 (364)  Survivor   RCT   Women <70 y old with stage I, II, or III disease, randomly assigned to low- vs. high-intensity follow-up surveillance over 5-6 years; Italy   1320   QOL; satisfaction with care   25 items modified from FLIC, SIP, POMS, and CARES   Self-administered   Yes   Unknown   Mor et al., 1994 (365)  Survivor   Cohort   Women enrolled in two RCTs using similar protocols and measures; aged >24 y; state I and II disease; United States   262   QOL   MHI; Katz ADL and IADL; de novo financial impact   Telephone interview   No   Unknown   Roberts et al., 1994 (211)  Survivor   Cross-section   Women aged 29-82 y 6 mo after surgery; disease stage not stated; United States   100   Patient-MD communication; psychologic distress in 9 domains   CDIS; SCL-90-R; MD-rated health; Northhouse social support   Telephone interview; bias: PI interviewer   Yes   Unknown   Coleman et al., 1995 (366)  Survivor   Cross-section   Women aged 40-69 y with silicone implants reported to FDA as having problems after mastectomies; 97% white; United States   120   ADL; role relations; coping   Open-ended questions   Telephone interviews   N/A   Unknown   Couzi et al., 1995 (63)  Survivor   Cross-section   Postmenopausal women diagnosed with in situ or invasive locoregional breast car cer in the years 1988-1992; mean age 55 y (range, 41-65 y); 14% black; United States   190; 77% response rate   QOL; symptoms   De novo tool   Mail survey   No   Yes   German Breast Cancer Study Group, 1995 (367)  Survivor   Longitudinal cohort   Women with stage I disease receiving MST or BCS plus RT; Germany   1036; QOL available for 703   QOL   Unknown   Self-administered   No   Unknown   Liberati, 1995 (90)  Survivor   RCT   Women treated for stage I, II, or III unilateral primary breast cancer were randomly assigned to intensive surveillance vs. less intensive surveillance; <70 y old; Italy   1320; 639 with 5-y data   Overall QOL; perception of health, emotions, body image, social function, symptoms, satisfaction   De novo tool in Italian   Self-administered   Yes   Yes   Paradiso et al., 1995 (368)  Survivor   Cross-section   Representative sample of specialists, general practitioners, and patients involved in the management of follow-up practice for disease; mean age 58 y (range, 29-83 y); Italy   173; 61% response rate   Emotional response to follow-up; satisfaction   De novo tools   Mail survey   No   N/A   Schover et al., 1995 (215)  Survivor   Cross-section   Women who had partial mastectomy or had immediate breast reconstruction after mastectomy; average age 54 y; mean of 4 y after surgery; United States   218; 44% response rate   QOL and satisfaction   PAIS-SR; BES; Dyadic Adjustment Inventory; Sexual History Form   Mail survey   No   Unknown   Tasmuth et al., 1995 (369)  Survivor   Cross-section   Women who had undergone MRM or BCT; 4-7 y after surgery; ages 29-93 y; Finland   467; 92% response rate   Chronic pain   McGill; LRS   Mail survey   No   Unknown   Dow et al., 1996 (216)  Survivor   Cross-section   Women who are disease free; members of the National Coalition for Cancer Survivorship; mean age 50.9 y (range, 27-77 y); 93% white; United States   294; 43% response rate   QOL   FACT-G; QOL-CS   Mail survey   No   Unknown   Ganz et al., 1996 (85)  Survivor   Cohort   Women who had been interviewed during the 1st year after primary treatment; follow-up at 2-3 y   227; 77% response rate   QOL; psychosocial concerns   FLIC; CARES; MOS SF-36; GHQ   Mail survey; in-person interview   No   Unknown   Grunfeld et al., 1996 (370)  Survivor   RCT   Women with stage I, II or III disease at diagnosis; followed-up for recurrence at hospital vs. primary care sites; mean age 61 y; England   296; 67% response rate   QOL   MOS SF-36; EORTC-QLQ-C30; HADS   Mail survey   No   Unknown   Satariano and DeLorenze, 1996 (64)  Survivor   Longitudinal cohort   Employed women; 3 mo after being diagnosed; ages 40-84 y; reported to a SEER registry; 16% black; United States   296   Return to work   De novo tools   In-person interview   N/A   Unknown   Grunfeld et al., 1996 (370); Adewuyi-Dalton et al., 1998 (371)  Survivor   Cross-section   Women receiving follow-up care in one arm of RCT (primary care); enrolled in an RCT of primary care follow-up; England   109   Satisfaction   Qualitative interview   In-person interview   N/A   Unknown   Ashbury et al., 1998 (198)  Survivor   Case-control   Women who received services from Reach for Recovery vs. control subjects in other areas; Canada   192; 69% response rate; QOL data for 175/192   QOL; satisfaction   FLIC; FACT; Duke-UNC Functional Social Support Questionnaire; open-ended satisfaction items   Interviewer administered for case subjects; mail for control subjects   Yes   Unknown   Gulliford et al., 1997 (372)  Survivor   RCT   Women at two clinics over a 24-mo period; randomly assigned to conventional schedule of clinic visits vs. visits only after mammography; relapse-free for median of 16 mo after treatment; England   196   QOL; satisfaction; use of telephone call-in line; time and costs of follow-up   Medical Research Council QOL   Mail survey   No   Unknown   Lee, 1997 (199)  Survivor   Cross-section   Women who were up to 14 y after MST; Reach for Recovery volunteers; United States   100; 75% response rate   QOL   Ferrans and Powers QLI   Mail survey   Yes   Unknown   Poulsen et al., 1997 (373)  Survivor   RCT   Women <69 y old receiving MST vs. BCS; Denmark   184; 39.6% response rate   QOL; satisfaction   LRS; STAI   Interviewer administered   No   Unknown   Tate et al., 1997 (374)  Survivor   Cross-section   Women with disabilities and women with breast cancer; United States   216   QOL and life satisfaction   FLIC; FACT; FACT SP; SWLS   Unknown   No   Unknown   Bloom et al., 1998 (68)  Survivor   Cross-section   Women ≤50 y old (range, 21-51 y); 30% black; 6 mo after diagnosis; United States   336   QOL; MD-patient communication; body image   Illness Intrusiveness Scale; Cancer Problem Scale; SDS; Emotional Support Scale; MOS SF-36; Rosenberg's Scale of Self-Esteem   Interviewer administered in patient's home       Carpenter et al., 1998 (375,376)  Survivor   Cross-section   Women who are disease free, >3 mo after treatment; postmenopausal; 58 y (range, 36-83 y); stage 0-III; 96% white; United States   136; 114 postmenopausal   Pain; satisfaction with pain therapy; symptoms (hot flashes) and QOL   Wisconsin Brief Pain Inventory; de novo items; MOS SF12, 3 questions on hot flashes; SF12;   Phone interview   No   Unknown   Curran et al., 1998 (200)  Survivor   RCT   Women aged 23-70 y with stage I or II cancer receiving MRM vs. BCS 2 y after surgery; Europe   278   QOL; satisfaction with cosmetic result; fear of recurrence   Avery QOL   Unknown   Yes   Unknown   Dorval et al., 1998 (202)  Survivor   Longitudinal cohort   Women treated for local and regional disease; 8 y after treatment; Canada   124; 96% response rate   QOL; psychologic distress   PSI; arm problems; hospital stays; LWMAT; LES   Telephone interview   Yes   Unknown   Dorval et al., 1998 (201)  Survivor   Case-Control   Women treated for local and regional disease; 8 y after diagnosis (disease-free or with recurrences); randomly selected community control subjects; Canada   386; 96% response rate in case subjects and 61% response rate in control subjects   QOL   Number of health problems requiring hospitalization; arm problems; de novo functional status; PSI; MOS Social Support Scale; LWMAT; LES   Telephone interview   Yes   Unknown   Ferrell et al., 1998 (218)  Survivor   Cross-section   Women who are disease free; stratified by 3 age groups: <40 y old, 40-60 y old, and >60 y old; United States   298; 40% response rate   QOL; pain   QOL-BC; BPI   Mail survey   No   Unknown   Frazer et al., 1998 (203)  Survivor   Cross-section   Women seen at cancer center; average age 61 y; United States   120; 57% response rate   QOL   HSQ   Mail survey   Yes   Unknwon   Ganz et al., 1998 (67,204)  Survivor   Cross-section   Women who are disease-free; mean age 56 y (range, 31-88 y) with stage 0, I, or II disease surveyed 1-5 y after diagnosis in 2 regions; 11%-17% black per region; 1%-6% Hispanic; United States   864   QOL; sexual function   MOS SF-36; CES-D; BCPT Symptom Checklist; WSFQ; CARES   Mail survey   Yes   Unknown   Jahkola, 1998 (377)  Survivor   Cross-section   Women treated with MST or BCS; 3-8 y after surgery; mean age 60 y (range, 33-84 y); Finland   146   QOL; satisfaction   De novo tool   Mail survey   N/A   N/A   Lindley et al., 1998 (66)  Survivor   Cross-section   Women with early-stage cancer who were disease free 2-5 y after adjuvant treatment; average age 54 y (range, 29-86 y); 87.1% white; United States   120; 86 completed all data   QOL; preferences   FLIC; SDS; MOS SF-36; de novo sexuality; modified TTO preferences   Telephone interview   No   Unknown   Tomiak et al., 1998 (217)  Survivor   Costs of care   Costs of following-up women with stage I or II disease; Canada   130 MDs; 44% response rate   Follow-up costs per patient   Unit costs in the NHP   Mail survey   N/A   N/A   van Harten et al., 1998 (205)  Survivor   Cross-section   Women who were patients of 4 oncologists; The Netherlands   103; 60% response rate   QOL   CARES-SF; RSCL; QLQ; EORTC; comorbidity   Mail survey   Yes   Unknown   Velanovich and Szymanski, 1999 (378)  Survivor   Cross-section   Patients of one MD at a cancer center; >6 mo to 4 y after surgery; United States   101   Lymphedema; QOL   MOS SF-36   Self-administered in MD's office   No   Unknown   Andersen and Urban, 1999 (379)  Survivor   Cross-section   Women who are disease free; 50-85 y old; in rural and suburban communities   292   QOL   MOS SF-36; Lerman Cancer Worry Scale; de novo tool   Telephone interview   No   Unknown   Ashing-Giwa et al., 1999 (70)  Survivor   Cross-section   Women 6-8 y after surgery; age range; 32-90 y; 42% black; United States   278; 54% overall response rate; 44% in blacks; 65% in whites   QOL   MOS SF-36; CARES-SF; Ladder; Urban Life Stress Scale; ADQ   Mail survey   No   Unknown   Carpenter and Andrykowski, 1999 (380)  Survivor   Cross-section   Women who are disease-free; ≥18 y old 3 mo after treatment of 1st diagnosis; United States   114; 79% response rate   QOL; menopausal symptoms   Massachusetts Women's Health Study Questionnaire; Blatt Menopausal Index; SF-12 Health Survey   Telephone interview   Yes   Unknown   Fogarty et al., 1999 (213)  Survivor   RCT   Women diagnosed at least 6 mo before and presently disease-free or without cancer but an average of 3 friends/relatives with history of breast cancer   210   Patient anxiety; physician compassion   STAI; de novo tools   Mail survey   Yes   Unknown   Ganz et al., 1999 (81)  Survivor   Cross-section   Women who were in a partnered relationship and sexually active within the past 6 mo in Los Angeles, CA, and Washington, DC, with a diagnosis of stage, 0, I, or II disease and who completed local and adjuvant therapy; United States   1134   Sexual health   CARES Body Image Subscale; Sexual Functioning Summary Scale, Sexual Interest and Dysfunction Subscale; BCPT Symptom Checklist; Revised DAS; RAND Health Survey; WSFQ   Mail survey   No   Unknown   Grunfeld et al., 1999 (214)  Survivor   RCT   Women who received follow-up care in primary care vs. specialist care; United Kingdom   296   Patient satisfaction   De novo tools   Self-administered   Yes   Unknown   Spenser et al., 1999 (69)  Survivor   Cross-section   Women 1 y after treatment; stage 0, I, or II disease; approximately 10% black and 20% Hispanic; United States   223; 80% response rate   QOL   De novo tool on patient concerns; POMS; CES-D; Andrews and Withey adjustment; PAIS-SR; de novo body image; SIP (English and Spanish translations)   Mail survey   Yes   Unknown   Bower et al., 2000 (381)  Survivor   RCT   Women treated for early resectable disease; not receiving any treatment besides tamoxifen; in 2 large metropolitan areas; United States   1957   QOL; level of fatigue   MOS SF-36; CES-D; BCPT Symptom Checklist; MOS Sleep Scale   Mail survey   No   Unknown   Demark-Wahnefried et al., 2000 (382)  Survivor   Cross-section   Women who were identified by the Duke Cancer Database as being diagnosed with early-stage disease but who are now disease free   1666; 58% response rate   Current health behaviors; readiness to pursue life-style changes   Eating Patterns Questionnaire; de novo tools   Mail survey   No   Unknown   Wilson et al., 2000 (48)  Survivor   Cohort   Women who are disease free; in rural communities; during a 5-mo period in 1996; United States   128   Survivors' representations; positive coping strategies; negative coping strategies   Focus group   In-person interview   No   Unknown   Author, y (reference No.)   Phase of care   Study design   Setting and population   Sample size   Outcomes   Measures†   Mode of assessment   Report of reliability   Power   *ADLs = activities of daily living; BCS = breast conserving surgery; FDA = Food and Drug Administration; MD = medical doctor; N/A = not available; QOL = quality of life; RCT = randomized controlled trial; RT = radiation therapy; SEER = Surveillance, Epidemiology, and End Results.   † SeeTable 3 for definitions of abbreviations of measures.   Marks et al., 1990 (65)  Survivor   Longitudinal cohort   Women with local- and regional-stage disease; mean age 59 y (range, 40-84 y); 1 y after treatment; population-based registry; 15% black; United States   274; 77% response rate   Effect of health on functioning; perceived stress; uncertainty and control; mental health; sexual function; comorbidity symptoms   De novo tools; HSCL; Andrews and Withey QOL; Caplan Role and Emotional Function; Bradburn's Positive Affect Scale; Rosenberg's Scale of Self-Esteem; Berkman's Social Network Index; House Social Support   Self- and interviewer administered   Yes   Unknown   Levy et al., 1992 (220)  Survivor   Longitudinal cohort   Women undergoing MST or BCS; assessed 3 and 15 mo after surgery; average age 51 y; United States   129; 95% response rate but approximately 50% lost to follow-up   QOL   POMS; KPS; MPSSQ   Unknown   No   Unknown   Hannisdal et al., 1993 (362)  Survivor   Costs of care   Cohort of women treated for stage I or II disease followed-up for 8 y; Norway   430   Costs of follow-up per detected relapse; survival   Costs; relapse rates; survival   N/A   N/A   N/A   Holli and Hakama, 1993 (363)  Survivor   Retrospective cohort   Women diagnosed between 1977 and 1980; residing in one district and reported to national cancer registry; followed for 5 y; disease stage not stated; Finland   551   QOL   Sick leave; KPS; notes on QOL; medical record review   N/A   No   Unknown   Bloom and Kessler, 1994 (62)  Survivor   Longitudinal cohort   Women after surgical treatment for early breast cancer, gallbladder disease, or benign breast disease or no surgery; enrolled in Psychological Aspects of Breast Cancer Study; average age 52.5 y (range, 30-69 y); 9.6% black, 3% Asian, and 3% Hispanic; all English speaking; United States   145   Perceived social support; stigma; role functioning   Perceived Social Support Scale (unpublished tool); Social Role Function and Daily Activities Scale; Family Interaction Scale from SIP; Social Health Index; MOS PF   Self-administered survey; in-person interview; 5-meeting speech sample   No   Unknown   GIVIO, 1994 (364)  Survivor   RCT   Women <70 y old with stage I, II, or III disease, randomly assigned to low- vs. high-intensity follow-up surveillance over 5-6 years; Italy   1320   QOL; satisfaction with care   25 items modified from FLIC, SIP, POMS, and CARES   Self-administered   Yes   Unknown   Mor et al., 1994 (365)  Survivor   Cohort   Women enrolled in two RCTs using similar protocols and measures; aged >24 y; state I and II disease; United States   262   QOL   MHI; Katz ADL and IADL; de novo financial impact   Telephone interview   No   Unknown   Roberts et al., 1994 (211)  Survivor   Cross-section   Women aged 29-82 y 6 mo after surgery; disease stage not stated; United States   100   Patient-MD communication; psychologic distress in 9 domains   CDIS; SCL-90-R; MD-rated health; Northhouse social support   Telephone interview; bias: PI interviewer   Yes   Unknown   Coleman et al., 1995 (366)  Survivor   Cross-section   Women aged 40-69 y with silicone implants reported to FDA as having problems after mastectomies; 97% white; United States   120   ADL; role relations; coping   Open-ended questions   Telephone interviews   N/A   Unknown   Couzi et al., 1995 (63)  Survivor   Cross-section   Postmenopausal women diagnosed with in situ or invasive locoregional breast car cer in the years 1988-1992; mean age 55 y (range, 41-65 y); 14% black; United States   190; 77% response rate   QOL; symptoms   De novo tool   Mail survey   No   Yes   German Breast Cancer Study Group, 1995 (367)  Survivor   Longitudinal cohort   Women with stage I disease receiving MST or BCS plus RT; Germany   1036; QOL available for 703   QOL   Unknown   Self-administered   No   Unknown   Liberati, 1995 (90)  Survivor   RCT   Women treated for stage I, II, or III unilateral primary breast cancer were randomly assigned to intensive surveillance vs. less intensive surveillance; <70 y old; Italy   1320; 639 with 5-y data   Overall QOL; perception of health, emotions, body image, social function, symptoms, satisfaction   De novo tool in Italian   Self-administered   Yes   Yes   Paradiso et al., 1995 (368)  Survivor   Cross-section   Representative sample of specialists, general practitioners, and patients involved in the management of follow-up practice for disease; mean age 58 y (range, 29-83 y); Italy   173; 61% response rate   Emotional response to follow-up; satisfaction   De novo tools   Mail survey   No   N/A   Schover et al., 1995 (215)  Survivor   Cross-section   Women who had partial mastectomy or had immediate breast reconstruction after mastectomy; average age 54 y; mean of 4 y after surgery; United States   218; 44% response rate   QOL and satisfaction   PAIS-SR; BES; Dyadic Adjustment Inventory; Sexual History Form   Mail survey   No   Unknown   Tasmuth et al., 1995 (369)  Survivor   Cross-section   Women who had undergone MRM or BCT; 4-7 y after surgery; ages 29-93 y; Finland   467; 92% response rate   Chronic pain   McGill; LRS   Mail survey   No   Unknown   Dow et al., 1996 (216)  Survivor   Cross-section   Women who are disease free; members of the National Coalition for Cancer Survivorship; mean age 50.9 y (range, 27-77 y); 93% white; United States   294; 43% response rate   QOL   FACT-G; QOL-CS   Mail survey   No   Unknown   Ganz et al., 1996 (85)  Survivor   Cohort   Women who had been interviewed during the 1st year after primary treatment; follow-up at 2-3 y   227; 77% response rate   QOL; psychosocial concerns   FLIC; CARES; MOS SF-36; GHQ   Mail survey; in-person interview   No   Unknown   Grunfeld et al., 1996 (370)  Survivor   RCT   Women with stage I, II or III disease at diagnosis; followed-up for recurrence at hospital vs. primary care sites; mean age 61 y; England   296; 67% response rate   QOL   MOS SF-36; EORTC-QLQ-C30; HADS   Mail survey   No   Unknown   Satariano and DeLorenze, 1996 (64)  Survivor   Longitudinal cohort   Employed women; 3 mo after being diagnosed; ages 40-84 y; reported to a SEER registry; 16% black; United States   296   Return to work   De novo tools   In-person interview   N/A   Unknown   Grunfeld et al., 1996 (370); Adewuyi-Dalton et al., 1998 (371)  Survivor   Cross-section   Women receiving follow-up care in one arm of RCT (primary care); enrolled in an RCT of primary care follow-up; England   109   Satisfaction   Qualitative interview   In-person interview   N/A   Unknown   Ashbury et al., 1998 (198)  Survivor   Case-control   Women who received services from Reach for Recovery vs. control subjects in other areas; Canada   192; 69% response rate; QOL data for 175/192   QOL; satisfaction   FLIC; FACT; Duke-UNC Functional Social Support Questionnaire; open-ended satisfaction items   Interviewer administered for case subjects; mail for control subjects   Yes   Unknown   Gulliford et al., 1997 (372)  Survivor   RCT   Women at two clinics over a 24-mo period; randomly assigned to conventional schedule of clinic visits vs. visits only after mammography; relapse-free for median of 16 mo after treatment; England   196   QOL; satisfaction; use of telephone call-in line; time and costs of follow-up   Medical Research Council QOL   Mail survey   No   Unknown   Lee, 1997 (199)  Survivor   Cross-section   Women who were up to 14 y after MST; Reach for Recovery volunteers; United States   100; 75% response rate   QOL   Ferrans and Powers QLI   Mail survey   Yes   Unknown   Poulsen et al., 1997 (373)  Survivor   RCT   Women <69 y old receiving MST vs. BCS; Denmark   184; 39.6% response rate   QOL; satisfaction   LRS; STAI   Interviewer administered   No   Unknown   Tate et al., 1997 (374)  Survivor   Cross-section   Women with disabilities and women with breast cancer; United States   216   QOL and life satisfaction   FLIC; FACT; FACT SP; SWLS   Unknown   No   Unknown   Bloom et al., 1998 (68)  Survivor   Cross-section   Women ≤50 y old (range, 21-51 y); 30% black; 6 mo after diagnosis; United States   336   QOL; MD-patient communication; body image   Illness Intrusiveness Scale; Cancer Problem Scale; SDS; Emotional Support Scale; MOS SF-36; Rosenberg's Scale of Self-Esteem   Interviewer administered in patient's home       Carpenter et al., 1998 (375,376)  Survivor   Cross-section   Women who are disease free, >3 mo after treatment; postmenopausal; 58 y (range, 36-83 y); stage 0-III; 96% white; United States   136; 114 postmenopausal   Pain; satisfaction with pain therapy; symptoms (hot flashes) and QOL   Wisconsin Brief Pain Inventory; de novo items; MOS SF12, 3 questions on hot flashes; SF12;   Phone interview   No   Unknown   Curran et al., 1998 (200)  Survivor   RCT   Women aged 23-70 y with stage I or II cancer receiving MRM vs. BCS 2 y after surgery; Europe   278   QOL; satisfaction with cosmetic result; fear of recurrence   Avery QOL   Unknown   Yes   Unknown   Dorval et al., 1998 (202)  Survivor   Longitudinal cohort   Women treated for local and regional disease; 8 y after treatment; Canada   124; 96% response rate   QOL; psychologic distress   PSI; arm problems; hospital stays; LWMAT; LES   Telephone interview   Yes   Unknown   Dorval et al., 1998 (201)  Survivor   Case-Control   Women treated for local and regional disease; 8 y after diagnosis (disease-free or with recurrences); randomly selected community control subjects; Canada   386; 96% response rate in case subjects and 61% response rate in control subjects   QOL   Number of health problems requiring hospitalization; arm problems; de novo functional status; PSI; MOS Social Support Scale; LWMAT; LES   Telephone interview   Yes   Unknown   Ferrell et al., 1998 (218)  Survivor   Cross-section   Women who are disease free; stratified by 3 age groups: <40 y old, 40-60 y old, and >60 y old; United States   298; 40% response rate   QOL; pain   QOL-BC; BPI   Mail survey   No   Unknown   Frazer et al., 1998 (203)  Survivor   Cross-section   Women seen at cancer center; average age 61 y; United States   120; 57% response rate   QOL   HSQ   Mail survey   Yes   Unknwon   Ganz et al., 1998 (67,204)  Survivor   Cross-section   Women who are disease-free; mean age 56 y (range, 31-88 y) with stage 0, I, or II disease surveyed 1-5 y after diagnosis in 2 regions; 11%-17% black per region; 1%-6% Hispanic; United States   864   QOL; sexual function   MOS SF-36; CES-D; BCPT Symptom Checklist; WSFQ; CARES   Mail survey   Yes   Unknown   Jahkola, 1998 (377)  Survivor   Cross-section   Women treated with MST or BCS; 3-8 y after surgery; mean age 60 y (range, 33-84 y); Finland   146   QOL; satisfaction   De novo tool   Mail survey   N/A   N/A   Lindley et al., 1998 (66)  Survivor   Cross-section   Women with early-stage cancer who were disease free 2-5 y after adjuvant treatment; average age 54 y (range, 29-86 y); 87.1% white; United States   120; 86 completed all data   QOL; preferences   FLIC; SDS; MOS SF-36; de novo sexuality; modified TTO preferences   Telephone interview   No   Unknown   Tomiak et al., 1998 (217)  Survivor   Costs of care   Costs of following-up women with stage I or II disease; Canada   130 MDs; 44% response rate   Follow-up costs per patient   Unit costs in the NHP   Mail survey   N/A   N/A   van Harten et al., 1998 (205)  Survivor   Cross-section   Women who were patients of 4 oncologists; The Netherlands   103; 60% response rate   QOL   CARES-SF; RSCL; QLQ; EORTC; comorbidity   Mail survey   Yes   Unknown   Velanovich and Szymanski, 1999 (378)  Survivor   Cross-section   Patients of one MD at a cancer center; >6 mo to 4 y after surgery; United States   101   Lymphedema; QOL   MOS SF-36   Self-administered in MD's office   No   Unknown   Andersen and Urban, 1999 (379)  Survivor   Cross-section   Women who are disease free; 50-85 y old; in rural and suburban communities   292   QOL   MOS SF-36; Lerman Cancer Worry Scale; de novo tool   Telephone interview   No   Unknown   Ashing-Giwa et al., 1999 (70)  Survivor   Cross-section   Women 6-8 y after surgery; age range; 32-90 y; 42% black; United States   278; 54% overall response rate; 44% in blacks; 65% in whites   QOL   MOS SF-36; CARES-SF; Ladder; Urban Life Stress Scale; ADQ   Mail survey   No   Unknown   Carpenter and Andrykowski, 1999 (380)  Survivor   Cross-section   Women who are disease-free; ≥18 y old 3 mo after treatment of 1st diagnosis; United States   114; 79% response rate   QOL; menopausal symptoms   Massachusetts Women's Health Study Questionnaire; Blatt Menopausal Index; SF-12 Health Survey   Telephone interview   Yes   Unknown   Fogarty et al., 1999 (213)  Survivor   RCT   Women diagnosed at least 6 mo before and presently disease-free or without cancer but an average of 3 friends/relatives with history of breast cancer   210   Patient anxiety; physician compassion   STAI; de novo tools   Mail survey   Yes   Unknown   Ganz et al., 1999 (81)  Survivor   Cross-section   Women who were in a partnered relationship and sexually active within the past 6 mo in Los Angeles, CA, and Washington, DC, with a diagnosis of stage, 0, I, or II disease and who completed local and adjuvant therapy; United States   1134   Sexual health   CARES Body Image Subscale; Sexual Functioning Summary Scale, Sexual Interest and Dysfunction Subscale; BCPT Symptom Checklist; Revised DAS; RAND Health Survey; WSFQ   Mail survey   No   Unknown   Grunfeld et al., 1999 (214)  Survivor   RCT   Women who received follow-up care in primary care vs. specialist care; United Kingdom   296   Patient satisfaction   De novo tools   Self-administered   Yes   Unknown   Spenser et al., 1999 (69)  Survivor   Cross-section   Women 1 y after treatment; stage 0, I, or II disease; approximately 10% black and 20% Hispanic; United States   223; 80% response rate   QOL   De novo tool on patient concerns; POMS; CES-D; Andrews and Withey adjustment; PAIS-SR; de novo body image; SIP (English and Spanish translations)   Mail survey   Yes   Unknown   Bower et al., 2000 (381)  Survivor   RCT   Women treated for early resectable disease; not receiving any treatment besides tamoxifen; in 2 large metropolitan areas; United States   1957   QOL; level of fatigue   MOS SF-36; CES-D; BCPT Symptom Checklist; MOS Sleep Scale   Mail survey   No   Unknown   Demark-Wahnefried et al., 2000 (382)  Survivor   Cross-section   Women who were identified by the Duke Cancer Database as being diagnosed with early-stage disease but who are now disease free   1666; 58% response rate   Current health behaviors; readiness to pursue life-style changes   Eating Patterns Questionnaire; de novo tools   Mail survey   No   Unknown   Wilson et al., 2000 (48)  Survivor   Cohort   Women who are disease free; in rural communities; during a 5-mo period in 1996; United States   128   Survivors' representations; positive coping strategies; negative coping strategies   Focus group   In-person interview   No   Unknown   View Large Although most of the noneconomic studies did use previously validated and reliable measures, only one quarter (n = 37 of 139; 26.6%) reported the reliability and validity of the measure in their patient population; none reported data on reliability in population subgroups (e.g., by age or race). Among the 91 economic studies, only one (196) met current standards for a good quality analysis (e.g., societal perspective, quality-adjusted using population values, discounted, including nonmedical and medical costs, and all relevant downstream costs and effects), although nonstandard approaches may be appropriate in certain circumstances or for specified purposes [e.g., evaluation within a health maintenance organization (197)]. In terms of power, only 21 studies (63,69,90,96,198-214) presented information on their power to detect clinically meaningful differences in noneconomic outcomes. Comorbidity is an important covariate that has the potential to confound outcomes results. However, comorbidity was only specifically measured in four studies—one CEA (76), two cross-sectional studies of breast cancer survivors (65,205), and one cross-sectional study of newly diagnosed breast cancer patients (92). However, results were not clearly controlled for this potential confounder in the cross-sectional studies. Similarly, a woman's baseline level of QOL is one of the strongest predictors of her long-term QOL. In an RCT, women with low and high levels of baseline QOL should be distributed randomly across study arms. In longitudinal follow-up studies, baseline QOL can be controlled for in analyses of outcomes. However, in the 46% of the noneconomic outcomes studies that employed a cross-sectional design, effects of variations in initial status were not accounted for in describing results. Additional sources of bias in interpreting existing outcomes research include low response rates. Low response rates (≤50%) are threats to internal validity (70,73,91,215-218); potential differential nonresponse, such as seen in many RCTs with QOL components [e.g., (219)], or differential losses to follow-up by treatment arm or health status [e.g., (220-222)] or response rates by group [e.g., (70,201,223)] are threats to internal validity of the results. In the metastatic disease phase, there is the further challenge of poor response rates or losses to follow-up because of severe illness or death; use of proxy respondents was not addressed in any of these studies. Finally, none of the studies evaluated whether floor or ceiling effects limited their ability to detect differences in outcome or evaluated the amount of missing data and their impact on results. Discussion At present, outcomes measurement is variable in its approach and application to the spectrum of breast cancer care. This enormous variability is evidenced by our finding that no one instrument was used in more than 10% of the studies. Although the past decade has witnessed a dramatic increase in the volume of research on breast health outcomes, large gaps exist in certain phases of care, types of outcomes, populations, and standards of measurement. For instance, only one study evaluated the quality of the dying experience for breast cancer patients, only 15.9% considered patient satisfaction, and only 4.1% included patient preferences. Only one half of the studies were controlled, and studies of survivors were the least likely to include a controlled design that accounted for baseline differences in health and functioning and other important covariates. At present, the overwhelming majority of research focuses on white, nonelderly populations. In terms of the quality of the research, this overview highlights certain cross-cutting deficiencies—no studies commented on the potential for floor or ceiling effects to influence results, only one CEA would be considered to be adequate by current standards, and, among the noneconomic studies, only four measured comorbidity, 37 tested reliability in their own patient population, and 21 noted whether they had sufficient power to detect clinically meaningful differences in outcome. These types of limitations have been noted in other reviews as well (379). Thus, we recommend that a common set of standards be established for the design and conduct of outcomes studies (Table 5), including development of standard, practical tools to measure the burden of illness (including the number of illnesses, severity, and impact on function). Table 5. Recommendations for improving breast cancer outcomes measurement Area   Recommendation   *MOS SF-36 = Medical Outcomes Study—Short Form 36.   Instruments   Develop a set of reliable, valid “core” instruments that can be used across phases of care; supplement with measures appropriate to each phase of breast cancer care. Selection of candidate instruments should be guided by consideration of patient burden and acceptability, feasibility in nonresearch settings, absence of floor or ceiling effects, applicability to multicultural groups, and sensitivity to change over time. The MOS SF-36* may not be an appropriate instrument for these purposes because of floor and ceiling effects and lack of sensitivity to changes across phases of care.   Methods   Set standards for the design and conduct of outcomes studies, including controlling for baseline characteristics or using a randomized design, a priori calculation of power for clinically meaningful outcomes, assessment of reliability, and use of proxies; apply current (minimum) standards for cost-effectiveness analyses to all economic outcome studies; and develop statistical methods to address losses to follow-up or nonresponse among severely ill patients.   Comorbidity   Develop standard, practical tools to measure burden of comorbidity (including number of illnesses, severity, and impact on function). Include comorbidity as a covariate in outcomes research; consider interactions of cancer and comorbidity in assessing outcomes.   Preferences   There needs to be additional research on practical methods to measure patient preferences; measures need to be transportable into economic analyses that calculate cost per quality-adjusted life-year gained.   Populations   Increase research in minority, multicultural, and elderly populations. Begin to include family and caregiver outcomes.   Setting   There needs to be support and partnerships to facilitate translation of outcomes research from research centers to community practices in diverse settings to understand the true effects of interventions and therapies on population-based health outcomes.   Phases of care   There should be attention to all phases of care, particularly the dying experience, primary prevention, diagnosis, adjuvant therapy, and treatment of metastatic disease. Any new survivor studies should be carefully controlled.   Outcomes   There should be an emphasis on increasing the number of studies focusing on satisfaction and patient preferences. Outcomes measuring the quality of the dying experience need to be developed, validated, and applied to breast cancer populations.   Finding   Increase funding for outcomes research especially in vulnerable populations; support the development of an infrastructure for routine outcomes data collection.   Area   Recommendation   *MOS SF-36 = Medical Outcomes Study—Short Form 36.   Instruments   Develop a set of reliable, valid “core” instruments that can be used across phases of care; supplement with measures appropriate to each phase of breast cancer care. Selection of candidate instruments should be guided by consideration of patient burden and acceptability, feasibility in nonresearch settings, absence of floor or ceiling effects, applicability to multicultural groups, and sensitivity to change over time. The MOS SF-36* may not be an appropriate instrument for these purposes because of floor and ceiling effects and lack of sensitivity to changes across phases of care.   Methods   Set standards for the design and conduct of outcomes studies, including controlling for baseline characteristics or using a randomized design, a priori calculation of power for clinically meaningful outcomes, assessment of reliability, and use of proxies; apply current (minimum) standards for cost-effectiveness analyses to all economic outcome studies; and develop statistical methods to address losses to follow-up or nonresponse among severely ill patients.   Comorbidity   Develop standard, practical tools to measure burden of comorbidity (including number of illnesses, severity, and impact on function). Include comorbidity as a covariate in outcomes research; consider interactions of cancer and comorbidity in assessing outcomes.   Preferences   There needs to be additional research on practical methods to measure patient preferences; measures need to be transportable into economic analyses that calculate cost per quality-adjusted life-year gained.   Populations   Increase research in minority, multicultural, and elderly populations. Begin to include family and caregiver outcomes.   Setting   There needs to be support and partnerships to facilitate translation of outcomes research from research centers to community practices in diverse settings to understand the true effects of interventions and therapies on population-based health outcomes.   Phases of care   There should be attention to all phases of care, particularly the dying experience, primary prevention, diagnosis, adjuvant therapy, and treatment of metastatic disease. Any new survivor studies should be carefully controlled.   Outcomes   There should be an emphasis on increasing the number of studies focusing on satisfaction and patient preferences. Outcomes measuring the quality of the dying experience need to be developed, validated, and applied to breast cancer populations.   Finding   Increase funding for outcomes research especially in vulnerable populations; support the development of an infrastructure for routine outcomes data collection.   View Large Given the complexity of breast cancer care and the heterogeneity in patient populations, no one instrument is sufficiently comprehensive, is sensitive to clinically meaningful changes in outcomes across all phases of care, and has acceptable respondent and provider burden. However, it should be possible to develop a “core” set of measures for measuring breast cancer outcomes that can be supplemented by sensitive phase-specific tools. Other issues, such as standardizing the optimal timing of measurement within and across phases, were beyond the scope of this review and are important to address in future research. Finally, it will be important to examine whether conclusions about outcomes are affected by choice of instrument. Our review also highlights the paucity of patient preference data. We suggest that additional research be conducted to develop practical methods to measure patient preferences and that these measures be transportable into economic analyses that calculate cost per quality-adjusted life-year gained. More work is also necessary to understand the quality of the dying experience from both the patient's and the caregiver's perspectives. In summary, more research is needed to develop standard approaches that are 1) practical in a variety of health care settings, 2) reliable and valid, 3) applicable to broad age and race groups and culturally diverse populations, 4) useful to track changes in outcomes as individuals move through the phases of cancer care, and 5) informative for designing interventions to improve the quality of breast cancer services across the entire spectrum of care. Partnerships to facilitate translation of outcomes research from research centers to diverse community practices will be essential for reaching these goals. Supported in part by Public Health Service (PHS) grants HS08395 from the Agency for Health Care Policy and Research, Office of the Assistant Secretary for Health, Department of Health and Human Services (DHHS) (J. Mandelblatt); by grant DAMD17-94-J-4212 from the Department of the Army, Breast Cancer Center Grant (J. Mandelblatt, W. Liang, and W. 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