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Functioning in the fibromyalgia syndrome: validity and reliability of the WHODAS 2.0

Functioning in the fibromyalgia syndrome: validity and reliability of the WHODAS 2.0 Background: Fibromyalgia syndrome (FMS) is both a challenging and disabling condition. The International Asso- ciation for the Study of Pain (IASP) classifies FMS as chronic primary pain, and it can negatively impact individuals’ functioning including social, psychological, physical and work-related factors. Notably, while guidelines recommend a biopsychosocial approach for managing chronic pain conditions, FMS assessment remains clinical. The WHODAS 2.0 is a unified scale to measure disability in the light of the International Classification of Functioning, Disability and Health. Thus, this study aimed to evaluate the reliability and validity of the Brazilian version of WHODAS 2.0 for use in individu- als with FMS. Methods: Methodological study of the validity and reliability of the Brazilian version of the 36-item WHODAS 2.0 with 110 individuals with FMS. The instrument gives a score from 0 to 100, the higher the value, the worse the level of func- tioning. We assessed participants with Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) (0–100), Fibromyalgia Impact Questionnaire (FIQ) (0–10) and Beck Depression Inventory instrument (BDI) (0–63). The construct validity, internal consistency, and test–retest stability. We used SF-36, FIQ and BDI to study construct validity analysis. For statistical analysis, we performed the intraclass correlation (ICC), Spearman correlation, and Cronbach’s alpha, with a statistical level of 5%. Results: Most participants were female (92.27%), aged 45 (± 15) years. The test–retest reliability analysis (n = 50) showed stability of the instrument (ICC = 0.54; ρ = 0.84, p < 0.05). The test–retest correlation between the domains was moderate to strong (ρ > 0.58 and < 0.90). Internal consistency was satisfactory for total WHODAS 2.0 (0.91) and also for domains, ranging from 0.44 to 0.81. The construct validity showed satisfactory values with all moderately cor- related with WHODAS 2.0 instruments (> 0.46 and < 0.64; p < 0.05). WHODAS 2.0 evaluates the functioning encompass- ing components of health-related quality of life, functional impact, and depressive symptoms in those with FMS. Conclusions: WHODAS 2.0 is a reliable and valid instrument to evaluate functioning of Brazilians with FMS. It pro- vides reliable information on individuals’ health through of a multidimensional perspective, that allows for individual- centered care. Keywords: Fibromyalgia syndrome, Disability, Chronic pain, Patient reported outcome measures, WHO Background Fibromyalgia Syndrome (FMS) is a disabling health con- dition that deserves to be highlighted [1]. The Interna - tional Association for the Study of Pain (IASP) classifies *Correspondence: aclnunes@gmail.com 2 FMS as chronic primary pain [2], and it can negatively Department of Physical Therapy, Federal University of Ceará, Major Weyne Street, 1440, Fortaleza, CE 60430-450, Brazil impact patients’ functioning including social, psychologi- Full list of author information is available at the end of the article cal, physical and work-related factors[3]. Notably, while © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. Barreto et al. Adv Rheumatol (2021) 61:58 Page 2 of 8 guidelines recommend a biopsychosocial approach for pain management approach refers to a biopsychosocial managing chronic pain[4, 5] FMS assessment remains model of pain that directs attention to suffering, Quality clinical. of Life (QoL), and participation in family and other areas FMS has an uncertain diagnosis due to reliance on of social life[3]. The WHODAS 2.0 emerges as an alterna - patient report of subjective symptoms, absence of a uni- tive to address this shortage. With the validation of this versally accepted diagnostic gold standard, and lack of a instrument, a tool to globally and efficiently assess indi - specific biomarker[1]. There is a disagreement between viduals with FMS will be available. The aim of our study FMS criteria and clinician-based FMS diagnoses that sug- was to evaluate the validity and reliability of the WHO- gests bias in the identification of this health condition[6]. DAS 2.0 (Brazil) for individuals with FMS. Furthermore, individuals with FMS tend to report a com- plex set of concerns, including fatigue, sleep dysfunc- Materials and methods tion, stiffness, depression, anxiety, poor physical capacity, This was a methodological study that evaluated the and cognitive disturbance in addition to musculoskeletal psychometric properties of the WHODAS 2.0 (Brazil) pain[7, 8]. These should be described as negative aspect instrument in people with FMS. The measurement prop - of functioning associated with chronic pain[3]. erties were defined according to the recommendations Increased attention to the functional impact of of the COnsensus-based Standards for the selection of chronic pain is an important step forward for its man- health Measurement INstruments (COSMIN)[17]. agement. Functioning is a relevant indicator of popula- tion health[9], as it considers the dynamic interaction Participants between a person’s health status and contextual fac- Recruitment occurred through the referral of health tors[10]. The analysis of the functioning covers the professionals, active searching in a health unit, and structures and functions of the body, activities and par- social media dissemination. Eligible participants were ticipation, in addition to contextual factors, which allows male or female, 18  years of age or older, who met the to understand and measure the health status through of FM diagnostic criteria of the 1990 American College of a multidimensional perspective [9, 11]. This concept of Rheumatology[18]. functioning and its application as well as the term dis- Individuals who presented any disease or disorder that ability, were proposed by International Classification of led to some functional impairment that was not linked to Functioning, Disability and Health (ICF) based on the the characteristics of FMS and/or cognitive impairment biopsychosocial model [10, 12]. that prevented them from responding to the instruments Considering the fact that people with one and the same were excluded from the study. The minimum sample size clinical condition can vary substantially in terms of dis- to meet the necessary criteria of the validation process ability, there is a need to expand the assessment tools [3]. was 100 individuals[19]. The instruments commonly used to assess outcomes in Our study included 110 participants and was approved FMS are not aligned with all categories of functioning as by the Research Ethics Committee  (n.1.918.391), in defined by the ICF[13, 14]. The World Health Organiza - accordance with the ethical standards of the institutional tion Disability Assessment Schedule 2.0 (WHODAS 2.0) and/or national research committee and with the 1964 is a tool that measure functioning based on the theoreti- Helsinki Declaration. All participants were informed of cal conceptual framework of the ICF. the objectives of the study and gave written consent for The WHODAS 2.0 is a generic instrument that provides their voluntary participation in the study and the anony- the level of functioning in the following six domains: mous use of personal data in statistical analyses. cognition, mobility, self-care, getting along, life activi- ties, and participation, and its psychometric properties Outcomes are considered satisfactory[15]. The 12-item version of Functioning—world health organization disability WHODAS 2.0 has already been validated for the popula- assessment schedule 2.0 (WHODAS 2.0) tion with FMS in the United States[16]. The 36-item ver - The functioning was measured by WHODAS 2.0 in the sion of WHODAS 2.0 is the most detailed and it allows following six domains: cognition, mobility, self-care, users to generate scores for the six domains of function- getting along, life activities, and participation. For the ing and to calculate an overall functioning score[15]. This purpose of this study, we used the interview 36-item version is not validated to evaluate individuals with FMS. version. It allows for scoring each domain, and the gen- Knowledge of the functioning profile of individuals with eral functioning score. Each domain and the total score FMS is needed for more appropriate and effective clini - range from 0 to 100, where a score closer to 100 indicates cal management, especially because FMS is a multifac- worse functioning of the individual. This instrument has torial and multisystemic condition[13]. The multimodal excellent psychometric properties based on the strong Bar reto et al. Adv Rheumatol (2021) 61:58 Page 3 of 8 test–retest reliability values found in a study conducted pain[24]. For eligible individuals, the WHODAS 2.0, FIQ, in 36 countries[15]. WHODAS was translated and cross- SF-36, and BDI instruments were applied. After 7  days, cultural adapted to the Brazilian Portuguese and the final participants returned to perform the retest with the same version was approved by WHO [20]. researcher, who applied the WHODAS 2.0 instrument. Fibromyalgia impact—fibromyalgia impact questionnaire Statistical analysis (FIQ) The validation process was composed of the analysis of This instrument assesses the impact of FMS on QoL. It the following psychometric properties: reliability, inter- is currently the most widely used questionnaire in clini- nal consistency, and construct validity. The analysis cal practice and research and is used to assess the health included the subjects who answered all necessary items status of individuals with FMS. The FIQ has 19 goal char - of the instruments. For test–retest reliability measure- acter items divided into 10 questions related to function, ment, data from 50 subjects were analyzed, a number overall impact and symptoms. The final score ranges considered adequate for analysis[19]. For the analysis of from 0 to 10; the higher the score, the greater the impact the other psychometric properties, 110 individuals were on QoL[21]. included. Test–retest reliability is obtained when the same instru- Quality of life—medical outcomes study 36‑ item short‑form ment is applied twice to the same subject with an interval health survey (SF‑36) of seven days between applications. The instrument is The SF-36 is a generic multidimensional questionnaire considered stable when the coefficient values are greater that is used to assess the self-perception of QoL and than 0.7[25, 26]. health status. Its 36 items encompass eight domains, Internal consistency evaluates the relationship between namely: physical functioning, role physical, bodily pain, instrument sub-items within the same domain. This was general health, vitality, social functioning, role emo- evaluated using Cronbach’s alpha, which analyses the tional, and mental health. The final score is separated by degree of covariance between the sub-items. The instru - domains, where each value can be between 0 and 100; ment has good internal consistency when its domains the closer the value is to 100, the better the respondent’s present Cronbach’s alpha values between 0.7 and QoL. The instrument presented significant results and 0.95[26]. satisfactory values for intra- and inter-rater correlation. Construct validity investigate validity of an instrument The same was found in the construct validity analysis[22]. in relationships with other outcomes measures of good quality[27]. This property was measured by application Depressive symptoms—beck depression inventory (BDI) of another instrument that has already been validated The instrument was used to detect depressive symp - for the same population. Correlation values g reater than toms. The instrument has 21 items, ranging from 0 to 0.7 indicate strong correlation[26, 28]. For this evalua- 3 points. The higher the individual’s score, the greater tion, the correlation between the WHODAS 2.0 and the the likelihood of depressive symptoms, which should FIQ and SF-36 instruments, which are widely used for be confirmed with other diagnostic tests. The instru - FMS and QoL impact analysis, respectively, was per- ment presented high internal consistency (0.81), and sig- formed. In addition, the correlation between the WHO- nificant values, and strong correlation in the construct DAS 2.0 domains and SF-36 domains, FIQ and BDI was validity[23]. analyzed.  Table  1 shows plausible relationships between WHODAS 2.0 domains and SF36, FIQ, BDI. Procedures To describe the clinical, sociodemographic, and func- The researchers were previously trained to apply the tioning characteristics of the study participants, the fol- instruments and to confirm the diagnostic criteria for lowing descriptive measures were used: measures of FMS. Data collection occurred in a reserved room at the central tendency (mean), dispersion (standard deviation), universities from August 2017 to July 2019. and relative frequency (%). The collected data were ana - Categorical sociodemographic variables (gender, race, lyzed using the Stata program, adopting a significance marital status, profession, comorbidity, pain body places) level of α = 0.05. and continuous variables (age, number of children, years Initially, the normality of the data was tested with the of schooling, symptom evolution time, medications, Kolmogorov–Smirnov test[29]. Test–retest reliability numerical rating scale—NRS) were collected by means of was analyzed using the intraclass correlation coeffi - an evaluation questionnaire prepared by the researchers. cient (ICC), followed by the Spearman correlation test NRS is a measure of pain intensity of 11 points (0–10). between the WHODAS 2.0 domain and total values Score zero means no pain and score 10 means worst found in the test and retest. This strategy of using two Barreto et al. Adv Rheumatol (2021) 61:58 Page 4 of 8 Table 1 Hypothesized correlations between the WHODAS along showed a moderate and significant correlation with 2.0 domains, total WHODAS 2.0 and the SF36, FIQ and BDI the total BDI value (Table 4). instruments Discussion WHODAS 2.0SF36FIQ BDI Our study showed that the WHODAS 2.0 is a valid and Cognition reliable instrument to measure functioning in individuals Mobility with FMS, presenting adequate psychometric properties. Self-Care The WHODAS 2.0 assesses functioning of individuals with FMS, incorporating aspects of health-related QoL, Getting along functional impact, and depressive symptoms. The WHO - Life activity DAS 2.0 offers the opportunity to evaluate the chronic Work activity patient, as in osteoarthritis[31] or rheumatoid arthritis, according to the ICF biopsychosocial model. Domestic activity The WHODAS 2.0 maintains excellent internal consist - Participation ency when evaluating individuals with FM. In this way, Total issues from the same domain and from the entire instru- ment are adequately related, and the interpretation of the scores reflects the level of functioning[32, 33]. Studies that evaluated the psychometric properties of the WHO- statistical tests is due to the nature of the tests in associa- DAS 2.0 in musculoskeletal and rheumatic conditions tion with the characteristics of FM. The ICC is a measure found similar results[34, 35]. of agreement. The correlation is considered strong when Additionally, our findings showed acceptable test– the value is higher than 0.7, moderate when it is between retest reliability but the domains of life activity and par- 0.4 and 0.7, and weak when it is less than 0.4[30]. We ticipation showed less stability in individuals with FMS verified the internal consistency according to Cronbach’s after one week. These results are probably due to FMS alpha. To assess the construct validity, we use the Spear- being a health condition with a wide variety of transient man correlation test between the domains and the total symptoms[13, 36], and changes may occur between two WHODAS 2.0 score, and FIQ and SF-36. time points. We hypothesize that the WHODAS 2.0 is capable of detecting minimal changes in these domains, Results however, the responsiveness of this instrument needs We evaluated 110 people with a diagnosis of FMS. The to be tested in a future study. The application of instru - participant data and the average value of the instruments ments addressing general health at the time of reapplica- are described in Table  2. The sample consisted primarily tion of the WHODAS 2.0 could confirm this hypothesis. of women (97.27%), aged 44.66 (± 14.69) years, who had The WHODAS 2.0 is an instrument that includes all paid work (21.82%) or were unemployed due to health ICF concepts for the evaluation of functioning[15]. Our problems (19.09%). The pain intensity level was 6.38 validation results reinforced the multidimensional nature (± 2.56). of this instrument, which covers part of the domains of The measures referring to the instrument’s psychomet - the three investigated instruments such as QoL, func- ric properties are described in Table  3. Results indicate tional impact and depressive symptoms. Additionally, the satisfactory values for internal consistency. In the test– WHODAS 2.0 covers other aspects not included in this retest reliability, we found between moderate to high ICC questionnaires[37]. The 12-item version WHODAS 2.0 values (except for life activities, whose work activities was related to fatigue, pain, sleep difficulties, cognitive were not responded by 57% of the sample), and the cor- impairment, depression, and social support in individuals relation coefficient was moderate to strong. with FMS[16]. In the construct validity analysis, the WHODAS 2.0 The scores of the investigated questionnaires were showed a moderate and significant correlation with the related to some of the WHODAS 2.0 domains. An SF-36, FIQ, and BDI. The WHODAS 2.0 domains, except example is FIQ, which had a moderate correlation with for the work activity domain, showed a moderate and sig- two WHODAS 2.0 domains, mobility and life activities nificant correlation with SF-36. The mobility domain and (domestic activity). These results demonstrated whereas domestic activity (life activities domain) of the WHO- FIQ is a specific instrument for assessing the health DAS 2.0 showed a moderate and significant correlation impact of individuals with FM[21], it fails to evaluate with the FIQ, and the domains of cognition and getting other functioning related domains such as cognition, self-care, and getting along. According to Prodinger et al. Bar reto et al. Adv Rheumatol (2021) 61:58 Page 5 of 8 Table 2 Description of the sociodemographic, clinical, and functional characteristics Variable n % (100) Sex Woman 107 92.27 Man 3 2.73 Marital status Never married 38 34.86 Currently married 42 38.53 Separated 9 8.26 Divorced 15 13.76 Widower 3 2.75 Cohabiting 2 1.83 Race White 14 16.86 Brown 35 42.16 Negro 30 36.14 Indigenous 4 4.82 Income Less than 1 minimum Brazilian wage 15 18.07 1–2 minimum Brazilian wage 38 45.78 3–5 minimum Brazilian wage 23 27.72 More than 5 minimum Brazilian wage 7 8.43 Work activity Paid work 24 21.82 Freelance 13 11.82 Non-paid work, such as volunteer or charity 2 1.82 Student 11 10 Homemaker 14 12.73 Retired 12 10.91 Unemployed (health reasons) 21 19.09 Unemployed (other reasons) 5 4.54 Other 8 7.27 Mean Standard deviation Age 44.66 14.69 How many years spent studying 16.10 8.83 NRS 6.38 2.56 FIQ 6.73 1.55 BDI 22.59 10.21 WHODAS 2.0 Cognition 43.63 20.23 Mobility 55.73 20.72 Self-care 27.18 22.67 Getting along 32.04 23.52 Life activity 46.70 21.62 Domestic activity 7.1.54 22.14 Work activity 60.10 20.56 Participation 55.00 19.92 Total 44.97 14.93 SF36 Physical functioning 36.10 17.70 Role physical 17.65 21.04 Barreto et al. Adv Rheumatol (2021) 61:58 Page 6 of 8 Table 2 (continued) Mean Standard deviation Bodily pain 23.45 20.25 General health 37.97 23.13 Vitality 24.93 21.63 Social functioning 39.95 23.41 Role emotional 29.37 34.15 Mental health 49.85 22.02 Total 32.92 12.53 Value referring to 83 individuals with FMS. NRS = Numeric Rating Scale; FIQ = Fibromyalgia Impact Questionnaire; WHODAS = World Health Organization Disability Assessment Schedule; SF36 = Medical Outcomes Study 36- Item Short-Form Health Survey; BDI = Beck Depression Index Table 3 Reliability (Cronbach’s α and ICC) of the WHODAS 2.0 domains Domains WHODAS 2.0 Cronbach’s α ICC (95%) Test–retest correlation coefficient Cognition 0.77 0.61 (0.34–0.87) 0.83* Mobility 0.81 0.79 (0.40- 0.95) 0.90* Self-care 0.76 0.67 (0.40 – 0.95) 0.79* Getting along 0.73 0.67 (0.41–0.93) 0.65* Life activity 0.44 0.41 (0.07- 0.74) 0.62* Domestic activity 0.62 0.31(0.00–0.67) 0.65* Work activity 0.53 0.49 (0.06–0.92) 0.58* Participation 0.80 0.26 (0.00–0.60) 0.59* Total 0.91 0.54 (0.13–0.95) 0.84* p < 0.05; WHODAS = World Health Organization Disability Assessment Schedule Table 4 Correlation coefficient matrix between the domains of WHODAS 2.0, SF36, BDI and FIQ WHODAS 2.0 Domains Cognition Mobility Self-care Getting along Life activity Work activity Domestic Participation Total activity SF 36 SF36 Total − 0.4055* − 0.4716* − 0.5394* − 0.5462* − 0.4436* − 0.2242 − 0.5522* − 0.4819* − 0.6435* Physical Function- − 0.3403* − 0.5581* − 0.4397* − 0.2362 − 0.4917* − 0.3756* − 0.4509* − 0.2828* − 0.4894* ing Role Physical − 0.1648 − 0.2165 − 0.3209* − 0.2201 − 0.2657 − 0.0394 − 0.4692* − 0.3264* − 0.3301* Bodily Pain − 0.1658 − 0.1783 − 0.0933 0.0319 − 0.1750 − 0.0431 − 0.2258 − 0.0593 − 0,2001* General Health − 0.2017 − 0.3715* − 0.5347* − 0.3230* − 0.4297* − 0.2075 − 0.5094* − 0.3377* − 0.4483* Vitality − 0.2821* − 0.3880* − 0.3269* − 0.1622 − 0.1715 − 0.0124 − 0.3146* − 0.3150* − 0.4100* Social Function- − 0.3268* − 0.2279 − 0.1436 − 0.3691* − 0.2875* − 0.2328 − 0.2485 − 0.2066 − 0.3664* ing Role Emotional − 0.0244 − 0.0095 − 0.2995* − 0.3411* − 0.1032 − 0.0236 − 0.1586 − 0.0353 − 0.1165 Mental Health − 0.3287* − 0.2005 − 0.0588 − 0.3317* − 0.1434 − 0.1130 − 0.1517 − 0.2844* − 0.2832* FIQ 0.3419* 0.4355* 0.3105* 0.1857 0.3894* 0.1833 0.4640* 0.3615 0.4857* BDI 0.5005* 0.3767* 0.2828 0.5276* 0.2643 0.2528 0.2387 0.2866 0.4616* p < 0.05; FIQ = Fibromyalgia Impact Questionnaire; WHODAS = World Health Organization Disability Assessment Schedule; SF36 = Medical Outcomes Study 36- Item Short-Form Health Survey; BDI = Beck Depression Index [38], a specific instrument might raise difficulties asso - 2.0 domains allows to identify typical disabilities of the ciated with the multidimensionality and functioning. FMS[3], which cannot be performed in the 12-item ver- This more detailed analysis according to the WHODAS sion of WHODAS[15]. Bar reto et al. Adv Rheumatol (2021) 61:58 Page 7 of 8 We observed that higher scores on health-related QoL on our findings we recommend using the instrument to were related to a better functioning profile in WHO - assess health status and to monitor health interventions. DAS 2.0. The total score of the SF-36 showed moderate correlation in 7 of the 8 domains of the WHODAS 2.0. Abbreviations However, neither the mental health, role emotional nor FMS: Fibromyalgia syndrome; QoL: Quality of life; ICF: International clas- the bodily pain SF-36 domains seem to be well explored sification of functioning, disability and health; WHODAS 2.0: World health organization disability assessment schedule 2.0; FIQ: Fibromyalgia Impact in WHODAS 2.0. These findings support the use of the Questionnaire; SF-36: Medical outcomes study 36-item short-form health sur- SF-36 as an outcome which complements WHODAS 2.0, vey; BDI: Beck depression inventory; NRS: Numerical rating scale; ICC: Intraclass as suggested Garin et  al.[35], who correlated the WHO- correlation coefficient. DAS 2.0 with the SF-36 for individuals with different Acknowledgements chronic diseases, and showed a moderate correlation in To the Movement project of the Department of Physiotherapy, Federal Univer- all analyses. Xenouli et al.[39] divided the SF-36 domains sity of Ceará. into two blocks, physical and mental health, and cor- Authors’ contributions related them with the total value of the WHODAS 2.0. MCAB collected data, contributed to the writing of the article, statistical The correlation between the total score of the WHO - analysis and final review; FRJM contributed to data collection, article writing and final review; CVG contributed to data collection and final review; CCL DAS 2.0 and the physical health SF-36 component was contributed to the writing of the article and final review; SSC performed the strong (r = –0.76) in Greeks with or without disabilities, statistical analysis, contributed to the writing of the article and final review; while the correlation was moderate between the WHO- ACLN supervised the project, contributed to data collection, statistical analysis, article writing and final review. All authors read and approved the final DAS 2.0 and the SF-36 mental health component (–0.50) manuscript. [39]. SF-36 was chosen because it is a generic question- naire that makes a global analysis of the QoL of the Funding This research did not receive any specific grant from funding agencies in the individual[22]. public, commercial, or not-for-profit sectors. The moderate correlation between BDI and WHO - DAS 2.0 suggests that important aspects of depressive Availability of data and materials The datasets used and/or analyzed during the current study are available from symptoms are covered in this functioning tool, especially the corresponding author on reasonable request. through the domains of cognition, mobility and getting along with people. Still it SF-36 and the BDI assess differ - Declarations ent outcomes when compared to the WHODAS 2.0[22, 23]. In addition, the instruments refer to different peri - Ethics approval and consent to participate This study was approved by the Research Ethics Committee of the University ods of symptom presentation, which can influence the of Triângulo Mineiro (1.918.391). patient’s report[21, 23]. Still, these instruments were included because they are the most used to assess indi- Consent for publication Not applicable. viduals with FMS. Our study is the first to investigate the correlation of the WHODAS 2.0 with FIQ and BDI. Competing interests We had some limitations in this study. We did not The authors declare that they have no competing interests. reapply a concurrent instrument at the time of the sec- Author details ond application of the WHODAS 2.0, which limits the 1 Department of Public Health, Universidade Federal do Ceará, Ceará, Fortaleza, perception of individual conditions on the day of the Brazil. Department of Physical Therapy, Federal University of Ceará, Major Weyne Street, 1440, Fortaleza, CE 60430-450, Brazil. Department of Physical retest. Another limitation is the functioning in life activi- Therapy, Universidade Federal do Triângulo Mineiro, Ceará, Uberaba, Brazil. ties because it includes the work activities that are not applied to all individuals. We highlight that the findings Received: 6 July 2021 Accepted: 6 September 2021 of the present study are unprecedented since the psycho- metric properties of the the 36-item version WHODAS 2.0 have not been tested for FMS individuals. References 1. Benlidayi IC. Fibromyalgia as a challenge for patients and physi- cians. Rheumatol Int. 2018;38(12):2345. https:// doi. org/ 10. 1007/ Conclusions s00296- 018- 4138-6. 2. Treede R-D, Rief W, Barke A, et al. 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Functioning in the fibromyalgia syndrome: validity and reliability of the WHODAS 2.0

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Abstract

Background: Fibromyalgia syndrome (FMS) is both a challenging and disabling condition. The International Asso- ciation for the Study of Pain (IASP) classifies FMS as chronic primary pain, and it can negatively impact individuals’ functioning including social, psychological, physical and work-related factors. Notably, while guidelines recommend a biopsychosocial approach for managing chronic pain conditions, FMS assessment remains clinical. The WHODAS 2.0 is a unified scale to measure disability in the light of the International Classification of Functioning, Disability and Health. Thus, this study aimed to evaluate the reliability and validity of the Brazilian version of WHODAS 2.0 for use in individu- als with FMS. Methods: Methodological study of the validity and reliability of the Brazilian version of the 36-item WHODAS 2.0 with 110 individuals with FMS. The instrument gives a score from 0 to 100, the higher the value, the worse the level of func- tioning. We assessed participants with Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) (0–100), Fibromyalgia Impact Questionnaire (FIQ) (0–10) and Beck Depression Inventory instrument (BDI) (0–63). The construct validity, internal consistency, and test–retest stability. We used SF-36, FIQ and BDI to study construct validity analysis. For statistical analysis, we performed the intraclass correlation (ICC), Spearman correlation, and Cronbach’s alpha, with a statistical level of 5%. Results: Most participants were female (92.27%), aged 45 (± 15) years. The test–retest reliability analysis (n = 50) showed stability of the instrument (ICC = 0.54; ρ = 0.84, p < 0.05). The test–retest correlation between the domains was moderate to strong (ρ > 0.58 and < 0.90). Internal consistency was satisfactory for total WHODAS 2.0 (0.91) and also for domains, ranging from 0.44 to 0.81. The construct validity showed satisfactory values with all moderately cor- related with WHODAS 2.0 instruments (> 0.46 and < 0.64; p < 0.05). WHODAS 2.0 evaluates the functioning encompass- ing components of health-related quality of life, functional impact, and depressive symptoms in those with FMS. Conclusions: WHODAS 2.0 is a reliable and valid instrument to evaluate functioning of Brazilians with FMS. It pro- vides reliable information on individuals’ health through of a multidimensional perspective, that allows for individual- centered care. Keywords: Fibromyalgia syndrome, Disability, Chronic pain, Patient reported outcome measures, WHO Background Fibromyalgia Syndrome (FMS) is a disabling health con- dition that deserves to be highlighted [1]. The Interna - tional Association for the Study of Pain (IASP) classifies *Correspondence: aclnunes@gmail.com 2 FMS as chronic primary pain [2], and it can negatively Department of Physical Therapy, Federal University of Ceará, Major Weyne Street, 1440, Fortaleza, CE 60430-450, Brazil impact patients’ functioning including social, psychologi- Full list of author information is available at the end of the article cal, physical and work-related factors[3]. Notably, while © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. Barreto et al. Adv Rheumatol (2021) 61:58 Page 2 of 8 guidelines recommend a biopsychosocial approach for pain management approach refers to a biopsychosocial managing chronic pain[4, 5] FMS assessment remains model of pain that directs attention to suffering, Quality clinical. of Life (QoL), and participation in family and other areas FMS has an uncertain diagnosis due to reliance on of social life[3]. The WHODAS 2.0 emerges as an alterna - patient report of subjective symptoms, absence of a uni- tive to address this shortage. With the validation of this versally accepted diagnostic gold standard, and lack of a instrument, a tool to globally and efficiently assess indi - specific biomarker[1]. There is a disagreement between viduals with FMS will be available. The aim of our study FMS criteria and clinician-based FMS diagnoses that sug- was to evaluate the validity and reliability of the WHO- gests bias in the identification of this health condition[6]. DAS 2.0 (Brazil) for individuals with FMS. Furthermore, individuals with FMS tend to report a com- plex set of concerns, including fatigue, sleep dysfunc- Materials and methods tion, stiffness, depression, anxiety, poor physical capacity, This was a methodological study that evaluated the and cognitive disturbance in addition to musculoskeletal psychometric properties of the WHODAS 2.0 (Brazil) pain[7, 8]. These should be described as negative aspect instrument in people with FMS. The measurement prop - of functioning associated with chronic pain[3]. erties were defined according to the recommendations Increased attention to the functional impact of of the COnsensus-based Standards for the selection of chronic pain is an important step forward for its man- health Measurement INstruments (COSMIN)[17]. agement. Functioning is a relevant indicator of popula- tion health[9], as it considers the dynamic interaction Participants between a person’s health status and contextual fac- Recruitment occurred through the referral of health tors[10]. The analysis of the functioning covers the professionals, active searching in a health unit, and structures and functions of the body, activities and par- social media dissemination. Eligible participants were ticipation, in addition to contextual factors, which allows male or female, 18  years of age or older, who met the to understand and measure the health status through of FM diagnostic criteria of the 1990 American College of a multidimensional perspective [9, 11]. This concept of Rheumatology[18]. functioning and its application as well as the term dis- Individuals who presented any disease or disorder that ability, were proposed by International Classification of led to some functional impairment that was not linked to Functioning, Disability and Health (ICF) based on the the characteristics of FMS and/or cognitive impairment biopsychosocial model [10, 12]. that prevented them from responding to the instruments Considering the fact that people with one and the same were excluded from the study. The minimum sample size clinical condition can vary substantially in terms of dis- to meet the necessary criteria of the validation process ability, there is a need to expand the assessment tools [3]. was 100 individuals[19]. The instruments commonly used to assess outcomes in Our study included 110 participants and was approved FMS are not aligned with all categories of functioning as by the Research Ethics Committee  (n.1.918.391), in defined by the ICF[13, 14]. The World Health Organiza - accordance with the ethical standards of the institutional tion Disability Assessment Schedule 2.0 (WHODAS 2.0) and/or national research committee and with the 1964 is a tool that measure functioning based on the theoreti- Helsinki Declaration. All participants were informed of cal conceptual framework of the ICF. the objectives of the study and gave written consent for The WHODAS 2.0 is a generic instrument that provides their voluntary participation in the study and the anony- the level of functioning in the following six domains: mous use of personal data in statistical analyses. cognition, mobility, self-care, getting along, life activi- ties, and participation, and its psychometric properties Outcomes are considered satisfactory[15]. The 12-item version of Functioning—world health organization disability WHODAS 2.0 has already been validated for the popula- assessment schedule 2.0 (WHODAS 2.0) tion with FMS in the United States[16]. The 36-item ver - The functioning was measured by WHODAS 2.0 in the sion of WHODAS 2.0 is the most detailed and it allows following six domains: cognition, mobility, self-care, users to generate scores for the six domains of function- getting along, life activities, and participation. For the ing and to calculate an overall functioning score[15]. This purpose of this study, we used the interview 36-item version is not validated to evaluate individuals with FMS. version. It allows for scoring each domain, and the gen- Knowledge of the functioning profile of individuals with eral functioning score. Each domain and the total score FMS is needed for more appropriate and effective clini - range from 0 to 100, where a score closer to 100 indicates cal management, especially because FMS is a multifac- worse functioning of the individual. This instrument has torial and multisystemic condition[13]. The multimodal excellent psychometric properties based on the strong Bar reto et al. Adv Rheumatol (2021) 61:58 Page 3 of 8 test–retest reliability values found in a study conducted pain[24]. For eligible individuals, the WHODAS 2.0, FIQ, in 36 countries[15]. WHODAS was translated and cross- SF-36, and BDI instruments were applied. After 7  days, cultural adapted to the Brazilian Portuguese and the final participants returned to perform the retest with the same version was approved by WHO [20]. researcher, who applied the WHODAS 2.0 instrument. Fibromyalgia impact—fibromyalgia impact questionnaire Statistical analysis (FIQ) The validation process was composed of the analysis of This instrument assesses the impact of FMS on QoL. It the following psychometric properties: reliability, inter- is currently the most widely used questionnaire in clini- nal consistency, and construct validity. The analysis cal practice and research and is used to assess the health included the subjects who answered all necessary items status of individuals with FMS. The FIQ has 19 goal char - of the instruments. For test–retest reliability measure- acter items divided into 10 questions related to function, ment, data from 50 subjects were analyzed, a number overall impact and symptoms. The final score ranges considered adequate for analysis[19]. For the analysis of from 0 to 10; the higher the score, the greater the impact the other psychometric properties, 110 individuals were on QoL[21]. included. Test–retest reliability is obtained when the same instru- Quality of life—medical outcomes study 36‑ item short‑form ment is applied twice to the same subject with an interval health survey (SF‑36) of seven days between applications. The instrument is The SF-36 is a generic multidimensional questionnaire considered stable when the coefficient values are greater that is used to assess the self-perception of QoL and than 0.7[25, 26]. health status. Its 36 items encompass eight domains, Internal consistency evaluates the relationship between namely: physical functioning, role physical, bodily pain, instrument sub-items within the same domain. This was general health, vitality, social functioning, role emo- evaluated using Cronbach’s alpha, which analyses the tional, and mental health. The final score is separated by degree of covariance between the sub-items. The instru - domains, where each value can be between 0 and 100; ment has good internal consistency when its domains the closer the value is to 100, the better the respondent’s present Cronbach’s alpha values between 0.7 and QoL. The instrument presented significant results and 0.95[26]. satisfactory values for intra- and inter-rater correlation. Construct validity investigate validity of an instrument The same was found in the construct validity analysis[22]. in relationships with other outcomes measures of good quality[27]. This property was measured by application Depressive symptoms—beck depression inventory (BDI) of another instrument that has already been validated The instrument was used to detect depressive symp - for the same population. Correlation values g reater than toms. The instrument has 21 items, ranging from 0 to 0.7 indicate strong correlation[26, 28]. For this evalua- 3 points. The higher the individual’s score, the greater tion, the correlation between the WHODAS 2.0 and the the likelihood of depressive symptoms, which should FIQ and SF-36 instruments, which are widely used for be confirmed with other diagnostic tests. The instru - FMS and QoL impact analysis, respectively, was per- ment presented high internal consistency (0.81), and sig- formed. In addition, the correlation between the WHO- nificant values, and strong correlation in the construct DAS 2.0 domains and SF-36 domains, FIQ and BDI was validity[23]. analyzed.  Table  1 shows plausible relationships between WHODAS 2.0 domains and SF36, FIQ, BDI. Procedures To describe the clinical, sociodemographic, and func- The researchers were previously trained to apply the tioning characteristics of the study participants, the fol- instruments and to confirm the diagnostic criteria for lowing descriptive measures were used: measures of FMS. Data collection occurred in a reserved room at the central tendency (mean), dispersion (standard deviation), universities from August 2017 to July 2019. and relative frequency (%). The collected data were ana - Categorical sociodemographic variables (gender, race, lyzed using the Stata program, adopting a significance marital status, profession, comorbidity, pain body places) level of α = 0.05. and continuous variables (age, number of children, years Initially, the normality of the data was tested with the of schooling, symptom evolution time, medications, Kolmogorov–Smirnov test[29]. Test–retest reliability numerical rating scale—NRS) were collected by means of was analyzed using the intraclass correlation coeffi - an evaluation questionnaire prepared by the researchers. cient (ICC), followed by the Spearman correlation test NRS is a measure of pain intensity of 11 points (0–10). between the WHODAS 2.0 domain and total values Score zero means no pain and score 10 means worst found in the test and retest. This strategy of using two Barreto et al. Adv Rheumatol (2021) 61:58 Page 4 of 8 Table 1 Hypothesized correlations between the WHODAS along showed a moderate and significant correlation with 2.0 domains, total WHODAS 2.0 and the SF36, FIQ and BDI the total BDI value (Table 4). instruments Discussion WHODAS 2.0SF36FIQ BDI Our study showed that the WHODAS 2.0 is a valid and Cognition reliable instrument to measure functioning in individuals Mobility with FMS, presenting adequate psychometric properties. Self-Care The WHODAS 2.0 assesses functioning of individuals with FMS, incorporating aspects of health-related QoL, Getting along functional impact, and depressive symptoms. The WHO - Life activity DAS 2.0 offers the opportunity to evaluate the chronic Work activity patient, as in osteoarthritis[31] or rheumatoid arthritis, according to the ICF biopsychosocial model. Domestic activity The WHODAS 2.0 maintains excellent internal consist - Participation ency when evaluating individuals with FM. In this way, Total issues from the same domain and from the entire instru- ment are adequately related, and the interpretation of the scores reflects the level of functioning[32, 33]. Studies that evaluated the psychometric properties of the WHO- statistical tests is due to the nature of the tests in associa- DAS 2.0 in musculoskeletal and rheumatic conditions tion with the characteristics of FM. The ICC is a measure found similar results[34, 35]. of agreement. The correlation is considered strong when Additionally, our findings showed acceptable test– the value is higher than 0.7, moderate when it is between retest reliability but the domains of life activity and par- 0.4 and 0.7, and weak when it is less than 0.4[30]. We ticipation showed less stability in individuals with FMS verified the internal consistency according to Cronbach’s after one week. These results are probably due to FMS alpha. To assess the construct validity, we use the Spear- being a health condition with a wide variety of transient man correlation test between the domains and the total symptoms[13, 36], and changes may occur between two WHODAS 2.0 score, and FIQ and SF-36. time points. We hypothesize that the WHODAS 2.0 is capable of detecting minimal changes in these domains, Results however, the responsiveness of this instrument needs We evaluated 110 people with a diagnosis of FMS. The to be tested in a future study. The application of instru - participant data and the average value of the instruments ments addressing general health at the time of reapplica- are described in Table  2. The sample consisted primarily tion of the WHODAS 2.0 could confirm this hypothesis. of women (97.27%), aged 44.66 (± 14.69) years, who had The WHODAS 2.0 is an instrument that includes all paid work (21.82%) or were unemployed due to health ICF concepts for the evaluation of functioning[15]. Our problems (19.09%). The pain intensity level was 6.38 validation results reinforced the multidimensional nature (± 2.56). of this instrument, which covers part of the domains of The measures referring to the instrument’s psychomet - the three investigated instruments such as QoL, func- ric properties are described in Table  3. Results indicate tional impact and depressive symptoms. Additionally, the satisfactory values for internal consistency. In the test– WHODAS 2.0 covers other aspects not included in this retest reliability, we found between moderate to high ICC questionnaires[37]. The 12-item version WHODAS 2.0 values (except for life activities, whose work activities was related to fatigue, pain, sleep difficulties, cognitive were not responded by 57% of the sample), and the cor- impairment, depression, and social support in individuals relation coefficient was moderate to strong. with FMS[16]. In the construct validity analysis, the WHODAS 2.0 The scores of the investigated questionnaires were showed a moderate and significant correlation with the related to some of the WHODAS 2.0 domains. An SF-36, FIQ, and BDI. The WHODAS 2.0 domains, except example is FIQ, which had a moderate correlation with for the work activity domain, showed a moderate and sig- two WHODAS 2.0 domains, mobility and life activities nificant correlation with SF-36. The mobility domain and (domestic activity). These results demonstrated whereas domestic activity (life activities domain) of the WHO- FIQ is a specific instrument for assessing the health DAS 2.0 showed a moderate and significant correlation impact of individuals with FM[21], it fails to evaluate with the FIQ, and the domains of cognition and getting other functioning related domains such as cognition, self-care, and getting along. According to Prodinger et al. Bar reto et al. Adv Rheumatol (2021) 61:58 Page 5 of 8 Table 2 Description of the sociodemographic, clinical, and functional characteristics Variable n % (100) Sex Woman 107 92.27 Man 3 2.73 Marital status Never married 38 34.86 Currently married 42 38.53 Separated 9 8.26 Divorced 15 13.76 Widower 3 2.75 Cohabiting 2 1.83 Race White 14 16.86 Brown 35 42.16 Negro 30 36.14 Indigenous 4 4.82 Income Less than 1 minimum Brazilian wage 15 18.07 1–2 minimum Brazilian wage 38 45.78 3–5 minimum Brazilian wage 23 27.72 More than 5 minimum Brazilian wage 7 8.43 Work activity Paid work 24 21.82 Freelance 13 11.82 Non-paid work, such as volunteer or charity 2 1.82 Student 11 10 Homemaker 14 12.73 Retired 12 10.91 Unemployed (health reasons) 21 19.09 Unemployed (other reasons) 5 4.54 Other 8 7.27 Mean Standard deviation Age 44.66 14.69 How many years spent studying 16.10 8.83 NRS 6.38 2.56 FIQ 6.73 1.55 BDI 22.59 10.21 WHODAS 2.0 Cognition 43.63 20.23 Mobility 55.73 20.72 Self-care 27.18 22.67 Getting along 32.04 23.52 Life activity 46.70 21.62 Domestic activity 7.1.54 22.14 Work activity 60.10 20.56 Participation 55.00 19.92 Total 44.97 14.93 SF36 Physical functioning 36.10 17.70 Role physical 17.65 21.04 Barreto et al. Adv Rheumatol (2021) 61:58 Page 6 of 8 Table 2 (continued) Mean Standard deviation Bodily pain 23.45 20.25 General health 37.97 23.13 Vitality 24.93 21.63 Social functioning 39.95 23.41 Role emotional 29.37 34.15 Mental health 49.85 22.02 Total 32.92 12.53 Value referring to 83 individuals with FMS. NRS = Numeric Rating Scale; FIQ = Fibromyalgia Impact Questionnaire; WHODAS = World Health Organization Disability Assessment Schedule; SF36 = Medical Outcomes Study 36- Item Short-Form Health Survey; BDI = Beck Depression Index Table 3 Reliability (Cronbach’s α and ICC) of the WHODAS 2.0 domains Domains WHODAS 2.0 Cronbach’s α ICC (95%) Test–retest correlation coefficient Cognition 0.77 0.61 (0.34–0.87) 0.83* Mobility 0.81 0.79 (0.40- 0.95) 0.90* Self-care 0.76 0.67 (0.40 – 0.95) 0.79* Getting along 0.73 0.67 (0.41–0.93) 0.65* Life activity 0.44 0.41 (0.07- 0.74) 0.62* Domestic activity 0.62 0.31(0.00–0.67) 0.65* Work activity 0.53 0.49 (0.06–0.92) 0.58* Participation 0.80 0.26 (0.00–0.60) 0.59* Total 0.91 0.54 (0.13–0.95) 0.84* p < 0.05; WHODAS = World Health Organization Disability Assessment Schedule Table 4 Correlation coefficient matrix between the domains of WHODAS 2.0, SF36, BDI and FIQ WHODAS 2.0 Domains Cognition Mobility Self-care Getting along Life activity Work activity Domestic Participation Total activity SF 36 SF36 Total − 0.4055* − 0.4716* − 0.5394* − 0.5462* − 0.4436* − 0.2242 − 0.5522* − 0.4819* − 0.6435* Physical Function- − 0.3403* − 0.5581* − 0.4397* − 0.2362 − 0.4917* − 0.3756* − 0.4509* − 0.2828* − 0.4894* ing Role Physical − 0.1648 − 0.2165 − 0.3209* − 0.2201 − 0.2657 − 0.0394 − 0.4692* − 0.3264* − 0.3301* Bodily Pain − 0.1658 − 0.1783 − 0.0933 0.0319 − 0.1750 − 0.0431 − 0.2258 − 0.0593 − 0,2001* General Health − 0.2017 − 0.3715* − 0.5347* − 0.3230* − 0.4297* − 0.2075 − 0.5094* − 0.3377* − 0.4483* Vitality − 0.2821* − 0.3880* − 0.3269* − 0.1622 − 0.1715 − 0.0124 − 0.3146* − 0.3150* − 0.4100* Social Function- − 0.3268* − 0.2279 − 0.1436 − 0.3691* − 0.2875* − 0.2328 − 0.2485 − 0.2066 − 0.3664* ing Role Emotional − 0.0244 − 0.0095 − 0.2995* − 0.3411* − 0.1032 − 0.0236 − 0.1586 − 0.0353 − 0.1165 Mental Health − 0.3287* − 0.2005 − 0.0588 − 0.3317* − 0.1434 − 0.1130 − 0.1517 − 0.2844* − 0.2832* FIQ 0.3419* 0.4355* 0.3105* 0.1857 0.3894* 0.1833 0.4640* 0.3615 0.4857* BDI 0.5005* 0.3767* 0.2828 0.5276* 0.2643 0.2528 0.2387 0.2866 0.4616* p < 0.05; FIQ = Fibromyalgia Impact Questionnaire; WHODAS = World Health Organization Disability Assessment Schedule; SF36 = Medical Outcomes Study 36- Item Short-Form Health Survey; BDI = Beck Depression Index [38], a specific instrument might raise difficulties asso - 2.0 domains allows to identify typical disabilities of the ciated with the multidimensionality and functioning. FMS[3], which cannot be performed in the 12-item ver- This more detailed analysis according to the WHODAS sion of WHODAS[15]. Bar reto et al. Adv Rheumatol (2021) 61:58 Page 7 of 8 We observed that higher scores on health-related QoL on our findings we recommend using the instrument to were related to a better functioning profile in WHO - assess health status and to monitor health interventions. DAS 2.0. The total score of the SF-36 showed moderate correlation in 7 of the 8 domains of the WHODAS 2.0. Abbreviations However, neither the mental health, role emotional nor FMS: Fibromyalgia syndrome; QoL: Quality of life; ICF: International clas- the bodily pain SF-36 domains seem to be well explored sification of functioning, disability and health; WHODAS 2.0: World health organization disability assessment schedule 2.0; FIQ: Fibromyalgia Impact in WHODAS 2.0. These findings support the use of the Questionnaire; SF-36: Medical outcomes study 36-item short-form health sur- SF-36 as an outcome which complements WHODAS 2.0, vey; BDI: Beck depression inventory; NRS: Numerical rating scale; ICC: Intraclass as suggested Garin et  al.[35], who correlated the WHO- correlation coefficient. DAS 2.0 with the SF-36 for individuals with different Acknowledgements chronic diseases, and showed a moderate correlation in To the Movement project of the Department of Physiotherapy, Federal Univer- all analyses. Xenouli et al.[39] divided the SF-36 domains sity of Ceará. into two blocks, physical and mental health, and cor- Authors’ contributions related them with the total value of the WHODAS 2.0. MCAB collected data, contributed to the writing of the article, statistical The correlation between the total score of the WHO - analysis and final review; FRJM contributed to data collection, article writing and final review; CVG contributed to data collection and final review; CCL DAS 2.0 and the physical health SF-36 component was contributed to the writing of the article and final review; SSC performed the strong (r = –0.76) in Greeks with or without disabilities, statistical analysis, contributed to the writing of the article and final review; while the correlation was moderate between the WHO- ACLN supervised the project, contributed to data collection, statistical analysis, article writing and final review. All authors read and approved the final DAS 2.0 and the SF-36 mental health component (–0.50) manuscript. [39]. SF-36 was chosen because it is a generic question- naire that makes a global analysis of the QoL of the Funding This research did not receive any specific grant from funding agencies in the individual[22]. public, commercial, or not-for-profit sectors. The moderate correlation between BDI and WHO - DAS 2.0 suggests that important aspects of depressive Availability of data and materials The datasets used and/or analyzed during the current study are available from symptoms are covered in this functioning tool, especially the corresponding author on reasonable request. through the domains of cognition, mobility and getting along with people. Still it SF-36 and the BDI assess differ - Declarations ent outcomes when compared to the WHODAS 2.0[22, 23]. In addition, the instruments refer to different peri - Ethics approval and consent to participate This study was approved by the Research Ethics Committee of the University ods of symptom presentation, which can influence the of Triângulo Mineiro (1.918.391). patient’s report[21, 23]. Still, these instruments were included because they are the most used to assess indi- Consent for publication Not applicable. viduals with FMS. Our study is the first to investigate the correlation of the WHODAS 2.0 with FIQ and BDI. Competing interests We had some limitations in this study. We did not The authors declare that they have no competing interests. reapply a concurrent instrument at the time of the sec- Author details ond application of the WHODAS 2.0, which limits the 1 Department of Public Health, Universidade Federal do Ceará, Ceará, Fortaleza, perception of individual conditions on the day of the Brazil. 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Journal

Advances in Rheumatology – Springer Journals

Published: Sep 16, 2021

Keywords: Fibromyalgia syndrome; Disability; Chronic pain; Patient reported outcome measures; WHO

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