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Immediate Sequential Bilateral Cataract Surgery: Opinions among Refractive Surgeons in the United States and a Comparative Analysis with European Consultants

Immediate Sequential Bilateral Cataract Surgery: Opinions among Refractive Surgeons in the United... Hindawi Journal of Ophthalmology Volume 2022, Article ID 8310921, 6 pages https://doi.org/10.1155/2022/8310921 Research Article ImmediateSequentialBilateral Cataract Surgery:Opinionsamong Refractive Surgeons in the United States and a Comparative Analysis with European Consultants 1,2 2 3 4 Sloan W. Rush , Andres E. Guerrero Criado, Guy M. Kezirian, and Daniel Durrie Panhandle Eye Group, 7400 Fleming, Amarillo 79106, TX, USA Texas Tech University Health Science Center, 1400 S. Coulter, Amarillo 79106, TX, USA 3 th SurgiVision Consultants, 28071 N. 90 Way, Scottsdale 85262, AZ, USA Durrie Vision, 8300 College Blvd Suite 201, Overland Park 66210, KS, USA Correspondence should be addressed to Sloan W. Rush; sloan.rush@paneye.com Received 1 June 2022; Revised 17 August 2022; Accepted 23 August 2022; Published 5 September 2022 Academic Editor: Miguel Teus Copyright © 2022 Sloan W. Rush et al. �is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Purpose. To analyze the perspectives of practicing refractive surgeons regarding the implementation of Immediate Sequential Bilateral Cataract Surgery (ISBCS) in the United States (US) and to compare their perspectives with those of European colleagues. Setting. Online refractive surgery forum. Design. A survey-based questionnaire. Methods. An electronic survey was emailed to all surgeon members of the Refractive Surgery Alliance (RSA) in the US. Participants were prompted to score their impressions regarding various aspects regarding ISBCS. Responses were compared to published reports conducted among European surgeons. Results. �e electronic link to the survey was emailed to US-based surgeon members of the RSA, where 107 participated (44.6%). Twenty-seven (25.2%) reported that they currently perform ISBCS. Twenty-three (22.5%) of the respondents indicated they felt ISCBCS should be o•ered as a standard of care for routine cataract surgery. For surgeons that do not perform ISBCS, the most important factors were related to medicolegal issues and decreased reimbursement, whereas evidence of e•ectiveness and complications related to ISBCS were less important. Compared to practitioners abroad, 67.2% of European ophthalmic surgeons, compared to 25.2% of US surgeons, perform ISBCS (p < 0.0001). Conclusions. While US refractive surgeons often perform bilateral corneal procedures, many signi—cant barriers exist to the widespread adoption of ISBCS. Concerns reported by US surgeons mirror those reported by surgeons in Europe. �e majority of the US refractive surgeons in this survey indicate that ISBCS should not be the standard of care in routine cases, with the prevailing reason being concerns about decreased physician reimbursement and potential medicolegal issues, not safety. that immediate sequential bilateral cataract surgery (ISBCS) 1. Introduction should be the standard of care [4], though there has always existed a strong opposing viewpoint and resistance to change Cataract surgery is the most common outpatient surgical procedure performed in the US. It is estimated that greater [5]. Numerous reports in both the US and abroad have than 24 million Americans have cataracts in one or both eyes, and this number is expected to double over the next 30 demonstrated the safety and e¡cacy of ISBCS [6, 7]. Safety years [1]. Currently, an estimated 3.5 million patients have concerns include risk for bilateral endophthalmitis, bilateral cataract surgery each year in the US [2] with the vast ma- toxic anterior segment syndrome (TASS), and inability to jority of them being performed in the context of delayed re—ne lens implant calculations for the fellow eye [8, 9], but sequential bilateral cataract surgery (DSBCS) [3]. DSBCS has these concerns have largely not been supported by —ndings been the standard of care since the inception of cataract in the literature when proper protocols are used [10–13]. surgery. But as early as 2012, some investigators have argued Patient bene—ts from ISBCS include more rapid binocular 2 Journal of Ophthalmology Table 1: Characteristics of survey respondents. vision recovery, a decreased number of office visits, and a decreased amount of travel time, whereas the healthcare Characteristics (n � 107) system benefits from decreased costs [14–16]. Even still, Northeast � 13.1 (14) some experts have cited the lack of strong enough evidence Midwest � 29.0 (31) as being a significant barrier for the implementation of Region of practice in the United States South � 32.7 (35) ISBCS as the standard of care [17, 18]. West � 24.3 (26) Outside of the US, investigators have determined many Other � 0.9 (1) nonfinancial reasons as to why widespread adoption of <5 years � 15.9 (17) ISBCS has been limited. 'ese practitioners have cited risks 5–10 years � 15.0 (16) Length of practice 11–25 years � 33.6 of endophthalmitis, medicolegal issues, incorrect intraocular (36) lens power calculation, and lack of board/society approval >25 years � 35.5 (38) [19–21]. Many of these same reasons are applicable to US Yes � 86.9 (93) surgeons as well, but the financial constraints may be unique Access to an ambulatory surgery center No � 13.1 (14) to the healthcare system in the US. Increasing costs asso- Yes � 22.4 (24) Practice office-based surgery ciated with the delivery of healthcare in the US are driving No � 77.6 (83) the demand to find more efficient ways to save costs. Data <100 �10.3 (11) have shown that the increasing financial strains associated 101–500 � 30.8 (33) with decreased physician reimbursement from Medicare are Annual number of cataract surgeries 501–1,000 � 30.8 (33) leading to more billing [22]. In this study, we evaluate the performed 1,001–2,000 �19.6 opinions among US surgeons with regards to both the safety (21) >2,000 � 8.4 (9) of ISBCS and the financial limitations present in the evolving US healthcare system and contrast them with those of Values are given in % and (n). European surgeons. alpha <0.05 level. Incomplete surveys were excluded from 2.Methods the analysis. 'e SRS Institutional Review Board (IRB00009122) ap- 3.Results proved this survey-based questionnaire that analyzed phy- sician responses and their viewpoints concerning ISBCS. All A total of 107 of 240 (44.6%) US-based surgeon members of elements of the study observed the principles of the Dec- the RSA completed the survey and were included in the laration of Helsinki and were with carried out with regards analysis. Of the respondents, 27 (25.2%) reported they to human research standards and regulations. currently perform ISBCS, 75 surgeons (70.1%) indicated they do not perform ISBCS, and 5 surgeons (4.7%) indicated they have discontinued performing ISBCS. 'e character- 2.1. Questionnaire Design and Distribution. 'e question- istics of the survey respondents indicated a wide range of naire was developed to mirror surveys that have been diversity without any notable geographic or length of performed among European consultants in previously practice predilection (Table 1). published studies to allow for a more accurate comparative analysis [20]. A link and QR code to the electronic survey was sent by e-mail to all surgeon members of the Refractive 3.1. Practitioners of ISBCS. 'ere were 29.9% (n � 32) of the Surgery Alliance (RSA) practicing medicine in the US. 'e survey respondents that have performed ISBCS in routine survey was conducted using cloud-based software from cases. 'e factors considered most important among this Research Electronic Data Capture (REDCap). Study par- cohort are that the surgeon has a low complication rate ticipants were prompted to score their impressions on a (75.0%) as well as multiple matters related to infection risk, Likert-based scale regarding various aspects regarding including surgeons/nurses regloving and regowning be- ISBCS. 'e replies were collected on a scaled score according tween eyes (87.5%), the patient’s being at low risk for in- to the respondent’s rated level of importance. 'e responses fection (78.1%), and the operating facility’s infection record were anonymously collected from the online software and (71.9%). Several factors unrelated to safety were regarded as maintained as confidential. less important, which included time savings and conve- nience for the patient (62.5%), reimbursement issues (46.9%), and cost savings for the healthcare system (34.4%). 2.2. Data Collection and Statistical Analysis. REDCap was 'e least important factor was having a second surgeon and used to create pie chart and bar graph computations of the scrub nurse for the second eye (0.0%). 'e summary of these survey responses. JMP 11 software from the SAS Institute findings is displayed in Table 2. (Cary, NC, USA) was used to generate percentages, means, and standard deviations. Contingency analysis with likeli- hood ratios was used to compare outcomes in this study and 3.2. Nonpractitioners of ISBCS. 'ere were 70.1% (n � 107) a similar study conducted among European consultants [20]. of the survey respondents that do not perform ISBCS in 'e results were considered statistically significant at the routine cases. Table 3 shows the distribution of responses Journal of Ophthalmology 3 Table 2: Aspects to consider among surgeons who have performed ISBCS. Very Quite Not Aspects for consideration (n � 32) Important important important important Surgeon and scrub nurse regown and reglove before surgery on the second eye 87.5 (28) 9.4 (3) 3.1 (1) 0 (0) Patient has no additional risk factors for endophthalmitis 78.1 (25) 12.5 (4) 6.3 (2) 3.1 (1) Facility’s infection record 71.9 (23) 18.8 (6) 0 (0) 9.4 (3) Have a second surgeon and scrub nurse for the second eye 0 (0) 0 (0) 3.1 (1) 96.9 (31) More cost-effective for the health system 34.4 (11) 28.1 (9) 18.8 (6) 18.8 (6) Better visual outcome for the patient 37.5 (12) 40.6 (13) 3.1 (1) 18.8 (6) More convenient for a patient with faster rehabilitation 62.5 (20) 25.0 (8) 3.1 (1) 9.4 (3) Reduced visits for patient time savings 62.5 (20) 25.0 (8) 6.3 (2) 6.3 (2) Saves time in clinic and operating room 46.9 (15) 34.4 (11) 3.1 (1) 15.6 (5) Exclusion of high-risk eyes 65.6 (21) 25.0 (8) 3.1 (1) 6.3 (2) Surgeon has a low complication rate 75.0 (24) 18.8 (6) 3.1 (1) 3.1 (1) Instruments have gone through different sterilization cycles 65.6 (21) 21.9 (7) 0 (0) 12.5 (4) Medicine, solutions, and cannulas come from different manufacturers or have 21.9 (7) 43.8 (14) 6.3 (2) 28.1 (9) different batch numbers Postoperative day 1 review by an ophthalmologist 37.5 (12) 28.1 (9) 15.6 (5) 18.8 (6) Reimbursement issues 46.9 (15) 40.6 (13) 6.3 (2) 6.3 (2) Values are given in % and (n). Table 3: Concerns among surgeons about not performing ISBCS. Concerns (n � 75) Very important Important Quite important Not important Risk for endophthalmitis 46.7 (35) 20.0 (15) 18.7 (14) 14.7 (11) Medicolegal issues should ISBCS go wrong 58.7 (44) 26.7 (20) 6.7 (5) 8.0 (6) Risk for incorrect IOL power calculation 21.3 (16) 25.3 (19) 25.3 (19) 28.0 (21) Insufficient facilities or support staff 8.0 (6) 6.7 (5) 13.3 (10) 72.0 (54) Lack of training 1.3 (1) 13.3 (10) 8.0 (6) 77.3 (58) No evidence of effectiveness 5.3 (4) 10.7 (8) 18.7 (14) 65.3 (49) Risk for postoperative cystoid macular edema 13.3 (10) 20.0 (15) 18.7 (14) 48.0 (36) Risk for retinal detachment 9.3 (7) 20.0 (15) 21.3 (16) 49.3 (37) Reimbursement issues 54.7 (41) 17.3 (13) 13.3 (10) 14.7 (11) Values are given in % and (n). Table 4: Circumstances that will positively influence the decision for routinely performing ISBCS. Circumstance (n � 107) Improved evidence of safety and effectiveness 41.1 (44) Medicolegal/indemnity insurance approval 65.4 (70) Specialist society or academy approval 38.3 (41) Availability of prepacked right eye/left eye instruments 32.7 (35) Improved availability of intracameral antibiotics 29.9 (32) Other 19.6 (21) I would not consider bilateral cataract surgery under any circumstances 12.1 (13) Values are given in % and (n). among these surgeons. 'e concerns regarded as most and effectiveness (41.1%), specialist society or academy important include medicolegal issues (58.7%), reimburse- approval (38.3%), availability of prepacked right eye/left eye ment issues (54.7%), and the risk of endophthalmitis instruments (32.7%), and improved availability of intra- (46.7%). 'e least important worries were lack of training cameral antibiotics (29.9%). 'irteen (12.1%) respondents stated that they would not perform ISBCS under any cir- (1.3%), lack of evidence regarding ISBCS efficacy (5.3%), and lack of available support staff (8.0%). cumstances. 'ese findings are given in Table 4. 3.3. Future Outlook for ISBCS. Medicolegal/indemnity in- 3.4. Comparative Analysis. Compared to practitioners surance approval was regarded as the most important cir- abroad, [20] 67.2% of European ophthalmic surgeons cumstance for all surgeons to routinely practice ISBCS as the compared to 25.2% of the US surgeons perform ISBCS standard of care (65.4% of respondents). Other less im- (p< 0.0001). Among those that do not perform ISBCS, two portant circumstances included improved evidence of safety of the most important factors among both US and European 4 Journal of Ophthalmology perform ISBCS. 'is disparity could possibly be explained by surgeons are the risk of endophthalmitis and medicolegal issues should ISBCS go wrong. With respect to risk for the decreased incidence of endophthalmitis reported in the US compared with Europe. [24, 25] 'ough commonly used endophthalmitis, 69.0% of European surgeons compared to 46.7% of US surgeons rate this factor as a very important in practice by many US surgeons, there is still a lack of an reason for not performing ISBCS (p � 0.006) and with re- FDA-approved intracameral antibiotic for infection pre- spect to medicolegal issues, 57.8% of European surgeons vention during cataract surgery. 'is conundrum persists compared to 58.7% of the US surgeons rate this factor as a due to the high costs associated with the FDA-approval very important reason for not performing ISBCS (p � 0.91). process, despite overwhelming evidence of its effectiveness. [26]. It is revealing that only 5.3% of surgeons not practicing 4.Discussion ISBCS cite a lack of evidence for the effectiveness of ISBCS as very important. 'is indicates that more peer-reviewed, 'is survey has explored the benefits, disadvantages, and barriers to adopting ISBCS as the standard of care practice published evidence may not have that large of an impact on the attitudes or beliefs about ISBCS among US surgeons. It among US surgeons. 'e majority of surgeons do not believe that ISBCS should be the standard of care for routine cat- would be of interest to see how removing the financial and aract surgery at this particular point in time. But their at- medicolegal obstacles may influence surgeon attitudes about titudes toward ISBCS are still favorable under the right ISBCS. 'ough not the only consideration, patient care circumstances, and ISBCS may become more accepted over should be prioritized above all else. Also, this survey does not time, as only 12.1% state that they would not ever consider capture any input from the patient, but it can be assumed ISBCS. 'e primary limiting factors are related to medi- that there would be time and cost savings as well as con- colegal and reimbursement issues, two reasons unrelated to venience for the patient in the setting of ISBCS. [27, 28] 'e patient care. Approximately half of both ISBCS practitioners surgeons performing ISBCS in this study indicated some concern about these issues. and nonpractitioners alike regarded reimbursement issues as very important, with no statistical significance between the Additional weaknesses of this study consist of its in- clusion of only physicians that identify as refractive surgeons two groups (p � 0.46). 'is finding suggests that reim- bursement is an obstacle even for those that routinely and may routinely be accustomed to practicing bilateral perform ISBCS and that they may be suffering financial surgery (as in the setting of corneal refractive procedures), consequences as a result of practicing ISBCS. the relatively small number of survey respondents, and the 'ere are a variety of practice settings that may influence potential for bias in an uncontrolled and unvalidated, Likert- reimbursement in the US. Practices that perform predom- based survey design. Additional research is warranted to inantly elective refractive lens exchange procedures or do further investigate the barriers and limitations that prevent more widespread use of ISBCS in the US. not accept medical insurance may have no financial con- sequences. Other settings that include academic medical practice, the Veteran’s Affairs healthcare system, and health Abbreviations management organization networks [8] may impose mini- mal financial barriers for the surgeon. By contrast, practices ISBCS: Immediate sequential bilateral cataract surgery that rely heavily on reimbursement from third-party payers, DSBCS: Delayed sequential bilateral cataract surgery including private insurance and Medicare, may experience RSA: Refractive surgery alliance. significant revenue loss when adopting ISBCS [14]. Both medicolegal and financial aspects in the US are likely to Data Availability evolve over time, which may positively influence the atti- tudes of surgeons regarding ISBCS. Physicians can inform 'e datasets used and/or analyzed during the current study policy-makers regarding the cost savings of ISBCS for the are available from the corresponding author upon reason- healthcare system while noting that a large decrease in able request. physician reimbursement will inhibit its practice and widespread adoption of ISBCS will mitigate many concerns related to medicolegal issues. Additional Points 'e largest barrier to routine ISBCS implementation that relates directly to patient care is a concern for endoph- Synopsis. 'e majority of surveyed surgeons indicate that thalmitis. Arshinoff et al. have developed safety guidelines ISBCS should not be the standard of care, with the prevailing when performing ISBCS [23]. When using published pro- reason being concerns about decreased reimbursement and tocols and treating both eyes as separate surgical events, the potential medicolegal issues, not safety. likelihood of bilateral simultaneous endophthalmitis is ex- ceedingly low. Reported cases have been the consequence of major breachs in sterile technique or otherwise substandard Ethical Approval surgical techniques [13]. Interestingly, US surgeons have less concern regarding the importance of endophthalmitis than 'e study was approved by the SRS Independent Review their European counterparts (p � 0.006), yet European Board in accordance with the Ethical Standards laid down in surgeons are still greater than 2.5 times more likely to the Declaration of Helsinki. Journal of Ophthalmology 5 cataract surgery,” JAMA Ophthalmol, vol. 139, no. 8, Disclosure pp. 876–885, 2021. rd [13] S. A. Arshinoff, C. Claoue, ´ C. Mehta, and B. Johanssen, 'is abstract was presented at the 33 Annual Student “Bilateral pseudomonas endophalmitis after immediately Research Week at Texas Tech University Health Sciences sequential bilateral cataract surgery,” Arquivos Brasileiros de Center, Lubbock, TX. Oftalmologia, vol. 82, no. 4, pp. 356-357, 2019. [14] S. W. Rush, A. E. Gerald, J. C. Smith, A. J. Rush, and Conflicts of Interest R. B. Rush, “Prospective analysis of outcomes and economic factors of same-day bilateral cataract surgery in the United 'e authors declare that there are no conflicts of interest. States,” Journal of Cataract and Refractive Surgery, vol. 41, no. 4, pp. 732–739, 2015. Authors’ Contributions [15] D. P. O’Brart, H. Roberts, K. Naderi, and J. Gormley, “Economic modelling of immediately sequential bilateral All authors participated in the study design and read and cataract surgery (ISBCS) in the National Health Service approved the final manuscript. based on possible improvements in surgical efficiency,” BMJ Open Ophthalmology, vol. 5, no. 1, Article ID e000426, References [16] S. Masket, “Same day bilateral cataract surgery-who benefits?” Ophthalmology, vol. 128, no. 1, pp. 11-12, 2021. [1] “National Institute of health/National eye Institute info- [17] L. Kessel, J. Andresen, D. Erngaard, P. Flesner, B. Tendal, and graphic NEI-medialibrary-3648301.jpg,” Online NIH.gov. J. Hjortdal, “Immediate sequential bilateral cataract surgery: a [2] S. Zafar, P. Wang, D. Srikumaran et al., “Billing of cataract systematic review and meta-analysis,” Journal of Ophthal- surgery as complex versus routine for Medicare beneficiaries,” Journal of Cataract and Refractive Surgery, vol. 45, no. 11, mology, vol. 2015, Article ID 912481, 11 pages, 2015. pp. 1547–1554, 2019. [18] V. C. Lansingh, K. A. Eckert, and G. Strauss, “Benefits and [3] K. M. Miller and T. A. Oetting, “Cataract in the adult eye risks of immediately sequential bilateral cataract surgery: a PPP,” 2021, https://www.aao.org/preferred-practice-pattern/ literature review,” Clinical and Experimental Ophthalmology, cataract-in-adult-eye-ppp-2021-in-press. vol. 43, no. 7, pp. 666–672, 2015. [4] S. A. Arshinoff, “Same-day cataract surgery should be the [19] E. Lee, B. Balasingam, E. C. Mills, M. Zarei-Ghanavati, and standard of care for patients with bilateral visually significant C. 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Immediate Sequential Bilateral Cataract Surgery: Opinions among Refractive Surgeons in the United States and a Comparative Analysis with European Consultants

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Copyright © 2022 Sloan W. Rush et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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Abstract

Hindawi Journal of Ophthalmology Volume 2022, Article ID 8310921, 6 pages https://doi.org/10.1155/2022/8310921 Research Article ImmediateSequentialBilateral Cataract Surgery:Opinionsamong Refractive Surgeons in the United States and a Comparative Analysis with European Consultants 1,2 2 3 4 Sloan W. Rush , Andres E. Guerrero Criado, Guy M. Kezirian, and Daniel Durrie Panhandle Eye Group, 7400 Fleming, Amarillo 79106, TX, USA Texas Tech University Health Science Center, 1400 S. Coulter, Amarillo 79106, TX, USA 3 th SurgiVision Consultants, 28071 N. 90 Way, Scottsdale 85262, AZ, USA Durrie Vision, 8300 College Blvd Suite 201, Overland Park 66210, KS, USA Correspondence should be addressed to Sloan W. Rush; sloan.rush@paneye.com Received 1 June 2022; Revised 17 August 2022; Accepted 23 August 2022; Published 5 September 2022 Academic Editor: Miguel Teus Copyright © 2022 Sloan W. Rush et al. �is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Purpose. To analyze the perspectives of practicing refractive surgeons regarding the implementation of Immediate Sequential Bilateral Cataract Surgery (ISBCS) in the United States (US) and to compare their perspectives with those of European colleagues. Setting. Online refractive surgery forum. Design. A survey-based questionnaire. Methods. An electronic survey was emailed to all surgeon members of the Refractive Surgery Alliance (RSA) in the US. Participants were prompted to score their impressions regarding various aspects regarding ISBCS. Responses were compared to published reports conducted among European surgeons. Results. �e electronic link to the survey was emailed to US-based surgeon members of the RSA, where 107 participated (44.6%). Twenty-seven (25.2%) reported that they currently perform ISBCS. Twenty-three (22.5%) of the respondents indicated they felt ISCBCS should be o•ered as a standard of care for routine cataract surgery. For surgeons that do not perform ISBCS, the most important factors were related to medicolegal issues and decreased reimbursement, whereas evidence of e•ectiveness and complications related to ISBCS were less important. Compared to practitioners abroad, 67.2% of European ophthalmic surgeons, compared to 25.2% of US surgeons, perform ISBCS (p < 0.0001). Conclusions. While US refractive surgeons often perform bilateral corneal procedures, many signi—cant barriers exist to the widespread adoption of ISBCS. Concerns reported by US surgeons mirror those reported by surgeons in Europe. �e majority of the US refractive surgeons in this survey indicate that ISBCS should not be the standard of care in routine cases, with the prevailing reason being concerns about decreased physician reimbursement and potential medicolegal issues, not safety. that immediate sequential bilateral cataract surgery (ISBCS) 1. Introduction should be the standard of care [4], though there has always existed a strong opposing viewpoint and resistance to change Cataract surgery is the most common outpatient surgical procedure performed in the US. It is estimated that greater [5]. Numerous reports in both the US and abroad have than 24 million Americans have cataracts in one or both eyes, and this number is expected to double over the next 30 demonstrated the safety and e¡cacy of ISBCS [6, 7]. Safety years [1]. Currently, an estimated 3.5 million patients have concerns include risk for bilateral endophthalmitis, bilateral cataract surgery each year in the US [2] with the vast ma- toxic anterior segment syndrome (TASS), and inability to jority of them being performed in the context of delayed re—ne lens implant calculations for the fellow eye [8, 9], but sequential bilateral cataract surgery (DSBCS) [3]. DSBCS has these concerns have largely not been supported by —ndings been the standard of care since the inception of cataract in the literature when proper protocols are used [10–13]. surgery. But as early as 2012, some investigators have argued Patient bene—ts from ISBCS include more rapid binocular 2 Journal of Ophthalmology Table 1: Characteristics of survey respondents. vision recovery, a decreased number of office visits, and a decreased amount of travel time, whereas the healthcare Characteristics (n � 107) system benefits from decreased costs [14–16]. Even still, Northeast � 13.1 (14) some experts have cited the lack of strong enough evidence Midwest � 29.0 (31) as being a significant barrier for the implementation of Region of practice in the United States South � 32.7 (35) ISBCS as the standard of care [17, 18]. West � 24.3 (26) Outside of the US, investigators have determined many Other � 0.9 (1) nonfinancial reasons as to why widespread adoption of <5 years � 15.9 (17) ISBCS has been limited. 'ese practitioners have cited risks 5–10 years � 15.0 (16) Length of practice 11–25 years � 33.6 of endophthalmitis, medicolegal issues, incorrect intraocular (36) lens power calculation, and lack of board/society approval >25 years � 35.5 (38) [19–21]. Many of these same reasons are applicable to US Yes � 86.9 (93) surgeons as well, but the financial constraints may be unique Access to an ambulatory surgery center No � 13.1 (14) to the healthcare system in the US. Increasing costs asso- Yes � 22.4 (24) Practice office-based surgery ciated with the delivery of healthcare in the US are driving No � 77.6 (83) the demand to find more efficient ways to save costs. Data <100 �10.3 (11) have shown that the increasing financial strains associated 101–500 � 30.8 (33) with decreased physician reimbursement from Medicare are Annual number of cataract surgeries 501–1,000 � 30.8 (33) leading to more billing [22]. In this study, we evaluate the performed 1,001–2,000 �19.6 opinions among US surgeons with regards to both the safety (21) >2,000 � 8.4 (9) of ISBCS and the financial limitations present in the evolving US healthcare system and contrast them with those of Values are given in % and (n). European surgeons. alpha <0.05 level. Incomplete surveys were excluded from 2.Methods the analysis. 'e SRS Institutional Review Board (IRB00009122) ap- 3.Results proved this survey-based questionnaire that analyzed phy- sician responses and their viewpoints concerning ISBCS. All A total of 107 of 240 (44.6%) US-based surgeon members of elements of the study observed the principles of the Dec- the RSA completed the survey and were included in the laration of Helsinki and were with carried out with regards analysis. Of the respondents, 27 (25.2%) reported they to human research standards and regulations. currently perform ISBCS, 75 surgeons (70.1%) indicated they do not perform ISBCS, and 5 surgeons (4.7%) indicated they have discontinued performing ISBCS. 'e character- 2.1. Questionnaire Design and Distribution. 'e question- istics of the survey respondents indicated a wide range of naire was developed to mirror surveys that have been diversity without any notable geographic or length of performed among European consultants in previously practice predilection (Table 1). published studies to allow for a more accurate comparative analysis [20]. A link and QR code to the electronic survey was sent by e-mail to all surgeon members of the Refractive 3.1. Practitioners of ISBCS. 'ere were 29.9% (n � 32) of the Surgery Alliance (RSA) practicing medicine in the US. 'e survey respondents that have performed ISBCS in routine survey was conducted using cloud-based software from cases. 'e factors considered most important among this Research Electronic Data Capture (REDCap). Study par- cohort are that the surgeon has a low complication rate ticipants were prompted to score their impressions on a (75.0%) as well as multiple matters related to infection risk, Likert-based scale regarding various aspects regarding including surgeons/nurses regloving and regowning be- ISBCS. 'e replies were collected on a scaled score according tween eyes (87.5%), the patient’s being at low risk for in- to the respondent’s rated level of importance. 'e responses fection (78.1%), and the operating facility’s infection record were anonymously collected from the online software and (71.9%). Several factors unrelated to safety were regarded as maintained as confidential. less important, which included time savings and conve- nience for the patient (62.5%), reimbursement issues (46.9%), and cost savings for the healthcare system (34.4%). 2.2. Data Collection and Statistical Analysis. REDCap was 'e least important factor was having a second surgeon and used to create pie chart and bar graph computations of the scrub nurse for the second eye (0.0%). 'e summary of these survey responses. JMP 11 software from the SAS Institute findings is displayed in Table 2. (Cary, NC, USA) was used to generate percentages, means, and standard deviations. Contingency analysis with likeli- hood ratios was used to compare outcomes in this study and 3.2. Nonpractitioners of ISBCS. 'ere were 70.1% (n � 107) a similar study conducted among European consultants [20]. of the survey respondents that do not perform ISBCS in 'e results were considered statistically significant at the routine cases. Table 3 shows the distribution of responses Journal of Ophthalmology 3 Table 2: Aspects to consider among surgeons who have performed ISBCS. Very Quite Not Aspects for consideration (n � 32) Important important important important Surgeon and scrub nurse regown and reglove before surgery on the second eye 87.5 (28) 9.4 (3) 3.1 (1) 0 (0) Patient has no additional risk factors for endophthalmitis 78.1 (25) 12.5 (4) 6.3 (2) 3.1 (1) Facility’s infection record 71.9 (23) 18.8 (6) 0 (0) 9.4 (3) Have a second surgeon and scrub nurse for the second eye 0 (0) 0 (0) 3.1 (1) 96.9 (31) More cost-effective for the health system 34.4 (11) 28.1 (9) 18.8 (6) 18.8 (6) Better visual outcome for the patient 37.5 (12) 40.6 (13) 3.1 (1) 18.8 (6) More convenient for a patient with faster rehabilitation 62.5 (20) 25.0 (8) 3.1 (1) 9.4 (3) Reduced visits for patient time savings 62.5 (20) 25.0 (8) 6.3 (2) 6.3 (2) Saves time in clinic and operating room 46.9 (15) 34.4 (11) 3.1 (1) 15.6 (5) Exclusion of high-risk eyes 65.6 (21) 25.0 (8) 3.1 (1) 6.3 (2) Surgeon has a low complication rate 75.0 (24) 18.8 (6) 3.1 (1) 3.1 (1) Instruments have gone through different sterilization cycles 65.6 (21) 21.9 (7) 0 (0) 12.5 (4) Medicine, solutions, and cannulas come from different manufacturers or have 21.9 (7) 43.8 (14) 6.3 (2) 28.1 (9) different batch numbers Postoperative day 1 review by an ophthalmologist 37.5 (12) 28.1 (9) 15.6 (5) 18.8 (6) Reimbursement issues 46.9 (15) 40.6 (13) 6.3 (2) 6.3 (2) Values are given in % and (n). Table 3: Concerns among surgeons about not performing ISBCS. Concerns (n � 75) Very important Important Quite important Not important Risk for endophthalmitis 46.7 (35) 20.0 (15) 18.7 (14) 14.7 (11) Medicolegal issues should ISBCS go wrong 58.7 (44) 26.7 (20) 6.7 (5) 8.0 (6) Risk for incorrect IOL power calculation 21.3 (16) 25.3 (19) 25.3 (19) 28.0 (21) Insufficient facilities or support staff 8.0 (6) 6.7 (5) 13.3 (10) 72.0 (54) Lack of training 1.3 (1) 13.3 (10) 8.0 (6) 77.3 (58) No evidence of effectiveness 5.3 (4) 10.7 (8) 18.7 (14) 65.3 (49) Risk for postoperative cystoid macular edema 13.3 (10) 20.0 (15) 18.7 (14) 48.0 (36) Risk for retinal detachment 9.3 (7) 20.0 (15) 21.3 (16) 49.3 (37) Reimbursement issues 54.7 (41) 17.3 (13) 13.3 (10) 14.7 (11) Values are given in % and (n). Table 4: Circumstances that will positively influence the decision for routinely performing ISBCS. Circumstance (n � 107) Improved evidence of safety and effectiveness 41.1 (44) Medicolegal/indemnity insurance approval 65.4 (70) Specialist society or academy approval 38.3 (41) Availability of prepacked right eye/left eye instruments 32.7 (35) Improved availability of intracameral antibiotics 29.9 (32) Other 19.6 (21) I would not consider bilateral cataract surgery under any circumstances 12.1 (13) Values are given in % and (n). among these surgeons. 'e concerns regarded as most and effectiveness (41.1%), specialist society or academy important include medicolegal issues (58.7%), reimburse- approval (38.3%), availability of prepacked right eye/left eye ment issues (54.7%), and the risk of endophthalmitis instruments (32.7%), and improved availability of intra- (46.7%). 'e least important worries were lack of training cameral antibiotics (29.9%). 'irteen (12.1%) respondents stated that they would not perform ISBCS under any cir- (1.3%), lack of evidence regarding ISBCS efficacy (5.3%), and lack of available support staff (8.0%). cumstances. 'ese findings are given in Table 4. 3.3. Future Outlook for ISBCS. Medicolegal/indemnity in- 3.4. Comparative Analysis. Compared to practitioners surance approval was regarded as the most important cir- abroad, [20] 67.2% of European ophthalmic surgeons cumstance for all surgeons to routinely practice ISBCS as the compared to 25.2% of the US surgeons perform ISBCS standard of care (65.4% of respondents). Other less im- (p< 0.0001). Among those that do not perform ISBCS, two portant circumstances included improved evidence of safety of the most important factors among both US and European 4 Journal of Ophthalmology perform ISBCS. 'is disparity could possibly be explained by surgeons are the risk of endophthalmitis and medicolegal issues should ISBCS go wrong. With respect to risk for the decreased incidence of endophthalmitis reported in the US compared with Europe. [24, 25] 'ough commonly used endophthalmitis, 69.0% of European surgeons compared to 46.7% of US surgeons rate this factor as a very important in practice by many US surgeons, there is still a lack of an reason for not performing ISBCS (p � 0.006) and with re- FDA-approved intracameral antibiotic for infection pre- spect to medicolegal issues, 57.8% of European surgeons vention during cataract surgery. 'is conundrum persists compared to 58.7% of the US surgeons rate this factor as a due to the high costs associated with the FDA-approval very important reason for not performing ISBCS (p � 0.91). process, despite overwhelming evidence of its effectiveness. [26]. It is revealing that only 5.3% of surgeons not practicing 4.Discussion ISBCS cite a lack of evidence for the effectiveness of ISBCS as very important. 'is indicates that more peer-reviewed, 'is survey has explored the benefits, disadvantages, and barriers to adopting ISBCS as the standard of care practice published evidence may not have that large of an impact on the attitudes or beliefs about ISBCS among US surgeons. It among US surgeons. 'e majority of surgeons do not believe that ISBCS should be the standard of care for routine cat- would be of interest to see how removing the financial and aract surgery at this particular point in time. But their at- medicolegal obstacles may influence surgeon attitudes about titudes toward ISBCS are still favorable under the right ISBCS. 'ough not the only consideration, patient care circumstances, and ISBCS may become more accepted over should be prioritized above all else. Also, this survey does not time, as only 12.1% state that they would not ever consider capture any input from the patient, but it can be assumed ISBCS. 'e primary limiting factors are related to medi- that there would be time and cost savings as well as con- colegal and reimbursement issues, two reasons unrelated to venience for the patient in the setting of ISBCS. [27, 28] 'e patient care. Approximately half of both ISBCS practitioners surgeons performing ISBCS in this study indicated some concern about these issues. and nonpractitioners alike regarded reimbursement issues as very important, with no statistical significance between the Additional weaknesses of this study consist of its in- clusion of only physicians that identify as refractive surgeons two groups (p � 0.46). 'is finding suggests that reim- bursement is an obstacle even for those that routinely and may routinely be accustomed to practicing bilateral perform ISBCS and that they may be suffering financial surgery (as in the setting of corneal refractive procedures), consequences as a result of practicing ISBCS. the relatively small number of survey respondents, and the 'ere are a variety of practice settings that may influence potential for bias in an uncontrolled and unvalidated, Likert- reimbursement in the US. Practices that perform predom- based survey design. Additional research is warranted to inantly elective refractive lens exchange procedures or do further investigate the barriers and limitations that prevent more widespread use of ISBCS in the US. not accept medical insurance may have no financial con- sequences. Other settings that include academic medical practice, the Veteran’s Affairs healthcare system, and health Abbreviations management organization networks [8] may impose mini- mal financial barriers for the surgeon. By contrast, practices ISBCS: Immediate sequential bilateral cataract surgery that rely heavily on reimbursement from third-party payers, DSBCS: Delayed sequential bilateral cataract surgery including private insurance and Medicare, may experience RSA: Refractive surgery alliance. significant revenue loss when adopting ISBCS [14]. Both medicolegal and financial aspects in the US are likely to Data Availability evolve over time, which may positively influence the atti- tudes of surgeons regarding ISBCS. Physicians can inform 'e datasets used and/or analyzed during the current study policy-makers regarding the cost savings of ISBCS for the are available from the corresponding author upon reason- healthcare system while noting that a large decrease in able request. physician reimbursement will inhibit its practice and widespread adoption of ISBCS will mitigate many concerns related to medicolegal issues. Additional Points 'e largest barrier to routine ISBCS implementation that relates directly to patient care is a concern for endoph- Synopsis. 'e majority of surveyed surgeons indicate that thalmitis. Arshinoff et al. have developed safety guidelines ISBCS should not be the standard of care, with the prevailing when performing ISBCS [23]. When using published pro- reason being concerns about decreased reimbursement and tocols and treating both eyes as separate surgical events, the potential medicolegal issues, not safety. likelihood of bilateral simultaneous endophthalmitis is ex- ceedingly low. Reported cases have been the consequence of major breachs in sterile technique or otherwise substandard Ethical Approval surgical techniques [13]. Interestingly, US surgeons have less concern regarding the importance of endophthalmitis than 'e study was approved by the SRS Independent Review their European counterparts (p � 0.006), yet European Board in accordance with the Ethical Standards laid down in surgeons are still greater than 2.5 times more likely to the Declaration of Helsinki. Journal of Ophthalmology 5 cataract surgery,” JAMA Ophthalmol, vol. 139, no. 8, Disclosure pp. 876–885, 2021. rd [13] S. A. Arshinoff, C. Claoue, ´ C. Mehta, and B. Johanssen, 'is abstract was presented at the 33 Annual Student “Bilateral pseudomonas endophalmitis after immediately Research Week at Texas Tech University Health Sciences sequential bilateral cataract surgery,” Arquivos Brasileiros de Center, Lubbock, TX. Oftalmologia, vol. 82, no. 4, pp. 356-357, 2019. [14] S. W. Rush, A. E. Gerald, J. C. Smith, A. J. Rush, and Conflicts of Interest R. B. Rush, “Prospective analysis of outcomes and economic factors of same-day bilateral cataract surgery in the United 'e authors declare that there are no conflicts of interest. States,” Journal of Cataract and Refractive Surgery, vol. 41, no. 4, pp. 732–739, 2015. Authors’ Contributions [15] D. P. O’Brart, H. Roberts, K. Naderi, and J. 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Published: Sep 5, 2022

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