Risk of bias analysis in diabetic retinopathy randomized clinical trials evaluated by RoB-1 tool from Cochrane systematic reviews
DOI:
https://doi.org/10.17267/2675-021Xevidence.2022.e3791Keywords:
Diabetic Retinopathy, Diabetic macular edema, Risk of Bias, Randomized Controlled Trials as TopicAbstract
The objective of clinical trials is to answer about intervention in the real-world, for which they must be properly designed and executed by presenting the results reliably with the findings and in a clear way. OBJECTIVES: To identify the risk of bias in clinical trials about interventions for diabetic retinopathy and/or diabetic macular edema from Cochrane systematic reviews. METHODS: A sensitive search strategy was designed to search Cochrane systematic reviews of interventions in diabetic retinopathy and diabetic macular edema. The assessment of the risk of bias was captured as presented by the author. FINDINGS: We found eight SR and one meta-analysis network totaling 116 randomized clinical trials. Our sample revealed that among the domains randomization, allocation secret, masking of participants and personnel, incomplete outcomes, selective outcomes and others, the risk of bias assessed as low ranged from 30.4 to 49.1%; unclear risk between 22 to 56% and high risk from 1 to 21.7%. CONCLUSIONS: The risk of bias in diabetic retinopathy randomized clinical trials exists in high frequency and the reader must be aware of it.
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Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010;376(9735):124-36. https://doi.org/10.1016/S0140-6736(09)62124-3
Zheng Y, He M, Congdon N. The worldwide epidemic of diabetic retinopathy. Indian J Ophthalmol. 2012;60(5):428-31. https://doi.org/10.4103/0301-4738.100542
Lee R, Wong TY, Sabanayagam C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis (Lond). 2015;2:17. https://doi.org/10.1186/s40662-015-0026-2
Dong Y, Liu Y, Yu J, Qi S, Liu H. Mapping research trends in diabetic retinopathy from 2010 to 2019: A bibliometric analysis. Medicine (Baltimore). 2021;100(3):e23981. https://doi.org/10.1097/md.0000000000023981
AlRyalat SA, Abukahel A, Elubous KA. Randomized controlled trials in ophthalmology: a bibliometric study. F1000Res. 2019;8:1718. https://doi.org/10.12688/f1000research.20673.1
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. https://doi.org/10.1136/bmj.c869
Boutron I, Page MJ, Higgins JPT, Altman DG, Lundh A, Hróbjartsson A. Chapter 7: Considering bias and conflicts of interest among the included studies [Internet]. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.2 (updated February 2021). London: Cochrane; 2021. Available from: www.training.cochrane.org/handbook
Savovi? J, Jones HE, Altman DG, Harris RJ, Jüni P, Pildal J, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med. 2012;157(6):429-38. https://doi.org/10.7326/0003-4819-157-6-201209180-00537
Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.2 (updated February 2021) [Internet]. London: Cochrane; 2021. Available from: www.training.cochrane.org/handbook
Sterne JAC, Savovi? J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898. https://doi.org/10.1136/bmj.l4898
Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2012;12:MR000033. https://doi.org/10.1002/14651858.mr000033.pub2
Dechartres A, Boutron I, Trinquart L, Charles P, Ravaud P. Single-center trials show larger treatment effects than multicenter trials: evidence from a meta-epidemiologic study. Ann Intern Med. 2011;155(1):39–51. https://doi.org/10.7326/0003-4819-155-1-201107050-00006
Panagiotou OA, Contopoulos-Ioannidis DG, Ioannidis JP. Comparative effect sizes in randomised trials from less developed and more developed countries: meta-epidemiological assessment. BMJ. 2013;346:f707. https://doi.org/10.1136/bmj.f707
Bassler D, Briel M, Montori VM, Lane M, Glasziou P, Zhou Q, et al. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA. 2010;303(12):1180–7. https://doi.org/10.1001/jama.2010.310
Smith JM, Steel DHW. Anti-vascular endothelial growth factor for prevention of postoperative vitreous cavity haemorrhage after vitrectomy for proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2015;2015(8):CD008214. Cited: PMID: 26250103
Evans JR, Michelessi M, Virgili G. Laser photocoagulation for proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2014 Nov 24;2014(11):CD011234. https://doi.org/10.1002/14651858.cd011234.pub2
Martinez-Zapata MJ, Martí-Carvajal AJ, Solà I, Pijoán JI, Buil-Calvo JA, Cordero JA, et al. Anti-vascular endothelial growth factor for proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2014 Nov 24;2014(11):CD008721. https://doi.org/10.1002/14651858.cd008721.pub2
Moutray T, Evans JR, Lois N, Armstrong DJ, Peto T, Azuara-Blanco A. Different lasers and techniques for proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2018 Mar 15;3(3):CD012314. https://doi.org/10.1002/14651858.cd012314.pub2
Mehta H, Hennings C, Gillies MC, Nguyen V, Campain A, Fraser-Bell S. Anti-vascular endothelial growth factor combined with intravitreal steroids for diabetic macular oedema. Cochrane Database Syst Rev. 2018 Apr 18;4(4):CD011599. https://doi.org/10.1002/14651858.cd011599.pub2
Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020;11(11):CD005656. https://doi.org/10.1002/14651858.cd005656.pub3
Jorge EC, Jorge EN, Botelho M, Farat JG, Virgili G, El Dib R. Monotherapy laser photocoagulation for diabetic macular oedema. Cochrane Database Syst Rev. 2018;10(10):CD010859. https://doi.org/10.1002/14651858.cd010859.pub2
Do DV, Wang X, Vedula SS, Marrone M, Sleilati G, Hawkins BS, et al. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2015;1:CD006127. Cited: PMID: 25637717
Virgili G, Parravano M, Evans JR, Gordon I, Lucenteforte E. Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis. Cochrane Database Syst Rev. 2017;6(6):CD007419. https://doi.org/10.1002/14651858.cd007419.pub5
Hróbjartsson A, Boutron I, Turner L, Altman DG, Moher D; Cochrane Bias Methods Group. Assessing risk of bias in randomised clinical trials included in Cochrane Reviews: the why is easy, the how is a challenge. Cochrane Database Syst Rev. 2013;(4):ED000058. https://doi.org/10.1002/14651858.ed000058
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276(8):637-9. https://doi.org/10.1001/jama.276.8.637
Bandello F, Brancato R, Trabucchi G, Lattanzio R, Malegori A. Diode versus argon-green laser panretinal photocoagulation in proliferative diabetic retinopathy: a randomized study in 44 eyes with a long follow-up time. Graefes Arch Clin Exp Ophthalmol. 1993;231(9):491-4. https://doi.org/10.1007/bf00921112
Day SJ, Altman DG. Statistics notes: blinding in clinical trials and other studies. BMJ. 2000;321(7259):504. https://doi.org/10.1136/bmj.321.7259.504
Pildal J, Hróbjartsson A, Jørgensen KJ, Hilden J, Altman DG, Gøtzsche PC. Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials. Int J Epidemiol. 2007;36(4):847-57. https://doi.org/10.1093/ije/dym087
Newell DJ. Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol. 1992;21(5):837-41. https://doi.org/10.1093/ije/21.5.837
Kang H. The prevention and handling of the missing data. Korean J Anesthesiol. 2013;64(5):402-6. https://dx.doi.org/10.4097%2Fkjae.2013.64.5.402
Chan A, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials: Comparison of Protocols to Published Articles. JAMA. 2004;291(20):2457–65. https://doi.org/10.1001/jama.291.20.2457
Chan AW, Krleza-Jeri? K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ. 2004;171(7):735-40. https://doi.org/10.1503/cmaj.1041086
Drucker AM, Fleming P, Chan AW. Research Techniques Made Simple: Assessing Risk of Bias in Systematic Reviews. J Invest Dermatol. 2016;136(11):e109-14. https://doi.org/10.1016/j.jid.2016.08.021
Mozetic V, Barros VM, Denadai L, Cruz MFS, Cruz NFS, Moraes NSB. Bias and unclear outcomes in clinical trials of diabetic retinopathy: a cross-sectional analysis of literature. Evidence. 2022;3:e3415. https://doi.org/10.17267/2675-021Xevidence.2021.e3415
The Food and Drug Administration (US). Modernization of Food and Drug Administration Act 1997 (FDAMA) in Congress Approves the Law (FDAMA) [Internet]. Available from: https://www.govinfo.gov/content/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf#page=16
Jørgensen L, Paludan-Müller AS, Laursen DR, Savovi? J, Boutron I, Sterne JA, et al. Evaluation of the Cochrane tool for assessing risk of bias in randomized clinical trials: overview of published comments and analysis of user practice in Cochrane and non-Cochrane reviews. Syst Rev. 2016;5:80. https://doi.org/10.1186/s13643-016-0259-8
Liu Y, Yang S, Dai J, Xu Y, Zhang R, Jiang H, et al. Risk of Bias Tool in Systematic Reviews/Meta-Analyses of Acupuncture in Chinese Journals. PLoS One. 2011;6(12):e28130. https://doi.org/10.1371/journal.pone.0028130
Savovi? J, Turner RM, Mawdsley D, Jones HE, Beynon R, Higgins JPT, et al. Association Between Risk-of-Bias Assessments and Results of Randomized Trials in Cochrane Reviews: The ROBES Meta-Epidemiologic Study. Am J Epidemiol. 2018;187(5):1113-22. https://doi.org/10.1093/aje/kwx344
Viswanathan M, Ansari MT, Berkman ND, Chang S, Hartling L, McPheeters M, et al. Assessing the Risk of Bias of Individual Studies in Systematic Reviews of Health Care Interventions [Internet]. In: Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK91433/
Mozetic V, Leonel L, Pacheco RL, Latorraca COC, Guimarães T, Logullo P, et al. Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist. Trials. 2019;20:729. https://doi.org/10.1186/s13063-019-3868-4
Mozetic V, Barros VM, Denadai L, Cruz MFS, Cruz NFS, Moraes NSB. A warning to readers about the term metanalysis in non-systematic reviews about diabetic retinopathy: documental study. Evidence.2021;2(2):125–30. https://doi.org/10.17267/2675-021Xevidence.v2i2.3416
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Copyright (c) 2022 Lucas Denadai
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