{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T15:30:26Z","timestamp":1776958226379,"version":"3.51.4"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,7,1]]},"DOI":"10.7759\/cureus.63581","type":"journal-article","created":{"date-parts":[[2024,7,1]],"date-time":"2024-07-01T08:55:45Z","timestamp":1719824145000},"source":"Crossref","is-referenced-by-count":8,"title":["Selection Bias Risk in Randomized Controlled Trials Rated as Low Bias Using Risk of Bias, Version 2 (RoB2) Tool"],"prefix":"10.7759","author":[{"given":"Steffen","family":"Mickenautsch","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veerasamy","family":"Yengopal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","reference":[{"key":"ref1","article-title":"So what\u2019s so special about randomisation?","author":"Kleijnen J","year":"1997","unstructured":"Kleijnen J, G\u00f8tzsche P, Kunz RH, et al.. So what\u2019s so special about randomisation?. Non-random Reflections on Health Services Research: On the 25th Anniversary of Archie Cochrane\u2019s Effectiveness and Efficiency. Maynard A, Chalmers I (ed): BMJ Books, London, UK; 1997. 93-106."},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39465.451748.AD","article-title":"Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study","volume":"336","author":"Wood L","year":"2008","unstructured":"Wood L, Egger M, Gluud LL, et al.. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008, 336:601-5. 10.1136\/bmj.39465.451748.AD","journal-title":"BMJ"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d5928","article-title":"The cochrane collaboration's tool for assessing risk of bias in randomised trials","volume":"343","author":"Higgins JP","year":"2011","unstructured":"Higgins JP, Altman DG, G\u00f8tzsche PC, et al.. The cochrane collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011, 343:d5928. 10.1136\/bmj.d5928","journal-title":"BMJ"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l4898","article-title":"RoB 2: a revised tool for assessing risk of bias in randomised trials","volume":"366","author":"Sterne JA","year":"2019","unstructured":"Sterne JA, Savovi\u0107 J, Page MJ, et al.. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019, 366:l4898. 10.1136\/bmj.l4898","journal-title":"BMJ"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2020.06.015","article-title":"The revised cochrane risk of bias tool for randomized trials (RoB 2) showed low interrater reliability and challenges in its application","volume":"126","author":"Minozzi S","year":"2020","unstructured":"Minozzi S, Cinquini M, Gianola S, Gonzalez-Lorenzo M, Banzi R. The revised cochrane risk of bias tool for randomized trials (RoB 2) showed low interrater reliability and challenges in its application. J Clin Epidemiol. 2020, 126:37-44. 10.1016\/j.jclinepi.2020.06.015","journal-title":"J Clin Epidemiol"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.09.021","article-title":"Reliability of the revised cochrane risk-of-bias tool for randomised trials (RoB2) improved with the use of implementation instruction","volume":"141","author":"Minozzi S","year":"2022","unstructured":"Minozzi S, Dwan K, Borrelli F, Filippini G. Reliability of the revised cochrane risk-of-bias tool for randomised trials (RoB2) improved with the use of implementation instruction. J Clin Epidemiol. 2022, 141:99-105. 10.1016\/j.jclinepi.2021.09.021","journal-title":"J Clin Epidemiol"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0159267","article-title":"Empirical evidence of study design biases in randomized trials: systematic review of meta-epidemiological studies","volume":"11","author":"Page MJ","year":"2016","unstructured":"Page MJ, Higgins JP, Clayton G, Sterne JA, Hr\u00f3bjartsson A, Savovi\u0107 J. Empirical evidence of study design biases in randomized trials: systematic review of meta-epidemiological studies. PLoS One. 2016, 11:e0159267. 10.1371\/journal.pone.0159267","journal-title":"PLoS One"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2017.10.001","article-title":"A simple technique investigating baseline heterogeneity helped to eliminate potential bias in meta-analyses","volume":"95","author":"Hicks A","year":"2018","unstructured":"Hicks A, Fairhurst C, Torgerson DJ. A simple technique investigating baseline heterogeneity helped to eliminate potential bias in meta-analyses. J Clin Epidemiol. 2018, 95:55-62. 10.1016\/j.jclinepi.2017.10.001","journal-title":"J Clin Epidemiol"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2014.04.007","article-title":"A methodological review of recent meta-analyses has found significant heterogeneity in age between randomized groups","volume":"67","author":"Clark L","year":"2014","unstructured":"Clark L, Fairhurst C, Hewitt CE, et al.. A methodological review of recent meta-analyses has found significant heterogeneity in age between randomized groups. J Clin Epidemiol. 2014, 67:1016-24. 10.1016\/j.jclinepi.2014.04.007","journal-title":"J Clin Epidemiol"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.58961","article-title":"Trial number and sample size do not affect the accuracy of the I2-point estimate for testing selection bias risk in meta-analyses","volume":"16","author":"Mickenautsch S","year":"2024","unstructured":"Mickenautsch S, Yengopal V. Trial number and sample size do not affect the accuracy of the I2-point estimate for testing selection bias risk in meta-analyses. Cureus. 2024, 16:e58961. 10.7759\/cureus.58961","journal-title":"Cureus"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.60346","article-title":"A test method for identifying selection bias risk in prospective controlled clinical therapy trials using the I2 point estimate","volume":"16","author":"Mickenautsch S","year":"2024","unstructured":"Mickenautsch S, Yengopal V. A test method for identifying selection bias risk in prospective controlled clinical therapy trials using the I2 point estimate. Cureus. 2024, 16:e60346. 10.7759\/cureus.60346","journal-title":"Cureus"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.21203\/rs.3.rs-3899395\/v1","article-title":"Selection bias risk in randomised control trials rated as of \u201clow bias\u201d risk according to Cochrane\u2019s Risk of Bias 2 tool (protocol) [PREPRINT]","author":"Mickenautsch S","year":"2024","unstructured":"Mickenautsch S, Yengopal V. Selection bias risk in randomised control trials rated as of \u201clow bias\u201d risk according to Cochrane\u2019s Risk of Bias 2 tool (protocol) [PREPRINT]. Res Sq. 2024, 10.21203\/rs.3.rs-3899395\/v1","journal-title":"Res Sq"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1000097","article-title":"Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement","volume":"6","author":"Moher D","year":"2009","unstructured":"Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009, 6:e1000097. 10.1371\/journal.pmed.1000097","journal-title":"PLoS Med"},{"key":"ref14","unstructured":"Sealed envelope. (2023). Accessed. December 2, 2023: https:\/\/www.sealedenvelope.com\/simple-randomiser\/v1\/lists."},{"key":"ref15","unstructured":"Random number generator. (2023). Accessed. December 2, 2023: https:\/\/www.calculator.net\/random-number-generator.html."},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-5-13","article-title":"Estimating the mean and variance from the median, range, and the size of a sample","volume":"5","author":"Hozo SP","year":"2005","unstructured":"Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol. 2005, 5:13. 10.1186\/1471-2288-5-13","journal-title":"BMC Med Res Methodol"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-14-135","article-title":"Estimating the sample mean and standard deviation from the sample size, median, range and\/or interquartile range","volume":"14","author":"Wan X","year":"2014","unstructured":"Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and\/or interquartile range. BMC Med Res Methodol. 2014, 14:135. 10.1186\/1471-2288-14-135","journal-title":"BMC Med Res Methodol"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1002\/9780470693926","article-title":"Systematic reviews of evaluations of diagnostic and screening tests","author":"Deeks JJ","year":"2001","unstructured":"Deeks JJ. Systematic reviews of evaluations of diagnostic and screening tests. Systematic Reviews in Health Care: Meta\u2010Analysis in Context. Egger M, Smith GD, Altman DG (ed): BMJ books, London, UK; 2001. 251-2. 10.1002\/9780470693926"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.1001\/jama.271.9.703","article-title":"Users' guides to the medical literature. III. How to use an article about a diagnostic test. B. What are the results and will they help me in caring for my patients? The Evidence-Based Medicine Working Group","volume":"271","author":"Jaeschke R","year":"1994","unstructured":"Jaeschke R, Guyatt GH, Sackett DL. Users' guides to the medical literature. III. How to use an article about a diagnostic test. B. What are the results and will they help me in caring for my patients? The Evidence-Based Medicine Working Group. JAMA. 1994, 271:703-7. 10.1001\/jama.271.9.703","journal-title":"JAMA"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.1002\/jrsm.1392","article-title":"Ten questions to consider when interpreting results of a meta-epidemiological study-the MetaBLIND study as a case","volume":"11","author":"Moustgaard H","year":"2020","unstructured":"Moustgaard H, Jones HE, Savovi\u0107 J, Clayton GL, Sterne JA, Higgins JP, Hr\u00f3bjartsson A. Ten questions to consider when interpreting results of a meta-epidemiological study-the MetaBLIND study as a case. Res Synth Methods. 2020, 11:260-74. 10.1002\/jrsm.1392","journal-title":"Res Synth Methods"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0279645","article-title":"Extension of the composite quality Score (CQS) as an appraisal tool for prospective, controlled clinical therapy trials-a systematic review of meta-epidemiological evidence","volume":"17","author":"Mickenautsch S","year":"2022","unstructured":"Mickenautsch S, Rupf S, Mileti\u0107 I, Yengopal V. Extension of the composite quality Score (CQS) as an appraisal tool for prospective, controlled clinical therapy trials-a systematic review of meta-epidemiological evidence. PLoS One. 2022, 17:e0279645. 10.1371\/journal.pone.0279645","journal-title":"PLoS One"},{"key":"ref22","unstructured":"Number of clinical trial registrations by location, disease, phase of development, age and sex of trial participants (1999-2022). (2024). Accessed. May 07, 2024: https:\/\/www.who.int\/observatories\/global-observatory-on-health-research-and-development\/monitoring\/number-of-trial-re...."},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.21203\/rs.3.rs-3281346\/v1","article-title":"The limits of inductive reasoning for clinical evidence appraisal - a simulation study [PREPRINT]","author":"Mickenautsch S","year":"2023","unstructured":"Mickenautsch S, Yengopal V. The limits of inductive reasoning for clinical evidence appraisal - a simulation study [PREPRINT]. Res Sq. 2023, 10.21203\/rs.3.rs-3281346\/v1","journal-title":"Res Sq"},{"key":"ref24","doi-asserted-by":"publisher","DOI":"10.1080\/19466315.2023.2239521","article-title":"Regulatory guidance on randomization and the use of randomization tests in clinical trials: a systematic review [IN PRESS]","author":"Carter K","year":"2023","unstructured":"Carter K, Scheffold AL, Renteria J, et al.. Regulatory guidance on randomization and the use of randomization tests in clinical trials: a systematic review [IN PRESS]. Stat Biopharma Res. 2023, 1-13. 10.1080\/19466315.2023.2239521","journal-title":"Stat Biopharma Res"},{"key":"ref25","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djz126","article-title":"A review of perspectives on the use of randomization in phase II oncology trials","volume":"111","author":"Grayling MJ","year":"2019","unstructured":"Grayling MJ, Dimairo M, Mander AP, Jaki TF. A review of perspectives on the use of randomization in phase II oncology trials. J Natl Cancer Inst. 2019, 111:1255-62. 10.1093\/jnci\/djz126","journal-title":"J Natl Cancer Inst"},{"key":"ref26","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-8-79","article-title":"Undue reliance on I(2) in assessing heterogeneity may mislead","volume":"8","author":"R\u00fccker G","year":"2008","unstructured":"R\u00fccker G, Schwarzer G, Carpenter JR, Schumacher M. Undue reliance on I(2) in assessing heterogeneity may mislead. BMC Med Res Methodol. 2008, 8:79. 10.1186\/1471-2288-8-79","journal-title":"BMC Med Res Methodol"},{"key":"ref27","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-015-0024-z","article-title":"The heterogeneity statistic I(2) can be biased in small meta-analyses","volume":"15","author":"von Hippel PT","year":"2015","unstructured":"von Hippel PT. The heterogeneity statistic I(2) can be biased in small meta-analyses. BMC Med Res Methodol. 2015, 15:35. 10.1186\/s12874-015-0024-z","journal-title":"BMC Med Res Methodol"}],"container-title":["Cureus"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cureus.com\/articles\/267579-selection-bias-risk-in-randomized-controlled-trials-rated-as-low-bias-using-risk-of-bias-version-2-rob2-tool","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,1]],"date-time":"2024-07-01T08:55:51Z","timestamp":1719824151000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cureus.com\/articles\/267579-selection-bias-risk-in-randomized-controlled-trials-rated-as-low-bias-using-risk-of-bias-version-2-rob2-tool"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,1]]},"references-count":27,"URL":"https:\/\/doi.org\/10.7759\/cureus.63581","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-3899395\/v1","asserted-by":"object"}]},"ISSN":["2168-8184"],"issn-type":[{"value":"2168-8184","type":"print"}],"subject":[],"published":{"date-parts":[[2024,7,1]]}}}