A few additional protocols (1.9%) planned to use Cochrane RoB 2 Tool, which was first introduced in 2016 as an update to the original Cochrane RoB Tool [In protocols that intended to include both RCT and NRS, the choice of tools was more heterogeneous, consistent in finding with current opinion that there is no consensus on the preferred tools for evaluating bias in NRS [When systematic reviews that intended to include NRS planned to use multiple tools to assess risk of bias, the Newcastle-Ottawa Scale was the most commonly listed RoB tool to assess NRS (39%), followed by ROBINS-I (33%). We excluded Cochrane review protocols because they were assumed to use Cochrane methodology and RoB tools. Cochrane handbook for systematic reviews of interventions version 5.1.0 [updated March 2011]: The Cochrane Collaboration; 2011. Part of Findings from the focus groups were then fed into the design of questionnaires for use in three online surveys of review authors who had used the tool, review authors who had not used the tool (to explore why not), and editorial teams within the collaboration. Preliminary evidence suggests that incomplete outcome data and selective reporting are the most difficult items to assess; kappa measures of agreement of 0.32 (fair) and 0.13 (slight) respectively have been reported for these.We hope that widespread adoption and implementation of the risk of bias tool, both within and outside the Cochrane Collaboration, will facilitate improved appraisal of evidence by healthcare decision makers and patients and ultimately lead to better healthcare. Cochrane Methods. Conversely, results of a trial that used the best possible methods may still be at risk of bias. 2011;64(4):401–6.Pace R, Pluye P, Bartlett G, Macaulay AC, Salsberg J, Jagosh J, 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. 2017;358:j4008.Public Health Ontario. The number of records retrieved for each tool per year was recorded. Ann Intern Med. The views expressed in this article are those of the authors and not necessarily those of The Cochrane Collaboration or its registered entities, committees or working groups.. JPTH was also funded by MRC grant number U.1052.00.011. Quality assessment tools for observational studies: lack of consensus. In doing this, review authors must decide which domains are most important in the context of the review, ideally when writing their protocol. 2018;34(12):2125–30.Higgins JPT, Altman DG, Sterne JAC, on behalf of the Cochrane Statistical Methods Group and the Cochrane Bias Methods Group. Over half of the protocols that planned to include NRS listed only a single RoB tool, most frequently the Cochrane RoB Tool. 2003;73(9):712–6.Centre for Evidence-Based Medicine (CEBM). Objectives: To introduce PROBAST, a tool for assessing the risk of bias and applicability of prediction modelling studies in a SR. Methods: A Delphi process, involving 40 prediction research experts was used until agreement on the content of the final tool was reached. 2017;14(1):49.Waddington H, Aloe AM, Becker BJ, Djimeu EW, Hombrados JG, Tugwell P, et al.
Given the ongoing development of new RoB tools, certain tools may have fallen out of favor or gained currency over time.In the present study, we conducted a cross-sectional analysis of systematic review protocols on health interventions registered in PROSPERO to identify which tools were the most commonly cited in 2018 to evaluate the risk of bias of RCT and NRS in systematic reviews. Using keywords and name variants for each tool, we searched PROSPERO records by year since the inception of the database (2011) to December 7, 2018, restricting the keyword search to the “Risk of bias (quality) assessment” field. Of 187 authors surveyed, 88% took longer than 10 minutes to complete the new tool, 44% longer than 20 minutes, and 7% longer than an hour, but 83% considered the time taken acceptable. A year-by-year search of PROSPERO records was performed on these 12 RoB tools. The two preferable analytical strategies are to restrict the primary meta-analysis to studies at low risk of bias or to present meta-analyses stratified according to risk of bias. J Clin Epidemiol. Issues relating to study design and risk of bias when including non-randomized studies in systematic reviews on the effects of interventions. The full search strategy is provided in Additional file 3. Selection of 2018 Sample of PROSPERO Protocols. There was also consensus that assessment of blinding should be separated into blinding of participants and health professionals (performance bias) and blinding of outcome assessment (detection bias) and that the phrasing of the judgments about risk should be changed to low, high, and unclear risk. Search Cochrane handbook for systematic reviews of interventions version 5.1.0 [updated March 2011]: The Cochrane Collaboration; 2011.
Detailed criteria for making judgments about the risk of bias from each of the items in the tool are available in the Some of the items in the tool, such as methods for randomisation, require only a single assessment for each trial included in the review. 2019;25(1):44–52.Seehra J, Pandis N, Koletsi D, Fleming PS. It would be easier to assess whether a drop-out rate exceeds 20% than whether a drop-out rate of 21% introduces an important risk of bias, but there is no guarantee that results from a study with a drop-out rate lower than 20% are at low risk of bias. Before the meeting, JPTH and DGA compiled an extensive list of potential sources of bias in clinical trials. Int J Evid Based Healthc.
2014;12(12):1495–9.NICE. Real world evidence.
2003;7(27):iii–x, 1–173.Hartling L, Milne A, Hamm MP, Vandermeer B, Ansari M, Tsertsvadze A, et al.
Changes to the Cochrane ‘Risk of bias’ tool for RevMan 5.1 March 2011 After an extensive evaluation of the ‘Risk of bias’ tool, modifications and improvements have been made and an updated version of the tool has been implemented in RevMan 5.1.