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Cited by 150

The DOI matches its Crossref record; 6 of the 6 references it cites were found in a registry or an index.

Reliability of the revised Cochrane risk-of-bias tool for randomised trials (RoB2) improved with the use of implementation instruction

Minozzi, Silvia, Dwan, Kerry, Borrelli, Francesca, Filippini, Graziella·2022·Journal of Clinical Epidemiology
DOI 10.1016/j.jclinepi.2021.09.021
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Abstract

Objective to assess the inter-rater reliability (IRR) of the revised Cochrane risk-of-bias tool for randomised trials (RoB2). Methods Four raters independently applied RoB2 on critical and important outcomes of individually randomized parallel-group trials (RCTs) included in the Cochrane Review "Cannabis and cannabinoids for people with multiple sclerosis." We calculated Fleiss' Kappa for multiple raters and time to complete the tool; we performed a calibration exercise on five studies, then we developed an implementation document (ID) specific for the condition, and the intervention addressed by the review with instructions on how to answer the signalling questions of RoB2 tool. We measured IRR before and after the ID adoption RESULTS: Eighty results related to seven outcomes from 16 RCTs were assessed. During calibration exercise we reached no agreement for overall judgment (IRR -0.15); IRR for individual domains ranged from no agreement to fair. Mean time to apply the tool was 168.5 minutes per study. Time to complete the calibration exercise and develop the ID was about 40 hours. After the ID adoption ID, overall agreement increased to slightly (IRR 0.11) for the first five studies and moderate (IRR 0.42) for the remaining 11. IRR for individual domains ranged from no agreement to almost perfect. Mean time to apply the tool decreased to 41 minutes. Conclusion RoB2 tool is comprehensive but complex even for high experienced raters. The development of an ID specific for the…

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Research works printed but not linked: 8

  1. Higgins, 2011, Cochrane bias methods group, cochrane statistical methods group. The cochrane collaboration’s tool for assessing risk of bias in randomised trials, BMJ, 343, d5928, 10.1136/bmj.d5928 · DOI · Paper page
  2. Puljak, 2020, Cochrane risk of bias tool was used inadequately in the majority of non-Cochrane systematic reviews, J Clin Epidemiol, 123, 114, 10.1016/j.jclinepi.2020.03.019 · DOI
  3. Filippini, 2019, Cannabis and cannabinoids for people with multiple sclerosis, Cochrane Database Syst Rev
  4. Landis, 1977, The measurement of observer agreement for categorical data, Biometrics, 33, 159, 10.2307/2529310 · DOI · Paper page
  5. Wright, 2012, Assessment of blinding to treatment allocation in studies of a cannabis-based medicine (Sativex®) in people with multiple sclerosis: a new approach, Trials, 13, 189, 10.1186/1745-6215-13-189 · DOI
  6. Naci, 2019, Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European medicines agency, 2014-16: cross sectional analysis, BMJ, 366, l5221, 10.1136/bmj.l5221 · DOI
  7. de Almeida, 2019, Allocation concealment and intention-to-treat analysis do not influence the treatment effects of physical therapy interventions in low back pain trials: a meta-epidemiologic study, Arch Phys Med Rehabil, 100, 1359, 10.1016/j.apmr.2018.12.036 · DOI
  8. Armijo-Olivo, 2015, What is the influence of randomisation sequence generation and allocation concealment on treatment effects of physical therapy trials? A meta-epidemiological study, BMJ Open, 5, 10.1136/bmjopen-2015-008562 · DOI

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Metadata

Authors
Minozzi, S., Dwan, K., Borrelli, F., & Filippini, G.
ORCID
Venue
Journal of Clinical Epidemiology
Publisher
Elsevier BV
Published
2022-01
Volume
141
Pages
99-105
ISSN
0895-4356
DOI
10.1016/j.jclinepi.2021.09.021
Cited by
150
References
6
Language
en
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