The Cochrane Collaboration's tool for assessing risk of bias in randomised trials

Julian P T Higgins, Douglas G Altman, Peter C Gøtzsche, Peter Jüni, David Moher, Andrew D Oxman, Jelena Savovic, Kenneth F Schulz, Laura Weeks, Jonathan A C Sterne, Cochrane Bias Methods Group, Cochrane Statistical Methods Group, Julian P T Higgins, Douglas G Altman, Peter C Gøtzsche, Peter Jüni, David Moher, Andrew D Oxman, Jelena Savovic, Kenneth F Schulz, Laura Weeks, Jonathan A C Sterne, Cochrane Bias Methods Group, Cochrane Statistical Methods Group

Abstract

Flaws in the design, conduct, analysis, and reporting of randomised trials can cause the effect of an intervention to be underestimated or overestimated. The Cochrane Collaboration’s tool for assessing risk of bias aims to make the process clearer and more accurate

Conflict of interest statement

Competing interests: All authors have completed the ICJME unified disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare support from the Cochrane Collaboration for the development and evaluation of the tool described; they have no financial relationships with any organisations that might have an interest in the submitted work in the previous three years and no other relationships or activities that could appear to have influenced the submitted work.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4788283/bin/higj860676.f1_default.jpg
Fig 1 Example presentation of risk of bias assessments for studies in a Cochrane review of therapeutic monitoring of antiretroviral drugs in people with HIV

References

    1. Kleijnen J, Gøtzsche P, Kunz RH, Oxman AD, Chalmers I. So what’s so special about randomisation? In: Maynard A, Chalmers I, eds. Non-random reflections on health services research: on the 25th anniversary of Archie Cochrane’s Effectiveness and Efficiency. BMJ Books, 1997:93-106.
    1. Wood L, Egger M, Gluud LL, Schulz K, Jüni P, Altman DG, 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.
    1. Egger M, Davey Smith G, Altman DG, eds. Systematic reviews in health care: meta-analysis in context. BMJ Books, 2001.
    1. Moher D, Jadad AR, Nichol G, Penman M, Tugwell P, Walsh S. Assessing the quality of randomized controlled trials—an annotated bibliography of scales and checklists. Controlled Clin Trials 1995;12:62-73.
    1. Jüni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ 2001;323:42-6.
    1. West S, King V, Carey TS, Lohr KN, McKoy N, Sutton SF, et al. Systems to rate the strength of scientific evidence. Evidence report/technology assessment no 47. AHRQ publication No 02-E016. Agency for Healthcare Research and Quality, 2002.
    1. Crowe M, Sheppard L. A review of critical appraisal tools show they lack rigor: alternative tool structure is proposed. J Clin Epidemiol 2011;64:79-89.
    1. Lundh A, Gøtzsche PC. Recommendations by Cochrane Review Groups for assessment of the risk of bias in studies. BMC Med Res Methodol 2008;8:22.
    1. Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions. Wiley, 2008.
    1. Greenland S, O’Rourke K. On the bias produced by quality scores in meta-analysis, and a hierarchical view of proposed solutions. Biostatistics 2001;2:463-71.
    1. Jüni P, Witschi A, Bloch R, Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA 1999;282:1054-60.
    1. Gluud LL. Bias in clinical intervention research. Am J Epidemiol 2006;163:493-501.
    1. Higgins JPT, Altman DG. Assessing risk of bias in included studies. In: Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions. Wiley, 2008:187-241.
    1. Kredo T, Van der Walt J-S, Siegfried N, Cohen K. Therapeutic drug monitoring of antiretrovirals for people with HIV. Cochrane Database Syst Rev 2009;3:CD007268.
    1. Higgins JPT, Thompson SG. Controlling the risk of spurious findings from meta-regression. Stat Med 2004;23:1663-82.
    1. Guyatt GH, Oxman AD, Vist GE, Zunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6.
    1. Schünemann HJ, Oxman AD, Higgins JPT, Vist GE, Glasziou P, Guyatt GH, et al. Presenting results and “Summary of findings” tables. In: Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions. Wiley, 2008:335-8.
    1. Schünemann HJ, Oxman AD, Vist GE, Higgins JPT, Deeks JJ, Glasziou P, et al. Interpreting results and drawing conclusions. In: Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions. Wiley, 2008:359-87.
    1. Leizorovicz A, Haugh MC, Chapuis FR, Samama MM, Boissel JP. Low molecular weight heparin in prevention of perioperative thrombosis. BMJ 1992;305:913-20.
    1. Nurmohamed MT, Rosendaal FR, Buller HR, Dekker E, Hommes DW, Vandenbroucke JP, et al. Low-molecular-weight heparin versus standard heparin in general and orthopaedic surgery: a meta-analysis. Lancet 1992;340:152-6.
    1. Lelorier J, Benhaddad A, Lapierre J, Derderian F. Discrepancies between meta-analyses and subsequent large randomized, controlled trials. N Engl J Med 1997;337:536-42.
    1. Hartling L, Ospina M, Liang Y, Dryden DM, Hooton N, Krebs SJ, et al. Risk of bias versus quality assessment of randomised controlled trials: cross sectional study. BMJ 2009;339:b4012.

Source: PubMed

3
Prenumerera