Journal article
ROBINS-I: A tool for assessing risk of bias in non-randomised studies of interventions
JA Sterne, MA Hernán, BC Reeves, J Savović, ND Berkman, M Viswanathan, D Henry, DG Altman, MT Ansari, I Boutron, JR Carpenter, AW Chan, R Churchill, JJ Deeks, A Hróbjartsson, J Kirkham, P Jüni, YK Loke, TD Pigott, CR Ramsay Show all
BMJ Online | BMJ PUBLISHING GROUP | Published : 2016
DOI: 10.1136/bmj.i4919
Open access
Abstract
Non-randomised studies of the effects of interventions are critical to many areas of healthcare evaluation, but their results may be biased. It is therefore important to understand and appraise their strengths and weaknesses. We developed ROBINS-I ("Risk Of Bias In Non-randomised Studies-of Interventions"), a new tool for evaluating risk of bias in estimates of the comparative effectiveness (harm or benefit) of interventions from studies that did not use randomisation to allocate units (individuals or clusters of individuals) to comparison groups. The tool will be particularly useful to those undertaking systematic reviews that include non-randomised studies.
Grants
Awarded by Medical Research Council
Funding Acknowledgements
Development of ROBINS-I was funded by a Methods Innovation Fund grant from Cochrane and Medical Research Council (MRC) grant MR/M025209/1. Sterne and Higgins are members of the MRC Integrative Epidemiology Unit at the University of Bristol, which is supported by the MRC and the University of Bristol (grant MC_UU_12013/9). This research was partly funded by NIH grant P01 CA134294. Sterne was supported by National Institute for Health Research (NIHR) Senior Investigator award NF SI 0611 10168. Savovic and Whiting were supported by NIHR Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West). Reeves was supported by the NIHR Bristol Biomedical Research Unit in Cardiovascular Disease. None of the funders had a role in the development of the ROBINS-I tool, although employees of Cochrane contributed to some of the meetings and workshops. The views expressed are those of the authors and not necessarily those of Cochrane, the NHS, NIHR, or Department of Health.