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.
Original language | English |
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Article number | i4919 |
Number of pages | 7 |
Journal | BMJ |
Volume | 355 |
DOIs | |
Publication status | Published - 12 Oct 2016 |
Bibliographical note
Development of ROBINS-I was funded by a Methods Innovation Fund grant from Cochrane and Medical Research Council grant MR/M025209/1. Sterne and Higgins are members of the Medical Research Council Integrative Epidemiology Unit at the University of Bristol which is supported by the Medical Research Council and the University of Bristol (grant MC_UU_12013/9). This research waspartly funded by NIH grant P01 CA134294. Sterne was supported by National Institute for Health Research Senior Investigator award NF-SI-0611-10168. Savović and Whiting were supported by National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West). Reeves was supported by the National Institute for Health Research 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, the NIHR or the Department of Health.
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Craig Ramsay
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Director of Health Services Research Unit
- Institute of Applied Health Sciences
Person: Academic