4.7 Article

ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions

Journal

BMJ-BRITISH MEDICAL JOURNAL
Volume 355, Issue -, Pages -

Publisher

BMJ PUBLISHING GROUP
DOI: 10.1136/bmj.i4919

Keywords

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Funding

  1. Methods Innovation Fund grant from Cochrane and Medical Research Council (MRC) [MR/M025209/1]
  2. MRC
  3. University of Bristol [MC_UU_12013/9]
  4. NIH [P01 CA134294]
  5. National Institute for Health Research (NIHR) [NF SI 0611 10168]
  6. NIHR Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West)
  7. NIHR Bristol Biomedical Research Unit in Cardiovascular Disease
  8. Cancer Research UK [16895] Funding Source: researchfish
  9. Chief Scientist Office [HSRU1] Funding Source: researchfish
  10. Medical Research Council [MC_UU_12023/24, MC_UU_12023/21, MR/M025209/1, MC_UU_12013/9] Funding Source: researchfish
  11. National Institute for Health Research [NF-SI-0611-10168] Funding Source: researchfish
  12. MRC [MC_UU_12013/9, MR/J004855/1, MC_UU_12023/24, MC_UU_12023/21, MR/M025209/1] Funding Source: UKRI

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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.

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