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A unified framework for bias assessment in clinical research

Stone, Jennifer C.1,2; Glass, Kathryn3; Clark, Justin4; Munn, Zachary5; Tugwell, Peter6; Doi, Suhail A.R.7

International Journal of Evidence-Based Healthcare: June 2019 - Volume 17 - Issue 2 - p 106–120
doi: 10.1097/XEB.0000000000000165
METHODOLOGY ARTICLE
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ABSTRACT Methodological flaws, limitations, and inadequate practices in research are well known and pose threats to the internal validity of any research study. However, there are ways of safeguarding research conduct to reduce the chance of research producing distorted results. Numerous tools now exist to assess the incorporation of such safeguards into primary research studies (also known as quality and/or risk-of-bias assessment). These tools typically include a variety of items that are then checked against those implemented in the study. Despite a lot of research in this area, no comprehensive generic classification of safeguards across study designs exist, although attempts have been made to clarify aspects of this. We review the developments in this area as well as use preliminary data from 100 methodological studies to illustrate our proposed approach. We conclude by proposing a new framework for identifying research studies at risk of being biased and the information in this article will promote a unification of the diverse approaches to facilitating bias assessment in clinical research.

1Department of Health Services Research and Policy, Research School of Population Health, Australian National University, Canberra, Australian Capital Territory, Australia

2Department for Health Evidence, SYRCLE, Radboud University Medical Center, Nijmegen, The Netherlands

3National Centre for Epidemiology and Population Health, Research School of Population Health, Australian National University, Canberra, Australian Capital Territory

4Centre for Research in Evidence Based Practice, Bond University, Queensland

5The Joanna Briggs Institute, The University of Adelaide, Adelaide, South Australia, Australia

6Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada

7Department of Population Medicine, College of Medicine, Qatar University, Doha, Qatar

Correspondence: Suhail A. Doi, PhD, FRCP(Edin), Department of Population Medicine, College of Medicine, Qatar University, Doha, Qatar. E-mail: sardoi@gmx.net

International Journal of Evidence-Based Healthcare © 2019 The Joanna Briggs Institute
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