Assessing the risk of bias in studies evaluating the effects of interventions and of exposures (in- person workshop)
Professor Julian Higgins, University of Bristol, will be leading this two-day (in-person) workshop, providing a unique opportunity to learn from the lead developer of the risk of bias tools. The course is designed for those undertaking systematic reviews, synthesizing evidence for guidelines, or generally interested in how to appraise studies. For registration information, please see here
Day 1 of the course will introduce participants to tools for assessing risk of bias in studies with a focus on randomized trials using the RoB 2 tool. Day 2 of the course will cover assessing the risk of bias in non-randomized/observational studies, covering the ROBINS-I and ROBINS-E tools. Familiarity with domain-based risk-of-bias assessment tools and the issues addressed by RoB 2 tool will be assumed for Day 2. Therefore, participants who are not familiar with the RoB 2 tool will need to attend both days. Details of what will be covered each day are below.
The workshop involves a mix of presentations, interactive examples and hands-on exercises.
Electronic copies of the slides will be provided on the day of the workshop.
Outline
Day 1:
- Introduction to risk-of-bias assessment
- Overview of the RoB 2 tool
- Bias arising from the randomization process
- Intention-to-treat versus per-protocol effects and bias due deviations from intended interventions
- Bias due to missing data
- Bias arising from measurement of the outcome
- Bias in selection of the reported result
Day 2:
- Introduction to the ROBINS tools
- Preliminary considerations, including specification of the causal effect of interest
- Bias due to confounding
- Bias in classification of intervention or measurement of exposure
- Bias in selection of participants into the study
- Bias due to deviations from intended intervention or post-exposure interventions
- Bias due to missing data, measurement of the outcome and selection of the reported result
Course facilitators
Julian Higgins, University of Bristol, UK: Julian is Professor of Evidence Synthesis with a long-standing interest in methodology of systematic reviews and meta-analysis. He is author of over 350 publications, collectively cited more than 350,000 times. His contributions include: a Bayesian approach to network meta-analysis; the I-squared statistic to quantify inconsistency across studies in a meta-analysis; simple prediction intervals for random-effects meta-analysis; a general framework for individual participant data meta-analysis; and risk-of-bias assessment tools for clinical trials and other study designs. He is a past President of the Society for Research Synthesis Methodology and has co-edited the Cochrane Handbook for Systematic Reviews of Interventions since 2003. He is also co-author of the Wiley textbook Introduction to Meta-analysis and co-editor of the 3rd edition of Wiley textbook Systematic Reviews in Health Research: Meta-analysis in Context. Read more about Julian’s research interests here.
Matthew Page, Monash University: Matthew is a Senior Research Fellow and Deputy Head of the Methods in Evidence Synthesis Unit. His research aims to improve the quality of systematic reviews of health and medical research. He has led many studies investigating the transparency, reproducibility and risk of bias in systematic reviews and the studies they include and has developed several methods to address these issues. For example, he co-led the development of the PRISMA 2020 statement, a highly cited reporting guideline for systematic reviews, was a member of the core group who developed the RoB 2 tool for assessing risk of bias in randomized trials, and led the development of the ROB-ME tool for assessing risk of bias due to missing evidence in meta-analyses. He is a member of Cochrane’s Methods Executive, the group that is responsible for directing the methods used within Cochrane Reviews. Read more about Matthew’s research interests here.
Joanne McKenzie, Monash University: Jo is a Professor and Head of the Methods in Evidence Synthesis Unit. She leads a programme of research on methods for evidence synthesis, with some key areas of interest being methods to present and synthesize results when meta-analysis is not possible, statistical methods for analysing and meta-analysing results from interrupted time series studies, and the development of reporting guidelines for different evidence synthesis products. She co-led the PRISMA 2020 statement and contributed to the development of the ROB-ME tool for assessing risk of bias due to missing evidence in meta-analyses. She is an active contributor to Cochrane, including being a Co-convenor of the Statistical Methods Group and an author of several chapters of the Cochrane Handbook for Systematic Reviews of Interventions. Read more about Jo’s research interests here.
Organisation
The Methods in Evidence Synthesis Unit (MESU) sits within the School of Public Health and Preventive Medicine at Monash University. The Unit’s mission is to develop, evaluate and make accessible optimal statistical and research methodology for evidence synthesis. The MESU team has led and contributed to major developments and understanding in evidence synthesis including developing reporting guidelines (PRISMA 2020, PRIOR, SWiM, and extensions to PRISMA 2020), risk of bias tools (ROB-ME, RoB 2), methods for synthesis when meta-analysis is not possible, methods for meta-analysing results from non-randomised studies, methods for overviews of systematic reviews, examining reproducibility in systematic reviews and bias in the review process. MESU staff regularly provide training to researchers, nationally and internationally, and collaborate on systematic reviews. MESU is funded through nationally competitive NHMRC and ARC grants.
Cochrane Australia sits within the School of Public Health and Preventive Medicine at Monash University and is a centre of expertise in evidence synthesis and the use of evidence to support healthcare decision-making. Cochrane Australia conducts evidence syntheses for government and public sector agencies, provides guidance and training on how to conduct evidence syntheses, and works with guideline developers and others to translate research into healthcare practice and policy.
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