Sources of bias in randomized trials and non-randomized studies of interventions: a causal inference perspective

Friday, 16 March 2018

Presented by: Jonathan Sterne, Professor of Medical Statistics and Epidemiology at the University of Bristol, and international authority in methods for evidence evaluation and synthesis.

The assessment of risk of bias in randomized trials (RCTs) and non-randomized studies of interventions (NRSI) has evolved substantially in recent years. These changes are reflected in newly available tools (ROB 2.0 for randomized trials and ROBINS-I for NRSI; see These new tools are based on key concepts in modern causal inference.  In this course Jonathan will:

•    Introduce the key features of the RoB 2.0 and ROBINS-I tools (domain-based bias assessments, use of signalling questions and algorithms to guide risk of bias judgements), and derivation of the overall risk of bias in a specified result).

•    Describe the domains of bias appropriate to assessment of RCTs and NRSI.

•    Describe how modern epidemiological understanding of confounding (including time-varying confounding), selection bias and misclassification bias informs the new tools.

•    Explain the importance of specification of whether the effect of interest is that of assignment to intervention (the “intention to treat” effect) or that of starting and adhering to intervention (the “per protocol” effect).

Participants will use one of the new tools to assess risk of bias in either a RCT or an NRSI.

Who should attend?
This workshop is designed for clinical researchers, epidemiologists and biostatisticians who have at least some background in elementary biostatistics and basic epidemiological concepts.

Venue Details
Murdoch Children's Research Institute
Royal Children's Hospital
Walford/Cox Room (Rooms WL5.2.01 & WL5.2.03)
Level 5
50 Flemington Rd, Parkville  Vic  3052.
Please note:  Report to MCRI reception on Ground floor and wait for staff member escort to Level 5.  Security pass is required to access lifts.
(See map attached)


Click here to see workshop fees.

Registration now open via Trybooking

Please note the following:

  • Early bird rate until 6/3/18.
  • Students must be full time.  ID number is required to register.
  • ViCBiostat post docs and PhD students - please refer to email from Marian regarding registration process.
  • MCRI staff may request a cost centre transfer but must complete online registration process for administration purposes.  Please contact Marian Chandler for details regarding the process prior to registering.  
  • All prices inclusive of GST.
  • Registration fee includes catering.
  • Course runs from 9.00am-5.00pm
  • A small booking fee applies in addition to prices stated.
  • Cancellation policy: refund of registration fee less 25% if cancellation within 1 week of course. 

    Contact Marian Chandler for any questions regarding registration.

Professor Jonathan Sterne

Prof. Jonathan Sterne

Department of Population Health Sciences
University of Bristol

Jonathan Sterne is Professor of Medical Statistics and Epidemiology in the University of Bristol’s Department of Population Health Sciences, and Deputy Director of the NIHR Bristol Biomedical Research Centre. Jonathan has a longstanding interest in methods for systematic reviews and meta-analysis, led development of the ROBINS-I tool for assessing risk of bias in non-randomised studies of interventions, and contributed to the development of the Cochrane risk of bias tool for randomised trials. He also leads a large collaboration of HIV cohort studies that led to advances in our understanding of prognosis of HIV-positive people in the era of effective antiretroviral therapy. He has authored highly-cited papers on causal inference, including methods for instrumental variable analyses of Mendelian randomisation studies. Other research interests include methodology for epidemiology and health services research and the epidemiology of asthma and allergic diseases.

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