Summary
Real world evidence can be defined as evidence derived from routinely collected data, that is data not collected for the purpose of research, for example hospital records or administrative claims data. Most studies using this data in health research are currently non-randomized. In a series of projects, we evaluate the challenges of using such evidence for comparative effectiveness research and healthcare decision-making.

Publications

• Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey. Hemkens LG, Contopoulos-Ioannidis DG, Ioannidis JP. BMJ. 2016 Feb 8;352:i493. doi: 10.1136/bmj.i493.
• Routinely collected data and comparative effectiveness evidence: promises and limitations. Hemkens LG, Contopoulos-Ioannidis DG, Ioannidis JPA. CMAJ. 2016 May 17;188(8):E158-E164. doi: 10.1503/cmaj.150653. Epub 2016 Feb 16.
• Current use of routinely collected health data to complement randomized controlled trials: a meta-epidemiological survey. Hemkens LG, Contopoulos-Ioannidis DG, Ioannidis JP. CMAJ Open. 2016 Apr 6;4(2):E132-40. doi: 10.9778/cmajo.20150036. eCollection 2016 Apr-Jun.
• Interpretation of epidemiologic studies very often lacked adequate consideration of confounding. Hemkens LG, Ewald H, Naudet F, Ladanie A, Shaw JG, Sajeev G, Ioannidis JPA. J Clin Epidemiol. 2018 Jan;93:94-102. doi: 10.1016/j.jclinepi.2017.09.013. Epub 2017 Sep 21.
• Non-randomized studies using causal-modelling may give different answers than RCTs: a meta-epidemiological study. Ewald H, Ioannidis JP, Ladanie A, Cord KM, Bucher HC, Hemkens LG. J Clin Epidemiol. 2019 Nov 5. pii: S0895-4356(19)30263-X. doi: 10.1016/j.jclinepi.2019.10.012. [Epub ahead of print]

Basel research team
Lars Hemkens