Methodological gaps in the assessment of risk minimization interventions: a systematic review
Version of Record online: 24 FEB 2014
© 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Pharmacoepidemiology and Drug Safety
Volume 23, Issue 6, pages 572–579, June 2014
How to Cite
Gridchyna, I., Cloutier, A.-M., Nkeng, L., Craig, C., Frise, S. and Moride, Y. (2014), Methodological gaps in the assessment of risk minimization interventions: a systematic review. Pharmacoepidem. Drug Safe., 23: 572–579. doi: 10.1002/pds.3596
- Issue online: 3 JUN 2014
- Version of Record online: 24 FEB 2014
- Manuscript Accepted: 20 JAN 2014
- Manuscript Revised: 17 JAN 2014
- Manuscript Received: 20 JUN 2013
- risk minimization intervention;
- therapeutic risk management;
Since the introduction of therapeutic risk management regulatory guidance, an increase in the number of risk minimization interventions (RMIs) published in the literature has been observed. Methods used to evaluate their effectiveness remain, however, poorly examined.
This paper aimed to conduct a literature review on the methods of evaluation of effectiveness of RMIs and to identify methodological gaps.
The search was conducted using MEDLINE and Embase between 1 January 2000 and 31 December 2010, and updated on 1 April 2013. The following characteristics were extracted from each study: target population for the RMI, target population for the assessment of effectiveness, study design, data sources, and effectiveness outcome(s).
A total of 188 unique RMIs were identified in the literature, of which effectiveness was evaluated in only 65 (34.6%) at the time of publication. The largest proportion of studies reviewed (n = 49, 75.4%) attempted to evaluate changes in behavior through prescribing or laboratory test practices. One quarter of studies evaluated the effect of RMIs on the occurrence of adverse events. Only a minority of studies used robust designs, such as randomized controlled trials (n = 6, 9.2%) or a quasi-experimental design with a parallel comparison group (n = 8, 12.3%).
Lack of robust methodological design used in published studies on RMI effectiveness evaluation is an important methodological gap in the evaluation of RMI effectiveness. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.