10 Sep Level of Pragmatism Increased in Cardiovascular Randomized Clinical Rrials Over Two Decades
MedicalResearch.com Interview with:
Nariman Sepehrvand, MD
Research Associate & PhD Candidate
Canadian VIGOUR Centre, and Department of Medicine,
University of Alberta, Edmonton, Canada
Medical Research: Can you tell us a little bit about the background of this study?
Dr. Sepehrvand: As you know the traditional randomized clinical trials (RCT) have been criticized from time to time for the lack of generalizability, high costs and lengthy processes. Pragmatic trials with the primary goal of informing patients, clinicians, healthcare administrators and policy-makers about the effectiveness of biomedical and behavioral interventions have the potential to address those shortcomings by enrolling a population representative of the populations in which the intervention will be eventually applied to and by streamlining and simplifying the trial-related procedures. We knew about the challenges that trialists encounter in the design and implementation of pragmatic trials, so we were wondering how pragmatic or explanatory are cardiovascular (CV) RCTs and if there has been any change over time!
Medical Research: What are the main findings?
Dr. Sepehrvand: The good news is that based on this study which assessed 616 cardiovascular RCTs that were published in six major medical and CV journals during 2000, 2005, 2010, and 2015, there has been an increase in the level of pragmatism in these trials over time. Although the increase is significant, it has been slow and modest! For this assessment, we used the Pragmatic Explanatory Continuum Index Summary (PRECIS)-2 tool which is developed by an international group of trialists and methodologists, and assesses the design of trials in 9 different domains including eligibility, recruitment, setting, organization, intervention delivery, intervention adherence, follow-up, primary outcome, and analysis. In our study, the increase occurred mainly in the eligibility, setting, flexibility of intervention delivery, and primary endpoint domains of the trial design.
Medical Research: What should readers take away from your report?
Dr. Sepehrvand: As you know, we have a gap in our evidence to support our practice. We need more trials with reliable, generalizable and timely findings. Knowing more about our current trials will help us in the design and delivery of CV trials that are required for the broader application of the studied interventions.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Sepehrvand: Now that we know which trial design domain had increased pragmatism over the last 2 decades, we might want to explore the reasons or hurdles that prevented other domains from experiencing a similar increase in pragmatism. Also, in terms of how we report trials, we think it’s a good idea to require investigators to include the PRECIS-2 wheel assessment of their trial with the rationale behind the assigned scores in the same way journals require reporting CONSORT checklist.
Medical Research: Is there anything else you would like to add? Any disclosures?
Dr. Sepehrvand: Adjudicating 616 RCTs was not an easy task and I would like to thank the adjudicators of this study for their great help and contribution.
Citation: Sepehrvand N, Alemayehu W, Das D, et al. Trends in the Explanatory or Pragmatic Nature of Cardiovascular Clinical Trials Over 2 Decades. JAMA Cardiol. Published online September 01, 2019. doi:10.1001/jamacardio.2019.3604
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