Designing pragmatic trials-what can we learn from lessons learned?

Rolf H H Groenwold; Olaf M Dekkers

doi:10.1016/j.jclinepi.2017.06.006

Designing pragmatic trials-what can we learn from lessons learned?

J Clin Epidemiol. 2017 Oct:90:3-5. doi: 10.1016/j.jclinepi.2017.06.006. Epub 2017 Jun 16.

Authors

Rolf H H Groenwold¹, Olaf M Dekkers²

Affiliations

¹ Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, Utrecht 3584 CG, The Netherlands. Electronic address: r.h.h.groenwold@umcutrecht.nl.
² Department of Clinical Endocrinology and Metabolism, Leiden University Medical Centre, Albinusdreef 2, Leiden 2333 ZA, The Netherlands; Department of Clinical Epidemiology, Leiden University Medical Centre, Albinusdreef 2, Leiden 2333 ZA, The Netherlands; Department of Clinical Epidemiology, Aarhus University Hospital, Olof Palmes Allé 43-45, Aarhus DK-8200, Denmark.

PMID: 28629700
DOI: 10.1016/j.jclinepi.2017.06.006

Abstract

Pragmatic trials aim to inform clinical decision making by measuring the effect of a treatment in clinical practice. The purpose of the PRECIS-2 tool is to support in designing a truly pragmatic trial. We comment on a study by Forbes et al., who assessed the applicability of the PRECIS-2 tool. The tool will prove particularly useful when implemented in the process of trial design. However, it is yet unclear how e.g., possible dependencies between PRECIS domains, or conducting a pragmatic trial within an existing data registry (e.g., electronic health records) affect the applicability of the tool.

Keywords: Pragmatic trial; Randomised trial.

MeSH terms

Epidemiologic Methods*
Humans
Pragmatic Clinical Trials as Topic*
Registries
Research Design*