Improving the external validity of clinical trials: the case of multiple chronic conditions

TitleImproving the external validity of clinical trials: the case of multiple chronic conditions
Publication TypePublished Journal Article
2013
AuthorsFortin M, Smith SM
JournalJournal of Comorbidity
Volume3
Issue2
Start Page30
Pagination30-35
Date Published12/2013
Type of ArticlePublished Journal Article
Keywordsclinical trials, Comorbidity, external validity, internal validity, multimorbidity, multiple chronic conditions
Abstract

The U.S. Department of Health and Human Services vision and strategic framework on multiple chronic conditions(MCCs) incorporates recommendations designed to facilitate research that will improve our knowledge about interventions and systems that will benefit individuals with MCCs (or multimorbidity). The evidence base supporting the management of patients with MCCs will be built through intervention trials specifi cally designed to address multimorbidity and identifi cation of MCCs in participants across the clinical trial range. This article specifically focuses on issues relating to external validity with specifi c reference to trials involving patients with MCCs. The exclusion of such patients from clinical trials has been well documented. Randomized control trials (RCTs) are considered the “gold standard” of evidence, but may have drawbacks in relation to external validity, particularly in relation to multimorbidity. It may, therefore, be necessary to consider a broader range of research methods that can provide converging evidence on intervention effects to address MCCs. Approaches can also be taken to increase the usefulness of RCTs in general for providing evidence to inform multimorbidity management. Additional improvements to RCTs would include better reporting of inclusion and exclusion criteria and participant characteristics in relation to MCCs. New trials should be considered in terms of how they will add to the existing evidence base and should inform how interventions may work in different settings and patient groups. Research on treatments and interventions for patients with MCCs is badly needed. It is important that this research includes patient-centered measures and that generalizability issues be explicitly addressed.

URLhttp://jcomorbidity.com/index.php/test/article/view/27
DOI10.15256/joc.2013.3.27