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J Clin Epidemiol. 2014 Jun;67(6):635-44. doi: 10.1016/j.jclinepi.2013.12.005. Epub 2014 Mar 5.

Justification of exclusion criteria was underreported in a review of cardiovascular trials.

Author information

1
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Stratenum 6.131, P.O. Box 85500, 3508 GA Utrecht, The Netherlands; Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, P.O. Box 80082, 3508 TB Utrecht, The Netherlands; Department of Farm Animal Health, Faculty of Veterinary Medicine, Utrecht University, Yalelaan 107, Utrecht 3584 CL, The Netherlands. Electronic address: a.f.schmidt@umcutrecht.nl.
2
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Stratenum 6.131, P.O. Box 85500, 3508 GA Utrecht, The Netherlands; Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, P.O. Box 80082, 3508 TB Utrecht, The Netherlands.
3
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Stratenum 6.131, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
4
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Stratenum 6.131, P.O. Box 85500, 3508 GA Utrecht, The Netherlands; Department of Emergency Medicine, Erasmus University Medical Center, 's Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands.

Abstract

OBJECTIVES:

Ethical guidelines for human subject research require that the burdens and benefits of participation be equally distributed. This study aimed to provide empirical data on exclusion of trial participants and reasons for this exclusion. As a secondary objective, we assessed to what extent exclusion affects generalizability of study results.

STUDY DESIGN AND SETTING:

Review of trials on secondary prevention of cardiovascular events.

RESULTS:

One hundred thirteen trials were identified, of which 112 reported exclusion criteria. One study justified the exclusion criteria applied. Ambiguous exclusion criteria due to the opinion of the physician (28 of 112 = 25%) or physical disability (12 of 112 = 11%) were reported. Within groups of trials that studied similar treatments (ie, beta-blocker, clopidogrel, or statin therapy), baseline characteristics differed among trials. For example, the proportion of women ranged between 23.1-47.4%, 2.1-38.9%, and 10.6-50.6% for the clopidogrel, beta-blocker, and statin trials, respectively. Nevertheless, no evidence was found for heterogeneity of treatment effects.

CONCLUSION:

Almost none of the articles justified the applied exclusion criteria. No evidence was found that inclusion of dissimilar participants affected generalizability. To allow for a normative discussion on equitable selection of study populations, researchers should not only report exclusion criteria but also the reasons for using these criteria.

KEYWORDS:

Ethics; Exclusion criteria; Generalizability; Human experimentation; Medical; Randomized controlled trials; Research

PMID:
24613498
DOI:
10.1016/j.jclinepi.2013.12.005
[Indexed for MEDLINE]
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