TY - JOUR
T1 - Justification of exclusion criteria was underreported in a review of cardiovascular trials
AU - Schmidt, Amand F.
AU - Groenwold, Rolf H. H.
AU - van Delden, Johannes J. M.
AU - van der Does, Yuri
AU - Klungel, Olaf H.
AU - Roes, Kit C. B.
AU - Hoes, Arno W.
AU - van der Graaf, Rieke
PY - 2014
Y1 - 2014
N2 - 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. © 2014 Published by Elsevier.
AB - 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. © 2014 Published by Elsevier.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84899517631&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/24613498
U2 - https://doi.org/10.1016/j.jclinepi.2013.12.005
DO - https://doi.org/10.1016/j.jclinepi.2013.12.005
M3 - Review article
C2 - 24613498
SN - 0895-4356
VL - 67
SP - 635
EP - 644
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
IS - 6
ER -