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Generalizing from clinical trial data: A case study. The risk of suicidality among pediatric antidepressant users
Author(s) -
Greenhouse Joel B.,
Kaizar Eloise E.,
Kelleher Kelly,
Seltman Howard,
Gardner William
Publication year - 2008
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.3218
Subject(s) - generalizability theory , context (archaeology) , clinical trial , randomized controlled trial , antidepressant , clinical practice , psychology , computer science , medicine , psychiatry , family medicine , developmental psychology , paleontology , anxiety , biology
Abstract For the results of randomized controlled clinical trials (RCTs) and related meta‐analyses to be useful in practice, they must be relevant to a definable group of patients in a particular clinical setting. To the extent this is so, we say that the trial is generalizable or externally valid. Although concern about the generalizability of the results of RCTs is often discussed, there are few examples of methods for assessing the generalizability of clinical trial data. In this paper, we describe and illustrate an approach for making what we call generalizability judgments and illustrate the approach in the context of a case study of the risk of suicidality among pediatric antidepressant users. Copyright © 2008 John Wiley & Sons, Ltd.