Group analysis versus individual response: the inferential limits of randomized controlled trials.

Contemporary Clinical Trials
John M Kelley, Ted J Kaptchuk

Abstract

The randomized controlled trial (RCT) is the gold standard for assessing the efficacy of medical treatments. Over the past 50 years, RCT methodology has proven to be quite successful in identifying effective treatments and weeding out ineffective ones, thus transforming medicine from an intuitive art into an empirical science. However, the enormous success of the RCT has inadvertently contributed to a common inferential error that is insufficiently appreciated by some clinicians and researchers. Although RCTs can effectively distinguish between placebo and active treatment effects at the level of the group, contrary to intuition, this same disentanglement is much more difficult to achieve at the level of the individual. For individual patients it is surprisingly difficult to determine who is a treatment responder and who is not. Using data from a recent RCT, we illustrate the problem and detail its negative effects for research and clinical practice. Finally, we suggest strategies for minimizing these negative effects.

References

Apr 3, 1986·The New England Journal of Medicine·G GuyattS Pugsley
Jan 14, 1965·Psychopharmacologia·S FisherL C Park
Mar 27, 1999·Lancet·C van Weel, J A Knottnerus
Oct 23, 2004·BMJ : British Medical Journal·Stephen Senn
Mar 24, 2006·The New England Journal of Medicine·A John RushUNKNOWN STAR*D Study Team
Aug 8, 2009·Psychosomatic Medicine·John M KelleyTed J Kaptchuk

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Citations

Feb 22, 2012·Forschende Komplementärmedizin = Research in Complementary Medicine·Mones Abu-AsabHakima Amri
Mar 6, 2013·JPEN. Journal of Parenteral and Enteral Nutrition·L John Hoffer, Bruce R Bistrian
Dec 27, 2017·Statistical Methods in Medical Research·Rob KesselsJos Bloemers

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