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Scientific Challenges in the Application of Randomized Trials

Scientific Challenges in the Application of Randomized Trials In recent years, scientific challenges in the application of randomized trials have become more apparent, especially with the extension of such trials to the assessment of nondrug treatments, such as health education, psychotherapy, and health care provision. Six issues (individual v group randomization, blinding and unblinding, the effect of trial participation on outcome, selective subject participation, treatment compliance, and standardized v individualized treatment) are discussed in terms of their impact on internal validity, generalizability (external validity), and clinical relevance. Specific design strategies may be necessary to enhance these methodological and clinical desiderata. Attention to these challenges should lead to improvements in future randomized trials. (JAMA 1984;252:2739-2745) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Scientific Challenges in the Application of Randomized Trials

Kramer, Michael S.; Shapiro, Stanley H.
JAMA , Volume 252 (19) – Nov 16, 1984
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References (27)

Publisher
American Medical Association
Copyright
Copyright © 1984 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.1984.03350190041017
Publisher site
See Article on Publisher Site

Abstract

In recent years, scientific challenges in the application of randomized trials have become more apparent, especially with the extension of such trials to the assessment of nondrug treatments, such as health education, psychotherapy, and health care provision. Six issues (individual v group randomization, blinding and unblinding, the effect of trial participation on outcome, selective subject participation, treatment compliance, and standardized v individualized treatment) are discussed in terms of their impact on internal validity, generalizability (external validity), and clinical relevance. Specific design strategies may be necessary to enhance these methodological and clinical desiderata. Attention to these challenges should lead to improvements in future randomized trials. (JAMA 1984;252:2739-2745)

Journal

JAMA – American Medical Association

Published: Nov 16, 1984

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