Document Detail

Threats to validity in randomized clinical trials.
MedLine Citation:
PMID:  10686575     Owner:  NLM     Status:  MEDLINE    
The purposes of this article are to present an overview of randomized clinical trials (RCTs) and describe some of the methodological problems inherent in using RCTs in nursing research. Many nursing intervention studies are fraught with problems that defy the stringent control criteria required for RCTs, leading to biased estimates of intervention efficacy. Five threats to validity in RCTs are presented, including problems related to (a) differential dropout, (b) random assignment, (c) identifying and maintaining an adequate control condition, (d) nonadherence to research protocols, and (e) assessment of clinically meaningful change. Three strategies are recommended for addressing some of the problems posed by RCTs and improving inference.
L Fogg; D Gross
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Publication Detail:
Type:  Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Research in nursing & health     Volume:  23     ISSN:  0160-6891     ISO Abbreviation:  Res Nurs Health     Publication Date:  2000 Feb 
Date Detail:
Created Date:  2000-03-22     Completed Date:  2000-03-22     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7806136     Medline TA:  Res Nurs Health     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  79-87     Citation Subset:  IM; N    
Copyright Information:
Copyright 2000 John Wiley & Sons, Inc. 23:79-87, 2000
Department of Psychology and Psychiatry, Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL, USA.
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MeSH Terms
Clinical Nursing Research / methods*
Clinical Protocols
Guideline Adherence
Patient Dropouts
Random Allocation
Randomized Controlled Trials as Topic / methods*
Reproducibility of Results
Research Design
Grant Support

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