TY - JOUR
T1 - Focus on research methods threats to validity in randomized clinical trials
AU - Fogg, Louis
AU - Gross, Deborah
PY - 2000/2
Y1 - 2000/2
N2 - 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.
AB - 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.
KW - Randomized clinical trials
KW - Threats to validity of research
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U2 - 10.1002/(sici)1098-240x(200002)23:1<79::aid-nur9>3.0.co;2-r
DO - 10.1002/(sici)1098-240x(200002)23:1<79::aid-nur9>3.0.co;2-r
M3 - Article
C2 - 10686575
AN - SCOPUS:0034132265
SN - 0160-6891
VL - 23
SP - 79
EP - 87
JO - Research in Nursing and Health
JF - Research in Nursing and Health
IS - 1
ER -