TY - JOUR
T1 - Methodological issues in trials of complementary and alternative medicine interventions
AU - Sikorskii, Alla
AU - Wyatt, Gwen
AU - Victorson, David
AU - Faulkner, Gwen
AU - Rahbar, Mohammad Hossein
PY - 2009/11
Y1 - 2009/11
N2 - Background: Complementary and alternative medicine (CAM) use is widespread among cancer patients. Information on safety and efficacy of CAM therapies is needed for both patients and healthcare providers. Well-designed randomized clinical trials of CAM therapy interventions can inform both clinical research and practice. Objectives: The aim of this study was to review important issues that affect the design of randomized clinical trials for CAM interventions. Methods: Using the methods component of the Consolidated Standards for Reporting Trials as a guiding framework and a National Cancer Institute-funded reflexology study as an exemplar, methodological issues related to participants, intervention, Objectives, outcomes, sample size, randomization, blinding, and statistical methods were reviewed. Discussion: Trials of CAM interventions designed and implemented according to appropriate methodological standards will facilitate the needed scientific rigor in CAM research. Interventions in CAM can be tested using proposed methodology, and the results of testing will inform nursing practice in providing safe and effective supportive care and in improving the well-being of patients.
AB - Background: Complementary and alternative medicine (CAM) use is widespread among cancer patients. Information on safety and efficacy of CAM therapies is needed for both patients and healthcare providers. Well-designed randomized clinical trials of CAM therapy interventions can inform both clinical research and practice. Objectives: The aim of this study was to review important issues that affect the design of randomized clinical trials for CAM interventions. Methods: Using the methods component of the Consolidated Standards for Reporting Trials as a guiding framework and a National Cancer Institute-funded reflexology study as an exemplar, methodological issues related to participants, intervention, Objectives, outcomes, sample size, randomization, blinding, and statistical methods were reviewed. Discussion: Trials of CAM interventions designed and implemented according to appropriate methodological standards will facilitate the needed scientific rigor in CAM research. Interventions in CAM can be tested using proposed methodology, and the results of testing will inform nursing practice in providing safe and effective supportive care and in improving the well-being of patients.
KW - Complementary and alternative therapies
KW - Methodology
UR - http://www.scopus.com/inward/record.url?scp=73549084728&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=73549084728&partnerID=8YFLogxK
U2 - 10.1097/NNR.0b013e3181bf15fe
DO - 10.1097/NNR.0b013e3181bf15fe
M3 - Article
C2 - 19918155
AN - SCOPUS:73549084728
SN - 0029-6562
VL - 58
SP - 444
EP - 451
JO - Nursing Research
JF - Nursing Research
IS - 6
ER -