Objective: To evaluate the methodological robustness of patient-reported outcomes (PROs) evaluation in complementary and alternative medicine (CAM) randomized controlled trials (RCTs) in oncology. Study Design and Setting: CAM RCTs with a PRO endpoint were retrieved from a number of electronic databases. CAM interventions were defined according to the five major categories of the National Center for Complementary and Alternative Medicine. The "Minimum Standard Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials" was used to assess the quality of the PRO reporting in these trials. Results: Forty-four RCTs enrolling 4,912 patients were identified: six studies involved alternative medical systems, 14 involved mind body interventions, 15 dealt with biologically-based therapies, seven involved manipulative and body-based methods, and two energy therapies. Eighty-nine percent of studies used a PRO as a primary endpoint and 59% documented PRO missing data. Although 84% of the studies used a validated PRO questionnaire, only 37% stated an a priori hypothesis and 20% addressed clinical significance of the outcomes. Overall, 64% of the studies analyzed exhibited a number of methodological drawbacks. Conclusions: To facilitate the interpretation of results from such CAM RCTs, investigators are encouraged to pay greater attention to key methodological issues as identified in this study. © 2006 Elsevier Inc. All rights reserved.
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