Patient-reported outcome research
Efficace F, Horneber M, Lejeune S, Van Dam F,Leering S, Rottmann M, Aaronson NK. Improvement is needed in the methodological quality of patient-reported outcome research in complementary and alternative medicine in oncology. J Clin Epidemiol. 2006 Dec;59(12):1257-65.
Background
No evidence exists regarding the methodological robustness of patient-reported outcomes (PROs) evaluation in trial-based complementary and alternative medicine (CAM) studies.
Materials and Methods: CAM randomized controlled trials with a PRO endpoint were considered for evaluation and were retrieved in 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.
Results
Forty four RCTs were identified: 6 studies involved alternative medical systems, 14 involved mind body interventions, 15 dealt with biologically based therapies and 7 and 2 dealt with manipulative and body based-methods and energy therapies respectively. Eighty-nine percent of studies used a given PRO as a primary endpoint and the remaining 11% included the PRO as the secondary endpoint. Although 84% used a previously validated PRO questionnaire only 37% stated an a priori hypothesis and 20% addressed clinical significance of the outcomes. Overall, whilst 64% of the studies showed a number of major methodological limitations, 36% of these were accurate in terms of reporting.
Conclusion
There is still large room for improvement when conducting a PRO evaluation in CAM research and investigators are encouraged to address a number of issues identified in this work.
