Developing a self-report outcome measure for complementary and alternative medicine.

OBJECTIVE: Our objective was to develop a pilot measure of subjective outcomes of complementary and alternative medicine (CAM). Current options for assessing subjective outcomes in CAM are either too burdensome or fail to represent diverse outcomes. A single measure specifying common, patient-reported outcomes of CAM would be of value.

DESIGN: We conducted a three-phase instrument development study. In phase I, 30 CAM-receiving patients and 12 CAM practitioners completed a battery of standardized measures. Participants identified those standardized items relevant to CAM outcome and suggested additional outcome issues. In phase II, 20 CAM-receiving patients completed a Q-sort to determine which items from phase I were most relevant to CAM outcome. In phase III, five experts reviewed the items from phase II for content validity.

SETTING: An integrative medicine clinic at a private, Midwest US hospital.

PARTICIPANTS: CAM patients, practitioners, and researchers and an outcomes measurement specialist.

RESULTS: In phase I, 30 standardized items were judged relevant to CAM outcome, and 8 additional items were suggested. In phase II, 29 of the 38 phase I items were deemed at least "moderately relevant" to CAM outcome. In phase III, experts added 15 items, dropped 9 items, and altered 3 items. The 35 resulting items were classified into content domains, forming a testable, pilot version of the instrument.