Development of Items for the Patient-Reported Healing Context in CAM

Purpose: The goal of this project was to develop item banks to examine contextual factors of healing in complementary and alternative medicine (CAM) from the patient perspective. The mixed (qualitative and quantitative) methods established by the NIH Roadmap initiative, Patient-Reported Outcomes Measurement Information System (PROMIS®) were used for this purpose.

Methods: We developed conceptual hierarchies and literature search terms based on prior factor analytic work and information from six focus groups of CAM patients, conventional medicine patients, and local community members. A team of CAM practitioners and PROMIS researchers reviewed relevant literature and collected extant instruments and items. Items were organized conceptually and revised for consistency. Cognitive interviews with patients and community members elicited further feedback on item comprehension, contributing toward final revisions of conceptual domains and individual items.

Results: Review of 14,864 publications yielded 535 instruments and a pool of 16,000+ items that were categorized into 7 domains: Optimism/Pessimism, Spirituality, Locus of Control, Treatment Expectancies, Healthcare Environment, Patient-Provider Encounter, and Attitudes towards Health and Wellness. Final item pools for each of these constructs (ranging from 43 to 68 items) were created.

Conclusion: Item pools developed through this process reflect a broad understanding of constructs important in the healing context of bothCAM and conventional treatment settings. These item pools will be calibrated using models from item response theory (IRT) using a sample of 1400 community respondents, 100 CAM patients, and 100 patients treated in a primary care clinic.

Significance: Valid tools assessing patient attitudes, perceptions of patient-provider relations, and the healing environment have the potential to improve efficacy trials of both CAM and conventional medicine. They will be helpful in identifying moderators of treatment outcome and dismantling placebo effects.

Presented in 2012 at the University of Pittsburgh.