Development and Validation of a PROM to capture holistic outcomes in Traditional, Complementary and Integrative Medicine - the Warwick Holistic Health Questionnaire (WHHQ-18)

Abstract

Abstract Introduction: Existing patient reported outcome measures (PROMs) do not capture all holistic outcomes observed in Traditional, Complementary and Integrative Medicine (TCIM). This study reports development and validation of a PROM to support research on craniosacral therapy (CST) and other TCIMs. Methods: Using a conceptual framework and items developed and evaluated with clients and practitioners in a CST setting, a questionnaire was developed and tested using mixed methods approaches. Evaluation included an iterative process. Psychometric tests: structural validity (exploratory factor analysis, EFA), internal consistency (Cronbach s alpha), convergent validity (correlations with Warwick-Edinburgh Mental Wellbeing Scale, Short Form-12v2 (SF-12), Harry Edwards Healing Impact Questionnaire), repeatability and responsiveness (t-tests; intra class coefficients, ICC). Results: The Warwick Holistic Health Questionnaire (WHHQ-18) was resolved covering mental, physical, emotional and spiritual wellbeing, self-awareness, engaging in life, responsibility for self, living in the moment and satisfaction with life. EFA revealed four correlated sub-scales. Internal reliability was good (alpha=0.852). Convergent validity showed strong positive correlation with other wellbeing measures, but no correlation with health-related quality of life (SF-12). Repeatability testing showed good agreement (ICC=0.822) and no differences in scores for test-retest (paired t-test: t=0.355, p=0.723). Responsiveness analysis showed significant differences in scores (paired t-test t=6.15, p Conclusion: WHHQ-18 is the first PROM developed\xa0for CST practice and captures outcomes important to TCIM more broadly. Good internal consistency, test-retest reliability and responsive at individual and group level make this new PROM an attractive resource for evaluators. Lack of convergent validity with SF-12 scales suggests WHHQ-18 be added to rather than replace HRQol measures in clinical studies.