Development and validation of a PROM to capture holistic outcomes in traditional, complementary and integrative medicine - The Warwick Holistic Health Questionnaire (WHHQ-18)

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.\ud \ud 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).\ud \ud 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.\ud \ud 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 < 0.001) with 46% of participants having an effect size of 0.5 or more.\ud \ud Conclusion: WHHQ-18 is the first PROM developed for 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.