Responsiveness Evaluation and Recommendation for Responder Thresholds for Endometriosis Health Profile-30: Analysis of Two Phase III Clinical Trials

Pokrzywinski R, Robin Pokrzywinski, Ahmed M. Soliman, Chen J, Jun Chen, Snabes MC, Michael C. Snabes, Taylor HS, Huge S. Taylor, Karin S. Coyne, Coyne KS
Journal of women's health (2002) · 2019 · vol. 29(2) , pp. 253–261 · doi:10.1089/jwh.2019.7788 · PMID:31855102 · W2995736951
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This analysis of two clinical trials established responder thresholds for the EHP-30 to evaluate treatment efficacy, recommending score changes between -20 and -35 for meaningful improvement.

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Abstract

Objective: To evaluate the responsiveness of the Endometriosis Health Profile-30 (EHP-30) and ascertain score changes that are indicative of response to treatment. A post hoc analysis of two Phase III, double-blind, placebo-controlled, randomized clinical trials among women with moderate-to-severe endometriosis-associated pain (Elaris Endometriosis I and II [EM-I and EM-II]). Materials and Methods: EHP-30 core items and sexual relationship module were administered at day 1, month 3 (M3), and month 6 (M6) to monitor patient-reported impacts of endometriosis-related pain. A seven-response level Patient Global Impression of Change (PGIC) was administered at M3 and M6. Dysmenorrhea (DYS), nonmenstrual pelvic pain (NMPP), and dyspareunia (DYSP) were collected using a daily diary. Three psychometric approaches, “triangulation,” were used to suggest responder thresholds for the EHP-30 domains. The three approaches were anchor- and distribution-based analyses and use of clinically relevant indicators (DYS, NMPP, DYSP). Results: EM-I and EM-II enrolled 871 and 815 women, respectively. All EHP-30 domains improved during the trials (M3, M6). Differences (p < 0.001) for all EHP-30 domains were found among the PGIC responses at M3 and M6, indicating greater change was associated with greater EHP-30 improvements. Large effect sizes were noted for all EHP-30 domains (EM-I range −0.59 to −1.80; EM-II range −0.52 to −1.59). EHP-30 thresholds of meaningful change ranged from −20 to −35, with greater changes indicating greater improvement in health status. Conclusion: Responder thresholds by EHP-30 domain are recommended to evaluate treatment efficacy. Clinicians can individualize goals of treatment by EHP-30 domain and track changes using the EHP-30.

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Outcome instruments

EHP-30

Condition tags

dysmenorrheadyspareuniaendometriosis

MeSH descriptors

Endometriosis Surveys and Questionnaires Adult Double-Blind Method Dysmenorrhea Dysmenorrhea Dyspareunia Dyspareunia Endometriosis Endometriosis Female Health Status Humans Hydrocarbons, Fluorinated Hydrocarbons, Fluorinated Psychometrics Pyrimidines Pyrimidines Quality of Life Surveys and Questionnaires

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