1. Validation of a Health-Related Quality of Life Questionnaire in Patients With Recurrent Clostridioides difficile Infection in ECOSPOR III, a Phase 3 Randomized Trial.
- Author
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Lapin B, Garey KW, Wu H, Pham SV, Huang SP, Reese PR, Wang E, and Deshpande A
- Subjects
- Humans, Female, Adolescent, Male, Quality of Life, Reproducibility of Results, Surveys and Questionnaires, Recurrence, Clostridium Infections drug therapy, Clostridioides difficile
- Abstract
Background: Debilitating symptoms of recurrent Clostridioides difficile infection (rCDI) often lead to long-term effects on health-related quality-of-life (HRQOL). In ECOSPOR III, SER-109, an investigational oral microbiome therapeutic, was superior to placebo in reducing rCDI. We investigated the validity, reliability, and responsiveness of a 32-item, CDI-specific questionnaire-the Clostridium difficile Quality of Life Survey (Cdiff32)-across mental, physical, and social domains in patients with rCDI., Methods: In this post hoc analysis of a phase 3 clinical trial, 182 outpatients with rCDI completed Cdiff32 and EQ-5D at baseline and at 1 and 8 weeks. Cdiff32 was evaluated for item performance, internal reliability, and convergent validity. To assess known-groups validity, Cdiff32 scores were compared by disease recurrence status at week 1; internal responsiveness was evaluated in the nonrecurrent disease group by 8 weeks by means of paired t test., Results: All 182 patients (mean age [standard deviation], 65.5 [16.5] years; 59.9% female) completed baseline Cdiff32. Confirmatory factor analysis identified 3 domains (physical, mental, and social relationships) with good item fit. High internal reliability was demonstrated (Cronbach α = 0.94 with all subscales >0.80). Convergent validity was evidenced by significant correlations between Cdiff32 subscales and EQ-5D (r = 0.29-0.37; P < .001). Cdiff32 differentiated patients by disease recurrence status at week 1 (effect sizes, 0.38-0.42; P < .05 overall), with significant improvement from baseline through week 8 in patients with nonrecurrent disease at week 1 (effect sizes, 0.75-1.02; P < .001 overall)., Conclusions: Cdiff32 is a valid, reliable, and responsive disease-specific HRQOL questionnaire that is fit for purpose for interventional treatment trials. The significant improvement in patients with nonrecurrent disease by 8 weeks demonstrates the negative impact of rCDI on HRQOL., Competing Interests: Potential conflicts of interest. B. L. reports payments to self for being on the editorial board of Quality of Life Research, Anesthesia & Analgesia, and Chest. K. W. G. reports grants or contracts from Seres Health, Paratek Pharmaceuticals, Acurx Pharmaceuticals, and Summit Pharmaceuticals, all outside the submitted work. S. V. P., S. P. H., and P. R. R. are health economics and outcomes research (HEOR) consultants (at AESARA) for Seres Therapeutics. P. R. R. reports being a freelance consultant paid by Aesara to provide consulting support to Seres Therapeutics. E. W. reports employee stock options from Seres Therapeutics. A. D. is a consultant for Merck, has received research funding from The Clorox Company, and reports personal stocks from Seres Therapeutics. H. W. reports no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2023
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