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Randomized Controlled Trial
. 2023 Apr 4;7(1):34.
doi: 10.1186/s41687-023-00552-4.

Validation and meaningful within-patient change in work productivity and activity impairment questionnaire (WPAI) for episodic or chronic migraine

Janet H Ford  1 , Wenyu Ye  2 , David W Ayer  1 , Xiaojuan Mi  3 , Swati Bhandari  1 , Dawn C Buse  4 , Richard B Lipton  4   5
Affiliations
Randomized Controlled Trial

Validation and meaningful within-patient change in work productivity and activity impairment questionnaire (WPAI) for episodic or chronic migraine

Janet H Ford et al. J Patient Rep Outcomes. .

Abstract

Background: No available studies demonstrate validity and meaningful change thresholds of Work Productivity and Activity Impairment (WPAI) questionnaire in patients with migraine. In this post-hoc analysis, we assessed reliability, validity, responsiveness, and meaningful within-patient change from baseline to Month 3 for Work Productivity and Activity Impairment (WPAI) domain scores in patients with episodic migraine (EM) or chronic migraine (CM).

Method: The Phase 3, multicenter, randomized, double-blind, placebo-controlled CONQUER study (NCT03559257, N = 462) enrolled patients with EM or CM who failed two to four categories of prior preventive medication in past ten years. The analyses were performed for WPAI domain scores (absenteeism, presenteeism, overall work productivity, and non-work-related activity impairment). Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) domain scores (Role Function-Restrictive [RFR] and Role Function-Preventive [RFP]), and monthly migraine headache days were used as anchors. Responder criteria were changes from baseline to Month 3 for each of these anchors and were defined as: increase in MSQ-RFR by ≥ 25.71 points and MSQ-RFP by ≥ 20.00 points and a 50% reduction in monthly migraine headache days. Assessments were performed for overall population, and patients with EM or CM. The meaningful change threshold was determined based on Youden index, Phi coefficient and sensitivity.

Results: Of 462 randomized patients, 444 who completed WPAI questionnaire were included in post-hoc analysis. Test-retest reliability over 3 months in a stable subgroup revealed moderate correlations for non-work-related Activity Impairment (ICC = 0.446) presenteeism (ICC = 0.438) and a fair correlation for overall work productivity loss (ICC = 0.360). At baseline, all correlations between WPAI domain scores and continuous anchor variables exceeded recommended threshold of ≥ 0.30, except for WPAI domain scores with number of monthly migraine headache days. Patients achieving pre-specified responsiveness thresholds for monthly migraine headache days, and MSQ-RFP, MSQ-RFR from baseline to Month 3 (responders) showed significant improvements in WPAI domain scores compared with non-responders (P < 0.001). The meaningful change thresholds of -20 (% unit) were identified for WPAI domain scores.

Conclusion: In conclusion, WPAI has sufficient validity, reliability, responsiveness, and appropriate interpretation standards to assess the impact of EM or CM on presenteeism and overall work productivity loss and non-work-related activity impairment.

Trial registration: NCT number of CONQUER study, NCT03559257.

Keywords: Absenteeism; Chronic migraine; Episodic migraine; Meaningful change; Non-work-related activity impairment; Patient-reported outcome; Presenteeism; Validation; Work Productivity and Activity Impairment questionnaire (WPAI); Work productivity loss.

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Conflict of interest statement

WY, and DWA are employees and minor stockholders of Eli Lilly and Company. JHF is a former employee of Eli Lilly and Company and was associated with Eli Lilly till the time of manuscript submission. Her current affiliation is Agios. XM is an employee of Tech Data Services Company and performs contracted work for Eli Lilly and Company. SB was an employee of Eli Lilly and Company during the conduct of the study. DCB has received research support from Amgen, the Food and Drug Administration and the National Headache Foundation, and is a consultant to Allergan, Amgen, Eli Lilly, Lundbeck and Teva. She is a section editor for Current Pain and Headache Reports. RBL has received funding from Alder Biopharmaceuticals, Allergan, American Academy of Neurology (other activities), American Headache Society, Amgen, Autonomic Technologies (speaking and teaching), Avanir Pharmaceuticals, Biohaven Pharmaceuticals, Boston Scientific, Dr. Reddy's Laboratories, ElectroCore, Eli Lilly and Company, eNeura Therapeutics, GlaxoSmithKline, Headache (other activities) (personal fees), Informa (speaking and teaching), Merck & Co, Inc., Migraine Research Foundation, National Headache Foundation, Neurology (board membership) (serves on editorial board), National Institute on Aging (other activities), National Institute of Neurological Disorders and Stroke (other activities), Novartis (speaking and teaching) (other activities) (personal fees), Pernix, Teva Pharmaceuticals, Vedanta, and Wolff's Headache 7th and 8th Edition, Oxford University Press, 2009.

Figures

Fig. 1
Fig. 1
Youden’s index for WPAI domain scores improvement at Month 3 for selected anchors (Overall population). WPAI scores are presented as % unit. Abbreviations: MHD monthly migraine headache days, MSQ Migraine-Specific Quality of Life questionnaire, RFP Role Function-Preventive, RFR Role Function-Restrictive, WPAI Work Productivity and Activity Impairment questionnaire, YI Youden index
Fig. 2
Fig. 2
Youden’s index for WPAI domain scores improvement at Month 3 for selected anchors (EM). WPAI scores are presented as % unit. Abbreviations: EM episodic migraine, MHD monthly migraine headache days, MSQ Migraine-Specific Quality of Life questionnaire, RFP Role Function-Preventive, RFR Role Function-Restrictive, WPAI Work Productivity and Activity Impairment questionnaire, YI Youden index
Fig. 3
Fig. 3
Youden’s index for WPAI domain scores improvement at Month 3 for selected anchors (CM). WPAI scores are presented as % unit. CM chronic migraine, MHD monthly migraine headache days, MSQ Migraine-Specific Quality of Life questionnaire, RFP role function-preventive, RFR role function-restrictive, WPAI Work Productivity and Activity Impairment questionnaire, YI Youden index
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