Evidence map›Paper›PMID 37016181›Full record

Trial reportJournal of patient-reported outcomes2023

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

Janet H Ford, Wenyu Ye, David W Ayer, Xiaojuan Mi, Swati Bhandari, Dawn C Buse, Richard B Lipton

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of patient-reported outcomes, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03559257 (A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.1field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03559257 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study

TypeinterventionalSponsorEli Lilly and CompanyRan2018 to 2019Enrolled463ConditionsMigraineArmsGalcanezumab, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Janet H FordEli Lilly and Company, 893 Delaware St, Indianapolis, IN, 46225, USA.
Wenyu YeEli Lilly and Company, 893 Delaware St, Indianapolis, IN, 46225, USA. ye_wendy_wenyu@lilly.com.
David W AyerEli Lilly and Company, 893 Delaware St, Indianapolis, IN, 46225, USA.
Xiaojuan MiTechData Services Company, King of Prussia, PA, USA.
Swati BhandariEli Lilly and Company, 893 Delaware St, Indianapolis, IN, 46225, USA.
Dawn C BuseDepartment of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA.
Richard B LiptonDepartment of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA.
Eli Lilly (United States) · USAlbert Einstein College of Medicine · USMontefiore Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo 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).

methodThe 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.

resultsOf 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.

conclusionIn 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 registrationNCT number of CONQUER study, NCT03559257.

Indexed as

Migraine DisordersWork PerformanceHumansQuality of LifeReproducibility of ResultsSurveys and QuestionnairesAbsenteeismChronic migraineEpisodic migraineMeaningful changeNon-work-related activity impairmentPatient-reported outcomePresenteeismValidationWork Productivity and Activity Impairment questionnaire (WPAI)Work productivity loss

Identifiers

PMID37016181
PMCPMC10073392
OpenAlexW4362550036

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.