{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T22:11:00Z","timestamp":1784326260008,"version":"3.55.0"},"reference-count":32,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,1,22]],"date-time":"2021-01-22T00:00:00Z","timestamp":1611273600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the measurement properties of all three domains of the Migraine\u2010Specific Quality of Life questionnaire version 2.1 (MSQ v2.1) electronic patient\u2010reported outcome (ePRO) to assess the functional impact of migraine in patients with episodic or chronic migraine (CM); and identify meaningful within\u2010patient change thresholds for the Role Function\u2010Restrictive (RFR), Role Function\u2010Preventive (RFP), and Emotional Function (EF) domains.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data were drawn from three double\u2010blind, placebo\u2010controlled, and randomized Phase 3 clinical studies (episodic migraine [EM]: EVOLVE\u20101 and EVOLVE\u20102; CM: REGAIN). The psychometric properties of the MSQ v2.1 ePRO domains were demonstrated by evaluating reliability (internal consistency and test\u2013retest), construct validity (convergent and known groups), and responsiveness. Meaningful within\u2010patient change thresholds for domains were estimated using anchor\u2010based approaches, supplemented by empirical cumulative distribution function curves and probability density function plots to enable interpretation of meaningful change over 3\u00a0months. The Patient Global Impression of Severity (PGI\u2010S) and Patient Global Impression of Improvement served as anchors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 2,850 patients with either EM (EVOLVE\u20101: 851; EVOLVE\u20102: 909) or CM (REGAIN: 1,090) were included. The Cronbach's alpha estimates of internal consistency exceeded the recommended threshold of \u22650.70 for all domains from the three studies, indicating adequate internal consistency. Test\u2013retest reliability intraclass correlation coefficients were \u22650.80 for all domains across all three studies, demonstrating almost perfect agreement. Convergent validity was supported by moderate\u2010to\u2010strong correlation (\n                      <jats:italic>r<\/jats:italic>\n                      \u00a0\u2265\u00a00.30) between all domains of MSQ v2.1 ePRO and studied anchors (Migraine Disability Assessment Score and PGI\u2010S scores) across all three studies. Known group validity was established between all domains and subgroups of patients stratified by baseline PGI\u2010S scores and baseline number of monthly migraine headache days for all three studies. The 3\u2010month meaningful within\u2010patient change thresholds were the same for EM and CM for RFP: 20.00 and EF: 26.67; and for RFR: 25.71.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These findings demonstrate that all three domains of the MSQ v2.1 ePRO have sufficient reliability, validity, responsiveness, and appropriate interpretation standards. Our results suggest that MSQ v2.1 ePRO is a well\u2010defined and reliable patient\u2010reported outcome instrument that is suitable for use in clinical studies for evaluating the impact of migraine on patient functioning in episodic and CM.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14031","type":"journal-article","created":{"date-parts":[[2021,1,22]],"date-time":"2021-01-22T22:27:07Z","timestamp":1611354427000},"page":"511-526","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Psychometric validation and meaningful within\u2010patient change of the Migraine\u2010Specific Quality of Life questionnaire version 2.1 electronic patient\u2010reported outcome in patients with episodic and chronic migraine"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3580-117X","authenticated-orcid":false,"given":"Rebecca M.","family":"Speck","sequence":"first","affiliation":[{"name":"Patient\u2010Centred Research Evidera Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ren","family":"Yu","sequence":"additional","affiliation":[{"name":"Patient\u2010Centred Research Evidera Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7966-7737","authenticated-orcid":false,"given":"Janet H.","family":"Ford","sequence":"additional","affiliation":[{"name":"Global Patient Outcomes and Real World Evidence (GPORWE) Eli Lilly and Company Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7973-4370","authenticated-orcid":false,"given":"David W.","family":"Ayer","sequence":"additional","affiliation":[{"name":"Global Patient Outcomes and Real World Evidence (GPORWE) Eli Lilly and Company Indianapolis IN 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