{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T08:21:35Z","timestamp":1782462095503,"version":"3.54.5"},"reference-count":21,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,2,9]],"date-time":"2023-02-09T00:00:00Z","timestamp":1675900800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000071","name":"National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["U01NS077108"],"award-info":[{"award-number":["U01NS077108"]}],"id":[{"id":"10.13039\/100000071","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["T32DK063929"],"award-info":[{"award-number":["T32DK063929"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000065","name":"National Institute of Neurological Disorders and Stroke","doi-asserted-by":"publisher","award":["U01NSS076788"],"award-info":[{"award-number":["U01NSS076788"]}],"id":[{"id":"10.13039\/100000065","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To examine group differences in self\u2010reported migraine days among youth who completed the Childhood and Adolescent Migraine Prevention (CHAMP) trial prior to its closure and explore the relationship between self\u2010reported and \u201cnosology\u2010derived\u201d (i.e., International Classification of Headache Disorders, 3rd edition [ICHD\u20103]) migraine days.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The CHAMP trial compared amitriptyline and topiramate to placebo for migraine prevention in youth and proposed to analyze change in migraine days as a secondary outcome. There is considerable variability in the field regarding what constitutes a \u201cmigraine day,\u201d how this is determined and reported in trials, and how consistent these measures are with diagnostic nosology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      CHAMP trial completers (\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u00a0175) were randomized to receive amitriptyline (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a077), topiramate (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a063), or placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a035). Participants maintained daily headache diaries where they reported each day with headache and if they considered that headache to be a migraine. For each headache day, participants completed a symptom record and reported about symptoms such as pain location(s) and presence of nausea\/vomiting or photophobia and phonophobia. We examined group differences in self\u2010reported migraine days at trial completion (summed from trial weeks 20\u201324) compared to baseline. We also used an algorithm to determine whether participants\u2019 symptom reports met ICHD\u20103 criteria for migraine without aura, and examined the association between self\u2010reported and \u201cnosology\u2010derived\u201d migraine days.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Results showed no significant differences between groups in self\u2010reported migraine days over the course of the trial. Self\u2010reported and \u201cnosology\u2010derived\u201d migraine days during the baseline and treatment phases were strongly associated (\n                      <jats:italic>r<\/jats:italic>\n                      's\u00a0\n                      <jats:italic>=<\/jats:italic>\n                      \u00a00.73 and 0.83, respectively;\n                      <jats:italic>p<\/jats:italic>\n                      's\u2009&lt;\u20090.001).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Regardless of treatment, CHAMP trial completers showed clinically important reductions in self\u2010reported migraine days over the course of the trial (about 3.8\u2009days less). The strong association between self\u2010reported and \u201cnosology\u2010derived\u201d migraine days suggests youth with migraine can recognize a day with migraine and reliably report their headache features and symptoms. Greater rigor and transparency in the calculation and reporting of migraine days in trials is needed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14474","type":"journal-article","created":{"date-parts":[[2023,2,9]],"date-time":"2023-02-09T08:04:21Z","timestamp":1675929861000},"page":"805-812","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Impact of preventive pill\u2010based treatment on migraine days: A secondary outcome study of the Childhood and Adolescent Migraine Prevention (\n                    <scp>CHAMP<\/scp>\n                    ) trial and a comparison of self\u2010report to nosology\u2010derived assessments"],"prefix":"10.1111","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1532-7044","authenticated-orcid":false,"given":"Robert C.","family":"Gibler","sequence":"first","affiliation":[{"name":"Behavioral Medicine and Clinical Psychology Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"},{"name":"Headache Center Cincinnati Children's Hospital Medical Center  Ohio Cincinnati USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James L.","family":"Peugh","sequence":"additional","affiliation":[{"name":"Behavioral Medicine and Clinical Psychology Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"},{"name":"Department of Pediatrics Cincinnati Children's Hospital Medical Center  Ohio Cincinnati USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher S.","family":"Coffey","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of Iowa  Iowa Iowa City USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leigh Ann","family":"Chamberlin","sequence":"additional","affiliation":[{"name":"Behavioral Medicine and Clinical Psychology Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dixie","family":"Ecklund","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of Iowa  Iowa Iowa City USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Klingner","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of Iowa  Iowa Iowa City USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jon","family":"Yankey","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of Iowa  Iowa Iowa City USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie L.","family":"Korbee","sequence":"additional","affiliation":[{"name":"Academic Regulatory &amp; Monitoring Services, LLC  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marielle","family":"Kabbouche","sequence":"additional","affiliation":[{"name":"Division of Neurology Cincinnati Children's Hospital Medical Center  Ohio Cincinnati USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanne","family":"Kacperski","sequence":"additional","affiliation":[{"name":"Headache Center Cincinnati Children's Hospital Medical Center  Ohio Cincinnati USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda L.","family":"Porter","sequence":"additional","affiliation":[{"name":"National Institute of Neurological Disorders and Stroke, National Institutes of Health  Bethesda Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brooke L.","family":"Reidy","sequence":"additional","affiliation":[{"name":"Behavioral Medicine and Clinical Psychology Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"},{"name":"Headache Center Cincinnati Children's Hospital Medical Center  Ohio Cincinnati USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1598-7536","authenticated-orcid":false,"given":"Andrew D.","family":"Hershey","sequence":"additional","affiliation":[{"name":"Headache Center Cincinnati Children's Hospital Medical Center  Ohio Cincinnati USA"},{"name":"Division of Neurology Cincinnati Children's Hospital Medical Center  Ohio Cincinnati USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5348-9650","authenticated-orcid":false,"given":"Scott W.","family":"Powers","sequence":"additional","affiliation":[{"name":"Behavioral Medicine and Clinical Psychology Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"},{"name":"Headache Center Cincinnati Children's Hospital Medical Center  Ohio Cincinnati USA"},{"name":"Department of Pediatrics Cincinnati Children's Hospital Medical Center  Ohio Cincinnati 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