{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T19:21:22Z","timestamp":1778181682164,"version":"3.51.4"},"reference-count":25,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2018,8,24]],"date-time":"2018-08-24T00:00:00Z","timestamp":1535068800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Fonds Cancer Belgium"},{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2018,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and Results<\/jats:title>\n                    <jats:p>Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues. Data from systematic reviews of the current state of published research in patient-reported outcomes in cancer RCTs indicated a lack of clear reporting of research hypothesis and analytic strategies, and inconsistency in definitions of terms, including \u201cmissing data,\u201d\u201chealth-related quality of life,\u201d and \u201cpatient-reported outcome.\u201d Based on the meeting proceedings, the Consortium will focus on three key priorities in the coming year: developing a taxonomy of research objectives, identifying appropriate statistical methods to analyze patient-reported outcome data, and determining best practices to evaluate and deal with missing data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators, patients, clinicians, and academics.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1740774518795637","type":"journal-article","created":{"date-parts":[[2018,8,24]],"date-time":"2018-08-24T09:14:42Z","timestamp":1535102082000},"page":"624-630","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":45,"title":["Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials"],"prefix":"10.1177","volume":"15","author":[{"given":"Andrew","family":"Bottomley","sequence":"first","affiliation":[{"name":"Quality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium"}]},{"given":"Madeline","family":"Pe","sequence":"additional","affiliation":[{"name":"Quality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium"}]},{"given":"Jeff","family":"Sloan","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA"}]},{"given":"Ethan","family":"Basch","sequence":"additional","affiliation":[{"name":"Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA"}]},{"given":"Franck","family":"Bonnetain","sequence":"additional","affiliation":[{"name":"Methodology and Quality of Life Unit in Cancer, INSERM U1098, University Hospital of Besan\u00e7on, Besan\u00e7on, France"}]},{"given":"Melanie","family":"Calvert","sequence":"additional","affiliation":[{"name":"Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK"}]},{"given":"Alicyn","family":"Campbell","sequence":"additional","affiliation":[{"name":"Genentech, San Francisco, CA, USA"}]},{"given":"Charles","family":"Cleeland","sequence":"additional","affiliation":[{"name":"Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA"}]},{"given":"Kim","family":"Cocks","sequence":"additional","affiliation":[{"name":"Adelphi Values, Bollington, UK"}]},{"given":"Laurence","family":"Collette","sequence":"additional","affiliation":[{"name":"Quality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium"}]},{"given":"Amylou C","family":"Dueck","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA"}]},{"given":"Nancy","family":"Devlin","sequence":"additional","affiliation":[{"name":"Office of Health Economics, London, UK"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6978-1587","authenticated-orcid":false,"given":"Hans-Henning","family":"Flechtner","sequence":"additional","affiliation":[{"name":"Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany"}]},{"given":"Carolyn","family":"Gotay","sequence":"additional","affiliation":[{"name":"School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada"}]},{"given":"Eva","family":"Greimel","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Medical University Graz, Graz, Austria"}]},{"given":"Ingolf","family":"Griebsch","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim, Frankfurt, Germany"}]},{"given":"Mogens","family":"Groenvold","sequence":"additional","affiliation":[{"name":"Department of Public Health, University of Copenhagen and Bispebjerg Hospital, Copenhagen, Denmark"}]},{"given":"Jean-Francois","family":"Hamel","sequence":"additional","affiliation":[{"name":"Methodology and Biostatistics Department, University Hospital of Angers UNAM, Angers, France"}]},{"given":"Madeleine","family":"King","sequence":"additional","affiliation":[{"name":"School of Psychology and Sydney Medical School, University of Sydney, Sydney, NSW, Australia"}]},{"given":"Paul G","family":"Kluetz","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration, Silver Spring, MD, USA"}]},{"given":"Michael","family":"Koller","sequence":"additional","affiliation":[{"name":"Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany"}]},{"given":"Daniel C","family":"Malone","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of Arizona, Tucson, AZ, USA"}]},{"given":"Francesca","family":"Martinelli","sequence":"additional","affiliation":[{"name":"Quality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium"}]},{"given":"Sandra A","family":"Mitchell","sequence":"additional","affiliation":[{"name":"Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA"}]},{"given":"Carol M","family":"Moinpour","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Research Center, Seattle, WA, USA"}]},{"given":"Jammbe Z","family":"Musoro","sequence":"additional","affiliation":[{"name":"Quality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium"}]},{"given":"Daniel","family":"O\u2019Connor","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare Products Regulatory Agency, London, UK"}]},{"given":"Kathy","family":"Oliver","sequence":"additional","affiliation":[{"name":"International Brain Tumour Alliance, Surrey, UK"}]},{"given":"Elisabeth","family":"Piault-Louis","sequence":"additional","affiliation":[{"name":"Genentech, San Francisco, CA, USA"}]},{"given":"Martine","family":"Piccart","sequence":"additional","affiliation":[{"name":"Internal 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