Coens, Corneel and Pe, Madeline and Dueck, Amylou C. and Sloan, Jeff and Basch, Ethan and Calvert, Melanie and Campbell, Alicyn and Cleeland, Charles and Cocks, Kim and Collette, Laurence and Devlin, Nancy and Dorme, Lien and Flechtner, Hans-Henning and Gotay, Carolyn and Griebsch, Ingolf and Groenvold, Mogens and King, Madeleine and Kluetz, Paul G. and Koller, Michael and Malone, Daniel C. and Martinelli, Francesca and Mitchell, Sandra A. and Musoro, Jammbe Z. and O'Connor, Daniel and Oliver, Kathy and Piault-Louis, Elisabeth and Piccart, Martine and Quinten, Chantal and Reijneveld, Jaap C. and Schuermann, Christoph and Smith, Ashley Wilder and Soltys, Katherine M. and Taphoorn, Martin J. B. and Velikova, Galina and Bottomley, Andrew (2020) International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium. LANCET ONCOLOGY, 21 (2). E83-E96. ISSN 1470-2045, 1474-5488
Full text not available from this repository. (Request a copy)Abstract
Patient-reported outcomes (PROs), such as symptoms, function, and other health-related quality-of-life aspects, are increasingly evaluated in cancer randomised controlled trials (RCTs) to provide information about treatment risks, benefits, and tolerability. However, expert opinion and critical review of the literature showed no consensus on optimal methods of PRO analysis in cancer RCTs, hindering interpretation of results. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium was formed to establish PRO analysis recommendations. Four issues were prioritised: developing a taxonomy of research objectives that can be matched with appropriate statistical methods, identifying appropriate statistical methods for PRO analysis, standardising statistical terminology related to missing data, and determining appropriate ways to manage missing data. This Policy Review presents recommendations for PRO analysis developed through critical literature reviews and a structured collaborative process with diverse international stakeholders, which provides a foundation for endorsement; ongoing developments of these recommendations are also discussed.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | MISSING DATA; CLINICAL-TRIALS; STATISTICAL-ANALYSIS; INCLUSION; EXTENSION; MODEL; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien |
| Depositing User: | Petra Gürster |
| Date Deposited: | 25 Mar 2021 06:52 |
| Last Modified: | 25 Mar 2021 06:52 |
| URI: | https://pred.uni-regensburg.de/id/eprint/45262 |
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