Bottomley, Andrew and Pe, Madeline and Sloan, Jeff and Basch, Ethan and Bonnetain, Franck and Calvert, Melanie and Campbell, Alicyn and Cleeland, Charles and Cocks, Kim and Collette, Laurence and Dueck, Amylou C. and Devlin, Nancy and Flechtner, Hans-Henning and Gotay, Carolyn and Greimel, Eva and Griebsch, Ingolf and Groenvold, Mogens and Hamel, Jean-Francois and King, Madeleine and Kluetz, Paul G. and Koller, Michael and Malone, Daniel C. and Martinelli, Francesca and Mitchell, Sandra A. and Moinpour, Carol M. and Musoro, Jammbe Z. and O'Connor, Daniel and Oliver, Kathy and Piault-Louis, Elisabeth and Piccart, Martine and Pimentel, Francisco L. and Quinten, Chantal and Reijneveld, Jaap C. and Schuermann, Christoph and Smith, Ashley Wilder and Soltys, Katherine M. and Sridhara, Rajeshwari and Taphoorn, Martin J. B. and Velikova, Galina and Coens, Corneel (2018) Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials. CLINICAL TRIALS, 15 (6). pp. 624-630. ISSN 1740-7745, 1740-7753
Full text not available from this repository. (Request a copy)Abstract
Background 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. Methods and Results 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 "missing data,""health-related quality of life," and "patient-reported outcome." 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. Conclusion The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators, patients, clinicians, and academics.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DECISION-MAKING; PATIENT; CARE; Guidelines; standards; cancer clinical trials; health-related quality of life; patient-reported outcomes |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 09 Oct 2019 06:03 |
| Last Modified: | 09 Oct 2019 06:03 |
| URI: | https://pred.uni-regensburg.de/id/eprint/13491 |
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