International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium
AuthorCoens, C; Pe, M; Dueck, AC; Sloan, J; Basch, E; Calvert, M; Campbell, A; Cleeland, C; Cocks, K; Collette, L; ...
Source TitleThe Lancet Oncology
PublisherELSEVIER SCIENCE INC
University of Melbourne Author/sDevlin, Nancy
AffiliationMelbourne School of Population and Global Health
Document TypeJournal Article
CitationsCoens, C., Pe, M., Dueck, A. C., Sloan, J., Basch, E., Calvert, M., Campbell, A., Cleeland, C., Cocks, K., Collette, L., Devlin, N., Dorme, L., Flechtner, H. -H., Gotay, C., Griebsch, I., Groenvold, M., King, M., Kluetz, P. G., Koller, M. ,... Bottomley, A. (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), pp.E83-E96. https://doi.org/10.1016/S1470-2045(19)30790-9.
Access StatusAccess this item via the Open Access location
Open Access URLhttp://eprints.whiterose.ac.uk/161154/30/SISAQOL%20Initial%20Recommendations%20-%20TLO%20-%20merged%20comments_FINAL_v2.pdf
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.
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