Schandelmaier, S. and Conen, K. and von Elm, E. and You, J. J. and Blümle, A. and Tomonaga, Y. and Saccilotto, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel and Switzerland., and Amstutz, A. and Bengough, T. and Meerpohl, J. J. and Stegert, M. and Olu, K. K. and Tikkinen, K. A. O. and Neumann, I. and Carrasco-Labra, A. and Faulhaber, M. and Mulla, S. M. and Mertz, D. and Akl, E. A. and Sun, X. and Bassler, D. and Busse, J. W. and Ferreira-González, I. and Lamontagne, F. and Nordmann, A. and Gloy, V. and Raatz, H. and Moja, L. and Rosenthal, R. and Ebrahim, S. and Vandvik, P. O. and Johnston, B. C. and Walter, M. A. and Burnand, B. and Schwenkglenks, M. and Hemkens, L. G. and Bucher, H. C. and Guyatt, G. H. and Briel, M. and Kasenda, B. and Disco study group, .
(2015)
Planning and reporting of quality-of-life outcomes in cancer trials.
Annals of Oncology, 26 (9).
pp. 1966-1973.
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Abstract
Information about the impact of cancer treatments on patients' quality of life (QoL) is of paramount importance to patients and treating oncologists. Cancer trials that do not specify QoL as an outcome or fail to report collected QoL data, omit crucial information for decision making. To estimate the magnitude of these problems, we investigated how frequently QoL outcomes were specified in protocols of cancer trials and subsequently reported.; Retrospective cohort study of RCT protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We compared protocols to corresponding publications, which were identified through literature searches and investigator surveys.; Of the 173 cancer trials, 90 (52%) specified QoL outcomes in their protocol, 2 (1%) as primary and 88 (51%) as secondary outcome. Of the 173 trials, 35 (20%) reported QoL outcomes in a corresponding publication (4 modified from the protocol), 18 (10%) were published but failed to report QoL outcomes in the primary or a secondary publication, and 37 (21%) were not published at all. Of the 83 (48%) trials that did not specify QoL outcomes in their protocol, none subsequently reported QoL outcomes. Failure to report pre-specified QoL outcomes was not associated with industry sponsorship (versus non-industry), sample size, and multicentre (versus single centre) status but possibly with trial discontinuation.; About half of cancer trials specified QoL outcomes in their protocols. However, only 20% reported any QoL data in associated publications. Highly relevant information for decision making is often unavailable to patients, oncologists, and health policymakers.
| Faculties and Departments: | 03 Faculty of Medicine > Departement Klinische Forschung > Clinical Epidemiology and Biostatistics CEB > Klinische Epidemiologie (Bucher H) |
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| UniBasel Contributors: | Kasenda, Benjamin |
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| Item Type: | Article, refereed |
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| Article Subtype: | Research Article |
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| Publisher: | Oxford University Press |
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| ISSN: | 0923-7534 |
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| e-ISSN: | 1569-8041 |
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| Note: | Publication type according to Uni Basel Research Database: Journal article |
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| Language: | English |
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| Identification Number: | |
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| edoc DOI: | |
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| Last Modified: | 13 Mar 2018 17:17 |
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| Deposited On: | 09 Oct 2017 06:43 |
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