Planning and reporting of quality-of-life outcomes in cancer trials.

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It was possible to publish this article open access thanks to a Swiss National Licence with the publisher.
Serval ID
serval:BIB_A0365E50800D
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Planning and reporting of quality-of-life outcomes in cancer trials.
Journal
Annals of Oncology : Official Journal of the European Society For Medical Oncology / Esmo
Author(s)
Schandelmaier S., Conen K., von Elm E., You J.J., Blümle A., Tomonaga Y., Saccilotto A., Amstutz A., Bengough T., Meerpohl J.J., Stegert M., Olu K.K., Tikkinen K.A., Neumann I., Carrasco-Labra A., Faulhaber M., Mulla S.M., Mertz D., Akl E.A., Sun X., Bassler D., Busse J.W., Ferreira-González I., Lamontagne F., Nordmann A., Gloy V., Raatz H., Moja L., Rosenthal R., Ebrahim S., Vandvik P.O., Johnston B.C., Walter M.A., Burnand B., Schwenkglenks M., Hemkens L.G., Bucher H.C., Guyatt G.H., Briel M., Kasenda B.
Working group(s)
DISCO study group
ISSN
1569-8041 (Electronic)
ISSN-L
0923-7534
Publication state
Published
Issued date
2015
Peer-reviewed
Oui
Volume
26
Number
9
Pages
1966-1973
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
BACKGROUND: 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.
DESIGN: 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.
RESULTS: 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.
CONCLUSIONS: 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.
Keywords
Cohort Studies, Humans, Neoplasms/therapy, Quality of Life, Randomized Controlled Trials as Topic/methods, Research Design, Retrospective Studies, Surveys and Questionnaires
Pubmed
Web of science
Open Access
Yes
Create date
13/10/2015 19:07
Last modification date
25/09/2019 7:10
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