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.
Planning and reporting of quality-of-life outcomes in cancer trials / S. Schandelmaier, K. Conen, E. von Elm, J.J. You, A. Blümle, Y. Tomonaga, A. Amstutz, M. Briel, B. Kasenda, R. Saccilotto, T. Bengough, J.J. Meerpohl, M. Stegert, K.K. Olu, K.A.O. Tikkinen, I. Neumann, A. Carrasco-Labra, M. Faulhaber, S.M. Mulla, D. Mertz, E.A. Akl, X. Sun, D. Bassler, J.W. Busse, I. Ferreira-González, F. Lamontagne, A. Nordmann, V. Gloy, H. Raatz, L. Moja, R. Rosenthal, S. Ebrahim, P.O. Vandvik, B.C. Johnston, M.A. Walter, B. Burnand, M. Schwenkglenks, L.G. Hemkens, H.C. Bucher, G.H. Guyatt. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 26:9(2015), pp. 1966-1973.
|Titolo:||Planning and reporting of quality-of-life outcomes in cancer trials|
|Parole Chiave:||Cohort studies; Ethics committees; Neoplasms; Publication bias; Quality of life; Randomized controlled trials as topic; Oncology; Hematology|
|Settore Scientifico Disciplinare:||Settore MED/01 - Statistica Medica|
Settore MED/06 - Oncologia Medica
Settore MED/42 - Igiene Generale e Applicata
|Data di pubblicazione:||2015|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1093/annonc/mdv283|
|Appare nelle tipologie:||01 - Articolo su periodico|