Planning and Reporting of Quality of Life Outcomes in Cancer Trials
A partir de données portant sur 173 essais cliniques en oncologie, cette étude analyse la fréquence et la qualité des informations relatives à la qualité de vie dans les protocoles soumis à l'autorisation des comités d'éthique et dans les publications associées
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 (vs. non-industry), sample size, and multi centre (vs. 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 quality of life data in associated publications. Highly relevant information for decision-making is often unavailable to patients, oncologists, and health-policy makers.