Planning and reporting of quality-of-life outcomes in cancer trials.
- Schandelmaier S Basel Institute for Clinical Epidemiology and Biostatistics; Academy of Swiss Insurance Medicine.
- Conen K Department of Oncology, University Hospital of Basel, Basel.
- von Elm E Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.
- You JJ Department of Clinical Epidemiology and Biostatistics; Department of Medicine, McMaster University, Hamilton, Canada.
- Blümle A German Cochrane Centre, Medical Center-University of Freiburg, Freiburg, Germany.
- Tomonaga Y Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich.
- Amstutz A Basel Institute for Clinical Epidemiology and Biostatistics.
- Briel M Basel Institute for Clinical Epidemiology and Biostatistics; Department of Clinical Epidemiology and Biostatistics; Department of Clinical Research, University of Basel, Basel, Switzerland.
- Kasenda B Basel Institute for Clinical Epidemiology and Biostatistics; Department of Oncology, University Hospital of Basel, Basel; Department of Medical Oncology, Royal Marsden Hospital, London, UK. Electronic address: benjamin.kasenda@gmail.com.
- 2015-07-03
Published in:
- Annals of oncology : official journal of the European Society for Medical Oncology. - 2015
cohort studies
ethics committees
neoplasms
publication bias
quality of life
randomized controlled trials as topic
Cohort Studies
Humans
Neoplasms
Quality of Life
Randomized Controlled Trials as Topic
Research Design
Retrospective Studies
Surveys and Questionnaires
English
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.
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.
- Language
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- English
- Open access status
- bronze
- Identifiers
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- DOI 10.1093/annonc/mdv283
- PMID 26133966
- Persistent URL
- https://sonar.ch/global/documents/47699
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