ArticleAnnals of oncology : official journal of the European Society for Medical Oncology2015
Planning and reporting of quality-of-life outcomes in cancer trials.
Article in Annals of oncology : official journal of the European Society for Medical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 30 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Cannabinoids to Improve Health-Related Quality of Life in Patients with Neurological or Oncological Disease: A Meta-Analysis.Cannabis and cannabinoid research · 2023Pooled it
- Knowledge translation concerns for the CONSORT-PRO extension reporting guidance: a review of reviews.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022Pooled it
- [Anticancer therapy for symptom relief? : A systematic review of clinical trials in oncology].Schmerz (Berlin, Germany) · 2018Pooled it
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- A scoping review: Understanding brain tumor patients' decisional needs and preferences.Neuro-oncology practice · 2025Review
- Systematic evaluation of patient-reported outcomes in clinical trials of digital health in cardiovascular diseases.NPJ digital medicine · 2025Article
- Improvements in the health-related quality-of-life benefit of cancer drugs approved in China, 2005-2020: an observational study.The Lancet regional health. Western Pacific · 2024Article
- Review
- Curcumin: A Novel Way to Improve Quality of Life for Colorectal Cancer Patients?International journal of molecular sciences · 2022Review
- Improving the patient-reported outcome sections of clinical trial protocols: a mixed methods evaluation of educational workshops.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022Article
- The Use of Telemedicine in Cancer Clinical Trials: Connect-Patient-to-Doctor Prospective Study.JMIR cancer · 2022Article
- Article
- Trends in patient-reported outcome use in early phase dose-finding oncology trials - an analysis of ClinicalTrials.gov.Cancer medicine · 2021Article
- International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: A qualitative study.Cancer medicine · 2021Article
- Article
- Review
- Use of Health Related Quality of Life in Clinical Trials for Severe Asthma: A Systematic Review.Journal of asthma and allergy · 2021Review
- Associations between safety, tolerability, and toxicity and the reporting of health-related quality of life in phase III randomized trials in common solid tumors.Cancer medicine · 2020Article
- Mediating effects of shoulder-arm exercise on the postoperative severity of symptoms and quality of life of women with breast cancer.BMC women's health · 2020Article
Corrections and comments
- Erratum issued
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformation 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.
designRetrospective 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.
resultsOf 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.
conclusionsAbout 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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.