ArticleBMC medical research methodology2010
Involving users in the design of a randomised controlled trial of an intervention to promote early presentation in breast cancer: qualitative study.
Article in BMC medical research methodology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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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
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Interventions for raising breast cancer awareness in women.The Cochrane database of systematic reviews · 2017Pooled it
- Co-designing primary and secondary outcome measures for an international phase 3 trial of surgical de-escalation in vulvar cancer through a consumer workshop.Research involvement and engagement · 2026Article
- Stakeholder engagement as a valuable tool to improve the relevance of research regarding framework development.npj veterinary sciences · 2026Article
- Beyond Participation: Evaluating the Role of Patients in Designing Oncology Clinical Trials.Current oncology (Toronto, Ont.) · 2023Review
- Patient and public involvement in cancer research: A scoping review.Cancer medicine · 2023Article
- Article
- Changing Author Guidelines to Include Patient and Public Involvement.International journal of therapeutic massage & bodywork · 2019Article
- A co-produced method to involve service users in research: the SUCCESS model.BMC medical research methodology · 2019Article
- Applying a community-based participatory research framework to patient and family engagement in the development of patient-centered outcomes research and practice.Translational behavioral medicine · 2018Review
- Consumer involvement in cancer research: example from a Cancer Network.Health expectations : an international journal of public participation in health care and health policy · 2015Article
- Active patient participation in the development of an online intervention.JMIR research protocols · 2014Article
- Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation.BMJ open · 2014Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
backgroundThe purpose of this study was to explore women's views of the design of a large pragmatic cost-effectiveness randomised controlled trial of the policy of offering a health professional-delivered intervention to promote early presentation with breast symptoms in older women and thereby improve survival, with a view to informing protocol development. The trial will recruit over 100,000 healthy women aged 67+, and outcome data will be collected on those who develop breast cancer. The scale of the trial and the need for long-term follow-up presented a number of design challenges in relation to obtaining consent, ascertaining and contacting participants who developed breast cancer, and collecting outcome data.
methodsQualitative study involving 69 women participating in 7 focus groups and 17 in-depth interviews. 15 women had a previous diagnosis of breast cancer and 54 did not.
resultsThe women held strong views and had a good understanding of the rationale of the design of clinical trials. The women recognised that in a very large trial with long-term follow-up it was necessary to incorporate design features to make the trial feasible and efficient. Most strikingly, they supported the idea of opt-out consent and identifying women with breast cancer using routine datasets.
conclusionsThis model of user involvement engaged women well with the design challenges of the trial and led to improvements to the protocol. The study strengthens the case for user involvement, in particular through focus groups and in-depth interviews, in the design of trials.
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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.