Trial reportTrials2011
Accrual and drop out in a primary prevention randomised controlled trial: qualitative study.
Trial report in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis 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
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis.The Cochrane database of systematic reviews · 2020Pooled it
- Trial
- "Until the trial is complete you can't really say whether it helped you or not, can you?": exploring cancer patients' perceptions of taking part in a trial of acupressure wristbands.BMC complementary and alternative medicine · 2013Trial
- Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network's PeRSEVERE project.Clinical trials (London, England) · 2025Article
- Participation in and withdrawal from cancer clinical trials: A survey of clinical research coordinators.Asia-Pacific journal of oncology nursing · 2022Article
- Leveraging external data in the design and analysis of clinical trials in neuro-oncology.The Lancet. Oncology · 2021Review
- Older participant perspectives on permanent study drug discontinuation in an ongoing primary prevention trial of statins.European journal of clinical pharmacology · 2021Article
- Does prospective acceptability of an intervention influence refusal to participate in a randomised controlled trial? An interview study.Contemporary clinical trials communications · 2021Article
- The effects of releasing early results from ongoing clinical trials.Nature communications · 2021Article
- Article
- Design and Evaluation of an External Control Arm Using Prior Clinical Trials and Real-World Data.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019Article
- Exploring non-retention in clinical trials: a meta-ethnographic synthesis of studies reporting participant reasons for drop out.BMJ open · 2019Article
- Article
- Systematic Techniques to Enhance rEtention in Randomised controlled trials: the STEER study protocol.Trials · 2018Article
- Reducing attrition within clinical trials: The communication of retention and withdrawal within patient information leaflets.PloS one · 2018Article
- Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework.BMC health services research · 2017Article
- Understanding motivations to participate in an observational research study: Why do patients enroll?Social work in health care · 2016Article
- Experiences of recruiting to a pilot trial of Cardiac Rehabilitation In patients with Bowel cancer (CRIB) with an embedded process evaluation: lessons learned to improve recruitment.Pilot and feasibility studies · 2015Article
- Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRecruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community.
methodsSemi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA) trial (N = 11), and AAA trial participants who had stopped taking the trial medication (N = 11). A focus group with further participants who had stopped taking the trial medication (N = 6). (Total participants N = 28).
resultsExplanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating.Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind.
conclusionsThese results indicate that when planning trials (especially in preventive medicine) particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation.
trial registrationISRCTN66587262.
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Registered trials
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.