ArticleBMJ open2014
Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation.
Article in BMJ open, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07094269 (Protocol for a Superiority Randomized Controlled Trial of a Group-Based Fatigue Management Program Versus Standard Information to Improve Self-Efficacy in Energy Conservation in Parkinson's Disease), which is not on this map. Cited by 49 papers, 2 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.
Protocol for a Superiority Randomized Controlled Trial of a Group-Based Fatigue Management Program Versus Standard Information to Improve Self-Efficacy in Energy Conservation in Parkinson's Disease
Who cites it
49 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Patient and public involvement and engagement (PPIE) in Otolaryngology research: a systematic review of randomised controlled trials.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025Pooled it
- A Systematic Review of Patient and Public Involvement (PPI) in Bariatric Research Trials: The Need for More Work.Obesity surgery · 2022Pooled it
- Patient and public involvement in a randomized study: a qualitative study of participants' experiences in a Mediterranean Diet trial.Journal of public health (Oxford, England) · 2025Trial
- A report on parent involvement in planning a randomised controlled trial in neonatology and lactation - insights for current and future research.International breastfeeding journal · 2022Trial
- Trial
- Trial
- Trial
- Trial
- 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
- Patient and public involvement in pragmatic trials with older adults: a multi-methods study of researchers' experiences.BMC geriatrics · 2026Article
- Article
- Public and Patient Involvement and Engagement in Clinical Trials: A Multi-Perspective Mixed-Methods Evaluation of the ROWTATE Programme.Health expectations : an international journal of public participation in health care and health policy · 2026Article
- Patient and Public Involvement in Paediatric Pragmatic Randomized Controlled Trials: A Mixed Methods Study.Children (Basel, Switzerland) · 2025Article
- Rigor and equity in intervention study design in pediatric psychology: a focus on comparator conditions from diabetes research.Journal of pediatric psychology · 2025Review
- Review
- Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration.BMJ (Clinical research ed.) · 2025Article
- Establishment of a patient and public involvement and engagement group to support clinical trials in Pakistan: Initial lessons learned.Research involvement and engagement · 2024Article
- Article
- Asking those who know their needs best: A framework for active engagement and involvement of childhood cancer survivors and parents in the process of psychosocial research-A workshop report.Cancer reports (Hoboken, N.J.) · 2024Article
- Guidance to inform research recruitment processes for studies involving critically ill patients.Journal of the Intensive Care Society · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundRandomised controlled trials (RCTs) are considered particularly likely to benefit from patient and public involvement (PPI). Decisions made by professional researchers at the outset may go on to have a significant impact on the potential for PPI contributions.
objectiveTo increase knowledge of PPI within the early development of RCTs by systematically describing the reported level, nature and acceptability of proposed PPI to the funders.
methodsDocumentation from the outline application process for all RCTs that received funding from the Health Technology Assessment (HTA) Programme 2006-2010 was requested. For each application, data were extracted on trial characteristics, references to PPI in the development of the outline application and funding Board feedback, and plans for PPI in the full application and after the trial was funded.
results110 applications were eligible with outline applications available for 90 (82%). The cohort covered a wide range of interventions and conditions. 54% (49/90) provided some information about PPI. 26 (28.9%) indicated PPI within the development of the outline application itself; 32 (35.6%) planned involvement in the full application and 43 (48%) once the trial was funded. Recruitment at diagnosis and surgical interventions were less likely to describe PPI. Blinded trials and trials in which participants may receive placebo only, more frequently described PPI activity. The HTA commissioning Board feedback rarely referred to PPI.
conclusionsIncorporation of PPI within the development of the outline application or specification of plans for future involvement was low. Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research. Comments on PPI by reviewers should be directional rather than state that an increase is required. Challenges facing applicants in initiating PPI prior to funding need to be addressed.
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What OpenQuestion holds
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.