SynthesisTrials2023
Reporting of PPI and the MCID in phase III/IV randomised controlled trials-a systematic review.
Synthesis in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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
8 citing papers in PubMed.
- 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
- Trends in patient and public involvement in health research 2000-2024.Research involvement and engagement · 2026Review
- Giving credit where credit's due - recognition of patient partners in health research.Research involvement and engagement · 2026Article
- Cutting through the p-value: evaluating clinical relevance in surgical literature analyzing the approaches for inguinal hernia repair.Surgical endoscopy · 2025Article
- Disparity between statistical significance and clinical importance in published randomised controlled trials: a methodological study.BMJ open · 2025Article
- Beyond statistical significance: Embracing minimal clinically important difference for better patient care.World journal of methodology · 2025Review
- Power to Detect What? Considerations for Planning and Evaluating Sample Size.Personality and social psychology review : an official journal of the Society for Personality and Social Psychology, Inc · 2024Review
- Patient and Public Involvement and Engagement in the Development of a Platform Clinical Trial for Parkinson's Disease: An Evaluation Protocol.Journal of Parkinson's disease · 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
6 authors.
Funding
Abstract
backgroundPatient and public involvement (PPI) in clinical trial design contributes to ensuring the research objectives and outcome measures are relevant to patients. The minimal clinically important difference (MCID) in the primary outcome influences trial design and feasibility and should be predicated on PPI. We aimed to determine current practice of reporting PPI and the MCID in phase III/IV randomised controlled trials (RCTs).
methodsFollowing a search of Medline, Embase, and the Cochrane Central Register of Controlled Trials, we included primary publications of phase III/IV RCTs, in English, inclusive of any medical specialty or type of intervention, that reported a health-related outcome. We excluded protocols and secondary publications of RCTs. We extracted RCT characteristics, the use of PPI, and use of the MCID.
resultsBetween 1 July 2019 and 13 January 2020, 123 phase III/IV RCTs matched our eligibility criteria. Ninety percent evaluated a medical rather than surgical intervention. Oncology accounted for 21% of all included RCTs. Only 2.4% (n = 3) and 1.6% (n = 2) RCTs described PPI and the MCID respectively.
conclusionsPPI and the MCID are poorly reported, so it is uncertain how these contributed to trial design. Improvement in the reporting of these items would increase confidence that results are relevant and clinically significant to patients, contributing to improving the overall trial design.
trial registrationNot registered.
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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.