ArticleContemporary clinical trials communications2022
Comparing the effects of a patient-designed-and-informed participant information leaflet in comparison with a standard, researcher-designed information leaflet on recruitment, retention and understanding: A study-within-a-trial.
Article in Contemporary clinical trials communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 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
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2026Pooled it
- Can a Public and Patient Involvement (PPI) Informed Participant Information Leaflet (PIL) Improve Trial Recruitment, Retention, and Quality of Decision Making? Results of a Randomised Controlled Double-Blind Study Within a Trial (SWAT).Health expectations : an international journal of public participation in health care and health policy · 2025Trial
- Trial
- Understanding the small print: a 5-year review of readability in phase I trial information leaflets.Trials · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background and aim: The process of trial recruitment is vital, given its impact on resources, statistical power and the validity of findings. A participant information leaflet (PIL) is often the initial and primary source of information engaged by potential participants during recruitment. Research suggests that a variety of manipulations to a PIL can be made during its development to enhance understanding, readability and accessibility. In light of this, PIL-design led by Method: This SWAT used a double-blind, two-armed randomised design. The SWAT was conducted within a host trial of cognitive rehabilitation in multiple sclerosis. Results: A total of 234 people expressed interest in the trial, of which 94 were retained at 6-month follow up. Results revealed no effects on levels of consent and retention between the two PIL groups. Conclusions: These null effects provide interesting points of discussion and important implications for not only future research on PILs, but also for future research that involves recruitment to health-related interventions.
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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.