Trial reportTrials2017
An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.
Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 7 of them syntheses that pooled it.
What it found
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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.
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Who cites it
27 citing papers in PubMed, 7 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2026Pooled it
- Pooled it
- Do recruitment SWAT interventions have an impact on participant retention in randomised controlled trials? A systematic review.Clinical trials (London, England) · 2024Pooled it
- Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.BMC medicine · 2021Pooled it
- Strategies to improve retention in randomised trials.The Cochrane database of systematic reviews · 2021Pooled it
- Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2018Pooled it
- Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2018Pooled it
- Trial
- Trial
- Optimised patient information materials and recruitment to a study of behavioural activation in older adults: an embedded study within a trial.F1000Research · 2020Trial
- The OMACS-PIL study: a randomised controlled trial within the OMACS observational study.Trials · 2019Trial
- Effectiveness of different recruitment strategies in an RCT of a surgical device: experience from the Endobarrier trial.BMJ open · 2019Trial
- Trial
- Trial
- Article
- Patient engagement and shared decision-making in trial recruitment intervention studies: a systematic review.Research involvement and engagement · 2025Review
- Describing the content of trial recruitment interventions using the TIDieR reporting checklist: a systematic methodology review.BMC medical research methodology · 2024Article
- Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme.Health technology assessment (Winchester, England) · 2024Article
- Behavioral Economic Strategies to Improve Enrollment Rates in Clinical Research: Embedded Recruitment Pilot Trial.JMIR formative research · 2023Article
- Challenges and solutions to the implementation of studies within a trial: The experiences of the PROMETHEUS programme.Research methods in medicine & health sciences · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 9 institutions in 3 countries.
Funding
Abstract
backgroundRandomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial.
methodsA three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial.
resultsSix thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65)).
conclusionsThis embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study.
trial registrationInternational Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.
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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.