ArticlePloS one2022
Information about dissemination of trial results in patient information leaflets for clinicals trials in the UK and Ireland: The what and the when.
Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 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
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Current global practice and implications for future research on disseminating health research results to study participants: A systematic review.PLoS medicine · 2025Pooled it
- Developing evidence-based guidelines for describing potential benefits and harms within patient information leaflets/sheets (PILs) that inform and do not cause harm (PrinciPILs).Health technology assessment (Winchester, England) · 2025Article
- Adequate information about clinical trial results must be given to participants.Nature medicine · 2024Article
- Framework of the strengths and challenges of clinically integrated trials: An expert panel report.American heart journal · 2024Review
- When describing harms and benefits to potential trial participants, participant information leaflets are inadequate.Trials · 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
3 authors.
Funding
Abstract
introductionComplete and understandable information is vital for informed consent and this includes how and when potential participants can expect to receive trial results. Informing participants during informed consent about the sharing of trial results is important for addressing participants' needs, ensuring adherence to regulatory guidance, and in fulfilling a moral obligation.
methodsPatient Information Leaflets (PILs) were collated from across the UK and Ireland. Trial characteristics and data on disseminating trial results was extracted. Analysis included descriptive statistics and a directed content analysis approach. The content analysis framework was informed by regulatory guidance on PIL content and existing research on dissemination of trial results. Results were analysed using descriptive statistics and presented as a narrative summary as appropriate.
results238 PILs from 178 trials were analysed. Of the 238 PILs, 74% (n = 176) provided information on sharing results with participants, 70% (n = 123) of which described passive methods of disseminating results that require active engagement from the trial participants, i.e., effort required by the participant to seek the results. The majority (90%) of PILs included more than one proposed mode of dissemination that largely targeted healthcare professionals rather than participants. Only 8% of PILs specified a time period for when results could be expected, 47% did not specify a time period (e.g. at end of trial), and 45% included no information on when trial results would be available.
conclusionThis study found that majority of the PILs included did include some information about dissemination of trial results. However, modes of dissemination tended to target researchers and clinicians rather than participants and information on when results would be available was often lacking. The findings highlight the need for further research that includes stakeholder input to identify what information on results summaries participants need at the point of making a decision about trial participation.
Indexed as
Identifiers
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.