ArticleThe British journal of psychiatry : the journal of mental science2016
Sense and readability: participant information sheets for research studies.
Article in The British journal of psychiatry : the journal of mental science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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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
22 citing papers in PubMed.
- Investigating if changing the wording of a study invitation letter increased recruitment in a project promoting tobacco cessation in a town with high smoking rates.Substance abuse treatment, prevention, and policy · 2026Trial
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- Analysis of compliance and language use in broad informed consent forms in international multicenter clinical trials after the implementation of the 2018 common rule.BMC medical ethics · 2026Article
- The undue burdens of clinical trial participation: implications for equity, diversity, and inclusion.Trials · 2026Article
- COVID-19 pandemic and the management of type-2 diabetes mellitus among women in Fiji: concerns and context specific interventions.Frontiers in clinical diabetes and healthcare · 2026Article
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- Evaluating the Management of chronic Pelvic girdle Pain following pregnancy (EMaPP): a randomised controlled feasibility trial.Pilot and feasibility studies · 2025Article
- Ethical Issues and Challenges Regarding the Use of Mental Health Questionnaires in Public Health Nutrition Research.Nutrients · 2025Review
- Jargon and Readability in Plain Language Summaries of Health Research: Cross-Sectional Observational Study.Journal of medical Internet research · 2025Observational
- Benefits and challenges: Qualitative exploration of women's experiences during the COVID-19 pandemic in Fiji.PloS one · 2025Article
- Article
- 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.Contemporary clinical trials communications · 2022Article
- 'Do I have the capacity to make capacity judgements?' Researcher reflections from a person-centred dementia support study.Dementia (London, England) · 2022Article
- Terms and conditions apply: Critical issues for readability and jargon in mental health depression apps.Internet interventions · 2021Article
- Applying real-time Delphi methods: development of a pain management survey in emergency nursing.BMC nursing · 2021Article
- Experiences of research ethics committee members and scientists of the research protocol review process in Uganda: a case study.International health · 2020Article
- Article
- How one small text change in a study document can impact recruitment rates and follow-up completions.Internet interventions · 2019Article
- Article
- SWATted away: the challenging experience of setting up a programme of SWATs in paediatric trials.Trials · 2019Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformed consent in research is partly achieved through the use of information sheets. There is a perception however that these information sheets are long and complex. The recommended reading level for patient information is grade 6, or 11-12 years old.
aimsTo investigate whether the readability of participant information sheets has changed over time, whether particular study characteristics are related to poorer readability and whether readability and other study characteristics are related to successful study recruitment. Method: We obtained 522 information sheets from the UK National Institute for Health Research Clinical Research Network: Mental Health portfolio database and study principal investigators. Readability was assessed with the Flesch reading index and the Grade level test.
resultsInformation sheets increased in length over the study period. The mean grade level across all information sheets was 9.8, or 15-16 years old. A high level of patient involvement was associated with more recruitment success and studies involving pharmaceutical or device interventions were the least successful. The complexity of information sheets had little bearing on successful recruitment.
conclusionsInformation sheets are far more complex than the recommended reading level of grade 6 for patient information. The disparity may be exacerbated by an increasing focus on legal content. Researchers would benefit from clear guidance from ethics committees on writing succinctly and accessibly and how to balance the competing legal issues with the ability of participants to understand what a study entails.
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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.