Trial reportPloS one2012
A booklet on participants' rights to improve consent for clinical research: a randomized trial.
Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 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
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.
- Towards a more patient-centered clinical trial process: A systematic review of interventions incorporating health literacy best practices.Contemporary clinical trials · 2022Pooled it
- The Readability Study: A Randomised Trial of Health Information Written at Different Grade Reading Levels.Journal of general internal medicine · 2025Trial
- Permission form synopses to improve parents' understanding of research: a randomized trial.Journal of perinatology : official journal of the California Perinatal Association · 2017Trial
- Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.BMC medical ethics · 2016Trial
- Improved informed consent documents for biomedical research do not increase patients' understanding but reduce enrolment: a study in real settings.British journal of clinical pharmacology · 2015Trial
- Review
- Comprehension of written texts for the assessment of clinical competence and decision making in people with mild to moderate Alzheimer disease.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2020Article
- Facilitating Informed Permission/Assent/Consent in Pediatric Clinical Trials.Paediatric drugs · 2019Article
- Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China.PloS one · 2016Article
- A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.Clinical trials (London, England) · 2015Article
- Addressing risks to advance mental health research.JAMA psychiatry · 2013Article
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 at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveInformation on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent.
methods21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire.
resultsInformation related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68).
conclusionsA booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials.
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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.