Trial reportBritish journal of clinical pharmacology2015
Improved informed consent documents for biomedical research do not increase patients' understanding but reduce enrolment: a study in real settings.
Trial report in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2026Pooled it
- Pooled it
- Measuring and evaluating participant understanding of consent processes in clinical trials: a systematic review.Trials · 2026Pooled it
- Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?BMC medical ethics · 2020Trial
- Patient engagement and shared decision-making in trial recruitment intervention studies: a systematic review.Research involvement and engagement · 2025Review
- Digital Informed Consent/Assent in Clinical Trials Among Pregnant Women, Minors, and Adults: Multicountry Cross-Sectional Evaluation of Comprehension and Satisfaction.JMIR human factors · 2025Article
- Describing the content of trial recruitment interventions using the TIDieR reporting checklist: a systematic methodology review.BMC medical research methodology · 2024Article
- Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies.BMC medical ethics · 2021Article
- 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
- Emerging Therapies: Communication, Consent, and Collaboration in Research-Based Treatment.Focus (American Psychiatric Publishing) · 2018Article
- Broad consent for health care-embedded biobanking: understanding and reasons to donate in a large patient sample.Genetics in medicine : official journal of the American College of Medical Genetics · 2018Article
- Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study.Global qualitative nursing researchArticle
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe aim was to evaluate the comprehension of participants of an improved informed consent document (ICD).
methodThis was a randomized controlled French multicentre study performed in real conditions. Participants were adult patients undergoing screening for enrolment in biomedical research studies, who agreed to answer a validated questionnaire evaluating objective and subjective comprehension scored from 0 (no comprehension) to 100 (excellent comprehension). Patients were provided either the original ICD or an ICD modified in terms of structure and readability. The primary end point was the score of objective comprehension. The secondary end-points were the enrolment rate in the clinical study and patient characteristics associated with the score of objective comprehension.
resultsFour hundred and eighty-one patients were included, 241 patients in the original ICD group and 240 patients in the modified ICD group. There was no difference between the two groups for the score of objective comprehension (original ICD 72.7 (95% CI 71.3, 74.1) vs. modified ICD 72.5 (95% CI 71.0, 74.0); P = 0.81). However, the rate of enrolment in the clinical study was lower in the group who received the modified ICD (64.4% (95% CI 58.3, 70.5)) than for the original ICD (73.0% (95% CI 67.4, 78.7)) (P = 0.042). Only female gender and high educational level were associated with a better objective comprehension.
conclusionsImproving ICDs had no effect on participants' understanding, whereas the rate of enrolment was lower in this group. In attempts at improving potential participants' understanding of clinical research information, efforts and future trials should focus on other ways to improve comprehension.
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