Trial reportBritish journal of clinical pharmacology2010
Informed consent document improvement does not increase patients' comprehension in biomedical research.
Trial report in British journal of clinical pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials.BMC medical ethics · 2013Pooled it
- Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.BMC medical ethics · 2016Trial
- Improved participants' understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study.European journal of clinical pharmacology · 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
- How to improve informed consent processes in clinical trials with cancer patients: a qualitative analysis of multidisciplinary experts' perspectives.BMC medical ethics · 2025Article
- Article
- Facilitating Informed Permission/Assent/Consent in Pediatric Clinical Trials.Paediatric drugs · 2019Article
- iCONCUR: informed consent for clinical data and bio-sample use for research.Journal of the American Medical Informatics Association : JAMIA · 2017Article
- Blockchain protocols in clinical trials: Transparency and traceability of consent.F1000Research · 2017Article
- Article
- A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries.PLoS neglected tropical diseases · 2017Article
- Article
- Informed consent: how much awareness is there?PloS one · 2014Article
- Analysis of informed consent document utilization in a minimal-risk genetic study.Annals of internal medicine · 2011Article
- Editors' pick 2010.British journal of clinical pharmacology · 2011Article
- Drug code names and other ethics-related matters.British journal of clinical pharmacology · 2010Article
- Editors' pick 2009.British journal of clinical pharmacology · 2010Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsInternational guidelines on ethics in biomedical research require that the informed consent of all enrolled participants is obtained. A written document describing the research, the informed consent (IC) document, must be given to all participants by the investigator. Most IC documents are long, containing much information. The aim of the present study was to determine whether the modification of the IC document by a working group or systematic improvement in its lexicosyntactic readability can improve comprehension of the written information given to patients participating in biomedical research.
methodsOne hundred and fifty-nine patients were randomized to read one of the three versions of the IC document: unchanged document, document modified using systematic improvement of lexicosyntactic readability and document modified by a working group.
resultsNeither the improvement in the lexicosyntactic readability, nor the intervention of the working group significantly improved the score of objective comprehension for the subjects included in this study: it was 66.6 (95% confidence interval 64.0, 69.2) for the control group, 68.8 (66.2, 71.4) for the group with the document improved for lexicosyntactic readability and 69.2 (66.0, 72.4) for the group who read the document improved by the working group (P= 0.38).
conclusionsWe failed to show that improving IC document comprehension through a lexicosyntactic approach or by a working group leads to better comprehension.
Indexed as
Identifiers
What Socratic 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 Socratic graph.