ArticleBMC medical ethics2016
Readability of patient information and consent documents in rheumatological studies.
Article in BMC medical ethics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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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.
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Who cites it
15 citing papers in PubMed.
- Decoupled quality and readability in skin cancer education from large language models.Frontiers in public health · 2026Article
- Using ChatGPT-4 for Lay Summarization in Prostate Cancer Research to Advance Patient-Centered Communication: Large-Scale Generative AI Performance Evaluation.Journal of medical Internet research · 2025Article
- [Making prostate cancer research accessible: chatGPT-4 as a tool to enhance lay communication].Urologie (Heidelberg, Germany) · 2025Article
- Readability of health research informed consent forms: case of the National Health Research Ethics Committee in Tanzania.BMC medical ethics · 2025Article
- Lessons to be learned when designing comprehensible patient-oriented online information about temporomandibular disorders.Journal of oral rehabilitation · 2025Article
- Readability of Informed Consent Forms for Medical and Surgical Clinical Procedures: A Systematic Review.Clinics and practice · 2025Review
- Article
- The hidden health equity crisis: readability assessment of online information regarding periodontitis-diabetes relationship.Frontiers in public health · 2025Article
- Readability analysis of ChatGPT's responses on lung cancer.Scientific reports · 2024Article
- IVC filter - assessing the readability and quality of patient information on the Internet.Journal of vascular surgery. Venous and lymphatic disorders · 2024Review
- Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review.BMC medical ethics · 2023Article
- An evaluation of the process of informed consent: views from research participants and staff.Trials · 2021Article
- Article
- Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration.Ochsner journal · 2020Review
- How one small text change in a study document can impact recruitment rates and follow-up completions.Internet interventions · 2019Article
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
No grant is acknowledged in the PubMed record.
Abstract
backgroundBefore participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands, Denmark, and Norway.
methods24 PICDs from studies were collected and readability was assessed independently using the Gunning's Fog Index (FOG) and Simple Measure of Gobbledygook (SMOG) grading.
resultsThe mean score for the FOG and SMOG grades were 14.2 (9.0-19.0) and 14.2 (12-17) respectively. The mean FOG and SMOG grades were 12.7 and 13.3 in the Dutch studies, 15.0 and 14.9 in the Danish studies, and 14.6 and 14.3 in the Norwegian studies, respectively. Out of the 2865 participants, more than 57 % had a lower educational level than the highest readability score calculated in the individual study.
conclusionsAs the readability level of the PICDs did not match the participants' educational level, consent may not have been valid, as the participants may have had a limited understanding of what they agreed to participate in. There should be more focus on the readability of PICDs. National guidelines for how to write clear and unambiguous PICDs in simple and easily understandable language could increase the focus on the readability of PICD.
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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.