SynthesisTrials2021
The reality of informed consent: empirical studies on patient comprehension-systematic review.
Synthesis in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 111 papers, 4 of them syntheses 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
111 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Brazilian Society of Oncologic Surgery Guideline for Bloodless Surgery (Part 1: Preoperative Strategies).Journal of surgical oncology · 2026Guideline
- Improving Participant Recruitment in Clinical Trials: Comparative Analysis of Innovative Digital Platforms.Journal of medical Internet research · 2024Pooled it
- Trial Participation in Neurodegenerative Diseases: Barriers and Facilitators: A Systematic Review and Meta-Analysis.Neurology · 2024Pooled it
- Pooled it
- Audiovisual Augmentation of Electronic Consent to Improve Consent Rates and Comprehension: A Randomized Clinical Trial.JAMA network open · 2026Trial
- An ancillary care policy in a vaccine trial conducted in a resource-constrained setting: evaluation and policy recommendations.BMJ global health · 2024Trial
- Randomized study of two different consent procedures on recall: a study within a digital alcohol intervention trial.Trials · 2024Trial
- Improving patient communication and understanding of medical reports through text simplification with ChatGPT: a comparative study.Oral and maxillofacial surgery · 2026Article
- Validating LLM judges for automated oversight of patient communication.medRxiv : the preprint server for health sciences · 2026Article
- Ethical Challenges in Research Involving Hospitalized Patients: A Phenomenological Study.Health care analysis : HCA : journal of health philosophy and policy · 2026Article
- Feasibility, acceptability, and usability of a patient decision aid for participation in the DAHANCA 35 proton radiotherapy trial: A qualitative study.Technical innovations & patient support in radiation oncology · 2026Article
- Perceptions of Medical Malpractice Liability and Informed Consent Among Hospital Healthcare Workers: A Cross-Sectional Study.Healthcare (Basel, Switzerland) · 2026Article
- Feasibility, comprehension and applicability of broad consent in the emergency department: an exploratory mixed-methods study.Journal of medical ethics · 2026Article
- Article
- Informed Consent in Orthopaedic Surgery: When a Signature Does Not Mean Understanding: A Prospective Study of 750 Patients Comparing Elective and Trauma Settings.Journal of evaluation in clinical practice · 2026Observational
- Optimizing Development of Plain Language Summaries of Clinical Trial Results.Health literacy research and practice · 2026Article
- Understanding Informed Consent: A Cross-Sectional Study of Objective and Self-Perceived Comprehension in Romania.Healthcare (Basel, Switzerland) · 2026Article
- Participation and Refusal in an Implementation Trial: Insights from the Accelerating Cervical Cancer Elimination through the Integration of Screen-and-Treat Services (ACCESS) Study.Research square · 2026Article
- Development of a multimedia informed consent tool for fixed prosthodontic treatment: A cognitive theory-based approach to enhance patient understanding.PEC innovation · 2026Article
- Japanese hematologists' and oncologists' perceptions of patient preferences for shared decision-making.BMC research notes · 2026Article
51 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients' comprehension of an informed consent's basic components shows that their level of understanding is limited.
methodsSystemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients' comprehension of specific informed consent components.
resultsIn total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators' blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects.
conclusionsWe found that participants' comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients' full and genuine involvement in a shared medical decision-making process.
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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.