ArticleBMJ open2020
An instrument for assessing the quality of informed consent documents for elective procedures: development and testing.
Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Quality of Cancer-Related Information on New Media (2014-2023): Systematic Review and Meta-Analysis.Journal of medical Internet research · 2025Pooled it
- The Function of Non-invasive Prenatal Testing (NIPT) Request Forms in the Australian Context.Health care analysis : HCA : journal of health philosophy and policy · 2026Article
- Article
- Bridging the literacy gap for surgical consents: an AI-human expert collaborative approach.NPJ digital medicine · 2024Article
- Generative AI: in rescue of healthcare reformation.World journal of urology · 2023Article
- ChatGPT and most frequent urological diseases: analysing the quality of information and potential risks for patients.World journal of urology · 2023Article
- Minimum standard assessment of informed consent for internal medicine transition to residency program: A cohort study.Health science reports · 2023Article
- The Quality of Informed Consent in Caesarean Section at a Tertiary Hospital in Addis Ababa, Ethiopia.International journal of women's health · 2022Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
objectiveTo develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.
designMixed qualitative-quantitative approach.
settingConvened seven meetings with stakeholders to obtain input and feedback on the tool.
participantsTeam of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country.
interventionsWith stakeholder input, we identified elements of high-quality informed consent documents, aggregated into three domains: content, presentation and timing. Based on this comprehensive taxonomy of key elements, we convened the working group to offer input on the development of an abstraction tool to assess the quality of informed consent documents in three phases: (1) selecting the highest-priority elements to be operationalised as items in the tool; (2) iteratively refining and testing the tool using a sample of qualifying informed consent documents from eight hospitals; and (3) developing a scoring approach for the tool. Finally, we tested the reliability of the tool in a subsample of 250 informed consent documents from 25 additional hospitals. OUTCOMES: Abstraction tool to evaluate the quality of informed consent documents.
resultsWe identified 53 elements of informed consent quality; of these, 15 were selected as highest priority for inclusion in the abstraction tool and 8 were feasible to measure. After seven cycles of iterative development and testing of survey items, and development and refinement of a training manual, two trained raters achieved high item-level agreement, ranging from 92% to 100%.
conclusionsWe identified key quality elements of an informed consent document and operationalised the highest-priority elements to define a minimum standard for informed consent documents. This tool is a starting point that can enable hospitals and other providers to evaluate and improve the quality of informed consent.
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