An instrument for assessing the quality of informed consent documents for elective procedures: development and testing.

To develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures. Mixed qualitative-quantitative approach. Convened seven meetings with stakeholders to obtain input and feedback on the tool. Team 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. With 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. Abstraction tool to evaluate the quality of informed consent documents. We 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%. We 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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Déclaration de conflit d'intérêts

Competing interests: The authors of this manuscript receive support to develop quality measures for the Centers for Medicare and Medicaid Services for public reporting. The informed consent measure is not currently implemented but was made publicly available so that hospitals could use the measure as a self-evaluation tool. The authors report working under contract with the Centers for Medicare and Medicaid Services to support quality measurement programmes, including developing a measure of informed consent document quality. The measure is not currently part of any quality reporting programmes, although the Centers for Medicare and Medicaid Services has made publicly available for use by hospitals to support quality improvement efforts. ES also reports receiving support from the Food and Drug Administration to support projects within the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI); from the National Institute on Minority Health and Health Disparities (U54MD010711-01) to study precision-based approaches to diagnosing and preventing hypertension; and from the National Institute of Biomedical Imaging and Bioengineering (R01 EB028106-01) to study a cuff-less blood pressure device. HMK also reports being a recipient of a research grant, through Yale, from Medtronic and the US Food and Drug Administration to develop methods for postmarket surveillance of medical devices; was a recipient of a research grant with Medtronic and is the recipient of a research grant from Johnson & Johnson, through Yale University, to support clinical trial data sharing; was a recipient of a research agreement, through Yale University, from the Shenzhen Center for Health Information for work to advance intelligent disease prevention and health promotion; collaborates with the National Center for Cardiovascular Diseases in Beijing; receives payment from the Arnold & Porter Law Firm for work related to the Sanofi clopidogrel litigation, from the Ben C Martin Law Firm for work related to the Cook Celect IVC filter litigation, and from the Siegfried and Jensen Law Firm for work related to Vioxx litigation; chairs a Cardiac Scientific Advisory Board for UnitedHealth; was a participant/participant representative of the IBM Watson Health Life Sciences Board; is a member of the Advisory Board for Element Science, the Advisory Board for Facebook and the Physician Advisory Board for Aetna; and is the cofounder of Hugo Health, a personal health information platform, and cofounder of Refactor Health, an enterprise healthcare AI-augmented data management company.