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Assessing elements of informed consent among living donors.

ABSTRACT: Living organ donors - 50% of solid organ donors in the United States - represent a unique population who accept medical risk for the benefit of another. One of the main justifications for this practice has been respect for donor autonomy, as realized through informed consent. In this retrospective study of living donors, we investigate two key criteria of informed consent: (i) depth of understanding and (ii) degree of voluntariness. In our survey of 262 living kidney donors 2-40 months post-donation, we found that more than 90% understood the effects of living donation on recipient outcomes, the screening process, and the short-term medical risks of donation. In contrast, only 69% understood the psychological risks of donation; 52% the long-term medical risks of donation; and 32% the financial risks of donation. Understanding the effects of living donation on recipient outcomes was the only factor that would affect donors' decision to donate again. A total of 40% of donors reported feeling some pressure to donate. Donors who are related to the recipient were more likely to report feeling pressure to donate. We conclude that more studies of informed consent are needed to identify factors that may compromise the validity of informed consent.

SUBMITTER: Valapour M

PROVIDER: S-EPMC3070767 | biostudies-literature | 2011 Mar-Apr

REPOSITORIES: biostudies-literature

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Assessing elements of informed consent among living donors.

Valapour M M Kahn J P JP Bailey R F RF Matas A J AJ

Clinical transplantation 20101216 2

Living organ donors - 50% of solid organ donors in the United States - represent a unique population who accept medical risk for the benefit of another. One of the main justifications for this practice has been respect for donor autonomy, as realized through informed consent. In this retrospective study of living donors, we investigate two key criteria of informed consent: (i) depth of understanding and (ii) degree of voluntariness. In our survey of 262 living kidney donors 2-40 months post-dona ...[more]

PMID: 21158924

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Project description:Informed consent discussions for elective abdominal aortic aneurysm (AAA) repair should reflect appropriate risks of the open or endovascular repair (EVAR), but few guidelines exist describing what surgeons should discuss. This study examines expert opinion regarding what constitutes informed consent.Design. We conducted an anonymous, web-based, national survey of vascular surgeons. Associations between surgeon characteristics and opinions regarding informed consent were measured using bivariate statistics; multivariable logistic regression was performed to estimate effects adjusted for covariates. Setting. Academic and private practice surgeons were surveyed. Subjects. United States members of the International Society for Vascular Surgery membership. Main Outcome Measure. Surgeons' self-reported opinions regarding the content of informed consent for AAA repair.A total of 199 surgeons completed the survey (response rate 51%). More than 90% of respondents reported that it was essential to discuss mortality risk for both procedures. However, only 60% and 30% of respondents reported that it was essential to discuss the risk of myocardial infarction and stroke, respectively. Opinions varied by procedure regarding the risks of impotence (32% vs 62%; EVAR vs open repair), reintervention (78% vs 17%), and rupture during long-term follow-up (57% vs 17%). Younger and private practice surgeons were more likely to discuss complications compared with older surgeons and those in academic practice. Surgeons who perform predominantly EVAR were more likely to quote higher mortality rates for open repair (odds ration [OR] = 3.1, 95% confidence interval [CI] = 1.4-6.4) and lower reintervention rates for EVAR (OR = 0.3, 95% CI = 0.1-0.7) compared with other surgeons.This is the first study of the practice of informed consent for AAA repair. The only risk that the vast majority of surgeons agreed should be included in informed consent for AAA repair was mortality. Significant variation exists regarding whether other complications should be discussed and what complication rates should be quoted. Surgeon characteristics may influence how risks are presented to patients. Further efforts are needed to develop guidelines to ensure consistent communication of appropriate risk during informed consent for AAA repair.

Project description: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.OutcomesAbstraction 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.

Dataset Information

Assessing elements of informed consent among living donors.

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Assessing elements of informed consent among living donors.

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