Informed Consent for Cardiac Procedures: Deficiencies in Patient Comprehension With Current Methods

Dathatri, Shubha; Gruberg, Luis; Anand, Jatin; Romeiser, Jamie; Sharma, Shephali; Finnin, Eileen; Shroyer, A. Laurie; Rosengart, Todd K.

doi:10.1016/j.athoracsur.2013.12.065

Cited by 20 publications

(15 citation statements)

References 18 publications

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“…Specific methods to improve communication have been proposed, including shared decision making, 25,26 decision aids, 27,28 and standardized consent documents, 9 but few have been tested. 29 Most recently, the Joint Commission and the American Medical Association sponsored a National Summit on Overuse 30 in which they identified elective PCI as 1 of 5 overused practices. In response, they recommended that physicians (1) ensure patients are aware of the benefits and risks of PCI and (2) educate the public that PCI is not appropriate in all cases.…”

Section: Discussionmentioning

confidence: 99%

Informed Decision Making for Percutaneous Coronary Intervention for Stable Coronary Disease

et al. 2015

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IMPORTANCE Patients with stable coronary disease undergoing percutaneous coronary intervention (PCI) are frequently misinformed about the benefits of PCI. Little is known about the quality of decision making before angiography and possible PCI. OBJECTIVE To assess the quality of informed decision making and its association with patient decisions. DESIGN, SETTING, AND PARTICIPANTS We performed a cross-sectional analysis of recorded conversations between August 1, 2008, and August 31, 2012, among adults with known or suspected stable coronary disease at outpatient cardiology practices.MAIN OUTCOMES AND MEASURES Presence of 7 elements of informed decision making and the decision to undergo angiography and possible PCI. RESULTSOf 59 conversations conducted by 23 cardiologists, 2 (3%) included all 7 elements of informed decision making; 8 (14%) met a more limited definition of procedure, alternatives, and risks. Specific elements significantly associated with not choosing angiography and possible PCI included discussion of uncertainty (odds ratio [OR], 20.5; 95% CI, 2.3-204.9), patient's role (OR, 5.3; 95% CI, 1.3-21.3), exploration of alternatives (OR, 9.5; 95% CI, 2.5-36.5), and exploration of patient preference (OR, 4.8; 95% CI, 1.2-19.4). Neither the presence of angina nor severity of symptoms was associated with choosing angiography and possible PCI. In a multivariable analysis using the total number of elements as a predictor, better informed patients were less likely to choose angiography and possible PCI (OR per additional element, 3.2; 95% CI, 1.4-7.1; P = .005). CONCLUSIONS AND RELEVANCEIn conversations between cardiologists and patients with stable angina, informed decision making is often incomplete. More complete discussions are associated with patients choosing not to undergo angiography and possible PCI.

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Section: Discussionmentioning

confidence: 99%

Informed Decision Making for Percutaneous Coronary Intervention for Stable Coronary Disease

et al. 2015

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“…This lack of understanding may be due, in part, to an inability to understand the implications of major surgery and recovery. Studies examining how patients process information during discussion of informed consent suggest that only one-third of patients understand conveyed information well enough to make a truly informed decision regarding their care, 28 and that patients frequently forget vital information about procedures 29 . For many patients, hospitals are foreign, intimidating, and not conducive to absorbing new and important information.…”

Section: Discussionmentioning

confidence: 99%

Using Human Factors and Systems Engineering to Evaluate Readmission after Complex Surgery

Acher

LeCaire

Hundt

et al. 2015

Journal of the American College of Surgeons

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OBJECTIVE To utilize a human factors and systems engineering approach to understand contributors to surgical readmissions from a patient and provider perspective. BACKGROUND Prior studies on readmission neglect the patient perspective. To address this gap and to better inform intervention design, we evaluated how transitions of care relate to and influence readmission from the patient and clinician perspective using the Systems Engineering Initiative for Patient Safety (SEIPS) model. METHODS Patients readmitted within 30 days of discharge following complex abdominal surgery were interviewed. A focus group of inpatient clinician providers was conducted. Questions were guided by the SEIPS framework and content analyzed. Data were collected concurrently from the medical record for a mixed-methods approach. RESULTS Readmission occurred at a median 8 days (range, 1–25) following discharge. All patients had follow-up scheduled with their surgeon, but readmission occurred prior to this in 72% of patients. Primary readmission diagnoses included infection, gastrointestinal complications, and dehydration. Patients (n=18) and clinician providers (n=6) identified a number of factors during the transition of care that may have contributed to readmission, including poor patient and caregiver understanding; inadequate discharge preparation for home care; insufficient educational process and materials, negatively impacted by electronic health record design; and inadequate care team communication. CONCLUSIONS This is the first study to utilize a human factors and systems engineering approach to evaluate the impact of the quality of the transition of care and its influence on readmission from the patient and clinician perspective. Important targets for future interventions include enhancing the discharge process, improving education materials, and increasing care team coordination, with the overarching theme that improved patient and caregiver understanding and engagement are essential to decrease readmission and post-discharge health care utilization.

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“…However, in which actual way donors of iPSCs should be informed and voluntary consent should be acquired remains unclear in the reviewed literature. Inadequate understanding of informed consent has been observed both in research [36,53] and other areas of medicine [54]. Given the level of complication of the iPSC research, its methodology, and implications, standard procedures of donor information may not achieve the assumed aim.…”

Section: Discussionmentioning

confidence: 99%

Donor information in research and drug evaluation with induced pluripotent stem cells (iPSCs)

Orzechowski¹,

Schochow²,

Kühl

et al. 2020

Stem Cell Res Ther

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Background: The discovery of induced pluripotent stem cells (iPSCs) opened the possibilities for reprogramming cells back to a pluripotent state. Because of no apparent ethical issues connected with donation and derivation of biomaterial, iPSCs are considered as a research alternative to ethically highly disputed human embryonic stem cells (hESCs). However, the unique character of iPSCs leads to numerous ethical considerations, which mainly concern the issue of donor information and consent for the use of biospecimen in research and drug evaluation. Methods: For the purpose of this analysis, we conducted a review of the literature in the PubMed/MEDLINE and Web of Science databases. The search algorithm led to the identification of 1461 results. After removing duplicates and screening of title and abstract, 90 articles were found to be relevant to the study's objective. Full texts of these articles were apprised and 62 articles were excluded at this step for not properly addressing the study's objective. In the final step, 28 articles were included in the analysis. Analyzed were both research and non-research manuscripts published in peer-reviewed journals. Results: In the case of iPSC research, the information process should be guided by general frameworks established for research on human subjects but also by specific characteristics of iPSCs. We determined four main domains and 12 thematic subdomains that should be included in donor information. Our results show that majority of authors agree to the content of information with regard to the areas of general information, storage of cells, and protection of privacy. Two main issues that are discussed in the literature are donor's consent for use in future studies and the process of donor information. Conclusions: Given the unique character of iPSCs and the possibility of their various uses in the future, the content of donor information should contain specific information central to iPSC research. Effective methods of communicating information to donors should combine written and oral information with the possible use of multimedia.

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Informed Consent for Cardiac Procedures: Deficiencies in Patient Comprehension With Current Methods

Cited by 20 publications

References 18 publications

Informed Decision Making for Percutaneous Coronary Intervention for Stable Coronary Disease

Informed Decision Making for Percutaneous Coronary Intervention for Stable Coronary Disease

Using Human Factors and Systems Engineering to Evaluate Readmission after Complex Surgery

Donor information in research and drug evaluation with induced pluripotent stem cells (iPSCs)

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