Reconceptualizing the Informed Consent Process at Eight Innovative Hospitals

Matiasek, Jennifer; Wynia, Matthew K.

doi:10.1016/s1553-7250(08)34015-x

Cited by 16 publications

(24 citation statements)

References 11 publications

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“…A signature on a consent form indicates that the patient has had a detailed conversation with their provider and that the patient understands the purpose, benefits, risks and alternatives of the treatment they are receiving 1,2 . However, consent forms frequently fail to convey any knowledge because they are too complex for the average patient with a low literacy level and risk information is often subjectively interpreted 3,4 .…”

Section: Introductionmentioning

confidence: 99%

“…Providing additional materials such as videos, 5 personalized worksheets, 1 take-home information sheets 6 , illustrations or diagrams 2 , incorporating test/feedback questions 3,7 and formatting changes to create easy to read versions 8 have all been cited as means to improve comprehension for patients with both high and low literacy. Furthermore, numerical presentation rather than relative risk categories and incorporation of graphical representations may facilitate more accurate risk perceptions and improve risk communication between providers and patients 9,10 .…”

Section: Introductionmentioning

confidence: 99%

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From the Patient Perspective, Consent Forms Fall Short of Providing Information to Guide Decision Making

Manta¹,

Ortiz

Moulton

et al. 2016

J Patient Saf

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Objective This study aimed to gather qualitative feedback on patient perceptions of informed consent forms and elicit recommendations to improve readability and utility for enhanced patient safety and engagement in shared decision making. Methods Sixty interviews in personal interviews were conducted consisting of a literacy and numeracy assessment, a comprehension quiz to assess retention of key information, and open-ended questions to determine reactions, clarity of information, and suggestions for improvement. Results Although 68% of the participants had education beyond high school, many still missed comprehension questions and found the forms difficult to read. Recurrent suggestions included specific formatting changes to enhance readability, a need for additional sources of information, mixed attitudes toward inclusion of risk information, and the recognized importance of physician-patient conversations. Conclusions This study provides evidence from the patient perspective that consent forms are too complex and fail to achieve comprehension. Future studies should be conducted using patients’ suggestions for form redesign and inclusion of supplemental educational tools to optimize communication and safety to achieve more informed health care decision making.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

From the Patient Perspective, Consent Forms Fall Short of Providing Information to Guide Decision Making

Manta¹,

Ortiz

Moulton

et al. 2016

J Patient Saf

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“…1,2 Defined as the “process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention,” 2 valid informed consent requires patient understanding of the proposed intervention, including potential risks, benefits, and alternatives. 3 Failure to obtain adequate informed consent compromises patient autonomy, 4,5 places patient safety at risk, 6–8 and legally may constitute negligence or battery. 4,9 …”

mentioning

confidence: 99%

“…Despite its critical importance to the provision of safe, high-quality, patient-centered health care, the process of informed consent in clinical practice is frequently inadequate, 3,10 and prior research has demonstrated that patient comprehension of the key elements of clinical informed consent is often poor. 11,12 Physicians receive little training in how to conduct informed consent discussions.…”

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confidence: 99%

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Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures

et al. 2010

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Background Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources A systematic literature search of English-language articles in MEDLINE (1949–2008) and EMBASE (1974–2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection Randomized controlled trials and controlled trials with non-random allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

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Evaluation of Textbook Outcome as a Composite Quality Measure of Elective Laparoscopic Cholecystectomy

2022

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ImportanceA textbook outcome (TO) is a composite quality measure that incorporates multiple perioperative events to reflect the most desirable outcome. The use of TO increases the event rate, captures more outcomes to reflect patient experience, and can be used as a benchmark for quality improvement.ObjectivesTo introduce the concept of TO to elective laparoscopic cholecystectomy (LC), propose the TO criteria, and identify characteristics associated with TO failure.Design, Setting, and ParticipantsThis retrospective cohort study was performed at 3 surgical units in a single health board in the United Kingdom. Participants included all patients undergoing elective LC between January 1, 2015, and January 1, 2020. Data were analyzed from January 1, 2015, to January 1, 2020.Main Outcomes and MeasuresThe TO criteria were defined based on review of existing TO metrics in the literature for other surgical procedures. A TO was defined as an unremarkable elective LC without conversion to open cholecystectomy, subtotal cholecystectomy, intraoperative complication, postoperative complications (Clavien-Dindo classification ≥2), postoperative imaging, postoperative intervention, prolonged length of stay (>2 days), readmission within 100 days, or mortality. The rate of TOs was reported. Reasons for TO failure were reported, and preoperative characteristics were compared between TO and TO failure groups using both univariate analysis and multivariable logistic regressions.ResultsA total of 2166 patients underwent elective LC (median age, 54 [range, 13-92] years; 1579 [72.9%] female). One thousand eight hundred fifty-one patients (85.5%) achieved a TO with an unremarkable perioperative course. Reasons for TO failure (315 patients [14.5%]) included conversion to open procedure (25 [7.9%]), subtotal cholecystectomy (59 [18.7%]), intraoperative complications (40 [12.7%]), postoperative complications (Clavien-Dindo classification ≥2; 92 [29.2%]), postoperative imaging (182 [57.8%]), postoperative intervention (57 [18.1%]), prolonged length of stay (>2 days; 142 [45.1%]), readmission (130 [41.3%]), and mortality (1 [0.3%]). Variables associated with TO failure included increasing American Society of Anesthesiologists score (odds ratio [OR], 2.55 [95 CI, 1.69-3.85]; P < .001), increasing number of prior biliary-related admissions (OR, 2.68 [95% CI, 1.36-5.27]; P = .004), acute cholecystitis (OR, 1.42 [95% CI, 1.08-1.85]; P = .01), preoperative endoscopic retrograde cholangiopancreatography (OR, 2.07 [95% CI, 1.46-2.92]; P < .001), and preoperative cholecystostomy (OR, 3.22 [95% CI, 1.54-6.76]; P = .002).Conclusions and RelevanceThese findings suggest that applying the concept of TO to elective LC provides a benchmark to identify suboptimal patterns of care and enables institutions to identify strategies for quality improvement.

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Reconceptualizing the Informed Consent Process at Eight Innovative Hospitals

Cited by 16 publications

References 11 publications

From the Patient Perspective, Consent Forms Fall Short of Providing Information to Guide Decision Making

From the Patient Perspective, Consent Forms Fall Short of Providing Information to Guide Decision Making

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures

Evaluation of Textbook Outcome as a Composite Quality Measure of Elective Laparoscopic Cholecystectomy

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