Improving Surgical Informed Consent: Unanswered Questions.

Objective: This study reviews randomized clinical trials that have attempted to improve the process of informed consent. Consent should be guided by the ethical imperatives of autonomy, beneficence, and social justice. Summary Background: Informed consent is constantly evolving. Yet our review of the randomized trials done to improve the surgical informed consent process raises a number of questions: How does one define surgical informed consent? What interventions have been tried to measure and improve informed consent? Have the interventions in informed consent actually led to improvements? What efforts have been made to improve informed consent? And what steps can be taken to improve the process further? Methods: A literature search for randomized controlled trials (RCTs)on informed consent identified 70 trials. Demographics, interventions, assessments, and a semi-quantitative summary of the findings were tabulated. The assessments done in the RCTs, show the surrogate for patient autonomy was comprehension; for beneficence, satisfaction and mental state (anxiety or depression); and, for social justice, language, literacy, learning needs, and cost. Results: There were 4 basic categories of interventions: printed matter; non-interactive audiovisual tools; interactive multimedia; and a smaller group defying easy description. Improvement was documented in 46 of the 65 trials that studied comprehension. Thirteen of 33 trials showed improved satisfaction. Three of 30 studies showed an increase in anxiety. Few studies tried to assess primary language or literacy, and none looked at learning needs or cost. Conclusions: No single study improved all 3 principles of informed consent. Validated interventions and assessments were associated with greater impact on outcomes. All 3 ethical principles should be assessed; autonomy (as comprehension), beneficence (as satisfaction, anxiety), and social justice. Not enough consideration has been given to social justice; appropriate language translation, standardized reading levels, assessment of learning needs, and cost to the individual are all important elements worthy of future study.

Taking the Initiative: Risk-Reduction Strategies and Decreased Malpractice Costs.

BACKGROUND: To heighten awareness of attending and resident surgeons regarding strategies for defense against malpractice claims, a series of risk reduction initiatives have been carried out in our Department of Surgery. We hypothesized that emphasis on certain aspects of risk might be associated with decreased malpractice costs. The relative impact of Department of Surgery initiatives was assessed when compared with malpractice experience for the rest of the Clinical Practices of the University of Pennsylvania (CPUP). STUDY DESIGN: Surgery and CPUP malpractice claims, indemnity, and expenses were obtained from the Office of General Counsel. Malpractice premium data were obtained from CPUP finance. The Department of Surgery was assessed in comparison with all other CPUP departments. Cost data (yearly indemnity and expenses), and malpractice premiums (total and per physician) were expressed as a percentage of the 5-year mean value preceding implementation of the initiative program. RESULTS: Surgery implemented 38 risk reduction initiatives. Faculty participated in 27 initiatives; house staff participated in 10 initiatives; and advanced practitioners in 1 initiative. Department of Surgery claims were significantly less than CPUP (74.07% vs 81.07%; p < 0.05). The mean yearly indemnity paid by the Department of Surgery was significantly less than that of the other CPUP departments (84.08% vs 122.14%; p < 0.05). Department of Surgery-paid expenses were also significantly less (83.17% vs 104.96%; p < 0.05), and surgical malpractice premiums declined from baseline, but remained significantly higher than CPUP premiums. CONCLUSIONS: The data suggest that educating surgeons on malpractice and risk reduction may play a role in decreasing malpractice costs. Additional extrinsic factors may also affect cost data. Emphasis on risk reduction appears to be cumulative and should be part of an ongoing program.

Tipping the scales: educating surgeons about medical malpractice.

BACKGROUND: In Pennsylvania, medical malpractice premiums are a major cost to surgeons. Yet surgeons often have little if any education in the basics of tort litigation or how to manage their risk. This work describes one approach for educating academic faculty surgeons on current concepts of medical malpractice and provide some guidance on how to "tip the scales of justice"; or minimize the risks of being named in a malpractice claim. MATERIALS AND METHODS: The course had five parts: the basics of medical malpractice, the cost of malpractice insurance, current departmental claims experience, strategies for decreasing the risk of being named in a claim, and an overview of malpractice reforms. An anonymous seven question survey was cast in a five-point Likert scale format. A weighted average of 4.5 or above was considered satisfactory. Two free text questions asked about positive and negative aspects of the course. RESULTS: Eighty of 95 (84%) faculty attended either in person or by reviewing a web-based video. Quantitatively, five of seven questions had a weighted average of more than 4.5 (n = 48, response rate = 60%). Qualitatively, the course was reviewed very favorably. CONCLUSIONS: The high percentage of participation and overall survey results suggest that the course was successful. This course was one facet of an approach to decrease the risk of malpractice claims. Unique aspects of this course include an emphasis on state law, department-specific data, and strategies to minimize risk of future claims. Given the state-specific nature of malpractice claims and litigation, individual departments must particularize similar presentations.