The curriculum was embedded in a transition-to-residency course and combined a 90-minute didactic session with a specialty-oriented simulation. Instruction reviewed the ethical foundations of informed consent, including autonomy, and the elements of valid consent: information, comprehension and voluntariness. It also addressed communication of treatment choices, risks, benefits and alternatives, engagement of patients and families, alignment of decisions with patient goals and values, documentation, and the use of clinical scenarios to practice the skills. Students had received no previous formal instruction on informed consent before the course. Within two weeks of the didactic session, students entered a specialty track aligned with their planned residency and received materials for independent study of a common procedure, including its indications, risks, complications and expected postoperative course.

Each simulation followed a structured sequence: a 10-minute faculty-student briefing, a 15-minute standardized-patient encounter, five minutes of individualized feedback and a 10-minute group debrief. During the encounter, students were expected to confirm the patient’s history, establish rapport, discuss the proposed procedure and obtain verbal and written informed consent. The scenarios were selected by specialty-track faculty leads from procedures commonly performed in their fields. The research analyzed three surgery-based procedures: laparoscopic cholecystectomy, joint replacement and caesarean section. Across the two academic years, 325 fourth-year students received the curriculum, including 252 entering medicine-based and 73 entering surgery-based residency pathways. Among the surgery-based group, 36 students completed the laparoscopic-cholecystectomy scenario, 21 completed the joint-replacement scenario and 16 completed the caesarean-section scenario.

Student performance was rated with a newly developed formative assessment containing 22 line items: 11 patient-centered and 11 procedure-centered communication skills. Each item was scored from 0 to 2, indicating that the behavior was not demonstrated, partially demonstrated or fully demonstrated. The tool included areas such as rapport-building, active listening, communicating the proposed procedure, teach-back, shared decision-making and inviting questions, while also reflecting the American College of Surgeons criteria for informed consent. Standardized patients completed the assessment immediately after the encounter and used it to guide individualized verbal feedback. The standardized patients and their trainers received training from the senior author in using the assessment and delivering feedback. Because the tool was newly created, its reliability and validity had not yet been established when the study was conducted.

The investigators converted the ratings into percentages and used paired-sample t-tests to compare patient-centered and procedure-centered performance within each procedure group. One-way analysis of variance compared the three groups on total, patient-centered and procedure-centered scores, with a p-value below 0.05 considered statistically significant. Among all 73 surgery-bound students, the procedure-centered communication mean was 84.0%, compared with 79.1% for patient-centered communication; the difference was statistically significant, with t(72) = −2.975 and p = 0.004. Procedure-centered scores also exceeded patient-centered scores in the caesarean-section group, at 79.2% versus 77.7%, with p = 0.005, and in the laparoscopic-cholecystectomy group, at 87.0% versus 77.9%, with p < 0.001. The joint-replacement group showed no significant within-group difference between the two categories, with p = 0.329.

Mean total scores were similar across the three procedures: 82.5% for laparoscopic cholecystectomy, 80.7% for joint replacement and 80.5% for caesarean section. The analysis detected no significant difference among procedure groups in total scores, with F(2,70) = 0.277, p = 0.759 and η² = 0.008. Differences were also not significant for patient-centered scores, with p = 0.367, or procedure-centered scores, with p = 0.083. The joint-replacement group had the highest descriptive patient-centered average at 82.3%, compared with 77.9% for laparoscopic cholecystectomy and 77.7% for caesarean section. Laparoscopic cholecystectomy students had the highest descriptive procedure-centered average at 87.0%, compared with 79.2% in each of the other groups. These descriptive differences did not establish a statistically reliable advantage for any procedure. Overall performance was also similar between students who received the didactic session in class and those who viewed it on demand in the second academic year, although the study did not report a detailed statistical comparison of the two delivery modes.

Item-level results identified three behaviors below 60% in every procedure group: checking whether the patient wanted a family member or friend present for the discussion, soliciting the patient’s goals for treatment, and checking for understanding. Performance also varied by procedure. Joint-replacement students scored below 60% on discussing surgical risks and discussing alternatives to the procedure, while laparoscopic-cholecystectomy students scored below 60% on demonstrating respect for the patient as a person. All remaining items exceeded 60% within the reported groups. The authors said the pattern may reflect insufficient instruction, limited student skills or features of the assessment instrument, but the study did not distinguish among those explanations. Their findings indicate that the assessment identified specific behaviors that were consistently weak in this cohort and could be targeted in subsequent instruction and practice.

Students’ end-of-course evaluations were more positive than the item-level performance results. In the anonymous transition-to-residency survey, 86.8% strongly agreed or agreed that the simulation prepared them to obtain informed consent for common procedures during internship, and 100% strongly agreed or agreed that they felt comfortable obtaining informed consent. These questions measured student reaction, corresponding to Level 1 of the Kirkpatrick evaluation framework. They were not independent tests of competence, observations of unsupervised clinical performance or measures of skill retention. The survey findings therefore show that students generally regarded the curriculum as useful and reported feeling prepared, while the standardized-patient ratings show that performance was not uniform across every assessed communication behavior. The study also did not measure whether the curriculum caused the observed scores, because no pretest or baseline assessment was collected.

The study has several limitations that constrain how broadly its findings can be applied. It included two cohorts of graduating fourth-year students from a single medical school, and the analyzed sample was limited to students entering surgical pathways and practicing three surgical procedures. The results may not generalize to other institutions, medical students with different prior training, non-surgical procedures such as blood transfusion or residents in other specialties. Although the participating students had received no formal informed-consent instruction before the course, the researchers assumed baseline knowledge after their clerkships and did not administer a pre-assessment. Performance after graduation was unavailable, so the study could not determine whether students transferred or retained the assessed skills during internship. In addition, the formative assessment tool required further validation and reliability testing, including future work on its factor structure. The curriculum was evaluated as an educational intervention in one setting, and the results do not demonstrate improved patient outcomes, fewer litigation risks or independent clinical competence in every residency environment.

Within those limits, the research offers a detailed educational model for examining one of the professional activities expected of new physicians. The program combined explicit teaching, independent study of a relevant procedure, a standardized-patient encounter, behavior-by-behavior assessment, immediate individualized feedback and group reflection. Its most consistent quantitative finding was the higher observed performance in procedure-centered than patient-centered communication, accompanied by low scores for checking understanding, eliciting treatment goals and asking whether patients wanted support from family or friends. The study also showed that students’ reports of comfort did not guarantee equal performance on every item. Future work identified by the investigators will refine the assessment tool, evaluate its reliability and gather validity evidence, while performance during internship will need separate evaluation. Until those data are available, the curriculum is best understood as a promising, highly rated educational approach with measurable simulation performance and clearly identified communication gaps, rather than proof of readiness for unsupervised consent discussions in clinical practice.

Subject of Research: Evaluation of an informed-consent curriculum and formative assessment for final-year medical students entering surgical residencies

Article Title: Evaluation of an informed consent (EPA11) curriculum and feedback in the transition to residency course for surgical residencies

Article References: Cash, C. A., & Hagopian, E. J. (2026). Evaluation of an informed consent (EPA11) curriculum and feedback in the transition to residency course for surgical residencies. Global Surgical Education – Journal of the Association for Surgical Education, 5(1), Article 202. https://doi.org/10.1007/s44186-026-00604-5

Image Credits: AI Generated

DOI: 10.1007/s44186-026-00604-5

Keywords: informed consent, medical education, standardized patients, surgical training, simulation, formative assessment, communication skills, residency preparation, shared decision-making, medical students, Evaluation, informed