A Multi-Institutional Informed Consent Proposal as a Prevention Tool for Combined Oral Contraceptive Intake and Thrombotic Risk
Marina Vinciguerra, Eliano Cascardi, Bruno Lamanna, Maricla Marrone, Fortunato Pititto, Enrica Macorano, Romualdo Sciorio, Giorgio Maria Baldini, Antonio Malvasi, Andrea Ballini, Gerardo Cazzato, Antonella Vimercati, Senthil Kumaran, Ettore Cicinelli, Salvatore Scacco, Miriam Dellino
Journal of Personalised Medicine, 27 March 2023
Open Access
Abstract
Combined oral contraceptives (COC), are among the most widely used contraceptive methods in the world today. Despite the different changes in terms of estrogen/progestogen combinations and dosages, the thromboembolic risk for a woman who takes combined oral contraceptives persists to date.
Methods
The review of relevant literature and international guidelines on prescription of combined oral contraceptives made it possible to create a proposal for informed consent to be used for prescribing.
Results
The several sections of our consent proposal were designed according to a rationale in order to cover all the aspects presented by worldwide guidelines: how to take, adverse effects, advertisements, extra-contraceptive benefits and effects, a checklist for condition at risk of thromboembolism, the signature of the woman.
Conclusions
An informed consent to standardize combined oral contraceptives prescription can improve women’s eligibility, mitigate thromboembolic risk, and assure legal protection to healthcare providers. In this systematic review in particular, we refer to the Italian medical–legal scenario, to which our group of researchers belongs. However, the model proposed was designed in the respect of main healthcare organization guidelines, and it could be easily used by any center in the world.

Measuring Impact of Simulation-Based Informed Consent Training on Surgical Intern’s Long-Term Confidence
Original Reports
Gwyneth A. Sullivan, Kelly Harmon, Genevieve F. Gill-Wiehl, Seungjun Kim, Jose M. Velasco, Edie Y. Chan, Scott W. Schimpke
Journal of Surgical Education, 24 March 2023
Objective
Our objective was to evaluate the outcome of a training program on long-term confidence of interns and attending physicians.
Design
In this prospective cohort study, general surgery interns underwent a training program on informed consent that involved didactics, standardized patient encounters, and supplemental procedure specific guides at the start of the academic year. At the end of the academic year, we surveyed interns from the classes of 2020 (trained) and 2019 (untrained) about their experience and confidence in obtaining an informed consent. Further, we queried attending physicians on their experience and confidence in the interns at the end of each academic year.
Setting
Single academic general surgery residency program based at 2 urban tertiary hospitals.
Participants
General surgery interns including unmatched preliminary residents and categorical interns from general surgery, interventional radiology, and urology.
Results
Twenty-four incoming interns participated in the training program. Intern confidence discussing operation benefits improved from a median score of 4 to 5 (p = 0.03), and total confidence improved from a median score of 15 to 17.5 (p = 0.08). There was no difference in median total confidence scores (15 vs. 17.5; p = 0.21) between classes. Attending physicians had similar median total confidence scores following intervention (10 vs. 11; p = 0.87). Intern satisfaction was 80% with the didactic session, and 90% with standardized patient encounters. Twenty percent of learners used the supplemental procedure specific guides.
Conclusions
Implementation of an intern targeted program on informed consent that incorporated didactics and standardized patient encounters was viewed as useful and may contribute to long-term improvements in confidence.

Editor’s note: The publication refers to research conducted by members of Rush University Medical Center in Chicago, Illinois.

Informed Consent in Reproductive Therapy
Book Chapter
Ofra G. Golan
Hot Topics in Human Reproduction, 17 March 2023 [Springer]
Abstract
This chapter examines the unique aspects of informed consent to reproductive therapy. It discusses the significance of the informed consent process for this patients’ population, as the core of patient-centered care. Professionals’ and patients’ perception of the process are reviewed, as well as relevant case law. Further, the issues that are most important for patients are revealed, and some guidance is given accordingly as to the information on which emphasis should be put and to the decision points toward which it should be explained and discussed with the patients.

Evaluating the Efficacy of Surgical Consent
Carlos A. Delgado, Michelle R. McCullers, Scott W. Bloom
The American Surgeon, 15 March 2023
Abstract
Background
Patient autonomy is the most important of the core values of medical ethics, yet the process of obtaining surgical consent remains a lesser scrutinized area of modern surgical practice. Informed consent implies a patient’s understanding of nature of the operation, indications, risks, benefits, and alternatives. Surgical consent has traditionally been obtained through verbal communication and formalized by signing a legal document. This process oftentimes leaves patients unequipped with adequate knowledge about the procedure they just consented to. In most cases, it is simply impossible for the non-medically trained layperson to fully understand the nuances of surgery in a conversation. Some may argue a degree of paternalism may be inevitable; we believe there is room for improvement.
Methods
We chose to examine English-speaking adult patients undergoing common procedures (laparoscopic cholecystectomy, open inguinal hernia repair, and skin mass/soft tissue excision). We asked 71 patients to complete a free response survey on the risks, benefits, and alternatives to the operation they had just consented to. The patients were administered the survey either in the outpatient clinic or in the preoperative area.
Results
Our analysis showed that most of our patients understand the inherent risks, benefits, and alternatives when being consented but that less than 50% of those consented were considered to have adequate understanding of the procedures they were consented for.
Discussion
This study highlights key deficits and potential areas of improvement in the informed consent process. Based on the results, we have significant room for improvement and the responsibility to do so.

Comparison of the Structured Consent Process Using Modified Delphi Technique with the Standard Process in Obtaining Informed Consent for Procedures in ENT by PHASE III MBBS Students
Original Article
Sapna Sreedharan Nambiar
Indian Journal of Otolaryngology and Head & Neck Surgery, 15 March 2023
Open Access
Abstract
Communication skill is a core competency and the training must begin in the undergraduate period itself. The Phase III MBBS students during their ENT posting are required to obtain informed consent for procedures and surgeries in ENT which forms the basis for efficient communication skills in house-surgency (internship) and residency. Informed consent taking is an important aspect and in the clinical postings, the teaching of communication skills along with history taking and physical examination can go a long way in making a strong foundation to good doctor patient relationships. This study aimed to compare the structured consent process using modified Delphi technique with the standard process in obtaining informed consent for procedures in ENT by PHASE III MBBS students. The need to sensitise the MBBS students on appropriate consent taking procedures with familiarisation of the essential elements of the Kalamazoo consensus statement were raised, accepted and final OSCE assessment attributes decided by the modified Delphi technique. The Modified Delphi technique is a unique means to obtain opinions of experts across the field in various spheres so as to identify lacunae if any in the existing teaching with means to reach a valid and reliable consensus. Our study included Phase III MBBS students posted to the Department of ENT, Govt Medical College Kozhikode during Jan–Feb 2022 wherein one batch of 30 students were taught with 2 classes on informed consent taking by the structured process obtained after Modified Delphi technique and included as; “MD” group and another batch of 30 students from the entire batch taught by the standard process was included as; “T” group respectively. After completion of the clinical postings an assessment was carried out with OSCE stations in Mar 2022; wherein 10 students were evaluated for each of the 6 common ENT procedures, 5 students from “T” group and 5 students from “MD” group respectively. Median total score of MD group was 6.5 (3.25–8) and median score of T group was 4.5 (2.25–6.75). The difference in mean ranks of these scores was statistically significant, p < 0.0001. The feedback assessment using the questionnaire with Likert scale had all 30(100%) students recommend this method of structured consent taking for enhancement of communications skills. However 20% of the students were not satisfied with the teaching learning method expressing the need for more time allocation and demonstrations. Informed consent taking requires the appropriate training in the undergraduate period itself as seen by the improved OSCE scores on assessment after teaching by the structured consent taking process as well as from the feedback of the students.

ACR–ARS Practice Parameter on Informed Consent Radiation Oncology
Original Article
Hurwitz, Mark D., Chundury, Anupama, Goodman, Chelain R., Jones, Joshua, Lo, Simon S., Saeed, Hina, Small, William Jr, Schechter, Naomi R.
American Journal of Clinical Oncology, 8 March 2023
Abstract
Objectives
Consent is a communication process between the patient and a health care provider, in which both parties have the opportunity to ask questions and exchange information relevant to the patient’s diagnosis and treatment. The process of informed consent is designed to protect a patient’s autonomy in their medical decision-making in the context of an asymmetric relationship with the health care system. A proper consent process assures a patient’s individual autonomy, reduces the opportunity for abusive conduct or conflicts of interest, and raises trust levels among participants. This document was developed as an educational tool to facilitate these goals.
Methods
This practice parameter was produced according to the process described under the heading “The Process for Developing ACR Practice Parameters and Technical Standards” on the ACR website (https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards) by the Committee on Practice Parameters—Radiation Oncology of the ACR Commission on Radiation Oncology in collaboration with the ARS. Committee members were charged with reviewing the prior version of the informed consent practice parameter published in 2017 and recommending additions, modifications, or deletions. The committee met through remote access and subsequently through an online exchange to facilitate the development of the revised document. Focus was given on identifying new considerations and challenges with informed consent given the evolution of the practice of radiation oncology in part driven by the COVID-19 pandemic and other external factors.
Results
A review of the practice parameter published in 2017 confirmed the ongoing relevance of recommendations made at that time. In addition, the evolution of the practice of radiation oncology since the publication of the prior document resulted in the need for new topics to be addressed. These topics include remote consent either through telehealth or telephone and with the patient or their health care proxy.
Conclusions
Informed consent is an essential process in the care of radiation oncology patients. This practice parameter serves as an educational tool designed to assist practitioners in optimizing this process for the benefit of all involved parties.