Effective Informed Consent Communication Skills for Senior Medical Students (Sub-Interns)
Katharine A. Robb, Hanna D. Zembrzuska, Marcy Rosenbaum
Patient Education and Counseling, April 2023
Abstract
Background
Obtaining informed consent from patients for procedural tests/treatments is an important communication task for health care providers, involving more than just getting a consent form signed. To ensure that patients have understanding to make informed decisions, effective communication skills are needed in conducting informed consent conversations. Several studies have demonstrated that new postgraduate learners (interns) lack skills to conduct these conversations effectively. Sub-internship rotations aimed at preparing senior medical students for their upcoming role as postgraduate trainees may be an appropriate place to introduce learners to informed consent skills.
Methods
We developed an educational intervention on effective informed consent communication skills for sub-interns in Internal Medicine. Educational components included: 1) A pre-workshop self-study module on blood transfusion and joint aspiration; 2) A two-hour experiential workshop on Zoom (or in person) where students learn about and practice effective informed consent conversation communication skills on the two procedures. Each student engages in a consent conversation (7-10 minutes) with a simulated patient while the other students watch, followed by debriefing and learner feedback. Two versions of each case are enacted (“easy” versus “apprehensive” patient) demonstrating how to apply the skills to patients with different reactions and concerns.
Assessment/evaluation
Pre-intervention assessments indicating the need for this session included data from entering intern OSCEs (N=33 over 3 years) in which interns scored lowest on the informed consent station and a needs assessment survey revealing sub-interns (N=24) desired formal training in informed consent skills. A post-intervention evaluation survey revealed all participating sub-interns found being able to practice, receive feedback and observe others practice was helpful in enhancing their informed consent skills. A pre-post retrospective survey will collect evaluation data from subsequent sessions.
Discussion
Time efficient experiential informed consent sessions are feasible to help better prepare senior learners for these important conversations and shared decision making.
Month: April 2023
Personalized surgical informed consent with stereoscopic visualization in neurosurgery—real benefit for the patient or unnecessary gimmick?
Personalized surgical informed consent with stereoscopic visualization in neurosurgery—real benefit for the patient or unnecessary gimmick?
Original Article – Neurosurgery general
Nicolas Hertzsprung, Kiril Krantchev, Thomas Picht, Anna L. Roethe, Kerstin Rubarth, Josch Fuellhase, Peter Vajkoczy, Güliz Acker
Acta Neurochirurgica, 28 February 2023
Open Access
Abstract
Background
Informed consent of the patient prior to surgical procedures is obligatory. A good and informative communication improves patients’ understanding and confidence, thus may strengthen the patient-doctor relationship. The aim of our study was to investigate the usefulness of additional stereoscopic visualization of patient-specific imaging during informed consent conversation.
Methods
Patients scheduled for a brain tumor surgery were screened for this study prospectively. The primary exclusion criteria were cognitive or visual impairments. The participants were randomized into two groups. The first group underwent a conventional surgical informed consent performed by a neurosurgeon including a demonstration of the individual MRI on a 2D computer screen. The second group received an additional stereoscopic visualization of the same imaging to explain the pathology more in-depth. The patients were then asked to fill in a questionnaire after each part. This questionnaire was designed to assess the potential information gained from the patients with details on the anatomical location of the tumor as well as the surgical procedure and possible complications. Patients’ subjective impression about the informed consent was assessed using a 5-point Likert scale.
Results
A total of 27 patients were included in this study. After additional stereoscopic visualization, no significant increase in patient understanding was found for either objective criteria or subjective assessment. Participants’ anxiety was not increased by stereoscopic visualization. Overall, patients perceived stereoscopic imaging as helpful from a subjective perspective. Confidence in the department was high in both groups.
Conclusion
Stereoscopic visualization of MRI images within informed consent conversation did not improve the objective understanding of the patients in our series. Although no objective anatomical knowledge gain was noted in this series, patients felt that the addition of stereoscopic visualization improved their overall understanding. It therefore potentially increases patient confidence in treatment decisions.
Legally Effective but Ethically Inadequate: Institutional Review Board Policies for Consent from Legally Authorized Representatives
Legally Effective but Ethically Inadequate: Institutional Review Board Policies for Consent from Legally Authorized Representatives
Robert R. Harrison
Ethics & Human Research, 27 March 2023
Abstract
The prevailing approach to enrolling decisionally impaired adults in clinical research is to rely on permission from a default surrogate, one identified by law rather than by the prospective research participant. Reliance on a surrogate transfers the focus of ethical protection from a researcher-participant relationship to a researcher-surrogate relationship; the selection and role of the surrogate are therefore important. The Common Rule defers to state law governing default surrogate consent to research, but most states have no such law; for those states, the Common Rule defers to institutional policy. I reviewed twenty-five of the study sites with the highest National Institutes of Health funding levels to elaborate the content of institutional review board (IRB) policies and compare those to a suggested paradigm for ethically defensible policies. My findings suggest that IRB policies provide inadequate protection because they recognize surrogates who lack knowledge of the subject’s current values and preferences without imposing adequate additional safeguards.
Minor Consent Laws for Sexually Transmitted Infection and Human Immunodeficiency Virus Services in the United States: A Comprehensive, Longitudinal Survey of US State Laws
Minor Consent Laws for Sexually Transmitted Infection and Human Immunodeficiency Virus Services in the United States: A Comprehensive, Longitudinal Survey of US State Laws
Kimberly M. Nelson, Alexandra Skinner, Claire D. Stout, Will Raderman, Emily Unger, Julia Raifman, Madina Agénor, Michele L. Ybarra, Shira I. Dunsiger, S. Bryn Austin, Kristen Underhill
American Journal of Public Health, 8 March 2023
Abstract
Objectives
To assess changes in minor consent laws for sexually transmitted infection (STI) and HIV testing, treatment, and prevention services in all 50 US states and the District of Columbia from 1900 to 2021.
Methods
We coded laws into minor consent for (1) health care generally; (2) STI testing, treatment, and prevention; (3) HIV testing, treatment, and prevention; and (4) pre- or postexposure prophylaxis for HIV prevention. We also coded confidentiality protections and required conditions (e.g., threshold clinician judgments).
Results
The largest increase in states allowing minors to consent to STI services occurred during the 1960s and 1970s. By 2021, minors could consent independently to STI and HIV testing and treatment in all 50 states plus DC, STI prevention services in 32 jurisdictions, and HIV prevention services in 33 jurisdictions. Confidentiality protections for minors are rare. Prerequisites are common.
Conclusions
Although the number of states allowing minors to consent independently to STI and HIV services has increased considerably, these laws have substantial limitations, including high complexity, prerequisites requiring clinician judgments, and neglect of confidentiality concerns.
Waivers of informed consent in research with competent participants and the Declaration of Helsinki
Waivers of informed consent in research with competent participants and the Declaration of Helsinki
Perspective
Rafael Dal-Ré
European Journal of Clinical Pharmacology, 8 March 2023
Open Access
Excerpt
The World Medical Association started revisions to the Declaration of Helsinki in 2022 and it will have to address numerous issues that have arisen in research ethics since the last 2013 revision [1]. In the face of critical issues that have surfaced during the COVID-19 pandemic, less salient but nevertheless critically important issues may go unnoticed. One of these concerns is the conditions under which it is ethically permissible to modify or waive written informed consent in research with competent participants…
Guidance Paper 2: Obtaining Consent in Research involving Children – Understanding the Legal and Ethical Framework
Guidance Paper 2: Obtaining Consent in Research involving Children – Understanding the Legal and Ethical Framework
National Centre for Research Methods, 2023
Open Access
Excerpt
This guidance paper describes the importance of obtaining consent from and on behalf of child participants involved in research. It is Guidance Paper 2 in the series The Ethics of Research Involving Children: Common Questions, Potential Strategies and Useful Guidance. Ethical research considers the international and domestic law, as well as ethical and professional, obligations towards ensuring that participants provide valid consent. Issues around consent are paramount in research ethics applications. The law and ethics of consent are not just about ensuring that the child is fully aware of the implications of his or her involvement in the research and is kept safe (which might necessitate obtaining consent also from adults with parental responsibility); it is equally about ensuring that overly paternalistic approaches to consent are avoided, as such approaches may unintentionally undermine children’s autonomy and prevent children from making decisions and expressing themselves on their own terms. As the ESRC notes in its ethical guidance: “Researchers should consider the ethics implications of silencing and excluding children from research.” Beazley et al. (2009: 370) refer to this as children’s right to be ‘properly researched’ which ‘translates into: children being participants in research; using methods that make it easy for them to express their opinions, views and experiences; and being protected from harm’…
Editor’s note: The national Centre for Research Methods delivers a programme of research methods training across the UK. The ESRC referenced stands for the Economic and Social Research Council in the UK.
A Multi-Institutional Informed Consent Proposal as a Prevention Tool for Combined Oral Contraceptive Intake and Thrombotic Risk
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
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
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
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.
Center for Informed Consent Integrity 