Perception and confidence of medical students in informed consent: A core EPA
Tiffany N. Anderson, Lauren R. Aalami, Edmund W. Lee, Sylvia Bereknyei Merrell, Michael D. Sgroi, Dana T. Lin, James N. Lau
Surgery, 24 December 2019
Abstract
Background
Informed consent discussions have been identified as a core entrustable professional activity for medical students by the Association of American Medical Colleges. Medical students, however, rarely receive formal instruction on how to appropriately conduct informed consent discussions before residency, resulting in inconsistent levels of experience and deficiencies in performance. This study explores medical students’ understanding of the elements of informed consent discussions and their readiness to perform a comprehensive informed consent discussion.
Methods
Using expert consensus, cognitive interviews, and piloting, we iteratively developed a 15-item survey aligned with entrustable professional activity guidelines concerning informed consent discussions consisting of multiple choice, free text, and 5-point Likert-type questions. The instrument covered domains of experience, confidence, medical-legal knowledge, and recall of informed consent discussion elements. The full survey was distributed anonymously to undergraduate medical students at our institution. An abbreviated survey was administered to postgraduate students who were new interns at our institution. Responses were analyzed quantitatively using descriptive statistics. The free text data were coded for inclusion in this analysis.
Results
A total of 75 undergraduate medical students across all years responded (response rate [RR] = 86%), and 34 (RR = 77%) of the postgraduate students who were new interns participated. A total of 45 (75%) undergraduate medical students reported no training on informed consent discussions, and 9 (15%) undergraduate medical students had never witnessed an informed consent discussion. The undergraduate medical students agreed that informed consent discussions could be legally performed by residents and advance practice providers but were unsure whether the same applied to medical students. On a 5-point scale (anchored to “Not at all,” “Somewhat,” and “Extremely”), they were “somewhat confident” in their ability to perform an informed consent discussion. When asked to list the 7 elements of an informed consent discussion, 2 undergraduate medical students (3%) were able to identify all the elements. Although 3 undergraduate medical students (9%) had experience leading an informed consent discussion and 11 (32%) reported formal instruction in informed consent, the ability (3.7 ± 0.9 standard deviation [SD]) of the postgraduate students who were new interns to recall the 7 elements was similar to that of the undergraduate medical students (3.4 ± 1.2 SD); P = .31.
Conclusion
These findings suggest that undergraduate medical students and postgraduate students who are new interns are not confident or competent in their ability to perform an appropriate informed consent discussion. Our study findings support the creation of a needs-based, entrustable professional activity–aligned informed consent discussion teaching program and the need for an ongoing evaluation of the success of such a program.

Association Between the Communication Skills of Physicians and the Signing of Do-Not-Resuscitate Consent for Terminally Ill Patients in Emergency Rooms (Cross-Sectional Study)          
Original Research
Chih-Hung Chen, Ya-Hui Cheng, Fen-Ju Chen, Eng-Yen Huang, Po-Ming Liu, Chia-Te Kung, Chao-Hui Su, Shu-Hwa Chen, Peng-Chen Chien, Ching-Hua Hsieh
Risk Management and Healthcare Policy, 11 December 2019; 12 pp 307—315
Abstract
Background
The signing of do-not-resuscitate (DNR) consent is mandatory in providing a palliative approach in the end-of-life care for the terminally ill patients and requires an effective communication between the physician and the patients or their family members. This study aimed to investigate the association between the communication skills of physicians who participated in the SHARE (supportive environment, how to deliver the bad news, additional information, reassurance, and emotional support) model course on the patient notification and the signing of do-not-resuscitate (DNR) consent by the terminally ill patients at emergency rooms.
Methods
Between May 1, 2017 and April 30, 2018, a total of 109 terminally ill patients were enrolled in this study, of which 70 had signed a DNR and 39 had not. Data regarding the patients’ medical records, a questionnaire survey completed by family members, and patient observation forms were used for the assessment of physicians’ communication skills during patient notification. The observation form was designed based on the SHARE model. A multivariate logistic regression model was applied to identify the independent significant factors of the patient and family member variables as well as the four main components of the observation form.
Results
The results revealed that knowing how to convey bad news and providing reassurance and emotional support were significantly correlated with a higher rate of signing DNR consent. Additionally, physician-initiated discussion with family members and a predicted limited life expectancy were negative independent significant factors for signing DNR consent.
Conclusion
This study revealed that good communication skills help to increase the signing of DNR consent. The learning of such skills from attendance of the SHARE model course is encouraged for the physicians in the palliative care of terminally ill patients in an emergency room.

Informed consent for anaesthesia: Presential or non-presential information?
Faura A, Izquierdo E, Escriche L, Nogué G, Videla S
Journal of Healthcare Quality Research, 21 Nov 2019
Abstract
Introduction
The anaesthesia informed consent (AIC) is a process of communication between a clinician and a patient that results in the patient agreeing to undergo a specific anaesthetic procedure after understanding all the information needed to make a free, voluntary and conscious decision. This information is traditionally given during a face-to-face pre-operative visit.
Objective
To evaluate patient perceptions when they receive the information about AIC, face-to-face or by phone.
Patients and Methods
A single centre, randomised, double-blind, parallel-group pilot clinical trial was conducted on patients > 18 years of age undergoing major ambulatory surgery procedures with a surgical complexity that did not require a face-to-face pre-operative visit. Patients were randomly assigned to be informed by telephone (experimental group) or in a face-to-face visit (control group). Fifteen days after the surgery a questionnaire was used to gather patient perceptions in understanding the anaesthetic procedure and risks, autonomy (to ask for explanations), as well as and satisfaction.
Results
Of the 160 patients that gave their consent, 142 were interviewed: 70 from the experimental group and 72 from the control group. Both groups were comparable in age, gender, anaesthetic risk, and surgical complexity. The percentage of patients that understood the information provided on the anaesthetic technique was 71% and 81%, respectively (P=.429); on its risks: 67% and 69% (P=.951); autonomy: 56% and 74% (P=.036) and satisfaction rate: 46% and 46% (P=.835).
Conclusion
There is no difference between the groups in the level of understanding of the information that the patient perceives and the level of satisfaction. Nevertheless, almost half of them did not remember to have been given the possibility to clear-up doubts.

Compassionate and Clinical Behavior of Residents in a Simulated Informed Consent Encounter
Waisel DB, Ruben MA, Blanch-Hartigan D, Hall JA, Meyer EC, Blum RH
Anesthesiology, 20 November 2019
Abstract 
What We Know About This Topic
Compassionate behavior in clinicians includes understanding patients’ psychosocial, physical, and medical needs; promptly attending to needs; and engaging patients to the extent they wish.
What This Article Will Tell Us That Is New
The investigators evaluated compassionate behavior of anesthesia residents in a simulated preoperative encounter with a patient in pain before urgent surgery. Anesthesia residents had variable and, at times, flawed recognition of patient cues, responsiveness to patient cues, pain management, and patient interactions.
Background
Compassionate behavior in clinicians is described as seeking to understand patients’ psychosocial, physical and medical needs, timely attending to these needs, and involving patients as they desire. The goal of our study was to evaluate compassionate behavior in patient interactions, pain management, and the informed consent process of anesthesia residents in a simulated preoperative evaluation of a patient in pain scheduled for urgent surgery.
Methods
Forty-nine Clinical Anesthesia residents in year 1 and 16 Clinical Anesthesia residents in year 3 from three residency programs individually obtained informed consent for anesthesia for an urgent laparotomy from a standardized patient complaining of pain. Encounters were assessed for ordering pain medication, for patient-resident interactions by using the Empathic Communication Coding System to code responses to pain and nausea cues, and for the content of the informed consent discussion.
Results
Of the 65 residents, 56 (86%) ordered pain medication, at an average of 4.2 min (95% CI, 3.2 to 5.1) into the encounter; 9 (14%) did not order pain medication. Resident responses to the cues averaged between perfunctory recognition and implicit recognition (mean, 1.7 [95% CI, 1.6 to 1.9]) in the 0 (less empathic) to 6 (more empathic) system. Responses were lower for residents who did not order pain medication (mean, 1.2 [95% CI, 0.8 to 1.6]) and similar for those who ordered medication before informed consent signing (mean, 1.9 [95% CI, 1.6 to 2.1]) and after signing (mean, 1.9 [95% CI, 1.6 to 2.0]; F (2, 62) = 4.21; P = 0.019; partial η = 0.120). There were significant differences between residents who ordered pain medication before informed consent and those who did not order pain medication and between residents who ordered pain medication after informed consent signing and those who did not.
Conclusion
In a simulated preoperative evaluation, anesthesia residents have variable and, at times, flawed recognition of patient cues, responsiveness to patient cues, pain management, and patient interactions.

Acting In Good Faith: Operating Without Truly Informed Consent
Jeffrey G. Gaca
The Annals of Thoracic Surgery, December 2019; 108(6) pp 1613-1614
Abstract
Patients who undergo cardiac surgical procedures represent the full spectrum of society, from those who obsessively research, investigate, and query the treating physicians prior to an operation to those who want to hear nothing at all about an upcoming procedure. This latter group of patients often will say, “Doc, I trust you, just do what you think is right.” The key question in this scenario1 is should the surgeon proceed with mitral valve repair without truly informed consent? Informed consent comprises several important fundamental elements, including (1) competence, (2) disclosure, and (3) voluntariness.

Improving Consent Documentation in the Medical Intensive Care Unit
Original Article
Armin Krvavac, Pujan H. Patel, Ghassan Kamel, Zeyu Hu, Nirav Patel
Curesus, 17 November 2019; 11(11)
Open Access
Abstract
The contemporary patient-centered medical practice relies upon the acquisition of informed consent, which serves as written proof that the patient has recognized and agreed to the risks and benefits of their treatment. Well-documented informed consent forms are not only reflective of important ethical practices in medicine but can also serve as legal documents to protect healthcare providers from undue liabilities. We conducted a quality improvement project with the intention to improve the accuracy and completeness of consent form documentation in the medical intensive care unit.

The evaluation of consent forms before our intervention revealed that only 6.8% were correctly completed, with an average of 10.2 out of 14 (73%) essential items correct. Our intervention involved a multifaceted approach that included targeted education in combination with process improvement. The post-intervention results at one month revealed improvement in consent form accuracy from 6.8% to 60% (p = 0.0001), with an increase in the average number of essential items documented correctly from 10.2 to 13.5 (p = 0.0001). Data were collected three months post-intervention to evaluate for sustained improvement. Results revealed a significant decrease in consent form accuracy to 39% when compared to the one-month post-intervention data but still maintained a statistically significant improvement when compared to initial baseline data; 6.8% to 39% (p = <0.01).

Following the intervention, overall consent form accuracy improved significantly at our institution. Furthermore, these positive adjustments persisted when assessed at three months post-intervention despite the decrease as compared to one-month post-intervention. This trend suggests that our multifaceted intervention was able to increase the quality and accuracy of consent form documentation successfully.

Informed consent in obstetrics: a survey of pregnant women to set a new standard in informed consent for emergency obstetric interventions [POSTER]
Tracey Sturgeon, Huma Ayaz, Kirsty McCrorie, Kate Stewart
BMJ Leader, 3 November 2019; 3(A9)
Open Access
Abstract
Respect for autonomy supports the rights of women to make their own decisions about care as laid out by the Supreme Court ruling on Montgomery (2015). Consent for emergency procedures in obstetrics presents a significant challenge. Consent obtained when a woman is exhausted, influenced by endogenous or exogenous chemicals or in fear of her unborn child’s safety cannot be considered to be informed. An opportunistic survey of pregnant women in Highland region was conducted over 6 weeks in community and secondary care antenatal clinics. Primary objective-determine women’s current understanding of emergency obstetric interventions in labour to guide our work in achieving informed consent. Secondary objective-compare regional and Scottish national delivery data to allow realistic counseling of women regarding possibility of such interventions. Results were analysed and comments qualitatively explored. Labour and delivery expectations of survey participants were compared to regional and Scottish national delivery data (2018). We found that many women were uncertain regarding possibility of intervention. Both prim and parous women requested more information; some specifically asked for up-to-date statistics. Regional and Scottish national delivery intervention rates were comparable. Current intervention rates (by regional and Scottish national data) are significantly higher than expected. Our data is in keeping with Scottish data so this is likely an issue in other regions too. Our survey showed pregnant women may not have realistic expectations of delivery outcomes. Pregnant women need information based on regional and national data to foster realistic expectations of labour or delivery; empowering decision-making and ensuring peri-partum emergency consent is still informed consent. A multi-disciplinary approach to a novel means of obtaining informed consent will allow NHS Highland to lead the way in implementing change to improve the care of our pregnant women.

Interventions to Improve Informed Consent: Perhaps Surgeons Should Speak Less and Listen More
Invited Commentary
Peter Angelos
JAMA Surgery, 30 October 2019
Exceprt
High-quality informed consent is central to the ethical practice of surgery. In this issue of JAMA Surgery, Schwarze and colleagues report on a novel attempt to increase patient engagement and well-being by sending older surgical patients a question prompt list (QPL) before their visit with a surgeon. For older patients undergoing high-risk operations, the authors have appropriately pointed out that the surgical procedure is often the start of a lengthy hospitalization and subsequent substantial changes in their ability to live independently or return to preoperative health status. They sought to improve the informed consent process for this group of vulnerable patients by working with surgeons to develop an informational brochure with a list of 11 questions to prompt patients and family members to ask their surgeons about treatment options, expectations for recovery, and management of potential serious complications…

Infringement of the right to surgical informed consent: negligent disclosure and its impact on patient trust in surgeons at public general hospitals – the voice of the patient
Research Article
Gillie Gabay, Yaarit Bokek-Cohen
BMC Medical Ethics, 28 October 2019; 20(77)
Open Access
Abstract
Background
There is little dispute that the ideal moral standard for surgical informed consent calls for surgeons to carry out a disclosure dialogue with patients before they sign the informed consent form. This narrative study is the first to link patient experiences regarding the disclosure dialogue with patient-surgeon trust, central to effective recuperation and higher adherence.
Methods
Informants were 12 Israelis (6 men and 6 women), aged 29–81, who underwent life-saving surgeries. A snowball sampling was used to locate participants in their initial recovery process upon discharge.
Results
Our empirical evidence indicates an infringement of patients’ right to receive an adequate disclosure dialogue that respects their autonomy. More than half of the participants signed the informed consent form with no disclosure dialogue, and thus felt anxious, deceived and lost their trust in surgeons. Surgeons nullified the meaning of informed consent rather than promoted participants’ moral agency and dignity.
Discussion
Similarity among jarring experiences of participants led us to contend that the conduct of nullifying surgical informed consent does not stem solely from constraints of time and resources, but may reflect an underlying paradox preserving this conduct and leading to objectification of patients and persisting in paternalism. We propose a multi-phase data-driven model for informed consent that attends to patients needs and facilitates patient trust in surgeons.
Conclusions
Patient experiences attest to the infringement of a patient’s right to respect for autonomy. In order to meet the prima facie right of respect for autonomy, moral agency and dignity, physicians ought to respect patient’s needs. It is now time to renew efforts to avoid negligent disclosure and implement a patient-centered model of informed consent.