A New Layer of Informed Consent: Discussions and Documentation Regarding Sensitive Examinations in Surgery
Surgical Perspectives
Lauren R. Wilson, Courtney Tanner, Sandra L. Wong
Annals of Surgery, March 2022; 3(1)
Mini-Abstract
A growing number of states have statutes regulating the performance of sensitive examinations on anesthetized patients. The scope of the examinations covered includes breast, pelvic, prostate, and rectal examinations, increasing the impact of these laws on surgeons. There is a broadening focus on obtaining consent for any provider and learner performing these examinations.

American Society for Gastrointestinal Endoscopy guideline on informed consent for GI endoscopic procedures
Guideline
ASGE Standards of Practice Committee, Andrew C. Storm, Douglas S. Fishman, James L. Buxbaum, Nayantara Coelho-Prabhu, Mohammad A. Al-Haddad, Stuart K. Amateau, Audrey H. Calderwood, Christopher J. DiMaio, Sherif E. Elhanafi, Nauzer Forbes, Larissa L. Fujii-Lau, Terry L. Jue, Divyanshoo R. Kohli, Richard S. Kwon, Joanna K. Law, Swati Pawa, Nirav C. Thosani, Sachin Wani, Bashar J. Qumseya
Gastrointestinal Endoscopy, February 2022; 95(2) pp 207-215
Abstract
Informed consent is the cornerstone of the ethical practice of procedures and treatments in medicine. The purpose of this document from the American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee is to provide an update on best practice of the informed consent process and other issues around informed consent and shared decision-making for endoscopic procedures. The principles of informed consent are based on longstanding legal doctrine. Several new concepts and clinical trials addressing the best practice of informed consent will help guide practitioners of the burgeoning field of GI endoscopic procedures. After a literature review and an iterative discussion and voting process by the ASGE Standards of Practice Committee, this document was produced to update our guidance on informed consent for the practicing endoscopist. Because this document was designed by considering the laws and broad practice of endoscopy in the United States, legal requirements may differ by state and region, and it is the responsibility of the endoscopist, practice managers, and other healthcare organizations to be aware of local laws. Our recommendations are designed to improve the informed consent experience for both physicians and patients as they work together to diagnose and treat GI diseases with endoscopy.

Digital Online Anaesthesia Patient Informed Consent before Elective Diagnostic Procedures or Surgery: Recent Practice in Children—An Exploratory ESAIC Survey (2021)
Claudia Neumann, Grigorij Schleifer, Nadine Strassberger-Nerschbach, Johannes Kamp, Gregor Massoth, Alexandra Görtzen-Patin, Dishalen Cudian, Markus Velten, Mark Coburn, Ehrenfried Schindler, Maria Wittmann
Journal of Clinical Medicine, 19 January 2022
Open Access
Abstract
Background
One undisputed benefit of digital support is the possibility of contact reduction, which has become particularly important in the context of the COVID-19 pandemic. However, to the best of our knowledge, there is currently no study assessing the Europe-wide use of digital online pre-operative patient information or evaluation in the health sector. The aim of this study was to give an overview of the current status in Europe.
Methods
A web-based questionnaire covering the informed consent process was sent to members of the European Society of Anaesthesia and Intensive Care Medicine (ESAIC) in 47 European countries (42,433 recipients/930 responses). Six questions related specifically to the practice in paediatrics.
Results
A total of 70.2% of the respondents indicated that it was not possible to obtain informed consent via the Internet in a routine setting, and 67.3% expressed that they did not know whether it is in line with the legal regulations. In paediatric anaesthesia, the informed consent of only one parent was reported to be sufficient by 77.6% of the respondents for simple interventions and by 63.8% for complex interventions. Just over 50% of the respondents judged that proof of identity of the parents was necessary, but only 29.9% stated that they ask for it in clinical routine. In the current situation, 77.9% would favour informed consent in person, whereas 60.2% could imagine using online or telephone interviews as an alternative to a face-to-face meeting if regulations were changed. Only 18.7% participants reported a change in the regulations due to the current pandemic situation.
Conclusion
Whether informed consent is obtained either online or on the telephone in the paediatric population varies widely across Europe and is not currently implemented as standard practice. For high-risk patients, such as the specific cohort of children with congenital heart defects, wider use of telemedicine might provide a benefit in the future in terms of reduced contact and reduced exposure to health risks through additional hospital stays.

Symptomatic Features and Factors Associated With Do-Not-Resuscitate Consent in Advanced Cancer Patients Admitted to Palliative Care Ward
Research Article
Rongrong Fan, Siyu Yang, Xiaofan Bu, Yongyi Chen, Ying Wang, Boyong Shen, Cuiling Qiu, Xuying Li
American Journal of Hospice and Palliative Medicine, 18 January 2022
Abstract
This study aimed to conduct a retrospective cross-sectional study to investigate the prevalence of symptoms and symptom clusters on sociodemographic and disease characteristics, as well as factors associated with Do-Not-Resuscitate (DNR) consent. Advanced cancer patients were enrolled between 2018 and 2020 with available data. Demographic and clinical data were obtained for analysis from Hospital Information System (HIS) in China. Symptom clusters were extracted by hierarchical cluster analysis. Chi-square test and multiple logistic regression were conducted to investigate the prevalence characteristics of symptoms and influencing factors of DNR consent, respectively. 798 advanced cancer patients were enrolled. The most prevalent symptoms were pain (93%), anorexia (36.5%), and sleep disorders (34.2%). High heart rate was associated with poor performance status and more symptoms. Three clusters were extracted: fatigue-related, respiratory-circulatory system, and digestive system symptom clusters. The incidence of symptoms was statistically significant in age, gender, education level, residence, BMI, performance status, distress score, ADL, and primary pain level. The DNR signature rate was 15.5%. Female, distant metastasis, in-ward rescue, and appearance of dyspnea were independent influencing factors of DNR signature…

Toward Personalized Informed Consent in Cancer Care
Editorial
Anne Lanceley
Medical Anthropology, 18 January 2022
Excerpt
…As the articles in this volume show, people with cancer may experience profound emotional distress, bewilderment, and loss and are often challenged to engage in life while living with symptomatic disease and closeness to death. This circumstance may dramatically alter support needs and personal relationships, threaten psychological well-being, and present challenges for patients and families to say and navigate a complex health care system. The papers present different facets of the profound uncertainty and unpredictability that characterizes twenty-first-century cancer care for patients and clinicians. To me the articles reflect patients’ and health care professionals’ struggle with the risk calculus involved in consenting to treatments where outcomes are unproven, a struggle that has recently been embellished by the uncertainty of COVID-19…

Medical Student Attitudes on Explicit Informed Consent for Pelvic Exams Under Anesthesia
Original Reports
Benjamin E Zuchelkowski, Soukaina Eljamri, Jill E McDonnell, Bhavya Varma, Natalie G Stern, Scott D Rothenberger, Kavita Shah Arora, Judy C Chang
Journal of Surgical Education, 17 January 2022
Abstract
Objective
To obtain an overview of medical student attitudes on the need for explicit consent for pelvic exams under anesthesia performed for educational purposes
Design
From February to October 2020, 201 medical students at a single medical school in the United States participated in a cross-sectional survey after completion of the obstetrics and gynecology clerkship. Outcome measures included endorsement of need for explicit informed consent for educational pelvic exams under anesthesia, and knowledge of informed consent processes for such exams.
Setting
University of Pittsburgh School of Medicine
Participants
Third- and fourth-year medical students
Results
Overall, 75% of medical students endorsed a need for explicit informed consent for educational pelvic exams under anesthesia, which extended to prostate, rectal, and breast exams under anesthesia. Additionally, 45% and 77% of these participants indicated that consent for educational pelvic exams under anesthesia should take the form of a separate signature line on the surgical consent form and/or a verbal form, respectively. Only 40% of students correctly identified institutional policy for obtaining informed consent for educational pelvic exams under anesthesia. Rotation with the oncologic surgical service (p = 0.02) and correct identification of institutional informed consent policies (p = 0.002) were associated with decreased perceptions of the importance of explicit informed consent for educational pelvic exams under anesthesia.
Conclusions
Medical students at the institution studied largely support explicit informed consent for educational pelvic and other sensitive exams under anesthesia, but a knowledge gap on institutional informed consent policy exists. Medical students support increased transparency and bodily autonomy. Due to the agreement of patients and medical students and the ethical rationale for this position, it may be appropriate for physicians and institutions to consider new processes of obtaining explicit informed consent for pelvic exams under anesthesia by medical students.

Variation in the interpretation and application of the Medicaid sterilization consent form among Medicaid officials
Original Research Article
Colin B. Russell, Neena Qasba, Megan L. Evans, Angela Frankel, Kavita Shah Arora
Contraception, 14 January 2022
Abstract
Objective(s)
The Medicaid consent policy has been identified as a major barrier to desired permanent contraception, particularly for low-income communities and communities of color. As each state may modify their state Medicaid sterilization consent form, variation in the form has been reported. This study aims to characterize state-level variation in Medicaid Title XIX consent form interpretation and application.
Study Design
We aimed to collect primary data from Medicaid officials in all 50 United States from January to May 2020 via a 25-question electronic survey regarding state-level consent form implementation. Questions targeted consent form details and definitions, insurance and billing, clinician correspondence, and administrative processes. We used Qualtrics XM® to collect survey responses. We performed descriptive statistics on the survey responses. There were no exclusion criteria.
Results
We had 41 responses from 36/50 states (72% participation rate). Heterogeneity existed in the key definitions of “Premature Delivery” and “Emergency Abdominal Surgery.” One in five respondents reported the consent form was only available in English. Variation among Current Procedural Terminology codes covered in each state’s sterilization policy were noted. Nearly a quarter of respondents did not know how Medicaid informed healthcare providers of consent form denials. Most participants (90%) were unaware of differences between state sterilization policies.
Conclusion
This study demonstrates variation in terms of consent form definitions, procedures covered, correspondence with clinicians, and administrative review processes among state Medicaid offices regarding the sterilization consent form. Greater transparency is necessary in order to reduce administrative barriers to desired permanent contraception.

Consent Issues in the Management of Acute Ischemic Stroke
AAN Position Statement
Justin A. Sattin, Winston Chiong, Richard J. Bonnie, Matthew P. Kirschen, James A. Russell
Neurology, 11 January 2022; 98(2)
Abstract
This position statement briefly reviews the principle of informed consent, the elements of decisional capacity, and how acute stroke may affect this capacity. It further reviews the role of surrogate decision-making, including advance directives, next of kin, physician orders for life-sustaining treatment, and guardianship. In some cases of acute stroke in which the patient lacks decisional capacity and no advance directives or surrogates are available, consent to treatment may be presumed. The document describes the rationale for this position and various considerations regarding its application to IV thrombolysis, neuroendovascular intervention, decompressive craniectomy, and pediatric stroke. The document also reviews consent issues in acute stroke research.

Procedural-based Specialties Benefit from a Formal Informed Consent and Disclosures Educational Program
Original Reports
Valeda Yong, Huaqing Zhao, Kimberly Gilmore, Jane Cripe, Charles Conklin, Elizabeth Dauer
Journal of Surgical Education, 6 January 2022
Abstract
Objective
At our tertiary academic center, residents undergo formalized training in obtaining informed consent and disclosing a complication. The informed consent portion has previously been shown to benefit a group of surgical and emergency medicine residents. We aimed to determine if the benefits from training persist across a larger number of procedural-based specialties and to ascertain the benefit of training in disclosing complications.
Design
This retrospective cohort study examined first-year residents from seven procedural-based specialties who participated in a formal informed consent and disclosures training program, consisting of a didactic lecture and two-part simulation. Two years after the start of the program, the disclosure scenario was added. Participants were given pre- and post-surveys assessing comfort and confidence in the informed consent and disclosure scenarios. Survey results were compared using the signed-rank test and Kruskal-Wallis test as appropriate.
Setting
This study occurred at Temple University Hospital, a tertiary academic institution in Philadelphia, PA.
Participants
First-year residents from 2014 to 2020 in seven procedural-based specialties, including general surgery, orthopedic surgery, otolaryngology, obstetrics and gynecology, emergency medicine, radiology, and anesthesia, participated in this study. One hundred and ninety-three residents completed the program and surveys.
Results
Residents reported improved confidence in filling out an informed consent form (p = 0.036) and more comfortable in obtaining informed consent (p = 0.041), as well as more confidence (p = 0.018) and comfort (p = 0.001) in disclosing a complication. Surgical residents demonstrated greater confidence in obtaining informed consent (p = 0.009) and disclosing a complication (p = 0.0002) after training than non-surgical residents.
Conclusions
Across multiple procedural-based specialties, formal training in informed consent and disclosure of complications increases resident ability to perform these tasks. A formal training program is valuable for residents who are expected to perform these tasks across various specialties.