Informed Consent and Disclosure of Surgeon Experience
Sabha Ganai
Surgical Ethics, 27 March 2019; pp 217-229
Abstract
This chapter reviews ethical issues and legal precedent relevant to informed consent for surgical procedures using a shared decision-making framework. The process of informed consent is examined in a systematic fashion, including reviewing ways to improve doctor-patient communication and important considerations for documentation of the consent process. Disclosure of surgical experience will also be explored, including the complexities of dealing with statistics from surgeon-specific reports. Ethical principles including respect for patient autonomy, beneficence, and distributive justice and duty to tell the truth will be explored as relevant to the doctrine of informed consent.

The Surgical Informed Consent Process: Myth or Reality?
Miguel A. Caínzos, Salustiano Gonzalez-Vinagre
Surgical Ethics, 27 March 2019; pp 203-216
Abstract
Informed consent is currently considered to be a highly important factor which is becoming a critical component of surgical practice. It is a complex process and not just an event or a single encounter. In the twenty-first century, it is accepted that the traditional paternalist relationship between the patient and physician has been replaced by a new type of relationship in which the patient detents a very active and crucial role. For patients who need a surgical procedure, the informed consent process represents the honing of this link between the surgeon and his or her patient. The legal principle emphasizes the fact that the patient is an independent adult who has the capacity to authorize what is going to be done to his or her body. This is a process with significant ethical and legal aspects where both the surgeon and the patient play a major role.

The components which make up the informed consent process are the preconditions, the information provided to the patient, and the consent itself. The most complex step of the informed consent process for the surgeon is providing correct, truthful, unbiased, and accurate information to the patient while keeping hope in him or her. The physician disclosure has three stages: the disclosure of information, the patient understanding, and the patient decision-making. It is necessary to adapt the information to each patient in a language they can always understand. The physician must provide information about the surgical procedure, the benefits, the associated risks, potential complications, and alternative procedures, if any.

Surgeons must use all the available tools to adequately inform the patient and the relatives and improve his or her understanding: information leaflets, multimedia interventions, decision aids, the Internet, and government and professional organization guidelines. New tools as surgical risk calculators which estimate patient-specific postoperative complications for different procedures are now available.

The ultimate goal of the informed consent process should be fostering the patient’s trust in his or her surgeon.

Editor’s note: The ultimate goal of informed consent as stated here is the author’s view and does not represent the views of this digest.

Consent in the Exam Room
Jennifer Mendillo Keller
The Journal of Sexual Medicine, 26 March 2019
Introduction
Explicitly obtaining consent from a patient prior to starting a sensitive physical exam is essential to improve their experience with intimate examinations such as the genitourinary exam.
Aim
The purpose of this article is to raise awareness among providers about how and why to obtain consent for intimate examinations.
Methods
The current literature on consent was reviewed and the opinion piece was created using current events and literature.
Outcome measures
None.
Results
Providers have a responsibility to consent patients for a sensitive exam.
Conclusion
Explicitly obtaining consent from a patient prior to starting a sensitive physical exam such as a genitourinary exam is essential to improve the patient experience with such exams.

Perioperative Complications Chapter: Shared Decision-Making and Informed Consent
William K. Hart, Robert C. Macauley, Daniel A. Hansen, Mitchell H. Tsai
Catastrophic Perioperative Complications and Management, 20 March 2019; pp 397-406
Abstract
The practice of anesthesiology has grown remarkably safer, but complications ranging from minor to catastrophic may still occur. Improvements in patient safety have made surgery and anesthesia both commonplace and routine. The perioperative process, which classically began with admission to the hospital the night before the day of surgery, has been condensed into the efficient and increasingly cost-effective process of outpatient surgery. Patient confidence and comfort with this process has much to do with openness and communication on behalf of anesthesiologists and surgeons which did not always exist.

Informed consent acknowledges the patient’s individual autonomy and right to decide what medical or surgical interventions should be a part of his or her health care. A patient may elect to pursue a certain treatment when he or she is determined to have decision-making capacity; risks, benefits, and alternatives to the proposed treatment have been adequately disclosed; and the decision to pursue treatment is voluntary, or free of external coercion.

Shared decision-making builds on the foundation of informed consent. It broadens the discussion to include the patient’s goals of care, beliefs, and expectations in context with the physician’s expert recommendation and experience. While perhaps most essential in high-risk operations and medically complex patients, shared decision-making is becoming increasingly recognized as a valuable tool for all patients in the perioperative process. Benefits of shared decision-making include increased patient satisfaction, cost savings, and decreased litigation.

Many institutions across the country have implemented multidisciplinary care teams to evaluate complex patients preoperatively, guide the decision-making process, plan for both postoperative care and unanticipated outcomes, and establish advanced directives. Informed consent and shared decision-making coupled with evidence-based medicine are an increasingly essential aspect of the patient-centered perioperative process.

Informed consent practice for obstetric and gynaecologic procedures: A patients’ perspective from a developing country
Zeeshan MF, Yousufi Z, Khan D, Malik FR, Ashfaq F, Batool F, Atta L, Tariq H, Huma Z, Ghafoor R, Jamil A, Qazi U
Journal of Evaluation in Clinical Practice, 28 February 2019
Objectives
To assess the surgical informed consent (SIC) practices for obstetric and gynaecological (OB-GYN) procedures at different hospitals in Pakistan.
Methods
Study was conducted in five hospitals (three public and two private) of Peshawar, Pakistan. A pretested structured tablet-based questionnaire was administered from October 2016 through January 2017 among post-op OB-GYN patients.
Results
About 27% of the patients (significantly more in private hospitals, P = 0.001) did not remember a formal consent administration. Most patients (80%) felt they had no choice about signing the consent. About 65% (mostly in public as compared with private hospitals) mentioned that they would have signed it regardless of the specifics in it (P < 0.001). Patients had increased odds to recall consent if they felt empowered, odds ratio (OR) = 4.5; had an opportunity to ask questions, OR = 7.2; wanted more explanation, OR = 2.8; and had consent administered in their mother tongue, OR = 6.9.
Discussion
Patients’ recall of key elements of consent was low. The time spent with the patient for consenting was much shorter than recommended. The printed consent forms were mostly not available in patients’ mother tongue.
Conclusions
Consent practice for OB-GYN procedures was suboptimal in studied hospitals. Patients’ attitude toward informed consent practices largely reflected providers’ focus on obtaining a legally valid signed consent as opposed to administering a consent that empowers patients to make an informed decision in the absence of any external pressure.

Improving the Effectiveness of the Informed Consent Process in Elective Aesthetic Procedures [POSTER]
Hagopian, Chelsea Olivia; Ades, Teresa B.; Hagopian, Thomas Martin; Wolfswinkel, Erik; Stevens, Grant
Virginia Henderson Global Nursing e-Repository, 14 February 2019
Abstract
Informed consent is commonly reduced to a legal formality rather than upholding its ethical ideal of being a process of shared decision-making. We present a multiphase development process model for creating a patient decision aid prototype to replace the traditional informed consent documents for primary breast augmentation surgery.

Informed-Consent Taking Procedure for Elective Surgery in Gaza strip: Patient’s Satisfaction with Doctor’s Communication
Khamis Elessi, Mohammed Elifranji, Zuhdi Elifranji
Islamic University Gaza Journal of Natural Studies, 12 March 2017; 26(1) pp 18-29
Background
Widespread dissatisfaction and mistrust exists among patients in the Gaza Strip towards doctors. A sense of a lack of sufficient information regarding diagnosis, risks and benefits of interventions and subsequent management plans is present among patients. All of these areas are considered essential components in the surgical consent process. A gap between patients’ actual understanding and that perceived by doctors has been shown to exist in different settings.1 Unfortunately, no former study has been done on this topic in the GazaStrip.
Objectives
This study aims to assess the satisfaction of patients in Gaza with the information provided to them during the consent process prior to an invasive procedure and compare this to the current practice and attitudes of surgeons.
Methods
A five-section self-designed questionnaire was administered using convenience sampling to the first 60 patients and first 60 surgeons who met the selection criteria in the two hospitals in the Gaza Strip: Al-Shifa Hospital and the European Gaza Hospital.
Findings
Among the surgeons surveyed, 55% answered that informed consent should be obtained by doctors only, 3% thought that it can be obtained by nurses only, while 45% stipulated either doctors or nurses can obtain it. In total only 38% of those healthcare professionals taking the consent from the patient, actually performed the procedure. During consent procedures, 73% of surgeons reported providing written documents 30% drawings explaining the procedure, 3% giving videos or animations and 8% suggesting website links for more information. The survey of patients revealed that only 25% of surveyed surgeons identified themselves to their patients, and 12% asked for the patients’ signature without a complete discussion of the intervention. Around 35% of surgeons depended on verbal communication only. Surgeons identified barriers for best practice as time constraints, as well as lack of hospital policies and informational resources. However, 87% of surgeons believed that informed consent has an impact on patient wellbeing. A total of 90% of surveyed patients thought they received the right treatment and were satisfied. While 43% of patients prefer to travel overseas to get treatment, 77% of these because of a perceived lack of medical equipment and facilities.

Informed Consent for Neurosurgical Innovation [BOOK CHAPTER]
Faith C. Robertson, Tiit Mathiesen, Marike L. D. Broekman
Ethics of Innovation in Neurosurgery, 22 February 2019; pp 11-25
Abstract
While innovation in neurosurgery introduces novel medical devices, lifesaving therapies, and critical advancements in procedural care, it also presents ethical challenges regarding informed consent, particularly as innovative treatment options may provide better patient outcomes, but unprecedented surgical interventions may include unknown risk. The process of informed consent relies on appropriate provision of information to a competent patient in efforts to permit patient autonomy over healthcare decision-making without coercion. Importantly, informed consent is not isolated to a single conversation and document signing but is rather an ongoing process of communication throughout the trajectory of the patient’s care. However, neurosurgical patients are one of the most vulnerable populations, as those eligible for experimental procedures often have illnesses refractory to standard therapies, and alternative treatments may be limited. Furthermore, for disease processes affecting information processing or the ability to participate in high-level cognitive decision-making, an individual’s capacity to partake in informed consent may be hindered. At present, there is limited guidance for how neurosurgeons should approach the informed consent process for novel treatments, and there is controversy over the extent to which a surgeon should discuss the innovative nature of the procedure, the evidence or lack thereof, the associated or unknown risks and benefits, the operating surgeon’s learning curve with respect to experience with the procedure, and the alternative treatment options. This chapter summarizes the importance and difficulties of informed consent within neurosurgery, including patient capacity, content and format of discussion, and coercion—all key factors in the attainment of proper consent and the clinical decision process. We underscore the inherent complexity in balancing scientific evidence, clinical expertise, and patient and family preference when pursuing innovative neurosurgical treatments, in efforts to bring about discussion on improvements we can make within the field. Ultimately, this moral discourse is invaluable in creating a situation where investigators assume a responsibility of ensuring respect for persons, beneficence, and justice as we work to propel the field of neurosurgery forward.

Factors complicating the informed consent process for whole exome sequencing in neonatal and pediatic intensive care units
CJ Diamonstein
Journal of genetic counseling, 8 February 2019; Special Issue
Abstract
Whole exome and whole genome sequencing (WES/WGS) is increasingly utilized in inpatient settings such as neonatal and pediatric intensive care units (ICU), but no research has explored the process of informed consent in this setting. My experience as an inpatient genetic counselor has illuminated factors unique to the ICU that may threaten elements of informed consent such as voluntariness, disclosure, understanding, and capacity. I present three cases that exemplify elements complicating consent counseling for WES/WGS in the ICU, including the emotional state of the parents, involvements of other healthcare providers, environmental distractions and competing clinical priorities. I offer strategies to navigate these factors based on my experience.

Informed Consent and the Ethics of Placebo-Based Interventions in Clinical Practice [BOOK CHAPTER]
Marco Annoni, Franklin G. Miller
Placebos and Nocebos in Headaches, 12 February 2019; pp 135-142
Abstract
In this chapter we explore the ethics of informed consent with respect to the prescription of effective treatments, like acupuncture, that according to evidence-based standards have a prevalent placebo component. First, we review empirical studies demonstrating that placebo effects may significantly modulate symptoms in highly prevalent conditions, taking migraine as our case in point. Next, we chart the ethical implications of prescribing interventions that have been found slightly more effective than placebos and yet significantly better than no treatment—a class of remedies that we label as “placebo-based interventions.” We argue that, provided certain conditions are met, doctors may ethically prescribe placebo-based interventions in nondeceptive ways. By contrast, we contend the prescription of placebo treatments is incompatible with informed consent unless the true nature of the remedy is transparently disclosed to patients.