Volume 20, Issue 7, July 2020, Page 77-80.

Volume 20, Issue 9, September 2020, Page 18-20.

Volume 20, Issue 3, March 2020, Page 35-37.

The U.S. federal government provides two tracks for eligible patients to obtain access outside clinical trials to investigational interventions currently under study for potential clinical benefits: the Food and Drug Administration’s expanded access pathway and the pathway created by the more recent Right to Try Act. In this issue of the Hastings Center Report, with a critical focus on patients, industry, and the research enterprise, Kelly Folkers and colleagues frame the inherent challenges that these pathways are meant to solve and (...) have also inadvertently created. But an additional key focus is how the relevant situations should be managed at the bedside and how the system risks both inefficient and inequitable access to options at the institutional level. Although either pathway could be helpful to patients, the challenges of having the pathways coexist are greater than the sum of their parts. Individual clinicians represent the front line of the regulatory and eligibility challenges of expanded access and right to try, making clinical education a critical component of a comprehensive approach to using them well. But it is medical institutions that must take the lead on supporting access to investigational options in the most equitable and effective manner possible. (shrink)

Advance care planning allows patients to articulate preferences for their medical treatment, lifestyle, and surrogate decision-makers in order to anticipate and mitigate their potential loss of decision-making capacity. Written advance directives are often emphasized in this regard. While these directives contain important information, there are several barriers to consider: veracity and accuracy of surrogate decision-makers in making choices consistent with the substituted judgement standard, state-to-state variability in regulations, literacy issues, lack of access to legal resources, lack of understanding of medical (...) options, and cultural disparities. Given these issues, it is vital to increase the use of patient and healthcare provider conversations as an advance care planning tool and to increase integration of such discourse into advance care planning policy as adjuncts and complements to written advance directives. This paper reviews current legislation about written advance directives and dissects how documentation of spoken interactions might be integrated and considered. We discuss specific institutional policy changes required to facilitate implementation. Finally, we explore the ethical issues surrounding the increased usage and recognition of clinician–patient conversations in advance care planning. (shrink)

IntroductionDespite the need for trained physician ethicists, fellowships in clinical ethics are limited and primarily offered to thosewho have completed a graduate degree. The standardization of credentialing for clinical ethics consultants (CECs) and the restructuring of undergraduate medical education allow innovative models to train CECs that can provide an expanded opportunity for formal ethics training at an earlier stage.MethodsAt the University of Michigan Medical School we developed, implemented, and evaluated a pre-doctoral clinical ethics fellowship program from 2017 to 2019 for (...) senior medical students, designed to meet established competencies for CECs. Consultation notes from the beginning and end of the fellowship program were randomly selected for each fellow and independently rated by two faculty ethicists who used the validated Ethics Consultation Quality Assessment Tool (ECQAT).1 Inter rater reliability and trends in scores over time were calculated.ResultsThree students successfully completed the fellowship at the University of Michigan Medical School, conducted at least 50 formal ethics consultations, and spent approximately 40 hours a week on service for a minimum of six months. All students finished the fellowship with teaching and policy development experience, first-authored peer-reviewed manuscripts, and national presentations. The fellows demonstrated improvement in their ECQAT overall holistic rating score; all ended their fellowship with a holistic score of adequate or above. There was 92 percent agreement between raters withrespect to the acceptability of the fellows’ ethics consult notes. Two fellows have taken and passed the Healthcare Ethics Consultant-Certification (HEC-C) exam offered by the American Society for Bioethics and Humanities (ASBH).ConclusionsIntegration of a pre-doctoral fellowship model that meets professional certification standards for clinical ethics consultation creates an opportunity for medical students to become trained CECs early in their career. (shrink)

A thirty-year-old single mother with recurrent, metastatic, treatment-refractory cancer presents to the emergency room with severe difficulty breathing due to an obstructive tumor in her neck, compounded by progressive disease in her lungs and a new pulmonary embolism. She cannot be safely intubated and would require an emergent awake tracheotomy. Even if the airway can be successfully secured surgically, the likelihood that she will be able to be weaned from mechanical ventilation is very low. The surgeon, a young mother too, (...) appreciates the patient's desire for more time with her toddler. But the surgeon knows the significant risk of surgery, the massive responsibility she would accept in trying to get the patient through it, and the emotional toll of an intraoperative death on surgical staff. And she can imagine the second-guessing that will come during the inevitable morbidity and mortality conference if the patient should die in the perioperative window. Yet the surgeon does not want to take the “easy” way out; after all, critically ill patients undergo aggressive resuscitation all the time. What should she do? (shrink)

Suzie loves to talk. A successful mid-thirties businesswoman, she is a self-described social butterfly—which made her diagnosis of tongue cancer even more devastating. She came to the clinic complaining of a lump in her throat, which in most young healthy people turns out to be benign and easily treated. But not for Suzie, who had a very rare salivary tumor arising in the back of her tongue. Its slow growth was both a blessing and a curse; such tumors do not (...) kill people quickly, but they typically require surgery. It would slowly and relentlessly grow until and unless we removed most of her tongue. In head and neck surgery, issues of appearance, identity, function, and communication are the foremost considerations when we decide when, and whether, to operate. As the adage goes, knowing when not to operate is the sine qua non of the wise surgeon. But the inverse is also true. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Operating Through HatredAndrew G. Shuman“You’re not cutting my ***ing neck. The cancer is in my ***ing mouth.”While many patient encounters are memorable, Mr. K’s introduction to the head and [End Page 20] neck surgical oncology clinic is indelibly imprinted into the minds of all of the clinicians present on that certain autumn morning. This was, quite simply, a man who resonated hate. He was rude and disruptive. He insisted (...) on an expedited workup “without any waiting.” He questioned the ethnicity and nationality of his care providers. He told me, in no uncertain terms, that he did not appreciate my Jewish heritage—the swastika tattooed on his bicep underscored the point. He bragged about his recent incarceration for armed robbery. While my colleagues and I were tempted to simply refuse to assume his care, Mr. K had a bad problem—his recurrent tongue cancer required a major operation in order to offer him any hope for cure.Mr. K initially received an abbreviated course of radiation at an outside institution, which was limited by his non–compliance. While one might debate the wisdom of this decision in retrospect—in general, surgery is preferred for his type of tumor—the die was already cast. A heroic attempt at surgical salvage was now his only curative option. He previously sought care elsewhere... only to be fired by this original surgeon when Mr. K physically threatened him in the outpatient office during preoperative consultation. [It was the doctor’s fault for insulting him in the first place, Mr. K maintained... and no charges were filed.] We were, indeed, his last resort. Other than his recurrent cancer, Mr. K was robust; he was in his sixth decade, physically fit, and on the whole, fairly healthy. In the classic surgical lexicon, he was a reasonable surgical candidate. But was it reasonable to operate on such a person?I remember thinking, at the time, about our obligation to care for such an individual. Of course, being a medical professional carries with it many obligations, including a judicious assumption of personal risk. And, working in a tertiary care center begets the responsibility to assist referring clinicians in the management of difficult cases. Although professional obligations certainly have their limits, defining their bounds is decidedly more difficult. Paramount is creating an atmosphere of mutual trust and acceptance. Naturally, this was easier said than done in regard to Mr. K.Perhaps against our better judgment, we agreed to operate under the condition that he abide by strict behavioral ground rules, on our terms. We agreed upon the extent of the necessary operation (which indeed involved cutting his ***ing neck, much to his chagrin and reluctant acceptance). Mr. K promised to follow instructions for postoperative care. He assured us that he would not swear or yell (again). And, in the presence of hospital security, who reinforced our institutional policies regarding patient behavior, he guaranteed that he would not be verbally or physically violent or inappropriate, and would not make disparaging comments to other patients or staff. It seemed, at least, that we had an understanding.Needless to say, these rules were broken shortly after he awoke from surgery. I vividly remember being summoned from the OR when he threatened to murder his impressionable and terrified nurse a few days later, who would not acquiesce to his unreasonable demands. From that point onward, hospital security was deployed to his room regularly, and anything resembling a potential weapon was safeguarded. Any semblance of a mutual doctor–patient bond was shattered. At this point, everyone’s goal was simply to get Mr. K home.My visceral reactions to his behavior, while intense, were not unexpected, and fell in line with those of the entire team of clinicians caring for him. His antics brought his healthcare team together in collective unity (and condemnation). However, my surgical colleagues and I also felt somewhat guilty and responsible. While surgeons can choose to assume some degree of inherent personal danger in caring for a violent and angry patient, we also put the safety and soundness of the entire perioperative team in jeopardy, without necessarily seeking their input. But once we had decided to... (shrink)