Navigating Informed Consent and Patient Safety in Surgery: Lessons for Medical Students and Junior Trainees.

AbstractIn the operating room, patient safety is of paramount importance. Medical students and junior trainees, despite their primary role as students, may play active roles in assessing patient safety and reporting suspected errors. Active consent is one layer of patient safety that is continuously assessed by several team members. This article examines an instance where patient consent may have been violated. Through the lens of trainee and senior perspectives, we discuss the ethical principles at stake and provide recommendations for medical student and junior trainee involvement in patient care when an error is suspected.

Viewing Pediatric Food Oral Immunotherapy Through an Ethical Lens-A Narrative Systematic Review.

BACKGROUND: Food allergy remains a common problem and a lifelong condition for many children. In recent years, food allergy management has increasingly involved conversations about food oral immunotherapy (OIT). Although ethical considerations of autonomy, beneficence, nonmaleficence, and justice implicitly inform these conversations, applying these principles can be complex, particularly in young children. Families of young children assume a role of surrogate decision-maker and must balance immediate risks with the hope of longer-term benefits. OBJECTIVE: To explore implementation of OIT in children through an ethical lens. METHODS: To evaluate OIT through an ethical lens, we conducted a literature search to explore currently published frameworks in this area. RESULTS: Evaluation of the harm principle, the basic interest principle, and the best interest principle of parental decision-making can be informative. Shared decision-making continues to be central to the process of engaging with patient-family units to individualize the best care, at the right time, and minimize decisional discord. Although OIT is well-positioned to promote health and well-being, challenges to equity, sustainability, and organizational support must be considered to improve access for appropriate patients. CONCLUSIONS: Whereas approaches to food OIT may be tailored to the individual context of each patient-family unit, ethical principles must guide decisions to initiate and continue therapy. Traditional ethical principles of autonomy, beneficence, nonmaleficence, and justice remain cornerstones when considering the ethical context of OIT.

The role of ethicists in pediatric hematology/oncology: Current status and future needs.

As pediatric hematology/oncology (PHO) becomes more complex and sub-subspecialized, dedicated PHO ethicists have emerged as sub-subspecialists focused on addressing ethical issues encountered in clinical and research practices. PHO physicians and other clinicians with advanced training in bioethics contribute to the field through ethics research, education, and ethics consultation services. Furthermore, there exists a newer generation of PHO trainees interested in bioethics. This review details the experiences of current PHO ethicists, providing a blueprint for future educational, research and service activities to strengthen the trajectory of the burgeoning sub-subspecialty of PHO ethics. Creating an American Society of Pediatric Hematology/Oncology (ASPHO) ethics Special Interest Group, enhancing clinical ethics education for pediatric hematologists/oncologists (PHOs), developing multi-institutional research collaborations, and increasing attention to ethical issues germane to nonmalignant hematology will serve the interests of the entire field of PHO, enhancing the care of PHO patients and careers of PHOs.

Uterus Transplantation: Revisiting the Question of Deceased Donors versus Living Donors for Organ Procurement.

Uterus transplantation is a surgical treatment for women with congenital or acquired uterine factor infertility. While uterus transplantation is a life-enhancing transplant that is commonly categorized as a vascular composite allograft (e.g., face or hand), it is similar to many solid organ transplants (e.g., kidney) in that both living donors (LDs) and deceased donors (DDs) can be utilized for organ procurement. While many endpoints appear to be similar for LD and DD transplants (including graft survival, time to menses, livebirth rates), there are key medical, technical, ethical, and logistical differences between these modalities. Primary considerations in favor of a LD model include thorough screening of donors, enhanced logistics, and greater donor availability. The primary consideration in favor of a DD model is the lack of physical or psychological harm to a living donor. Other important factors, that may not clearly favor one approach over the other, are important to include in discussions of LD vs. DD models. We favor a stepwise approach to uterus transplantation, one in which programs first begin with DD procurement before attempting LD procurement to maximize successful organ recovery and to minimize potential harms to a living donor.

Problems with the problem list: challenges of transparency in an era of patient curation.

In recent years, the OpenNotes movement and other changes in healthcare have driven institutions to make medical records increasingly transparent. As patients have begun to question and request changes to their Problem Lists, clinicians have come to face the ever more frequent challenge of discerning which changes to make and which to refuse. Now clinicians and patients together choose the list of problems that represent the patient's current state of health and illness. As the physician's role slides closer to consultant and the medical paternalism of the twentieth century falls further into the background of our technology-infused present, who holds the power of delineating a patient's clinical identity? This paper examines the ethical and practical dimensions of this question and proposes a research agenda that aims to answer it. Such explorations are essential to ensuring that the physician remains relevant to patient's notions of health, illness, intervention, and healing.

Reprioritizing Risk and Benefit: The Future of Study Design in Early-Phase Cancer Research.

The scientific purpose of phase I trials is to determine the maximum tolerated dose and/or optimal biological dose of experimental agents. Yet most participants in phase I oncology trials enroll hoping for direct medical benefit. The most common phase I trial designs use low starting doses and escalate cautiously in a "risk-escalation" model focused on minimizing risk for each participant. This approach ensures that a proportion of subjects will likely not receive any benefit, even if the intervention proves to be successful at appropriate doses. In this article, we propose that trial designs should employ dosing strategies that increase chances of providing benefit if the investigational agent should prove to be successful while limiting risk to reasonable levels. We then describe how adaptive trial designs can facilitate refined dose optimization based on both therapeutic benefit and toxicity, which can simultaneously decrease the risk of harm while increasing the chances of benefit.

Informed Consent in IBD Trials: Where We Are and Where We Need to Go.

Patient enrollment is increasingly recognized as a major limiting factor to inflammatory bowel disease (IBD) clinical trial completion. Many IBD trials will fail to enroll enough patients to adequately power their study. This has led to a renewed multifaceted effort to encourage more patients to enroll in clinical trials. Although this is of clear importance, it is also important to ensure that all efforts to enroll patients in clinical trials do not compromise the quality and validity of the patient's/study participant's informed consent. Informed consent has 4 components: disclosure, voluntariness, understanding, and capacity. The application of informed consent to IBD clinical trials for biologic agents has not been previously studied. Yet the nature of clinical trials for biologics in IBD creates certain challenges to properly fulfilling the requirements of informed consent in the recruitment process that should be examined. In the following commentary, the components of informed consent are reviewed, challenges to their fulfillment in IBD trials are reviewed, and practical advice is offered.

Cardiopulmonary Resuscitation, Informed Consent, and Rescue: What Provides Moral Justification for the Provision of CPR?

Questions related to end-of-life decision making are common in clinical ethics and may be exceedingly difficult. Chief among these are the provision of cardiopulmonary resuscitation (CPR) and do-not-resuscitate orders (DNRs). To better address such questions, clarity is needed on the values of medical ethics that underlie CPR and the relevant moral framework for making treatment decisions. An informed consent model is insufficient to provide justification for CPR. Instead, ethical justification for CPR rests on the rule of rescue and on substituted interest judgments. Patients' known wishes and values are relevant, particularly in protecting them from unwanted CPR. Clinicians should rescue patients with the means at their disposal, as a prima facie moral imperative, unless there are compelling reasons to refrain. We present a moral framework for making decisions regarding CPR and DNR.

Ethical conundrums in pediatric genomics.

Recent genomic discoveries have improved our understanding of many hematologic diseases and led to novel therapeutic options for many patients. The rapid decrease in the cost of genomic testing has enabled widespread use of clinical genomic testing. However, these advances are accompanied by concomitant challenging ethical concerns. In pediatrics, issues of informed consent for genomic testing, assent, and permission vary significantly by patient age and comprehension. Broader testing strategies, such as whole-exome or whole-genome sequencing, are more likely to yield incidental findings unrelated to the reason for the initial test, and plans to deal with these results when they occur are increasingly important. The lines of clinical care and research are becoming more blurry in the era of precision medicine in which approaches to individual genetic mutations (as opposed to disease phenotypes) occur with increased frequency. Finally, because justice is a fundamental ethical consideration, access to genomic testing and a rigorous approach to utility are critical to individual patients and the field of hematology. In this review, we use 3 cases of genomic testing in pediatric hematology to illustrate core ethical concerns and explore potential solutions.

Therapeutic Misperceptions in Early-Phase Cancer Trials: From Categorical to Continuous.

Appropriate enrollment in early-phase clinical trials demands that potential research participants understand and appreciate critical study-related information, because discrepancies in understanding or appreciation can potentially invalidate informed consent to participate in research. Four terms were previously developed to categorize these discrepancies: therapeutic "misconception," "therapeutic misestimation," "therapeutic optimism," and "unrealistic optimism." In this article, we propose a continuous framework of therapeutic misperceptions, rather than discrete categorical concepts. One end of this continuum contains discrepancies in understanding, and at the other end are discrepancies in appreciation. Categorical terminologies represent points along this continuum. Discrepancies in understanding and appreciation each lead to unique ethical concerns and likely require different interventions. This framework highlights the dearth of empirical work on the appreciation end of the continuum, especially related to navigating persistent discrepancies in appreciation. Employing a continuous framework of therapeutic misperceptions supports a nuanced approach to the unique circumstances of each research subject, aiding researchers in supporting truly informed consent.

Informed Consent in Pediatric Anesthesia: A Narrative Review.

Informed consent for pediatric anesthesia challenges practitioners to navigate complex ethical, medical, and legal ambiguities. A patient's status as a minor does not negate the importance of his or her participation in the decision-making process but, rather, necessitates a nuanced evaluation of age and development to involve the patient to an appropriate extent. Given the complexities involved with pediatric informed consent in anesthesia practice and research, it is important to understand the experience of key stakeholders involved. For this review, we searched Medline, the Cochrane database, PROSPERO, and Clinicaltrials.gov for studies involving pediatric anesthesia informed consent. Inclusion and exclusion criteria were designed to select for studies that included issues related to informed consent as primary outcomes. The following data were extracted from included studies: title, authors, date of publication, study type, intervention, data collection method, participant type (ie, parent, pediatric patient, anesthesia provider), number of participants, pediatric patient age range, and primary outcome measures. Twenty-two articles were included for final review: studies of informed consent in pediatric anesthesia span many aspects of informed consent. Parental understanding has been studied most often (7/22 studies), followed by parental preferences (5/22 studies) and provider-related outcomes (5/22 studies) such as time spent interacting with patients, subjective reporting on amount of training related to informed consent, and provider satisfaction with the informed consent process. Outcomes pertaining to pediatric patients themselves constitute the smallest number of studies, including child anxiety (1/22), child understanding (1/22), and child refusal (1/22). Among the parties involved, parents have been most frequently identified as the subjects of these studies (2719/3805 subjects across all included studies, or 71% of all subjects). Pediatric patients are the least frequently involved subjects of studies that investigate informed consent in pediatric anesthesia (493/3805, or 13% of all subjects). Anesthesia providers and investigators have been study subjects (593/3805, or 16% of all subjects) for a range of topics including time spent interacting with patient, nature of informed consent conversation in relation to trainee status, satisfaction with informed consent process, and priorities for informed consent content. The aim of the present narrative review is to summarize the work that has been done on informed consent for pediatric anesthesia.