Defining the Time-limited Trial for Patients with Critical Illness: An Official American Thoracic Society Workshop Report.

In critical care, the specific, structured approach to patient care known as a "time-limited trial" has been promoted in the literature to help patients, surrogate decision makers, and clinicians navigate consequential decisions about life-sustaining therapy in the face of uncertainty. Despite promotion of the time-limited trial approach, a lack of consensus about its definition and essential elements prevents optimal clinical use and rigorous evaluation of its impact. The objectives of this American Thoracic Society Workshop Committee were to establish a consensus definition of a time-limited trial in critical care, identify the essential elements for conducting a time-limited trial, and prioritize directions for future work. We achieved these objectives through a structured search of the literature, a modified Delphi process with 100 interdisciplinary and interprofessional stakeholders, and iterative committee discussions. We conclude that a time-limited trial for patients with critical illness is a collaborative plan among clinicians and a patient and/or their surrogate decision makers to use life-sustaining therapy for a defined duration, after which the patient's response to therapy informs the decision to continue care directed toward recovery, transition to care focused exclusively on comfort, or extend the trial's duration. The plan's 16 essential elements follow four sequential phases: consider, plan, support, and reassess. We acknowledge considerable gaps in evidence about the impact of time-limited trials and highlight a concern that if inadequately implemented, time-limited trials may perpetuate unintended harm. Future work is needed to better implement this defined, specific approach to care in practice through a person-centered equity lens and to evaluate its impact on patients, surrogates, and clinicians.

Evolving Sex and Gender in Electronic Health Records.

Development, training, and documentation for the implementation of a self-identified gender identity field in the electronic health record system may improve patient-centered care for transgender and gender nonconforming patients.

Root Cause Analysis of ICU Adverse Events in the Veterans Health Administration.

BACKGROUND: ICUs' provision of complex care for critically ill patients results in an environment with a high potential for adverse events. A study was conducted to characterize adverse events in Veterans Health Administration (VHA) ICUs that underwent root cause analysis (RCA) and to identify the root causes and their recommended actions. METHODS: This retrospective observational study of RCA reports concerned events that occurred in VHA ICUs or as a result of ICU processes from January 1, 2013, through December 31, 2014. The type of event, root causes, and recommended actions were measured. RESULTS: Some 70 eligible RCAs were identified in 47 of the 120 facilities with an ICU in the VHA system. Delays in care (30.0%) and medication errors (28.6%) were the most common types of events. There were 152 root causes and 277 recommended actions. Root causes often involved rules, policies, and procedure processes (28.3%), equipment/supply issues (15.8%), and knowledge deficits/education (15.1%). Common actions recommended were policy, procedure, and process actions (34.4%) and training/education actions (31.4%). Of the actions implemented, 84.4% had a reported effectiveness of "much better" or "better." CONCLUSION: ICU adverse events often had several root causes, with protocols and process-of-care issues as root causes regardless of event type. Actions often included standardization of processes and training/education. Several recommendations can be made that may improve patient safety in the ICU, such as standardization of care process, implementation of team training programs, and simulation-based training.

Epidemiologic Review of Veterans Health Administration Patients with Isolation of Nontuberculous Mycobacteria after Cardiopulmonary Bypass Procedures.

We evaluated the isolation of postoperative nontuberculous mycobacteria (NTM) associated with heater-cooler devices (HCDs) used during cardiopulmonary bypass (CPB) surgery in the Veterans Health Administration from January 1, 2010, to December 31, 2016. In more than 38,000 CPB procedures, NTM was isolated in 111 patients; 1 Mycobacterium chimaera mediastinitis case and 1 respiratory isolate were found. Infect Control Hosp Epidemiol 2017;38:1103-1106.

An Official American Thoracic Society Workshop Report. A Framework for Addressing Multimorbidity in Clinical Practice Guidelines for Pulmonary Disease, Critical Illness, and Sleep Disorders.

Coexistence of multiple chronic conditions (i.e., multimorbidity) is the most common chronic health problem in adults. However, clinical practice guidelines have primarily focused on patients with a single disease, resulting in uncertainty about the care of patients with multimorbidity. The American Thoracic Society convened a workshop with the goal of establishing a strategy to address multimorbidity within clinical practice guidelines. In this Workshop Report, we describe a framework that addresses multimorbidity in each of the key steps of guideline development: topic selection, panel composition, identifying clinical questions, searching for and synthesizing evidence, rating the quality of that evidence, summarizing benefits and harms, formulating recommendations, and rating the strength of the recommendations. For the consideration of multimorbidity in guidelines to be successful and sustainable, the process must be both feasible and pragmatic. It is likely that this will be achieved best by the step-wise addition and refinement of the various components of the framework.

The Challenges of Conscientious Objection in Health care.

Conscientious objection (CO) is the refusal to perform a legal role or responsibility because of personal beliefs. In health care, conscientious objection involves practitioners not providing certain treatments to their patients, based on reasons of morality or "conscience." The development of conscientious objection among providers is complex and challenging. While there may exist good reasons to accommodate COs of clinical providers, the exercise of rights and beliefs of the provider has an impact on a patient's health and/ or their access to care. For this reason, it is incumbent on the provider with a CO to minimize or eliminate the impact of their CO both on the delivery of care to the patients they serve and on the medical system in which they serve patients. The increasing exercise of CO, and its impact on large segments of the population, is made more complex by the provision of government-funded health care benefits by private entities. The result is a blurring of the lines between the public, civic space, where all people and corporate entities are expected to have similar rights and responsibilities, and the private space, where personal beliefs and restrictions are expected to be more tolerated. This paper considers the following questions: (1) What are the allowances or limits of the exercise a CO against the rights of a patient to receive care within accept practice? (2) In a society where there exist "private," personal rights and responsibilities, as well as "civil" or public/shared rights and responsibilities, what defines the boundaries of the public, civil, and private space? (3) As providers and patients face the exercise of CO, what roles, responsibilities, and rights do organizations and institutions have in this interaction?

An official American Thoracic Society policy statement: managing conscientious objections in intensive care medicine.

RATIONALE: Intensive care unit (ICU) clinicians sometimes have a conscientious objection (CO) to providing or disclosing information about a legal, professionally accepted, and otherwise available medical service. There is little guidance about how to manage COs in ICUs. OBJECTIVES: To provide clinicians, hospital administrators, and policymakers with recommendations for managing COs in the critical care setting. METHODS: This policy statement was developed by a multidisciplinary expert committee using an iterative process with a diverse working group representing adult medicine, pediatrics, nursing, patient advocacy, bioethics, philosophy, and law. MAIN RESULTS: The policy recommendations are based on the dual goals of protecting patients' access to medical services and protecting the moral integrity of clinicians. Conceptually, accommodating COs should be considered a "shield" to protect individual clinicians' moral integrity rather than as a "sword" to impose clinicians' judgments on patients. The committee recommends that: (1) COs in ICUs be managed through institutional mechanisms, (2) institutions accommodate COs, provided doing so will not impede a patient's or surrogate's timely access to medical services or information or create excessive hardships for other clinicians or the institution, (3) a clinician's CO to providing potentially inappropriate or futile medical services should not be considered sufficient justification to forgo the treatment against the objections of the patient or surrogate, and (4) institutions promote open moral dialogue and foster a culture that respects diverse values in the critical care setting. CONCLUSIONS: This American Thoracic Society statement provides guidance for clinicians, hospital administrators, and policymakers to address clinicians' COs in the critical care setting.

Meeting physicians' responsibilities in providing end-of-life care.

Despite many clinical examples of exemplary end-of-life care, a number of studies highlight significant shortcomings in the quality of end-of-life care that the majority of patients receive. In part, this stems from inconsistencies in training and supporting clinicians in delivering end-of-life care. This review describes the responsibilities of pulmonary and critical care physicians in providing end-of-life care to patients and their families. While many responsibilities are common to all physicians who care for patients with life-limiting illness, some issues are particularly relevant to pulmonary and critical care physicians. These issues include prognostication and decision making about goals of care, challenges and approaches to communicating with patients and their family, the role of interdisciplinary collaboration, principles and practice of withholding and withdrawing life-sustaining measures, and cultural competency in end-of-life care.

Health disparities and differences in asthma: concepts and controversies.

Asthma is one of the most common respiratory diseases, with immense social impact. Despite best efforts, asthma prevalence, morbidity, and mortality are increasing in the United States. This is especially the case in select communities which suffer an excess burden of asthma. Studying these groups and attempting to ameliorate the disease burden they suffer has an important moral and social imperative. It also may lend important insight into the complex factors that contribute to asthma outcomes. The factors that affect asthma interact in a complicated manner and require a comprehensive approach that addresses each of them. However, pursuing health disparities research is controversial, and important ethical and operative considerations need to be made by those to engage in health disparities research.

Lessons from the ARDS network ventilator trial design controversy.

This article reviews the available published literature on the ARDSnet and summarizes the debate that occurred over the major ARDSnet trials. It discusses the challenges its organizers, supporters, and detractors faced. It reviews how uncertainty in research evolves and how it affects large trials of national or international scope. It also considers how the outcome of a scientific disagreement is shaped by the science and by how the debate is framed. The authors hope to illustrate some of the obstacles to performing outcome studies and clinical trials involving critically ill patients with complex syndromes that currently lack effective treatments.