Understanding and Enhancing Sepsis Survivorship. Priorities for Research and Practice.

An estimated 14.1 million patients survive sepsis each year. Many survivors experience poor long-term outcomes, including new or worsened neuropsychological impairment; physical disability; and vulnerability to further health deterioration, including recurrent infection, cardiovascular events, and acute renal failure. However, clinical trials and guidelines have focused on shorter-term survival, so there are few data on promoting longer-term recovery. To address this unmet need, the International Sepsis Forum convened a colloquium in February 2018 titled "Understanding and Enhancing Sepsis Survivorship." The goals were to identify gaps and limitations of current research and shorter- and longer-term priorities for understanding and enhancing sepsis survivorship. Twenty-six experts from eight countries participated. The top short-term priorities identified by nominal group technique culminating in formal voting were to better leverage existing databases for research, develop and disseminate educational resources on postsepsis morbidity, and partner with sepsis survivors to define and achieve research priorities. The top longer-term priorities were to study mechanisms of long-term morbidity through large cohort studies with deep phenotyping, build a harmonized global sepsis registry to facilitate enrollment in cohorts and trials, and complete detailed longitudinal follow-up to characterize the diversity of recovery experiences. This perspective reviews colloquium discussions, the identified priorities, and current initiatives to address them.

Life After the Storm: Surviving COVID-19.

This article highlights the outcomes of COVID-19, from the perspective of surviving patients, health-care systems, and societies. It draws on first-person experience of what it is to go through and survive acute respiratory distress syndrome (ARDS) and multiple organ failure. It summarizes the research on the short- and long-term outcomes for critically ill patients. The physical, cognitive, and emotional sequalae are staggering. Health-care professionals and systems will have to step up to meet the challenge of caring for large numbers of COVID-19 patients after discharge. And societies will have to step up to the ethical questions that the pandemic has made so stark. What kind of societies do we want to be, in terms of guarding the welfare of our most vulnerable citizens?

Patient and Family Engagement in the ICU. Untapped Opportunities and Underrecognized Challenges.

The call for meaningful patient and family engagement in health care and research is gaining impetus. Healthcare institutions and research funding agencies increasingly encourage clinicians and researchers to work actively with patients and their families to advance clinical care and research. Engagement is increasingly mandated by healthcare organizations and is becoming a prerequisite for research funding. In this article, we review the rationale and the current state of patient and family engagement in patient care and research in the ICU. We identify opportunities to strengthen engagement in patient care by promoting greater patient and family involvement in care delivery and supporting their participation in shared decision-making. We also identify challenges related to patient willingness to engage, barriers to participation, participant risks, and participant expectations. To advance engagement, clinicians and researchers can develop the science behind engagement in the ICU context and demonstrate its impact on patient- and process-related outcomes. In addition, we provide practical guidance on how to engage, highlight features of successful engagement strategies, and identify areas for future research. At present, enormous opportunities remain to enhance engagement across the continuum of ICU care and research.

Methodologic Innovation in Creating Clinical Practice Guidelines: Insights From the 2018 Society of Critical Care Medicine Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption Guideline Effort.

OBJECTIVES: To describe novel guideline development strategies created and implemented as part of the Society of Critical Care Medicine's 2018 clinical practice guidelines for pain, agitation (sedation), delirium, immobility (rehabilitation/mobility), and sleep (disruption) in critically ill adults. DESIGN: We involved critical illness survivors from start to finish, used and expanded upon Grading of Recommendations, Assessment, Development and Evaluation methodology for making recommendations, identified evidence gaps, and developed communication strategies to mitigate challenges. SETTING/SUBJECTS: Thirty-two experts from five countries, across five topic-specific sections; four methodologists, two medical librarians, four critical illness survivors, and two Society of Critical Care Medicine support staff. INTERVENTIONS: Unique approaches included the following: 1) critical illness survivor involvement to help ensure patient-centered questions and recommendations; 2) qualitative and semiquantitative approaches for developing descriptive statements; 3) operationalizing a three-step approach to generating final recommendations; and 4) systematic identification of evidence gaps. MEASUREMENTS AND MAIN RESULTS: Critical illness survivors contributed to prioritizing topics, questions, and outcomes, evidence interpretation, recommendation formulation, and article review to ensure that their values and preferences were considered in the guidelines. Qualitative and semiquantitative approaches supported formulating descriptive statements using comprehensive literature reviews, summaries, and large-group discussion. Experts (including the methodologists and guideline chairs) developed and refined guideline recommendations through monthly topic-specific section conference calls. Recommendations were precirculated to all members, presented to, and vetted by, most members at a live meeting. Final electronic voting provided links to all forest plots, evidence summaries, and "evidence to decision" frameworks. Written comments during voting captured dissenting views and were integrated into evidence to decision frameworks and the guideline article. Evidence gaps, reflecting clinical uncertainty in the literature, were identified during the evidence to decision process, live meeting, and voting and formally incorporated into all written recommendation rationales. Frequent scheduled "check-ins" mitigated communication gaps. CONCLUSIONS: Our multifaceted, interdisciplinary approach and novel methodologic strategies can help inform the development of future critical care clinical practice guidelines.

Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU.

OBJECTIVE: To update and expand the 2013 Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium in Adult Patients in the ICU. DESIGN: Thirty-two international experts, four methodologists, and four critical illness survivors met virtually at least monthly. All section groups gathered face-to-face at annual Society of Critical Care Medicine congresses; virtual connections included those unable to attend. A formal conflict of interest policy was developed a priori and enforced throughout the process. Teleconferences and electronic discussions among subgroups and whole panel were part of the guidelines' development. A general content review was completed face-to-face by all panel members in January 2017. METHODS: Content experts, methodologists, and ICU survivors were represented in each of the five sections of the guidelines: Pain, Agitation/sedation, Delirium, Immobility (mobilization/rehabilitation), and Sleep (disruption). Each section created Population, Intervention, Comparison, and Outcome, and nonactionable, descriptive questions based on perceived clinical relevance. The guideline group then voted their ranking, and patients prioritized their importance. For each Population, Intervention, Comparison, and Outcome question, sections searched the best available evidence, determined its quality, and formulated recommendations as "strong," "conditional," or "good" practice statements based on Grading of Recommendations Assessment, Development and Evaluation principles. In addition, evidence gaps and clinical caveats were explicitly identified. RESULTS: The Pain, Agitation/Sedation, Delirium, Immobility (mobilization/rehabilitation), and Sleep (disruption) panel issued 37 recommendations (three strong and 34 conditional), two good practice statements, and 32 ungraded, nonactionable statements. Three questions from the patient-centered prioritized question list remained without recommendation. CONCLUSIONS: We found substantial agreement among a large, interdisciplinary cohort of international experts regarding evidence supporting recommendations, and the remaining literature gaps in the assessment, prevention, and treatment of Pain, Agitation/sedation, Delirium, Immobility (mobilization/rehabilitation), and Sleep (disruption) in critically ill adults. Highlighting this evidence and the research needs will improve Pain, Agitation/sedation, Delirium, Immobility (mobilization/rehabilitation), and Sleep (disruption) management and provide the foundation for improved outcomes and science in this vulnerable population.

Criterialism versus Deliberativism.

The argument in this paper is that the position of Schneiderman, Jecker, and Jonsen (2017) suffers from the very flaws of which they accuse the Multiorganization Policy Statement, and that all the ethical and conceptual arguments speak in favor of the collaborative, deliberativist position that underlies the Multiorganization Statement. That position is that we should abandon self-sealing definitions of futility, which disguise the value judgments inherent in them, in favor of the evolving, collaborative process of decision-making.

An Official ATS/AACN/ACCP/ESICM/SCCM Policy Statement: Responding to Requests for Potentially Inappropriate Treatments in Intensive Care Units.

BACKGROUND: There is controversy about how to manage requests by patients or surrogates for treatments that clinicians believe should not be administered. PURPOSE: This multisociety statement provides recommendations to prevent and manage intractable disagreements about the use of such treatments in intensive care units. METHODS: The recommendations were developed using an iterative consensus process, including expert committee development and peer review by designated committees of each of the participating professional societies (American Thoracic Society, American Association for Critical Care Nurses, American College of Chest Physicians, European Society for Intensive Care Medicine, and Society of Critical Care). MAIN RESULTS: The committee recommends: (1) Institutions should implement strategies to prevent intractable treatment conflicts, including proactive communication and early involvement of expert consultants. (2) The term "potentially inappropriate" should be used, rather than futile, to describe treatments that have at least some chance of accomplishing the effect sought by the patient, but clinicians believe that competing ethical considerations justify not providing them. Clinicians should explain and advocate for the treatment plan they believe is appropriate. Conflicts regarding potentially inappropriate treatments that remain intractable despite intensive communication and negotiation should be managed by a fair process of conflict resolution; this process should include hospital review, attempts to find a willing provider at another institution, and opportunity for external review of decisions. When time pressures make it infeasible to complete all steps of the conflict-resolution process and clinicians have a high degree of certainty that the requested treatment is outside accepted practice, they should seek procedural oversight to the extent allowed by the clinical situation and need not provide the requested treatment. (3) Use of the term "futile" should be restricted to the rare situations in which surrogates request interventions that simply cannot accomplish their intended physiologic goal. Clinicians should not provide futile interventions. (4) The medical profession should lead public engagement efforts and advocate for policies and legislation about when life-prolonging technologies should not be used. CONCLUSIONS: The multisociety statement on responding to requests for potentially inappropriate treatments in intensive care units provides guidance for clinicians to prevent and manage disputes in patients with advanced critical illness.

Medically Inappropriate or Futile Treatment: Deliberation and Justification.

This paper reframes the futility debate, moving away from the question "Who decides when to end what is considered to be a medically inappropriate or futile treatment?" and toward the question "How can society make policy that will best account for the multitude of values and conflicts involved in such decision-making?" It offers a pragmatist moral epistemology that provides us with (1) a clear justification of why it is important to take best standards, norms, and physician judgment seriously and (2) a clear justification of why ample opportunity must be made for patients, families, and society to challenge those standards and norms.

An official multi-society statement: the role of clinical research results in the practice of critical care medicine.

BACKGROUND: While the results of clinical research are clearly valuable in the care of critically ill patients, the limitations of such information and the role of other forms of medical knowledge for clinical decision making have not been carefully examined. METHODS: The leadership of three large professional societies representing critical care practitioners convened a diverse group representing a wide variety of views regarding the role of clinical research results in clinical practice to develop a document to serve as a basis for agreement and a framework for ongoing discussion. RESULTS: Consensus was reached on several issues. While the results of rigorous clinical research are important in arriving at the best course of action for an individual critically ill patient, other forms of medical knowledge, including clinical experience and pathophysiologic reasoning, remain essential. No single source of knowledge is sufficient to guide clinical decisions, nor does one kind of knowledge always take precedence over others. Clinicians will find clinical research compelling for a variety of reasons that go beyond study design. While clinical practice guidelines and protocols based upon clinical research may improve care and decrease variability in practice, clinicians must be able to understand and articulate the rationale as to why a particular protocol or guideline is used or why an alternative approach is taken. Making this clinical reasoning explicit is necessary to understand practice variability. CONCLUSIONS: Understanding the strengths and weaknesses of different kinds of medical knowledge for clinical decision making and factors beyond study design that make clinical research compelling to clinicians can provide a framework for understanding the role of clinical research in practice.

Symptom Assessment for Mechanically Ventilated Patients: Principles and Priorities: An Official American Thoracic Society Workshop Report.

Mechanically ventilated patients experience many adverse symptoms, such as anxiety, thirst, and dyspnea. However, these common symptoms are not included in practice guideline recommendations for routine assessment of mechanically ventilated patients. An American Thoracic Society-sponsored workshop with researchers and clinicians with expertise in critical care and symptom management was convened for a discussion of symptom assessment in mechanically ventilated patients. Members included nurses, physicians, a respiratory therapist, a speech-language pathologist, a critical care pharmacist, and a former intensive care unit patient. This report summarizes existing evidence and consensus among workshop participants regarding 1) symptoms that should be considered for routine assessment of adult patients receiving mechanical ventilation; 2) key symptom assessment principles; 3) strategies that support symptom assessment in nonvocal patients; and 4) areas for future clinical practice development and research. Systematic patient-centered assessment of multiple symptoms has great potential to minimize patient distress and improve the patient experience. A culture shift is necessary to promote ongoing holistic symptom assessment with valid and reliable instruments. This report represents our workgroup consensus on symptom assessment for mechanically ventilated patients. Future work should address how holistic, patient-centered symptom assessment can be embedded into clinical practice.

Case Report: What-or who-killed Frank Ramsey? Some reflections on cause of death and the nature of medical reasoning.

Philosopher Frank Ramsey died in 1930 aged only 26. There has been much speculation about the nature of his final illness and the sequence of events which led to his death. To prepare this case report, we traced Ramsey's medical records and combined them with an extensive and unique dataset of contemporaneous sources. We use these to evaluate three possible explanations for Ramsey's illness and its unexpectedly fatal trajectory-infectious (Weil's disease), autoimmune (primary sclerosing cholangitis) and obstructive (gallstones). We explore how uncertainty surrounding each of these possibilities might have influenced Ramsey's doctors' thoughts and actions, including their ill-fated decision to perform the emergency operation that appears to have precipitated his final decline. We then reflect on the unfinished opus on which Ramsey was working when he died-on the nature of truth and how humans reason under conditions of uncertainty. We end with some thoughts linking Ramsey's death to his philosophy.

Cognitive dysfunction after critical illness: measurement, rehabilitation, and disclosure.

A growing consensus seems to be emerging that neurocognitive outcomes are poor for patients who have been critically ill with acute respiratory distress syndrome and multiple organ failure. However, intensive care unit delirium, post-traumatic stress disorder, and other outcomes must be considered as potentially confounding factors. Once the uncertainty around the causes of postmorbid cognitive functioning is acknowledged, there are practical implications for appropriate rehabilitative interventions and there are ethical implications for the kinds of appropriate disclosure to patients.

Engaging Survivors of Critical Illness in Health Care Assessment and Policy Development. Ethical and Practical Complexities.

Health systems, granting agencies, and professional societies are increasingly involving patients and their family members in the delivery of health care and the improvement of health sciences. This is a laudable advance toward fully patient-centered medicine. However, patient engagement is not a simple matter, either practically or ethically. The complexities include (1) the physical limitations that patients and their family members may have, from traveling to meetings to special dietary needs; (2) the emotional sensitivities patients and their families might experience-from distress at discussions of disease prognosis, outcomes, and therapies to being inexperienced at public speaking; and (3) the fact that advocacy efforts by patients and family members, which may be encouraged at the national level, may threaten individual professionals providing care to individual patients and may result in risk to patients. In this article, a patient-physician and patient-bioethicist set out the obstacles, including ones that they have encountered in their own advocacy efforts. The aim is to survey the practical and ethical landscape so that solutions to various problems may be identified and solved as we move forward in our efforts to involve patients and their families in research, policy, and quality improvement in critical care medicine.

Medical futility: a new look at an old problem.

Efforts to answer the question of whether or when physicians may unilaterally refuse to provide treatments they deem medically futile, but that are nonetheless demanded by patients or their surrogates, have been characterized as intractable failures. We propose a new look at this old problem and suggest reframing the debate in terms of the implicit social contract, in healthy democracies, between the medical profession and the society it serves. This ever-evolving contract is predicated upon providing patients with beneficial and desired medical care within the constraints of scarce resources and the characteristics of our health-care system. The contract ranges over a continuum of decisions, from those that do not need an explicit negotiated agreement with the patient or surrogate, to those that do. Between these two poles lies a contentious gray area, where the rights and obligations of patients and physicians are being shaped continuously by the many forces that are at play in a democratic society, including professional guidelines, social advocacy, legislation, and litigation. We provide examples of how this gray area has been and is negotiated around rights to refuse and demand a variety of life-sustaining treatments, and anticipate conflicts likely to arise in the future. Reframing the futility debate in this way reveals that the issue is not a story of intractable failure, but rather, a successful narrative about how democracies balance the legitimate perspectives of patients and physicians against a backdrop of societal constraints and values.