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.

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.

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.

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.

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.

Narrative evidence and evidence-based medicine.

I argue that evidence-based medicine (EBM) imposes methodological limits that constrain the practice and study of medicine in unfortunate ways. EBM attempts to rid the study of medicine of the subjectivity of individual judgements, while in fact, any use of any kind of evidence requires judgement. On this basis, I argue that there are compelling reasons to broaden the range of evidence employed in EBM, and in particular, to include both straightforward and evaluative narratives. This would mark a shift from the current focus of EBM on purely quantitative data to the inclusion of qualitative data as well. I conclude by emphasizing that objectivity in medicine must come not from the exclusion of wide swaths of potentially valuable evidence, but from the careful application of our critical practices.

Compromised autonomy and the seriously ill patient.

Respect for patient autonomy has become the preeminent principle of medical ethics, to the point that tools have been developed, such as instructive directives, in an attempt to preserve a semblance of autonomy even when it has become clearly and irretrievably lost. Much of the practice around the respect for autonomy, however, mistakenly supposes that the capacity for autonomous choice is an all-or-nothing proposition. But seriously ill patients may retain some ability to participate in discussions of medical care yet have their autonomy profoundly compromised by physical duress, cognitive dysfunction, or delirium. The choices of individuals with compromised autonomy do not carry the same moral weight as those of the fully autonomous. Clinicians, therefore, cannot rely on such choices for guiding medical decisions and are obligated to evaluate them more fully before acting. We argue that clinicians should compare the choices of individuals with compromised autonomy to a medical assessment of the patient's best interest. When the patient's choice and the best-interests assessment are discordant, acting in the patient's best interest may, at times, rightly override the requests of the patient. Such an approach, under a tightly constrained set of circumstances, would permit both the provision and the withholding of medical interventions despite patient requests to the contrary.