Simon Oczkowski

Communication Tools for End-of-Life Decision-Making in Ambulatory Care Settings: A Systematic Review and Meta-Analysis.

Background Patients with serious illness, and their families, state that better communication and decision-making with healthcare providers is a high priority to improve the quality of end-of-life care. Numerous communication tools to assist patients, family members, and clinicians in end-of-life decision-making have been published, but their effectiveness remains unclear. Objectives To determine, amongst adults in ambulatory care settings, the effect of structured communication tools for end-of-life decision-making on completion of advance care planning. Methods We searched for relevant randomized controlled trials (RCTs) or non-randomized intervention studies in MEDLINE, EMBASE, CINAHL, ERIC, and the Cochrane Database of Randomized Controlled Trials from database inception until July 2014. Two reviewers independently screened articles for eligibility, extracted data, and assessed risk of bias. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) was used to evaluate the quality of evidence for each of the primary and secondary outcomes. Results Sixty-seven studies, including 46 RCTs, were found. The majority evaluated communication tools in older patients (age >50) with no specific medical condition, but many specifically evaluated populations with cancer, lung, heart, neurologic, or renal disease. Most studies compared the use of communication tools against usual care, but several compared the tools to less-intensive advance care planning tools. The use of structured communication tools increased: the frequency of advance care planning discussions/discussions about advance directives (RR 2.31, 95% CI 1.25–4.26, p = 0.007, low quality evidence) and the completion of advance directives (ADs) (RR 1.92, 95% CI 1.43–2.59, p<0.001, low quality evidence); concordance between AD preferences and subsequent medical orders for use or non-use of life supporting treatment (RR 1.19, 95% CI 1.01–1.39, p = 0.028, very low quality evidence, 1 observational study); and concordance between the care desired and care received by patients (RR 1.17, 95% CI 1.05–1.30, p = 0.004, low quality evidence, 2 RCTs). Conclusions The use of structured communication tools may increase the frequency of discussions about and completion of advance directives, and concordance between the care desired and the care received by patients. The use of structured communication tools rather than an ad-hoc approach to end-of-life decision-making should be considered, and the selection and implementation of such tools should be tailored to address local needs and context. Registration PROSPERO CRD42014012913

β-Blockers in sepsis: protocol for a systematic review and meta-analysis of randomised control trials

Introduction Sepsis is a common and deadly complication of infection. As part of the host response, sympathetic stimulation can result in septic myocardial depression, and metabolic, haematological and immunological dysfunction. Administration of β-blockers may attenuate this pathophysiological response to infection, but the effects on clinical outcomes are unknown. The objective of this systematic review is to determine the efficacy and safety of β-blockers in adults with sepsis using data from randomised control trials. Methods and analysis We will identify randomised control trials comparing treatment with β-blockers, versus placebo or standard care in adults with sepsis. Data sources will include MEDLINE, EMBASE, CENTRAL, clinical trial registries and conference proceedings. Two reviewers will independently determine trial eligibility. For each included trial, we will conduct duplicate independent data extraction, risk of bias assessment and evaluation of the quality of the evidence using the GRADE approach. Ethics and dissemination Our systematic review will evaluate the effects of β-blockers in adults with sepsis, comprehensively summarising and appraising the available evidence from randomised control trials. The results of this systematic review will help clinicians treating patients with sepsis to understand the potential role of β-blockade, and inform future research on this topic. Our findings will be disseminated through conference presentation and publication in a peer-reviewed journal. Trial registration number CRD42016036933.

Antimicrobial stewardship programmes: bedside rationing by another name?

Antimicrobial therapy is a cornerstone of therapy in critically ill patients; however, the wide use of antibiotics has resulted in increased antimicrobial resistance and outbreaks of resistant disease. To counter this, many hospitals have instituted antimicrobial stewardship programmes as a way to reduce the inappropriate use of antibiotics. However, uptake of antimicrobial stewardship programmes has been variable, as many clinicians fear that they may put individual patients at risk of treatment failure. In this paper, I argue that antimicrobial stewardship programmes are indeed a form of bedside rationing, and explore the risks and benefits of such programmes for individual patients in the intensive care unit, and the critically ill population in general. Using Norman Daniels’ Accountability for Reasonableness as a framework for evaluating resource allocation policies, I conclude that antimicrobial stewardship programmes are an ethically sound form of bedside rationing.

Corticosteroids in sepsis: an updated systematic review and meta-analysis (protocol)

Introduction Sepsis is associated with a dysregulated host response to infection and impaired endogenous corticosteroid metabolism. As such, therapeutic use of exogenous corticosteroids is a promising adjunctive intervention. Despite a large number of trials examining this research question, uncertainty persists regarding the effect of corticosteroids on survival in sepsis. Several large randomised controlled trials have been published recently prompting a re-evaluation of the available literature. Methods and analysis A rigorous and reproducible search and screening process from a Cochrane review on the same topic was comprehensive to October 2014. We will search MEDLINE, EMBASE, LILACS, the Cochrane trial registry and clinicaltrials.gov for eligible randomised controlled trials investigating the use of corticosteroids in patients with sepsis from September 2014. Outcomes have been chosen by a semi-independent guideline panel, created in the context of a parallel BMJ Rapid Recommendation on the topic. This panel includes clinicians, content experts, methodologists and patient representatives, who will help identify patient-important outcomes that are critical for deciding whether to use or not use corticosteroids in sepsis. Two reviewers will independently screen and identify eligible studies; a third reviewer will resolve any disagreements. We will use RevMan to pool effect estimates from included studies for each outcome using a random-effect model. We will present the results as relative risk with 95% CI for dichotomous outcomes and as mean difference or standardised mean difference for continuous outcomes with 95% CI. We will assess the certainty of evidence at the outcome level using the Grading of Recommendations, Assessment, Development and Evaluation approach. We will conduct a priori subgroup analyses, which have been chosen by the parallel BMJ Rapid Recommendation panel. Ethics and dissemination The aim of this systematic review is to summarise the updated evidence on the efficacy and safety of corticosteroids in patients with sepsis. Trial registration number CRD42017058537.

Furosemide and albumin for diuresis of edema (FADE): a study protocol for a randomized controlled trial

BackgroundFluid retention is a common complication of critical illness. It typically results from large-volume fluid infusions during acute resuscitation and is worsened by hypoalbuminemia. Recognized as edema, fluid retention is important for its association with delayed weaning and increased mortality. The standard treatment is the administration of diuretics, with or without albumin. We hypothesize that intravenous 25% albumin plus furosemide, by comparison with furosemide alone, improves diuresis, oxygenation, and hemodynamic stability in the deresuscitation of critically ill, hypoalbuminemic patients. We propose a pilot study to determine the feasibility of a trial to investigate this hypothesis.Methods/DesignFADE is a single-center, parallel, pilot randomized controlled trial. We aim to allocate 50 hemodynamically stable, hypoalbuminemic adult patients receiving diuresis to treatment with either 100 ml of either 25% albumin or normal saline placebo twice daily, for a total of six doses. Diuretics are to be prescribed by the caregiving team at least twice daily, and administered within 2 hours following study treatment. Patients, intensive care unit (ICU) clinicians, data collectors, and outcome adjudicators will be blinded to treatment allocation. Feasibility outcome measures include the proportion of patients receiving albumin within 2 hours of diuretic, the proportion of patients receiving the full six doses of study treatment, the proportion of patients who receive open label 25% albumin, and the rate of recruitment. Physiologic, laboratory, and clinical data are collected until discharge from the ICU or until 30 days.DiscussionThis is the first randomized trial to assess the use of hyperoncotic albumin in addition to diuretics in a general ICU population. Should this pilot study demonstrate feasibility, the primary outcome measure of the larger clinical trial will be the number of ventilator-free days, with secondary clinical outcome measures of duration of mechanical ventilation, length of ICU stay, episodes of hemodynamic instability and mortality. The addition of 25% albumin to standard diuretic therapy is a promising treatment in the post-resuscitation care of the critically ill patient.Trial registrationClinicalTrials.govNCT02055872;ISRCTN70191881.

Virtuous laughter: we should teach medical learners the art of humor

There is increasing recognition of the stress and burnout suffered by critical care workers. Physicians have a responsibility to teach learners the skills required not only to treat patients, but to cope with the demands of a stressful profession. Humor has been neglected as a strategy to help learners develop into virtuous and resilient physicians. Humor can be used to reduce stress, address fears, and to create effective health care teams. However, there are forms of humor which can be hurtful or discriminatory. In order to maximize the benefits of humor and to reduce its harms, we need to teach and model the effective and virtuous use of humor in the intensive care unit.

Withdrawing versus not offering cardiopulmonary resuscitation: Is there a difference?

Conflict between substitute decision makers (SDMs) and health care providers in the intensive care unit is commonly related to goals of treatment at the end of life. Based on recent court decisions, even medical consensus that ongoing treatment is not clinically indicated cannot justify withdrawal of mechanical ventilation without consent from the SDM. Cardiopulmonary resuscitation (CPR), similar to mechanical ventilation, is a life-sustaining therapy that can result in disagreement between SDMs and clinicians. In contrast to mechanical ventilation, in cases for which CPR is judged by the medical team to not be clinically indicated, there is no explicit or case law in Canada that dictates that withholding/not offering of CPR requires the consent of SDMs. In such cases, physicians can ethically and legally not offer CPR, even against SDM or patient wishes. To ensure that nonclinically indicated CPR is not inappropriately performed, hospitals should consider developing ‘scope of treatment’ forms that make it clear that even if CPR is desired, the individual components of resuscitation to be offered, if any, will be dictated by the medical team’s clinical assessment.

When and how should we cluster and cross over: methodological and ethical issues (letter 1)

To the Editor, The editorial by Goldstein et al. expresses concern regarding the methods and ethics of our BenzodiazepineFree Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial, suggesting that waived consent cannot be justified when interventions are administered directly to individuals. In our view, however, international guidelines and current practice support the concept that trials evaluating treatments administered directly to individual patients can fulfill the requirements for a waiver of individual consent, provided that they have minimal risk. There are many completed and ongoing cluster trials that test policies related to the use of pharmacologic and other interventions where waiver of consent has been accepted. Such trials include: conventional vs incremental

A Multicenter Qualitative Investigation of the Experiences and Perspectives of Substitute Decision Makers Who Underwent Organ Donation Decisions

Background: Organ donation research has centered on improving donation rates rather than focusing on the experience and impact on substitute decision makers. The purpose of this study was to document donor and nondonor family experiences, as well as lasting impacts of donation. Methods: We used a qualitative exploratory design. Semistructured interviews of 27 next-of-kin decision makers were conducted, transcribed verbatim, and entered into qualitative software. We analyzed the process-based reflections using inductive coding and thematic analysis techniques. Results: Four broad and interrelated themes emerged from the data: empathetic care, information needs, donation decision, and impact and follow-up. The donation experience left lasting impacts on family members due to lingering, unanswered questions. Suggested solutions to improve the donor experience for families included providers employing multimodal communication, ensuring a proper setting for family meetings, and the presence of a support person. Discussion: We now have improved our understanding of the donation process from the perspective of and final impression from the next of kin. To our knowledge, this is the largest cohort interviewed in Canada. We have explored families’ experiences, which included but did not end with donation. We learned that despite being appreciative of nurses, physicians, and organ and tissue donation coordinators, family members were often troubled by unanswered questions. Conclusion: This study described donor and nondonor family experiences with donation as well as lasting impacts. Addressing unanswered questions should be done in a place sufficiently remote from the donation event to enhance the family members’ understanding and well-being.

Furosemide and Albumin for Diuresis of Edema (FADE): A parallel-group, blinded, pilot randomized controlled trial

Purpose: To assess the feasibility of a trial evaluating whether hyperoncotic albumin, in addition to diuretics, improves diuresis and facilitates liberation from mechanical ventilation in critically ill adults. Materials and methods: We randomized 46 hemodynamically stable patients with hypoalbuminemia, prescribed diuretics by treating clinicians, to receive 100 mL of 25% albumin or 0.9% saline placebo BID, for three days, in blinded fashion. We chose five feasibility measurements: enrolment of 50% of eligible patients, at least one patient/week; administration of study treatment within 2 h of diuretics in 85% of patients; completion of study regimen in 80% of patients; and avoidance of open label albumin in 85% of patients. Clinical outcomes included fluid balance, ventilator‐free days, and mortality. Results: We randomized 85% of eligible patients. Eighty‐four percent received study treatment within 2 h of diuretics, 69% received all doses of study treatment. Study treatment was held in the albumin and placebo groups because of no further need for diuresis (4 vs. 1), hypotension (2 v. 4), and albumin > 35 (1 v. 0). Twenty percent of patients received open‐label albumin. Clinical outcomes were similar between groups. Conclusions: The current study design did not demonstrate feasibility, but can inform the design of a definitive trial.