Ethics of Outbreaks Position Statement. Part 1: Therapies, Treatment Limitations, and Duty to Treat.

OBJECTIVES: Outbreaks of disease, especially those that are declared a Public Health Emergency of International Concern, present substantial ethical challenges. Here we start a discourse (with a continuation of the dialogue in Ethics of Outbreaks Position Statement. Part 2: Family-Centered Care) concerning the ethics of the provision of medical care, research challenges and behaviors during a Public Health Emergency of International Concern with a focus on the proper conduct of clinical or epidemiologic research, clinical trial designs, unregistered medical interventions (including vaccine introduction, devices, pharmaceuticals, who gets treated, vulnerable populations, and methods of data collection), economic losses, and whether there is a duty of health care providers to provide care in such emergencies, and highlighting the need to understand cultural diversity and local communities in these efforts. DESIGN: Development of a Society of Critical Care Medicine position statement using literature review and expert consensus from the Society of Critical Care Medicine Ethics committee. The committee had representation from ethics, medical philosophy, critical care, nursing, internal medicine, emergency medicine, pediatrics, anesthesiology, surgery, and members with international health and military experience. SETTING: Provision of therapies for patients who are critically ill or who have the potential of becoming critically ill, and their families, regarding medical therapies and the extent of treatments. POPULATION: Critically ill patients and their families affected by a Public Health Emergency of International Concern that need provision of medical therapies. INTERVENTIONS: Not applicable. MAIN RESULTS: Interventions by high income countries in a Public Health Emergency of International Concern must always be cognizant of avoiding a paternalistic stance and must understand how families and communities are structured and the regional/local traditions that affect public discourse. Additionally, the obligations, or the lack of obligations, of healthcare providers regarding the treatment of affected individuals and communities must also be acknowledged. Herein, we review such matters and suggest recommendations regarding the ethics of engagement in an outbreak that is a Public Health Emergency of International Concern.

Ethics of Outbreaks Position Statement. Part 2: Family-Centered Care.

OBJECTIVES: Continue the dialogue presented in Ethics of Outbreaks Position Statement. Part 1, with a focus on strategies for provision of family-centered care in critical illness during Pubic Health Emergency of International Concern. DESIGN: Development of a Society of Critical Care Medicine position statement using literature review, expert consensus from the Society of Critical Care Medicine Ethics Committee. A family member of a patient who was critically ill during a natural disaster served on the writing panel and provided validation from a family perspective to the recommendations. SETTING: Provision of family-centered care and support for patients who are critically ill or who have the potential of becoming critically ill, and their families, during a Pubic Health Emergency of International Concern. INTERVENTIONS: Communication; family support. MEASUREMENTS AND MAIN RESULTS: Family-centered interventions during a Pubic Health Emergency of International Concern include understanding how crisis standards may affect regional and local traditions. Transparently communicate changes in decision-making authority and uncertainty regarding treatments and outcomes to the family and community. Assess family coping, increase family communication and support, and guide families regarding possible engagement strategies during crisis. Prepare the public to accept survivors returning to the community.

Cross-comparison of cardiac output trending accuracy of LiDCO, PiCCO, FloTrac and pulmonary artery catheters.

INTRODUCTION: Although less invasive than pulmonary artery catheters (PACs), arterial pulse pressure analysis techniques for estimating cardiac output (CO) have not been simultaneously compared to PAC bolus thermodilution CO (COtd) or continuous CO (CCO) devices. METHODS: We compared the accuracy, bias and trending ability of LiDCO™, PiCCO™ and FloTrac™ with PACs (COtd, CCO) to simultaneously track CO in a prospective observational study in 17 postoperative cardiac surgery patients for the first 4 hours following intensive care unit admission. Fifty-five paired simultaneous quadruple CO measurements were made before and after therapeutic interventions (volume, vasopressor/dilator, and inotrope). RESULTS: Mean CO values for PAC, LiDCO, PiCCO and FloTrac were similar (5.6 ± 1.5, 5.4 ± 1.6, 5.4 ± 1.5 and 6.1 ± 1.9 L/min, respectively). The mean CO bias by each paired method was -0.18 (PAC-LiDCO), 0.24 (PAC-PiCCO), -0.43 (PAC-FloTrac), 0.06 (LiDCO-PiCCO), -0.63 (LiDCO-FloTrac) and -0.67 L/min (PiCCO-FloTrac), with limits of agreement (1.96 standard deviation, 95% confidence interval) of ± 1.56, ± 2.22, ± 3.37, ± 2.03, ± 2.97 and ± 3.44 L/min, respectively. The instantaneous directional changes between any paired CO measurements displayed 74% (PAC-LiDCO), 72% (PAC-PiCCO), 59% (PAC-FloTrac), 70% (LiDCO-PiCCO), 71% (LiDCO-FloTrac) and 63% (PiCCO-FloTrac) concordance, but poor correlation (r(2) = 0.36, 0.11, 0.08, 0.20, 0.23 and 0.11, respectively). For mean CO < 5 L/min measured by each paired devices, the bias decreased slightly. CONCLUSIONS: Although PAC (COTD/CCO), FloTrac, LiDCO and PiCCO display similar mean CO values, they often trend differently in response to therapy and show different interdevice agreement. In the clinically relevant low CO range (< 5 L/min), agreement improved slightly. Thus, utility and validation studies using only one CO device may potentially not be extrapolated to equivalency of using another similar device.

Allograft en bloc vagino-utero-ovarian avascular transplant versus autograft implantation in rats.

OBJECTIVES: The aim of this study was to compare the results of an allograft en bloc vagino-uteroovarian avascular transplant with those of autograft implantation in rats. MATERIALS AND METHODS: Thirty-four inbred adult virgin female Albino rats (age range, 10 - 12 weeks) were divided into 2 groups: the control group (autograft, n=11) and the study group (en bloc vagino-utero-ovariectomy, n=23). In the study group, the uterus and adnexa and the ovaries of the donor rat were transplanted to the recipient animal. Twenty-five to 30 days after that procedure, all rats were killed, and the samples were assessed histopathologically. No immunosuppressive drugs were used. RESULTS: Ten rats died during the postoperative period. In 16 rats, the transplanted system had survived completely at the conclusion of the study. In each of the study groups, complete survival of the uterus and ovaries was noted in 8 rats (34.8% in the study group and 72.8% in the control group). In all rats except 1, histopathologic examination did not reveal any signs of the classic criteria for tissue rejection reaction. The lack of revascularization, nonspecific signs of inflammation, and the presence of large granular lymphocytes and natural killer cells were reported. CONCLUSIONS: Our data indicated that the outcome of both allograft and homograft avascular en bloc transplant of vagino-utero-ovariectomy in rats was successful, and that immunologic rejection did not seem to have an important role in those procedures.

Functional hemodynamic monitoring.

PURPOSE OF REVIEW: To assess the recent literature on effective use of information received from hemodynamic monitoring. RECENT FINDINGS: Dynamic hemodynamic measures are more effective in assessing cardiovascular status than static measures. In this review, we will focus on the application of hemodynamic monitoring to evaluate the effect of therapy. SUMMARY: A systematic approach to an effective resuscitation effort can be incorporated into a protocolized cardiovascular management algorithm, which, in turn, can improve patient-centered outcomes and the cost of healthcare systems, by faster and more effective response in order to diagnose and treat hemodynamically unstable patients both inside and outside of intensive care units.

The Impact of Changes in Medicare's Physician Payment System on Critical Care.

In 2015 President Obama signed the Medicare Access and CHIP Reauthorization Act (MACRA) which repealed the Sustainable Growth Rate (SGR) mechanism for Medicare physician reimbursement and mandated that CMS develop alternative payment methodologies to "reward health care providers for giving better care not more just more care." MACRA makes 3 major changes to Medicare reimbursements: (1) it ends the SGR formula; (2) it establishes a new framework to reward physicians based on performance and health outcomes rather than volume; and (3) it aims to combine existing quality reporting programs into one streamlined system. Beginning in 2019, physicians must enter one of two new tracks for payment: the Merit-based Incentive Payment System (MIPS) or Alternative Payment Models (APMs). SCCM has a unique opportunity as the largest multidisciplinary critical care organization to comment upon and, ideally, to help develop the new physician payment models specifically for critical care services. The time is now for SCCM and its individual members to become involved in the process.

Evidence-based review of the use of the pulmonary artery catheter: impact data and complications.

The pulmonary artery catheter (PAC) was introduced in 1971 for the assessment of heart function at the bedside. Since then it has generated much enthusiasm and controversy regarding the benefits and potential harms caused by this invasive form of hemodynamic monitoring. This review discusses all clinical studies conducted during the past 30 years, in intensive care unit settings or post mortem, on the impact of the PAC on outcomes and complications resulting from the procedure. Although most of the historical observational studies and randomized clinical trials also looked at PAC-related complications among their end-points, we opted to review the data under two main topics: the impact of PAC on clinical outcomes and cost-effectiveness, and the major complications related to the use of the PAC.

Bench-to-bedside review: human subjects research--are more standards needed?

There are many controversial issues surrounding ethics in study design and conduct of human subjects research. In this review we briefly touch on the origin of ethics in clinical research and how the current regulations and standards came into practice. We then discuss current controversies regarding informed consent, conflicts of interest, institutional review boards, and other relevant issues such as innovative procedures and quality improvement projects. The question of whether we need more standards is a very important yet challenging one to which there is no simple answer. We address this question by reviewing and commenting on relevant literature. We conclude that what is needed are not more standards per se, but rather refinement and uniformity of current standards, and their interpretation and application both to protect human subjects and to advance medicine.

Pulmonary artery occlusion increases the ratio of diffusing capacity for nitric oxide to carbon monoxide in prone sheep.

OBJECTIVE: To test the hypothesis that the ratio of diffusing capacity of the lung for nitric oxide (DLno) to diffusing capacity of the lung for carbon monoxide (DLco) would be affected by occlusion of a fraction of the pulmonary vascular bed. DESIGN: Interventional physiologic study. SETTING: Animal laboratory of a university hospital. SUBJECTS: Thirteen sheep. INTERVENTIONS: We simultaneously measured single-breath DLno and DLco in anesthetized and mechanically ventilated sheep (fraction of inspired oxygen [Fio(2)] of 1.0) before and after pulmonary artery occlusion by inflation of a balloon (n = 6), and by autologous clot embolism (n = 4). To see if the effect also occurred on Fio(2) of 0.21, four animals were studied during ventilation with room air, one of which was also in the Fio(2) of 1.0 group (14 total experiments with 13 sheep). RESULTS: On Fio(2) of 1.0, the mean DLno/Dlco ratio rose by 35% from 4.76 +/- 0.41 in control to 6.42 +/- 0.82 after balloon occlusion (p = 0.002), and by 54% from 7.55 +/- 2.09 to 11.6 +/- 2.61 (p = 0.005) after autologous clot embolism (+/- SD). An equivalent relative increase of 27% took place during ventilation with room air, but the DLno/DLco ratio was lower (3.14 +/- 0.22 in control and 3.98 +/- 0.38 after balloon occlusion). Independent of the method of obstruction or Fio(2), the increase in DLno/DLco ratio was mostly due to a drop in DLco. The DLno/Dlco ratio reduced much of the intersubject variability of either DLno or DLco alone. CONCLUSION: The DLno/DLco ratio increased after pulmonary artery occlusion regardless of the method of occlusion or Fio(2). This increase may be a result of a greater sensitivity of DLco than DLno to a regional reduction in capillary blood flow.

The effects of vasoactive drugs on pulse pressure and stroke volume variation in postoperative ventilated patients.

INTRODUCTION: Although pulse pressure variation (PPV) and stroke volume variation (SVV) during mechanical ventilation have been shown to predict preload responsiveness, the effect of vasoactive therapy on PPV and SVV is unknown. METHODS: Pulse pressure variation and SVV were measured continuously in 15 cardiac surgery patients for the first 4 postoperative hours. Pulse pressure variation was directly measured from the arterial pressure waveform, and both PPV and SVV were also calculated by LiDCO Plus (LiDCO Ltd, Cambridge, United Kingdom) before and after volume challenges or changes in vasoactive drug infusions done to sustain cardiovascular stability. RESULTS: Seventy-one paired events were studied (38 vasodilator, 10 vasoconstrictor, 14 inotropes, and 9 volume challenges). The difference between the measured and LiDCO-calculated PPV was 1% ± 7% (1.96 SD, 95% confidence interval, r(2) = 0.8). Volume challenge decreased both PPV and SVV (15% to 10%, P < .05 and 13% to 9%, P = .09, respectively). Vasodilator therapy increased PPV and SVV (13% to 17% and 9% to 15%, respectively, P < .001), whereas increasing inotropes or vasoconstrictors did not alter PPV or SVV. The PPV/SVV ratio was unaffected by treatments. CONCLUSION: Volume loading decreased PPV and SVV; and vasodilators increased both, consistent with their known cardiovascular effects. Thus, SVV and PPV can be used to drive fluid resuscitation algorithms in the setting of changing vasoactive drug therapy.