John M. Luce

High-Dose Corticosteroids in Patients with the Adult Respiratory Distress Syndrome

Corticosteroids are widely used as therapy for the adult respiratory distress syndrome (ARDS) without proof of efficacy. We conducted a prospective, randomized, double-blind, placebo-controlled trial of methylprednisolone therapy in 99 patients with refractory hypoxemia, diffuse bilateral infiltrates on chest radiography and absence of congestive heart failure documented by pulmonary-artery catheterization. The causes of ARDS included sepsis (27 percent), aspiration pneumonia (18 percent), pancreatitis (4 percent), shock (2 percent), fat emboli (1 percent), and miscellaneous causes or more than one cause (42 percent). Fifty patients received methylprednisolone (30 mg per kilogram of body weight every six hours for 24 hours), and 49 received placebo according to the same schedule. Serial measurements were made of pulmonary shunting, the ratio of partial pressure of arterial oxygen to partial pressure of alveolar oxygen, the chest radiograph severity score, total thoracic compliance, and pulmonary-artery pressure. We observed no statistical differences between groups in these characteristics upon entry or during the five days after entry. Forty-five days after entry there were no differences between the methylprednisolone and placebo groups in mortality (respectively, 30 of 50 [60 percent; 95 percent confidence interval, 46 to 74] and 31 of 49 [63 percent; 95 percent confidence interval, 49 to 77]; P = 0.74) or in the reversal of ARDS (18 of 50 [36 percent] vs. 19 of 49 [39 percent]; P = 0.77). However, the relatively wide confidence intervals in the mortality data make it impossible to exclude a small effect of treatment. Infectious complications were similar in the methylprednisolone group (8 of 50 [16 percent]) and the placebo group (5 of 49 [10 percent]; P = 0.60). Our data suggest that in patients with established ARDS due to sepsis, aspiration, or a mixed cause, high-dose methylprednisolone does not affect outcome.

Recommendations for end-of-life care in the intensive care unit: A consensus statement by the American College of Critical Care Medicine

Background:These recommendations have been developed to improve the care of intensive care unit (ICU) patients during the dying process. The recommendations build on those published in 2003 and highlight recent developments in the field from a U.S. perspective. They do not use an evidence grading system because most of the recommendations are based on ethical and legal principles that are not derived from empirically based evidence. Principal Findings:Family-centered care, which emphasizes the importance of the social structure within which patients are embedded, has emerged as a comprehensive ideal for managing end-of-life care in the ICU. ICU clinicians should be competent in all aspects of this care, including the practical and ethical aspects of withdrawing different modalities of life-sustaining treatment and the use of sedatives, analgesics, and nonpharmacologic approaches to easing the suffering of the dying process. Several key ethical concepts play a foundational role in guiding end-of-life care, including the distinctions between withholding and withdrawing treatments, between actions of killing and allowing to die, and between consequences that are intended vs. those that are merely foreseen (the doctrine of double effect). Improved communication with the family has been shown to improve patient care and family outcomes. Other knowledge unique to end-of-life care includes principles for notifying families of a patient’s death and compassionate approaches to discussing options for organ donation. End-of-life care continues even after the death of the patient, and ICUs should consider developing comprehensive bereavement programs to support both families and the needs of the clinical staff. Finally, a comprehensive agenda for improving end-of-life care in the ICU has been developed to guide research, quality improvement efforts, and educational curricula. Conclusions:End-of-life care is emerging as a comprehensive area of expertise in the ICU and demands the same high level of knowledge and competence as all other areas of ICU practice.

Trimethoprim-Sulfamethoxazole or Pentamidine for Pneumocystis carinii Pneumonia in the Acquired Immunodeficiency Syndrome: A Prospective Randomized Trial

Forty patients with the acquired immunodeficiency syndrome (AIDS) and their first episodes of Pneumocystis carinii pneumonia were assigned at random to receive either trimethoprim-sulfamethoxazole or pentamidine isethionate. The two groups did not differ significantly in the severity of pulmonary or systemic processes at enrollment. Five patients treated initially with trimethoprim-sulfamethoxazole and one patient treated initially with pentamidine died during the 21-day treatment period (p = 0.09, Fishers exact test). No significant differences were seen between groups in rates of improvement, pulmonary function tests, or 67Ga uptake by the lungs in the survivors at completion of therapy. Adverse reactions necessitated changing from the initial drug in 10 patients in the trimethoprim-sulfamethoxazole group and 11 in the pentamidine group. Minor reactions occurred in all patients. In patients with AIDS, trimethoprim-sulfamethoxazole and pentamidine do not have statistically significant differences in efficacy or frequency of adverse reactions.

Quality indicators for end-of-life care in the intensive care unit.

ObjectiveThe primary goal of this study was to address the documented deficiencies in end-of-life care (EOLC) in intensive care unit settings by identifying key EOLC domains and related quality indicators for use in the intensive care unit through a consensus process. A second goal was to propose specific clinician and organizational behaviors and interventions that might be used to improve these EOLC quality indicators. ParticipantsParticipants were the 36 members of the Robert Wood Johnson Foundation (RWJF) Critical Care End-of-Life Peer Workgroup and 15 nurse-physician teams from 15 intensive care units affiliated with the work group members. Fourteen adult medical, surgical, and mixed intensive care units from 13 states and the District of Columbia in the United States and one mixed intensive care unit in Canada were represented. MethodsAn in-depth literature review was conducted to identify articles that assessed the domains of quality of EOLC in the intensive care unit and general health care. Consensus regarding the key EOLC domains in the intensive care unit and quality performance indicators within each domain was established based on the review of the literature and an iterative process involving the authors and members of the RWJF Critical Care End-of-Life Peer Workgroup. Specific clinician and organizational behaviors and interventions to address the proposed EOLC quality indicators within the domains were identified through a collaborative process with the nurse-physician teams in 15 intensive care units. Measurements and Main ResultsSeven EOLC domains were identified for use in the intensive care unit: a) patient- and family-centered decision making; b) communication; c) continuity of care; d) emotional and practical support; e) symptom management and comfort care; f) spiritual support; and g) emotional and organizational support for intensive care unit clinicians. Fifty-three EOLC quality indicators within the seven domains were proposed. More than 100 examples of clinician and organizational behaviors and interventions that could address the EOLC quality indicators in the intensive care unit setting were identified. ConclusionsThese EOLC domains and the associated quality indicators, developed through a consensus process, provide clinicians and researchers with a framework for understanding quality of EOLC in the intensive care unit. Once validated, these indicators might be used to improve the quality of EOLC by serving as the components of an internal or external audit evaluating EOLC continuous quality improvement efforts in intensive care unit settings.

Rationing critical care beds: A systematic review*

Objective:Rationing critical care beds occurs daily in the hospital setting. The objective of this systematic review was to examine the impact of rationing intensive care unit beds on the process and outcomes of care. Data Source:We searched MEDLINE (1966–2003), CINAHL (1982–2003), Ovid Healthstar (1975–2003), EMBASE (1980–2003), Scisearch (1980–2003), the Cochrane Library, PUBMED related articles, personal files, abstract proceedings, and reference lists. Study Selection:We included studies of seriously ill patients considered for admission to an intensive care unit bed during periods of reduced availability. We had no restriction on study design. Studies were excluded if rationing was performed using a scoring system or protocol and if cost-effectiveness was the only outcome. Data Extraction:In duplicate and independently, we performed data abstraction and quality assessment. Data Synthesis:We included ten observational studies. Hospital mortality rate was increased in patients refused intensive care unit admission vs. those admitted (odds ratio, 3.04; 95% confidence interval, 1.49–6.17). Factors associated with both intensive care unit bed refusal and increased mortality rate were increased age, severity of illness, and medical diagnosis. When intensive care unit beds were reduced, admitted patients were sicker, were less often admitted primarily for monitoring, and had a shorter intensive care unit length of stay, without other observed adverse effects. Conclusions:These studies suggest that patients who are perceived not to benefit from critical care are more often refused intensive care unit admission; refusal is associated with an increased risk of hospital death. During times of decreased critical bed availability, several factors, including age, illness severity, and medical diagnosis, are used to triage patients, although their relative importance is uncertain. Critical care bed rationing requires further investigation.

Rationing in the intensive care unit.

Background:Critical care services represent a large and growing proportion of health care expenditures. Limiting the magnitude of these costs while maintaining a just allocation of these services will require rationing. We define rationing as “the allocation of healthcare resources in the face of limited availability, which necessarily means that beneficial interventions are withheld from some individuals.” Although some have maintained that rationing of health care is unethical, we argue that rationing is not only unavoidable but essential to ensuring the ethical distribution of medical goods and services. Principal Findings:Intensivists have little to guide them in the rationing of critical care services. We have developed a taxonomy of the rationing choices faced by intensivists as a framework for ethical analysis. This taxonomy divides rationing decisions into three categories. First are those rationing decisions that may be justified by external constraints (such as not prescribing a potentially beneficial medication because it is not available on the hospital formulary). Second are those that may be justified by reference to clinical guidelines (as, for example, not prescribing a potentially beneficial medication because a valid guideline recommends treatment with a less expensive alternative). Third are those that are justified by individual clinical judgment (such as choosing which of two patients should be admitted into the last ICU bed, in the absence of any evidence-based guidance). Judgments made on the basis of clinical judgment deserve particular scrutiny, since they may mask unethical prejudices or bias. Conclusions:Although this taxonomy does not by itself determine which decisions are ethical, it does clarify the type of evidence that is appropriate to supporting the decision that is made. Additional work is needed to elucidate how both empirical evidence and ethical analysis can further inform the rationing decisions that arise in the taxonomy described here.

It's not just what the doctor tells me: factors that influence surrogate decision-makers' perceptions of prognosis.

Objective:Physicians and surrogate decision-makers for seriously ill patients often have different views of patients’ prognoses. We sought to understand what sources of knowledge surrogates rely on when estimating a patient’s prognosis. Design:Prospective, mixed-methods study using face-to-face, semistructured interviews with surrogate decision-makers. Setting:Four intensive care units at the University of California, San Francisco Medical Center in 2006 to 2007. Participants:Participants were 179 surrogate decision-makers for 142 incapacitated, critically ill patients at high risk for death. Main Results:Less than 2% (3 of 179) of surrogates reported that their beliefs about the patients’ prognoses hinged exclusively on prognostic information provided to them by physicians. The majority cited other factors in addition to physicians’ predictions that also contributed to their beliefs about the patients’ prognoses, including perceptions of the patient’s individual strength of character and will to live; the patient’s unique history of illness and survival; the surrogate’s own observations of the patient’s physical appearance; the surrogate’s belief that their presence at the bedside may improve the prognosis; and the surrogate’s optimism, intuition, and faith. For some surrogates, these other sources of knowledge superseded the importance of the physician’s prognostication. However, most surrogates endeavored to balance their own knowledge of the patient with physicians’ biomedical knowledge. Conclusions:Surrogates use diverse types of knowledge when estimating their loved ones’ prognoses, including individualized attributes of the patient, such as their strength of character and life history, of which physicians may be unaware. Attention to these considerations may help clinicians identify and overcome disagreements about prognosis.

End-of-Life Decision Making in the Intensive Care Unit

Increasingly in the United States and other countries, medical decisions, including those at the end of life, are made using a shared decision-making model. Under this model, physicians and other clinicians help patients clarify their values and reach consensus about treatment courses consistent with them. Because most critically ill patients are decisionally impaired, family members and other surrogates must make end-of-life decisions for them, ideally in accord with a substituted judgment standard. Physicians generally make decisions for patients who lack families or other surrogates and have no advance directives, based on a best interests standard and occasionally in consultation with other physicians or with review by a hospital ethics committee. End-of-life decisions for patients with surrogates usually are made at family conferences, the functioning of which can be improved by several methods that have been demonstrated to improve communications. Facilitative ethics consultations can be helpful in resolving conflicts when physicians and families disagree in end-of-life decisions. Ethics committees actually are allowed to make such decisions in one state when disagreements cannot be resolved otherwise.

Physicians do not have a responsibility to provide futile or unreasonable care if a patient or family insists.

OBJECTIVE This article was written to argue that physicians are not ethically obligated to provide care which they consider futile, unreasonable, or both, either voluntarily or in response to patient or surrogate demands. DATA SOURCES Data used to prepare this article were drawn from published articles, including original investigations, position papers and editorials in the authors personal files. STUDY SELECTION Articles were selected for their relevance to the subjects of medical ethics, the concepts of futility and medical reasonableness, case law, and healthcare reform. DATA EXTRACTION The author extracted all applicable data. DATA SYNTHESIS Physicians may feel obligated to provide care in all clinical circumstances due to the single master view of medicine and the ethical principle of autonomy. However, care may be considered futile according to several definitions of that word, including that which describes futile treatment as something that does not benefit the patient as a whole. Furthermore, care may be considered unreasonable if it is excessive and not generally agreed upon. Physician refusal to provide futile or unreasonable care is supported by the ethical principles of nonmaleficence, beneficence, and distributive justice. The last principle is particularly relevant in the current climate of healthcare reform. CONCLUSIONS Although the issue of physician refusal of requested care has not been resolved by case law or legal statute, it is supported by compelling ethical principles. Physicians are not ethically required to provide futile or unreasonable care, especially to patients who are brain dead, vegetative, critically or terminally ill with little chance of recovery, and unlikely to benefit from cardiopulmonary resuscitation.

Decisions to limit life-sustaining treatment for critically ill patients who lack both decision-making capacity and surrogate decision-makers*

Objective:Many intensive care unit (ICU) physicians have withdrawn life-support from a patient who lacked decision-making capacity and a surrogate decision-maker, yet little is known about the decision-making practices for these patients. We sought to determine how often such patients are admitted to the ICU of a metropolitan hospital and how end-of-life decisions are made for them. Design:Prospective, observational cohort study. Patients and Setting:Consecutive adult patients admitted to the medical ICU of a metropolitan West Coast hospital during a 7-month period in 2003 to 2004. Measurements:Attending physicians completed a questionnaire about the decision-making process for each patient for whom they considered limiting life-support who lacked decisional capacity and a legally recognized surrogate decision-maker. Main Results:Of the 303 patients admitted during the study period, 49 (16%; 95% confidence interval [CI], 12–21%) lacked decision-making capacity and a surrogate during the entire ICU stay. Compared with all other ICU patients, these patients were more likely to be male (88% vs. 69%; p = .002), white (42% vs. 23%; p = .028), and ≥65 yrs old (29% vs. 13%; p = .007). Physicians considered withholding or withdrawing treatment from 37% (18) of the 49 patients who lacked both decision-making capacity and a surrogate decision-maker. For 56% (10) of these 18 patients, the opinion of another attending physician was obtained; for 33% (6 of 18), the ICU team made the decision independently, and for 11% (2 of 18), the input of the courts or the hospital ethics committee was obtained. Overall, 27% of deaths (13 of 49) during the study period were in incapacitated patients who lacked a surrogate (95% CI, 15–41%). Conclusions:Sixteen percent of patients admitted to the medical ICU of this hospital lacked both decision-making capacity and a surrogate decision-maker. Decisions to limit life support were generally made by physicians without judicial or institutional review. Further research and debate are needed to develop optimal decision-making strategies for these difficult cases.