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Biomedical subjects

John M Luce

Publications and source records attributed to John M Luce.

At least 19 recordsLinked to original sources
PubMed2006

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.

Health Care Rationing↗
PubMed2006

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OBJECTIVE: Many intensive care unit (ICU) physicians have withdrawn life-support from a patient who lacked decision-making capacity and a surrogate decision-maker, yet little is known about the decision-making practices for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 > or =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.

Adult↗
PubMed2005

International differences in end-of-life attitudes in the intensive care unit: results of a survey.

BACKGROUND: Important international differences exist in attitudes toward end-of-life issues in the intensive care unit. METHODS: A simple questionnaire survey was sent by e-mail to participants at an international meeting on intensive care medicine. Respondents were asked to choose 1 of 3 to 5 possible answers for each of 4 questions related to the treatment of a hypothetical patient in a vegetative state due to anoxic encephalopathy after cardiac arrest with no family and no advance directives. RESULTS: From 3494 valid addresses, 1961 complete questionnaires (56%) were received from 21 countries. Sixty-two percent of physicians from Northern and Central Europe said they involved nurses in end-of-life discussions compared with only 32% of physicians in Southern Europe, 38% in Brazil, 39% in Japan, and 29% in the United States (P<.001 for all comparisons). Written do-not-resuscitate orders were preferred in Northern and Central Europe, whereas oral orders took preference in Southern Europe, Turkey, and Brazil. One third of Japanese physicians said that they would not apply do-not-resuscitate orders. Most participants from Japan, Turkey, the United States, Southern Europe, and Brazil chose to treat the hypothetical patient with antibiotics if he/she developed septic shock, whereas in Northern Europe, Central Europe, Canada, and Australia, terminal withdrawal of mechanical ventilation and extubation were the more commonly chosen responses. CONCLUSIONS: In countries where intensive care medicine is relatively well developed, considerable differences remain in physicians' attitudes toward end-of-life care in the intensive care unit. Substantial work remains if an international consensus on these issues is to be reached.

Attitude to Death↗
PubMed2005

Intrinsic positive end-expiratory pressure in Acute Respiratory Distress Syndrome (ARDS) Network subjects.

OBJECTIVE: We tested the hypothesis that subjects randomized to the 6 mL/kg predicted body weight tidal volume study group of the National Institutes of Health Acute Respiratory Distress Syndrome (ARDS) Network study had higher levels of intrinsic positive end-expiratory pressure (PEEP) than subjects randomized to the 12 mL/kg predicted body weight tidal volume study group. DESIGN: Secondary analysis of a subgroup from a randomized controlled trial. SETTING: Hospitals located in San Francisco, CA, and Seattle, WA. PATIENTS: Eighty-four patients enrolled in the ARDS Network tidal volume trial in San Francisco, CA, and Seattle, WA, with records of measurement of intrinsic PEEP. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Intrinsic PEEP was assessed a median of six times over the first 48 hrs of ARDS Network protocol ventilation in study subjects, with no significant difference in number of measurements between subjects randomized to the tidal volume protocol of 6 mL/kg compared with 12 mL/kg. We found that intrinsic PEEP was higher among subjects randomized to the 6 mL/kg protocol, with a median intrinsic PEEP of 1.3 cm H2O (interquartile range, 0-3.1 cm H2O), compared with a median intrinsic PEEP of 0.5 cm H2O (interquartile range, 0-1.5 cm H2O) among subjects randomized to 12 mL/kg (p = .029). There was no difference in total PEEP between the study groups. CONCLUSIONS: In a subgroup of ARDS Network subjects, intrinsic PEEP was statistically significantly higher in subjects randomized to the 6 mL/kg protocol than those in the 12 mL/kg study group. The amount of intrinsic PEEP was very low in both study groups, and difference of median intrinsic PEEP between the groups was <1 cm H2O. It is unlikely that the difference in intrinsic PEEP between the study groups was clinically important in the ARDS Network study of low tidal volume ventilation.

Adult↗
PubMed2005

Recommendations for informed consent forms for critical care clinical trials.

BACKGROUND: Many subjects enrolled in research studies have a limited understanding of the research to which they consented. OBJECTIVE: To develop recommendations to enhance comprehensiveness and understanding of informed consent forms used in critical care clinical trials. DESIGN: Consensus process. RECOMMENDATIONS: We provide recommendations regarding the U.S. federally required basic and additional elements of informed consent as applied to critical care clinical trials. We also identify issues that investigators need to address, if relevant, in the informed consent forms of critical care clinical trials. These include the description, in understandable language, of complex and detailed experimental protocols that are the focus of the clinical trial, disclosure of death as a risk factor if mortality is an outcome variable, and the identification of who can legally serve as the prospective subject's surrogate. We also offer suggestions to enhance subjects' understanding of informed consent forms. CONCLUSIONS: The literature on informed consent forms suggest that shorter informed consent forms written at a lower reading level, when read carefully, might provide better subject understanding. Prospective evaluation is needed to determine whether our recommendations enhance the informed consent process.

Clinical Trials as Topic↗
PubMed2005

Clinical implementation of the ARDS network protocol is associated with reduced hospital mortality compared with historical controls.

OBJECTIVE: To assess the impact of implementing a low tidal volume ventilation strategy on hospital mortality for patients with acute lung injury or acute respiratory distress syndrome. DESIGN: Retrospective, uncontrolled study. SETTING: Adult medical-surgical and trauma intensive care units at a major inner city, university-affiliated hospital. PATIENTS: A total of 292 patients with acute lung injury or acute respiratory distress syndrome. INTERVENTIONS: Between the years 2000 and 2003, 200 prospectively identified patients with acute lung injury/acute respiratory distress syndrome were managed by the ARDS Network low tidal volume protocol. A historical control group of 92 acute respiratory distress syndrome patients managed by routine practice from 1998 to 1999 was used for comparison. MEASUREMENTS AND MAIN RESULTS: Patients managed with the ARDS Network protocol had a lower hospital mortality compared with historical controls (32% vs. 51%, respectively; p = .004). Multivariate logistic regression estimated an odds ratio of 0.32 (95% CI, 0.17-0.59; p = .0003) for mortality risk with use of the ARDS Network protocol. Protocol-managed patients had a lower tidal volume (6.2 +/- 1.1 vs. 9.8 +/- 1.5 mL/kg; p < .0001) and plateau pressure (27.5 +/- 6.4 vs. 33.8 +/- 8.9 cm H2O; p < .0001) than historical controls. CONCLUSION: Adoption of the ARDS Network protocol for routine ventilator management of acute lung injury/acute respiratory distress syndrome patients was associated with a lower mortality compared with recent historical controls.

APACHE↗
PubMed2004

Palliative care in the intensive care unit: barriers, advances, and unmet needs.

The concept that critical illness and terminal illness are necessarily distinct entities has given way to the understanding that they often exist on the same spectrum. Consequently, there is growing consensus that palliative treatment must coexist with attempts at restorative treatment in the intensive care unit (ICU). Palliative care in the ICU has evolved from a relatively one-dimensional construct of terminal sedation in dying patients to a multidisciplinary field addressing symptom control, physician-patient-family communication,spiritual needs, and the needs of health care providers. As ongoing research efforts yield new insights, our ability to practice evidence-based palliative care in the ICU will grow, and new avenues for improvement will become evident.

Advance Care Planning↗
PubMed2004

A content analysis of forms, guidelines, and other materials documenting end-of-life care in intensive care units.

OBJECTIVE: The purpose of this study was to determine the extent to which data entry forms, guidelines, and other materials used for documentation in intensive care units (ICUs) attend to 6 key end-of-life care (EOLC) domains: 1) patient and family-centered decision making, 2) communication, 3) continuity of care, 4) emotional and practical support, 5) symptom management and comfort care, and 6) spiritual support. A second purpose was to determine how these materials might be modified to include more EOLC content and used to trigger clinical behaviors that might improve the quality of EOLC. PARTICIPANTS: Fifteen adult ICUs-8 medical, 2 surgical, and 4 mixed ICUs from the United States, and 1 mixed ICU in Canada, all affiliated with the Critical Care End-of-Life Peer Workgroup METHODS: Physician-nurse teams in each ICU received detailed checklists to facilitate and standardize collection of requested documentation materials. Content analysis was performed on the collected documents, aimed at characterizing the types of materials in use and the extent to which EOLC content was incorporated. MEASUREMENTS AND MAIN RESULTS: The domain of symptom management and comfort care was integrated most consistently on forms and other materials across the 15 ICUs, particularly pain assessment and management. The 5 other EOLC domains of patient and family centered decision-making, communication, emotional and practical support, continuity of care, and spiritual support were not well-represented on documentation. None of the 15 ICUs supplied a comprehensive EOLC policy or EOLC critical pathway that outlined an overall, interdisciplinary, sequenced approach for the care of dying patients and their families. Nursing materials included more cues for attending to EOLC domains and were more consistently preprinted and computerized than materials used by physicians. Computerized forms concerning EOLC were uncommon. Across the 15 ICUs, there were opportunities to make EOLC- related materials more capable of triggering and documenting specific EOLC clinical behaviors. CONCLUSIONS: Inclusion of EOLC items on ICU formatted data entry forms and other materials capable of triggering and documenting clinician behaviors is limited, particularly for physicians. Standardized scales, protocols, and guidelines exist for many of the EOLC domains and should be evaluated for possible use in ICUs. Whether such materials can improve EOLC has yet to be determined.

Attitude of Health Personnel↗
PubMed2004

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.

Adolescent↗
PubMed2003

Research ethics and consent in the intensive care unit.

PURPOSE OF REVIEW: The subject of research ethics and informed consent in the ICU has recently received unprecedented attention during the past year, the reasons for which are reviewed herein. RECENT FINDINGS: The controversy over research design and informed consent issues in studies conducted by the Acute Respiratory Distress Syndrome Network in the United States have been responsible for much of the attention on research ethics. So has the draft directive to create a harmonization of the provisions governing clinical trials within the European Union. These and other factors have prompted renewed interest in the proper design of clinical trials, the difficulty of obtaining informed consent for research from critically ill patients and their surrogates, conflicts of interest on the part of investigators and their institutions, the need for improving institutional protections for human subjects, and the desirability of clarifying the investigator-subject relationship. SUMMARY: Clinical trials should compare new therapies with "standard" ones if a standard of care exists. Surrogate consent is required for research involving most critically ill subjects, and state laws in the United States and national statutes in Europe should reflect this requirement. Conflicts of interest should be identified at both the individual and the institutional levels. Institutional review boards should focus on ethical issues after conflicts of interest are evaluated. Making the investigator-subject relationship transparent should help protect subjects.

Conflict of Interest↗