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Biomedical subjects

John M Luce

Publications and source records attributed to John M Luce.

25 records · Page 2Linked to original sources
PubMed2003

Is the concept of informed consent applicable to clinical research involving critically ill patients?

Informed consent is a process through which patients or their surrogates authorize medical interventions or involvement in research. The concept of informed consent is supported by ethical principles and legal tradition in the United States. It grew in importance during the 20th century because of documented abuse of research subjects, which led to its codification in federal consent requirements for clinical research. For the most part, the concept and the codification are based on a model of competent patients who are capable of informed decision-making and can communicate their wishes. However, most critically ill patients are incompetent and cannot communicate easily. As a result, family members usually must give consent for them. Yet family members frequently are unavailable, and when they are available, they may not know the patient's wishes. Furthermore, family members may not be legally authorized to give consent for research involvement under state law. For these and other reasons, it has been argued that the concept of informed consent is not applicable to clinical research involving the critically ill and that such consent is not necessary in certain circumstances. Yet, for all its inadequacies, the concept of informed consent and the federal consent requirements should be retained because they promote respect for patients and their right of self-determination and because investigator discretion is not adequate. Stronger research oversight may be as important as informed consent in protecting patient welfare.

Clinical Trials as Topic↗
PubMed2003

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

OBJECTIVE: The 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. PARTICIPANTS: Participants 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. METHODS: An 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 RESULTS: Seven 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. CONCLUSIONS: These 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.

Advance Directives↗
PubMed2002

Intensive care of human immunodeficiency virus-infected patients during the era of highly active antiretroviral therapy.

Highly active antiretroviral therapy for human immunodeficiency virus (HIV) infection has produced significant declines in morbidity and mortality from acquired immunodeficiency syndrome (AIDS). Whether this therapy has resulted in changes in epidemiology and outcomes of intensive care among HIV-infected patients is unknown. We performed chart review of all intensive care unit admissions for HIV-infected patients at San Francisco General Hospital from 1996 through 1999. There were an average of 88.5 admissions per year with 71% survival to hospital discharge. Univariate analysis demonstrated that prior highly active antiretroviral therapy (odds ratio [OR] = 1.8, p = 0.04), a non-AIDS-associated admission diagnosis (OR = 3.7, p = 0.001), a lower Acute Physiology and Chronic Health Evaluation II score (OR = 5.4, p = 0.001), and higher serum albumin (OR = 4.4, p = 0.001) predicted improved survival. Pneumocystis carinii pneumonia (OR = 0.24, p = 0.001), mechanical ventilation (OR = 0.19, p = 0.001), or a pneumothorax (OR = 0.08, p = 0.001) were associated with worse survival. In multivariate logistic regression, all variables except prior use of highly active antiretroviral therapy and pneumothorax were significant independent predictors of outcome. At our institution, overall survival for HIV-infected intensive care unit patients has improved, especially among patients receiving highly active antiretroviral therapy. These patients may have an improved survival because of effects of therapy on variables such as likelihood of non-AIDS-associated admission diagnoses and serum albumin levels.

Adult↗
PubMed2002

Corticosteroids in ARDS. An evidence-based review.

In general, a rule for corticosteroids in preventing or relieving the acute respiratory distress syndrome (ARDS) has yet to be established, although these drugs are indicated for conditions such as Pneumocystis carinii pneumonia. High-dose corticosteroids have not been shown to reduce mortality through their anti-inflammatory properties when given early to patients with sepsis, septic shock, or ARDS. Corticosteroids have been shown, however, to reduce mortality in patients with late ARDS only in one small, inconclusive study. More recent investigators have focused on the usefulness of low-dose corticosteroids in reducing mortality in patients with sepsis or septic shock who may have relative adrenal insufficiency, but these studies also are inconclusive, and it is unclear that low-dose corticosteroids affect the development of ARDS in these patients.

Adrenal Cortex Hormones↗
PubMed2002

Three patients who asked that life support be withheld or withdrawn in the surgical intensive care unit.

OBJECTIVE: To illustrate some of the difficulties encountered in the transition from restorative to palliative care and in the pursuit of patient autonomy in the intensive care unit. DESIGN: A review of the cases of three patients who asked that life support be withheld or withdrawn, and a discussion of the legal and ethical implications of these cases. SETTING: A surgical intensive care unit in an academically affiliated public hospital serving as a Level I trauma center. PATIENTS: Three adults with severe injuries who lacked legal surrogates and lost the ability to make medical decisions. INTERVENTIONS: Care from the attending surgery and consultative critical care services, in addition to consultations from the psychiatry service and the hospital ethics committee. MAIN RESULTS: All three patients died after life support was withheld or withdrawn, but not without conflicts among the various services. In two cases, decisions that the patients may or may not have agreed with were made for them by their physicians. In the third case, the patient was not consulted after his clinical situation changed. CONCLUSIONS: Patients' wishes change and are difficult to know, and even when they are known, physicians may have difficulty honoring them. Nevertheless, patient autonomy should be respected whenever possible in the intensive care unit.

Adult↗