Randomized, controlled clinical trial of the DIALIVE liver dialysis device versus standard of care in patients with acute-on- chronic liver failure.

Background & Aims: Acute-on-chronic liver failure (ACLF) is characterized by severe systemic inflammation, multi-organ failure and high mortality rates. Its treatment is an urgent unmet need. DIALIVE is a novel liver dialysis device that aims to exchange dysfunctional albumin and remove damage- and pathogen-associated molecular patterns.

Characterizing patients with asthma who received Global Initiative for Asthma steps 4-5 therapy and managed in a specialty care setting.

Background: Severe asthma is recognized in the European Respiratory Society/American Thoracic Society guidelines as a major unmet need in the management of asthma.

Objective: The study objective was to describe the clinical burden of Global Initiative for Asthma (GINA) steps 4-5 asthma for patients treated by specialists in the U.S.

Relative importance of PSA in prostate cancer treatment.

Methods And Materials: A retrospective study was conducted to (1) determine the relationship between baseline prostate-specific antigen (PSA) levels and initial treatment decisions for prostate cancer (surgery, hormone therapy, radiation, or watchful waiting) and (2) estimate the impact of PSA progression (doubling or three consecutive rises) on subsequent treatment decisions. Patient records (n=1116) from three community urology practices and a large academic health system were reviewed. Multivariate models were fitted to assess the relationship between initial treatment and baseline PSA, Gleason score, race, number of comorbid conditions and age and between PSA progression and time to subsequent therapy (adjusted for other factors).

The use of benchmarking to identify top performing critical care units: a preliminary assessment of their policies and practices.

Purpose: To describe the policies and practices of intensive care units (ICUs) with good patient survival and highly efficient resource use and to identify relevant variables for future investigation.

Materials And Methods: We used clinical data for 359,715 patients from 108 ICUs to compare the ratios of actual with Acute Physiology and Chronic Health Evaluation (APACHE) III predicted hospital mortality, ICU and hospital stay, and the proportion of low-risk monitor patients. The best performing ICUs (top 10%) were defined by a mortality ratio of 1.

Influence of coinfection with hepatitis C virus on morbidity and mortality due to human immunodeficiency virus infection in the era of highly active antiretroviral therapy.

To ascertain the impact of hepatitis C virus (HCV) infection on human immunodeficiency virus (HIV) disease progression and associated death in the era of highly active antiretroviral therapy (HAART), we examined mortality rates, the presence of other diseases, and antiretroviral use in an observational cohort of 823 HIV-infected patients with and without HCV coinfection during the period of January 1996 through June 2001. Analyses were used to compare patient characteristics, comorbid conditions, and survival durations in HIV-infected and HIV-HCV-coinfected patients. HIV-HCV-coinfected persons did not have a statistically greater rate of acquired immunodeficiency syndrome or of renal or cardiovascular disease, but they did have more cases of cirrhosis and transaminase elevations.

Prevalence and clinical correlates of HIV viremia ('blips') in patients with previous suppression below the limits of quantification.

Objective: To examine the prevalence and clinical correlates of subsequently measurable viremia in HIV-infected patients who have achieved viral suppression below the limits of quantification (< 50 copies/ml).

Design: Non-randomized dynamic cohort study of ambulatory HIV patients in nine HIV clinics in eight cities.

Patients: Patients had two consecutive HIV-1 RNA levels < 50 copies/ml (minimum, 2 months apart) that were followed by at least two more viral level determinations while remaining on the same antiretroviral therapy (ART) between January 1997 and June 2000 (median 485 days).

A multicenter description of intermediate-care patients: comparison with ICU low-risk monitor patients.

Study Objectives: To describe the characteristics and outcomes of patients admitted to intermediate-care areas (ICAs) and to compare them with those of ICU patients who receive monitoring only on day 1 and are at a low risk (i.e., < 10%) for receiving subsequent active life-supporting therapy (i.

Intensive care unit length of stay: recent changes and future challenges.

Objective: To compare case-mix adjusted intensive care unit (ICU) length of stay for critically ill patients with a variety of medical and surgical diagnoses during a 5-yr interval.

Design: Nonrandomized cohort study.

Setting: A total of 42 ICUs at 40 US hospitals during 1988-1990 and 285 ICUs at 161 US hospitals during 1993-1996.

Length of stay and therapeutic intervention allow estimation of in-hospital resource use independent of site and inflation.

Objectives: To develop and evaluate a model to estimate inpatient resource utilization for seriously ill patients using periodic medical record abstraction and hospital length of stay.

Design: A prospective cohort study of prognoses and preferences and outcomes of seriously ill hospitalized adults. The predictive model was based on the Therapeutic Intervention Scoring System (TISS), length of stay (LOS), and hospital site, and was developed on Phase I data and validated on Phase II data.

Predicting functional status outcomes in hospitalized patients aged 80 years and older.

Objective: To develop a model estimating the probability of a patient aged 80 years or older having functional limitations 2 months and 12 months after being hospitalized.

Design: A prospective cohort study.

Setting: Four teaching hospitals in the US.

Evaluation of acute physiology and chronic health evaluation III predictions of hospital mortality in an independent database.

Objective: To assess the accuracy and validity of Acute Physiology and Chronic Health Evaluation (APACHE) III hospital mortality predictions in an independent sample of U.S. intensive care unit (ICU) admissions.

Patient empowerment and feedback did not decrease pain in seriously ill hospitalized adults.

We tested a nurse clinician-mediated intervention to relieve pain in a group of seriously ill hospitalized adults using a randomized controlled trial at five tertiary care academic centers in the US. The study included 4804 patients admitted between January 1992 and January 1994 with one or more of nine high mortality diagnoses; 2652 were allocated to the intervention and 2152 to usual care. Specially-trained nurse clinicians assessed patients' pain, educated them and their families about pain control, empowered patients to expect pain relief, informed patients' nurses and physicians about level of pain and suggested or used other pain management resources.

The illusion of end-of-life resource savings with advance directives. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment.

Objective: Would increasing the documentation of advance directives (ADs) lead to a reduction in resource utilization? We examined this question by conducting three secondary analyses: (1) we tested for a change in resource use among those who died in the hospital at a time before and after an intervention that increased the documentation of ADs in the medical record; (2) we replicated analyses of published studies that reported an association of chart documentation of ADs and hospital resource use; and (3) we examined whether a potential explanation of the observed association is biased documentation of ADs among patients who have completed an AD.

Design: Replication of analysis of previous published studies using data from a prospective cohort study and block-randomized controlled trial.

Setting: Five teaching hospitals in the United States.

Pain during hospitalization is associated with continued pain six months later in survivors of serious illness. The SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments.

Purpose: To determine the level of pain reported by survivors of serious illness 2 and 6 months after study enrollment and to identify variables associated with later pain.

Patients And Methods: Observational cohort study of patients with interviews during hospitalization (5,652) and 2 (3,782) and 6 (2,984) months later admitted between June 1989 and January 1994 with 1 or more of 9 high mortality diagnoses admitted to 5 tertiary care academic centers in the United States. Patients' level of pain during the hospitalization and 2 and 6 months later was determined from interviews with patients and surrogates (most often family members).

The covariance decomposition of the probability score and its use in evaluating prognostic estimates. SUPPORT Investigators.

The probability score (PS) or Brier score has been used in a large number of studies in which physician judgment performance was assessed. However, the covariance decomposition of the PS has not previously been used to evaluate medical judgment. The authors introduce the technique and demonstrate it by analyzing prognostic estimates of three groups: physicians, their patients, and the patients' decision-making surrogates.

Predicting future functional status for seriously ill hospitalized adults. The SUPPORT prognostic model.

Objective: To develop a model estimating the probability of an adult patient having severe functional limitations 2 months after being hospitalized with one of nine serious illnesses.

Design: Prospective cohort study.

Setting: Five teaching hospitals in the United States.

Carotid atherosclerosis measured by B-mode ultrasound in populations: associations with cardiovascular risk factors in the ARIC study.

To assess whether carotid atherosclerosis measured by B-mode ultrasound is related to cardiovascular risk factors, 386 cases with carotid artery wall thickening and an equal number of controls free of arterial intima-media thickening were drawn from the cohort of the Atherosclerosis Risk in Communities (ARIC) Study examined in four communities in the United States between 1988 and 1990. Cases and controls were individually matched on sex, race, age group, study center, and date of examination. The mean values of total cholesterol, low density lipoprotein (LDL) cholesterol, total triglyceride, blood pressure, and pack-years of cigarette smoking were higher in cases than controls.

Optimization of the under-agarose assay of porcine neutrophil migration.

Important procedural factors in the under-agarose assay for porcine neutrophil migration were identified, and optimal conditions were established. Three factors were tested: the concentration of zymosan-activated serum inoculated into the outer well; the number of neutrophils inoculated into the center well; and the time of incubation of the agarose plates. All factors had a significant (P less than 0.