Long-term outcomes in survivors of acute respiratory distress syndrome ventilated in supine or prone position.

PURPOSE: The aim of this study is to examine long-term pulmonary function and quality of life in survivors of acute respiratory distress syndrome (ARDS) previously enrolled in a randomized multicenter trial testing prone compared with supine positioning (PSII study) at five Italian centers. DESIGN: Observational prospective study. SUBJECTS AND MEASUREMENTS: Pulmonary function [spirometric test, gas exchange, carbon monoxide diffusion capacity (DLCO)], high-resolution computed tomography (CT) scan, and health-related quality of life [Short Form-36 (SF-36) and St. George's Respiratory Questionnaire] were evaluated at 12 months. RESULTS: Twenty-six patients (13 in each group, mean age 54.1 ± 2.8 years, body mass index 24.5 ± 1.4 kg/m(2), PaO(2)/FiO(2) 117 ± 49 mmHg) were evaluated. There were no significant differences in demographic data, illness severity, or outcome between the prone and supine groups. The overall survival rate was 40%. Pulmonary function was in the normal range without any differences between the two groups. Quantitative lung CT scan analysis showed similar amounts for not aerated (8.1 ± 3.2% versus 7.3 ± 3.4%), poorly aerated (15.3 ± 3.6% versus 17.1 ± 4.9%), and well-aerated (64.0% ± 8.4 versus 70.2 ± 8.4%) lung regions, while overaerated lung region was slightly higher in the prone compared with the supine group (12.5 ± 6.5% versus 5.3 ± 5.5%). Health-related quality of life was similar to in healthy population. However, these patients showed reduction in daily activity specifically due to pulmonary disease as measured by the St. George's Respiratory Questionnaire. CONCLUSIONS: No differences in pulmonary function or quality of life were observed in this small group of ARDS survivor patients treated in prone versus supine position.

A validation study of a new nasogastric polyfunctional catheter.

PURPOSE: Pleural and abdominal pressure are clinically estimated by measuring the esophageal and bladder or intragastric pressure (IGP), respectively. A new nasogastric polyfunctional catheter is now commercially available, equipped with two balloons in the lower and distal part; this catheter allows simultaneous esophageal pressure (Pes) and IGP measurements and can be also used to feed the patient. We compared the Pes and IGP measured using this new device with those obtained with a standard balloon catheter taken as gold standard. METHODS: Twenty-four intubated patients requiring ventilator support (mean age 64.3 ± 16.8 years, body mass index 25.3 ± 3.0 kg/m(2), and PaO(2)/FiO(2) 280.8 ± 123.4 mmHg) were enrolled. Esophageal pressure and IGP were measured with the new nasogastric polyfunctional catheter (Nutrivent, Sidam, Italy) and with a standard balloon catheter (Smart Cath Viasys, USA). The Smart Cath was first inserted in the stomach and then retracted to the esophagus to measure IGP and Pes, respectively. In each patient two paired measurements were averaged. RESULTS: In the Bland-Altman analysis, the bias and agreement bands for Pes, ΔPes (computed as the difference of esophageal pressure between end-inspiration and expiration), and IGP were -0.25 (-2.65 to +2.15), 0.0 (-0.9 to +0.9), and -0.45 (-2.85 to + 1.95) cmH(2)O, respectively. No side effects or complications were recorded. CONCLUSIONS: The new polyfunctional catheter showed a clinically acceptable validity in recording esophageal and intragastric pressure. This device should help physicians to better individualize the clinical patient management.

Advanced HIV infection treated with zidovudine monotherapy: lifetime values of absolute cost-effectiveness as a pharmacoeconomic reference for future studies evaluating antiretroviral combination treatments. The Osservatorio SIFO sui Farmaci.

OBJECTIVE: This study was undertaken to evaluate the cost and the effectiveness of zidovudine monotherapy in patients with advanced HIV infection and to derive preliminary data on the cost-effectiveness of the triple treatment with saquinavir plus zalcitabine plus zidovudine compared with zidovudine alone. DESIGN: We used a combined method of survival analysis utilizing both the quality-adjusted time without symptoms or toxicity (Q-TWIST) method and the Gompertz approach. This combined method was applied to assess the absolute cost-effectiveness and cost-utility ratios of zidovudine monotherapy and to perform a preliminary incremental cost-effectiveness comparison of saquinavir plus zalcitabine plus zidovudine versus zidovudine alone. The clinical material used in our study was derived from two reports on the treatment of advanced HIV infection. Data of lifetime costs of HIV infection were obtained from published information. RESULTS: In patients with advanced HIV infection treated with zidovudine monotherapy, lifetime survival was 252.1 discounted person-years per 100 patients. Using an average lifetime cost of $93,000 (discounted) per individual, the absolute ratio of cost-effectiveness for zidovudine monotherapy was $36,980 per life-year, while the absolute cost-utility ratio was $47,112 per quality-adjusted life-year. In the comparative analysis of saquinavir plus zalcitabine plus zidovudine versus zidovudine alone, our calculations showed that the administration of the triple treatment can have an "average" cost-effectiveness, provided that mean lifetime survival per patient (discounted) is improved to at least 3.68 years (with an average survival gain of at least 14 mo per patient). CONCLUSIONS: The values of absolute cost-effectiveness and cost-utility ratios for zidovudine monotherapy are a useful reference point for further pharmacoeconomic studies in the area of antiretroviral drugs.