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Healthcare costs and long-term outcomes after acute respiratory distress syndrome: A phase III trial of inhaled nitric oxide*

Angus, Derek C. MD, MPH; Clermont, Gilles MD, MSc; Linde-Zwirble, Walter T.; Musthafa, Amjad A. MBBS; Dremsizov, Tony T. MBA; Lidicker, Jeffrey MA, MS; Lave, Judith R. PhD on behalf of the NO-06 Investigators

doi: 10.1097/01.CCM.0000248727.29055.25
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Objective: To determine the costs and long-term outcomes of acute respiratory distress syndrome (ARDS) in previously healthy adults. To determine whether treatment with inhaled nitric oxide affects these costs and outcomes.

Design: One-year follow-up of a randomized trial of inhaled nitric oxide. Hospital bills were collected, and follow-up was performed at hospital discharge, 6 months, and 1 year.

Setting: Forty-six U.S. centers.

Patients: Three hundred and eighty-five previously healthy adults with ARDS.

Interventions: Subjects were randomized to 5 ppm inhaled nitric oxide or placebo gas.

Measurements and Main Results: One-year survival was 67.8%, with no difference by treatment arm (67.3% vs. 68.3% for inhaled nitric oxide vs. placebo, p = .71). Hospital costs from enrollment to discharge were high and similar in the inhaled nitric oxide and placebo arms ($48,500 vs. $47,800, p = 0.8). There were also no differences in length of stay or Therapeutic Intervention Scoring System points. Almost half (43.4%) of subjects were discharged to another healthcare facility or to home with professional help, and 24.1% were readmitted in 6 months, with no differences between groups. At 1 year, survivors reported low quality of life with no differences by treatment arm (Quality of Well-Being score [range 0–1], 0.61 vs. 0.64 for inhaled nitric oxide vs. placebo, p = .11) and poor function with no differences by treatment arm (32.5% returned to ≤5 points of baseline Activities of Daily Living [range 0–100], 63.3% returned to ≤10 points, and the remaining 36.7% suffered a mean decrement of 27 points).

Conclusions: ARDS, even in previously healthy adults, not only is followed by poor survival, quality of life, and function but also is associated with high costs of care and postdischarge resource use. Inhaled nitric oxide at 5 ppm had no effect on these outcomes.

From the CRISMA Laboratory (Clinical Research, Investigation, and Systems Modeling of Acute Illness), Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA (DCA, GC, TTD); ZD Associates, Perkasie, PA (WTLZ); Redding Critical Care Medical Group, Redding, CA (AAM); Department of Statistics, Temple University, Philadelphia, PA (JL); and the Division of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, PA (JRL).

Supported, in part, by INO Therapeutics, Clinton, NJ, and by AHRQ/NHLBI (R01 HS/HL11620-01), Bethesda, MD.

Dr. Angus received supplemental grant funding from INO Therapeutics for an NIH-funded grant; grant funding from INO Therapeutics to study the cost-effectiveness of ECMO and inhaled nitric oxide in the treatment of respiratory distress of newborns; and grant funding from Health Process Management for a study resulting in this manuscript. Dr. Clermont received a grant from INO Therapeutics. Mr. Linde-Zwirble received consulting fees from INO Therapeutics. The remaining authors have not disclosed any potential conflicts of interest.

© 2006 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins