The Association Between Days Alive and Out of Hospital and Health-Related Quality of Life in Patients With Sepsis
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(Published version)
Date
2023
Authors
Delaney, A.
Tian, D.H.
Higgins, A.
Presneill, J.
Peake, S.
Venkatesh, B.
Myburgh, J.
Finfer, S.
Thompson, K.
Taylor, C.
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CHEST Critical Care, 2023; 1(3):100024-1-100024-12
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Anthony Delaney, David H. Tian, Alisa Higgins, Jeffrey Presneill, Sandra Peake, Balasubramanian Venkatesh, John Myburgh, Simon Finfer, Kelly Thompson, Colman Taylor, Lachlan Donaldson, Joseph A. Santos, and Naomi Hammond
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Abstract
BACKGROUND: The number of days alive and out of hospital (DAOH) is being used as a primary outcome in clinical trials. Limited data support the contention that it is a patientimportant outcome. RESEARCH QUESTION: The primary objective was to assess the association between DAOH and health-related quality of life (HRQoL) at 6 months, as well as to assess the construct validity of DAOH as an outcome measure. STUDY DESIGN AND METHODS: Using data from the Adjunctive Corticosteroid Treatment in Critically Ill Patients With Septic Shock, Australasian Resuscitation in Sepsis Evaluation, and Crystalloid vsHydroxyethyl Starch trials, we calculated the number ofDOAHat day 90 (DAOH- 90). HRQoL was estimated with the EQ-5D utility index score (range, –0.59 to 1) and the EQ-5D visual analog scale (range, 0-100) at 6 months. The association between DAOH and HRQoL was assessed using linear models, nonlinear models, and nonparametric measures of association. RESULTS: Six thousand two hundred thirteen trial participants included. The median index hospital length of stay was 16 days (interquartile range [IQR], 8-30), and mortality for the index hospitalization was 1,402 of 6,213 (22.6%). The median number of DAOH-90 was 60 days (IQR, 0-77 days). Each additional DAOH-90 was associated with an estimated increase in the 6-month EQ-5D utility index (range, 0-1) of 0.01 (95% CI, 0.01-0.011; P < .001). Adjusted analysis showed that each additional DAOH-90 was associated with an increase of 1.01 (95% CI, 0.99-1.04; P < .001) in the EQ-5D visual analog scale (range, 0-100). Trial participants at higher risk of adverse outcomes showed fewer DAOH-90. INTERPRETATION: We found a small positive incremental association between the number of DAOH-90 and HRQoL at 6 months and a negative association between the number of DAOH-90 and risk factors for adverse outcomes. These data provide some support for the use of DAOH-90 as an outcome measure in clinical trials of patients with sepsis. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT04567433; URL: www.clinicaltrials.gov
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Crown Copyright © 2023 Published by Elsevier Inc. under license from the American College of Chest Physicians. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).