Anthony Delaney PhD , David H. Tian PhD , Alisa Higgins PhD , Jeffrey Presneill PhD , Sandra Peake PhD , Balasubramanian Venkatesh MD , John Myburgh PhD , Simon Finfer DrMed , Kelly Thompson PhD , Colman Taylor PhD , Lachlan Donaldson MD , Joseph A. Santos PhD , Naomi Hammond PhD
{"title":"脓毒症患者院外存活天数与健康相关生活质量的关系","authors":"Anthony Delaney PhD , David H. Tian PhD , Alisa Higgins PhD , Jeffrey Presneill PhD , Sandra Peake PhD , Balasubramanian Venkatesh MD , John Myburgh PhD , Simon Finfer DrMed , Kelly Thompson PhD , Colman Taylor PhD , Lachlan Donaldson MD , Joseph A. Santos PhD , Naomi Hammond PhD","doi":"10.1016/j.chstcc.2023.100024","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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 patient-important outcome.</p></div><div><h3>Research Question</h3><p>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.</p></div><div><h3>Study Design and Methods</h3><p>Using data from the Adjunctive Corticosteroid Treatment in Critically Ill Patients With Septic Shock, Australasian Resuscitation in Sepsis Evaluation, and Crystalloid vs Hydroxyethyl Starch trials, we calculated the number of DOAH at 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.</p></div><div><h3>Results</h3><p>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; <em>P</em> < .001). Adjusted analysis showed that each additional DAOH-90 was associated with an increase of 1.01 (95% CI, 0.99-1.04; <em>P</em> < .001) in the EQ-5D visual analog scale (range, 0-100). Trial participants at higher risk of adverse outcomes showed fewer DAOH-90.</p></div><div><h3>Interpretation</h3><p>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.</p></div><div><h3>Trial Registry</h3><p>ClinicalTrials.gov; No.: NCT04567433; URL: <span>www.clinicaltrials.gov</span><svg><path></path></svg></p></div>","PeriodicalId":93934,"journal":{"name":"CHEST critical care","volume":"1 3","pages":"Article 100024"},"PeriodicalIF":0.0000,"publicationDate":"2023-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2949788423000242/pdfft?md5=dfac849a8d3a03431c38f3f9098fc8c2&pid=1-s2.0-S2949788423000242-main.pdf","citationCount":"0","resultStr":"{\"title\":\"The Association Between Days Alive and Out of Hospital and Health-Related Quality of Life in Patients With Sepsis\",\"authors\":\"Anthony Delaney PhD , David H. Tian PhD , Alisa Higgins PhD , Jeffrey Presneill PhD , Sandra Peake PhD , Balasubramanian Venkatesh MD , John Myburgh PhD , Simon Finfer DrMed , Kelly Thompson PhD , Colman Taylor PhD , Lachlan Donaldson MD , Joseph A. Santos PhD , Naomi Hammond PhD\",\"doi\":\"10.1016/j.chstcc.2023.100024\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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 patient-important outcome.</p></div><div><h3>Research Question</h3><p>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.</p></div><div><h3>Study Design and Methods</h3><p>Using data from the Adjunctive Corticosteroid Treatment in Critically Ill Patients With Septic Shock, Australasian Resuscitation in Sepsis Evaluation, and Crystalloid vs Hydroxyethyl Starch trials, we calculated the number of DOAH at 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.</p></div><div><h3>Results</h3><p>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; <em>P</em> < .001). Adjusted analysis showed that each additional DAOH-90 was associated with an increase of 1.01 (95% CI, 0.99-1.04; <em>P</em> < .001) in the EQ-5D visual analog scale (range, 0-100). Trial participants at higher risk of adverse outcomes showed fewer DAOH-90.</p></div><div><h3>Interpretation</h3><p>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.</p></div><div><h3>Trial Registry</h3><p>ClinicalTrials.gov; No.: NCT04567433; URL: <span>www.clinicaltrials.gov</span><svg><path></path></svg></p></div>\",\"PeriodicalId\":93934,\"journal\":{\"name\":\"CHEST critical care\",\"volume\":\"1 3\",\"pages\":\"Article 100024\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-10-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2949788423000242/pdfft?md5=dfac849a8d3a03431c38f3f9098fc8c2&pid=1-s2.0-S2949788423000242-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"CHEST critical care\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2949788423000242\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"CHEST critical care","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2949788423000242","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
The Association Between Days Alive and Out of Hospital and Health-Related Quality of Life in Patients With Sepsis
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 patient-important 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 vs Hydroxyethyl Starch trials, we calculated the number of DOAH at 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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
