Core Domains for Clinical Research in Acute Respiratory Failure Survivors: An International Modified Delphi Consensus Study

被引：78

作者：

Turnbull, Alison E. ^{[1
,2
,3
]}

Sepulveda, Kristin A. ^{[1
,2
]}

Dinglas, Victor D. ^{[1
,2
]}

Chessare, Caroline M. ^{[1
,2
]}

Bingham, Clifton O. ^{[4
,5
]}

Needham, Dale M. ^{[1
,2
,6
]}

机构：

[1] Johns Hopkins Univ, OACIS Grp, Baltimore, MD 21218 USA

[2] Johns Hopkins Univ, Sch Med, Dept Med, Div Pulm & Crit Care Med, Baltimore, MD 21205 USA

[3] Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Dept Epidemiol, Baltimore, MD 21218 USA

[4] Johns Hopkins Univ, Dept Med, Div Rheumatol, Baltimore, MD USA

[5] Johns Hopkins Univ, Dept Med, Div Allergy & Clin Immunol, Baltimore, MD USA

[6] Johns Hopkins Univ, Sch Med, Dept Phys Med & Rehabil, Baltimore, MD USA

来源：

CRITICAL CARE MEDICINE | 2017年 / 45卷 / 06期

基金：

美国国家卫生研究院; 英国医学研究理事会;

关键词：

clinical trials; disability evaluation; follow-up studies; intensive care; patient outcome assessment; OUTCOME REPORTING BIAS; INTENSIVE-CARE UNITS; ACUTE LUNG INJURY; SYSTEMATIC REVIEWS; DISTRESS-SYNDROME; CRITICAL ILLNESS; TRIALS; RECOMMENDATIONS; STATEMENT; SETS;

D O I：

10.1097/CCM.0000000000002435

中图分类号：

R4 [临床医学];

学科分类号：

1002 ; 100602 ;

摘要：

Objectives: To identify the "core domains" (i.e., patient outcomes, health-related conditions, or aspects of health) that relevant stake-holders agree are essential to assess in all clinical research studies evaluating the outcomes of acute respiratory failure survivors after hospital discharge. Design: A two-round consensus process, using a modified Delphi methodology, with participants from 16 countries, including patient and caregiver representatives. Prior to voting, participants were asked to review 1) results from surveys of clinical researchers, acute respiratory failure survivors, and caregivers that rated the importance of 19 preliminary outcome domains and 2) results from a qualitative study of acute respiratory failure survivors' outcomes after hospital discharge, as related to the 19 preliminary outcome domains. Participants also were asked to suggest any additional potential domains for evaluation in the first Delphi survey. Setting: Web-based surveys of participants representing four stakeholder groups relevant to clinical research evaluating post discharge outcomes of acute respiratory failure survivors: clinical researchers, clinicians, patients and caregivers, and U.S. federal research funding organizations. Subjects: None. Interventions: None. Measurements and Main Results: Survey response rates were 97% and 99% in round 1 and round 2, respectively. There were seven domains that met the a priori consensus criteria to be designated as core domains: physical function, cognition, mental health, survival, pulmonary function, pain, and muscle and/or nerve function. Conclusions: This study generated a consensus-based list of core domains that should be assessed in all clinical research studies evaluating acute respiratory failure survivors after hospital discharge. Identifying appropriate measurement instruments to assess these core domains is an important next step toward developing a set of core outcome measures for this field of research.

引用

页码：1001 / 1010

页数：10

共 45 条

[1] Surviving intensive care: a report from the 2002 Brussels Roundtable [J].