Dale M Needham1,2,3, Kristin A Sepulveda1,2, Victor D Dinglas1,2, Caroline M Chessare1,2, Lisa Aronson Friedman1,2, Clifton O Bingham4,5, Alison E Turnbull1,2,6. 1. 1 Outcomes After Critical Illness and Surgery Group. 2. 2 Division of Pulmonary and Critical Care Medicine, School of Medicine. 3. 3 Department of Physical Medicine and Rehabilitation, School of Medicine. 4. 4 Division of Rheumatology, School of Medicine. 5. 5 Division of Allergy and Clinical Immunology, School of Medicine, and. 6. 6 Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.
Abstract
RATIONALE: Research evaluating acute respiratory failure (ARF) survivors' outcomes after hospital discharge has substantial heterogeneity in terms of the measurement instruments used, creating barriers to synthesizing study data. OBJECTIVES: To identify a minimum set of core outcome measures that are essential to include in all clinical research studies evaluating ARF survivors after discharge. METHODS: We conducted a three-round modified Delphi consensus process with 77 participants (47% female, 55% outside the United States), including clinical researchers from more than 16 countries across six continents, patients/caregivers, clinicians, and research funders. Participants reviewed standardized information on measure instruments for seven consensus-derived outcomes plus one recommended outcome. MEASUREMENTS AND MAIN RESULTS: Response rates were 91 to 97% across the three rounds. Among 75 measurement instruments evaluated, the following met a priori consensus criteria: EQ-5D and 36-item Short Form Health Survey version 2 (optional) for the "satisfaction with life and personal enjoyment" and "pain" outcomes, and both the Hospital Anxiety and Depression Scale and the Impact of Events Scale-Revised for the "mental health" outcome. No measures reached consensus for the following outcomes: cognition, muscle and/or nerve function, physical function, and pulmonary function. All measures considered for pulmonary function met consensus criteria for exclusion. The following measures did not reach the threshold for consensus but achieved the highest scores for their respective outcomes: the Montreal Cognitive Assessment (cognition), manual muscle testing and handgrip dynamometry (muscle and/or nerve function), and 6-minute-walk test (physical function). CONCLUSIONS: This Core Outcome Measurement Set is recommended for use in all clinical research evaluating ARF survivors after hospital discharge. In the future, researchers should evaluate measures for outcomes not reaching consensus.
RATIONALE: Research evaluating acute respiratory failure (ARF) survivors' outcomes after hospital discharge has substantial heterogeneity in terms of the measurement instruments used, creating barriers to synthesizing study data. OBJECTIVES: To identify a minimum set of core outcome measures that are essential to include in all clinical research studies evaluating ARF survivors after discharge. METHODS: We conducted a three-round modified Delphi consensus process with 77 participants (47% female, 55% outside the United States), including clinical researchers from more than 16 countries across six continents, patients/caregivers, clinicians, and research funders. Participants reviewed standardized information on measure instruments for seven consensus-derived outcomes plus one recommended outcome. MEASUREMENTS AND MAIN RESULTS: Response rates were 91 to 97% across the three rounds. Among 75 measurement instruments evaluated, the following met a priori consensus criteria: EQ-5D and 36-item Short Form Health Survey version 2 (optional) for the "satisfaction with life and personal enjoyment" and "pain" outcomes, and both the Hospital Anxiety and Depression Scale and the Impact of Events Scale-Revised for the "mental health" outcome. No measures reached consensus for the following outcomes: cognition, muscle and/or nerve function, physical function, and pulmonary function. All measures considered for pulmonary function met consensus criteria for exclusion. The following measures did not reach the threshold for consensus but achieved the highest scores for their respective outcomes: the Montreal Cognitive Assessment (cognition), manual muscle testing and handgrip dynamometry (muscle and/or nerve function), and 6-minute-walk test (physical function). CONCLUSIONS: This Core Outcome Measurement Set is recommended for use in all clinical research evaluating ARF survivors after hospital discharge. In the future, researchers should evaluate measures for outcomes not reaching consensus.
Authors: Gordon H Guyatt; Andrew D Oxman; Regina Kunz; David Atkins; Jan Brozek; Gunn Vist; Philip Alderson; Paul Glasziou; Yngve Falck-Ytter; Holger J Schünemann Journal: J Clin Epidemiol Date: 2010-12-30 Impact factor: 6.437
Authors: Gordon H Guyatt; Andrew D Oxman; Gunn E Vist; Regina Kunz; Yngve Falck-Ytter; Pablo Alonso-Coello; Holger J Schünemann Journal: BMJ Date: 2008-04-26
Authors: Kitty S Chan; Lisa Aronson Friedman; Victor D Dinglas; Catherine L Hough; Carl Shanholtz; E Wesley Ely; Peter E Morris; Pedro A Mendez-Tellez; James C Jackson; Ramona O Hopkins; Dale M Needham Journal: Thorax Date: 2017-01-20 Impact factor: 9.139
Authors: Alison E Turnbull; Kristin A Sepulveda; Victor D Dinglas; Caroline M Chessare; Clifton O Bingham; Dale M Needham Journal: Crit Care Med Date: 2017-06 Impact factor: 7.598
Authors: Clifford S Deutschman; Tom Ahrens; Charles B Cairns; Curtis N Sessler; Polly E Parsons Journal: Crit Care Med Date: 2012-01 Impact factor: 7.598
Authors: Ann M Parker; Thiti Sricharoenchai; Sandeep Raparla; Kyle W Schneck; O Joseph Bienvenu; Dale M Needham Journal: Crit Care Med Date: 2015-05 Impact factor: 7.598
Authors: Paula R Williamson; Douglas G Altman; Jane M Blazeby; Mike Clarke; Declan Devane; Elizabeth Gargon; Peter Tugwell Journal: Trials Date: 2012-08-06 Impact factor: 2.279
Authors: Cecilia A C Prinsen; Sunita Vohra; Michael R Rose; Maarten Boers; Peter Tugwell; Mike Clarke; Paula R Williamson; Caroline B Terwee Journal: Trials Date: 2016-09-13 Impact factor: 2.279
Authors: Carla M Sevin; Sarah L Bloom; James C Jackson; Li Wang; E Wesley Ely; Joanna L Stollings Journal: J Crit Care Date: 2018-08 Impact factor: 3.425
Authors: O Joseph Bienvenu; Lisa Aronson Friedman; Elizabeth Colantuoni; Victor D Dinglas; Kristin A Sepulveda; Pedro Mendez-Tellez; Carl Shanholz; Peter J Pronovost; Dale M Needham Journal: Intensive Care Med Date: 2017-12-26 Impact factor: 17.440
Authors: Paul R Mouncey; Alvin Richards-Belle; Karen Thomas; David A Harrison; M Zia Sadique; Richard D Grieve; Julie Camsooksai; Robert Darnell; Anthony C Gordon; Doreen Henry; Nicholas Hudson; Alexina J Mason; Michelle Saull; Chris Whitman; J Duncan Young; François Lamontagne; Kathryn M Rowan Journal: Health Technol Assess Date: 2021-02 Impact factor: 4.014
Authors: Stefannie Vorona; Umberto Sabatini; Sulaiman Al-Maqbali; Michele Bertoni; Martin Dres; Bernie Bissett; Frank Van Haren; A Daniel Martin; Cristian Urrea; Debbie Brace; Matteo Parotto; Margaret S Herridge; Neill K J Adhikari; Eddy Fan; Luana T Melo; W Darlene Reid; Laurent J Brochard; Niall D Ferguson; Ewan C Goligher Journal: Ann Am Thorac Soc Date: 2018-06
Authors: Archana Nelliot; Victor D Dinglas; Jacqueline O'Toole; Yashika Patel; Pedro A Mendez-Tellez; Mohammed Nabeel; Lisa Aronson Friedman; Catherine L Hough; Ramona O Hopkins; Michelle N Eakin; Dale M Needham Journal: Ann Am Thorac Soc Date: 2019-06
Authors: Christian König; Bastian Matt; Andreas Kortgen; Alison E Turnbull; Christiane S Hartog Journal: Qual Life Res Date: 2018-10-22 Impact factor: 4.147