Alison E Turnbull1, Kristin A Sepulveda, Victor D Dinglas, Caroline M Chessare, Clifton O Bingham, Dale M Needham. 1. 1Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD. 2Division of Pulmonary and Critical Care Medicine, Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD. 3Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD. 4Divisions of Rheumatology and Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University, Baltimore, MD. 5Department of Physical Medicine and Rehabilitation, School of Medicine, Johns Hopkins University, Baltimore, MD.
Abstract
OBJECTIVES: To identify the "core domains" (i.e., patient outcomes, health-related conditions, or aspects of health) that relevant stakeholders 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 postdischarge 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.
OBJECTIVES: To identify the "core domains" (i.e., patient outcomes, health-related conditions, or aspects of health) that relevant stakeholders 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 postdischarge 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.
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: Dale M Needham; Judy Davidson; Henry Cohen; Ramona O Hopkins; Craig Weinert; Hannah Wunsch; Christine Zawistowski; Anita Bemis-Dougherty; Susan C Berney; O Joseph Bienvenu; Susan L Brady; Martin B Brodsky; Linda Denehy; Doug Elliott; Carl Flatley; Andrea L Harabin; Christina Jones; Deborah Louis; Wendy Meltzer; Sean R Muldoon; Jeffrey B Palmer; Christiane Perme; Marla Robinson; David M Schmidt; Elizabeth Scruth; Gayle R Spill; C Porter Storey; Marta Render; John Votto; Maurene A Harvey Journal: Crit Care Med Date: 2012-02 Impact factor: 7.598
Authors: Alexander A Kon; Judy E Davidson; Wynne Morrison; Marion Danis; Douglas B White Journal: Am J Respir Crit Care Med Date: 2016-06-15 Impact factor: 21.405
Authors: Sohail M Mulla; Amna Maqbool; Laxsanaa Sivananthan; Luciane C Lopes; Stefan Schandelmaier; Mostafa Kamaleldin; Sandy Hsu; John J Riva; Per Olav Vandvik; Ludwig Tsoi; Tommy Lam; Shanil Ebrahim; Bradley C Johnston; Lori Olivieri; Luis Montoya; Regina Kunz; Anne Scheidecker; D Norman Buckley; Daniel I Sessler; Gordon H Guyatt; Jason W Busse Journal: Pain Date: 2015-09 Impact factor: 6.961
Authors: Margaret S Herridge; Angela M Cheung; Catherine M Tansey; Andrea Matte-Martyn; Natalia Diaz-Granados; Fatma Al-Saidi; Andrew B Cooper; Cameron B Guest; C David Mazer; Sangeeta Mehta; Thomas E Stewart; Aiala Barr; Deborah Cook; Arthur S Slutsky Journal: N Engl J Med Date: 2003-02-20 Impact factor: 91.245
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: 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: Dale M Needham; Kristin A Sepulveda; Victor D Dinglas; Caroline M Chessare; Lisa Aronson Friedman; Clifton O Bingham; Alison E Turnbull Journal: Am J Respir Crit Care Med Date: 2017-11-01 Impact factor: 21.405
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
Authors: Hallie C Prescott; Theodore J Iwashyna; Bronagh Blackwood; Thierry Calandra; Linda L Chlan; Karen Choong; Bronwen Connolly; Paul Dark; Luigi Ferrucci; Simon Finfer; Timothy D Girard; Carol Hodgson; Ramona O Hopkins; Catherine L Hough; James C Jackson; Flavia R Machado; John C Marshall; Cheryl Misak; Dale M Needham; Pinaki Panigrahi; Konrad Reinhart; Sachin Yende; Ross Zafonte; Kathryn M Rowan; Derek C Angus Journal: Am J Respir Crit Care Med Date: 2019-10-15 Impact factor: 21.405
Authors: Ericka L Fink; Jessica M Jarvis; Aline B Maddux; Neethi Pinto; Patrick Galyean; Lenora M Olson; Susan Zickmund; Melissa Ringwood; Samuel Sorenson; J Michael Dean; Joseph A Carcillo; Robert A Berg; Athena Zuppa; Murray M Pollack; Kathleen L Meert; Mark W Hall; Anil Sapru; Patrick S McQuillen; Peter M Mourani; R Scott Watson Journal: Contemp Clin Trials Date: 2020-03-05 Impact factor: 2.226