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

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.

[1]  D. Needham,et al.  A systematic review finds limited data on measurement properties of instruments measuring outcomes in adult intensive care unit survivors. , 2017, Journal of clinical epidemiology.

[2]  D. Needham,et al.  Aligning critical care interventions with patient goals: A modified Delphi study. , 2016, Heart & lung : the journal of critical care.

[3]  D. Needham,et al.  Surviving critical illness: what is next? An expert consensus statement on physical rehabilitation after hospital discharge , 2016, Critical Care.

[4]  Jane M Blazeby,et al.  ORAL PRESENTATIONS , 1993, European Surgical Research.

[5]  Caroline B. Terwee,et al.  How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline , 2016, Trials.

[6]  D. Needham,et al.  Outcome Measurement in ICU Survivorship Research From 1970 to 2013: A Scoping Review of 425 Publications* , 2016, Critical care medicine.

[7]  D. White,et al.  Shared Decision-Making in Intensive Care Units. Executive Summary of the American College of Critical Care Medicine and American Thoracic Society Policy Statement. , 2016, American journal of respiratory and critical care medicine.

[8]  D. Needham,et al.  Psychiatric Symptoms in Acute Respiratory Distress Syndrome Survivors: A 1-Year National Multicenter Study , 2016, Critical care medicine.

[9]  C. Becker,et al.  Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention , 2016, Trials.

[10]  D. Altman,et al.  Improving the relevance and consistency of outcomes in comparative effectiveness research. , 2016, Journal of comparative effectiveness research.

[11]  G. Saade,et al.  A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth , 2016, Obstetrics and gynecology.

[12]  Mary G. George,et al.  An International Standard Set of Patient-Centered Outcome Measures After Stroke , 2015, Journal of the Neurological Sciences.

[13]  C. van Walraven,et al.  Competing risk bias was common in Kaplan-Meier risk estimates published in prominent medical journals. , 2016, Journal of clinical epidemiology.

[14]  G. Guyatt,et al.  Reporting of IMMPACT-recommended core outcome domains among trials assessing opioids for chronic non-cancer pain , 2015, Pain.

[15]  P. Hall,et al.  The Importance of Integration of Stakeholder Views in Core Outcome Set Development: Otitis Media with Effusion in Children with Cleft Palate , 2015, PloS one.

[16]  P. Pronovost,et al.  Health care resource use and costs of two-year survivors of acute lung injury. An observational cohort study. , 2015, Annals of the American Thoracic Society.

[17]  S. Patman,et al.  Developing minimum clinical standards for physiotherapy in South African intensive care units: the nominal group technique in action. , 2015, Journal of evaluation in clinical practice.

[18]  D. Altman,et al.  Choosing Important Health Outcomes For Comparative Effectiveness Research: A Systematic Review. , 2014, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[19]  Martin Schumacher,et al.  Interpreting and comparing risks in the presence of competing events , 2014, BMJ : British Medical Journal.

[20]  P. Tugwell,et al.  Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. , 2014, Journal of clinical epidemiology.

[21]  D. Needham.  Understanding and improving clinical trial outcome measures in acute respiratory failure. , 2014, American journal of respiratory and critical care medicine.

[22]  P. Pronovost,et al.  Physical Complications in Acute Lung Injury Survivors: A Two-Year Longitudinal Prospective Study , 2014, Critical care medicine.

[23]  D. van Dijk.  Long-term cognitive impairment after critical illness. , 2014, The New England journal of medicine.

[24]  C. Goss,et al.  An official American Thoracic Society research statement: comparative effectiveness research in pulmonary, critical care, and sleep medicine. , 2013, American journal of respiratory and critical care medicine.

[25]  G. Bernard,et al.  Long-term cognitive impairment after critical illness. , 2013, The New England journal of medicine.

[26]  William A Knaus,et al.  Changes in hospital mortality for United States intensive care unit admissions from 1988 to 2012 , 2013, Critical Care.

[27]  Jane M Blazeby,et al.  Developing core outcome sets for clinical trials: issues to consider , 2012, Trials.

[28]  A. Boonen,et al.  Identifying core domains to assess flare in rheumatoid arthritis: an OMERACT international patient and provider combined Delphi consensus , 2012, Annals of the rheumatic diseases.

[29]  D. Needham,et al.  Improving long-term outcomes after discharge from intensive care unit: Report from a stakeholders' conference* , 2012, Critical care medicine.

[30]  C. Deutschman,et al.  Multisociety Task Force for Critical Care Research: Key issues and recommendations* , 2012, Critical care medicine.

[31]  H. Schünemann,et al.  [GRADE guidelines: 2. Framing the question and deciding on important outcomes]. , 2012, Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen.

[32]  T. Lieu,et al.  Comparative effectiveness research in lung diseases and sleep disorders: recommendations from the National Heart, Lung, and Blood Institute workshop. , 2011, American journal of respiratory and critical care medicine.

[33]  Daniel J Buysse,et al.  The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. , 2010, Journal of clinical epidemiology.

[34]  D. Needham,et al.  Beyond mortality: future clinical research in acute lung injury. , 2010, American journal of respiratory and critical care medicine.

[35]  Douglas G Altman,et al.  The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews , 2010, BMJ : British Medical Journal.

[36]  J. Vincent,et al.  Improving clinical trials in the critically ill , 2010, Critical care medicine.

[37]  J. Ioannidis,et al.  Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias , 2008, PloS one.

[38]  Gordon H Guyatt,et al.  GrADe : what is “ quality of evidence ” and why is it important to clinicians ? rATING quALITY of evIDeNCe AND STreNGTH of reCommeNDATIoNS , 2022 .

[39]  Mike Clarke,et al.  Standardising outcomes for clinical trials and systematic reviews , 2007, Trials.

[40]  Julie F Pallant,et al.  Use of the International Classification of Functioning, Disability and Health (ICF) to identify preliminary comprehensive and brief core sets for multiple sclerosis , 2007, Disability and rehabilitation.

[41]  Arthur S Slutsky,et al.  One-year outcomes in survivors of the acute respiratory distress syndrome. , 2003, The New England journal of medicine.

[42]  D. Angus,et al.  Surviving Intensive Care: a report from the 2002 Brussels Roundtable , 2003, Intensive Care Medicine.

[43]  N. Dalkey,et al.  An Experimental Application of the Delphi Method to the Use of Experts , 1963 .