Core Outcome Measurement Set
Aim 1 of this project includes creation of a minimum set of outcomes and associated measurement instruments for use in all clinical research studies that are planning to evaluate acute respiratory failure/acute respiratory distress syndrome (ARF/ARDS) survivors after hospital discharge.
A 2-stage modified Delphi consensus process was conducted with representatives from relevant stakeholder groups, including: (1) clinical researchers from >16 countries from 6 continents, (2) clinicians from US, Canada, UK, and Australia, (3) ICU survivors/caregivers from US, Canada, UK, and Australia, and (4) representatives of US federal funding bodies. For more information about the process, please see: Modified Delphi Consensus Protocol.
The first stage of the Delphi consensus process established recommendations for a Core Outcome Set.1 Core outcomes are defined as patient outcomes, health-related conditions, or aspects of health, that are essential to evaluate in all studies within a specific clinical field.2,3 The following 8 core outcomes are recommended for evaluation:
- Satisfaction with Life and Personal Enjoyment (Health-related quality of life)
- Mental health
- Physical function**
- Muscle and/or nerve function**
- Pulmonary function**
The second stage of the Delphi process established a Core Outcome Measurement Set of recommended measurement instruments for the Core Outcomes Set.4 We summarized acceptable configurations of the Core Outcome Measurement Set below.
- Click here: Downloadable summary of the Core Outcome Measurement Set
- Click here: Example publications and study protocols that report all components of the Core Outcome Measurement Set
A summary of information for each outcome measure included in the Core Outcome Measure Set is available below.For more information about each measure, please log-in to the website to access more FREE information about the Core Outcome Measure Set. (Login / Register)
NOTE: If you implement this Core Outcome Measurement Set, we request that you also obtain feedback from patients and research staff via a very brief <10 questions survey. Please contact improveLTO@jhmi.edu to learn more about this Core Outcome Measurement Set survey.
- Click here: Core Outcome Measurement Set User Survey
For more information or questions, contact ImproveLTO@jhmi.edu.
*Although there was no consensus on a cognition measurement instrument, the Montreal Cognitive Assessment (MoCA) received the highest rating and has a version (i.e., MoCA-BLIND) that can be done via phone, like the rest of the Core Outcome Measurement Set; therefore, we encourage inclusion of this instrument in the Core Outcome Measurement Set.
** There was no consensus on measurement instruments to include for these outcomes. However, if in-person assessments are part of a research protocol, the following tests received the highest scores from the Delphi panel: Physical Function (6-Minute Walk Test); Muscle and/or Nerve Function (Manual Muscle Test and Hand-Grip Strength); and Pulmonary Function (panel voted to exclude all tests that were considered (e.g., spirometry, St. George’s Respiratory Questionnaire)).
- Turnbull AE, Sepulveda KA, Dinglas VD, Bingham CO, Needham, DM. Core domains for clinical research in acute respiratory failure survivors: an international modified Delphi consensus study. Critical Care Medicine 2017; ePub. PubMed
- Clarke M: Standardising outcomes for clinical trials and systematic reviews. Trials 2007; 8:39
- Williamson PR, Altman DG, Blazeby JM, et al.: Developing core outcome sets for clinical trials: issues to consider. Trials 2012; 13:132
- Needham DM, Sepulveda KA, Dinglas VD, Chessare CM, Friedman LA, Bingham III CO, Turnbull AE. Core outcome measures for clinical research in acute respiratory failure survivors: an international modified Delphi consensus study. Am J Respir Crit Care Med. 2017. In press.
- COMET (Core Outcome Measures in Effectiveness Trials) Initiative
- The COMET Handbook: version 1.0 (Guidelines for developing and implementing a core outcome set)