Core Outcome Measurement Set (COMS)

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. Visit the Core Outcome Set Resources page to locate generic templates and resources to aid researchers interested in implementing a Delphi consensus process.

The first stage of the Delphi consensus process established recommendations for a Core Outcome Set (COS).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 

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The following 8 core outcomes are recommended for evaluation:

  • Survival
  • Satisfaction with Life and  Personal Enjoyment (Health-related quality of life)
  • Mental health
  • Pain
  • Cognition*
  • Physical function**
  • Muscle and/or nerve function**
  • Pulmonary function**

 Click here to download: Infographic summary of COS and COMS

 


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.

Core Measure Set NameMeasurement InstrumentsTotal No. of QuestionsEstimated Time to Complete (minutes)Estimated Cost per Visit
(as of June 2017)
Minimum SetSurvival measure, EQ-5D, HADS, IES-R 4212 minutes$1.50
Minimum + cognitive screeningSurvival measure, EQ-5D, HADS, IES-R, + MoCA5517 minutes$1.50
Minimum + SF-36Survival measure, EQ-5D, HADS, IES-R, + SF-36 v27821 minutes≥$3.00
Minimum + SF-36 + cognitive screeningSurvival measure, EQ-5D, HADS, IES-R, + SF-36 v2 + MoCA9126 minutes≥$3.00

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Click here to download: Infographic of acceptable COMS configurations

 

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 participants via a very brief 6 questions survey.

Please contact improveLTO@jhmi.edu to learn more about this Core Outcome Measurement Set survey for participants and researchers


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)).

Webinars:

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References:

  1. 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;45(6):1001-1010. PubMed
  2. 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;196:1122-1130. PubMed

Helpful links:

  1. Core Outcome Set Resources