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Dr Bronagh Blackwood, Queen’s University BelfastPresident, European federation of Critical Care Nursing associations
Core outcome sets for critical care researchUKCCRF 2015
Objectives
• What are core outcome sets (COS)?
• Why do we need them?
• Who’s developing them?
• How are they developed & agreed?
• What does it mean for you?
What is a COS?
An agreed, standardized collection of outcomes that should be measured and reported in all trials for a specific clinical area
– small core set of the most important
– does not prevent investigators from measuring other outcomes of interest
Why do we need them?
Chaos: outcome selection; measurement; reporting
Result: research waste
• Threat to the validity of evidence
• Not always patient/clinician relevant
• Impossible to synthesise trial results
• Inability to apply meaningful evidence
• Unethical use of trials
Dogs Dinner!
Not like that! Like that!
Strong recommendations to standardise
• Trial registries, guidelines: CONSORT, WHO, SPIRIT 2013:– specific measurement variable– participant-level analysis metric (e.g. change from baseline,
final value, time to event) – method of aggregation (e.g. proportion, mean) – time frame for each outcome measure
• Critical care organisations: ESICM, ATS, SCCM, ISF, NHLB
• InFACT is biting the bullet
Who’s developing them?
• Not new– The Outcome Measures in Rheumatoid Arthritis Clinical
Trials (OMERACT) Group
• Their success followed by other groups– Maternity care
– Childhood asthma
– Otitis media
– Ulcerative colitis
• Core Outcome Measures in Effectiveness Trials (COMET) repository
COMET (www.comet-initiative.org)
Disease Category (537 matches) 8 Sept 2014
…and COS in critical care?
• Ventilation trials: to reduce duration of MV including early identification of weaning, structured weaning, reducing/weaning sedation (Blackwood/McAuley/Ringrow 2012)
• Cardiac arrest trials: what should be recorded and how (Perkins/Haywood/Whitehead 2012)
• Rehabilitation trials: following critical illness (Connolly/Hart 2013)
• Long-term patient outcomes: for ALI/ARF trials (Needham 2013)• Epi/pandemic studies: of severe acute respiratory infection
(Semple/Sinha 2014)
• Early phase II trials: MV patients (Blackwood/McAuley/Verghis 2015)
• PROPOSED – Aneurysmal SAH (Finfer)• PROPOSED – Sedation/Delirium (Rose/Page)• PROPOSED – Sepsis (Gordon)
How are they being developed?
• Conceptual Frameworks (n=6)
• Many not using framework – validity?
• No framework yet confirmed for critical care – but generally follow the OMERACT model
OMERACT Model
Concepts Health Pathophysiology
OMERACT Model
Concepts Health Pathophysiology
Core Areas Death Life Impact Resource Use Pathophysiology
OMERACT Model
Concepts Health Pathophysiology
Core Areas Death Life Impact Resource Use Pathophysiology
Step 1: Domains of interest (what to measure)‐ systematic review for list of outcomes generally measured in the trials for which the COS
is aimed & undertake a Delphi (or other method) to determine what to measure
OMERACT Model
Concepts Health Pathophysiology
Core Areas Death Life Impact Resource Use Pathophysiology
Core Domain Set Core domain Core domain Core domain Core domain
Step 1: Domains of interest (what to measure)‐ systematic review for list of outcomes generally measured in the trials for which the COS
is aimed & undertake a Delphi (or other method) to determine what to measure
OMERACT Model
Concepts Health Pathophysiology
Core Areas Death Life Impact Resource Use Pathophysiology
Core Domain Set Core domain Core domain Core domain Core domain
Step 1: Domains of interest (what to measure)‐ systematic review for list of outcomes generally measured in the trials for which the COS
is aimed & undertake a Delphi (or other method) to determine what to measure
Step 2: Outcome Measures (how to measure)‐ systematic review for list of outcome measures for each core domain & undertake a
Delphi (or other method) to determine how to measure
OMERACT Model
Concepts Health Pathophysiology
Core Areas Death Life Impact Resource Use Pathophysiology
Core Domain Set Core domain Core domain Core domain Core domain
Core Outcome Measure Set
Core outcome measure
Core outcome measure
Core outcome measure
Core outcome measure
Step 1: Domains of interest (what to measure)‐ systematic review for list of outcomes generally measured in the trials for which the COS
is aimed & undertake a Delphi (or other method) to determine what to measure
Step 2: Outcome Measures (how to measure)‐ systematic review for list of outcome measures for each core domain & undertake a
Delphi (or other method) to determine how to measure
What does it mean for you?
• Trial investigators / systematic reviewers– Protocol stage – include COS (if available)
– Search the COMET database (www.comet-initiative.org)
– Contact CTGs or InFACT for advice (www.infactglobal.org)
What does it mean for you?
• COS development– Get involved. Give your support to COS
development - your opinions are important
– If you want to develop a critical care COS - contact the InFACT Outcome Measures Working Group for specific advice (John Marshall – Chair or myself, Danny McAuley, Kathy Rowan)
