Core Outcome Measures in Effectiveness Trials

Developing and agreeing the Life After Stroke Set of Outcomes (LASSO): A core outcome set

General Information

Summary:
There is an urgent need to improve life after stroke. However, the evidence base is undermined by poor and uncoordinated outcome measurement. An agreed and standardised set of essential outcomes (Core Outcome Set (COS)) for use in effectiveness trials is required, informed by knowledge of the outcomes that matter most to stroke survivors, families and other clinical decision makers.

Methods:
Stage I: Identification of outcomes that may be relevant for life after stroke encompassing those used in stroke trials via a systematic review and those discussed by stroke survivors and carers via an overview of qualitative systematic reviews.
Stage II: Agreement of COS via (1) A Q methodology study with stroke survivors and carers to identify their perspectives on priority outcomes (2) A Delphi study with professionals and (3) Final agreement at a consensus conference.
Stage III: Identification of candidate measures for each of the core outcomes via systematic review.

Expected outcomes:
An agreed COS, reflecting the outcomes that matter most to stakeholders, candidate measures for these outcomes and an agenda for further research. The COS should be measured and reported in all relevant effectiveness trials enabling future meta-analysis, an enhanced evidence base and improvement in life after stroke.

Contributors:
Tom Crocker [1]: Chief investigator
Anne Forster [1,2]: Supervisor
David Clarke [1,2]: Supervisor
Janet Holt [3]
Barbara Brown: Consumer expert

1: Academic Unit of Elderly Care & Rehabilitation, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust
2: Academic Unit of Elderly Care & Rehabilitation, Leeds Institute of Health Sciences, University of Leeds
3: School of Healthcare, University of Leeds

Further Study Information

Current Stage:
Planning
Date:
July 2018 - November 2021
Funding source(s):
TBC

Health Area

Disease Category
Neurology

Disease Name
Stroke

Target Population

Age Range
16 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus conference
Delphi process
Literature review
Nominal group technique (NGT)
Other
Systematic review

Other: Q methodology

Stage I: Identification of outcomes that may be relevant for life after stroke encompassing those used in stroke trials via a systematic review and those discussed by stroke survivors and carers via an overview of qualitative systematic reviews.
Stage II: Agreement of COS via (1) A Q methodology study with stroke survivors and carers to identify their perspectives on priority outcomes (2) A Delphi study with professionals and (3) Final agreement at a consensus conference.
Stage III: Identification of candidate measures for each of the core outcomes via systematic review.


Stakeholders Involved

Charities
Clinical experts
Consumers (caregivers)
Consumers (patients)
Researchers
Service commissioners

Study Type

COS for clinical trials or clinical research

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