Towards a core outcome set for clinical trials in headache (COSH): an international, multi-perspective initiative

Systematic reviews of headache clinical trials, outcome reporting and the quality and acceptability of PROMs used in the headache population – conducted as part of a larger clinical trial (the CHESS study (PI Prof Martin Underwood)) – have highlighted significant heterogeneity in outcome reporting in headache studies, raising concerns over reporting bias and limiting the conduct of systematic reviews and meta-analyses of evidence. An international, multi-stakeholder consensus on the most important outcomes to include in future clinical trials in the headache population – what to assess and how – is required, and will be addressed by the proposed study.

Contributors

Principal investigator - Dr Kirstie Haywood. Royal College of Nursing Research Institute, Warwick Medical School, Warwick University.

Further Study Information

Current Stage: Ongoing
Date: January 2017 - January 2018
Funding source(s): TBC


Health Area

Disease Category: Neurology

Disease Name: Headache, Migraine

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Charities
- Clinical experts
- Consumers (patients)
- Economists
- Methodologists
- Patient/ support group representatives
- Researchers
- Service users

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Literature review
- Nominal group technique (NGT)
- Systematic review

Three key stages are proposed:
1. A comprehensive list of outcomes will be developed to inform questionnaire development for the international e-Delphi.
a. This will be informed by systematic reviews completed as part of the CHESS study.
b. Qualitative research and narrative reviews completed as part of the CHESS study.
c. A long-list of potential outcomes will be considered, mapped onto health domains and discussed with key stakeholders, including patient research partners.
d. A final list of outcomes and domains will inform items for the e-Delphi (stage 2).

2. A three-round international e-Delphi survey is proposed to work towards consensus on the core domain set (CDS).
a. International participants will be identified – to reflect key stakeholders including health professionals, clinicians, patients, clinical academics, researchers.

3. An international, multi-stakeholder consensus meeting (modified nominal group) will be held to confirm the core domain set (CDS) and to achieve consensus on the core outcome measurement set (COMS).

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