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