Introduction: Core outcome sets (COS) aim to reduce heterogeneity in outcome measurement and reporting. Through the input of key stakeholders, COS also ensure that clinical trials measure outcomes that are relevant to all who make decisions about health care. Standards for COS development exist but allow for variation in the methods used. However, the choice of methods can have important implications for the outcomes included in the core outcome set and subsequent uptake. The aim of this scoping review is to systematically identify and map published methods research in the context COS development and implementation, and to summarise gaps in evidence.
Methods and analysis: A scoping review will be conducted using Joanna Briggs Institute guidance for scoping reviews. Search terms have been developed to identify relevant literature, published from 2010. These search terms will be applied to MEDLINE (Ovid) and CINHAL Ultimate. We will also use forward citation searching for key publications that describe methods for COS development, protocols, and reporting. A team of researchers will screen and extract data with any discrepancies resolved through discussion. Included studies will be those that have asked a methodological question in the context of COS development and implementation.
Ethics and dissemination: Ethical approval is not required for this scoping review. The results of the review will be reported in line with the referred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews (PRISMA-ScR) checklist. The scoping review and resulting evidence map will be reported in an open access publication and in a plain language summary document.
Rachel Knight Lozano, Senior Lecturer, University of Plymouth.
Karen Hughes, Research Associate, University of Liverpool.
Shoba Dawson, Senior Research Fellow, University of Sheffield.
Kirstie L Haywood, Professor of Health Outcomes, University of Warwick.
Sarah Gorst, Senior Research Fellow, University of Liverpool.
Steven MacLennan, Senior Research Fellow, University of Aberdeen.
Christopher Millward, Medical Assessor, Medicines and Healthcare Regulatory Agency.
Julia Melluish, Public Research Partner.
Amanda Roberts, Public Research Partner.
Frances Sherratt, Research Associate, University of Liverpool.
Valerie Smith, Professor in Midwifery, University College Dublin.
Nicola Harman, Senior Lecturer, University of Liverpool (Principal Investigator).
Disease Category: Methodological & diagnostic
Disease Name: N/A
Age Range: Unknown
Sex:
Nature of Intervention:
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Methodologists
- Researchers
- COS methods research
- Systematic review
Scoping review conducted using Joanna Briggs Institute guidance for scoping reviews. Included studies will be those that have asked a methodological question in the context of COS development and implementation.