Core outcome sets (COS) are consensus-driven sets of minimum outcomes that should be measured and reported in all clinical trials. COS aim to reduce heterogeneity in outcome measurement and reporting, and selective outcome reporting. Implementing COS into clinical trials is challenging. Guidance to improve COS uptake in dermatology is lacking.
To develop a structured practical guide to COS implementation.
Members of the Harmonising Outcome Measurement for Eczema (HOME) executive committee developed an expert opinion-based roadmap founded on a combination of a review of the COS implementation literature, the Core Outcome Measures in Effectiveness Trials (COMET) initiative resources, input from HOME members and experience in COS development and clinical trials.
The data review and input from HOME members was synthesized into themes, which guided roadmap development: (a) barriers and facilitators to COS uptake based on stakeholder awareness/engagement and COS features; and (b) key implementation science principles (assessment-driven, data-centred, priority-based and context-sensitive). The HOME implementation roadmap follows three stages. Firstly, the COS uptake scope and goals need to be defined. Secondly, during COS development, preparation for future implementation is supported by establishing the COS as a credible evidence-informed consensus by applying robust COS development methodology, engaging multiple stakeholders, fostering sustained and global engagement, emphasizing COS ease of use and universal applicability, and providing recommendations on COS use. Thirdly, incorporating completed COS into primary (trials) and secondary (reviews) research is an iterative process starting with mapping COS uptake and stakeholders’ attitudes, followed by designing and carrying out targeted implementation projects. Main themes for implementation projects identified at HOME are stakeholder awareness/engagement; universal applicability for different populations; and improving ease-of-use by reducing administrative and study burden. Formal implementation frameworks can be used to identify implementation barriers/facilitators and to design implementation strategies. The effect of these strategies on uptake should be evaluated and implementation plans adjusted accordingly.
COS can improve the quality and applicability of research and, so, clinical practice but can only succeed if used and reported consistently. The HOME implementation roadmap is an extension of the original HOME roadmap for COS development and provides a pragmatic framework to develop COS implementation strategies.
To develop a structured practical guide to COS implementation.Contributors
Yael A Leshem, Eric L Simpson, Christian Apfelbacher, Phyllis I Spuls, Kim S Thomas, Jochen Schmitt, Laura Howells, Louise A A Gerbens, Michael E Jacobson, Norito Katoh, Hywel C Williams, on behalf of the Harmonising Outcome Measures for Eczema (HOME) initiative
- COS methods research
- Semi structured discussion
- Systematic review
The roadmap was developed as follows: (i) a selective PubMed search for publications on ‘COS implementation’ and ‘COS uptake’ was performed in December 2021, with key papers extracted. The reference list of a comprehensive 2022 review on COS implementation was reviewed for additional papers. Additionally, we conducted an online search for websites with implementation resources and of the Core Outcome Measures in Effectiveness Trials
(COMET) initiative website.3 (ii) At the HOME IX (virtual, 2020)17 and X (Montreal, 2021) multistakeholder meetings, HOME members identified HOME-specific implementation
barriers and facilitators, and developed preliminary implementation strategies. (iii) Opportunities for influencing COS uptake were then mapped throughout the course of a clinical trial and its subsequent use in systematic reviews and
guidelines (Figure 1). (iv) The data were integrated into the HOME implementation roadmap based on expert opinion. The roadmap was structured to follow the COS life cycle,
guiding implementation efforts for each phase.