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Design considerations in the development of a core outcome set

No gold standard method currently exists for the development of a core outcome set (COS) although key issues to consider have been identified [1]. Methodological decisions in the design of a project to develop a COS for otitis media with effusion (OME) in children with cleft palate (CP) will be explained.

Stakeholder groups

Clinicians involved in the management of OME were identified as: ENT surgeons; audiologists; cleft surgeons; speech and language therapists; specialist nurses. Discussions with CLAPA patient groups resulted in a Delphi for patients (7-11, 12-16 years), their parents and adults with CP and OME.

Separate Delphi panels

A Delphi exercise has been undertaken with each clinical stakeholder group separately. This method does not assume that different stakeholder groups will have the same outcome priorities.

Describing outcomes for patients and their parents

A lay description written for each outcome was reviewed by CLAPA groups and reading age assessed. Understanding was tested in a subsample using the think aloud method.

Delivery of the Delphi online

Each round of the Delphi was delivered online using a bespoke system that managed participation invitations , reminders, data collection and reporting.

Integration of clinical and patient views

Results of the separate Delphi surveys for each stakeholder group will be shared with all participants with an opportunity to re-score. Clinicians, adults, patients and their parents who have taken part in a Delphi panel/qualitative interview will be invited to a consensus meeting, facilitated by a Study Advisory Group and CLAPA members, to discuss the final COS.


  1. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Tugwell P: Developing core outcome sets for clinical trials: issues to consider. Trials. 2012, 13: 132-10.1186/1745-6215-13-132.

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This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Harman, N., Bruce, I., Callery, P. et al. Design considerations in the development of a core outcome set. Trials 14 (Suppl 1), O68 (2013).

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