Peer Reviewed

1

Document Type

Article

Publication Date

22-7-2019

Keywords

Core domain set, Core outcome set, Pressure ulcer, Prevention, Scoping review, Delphi, Patient reported outcome, Clinical trial, Dermatology, Service user involvement.

Funder/Sponsor

An international University of Leeds Cheney Fellowship and the European Pressure Ulcer Advisory Panel Research Committee have approved funding to facilitate protocol development, scoping review and face-to-face meetings of collaborators of the OUTPUTS project.

Comments

The original article is available at www.biomedcentral.com

Abstract

BACKGROUND: Core outcome sets (COS) are being developed in many clinical areas to increase the quality and comparability of clinical trial results as well as to ensure their relevance for patients. A COS represents an agreed standardized set of outcomes that describes the minimum that should be consistently reported in all clinical trials of a defined area. It comprises a core domain set (defining what core outcomes should be measured) and a core measurement set (defining measurement/assessment instruments for each core domain). For pressure ulcer prevention trials a COS is lacking. The great heterogeneity of reported outcomes in this field indicates the need for a COS.

METHODS/DESIGN: The first part of this project aims to develop a core domain set by following established methods, which incorporates four steps: (1) definition of the scope, (2) conducting a scoping review, (3) organizing facilitated workshops with service users, (4) performing Delphi surveys and establishing consensus in a face-to-face meeting with different stakeholders.

DISCUSSION: After achieving consensus on the core domain set, further work will be undertaken to determine a corresponding core measurement set. This will lead to better pressure ulcer prevention research in the future. There are a number of methodological challenges in the field of COS development. To meet these challenges and to ensure a high-quality COS, the OUTPUTS project affiliates to current standards and works in close collaboration with international experts and with existing international service user groups.

TRIAL REGISTRATION: The OUTPUTs project is registered in the COMET database: ( http://www.comet-initiative.org/studies/details/283 ). Registered on 2015.

Disciplines

Nursing Midwifery

Citation

Lechner A, Kottner J, Coleman S, Muir D, Bagley H, Beeckman D, Chaboyer W, Cuddigan J, Moore Z, Rutherford C, Schmitt J, Nixon J, Balzer K. Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions. Trails. 2019;20(1):449.

PubMed ID

31331366

DOI Link

10.1186/s13063-019-3543-9

Creative Commons License

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.

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