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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
Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité – Universitätsmedizin Berlin, Berlin, Germany.
Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité – Universitätsmedizin Berlin, Berlin, Germany; University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium.
Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, UK.
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2019 (English)In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, article id 449Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
BMC , 2019. Vol. 20, article id 449
Keywords [en]
Core domain set, Core outcome set, Pressure ulcer, Prevention, Scoping review, Delphi, Patient reported outcome, Clinical trial, Dermatology, Service user involvement
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
URN: urn:nbn:se:oru:diva-75723DOI: 10.1186/s13063-019-3543-9ISI: 000476844400001PubMedID: 31331366Scopus ID: 2-s2.0-85069790919OAI: oai:DiVA.org:oru-75723DiVA, id: diva2:1342592
Note

Funding Agencies:

International University of Leeds Cheney Fellowship  

European Pressure Ulcer Advisory Panel Research Committee  

Available from: 2019-08-14 Created: 2019-08-14 Last updated: 2019-08-14Bibliographically approved

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Beeckman, Dimitri

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