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
| Autor: | 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 |
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| Rok vydání: | 2019 |
| Předmět: |
core domain set
Scoping review Consensus Delphi Technique Endpoint Determination Medicine (miscellaneous) Dermatology core outcome set Pressure ulcer Delphi Core domain set Study Protocol prevention QUALITY-OF-LIFE Medicine and Health Sciences Humans Pharmacology (medical) lcsh:R5-920 Clinical Trials as Topic pressure ulcer Prevention COST Core outcome set clinical trial CARE FRAMEWORK service user involvement Patient reported outcome Clinical trial patient reported outcome dermatology Treatment Outcome delphi Research Design scoping review lcsh:Medicine (General) CONSENSUS 600 Technik Medizin angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit Service user involvement |
| Zdroj: | Trials TRIALS Trials, Vol 20, Iss 1, Pp 1-9 (2019) |
| ISSN: | 1745-6215 |
| DOI: | 10.17169/refubium-3928 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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