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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

Authors
  • Lechner, Anna1
  • Kottner, Jan1, 2
  • Coleman, Susanne3
  • Muir, Delia3
  • Bagley, Heather4
  • Beeckman, Dimitri2, 5, 6, 7
  • Chaboyer, Wendy8
  • Cuddigan, Janet9
  • Moore, Zena10, 11, 12, 13, 14
  • Rutherford, Claudia15, 16
  • Schmitt, Jochen17
  • Nixon, Jane3
  • Balzer, Katrin18, 3
  • 1 Charité – Universitätsmedizin Berlin, Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charitéplatz 1, Berlin, 10117, Germany , Berlin (Germany)
  • 2 University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium , Ghent (Belgium)
  • 3 University of Leeds, Institute of Clinical Trials Research, Clinical Trials Research Unit, Leeds, UK , Leeds (United Kingdom)
  • 4 University of Liverpool, Clinical Trials Research Centre (CTRC), North West Hub for Trials Methodology, Liverpool, UK , Liverpool (United Kingdom)
  • 5 University of Surrey, School of Health Sciences, Nursing and Midwifery, Guildford, UK , Guildford (United Kingdom)
  • 6 Royal College of Surgeons in Ireland, School of Nursing and Midwifery, Dublin, Ireland , Dublin (Ireland)
  • 7 Örebro University, School of Health Sciences, Örebro, Sweden , Örebro (Sweden)
  • 8 Griffith University and Gold Coast Hospital and Health Service, School of Nursing & Midwifery, Menzies Health Institute Queensland, Southport, Qld, Australia , Southport (Australia)
  • 9 University of Nebraska Medical Center, College of Nursing, Omaha, NE, USA , Omaha (United States)
  • 10 Royal College of Surgeons in Ireland, Dublin, Ireland , Dublin (Ireland)
  • 11 Monash University, Melbourne, Australia , Melbourne (Australia)
  • 12 Ghent University, Faculty of Medicine and Health Sciences, Ghent, Belgium , Ghent (Belgium)
  • 13 Lida Institute, Shanghai, China , Shanghai (China)
  • 14 Cardiff University, Cardiff, Wales , Cardiff (United Kingdom)
  • 15 University of Sydney, Faculty of Science, Quality of Life Office, School of Psychology, Sydney, Australia , Sydney (Australia)
  • 16 University of Sydney, Sydney Nursing School, Cancer Nursing Research Unit (CNRU), Sydney, Australia , Sydney (Australia)
  • 17 Technical University Dresden, Centre for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, Dresden, Germany , Dresden (Germany)
  • 18 University of Lübeck, Institute for Social Medicine and Epidemiology, Nursing Research Unit, Lübeck, Germany , Lübeck (Germany)
Type
Published Article
Journal
Trials
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Jul 22, 2019
Volume
20
Issue
1
Identifiers
DOI: 10.1186/s13063-019-3543-9
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundCore 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/designThe 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.DiscussionAfter 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 registrationThe OUTPUTs project is registered in the COMET database: (http://www.comet-initiative.org/studies/details/283). Registered on 2015.

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