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Outcomes for Pressure Ulcer Trials (OUTPUTs) project: review and classification of outcomes reported in pressure ulcer prevention research.

Authors
  • Lechner, A1
  • Kottner, J1, 2
  • Coleman, S3
  • Muir, D3
  • Beeckman, D2, 4, 5, 6
  • Chaboyer, W7
  • Cuddigan, J8
  • Moore, Z9, 10, 11, 12, 13
  • Rutherford, C14, 15
  • Schmitt, J16
  • Nixon, J3
  • Balzer, K3, 17
  • 1 Charité - Universitätsmedizin Berlin, Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Berlin, Germany. , (Germany)
  • 2 University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium. , (Belgium)
  • 3 Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, UK.
  • 4 School of Health Sciences, Nursing and Midwifery, University of Surrey, Guildford, UK.
  • 5 School of Nursing and Midwifery, Royal College of Surgeons in Ireland, Faculty of Medicine and Health Sciences, Dublin, Ireland. , (Ireland)
  • 6 School of Health Sciences, Örebro University, Örebro, Sweden. , (Sweden)
  • 7 School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University and Gold Coast Hospital and Health Service, Southport, QLD, Australia. , (Australia)
  • 8 University of Nebraska Medical Center, College of Nursing, Omaha, NE, USA.
  • 9 Royal College of Surgeons in Ireland, Dublin, Ireland. , (Ireland)
  • 10 Monash University, Melbourne, VIC, Australia. , (Australia)
  • 11 Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium. , (Belgium)
  • 12 Lida Institute, Shanghai, China. , (China)
  • 13 Cardiff University, Cardiff, UK.
  • 14 Faculty of Science, Quality of Life Office, School of Psychology, University of Sydney, Sydney, NSW, Australia. , (Australia)
  • 15 Faculty of Medicine and Health, Susan Wakil School of Nursing and Midwifery, Cancer Nursing Research Unit (CNRU), University of Sydney, Sydney, NSW, Australia. , (Australia)
  • 16 Centre for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, Technical University Dresden, Dresden, Germany. , (Germany)
  • 17 Institute for Social Medicine and Epidemiology, Nursing Research Unit, University of Lübeck, Lübeck, Germany. , (Germany)
Type
Published Article
Journal
British Journal of Dermatology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Apr 01, 2021
Volume
184
Issue
4
Pages
617–626
Identifiers
DOI: 10.1111/bjd.19304
PMID: 32510579
Source
Medline
Language
English
License
Unknown

Abstract

In order to overcome inconsistencies in the reporting of outcomes in clinical trials, core outcome sets (COSs) have been developed in many clinical areas and the awareness of this concept is growing steadily. The Outcomes for Pressure Ulcer Trials (OUTPUTs) project aims to improve the quality of evidence from pressure ulcer prevention trials by developing a COS. As an initial step in the COS process we aimed to identify and classify both outcomes and concepts that represent potential outcomes for future trials that have been reported in pressure ulcer prevention research. A review was conducted in 12 major databases covering the literature indexed until 2016. Outcomes and relevant concepts reported in primary studies and/or reviews on pressure ulcer prevention in adult patients were extracted as presented in the articles, and afterwards inductively grouped into outcome domains. The domains were then categorized according to the outcome domain taxonomy recently proposed by the COMET group. In total 332 studies were included and 68 outcome domains were identified, covering multiple aspects of pressure ulcer prevention. Pressure ulcer occurrence was reported in 71% of all included studies, representing the most frequent outcome, followed by costs (22% of all studies) and acceptability of intervention and comfort (18% of all studies). A plethora of different outcomes are applied in pressure ulcer prevention research and substantial variations in definitions and reporting of similar outcomes were observed. A COS for pressure ulcer prevention trials is needed to overcome the noncomparability of outcomes. © 2020 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

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