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Outcomes for Pressure Ulcer Trials (OUTPUTs)

Condition

Pressure ulcers

Background

Pressure ulcers are lesions of the skin and underlying soft tissues caused by prolonged and/or elevated exposure to compressive and shearing forces. Worldwide, the prevalence of pressure ulcers ranges from 0.3 % to 46%, with highest prevalence in advanced age. PUs can cause symptoms including pain, exudate and odour, and compromise all areas of patient functioning, which consequently reduce quality of life. As pressure ulcers are considered to be largely preventable, their occurrence is widely used as a quality indicator/patient safety parameter. An important outcome of pressure ulcer prevention trials is the measurement of the pressure ulcer occurrence. However, substantial cross-trial variance and within-trial risk of bias have been noted with regard to this outcome measure. Many other outcomes are also reported in prevention trials, such as: pathophysiological changes, including tissue oxygenation and skin barrier changes; patient-reported outcomes including comfort, pain and quality of life; and health resource/economic outcomes. However, there are no agreed standards for which outcomes are of most importance and which measurement instruments, or methods should be favored.

Scope of the intended COS

  • Study types: Intervention trials such as RCTs
  • Global scope, adults 18+ years

Methods

Systematic reviews, service user interviews, Delphi studies, face-to-face meetings

Involvement of stakeholders

Researchers, service users, industry representatives, researchers, clinicians

Current status

The long list of outcomes domains is currently being prepared.

Funding

University of Leeds (UK), Charité-Universitätsmedizin Berlin, European Pressure Ulcer Advisory Panel (EPUAP)

Involved Countries

UK, Germany, Belgium, Australia, United States, Ireland and worldwide during Delphi process

Date of updates

  • 26/08/2019

Lead

  • Dr. Jane Nixon
  • Dr. Jan Kottner

Project team members

  • Anna Lechner
  • Dr. Susanne Coleman
  • Delia Muir
  • Prof. Dr. Katrin Balzer

Responsible member of Methods group (as assigned by CS-COUSIN)

  • Prof. Jamie Kirkham

Contact

  • J.E.Nixon@leeds.ac.uk

Published references

1. 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. Trials. 2019;20(1):449.