Pressure ulcers/injuries are lesions of the skin and/or underlying soft tissues caused by prolonged and/or elevated exposure to compressive and shearing forces. Pressure ulcers 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.
Following the successful conduct of a scoping review, an international multi-stakeholder Delphi study and a consensus conference, the following core outcome domains were identified (Lechner al. 2022):
1. Pressure ulcer occurrence: Pressure ulcers that develop anywhere on the body (reporting pressure ulcers specifically for defined body sites or device‐related pressure ulcers will be decided at a later stage)
2. Pressure ulcer precursor signs and symptoms: Early pressure ulcer warning signs and symptoms including pain (not restricted to the skin)
3. Mobility: Patient’s ability to move (e.g. turn over in bed and/or walk)
4. Acceptability and comfort of intervention : How well the patient accepts the prevention technique and the patient’s comfort or discomfort
5. Adherence/compliance: Adherence and compliance of patients. Do patients use prevention techniques in the way they are intended to?
6. Adverse events/safety: Harmful or negative events that occur during the trial, for example injuries, falls, skin irritation or allergic reactions
Project Goal
To develop a core outcome sets for pressure ulcer prevention trials.
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. https://pubmed.ncbi.nlm.nih.gov/31331366/
Lechner A, Kottner J, Coleman S, Muir D, Beeckman D, Chaboyer W, Cuddigan J, Moore Z, Rutherford C, Schmitt J, Nixon J, Balzer K. Outcomes for Pressure Ulcer Trials (OUTPUTs) project: review and classification of outcomes reported in pressure ulcer prevention research. Br J Dermatol. 2021;184(4):617-626. https://pubmed.ncbi.nlm.nih.gov/32510579/
Lechner A, Coleman S, Balzer K, Kirkham JJ, Muir D, Nixon J, Kottner. Core outcomes for pressure ulcer prevention trials: results of an international consensus study: Classification: Outcomes and qualitative research. J. Br J Dermatol. 2022 Nov;187(5):743-752. https://pubmed.ncbi.nlm.nih.gov/35789479/
