Abstract
Background
There is substantial heterogeneity between trial outcomes in pressure ulcer prevention research. The development of core outcome sets (COS) is one strategy to improve comparability between trial results and thus increase the quality of evidence.
Objectives
The aim of this study was to identify core outcomes for pressure ulcer prevention trials.
Methods
A workshop was held with service users to discuss their views and understanding of the outcomes identified by a scoping review and to identify any missing outcomes. In a next step a Delphi survey comprising three rounds was conducted to evaluate a compiled list of outcomes by their importance. Afterwards the preselection from the Delphi survey was discussed in a virtual consensus meeting with the aim of agreeing on a final set of core outcomes. Individuals who had completed all three rounds of the Delphi survey were eligible to participate in this meeting. Participants included practitioners, service users, researchers and industry representatives.
Results
The workshop did not reveal any missing outcomes, but the need for further efforts to make lay people understand what an outcome is in a study setting. The Delphi survey took place between December 2020 and June 2021. After the three rounds, 18 out of 37 presented outcomes were rated to be critically important. In the following consensus meeting six outcomes were prioritized to be included in the COS for pressure ulcer prevention trials: (1) pressure ulcer occurrence, (2) pressure ulcer precursor signs and symptoms, (3) mobility, (4) acceptability and comfort of intervention, (5) adherence/compliance and (6) adverse events/safety.
Conclusion
Based on a comprehensive list of outcomes in pressure ulcer prevention research, there was clear agreement on the six identified core outcomes in three international Delphi rounds and in the consensus meeting. Although outcome measurement instruments need to be identified next, the six identified core outcomes should already be considered in future trials, as service users, practitioners, researchers and industry representatives have agreed that they are critically important.
Study registration
The OUTPUTs project is registered in the COMET database (1) and is part of the Cochrane Skin-Core Outcome Set Initiative (2).
There is substantial heterogeneity between trial outcomes in pressure ulcer prevention research. The development of core outcome sets (COS) is one strategy to improve comparability between trial results and thus increase the quality of evidence.
Objectives
The aim of this study was to identify core outcomes for pressure ulcer prevention trials.
Methods
A workshop was held with service users to discuss their views and understanding of the outcomes identified by a scoping review and to identify any missing outcomes. In a next step a Delphi survey comprising three rounds was conducted to evaluate a compiled list of outcomes by their importance. Afterwards the preselection from the Delphi survey was discussed in a virtual consensus meeting with the aim of agreeing on a final set of core outcomes. Individuals who had completed all three rounds of the Delphi survey were eligible to participate in this meeting. Participants included practitioners, service users, researchers and industry representatives.
Results
The workshop did not reveal any missing outcomes, but the need for further efforts to make lay people understand what an outcome is in a study setting. The Delphi survey took place between December 2020 and June 2021. After the three rounds, 18 out of 37 presented outcomes were rated to be critically important. In the following consensus meeting six outcomes were prioritized to be included in the COS for pressure ulcer prevention trials: (1) pressure ulcer occurrence, (2) pressure ulcer precursor signs and symptoms, (3) mobility, (4) acceptability and comfort of intervention, (5) adherence/compliance and (6) adverse events/safety.
Conclusion
Based on a comprehensive list of outcomes in pressure ulcer prevention research, there was clear agreement on the six identified core outcomes in three international Delphi rounds and in the consensus meeting. Although outcome measurement instruments need to be identified next, the six identified core outcomes should already be considered in future trials, as service users, practitioners, researchers and industry representatives have agreed that they are critically important.
Study registration
The OUTPUTs project is registered in the COMET database (1) and is part of the Cochrane Skin-Core Outcome Set Initiative (2).
| Original language | English |
|---|---|
| Pages (from-to) | 743–752 |
| Number of pages | 10 |
| Journal | British Journal of Dermatology |
| Volume | 187 |
| DOIs | |
| Publication status | Published - 3 Nov 2022 |
Keywords
- Outcome
- Core Outcome Set
- Core Domain Set
- Delphi Survey
- Consensus Meeting
- OUTPUTS Project