Core outcomes for pressure ulcer prevention trials: results of an international consensus study: Classification: Outcomes and qualitative research.

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. What is already known about this topic? There are numerous trials on pressure ulcer prevention, but evidence on the effectiveness of preventive measures is limited due to heterogeneity between trial outcomes. The development of a core outcome set is one strategy to improve comparability between trial results. What does this study add? A service user workshop, a three-round Delphi survey and an online consensus meeting with practitioners, service users, researchers and industry representatives were conducted to identify core outcomes for pressure ulcer prevention trials. Six core outcomes were defined: (i) pressure ulcer occurrence, (ii) pressure ulcer precursor signs and symptoms, (iii) mobility, (iv) acceptability and comfort of intervention, (v) adherence/compliance and (vi) adverse events/safety. What are the clinical implications of this work? Better evidence of interventions for pressure ulcer prevention will help health professionals and service users to decide which interventions are most appropriate and effective. Better evidence may contribute to better pressure ulcer prevention.