Outcomes for Pressure Ulcer Trials (OUTPUT)

Systematic reviews in the field of pressure ulcer prevention and treatment have identified that there is no distinction made between phase 2 and phase 3 trial design and inconsistent use of outcome measures.

We plan to undertake statistical modelling/consensus methods to agree core outcomes for early and late phase trials for prevention and treatment of pressure ulcers.

Protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3543-9


Jane Nixon, Professor of Tissue Viability and Clinical Trials Research
Clinical Trials Research Unit
University of Leeds

Others to be confirmed

Further Study Information

Current Stage: Ongoing
Funding source(s): Sources of funding currently being pursued through NIHR Fellowships/Professorships and Pressure Ulcer Societies (European/American/Asian))

Health Area

Disease Category: Wounds

Disease Name: Ulcers (pressure)

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Device

Stakeholders Involved

- Clinical experts
- Service users
- Trialists

Study Type

- COS for clinical trials or clinical research


Primary interventions are devices for prevention (eg mattresses, cushions), but scope will need to be defined.

Phase 2 endpoint definitions
Systematic review, statistical modelling and consensus methods

Phase 3 endpoint definitions
Systematic review and consensus methods

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