Outcomes for Pressure Ulcer Trials (OUTPUTs): development of outcome measurement instruments for core domain outcomes

Pressure Ulcers (PUs) are “localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear” and are categorized numerically according to the tissue layers involved [1]. Skin sites susceptible to PUs are those exposed to pressure (e.g. buttocks and heels) in patients with very limited mobility where offloading is difficult. They remain a considerable patient safety issue worldwide [2], cause undue burden on patients quality of life [3] and have a significant financial impact to healthcare organizations [4]. International guidance [1] advocates PU prevention and the use of care interventions to facilitate this. This is informed by clinical trials of effectiveness, but the evidence is hampered by considerable heterogeneity of reported outcomes in the field, making interpretation difficult and identifying the need for an agreed Core Outcome Set (COS) for PU prevention studies.

COS are being developed in many clinical areas to increase the quality and comparability of clinical trial results as well as to ensure their relevance for patients. A COS represents an agreed standardized set of outcomes that describes the minimum that should be consistently reported in all clinical trials of a defined area [5]. It comprises a core domain set (defining what core outcomes should be measured) and a core measurement set (defining outcome measurement instruments (OMIs) for each core domain). Work to develop a COS for PU prevention trials is being led by an established international group of researchers and has been registered in the Core Outcome Measures in Effectiveness Trials (COMET) database as the ‘Outcomes for Pressure Ulcer Trials’ (OUTPUT - https://www.comet-initiative.org/studies/details/283).

The first part of this work agreed the core PU outcome domains to be included in the COS and incorporated four steps: (1) definition of the scope, (2) conducting a scoping review, (3) organizing facilitated workshops with service users, (4) performing international Delphi surveys and establishing consensus in an international face-to-face meeting with different stakeholders [6]. The agreed outcome domains for inclusion in the COS comprise PU occurrence, mobility, safety/adverse events, PU precursor signs and symptoms, acceptability and comfort of intervention, adherence/compliance.

The next stage and focus of this studentship is to reach consensus on preferred OMIs for the 6 agreed core outcome domains. It is acknowledged that the quality of methods used to select the core outcome measurement instruments varies considerably, with guidance aiming to improve/standardise the approach taken [5, 7].

The work of this studentship will build on this guidance and comprise three stages: (1) systematic reviews to identify existing OMIs and definitions, guided workshops with service users and a consensus-building process based on the Nominal group technique; (2) assessment of the measurement properties of the identified OMIs and (3) international consensus study to finalise the recommended OMIs and definitions [5, 7]. In addition, there is scope for the student to inform COS methodological development in one of the following areas of their choosing: consensus methods (e.g. comparison of different methods); participatory approaches; quality assessment of measurement instrument (e.g. defining “good” vs. “poor” properties for dichotomous outcomes).

Supervision comprises of the OUTPUTs core team, an established international group of lead PU researchers with extensive experience in clinical trials, COS development within the Cochrane Skin - Core Outcome Set Initiative (CS-COUSIN http://cs-cousin.org/cos-project-groups/) consensus methods and participatory approaches. This includes Dr Susanne Coleman and Prof Jane Nixon, Leeds Clinical Trials Research Unit, University of Leeds; Prof Jan Kottner, Charité Universitätsmedizin Berlin, Germany; Prof Katrin Balzer, University of Lübeck, Germany.

PPI has been an integral component of PU research led by the Leeds CTRU group who established the Pressure Ulcer Service User Network (PURSUN) over 10 years ago and developed innovative PPI methods/approaches [8]. Both PURSUN members and other PPI representatives have been central to the consensus process and including partnership working to develop COS language for prevention trials to underpin participant information for both clinicians and service users. In terms of the specific consensus methodology the student will be supported in the design and delivery of guided workshops with service users to inform agreement of the OMIs for each COS domain. 

HOW TO APPLY

You are applying for a PhD studentship from the MRC TMRP DTP. A list of potential projects and the application form is available online at:

http://www.methodologyhubs.mrc.ac.uk/about/tmrp-doctoral-training-partnership/

Please complete the form fully. Incomplete forms will not be considered. CVs will not be accepted for this scheme.

Please apply giving details for your first choice project. You can provide details of up to two other TMRP DTP projects you may be interested in at section B of the application form.

Before making an application, applicants should contact the project supervisor to find out more about the project and to discuss their interests in the research before 09 January 2023.

The deadline for applications is 4pm (GMT) 16 January 2023. Late applications will not be considered.

Completed application forms must be returned to: [Email Address Removed]

Informal enquiries may be made to Dr Susanne Coleman - [Email Address Removed]