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


   School of Medicine

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  Dr Susanne Coleman  No more applications being accepted  Competition Funded PhD Project (Students Worldwide)

About the Project

Background: 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 heterogeneity of reported outcomes, making interpretation difficult and highlights 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.

What the studentship will encompass: The focus of this studentship is to reach consensus on preferred OMIs for the agreed COS 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]. This is a particular challenge in the PU prevention field, where there is substantial cross-trial variation regarding PU classification and methods used to determine PU presence as well as patient reported outcomes. This variation complicates the synthesis of trial results and hinders the development of clear-cut evidence-based practice recommendations to support clinical decision-making.

The work of this studentship will 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]. There is also 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).

Detail of supervision, including the roles of any named co-supervisors: Would comprise the OUTPUTs core team, who 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.

Detail of any PPI: PPI has been an integral component of research led by the Leeds CTRU group who established the Pressure Ulcer Service User Network (PURSUN)and developed innovative PPI methods/approaches [8]. Both PURSUN members and other PPI representatives have been central to the consensus process, including partnership working to develop COS language for prevention trials to underpin participant information for both clinicians and service users. 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.

Candidates should hold a first degree or Masters in a health relevant discipline. Experience of clinical trials (and specifically outcome considerations) and facilitation/consensus methods is desirable. 

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 primary supervisor to find out more about the project and to discuss their interests in the research.

The deadline for applications is 4pm (GMT) 18 February 2022. Late applications will not be considered.

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

Informal enquiries may be made to [Email Address Removed]


Funding Notes

Studentships are funded by the Medical Research Council (MRC) for 3 years. Funding will cover tuition fees at the UK rate only, a Research Training and Support Grant (RTSG) and stipend (stipend to include London Weighting where appropriate). We aim to support the most outstanding applicants from outside the UK and are able to offer a limited number of bursaries that will enable full studentships to be awarded to international applicants. These full studentships will only be awarded to exceptional quality candidates, due to the competitive nature of this scheme.

References

1. EPUAP, NPIAP, and PPPIA, Prevention and treatment of pressure ulcer/injuries: clinical practice guideline. the international guideline. Emily Haesler (ed), 2019.
2. Pieper, B.E., Pressure Ulcers: Prevalence, Incidence, and Implications for the Future. 2012, NPUAP: Washinton DC.
3. Gorecki, C., et al., What influences the impact of pressure ulcers on health-related quality of life? A qualitative patient-focused exploration of contributory factors. Journal of Tissue Viability, 2012. 21(1): p. 3-12.
4. Dealey, C., J. Posnett, and A. Walker, The cost of pressure ulcers in the United Kingdom. Journal of Wound Care, 2012. 21(6): p. 261-6.
5. Williamson, P.R., et al., The COMET Handbook: version 1.0. Trials, 2017. 18(3): p. 280.
6. Lechner, A., et al., 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): p. 449.
7. Gorst, S.L., et al., Methods used in the selection of instruments for outcomes included in core outcome sets have improved since the publication of the COSMIN/COMET guideline. J Clin Epidemiol, 2020. 125: p. 64-75.
8. Nixon, J., et al., in Pressure UlceR Programme Of reSEarch (PURPOSE): using mixed methods (systematic reviews, prospective cohort, case study, consensus and psychometrics) to identify patient and organisational risk, develop a risk assessment tool and patient-reported outcome Quality of Life and Health Utility measures. 2015: Southampton (UK).

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