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Identifying core instruments for inclusion in the core outcome set for lichen sclerosus trials (CORALS)

   Centre for Evidence Based Dermatology, Lifespan & Population Health, School of Medicine

   Applications accepted all year round  Funded PhD Project (European/UK Students Only)

About the Project

Applications are invited for a PhD studentship (three-years full-time) within the Centre of Evidence Based Dermatology at the University of Nottingham. 

The Centre of Evidence Based Dermatology (CEBD)

The CEBD has an international reputation for independent research into the prevention and treatment of skin disease. It is the editorial base for Cochrane Skin and the co-ordinating centre for the UK Dermatology Clinical Trials Network.  The Centre includes a multi-disciplinary team of approximately 20 researchers and PhD students with expertise in systematic reviewing, the design and conduct of clinical trials, disease definition, consensus methodology, patient involvement and outcomes research. There are several ‘hubs’ covering different areas of dermatological practice. The ‘Vulval and genital disease’ hub is a departmental strategic priority area to which this PhD will contribute. The CEBD attracts around £1 million of external, independent grant income per year with a focus on delivering independent clinical research that informs the NHS. For further information visit: http://www.nottingham.ac.uk/dermatology. ;

The project

Lichen sclerosus (LS) is a chronic inflammatory condition which predominantly affects genital skin. It causes distressing symptoms as well as having a significant impact on quality of life. Inflammation can cause scarring with irreversible anatomical changes and approximately 5% of cases progress to develop cancer. Several types of treatment are available for LS and they are generally aimed at symptom relief, reducing progression of scarring, minimising cancer risk and maintaining normal daily function. One of the main limiting factors in pooling data from multiple RCTs and conducting meta-analyses is the variation in outcome measures selected to capture treatment effects, and differences in how and when these outcomes are measured. CORALS (Core Outcomes for Research in Lichen Sclerosus) is a global collaborative network to agree a core outcome set for LS. The collaboration includes patients, clinicians, pharmaceutical industry representatives and regulators. For more information about CORALS please see: CORALS - The University of Nottingham.

A core outcome set is an essential set of outcomes that are recommended for collection in all future trials for a given condition (http://www.comet-initiative.org/about/overview). By defining a core outcome set, results from different trials can be compared more easily and the quality of trials can be improved. Better quality trials will mean better outcomes for patients.

CORALS has identified, by international consensus, three core outcome domains (‘what’ to measure in LS clinical trials). These core domains are symptoms, clinical signs and quality of life. The next stage is to identify outcome instruments which will be used to measure the domains (‘how’ to measure). The proposed series of linked studies, which make up this PhD, will finalise the core instrument for a chosen domain.

Project objectives

This project will follow established methodology for core outcome set development: 

  1. Identification of all possible outcome instruments via systematic literature review.
  2. Quality assessment of the identified instruments’ psychometric properties using the COSMIN critical appraisal tool checklist.
  3. Qualitative study to establish the identified instruments’ validity and feasibility via patient discussion groups. Narrow the long list of potential instruments down to short list.
  4. Address validation gaps in the short list of potential instruments via multicentre longitudinal observational clinical study.
  5. If no suitable instruments are identified, the student will consider the development of a novel outcome scale for LS.

This project would give the successful applicant the opportunity to learn skills in:

  1. Conducting systematic reviews
  2. Development of outcome scales for use in clinical research
  3. Testing psychometric properties of scales
  4. Designing and conducting studies to evaluate psychometric properties (including qualitative and quantitative studies)
  5. Statistical techniques
  6. Consensus methodology
  7. Patient and public involvement

The student will have an opportunity to work alongside international members of the CORALS initiative and present findings at both national and international conferences. It is expected that the student will write at least four papers for peer-reviewed journals. 

The CORALS initiative has multistakeholder international membership, and this network will ensure rapid global dissemination of your findings.

Further Information

Applicants must have at a minimum of a UK (or equivalent) 2.1 degree in a relevant discipline. It is desirable that they have a MSc in Medical Statistics, Psychology, Epidemiology, Public Health or a related area with very good results, excellent quantitative skills, practical experience of analysing data with a meticulous approach and an interest in eczema. Prior experience of development or evaluation of outcome instruments will be advantageous. Informal enquiries may be addressed to Dr Rosalind Simpson ().

The University of Nottingham is the top 1% of global universities and is ranked eight in the UK on a measure of ‘research power’, with more than 80% of research rated as world-leading or internationally excellent. The University of Nottingham also offers a world-class research training environment for postgraduate students, including an excellent range of support and services.

To apply, students should send a CV, cover letter explaining why they would like the opportunity to study for this PhD, when they are available to start their studies, and details of two referees to Dr Rosalind Simpson (). 

Please quote ref: Closing date: Advertised until filled.

Funding Notes

The studentship will include the payment of tuition fees at the Home/EU rate and a maintenance stipend at current RCUK levels (£16,062 for 2022/23, updated each year). Non-EU students are welcome, but they would have to self-fund the difference between the Home/EU (£4,596) and international fee (£20,000).

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