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  Implementing factorial designs in randomised controlled trials optimising complex interventions in health and social care settings


   Faculty of Medicine and Health

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  Dr R Walwyn, Prof Suzanne Richards, Dr S Smith  No more applications being accepted  Funded PhD Project (UK Students Only)

About the Project

In this research project an “intervention” is defined as anything put in place to improve outcomes for patients, staff, services or systems of health or social care. Examples include secondary care treatments for chronic fatigue syndrome, psychotherapy for conduct disorder, counselling for depression, group rehabilitation following traumatic brain injury or for multiple sclerosis, care of adults with dementia in care homes, audit and feedback of blood transfusion practice, and dental care. Complex problems often require interventions made up of multiple parts or ‘components’. Complex interventions are characterised as having several potentially interacting components, which may require those delivering and/or receiving the intervention to develop new skills or behaviours. In turn, this may result in changes across a range of outcomes of importance.

There is widespread consensus in the clinical and research communities in the UK that the gold standard approach to evaluating the effectiveness of a complex intervention is to treat it as a single ‘black box’ or package of components. Researchers design and implement experiments, referred to as randomised controlled trials (RCTs), to investigate whether a new intervention package works better than a current standard intervention package in the specific setting in which the trial takes place. However, this approach provides limited understanding of how different components (or different combinations of components) of the complex intervention affect outcomes, and how the intervention can be tailored to achieve optimal results for patients.

Optimisation trials, within a research framework referred to as the Multiphase Optimisation Strategy (MOST), can provide data on the contributions of the components that make up a complex intervention. They are specifically designed to ensure complex interventions are effective, affordable, scalable and efficient. They have different statistical designs, depending on the nature of the complex intervention to be optimised. Many of these designs have been used in agriculture and industry but their adoption in health and social care has been limited.

Dr Walwyn has secured a prestigious fellowship from the National Institute of Health Research (NIHR) to develop, and evaluate the use of, two classes of experimental design; one for optimising cascading interventions (e.g. therapists are trained, and then patients are treated) and another for optimising (learning) system-level interventions (i.e. components are targeted at more than one level in a health or social care system, so at patients and at staff for example). This work has the potential to shift the paradigm regarding how we develop, optimise and evaluate complex interventions in the UK and internationally.

Implementing an optimisation trial in practice is challenging, made more so by the unusual trial designs. Trials are composed of multi-disciplinary teams working across different settings, which need to design and then implement scientifically sound research protocols to achieve the desired outcome of robustly estimating the clinical and cost-effectiveness of new interventions. The UK has significant expertise in the design and delivery of individually- and cluster-randomised parallel-group RCTs located in centres of excellence in NIHR, NHS and University supported clinical trials infrastructure. However, there is limited knowledge and expertise of factorial optimisation trial designs across these trial teams, which may prove a critical barrier to their implementation. The focus of this PhD scholarship is to identify the barriers and enablers to implementing multiple types of factorial optimisation trial in our existing UK trials infrastructure, and to identify strategies to promote their adoption.

This scholarship will be nested in the ‘implementation workstream’ of Dr Walwyn’s wider programme of work. Four stakeholder engagement workshops are planned with UK research infrastructure to explore barriers and enablers to implementing different types of factorial design to optimise complex interventions. This platform will provide the candidate with a starting point to develop their methodological skills and research questions. Whilst identifying the implementation issues for factorial optimisation trials will be central to this doctorate, there is scope for you to develop other interests. This might include:

1)   developing methods for qualitative “process evaluations” and

2)   patient and public understanding and involvement in research methods.

The candidate might also choose to develop a particular health research interest. It is not expected that you will already have knowledge of optimisation trial designs. However, it would be an advantage if you had some experience or understanding of trials research. It is expected that the candidate will develop expertise in a range of research skills including: systematic methodological reviews, consensus methods and mixed-method research skills. This will provide you with transferrable skills that are in widespread demand in applied health services research. 

Eligibility:

You should hold a first-degree equivalent to at least a UK upper second-class honours degree, or suitable postgraduate degree in a health-related subject, psychology, or social science. You will be enthusiastic, organised and motivated with experience in, or knowledge of health or social care services and research. Importantly, you will be committed to fully engaging with a wider multi-disciplinary team to conduct high-quality research that is of value to the NHS.

Applicants whose first language is not English must provide evidence that their English language is sufficient to meet the specific demands of their study. The Faculty of Medicine and Health minimum requirements in IELTS and TOEFL tests are:

• British Council IELTS - score of 6.5 overall, with no element less than 6.0 • TOEFL iBT - overall score of 92 with the listening and reading element no less than 21, writing element no less than 22 and the speaking element no less than 23.

How to apply:

To apply for this scholarship opportunity applicants should complete an online application form and attach the following documentation to support their application. 

  • a full academic CV
  • degree certificate and transcripts of marks
  • Evidence that you meet the Faculties' English language requirements (if applicable)

To help us identify that you are applying for this scholarship project please ensure you provide the following information on your application form;

  • Select PhD in Medicine as your programme of study
  • Give the full project title and name the supervisors listed in this advert
  • For source of funding please state you are applying for a NIHR scholarship
Economics (10) Mathematics (25) Medicine (26) Nursing & Health (27) Psychology (31)

Funding Notes

A full or part-time PhD scholarship is available in the Methodological Research, Education and Innovation (M-REI) Division of the Leeds Institute of Clinical Trials Research (LICTR). This opportunity is linked to a prestigious National Institute for Health Research (NIHR) Advanced Fellowship. If full time the scholarship will attract an annual tax-free stipend of £18,622 for up to 3 years (or 5 years part time with a pro-rata stipend), subject to satisfactory progress, and will cover academic fees at the UK rate. Due to limited funding we can only consider applicants who are eligible to pay fees at the UK rate.

References

1. Skivington K et al (2021) A new framework for developing and evaluating complex interventions: Update of Medical Research Council guidance. British Medical Journal, 374: n2061
2. Collins LM (2018) Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: The Multiphase Optimization Strategy (MOST). New York: Springer
3. Collins LM, Kugler KC (2018) Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: Advanced Topics. New York: Springer
4. Moore GF (2015) Process evaluation of complex interventions: Medical Research Council guidance. British Medical Journal, 350: h1258

Where will I study?

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