PhD Study : The impact of the analytical performance of laboratory tests on clinical decision making

Summary

Research problem:

Medical laboratory test results are believed to inform 70% of clinical management decisions e.g. the formulation of a diagnosis, disease surveillance, identification of patients at risk of a disease, as well as, the decision to start, discontinue, or adjust a particular treatment. Furthermore, laboratory testing is a key element in 80% of all clinical practice guidelines. However, all laboratory test results are subject to analytical error arising from both analytical bias and imprecision which are intrinsic attributes of the analytical measurement system used.

Where laboratory test results are used for diagnosis, disease monitoring or risk stratification, analytical error may result in misdiagnosis or incorrect stratification of patient risk and inappropriate clinical management decisions. The impact of analytical error on clinical decision making and patient outcomes is not fully recognized by either clinicians, laboratory professionals or biomarker discovery scientists and the topic has received little attention in the biomedical literature. Defining the impact of the analytical performance of laboratory tests on clinical decision making will help inform the design of care pathways and the minimum analytical performance requirements for individual tests to allow optimum clinical utility.

Project rationale:

The analytical performance characteristics (expressed as bias and imprecision) are readily available for a large range of laboratory tests. For care pathways, which incorporate laboratory test cut offs for diagnostic or clinical management decisions, computer simulation modelling can be used to examine the clinical impact of variation in test imprecision and bias. Computer simulation offers many advantages. Firstly it is efficient and cost-effective. Secondly, such insights cannot be readily obtained in any other way since to perform clinical trials using tests of differing analytical performance characteristics would pose major ethical, logistical and trial design challenges and would be prohibitively expensive. Thirdly, unlike clinical trials, modelling poses no patient safety risks.

Project aim and objectives:

The aim of this project is to use simulation modelling based on anonymised patient data, derived from a medical laboratory database, to explore the relationship between analytical error for selected laboratory tests, clinical decision making, and potential patient impact. The project will consider whether simulation modelling of analytical error can be used to inform the minimum analytical test performance necessary to yield maximum clinical utility for individual medical laboratory tests.

The specific objectives of this study include:

1) For selected tests, develop a simulation approach to determine the effects of assay imprecision and bias on clinical decision making within relevant clinical care pathways and patient outcomes using real patient data extracted from a medical laboratory database.

2) For selected tests, use simulation modelling to define the minimum acceptable analytical performance requirements necessary to optimise clinical utility of the test.

3) Use modelling approaches to compare performance of clinical assays with performance criteria set by regulatory agencies.

Resources:

The PhD student will be supported by staff/RA’s/PhD students within CNET and Life and Health Science. Also available to the candidate are MATLAB/C++/Python/cluster computing and data access to laboratory datasets from the Altnagelvin Area Hospital

Essential criteria

Applicants should hold, or expect to obtain, a First or Upper Second Class Honours Degree in a subject relevant to the proposed area of study.

We may also consider applications from those who hold equivalent qualifications, for example, a Lower Second Class Honours Degree plus a Master’s Degree with Distinction.

In exceptional circumstances, the University may consider a portfolio of evidence from applicants who have appropriate professional experience which is equivalent to the learning outcomes of an Honours degree in lieu of academic qualifications.

• Research proposal of 1500 words detailing aims, objectives, milestones and methodology of the project
• A demonstrable interest in the research area associated with the studentship

Desirable Criteria

If the University receives a large number of applicants for the project, the following desirable criteria may be applied to shortlist applicants for interview.

• First Class Honours (1st) Degree
• Masters at 70%
• For VCRS Awards, Masters at 75%
• Publications - peer-reviewed
• Experience of presentation of research findings
• Applicants will be shortlisted if they have an average of 75% or greater in a first (honours) degree (or a GPA of 8.75/10). For applicants with a first degree average in the range of 70% to 74% (GPA 3.3): If they are undertaking an Masters, then the average of their first degree marks and their Masters marks will be used for shortlisting.

Funding and eligibility

The University offers the following levels of support:

Department for the Economy (DFE)

The scholarship will cover tuition fees at the Home rate and a maintenance allowance of £19,000 (tbc) per annum for three years (subject to satisfactory academic performance).

This scholarship also comes with £900 per annum for three years as a research training support grant (RTSG) allocation to help support the PhD researcher.

• Candidates with pre-settled or settled status under the EU Settlement Scheme, who also satisfy a three year residency requirement in the UK prior to the start of the course for which a Studentship is held MAY receive a Studentship covering fees and maintenance.
• Republic of Ireland (ROI) nationals who satisfy three years’ residency in the UK prior to the start of the course MAY receive a Studentship covering fees and maintenance (ROI nationals don’t need to have pre-settled or settled status under the EU Settlement Scheme to qualify).
• Other non-ROI EU applicants are ‘International’ are not eligible for this source of funding.
• Applicants who already hold a doctoral degree or who have been registered on a programme of research leading to the award of a doctoral degree on a full-time basis for more than one year (or part-time equivalent) are NOT eligible to apply for an award.

Due consideration should be given to financing your studies. Further information on cost of living