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Workstream 1

This workstream brings together leading health economists, methodologists and statisticians from Leeds, Birmingham and Oxford and aims to develop methodology to evaluate the optimal use and benefits of biomarkers for patient and disease monitoring in three stages:
  1. Methodological review work to identify areas of research that could be developed or adapted for use in monitoring for disease progression or recurrence. This includes the examination of case studies for insight into current practice in monitoring for progression or recurrence, the review of existing randomised controlled trials (RCTs) of monitoring, and also the review of available methodology to identify areas of research that could be used or adapted for development and evaluation of monitoring strategies.
  2. How simulation models can be used to design and evaluate monitoring rules, particularly how information from an ongoing study can be used to adapt and optimise the design of that study. The reliability of a simulation model depends on the data upon which it is based. This stage will consider the way in which information obtained during an on-going study (the ELUCIDATE trial – workstream 3) can be analysed to optimise monitoring rules, and whether resulting adaptations for the design for the on-going study can be implemented without compromising its validity or clinical value.
  3. Health economics – optimising monitoring tests to meet a cost-effectiveness decision rule; characterising cost-effectiveness of diagnostic tests for resource allocation decisions; and assessing the value of further research.

Information and results arising from this important line of work is then used to feed back to the other workstreams, particularly workstream 3 – the ELUCIDATE trial, to provide guidance for future approaches.

Progress to Date
  • methodological reviews have found that RCTs are characterised by lack of power, issues with study validity and lack of compliance with prescribed monitoring strategies both by patients and by clinicians. Monitoring strategies are complex interventions and, as such, can influence patient outcome in a multitude of ways, both expected and unanticipated. Furthermore limited attention has been paid to basic features of measurement and measurement error. A new CONSORT extension may be required to improve standards
  • following examinations of case studies, such as PSA for monitoring of prostate cancer, it is clear that there is limited evidence of the use of systematic methodologies to develop monitoring strategies 
  • simulation studies are being used to identify optimal strategies in terms of test schedules and decision rules, and emphasise that net health benefit at the population level should be an important part of the justification of any particular case definition threshold. A formal decision analytic approach can be used to identify the threshold that optimizes the contribution of these technologies to population health in a given health care system.
Recent Publications:
  1. Longo R, Baxter P, Hall P, Hewison J, Afshar M, Hall G, McCabe C. Methods for identifying the cost effective case definition threshold for sequential monitoring tests: an extension of Phelps and Mushlin. PharmacoEconomics. 2014; 32:327-334.

  2. Dinnes J, Hewison J, Altman D, Deeks J. The basis for monitoring strategies in clinical guidelines: a case study of prostate specific antigen for monitoring in prostate cancer. Canadian Medical Association Journal. 2012; 184(2):169-77.
  3. Dinnes J, Hewison J, Altman D, Deeks J. What can available randomised controlled trials evaluating monitoring strategies tell us about the design and analysis of future trials? Paper presented at MRC Clinical Trials Methodology Conference, Bristol UK; Oct 4-5 2011.

This website presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0707-10101: Evaluating the benefits for patients and the NHS of new and existing biological fluid biomarkers in liver and renal disease)

The views and opinions expressed by the authors of this website are those of the authors and do not necessarily reflect those of the NHS, the NIHR or the Department of Health.

The Leeds Teaching Hospital NHS Trust 2014