Evidence Synthesis as a tool for the Evaluation of Therapeutic Medical Devices

Publicly funded healthcare systems are under increasing financial and political pressure to allocate their limited healthcare resources in a way that the health benefit for the society is maximised. To this end several countries / jurisdictions have set up formal healthcare evaluation processes aiming to establish if healthcare treatments represent good value for money. In the UK, the National Institute for Health and Clinical Excellence (NICE) has responsibility for recommending the adoption of healthcare treatments, based on evidence regarding their clinical and cost effectiveness.
The introduction of medical devices into the European Union does not require the same level of scrutiny as that for pharmaceuticals. Recently innovative methods of bringing together clinical evidence on effectiveness of treatments and economic data on the resources used have been developed and are beginning to be used by NICE. In this project I will systematically examine the potential use of these methods to appraise medical devices. The results of this reseach project will inform the decisions of national healthcare regulatory agencies.

The research objectives are to: (i) investigate the methods for generating cost effectiveness evidence for therapeutic medical devices. (ii) test out evidence synthesis methods to investigate the relative cost-effectiveness of medical devices using chronic venous leg ulceration as a tracer condition. (iii) explore alternative methods of evidence synthesis to integrate summary data with patient level economic and clinical data. The research methods include systematic review of the literature, comparative analysis, qualitative research with healthcare policy makers involving semi-structured interviews, and Bayesian evidence synthesis methods (among them mixed treatment comparisons; generalised evidence synthesis; multi-parameter evidence synthesis; comprehensive decision analytic modelling) using summary and patient level data. The delivery of this project will provide a formal framework for the evaluation of medical devices for the treatment of specific health conditions which can be used to inform healthcare decision making regarding adoption decisions.