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Development of an economic evaluation of diagnostic strategies: the case of monogenic diabetes.

ABSTRACT: To describe the development process for defining an appropriate model structure for the economic evaluation of test-treatment strategies for patients with monogenic diabetes (caused by mutations in the GCK, HNF1A or HNF4A genes).Experts were consulted to identify and define realistic test-treatment strategies and care pathways. A systematic assessment of published diabetes models was undertaken to inform the model structure.National Health Service in England and Wales.Experts in monogenic diabetes whose collective expertise spans the length of the patient care pathway.A defined model structure, including the test-treatment strategies, and the selection of a published diabetes model appropriate for the economic evaluation of strategies to identify patients with monogenic diabetes.Five monogenic diabetes test-treatment strategies were defined: no testing of any kind, referral for genetic testing based on clinical features as noted by clinicians, referral for genetic testing based on the results of a clinical prediction model, referral for genetic testing based on the results of biochemical and immunological tests, referral for genetic testing for all patients with a diagnosis of diabetes under the age of 30 years. The systematic assessment of diabetes models identified the IMS CORE Diabetes Model (IMS CDM) as a good candidate for modelling the long-term outcomes and costs of the test-treatment strategies for monogenic diabetes. The short-term test-treatment events will be modelled using a decision tree which will feed into the IMS CDM.Defining a model structure for any economic evaluation requires decisions to be made. Expert consultation and the explicit use of critical appraisal can inform these decisions. Although arbitrary choices have still been made, decision modelling allows investigation into such choices and the impact of assumptions that have to be made due to a lack of data.

SUBMITTER: Peters JL

PROVIDER: S-EPMC3657677 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Development of an economic evaluation of diagnostic strategies: the case of monogenic diabetes.

Peters Jaime L JL Anderson Rob R Hyde Chris C

BMJ open 20130528 5

<h4>Objectives</h4>To describe the development process for defining an appropriate model structure for the economic evaluation of test-treatment strategies for patients with monogenic diabetes (caused by mutations in the GCK, HNF1A or HNF4A genes).<h4>Design</h4>Experts were consulted to identify and define realistic test-treatment strategies and care pathways. A systematic assessment of published diabetes models was undertaken to inform the model structure.<h4>Setting</h4>National Health Servic ...[more]

PMID: 23793674

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Project description:OBJECTIVES:To evaluate and compare the lifetime costs associated with strategies to identify individuals with monogenic diabetes and change their treatment to more appropriate therapy. DESIGN:A decision analytical model from the perspective of the National Health Service (NHS) in England and Wales was developed and analysed. The model was informed by the literature, routinely collected data and a clinical study conducted in parallel with the modelling. SETTING:Secondary care in the UK. PARTICIPANTS:Simulations based on characteristics of patients diagnosed with diabetes <30 years old. INTERVENTIONS:Four test-treatment strategies to identify individuals with monogenic diabetes in a prevalent cohort of diabetics diagnosed under the age of 30 years were modelled: clinician-based genetic test referral, targeted genetic testing based on clinical prediction models, targeted genetic testing based on biomarkers, and blanket genetic testing. The results of the test-treatment strategies were compared with a strategy of no genetic testing. PRIMARY AND SECONDARY OUTCOME MEASURES:Discounted lifetime costs, proportion of cases of monogenic diabetes identified. RESULTS:Based on current evidence, strategies using clinical characteristics or biomarkers were estimated to save approximately £100-£200 per person with diabetes over a lifetime compared with no testing. Sensitivity analyses indicated that the prevalence of monogenic diabetes, the uptake of testing, and the frequency of home blood glucose monitoring had the largest impact on the results (ranging from savings of £400-£50 per person), but did not change the overall findings. The model is limited by many model inputs being based on very few individuals, and some long-term data informed by clinical opinion. CONCLUSIONS:Costs to the NHS could be saved with targeted genetic testing based on clinical characteristics or biomarkers. More research should focus on the economic case for the use of such strategies closer to the time of diabetes diagnosis. TRIAL REGISTRATION NUMBER:NCT01238380.

Project description:A standard of prehospital care for patients presenting with ST-segment elevation myocardial infarction (STEMI) includes prehospital 12-lead and advance Emergency Department notification or prehospital bypass to percutaneous coronary intervention centres. Implementation of either care strategies is variable across communities and neither may exist in some communities. The main objective is to compare prehospital care strategies for time to treatment and survival outcomes as well as cost effectiveness.PREDICT is a multicentre, prospective population-based cohort study of all chest pain patients 18 years or older presenting within 30 mins to 6 hours of symptom onset and treated with nitroglycerin, transported by paramedics in a number of different urban and rural regions in Ontario. The primary objective of this study is to compare the proportion of study subjects who receive reperfusion within the target door-to-reperfusion times in subjects obtained after four prehospital strategies: 12-lead ECG and advance emergency department (ED) notification or 3-lead ECG monitoring and alert to dispatch prior to hospital arrival; either with or without the opportunity to bypass to a PCI centre.We anticipate four challenges to successful study implementation and have developed strategies for each: 1) diversity in the interpretation of the ethical and privacy issues across 47 research ethics boards/committees covering 71 hospitals, 2) remote oversight of data guardian abstraction, 3) timeliness of implementation, and 4) potential interference in the study by concurrent technological advances. Research ethics approvals from academic centres were obtained initially and submitted to non academic centre applications. Data guardians were trained by a single investigator and data entry is informed by a detailed data dictionary including variable definitions and abstraction instructions and subjected to error and logic checks. Quality oversight provided by a single investigator. The window of the trial in each community has been confirmed with the base-hospital medical director to correspond to the planned technological advances of the system of care. We hope this comparative analysis across treatment strategies for clinical outcomes and cost will provide sufficient evidence to implement the superior strategy across all communities and improve outcomes for all STEMI patients.

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Development of an economic evaluation of diagnostic strategies: the case of monogenic diabetes.

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Development of an economic evaluation of diagnostic strategies: the case of monogenic diabetes.

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