Use of Decision Modelling in Economic Evaluations of Diagnostic Tests: An Appraisal and Review of Health Technology Assessments in the UK

Diagnostic tests play an important role in the clinical decision-making process by providing information that enables patients to be identified and stratified to the most appropriate treatment and management strategies. Decision analytic modelling facilitates the synthesis of evidence from multiple sources to evaluate the cost effectiveness of diagnostic tests. This study critically reviews the methods used to model the cost effectiveness of diagnostic tests in UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) reports. UK NIHR HTA reports published between 2009 and 2018 were screened to identify those reporting an economic evaluation of a diagnostic test using decision analytic modelling. Existing decision modelling checklists were identified in the literature and a modified checklist tailored to diagnostic economic evaluations was developed, piloted and used to assess the diagnostic models in HTA reports. Of 728 HTA reports published during the study period, 55 met the inclusion criteria. The majority of models performed well with a clearly defined decision problem and analytical perspective (89% of HTAs met the criterion). The model structure usually reflected the care pathway and progression of the health condition. However, there are areas requiring improvement. These are predominantly systematic identification of treatment effects (20% met), poor selection of comparators (50% met) and assumed independence of tests used in sequence (32% took correlation between sequential tests into consideration). The complexity and constraints of performing decision analysis of diagnostic tests on costs and health outcomes makes it particularly challenging and, as a result, quality issues remain. This review provides a comprehensive assessment of modelling in HTA reports, highlights problems and gives recommendations for future diagnostic modelling practice.

[1]  Uwe Siebert,et al.  Modeling Good Research Practices—Overview , 2012, Medical decision making : an international journal of the Society for Medical Decision Making.

[2]  P. Royle,et al.  Multiplex tests to identify gastrointestinal bacteria, viruses and parasites in people with suspected infectious gastroenteritis: a systematic review and economic analysis. , 2017, Health technology assessment.

[3]  J. Madan,et al.  Accurate diagnosis of latent tuberculosis in children, people who are immunocompromised or at risk from immunosuppression and recent arrivals from countries with a high incidence of tuberculosis: systematic review and economic evaluation. , 2016, Health technology assessment.

[4]  Jonathan Karnon,et al.  Model Parameter Estimation and Uncertainty Analysis , 2012, Medical decision making : an international journal of the Society for Medical Decision Making.

[5]  P. Bossuyt,et al.  Assessing the value of diagnostic tests: a framework for designing and evaluating trials , 2012, BMJ : British Medical Journal.

[6]  M. Pletcher,et al.  Risk Prediction in Cardiovascular Medicine Evaluating the Clinical Utility of a Biomarker A Review of Methods for Estimating Health Impact , 2011 .

[7]  Murray Krahn,et al.  Conceptualizing a model: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--2. , 2012, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[8]  David Moher,et al.  Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement , 2013, International Journal of Technology Assessment in Health Care.

[9]  T. Hoffmann,et al.  Cost effectiveness of patient education for the prevention of falls in hospital: economic evaluation from a randomized controlled trial , 2013, BMC Medicine.

[10]  M. Cowie National Institute for Health and Care Excellence. , 2015, European heart journal.

[11]  Nicola J Cooper,et al.  How is evidence on test performance synthesized for economic decision models of diagnostic tests? A systematic appraisal of Health Technology Assessments in the UK since 1997. , 2010, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[12]  J. Peters,et al.  Evidence used in model-based economic evaluations for evaluating pharmacogenetic and pharmacogenomic tests: a systematic review protocol , 2015, BMJ Open.

[13]  A. Mushlin,et al.  Focusing Technology Assessment Using Medical Decision Theory , 1988, Medical decision making : an international journal of the Society for Medical Decision Making.

[14]  Mark J Sculpher,et al.  Establishing the Value of Diagnostic and Prognostic Tests in Health Technology Assessment , 2018, Medical decision making : an international journal of the Society for Medical Decision Making.

[15]  Dan Greenberg,et al.  Cost-utility analyses of diagnostic laboratory tests: a systematic review. , 2011, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[16]  Johan L. Severens,et al.  ECONOMIC EVALUATION OF DIAGNOSTIC TESTS , 1999, International Journal of Technology Assessment in Health Care.

[17]  A. Sutton,et al.  Sentinel lymph node status in vulval cancer: systematic reviews of test accuracy and decision-analytic model-based economic evaluation. , 2013, Health technology assessment.

[18]  John P A Ioannidis,et al.  Diagnostic tests often fail to lead to changes in patient outcomes. , 2014, Journal of clinical epidemiology.

[19]  Nicola J Cooper,et al.  Integration of Meta-analysis and Economic Decision Modeling for Evaluating Diagnostic Tests , 2008, Medical decision making : an international journal of the Society for Medical Decision Making.

[20]  P. Lorgelly,et al.  Modeling companion diagnostics in economic evaluations of targeted oncology therapies: systematic review and methodological checklist , 2015, Expert review of molecular diagnostics.

[21]  M J Buxton,et al.  Modelling in economic evaluation: an unavoidable fact of life. , 1997, Health economics.

[22]  Pelham Barton,et al.  A Systematic Review of Research Guidelines in Decision-Analytic Modeling. , 2015, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[23]  J. Caro,et al.  Model transparency and validation: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--7. , 2012, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[24]  J. Deeks,et al.  Test-treatment RCTs are sheep in wolves' clothing (Letter commenting on: J Clin Epidemiol. 2014;67:612-21). , 2016, Journal of clinical epidemiology.

[25]  Maarten J. IJzerman,et al.  Toward Alignment in the Reporting of Economic Evaluations of Diagnostic Tests and Biomarkers: The AGREEDT Checklist , 2018, Medical decision making : an international journal of the Society for Medical Decision Making.

[26]  S. Golder,et al.  Good Practice Guidelines for Decision-Analytic Modelling in Health Technology Assessment , 2012, PharmacoEconomics.

[27]  C Fraser,et al.  The diagnostic accuracy and cost-effectiveness of magnetic resonance spectroscopy and enhanced magnetic resonance imaging techniques in aiding the localisation of prostate abnormalities for biopsy: a systematic review and economic evaluation. , 2013, Health technology assessment.

[28]  D. Owens,et al.  State-transition modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--3. , 2012, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[29]  T. Fanshawe,et al.  Evidence synthesis to inform model-based cost-effectiveness evaluations of diagnostic tests: a methodological review of health technology assessments , 2017, BMC Medical Research Methodology.

[30]  Martin Downes,et al.  Health Economic Decision Tree Models of Diagnostics for Dummies: A Pictorial Primer , 2020, Diagnostics.

[31]  G. Mowatt,et al.  Systematic review of the clinical effectiveness and cost-effectiveness of rapid point-of-care tests for the detection of genital chlamydia infection in women and men. , 2010, Health technology assessment.

[32]  Philippe Beutels,et al.  Accounting for Methodological, Structural, and Parameter Uncertainty in Decision-Analytic Models , 2011, Medical decision making : an international journal of the Society for Medical Decision Making.

[33]  S. Palmer,et al.  The clinical effectiveness and cost-effectiveness of technologies used to visualise the seizure focus in people with refractory epilepsy being considered for surgery: a systematic review and decision-analytical model. , 2012, Health technology assessment.

[34]  P. Whiting,et al.  High-sensitivity troponin assays for the early rule-out or diagnosis of acute myocardial infarction in people with acute chest pain: a systematic review and cost-effectiveness analysis. , 2015, Health technology assessment.

[35]  Uwe Siebert,et al.  Modeling good research practices--overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--1. , 2012, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[36]  C. Patch,et al.  Diagnostic strategies using DNA testing for hereditary haemochromatosis in at-risk populations: a systematic review and economic evaluation. , 2009, Health technology assessment.

[37]  Keith Abrams,et al.  Use of evidence in decision models: an appraisal of health technology assessments in the UK since 1997 , 2005, Journal of health services research & policy.

[38]  A. Verbeek,et al.  Efficient diagnostic test sequence: applications of the probability-modifying plot. , 2001, Journal of clinical epidemiology.

[39]  Murray Krahn,et al.  Conceptualizing a Model , 2012, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.