Abbreviations: CEA = cost-effectiveness analysis; CUA = cost-utility analysis * May be reduced to cost-minimisation analysis. Cost-minimisation analysis should only be presented when the proposed service has been indisputably demonstrated to be no worse than its main comparator(s) in terms of both effectiveness and safety, so the difference between the service and the appropriate comparator can be reduced to a comparison of costs. In most cases, there will be some uncertainty around such a conclusion (i.e., the conclusion is often not indisputable). Therefore, when an assessment concludes that an intervention was no worse than a comparator, an assessment of the uncertainty around this conclusion should be provided by presentation of cost-effectiveness and/or cost-utility analyses. ^ No economic evaluation needs to be presented; MSAC is unlikely to recommend government subsidy of this intervention Summary of PICO for Population 1 Table 5 Summary of extended PICO to define research question that assessment will investigate for population 1 Patients Intervention Comparator(s) Reference test(s) Outcomes to be assessed Exercise ECG in Coronary Patients Cardiac MRI of Effectiveness patients with an angiography presenting with myocardial stress Health outcomes interpretable symptoms perfusion, and Cardiac disease specific mortality rate resting ECG, consistent with viability using Survival rate who are able to ischaemic heart delayed gadolinium Adverse cardiac event over defined period complete a disease, with an enhancement Cardiac hospitalisation treadmill test; for intermediate Quality of life scores others: probability of CAD Diagnostic accuracy (for detecting Exercise or myocardial ischaemia) dobutamine stress echo Sensitivity, specificity (confirmed by reference standard) Exercise or Positive likelihood ratio, negative likelihood pharmacologic ratio (confirmed by reference standard) (adenosine or Positive predictive value, negative predictive dobutamine) value (confirmed by reference standard) SPECT ROC curves Unsatisfactory or uninterpretable test results CTCA Patient management Change in clinical diagnosis Change in treatment pathway (initiated, ceased, modified, avoided) Patient compliance/preference for with imaging Time to initial diagnosis Time from diagnosis to treatment Safety Gadolinium contrast adverse reaction Claustrophobia Physical harms from follow-up testing Other adverse events arising from CMRI Cost-effectiveness Cost Cost per quality adjusted life year or disability adjusted life year Incremental cost-effectiveness ratio
Abbreviations: CEA = cost-effectiveness analysis; CUA = cost-utility analysis * May be reduced to cost-minimisation analysis. Cost-minimisation analysis should only be presented when the proposed service has been indisputably demonstrated to be no worse than its main comparator(s) in terms of both effectiveness and safety, so the difference between the service and the appropriate comparator can be reduced to a comparison of costs. In most cases, there will be some uncertainty around such a conclusion (i.e., the conclusion is often not indisputable). Therefore, when an assessment concludes that an intervention was no worse than a comparator, an assessment of the uncertainty around this conclusion should be provided by presentation of cost-effectiveness and/or cost-utility analyses. ^ No economic evaluation needs to be presented; MSAC is unlikely to recommend government subsidy of this intervention Summary of PICO for Population 1 Table 5 Summary of extended PICO to define research question that assessment will investigate for population 1 Patients Intervention Comparator(s) Reference test(s) Outcomes to be assessed Patients presenting with symptoms consistent with ischaemic heart disease, with an intermediate probability of CAD Cardiac MRI of myocardial stress perfusion, and viability using delayed gadolinium enhancement Exercise ECG in patients with an interpretable resting ECG, who are able to complete a treadmill test; for others: Exercise or dobutamine stress echo Exercise or pharmacologic (adenosine or dobutamine) SPECT CTCA Coronary angiography Effectiveness Health outcomes Cardiac disease specific mortality rate Survival rate Adverse cardiac event over defined period Cardiac hospitalisation Quality of life scores Diagnostic accuracy (for detecting myocardial ischaemia) Sensitivity, specificity (confirmed by reference standard) Positive likelihood ratio, negative likelihood ratio (confirmed by reference standard) Positive predictive value, negative predictive value (confirmed by reference standard) ROC curves Unsatisfactory or uninterpretable test results Patient management Change in clinical diagnosis Change in treatment pathway (initiated, ceased, modified, avoided) Patient compliance/preference for with imaging Time to initial diagnosis Time from diagnosis to treatment Safety Gadolinium contrast adverse reaction Claustrophobia Physical harms from follow-up testing Other adverse events arising from CMRI Cost-effectiveness Cost Cost per quality adjusted life year or disability adjusted life year Incremental cost-effectiveness ratio
1237-CardiacMRI-RatifiedFinalProtocol.DOCX