Workshop: Diagnostic challenges and value based medicine
In deciding on the optimal strategy for diagnostic imaging one has to go
through several phases of research. The paradigm of drug development (typically undergoing phase I through III studies and a IVth hurdle)prior to market access seems a good way to introduce ‘value based medicine’.
In phase I a new product is identified and assessed for it’s potential for cure. Molecular structure and pharmacokinetics are in a sense is comparable to designing a new imaging modality such as MRI.Phase 2 comprises the first try out in healthy volunteers and patients to assess safety and effects. This is comparable to assessing test characteristics and predictive values.Next clinical value in the intended population will have to be determined in a phase III randomised clinical trial. New drugs should be efficacious and safe compared to relevant alternatives.
Diagnostics are often used in a hierarchical order, i.e., are part of a logical yet potentially variable sequence. Some have claimed that diagnostic RCTs should be performed. However, even with just three diagnostic tests tens of possible diagnostic strategies are theoretically feasible rendering a trial unfeasible. Provided the clinical course given a diagnosis is known decision modelling is the solution. Exceptionally a trial may be indicated.
Lately, health care cost-effectiveness has given raise to critical questions. Dutch Health care authorities require a full economic evaluation as 4th step from pharmaceutical industry showing that clinical value is attained at a reasonable cost prior to reimbursement decisions.For devices and diagnostics there currently is no equivalent. Clearly, however, value based medicine suggests that the balance between costs and effects should be considered
Brief description:The workshop will comprise a brief presentation on economic evaluation
in health care, followed by an exercise where the participants are
challenged to comprehend three papers on a certain diagnostic problem,
i.e., diagnosis of (symptomatic) stenosis of the carotid artery.
