Assessing The Comparative Effectiveness Of A Diagnostic Technology: CT Colonography

Abstract

Medical imaging is a prime example of an innovation that has brought important advances to medical care while triggering concerns about potential overuse and excessive costs. Many hopes are riding on comparative effectiveness research to help guide better decision making to improve quality and value. But the dynamic nature of medical imaging poses challenges for the traditional paradigms of evidentiary review and analysis at the heart of comparative effectiveness. This paper discusses these challenges and presents policy lessons for manufacturers, evidence reviewers, and decisionmakers, illustrated by an assessment of a prominent emerging imaging technique: computed tomography (CT) colonography.

The emergence of diagnostic imaging technologies in breast cancer: discovery, regulatory approval, reimbursement, and adoption in clinical guidelines

“…Imaging technologies are constantly changing so by the time clinical trials are completed, technologies are often obsolete and the results are no longer applicable to clinical care [ 120 ] . Also, although no long-term studies have shown improvements in breast cancer recurrence or survival rates as a result of receipt of advanced imaging, many clinicians and patients believe that the added information derived from imaging must lead to better care [ 121 ] , so withholding imaging from breast cancer patients could be viewed as unethical.…”

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.

“…24,90,91 However, the conduct of a RCT to evaluate tests identifying the seizure focus in work-up for epilepsy surgery may be considered impractical for a number of reasons: the inability to match populations of very heterogeneous neocortical epilepsies; small study populations; large variation in clinical practice; the integral link between practitioners' experience and skill and the interpretation of results; the rapid advancements in the technology and the duration of follow-up required (by the completion of the trial, the results may not be applicable to current clinical practice); ethical considerations; the new diagnostic strategy is far safer and/or less burdensome to the patient than the currently used diagnostic test; or cost. 22,24,35,92,93 In addition, RCTs evaluating long-term quality-of-life and survival measures will have to be large, as the differences in these measures across diagnostic strategies may be small. 24 Ethical issues are likely to be a key consideration in this area of research if planning a RCT.…”

“…24,35,92 Modelling can also be used to investigate evidentiary assumptions about test performance and clinician decision-making, and examine all benefits, harms and costs together to provide cost-effectiveness and cost-utility information to decision-makers. 24,92 The major limitation of decision modelling is insufficient reliable data relating to key components of the model. 35 The reliability of the data available can depend on the clinical context in which the test is conducted (sole diagnostic modality, triage, further work-up, confirmatory test).…”

Toward Evidence-based Decisions in Diagnostic Radiology

“…For one, diagnostic accuracy is typically assessed on a “one-time” basis in comparison with a gold standard, without any information on the appropriate screening interval for future testing (15). In addition, emerging evidence is usually populated by relatively small studies of highly selected patients conducted at academic centers by those most experienced in the use of the device.…”