Evaluating diagnostic strategies for early detection of cancer: the CanTest framework

Fiona M Walter, Matthew J Thompson, Ian Wellwood, Gary A Abel, William Hamilton, Margaret Johnson, Georgios Lyratzopoulos, Michael P Messenger, Richard D Neal, Greg Rubin, Hardeep Singh, Anne Spencer, Stephen Sutton, Peter Vedsted, Jon D Emery, Fiona M Walter, Matthew J Thompson, Ian Wellwood, Gary A Abel, William Hamilton, Margaret Johnson, Georgios Lyratzopoulos, Michael P Messenger, Richard D Neal, Greg Rubin, Hardeep Singh, Anne Spencer, Stephen Sutton, Peter Vedsted, Jon D Emery

Abstract

Background: Novel diagnostic triage and testing strategies to support early detection of cancer could improve clinical outcomes. Most apparently promising diagnostic tests ultimately fail because of inadequate performance in real-world, low prevalence populations such as primary care or general community populations. They should therefore be systematically evaluated before implementation to determine whether they lead to earlier detection, are cost-effective, and improve patient safety and quality of care, while minimising over-investigation and over-diagnosis.

Methods: We performed a systematic scoping review of frameworks for the evaluation of tests and diagnostic approaches.

Results: We identified 16 frameworks: none addressed the entire continuum from test development to impact on diagnosis and patient outcomes in the intended population, nor the way in which tests may be used for triage purposes as part of a wider diagnostic strategy. Informed by these findings, we developed a new framework, the 'CanTest Framework', which proposes five iterative research phases forming a clear translational pathway from new test development to health system implementation and evaluation.

Conclusion: This framework is suitable for testing in low prevalence populations, where tests are often applied for triage testing and incorporated into a wider diagnostic strategy. It has relevance for a wide range of stakeholders including patients, policymakers, purchasers, healthcare providers and industry.

Keywords: Cancer; Conceptual framework; Diagnosis; Diagnostic strategies; Early detection; Primary care.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow Diagram for systematic scoping review
Fig. 2
Fig. 2
a The CanTest Framework. b The CanTest Framework - Design and Methods

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