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
Affiliations
Fiona M. Walter
The Primary Care Unit, Department of Public Health & Primary Care, University of Cambridge
Matthew J. Thompson
Department of Family Medicine, University of Washington
Ian Wellwood
The Primary Care Unit, Department of Public Health & Primary Care, University of Cambridge
Gary A. Abel
University of Exeter, St Luke’s Campus
William Hamilton
University of Exeter, St Luke’s Campus
Margaret Johnson
The Primary Care Unit, Department of Public Health & Primary Care, University of Cambridge
Georgios Lyratzopoulos
Department of Behavioural Science and Health, Epidemiology of Cancer Healthcare and Outcomes (ECHO) Research Group, University College London
Michael P. Messenger
National Institute of Health Research (NIHR) Leeds In Vitro Diagnostic Cooperative (IVDC), Leeds Centre for Personalised Medicine and Health, University of Leeds
Richard D. Neal
Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds
Greg Rubin
Institute of Health and Society, University of Newcastle, Sir James Spence Institute, Royal Victoria Infirmary
Hardeep Singh
Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine
Anne Spencer
Health Economics Group, University of Exeter, St Luke’s Campus
Stephen Sutton
The Primary Care Unit, Department of Public Health & Primary Care, University of Cambridge
Peter Vedsted
Research Centre for Cancer Diagnosis – CaP, The Research Unit for General Practice and Research Clinic for Innovative Health Care Delivery, Department of Clinical Medicine, Aarhus University
Jon D. Emery
Centre for Cancer Research and Department of General Practice, University of Melbourne
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.
