Final refined set of consolidated screening principles
| Domain | Consolidated screening principles (after systematic review and modified Delphi consensus process) |
|---|---|
| Disease/condition principles | 1. Epidemiology of the disease or condition The epidemiology of the disease or condition should be adequately understood, and the disease or condition should be an important health problem (e.g., high or increasing incidence or prevalence, or causes substantial morbidity or mortality). |
| 2. Natural history of disease or condition The natural history of the disease or condition should be adequately understood, the disease or condition is well-defined, and there should be a detectable preclinical phase. | |
| 3. Target population for screening The target population for screening should be clearly defined (e.g., with an appropriate target age range), identifiable and able to be reached. | |
| Test/intervention principles | 4. Screening test performance characteristics Screening test performance should be appropriate for the purpose, with all key components specific to the test (rather than the screening program) being accurate (e.g., in terms of sensitivity, specificity and positive predictive value) and reliable or reproducible. The test should be acceptable to the target population and it should be possible to perform or administer it safely, affordably and efficiently. |
| 5. Interpretation of screening test results Screening test results should be clearly interpretable and determinate (e.g., with known distribution of test values and well-defined and agreed cut-off points) to allow identification of the screening participants who should (and should not) be offered diagnostic testing and other postscreening care. | |
| 6. Postscreening test options There should be an agreed on course of action for screening participants with positive screening test results that involves diagnostic testing, treatment or intervention, and follow-up care that will modify the natural history and clinical pathway for the disease or condition; that is available, accessible and acceptable to those affected; and that results in improved outcomes (e.g., increased functioning or quality of life, decreased cause-specific mortality). The burden of testing on all participants should be understood and acceptable, and the effect of false-positive and false-negative tests should be minimal. | |
| Program/system principles | 7. Screening program infrastructure There should be adequate existing infrastructure (e.g., financial resources, health human resources, information technology, facilities, equipment and test technology), or a clear plan to develop adequate infrastructure, that is appropriate to the setting to allow for timely access to all components of the screening program.* |
| 8. Screening program coordination and integration All components of the screening program* should be coordinated and, where possible, integrated with the broader health care system (including a formal system to inform, counsel, refer and manage the treatment of screening participants) to optimize care continuity and ensure no screening participant is neglected. | |
| 9. Screening program acceptability and ethics All components of the screening program* should be clinically, socially and ethically acceptable to screening participants, health professionals and society, and there should be effective methods for providing screening participants with informed choice, promoting their autonomy and protecting their rights. | |
| 10. Screening program benefits and harms The expected range and magnitude of benefits (e.g., increased functioning or quality of life, decreased cause-specific mortality) and harms (e.g., overdiagnosis and overtreatment) for screening participants and society should be clearly defined and acceptable, and supported by existing high-quality scientific evidence (or addressed by ongoing studies) that indicates that the overall benefit of the screening program outweighs its potential harms. | |
| 11. Economic evaluation of screening program An economic evaluation (e.g., cost-effectiveness analysis, cost–benefit analysis and cost–utility analysis) of the screening program, using a health system or societal perspective, should be conducted (or a clear plan to conduct an economic evaluation) to assess the full costs and effects of implementing, operating and sustaining the screening program while clearly considering the opportunity costs and effect of allocating resources to other potential nonscreening alternatives (e.g., primary prevention, improved treatments and other clinical services) for managing the disease or condition. | |
| 12. Screening program quality and performance management The screening program should have clear goals or objectives that are explicitly linked to program planning, monitoring, evaluating and reporting activities, with dedicated information systems and funding, to ensure ongoing quality control and achievement of performance targets. |
↵* Components of a screening program include recruitment, testing, information access, diagnosis, referral, treatment, follow-up, patient education and support, staff training and program management and evaluation.