TABLE II.

Consolidated principles for screening (adapted from Dobrow et al²)

Domain	Consolidated screening principles
Disease/condition principles	Epidemiology of disease/condition
	• Adequately understood
	• Seen as important health problem (high/increasing incidence/prevalence, associated with significant morbidity/mortality)
	Natural history of disease/condition
	• Adequately understood
	• Well-defined
	• A detectable preclinical phase exists
	Target population for screening
	• Clearly defined (eg, age group)
	• Identifiable
	• Able to be reached
Test/intervention principles	Screening test performance characteristics
	• Appropriate for the purpose
	• All key components of the test are accurate (sensitivity, specificity, positive predictive value), reliable/reproducible
	• Acceptable to the target population
	• Possible to perform/administer safely, affordably, and efficiently
	Interpretation of screening test results
	• Clearly interpretable and determinate (with known distribution of test values and well-defined/agreed-upon cutoff points) to enable identification of screened individuals who require/do not require diagnostic testing and other postscreening care
	Postscreening test options
	• An agreed-upon course of action for screened individuals with positive screening test results (involving diagnostic testing, treatment/intervention, and follow-up) that will modify the natural history/clinical pathway for the disease/condition
	• Available, accessible, and acceptable to those affected
	• Results in improved outcomes (eg, improved quality of life, improved function, decreased mortality)
	• The testing burden on individuals is understood and acceptable
	• Minimal effects of false-positive and false-negative test results
Program/system principles	Screening program infrastructure
	• Adequate existing infrastructure (eg, financial, human health and information technology resources, facilities, equipment, test technology) or a clear plan to develop new infrastructure
	• Appropriate for the setting, to allow for timely access to all components of the testing program (recruitment, testing, information access, diagnosis, referral, treatment, follow-up, patient education and support, staff training, program management and evaluation)
	Screening program coordination and integration
	• All components of the screening program are coordinated and where possible integrated with the broader health care system (including formal system to inform, counsel, refer, and manage treatment of screened individuals)
	• Optimize continuity of care and ensure no screened individual is neglected
	Screening program acceptability and ethics
	• All components of the screening program are clinically, socially, and ethically acceptable to screened individuals, health professionals, and society
	• Effective methods for provision of informed choice to screened individuals, promoting autonomy and protecting their rights
	Screening program benefits and harms
	• Expected range and magnitude of benefits (eg, improved quality of life, improved function, and decreased mortality) and harms (eg, overdiagnosis and overtreatment) for screened individuals and society are clearly defined and acceptable
	• Supported by existing, high-quality scientific evidence (or addressed by ongoing studies), indicating the overall benefit or the program outweighs potential harms
	Economic evaluation of screening program
	• An economic evaluation (eg, cost-effectiveness, cost-benefit, and cost-utility analyses) is performed/planned from a health system or societal perspective
	• Assessment of full costs and effects of implementing, operating, and sustaining the screening program
	• Considering opportunity costs and effect of allocating resources to other nonscreening alternatives (eg, primary prevention, improved treatment, and other clinical services) for managing the disease or condition
	Screening program quality and performance management
	• The screening program has clear goals/objectives that explicitly link to program planning, monitoring, evaluating, and reporting activities
	• Dedicated information systems and funding
	• Ensure ongoing quality control and achievement of performance targets

Reference: Dobrow et al.²