Planning step by step

Planning phase means clear goals, details on screening policy, feasibility testing and clinical validation, setting up coordination, training staff, preparing the information technology. Plans for reducing barriers and social inequalities are needed. These aspects prepare for piloting the programme.

In the coordination phase this is your check-list:

• Screening management and quality assurance teams ready
• Evaluation planning
• Policy objectives and targets
• Clinical validation of methods, feasibility testing
• Finalizing screening policy, protocols, and indicators
• Information technology and systems
• Contracting and training staff and centres for the pilot programme

Legal frameworks

Legal framework is designed to run the health services and to regulate the comprehensive information systems.  These ensure the organization and quality of population-based screening programmes.

The legal framework should provide regulation on

• patient rights
• consent requirements
• personal data safety
• institutional responsibilities
• financing and tendering
• electronic health records
• tissue sampling and biobanking
• population and cancer registration
• scientific research and development
• adequate balance between fundamental rights of
• privacy
• access to effective, safe, high-quality and cost-efficient health services

Confidentiality of personally identifiable information on health status must be protected while fulfilling the duty to demonstrate and optimize health benefits and minimize negative effects and costs of screening.

The legal code in a country should provide a specific framework for population-based cancer screening, enabling as a minimum the following basic functions: personal invitation, mandatory notification and central registration of complete screening and outcome data, individual linkage to cancer and cause of death registries for appropriate quality assurance, including audits.

Governance structure

Successful evidence-based cancer screening needs a competent, multidisciplinary, and transparent governance structure with political, financial and stakeholder support. The figure below presents an example of a national governance structure, which covers the key tasks.

The Ministry of Health is responsible for planning and implementation of health policy in general. It assumes the ultimate responsibility for the management of the national resources to the health benefit of their entire population by directing the establishment of as good and fair a health system as possible and by promoting health aspects in all policies.

A designated national screening board is responsible for providing advice to the ministry on policies and decision-making regarding modifications to existing programmes and new population-based screening programmes. The board should ensure that the necessary organizational, logistic, legal, and financial frameworks exist or can be developed. Defining institutional responsibilities, collaboration between the key institutes, and consultation with relevant stakeholders allows benefit from existing expertise and broad support and commitment.

A specific steering board for each cancer screening programme is responsible for the performance, quality assurance and evaluation of the screening programme, including the continuous assessment of the test methods and procedures, and the financial, ethical, and legal frameworks. It officially sets and maintains the overall goals of the screening programme. It also ensures that the means and mechanisms are in place to monitor and achieve those goals. It is the forum for resolving political, legal, organizational, technical, cost and management issues that have not been resolved elsewhere. To fulfil its tasks, the steering board must have access to both political and high-level administrative decision-makers, and it must be representative of the key stakeholders, including programme management.

Programme-specific management teams are responsible for running the programme on a day-to-day basis at the national or regional level, with a clear mandate from the steering board and the necessary resources to fulfil its responsibilities. These responsibilities include coordination or supervision of all steps in the screening process from identification of the target population to surveillance after treatment of screen-detected cases. It further includes the development and dissemination of information material, collection, and validation of monitoring data, and using that data for continuous quality improvement.

Periodic formal programme evaluation may be tasked to an independent unit to avoid self-assessment by the management team. Some responsibilities may feasibly be delegated to the regional and local levels along with the adequate mandates and resources. In federated and larger countries, regions may have their own management teams, but policy should be formulated at the national level. Programme evaluation should also have a national scope.

A multidisciplinary advisory board ensures good communication with all screening service providers by providing representation for the professional groups and institutions that screening delivery depends upon. This facilitates the flow of information of issues of current import between management and the screening service providers and advocacy groups and sharing information with academic and professional societies and institutions.

Screening coordination

Following the political decision with associated budget allocations to start implementing a population-based cancer screening programme within the appropriate governance structure, the first step is to establish coordination and allocate institutional responsibilities.

The institution housing the management unit should receive a clear mandate and resources to manage the entire process of programme implementation. The management unit also has to prepare the budget details through all phases, including the resources required for quality assurance, programme management and staff training.

Establishing coordination necessitates close collaboration with authorities and all stakeholders, preferably within a well-defined and mandated governance structure. The mandate may also require changes in national legislation to ensure that it does not contradict effective implementation. Considerable autonomy to take organizational decisions must be allowed for coordination.

It is essential that a screening programme is managed by specialists with adequate knowledge and training in the subject areas of cancer screening. Specific training possibilities in the EU are available. Experience from other EU countries could be helpful; experts from other countries should be involved as consultants if local expertise is unsatisfactory.

Professional expertise should be utilized from the planning phase (development of standards and quality indicators) and throughout the implementation and for continuous evaluation. The professional and organizational management structure must be equipped with the competence and the mandate to control the quality of the entire screening process.

Registration and linkages

For effective management you will need:

• a legal mandate to register centrally all screening, diagnostic and treatment activity
• a personal identifier, including negative test results, and to cover both programme-initiated and opportunistic testing
• the registration that is sufficiently detailed, of high quality and complete (means active consent requirements for registration)

It is crucial to  have linkage to:

• population registry (target group identification)
• screening registries (performance information)
• cancer and cause of death registries (outcome information)

Identifying target groups and getting performance and outcome information requires the building of population-based cancer registries where such registries do not yet exist. However, cancer screening can be started even if cancer registry is not yet available.