Table 2 Criteria of evaluation of quality of operational aspects [4]
Quality indicators | Profile of High Quality Rare Disease Registries |
|---|---|
Ethical and Legal issues | -Protocols are approved by ethics committee. -Transparency of activities, oversight, data ownership and data delivery, and conflict of interest -Patient confidentiality, informed consent. |
Access to data and security | -Data are made available anonymously to public institutions, public authorities, patient associations and private institutions/citizens, centres of expertise within the country and worldwide -Security is ensured by hosting data in a dedicated server and by an intrusion detection system. Having an approval by an external committee is required for accessing data |
Communication of activities | Communication to data providers, public health policy makers and patient associations through websites, newsletters, institutional bulletins, scientific meetings and journals resulting in peer review by scientific journals and scientific meetings |
Governance | A main governing board composed by internal and external experts has a good oversight and governance mechanisms dealing with financial, administrative, ethical and legal issues, research objectives, database content, data access and use, communication and coordination of all stakeholders. |
Sustainability | Established plans to ensure durable funding and long-term sustainability |
Data quality assurance procedures | -Case definition for the Rare Disease of interest -Standardized inclusion/exclusion -Data entered/sent (online/electronically) by data providers -Data periodically updated -Application of methods to avoid data entry mistakes -Use of quality indicators -Application of methods to check for reliability, agreement and internal validity -Periodic performance of quality tests/surveys -Application of methods to avoid duplication of registered cases -Availability of instructions for use of the registry -Provision of training or of a training kit for new users |