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Table 2 Criteria of evaluation of quality of operational aspects [4]

From: An assessment of the quality of the I-DSD and the I-CAH registries - international registries for rare conditions affecting sex development

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