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. 2017 Apr 5;18:163. doi: 10.1186/s13063-017-1911-x

Table 1.

The German Network Health Services Research (www.dnvf.de) criteria for assessment of registry quality. For details see [17]

Domain Item
1. Systematics and Appropriateness Registry protocol
Aims and expected benefits
Registry organization
Patient rights and data safety
Registry design
Data acquisition and processing
Data analyses, reporting and publication
Steering Committee
2. Standardization Definitions and standard operating procedures
Training for data entry and verification
3. Validity of the sampling procedure Definition of inclusion and exclusion criteria
Completeness and representativity of data
Consideration of sample size and effect
Consideration of confounders and biases
4. Validity of data collection Assessment of data: completeness, plausibility, distribution, Concordance
Handling of missing data, follow-up and dropout
Unique identifiers and risk of duplicate data entry
Monitoring and audits
5. Validity of statistical analyses and reports Patient/data flow scheme
Handling of missing data
Assessment of baseline data and outcome measures, Evaluation of balance in comparative analyses
Assessment of precision measures
Methods against bias and confounders
Adjustment for multiple inference testing
Assessment of relative and absolute effects, adjusted and Unadjusted results
Multivariate modeling for complex questions
Consideration of timeline in longitudinal data
Control of cluster effects
Validity of statistical analyses and reports
6. General demands for registry quality Transparency towards limitations
Acceptance among patients and institutions
Transparency and scientific independence
Flexibility and adaptability
Topicality