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 |