The US Agency for Health Care Research and Quality (AHRQ) published a comprehensive document on ‘good registry practices’ entitled Registries for Evaluating Patient Outcomes: A User's Guide, 3rd Edition, which provides methodological guidance on planning, design, implementation, analysis, interpretation and evaluation of the quality of a registry. There is a dedicated section for linkage of registries to other data sources. The EU PARENT Joint Action developed methodological and governance guidelines to facilitate cross-border use of registries.
Results obtained from analyses of registry data may be affected by the same biases as those of studies described in section 5.2 Bias and confounding. Registries are particularly sensitive to the occurrence of selection bias. This is due to the fact that factors that may influence the enlistment of patients in a registry may be numerous (including clinical, demographic and socio-economic factors) and difficult to predict and identify, potentially resulting in a biased sample of the patient population in case the recruitment has not been exhaustive. In addition, studies that use registry data may also introduce selection bias in the recruitment or selection of registered patient for the specific study, as well as in the differential completeness of follow-up and data collection. It is therefore important to systematically compare the characteristics of the study population with those of the source population.
The randomised registry trial is a new study design that combines the robustness of randomised studies with the higher generalisability of registry data, see section 5.6.3.
|10. Specific topics|
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|