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| General and main results | Summary of results, including items based on Table 4, where appropriate | 5 |
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| Results into context: comparisons with other DUS/sources of information | Findings should be compared with other DUS from other regions/countries or other medicines in same class, or other treatments for the same indication or condition, ideally with putative explanations of any differences and similarities | 2 |
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| Results into context: relationship to regulatory decisions | Results should be discussed in the context of the regulatory approval status (on- versus off-label use in childbearing or pregnant women) of the newly approved medicine or existing treatment guidelines | 1 |
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| Limitations | Information on pregnancies
Identification of pregnancies: start date might be difficult to identify
Information on drug exposure
Drug exposure identified by prescriptions (prescribed, dispensed, or reimbursed) in secondary sources may not fully represent actual exposure due to nonadherence or irregular adherence
Not all databases have information on indication, duration of prescription
Is all exposure captured? For example, are in-hospital administrations, private prescriptions, medicines that are not reimbursed included in the data? | 4 |
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| Strengths | Nature of the database:
Size of datasets
Whole population data
Representativeness of the national or regional population
Ability to capture all types of pregnancies in the database
The database best suited to the study depends on the purpose of the study. Explain selection of database
Timing of data collection: prospectively collected data is free of recall bias | 3 |
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| Generalisability | Completeness of data source; number/extent of geographies covered
Any regional differences may be related to prescribing guidelines or custom and practice
Representativeness of overall studied population (e.g., not only the better educated, nonsmokers, and older mothers) | 3 |
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| Conclusion | Is the medicine being used by childbearing/pregnant women?
Is the medicine prescribed in primary, secondary, or tertiary care?
When in pregnancy, for how long in pregnancy, what doses, for what indications, time trends? | 2 |
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