2. Methods
The registry methodology has been published previously [19] and is
briefly summarized here.
2.1. Registry enrollment
Participation in the registry is mandatory for all US vigabatrin prescribers
and patients. Registry data are collected via SHARE-specified
enrollment forms and rules and are not part of a controlled clinical
study. Several forms (described in Section 2.2) are used to collect data
on prescriber specialty, practice location, patient demographics, and
clinical characteristics. These data are not verified, and it is not possible
to retrospectively obtain additional information fromprescribers or patients.
Patients are assigned a unique identifier to maintain anonymity.
Patients who enter the registry and report having received vigabatrin
prior to registry enrollment are identified as “exposed to vigabatrin”,
and patients who report not having previously received vigabatrin are
identified as “naïve to vigabatrin”.