Data Collection
ADVERSE EVENT
Demographic and clinical data were collected either directly from patients or abstracted from the patients’ medical and pharmacy claims in the health plan’s administrative claims database and entered into the electronic Case Report Form (eCRF) by trained study personnel. Comorbid conditions in the medical claims were identified using previously described methods based on ICD-10-CM [The BF-ADL upper limb scores were collected using patient surveys administered on the e-consent platform at baseline and the end of one month. The eight BF-ADL upper limb tasks assessed were to (1) use a spoon to drink soup, (2) hold a cup of tea, (3) pour milk from a bottle, (4) dial a telephone, (5) pick up change, (6) insert an electric plug, (7) unlock front door, and (8) write a letter. Each task was rated on a scale of 1 (“able to do the activity without difficulty”), 2 (“able to do the activity with little effort”), 3 (“able to do the activity with a lot of effort”), to 4 (“cannot do the activity by yourself”) [Adverse events (AEs) were self-reported by patients and were entered into the electronic Case Report Form (eCRF) by trained study personnel.