Overview
StudyTRAX has a built-in "Medications" feature design to tightly integrate data entry of subject medication usage with datasets, including dose equivalency scales. There is a central list of Medications that is maintained by the "Medications" user role. The central list of medications may involve just a few, targeted medications or thousands of medications (e.g., the entire PDR). Medications are "global" meaning once a medication is entered for a subject that information is available across all studies with which they are involved. For example, morphine 100mg is entered for a patient X in a patient registry and patient X is also in a clinical trial. In this case, the use of the medication is automatically available within the trial.
How It Works
The "Medications" feature is often used with patient registries and/or to collect concomitant medications for clinical trials. It combines simple entry for data entry staff with sophisticated analysis of medication usage for investigators. From the perspective of data entry staff, medications are entered by merely selecting from a list and then entering in the applicable begin date (end-date if applicable), dose, times pre day, route of administration, indication, and any notes. From a data analysis perspective, medication usage in datasets is automatically looked-up and connected with visit dates (e.g., date of a clinic visit, planned protocol encounter dates such as baseline, week 1, week 4, etc.)! In datasets, investigators can choose to include 1) the dose of a specific medication, 2) the dose equivalence across multiple medications, and/or 3) whether a patient has ever been exposed to a single or a whole list of medications (see image below).
Integration of Medications In Data Sets
Common Questions and Answers
- What if a medication is taken on a different dosing schedule within the same day?
- Since data analysis is at the "Day" level, whether or not this is one or two entries depends on whether the information is needed. For example, those with patient registries may prefer two entries because they are using StudyTRAX to generate clinic notes and the specificity is needed. Conversely, those only interested in the daily total may combine it into one total dose entry.