Page Comparison

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• What if a medication is taken on a different dosing schedule within the same multiple times on the same day?
  • Since data analysis is at the "Day" level, whether or not this is one or two multiple entries depends on whether the information is neededit is consider important to separate the information.  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  patient registry designs may prefer multiple entries because the information is used to generate clinic notes within StudyTRAX.  Conversely, a research design may only have an the total daily dose and thus combines this into one total dose entry.
• Should I use the medication feature or create a concomitant"Concomitant Medication" CRF?  
• The time saving analytical routines of the Medications feature nearly always trumps building a separate concomitant medications form and handling data collection just like another form.  Because the fields Concomitant Medication case report form (CRF).  However, because the fields of the Medication feature are hard coded, in some cases research groups will create a separate form cases a separate CRF is created because there is an interest in a broad range of specific medication in medication usages characteristics (e.g., was it titrated, did another medication have to be stopped were there any Adverse Effects in the first 24 hours, etc.).
• What if a medication is not taken every day (e.g., PRN)?
  • What to do depends on the aims of the study/registry.  For instance, if total prescribed dose is what is of interest, then it is entered as if taken every day.  If the "mean daily dose" is what is of interest, then that is what is entered for dose (i.e., once a dayan estimated average over a set number of days.  Once calculated, the mean dose is entered as "daily").  If documentation of usage is what is of interest, then enter the total dose and put PRN in the notes.  The main thing to consider is StudyTRAX pulls whatever is entered into the dose field into data sets, thus analytical concerns mainly drive the decision.
  What if the start date isn't known?
• Missing information?
• Start and End date.
  • What to do depends of the aims of the study.  Some examples:
  If the patient is currently
  • • • Subject on
  the
  • • • medication
  and they don't when they started, if
  • • • , but don't know start date:  In this case, if the research question of interest is length of time on the medication, then adopting a
  rule for a conservative estimate is recommended (i.e., the most conservative being the day of the visit). 
  • • • conservative estimation rule is recommended.  The meaning of "conservative" will varying depending on the aims of the study, but generally it would be defined to work AGAINST the hypothesis so that the investigator is confident the results minimize type I errors.
      • Subject knows the year, but not month: Same as above in terms of adopting a conservative rule.  That is, work against the hypothesis.  Typically one of the following is adopted: "1/1/xxxx", "6/1/xxxx", or "12/31/xxxx". 
  • Medication Dose
  • If the dose is not known, documentation vs. analytical aims will drive the decision.  That is, if there is no need to document the use of the medication it would NOT be entered, or if it does need to be documented 0 is entered.  On the analytical side of things, typically a conservative rule is adopted  (e.g., in a retrospective study, the medication is mentioned in the EMR, but not dose, use the smallest known dose).
  • Number of times per day
    • Handled the same as missing "Dose".  A "0" is entered if only needed for documentation.  For analytically purposes, the conservative rule is often set to "enter 1".