Add medications module

[mrueschman]

Medications are collected in almost every project we work on. Most studies maintain a single "log" of medications, to which study staff return to on follow-up phone calls and visits to edit/update accordingly. This is "doable" with a Design in Slice, though it doesn't necessarily "fit" well into the typical flow (e.g. what "event" houses the log when it is edited over the course of many events).

A separate module would accomplish a few things:

• Promote consistent collection of medications (with some customization per project still possible)
• Provide more straightforward means to "review" and update the log
• Provide a consistent way in which medications are exported

Here's an example paper log I found on Google:

A brief synopsis of what I'm envisioning:

Setup Phase

• (v71) Enable "Medications Module" on project-level
• (v71) Go to Medications Module to configure
• (v71) First step is to construct medication log and publish (like a randomization scheme, sort of .. locking medications collection in place (to some degree))
• (v71) Pick and choose what fields you want to collect from a hard-coded list. Medication name, indication, dose, unit, frequency, route, start date, stop date.
• Choose when log becomes required: options include "When subject is created (default)" and then list of existing events (e.g. Baseline). We may only want medications on subjects when randomized, so don't show medications module for subjects who haven't reached that event yet.
• Choose suggested review interval: Monthly, quarterly, semi-annually, etc. How often do we anticipate medications being reviewed? If medications progress beyond throw some sort of warning flag on the subject page to indicate that medications should be reviewed.

Log Creation Phase

• When subject meets criteria for log to show up, Medications tab becomes available.
• (v71) Clicking in there will then say, "Medication log is empty. Click to start medication log."
• User clicks, starts filling in data. 5 medication rows by default (showing pre-selected fields), allows for user to add more if needed.
• Should have option for, "Subject was not taking any medications", which allows an "empty" log to be saved (but still tells us that medications were checked).
• User saves log. Now when in the subject-medications section it says at the top, "Medications log last created on [date that log was just created] by [staff member who entered]." The log is shown as a table below that. The log could be edited at that point (maybe entries could be edited in-line instead of swapping edit/show pages).
• Presumably visit ends, log is now going to move into "review" phase.

Log Review Phase

• (v71) User returns some time later when subject is on follow-up phone call. User clicks button "Review medications", at which point Slice does something more fancy than simply putting the current log into edit mode. Slice goes through existing medications and poses question to user, "Is subject still taking [this medication at this dose/frequency, blah blah spitting back existing information we have]?" If yes, Slice moves on to next medication and leaves that row of log alone. If "No, something changed with this medication" then automatically fill in "Stop Date" for existing row and start a new row for same medication and give user opportunity to fill in the "new" information (like dose changes from 100mg to 50mg). If "No, stopped taking medication entirely" then fill in "Stop date" and move to next row.
• At conclusion of review, medication log page now at top says, "Medication log last reviewed on [date] by [user]."
• Process repeats at subsequent follow-up. Slice only "asks" about non-stopped medications at each review.

Exports

• (v71) Export medications CSV.
• Export medications history? Like log of creations and reviews? Not necessarily transaction-level audits, more a timeline.

[michellereid]

Medications will be assessed at screening / consent, at baseline (if only medical status has changed in the two weeks between screening / consent and baseline), and all subsequent visits (phone calls and in-person visits).
The CRF hasn't been sign-off yet but right now it has name, strength, dose amount, dose type, frequency, start date and end date

In the log review phase, in addition to creating a new row if i.e. the dose changes - we also want the capability to enter in completely new medications regardless if previous medications are ongoing or have stopped.

For the start and stop dates - is there a way to enter 99 or a obvious way to indicate that part of the date is missing?

Also, for the medication names is there a way to have an autocomplete values? I am obtaining a list of common HF meds now but I would hate to get to the data cleaning stage and have issues of misspelling, generic vs. brand names etc.

[mrueschman]

Thanks! Yes, at the end of the review the question, "Have you started any new medications since our last review on [last review date]?", should be asked, allowing for any number of new meds to be added at that time.

We should contemplate how to capture start/stop dates in different "states", e.g. full dates, only month-year, or unknown.

I would suggest adding "OTC/Rx" to CRF and an "indication" type field to the CRF itself; I think these could be useful and I saw them on some other logs.

Yes, I would want to have an autocomplete for the name field. We may need to "enhance" autocompletes generally to allow for very large lists to be used, like in medication names and MedDRA lists.

[remomueller]

@mrueschman, @michellereid, about half of this issue is coming in with v71, but some of the changes will only be added in a future release. I'll keep this issue open, but remove it out of the v71 milestone, as it makes a bit more sense to keep everything grouped together for the time being. I've also added which items were done in v71 in the original issue.