- So, what happens if you do talk to patients?
This is Andy Robinson's data, actually published
back in 2001 now in The Lancet,
and what they did was they looked at
ulcerative colitis patients and they randomized
to an intervention group,
where they were given an hour and 1/2 to two hour
educational session about their ulcerative colitis,
versus a control group where they got regular care.
It turns out that the intervention group
treated their own relapses at home earlier
than the patients in the control group.
So the time to treat was significantly shorter
in those self-guided group, that was 14 and 1/2 hours
versus basically over two days.
The outpatient visits were down in the self-guided group,
and the time spent visiting a physician
was much less in the self-guided group,
so that maybe just even brief education and intervention
with patients actually did something
in terms of not only their disease,
but also with helping your schedule be better,
and saving money down the road.
So, what I've shown you is how to measure adherence,
and this was all prescription refill data.
Well you can do direct patient inquiry,
and we've already said that the NQF is asking
that we do that at every visit.
And if you ask, well do you take your medicine,
that's not gonna get you very far,
because patients are gonna say,
well of course doctor, yes I do.
But, hey you know, are you tolerating your medicine,
or having any problems with your medicine?
That's when you're gonna start to hear some other answers.
You can do pill counts, but that's cumbersome.
You can do metabolite levels,
and I know the pediatricians do that
for Azathioprine if they if they are wondering
if their patients are actually taking it,
but we don't do that for 5-ASAs.
It's cumbersome, it's not clinically available.
You can do it via certain scientific labs
that will do it for you.
The refill data is how most of us have done the research,
but there's electronic monitoring, as well,
and it's a nice research tool,
we're not gonna do it in clinical practice,
but I do just want to show you some data,
doing electronic monitoring.
So, this is a MEMS Cap, and the Cap looks pretty bland.
It was actually developed by a collaboration
between NASA and the national security,
not the CIA, but the the national.
- NSA. - NSA, yeah.
NSA and NASA got together and there's a microchip
embedded in this cap, and when you unscrew the cap
from just whatever bottle you put it onto,
it sends an electronic signal to a computer somewhere,
telling the time and the date that the bottle was opened.
Now this assumes that the patient's opening it
because they're gonna take the medicine that's within it.
If the patient knows there's a MEMS chip in there,
they're gonna open it every day, right?
(audience laughing)
But if they don't know there's a MEMS chip,
then you get to track how well patients
are taking their medication.
So, I've been dying to do this in IBD,
but I crossed over into the esophagus world
for a little while, and with my colleagues at Mayo,
we bought 100 MEMS caps and we did a GERD study.
So these were patients with endoscopically proven
LA Class C or D esophagitis.
So, they came in they were symptomatic,
they were scoped, they had real disease
and they were given of PPI once a day for eight weeks,
and all of them received it from the Mayo pharmacy
with this MEMS cap on there.
Because this is FDA approved therapy,
we didn't have to tell them that there was any MEMS cap
on on their therapy.
What we did was we told them that they were gonna be
part of a study to understand their medication,
and how it works in the real world.
So again, benign deception.
(audience laughing)
Then this is IRB allowed,
because we are not giving them an investigational therapy.
We are not doing it in any off label manner,
and this is the perfect patient.
So what happens is, is that when you open the cap
it sends a signal, and that you can just plot it out.
So, this is the perfect patient who on a daily basis
over eight weeks opens that cap, or opens the jar,
opens the bottle at basically the same time.
There's a little variance here,
but maybe they went out for dinner,
or were on holiday or whatever,
but you can see that basically around the same time
every day that this patient opened.
So you ready to see what we found?
Okay, this is this is a patient.
Now these are patients who came to us, they're symptomatic,
they had endoscopically proven esophagitis.
This person just opened it the first day,
and then whenever, and then the last day
before they came in for the end of the study.
So that they could write in their diary
that they had taken their medication the day before,
because they were being followed with patient diaries.
So, we have no idea what happened with that patient.
This is another patient, and so what happens is
is that we also get a line drawing of the missed doses,
but if again, if you just look at the dot graph there,
that they open the bottle on that first day,
they were very motivated.
Okay, great, I'm gonna take this PPI,
and then boy, this must have been a heck of a week
for them where they were doing something bad.
Maybe they were on vacation or something,
a lot of pepperoni pizza, but that one week,
they were taking their medication quite a bit,
and it turns out they were taking it frequently
during the day but they were only
supposed to be taking a once a day.
Then it sort of spaced out, and again, boom of course,
on the last day when they are coming back
for their exit interview.
Did you take your medicine today?
Oh yeah.
So, clearly within a trial, these are symptomatic patients,
short amount of time, once a day.
This is what people are doing.
So, to think that we're.
Yeah, Tim.
- [Tim] What if they leave the cap off?
- Well it's still only one signal,
and then it just shuts off,
and then until you put the cap back on
and then take it off again, will it will fire a signal.
(speaking too far from microphone to be heard)
Well, but we did pill counts,
'cause they had to bring back the bottle.
- [Audience] They spilled it.
- Yeah, they could have put it into the toilet, absolutely.
(speaking too far from microphone to be heard)
We asked them not to.
So we said, this is the bottle we want you to use.
I mean, maybe some of them did,
but that was something that we actually put
into the consent form, that I consent
to only use this dispenser for my medication.
So, this is electronic monitoring by MEMS.
Here is the next generation of electronic monitoring.
So this is a capsule that is hollow,
and it's got a little RFID tag on the end of it,
and you put the medicine into the capsule,
and when it hits the acidity of the stomach sends a signal.
So the patient actually has to take the medicine,
physically, and then the signal is sent.
So you don't have to worry about
whether they've opened the cap,
or whether they put it down the toilet,
and toilet water will not send the RFID signal.
It has to be the specific environment of the stomach.
The problem with trying to use this for IBD
is that the capsule is a certain size,
and you can't necessarily get the six Asacol
or the two large Lialda pills into here,
but this is where electronic monitoring science is going.
So really Big Brother type stuff here.
This is not gonna be helpful in your patients
with Crohn's who have strictures,
because even though these will.
You know, this is like doing a video capsule study,
that these will disintegrate,
but who knows if you have stricturing
where they actually disintegrate.
So, we're not quite here yet,
but I am in discussions with Dow,
in terms of how we may be able to do this
for other GI conditions.
So, where am I now?
Alan Moritsky is a social scientist at UCLA
who has developed and validated
the Moritsky Medication Adherence Score, so the MARS.
Some of you may have heard of MARS
if you read enough clinical trials.
It's an eight question survey that the patient fills out,
on their own, and it gets at how often the patient
is taking their medicine or not.
Based on their score, so you get one point for each answer,
and that you can have a score from zero to eight.
If you get a score of seven or eight,
you are considered a high adherer.
If you are six, you are considered a medium adherer,
and below six you're nonadherent.
He's done this with hypertension, and asthma,
and validated in those two chronic illnesses.
I said, hey, you know what, let's look if we can see
if we can do this with IBD.
So, Dr. Moritsky was very gracious,
and he agreed to collaborate with me
so that I didn't have to pay him anything
for the use of this of his scale.