Sills MR. Medication Adherence PROM Measures and Self Efficacy. Slides for teleconference to facilitate discussion of Cardiovascular PRO Measure Selection by SAFTINet Stakeholders. 21 May 2012.

1. +
SAFTINet Cardiovascular
Cohort PRO: Medication
Adherence
CER Team
21 May 2012

2. +
Overview
 What medication adherence domains should we measure?
 Medication adherence: quantified
 Barriers
 Self-efficacy
 What instruments should we use?
 Who would be surveyed (PEC: all patients) and how?
 How would we use the findings in our research?
 How would our partners use the instruments?

3. +
Overview
 What medication adherence domains should we measure?
 Medication adherence: quantified
 Barriers
 Self-efficacy
 What instruments should we use?
 Who would be surveyed and how?
 How would we use the findings in our research?
 How would our partners use the instruments?

4. +
Medication Adherence Measures
 Options in SAFTINet
 self-report: simple to obtain in real time
 other real-time methods: more cumbersome and costly
 pill counts, drug levels, direct observation, etc.
 prescription fulfillment data
 in SAFTINet: only for Medicaid patients
 only tells whether they filled the prescription
Patient
(person)
Medication adherence
(behavior)
Self-efficacyBarriers

5. +
Medication Adherence Measures
 Feedback from PEC
 Medication adherence would be helpful to know
 most clinicians ask this already
 the simpler the better
 Barriers would be useful
 helped refine the list of domains to cover based on clinical
experience
 Self-efficacy—no clear direction yet from PEC
Patient
(person)
Medication adherence
(behavior)
Self-efficacyBarriers

6. +
Overview
 What medication adherence domains should we measure?
 What instruments should we use?
 Medication adherence: quantified
 Barriers
 Self-efficacy
 Who would be surveyed and how?
 How would we use the findings in our research?
 How would our partners use the instruments?

7. +
Review of Self-Reported Medical
Adherence Measures
 Garfield S, et al. Suitability of measures of self-reported
medication adherence for routine clinical use: A systematic
review. BMC Med Res Methodol. 2011; 11: 149.
 Inclusion Criteria: Studies that report development, reliability or
validation of a retrospective self report adherence measure
against a non-questionnaire measure
 Exclusion Criteria: (excerpt)
 non-English
 no instrument available
 only relevant to single disease or medication
 med adherence questions not separable from other questions

8. +
Review findings
 58 measures in 76 papers
 Length: 1 to 21 questions
 Formats: face to face interview, telephone interview, self
administration and computer program
 43/58 specified a time period
 ~half had a measure of barriers too, but these were usually not
comprehensive or developed with patient feedback
 54/58 had validation data

9. +
Overview of studies by design

10. +
Overview of studies by validation

11. +
Narrowing down the field
 Selected studies with only 1 question: 21/58
 Selected studies with significant findings for validation study:
16/58
 Selected studies not limited to an HIV positive or Mental Health
population: 5/58
 Rationale: focus on less symptomatic population

12. +
Scale
[Ref #] Scale type Time period Sample size Population
Validated
against
Validity
Results
Adherence
Self Report
Questionnair
e (ASRQ)
[25-27] Likert
None
Specified 245
Patients from
GP practice
taking
antihyperten
sives MEMS
Significant
association
(p=0.0004)
216
Patients from
GP Practices
taking
antihyperten
sives MEMS
Sensitivity=
46%;
Specificity=6
6%
Gehi [41] Likert
Previous
month 1015
Outpatients
with
documented
chronic heart
disease
Develop-
ment of CV
events
Significant
association
(p=0.03)
bivariate
analysis,
0.06
multivariate
analysis)
Inui [46] Dichotomous
Previous 2
months 241
Patients with
HTN Pill count
Sensitivity =
55%;
Specificity =
88%

13. +
Scale
[Ref #] Scale type Time period Sample size Population
Validated
against
Validity
Results
Medical
Outcomes
Study
Adherence
question [57] Likert
Previous 4
weeks 139
Patients >18
with HTN,
DM, hyper-
cholesterole
mia, hypo-
thyroidism or
requiring
HRT
Pharmacy
refill records
Spearman
Rho=
0.261(p=0.05
)
Visual
Analogue
Scale (VAS)
six month
version [89]
Continuous
(visual
analogue)
Previous 6
months 1985
Patients >18
with DM MEMS
VAS higher
than MEMS
adherence
mean
difference
15% (p value
not reported)

14. +
Adherence Self Report
Questionnaire (ASRQ)

15. +
Gehi Question
 In the past month, how often did you take your medications as the
doctor prescribed?
 “All of the time” (100%)
 “Nearly all of the time” (90%)
 “Most of the time” (75%)
 “About half the time” (50%)
 “Less than half the time” (<50%)

16. +
Medical Outcomes Study
Adherence question
 How often have you taken your prescribed medication in the
past 4 weeks? (Select one)
 none of the time
 a little of the time
 some of the time
 a good bit of the time
 most of the time or all of the time
 Similar to Gehi question

17. +
Inui Question
 Many patients find it difficult to take their medicines
or stick to their diets as their doctors say they
should. Over the past two months since you were
last in clinic, do you think you have taken your
medicine as you should, on schedule and regularly?
 Yes
 No

18. +
Visual Analogue Scale (VAS) six
month version
 What percent of time over the past 6 months did you take your
prescribed diabetes medication?
 Place an “x” on a horizontal line
 anchored by 0% and100%
 demarcations provided for every 10th percentile

19. +
Self-Reported Medical Adherence
Measures
 Recommendations on selecting a measure quantifying
medication adherence?
 Adherence Self Report Questionnaire (ASRQ)
 6 levels, more text per level
 Gehi Question
 5 levels, brief text and percentages for each level
 Medical Outcomes Study Adherence question
 5 levels, brief text for each level
 Inui Question
 yes/no question
 Visual Analogue Scale (VAS) six month version

20. +
Medication Adherence from Claims
Fulfillment Data
 Medication possession ratio (MPR) = (days of medication
supplied) ÷ (# days between the first and last fills)
 Proportion of days covered (PDC): the proportion of all days
within a specified time period a patient had enough medication
 Percentage of doses taken as prescribed: the percentage of
prescribed doses taken as directed during a specified time
period
 Cumulative medication gap (CMG) = (# days in which a
medication was not available) ÷ (# days between the first and
last fills)

21. +
Overview
 What medication adherence domains should we measure?
 What instruments should we use?
 Medication adherence: quantified
 Barriers
 Self-efficacy
 Who would be surveyed and how?
 How would we use the findings in our research?
 How would our partners use the instruments?

22. +
Medication Adherence Measures:
Barriers Measure
 Starting point for which barriers to ask about
 what barriers have been shown to matter in research studies
 what barriers do you encounter in your own practices (known to be
very context dependent)
 emphasize barriers that are amenable to real-world intervention
(e.g., prescribe a daily rather than twice-daily medication)
Patient
(person)
Medication adherence
(behavior)
Self-efficacyBarriers

23. +
Medication Adherence Measures:
Barriers Measure
 Starting point for which barriers to ask about
 what barriers have been shown to matter in research studies
 RAND Corporation systematic review of barriers found to predict
measured medication adherence
 regimen complexity
 cost-sharing (e.g., prescription copayments, formulary tiers,
coinsurance, pharmacy benefit caps or monthly prescription limits,
formulary restrictions, and reference pricing)
 depression (found effect only as comorbidity of diabetes)
 beliefs about medications (perceived risks of having a side effect
and perceived impact and need for the medication)

24. +
Medication Adherence Measures:
Barriers Measure
 Based on the RAND list, and eliminating depression, here is a
sample barriers measure, modified by PEC
 Which of the following things make it harder for you to take
your medication(s) as prescribed?
 I am worried about the side effects of the medication(s)
 I do not feel like I need the medication(s) for my health
 I do not feel like the medication(s) make me feel any better
 It is hard to take medication(s) more than once a day
 I have so many medications to take
 I cannot afford to pay for the medication(s)
 I sometimes forget to take my medication(s)

25. +
Medication Adherence Measures:
Barriers Measure
 No systematic review of barriers measures
 Per PubMed, the ASK-20 and ASK-12 are
 commonly cited
 not disease specific
 validated
 ASK-12
 contains the questions most often identified as barriers by patients
taking the ASK-20
 Three domains – Inconvenience/forgetfulness, Treatment beliefs,
Behavior – each with a subscale

26. +
Medication Adherence Measures:
Barriers Measure
 ASK-12 total score demonstrated adequate internal consistency
reliability with a Cronbach’s alpha of 0.75
 ASK-12 score correlates with self-report measures and objective
measures
 Morisky Adherence Survey (-0.74)
 proportion of days covered as indicated by claims (r=-0.20; P=0.059)
 Score
 range 12-60
 higher score = greater barriers
 In a clinical setting it is not necessary to score the instrument, only
review the items in the dark blue boxes

27. +
Medication Adherence Measures: ASK-
12

28. +
Medication Adherence Measures: ASK-
12

29. +
Overview
 What medication adherence domains should we measure?
 What instruments should we use?
 Medication adherence: quantified
 Barriers
 Self-efficacy
 Who would be surveyed and how?
 How would we use the findings in our research?
 How would our partners use the instruments?

30. +
Medication Adherence Measures: Self-
efficacy
 Medication Adherence Self-Efficacy Scale (MASES)
 Ogedegbe et al 2003
 Validated in African-American patients with hypertension
 Please rate how sure you are that you can carry out the
following tasks ALL OF THE TIME: (all answers are on a 3
point scale: Not at all sure, somewhat sure, very sure)
 Get refills for your medications before you run out
 Make taking your medications part of your routine
 Fill your prescriptions whatever they cost
 Always remember to take your blood pressure medications
 Take your blood pressure medications for the rest of your life

31. +Situations come up that make it difficult for people to take their medications as prescribed by their
doctors. Below is a list of such situations. We want to know your opinion about taking your blood
pressure medication(s) under each of them. Please indicate your response by checking the box that
most closely represents your opinion. There are no right or wrong answers. For each of the
situations listed below, please rate how sure you are that you can take your blood pressure
medications ALL OF THE TIME
1. When you are busy at home
2. When you are at work
3. When there is no one to remind you
4. When you worry about taking them for the rest of your life
5. When they cause some side effects
6. When they cost a lot of money
7. When you come home late from work
8. When you do not have any symptoms
9. When you are with family members
10. When you are in a public place
11. When you are afraid of becoming dependent on them

32. +
Overview
 What medication adherence domains should we measure?
 What instruments should we use?
 Medication adherence: quantified
 Barriers
 Self-efficacy
 Who would be surveyed and how?
 How would we use the findings in our research?
 How would our partners use the instruments?

33. +
Options for Med Adherence PRO
Administration
 Easier to administer to all patients than to only those with select
diagnoses
 Having just one screening question is more practical
 Administer medication adherence measure first
 then administer barriers +/- self-efficacy questions
 only administer barriers +/- self-efficacy questions to those with non-
adherence
 Administer barriers +/- self-efficacy questions first and leave the
medication adherence question for last

34. +
Overview
 What medication adherence domains should we measure?
 What instruments should we use?
 Medication adherence: quantified
 Barriers
 Self-efficacy
 Who would be surveyed and how?
 How would we use the findings in our research?
 How would our partners use the instruments?

35. +
Research Utility
 Which domains would we use?
 medication adherence
 barriers measure total score
 self-efficacy total score
 How would we use these in an analytic model?
PCMH
Medication adherence
Self-efficacyBarriers
Disease control

36. +
Research Utility
 How would we use fulfillment data in an analytic model?
 Verify self-report data
 As an outcome or intermediate variable in the PCMH model
PCMH
Prescription fulfillment
Disease control

37. +
Overview
 What medication adherence domains should we measure?
 What instruments should we use?
 Medication adherence: quantified
 Barriers
 Self-efficacy
 Who would be surveyed and how?
 How would we use the findings in our research?
 How would our partners use the instruments?

38. +
Utility to Practices
 Which of the components of the proposed PRO would have
clinical (and other use) utility to the practices?
 What related activities are the practices already doing?
 Some clinicians are asking about medication adherence and
barriers but not documenting responses in a field
 Nurses check the list of active medications at intake, asking which
they are still taking and why they stopped those they are no longer
taking
 Meaningful use phase 2 will require goal-setting and a barriers
format might meet these criteria
 ACO activities related to identifying high-risk patients for
hospitalization (next slide)

39. +
Example of Medication Adherence
Question Already In Use
 How many prescription medications are you currently taking every day
(H-8)?
 None (0) (skip to Social Needs)  1-2 (0)  3 OR MORE (1)
 In a TYPICAL WEEK how often did you forget to take or decide NOT to
take one or more of your medications (H-8)?
 NEVER (0)  RARELY (0)  SOMETIMES (1)  USUALLY (1)  ALWAYS
(1)
 How sure are you that you understand the reason you are taking your
medications (H-8)?
 VERY SURE (0)  SOMEWHAT SURE (0)  NOT VERY SURE (1)
 How often do you get your medications at more than one pharmacy?
 NEVER (0)  RARELY (0)  SOMETIMES (1)  USUALLY (1)  ALWAYS
(1)