DEPARTMENT OF THE AIR FORCE59TH MEDICAL WING (AETC)

JOINT BASE SAN ANTONIO - LACKLAND TEXAS

26 APR 2017

MEMORANDUM FOR SGSPATrN: MAJ SHAOPING MO SUMNER

FROM: 59 MDW/SGVU

SUBJECT: Professional Presentation Approval

1. Your paper, entitled Assessing Medication Adherence in Patients with RheumatoidArthritis (RA) presented at/published to Texas Society of Health-Systems PharmacistsAlcalde Southwest Leadership Conference, Galveston TX, 26-17 April 2017 inaccordance with MDWI 41-108, has been approved and assigned local file #17209.

2. Pertinent biographic information (name of author(s) title, etc.) has been entered into ourcomputer file. Please advise us (by phone or mail) that your presentation was given. Atthat time, we will need the date (month, day and year) along with the location of yourpresentation. It is important to update this information so that we can provide qualitysupport for you, your department, and the Medical Center commander. This informationis used to document the 'scholarly activities of our professional staff and students, which isan essential component of Wilford Hall Ambulatory Surgical Center (WHASC) internshipand residency programs.

3. Please know that if you are a Graduate Health Sciences Education student and yourdepartment has told you they cannot fund your publication, the 59th Clinical ResearchDivision may pay for your basic journal publishing charges (to include costs for tablesand black and white photos). We cannot pay for reprints. If you are a 59 MDW staffmember, we can forward your request for funds to the designated Wing POC at the ChiefScientist's Office, Ms. Alice Houy, office phone: 210-292-8029; email address:alice.houy .civ@mail.mil.

4. Congratulations, and thank you for your efforts and time. Your contributions are vital tothe medical mission. We look forward to assisting you in your futurepublication/presentation efforts.

LINDA STEEL-GOODWIN, Col, USAF, BSCDirector, Clinical Investigations & Research Support

Warrior Medics - Nlission Ready - Patient Focused

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Assessing Medication Adherence inPatients with Rheumatoid Arthritis (RA)

Shaoplng Mo Sumner, Maj, USAF, PharmD

San Antonio Combined Military Postgraduate Year OnePharmacy Residency Program .......••Fort Sam Houston, TX

Brooke Army Medical Center' (BAMC).4

BAMC: San Antonio Military Medical Center (SAMMC) plus 5 freestanding primary care clinics

Only 000 Level 1 Trauma Center425-bed medical facility

Army Institute of Surgical Research

• DoD Bum Center• Battlefield Trauma Centers ofExcellence

89 Accredited educational programs

35 Primary a!",d specialty care services

32 Sub-specialty clinics

Average 4500 outpatient prescriptionsdaily

Disclaimer

This research has been approved by the Brooke Army Medical CenterInstitutional Review Board.

"'Theview(s) expressed herein are lhose of the author(s) and do notreflect the official policy or position of Brooke Army Medical Center, theU.S. Army Medical Department, the U.S. Army Office of the SurgeonGeneral, the Department of the Air Force, the Department of the Armyor the Department of Defense or the U.S. Govemment:

Neither my spouse or I have any financial interesVarrangement.affiliation or relationship with one or more organizations that could beperceived as a real or apparent conflict of interest in the context of thesubject of lhis program

Learning Objectives

At the completion of this program, the participant will be able to

• Identify oral RA-specific drug lrealmenl options

• Differentiate the two medication adherence instruments

• Analyze the correialion between the two instruments

1

Background

• Rheumatoid arthritis

- Affecting 1-3 million Americans

- Seventy percent are women

- Associated with higher risk of heart disease and stroke

~~qI~~~""J.,fw'f>':"1(H,~cg.-!.py..=... •••"'. ";IO.,.•••'~~j~on2J~2(n8

D Background .AI iii!! ~.

• Patient adherence to DMARDs may be adverselyaffected by

- Slow onset to symptom relief

- Intolerable side effects

• Medication adherence and compliance are usedinterchangeably

- Adherence is a preferred term

- Actively participating

~ ••• B"'C•••~o.cwo.r20'J'."ll8~ ••• NE'9J~2OO!'I,J53487-i7

Vovng~~2008."'f.2'~ •••• BMC20U1.2ae

Background

• Non-adherence rate to DMARDs up to 80%

• Higher healthcare cost, decreased quality of life

• Two instruments assessing medication adherence

- Compliance-Questionnaire-Rheumatology (CQR)

• Original 19-item version (CQR19)

• New 5-item version (CQR5)

- Morisky Medication Adherence Scale (MMAS8)

2

Comparisons

MMAS8 Sample Questions

1 for No; 0 for Yes, except the last question(never/rarely, once in a while, sometimes, usually,always, 1,0.75,0.5,0.25,0)

~0E.'"'''JClInE~O'',S.282_2t13

CQR Sample Questions

Don't agree at all; Don't agree; Agree; Agree very much(1-4 points, respectively)

Purpose and Objectives

Purpose: Assess medication adherence in patients with rheumatoidarthritis

Objectives:

1. Primary: Assess whether there is a correlation between CQR19 andMMASB

2. Secondary: Determine if there is potential medication adherence issuein patients with RA laking oral DMARDs, and the correlation betweenCQR5/19 and MMASB

3

Research Design & Methods Methods

• Prospective cohort study • An 80% power was used to detect a correlationcoefficient of 0.2 to get estimated sample size of 102

• Data collection and processing- A combined questionnaire from CQR19 and MMAS8 was

provided to patients upon check-in- Completed surveys were collected in designated drop boxe- Primary investigator collected them at the end of each day- Continued for 6 weeks

Cohort Demographics

Results

4(50)42(525)27(337)7 (8.8)

Mean (SO)

54 (138)53(14 l'58(138)

10(" 2)

Median (lOR)

8(6)

2(2)

Number(%)

lOR If'llerquar1lle range

AQe (n:80)Female, 62 (77%)M.s, 18 (23%)

Ou'atJon of RA. years (n=75)

Number 01 aI medications (n-75)

Numbe' 01 Ofal RAmlldlc.bons (noSl)

Self-descnbed Healttl (n"80)POO<Fo.WeIVery WilD

1m Statistical Analysis A.

• Spearman rank-order correlation- Variables are ordinal or continuous- Linear (monotonic) relationship

- The null hypothesis is that the correlation between twoinstruments is zero

• Chi-square (or Fisher's exact) test used to show if thegroup assignments are associated

4

Results

Spearman Correlations for Adhe~ence/comPII~nce Predictor S~ore_s

Comparison Groups

MMAS8-COR19 laking complianceMMAS8-COR 19 dosing compliance

CQR19 taking/dosing compliance

P (rho)

0.2680.2960.842

p- value

0.Q150.007<0,001

Interpretation

Weak-SlgniflCsnt

Weak-Significant

Strong-Significant

MMASB Adherence

MMAS8 Adherence

MMASB Adherence

CQR19 Takln Com IianeeCQR19 Dosing Compliance

Results

CQR19 Taking Compliance

CQR19 Dosing Compliance

CQR5CQR5CQR5

8.3409

6.94621-668838.8934.33

0.017"

0.028"0.454"<0_0001

<0.0001

Roundtree 119811

Predictor and Groups t Number (%)

Secondary Outcomes

• MMAS6 and CQR19 taking anddosing scores were significantlycorrelated

• CQR19 taking and dosing scoreswere significantly correlated

MMAS8 AdherenceHighMediumLow

COR19 Taking ComplianceHighLow

COR 19 Dosing ComplianceHighLow

CQRS AdherenceHighLow

<0.20

0,20-0.40

0.4-0.70

0.70-0.90

>0.90 .

7 (8.5)32 (39.0)43 (52.4)

41 (50)41 (50)

26(31.7)56(68.3)

29 (35.4)53 (64.6)

Vrrywtilk

Weak

Moder;lte

Strona

VerySlronl

• Fisher'. 1txllC1 test

• MMAS8 and CQR19 taking and dosing group assignments weresignificantly associated

• MMAS8 and CQRS group assignments were not associated

• CQRS and CQR19 taking and dosing group assignments weresignificantly associated

g Conclusions .A" Although CQR19 and MMAS8 scores were only weaklycorrelated, adherence groups assignments were similar

" The ability of CQRS and MMAS8 to predict adherencegroups assignments were not similar

" The ability of CQR19 and CQRS to predict adherencegroups assignments were similar

" Further study needed to recommend MMAS8 as areplacement for CQR 19

" All four predictor estimates identified high levels of potentialDMARD non-adherence with predictions ranging from 50%to 68%

5

= Limitations and Future Directions ••.lia

LimitationsLimited population to one siteMight be subject to recall biasPatients filled out the form incorrectlylincompletely

Future DirectionsInclude more than one treatment facilityProvide data indicating the potential extent of non-adherence. May serve as a baseline for further research

Assessment Questions

2. The Morisky Medication Adherence Scale wasdeveloped to assess medication adherence intent andhas been validated in several common diseases,including RA.

A) True

B) False

fJ Assessment Questions Atll:;il

1. Oral Rheumatoid Arthritis-specific drug treatmentsinclude which of the following

A) IV biologic agents

B) Diseasemodifyinganti-rheumaticdrugs (DMARDs)

C) Glucocorticoids

D) Band Conly

Assessment Questions

3. The terms compliance and adherence are usedinterchangeably, but adherence is the preferred termsince it implies active participation of the patient.

A) True

B) False

6

e Acknowledgements A• This project would not be possible without theguidance, support, and assistance of the followingpeople

- Dr. Annabel Schumaker, PharmO, BCPS- Dr. Tom Shank. PharmO- Dr. Irene La, PharmO, BCPS

- Dr. Sca" HOluby,PharmO, BCPS- Siaff al Ihe Rheumatology Clinic- Everyone else who has supported me through my residency

g References ~

RA 'aet5-stlltlstJc~O. tmr> I/',"'''rw ~:!1J.!I.!!L~COf!'I!:h"'l!hI'h!t'Jlflalotd:Blltwl!rsIl'9CtriWtl)tx.'Ir-~. Accessed on 30 AuQu5t. 2016Ellabeth Sail Sus.an FrlWef, "Adherence to DIS.au ModrtyIng Anti-RheumatIC Drugt. nRl'wtumatoid Arttvltil pabents II narratrve review of the literature', Orthop Nurs, 2010: 29 (4)"260-275

Amenc.n Col.g. of Rheumatology, http l1otf'.'w rheym~')9TJ 9'Si:'l.Am-NF-i!l'>~n1~, •.."IQn.ea:;ts-COO41!i?~~ keened on 23 Seplembe,. 2016Hughes tltal. A 5 Item verSIOn of the Compliance Qun1lOl'VUltre tor Rheumlltology (CORS)succentulty Identrfies low adherence to OMARO& 8MC Musculoskeletal DISorders 201314:288

Young A CUl'TIln1approaches 10 drug treatment n rheumatoid arthotls Prescriber 2008, 19: 19-28WHO (2003) Adherence 10 long-term therapies: evidence lor action Retneved from~,:!l't.,j~!l¥..i.01t.llN4!l:"9.::'!!lL~!' __ iY. .<1r!!L~~....1~i'~~. Accessed July 31, 2016DIMatteo MR. Variations If'lpallenls' adherence to medical recommendations: a quantitativereVIew of 50 ~e~s 01 re.ewch Med Care 2004,42200-09 .

!1 Contact Information ••For additional information contact me at:

shaoping.m.sumner.mil@mail.mil

ft1 References A.Cramer JA. Roy A. B1Irel A. FawchikJ CJ, F~eOle MJ. Otlendorl OA. et" MedlcalJOtlcomp~ance and persistence terminology ~ def1MJom. Value He~ 2008.11 44 ...•7Servers et al Auessing Selt.feported MedICation Adherence.., Inflammatory Bowel [Mease AComparison ofTool$ Innamm Bowel 016 2016,0 1-7Osterberg L. Blaschke T. Adherence to MedICallon. N Eng! J Med 2005,353 487-97Morll>kyDE. Green LW. Levrne OM Conc16fent and pt'ed!CtJve validity 01 a self.,eportedmeaSlle 01 medICation adherence Med Care 1966.2467_74Morl6ky DE. OJMalteo MR Improving the measurement of ult.,epor1ed medICationnonadherence Final response J Clin Epidem.ol 2011.64262-263de Klerk E. van der He'lde D. Landewe R. van der Tempel H, van der linden S Th.ComphiAnCe.QuubolV\il ••• Rheumatology compwed wrIh electronIC medicatIOn eventmorvtorng • validation study J Rheumalal 2003;30:2469-75

7

Questions

8

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PLATFOR PRESE TATIONS

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