Medication Adherence in Behavior Change Research Ian M Kronish MD MPH Corrine I Voils PhD Carolyn T Thorpe PhD MPH December 12 2019 SOBC Grand Rounds Speaker Series Disclosures None of the authors had any financial conflicts of interest ID: 1011702
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1. Measuring the Multiple Dimensions of Medication Adherence in Behavior Change ResearchIan M. Kronish, MD, MPH; Corrine I. Voils, PhD; Carolyn T. Thorpe, PhD, MPHDecember 12, 2019SOBC Grand Rounds Speaker Series
2. DisclosuresNone of the authors had any financial conflicts of interestThis project was supported by the National Institutes of Health2
3. Rationale for StudyEmerged from needs assessment conducted for the NIH’s Science of Behavior Change (SOBC) InitiativeSOBC Mission: To promote a mechanisms-focused, experimental medicine approach to behavior change researchResearch Network of 22 academic sites and 1 Coordinating CenterMedication nonadherence is one of the key health behaviors3https://scienceofbehaviorchange.org/
4. Scoping ReviewSystematic reviews on adherence measurement Other reviewsNIH’s GEM databasehttps://www.gem-beta.org/Public/Home.aspx4“What is the best way to measure medication nonadherence?”
5. FindingsSystematic reviews of self-report questionnairesNo consensus for specific measure1,2Other reviewsSuggest principles for good self-report measures but no optimal measure3ESPACOMP’s EMERGE initiative provides consensus on adherence reporting, but not how to select measures4NIH GEM databaseOnly 3 adherence measures listed; no recent updates1Nguyen et al. Brit J Clin Pharmacol 2015; 2Shi et al. Pharmacoeconomics 2018; 3Stirratt et al. TBJ. 2015; 4de Geest et al. Ann Intern Med, 2018 5
6. Is There a “Best” Way to Measure Adherence?Adherence is a multidimensional behaviorDifferent measures may be needed to measure different adherence behaviors6
7. GoalsObtain consensus for a framework for classifying and measuring nonadherence behaviorsIdentify recommended measurement methods for each nonadherence behavior in this framework7
8. Initial Framework: Nonadherence Behaviors8Vrijens et al. Br J Clin Pharmacol. 2012
9. Initial Framework: Nonadherence BehaviorsIncorrect ImplementationRefilling medication lateStockpilingMissing dosesTaking extra dosesTaking doses at wrong timeImproper administration resulting in incorrect doseDiscontinuationDiscontinuing the medication prematurelyNon-InitiationNot filling initial prescriptionNot taking first dose9
10. Initial Framework: Measurement MethodsSelf-reportPill/dose countPharmacy refill Biomarker Drug or metabolite level Electronic medication monitorIngestible sensorDirect observation10
11. Survey 112/15/17-1/30/2018Assess agreement with proposed framework comprised of nonadherence behaviors and measurement methods11
12. Eligibility Criteria for Experts>5 years experience in medication adherence researchInternational reputation per publications and presentationsEnglish proficiencyGeographic and discipline diversity12
13. Survey 1 Results13Response Rate: 24 of 30 (N=80%)
14. Survey 1 Respondents (N=24)Years since training23 yrs +/- 11 yrs (9 to 40 yrs)Discipline Medicine Public Health Psychology Pharmacy Nursing Statistics Other33%29%25%13%13%13% 8%Work setting Academia Government Industry Other75%17%13%13%14
15. Agreement with Nonadherence Behaviors>70% agreement for 8 of 9 nonadherence behaviors42% thought stockpiling should be removedLack of consensus for write-in responsessplitting doses, incorrect storage, not following safety precautions such as completing monitoring labs on time15
16. Revised Nonadherence BehaviorsIncorrect ImplementationRefilling medication late or not at allStockpilingMissing dosesExtra dosesDoses at wrong timeImproper administration resulting in incorrect doseDiscontinuationDiscontinuing the medication prematurelyNon-InitiationNot filling initial prescriptionNot taking first dose16
17. Agreement with Measurement Methods>70% agreement for 7 of 8 methods38% thought biomarker should be removedTwo methods to add (per write-in responses)Proxy reportEmerging tech solutions (e.g., Xhale, wrist-worn sensors)17
18. Revised Measurement MethodsSelf-reportProxy reportPrescription fill dataPill countDrug levelBiomarkerElectronic monitoringIngestible sensor Smart technologyDirectly observe18
19. Survey 26/4/2018-8/14/2018Assess agreement with revised frameworkIdentify which methods are suitable and optimal for measuring each specific nonadherence behavior19
20. Task: Rate Suitability of Measurement MethodsBehavior Non-Adherence Measurement ApproachNONINITIATIONSelf reportProxy reportRefillsPill countDrug levelElectronic monitorSmart technologyDirectly observeNot filling initial prescriptionNot taking first dose20Instructions: Rate how suitable (0, not at all suitable; 1, somewhat suitable; 2, very suitable) each measurement approach is for assessing the corresponding nonadherence behavior. Consider factors such as the reliability, validity, cost, and feasibility of each measurement method in the context of health and behavior change research
21. Task: Identify Optimal Measure for Each Behavior21Instructions: Select the measurement approach that you think is optimal for measuring each nonadherence behavior. Make no selection if none are optimal.Consider factors such as the reliability, validity, cost, and feasibility of each approach in the context of health and behavior change research.Behavior Non-Adherence Measurement ApproachNONINITIATIONSelf reportProxy reportRefillsPill countDrug levelElectronic monitorSmart technologyDirectly observeNot filling initial prescriptionNot taking first dose
22. Survey 2 Results22Response Rate: 22 of 30 (N=73%)
23. >85% Agreement with Revised Nonadherence BehaviorsIncorrect ImplementationRefilling medication lateMissing dosesExtra dosesDoses at wrong timeImproper administration resulting in incorrect doseDiscontinuationDiscontinuing the medication prematurelyNon-InitiationNot filling initial prescriptionNot taking first dose23
24. >85% Agreement with Revised Measurement Methods24Self-reportProxy reportPrescription fill dataPill countDrug levelElectronic monitoringSmart technologyDirectly observe
25. Suitable* Measurement Methods(*somewhat or very suitable)
26. Non-Initiation
27. Incorrect Implementation
28. Discontinuation
29.
30. OptimalMeasurement Methods
31.
32. ConclusionsAchieved consensus for a framework of classifying nonadherence behaviorsSuitable and optimal measurement methods varied by nonadherence behavior32
33. ConclusionsSelf-Report was the method most frequently rated as at least “somewhat suitable” But…validated Self-Report questionnaires were lacking for specific nonadherence behaviors (e.g. not take the first dose, take at wrong time)33Suitable Measures
34. Not Fill Not StartRx refill (none)DiscontinuationRx FillRefill Late Miss Dose Take Extra Wrong Time Wrong Dose Rx Fill Electronic Electronic Electronic Observe ConclusionsOptimal Measures
35. LimitationsModerate sample size of adherence expertsRationale for selections not always clearly specifiedResponses likely to vary according to research context (e.g., budget for adherence measurement, chronic condition and patient population being studied)35
36. ImplicationsThere is no “best” method to measure adherenceObjective measures not necessarily better than self-report measuresImportance of first specifying the nonadherence behavior that researchers wish to change, prior to choosing measurement methodCan apply our framework to guide the selection of measurement methods1Multiple measures need to be selected and analyzed thoughtfully1Kronish I, Thorpe C, Voils C. Measuring the Multiple Domains of Medication Nonadherence: Findings from a Delphi Survey of Adherence Experts. Transl Behav Med. 2019
37. ImplicationsIdentified gaps in measures/priorities for research:Self-report measures infrequently designed to measure specific nonadherence behaviors Self-report measures often combine questions that assess extent of nonadherence with reasons for nonadherence
38. Thank you.Contacts: Ian M. Kronish, MD, MPH, ik2293@columbia.eduCarolyn Thorpe, PhD, MPHcarolyn_thope@unc.edu Corrine Voils, PhDvoils@surgery.wisc.edu 38Citation for published paper:Kronish I, Thorpe C, Voils C. Measuring the Multiple Domains of Medication Nonadherence: Findings from a Delphi Survey of Adherence Experts. Transl Behav Med. 2019
39. Extra slides39
40. Recommended Self-Report Questionnaires (N=24; more than 1 per respondent possible) Name of ScaleFrequencyWilson’s HIV Adherence Questionnaire (3-items)4Voils Adherence Questionnaire (3-items)4Morisky Scale (unspecified; 8 item; 4-item)“Don’t use”4, 2, 11McHorney’s Adherence Estimator (3-items)3Hill-Bone Questionnaire, (8-items)2“Weinman’s Questionnaire”/BMQ (10-items)2Visual Analog Scale (1-item)1“Ability to adhere” Likert Scale with 5-6 options (1-item)1Haynes et al. 1980 Tablets missed per day/wk/mo (3-items)140
41. Reasons for Recommending SRQs41Name of ScaleReasonsVoils Adherence QuestionnaireAssesses behavior and reasons separatelyWilson’s HIV Adherence QuestionnaireValidated with electronic adherenceValidated with outcomes (HIV viral load)Rigorous development with cognitive testingPrevents ceiling effectsEase of useFreeMorisky Scale “Don’t use”ValidatedCommonly usedAllows for variabilityCombines attitudes and reasons for nonadherenceMcHorney’s Adherence Estimator Validated against claims refill dataFace validityDesigned for clinical use Ease of use including on-line platformFree
42. Name of DeviceFrequencyReasonsMEMS6long track-recordwell-validatedwell-accepted by adherence communityWisepill3wireless, enabling just-in-time interventions and remote data collectionAdhereTech1approved by institution (VA)eCAPS1affordableresemble typical pill bottleswireless versionHomemade devices (e.g., Ekstrand’s Tel-Me-Box)1No specific brand1“choice depends on lots of factors”42Recommended Electronic Adherence Devices(N=24; more than 1 per respondent possible)
43. From PA-18-722 Improving Patient Adherence to Treatment and Prevention Regimens to Promote HealthFuture studies should clearly define adherence, address intervention mechanisms of action, and compliment self-reported measures with objective assessment of behavior.43