Treatment adherence research
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1 June 7, 2012 Treatment adherence research Line Guénette, PhD Sophie Lauzier, PhD Jocelyne Moisan, PhD Jean-Pierre Grégoire, PhD Gabriel Giguère, MSc candidate Amine Amiche, MSc candidate Hervé Zomahoun, PhD candidate Faculty of pharmacy, Laval University, Quebec, QC, Canada Chair on adherence to treatments, Laval Universisty, Quebec, QC, Canada Unité de recherche en santé des populations, Centre de recherche FQR-S du Centre hospitalier affilié universitaire de Québec, QC, Canada.
2 Drug development phases YEARS INTRODUCTION REGISTRATION DEVELOPMENT BASIC RESEARCH CLINICAL TEST (HUMANS) ,000-10,000 QUANTITY OF SUBSTANCES SURVEILLANCE PRECLINICAL TEST (ANIMALS) SYNTHESIS, EXAMINATION & SCREENING PHASES IV III II I Source: Based on PhRMA, updated for data per Tufts Center for the Study of Drug Development (CSDD) database. 2
3 Drug development phases DRUG USE, ADHERENCE? YEARS INTRODUCTION REGISTRATION DEVELOPMENT BASIC RESEARCH CLINICAL TEST (HUMANS) ,000-10,000 QUANTITY OF SUBSTANCES SURVEILLANCE PRECLINICAL TEST (ANIMALS) SYNTHESIS, EXAMINATION & SCREENING PHASES IV III II I Source: Based on PhRMA, updated for data per Tufts Center for the Study of Drug Development (CSDD) database. 3
4 Laval s Chair on adherence to treatments Jean-Pierre Grégoire Sophie Lauzier Jocelyne Moisan
5 Organisational flow chart Chair holder J.Moisan Steering committee OPQ UL INESSS Scientific committee J.-P.Grégoire L.Guénette E.Kroger S.Lauzier Committee of sponsors Merck AstraZeneca sanofi-aventis Pfizer Other projects Diabetes CVD L.Guénette Mental Health S.Lauzier Other projects on adherence Knowledge transfer J.-P.Grégoire
6 Purpose of the Chair Contribute to population health by proposing effective means to improve adherence. This goal will be achieved by means of: Research projects Knowledge transfer activities And also by increasing research capacity in the field of adherence
7 Acknowledgment
8 45 years of research on treatment adherence First article 1967 PubMed numbers for search strategy «Patient compliance AND drug therapy»
9 45 years of research on treatment adherence First article PubMed numbers for search strategy «Patient compliance AND drug therapy»
10 A definition the extend to which patient s behavior coincides with healthcare professional s advice
11 Taxonomy over the years Source: Vrijens et al., A new taxonomy for describing and defining adherence to medications
12
13 Pharmacy visit Initial acquisition of drug ACCEPTATION
14 Pharmacy visit Initial acquisition of drug Pharmacy visit Subsequent acquisitions of drug ACCEPTATION PERSISTENCE
15 All doses taken in accordance with healthcare professional recommendations Pharmacy visit Initial acquisition of drug Pharmacy visit Subsequent acquisitions of drug ACCEPTATION PERSISTENCE COMPLIANCE
16
17 Adherence
18 Adherence
19 Adherence Persistence Persistence
20 Adherence Compliance Persistence Persistence
21 Adherence Compliance Compliance Persistence Persistence
22 Magnitude of the problem Medications for chronic diseases First prescription not filled: ~30% Filled only once: ~20% Individuals persisting after 6 months: ~65% % covered at least 80% of the time: ~75%
23 Magnitude of the problem Suboptimal treatment outcomes DiMatteo et al., Med Care 2002 Higher healthcare costs and higher risk of hospitalization Sokol et al., Med Care 2005 Worldwide burden likely to increase WHO, 2003
24
25 Study Adults with type 2 diabetes in Quebec Design: Prospective cohort Source: RAMQ databases (pharmaceutical services) Population: New users of OAD (from 1/01/2000 to 31/12/2008)
26 Definitions Persistence A claim for any AD in the period (45 or 90 days) preceding the one-year anniversary of the first claim Compliance At least 80% of the days covered with any AD
27 Persistence -365 days OAD treatment start date 365 days (measure date) Presence of a prescribed anti-diabetic treatment in this period (45 or 90 days) Figure 1: Persistence measurement
28 Compliance MPR 80% -365 days OAD treatment start date Periods of hospitalization and overlaps with the prescriptions are excluded from the calculation. 365 days 30 days Measurement of the number of days covered by a prescription of an antidiabetes treatment among persistent individuals Figure 2: Compliance measurement
29 Results 38%
30 Is this an easy task for the patients?
31 Doses missed: ~16% 20% 11%
32 Why is it this way?
33 WHO s five dimensions of adherence Health-system related factors Socioeconomical factors Conditionrelated factors Therapyrelated factors Patient-related factors
34 Characteristics Age Persistence (n=119,832) Reference Compliance (n= 93,418) Reference Gender NR NR Region Urbain Rural Unavailable Characteristics associated with persistance and compliance with OAD treatment Socioeconomic status High Medium Low Reference - Reference Reference = Reference
35 Characteristics Specialty of initial prescriber Endocrinologist or internist GP Other or unknown Initial OAD Metformin Secretagogue Other Hospitalization No Yes Number of physician visits < Number of distinct drugs < Persistence (n=119,832) Reference - Reference - Reference NR Reference - - Reference Compliance (n= 93,418) Reference = Reference - Reference Reference - - Reference
36 Psychosocial determinants Beliefs Knowledge Motivation (I have the intention to take it as prescribed) Attitude (I am favorable, I see the advantages) Social norm (my family/friends approve or not) Perception of control (I can do it, I recognize the barriers)
37 Theoretical model Theory of planned behavior Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50,
38 Study Identification of salient beliefs Method: o 6 focus-groups of 6 to 8 participants (n = 45) osemi-structured interview guide with the following questions asked: advantages/disadvantages, people who agree/disagree, facilitating factors/barriers to OAD treatment Analysis: o Content analysis by 3 members of the research team o Beliefs most often mentioned were selected
39 Results Salient beliefs Beliefs Advantages/Disadvantages Frequency (%) Cumulative frequency (%) Avoid long-term complications Control glycemia It gives me gastrointestinal problems (diarrhea, gas, etc.) Feel good Feel less tired Not having to increase my medication Avoid transfering to insulin People who agree or disagree My spouse My children My family
40 Results Salient beliefs Facilitating factors Beliefs Frequency (%) Cumulative frequency (%) To have them always on me To keep an eye on them on the counter To have a routine To have somebody to remind me To use a pill dispenser Have a trick to help me remember Barriers When we are away, on vacation, or in a restaurant Not owning my disease and my medication Not having confidence in the physician s prescription When people come over
41 What can we do about this?
42 Interventions that we are developing COMMUNICATE PHARE
43 Intervention Mapping Step 1: Needs assessment Survey with patients with type 2 diabetes Focus groups with patients with type 2 diabetes Interviews with key informants Step 2: Matrices of change objectives Identification of changes targeted depending on step 1 results and literature review Step 3: Identification of appropriate methods Choice of theoretical methods that can influence changes in identified determinants and practical applications to implement them Step 4: Intervention production Creation of themes, sequence, and materials Programming Pretests and adjustments Step 5: Adoption and implementation Intervention s launch Adjustments
44 Thank You! Line Guénette Faculté de pharmacie de l Université Laval, Unité de recherche en santé des populations, CHA de Québec
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