PATIENTS’ ADHERENCE TO DISEASE-MODIFYING · PDF fileMean Score Best Acti viti es of...
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Poster Presented at the ISPOR 19th Annual International Meeting | May 31-June 4, 2014 | Montreal, QC, Canada © Copyright – 2014 Kantar Health GmbH, Landsberger Str. 284, 80687 Munich, Germany, Phone: +49 89 5600-1005 www.kantarhealth.com PATIENTS’ ADHERENCE TO DISEASE-MODIFYING THERAPIES (DMT) FOR MULTIPLE SCLEROSIS AND IMPACT ON QUALITY OF LIFE IN 22 COUNTRIES Mercedes Apecechea de Scheffer, MD; Susanne Faber, MSc; Peter Pohoff , PhD; Florian Eichmann, PhD Kantar Health GmbH, Munich, Germany OBJECTIVE • It is well-known that Mulple Sclerosis (MS) can disturb quality of life in different domains. Disease-modifying therapies (DMT) play an important part (Trisolini et al. 2010) in the treatment of MS and thus reducing Quality of Life (QoL) disturbances. Non-adherence to DMT affects therapy success and can thereby reduce posive treatment effects on Health Related Quality of Life (HRQoL). The present study invesgates paent adherence to approved DMTs for MS among geographically and culturally diverse paent populaons and their impact on HRQoL. Central Study Coordinaon Noficaon Local Help-Desk Site Mgmt. Direct Access for Local Kantar PM 1st Data Entry Query Processing Compleon of Queries Monthly Newsleers Provision of Weekly Newsleers Remuneraon of Invesgators 2nd Data Entry Provision of Status Reports Compleon of CRF/ Quesonnaire Sponsor Kantar Health Study Center Kantar Local Affiliates Invesgators/ Paents Direct Access for Sponsor Study Team InDrums: Web-based Project Mgmt. Applicaon (S)AE Processing (S)AE Screening Chart 1: Medical Site and Paent Recruitement Work Flow The recruitment procedure resulted in the enroll- ment of 2,566 paents within 6 months. Paent characteriscs are displayed in Table 1. More than 70% of the study populaon was female and mean age was approximately 40 years. Mean disease duraon was 6 years with a range of 0 to 56 years. PND35 Table 1: Structure of the Sample Overall N = 2,566 Age and Gender of Paents Age, Year Mean (+/- SD) 39.7 (10.1) % Female 73.1 n.a. 11 Relapses Within Last Year (% Paents) 0 59.7 1 26.5 2 9.4 > 3 4.4 Disease Duraon, Year Median (Range) 6.0 (0-56) Time on Current DMT, Mean Median (Range) 31.0 (6-192) RESULTS II – Musi Q o L PROFILE • Adherent paents had higher (=beer) scores than non-adherent paents on 7 of the 9 dimen- sions of the MusiQol (see Chart 3). Ranked by p-values adherent paents scored beer on physical well being, symptoms, relaonship with family, relaonship with healthcare system, senmental and sexual life, acvies of daily living, and relaonship with friends. For coping behavior and rejecons no differences could be observed. Chart 3: MusiQol – Adherent vs Non-adherent Paents Worst 0 20 40 60 80 100 Mean Score Best Acvies of Daily Living Physical Well Being Symptoms Relaonship with Friends Relaonship with Family Relaonship with Healthcare System Senmental and Sexual Life Coping Rejecons Adherent Non-adherent p < 0,05 p < 0,001 p < 0,01 p < 0,05 p < 0,001 p < 0,001 p < 0,01 p < n.s. p < n.s. Reference M. Trisolini, A. Honeycu, J. Wiener, S. Lesesne Global Economic Impact of Mulple Sclerosis. RTI Project Number: 0211748.000.001 Research Triangle Parc, 2010 METHODS Study type • The study was an observaonal mulnaonal post markeng study. Paents 18 years or older with a documented diagnosis of relapsing- reming MS (RRMS) and monotherapy with current DMT from Argenna, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Iran, Ireland, Israel, Italy, Mexico, the Netherlands, Portugal, Spain, Sweden, Switzerland, UK, and Venezuela were included. Documentaon • Data were collected via physicians’ documentaon of site characteriscs and paent variables: Site characteriscs: - Infrastructure - Role of nurse - Treatment paradigms - Training on disease and treatment Paent variables: - Disease history and current status - Treatment history - Degrees of impairment - Current therapy Addionally, paents filled in a comprehensive quesonnaire, including: - Personal and social items - Educaon on MS and DMTs - Views on medical management - Reasons for non-adherence - Complicaons Medical data and HRQoL • Retrospecve medical data about diagnosis and therapy were documented by physicians or nurses. For the purpose of paent reported outcome assessment, the MS Neuropsychological Screening Quesonnaire (MSQN) and the MS Internaonal Quality of Life Quesonnaire (MusiQoL) were selected. Site Recruitment • Sites were recruited from hospitals, office-based physicians and neurology competence centers. In total, 176 sites were included. Careful training was performed by face-to-face instrucons and use of a training video. Site management was supported by Kantar Health local affiliates, newsleers and a query process for quality assurance. - To meet ethical and legal requirements, the study was submied to health authories and IRBs/ECs as locally required. - Connuous site-management included: delivery of study documents, set-up and update of a central study database, using the InDrums-system for web based study management and data entry, web-based status reports to sponsor, weekly enrollment status delivery and sponsor, regular newsleer, local on-site support. - Further tasks of the central study operaon management team included: data management and data quality-control, safety monitoring, invesgator remuneraon. • A standardized workflow for recruing medical sites and MS paents for internaonal studies was used (see Chart 1). Chart 4: MSQN – Adherent vs Non-adherent Paents Adherent n = 301 Median Total Score 50 40 30 20 10 0 p < 0.001 Non-adherent n = 175 RESULTS I – ADHERENCE • “Adherence” was operaonally defined as: “Not missing a DMT injecon or changing dose within 4 weeks prior to study”. The study findings revealed that 75.0% of the paents were adherent. The most common reasons for non-adherence were forgeng to administer the injecon, being red of taking injecons, pain at injecon, and injecon anxiety. • Compared to non-adherent paents, the disease history of adherent paents showed shorter disease duraon (adherent: median 6 years; non- adherent: median 7 years), significantly shorter treatment me (30 months vs. 36 months; p<.001). Chart 2: Reasons for Non-adherence Forgot To Administer Tired Of Taking Injecons Other Fague Flu-Like Symptoms Pain At Injecon Site Headache Dosing Schedule Difficult/Inconvenient Injecon Anxiety Skin Reacon Weakness Depression Did Not Pick Up Medicine Did Not Feel Need For Injecon Nobody Available To Administer Financial Reasons Not Confident In Treatment Benefits Pregnancy/Planned Pregnancy Note: Paents could have reported more than one reason for non-adherence. 50% 20% 17% 13% 15% 12% 10% 10% 10% 9% 8% 6% 5% 4% 3% 2% 2% 1% RESULTS III – MSQN SCORES • The MSQN for the assessment of neuropsycho- logical funcon was only available in an English version. Adherent paents had a significantly beer MSQN score than non-adherent paents (see chart 4). Adherence to DMT seems thus to improve neuropsychological funconing. CONCLUSIONS • Non-adherence to DMTs tends to reduce posive effects of DMTs on QoL of MS paents. Effects can be observed for physical, neuropsychological, social and behavioral dimensions of HRQoL. For the improvement of adherence posive impacts on QoL can be expected. Special aenon should be given to the causes for non-adherence. Reminder systems for injecons e.g. can overcome the most frequent reason for non-adherence. RZ_Plakate_Montreal_260514_32pt.indd 1 26.05.14 21:36
Transcript of PATIENTS’ ADHERENCE TO DISEASE-MODIFYING · PDF fileMean Score Best Acti viti es of...
Poster Presented at the ISPOR 19th Annual International Meeting | May 31-June 4, 2014 | Montreal, QC, Canada© Copyright – 2014 Kantar Health GmbH, Landsberger Str. 284, 80687 Munich, Germany, Phone: +49 89 5600-1005
www.kantarhealth.com
PATIENTS’ ADHERENCE TO DISEASE-MODIFYING THERAPIES (DMT) FOR MULTIPLE SCLEROSIS AND IMPACT ON QUALITY OF LIFE IN 22 COUNTRIES
Mercedes Apecechea de Scheff er, MD; Susanne Faber, MSc; Peter Pott hoff , PhD; Florian Eichmann, PhDKantar Health GmbH, Munich, Germany
OBJECTIVE
• It is well-known that Multi ple Sclerosis (MS) can disturb quality of life in diff erent domains. Disease-modifying therapies (DMT) play an important part (Trisolini et al. 2010) in the treatment of MS and thus reducing Quality of Life (QoL) disturbances. Non-adherence to DMT aff ects therapy success and can thereby reduce positi ve treatment eff ects on Health Related Quality of Life (HRQoL). The present study investi gates pati ent adherence to approved DMTs for MS among geographically and culturally diverse pati ent populati ons and their impact on HRQoL.
Central Study Coordinati on
Noti fi cati on
Local Help-Desk Site Mgmt.
Direct Access
for Local Kantar PM
1st Data Entry
Query Processing
Completi on of Queries
Monthly Newslett ers
Provision of Weekly
Newslett ers
Remunerati on of
Investi gators2nd Data
Entry
Provision of Status Reports
Completi on of CRF/
Questi onnaire
Sponsor Kantar Health Study Center
Kantar Local Affi liates
Investi gators/ Pati ents
Direct Access
for Sponsor Study Team
InDrums:Web-based
Project Mgmt.
Applicati on
(S)AE Processing
(S)AE Screening
Chart 1: Medical Site and Pati ent Recruitement Work Flow
The recruitment procedure resulted in the enroll-ment of 2,566 pati ents within 6 months. Pati ent characteristi cs are displayed in Table 1. More than 70% of the study populati on was female and mean age was approximately 40 years. Mean disease durati on was 6 years with a range of 0 to 56 years.
PND35
Table 1: Structure of the Sample
OverallN = 2,566
Age and Gender of Pati ents
Age, Year Mean (+/- SD) 39.7 (10.1)
% Female 73.1
n.a. 11
Relapses Within Last Year (% Pati ents)
0 59.7
1 26.5
2 9.4
> 3 4.4
Disease Durati on, Year Median (Range) 6.0 (0-56)
Time on Current DMT, Mean Median (Range)
31.0 (6-192)
RESULTS II – MusiQoL PROFILE
• Adherent pati ents had higher (=bett er) scores than non-adherent pati ents on 7 of the 9 dimen-sions of the MusiQol (see Chart 3). Ranked by p-values adherent pati ents scored bett er on physical well being, symptoms, relati onship with family, relati onship with healthcare system, senti mental and sexual life, acti viti es of daily living, and relati onship with friends. For coping behavior and rejecti ons no diff erences could be observed.
Chart 3: MusiQol – Adherent vs Non-adherent Pati ents
Worst0 20 40 60 80 100
Mean Score Best
Acti viti es of Daily Living
Physical Well Being
Symptoms
Relati onship with Friends
Relati onship with Family
Relati onship with Healthcare System
Senti mental and Sexual Life
Coping
Rejecti ons
Adherent Non-adherent
p < 0,05
p < 0,001
p < 0,01
p < 0,05
p < 0,001
p < 0,001
p < 0,01
p < n.s.
p < n.s.
ReferenceM. Trisolini, A. Honeycutt , J. Wiener, S. Lesesne
Global Economic Impact of Multi ple Sclerosis.
RTI Project Number: 0211748.000.001 Research Triangle Parc, 2010
METHODS
Study type• The study was an observati onal multi nati onal
post marketi ng study. Pati ents 18 years or older with a documented diagnosis of relapsing-remitti ng MS (RRMS) and monotherapy with current DMT from Argenti na, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Iran, Ireland, Israel, Italy, Mexico, the Netherlands, Portugal, Spain, Sweden, Switzerland, UK, and Venezuela were included.
Documentati on• Data were collected via physicians’
documentati on of site characteristi cs and pati ent variables:
Site characteristi cs:- Infrastructure- Role of nurse- Treatment paradigms- Training on disease and treatment
Pati ent variables: - Disease history and current status
- Treatment history- Degrees of impairment- Current therapy
Additi onally, pati ents fi lled in a comprehensive questi onnaire, including:- Personal and social items- Educati on on MS and DMTs- Views on medical management- Reasons for non-adherence- Complicati ons
Medical data and HRQoL• Retrospecti ve medical data about diagnosis
and therapy were documented by physicians or nurses. For the purpose of pati ent reported outcome assessment, the MS Neuropsychological Screening Questi onnaire (MSQN) and the MS Internati onal Quality of Life Questi onnaire (MusiQoL) were selected.
Site Recruitment• Sites were recruited from hospitals, offi ce-based
physicians and neurology competence centers. In total, 176 sites were included.Careful training was performed by face-to-face instructi ons and use of a training video. Site management was supported by Kantar Health local affi liates, newslett ers and a query process for quality assurance.
- To meet ethical and legal requirements, the study was submitt ed to health authoriti es and IRBs/ECs as locally required.
- Conti nuous site-management included: delivery of study documents, set-up and update of a central study database, using the InDrums-system for web based study management and data entry, web-based status reports to sponsor, weekly enrollment status delivery and sponsor, regular newslett er, local on-site support.
- Further tasks of the central study operati on management team included: data management and data quality-control, safety monitoring, investi gator remunerati on.
• A standardized workfl ow for recruiti ng medical sites and MS pati ents for internati onal studies was used (see Chart 1).
Chart 4: MSQN – Adherent vs Non-adherent Pati ents
Adherentn = 301
Med
ian
Tota
l Sco
re
50
40
30
20
10
0
p < 0.001
Non-adherentn = 175
RESULTS I – ADHERENCE
• “Adherence” was operati onally defi ned as: “Not missing a DMT injecti on or changing dose within 4 weeks prior to study”. The study fi ndings revealed that 75.0% of the pati ents were adherent. The most common reasons for non-adherence were forgetti ng to administer the injecti on, being ti red of taking injecti ons, pain at injecti on, and injecti on anxiety.
• Compared to non-adherent pati ents, the disease history of adherent pati ents showed shorter disease durati on (adherent: median 6 years; non-adherent: median 7 years), signifi cantly shorter treatment ti me (30 months vs. 36 months; p<.001).
Chart 2: Reasons for Non-adherence
Forgot To Administer
Tired Of Taking Injecti ons
Other
Fati gue
Flu-Like Symptoms
Pain At Injecti on Site
Headache
Dosing Schedule Diffi cult/Inconvenient
Injecti on Anxiety
Skin Reacti on
Weakness
Depression
Did Not Pick Up Medicine
Did Not Feel Need For Injecti on
Nobody Available To Administer
Financial Reasons
Not Confi dent In Treatment Benefi ts
Pregnancy/Planned Pregnancy
Note: Pati ents could have reported more than one reason for non-adherence.
50%
20%
17%
13%
15%
12%
10%
10%
10%
9%
8%
6%
5%
4%
3%
2%
2%
1%
RESULTS III – MSQN SCORES
• The MSQN for the assessment of neuropsycho-logical functi on was only available in an English version. Adherent pati ents had a signifi cantly bett er MSQN score than non-adherent pati ents (see chart 4). Adherence to DMT seems thus to improve neuropsychological functi oning.
CONCLUSIONS
• Non-adherence to DMTs tends to reduce positi ve eff ects of DMTs on QoL of MS pati ents. Eff ects can be observed for physical, neuropsychological, social and behavioral dimensions of HRQoL. For the improvement of adherence positi ve impacts on QoL can be expected. Special att enti on should be given to the causes for non-adherence. Reminder systems for injecti ons e.g. can overcome the most frequent reason for non-adherence.
RZ_Plakate_Montreal_260514_32pt.indd 1 26.05.14 21:36
