Download A REVIEW OF PATIENT REGISTRIES IN HEART FAILURE

A REVIEW OF
PATIENT
REGISTRIES IN
HEART FAILURE
ACROSS EU-5
COUNTRIES
Jatin Gupta, Manu Sehgal, Palvi Gupta
PAREXEL
9th November 2015
CONFIDENTIAL
© 2015 PAREXEL INTERNATIONAL CORP.
AGENDA
A REVIEW OF
PATIENT
REGISTRIES IN
HEART FAILURE
ACROSS EU-5
COUNTRIES
© 2015 PAREXEL INTERNATIONAL CORP. / 2
• Background and objective
• Approach and methodology
• Results
• Conclusion and limitations
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BERLIN, GERMANY
BACKGROUND AND
OBJECTIVES
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BACKGROUND
HEART FAILURE
BURDEN OF HF
REGISTRIES
• Heart failure (HF*) is a
complex clinical syndrome
of symptoms and signs that
suggest the efficiency of the
heart as a pump is impaired.
It is caused by structural or
functional abnormalities of
the heart (NICE CG108)
• HF is a global public health
problem affecting an
estimated 26 million
worldwide (Ambrosy 2014).
The prevalence of HF in
Europe is ~1-2% (France
2.2%, UK 1.3%) (Cowie 2015)
• Registries are prospective,
observational cohort studies
of patients who have a
particular disease and/or are
receiving a particular
treatment or intervention. It
involves prospective data
collection of clinical,
economic, and PRO*
information that rely on realtime data capture (Garrison
2007)
• HF is a chronic condition
predominantly affecting
people over the age of
50 years and its incidence
and prevalence increases
with age (NICE TA314)
• Acute HF is complex clinical
syndrome characterized by a
rapid change in the signs
and symptoms of HF,
resulting in a need for
urgent therapy, and is often
life-threatening (Dahlstrom
2010)
• Chronic HF is associated
with high mortality and
morbidity rate, decreased
quality of life, and rising
healthcare costs in Europe
and globally (Dahlstrom
2010)
• HF accounts for 1-3% of all
US and European hospital
admissions (Cowie 2015)
• Almost 25% hospitalised
patients are re-hospitalised
for HF within the 30- day
post discharge period,
respectively (O’Connor 2010)
*HF: Heart Failure; PRO: Patient Reported Outcomes
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• Patient registries are a good
source of evidence for
clinicians, disease
organizations, health
technology agencies, health
insurers/payers, regulatory
authorities requiring realworld data for evidencebased decision making
(Garrison 2007)
RATIONALE FOR THIS REVIEW
RCTs* are regarded as the gold standard for clinical decision making purposes.
However, data from RCTs often have limited external validity (generalisability) for the
following reasons:
•
Highly selected patient populations
•
Often limited to specific geographic settings
•
Most data pertain to hospitalised patients
•
Registries and surveys in patients with acute and chronic HF* can provide a
longitudinal view of the whole clinical story of patients with HF including the acute
episodes and the consequent changes in the clinical conditions and in the
management strategies
•
Many registries with real-world data on HF patients exist but a comprehensive
review to help understand the scope, availability, and quality of collected data is
currently lacking
The objective of this review was to systematically identify and assess
key characteristics of HF registries reporting patients’ data across the
EU-5 countries
*HF: Heart Failure; RCTs: Randomised Controlled Trials
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APPROACH AND
METHODOLOGY
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HF REGISTRIES WERE IDENTIFIED THROUGH A
SYSTEMATIC REVIEW OF THE PUBLISHED LITERATURE
AND INTERNET SEARCH
Searching of databases
• HF* registries were identified through a systematic search of
Embase® and MEDLINE® databases using embase.com interface
Key inclusion criteria
• Registries with data on HF patients from EU5* countries (France,
Germany, Italy, Spain, and the UK*) and patient counts ≥1000 were
included
Analysing evidence from registry websites/publications
• Registry website and publications in peer-reviewed journals were
assessed for availability of information on basic registry details,
patient characteristics, disease management, resource use, and
treatment outcomes
*EU5: European Union Countries; HF: Heart Failure; UK: United Kingdom
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FOLLOWING DATA VARIABLES WERE SOUGHT FOR
EACH IDENTIFIED REGISTRY
Category
Data variables
Basic registry information
Region, acronym, full name, website, country,
year established and data collection period,
current status (active or inactive), patient group,
objective, funding agency
Patient characteristics
Age, gender, race/ethnicity, comorbidities
Disease management
Diagnosis and staging of HF*, diagnostic
procedures and tests, treatment procedures,
pharmacological interventions
Resource use
Hospitalisations, ER* visits, outpatient visits,
primary care visits, length of stay, cost
Treatment outcomes
Laboratory results, quality of life
(scale/instrument used), adverse events
reported, survival data/all-cause/HF-specific
mortality rates
*ER: Emergency Room; HF: Heart Failure
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RESULTS
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REVIEW IDENTIFIED 23 REGISTRIES WITH >1000
PATIENTS
Number of included patients varied from 1037 to 25,000 with the average follow-up
ranging from 3-53 months
No. of HF
patients
Name
Acronym
Acute Heart Failure Global Registry of Standard Treatment
Clinical Practice Research Datalink
Disease management program in heart failure in Lorraine (Insuffisance
Cardiaque en Lorraine)
Epidemiology of Acute Heart Failure in Emergency Registry
EuroHeart Failure Survey I
EuroHeart Failure Survey II
European Society of Cardiology-Heart Failure Long-Term Registry
European Society of Cardiology-Heart Failure Pilot Survey
Evidence based Treatment in Heart Failure registry
German Competence Network Heart Failure database
Global Registry of Acute Coronary Events
Global Registry of Acute Coronary Events 2
HELUMA heart failure registry
Italian Network on Heart Failure Outcome registry
Italian Survey on Acute Heart Failure
Realise Atrial Fibrillation Registry
Schlahf registry
ScreenIng of todays patIents with Chronic systolic heart failure
Spanish National Registry on Heart Failure
Spanish REDINSCOR registry (Clinical and Preclinical Heart Failure Research
Network Registry)
The prospective observational Longitudinal RegIstry of patients with stable
coronary artery disease
Trieste Registry of CV Diseases
VIDA-IC study
ALARM-HF
CPRD
ICALOR
4,953
8,404
25,000
EAHFE-1,2,3
EHFS I
EHFS II
ESC Heart Failure
ESC-HF Pilot
EVITA-HF
CNHF
GRACE
GRACE 2
HELUMA
IN-HF
IS-AHF
RealiseAF
SchlaHF
INDICATE
RICA
REDINSCOR
5,845
10,701
3,580
19,211
5,118
3,082
12,756
>5,000
>5,000
2,318
5,610
2,807
4,790
8,341
15,148
>4,000
2,263
CLARIFY
4,943
VIDA-IC
2,217
1,037
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MULTIPLE HF REGISTRIES EXIST FOR EACH EU-5
COUNTRY
•
A total of 43% registries were multinational while 57% were local or nationally representative
patient registries
•
Data was collected for patients with acute HF* only (31%), chronic HF only (43%), and both
acute and chronic HF (26%) in the identified registries
•
Twelve registries each collected data from Spain, Germany, and Italy and eight and six
registries from France and the UK*, respectively
60%
Percentages of registries
50%
40%
30%
57%
52%
20%
43%
43%
34%
31%
26%
26%
10%
0%
Multinational
National
Setting
Spain, Germany,
and italy
France
Countries
*HF: Heart Failure; UK: United Kingdom
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UK
Acute HF
Chronic HF
Patient type
Both acute and
chronic HF
MAJORITY OF THE REGISTRIES REPORTED DATA FOR
PATIENT DEMOGRAPHICS, CLINICAL CHARACTERISTICS,
MANAGEMENT, AND OUTCOMES
Data was available for patient demographics (100%), comorbidities (87%), diagnosis and disease
classification (78%), mortality (78%), hospitalisation (96%), prescribed drugs (100%), and patient-reported
outcomes (17%)
Percentages of registries reporting data
120%
100%
80%
60%
100%
100%
87%
40%
78%
96%
78%
20%
17%
0%
Demographics
Comorbidities
Diagnosis and
disease
classification
Mortality
Prescribed
drugs
Hospitalisation
PRO
It appears from the published data that there is less emphasis on patient reported outcomes
PRO: Patient Reported Outcomes
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Specific treatment
procedures
Specific diagnostic
procedures and test results
REGISTRIES REPORTED DATA FOR SPECIFIC
DIAGNOSTIC PROCEDURES, TREATMENT, AND
RESOURCE USE
Blood pressure
91%
Blood tests
87%
Renal function
70%
Imaging (Echo)
70%
Electrocardiogram
65%
Biomarkers (NT-proBNP, BNP)
44%
Coronary revascularisation
57%
Cardiac rhythm device
52%
Heart catheterization
39%
Heart transplant
13%
Electrophysiology mapping
9%
Resource use
Hospitalisations
96%
Length of stay
57%
Outpatient visit
39%
Emergency room visit
22%
Cost PRO AE
Primary care visit
13%
Any AE or specific AE
17%
Patient reported outcomes
17%
Direct or indirect
13%
0%
10%
20%
30%
40%
50%
60%
70%
80%
AE: Adverse Event; BNP: Brain Natriuretic Peptide; NT-proBNP: N-terminal pro-brain natriuretic peptide
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90%
100%
OVER THE LAST DECADE THERE HAS BEEN A SHARP
INCREASE IN THE NUMBER OF HF REGISTRIES
6
CLARIFY
ESC-HF Pilot
EVITA-HF
Realise AF
Trieste Registry
Number of registries
5
EAHFE
IN-HF
SchlaHF
REDINSCOR
4
3
GRACE
GRACE 2
EHFS II
IS-AHF
VIDA-IC
ESC Heart Failure
ALARM-HF
ICALOR
2
HELUMA
INDICATE
1
CPRD
0
1985
EHFS I
1990
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1995
2000
Inception year
CONFIDENTIAL
CNHF
RICA
2005
2010
2015
OVER THE LAST DECADE THERE HAS BEEN A SHARP
INCREASE IN THE NUMBER OF HF REGISTRIES
15 out of 23 registries initiated post-2005
6
CLARIFY
ESC-HF Pilot
EVITA-HF
Realise AF
Trieste Registry
Number of registries
5
EAHFE
IN-HF
SchlaHF
REDINSCOR
4
3
GRACE
GRACE 2
EHFS II
IS-AHF
VIDA-IC
ESC Heart Failure
ALARM-HF
ICALOR
2
HELUMA
INDICATE
1
CPRD
0
1985
EHFS I
1990
1995
2000
Inception year
CNHF
RICA
2005
2010
2015
Note: Text in red font indicates registries supported by industry-funding; Black text indicates registries supported by non-profit organizations /universities/ government
agencies or where funding information was not clear
Inception year for 15 out of 23 registries was post-2005 i.e. majority of the registries
initiated in last 10 years reflecting increase in use of real-world data in the recent years
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MAJORITY OF REGISTRIES WERE SPONSORED BY
INDUSTRIES
Majority of published registries were sponsored by pharmaceutical companies (61%); while
30% of registries were sponsored by non-profit organisations, universities or government
agencies
Not
specified
9%
Other
30%
Industry
funded
61%
Rise in the number of heart failure registries in recent years and industry funding indicates
increased interest of stakeholders in these registries’ data
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BASED ON DATA VARIABLES REPORTED, TWO
REGISTRIES PROVIDED MOST COMPREHENSIVE VIEW
OF THE HF PATIENTS IN REAL-WORLD SETTINGS
•
Identified HF registries were assessed for percentage availability of information on the key data
variables
14
Number of registries
12
10
8
6
12
4
8
2
0
2
1
≤25%
26-50%
51-75%
>75%
Percentage availability of data on key variables
A total of 63% registries reported data on >50% of the assessed data variables
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CONCLUSION
AND LIMITATIONS
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CONCLUSION
•
Rise in the number of HF* registries and industry funding in recent years indicate
increased interest of stakeholders in these registries’ data
•
Majority of the registries collected data on key clinical outcomes like hospitalisations
and mortality in HF patients demonstrating concordance with the clinical studies
•
However, only a few registries collected data on the use of biomarkers (NTpro-BNP*,
BNP*, troponin), treatment procedures, patient-reported outcomes, adverse events,
and costs of care
•
Long-term follow-up data from registries could help to identify the prognostic factors
predisposing HF patients to rehospitalization and sudden death and to understand
the impact of interventions on patients’ quality of life, thus, complementing the
clinical efficacy demonstrated in relatively short-term, controlled clinical trials
•
Further, applicability and acceptance of HF registries’ data to inform access and
reimbursement decisions and to determine cost-effectiveness of different
interventions in clinical practice need to be evaluated
* BNP: B-type natriuretic peptide; HF: Heart Failure; NTpro-BNP:N-terminal pro-brain natriuretic peptide
© 2015 PAREXEL INTERNATIONAL CORP. / 19
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LIMITATIONS OF THE REVIEW
•
All literature reviews are limited by publication bias with respect to the available
articles. Also, only English language articles were considered for this review
•
This review was limited to registries with more than 1000 patients and at least
one of the data collection center in EU-5 countries
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REFERENCES
NICE CG108 (2010) Management of chronic heart failure in adults in primary and secondary care.
Available at: http://www.nice.org.uk/guidance/cg108/resources/guidance-chronic-heart-failure-pdf
NICE TA314 (2014) Implantable cardioverter defibrillators and cardiac resynchronisation therapy for
arrhythmias and heart failure. Available at: https://www.nice.org.uk/guidance/ta314
Dahlstrom U et al. (2010) Heart Failure Pilot Protocol. CardioPulse Article. European Heart Journal.
31:2184-2186
Ambrosy AP et al. (2014) The global health and economic burden of hospitalizations for heart failure: :
lessons learned from hospitalized heart failure registries. Journal of the American College of
Cardiology. 63 (12):1123-1133
Cowie MR (2015). The global burden of heart failure. European Society of cardiology presentation
Garrison LP et al. (2007). Using real-world data for coverage and payment decisions: The ISPOR
real-world data task force report. Value in Health. 10 (5):326-335
O’Connor CM et al. (2010) Causes of death and rehospitalization in patients hospitalized with
worsening heart failure and reduced left ventricular ejection fraction: results from Efficacy of
Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) program.
American Heart Journal. 159 (5):841-849
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QUESTIONS?
Jatin Gupta
Senior Consultant, Evidence
Evaluation
PAREXEL International
[email protected]
www.PAREXEL.com
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THANK YOU
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