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Supported by an unrestricted educational grant fromSupported by an unrestricted educational grant fromsanofi-aventis and by the ALS Association. sanofi-aventis and by the ALS Association.
Endorsed by the World Federation of NeurologyEndorsed by the World Federation of Neurology
AAmyotrophic myotrophic LLateral ateral SSclerosisclerosisCClinical linical AAssessment, ssessment, RResearch and esearch and EEducationducation
&&
The ALS Patient Care DatabaseThe ALS Patient Care Database
www.alscare.orgwww.alscare.org
2ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
ALS C.A.R.E. ProgramALS C.A.R.E. Program
ALS Patient Care ALS Patient Care DatabaseDatabase
Improved Improved outcomesoutcomes
Educational Educational programsprograms
OutcomesOutcomes EducationEducation
3ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
OverviewOverview
Voluntary, confidential, outcomes databaseVoluntary, confidential, outcomes database
Mechanism for evaluating the impact of diagnostic Mechanism for evaluating the impact of diagnostic and therapeutic decisionsand therapeutic decisions
Foundation for assessing current patterns Foundation for assessing current patterns of clinical practice of clinical practice
Effort to improve outcomes for patients with Effort to improve outcomes for patients with ALS and their caregiversALS and their caregivers
4ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
ObjectivesObjectives
Develop benchmarksDevelop benchmarks Provide individual and aggregate Provide individual and aggregate
data to neurologistsdata to neurologists Publish overall findings on issues such as Publish overall findings on issues such as
compliance with AAN practice parameterscompliance with AAN practice parameters Improve outcomesImprove outcomes
5ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Design PrinciplesDesign Principles
Observational cohort studyObservational cohort study Physician-, patient-, and caregiver-reported dataPhysician-, patient-, and caregiver-reported data Standard data collection instrumentsStandard data collection instruments Broad participationBroad participation Uniform diagnostic and assessment measuresUniform diagnostic and assessment measures Data collected at each routine patient visitData collected at each routine patient visit Quarterly reports delivered to participating Quarterly reports delivered to participating
neurologistsneurologists
6ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
ALS C.A.R.E. ProgramALS C.A.R.E. ProgramMedical Advisory BoardMedical Advisory Board
Robert G. MillerRobert G. Miller
Fred AndersonFred Anderson
Linda Boynton de SepulvedaLinda Boynton de Sepulveda
Mark B. BrombergMark B. Bromberg
Benjamin Rix BrooksBenjamin Rix Brooks
Michael GravesMichael Graves
Yadalloh HaratiYadalloh Harati
Terry Heiman-PattersonTerry Heiman-Patterson
Sharon MatlandSharon MatlandHiroshi MitsumotoHiroshi MitsumotoDan H. MooreDan H. MooreEric PioroEric PioroSteven P. RingelSteven P. RingelJeffrey RosenfeldJeffrey RosenfeldMark A. RossMark A. RossRobert L. SufitRobert L. SufitAshok VermaAshok Verma
November 2007
7ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Study Coordinating CenterStudy Coordinating Center
Center for Outcomes Research - University of Center for Outcomes Research - University of
Massachusetts Medical SchoolMassachusetts Medical School
Prepare quarterly reportsPrepare quarterly reports
Provide scientific support for data analysisProvide scientific support for data analysis
Assure confidentialityAssure confidentiality
8ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Physician ConfidentialityPhysician Confidentiality
Use of coded physician and clinic Use of coded physician and clinic
ID numbersID numbers
Physician names kept in locked filePhysician names kept in locked file
Provisions approved by UMass Medical Provisions approved by UMass Medical School’s IRBSchool’s IRB
Expedited local IRB approval (typical)Expedited local IRB approval (typical)
9ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Patient and Caregiver Patient and Caregiver ConfidentialityConfidentiality
Sites allocate patient ID numbersSites allocate patient ID numbers
Provisions approved by UMass Medical Provisions approved by UMass Medical
School’s IRBSchool’s IRB
Verbal informed patient consent per local Verbal informed patient consent per local
IRB (typical)IRB (typical)
10ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Data Collection InstrumentsData Collection Instruments
Health Professional FormHealth Professional Form
Patient FormPatient Form
Caregiver FormCaregiver Form
Completion FormCompletion Form
11ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Physician-Reported DataPhysician-Reported Data
Type of ALSType of ALS El Escorial diagnostic criteriaEl Escorial diagnostic criteria Atypical featuresAtypical features Regions affectedRegions affected ALS functional rating scoreALS functional rating score Forced vital capacityForced vital capacity ALS-related conditionsALS-related conditions Current managementCurrent management
12ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Patient Self-Reported DataPatient Self-Reported Data
Demographics (age, sex, etc)Demographics (age, sex, etc) Personal information (insurance, income, Personal information (insurance, income,
employment status, etc)employment status, etc) General health status (capacity to perform ADL, General health status (capacity to perform ADL,
psychosocial status, etc)psychosocial status, etc) Diagnostic factors (presenting symptoms)Diagnostic factors (presenting symptoms) Activities of daily livingActivities of daily living Use of services (number of physician visits, Use of services (number of physician visits,
satisfaction with medical care, etc)satisfaction with medical care, etc)
13ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Caregiver-Reported DataCaregiver-Reported Data
Relationship to patientRelationship to patient
Source of payment (if paid caregiver)Source of payment (if paid caregiver)
General health status of caregiverGeneral health status of caregiver
Psychosocial impact on caregiverPsychosocial impact on caregiver
Employment status of caregiverEmployment status of caregiver
14ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Quarterly ReportsQuarterly Reports
ConfidentialConfidential
Include individual physician/site and Include individual physician/site and
aggregate North American dataaggregate North American data
Allow participants to compare their Allow participants to compare their
outcomes with North American outcomes with North American
benchmarksbenchmarks
15ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
History of History of ALS C.A.R.E. ProgramALS C.A.R.E. Program
First board meetingFirst board meeting November 1995November 1995
Pilot trialPilot trial December 1995December 1995
Modify data formsModify data forms January 1996January 1996
Begin data collectionBegin data collection September 1996September 1996
First reportFirst report February 1997February 1997
>5,000 patients>5,000 patients February 2003February 2003
New report designNew report design February 2003February 2003
New report designNew report design February 2003February 2003
Electronic data captureElectronic data capture September 2004September 2004
>6,000 patients>6,000 patients November 2005November 2005
Data collection completedData collection completed June 2007June 2007
November 2007
16ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Enrollment SummaryEnrollment Summary
Clinics enrolledClinics enrolled 323 323
Clinics submitting dataClinics submitting data 109 109
Neurologists enrolledNeurologists enrolled 381 381
Patients enrolledPatients enrolled 6337 6337
November 2007
17ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Distribution of Enrolled SitesDistribution of Enrolled Sites
November 2007
18ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
Follow-Up DataFollow-Up Data
56805291
4327
2589 2556 2369
1731 1643 1449
0
1000
2000
3000
4000
5000
6000
7000
Health Professional Patient Caregiver
Nu
mb
er o
f F
orm
s
Enrolled 6-month follow-up 12-month follow-up
November 2007
19ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
DemographicsDemographicsAt Study EnrollmentAt Study Enrollment
Age, yearsAge, years
– MedianMedian 6060
– RangeRange 20-9020-90
CaucasianCaucasian 92%92%
FemaleFemale 41% 41%
November 2007
20ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
94%
6%
Sporadic Familial
Type of ALSType of ALS At Study EnrollmentAt Study Enrollment
November 2007
21ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
LimitationsLimitations
Observational, no control groupObservational, no control group
Mainly academic practicesMainly academic practices
No data on pathological confirmationNo data on pathological confirmation
More longitudinal data neededMore longitudinal data needed
22ROGRAMROGRAMTheThe
ALS CALS C..AA..RR..E PE P
ConclusionsConclusions
A North American database has been A North American database has been
established for studying ALSestablished for studying ALS
The database is informative about practice The database is informative about practice
patterns (diagnostic tests, treatment, etc.)patterns (diagnostic tests, treatment, etc.)
Patient satisfaction and patient needs are Patient satisfaction and patient needs are
reflected in the databasereflected in the database