Amyotrophic Lateral Sclerosis Clinical Assessment, Research and Education

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Amyotrophic Lateral SclerosisClinical
Assessment, Research and EducationThe ALS
Patient Care Databasewww.alscare.org
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ALS C.A.R.E. Program

• ALS Patient Care Database

Improved outcomes
Educational programs
Outcomes
Education
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Overview

• Voluntary, confidential, outcomes database
• Mechanism for evaluating the impact of diagnostic
  and therapeutic decisions
• Foundation for assessing current patterns
  of clinical practice
• Effort to improve outcomes for patients with ALS
  and their caregivers

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Objectives

• Develop benchmarks
• Provide individual and aggregate data to
  neurologists
• Publish overall findings on issues such as
  compliance with AAN practice parameters
• Improve outcomes

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Design Principles

• Observational cohort study
• Physician-, patient-, and caregiver-reported data
• Standard data collection instruments
• Broad participation
• Uniform diagnostic and assessment measures
• Data collected at each routine patient visit
• Quarterly reports delivered to participating
  neurologists

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ALS C.A.R.E. ProgramMedical Advisory Board

• Robert G. Miller
• Fred Anderson
• Linda Boynton de Sepulveda
• Mark B. Bromberg
• Benjamin Rix Brooks
• Michael Graves
• Yadalloh Harati
• Terry Heiman-Patterson

• Sharon Matland
• Hiroshi Mitsumoto
• Dan H. Moore
• Eric Pioro
• Steven P. Ringel
• Jeffrey Rosenfeld
• Mark A. Ross
• Robert L. Sufit
• Ashok Verma

November 2007
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Study Coordinating Center

• Center for Outcomes Research - University of
  Massachusetts Medical School
• Prepare quarterly reports
• Provide scientific support for data analysis
• Assure confidentiality

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Physician Confidentiality

• Use of coded physician and clinic
• ID numbers
• Physician names kept in locked file
• Provisions approved by UMass Medical Schools
  IRB
• Expedited local IRB approval (typical)

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Patient and Caregiver Confidentiality

• Sites allocate patient ID numbers
• Provisions approved by UMass Medical Schools
  IRB
• Verbal informed patient consent per local IRB
  (typical)

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Data Collection Instruments

• Health Professional Form
• Patient Form
• Caregiver Form
• Completion Form

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Physician-Reported Data

• Type of ALS
• El Escorial diagnostic criteria
• Atypical features
• Regions affected
• ALS functional rating score
• Forced vital capacity
• ALS-related conditions
• Current management

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Patient Self-Reported Data

• Demographics (age, sex, etc)
• Personal information (insurance, income,
  employment status, etc)
• General health status (capacity to perform ADL,
  psychosocial status, etc)
• Diagnostic factors (presenting symptoms)
• Activities of daily living
• Use of services (number of physician visits,
  satisfaction with medical care, etc)

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Caregiver-Reported Data

• Relationship to patient
• Source of payment (if paid caregiver)
• General health status of caregiver
• Psychosocial impact on caregiver
• Employment status of caregiver

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Quarterly Reports

• Confidential
• Include individual physician/site and aggregate
  North American data
• Allow participants to compare their outcomes with
  North American benchmarks

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History of ALS C.A.R.E. Program

• First board meeting November 1995
• Pilot trial December 1995
• Modify data forms January 1996
• Begin data collection September 1996
• First report February 1997
• gt5,000 patients February 2003
• New report design February 2003
• New report design February 2003
• Electronic data capture September 2004
• gt6,000 patients November 2005
• Data collection completed June 2007

November 2007
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Enrollment Summary

• Clinics enrolled 323
• Clinics submitting data 109
• Neurologists enrolled 381
• Patients enrolled 6337

November 2007
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Distribution of Enrolled Sites
November 2007
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Follow-Up Data
November 2007
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DemographicsAt Study Enrollment

• Age, years
• Median 60
• Range 20-90
• Caucasian 92
• Female 41

November 2007
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Type of ALS At Study Enrollment
November 2007
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Limitations

• Observational, no control group
• Mainly academic practices
• No data on pathological confirmation
• More longitudinal data needed

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Conclusions

• A North American database has been established
  for studying ALS
• The database is informative about practice
  patterns (diagnostic tests, treatment, etc.)
• Patient satisfaction and patient needs are
  reflected in the database