James Gordon, EdD, PT, FAPTA

1
Patient Perspectives and Quality of Life Early
PTClinResNet Outcomes

• James Gordon, EdD, PT, FAPTA
• Co-Principal Investigator, PTClinResNet
• Chair, Department of Biokinesiology Physical
  Therapy, University of Southern California

Combined Sections Meeting, San Diego, CA,
February 2, 2006
2
What is PTClinResNet?

• A clinical research network (CRN) to evaluate the
  efficacy of physical therapy interventions
• Established by PT researchers at USC and
  elsewhere (Jan, 2003)
• Funded by Foundation for PT (1.5 million) and
  member institutions (almost 1 million)
• Four separate randomized clinical trials (RCTs)
• Subject recruitment and baseline data collection
  completed by end of 2005
• Common aim of all four RCTs
• to determine whether exercise interventions can
  have a meaningful impact on patients quality of
  life

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Purpose of this Symposium

• To present baseline outcome measures in four
  clinical trials
• To classify various outcome measures within ICF
  framework
• To analyze relationships among outcome measures
  within and across ICF domains
• To discuss relationships of these measures to
  subjective quality of life

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Purpose of My Presentation

• To provide a broad overview of PTClinResNet
• To review ICF framework

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Overview of PTClinResNet

• Three aims
• Clinical research to evaluate efficacy of
  practice
• Build the infrastructure to support clinical
  trials research
• Education and training (knowledge transfer)
• Overall Goal
• To identify and test strategies for improving
  function and reducing disability using exercise
  interventions designed to enhance muscle
  performance through dynamic task-oriented or
  muscle-oriented approaches

6
Four Randomized Controlled Trials

• STEPS Strength-training effectiveness post
  stroke
• David Brown, Ph.D., P.T., Lead I
• MUSSEL Muscle specific strengthening
  effectiveness post lumbar microdiscectomy
• Kornelia Kulig, Ph.D., P.T., Lead I
• PEDALS Pediatric endurance development and limb
  strengthening
• Eileen Fowler, Ph.D., P.T., Lead I
• STOMPS Strengthening and optimal movements for
  painful shoulders in chronic spinal cord injury
• Bryan Kemp, Ph.D., Lead I

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University of Southern California Department of
Biokinesiology and Physical Therapy Coordinating
Center
Scientific Advisory Panel
Data Monitoring and Safety Committee
Network Sites
Randomized Clinical Trials Projects
University of Southern California
STEPS (CVA) Phase II/III
Rancho Los Amigos National Rehabilitation Center
Northwestern University
PEDALS (CP) Phase II
University of California, Los Angeles
Central Data Management and Analysis
MUSSEL (Spine) Phase II
Orthopaedic Hospital 7 pediatric practices in
LA MO
Missouri State University
STOMPS (SCI) Phase I
17 Outpatient Clinics, Greater Los Angeles Area
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University of Southern California Department of
Biokinesiology and Physical Therapy Coordinating
Center
Scientific Advisory Panel
Data Monitoring and Safety Committee
Network Sites
Randomized Clinical Trials Projects
University of Southern California
STEPS (CVA) Phase II/III
Rancho Los Amigos National Rehabilitation Center
Northwestern University
PEDALS (CP) Phase II
University of California, Los Angeles
Central Data Management and Analysis
MUSSEL (Spine) Phase II
Orthopaedic Hospital 7 pediatric practices in
LA MO
Missouri State University
STOMPS (SCI) Phase I
17 Outpatient Clinics, Greater Los Angeles Area
9
University of Southern California Department of
Biokinesiology and Physical Therapy Coordinating
Center
Scientific Advisory Panel
Data Monitoring and Safety Committee
Network Sites
Randomized Clinical Trials Projects
University of Southern California
STEPS (CVA) Phase II/III
Rancho Los Amigos National Rehabilitation Center
Northwestern University
PEDALS (CP) Phase II
University of California, Los Angeles
Central Data Management and Analysis
MUSSEL (Spine) Phase II
Orthopaedic Hospital 7 pediatric practices in
LA MO
Missouri State University
STOMPS (SCI) Phase I
17 Outpatient Clinics, Greater Los Angeles Area
10
University of Southern California Department of
Biokinesiology and Physical Therapy Coordinating
Center
Scientific Advisory Panel
Data Monitoring and Safety Committee
Network Sites
Randomized Clinical Trials Projects
University of Southern California
STEPS (CVA) Phase II/III
Rancho Los Amigos National Rehabilitation Center
Northwestern University
PEDALS (CP) Phase II
University of California, Los Angeles
Central Data Management and Analysis
MUSSEL (Spine) Phase II
Orthopaedic Hospital 7 pediatric practices in
LA MO
Missouri State University
STOMPS (SCI) Phase I
17 Outpatient Clinics, Greater Los Angeles Area
11
University of Southern California Department of
Biokinesiology and Physical Therapy Coordinating
Center
Scientific Advisory Panel
Data Monitoring and Safety Committee
Network Sites
Randomized Clinical Trials Projects
University of Southern California
STEPS (CVA) Phase II/III
Rancho Los Amigos National Rehabilitation Center
Northwestern University
PEDALS (CP) Phase II
University of California, Los Angeles
Central Data Management and Analysis
MUSSEL (Spine) Phase II
Orthopaedic Hospital 7 pediatric practices in
LA MO
Missouri State University
STOMPS (SCI) Phase I
17 Outpatient Clinics, Greater Los Angeles Area
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Coordinating Center

• Developed extensive manual of procedures
• Standardization of assessments and treatment
  protocols
• Available to other investigators
• Centralized data management statistical
  analysis
• Data management center directed by Dr. Stan Azen
• Facilitate communication among investigators and
  clinicians
• Monthly conference call
• Website
• Executive committee, publications committee, etc.

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www.pt.usc.edu/clinresnet
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Recruitment of subjects is now complete!
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Total recruitment 322 subjects
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Successful subject recruitment is a major
accomplishment!

• Estimated that 80 of all clinical trials fail to
  meet recruitment goals
• (Marks et al, Statist. Med. 2001 2026832696)
• Enhanced ability to recruit subjects for large
  clinical trials is a major advantage of clinical
  research networks

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Baseline Data is Now Available for Analysis

• Because some subjects are completing
  interventions and follow-up assessments,
  investigators remain blinded to group membership
• Post-intervention data still not available in
  complete form
• Thereforetodays presentation will focus on
  baseline data
• ICF Framework

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ICF Classification System

• International Classification of Functioning,
  Disability and Health
• Refinement of earlier WHO and Nagi Models of
  Disablement
• Overall Aim of ICF
• to provide a unified and standard language and
  framework for the classification and description
  of health and health-related states

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ICF Model
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Next

• How do we conceptualize outcome in terms of
  Quality of Life?

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Acknowledgments

• Funding from Foundation for Physical Therapy
• Guidance from Foundation staff and board
• Coordinating Center personnel
• Carolee Winstein (PI)
• Stan Azen (Director of DMC)
• Patricia Pate (Coordinator)