Combined Sections Meeting, San Diego, CA, February 2, 2006

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

3. 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

4. Purpose of My Presentation • To provide a broad overview of PTClinResNet • To review ICF framework

5. 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 shouldersin chronic spinal cord injury • Bryan Kemp, Ph.D., Lead I

7. 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

8. 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

12. 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.

13. www.pt.usc.edu/clinresnet

14. Recruitment of subjects is now complete!

15. Total recruitment: 322 subjects

16. 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; 20:2683–2696) • Enhanced ability to recruit subjects for large clinical trials is a major advantage of clinical research networks

17. 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 • Therefore…today’s presentation will focus on baseline data • ICF Framework

18. 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

19. Contextual Factors ICF Model

20. Next… • How do we conceptualize outcome in terms of “Quality of Life”?

21. 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)