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MEDCAC Meeting 5/21/2008 - Desirable Characteristics of Clinical Trials on Rehabilitative Strategies for Stroke

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April 14, 2008

Posted Federal Register Notice and Questions to Panel

May 14, 2008

May 19, 2008

Posted Agenda and Roster.

May 21, 2008

Posted Questions  to panel.

June 3, 2008

Posted scoresheet from meeting.

July 24, 2008

Posted minutes [PDF, 47KB] and transcript  [PDF, 340KB].
Federal Register Notice
Agenda
Medicare Evidence Development & Coverage Advisory Committee
May 21, 2008
7:30 AM – 4:30 PM
CMS Auditorium

Saty Satya-Murti, MD, FAAN, Acting Chair
Louis Jacques, MD, Coverage and Analysis Group
Maria Ellis, Executive Secretary


7:30 – 8:00 AM

Registration

8:00 – 8:15 AM

Opening Remarks—M. Ellis / L. Jacques, MD/ Saty Satya-Murti, MD, FAAN

8:15- 8:55 AM

CMS Presentation of the Voting Questions – Jean Stiller/Susan Miller, MD

8:55 – 9:40 AM

TA Presentation: Mark Oremus, PhD and Pasquilina Santaguida, PhD, McMaster University Evidence-Based Practice Center, Hamilton, Ontario Canada

9:40 – 10:05 AM

Pamela W. Duncan, Phd, PT, FAPTA, Professor Division of Physical Therapy, Department of Community and Family Medicine, Duke Center for Clinical Health Policy Research

10:05 - 10:30 AM

Stephanie A. Studenski, MD, MPH, Professor of Medicine Director of Clinical Research, University of Pittsburgh Institute on Aging

10:30 - 10:45 AM

BREAK

10:45 –11:15 AM

Scheduled Public Comments (Refer to Speaker List)

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Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting.

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11:15 – 11:35 AM

Open Public Comments

11:35 – 12:35 PM

LUNCH (on your own)

12:35 –1:35 PM

Questions to Presenters

1:35 – 2:45PM

Initial Open Panel Discussion: Dr. Satya-Murti

2:45 – 3:30 PM

Formal Remarks and Voting Questions

The Chairperson will ask each panel member to state his or her position on the voting questions

3:30 – 4:25 PM

Final Open Panel Discussion: Dr. Satya-Murti

4:25 – 4:30 PM

Closing Remarks / Adjournment: Dr. Jacques & Dr. Satya-Murti

4:30 PM

ADJOURN

Download meeting minutes [PDF, 47KB]

  1. [VOTE: Confidence level on each] There is the tendency to generalize stroke research to large, heterogeneous populations. How confident are you that the strategies below represent meaningful comparators in observational studies?
    1. Protocol driven usual treatment versus protocol driven usual treatment using the same parameters plus the specified intervention
    2. patient him/herself, before and after intervention
    3. patient him/herself, before and after treatment then with treatment withdrawn and reinstituted (as appropriate)
    4. non-protocol driven usual care versus intervention
  2. [NO VOTE] Large prospective randomized trials are uncommon in this field of medicine. Discuss how other study designs can or cannot adequately account for potential confounding factors such as:
    1. natural clinical course of recovery
    2. selection bias due to:
      1. skill level of therapist
      2. comorbidities affecting both the stroke etiology and course of recovery
      3. ancillary therapeutic resources (e.g. virtual home/community environments)
      4. severity of illness
    3. differing assessment tools used across care settings (inpatient rehabilitation facilities, skilled nursing facilities, home health agencies, outpatient centers)
    4. pre-morbid and cultural characteristics
    5. discharge settings and social support
  3. [VOTE] What is the minimum period of time that interventions be followed in order to identify a durable treatment effect?
    1. 0-6 months
    2. 6-12 months
    3. 12-18 months
    4. > 18 months
  4. [VOTE] How confident are you that each of the following outcome measures is a reliable, valid and responsive indicator of change in clinical trials that aim to improve an individual’s functional capacity in the performance of ADLs/IADLs and locomotion/transfer abilities?
    1. Barthel Index
    2. Six minute walk
    3. Functional Independence Measure (FIM)
    4. Fugl-Meyer Assessment
  5. [VOTE] How confident are you that each of the following outcome measures is a reliable, valid and responsive indicator in clinical trials of therapies to improve an individual’s functional capacity in the performance of language and communication skills?
    1. Aphasia Quotient of the Western Aphasia Battery (WAB)
    2. Porch Index of Communicative Ability
  6. [VOTE] How confident are you that each of the following outcome measures is a reliable, valid and responsive indicator in clinical trials of therapies to improve an individual’s functional capacity in the performance of swallowing?
    1. coughing/choking frequency during a meal
    2. videofluoroscopy
  7. [VOTE] How confident are you that each of the following outcome measures is a reliable, valid and responsive indicator in clinical trials to assess patient, proxy, or caregiver perceptions of the patient’s health and satisfaction with life and community re-integration?
    1. Barthel Index
    2. Modified Ashworth Scale
    3. EuroQoL: Quality of life for patient and carer [caregiver]
  8. [VOTE] How important are caregiver burden and their narratives as indices of successful rehabilitation?
  9. [VOTE] How confident are you that these conclusions can be generalized to community practice settings outside the context of specialized treatment centers?
  10. [VOTE] How confident are you that these conclusions can be generalized to the population of Medicare beneficiaries?

[DISCUSS] What are the gaps in the current evidence on stroke rehabilitation therapies in Medicare beneficiaries?

Download Scoresheet  - XLS version [ZIP, 86KB]

Download Scoresheet  - PDF version [PDF, 640KB]

Marion Danis, MD
Chief, Bioethics Consultation Service
NIH Clinical Center

Daniel D. Foley, MD
Vice President, Medical Affairs and
Medical Director
United Hospital of St. Paul
Allina Health System

Mark D. Grant, MD, MPH
Senior Scientist
BlueCross BlueShield Association
Technology Evaluation Center

Spencer H. Kubo, MD
Acorn Cardiovascular, Inc.

Stephen L. Ondra, MD
Associate Professor of Neurological
Surgery, Dept. of Neurological Surgery
Northwestern Medical Faculty
Foundation

Stephen Pauker, MD
Division of Clinical Decision Making
Tufts Medical Center
Professor of Medicine
Tufts University School of Medicine

Saty Satya-Murti, MD, FAAN
Health Policy Consultant

Andrew Sloan, MD, FACS
Staff Neurosurgeon
Department of Neurosurgery
University Hospitals of Cleveland

Jonathan P. Weiner, PhD
Professor & Deputy Director
Health Services Research &
Development Center
The Johns Hopkins University

Consumer Representative
Randel Richner, BSN, MPH
President and Founder
Neocure Group, LLC

Industry Representative
Jose Alvir, Dr.PH
Director, Statistics, Outcomes Research
Clinical Research and Development
Pfizer, Inc.

Patient Advocate
Leslie B. Fried, JD, MPH
American Bar Association
Commission on Law & Aging

Guest Panel Members
Naomi Lynn Hurwitz Gerber, MD
Director
Center for Chronic Illness and Disability
George Mason University

Elliott J. Roth, MD
Professor and Chairman
Physical Medicine & Rehabilitation
Senior Vice President and Chief
Academic Officer
Rehabilitation Institute of Chicago

Guest Speakers
Pamela W. Duncan, PhD, PT, FAPTA
Professor
Division of Physical Therapy
Department of Community and Family
Medicine
Duke Center for Clinical Health Policy
Research

Stephanie A. Studenski, MD, MPH
Professor of Medicine
Director of Clinical Research
University of Pittsburgh Institute on
Aging

CMS Liaison
Louis Jacques, MD
Director
Division of Items and Devices
Coverage and Analysis Group

Executive Secretary
Maria Ellis

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