Desirable Characteristics of Clinical Trials on Rehabilitative Strategies for Stroke

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=43 | meeting_date=2008-05-21

Actions Taken: April 14, 2008 Posted Federal Register Notice and Questions to Panel May 14, 2008 Posted technology assessment 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]. Agenda: 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) ****************************************************************************** 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. ****************************************************************************** 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 Minutes: Download meeting minutes [PDF, 47KB] Other Material: Transcript 1 Panel Voting Questions: [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? Protocol driven usual treatment versus protocol driven usual treatment using the same parameters plus the specified intervention patient him/herself, before and after intervention patient him/herself, before and after treatment then with treatment withdrawn and reinstituted (as appropriate) non-protocol driven usual care versus intervention [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: natural clinical course of recovery selection bias due to: skill level of therapist comorbidities affecting both the stroke etiology and course of recovery ancillary therapeutic resources (e.g. virtual home/community environments) severity of illness differing assessment tools used across care settings (inpatient rehabilitation facilities, skilled nursing facilities, home health agencies, outpatient centers) pre-morbid and cultural characteristics discharge settings and social support [VOTE] What is the minimum period of time that interventions be followed in order to identify a durable treatment effect? 0-6 months 6-12 months 12-18 months > 18 months [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? Barthel Index Six minute walk Functional Independence Measure (FIM) Fugl-Meyer Assessment [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? Aphasia Quotient of the Western Aphasia Battery (WAB) Porch Index of Communicative Ability [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? coughing/choking frequency during a meal videofluoroscopy [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? Barthel Index Modified Ashworth Scale EuroQoL: Quality of life for patient and carer [caregiver] [VOTE] How important are caregiver burden and their narratives as indices of successful rehabilitation? [VOTE] How confident are you that these conclusions can be generalized to community practice settings outside the context of specialized treatment centers? [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] Roster: 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