Desirable Characteristics of Clinical Trials on Rehabilitative Strategies for Stroke

April 14, 2008

May 14, 2008

May 19, 2008

May 21, 2008

June 3, 2008

July 24, 2008

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

7:30 - 8:00 AM

8:00 - 8:15 AM

8:15- 8:55 AM

8:55 - 9:40 AM

9:40 - 10:05 AM

10:05 - 10:30 AM

10:30 - 10:45 AM

10:45 -11:15 AM

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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

11:35 - 12:35 PM

12:35 -1:35 PM

1:35 - 2:45PM

2:45 - 3:30 PM

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

3:30 - 4:25 PM

4:25 - 4:30 PM

4:30 PM

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 patient him/herself, before and after treatment then with treatment withdrawn and reinstituted (as appropriate)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?

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