Comments to NINDS on Stroke Research Priorities
Submitted June 28, 2012
NINDS’s RFI invites input on priorities for the stroke research community to address over the next 5-10 years. The priorities should represent cross-cutting research opportunities that have a high probability of leading to a major advance in our biologic understanding or treatment of the disease.
Identify and provide your input on up to three high priority stroke research efforts that if completed over the next 5-10 years would lead to major advances in stroke science. We are interested in basic, translational, and/or clinical research areas as well as approaches that cut across these areas. Please note that you do not need to be a stroke specialist to respond, and we welcome input from related disciplines.
Your input will be used by the planning panel during their consideration of the research priorities. For each topic submitted, please comment on these five elements:
a) Description – The challenge, opportunity or research question for the stroke field to address, and indicate its relevance to one or more of the following three areas: prevention, acute treatment, or recovery and rehabilitation.
b) Rationale – The background or scientific evidence that forms the basis for this research topic/question.
c) Readiness – Whether the opportunity or challenge is primed for action now and what the expected deliverables would be after a 5-10 year effort (considering strategic advantages of the current state of the science, infrastructure capacity, new technologies, new discoveries, etc.), or if this is a newer area of science that needs to be further developed now because of its great potential for high scientific payoff in the future (i.e. high risk/high reward, but longer time frame).
d) Impact -- The immediate and long-term impacts that accomplishment in this area or answering this stroke research question would have on the science and on public health. This can include justifying why this is a national stroke research priority.
e) Approach -- Potential approach or study design to pursue the scientific opportunity (team science, centers of excellence, science challenge, prospective randomized trial, epidemiologic study, prospective data collection without randomization, etc.). Include who in the research community would need to become engaged, and whether existing infrastructure or research capacity is sufficient or would need to be developed. Also indicate any barriers that need to be overcome to allow this area to move forward and suggest strategies for addressing them.
1. Measure What Matters to Stroke Survivors
A. The challenge for rehabilitation and recovery from stroke is a paucity of valid, reliable, and clinically sensitive measures of daily activities (e.g., Basic Activities of Daily Living, Instrumental Activities of Daily Living, social functioning) and participation.
With increasing numbers of the elderly population anticipated in the next decade, rehabilitation needs for stroke survivors will likely increase. Yet, many of the measures currently used in practice are not measuring what matters most to clients and their families, which is returning to their lives by performing their meaningful roles and daily activities. Moreover, fiscal pressures on health care will call for increased scrutiny of rehabilitation interventions that are truly effective and clinically significant. However, many of the measures purported to measure function are measuring performance at the impairment level of the World Health Organization’s International Classification of Function (ICF) Model.
Commonly used measures such as the Fugl-Meyer Assessment and Wolf Motor Function Test provide information about arm and hand movements and some task-related movements such as picking up a pencil or turning a key with the more affected arm, but these tests do not tell us if our rehabilitation clients can bathe/shower, dress themselves, cook, or do the laundry – occupations of daily living. The often utilized Functional Independence Measure (FIM) measures level of ability or burden of care, not the quality and extent of using a hemiparetic arm during functional activities.
We urgently need psychometrically sound performance-based tests that measure performance of daily activities and participation in clinical and community environments.
This challenge is primed for action because NIH and others have invested in building research capacity so there are better-trained researchers who understand instrument development and rehabilitation practice. The deliverables after 10 years would be several valid, reliable, and sensitive standardized measures of stroke survivors’ daily functioning (e.g., dressing, bathing, toileting, cooking, etc.) across the lifespan.
Clinicians may assume that interventions directed at the body structure and function level of the ICF will cause improved activity and participation but research does not strongly support this long-held assumption. The short-term impact of this Measure What Matters initiative would be increased research on Activity and Participation Outcomes of stroke survivors. The long-term impact would be a more efficient and functionally-relevant outcome measure that researchers could incorporate into their efficacy and pragmatic trials.
Funding centers with teams who are experienced with instrument development would most likely be the most efficient approach, since they have the staff and resources to develop or refine instruments. Although patient-reported outcomes are being used often, performance-based measures also are important, especially when some stroke survivors are impulsive or demonstrate poor judgment, and therefore may not provide reliable reports about their level of functioning.