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Representative Utility Values for the modified Rankin

Award Number: K23NS144639
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2031

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Representative Utility Values for the modified Rankin - Project Summary/Abstract Individuals living with a functional disability are commonly excluded from acute ischemic stroke (AIS) clinical trials, leading to a lack of evidence-based acute stroke care for this growing population. Shortcomings of the modified Rankin Scale (mRS), the most common acute stroke trial endpoint, are partly responsible for this gap in evidence-based care. Therapeutic efficacy for acute stroke is commonly measured by the degree to which a therapy improves functional independence, defined as mRS 0-2 (ranging from 0-6, with higher scores describing increasing levels of functional disability). Because patients with disability before stroke (mRS ≥ 2) rarely achieve this outcome, they are commonly excluded from acute stroke trials. The Utility-Weighted mRS (UW-mRS), in which a patient-centered “utility value” - the desirability of a health state to the patient - is assigned to each category of the mRS, is an endpoint that can be used to include pre-stroke disabled patients in clinical trials. However, there is a reluctance to use the UW-mRS for two reasons. First, the generalizability of trials using the UW-mRS are limited given current mRS utility values were derived from populations not representative of the US stroke population. Second, the UW-mRS may not accurately capture treatment effects for pre-stroke disabled patients, as these patients may value a given mRS functional status differently compared to patients without pre-stroke disability. The Representative UtiLity Values for the modifiEd Rankin-II (RULER-II) study will address these limitations through a multicenter, prospective study to 1) establish mRS utility values from a representative US stroke population, and 2) test the hypothesis that patients with pre- stroke disability value a given 90-day post-stroke mRS category with a higher utility (better quality-of-life) compared to patients without pre-stroke disability. These aims will establish the UW-mRS as a robust stroke trial endpoint that will provide trialists with rigorous methodology to include patients with pre-stroke disability in future trials. This research proposal, in conjunction with the career development plan, will position Dr. Wechsler to be an expert clinical trialist focused on using innovative trial design to make stroke clinical trial populations more representative of patients encountered in routine clinical care. Execution of the research study will provide him with expertise in executing multicenter prospective stroke studies. The career development activities will provide scholarship in 1) clinical trial methodology, and 2) clinical research informatics to embed clinical trials in the electronic health record (EHR). Fusing these skillsets will position Dr. Wechsler to lead EHR-embedded stroke clinical trials that increase stroke trial representativeness by reducing operational barriers to trial participation for inclusion of patients encountered in routine clinical care from care settings that lack research infrastructure. Dr. Wechsler will be guided by a team of expert mentors: Dr. Eva Mistry, a stroke clinical trialist with expertise in innovative trial design; Dr. Jeffrey Saver, a methodologic expert in the UW- mRS; and Dr. Umberto Tachinardi, a leader in using informatics for efficient conduct of clinical research.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $250,830 )
2026	2026	CINCINNATI UNIV OF	2600 CLIFTON AVE	CINCINNATI	OH	45220	HAMILTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	8/28/2026	NEW	$250,830
														Subtotal = $250,830

Grand Total All Awards = $250,830

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Representative Utility Values for the modified Rankin

Award Number: K23NS144639

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2031

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