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Utility-Weighted Modified Rankin Scale as Primary Outcome in Stroke Trials: A Simulation Study.

Simone A Dijkland1, Daphne C Voormolen2, Esmee Venema2

  • 1From the Department of Public Health (S.A.D., D.C.V., E.V., S.P., J.A.H., D.N., V.C., E.W.S., H.F.L.), Department of Neurology (E.V., B.R., V.C., J.S., D.W.J.D.), and Department of Radiology (B.R., V.C., A.v.d.L.), Erasmus MC University Medical Center, Rotterdam, the Netherlands; Division of Neurointervention, Texas Stroke Institute, Dallas (A.J.Y.); Department of Neurology, Elisabeth TweeSteden Hospital, Tilburg, the Netherlands (J.S.); Department of Radiology (C.B.L.M.M.) and Department of Neurology (Y.B.W.E.M.R.), Academic Medical Center, Amsterdam, the Netherlands; Department of Radiology, Maastricht University Medical Center, the Netherlands (W.H.v.Z.); Department of Neurology, Cardiovascular Research Institute, Maastricht University Medical Center, the Netherlands (R.J.v.O.); and Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, the Netherlands (E.W.S.). s.dijkland@erasmusmc.nl.

Stroke
|March 15, 2018
PubMed
Summary

The utility-weighted modified Rankin Scale (UW-mRS) may reduce statistical power in stroke trials by not capturing individual patient utility variations. Ordinal analysis of the modified Rankin Scale (mRS) remains the most statistically efficient outcome measure.

Keywords:
brain ischemiaodds ratioquality of lifeself-reportstroke

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Area of Science:

  • Neurology
  • Clinical Trials
  • Health Economics

Background:

  • The utility-weighted modified Rankin Scale (UW-mRS) is a proposed patient-centered outcome for stroke trials.
  • Assessing the statistical efficiency of UW-mRS compared to other methods is crucial for trial design.

Purpose of the Study:

  • To describe utility weights for modified Rankin Scale (mRS) health states.
  • To evaluate the statistical efficiency of UW-mRS in detecting treatment effects in stroke intervention trials.

Main Methods:

  • Utilized data from 500 patients in the MR CLEAN trial.
  • Elicited utility values using the EuroQol Group 5-Dimension Self-Report Questionnaire at 90 days post-stroke.
  • Performed simulations to compare UW-mRS with dichotomized and ordinal mRS analyses for statistical power.

Main Results:

  • Mean utility values for mRS categories 0-6 ranged from 0.95 to 0, with significant individual variation.
  • UW-mRS demonstrated higher efficiency than dichotomous mRS (85% vs. 71% power).
  • Ordinal mRS analysis showed the highest statistical efficiency (87% power) compared to UW-mRS (85% power).

Conclusions:

  • The UW-mRS approach, by averaging utilities, does not account for individual patient variations.
  • This lack of individual variation capture may reduce the statistical power of randomized stroke trials.
  • Ordinal analysis of the mRS is statistically more efficient than the UW-mRS for detecting treatment effects.