Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients

Xia Wang, Tom J. Moullaali, Qiang Li, Eivind Berge, Thompson G. Robinson, Richard Lindley, Danni Zheng, Candice Delcourt, Hisatomi Arima, Lili Song, Xiaoying Chen, Jie Yang, John Chalmers, C. Anderson, Else Charlotte Sandset

Research output: Contribution to journalArticle

Abstract


Background and Purpose: Patient-centered care prioritizes patient beliefs and values towards wellbeing. We aimed to map functional status (modified Rankin Scale [MRS] scores) and health-related quality of life on the European Quality of Life 5-dimensional questionnaire (EQ-5D) to derive utility-weighted (UW) stroke outcome measures and test their statistical properties and construct validity. Methods: UW-MRS scores were derived using linear regression, with MRS as a discrete ordinal explanatory response variable in 8 large international acute stroke trials. Linear regression models were used to validate UW-MRS scores by assessing differences in mean UW-MRS scores between the treatment groups of each trial. To explore the variability in EQ-5D between individual MRS categories, we generated receiver operator characteristic curves for EQ-5D to differentiate between sequential MRS categories and misclassification matrix to classify individual patients into a matched MRS category based on the closest UW-MRS value to their observed individual EQ-5D value. Results: Among 22 946 acute stroke patients, derived UW-MRS across MRS scores 0 to 6 were 0.96, 0.83, 0.72, 0.54, 0.22,-0.18, and 0, respectively. Both UW-MRS and ordinal MRS scores captured divergent treatment effects across all 8 acute stroke trials. The sample sizes required to detect the treatment effects using UW-MRS scores as a continuous variable were almost half that required in trials for a binary cut point on the MRS. Area under receiver operator characteristic curves based on EQ-5D utility values varied from 0.66 to 0.81. Misclassification matrix showed moderate agreement between actual and matched MRS scores (kappa, 0.68 [95% CI, 0.67-0.68]). Conclusions: Medical strategies that target avoiding dependency may provide maximum benefit in terms of poststroke health-related quality of life. Despite variable differences with MRS scores, the UW-MRS provides efficiency gains as a smaller sample size is required to detect a treatment effect in acute stroke trials through use of continuous scores. Registration: URL: Https://www.clinicaltrials.gov; Unique identifiers: NCT00226096, NCT00716079, NCT01422616, NCT02162017, NCT00120003, NCT02123875. URL: Http://ctri.nic.in; Unique identifier: CTRI/2013/04/003557. URL: Https://www.isrctn.com; Unique identifier: ISRCTN89712435.

Original languageEnglish
Pages (from-to)2411-2417
Number of pages7
JournalStroke
Volume51
Issue number8
DOIs
Publication statusPublished - Aug 2020
Externally publishedYes

Keywords

  • clinical trial
  • patient-centered care
  • quality of life
  • sample size
  • stroke

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