Abstract
Introduction: Clinical trial outcomes such as the modified Rankin score (mRS) are heavily influenced by mobility. We examined if mobility impairment and functional disability influenced long-term overall health evaluation by survivors of intracerebral and intraventricular hemorrhage (ICH/IVH). Methods: We pooled data from MISTIE-III and CLEAR-III trials. ICH/IVH survivors performed a protocolized direct valuation of their overall health using time trade-off utility (TTO-U) at 6 months post-ictus. TTO-U asks responders to consider trading years off their current disability-stricken state in exchange for perfect health. TTO-U index ranges from 0-1, with lower scores indicating greater years traded off and poorer valuation of overall health. TTO-U scores were dichotomized as good (>=0.7) and poor (<0.7). Associations between functional outcomes, European quality of life 5 dimensions (EQ-5D) and poor TTO-U at 6-months were assessed in multivariable logistic regression. A mediation analysis evaluated if mobility impairment and persistent poor mRS (mRS4-5) mediated associations between significant covariates and poor TTO-U at 6-months. Results: Of 773 survivors at 6-months, 442 (57%) patients with median (IQR) mRS of 3 (3-4) reported median (IQR) TTO-U of 1 (0.7-1); 332 patients had good and 110 had poor TTO-U. In multivariable logistic regression, moderate to severe anxiety/depression and problems with selfcare (dressing/washing) were independently associated with poor valuation of overall health, but mobility impairment and poor functional outcome were not. In mediation analyses, mobility impairment and poor mRS (4-5) at 6-months did not mediate the effect of persistent anxiety/depression (controlled direct effect (CDE), 1.79 [1.10-2.89]; natural indirect effect (NIE) of mobility, 0.93 [0.58-1.49], p=0.75; NIE of mRS, 1.00 [0.91-1.10], p=0.96) and selfcare deficits (CDE, 4.85 [2.13-11.05]; NIE of mobility, 0.72 [0.42-1.26]; NIE of mRS, 1.04 [0.78-1.39]) on long-term valuation of health state. Conclusions: Long-term valuation of overall health in survivors after severe ICH/IVH was influenced by persistent dependence in caring for self and mood dysfunction. Mobility impairment and mRS did not mediate these associations.
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