Comparing clinician- and patient-reported outcome measures after hemicraniectomy for ischemic stroke.

Background: The association between clinician- and patient-reported health status measures (HSM) after hemicraniectomy for ischemic stroke is understudied. We compared HSMs to determine how HSM type and follow-up affect the interpretation of outcomes.

Methods: We identified patients that underwent hemicraniectomy for ischemic stroke at the Cleveland Clinic (CC) from January 2009 through May 2013. HSMs were obtained from the CC Knowledge Program Data Registry. Outpatient follow-up was divided into "Early" (3±2 months (standard deviation)) and "Late" (9±3 months) time periods. Clinician-reported HSMs (National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS)) were compared to patient-reported HSMs (EuroQol quality of life index (EQ-5D), Patient Health Questionnaire-9 (PHQ-9), and the Stroke Impact Scale-16 (SIS-16)).

Results: 11 of 32 patients completed all HSMs during both follow-up periods. Clinician-reported median NIHSS scores improved from 12 to 7 (p=0.003). Median mRS scores demonstrated little improvement from 4 to 3 (p=0.2). Patient-reported median EQ-5D scores improved from 0.33 to 0.69 (p=0.03). Among EQ-5D sub-scores, "usual activity" improved from a median score of 3 (extreme problems) to 2 (some problems) (p=0.008). Median PHQ-9 scores improved from 9 to 1 (p=0.06) as did SIS-16 scores from 23 to 57 (p=0.01). EQ-5D and mRS score differences between periods were correlated (r=-0.65, p=0.03), but only the EQ-5D showed significant improvement over time.

Conclusions: Both HSM types, clinician- and patient-reported outcome measures, improved over time. The structure of clinical trials, and, in particular, defining clinical endpoints and framing outcomes, has a profound impact on the interpretation of what a "favorable" outcome means.