Summary. Haemophilia patients with inhibitors characteristically have impaired joint function and reduced health-related quality of life (HRQoL). This analysis examined whether secondary prophylaxis with recombinant activated factor VII (rFVIIa) improves HRQoL vs. conventional on-demand therapy in patients with haemophilia with inhibitors and frequent bleeds. After a 3-month preprophylaxis period, 22 patients received daily rFVIIa prophylaxis (90 or 270 lg kg )1 ) for 3 months, followed by 3 monthsÕ postprophylaxis. Days of hospitalization, absence from school/work and mobility aids requirements were recorded. HRQoL was assessed by EuroQoL (EQ-5D) questionnaire, visual analogue scale (VAS), derived Time to Trade-Off (TTO) scores and Quality Adjusted Life Years (QALYs). rFVIIa prophylaxis significantly (P < 0.0001) reduced bleeding frequency vs. prior on-demand therapy. Hospitalization (5.9% vs. 13.5%; P = 0.0026) and absenteeism from school/work (16.7% vs. 38.7%; P = 0.0127) decreased during prophylaxis; these effects tended to be maintained during postprophylaxis. HRQoL (evaluated by EQ-5D) tended to improve during and after rFVIIa prophylaxis. Notably, pain decreased and mobility increased in 40.9% and 27.3% of patients, respectively, at the end of the postprophylaxis period vs. preprophylaxis. Median VAS score increased from 66 to 73 (P = 0.048), and TTO scores suggested better HRQoL (0.62 vs. 0.76; P = 0.054) during postprophylaxis than preprophylaxis. Small to moderate changes in effect sizes were reported for VAS and TTO scores. Median QALYs were 0.68 (VAS) and 0.73 (TTO). Reductions in bleeding frequency with secondary rFVIIa prophylaxis were associated with improved HRQoL vs. on-demand therapy.
Background and Purpose: Depression is a frequent and important complication of stroke. Few data exist on the prevalence of depression/depressed mood after intracerebral hemorrhage (ICH) and the relationship between depression/depressed mood and the quality of life (QoL) more generally experienced by survivors of ICH. Methods: Factor Seven for Acute Hemorrhagic Stroke (FAST) was a randomized, multicenter, double-blind, placebo-controlled trial conducted between May 2005 and February 2007 at 122 sites in 22 countries. All patients were evaluated at day 90 after ICH onset for depressed mood and QoL with the Hamilton Depression Rating Scale (HDRS) and the EuroQoL, respectively. Multivariate stepwise logistic regression was used to develop a predictive model for depressed mood at day 90. Relationships between HDRS and EuroQoL scores at day 90 were evaluated with Spearman correlation coefficients. Results: 657 patients were alive at 3 months after ICH onset; 596 (91%) completed the HDRS. Twenty percent reported an HDRS score >10, indicating at least a minor degree of depressed mood; 6% endorsed symptoms of severely depressed mood. Significant predictors of depressed mood included comorbidities (p = 0.0022), moderate to severe neurological impairment according to the National Institutes of Health Stroke Scale (NIHSS) at day 15 (p = 0.0097), physical disability as measured by the Barthel Index (BI) at day 15 (p = 0.0486), and female gender (p = 0.04), but not hemorrhage severity or a history of depression. Irrespective of the presence of post-ICH disability and impairment, the severity of depressed mood at day 90 was significantly correlated with poor QoL. Conclusion: Depressed mood affects approximately 20% of ICH survivors and adversely affects QoL. Physicians should be vigilant to ensure that chronically ill and severely impaired survivors of ICH are adequately monitored and treated for depression after ICH.
The vast majority of survivors after intracerebral hemorrhage have very poor HRQOL. Critical care interventions designed to control blood pressure or prevent neuroworsening may improve HRQOL in intracerebral hemorrhage survivors.
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