Secondary Prophylaxis with rFVIIa Improves Quality of Life of Hemophilia Patients with Inhibitors and Frequent Bleeds.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 1028-1028 ◽  
Author(s):  
Barbara A. Konkle ◽  
Liselotte S. Ebbesen ◽  
Guenter K.H. Auerswald ◽  
Ute Friedrich ◽  
Rolf C.R. Ljung ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Treatment Period ◽  
Secondary Prophylaxis ◽  
Post Treatment ◽  
School Work ◽  
Post Hoc Analysis ◽  
On Demand ◽  
Post Hoc

Abstract Introduction: Patients with hemophilia and neutralizing antibodies (inhibitors) against exogenous factor VIII or factor IX characteristically have impaired joint function and more hospitalizations compared with those without inhibitors. We investigated the impact of secondary prophylaxis with activated recombinant factor VII (rFVIIa) on quality of life (QoL) and health-related quality of life (HRQL) in patients with congenital hemophilia A or B with inhibitors and high requirements for on-demand therapy. Methods: In a prospective, randomized, double-blind, uncontrolled trial, 22 patients (inhibitor titer >2 BU/mL; and ≥4 bleeds/month) received secondary prophylaxis with rFVIIa (90 or 270 μg/kg) once daily. This was preceded by a 3-month observation (baseline) period and followed by a 3-month post-treatment follow-up period in which patients were treated on-demand for their bleeds. QoL was evaluated by hospitalizations related to bleeds, days unable to attend/absence from school or work, or days requiring mobility aids. HRQL was assessed with the EuroQoL (EQ-5D), a 5-dimensional measure of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels (no problem; some or moderate problems; and extreme problems/impossible to do). Results: The clinically relevant reductions in bleed frequency observed with rFVIIa 90 or 270 μg/kg during prophylaxis (45% and 59%; p<0.0001 for both) compared with on-demand therapy during the observation period (baseline) were maintained during the 3-month follow-up period and were associated with improvements in QoL. The proportion of days during prophylaxis where patients were unable to attend/absent from school/work was significantly less than at baseline (16.7% vs 38.7%; p=0.0127, in a post-hoc analysis of the two treatment arms combined) and a significantly lower percentage of days was spent in hospital (5.9% vs 13.5%; p=0.0026 [post-hoc analysis]). During the post-treatment period, there were non-significant trends towards this effect being maintained (28.1% days absent from school/work, and 10.3% days spent in hospital). Overall use of mobility aids during prophylaxis and during the post-treatment period remained unchanged from that at baseline (post-hoc analysis). With EQ-5D, 2 of the measures (pain and mobility) showed trends towards improvement over time. Fewer patients tended to have pain and mobility problems during prophylaxis and during the post-treatment period. Conclusion: Prior to entry, patients enrolled in this trial bled frequently and overall had significant joint disease. Clinically relevant reductions in the number of bleeds observed during prophylaxis with rFVIIa compared with conventional on-demand therapy were associated with considerable improvements in QoL, reflected in a variety of important measures. Our results support the concept that secondary prophylaxis with rFVIIa in patients with severe hemophilia A or B with inhibitors and frequent bleeds improves the QoL of these disabled patients.

Randomized, Prospective Clinical Trial of rFVIIa for Secondary Prophylaxis in Hemophilia Patients with Inhibitors.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 766-766 ◽  
Author(s):  
Barbara A. Konkle ◽  
Liselotte S. Ebbesen ◽  
Ute Friedrich ◽  
Raul P. Bianco ◽  
Toshko Lissitchkov ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Secondary Prophylaxis ◽  
Post Treatment ◽  
Factor Vii ◽  
Double Blind ◽  
Once Daily ◽  
On Demand ◽  
Observation Period

Abstract Introduction: Hemophilia patients with inhibitors experience frequent bleeds and reduced quality of life (QoL). This trial evaluated whether once−daily prophylaxis therapy with activated recombinant factor VII (rFVIIa; 90 or 270 μg/kg) for 3 months can effectively reduce bleed frequency compared with on−demand therapy, without compromising safety. Methods: Thirty−eight hemophilia inhibitor patients with frequent bleeds entered a 3−month observation period where on−demand therapy was continued according to local practice. Twenty−two patients with a stable bleed frequency (≥4 bleeds/month) were randomized 1:1 to once−daily dosing with 90 or 270 μg/kg rFVIIa in a double−blind, parallel−group design. To maintain blinding, the same volume was administered in both groups. Patients then entered a 3−month post−treatment observation period, where on−demand therapy was resumed. Results: The number of bleeds per month was significantly reduced by 45% and 59% with 90 or 270 μg/kg rFVIIa prophylaxis, respectively, compared with the observation period (Fig.). Similar reductions were seen for all bleeds, irrespective of site or cause. The majority of this reduced bleeding frequency was maintained in the 3 month post−treatment period (27% and 50% reductions, respectively). There were no treatment− or dose−dependent patterns in the number or type of adverse events. No thromboembolic events or withdrawals due to adverse events or ineffective treatment were reported. The benefits of reducing bleeding frequency in this trial translated into improvements in QoL. Conclusions: These results support the concept of secondary rFVIIa prophylaxis in inhibitor patients with frequent bleeds. Clinically relevant reductions in number of bleeds and improvements in quality of life were observed during prophylaxis compared with conventional on−demand therapy without raising any safety concerns. Figure Figure

Long term follow-up of quality of life and functional ability in patients with ICU acquired Weakness – A post hoc analysis

2019 ◽  
Vol 53 ◽  
pp. 223-230 ◽  
Author(s):  
Georgios Sidiras ◽  
Irini Patsaki ◽  
Eleftherios Karatzanos ◽  
Maria Dakoutrou ◽  
Alexandros Kouvarakos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Functional Ability ◽  
Post Hoc Analysis ◽  
Long Term Follow Up ◽  
Post Hoc ◽  
Icu Acquired Weakness

scholarly journals Effectiveness of the Electromagnetic Shock Wave Therapy in the Treatment of Cellulite

2019 ◽  
Vol 2019 ◽  
pp. 1-6 ◽  
Author(s):  
Débora Apª O. Modena ◽  
Caroline Nogueira da Silva ◽  
Talita C. P. Delinocente ◽  
Tatiane Bianca de Araújo ◽  
Tania Maria de Carvalho ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Evaluation Method ◽  
The Body ◽  
P Value ◽  
Therapeutic Modalities ◽  
Shockwave Therapy ◽  
Deformation Ability ◽  
Post Hoc

In the past centuries, the human body was undervalued; nowadays, however, it is overvalued, and thus the manifestation of the dissatisfactions regarding the body has been increasing. Most of the time, these dissatisfactions are related to cellulite, which is most common in women. Its treatment is one of the challenges which encourage the development of new therapeutic modalities, among them the shockwave therapy. Objective. To evaluate the efficacy of ESWT in the treatment of cellulite in gluteus and posterior of thigh. Method. This is a prospective and comparative study, in which volunteer women who attended the criteria of inclusion were selected and who were subjected to 10 sessions of ESWT. The following were performed as an evaluation method: anthropometry, perimetry, skin viscoelasticity with the Cutometer®, thickness of hypodermis with diagnostic ultrasound, analysis of the scale of severity of cellulite (CSS), and quality of life by the Celluqol® questionnaire. The evaluations occurred before the first session (baseline), after 6 and 10 sessions, and during a follow-up of 3 months after the last session. The statistical test applied was the ANOVA one-way with post hoc of Tukey (P-value < 0.05). Results. There was significant improvement (P<0.05) for CSS, for the variable referring to gross elasticity and skin deformation ability evaluated in the Cutometer® and improvement of quality of life represented by Celluqol®. The result was maintained particularly in the follow-up of 3 months after the end of the treatment. Conclusion. The results presented demonstrated the effectiveness and safety of ESWT in the treatment of cellulite and in the decrease of the degrees, improvement of the aspect of the skin, and reestablishment of quality of life. This trial is registered with ClinicalTrials: NCT03275259.

scholarly journals Time Course of Autonomic Symptoms in Postural Orthostatic Tachycardia Syndrome (POTS) Patients: Two-Year Follow-Up Results

2020 ◽  
Vol 17 (16) ◽  
pp. 5872
Author(s):  
Franca Dipaola ◽  
Caterina Barberi ◽  
Elena Castelnuovo ◽  
Maura Minonzio ◽  
Roberto Fornerone ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Repeated Measures ◽  
Time Course ◽  
Orthostatic Intolerance ◽  
Occupational Status ◽  
Postural Orthostatic Tachycardia Syndrome ◽  
Autonomic Symptoms ◽  
Post Hoc

Postural orthostatic tachycardia syndrome (POTS) is a multifactorial condition capable of chronically reducing the quality of life and the work ability of patients. The study aim was to assess the burden of autonomic symptoms in a cohort of POTS patients over 2 years. Patients’ clinical profiles were assessed by the 31-item Composite Autonomic Symptom Score questionnaire (COMPASS 31) and a visual analog scale (VAS). One-way ANOVA for repeated measures followed by Dunnett’s post-hoc test were used to compare symptoms at baseline and at 1 and 2 years. Out of 42 enrolled patients, 25 had a 1-year follow-up and 12 had a 2-year follow-up. At baseline, the reported burden of autonomic symptoms was high (overall COMPASS 31 = 49.9 ± 14.3 /100). Main complaints were related to orthostatic intolerance according to both COMPASS 31 and VAS. Fourteen patients were rendered inactive because of symptoms. At 1-year follow-up, a statistically significant improvement in pupillomotor function and overall score was detected by the COMPASS 31. These findings were confirmed at 2 years, together with a significant reduction in quality of life impairment, assessed by VAS. However, these improvements did not change patients’ occupational status. Awareness of POTS diagnosis, patient monitoring, and tailored therapies can help to improve patients’ condition.

scholarly journals Influence of Craniosacral Therapy on Anxiety, Depression and Quality of Life in Patients with Fibromyalgia

2011 ◽  
Vol 2011 ◽  
pp. 1-9 ◽  
Author(s):  
Guillermo A. Matarán-Peñarrocha ◽  
Adelaida María Castro-Sánchez ◽  
Gloria Carballo García ◽  
Carmen Moreno-Lorenzo ◽  
Tesifón Parrón Carreño ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Sleep Quality ◽  
Treatment Period ◽  
Quality Index ◽  
Pittsburgh Sleep Quality Index ◽  
Intervention Group ◽  
Craniosacral Therapy

Fibromyalgia is considered as a combination of physical, psychological and social disabilities. The causes of pathologic mechanism underlying fibromyalgia are unknown, but fibromyalgia may lead to reduced quality of life. The objective of this study was to analyze the repercussions of craniosacral therapy on depression, anxiety and quality of life in fibromyalgia patients with painful symptoms. An experimental, double-blind longitudinal clinical trial design was undertaken. Eighty-four patients diagnosed with fibromyalgia were randomly assigned to an intervention group (craniosacral therapy) or placebo group (simulated treatment with disconnected ultrasound). The treatment period was 25 weeks. Anxiety, pain, sleep quality, depression and quality of life were determined at baseline and at 10 minutes, 6 months and 1-year post-treatment. State anxiety and trait anxiety, pain, quality of life and Pittsburgh sleep quality index were significantly higher in the intervention versus placebo group after the treatment period and at the 6-month follow-up. However, at the 1-year follow-up, the groups only differed in the Pittsburgh sleep quality index. Approaching fibromyalgia by means of craniosacral therapy contributes to improving anxiety and quality of life levels in these patients.

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