scholarly journals AB0343 BETTER QUALITY OF LIFE AND ADHERENCE WITH LESS ADVERSE EVENTS WHEN SWITCHING FROM ORAL TO SUBCUTANEOUS METHOTREXATE: RESULTS OF THE SIX-MONTH OBSERVATIONAL PROSPECTIVE STUDY IN CROATIA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1471.2-1471
Author(s):  
S. Grazio ◽  
D. Perković ◽  
N. Laktašić Žerjavić ◽  
F. Grubisic ◽  
M. Glasnović ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Longitudinal Study ◽  
Adverse Events ◽  
Disease Duration ◽  
Health Assessment ◽  
Outpatient Clinics ◽  
Median Dose ◽  
Number Of Patients

Background:It has been demonstrated that bioavailability of oral (P.O.) MTX reaches plateau at doses ≥15 mg QW, and that subcutaneous (S.C.) form has a better efficacy. Alongside with less side-effects this might translate into improvement in quality of life (QoL) and better adherence.Objectives:An academic-induced observational longitudinal study of patients with RA and peripheral form of PsA on csDMARDs who were switched from oral (P.O.) to subcutaneous (S.C.) MTX was conducted. Previously we reported on the better efficacy of S.C. compared to P.O. MTX. The objective of this part of the study we are presenting was to evaluate the 6-month changes in quality of life (QoL), adverse events and adherence in these patients.Methods:Forty-eight consecutive patients (79.2% women) with established diagnosis of RA (77.1%) and peripheral PsA were enrolled from the outpatient clinics in six centres in Croatia. Median age was 61 (39-79) years, and the median of disease duration was 120 (3-528) months. Data were collected at baseline (T0) (on P.O. MTX), at day 90 (±10 days) (T1) and at day 180 (±10 days) (T2), during S.C. MTX treatment. Median dose of MTX remained stable during the study (15mg QW). At each visit QoL was measured using EuroQuol-5D (EQ-5D), adverse events related to MTX use were recorded, and adherence by the number of missed dose.Results:EQ-5D global health assessment showed significant improvement in quality of life of patients on S.C. MTX during the 6 month follow-up (change from T0 to T2 8.6; 95%CI 4.00, 13.3), and the same trend was observed in each of its five component. Number of patients who experienced adverse events related to MTX use has decrease after switching from P.O. to S.C.MTX – from 52.1% during the last 3 months on P.O. MTX to 33.3% during the first 3 months and 18.2% during the last 3 months of S.C. MTX use. During the follow-up adherence to MTX therapy improved, with 25% of patients who missed dose during the last 3 months on P.O. MTX use, to 6,3% and 2.3% with missed dose in the first and the last 3 months on S.C. MTX, respectively.Conclusion:In our group of patients with RA and peripheral PsA who switched from P.O. to S.C. MTX there was a consistent improvement in QoL, less adverse-events and better adherence.Disclosure of Interests:Simeon Grazio Speakers bureau: Abbvie., Roche, MSD, Eli Lilly, Pfizer, Mylan, Amgen, Fresenius Kabi, Stada, Berlin-Chemie, Dijana Perković Speakers bureau: Abbvie., Roche, MSD, Eli Lilly, Pfizer, Mylan, Amgen, Fresenius Kabi, Nadica Laktašić Žerjavić Speakers bureau: Abbvie., Roche, MSD, Eli Lilly, Pfizer, Mylan, Amgen, Fresenius Kabi, Frane Grubisic Speakers bureau: Abbvie., Roche, MSD, Eli Lilly, Pfizer, Mylan, Amgen, Marija Glasnović Speakers bureau: Abbvie, Roche, Pfizer, Ana Gudelj Gračanin Speakers bureau: Abbvie. Roche, MSD, Eli Lilly, Pfizer, Željka Kolak: None declared, Helena Kolar Mitrović: None declared, Jadranka Morovic-Vergles Speakers bureau: Abbvie., Roche, MSD, Eli Lilly, Pfizer, Mylan, Amgen, Fresenius Kabi, Porin Perić: None declared, Petra Šimac: None declared, Iva Žagar Speakers bureau: Abbvie. Roche, MSD, Eli Lilly, Pfizer, Ines Doko Speakers bureau: Abbvie. Roche, Vladimir Trkulja: None declared

scholarly journals Drooling in Parkinson’s Disease: Prevalence and Progression from the Non-motor International Longitudinal Study

Dysphagia ◽  
2020 ◽  
Vol 35 (6) ◽  
pp. 955-961 ◽  
Author(s):  
Daniel J. van Wamelen ◽  
Valentina Leta ◽  
Julia Johnson ◽  
Claudia Lazcano Ocampo ◽  
Aleksandra M. Podlewska ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Longitudinal Study ◽  
Disease Duration ◽  
Motor Symptom ◽  
Number Of Patients ◽  
Non Motor Symptoms

AbstractSialorrhoea in Parkinson’s disease (PD) is an often neglected yet key non-motor symptom with impact on patient quality of life. However, previous studies have shown a broad range of prevalence figures. To assess prevalence of drooling in PD and its relationship to quality of life, we performed a retrospective analysis of 728 consecutive PD patients who had a baseline and follow-up assessment as part of the Non-motor International Longitudinal Study (NILS), and for whom drooling presence and severity were available, assessed through the Non-Motor Symptoms Scale (NMSS). In addition, we analysed the prevalence of associated dysphagia through self-reported outcomes. Quality of life was assessed through the PDQ-8 scale. Baseline (disease duration 5.6 years) prevalence of drooling was 37.2% (score ≥ 1 NMSS question 19), and after 3.27 ± 1.74 years follow-up, this was 40.1% (p = 0.17). The prevalence of drooling increased with age (p < 0.001). The severity of drooling, however, did not change (p = 0.12). While in 456 patients without drooling at baseline, only 16% (n = 73) had dysphagia (question 20 of the NMSS), in those with drooling this was 34.3% (p < 0.001). At follow-up, the number of patients with dysphagia had increased, 20.4% with no drooling had dysphagia, and 43.6% with drooling had dysphagia. Both at baseline and follow-up, drooling severity was significantly positively associated with quality of life (PDQ-8; r = 0.199; p < 0.001). In moderately advanced PD patients, subjective drooling occurs in over one-third of patients and was significantly associated with decreased quality of life. Dysphagia occurred significantly more often in patients with drooling.

Retrospective Chart Review of Cryopreserved Amniotic Membrane for Knee Pain

2020 ◽  
Author(s):  
Ruben Berrocal Timmons
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Amniotic Membrane ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Final Analysis ◽  
Mean Values ◽  
Number Of Patients ◽  
The Impact

Objective: Treatment of joint pain with an injection of the amniotic membrane has not been adequately studied. This study retrospectively reviewed Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analgesic usage data from patients treated with the injection of cryopreserved amniotic membrane (CAM) in their knees to determine the impact of treatment on patients’ pain, quality of life, and analgesic usage. Methods: Chart review was conducted on 40 patients. Institutional Review Board (IRB) approval was obtained prior to initiation of the project. The membrane was utilized as per the FDA guidance of 21CFR1271. Retrospective data, including demographics, medical history, pain score, quality of life score, analgesic usage and adverse events, were collected from their medical records for each consenting patient through 6 months after CAM injection. Results: A total of 40 patients were considered in the final analysis. Mean VAS for pain level improved from 7.0 to 2.6 (p<0.001). WOMAC daily activity function score improved from a mean score of 52 to 28 (p<0.001). Opioid and non-steroidal anti-inflammatory drug (NSAID) usage decreased from 97% to 25% (p<0.001). No adverse events were reported. Conclusion: Mean values for VAS and WOMAC scores significantly improved at all time points and the number of patients who used analgesics decreased as compared to baseline. CAM injection into painful knee joints decreases pain, improves physical function, and decreases the use of analgesics in the absence of adverse events.

Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor

Neurology ◽  
2019 ◽  
Vol 93 (24) ◽  
pp. e2284-e2293 ◽  
Author(s):  
Casey H. Halpern ◽  
Veronica Santini ◽  
Nir Lipsman ◽  
Andres M. Lozano ◽  
Michael L. Schwartz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Essential Tremor ◽  
Focused Ultrasound ◽  
Rating Scale ◽  
Prospective Trial ◽  
Postural Tremor ◽  
Hand Tremor

ObjectiveTo test the hypothesis that transcranial magnetic resonance–guided focused ultrasound (tcMRgFUS) thalamotomy is effective, durable, and safe for patients with medication-refractory essential tremor (ET), we assessed clinical outcomes at 3-year follow-up of a controlled multicenter prospective trial.MethodsOutcomes were based on the Clinical Rating Scale for Tremor, including hand combined tremor–motor (scale of 0–32), functional disability (scale of 0–32), and postural tremor (scale of 0–4) scores, and total scores from the Quality of Life in Essential Tremor Questionnaire (scale of 0–100). Scores at 36 months were compared with baseline and at 6 months after treatment to assess for efficacy and durability. Adverse events were also reported.ResultsMeasured scores remained improved from baseline to 36 months (all p < 0.0001). Range of improvement from baseline was 38%–50% in hand tremor, 43%–56% in disability, 50%–75% in postural tremor, and 27%–42% in quality of life. When compared to scores at 6 months, median scores increased for hand tremor (95% confidence interval [CI] 0–2, p = 0.0098) and disability (95% CI 1–4, p = 0.0001). During the third follow-up year, all previously noted adverse events remained mild or moderate, none worsened, 2 resolved, and no new adverse events occurred.ConclusionsResults at 3 years after unilateral tcMRgFUS thalamotomy for ET show continued benefit, and no progressive or delayed complications. Patients may experience mild degradation in some treatment metrics by 3 years, though improvement from baseline remains significant.Clinicaltrials.gov identifierNCT01827904.Classification of evidenceThis study provides Class IV evidence that for patients with severe ET, unilateral tcMRgFUS thalamotomy provides durable benefit after 3 years.

scholarly journals Changes in self-rated health and quality of life among Syrian refugees migrating to Norway: a prospective longitudinal study

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Jasmin Haj-Younes ◽  
Elisabeth Marie Strømme ◽  
Jannicke Igland ◽  
Bernadette Kumar ◽  
Eirik Abildsnes ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Longitudinal Study ◽  
Syrian Refugees ◽  
Prospective Longitudinal Study ◽  
Mean Values ◽  
Self Rated Health ◽  
Prospective Longitudinal ◽  
Over Time

Abstract Background Forced migrants can be exposed to various stressors that can impact their health and wellbeing. How the different stages in the migration process impacts health is however poorly explored. The aim of this study was to examine changes in self-rated health (SRH) and quality of life (QoL) among a cohort of adult Syrian refugees before and after resettlement in Norway. Method We used a prospective longitudinal study design with two assessment points to examine changes in health among adult Syrian resettlement refugees in Lebanon accepted for resettlement in Norway. We gathered baseline data in 2017/2018 in Lebanon and subsequently at follow-up one year after arrival. The main outcomes were good SRH measured by a single validated item and QoL measured by WHOQOL-BREF. We used generalized estimating equations to investigate changes in outcomes over time and incorporated interaction terms in the models to evaluate effect modifications. Results In total, 353 subjects participated in the study. The percentage of participants reporting good SRH showed a non-significant increase from 58 to 63% RR, 95%CI: 1.1 (1.0, 1.2) from baseline to follow-up while mean values of all four QoL domains increased significantly from baseline to follow-up; the physical domain from 13.7 to 15.7 B, 95%CI: 1.9 (1.6, 2.3), the psychological domain from 12.8 to 14.5 B, 95%CI: 1.7 (1.3, 2.0), social relationships from 13.7 to 15.3 B, 95%CI: 1.6 (1.2, 2.0) and the environmental domain from 9.0 to 14.0 5.1 B, 95%CI: (4.7, 5.4). Positive effect modifiers for improvement in SRH and QoL over time include male gender, younger age, low level of social support and illegal status in transit country. Conclusion Our results show that good SRH remain stable while all four QoL domains improve, most pronounced in the environment domain. Understanding the dynamics of migration and health is a fundamental step in reaching health equity.

scholarly journals Safety of Denervation Following Targeted Lung Denervation Therapy for COPD: AIRFLOW-1 Three-year Outcomes

2020 ◽  
Author(s):  
Christophe Pison ◽  
Pallav Shah ◽  
Dirk-Jan Slebos ◽  
Vincent Ninane ◽  
Wim Janssens ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Function ◽  
Adverse Events ◽  
Late Onset ◽  
Open Label ◽  
Serious Adverse Events ◽  
Copd Exacerbations ◽  
Clinical Consequences

Abstract Background: Targeted lung denervation (TLD) is a novel bronchoscopic therapy that disrupts parasympathetic pulmonary nerve input to the lung reducing clinical consequences of cholinergic hyperactivity. The AIRFLOW-1 study assessed safety and TLD dose in patients with moderate-to-severe, symptomatic COPD. This analysis evaluated the long-term impact of TLD on COPD exacerbations, pulmonary function, and quality of life over three years of follow up.Methods: TLD was performed in a prospective, energy-level randomized (29 W vs 32 W power), multicenter study (NCT02058459). Additional patients were enrolled in an open label confirmation phase to confirm improved gastrointestinal safety after procedural modifications. Durability of TLD was evaluated at one, two, and three years post-treatment and assessed through analysis of COPD exacerbations, pulmonary lung function, and quality of life. Results: Three-year follow-up data were available for 73.9% of patients (n=34). The annualized rate of moderate to severe COPD exacerbations remained stable over the duration of the study. Lung function (FEV1, FVC, RV, and TLC) and quality of life (SGRQ-C and CAT) remained stable over three years of follow-up. No new gastrointestinal adverse events and no unexpected serious adverse events were observed. Conclusion: TLD in COPD patients demonstrated a positive safety profile out to three years, with no late-onset serious adverse events related to denervation therapy. Clinical stability in lung function, quality of life, and exacerbations were observed in TLD treated patients over three years of follow up.

scholarly journals Bevacizumab Combined with Corticosteroids Does Not Improve the Clinical Outcome of Nasopharyngeal Carcinoma Patients With Radiation-Induced Brain Necrosis

2021 ◽  
Vol 11 ◽  
Author(s):  
Honghong Li ◽  
Xiaoming Rong ◽  
Weihan Hu ◽  
Yuhua Yang ◽  
Ming Lei ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Nasopharyngeal Carcinoma ◽  
Adverse Events ◽  
Clinical Outcomes ◽  
World Health ◽  
World Health Organization Quality ◽  
Brain Necrosis ◽  
Radiation Induced

ObjectiveOur aim was to compare the clinical outcomes of patients treated with bevacizumab combined with corticosteroids and those with bevacizumab monotherapy from a radiation-induced brain necrosis (RN) registry cohort (NCT03908502).MethodsWe utilized clinical data from a prospective RN registry cohort (NCT03908502) from July 2017 to June 2020. Patients were considered eligible if they had symptomatic RN after radiotherapy for nasopharyngeal carcinoma (NPC) and received bevacizumab (5 mg/kg, two to four cycles) with a minimum follow-up time of 3 months. The primary outcome was a 2-month response rate determined by MRI and clinical symptoms. Secondary outcomes included quality of life [evaluated by the abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire] and cognitive function (evaluated by the Montreal Cognitive Assessment scale) at 2 months, RN recurrence during follow-up, and adverse events.ResultsA total of 123 patients (34 in the combined therapy group and 89 in the monotherapy group) were enrolled in our study with a median follow-up time of 0.97 year [interquartile range (IQR) = 0.35–2.60 years]. The clinical efficacy of RN did not differ significantly between patients in these two groups [odds ratio (OR) = 1.642, 95%CI = 0.584–4.614, p = 0.347]. Furthermore, bevacizumab combined with corticosteroids did not reduce recurrence compared with bevacizumab monotherapy [hazard ratio (HR) = 1.329, 95%CI = 0.849–2.079, p = 0.213]. The most common adverse events of bevacizumab were hypertension (17.89%), followed by nosebleed (8.13%) and fatigue (8.13%). There was no difference in grade 2 or more severe adverse events between the two groups (p = 0.811).InterpretationOur results showed that the treatment strategy of combining bevacizumab with corticosteroids did not lead to better clinical outcomes for RN patients with a background of radiotherapy for nasopharyngeal carcinoma.

scholarly journals Bilateral Subthalamic Nucleus Deep Brain Stimulation for Refractory Isolated Cervical Dystonia

2022 ◽  
Author(s):  
Feng Yin ◽  
Mingming Zhao ◽  
Xin Yan ◽  
Tong Li ◽  
Hui Chen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Deep Brain Stimulation ◽  
Adverse Events ◽  
Brain Stimulation ◽  
Short And Long Term ◽  
Stn Dbs ◽  
Deep Brain

Abstract Subthalamic nucleus (STN) deep brain stimulation (DBS) has been proven to be an alternative target choice for refractory isolated cervical dystonia (CD). However, assessments of its short and long-term safety, efficacy, and sustained effectiveness have been limited to few reports. Here, we evaluated nine consecutive refractory isolated CD patients who underwent bilateral STN DBS and accepted to short and long-term follow-up in this retrospective study. Seven time points were used to see the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores (pre-operation [baseline], 1, 3, 6, 12, 24 months post-operation and last follow-up) to assess improvement of dystonic symptoms. The 36-item Short-Form General Health Survey (SF-36) scores obtained at pre-operation and last follow-up to assess the changes in quality of life. All patients tolerated surgery well and acquired observable clinical benefits from STN DBS therapy. All patients achieved a considerable improvement in quality of life at the last follow-up. The hardware-related adverse events can be tolerated and the stimulation-related adverse events can be ameliorated by programming. Our data support the idea that bilateral STN DBS is a safety and effective method for the treatment of refractory isolated CD, with persistent and remarkable improvement in both movement and quality of life.

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