We assessed the effectiveness and safety of vitamin K antagonists (VKAs) versus direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) using artificial intelligence techniques. This is a retrospective study in 15 Spanish hospitals (2014-2020), including adult AF patients with no history of anticoagulation, thrombosis events, rheumatic mitral valvular heart disease, mitral valve stenosis, or pregnancy. We employed EHRead technology based on natural language processing (NLP) and machine learning (ML), along with SNOMED-CT terminology, to extract clinical data from electronic health records (EHRs).
View Article and Find Full Text PDFPurpose: We developed a predictive model to assess the risk of major bleeding (MB) within 6 months of primary venous thromboembolism (VTE) in cancer patients receiving anticoagulant treatment. We also sought to describe the prevalence and incidence of VTE in cancer patients, and to describe clinical characteristics at baseline and bleeding events during follow-up in patients receiving anticoagulants.
Methods: This observational, retrospective, and multicenter study used natural language processing and machine learning (ML), to analyze unstructured clinical data from electronic health records from nine Spanish hospitals between 2014 and 2018.
Objective: To analyse the characteristics and use of digital health tools (DHT) in inflammatory bowel disease (IBD).
Methods: We performed a qualitative study based on a narrative literature review, a questionnaire and on the opinion of 3 expert gastroenterologists. Several searches were carried out until September 2022 through Medline to identify articles on the use of DHT in IBD by healthcare professionals.
Introduction: Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by itchy, painful, and dry skin. Despite the great number of available therapies, economic evaluations are still needed to provide evidence on their cost efficiency. This research aimed to evaluate the cost effectiveness of the Janus kinase (JAK) inhibitor abrocitinib (200 mg) compared with dupilumab (300 mg), tralokinumab (300 mg), baricitinib (2 and 4 mg), and upadacitinib (15 and 30 mg) for the treatment of patients with severe AD from the Spanish National Health System (NHS) perspective.
View Article and Find Full Text PDFObjective: Evaluate the safety profile and tolerability of topical phosphodiesterase 4 (PDE4) inhibitors versus vehicle as treatment for atopic dermatitis in published studies.
Methods: A search was performed in Medline/PubMed, Web of Science, and Cochrane Library databases on September 27, 2021, by 1 evaluator, without restrictions on publication dates or languages. Terms such as , and were included.
Aim: Recent studies have compared the efficacy and safety of direct-acting oral anticoagulants (DOAC) and low-molecular-weight heparin (LMWH) for cancer-associated venous thromboembolism (VTE). However, there is no available cost-effectiveness analysis comparing DOAC and LMWH. The study aimed to conduct a cost-effectiveness analysis of DOAC (apixaban, edoxaban, and rivaroxaban) LMWH for the treatment of cancer-associated VTE in Spain from the Spanish healthcare system perspective.
View Article and Find Full Text PDFIntroduction And Objective: In Spain, vitamin K antagonists (VKA) remain the standard treatment for the prevention of thromboembolic and hemorrhagic complications in patients with atrial fibrillation (AF), despite the high risks of suffering adverse effects. The objective of this study was to characterize the profile of VKA-treated patients suffering from stroke/systemic embolism (SE) or major hemorrhagic episodes, their evolution and the actions taken after those episodes.
Materials And Methods: EVENTHO was an observational multicenter study conducted in 22 Anticoagulation Spanish Units.
Background: overactive bladder (OAB) is a common condition in older persons. Antimuscarinic treatment remains the mainstay of treatment of OAB but clinicians have been reluctant to prescribe this to older patients. This study examined efficacy and safety information from patients >65 in fesoterodine trials to reaffirm efficacy and to explore the relationships between treatment emergent adverse events (TEAEs), coexisting medication and co-morbidity.
View Article and Find Full Text PDFObjective: To describe the profile of the overactive bladder (OAB) patient on treatment with flexible-dose antimuscarinic treatment in daily clinical practice.
Methods: This was an observational, retrospective and multicenter study, carried out at 88 public and private hospitals. Adult patients diagnosed with OAB who initiated flexible-dose antimuscarinic treatment.
Contemp Clin Trials
November 2016
The ability to set realistic expectations of treatment response in patients with overactive bladder (OAB) can have an impact on patient engagement and adherence to study medication. In order to help set treatment expectations for OAB, a Physician Predictive Tool has been developed based on predictive modelling. Models have been developed utilizing data from eight Phase 3 and 4 fesoterodine clinical trials and these models enable the prediction of individual treatment response in subjects with OAB, based on various baseline characteristics.
View Article and Find Full Text PDFObjective: To summarize published evidence on the pharmacology, efficacy, and safety of fesoterodine for the treatment of overactive bladder (OAB) symptoms in relation to patient clinical and demographic profiles.
Methods: A systematic review of published articles on fesoterodine was conducted via a PubMed search. Articles were identified using the search term fesoterodine, with limits of human species and abstract available.
Overactive bladder (OAB) is a common condition, with prevalence rates increasing with advancing age. Symptoms of OAB, including urgency urinary incontinence (UUI), are associated with various co-morbidities in elderly individuals (e.g.
View Article and Find Full Text PDFBackground And Objective: To perform the psychometric validation in the Spanish population of the Overactive Bladder Awareness Tool (OAB-V8) scale and its abbreviated version OAB-V3 for screening patients with probable overactive bladder (OAB).
Patients And Methods: A cross-sectional study was conducted in a population aged over 18 years, which was representative of the prevalence of OAB in Spain using an online methodology (Internet survey). Psychometric properties included feasibility, reliability, and validity.
Aim: To investigate factors which may influence dose escalation of antimuscarinics for overactive bladder (OAB) in older patients and how dose escalation affects treatment efficacy.
Materials And Methods: A post hoc analysis of data from the 12-week randomized, placebo controlled phase of the SOFIA study investigating treatment with fesoterodine in older people with OAB. Predictors and outcomes in patients aged ≥65 years with OAB who did or did not choose to escalate from fesoterodine 4 to 8 mg before the first dose-escalation choice point (week 4) and at the end of the study (week 12) were assessed.
Objective: To determine the course of overactive bladder (OAB) symptoms after 4 weeks of no treatment following a 12-week study of the efficacy and safety of flexible-dose fesoterodine in patients with OAB who were enrolled in the UK healthcare system. There are limited data available on the natural time course of OAB symptoms after the cessation of treatment.
Patients And Methods: In the open-label UK Study Assessing Flexible-dose Fesoterodine in Adults trial, patients aged ≥18 years with self-reported OAB symptoms for ≥3 months, a mean of at least eight micturitions per 24 h and three or more urgency episodes per 24 h on a 3-day bladder diary at baseline, and at least moderate bladder-related problems reported on the Patient Perception of Bladder Condition (PPBC) at baseline, were treated with fesoterodine for 12 weeks.
Introduction And Hypothesis: This work was designed to explore the ability of the self-administered Overactive Bladder 8-Question Awareness Tool (OAB-V8) to predict patient self-assessed effectiveness of antimuscarinic therapy on OAB symptoms in daily practice. Also, the ability of the tool to predict clinician evaluation of improvement was explored.
Methods: Patients of both genders, >18 years, with symptomatic OAB (score >8 on OAB-V8), and able to understand patient-reported outcome instruments were enrolled in this 3-month study.
Background: Previous randomized studies have demonstrated that fesoterodine significantly improves the Overactive Bladder (OAB) symptoms and their assessment by patients compared with tolterodine extended-release (ER). This study aimed to assess the effect of aging and dose escalation on patient-reported treatment benefit, after changing their first Overactive Bladder (OAB) therapy with tolterodine-ER to fesoterodine in daily clinical practice.
Methods: A post-hoc analysis of data from a retrospective, cross-sectional and observational study was performed in a cohort of 748 OAB adults patients (OAB-V8 score ≥8), who switched to fesoterodine from their first tolterodine-ER-based therapy within the 3-4 months before study visit.
Background: Overactive bladder (OAB) is characterized by the symptoms of urinary urgency or urge incontinence, which appear without a local pathological or metabolic explanation. OAB is defined by symptoms and the evaluation of treatment effectiveness should be based upon patient perceptions. The Overactive Bladder Questionnaire-Short Form (OAB-q SF) is a brief, self-administered patient-reported outcomes tool with two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB.
View Article and Find Full Text PDFBackground: Fesoterodine, a new once daily antimuscarinic, has proven to be an effective, safe, and well-tolerated treatment in patients with overactive bladder (OAB). To date, no analysis has evaluated the economic costs and benefits associated with fesoterodine, compared to antimuscarinics in Spain. The purpose of this analysis was to assess the economic value of OAB treatment with fesoterodine relative to extended release tolterodine and solifenacin, from the societal perspective.
View Article and Find Full Text PDFBackground: Despite the growing interest on Urinary Incontinence (UI) in our country, nocturnal enuresis and Overactive Bladder (OAB), there are no epidemiologic studies on the prevalence of these health problems in the different affected groups of the general population.
Patients And Methods: This is an epidemiologic, observational, multicentre and national study. Data were collected by means of personal interviews in 5 representative areas from Spain and in 4 groups of population: 1) working women (25- 64-years-old); 2) working men (50- 64-years-old); 3) children attending primary school (6- 11-years-old); and 4) elderly institutionalized subjects (over 65-years-old) with no mental impairment.