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Evaluation of the safety of medication-use systems in hospital emergency services
No full text20.500.12530/87910Introduction: The aim of this study was to assess the implementation of safe medication practices in hospital emergency services, in order to understand the points of greatest risk as well as the safety challenges faced by these departments, and to plan collaboratively improvement initiatives. Method: Multicentric and descriptive study based on completion of the "Medication safety self-assessment of emergency services" from 5/16/2023 to 11/16/2023, at voluntarily participating emergency services. The survey contained 93 items grouped into 10 key elements. Mean score and mean percentages based on the maximum possible values for the overall survey, for the key elements and for each individual item of evaluation, were assessed. Results: A total of 72 emergency services completed the questionnaire. The mean score obtained for the overall questionnaire was 428.3 points (51.1% of the maximum score). Results showed a large variation among the scores of the participating services (range: 164-620.5). Four key elements had values below 50%, corresponding to competence and training of professionals in safety practices (38.4%); incorporation of pharmacists in emergency departments (42.1%), availability and accessibility of information about patients (43.1%), and patient education (48.1%). The highest values corresponded to labeling, packaging, and naming of medications (69.2%) and communication of prescriptions and other medication information (64%). No differences were found between emergency services in the key elements according to the dependency or size of the hospital, or the type of service, except for the item referring to the incorporation of pharmacists in the emergency service, where differences were observed between hospitals with less than 200 beds (28.9%) and those with more than 500 (52.2%). Conclusion: The application of the specific self-assessment questionnaire has made it possible to identify safety practices that are insufficiently implemented into emergency services in our country and to identify critical points for improvement for which planning collaborative initiatives to reduce medication errors in these departments should become a priority. (c) 2024 Sociedad Espa & ntilde;ola de Farmacia Hospitalaria (S.E.F.H). Published by Elsevier Espa & ntilde;a, S.L.U. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
Real-world evaluation of the effectiveness and safety of dupilumab in bullous pemphigoid: an ambispective multicentre case series.
No full text20.500.12530/87858Bullous pemphigoid (BP) affects elderly individuals with multiple comorbidities, making conventional treatments unsuitable. Evaluate the effectiveness and safety of dupilumab in the treatment of BP. A multicentre ambispective cohort study was conducted across 34 hospitals. Patients with BP treated with dupilumab were included. Most of the patients (97.1%) received an initial 600-mg dose followed by 300 mg every 2 weeks. The primary outcome was the proportion of patients achieving complete remission (CR) within 4 weeks, defined as an Investigator's Global Assessment score of 0 or 1. CR at weeks 16, 24 and 52, adverse events (AEs), reductions in Peak Pruritus Numerical Rating Scale (PP-NRS) and systemic glucocorticoid use were also assessed. The study included 103 patients with a median age of 77.3 years; 58.3% were male. CR was achieved by 53.4% within 4 weeks and 95.7% by week 52. The PP-NRS score reduced by 70.0% by week 4 and was completely controlled by week 24. Thirteen patients presented with AEs, most of which were mild. Systemic glucocorticoid use reduced by 82.1% by week 52. Shorter disease duration and exclusive cutaneous involvement predicted better response at 16 weeks. No differences in response rates to dupilumab were observed between drug-associated BP and idiopathic cases. No significant difference in response rates was observed between patients treated with dupilumab in monotherapy and those receiving dupilumab with concomitant treatments. Dupilumab is effective, rapid and safe in managing BP, reducing the need for corticosteroids and other treatments. Early initiation and exclusive skin involvement predict better outcomes
Systematic literature review and meta-analysis of health state utility values in metastatic castration-resistant prostate cancer.
No full textDespite being an important goal, the preservation of quality of life of patients with metastatic castration-resistant prostate cancer (mCRPC) is poorly characterized across lines of therapy. In this review, a systematic literature review and meta-analysis were conducted to synthesize EuroQoL 5-Dimension (EQ-5D) data among adult men with asymptomatic or mildly symptomatic mCRPC in both first line (1L) and second line and later (2L+) therapy. MEDLINE, Embase, and Cochrane CENTRAL were searched from inception to October 2022 using Ovid. Supplemental searches of other data sources were also conducted (PROSPERO registration: CRD42021283512). Meta-analyses were conducted to estimate pooled EQ-5D index utility values and EQ visual analog scale (VAS) scores in both 1L and 2L+. Various sensitivity analyses were also conducted. Forty-five unique publications met the inclusion criteria. In primary studies, baseline EQ-5D index utility values ranged from 0.7 to 0.9 in 1L and 0.63 to 0.7 in 2L+. Twelve trials and observational studies were feasible for inclusion in the meta-analysis. The pooled mean baseline EQ-5D index utility value was estimated as 0.79 (95% CI, 0.70-0.84) and 0.69 (95% CI, 0.67-0.71) for 1L (n = 7 studies) and 2L + (n = 4 studies), respectively. The pooled mean baseline EQ VAS score was estimated as 74.63 (95% CI, 70.97-78.29) and 65.82 (95% CI, 64.53-67.11) in 1L and 2L+, respectively. Limitations include hampered comparability between studies due to heterogeneity in study design and geographical regions. This study provides a comprehensive synthesis of EQ-5D data presently available in adults with mCRPC in both 1L and 2L + therapy
Validation of an IMU-Based Gait Analysis Method for Assessment of Fall Risk Against Traditional Methods.
No full text20.500.12530/87871Falls are a severe problem in older adults, often resulting in severe consequences such as injuries or loss of consciousness. It is crucial to screen fall risk in order to prescribe appropriate therapies that can potentially prevent falls. Identifying individuals who have experienced falls in the past, commonly known as fallers, is used to evaluate fall risk, as a prior fall indicates a higher likelihood of future falls. The methods that have the most support from evidence are Gait Speed (GS) and Time Up and Go (TUG), which use specific cut-off values to evaluate the fall risk. There have been proposals for alternative methods that use wearable sensor technology to improve fall risk assessment. Although these technological alternatives are promising, further research is necessary to validate their use in clinical settings. In this study, we propose a method for identifying fallers based on a Support Vector Machine (SVM) classifier. The inputs for the classifier are the gait parameters obtained from a 30-minute walk recorded using an Inertial Measurement Unit (IMU) placed at the foot of patients. We validated our proposed method using a sample of 157 patients aged over 70 years. Our findings indicate significant differences (
Hypokalaemia in patients with type 2 diabetes and chronic kidney disease: the effect of finerenone-a FIDELITY analysis.
No full textHypokalaemia is associated with cardiovascular events and mortality in patients with chronic kidney disease (CKD). This exploratory FIDELITY analysis, a prespecified pooled patient-dataset from FIDELIO-DKD and FIGARO-DKD, investigated the incidence and effect of hypokalaemia in patients with CKD and type 2 diabetes (T2D) treated with finerenone vs. placebo. Outcomes include the incidence of treatment-emergent hypokalaemia (serum potassium A substantial proportion of patients with CKD and T2D experienced hypokalaemia, which was associated with an increased hazard of adverse cardiovascular outcomes. Finerenone reduced the incidence of hypokalaemia. Finerenone reduced the hazard of cardiovascular and arrhythmia outcomes irrespective of serum potassium subgroups. Clinical trials registration: FIDELIO-DKD and FIGARO-DKD are registered with ClinicalTrials.gov, numbers NCT02540993 and NCT02545049, respectively (funded by Bayer AG)
No Impact of HIV Coinfection on Mortality in Patients With Hepatitis C Virus Infection After Sustained Virological Response.
No full textIn patients with hepatitis C virus (HCV) chronic infection and advanced liver disease, the impact of human immunodeficiency virus (HIV) coinfection on the clinical outcome after sustained virological response (SVR) has not been sufficiently clarified. The aim of this study was to compare the mortality after SVR of patients bearing HCV chronic infection and advanced liver fibrosis, with and without HIV coinfection after a prolonged follow-up. This was a prospective multicenter cohort study including individuals with HIV/HCV coinfection and patients with HCV monoinfection from Spain, fulfilling (1) liver stiffness (LS) ≥9.5 kPa before treatment, (2) SVR with a direct-acting antiviral-based regimen, and (3) LS measurement available at SVR. The main outcome was overall survival. Mortality attributable to liver disease and nonhepatic causes was also assessed. A total of 1118 patients were included, of whom 676 (60.5%) had HIV. The median (Q1-Q3) follow-up was 76 (57-83) months. After SVR, 46 (10%) HCV-monoinfected and 74 (11%) HIV/HCV-coinfected patients died. The overall mortality rate (95% CI) was 1.9 (1.6-2.2) per 100 person-years, 1.9 (1.4-2.5) per 100 person-years in patients with HCV monoinfection, and 1.8 (1.6-2.3) per 100 person-years in people with HIV. In the multivariable analysis, HIV coinfection was not associated with shorter survival (hazard ratio, .98; 95% CI, .61-1.58; P = .939). In patients with HCV chronic infection and advanced fibrosis, HIV coinfection does not reduce the overall survival after SVR. Clinicaltrials.gov (NCT04460157)
Early Detection of Cancer and Precancerous Lesions in Persons With HIV Through a Comprehensive Cancer Screening Protocol.
No full text20.500.12530/87858Non-AIDS defining malignancies present a growing challenge for persons with human immunodeficiency virus (HIV, PWH), yet tailored interventions for timely cancer diagnosis are lacking. The Spanish IMPAC-Neo protocol was designed to compare two comprehensive cancer screening strategies integrated into routine HIV care. This study reports baseline data on the prevalence and types of precancerous lesions and early-stage cancer among participants at enrolment. Acceptability of the procedure was additionally assessed. Cross-sectional analysis of a comprehensive screening protocol to detect precancer and cancer. The readiness of healthcare providers to implement the protocol was evaluated using a validated 4-item survey. Among the 1430 enrolled PWH, 1172 underwent 3181 screening tests, with positive findings in 29.4% of cases, leading to further investigation in 20.7%. Adherence to the protocol was 84%, with HIV providers expressing high acceptability (97.1%), appropriateness (91.4%), and feasibility (77.1%). A total of 145 lesions were identified in 109 participants, including 60 precancerous lesions in 35 patients (3.0%), 9 early-stage cancers in 9 patients (0.8%), and 76 low-risk lesions in 65 subjects (5.5%). Adverse events related to screening occurred in 0.8% of participants, all mild. The overall prevalence of cancer precursors or early-stage cancer was 3.8% (95% confidence interval [CI], 2.74%-5.01%), with highest rates observed in individuals screened for anal and colorectal cancers. The baseline comprehensive cancer screening protocol of the IMPAC-Neo study successfully identified a significant proportion of PWH with precancerous lesions and early-stage cancer. High adherence rates and positive feedback from providers suggest effective implementation potential in real-world healthcare settings
Polygenic and Polyenvironment Interplay in Schizophrenia-Spectrum Disorder and Affective Psychosis; the EUGEI First Episode Study.
No full text20.500.12530/87858Multiple genetic and environmental risk factors play a role in the development of both schizophrenia-spectrum disorders and affective psychoses. How they act in combination is yet to be clarified. We analyzed 573 first episode psychosis cases and 1005 controls, of European ancestry. Firstly, we tested whether the association of polygenic risk scores for schizophrenia, bipolar disorder, and depression (PRS-SZ, PRS-BD, and PRS-D) with schizophrenia-spectrum disorder and affective psychosis differed when participants were stratified by exposure to specific environmental factors. Secondly, regression models including each PRS and polyenvironmental measures, including migration, paternal age, childhood adversity and frequent cannabis use, were run to test potential polygenic by polyenvironment interactions. In schizophrenia-spectrum disorder vs controls comparison, PRS-SZ was the strongest genetic predictor, having a nominally larger effect in nonexposed to strong environmental factors such as frequent cannabis use (unexposed vs exposed OR 2.43 and 1.35, respectively) and childhood adversity (3.04 vs 1.74). In affective psychosis vs controls, the relative contribution of PRS-D appeared to be stronger in those exposed to environmental risk. No evidence of interaction was found between any PRS with polyenvironmental score. Our study supports an independent role of genetic liability and polyenvironmental risk for psychosis, consistent with the liability threshold model. Whereas schizophrenia-spectrum disorders seem to be mostly associated with polygenic risk for schizophrenia, having an additive effect with well-replicated environmental factors, affective psychosis seems to be a product of cumulative environmental insults alongside a higher genetic liability for affective disorders
Early monitoring of anti-infliximab antibodies by drug-tolerant assay predicts later immunogenicity and drug survival in rheumatic diseases.
No full text20.500.12530/87913To investigate the appearance of anti-drug antibodies (ADA) against infliximab (IFX) determined by drug-sensitive and drug-tolerant assays and their relationship with drug levels and drug survival. This longitudinal observational study included 45 patients with RA and 61 with SpA. Serum samples were obtained at weeks 2, 6, 12, 24 and 52. Serum IFX levels were measured by a capture ELISA and ADA by an in-house drug-sensitive two-site (bridging) ELISA (bELISA) and a commercially available drug-tolerant ELISA (IDK, Immundiagnostik, Germany). ADA were detected earlier by IDK than by bELISA. Once ADA appeared, positivity persisted throughout the study period. Patients who were bELISA ADA+ had higher IDK ADA levels (than bELISA ADA- patients). Circulating IFX levels were detected in all patients except those found to be bELISA ADA+. Serum IFX levels were lower in IDK ADA+ than in IDK ADA- patients. Most patients (64%) discontinued due to inefficacy. The early onset of immunogenicity was related to IFX survival. In both RA and SpA, the median survival (years) was shorter in patients with earlier development of ADA (IDK+ before or at week 24) than those who became IDK+ later (after week 24) or never developed ADA. A drug-tolerant assay detects ADA during IFX therapy earlier and more frequently than a drug-sensitive assay. The onset of immunogenicity detected by drug-tolerant assays is related to the subsequent detection of ADA by drug-sensitive assays and drug survival
Cost-effectiveness of preoperative pharmaceutical care consultations: a 5-year analysis.
No full text20.500.12530/87910Preoperative medication errors can be prevented by screening patients through a preoperative pharmaceutical care consultation. The aim of this study was to analyse the cost-effectiveness of implementing such a consultation and to determine which patients would benefit most. A retrospective study was conducted that included all patients who underwent a preoperative pharmacy consultation between 2016 and 2020. During this consultation, two part-time pharmacists reviewed patients' appropriate preoperative chronic medication management. All prevented errors were collected and classified by therapeutic group and type of error. A team of pharmacists and anaesthetists assigned to each prevented medication error a probability of causing an adverse event 'p', following the methodology of Nesbit et al by establishing five different 'p' values: 0, 0.01, 0.1, 0.4, and 0.6. 'p' = 1 was not considered. The cost of an adverse event was determined to be between €4124 and €6946 according to current literature, and a sensitivity analysis was performed by increasing the interval by 20% above and below. The cost of employing two part-time specialist pharmacists was estimated to be €59 142. Savings per medication error prevented were calculated as (€4124 OR €6946) × 'p'. Total savings were the sum of all costs associated with prevented medication errors. Patients on chronic medications who were in therapeutic groups with a 0.6 probability of an adverse event or who were in therapeutic groups responsible for 50% of the prevented adverse events were considered prioritisable. 3105 patients attended the consultation and 1179 medication errors were prevented, corresponding to 300 adverse events. 42.2% of the errors had a 'p' of 0.4. The costs avoided by this consultation ranged from €1 237 200 to €2 083 800, while the cost of its implementation was €295 710. The cost-effectiveness ratio was between €4.2 and €7.0 saved per euro invested. In the sensitivity analysis, the ratios ranged from €3.3 to €8.5 per euro invested. Fifteen different therapeutic groups accounted for 90% of the medication errors prevented. The therapeutic groups 'Agents acting on the renin-angiotensin system', 'Antidiabetics, non-insulin (excluding SGLT2)' and 'Antithrombotics: low molecular weight heparins' were responsible for 56% of the prevented adverse events. The therapeutic groups 'Antidiabetics: rapid-acting insulin' and 'Antithrombotic agents: vitamin K antagonists, low-molecular-weight heparins, or direct oral anticoagulants' had a 'p' of 0.6. Therefore, patients in six therapeutic groups should be prioritised for preoperative pharmacy counselling. The implementation of preoperative pharmaceutical care consultations in Spain has proven to be cost-effective. Incorporating the probability of a medication error causing an adverse event allowed the prioritisation of patients for these consultations. Patients taking anticoagulants, oral antidiabetics, rapid-acting insulins, and agents acting on the renin-angiotensin system benefited the most. This study could serve as a basis for implementing such consultations in other hospitals, as they are effective in reducing the cost of medication errors in surgical patients