Effectiveness and Safety of Measures to Prevent Infections and Other Complications Associated With Peripheral Intravenous Catheters: A Systematic Review and Meta-analysis.

BACKGROUND: Peripheral intravenous catheters (PIVCs) contribute substantially to the global burden of infections. This systematic review assessed 24 infection prevention and control (IPC) interventions to prevent PIVC-associated infections and other complications. METHODS: We searched Ovid MEDLINE, Embase, Cochrane Library, WHO Global Index Medicus, CINAHL, and reference lists for controlled studies from 1 January 1980-16 March 2023. We dually selected studies, assessed risk of bias, extracted data, and rated the certainty of evidence (COE). For outcomes with 3 or more trials, we conducted Bayesian random-effects meta-analyses. RESULTS: 105 studies met our prespecified eligibility criteria, addressing 16 of the 24 research questions; no studies were identified for 8 research questions. Based on findings of low to high COE, wearing gloves reduced the risk of overall adverse events related to insertion compared with no gloves (1 non-randomized controlled trial [non-RCT]; adjusted risk ratio [RR], .52; 95% CI, .33-.85), and catheter removal based on defined schedules potentially resulted in a lower phlebitis/thrombophlebitis incidence (10 RCTs; RR, 0.74, 95% credible interval, .49-1.01) compared with clinically indicated removal in adults. In neonates, chlorhexidine reduced the phlebitis score compared with non-chlorhexidine-containing disinfection (1 RCT; 0.14 vs 0.68; P = .003). No statistically significant differences were found for other measures. CONCLUSIONS: Despite their frequent use and concern about PIVC-associated complications, this review underscores the urgent need for more high-quality studies on effective IPC methods regarding safe PIVC management. In the absence of valid evidence, adherence to standard precaution measures and documentation remain the most important principles to curb PIVC complications. CLINICAL TRIALS REGISTRATION: The protocol was registered in the Open Science Framework (https://osf.io/exdb4).

Pharmacovigilance practice among pediatric neurologists from Poland and Germany.

OBJECTIVES: To compare the pediatric neurologists' knowledge, practice, and barriers to the pharmacovigilance (PV) process in Poland and Germany. METHODS: The research tool was an online anonymous questionnaire on Google Forms e-mailed to pediatric neurologists from Poland and Germany. RESULTS: The questionnaires were handed out to 830 pediatric neurologists and 371 expressed their consent to participate in the study. Most of the neurologists were familiar with the definition of PV and adverse drug reactions (ADRs). Only 34.10% of pediatric neurologists from Poland, and 38.88% from Germany believe that many ADRs are preventable and almost most of them believe it is necessary to report ADRs from children with epilepsy. Unfortunately, in opposite to this knowledge, only 37.79% of respondents from Poland and 40.32% from Germany felt co-responsible for reporting ADRs. The main reason for the neurologists not to report ADRs was a conviction that reporting ADRs would be an additional burden generating extra work. CONCLUSION: There is no big difference between the practice of PV by pediatric neurologists in Poland and Germany. System-regulated PV stabilization in the country translates into the practice of maintaining PV. Monitoring the safety of pharmacotherapy and knowledge of risks associated with ADRs should be included in the curricula of academic neurologics courses.

Epilepsy is a chronic disorder characterized by episodic, gratuitous seizures. Most children with epilepsy (CWE) rely on antiepileptic drugs causing adverse drug reactions (ADRs). Many ADRs are preventable if physicians actively participate in pharmacovigilance (PV), which its pivotal role is to ensure the safety of pharmacotherapy by e.g. permanent control of ADRs. The study aimed to compare the pediatric neurologists' (PN) knowledge, practice, and barriers to the PV process in Poland and Germany. The research tool was an online anonymous questionnaire on Google Forms e-mailed to PN from Poland and Germany. Only 34.10% of PN from Poland and 38.88% from Germany believe that many ADRs are preventable and almost most of them believe it is necessary to report ADRs from CWE. Unfortunately, in opposite to this knowledge, only 37.79% of respondents from Poland and 40.32% from Germany felt co-responsible for reporting ADRs. The main reason for the neurologists not to report ADRs was a conviction that reporting ADRs would be an additional burden generating extra work. There is no big difference between the practice of PV by PN in Poland and Germany. System-regulated PV stabilization in the country translates into the practice of maintaining PV.

Impact of patient knowledge on hypertension treatment adherence and efficacy: A single-centre study in Poland.

Introduction: Recent studies show that treatment of arterial hypertension is unsuccessful. This is due to the patients' insufficient knowledge of about the therapeutic methods and the consequences of not treating arterial hypertension. Objectives: The aim of the study was to evaluate the patients' knowledge concerning therapeutic options, prophylaxis, and complications of arterial hypertension. The study also assessed the effect of such knowledge on hypertension treatment adherence and efficacy. Patients and Methods: The survey included 488 patients (250 female and 238 male), aged over 18 years, diagnosed with and treated in outpatient and inpatient settings at selected healthcare institutions in Poland. A custom-made questionnaire, based on references on this subject, was the key tool in the present study. Information about the course of the disease and evaluation of hypertension treatment efficacy was based on the patients' medical records. Results: The study found that 54.7% of the subjects had good knowledge about arterial hypertension, 40.0% had average knowledge, and 5.3% had poor knowledge. The extent of knowledge about the disease was significantly dependent on the level of education and the place of receiving medical care (p< 0.05). Good knowledge was significantly associated with controlled blood pressure, number of antihypertensive drugs used, frequency of hospitalization, as well as with medication adherence, and healthy lifestyle behaviours (p< 0.05). Conclusions: More than half of the patients presented good knowledge but a large group still had poor knowledge, especially patients with a low level of education and with hypertension treated at a general practitioner's clinic. The results of our study clearly show that knowledge about arterial hypertension affects medication adherence and healthy lifestyle behaviours and improves hypertension treatment efficacy.

A survey of pharmacists' knowledge, attitudes and barriers in pharmaceutical care concept in Poland.

BACKGROUND: The major goals of pharmaceutical care (PC) are to improve the patient's quality of life and ensure safety of pharmacotherapy. Inclusion of a pharmacist in the multidisciplinary team caring for the patient and integration of state-of-the-art pharmaceutical services with medical care and nursing are some of the most important challenges that the health care system in Poland is facing. OBJECTIVES: To evaluate the pharmacists attitudes towards practice in, and knowledge of PC in Poland and to identify the barriers in PC provision. METHODS: The study was designed as a multicenter study, conducted among Polish pharmacists. Random sampling technique was employed to select the study group. Face-to-face questionnaire method was used to interview the pharmacists, upon obtaining their prior verbal consent to participate in the study. The study was conducted between January 2017 and September 2019. RESULTS: Only 15% of the pharmacists have ever attended a training on PC. 72% believed PC provision was necessary to ensure pharmacotherapy safety. Only 63% of the pharmacists believed that preventing and solving health-related and drug therapy problems for patients were their responsibilities. The main reason for non-provision of PC by the pharmacists was the lack of time for such activities, lack of legal regulations, lack of organizational facilities. CONCLUSION: This study indicates that implementation of PC is expected in Poland. Educational programs in this respect are urgently needed. PC provision should be included in the curricula of academic pharmaceutical courses.

How current biologic therapies affect the risk of major adverse cardiovascular events in patients with plaque psoriasis? A systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION: Concerns have been raised about an increased risk of major adverse cardiovascular events (MACEs) - stroke, myocardial infarction and sudden cardiac death - in patients with plaque psoriasis receiving biologic therapies. AIM: This review and meta-analysis of randomized controlled trials (RCTs) was to evaluate the risk difference of MACEs between experimental and comparator interventions. MATERIAL AND METHODS: We searched MEDLINE database for suitable trials. Prior to that we identified the search strategy and eligibility criteria. Each RCT was double-blind, placebo controlled and scored five points in Jadad scale. We calculated risk difference (RD) with use of the Mantel-Haenszel fixed-effect method with 95% confidence intervals (CIs) and calculated i2 statistic to assess heterogeneity. A total of 43 RCTs were included, involving 19,161 patients. Overall, the risk of MACEs in the included studies was 0.1% (n = 21). RESULTS: There were no statistically significant risk differences in patients treated with biologic therapy vs. placebo (RD = 0.0; Z = 1.09; 95% CI: 0.0-0.0; p = 0.28); tumour necrosis inhibitors vs. placebo (RD = 0.0; Z = 0.47; 95% CI: -0.0-0.0; p = 0.64); anti-IL-17A agents vs. placebo (RD = 0.0; Z = 1.25; 95% CI: -0.0-0.01; p = 0.21); anti-IL-23 agents vs. placebo (RD = 0; Z = 0.36; 95% CI: -0.0-0.01; p = 0.72); anti-IL-12/23 agents vs. placebo (RD = 0.0; Z = 0.73; 95% CI: -0.0-0.0; p = 0.46). CONCLUSIONS: Further trials are needed, including longer follow-up and patients with an increased cardiovascular risk, to assess the risk of MACEs.

Safety of medicines-Pharmacists' knowledge, practice, and attitudes toward pharmacovigilance and adverse drug reactions reporting process.

PURPOSE: Patients' safety is a public concern in healthcare systems across the world and should be ensured, among others, by pharmacovigilance based on spontaneous reports of adverse drug reactions (ADRs). Spontaneous ADRs reporting is an important component of the pharmacovigilance system. The role of pharmacists in spontaneous ADRs reporting is crucial in the pharmacovigilance system since it helps to monitor the patients' treatment in real-life conditions. The aim of the study was to evaluate the pharmacists' attitudes to and knowledge on spontaneous ADRs reporting in Poland and to identify the reasons for underreporting of ADRs. METHODS: The study was conducted between January 2016 and January 2018. A self-administered questionnaire was designed and distributed to pharmacists. The pharmacists were randomly selected from the official database kept by the chief pharmaceutical inspectorate in Poland. RESULTS: Only 16% (n = 84) of the respondents have ever attended a training on pharmacovigilance. Eighty-one percent (N = 422) of pharmacists believe that not all synthetic drugs available on the market were safe. Twenty-eight percent (n = 146) of the respondents were certain about safety of drugs of natural origin, and 16% (n = 84) were of an opinion that adverse reactions following administration of such drugs should not be reported at all. CONCLUSIONS: To conclude, there is an increasing awareness of the need to develop pharmacovigilance practices. The current (not fully adhered to in practice) model of pharmacovigilance and its associated tools have been developed for synthetic drugs, and applying these methods to monitor safety of herbal medicines presents unique challenges.

Evaluation of the antidepressant, anxiolytic and memory-improving efficacy of aripiprazole and fluoxetine in ethanol-treated rats.

Some study results indicate a positive effect of aripiprazole (ARI) on impaired cognitive functions caused by brain damage resulting from chronic EtOH abuse. However, other research shows that to manifest itself, an ARI antidepressant effect requires a combined therapy with another selective serotonin reuptake inhibitor antidepressant, namely, fluoxetine (FLX). The aim of this article was to assess antidepressant and anxiolytic effects of ARI as well as its effect on spatial memory in ethanol-treated (alcoholized) rats. On the basis of alcohol consumption pattern, groups of (1) ethanol-preferring rats, with mean ethanol intake above 50%, and (2) ethanol-nonpreferring rats (EtNPRs), with mean ethanol intake below 50% of total daily fluid intake, were formed. The group of EtNPRs was used for this study, subdivided further into three groups administered ARI, FLX and a combination of both, respectively. Behavioral tests such as Porsolt's forced swimming test, the Morris water maze test and the two-compartment exploratory test were employed. Behavioral test results demonstrated (1) no antidepressant effect of ARI in EtNPRs in subchronic treatment and (2) no procognitive effect of ARI and FLX in EtNPRs in combined single administration. Combined administration of both drugs led to an anxiogenic effect and spatial memory deterioration in study animals. ARI had no antidepressant effect and failed to improve spatial memory in rats. However, potential antidepressant, anxiolytic and procognitive properties of the drug resulting from its mechanism of action encourage further research aimed at developing a dose of both ARI and FLX that will prove such effects in alcoholized EtNPRs.

Evaluation of antidepressant and memory-improving efficacy of aripiprazole and fluoxetine in alcohol-preferring rats.

INTRODUCTION AND AIMS: Dependence on ethanol increases the risk of depression in patients and leads to a damage and deficiencies of brain function, which manifest in cognitive functions impairment. Aripiprazole (ARI) is an atypical antipsychotic drug, which has also been shown to have a beneficial effect on cognitive function. Results of many studies show that, for ARI's antidepressant effect to manifest itself, it is necessary to use a combined therapy with a drug from the group of selective serotonin reuptake inhibitors (SSRIs). The aim of this paper was to assess the antidepressant and impact of ARI on spatial memory in alcohol-preferring rats (EtNPRs). DESIGN AND METHODS: In our study, we used Porsolt's forced swimming test (antidepressant effect) and Morris water maze test. The tests have been conducted upon administration of ARI (6 mg/kg i.p.), fluoxetine (FLX; 5 mg/kg p.o.) and combined administration of both drugs in alcohol-dependent rats. RESULTS: The results of behavioural tests carried out have shown a lack of antidepressant and procognitive effects of either ARI or FLX in EtPRs after acute and chronic treatment. Combined administration of both drugs would lead to spatial memory deterioration in the study animals. DISCUSSION AND CONCLUSIONS: Our results suggest that ARI applied in the experiment had no antidepressant effect and failed to improve spatial memory in study rats. Potential antidepressant and procognitive properties of this drug resulting from its mechanism of action encourage attempts (design) of further research aimed at developing a dose, which will show such effects in alcohol-preferring animals.

Clinical Factors Affecting Survival in Patients with Congenitally Corrected Transposition of the Great Arteries: A Systematic Review and Meta-Analysis.

Background: Congenitally corrected transposition of the great arteries (cc-TGA) is a defect characterized by arterio-ventricular and atrioventricular disconcordance. Most patients have co-existing cardiac abnormalities that warrant further treatment. Some patients do not require surgical intervention, but most undergo physiological repair or anatomical surgery, which enables them to reach adulthood. Aims: We aimed to evaluate mortality risk factors in patients with cc-TGA. Results: We searched the PubMed database and included 10 retrospective cohort studies with at least a 5-year follow-up time with an end-point of cardiovascular death a minimum of 30 days after surgery. We enrolled 532 patients, and 83 met the end-point of cardiovascular death or equivalent event. As a risk factor for long-term mortality, we identified New York Heart Association (NYHA) class ≥III/heart failure hospitalization (OR = 10.53; 95% CI, 3.17-34.98) and systemic ventricle dysfunction (SVD; OR = 4.95; 95% CI, 2.55-9.64). We did not show history of supraventricular arrhythmia (OR = 2.78; 95% CI, 0.94-8.24), systemic valve regurgitation ≥moderate (SVR; OR = 4.02; 95% Cl, 0.84-19.18), and pacemaker implantation (OR = 1.48; 95% Cl, 0.12-18.82) to affect the long-term survival. In operated patients only, SVD (OR = 4.69; 95% CI, 2.06-10.71) and SVR (OR = 3.85; 95% CI, 1.5-9.85) showed a statistically significant impact on survival. Conclusions: The risk factors for long-term mortality for the entire cc-TGA population are NYHA class ≥III/heart failure hospitalization and systemic ventricle dysfunction. In operated patients, systemic ventricle dysfunction and at least moderate systemic valve regurgitation were found to affect survival.

Comparative Efficacy of Animal Depression Models and Antidepressant Treatment: A Systematic Review and Meta-Analysis.

BACKGROUND: Animal models are critical tools in the study of psychiatric disorders; however, none of the current models fully reflect human stress-related disorders, even though most of the knowledge about the mechanisms of depression comes from animal studies. Animal studies are useful in pharmacological research, whereby we can obtain results that translate into patient treatment by controlling environmental factors, especially in behavioural research. The authors systematically reviewed this issue since medical databases provide access to many primary studies. METHODS: A systematic review and meta-analysis were conducted based on 25 primary studies. The studies were identified in databases such as PubMed, Embase, and Web of Science (December 2022) according to the inclusion and exclusion criteria established at the beginning of the research and published in the form of a protocol, following the PRISMA and Cochrane Collaboration methodology for secondary studies and CAMARADES (CAMARADES Berlin, QUEST-BIH Charité) for secondary studies on animals. Forest plot analyses were performed (data presented as Mean Difference, Random Model, Inverse Variance), Risk of Bias assessment (Systematic Review Center for Laboratory animal Experimentation (SYRCLE) evaluation), quality assessment of included studies (Animal research: Reporting of In Vivo Experiments (ARRIVE)), and a range of data from source publications were compiled in tabular form. The study analysed the popularity of both animal depression models (ADM) and rat strains used in pharmacological research to test the efficacy of antidepressant drugs based on the immobility time (IT) factor (Forced Swimming Test). The study examined selective serotonin reuptake inhibitors, namely fluoxetine, sertraline, paroxetine, citalopram, and escitalopram. Additionally, the study addressed issues concerning the "data availability statement" because precise IT data analysis was impossible in the case of 212 papers. RESULTS: Our data confirm that the Chronic Unpredictable Mild Stress (CUMS) model is the most popular and versatile model used in preclinical depression research, while the two most popular rat strains were Wistar and Sprague-Dawley. The quality of included papers based on the ARRIVE assessment showed a ratio value equal to 0.63, meaning that studies were of intermediate overall quality. The Risk of Bias assessment based on the SYRCLE tool revealed a high risk related to the blinding and the random outcome assessment. In the meta-analysis, the results indicate that all analysed drugs demonstrated efficacy in reducing IT, and the most analysed drug was fluoxetine (confirmed based on 17 studies (19 models)). The analysis of the efficacy of ADMs showed that the most effective models were CUMS, Flinders Sensitive Line (genetic model), Social Isolation, Restraint Stress, and Low-dose Lipopolysaccharide (pharmacological model). Only 2.35% (5 out of 212) of corresponding authors responded to our data request. CONCLUSIONS: The study highlights the dominance of the CUMS model and the Wistar and Sprague-Dawley rat strains in preclinical depression research, affirming the efficacy of SSRIs, particularly fluoxetine, in reducing IT. The findings underscore the need for better data availability and methodological improvements despite intermediate overall study quality and notable bias risks. Enhanced transparency and rigorous assessment standards are essential for advancing the reliability of animal models in depression research.