Administration Criteria Research Articles

Safety and efficacy analysis of the off-label use of pipeline embolization devices for intracranial aneurysms: a propensity score matching study.

The safety and efficacy of on-label use of pipeline embolization devices (PEDs) are well established; however, there is much controversy over their off-label use. This study aimed to investigate the safety and efficacy of the off-label use of PEDs for treating intracranial aneurysms. This single-center study retrospectively included patients with digital subtraction angiography, computed tomographic angiography, or magnetic resonance angiography confirmed intracranial aneurysms treated with PEDs who were admitted to our institution between 1 January 2018 and 1 July 2022. Patients were divided into on- and off-label groups according to the Food and Drug Administration criteria published in 2021. Propensity score matching (PSM) was used to balance disparities in baseline information between the two groups. Safety outcomes included postoperative mortality and complication rates, whereas effectiveness outcomes included aneurysm occlusion rate (O'Kelly-Marotta grading system C + D grades), retreatment rate within 12 months, and postoperative functional score [modified Rankin scale (mRS) score]. The study was approved by the Ethics Committee of Scientific Research and Clinical Trial of the First Affiliated Hospital of Zhengzhou University (Ethics number: KY 2018-098-02). All patients provided informed consent. A total of 242 patients with 261 aneurysms (160 on-label and 101 off-label aneurysms) were included in this study. PSM yielded 81 pairs of patients matched for baseline information. Postoperative hemorrhagic, ischemic, and procedure-related complication rates did not reach statistical significance. In addition, no statistically significant differences in the aneurysm occlusion rate, retreatment rate within 12 months, postoperative functional score (mRS score), or mRS score deterioration rate were observed between the two groups. A higher incidence of in-stent stenosis was observed in the off-label (4.9% vs. 21%, p = 0.002) group than in the on-label group; however, all patients were asymptomatic. Compared with on-label use, off-label use of PEDs for treating intracranial aneurysms did not increase the risk of complications, and the occlusion rates were comparable. Therefore, decisions regarding clinical management should not rely solely on on- or off-label indications.

HIV. Long-acting treatment : clinical experience, limits and future perspectives

In this article, we first present the current administration criteria, the risk factors for virological failure, and our practical experience with the first long-acting injectable HIV treatment available in Switzerland (the combination of cabotegravir/rilpivirine). We then discuss the theoretical and practical potential, as illustrated by an innovative study in San Francisco, provided by administering long-acting treatment outside the current criteria. This approach could notably offer antiretroviral treatment to particularly vulnerable populations for whom oral antiretroviral therapy is sometimes challenging. Finally, we touch upon the future drug prospects of long-acting treatments under study for HIV.

Dynamics of Virological and Clinical Response Parameters of Bulevirtide Treatment for Hepatitis D: Real-World Data

Background and aimsThe entry inhibitor bulevirtide represents the first specific treatment for Hepatitis-D-virus (HDV)-infected patients. In clinical trials, around 80% of patients achieve normalization of alanine aminotransferase (ALT) with about 60% virological response after one year, but little is known about the dynamics of responses and clinical predictors of treatment outcomes. We report our single-center data from 15 patients and describe response dynamics, clinical outcomes and predictive factors for treatment response. MethodsRetrospective data from 15 patients have been analyzed at our department who started treatment with bulevirtide between 10/2020 and 08/2022. According to our standard procedures laboratory parameters were controlled monthly; transient elastography was performed every three months, treatment duration was twelve months. ResultsTreatment response rates after one year of treatment were similar to published data from clinical trials. ALT normalization usually occurs between month 2-6 of treatment, followed by a virological response after ≥ 6 months. Patients with more severe hepatitis at treatment start were less likely to respond in the first year of treatment. Loss of HDV-RNA was observed for one third of patients after ≥1 year of treatment. Low body-mass-index and high Alpha-fetoprotein at baseline were possible predictors of a delayed treatment response. ConclusionBulevirtide is a safe treatment option for HDV, leading to a fast hepatological response. Of note, decrease of transaminases precedes virological response. Patients with high viral load and ALT levels respond slower, but non-responders (as classified by Food and Drug administration criteria) still show reduction of viremia. Longer observation periods are required to determine the optimal duration of bulevirtide monotherapy.

In the eye of beholder? The notions of quality in the humanities

Abstract In this article we attempt to reconstruct the tacit and implicit notions of quality in the humanities. This reconstruction is based on a series of semi-structured qualitative interviews with 33 humanities scholars. Applying Max Weber’s theory of authority, we argue the quality notions have two different sources—external and internal. External sources correspond to the Weber’s types of authority: traditional authorities (academic tradition, professors, PhD advisors), rational-legal authorities (research administrators, policy makers) and charismatic authorities (‘the great minds’, ‘the founding fathers’ in a given academic field). Internal sources providing the quality notion do not fit into Weberian classification. These sources are based on the personal experience of a humanities researcher’s evaluation practices, which cannot be reduced to either type of authority above. Combining the interview data and Max Weber’s theory of authority, we try to demonstrate the existence of four different and sometimes incompatible notions of quality in the humanities: administrative; individual; semi-administrative, semi-individual; moderate individual. These notions are interpreted as ideal types, which serve as a regulative ideas rather than objective representations of research evaluation reality. The manuscript is important to Research Evaluation for the following reasons: first, it reconstructs the different types of notions of quality, which are crucial in better understanding peer review and other qualitative research evaluation practices; second, it provides better understanding of individual evaluator’s premises; third, it provides opportunity to have a glimpse beyond dominant administrative quality notions and criteria as usually the perspectives of the humanities researchers are neglected.

Study of Pharmacokinetics for Ivermectin B1a from Beagle Dogs.

Ivermectin has been widely used for antiparasitic drug, and has recently shown a broad-spectrum antiviral activity, including anti-Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, the pharmacokinetic property of ivermectin has not been fully investigated yet. During the plasma preparation, ~32-46% of ivermectin was found in the precipitation. An Liquid Chromatograph-Mass Spectrometer (LC-MS/MS) method for ivermectin in the whole blood samples from beagle dogs was developed and validated. The specificity, accuracy, precision (intra-day and inter-day), matrix effect, recovery and stability of analyte reported here are satisfied with the criteria of Food and Drug Administration (FDA)-Bioanalysis guideline. The oral administrations pharmacokinetics of ivermectin in beagle dogs under fasting and after high-fat meal were studied, and the following parameters were obtained: fasting Cmax, 104 ± 35μg·L-1; area under the concentration-time curve (AUC0-∞), 2,555 ± 941h·μg·L-1; and high-fat meal Cmax, 147 ± 35μg·L-1; AUC0-∞, 4,198 ± 1,279h·μg·L-1. When the P-gp inhibitor curcumin was also coadministrated orally, Cmax and AUC0-∞ were found to be 177 ± 57 and 4,213 ± 948h·μg·L-1, respectively. With the comparison to fasting treatment, coadministration of P-gp inhibitor curcumin resulted in increase of the exposure of ivermectin by 1.6-fold, while the exposure after the high-fat diet versus fasting was increased approximately in 1.4-fold, indicating that alternative absorption might play an important role for increasing the exposure of ivermectin for future clinic applications.

Safety and immunogenicity of locally produced trivalent inactivated influenza vaccine (Tri Fluvac) in healthy Thai adults aged 18–64 years in Nakhon Phanom: A Phase III double blinded, three-arm, randomized, controlled trial

BackgroundDomestic influenza vaccine production facilitates a sustainable supply for mitigating seasonal influenza and improves national health security by providing infrastructure and experience for pandemic vaccine production, if needed. MethodsA Phase III, double blind, randomized controlled trial was conducted from Sep 2019-Oct 2020 in healthy adults 18–64 years in Nakhon Phanom, Thailand. Randomization (3:3:1) compared study vaccine (Tri Fluvac), saline placebo, and an active comparator (licensed vaccine). Primary outcomes were superior efficacy compared to placebo based on RT-PCR-confirmed influenza virus infection within 12 months and non-inferiority compared to active comparator based on immunogenicity (HAI assay) at 28 days. Safety was also assessed. ResultsThe trial enrolled 4,284 participants (Tri Fluvac = 1,836; placebo = 1,836; active comparator = 612). There were 29 RT-PCR positive influenza infections (10 Tri Fluvac, 5.5/1,000 PY; 19 placebo, 10.4/1,000PY; 0 comparator) for an absolute protective efficacy of 46.4 (95 % CI = −22.0–76.5) compared with placebo, but the power was 43.7 %. Seroconversion difference rates between Tri Fluvac and comparator at Day 28 were 1.74 (95 % CI: −2.77, 6.25), 2.22 (−2.40, 6.84), and −0.57 (−5.41, 4.27) for A(H1N1), A(H3N2), and B strains, respectively. Adverse and severe adverse events occurred in 175 (9.5 %) Tri Fluvac, 177 (10.8 %) placebo, and 66 (10.8 %) comparator arms (p-value = 0.437, Tri Fluvac vs. comparator) ConclusionsTri Fluvac was well tolerated, and immunogenicity was non-inferior to the active comparator, meeting U.S. Food and Drug Administration (FDA) criteria for adult vaccine licensure. Few acute respiratory infections were reported during intense COVID-19 pandemic restrictions, resulting in insufficient power to evaluate clinical efficacy.

EPID-31. BRAIN TUMORS IN UNITED STATES MILITARY VETERANS

Abstract Veterans account for ~7% of the adult United States population, with half seeking care through the Veterans Health Administration (VHA). A comprehensive analysis of incidence and survival for brain tumors in the Veteran population has been lacking. Veteran data was obtained from VHA Medical Centers that diagnose and treat cancer via the VHA Corporate Data Warehouse. Brain tumor statistics on the overall US population were generated from the Central Brain Tumor Registry of the United States data. Cases were defined as individuals (≥18 years) with a primary brain tumor, diagnosed between 2004-2018, and identified using administrative criteria based on International Classification of Diseases for Oncology, Third Edition (ICD-O-3) topography and morphology codes. Annual age-adjusted incidence rates (AAIR) and 95% confidence intervals were estimated per 100,000 population. Kaplan-Meier survival curves were generated to evaluate overall survival outcomes among Veterans. The Veteran population was primarily white (78%), male (93%), and between 60-64 years old (18%). Individuals with a primary brain tumor in the general US population were mainly female (59%) and between 18-49 years old (28%). The overall AAIR of primary brain tumors from 2004-2018 within the VA cancer registry was 11.6. Non-malignant tumors were more common than malignant tumors (AAIR:7.19 vs 4.42). The most diagnosed tumors in Veterans were non-malignant pituitary tumors (AAIR:2.96), non-malignant meningioma (AAIR:2.62), and glioblastoma (AAIR:1.96). In general, in the Veteran population, survival outcomes became worse with age and were lowest among individuals diagnosed with glioblastoma. Differences between the Veteran and US population can be broadly attributed to the differences in the demographic composition of these groups. Prior to this study, there have been no reports on national level incidence rates and survival outcomes for Veterans. Statistics like these provide vital information that drive efforts to understand disease burden and improve outcomes for individuals with primary brain tumors.

Identification of the Establishment of the Regional Public Service Agency (BLUD) of Pasar Besar Ngawi in Ngawi District, Ngawi Regency

Improving services to merchants in traditional markets is one solution where competition and the number of modern stores are growing. The application of BLUD in traditional market management is a creation in overcoming competition. With the BLUD system, it will make the relevant regional apparatus work unit (SKPD) more flexible in managing the market, both traders and the budget generated from the merchant levy for market progress. Representative data is needed to determine the feasibility of establishing the Ngawi Large Market Market BLUD in Ngawi District, Ngawi Regency. The purpose of this study is the identification of the fulfillment of substantive, technical and administrative requirements in the establishment of BLUD in Pasar Besar Ngawi in Ngawi District, Ngawi Regency. This type of research is descriptive research using a quantitative approach. Data collection was carried out using multiple sources of evidence, namely questionnaires, interviews, documentation and direct observation. Data analysis techniques use quantitative descriptives with substantive, technical, and administrative criteria. The results of the study found that the Ngawi Large Market in Ngawi District, Ngawi Regency has not met the two criteria of substantive requirements, has met the criteria of technical requirements, and has not met the eight criteria of administrative requirements.

Abstract 161: Repeated administration of thrombolytic therapy in the setting of stuttering lacunar infarct

Introduction Tissue plasminogen activator (tPA) is the standard of care for the treatment of acute ischemic stroke with symptom onset within 4.5 hours. One exclusion criterion for tPA administration is stroke within 3 months due to the presumed increased risk of hemorrhage. While the rate of early recurrent stroke (ERS) within 3 months is as high as 14.5‐18.3%, the safety and effectiveness of repeated tPA administration remain unclear. An increasing number of studies pose a challenge to this recommendation. One study identified 19 patients who received tPA for ERS and found no symptomatic intracranial hemorrhage. Fifteen other studies with a cohort of 57 patients (including one patient receiving repeated tPA within 90 minutes) reached the same conclusion that repeated tPA is safe in ERS. We present a patient with stuttering motor weakness who received intravenous (IV) tPA twice, 3 days apart with discharged modified Rankin scale (mRS) of 3. Methods The patient was identified in routine clinical practice. Results Our patient is a 61‐year‐old right‐handed Caucasian woman with a medical history of untreated hypertension presented with sudden onset of left arm and leg weakness. IV tPA was given at the local emergency department (ED) and she was then transferred to our comprehensive stroke center. Upon arrival, her National Institutes of Health Stroke Scale (NIHSS) was 0. Her symptoms were completely resolved. Computed tomography (CT) head was unremarkable and CT angiography (CTA) did not show significant stenosis or occlusion. Magnetic resonance imaging (MRI) of the brain was negative for an acute infarct. She was diagnosed with a transient ischemic attack and was discharged home with aspirin and a high‐intensity statin for secondary stroke prevention. She presented to the ED the next day with identical left‐sided weakness again. Her NIHSS was 5 this time and IV tPA was given again. MRI showed an acute infarct in the right posterior limb of the internal capsule. Transthoracic echo did not reveal an intracardiac shunting or thrombus. The stroke mechanism was small vessel disease, and anti‐hypertensive medications were added to the treatment. She was discharged to an acute rehabilitation center with an mRS of 3 and her 90‐day mRS was 1 on follow up. Conclusion Management of ERS is a challenging issue in stroke care. Our case adds value to the current limited literature demonstrating the safety and effectiveness of repeated tPA in ERS, especially in patients with MR negative stuttering lacunar infarct and subsequent improvement following tPA. Further research with larger registries is needed to identify appropriate selection criteria for repeated tPA use in this patient population.

Do Local Socio-Economic Structures Determine the Spatial Distribution of Human Capital? Analysis of Connections for Rural Areas in Poland

The article has an empirical nature. The subject of detailed analysis is the variations in spatial distribution of human capital in rural areas of Poland and the analysis of the correlation of this phenomenon with local structures of the socio-economic development process. The diagnosis and assessment of variations in the spatial distribution of human capital were performed based on an author’s indicator—a synthetic measure of human capital level (HCI—human capital index). The characterisation of local socio-economic structures was based on the typology of rural areas according to Rural Development Monitoring (RDM 2014 and 2023). The study was conducted for rural areas in Poland defined by the Main Statistical Office based on the administrative criteria of rural and rural-urban municipalities. A total of 2172 municipalities were covered by the study. The data analysis was conducted spatially at the NUTS 5 level and comparatively at the NUTS 2 level for the years 2013–2018. The assumption was verified that the processes of human capital concentration in rural areas in Poland are related to local socio-economic structures of development processes, and the local structure factor that influences the existing differences is the degree of use of agricultural functions. The results of statistical tests positively verify this relationship as statistically significant. Moreover, the article provides strong arguments for shaping regional and rural policy and its implementation. The assumption about the need to change the approach to the study of rural space was positively verified; it is suggested to move away from analyses conducted at the level of the NUTS 2 region to the level of the NUTS 5 municipality. Research on rural areas makes sense only from a local perspective; it allows for a more accurate illustration of the specificity of local communities, revealing their development potentials and barriers, and, as a result, more effective programming of instruments supporting local development, dedicating specific support programs individually for each municipality, while the regional approach presents the state of differences too generally and may often lead to incorrect interpretation. In the empirical part of the article, taxonomic methods of hierarchy (patternless) and classification of multi-featured objects were used. As a result, each object (municipality) was assigned a synthetic measure—the relative human capital level index (HCI). Based on the HCI index, an ex-post hierarchical classification of municipalities was carried out. The main sources of data (diagnostic variables) for the construction of the HCI index were the Local Data Bank of the Central Statistical Office (BDL GUS), the national census of NSP 2011, the Ministry of Finance, the Ministry of Family and Social Policy, and District Examination Boards. The source of data on local socio-economic structures expressed based on the typology of rural areas according to the Rural Development Monitoring (RDM) methodology was the European Fund for the Development of Polish Villages (EFRWP).

Sulfamethoxazole-trimethoprim for pneumocystis pneumonia prophylaxis, causes of discontinuation and thrombocytopenia observed during administration: A single-center retrospective study

IntroductionThe development of pneumocystis pneumonia (PCP) has recently become a growing concern; thus, its prevention has become increasingly important. Sulfamethoxazole-trimethoprim (ST) is a cost-effective first-line and prophylactic treatment for PCP. However, ST administration criteria for PCP prophylaxis remain unclear and are often discontinued because of adverse events (AEs). In this study, we aimed to investigate the causes of ST discontinuation and the associated AEs using objective data. MethodsWe retrospectively analyzed the data of 162 patients admitted to Kansai Medical University Hospital between January 2018 and December 2020, who received ST for PCP prophylaxis. We compared clinical characteristics, laboratory data, and incidence of AEs between ST non-discontinuation and ST discontinuation groups. Additionally, we divided the patients into non-developing and developing thrombocytopenia (≥ Grade 1) groups based on the investigation results. ResultsNo patients developed PCP while receiving ST. The most common causes of ST discontinuation were thrombocytopenia (37%), liver dysfunction (20%), and rash (18%). Multivariate analysis revealed thrombocytopenia (≥ Grade 1) as a factor significantly associated with ST discontinuation. Furthermore, we identified three factors correlated with thrombocytopenia (≥ Grade 1): age ≥50 years, lymphocyte count <1000/μL, and platelet count <180,000/μL. ConclusionsPatients with the aforementioned factors are at higher risk of developing thrombocytopenia (≥ Grade 1) during ST administration for PCP prophylaxis. Therefore, platelet count monitoring is essential to enhance safety and efficacy of ST treatment. Nonetheless, further research is warranted to explore additional implications and interventions.

Leber's Hereditary Optic Neuropathy (LHON): Clinical Experience and Outcomes after Long-Term Idebenone Treatment.

Leber's hereditary optic neuropathy (LHON) is a rare disease. Large studies are difficult to conduct; therefore, case reports provide valuable data. Since 2015, patients have been treated with Idebenone. The aim of this paper is to share our experience with diagnosing and managing patients in different stages of LHON. We designed a case series study, including four patients undergoing genetic testing and ophthalmologic examination. Criteria for Idebenone administration and follow-up were presented. All patients had mutation 11778G>A in MT-ND4. The first patient, an 82-year-old man, with long history of vision loss, had no indication for Idebenone. Two additional cases emerged within the same family: a 40-year-old brother and a 31-year-old sister. Both received Idebenone, with good outcomes only for the female. After a one-year regimen, they were lost to follow-up. The fourth patient, a 46-year-old man, was diagnosed in the subacute stage. Idebenone administration was deferred, allowing progression of visual field defects. After 17 months of treatment, visual improvement appeared. The treatment was continued for 36 months, with short interruptions, resulting in good outcomes. Our study demonstrated positive results with long-term Idebenone use. Contrary to medical literature, our female patient had a favorable evolution, despite the delayed diagnosis.

Developing an extended producer responsibility system for solid waste management in Jordan using multi-criteria decision-making approach.

To move from a traditional end of pipe approach into a more sustainable solid waste management system, the Jordanian Government has recently passed a set of new regulations The National Solid Waste Management Strategy has put a road map to encourage circular economy practices. One of the considered policy instruments is the adoption of the extended producer responsibility (EPR). The current study aimed to adopt a multi-criteria decision-making method to select the most convenient EPR structure within the Jordanian context. The study used analytical hierarchy process (AHP) and fuzzy AHP (FAHP) techniques to select the suitable type of producer responsibility organization (PRO) structure. A four-level hierarchy model was constructed with 4 criteria, 10 sub-criteria and 3 PRO alternatives. The analysis revealed that the legal and administrative criteria is the most important one (0.47) followed by environmental criteria (0.22), whereas the least important ones were socio-economic (0.17) and technical criteria (0.13). The most preferable PRO alternative was found to be PRO with profit. There were slight differences between all weight values under AHP and FAHP. Despite the availability of several laws, there is a need to develop the legal and administrative framework to enable the adoption of EPR in Jordan. Research should be the first step in the process of EPR system design. None of the previous studies conducted used the AHP and FAHP in assessing and selecting the EPR systems.

Severe Asthma and Biological Therapies: Now and the Future.

Recognition of phenotypic variability in pediatric asthma allows for a more personalized therapeutic approach. Knowledge of the underlying pathophysiological and molecular mechanisms (endotypes) of corresponding biomarkers and new treatments enables this strategy to progress. Biologic therapies for children with severe asthma are becoming more relevant in this sense. The T2 phenotype is the most prevalent in childhood and adolescence, and non-T2 phenotypes are usually rare. This document aims to review the mechanism of action, efficacy, and potential predictive and monitoring biomarkers of biological drugs, focusing on the pediatric population. The drugs currently available are omalizumab, mepolizumab, benralizumab, dupilumab, and 1ezepelumab, with some differences in administrative approval prescription criteria between the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Previously, we described the characteristics of severe asthma in children and its diagnostic and therapeutic management.

Bioanalytical method validation and application to a phase 1, double-blind, randomized pharmacokinetic trial of a standardized Centella asiatica (L.) Urban water extract product in healthy older adults.

Introduction: Centella asiatica is an herbaceous plant reputed in Eastern medicine to improve memory. Preclinical studies have shown that C. asiatica aqueous extract (CAW) improves neuronal health, reduces oxidative stress, and positively impacts learning and cognition. This study aimed to develop and validate bioanalytical methods for detecting known bioactive compounds from C. asiatica in human biological matrices and apply them to a human pharmacokinetic trial in healthy older adults. Methods: High performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) was used for detecting triterpenes and caffeoylquinic acids from C. asiatica, or their metabolites, in human plasma and urine. Validation parameters including linearity, precision, accuracy, recovery and thermal stability were evaluated. The method was applied to a Phase I, randomized, double-blind, crossover trial of two doses (2 or 4g) of a standardized C. asiatica water extract product (CAP) in eight healthy older adults. Pharmacokinetic parameters were measured over a 12-h post administration period and acute safety was assessed. Results: The method satisfied US Food & Drug Administration criteria for linearity and recovery of the analytes of interest in human plasma and urine. The method also satisfied criteria for precision and accuracy at medium and high concentrations. Single administration of 2 and 4g of CAP was well tolerated and safe in healthy older adults. The parent triterpene glycosides, asiaticoside and madecassoside, were not detected in plasma and in minimal amounts in urinary excretion analyses, while the aglycones, asiatic acid and madecassic acid, showed readily detectable pharmacokinetic profiles. Similarly, the di-caffeoylquinic acids and mono-caffeoylquinic acids were detected in low quantities, while their putative metabolites showed readily detectable pharmacokinetic profiles and urinary excretion. Discussion: This method was able to identify and calculate the concentration of triterpenes and caffeoylquinic acids from C. asiatica, or their metabolites, in human plasma and urine. The oral absorption of these key compounds from CAP, and its acute safety in healthy older adults, support the use of this C. asiatica product in future clinical trials.

Systematic Review of Decision-Making Tools, Alternatives and Criteria in Urban Solid Waste Management

This scientific article provides a comprehensive review of the main tools and criteria employed in Municipal Solid Waste Management (MSWM) for achieving sustainable waste management. The objective of this study was to evaluate the most effective technology or combination of technologies for treating urban solid waste, along with the most used methodology for selecting such technologies. To achieve this, we conducted a systematic review of the literature, carefully selected relevant articles, and compiled data from various criteria studied to facilitate a comprehensive discussion and evaluation of the findings. The article evaluates the main tools and their combinations used in aiding decision-making in MSWM, in accordance with the objectives of the decision. The benefits of integrated waste management are highlighted, along with the challenges associated with its implementation. These challenges are inherent in each situation and must be evaluated individually, based on their characteristics. Optimizing sustainability criteria in MSWM can be achieved by searching for a technology implementation sequence. The article also synthesizes the frequency of each MSWM technology, such as landfill, incineration, anaerobic digestion, composting, gasification, pyrolysis, and recycling, being selected in decision-making in the literature. Furthermore, an analysis of the environmental, economic, social, technical, political, and administrative criteria and their sub-criteria in MSWM is carried out. It has been observed that Analytic Hierarchy Process and Life Cycle Assessment are the primary tools involved in multicriteria decision-making for Municipal Solid Waste Management (MSWM). Moreover, these tools demonstrate ease of integration with other methods, showcasing their flexibility and comprehensiveness. While the combination of MSWM technologies is a common goal in the studies examined, integrating a larger number of technologies poses challenges. Finally, the most frequently studied criteria in MSWM, in descending order of frequency, are environmental, economic, social, technical, and political/legislative/administrative aspects. Therefore, it is crucial to explore the less frequently studied criteria to overcome barriers and establish a more sustainable management approach for urban solid waste. In conclusion, the article suggests future work, including the development of a model that assists in the technology implementation sequence and assessing the feasibility of integrating the largest number of MSWM technologies. Although gaps exist in the literature on MSW issues and potential solutions, this review provides valuable information for decision-makers in MSW planning and in the search for scenarios that demonstrate superior performance.

Effects of climate variability on respiratory diseases in the Western Region of Bahia, Brazil

ObjectivesThis study aimed to analyse hospitalisations for respiratory diseases in the Western Region of Bahia, Northeast Brazil, from 2010 to 2019, and to explore possible correlations with meteorological data. Study designThis descriptive, epidemiological, ecological study analysed data from 37 municipalities in the Western Bahia health macro-region, defined according to geographical, administrative, demographic, epidemiological, social and cultural criteria, and accounting for availability of health resources. MethodsHospitalisation data for respiratory diseases, including total admissions and disease frequency, mean and prevalence, were obtained from DATASUS (Ministry of Health). The data were evaluated by sex, age group and city. Statistical tests, such as the Chi-squared test and analysis of variance, were used for data analysis. Meteorological data were compared using the t-test and Mann–Whitney test. Correlations between health indicators and weather data were assessed using the Pearson and Spearman correlation coefficients. ResultsOver the investigated period, there were 536,195 hospitalisation records in the region, with respiratory diseases accounting for 17.1% of admissions. Notably, 40% of respiratory hospitalisations were among children aged 0–9 years. The most prevalent respiratory conditions were pneumonia and asthma, which together constituted 73% of all respiratory hospitalisations. A significant negative correlation was observed between respiratory diseases and rainfall (r = −0.70, P = 0.011). ConclusionsPneumonia and asthma remain important causes of hospitalisation among children in the Western Bahia Region. The study findings suggest that respiratory diseases are influenced by rainfall, possibly due to increased atmospheric pollutants during time of low rainfall. These findings emphasise the importance of environmental factors in the development and exacerbation of respiratory diseases.

Are we providing complete drug information to its users? Status of information adequacy of package insert in India.

Package inserts (PIs) serve detailed information on drug products to the users and primary care physicians, so information should be accurate, reliable, and as per the regulatory guidelines. The study aims to analyze the information adequacy of the PIs available in the Indian market as per Drug and Cosmetic Rule 1945 and US Food and Drug Administration criteria. A cross-sectional study was conducted on PIs collected from accessible pharmacy stores. Information provided was recorded as per criteria, and total information adequacy score (IAS) and information deficiency (IDS) score were calculated. The association of factors like single-drug/FDCs, a company of origin Indian/multinational, and route of administration (ROA) with IDS was statistically analyzed. Of 120 PIs, 60%, 86.66%, and 73% were single-drug, prescription-drug, and drugs by Indian manufacturers, respectively. Most PIs provided generic names, ROA, and indications for use. 85%, 12%, 29.16%, and 3.33% provided information on PIs on the ability to drive, drug-food interactions, drug-drug interactions, and addiction potential, respectively. Lacking area was information on use in pediatrics-geriatrics (30%), excipients (28.3%), preclinical (15.83%), post-surveillance data (18.33%), and approval date (2.5%). There was a statistically significant difference between pharmaceutical score (3.22 vs 4.12), therapeutic score (11.5 vs 13.18), and total IAS (14.78 ± 3.39 vs 17.31 ± 2.33) of Indian and multinational companies. IDS was statistically significantly different in both pharmaceutical and therapeutic categories for single-drug vs FDCs (P = 0.00001), OTC vs prescription drugs (P < 0.05), and Indian vs multinational companies' PIs (P = 0.00001). Numerous facets of information are lacking in PIs, and they do not impart whole information, especially of Indian origin, as per objective IDS.

Assessment of Compliance Indicators for Examination Requests at University Hospital Center of Kati

Introduction: The request for a radiological examination is a prescription sent to a radiologist by a doctor or another health professional with the required skills. The aim of our work was to analyze the compliance of examination requests in the medical imaging department of CHU-Kati. Methodology: This was a prospective and cross-sectional study of medical imaging examination requests in the Medical Imaging Department of Kati University Hospital over a period of one month from December 5, 2015 to January 5, 2016. The parameters studied were on the compliance criteria which are eight (8) in number, five of which are administrative (date of the request, requesting department, patient's surname and first name, patient's age, applicant's identification) and three (3) clinical (anatomical region, reason for the examination and purpose of the examination). Results: At the end of our study, we identified 300 imaging examination requests distributed as follows: standard radiography was 66% followed by ultrasound 19.69%, scanner 12% and radiography examinations with contrast product 2.33%. The largest number of bulletins belonged to the C.H.U of Kati with 53% followed by the military infirmary, 31.43% and other 15.57% of cases (Other means the other structures (C.H.U-Gabriel TOURE, C.H.U-Point G, clinics and medical practices)). The least noted administrative criterion was the patient's age with 25.33% of cases. The anatomical region requested on the reports was present in 100% of the cases, the reason for the examination represented 75.57% of the cases and only on 7.33% of the requests for examination existed the purpose of the examination. The information found on the requests was illegible in 3.33% of the cases and the profession of the patients was noted in 98.33% of the cases. The presence of all the administrative criteria of the requests for examination was nil Compared to the relationship between the qualification and the other criteria of conformity: The address ..

Nitrate Reductase Assay for Rapid Determination of Methicillin-Resistant Staphylococcus aureus Clinical Isolates.

To evaluate the performance of nitrate reductase assay (NRA), a rapid, colorimetric method for the determination of methicillin resistance in Staphylococcus aureus isolates obtained from the culture collection of the Akdeniz University Hospital Central Laboratory, Antalya, Türkiye. Identification for all 290 S aureus isolates at the species level was performed via matrix-assisted laser desorption/ionization-time of flight. Isolates were tested with NRA for methicillin resistance. The cefoxitin broth microdilution (BMD) method recommended by the Clinical and Laboratory Standards Institute was used as the reference method in the study. S aureus ATCC 29213 and S aureus ATCC 43300 strains were used for quality control. According to Food and Drug Administration criteria, the category agreement between NRA and BMD was found to be 100%. The essential agreement between both methods was determined to be 96.20%. There is no minor, major, or extremely major discrepancy between both methods. The results show that NRA is a rapid, practical, and reliable colorimetric method for detecting MRSA.