Clinical Hospital Research Articles

Nurse-led framework to improve the safety and quality of residential aged care (HIRAID® Aged Care): protocol for a stepped-wedge cluster randomised controlled trial

BackgroundThe health issues experienced by older people can often be severe and complex, and an increasing number are using residential aged care services to meet their care needs. High-quality nursing care is fundamental to the health and safety of aged care residents and is contingent on nurses’ accurate assessment, informed decision-making, and delivery of timely interventions. However, the role of the aged care nurse is often challenging, impeded by factors such as understaffing, high workloads, and a lack of access to clinical infrastructure and resources. When these challenges mount, residents are put at greater risk of adverse outcomes, such as avoidable clinical deterioration and hospital transfers. This study describes the adaptation and implementation of the emergency nursing framework, HIRAID® (History including Infection risk, Red Flags, Assessment, Interventions, Diagnostics, reassessment, communication and plan)—a tool to assist nurses’ assessment, decision-making and care in residential aged care.MethodsThe HIRAID® framework will be adapted for residential aged care using a real-time Delphi and panel of aged care and nursing experts. The co-designed HIRAID® Aged Care framework will be trialled in 23 residential aged care homes in Sydney, Australia, in a modified stepped-wedge cluster randomised controlled trial design. All homes will be randomised into one of four clusters. Outcomes of interest include the rate of clinical deterioration events resulting from nurses’ actions, the rate of hospital transfers determined to be inappropriate, performance against the national mandatory aged care quality indicators, resident satisfaction with care, nurse and medical staff satisfaction with communication, and the quality of nursing documentation. These outcomes will be evaluated using a combination of qualitative and quantitative analysis of routinely collected resident data, expert assessments of facility documentation events against validated criteria, and pre- and post-intervention surveys of residents, family carers, nurses, and medical staff.DiscussionThis protocol describes a pragmatic trial that aims to translate an evidence-based framework from the emergency care context into residential aged care. The adapted HIRAID® Aged Care framework will be the first of its kind to standardise and guide holistic nursing assessment, decision-making, and documentation in residential aged care in Australia.Ethics and disseminationThis research has been approved by the Western Sydney Local Health District Human Research Ethics Committee: 2023/ETH00523. A waiver of consent has been approved to access resident health data and nursing documentation at each participating site.Trial registrationAustralian and New Zealand Clinical Trial Registry, ACTRN12623000481673. Registered 12 May 2023.Protocol versionVersion 1.0 6 February 2024.

Glucosuria as a major mechanism-associated effect of sodium-glucose cotransporter 2 inhibitors: Is there cause for concern?

Introduction. One of the main mechanisms of action of SGLT2 inhibitors is an increase in renal excretion of glucose and sodium, development of glucosuria against the background of decreased levels of daily glycemia. The frequency of glucosuria development in patients without DM/prediabetes, receiving SGLT2 inhibitors for the treatment of CHD or CKD, as a consequence of the mechanism of action of SGLT2 inhibitors inhibitors is poorly studied and seems to be very interesting.Aim. To evaluate in real clinical practice the frequency of the development and severity of glucosuria in patients with CHF treated with inhibitors of SGLT2 inhibitors both on the background of concomitant DM2 and without type 2 DM.Materials and methods. Within the framework of a one-stage, prospective, observational study we evaluated the frequency of development and severity of glucosuria in patients with CHF, receiving SGLT2 inhibitors inhibitors, who were in the cardiology department of V.P. Demikhov State Clinical Hospital of Moscow. A total of 230 patients were included in the analysis.Results. The mean age of the patients was 74 [66; 83] years. Median LVEF was 36 [29; 44] %, NTproBNP 1019 [423; 2355] pg/ml. Heart failure with reduced ejection fraction (HFrEF) was recorded in 64.81% of patients, 17.13% had HF with mildly reduced ejection fraction and 18.06% had a СHF preserved ejection fraction. DM2 was present in 38.7 percent of patients with СHF. Among patients with CHF, the ‘glucosuria phenomenon’ due to the administration of SGLT2 inhibitors was observed in 31.16% of those without DM2, and in 52.27% of СHF patients with concomitant DM2.Conclusion. In patients with CHF receiving SGLT2 inhibitors therapy, the ‘glucosuria phenomenon’ developed in one in three patients without overt carbohydrate metabolism abnormalities and one in two with DM2. The findings suggest that the glucosuria effect of SGLT2 inhibitors is not a required event even in patients with DM2, which may influence the incidence of adverse events in general clinical practice. And the cardioprotective benefits of SGLT2 inhibitors may be due to other mechanisms unrelated to glucose excretion, which, according to recent studies, is considered a surrogate predictor of favorable prognosis concerning CHF and renal outcomes. Nevertheless, additional clinical and experimental studies are required to determine the cardioprotective mechanisms of SGLT2 inhibitors and the predictive value of drug-induced glucosuria.

Experience with antiviral therapy in patients with chronic hepatitis C and metabolic syndrome

Relevance. This article presents the results of clinical studies on the use of antiviral drugs for treating chronic hepatitis C (CHC) and metabolic syndrome (MS).Objective. Analysis of the effectiveness of CHC therapy and its impact on the components of MS.Materials and methods. The study was conducted at the Yaroslavl Regional Infectious Diseases Clinical Hospital between 2015 and 2023. All patients were prescribed a standard set of clinical, laboratory, and instrumental examinations upon admission to the hospital (general and biochemical blood tests, blood tests for HCV genotype and viral load, ultrasound of the abdominal organs). Treatment was performed using different antiviral regimens.Results. Among the regimens used, only interferon-containing regimens resulted in changes in the components of metabolic syndrome. A significant decrease in abdominal obesity and triglyceride levels was observed (p< 0.05) The changes mainly affected patients with genotypes 2 and 3, which confirms the "viral" genesis of the development of these components of MS.

Association of long-term exposure to ozone with cardiovascular mortality and its metabolic mediators: evidence from a nationwide, population-based, prospective cohort study

Previous studies about chronic effects of ozone (O3) on cardiovascular mortality are scarce and inconclusive. We aimed to investigate the association between cardiovascular mortality and a broad range of long-term O3 exposure levels. This analysis included 3,206,871 participants aged 35-75 years enrolled in the ChinaHEART study. Participants were recruited from the 31 provinces of the Chinese mainland between January 2015 and December 2020. The five-year average O3 concentrations before baseline visits were calculated to represent long-term exposure. Over a median follow-up period of 4.7 (interquartile range: 3.7-6.2) years, 35,553 (1.1%) participants died from cardiovascular diseases (CVD). Following multivariable adjustment, nonlinear relationships were identified between O3 concentrations and CVD and ischemic heart disease (IHD) mortality, with inflection points at 85.44 and 88.15μg/m3, respectively. Above these points, a 10.0μg/m3 increase in the O3 level was associated with a 13.9% (hazard ratio [HR]: 1.139, 95% confidence interval [CI]: 1.096-1.184) and 25.0% (HR: 1.250, 95% CI: 1.151-1.357) greater risk of CVD and IHD mortality, respectively. Conversely, O3 exposure exhibited a linear relationship with ischemic stroke mortality. Moreover, the metabolic factors explained more than half of the association between O3 exposure and CVD mortality. Substantial influences of long-term O3 exposure on CVD mortality were identified, with notable mediation proportions attributed to metabolic factors. These findings could facilitate the air quality standard revisions and risk reduction strategy making in the future. This study was supported by the CAMS Innovation Fund for Medical Science (2021-1-I2M-011), the CAMS Innovation Fund for Medical Science (CIFMS, 2022-I2M-C&T-A-010), the National High Level Hospital Clinical Research Funding (2022-GSP-GG-4), the Ministry of Finance of China and National Health Commission of China, the 111 Project from the Ministry of Education of China (B16005).

Global burden of dementia in younger people: an analysis of data from the 2021 Global Burden of Disease Study

Dementia among younger people is rapidly emerging as a global health concern; however, comprehensive research on its shifting burden trends remains insufficient. Data on the prevalence, incidence, mortality, and disability-adjusted life years (DALYs) associated with dementia occurring in individuals <70 years were extracted from the Global Burden of Diseases, Injuries, and Risk Factors Study 2021. Average annual percentage changes (AAPCs) were calculated to assess trends in age-specific rates (ASRs), including age-specific prevalence rates (ASPRs), age-specific incidence rates (ASIRs), age-specific mortality rates (ASMRs), and age-specific DALY rates (ASDRs) while young-onset dementia (YOD) burden trends were analyzed. The correlation between ASR/AAPC and the sociodemographic index (SDI) was evaluated. In 2021, the global prevalence of dementia in individuals <70 years increased by 122.33%, with a 128% increase in new cases since 1990. Concurrently, deaths and DALYs of individuals <70 years with dementia rose by 119.28% and 119.77%, respectively. The AAPCs of YOD ASRs during 1990-2021 initially increased and then decreased with increasing SDI levels, with the highest AAPCs of ASPR (2.20 [95%CI: 2.08-2.32] per 100,000), ASIR (2.25 [95%CI: 2.06-2.45] per 100,000), ASMR (2.04 [95%CI: 1.93-2.15] per 100,000), and ASDR (2.06 [95%CI: 1.99-2.13] per 100,000) observed in middle-SDI levels. Additionally, females <70 years bore a higher burden of dementia globally, and gender differences are still widening. The growth rate of YOD is accelerating, particularly in the middle to high SDI region with females bearing a disproportionately higher burden of YOD. This work was supported by grants from the National High level Hospital Clinical Research Funding, CAMS Innovation Fund for Medical Sciences, and the National Natural Science Foundation of China.

Treatment of epistaxis in Osler-Weber-Rendu disease by bevacizumab nasal spray. The EROSB study: Determining the effective dose

Treatment of nosebleeds in Osler-Weber-Rendu disease (OWRD) is a therapeutic challenge. Intranasal anti-angiogenic sprays are a promising solution, requiring scientific validation, leading us to conduct the present study. ObjectiveThe main objective was to determine the minimum effective dose of bevacizumab by intranasal spray to treat epistaxis in OWRD: i.e., the dose resulting in≥50% reduction in the number of nosebleeds at 1 month of treatment compared to the month prior to inclusion for 60% of patients. The secondary objectives were to assess treatment efficacy at 3 and 6 months and progression in the number and impact of nosebleeds, and to document pharmacokinetics. Materials and methodsThe study, named EROSB (treatment of epistaxis in patients with OWRD using a bevacizumab intranasal spray), under the French Hospitals Clinical Research Program (PHRC-I 2013), was selected by the Inter-regional Clinical Research and Innovation Group (GIRCI). It was a phase I/II prospective single-blind study based on 10 cohorts of 3 patients each, using the Continual Reassessment Method (CRM) to determine the minimum effective dose of bevacizumab. ResultsDue to difficulties in recruiting enough patients, the study was stopped after inclusion of 15 subjects. The CRM method identified 64mg as the minimum effective dose. However, this result is not interpretable due to the small number of subjects. ConclusionThe EROSB study did not succeed in identifying a minimum effective dose of bevacizumab, administered as intranasal spray that could reduce the number of nosebleeds compared to the month prior to inclusion. However, the initial results indicated almost no systemic passage of the substance.

Gut microbiome metabolites, molecular mimicry, and species-level variation drive long-term efficacy and adverse event outcomes in lung cancer survivors

The influence of the gut microbiota on long-term immune checkpoint inhibitor (ICI) efficacy and immune-related adverse events (irAEs) is poorly understood, as are the underlying mechanisms. We performed gut metagenome and metabolome sequencing of gut microbiotas from patients with lung cancer initially treated with anti-PD-1/PD-L1 therapy and explored the underlying mechanisms mediating long-term (median follow-up 1167 days) ICI responses and immune-related adverse events (irAEs). Results were validated in external, publicly-available datasets (Routy, Lee, and McCulloch cohorts). The ICI benefit group was enriched for propionate (P=0.01) and butyrate/isobutyrate (P=0.12) compared with the resistance group, which was validated in the McCulloch cohort (propionate P<0.001, butyrate/isobutyrate P=0.002). The acetyl-CoA pathway (P=0.02) in beneficial species mainly mediated butyrate production. Microbiota sequences from irAE patients aligned with antigenic epitopes found in autoimmune diseases. Microbiotas of responsive patients contained more lung cancer-related antigens (P=0.07), which was validated in the Routy cohort (P=0.02). Escherichia coli and SGB15342 of Faecalibacterium prausnitzii showed strain-level variations corresponding to clinical phenotypes. Metabolome validation reviewed more abundant acetic acid (P=0.03), propionic acid (P=0.09), and butyric acid (P=0.02) in the benefit group than the resistance group, and patients with higher acetic, propionic, and butyric acid levels had a longer progression-free survival and lower risk of tumor progression after adjusting for histopathological subtype and stage (P<0.05). Long-term ICI survivors have coevolved a compact microbial community with high butyrate production, and molecular mimicry of autoimmune and tumor antigens by microbiota contribute to outcomes. These results not only characterize the gut microbiotas of patients who benefit long term from ICIs but pave the way for "smart" fecal microbiota transplantation. Registered in the Chinese Clinical Trial Registry (ChiCTR2000032088). This work was supported by Beijing Natural Science Foundation (7232110), National High Level Hospital Clinical Research Funding (2022-PUMCH-A-072, 2023-PUMCH-C-054), CAMS Innovation Fund for Medical Sciences (CIFMS) (2022-I2M-C&T-B-010).

The factor structure of the Centre for Epidemiological Studies Depression Scale (CESD-R-20) among South African antiretroviral therapy users

Depression is a significant concern for people living with HIV and AIDS as it is associated with negative health outcomes and suboptimal adherence to antiretroviral therapy (ART). To this extent, screening for depression is essential for early detection. The CESD-R-20 is a revised four-factor questionnaire developed to assess depressive symptoms in adults. This study explored the factor structure and psychometric properties of the CESD-R-20 among 685 individuals receiving ART. Data were collected at the Infectious Diseases Clinic of a large public hospital outside Cape Town from participants who had been receiving ART for at least six months. Exploratory factor analysis (EFA) of the CESD-R-20 was performed to identify its underlying factor structure. The EFA revealed a one-factor solution termed “depressive affect,” comprising 19 items that encompassed the original factors. This finding suggests that depression is a cohesive construct rather than a collection of interconnected dimensions. The scale exhibited high internal consistency (Cronbach’s alpha = 0.95) among the sample of persons living with HIV and AIDS. Our findings indicate that the CESD-R-20 can effectively measure depressive affect as a one-factor scale in South Africans receiving ART. The scale demonstrated strong internal consistency and is suitable for screening for depressive symptoms among persons living with HIV and AIDS.

Midwifery Care Continuity of Care at Delta Mutiara Clinic and Maternity Hospital, Sidoarjo

Continuity of Care is a program to improve the provision of midwifery services continuously carried out by Midwives and as the final project for midwifery students by promoting holistic and integrated midwifery care. The aim of this study was to provide continuous midwifery care , 25 year old, Mrs. A at the Delta Mutiara Clinic, Sidoarjo. The research design is descriptive with the case type of study research. The results showed that the midwifery care provided to Mrs. A, starting from pregnancy, childbirth, postpartum, newborns, and family planning, went according to midwifery care standards. Conclusions after being given Continuity of Care midwifery care, the mother feels comfortable, the occurring complications can be resolved and detected since the beginning of pregnancy, the mother and baby received adequate and integrated care.

Comparative analysis of the parameters of local immunity of oral fluid and the duration of the course in children with systemic lupus erythematosus, juvenile scleroderma, juvenile dermatomyositis, juvenile idiopathic arthritis and systemic vasculitis

Immunoglobulins are considered to be the main factor of specific antimicrobial protection of oral tissues.The study was conducted on the basis of the University Children’s Clinical Hospital of the I.M. Sechenov First Moscow State Medical University of the N.F. Filatov Clinical Institute of Child Health, in the Department of Rheumatology. The study involved 316 children, with diseases: systemic lupus erythematosus (SLE), juvenile dermatomyositis (YDM), juvenile limited scleroderma (YOSD), juvenile systemic scleroderma (YSSD), juvenile idiopathic arthritis (JIA), systemic vasculitis (SV) and Behcet’s disease (BB) and were divided into age groups according to the duration of the course of the underlying disease. The analysis of the results revealed a decrease in the content of IgG, IgA, sIgA in saliva in children with rheumatic diseases in all age groups compared with the control group (children without somatic diseases). With the duration of the course of the disease up to 2 years, the most pronounced decrease in the content of IgG, IgA, sIgA in saliva was revealed, more than 4–10 times (p&lt;0.05), and with a duration of more than 2 years, a decrease of 2–3 times (p&lt;0.01), compared with the control group. The deficiency of these immunoglobulins shows that in children with rheumatic diseases, regardless of the nosology, there is a violation of the local immunity of the oral cavity, especially at the onset of the underlying disease (in groups up to 2 years of the duration of the course of the underlying disease), with pronounced autoimmune inflammation of tissues and blood vessels, and this is also facilitated by the reception, during this period of shock doses of glucocorticosteroids, cytostatics, immunosuppressors, which leads to severe inflammatory processes of the oral mucosa, periodontal and hard tissues of the teeth.

The effect of a new coronavirus infection on hemogram parameters in the early convalescence period of patients with coronary heart disease

Laboratory data, especially a general blood test, play an important role in the treatment of infectious diseases, including COVID-19. However, in patients with coronary heart disease (CHD) and COVID-19, a general blood test is rarely analyzed and is insufficient to fully assess an impact of the new coronavirus infection on patients with cardiac diseases. The aim of the study was to analyze a COVID-19 effect on hemogram parameters in the early recovery period of patients with coronary heart disease. The study was performed at the Kursk City Clinical Hospital for Emergency Medical Care in the years 2021–2022, which involved 58 mature-aged patients (45–59 years old) suffering from coronary heart disease who had a new coronavirus infection and 62 elderly patients suffering from coronary heart disease alone. Morning blood sampling was carried out from the forearm superficial veins into Vacutainer test tubes added with a coagulation activator. In elderly patients, 3–4 weeks after recovery, significant changes in red blood parameters persisted — a decline in the level of peripheral blood erythrocytes, hemoglobin and hematocrit. Elderly patients with coronary heart disease comorbid with a moderate new coronavirus infection, 3–4 weeks later had also higher count of leukocytes, neutrophils, segmented neutrophils and ESR level relative to comparison group. It should be noted that in the early convalescence period elderly patients with coronary heart disease and COVID-19 had significantly elevated ESR, which confirms ongoing sustained inflammatory process. After evaluating the information content according to the calculated Kullback informativeness assessment for analyzed general blood test parameters, it was found to peak for platelet and leukocyte counts as well as ESR level. Thus, among the analyzed indicators in the general blood test, it turned out that platelet and leukocyte count along with ESR level were most informative and of prognostic significance during early convalescent period of elderly patients with coronary heart disease comorbid with a new coronavirus infection, which are proposed to be used as biomarkers of early convalescent period.

Pregnancy Preparedness and Complication Preparedness of Pregnant Women in Prenatal Clinics of Tertiary Hospitals

This study assesses the level of Birth Preparedness and Complication Readiness (BPACR) among pregnant women attending antenatal clinics at a tertiary care center. Conducted through an analytical cross - sectional approach from August to October 2023 at Rajarajeswari Medical College Hospital, Bengaluru, it involved 194 participants who were 32 weeks gestation or more. The research utilized a questionnaire covering sociodemographic characteristics, knowledge of birth preparedness, and complication readiness, with data analyzed using descriptive statistics. Results indicated a low BPACR index with significant gaps in awareness and preparedness for childbirth and emergency situations. Only a fraction of participants had initiated antenatal care in the first trimester, and a majority were unaware of severe preeclampsia signs. The study underscores the need for enhanced education and awareness programs at both community and health center levels to improve birth preparedness and complication readiness among pregnant women.

Audit of antibiotic utilization patterns and practice for common eye infections at the ambulatory clinic of a teaching hospital in Ghana: Findings and implications

Background Antimicrobial resistance (AMR) is a serious public health issue which is exacerbated by increased inappropriate use of antibiotics for common eye infections. This cross sectional survey was to assess the appropriate use of antibiotics for eye infections in an ambulatory clinic in Ghana and possible determinants. Method The medical records of all patients who sought eye care between January 2022 to December 2022 and were prescribed antibiotics were extracted from the hospital’s electronic database. Descriptive, bivariate and multivariate analyses were then conducted. Results A total of 1925 patient medical records were extracted, whose median age was 40 years (IQR 26–69), and were mostly females (58.91%, n = 1134/1925). The eye condition commonly treated with antibiotics was bacteria conjunctivitis (33.51%, n = 645/1925). The most prescribed antibiotic was gentamycin (22.96%, n = 442/1925) followed by ciprofloxacin (16.78%, n = 321/1925). These were mostly topical dosage forms (82.13%, n = 1581/1925). Systemic antibiotics prescribed were mostly from the WHO ‘Access’ class (83.33%, n = 280/338). The appropriate choice of antibiotic prescribed was 42.44% (n = 817/1925) and this was positivity associated with age (p&lt;0.001), number of antibiotics prescribed (p &lt;0.001), the prescription of topical dosage forms (p &lt;0.001), and WHO ‘Access’ antibiotic class (p &lt;0.034). Conclusion The level of appropriateness of antibiotic prescriptions for eye infections was sub-optimal. Antimicrobial stewardship programs, including prescriber education on guidelines and prescription audit to address associated factors, must now be instigated in this hospital to improve future antibiotic use and prevent the rise of AMR.

Altieri modified Nesbit corporoplasty for the treatment of penile curvature: Comparison of local anesthesia vs loco-regional anesthesia on the clinical outcomes

Objective: To compare the safety profile and clinical outcomes of Altieri-modified Nesbit corporoplasty using two different anesthesia methods including spinal anesthesia and local anesthesia. Materials and methods: A total of 40 patients with congenital penile curvature (CPC) and Peyronie’s disease (PD) underwent Altieri-modified Nesbit corporoplasty. Group 1 (n = 20) received spinal anesthesia, and Group 2 (n = 20) received local anesthesia. The patients were categorized into age groups (&lt; 30 years, 31-45 years, 46-60 years, and 61-75 years) for analysis. Clinical outcomes, post-operative complications, hospital stay, pain levels, and other parameters were assessed. Results: The results showed that 2 patients (10%) reported postoperative complications, including headache, arterial hypotension, and penile foreskin necrosis from the spinal anesthesia group. Whereas, in the local anesthesia group, 1 patient (5%) reported scar phimosis. Further, post-operative pain was predominantly very mild, with 16 patients (80%) in the spinal anesthesia group and 14 patients (70%) in the local anesthesia group experiencing minimal discomfort. Age did not significantly impact hospital stay, post-operative intestinal disorders, constipation, lower urinary tract symptoms, voiding burning, or dysuria. Conclusions: Spinal anesthesia may lead to more post-operative complications and longer hospital stays compared to local anesthesia. Age does not significantly affect most clinical outcomes but can influence post-operative pain in patients receiving local anesthesia.

Significance of Initial Chest CT Severity Score (CTSS) and Patient Characteristics in Predicting Outcomes in Hospitalized COVID-19 Patients: A Single Center Study

The aim of this study is to examine the prognostic role of initial chest computed tomography severity score index (CTSS) and its association with demographic, socio-epidemiological, and clinical parameters in COVID-19 hospitalized patients. A retrospective study included patients who were hospitalized in the COVID Hospital of the Clinical Hospital Center Kosovska Mitrovica from July 2020 to March 2022. We compared patient characteristics and outcome of their hospital stay with values of CT severity score (mild, moderate, and severe form of the disease). Patients with severe disease were statistically significantly older, they treated more days, and they presented statistically significant highest mortality rate compared to mild and moderate forms. Smokers and obese were significantly more frequent among patients with higher CT, while vaccinated patients were more common among those with a mild form. Biochemical parameters at admission also showed statistical significance between the examined groups. We can conclude that by employing the initial CT severity score as the strongest predictor of mortality, it is possible to predict the outcome in hospitalized patients. A comprehensive examination of the patient upon admission, including determining the extent of inflammatory changes in the lungs using computed tomography, the levels of oxygen saturation, and other laboratory parameters, can assist doctors in making an adequate clinical evaluation and apply appropriate therapeutic protocols in the treatment of COVID-19.

Development of a triplex endpoint PCR assay for the detection of SARS-CoV-2: insights on cost-efficiency and method design.

Lower respiratory tract infections, including COVID-19, have a substantial global impact, making the development of diagnostic tests crucial. The study aimed to develop a new, accurate, fast, and cost-effective PCR-based detection method for SARS-CoV-2, applicable in limited settings and capable of detecting all current variants and potential future pathogens. The study was conducted between 2020 and 2022 at the molecular biology department of Mures County Clinical Hospital, Romania. Initially, pharyngeal and nasal secretions were collected and processed using the real-time qRT-PCR method for routine COVID-19 diagnosis. Ninety-two samples were randomly selected to develop the assay, including samples from different infection periods and negative controls. Complementary DNA (cDNA) was prepared from the selected samples, and the presence and integrity of the extracted RNA were evaluated by amplifying the GAPDH housekeeping gene. Primers for three specific viral genes (N, ORF1ab, and S) were designed, and their efficiency was evaluated using endpoint PCR and sequencing. Finally, the method was optimized and implemented as a one-step triplex PCR assay for routine diagnostic use. The molecular laboratory at the Mures County Clinical Hospital (MCCH) analyzed a total of 41,818 samples between June 2020 and December 2022. Among these samples, 26.15% tested positive for SARS-CoV-2, while 70.9% were negative and 2.95% were inconclusive or invalid. Three peaks of positive tests were observed in November 2020, April 2021, and February 2022. The study selected 92 preserved RNA samples for triplex-PCR assay development, validating the primers' specificity and confirming the quality of the nucleic acids. The comparative analysis showed the efficiency and accuracy of the endpoint reverse-transcription triplex-PCR method (RT-PCR), indicating its potential as a cost-effective alternative to real-time reverse-transcription PCR (qRT-PCR) in low-income countries with limited infrastructure for COVID-19 testing. This method has the potential to facilitate large-scale diagnosis of SARS-CoV-2 infections, allowing for rapid and appropriate therapeutic management and ongoing monitoring of patients. Additionally, the method can be easily adapted for the detection of other pathogens.

Relevance of Thyroid Microcarcinoma and Its Diagnosis

Microcarcinoma is a thyroid gland cancer with a size of less than 1 cm. The aim: To determine the frequency of microcarcinoma among malignant pathologies of the thyroid gland based on fine-needle aspiration biopsies (FNAB) data. Materials and Methods: A retrospective analysis of 2490 FNAB data was conducted under ultrasound control from 2007 to 01.07. 2024 at the Ternopil Regional Clinical Hospital. FNAB results were categorized into four groups: the first group – non-diagnostic results, the second – suspicion of thyroid cancer, the third – thyroid cancer, and the fourth – benign lesions. After the Bethesda system was introduced, FNAB classifications were based on this system. Results: Thyroid cancer was diagnosed in 186 cases (7.5%). Among these, macrocarcinoma was identified in 152 cases (81.7%) and microcarcinoma in 34 cases (18.3%). The peak incidence of microcarcinoma is observed in the 40-50 age, with approximately 90% of patients being women. Microcarcinomas in solitary nodules were found in 16 cases (47%); among multinodular goiters in 18 cases (53%). In 8 cases (23.5%), microcarcinoma was associated with larger thyroid cancers (multifocal process) and in 4 cases (11.8%) with benign nodules. In 6 cases (17.7%), microcarcinomas were associated with nodules suspicious for cancer. Conclusions: Indications for FNAB should be guided by the identified sonographic characteristics (solid echostructure of the nodule; hypoechogenicity; vertical orientation of nodules; indistinct margins of the nodule; presence of microcalcifications; regional cervical lymphadenopathy with signs of malignancy).

Assessing the impact of a dedicated referral and management algorithm in maternal hypothyroidism.

The significant risks of hypothyroidism during pregnancy can be mitigated through timely diagnosis and initiation of thyroxine to achieve a maternal euthyroid state. This study aimed to evaluate the efficiency of hospital endocrine services by assessing the rate of thyroxine commencement before the initial clinic appointment, the median gestational age at the first consultation, the rate of guideline-appropriate investigations, perinatal outcomes, and the proportion of referred patients who achieved their target thyroid-stimulating hormone (TSH) levels before and after implementing a dedicated referral and management pathway. A retrospective clinical audit was conducted using electronic medical records for the first fifty consecutive patients with hypothyroidism referred to the hospital clinic during two-time intervals: from April 1 to September 1, 2020 (pre-intervention) and from April 1 to September 1, 2021 (postintervention). Following the pathway implementation, there was no significant difference in the proportion of women with initially raised TSH who were prescribed thyroxine prior to the first clinic appointment (P=0.83). However, the first TSH measurement occurred earlier (median 5.5 vs. 6.5 weeks, P=0.011), and specialist reviews were conducted sooner (median 19 vs. 22 weeks, P=0.032). Significantly more women with elevated TSH underwent thyroid autoantibody testing postintervention (78% vs. 55.5%, P=0.035). There was no significant difference in perinatal outcomes. All women achieved their target TSH levels, with a median final TSH of 1.6 mIU/L (IQR: 1.2 to 2.3). While the proportion of referred patients achieving target TSH levels during pregnancy remained unchanged, certain measures of service efficiency improved. These included earlier TSH measurement, earlier endocrinologist review, and increased detection of thyroid autoantibodies.

No reimbursement policy and implantable loop recorders in the real world setting

Abstract Background Prolonged heart rhythm evaluation is indicated in patients with suspected arrhythmias. Routine electrocardiographic Holter monitoring is often associated with poor adherence and may lead to little to no clinically relevant findings. Implantable loop recorders (ILRs) are small, subcutaneous cardiac devices providing semi-continuous electrocardiographic recording. Despite strong evidence supporting their effectiveness, ILRs are yet to be fully reimbursed by the National Health Fund- the public insurer in Poland. Purpose We aimed to investigate the feasibility, as well as the diagnostic yield of ILRs in a real world setting of a tertiary cardiovascular center. Methods We retrospectively analyzed data of consecutive patients admitted for ILR implantation between March 2013 nad November 2023. Hospitalization and procedural costs were covered by the clinic's statutory and hospital funds and not by the National Health Fund, the public payer. All patients were remotely monitored for device follow-up. Baseline demographic characteristics, as well as data regarding observation period, clinical outcomes and safety were collected. Results Data for 51 ILR implants in 50 patients was assessed. Insertion success rate was 100% on first attempt with no complications. Mean age was 54,43 ±18,56 years old. 52,94% of patients were female. Coronary artery disease was present in 21,57% patients, hypertension in 50,98%, diabetes in 13,73%. The indications for ILR implantation were unexplained syncope (n= 42; 82,35%), palpitations (n= 16; 31,37%), ischemic stroke of unknown origin (n= 6; 11,76%), monitoring of ventricular arrhythmia (n= 2; 3,92%). Mean time between occurrence of first symptoms and ILR implantation was 80,86 ±112,95 months. Mean monitoring period was 1067,62 ±668,89 days. 23 (45,1%) patients had an actionable event detected. Mean time to clinical outcome was 190,34 ±514,85 days. Based on the obtained recordings, in 13 (25,49%) patients a cardiac electronic device was implanted and 6 (11,76%) underwent an electrophysiological procedure. Time to intervention was 435,17 ± 542,9 days and 338,8 ± 273,44 days, respectively. ILR prompted medication modification in 14 (27,45%) patients. Antiarrhythmic drugs were modified in 6 (11,76%) patients. Oral anticoagulation was initiated in 3 (5,88%) patients. Mean time to any pharmacotherapy modification was 654,68 ± 604,32 days. Skin infections occurred in 2 patients, leading to early device removal. Conclusions This is the first study to present a comprehensive evaluation of ILR patients in Poland, along with a substantial observation period. We report a high prevalence of treatable cardiac conditions in patients with previous unsuccessful diagnostic work up. In the light of the upcoming favourable changes in governmental healthcare policy, demonstrating evidence supporting ILR application in everyday clinical practice is crucial for advocating their wider utilization and reimbursement.

Correlation between vaccine hesitancy, vaccine reliability and perceptions of infectious diseases

Abstract Background Vaccine hesitancy is a delay in vaccine acceptance or refusal despite the availability of vaccination services. In recent years, the rise in vaccine hesitancy has attracted attention. This study aimed to evaluate the perception of vaccine hesitancy, vaccine safety, and infectious diseases among parents. Methods This cross-sectional study was conducted with 503 parents who applied to the pediatrics outpatient clinic of a university hospital. The questionnaire used in the study included questions on sociodemographic characteristics, factors related to vaccine hesitancy, The Vaccine Hesitancy Scale (VAS), the Vaccine Safety Scale (VSS), and the Perception Scale for Infectious Diseases (PPSID). Multivariate Linear Regression Analysis was used to find the variables associated with vaccine hesitancy. Results The mean age of the parents was 37.6±7.6 years. Parents’ scores on the ATS ranged from 17-85, with a mean score of 20.1±6.6 points. A moderate negative correlation was found between parents’ VAS and VSS scores, and between VAS and PPSID scores (r=-0.412, p &amp;lt; 0.001; r=-0.409, p &amp;lt; 0.001, respectively). According to the multivariate linear regression analysis the variables found to be associated with vaccine hesitancy, income status, maternal education level, child’s age group, having information about childhood vaccination schedule, child’s immunization status, the necessity of childhood vaccines, having sufficient information about the safety of vaccines, vaccine safety level, and infectious disease perception level were found to be significant predictors of vaccine hesitancy (F: 12,844, p ≤ 0.001, R2: 0.334). Conclusions This study determined that vaccine hesitancy was higher in families with lower income, who have not completed the schedule nor been vaccinated, doubt the necessity of vaccines to prevent infectious diseases, lack of knowledge about the reliability of vaccines, and whose children are still in primary school. Key messages • Health professionals have a critical role in reducing vaccine hesitancy. • It would be appropriate to plan face-to-face or online programs with parents.