Hospital-based Prospective Observational Study Research Articles

Antiseizure adverse drug reaction and associated factors among epileptic patients at Jimma Medical Center: a prospective observational study

A growing body of evidence suggests that adverse drug reactions (ADRs) are a major cause of morbidity and mortality in the healthcare system. Fifteen to twenty-five percent of patients with epilepsy discontinued antiseizure drugs (ASDs) within 6 months of therapy owing to intolerable adverse drug reactions. In Ethiopia, the prevalence of antiseizure adverse drug reactions and associated factors was not extensively conducted in advanced settings like Jimma Medical Centers. Hence, the objective of this study is to assess patterns of adverse drug reactions and associated factors among ambulatory epileptic patients at tertiary hospitals in Ethiopia. A hospital-based prospective observational study was spanned for 1 year. Two hundred ninety patients were consecutively recruited into the study from all epileptic patients attending the ambulatory clinic. Relevant data were collected through patient interviews and medical chart reviews. The causality assessment was done by using the Naranjo Probability Scale. Epi-Data manager version 4.6.0.4 was used for data entry and statistical analysis was performed by Statistical Package for Social Science version 25.0 (SPSS). Stepwise backward logistic regression analysis was done to identify factors that increase the risk of antiseizure adverse drug reactions. The mean (± SD) age of the participants were 29.91(± 11.26) years. The overall prevalence of ADR was 33.8% (95% CI 29.2–39.9%). A total of 110 adverse drug reactions were identified among 98 patients with an average of 1.12 per patient. ADRs were frequently reported with phenobarbital (52.04%) and phenytoin (34.70%). The commonly identified adverse drug reactions were epigastric pain (27.55%) and central nervous system drowsiness (23.46%). Comorbidity (AOR = 5.91, 95% CI (2.14–16.32), seizure-free period of fewer than 2 years (AOR = 1.94, 95% CI (1.18–3.19), and polytherapy (AOR = 1.35, 95% CI (1.80–2.26) were significantly associated with adverse drug reactions. This trial had a comparatively high percentage of adverse medication reactions. Adverse medication reactions were more common in patients with polytherapy, comorbidities, and seizure-free durations less than two years. Therefore, medical practitioners should advise patients who exhibit these traits on how to reduce or avoid bad drug responses or provide comfort in the event of small incidents.

Clinical profile of children with metabolic liver diseases presenting in a tertiary care hospital of Eastern India

Clinical profile of children with metabolic liver diseases presenting in a tertiary care hospital of Eastern India

Mutational Profiling by Next-Generation Sequencing in Patients with Metastatic Non-Small Cell Lung Carcinoma: Our Experience

Introduction According to GLOBOCAN 2020, overall lung cancer is the second most common cancer in both sexes (11.4%) accounting for highest cancer-related mortality (18%).1 Adenocarcinoma subtype of non-small cell lung cancer (NSCLC) is the most common subtype and is divided into further molecular subtypes based on oncogenic driver mutations. Overall survival in these patients is poor with the use of conventional platinum-based double chemotherapy and various recent studies on targeted therapy studies have showed improved survival. Therefore, broad panel-based testing like next-generation sequencing (NGS) is strongly recommended to identify these targetable driver mutations. Aims and Objectives The aim of this study was to evaluate the mutational profile in patients with metastatic NSCLC (mNSCLC) by NGS method. Materials and Methods A hospital-based prospective observational study done on 88 patients under the Department of Medical Oncology, State Cancer Institute during a period of 1 year. All patients above 18 years of age diagnosed as mNSCLC having Eastern Cooperative Oncology Group performance status 0 to 2 and evaluated for mutational profiling by NGS method were included. Five gene panel tests including endothelial growth factor receptor (EGFR), echinoderm microtubule-associated protein-like 4 and anaplastic lymphoma kinase (EML4-ALK), BRAF, mesenchymal epithelial transition (MET), and ROS proto-oncogene 1 (ROS1) were used. Results and Observations Majority of mNSCLC cases were in the age group of 41 to 50 years (n = 30, 34.1%) with average age at presentation being 53.74 years. Male: female ratio was 1.14:1 and most patients were nonsmokers. Adenocarcinoma subtype of mNSCLC cases had the highest mutational burden (n = 55, 62.5%). EGFR (n = 32, 56.14%) was the most common mutation followed by EML4-ALK (n = 19, 33.33%). Most common EGFR mutation was in Exon 19. Other rare mutations were ROS1 (n = 4), BRAF V600E (n = 1), and MET (n = 1). Skeleton was the most common site of metastasis across all driver mutations. Conclusion EGFR and EML4-ALK were the commonest targetable mutations detected in the study. As there is very limited data from North Eastern region of India regarding mutational status in mNSCLC, this study opens up possibilities for further studies targeting multiple mutations to give us more comprehensive understanding of the mutational landscape of mNSCLC in this era of precision medicine.

Epidemiological and Clinical Profile of Hand, Foot, and Mouth Disease in Children in a Tertiary Care Center in Jammu.

Background Hand, foot, and mouth disease (HFMD) is a viral illness commonly seen in children under five years of age, characterized by typical manifestations such as oral lesions and rashes on the hands and feet. Coxsackievirus A-16 (CV-A16) and Enterovirus A-71 (EV-A71) are the major etiological agents of this disease. Over the past two decades, there have been several outbreaks of HFMD all across India. As there is no chemoprophylaxis available for the disease, it becomes even more significant to conduct regular research and surveillance for HFMD. Aim and objective To observe the clinico-epidemiologicalprofile along with constitutional symptoms in HFMD patients attending pediatric OPD. Methods This hospital-based prospective observational study was conducted in the Post Graduate Department of Pediatrics, Acharya Shri Chander College of Medical Sciences and Hospital (ASCOMS & H), Sidra, Jammu and Kashmir, India, oversix months from April to September 2023. A total of 132 children with symptoms of HFMD visited the pediatric OPD. After using inclusive and exclusive criteria, we selected a sample size of 112 children with HFMD. The descriptive data were expressed in terms of percentages and proportions, and their graphical representation was done using MS Excel (Microsoft Corporation, Redmond, Washington, United States). Results Among the 112 HFMD patients examined, the highest peak was seen in August, followed by another one in September. Most of the cases were seen in the age group of zero to three years, and it was observed that there wasa linear fall in the number of cases with the increase in age. Nearly 61% of cases were male, showing a slight male preponderance. Vesiculopapular rash on the hand and foot was the most common clinical characteristic, whereas painful deglutitionwas noted to be the most common constitutional symptom in HFMD patients. About 27% had a positive family history, and nail changes post-recovery were present in 1.79% of cases during their regular follow-ups. Conclusions This study reveals that HFMD cases surged in August and September, with a history of contact in one-fourth of cases. Disease is seen more commonly in children under three years of age, and the incidence of cases decreases with the increase in age. The illness is usually contagious and can spread quickly; therefore, more awareness programs should be done toeducate parents and promote hygiene to prevent contact cases.

Comparison of Hemopoietic Biochemical Parameters in the First, Second, and Third Trimester of Pregnant Females Attending a Tertiary Care Hospital of Western Rajasthan.

Pregnant women constitute a high-risk group for nutrient deficiency anemia which may be associated with detrimental effects on maternal and infant health. This study aimed to assess and compare hematological and biochemical changes across trimesters in pregnant women, considering parameters such as hemoglobin, serum iron, unsaturated iron-binding capacity (UIBC), total iron-binding capacity (TIBC), ferritin, vitamin B12, and folic acid. The research sought to identify mean value differences, correlations, and potential implications for maternal healthcare practices. A hospital-based prospective observational study was conducted, involving 60 primigravida women with singleton pregnancies. The subjects were assessed during the first, second, and third trimesters. Biochemical parameters were assessed using standard methods, and statistical analysis was performed to identify significance and correlations. The study revealed a significant decline in hemoglobin, serum iron, ferritin, vitamin B12, and folic acid as pregnancy advanced. Hemoglobin levels decreased from 11.40 g/dl (first trimester) to 10.43 g/dl (third trimester). Serum iron exhibited a decline from 109.73 µg/dl (first trimester) to 94.03 µg/dl (third trimester). Serum ferritin decreased from 24.93 ng/ml (first trimester) to 18.21 ng/ml (third trimester). Vitamin B12 levels dropped from 255.92 pg/ml (first trimester) to 92.13 pg/ml (third trimester). Folic acid levels decreased from 13.82 ng/ml (first trimester) to 11.77 ng/ml (third trimester). UIBC and TIBC concentrations increased progressively across trimesters. Statistical evaluations confirmed the significance of these trends. The coefficient of correlation indicated positive relationships between hemoglobinand serum iron, ferritin, folic acid, and vitamin B12.Positive correlation between serum iron and ferritin, vitamin B12, and negative with folic acid. Serum ferritin negatively correlated with vitamin B12 and folic acid. Serum folic acid and vitamin B12 are positively correlated. The findings emphasize the dynamic nature of hematological and biochemical changes during pregnancy. The observed trends have profound implications for maternal healthcare practices, urging targeted interventions, early monitoring, and supportive supplementation. Recognizing these variations contributes to the optimization of health outcomes for both mother and child.

A Study Comparing Centchroman and Evening Primrose Oil in the Treatment of Benign Breast Disease

ABSTRACT Introduction: Females seeking medical attention at breast clinics commonly present with nonmalignant breast conditions, including nonspecific breast pain or distinct masses like fibroadenomas. Due to its variability, it may be difficult to quantify breast pain. The purpose of the research was to compare centchroman and evening primrose oil to identify a cost-effective, secure, and efficient treatment for benign breast disease. Material and Methods: In this prospective hospital-based observational study, 100 breast diseases with or without lumpiness for 1 year were included and divided into two groups with 50 cases each, Group-A (Centchroman) and Group-B (Evening primrose oil). Results: Centchroman exhibited a significantly greater treatment response for alleviating pain-free mastalgia compared to evening primrose oil. Additionally, centchroman showed an excellent response (P < .05). Among participants with mastalgia, centchroman significantly reduced the number of mastalgia patients with tender nodularity post-treatment (P = .035) than evening primrose oil. On the basis of fibroadenoma, partial and complete response was significantly seen in higher number of cases in the centchroman group (P = .007). Conclusion: Centchroman therapy demonstrates that the treatment for benign breast disease is safe, effective, and economical.

A study on risk factors, clinical profile, spectrum of comorbidities in children with cerebral palsy and efficacy of early intervention by rehabilitation units on neurodevelopmental outcome in these children

Background: Cerebral palsy (CP) is one of the leading causes of childhood disability worldwide with the greatest burden found in developing countries. This study is undertaken as there is limited data available regarding CP children in the Andhra Pradesh region. This study was done to evaluate the clinical spectrum, risk factors, and comorbidities associated with CP that will help in better understanding of etiology and for early intervention by District early intervention centers. Methods: This is a hospital-based prospective observational study conducted over 18 months among children from 6 months to 5 years of age visiting a tertiary care hospital. Results: Among 65 enrolled children majority of the children (74%) were between 2 to 5yrs with a male-to-female ratio of 4:1. Consanguinity was observed in 33.8% and the majority were from rural areas (71%). The most frequent presenting complaint was delayed milestones (33.4%). 67.6% of subjects were born at term with the most common risk factor being birth asphyxia (27.6%). The most common type was spastic CP (87%) in whom the Developmental quotient (DQ) was severely affected (56.7%) and 32.3% of children belong to GMFCS level III. Comorbidities like feeding difficulties and GERD (47.6%), visual problems (24.8%), and hearing problems (30%) were commonly associated. At the time of enrollment, only 21.5% of children had normal nutritional status which improved to 30.7% after 12 months of follow-up. Conclusions: Efforts should be made to increase awareness among parents regarding the availability of encouraging utilization of the services to relieve the burden of disorder.

Establishment of Labor Epidural Analgesia Service and its Assessment: An Experience in a Hospital of a Middle-Income Country.

Even though the idea of painless birth is more than 100 years old, it is still underrepresented in some parts of the world despite progress in science, education, anesthesia, spinal and epidural needles, development of catheters, new drugs, and infusion pumps. Maternal care should basically be the safety of the patient (in this case two patients) and also provide all kinds of protection in the form of a multidisciplinary team with an anesthesiologist, especially when it comes to pain therapy and anesthesia for women in labor. In this direction, our hospital departments with low or moderate volume of annual births made the decision to educate ourselves for painless childbirth and contribute more to the care of women in labor. The enthusiasm and dedication of our clinical team prevailed and today we have a high standard of labor epidural service. The aim of this study was to evaluate the establishment of the epidural labor service by comparing the effects of epidural analgesia on labor pain and the course of labor. The secondary objectives were to compare satisfaction with epidural analgesia and the impact of epidural analgesia on the delivery mode. This was a prospective observational hospital-based study conducted on100 patients after the establishment of epidural service. Parturients who were signed to receive epidural analgesia formed Group A and parturients who did not request epidural analgesia formed Group B. All parturients are induced in the delivery room with a Bishop score of 5 or higher. Pain intensity measured through the visual analog scale of pain (VAS score) was significantly lower in Group A (n = 46) compared to Group B (n = 50) at measured points of time (p<0.001). There was a fall in the mean VAS score in Group A from 7.94 to 3.86 within 20 minutes of the bolus dose and starting a continuous infusion.Labor progress according to the Bishop score and till the end of the second stage of labor, or to the transfer to the operating theatre, according to the monitored time in Group A was 176 minutes and it was lower in Group B with 155 minutes; however, by test of linearity we do not gain significance(p = 0.2). There were eight parturients in each group(17% vs 16%) who were indicated for surgical delivery. According to Pearson's correlation test for the outcome of labor between parturients receiving epidural analgesia and parturients without epidural analgesia (p = 0.8), we cannot say that epidural analgesia in labor is correlated with the outcome of surgical delivery. Establishing a new hospital procedure such as an epidural painless service for childbirth in low or moderate-volume settings of annual births is very challenging. By evaluating epidural labor services in our hospital, we created the best environment for continuous improvement and long-term efficacy and safety of our analgesic techniques aimed at providing excellent care to mothers and their babies.

LATCH score: a tool for identification and correction of breastfeeding problems in a tertiary care hospital of North Karnataka

Background: Breastfeeding, a vital childhood intervention, faces challenges despite being a natural process. Factors such as maternal confidence, latching issues, breast pain, perceived milk insufficiency, and inadequate encouragement contribute to early discontinuation. Assessing breastfeeding in postpartum mothers prior to discharge is important for successful breastfeeding. The LATCH charting system designed by Jensen et al was used to assess the score. Objectives were to determine early breastfeeding problems using LATCH score and to study the impact of breastfeeding supportive measures on LATCH score. Methods: Hospital-based prospective observational study was conducted among 100 mothers who delivered in hospitals attached to Mahadevappa Rampure Medical College, Kalaburagi. The LATCH score was assessed twice, first within 24 hrs after birth and second 48 hrs after intervention. Results: Good LATCH score was found among the rural mothers, multiparous mothers and those who had a normal vaginal delivery. After providing breastfeeding support, a majority (81%) of the mothers transitioned from poor or moderate to a good LATCH score group. The overall mean LATCH score increased from 5.83±1.64 to 9.31±1.5 following intervention. Improvement was seen in all the individual components of LATCH. Conclusions: This LATCH assessment tool can identify mothers and infants who are at risk of early breastfeeding cessation and serve as a guide to initiate appropriate intervention.

Early outcomes of minimally invasive hybrid coronary revascularization

Background: Coronary artery bypass graft (CABG) surgery has been the gold standard for the treatment of coronary artery disease over the years. It is recommended for patients with multi-vessel coronary artery disease, left main disease, diabetics, severe left ventricular dysfunction, unsuitable anatomy for percutaneous coronary intervention (PCI), and failed PCI. The usage of the left internal mammary artery (LIMA) in the CABG to the left anterior descending (LAD) artery has proven to be superior compared to PCI. Minimally invasive hybrid coronary revascularization (MIHCR) is gaining growing interest. Methods: This is a hospital-based prospective observational study with 200 patients followed up for a period of 30 days. This study aims to assess the early outcomes of MIHCR in the Indian population. Results: The 30-day mortality was comparable to other studies, and the number of days in the ICU and hospital stay was shorter than the routine CABG. There was no incidence of a wound infection or stroke. Blood product usage and the need for repeat revascularization and re-exploration were less. The short-term outcomes were promising. Conclusions: MIHCR has excellent short-term results and is safer than conventional OPCABG, as it is less invasive and avoids midline sternotomy. It also reduces the incidence of stroke and lesser usage of blood products, promoting early return of patients to their routine activities.

Validity of BiliDx as a point-of-care bilirubin measurement device to diagnose and monitor neonatal jaundice at Muhimbili National Hospital, an observational study

BackgroundNeonatal jaundice is a condition caused by elevated levels of bilirubin in the bloodstream. Laboratory determination of serum bilirubin concentration by total serum bilirubin (TSB) test is still considered as gold standard for clinical guidance and practice. In developed countries, diagnosis of neonatal jaundice is shifting towards point-of-care medical devices. BiliDx is a device developed to allow a fast, blood-based determination of bilirubin levels at the point of care. This study aimed to determine the accuracy of the BiliDx device relative to a standard laboratory total serum bilirubin to diagnose and monitor jaundice among neonates admitted at Muhimbili National Hospital (MNH).Material and methodologyThis was a prospective hospital-based observational study conducted at the Neonatal Ward – MNH, Dar-es-Salaam, Tanzania from November 2022 to January 2023. A total of 180 neonates admitted at the neonatal ward with jaundice and whose parents consented were enrolled in the study. Blood samples were collected; 2 ml of venous blood into the vacutainer bottle for standard laboratory measurement of total serum bilirubin (TSB) and 25µL blood collected into a transfer pipette tube and applied to BiliDx. STATA version 15.1 was used for data analysis.ResultsOut of 180 neonates, 39.4% (71/180) had birth weight between 1500 − 2499.9 g, approximately 2/3rd (120/180) were preterm, 92/180 (51.1%) were males and 100/180 (55.6%) were undergoing phototherapy treatment the moment sample taken. The mean bilirubin concentration was 92 mmol/l for BiliDx and 118 mmol/l for standard laboratory TSB. The minimum and maximum values obtained with BiliDx were, 3.4 and 427.5 mmol/l respectively, compared with 10.7 and 382.1 mmol/l using standard laboratory TSB. A linear relationship and correlation coefficient of 0.8408 (p = 0.000) between BiliDx and standard laboratory TSB was found. The regression analysis showed the presence of constant error [coefficient of BiliDx/slope = 0.91, 95% CI (0.82–0.99), p = 0.000] and random error exclusively [coefficient of constant/y-intercept = 48.52, 95%CI (37.70-59.34), p = 0.000]. The Bland–Altman plot showed an acceptable mean difference of 39.1mmol/l, limits of agreement of -48.3mmol/l to 126.4mmol/l, and 179 points (179/180 = 99.4%) lying inside the limits of agreement.ConclusionThe results support the use of BiliDx for rapid and accurate testing of elevated levels of bilirubin in the bloodstream among neonates since 99.4% of the differences between BiliDx and standard laboratory TSB lie between the lines of agreement.

Factors Contributing to Negative Outcomes Associated with Medications and Drug-Related Problems in Kidney Replacement Therapy-A Hospital-Based Prospective Observational Study.

Negative outcomes associated with medications (NOM) and drug-related problems (DRP) significantly impact individuals with kidney replacement therapy (KRT) given the complexities of managing kidney disease and associated comorbidities. The present study aims to assess the frequency of NOMs/DRPs among KRT patients and identify contributing factors. A cross-sectional study was conducted at Virgen de las Nieves University Hospital (Granada, Spain), involving 117 outpatient adults with KRT. Data were collected from February 2021 to July 2023 using electronic records, semi-structured interviews (Dáder Method), and discussions with nephrology specialists. NOMs/DRPs were identified following treatment guidelines. Binary logistic regression was used to determine associated factors (p-value < 0.05). Across 117 patients, 2436 NOMs and 3303 DRPs were identified, averaging 20.82 NOMs and 28.23 DRPs per patient. Prevalent NOMs included untreated conditions (58.95%), quantitative ineffectiveness (35.43%), and non-quantitative safety problems (5.13%). Dominant DRPs were undertreated conditions (37.63%), wrong dose/posology/length (33.00%), risk of adverse drug reactions (ADR) (16.14%), and non-adherence (6.87%). Patients with ADR, undertreated conditions, and anemia were associated with quantitative ineffectiveness. Risk of ADR and vitamin D deficiency/insufficiency correlated with non-quantitative safety problems. KRT patients exhibited a substantial prevalence of NOMs/DRPs. Further research is needed to deepen our understanding of these complexities for improved patient care.

Clinical characteristics and outcomes of traumatic brain injury in patients admitted to surgical ward of Jimma Medical Center, Southwest Ethiopia: a prospective observational follow-up study

ObjectiveTo assess the Clinical Characteristics and Outcomes of Traumatic Brain Injury in Patients Admitted to the Surgical Ward of Jimma Medical Center, Southwest Ethiopia from January to July 2022.Design and...

IR808@MnO nano-near infrared fluorescent dye’s diagnostic value for malignant pleural effusion

BackgroundMalignant pleural effusion is mostly a complication of advanced malignant tumors. However, the cancer markers such as carbohydrate antigen 125 (CA 125), carbohydrate antigen 15-3 (CA 15-3), carbohydrate antigen 19-9 (CA 19-9), and cytokeratin fragment 21-1 (CYFRA 21-1) have low sensitivity and organ specificity for detecting malignant pleural effusion.Research questionIs IR808@MnO nano-near infrared fluorescent dye worthy for the diagnosis in differentiating benign and malignant pleural effusions.Study design and methodsThis experiment was carried out to design and characterize the materials for in vitro validation of the new dye in malignant tumor cells in the A549 cell line and in patients with adenocarcinoma pleural effusion. The dye was verified to possess tumor- specific targeting capabilities. Subsequently, a prospective hospital-based observational study was conducted, enrolling 106 patients and excluding 28 patients with unknown diagnoses. All patients underwent histopathological analysis of thoracoscopic biopsies, exfoliative cytological analysis of pleural fluid, and analysis involving the new dye. Statistical analyses were performed using Microsoft Excel, GraphPad Prism, and the R language.ResultsThe size of IR808@MnO was 136.8 ± 2.9 nm, with peak emission at 808 nm, and it has near-infrared fluorescence properties. Notably, there was a significant difference in fluorescence values between benign and malignant cell lines (p < 0.0001). The malignant cell lines tested comprised CL1-5, A549, MDA-MB-468, U-87MG, MKN-7, and Hela, while benign cell lines were BEAS-2B, HUVEC, HSF, and VE. The most effective duration of action was identified as 30 min at a concentration of 5 μl. This optimal duration of action and concentration were consistent in patients with lung adenocarcinoma accompanied by pleural effusion and 5 μl. Of the 106 patients examined, 28 remained undiagnosed, 39 were diagnosed with malignant pleural effusions, and the remaining 39 with benign pleural effusions. Employing the new IR808@MnO staining method, the sensitivity stood at 74.4%, specificity at 79.5%, a positive predictive value of 69.2%, and a negative predictive value of 82.1%. The area under the ROC curve was recorded as 0.762 (95% CI: 0.652–0.872). The confusion matrix revealed a positive predictive value of 75.7%, a negative predictive value of 75.6%, a false positive rate of 22.5%, and a false negative rate of 26.3%.InterpretationThe IR808@MnO fluorescent probe represents an efficient, sensitive, and user-friendly diagnostic tool for detecting malignant pleural fluid, underscoring its significant potential for clinical adoption.

Antimicrobial Use-Related Problems Among Hospitalized Pediatric Patients: A Prospective Observational Study.

Antimicrobials are among the most commonly misused medications, leading to antimicrobial resistance, and therefore demand more attention. There are limited studies documenting "antimicrobial use-related problems" in developing countries, especially in pediatric patients. This study aimed to evaluate the prevalence of antimicrobial use-related problems and risk factors among hospitalized pediatric patients. A hospital-based prospective observational study was conducted in Ayder comprehensive specialized hospital (ACSH) in the Tigray region, Ethiopia. The participants of the study were pediatric patients aged ≤15 years who were admitted with a diagnosis of infectious disease between September 2019 and November 2019. A total of 232 pediatric patients were included in the study. Of these, 59.5% of the patients were male and the mean age (SD) of the patients was 5.8 (5.2) years. Of the 232 patients surveyed, a total of 177 antimicrobial use-related problems were identified. One or more antimicrobial use-related problems have occurred in more than half of the patients (53.9%). The commonest antimicrobial use problems were unnecessary antimicrobial therapy (22.8%) followed by need additional antimicrobial therapy (16.4%). In a multivariate logistic regression model, patients with comorbidities (Adjusted odds ratio (AOR): 1.84, 95% confidence interval (CI): 1.04-3.27) and hospital stays exceeding one week (AOR=1.88, 95% CI: 1.08-3.26) were predictors of antimicrobial use-related problems. Antimicrobial use-related problems were found in a significant proportion of pediatric patients. Addressing these issues necessitates collaborative efforts, emphasizing targeted education, strengthened antimicrobial stewardship, ensuring responsible antimicrobial use and enhancing pediatric care.

Assessing Treatment Efficacy and Determinants of Outcome in Isoniazid Mono-resistant Tuberculosis Patients: A Prospective Observational Study in Gujarat

Introduction: There is a high number of isoniazid-resistant tuberculosis (TB) in India; estimates imply that over 25% of TB patients there are isoniazid-resistant. Hence, the study aimed to evaluate the effectiveness of therapy for patients with isoniazid-mono-resistant TB and the negative effects of the H-mono-resistant TB Regime. Materials and Methods: It was a hospital-based prospective observational study from September 2021 to August 2022. Hence, 100 patients diagnosed with isoniazid mono-resistance TB enrolled in this study. After obtaining the prior informed consent of all patients willing to approve the collection and publication of their data, including extensive clinical history and radiological, microbiological, and biochemical investigations, this study included all diagnosed cases of isoniazid mono-resistant TB. A descriptive statistical analysis was done for continuous and categorical variables. Differences in characteristics between participants were tested with logistic regression and cross-tabulation. P &lt;0.05 was considered significant. Results: Among 100 patients participated, their mean age was 50.8 ± 3.2 years. About 72 (72%) participants have successful treatment outcomes (cure). Only about 25 (25%) patients had minor adverse drug reactions. Body mass index (16.6 [3.6–74]), substance addiction history (9.5 [3.3–26.9]), previous history of TB (9 [3.3–24.0]), type of lesion (5.3 [1.6–17]), and extent of the lesion (2.6 [1.03–6.07]) in chest X-ray were associated statistically with the treatment outcome. Conclusion: The findings suggest that the H-mono-resistance regime is generally well-tolerated, with only a small percentage of patients experiencing nonserious adverse drug reactions, and the overall successful treatment outcome in H-mono patients was 72%. The study also highlights the importance of monitoring drug resistance patterns, particularly for levofloxacin and moxifloxacin, and the need for effective treatment regimens for isoniazid mono-resistant pulmonary TB.

Study of Glycemic Variability in Well-controlled Type 2 Diabetic Patients Using Continuous Glucose Monitoring System.

The world has changed tremendously for patients suffering from diabetes mellitus with the development of cutting-edge technologies like continuous glucose monitoring and flash glucose monitoring systems. Now, the details of constant fluctuations of glucose in their blood can be monitored not only by medical professionals but also by patients, and this is called glycemic variability (GV). Traditional metrics of glycemic control measurement, such as glycated hemoglobin (HbA1c), fail to reflect various short-term glycemic changes like postprandial hyperglycemia and hypoglycemic episodes, paving the way to the occurrence of various diabetic complications even in asymptomatic, well-controlled diabetic patients. This need for advanced management of diabetes and effective monitoring of these swings in blood glucose can be met by using a continuous glucose monitoring system (CGMS). To evaluate the extent of GV in well-controlled type 2 diabetes mellitus (T2DM) patients using a flash CGMS and to assess the correlation between GV and HbA1c. A hospital-based prospective observational study was carried out from May 2020 to Oct 2021 at the Department of Medicine, SMS Hospital, Jaipur, Rajasthan (India), after approval from the Ethics Committee of the institution. A total of 30 patients with well-controlled T2DM (HbA1c was ≥6.5, but ≤7.5) were included in the study using simple random techniques after written informed consent from patients. Patients were studied for glycemic excursions over a period of 7 days by using FreeStyle® Libre Pro™, which is a flash glucose monitoring system. The CGM sensor was attached to the left upper arm of the patient on day 0 and removed on day 7. The data recorded in the sensor was then retrieved using pre-installed computer software and analyzed using standard CGM metrics like standard deviation (SD), percentage coefficient of variation (%CV), time above range (TAR), time below range (TBR), and time in range (TIR), out of which %CV was used to quantify GV. %CV has been used to cluster patients into four cohorts from best to worst, namely: best/low CV ≤ 10%, intermediate CV from 10 to 20%, high CV from 20 to 30%, and very high CV of >30%. Scatterplots are used to establish correlations between various parameters. Data from a total of 30 patients were analyzed using CGMS and thus used for calculating standard CGM metrics; glucose readings every 15 minutes were recorded consecutively for 7-day periods, making it a total of 672 readings for each patient. Interpreting the CGM data of all 30 patients, the following results were found: the mean blood glucose of all cases is 134.925 ± 22.323 mg/dL, the mean SD of blood glucose of all cases is 35.348 ± 9.388 mg/dL, the mean of %CV of all cases is 26.376 ± 6.193%. CGM parameters of time are used in the form of percentages, and the following results were found: the mean of TAR, TBR, and TIR is 14.425 ± 13.211, 5.771 ± 6.808, and 82.594 ± 12.888%, respectively. Clustering the patients into cohorts, the proportion of patients exhibiting best/low %CV (10%) is 0, intermediate %CV (10-20%) is 16.67% (five out of 30 patients), high %CV (20-30%) is 50% (15 out of 30 patients) and very high %CV (>30%) is 33.33% (10 out of 30 patients). Also, there is no significant correlation found between HbA1c and %CV (ρ = 0.076, p-value = 0.690); a significant negative correlation was found between %CV and TIR (ρ = -0.604, p < 0.001S); a positive correlation of %CV with TAR and TBR is significant (ρ = 0.816, p-value of <0.001). Using a flash CGMS device and considering %CV as the parameter and primary measure of GV, the study demonstrated the overall instability of a person's glycemic control, making note of unrecognized events of hypoglycemia and hyperglycemia in asymptomatic well-controlled T2DM patients, revealing the overall volatile glycemic control. The most important finding of this study is that even those diabetics who are considered well-controlled experience a great degree of GV as assessed by CGM-derived metrics. This study also demonstrated that there is no significant correlation between HbA1c and GV, suggesting that patients may not have optimal control of their diabetes despite having "normal HbA1c" values; hence, GV can be considered an HbA1c-independent danger factor, having more harmful effects than sustained hyperglycemia in the growth of diabetic complications. So, by using CGM-derived metrics, the measurement of GV has the potential to complement HbA1c data. In this manner, a more comprehensive assessment of glycemic excursions can be provided for better treatment decisions, thereby facilitating optimal glycemic control, which is essential for reducing overall complications and promoting good quality of life.

Rising prevalence of gestational diabetes mellitus and its associated risk factors in Makurdi, North-Central Region of Nigeria.

The disease burden of gestational diabetes mellitus (GDM) in sub-Saharan African region have been on the rise. Proper assessment of current prevalence of GDM may inform policy changes and management approach for improved care delivery. To determine the current prevalence of Gestational Diabetes Mellitus (GDM) and evaluate its major risk factors amongst pregnant women in Makurdi, North-Central Nigeria. This was a multi-center hospital-based prospective observational study. Maternal characteristics and clinical risk factors for GDM in a cohort of 281 pregnant women at 9 to 16 weeks gestational age was evaluated. The one-step 75g oral glucose tolerance test (OGTT) was carried out at 24 to 28 weeks of gestation. Of the 356 women recruited, 281 (79.8%) completed the study. The GDM prevalence in the cohort was 16.7%. Increased early pregnancy BMI (adjusted OR = 1.154, 95% CI = 1.080 - 1.233, p<0.001) and presence of family history of diabetes mellitus (adjusted OR = 0.482, 95% CI = 0.233 - 0.997, P<0.05) were independent risk factors for GDM in the cohort. Increasing maternal age and early pregnancy BMI amongst other possible reasons, may account for the rising prevalence of GDM in the region.

Shigella as a Cause of Diarrhea Hospitalization in Children Under Five: Evaluation by Conventional and Molecular Methods.

Shigella is an important cause of diarrhea in children under five, often missed by conventional laboratory methods. Blood in stools has always been a syndromic indicator for Shigella diarrhea, but most cases present with watery diarrhea without blood. This study aimed to determine the frequency of Shigella detected by molecular and conventional methods in children under five. Additionally, we aimed to study the clinical profile and outcome of children with Shigella diarrhea managed as per current diarrhea treatment guidelines. In this hospital-based prospective observational study, stool samples from 150 children (age range: one month to five years) with acute diarrhea (duration < seven days) were subjected to routine microscopic examination, stool culture, and DNA extraction. The extracted DNA from stored stool samples was subjected to polymerase chain reaction (PCR) amplification using a specific primer for the invasion plasmid antigen Hgenesequence (ipaH) gene at 424 bp. Results were interpreted in the context of the percentage of isolation of Shigella by molecular (PCR) and conventional methods (stool microscopy and culture) and the follow-up outcome in terms of recurrence of diarrhea or dysentery and growth faltering over three months after discharge. Shigella infection was diagnosed in stool samples by PCR from 13 (8.7%) children, whereas it was isolated by conventional stool culture in only one (0.7%) child. The sensitivity of culture was only 7.7% against PCR for the diagnosis of Shigella infection, whereas blood in stools had a sensitivity of 15.4%. The majority of Shigella PCR-positive cases (11 out of 13) presented with non-bloody diarrhea. None of the evaluated clinical predictors had a significant association with the Shigella infection. No statistically significant difference was found between PCR-positive and PCR-negative children at the end of follow-up (P>0.05). The majority of children with Shigella infection present with watery diarrhea rather than bloody diarrhea, and a history of blood in stools is a poor marker for the diagnosis of shigellosis. The diagnostic performance of stool culture is also very low compared to stool PCR for the diagnosis of Shigella diarrhea.

Promoting Patient Safety: Exploring Device-Associated Healthcare Infections and Antimicrobial Susceptibility Pattern in a Multidisciplinary Intensive Care Units.

Device-associated healthcare infections are among the prevailing threats to patient safety worldwide. They constitute the third most common adverse event during healthcare delivery, resulting in heightened morbidity, mortality, and healthcare costs. Patients in intensive care units (ICUs) are at increased risk for device-associated healthcare infections. Focused active surveillance is a crucial measure for assessing the prevalence of healthcare-associated infections and controlling the transmission of pathogens, ultimately contributing to the establishment of quality outcome indicators.This study aimed to investigate and establish the baseline rates of healthcare-associated infections associated with medical devices in adult multidisciplinary ICUs within a tertiary care institute. This hospital-based prospective observational study was conducted in two adult ICUs of atertiary care institute in Central India over nine months. Targeted active surveillance for three device-associated health care infections namely central line-associated bloodstream infection(CLABSI), catheter-associated urinary tract infection (CAUTI), and ventilator-associated event (VAE)was conducted as per the Center for Disease Control (CDC)/National Healthcare Safety Network (NHSN) 2016 surveillance definitions and criteria. Pathogens associated with device-associated healthcare infections were identified and their antimicrobial susceptibility profile was studied. During the study period, a total of 5,773 patientdays were investigated. Of1,270patients, 28 episodes of device-associated healthcare infectionswere detected in 26 patients, this suggests a collective occurrence of five device-associated healthcare infections for every 1,000 patient days in the ICUs. The device utilization ratios of the central line, mechanical ventilator, and urinary catheters were 0.33, 0.27, and 0.68, respectively. VAE, CLABSI, and CAUTI rates were 8.92, 5.68, and 0.76 per 1,000 device days, respectively. The most common pathogenisolated from device-associated healthcare infections wasKlebsiella pneumoniae (39%) followed by Acinetobacter baumanii (22%). The majority (82.3%) of pathogens were multidrug resistant. The death rate among device-associated healthcare infections was 69.2% with a crude excess mortality rate of 37.7%. The study sheds light on the proportion, types of device-associated healthcare infections, and underlying etiological agents associated with these infections in our institute's ICUs, thereby facilitating a better understanding of the healthcare-associated infection landscape within our facility. Moreover, the susceptibility patternof pathogens associated with these infections offers crucial information for guiding the selection of appropriate antimicrobial therapies and infection control measures.