Institutional Review Board Committee Research Articles

Association of SLCO1B1 gene variants with angiotensin-converting enzyme inhibitor-induced cough in a Pakistani hypertensive cohort.

Angiotensin-converting enzyme inhibitors (ACEIs) are prescribed for individuals with high cardiovascular (CV) risk; however, persistent cough limits the use of ACEIs in a large number of patients. The current study aimed to identify the genetic variants in the SLCO1B1 gene that might be associated with ACEI-related cough in a Pakistani hypertensive population. A prospective cohort study was conducted at a tertiary care hospital in Pakistan. A total of 74 patients who had been treated with ACEIs were recruited through a convenient sampling method. The study was approved by the Institutional Review Board & Ethics Committee of the Shifa International Hospital, Islamabad. Patients provided 2ml of blood for sequencing after signing informed consent. Partial gene sequencing of SLCO1B1 was carried out to find single nucleotide polymorphisms (SNPs) and haplotypes. It was found, through a structured questionnaire, that thirty-eight (38) patients experienced cough within 2weeks of ACEI administration and were considered as a case group (cough), and thirty-six (36) patients were considered as a control group (no cough). The incidence of cough was 51%. We found six different SNPs and 9 haplotypes in the partial gene sequences of SLCO1B1. Haplotype H4 was associated significantly with cough after adjusting for sex and smoking status. Other SNPs and haplotypes were not significantly associated with ACE-Is-induced cough. These findings emphasize the significance of SLCO1B1 genetic variants, specifically H4, as a potential predictor of ACEI-induced cough. It could be included in clinical practice as a possible risk factor for ACEI-induced cough once confirmed in larger clinical trials with bigger sample sizes. The replication of these findings in larger and more diverse populations is likely to contribute to the therapeutic use of ACEIs by predicting ACEI-induced cough.

Doctoral graduates’ attitudes toward scholarly work and Institutional Review Board and Quality Improvement Committee education and submission processes: A pilot study

BackgroundEducators are challenged to find better ways to prepare doctoral nursing students to conduct scholarly work involving human subjects. PurposeTo better understand doctoral nursing students’ attitudes toward programmatic scholarly work and Institutional Review Board (IRB)/Quality Improvement Committee (QIC) education and submission processes. MethodsRecent Doctor of Nursing Practice (DNP) and Philosophy of Nursing (PhD) graduates were recruited using convenience sampling techniques to participate in this cross-sectional, descriptive, mixed-methods pilot study. Data were collected using two researcher-developed instruments. DiscussionNineteen doctoral nursing students participated in this study. Students most often used a quantitative approach with health care providers to complete their scholarly work requirements. Both PhD and DNP participants were overall satisfied with the IRB/QIC content in the curricula and the submission process. Four themes were identified: (a) Efficiency, (b) Collaboration, (c) Faculty Mentorship, and (d) Areas for Improvement. ConclusionFindings from this pilot study may be used to enhance IRB/QIC processes through revision of administrative processes and student education.

Nursing Competence in Thrombolytic Therapy for Myocardial Infarction: A Public Teaching Hospital Study

Objectives: This study aims to evaluate the knowledge and proficiency of nurses in managing thrombolytic therapy for myocardial infarction. Methodology: A cross-sectional research design was adopted and conducted in a public teaching hospital from May 2020 to September 2020. Registered professional nurses (n=52) working in the emergency department (ED) and cardiac care unit (CCU) were invited to participate. A structured, pre-validated questionnaire was used for data collection. The study received approval from the institutional review board and ethics committee. Data were analyzed using SPSS version 25.0. Results: Fifty ED nurses participated in the study, predominantly male, aged ≤ 34 years, with ≤ 3 years of experience. The overall knowledge score of nurses regarding thrombolytic therapy was 71%, while the practice score was 79%. The lowest level of knowledge was related to contraindications (65%) and treatment protocols (66%), while the highest was for therapy considerations (85.2%). The lowest task performance (47.8%) was observed in the pre-administration phase. There was a negative correlation (r = -0.226) between knowledge and practice. Knowledge levels were higher among male nurses, while task performance was better among those with cardiac certification. Conclusion: The study revealed that while nurses had a favorable level of knowledge about thrombolytic therapy, their practical implementation was poor. This gap highlights the need for targeted educational programs and the establishment of efficient documentation systems to enhance clinical practice.

Surgical Management of Spinal Cysticercosis: 2-Dimensional Operative Video.

Neurocysticercosis is a notorious—albeit relatively rare—parasitic infection of the nervous system caused by ingestion of embryonated eggs or gravid proglottids of the pork tapeworm Taenia solium. 1 Most cases appear intracranially and can present with seizures and/or headache; far fewer affect the spinal canal alone. 1-6 We describe a case of a 66-year-old Hispanic man with isolated spinal cysticercosis presenting to the emergency department initially with axial back pain. After lumbar x-rays and a computed tomography scan failed to find any pathology, he was discharged home without neurosurgical consultation. A week later he would re-present to the same emergency department with worsening back pain and new neurologic deficits, prompting an MRI revealing pathology within the lumbar spinal canal. After consultation, the neurosurgical team discussed management strategies and eventually opted for surgical exploration of the patient's lumbar spine. This exploration eventually culminated in an intradural exploration, revealing an impressive string of interconnected larval cysts of the T. solium tapeworm within the cauda equina. The patient's neurologic condition improved immediately after surgery, and final pathologic examination supported a diagnosis of spinal cysticercosis, prompting the appropriate workup and medical treatment. He would ultimately make a full recovery and continues to follow-up with infectious disease at our institution. The patient consented to the surgical intervention described herein after a discussion of its risks, benefits, and alternatives. Institutional review board and ethics committee approval was not sought because the intervention did not constitute experimental surgery, but rather represented standard of care given the patient's condition on presentation.

Psychometric Properties of the Weight Loss Readiness Test in Active Duty Military Personnel Enrolled in a Weight Management Trial.

The Weight Loss Readiness Test (WLRT) was developed to encourage consideration of factors influencing readiness to engage in weight loss. The WLRT is used clinically, most notably to assess motivation before initiating Navy weight management programs, yet little is known about its psychometric properties. This study examined the reliability, convergent and predictive validity, and factor structure of the WLRT in a sample of active duty service members enrolling in a Navy-based weight management program (N = 178, identified as female = 61%, mean age = 29.7 years, mean baseline body mass index = 33.1 kg/m2). All procedures were approved by the respective Institutional Review Boards and research committees. Exploratory factor analysis revealed a 5-factor structure explaining 52% of the variance that best fit the data with low to moderate correlations between factors: (1) Motivation, (2) Exercise-Related Confidence, (3) Non-Exercise Confidence, (4) Cues, and (5) Anticipated Satisfaction. Internal reliability of subscales was acceptable to good (α = 0.755-0.903). Generally, convergent validity was found between the identified subscales and other measures of motivation, confidence, and disinhibited eating in expected directions. No relationships were found between the subscales and predictive validity outcomes (weight change, program attendance). Results indicate adequate structural and convergent validity in the WLRT, but that weight loss readiness, as measured by the WLRT, does not provide predictive validity regarding weight loss or attendance outcomes in this sample. Nonetheless, this measure offers clinical utility in fostering thoughtful conversations about weight loss. The WLRT uniquely focuses on long-term maintenance of behavior change and differentiates between exercise-related and non-exercise confidence. Future studies should further probe the utility of this measure in other populations and the contexts in which it is being used.

Abstract PO4-08-02: Genetic testing among patients with triple-negative breast cancer at a single health system: a quality improvement project

Abstract Background: Breast cancer is the most common type and the second leading cause of cancer-related deaths in women. Approximately 15-20% of patients have triple-negative breast cancer (TNBC) at diagnosis. TNBC is aggressive, difficult to treat, prone to relapse, and associated with an increased mortality rate. The incidence of BRCA1/2 mutation is about 20% in patients with TNBC (Hartman et al. 2012). Despite the high prevalence of germline mutations in cancer susceptibility genes among TNBC patients, many do not received genetic counseling (GC) or genetic testing (GT). National Comprehensive Cancer Network (NCCN) guidelines now recommend GT for all patients with TNBC, regardless of age, especially after the approval of Poly Adenosine diphosphate Ribose Polymerase (PARP) inhibitors for targeted therapy against BRCA1/2 mutations. The aim of this quality improvement (QI) project was to identify patients with TNBC who did not receive GT and design an intervention to understand potential barriers to receiving GC and GT. Methods: We implemented a QI project to identify previously diagnosed adult patients with TNBC (18 years and older) of any stage (early or advanced/metastatic) without prior GT or family history of genetic disorders with active follow-up at the Henry Ford health breast cancer clinic. Eligible patients diagnosed between January 2015 and January 2020 from the Syapse Learning Health Network database were included. Baseline information as well as additional data including demographics, breast cancer treatment details, and whether GT and/or GC was offered or not was obtained through electronic health record review after institutional review board committee approval. Bi-monthly meetings were held amongst breast cancer providers, genetic counselors, and nurse navigators to develop an intervention to contact the patients who did not undergo GT and/or GC. After obtaining the list of patients who did not undergo GT and/or GC despite meeting eligibility criteria, they were contacted by their primary breast cancer providers via telephone regarding their willingness to obtain GT and/or GC at this time and participate in a questionnaire-based interview to understand barriers towards the same. Results: In the 5 years, a total of 123 patients were noted to have been diagnosed with triple-negative breast cancer. Of these, 93 patients were actively being followed at the Henry Ford breast clinic at the time of the QI project. 2 of the 9 patients who underwent GT and GC were positive for BRCA1/2 mutation. Of the remaining 83 patients that did not receive GC or GT, 65 (78.3%) had no clear reason explained in the chart, 27 patients (32.5%) chose not to get tested, 23 (27.7%) were not deemed to be eligible upon initial assessment and 4 (4.8%) had pending orders placed by breast surgeons upon initial diagnosis. Unfortunately, 29 of these 83 patients were noted to have been deceased when the intervention was being designed. Remaining 54 patients were contacted by their primary breast cancer oncologists to determine their willingness in participating in the questionnaire-based interview. Conclusion: Based on the results of our QI project, we have now developed a process to contact the identified patients and renew the offer for GT and GC as well as participation in a questionnaire-based interview to understand the potential barriers to testing. We also plan to improve physician education and awareness by conducting mini sessions during our annual symposium meetings as well as grand rounds and develop a protocol for ordering GT and GC in patients with TNBC at our institution. Citation Format: Manasi Godbole, Mary Nyhuis, Travis Washburn, Joann Hirth, Haythem Ali. Genetic testing among patients with triple-negative breast cancer at a single health system: a quality improvement project [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-08-02.

Evaluating the effect of a mobile-based symptom monitoring system for improving physical function in patients with cancer during chemotherapy: study protocol for a multicentre randomised controlled trial

IntroductionSymptoms due to chemotherapy are common in patients with cancer. Cancer-related symptoms are closely associated with the deterioration of physical function which can be associated with decreased quality of life...

Comparatively tested potential risk factors across survivors and non-survivors critically patients

Background: The risk factors associated with mortality in critically ill patients have been the subject of numerous studies. However, a considerable amount of variation is evident when one considers the dispersion of patients, the geographical spread, and the classification of healthcare establishments. Aim: The purpose of this study was to compare potential risk factors between Survivors and Non-Survivors, including demographics, anthropometrics, kidney and liver indices, complete blood counts, and biochemical assays. Patients whose condition is critical. Methods: An ICU retrospective investigation was conducted in Jordan, where critically ill patients with surgical and medical conditions were examined. Using the Electronic Medical Record System (Hakeem), the study analysed data and classified patients into two cohorts according to their survival status. Demographic information, clinical characteristics, insulin administration rate, blood glucose levels, dosing schedules for vasopressors, and the burden of comorbidities were all included in the data. The research was granted approval by the Institutional Review Board committee of the Royal Medical Services, Jordan. Results: The research examined the male-to-female ratios among COVID-19 patients and classified them into six distinct age groups. A significant proportion of critical patients, ranging in age from 50 to 60, exhibited elevated corrected sodium levels and a diminished normontraemia status. Higher albumin levels and mean arterial pressures were associated with survivors, whereas a greater proportion of non-survivors were underweight and had a low BMI. A normal temperature was observed in the majority of critically ill patients, whereas non-survivors exhibited elevated fractional blood glucose levels and estimated creatinine clearances. The research emphasises the significance of treatment outcomes and patient demographics. Conclusion: SI may be a more accurate prognostic indicator than non-septic patients due to the effect of norepinephrine, a vasopressor, on heart rate and systolic blood pressure, which may account for the difference in SI values between the two groups.

Abstract 2585: First in human study with a novel peptide binder to glypican-3, demonstrates high specificity as a PET imaging agent in patients with hepatocellular carcinoma

Abstract Introduction: Hepatocellular carcinoma (HCC) is the most common primary liver malignancy. The American Association for the Study of Liver Disease recommends surveillance for high-risk individuals with abdominal ultrasound, triple phase contrast CT or MRI. However, these imaging techniques have limited sensitivity in classifying lesions smaller than 2 centimeters. The use of [18F]FDG Positron Emission Tomography (PET) is constrained due to insufficient uptake by HCC lesions over background liver uptake. Hence, there is an urgent need for more precise radiotracers for HCC. This study introduces the development of a novel radiotracer that binds to glypican-3 (GPC3), a cell membrane-anchored oncofetal protein overexpressed in HCC with minimal normal tissue expression. Methods: [68Ga]Ga-RYZ-GPC3 is composed of a small macrocyclic peptide binder with high affinity to GPC3 linked with a tetraxetan moiety capable of chelating a variety of radioisotopes including positron-emitting 68Ga and other radiometals. The unlabeled binder to GPC3 was synthesized by the sponsor and provided to three imaging centers in India as part of investigator-initiated trials reviewed and approved by each site’s institutional review board and ethics committee. Labeling with 68Ga and quality checks of the product was performed locally at each center. Patients with high clinical suspicion or with confirmed HCC who gave informed consent received injections of 1.5-5.5 mCi of [68Ga]Ga-RYZ-GPC3 and underwent PET-CT scanning at predetermined intervals. Some patients underwent companion [18F]FDG PET-CT scans in accordance with local guidelines. Results: A total of 64 patients underwent [68Ga]Ga-RYZ-GPC3 PET-CT scans. The median age within the cohort was 61 (41-83), 22% were female. Liver cirrhosis was present in 72% of patients, attributed to hepatitis B, hepatitis C or NASH in 17%, 13% and 20% of cases. Notably, 92% of patients exhibited at least one positive lesion on [68Ga]Ga-RYZ-GPC3 scans. The median SUVmax of GPC3-avid liver lesions was 15.5 (range 1.1 to 137.0) while the median liver SUVmean was 1.6 (0.3-7.9). Physiologic uptake was predominantly observed in the kidneys, the primary route of clearance, with a median SUVmean of 10.9 (2.2-20.7). Additionally, 20 patients underwent [18F]FDG PET-CT scan for comparison. The median SUVmax of lesions on 68Ga-RYZ-GPC3 vs [18F]FDG PET was 11.0 (1.1-137.0) vs 3.8 (1.2-12.2). Conclusion: Early human imaging results in patients with HCC indicate that [68Ga]Ga-RYZ-GPC3 has high tumor lesion specificity compared to normal liverand demonstrates the potential of [68Ga]Ga-RYZ-GPC3 to improve detection of HCC over conventional [18F]FDG PET-CT. In addition, the binder could be complexed with a therapeutic radioisotope as a novel targeted therapeutic option for HCC. Further investigation of this first-in-class binder to HCC is warranted. Citation Format: Chandresakhar Bal, Sanjana Ballal, Kumar Kallur, Anna Karmann, Ye Yuan, Jessica Rearden, Kathryn Shah, Charlotte Lorenz, Susan Moran, Ken Song, Ishita Sen. First in human study with a novel peptide binder to glypican-3, demonstrates high specificity as a PET imaging agent in patients with hepatocellular carcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2585.

(005) Can Novel SDS-089 Nasal Vardenafil Spray Solution Achieve Satisfactory Drug Plasma Level Similar to Oral Vardenafil Formulation? A Bioanalysis Study Comparing Vardenafil Nasal vs Oral Formulations Using Liquid Chromatography Tandem Mass Spectrometry

Abstract Introduction The nasal drug delivery system offers many advantages when compared with oral administration, such as a faster onset of action, easily accessible, less drug degradation, and a high rate of absorption. The SDS-089 nasal Vardenafil (VDF) solution is a unique drug formulation designed to be delivered as a spray formulation. Objective To assess the bioavailability of SDS-089 nasal Vardenafil solution in human plasma levels using Liquid Chromatography Tandem Mass Spectrometry analysis. Methods The SDS-089 Vardenafil HCl formulation was prepared with the active pharmaceutical ingredient to the United States Pharmacopeia (USP) standard (batch 1704002361). The SDS-089 nasal spray solution was filtered (0.22 μm filter) and fitted with a nasal spray device to deliver 100 μL per spray which is equivalent to 2 mg Vardenafil HCl alcoholic solution per spray. This study received approval from the Institutional Review Board and Biosafety Committee (FB18/IRB/099). Blood samples from participants were collected at time 0 (pre-dose) and across different time intervals up to 10 hours and analyzed using Liquid Chromatography Tandem Mass Spectrometry (LC/MS) to quantify the level of Vardenafil and the internal standard. This protocol allows for the preparation and analysis of human samples, quality controls (QC), standard curve preparation, and instrumental analysis. During the validation experiments, each calibration standard and QC sample was prepared by spiking a specified amount of Vardenafil in human plasma with oral Vardenafil drug served as the internal standard for comparison. The concentration of analytes in each standard was quantified using LC/MS and detected using multiple-reaction monitoring for each of the respective analytes. The lower limit of quantitation (LLOQ) was defined as the lowest concentration that could be quantified with accuracy and precision within 20%, as calculated from chromatograms for the independent samples. Intra- and inter-run accuracy and precision were calculated for the three QC samples, and independent triplicate measurements with best-fit lines were selected using a linear regression model with a 1/x2 weighting factor in the calibration curves. Results The SDS-089 nasal Vardenafil solution showed excellent accuracy (mean 100, Standard Deviation, SD 4.1, % Relative Standard Deviation, RSD of 4%) and good precision (mean 50.1, SD 2.1, %RSD of 4%) on high (50ng/ml) QC assay tests. Similarly, the stability of QC on high (50ng/ml) plasma assay tests showed excellent accuracy (mean 100.8, SD 3.7, %RSD of 4%) and good precision (mean 50.4, SD 1.8, %RSD of 4%) on high (50ng/ml). Comparison between pharmacokinetic parameters of Vardenafil SDS-089 nasal spray (4mg) and oral tablet (10mg) showed T1/2 (2.52±0.99 vs 2.46±0.73 hour), Tmax (0.17±0.54 vs 0.97±0.35 hour), Cmax (time concentrations) (9.21±4.11 vs 11.24±7.83 ng/mL) and AUC0-inf (area under the curve from zero to infinity) (21.03±12.54 vs 37.25±41.51 ng/mL*h) (see Table 1: Pharmacokinetic parameters of Vardenafil HCI as SDS-089 nasal spray vs. oral tablet using non-compartmental analysis WinNonlin software). Conclusions SDS-089 nasal formulation appeared to deliver a high plasma concentration level of Vardenafil drug based on pharmacokinetic LC/MS data analysis with robust accuracy and precision. Disclosure Yes, this is sponsored by industry/sponsor: LTR Pharma Clarification: Industry funding only - investigator initiated and executed study

(065) A Randomized, Single-Dose, Bioavailability and Safety Study on Novel SDS-089 Nasal Vardenafil 4mg Spray Solution in Comparison to Oral Vardenafil Tablet 10 mg in Healthy Volunteers

Abstract Introduction Oral phosphodiesterase type 5 inhibitor (PDE5i) is recognized as an effective first-line medical therapy for males with erectile dysfunction. However, oral PDE5i drug adherence and satisfaction rates were not high due to the need for oral ingestion, lack of sexual spontaneity, and delay in time to clinical effect. Hence, a nasal delivery of PDE5i drug may circumvent these limitations. Objective To assess the bioavailability and safety profile of SDS-089 nasal Vardenafil spray compared to oral Vardenafil 10mg tablet. Methods Following approval from Institutional Review Board and Biosafety Committee (FB18/IRB/099), 13 subjects out of the 32 healthy volunteers met the study criteria and were randomized to receive SDS-089 nasal Vardenafil spray (4 mg) or oral Vardenafil tablet (10 mg). The vardenafil HCl formulation SDS-089 was prepared with the active pharmaceutical ingredient meeting the United States Pharmacopeia (USP) standard (batch 1704002361). Blood tests were conducted on the subjects to evaluate Vardenafil drug bioavailability and treatment-related adverse events (TRAEs) data was collected. Results All 13 subjects completed the study. Based on the drug pharmacokinetics data, SDS-089 nasal spray was shown to have a faster onset and achieve optimal dose with a lower amount of drug compared to oral formulation. Of the 42 recorded TRAEs, 33 TRAEs were associated with the nasal spray, and 9 TRAEs were related to oral drugs. Transient headache is the most common TRAE in the nasal group and was very tolerable. The reported headaches showed no relationship with Cmax (peak concentration) and AUC0-inf (the total drug exposure across time) based on the Vardenafil drug levels. Conclusions SDS-089 nasal spray formulation Vardenafil HCl at 4 mg successfully achieved a similar Cmax with that of oral Vardenafil 10 mg tablet, and while it appeared to have more TRAEs, these were transient and well-tolerated by the subjects. Disclosure Yes, this is sponsored by industry/sponsor: LTR Pharma. Clarification: Industry funding only - investigator initiated and executed study.

Suicide and self-harm by burns in Pakistan: a scoping review protocol

IntroductionSuicide is a global public health problem. Self-inflicted burns are one of the most severe methods of suicide, with high morbidity and mortality. Low-income and middle-income countries contribute 40% of...

Effect of Weight Bearing on Medial Longitudinal Arch of Foot in Healthy Adults

Background: The medial longitudinal arch (MLA) of the foot plays a pivotal role in biomechanical stability and mobility. Understanding its behavior under different loading conditions is crucial for both clinical and sports-related applications. Previous studies have offered insights into the arch's adaptability, yet the impact of gender on this dynamic has remained underexplored. Objective: This study aimed to investigate the differences in medial longitudinal arch height between genders in non-weight bearing (NWB) and full weight bearing (FWB) positions, to ascertain if gender influences arch behavior under various loading conditions. Methods: Conducted at the Biomechanics and Kinesiology Laboratory of Shifa Tameer e Millat University, this cross-sectional study enrolled volunteers aged 18 to 40 years with normal foot arches. Exclusion criteria included history of foot pain, foot anomalies, pregnancy, or menstruation at the time of data collection. Navicular height was measured using Kinovea software (Version 0.9.5), with participants in both NWB and FWB positions. The study received approval from the Institutional Review Board and Ethics Committee of Shifa International Hospital (IRB # 0213-23). Statistical analysis was performed using independent and paired sample t-tests. Results: The study involved equal numbers of male and female participants, with no significant gender-based differences observed in navicular height in NWB (Males: Left Foot 5.17 ± 0.865, Right Foot 5.19 ± 0.675; Females: Left Foot 5.24 ± 0.89, Right Foot 5.39 ± 0.867) and FWB positions (Males: Left Foot 4.73 ± 0.834, Right Foot 4.88 ± 0.846; Females: Left Foot 4.83 ± 0.898, Right Foot 4.80 ± 0.837). Significant reductions in navicular height from NWB to FWB were noted across both genders (p < 0.01). Conclusion: The medial longitudinal arch height significantly changes under weight bearing, displaying a similar pattern of adaptability across genders. This indicates that gender does not significantly influence the biomechanical behavior of the MLA under the tested conditions.

Role of Psychological Stress and Choroidal Thickness in Central Serous Chorioretinopathy.

Central serous chorioretinopathy (CSCR) is a disease with a multifactorial aetiology. To evaluate the role of psychological stress and choroidal thickness in patients with CSCR. This was a hospital-based, analytical cross-sectional study, conducted at Christian Medical College, Vellore, India, from 2018 February to 2019 September, after the approval of the Institutional Review Board and Ethics Committee. Patients who satisfied the eligibility criteria of the study, were selected from the outpatient clinics of the Department of Ophthalmology. Twenty-five patients with unilateral CSCR (Group 1 - cases), and 50 age and gender-matched patients without CSCR (Group 2 - controls), randomly selected in a 1:2 ratio, were enrolled after obtaining informed consent. Psychological stress was assessed using Cohen Perceived Stress Scale (PSS-10). All patients had a Swept Source optical coherence tomography scan of the macula. Subfoveal choroidal thickness (SFCT) of both eyes of all participants was measured using a standard protocol. The data were collated and analysed, using Independent samples t-test and Chi-square/ Fisher's exact test, as appropriate, with IBM SPSS Statistics for Windows, version 21 (IBM Corp., Armonk, N.Y., USA). There was a significant difference between the two groups in mean stress scores (p <0.01), as well as stress categories (p <0.01). Although there was no significant difference in the prevalence of hypertension between the two groups (p = 0.33), there was a significant difference both in the mean systolic (p <0.01) and diastolic (p <0.01) blood pressure between the two groups. We found a significant difference between mean SFCT of CSCR eyes (421+/- 78.34 μm) and control eyes (314.24 +/- 52.48 μm, p <0.01), as well as between fellow eyes (396.20 +/- 68.79 μm) and control eyes (314.24 +/- 52.48 μm, p <0.01). However, there was no significant difference in the mean SFCT of CSCR eyes and fellow eyes (p =0.24). The findings reiterate the concept that the underlying pathophysiological changes leading to CSCR involve both the eyes of the patient. Psychological stress and hypertension may be factors that play an important role in the etiopathogenesis of the pachychoroid-related changes leading to CSCR. Stress relief measures, with a holistic approach to management, should be an integral part of the therapeutic strategies for CSCR.

Telemedicine in home-based care for COVID-19 patients

BackgroundThe COVID-19 pandemic has made devastating impacts on public health and global economy. While most people experience mild symptoms, it is highly transmissible and deadly in at-risk populations. Telemedicine has the potential to prevent hospitalization and provide remote care.MethodsThis retrospective study included 336 people with COVID-19, among which 141 (42%) and 195 (58%) were in Delta and Omicron dominant groups, respectively. Patients were confirmed to have COVID-19 by PCR or rapid test and were cared for via telemedicine. Severe cases were hospitalized for more intensive treatment. ResultsThe majority of individuals recovered at home (97.02%), while 2.98% required hospitalization. All hospital admissions were in Delta dominant group. No deaths were reported. Delta dominant group was more likely to develop loss of taste and smell, decreased appetite and need longer treatment time than those in Omicron dominant group.ConclusionsTelemedicine is a safe measure to provide at-home care for people with COVID-19 infections caused by both Delta and Omicron variants.Trial registrationThis study was approved by the Institutional Review Board Committee of University of Medicine and Pharmacy at Ho Chi Minh City (IRB No: 22115–DHYD).

Practices, perceptions and trust of the public regarding online drug purchasing: a web-based survey from Jordan

ObjectivesOnline purchasing, including drugs, increased dramatically in the last decade especially through the COVID-19 pandemic. The aim of this study was to investigate the frequency and attitudes of consumers concerning...

The Kaplan-Meier survival analysis of the dual sodium related comparative Jordanian critically ill cohorts whose major administered antibiotics were beta-lactams

Background: Abnormal serum sodium levels in various diseases increase mortality; however, hyperglycemia depresses serum sodium concentration significantly. Aim: This study aimed to evaluate the clinical impact of measured serum sodium levels and corrected sodium levels among Jordanian critically ill cohorts whose major administered antibiotics were Beta-Lactams Methods: This study was retrospectively conducted in the Intensive Care Unit (ICU) to primarily investigated the 2 proposed Na-based prognosticators against the overall mortality for the admitted critically ill patients in the Intensive Care Unit (ICU) at the King Hussein Medical Center between Jan 2018 and May 2021, after approval by the Royal Medical Services, Jordan local Institutional Review Board committee (IRB). A Kaplan-Meier test was conducted on the tested critically ill patients to explore the "time-to-event" during their admission days in the ICU and to determine if there were differences in the survival distribution for the different types of the 2 investigated dual different Na-related comparative cohorts [Measured Na related Events Cohort vs Measured Na related Censored Cohort and Corrected Na related Event Cohort vs Corrected Na related Censored Cohort]. Also, the Survival Kaplan-Meier test was used to plot the Survival functions’ illustrations for each tested Na-related mortality prognosticator. Results: The survival distributions for the 2 investigated dual comparative cohorts were statistically significantly different [χ2 (3) = 30.454, p-value=0.000 and χ2 (2) = 23.411, p-value=0.000, respectively] at Mean±SEM overall LOS of [21.444±0.138 days (95% CI; 21.173-21.714) and 21.444±0.138 days (95% CI; 21.173-21.714), respectively] and Number (%) of both Event and Censored cohorts of [1715 (79.6%) vs 440 (20.4%), respectively]. Conclusion: Our study revealed that both the measured and corrected hyponatremia had significant prognostic performances regarding major clinical outcomes when critically ill patients were studied regardless of their blood levels.

Lymphatic Malformations in Parkes Weber's Syndrome: Retrospective Review of 16 Cases in a Vascular Anomalies Center.

Parkes Weber's syndrome (PWS) is a rare genetic disorder characterized by overgrowth and vascular malformations, primarily affecting the extremities. While PWS is known to be associated with arteriovenous and capillary malformations, the potential involvement of lymphatic malformations (LMs) has not been previously reported. The objective of this study is to investigate the presence of lymphatic anomalies in PWS patients and their role in the development of limb asymmetry. This is a retrospective study of patients diagnosed with PWS in a Vascular Anomalies Center from 1994 to 2020. Clinical data were obtained from medical records including diagnostic imaging, lymphoscintigraphy, and genetic testing. The Institutional Review Board and Ethics Committee have approved this study. A total of 16 patients aged 18 interquartile range 14.7 years diagnosed with PWS were included (50% female). Six of the 16 patients with PWS had clinical and imaging data suggestive of LM (37.5%) and 3 of them had genetic variants in RASA1 (2/3) or KRAS (1/3). Limb asymmetry was greater in patients with isolated PWS (2.6 ± 0.8 cm) than in the PWS-lymphatic anomalies population (2 ± 0.7 cm), although not significant (p = 0.247). One in 6 patients with PWS-LM required amputation (16.6%) versus 1 in 10 in isolated PWS (10%). Lymphatic anomalies may be present in a significant number of patients with PWS and could have a role in limb asymmetry and outcomes. It is paramount to investigate their existence and distinguish them from true overgrowth.

Welcome to the New Issue (Vol: 29, No: 3, 2023) and Current News of the European Journal of Therapeutics

Welcome to the New Issue (Vol: 29, No: 3, 2023) and Current News of the European Journal of Therapeutics

Neuromodulation of spinal reflex pathway for the treatment of detrusor overactivity by medial plantar nerve stimulation at surface of sole of foot in patients with spinal cord injury.

Suprasacral spinal cord lesions are prone to have neurogenic detrusor overactivity leading to urinary incontinence. Current medical management has known side-effects and often surgical managements are irreversible. Electrical stimulation to modulate spinal reflex pathway having same nerve root as urinary bladder is reported in the literature. This study aimed to reduce detrusor overactivity in patients with spinal cord injury (SCI) using surface electrical stimulation of medial plantar nerve at the sole of foot. Twenty adults with SCI having episode of at least 1 leak/day due to detrusor overactivity as diagnosed by cystometrogram (CMG), were on clean intermittent catheterization and ankle jerk was present consented for the study. Participants were asked to maintain bladder diary a week before and during 2 weeks of treatment. CMG was done on day-0 and day-14. cmcUroModul@tor®, an inhouse developed electrical stimulator was used for ½ h daily for period of 2 weeks. Patient satisfaction feedback questionnaire was taken on completion of treatment. CMG data were analyzed using Wilcoxon signed-ranked test while bladder diary was analyzed using binomial distribution. P < 0.05 was considered as statistically significant. Institutional Review Board (IRB) and ethics committee of Christian Medical College, Vellore, approved the study (CMC/IRB/11061). Statistical significant improvement in maximum detrusor pressure (P = 0.03) and cystometric capacity (P = 0.04) was observed. Of 20 subjects, 18 showed improvement in bladder diary. Neuromodulation of medial plantar nerve at sole of foot by surface electrical stimulation is non-invasive, cost-effective, and alternative simple treatment modality for urinary incontinence due to detrusor overactivity.