Quantifying the Cost of Shigella Diarrhea in the Enterics for Global Health (EFGH) Shigella Surveillance Study.

Background: Comparative costs of public health interventions provide valuable data for decision making. However, the availability of comprehensive and context-specific costs is often limited. The Enterics for Global Health (EFGH) Shigella surveillance study-a facility-based diarrhea surveillance study across 7 countries-aims to generate evidence on health system and household costs associated with medically attended Shigella diarrhea in children. Methods: EFGH working groups comprising representatives from each country (Bangladesh, Kenya, Malawi, Mali, Pakistan, Peru, and The Gambia) developed the study methods. Over a 24-month surveillance period, facility-based surveys will collect data on resource use for the medical treatment of an estimated 9800 children aged 6-35 months with diarrhea. Through these surveys, we will describe and quantify medical resources used in the treatment of diarrhea (eg, medication, supplies, and provider salaries), nonmedical resources (eg, travel costs to the facility), and the amount of caregiver time lost from work to care for their sick child. To assign costs to each identified resource, we will use a combination of caregiver interviews, national medical price lists, and databases from the World Health Organization and the International Labor Organization. Our primary outcome will be the estimated cost per inpatient and outpatient episode of medically attended Shigella diarrhea treatment across countries, levels of care, and illness severity. We will conduct sensitivity and scenario analysis to determine how unit costs vary across scenarios. Conclusions: Results from this study will contribute to the existing body of literature on diarrhea costing and inform future policy decisions related to investments in preventive strategies for Shigella.

Data Management in Multicountry Consortium Studies: The Enterics For Global Health (EFGH) Shigella Surveillance Study Example.

Background: Rigorous data management systems and planning are essential to successful research projects, especially for large, multicountry consortium studies involving partnerships across multiple institutions. Here we describe the development and implementation of data management systems and procedures for the Enterics For Global Health (EFGH) Shigella surveillance study-a 7-country diarrhea surveillance study that will conduct facility-based surveillance concurrent with population-based enumeration and a health care utilization survey to estimate the incidence of Shigella--associated diarrhea in children 6 to 35 months old. Methods: The goals of EFGH data management are to utilize the knowledge and experience of consortium members to collect high-quality data and ensure equity in access and decision-making. During the planning phase before study initiation, a working group of representatives from each EFGH country site, the coordination team, and other partners met regularly to develop the data management systems for the study. Results: This resulted in the Data Management Plan, which included selecting REDCap and SurveyCTO as the primary database systems. Consequently, we laid out procedures for data processing and storage, study monitoring and reporting, data quality control and assurance activities, and data access. The data management system and associated real-time visualizations allow for rapid data cleaning activities and progress monitoring and will enable quicker time to analysis. Conclusions: Experiences from this study will contribute toward enriching the sparse landscape of data management methods publications and serve as a case study for future studies seeking to collect and manage data consistently and rigorously while maintaining equitable access to and control of data.

Hydrogel Containing Solid Lipid Nanoparticles Loaded with Argan Oil and Simvastatin: Preparation, In Vitro and Ex Vivo Assessment.

Transdermal hydrogels have the potential to improve therapeutic outcomes via enhancing bioavailability and reducing toxicity associated with oral delivery. The goal of the present study was to formulate and optimise argan oil loaded transdermal hydrogel containing lipid nanoparticles. The high pressure homogenization (HPH) method was utilised to fabricate Simvastatin loaded solid lipid nanoparticles (SIM-SLNs) with precirol ATO 5 as a lipid core and Poloxamer 407 (P407) to stabilise the core. The optimised nanoformulation was characterised for its particle diameter, zeta potential, surface morphology, entrapment efficiency, crystallinity and molecular interaction. Furthermore, transdermal hydrogel was characterised for physical appearance, rheology, pH, bio adhesion, extrudability, spreadability and safety profile. In vitro and ex vivo assays were executed to gauge the potential of SLNs and argan oil for transdermal delivery. The mean particle size, zeta potential and polydispersity index (PDI) of the optimised nanoparticles were 205 nm, -16.6 mV and 0.127, respectively. Crystallinity studies and Fourier transform infrared (FTIR) analysis revealed no molecular interaction. The in vitro release model explains anomalous non-Fickian release of drug from matrix system. Ex vivo skin penetration studies conducted through a fluorescence microscope confirmed penetration of the formulation across the stratum corneum. Hydrogel plays a crucial role in controlling the burst release and imparting the effect of argan oil as hypolipidemic agent and permeation enhancer.

A Performance Assessment Study of Different Clinical Samples for Rapid COVID-19 Antigen Diagnosis Tests.

Accurate diagnosis to limit the spread of SARS-CoV-2 is crucial for the clinical management of this lethal infection. Recently, many low-cost and easy-to-use rapid test kits (RTK) have been developed in many countries for the massive screening of SARS-CoV-2. Thus, evaluating the accuracy and reliability of an RTK is critical. The current study was conducted on 157 individuals to evaluate the performance accuracy of rapid SARS-CoV-2 antigen detection kits using different clinical samples compared with qRT-PCR results. Nasopharyngeal swabs were collected from patients for qRT-PCR and RTK tests, and then buccal and nasal, and nasal swabs were collected for RTK tests separately. The nasal and buccal swabs showed high sensitivity (98%) and specificity (100%) compared with the qRT-PCR results. Meanwhile, for nasal, the sensitivity was 96% with 98% specificity, and nasopharyngeal swabs showed 98% sensitivity and 94% specificity. Fisher's exact test revealed statistical significance (p < 0.05) between nasopharyngeal, nasal and buccal, and nasal swabs compared with qRT-PCR results. The study concludes that different clinical samples used for the rapid diagnosis of SARS-CoV-2 showed high sensitivities and specificities compared with qRT-PCR. The RTKs using nasal and buccal, nasopharyngeal, and nasal swabs are valuable tools for the early detection of SARS-CoV-2, especially when molecular detections are available with limited access and a high infectivity rate, when the timely detection of virus cases is urgently needed. These types of clinical samples are effective to be used by RTKs for surveillance among community and healthcare workers.

Equity impact of participatory learning and action community mobilisation and mHealth interventions to prevent and control type 2 diabetes and intermediate hyperglycaemia in rural Bangladesh: analysis of a cluster randomised controlled trial.

BACKGROUND: A cluster randomised trial of mHealth and participatory learning and action (PLA) community mobilisation interventions showed that PLA significantly reduced the prevalence of intermediate hyperglycaemia and type 2 diabetes mellitus (T2DM) and the incidence of T2DM among adults in rural Bangladesh; mHealth improved knowledge but showed no effect on glycaemic outcomes. We explore the equity of intervention reach and impact. METHODS: Intervention reach and primary outcomes of intermediate hyperglycaemia and T2DM were assessed through interview surveys and blood fasting glucose and 2-hour oral glucose tolerance tests among population-based samples of adults aged ≥30 years. Age-stratified, gender-stratified and wealth-stratified intervention effects were estimated using random effects logistic regression. RESULTS: PLA participants were similar to non-participants, though female participants were younger and more likely to be married than female non-participants. Differences including age, education, wealth and marital status were observed between individuals exposed and those not exposed to the mHealth intervention.PLA reduced the prevalence of T2DM and intermediate hyperglycaemia in all age, gender and wealth strata. Reductions in 2-year incidence of T2DM of at least 51% (0.49, 95% CI 0.26 to 0.92) were observed in all strata except among the oldest and least poor groups. mHealth impact on glycaemic outcomes was observed only among the youngest group, where a 47% reduction in the 2-year incidence of T2DM was observed (0.53, 95% CI 0.28 to 1.00). CONCLUSION: Large impacts of PLA across all strata indicate a highly effective and equitable intervention. mHealth may be more suitable for targeting higher risk, younger populations. TRIAL REGISTRATION NUMBER: ISRCTN41083256.

Assessment of trends in climatic extremes from observational data in the Kashmir basin, NW Himalaya.

The present study aims to assess the recent changes and trends in the extreme climate indices in the Kashmir basin using the observational records from 1980 to 2016. The extreme climate indices were computed using the ClimPACT2 software and a total of 39 indices were selected for the analysis having particular utility to various sectors like agriculture, water resources, energy consumption, and human health. Besides adopting the station scale analysis, regional averages were computed for each index. In terms of the mean climatology, an increase has been observed in the annual mean temperature with a magnitude of 0.024 °C/year. Further, differential warming patterns have been observed in the mean maximum and minimum temperatures with mean maximum temperature revealing higher increases than mean minimum temperature. On the other hand, the annual precipitation shows a decrease over most of the region, and the decreases are more pronouncing in the higher altitudes. The trend analysis of the extreme indices reveals that in consonance with the rising temperature there has been an increase in the warm temperatures and decrease in the cold temperatures across the Kashmir basin. Furthermore, our analysis suggests a decrease in the extreme precipitation events. The drought indices viz., Standardised Precipitation Index (SPI), and Standardised Precipitation Evapotranspiration Index (SPEI) manifest decreasing trends with the tendency towards drier regimes implying the need for better water resource management in the region under changing climate.

Assessment of Vitamin D Levels in Patients Presenting With Chronic Low Back Pain at a Tertiary Care Hospital.

Objective To evaluate the association of chronic low back pain with levels of vitamin D in the affected population. Methodology This observational study was carried out from August 2016 to August 2019 at Khairpur Medical College and Shaheed Mohatarma Benazir Bhutto Medical College, Karachi, Pakistan. Patients aged 18 years and above suffering from chronic low back pain with pain persisting for more than 12 weeks were the study participants after written consent and prior approval from the ethical review committee was obtained for conducting the study. Data was recorded on predesigned performa and analyzed on SPSS Version 20 (IBM Corp.). Results There were 1,152 cases with chronic lower back pain, of whom 632 (54.9%) were females and 520 (45.1%) were males. The mean age of the patients was 41.76 ± 11.18 years. The mean visual analog scale (VAS) level was 5.36 ± 1.65; 707 cases (61.4%) had moderate pain according to VAS, 292 (25.3%) had severe pain, and 153 (13.3%) had mild pain. Concerning vitamin D levels, the mean levels were 22.74 ± 13.80, with 599 (52%) of the patients having deficient levels of vitamin D, 347 (30.1%) having insufficient levels, and only 204 (17.7%) of the cases having normal vitamin D levels. Conclusions Lower back pain is one of the common presenting problems in orthopedic clinics. We found no relationship between chronic lower back pain and vitamin D levels in our study.

Preclinical evaluation of a thin-strut bioresorbable scaffold (ArterioSorb): acute-phase invasive imaging assessment and hemodynamic implication.

AIMS: The aim of this study was to assess the acute performance of the 95 µm ArterioSorb oriented poly L-lactic acid (PLLA) scaffold in comparison with the XIENCE metallic drug-eluting stent (DES) in porcine coronary arteries. METHODS AND RESULTS: In 15 non-atherosclerotic Yucatan mini pigs, the ArterioSorb (3.0/14 mm) and XIENCE (3.0/15 mm) were implanted in 25 and 15 vessels, respectively. Acute performance was evaluated by using quantitative coronary angiography (QCA) and optical coherence tomography (OCT). Following three-dimensional reconstruction of the coronary arteries, endothelial shear stress (ESS) was quantified using non-Newtonian steady-flow simulation. Acute recoil measured by QCA was comparable in the two arms. Post-procedural flow and scaffold/stent area by OCT did not differ between the two devices. ESS post procedure was comparable between ArterioSorb and XIENCE (2.21±1.97 vs 2.25±1.71 Pa, p=0.314). CONCLUSIONS: Acute recoil, luminal dimensions and ESS in the ArterioSorb oriented PLLA scaffold with thin struts of 95 µm were comparable to those in the XIENCE metallic DES.

Assessment of benzene, toluene, ethyl-benzene, and xylene (BTEX) toxicity in soil using sulfur-oxidizing bacterial (SOB) bioassay.

The assessment of benzene, toluene, ethyl-benzene, and xylene (BTEX)-contaminated soil toxicity was performed using a sulfur-oxidizing bacteria (SOB) assay. The experiments were set up using an individual pollutant in a 25-mL bottle sealed with a rubber stopper and aluminum cap since BTEX are volatile. A large headspace volume (14 mL) was kept in the reactors to provide enough oxygen for the SOB. Soil samples were spiked with BTEX compounds in the concentration range of 1-1000 mg/kg. In reactors without BTEX compounds, approximately 85% of the theoretically required oxygen was consumed. Whereas, the reactors with benzene consumed in the range of 82-64% (5-100 mg/kg), those with toluene consumed 76-53% (1-50 mg/kg), those with ethyl-benzene consumed 44-71% (5-100 mg/kg), and those with xylene consumed 64-71% (1-10 mg/kg) of the theoretically required oxygen. The effective concentrations responsible for 50% growth inhibition (EC50) for benzene, toluene, ethyl-benzene, and xylene detection were 130.2, 1.2, 15.2, and 0.7 mg/kg, respectively. These results suggest that this SOB-based bioassay can detect BTEX pollutants in soils.

Protocol of economic evaluation and equity impact analysis of mHealth and community groups for prevention and control of diabetes in rural Bangladesh in a three-arm cluster randomised controlled trial.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is one of the leading causes of death and disability worldwide, generating substantial economic burden for people with diabetes and their families, and to health systems and national economies. Bangladesh has one of the largest numbers of adults with diabetes in the South Asian region. This paper describes the planned economic evaluation of a three-arm cluster randomised control trial of mHealth and community mobilisation interventions to prevent and control T2DM and non-communicable diseases' risk factors in rural Bangladesh (D-Magic trial). METHODS AND ANALYSIS: The economic evaluation will be conducted as a within-trial analysis to evaluate the incremental costs and health outcomes of mHealth and community mobilisation interventions compared with the status quo. The analyses will be conducted from a societal perspective, assessing the economic impact for all parties affected by the interventions, including implementing agencies (programme costs), healthcare providers, and participants and their households. Incremental cost-effectiveness ratios (ICERs) will be calculated in terms of cost per case of intermediate hyperglycaemia and T2DM prevented and cost per case of diabetes prevented among individuals with intermediate hyperglycaemia at baseline and cost per mm Hg reduction in systolic blood pressure. In addition to ICERs, the economic evaluation will be presented as a cost-consequence analysis where the incremental costs and all statistically significant outcomes will be listed separately. Robustness of the results will be assessed through sensitivity analyses. In addition, an analysis of equity impact of the interventions will be conducted. ETHICS AND DISSEMINATION: The approval to conduct the study was obtained by the University College London Research Ethics Committee (4766/002) and by the Ethical Review Committee of the Diabetic Association of Bangladesh (BADAS-ERC/EC/t5100246). The findings of this study will be disseminated through different means within academia and the wider policy sphere. TRIAL REGISTRATION NUMBER: ISRCTN41083256; Pre-results.

Research Assistants Caught in Limbo: Considering Their Role in Quantitative, Longitudinal Research with Vulnerable Populations.

Research assistants (RAs) play a variety of roles that are critical in making research happen and in determining its quality and effectiveness. Yet their locus of power in the production of knowledge stands in sharp contrast to their relative powerlessness in the hierarchical research organization. This article explores the experiences of RAs engaged in a randomized controlled longitudinal field trial of a Housing First intervention for individuals experiencing homelessness and mental illness in Toronto. They encountered several unexpected effects of navigating the power ascribed to them by both study participants and community service providers. This study underscores the importance of acknowledging that RAs are the face of the research study in the field, and of better understanding implications associated with that fact, especially when marginalized populations and their providers are involved.

Assessment with Oswestry disability index in surgically treated patients with lumbar spondylolisthesis: experience in 96 patients.

OBJECTIVE: To assess the outcome of surgical treatment in spondylolisthesis of lumbosacral region using Oswestry disability Index. METHODS: The quasi-experimental study was conducted at the Combined Military Hospital, Rawalpindi from 2006 to 2013 and comprised surgically treated patients with spondylolisthesis. The patients with degenerative and isthmic types with follow-up of at least two years were included. A performa was designed for each patient and records were kept in a custom-built database. Oswestry disability index was used as the assessment tool and assessment was done pre-operatively, at 1, 3 and 6 months and then at 1 year and 2 years. RESULTS: There were 96 patients with mean pre-op Oswestry disability index score of 81.06% (range 42.22-100, SD ±11.99). L5-S1 was affected in 44 (45.83%) patients, L4-L5 in 30 (31.25%), L4-5-S1 in 7 (7.29%) and multi or high level was found in the rest of the cases. One level was involved in 77 (80.2%), 2 in 11 (11.45%), 3 in 7 (7.29%) and 4 in 1 (1.04%). The slip grade as per Meyerding grades was 1 in 31 (32.29%), II in 39 (40.62%), III in 19 (19.79%), IV in 5 (5.2%) and 2 (2.08%) had spondyloptosis. Mean follow-up was 42 months (range 24-63). Mean Oswestry disability score at 1 month was 38.51% (range 11- 62.22%, SD ±11.75); at 6 months 10.02% (range 0-40%, SD ±6.99); at 1 year 4.62% (range 0-24%, SD ±5.36) and at 2 years 4.21% (range 0-15%, SD ±4.2). CONCLUSIONS: Surgical treatment of spondylolisthesis gives excellent long-term result in most patients.

Screening laboratory and radiology panels for trauma patients have low utility and are not cost effective.

BACKGROUND: Routine laboratory and radiology panels as part of the initial evaluation of the trauma patient are prevalent practices. This is a study of utility and cost effectiveness of this practice. METHODS: During a 3-month period, trauma panels were analyzed for cost and impact on patient care in our institution. RESULTS: Four hundred ten consecutive patients had 3,982 studies (cost $417,839) performed of which 1,292 (cost $114,753) were abnormal and only 253 (cost $36,703) were clinically contributory. CONCLUSIONS: Routine panels are not useful or cost effective. Negative results contribute little to management. Selective and targeted studies should be indicated by the secondary survey, and may result in substantial cost savings ($1,500,000 per year at our institution).

Residents managed trauma adequately using their own radiological interpretation as compared with "nighthawk" radiologists.

OBJECTIVE: To determine whether senior surgical residents can independently interpret radiologic studies for the trauma patients under their care. METHOD: Five senior surgical residents (PGY-4 and -5) participated in this prospective study. The residents independently read trauma films as part of the emergency assessment, documenting their interpretations to be compared with the reports by nighthawk radiologists. RESULTS: During a period of 4 months, 426 films of 124 trauma patients admitted to a Level II trauma center were read by one of the five senior surgical residents, and by nighthawk radiologists. Approximately 22% of these were penetrating injuries and the remainder blunt trauma. Residents identified 127 injuries versus 128 injuries identified by the radiologists, with 99.2% agreement. The residents missed two injuries, while the radiologists missed one. CONCLUSIONS: Senior surgical residents can independently and accurately interpret the trauma radiology studies, a skill essential for time-critical decision making.

The contribution of laparoscopy in evaluation of penetrating abdominal wounds.

BACKGROUND: Penetrating abdominal wounds are traditionally explored by laparotomy. We investigated prospectively the role of laparoscopy within a defined protocol for management of penetrating abdominal wounds to determine its safety and advantages over traditional operative management. STUDY DESIGN: The study inclusion criteria were: stab and gun shot abdominal wounds, including junction zone injuries; stable vital signs; and absence of contraindications for laparoscopy. Diagnostic end points included detection of peritoneum or diaphragm violation, visceral injuries, and other indications for laparotomy. Systematic examination was undertaken using a multiport technique whenever the peritoneum or diaphragm had been violated. All repairs were done by open operation. RESULTS: A total of 40.6% of patients with penetrating trauma fulfilled study criteria (52 patients). Of these, 33% had no peritoneal penetration; 29% had no visceral injuries despite violation of peritoneum or diaphragm; 38% had visceral injuries, of which 40% (mainly liver and omentum) required no intervention. Twelve patients (23% of total) had open repairs. No missed injuries or death occurred in the study. Overall, 77% of penetrating injuries with stable vital signs avoided exploratory laparotomy. Compared with National Trauma Data Bank information for patients with the same Injury Severity Scores, hospitalization was reduced by more than 55% for the entire series. CONCLUSIONS: Laparoscopy for penetrating abdominal injuries in a defined set of conditions was safe and accurate, effectively eliminating nontherapeutic laparotomy and shortening hospitalization.