Quality Assurance Sampling Research Articles

Identifying the zero-dose and under-immunized children in Bangladesh: Approaches and experiences.

This paper presents and elaborates on empirical methods and approaches used to identify Zero-Dose (ZD) and Under-immunized (UI) children as well as the communities that these children reside in within Bangladesh. This paper also describes demand- and supply side-barriers that lead to children being ZD and UI in the country. Time period for the study was December 2022-May 2023. The study methodology encompassed secondary data analysis using data from national surveys, primary data collection and analysis via a lot quality assurance sampling (LQAS) survey and also, qualitative data collection and analysis. Study population included caregivers of children aged 4.5 months (4 months 15 days) to 23 months for the LQAS survey. The qualitative component included policymakers, program managers and service providers working in immunization as well as mothers in the selected study areas who had a living child aged less than 2 years as the study population. Our data analysis confirms existence of ZD and UI children in areas which were categorized into haor (wetlands), hilly, char (sandy/silty land surrounded by water), coastal, plain land and urban slums. Determinant analysis showed that the mother's level of education, antenatal visits made, and access to media were significantly associated with children being ZD or UI. Reproductive autonomy emerged as a key factor that had prominent impact on a child being ZD. The qualitative analysis indicated the importance of population migration, health workforce shortages and lack of access to transportation as prominent barriers to immunization. Notably, the methods and approaches used in this study are both effective and easily replicable to identify ZD and UI children. The drivers of ZD and UI along with the barriers to immunization provide potential areas for intervention by policy-makers and can apprise about interventions to be tested in future implementation research.

A-043 A Fast, Novel and Analytically Sensitive Clinical Research Method for the Analysis of Free Testosterone using UPLC-MS/MS

Abstract Background The aim of this work was to develop an analytically sensitive, rapid clinical research method for the analysis of free testosterone in serum using a small sample volume. Laboratories have found this difficult, partly due to the inherent low concentrations (less than 3% of total testosterone is free), technical challenges and variability in results have been noted with equilibrium dialysis, which is considered the gold standard. Methods Testosterone certified reference material (Merck, UK) was used to create calibrators in 52.75 mM HEPES buffer adjusted to pH 7.4 to mimic the ionic environment of serum. Precision was evaluated using in-house QC materials prepared in serum (Golden West Biologicals, USA and BioIVT, UK). 200 µL serum was incubated at 37°C with 400 µL pH-adjusted 52.75 mM HEPES buffer for 2 hours, mixing at 800 r.p.m. with Rapid Equilibrium Analysis (RED) inserts and plates (Thermo Scientific™, UK). Testosterone-13C3 (Merck, UK) was spiked into resultant diasylate, then liquid-liquid extraction (LLE) was used to concentrate and clean the sample. The ACQUITY™ UPLC™ I-Class System with the Waters™ ACQUITY UPLC BEH C18, 1.7µm, 2.1 x 100 mm Column using a water/methanol/ammonium fluoride gradient and the Waters Xevo™ TQ Absolute Mass Spectrometer were used for quantification. An accelerated protocol for equilibrium dialysis, using a 2-hour incubation and fast mixing step was used (4 hours or longer is more typical historically) though it is essential to control the pH of the dialysis buffer and, particularly, the temperature of the chamber. Results No significant carryover or matrix effects were demonstrated with linearity from 0.5-650 pg/mL. Addition of high concentrations of endogenous substances (albumin, bilirubin, creatinine, cholesterol, triglycerides and uric acid) did not affect quantification. Analytical sensitivity investigations indicated the analytical sensitivity would allow precise quantification (≤20%CV and ≤15% bias) at 0.50 pg/mL. Coefficients of variation (CV) for total precision and repeatability on 5 analytical runs for low, mid and high QCs at approximately 2.79, 8.80 and 134 pg/mL respectively were all ≤ 8.4% (n=25). Accuracy was assessed by analyzing 45 male external quality assurance samples (NEQAS, UK) ranging in concentration from 50.1-268.6 pg/mL and the Bland-Altman agreement showed a small negative bias of -7.6% compared with the all-laboratory trimmed mean (ALTM), though excellent agreement overall. When LC-MS/MS determined concentrations were processed against Vermeulen equation determined concentrations (total testosterone and SHBG concentrations were provided by the scheme, a concentration of 45 g/L albumin was assumed), again good agreement was shown by the Bland-Altman bias of -7.7%. Conclusions A novel clinical research method using a fast equilibrium dialysis procedure with LLE and LC-MS/MS analysis with only 200 µL of serum has been demonstrated for clinical research use. Sub pg/mL analytical sensitivity, excellent linearity and precision, with minimal matrix effects and a strong agreement with an EQA scheme were established.

B-115 Software Data Processing and Review LC-MS/MS Workflow Improvements for Clinical Research

Abstract Background In the field of quantitative LC-MS/MS, the need for efficient, accurate and user-friendly data review software is paramount, with the data generated in the clinical laboratory meeting local guidelines, as well as rigorous method performance characteristics defined by the FDA Bioanalytical Method Validation and CLSI C62-Ed2 guidelines. The quantitative LC-MS/MS workflow is dependent on interfacing to LMS/LIMS for sample traceability, batch analysis using matrix-matched external calibrators and quality controls for quantification and acceptance, and stable-isotope labeled internal standards to compensate for sample extraction, recovery, matrix effects and analytical variability. The demands on the laboratory to run multiplexed analyte panels and analyze a greater number of samples produces large amounts of analytical data which must still go through batch and quality review before release from the laboratory to the clinicians. The Waters Quan Review Software significantly reduces the burdensome aspects of batch quality control by introducing a series of innovative features. These include improvements in workflow, a modernized interface, and the ability to flag exceptions based on acceptance criteria. Methods Samples for three multiplexed LC-MS/MS panels with previously defined analytical method performance characteristics were acquired using Waters IVD Systems controlled by MassLynx software. The data was processed, quantified, and reviewed using both the existing TargetLynx XS IVD Application Manager and the new Quan Review Software. The three quantitative LC-MS/MS methods were the analysis of four immunosuppressants drugs in whole blood, a twelve steroid panel in plasma and a urine dilute and shoot method for a drugs of abuse panel containing greater than 80 analytes. Each method used matrix matched calibrators and QCs for quantification and batch control with performance characteristics including calibration linearity, carryover, precision and accuracy. Results The analytical performance data generated using the new MS Quan data review software met the same performance criteria as the TargetLynx XS data. For immunosuppressants, the % difference of the mean repeatability and total precision (%CV) for the individual analyte QCs processed using both software was within ±1.3% and ±4.4% respectively. The mean % bias of External Quality Assurance Samples (n=40) for each immunosuppressant processed using both software was within ±7.9%. The modernized, task-oriented accelerated workflows and focused review by exception reduced review time by up to 50%. Conclusions The new Quan Review Software generated results equivalent to the existing TargetLynx XS Application Manager. The software’s enhanced workflow capabilities streamlined the review process in a new user-friendly interface which reduced the training burden enabling scientists to generate high-quality data quickly and easily. The exception focused review functionality allowed tailored rule sets which reduced the time spent reviewing data by up to 50%. Whilst the batch-level review and task-oriented workflow improved batch acceptance and simplified the review of complicated datasets into easy tasks. By integrating these features, Data Review software offers a comprehensive solution that not only improves the efficiency and accuracy of batch quality control but also contributes to the overall reliability and integrity of quantitative LC-MS/MS analysis. For Research Use Only. Not for Use in Diagnostic Procedures.

Adaptation of lot quality assurance sampling to monitor seasonal malaria chemoprevention delivery performance.

Malaria Consortium supports delivery of seasonal malaria chemoprevention (SMC) to children ages 3-59months using sulfadoxine-pyrimethamine plus amodiaquine. Lot quality assurance sampling (LQAS) was adapted as a cost-efficient method for end-of-cycle SMC monitoring surveys across supported countries and an implementation challenges reporting system was established in Nigeria. We present a case study of its application in Nasarawa State. LQAS facilitated timely local performance assessment across 16 indicators. Development of new reporting tools has played a key role in stimulating national-level discussions on improvements to SMC supervisory processes and implementer training and provided a framework for engagement with local stakeholders.

Lot quality assurance sampling survey for water, sanitation and hygiene monitoring and evidence-based advocacy in Bentiu IDP camp, South Sudan.

Every year, 60% of deaths from diarrhoeal disease occur in low and middle-income countries due to inadequate water, sanitation, and hygiene. In these countries, diarrhoeal diseases are the second leading cause of death in children under five, excluding neonatal deaths. The approximately 100,000 people residing in the Bentiu Internally Displaced Population (IDP) camp in South Sudan have previously experienced water, sanitation, and hygiene outbreaks, including an ongoing Hepatitis E outbreak in 2021. This study aimed to assess the gaps in Water, Sanitation, and Hygiene (WASH), prioritise areas for intervention, and advocate for the improvement of WASH services based on the findings. A cross-sectional lot quality assurance sampling (LQAS) survey was conducted in ninety-five households to collect data on water, sanitation, and hygiene (WASH) coverage performance across five sectors. Nineteen households were allocated to each sector, referred to as supervision areas in LQAS surveys. Probability proportional to size sampling was used to determine the number of households to sample in each sector block selected using a geographic positioning system. One adult respondent, familiar with the household, was chosen to answer WASH-related questions, and one child under the age of five was selected through a lottery method to assess the prevalence of WASH-related disease morbidities in the previous two weeks. The data were collected using the KoBoCollect mobile application. Data analysis was conducted using R statistical software and a generic LQAS Excel analyser. Crude values, weighted averages, and 95% confidence intervals were calculated for each indicator. Target coverage benchmarks set by program managers and WASH guidelines were used to classify the performance of each indicator. The LQAS survey revealed that five out of 13 clean water supply indicators, eight out of 10 hygiene and sanitation indicators, and two out of four health indicators did not meet the target coverage. Regarding the clean water supply indicators, 68.9% (95% CI 60.8%-77.1%) of households reported having water available six days a week, while 37% (95% CI 27%-46%) had water containers in adequate condition. For the hygiene and sanitation indicators, 17.9% (95% CI 10.9%-24.8%) of households had handwashing points in their living area, 66.8% (95% CI 49%-84.6%) had their own jug for cleansing after defaecation, and 26.4% (95% CI 17.4%-35.3%) of households had one piece of soap. More than 40% of households wash dead bodies at funerals and wash their hands in a shared bowl. Households with sanitary facilities at an acceptable level were 22.8% (95% CI 15.6%-30.1%), while 13.2% (95% CI 6.6%-19.9%) of households had functioning handwashing points at the latrines. Over the previous two weeks, 57.9% (95% CI 49.6-69.7%) of households reported no diarrhoea, and 71.3% (95% CI 62.1%-80.6%) reported no eye infections among children under five. The camp's hygiene and sanitation situation necessitated immediate intervention to halt the hepatitis E outbreak and prevent further WASH-related outbreaks and health issues. The LQAS findings were employed to advocate for interventions addressing the WASH gaps, resulting in WASH and health actors stepping in.

Prevalence, patterns, and determinants of breastfeeding cessation among mothers of children under 24 months in Uganda

BackgroundBreastfeeding duration is a critical component of infant and child nutrition, providing immediate and long-term benefits to both children and their mothers. This study uses data from the lot quality assurance sampling (LQAS) survey to examine the prevalence, patterns, and determinants of breastfeeding cessation in Uganda.MethodsThis study was a secondary analysis of data collected by the cross-sectional LQAS surveys in 2021 and 2022 covering 77 districts in Uganda. The LQAS survey methodology employs a systematic sampling approach to assess whether predefined quality standards are met within specific subgroups of a population. The study employed spatial analysis, bivariate analysis and logistic regression, both with and without clustering, to explore associations between independent variables and breastfeeding cessation. Unadjusted and adjusted odds ratios with 95% confidence intervals were calculated. Statistical significance was set at 5%.ResultsOverall, the study analysed 26,377 records of mothers with children under 24 months old. The mothers’ mean age was 27.9 years while that of their children was 11.0 months. While the general breastfeeding cessation rate was 17.7%, cessation was highest (49.7%) among mothers of children 18-23 months. Factors associated with increased odds of breastfeeding cessation included older child’s age, older mother’s age, using modern family planning, being pregnant and having an unknown pregnancy status. Lower odds of breastfeeding cessation were observed among mothers who; were married, lived in larger households, lived in rural residences, whose children received vitamin A supplementation and among all other regions compared to Kampala.ConclusionOne in five mothers cessed breastfeeding before their child reached 2 years, with a significant increase in cessation odds among mothers of older children. These findings underscore the importance of interventions to promote breastfeeding continuation and adequate nutrition for non-breastfed infants, particularly in regions with high cessation rates.

Socio-demographic and economic profile of households with catastrophic health expenditures in Muanda, Boma and Matadi in 2022: a household cross-sectional study

Background Catastrophic health expenditures are direct healthcare expenses that exceed 10% or 25% of total household income. The present study aims to measure the proportion of households that fall into catastrophic health expenditure, their socio-demographic and economic characteristics and the factors associated with catastrophic health expenditures. Methods We conducted a secondary data analysis of 205 households from a cross-sectional study in seven health zones in 2022 in DRC. A Clustered Lot Quality Assurance Sampling (LQAS) was used through a 3-stage sampling process. Data were entered into SPSS version 26 and analyzed using the same software. Descriptive analyses included frequencies and percentages, bivariate analyses were performed to see the association between catastrophic health expenditure at 10% and 25% and the independent variables (location, household size, household head occupation, health insurance coverage, and economic well-being). Binary logistic regressions were performed respectively at the 10% and 25% thresholds of income. The association was statistically significant if the p-value was strictly less than 0.05. Results Overall, the extent of catastrophic expenditure at the 10% threshold was 72%, and 47% at the 25% threshold of the monthly household income. Poor households were 1.87 (95% confidence interval, CI=1.06-3.28) times more exposed to catastrophic expenditure than rich households. Conclusions In Kongo Central’s port area, catastrophic health expenditure prevalence is significantly higher than in Sub-Saharan Africa. This exposes the majority to further poverty, highlighting the need for a healthcare coverage system in the country. Registration: ESP/CE/118/2022 of September 12, 2022

Prevalence of and factors associated with zero-dose and under-immunized children in selected areas of Bangladesh: Findings from Lot Quality Assurance Sampling Survey

BackgroundIn the era of Gavi’s 5.0 vision of “leaving no one behind with immunization”, childhood routine vaccination in missed communities is considered as a priority concern. Despite having a success story at the national level, low uptake of immunization is still persistent in selected pocket areas of Bangladesh. However, prevalence and the associated factors of zero-dose (ZD) and under-immunization (UI) are still unknown at those geo-pockets of Bangladesh. Thus, the study aims to report and identify the factors associated with ZD and UI in selected geographical locations. MethodsThis study used data from a Lot Quality Assurance Sampling (LQAS) survey where 504 households from 18 clusters of four hard to reach (HTR) and one urban slum were included. Caregivers of children aged 4.5 to 23 months were interviewed. Three outcome variables- ZD, UI and ZD/UI were considered and several related attributes were considered as independent variables. Data were analyzed through bivariate analysis, binary logistic regression and dominance analysis. ResultsOverall, 32% of the children were either ZD (8%) or UI (26%) in the selected areas. The adjusted odds of ZD/UI for urban slum and haor (wetlands) areas were 5.62 and 3.61 respectively considering coastal areas as reference. However, distance of nearest EPI center, availability of EPI card, age of caregivers, education and occupation of mother and number of earning members in household were influential factors for ZD/UI. According to dominance analysis, availability of EPI card can explain the most of the variation of ZD/UI in this study. ConclusionThe study findings highlight the high prevalence ZD/UI in certain geo-pockets of the country. It provided a powerful insight of current situation and associated factors in regards to ZD/UI in the country which will help policy-makers and programme managers in designing programmes to reduce missed communities in Bangladesh.

Use of a fractional dose of inactivated polio vaccine (fIPV) to increase IPV coverage among children under 5 years of age in Somalia

BackgroundGlobal efforts reduced incidence of polio cases from 350,000 in 1988 to 22 cases in 2022 globally. There have been no wild poliovirus (WPV) cases seen in Somalia since August 2014. However, in 2017, there was a surge in the number of cases of circulating vaccine-derived poliovirus type 2 (cVDPV2), even with different intervention responses using monovalent oral polio vaccine type 2 (mOPV2). This study aimed to assess the use of fractional inactivated polio vaccine (fIPV), a smaller dose of the polio vaccine, equal to 1/5 of a standard dose, as an innovative polio vaccination delivery model, and identify the main opportunities for and challenges to the use of fIPV in the future for vaccinations.MethodsThe study used two designs: a quasi-experimental design used to pilot fIPV in five districts and a cross-sectional study using both quantitative and qualitative approaches to collect primary data. A simple random sampling method was used to select 2 out of the 5 pilot districts for household surveys to study 768 participants. Key informant interviews and focus-group discussions were used to collect data from key frontline health workers and health/immunization officials involved in the campaigns. Secondary data from the pilot campaigns were analysed, such as administrative pilot data, lot quality assurance sampling (LQAS) and post-campaign communication assessments.ResultsA total of 131,789 children aged 4–59 months were included for the pilot. Among these, 126,659 (96.1%) and 126,063 (95.6%) children were vaccinated in rounds 1 and 2, respectively. Out of the 768 households assessed, 99.9% had their children vaccinated. Nearly half of the few children who were not vaccinated were reported to be due to the parent of the child not being at home (48%). Ninety-seven percent of the qualitative study interviewees were satisfied with fIPV injection and recommended its use for routine immunization.ConclusionsThe study findings are promising in the use of fIPV in mass campaigns to realize better coverage and global polio eradication. fIPV will potentially be used by policymakers in the design of polio eradication campaigns that integrate the fIPV vaccine into routine or supplementary immunization.

Prevalence and determinants of minimum dietary diversity for women of reproductive age in Uganda

BackgroundGlobally, over a billion women of reproductive age (WRA) suffer from some kind of undernutrition micronutrient deficiencies, and/or anemia as a result of inadequate dietary diversity. This leads to poor maternal and child health outcomes, however, there is limited research on population level research on minimum dietary diversity for women (MDD-W). This study assessed the prevalence and predictors of MDD-W among WRA in Uganda.MethodsThis study was a secondary analysis of data from the lot quality assurance sampling (LQAS) survey conducted across 55 Ugandan districts between May and September 2022. Women of various ages were interviewed across 5 study subgroups that this study used to construct its study population (WRA). Descriptive analyses, tests for outcome differences, and multilevel mixed-effects logistic regression were conducted at a 5% statistical significance level using STATA version 17. The results were reported using Adjusted Odds Ratios (aOR) as the measure of the outcome.ResultsThe study analyzed responses from 29,802 WRA with a mean age of 27.8 (± 6.8) years. Only 8.8% (95% CI 8.5–9.3) achieved the MDD-W, the least proportion was observed in the South-Central region (3.13%). In the adjusted analysis, WRA who were older than 25 years (aOR 1.1, 95% CI 1.1–1.3, p < 0.001), had secondary education (aOR = 1.4, 95% CI 1.1–1.7, p = 0.003) or above (aOR = 1.7, 95% CI 1.3–2.2, p < 0.001), and used modern contraceptives (aOR = 1.1, 95% CI 1.0-1.3, p = 0.01) were more likely to achieve the MDD-W. Conversely, WRA who travelled longer distances to the nearest household water source (aOR = 0.8, 95% CI 0.7–0.9, p = 0.002) and those residing in larger households (aOR = 0.9, 95% CI 0.8-1.0, p = 0.019) were less likely to achieve the MDD-W.ConclusionA low proportion of WRA met the MDD-W. Age, education level, household sizes and use of modern contraception were predictors of MDD-W among WRA in Uganda. MDD-W-related program efforts in Uganda should strengthen multisectoral collaboration with prioritization of younger women, education, household sizes and access to safe water sources.

Wide metabolite coverage LC-MS/MS assay for the diagnosis of inherited metabolic disorders in urine

ObjectiveThe laboratory diagnosis of inherited metabolic disorders (IMD) has undergone significant development in recent decades, mainly due to the use of mass spectrometry, which allows rapid multicomponent analysis of a wide range of metabolites. Combined with advanced software tools, the diagnosis becomes more efficient as a benefit for both physicians and patients. MethodsA hydrophilic interaction liquid chromatography coupled with tandem mass spectrometry assay for determination of urinary purines, pyrimidines, N-acylglycines, N-acetylated amino acids, sugars, sugar alcohols and other diagnostically important biomarkers was developed and validated. Evaluation of the results consisting of utilisation of robust scaling and advanced visualization tools is simple and even suitable for urgent requirements. ResultsThe developed method, covering 65 biomarkers, provides a comprehensive diagnostic platform for 51 IMD. For most analytes, linearity with R2 > 0.99, intra and inter-day accuracy between 80 and 120 % and precision lower than 20 % were achieved. Diagnostic workflow was evaluated on 47 patients and External Quality Assurance samples involving a total of 24 different IMD. Over seven years, more than 2300 urine samples from patients suspected for IMD have been routinely analysed. ConclusionsThis method offers the advantage of a broad coverage of intermediate metabolites of interest and therefore may be a potential alternative and simplification for clinical laboratories that use multiple methods for screening these markers.

Coverage of Child Disability Detection, Management, and Rehabilitation Health Services in Central Uganda.

Child disability is a significant public health concern which impacts 1 in 20 children. Children with disabilities (CwDs) encounter deprivation of rights, biases in society, and a lack of access to necessary services, all of which are exacerbated by structural obstacles. This study assessed the coverage of child disability prevention, management and rehabilitation services in four districts of Central Uganda after two years of interventions to improve these services. The Lot Quality Assurance Sampling (LQAS) rapid health facility assessment method was employed to assess coverage of services based on sixteen indicators. The indicators were set based on constructs of: provision of disability-related services to CwDs; use of rehabilitation services; readiness of the health facilities (HFs) to provide basic disability management and rehabilitation services; community structures for linkage to disability management and rehabilitation services; psychosocial support provision; and upholding and protecting the rights of CwDs. A district-level decision rule was set based on 80% coverage target. Despite the interventions, the services have yet to provide the desired level of benefit to CwDs and their caregivers. Out of the sixteen indicators for healthcare service coverage for CwDs, only three attained the 80% coverage target. The findings suggest that greater focus by health service planners and project implementers is still needed, especially at the community and health facility levels to enhance the prevention, management and rehabilitation of CwDs. Psychosocial health services for caregivers of CwDs need special attention in order to achieve better service approaches.

Evaluating Antiretroviral Therapy Service Delivery Models Through Lot Quality Assurance Sampling in Central Uganda.

This study evaluated the effectiveness and responsiveness of differentiated Human Immunodeficiency Virus (HIV)/Acquired Immuno-Deficiency Syndrome (AIDS) service delivery models (DSDMs) implemented to enhance antiretroviral therapy (ART) access and outcomes for patients while addressing Tuberculosis (TB)-HIV integration, focusing on four of the five DSDMs currently implemented in Uganda. A descriptive cross-sectional survey was conducted in eight districts of central Uganda using Lot Quality Assurance Sampling approach from 7th to 23rd March 2023. We randomly sampled 2668 patients who have been on ART for at least 1 year in a Facility-Based Individual Management (FBIM) model or in a non-FBIM DSDM for at least one year. Data were collected through patient interviews and review of records in ART and DSDM registers as well as ART cards. We analyzed the data in proportions, comparing the selected ART outcome and responsiveness indicators between Community Client Led ART Distribution (CCLAD), Community Drugs Distribution Point (CDDP) and Fast-Track Drug Refill (FTDR) DSDMs with the standard care (FBIM) model. The ART outcome variables include patients retained in the 1st line of the ART regimen, patients in World Health Organization clinical stage 1 during the last facility visit, patients who had no CD4 request during the past 12 months, viral load suppression, ART adherence, and patients who reported that they did not experience HIV/AIDS-related symptoms in the past 6 months. The variables on TB care include screening for TB using the intensified case finding form and patients tested positive for TB. Responsiveness variables include the perceived; travel time for ART refill, travel distance for ART refill, convenience and flexibility during ART refill, cost of travel for ART refill, fear of being seen at ART refill point, waiting time before service, adequacy of service time, crowding and risk of infections, social support, ability to address ART treatment challenges, HIV status disclosure and barriers to access. Non-overlap in 95% confidence interval in indicator proportion between non-FBIM DSDM and FBIM means a statistically significant difference in proportion, or otherwise non-significant. Higher proportions of ART patients in the CCLAD and CDDP DSDMs adhered to ART, had suppressed viral load, and a lower TB prevalence than those in FBIM model. Additionally, more CCLAD and CDDP clients reported shorter travel time and distance to access ART than their counterparts in the FBIM model. Compared to FBIM model, higher proportions of those in CCLAD and CDDP also reported flexibility in ART refill scheduling, reduced transport costs, fewer privacy concerns, less HIV/AIDS-related stigma, shorter waiting times, more efficient services, decreased congestion at ART pickup sites, enhanced peer support, improved problem-solving assistance, and increased HIV status disclosure. The FTDR model outperformed FBIM in proportions with fewer requests for CD4 testing, viral load suppression, as well as proportions of clients who reported; shorter travel time, lower transportation cost, decreased privacy concerns, shorter waiting time, and efficient service provision. Compared to both CDDP and FTDR, the FBIM had a higher proportion of clients remain on the first-line ART regimen. Community-based DSDMs show responsiveness to clients' needs without compromising the effectiveness of ART care for patients. Although FTDR also demonstrates high effectiveness and responsiveness for clients on ART, there is potential for further improvement. Planners and implementers of ART programs should consider both demand- and supply-side innovations to sustain the continuation of DSDMs.

Sociodemographic and health-related factors associated with exclusive breastfeeding in 77 districts of Uganda

BackgroundUganda surpasses many African nations and the global average in exclusive breastfeeding (EBF) rates. Yet, malnutrition is a critical issue, with stunting impacting roughly 29% of children under 5 years. Enhancing EBF could mitigate such nutritional challenges. This study focused on determining the current EBF prevalence and identifying associated factors across 77 surveyed districts.MethodsPooled data from the Lot Quality Assurance Sampling (LQAS) surveys conducted in 77 districts in Uganda during 2021 and 2022 were analyzed. The analysis involved 7,210 mothers of children under 6 months, EBF was considered as the proportion of infants who received breast milk only in the 24 hours before the survey. A mother practicing EBF was (1) currently breastfeeding (2) had not started giving foods other than breastmilk (3) had not given any other probed liquids or (4) semi-solid foods the previous day or night. Multivariable logistic regression was used to identify factors associated with EBF, presenting adjusted odds ratios (aOR) with corresponding 95% confidence intervals at a 5% significance level.ResultsThe prevalence of EBF was 62.3%. In the adjusted analysis, EBF was more common among older mothers 20–24 years, 25–29 years and 30 + years (aOR 1.4; 95% CI 1.2,1.6), (aOR 1.4; 95% CI 1.1, 1.6) and (aOR 1.3; 95% CI 1.1, 1.5) respectively compared to teenage mothers. Also, EBF was more likely among mothers who lived in rural areas compared to urban areas (aOR 1.1; 95% CI 1.0, 1.3) and those who attended antenatal care (ANC) (aOR 2.2; 95% CI 1.5, 3.1). On the contrary, EBF was less common for children aged 3–5 months compared to younger (aOR 0.5; 95% CI 0.5, 0.6) and children who had received Vitamin A supplementation (aOR 0.7; 95% 0.6, 0.8).ConclusionThe study suggests that most districts in Uganda might not have made significant strides in improving EBF rates over the last twenty years, pointing to possible ongoing hurdles that need urgent attention. Particularly, there’s a pressing need to focus on teenage mothers. Maintaining and strengthening programs that advocate EBF, such as ANC, is crucial to bridge the gaps and bring about more equitable rates among different groups.

Development of a second-tier method for C4, C5 and C2 acylcarnitine analysis in plasma

IntroductionAcylcarnitines are typically analyzed using either a flow injection analysis (FIA) method or liquid chromatography-mass spectrometry (LC-MS/MS) methods. The FIA method is a fast, efficient method, however it does not have the capability to separate compounds with the same molecular weight. These isobaric interferences can be removed by chromatographic separation with LC-MS/MS. In this study, we aimed to develop and optimize a qualitative LC-MS/MS method to separate the isobaric interferences for two-, four- and five-carbon acylcarnitines. MethodsThe samples were first prepared by acylcarnitine derivatization with butanolic HCl. The developed LC-MS/MS method is a combination of isocratic and gradient elution used to separate acylcarnitines. Multiple reaction monitoring was used for determination of precursor and product ions for each acylcarnitine species as well as known interferences used in our study. We used this method to analyze quality assurance and patient samples with elevated two-, four- and five-carbon acylcarnitines. ResultsButyryl- and isobutyrylcarnitines as well as valeryl- and isovalerylcarnitines were successfully separated using the developed method. This method was able also to separate and distinguish acetylcarnitine from glutamate interference that has been causing overestimation of acetylcarnitine. In patients, the dominant five-carbon acylcarnitine was found to be isovalerylcarnitine. We confirmed that the majority of analyzed patient samples had additional carnitine adducts present but not valerylcarnitine. Butyryl- and isobutyrylcarnitines, in variable ratios, were present in every patient sample. ConclusionWe developed a qualitative LC-MS/MS method for butyl-ester derivatized acylcarnitines, which can be used as a second-tier method for diagnosis and monitoring of various inborn errors of metabolism in our hospital network.

Caregiver acceptance of malaria vaccination for children under 5 years of age and associated factors: cross-sectional household survey, Guinea and Sierra Leone, 2022

BackgroundMalaria is a leading cause of death and reduced life span in Guinea and Sierra Leone, where plans for rolling out the malaria vaccine for children are being made. There is little evidence about caregiver acceptance rates to guide roll-out policies. To inform future vaccine implementation planning, this analysis aimed to assess potential malaria vaccine acceptance by caregivers and identify factors associated with acceptance in Guinea and Sierra Leone.MethodsA cross-sectional household survey using lot quality assurance sampling was conducted in three regions per country between May 2022 and August 2022. The first survey respondent in each household provided sociodemographic information. A household member responsible for childcare shared their likelihood of accepting a malaria vaccine for their children under 5 years and details about children’s health. The prevalence of caregiver vaccine acceptance was calculated and associated factors were explored using multivariable logistic regression modelling calculating adjusted odds ratios (aOR) with 95% confidence intervals (CI).ResultsCaregivers in 76% of 702 sampled households in Guinea and 81% of 575 households in Sierra Leone were accepting of a potential vaccine for their children. In both countries, acceptance was lower in remote areas than in urban areas (Guinea: aOR 0.22 [95%CI 0.09–0.50], Sierra Leone: 0.17 [0.06–0.47]). In Guinea, acceptance was lower among caregivers living in the richest households compared to the poorest households (0.10 [0.04–0.24]), among those whose children were tested for malaria when febrile (0.54 [0.34–0.85]) and in households adopting more preventative measures against malaria (0.39 [0.25–0.62]). Better knowledge of the cause of malaria infection was associated with increased acceptance (3.46 [1.01–11.87]). In Sierra Leone, vaccine acceptance was higher among caregivers living in households where the first respondent had higher levels of education as compared to lower levels (2.32 [1.05–5.11]).ConclusionIn both countries, malaria vaccine acceptance seems promising for future vaccine roll-out programmes. Policy makers might consider regional differences, sociodemographic factors, and levels of knowledge about malaria for optimization of implementation strategies. Raising awareness about the benefits of comprehensive malaria control efforts, including vaccination and other preventive measures, requires attention in upcoming campaigns.

A hierarchical model-based framework for evaluating probabilities of area-wide freedom from lymphatic filariasis infection based on sentinel site surveillance data

The design of population surveys to substantiate the elimination of disease transmission across large implementation units (IUs) has become important as many parasite control efforts approach their final stages. This is especially true for the global program to eliminate lymphatic filariasis (LF), which has successfully reduced infection prevalence in many endemic countries, such that the focus has shifted to how best to determine that the area-wide elimination of this macroparasitic disease has been achieved. The WHO has recommended a two-stage lot quality assurance sampling (LQAS) framework based on sampling children from selected clusters within an IU, called the Transmission Assessment Survey (TAS), for supporting such decision-making, but questions have emerged regarding the reliability of this strategy for assessing if LF transmission is broken effectively everywhere within an area. In this study, we develop and describe an alternative probabilistic framework that combines infection status information from longitudinal parasitological surveys of whole communities carried out in sentinel sites, imperfect diagnostic tests, and locally-applicable extinction thresholds predicted by transmission models, to overcome the problems associated with TAS. We applied the framework to LF infection and intervention data from the country of Malawi, and demonstrated how our hierarchical coupled model-sentinel site survey tool can be used to estimate the probability that LF transmission has occurred at the individual survey, village, and countrywide scales. We also further demonstrated how the framework can be used in conjunction with zonal or areal design prevalences to estimate the number of sentinel sites and durations of interventions required to acquire sufficiently high confidence that an area is free from infection. Our results indicate that the application of the spatially driven model-data freedom-from-infection tool developed here to follow up data from high-risk sentinel sites in a region may offer a highly cost-effective framework for guiding the making of high-fiducial and defensible area-wide LF intervention stopping decisions.

Validation of the Randox colorimetric assays for serum copper and zinc.

Serum copper and zinc are measured to assess deficiency and toxicity. Atomic absorption spectrophotometry and mass spectrometry methods are expensive and require highly trained staff. Colorimetric assays are available from Randox which are inexpensive and can be automated. We validated serum copper and zinc colorimetric assays on the Binding Site Optilite analyser including comparison with flame atomic absorption spectrophotometry (FAAS) and inductively coupled plasma-mass spectrometry (ICP-MS). Accuracy, imprecision, lower limit of quantitation, and linearity were ascertained. The impact of triglycerides, bilirubin, nickel, and iron on assay performance was also investigated. Comparison of results from colorimetric analysis of patient and external quality assurance samples with those obtained by FAAS and ICP-MS was undertaken. Intra-, and inter-assay imprecision was <9%. Serum copper and zinc assays were linear between 1.8-35.6 and 2.3-45.7 µmol/L, respectively. Agreement was good between colorimetry and FAAS (intercept = -0.7, slope = 1.04) and ICP-MS (intercept = 0.6, slope = 0.99) for serum copper in patients' samples. For serum zinc, agreement was poor between colorimetry and FAAS (intercept = 2.2, slope = 0.87) and ICP-MS (intercept = 1.9, slope = 0.98) in patients' samples. There was a poor concordance in assessment of hypozincaemia between colorimetry and FAAS/ICP-MS. The Randox colorimetric assay for serum copper on the Optilite is simple to perform, has a short analysis time, and measured concentrations compare well with FAAS and ICP-MS. Due to poor agreement with FAAS and ICP-MS, colorimetry is not suitable for the measurement of serum zinc.

Level of minimum acceptable diet and its associated factors among children aged 12-23 months in Ugandan districts.

Uganda has made notable progress in improving child nutrition indicators, albeit not fast enough to meet global targets. Navigating the landscape of child nutrition in Uganda demands attention, particularly in light of the necessity for a minimum acceptable diet (MAD) for children aged 12-23 months. While the focus on local nutritional planning is crucial, the absence of routine-specific nutritional status data creates a significant information gap. To bridge this void, this study used datasets from the 2021 Lot Quality Assurance Sampling (LQAS) survey. Data were analysed using multilevel mixed-effects logistic regression (clustering districts based on regional boundaries) at a 5% statistical significance level using STATA version 17. Of the 7,111 children surveyed, 3,256 (49.20%) received the minimum meal frequency, 695 (9.80%) received the minimum dietary diversity, and only 380 (5.34%) received the MAD. There was a notable variation in the proportion of children that received the MAD across regions and districts. Children living in urban areas, children whose mothers had a higher education, and children whose mothers had a diverse diet were more likely to receive the MAD. Children were less likely to receive the MAD if they lived in a household that did not receive a health worker visit within the year. These findings suggest a need to prioritize initiatives aimed at increasing dietary diversity among children in Uganda. This could be done through a variety of approaches, such as leveraging the use of home gardens to boost nutrition through diverse crop cultivation, demonstration gardens, and offering nutrition counselling through village health teams.

Green UPLC method for estimation of ciprofloxacin, diclofenac sodium, and ibuprofen with application to pharmacokinetic study of human samples

Investigation of a unique and fast method for the determination and separation of a mixture of three drugs viz., ciprofloxacin (CIP), Ibuprofen (IBU), and diclofenac sodium (DIC) in actual samples of human plasma. Also, the technique was used to look at their pharmacokinetics study. Hydrocortisone was chosen as the internal standard (IS). The drugs were chromatographically separated using an Acquity ultra-performance liquid chromatography UPLC ® BEH C18 1.7 µm (2.1 × 150 mm) column with a mobile phase composed of acetonitrile: water (65:35, v/v) adjusted to pH 3 with diluted acetic acid. Plasma proteins were precipitated with acetonitrile. The separated drugs ranged from 0.3 to 10, 0.2–11, and 1–25 µg/mL for CIP, IBU, and DIC, respectively. Calibration curves were discovered to achieve linearity with acceptable correlation coefficients (0.99%). Examination of quality assurance samples showed exceptional precision and accuracy. Following the successful application of this improved technique to plasma samples, the pharmacokinetic characteristics of each selected drug were evaluated using (UPLC) with UV detection at 210 nm. Two green metrics were applied, the Analytical Eco-scale and the Analytical GREEnness Calculator (AGREE). Separation was achieved in only 4-min analysis time. The method's validation agreed with the requirements of the FDA, and the results were sufficient.