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Simon Mendelsohn (cohort 2015-2016) co-authored this publications reporting the findings of a study that found a host blood test that can find those at high risk of tuberculosis in people living with HIV.
Factors influencing health workers’ compliance with outpatient malaria ‘test and treat’ guidelines during the plateauing performance phase in Kenya, 2014–2016
Abstract Background Health workers’ compliance with outpatient malaria ‘test and treat’ guidelines has improved since 2010 but plateaued from 2014 at suboptimal levels in Kenya. This study examined the factors associated with high but suboptimal compliance levels at facilities with available malaria tests and drugs. Methods Data from four national, cross-sectional health facility surveys undertaken between 2014 and 2016 in Kenya were analysed. Association between 31 factors and compliance with malaria testing (survey range (SR): 65–69%) and no anti-malarial treatment for test negative patients (SR: 90–92%) were examined using multilevel logistic regression models. Results A total of 2,752 febrile patients seen by 594 health workers at 486 health facilities were analysed. Higher odds of malaria testing were associated with lake endemic (aOR = 12.12; 95% CI: 5.3–27.6), highland epidemic (aOR = 5.06; 95% CI: 2.7–9.5) and semi-arid seasonal (aOR = 2.07; 95% CI: 1.2–3.6) compared to low risk areas; faith-based (FBO)/ non-governmental organization (NGO)-owned compared to government-owned facilities (aOR = 5.80; 95% CI: 3.2–10.6); health workers’ perception of malaria endemicity as high-risk (aOR = 3.05; 95% CI: 1.8–5.2); supervision with feedback (aOR = 1.84; 95% CI: 1.2–2.9); access to guidelines (aOR = 1.96; 95% CI: 1.1–3.4); older patients compared to infants, higher temperature measurements and main complaints of fever, diarrhoea, headache, vomiting and chills. Lower odds of testing were associated with febrile patients having main complaints of a cough (aOR = 0.65; 95% CI: 0.5–0.9), a rash (aOR = 0.32; 95% CI: 0.2–0.7) or a running nose (aOR = 0.59; 95% CI: 0.4–0.9). Other factors associated with compliance with test negative results included the type of diagnostic test available at the facility, in-service training, health workers’ age, and correct knowledge of the targeted treatment policy. Conclusions To optimize outpatient malaria case-management, reduce testing compliance gaps and eliminate overtreatment of test negative patients, there is a need to focus on compliance within low malaria risk areas in addition to ensuring the universal and continuous availability of ‘test and treat’ commodities. Targeting of older and government health workers; dissemination of updated guidelines; and continuing with in-service training and supportive supervision with feedback is essential. Lastly, there is a need to improve health workers’ knowledge about malaria testing criteria considering their perceptions of endemicity.
Readiness of the Kenyan public health sector to provide pre‐referral care for severe paediatric malaria
AbstractObjectiveTo assess readiness among primary public health facilities in Kenya to provide pre‐referral antimalarials for severe malaria.MethodsNine national surveys of randomly selected primary public health facilities undertaken bi‐annually between 2017 and 2021 were analysed. The outcomes included the availability of pre‐referral antimalarial drugs at the health facilities and health worker knowledge of recommended pre‐referral treatment for severe malaria.ResultsA total of 1540 health workers from 1355 health facilities were interviewed. Injectable artesunate was available at 46%, injectable quinine at 7%, and artemether at 3% of the health facilities. None of the facilities had rectal artesunate suppositories in stock. A total of 960 (62%) health workers were trained on the use of injectable artesunate. 73% of the health workers who had ever referred a child with severe malaria were aware that artesunate was the recommended treatment, 49% said that intramuscular injection was the preferred route of administration, and 60% stated the correct dose. The overall knowledge level of the treatment policy was low at 21% and only slightly higher among trained than untrained health workers (24% vs 14%; p < 0.001) and those with access to guidelines versus those without access (29% vs 17%; p < 0.001).ConclusionsThe readiness of primary health facilities and health workers to deliver appropriate pre‐referral care to children with complicated malaria in Kenya is inadequate. Further investments are required to ensure (a) availability of nationally recommended pre‐referral antimalarials; (b) appropriate training and supervision in their administration, and (c) monitoring of the entire referral process.
Level and determinants of district primary healthcare system technical efficiency in Ghana: two-stage stochastic frontier analysis.
BackgroundPrimary healthcare (PHC) is critical towards achieving Universal Health Coverage (UHC). In Ghana, PHC is organised at the district level and plays a key role in the country's pursuit of UHC. However, many districts face challenges not only with limited resources but also with how effectively they are used. We examined how efficiently districts in Ghana use their health resources and what factors are associated with this efficiency.MethodsWe used a two-step stochastic frontier analysis model using data from 181 districts. The output variable was a composite coverage index derived from eight PHC service indicators for 2021, primarily reflecting maternal and child health and infectious disease services. Input variables included district health expenditure for 2020/2021 and the number of health facilities and clinical staff in 2021. We then assessed the associations between efficiency scores generated by the model and health systems, socioeconomic and demographic factors, such as health facility type, insurance coverage, literacy level, Gini coefficient, poverty incidence, urbanisation and population density.ResultsOn average, districts operated at 87% efficiency, with scores ranging from 65% to 99%. Two factors were associated with the efficiency. First, districts with a higher proportion of PHC facilities tended to use resources more efficiently (coeff=0.151; 95% CI=0.041 to 0.261). Second, districts with greater income inequality were less efficient, measured by the Gini coefficient (coeff=-0.858; 95% CI=-1.146 to -0.252).ConclusionDistricts in Ghana have the potential to improve PHC outputs by about 13% on average by better use of existing resources and addressing determinants of efficiency. Findings suggest that districts with a higher proportion of PHC facilities and lower income inequality tend to be more efficient. These patterns highlight the value of strengthening PHC infrastructure and pursuing equity-focused policies as part of strategies to enhance efficiency in district health systems.
Evaluating the impact, implementation experience and political economy of primary care networks in Kenya: protocol for a mixed methods study.
BackgroundPrimary care networks (PCNs) are increasingly being adopted in low- and middle-income countries (LMICs) to improve the delivery of primary health care (PHC). Kenya has identified PCNs as a key reform to strengthen PHC delivery and has passed a law to guide its implementation. PCNs were piloted in two counties in Kenya in 2020 and implemented nationally in October 2023. This protocol outlines methods for a study that examines the impact, implementation experience and political economy of the PCN reform in Kenya.MethodsWe will adopt the parallel databases variant of convergent mixed methods study design to concurrently but separately collect quantitative and qualitative data. The two strands will be mixed during data collection to refine questions, with findings triangulated during analysis and interpretation to provide a comprehensive understanding of PCN implementation. The quantitative study will use a controlled before and after study design and collect data using health facility and client exit surveys. The primary outcome measure will be the service delivery readiness of PHC facilities. We will use a random sample of 228 health facilities and 2560 clients in four currently implementing PCNs, four planning to implement and four control counties at baseline and post-implementation. We shall undertake a preliminary cross-sectional analysis of the data at baseline from October to December 2023, followed by a difference-in-difference analysis at the endline from October to December 2024 to compare the outcome differences between the intervention and control counties over a 12-month period. The qualitative study will include a cross-sectional process evaluation and political economy analysis (PEA) using document reviews and approximately 80 in-depth interviews with national and sub-national stakeholders. The process evaluation will assess the emergence of PCN reforms, the implementation experience, the mechanism of impact and how the context affects implementation and outcomes. The PEA will examine the interaction of structural factors, institutions and actors/stakeholders' interests and power relations in implementing PCNs. We will also examine the gendered effects of the PCNs, including power relations and norms, and their implications on PHC from the supply and demand sides. We shall undertake a thematic analysis of the qualitative data.DiscussionThis evaluation will contribute robust evidence on the impact, implementation experience, political economy and gendered implications of PCNs in a LMIC setting, as well as guide the refining of PCN implementation in Kenya and other LMICs implementing or planning to implement PCNs to enhance their effectiveness.
Antenatal care quality and detection of risk among pregnant women: An observational study in Ethiopia, India, Kenya, and South Africa.
BackgroundAntenatal care (ANC) is an essential platform to improve maternal and newborn health (MNH). While several articles have described the content of ANC in low- and middle-income countries (LMICs), few have investigated the quality of detection and management of pregnancy risk factors during ANC. It remains unclear whether women with pregnancy risk factors receive targeted management and additional ANC.Methods and findingsThis observational study uses baseline data from the MNH eCohort study conducted in 8 sites in Ethiopia, India, Kenya, and South Africa from April 2023 to January 2024. A total of 4,068 pregnant women seeking ANC for the first time in their pregnancy were surveyed. We built country-specific ANC completeness indices that measured provision of 16 to 22 recommended clinical actions in 5 domains: physical examinations, diagnostic tests, history taking and screening, counselling, and treatment and prevention. We investigated whether women with pregnancy risks tended to receive higher quality care and we assessed the quality of detection and management of 7 concurrent illnesses and pregnancy risk factors (anemia, undernutrition, obesity, chronic illnesses, depression, prior obstetric complications, and danger signs). ANC completeness ranged from 43% in Ethiopia, 66% in Kenya, 73% in India, and 76% in South Africa, with large gaps in history taking, screening, and counselling. Most women in Ethiopia, Kenya, and South Africa initiated ANC in second or third trimesters. We used country-specific multivariable mixed-effects linear regression models to investigate factors associated with ANC completeness. Models included individual demographics, health status, presence of risk factors, health facility characteristics, and fixed effects for the study site. We found that some facility characteristics (staffing, patient volume, structural readiness) were associated with variation in ANC completeness. In contrast, pregnancy risk factors were only associated with a 1.7 percentage points increase in ANC completeness (95% confidence interval 0.3, 3.0, p-value 0.014) in Kenya only. Poor self-reported health was associated with higher ANC completeness in India and South Africa and with lower ANC completeness in Ethiopia. Some concurrent illnesses and risk factors were overlooked during the ANC visit. Between 0% and 6% of undernourished women were prescribed food supplementation and only 1% to 3% of women with depression were referred to a mental health provider or prescribed antidepressants. Only 36% to 73% of women who had previously experienced an obstetric complication (a miscarriage, preterm birth, stillbirth, or newborn death) discussed their obstetric history with the provider during the first ANC visit. Although we aimed to validate self-reported information on health status and content of care with data from health cards, our findings may be affected by recall or other information biases.ConclusionsIn this study, we observed gaps in adherence to ANC standards, particularly for women in need of specialized management. Strategies to maximize the potential health benefits of ANC should target women at risk of poor pregnancy outcomes and improve early initiation of ANC in the first trimester.
Evaluating the effects, implementation experience and political economy of primary healthcare facility autonomy reforms within counties in Kenya: a mixed methods study protocol.
IntroductionThere is a growing emphasis on improving primary health care services and granting frontline service providers more decision-making autonomy. In October 2023, Kenya enacted legislation mandating nationwide facility autonomy. There is limited understanding of the effects of health facility autonomy on primary health care (PHC) facilities performance. It is recognized that stakeholder interests influence reforms, and gender plays a critical role in access to health and its outcomes. This protocol outlines the methods for a study that plans to evaluate the effects, implementation experience, political economy, and gendered effects of health facility autonomy reforms in Kenya.Methods and analysisThe research will use a before-and-after quasi-experimental study design to measure the effects of the reform on service readiness and service utilization, and a cross-sectional qualitative study to explore the implementation experience, political economy, and gendered effects of these reforms. Data to measure the effects of autonomy will be collected from a sample of 80 health facilities and 1600 clients per study arm. Qualitative interviews will involve approximately 83 facility managers and policymakers at the county level, distributed across intervening (36), and planning to intervene (36) counties. Additionally, 11 interviews will be conducted at the national level with representatives from the Ministry of Health, the National Treasury, the Controller of Budget, the Council of Governors, the Auditor General, and development partners. Given the uncertainty surrounding the implementation of the reforms, this study proposes two secondary designs in the event our primary design is not feasible - a cross-sectional study, and a quasi-experimental interrupted time series design. The study will use a difference-in-difference analysis for the quantitative component to evaluate the effects of the reforms, while using thematic analysis for the qualitative component to evaluate the political economy and the implementation experience of the reforms.Ethics and disseminationThis study was approved by the Kenya Medical Research Institute Scientific and Ethics Review Unit (KEMRI/SERU/CGMR-C/294/4708) and the National Commission for Science, Technology and Innovation (NACOSTI/P/23/28111). We plan to disseminate the findings through publications, policy briefs and dissemination workshops.
Factors associated with hospital length of stay in patients admitted with suspected malaria in Kenya: secondary analysis of a cross-sectional survey.
ObjectivesTo investigate factors associated with hospital length of stay (LOS) in patients admitted with suspected malaria using a competing risk approach.SettingCounty government referrals and major faith-based hospitals in Kenya in 2018.DesignSecondary analysis of a cross-sectional survey data.ParticipantsData were extracted from 2396 medical records of patients admitted with suspected malaria at 90 hospitals.Outcome measuresLOS, defined as time to discharge, was the primary event of interest, and time to death was the competing event against patient factors assessed during admission and hospitalisation.ResultsAmong the patients analysed, 2283 were discharged, 49 died and 64 were censored. The median LOS was 4 days (IQR: 3-6 days). The cumulative incidence of discharge significantly decreased (p<0.05) by 12.7% (subdistribution-HR (SDHR): 0.873; 95% CI 0.789 to 0.967) when the respiratory rate was assessed, by 14.1% (SDHR 0.859; 95% CI 0.754 to 0.978) when oxygen saturation was monitored, by 23.1% (SDHR 0.769; 95% CI 0.709 to 0.833) and 23.4% (SDHR 0.766; 95% CI 0.704 to 0.833) when haemoglobin/haematocrit and glucose/random blood sugar were performed, respectively, and by 30.4% (SDHR 0.696; 95% CI 0.626 to 0.774) when patients had at least one clinical feature of severe malaria. Conversely, patients with confirmed severe malaria and those treated with injectable artesunate had a significantly increased cumulative incidence of discharge by 21.4% (SDHR 1.214; 95% CI 1.082 to 1.362) and 33.9% (SDHR 1.339; 95% CI 1.184 to 1.515), respectively.ConclusionsFactors of inpatient clinical processes that influence hospital LOS were identified. These can be targeted during quality improvement interventions to enhance health service delivery in Kenya. Early recognition and appropriate management of the signs of malaria severity could greatly affect beneficial outcomes. Strengthening clinical practices and nursing care according to national case management guidelines should be a priority for malaria control managers in Kenya.
Cross-sectional study to predict subnational levels of health workers' knowledge about severe malaria treatment in Kenya.
ObjectivesThis study applied a Bayesian hierarchical ecological spatial model beyond predictor analysis to test for the best fitting spatial effects model to predict subnational levels of health workers' knowledge of severe malaria treatment policy, artesunate dosing, and preparation.SettingCounty referral government and major faith-based hospitals across 47 counties in Kenya in 2019.Design and participantsA secondary analysis of cross-sectional survey data from 345 health workers across 89 hospitals with inpatient departments who were randomly selected and interviewed.Outcome measuresThree ordinal outcome variables for severe malaria treatment policy, artesunate dose and preparation were considered, while 12 individual and contextual predictors were included in the spatial models.ResultsA third of the health workers had high knowledge levels on artesunate treatment policy; almost three-quarters had high knowledge levels on artesunate dosing and preparation. The likelihood of having high knowledge on severe malaria treatment policy was lower among nurses relative to clinicians (adjusted OR (aOR)=0.48, 95% CI 0.25 to 0.87), health workers older than 30 years were 61% less likely to have high knowledge about dosing compared with younger health workers (aOR=0.39, 95% CI 0.22 to 0.67), while health workers exposed to artesunate posters had 2.4-fold higher odds of higher knowledge about dosing compared with non-exposed health workers (aOR=2.38, 95% CI 1.22 to 4.74). The best model fitted with spatially structured random effects and spatial variations of the knowledge level across the 47 counties exhibited neighbourhood influence.ConclusionsKnowledge of severe malaria treatment policies is not adequately and optimally available among health workers across Kenya. The factors associated with the health workers' level of knowledge were cadre, age and exposure to artesunate posters. The spatial maps provided subnational estimates of knowledge levels for focused interventions.
Host Directed Therapies for Tuberculous Meningitis.
A dysregulated host immune response significantly contributes to morbidity and mortality in tuberculous meningitis (TBM). Effective host directed therapies (HDTs) are critical to improve survival and clinical outcomes. Currently only one HDT, dexamethasone, is proven to improve mortality. However, there is no evidence dexamethasone reduces morbidity, how it reduces mortality is uncertain, and it has no proven benefit in HIV co-infected individuals. Further research on these aspects of its use, as well as alternative HDTs such as aspirin, thalidomide and other immunomodulatory drugs is needed. Based on new knowledge from pathogenesis studies, repurposed therapeutics which act upon small molecule drug targets may also have a role in TBM. Here we review existing literature investigating HDTs in TBM, and propose new rationale for the use of novel and repurposed drugs. We also discuss host variable responses and evidence to support a personalised approach to HDTs in TBM.
Digital Health Policy and Programs for Hospital Care in Vietnam: Scoping Review
Background There are a host of emergent technologies with the potential to improve hospital care in low- and middle-income countries such as Vietnam. Wearable monitors and artificial intelligence–based decision support systems could be integrated with hospital-based digital health systems such as electronic health records (EHRs) to provide higher level care at a relatively low cost. However, the appropriate and sustainable application of these innovations in low- and middle-income countries requires an understanding of the local government’s requirements and regulations such as technology specifications, cybersecurity, data-sharing protocols, and interoperability. Objective This scoping review aims to explore the current state of digital health research and the policies that govern the adoption of digital health systems in Vietnamese hospitals. Methods We conducted a scoping review using a modification of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. PubMed and Web of Science were searched for academic publications, and Thư Viện Pháp Luật, a proprietary database of Vietnamese government documents, and the Vietnam Electronic Health Administration website were searched for government documents. Google Scholar and Google Search were used for snowballing searches. The sources were assessed against predefined eligibility criteria through title, abstract, and full-text screening. Relevant information from the included sources was charted and summarized. The review process was primarily undertaken by one researcher and reviewed by another researcher during each step. Results In total, 11 academic publications and 20 government documents were included in this review. Among the academic studies, 5 reported engineering solutions for information systems in hospitals, 2 assessed readiness for EHR implementation, 1 tested physicians’ performance before and after using clinical decision support software, 1 reported a national laboratory information management system, and 2 reviewed the health system’s capability to implement eHealth and artificial intelligence. Of the 20 government documents, 19 were promulgated from 2013 to 2020. These regulations and guidance cover a wide range of digital health domains, including hospital information management systems, general and interoperability standards, cybersecurity in health organizations, conditions for the provision of health information technology (HIT), electronic health insurance claims, laboratory information systems, HIT maturity, digital health strategies, electronic medical records, EHRs, and eHealth architectural frameworks. Conclusions Research about hospital-based digital health systems in Vietnam is very limited, particularly implementation studies. Government regulations and guidance for HIT in health care organizations have been released with increasing frequency since 2013, targeting a variety of information systems such as electronic medical records, EHRs, and laboratory information systems. In general, these policies were focused on the basic specifications and standards that digital health systems need to meet. More research is needed in the future to guide the implementation of digital health care systems in the Vietnam hospital setting.
Tuberculous meningitis: progress and remaining questions.
Tuberculous meningitis is a devastating brain infection that is caused by Mycobacterium tuberculosis and is notoriously difficult to diagnose and treat. New technologies characterising the transcriptome, proteome, and metabolome have identified new molecules and pathways associated with tuberculous meningitis severity and poor outcomes that could offer novel diagnostic and therapeutic targets. The next-generation GeneXpert MTB/RIF Ultra assay, when used on CSF, offers diagnostic sensitivity for tuberculous meningitis of approximately 70%, although it is not widely available and a negative result cannot rule out tuberculous meningitis. Small trials indicate that clinical outcomes might be improved with increased doses of rifampicin, the addition of linezolid or fluoroquinolones to standard antituberculosis therapy, or treatment with adjunctive aspirin combined with corticosteroids. Large phase 3 clinical trials are underway worldwide to address these and other questions concerning the optimal management of tuberculous meningitis; these studies also form a platform for studying pathogenesis and identifying novel diagnostic and treatment strategies, by allowing the implementation of new genomic, transcriptomic, proteomic, and metabolomic technologies in nested substudies.
Whole blood transcriptional profiles and the pathogenesis of tuberculous meningitis.
Mortality and morbidity from tuberculous meningitis (TBM) are common, primarily due to inflammatory response to Mycobacterium tuberculosis infection, yet the underlying mechanisms remain poorly understood. We aimed to uncover genes and pathways associated with TBM pathogenesis and mortality, and determine the best predictors of death, utilizing whole-blood RNA sequencing from 281 Vietnamese adults with TBM, 295 pulmonary tuberculosis (PTB), and 30 healthy controls. Through weighted gene co-expression network analysis, we identified hub genes and pathways linked to TBM severity and mortality, with a consensus analysis revealing distinct patterns between HIV-positive and HIV-negative individuals. We employed multivariate elastic-net Cox regression to select candidate predictors of death, then logistic regression and internal bootstrap validation to choose best predictors. Increased neutrophil activation and decreased T and B cell activation pathways were associated with TBM mortality. Among HIV-positive individuals, mortality associated with increased angiogenesis, while HIV-negative individuals exhibited elevated TNF signaling and impaired extracellular matrix organization. Four hub genes-MCEMP1, NELL2, ZNF354C, and CD4-were strong TBM mortality predictors. These findings indicate that TBM induces a systemic inflammatory response similar to PTB, highlighting critical genes and pathways related to death, offering insights for potential therapeutic targets alongside a novel four-gene biomarker for predicting outcomes.
Statistical analysis plan for the LAST ACT clinical trial; a Leukotriene A4 hydrolase Stratified non-inferiority Trial of Adjunctive Corticosteroids for HIV-negative adults with Tuberculous meningitis
Tuberculous meningitis (TBM) is the most severe form of tuberculosis. Corticosteroids are currently recommended as an adjunctive therapy in HIV-negative adults with TBM. However, benefit from corticosteroids in TBM may depend upon host leukotriene A4 hydrolase ( LTA4H ) genotype and the corresponding inflammatory phenotypes. This article describes the planned analyses for the primary publication of the results of the LAST ACT clinical trial (NCT03100786): ‘Leukotriene A4 hydrolase Stratified Trial of Adjunctive Corticosteroids for HIV-negative adults with Tuberculous meningitis’. The primary hypothesis addressed by the trial is that LTA4H genotype, in particular CC or CT genotype, determines whether adjunctive dexamethasone benefits or harms adults with TBM. The trial was an LTA4H genotype stratified, parallel group, randomised, double blind, placebo-controlled multi-centre Phase III trial of dexamethasone given for 6–8 weeks in addition to standard anti-tuberculosis drugs. LTA4H genotype (CC, CT, TT) was determined in all participants prior to randomisation; only those with CC or CT genotype were randomised to dexamethasone or placebo. All TT genotype participants received dexamethasone because prior data indicated survival was increased by dexamethasone in this genotype. The primary endpoint was all-cause death or new neurological event over the first 12 months after randomisation. We took a hybrid trial-design approach which aims to prove non-inferiority of placebo first but also allows claiming superiority of placebo in case dexamethasone causes substantial harm. This statistical analysis plan expands upon and updates the analysis plan outlined in the published study protocol.
A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial
TBM is the most severe form of tuberculosis. Clinical trial data are required to provide an evidence base for adjunctive dexamethasone in HIV-positive individuals with TBM, and to guide clinical practice. This document details the planned analyses at 12 months post randomisation for the ACT HIV clinical trial (NCT03092817); ‘a randomised double-blind placebo-controlled trial of adjunctive dexamethasone for the treatment of HIV co-infected adults with tuberculous meningitis (TBM)’. The primary endpoint of the ACT HIV trial is death (from any cause) over the first 12 months after randomisation. This statistical analysis plan expands upon and updates the analysis plan outlined in the published study protocol.