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Oxford Centre for Tropical Medicine and Global Health
Rapid intrapartum test for maternal group B streptococcal colonisation and its effect on antibiotic use in labouring women with risk factors for early-onset neonatal infection (GBS2): cluster randomised trial with nested test accuracy study
Abstract Background Mother-to-baby transmission of group B Streptococcus (GBS) is the main cause of early-onset infection. We evaluated whether, in women with clinical risk factors for early neonatal infection, the use of point-of-care rapid intrapartum test to detect maternal GBS colonisation reduces maternal antibiotic exposure compared with usual care, where antibiotics are administered due to those risk factors. We assessed the accuracy of the rapid test in diagnosing maternal GBS colonisation, against the reference standard of selective enrichment culture. Methods We undertook a parallel-group cluster randomised trial, with nested test accuracy study and microbiological sub-study. UK maternity units were randomised to a strategy of rapid test (GeneXpert GBS system, Cepheid) or usual care. Within units assigned to rapid testing, vaginal-rectal swabs were taken from women with risk factors for vertical GBS transmission in established term labour. The trial primary outcome was the proportion of women receiving intrapartum antibiotics to prevent neonatal early-onset GBS infection. The accuracy of the rapid test was compared against the standard of selective enrichment culture in diagnosing maternal GBS colonisation. Antibiotic resistance profiles were determined in paired maternal and infant samples. Results Twenty-two maternity units were randomised and 20 were recruited. A total of 722 mothers (749 babies) participated in rapid test units; 906 mothers (951 babies) were in usual care units. There was no evidence of a difference in the rates of intrapartum antibiotic prophylaxis (relative risk 1.16, 95% CI 0.83 to 1.64) between the rapid test (41%, 297/716) and usual care (36%, 328/906) units. No serious adverse events were reported. The sensitivity and specificity measures of the rapid test were 86% (95% CI 81 to 91%) and 89% (95% CI 85 to 92%), respectively. Babies born to mothers who carried antibiotic-resistant Escherichia coli were more likely to be colonised with antibiotic-resistant strains than those born to mothers with antibiotic-susceptible E. coli. Conclusion The use of intrapartum rapid test to diagnose maternal GBS colonisation did not reduce the rates of antibiotics administered for preventing neonatal early-onset GBS infection than usual care, although with considerable uncertainty. The accuracy of the rapid test is within acceptable limits. Trial registration ISRCTN74746075. Prospectively registered on 16 April 2015
A rapid intrapartum test for group B Streptococcus to reduce antibiotic usage in mothers with risk factors: the GBS2 cluster RCT
Background Mother-to-baby transmission of group B Streptococcus (Streptococcus agalactiae) is the main cause of early-onset infection. Objectives We investigated if intrapartum antibiotic prophylaxis directed by a rapid intrapartum test reduces maternal and neonatal antibiotic use, compared with usual care (i.e. risk factor-directed antibiotics), among women with risk factors for vertical group B Streptococcus transmission, and examined the accuracy and cost-effectiveness of the rapid test. Design An unblinded cluster randomised controlled trial with a nested test accuracy study, an economic evaluation and a microbiology substudy. Setting UK maternity units were randomised to either a strategy of rapid test or usual care. Participants Vaginal and rectal swabs were taken from women with risk factors for vertical group B Streptococcus transmission in established term labour. The accuracy of the GeneXpert® Dx IV GBS rapid testing system (Cepheid, Maurens-Scopont, France) was compared with the standard of selective enrichment culture in diagnosing maternal group B Streptococcus colonisation. Main outcome measures Primary outcomes were rates of intrapartum antibiotic prophylaxis administered to prevent early-onset group B Streptococcus infection and accuracy estimates of the rapid test. Secondary outcomes were maternal antibiotics for any indication, neonatal antibiotic exposure, maternal antibiotic duration, neonatal group B Streptococcus colonisation, maternal and neonatal antibiotic resistance, neonatal morbidity and mortality, and cost-effectiveness of the strategies. Results Twenty-two maternity units were randomised and 20 were recruited. A total of 722 mothers (749 babies) participated in rapid test units and 906 mothers (951 babies) participated in usual-care units. There were no differences in the rates of intrapartum antibiotic prophylaxis for preventing early-onset group B Streptococcus infection in the rapid test units (41%, 297/716) compared with the usual-care units (36%, 328/906) (risk ratio 1.16, 95% confidence interval 0.83 to 1.64). There were no differences between the groups in intrapartum antibiotic administration for any indication (risk ratio 0.99, 95% confidence interval 0.81 to 1.21). Babies born in the rapid test units were 29% less likely to receive antibiotics (risk ratio 0.71, 95% confidence interval 0.54 to 0.95) than those born in usual-care units. The sensitivity and specificity of the rapid test were 86% (95% confidence interval 81% to 91%) and 89% (95% confidence interval 85% to 92%), respectively. In 14% of women (99/710), the rapid test was invalid or the machine failed to provide a result. In the economic analysis, the rapid test was shown to be both less effective and more costly and, therefore, dominated by usual care. Sensitivity analysis indicated potential lower costs for the rapid test strategy when neonatal costs were included. No serious adverse events were reported. Conclusions The Group B Streptococcus 2 (GBS2) trial found no evidence that the rapid test reduces the rates of intrapartum antibiotic prophylaxis administered to prevent early-onset group B Streptococcus infection. The rapid test has the potential to reduce neonatal exposure to antibiotics, but economically is dominated by usual care. The accuracy of the test is within acceptable limits. Future work The role of routine testing for prevention of neonatal infection requires evaluation in a randomised controlled trial. Trial registration Current Controlled Trials ISRCTN74746075. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 12. See the NIHR Journals Library website for further project information.
Geographical mapping and seroprevalence of Burkholderia pseudomallei amongst livestock species in Lao People's Democratic Republic.
The Gram-negative bacterium Burkholderia pseudomallei causes a severe infectious disease known as melioidosis in humans and animals. It is considered endemic in tropical countries, including Thailand, Lao PDR (Laos), and Northern Australia. B. pseudomallei is a saprophyte found in contaminated soil and surface water. Humans and animals can become infected via direct exposure to contaminated water or soil and inhalation of dust or water droplets. Despite the high morbidity and mortality rates of melioidosis, there is a lack of knowledge of its geographical distribution and seroprevalence, even within endemic countries, raising a significant public health concern. For a better understanding of melioidosis in livestock in Laos, both as an animal health concern and as an indicator of human risk, we collected serum samples from an abattoir monitoring program for B. pseudomallei antibody testing using the Indirect Haemagglutination Assay (IHA). Out of the 917 sera collected, major findings included the identification of a significant cluster (p = 0.041) in the southwest border region adjoining northeastern Thailand, in the province of Savannakhet in Laos. Sera collected in January 2020 had the highest B. pseudomallei seroprevalence (17.0%), and cattle had the highest seroprevalence (22.8%), followed by buffalo (19.7%) and swine (4.0%). The B. pseudomallei seroprevalence results among the common livestock species and the maps generated can assist with future monitoring, prevention, and detection of melioidosis in Laos.
Longitudinal tracking of healthcare professionals: a methodological scoping review
Background: Tracking and understanding the progress and experiences of health workers and the outcomes of workforce decisions are essential for evidence-based workforce planning. In this scoping review, we aim to identify longitudinal studies that prospectively tracked healthcare professionals and that specifically focused on workforce issues such as career preferences, choices, and working conditions, and summarise the different approaches and methods used for tracking. Methods: We searched MEDLINE, Embase, Global Health, PsycINFO, CINAHL, Education Resource Information Center (ERIC), EconLit and the Cochrane Library for articles published between 2000–2022 that longitudinally tracked doctors, nurses, midwives, physician associates/assistants. We further compared articles and conducted a back-and-forward citation search to identify longitudinal tracking studies which sometimes have multiple published articles. We developed a typology of the different tracking approaches, and summarised the major areas assessed and tracked by different studies. Results: We identified and analysed 263 longitudinal tracking studies. Based on population recruitment and follow-up methods, we grouped studies into seven categories (cohort studies, multiple-cohort studies, baseline and data linkage studies, baseline and short repeated measure studies, baseline-only studies, data linkage-only studies and repeated survey studies). The majority of studies included used a cohort or multiple-cohort design (n = 180), and several others also used data linkage (n = 45) and repeated measure approaches (n = 24). Sixty-two studies recruited participants while they were students and followed them until they became the active workforce, and nearly half of the included studies started directly from the active workforce stage. Most of the included studies examined workforce issues including employment status, preference or intention (to leave/remain/migrate, specific speciality or location etc.), and work environment, however there was a lack of widely used measurement tools for workforce issues. Additionally, nearly 40% examined wellbeing issues and a subset (20%) examined physical health in the context of workforce-related issues. Conclusion: We described a large number of different healthcare professional longitudinal tracking studies. In order for longitudinal tracking to contribute to effective workforce planning, we recommend employing a mix of cohort and data linkage approaches to collect data across the different stages of the workforce ‘working lifespan’, and using and continuing to test standardised measurement instruments to better capture experiences related to workforce and wellbeing.
Epidemiology of Burkholderia pseudomallei, Streptococcus suis, Salmonella spp., Shigella spp. and Vibrio spp. infections in 111 hospitals in Thailand, 2022
The information on notifiable diseases in low- and middle-income countries is often incomplete, limiting our understanding of their epidemiology. Our study addresses this knowledge gap by analyzing microbiology laboratory and hospital admission data from 111 of 127 public referral hospitals in Thailand, excluding Bangkok, from January to December 2022. We evaluated factors associated with the incidence of notifiable bacterial diseases (NBDs) caused by 11 pathogens; including Brucella spp., Burkholderia pseudomallei, Corynebacterium diphtheriae, Neisseria gonorrhoeae, Neisseria meningitidis, non-typhoidal Salmonella spp. (NTS), Salmonella enterica serovar Paratyphi, Salmonella enterica serovar Typhi, Shigella spp., Streptococcus suis, and Vibrio spp.. We used multivariable Poisson random-effects regression models. Additionally, we compared their yearly incidence rates in 2022 with those from 2012-2015 in hospitals where paired data were available. In 2022, the NBD associated with the highest total number of deaths was B. pseudomallei (4,407 patients; 1,219 deaths) infection, followed by NTS (4,501 patients; 461 deaths), S. suis (867 patients, 134 deaths) and Vibrio spp. (809 patients, 122 deaths) infection. The incidence rates of B. pseudomallei, S. suis and Vibrio spp. infections were highest in the northeast, upper central and west, respectively. The incidence rate of NTS infection was generally high across all geographical regions. The yearly incidence rates of B. pseudomallei and S. suis infections in 2022 were higher than those between 2012-2015, while those of fecal-oral transmitted NBDs including NTS infection, typhoid, shigellosis and vibriosis were lower. Overall, B. pseudomallei and S. suis infections are emerging and associated with a very high number of deaths in Thailand. Although the incidence of NTS infection and vibriosis are decreasing, they are still associated with a high number of cases and deaths. Specific public health interventions are warranted.
Prediction of PaO2 from SpO2 values in critically ill invasively ventilated patients: rationale and protocol for a patient-level analysis of ERICC, LUNG SAFE, PRoVENT and PRoVENT-iMiC (PRoPERLy II).
INTRODUCTION: In patients with acute respiratory distress syndrome (ARDS), mortality risk is typically assessed using the arterial partial pressure of oxygen (PaO2) divided by the fraction of inspired oxygen (FiO2), known as the PaO2/FiO2 ratio. Recently, the SpO2/FiO2 ratio, which uses peripheral oxygen saturation (SpO2) instead of PaO2, has been suggested as a reasonable alternative when there is little access to arterial blood gas analyses. Additionally, equations that predict PaO2 from SpO2 values could offer another viable method for assessment. AIM: To evaluate the accuracy of methods for predicting PaO2 from SpO2 values and compare risk stratification based on measured versus predicted PaO2/FiO2 ratios using a large database that harmonizes the individual data of patients included in four observational studies. METHODS AND ANALYSIS: The individual data from four observational studies ('Epidemiology of Respiratory Insufficiency in Critical Care study' [ERICC], 'Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure' [LUNG SAFE], 'PRactice of VENTilation in critically ill patients without ARDS' [PRoVENT], and 'PRactice of VENTilation in critically ill patients in Middle-income Countries' [PRoVENT-iMiC]) were harmonized and pooled into a database named 'PRoPERLy II'. The primary endpoint of this planned analysis will be the accuracy of currently available methods to predict PaO2 from SpO2 values. The secondary endpoint will be the accuracy of classification based on SpO2/FiO2 ratio and the predicted PaO2/FiO2 ratio. DISSEMINATION: Our planned analysis addresses a clinically important research question by comparing different equations for predicting PaO2 from SpO2 values.
Simplifying medicine dosing for children by harmonising weight bands across therapeutic areas.
Generally, dose recommendations for children are expressed as fixed dosing increments related to bodyweight, known as weight bands. The weight bands recommended in WHO treatment guidelines vary between diseases, leading to complexity and potential dosing errors when treating children for multiple diseases simultaneously. The introduction of a harmonised weight banding approach for orally administered drugs across disease areas could streamline dosing for young children, but implementing such an approach would require changes in current dosing recommendations. In this Health Policy, we describe the process we conducted to: identify therapeutic areas for harmonisation of weight bands; propose a harmonised weight-banding system to align with current use of weight bands in antibiotic guidance; and simulate the expected effect of dose adjustments due to weight-band harmonisation. Each step of this process, along with the effect and feasibility of weight-band harmonisation was discussed with clinical, policy, and pharmacology experts convened by WHO, representing four therapeutic areas: tuberculosis, HIV, malaria, and hepatitis C. Dosing according to harmonised weight bands across the targeted therapeutic areas was found to be feasible and should be considered for implementation by WHO disease programmes through their appropriate normative processes.