Gates Open Research最新文献

{"title":"The apparent burden of unexplained sudden infant deaths in Lusaka, Zambia: Findings from analysis of verbal autopsies","authors":"Godwin K. Osei-Poku, L. Mwananyanda, Patricia A Elliott, W. MacLeod, S. W. Somwe, R. Pieciak, C. Gill","doi":"10.12688/gatesopenres.14303.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14303.1","url":null,"abstract":"Background: The contribution of sudden unexpected infant death (SUID) has received little attention in global health. The objective of this study was to estimate the burden of SUID in Lusaka, Zambia. Methods: Verbal autopsies were conducted on infants who died in Lusaka, between 2017 and 2020.  From these, we performed a qualitative analysis of the free text narratives of the final series of events leading to each infant’s death and classified these as symptomatic deaths or SUID. Any narrative that described an infant who was otherwise healthy with no antecedent illness prior to death and found dead in bed after a sleep episode was classified as SUID. We used logistic regression to test for statistical differences between asymptomatic deaths and SUIDs on key infant, maternal and other risk factors of SUIDs. Results: Eight hundred and nine verbal autopsies were conducted with families of decedent infants younger than six months of age. A total of 92.6% (749/809) had presented with symptoms prior to death, whereas 7.4% (60/809) died without preceding symptoms or obvious cause of death. Of these, 16/60 were compatible with accidental suffocation deaths, and 54/60 appeared to be sudden infant death syndrome.  SUID deaths were concentrated in infants younger than two months of age with peak age of one to two months. Age at death was the only significant factor in multivariate analysis. Infants aged between one and two months had 2.84 increased odds of suspected SUIDs compared to infants in the first month of life (aOR = 2.84, 95% CI: 1.31, 6.16). Conclusions: Our findings suggest SUID could be accounting for a significant proportion of infant deaths in Zambia, but this cause of infant mortality is going unrecognized. Public health interventions in Zambia, and Africa more broadly, are likely overlooking SUIDs as an important cause of infant mortality.","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46173337","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The economic costs of malaria in pregnancy: evidence from four sub-Saharan countries","authors":"Laia Cirera, Charfudin Sacoor, Martin Meremikwu, Louise Ranaivo, Manu F. Manun’Ebo, Dachi Arikpo, Osvaledo Matavele, Victor Rafaralahy, Didier Ndombe, Clara Pons Duran, Maximo Ramirez, Francesco Ramponi, Raquel González, Christina Maly, Elaine Roman, Elisa Sicuri, Franco Pagnoni, Clara Menéndez","doi":"10.12688/gatesopenres.14375.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14375.1","url":null,"abstract":"<ns4:p><ns4:bold>Background</ns4:bold></ns4:p><ns4:p> Malaria in pregnancy is a major public health problem in sub-Saharan Africa (SSA), which imposes a significant economic burden. We provide evidence on the costs of malaria care in pregnancy to households and the health system in four high-burden countries in SSA. </ns4:p><ns4:p> <ns4:bold>Methods</ns4:bold></ns4:p><ns4:p> Household and health system economic costs associated with malaria control in pregnancy were estimated in selected areas of the Democratic Republic of Congo (DRC), Madagascar (MDG), Mozambique (MOZ) and Nigeria (NGA). An exit survey was administered to 2,031 pregnant women when leaving the antenatal care (ANC) clinic from October 2020 to June 2021. Women reported the direct and indirect costs associated to malaria prevention and treatment in pregnancy. To estimate health system costs, we interviewed health workers from 133 randomly selected health facilities. Costs were estimated using an ingredients-based approach.</ns4:p><ns4:p> <ns4:bold>Results </ns4:bold></ns4:p><ns4:p> Average household costs of malaria prevention per pregnancy were USD6.33 in DRC, USD10.06 in MDG, USD15.03 in MOZ and USD13.33 in NGA. Household costs of treating an episode of uncomplicated/complicated malaria were USD22.78/USD46 in DRC, USD16.65/USD35.65 in MDG, USD30.54/USD61.25 in MOZ and USD18.92/USD44.71 in NGA, respectively. Average health system costs of malaria prevention per pregnancy were USD10.74 in DRC, USD16.95 in MDG, USD11.17 in MOZ and USD15.64 in NGA. Health system costs associated with treating an episode of uncomplicated/complicated malaria were USD4.69/USD101.41 in DRC, USD3.61/USD63.33 in MDG, USD4.68/USD83.70 in MOZ and USD4.09/USD92.64 in NGA. These estimates resulted in societal costs of malaria prevention and treatment per pregnancy of USD31.72 in DRC, USD29.77 in MDG, USD31.98 in MOZ and USD46.16 in NGA.</ns4:p><ns4:p> <ns4:bold>Conclusions</ns4:bold></ns4:p><ns4:p> Malaria in pregnancy imposes a high economic burden on households and the health system. Findings emphasize the importance of investing in effective strategies that improve access to malaria control and reduce the burden of the infection in pregnancy.</ns4:p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"285 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135583974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Uptake of same-day initiation of HIV treatment among adult men and women in Malawi, South Africa, and Zambia: the SPRINT retrospective cohort study","authors":"Amy Huber, Kamban Hirasen, Alana T. Brennan, Bevis Phiri, Timothy Tcherini, Lloyd Mulenga, Prudence Haimbe, Hilda Shakwelele, Rose Nyirenda, Bilaal Wilson Matola, Andrews Gunda, Sydney Rosen","doi":"10.12688/gatesopenres.14424.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14424.1","url":null,"abstract":"<ns4:p><ns4:bold>Background: </ns4:bold>Since 2017 global guidelines have recommended “same-day initiation” (SDI) of antiretroviral treatment (ART) for patients considered ready for treatment on the day of HIV diagnosis. Many countries have incorporated a SDI option into national guidelines, but SDI uptake is not well documented. We estimated average time to ART initiation at 12 public healthcare facilities in Malawi, five in South Africa, and 12 in Zambia.</ns4:p><ns4:p> <ns4:bold>Methods: </ns4:bold>We sequentially enrolled patients eligible to start ART between January 2018 and June 2019 and reviewed their medical records from the point of HIV diagnosis or first HIV-related interaction with the clinic to the earlier date of treatment initiation or 6 months. We estimated the proportion of patients initiating ART on the same day or within 7, 14, 30, or 180 days of baseline.</ns4:p><ns4:p> <ns4:bold>Results: </ns4:bold>We enrolled 826 patients in Malawi, 534 in South Africa, and 1,984 in Zambia. Overall, 88% of patients in Malawi, 57% in South Africa, and 91% in Zambia were offered and accepted SDI. In Malawi, most who did not receive SDI had not initiated ART ≤6 months. In South Africa, an additional 13% initiated ≤1 week, but 21% had no record of initiation ≤6 months. Among those who did initiate within 6 months in Zambia, most started ≤1 week. There were no major differences by sex. WHO Stage III/IV and tuberculosis symptoms were associated with delays in ART initiation.</ns4:p><ns4:p> <ns4:bold>Conclusions: </ns4:bold>As of 2020, SDI of ART was widespread, if not nearly universal, in Malawi and Zambia but considerably less common in South Africa. Limitations of the study include pre-COVID-19 data that do not reflect pandemic adaptations and potentially missing data for Zambia. South Africa may be able to increase overall ART coverage by reducing numbers of patients who do not initiate ≤6 months.</ns4:p><ns4:p> <ns4:bold>Registration:</ns4:bold> Clinicaltrials.gov (<ns4:ext-link xmlns:ns5=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" ns5:href=\"https://clinicaltrials.gov/show/NCT04468399\">NCT04468399</ns4:ext-link>; <ns4:ext-link xmlns:ns5=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" ns5:href=\"https://clinicaltrials.gov/show/NCT04170374\">NCT04170374</ns4:ext-link>; <ns4:ext-link xmlns:ns5=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" ns5:href=\"https://clinicaltrials.gov/show/NCT04470011\">NCT04470011</ns4:ext-link>).</ns4:p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"62 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135727867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Systematic review of diagnostic and prognostic host blood transcriptomic signatures of tuberculosis disease in people living with HIV","authors":"Simon C Mendelsohn, Savannah Verhage, Humphrey Mulenga, Thomas J Scriba, Mark Hatherill","doi":"10.12688/gatesopenres.14327.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14327.1","url":null,"abstract":"<ns4:p><ns4:bold>Background</ns4:bold></ns4:p><ns4:p> HIV-associated tuberculosis (TB) has high mortality; however, current triage and prognostic tools offer poor sensitivity and specificity, respectively. We conducted a systematic review of diagnostic and prognostic host-blood transcriptomic signatures of TB in people living with HIV (PLHIV).</ns4:p><ns4:p> </ns4:p><ns4:p> <ns4:bold>Methods</ns4:bold></ns4:p><ns4:p> We systematically searched online<ns4:italic> </ns4:italic>databases for studies published in English between 1990-2020. Eligible studies included PLHIV of any age in test or validation cohorts, and used microbiological or composite reference standards for TB diagnosis. Inclusion was not restricted by setting or participant age. Study selection, quality appraisal using the QUADAS-2 tool, and data extraction were conducted independently by two reviewers. Thereafter, narrative synthesis of included studies, and comparison of signatures performance, was performed.</ns4:p><ns4:p> </ns4:p><ns4:p> <ns4:bold>Results</ns4:bold></ns4:p><ns4:p> We screened 1,580 records and included 12 studies evaluating 31 host-blood transcriptomic signatures in 10 test or validation cohorts of PLHIV that differentiated individuals with TB from those with HIV alone, latent <ns4:italic>Mycobacterium tuberculosis</ns4:italic> infection, or other diseases (OD). Two (2/10; 20%) cohorts were prospective (29 TB cases; 51 OD) and 8 (80%) case-control (353 TB cases; 606 controls) design. All cohorts (10/10) were recruited in Sub-Saharan Africa and 9/10 (90%) had a high risk of bias. Ten signatures (10/31; 32%) met minimum WHO Target Product Profile (TPP) criteria for TB triage tests. Only one study (1/12; 8%) evaluated prognostic performance of a transcriptomic signature for progression to TB in PLHIV, which did not meet the minimum WHO prognostic TPP.</ns4:p><ns4:p> </ns4:p><ns4:p> <ns4:bold>Conclusions</ns4:bold></ns4:p><ns4:p> Generalisability of reported findings is limited by few studies enrolling PLHIV, limited geographical diversity, and predominantly case-control design, which also introduces spectrum bias. New prospective cohort studies are needed that include PLHIV and are conducted in diverse settings. Further research exploring the effect of HIV clinical, virological, and immunological factors on diagnostic performance is necessary for development and implementation of TB transcriptomic signatures in PLHIV.</ns4:p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"59 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135206595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Circumstances for treatment and control of invasive Enterobacterales infections in eight hospitals across sub-Saharan Africa: a cross-sectional study.","authors":"Alexander M Aiken, Brian Nyamwaya, Lola Madrid, Dumessa Edessa, Appiah-Korang Labi, Noah Obeng-Nkrumah, William Mwabaya, Mabvuto Chimenya, Derek Cocker, Kenneth C Iregbu, Philip I P Princewill-Nwajiobi, Angela Dramowski, Tolbert Sonda, Blandina Theophil Mmbaga, David Ojok, Sombo Fwoloshi, J Anthony G Scott, Andrew Whitelaw","doi":"10.12688/gatesopenres.14267.1","DOIUrl":"10.12688/gatesopenres.14267.1","url":null,"abstract":"<p><p><b>Background:</b> Bloodstream infections caused by Enterobacterales show high frequency of antimicrobial resistance (AMR) in many Low- and Middle-Income Countries. We aimed to describe the variation in circumstances for management of such resistant infections in a group of African public-sector hospitals participating in a major research study. <b>Methods:</b> We gathered data from eight hospitals across sub-Saharan Africa to describe hospital services, infection prevention and antibiotic stewardship activities, using two WHO-generated tools. We collected monthly cross-sectional data on availability of antibiotics in the hospital pharmacies for bloodstream infections caused by Enterobacterales. We compared the availability of these antibiotics to actual patient-level use of antibiotics in confirmed Enterobacterales bloodstream infections (BSI). <b>Results:</b> Hospital circumstances for institutional management of resistant BSI varied markedly. This included self-evaluated infection prevention level (WHO-IPCAF score: median 428, range 155 to 687.5) and antibiotic stewardship activities (WHO stewardship toolkit questions: median 14.5, range 2 to 23). These results did not correlate with national income levels. Across all sites, ceftriaxone and ciprofloxacin were the most consistently available antibiotic agents, followed by amoxicillin, co-amoxiclav, gentamicin and co-trimoxazole. There was substantial variation in the availability of some antibiotics, especially carbapenems, amikacin and piperacillin-tazobactam with degree of access linked to national income level. Investigators described out-of-pocket payments for access to additional antibiotics at 7/8 sites. The in-pharmacy availability of antibiotics correlated well with actual use of antibiotics for treating BSI patients. <b>Conclusions:</b> There was wide variation between these African hospitals for a range of important circumstances relating to treatment and control of severe bacterial infections, though these did not all correspond to national income level. For most antibiotics, patient-level use reflected in-hospital drug availability, suggesting external antibiotics supply was infrequent. Antimicrobial resistant bacterial infections could plausibly show different clinical impacts across sub-Saharan Africa due to this contextual variation.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":" ","pages":"21"},"PeriodicalIF":0.0,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10963387/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41959864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Maré cohort-profile: a prospective cohort study based in a socially vulnerable community during the COVID-19 pandemic in Rio de Janeiro, Brazil","authors":"Amanda A Batista-da-Silva, Olivia T Ranzani, Daniela M de Paulo, Mariana L Braunstein, Helena R Bozza, Ronald Fischer, Grazielle V Ramos, Carolina M C Dias, Everton P da Silva, Luna E Arouca, Leonardo L S Bastos, Otavio T Ranzani, S. Hamacher, Fernando A Bozza","doi":"10.12688/gatesopenres.14035.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14035.1","url":null,"abstract":"Background: Socially vulnerable populations were vastly affected by the COVID-19 pandemic. The pandemic significantly impacted Brazil, pressuring its healthcare system for several months, with high mortality rates, even among the youngest population. Cohort studies combining disease surveillance are essential for understanding virus circulation in the community, surrogates of protection, vaccine effectiveness, and demand for health resources. Methods: Here, we present the protocol for a community-based prospective cohort study in the largest complex of favelas (slums) in Rio de Janeiro, Brazil (Complexo da Maré). The study participants are residents initially recruited during a massive vaccination campaign in the community. Five waves of data collection at approximately six-month intervals were planned. The first two waves have been completed at the time of writing this study protocol, and the third is underway. The protocol comprises interviews, blood sampling, and records linkage with secondary data to enrich the profiles of cohort participants and community information. We will describe COVID-19 seroprevalence, socio-demographic characteristics, and the burden of COVID-19, followed by estimating the association of socioeconomic factors and the burden of disease with seroprevalence. Discussion: The primary aims of the study are to assess COVID-19 clinical, epidemiological and genomic profiles and outcomes in residents from Maré, including vaccine effectiveness, surrogates of immune protection, virus transmission in households, and the overall burden of the pandemic.","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42168736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A hybrid effectiveness-implementation study protocol to assess the effectiveness and chemoprevention efficacy of implementing seasonal malaria chemoprevention in five districts in Karamoja region, Uganda","authors":"R. Kajubi, J. Ainsworth, K. Baker, S. Richardson, C. Bonnington, C. Rassi, Jane Achan, Godfrey Magumba, Denis Rubahika, Jane Nabakooza, J. Tibenderana, A. Nuwa, J. Opigo","doi":"10.12688/gatesopenres.14287.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14287.1","url":null,"abstract":"Background: The World Health Organization (WHO) recommends seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine for children aged 3 to 59 months, living in areas where malaria transmission is highly seasonal. However, due to widespread prevalence of resistance markers, SMC has not been implemented at scale in East and Southern Africa. An initial study in Uganda showed that SMC with SPAQ was feasible, acceptable, and protective against malaria in eligible children in Karamoja region. Nonetheless, exploration of alternative regimens is warranted since parasite resistance threats persist. Objective: The study aims to test the effectiveness of SMC with DP or SPAQ (DP-SMC & SPAQ-SMC), chemoprevention efficacy as well as the safety and tolerability of DP compared to that of SPAQ among 3-59 months old children in Karamoja region, an area of Uganda where malaria transmission is highly seasonal. Methods: A Type II hybrid effectiveness-implementation study design consisting of four components: 1) a cluster randomized controlled trial (cRCT) using passive surveillance to establish confirmed malaria cases in children using both SPAQ and DP; 2a) a prospective cohort study to determine the chemoprevention efficacy of SPAQ and DP (if SPAQ or DP clears sub-patent  infection and provides 28 days of protection from new infection) and whether drug concentrations and/or resistance influence the ability to clear and prevent infection; 2b) a sub study examining pharmacokinetics of DP in children between 3 to <6 months; 3) a resistance markers study in children 3–59 months in the research districts plus the standard intervention districts to measure changes in resistance marker prevalence over time and finally; 4) a process evaluation. Discussion: This study evaluates the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. Conclusion: This study will inform malaria policy in high-burden countries and contribute to progress in malaria control.","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41742012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A case for vaccinating adolescent girls for protection against COVID-19 during pregnancy and childbirth in resource-limited settings","authors":"H. Blakeway, Lauren Hookham, E. Nakabembe, A. Koech, A. Khalil, S. Ladhani, M. Temmerman, K. Le Doare","doi":"10.12688/gatesopenres.13777.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.13777.1","url":null,"abstract":"The coronavirus disease 2019 (COVID-19) pandemic has had severe implications worldwide, including increased adverse maternal and neonatal health outcomes. Vaccination is one way of protecting against these adverse health outcomes. However, in some low-resource settings, vaccine inequity has led to poor uptake of COVID-19 vaccination. There are very high rates of adolescent pregnancy in low-resource settings, which are likely to become even higher as we begin to see the full effects of COVID-19 lockdown measures, including school closures. Although the benefits of COVID-19 vaccination in adolescents are debated, we propose that adolescent girls should be prioritised in COVID vaccination roll out in low-resource settings. This is to provide protection from severe COVID-19 disease in pregnancy, preventing adverse maternal and neonatal health outcomes.","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42540349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adaptive strategies for the deployment of rapid diagnostic tests for COVID-19: a modelling study","authors":"Lucia Cilloni, E. Kendall, D. Dowdy, N. Arinaminpathy","doi":"10.12688/gatesopenres.14202.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14202.1","url":null,"abstract":"Background: Lateral flow assays (LFAs) for the rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) provide an affordable, rapid and decentralised means for diagnosing coronavirus disease 2019 (COVID-19). Concentrating on urban areas in low- and middle-income countries, we examined whether ‘dynamic’ screening algorithms, that adjust the use of confirmatory polymerase chain reaction (PCR) testing based on epidemiological conditions, could reduce cost without substantially reducing the impact of testing. Methods: Concentrating on a hypothetical ‘second wave’ of COVID-19 in India, we modelled the potential impact of testing 0.5% of the population per day at random with LFA, regardless of symptom status. We considered dynamic testing strategies where LFA positive cases are only confirmed with PCR when LFA positivity rates are below a given threshold (relative to the peak positive rate at the height of the epidemic wave), compared to confirming either all positive LFA results or confirming no results. Benefit was estimated based on cumulative incidence of infection, and resource requirements, based on the cumulative number of PCR tests used and the cumulative number of unnecessary isolations. Results: A dynamic strategy of discontinuing PCR confirmation when LFA positivity exceeded 50% of the peak positivity rate in an unmitigated epidemic would achieve comparable impact to one employing PCR confirmation throughout (9.2% of cumulative cases averted vs 9.8%), while requiring 35% as many PCR tests. However, the dynamic testing strategy would increase the number of false-positive test results substantially, from 0.07% of the population to 1.1%. Conclusions: Dynamic diagnostic strategies that adjust to epidemic conditions could help maximise the impact of testing at a given cost. Generally, dynamic strategies reduce the number of confirmatory PCR tests needed, but increase the number of unnecessary isolations. Optimal strategies will depend on whether greater priority is placed on limiting confirmatory testing or false-positive diagnoses.","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41390861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tranexamic acid for the prevention of postpartum bleeding: Protocol for a systematic review and individual patient data meta-analysis","authors":"Katharine Ker, Haleema Shakur-Still, Loïc Sentilhes, Luis D. Pacheco, George Saade, Catherine Deneux-Tharaux, Amy Brenner, Raoul Mansukhani, François-Xavier Ageron, Danielle Prowse, Rizwana Chaudhri, Oladapo Olayemi, Ian Roberts","doi":"10.12688/gatesopenres.13747.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.13747.1","url":null,"abstract":"<ns4:p><ns4:bold>Background</ns4:bold>: Tranexamic acid (TXA) reduces the risk of death and is recommended as a treatment for women with severe postpartum bleeding. There is hope that giving TXA shortly before or immediately after birth could prevent postpartum bleeding. Extending the use of TXA to prevent harmful postpartum bleeding could improve outcomes for millions of women; however, we must carefully consider the balance of benefits and potential harms. This article describes the protocol for a systematic review and individual patient data (IPD) meta-analysis to assess the effectiveness and safety of TXA for preventing postpartum bleeding, and to explore how the effects vary by underlying risk and other patient characteristics.</ns4:p><ns4:p> <ns4:bold>Methods</ns4:bold>: We will search for prospectively registered, randomised controlled trials involving 500 patients or more assessing the effects of TXA in women giving birth. Two authors will extract data and assess risk of bias. IPD data will be sought from eligible trials. Primary outcomes will be life-threatening bleeding and thromboembolic events. We will use a one-stage model to analyse the data. Subgroup analyses will be conducted to explore whether the effectiveness and safety of TXA varies by underlying risk, type birth, maternal haemoglobin (Hb), and timing of TXA. </ns4:p><ns4:p> <ns4:bold>Conclusions</ns4:bold>: This systematic review and IPD meta-analysis will address important clinical questions about the effectiveness and safety of the use of TXA for the prevention of postpartum bleeding that cannot be answered reliably using aggregate data and will inform the decision of who to treat.</ns4:p><ns4:p> </ns4:p><ns4:p> PROSPERO registration: CRD42022345775</ns4:p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135250700","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}