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1.
Nutr Rev ; 2024 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-38950419

RESUMEN

CONTEXT: Previous research linked vitamin D deficiency in pregnancy to adverse pregnancy outcomes. OBJECTIVE: Update a 2017 systematic review and meta-analysis of randomized controlled trials (RCTs) on the effect of vitamin D supplementation during pregnancy, identify sources of heterogeneity between trials, and describe evidence gaps precluding a clinical recommendation. DATA SOURCES: The MEDLINE, PubMed, Europe PMC, Scopus, Cochrane Database of Systematic Reviews, Web of Science, and CINAHL databases were searched. Articles were included that reported on RCTs that included pregnant women given vitamin D supplements as compared with placebo, no intervention, or active control (≤600 IU d-1). Risk ratios (RRs) and mean differences were pooled for 38 maternal, birth, and infant outcomes, using random effects models. Subgroup analyses examined effect heterogeneity. The Cochrane risk of bias tool was used. DATA EXTRACTION: Included articles reported on a total of 66 trials (n = 17 276 participants). DATA ANALYSIS: The median vitamin D supplementation dose was 2000 IU d-1 (range: 400-60 000); 37 trials used placebo. Antenatal vitamin D supplementation had no effect on the risk of preeclampsia (RR, 0.81 [95% CI, 0.43-1.53]; n = 6 trials and 1483 participants), potentially protected against gestational diabetes mellitus (RR, 0.65 [95% CI, 0.49-0.86; n = 12 trials and 1992 participants), and increased infant birth weight by 53 g (95% CI, 16-90; n = 40 trials and 9954 participants). No effect of vitamin D on the risk of preterm birth, small-for-gestational age, or low birth weight infants was found. A total of 25 trials had at least 1 domain at high risk of bias. CONCLUSION: Additional studies among the general pregnant population are not needed, given the many existing trials. Instead, high-quality RCTs among populations with low vitamin D status or at greater risk of key outcomes are needed. Benefits of supplementation in pregnancy remain uncertain because current evidence has high heterogeneity, including variation in study context, baseline and achieved end-line 25-hydroxyvitamin D level, and studies with high risk of bias. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42022350057.

2.
PLoS One ; 19(6): e0304165, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38913675

RESUMEN

BACKGROUND: There is limited understanding of how social determinants of health (SDOH) impact family decision-making when seeking surgical care for children. Our objectives of this study are to identify key family experiences that contribute to decision-making when accessing surgical care for children, to confirm if family experiences impact delays in care, and to describe differences in family experiences across populations (race, ethnicity, socioeconomic status, rurality). METHODS: We will use a prospective, cross-sectional, mixed methods design to examine family experiences during access to care for children with appendicitis. Participants will include 242 parents of consecutive children (0-17 years) with acute appendicitis over a 15-month period at two academic health systems in North Carolina and Virginia. We will collect demographic and clinical data. Parents will be administered the Adult Responses to Children's Symptoms survey (ARCS), the child and parental forms of the Adverse Childhood Experiences (ACE) survey, the Accountable Health Communities Health-Related Social Needs Screening Tool, and Single Item Literacy Screener. Parallel ARCS data will be collected from child participants (8-17 years). We will use nested concurrent, purposive sampling to select a subset of families for semi-structured interviews. Qualitative data will be analyzed using thematic analysis and integrated with quantitative data to identify emerging themes that inform a conceptual model of family-level decision-making during access to surgical care. Multivariate linear regression will be used to determine association between the appendicitis perforation rate and ARCS responses (primary outcome). Secondary outcomes include comparison of health literacy, ACEs, and SDOH, clinical outcomes, and family experiences across populations. DISCUSSION: We expect to identify key family experiences when accessing care for appendicitis which may impact outcomes and differ across populations. Increased understanding of how SDOH and family experiences influence family decision-making may inform novel strategies to mitigate surgical disparities in children.


Asunto(s)
Apendicitis , Toma de Decisiones , Accesibilidad a los Servicios de Salud , Humanos , Niño , Estudios Transversales , Adolescente , Preescolar , Masculino , Femenino , Apendicitis/cirugía , Lactante , Estudios Prospectivos , Padres/psicología , Recién Nacido , Familia/psicología , North Carolina , Virginia
3.
Pediatr Surg Int ; 40(1): 158, 2024 Jun 19.
Artículo en Inglés | MEDLINE | ID: mdl-38896255

RESUMEN

PURPOSE: Pediatric surgical care in low- and middle-income countries is often hindered by systemic gaps in healthcare resources, infrastructure, training, and organization. This study aims to develop and validate the Global Assessment of Pediatric Surgery (GAPS) to appraise pediatric surgical capacity and discriminate between levels of care across diverse healthcare settings. METHODS: The GAPS Version 1 was constructed through a synthesis of existing assessment tools and expert panel consultation. The resultant GAPS Version 2 underwent international pilot testing. Construct validation categorized institutions into providing basic or advanced surgical care. GAPS was further refined to Version 3 to include only questions with a > 75% response rate and those that significantly discriminated between basic or advanced surgical settings. RESULTS: GAPS Version 1 included 139 items, which, after expert panel feedback, was expanded to 168 items in Version 2. Pilot testing, in 65 institutions, yielded a high response rate. Of the 168 questions in GAPS Version 2, 64 significantly discriminated between basic and advanced surgical care. The refined GAPS Version 3 tool comprises 64 questions on: human resources (9), material resources (39), outcomes (3), accessibility (3), and education (10). CONCLUSION: The GAPS Version 3 tool presents a validated instrument for evaluating pediatric surgical capabilities in low-resource settings.


Asunto(s)
Países en Desarrollo , Recursos en Salud , Pediatría , Humanos , Proyectos Piloto , Pediatría/educación , Salud Global , Niño , Procedimientos Quirúrgicos Operativos , Especialidades Quirúrgicas/educación
4.
PLoS One ; 19(5): e0301081, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38820360

RESUMEN

BACKGROUND: Perinatal mortality remains a global challenge. This challenge may be worsened by the negative effects of the COVID-19 pandemic on maternal and child health. OBJECTIVES: Examine the impact of the COVID-19 pandemic on perinatal care and outcomes in the Tamale Teaching Hospital in northern Ghana. METHODS: A hospital-based retrospective study was conducted in the Tamale Teaching Hospital. We compared antenatal care attendance, total deliveries, cesarean sections, and perinatal mortality before the COVID-19 pandemic (March 1, 2019 to February 28, 2020) and during the COVID-19 pandemic (March 1, 2020 to February 28, 2021). Interrupted time series analyses was performed to evaluate the impact of the COVID-19 pandemic on perinatal care and outcomes at TTH. RESULTS: A total number of 35,350 antenatal visits and 16,786 deliveries were registered at TTH from March 2019 to February 2021. Antenatal care, early neonatal death, and emergency cesarean section showed a rapid decline after the onset of the pandemic, with a progressive recovery over the following months. The total number of deliveries and fresh stillbirths showed a step change with a marked decrease during the pandemic, while the macerated stillbirths showed a pulse change, a temporary marked decrease with a quick recovery over time. CONCLUSION: The COVID-19 pandemic had a negative impact on perinatal care and outcomes in our facility. Pregnancy monitoring through antenatal care should be encouraged and continued even as countries tackle the pandemic.


Asunto(s)
COVID-19 , Atención Perinatal , Mortalidad Perinatal , Centros de Atención Terciaria , Humanos , Ghana/epidemiología , Femenino , Embarazo , COVID-19/epidemiología , Estudios Retrospectivos , Atención Perinatal/estadística & datos numéricos , Recién Nacido , Adulto , Cesárea/estadística & datos numéricos , Atención Prenatal/estadística & datos numéricos , Pandemias , SARS-CoV-2/aislamiento & purificación , Mortinato/epidemiología , Resultado del Embarazo/epidemiología , Parto Obstétrico/estadística & datos numéricos
5.
BMC Cancer ; 24(1): 457, 2024 Apr 12.
Artículo en Inglés | MEDLINE | ID: mdl-38609910

RESUMEN

INTRODUCTION: The SARS-CoV-2 (COVID-19) pandemic has strained healthcare systems and presented unique challenges for children requiring cancer care, particularly in low- and middle-income countries. This study aimed to assess the impact of the COVID-19 pandemic on access to cancer care for children and adolescents in Northern Tanzania. METHODS: In this cross-sectional study, we assessed the demographic and clinical characteristics of 547 pediatric and adolescent cancer patients (ages 0-19 years old) between 2016 and 2022 using the population-based Kilimanjaro Cancer Registry (KCR). We categorized data into pre-COVID-19 (2016-2019) and COVID-19 (2020-2022) eras, and performed descriptive analyses of diagnostic, treatment, and demographic information. A secondary analysis was conducted on a subset of 167 patients with stage of diagnosis at presentation. RESULTS: Overall admissions nearly doubled during the pandemic (n = 190 versus 357). The variety of diagnoses attended at KCMC increased during the pandemic, with only five groups of diseases reported in 2016 to twelve groups of diseases in 2021. Most patients were diagnosed at a late stage (stage III or IV) across eras, with the proportion of under-five years old patients increasing late-diagnoses from 29.4% (before the pandemic), 52.8% (during the pandemic), when compared to the overall cohort. Around 95% of children in this age category reported late-stage diagnosis during the pandemic. Six out of the twelve cancer site groups also reported an increase in late-stage diagnosis. During the pandemic, the proportion of children receiving surgery increased from 15.8 to 30.8% (p < 0.001). CONCLUSION: Childhood and adolescent cancer care changed in Northern Tanzania during the COVID-19 pandemic, with increased late-stage diagnoses presentations among younger patients and the increased use of surgical therapies in the context of a growing practice. Understanding the impact of the COVID-19 pandemic on pediatric and adolescent cancer care can help us better adapt healthcare systems and interventions to the emerging needs of children and adolescents with cancer in the midst of a health crisis.


Asunto(s)
COVID-19 , Neoplasias , Adolescente , Humanos , Niño , Recién Nacido , Lactante , Preescolar , Adulto Joven , Adulto , COVID-19/epidemiología , Estudios Transversales , Pandemias , SARS-CoV-2 , Tanzanía/epidemiología , Neoplasias/diagnóstico , Neoplasias/epidemiología , Neoplasias/terapia
6.
J Transl Med ; 22(1): 106, 2024 01 26.
Artículo en Inglés | MEDLINE | ID: mdl-38279125

RESUMEN

Multi-omics approaches have been successfully applied to investigate pregnancy and health outcomes at a molecular and genetic level in several studies. As omics technologies advance, research areas are open to study further. Here we discuss overall trends and examples of successfully using omics technologies and techniques (e.g., genomics, proteomics, metabolomics, and metagenomics) to investigate the molecular epidemiology of pregnancy. In addition, we outline omics applications and study characteristics of pregnancy for understanding fundamental biology, causal health, and physiological relationships, risk and prediction modeling, diagnostics, and correlations.


Asunto(s)
Genómica , Proteómica , Humanos , Embarazo , Femenino , Epidemiología Molecular , Genómica/métodos , Proteómica/métodos , Metabolómica/métodos , Metagenómica
8.
PLOS Glob Public Health ; 4(1): e0002872, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38277421

RESUMEN

Over 1.7 billion children lack access to surgical care, mostly in low- and middle-income countries (LMICs), with substantial risks of catastrophic health expenditures (CHE) and impoverishment. Increasing interest in reducing out-of-pocket (OOP) expenditures as a tool to reduce the rate of poverty is growing. However, the impact of reducing OOP expenditures on CHE remains poorly understood. The purpose of this study was to estimate the global impact of reducing OOP expenditures for pediatric surgical care on the risk of CHE within and between countries. Our goal was to estimate the impact of reducing OOP expenditures for surgical care in children for 149 countries by modeling the risk of CHE under various scale-up scenarios using publicly available World Bank data. Scenarios included reducing OOP expenditures from baseline levels to paying 70%, 50%, 30%, and 10% of OOP expenditures. We also compared the impact of these reductions across income quintiles (poorest, poor, middle, rich, richest) and differences by country income level (low-income, lower-middle-income, upper-middle-income, and high-income countries).Reducing OOP expenditures benefited people from all countries and income quintiles, although the benefits were not equal. The risk of CHE due to a surgical procedure for children was highest in low-income countries. An unexpected observation was that upper-middle income countries were at higher risk for CHE than LMICs. The most vulnerable regions were Africa and Latin America. Across all countries, the poorest quintile had the greatest risk for CHE. Increasing interest in financial protection programs to reduce OOP expenditures is growing in many areas of global health. Reducing OOP expenditures benefited people from all countries and income quintiles, although the benefits were not equal across countries, wealth groups, or even by wealth groups within countries. Understanding these complexities is critical to develop appropriate policies to minimize the risks of poverty.

9.
Lancet Reg Health Am ; 29: 100651, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38124996

RESUMEN

Background: Snakebite envenoming (SBE) affects nearly three million people yearly, causing up to 180,000 deaths and 400,000 cases of permanent disability. Brazil's state of Amazonas is a global hotspot for SBE, with one of the highest annual incidence rates per 100,000 people, worldwide. Despite this burden, snake antivenom remains inaccessible to a large proportion of SBE victims in Amazonas. This study estimates the costs, and health and economic benefits of scaling up antivenom to community health centers (CHCs) and hospitals in the state. Methods: We built a decision tree model to simulate three different antivenom scale-up scenarios: (1) scale up to 95% of hospitals, (2) scale up to 95% of CHCs, and (3) scale up to 95% of hospitals and 95% of CHCs. We consider each scenario with and without a 10% increase in demand for antivenom among SBE victims. For each scenario, we model the treatment costs averted, deaths averted, and disability-adjusted life years (DALYs) averted from a societal, health system, and patient perspective relative to the status quo and over a time horizon of one year. For each scenario and perspective, we also calculate the incremental cost per DALY averted and per death averted. We use a willingness to pay threshold equal to the 2022 gross domestic product (GDP) per capita of Brazil. Findings: Scaling up antivenom to 95% of hospitals averts up to 2022 DALYs, costs up to USD $460 per DALY averted from a health system perspective, but results in net economic benefits up to USD $4.42 million from a societal perspective. Scaling up antivenom to 95% of CHCs averts up to 3179 DALYs, costs up to USD $308 per DALY averted from a health system perspective, but results in net economic benefits up to USD $7.35 million from a societal perspective. Scaling up antivenom to 95% of hospitals and CHCs averts up to 3922 DALYs, costs up to USD $328 per DALY averted from a health system perspective, but results in net economic benefits up to USD $8.98 million from a societal perspective. Interpretation: All three antivenom scale up scenarios - scale up to 95% of hospitals, scale up to 95% of CHCs, and scale up to 95% of hospitals and 95% of CHCs - avert a substantial proportion of the SBE burden in Amazonas and are cost-saving from a societal perspective and cost-effective from a health system perspective. Funding: W.M. and J.S. were funded by Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq productivity scholarships). W.M. was funded by Fundação de Amparo à Pesquisa do Estado do Amazonas (PRÓ-ESTADO, call n. 011/2021-PCGP/FAPEAM, call n. 010/2021-CT&I ÁREAS PRIORITÁRIAS, call n. 003/2022-PRODOC/FAPEAM, POSGRAD/FAPEAM) and by the Ministry of Health, Brazil (Proposal No. 733781/19-035). Research reported in this publication was supported by the Fogarty International Center of the National Institutes of Health under Award Number R21TW011944. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

10.
Matern Child Health J ; 28(5): 873-886, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38147276

RESUMEN

INTRODUCTION: An unprecedented shortage of infant formula occurred in the United States (U.S.) in 2022 and posed widespread challenges to infant feeding nationwide. The purpose of this study is to investigate mothers' experiences during the 2022 infant formula shortage and its perceived impacts on infants' diet and health. METHODS: Mothers (n = 45) of infants under 8 months old from Washington D.C. were invited to participate in a virtual study meeting during the summer of 2022. Mothers completed surveys regarding their demographics, infants' anthropometrics, infant feeding practices, information they have received about infant feeding, and knowledge about infant feeding practices. They then participated in a qualitative interview about their experiences during the infant formula shortage. RESULTS: Overarching themes were: the shortage (1) had adverse impacts on mothers' mental and emotional health; (2) had significant financial and intangible costs; (3) led to changes in infant feeding practices; (4) social and family networks were helpful in navigating the shortage; and (5) mothers felt fortunate to have resources to breastfeed and/or obtain formula. DISCUSSION: The infant formula shortage adversely impacted mothers' mental and emotional health, and was costly, in terms of financial and intangible costs. Findings demonstrate the need to develop clinical and policy approaches to support mothers in feeding their infants and provide education about safe infant feeding practices.


Asunto(s)
Fórmulas Infantiles , Madres , Lactante , Femenino , Humanos , Washingtón , Madres/psicología , Lactancia Materna/psicología , Conducta Alimentaria , Conocimientos, Actitudes y Práctica en Salud
11.
Vaccine ; 42(4): 972-986, 2024 Feb 06.
Artículo en Inglés | MEDLINE | ID: mdl-38135642

RESUMEN

Vaccine Benefit-Risk (B-R) assessment consists of evaluating the benefits and risks of a vaccine and making a judgment whether the expected key benefits outweigh the potential key risks associated with its expected use. B-R supports regulatory and public health decision-making throughout the vaccine's lifecycle. In August 2021, the Brighton Collaboration's Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Benefit-Risk Assessment Module working group was established to develop a standard module to support the planning, conduct and evaluation of structured B-R assessments for vaccines from different platforms, based on data from clinical trials, post-marketing studies and real-world evidence. It enables sharing of relevant information via value trees, effects tables and graphical depictions of B-R trade-offs. It is intended to support vaccine developers, funders, regulators and policy makers in high-, middle- or low-income countries to help inform decision-making and facilitate transparent communication concerning development, licensure, deployment and other lifecycle decisions.


Asunto(s)
Vacunas , Medición de Riesgo , Vacunas/efectos adversos , Humanos
12.
Gates Open Res ; 7: 50, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37868333

RESUMEN

Background: The Masimo Total Hemoglobin SpHb® is a continuous and non-invasive handheld device to measure hemoglobin levels. Previous research has found that SpHb is able to accurately detect hemoglobin levels in adult patients with a similar degree of bias and standard deviation to point-of-care invasive method measurements. Generally, limited clinical evidence, lack of validation of Masimo at higher than and lower than hemoglobin threshold values, and scientific consensus supporting the use of Masimo for accurate hemoglobin testing for the diagnosis of anemia during pregnancy calls for further research. Methods and analysis: The proposed prospective cohort will be nested within the ongoing Pregnancy Risk and Infant Surveillance and Measurement Alliance (PRISMA) Maternal and Newborn Health (MNH) study. Three study sites (located in Zambia, Kenya, and Pakistan) will participate and collect hemoglobin data at five time points (<20 weeks, 20 weeks, 28 weeks, 36 weeks' gestation, and six weeks postpartum). We will measure hemoglobin using a venous blood sample via hematology auto-analyzer complete blood count (gold standard) and the non-invasive device. The primary objective is to assess agreement between Masimo total hemoglobin and complete blood count and on a continuous scale using Intraclass Correlation Coefficient and Bland-Altman Analysis. The second objective is to assess agreement between the two measures on a binary scale using Positive Percentage Agreement and Negative Percentage Agreement, Cohen's Kappa, and McNemar Test. On an ordinal scale, agreement will be measured using Weighted Cohen's Kappa and Harrel's Concordance Index. Lastly, we will assess factors that might affect the accuracy of Masimo total hemoglobin using linear mixed models. Conclusions: The primary aim of this study is to assess the validity of the non-invasive Masimo device compared to the gold standard method of invasive hemoglobin measurements during pregnancy and postpartum periods for the diagnosis of anemia.


Asunto(s)
Anemia , Salud del Lactante , Adulto , Femenino , Humanos , Lactante , Recién Nacido , Embarazo , Recuento de Células Sanguíneas , Hemoglobinas/análisis , Estudios Prospectivos , Estudios Observacionales como Asunto
13.
Vaccine ; 41(45): 6762-6773, 2023 10 26.
Artículo en Inglés | MEDLINE | ID: mdl-37739888

RESUMEN

Novavax, a global vaccine company, began evaluating NVX-CoV2373 in human studies in May 2020 and the pivotal placebo-controlled phase 3 studies started in November 2020; five clinical studies provided adult and adolescent clinical data for over 31,000 participants who were administered NVX-CoV2373. This extensive data has demonstrated a well-tolerated response to NVX-CoV2373 and high vaccine efficacy against mild, moderate, or severe COVID-19 using a two-dose series (Dunkle et al., 2022) [1], (Heath et al., 2021) [2], (Keech et al., 2020) [3], (Mallory et al., 2022) [4]. The most common adverse events seen after administration with NVX-CoV2373 were injection site tenderness, injection site pain, fatigue, myalgia, headache, malaise, arthralgia, nausea, or vomiting. In addition, immunogenicity against variants of interest (VOI) and variants of concern (VOC) was established with high titers of ACE2 receptor-inhibiting and neutralizing antibodies in these studies (EMA, 2022) [5], (FDA, 2023) [6]. Further studies on correlates of protection determined that titers of anti-Spike IgG and neutralizing antibodies correlated with efficacy against symptomatic COVID-19 established in clinical trials (p < 0.001 for recombinant protein vaccine and p = 0.005 for mRNA vaccines for IgG levels) (Fong et al., 2022) [7]. Administration of a booster dose of the recombinant protein vaccine approximately 6 months following the primary two-dose series resulted in substantial increases in humoral antibodies against both the prototype strain and all evaluated variants, similar to or higher than the antibody levels observed in phase 3 studies that were associated with high vaccine efficacy (Dunkle et al., 2022) [1], (Mallory et al., 2022) [4]. These findings, together with the well tolerated safety profile, support use of the recombinant protein vaccine as primary series and booster regimens.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Adolescente , Adulto , Humanos , Vacunas contra la COVID-19/efectos adversos , SARS-CoV-2 , Glicoproteína de la Espiga del Coronavirus/genética , COVID-19/prevención & control , Adyuvantes Inmunológicos , Vacunas Sintéticas/efectos adversos , Vacunas Sintéticas/genética , Anticuerpos Neutralizantes , Medición de Riesgo , Inmunoglobulina G , Anticuerpos Antivirales , Inmunogenicidad Vacunal
14.
PLOS Glob Public Health ; 3(8): e0002177, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37527230

RESUMEN

Prior research has demonstrated an association between lead exposure and criminal behavior at the population-level, however studies exploring the effect of lead exposure on criminal behavior at the individual-level have not been reviewed systematically. The intent of this study is to complete a systematic review of all studies assessing individual-level exposures to lead and the outcomes of crime and antisocial behavior traits. We included peer reviewed studies that were published prior to August 2022 and were classified as cohort, cross-sectional, or case-control. Studies measuring the outcomes of crime, delinquency, violence, or aggression were included. The following databases were searched using a standardized search strategy: ProQuest Environmental Science Database, PubMed, ToxNet and the Public Affairs Information Service (PAIS). Seventeen manuscripts met our inclusion criteria. Blood lead was measured in 12 studies, bone lead in 3 studies, and dentine lead levels in 2 studies. This systematic review identified a wide range of diverse outcomes between exposure to lead at multiple windows of development and later delinquent, criminal and antisocial behavior. A review of all potential confounding variables included within each study was made, with inclusion of relevant confounders into the risk of bias tool. There is limited data at the individual level on the effects of prenatal, childhood, and adolescent lead exposure and later criminal behavior and more evidence is necessary to evaluate the magnitude of the associations seen in this review. Our review, in conjunction with the available biological evidence, suggests that an excess risk for criminal behavior in adulthood exists when an individual is exposed to lead in utero or in the early years of childhood. The authors report no conflict of interest and no funding source. Clinical trial registration: PROSPERO ID: CRD42021268379.

15.
Vaccine ; 41(35): 5159-5181, 2023 08 07.
Artículo en Inglés | MEDLINE | ID: mdl-37442686

RESUMEN

BACKGROUND: Existing ethics guidance and regulatory requirements emphasize the need for pregnancy-specific safety and efficacy data during the development of vaccines in health emergencies. Our objective was to conduct a systematic review of vaccine clinical trials during active epidemic periods. METHODS: We searched for Phase II and Phase III vaccine clinical trials initiated during the H1N1 influenza, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Zika, and Ebola virus disease (EVD) outbreaks from 2009 to 2019. Data were extracted from clinical trial protocols identified in the following registries: ClinicalTrials.gov, Pan African Clinical Trial Registry (PACTR), and all primary registries indicated by the World Health Organization's International Clinical Trials Registry Platform (ICTRP). Published studies from registered clinical trials were located through PubMed. Data was extracted on eligibility criteria and pregnancy outcomes. Data from this study is available in the Center for Open Science Data Repository: https://osf.io/nfk2p/?view_only=47deb3b206724af9b46c9c0c0083a267. RESULTS: We identified 96 vaccine clinical trial protocols and included 84 in analysis. 5 records were excluded in screening for irrelevant abstracts, 7 were excluded in full-text assessment (1 for a therapeutic drug trial, 3 for enrolling elderly adults only, 3 for enrolling children/adolescents only). There were no eligible trials for MERS-CoV or Zika virus vaccines. Overall, 8 protocols explicitly included pregnant people; of these, 3 were completed trials with published results. Incidental pregnancies and outcomes of pregnant participants were reported in 2 studies, 10 studies reported serious adverse events related to pregnancy without mentioning total incidental pregnancies. A total of 411 recorded pregnancy outcomes were reported, with 293 from the 3 pregnancy-eligible studies with results. 71 serious adverse events pertaining to pregnancy were reported from all clinical trials with results. CONCLUSION: Pregnant people are underrepresented in vaccine clinical trials conducted during outbreaks, resulting in underreporting of pregnancy-related outcomes and a lack of protection for pregnant people and neonates from infectious diseases.


Asunto(s)
Subtipo H1N1 del Virus de la Influenza A , Gripe Humana , Coronavirus del Síndrome Respiratorio de Oriente Medio , Vacunas , Infección por el Virus Zika , Virus Zika , Adolescente , Adulto , Anciano , Niño , Femenino , Humanos , Recién Nacido , Embarazo , Brotes de Enfermedades , Gripe Humana/prevención & control , Infección por el Virus Zika/prevención & control , Protocolos de Ensayos Clínicos como Asunto
16.
PLOS Glob Public Health ; 3(7): e0000713, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37450441

RESUMEN

There is very limited data on the extent and determinants of COVID-19 vaccine hesitancy among adults living in sub-Saharan Africa since the global roll-out of vaccines began in 2021. This multi-country survey sought to investigate COVID-19 vaccine hesitancy and other predictors of readiness to get vaccinated. We conducted surveys among adults residing in nine urban and rural areas in Burkina Faso, Ethiopia, Ghana, Nigeria, and Tanzania in late 2021. Log binomial regression models were used to identify prevalence and factors associated with vaccine hesitancy and beliefs around COVID-19 misinformation. We completed a total of 2,833 interviews. Among all respondents, 9% had never heard of a COVID-19 vaccine, 12% had been vaccinated, and 20% knew someone else who had been vaccinated. The prevalence of vaccine hesitancy varied by country (Ethiopia 29%, Burkina Faso 33%, Nigeria 34%, Ghana 42%, Tanzania 65%), but not by rural or urban context. People who did not think the vaccine was safe or effective, or who were unsure about it, were more likely to be vaccine hesitant. Those who reported they did not have a trusted source of information about the vaccine (aPR: 1.25, 95% CI: 1.18,1.31) and those who thought the vaccine would not be made available to them within the year were more likely to be vaccine hesitant. Women were more likely to be vaccine hesitant (aPR: 1.31, 95% CI: 1.19,1.43) and believe COVID-19 falsehoods (aPR: 1.05, 95% CI: 1.02,1.08). The most commonly believed falsehoods were that the vaccine was developed too fast and that there was not enough information about whether the vaccine was effective or not. Educational campaigns targeted at misinformation and tailored to suit each country are recommended to build trust in COVID-19 vaccines and reduce hesitancy.

17.
PLOS Glob Public Health ; 3(7): e0002084, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37523346

RESUMEN

Improving access to surgical care in India requires policy-level prioritization of surgical, obstetric, trauma, and anesthesia (SOTA) care. We quantified SOTA care prioritization in the last seven decades by analyzing India's national policy and programmatic documents. Forty documents of national importance over seven decades (1946-2017) were screened for a set of 52 surgical and 6 non-surgical keywords. The number of mentions per keyword was used as a proxy for surgical prioritization. For thematic analysis, surgical mentions were further classified into five domains: Infrastructure, Workforce, Service Delivery, Financing, and Information Management. The total number of mentions was 4681 for the surgical keywords and 2322 for non-surgical. The number of mentions per keyword was 90.02 for surgical keywords and 387 for non-surgical. The older committee reports showed relatively higher SOTA care prioritization compared to the years after 2010. Among the domains, Service Delivery (897) had the maximum number of mentions followed by Infrastructure (545), Workforce (516), Financing (98), and Information Management (40). National Health Policy 2017, the most recent high-level policy, grossly neglected SOTA care. SOTA care is inadequately prioritized in Indian national health policies, especially in the documents after 2010. Concerted efforts are necessary to improve the focus on financing and information management. Prioritization can be improved through a stand-alone national plan for SOTA care along with integration into existing policies.

18.
Lancet Reg Health Southeast Asia ; 13: 100178, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37383563

RESUMEN

For universal surgical, obstetric, trauma, and anesthesia care by 2030, the Lancet Commission on Global Surgery (LCoGS) suggested tracking six indicators. We reviewed academic and policy literature to investigate the current state of LCoGS indicators in India. There was limited primary data for access to timely essential surgery, risk of impoverishing and catastrophic health expenditures due to surgery, though some modeled estimates are present. Surgical specialist workforce estimates are heterogeneous across different levels of care, urban and rural areas, and diverse health sectors. Surgical volumes differ widely across demographic, socio-economic, and geographic cohorts. Perioperative mortality rates vary across procedures, diagnoses, and follow-up time periods. Available data suggest India falls short of achieving global targets. This review highlights the evidence gap for India's surgical care planning. India needs a systematic subnational mapping of indicators and adaptation of targets as per the country's health needs for equitable and sustainable planning.

19.
JCO Glob Oncol ; 9: e2200263, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37384861

RESUMEN

PURPOSE: Over 400,000 children are diagnosed with cancer around the world each year, with over 80% of these children residing in low- and middle-income countries. This study aims to summarize the epidemiology and care patterns of newly diagnosed childhood cancer patients in Northern Tanzania. METHODS: Data from all children and adolescents (age 0-19 years) with newly diagnosed cancers were collected from the Kilimanjaro Cancer Registry located at the Kilimanjaro Christian Medical Centre. Descriptive and inferential analyses were used to compare the demographic and clinical characteristics of the participants over time, stage, and status at last contact. Statistical significance was set at P < .05. Secondary descriptive analysis was conducted on a subset sample with available staging data. RESULTS: A total of 417 patients were diagnosed with cancer between 2016 and 2021. There was an increase in the rate of patients with newly diagnosed pediatric cancer each year, particularly among children under age 5 years and 10 years. Leukemias and lymphomas were the leading diagnoses and accounted for 183 (43.8%) of all patients. Over 75% of patients were diagnosed at stage III or above. From a subset analysis of patients with available staging data (n = 101), chemotherapy was the most common treatment (87.1%), compared with radiotherapy and surgery. CONCLUSION: There is a significant burden of children with cancer in Tanzania. Our study fills crucial gaps in the literature related to the large burden of disease and survival for children with cancer in the Kilimanjaro region. Furthermore, our results can be used to understand the regional needs and guide research and strategic interventions to improve childhood cancer survival in Northern Tanzania.


Asunto(s)
Neoplasias , Oncología por Radiación , Niño , Humanos , Adolescente , Recién Nacido , Lactante , Preescolar , Adulto Joven , Adulto , Estudios Retrospectivos , Centros de Atención Terciaria , Tanzanía/epidemiología , Neoplasias/diagnóstico , Neoplasias/epidemiología , Neoplasias/terapia
20.
BMJ Open ; 13(5): e069572, 2023 05 02.
Artículo en Inglés | MEDLINE | ID: mdl-37130683

RESUMEN

OBJECTIVES: An estimated 1.7 billion children around the world do not have access to safe, affordable and timely surgical care, with the financing through out-of-pocket (OOP) expenses being one of the main barriers to care. Our study modelled the impact of reducing OOP costs related to surgical care for children in Somaliland on the risk of catastrophic expenditures and impoverishment. DESIGN AND SETTING: This cross-sectional nationwide economic evaluation modelled several different approaches to reduction of paediatric OOP surgical costs in Somaliland. PARTICIPANTS AND OUTCOME MEASURES: A surgical record review of all procedures on children up to 15 years old was conducted at 15 surgically capable hospitals. We modelled two rates of OOP cost reduction (reduction of OOP proportion from 70% to 50% and from 70% to 30% reduction in OOP costs) across five wealth quintiles (poorest, poor, neutral, rich, richest) and two geographical areas (urban and rural). The outcome measures of the study are catastrophic expenditures and risk of impoverishment due to surgery. We followed the Consolidated Health Economic Evaluation Reporting Standards. RESULTS: We found that the risk of catastrophic and impoverishing expenditures related to OOP expenditures for paediatric surgery is high across Somaliland, but most notable in the rural areas and among the poorest quintiles. Reducing OOP expenses for surgical care to 30% would protect families in the richest wealth quintiles while minimally affecting the risk of catastrophic expenditure and impoverishment for those in the lowest wealth quintiles, particularly those in rural areas. CONCLUSION: Our models suggest that the poorest communities in Somaliland lack protection against the risk of catastrophic health expenditure and impoverishment, even if OOP payments are reduced to 30% of surgical costs. A comprehensive financial protection in addition to reduction of OOP costs is required to prevent risk of impoverishment in these communities.


Asunto(s)
Composición Familiar , Gastos en Salud , Humanos , Niño , Análisis Costo-Beneficio , Estudios Transversales , Pobreza
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