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BackgroundApproximately 90% of currently published clinical and public health research is in the form of observational studies. Having a detailed and registered study protocol prior to data collection is important in any empirical study. Without this, there is no reliable way to assess the occurrence of publication bias, outcome reporting bias, and other protocol deviations. However, there is currently no solid guidance available on the information that a protocol for an observational study should contain. ObjectiveThe aim of this study is to formulate the Standardized Protocol Items Recommendations for Observational Studies (SPIROS) reporting guidelines, which focus on 3 main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies. MethodsA scoping review of published protocol papers of observational studies in epidemiology will identify candidate items for the SPIROS reporting guidelines. The list of items will be extended with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist items and recommendations from the SPIROS steering committee. This long list serves as the basis for a 2-round Delphi survey among experts to obtain consensus on which items to include. Each candidate item from the long list will be rated on a 5-point Likert scale to assess relevance for inclusion in the SPIROS reporting guidelines. Following the Delphi survey, an expert-driven consensus workshop will be convened to finalize the reporting guidelines. ResultsA scoping review of published observational study protocols has been completed, with 59 candidate items identified for inclusion into the Delphi survey, itself launched in early 2020. ConclusionsThis project aims to improve the timeliness, completeness, and clarity of study protocols of observational studies in analytical epidemiology by producing expert-based recommendations of items to be addressed. These reporting guidelines will facilitate and encourage researchers to prepare and register study protocols of sufficient quality prior to data collection in order to improve the transparency, reproducibility, and quality of observational studies. International Registered Report Identifier (IRRID)PRR1-10.2196/17864

Background More than half of childhood tuberculosis cases remain undiagnosed yearly. The World Health Organization recommends the Xpert-Ultra assay as a first pediatric diagnosis test, but microbiological confirmation remains low. We aimed to determine the diagnostic performance of Xpert-Ultra with stool and urine samples in presumptive pediatric tuberculosis cases in 2 high-tuberculosis-burden settings. Methods This Médecins Sans Frontières cross-sectional multicentric study took place at Simão Mendes Hospital, Guinea-Bissau (July 2019 to April 2020) and in Malakal Hospital, South Sudan (April 2021 to June 2023). Children aged 6 months to 15 years with presumptive tuberculosis underwent clinical and laboratory assessment, with 1 respiratory and/or extrapulmonary sample (reference standard [RS]), 1 stool, and 1 urine specimen analyzed with Xpert-Ultra. Results A total of 563 children were enrolled in the study, 133 from Bissau and 400 from Malakal; 30 were excluded. Confirmation of tuberculosis was achieved in 75 (14.1%), while 248 (46.5%) had unconfirmed tuberculosis. Of 553 with an RS specimen, the overall diagnostic yield was 12.4% (66 of 533). A total of 493 stool and 524 urine samples were used to evaluate the performance of Xpert-Ultra with these samples. Compared with the RS, the sensitivity and specificity of Xpert-Ultra were 62.5% (95% confidence interval, 49.4%–74%) and 98.3% (96.7%–99.2%), respectively, with stool samples, and 13.9% (7.5%–24.3%) and 99.4% (98.1%–99.8%) with urine samples. Nine patients were positive with stool and/or urine samples but negative with the RS. Conclusions Xpert-Ultra in stool samples showed moderate to high sensitivity and high specificity compared with the RS and an added diagnostic yield when RS results were negative. Xpert-Ultra in stool samples was useful in extrapulmonary cases. Xpert-Ultra in urine samples showed low test performance. Clinical Trials Registration NCT06239337 [ABSTRACT FROM AUTHOR]

Efficient resource allocation is essential for effective pandemic response. We measured host biomarkers in 420 patients presenting with moderate coronavirus disease 2019 and found that different biomarkers predict distinct clinical outcomes. Interleukin (IL)–1ra, IL-6, IL-10, and IL-8 exhibit dose-response relationships with subsequent disease progression and could potentially be useful for multiple use-cases. [ABSTRACT FROM AUTHOR]

Background. Reports on treatment outcomes of visceral leishmaniasis (VL)-human immunodeficiency virus (HIV) coinfection in India are lacking. To our knowledge, none have studied the efficacy of liposomal amphotericin B in VL-HIV coinfection. We report the 2-year treatment outcomes of VL-HIV-coinfected patients treated with liposomal amphotericin B followed by combination antiretroviral treatment (cART) in Bihar, India. Methods. The study included all patients with newly diagnosed VL-HIV coinfection and initiating treatment with liposomal amphotericin B (20-25 mg/kg in 4-15 days) between July 2007 and September 2010. Kaplan-Meier estimates of the cumulative incidence of death/treatment failure were calculated. Results. Fifty-five patients were included (83.6% male; median age, 35 years; 62% migrant laborers; median follow-up, 1 year). The median CD4 cell count at VL diagnosis was 66 cells/μL (interquartile range, 38-112). Twentyseven patients (49.1%) presented with VL relapse of VL. The overall tolerance of liposomal amphotericin B was excellent, with no interrupted treatment. Survival by 1 and 2 years after VL treatment was estimated at 85.5%. Nopatients had initial treatment failure. The probabilities of VL relapse were 0%, 8.1%, and 26.5% at 0.5, 1, and 2 years after VL treatment, respectively; relapse rates were similar for primary VL and VL relapse. CD4 counts<200 cells/μL at 6 months after cART initiation were predictive of subsequent relapse. The mean CD4 cell counts at 6 and 24 months after cART initiation were 187 and 261 cells/μL, respectively. The rate for retention in HIV care was 83.6%. Conclusions. Good long-term survival and retention rates were obtained for VL-HIV-coinfected patients treated with liposomal amphotericin B and cART. Although the initial VL treatment response was excellent, VL relapse within 2 years remained frequent. [ABSTRACT FROM AUTHOR]

The article presents a more nuanced understanding of the epidemiology of undernutrition in India and relevant programmatic issues. It notes that malnourished children in India are managed at the village level by Anganwadi workers through village child development centers located at Anganwadi centers (AWCs) of the Integrated Child Development Services (ICDS) while facility-based management of severe undernutrition is through nutritional rehabilitation centers (NRCs).

The dual burden of human immunodeficiency virus (HIV) and tuberculosis (TB) impacts people living with HIV (PLHIV) coinfected with TB. Although some primary studies have been reported on the burden of extrapulmonary TB (EPTB) among PLHIV in Southeast Asia (SEA), there is no systematic review or meta-analysis that attempts to summarize the available literature. Therefore, this review aims to summarize the prevalence of EPTB/HIV co-infection in SEA using meta-analysis based on a systematic review of published articles and gray literature. A comprehensive 3-stage methodology was adopted to conduct a thorough literature search, encompassing both published and gray literature. Data sources such as MEDLINE and Web of Science were searched for articles reporting data from SEA between 2010 and 2022. Findings were reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines and were sourced using a predefined search strategy from different databases. The Joanna Briggs Institute prevalence studies checklist was employed for critical appraisal. The meta-analysis of proportions was carried out using the "metaprop" function in R software (version 4.3.1) to generate pooled estimates. Effects were summarized using random-effects models, and sources of heterogeneity were explored through I2, utilizing subgroup and sensitivity analyses. Publication bias was assessed using funnel plots and pertinent statistical tests, including Egger's regression analysis. A total of 474 studies were initially identified in our search. After the removal of duplicates and a meticulous screening process of titles and abstracts, along with the application of exclusion criteria, 22 studies comprising 34,740 PLHIV were included in the final meta-analysis. The summary effect or pooled proportion estimate of EPTB among PLHIV was found to be 18% [95% confidence interval (CI): 15,22; heterogeneity: τ2=0.0056; degrees of freedom=21, p<0.001; I2=99%]. Our study showed that there was a diverse range of prevalence of EPTB among PLHIV in the SEA region, which ranged from 5% (95% CI: 4.0-7.0) in South Korea to 48% (95% CI: 41.0-55.0) in Thailand. Our systematic review and meta-analysis indicate a notably higher prevalence of EPTB among PLHIV. Early diagnosis of EPTB is crucial to mitigating associated morbidity and mortality. Therefore, a thorough medical history and comprehensive physical examination are imperative in assessing PLHIV, aiming to promptly identify and rule out EPTB. After a diligent evaluation, appropriate diagnostic measures and tailored management strategies should be promptly instituted.