Last data update: Apr 22, 2024. (Total: 46599 publications since 2009)
Records 1-30 (of 259 Records) |
Query Trace: Sharma R [original query] |
---|
Overview of U.S. COVID-19 vaccine safety surveillance systems
Gee J , Shimabukuro TT , Su JR , Shay D , Ryan M , Basavaraju SV , Broder KR , Clark M , Buddy Creech C , Cunningham F , Goddard K , Guy H , Edwards KM , Forshee R , Hamburger T , Hause AM , Klein NP , Kracalik I , Lamer C , Loran DA , McNeil MM , Montgomery J , Moro P , Myers TR , Olson C , Oster ME , Sharma AJ , Schupbach R , Weintraub E , Whitehead B , Anderson S . Vaccine 2024 The U.S. COVID-19 vaccination program, which commenced in December 2020, has been instrumental in preventing morbidity and mortality from COVID-19 disease. Safety monitoring has been an essential component of the program. The federal government undertook a comprehensive and coordinated approach to implement complementary safety monitoring systems and to communicate findings in a timely and transparent way to healthcare providers, policymakers, and the public. Monitoring involved both well-established and newly developed systems that relied on both spontaneous (passive) and active surveillance methods. Clinical consultation for individual cases of adverse events following vaccination was performed, and monitoring of special populations, such as pregnant persons, was conducted. This report describes the U.S. government's COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccination. Finally, the process for timely and transparent communication and dissemination of COVID-19 vaccine safety data is described, highlighting the responsiveness and robustness of the U.S. vaccine safety monitoring infrastructure during the national COVID-19 vaccination program. |
A chemo-mechanical model for describing sorption hysteresis in a glassy polyurethane
Foley BL , Matt SM , Castonguay ST , Sun Y , Roy P , Glascoe EA , Sharma HN . Sci Rep 2024 14 (1) 5640 Hysteretic sorption and desorption of water is observed from 0 to 95% relative humidity and 298-333 K on a glassy polyurethane foam. It is postulated that sorption-induced swelling of the glassy polyurethane increases the concentration of accessible hydrogen-bonding adsorption sites for water. The accessibility of sites is kinetically controlled due to the restricted thermal motions of chains in the glassy polymer, causing a difference in accessible site concentrations during sorption and desorption. This discrepancy leads to hysteresis in the sorbed concentrations of water. A coupled chemo-mechanical model relating volumetric strain, adsorption site concentration, and sorbed water concentration is employed to describe water sorption hysteresis in the glassy polyurethane. This model not only describes the final mass uptake for each relative humidity step, but also captures the dynamics of water uptake, which exhibit diffusion and relaxation rate-controlled regimes. |
Expansion of Neisseria meningitidis serogroup C clonal complex 10217 during meningitis outbreak, Burkina Faso, 2019
Kekeisen-Chen JF , Tarbangdo FT , Sharma S , Marasini D , Marjuki H , Kibler JL , Reese HE , Ouattara S , Ake FH , Yameogo I , Ouedraogo I , Seini E , Zoma RL , Tonde I , Sanou M , Novak RT , McNamara LA . Emerg Infect Dis 2024 30 (3) 460-468 During January 28-May 5, 2019, a meningitis outbreak caused by Neisseria meningitidis serogroup C (NmC) occurred in Burkina Faso. Demographic and laboratory data for meningitis cases were collected through national case-based surveillance. Cerebrospinal fluid was collected and tested by culture and real-time PCR. Among 301 suspected cases reported in 6 districts, N. meningitidis was the primary pathogen detected; 103 cases were serogroup C and 13 were serogroup X. Whole-genome sequencing revealed that 18 cerebrospinal fluid specimens tested positive for NmC sequence type (ST) 10217 within clonal complex 10217, an ST responsible for large epidemics in Niger and Nigeria. Expansion of NmC ST10217 into Burkina Faso, continued NmC outbreaks in the meningitis belt of Africa since 2019, and ongoing circulation of N. meningitidis serogroup X in the region underscore the urgent need to use multivalent conjugate vaccines in regional mass vaccination campaigns to reduce further spread of those serogroups. |
Selection of antibiotics as prophylaxis for close contacts of patients with meningococcal disease in areas with ciprofloxacin resistance - United States, 2024
Berry I , Rubis AB , Howie RL , Sharma S , Marasini D , Marjuki H , Crowe S , McNamara LA . MMWR Morb Mortal Wkly Rep 2024 73 (5) 99-103 Meningococcal disease, caused by the bacterium Neisseria meningitidis, is a rare but life-threatening illness that requires prompt antibiotic treatment for patients and antibiotic prophylaxis for their close contacts. Historically, N. meningitidis isolates in the United States have been largely susceptible to the antibiotics recommended for prophylaxis, including ciprofloxacin. Since 2019, however, the number of meningococcal disease cases caused by ciprofloxacin-resistant strains has increased. Antibiotic prophylaxis with ciprofloxacin in areas with ciprofloxacin resistance might result in prophylaxis failure. Health departments should preferentially consider using antibiotics other than ciprofloxacin as prophylaxis for close contacts when both of the following criteria have been met in a local catchment area during a rolling 12-month period: 1) the reporting of two or more invasive meningococcal disease cases caused by ciprofloxacin-resistant strains, and 2) ≥20% of all reported invasive meningococcal disease cases are caused by ciprofloxacin-resistant strains. Other than ciprofloxacin, alternative recommended antibiotic options include rifampin, ceftriaxone, or azithromycin. Ongoing monitoring for antibiotic resistance of meningococcal isolates through surveillance and health care providers' reporting of prophylaxis failures will guide future updates to prophylaxis considerations and recommendations. |
Tropical data: Approach and methodology as applied to trachoma prevalence surveys
Harding-Esch EM , Burgert-Brucker CR , Jimenez C , Bakhtiari A , Willis R , Bejiga MD , Mpyet C , Ngondi J , Boyd S , Abdala M , Abdou A , Adamu Y , Alemayehu A , Alemayehu W , Al-Khatib T , Apadinuwe SC , Awaca N , Awoussi MS , Baayendag G , Badiane MD , Bailey RL , Batcho W , Bay Z , Bella A , Beido N , Bol YY , Bougouma C , Brady CJ , Bucumi V , Butcher R , Cakacaka R , Cama A , Camara M , Cassama E , Chaora SG , Chebbi AC , Chisambi AB , Chu B , Conteh A , Coulibaly SM , Courtright P , Dalmar A , Dat TM , Davids T , Djaker MEA , de Fátima Costa Lopes M , Dézoumbé D , Dodson S , Downs P , Eckman S , Elshafie BE , Elmezoghi M , Elvis AA , Emerson P , Epée EE , Faktaufon D , Fall M , Fassinou A , Fleming F , Flueckiger R , Gamael KK , Garae M , Garap J , Gass K , Gebru G , Gichangi MM , Giorgi E , Goépogui A , Gómez DVF , Gómez Forero DP , Gower EW , Harte A , Henry R , Honorio-Morales HA , Ilako DR , Issifou AAB , Jones E , Kabona G , Kabore M , Kadri B , Kalua K , Kanyi SK , Kebede S , Kebede F , Keenan JD , Kello AB , Khan AA , Khelifi H , Kilangalanga J , Kim SH , Ko R , Lewallen S , Lietman T , Logora MSY , Lopez YA , MacArthur C , Macleod C , Makangila F , Mariko B , Martin DL , Masika M , Massae P , Massangaie M , Matendechero HS , Mathewos T , McCullagh S , Meite A , Mendes EP , Abdi HM , Miller H , Minnih A , Mishra SK , Molefi T , Mosher A , M'Po N , Mugume F , Mukwiza R , Mwale C , Mwatha S , Mwingira U , Nash SD , Nassa C , Negussu N , Nieba C , Noah Noah JC , Nwosu CO , Olobio N , Opon R , Pavluck A , Phiri I , Rainima-Qaniuci M , Renneker KK , Saboyá-Díaz MI , Sakho F , Sanha S , Sarah V , Sarr B , Szwarcwald CL , Shah Salam A , Sharma S , Seife F , Serrano Chavez GM , Sissoko M , Sitoe HM , Sokana O , Tadesse F , Taleo F , Talero SL , Tarfani Y , Tefera A , Tekeraoi R , Tesfazion A , Traina A , Traoré L , Trujillo-Trujillo J , Tukahebwa EM , Vashist P , Wanyama EB , Warusavithana SDP , Watitu TK , West S , Win Y , Woods G , Yajima A , Yaya G , Zecarias A , Zewengiel S , Zoumanigui A , Hooper PJ , Millar T , Rotondo L , Solomon AW . Ophthalmic Epidemiol 2023 30 (6) 544-560 PURPOSE: Population-based prevalence surveys are essential for decision-making on interventions to achieve trachoma elimination as a public health problem. This paper outlines the methodologies of Tropical Data, which supports work to undertake those surveys. METHODS: Tropical Data is a consortium of partners that supports health ministries worldwide to conduct globally standardised prevalence surveys that conform to World Health Organization recommendations. Founding principles are health ministry ownership, partnership and collaboration, and quality assurance and quality control at every step of the survey process. Support covers survey planning, survey design, training, electronic data collection and fieldwork, and data management, analysis and dissemination. Methods are adapted to meet local context and needs. Customisations, operational research and integration of other diseases into routine trachoma surveys have also been supported. RESULTS: Between 29(th) February 2016 and 24(th) April 2023, 3373 trachoma surveys across 50 countries have been supported, resulting in 10,818,502 people being examined for trachoma. CONCLUSION: This health ministry-led, standardised approach, with support from the start to the end of the survey process, has helped all trachoma elimination stakeholders to know where interventions are needed, where interventions can be stopped, and when elimination as a public health problem has been achieved. Flexibility to meet specific country contexts, adaptation to changes in global guidance and adjustments in response to user feedback have facilitated innovation in evidence-based methodologies, and supported health ministries to strive for global disease control targets. |
CDC COVID-19 Vaccine Pregnancy Registry: Design, data collection, response rates, and cohort description
Madni SA , Sharma AJ , Zauche LH , Waters AV , Nahabedian JF 3rd , Johnson T , Olson CK . Vaccine 2023 The U.S. Centers for Disease Control and Prevention (CDC) developed and implemented the CDC COVID-19 Vaccine Pregnancy Registry (C19VPR) to monitor vaccine safety. Potential participants who received a COVID-19 vaccine in pregnancy or up to 30 days prior to their pregnancy-associated last menstrual period were eligible to participate in the registry, which monitored health outcomes of participants and their infants through phone interviews and review of available medical records. Data for select outcomes, including birth defects, were reviewed by clinicians. In certain cases, medical records were used to confirm and add detail to participant-reported health conditions. This paper serves as a description of CDC C19VPR protocol. We describe the development and implementation for each data collection aspect of the registry (i.e., participant phone interviews, clinical review, and medical record abstraction), data management, and strengths and limitations. We also describe the demographics and vaccinations received among eligible and enrolled participants. There were 123,609 potential participants 18-54 years of age identified from January 2021 through mid-June 2021; 23,339 were eligible and enrolled into the registry. Among these, 85.3 % consented to medical record review for themselves and/or their infants. Participants were majority non-Hispanic White (79.1 %), residents of urban areas (93.3 %), and 48.3 % were between 30 and 34 years of age. Most participants completed the primary series of vaccination by the end of pregnancy (89.7 %). Many participants were healthcare personnel (44.8 %), possibly due to the phased roll-out of the vaccination program. The registry continues to provide important information about the safety of COVID-19 vaccination among pregnant people, a population with higher risk of poor outcomes from COVID-19 who were not included in pre-authorization clinical trials. Lessons learned from the registry may guide development and implementation of future vaccine safety monitoring efforts for pregnant people and their infants. |
Range of the perfluorooctanoate (PFOA) safe dose for human health: An international collaboration
Burgoon LD , Clewell HJ , Cox T , Dekant W , Dell LD , Deyo JA , Dourson ML , Gadagbui BK , Goodrum P , Green LC , Vijayavel K , Kline TR , House-Knight T , Luster MI , Manning T , Nathanail P , Pagone F , Richardson K , Severo-Peixe T , Sharma A , Smith JS , Verma N , Wright J . Regul Toxicol Pharmacol 2023 145 Many government agencies and expert groups have estimated a dose-rate of perfluorooctanoate (PFOA) that would protect human health. Most of these evaluations are based on the same studies (whether of humans, laboratory animals, or both), and all note various uncertainties in our existing knowledge. Nonetheless, the values of these various, estimated, safe-doses vary widely, with some being more than 100,000 fold different. This sort of discrepancy invites scrutiny and explanation. Otherwise what is the lay public to make of this disparity? The Steering Committee of the Alliance for Risk Assessment (2022) called for scientists interested in attempting to understand and narrow these disparities. An advisory committee of nine scientists from four countries was selected from nominations received, and a subsequent invitation to scientists internationally led to the formation of three technical teams (for a total of 24 scientists from 8 countries). The teams reviewed relevant information and independently developed ranges for estimated PFOA safe doses. All three teams determined that the available epidemiologic information could not form a reliable basis for a PFOA safe dose-assessment in the absence of mechanistic data that are relevant for humans at serum concentrations seen in the general population. Based instead on dose-response data from five studies of PFOA-exposed laboratory animals, we estimated that PFOA dose-rates 10–70 ng/kg-day are protective of human health. © 2023 Elsevier Inc. |
Persistence of immunity following a single dose of inactivated poliovirus vaccine: a phase 4, open label, non-randomised clinical trial
Sharma AK , Verma H , Estivariz CF , Bajracharaya L , Rai G , Shah G , Sherchand J , Jones KAV , Mainou BA , Chavan S , Jeyaseelan V , Sutter RW , Shrestha LP . Lancet Microbe 2023 4 (11) e923-e930 BACKGROUND: The polio eradication endgame required the withdrawal of Sabin type 2 from the oral poliovirus vaccine and introduction of one or more dose of inactivated poliovirus vaccine (IPV) into routine immunisation schedules. However, the duration of single-dose IPV immunity is unknown. We aimed to address this deficiency. METHODS: In this phase 4, open-label, non-randomised clinical trial, we assessed single-dose IPV immunity. Two groups of infants or children were screened: the first group had previously received IPV at 14 weeks of age or older (previous IPV group; age >2 years); the second had not previously received IPV (no previous IPV group; age 7-12 months). At enrolment, all participants received an IPV dose. Children in the no previous IPV group received a second IPV dose at day 30. Blood was collected three times in each group: on days 0, 7, and 30 in the previous IPV group and on days 0, 30, and 37 in the no previous IPV group. Poliovirus antibody was measured by microneutralisation assay. Immunity was defined as the presence of a detectable antibody or a rapid anamnestic response (ie, priming). We used the χ(2) to compare proportions and the Mann-Whitney U test to assess continuous variables. To assess safety, vaccinees were observed for 30 min, caregivers for each participating child reported adverse events after each follow-up visit and were questioned during each follow-up visit regarding any adverse events during the intervening period. Adverse events were recorded and graded according to the severity of clinical symptoms. The study is registered with ClinicalTrials.gov, NCT03723837. FINDINGS: From Nov 18, 2018, to July 31, 2019, 502 participants enrolled in the study, 458 (255 [65%] boys and 203 [44%] girls) were included in the per protocol analysis: 234 (93%) in the previous IPV group and 224 (90%) in the no previous IPV group. In the previous IPV group, 28 months after one IPV dose 233 (>99%) of 234 children had persistence of poliovirus type 2 immunity (100 [43%] of 234 children were seropositive; 133 [99%] of 134 were seronegative and primed). In the no previous IPV group, 30 days after one IPV dose all 224 (100%) children who were type 2 poliovirus naive had seroconverted (223 [>99%] children) or were primed (one [<1%]). No adverse events were deemed attributable to study interventions. INTERPRETATION: A single IPV dose administered at 14 weeks of age or older is highly immunogenic and induces nearly universal type 2 immunity (seroconversion and priming), with immunity persisting for at least 28 months. The polio eradication initiative should prioritise first IPV dose administration to mitigate the paralytic burden caused by poliovirus type 2. FUNDING: WHO and Rotary International. |
Adjunctive diagnostic studies completed following detection of candidemia in children: Secondary analysis of observed practice from a multicenter cohort study conducted by The Pediatric Fungal Network
Wattier RL , Bucayu RFT , Boge CLK , Ross RK , Yildirim I , Zaoutis TE , Palazzi DL , Vora SB , Castagnola E , Avilés-Robles M , Danziger-Isakov L , Tribble AC , Sharma TS , Arrieta AC , Maron G , Berman DM , Yin DE , Sung L , Green M , Roilides E , Belani K , Romero J , Soler-Palacin P , López-Medina E , Nolt D , Bin Hussain IZ , Muller WJ , Hauger SB , Halasa N , Dulek D , Pong A , Gonzalez BE , Abzug MJ , Carlesse F , Huppler AR , Rajan S , Aftandilian C , Ardura MI , Chakrabarti A , Hanisch B , Salvatore CM , Klingspor L , Knackstedt ED , Lutsar I , Santolaya ME , Shuster S , Johnson SK , Steinbach WJ , Fisher BT . J Pediatric Infect Dis Soc 2023 12 (9) 487-495 BACKGROUND: Adjunctive diagnostic studies (aDS) are recommended to identify occult dissemination in patients with candidemia. Patterns of evaluation with aDS across pediatric settings are unknown. METHODS: Candidemia episodes were included in a secondary analysis of a multicenter comparative effectiveness study that prospectively enrolled participants age 120 days -17 years with invasive candidiasis (predominantly candidemia) from 2014-2017. Ophthalmologic examination, abdominal imaging, echocardiogram, neuroimaging, and lumbar puncture were performed per clinician discretion. aDS performance and positive results were determined per episode, within 30 days from candidemia onset. Associations of aDS performance with episode characteristics were evaluated via mixed effects logistic regression. RESULTS: In 662 pediatric candidemia episodes, 490 (74%) underwent abdominal imaging, 450 (68%) ophthalmologic examination, 426 (64%) echocardiogram, 160 (24%) neuroimaging, and 76 (11%) lumbar puncture; performance of each aDS per episode varied across sites up to 16-fold. Longer durations of candidemia were associated with undergoing ophthalmologic examination, abdominal imaging, and echocardiogram. Immunocompromised status (58% of episodes) was associated with undergoing abdominal imaging (aOR 2.38; 95% CI 1.51-3.74). Intensive care at candidemia onset (30% of episodes) was associated with undergoing echocardiogram (aOR 2.42; 95% CI 1.51-3.88). Among evaluated episodes, positive ophthalmologic examination was reported in 15 (3%), abdominal imaging in 30 (6%), echocardiogram in 14 (3%), neuroimaging in 9 (6%) and lumbar puncture in 3 (4%). CONCLUSIONS: Our findings show heterogeneity in practice, with some clinicians performing aDS selectively, potentially influenced by clinical factors. The low frequency of positive results suggests that targeted application of aDS is warranted. |
The limit of detection of the BioFire FilmArray gastrointestinal panel for the foodborne parasite Cyclospora cayetanensis
Peterson A , Richins T , Houghton K , Mishina M , Sharma S , Sambhara S , Jacobson D , Qvarnstrom Y , Cama V . Diagn Microbiol Infect Dis 2023 107 (2) 116030 Cyclosporiasis is a foodborne diarrheal illness caused by the parasite Cyclospora cayetanensis. The BioFire® FilmArray® gastrointestinal (FilmArray GI) panel is a common method for diagnosing cyclosporiasis from clinical stool samples. The currently published limit of detection (LOD) of this panel is in genome equivalents; however, it is unclear how this relates to the number of C. cayetanensis oocysts in a clinical sample. In this study, we developed a technique to determine the LOD in terms of oocysts, using a cell sorter to sort 1 to 50 C. cayetanensis oocyst(s) previously purified from three human stool sources. We found the FilmArray GI panel detected samples with ≥20 C. cayetanensis oocysts in 100% of replicates, with varying detection among samples with 1, 5, or 10 C. cayetanensis oocysts. This method provides a parasitologically relevant LOD that should enable comparison among C. cayetanensis detection techniques, including the FilmArray GI panel. |
Enterobacterales draft genome sequences: 15 historical (1998-2004) and 30 contemporary (2015-2016) clinical isolates from Pakistan
Crawford MA , Lascols C , Lomonaco S , Timme RE , Fisher DJ , Anderson K , Hodge DR , Morse SA , Pillai SP , Sharma SK , Khan E , Allard MW , Hughes MA . Microbiol Resour Announc 2023 12 (9) e0016323 The continued emergence and spread of antimicrobial resistance among pathogenic bacteria are ever-growing threats to health and economy. Here, we report the draft genomes for 45 Enterobacterales clinical isolates, including historical and contemporary drug-resistant organisms, obtained in Pakistan between 1998 and 2016: 5 Serratia, 3 Salmonella, 3 Enterobacter, and 34 Klebsiella. |
Plasmodium falciparum infection and disease in infancy associated with increased risk of malaria and anaemia in childhood
Andronescu LR , Buchwald AG , Sharma A , Bauleni A , Mawindo P , Liang Y , Gutman JR , Mathanga DP , Chinkhumba J , Laufer MK . Malar J 2023 22 (1) 217 BACKGROUND: Infants under 6 months of age are often excluded from malaria surveillance and observational studies. The impact of malaria during early infancy on health later in childhood remains unknown. METHODS: Infants from two birth cohorts in Malawi were monitored at quarterly intervals and whenever they were ill from birth through 24 months for Plasmodium falciparum infections and clinical malaria. Poisson regression and linear mixed effects models measured the effect of exposure to malaria in infancy on subsequent malaria incidence, weight-for-age z-scores (WAZ), and haemoglobin concentrations after 6 months. RESULTS: Infants with at least one P. falciparum infection during their first 6 months had increased incidence ratio (IRR) of P. falciparum infection (IRR = 1.27, 95% CI, 1.06-1.52) and clinical malaria (IRR = 2.37, 95% CI, 2.02-2.80) compared to infants without infection. Infants with clinical malaria had increased risk of P. falciparum infection incidence between 6 and 24 months (IRR = 1.64, 95% CI, 1.38-1.94) and clinical malaria (IRR = 1.85, 95% CI, 1.48-2.32). Exposure to malaria was associated with lower WAZ over time (p = 0.02) and lower haemoglobin levels than unexposed infants at every time interval (p = 0.02). CONCLUSIONS: Infants experiencing malaria infection or clinical malaria are at increased risk of subsequent infection and disease, have poorer growth, and lower haemoglobin concentrations. |
Transmission of SARS-CoV-2 in standardised first few X cases and household transmission investigations: A systematic review and meta-analysis
Lewis HC , Marcato AJ , Meagher N , Valenciano M , Villanueva-Cabezas JP , Spirkoska V , Fielding JE , Karahalios A , Subissi L , Nardone A , Cheng B , Rajatonirina S , Okeibunor J , Aly EA , Barakat A , Jorgensen P , Azim T , Wijesinghe PR , Le LV , Rodriguez A , Vicari A , Van Kerkhove M , McVernon J , Pebody R , Price DJ , Bergeri I , Alemu MA , Alvi Y , Bukusi EA , Chung PS , Dambadarjaa D , Das AK , Dub T , Dulacha D , Ebrahim F , Gonzalez-Duarte MA , Guruge D , Heredia-Melo DC , Herman-Roloff A , Herring BL , Islam F , Jeewandara KC , Kant S , Lako R , Leite J , Malavige GN , Mandakh U , Mariam W , Mend T , Mize VA , Musa S , Nohynek H , Olu OO , Osorio-Merchan MB , Pereyaslov D , Ransom J , Ariqi LA , Khan W , Saxena S , Sharma P , Sreedevi A , Satheesh M , Subhashini KJ , Tippet-Barr BA , Usha A , Wamala JF , Watare SH , Yadav K , Inbanathan FY . Influenza Other Respir Viruses 2022 16 (5) 803-819 Abstract We aimed to estimate the household secondary infection attack rate (hSAR) of SARS-CoV-2 in investigations aligned with the WHO Unity Studies Household Transmission Investigations (HHTI) protocol. We conducted a systematic review and meta-analysis according to PRISMA 2020 guidelines. We searched Medline, Embase, Web of Science, Scopus and medRxiv/bioRxiv for “Unity-aligned” First Few X cases (FFX) and HHTIs published 1 December 2019 to 26 July 2021. Standardised early results were shared by WHO Unity Studies collaborators (to 1 October 2021). We used a bespoke tool to assess investigation methodological quality. Values for hSAR and 95% confidence intervals (CIs) were extracted or calculated from crude data. Heterogeneity was assessed by visually inspecting overlap of CIs on forest plots and quantified in meta-analyses. Of 9988 records retrieved, 80 articles (64 from databases; 16 provided by Unity Studies collaborators) were retained in the systematic review; 62 were included in the primary meta-analysis. hSAR point estimates ranged from 2% to 90% (95% prediction interval: 3%–71%; I2 = 99.7%); I2 values remained >99% in subgroup analyses, indicating high, unexplained heterogeneity and leading to a decision not to report pooled hSAR estimates. FFX and HHTI remain critical epidemiological tools for early and ongoing characterisation of novel infectious pathogens. The large, unexplained variance in hSAR estimates emphasises the need to further support standardisation in planning, conduct and analysis, and for clear and comprehensive reporting of FFX and HHTIs in time and place, to guide evidence-based pandemic preparedness and response efforts for SARS-CoV-2, influenza and future novel respiratory viruses. |
Transmission of SARS-CoV-2 in standardised First Few X cases and household transmission investigations: a systematic review and meta-analysis (preprint)
Lewis HC , Marcato AJ , Meagher N , Valenciano M , Villanueva-Cabezas JP , Spirkoska V , Fielding JE , Karahalios A , Subissi L , Nardone A , Cheng B , Rajatonirina S , Okeibunor J , Aly EA , Barakat A , Jorgensen P , Azim T , Wijesinghe PR , Le LV , Rodriguez A , Vicari A , Van Kerkhove M , McVernon J , Pebody R , Price DJ , Bergeri I , Alemu MA , Alvi Y , Bukusi EA , Chung PS , Dambadarjaa D , Das AK , Dub T , Dulacha D , Ebrahim F , Gonzalez-Duarte MA , Guruge D , Heredia-Melo DC , Herman-Roloff A , Herring BL , Islam F , Jeewandara KC , Kant S , Lako R , Leite J , Malavige GN , Mandakh U , Mariam W , Mend T , Mize VA , Musa S , Nohynek H , Olu OO , Osorio-Merchan MB , Pereyaslov D , Ransom J , Ariqi LA , Khan W , Saxena S , Sharma P , Sreedevi A , Satheesh M , Subhashini KJ , Tippet-Barr BA , Usha A , Wamala JF , Watare SH , Yadav K , Inbanathan FY . medRxiv 2022 03 (5) 803-819 We aimed to estimate the household secondary infection attack rate (hSAR) of SARS-CoV-2 in investigations aligned with the WHO Unity Studies Household Transmission Investigations (HHTI) protocol. We conducted a systematic review and meta-analysis according to PRISMA 2020 guidelines. We searched Medline, Embase, Web of Science, Scopus and medRxiv/bioRxiv for 'Unity-aligned' First Few X cases (FFX) and HHTIs published between 1 December 2019 and 26 July 2021. Standardised early results were shared by WHO Unity Studies collaborators (to 1 October 2021). We used a bespoke tool to assess investigation methodological quality. Values for hSAR and 95% confidence intervals (CIs) were extracted or calculated from crude data. Heterogeneity was assessed by visually inspecting overlap of CIs on forest plots and quantified in meta-analyses. Of 9988 records retrieved, 80 articles (64 from databases; 16 provided by Unity Studies collaborators) were retained in the systematic review and 62 were included in the primary meta-analysis. hSAR point estimates ranged from 2%-90% (95% prediction interval: 3%-71%; I2=99.7%); I2 values remained >99% in subgroup analyses, indicating high, unexplained heterogeneity and leading to a decision not to report pooled hSAR estimates. FFX and HHTI remain critical epidemiological tools for early and ongoing characterisation of novel infectious pathogens. The large, unexplained variance in hSAR estimates emphasises the need to further support standardisation in planning, conduct and analysis, and for clear and comprehensive reporting of FFX and HHTIs in time and place, to guide evidence-based pandemic preparedness and response efforts for SARS-CoV-2, influenza and future novel respiratory viruses. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license. |
Impact and cost-effectiveness of frequent HIV re-testing among key populations in Viet Nam: A modeling study (preprint)
Green D , Coomes D , Barnabas RV , Sharma M , Barrdichiara M , Jamil MS , Owiredu MN , Macdonald V , Nguyen V , Vo Hai S , Wi TE , Johnson C , Drake AL . medRxiv 2022 02 Background HIV testing and counseling is a key component of HIV prevention and the entry point into the treatment cascade, which improves for individual clinical outcomes and reduces onward HIV transmission. Current guidelines recommend at least annual testing for key populations. More frequent testing could provide health benefits, but these additional services increase the program the cost-effectiveness is not well-evaluated. Methods We used a compartmental mathematical model to simulate the health and economic impact of HIV testing one to four times per year for men who have sex with men, people who inject drugs, and female sex workers in Viet Nam. Model outcomes included costs, HIV infections, HIV-related deaths, and disability-adjusted life years (DALYs) associated with each scenario. We used an opportunity cost-based cost-effectiveness threshold of US $2,255 per DALY averted, discounted costs and health benefits at 3% annually, and used a time horizon from 2021 to 2030 to calculate incremental cost-effectiveness ratios (ICERs). Results Compared to the baseline scenario, more frequent HIV testing was estimated to incrementally avert 10.2%, 5.2%, 3.0%, and 1.6% discounted infections for one-, two-, three-, and four-tests per year, respectively. ICERs associated with each scenario ranged from $464, $1,190, $1,762, and $2,727 per DALY averted for one-, two-, three-, and four-tests per year, respectively. Conclusions Increased HIV testing frequency for key populations was projected to avert HIV incidence, mortality, and disability in Viet Nam and was cost-effective. Settings with a similar context should consider strategies on how to optimize retesting among key populations. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license. |
Case series of thrombosis with thrombocytopenia syndrome following COVID-19 vaccination-United States, December 2020-August 2021 (preprint)
See I , Lale A , Marquez P , Streiff MB , Wheeler AP , Tepper NK , Woo EJ , Broder KR , Edwards KM , Gallego R , Geller AI , Jackson KA , Sharma S , Talaat KR , Walter EB , Akpan IJ , Ortel TL , Walker SC , Yui JC , Shimabukuro TT , Mba-Jonas A , Su JR , Shay DK . medRxiv 2021 14 Background: Thrombosis with thrombocytopenia syndrome (TTS) is a potentially life-threatening condition associated with adenoviral-vectored COVID-19 vaccination. TTS presents similarly to autoimmune heparin-induced thrombocytopenia. Twelve cases of cerebral venous sinus thrombosis following Janssen/Johnson & Johnson (Ad26.COV2.S) COVID-19 vaccination have been described. Objective(s): Describe surveillance data and reporting rates of TTS cases following COVID-19 vaccination. Design(s): Case series. Setting(s): United States Patients: Case-patients reported to the Vaccine Adverse Event Reporting System (VAERS) receiving COVID-19 vaccine from December 14, 2020 through August 31, 2021, with thrombocytopenia and thrombosis (excluding isolated ischemic stroke or myocardial infarction). If thrombosis was only in an extremity vein or pulmonary embolism, a positive enzyme-linked immunosorbent assay for anti-platelet factor 4 antibody was required. Measurements: Reporting rates (cases/million vaccine doses) and descriptive epidemiology. Result(s): 52 TTS cases were confirmed following Ad26.COV2.S (n=50) or mRNA-based COVID-19 (n=2) vaccination. TTS reporting rates were 3.55 per million (Ad26.COV2.S) and 0.0057 per million (mRNA-based COVID-19 vaccines). Median age of patients with TTS following Ad26.COV2.S vaccination was 43.5 years (range: 18-70); 70% were female. Both TTS cases following mRNA-based COVID-19 vaccination occurred in males aged >50 years. All cases following Ad26.COV2.S vaccination involved hospitalization including 32 (64%) with intensive care unit admission. Outcomes of hospitalizations following Ad26.COV2.S vaccination included death (12%), discharge to post-acute care (16%), and discharge home (72%). Limitation(s): Under-reporting and incomplete case follow-up. Conclusion(s): TTS is a rare but serious adverse event associated with Ad26.COV2.S vaccination. The different demographic characteristics of the two cases reported after mRNA-based COVID-19 vaccines and the much lower reporting rate suggest that these cases represent a background rate. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Prevalence of colonization with antibiotic-resistant organisms in hospitalized and community individuals in Bangladesh, a phenotypic analysis: Findings from the Antibiotic Resistance in Communities and Hospitals (ARCH) Study
Chowdhury F , Mah EMuneer S , Bollinger S , Sharma A , Ahmed D , Hossain K , Hassan MZ , Rahman M , Vanderende D , Sen D , Mozumder P , Khan AA , Sarker M , Smith RM , Styczynski A , Luvsansharav UO . Clin Infect Dis 2023 77 S118-s124 BACKGROUND: Low- and middle-income countries bear a disproportionate burden of antimicrobial resistance (AMR) but often lack adequate surveillance to inform mitigation efforts. Colonization can be a useful metric to understand AMR burden. We assessed the colonization prevalence of Enterobacterales with resistance to extended-spectrum cephalosporins, carbapenems, colistin, and methicillin-resistant Staphylococcus aureus among hospital and community dwellers. METHODS: Between April and October 2019, we conducted a period prevalence study in Dhaka, Bangladesh. We collected stool and nasal specimens from adults in 3 hospitals and from community dwellers within the hospitals' catchment area. Specimens were plated on selective agar plates. Isolates underwent identification and antibiotic susceptibility testing using Vitek 2. We performed descriptive analysis and determined population prevalence estimates accounting for clustering at the community level. RESULTS: The majority of both community and hospital participants were colonized with Enterobacterales with resistance to extended-spectrum cephalosporins (78%; 95% confidence interval [95% CI], 73-83; and 82%; 95% CI, 79-85, respectively). Thirty-seven percent (95% CI, 34-41) of hospitalized patients were colonized with carbapenems compared with 9% (95% CI, 6-13) of community individuals. Colistin colonization prevalence was 11% (95% CI, 8-14) in the community versus 7% (95% CI, 6-10) in the hospital. Methicillin-resistant Staphylococcus aureus colonization was similar in both community and hospital participants (22%; 95% CI, 19-26 vs 21% (95% CI, 18-24). CONCLUSIONS: The high burden of AMR colonization observed among hospital and community participants may increase the risk for developing AMR infections and facilitating spread of AMR in both the community and hospital. |
Nasal shedding of vaccine viruses after immunization with a Russian-backbone live attenuated influenza vaccine in India
Dar L , Krishnan A , Kumar R , Dhakad S , Choudekar A , Bagga S , Sharma A , Kumar A , Jethani J , Saha S , Amarchand R , Kumar R , Choudhary A , Narayan VV , Gopal G , Lafond KE , Lindstrom S . Influenza Other Respir Viruses 2023 17 (6) e13149 BACKGROUND: We present post-vaccination nasal shedding findings from the phase IV, community-based, triple-blinded RCT conducted to assess efficacy of trivalent LAIV and inactivated influenza vaccines in rural north India. METHODS: Children aged 2-10 years received LAIV or intranasal placebo across 2015 and 2016, as per initial allocation. On days 2 and 4 post-vaccination, trained study nurses collected nasal swabs from randomly selected subset of trial participants based on operational feasibility, accounting for 10.0% and 11.4% of enrolled participants in 2015 and 2016, respectively. Swabs were collected in viral transport medium and transported under cold chain to laboratory for testing by reverse transcriptase real-time polymerase chain reaction. RESULTS: In year 1, on day 2 post-vaccination, 71.2% (74/104) of LAIV recipients shed at least one of vaccine virus strains compared to 42.3% (44/104) on day 4. During year 1, on day 2 post-vaccination, LAIV-A(H1N1)pdm09 was detected in nasal swabs of 12% LAIV recipients, LAIV-A(H3N2) in 41%, and LAIV-B in 59%. In year 2, virus shedding was substantially lower; 29.6% (32/108) of LAIV recipients shed one of the vaccine virus strains on day 2 compared to 21.3% on day 4 (23/108). CONCLUSION: At day 2 post-vaccination in year 1, two-thirds of LAIV recipients were shedding vaccine viruses. Shedding of vaccine viruses varied between strains and was lower in year 2. More research is needed to determine the reason for lower virus shedding and vaccine efficacy for LAIV-A(H1N1)pdm09. |
Notes from the field: Increase in meningococcal disease among persons with HIV - United States, 2022
Rubis AB , Howie RL , Marasini D , Sharma S , Marjuki H , McNamara LA . MMWR Morb Mortal Wkly Rep 2023 72 (24) 663-664 Meningococcal disease, caused by the bacterium Neisseria meningitidis, is a sudden-onset, life-threatening illness that typically occurs as meningitis or meningococcemia. The most common signs and symptoms of meningitis include fever, headache, and stiff neck; the most common signs and symptoms of meningococcemia are fever, chills, fatigue, vomiting, diarrhea, cold hands and feet, and severe aches or pain.* Quadrivalent meningococcal conjugate vaccination (MenACWY) is routinely recommended for adolescents and persons at increased risk for meningococcal disease (1), including those with HIV. In 2016, a 2-dose series of MenACWY was recommended by the Advisory Committee on Immunization Practices (ACIP) for persons with HIV and incorporated into the U.S. immunization schedule. Coverage among persons with HIV, however, remains low: in a study of administrative claims data during January 2016–March 2018, only 16.3% of persons with HIV received ≥1 doses of MenACWY vaccine within 2 years after their diagnosis (2). This report describes an increase in meningococcal disease among persons with HIV in the United States in 2022. Data are typically finalized in the fall of the next year; therefore, this report is based on preliminary data for 2022. |
Validating Wave 1 (2014) urinary cotinine and TNE-2 cut-points for differentiating Wave 4 (2017) cigarette use from non-use in the US using data from the PATH Study
Edwards KC , Khan A , Sharma E , Wang L , Feng J , Blount BC , Sosnoff CS , Smith DM , Goniewicz ML , Pearson J , Villanti AC , Delnevo CD , Bover Manderski MT , Hatsukami DK , Niaura R , Everard C , Kimmel HL , Duffy K , Rostron BL , Del Valle-Pinero AY , van Bemmel DM , Stanton CA , Hyland A . Cancer Epidemiol Biomarkers Prev 2023 32 (9) 1233-1241 BACKGROUND: Sex and racial/ethnic identity specific cut-points for validating tobacco use using Wave 1 (W1) of the PATH Study were published in 2020. The current study establishes predictive validity of the W1 (2014) urinary cotinine and Total Nicotine Equivalents-2 (TNE-2) cut-points on estimating Wave 4 (W4; 2017) tobacco use. METHODS: For exclusive and polytobacco cigarette use, weighted prevalence estimates based on W4 self-report alone and with exceeding the W1 cut-point were calculated to identify the percentage missed without biochemical verification. Sensitivity and specificity of W1 cut-points on W4 self-reported tobacco use status were examined. Receiver Operating Characteristic curves were used to determine the optimal W4 cut-points to distinguish P30D users from non-users, and evaluate if the cut-points significantly differed from W1. RESULTS: Agreement between W4 self-reported use and exceeding the W1 cut-points was high overall and when stratified by demographic subgroups (0.7- 4.4% of use was missed if relying on self-report alone). The predictive validity of using the W1 cut-points to classify exclusive cigarette and polytobacco cigarette use at W4 was high (>90% sensitivity and specificity, except among polytobacco Hispanic smokers). Cut-points derived using W4 data did not significantly differ from the W1 derived cut-points (e.g., W1 exclusive= 40.5 ng/mL cotinine [95% CI: 26.1-62.8], W4 exclusive = 29.9 ng/ml cotinine [95% CI: 13.5-66.4]), among most demographic subgroups. CONCLUSION: The W1 cut-points remain valid for biochemical verification of self-reported tobacco use in W4. IMPACT: Findings from can be used in clinical and epidemiological studies to reduce misclassification of cigarette smoking status. |
Under-recognition of measurement and management of serum ferritin among populations at high risk of iron deficiency - Authors' reply
Jefferds ME , Mei Z , Addo OY , Sharma AJ , Flores-Ayala RC , Brittenham GM . Lancet Haematol 2021 8 (11) e787-e788 We agree with Tamohiko Sato and colleagues that a paucity of ferritin measurements to detect iron deficiency in high-income, middle-income, and low-income countries restricts how well research can quantify the magnitude of the disease burden and prevent and treat the disease. Following Sato and colleagues’ suggestions, we reanalysed ferritin concentration data from the US National Health and Nutrition Examination Survey (NHANES) by age, body-mass index, and income and found no meaningful correlations. In our Article,1 we proposed a method to derive physiologically based ferritin thresholds for iron deficiency among apparently healthy young children and non-pregnant women. We concluded that this approach needs validation in non-US populations before specific threshold values are adopted. Although Sato and colleagues highlight the scarcity of ferritin data for Japan, there is also a paucity of data in the USA for populations at high risk of iron deficiency, hindering surveillance and clinical practice. NHANES measures ferritin but does not collect blood among infants younger than 12 months. Ferritin is an acute phase protein and should be adjusted for inflammation, but NHANES does not measure inflammation in all age groups consistently. Sample sizes for pregnant women are small, requiring the combining of data from approximately 10 years for dependable estimates; after 2013, NHANES stopped recording the trimester of pregnancy. The US Public Health Task Force has also emphasised the paucity of prevalence data for iron deficiency anaemia among pregnant women.2 Analysis of electronic health records for first-trimester pregnancies found that anaemia screening is virtually universal, but ferritin screening for iron deficiency is not,3 despite recommendations by the American College of Obstetrics and Gynecologists.4 We continue to search for suitable anonymised databases to examine the proposed method for deriving physiologically based thresholds for serum ferritin concentration for iron deficiency among apparently healthy individuals. Having found that some national datasets from other countries have prohibitive restrictions on their use, we welcome any suggestions of publicly available and representative ferritin data. |
Safety and effectiveness of maternal COVID-19 vaccines among pregnant people and infants
Fleming-Dutra KE , Zauche LH , Roper LE , Ellington SR , Olson CK , Sharma AJ , Woodworth KR , Tepper N , Havers F , Oliver SE , Twentyman E , Jatlaoui TC . Obstet Gynecol Clin North Am 2023 50 (2) 279-297 Evidence has consistently demonstrated that COVID-19 messenger RNA (mRNA) vaccines are safe when given during pregnancy. COVID-19 mRNA vaccines protect pregnant people and their infants who are too young to receive COVID-19 vaccines. Although generally protective, monovalent vaccine effectiveness was lower during SARS-CoV-2 Omicron variant predominance, in part due to changes in the Omicron spike protein. Bivalent vaccines, that combine ancestral strain and Omicron variant, may improve protection against Omicron variants. Everyone, including pregnant people, should stay up to date with recommended COVID-19 vaccines and bivalent booster, when eligible. |
Higher body mass index after intrapartum antibiotic exposure in children persists over 10-years
Sidell MA , Getahun D , Tartof SY , Xiang AH , Sharma AJ , Mukhopadhyay S , Puopolo KM , Schrag SJ , Kunani P , Koebnick C . Pediatr Obes 2023 18 (7) e13035 Exposure to intrapartum antibiotic prophylaxis to reduce perinatal group B streptococcal disease was associated with increased childhood body mass index (BMI) persisting to age 10 years compared to no exposure (Δ BMI at 10 years: vaginal delivery 0.14 kg/m(2) , caesarean 0.40 kg/m(2) ). |
Implementing mailed colorectal cancer fecal screening tests in real-world primary care settings: Promising implementation practices and opportunities for improvement
Hohl SD , Maxwell AE , Sharma KP , Sun J , Vu TT , DeGroff A , Escoffery C , Schlueter D , Hannon PA . Prev Sci 2023 1-12 Colorectal cancer (CRC) screening reduces morbidity and mortality, but screening rates in the USA remain suboptimal. The Colorectal Cancer Control Program (CRCCP) was established in 2009 to increase screening among groups disproportionately affected. The CRCCP utilizes implementation science to support health system change as a strategy to reduce disparities in CRC screening by directing resources to primary care clinics to implement evidence-based interventions (EBIs) proven to increase CRC screening. As COVID-19 continues to impede in-person healthcare visits and compel the unpredictable redirection of clinic priorities, understanding clinics' adoption and implementation of EBIs into routine care is crucial. Mailed fecal testing is an evidence-based screening approach that offers an alternative to in-person screening tests and represents a promising approach to reduce CRC screening disparities. However, little is known about how mailed fecal testing is implemented in real-world settings. In this retrospective, cross-sectional analysis, we assessed practices around mailed fecal testing implementation in 185 clinics across 62 US health systems. We sought to (1) determine whether clinics that do and do not implement mailed fecal testing differ with respect to characteristics (e.g., type, location, and proportion of uninsured patients) and (2) identify implementation practices among clinics that offer mailed fecal testing. Our findings revealed that over half (58%) of clinics implemented mailed fecal testing. These clinics were more likely to have a CRC screening policy than clinics that did not implement mailed fecal testing (p = 0.007) and to serve a larger patient population (p = 0.004), but less likely to have a large proportion of uninsured patients (p = 0.01). Clinics that implemented mailed fecal testing offered it in combination with EBIs, including patient reminders (92%), provider reminders (94%), and other activities to reduce structural barriers (95%). However, fewer clinics reported having the leadership support (58%) or funding stability (29%) to sustain mailed fecal testing. Mailed fecal testing was widely implemented alongside other EBIs in primary care clinics participating in the CRCCP, but multiple opportunities for enhancing its implementation exist. These include increasing the proportion of community health centers/federally qualified health centers offering mailed screening; increasing the proportion that provide pre-paid return mail supplies with the screening kit; increasing the proportion of clinics monitoring both screening kit distribution and return; ensuring patients with abnormal tests can obtain colonoscopy; and increasing sustainability planning and support. |
An outbreak of acute neurological illness associated with drinking water source following a cyclone in Eluru, West Godavari district, Andhra Pradesh, India, December 2020
Sharma S , Patel P , Kulkarni SV , Deoshatwar A , Yadav R , Tanwar S , Manohar K , Dolla JR , Jain SK , Singh SK , Dikid T . Clin Epidemiol Glob Health 2023 20 Background: In December 2020, over 500 residents of Eluru City were hospitalised with seizures and sudden loss of consciousness (LOC) resembling the neurotoxic effects of organochlorine poisoning after a flooding event during the last week of November 2020. We described the epidemiological investigation of outbreak and identified risk factors. Methods: We performed descriptive analysis followed by 1:1 unmatched case-control study. Cases were identified through house-to-house search and review of medical records at district hospital. A case defined as sudden onset LOC or new-onset seizures in an Eluru resident aged ≥1 year, December 1–15, 2020 and a control as absence of neurological symptoms in a person aged ≥1 year selected randomly from same administrative division of the case. We compared cases and controls for possible risk factors and calculated adjusted odds ratio (aOR) with 95% confidence interval (CI). Biological and environmental samples were tested for contaminants. Results: We identified 545 cases (56% males), including one death. Seizures were reported in 491 (90%) cases. Median age was 27 years (interquartile range: 17–37 years) and 480 (88%) cases resided in urban area. Cases were clustered in administrative divisions supplied by municipal water reservoirs. Cases were more likely than controls to use municipal water as primary source of drinking water (aOR = 4.6, 95% CI = 1.6–13.0). High levels (average: 14.6 mg/l) of organochlorine compounds were detected in all municipal water samples (acceptable limit: <0.001 mg/l). Conclusion: This investigation highlights water ingestion as an exposure pathway for environmental contaminants (organochlorines) in the community after largescale flooding. We recommended strengthening safe water surveillance in natural disaster response contingency plans in Eluru. © 2023 The Author(s) |
Comparison of current World Health Organization guidelines with physiologically based serum ferritin thresholds for iron deficiency in healthy young children and nonpregnant women using data from the third National Health and Nutrition Examination Survey
Mei Z , Addo OY , Jefferds MED , Sharma AJ , Flores-Ayala RC , Pfeiffer CM , Brittenham GM . J Nutr 2023 153 (3) 771-780 BACKGROUND: Current WHO serum ferritin (SF) thresholds for iron deficiency (ID) in children (<12 μg/L) and women (<15 μg/L) are derived from expert opinion based on radiometric assays in use decades ago. Using a contemporary immunoturbidimetry assay, higher thresholds (children, <20 μg/L; women, <25 μg/L) were identified from physiologically based analyses. OBJECTIVE: We examined relationships of SF measured using an immunoradiometric assay from the era of expert opinion with 2 independently measured indicators of ID, hemoglobin (Hb) and erythrocyte zinc protoporphyrin (eZnPP), using data from the Third National Health and Nutrition Examination Survey (NHANES III, 1988-1994). The SF at which circulating Hb begins to decrease and eZnPP begins to increase provides a physiological basis for identifying the onset of iron-deficient erythropoiesis. METHODS: We analyzed NHANES III cross-sectional data from 2616 apparently healthy children, aged 12-59 mo, and 4639 apparently healthy nonpregnant women, aged 15-49 y. We used restricted cubic spline regression models to determine SF thresholds for ID. RESULTS: SF thresholds identified by Hb and eZnPP did not differ significantly in children, 21.2 μg/L (95% confidence interval: 18.5, 26.5) and 18.7 μg/L (17.9, 19.7), and, in women, were similar although significantly different, 24.8 μg/L (23.4, 26.9) and 22.5 μg/L (21.7, 23.3). CONCLUSIONS: These NHANES results suggest that physiologically based SF thresholds are higher than the thresholds from expert opinion established during the same era. SF thresholds found using physiological indicators detect the onset of iron-deficient erythropoiesis, whereas the WHO thresholds identify a later, more severe stage of ID. |
Antiviral Approaches against Influenza Virus.
Kumari R , Sharma SD , Kumar A , Ende Z , Mishina M , Wang Y , Falls Z , Samudrala R , Pohl J , Knight PR , Sambhara S . Clin Microbiol Rev 2023 36 (1) e0004022 Preventing and controlling influenza virus infection remains a global public health challenge, as it causes seasonal epidemics to unexpected pandemics. These infections are responsible for high morbidity, mortality, and substantial economic impact. Vaccines are the prophylaxis mainstay in the fight against influenza. However, vaccination fails to confer complete protection due to inadequate vaccination coverages, vaccine shortages, and mismatches with circulating strains. Antivirals represent an important prophylactic and therapeutic measure to reduce influenza-associated morbidity and mortality, particularly in high-risk populations. Here, we review current FDA-approved influenza antivirals with their mechanisms of action, and different viral- and host-directed influenza antiviral approaches, including immunomodulatory interventions in clinical development. Furthermore, we also illustrate the potential utility of machine learning in developing next-generation antivirals against influenza. |
Engaging Black or African American and Hispanic or Latino men who have sex with men for HIV testing and prevention services through technology: Protocol for the iSTAMP comparative effectiveness trial
Dana R , Sullivan S , MacGowan RJ , Chavez PR , Wall KM , Sanchez TH , Stephenson R , Hightow-Weidman L , Johnson JA , Smith A , Sharma A , Jones J , Hannah M , Trigg M , Luo W , Caldwell J , Sullivan PS . JMIR Res Protoc 2023 12 e43414 BACKGROUND: Gay, bisexual, and other men who have sex with men (MSM), particularly Black or African American MSM (BMSM) and Hispanic or Latino MSM (HLMSM), continue to be disproportionately affected by the HIV epidemic in the United States. Previous HIV self-testing programs have yielded high testing rates, although these studies predominantly enrolled White, non-Hispanic MSM. Mobile health tools can support HIV prevention, testing, and treatment. This protocol details an implementation study of mailing free HIV self-tests (HIVSTs) nested within a randomized controlled trial designed to assess the benefit of a mobile phone app for increasing the uptake of HIV prevention and other social services. OBJECTIVE: This study was a comparative effectiveness trial of innovative recruitment and testing promotion strategies intended to effectively reach cisgender BMSM and HLMSM. We evaluated the use of a mobile app for increasing access to care. METHODS: Study development began with individual and group consultations that elicited feedback from 3 core groups: HIV care practitioners and researchers, HIV service organization leaders from study states, and BMSM and HLMSM living in the study states. Upon completion of the formative qualitative work, participants from 11 states, based on the observed areas of highest rate of new HIV diagnoses among Black and Hispanic MSM, were recruited through social networking websites and smartphone apps. After eligibility was verified, participants consented and were randomized to the intervention arm (access to the Know@Home mobile app) or the control arm (referral to web resources). We provided all participants with HIVSTs. The evaluation of the efficacy of a mobile phone app to support linkage to posttest prevention services that included sexually transmitted infection testing, pre-exposure prophylaxis initiation, antiretroviral treatment, and acquisition of condoms and compatible lubricants has been planned. Data on these outcomes were obtained from several sources, including HIVST-reporting surveys, the 4-month follow-up survey, laboratory analyses of dried blood spot cards returned by the participant, and data obtained from the state health department surveillance systems. Where possible, relevant subgroup analyses were performed. RESULTS: During the formative development phase, 9 consultations were conducted: 6 in-depth individual discussions and 3 group consultations. From February 2020 through February 2021, we enrolled 2093 MSM in the randomized controlled trial from 11 states, 1149 BMSM and 944 HLMSM. CONCLUSIONS: This study was designed and implemented to evaluate the effectiveness of recruitment strategies to reach BMSM and HMSM and of a mobile app with regard to linkage to HIV prevention or treatment services. Data were also obtained to allow for the analyses of cost and cost-effectiveness related to study enrollment, HIV testing uptake, identification of previously undiagnosed HIV, sexually transmitted infection testing and treatment, and linkage to HIV prevention or treatment services. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04219878); https://clinicaltrials.gov/ct2/show/NCT04219878. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43414. |
Postdelivery intervention to prevent type 2 diabetes and the cost-effectiveness of screening criteria for gestational diabetes
Neuwahl SJ , Sharma AJ , Zhang P , Hoerger TJ . Prev Chronic Dis 2022 19 E89 PURPOSE AND OBJECTIVES: The objective of our study was to model the costs and benefits of 2 screening criteria for people with gestational diabetes. Because people with a history of gestational diabetes are at increased risk for type 2 diabetes, we modeled the effects of a postdelivery intervention based on the Diabetes Prevention Program, which is offered to all people with a history of gestational diabetes defined by either set of criteria. INTERVENTION APPROACH: We used a probabilistic decision tree model to compare the cost-effectiveness of the International Association of Diabetes in Pregnancy Study Group's (IADPSG's) screening criteria and the Carpenter-Coustan screening criteria for gestational diabetes through delivery and a follow-up period during which people might develop type 2 diabetes after pregnancy. EVALUATION METHODS: The model included perinatal outcomes for the infant and mother and a 10-year postdelivery period to model maternal progression to type 2 diabetes. The model assumed the health care system perspective. People with gestational diabetes received treatment for gestational diabetes during pregnancy, and we assumed that 10% would participate in a Diabetes Prevention Program-based postdelivery intervention to reduce the risk of type 2 diabetes. We estimated the cost-effectiveness of each screening strategy in quality-adjusted life-years (QALYs) in 2022 dollars. RESULTS: At 10% participation in a Diabetes Prevention Program-based postdelivery intervention, the Carpenter-Coustan criteria were cost-effective, compared with no screening ($66,085 per QALY). The IADPSG screening criteria were slightly less cost-effective, compared with no screening ($97,878 per QALY) or Carpenter-Coustan screening criteria ($122,279 per QALY). With participation rates of 23% or higher, the IADPSG screening criteria were highly cost-effective ($48,588 per QALY), compared with Carpenter-Coustan screening criteria. IMPLICATIONS FOR PUBLIC HEALTH: Diagnosing a larger proportion of pregnant people using the IADPSG screening criteria, compared with using Carpenter-Coustan screening criteria, is not cost-effective at low levels of participation. However, with moderate levels of participation (23%) in a Diabetes Prevention Program-based postdelivery intervention, the expanded IADPSG screening criteria are cost-effective and reach up to 4 times as many people as Carpenter-Coustan screening. |
Prevalence of colonization with multidrug-resistant bacteria in communities and hospitals in Kenya.
Ita T , Luvsansharav UO , Smith RM , Mugoh R , Ayodo C , Oduor B , Jepleting M , Oguta W , Ouma C , Juma J , Bigogo G , Kariuki S , Ramay BM , Caudell M , Onyango C , Ndegwa L , Verani JR , Bollinger S , Sharma A , Palmer GH , Call DR , Omulo S . Sci Rep 2022 12 (1) 22290 We estimated the prevalence of extended-spectrum cephalosporin-resistant Enterobacterales (ESCrE), carbapenem-resistant Enterobacterales (CRE), and methicillin-resistant Staphylococcus aureus (MRSA) in communities and hospitals in Kenya to identify human colonization with multidrug-resistant bacteria. Nasal and fecal specimen were collected from inpatients and community residents in Nairobi (urban) and Siaya (rural) counties. Swabs were plated on chromogenic agar to presumptively identify ESCrE, CRE and MRSA isolates. Confirmatory identification and antibiotic susceptibility testing were done using the VITEK®2 instrument. A total of 1999 community residents and 1023 inpatients were enrolled between January 2019 and March 2020. ESCrE colonization was higher in urban than rural communities (52 vs. 45%; P = 0.013) and in urban than rural hospitals (70 vs. 63%; P = 0.032). Overall, ESCrE colonization was ~ 18% higher in hospitals than in corresponding communities. CRE colonization was higher in hospital than community settings (rural: 7 vs. 1%; urban: 17 vs. 1%; with non-overlapping 95% confidence intervals), while MRSA was rarely detected (≤ 3% overall). Human colonization with ESCrE and CRE was common, particularly in hospitals and urban settings. MRSA colonization was uncommon. Evaluation of risk factors and genetic mechanisms of resistance can guide prevention and control efforts tailored to different environments. |
- Page last reviewed:Feb 1, 2024
- Page last updated:Apr 22, 2024
- Content source:
- Powered by CDC PHGKB Infrastructure