Last data update: Apr 22, 2024. (Total: 46599 publications since 2009)
Records 1-30 (of 595 Records) |
Query Trace: Bias M [original query] |
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Systematic review of empiric studies on lockdowns, workplace closures, and other non-pharmaceutical interventions in non-healthcare workplaces during the initial year of the COVID-19 pandemic: benefits and selected unintended consequences
Ahmed F , Shafer L , Malla P , Hopkins R , Moreland S , Zviedrite N , Uzicanin A . BMC Public Health 2024 24 (1) 884 BACKGROUND: We conducted a systematic review aimed to evaluate the effects of non-pharmaceutical interventions within non-healthcare workplaces and community-level workplace closures and lockdowns on COVID-19 morbidity and mortality, selected mental disorders, and employment outcomes in workers or the general population. METHODS: The inclusion criteria included randomized controlled trials and non-randomized studies of interventions. The exclusion criteria included modeling studies. Electronic searches were conducted using MEDLINE, Embase, and other databases from January 1, 2020, through May 11, 2021. Risk of bias was assessed using the Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) tool. Meta-analysis and sign tests were performed. RESULTS: A total of 60 observational studies met the inclusion criteria. There were 40 studies on COVID-19 outcomes, 15 on anxiety and depression symptoms, and five on unemployment and labor force participation. There was a paucity of studies on physical distancing, physical barriers, and symptom and temperature screening within workplaces. The sign test indicated that lockdown reduced COVID-19 incidence or case growth rate (23 studies, p < 0.001), reproduction number (11 studies, p < 0.001), and COVID-19 mortality or death growth rate (seven studies, p < 0.05) in the general population. Lockdown did not have any effect on anxiety symptoms (pooled standardized mean difference = -0.02, 95% CI: -0.06, 0.02). Lockdown had a small effect on increasing depression symptoms (pooled standardized mean difference = 0.16, 95% CI: 0.10, 0.21), but publication bias could account for the observed effect. Lockdown increased unemployment (pooled mean difference = 4.48 percentage points, 95% CI: 1.79, 7.17) and decreased labor force participation (pooled mean difference = -2.46 percentage points, 95% CI: -3.16, -1.77). The risk of bias for most of the studies on COVID-19 or employment outcomes was moderate or serious. The risk of bias for the studies on anxiety or depression symptoms was serious or critical. CONCLUSIONS: Empiric studies indicated that lockdown reduced the impact of COVID-19, but that it had notable unwanted effects. There is a pronounced paucity of studies on the effect of interventions within still-open workplaces. It is important for countries that implement lockdown in future pandemics to consider strategies to mitigate these unintended consequences. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration # CRD42020182660. |
The National Wastewater Surveillance System (NWSS): From inception to widespread coverage, 2020-2022, United States
Adams C , Bias M , Welsh RM , Webb J , Reese H , Delgado S , Person J , West R , Shin S , Kirby A . Sci Total Environ 2024 171566 Wastewater surveillance is a valuable tool that can be used to track infectious diseases in a community. In September 2020, the Centers for Disease Control and Prevention (CDC) established the National Wastewater Surveillance System (NWSS) to coordinate and build the nation's capacity to detect and quantify concentrations of SARS-CoV-2 RNA in U.S. wastewater. This is the first surveillance summary of NWSS, covering September 1, 2020 to December 31, 2022. Through partnerships with state, tribal, local, and territorial health departments, NWSS became a national surveillance platform that can be readily expanded and adapted to meet changing public health needs. Beginning with 209 sampling sites in September 2020, NWSS rapidly expanded to >1500 sites by December 2022, covering ≈47 % of the U.S. population. As of December 2022, >152,000 unique wastewater samples have been collected by NWSS partners, primarily from wastewater treatment plants (WWTPs). WWTPs participating in NWSS tend to be larger than the average U.S. WWTP and serve more populated communities. In December 2022, ≈8 % of the nearly 16,000 U.S. WWTPs were participating in NWSS. NWSS partners used a variety of methods for sampling and testing wastewater samples; however, progress is being made to standardize these methods. In July 2021, NWSS partners started submitting SARS-CoV-2 genome sequencing data to NWSS. In October 2022, NWSS expanded to monkeypox virus testing, with plans to include additional infectious disease targets in the future. Through the rapid implementation and expansion of NWSS, important lessons have been learned. Wastewater surveillance programs should consider both surge and long-term capacities when developing an implementation plan, and early standardization of sampling and testing methods is important to facilitate data comparisons across sites. NWSS has proven to be a flexible and sustainable surveillance system that will continue to be a useful complement to case-based surveillance for guiding public health action. |
Viral shedding of SARS-CoV-2 in body fluids associated with sexual activity: a systematic review and meta-analysis
Calvet GA , Kara E , Gonsalves L , Seuc AH , de Oliveira RVC , Thwin SS , Gomez Ponce de León R , Gámez MC , Peña GM , Pendás BVR , Alzugaray MG , Carballo GO , Cala DC , Guimarães PMQ , Bonet M , Taylor M , Thorson A , Kim C , Ali M , Broutet N . BMJ Open 2024 14 (2) e073084 OBJECTIVE: To identify and summarise the evidence on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA detection and persistence in body fluids associated with sexual activity (saliva, semen, vaginal secretion, urine and faeces/rectal secretion). ELIGIBILITY: All studies that reported detection of SARS-CoV-2 in saliva, semen, vaginal secretion, urine and faeces/rectal swabs. INFORMATION SOURCES: The WHO COVID-19 database from inception to 20 April 2022. RISK OF BIAS ASSESSMENT: The National Institutes of Health tools. SYNTHESIS OF RESULTS: The proportion of patients with positive results for SARS-CoV-2 and the proportion of patients with a viral duration/persistence of at least 14 days in each fluid was calculated using fixed or random effects models. INCLUDED STUDIES: A total of 182 studies with 10 023 participants. RESULTS: The combined proportion of individuals with detection of SARS-CoV-2 was 82.6% (95% CI: 68.8% to 91.0%) in saliva, 1.6% (95% CI: 0.9% to 2.6%) in semen, 2.7% (95% CI: 1.8% to 4.0%) in vaginal secretion, 3.8% (95% CI: 1.9% to 7.6%) in urine and 31.8% (95% CI: 26.4% to 37.7%) in faeces/rectal swabs. The maximum viral persistence for faeces/rectal secretions was 210 days, followed by semen 121 days, saliva 112 days, urine 77 days and vaginal secretions 13 days. Culturable SARS-CoV-2 was positive for saliva and faeces. LIMITATIONS: Scarcity of longitudinal studies with follow-up until negative results. INTERPRETATION: SARS-CoV-2 RNA was detected in all fluids associated with sexual activity but was rare in semen and vaginal secretions. Ongoing droplet precautions and awareness of the potential risk of contact with faecal matter/rectal mucosa are needed. PROSPERO REGISTRATION NUMBER: CRD42020204741. |
Investigating the current harmonization status of tumor markers using global external quality assessment programs: A feasibility study
van Rossum HH . Clin Chem 2024 BACKGROUND: The harmonization status of most tumor markers (TMs) is unknown. We report a feasibility study performed to determine whether external quality assessment (EQA) programs can be used to obtain insights into the current harmonization status of the tumor markers α-fetoprotein (AFP), prostate specific antigen (PSA), carcinoembryonic antigen (CEA), cancer antigen (CA)125, CA15-3 and CA19-9. METHODS: EQA sample results provided by 6 EQA providers (INSTAND [Germany], Korean Association of External Quality Assessment Service [KEQAS, South Korea], National Center for Clinical Laboratories [NCCL, China], United Kingdom National External Quality Assessment Service [UK NEQAS, United Kingdom], Stichting Kwaliteitsbewaking Medische Laboratoriumdiagnostiek [SKML, the Netherlands], and the Royal College of Pathologists of Australasia Quality Assurance Programs [RCPAQAP, Australia]) between 2020 and 2021 were used. The consensus means, calculated from the measurement procedures present in all EQA programs (Abbott Alinity, Beckman Coulter DxI, Roche Cobas, and Siemens Atellica), was used as reference values. Per measurement procedure, the relative difference between consensus mean for each EQA sample and the mean of all patient-pool-based EQA samples were calculated and compared to minimum, desirable, and optimal allowable bias criteria based on biological variation. RESULTS: Between 19040 (CA15-3) and 25398 (PSA) individual results and 56 (PSA) to 76 (AFP) unique EQA samples were included in the final analysis. The mean differences with the consensus mean of patient-pool-based EQA samples for all measurement procedures were within the optimum bias criterion for AFP, the desirable bias for PSA, and the minimum bias criterion for CEA. However, CEA results <8 µg/L exceeded the minimum bias criterion. For CA125, CA15-3, and CA19-9, the harmonization status was outside the minimum bias criterion, with systematic differences identified. CONCLUSIONS: This study provides relevant information about the current harmonization status of 6 tumor markers. A pilot harmonization investigation for CEA, CA125, CA15-3, and CA19-9 would be desirable. |
Region-wide assessment of National Immunization Technical Advisory Groups (NITAGs) using the NITAG Maturity Assessment Tool (NMAT) - Experience from the Eastern Mediterranean Region of the World Health Organization, 2023
Sume GE . Vaccine 2024 National Immunization Technical Advisory Groups (NITAGs) are independent bodies that help improve national immunization programmes in decision making on immunization policy. The new NITAG Maturity Assessment Tool (NMAT) provided an opportunity to conduct a region-wide assessment to improve NITAG capacity and foster institutional growth. We share experience of the Eastern Mediterranean Region (EMR) of the World Health Organization (WHO) in using NMAT and the use of findings to develop improvement plans. NITAG chairs and secretariats from 22 EMR countries attended a virtual NMAT training in 2023. They self-assessed their NITAGs using the tool and developed improvement plans. An algorithm used the data to determine maturity levels for seven indicators. We consolidated results for the region by income groups. Of 22 countries (or NITAGs), 20 (91%) submitted NITAG assessment findings and 19 an improvement plan. The proportion of criteria met per indicator varied from 36% for independence and non-bias to 74% for establishment and composition. Maturity level varied by indicator. Of 20 NITAGs, less than half had an intermediate or higher-level maturity for the indicators of independence and non-bias 1 (5%), operations 3 (15%), making recommendations 4 (20%), stakeholder recognition 6 (30%), and resources and secretariat support 7 (35%). Meanwhile 11 (55%) NITAGs had an intermediate or higher maturity level for the indicators of establishment and composition and for integration into policy making process. Participants described NMAT as a concise, useful, user-friendly tool. NMAT is a practical tool that can be used by NITAGs to provide insights and strategic direction for individual countries and regionally. Prevention and management of conflict of interest is the domain that requires the most improvement in EMR. Planned activities should be implemented, monitored and a follow up assessment conducted in 2025. |
Mortality risk after COVID-19 vaccination: A self-controlled case series study
Xu S . Vaccine 2024 BACKGROUND: Although previous studies found no-increased mortality risk after COVID-19 vaccination, residual confounding bias might have impacted the findings. Using a modified self-controlled case series (SCCS) design, we assessed the risk of non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes after primary series COVID-19 vaccination. METHODS: We analyzed all deaths between December 14, 2020, and August 11, 2021, among individuals from eight Vaccine Safety Datalink sites. Demographic characteristics of deaths in recipients of COVID-19 vaccines and unvaccinated individuals were reported. We conducted SCCS analyses by vaccine type and death outcomes and reported relative incidences (RI). The observation period for death spanned from the dates of emergency use authorization to the end of the study period (August 11, 2021) without censoring the observation period upon death. We pre-specified a primary risk interval of 28-day and a secondary risk interval of 14-day after each vaccination dose. Adjusting for seasonality in mortality analyses is crucial because death rates vary over time. Deaths among unvaccinated individuals were included in SCCS analyses to account for seasonality by incorporating calendar month in the models. RESULTS: For Pfizer-BioNTech (BNT162b2), RIs of non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes were below 1 and 95 % confidence intervals (CIs) excluded 1 across both doses and both risk intervals. For Moderna (mRNA-1273), RI point estimates of all outcomes were below 1, although the 95 % CIs of two RI estimates included 1: cardiac-related (RI = 0.78, 95 % CI, 0.58-1.04) and non-COVID-19 cardiac-related mortality (RI = 0.80, 95 % CI, 0.60-1.08) 14 days after the second dose in individuals without pre-existing cancer and heart disease. For Janssen (Ad26.COV2.S), RIs of four cardiac-related death outcomes ranged from 0.94 to 0.98 for the 14-day risk interval, and 0.68 to 0.72 for the 28-day risk interval and 95 % CIs included 1. CONCLUSION: Using a modified SCCS design and adjusting for temporal trends, no-increased risk was found for non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes among recipients of the three COVID-19 vaccines used in the US. |
Can sodium and potassium measured in timed voids be used as reference instruments for validating self-report instruments? Results from a urine calibration study
Freedman LS . Am J Clin Nutr 2024 BACKGROUND: Sodium and potassium measured in 24-hour urine collections are often used as reference measurements to validate self-reported dietary intake instruments. OBJECTIVE: To evaluate whether collection and analysis of a limited number of urine voids at specified times during the day ("timed voids") can provide alternative reference measurements, and to identify their optimal number and timing. METHODS: We used data from a urine calibration study among 441 adults aged 18-39 years. Participants collected each urine void in a separate container for 24 hours and recorded collection time. For the same day, they reported dietary intake using a 24-hour recall. Urinary sodium and potassium were analyzed in a 24-hour composite sample and in four timed voids (morning, afternoon, evening and overnight). Using linear regression models, equations predicting log-transformed 24-hour urinary sodium or potassium level were developed using each of the four single timed voids, six pairs and four triples. The equations also included age, sex, race, body mass index and log creatinine. Optimal combinations minimizing the mean squared prediction error were selected, and the observed and predicted 24-hour levels were then used as reference measures to estimate the group bias and attenuation factors of the 24-hour dietary recall. These estimates were compared. RESULTS: Optimal combinations found were: single voids - Evening; paired voids - Afternoon+Overnight (sodium) and Morning+Evening (potassium); triple voids - Morning+Evening+Overnight (sodium) and Morning+Afternoon+Evening (potassium). Predicted 24-hour urinary levels estimated 24-hour recall group biases and attenuation factors without apparent bias, but with less precision than observed 24-hour urinary levels. To recover lost precision, it was estimated that sample sizes need to be larger by about 2.6-2.7 times for a single void, 1.7-2.1 times for paired voids and 1.5-1.6 times for triple voids. CONCLUSIONS: Our results lay the basis for further development of new reference biomarkers based on timed voids. CLINICAL TRIAL REGISTRY: Home ClinicalTrials.govas NCT01631240. |
A Community Guide Systematic Review: Digital HIV pre-exposure prophylaxis interventions
Kamitani E , Peng Y , Hopkins D , Higa DH , Mullins MM . Am J Prev Med 2024 INTRODUCTION: HIV preexposure prophylaxis (PrEP) is highly effective when taken as prescribed. Digital health adherence interventions have been identified as effective for improving antiretroviral therapy adherence among people with HIV, but limited evidence exists for PrEP adherence interventions among people without HIV. The purpose of this Community Guide systematic review was to present the characteristics and effectiveness of digital PrEP adherence interventions. METHODS: The author searched the CDC HIV Prevention Research Synthesis cumulative database for digital health interventions with PrEP adherence outcomes published in peer-reviewed journals from 2000-2022. Studies with comparison arms or pre-post data evaluating interventions in high-income countries were included. Two reviewers independently screened citations, extracted data, conducted risk of bias assessment, and resolved discrepancies through discussion. Summary effect estimates were calculated using median and interquartile interval. RESULTS: Nine studies were included and all focused on gay, bisexual, and other men who have sex with men. Eight studies were U.S.-based while the other was conducted in the Netherlands. Five were randomized control trials and four were pre-/post studies. All studies showed improved adherence in the intervention arms compared with comparison groups or pre-intervention data. One study also reported improvement in PrEP care retention. DISCUSSION: Digital health adherence interventions with different strategies to improve PrEP and HIV-related outcomes were identified. The small number of studies identified is a limitation. Findings from this review served as the basis for the Community Preventive Services Task Force recommendation to use these interventions to increase PrEP adherence to prevent HIV infection. |
Association of economic policies with hypertension management and control: A systematic review
Zhang D , Lee JS , Pollack LM , Dong X , Taliano JM , Rajan A , Therrien NL , Jackson SL , Popoola A , Luo F . JAMA Health Forum 2024 5 (2) e235231 IMPORTANCE: Economic policies have the potential to impact management and control of hypertension. OBJECTIVES: To review the evidence on the association between economic policies and hypertension management and control among adults with hypertension in the US. EVIDENCE REVIEW: A search was carried out of PubMed/MEDLINE, Cochrane Library, Embase, PsycINFO, CINAHL, EconLit, Sociological Abstracts, and Scopus from January 1, 2000, through November 1, 2023. Included were randomized clinical trials, difference-in-differences, and interrupted time series studies that evaluated the association of economic policies with hypertension management. Economic policies were grouped into 3 categories: insurance coverage expansion such as Medicaid expansion, cost sharing in health care such as increased drug copayments, and financial incentives for quality such as pay-for-performance. Antihypertensive treatment was measured as taking antihypertensive medications or medication adherence among those who have a hypertension diagnosis; and hypertension control, measured as blood pressure (BP) lower than 140/90 mm Hg or a reduction in BP. Evidence was extracted and synthesized through dual review of titles, abstracts, full-text articles, study quality, and policy effects. FINDINGS: In total, 31 articles were included. None of the studies examined economic policies outside of the health care system. Of these, 16 (52%) assessed policies for insurance coverage expansion, 8 (26%) evaluated policies related to patient cost sharing for prescription drugs, and 7 (22%) evaluated financial incentive programs for improving health care quality. Of the 16 studies that evaluated coverage expansion policies, all but 1 found that policies such as Medicare Part D and Medicaid expansion were associated with significant improvement in antihypertensive treatment and BP control. Among the 8 studies that examined patient cost sharing, 4 found that measures such as prior authorization and increased copayments were associated with decreased adherence to antihypertensive medication. Finally, all 7 studies evaluating financial incentives aimed at improving quality found that they were associated with improved antihypertensive treatment and BP control. Overall, most studies had a moderate or low risk of bias in their policy evaluation. CONCLUSIONS AND RELEVANCE: The findings of this systematic review suggest that economic policies aimed at expanding insurance coverage or improving health care quality successfully improved medication use and BP control among US adults with hypertension. Future research is needed to investigate the potential effects of non-health care economic policies on hypertension control. |
Utilizing a university testing program to estimate relative effectiveness of monovalent COVID-19 mRNA booster vaccine versus two-dose primary series against symptomatic SARS-CoV-2 infection
Bennett JC , Luiten KG , O'Hanlon J , Han PD , McDonald D , Wright T , Wolf CR , Lo NK , Acker Z , Regelbrugge L , McCaffrey KM , Pfau B , Stone J , Schwabe-Fry K , Lockwood CM , Guthrie BL , Gottlieb GS , Englund JA , Uyeki TM , Carone M , Starita LM , Weil AA , Chu HY . Vaccine 2024 Vaccine effectiveness (VE) studies utilizing the test-negative design are typically conducted in clinical settings, rather than community populations, leading to bias in VE estimates against mild disease and limited information on VE in healthy young adults. In a community-based university population, we utilized data from a large SARS-CoV-2 testing program to estimate relative VE of COVID-19 mRNA vaccine primary series and monovalent booster dose versus primary series only against symptomatic SARS-CoV-2 infection from September 2021 to July 2022. We used the test-negative design and logistic regression implemented via generalized estimating equations adjusted for age, calendar time, prior SARS-CoV-2 infection, and testing frequency (proxy for test-seeking behavior) to estimate relative VE. Analyses included 2,218 test-positive cases (59 % received monovalent booster dose) and 9,615 test-negative controls (62 %) from 9,066 individuals, with median age of 21 years, mostly students (71 %), White (56 %) or Asian (28 %), and with few comorbidities (3 %). More cases (23 %) than controls (6 %) had COVID-19-like illness. Estimated adjusted relative VE of primary series and monovalent booster dose versus primary series only against symptomatic SARS-CoV-2 infection was 40 % (95 % CI: 33-47 %) during the overall analysis period and 46 % (39-52 %) during the period of Omicron circulation. Relative VE was greater for those without versus those with prior SARS-CoV-2 infection (41 %, 34-48 % versus 33 %, 9 %-52 %, P < 0.001). Relative VE was also greater in the six months after receiving a booster dose (41 %, 33-47 %) compared to more than six months (27 %, 8-42 %), but this difference was not statistically significant (P = 0.06). In this relatively young and healthy adult population, an mRNA monovalent booster dose provided increased protection against symptomatic SARS-CoV-2 infection, overall and with the Omicron variant. University testing programs may be utilized for estimating VE in healthy young adults, a population that is not well-represented by routine VE studies. |
Tularemia clinical manifestations, antimicrobial treatment, and outcomes: An analysis of US surveillance data, 2006-2021
Wu HJ , Bostic TD , Horiuchi K , Kugeler KJ , Mead PS , Nelson CA . Clin Infect Dis 2024 78 S29-s37 BACKGROUND: Tularemia, a potentially fatal zoonosis caused by Francisella tularensis, has been reported from nearly all US states. Information on relative effectiveness of various antimicrobials for treatment of tularemia is limited, particularly for newer classes such as fluoroquinolones. METHODS: Data on clinical manifestations, antimicrobial treatment, and illness outcome of patients with tularemia are provided voluntarily through case report forms to the US Centers for Disease Control and Prevention by state and local health departments. We summarized available demographic and clinical information submitted during 2006-2021 and evaluated survival according to antimicrobial treatment. We grouped administered antimicrobials into those considered effective for treatment of tularemia (aminoglycosides, fluoroquinolones, and tetracyclines) and those with limited efficacy. Logistic regression models with a bias-reduced estimation method were used to evaluate associations between antimicrobial treatment and survival. RESULTS: Case report forms were available for 1163 US patients with tularemia. Francisella tularensis was cultured from a clinical specimen (eg, blood, pleural fluid) in approximately half of patients (592; 50.9%). Nearly three-quarters (853; 73.3%) of patients were treated with a high-efficacy antimicrobial. A total of 27 patients (2.3%) died. After controlling for positive culture as a proxy for illness severity, use of aminoglycosides, fluoroquinolones, and tetracyclines was independently associated with increased odds of survival. CONCLUSIONS: Most US patients with tularemia received high-efficacy antimicrobials; their use was associated with improved odds of survival regardless of antimicrobial class. Our findings provide supportive evidence that fluoroquinolones are an effective option for treatment of tularemia. |
Compare the marginal effects for environmental exposure and biomonitoring data with repeated measurements and values below the limit of detection
Chen IC , Bertke SJ , Estill CF . J Expo Sci Environ Epidemiol 2024 BACKGROUND: Environmental exposure and biomonitoring data with repeated measurements from environmental and occupational studies are commonly right-skewed and in the presence of limits of detection (LOD). However, existing model has not been discussed for small-sample properties and highly skewed data with non-detects and repeated measurements. OBJECTIVE: Marginal modeling provides an alternative to analyzing longitudinal and cluster data, in which the parameter interpretations are with respect to marginal or population-averaged means. METHODS: We outlined the theories of three marginal models, i.e., generalized estimating equations (GEE), quadratic inference functions (QIF), and generalized method of moments (GMM). With these approaches, we proposed to incorporate the fill-in methods, including single and multiple value imputation techniques, such that any measurements less than the limit of detection are assigned values. RESULTS: We demonstrated that the GEE method works well in terms of estimating the regression parameters in small sample sizes, while the QIF and GMM outperform in large-sample settings, as parameter estimates are consistent and have relatively smaller mean squared error. No specific fill-in method can be deemed superior as each has its own merits. IMPACT: Marginal modeling is firstly employed to analyze repeated measures data with non-detects, in which only the mean structure needs to be correctly provided to obtain consistent parameter estimates. After replacing non-detects through substitution methods and utilizing small-sample bias corrections, in a simulation study we found that the estimating approaches used in the marginal models have corresponding advantages under a wide range of sample sizes. We also applied the models to longitudinal and cluster working examples. |
Detecting Mpox cases through wastewater surveillance - United States, August 2022-May 2023
Adams C , Kirby AE , Bias M , Riser A , Wong KK , Mercante JW , Reese H . MMWR Morb Mortal Wkly Rep 2024 73 (2) 37-43 In October 2022, CDC's National Wastewater Surveillance System began routine testing of U.S. wastewater for Monkeypox virus. Wastewater surveillance sensitivity, positive predictive value (PPV), and negative predictive value (NPV) for Monkeypox virus were evaluated by comparing wastewater detections (Monkeypox virus detected versus not detected) to numbers of persons with mpox in a county who were shedding virus. Case ascertainment was assumed to be complete, and persons with mpox were assumed to shed virus for 25 days after symptom onset. A total of 281 cases and 3,492 wastewater samples from 89 sites in 26 counties were included in the analysis. Wastewater surveillance in a single week, from samples representing thousands to millions of persons, had a sensitivity of 32% for detecting one or more persons shedding Monkeypox virus, 49% for detecting five or more persons shedding virus, and 77% for detecting 15 or more persons shedding virus. Weekly PPV and NPV for detecting persons shedding Monkeypox virus in a county were 62% and 80%, respectively. An absence of detections in counties with wastewater surveillance signified a high probability that a large number of cases were not present. Results can help to guide the public health response to Monkeypox virus wastewater detections. A single, isolated detection likely warrants a limited public health response. An absence of detections, in combination with no reported cases, can give public health officials greater confidence that no cases are present. Wastewater surveillance can serve as a useful complement to case surveillance for guiding the public health response to an mpox outbreak. |
Estimates of congenital cytomegalovirus-attributable infant mortality in high-income countries: A review
Grosse SD , Fleming P , Pesch MH , Rawlinson WD . Rev Med Virol 2024 34 (1) e2502 As many as 5%–10% of infants with symptomatic congenital cytomegalovirus (cCMV) disease, or 0.4%–0.8% of all liveborn infants with cCMV infection, die in early infancy in high-income countries. However, estimates are uncertain due to several potential biases that can result from data limitations and study designs. First, infants with cCMV infections who die prior to diagnosis, which usually occurs at 1–4 weeks after birth, may be excluded from both the count of deaths and the denominator of cCMV births, resulting in left truncation and immortal time biases. These ‘biases’ are features of the data and do not reflect bias on the part of researchers, but understanding the potential existence of threats to validity can help with interpretation of findings. Left truncation of infant deaths occurring prior to diagnosis of cCMV can result in understatement of the burden of infant deaths due to cCMV. Conversely, overestimation of infant deaths associated with symptomatic cCMV may occur in clinical case series owing to greater representation of relatively severely affected infants owing to ascertainment and referral biases. In this review, we summarise the characteristics of 26 studies that reported estimates of cCMV-associated infant deaths, including potential biases or limitations to which those estimates may have been subject. We discuss study designs whose implementation might generate improved estimates of infant deaths attributable to cCMV. More complete estimates of the overall public health impact of cCMV could inform current and future screening, prevention, and vaccine research. © 2024 John Wiley & Sons Ltd. |
JYNNEOS™ effectiveness as post-exposure prophylaxis against Mpox: Challenges using real-world outbreak data
Rosen JB , Arciuolo RJ , Pathela P , Boyer CB , Baumgartner J , Latash J , Malec L , Lee EH , Reddy V , King R , Edward Real J , Lipsitch M , Zucker JR . Vaccine 2024 BACKGROUND: JYNNEOS(TM) vaccine has been used as post-exposure prophylaxis (PEP) during a mpox outbreak in New York City (NYC). Data on effectiveness are limited. METHODS: Effectiveness of a single dose of JYNNEOS(TM) vaccine administered subcutaneously ≤ 14 days as PEP for preventing mpox disease was assessed among individuals exposed to case-patients from May 22, 2022-August 24, 2022. Individuals were evaluated for mpox through 21 days post-exposure. An observational study was conducted emulating a sequence of nested "target" randomized trials starting each day after exposure. Results were adjusted for exposure risk and race/ethnicity. Analyses were conducted separately based on last (PEP(L)) and first (PEP(F)) exposure date. We evaluated the potential to overestimate PEP effectiveness when using conventional analytic methods due to exposed individuals developing illness before they can obtain PEP (immortal time bias) compared to the target trial. RESULTS: Median time from last exposure to symptom onset (incubation period) among cases that did not receive PEP(L) was 7 days (range 1-16). Time to PEP(L) receipt was 7 days (range 0-14). Among 549 individuals, adjusted PEP(L) and PEP(F) effectiveness was 19 % (95 % Confidence Interval [CI], -54 % to 57 %) and -7% (95 % CI, -144 % to 53 %) using the target trial emulation, respectively, and 78 % (95 % CI, 50 % to 91 %) and 73 % (95 % CI, 31 % to 91 %) using conventional analysis. CONCLUSIONS: Determining PEP effectiveness using real-world data during an outbreak is challenging. Time to PEP in NYC coupled with the observed incubation period resulted in overestimated PEP effectiveness using a conventional method. The target trial emulation, while yielding wide confidence intervals due to small sample size, avoided immortal time bias. While results from these evaluations cannot be used as reliable estimates of PEP effectiveness, we present important methodologic considerations for future evaluations. |
Estimation of mortality rate ratios for chronic conditions with misclassification of disease status at death
Voß S , Hoyer A , Landwehr S , Pavkov ME , Gregg E , Brinks R . BMC Med Res Methodol 2024 24 (1) 2 Estimation of mortality rates and mortality rate ratios (MRR) of diseased and non-diseased individuals is a core metric of disease impact used in chronic disease epidemiology. Estimation of mortality rates is often conducted through retrospective linkage of information from nationwide surveys such as the National Health Interview Survey (NHIS) and death registries. These surveys usually collect information on disease status during only one study visit. This infrequency leads to missing disease information (with right censored survival times) for deceased individuals who were disease-free at study participation, and a possibly biased estimation of the MRR because of possible undetected disease onset after study participation. This occurrence is called "misclassification of disease status at death (MicDaD)" and it is a potentially common source of bias in epidemiologic studies. In this study, we conducted a simulation analysis with a high and a low incidence setting to assess the extent of MicDaD-bias in the estimated mortality. For the simulated populations, MRR for diseased and non-diseased individuals with and without MicDaD were calculated and compared. Magnitude of MicDaD-bias depends on and is driven by the incidence of the chronic disease under consideration; our analysis revealed a noticeable shift towards underestimation for high incidences when MicDaD is present. Impact of MicDaD was smaller for lower incidence (but associated with greater uncertainty in the estimation of MRR in general). Further research can consider the amount of missing information and potential influencers such as duration and risk factors of the disease. |
Vitamin B12 supplementation during pregnancy for maternal and child health outcomes
Finkelstein JL , Fothergill A , Venkatramanan S , Layden AJ , Williams JL , Crider KS , Qi YP . Cochrane Database Syst Rev 2024 1 (1) Cd013823 BACKGROUND: Vitamin B(12) deficiency is a major public health problem worldwide, with the highest burden in elderly people, pregnant women, and young children. Due to its role in DNA synthesis and methylation, folate metabolism, and erythropoiesis, vitamin B(12) supplementation during pregnancy may confer longer-term benefits to maternal and child health outcomes. OBJECTIVES: To evaluate the benefits and harms of oral vitamin B(12) supplementation during pregnancy on maternal and child health outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP) on 2 June 2023, and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs), quasi-RCTs, or cluster-RCTs evaluating the effects of oral vitamin B(12) supplementation compared to placebo or no vitamin B(12) supplementation during pregnancy. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Four review authors independently assessed trial eligibility. Two review authors independently extracted data from included studies and conducted checks for accuracy. Three review authors independently assessed the risk of bias of the included studies using the Cochrane RoB 1 tool. We used GRADE to evaluate the certainty of evidence for primary outcomes. MAIN RESULTS: The review included five trials with 984 pregnant women. All trials were conducted in low- and middle-income countries, including India, Bangladesh, South Africa, and Croatia. At enrolment, 26% to 51% of pregnant women had vitamin B(12) deficiency (less than 150 pmol/L), and the prevalence of anaemia (haemoglobin less than 11.0 g/dL) ranged from 30% to 46%. The dosage of vitamin B(12) supplementation varied from 5 μg/day to 250 μg/day, with administration beginning at 8 to 28 weeks' gestation through to delivery or three months' postpartum, and the duration of supplementation ranged from 8 to 16 weeks to 32 to 38 weeks. Three trials, involving 609 pregnant women, contributed data for meta-analyses of the effects of vitamin B(12) supplementation compared to placebo or no vitamin B(12) supplementation. Maternal anaemia: there may be little to no difference for maternal anaemia by intervention group, but the evidence is very uncertain (70.9% versus 65.0%; risk ratio (RR) 1.08, 95% confidence interval (CI) 0.93 to 1.26; 2 trials, 284 women; very low-certainty evidence). Maternal vitamin B(12) status: vitamin B(12) supplementation during pregnancy may reduce the risk of maternal vitamin B(12) deficiency compared to placebo or no vitamin B(12) supplementation, but the evidence is very uncertain (25.9% versus 67.9%; RR 0.38, 95% CI 0.28 to 0.51; 2 trials, 272 women; very low-certainty evidence). Women who received vitamin B(12) supplements during pregnancy may have higher total vitamin B(12) concentrations compared to placebo or no vitamin B(12) supplementation (mean difference (MD) 60.89 pmol/L, 95% CI 40.86 to 80.92; 3 trials, 412 women). However, there was substantial heterogeneity (I(2) = 85%). Adverse pregnancy outcomes: the evidence is uncertain about the effect on adverse pregnancy outcomes, including preterm birth (RR 0.97, 95% CI 0.55 to 1.74; 2 trials, 340 women; low-certainty evidence), and low birthweight (RR 1.50, 95% CI 0.93 to 2.43; 2 trials, 344 women; low-certainty evidence). Two trials reported data on spontaneous abortion (or miscarriage); however, the trials did not report quantitative data for meta-analysis and there was no clear definition of spontaneous abortion in the study reports. No trials evaluated the effects of vitamin B(12) supplementation during pregnancy on neural tube defects. Infant vitamin B(12) status: children born to women who received vitamin B(12) supplementation had higher total vitamin B(12) concentrations compared to placebo or no vitamin B(12) supplementation (MD 71.89 pmol/L, 95% CI 20.23 to 123.54; 2 trials, 144 children). Child cognitive outcomes: three ancillary analyses of one trial reported child cognitive outcomes; however, data were not reported in a format that could be included in quantitative meta-analyses. In one study, maternal vitamin B(12) supplementation did not improve neurodevelopment status (e.g. cognitive, language (receptive and expressive), motor (fine and gross), social-emotional, or adaptive (conceptual, social, practical) domains) in children compared to placebo (9 months, Bayley Scales of Infant and Toddler Development Third Edition (BSID-III); 1 trial; low-certainty evidence) or neurophysiological outcomes (72 months, event-related potential measures; 1 trial; low-certainty evidence), though children born to women who received vitamin B(12) supplementation had improved expressive language domain compared to placebo (30 months, BSID-III; 1 trial; low-certainty evidence). AUTHORS' CONCLUSIONS: Oral vitamin B(12) supplementation during pregnancy may reduce the risk of maternal vitamin B(12) deficiency and may improve maternal vitamin B(12) concentrations during pregnancy or postpartum compared to placebo or no vitamin B(12) supplementation, but the evidence is very uncertain. The effects of vitamin B(12) supplementation on other primary outcomes assessed in this review were not reported, or were not reported in a format for inclusion in quantitative analyses. Vitamin B(12) supplementation during pregnancy may improve maternal and infant vitamin B(12) status, but the potential impact on longer-term clinical and functional maternal and child health outcomes has not yet been established. |
Multiple imputation of missing race/ethnicity information in the National Assisted Reproductive Technology Surveillance System
Zhang Y , Kissin DM , Liao KJ , DeSantis CE , Yartel AK , Gutman R . J Womens Health (Larchmt) 2023 Background: Missing race/ethnicity data are common in many surveillance systems and registries, which may limit complete and accurate assessments of racial and ethnic disparities. Centers for Disease Control and Prevention's National Assisted Reproductive Technology (ART) Surveillance System (NASS) has a congressional mandate to collect data on all ART cycles performed by fertility clinics in the United States and provides valuable information on ART utilization and treatment outcomes. However, race/ethnicity data are missing for many ART cycles in NASS. Materials and Methods: We multiply imputed missing race/ethnicity data using variables from NASS and additional zip code-level race/ethnicity information in U.S. Census data. To evaluate imputed data quality, we generated training data by imposing missing values on known race/ethnicity under missing at random assumption, imputed, and examined the relationship between race/ethnicity and the rate of stillbirth per pregnancy. Results: The distribution of imputed race/ethnicity was comparable to the reported one with the largest difference of 0.53% for non-Hispanic Asian. Our imputation procedure was well calibrated and correctly identified that 89.91% (standard error = 0.18) of known race/ethnicity values on average in training data. Compared to complete-case analysis, using multiply imputed data reduced bias of parameter estimates (the range of bias for stillbirth per pregnancy across race/ethnicity groups is 0.02%-0.18% for imputed data analysis, versus 0.04%-0.66% for complete-case analysis) and yielded narrower confidence intervals. Conclusions: Our results underscore the importance of collecting complete race/ethnicity information for ART surveillance. However, when the missingness exists, multiply imputed race/ethnicity can improve the accuracy and precision of health outcomes estimated across racial/ethnic groups. |
Bias analyses to investigate the impact of differential participation: Application to a birth defects case-control study
Petersen JM , Kahrs JC , Adrien N , Wood ME , Olshan AF , Smith LH , Howley MM , Ailes EC , Romitti PA , Herring AH , Parker SE , Shaw GM , Politis MD . Paediatr Perinat Epidemiol 2023 BACKGROUND: Certain associations observed in the National Birth Defects Prevention Study (NBDPS) contrasted with other research or were from areas with mixed findings, including no decrease in odds of spina bifida with periconceptional folic acid supplementation, moderately increased cleft palate odds with ondansetron use and reduced hypospadias odds with maternal smoking. OBJECTIVES: To investigate the plausibility and extent of differential participation to produce effect estimates observed in NBDPS. METHODS: We searched the literature for factors related to these exposures and participation and conducted deterministic quantitative bias analyses. We estimated case-control participation and expected exposure prevalence based on internal and external reports, respectively. For the folic acid-spina bifida and ondansetron-cleft palate analyses, we hypothesized the true odds ratio (OR) based on prior studies and quantified the degree of exposure over- (or under-) representation to produce the crude OR (cOR) in NBDPS. For the smoking-hypospadias analysis, we estimated the extent of selection bias needed to nullify the association as well as the maximum potential harmful OR. RESULTS: Under our assumptions (participation, exposure prevalence, true OR), there was overrepresentation of folic acid use and underrepresentation of ondansetron use and smoking among participants. Folic acid-exposed spina bifida cases would need to have been ≥1.2× more likely to participate than exposed controls to yield the observed null cOR. Ondansetron-exposed cleft palate cases would need to have been 1.6× more likely to participate than exposed controls if the true OR is null. Smoking-exposed hypospadias cases would need to have been ≥1.2 times less likely to participate than exposed controls for the association to falsely appear protective (upper bound of selection bias adjusted smoking-hypospadias OR = 2.02). CONCLUSIONS: Differential participation could partly explain certain associations observed in NBDPS, but questions remain about why. Potential impacts of other systematic errors (e.g. exposure misclassification) could be informed by additional research. |
Physical job demands in pregnancy and associated musculoskeletal health and employment outcomes: a systematic review
Macdonald LA , Johnson CY , Ming-Lun LU , Santiago-Colón A , Adam MGP , Kimmel MHJ , Napolitano PG , Saldanha IJ . Am J Obstet Gynecol 2023 OBJECTIVE: A decline in musculoskeletal health during pregnancy is an under-appreciated adverse outcome of pregnancy that can have immediate and long-term health consequences. High physical job demands are known risk factors for non-traumatic musculoskeletal disorders in the general working population. Evidence from meta-analyses suggest occupational lifting and prolonged standing during pregnancy may increase risk of adverse pregnancy outcomes. This systematic review examined associations between occupational lifting or postural load in pregnancy and associated musculoskeletal disorders and related sequalae. DATA SOURCES: Five electronic databases (Medline, Embase, CINAHL, NIOSHTIC-2 and Ergonomic Abstracts) were searched from 1990 to July 2022 for studies in any language. A Web of Science snowball search was performed in December 2022. Reference lists were manually reviewed. ELIGIBILITY CRITERIA: Eligible studies reported associations between occupational lifting or postural load and musculoskeletal health or sequelae (e.g., employment outcomes) among pregnant and postpartum workers. METHODS: Data were extracted using a customized form to document study and sample characteristics, and details of exposures, outcomes, covariates, and analyses. Investigators independently assessed study quality for seven risk of bias domains and overall utility, with discrepant ratings resolved through discussion. A narrative synthesis was conducted due to heterogeneity. RESULTS: Sixteen studies (11 cohort studies, 2 nested case-control studies, and 3 cross-sectional studies) from 8 countries were included (N=142,320 pregnant and N=1,744 postpartum workers). Limited but consistent evidence with variable quality ratings, ranging from critical concern to high, suggests that pregnant workers exposed to heavy lifting (usually defined as ≥22 lbs or ≥10 kg) may be at increased risk of functionally limiting pelvic girdle pain and antenatal leave. Moreover, reports of dose-response relationships suggest graded risk levels according to lifting frequency, ranging from 21% to 45% for pelvic girdle pain and 58% to 202% for antenatal leave. Limited but consistent evidence also suggests that postural load increases the risk of employment cessation. CONCLUSION: Limited but consistent evidence suggests that pregnant workers exposed to heavy lifting and postural load are at increased risk of pelvic girdle pain and employment cessation. Job accommodations to reduce exposure levels may promote safe sustainable employment for pregnant workers. |
Reducing malaria transmission through reactive indoor residual spraying: A systematic review
Gimnig JE , Steinhardt LC , Awolola TS , Impoinvil D , Zohdy S , Lindblade KA . Am J Trop Med Hyg 2023 In the final stages of malaria elimination, interventions to reduce malaria transmission are often centered around a confirmed case of malaria, as cases tend to cluster together at very low levels of transmission. The WHO commissioned a systematic review of the literature and synthesis of evidence for reactive indoor residual spraying (IRS) to develop official recommendations for countries. Several electronic databases were searched in November 2020. A total of 455 records were identified and screened; 20 full-text articles were assessed for eligibility. Two cluster-randomized trials met the inclusion criteria for epidemiological outcomes. Risk of bias was assessed using standard criteria. Because one study was a superiority trial in which the comparator included reactive case detection or mass drug administration and the other was a noninferiority trial in which the comparator was proactive, focal IRS, results could not be pooled. In the superiority trial, reactive IRS reduced malaria prevalence by 68% (risk ratio [RR]: 0.32; 95% CI: 0.13-0.80; certainty of evidence: HIGH) compared with no reactive IRS. No difference was observed for clinical malaria (RR: 0.65; 95% CI: 0.38-1.11; certainty of evidence: MODERATE). In the noninferiority study, the mean difference in incidence between reactive IRS and proactive IRS was 0.10 additional case per 1,000 person-years, which was within the prespecified noninferiority bound (95% CI: -0.38 to 0.58; certainty of evidence: MODERATE). The evidence indicates that reactive IRS may be a cost-effective tool for the prevention of malaria in elimination settings. As only two cluster-randomized controlled trials from sub-Saharan Africa were found, additional high-quality studies should be encouraged. |
Post-discharge malaria chemoprevention in children admitted with severe anaemia in malaria-endemic settings in Africa: a systematic review and individual patient data meta-analysis of randomised controlled trials
Phiri KS , Khairallah C , Kwambai TK , Bojang K , Dhabangi A , Opoka R , Idro R , Stepniewska K , van Hensbroek MB , John CC , Robberstad B , Greenwood B , Kuile FOT . Lancet Glob Health 2024 12 (1) e33-e44 BACKGROUND: Severe anaemia is associated with high in-hospital mortality among young children. In malaria-endemic areas, surviving children also have an increased risk of mortality or readmission after hospital discharge. We conducted a systematic review and individual patient data meta-analysis to determine the efficacy of monthly post-discharge malaria chemoprevention in children recovering from severe anaemia. METHODS: This analysis was conducted according to PRISMA-IPD guidelines. We searched multiple databases on Aug 28, 2023, without date or language restrictions, for randomised controlled trials comparing monthly post-discharge malaria chemoprevention with placebo or standard of care among children (aged <15 years) admitted with severe anaemia in malaria-endemic Africa. Trials using daily or weekly malaria prophylaxis were not eligible. The investigators from all eligible trials shared pseudonymised datasets, which were standardised and merged for analysis. The primary outcome was all-cause mortality during the intervention period. Analyses were performed in the modified intention-to-treat population, including all randomly assigned participants who contributed to the endpoint. Fixed-effects two-stage meta-analysis of risk ratios (RRs) was used to generate pooled effect estimates for mortality. Recurrent time-to-event data (readmissions or clinic visits) were analysed using one-stage mixed-effects Prentice-Williams-Peterson total-time models to obtain hazard ratios (HRs). This study is registered with PROSPERO, CRD42022308791. FINDINGS: Our search identified 91 articles, of which 78 were excluded by title and abstract, and a further ten did not meet eligibility criteria. Three double-blind, placebo-controlled trials, including 3663 children with severe anaemia, were included in the systematic review and meta-analysis; 3507 (95·7%) contributed to the modified intention-to-treat analysis. Participants received monthly sulfadoxine-pyrimethamine until the end of the malaria transmission season (mean 3·1 courses per child [range 1-6]; n=1085; The Gambia), monthly artemether-lumefantrine given at the end of weeks 4 and 8 post discharge (n=1373; Malawi), or monthly dihydroartemisinin-piperaquine given at the end of weeks 2, 6, and 10 post discharge (n=1049; Uganda and Kenya). During the intervention period, post-discharge malaria chemoprevention was associated with a 77% reduction in mortality (RR 0·23 [95% CI 0·08-0·70], p=0·0094, I(2)=0%) and a 55% reduction in all-cause readmissions (HR 0·45 [95% CI 0·36-0·56], p<0·0001) compared with placebo. The protective effect was restricted to the intervention period and was not sustained after the direct pharmacodynamic effect of the drugs had waned. The small number of trials limited our ability to assess heterogeneity, its sources, and publication bias. INTERPRETATION: In malaria-endemic Africa, post-discharge malaria chemoprevention reduces mortality and readmissions in recently discharged children recovering from severe anaemia. Post-discharge malaria chemoprevention could be a valuable strategy for the management of this group at high risk. Future research should focus on methods of delivery, options to prolong the protection duration, other hospitalised groups at high risk, and interventions targeting non-malarial causes of post-discharge morbidity. FUNDING: The Research-Council of Norway and the Bill-&-Melinda-Gates-Foundation through the Worldwide-Antimalarial-Research-Network. |
Epigenome-wide association studies of prenatal maternal mental health and infant epigenetic profiles: a systematic review
Drzymalla E , Crider KS , Wang A , Marta G , Khoury MJ , Rasooly D . Transl Psychiatry 2023 13 (1) 377 Prenatal stress and poor maternal mental health are associated with adverse offspring outcomes; however, the biological mechanisms are unknown. Epigenetic modification has linked maternal health with offspring development. Epigenome-wide association studies (EWAS) have examined offspring DNA methylation profiles for association with prenatal maternal mental health to elucidate mechanisms of these complex relationships. The objective of this study is to provide a comprehensive, systematic review of EWASs of infant epigenetic profiles and prenatal maternal anxiety, depression, or depression treatment. We conducted a systematic literature search following PRISMA guidelines for EWAS studies between prenatal maternal mental health and infant epigenetics through May 22, 2023. Of 645 identified articles, 20 fulfilled inclusion criteria. We assessed replication of CpG sites among studies, conducted gene enrichment analysis, and evaluated the articles for quality and risk of bias. We found one repeated CpG site among the maternal depression studies; however, nine pairs of overlapping differentially methylatd regions were reported in at least two maternal depression studies. Gene enrichment analysis found significant pathways for maternal depression but not for any other maternal mental health category. We found evidence that these EWAS present a medium to high risk of bias. Exposure to prenatal maternal depression and anxiety or treatment for such was not consistently associated with epigenetic changes in infants in this systematic review and meta-analysis. Small sample size, potential bias due to exposure misclassification and statistical challenges are critical to address in future efforts to explore epigenetic modification as a potential mechanism by which prenatal exposure to maternal mental health disorders leads to adverse infant outcomes. |
Race, ethnicity, and immune tolerance induction in hemophilia A in the United States
Kempton CL , Payne AB , Fedewa SA . Res Pract Thromb Haemost 2023 7 (8) 102251 Background: In racially diverse communities, treatment of chronic diseases can vary across racial and ethnic groups. Objectives: To examine healthcare disparities in hemophilia care in the United States by evaluating receipt of immune tolerance induction (ITI) among different racial and ethnic groups. Methods: In this cross-sectional study, people with severe hemophilia A with an inhibitor who entered the Center for Disease Control and Prevention Community Counts registry between 2013 and 2017, were aged ≥5 years at study entry, and had a history of an inhibitor (n = 614) were included. The proportion of participants receiving ITI was examined according to race and ethnicity in bivariable analysis and multivariable analysis adjusting for demographic and clinical covariates. Unadjusted and adjusted prevalence ratios and corresponding 95% CIs were computed. Results: Among 614 participants included in the study, 56.4% were non-Hispanic (NH) White, 19.7% were NH Black, 18.4% were Hispanic, and 4.9% were Asian. ITI was received by 85.2% of participants. On bivariable analysis, ITI treatment did not vary by race or ethnicity. On multivariable analysis, NH Black and Hispanic participants were significantly less likely to receive ITI compared to NH White participants (adjusted prevalence ratio, 0.91 [95% CI, 0.84-0.99] and 0.84 [95% CI, 0.75-0.93], respectively). Conclusion: Although the role of ITI may evolve with growing use of emicizumab and the introduction of new hemophilia treatment products, understanding characteristics that influence care, particularly race and ethnicity, where physician bias and patient mistrust can occur, will remain relevant and applicable to other complex therapies, including gene therapy. © 2023 |
Associations of diabetes, hypertension and obesity with COVID-19 mortality: a systematic review and meta-analysis
Li C , Islam N , Gutierrez JP , Gutiérrez-Barreto SE , Prado AC , Moolenaar RL , Lacey B , Richter P . BMJ Glob Health 2023 8 (12) e012581 Introduction Despite a growing body of scholarly research on the risks of severe COVID-19 associated with diabetes, hypertension and obesity, there is a need for estimating pooled risk estimates with adjustment for confounding effects. We conducted a systematic review and meta-analysis to estimate the pooled adjusted risk ratios of diabetes, hypertension and obesity on COVID-19 mortality.Methods We searched 16 literature databases for original studies published between 1 December 2019 and 31 December 2020. We used the adapted Newcastle-Ottawa Scale to assess the risk of bias. Pooled risk ratios were estimated based on the adjusted effect sizes. We applied random-effects meta-analysis to account for the uncertainty in residual heterogeneity. We used contour-funnel plots and Egger’s test to assess possible publication bias.Results We reviewed 34 830 records identified in literature search, of which 145 original studies were included in the meta-analysis. Pooled adjusted risk ratios were 1.43 (95% CI 1.32 to 1.54), 1.19 (95% CI 1.09 to 1.30) and 1.39 (95% CI 1.27 to 1.52) for diabetes, hypertension and obesity (body mass index ≥30 kg/m2) on COVID-19 mortality, respectively. The pooled adjusted risk ratios appeared to be stronger in studies conducted before April 2020, Western Pacific Region, low- and middle-income countries, and countries with low Global Health Security Index scores, when compared with their counterparts.Conclusions Diabetes, hypertension and obesity were associated with an increased risk of COVID-19 mortality independent of other known risk factors, particularly in low-resource settings. Addressing these chronic diseases could be important for global pandemic preparedness and mortality prevention.PROSPERO registration number CRD42021204371.Data are available in a public, open access repository. Not applicable. |
Decrypting seasonal patterns of key pollen taxa in cool temperate Australia: A multi-barcode metabarcoding analysis
Tegart LJ , Gabriele S , Dickinson JL , Green BJ , Barberán A , Marthick JR , Bissett A , Johnston FH , Jones PJ . Environ Res 2023 243 117808 Pollen allergies pose a considerable global public health concern. Allergy risk can vary significantly within plant families, yet some key pollen allergens can only be identified to family level by current optical methods. Pollen information with greater taxonomic resolution is therefore required to best support allergy prevention and self-management. We used environmental DNA (eDNA) metabarcoding to deepen taxonomic insights into the seasonal composition of airborne pollen in cool temperate Australia, a region with high rates of allergic respiratory disease. In Hobart, Tasmania, we collected routine weekly air samples from December 2018 until October 2020 and sequenced the internal transcribed spacer 2 (ITS2) and chloroplastic tRNA-Leucine tRNA-Phenylalanine intergenic spacer (trnL-trnF) regions in order to address the following questions: a) What is the genus-level diversity of known and potential aeroallergens in Hobart, in particular, in the families Poaceae, Cupressaceae and Myrtaceae? b) How do the atmospheric concentrations of these taxa change over time, and c) Does trnL-trnF enhance resolution of biodiversity when used in addition to ITS2? Our results suggest that individuals in the region are exposed to temperate grasses including Poa and Bromus in the peak grass pollen season, however low levels of exposure to the subtropical grass Cynodon may occur in autumn and winter. Within Cupressaceae, both metabarcodes showed that exposure is predominantly to pollen from the introduced genera Cupressus and Juniperus. Only ITS2 detected the native genus, Callitris. Both metabarcodes detected Eucalyptus as the major Myrtaceae genus, with trnL-trnF exhibiting primer bias for this family. These findings help refine our understanding of allergy triggers in Tasmania and highlight the utility of multiple metabarcodes in aerobiome studies. |
Impact of accounting for correlation between COVID-19 and influenza vaccination in a COVID-19 vaccine effectiveness evaluation using a test-negative design
Payne AB , Ciesla AA , Rowley EAK , Weber ZA , Reese SE , Ong TC , Vazquez-Benitez G , Naleway AL , Klein NP , Embi PJ , Grannis SJ , Kharbanda AB , Gaglani M , Tenforde MW , Link-Gelles R . Vaccine 2023 41 (51) 7581-7586 Test-negative-design COVID-19 vaccine effectiveness (VE) studies use symptomatic SARS-CoV-2-positive individuals as cases and symptomatic SARS-CoV-2-negative individuals as controls to evaluate COVID-19 VE. To evaluate the potential bias introduced by the correlation of COVID-19 and influenza vaccination behaviors, we assessed changes in estimates of VE of bivalent vaccines against COVID-19-associated hospitalizations and emergency department/urgent care (ED/UC) encounters when considering influenza vaccination status or including or excluding influenza-positive controls using data from the multi-state VISION vaccine effectiveness network. Analyses included encounters during October 2022 - February 2023, a period of SARS-CoV-2 and influenza cocirculation. When considering influenza vaccination status or including or excluding influenza-positive controls, COVID-19 VE estimates were robust, with most VE estimates against COVID-19-associated hospitalization and ED/UC encounters changing less than 5 percentage points. Higher proportions of influenza-positive patients among controls, influenza vaccination coverage, or VE could impact these findings; the potential bias should continue to be assessed. |
US trends in maternal mortality by racial and ethnic group
Rossen LM , Hoyert D , Branum AM . JAMA 2023 330 (18) 1799-1800 A recent article1 described increases in MMRs from 1999 to 2019, racial and ethnic disparities, and differences by US state. The use of bayesian models to provide more precise estimates of MMRs for small racial and ethnic subgroups is a strength, but not a panacea for the problem of small numbers. The utility of state-level estimates by subgroup is questionable when driven mainly by the priors and associated with wide uncertainty intervals, a concern for subgroups with fewer than 20 events each year. Additionally, failure to account for differential adoption of the pregnancy checkbox by US states over time biased the trend estimates and resulting conclusions of this study.1 | | The study authors acknowledged in the Discussion section that “it is possible that some of the increases in maternal mortality over time are due to an increasing number of states incorporating the pregnancy checkbox….”1 However, it is insufficient to simply note the effect of the pregnancy checkbox as a limitation, given numerous prior studies describing trends in maternal mortality in the context of changes in ascertainment. These studies have quantified the effect of the incremental adoption of the pregnancy checkbox on the standard certificate of death (which occurred from 2003 to 2017), showing that observed increases in MMRs from the early 2000s to 2017 are entirely or nearly entirely an artifact of changes in measurement over time, with no significant trends in MMRs once the checkbox was accounted for.2-4 It is highly likely that the increases reported in this study1 were an artifact of changes in ascertainment. | | Estimated racial and ethnic disparities in MMR trends are also subject to bias due to the incremental adoption of the checkbox by states over time, given the geographic concentration of specific subpopulations such as non-Hispanic American Indian or Alaska Native persons. The effect of checkbox implementation varies by age, race and ethnicity, state, and cause of death, with larger effects seen among people aged 35 years or older, among non-Hispanic Black individuals, and for nonspecific maternal causes of death.2-4 Consequently, it is important to explicitly account for the effect of the pregnancy checkbox and other changes in measurement5 over time when estimating trends and racial and ethnic disparities in MMRs as well as state-level patterns. Without accurate and comparable measurement of MMR trends and disparities, conclusions cannot be drawn about the effect of prevention efforts. |
Challenges and opportunities to care for children in child welfare with fetal alcohol spectrum disorders while working toward preserving their families
Richards Tammy , Miller Nicole , Eaton Elizabeth , Newburg-Rinn Sharon , Bertrand Jacquelyn . Child Welfare 2023 101 (3) 209-234 The article describes the challenges for child welfare professionals in meeting goals in work with children prenatally exposed to alcohol and their families, as well as ways to address those challenges. Topics include the use and misuse of information on children's prenatal exposure to alcohol, the use of information on a child's prenatal exposure to alcohol to label children as at high risk for future maltreatment, and the need for training to inform service delivery and reduce bias. |
Increasing access to quality care for pregnant and postpartum people with opioid use disorder: Coordination of services, provider awareness and training, extended postpartum coverage, and perinatal quality collaboratives
Ellick KL , Kroelinger CD , Chang K , McGown M , McReynolds M , Velonis AJ , Bronson E , Riehle-Colarusso T , Pliska E , Akbarali S , Mueller T , Dronamraju R , Cox S , Barfield WD . J Subst Use Addict Treat 2023 156 209208 INTRODUCTION: Fifteen states participating in the Opioid Use Disorder, Maternal Outcomes, and Neonatal Abstinence Syndrome Initiative Learning Community (OMNI LC) developed action plan goals and activities to address the rise in opioid use disorder (OUD) among birthing persons. In a separate initiative, Perinatal Quality Collaboratives (PQCs) from 12 states participating in Centers for Disease Control and Prevention (CDC)-supported activities hosted trainings to improve the provision of OUD services and implement protocols for screening and treatment in delivery facilities. METHODS: This descriptive study synthesizes qualitative data extracted from 15 OMNI LC state action plans, excerpts from qualitative interviews conducted with OMNI LC state teams, and quantitative data from quarterly project performance monitoring reports from 12 CDC-funded PQCs implementing quality improvement activities to address clinical service gaps for pregnant and postpartum people with OUD. Qualitative data were deidentified, coded as barriers or facilitators, then aggregated into emergent themes. Count data are presented for quantitative results. RESULTS: The OMNI LC states identified a lack of coordinated care among providers, stigma toward people with OUD, discontinued insurance coverage, and inconsistencies in screening and treating birthing people with OUD as barriers to accessing quality care. Facilitators for access to quality care states identified included: 1) improving engagement and communication between providers and other partners to integrate medical and behavioral health services post-discharge, and facilitate improved patient care postpartum; 2) training providers to prescribe medications for OUD, and to address bias and reduce patient stigma; 3) extending Medicaid coverage up to one year postpartum to increase access to and continuity of services; and 4) implementing screening, brief intervention, and referral to treatment (SBIRT) in clinical practice. PQCs demonstrated that increased provider trainings to treat OUD, improvements in implementation of standardized protocols, and use of evidence-based tools can facilitate access to and coordination of services in delivery facilities. CONCLUSION: State-identified facilitators for increasing access to care include coordinating integrated services, extending postpartum coverage, and provider trainings to improve screening and treatment. PQCs provide a platform for identifying emerging areas for quality improvement initiatives and implementing clinical best practices to provide comprehensive, quality perinatal care for birthing populations. |
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