Category: Statistics

Langmuir. 2026 May 4. doi: 10.1021/acs.langmuir.6c00298. Online ahead of print.

ABSTRACT

Monodisperse microbubbles (MDMBs) fabricated by microfluidics exhibit a narrow size distribution and uniform acoustic response, making them promising for ultrasound imaging and therapy. However, significantly high lipid concentrations were inevitably required to inhibit bubble coalescence during high-production-rate fabrication of lipid-coated MDMBs with a low polydispersity index (PDI), leading to substantial waste and poor cost-effectiveness. Therefore, under low lipid concentrations, minimizing bubble coalescence during high-production-rate MDMB fabrication and enabling fine-tuning of acoustic properties are crucial for advancing medical applications of MDMBs. We used a flow-focusing microfluidic chip to fabricate MDMBs under varied lipid concentrations, surfactant Tween 20 concentrations, and production rates. The coalescence rate of initially formed bubbles at the chip’s orifice and outlet was statistically analyzed from high-speed photographic images. Tween 20 effectively prevented bubble coalescence under low lipid concentrations during high-production-rate MDMB fabrication, yielding a low PDI. An increased contraction ratio of MDMBs at a higher Tween-20-to-lipid ratio indicated that the incorporation of Tween 20’s alkyl chains into the lipid monolayer enhanced steric repulsion, thereby preventing bubble proximity and coalescence. After a 2-day stabilization of the freshly collected MDMBs, the acoustic attenuation spectra and cavitation dynamics were accurately characterized. Statistical results revealed that both shell elasticity and cavitation stability of MDMBs significantly increased with higher Tween 20 concentration, but significantly decreased with elevated lipid concentration, thereby enabling their precise tuning via the Tween-20-to-lipid ratio. These findings establish a feasible approach for fabricating, under low lipid concentrations, high-production-rate lipid-coated MDMBs with low PDI and tunable acoustic properties, thus advancing ultrasound-based medical applications.

PMID:42081263 | DOI:10.1021/acs.langmuir.6c00298

J Dev Behav Pediatr. 2026 May 1. doi: 10.1097/DBP.0000000000001486. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to assess EI referral and enrollment rates among substance-exposed newborns (SENs) with and without a diagnosis of NAS in MA and to compare rates to infants and toddlers without known substance exposure.

METHODS: We analyzed the 2013-2020 Pregnancy to Early Life Longitudinal dataset, which includes maternal-infant birth hospitalization records linked with EI data. SEN and NAS were identified using ICD-9/10 codes. We conducted descriptive statistics and bivariate analysis to compare EI referral and enrollment between (1) SENs with and without NAS diagnoses and (2) SENs and the unexposed population.

RESULTS: Among 6565 SENs, 85.3% (n = 5602) were referred to EI, and of those referred, 49.5% (n = 2775) enrolled. Compared with SENs without an NAS diagnosis, SENs with an NAS diagnosis were more likely to be referred to (87.6%, n = 4242 vs 79.0%, n = 1360) and enroll in (53.2%, n = 2255 vs 38.2%, n = 520) EI. Among infants and toddlers without identified substance exposure, referral rates were lower (34.6%), but enrollment rates were higher among those referred (56.7%).

CONCLUSION: Substance-exposed newborns in MA had relatively high rates of EI referral but lower rates of enrollment compared with the general population, particularly among SENs without a diagnosis of NAS, suggesting a referral-to-enrollment gap.

PMID:42081262 | DOI:10.1097/DBP.0000000000001486

JAMA Netw Open. 2026 May 1;9(5):e2610120. doi: 10.1001/jamanetworkopen.2026.10120.

ABSTRACT

IMPORTANCE: In the US, adjuvanted or higher-dose influenza vaccines are preferentially recommended for annual use among adults aged 65 years or older. Adjuvanted and high-dose influenza vaccines have not been compared in a pragmatic randomized study.

OBJECTIVE: To assess the relative vaccine effectiveness (rVE) of adjuvanted vs high-dose inactivated influenza vaccine against polymerase chain reaction (PCR)-confirmed influenza in older adults at Kaiser Permanente Northern California (KPNC).

DESIGN, SETTING, AND PARTICIPANTS: In this cluster randomized crossover study, during the 2023 to 2024 influenza season, 65 KPNC facilities were cluster randomized such that approximately half of facilities administered adjuvanted and half high-dose influenza vaccine on the first week of the vaccination season (and thereafter every facility crossed over and alternated formulations weekly). Using Cox proportional hazards regression on a calendar time scale, the rVE of adjuvanted vs high-dose vaccine was estimated for each outcome as 1 minus the hazard ratio, adjusted for age, sex, race and ethnicity, comorbidities, and health care utilization. Study participants included all adults 65 years or older who were vaccinated with adjuvanted or high-dose inactivated influenza vaccine during routine care at a KPNC facility between August 17, 2023, and April 16, 2024.

EXPOSURES: Adjuvanted or high-dose inactivated influenza vaccine receipt during the 2023 to 2024 influenza season. Individuals were considered vaccinated 14 days after immunization.

MAIN OUTCOMES AND MEASURES: The primary outcome was PCR-confirmed influenza in any clinical setting. Secondary outcomes were PCR-confirmed influenza with hospitalization or emergency department visits and hospitalization for community-acquired pneumonia. Outcomes were assessed starting October 1, 2023, or 14 days after vaccination, whichever came later.

RESULTS: This study included 429 595 individuals from the 2023 to 2024 influenza season (mean [SD] age, 75 [7] years; 236 857 [55.1%] female; 86 287 [20.1%] Asian, 22 910 [5.3%] Black, 53 820 [12.5%] Hispanic, 1123 [0.3%] American Indian or Alaska Native, 2562 [0.6%] Pacific Islander, 252 709 [58.8%] White, 1638 [0.4%] multiracial, and 8546 [2.0%] unknown race), of whom 212 875 (49.6%) received adjuvanted and 216 720 (50.4%) received high-dose influenza vaccine. There were 836 cases of PCR-confirmed influenza (3.9 per 1000 persons) identified after adjuvanted and 867 cases (4.0 per 1000 persons) after high-dose vaccine. The rVE of adjuvanted compared with high-dose influenza vaccine was 1.5% (95% CI, -8.4% to 10.5%) against influenza, 9.1% (95% CI, -4.0% to 20.4%) against influenza with hospitalization or emergency department visits, and 1.0% (95% CI, -11.4% to 12.0%) against hospitalizations for community-acquired pneumonia.

CONCLUSION AND RELEVANCE: In the first season of a large, ongoing study in adults 65 years or older, adjuvanted and high-dose influenza vaccines did not differ in effectiveness against laboratory-confirmed influenza during the 2023 to 2024 influenza season. Consistent with Advisory Committee on Immunization Practices recommendations, these results support the equivalency of adjuvanted and high-dose influenza vaccines for adults 65 years or older.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06029933.

PMID:42081247 | DOI:10.1001/jamanetworkopen.2026.10120

JAMA Netw Open. 2026 May 1;9(5):e2610321. doi: 10.1001/jamanetworkopen.2026.10321.

ABSTRACT

IMPORTANCE: Children with medical complexity often require complicated home care regimens, yet health care safety issues in community settings have been rarely described. Systems-level approaches to addressing patient safety in pediatric home health care (HHC) also remain nascent. Quantifying and categorizing HHC staff incidents is a first step toward preventing the occurrence of safety events in this population.

OBJECTIVE: To identify the rates and types of patient safety events within a US national pediatric population receiving HHC.

DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective cohort study (September 1, 2022, to August 31, 2023) that used staff incident reports from a pediatric HHC agency with sites in 11 US states. Participants were patients aged younger than 21 years receiving HHC within the study year, excluding psychiatric HHC.

EXPOSURE: Days of HHC receipt.

MAIN OUTCOMES AND MEASURES: Rate and type of staff-reported patient safety events per 1000 HHC-days, reviewed by 3 trained clinician reviewers, and classified using the National Coordinating Council for Medication Error Reporting and Prevention Index.

RESULTS: This study identified 2901 children (males, 1710 [59.0%]) who received a median of 98.0 (IQR, 14.0-312.0) days of HHC. The mean (SD) age was 8.7 (5.3) years. A total of 678 incident reports were filed for 348 children (11.9%). Of these, 307 (45.3%) were patient safety events, including 168 harmful errors (54.7%), 110 nonharmful errors (35.8%), and 22 hazards (7.2%). This equated to a mean (SD) of 0.68 (4.40) patient safety events per 1000 HHC-days. Errors most frequently involved medications (108 [38.8%]) and implanted devices (91 [32.7%]). Harmful errors were most frequently related to non-pressure-related skin injuries (45 [26.8%]) and falls (30 [17.9%]). Approximately half of all errors required additional monitoring (133 [47.8%]) and 45 (16.2%) required emergency care. Patient safety events were more likely in children with invasive home ventilation compared with other types of implanted medical technology.

CONCLUSIONS AND RELEVANCE: In this cohort study of children receiving HHC, more than 1 in 10 had a reported incident, of which approximately half were patient safety related. This work provides new data about pediatric HHC safety. Further work should explore factors contributing to and preventing health care-related harms to children at home and include parent perspectives.

PMID:42081246 | DOI:10.1001/jamanetworkopen.2026.10321

JAMA Netw Open. 2026 May 1;9(5):e2610380. doi: 10.1001/jamanetworkopen.2026.10380.

ABSTRACT

IMPORTANCE: Early identification of developmental delay and autism in young children improves outcomes, but screening rates in young children are low, particularly for some patient groups.

OBJECTIVE: To examine patient- and system-level characteristics associated with screening return rates and timelines and evaluate the association of an electronic health record (EHR)-based dashboard with these outcomes.

DESIGN, SETTING, PARTICIPANTS: This retrospective cohort study using EHR data from a large integrated health care system analyzed screening questionnaire return rates and time to return among children aged 6 to 66 months referred to a secondary screening program. A cross-sectional analysis (September 1, 2022, to September 1, 2023) used adjusted modified Poisson regression and restricted mean survival time (RMST). Changes in return rates, as well as time to return and time to case completion, were assessed before (November 2, 2022, to March 31, 2023) and after (November 2, 2023, to March 31, 2024) implementation of an EHR-embedded monitoring dashboard. Data were analyzed from December 5, 2023, to February 20, 2026.

EXPOSURES: Patient and organizational characteristics based on EHR data and indicators for dashboard implementation.

MAIN OUTCOMES AND MEASURES: Return rates of screening questionnaires, time to return questionnaires in days, and time to case completion in days (review questionnaire, recommendations to families, and place relevant referrals).

RESULTS: A total of 17 303 screening referral orders (11 351 [65.6%] among males; mean [SD] age, 27.73 [12.79] months; 15 853 [91.6%] aged 16-66 months) for 16 038 unique patients were included in this study. Questionnaires were returned for 7500 referrals (43.3%). Lower return rates were associated with older age (adjusted relative risk [ARR], 0.71 [95% CI, 0.68-0.75]), non-English language preference (ARR range, 0.65 [95% CI, 0.47-0.89] to 0.73 [95% CI, 0.65-0.83]), Black race (ARR, 0.79 [95% CI, 0.72-0.86]) or Hispanic ethnicity (ARR, 0.85 [95% CI, 0.81-0.89]), highest neighborhood deprivation quintile (ARR, 0.92 [95% CI, 0.86-0.98]), and Medicaid insurance (ARR, 0.85 [95% CI, 0.81-0.89]). Online portal account access was linked to higher return rates (ARR, 1.99 [95% CI, 1.75-2.26]) and faster return times (adjusted RMST difference, -6.42 days [95% CI, -7.26 to -5.59 days]). Older age was associated with longer return times (adjusted RMST difference, 6.82 days [95% CI, 5.90-7.75 days]). After dashboard implementation, return rates increased from 41.2% (2823 of 6854) to 54.7% (3883 of 7097) (ARR, 1.34 [95% CI, 1.29-1.38]), while decreases were observed for time to return (adjusted RMST difference, -6.62 days [95% CI, -7.18 to -6.07 days]) and completion (adjusted RMST difference, -37.07 days [95% CI, -38.47 to -35.67] days).

CONCLUSIONS AND RELEVANCE: The findings of this cohort study suggest that completion of recommended developmental screening can be challenging for certain patient populations. EHR-based tools may be useful to improve return rates and reduce return and case completion times.

PMID:42081245 | DOI:10.1001/jamanetworkopen.2026.10380

JAMA Netw Open. 2026 May 1;9(5):e2610552. doi: 10.1001/jamanetworkopen.2026.10552.

ABSTRACT

IMPORTANCE: Hospital-based shootings represent an extreme form of workplace violence, with notable consequences for staff, patients, and visitors. Despite growing concern, these events remain poorly understood.

OBJECTIVE: To categorize hospital-based shootings from 2012 to 2024 and incorporate prior published events between 2000 and 2011 to examine trends in shootings over a 25-year span.

EVIDENCE REVIEW: Events in this systematic review of acute care hospital-based shootings in the US from January 1, 2012, through December 31, 2024, with subgroup analysis of previously published data trending shootings over 25 years (January 1, 2000, through December 31, 2024), were identified using EBSCO Regional Business News, ProQuest US Newsstream Collection, Gun Violence Archive, and Google News Search. Selected shooting events involved at least 1 injured person (a nonperpetrator or perpetrator) that occurred within or on the immediate property of the hospital.

FINDINGS: A total of 327 news articles of unique hospital-based shooting events (5.2 per year per 1000 hospitals) were included from a review of 6658 articles, spanning 47 US states (94.0%). There was an overall incidence of 25.2 hospital-based shootings per year. Between 2012 and 2024, shootings increased by a mean (SD) of 1.7 (0.5) events per year, from 14 to 34 events (8.4% increase per year). Large hospitals accounted for the highest rate of shootings (258.1 events per 1000 hospitals). Events primarily occurred in urban settings (314 [96.0%]), and 161 (49.2%) occurred in the US South. Nearly one-third (105 [32.1%]) were potentially preventable by weapons screening. From 2000 to 2024, shootings increased by a mean (SD) of 1.1 (0.2) events per year, from 6 to 34 events (6.4% increase per year). A positive correlation was found in annual firearm fatalities in hospital settings and US firearms fatalities overall between 2012 and 2023 (r = 0.42).

CONCLUSIONS AND RELEVANCE: This systematic review found that hospital-based shootings in the US have increased steadily over the past 25 years, representing an intersection between broader national trends in workplace and firearm violence. Large hospitals, those in the US South, and hospitals in urban communities are particularly at-risk settings. These findings underscore the need for hospital-specific prevention strategies, including consideration of weapons screening technology, alongside broader societal efforts to address rising firearm violence.

PMID:42081243 | DOI:10.1001/jamanetworkopen.2026.10552

JAMA Netw Open. 2026 May 1;9(5):e2610559. doi: 10.1001/jamanetworkopen.2026.10559.

ABSTRACT

IMPORTANCE: As of September 2024, federal legislation mandates that patients be informed of their breast density, a modest breast cancer risk factor and known cancer-masking agent. This binary metric, dense vs nondense, applies to 40% to 50% of women and is subjectively assessed with interreader variability, limiting its utility for guiding supplemental imaging.

OBJECTIVE: To compare the performance of a deep learning (DL) breast cancer risk model vs radiologist-assessed breast density in estimating future breast cancer and false-negative (FN) screening results.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included consecutive bilateral screening mammograms from women 30 years or older performed from January 1, 2009, to December 31, 2018, across 5 sites of a large academic health system, with follow-up through December 31, 2023, to allow ascertainment of 5-year breast cancer outcomes.

EXPOSURES: A DL risk model applied to standard screening mammograms and radiologist-assessed breast density categorized using the American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) Atlas.

MAIN OUTCOMES AND MEASURES: Primary outcomes were breast cancer diagnoses within 5 years of mammography and FN screening results, defined as BI-RADS 1 or 2 examinations followed by a cancer diagnosis within 1 year. DL risk scores were stratified as low (<1.7%), intermediate (1.7%-3.0%), or high (>3.0%). Cancer and FN rates were compared across DL risk groups and breast density categories. Discriminatory performance was assessed using the area under the receiver operating characteristic curve (AUROC) and compared using the DeLong test.

RESULTS: Among 123 091 mammograms in 67 019 women (median [IQR] age, 58.0 [50.0-67.0] years), 50 974 (41.4%) were classified as dense. The DL model demonstrated significantly higher discriminatory accuracy than breast density in predicting future cancer (AUROC, 0.71 [95% CI, 0.70-0.72] vs 0.53 [95% CI, 0.52-0.54]; P < .001). FN rates increased across DL risk groups (2.1 per 1000 examinations in high-risk vs 1.0 and 0.6 in intermediate and low-risk groups, respectively). Women with dense breasts had higher FN rates than those with nondense breasts (1.7 vs 0.6 per 1000 examinations; P < .001). Adding breast density to the DL model did not improve performance.

CONCLUSIONS AND RELEVANCE: In this cohort study of screening mammography, a DL risk model outperformed breast density in estimating risk of future breast cancer and stratified FN screening results across risk groups. These findings support transitioning from density-based policy triggers toward more precise image-derived risk models to guide access to supplemental imaging.

PMID:42081242 | DOI:10.1001/jamanetworkopen.2026.10559

JAMA. 2026 May 4. doi: 10.1001/jama.2026.5027. Online ahead of print.

ABSTRACT

IMPORTANCE: The presence of management consultants in the US health care industry has increased dramatically in recent decades and is now higher than in most other sectors of the US economy. Hospitals hire management consultants to provide external expertise and advise on strategic planning, organizational change, cost cutting, and revenue-enhancement activities. Despite the prominence and influence of these firms, there is no empirical evidence in the US documenting either how much is spent on these services or whether that spending leads to measurable improvements.

OBJECTIVE: To quantify nonprofit hospitals’ spending on management consultants and to evaluate changes in finances, operations, and quality of care following the initiation of a contract with a management consulting firm.

DESIGN, SETTING, AND POPULATION: Observational study using a stacked difference-in-differences design to compare 306 US nonprofit hospitals that used a management consultant firm for the first time in 2010-2022 with 513 matched hospitals that did not use management consultants during 2009-2023.

EXPOSURE: First use of a management consulting firm.

MAIN OUTCOMES AND MEASURES: Financial performance (eg, revenues, expenses, margins, cash reserves, and fixed assets), operational measures (eg, inpatient utilization, staffing, executive and worker compensation, charity care, and community benefits), and quality-of-care measures (eg, claims-based 30-day mortality and readmission for acute myocardial infarction, pneumonia, and stroke).

RESULTS: More than 20% of nonprofit hospitals hired management consultants during the study period. Nonprofit hospitals that hired management consultants paid an average of $15.7 million for their services, and nonprofit hospitals collectively spent more than $7.8 billion on these services from 2009 to 2023. Despite this substantial investment, analyses of hospitals’ financial performance, operational decisions, and claims-based patient outcomes revealed little evidence of substantial, statistically significant, or systematic improvements attributable to consulting engagements. Relative changes were estimated for financial measures, such as net patient revenue (-2.22%; 95% CI, -5.11% to 0.76%; P = .14), operating expenses (-1.07%; 95% CI, -3.56% to 1.49%; P = .41), fixed assets (2.05%; 95% CI, -6.54% to 11.42%; P = .65), bad debt (-6.31%; 95% CI, -19.82% to 9.48%; P = .41), days’ cash on hand (-8.56%; 95% CI, -28.00% to 16.13%; P = .46), total margin (-0.19 [95% CI, -1.20 to 0.82] percentage points; P = .71), and operating margin (0.15 [95% CI, -0.94 to 1.23] percentage points; P = .79). Relative changes were estimated for operational measures, such as inpatient length of stay (1.71%; 95% CI, -0.34% to 3.81%; P = .10) and total inpatient days (0.29%; 95% CI, -2.57% to 3.23%; P = .85). Relative changes for quality-of-care outcomes were also generally not significant. The sole exception was 30-day readmission for patients with stroke (1.37 [95% CI, 0.14 to 2.61] percentage points; P = .03), which was not robust to alternative specifications.

CONCLUSIONS AND RELEVANCE: Nonprofit hospitals expend substantial resources on management consultants, but there was no evidence of meaningful changes in hospital finances, operations, or quality of care. These findings raise questions about the net value that nonprofit hospitals receive from management consulting services and suggest the need to carefully examine the widespread use of management consultants by hospitals and other organizations across the health care industry.

PMID:42081210 | DOI:10.1001/jama.2026.5027

Pharmaceut Med. 2026 May 4. doi: 10.1007/s40290-026-00607-z. Online ahead of print.

ABSTRACT

BACKGROUND: Children remain underrepresented in clinical research, despite regulatory frameworks like the EU Paediatric Regulation and Paediatric Investigation Plans (PIPs). The 2024 Declaration of Helsinki revision now recognises excluding vulnerable populations from research as a potential ethical concern. The Clinical Trial Regulation (EU) No 536/2014 aims to harmonise clinical trial application assessment procedures through a coordinated process involving a Reporting Member State (RMS) and Member States Concerned (MSCs).

AIMS: To determine if harmonisation is occurring, we conducted the first systematic analysis of Phase I/II paediatric trial application assessments across Member States (MS) in the European Union (EU) focusing on assessment variability, evidence requirements, PIP integration, and adolescent inclusion practices in adult trials.

METHODS: In the context of a fellowship at the European Medicines Agency, non-public data of 160 paediatric Clinical Trial Applications (CTAs) submitted through the Clinical Trial Information System (January 2022-July 2024) were screened, with inclusion of 55 Phase I/II trials in the main analysis (selected for their focus on innovative treatments and complex risk-benefit assessments). For each CTA, requests for information (consisting of considerations stated by the RMS and MSCs), assessment reports, sponsor responses, and PIP documentation were reviewed. The number of considerations in the requests for information per MS was analysed with median values calculated. Also, considerations were systemically categorised and assessment patterns between RMS and MSC roles were compared. It was examined how PIPs were integrated into assessments and approaches to adolescent inclusion in adult trials was analysed through systematic review of MS considerations.

RESULTS: Of the 160 paediatric CTAs screened, 145 received authorisation, 10 were not authorised, and 5 were withdrawn. Among the 145 authorised CTAs, 61 were Phase I/II trials, 55 of which were included in the main analysis. Analysis of these applications revealed significant heterogeneity in both the number and type of considerations raised across MS, with the median number of considerations per CTA ranging from 5.5 to 26 across MSs (p = 0.025), with particularly marked variation when MSs acted as MSCs compared to RMSs-where additional considerations ranged from zero to 25 per CTA on top of those raised by the RMS. In 36% (20/55), MSs raised concerns about insufficient (pre-)clinical evidence pointing to divergent interpretations of evidence requirements. The degree to which PIPs were integrated into CTA assessments varied considerably-ranging from strict adherence to PIP elements to minimal consideration. In 92% (11/12), MSs showed reluctance to include adolescents in adult Phase I/II trials.

CONCLUSIONS: Despite the CTR’s harmonisation goals, substantial variations persist in assessment practices across MSs, particularly regarding evidence requirements, PIP integration, and adolescent inclusion in adult trials. These variations directly impact equitable access to clinical trials for children across the EU. Urgent regulatory guidance is needed to align interpretation of evidence standards, clarify the role of PIPs in CTA evaluation, and support evidence-based approaches to adolescent inclusion in adult trials.

PMID:42081189 | DOI:10.1007/s40290-026-00607-z

Am J Reprod Immunol. 2026 May;95(5):e70250. doi: 10.1111/aji.70250.

ABSTRACT

PROBLEM: Female genital mutilation/cutting (FGM/C) is harmful to physical, mental, and reproductive health, though the effect of this practice on a woman’s HIV susceptibility is poorly understood. Despite the known associations of FGM/C with short-term vaginal epithelial damage, neither genital inflammation nor the genital microbiome have been explored in women who have undergone FGM/C. In this study we compare the genital immune milieu and microbiome among female sex workers (FSWs) by FGM/C status, hypothesizing that these biological factors are dysregulated in women who have undergone FGM/C, heightening their risk of HIV acquisition.

METHOD OF STUDY: 1003 FSWs in Nairobi, Kenya, were enrolled in the Maisha Fiti study and visited a study clinic up to three times from June 2019 to March 2021. Participants self-reported any previous exposure to FGM/C as well as other relevant sociodemographic factors. Levels of proinflammatory cytokines and soluble E-cadherin (sE-cad), a biomarker of epithelial barrier disruption, were measured by multiplex immunoassay using self-collected cervicovaginal secretion samples provided by HIV-uninfected participants. Genital inflammation was defined using a composite score of inflammatory cytokines previously associated with HIV acquisition. The presence of inflammation was compared longitudinally between groups using mixed models to control for potential confounders including age, bacterial vaginosis (BV) status as defined by Nugent score, and others. Vaginal bacterial abundance, Shannon diversity, and total levels of key vaginal bacteria were measured by qPCR and compared by FGM/C status in an exploratory analysis.

RESULTS: 44 of 1003 (4%) participants had undergone Type I or II FGM/C. These participants were older (p < 0.001) and more likely to test positive for herpes simplex virus-2 (HSV-2; p = 0.04), and less likely to have completed primary education (p = 0.03). Among HIV-uninfected participants, there was no evidence that genital inflammation was associated with FGM/C status after controlling for potential confounders (aOR = 0.70; 95% CI: 0.31-1.59; p = 0.40). There was no evidence of a difference in BV prevalence (p > 0.99), total bacterial abundance (p = 0.96), or Shannon diversity (p = 0.15) by FGM/C status.

CONCLUSIONS: Type I or II FGM/C was not associated with genital inflammation or microbial dysregulation in the long-term among HIV-negative FSWs in this cohort. This may be due to the duration elapsed since FGM/C occurred or the lowered mucosal immune activation previously observed in FSWs.

PMID:42081188 | DOI:10.1111/aji.70250