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Nevin Manimala Statistics

Surviving Extremely Low Birth Weight Infants Have a Higher Risk of ROP in Sub-Saharan Africa

Acta Paediatr. 2025 Jul 7. doi: 10.1111/apa.70216. Online ahead of print.

ABSTRACT

AIM: Retinopathy of prematurity (ROP) risk factors have been investigated in population-based studies from most global regions. No such studies are available from Sub-Saharan Africa (SSA), where improved neonatal care is increasing the survival of preterm infants at risk of ROP.

METHODS: A population-based study was conducted in infants born in Cape Town, South Africa, from 1 May 2022 to 31 January 2023. The screening criteria were birth weight < 1250 g or gestational age < 32 weeks. The data were extracted from the Retinopathy of Prematurity South African register.

RESULTS: The study included 378 screened infants, 115 (30.4%) of whom developed ROP. In the multiple regression analyses, lower birth weight was an independent ROP risk factor, OR 1.3 95% CI 1.2-1.5, p < 0.001. Surgical necrotising enterocolitis (NEC) was the only other independent ROP risk factor, OR 5.8 95% CI 1.6-21.0, p = 0.007. Infants with birth weight < 1000 g were 39.4% (130/378) of those screened and more likely to develop ROP compared to larger infants, OR 2.4 95% CI 1.5-3.9, p < 0.001.

CONCLUSION: Birth weight remained a significant ROP risk factor, especially for those born weighing less than 1000 g. These infants represented a larger proportion of screened infants compared to previous Sub-Saharan African studies.

PMID:40622745 | DOI:10.1111/apa.70216

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Potential Time and Recall Benefits for Adaptive AI-Based Breast Cancer MRI Screening

J Magn Reson Imaging. 2025 Jul 7. doi: 10.1002/jmri.70034. Online ahead of print.

ABSTRACT

BACKGROUND: Abbreviated breast MRI protocols are advocated for breast screening as they limit acquisition duration and increase resource availability. However, radiologists’ specificity may be slightly lowered when only such short protocols are evaluated. An adaptive approach, where a full protocol is performed only when abnormalities are detected by artificial intelligence (AI)-based models in the abbreviated protocol, might improve and speed up MRI screening. This study explores the potential benefits of such an approach.

PURPOSE: To assess the potential impact of adaptive breast MRI scanning based on AI detection of malignancies.

STUDY TYPE: Mathematical model.

FIELD STRENGTH/SEQUENCE: Breast cancer screening protocols.

ASSESSMENT: Theoretical upper and lower limits on expected protocol duration and recall rate were determined for the adaptive approach, and the influence of the AI model and radiologists’ performance metrics on these limits was assessed, under the assumption that any finding on the abbreviated protocol would, in an ideal follow-up scenario, prompt a second MRI with the full protocol.

STATISTICAL TESTS: Estimated most likely scenario.

RESULTS: Theoretical limits for the proposed adaptive AI-based MRI breast cancer screening showed that the recall rates of the abbreviated and full screening protocols always constrained the recall rate. These abbreviated and full protocols did not fully constrain the expected protocol duration, and an adaptive protocol’s expected duration could thus be shorter than the abbreviated protocol duration. Specificity, either from AI models or radiologists, has the largest effect on the theoretical limits. In the most likely scenario, the adaptive protocol achieved an expected protocol duration reduction of ~47%-60% compared with the full protocol.

DATA CONCLUSION: The proposed adaptive approach may offer a reduction in expected protocol duration compared with the use of the full protocol alone, and a lower recall rate relative to an abbreviated-only approach could be achieved. Optimal performance was observed when AI models emulated radiologists’ decision-making behavior, rather than focusing solely on near-perfect malignancy detection.

EVIDENCE LEVEL: Not applicable.

TECHNICAL EFFICACY: Stage 6.

PMID:40622738 | DOI:10.1002/jmri.70034

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Trends in US Children’s Mortality, Chronic Conditions, Obesity, Functional Status, and Symptoms

JAMA. 2025 Jul 7. doi: 10.1001/jama.2025.9855. Online ahead of print.

ABSTRACT

IMPORTANCE: Recent scientific and policy statements suggest that child health may be worsening in the US.

OBJECTIVE: To determine how US children’s health has been changing from 2007 to 2023 using multiple data collection methods and a comprehensive set of health indicators.

DESIGN, SETTING, AND PARTICIPANTS: Repeated, cross-sectional analyses using mortality statistics from the US and 18 comparator high-income nations from the Organisation for Economic Co-operation and Development (OECD18), 5 nationally representative surveys, and electronic health records from 10 pediatric health systems (PEDSnet). The populations included individuals younger than 20 years old. Unweighted denominator sample size ranges were 1623 to 95 677 across the surveys, 1 026 926 to 2 114 638 for PEDSnet, 81.9 million to 83.2 million in the US, and 118.4 million to 121.1 million in the OECD18 for mortality statistics.

EXPOSURE: Calendar time.

MAIN OUTCOMES AND MEASURES: Rate ratios (RRs) and annual incidence for mortality and prevalence for chronic physical, developmental, and mental health conditions, functional status, and symptoms.

RESULTS: From 2007 to 2022, infants (<1 year old) were 1.78 (95% CI, 1.78-1.79) and 1- to 19-year-old individuals were 1.80 (95% CI, 1.80-1.80) times more likely to die in the US than in the OECD18. The 2 causes of death with the largest net difference between the US and OECD18 were prematurity (RR, 2.22 [95% CI, 2.20-2.24]) and sudden unexpected infant death (RR, 2.39 [95% CI, 2.35-2.43]) for infants 12 months or younger, and firearm-related incidents (RR, 15.34 [95% CI, 14.89-15.80]) and motor vehicle crashes (RR, 2.45 [95% CI, 2.42-2.48]) for 1- to 19-year-old individuals. From 2011 to 2023, the prevalence of 3- to 17-year-old individuals with a chronic condition rose from 39.9% to 45.7% (RR, 1.15 [95% CI, 1.14-1.15]) within PEDSnet, and from 25.8% to 31.0% (RR, 1.20 [95% CI, 1.20-1.20]) within the general population. Rates of obesity, early onset of menstruation, trouble sleeping, limitations in activity, physical symptoms, depressive symptoms, and loneliness all increased during the study period.

CONCLUSIONS AND RELEVANCE: The health of US children has worsened across a wide range of health indicator domains over the past 17 years. The broad scope of this deterioration highlights the need to identify and address the root causes of this fundamental decline in the nation’s health.

PMID:40622733 | DOI:10.1001/jama.2025.9855

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Mifepristone-related foetal cardiac adverse events: findings from the postmarketing safety reports

J Obstet Gynaecol. 2025 Dec;45(1):2528093. doi: 10.1080/01443615.2025.2528093. Epub 2025 Jul 7.

ABSTRACT

BACKGROUND: This study aimed to analyse the clinical characteristics of mifepristone-associated congenital and foetal cardiac adverse events using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

METHODS: A retrospective pharmacovigilance analysis was conducted using FAERS data from Q1 2016 to Q4 2022. Disproportionality analysis was performed using the Bayesian Information Component (IC) to detect potential associations between mifepristone and congenital or foetal cardiac adverse events.

RESULTS: A total of 1,130 reports involving mifepristone were identified, of which 18 (1.59%) were related to congenital or foetal cardiac events. Most reports originated from the United States. The most frequently reported events were foetal arrhythmia and foetal heart rate disorder. Notably, foetal arrhythmia showed the strongest signal (IC = 3.13, CI025 = 1.37). No disproportional signals were detected for structural cardiac malformations. A partial assessment of the Bradford Hill criteria suggested a possible association with functional cardiac anomalies.

CONCLUSION: This study did not identify an association between mifepristone exposure and structural congenital heart defects. However, a positive signal for transient foetal heart rhythm abnormalities was observed. Clinicians should remain vigilant for foetal heart rate irregularities following maternal mifepristone use and consider enhanced cardiac monitoring during labour and delivery to enable early detection and management.

PMID:40622732 | DOI:10.1080/01443615.2025.2528093

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Youths Experiencing Parental Death Due to Cancer

JAMA Netw Open. 2025 Jul 1;8(7):e2519106. doi: 10.1001/jamanetworkopen.2025.19106.

NO ABSTRACT

PMID:40622718 | DOI:10.1001/jamanetworkopen.2025.19106

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Multilevel Intervention and Human Papillomavirus Vaccination Disparities: A Secondary Analysis of a Cluster Randomized Trial

JAMA Netw Open. 2025 Jul 1;8(7):e2518895. doi: 10.1001/jamanetworkopen.2025.18895.

ABSTRACT

IMPORTANCE: Uptake of human papillomavirus (HPV) vaccination varies by characteristics, exposing some children to higher HPV cancer risks than others.

OBJECTIVE: To examine whether the effectiveness of a multilevel intervention on HPV vaccination differed by race and ethnicity, rurality, and Area Deprivation Index (ADI) in children ages 11 to 12 years.

DESIGN, SETTING, AND PARTICIPANTS: A stepped-wedge cluster randomized trial was conducted from April 2018 to August 2022 among children at 6 Mayo Clinic primary care practices in Minnesota to improve HPV vaccination. This secondary analysis was performed from March to June 2024.

INTERVENTION: A multilevel intervention that included parent reminder/recall letters, which alerted parents of children due or past due for vaccination, and health care professional audit/feedback reports, which alerted health care professionals of their own vaccination rates.

MAIN OUTCOME AND MEASURE: Vaccine initiation (first dose of the 2-dose HPV vaccine) and vaccine completion (second dose) were the primary study outcomes. In this secondary analysis, the effect of the intervention on HPV vaccine initiation and completion by race and ethnicity, rurality, and ADI quartiles (Qs) was assessed.

RESULTS: A total of 6232 children aged 11 to 12 years (3285 [52.7%] male; 3481 [55.9%] aged 11 years and 2751 [44.1%] aged 12 years) were included in the analysis. Of the study participants, 304 (4.9%) were Asian, 561 (9.0%) Black, 146 (2.3%) Hispanic, 4501 (72.2%) White, and 720 (11.6%) other, including American Indian or Alaskan Native, Native Hawaiian or Pacific Islander, Other Pacific Islander, Samoan, unable to provide, unknown, chose not to disclose, or other unspecified. A total of 5434 participants (87.2%) were urban residents, and 2794 (44.8%) resided in ADI Q2 areas. With usual care, HPV vaccine initiation and completion rates were significantly lower with each increasing ADI quartile (initiation: Cochran-Armitage test for trend [SE], -0.02 [0.01]; P < .001; completion: Cochran-Armitage test for trend [SE], -0.05 [0.01]; P < .001) but did not differ by children’s race and ethnicity or rurality. With the intervention, vaccine initiation increased significantly for most children (range of rates, 9.2% [95% CI, 5.2%-13.3%] to 24.0% [95% CI, 7.5%-40.6%]) except those with Black race, in rural settings, and in ADI Q4 (highest area deprivation); vaccine completion increased significantly for most children (range of rates, 19.4% [95% CI, 5.5%-33.3%] to 31.2% [95% CI, 12.1%-50.3%]) except for those in ADI Q4.

CONCLUSIONS AND RELEVANCE: In this secondary analysis of a cluster randomized trial, a multilevel intervention was associated with increased HPV vaccination for most children but had limited effect for those residing in areas of highest deprivation. Future research should explore other intervention strategies that would effectively promote HPV vaccination among families in socioeconomically disadvantaged areas to reduce HPV vaccination disparities.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03501992.

PMID:40622715 | DOI:10.1001/jamanetworkopen.2025.18895

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Exogenous Hormones, Tumor Intrinsic Subtypes, and Breast Cancer

JAMA Netw Open. 2025 Jul 1;8(7):e2519236. doi: 10.1001/jamanetworkopen.2025.19236.

ABSTRACT

IMPORTANCE: Etiologic heterogeneity in breast carcinogenesis needs to be well characterized for targeted prevention. Associations between menopausal hormonal therapy (MHT) and oral contraceptive (OC) use and breast cancer intrinsic-like subtypes are not well understood.

OBJECTIVE: To examine whether exogenous hormone use is differentially associated with breast cancer subtypes and to evaluate heterogeneity by intrinsic-like subtypes.

DESIGN, SETTING, AND PARTICIPANTS: This study pooled data from 31 nested and population-based case-control studies involved in the Breast Cancer Association Consortium. The study population included individuals with breast cancer and control participants from 13 case-control studies nested in prospective cohorts (recruited between 1982 and 2011) and 18 population-based case-control studies (recruited between 1990 and 2013). Data analysis was performed in June 2024.

EXPOSURE: MHT use (estrogen-progestin therapy [EPT] or estrogen-only therapy [ET]) in postmenopausal women and OC use in premenopausal women (never, past use, or current use).

MAIN OUTCOMES AND MEASURES: Breast cancer intrinsic-like subtypes (luminal A-like, luminal B-like, luminal B-ERBB2 [formerly HER2 or HER2/neu]-like, ERBB2 enriched-like, or triple-negative) were determined by immunohistochemistry of tumor sections. Polytomous logistic regression was performed to estimate the association between exogenous hormones and risk of breast cancer by intrinsic-like subtypes. Analyses by subtypes were stratified by body mass index (BMI [calculated as weight in kilograms divided by height in meters squared]; healthy weight, 18.5-<25; overweight, 25-<30; or obesity, ≥30).

RESULTS: This study included 42 269 individuals with breast cancer (11 901 [28.2%] premenopausal and 30 368 [71.8%] postmenopausal; 23 353 [55.2%] had a known intrinsic-like subtype) and 71 072 control participants. The mean (SD) age of all participants was 57.9 (10.9) years. In postmenopausal women, associations between current MHT use (EPT or ET) and breast cancer differed by subtype. Current EPT users with healthy weight were more likely to be diagnosed with luminal A-like (odds ratio [OR], 2.51 [95% CI, 2.26-2.80]) or luminal B-ERBB2-like (OR, 1.95 [95% CI, 1.61-2.37]) subtypes. These associations were attenuated but remained for individuals with overweight (OR, 1.40 [95% CI, 1.02-1.92]) or obesity (OR, 1.68 [95% CI, 1.01-2.78]). EPT use increased the odds of being diagnosed with luminal B-like tumors solely in women with healthy weight (OR, 1.47 [95% CI, 1.17-1.86]). Current ET use was positively associated with luminal A-like disease in women with healthy weight only (OR, 1.16 [95% CI, 1.01-1.32]), showing inverse associations with higher BMI (obesity: OR, 0.65 [95% CI, 0.50-0.85]). In premenopausal women, recent OC use was associated with luminal B-ERBB2-like (OR, 1.50 [95% CI, 1.09-2.08]), ERBB2 enriched-like (OR, 2.33 [95% CI, 1.55-3.51]), and triple-negative (OR, 1.75 [95% CI, 1.33-2.29]; P < .04 for heterogeneity) tumors.

CONCLUSIONS AND RELEVANCE: In this study, clear differences were observed in associations between current EPT use and luminal-like breast cancer subtypes and other subtypes. EPT users with healthy weight were more likely to be diagnosed with luminal-like breast cancer compared with nonusers. Subtype heterogeneity was less apparent in associations of OC and ET use. Future studies on contemporary formulations, patterns of use, and routes of administration of exogenous hormone usage are warranted.

PMID:40622713 | DOI:10.1001/jamanetworkopen.2025.19236

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Firearm Storage and Firearm Suicide

JAMA Netw Open. 2025 Jul 1;8(7):e2519266. doi: 10.1001/jamanetworkopen.2025.19266.

ABSTRACT

IMPORTANCE: Suicide-prevention interventions often recommend removing firearms from the homes of individuals at elevated risk of suicide or, short of removal, locking and unloading all household firearms. The recommendation to remove firearms is based on strong and consistent evidence. For adults, however, the recommendation to lock firearms is based on few studies with inconsistent findings.

OBJECTIVE: To assess the association between firearm storage practices and suicide method by sex and age.

DESIGN, SETTING, AND PARTICIPANTS: This case-control study investigated decedents aged 15 years or older who lived in a home with firearms in the last year of their life and who died by suicide. Data were from the 1993 National Mortality Followback Survey. Analyses were conducted from June 1, 2024, to March 30, 2025.

EXPOSURES: The presence of 1 or more unlocked firearm in the decedent’s residence and/or 1 or more loaded firearm.

MAIN OUTCOMES AND MEASURES: The main outcome was firearm storage practices by suicide method. Logistic models, including both exposures, compared the relative odds of exposure among decedents who died by firearm suicide vs nonfirearm suicide, adjusted for sex, age, and region of residence at the time of death.

RESULTS: Among the 725 individuals who died by suicide (mean [SD] age, 47.1 [19.7] years; 554 males [85.0%]), 606 (83.6%) decedents died by firearm suicide and 119 (16.4%) died by nonfirearm suicide. Adult suicide decedents who used firearms were neither more nor less likely than those who used other suicide methods to have lived in a home where all firearms were locked (odds ratio [OR], 1.15 [95% CI, 0.67-1.95]) or unloaded (OR, 0.78 [95% CI, 0.44-1.36]). Corresponding ORs for locked firearms were 1.29 (95% CI, 0.69-2.44) for men and 0.58 (95% CI, 0.24-1.41) for women; for unloaded firearms, ORs were 0.80 (95% CI, 0.41-1.56) for men and 0.61 (95% CI, 0.25-1.51) for women. Among adolescent and young adult (hereinafter adolescent) decedents aged 15 to 20 years, approximately half (26 of 43 [60.5%]) who died by firearm suicide, but none of the 7 who died by nonfirearm suicide, had lived in a home with unlocked firearms. Among adolescents in households in which all firearms were locked, suicide method was not associated with whether any firearm was unloaded (OR, 1.36 [95% CI, 0.10-18.9]).

CONCLUSIONS AND RELEVANCE: In this case-control study, neither locking nor unloading household firearms was associated with whether adults used a firearm in their suicide. By contrast, adolescents who died by firearm suicide were far more likely to have lived in a household with unlocked firearms than were adolescent decedents who died by nonfirearm suicide methods. Suicide-prevention approaches that aim to reduce suicide mortality, especially for adult subpopulations likely to own firearms, should focus on firearm access rather than storage practices.

PMID:40622712 | DOI:10.1001/jamanetworkopen.2025.19266

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Immune Checkpoint Inhibitors and Survival Disparities by Health Insurance Coverage Among Patients With Metastatic Cancer

JAMA Netw Open. 2025 Jul 1;8(7):e2519274. doi: 10.1001/jamanetworkopen.2025.19274.

ABSTRACT

IMPORTANCE: The introduction of immune checkpoint inhibitors (ICIs) has been associated with substantial improvement in median survival among individuals with cancer; however, people without health insurance coverage may be unable to afford ICIs due to their high costs.

OBJECTIVE: To examine the association between the introduction of ICIs and changes in survival disparities by health insurance coverage among people with a new diagnosis of advanced-stage cancer.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study was conducted among individuals who received a new diagnosis at age 18 to 64 years of stage IV melanoma (n = 12 048), non-small cell lung cancer (NSCLC; n = 152 610), or renal cell carcinoma (RCC; n = 18 782) who were identified from the National Cancer Database before and after US Food and Drug Administration approval of ICIs (January 1, 2002, to December 31, 2019, for melanoma and January 1, 2010, to December 31, 2019, for other cancers). Statistical analysis was conducted from December 2023 to April 2025.

EXPOSURE: Health insurance coverage at the time of diagnosis (private, Medicaid, or uninsured).

MAIN OUTCOMES AND MEASURES: The primary study outcome was 2-year overall survival. For each type of cancer, a 6-group propensity score weighting difference-in-differences (DID) approach was applied to examine the changes in 2-year survival before and after the ICI approval date among individuals without insurance or with Medicaid compared with those with private insurance.

RESULTS: Among the 183 440 individuals included, the mean (SD) age was 55.5 (7.0) years, and 56.5% were male. Two-year overall survival rates increased post-ICI approval among uninsured individuals (from 16.2% to 28.3%) and individuals with private insurance (from 28.7% to 46.0%) for those with a diagnosis of melanoma, resulting in a widening disparity of 6.1 percentage points (pp) (95% CI, 1.7-10.6 pp) after adjusting for sociodemographic characteristics. Similarly, among people with a diagnosis of NSCLC, the survival disparity between people without insurance and people with private insurance widened to 1.3 pp (95% CI, 0.2-2.3 pp). Survival differences between people with Medicaid and those with private insurance did not change significantly with the introduction of ICIs (DID for melanoma, -1.9 pp [95% CI, -5.6 to 1.8 pp]; DID for NSCLC, 0.4 pp [95% CI, -0.4 to 1.2 pp]; and DID for RCC, -3.8 pp [95% CI, -9.4 to 1.9 pp]).

CONCLUSIONS AND RELEVANCE: This serial cross-sectional study found that the introduction of ICIs was associated with widening survival disparity between people without health insurance and those with private insurance. Policies expanding access to health insurance coverage options and making new treatments more affordable are needed.

PMID:40622711 | DOI:10.1001/jamanetworkopen.2025.19274

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All-pedicle screw posterior spinal fusion after magnetically controlled growing rods in walking early-onset scoliosis patients: radiographic and surgical outcomes

Spine Deform. 2025 Jul 7. doi: 10.1007/s43390-025-01139-3. Online ahead of print.

ABSTRACT

PURPOSE: Early-onset scoliosis (EOS) significantly affects lung development and life expectancy. Magnetically Controlled Growing Rods (MCGR) effectively promote thoracic growth while managing curvature progression. This study aims to assess the impact of definitive spinal fusion on residual deformity and complications in EOS patients treated with MCGRs.

METHODS: The study included 27 EOS patients who underwent final fusion surgery between January 2017 and September 2022. The primary outcome was the evaluation of coronal and sagittal radiographic parameters postoperatively and at a minimum of 2 years of follow-up (FUP). Secondary outcomes included major complications (≥ IIIB, according to Clavien-Dindo Classification), surgery duration, blood loss and length of hospital stay (LOS).

RESULTS: Major curve (45.5° and 33.5°, p = 0.003, Brunner-Munzel Test Statistic = – 3.869254) and Thoracic Kyphosis (TK) (19.8° and 13.5°, p = 0.002, Brunner-Munzel Test Statistic = – 2.258845) were statistically impacted by arthrodesis, and maintained at the final follow-up. The surgeries had an average duration of 254.2 ± 39.5 min (range: 195-336 min) and an average blood loss of 574.1 ± 255.1 mL (range: 200-1300 mL). The mean LOS was 8.5 ± 1.8 days (range: 6-13 days). Following the final fusion, 5 patients (18.5%) developed a complication, of which one was classified as major.

CONCLUSIONS: This study demonstrated substantial improvements in coronal and sagittal alignment following graduation surgery, with results maintained at the two-year FUP. Further research with larger sample sizes is needed to provide a more comprehensive assessment of radiographic and surgical outcomes and to establish guidelines for implant density in MCGR graduation surgery.

PMID:40622674 | DOI:10.1007/s43390-025-01139-3