Category: Statistics

J Glob Health. 2025 Dec 5;15:04291. doi: 10.7189/jogh.15.04291.

ABSTRACT

BACKGROUND: Globally, the issue of ischaemic heart disease (IHD) has emerged as a prominent public health challenge in the ongoing process of ageing. Previous assessments relied upon data constrained by geographical scope and lacking a thorough worldwide evaluation. We aimed to present the incidence, prevalence, death, and disability-adjusted life years (DALYs) due to IHD at global, regional, and national levels from 1990 to 2021, emphasising decomposition and progressive analysis. We aim to provide relevant information to guide health policy decisions, allocate medical resources effectively, and improve patient care protocols for greater efficiency.

METHODS: We aimed to accurately depict the health impact of IHD by applying standardised Global Burden of Disease approaches and analysing four key epidemiological indicators: prevalence, incidence, mortality, and DALYs. We quantified temporal trends in the burden of IHD from 1990 to 2021 using the estimated annual percentage change (EAPC) metric. We conducted an in-depth examination of global trends, categorising them by age group, gender, and the sociodemographic index (SDI) to provide a more nuanced understanding. Decomposition analyses of IHD DALYs, which examine the effects of age distribution, population dynamics, and changes in disease patterns, enabled us to accurately quantify the specific contributions of each factor to the overall IHD burden. Using frontier analytical methods, we intended to pinpoint the minimal plausible burden of IHD, contingent on the level of development, as gauged by the SDI.

RESULTS: In 2021, the age-standardised incidence rate (ASIR) of IHD decreased compared with 1990 (EAPC = -0.44; 95% confidence interval = -0.47, -0.42). Moreover, the age-standardised mortality rates (ASMR) and DALYs (ASDR) decreased over time. The overall IHD burden was marginally higher in males than in females. The global rates for prevalence, incidence, deaths, and DALYs related to IHD demonstrated an overall rising trend along with age. Among all regions, the North Africa and Middle East region exhibited the highest ASIR (ASIR = 895.85; 95% uncertainty interval (UI) = 786.65, 1043.49) and age-standardised prevalence rate (ASPR) (ASPR = 6404.84; 95% UI = 5872.02, 7041.08) for IHD in 2021. Central Asia recorded the highest ASMR (ASMR = 265.51; 95% UI = 240.67, 290.42) and ASDR (ASDR = 4864.49; 95% UI = 4415.55, 5338.75) in 2021. Decomposition analysis revealed population growth and ageing as primary factors driving the rise in IHD DALYs. Frontier analysis illuminated ample room for enhancement across the entire development continuum.

CONCLUSIONS: The variability in IHD burden is influenced by gender, age, and geographic location. The global burden of IHD has persistently increased during the last three decades, notably among older males. The escalating ageing population and demographic expansion underscore the importance of bolstering public health measures and optimising resource allocation, particularly in etiological investigation, prompt diagnosis, preventive measures, and locally tailored management for IHD.

PMID:41343197 | DOI:10.7189/jogh.15.04291

J Glob Health. 2025 Dec 5;15:04359. doi: 10.7189/jogh.15.04359.

ABSTRACT

BACKGROUND: With declining funding for population-based household surveys, routine health facility data offer a promising alternative for tracking newborn health and service quality. However, their utility depends on data quality. We assessed the quality of ten data elements within routine health information systems in the Central African Republic (CAR), Ethiopia, Tanzania, and Uganda, seven of which align with the Every Newborn Action Plan core newborn indicators.

METHODS: We conducted a cross-sectional study in 97 emergency obstetric and newborn care facilities across 4 countries between November 2022 and July 2024. We extracted three months of routine register and summary report data on ten maternal and newborn elements (two denominators, three outcome numerators, five newborn care interventions) and one tracer maternal indicator. We evaluated data quality on four dimensions (availability, completeness, accuracy, and internal consistency) and measured internal consistency using the ratio of (total births – live births)/stillbirths, with a value of 1 suggesting ideal internal consistency.

RESULTS: Denominator completeness exceeded 90% in Uganda and Tanzania, but was lower in the CAR (87%) and Ethiopia (82%). Impact numerator completeness averaged 79% for neonatal mortality and 81% for low birth weight, with Ethiopia performing worst, with scores of 45% and 32%, respectively). Completeness for newborn interventions (early breastfeeding, kangaroo mother care, bag-mask ventilation, sepsis management) remained below 90%, with the CAR lacking neonatal sepsis data and Ethiopia lacking early breastfeeding data. Accuracy was poor: concordance between register recounts and summary reports ranged from 9% to 40%. Internal consistency checks revealed mismatches in 80% of facilities, including negative ratios in Uganda and ratios >1 in the CAR.

CONCLUSIONS: Significant gaps in completeness, accuracy, and internal consistency undermine the reliability of newborn and stillbirth data in routine health information systems, highlighting a need for their strengthening, the integration of standardised newborn indicators, and institutionalized quality verification processes to ensure timely, reliable, and actionable data for improving newborn care.

PMID:41343194 | DOI:10.7189/jogh.15.04359

JAMA Otolaryngol Head Neck Surg. 2025 Dec 4. doi: 10.1001/jamaoto.2025.4203. Online ahead of print.

ABSTRACT

IMPORTANCE: Historical evidence demonstrated that delays or interruptions in radiotherapy (RT) are associated with poorer oncologic outcomes in head and neck squamous cell carcinoma (HNSCC). Substantial concerns arose during the COVID-19 pandemic, when treatment schedules were frequently disrupted.

OBJECTIVE: To determine the association of RT interruptions with locoregional failure (LRF) and overall survival (OS).

DESIGN, SETTING, AND PARTICIPANTS: This retrospective review and secondary analysis of 3 randomized clinical trials (NRG/RTOG 0129, 0522, and 1016) included patients enrolled in the trials who were treated with RT. Patients with HNSCC were grouped as (1) p16-positive oropharynx (p16+ OPSCC) and (2) p16-negative oropharynx and all other subsites regardless of p16 status (called locally advanced HNSCC [LAHNSCC])). Cox proportional hazards models were fit to assess the association of an RT interruption (binary model) and length of RT interruption (continuous model) with LRF and OS.

EXPOSURES: Presence of RT interruption.

MAIN OUTCOMES AND MEASURES: LRF and OS.

RESULTS: There were 1549 patients (200 female patients [12.9%]; mean [SD] age, 57 [6] years; 1048 p16+ OPSCC [67.7%]; 501 LAHNSCC [32.3%]) who were included in the binary model; 439 (28.3%) had RT interruption. There were 1083 patients (69.9%) with available length of RT interruption (continuous model). A binary RT interruption was associated with hazard ratios (HRs) of 1.04 (95% CI, 0.90-1.36) for LRF and 1.22 (95% CI, 0.99-1.50) for OS. As a continuous predictor, each 7-day interruption corresponded to HRs of 1.45 (95% CI, 1.12-1.89) for LRF and 1.41 (95% CI, 1.07-1.86) for OS. Analyses did not indicate effect modification by p16 status, and results are presented from models that estimated the effect of RT interruption across both groups. Using covariate-adjusted predictions from models that included clinical and tumor characteristics, a mean 7-day interruption in RT was associated with a 3-year LRF decrement of 4.1% in p16+ OPSCC and 9.1% in LAHNSCC. Predicted 3-year LRF detriment due to RT interruption ranged from 2.0% for a patient with non-T4, non-N3, p16+ OPSCC to 11.2% for a patients with LAHNSCC with a T4N3 p16-negative cancer.

CONCLUSIONS AND RELEVANCE: The secondary analysis suggests that RT treatment interruptions may be negatively associated with LRF and OS in HNSCC, but the magnitude of the association varies depending on p16 status and clinical characteristics. While treatment interruptions should globally be discouraged, patients with LAHNSCC or higher-stage disease may be most affected.

TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT00047008; NCT00265941; NCT01302834.

PMID:41343184 | DOI:10.1001/jamaoto.2025.4203

J Glob Health. 2025 Dec 5;15:04319. doi: 10.7189/jogh.15.04319.

ABSTRACT

BACKGROUND: Evidence regarding the association between physical activity (PA) and diabetic retinopathy (DR) remains inconsistent. Furthermore, its effects on retinal vessel diameters in type 2 diabetes are not well established. We aimed to investigate the relationship between PA, DR, and retinal vessel diameters, explore underlying mechanisms, and identify protective exercise regimens.

METHODS: We included patients with type 2 diabetes from the Shanghai Cohort Study of Diabetic Eye Disease. Retinal vessel diameters were measured using computer vision and deep learning. Anthropometric data were collected using standard methods, and PA data through interviews. In 2017, participants were categorised by their DR status. Those without DR were divided into active and inactive groups and followed for three years to assess the effect of PA. For statistical analyses, we used independent t-tests, χ² tests, one-way analysis of variance, Bonferroni tests, multiple linear and logistic regression models, Kaplan-Meier, and Cox regression models.

RESULTS: In the cross-sectional analysis, we analysed a sample of 42 992 individuals, with a mean age of 64.42 (standard deviation (SD) = 6.87) years. PA was associated with reduced odds of moderate and severe non-proliferative DR, and with wider retinal arterioles and venules. In the longitudinal cohort, we analysed 3669 individuals, with a mean age of 63.1 (SD = 6.65) years. PA was a protective factor against incident DR (hazard ratio = 0.812; 95% confidence interval = 0.679-0.971) and was associated with increased peripheral retinal arteriolar calibre and arterio-venous ratio.

CONCLUSIONS: PA improved retinal vessel diameters and lowered DR incidence, highlighting the necessity for further research into the physiological mechanisms linking PA and DR. Promoting awareness and engagement in moderate/high-intensity exercise may enhance diabetes health management.

REGISTRATION: ClinicalTrials.gov NCT03665090.

PMID:41343177 | DOI:10.7189/jogh.15.04319

JAMA Oncol. 2025 Dec 4. doi: 10.1001/jamaoncol.2025.5144. Online ahead of print.

ABSTRACT

IMPORTANCE: Observational studies have associated use of aspirin and selective cyclooxygenase inhibitors with decreased recurrence and improved survival in patients with colon cancer. While randomized clinical trials have not shown benefit across all patients, these findings suggest that select subgroups may benefit from their use. Despite the well-established prognostic value of circulating tumor DNA (ctDNA), its role in guiding treatment remains unclear.

OBJECTIVE: To investigate the predictive value of postoperative ctDNA for survival outcomes with adjuvant celecoxib alongside conventional chemotherapy in patients with stage III colon cancer.

DESIGN, SETTING, AND PARTICIPANTS: This was a post hoc analysis of the phase 3 Cancer and Leukemia Group B (now Alliance)/Southwest Oncology Group 80702 randomized clinical trial (2010-2015) assessing adjuvant celecoxib vs placebo and 3 vs 6 months of adjuvant 5-fluorouracil, leucovorin, and oxaliplatin for stage III colon cancer. Patients consented to biospecimen collection and had ctDNA analysis performed. Data analysis was performed from September 2024 to June 2025.

EXPOSURES: Postoperative ctDNA positivity was determined using a clinically validated, tumor-informed 16-plex-polymerase chain reaction-next-generation sequencing assay (Signatera; Natera Inc) performed between surgery and initiation of adjuvant therapy.

MAIN OUTCOMES AND MEASURES: Disease-free survival (DFS) and overall survival (OS). Survival by ctDNA status and adjuvant celecoxib use were assessed as part of a post hoc companion study with prespecified statistical analysis plan.

RESULTS: Among 940 patients (mean [SD] age, 60.9 [10.8] years; 426 female [45.3%] and 515 male [54.7%] individuals; 222 [23.6%] with prior low-dose aspirin use; and median follow-up of 6.0 [95% CI, 6.0-6.0] years), 767 (81.6%) were ctDNA negative and 173 (18.4%) were ctDNA positive. ctDNA positivity was highly prognostic of worse DFS (reference, ctDNA negativity; adjusted hazard ratio [aHR], 6.12; 95% CI, 4.66-8.03) and OS (aHR, 5.86; 95% CI, 4.19-8.19). In patients with ctDNA positivity, celecoxib was associated with improved DFS (aHR, 0.61; 95% CI, 0.42-0.89) and OS (aHR, 0.62; 95% CI, 0.40-0.96) compared to placebo. Among patients with ctDNA negativity, celecoxib did not provide survival benefit (DFS: aHR, 0.76; 95% CI, 0.53-1.09; OS: aHR, 0.85; 95% CI, 0.54-1.36), although the interaction was not significant (P for interaction, .41 and .33 for DFS and OS, respectively). These findings persisted when stratifying patients by microsatellite instability status and PIK3CA mutational status.

CONCLUSION AND RELEVANCE: The findings of this post hoc analysis suggest that ctDNA status has the potential to inform clinical decision-making among patients with stage III colon cancer who should consider adjuvant celecoxib in addition to conventional chemotherapy.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01150045.

PMID:41343176 | DOI:10.1001/jamaoncol.2025.5144

J Glob Health. 2025 Dec 5;15:04314. doi: 10.7189/jogh.15.04314.

ABSTRACT

BACKGROUND: Low physical activity (LPA) is associated with cardiovascular and cerebrovascular pathologies. This study aimed to assess the prevalence of several noncommunicable diseases relating to LPA.

METHODS: Using the 2021 Global Burden of Disease data set, we modelled LPA-related disease burdens across 204 countries and territories, quantifying mortality counts, age-standardised mortality rates, and disability-adjusted life years (DALYs) for five noncommunicable diseases. We conducted multivariable stratification analyses to assess variations by gender, age, and sociodemographic index (SDI) quintiles. We used age-period-cohort modelling to project burden trajectories, while applying counterfactual decomposition frameworks to delineate synergistic interactions between LPA and risk factors.

RESULTS: We found that LPA accounted for 555 101 related deaths globally in 2021 across the five studied pathologies, mostly among individuals aged 60-94 years. Association between LPA-related disease burden and SDI followed a U-shaped distribution across regions and diseases. Among individuals aged 60-89 years, LPA-related deaths were significantly higher in women than in men, indicating a disproportionate burden on elderly females. Ischaemic heart disease (IHD) trends stabilised in low- and middle-SDI regions but declined significantly in high-SDI regions, underscoring global health disparities. From 2007 to 2011, LPA DALYs and mortality risk ratios for IHD, stroke, and lower extremity peripheral arterial disease declined from >1 to <1, whereas diabetes mellitus exhibited an opposite trend, highlighting LPA’s persistent and significant impact on diabetes-related morbidity. Demographic shifts and epidemiological transitions were primary drivers of LPA-related disease burden across five pathologies. In high-SDI regions, epidemiological changes predominated, whereas population growth was a key factor in low- and middle-SDI regions. Synergistic interaction of these factors with LPA is projected to substantially amplify future disease burden.

CONCLUSIONS: Physical activity should be increased among elderly women to address health risks associated with LPA. Likewise, urgent public health interventions are needed for LPA-related diabetes. As IHD burden rises in low- and middle-SDI regions, vascular disease care strategies require optimisation. Moreover, high-SDI regions should strengthen nationwide physical activity promotion, while low- and middle-SDI areas must enhance healthcare infrastructure and manage population growth to reduce LPA-related disease burdens.

PMID:41343173 | DOI:10.7189/jogh.15.04314

Clin Drug Investig. 2025 Dec 4. doi: 10.1007/s40261-025-01501-3. Online ahead of print.

ABSTRACT

BACKGROUND: With shifting perceptions about the therapeutic potential of cannabis and evolving regulatory frameworks, global prescribing of medicinal cannabis is increasing. While some emerging evidence supports its use for conditions like multiple sclerosis and epilepsy, its efficacy and safety profile for the treatment of mental health conditions remains controversial and under-explored. Previous reviews found inconclusive evidence due to heterogeneity in study design and quality. Accordingly, this review was designed as a scoping review, consistent with established methodological frameworks to map and characterise all available randomised controlled trial (RCT) evidence in this emerging and heterogeneous field. It specifically sought to synthesise the highest-quality trial evidence to date, addressing the question: How effective is medicinal cannabis in treating mental health conditions, as classified by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and how safe and tolerable is it, as assessed through adverse events and treatment withdrawals?

METHODS: A scoping review was conducted comprising RCTs investigating medicinal cannabis for mental health conditions. Eligible studies were required to meet predefined inclusion criteria based on population, intervention, comparator, outcomes, and study design (PICOS framework). PubMed, Web of Science, and PsycINFO databases were searched, supplemented by citation tracking and Google Scholar, for studies published between 1980 and 2024.

RESULTS: The search identified 8061 studies, with 28 RCTs meeting inclusion criteria across 12 DSM-5 mental health conditions. Indications most frequently studied were schizophrenia (n = 5), cannabis use disorder (n = 4), cocaine use disorder (n = 4), post-traumatic stress disorder (n = 3), anxiety disorders (n = 3), and opioid use disorder (n = 2); there were two trials in autism spectrum disorder and single trials in depression, attention-deficit/hyperactivity disorder, obsessive-compulsive disorder, tobacco use disorder, and Tourette syndrome. Sample sizes ranged from 6 to 150 participants (median = 42), and follow-up durations from 1 day to 13 weeks (median = 6 weeks). Interventions included purified cannabidiol (CBD; single doses of 300-800 mg and daily regimens up to 1000 mg/day), nabiximols or other tetrahydrocannabinol (THC)/CBD oromucosal sprays (up to 113 mg THC/105 mg CBD per day), and smoked or vaporised cannabis flower of varying THC/CBD content. Findings showed substantial heterogeneity and variable quality, with some short-term benefits reported (notably in cannabis use disorder, autism spectrum disorder, and schizophrenia), but no trial demonstrated long-term efficacy.

CONCLUSION: Despite growing interest, substantial heterogeneity limits current evidence for medicinal cannabis in mental health. This review highlights key gaps, underscoring the need for robust, well-powered RCTs with extended follow-up to clarify its role in the management of mental ill health.

PMID:41343139 | DOI:10.1007/s40261-025-01501-3

Obes Surg. 2025 Dec 4. doi: 10.1007/s11695-025-08376-5. Online ahead of print.

ABSTRACT

Obesity is caused by caloric intake exceeding over time, Obesity has multiple effects on the capacity to get and sustained an erection. Obesity and ED in males appear to be linked in many studies. Obesity is a significant risk factor for the progress of ED, which is a serious Clinical issue. This study was performed to assess the impact of weight loss induced by laparoscopic sleeve gastrectomy (LSG) on male sex hormones and erectile function among morbid obese male patients. The study was done over 32 morbidly obese married male cases who underwent LSG for weight reduction after doing assessments during their preoperative preparation. All subjects were evaluated by 4 questionnaires and serum hormone profiles pre-and postoperatively. Our study showed statistically significant improvement in the erectile function, and the Erection Hardness Score among morbid obese men undergoing LSG after 6 months of operation. Also showed statistically significant increasing levels of testosterone and decreasing levels of Estradiol (E2) after 6 months of operation. LSG is effective with significant enhancement of the Bariatric Quality of Life and Bariatric Body Image Satisfaction.

PMID:41343134 | DOI:10.1007/s11695-025-08376-5

Rheumatol Ther. 2025 Dec 4. doi: 10.1007/s40744-025-00811-4. Online ahead of print.

ABSTRACT

INTRODUCTION: This study evaluated the real-world effectiveness of tofacitinib monotherapy versus combination therapy in patients with psoriatic arthritis (PsA) enrolled in the CorEvitas PsA/Spondyloarthritis Registry.

METHODS: This study (NCT05195814) included adult patients with PsA initiating tofacitinib (from December 14, 2017 to October 1, 2023) as monotherapy, or in combination with oral small molecules (OSMs: methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, and apremilast). Patients with baseline and 6-month follow-up visits (± 3 months) were included.

OUTCOMES: mean change from baseline (∆) in/proportions achieving, disease activity measures (including body surface area [BSA] = 0%), and patient-reported outcomes. Continuous endpoints at month 6 were analyzed as ∆ with an analysis of covariance model including treatment and baseline value as covariates. ∆ in least squares (LS) means and adjusted LS means/odds ratios are presented.

RESULTS: The study included 141 patients (66/141 monotherapy; 75/141 combination therapy). Patients were predominantly female (61.0%) and white (94.3%), and average age was 56.7 years. More monotherapy initiators were OSM treatment-naïve and had higher mean Patient Global Assessment of Arthritis, compared with combination therapy initiators. By 6 ± 3 months, 28.8% and 25.3% of monotherapy and combination therapy initiators, respectively, discontinued tofacitinib. At 6 ± 3 months, 15.0% of monotherapy initiators achieved minimal disease activity, and 27.1% had BSA = 0%. Corresponding data for combination therapy initiators were 20.7%, and 22.0%, respectively. Differences between groups were not significant. LS mean differences from baseline in overall work impairment/activity impairment were – 13.0/- 21.8 and 1.4/- 2.9 for monotherapy and combination therapy initiators, respectively.

CONCLUSION: Monotherapy and combination therapy initiators demonstrated improvements across effectiveness outcomes. Tofacitinib monotherapy initiators experienced numerical improvements in overall work impairment/activity impairment. This highlights tofacitinib effectiveness as monotherapy/combination therapy for a diverse PsA population. However, the small sample size limited the statistical power, and so results should be interpreted cautiously.

TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05195814.

PMID:41343116 | DOI:10.1007/s40744-025-00811-4

J Gastrointest Cancer. 2025 Dec 4;56(1):237. doi: 10.1007/s12029-025-01364-z.

ABSTRACT

BACKGROUND: Approximately 35% of patients do not receive adjuvant chemotherapy (AC) after surgery for stage III colorectal cancer (CRC). We aimed to investigate the association between receipt of AC and sociodemographic and treatment factors.

METHODS: A retrospective case-control analysis of patients with stage III CRC who underwent radical resection was performed using data from the SEER registry (2010-2020). The main exposure was socioeconomic determinants, and the main outcome was receipt of AC. Multivariable binary logistic regression analyses were used to assess independent predictors of AC receipt.

RESULTS: A total of 81,720 patients (52.4% male; median age, 65 years) were included. Overall, 70.6% of tumors were colonic and 29.4% rectal. 41.7% of patients did not receive AC. Independent socioeconomic determinants of AC receipt were age < 50 years (OR: 2.36, p < 0.001), male sex (OR: 0.931, p = 0.002), Black race (OR: 1.12, p = 0.002), Hispanic ethnicity (OR: 1.13, p < 0.001), household income <$50,000 (OR: 1.16, p = 0.001), non-metropolitan residence (OR: 1.09, p = 0.035), and unmarried status (single-OR: 0.778, p < 0.001, divorced-OR: 0.87, p < 0.001, widowed-OR: 0.313, p < 0.001). Tumor characteristics associated with AC receipt included tumor location and size, perineural invasion, number of positive lymph nodes, and CEA levels. Neoadjuvant chemotherapy (OR: 0.37, 95%CI: 0.28-0.48) and neoadjuvant radiation therapy (OR: 0.42, 95%CI: 0.38-0.46) were associated with lower odds of receiving AC in patients with colon and rectal cancer, respectively.

CONCLUSIONS: Receipt of AC was less likely among elderly males and those who received neoadjuvant treatments. Black and Hispanic patients and patients with low household income were more likely to receive AC.

PMID:41343095 | DOI:10.1007/s12029-025-01364-z