Categories
Nevin Manimala Statistics

Statistical Competence and Editorial Policies in Biomedical Publications

J Korean Med Sci. 2026 Jul 20;41(28):e286. doi: 10.3346/jkms.2026.41.e286.

ABSTRACT

Misuse of statistical methods in biomedical research remains widespread, undermining scientific integrity and public health. Flawed analyses can lead to misleading clinical guidelines, unnecessary treatments, or concealment of true treatment effects. Statistical errors often result from a structural training gap that affects the research process from study design to reporting, rather than from individual incompetence. Authors should be able to select appropriate measures of central tendency based on the data distribution, apply parametric and nonparametric tests correctly, use regression analyses with attention to statistical power and collinearity, and interpret P values in the context of confidence intervals. The growing number of retractions in statistics and the continued citation of retracted articles highlight the limitations of current peer-review processes. Statistical Package for the Social Sciences is the most widely used statistical software in health sciences research, while R/RStudio is gaining increasing adoption due to its open-source nature, analytical flexibility, and capacity for fully reproducible and transparent analyses. Software selection can significantly influence analytical outcomes due to differences in default algorithms. Therefore, full disclosure of software versions and procedures is essential for reproducibility. Integrating artificial intelligence-based tools into statistical workflows introduces risks, including output hallucination, a lack of algorithmic transparency, and unresolved accountability. These tools should not be used without internationally accepted validation guidelines. At the publisher level, employing statistical editors, enforcing open data-sharing policies, and adopting contributor role taxonomies such as Contributor Roles Taxonomy are the most effective structural interventions. Enhancing the statistical quality of biomedical literature requires coordinated, sustained efforts from all stakeholders in scientific communication.

PMID:42478255 | DOI:10.3346/jkms.2026.41.e286

Categories
Nevin Manimala Statistics

Association Between Health Literacy and Outpatient Expenditure in Korea

J Korean Med Sci. 2026 Jul 20;41(28):e65. doi: 10.3346/jkms.2026.41.e65.

ABSTRACT

BACKGROUND: Health literacy (HL) is increasingly recognized as a crucial determinant of healthcare utilization and costs. Despite its importance, empirical evidence on the relationship between HL and healthcare expenditures in South Korea is limited. This issue is particularly timely and relevant given the country’s rapidly rising outpatient expenditure.

METHODS: This study analyzed data from the Korea Health Panel Survey conducted in 2021 (n = 8,630) to examine the association between HL and outpatient healthcare costs. HL was measured using the Korean version of the Health Literacy Survey European Questionnaire 16 (range: 0-16) and categorized as high (≥ 13) or low (≤ 12). Outpatient expenditure was defined as the sum of insurance-covered payments, out-of-pocket spending, and non-covered services, excluding pharmaceutical costs. Expenditure data were log-transformed and analyzed using multivariable linear regression. Subgroup analyses by age group were conducted under the assumption that healthcare utilization patterns vary across age categories.

RESULTS: The results showed that individuals with high HL spent 8.6% less on outpatient care than those with low HL. Subgroup analyses further revealed that this association was statistically significant only among adults aged 65 years and older.

CONCLUSION: These findings provide evidence that higher HL is associated with reduced outpatient expenditures in South Korea, particularly in older populations. Therefore, promoting HL among older adults may represent an effective strategy for improving healthcare efficiency and mitigating the burden of rising outpatient costs.

PMID:42478249 | DOI:10.3346/jkms.2026.41.e65

Categories
Nevin Manimala Statistics

Safety of caffeine citrate in neonates with Congenital Heart Disease receiving continuous infusions of alprostadil

Cardiol Young. 2026 Jul 21:1-6. doi: 10.1017/S1047951125110901. Online ahead of print.

ABSTRACT

Neonates with ductal-dependent congenital heart disease (CHD) will receive a continuous infusion of a prostaglandin E1 analogue such as alprostadil prior to surgical correction. Alprostadil can cause apnoea, which may be mitigated in practice with the use of caffeine citrate. Caffeine citrate can lead to tachyarrhythmias, which could be detrimental in this patient population. The purpose of this study was to determine if the practice of utilising caffeine citrate in neonates with ductal-dependent CHD receiving continuous alprostadil infusions is safe. In this single-centre, retrospective, cohort study of neonates admitted to the congenital heart service from November 2017 to September 2024, patients were included if they had ductal-dependent CHD and a gestational age greater than or equal to 35 weeks. Neonates that received continuous infusion of alprostadil alone were compared to those that received alprostadil in addition to caffeine citrate. The primary outcome was the frequency of sustained tachycardia during treatment. Seventy-five patients were included for review in each cohort. The median number of incidences of sustained tachycardia per patient was 7 (interquartile range 1-20) in the alprostadil plus caffeine citrate group and 4 (interquartile range 0-18) in the alprostadil alone group (p = 0.293). Other arrhythmias during the treatment course were common and similar between each cohort. Utilising caffeine citrate was not associated with a statistically significant increased incidence of tachycardia in neonates with ductal-dependent CHD on alprostadil infusions at the University of Florida.

PMID:42478232 | DOI:10.1017/S1047951125110901

Categories
Nevin Manimala Statistics

Unified Multi-Class Electroencephalogram Artifact Recognition Using Machine Learning Classifiers

Int J Neural Syst. 2026 Jul 22:2750001. doi: 10.1142/S0129065727500018. Online ahead of print.

ABSTRACT

Artifacts are noisy signals that commonly contaminate electroencephalographic (EEG) recordings, mixing with underlying brain activity and degrading the quality of neurophysiological data. Previous research on epileptic Anomaly Detection has shown that this approach is also sensitive to unlabelled artifacts, often leading to an increased False Positive rate. While most methods focus on detecting or removing a single type of artifact, this work proposes a unified multi-class framework to classify several artifact types alongside normal and pathological brain activity within a recording using a single, simple Machine Learning classifier. A set of spectral, temporal and statistical features commonly associated with different artifact types is extracted. KNN and XGBoost classifiers are trained and evaluated under a cross-validation scheme. The results demonstrate strong performance for both models, achieving approximately 90% sensitivity across all classes while maintaining a 100% specificity. These findings highlight the effectiveness of a unified and interpretable approach for multi-class EEG artifact classification.

PMID:42478186 | DOI:10.1142/S0129065727500018

Categories
Nevin Manimala Statistics

Clinical trial landscape of cell therapy for spinal cord injury: from integrated practices to future developments

BMC Med. 2026 Jul 20. doi: 10.1186/s12916-026-05078-2. Online ahead of print.

ABSTRACT

INTRODUCTION: Spinal cord injury (SCI) precipitates a multiphasic secondary injury cascade that establishes a hostile, inhibitory microenvironment, rendering the condition refractory to conventional surgical stabilization and rehabilitation. While cell-based therapies offer promise for neural reconstruction, their clinical translation is impeded by protocol heterogeneity and fragmented safety data. To address this, we mapped clinical trials for SCI to quantify patient demographic parameters, identify lineage-specific adverse-event patterns, evaluate objective motor and sensory efficacy outcomes, and analyze methodological trial designs to formulate concrete structural recommendations for future advanced-phase trials.

METHODS: We analyzed clinical trials from the Web of Science Core Collection (SCIE and ESCI) published since 2005. The dataset comprised 116 eligible studies involving patients with SCI receiving cellular therapies with reported safety outcomes. We employed a dual-method approach combining manual extraction of clinical characteristics (demographics, interventions, adverse events, efficacy outcomes) with quantitative data analysis. Statistical associations between therapeutic variables (cell type, route, dosage) and safety profiles were evaluated using Fisher’s exact test.

RESULTS: The clinical landscape is predominantly defined by early-phase (Phase 1: 59.5%), single-arm investigations (63.8%) utilizing autologous bone marrow-derived cells. Reflecting a cautious paradigm to minimize severe complications, patient selection frequently targeted the hemodynamically stable chronic phase (58.3%) and thoracic SCI (21.6%). Safety analyses revealed lineage-specific profiles: mesenchymal stromal cells were significantly associated with transient fever (P = 0.038), whereas intrathecal administration correlated with procedural symptoms such as headache (P < 0.001). The observation of higher systemic adverse event rates in low-dose cohorts was likely confounded by the mandatory concurrent immunosuppressive regimens required for specific allogeneic lineages, rather than the absolute cell dose. Regarding therapeutic efficacy, outcomes were critically influenced by the chronological phase of injury. Patients treated in the acute or subacute phases exhibited higher rates of neurological improvement, though distinguishing this from spontaneous recovery remains challenging, whereas chronic phase interventions demonstrated more limited primary sensorimotor gains. Additionally, intrathecal administration showed an advantage in preserving sensory pathways due to minimized structural disruption, while dose requirements could not be generalized and varied fundamentally based on specific cellular mechanisms of action.

DISCUSSION: While the baseline safety of cellular transplantation for spinal cord injury is established, clinical translation remains hindered by methodological heterogeneity, imprecise patient stratification, and a reliance on single-arm trial designs. To navigate this translational bottleneck, future investigations should adopt multi-tiered methodological frameworks. First, study designs should transition toward controlled protocols, utilizing crossover designs for chronic cohorts and matched historical or synthetic controls for acute and subacute phases. Concurrently, patient selection must evolve from broad clinical grading to advanced stratification. Integrating biomarkers, electrophysiology, and imaging to objectively quantify tissue sparing can better identify responsive subgroups, thereby improving trial efficiency and accelerating clinical translation. Beyond cohort refinement, intervention parameters, specifically dosage and delivery routes, should be individualized according to cell lineage, as adverse events associate more with intrinsic cellular biology and procedural invasiveness. Furthermore, isolating the true therapeutic effect requires the standardization and reporting of confounding variables, such as immunosuppressive regimens and physical rehabilitation. Finally, by separating shorter-term efficacy measurements from long-term safety registries, the field can facilitate a more reliable and objective clinical translation.

PMID:42477724 | DOI:10.1186/s12916-026-05078-2

Categories
Nevin Manimala Statistics

Severe anemia and red cell product ordering burden among women hospitalized with benign uterine disorders: a retrospective cohort study using MIMIC-IV

BMC Womens Health. 2026 Jul 20. doi: 10.1186/s12905-026-04716-4. Online ahead of print.

ABSTRACT

BACKGROUND: Benign uterine disorders, including uterine leiomyomas and uterine endometriosis/adenomyosis-related conditions, are common causes of gynecologic morbidity and represent an important women’s health issue. Although these conditions are generally non-malignant, a subset of hospitalizations may involve substantial anemia-related clinical burden. Evidence describing severe inpatient anemia, red cell product ordering, intensive care unit (ICU) use, and short-term hospital outcomes in this population remains limited.

METHODS: We conducted a retrospective cohort study using hospital data from the Medical Information Mart for Intensive Care IV (MIMIC-IV). Adult female hospitalizations with diagnostic codes related to benign uterine disorders were identified. Hospitalizations with missing hemoglobin data, pregnancy- or obstetric-related diagnoses, and gynecologic malignancy-related diagnoses were excluded. The unit of analysis was hospitalization. Severe anemia was defined as a minimum inpatient hemoglobin level < 8 g/dL during hospitalization. The main outcome was red cell product ordering identified from Blood Bank provider order entry records, which was interpreted as a transfusion-related resource use indicator rather than confirmed red cell administration. Additional hospital burden outcomes included hospital length of stay, ICU admission during hospitalization, in-hospital mortality, and gynecologic procedure-related outcomes. Multivariable logistic regression was used to evaluate the association of severe anemia with red cell product ordering and ICU admission. Models were adjusted for age, race/ethnicity, insurance status, marital status, admission type, and disease group. Sensitivity analyses used hemoglobin < 10 g/dL as an alternative anemia threshold.

RESULTS: The final cohort included 1,860 non-obstetric, non-malignant hospitalizations with available hemoglobin data. Severe anemia was present in 425 hospitalizations (22.8%). Compared with hospitalizations without severe anemia, those with severe anemia had a higher proportion of red cell product orders (63.29% vs. 5.09%), longer hospital length of stay [3.436 (1.911-6.389) vs. 2.310 (1.335-3.816) days], and more frequent ICU admission during hospitalization (15.06% vs. 6.13%). In-hospital mortality was uncommon overall and was analyzed only exploratorily. After multivariable adjustment, severe anemia was associated with red cell product ordering [adjusted odds ratio (OR) 33.61, 95% confidence interval (CI) 24.23-47.29] and ICU admission during hospitalization (adjusted OR 2.69, 95% CI 1.84-3.91). In the fibroid-only subgroup, the corresponding adjusted ORs were 35.55 (95% CI 24.96-50.64) for red cell product ordering and 2.68 (95% CI 1.83-3.92) for ICU admission. Sensitivity analyses using hemoglobin < 10 g/dL showed directionally consistent findings. Additional sensitivity analyses using earlier hemoglobin definitions showed that early 24-hour Hb < 8 g/dL remained strongly associated with red cell product ordering (adjusted OR 22.57, 95% CI 15.54-32.80), whereas the corresponding ICU admission estimate was attenuated and not statistically significant (adjusted OR 1.09, 95% CI 0.66-1.80).

CONCLUSIONS: Among women hospitalized with benign uterine disorders, severe inpatient anemia was common and was associated with greater red cell product ordering and higher hospital resource use. These findings suggest that severe inpatient anemia may serve as a practical marker of anemia-related hospital burden in this defined hospitalized population, while ICU-related findings and causal interpretation require caution.

PMID:42477721 | DOI:10.1186/s12905-026-04716-4

Categories
Nevin Manimala Statistics

Comparison of vaginal natural orifice transluminal endoscopic surgery and multiport conventional laparoscopy for complete pelvic lymphadenectomy: Insights from a single-surgeon experience

BMC Womens Health. 2026 Jul 20. doi: 10.1186/s12905-026-04698-3. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: We compared the outcomes of complete pelvic lymph node dissection performed via multiport conventional laparoscopy (MCL) versus vaginal natural orifice transluminal endoscopic surgery (vNOTES) in patients with endometrial cancer in whom sentinel lymph node (SLN) mapping was unsuccessful.

METHODS: This retrospective cohort study included 42 patients with grade I or II endometrioid endometrial cancer who underwent hysterectomy with bilateral salpingo-oophorectomy, followed by comprehensive retroperitoneal pelvic lymphadenectomy after failed bilateral SLN mapping. Patients underwent either vNOTES (n = 21) or MCL (n = 21). Demographic characteristics, operative times, perioperative and postoperative complications, pain scores, and quality of recovery-15 (QoR-15) scores were collected and compared between the two groups.

RESULTS: Demographic and clinical characteristics were comparable between the two groups, with no statistically significant differences. Operative times were significantly longer in the vNOTES group (53.8 ± 7.4 min) compared to the MCL group (46.9 ± 9.2 min; P = 0.01), whereas estimated blood loss (17.7 ± 5.6 mL vs. 18.8 ± 5.0 mL; P = 0.50) and lymph node yield (32.1 ± 6.6 vs. 35.0 ± 8.1; P = 0.21) did not differ significantly. Postoperative pain assessed by visual analogue scale (VAS) was lower in the vNOTES group at 6 h (4.3 ± 1.1 vs. 5.5 ± 1.0; P = 0.01), 12 h (3.5 ± 0.8 vs. 4.8 ± 1.1; P < 0.001), and 24 h (2.1 ± 0.6 vs. 3.1 ± 0.9; P < 0.001). These findings were corroborated by the faces pain scale-revised (FPS-R), which demonstrated significantly lower pain in the vNOTES group at all time points. QoR-15 scores at 48 h were higher in the vNOTES group (109.3 ± 4.7 vs. 104.9 ± 4.1; P = 0.002), indicating improved postoperative recovery. The observed mean difference of approximately 4.4 points remained below the reported minimal clinically important difference of 8.0 points for this instrument, indicating that the statistically significant benefit should be interpreted with caution regarding its clinical magnitude.

CONCLUSION: vNOTES for complete pelvic lymphadenectomy offers reduced postoperative pain, scar-free surgery, and enhanced recovery while maintaining staging adequacy comparable to MCL. Future prospective, multicentre, randomised trials with long-term oncologic follow-up are required to validate these findings.

PMID:42477715 | DOI:10.1186/s12905-026-04698-3

Categories
Nevin Manimala Statistics

Association of vaginal dysbiosis with cervical lesions among women with non-16/18 high-risk HPV infections: a cross-sectional study of 2,264 women in Eastern China

BMC Womens Health. 2026 Jul 20. doi: 10.1186/s12905-026-04714-6. Online ahead of print.

ABSTRACT

BACKGROUND: To investigate whether vaginal dysbiosis is associated with an increased risk of cervical lesions infected with non-16/18 high-risk human papillomavirus (HR-HPV) genotypes and to inform risk-stratified cervical cancer screening strategies.

METHODS: This cross‑sectional study included 2,264 women attending Jiaxing Maternal and Child Health Hospital between June 2023 and October 2024. HPV genotyping, vaginal microecological assessment, and Thinprep cytologic test (TCT) were performed. HR- HR-HPV infections were classified as HPV16/18-positive or non-16/18 HR-HPV infections. Logistic regression models were used to evaluate associations, adjusting for age. Multiplicative interaction was assessed using Wald tests for product terms. Benjamini‑Hochberg FDR correction was applied for multiple comparisons.

RESULTS: The overall HPV prevalence was 49.87%, with HR-HPV detected in 36.13%. HR‑HPV infection was significantly associated with cervical lesions in both normal (OR = 11.45) and dysbiotic (OR = 4.40) vaginal microbiota (both P < 0.001). Stratified analyses showed higher point estimates for HPV58 and HPV59 in the dysbiosis group (OR = 10.98 and 9.51, respectively) than in the normal group (OR = 7.50 and 6.44, respectively). However, formal multiplicative interaction tests did not reach statistical significance (Wald P = 0.526 and 0.559, respectively; FDR‑adjusted q = 0.559 for both). No HPV subtype remained significantly associated with ASC‑US after FDR correction.

CONCLUSIONS: In this cross‑sectional study, vaginal dysbiosis is specifically associated with cervical lesions among women with non‑16/18 HR‑HPV infections, particularly HPV58 and HPV59, which showed elevated point estimates in the presence of dysbiosis. However, formal multiplicative interaction tests did not reach statistical significance. These findings are exploratory and hypothesis‑generating; causality cannot be inferred due to the cross‑sectional design. Prospective studies are needed to validate the observed associations before any clinical application can be considered. Our results should be interpreted with caution and do not support changes to current screening practice.

PMID:42477712 | DOI:10.1186/s12905-026-04714-6

Categories
Nevin Manimala Statistics

Incidence, risk factors and tumor spectrum of second primary cancers after gastric cancer: a multicenter cohort study with long-term follow-up

BMC Med. 2026 Jul 20. doi: 10.1186/s12916-026-05018-0. Online ahead of print.

ABSTRACT

BACKGROUND: The development of second primary cancers (SPCs) has become an important late effect in gastric cancer (GC) survivors, yet its incidence, risk factors, and clinical implications remain poorly defined. This study aimed to evaluate the long-term risk of SPCs, identify clinical factors associated with SPC occurrence, and describe detection patterns and stage distribution of SPCs during long-term follow-up.

METHODS: Patients with GC who underwent curative-intent radical gastrectomy between 2007 and 2021 were identified from the Multidisciplinary Alliance of Gastric Integrative Studies (MAGIS) cohort. Clinical factors associated with SPC occurrence were selected using LASSO-penalized Cox regression, and exploratory risk-based stratification was performed. Stage distribution was descriptively compared between SPCs detected during asymptomatic surveillance and those diagnosed after symptom onset.

RESULTS: Among 11,027 GC survivors (8,519 men and 2,508 women), 241 (2.19%) developed SPCs during a follow-up of up to 16 years. The cumulative incidence of SPCs was 1.25% (95% CI, 1.03%-1.46%) at 5 years, 2.97% (95% CI, 2.55%-3.39%) at 10 years, and 4.15% (95% CI, 3.40%-4.91%) at 15 years after gastrectomy. The most frequent SPCs were lung (23.2%), colorectal (21.6%), and esophageal (12.9%) cancers, showing marked sex-specific differences: lung cancer predominated in males, whereas cervical cancer was most common in females. Factors associated with SPC occurrence included older age at time of gastrectomy (HR 1.04, 95% CI 1.02-1.05; p < 0.001), chronic HBV/HCV infection (HR 2.15, 95% CI 1.29-3.58; p = 0.003), family history of cancer (HR 1.57, 95% CI 1.16-2.12; p = 0.003), and elevated preoperative systemic inflammation (Log-SIRI; HR 1.86, 95% CI 1.31-2.65; p < 0.001). The derived model stratified patients into low-, intermediate-, and high-risk groups with corresponding 10-year SPC risks of 2.07%, 3.61%, and 4.33%. SPCs detected during asymptomatic surveillance were more frequently diagnosed at stage I than those identified after symptom onset (47.4% vs 17.6%; p < 0.001).

CONCLUSIONS: SPCs represent an important long-term health burden among GC survivors, with distinct sex-specific disease patterns. The exploratory risk-scoring model showed preliminary risk stratification, and SPCs detected during asymptomatic surveillance were more often diagnosed at an earlier stage. These findings support further evaluation of risk-adapted, organ- and sex-specific surveillance strategies in methodologically rigorous studies.

PMID:42477705 | DOI:10.1186/s12916-026-05018-0

Categories
Nevin Manimala Statistics

Economic burden and return on investment of immunization programs in Saudi Arabia: a health economic evaluation

BMC Public Health. 2026 Jul 20. doi: 10.1186/s12889-026-28633-1. Online ahead of print.

ABSTRACT

BACKGROUND: Vaccine-preventable diseases (VPDs) continue to impose a significant health and economic burden globally, despite advances in immunization programs. Narrower to the context of Saudi Arabia, the current literature consistently shows that the high vaccination coverage has had the primary impact of reducing disease incidence. Regardless, the broader economic impact of VPDs and the financial benefits of immunization remain important for policy evaluation within Saudi Arabia.

METHODS: This study employed a model-based economic evaluation using a societal perspective in order to carry out an estimation of the economic burden of measles, influenza, and pneumococcal diseases. We utilized the Cost of Illness (COI) approach for the purpose of quantifying direct medical costs and indirect productivity losses. On the other hand, the Value of Statistical Life (VSL) approach helped in the estimation of the monetary value of mortality reduction. A comparative framework analyzed current vaccination coverage against a counterfactual no-vaccination scenario for the calculation of the return on investment (ROI).

RESULTS: The estimated annual economic burden of the three selected VPDs in the absence of vaccination was USD 385 (95% CI: 315-460) million. Immunization programs generated substantial economic benefits, with total benefits estimated at USD 1085 (95% CI: 815-1360) million annually. The calculated ROI was 9.85 (95% CI: 6.8-11.3), essentially an indication that for each dollar invested in vaccination, there was multiple economic returns yielded. Sensitivity analyses confirmed the robustness of these findings.

CONCLUSION: Immunization programs in Saudi Arabia provide significant economic and public health benefits and for this reason, sustained investment in vaccination is fundamentally essential towards the reduction of disease burden, improve population health, and ultimately support long-term economic productivity.

PMID:42477699 | DOI:10.1186/s12889-026-28633-1