Nevin Manimala

Trials. 2026 Jan 17. doi: 10.1186/s13063-026-09434-8. Online ahead of print.

ABSTRACT

BACKGROUND: In Denmark, the current treatment of patients with symptomatic chronic subdural hematoma (CSDH) is single burr hole hematoma evacuation followed by 24-h passive subdural drainage. However, recent studies indicate that 24-h active subperiosteal drainage may be safer and have fewer recurrences. The upcoming SUPERDURA trial will investigate 24-h active subperiosteal drainage versus 24-h passive subdural drainage following single burr-hole evacuation of symptomatic CSDH. This study presents the statistical analysis plan for the SUPERDURA trial.

METHODS: SUPERDURA is a national multi-center non-inferiority randomized clinical trial. The primary outcome is a composite of 90-day mortality and ipsilateral recurrent CSDH requiring reoperation within the 90-day observation period. Secondary outcomes are 90-day simplified modified Rankin Scale questionnaire (smRSq) score, complications related to surgery, postoperative serious adverse events during the admission and at 90 days, and length of hospitalization. Exploratory outcomes are smRSq score as an ordinal outcome, each component of the primary outcome, and discharge destination. A total of 354 participants must be included (177 in each intervention group) in the study to achieve a stable power > 90% with an alpha of 5% for non-inferiority testing of the primary composite outcome with a margin at 7% absolute risk increase. The allocation sequence and block sizes are blinded to the investigators. Interim analyses for safety and efficacy/futility will be performed after follow-up is completed for 120 and 240 participants, respectively. A Data Safety Monitoring Committee charter has been created following published recommendations. Final analysis will be done by two statisticians blinded to the intervention, creating two abstracts that are unblinded once approved by the study steering committee.

DISCUSSION: The proposed analysis plan is designed in accordance with current guidelines, has clinically important primary and secondary outcomes, and was submitted before the inclusion of the first participant in the SUPERDURA trial to limit bias and increase study transparency and reproducibility.

TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT06621407.

PMID:41546119 | DOI:10.1186/s13063-026-09434-8

Syst Rev. 2026 Jan 17. doi: 10.1186/s13643-026-03074-4. Online ahead of print.

ABSTRACT

BACKGROUND: Chemotherapy-induced diarrhea (CID) is a common complication among colorectal cancer patients receiving chemotherapeutic treatment. This condition adversely affects therapeutic outcomes and potentially increases mortality risks. Acupuncture, an integral component of traditional Chinese medicine, has gained widespread use in China’s clinical settings. Recent findings suggest that this non-drug approach may provide therapeutic advantages for managing CID. This warrants further research into its clinical application.

METHODS: A comprehensive systematic review will be performed to find randomized controlled trials (RCTs) that examine the therapeutic effectiveness and safety of acupuncture treatments for managing CID in patients with colorectal cancer. The search strategy includes eight major electronic repositories: PubMed, Web of Science, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Biomedical Database (CBM), and China Scientific Journal Database (VIP), with no language restrictions. Primary endpoints focused on clinical improvements quantified through two key parameters: alterations in diarrhea severity according to the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) classifications, and modifications in episode duration. Secondary endpoints encompassed safety assessments of acupuncture-related adverse reactions and comprehensive evaluation of quality-of-life indicators using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Two reviewers will independently assess the risk of bias for all primary outcomes via the Cochrane Risk of Bias tool (RoB2). Disagreements will be resolved through discussion or third-party adjudication. For data synthesis and meta-analysis, all statistical analyses will utilize Review Manager software version 5.3 from the Cochrane Collaboration.

CONCLUSION: This systematic review will synthesize existing evidence to evaluate the therapeutic efficacy and safety of acupuncture in managing CID among colorectal cancer patients. The findings aim to inform clinical practice by assessing whether acupuncture represents a viable adjunctive therapy within evidence-based treatment protocols.

SYSTEMATIC TRIAL REGISTRATION: PROSPERO CRD420251045610.

PMID:41546113 | DOI:10.1186/s13643-026-03074-4

J Orthop Surg Res. 2026 Jan 17. doi: 10.1186/s13018-026-06669-8. Online ahead of print.

ABSTRACT

BACKGROUND/OBJECTIVE: Marginal impaction in acetabular posterior wall fractures significantly influences long-term prognosis, yet current assessment methods remain qualitative. This study introduces quantitative volumetric analysis using three-dimensional computed tomography to evaluate the prognostic significance of impaction volume-representing the first volumetric quantification of marginal impaction in the literature.

METHODS: Twenty-two patients with acetabular posterior wall fractures and marginal impaction treated between May 2021 and October 2023 at a tertiary trauma center were retrospectively analyzed. Preoperative computed tomography scans were processed using 3D Slicer-5.8.1 software to measure impacted fragment volumes and impaction volume-to-acetabular volume ratios. Functional outcomes were assessed using Harris Hip Score (HHS) and Modified Merle d’Aubigné-Postel Score (MMAS) at 6 months and 2 years. Statistical analysis included correlation analysis, receiver operating characteristic curves, and multivariate regression to identify prognostic factors.

RESULTS: Mean patient age was 45.3 ± 16.8 years (range 23-74) with mean body mass index of 26.4 ± 3.8 kg/m². Mean impaction volume was 1,847.3 ± 1,124.6 mm³ (range 89-3,842 mm³). Receiver operating characteristic curve analysis identified an exploratory threshold of 2000 mm³ for predicting poor functional outcomes, with area under the curve 0.91 (95% CI: 0.78-1.00, p < 0.001). Patients with impaction volumes > 2000 mm³ (n = 8, 36.4%) demonstrated significantly worse functional outcomes at 2 years compared to those with ≤ 2000 mm³ (HHS: 68.3 ± 10.8 vs 88.5 ± 7.2, p < 0.001; MMAS: 13.4 ± 2.3 vs 17.6 ± 1.2, p < 0.001). Post-traumatic osteoarthritis developed in 9 patients (40.9%), with significantly higher rates in the high-volume group (75.0% vs 21.4%, p = 0.012). Impaction volume showed strong negative correlation with functional scores at 2 years (HHS: r = -0.782, p < 0.001; MMAS: r = -0.758, p < 0.001). The impaction volume-to-acetabular volume ratio averaged 5.12 ± 3.15% and demonstrated similar prognostic value.

CONCLUSIONS: This study presents the first quantitative volumetric measurement of marginal impaction in acetabular fractures, which may offer improved prognostic discrimination compared to qualitative assessment in this cohort. An exploratory threshold of 2000 mm³, derived from receiver operating characteristic analysis, appears to stratify patients into different risk categories in this cohort for poor functional outcomes. This objective measurement tool may enhance surgical decision-making and patient counseling in acetabular fracture management. Future multicenter studies are needed to validate this threshold and establish standardized volumetric protocols.

PMID:41546103 | DOI:10.1186/s13018-026-06669-8

Breast Cancer Res. 2026 Jan 16. doi: 10.1186/s13058-025-02204-5. Online ahead of print.

ABSTRACT

BACKGROUND: In the years following pregnancy, breast cancer risk is elevated, particularly for hormone receptor negative (HR-) tumors. Exposure to high maternal circulating estrogens, when the breast is vastly remodeling in structure and morphology, has been associated with HR- tumor risk. Estrogen metabolite profiles in nonpregnant women, notably the ratio of 2:16 hydroxylation (OH) pathway metabolites, are associated with postmenopausal breast cancer development; whether estrogen metabolism during pregnancy influences subsequent HR- breast cancer risk is unknown.

METHODS: We conducted a population-based case-control study in women 19-39 years identified in the Finnish Maternity Cohort Biobank and linked with the Finnish Cancer Registry to identify breast cancer diagnoses within 20 years of pregnancy. Estrogens and metabolites were measured using highly reliable and sensitive LC-MS/MS methods in serum collected during the first and second trimesters of pregnancy. Included were invasive, ER-/PR- breast cancer cases (n = 449) and controls (n = 449) matched on maternal age at index pregnancy, parity, calendar year of serum collection, gestational week of blood collection, and number of sample freeze/thaw cycles. Associations between the estrogens and breast cancer risk were estimated using odds ratios (ORs) with 95% confidence intervals (CIs) from conditional logistic regression models.

RESULTS: The median years of follow-up between blood collection and breast cancer diagnosis/control selection was 9 (range 0-19). Ninety-three percent of cases were < 50 years of age at breast cancer diagnosis. Total estrogens were positively associated with ER-/PR- breast cancer (OR associated with a doubling of total estrogens 1.16; 95% CI 1.02-1.32), as were metabolites in the 16-pathway including estriol [OR 1.11; 95% CI 1.01-1.22], 16-epiestriol [OR 1.11; 95% CI 1.01-1.21)], 17-epiestriol [OR 1.06; 95% CI 1.01-1.13], and total 16-hydroxylation pathway metabolites [OR 1.11; 95% CI 1.00-1.24]. There was no clear association with the ratio of 2:16 hydroxylation pathway metabolites. Some associations differed by parity, age at diagnosis, and gestational timing of blood collection, but interactions were not statistically significant. Results were similar when restricted to cases occurring within 15 years since pregnancy.

CONCLUSION: This prospective study demonstrated positive associations of estrogen metabolites in pregnancy and risk of mostly premenopausal ER-/PR- breast cancer, but the magnitudes varied by metabolite. No strong or consistent pattern for one metabolic pathway emerged suggesting that total estrogen concentrations during pregnancy are associated with subsequent HR- breast cancer development, regardless of how they are metabolized.

PMID:41546058 | DOI:10.1186/s13058-025-02204-5

Scand J Trauma Resusc Emerg Med. 2026 Jan 17. doi: 10.1186/s13049-025-01542-9. Online ahead of print.

ABSTRACT

INTRODUCTION: In situ simulation (ISS) is a popular teaching method which uses simulated scenarios occurring in the actual clinical work environment of the learners. Our study aimed to compare the feasibility, safety, and identification of latent safety threats (LSTs) of two types of ISS in the Emergency Department (ED): announced and unannounced.

METHODS: We conducted a mixed method study at a Level-1 trauma center ED, using announced and unannounced ISS sessions. Research Assistants conducted semi-structured individual interviews to measure acceptability, implementation, and practicality. We also assessed implementation and patient safety using quantitative parameters (number of cancelled ISS sessions, ED wait times, patients who left without being seen, latent safety threats). We performed thematic content analyses for the qualitative data. Quantitative data were analysed using descriptive statistics and linear mixed-effects modelling.

RESULTS: In total, 84 emergency professionals participated in 18 simulations; 5 were unannounced and 13 were announced. Three main themes emerged from the interviews: the positive impact of ISS on patient safety, the preference for announced ISS, and the stress induced by ISS. The comparison of safety parameters showed no differences between both ISS modalities except for an increased number of patients leaving without being seen after unannounced ISS.

CONCLUSION: Our study found that both announced and unannounced in situ simulations are safe and practical for emergency medicine. They do not affect patient safety, or the number of latent safety threats. However, unannounced simulations were less feasible during a pandemic.

PMID:41546054 | DOI:10.1186/s13049-025-01542-9

BMC Surg. 2026 Jan 16. doi: 10.1186/s12893-026-03500-3. Online ahead of print.

ABSTRACT

INTRODUCTION: Firearm injuries continue to be a major cause of trauma-related morbidity and mortality worldwide. Abdominal firearm injuries are particularly critical due to the high risk of organ damage, hemorrhage, and sepsis. In trauma management, time to surgical intervention is considered one of the most decisive factors affecting survival. However, the evidence regarding the relationship between operating room (OR) access time and mortality remains inconsistent in the current literature.

AIM: This study aimed to evaluate the effect of the time to emergency surgery on mortality in patients presenting with isolated intra-abdominal firearm injuries. Additionally, it sought to identify clinical, hemodynamic, and organ-specific factors associated with early mortality.

METHODS: This retrospective study included 121 adult patients who presented to the Emergency Department of Adana City Training and Research Hospital between January 1, 2018, and July 31, 2024, with isolated intra-abdominal gunshot injuries and underwent emergency surgery. Demographics, comorbidities, vital signs, laboratory parameters, imaging findings, organ injuries, OR access times, and clinical outcomes were analyzed. Statistical comparisons were performed using appropriate parametric and non-parametric tests, with a significance threshold of p < 0.05.

RESULTS: Of the patients, 93.4% were male, and the median age was 34 years. The overall mortality rate was 6.6%. Mortality was significantly associated with chronic ischemic heart disease, colonic injury, and intra-abdominal vascular injury (p < 0.05). Non-survivors exhibited significantly lower blood pressure, hemoglobin, hematocrit, oxygen saturation, and pH levels and significantly higher heart rate, lactate, shock index, modified shock index, CK-MB, and hs-Troponin-I values (p < 0.05). Interestingly, time to the operating room was shorter in non-survivors (p = 0.002), reflecting more severe initial clinical presentation rather than improved outcomes.

CONCLUSION: In intra-abdominal firearm injuries, mortality is influenced more by the severity of organ damage and the patient’s hemodynamic condition at presentation than by OR access time alone. Early recognition of critical injuries, rapid resuscitation, and timely surgical intervention remain essential for improving survival outcomes. Clinical indicators such as lactate level, shock index, and hemodynamic parameters may serve as valuable predictors of early mortality.

PMID:41546051 | DOI:10.1186/s12893-026-03500-3

BMC Oral Health. 2026 Jan 17. doi: 10.1186/s12903-026-07660-9. Online ahead of print.

ABSTRACT

BACKGROUND: There has been a notable increase in artificial intelligence (AI) studies in dentistry. However, the inadequate use of proper validation methods has led to overly optimistic performance metrics of machine learning (ML) models. External validation provides evidence of a ML model’s performance with independent datasets and is crucial for generalizability.

METHODS: We developed Extreme Gradient Boosting (XGBoost) models to detect dental caries using easy-to-collect questionnaire data. ML model training was conducted using cross-validation nested resampling with a holdout test set, utilizing NHANES datasets (n = 6070). Performance of the trained model was tested using external data from the Northern Finland Birth Cohorts (NFBC1966 and NFBC1986; n = 3616). To enhance interpretability, beeswarm plots were constructed to visualize variable importance.

RESULTS: The ML model demonstrated acceptable performance in predicting dental caries on the internal dataset, with an area under the operating characteristics curve (AUC) of 0.785 (95% CI 0.756-0.813). However, the model encountered difficulties in identifying participants with dental caries, as shown by its poor sensitivity of 0.391, despite achieving a high specificity of 0.919. When applied to the external dataset, the ML model encountered significant challenges, with the AUC dropping to 0.550 (95% CI 0.532-0.569), sensitivity decreasing to 0.053, and specificity slightly improving to 0.974. Important variables identified by the model were self-rated condition of teeth and gums, presence of missing teeth, financial status, and time since last dental visit.

CONCLUSION: The performance of our ML model during external validation degraded notably compared to the internal validation. However, the XAI methodology exhibited great potential to be used in the future for individualized dental caries risk assessment.

PMID:41546040 | DOI:10.1186/s12903-026-07660-9

Biomed Eng Online. 2026 Jan 16. doi: 10.1186/s12938-025-01494-2. Online ahead of print.

ABSTRACT

BACKGROUND: Diabetic foot (DF) is a severe complication of type 2 diabetes mellitus (T2DM), contributing to significant morbidity and healthcare costs globally. Early prediction and intervention are critical for preventing amputations and improving patient outcomes. However, traditional statistical methods lack the capacity to handle high-dimensional clinical data and identify optimal predictive features. This study aimed to develop and validate machine learning models for DF risk prediction using feature selection strategies based on binary logistic regression and information theory.

METHODS: A retrospective cohort of 1,179 patients (95 DF cases, 1,084 T2DM controls) was analyzed using clinical and biochemical data from 2019 to 2025. Three data sets were constructed: (1) original features; (2) features selected via binary logistic regression (F1); and (3) features selected via information-theoretic global learning (F2). Six models-extreme learning machine (ELM), kernel extreme learning machine (KELM), and their variants trained on the three data sets-were evaluated using fivefold cross-validation. Performance metrics included area under the receiver operating characteristic curve (AUC), sensitivity, specificity, and computational efficiency.

RESULTS: Age, blood-urea-nitrogen (BUN), homocysteine (Hcy), albumin (ALB), and fasting blood glucose (FBG) were identified as independent DF risk factors. The information theory-based KELM (IT-KELM) model achieved the highest AUC of 0.799 (sensitivity: 0.792 and specificity: 0.710) on F2, outperforming other models. Feature selection improved predictive accuracy while reducing computational time, with IT-KELM requiring 0.138 s for training and 0.0023 s for testing. The SHAP summary dot plot and bar chart revealed that the top five features contributing to the model were TP, RBC, ALB, BMI and HB.

CONCLUSIONS: Integrating information theory with KELM enhances DF risk prediction by optimizing feature subsets and leveraging nonlinear kernel mapping. The IT-KELM model demonstrates robust diagnostic performance and clinical feasibility for early DF screening. Future multi-center studies are needed to validate generalizability and refine model interpretability in real-world settings. This approach provides a cost-effective tool for precision medicine in diabetes care.

PMID:41546000 | DOI:10.1186/s12938-025-01494-2

Head Face Med. 2026 Jan 16. doi: 10.1186/s13005-026-00587-0. Online ahead of print.

NO ABSTRACT

PMID:41545992 | DOI:10.1186/s13005-026-00587-0

BMC Nephrol. 2026 Jan 16. doi: 10.1186/s12882-025-04690-3. Online ahead of print.

ABSTRACT

BACKGROUND: Abnormal serum potassium levels are common among peritoneal dialysis (PD) patients. Many studies have shown hypokalemia as a risk factor for peritonitis, but most were cross-sectional and observational. We intended to analyze the longitudinal association between serum potassium levels and peritonitis in those undergoing PD.

METHODS: We included 1,288 patients undergoing regular PD at our institution. The endpoint event was peritonitis. Patients were divided into peritonitis and non-peritonitis groups. The relationship between baseline data and the emergence of peritonitis was analyzed through Cox regression analysis. Mixed-effects model was used to analyze the correlation between longitudinal serum potassium and other lab characteristics with peritonitis. Kaplan-Meier survival analysis estimated the median time to peritonitis.Independent samples t-test was used in subgroup analysis to explore the relationship between serum potassium and different pathogenic bacteria. Spearman correlation analysis and scatter plot were used to evaluate the correlation between serum potassium and magnesium. Cochran-Armitage trend chi-square test assessed the trend of peritonitis incidence.

RESULTS: COX regression analysis found higher baseline lymphocyte count and female gender were associated with lower peritonitis risk, while older age and higher baseline uric acid levels were linked to higher risk. A mixed-effects model indicated that the peritonitis group’s serum potassium decreased more rapidly and remained low longer. Kaplan-Meier curves estimated the median time to peritonitis to be 4.09 years. The analysis of subgroups found no significant difference in serum potassium levels between the gram-positive and gram-negative bacteria groups. Spearman correlation analysis showed a very weak positive correlation between potassium and magnesium with poor trend consistency but statistical significance. Peritonitis incidence showed a significant linear downward trend from 2011 to 2023.

CONCLUSIONS: Rapid declines and long-term low levels of serum potassium after PD initiation increase peritonitis risk. Long-term potassium management in PD patients is crucial in clinic practice, with intensified monitoring advised around 4 years into PD treatment.

TRIAL REGISTRATION: 2023BA0125_GC; 2023-10-20.

PMID:41545970 | DOI:10.1186/s12882-025-04690-3