Category: Statistics

Toxicol Sci. 2026 Jan 16:kfag001. doi: 10.1093/toxsci/kfag001. Online ahead of print.

ABSTRACT

A chronic bioassay investigating radiofrequency (RF) carcinogenicity, intentionally designed to be conducted simultaneously in Korea and Japan, using the same research protocol and experimental environment. The study aimed to assess the potential carcinogenicity of Code Division Multiple Access (CDMA)-modulated 900 MHz RF signals at a whole-body specific absorption rate (SAR) of 4 W/kg, which is the reference level of the international human safety guideline, and to verify the key findings from the National Toxicology Program (NTP) study at that SAR level. Two reverberation chamber systems were used for RF exposures, and the same study protocols were followed. Male Harlan Sprague-Dawley (Hsd: Sprague Dawley® SD®) rats were randomly assigned to cage-control, sham-exposed, or RF-exposed groups. The exposure started on gestational day 5 and lasted for 18 hours and 20 minutes each day, with 10-minute on/off cycles. The project included a 28-day toxicity study, a 2-year carcinogenicity study, and a 14-week genotoxicity test. Histopathological evaluations were conducted in a partially blinded manner. The results were independently analyzed and submitted separately based on each country’s research findings. In the Korean study, no statistically significant changes in tumor incidence or survival rates were observed. No significant RF-related effects were detected in the heart, brain, or adrenal glands. No changes in body temperature. Genotoxicity tests showed no evidence of DNA damage or mutation. In conclusion, the Korean part found that long-term exposure to CDMA-modulated 900 MHz RF was neither carcinogenic nor genotoxic at a SAR of 4 W/kg in male rats.

PMID:41546387 | DOI:10.1093/toxsci/kfag001

Gan To Kagaku Ryoho. 2025 Dec;52(13):1186-1188.

ABSTRACT

Previous studies have shown that intracorporeal anastomosis(IA)improves postoperative recovery. However, its short-term outcomes remain controversial in elderly patients. This study aimed to compare the short-term outcomes of IA versus extracorporeal anastomosis(EA)for minimally invasive right colectomy in elderly patients aged 80 years or older using a propensity score matching(PSM)analysis based on double centric cohort of patients with right colon cancer between April, 2020, and December, 2024. Initially, 97 patients were selected, including 49 IA patients. After PSM, 64 patients were compared. There was no statistically significant difference between IA and EA in terms of operative time and postoperative morbidity (6.2% in IA vs 12.5% in EA;p=0.67). The IA group had a longer resected distal margin length(130 vs 100 mm, p=0.04) and shorter length of stay(7.5 vs 10 days, p=0.02). This comparison shows several clinical outcomes advantages for the IA in minimally invasive right colectomy in elderly patients.

PMID:41546290

Am J Sports Med. 2026 Jan 16:3635465251403568. doi: 10.1177/03635465251403568. Online ahead of print.

ABSTRACT

BACKGROUND: Patellofemoral instability (PFI) is common in adolescents and may require surgical treatment. Patient-reported outcome scores (PROs) are frequently used to evaluate outcomes after treatment. Commonly used PROs for PFI include disease-specific Banff Patellofemoral Instability Instrument 2.0 (BPII 2.0) and region-specific measures such as the Kujala Anterior Knee Pain Scale (Kujala), Pediatric International Knee Documentation Committee Subjective Knee Form (Pedi-IKDC), and Knee injury and Osteoarthritis Outcome Score (KOOS).

HYPOTHESIS/PURPOSE: The study aimed to compare the performance of disease-specific and region-specific PROs in adolescents after PFI surgery, and to evaluate their sensitivity to change. It was hypothesized that disease-specific PROs would perform better than region-specific PROs.

STUDY DESIGN: Case series; Level of evidence, 4.

METHODS: The JUPITER (Justifying Patellar Instability Treatment by Early Results) study database was used to evaluate PROs in 256 adolescents (263 knees) aged ≤18 years who underwent surgical treatment for PFI. Four commonly used PRO scores were analyzed at baseline and at least 1 year postoperatively. Statistical analysis included comparisons between pre- and postoperative scores, calculation of minimal clinically important difference (MCID), correlations among the 4 scores, and evaluation of their sensitivity to change, floor effects, and ceiling effects.

RESULTS: The median age was 15 years. Isolated medial patellofemoral ligament reconstruction was the most common procedure. The mean BPII 2.0 scores were lower at baseline and postoperatively, and showed the most substantial change at 1-year follow-up. There was a moderate correlation between the BPII 2.0 and the Kujala, Pedi-IKDC, and KOOS scores, and a strong correlation among the latter 3 scores. All scores were more sensitive to change among those at the lower 50th percentile of baseline scores. The BPII 2.0 was the only PRO that did not exhibit ceiling effects at follow-up.

CONCLUSION: When comparing the performance of disease-specific (BPII 2.0) and region-specific (Kujala, Pedi-IKDC, and KOOS) PROs, the BPII 2.0 was found to be the most sensitive to change after PFI surgery in adolescents, and the only scale that did not have a ceiling effect at baseline and 1-year follow-up. There was a moderate correlation-and thus limited interchangeability-between the BPII 2.0 and the Kujala, Pedi-IKDC, and KOOS scores, both at baseline and at 1-year follow-up, and a strong correlation among the latter 3 knee-specific PROs. The BPII 2.0 should be considered the PRO of choice when evaluating adolescent patients with PFI.

PMID:41546179 | DOI:10.1177/03635465251403568

Early Interv Psychiatry. 2026 Jan;20(1):e70122. doi: 10.1111/eip.70122.

ABSTRACT

BACKGROUND: Adverse events and substance misuse are rarely examined together among people in early phase psychosis, although both are frequently examined in isolation given their high prevalence in this population. As a result, the frequency of the three-way overlap is unclear. Moreover, adverse events are often limited to childhood abuse and rarely include illness-related events (e.g., threatening hallucinations). This study aims to explore the overlap between these variables and provide a more detailed understanding of adversity in this population and their desire to disclose experiences.

METHODS: We surveyed 110 individuals aged 16-35 years with early phase psychosis about substance misuse, lifetime adverse events, disclosure of adverse events, and PTSD symptoms.

RESULTS: Nearly all participants (97.2%) had experienced at least 1 adverse event, recalling an average of 8 adverse events over lifetime (SD = 3.8). Over 22% met the cutoff for a probable PTSD diagnosis on a validated measure. Substance misuse was present in 67% of participants, often involving multiple substances (M = 2.7 substances, SD = 1.5), most commonly alcohol, cannabis, and tobacco. There was an overlap between early phase psychosis, substance misuse, and a history of at least 1 adverse event in 66.4% of the sample. Most participants (78.7%) had disclosed their adverse events to someone, and 72.7% expressed interest in speaking to a mental health professional about their experiences.

CONCLUSION: Adverse events and substance misuse commonly co-occur in early phase psychosis, and these results have important clinical ramifications for assessment and treatment in an early phase psychosis population.

PMID:41546178 | DOI:10.1111/eip.70122

J Vasc Access. 2026 Jan 16:11297298251378615. doi: 10.1177/11297298251378615. Online ahead of print.

ABSTRACT

BACKGROUND: The SPECTRA study compared first-attempt success between ultrasound-guided and conventional peripheral intravenous catheter (PIVC) insertion. This subanalysis evaluated the control group results to determine the number of puncture attempts until successful or failed venous device insertion, stratified according to the Adult Difficult IntraVenous Access Scale (A-DIVA).

METHODS: Secondary analysis of the SPECTRA randomized clinical trial (RCT). Patients from the control group who underwent PIVC insertion without ultrasound guidance were included and stratified as high risk or low/moderate risk according to the A-DIVA. Statistical comparisons between the groups were conducted on the number of puncture attempts, insertion failures, catheter dwell time, and clinical outcomes related to PIVC insertion.

RESULTS: Of all 84 patients analyzed, 35 were classified as high risk, and 49 as low/moderate risk; 53 (63.1%) were female, mean age 59 ± 16 years. The main reason for hospitalization was infection; high-risk patients experienced more punctures, with 20 (57%) undergoing four punctures, compared to only 8 (16%) of the low/moderate-risk group, p < 0.001; the overall success rate of PIVC insertion was 17 (48.5%) in high-risk patients versus 43 (88%) in low/moderate-risk patients. Insertion failure occurred in 18 (51.5%) high-risk versus 6 (12%) low/moderate-risk patients, p < 0.001; the high-risk group had a shorter PIVC dwell time: 3 (2-8) days versus 8 (2-8) days in low/moderate-risk group, p = 0.065; PIVC removal due to negative outcomes (obstruction, infiltration, accidental removal) was higher in high-risk patients: 32 (91%) versus 24 (49%), p < 0.001.

CONCLUSIONS: Patients classified as high risk in the A-DIVA scale required more puncture attempts, had shorter PIVC dwell times, and experienced more negative outcomes. Using technologies such as ultrasound is beneficial for patients at high risk of failure on the first attempt.

PMID:41546176 | DOI:10.1177/11297298251378615

J Genet Couns. 2026 Feb;35(1):e70164. doi: 10.1002/jgc4.70164.

ABSTRACT

Sponsored genetic testing is where a non-traditional payer (e.g., pharmaceutical company, patient advocacy group) covers the cost of diagnostic genetic testing for a qualified individual in exchange for patient data. Although previous research has shown the public is hesitant when sharing medical information with for-profit researchers, there has been little research on genetic counselor (GC) attitudes toward sponsored testing. This study used mixed methods to assess GCs’ awareness of and attitudes toward sponsored testing and perceived implications on informed consent processes. Board-certified GCs were eligible to complete an online survey. Respondents with experience ordering sponsored testing were invited to participate in a focus group. Descriptive statistics were performed for survey data. Qualitative data were iteratively analyzed using codebook thematic analysis. The survey was completed by 68 GCs, of which 97% were female, 41% had 1-4 years of GC experience, and 75% had experience ordering sponsored testing. 61% (n = 41/67) of survey respondents felt the advantages of sponsored testing outweigh the disadvantages, and that there are additional components of informed consent for sponsored testing compared with standard practice. Of those who completed the survey, 12 participated in one of four focus groups. Most focus group participants felt that the lack of monetary cost and insurance billing were advantages of sponsored testing, as they increased access to testing for their patients. Perceived disadvantages included lack of transparency surrounding data sharing practices and the inability to customize sponsored panels. Many focus group participants felt that additional components of informed consent should be discussed with the patient when ordering sponsored testing, such as secondary use of data and future contact for research contribution. The majority of focus group participants described that when discussing sponsored testing with patients, they offer multiple test options and use shared decision-making to explore patients’ perceptions of sponsored testing. Our study suggested that it is important for providers to thoughtfully approach conversations on sponsored testing.

PMID:41546168 | DOI:10.1002/jgc4.70164

Vet Clin Pathol. 2026 Jan 16. doi: 10.1111/vcp.70079. Online ahead of print.

ABSTRACT

BACKGROUND: The periparturient period in dairy cows is marked by negative energy balance (NEB), resulting in metabolic stress and an increased risk of postpartum diseases. Accurate assessment of NEB through blood β-hydroxybutyrate (β-OHB) levels is essential for effective herd management. Point-of-care (POC) devices, such as the CentriVet blood ketone monitoring system, offer a practical alternative to laboratory methods for measuring β-OHB.

OBJECTIVE: This study aimed to evaluate the diagnostic and analytical performance of the CentriVet blood ketone monitoring system compared to a laboratory reference method for measuring blood β-OHB concentration in postpartum dairy cattle.

METHODS: A total of 105 postpartum dairy cows from two farms were included. Blood samples were analyzed for β-OHB using both CentriVet and a reference enzymatic method. Passing-Bablok regression, Bland-Altman plots, and kappa statistics were used to assess agreement. Diagnostic accuracy metrics (sensitivity, specificity, PPV, NPV, and accuracy) were calculated at a cut-off value of ≥ 1.2 mmol/L. An optimized cut-off value was determined via ROC curve analysis.

RESULTS: CentriVet demonstrated a moderate correlation with the reference method (Spearman’s r = 0.701, p < 0.001). Passing-Bablok regression revealed proportional bias, and Bland-Altman analysis indicated a mean bias of -0.4 mmol/L. Diagnostic metrics at ≥ 1.2 mmol/L showed 100% sensitivity, 68.09% specificity, and 71.4% accuracy. ROC analysis yielded an optimized cut-off of > 1.5 mmol/L, improving specificity (95.7%) but reducing sensitivity (81.8%).

CONCLUSIONS: While CentriVet offers practical benefits, its diagnostic performance is limited for accurately identifying hyperketonemia in postpartum dairy cattle.

PMID:41546138 | DOI:10.1111/vcp.70079

Cancer Control. 2026 Jan-Dec;33:10732748251414200. doi: 10.1177/10732748251414200. Epub 2026 Jan 16.

ABSTRACT

IntroductionPediatric acute leukemia is the most common childhood malignancy and one of the leading causes of cancer-related mortality worldwide, particularly, in low- and middle-income countries (LMICs), where treatment abandonment remains a major barrier to survival. Geographic accessibility and socioeconomic conditions are recognized determinants, but their combined influence in Mexico remains understudied. This study evaluated the association between geographic accessibility, socioeconomic factors, and treatment abandonment among children with acute leukemia in south-central Mexico.MethodsA prospective cohort study was conducted in Oaxaca, Puebla, and Tlaxcala from 2021 to 2023, including 574 children under 18 years diagnosed with acute lymphoblastic or myeloid leukemia. Geographic accessibility was estimated using travel distance and time from patients’ residences to referral hospitals, calculated with ORS Tools in QGIS. Socioeconomic variables included public health insurance affiliation, parental education and occupation, and number of siblings. Treatment abandonment was defined per SIOP criteria as failure to initiate or discontinuation of treatment for ≥4 consecutive weeks. Multivariable logistic regression, adjusted for child’s sex, age, year of diagnosis, and leukemia subtype, was used to assess associations.ResultsTreatment abandonment occurred in 16.6% of patients. In multivariable analysis, lack of public health insurance (aOR = 2.83; 95% CI: 1.39-5.76; P < 0.01) and living ≥141 km from the hospital (aOR = 1.68; 95% CI: 1.02-2.74; P = 0.03) were significantly associated with abandonment. Other factors, including number of siblings, maternal education, and fathers’ occupation, were not statistically significant.ConclusionLack of public health insurance and greater distance to the hospital are key determinants of treatment abandonment in children with acute leukemia in south-central Mexico. Expanding insurance coverage, reducing indirect costs, and addressing geographic barriers are critical to improve treatment adherence and survival outcomes in this population.

PMID:41546129 | DOI:10.1177/10732748251414200

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