Category: Statistics

Asian J Endosc Surg. 2025 Jan-Dec;18(1):e70004. doi: 10.1111/ases.70004.

ABSTRACT

INTRODUCTION: Due to the growing medical need for gynecologic robotic surgery, several robotic surgeries may be performed in a single day at high-volume centers. This study evaluated the safety of performing multiple robot-assisted hysterectomies (RAHs) per day by the same surgeon.

METHODS: We reviewed the clinical data of patients who underwent robotic surgery from April 2018 to September 2024 at the Department of Gynecology, Yamanashi Central Hospital, and also examined the surgical type, order, and surgeon for each procedure.

RESULTS: A total of 352 RAHs performed by the same surgeon were included. Among them, 267 were the first and second cases performed on the same day (Group A), and 85 were the third to fifth cases (Group B). There were no statistically significant differences between the two groups regarding age, body mass index, uterine weight, surgical indication, and history of abdominal surgery. The median operative time of 68 (35-179) min in Group A and 66 (37-187) min in Group B was similar (p = 0.141). Both groups also had similar estimated blood loss (p = 0.744). Each group had two perioperative complications, and no patient underwent conversion to open or laparoscopic surgery.

CONCLUSION: Performing multiple RAHs by the same surgeon in a single day may be a safe procedure with no negative impact on operative time, blood loss, or perioperative complications. Hence, it could be a useful treatment option for high-volume centers.

PMID:39707725 | DOI:10.1111/ases.70004

Int J Urol. 2024 Dec 20. doi: 10.1111/iju.15657. Online ahead of print.

ABSTRACT

BACKGROUND: The effectiveness of docetaxel in addition to next-generation androgen receptor-axis-targeted therapies and androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC) remains unclear. We evaluated the efficacy of this combination through tumor volume-specific analysis.

METHODS: Individual patient data were reconstructed from seven clinical trials focusing mHSPC (ARASENS, PEACE-1, TITAN, ENZAMET, ARCHES, STAMPEDE, and LATITUDE) through the Shiny method. Overall survival (OS), radiological progression-free survival (rPFS), and time to castration-resistant prostate cancer (CRPC) were analyzed in the overall cohort and tumor volume-specific (high/low) subgroups. Sensitivity analyses were performed based on treatment methods and metastasis onset.

RESULTS: In 6931 cases, adding docetaxel to ARAT and ADT did not significantly improve OS (hazard ratio [HR] = 1.07, 95% confidence interval [CI]: 0.95-1.22, p = 0.27), rPFS (HR = 0.88, 95% CI: 0.73-1.05, p = 0.16), or time to CRPC (HR = 0.97, 95% CI: 0.80-1.18, p = 0.74). High-volume disease showed a non-significant trend toward improved OS with the triplet regimen. Low-volume disease showed a similar trend. Sensitivity analyses for second-generation androgen receptor inhibitors indicated potentially less advantageous OS with docetaxel addition, but no significant differences when stratified by tumor volume. Analyses of the docetaxel-naïve, abiraterone, and synchronous metastasis subgroups showed no statistically significant differences in OS compared with the overall population and volume-stratified cases.

CONCLUSIONS: Patients with mHSPC did not show significant improvement with docetaxel addition to ARAT-based regimens, regardless of tumor volume. Further research is needed to identify potential beneficiaries of this combination therapy.

PMID:39707721 | DOI:10.1111/iju.15657

Pain Manag. 2024 Dec 20:1-8. doi: 10.1080/17581869.2024.2441650. Online ahead of print.

ABSTRACT

AIMS: Phantom limb pain (PLP) is a painful sensation occurring in patients around the site of an amputation. The aim of this systematic review is to evaluate the efficacy of cryoneurolysis in the management of phantom limb pain.

MATERIALS AND METHODS: A systematic review was performed according to the PRISMA 2020 guidelines. An initial search yielded 200 articles from four major scientific databases (PubMed, Embase, Cochrane Library, WebOfScience). Five articles met inclusion criteria, four of which underwent additional pooled statistical analysis.

RESULTS: Pooled analysis of the included trials revealed a cumulative Cohen’s d effect size of 1.55 (95% CI [0.24, 2.87]; p = 0.02; z = 2.32) for the reduction of pain on a 10-point pain scale following cryoneurolysis intervention. The remaining article that did not meet inclusion criteria for statistical analysis was a case report that reported a reduction in pain from 9/10 to 1/10 one week following intervention.

CONCLUSIONS: The large effect size demonstrated a statistically and clinically significant improvement in patient-reported pain. Additionally, patients may be able to reduce their amount of pharmaceutical pain management with successful cryoneurolysis treatment. However, these findings are limited by the small sample size and high heterogeneity between studies. Further high-quality studies should be performed to corroborate these findings.

PROTOCOL REGISTRATION: www.crd.york.ac.uk/prospero identifier is CRD42024543085.

PMID:39707720 | DOI:10.1080/17581869.2024.2441650

ACR Open Rheumatol. 2024 Dec 20. doi: 10.1002/acr2.11751. Online ahead of print.

ABSTRACT

OBJECTIVE: Prognostic factors associated with medication discontinuation in children with juvenile dermatomyositis (JDM) remain largely elusive. We aim to identify the predictors of medication-free remission (MFR) in children with JDM.

METHODS: In this retrospective study, patients diagnosed with JDM according to Peter & Bohan criteria and followed for ≥18 months at a tertiary care center from 2006 through 2022 were included. Data extracted included demographics, physical examination, laboratory results, and medications. MFR was defined as inactive JDM after discontinuation of all systemic immunosuppressives for ≥6 months, in line with international consensus guidelines for trials of therapies in idiopathic inflammatory myopathies. A two-sided P < 0.05 was considered statistically significant.

RESULTS: Of 55 patients with JDM (63.6% female, age median [interquartile range (IQR)] 6 [3.5-12] years), 29 (52.7%) achieved MFR after a median (IQR) of 33 (22.5-55.2) months. MFR was more common in those who were younger at JDM diagnosis (median 5 vs 8 years, P = 0.008), had early resolution of disease activity (median 11 vs 18 months, P < 0.001), and presented with Gottron papules (χ² = 5.25; P = 0.022) and elevated lactate dehydrogenase (χ² = 4.82, P = 0.028). Diagnosis of JDM before 5 years old (odds ratio 4.5, 95% confidence interval [CI] 1.2-16.7) was the only predictor of MFR in our multivariate model (area under the curve 0.65, 95% CI 0.53-0.76).

CONCLUSION: Half of our patients with JDM achieved MFR. Age at JDM diagnosis may be an important predictor of achieving MFR.

PMID:39707697 | DOI:10.1002/acr2.11751

Pharmacol Res Perspect. 2025 Feb;13(1):e70048. doi: 10.1002/prp2.70048.

ABSTRACT

Laboratory measurements used for safety assessments in clinical trials are subject to the limits of the used laboratory equipment. These limits determine the range of values which the equipment can accurately measure. When observations fall outside the measurable range, this creates a problem in estimating parameters of the normal distribution. It may be tempting to use methods of estimation that are easy to implement, however selecting an incorrect method may lead to biased estimates (under- or overestimation) and change the research outcomes, for example, incorrect result of two-sample test about means when comparing two populations or biased estimation of regression line. In this article, we consider the use of four methods: ignoring unmeasured observations, replacing unmeasured observations with a multiple of the limit, using a truncated normal distribution, and using a normal distribution with censored observations. To compare these methods we designed a simulation study and measured their accuracy in several different situations using relative error μ ̂ – μ μ $$ frac{hat{mu}-mu }{mu } $$ , ratio σ ̂ σ $$ frac{hat{sigma}}{sigma } $$ , and mean square errors of both parameters. Based on the results of this simulation study, if the amount of observations outside of measurable range is below 40%, we recommend using a normal distribution with censored observations in practice. These recommendations should be incorporated into guidelines for good statistical practice. If the amount of observations outside of measurable range exceeds 40%, we advise not to use the data for any statistical analysis. To illustrate how the choice of method can affect the estimates, we applied the methods to real-life laboratory data.

PMID:39707644 | DOI:10.1002/prp2.70048

Ann Noninvasive Electrocardiol. 2025 Jan;30(1):e70042. doi: 10.1111/anec.70042.

ABSTRACT

BACKGROUND: Exercise electrocardiogram (ECG) is frequently used for evaluating patients with suspected coronary artery disease (CAD). However, it has been downgraded in international guidelines due to a limited sensitivity and specificity, compared with other non-invasive tests.

METHODS: We hypothesized, that a sufficient exertion going beyond 85% of the age predicted maximal heart rate (APMHR), by considering the achieved level of workload can improve sensitivity and specificity of the exercise ECG. Secondly, the performance of exercise ECG, when evaluated against a functional reference standard has barely been investigated, although an improved diagnostic accuracy has been reported for other non-invasive tests in this case. Therefore, in this pilot study, a total of 147 patients without known CAD who underwent exercise ECG followed by coronary angiography within 90 days were retrospectively evaluated.

RESULTS: The combined end point of 85% of APMHR and 75% of the predicted workload showed a slight but not statistically significant benefit over APMHR alone (66.7% vs. 58.1%; p = 0.545). The sensitivity of ST-segment depression was 51.3% for detecting anatomically defined CAD and 62.5% for functionally relevant CAD (p = 0.378).

CONCLUSIONS: Although the results of this pilot study lack statistical significance, the numeric differences clearly justify further research on this topic.

PMID:39707636 | DOI:10.1111/anec.70042

J Diabetes Investig. 2024 Dec 20. doi: 10.1111/jdi.14387. Online ahead of print.

ABSTRACT

OBJECTIVE: This ACTION-IO sub-analysis compared attitudes of people with obesity (PwO) and healthcare professionals (HCPs) between South Korea/Japan and global.

METHODS: Responses from overall (body mass index [BMI] ≥ 25 kg/m²) and higher BMI (30.0-34.9 kg/m²) groups were compared descriptively; t-and z-tests were used to test for statistical significant difference.

RESULTS: Total responses from South Korea/Japan vs global were as follows: overall (PwO: 3,501 vs 14,502; HCPs: 502 vs 2,785); higher BMI (PwO: 530 vs 7,460) groups. Compared to global, more South Korea/Japan-PwO considered improving existing health condition as top weight loss (WL) goal (overall: 37% vs 28%, higher BMI: 35% vs 26%; P < 0.05) and fear of weight regain as top WL barrier (overall: 52% vs 45%, higher BMI: 65% vs 42%; P < 0.05). Fewer South Korea/Japan-PwO reported discussing weight (overall: 25% vs 51%, higher BMI: 31% vs 54%; P < 0.05). More South Korea/Japan-HCPs felt PwO as themselves responsible for WL (74% vs 55%; P < 0.05). More than two-of-three South Korea/Japan-HCPs (vs four-of-five global) were motivated to help PwO in WL.

CONCLUSIONS: South Korea/Japan PwO had differences in their attitudes and behaviors toward obesity care. These findings support the need for increased public awareness of obesity as a disease and for HCPs to play active role initiating weight management dialogue.

PMID:39707629 | DOI:10.1111/jdi.14387

Int J Cancer. 2024 Dec 20. doi: 10.1002/ijc.35310. Online ahead of print.

ABSTRACT

This study evaluates the H2AX/γ-H2AX expression in soft tissue sarcomas (STS), its implications for biological behavior and immune environment, and its potential as a prognostic biomarker. RNA-Seq data from 237 STS were obtained from The Cancer Genome Atlas project. Patients were stratified by H2AX mRNA expression using a survival-associated cutoff. Differentially expressed genes and pathways as well as immune signatures between H2AX^high– and H2AX^low tumors were identified with DESeq2 analysis, gene set enrichment analyses (GSEA), Enrichr pathway analysis and CIBERSORTx. Tissue microarrays of a different cohort of 291 STS were generated for immunohistochemical staining to assess γ-H2AX protein expression, followed by statistical evaluation. High H2AX mRNA expression was associated with shorter overall survival (OS) in STS (p = 0.02), particularly in leiomyosarcomas (LMS) (p < 0.001), and was a negative prognostic factor in LMS (HR 11.15, p < 0.001). H2AX^high LMS tumors showed upregulation of cell cycle-related pathways, while H2AX^low LMS exhibited increased inflammatory activity, including elevated M1 macrophage signatures and resting mast cell signatures (both p < 0.001). High γ-H2AX protein levels were an independent negative prognostic factor in the total LMS cohort (HR 12.12, p = 0.025) and in the subgroup of non-uterine LMS (HR 153.80, p = 0.013). Consistent with CIBERSORTx analysis, γ-H2AX^low LMS showed higher mast cell infiltration than γ-H2AX^high LMS (p = 0.038). In conclusion, H2AX mRNA and γ-H2AX protein expression are associated with distinct biological behavior, differences in the immune cell environment, and might serve as useful prognostic biomarkers in LMS.

PMID:39707602 | DOI:10.1002/ijc.35310

JDR Clin Trans Res. 2024 Dec 20:23800844241308149. doi: 10.1177/23800844241308149. Online ahead of print.

ABSTRACT

INTRODUCTION: Black children in the United States have lower rates of dental visits and higher rates of poor oral health. However, few studies have examined the role of structural racism as a contributor to racial gaps in children’s oral health. This study assessed associations between state-level structural racism and oral health outcomes of children and the related Black-White disparities.

METHODS: This repeated cross-sectional observational study examined children aged 1 to 17 y in the 2016 to 2021 National Survey of Children’s Health (NSCH). Three outcomes were examined: utilization (dentist visit in past 12 mo), any oral health problem (difficulty in past 12 mo with bleeding gums, cavities, or toothaches), and oral health (teeth in excellent or very good condition). A state-level index was constructed to measure Black-White structural racism composed of 5 dimensions (judicial, educational, economic, political, and neighborhood segregation) and linked to the NSCH. Estimated population-weighted logit regression models were used to assess associations between the outcomes and race and structural racism, adjusting for demographics and socioeconomic status.

RESULTS: The dataset consisted of 98,423 Black (11%) or White (88%) children. Black children had relatively worse outcomes than White children did, with the largest difference observed for the children having teeth in excellent or very good condition (73% vs. 83%). State-level structural racism was not statistically significantly associated with a child receiving dental care, having any oral health problem, or having teeth in excellent or very good condition. US Black-White disparities in these outcomes were unchanged after adjustment for state-level structural racism.

CONCLUSIONS: Expanded efforts are needed to address US Black-White disparities in child oral health outcomes. State-level structural racism was not associated with these outcomes. Future research should explore whether findings change when examining these associations at a different geographic level and whether indices of structural racism should explicitly include items specific to health care access and child-specific institutional domains.

KNOWLEDGE TRANSFER STATEMENT: Black children in this US study had relatively worse oral health and were less likely to have a dental visit than White children were. Structural racism did not explain these disparities, which suggests the need for further research to study mechanisms driving these disparities and how to address them. Policy makers should consider policies that expand where care is delivered, who delivers care, and increase dentists’ Medicaid participation, strategies identified previously for reducing disparities.

PMID:39707588 | DOI:10.1177/23800844241308149

Cancer Imaging. 2024 Dec 20;24(1):170. doi: 10.1186/s40644-024-00814-4.

ABSTRACT

BACKGROUND: The complex interactions of the tumor micromilieu may be reflected by diffusion-weighted imaging (DWI) derived from the magnetic resonance imaging (MRI). The present study investigated the association between apparent diffusion coefficient (ADC) values and histopathologic features in uterine cervical cancer.

METHODS: In this retrospective study, prebiopsy MRI was used to analyze histogram ADC-parameters. The biopsy specimens were stained for Ki-67, E-cadherin, vimentin and tumor-infiltrating lymphocytes (TIL, all CD45 positive cells). Tumor-stroma ratio (TSR) was calculated on routine H&E specimens. Spearman’s correlation analysis and receiver-operating characteristics curves were used as statistical analyses.

RESULTS: The patient sample comprised 70 female patients (age range 32-79 years; mean age 55.4 years) with squamous cell cervical carcinoma. The interreader agreement was high ranging from intraclass coefficient (ICC) = 0.71 for entropy to ICC = 0.96 for ADCmedian. Several ADC-histogram parameters correlated strongly with the TSR. The highest correlation coefficient achieved p10 (r = -0.81, p < 0.0001). ADCmean can predict tumors with high TSR, AUC: 0.91, sensitivity: 0.91 (95% CI 0.77;0.96), specificity: 0.91 (95% CI 0.78;0.97). Several ADC-histogram parameters correlated slightly with the proliferation index Ki-67. No associations were found with TIL, E-Cadherin and vimentin. In well and moderately differentiated cancers, ADC histogram values showed stronger correlations with Ki-67 and TSR than in poorly differentiated tumors.

CONCLUSION: ADC values are strongly associated with tumor-stroma ratio. The ADC mean can be used to predict tumors with high TSR. Associations between histopathology and ADC values depend on tumor differentiation. ADC values show only weak associations with Ki-67 and none with TIL, vimentin and E-cadherin.

PMID:39707580 | DOI:10.1186/s40644-024-00814-4