Category: Statistics

J Digit Imaging. 2023 Jun 16. doi: 10.1007/s10278-023-00863-4. Online ahead of print.

ABSTRACT

To evaluate the consistency in the performance of Artificial Intelligence (AI)-based diagnostic support software in short-term digital mammography reimaging after core needle biopsy. Of 276 women who underwent short-term (<3 mo) serial digital mammograms followed by breast cancer surgery from Jan. to Dec. 2017, 550 breasts were included. All core needle biopsies for breast lesions were performed between serial exams. All mammography images were analyzed using a commercially available AI-based software providing an abnormality score (0-100). Demographic data for age, interval between serial exams, biopsy, and final diagnosis were compiled. Mammograms were reviewed for mammographic density and finding. Statistical analysis was performed to evaluate the distribution of variables according to biopsy and to test the interaction effects of variables with the difference in AI-based score according to biopsy. AI-based score of 550 exams (benign or normal in 263 and malignant in 287) showed significant difference between malignant and benign/normal exams (0.48 vs. 91.97 in first exam and 0.62 vs. 87.13 in second exam, P<0.0001). In comparison of serial exams, no significant difference was found in AI-based score. AI-based score difference between serial exams was significantly different according to biopsy performed or not (-0.25 vs. 0.07, P = 0.035). In linear regression analysis, there was no significant interaction effect of all clinical and mammographic characteristics with mammographic examinations performed after biopsy or not. The results from AI-based diagnostic support software for digital mammography was relatively consistent in short-term reimaging even after core needle biopsy.

PMID:37326891 | DOI:10.1007/s10278-023-00863-4

Rheumatology (Oxford). 2023 Jun 16:kead281. doi: 10.1093/rheumatology/kead281. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate belimumab addition to standard of care (SoC) in patents with refractory Idiopathic Inflammatory Myopathy (IIM).

METHODS: We conducted a 40-week multicentre randomized, double-blind, placebo-controlled trial with 1:1 IV belimumab 10 mg/kg or placebo randomization and a 24-week open-label extension. Clinical responses were measured by the Definition of Improvement (DOI) and Total Improvement Score (TIS). Flow cytometry analyses were performed on available samples before randomization, at 24 and 60-64wk. Descriptive statistics, t test, Fisher’s exact test and ANOVA tests were used.

RESULTS: 17 patients were randomized, 15 received ≥ 5 doses of belimumab or placebo and were included in the intention -to-treat analysis. More belimumab patients vs placebo attained TIS ≥ 40 (55.5% vs 33.3%; p=NS) and achieved DOI (33.3% vs 16.7%; p = NS) at Wk40 and Wk64; mean TIS was similar among groups. Two patients achieved major responses (TIS= 72.5) after Wk40 in the belimumab arm, none in the placebo arm. No improvement in placebo arm after switching to the open label phase was observed. There was no steroid-sparing effect. No new safety signals were detected.Although total B-cells were not reduced, belimumab induced naïve B-cells depletion while enhancing memory B cells number and frequency.

CONCLUSION: The study did not meet the primary end point and no statistically significant differences were observed in clinical responses between arms. More patients achieved sustained TIS ≥ 40 and reached DOI. Most patients who received belimumab longer than 40 weeks had clinical improvement. Phenotypic changes in B cell populations were not associated with clinical responses.

CLINICAL TRIAL REGISTRATION NUMBER: Clinicaltrials.gov, https://clinicaltrials.gov/, NCT02347891.

PMID:37326854 | DOI:10.1093/rheumatology/kead281

Ophthalmologie. 2023 Jun 16. doi: 10.1007/s00347-023-01882-w. Online ahead of print.

ABSTRACT

PURPOSE: To determine the rate of enucleation in Germany and the impact that the COVID-19 pandemic may have had on its characteristics.

METHODS: The rates of enucleation in Germany during 2019 and 2020 were extracted from the diagnosis-related groups (DRG) registry using the operation and procedure classification system codes 5‑163.0 through 5‑163.23 and 5‑163.x. The data were statistically analyzed.

RESULTS: The number of enucleations showed a 16.6% reduction from 1295 cases in 2019 compared to 1080 cases in 2020 (p = 0.17). In both years men averaged 54.1% of cases. Patients older than 65 years represented 53% and 56% of cases in 2019 and 2020, respectively. The most common indication for enucleation in both years was phthisis bulbi (n = 373 and n = 307, respectively), accounting for 29.7% of the cases, followed by choroidal malignancies (24%). Enucleation with the simultaneous introduction of an alloplastic orbital implant into Tenon’s capsule represented the most common procedure (38.7% combined 2‑year average), followed by a sheathed variant (26.6%) and a bulbar implant made of nonabsorbable microporous material (16.8%), without a significant change between years. Enucleations without the introduction of an implant increased from 7.8% in 2019 to 11.1% in 2020 (p = 0.006). The proportion of patients undergoing a reoperation slightly increased from 5.6% to 8% (p = 0.018). Most procedures (65.6%) were performed in large (> 1000 beds) public hospitals.

CONCLUSION: Despite the decrease in the total number of procedures performed, the rate of enucleation in Germany was not significantly altered by the COVID-19 pandemic. The rate of enucleation without implants and reoperations significantly increased.

PMID:37326852 | DOI:10.1007/s00347-023-01882-w

J Pediatr Gastroenterol Nutr. 2023 Jul 1;77(1):121-125. doi: 10.1097/MPG.0000000000003791. Epub 2023 Apr 19.

ABSTRACT

Chronic hepatitis B viral (HBV) infection is associated with significant morbidity and mortality with endemic areas carrying most of the global burden of HBV disease. Current HBV screening rates in the United States are suboptimal. We aimed to improve HBV screening rates at regional family health centers serving high-risk refugee populations by 20% over 2 years. We used quality improvement (QI) methodology and implemented interventions providing electronic medical record (EMR)-enabled HBV screening tools within known clinical workflows. EMR tools captured country-of-origin data to identify persons from HBV-endemic regions with provision of a laboratory order set to ensure performance of appropriate HBV screening tests. The project was initiated prior to the COVID pandemic but continued during the pandemic with imposed social isolation measures. We nevertheless demonstrated 4 statistical process control chart shifts and achieved our QI smart aim. Further, we demonstrated a high HBV detection rate (8.2%-12.8%) among persons identified for screening.

PMID:37326849 | DOI:10.1097/MPG.0000000000003791

Transl Stroke Res. 2023 Jun 16. doi: 10.1007/s12975-023-01164-2. Online ahead of print.

ABSTRACT

Repulsive guidance molecule A (RGMa) is an inhibitor of neuronal growth and survival which is upregulated in the damaged central nervous system following acute spinal cord injury (SCI), traumatic brain injury, acute ischemic stroke (AIS), and other neuropathological conditions. Neutralization of RGMa is neuroprotective and promotes neuroplasticity in several preclinical models of neurodegeneration and injury including multiple sclerosis, AIS, and SCI. Given the limitations of current treatments for AIS due to narrow time windows to intervention (TTI), and restrictive patient selection criteria, there is significant unmet need for therapeutic agents that enable tissue survival and repair following acute ischemic damage for a broader population of stroke patients. In this preclinical study, we evaluated whether elezanumab, a human anti-RGMa monoclonal antibody, could improve neuromotor function and modulate neuroinflammatory cell activation following AIS with delayed intervention times up to 24 h using a rabbit embolic permanent middle cerebral artery occlusion model (pMCAO). In two replicate 28-day pMCAO studies, weekly intravenous infusions of elezanumab, over a range of doses and TTIs of 6 and 24 h after stroke, significantly improved neuromotor function in both pMCAO studies when first administered 6 h after stroke. All elezanumab treatment groups, including the 24 h TTI group, had significantly less neuroinflammation as assessed by microglial and astrocyte activation. The novel mechanism of action and potential for expanding TTI in human AIS make elezanumab distinct from current acute reperfusion therapies, and support evaluation in clinical trials of acute CNS damage to determine optimal dose and TTI in humans. A: Ramified/resting astrocytes and microglia in a normal, uninjured rabbit brain. B: Rabbit pMCAO brain illustrating lesion on right side of brain (red), surrounded by penumbra (pink) during acute phase post stroke, with minimal injury to left brain hemisphere. Penumbra characterized by activated astrocytes and microglia (region in crosshair within circle), with upregulation of free and bound RGMa. C: Elezanumab binds to both free and bound RGMa, preventing full activation of astrocytes and microglia. D: Elezanumab is efficacious in rabbit pMCAO with a 4 × larger TTI window vs. tPA (6 vs. 1.5 h, respectively). In human AIS, tPA is approved for a TTI of 3-4.5 h. Elezanumab is currently being evaluated in a clinical Ph2 study of AIS to determine the optimal dose and TTI (NCT04309474).

PMID:37326791 | DOI:10.1007/s12975-023-01164-2

Clin Pharmacol Ther. 2023 Jun 16. doi: 10.1002/cpt.2975. Online ahead of print.

ABSTRACT

Dipeptidyl peptidase-4 inhibitors (DPP-4i) interact with sulfonylureas to increase their risk of hypoglycemia. Our population-based study assessed whether intra-class pharmacologic heterogeneity among sulfonylureas (long- versus short-acting) and DPP-4i (peptidomimetic versus non-peptidomimetic) modifies this interaction. We conducted a cohort study using the UK’s Clinical Practice Research Datalink Aurum linked to hospitalization and vital statistics data. We assembled a cohort of patients initiating sulfonylureas (2007-2020). Using a time-varying exposure definition, we assessed the risk of severe hypoglycemia (hospitalization with or death due to hypoglycemia) associated with 1) concomitant use of long-acting sulfonylureas (glimepiride, glibenclamide) with DPP-4i compared to concomitant use of short-acting sulfonylureas (gliclazide, glipizide) with DPP-4i; and 2) concomitant use of sulfonylureas with peptidomimetic DPP-4i (saxagliptin, vildagliptin) compared to concomitant use of sulfonylureas with non-peptidomimetic DPP-4i (sitagliptin, linagliptin, alogliptin). Time-dependent Cox models estimated confounder-adjusted hazard ratios (HRs) with 95% confidence intervals (CIs). Our cohort included 196,138 sulfonylurea initiators. During a median follow-up of 6 years, 8,576 events of severe hypoglycemia occurred. Compared to concomitant use of short-acting sulfonylureas with DPP-4i, concomitant use of long-acting sulfonylureas with DPP-4i was not associated with the risk of severe hypoglycemia (adjusted HR, 0.87; 95% CI, 0.65-1.16). Compared to concomitant use of sulfonylureas with non-peptidomimetic DPP-4i, concomitant use of sulfonylureas with peptidomimetic DPP-4i was also not associated with the risk of severe hypoglycemia (HR, 0.96; 95% CI, 0.76-1.22). Intra-class pharmacologic heterogeneity did not modify the association between concomitant use of sulfonylureas (short- vs long-acting) and DPP-4i (peptidomimetic vs non-peptidomimetic) and the risk of severe hypoglycemia.

PMID:37326010 | DOI:10.1002/cpt.2975

J Periodontol. 2023 Jun 16. doi: 10.1002/JPER.23-0236. Online ahead of print.

ABSTRACT

BACKGROUND: Periodontal diseases can negatively impact the oral health related quality of life (OHRQoL) of pregnant women. This study investigates the association between maternal oral inflammatory load (OIL), sociodemographic characteristics, and the OHRQoL in postpartum women.

METHODS: In this cross-sectional study, breastfeeding mothers were recruited from St. Michael’s hospital, Toronto within 2-4 weeks postpartum. Mothers were categorized into “Normal/low” and “High” OIL groups based on the absolute counts of oral polymorphonuclear neutrophils (oPMNs). The Oral Health Impact Profile-14 questionnaire was used to assess the impact of the maternal OIL on the OHRQoL. Multiple linear regression analyses were performed to examine the association between maternal sociodemographic factors including age, marital status, education level, employment status, parity, and their OHRQoL.

RESULTS: Forty-seven mothers were included in this study. Mothers with high OIL reported higher impact on their OHRQoL (30%) than mothers with normal/low OIL (21%), but these differences were not statistically different. There was a negative relationship between the mother’s education level and the extent of impact of OHRQoL on the “physical pain” dimension (P<0.05), and between the mothers’ age and employment status and the “physical disability” dimension (P<0.05). A positive correlation was noted between multi-parity and the extent of impact of OHRQoL on the “physical disability” dimension (P = 0.009), and between the marital status and the “psychological disability” dimension (P<0.05).

CONCLUSION: This study highlighted the significant impact of sociodemographic characteristics on the OHRQoL of mothers, showcasing the importance of considering these factors when implementing targeted preventive dental care programs for mothers. This article is protected by copyright. All rights reserved.

PMID:37326008 | DOI:10.1002/JPER.23-0236

Physiother Res Int. 2023 Jun 16:e2028. doi: 10.1002/pri.2028. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Restricted dorsiflexion range of motion (DFROM) could impact dynamic balance in sports. This study aimed to investigate the relationship between dorsiflexion range of motion and the Y-Balance Test (YBT) in elite futsal players.

METHODS: Sixty-one asymptomatic male futsal players (mean age 26.57 (5.64) years, a mean body mass index of 25.40 (2.69) kg/m² ) were included. DFROM was measured by the weight-bearing lunge test (WBLT). DFROM data were obtained using smartphone-based motion capture. The Pearson correlation coefficient verified the correlation between the variables.

RESULTS: Dominant and nondominant leg ankle DFROM was significantly correlated with the anterior component of YBT (r = 0.27 and 0.51, respectively). The posteromedial component and the composite score of the YBT were also significantly correlated with nondominant leg ankle DFROM (r = 0.31 and 0.34, respectively)]. The other measures were not statistically significant. DFROM explained between 7% and 24% of the variation of the distances reached in the YBT.

CONCLUSION: Dorsiflexion range of motion measured by weight bearing lunge test is positively correlated with dynamic balance in futsal players.

PMID:37325995 | DOI:10.1002/pri.2028

Int J Technol Assess Health Care. 2023 Jun 16;39(1):e35. doi: 10.1017/S026646232300034X.

ABSTRACT

OBJECTIVE: To assess the clinical effectiveness of fluticasone furoate nasal spray (FFNS) versus placebo on nasal symptoms and safety in children with perennial allergic rhinitis (AR).

METHODS: A comprehensive review was conducted with data obtained from Medline and Embase databases up to April 2023. The population of interest was patients aged 2-12 years with perennial AR. The selection was limited to randomized controlled trials (RCTs), comparing FFNS with placebo. Outcomes of interest included the reflective total nasal symptoms scores (rTNSS) and safety. To assess the minimal clinically important difference for rTNSS, the Cohen’s guideline was used. If the pooled standardized mean difference (SMD) and the lower limit of the 95 percent confidence interval (CI) exceeded the threshold of -0.20, effects were considered clinically significant.

RESULTS: Three RCTs (959 pediatric patients) were selected. One study evaluated the short-term use of FFNS, another evaluated the long-term use of FFNS, and another evaluated both the short-term and long-term use of FFNS. FFNS produced a statistically significant reduction over placebo in rTNSS (SMD -0.18; 95 percent CI -0.35 to -0.01, p = 0.03) in long-term treatment studies, but not in short-term treatment studies. However, since the mean reduction did not reach the minimum clinically important difference (SMD -0.20), these results were considered clinically not relevant. Safety outcomes with FFNS were similar to placebo.

CONCLUSIONS: The currently available evidence suggests that FFNS, 110 μg once daily, compared to placebo, does not produce a meaningful clinical effect on nasal symptom in children with perennial AR.

PMID:37325979 | DOI:10.1017/S026646232300034X

Monaldi Arch Chest Dis. 2023 Jun 15. doi: 10.4081/monaldi.2023.2640. Online ahead of print.

ABSTRACT

Reflux asthma is an entity characterised by typical symptoms and in some cases is ‘silent’ and is more dangerous when associated with obesity and sleep apnoea syndrome. Its prevalence in the general population is high, as demonstrated by numerous studies listed below, and it is particularly a problem in the paediatric population; where, despite treatment by medical specialists, asthma symptoms are poorly controlled with a high risk of acute exacerbations. The aim of this clinical study is to show how the addition of a particular type of alginate (Deflux plus sachets) containing hyaluronic acid and melatonin at low doses administered over a prolonged period of six months, causes a reduction in vagal reflex stimulation of the oesophagus and pulmonary microaspiration reflexes by regulating lower oesophageal sphincter (LES) motility in asthmatic patients; improving the ACT score (asthma control test score). In the reported statistical analysis, ROC curves were performed for sensitivity and specificity for the analysed parameters, including the ACT score with statistically significant data p<0.0001. We conclude that the combination of conventional therapy for reflux asthma associated with alginates may improve the risk of acute asthma exacerbation and dynamic lung volumes.

PMID:37325973 | DOI:10.4081/monaldi.2023.2640