Category: Statistics

Drug Saf. 2024 Dec 8. doi: 10.1007/s40264-024-01502-9. Online ahead of print.

ABSTRACT

BACKGROUND: Proton pump inhibitors (PPIs) are among the most popular drugs worldwide. Yet, there are concerns on long-term safety and poor adherence to prescription guidelines. Off-label use in children and increasing maintenance use in older adults may be particularly worrisome.

OBJECTIVES: To assess differences in PPI use by age, sex calendar year and PPI type, and to explore potential underlying indications (ulcerogenic drugs, and indications) in Sweden.

METHODS: Proton pump inhibitor drug utilisation study based on the Swedish nationwide prescribed drug (2006-2023) and patient registries (2006-2022).

RESULTS: Proton pump inhibitors were used by 14.4% (women) and 10.5% (men) of adults; and 1.0-1.5% of children and adolescents (aged < 20 years). Proton pump inhibitor use was higher in women in all age-groups except small children (aged < 5 years). Proton pump inhibitor use has increased in all age groups, especially in young children (aged < 10 years) and the oldest groups (aged > 65 years). Proton pump inhibitor users aged > 85 years filled most prescriptions with an annual average of 9.5 (men), 11.6 (women) prescriptions. Most prescriptions were for omeprazole and esomeprazole: 63.7% and 23.5% in adults; 23.5% and 44.7% in children (2023). Prescriptions for other drugs for peptic ulcers/reflux became rare, with 99% of prescriptions in this category being PPIs by 2023. Gastro-intestinal diagnoses were predominantly recorded in men, became less prevalent and only explained part of PPI use, while ulcerogenic drugs were common (particularly in women), suggesting PPIs are regularly used for gastroprotection.

CONCLUSION: Proton pump inhibitor use has doubled in children and increased 50% in adults over the study period, in both sexes, while recorded gastrointestinal indications decreased. Alternative therapies were rarely prescribed in Sweden.

PMID:39645619 | DOI:10.1007/s40264-024-01502-9

Ann Noninvasive Electrocardiol. 2025 Jan;30(1):e70032. doi: 10.1111/anec.70032.

ABSTRACT

INTRODUCTION: Early repolarization (ER) is an electrocardiographic pattern characterized by J-point and ST-segment elevation, frequently observed in athletes. Initially deemed benign, recent studies suggest a possible association between ER and increased risks of cardiac arrhythmias and sudden cardiac death, necessitating a thorough examination of its clinical implications in athletes.

METHODS: A comprehensive literature review was conducted using MEDLINE (via PubMed) and EMBASE databases, focusing on articles related to ER in athletes. Search terms included “early repolarization,” and relevant studies were selected based on their focus on athletic populations. A total of 22 articles were included for detailed analysis.

RESULTS: The review encompassed 22 studies with a combined total of 44,326 athletes, revealing an overall mean ER prevalence of 31.6 ± 17.6 (p < 0.001). Most common location in the inferolateral region at 32.28%. The prevalence varied significantly across studies, ranging from 7% to 89%, influenced by factors such as age, gender distribution, and athletic discipline. Male athletes exhibited a higher incidence of ER compared with females, and endurance athletes showed a greater prevalence than strength athletes.

CONCLUSION: ER is notably prevalent among athletes, especially males and those engaged in endurance sports. Current studies do not establish a direct association between ER and increased mortality in athletes. Further research is essential to refine risk stratification criteria and develop appropriate management strategies to ensure athlete safety while maintaining optimal performance levels.

PMID:39645598 | DOI:10.1111/anec.70032

Ann Noninvasive Electrocardiol. 2025 Jan;30(1):e70031. doi: 10.1111/anec.70031.

ABSTRACT

QT/QTc prolongation is associated with an increased risk for torsade de pointes. In at-risk hospitalized patients, it is common to obtain a standard 12-lead electrocardiogram (ECG) for this assessment, but this interrupts patient care. Our hospital recently introduced bedside monitors in the intensive care unit (ICU) with continuous QT/QTc software. However, only four of the seven available ECG leads are used.

PURPOSE: Evaluate the agreement between computerized QT/QTc measurements from the bedside monitor (four leads) and a time-matched standard 12-lead ECG.

DESIGN: Prospective observational study in three adult ICUs.

METHODS: QT/QTc measurements were obtained from a convenience sample, and the two ECG types were ≤ 30 min apart. Agreement was evaluated using Bland-Altman analysis.

RESULTS: A total of 120 patients were evaluated for inclusion, and 60 (50%) had a 12-lead ECG for comparison. The mean bias difference for QT measurements was not statistically different (β = -2.47, 95% CI = 5.50 to -11.05; p = 0.44; limits of agreement (LOA) = -64.37 to 59.44). Similar non-statistical differences were observed for QTc (β = -3.20, 95% CI = 5.50 to -11.05; p = 0.44; LOA = -67.43 to 61.03).

CONCLUSION: There was good agreement for both QT and QTc measurements between the two methods. These pilot data are promising and suggest QT/QTc measurements from bedside monitors (four leads) may be an acceptable alternative to obtaining additional standard 12-lead ECGs. Given that half of the ICU patients screened did not have a 12-lead ECG recorded, bedside monitor QT/QTc’s could identify at-risk patients. However, an evaluation in a larger sample and non-ICU patients is warranted.

PMID:39645597 | DOI:10.1111/anec.70031

Iran Biomed J. 2024 Dec 1;28(7):3.

ABSTRACT

INTRODUCTION: As climate change continues to reshape our environment, accurately forecasting air quality becomes essential for developing effective public health and environmental strategies. This study investigates changes in particulate matter (PM10) concentrations under the Shared Socioeconomic Pathways of the Climate Model Intercomparison Project Phase 6 (CMIP6).

METHODS AND MATERIALS: Historical climatic data (1998-2014) were collected to establish baseline conditions, and vital climatic variables-maximum and minimum temperatures, precipitation, and radiation-were gathered between 2013 and 2022 from the Iran Meteorological Organization. The Long Ashton Research Station Weather Generator (LARS-WG 6.0) software was used to perform statistical downscaling, generating high-resolution time series datasets from the historical climatic data. The MIROC6 atmospheric circulation models simulated future climate scenarios using three Shared Socioeconomic Pathways (SSPs) from the sixth IPCC Assessment Report (AR6): optimistic (SSP1-2.6), intermediate (SSP2-4.5), and pessimistic (SSP3-7.0). Monthly PM10 concentrations were obtained from MODIS satellite images. An Artificial Neural Network Nonlinear Autoregressive with Exogenous Input (ANN-NARX) model was developed using the collected climatic variables as predictors, and this model was used to estimate PM10 concentrations for the period 2023-2042 under each SSP scenario.

RESULTS: In various SSP scenarios, PM10 levels were assessed between 2023 and 2042. An increase in PM10 was observed across all scenarios, particularly during the hotter months of summer and spring over the next 20 years. The SSP2-4.5 scenario showed minimal change, maintaining levels close to historical data. In contrast, SSP3-7.0 exhibited significant increases in PM10, especially during the warmer months of summer and spring. Sensitivity analysis identified radiation and maximum temperature as critical factors influencing PM10 predictions, with sensitivity plots showing a notable increase in MSE when these factors were removed. The ANN-NARX model demonstrated satisfactory performance across the training, validation, and testing sets, with RMSE values ranging from 0.15 to 0.30, MAE values from 0.10 to 0.35, and MSE values from 0.01 to 0.1, and R values from 0.91 to 0.92.

CONCLUSION AND DISCUSSION: The study concluded that PM10 concentrations in Ahvaz were significantly influenced by radiation and maximum temperature. The anticipated temperature increases under various SSP scenarios suggest a potential decline in future air quality, with expected rises in PM10 levels. These findings underscore the urgent need for effective air quality management and climate adaptation strategies in Ahvaz.

PMID:39645595

Iran Biomed J. 2024 Dec 1;28(7):2.

ABSTRACT

INTRODUCTION: Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorder in women of reproductive age globally. It is linked to a higher prevalence of metabolic syndrome, cardiovascular diseases, and type 2 diabetes. Time-restricted eating is a type of intermittent fasting. That is a promising strategy for weight loss and glucose and lipid metabolism improvements. However, the exact time for the restriction of food intake is controversial. It is unclear to the beginning (early TRE, eTRE) or the middle of the day (middle TRE, mTRE). So, this study aims to determine whether eTRE or mTRE is a better dietary approach to improving the metabolic disorder of polycystic ovary syndrome.

METHODS AND MATERIALS: In this clinical randomized trial, we conducted a 6-week study to compare the effects of e-TRE (8:00-18:00/n=25) and m-TRE (11:00-21:00/n=25) on anthropometric indices, insulin sensitivity, and other glycemic and lipid profiles. A total of fifty overweight or obese women, aged between 18-40 and diagnosed with PCOS by modified Rotterdam criteria, were randomly assigned to one of two groups. We evaluated changes in body weight, waist circumference (WC), body mass index (BMI), fasting blood sugar (FBS), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR), total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL). We used independent t-test and paired t-test (and their non-parametric equivalent) to analyze the differences.

RESULTS: The analyses showed that significant changes in body weight, WC, BMI, FBS, and HOMA-IR were found after 6 weeks in both intervention groups (p = 0.0001). In addition, e-TRE significantly improved fasting insulin, TC, and LDL (p = 0.0001); however, no significant relation was observed in the m-TRE group (p = 0.05). Changes in TG and HDL were not statistically significant (p = 0.05). A comparison of the two groups revealed a substantial difference in weight, BMI, FBS, TC, LDL, fasting insulin, and HOMA-IR (p = 0.05).

CONCLUSION AND DISCUSSION: Overall, our findings suggest that e-TRE is more effective than m-TRE for losing weight and reducing insulin resistance in patients with polycystic ovary syndrome. However, results on lipid profile are conflicting, and further randomized control trials are needed.

PMID:39645592

Cancer. 2024 Dec 8. doi: 10.1002/cncr.35679. Online ahead of print.

ABSTRACT

BACKGROUND: Nivolumab obtained approval in advanced melanoma (AM) with weight-adjusted dose (WAD) administration (3 mg/kg/2 weeks). In 2018, the dosage regimen was changed to flat dose (FD) administration (240 mg/2 weeks or 480 mg/4 weeks) based on a modeling study, without clinical data.

METHODS: AM patients have been prospectively included in the French national multicenter MelBase database since 2013. First-line patients treated with nivolumab monotherapy were included in the WAD or FD groups of this study. The primary end point was the incidence of grade ≥3 immune-related adverse events (irAEs). Secondary end points were incidence of any grade irAEs, and overall survival (OS) and progression-free survival (PFS). Inverse probability of treatment weighting was used to balance groups on their baseline characteristics.

RESULTS: Between 2015 and 2022, 348 patients were included: 160 in the WAD and 188 in the FD groups. In the FD group, 45% and 27% of patients weighed <75 kg and >85 kg, respectively. Grade ≥3 and any grade irAEs rates were 13.1% versus 11.7% (p = .8) and 63.1% versus 67.0% (p = .5) in the WAD and FD groups, respectively. After weighting, median PFS was 3.1 and 3.7 months (hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.65-1.07), and median OS was 24.8 and 37.0 months (HR, 0.74; 95% CI, 0.54-1.01) in the WAD and FD groups, respectively.

CONCLUSIONS: There was no difference in the incidence of severe irAEs and in median PFS between AM patients treated by WAD or FD nivolumab. The median OS between patient groups did not reach statistical significance.

PMID:39645590 | DOI:10.1002/cncr.35679

Med Sci Monit. 2024 Dec 8;30:e946624. doi: 10.12659/MSM.946624.

ABSTRACT

BACKGROUND This study used an edentulous mandibular resin model with 6 parallel osteotomy sites and aimed to compare the accuracy (trueness and precision) of 10 digital impressions using 3 intraoral scanners, the 3Shape TRIOS 5, Medit i700, and Primescan, using Medit Link v3.3.2 software. MATERIAL AND METHODS A model simulating a patient’s lower jaw was surgically prepared at 6 parallel sites (implant osteotomy), allowing placement of 6 implant analogues. Matrix-Direct transfer abutments were attached to the analogs, and a reference scan was obtained using a CeramilMap 600 extraoral scanner. Three intraoral scanners (3Shape TRIOS 5, Medit i700, and Primescan) made 10 digital impressions of each model. The data obtained were superimposed and compared using software (Medit Link 3.3.2) to evaluate accuracy. Mean values were statistically analyzed using one-way ANOVA and post hoc Tukey test. Differences were considered significant at a P value of less than 0.05. RESULTS The TRIOS 5 intraoral scanner displayed the lowest deviation for precision (37.8±4.53 μm) and trueness (54.9±11 μm), followed by Medit i700 (precision 40.6±4.17 μm, trueness 60.5±10.9 μm), whereas the highest deviation (precision: 49.1±8.31 μm, trueness: 72.3±10.4 μm) was reported when Primescan intraoral scanner was used for recording impressions of full arch implants. When the 3 intraoral scanners were compared, a statistically significant difference was observed in terms of precision (P<0.005) and trueness (P<0.005). CONCLUSIONS TRIOS 5 intraoral scanner displayed the lowest deviation values for precision and trueness (more accurate), followed by Medit i700 and Primescan intraoral scanners. However, deviation values of all scanners were within clinically acceptable limits.

PMID:39645575 | DOI:10.12659/MSM.946624

BMC Pediatr. 2024 Dec 7;24(1):803. doi: 10.1186/s12887-024-05306-9.

ABSTRACT

OBJECTIVE: Tic disorders (TD) often present with associated neuropsychiatric comorbidities. This study aims to examine the clinical manifestations of TD in pediatric patients and explore the spectrum and features of neuropsychiatric comorbidities among Chinese children diagnosed with TD.

METHODS: A retrospective analysis was conducted on pediatric TD cases newly diagnosed at our institution, using the Mini International Neuropsychiatric Interview for Children and Adolescents 5.0 to screen for comorbidities. Furthermore, a statistical analysis of clinical features was undertaken.

RESULTS: The study enrolled 182 patients, comprising 140 males and 42 females. The diagnoses were distributed as follows: 65 cases of provisional TD, 29 cases of chronic TD, and 88 cases of Tourette syndrome. 94 (51.65%) patients presented with at least a single neuropsychiatric comorbid, while 40 (21.98%) patients exhibited two or more such comorbidities. TD is most frequently comorbid with attention-deficit hyperactivity disorder (33.52%, 61/182), oppositional defiant disorder (11.00%, 20/182) and current/previous manic/hypomanic episode (7.69%, 14/182). Children with comorbidities, compared to those without, experienced delayed diagnosis (P = 0.039), were more prone to developing vocal tics (simple vocal tics P = 0.030, complex vocal tics P < 0.001), lacked sibling companionship (P = 0.030), and exhibited more severe tics (P = 0.008). The prevalence of comorbidities was notably higher in children from single-parent households (93.3%) compared to those in two-parent families (P = 0.006). Individuals with multiple comorbidities had delayed diagnosis (P = 0.013), and notably experienced more triggering psychological factors such as pressure, anxiety, and anger. Sex, parents’ educational backgrounds and severity of tics significantly related to specific comorbidity occurrence.

CONCLUSION: We identified several factors associated with comorbidities in children with TD, which aiding doctors in recognizing the comorbidities that require attention. Simultaneously, these factors help guide family members in providing targeted education that supports the physical and mental development of affected children.

PMID:39645567 | DOI:10.1186/s12887-024-05306-9

BMC Pediatr. 2024 Dec 7;24(1):804. doi: 10.1186/s12887-024-05295-9.

ABSTRACT

BACKGROUND: In July 2022, Uganda’s Ministry of Health extended the 2021 WHO guidelines that recommended 3-6 monthly dispensing of antiretroviral therapy (ART) to include all children and adolescents living with HIV (CALHIV). Treatment outcomes following this recommendation have not yet been documented. We compared viral load (VL) suppression and retention in HIV care rates among CALHIV receiving 1, 2-5, and > = 6 monthly ART dispensation in Uganda.

METHODS: A cross-sectional study of electronic medical records in 118 health facilities was conducted. Data for CALHIV 10-19 years captured at their most recent five clinic visits as of 15th May 2023 were analysed. Most recent two VL < 1000 copies/ml were used as measures for VL suppression and sustained VL suppression. A client was considered retained in care if they visited the clinic within 28 days from their expected return visit date. We used margins plots and a modified poisson model adjusting for facility level clustering to assess VL suppression and retention across multi-month ART categories.

RESULTS: A total of 2864 CALHIV, 1609 (56.2%) being females and with a median age of 12 years (inter quartile range, iqr = 7) were included. Overall suppression and retention rates were 80.4% (2133/2654) and 87.8% (2514/2864) respectively. A significant number had been dispensed ART for ≥ 2 months (50%, 2-5 months and 43.5%, ≥ 6 months). Probability of having a suppressed VL was higher among CALHIV that had received ≥ 6 months and 2-5 months of ART compared to those of 1 month i.e., 83% vs 79% vs 41% respectively. Probability of being retained in care didn’t differ across multi-month ART categories. CALHIV who received ART for 2-5 months and ≥ 6 months compared to 1 month were more likely to have a suppressed VL; (adj.PR = 1.98; 95%CI:1.41, 2.80) and (adj.PR = 2.21; 95% CI:1.59, 3.05) respectively. CALHIV with a Tuberculosis diagnosis history were less likely to have a suppressed VL (adj.PR = 0.73; 95%CI:0.65,0.81), however this was not statistically significantly different between multi-month categories.

CONCLUSION: CALHIV receiving multi-month ART including 6 months dispensation had better VL suppression rates. Retention rates however didn’t differ by multi-month dispensing categories as observed among adults in the interval trial. We recommend multi-month ART dispensation including more than 6 months among CALHIV irrespective of their age, clinical stage, and history of prior co-morbidities.

PMID:39645566 | DOI:10.1186/s12887-024-05295-9

Prostate Cancer Prostatic Dis. 2024 Dec 7. doi: 10.1038/s41391-024-00924-x. Online ahead of print.

ABSTRACT

BACKGROUND: Without head-to-head trials between talazoparib+enzalutamide (TALA + ENZA), olaparib+abiraterone acetate (OLAP + AAP), and niraparib plus AAP (NIRA + AAP) the ability to evaluate their relative efficacy as first-line (1 L) treatment in metastatic castration-resistant prostate cancer (mCRPC) is limited. The objective of this study was to assess the relative efficacy between TALA + ENZA (TALAPRO-2) versus OLAP + AAP (PROpel) and NIRA + AAP (MAGNITUDE) in 1 L mCRPC via a matching-adjusted indirect treatment comparison (MAIC).

METHODS: Patient-level data from TALAPRO-2 and published data from PROpel and MAGNITUDE were used. TALAPRO-2 data were reweighted to satisfy the eligibility criteria for PROpel and MAGNITUDE. Talazoparib (0.5 mg/day) plus enzalutamide (160 mg/day) was compared to olaparib (300 mg twice daily) plus abiraterone acetate (1000 mg/day) and niraparib (200 mg/day) plus abiraterone acetate (1000 mg/day). Hazard ratios (HRs) were calculated for radiographic progression-free survival (rPFS) and overall survival (OS), and odds ratios (ORs) for prostate-specific antigen (PSA) response and objective response rate (ORR). Additional efficacy outcomes were assessed.

RESULTS: In all-comers, TALA + ENZA was statistically superior to OLAP + AAP for rPFS (HR: 0.727; 95% confidence interval [CI]: 0.565, 0.935) and PSA response (OR: 1.663; 1.101, 2.510), and numerically favored for OS (HR: 0.847; 0.667, 1.076) and ORR (OR: 1.109; 0.646, 1.903). In patients with homologous recombination repair mutations (HRRm), relative to NIRA + AAP, TALA + ENZA was statistically superior for rPFS (HR: 0.460; 0.280, 0.754), and numerically favored for OS (HR: 0.601; 0.347, 1.041) and ORR (OR: 1.524; 0.579, 4.016).

CONCLUSIONS: Results suggest that TALA + ENZA may provide improvements in clinical outcomes relative to OLAP + AAP and NIRA + AAP in 1 L mCRPC; however, inherent limitations associated with the complexity of the analyses must be considered.

PMID:39645562 | DOI:10.1038/s41391-024-00924-x