Category: Statistics

Drug Saf. 2023 Aug 9. doi: 10.1007/s40264-023-01332-1. Online ahead of print.

ABSTRACT

INTRODUCTION: In February 2021, New Zealand began its largest ever immunisation programme with the BNT162b2 mRNA coronavirus disease 2019 (COVID-19) vaccine.

OBJECTIVE: We aimed to understand the association between 12 adverse events of special interest (AESIs) and a primary dose of BNT162b2 in the New Zealand population aged ≥5 years from 19 February 2021 through 10 February 2022.

METHODS: Using national electronic health records, the observed rates of AESIs within a risk period (1-21 days) following vaccination were compared with the expected rates based on background data (2014-2019). Standardised incidence ratios (SIRs) were estimated for each AESI with 95% confidence intervals (CIs) using age group-specific background rates. The risk difference was calculated to estimate the excess or reduced number of events per 100,000 persons vaccinated in the risk period.

RESULTS: As of 10 February 2022, 4,277,163 first doses and 4,114,364 second doses of BNT162b2 had been administered to the eligible New Zealand population aged ≥5 years. The SIRs for 11 of the 12 selected AESIs were not statistically significantly increased post vaccination. The SIR (95% CI) for myo/pericarditis following the first dose was 2.3 (1.8-2.7), with a risk difference (95% CI) of 1.3 (0.9-1.8), per 100,000 persons vaccinated, and 4.0 (3.4-4.6), with a risk difference of 3.1 (2.5-3.7), per 100,000 persons vaccinated following the second dose. The highest SIR was 25.6 (15.5-37.5) in the 5-19 years age group, following the second dose of the vaccine, with an estimated five additional myo/pericarditis cases per 100,000 persons vaccinated. A statistically significant increased SIR of single organ cutaneous vasculitis (SOCV) was also observed following the first dose of BNT162b2 in the 20-39 years age group only.

CONCLUSIONS: A statistically significant association between BNT162b2 vaccination and myo/pericarditis was observed. This association has been confirmed internationally. BNT162b2 was not found to be associated with the other AESIs investigated, except for SOCV following the first dose of BNT162b2 in the 20-39 years age group only, providing reassurances around the safety of the vaccine.

PMID:37556109 | DOI:10.1007/s40264-023-01332-1

Int Urol Nephrol. 2023 Aug 9. doi: 10.1007/s11255-023-03733-8. Online ahead of print.

ABSTRACT

INTRODUCTION: Our study aimed to evaluate the performance of Quick Sepsis-related Organ Failure Assessment (qSOFA), Modified Early Warning Score (MEWS), National Early Warning Score (NEWS), Systemic Inflammatory Response Syndrome (SIRS), and Global Research in the Emphysematous Pyelonephritis group (GREMP) in predicting the need of admission in intensive care units (ICU) for emphysematous pyelonephritis (EPN) patient.

PATIENTS AND METHODS: In this retrospective study, we reviewed 70 patients admitted to our department from January 2008 to October 2022. Data on clinical presentation and EPN management were noted. The five scoring systems were calculated by one investigator. Univariate and multivariate analyses were used to assess predictive factors of severe sepsis and mortality. Statistical analysis was made using SPSS version 22.

RESULTS: Mean age was 61.83 years with 65.7% diabetes. As per Huang and Tseng classification, 41 patients had class I EPN, 7 had class II EPN, 8 had class IIIa, 6 class IIIB EPN, and 8 had class IV EPN. Seventeen patients (24.28%) were admitted to ICU with an 18.57 mortality rate. Univariate analysis showed that ICU admission was significantly associated with higher respiration rate and heart rate, lower systolic blood pressure, confusion, CRP, lactate and creatinine serum (p = 0.0001, p = 0.0001, p = 0.001, p = 0.007, p = 0.004, p = 0.001, p = 0.001, respectively). All five scores and Huang and Tseng classification were significantly predictive of admission to ICU. All five scores showed good results under the area curves to predict ICU entry with 0.915, 0.895, 0.968, 0.887, and 0.846 for qSOFA, MEWS score, NEWS score, SIRS, and GREMP score, respectively.

CONCLUSION: NEWS score seemed to be the best performing physiologic score among the five scoring systems studied and may help with biological and radiological findings to quickly identify EPN patients that need intensive care unit.

PMID:37556105 | DOI:10.1007/s11255-023-03733-8

MAGMA. 2023 Aug 9. doi: 10.1007/s10334-023-01112-z. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the reproducibility of radiomics features derived via different pre-processing settings from paired T2-weighted imaging (T2WI) prostate lesions acquired within a short interval, to select the setting that yields the highest number of reproducible features, and to evaluate the impact of disease characteristics (i.e., clinical variables) on features reproducibility.

MATERIALS AND METHODS: A dataset of 50 patients imaged using T2WI at 2 consecutive examinations was used. The dataset was pre-processed using 48 different settings. A total of 107 radiomics features were extracted from manual delineations of 74 lesions. The inter-scan reproducibility of each feature was measured using the intra-class correlation coefficient (ICC), with ICC values > 0.75 considered good. Statistical differences were assessed using Mann-Whitney U and Kruskal-Wallis tests.

RESULTS: The pre-processing parameters strongly influenced the reproducibility of radiomics features of T2WI prostate lesions. The setting that yielded the highest number of features (25 features) with high reproducibility was the relative discretization with a fixed bin number of 64, no signal intensity normalization, and outlier filtering by excluding outliers. Disease characteristics did not significantly impact the reproducibility of radiomics features.

CONCLUSION: The reproducibility of T2WI radiomics features was significantly influenced by pre-processing parameters, but not by disease characteristics. The selected pre-processing setting yielded 25 reproducible features.

PMID:37556085 | DOI:10.1007/s10334-023-01112-z

Pain Ther. 2023 Aug 9. doi: 10.1007/s40122-023-00543-9. Online ahead of print.

ABSTRACT

INTRODUCTION: The evolution of pre- versus postoperative risk factors remains unknown in the development of persistent postoperative pain and opioid use. We identified preoperative versus comprehensive perioperative models of delayed pain and opioid cessation after total joint arthroplasty including time-varying postoperative changes in emotional distress. We hypothesized that time-varying longitudinal measures of postoperative psychological distress, as well as pre- and postoperative use of opioids would be the most significant risk factors for both outcomes.

METHODS: A prospective cohort of 188 patients undergoing total hip or knee arthroplasty at Stanford Hospital completed baseline pain, opioid use, and emotional distress assessments. After surgery, a modified Brief Pain Inventory was assessed daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 1 year. Emotional distress and pain catastrophizing were assessed weekly to 6 months, then monthly thereafter. Stepwise multivariate time-varying Cox regression modeled preoperative variables alone, followed by all perioperative variables (before and after surgery) with time to postoperative opioid and pain cessation.

RESULTS: The median time to opioid and pain cessation was 54 and 152 days, respectively. Preoperative total daily oral morphine equivalent use (hazard ratio-HR 0.97; 95% confidence interval-CI 0.96-0.98) was significantly associated with delayed postoperative opioid cessation in the perioperative model. In contrast, time-varying postoperative factors: elevated PROMIS (Patient-Reported Outcomes Measurement Information System) depression scores (HR 0.92; 95% CI 0.87-0.98), and higher Pain Catastrophizing Scale scores (HR 0.85; 95% CI 0.75-0.97) were independently associated with delayed postoperative pain resolution in the perioperative model.

CONCLUSIONS: These findings highlight preoperative opioid use as a key determinant of delayed postoperative opioid cessation, while postoperative elevations in depressive symptoms and pain catastrophizing are associated with persistent pain after total joint arthroplasty providing the rationale for continued risk stratification before and after surgery to identify patients at highest risk for these distinct outcomes. Interventions targeting these perioperative risk factors may prevent prolonged postoperative pain and opioid use.

PMID:37556071 | DOI:10.1007/s40122-023-00543-9

Environ Sci Pollut Res Int. 2023 Aug 9. doi: 10.1007/s11356-023-29051-1. Online ahead of print.

ABSTRACT

The research objective of this research paper is to examine the relationships between organizational commitment to emission trading schemes, artificial intelligence, and climate entrepreneurship, as well as their impact on sustainable performance, i.e., environmental and organizational performance in organizations. This study aims to identify the key drivers and barriers to the adoption of these factors and to understand how they influence environmental and organizational performance. The study utilizes a cause-and-effect design on the sampled size of 387 subjects and employs the Smart PLS version 4.0 statistical tool to estimate the interactions between all constructs in the structural equation modeling. The research questions aim to explore the key drivers and barriers to the adoption of these factors in organization and their impact on sustainable performance, i.e., environmental and organizational performance. The study hypothesizes that organizational commitment to emission trading schemes, AI, and climate entrepreneurship has a positive impact on sustainable performances such as environmental and organizational performance. The findings suggest that attitudes toward AI and emission trading schemes have a direct impact on climate entrepreneurship, environmental performance, and organizational performance. By considering these factors together, the study seeks to uncover the synergistic effects and potential interactions between them and sheds light on their combined influence on environmental and organizational performance. Organizations can enhance environmental and organizational performance by prioritizing their attitudes toward emission trading schemes, AI, and climate entrepreneurship through resource allocation, technology investment, and fostering a climate entrepreneurship mindset. The research concludes that businesses that demonstrate high organizational commitment, positive attitude toward the ETS, and a focus on climate entrepreneurship experiences improved environmental and organizational performance.

PMID:37556056 | DOI:10.1007/s11356-023-29051-1

J Nephrol. 2023 Aug 9. doi: 10.1007/s40620-023-01696-8. Online ahead of print.

ABSTRACT

BACKGROUND: Parenthood data has been collected by the Australia and New Zealand Dialysis and Transplant Registry (ANZDATA) since its inception in 1968, with a specific parenthood survey since 2001 of core maternal and fetal outcomes, which was further expanded in 2017 to collect additional obstetric and clinical data. We evaluated the parenthood dataset completeness over the evolution of the surveys.

METHODS: Descriptive statistics were used to quantify the completeness of data reported for male and female patients receiving KRT between 1963 and 2021 and compare parenthood surveys over time.

RESULTS: Core data items consistently had more than 85% completeness rates for all survey iterations. Most data items introduced in 2018 had less than 85% completeness. Of these, drug therapy during pregnancy, common medical complications, and labour and delivery data items had the highest completeness (70-85%), whereas dialysis-related items had a wide range of completeness, ranging from 44 to 80%.

CONCLUSION: Our findings underpin the robustness of the ANZDATA parenthood dataset but also highlight that more detailed clinical data can be difficult to capture, despite enabling better understanding of drivers of outcomes and risk stratification in this high-risk cohort. To overcome current limitations, strategies must be implemented to augment data completeness.

PMID:37556051 | DOI:10.1007/s40620-023-01696-8

J Cardiovasc Transl Res. 2023 Aug 9. doi: 10.1007/s12265-023-10422-5. Online ahead of print.

ABSTRACT

Coronary artery disease (CAD) risk and plaque scores are often subjective and biased, particularly in mid-age asymptomatic women, whose CAD risk assessment has been historically underestimated. In this study, a new automatic ascending aorta time-to-peak-distention (TPD) analysis was developed for fast screening and as an independent surrogate for subclinical atherosclerosis in asymptomatic women. CCTA was obtained in 50 asymptomatic adults. Plaque burden segment involvement score (SIS) and automatic TPD were obtained from all subjects. Logistic regression analyses were performed to investigate the association between CAD risk scores and TPD with severe coronary plaque burden (SIS>5). TPD, individually, was found to be a significant predictor of SIS>5. Additionally, sex was a significant effect modifier of TPD, with a stronger statistically significant association with women. Four-dimensional aortic time-to-peak distention could supplement conventional CCTA analysis and offer a quick objective screening tool for plaque burden severity and CAD risk stratification, especially in women.

PMID:37556037 | DOI:10.1007/s12265-023-10422-5

J Immigr Minor Health. 2023 Aug 9. doi: 10.1007/s10903-023-01529-7. Online ahead of print.

ABSTRACT

Mammography screening rates remain low among Asian American women (AAW). The aims of our study were to: (a) assess breast cancer knowledge and mammography screening behaviors, and (b) identify the factors related to the transtheoretical model (TTM) stages of change in relation to mammography utilization among AAW aged 40 and older. Using a cross-sectional design, a convenience sample of 714 AAW completed a structured questionnaire in 2021. Participants demonstrated a moderate level of knowledge regarding breast cancer and mammography. Only 34.2% of the participants reported obtaining regular mammograms. The ordinal logistic regression indicated that age, birthplace, health perception, breast biopsy history, breast cancer knowledge, self-efficacy, and perceived barriers were correlated with TTM stages of change. Our results highlight the need for implementing effective interventions aimed at increasing knowledge and screening rates for breast cancer among AAW. Additional TTM studies with AAW are needed to determine the relationships among TTM constructs and develop theory-based programs to improve adherence to screening guidelines. Future research using a mixed-method design may provide opportunities to explore complex phenomena associated with breast cancer screening behaviors. Finally, further assessments of the Breast Cancer Knowledge Scale’s psychometric properties are necessary to improve this instrument.

PMID:37556031 | DOI:10.1007/s10903-023-01529-7

Acta Neurochir (Wien). 2023 Aug 9. doi: 10.1007/s00701-023-05726-z. Online ahead of print.

ABSTRACT

BACKGROUND: Although there is an increasing body of evidence showing gender differences in various medical domains as well as presentation and biology of pituitary adenoma (PA), gender differences regarding outcome of patients who underwent transsphenoidal resection of PA are poorly understood. The aim of this study was to identify gender differences in PA surgery.

METHODS: The PubMed/MEDLINE database was searched up to April 2023 to identify eligible articles. Quality appraisal and extraction were performed in duplicate.

RESULTS: A total of 40 studies including 4989 patients were included in this systematic review and meta-analysis. Our analysis showed odds ratio of postoperative biochemical remission in males vs. females of 0.83 (95% CI 0.59-1.15, P = 0.26), odds ratio of gross total resection in male vs. female patients of 0.68 (95% CI 0.34-1.39, P = 0.30), odds ratio of postoperative diabetes insipidus in male vs. female patients of 0.40 (95% CI 0.26-0.64, P < 0.0001), and a mean difference of preoperative level of prolactin in male vs. female patients of 11.62 (95% CI – 119.04-142.27, P = 0.86).

CONCLUSIONS: There was a significantly higher rate of postoperative DI in female patients after endoscopic or microscopic transsphenoidal PA surgery, and although there was some data in isolated studies suggesting influence of gender on postoperative biochemical remission, rate of GTR, and preoperative prolactin levels, these findings could not be confirmed in this meta-analysis and demonstrated no statistically significant effect. Further research is needed and future studies concerning PA surgery should report their data by gender or sexual hormones and ideally further assess their impact on PA surgery.

PMID:37555999 | DOI:10.1007/s00701-023-05726-z

Eur J Trauma Emerg Surg. 2023 Aug 9. doi: 10.1007/s00068-023-02328-3. Online ahead of print.

ABSTRACT

INTRODUCTION: Colorectal injuries following traumas are significant causes of morbidity and mortality. This study aimed to evaluate the predictive effect of trauma scoring systems on mortality and morbidity in patients with post-traumatic colon injury.

METHODS: The records of 145 patients with colon trauma treated at Seyhan State Hospital between January 1, 2010, and January 1, 2020, were retrospectively analyzed. Injury Seriousness Score (ISS), Revised Trauma Score (RTS), Trauma Injury Severity Score (TRISS), and Colon Injury Score (CIS) scores were calculated for all patients. The predictive effects of scoring systems on primary outcomes of surgical treatment, complication rates, mortality, and anastomotic leaks were evaluated.

RESULTS: The mean age of the patients was 36.1 (SD ± 16.6), and the female/male ratio was 37/108. Anastomotic leakage occurred in 12 (8.2%) patients, and complications were observed in 57 (39.3%) patients. Seven (4.7%) patients died. A statistically significant relationship was observed between the increase in CIS and anastomotic leakage, morbidity, and mortality. Increases in ISS and decreases in RTS and TRISS were associated with increased morbidity and mortality, but these relationships were not statistically significant.

CONCLUSION: A significant relationship was observed between the increase in CIS and anastomotic leakage, morbidity, and mortality. The study suggests the need for a specific scoring system for evaluating the prognostic status in colon traumas, as ISS, RTS, and TRISS scores were not found to be significantly predictive of outcomes in this patient population.

PMID:37555993 | DOI:10.1007/s00068-023-02328-3