Tag: statistics

Circ J. 2023 Feb 21. doi: 10.1253/circj.CJ-22-0682. Online ahead of print.

ABSTRACT

BACKGROUND: Fluoroquinolone use can be associated with an increased risk of aortic aneurysm (AA) or aortic dissection (AD). The US Food and Drug Administration recently warned against fluoroquinolone use for high-risk patients, such as those with Marfan syndrome. However, the association between fluoroquinolone use and AA/AD risk was unknown in these high-risk patients and therefore it was studied in this work.Methods and Results: Data were collected from a national database between 2000 and 2017 for 550 patients with AA/AD and any congenital aortic disease (mean age 41.5 years; 415 with Marfan syndrome). A case cross-over study was conducted to compare the risk of aortic events (AA/AD) associated with fluoroquinolone and amoxicillin use between the hazard period (from -60 days to -1 day) and a randomly selected reference period (-180 to -121 days; -240 to -181 days; and -300 to -241 days). Compared to the reference period without fluoroquinolone use, fluoroquinolone use during the hazard period was not associated with a greater risk of AA/AD (1.09% vs. 1.09%; odds ratio [OR] 1.000; 95% confidence interval [CI] 0.32-3.10), AA (OR 0.67; 95% CI 0.11-3.99), or AD (OR 1.33; 95% CI 0.30-5.96) in patients with congenital aortic disease or Marfan syndrome. This lack of association was maintained in subgroup analysis, including Marfan syndrome or not, age (≤50 vs. >50 years) and sex.

CONCLUSIONS: Fluoroquinolone use was not associated with an increased risk of AA/AD in patients with congenital aortic disease, including Marfan syndrome. More evidence is required for a fluoroquinolone pharmacovigilance plan in these patients.

PMID:36823078 | DOI:10.1253/circj.CJ-22-0682

Psychol Rep. 2023 Feb 23:332941231159611. doi: 10.1177/00332941231159611. Online ahead of print.

ABSTRACT

The COVID-19 pandemic and its link to the emergence of everyday sadism is a matter of public concern worldwide. However, previous studies are nearly silent regarding the causal relationship between the two variables. We address this gap by theorizing that exposure to information about coronavirus can increase sadistic behavior by inducing state boredom. We conducted three complementary controlled experiments, which comprised multiple participants populations (N = 784, student and community samples) and measurement techniques of sadism, to test our theoretical perspective. Based on self-report measures, Study 1 found that Chinese university students who were exposed to a reminder of COVID-19 exhibited a higher level of everyday sadism than participants in the control condition. Study 2 replicated this finding in a more generalized population. Additionally, results revealed that state boredom mediated this effect. Moving beyond subjective self-report data in Studies 1 and 2, Study 3 assessed a different behavioral operationalization of sadistic tendencies, namely, shredding worms. As expected, priming COVID-19 salience has an immediate, statistically significant influence on sadistic behavior in impactful real-world contexts. Overall, these findings suggest that the COVID-19 pandemic not only has grave effects on economy and society, but has implications for the malevolent side of human nature.

PMID:36823028 | DOI:10.1177/00332941231159611

Clin Genitourin Cancer. 2023 Jan 20:S1558-7673(23)00025-3. doi: 10.1016/j.clgc.2023.01.005. Online ahead of print.

ABSTRACT

Pembrolizumab, a PD-1 ICI is approved for the adjuvant treatment of postnephrectomy patients with clear cell RCC in some countries worldwide. However, recent negative data from randomized clinical trials (RCT) with another ICIs makes the benefit of this treatment uncertain. A systematic review and study-level meta-analysis was performed to evaluate the benefit of disease-free survival (DFS) with adjuvant ICI treatment for patients with localized and/or metastatic resected RCC. Using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement, a systematic search was performed in PUBMED/MEDLINE, Scopus and EMBASE up to September 15, 2022. The statistical analysis was performed by ProMeta 3 software in intention-to-treat (ITT) population and in predetermined subgroups. Four RCT totalizing 3407 patients were included in this analysis. Systemic immunotherapy was pembrolizumab, atezolizumab, nivolumab, and ipilimumab plus nivolumab in 496, 390, 404, and 405 patients, respectively. In the ITT population there was a nonstatistically significant DFS benefit with adjuvant ICI (HR: 0.85, 95% CI: 0.69-1.04). Regarding the subgroups, there was a DFS benefit for PD-L1 positive (HR: 0.72; 95% CI: 0.55-0.94), intermediate-high risk patients (HR: 0.77; 95% CI: 0.63-0.94), and patients with sarcomatoid component (HR: 0.66; 95% CI: 0.43-0.99). This meta-analysis did not demonstrate a statistically significant DFS benefit in overall population, however considering the heterogeneity between the RCTs the use of adjuvant ICI should be individualized.

PMID:36823017 | DOI:10.1016/j.clgc.2023.01.005

J Dairy Sci. 2023 Feb 21:S0022-0302(23)00070-X. doi: 10.3168/jds.2022-22567. Online ahead of print.

ABSTRACT

Four categories of transfer of passive immunity (TPI) were recently proposed in response to the widespread high preweaning morbidity and mortality risks in calves with adequate TPI when a dichotomous classification was used. Hitherto, however, the risks of preweaning morbidity and mortality and future performance among these TPI categories have not been compared. Thus, the objective of this retrospective cohort study was to compare dairy calf morbidity, mortality, growth until weaning, and reproductive efficiency until first calving among the categories of poor (<5.1 g/dL total protein), fair (5.1-5.7 g/dL), good (5.8-6.1 g/dL), and excellent (>6.2 g/dL) TPI. For this, the records from 4,336 dairy calves (2,272 female, 2,064 male) born January 2014 to April 2017 on a commercial dairy farm in Michigan were analyzed. These calves had been randomly selected for weekly serum total protein determination on calves 2 to 7 d old. Data from both sexes were used to evaluate preweaning health and mortality, whereas only the female’s data were used to investigate average daily gain (ADG), reproductive performance, and first-lactation milk yield. For each calf, data regarding disease status, growth, and reproductive parameters were obtained from the farm’s software database. Associations of TPI categories with disease events (diarrhea or pneumonia), reproduction indices (age at first insemination, successful insemination, and calving, and number of inseminations), first-lactation milk yield and ADG at weaning were evaluated by survival analysis and mixed models. Compared with calves with excellent TPI, calves in the inferior TPI categories showed increased risk of diarrhea: poor [hazard ratio (HR) = 1.49; 95% CI: 1.22-1.82], fair (HR = 1.32; 95% CI: 1.16-1.51), good (HR = 1.14; 95% CI: 1.02-1.29). However, the risk of pneumonia differed only between the calves in the poor and excellent TPI groups (HR = 1.39; 95% CI: 1.05-1.84). The preweaning mortality risk was also higher in calves with poor TPI (HR = 4.29; 95% CI: 1.98-9.27) compared with excellent TPI. However, mortality risks were not statistically different between calves with fair or good TPI and those with excellent TPI. Similarly, calves with poor TPI had a 64, 55, and 24% lower risk of reaching first insemination, successful insemination, or first calving, respectively. However, there were no differences in ADG, number of inseminations, or first-lactation 305-d mature equivalent milk production across TPI groups. Our results confirm the positive effects of optimal TPI in calf preweaning health and postweaning reproductive efficiency. The 4 proposed categories of TPI can assist in decreasing the incidence of diseases that occur in the first weeks of life (i.e., diarrhea), but their effect on other diseases or future performance might be more limited. Although conducted in one herd, this study can be used to illustrate the effect of TPI on future calf performance.

PMID:36823003 | DOI:10.3168/jds.2022-22567

Clin Radiol. 2023 Jan 13:S0009-9260(22)00744-9. doi: 10.1016/j.crad.2022.12.002. Online ahead of print.

ABSTRACT

AIM: To compare the accuracy of hand-held ultrasonography (US), mammography (MG), magnetic resonance imaging (MRI), and automated breast volume scanning (ABVS) in defining residual breast cancer tumour size after neoadjuvant therapy (NAT).

MATERIALS AND METHODS: Patients diagnosed breast cancer and who received NAT at the Breast Center, Peking University People’s Hospital, were enrolled prospectively. Imaging was performed after the last cycle of NAT. The residual tumour size, intraclass correlation coefficients (ICCs), and receiver operating characteristic (ROC) to predict pathological complete response (pCR) were analysed.

RESULTS: A total of 156 patients with 159 tumours were analysed. ABVS had a moderate correlation with histopathology residual tumour size (ICC = 0.666), and showed high agreement among triple-positive tumours (ICC = 0.797). With 5 mm as the threshold, the coincidence rate reached 64.7% between ABVS and pathological size, which was significantly higher than that between US, MG, MRI, and pathological size (50%, 45.1%, 41.4%; p=0.009, p=0.001, p<0.001, respectively). For ROC analysis, ABVS demonstrated a higher area under the ROC curve, but with no statistical difference, except for MG (0.855, 0.816, 0.819, and 0.788, respectively; p=0.183 for US, p=0.044 for MG, and p=0.397 for MRI, with ABVS as the reference).

CONCLUSIONS: The longest tumour diameter on ABVS had a moderate correlation with pathological residual invasive tumour size. ABVS was shown to have good ability to predict pCR and would appear to be a potential useful tool for the assessment after NAT for breast cancer.

PMID:36822980 | DOI:10.1016/j.crad.2022.12.002

Eur Urol. 2023 Feb 21:S0302-2838(23)02581-2. doi: 10.1016/j.eururo.2023.02.009. Online ahead of print.

ABSTRACT

BACKGROUND: Although survival rates for newly diagnosed prostate cancer patients are very high, most of them will likely suffer significant treatment-related side effects, depression, or anxiety, affecting their quality of life.

OBJECTIVE: The aim of this study was to examine the effects of a 6-mo online home-based physical, mental, and social support intervention, the Prostate Cancer Patient Empowerment Program (PC-PEP), on preventing psychological distress among men undergoing curative prostate cancer treatment.

DESIGN, SETTING, AND PARTICIPANTS: In a crossover randomized clinical trial of 128 men aged 50-82 yr scheduled for curative prostate cancer surgery or radiotherapy (± hormone treatment), 66 received the 6-mo PC-PEP intervention and 62 were randomized to a waitlist-control arm and received the standard of care for 6 mo, and then PC-PEP to the end of the year. The PC-PEP intervention consisted of daily e-mails with video instructions providing education, patient activation, and empowerment on healthy living including physical and mental health, dietary recommendations, social support, physical and pelvic floor fitness, stress reduction using a biofeedback device, social connection and intimacy, and social support.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was nonspecific psychological distress (clinical cutoff ≥20) measured at baseline, and at 6 and 12 mo using the Kessler Psychological Distress Scale (K10).

RESULTS AND LIMITATIONS: At 6 mo, patients in the waitlist-control group had 3.59 (95% confidence interval: 1.12-11.51) times higher odds for nonspecific psychological distress and need for psychological treatment than men who received the PC-PEP intervention. At 12 mo, the wait-list control group that received the intervention at 6 mo had higher psychological distress than the early group.

CONCLUSIONS: PC-PEP delivered early following diagnosis significantly prevented the burden of psychological distress in men undergoing curative prostate cancer treatment compared with standard of care, or late (6 mo later) intervention.

PATIENT SUMMARY: In this report, we looked at the effectiveness of a program (Prostate Cancer Patient Empowerment Program: PC-PEP) developed with patients’ engagement on the mental distress of patients awaiting curative treatment for their prostate cancer. The PC-PEP program lasted for 6 mo, and it prescribed, described, and demonstrated daily aerobic and strength training, kegels (pelvic floor training to help with urinary and sexual function), dietary changes that have been shown to be helpful in the prevention of prostate cancer and prostate cancer progression, stress reduction using a biofeedback device, as well as social and emotional support. All patients in the PC-PEP program were invited to a monthly video conference with the leads of the program who appeared in the 6 mo of daily videos prescribing the activities the patients were asked to watch and follow. The leads were a prostate cancer oncologist and a scientist in prostate cancer quality of life research. Half of the patients in this study received PC-PEP daily for the first 6 mo and were re-assessed at the end of the year. The other half received standard of care for 6 month and then received the intervention to the end of the year. The results of the study show that, at 6 mo, this intervention was effective at reducing the mental distress that accompanies a prostate cancer diagnosis and treatment compared with the standard of care. Mental distress was significantly reduced when the intervention was received early, compared with that received late (6 mo after scheduled curative treatment). We conclude that multi-faceted patient education and empowerment programming of this kind that is developed with patient engagement from the start is crucial to the care of patients diagnosed with prostate cancer and should be implemented in the standard of care. While treatment for prostate cancer is highly successful, side effects that accompany most treatments significantly affect the quality of life of patients. Here, we describe PC-PEP, a patient education and activation program that is cost effective, highly enforced by patients, and successful at reducing the impact of prostate cancer active treatment-related side effects on their psychological state. To learn more about this project, please visit www.pcpep.org. The program is now being tested in a phase 4 implementation trial throughout Canada and internationally (New Zealand), and is being expanded and tested for other types of cancer.

PMID:36822969 | DOI:10.1016/j.eururo.2023.02.009

Inorg Chem. 2023 Feb 23. doi: 10.1021/acs.inorgchem.2c04430. Online ahead of print.

ABSTRACT

The two new ternary amalgams K_1-xRb_xHg₁₁ [x = 0.472(7)] and Cs_3-xCa_xHg₂₀ [x = 0.20(3)] represent two different examples of how to create ternary compounds from binaries by statistical atom substitution. K_1-xRb_xHg₁₁ is a Vegard-type mixed crystal of the isostructural binaries KHg₁₁ and RbHg₁₁ [cubic, BaHg₁₁ structure type, space group Pm3̅m, a = 9.69143(3) Å, Rietveld refinement], whereas Cs_3-xCa_xHg₂₀ is a substitution variant of the Rb₃Hg₂₀ structure type [cubic, space group Pm3̅n, a = 10.89553(14) Å, Rietveld refinement] for which a fully substituted isostructural binary Ca phase is unknown. In K_1-xRb_xHg₁₁, the valence electron concentration (VEC) is not changed by the substitution, whereas in Cs_3-xCa_xHg₂₀, the VEC increases with the Ca content. Amalgams of electropositive metals form polar metal bonds and show “bad metal” properties. By thermal analysis, magnetic susceptibility and resistivity measurements, and density functional theory calculations of the electronic structures, we investigate the effect of the structural disorder introduced by creating mixed-atom occupation on the physical properties of the two new polar amalgam systems.

PMID:36821862 | DOI:10.1021/acs.inorgchem.2c04430

J Pediatr Gastroenterol Nutr. 2023 Feb 24:e003749. doi: 10.1097/MPG.0000000000003749. Online ahead of print.

ABSTRACT

OBJECTIVES: Pediatric patients undergoing esophagogastroduodenoscopy (EGD) commonly receive procedural sedation for comfort and to facilitate the procedure. EGD with procedural sedation carries the risk of several airway incidents and/or adverse events (AIAE). Topical pharyngeal anesthetics can blunt the airway reflexes and decrease the incidence of laryngospasm but has not been well studied with EGD under procedural sedation. We aimed to study the effect of adding a topical pharyngeal anesthetic (TPA) to propofol-based sedation on the rate of AIAE.

METHODS: This is a single-center, retrospective, observational cohort study. We compare AIAE rates (coughing, gagging, apnea, airway obstruction and laryngospasm) in children who received TPA as part of their propofol-based procedural sedation for EGD with those who did not receive TPA.

RESULTS: In 2021, 73 patients received TPA as part of the procedural sedation for EGD and 123 did not. The overall rate of AIAE was high with seventy-five (38%) patients experiencing one or more AIAE. Patients who received benzocaine spray experienced more AIAE than the control group [adjusted OR=1.16; 95% CI (1.01-1.34); p=0.037]. Coughing, gagging, apnea with desaturation rates and laryngospasm were similar in both groups [coughing adjusted OR=1.01; 95% CI (0.91-1.13); p=0.814] [gagging adjusted OR=1.01; 95% CI (0.91-1.13); p=0.814] [apnea adjusted OR=0.99; 95% CI (0.95-1.04); p=0.688] [laryngospasm OR=1.01; 95% CI (0.95-1.07); p=0.71]. The rate of airway obstruction requiring jaw thrust was higher in the benzocaine group but did not reach statistical significance [adjusted OR=1.11; 95% CI (0.97-1.26); p=0.133].

CONCLUSION: The use of topical pharyngeal benzocaine in children undergoing EGD with propofol-based sedation is associated with a higher overall AIAE rate. Most of the AIAE were mild incidents and only seven patients experienced true adverse events.

PMID:36821854 | DOI:10.1097/MPG.0000000000003749

Otolaryngol Head Neck Surg. 2023 Feb 23. doi: 10.1002/ohn.307. Online ahead of print.

ABSTRACT

OBJECTIVE: Assessing whether the additional use of narrow-band imaging (NBI) in transoral laser surgery (TOLS) for early laryngeal cancer improves clinical outcomes.

STUDY DESIGN: Randomized controlled trial, performed between September 2015 and November 2022.

SETTING: A tertiary referral hospital in The Netherlands.

METHODS: TOLS was carried out in 113 patients. The procedure was performed with white light imaging (WLI, n = 56) alone, or combined with NBI (n = 57). Patients received frequent follow-up laryngoscopy. Resection margin status, recurrence rate, and recurrence-free survival at 12 months, 18 months, and after study termination (maximum 86 months) were analyzed.

RESULTS: Thirty-one cases in the WLI group had a positive resection margin, versus 16 in the NBI group (p = .002). After 12 months, the recurrence-free survival was 92%: 87% for WLI versus 96% for NBI, p = .07. The recurrence rate was 7/56 (13%) for WLI, versus 2/57 (4%) for NBI, p = .09. After 18 months, the recurrence-free survival was 84% for WLI versus 96% for NBI, p = .02. The recurrence rate was 9/56 (16%) for WLI, versus 2/57 (4%) for NBI, p = .02. After study termination, the recurrence-free survival was 71% for WLI versus 83% for the NBI group (p = .08). The recurrence rate was 16/56 for WLI, versus 10/57 for NBI (p = .16).

CONCLUSION: The additional use of NBI during TOLS significantly decreased the number of positive resection margins. Although not statistically significant at all time points, patients treated with NBI-supported TOLS showed a lower recurrence rate and better recurrence-free survival. Further studies in larger patient groups are needed to confirm these results.

PMID:36821814 | DOI:10.1002/ohn.307

JCO Glob Oncol. 2023 Feb;9:e2200331. doi: 10.1200/GO.22.00331.

ABSTRACT

PURPOSE: The COVID-19 pandemic has affected public health worldwide. The efficacy and safety of COVID-19 vaccines have been evaluated in the general population; however, data on patients with malignancies are limited.

METHODS: This prospective longitudinal observational cohort study was conducted between June and July 2021. Enrolled adult patients with cancer were divided into chemotherapy and nonchemotherapy groups. All participants were immunized with two doses of the ChAdOx1 nCoV-19 or CoronaVac COVID-19 vaccines. The primary outcome was a comparison of the immunogenicity (as assessed by spike protein [anti-S] immunoglobulin G [IgG] antibody titers) of two doses of COVID-19 vaccine in the chemotherapy and nonchemotherapy groups. The secondary outcomes included the anti-S IgG seroconversion rate and vaccine safety in both groups.

RESULTS: Among the 173 enrolled patients with solid cancer, after COVID-19 vaccination, the chemotherapy group had a significantly lower median anti-S IgG titer than the nonchemotherapy group (26 v 237 U/mL, P < .001). A statistically significant difference in anti-S IgG titer was found between groups vaccinated with CoronaVac (7 v 90 U/mL, P < .001), but no difference was found in those vaccinated with ChAdOx1 nCoV-19 (818 v 1061 U/mL, P = .075). The anti-S IgG seroconversion rate was significantly lower in the chemotherapy group than that in the nonchemotherapy group (78.9% v 96.5%, P = .001). No new or serious vaccine-related adverse events were reported.

CONCLUSION: Patients with solid cancer receiving a COVID-19 vaccine while undergoing chemotherapy had lower immunogenicity responses to vaccination than those who were vaccinated while undergoing nonchemotherapy treatment. No statistically significant difference was observed in the COVID-19 vaccine safety profiles between groups.

PMID:36821802 | DOI:10.1200/GO.22.00331