Tag: statistics

J Natl Cancer Inst. 2021 Oct 1:djab197. doi: 10.1093/jnci/djab197. Online ahead of print.

ABSTRACT

BACKGROUND: Disease-free and overall survival associations with anthropometric measures of obesity and changes in these exposures remain unknown among endometrial cancer survivors.

METHODS: Endometrial cancer survivors diagnosed between 2002-2006 completed direct anthropometric measurements and self-reported lifetime weight history during in-person interviews approximately 4 months after diagnosis (peri-diagnosis) and approximately 3 years after diagnosis (follow-up). Participants were followed until death or March 20, 2019. Cox proportional regression estimated multivariable-adjusted hazard ratios (HR) and 95% confidence intervals (CI) for body mass index (BMI), weight, waist circumference, and waist-hip ratio with disease-free survival (DFS) and overall survival (OS). Statistical tests were two-sided.

RESULTS: 540 and 425 cancer survivors were assessed peri-diagnosis and follow-up, respectively. During the median 14.2 years of follow-up (range = 0.3-16.5 years), 132 participants had a recurrence and/or died (DFS) with 111 deaths overall (OS). Reduced DFS was noted with greater recalled weight one-year before-diagnosis (HR = 1.88, 95% CI = 1.15 to 3.07), BMI one-year before-diagnosis (HR = 1.88, 95% CI = 1.09 to 3.22), and measured peri-diagnosis BMI (HR = 2.04, 95% CI = 1.18 to 3.53). Measured peri-diagnosis waist circumference ≥88 cm was associated with decreased DFS (HR = 1.94, 95% CI = 1.24 to 3.03) and OS (HR = 1.90, 95% CI = 1.16 to 3.13). A two-fold decrease in DFS and OS was associated with ≥5% BMI or weight change from one-year before diagnosis to peri-diagnosis. No associations were observed for the assessment during follow-up.

CONCLUSION: One-year before- and peri-diagnosis anthropometric measures of obesity were associated with reduced survival among endometrial cancer survivors. Anthropometric changes from one-year before- to peri-diagnosis may provide an important indication of future survival in this population.

PMID:34597394 | DOI:10.1093/jnci/djab197

J Clin Endocrinol Metab. 2021 Oct 1:dgab714. doi: 10.1210/clinem/dgab714. Online ahead of print.

ABSTRACT

CONTEXT: Some studies have suggested that patients with type 2 diabetes mellitus (T2DM) concomitant with obesity have better clinical outcomes than normal-weight patients with T2DM.

OBJECTIVE: We evaluated associations among obesity, cardiovascular disease (CVD) events, and mortality in elderly patients with T2DM without CVD.

DESIGN: Retrospective observational study between 2009 and 2017, with a mean follow-up of 7.26 years.

SETTING: Nationwide (Korea).

PARTICIPANTS: This study included 249,903 elderly (≥65 years) patients with T2DM and no pre-existing CVD using the Korean National Health Information Database.

MAIN OUTCOME MEASURES: We categorized subjects according to body mass index (BMI) and waist circumference (WC) and analyzed a composite of stroke, myocardial infarction, and all-cause death using Cox proportional hazards regression analysis, adjusting for baseline covariates.

RESULTS: The incidence rate of composite primary outcomes was 30.95/1,000 person-years. The primary outcome risk had an L-shaped and a U-shaped association with BMI and WC, respectively. In the multivariable Cox proportional hazard models, the risk of primary composite outcomes in the highest BMI group (≥30 kg/m 2; hazards ratio [HR]=0.824, 95% confidence interval [CI]: 0.794-0.855) was lower than in the normal BMI group (≥18.5 and <23 kg/m 2). Conversely, that in the highest WC group (≥100 cm/≥95 cm; men/women; HR=1.434, 95% CI: 1.384‒1.486) was higher than in the normal WC group (<90 cm/<85 cm; men/women).

CONCLUSION: Our study with elderly patients with diabetes results suggest that while BMI is an inadequate risk indicator for outcomes related to obesity, WC is a suitable alternative.

PMID:34597374 | DOI:10.1210/clinem/dgab714

Blood Adv. 2021 Oct 1:bloodadvances.2020004045. doi: 10.1182/bloodadvances.2020004045. Online ahead of print.

ABSTRACT

In the absence of head-to-head trials, an indirect-treatment comparison can estimate the treatment effect of tisagenlecleucel in comparison with blinatumomab on rates of complete remission (CR) and overall survival (OS) in patients with relapsed or primary refractory (R/R) acute lymphoblastic leukemia (ALL). Patient-level data from two pivotal trials, ELIANA (tisagenlecleucel; n = 79) and MT103-205 (blinatumomab; n = 70), were used in comparisons of CR and OS, controlling for cross-trial difference in available patient characteristics. Five different adjustment approaches were implemented: stabilized inverse probability of treatment weight (sIPTW); trimmed sIPTW; stratification by propensity score quintiles; adjustment for prognostic factors; and adjustment for both prognostic factors and propensity score. Comparative analyses indicate that treatment with tisagenlecleucel was associated with a statistically significant higher likelihood of achieving CR and lower hazard of death than treatment with blinatumomab. The tisagenlecleucel group exhibited a higher likelihood of CR than the blinatumomab group in every analysis regardless of adjustment approach (odds ratios: 6.71-9.76). Tisagenlecleucel was also associated with a lower hazard of death than blinatumomab in every analysis, ranging from 68% to 74% lower hazard of death than with blinatumomab, determined using multiple adjustment approaches (hazard ratios: 0.26-0.32). These findings support the growing body of clinical trial and real-world evidence demonstrating that tisagenlecleucel is an important treatment option for children and young adults with R/R ALL.

PMID:34597381 | DOI:10.1182/bloodadvances.2020004045

Am J Health Syst Pharm. 2021 Oct 1:zxab381. doi: 10.1093/ajhp/zxab381. Online ahead of print.

ABSTRACT

DISCLAIMER: In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

PURPOSE: The purpose of this study was to evaluate the current state of problem list maintenance at an academic medical center.

SUMMARY: We included problem list data for patients who had at least 2 face-to-face encounters at Vanderbilt University Medical Center or its clinics between January 1, 2018, and December 31, 2019. We used the frequency of problem list additions, resolutions, deletions, duplicate problems (exact and SNOMED CT duplicates), inconsistencies (contradicting stages of disease state), and items that could be documented elsewhere in the electronic health record as surrogate markers of problem list maintenance. Descriptive statistics were used to summarize the results. A total of 546,510 patients met inclusion criteria. There were 3,762 (0.7%) patients who had the exact same active problem listed more than once. SNOMED CT code duplications occurred in the records for 56,399 (10.5%) patients. Of the patients with asthma, 2.5% (223/8,779) had contradicting asthma stages active on their problem list, and 6.4% (950/14,950) of patients with chronic kidney disease (CKD) had contradicting CKD stages. In addition, 17,205 (3.1%) patients had 20,365 active family history problems and 39,464 (7.2%) patients had an allergy documented on their problem list. On average, there were 43.7 (95% confidence interval [CI], 14-73.4) additions, 8.7 (95% CI, 0.1-17.4) resolutions, and 2.1 (95% CI, 0-4.6) deletions of problems per 100 face-to-face encounters, inpatient or outpatient.

CONCLUSION: Our study suggests areas for improvement for problem list maintenance. Further studies into semantic duplication and clinical decision support tools to encourage problem list maintenance and deduplication are needed.

PMID:34597358 | DOI:10.1093/ajhp/zxab381

Am J Health Syst Pharm. 2021 Oct 1:zxab383. doi: 10.1093/ajhp/zxab383. Online ahead of print.

ABSTRACT

DISCLAIMER: In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

PURPOSE: The American Society of Health-System Pharmacists (ASHP) and Pediatric Pharmacy Advocacy Group (PPAG) guidelines for providing pediatric pharmacy services in hospitals and health systems can be used to improve medication safety wherever pediatric patients receive care, including in the emergency department (ED). The purpose of this initiative was to improve compliance with these guidelines in a primarily adult ED.

METHODS: This quality improvement initiative was conducted in a level 1 trauma center ED between October 2019 and March 2020. The ASHP-PPAG guidelines were used to create practice elements applicable to the ED. An initial compliance assessment defined elements as noncompliant, partially compliant, fully compliant, or not applicable. Investigators identified interventions to improve compliance for noncompliant or partially compliant elements and then reassessed compliance following implementation. Data were expressed using descriptive statistics. This initiative was exempt from institutional review board approval.

RESULTS: Ninety-three ED practice elements were identified within the 9 standards of the ASHP-PPAG guidelines. At the initial compliance assessment, the majority (59.8%) of practice elements were fully compliant; however, various service gaps were identified in 8 of the standards, and 16 interventions were implemented to improve compliance. At the final compliance assessment, there was a 19.5% increase in full compliance. Barriers to achieving full compliance included technology restrictions, time constraints, financial limitations, and influences external to pharmacy.

CONCLUSION: This quality improvement initiative demonstrated that the ASHP-PPAG guidelines can be used to improve ED pediatric pharmacy services in a primarily adult institution. The initiative may serve as an example for other hospitals to improve compliance with the guidelines.

PMID:34597368 | DOI:10.1093/ajhp/zxab383

PLoS One. 2021 Oct 1;16(10):e0258042. doi: 10.1371/journal.pone.0258042. eCollection 2021.

ABSTRACT

OBJECTIVE: To investigate the perceived-stigma level of COVID-19 patients in the early stage of the epidemic and analysed related factors and correlations that affected the stigma levels.

METHODS: The COVID-19 patients were selected using the convenience sampling method. Perceived-stigma level was evaluated using the Social Impact Scale (SIS). Frequency was used to describe the general information and disease investigation status of COVID-19 patients; mean and standard deviation were used for describing stigma levels, Wilcoxon signed-ranks test (nonparametric test) was applied for pairwise comparison. Kruskal-Wallis non-parametric test for grade data, and Dwass-Steel-Critchlow-Fligner test for multiple comparative analysis. Multiple linear regression analysis was performed, and statistically significant indicators in single-factor analysis were included to investigate the independent factors of stigma. The p<0.05 was considered statistically significant.

RESULTS: SIS score of the 122 COVID-19 patients averaged 57.37±9.99 points. There were statistically significant differences in perceived-stigma levels among patients of different ages (p = 0.008), occupation (p <0.001), marital status (p = 0.009), and disease severity (p = 0.020). Multivariate logistic regression analysis revealed that age was the main influencing factor of stigma (p<0.05).

CONCLUSIONS: The overall perceived-stigma level of COVID-19 patients in the early stage of the epidemic was moderate. Younger, unmarried, and severely ill patients had a higher level of perceived-stigma, with age being the main factor. More attention should be given to the young COVID-19 patients.

PMID:34597354 | DOI:10.1371/journal.pone.0258042

Am J Health Syst Pharm. 2021 Oct 1:zxab382. doi: 10.1093/ajhp/zxab382. Online ahead of print.

ABSTRACT

DISCLAIMER: In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

PURPOSE: Hyperkalemia more commonly affects patients with a glomerular filtration rate of less than 60 mL/min. Using intravenous (IV) insulin to shift potassium intracellularly may cause hypoglycemia, requiring additional treatment or longer hospitalization. Literature on insulin dosing in this context is limited, with one previous study indicating that 5 units of IV insulin might be as effective and result in less hypoglycemia than the standard dose of 10 units of IV insulin. The hyperkalemia treatment pathway at our institution was revised in May 2018 to include a reduced-dose option (5 units of insulin) for patients with end-stage renal disease. This study aimed to compare the prevalence of hypoglycemia between patients who received standard-dose vs reduced-dose IV insulin.

METHODS: This single-center, retrospective, quasi-experimental study evaluated the impact of revision of the hyperkalemia treatment pathway by assessing rates of hypoglycemia during the 6 months before and after implementation of the revised pathway. The primary endpoint was prevalence of hypoglycemia, defined as a blood glucose level of less than or equal to 70 mg/dL.

RESULTS: There was no statistically significant difference in the occurrence of hypoglycemia when comparing the pre- and postimplementation groups (36 [17.7%] patients vs 34 [18.7%] patients; P = 0.7924). The postimplementation group had a statistically significant lower reduction in potassium levels after treatment than the preimplementation group (mean [interquartile range], -0.9 [-1.3, -0.5] mEq/L vs -0.6 [-1.2, -0.2] mEq/L; P = 0.0095). Baseline potassium levels were similar between the groups.

CONCLUSION: Administration of reduced-dose IV insulin for treatment of hyperkalemia was significantly less effective in lowering serum potassium levels and did not decrease prevalence of hypoglycemia. When accounting for potential confounders, the only variable that was associated with hypoglycemia was pretreatment glucose level.

PMID:34597356 | DOI:10.1093/ajhp/zxab382

PLoS One. 2021 Oct 1;16(10):e0258137. doi: 10.1371/journal.pone.0258137. eCollection 2021.

ABSTRACT

Online education, including college English education, has been developing rapidly in the recent decade in China. Such aspects as e-readiness, benefits and challenges of online education were well-researched under normal situations, but fully online language teaching on a large-scale in emergencies may tell a different story. A survey of 2310 non-English-major college students and 149 English teachers from three types of twelve higher education institutions in Wuhan was conducted to evaluate their readiness for online English education during the COVID-19 pandemic, to figure out challenges encountered by them and to draw implications for future online college English education. Quantitative statistics gathered using two readiness scales adapted from previous studies showed that both cohorts were slightly below the ready level for the unexpected online transition of college English education. The overall level of readiness for students was 3.68 out of a score of 5, and that for teachers was 3.70. Individual differences were explored and reported. An analysis of qualitative results summarized six categories of challenges encountered by the students, i.e. technical challenges, challenges concerning learning process, learning environment, self-control, efficiency and effectiveness, and health concern. Though the students reported the highest level of readiness in technology access, they were most troubled by technical problems during online study. For teachers, among three types of challenges, they were most frustrated by pedagogical ones, especially students’ disengagement in online class. The survey brought insights for online college English education development. Institutions should take the initiative and continue promoting the development of online college English education, because a majority of the respondents reported their willingness and intention to continue learning/teaching English in online or blended courses in the post-pandemic period. They are supposed to remove technical barriers for teachers and students, and assess the readiness levels of both cohorts before launching English courses online. Institutions should also arrange proper training for instructors involved, especially about pedagogical issues. Language teachers are suggested to pay special attention to students’ engagement and communication in online courses.

PMID:34597337 | DOI:10.1371/journal.pone.0258137

PLoS One. 2021 Oct 1;16(10):e0258160. doi: 10.1371/journal.pone.0258160. eCollection 2021.

ABSTRACT

BACKGROUND: There was no clear evidence whether the initial dose of enzalutamide affects the incidence of adverse events (AEs), and oncological outcome in patients with castration-resistant prostate cancer (CRPC).

METHODS: The clinical charts of 233 patients with CRPC treated with enzalutamide were reviewed retrospectively. After 1:3 propensity score matching (PSM), 124 patients were divided into a reduced dose group and a standard dose group, and the prostate specific antigen (PSA) response and the incidence of AEs were compared.

RESULTS: 190 patients with CRPC initiated with standard dose enzalutamide were younger and better performance status compared with 43 patients beginning with reduced dose. After PSM, the baseline characteristics were not different between the standard and the reduced dose group. In the PSM cohort, the PSA response rate was significantly lower in the reduced dose group than in the standard dose group (-66.3% and -87.4%, p = 0.02). The incidence rates of AEs were not statistically different between the groups (22.6% and 34.4%, respectively, p = 0.24).

CONCLUSION: Initiating treatment with a reduced dose of enzalutamide did not significantly decrease the incidence rate of AEs, and it showed poorer PSA response rate. There is no clear rationale for treating with a reduced initial dose of enzalutamide to reduce the incidence of AEs.

PMID:34597353 | DOI:10.1371/journal.pone.0258160

PLoS One. 2021 Oct 1;16(10):e0258049. doi: 10.1371/journal.pone.0258049. eCollection 2021.

ABSTRACT

OBJECTIVE: To assess obstetric factors associated with hysterotomy extension among women undergoing a second-stage cesarean.

STUDY DESIGN: This 5-year retrospective cohort study (2013-2017) included all women with second-stage cesarean deliveries of live-born singleton fetuses in cephalic presentation at term. It took place at a tertiary center that practices delayed pushing. We performed univariable and multivariable logistic regression to assess the maternal, obstetric, and neonatal factors associated with hysterotomy extension mentioned in the surgical report. Operative time, postpartum hemorrhage, and maternal complications were also studied.

RESULTS: Of the 3350 intrapartum cesareans, 2637 were performed at term for singleton fetuses in cephalic presentation: 747 (28.3%) during the second stage of labor, 83 (11.1%) of which were complicated by a hysterotomy extension. The median duration of the passive phase of the second stage did not differ between women with and without an extension (164 min versus 160 min, P = 0.85). No other second-stage obstetric characteristics, i.e., duration of the active phase, fetal head station, or fetal malposition, were associated with the risk of extension. Factors significantly associated with extension were the surgeon’s experience and forceps use during the cesarean. Women with an extension, compared to women without one, had a longer median operative time (49 min versus 32 min, P<0.001) and higher rates of postpartum hemorrhage and blood transfusion (respectively, 30.1% versus 15.1%, p = 0.002 and 7.2% versus 2.4%, P = 0.03).

CONCLUSION: The risk of a hysterotomy extension does not appear to be associated with second-stage obstetric characteristics, including the duration of the passive phase of this stage. In our center, which practices delayed pushing, prolonging this passive phase beyond 2 hours does not increase the risk of hysterotomy extension in second-stage cesareans.

PMID:34597319 | DOI:10.1371/journal.pone.0258049