Category: Statistics

Aging (Albany NY). 2024 Apr 3;16. doi: 10.18632/aging.205714. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to investigate whether young patients with endometrial carcinoma can preserve adnexa and lymph nodes to improve their quality of life without compromising their prognosis.

METHODS: A total of 319 patients with type I endometrial carcinoma (high or moderate differentiation and less than 1/2 myometrial invasion) hospitalized in the First Affiliated Hospital of Zhengzhou University from May 2012 to July 2021 were included. The patients were divided into four groups: high differentiation without myometrial invasion group (G1MI-), high differentiation with superficial myometrial invasion group (G1MI+), moderate differentiation without myometrial invasion group (G2MI-), and moderate differentiation with superficial myometrial invasion group (G2MI+). Logistic regression analysis was conducted to identify risk factors for extra-uterine involvement. Kaplan-Meier method was used to draw the survival curve to compare the prognosis in subgroups and rates of extra-uterine involvement were also compared using Chi-square test or Fisher’s exact test.

RESULTS: Multivariable logistic regression revealed that differentiation (HR = 14.590, 95%CI = 1.778-119.754, p = 0.013) and myometrial invasion (HR = 10.732, 95%CI = 0.912-92.780, p = 0.037) were the independent risk factors for extra-uterine involvement. The overall difference was statistically significant (p < 0.001). In the subgroups analysis, both adnexal metastasis and lymph node metastasis were statistically significant in the G2MI+ group compared with G1MI- (p = 0.007, p = 0.008). There were no significant differences in the overall survival (OS) rate and progression free survival (PFS) rate among the four subgroups (p > 0.05).

CONCLUSIONS: Surgery with adnexal preservation and without systematic lymphadenectomy could be employed for the patients who are high differentiation with less than 1/2 myometrial invasion or moderate differentiation without myometrial invasion, but not recommended to the patients with moderate differentiation and superficial myometrial invasion.

PMID:38575312 | DOI:10.18632/aging.205714

BMJ Qual Saf. 2024 Apr 4:bmjqs-2023-016112. doi: 10.1136/bmjqs-2023-016112. Online ahead of print.

ABSTRACT

Mixed methods research is a popular approach used to understand persistent and complex problems related to quality and safety, such as reasons why interventions are not implemented as intended or explaining differential outcomes. However, the quality and rigour of mixed methods research proposals and publications often miss opportunities for integration, which is the core of mixed methods. Achieving integration remains challenging, and failing to integrate reduces the benefits of a mixed methods approach. Therefore, the purpose of this article is to guide quality and safety researchers in planning and designing a mixed methods study that facilitates integration. We highlight how meaningful integration in mixed methods research can be achieved by centring integration at the following levels: research question, design, methods, results and reporting and interpretation levels. A holistic view of integration through all these levels will enable researchers to provide better answers to complex problems and thereby contribute to improvement of safety and quality of care.

PMID:38575310 | DOI:10.1136/bmjqs-2023-016112

Inj Prev. 2024 Apr 4:ip-2023-044959. doi: 10.1136/ip-2023-044959. Online ahead of print.

ABSTRACT

INTRODUCTION: In the USA each year, there are approximately 3400 sudden unexpected infant (<1 year of age) deaths (SUID) which occur without an obvious cause before an investigation. SUID includes the causes of death (COD) undetermined/unknown, sleep-related suffocation/asphyxia and sudden infant death syndrome (SIDS); these are often called SUID subtypes. Three common ways SUID subtypes are grouped (SUID subtype groups) include International Classification of Diseases (ICD) Codes, SUID Case Registry Categories or Child Death Review (CDR)-Assigned Causes. These groups are often used to monitor SUID trends and characteristics at the local, state and national levels. We describe and compare the characteristics of these three SUID subtype groups.

DISCUSSION: SUID subtype groups are distinct and not directly interchangeable. They vary in purpose, strengths, limitations, uses, history, data years available, population coverage, assigning entity, guidance documentation and information available to assign subtypes.

CONCLUSION: Making informed decisions about which SUID subtype group to use is important for reporting statistics, increasing knowledge of SUID epidemiology and informing prevention strategies.

PMID:38575302 | DOI:10.1136/ip-2023-044959

J Nucl Med. 2024 Apr 4:jnumed.123.266188. doi: 10.2967/jnumed.123.266188. Online ahead of print.

ABSTRACT

Amyloid-β (Aβ) accumulation in Alzheimer disease (AD) is typically measured using SUV ratio and the centiloid (CL) scale. The low spatial resolution of PET images is known to degrade quantitative metrics because of the partial-volume effect. This article examines the impact of spatial resolution, as determined by the reconstruction configuration, on the Aβ PET quantitation in both cross-sectional and longitudinal data. Methods: The cross-sectional study involved 89 subjects with 20-min [¹⁸F]florbetapir scans generated on an mCT (44 Aβ-negative [Aβ-], 45 Aβ-positive [Aβ+]) using 69 reconstruction configurations, which varied in number of iteration updates, point-spread function, time-of-flight, and postreconstruction smoothing. The subjects were classified as Aβ- or Aβ+ visually. For each reconstruction, Aβ CL was calculated using CapAIBL, and the spatial resolution was calculated as full width at half maximum (FWHM) using the barrel phantom method. The change in CLs and the effect size of the difference in CLs between Aβ- and Aβ+ groups with FWHM were examined. The longitudinal study involved 79 subjects (46 Aβ-, 33 Aβ+) with three 20-min [¹⁸F]flutemetamol scans generated on an mCT. The subjects were classified as Aβ- or Aβ+ using a cutoff CL of 20. All scans were reconstructed using low-, medium-, and high-resolution configurations, and Aβ CLs were calculated using CapAIBL. Since linear Aβ accumulation was assumed over a 10-y interval, for each reconstruction configuration, Aβ accumulation rate differences (ARDs) between the second and first periods were calculated for all subjects. Zero ARD was used as a consistency metric. The number of Aβ accumulators was also used to compare the sensitivity of CL across reconstruction configurations. Results: In the cross-sectional study, CLs in both the Aβ- and the Aβ+ groups were impacted by the FWHM of the reconstruction method. Without postreconstruction smoothing, Aβ- CLs increased for a FWHM of 4.5 mm or more, whereas Aβ+ CLs decreased across the FWHM range. High-resolution reconstructions provided the best statistical separation between groups. In the longitudinal study, the median ARD of low-resolution reconstructed data for the Aβ- group was greater than zero whereas the ARDs of higher-resolution reconstructions were not significantly different from zero, indicating more consistent rate estimates in the higher-resolution reconstructions. Higher-resolution reconstructions identified 10 additional Aβ accumulators in the Aβ- group, resulting in a 22% increased group size compared with the low-resolution reconstructions. Higher-resolution reconstructions reduced the average CLs of the negative group by 12 points. Conclusion: High-resolution PET reconstructions, inherently less impacted by partial-volume effect, may improve Aβ PET quantitation in both cross-sectional and longitudinal data. In the cross-sectional analysis, separation of CLs between Aβ- and Aβ+ cohorts increased with spatial resolution. Higher-resolution reconstructions also exhibited both improved consistency and improved sensitivity in measures of Aβ accumulation. These features suggest that higher-resolution reconstructions may be advantageous in early-stage AD therapies.

PMID:38575189 | DOI:10.2967/jnumed.123.266188

Can J Surg. 2024 Apr 4;67(2):E158-E164. doi: 10.1503/cjs.006422. Print 2024 Jan-Feb.

ABSTRACT

BACKGROUND: The use of intraoperative diuretics, such as furosemide or mannitol, during kidney transplantation has been suggested to reduce the rate of delayed graft function (DGF). The evidence base for this is sparse, however, and there is substantial variation in practice. We sought to evaluate whether the use of intraoperative diuretics during kidney transplantation translated into a reduction in DGF.

METHODS: We conducted a cohort study evaluating the use of furosemide or mannitol given intraoperatively before kidney reperfusion compared with control (no diuretic). Adult patients receiving a kidney transplant for end-stage renal disease were allocated to receive furosemide, mannitol, or no diuretic. The primary outcome was DGF; secondary outcomes were graft function at 30 days and perioperative changes in potassium levels. Descriptive and comparative statistics were used where appropriate.

RESULTS: A total of 162 patients who received a kidney transplant from a deceased donor (either donation after neurologic determination of death or donation after circulatory death) were included over a 2-year period, with no significant between-group differences. There was no significant difference in DGF rates between the furosemide, mannitol, and control groups. When the furosemide and mannitol groups were pooled (any diuretic use) and compared with the control group, however, there was a significant improvement in the odds that patients would be free of DGF (odds ratio 2.10, 95% confidence interval 1.06-4.16, 26% v. 44%, p = 0.03). There were no significant differences noted in any secondary outcomes.

CONCLUSION: This study suggests the use of an intraoperative diuretic (furosemide or mannitol) may result in a reduction in DGF in patients undergoing kidney transplantation. Further study in the form of a randomized controlled trial is warranted.

PMID:38575180 | DOI:10.1503/cjs.006422

Neurospine. 2024 Apr 4. doi: 10.14245/ns.2448024.012. Online ahead of print.

ABSTRACT

OBJECTIVE: To demonstrate the non-inferiority of the novel hemostatic agent, Hemofence® (BMI Korea Co. Ltd., Jeju Korea, thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety.

METHODS: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For non-inferiority test, a 97.5% one-sided confidence interval was used; the test group was deemed non-inferior if the lower limit exceeded -10%.

RESULTS: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% confidence interval (-4.90%, 7.44%) confirmed the test drug’s non-inferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.0000, p=0.2427, and p=0.9663, respectively).

CONCLUSION: A novel hemostatic agent, Hemofence®, demonstrated an efficacy and safety profile comparable to that of Floseal.

PMID:38575113 | DOI:10.14245/ns.2448024.012

Gene. 2024 Apr 2:148426. doi: 10.1016/j.gene.2024.148426. Online ahead of print.

ABSTRACT

Since late 2019, COVID-19 has significantly impacted the world. Understanding the evolution of SARS-CoV-2 is crucial for protecting against future infectious pathogens. In this study, we conducted a comprehensive chronological analysis of SARS-CoV-2 evolution by examining mutation prevalence from the source countries of VOCs: United Kingdom, India, Brazil, South Africa, plus two countries: United States, Russia, utilizing genomic sequences from GISAID. Our methodological approach involved large-scale genomic sequence alignment using MAFFT, Python-based data processing on a high-performance computing platform, and advanced statistical methods the Maximal Information Coefficient (MIC), and also Long Short-Term Memory (LSTM) models for correlation analysis. Our findings elucidate the dynamics of SARS-CoV-2 evolution, highlighting the virus’s changing behaviour over various pandemic stages. Key results include the discovery of three temporal mutation patterns-lineage distinct, long-span, and competitive mutations-with varying levels of impact on the virus. Notably, we observed a convergence of advantageous mutations in the spike protein, especially in the later stages of the pandemic, indicating a substantial evolutionary pressure on the virus. One of the most significant revelations is the predominant role of natural immunity over vaccination-induced immunity in driving these evolutionary changes. This emphasizes the critical need for regular vaccine updates to maintain efficacy against evolving strains. In conclusion, our study not only sheds light on the evolutionary trajectory of SARS-CoV-2 but also underscores the urgency for robust, continuous global data collection and sharing. It highlights the necessity for rapid adaptations in medical countermeasures, including vaccine development, to stay ahead of pathogen evolution. This research provides valuable insights for future pandemic preparedness and response strategies.

PMID:38575101 | DOI:10.1016/j.gene.2024.148426

World Neurosurg. 2024 Apr 2:S1878-8750(24)00534-5. doi: 10.1016/j.wneu.2024.03.148. Online ahead of print.

ABSTRACT

INTRODUCTION: Depression and anxiety are common in patients undergoing spinal surgery and might negatively impact outcomes. This study investigates the possible effect of these diagnoses on patient reported outcomes following lumbar fusion.

METHODS: Retrospective review of a registry containing prospectively collected data of lumbar fusion procedures at a single institution was performed from 5/23/2012 to 6/15/2022. Patients with a minimum of two year follow up were included. Demographic information, diagnoses,medications, patient-reported outcomes measures (PROMs), and complications data at preoperative, three months, six months, one year, and two years postoperative were collected. Statistical analysis was performed using Student’s T-tests, χ², binomial correlation, odds ratios, logistic regression, and Mean Clinically Important Difference (MCID).

RESULTS: A total of 156 patients were included (60 male, 96 female) with mean age 62.6±11.1 years at surgery. Thirty-nine (25%) had depression and/or anxiety (DA). Baseline Oswestry Disability Index (ODI) and EQ5D scores were significantly worse in the DA cohort compared to controls (ODI 51.1±18.3 vs. 42.9±15.8; p=0.010, EQ5D 0.46±0.21 vs. 0.57±0.21; p=0.005). Both cohorts experienced similar relative improvement at two years (delta ODI -18.2±27.9 vs. -17.8±22.1; p=0.924, EQ5D 6.8±33.8 vs 8.1±32.9; p=0.830). Absolute outcome scores were worse in the DA cohort at all intervals. DA were not independently predictive of changes in PROMs (delta ODI mean difference 4.49, r²=0.36, p=0.924).

CONCLUSION: The present study showed similar improvement in PROMs following lumbar fusion for patients with anxiety and depression compared to healthy controls. These data suggest these patients are no less likely to benefit from appropriately planned lumbar fusion.

PMID:38575064 | DOI:10.1016/j.wneu.2024.03.148

Am J Pharm Educ. 2024 Apr 2:100693. doi: 10.1016/j.ajpe.2024.100693. Online ahead of print.

ABSTRACT

OBJECTIVE: Academic resilience, a critical determinant of academic achievement, is affected by various factors. There is a paucity of large-scale international assessments of academic resilience among pharmacy students. Therefore, this study aimed to assess academic resilience among pharmacy students in twelve countries and to evaluate factors associated with their academic resilience levels.

METHODS: A cross-sectional online survey-based study was conducted among randomly selected pharmacy students in twelve countries: Egypt, Türkiye, Indonesia, Pakistan, Bangladesh, Iraq, Jordan, Nigeria, Malaysia, Saudi Arabia, Sudan, and the United Arab Emirates. After pilot testing, the validated 30-item academic resilience scale (ARS) was used for the assessment. The data was collected between November 1, 2022, and April 15, 2023. Descriptive and inferential statistics were performed as appropriate.

RESULTS: A total of 3950 were received from the twelve participating countries. The mean age was 21.68 ± 2.62 years. About two-thirds of the responses were from female participants and those studying for Bachelor of Pharmacy degrees. Overall, the findings show moderate academic resilience, which varied across countries. The median (IQR) of total ARS-30 was 114 [103-124]. Females exhibited lower negative affective and emotional response subscale levels than males (p = 0.003). There were significant cross-country variations in the ARS-30 and all subscales. The highest overall levels were reported for Sudan, Pakistan, and Nigeria, and the lowest were reported for Indonesia and Türkiye. Students in private universities tended to have higher overall ARS levels than public university students (p = 0.035). Higher academic performance was significantly associated with ARS levels, whereas those with excellent performance exhibited the highest ARS levels (p < 0.001). Students with exercise routines had higher ARS levels (p<0.001) than those with no exercise. Finally, students who were engaged in extracurricular activities had higher ARS levels compared to those who did not participate in these activities (p<0.001).

CONCLUSION: The study offers insights into the factors affecting academic resilience in pharmacy students across several countries. The findings could guide interventions and support activities to improve resilience and academic outcomes.

PMID:38574997 | DOI:10.1016/j.ajpe.2024.100693

J Am Pharm Assoc (2003). 2024 Apr 2:102082. doi: 10.1016/j.japh.2024.102082. Online ahead of print.

ABSTRACT

BACKGROUND: Biosimilars reduce the burden of cost on patients and payers, and so doing, increase access to life-saving care. However, biosimilar uptake in the US has been inconsistent.

OBJECTIVES: This study assessed provider perceptions of barriers to biosimilar use and their relationships to utilization rates in a large, national oncology network and examined if perceptions differed by demographic and practice characteristics.

METHODS: A 28-item survey was administered to 400 network physicians, pharmacists, nurses, and administrators, spanning 25 provider groups, and measured: 1) barriers to use categorized into 4 subscales-payer-related, provider-related, operational, and patient-related, using a Likert scale ranging from Never (1) to Always (5); and 2) demographic and practice characteristics. Utilization rates were assessed using aggregated patient-level drug administration data found in the electronic health record system. Descriptive and inferential statistics were used to describe responses and assess relationships between variables.

RESULTS: A total of 46 responses were analyzed, with a response rate of 11.5%. Most respondents were female (55.6%), physicians (52.2%), with over 6 years of experience (67%). A majority worked in practices participating in the Oncology Care Model (86.7%) and received continuing education on biosimilars (84.8%). Overall scale score was moderately low (mean=2.31), indicating low levels of perceived barriers. The lowest subscale score was operational barriers (mean=2.21), while payer-related barriers was the highest (mean=2.78). Perceptions of barriers did not differ based on demographic and practice characteristics. The average biosimilar utilization rate was 66.2%, with practices in the West administering biosimilars most frequently (71.8%). Utilization was not impacted by perceptions of barriers.

CONCLUSION: Perceived barriers to biosimilar utilization were not common and not associated with utilization. Infrequent impediments to utilization may be associated with network-wide emphasis on continuing education and a value-based care environment. Future research should consider other practice- and patient-level factors that may impact biosimilar utilization.

PMID:38574991 | DOI:10.1016/j.japh.2024.102082