Tag: statistics

Otol Neurotol. 2021 Nov 23. doi: 10.1097/MAO.0000000000003435. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the clinical outcomes of pediatric patients implanted a novel 4.5 mm wide laser ablated titanium bone anchored implant system and to evaluate the implant stability over the first 12-month period.

STUDY DESIGN: A prospective, single-subject, repeated measure, cohort study. Participants served as their own controls.

SETTING: Community and tertiary referral hospital pediatric assessment center.

PATIENTS: A total of 115 consecutive pediatric patients aged 4 to 15 years were implanted with 176 laser ablated titanium bone anchored implants from January 2016 to January 2019.

MAIN OUTCOME MEASURE: Clinical outcomes, implant failure rates, and post implantation implant stability quotient (ISQ) scores were studied over the first 12-month period. Data were analyzed for statistical significance through mixed effect modeling, with the significance level p = 0.01.

RESULTS: A median 12-month survival of 96.6% was observed. Six implants (3.5%) were lost in total, one of these (0.6%) was lost due to trauma. Adverse skin reactions (Holgers grade 2-4) were observed in 4.4% of all postoperative visits, occurring in 22 individuals (19.1%). Neither the ISQ high (ISQH) nor ISQ low (ISQL) values increased significantly between the stage 1 and 2 surgeries. In contrast, the ISQ results, irrespective of abutment size, demonstrated an increasing trend from 49.1 to 57 over the 12 months review period. A statistically significant change was only demonstrated from the 3 months follow up onwards.

CONCLUSION: The use of 4.5 mm wide laser-ablated titanium bone anchored hearing implants resulted in superior survival rates and excellent clinical outcomes compared with previous implant systems.

PMID:34816808 | DOI:10.1097/MAO.0000000000003435

Otol Neurotol. 2021 Nov 23. doi: 10.1097/MAO.0000000000003418. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the audiological and subjective benefit from hearing rehabilitation with an active bone conduction implant in subjects with single-sided sensorineural deafness (SSD).

STUDY DESIGN: Prospective, multicenter, single-subject repeated measures.

SETTING: Tertiary referral center, five clinics in Germany and Switzerland.

PATIENTS: Seventeen subjects aged 18 years and older with severe to profound unilateral sensorineural hearing loss and contralateral normal hearing were followed up for 24 months.

INTERVENTION: Active bone conduction implant.

MAIN OUTCOME MEASURES: Speech understanding in noise was assessed in three situations: with signal from front, deaf, or normal hearing side (with noise from front in all set-ups). Subjective benefit was evaluated using the Speech, Spatial, and Qualities of Hearing (SSQ-B) and Bern Benefit in Single-Sided Deafness (BBSS) questionnaire.

RESULTS: When the signal was coming from the deaf side the mean improvement of the speech reception threshold in noise ranged from 1.5 up to 2.2 dB with the device and was statistically and clinically significant at all tested timepoints. No significant difference between the aided and unaided situation was found when signal and noise were coming from the front. With the signal from the normal hearing side no clinically significant difference, that is, greater than 1 dB between the aided and unaided situation was found. The SSQ-B and BBSS questionnaire showed an overall improvement with no significant difference between time points.

CONCLUSIONS: The study demonstrates long-term efficacy and benefit of the device in adults with SSD. Patients reported substantial and persistent subjective benefit from the active bone conduction implant.

PMID:34816809 | DOI:10.1097/MAO.0000000000003418

Technol Cancer Res Treat. 2021 Jan-Dec;20:15330338211062323. doi: 10.1177/15330338211062323.

ABSTRACT

Objectives: To compare the efficacy of complete transurethral resection of bladder tumor combined with postoperative chemoradiotherapy and radical cystectomy (RC) in the treatment of muscle-invasive bladder cancer (MIBC). Methods: This is a single-center, retrospective study. Clinical data of 125 patients with MIBC admitted to the First Affiliated Hospital of Soochow University from December 2012 to December 2015 were retrospectively analyzed, in which 79 patients (tri-modality therapy [TMT] group) received TMT bladder-sparing treatment, and 41 patients (RC group) received RC. The differences of probabilities for 1-year, 2-year, 5-year, and comprehensive overall survival (OS), progress-free survival (PFS) between 2 groups were calculated using Kaplan-Meier product limited estimates. Univariate and multivariate analyses were performed to detect potential risk factors for OS and PFS. Results: There was no statistical difference between the TMT group and RC group in the 1-year, 2-year, 5-year, comprehensive OS rate, and PFS rate. And survival analysis found no significant difference in OS and PFS between the 2 groups. Univariate analysis showed that age, TNM staging, and prognostic nutritional index (PNI) were associated with OS, while PNI was connected to tumor recurrence. Multiple linear regression analysis indicated that TNM staging and PNI were independent risk factors for OS. Conclusions: TMT can be used as an alternative to RC for MIBC patients under the premise of strict control of indications, rigorous postoperative follow-up, and timely salvage cystectomy. PNI was negatively correlated with OS and PFS, while TNM staging was positively correlated with OS.

PMID:34816789 | DOI:10.1177/15330338211062323

J Healthc Manag. 2021 Nov 23. doi: 10.1097/JHM-D-21-00092. Online ahead of print.

ABSTRACT

GOAL: As strategies emerge to off-load hospital systems and prevent readmissions amid the COVID-19 pandemic, pragmatic assessments of readmission risk become increasingly important. The simplified HOSPITAL score is an extensively validated tool that predicts 30-day potentially avoidable readmission (PAR). Scores of 0 to 4 predict a 30-day PAR risk of 6.4%, while scores ≥ 5 predict a 30-day PAR risk of 17.3%. Its role in patients with COVID-19 is unknown. Our goal was to assess the simplified HOSPITAL score’s accuracy in patients with COVID-19 and explore outcomes related to a hospital-at-home program.

METHODS: Patients discharged following an admission for clinically symptomatic COVID-19 from two hospitals belonging to the same healthcare system in the Midwest were included. Those who died, discharged to hospice or an acute care hospital, whose length of stay was < 1 day, or who discharged against medical advice were excluded. The simplified HOSPITAL score was tabulated for included patients to predict their 30-day PAR risk. The Brier score was calculated to compare the observed rates of 30-day readmission with rates predicted by the simplified HOSPITAL score. Prediction models with a Brier score <.25 are considered useful.

PRINCIPAL FINDINGS: Among 612 patients, the overall 30-day PAR rate was 10.1%. Most patients (n = 522 [85.3%]) had simplified HOSPITAL scores of 0 to 4, and 41 (7.8%) of these patients were readmitted. Among the 90 patients (14.7%) with scores ≥5, 21 (23.3%) were readmitted. The Brier score was 0.088, indicating very good accuracy between the predicted readmission risk and observed readmissions. In patients with scores 0 to 4, readmissions were highest in those discharged to acute or subacute rehabilitation (10.4% [8/77]), intermediate in those discharged home (8.1% [32/394]), and lowest in those discharged to hospital at home (1.9% [1/51]). However, these differences did not reach statistical significance.

APPLICATION TO PRACTICE: The simplified HOSPITAL score was accurate in patients with COVID-19 and can be used to direct resources toward those predicted to be at increased risk for readmission and to assess outcomes from readmission reduction strategies. Hospitals at home may be a promising strategy to decrease readmissions in patients with COVID-19.

PMID:34816806 | DOI:10.1097/JHM-D-21-00092

Stat Methods Med Res. 2021 Nov 24:9622802211055854. doi: 10.1177/09622802211055854. Online ahead of print.

ABSTRACT

Identifying cancer driver genes is essential for understanding the mechanisms of carcinogenesis and designing therapeutic strategies. Although driver genes have been identified for many cancer types, it is still not clear whether the selection pressure of driver genes is homogeneous across cancer subtypes. We propose a statistical framework MutScot to improve the identification of driver genes and to investigate the heterogeneity of driver genes across cancer subtypes. Through simulation studies, we show that MutScot properly controls the type I error in detecting driver genes. In addition, we demonstrate that MutScot can identify subtype heterogeneity of driver genes. Applications to three studies in The Cancer Genome Atlas (TCGA) project showcase that MutScot has a desirable sensitivity for detecting driver genes and that MutScot identifies subtype heterogeneity of driver genes in breast cancer and lung cancer with regards to the status of hormone receptor and to the smoking status, respectively.

PMID:34816788 | DOI:10.1177/09622802211055854

Nat Commun. 2021 Nov 23;12(1):6802. doi: 10.1038/s41467-021-27096-9.

ABSTRACT

In the first wave of the COVID-19 pandemic (April 2020), SARS-CoV-2 was detected in farmed minks and genomic sequencing was performed on mink farms and farm personnel. Here, we describe the outbreak and use sequence data with Bayesian phylodynamic methods to explore SARS-CoV-2 transmission in minks and humans on farms. High number of farm infections (68/126) in minks and farm workers (>50% of farms) were detected, with limited community spread. Three of five initial introductions of SARS-CoV-2 led to subsequent spread between mink farms until November 2020. Viruses belonging to the largest cluster acquired an amino acid substitution in the receptor binding domain of the Spike protein (position 486), evolved faster and spread longer and more widely. Movement of people and distance between farms were statistically significant predictors of virus dispersal between farms. Our study provides novel insights into SARS-CoV-2 transmission between mink farms and highlights the importance of combining genetic information with epidemiological information when investigating outbreaks at the animal-human interface.

PMID:34815406 | DOI:10.1038/s41467-021-27096-9

Sci Rep. 2021 Nov 23;11(1):22756. doi: 10.1038/s41598-021-01950-8.

ABSTRACT

COPD has been regarded as a global epidemic due to an increase in pollution and tobacco exposure. Therefore, the study of molecular mechanism as the basis for modern therapy is important. The aim of the study was the assessment of gene expression levels, IL-6, IL-6ST, PIAS3, STAT3, and miRNAs, miRNA-1, miRNA-106b, miRNA-155, in patients with COPD. Induced sputum as well as PBMC were collected from 40 patients clinically verified according to the GOLD 2021 (A-D) classification and from the control group (n = 20). The levels of gene and miRNA expression were analysed by qPCR. In induced sputum IL6 was significantly down-regulated in COPD group compared with control (p = 0.0008), while IL6ST were up-regulated (p = 0.05). The results were also statistically significant for STAT3 (p = 0.04) and miRNA-155 (p = 0.03) with higher expression in the current smokers compared to ex-smokers. Higher expression levels for IL6ST (p = 0.03) in COPD patients with the exacerbation history compared to COPD patients without the exacerbation history were noted. Compared induced sputum and PB lymphocytes we observed higher expression of IL6 (p = 0.0003), STAT3 (p = 0.000001) miRNA-106b (p = 0.000069 and miRNA-155 (p = 0.000016) in induced sputum with lower expression of PIAS3 (p = 0.006), IL6ST (p = 0.002) and miRNA-1 (p = 0.001). Differences in gene expression levels of the IL-6/IL6ST/STAT3 pathway and miRNA depending on the smoking status and classification of patients according to GOLD suggest the importance of these genes in the pathogenesis of COPD and may indicate their potential utility in monitoring the course of the disease.

PMID:34815425 | DOI:10.1038/s41598-021-01950-8

Sci Data. 2021 Nov 23;8(1):298. doi: 10.1038/s41597-021-01083-7.

ABSTRACT

Autonomous Vehicles (AVs) are being widely tested on public roads in several countries such as the USA, Canada, France, Germany, and Australia. For the transparent deployment of AVs in California, the California Department of Motor Vehicles (CA DMV) commissioned AV manufacturers to draft and publish reports on disengagements and crashes. These reports must be processed before any statistical analysis, which is cumbersome and time-consuming. Our dataset presents the processed disengagement data from 2014 to 2019, crash data till the 10^th of March 2020 and supplementary road network and land-use data extracted from OpenStreetMap. Primary data are manually assessed and converted into an easily processed format. Our processed data will be advantageous to the research community and enable accelerated research in this domain. For example, the data can be utilised to discern trends in disengagement, observe the distribution of disengagement causes, and investigate the contributory factors of the crashes. Such investigations can subsequently improve the reporting protocols and make policies and laws for the smooth deployment of this disruptive technology.

PMID:34815404 | DOI:10.1038/s41597-021-01083-7

Respir Care. 2021 Nov 23:respcare.09518. doi: 10.4187/respcare.09518. Online ahead of print.

ABSTRACT

BACKGROUND: Although quality control standards are recommended to ensure accurate test results, the coefficient of variation for the FVC and FEV₁ biologic quality control (BioQC) is not specified. The primary aim of this study was to evaluate variations in spirometry BioQCs in a large and diverse cohort of individuals to determine an acceptable standard for the coefficient of variation.

METHODS: The FVC and FEV₁ biologic control data were secondary analyses from an inhaled medication trial that was conducted over 3 y ending in 2018 that included 114 laboratories. Results were sent to a central repository for expert review. The FVC and FEV₁ coefficients of variation were based upon a minimum of 10 spirometry values annually separated by at least 5 d. A second method of computing the coefficient of variation used 10 values within 28 d. Descriptive statistics were computed. Wilcoxon signed-rank tests were conducted to compare whether the median coefficient of variation values between the 2 methods differed, tested at α = 0.05 using SPSS.

RESULTS: Of 249 biologic control participants, 170 met the first year’s inclusion criteria. The coefficient of variation for the 5-d separated method was < 5% for 94.1% of FVC and 93.5% of FEV₁ values in the first year. By year 3, 90% of FVC and FEV₁ coefficient of variation values were < 4%. The medians for the 5-d separated and the 28-d measure showed no difference for either FVC coefficient of variation or FEV₁ coefficient of variation, Z = -1.764, P = .78, and Z = -0.980, P = .33, respectively.

CONCLUSIONS: Interlab biologic control variation values of < 4% for FVC and FEV₁ are achievable; however, individual labs should strive to attain lower values. Acceptable coefficients of variation can be achieved within 28 d.

PMID:34815323 | DOI:10.4187/respcare.09518

Postgrad Med J. 2021 Nov 23:postgradmedj-2021-140835. doi: 10.1136/postgradmedj-2021-140835. Online ahead of print.

ABSTRACT

BACKGROUND: To explore the potential risk factors predicting malignancy in patients with indeterminate incidental mammographic microcalcification and to evaluate the short-term risk of developing malignancy.

METHODS: Between January 2011 and December 2015, one hundred and fifty (150) consecutive patients with indeterminate mammographic microcalcifications who had undergone stereotactic biopsy were evaluated. Clinical and mammographic features were recorded and compared with histopathological biopsy results. In patients with malignancy, postsurgical findings and surgical upgrade, if any, were recorded. Linear regression analysis (SPSS V.25) was used to evaluate significant variables predicting malignancy. OR with 95% CIs was calculated for all variables. All patients were followed up for a maximum of 10 years. The mean age of the patients was 52 years (range 33-79 years).

RESULTS: There were a total of 55 (37%) malignant results in this study cohort. Age was an independent predictor of breast malignancy with an OR (95% CI) of 1.10 (1.03 to 1.16). Mammographic microcalcification size, pleomorphic morphology, multiple clusters and linear/segmental distribution were significantly associated with malignancy with OR (CI) of 1.03 (1.002 to 1.06), 6.06 (2.24 to 16.66), 6.35 (1.44 to 27.90) and 4.66 (1.07 to 20.19). The regional distribution of microcalcification had an OR of 3.09 (0.92 to 10.3), but this was not statistically significant. Patients with previous breast biopsies had a lower risk of breast malignancy than patients with no prior biopsy (p=0.034).

CONCLUSION: Multiple clusters, linear/segmental distribution, pleomorphic morphology, size of mammographic microcalcifications and increasing age were independent predictors of malignancy. Having a previous breast biopsy did not increase malignancy risk.

PMID:34815330 | DOI:10.1136/postgradmedj-2021-140835