Tag: statistics

Ophthalmic Surg Lasers Imaging Retina. 2023 Mar;54(3):153-157. doi: 10.3928/23258160-20230217-01. Epub 2023 Mar 1.

ABSTRACT

BACKGROUND AND OBJECTIVE: The aim of this study was to evaluate the interobserver agreement of the myopic traction maculopathy (MTM) staging system (MSS).

PATIENTS AND METHODS: Each observer was asked to look at the MSS Table and then identify, in each optical coherence tomography scan, one among four stages of MTM in the retina, one among three stages in the fovea, and, as secondary findings, the presence or absence of an outer lamellar macular hole and the presence or absence of epiretinal abnormalities. The interobserver agreement value was calculated using the Gwet’s AC1 unweighted and AC2 weighted statistics. The outcomes were interpreted as poor (<0.00), slight (0.00 to 0.20), fair (0.21 to 0.40), moderate (0.41 to 0.60), substantial (0.61 to 0.80), or almost perfect (0.81 to 1.00) agreement.

RESULTS: The agreement, among 65 participants, was 0.62 (AC1) and 0.77 (AC2) for the retina stage; 0.63 (AC1) and 0.81 (AC2) for the fovea stage; 0.56 (AC1) for the outer lamellar macular hole; and 0.26 (AC1) for epiretinal abnormalities.

CONCLUSION: The MSS is highly reproducible and helps ophthalmologists to share information on MTM in a more accurate and reliable way. [Ophthalmic Surg Lasers Imaging Retina 2023;54(3):153-157.].

PMID:36944066 | DOI:10.3928/23258160-20230217-01

Urogynecology (Phila). 2022 Dec 23. doi: 10.1097/SPV.0000000000001300. Online ahead of print.

ABSTRACT

IMPORTANCE: Bladder hydrodistention (BH) is commonly used to diagnose and treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS), but the overall assessment of bleeding complications for patients taking antithrombotics is lacking.

OBJECTIVES: The study aimed to investigate if perioperative complications were more common in patients with IC/BPS receiving antithrombotic therapy after BH.

STUDY DESIGN: We retrospectively reviewed patients with IC/BPS who underwent hydrodistention during January 2010 and May 2021. Patients with and without antithrombotic drugs were identified and grouped, and their medical records were reviewed. Perioperative data and symptom scores were assessed. The rates of complications in the 2 groups were recorded at 3 months and at the last visit postoperatively.

RESULTS: A total of 387 patients were eventually included. Among them, 29 (7.5%) patients were receiving systemic antithrombotic therapy and 358 (92.5%) were not. Compared with the non-antithrombotic group, patients receiving antithrombotic therapy demonstrated a longer hospital stay (P = 0.033) and a longer catheterization time (P = 0.034). Moreover, the patients with antithrombotic drugs had increased odds of bladder tamponade (odds ratio, 6.76; P = 0.019) and urinary retention (odds ratio, 5.79; P = 0.033) both 3 months postoperatively and last follow-up, but this is not statistically different between patients with and without Hunner lesions. No thromboembolic events were identified during the study period.

CONCLUSIONS: Although a small number of patients with IC/BPS needed anticoagulants, longer hospital stays, longer catheterization time, and increased odds of bladder tamponade and urinary retention were observed in patients receiving antithrombotic therapy. Still, a comprehensive management scheme to balance bleeding complications and antithrombotic agents is needed for individuals.

PMID:36944055 | DOI:10.1097/SPV.0000000000001300

Ann Fam Med. 2022 Apr 1;(20 Suppl 1). doi: 10.1370/afm.20.s1.2920.

ABSTRACT

Context: At the mid-point of the COVID-19 pandemic, polymerase chain reaction (PCR) testing for SARS-CoV-2 was difficult to obtain and took several days to return a result. Our health system wished to explore the use of the Quidel Sofia™ antigen test to diagnose COVID-19 in our primary care clinics, but the test was approved for emergency use authorization by the US Food and Drug Administration with only 250 test subjects. In addition, because it was important to avoid aerosol generating procedures in primary care clinics, it was necessary to test the diagnostic performance of the antigen test using mid-turbinate (MT) swabs rather than the approved nasopharyngeal (NP) swab technique. Objective: To assess the diagnostic test characteristics of a SARS-CoV-2 antigen test performed using mid-turbinate nasal swabs compared with the presumed reference standard PCR test by NP swab. Study Design: Prospective cohort study. Setting or Dataset: Outpatient. Population studied: Adults with symptoms consistent with mild-moderate COVID-19. We attempted to recruit 800 subjects to provide statistical assurance that the test sensitivity was at least 90%. Intervention/Instrument: After informed consent, subjects underwent MT nasal swab for antigen testing followed by NP swabbing for PCR testing. Outcome Measures: Sensitivity, specificity, positive and negative predictive values, and likelihood ratios, all with associated 95% confidence intervals. Results: Due to recruitment difficulty (subject reluctance and staffing issues at the testing centers), we recruited only 117 subjects. Sensitivity was 0.750 (95% CI 0.566, 0.885), and specificity was 0.988 (95% CI 0.936, 1.000). Positive Predictive Value was 0.960 (95% CI 0.796, 0.999) and Negative Predictive Value was 0.913 (95% CI 0.836, 0.962). The likelihood ratio for a positive test was 63.75 (95% CI 8.99, 451.97) and the likelihood ratio for a negative test was 0.25 (95% CI 0.14, 0.46). Conclusions: This antigen test for SARS-CoV-2 was of reasonable clinical utility in a low prevalence environment but concerns about the actual prevalence of COVID-19 and the ramifications of false negatives limited its use. Difficulty recruiting subjects and the resultant delay in the results made it impossible to implement this antigen testing in primary care practices, but it is hoped that these data will contribute to the accumulation of evidence about diagnostic testing for COVID-19.

PMID:36944042 | DOI:10.1370/afm.20.s1.2920

Med Glas (Zenica). 2023 Aug 1;20(2). doi: 10.17392/1566-23. Online ahead of print.

ABSTRACT

Aim To determine the value of angles between the left coronary artery main trunk (LMT) and its branches, the anterior interventricular branch (LAD) and the circumflex branch (CX), and their possible relationship with the LMT length. Methods A total of 29 cadaveric hearts were used. The left coronary artery and its branches were dissected. The hearts were then classified according to the number of branches. The LMT length was measured with a digital gauge, and the LAD-CX angle, LMTLAD angle and LMT-CX angle with a manual goniometer. Results The average value of the LMT length was 9.0 mm (6.0-13.5). In 20 (68.97%) samples, the LMT was divided into two terminal branches. There was no statistically significant difference (p=0.321) in LMT length between the hearts with a bifurcation and without it. The average value of the LAD-CX angle was 89.0⁰ (74.5-93.0), with a statistically significant difference (p=0.020) comparing to hearts with trifurcation. The mean value of the LMT-LAD angle was 30.83±9.23⁰ and it was significantly lower (p=0.006) in the group of hearts with bifurcation compared to the group with trifurcation of the main trunk. Conclusion The LMT length shows great variability and is not related to the LAD-CX, LMT-LAD or the LMT-CX angle. Knowledge of the left coronary variation is essential in order to avoid misinterpretation of arteriogram.

PMID:36944018 | DOI:10.17392/1566-23

Circ Cardiovasc Interv. 2023 Mar;16(3):e012623. doi: 10.1161/CIRCINTERVENTIONS.122.012623. Epub 2023 Mar 21.

ABSTRACT

BACKGROUND: Transcatheter aortic valve replacement is approved for treatment of patients with severe aortic stenosis across the spectrum of risk. While considering broader indications for use, transcatheter aortic valve replacement in large native annuli has become increasingly important.

METHODS: Patients with tricuspid aortic stenosis undergoing transcatheter aortic valve replacement using the Evolut R or Evolut PRO+ 34 mm valves (Medtronic, Minneapolis, MN) in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry between October 2016 and September 2020 were stratified according to in range (>12%) device oversizing and below range (0%-12%) device oversizing. Patients undergoing valve-in-valve procedures, having a baseline annulus size <26 or ≥34 mm, or without computed tomography angiography measured annulus size were excluded. Percentage of oversizing was calculated as [(valve diameter-annulus diameter)×100/annulus diameter].

RESULTS: Transcatheter aortic valve replacement in patients with large annuli was performed in 8017 patients with a mean (±SD) age 79.3±7.9 years and 94% were male. Below range (n=1096) was less common than in range oversizing (n=6921). At 1-year follow-up, mortality (19.6% versus 14.9%; P=0.001), aortic valve reintervention (2.1% versus 0.6%; P<0.001) and valve-related readmission rates (3.2% versus 2.0%; P=0.014) were higher in the below range device oversizing group versus in range group respectively. In a multivariable Cox proportional hazards regression model, when controlling for clinically relevant covariates, below range device oversizing was associated with higher 1-year all-cause mortality (HR, 1.28 [CI, 1.07-1.51]; P=0.005).

CONCLUSIONS: Results from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry in patients with large annuli valves using 34mm Evolut R/PRO+ valves suggest that in range (>12%) device oversizing delivered better clinical outcomes than implantation with below range (0%-12%) device oversizing.

PMID:36943929 | DOI:10.1161/CIRCINTERVENTIONS.122.012623

Cancer. 2023 Mar 21. doi: 10.1002/cncr.34748. Online ahead of print.

ABSTRACT

BACKGROUND: The 5-year overall survival of pancreas adenocarcinoma (PCa) remains less than 10%. Clinical and tumor genomic characteristics have not differentiated PCa long-term survivors (LTSs) from unselected patients. Preclinical studies using fecal transplant experiments from LTSs of PCa have revealed delayed tumor growth through unknown mechanisms involving the fecal microbiota. However, features of the fecal microbiome in patients with long-term survival are not well described.

METHODS: In this cross-sectional study, comprehensive shotgun metagenomics was performed on stool from PCa patients with long-term survival (n = 16). LTS was defined as >4 years from pancreatectomy and all therapy without recurrence. LTSs were compared to control patients with PCa who completed pancreatectomy and chemotherapy (n = 8). Stool was sequenced using an Illumina NextSeq500. Statistical analyses were performed in R with MicrobiomeSeq and Phyloseq for comparison of LTSs and controls.

RESULTS: All patients underwent pancreatectomy and chemotherapy before sample donation. The median time from pancreatectomy of 6 years (4-14 years) for LTSs without evidence of disease compared to a median disease-free survival of 1.8 years from pancreatectomy in the control group. No differences were observed in overall microbial diversity for LTSs and controls using Shannon/Simpson indexes. Significant enrichment of species relative abundance was observed in LTSs for the Ruminococacceae family specifically Faecalibacterium prausnitzii species as well as Akkermansia mucinophilia species.

CONCLUSIONS: Stool from patients cured from PCa has more relative abundance of Faecalibacterium prausnitzii and Akkermansia mucinophilia. Additional studies are needed to explore potential mechanisms by which the fecal microbiota may influence survival in PCa.

PLAIN LANGUAGE SUMMARY: Although pancreatic cancer treatments have improved, the number of long-term survivors has remained stagnant with a 5-year overall survival estimate of 9%. Emerging evidence suggests that microbes within the gastrointestinal tract can influence cancer response through activation of the immune system. In this study, we profiled the stool microbiome in long-term survivors of pancreas cancer and controls. Several enriched species previously associated with enhanced tumor immune response were observed including Faecalibacterium prausnitzii and Akkermansia mucinophilia. These findings warrant additional study assessing mechanisms by which the fecal microbiota may enhance pancreatic cancer immune response.

PMID:36943918 | DOI:10.1002/cncr.34748

Infect Dis (Lond). 2023 Mar 21:1-9. doi: 10.1080/23744235.2023.2190813. Online ahead of print.

ABSTRACT

BACKGROUND: Pyogenic liver abscess (PLA) is a rare but potentially life-threatening disease, and estimates suggest a gradual increase in the incidence during the last decades. The primary aim of this study was to report the incidence, trend and aetiology of PLA during a decade in Southern Sweden.

METHODS: This was a population-based observational cohort study between 2011 and 2020 in Skåne, Southern Sweden. Data were retrieved from the Swedish National Board of Health and Welfare for all individuals diagnosed with liver abscess (K750) according to ICD-10 (International Statistical Classification of Diseases, 10th revision).

RESULTS: A total of 456 episodes of PLA occurred in 364 patients during the study period. The median age of the first PLA episode was 71 years (range 3-97) and 57% (n = 206) were men. The mean incidence of all patients was 3.4/100,000 person-years (range 1.8-5.2). The incidence increased almost three times, from 1.8/100,000 person-years in 2011 to 5.2/100,000 person-years in 2020. Streptococcus species, Escherichia coli and Klebsiella species accounted for the vast majority of both mono- and polymicrobial findings in both blood and local abscess cultures. 16s rDNA added information about aetiology in 37% of episodes.

CONCLUSION: The incidence of PLA increased during the study period, and Streptococcus spp., Klebsiella spp. and E. coli dominated both blood and local cultures. Despite antimicrobial therapy, pathogens could be found in local abscess cultures several weeks into treatment. Increased use of 16s rDNA in the management of PLA could be beneficial.

PMID:36943906 | DOI:10.1080/23744235.2023.2190813

Proc Natl Acad Sci U S A. 2023 Mar 28;120(13):e2214525120. doi: 10.1073/pnas.2214525120. Epub 2023 Mar 21.

ABSTRACT

Diagnosing dynamical changes in the climate system, such as those in atmospheric circulation patterns, remains challenging. Here, we study 1950 to 2021 trends in the frequency of occurrence of atmospheric circulation patterns over the North Atlantic. Roughly 7% of atmospheric circulation patterns display significant occurrence trends, yet they have major impacts on surface climate. Increasingly frequent patterns drive heatwaves across Europe and enhanced wintertime storminess in the northern part of the continent. Over 91% of recent heatwave-related deaths and 33% of high-impact windstorms in Europe were concurrent with increasingly frequent atmospheric circulation patterns. While the trends identified are statistically significant, they are not necessarily anthropogenic. Atmospheric patterns which are becoming rarer correspond instead to wet, cool summer conditions over northern Europe and wet winter conditions over continental Europe. The combined effect of these circulation changes is that of a strong, dynamically driven year-round warming over most of the continent and large regional and seasonal changes in precipitation and surface wind.

PMID:36943887 | DOI:10.1073/pnas.2214525120

J Cosmet Dermatol. 2023 Mar 21. doi: 10.1111/jocd.15730. Online ahead of print.

ABSTRACT

BACKGROUND: Oxidative damage is one of the major mechanisms of ultraviolet B (UVB)-induced damage to the skin. Maslinic acid (MA) is a natural compound of pentacyclic triterpene acids. It has been proved to have anti-inflammatory and antioxidant properties.

OBJECTIVE: This study aimed to explore the effects of MA on oxidative damage in human foreskin fibroblast cells (HFF-1) and the potential molecular mechanisms.

METHODS: A specific dose of UVB radiation was used to induce oxidative damage in HFF-1. Based on this, we performed measurements of cell proliferation, reactive oxygen species (ROS) levels, antioxidant enzyme activity, inflammation-related mediators, and NF-κB nuclear localization with or without the addition of MA.

RESULTS: MA significantly promoted cell proliferation viability at 10 and 20 μM. The addition of MA 24 h before UVB irradiation was more effective at enhancing cell proliferation and also produced lower ROS levels compared to co-cultured fibroblasts and MA for 24 h after irradiation. However, there was no statistically significant difference between groups at concentrations of 10 and 20 μM. The pretreatment group with MA had elevated superoxide dismutase and catalase activities, decreased IL-6 generation, and lowered mRNA levels of IL-6, TNF-α and MMP3 in comparison with the UVB-irradiated group without additional MA. Meanwhile, the nuclear translocation of NF-κB and the degradation of IκB were inhibited by MA pretreatment.

CONCLUSION: Taken together, these findings suggest that MA may alleviate UVB-induced oxidative damage in HFF-1 by inhibiting the nuclear translocation of NF-κB.

PMID:36943873 | DOI:10.1111/jocd.15730

Oncologist. 2023 Mar 21:oyad024. doi: 10.1093/oncolo/oyad024. Online ahead of print.

ABSTRACT

BACKGROUND: Hyperglycemia is recognized as a common adverse event for patients receiving alpelisib but has been little studied outside of clinical trials. We report the frequency of alpelisib-associated hyperglycemia in a real-world setting and evaluate proposed risk factors.

PATIENTS AND METHODS: We retrospectively identified patients with PIK3CA-mutated, hormone receptor-positive, metastatic breast cancer who initiated treatment with alpelisib plus fulvestrant between August 2019 and December 2021. Ordinal logistic regression evaluated 5 characteristics (diabetes, prediabetes, body mass index [BMI], age, and Asian ancestry) as independent risk factors for ALP-associated hyperglycemia grades 2-4. Risk of error from multiple hypothesis testing was controlled using the false discovery rate method.

RESULTS: The study included n = 92 subjects, all but 1 female, mean age 59.9 (+11.9) years with 50% non-Hispanic White, 15% Hispanic/Latino, 13% Asian, 9% African/Black, and 13% other/unknown. In total 34% of patients had diabetes, 10% had pre-diabetes, and 56% had normoglycemia. Thirty-six percent were obese, 32% were overweight, 25% were normal weight, and 7% were lean. Frequency of grades 1-4 hyperglycemia in current subjects (64.1%) was similar to hyperglycemia reported in the SOLAR-1 trial (63.7%). Our subjects’ risk of grades 2-4 hyperglycemia was independently increased by pre-existing diabetes (Odds ratio 3.75, 95% CI, 1.40-10.01), pre-diabetes (6.22, 1.12-34.47), Asian ancestry (7.10, 1.75-28.84), and each unit of BMI above 20 (1.17, 1.07-1.28).

CONCLUSION: While receiving alpelisib, patients of Asian ancestry, as well as patients with pre-existing hyperglycemia and/or BMI above 20, should be closely monitored for hyperglycemia. The mechanism underlying the current association of alpelisib-associated hyperglycemia with Asian ancestry is independent of BMI and merits further study. The high incidence of hyperglycemia resulted in a change in practice to include consultation with a diabetes nurse educator or endocrinologist at the start of alpelisib.

PMID:36943382 | DOI:10.1093/oncolo/oyad024