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Nevin Manimala Statistics

Denosumab prevents acetabular bone loss around an uncemented cup: analysis of secondary outcomes in a randomized controlled trial

Acta Orthop. 2022 Sep 7;93:709-720. doi: 10.2340/17453674.2022.4537.

ABSTRACT

BACKGROUND AND PURPOSE: Uncemented total hip arthroplasty (THA) is associated with periprosthetic bone loss. In a secondary outcome analysis from a randomized controlled trial, we studied whether denosumab can prevent loss of acetabular periprosthetic bone mineral density (pBMD) in patients who received a trabecular metal cup during uncemented THA.

PATIENTS AND METHODS: 64 patients (aged 35-65 years) with unilateral osteoarthritis of the hip were randomized to 2 subcutaneous injections with denosumab or placebo, given 1-3 days post-surgery and 6 months post-surgery. Acetabular pBMD was measured in 5 regions of interest (ROIs) by dual-energy X-ray absorptiometry. Serum markers for bone metabolism were analyzed. Periprosthetic osteoblastic activity, measured as standardized uptake values (SUVs) by [18F] positron emission tomography/computed tomography, was evaluated in 32 of the 64 study patients.

RESULTS: After 12 months, patients treated with denosumab had higher pBMD compared with the placebo-treated patients in 4 of 5 ROIs and in sum of ROIs 1-5. After 24 months, the effect on pBMD for patients treated with denosumab declined. Serum markers declined pronouncedly up to 12 months in patients treated with denosumab, but rebounded above baseline levels after 24 months. Patients treated with denosumab had statistically significantly lower SUVs in all ROIs, except ROI 5, after 6 months.

INTERPRETATION: Based on this exploratory analysis of secondary endpoints the application of denosumab seems associated with preserved acetabular pBMD, reduced bone metabolism and attenuated periprosthetic osteoblastic activity. However, given the known rebound affects after discontinuation of denosumab treatment, these effects cannot be expected to persist. If prolonged treatment or shift to other regimes would be beneficial to reduce the risk of cup loosening is yet to be investigated.

PMID:36069479 | DOI:10.2340/17453674.2022.4537

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Estimation of the segmental left ventricular physical and mechanical parameters using echocardiographic imaging for stent candidate patients

J Clin Ultrasound. 2022 Sep 7. doi: 10.1002/jcu.23324. Online ahead of print.

ABSTRACT

PURPOSE: Left ventricular (LV) dysfunction can be assessed by quantifying LV structure. In this study, physical parameters were extracted, including the systolic strain, wall stress, and elastic modulus of LV to diagnose stent candidate patients from the control group.

METHODS: Based on angiography results, 88 patients with coronary artery disease (CAD) were divided into 64 patients candidates for PCI (percutaneous coronary intervention) and 24 patients in the control group. With the thick-walled ellipsoidal model, the passive wall stresses at end-systole and end-diastole were estimated. Regional circumferential strain and regional longitudinal strain were obtained by speckle tracking technique.

RESULTS: The inferoseptal circumferential wall stress in end-systole was statistically significant for the PCI group compared to the control group (p = .026). Anterior and inferoseptal circumferential strain for the PCI group (-17.25 ± 4.22 and -18.21 ± 4.04%) compared to the control group (-21.71 ± 4.74 and 20.58 ± 3.04%) were statistically significant, respectively (p = .000 and p = .011). Anterior and inferoseptal circumferential elastic modulus were statistically significant (p = .000 and p = .005). The receiver operator characteristic (ROC) curve analysis revealed that anterior and inferoseptal circumferential elastic modulus had the highest area under the curve with 76.6% sensitivity, 83.3% specificity for anterior circumferential, 68.8% sensitivity, and 70.8% specificity for inferoseptal circumferential, for the diagnosis of stent candidate patients.

CONCLUSIONS: Regional elastic modulus parameter is suggested as a noninvasive and quantitative method for measuring LV function. Strain and stress parameters using the STE method and geometrical model can be helpful for diagnostic stent candidate patients.

PMID:36069427 | DOI:10.1002/jcu.23324

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Efficacy of neoadjuvant chemotherapy in male breast cancer compared with female breast cancer

Cancer. 2022 Sep 7. doi: 10.1002/cncr.34448. Online ahead of print.

ABSTRACT

BACKGROUND: Neoadjuvant chemotherapy (NAC) is standard for many females with breast cancer (FBC). The efficacy of NAC in male breast cancer (MaBC) is unclear. The aim of this study was to compare proportions of pathologic complete response (pCR) between MaBC and FBC by tumor subtype (TS).

METHODS: MaBC and FBC treated with NAC between 2010 and 2016, with known TS, were evaluated from the National Cancer Database. Proportions of pCR (ypT0/Tis ypN0) were compared between sexes within TS by Fisher test. Multivariable logistic regression assessed the independent association of sex with pCR. Overall survival (OS) was estimated by Kaplan-Meier.

RESULTS: A total of 385 MaBC and 68,065 FBC were included. Median time from initiation of NAC to surgery was 143 days in MaBC and 148 days in FBC. Proportions of pCR in MaBC and FBC by TS were: hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-): 4.9% vs 9.7%, p = .01; HR+/HER2+: 16.1% vs 33.6%, p < .001; HR-/HER2+: 44.0% vs 53.2%, p = .42; and HR-/HER2-: 21.4% vs 32.1%, p = .18, respectively. FBC had twice the odds of pCR than MaBC (adjusted odds ratio, 2.0; 95% CI, 1.5-2.8; p < .001). Five-year OS for MaBC with pCR vs not was 90% vs 64.7%; p = .02. Five-year OS for FBC with pCR vs not was 91.9% vs 75.3%; p < .01.

CONCLUSIONS: Proportions and odds of pCR to NAC were numerically lower in MaBC compared with FBC for each TS and statistically significant for HR+/HER2- and HR+/HER2+. The independent association of sex with pCR was confirmed in multivariable analysis. pCR is prognostic in both MaBC and FBC.

PMID:36069365 | DOI:10.1002/cncr.34448

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Association Between ABO Blood Group System and COVID-19 Severity

Am J Clin Pathol. 2022 Sep 7:aqac106. doi: 10.1093/ajcp/aqac106. Online ahead of print.

ABSTRACT

OBJECTIVES: A possible association between blood group systems (ABO and Rh) and coronavirus disease 2019 (COVID-19) severity has recently been investigated by various studies with conflicting results. However, due to variations in the prevalence of the ABO and Rh blood groups in different populations, their association with COVID-19 might be varied as well. Therefore, we conducted this study on Libyan participants to further investigate this association and make population-based data available to the worldwide scientific community.

METHODS: In this case-control study, ABO and Rh blood groups in 419 confirmed COVID-19 cases in Zawia, Libya, and 271 healthy controls were compared using descriptive statistics and χ 2 tests.

RESULTS: Blood group A was significantly more prevalent in patients with severe COVID-19 (64/125; 51.2%) than in patients with nonsevere COVID-19 (108/294, 36.7%) (P < .034), whereas the O blood group prevalence was higher in nonsevere COVID-19 cases (131/294, 44.5%) compared with severe cases (43/125, 34.4%) (P < .001).

CONCLUSIONS: The results showed a significant association between blood group A and the severity of COVID-19, whereas patients with blood group O showed a low risk of developing severe COVID-19 infection. No significant association was found between Rh and susceptibility/severity of the disease.

PMID:36069364 | DOI:10.1093/ajcp/aqac106

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Epidemiologic outlook of therapy-related myeloid neoplasms and selection of high-risk patients: A Korean nationwide study

Cancer. 2022 Sep 7. doi: 10.1002/cncr.34453. Online ahead of print.

ABSTRACT

BACKGROUND: Although a considerable proportion of patients with cancer receive chemotherapy (CT) or radiotherapy (RT), only a very few patients eventually develop therapy-related myeloid neoplasms (t-MNs).

METHODS: To identify subsets of cancer patients who have substantially elevated risk of developing t-MNs. Incidences and risks of t-MNs after contemporary CT or RT in patients newly diagnosed major cancers during 2009-2013 were analyzed. By merging two Korean nationwide health care big data sets, patients were selected and observed on follow-up to until t-MN development or December 2019.

RESULTS: Among 250,155 patients, 555 (0.22%) were diagnosed with t-MNs with a standard incidence ratio (SIR) of 3.40 (95% CI, 3.13-3.70). Patients had bone/joint cancers (SIR, 94.25; 95% CI, 50.71-137.80) and a remarkably high SIR for t-MN development. Patients receiving both CT and RT had the highest SIR (4.64; 95% CI, 4.08-5.20), followed by those receiving CT only (SIR, 3.30; 95% CI, 2.89-3.70). Contrarily, RT alone did not increase t-MN risk (SIR, 1.16; 95% CI, 0.76-1.56). More exposure to leukemogenic agents resulted in the higher t-MNs development.

CONCLUSIONS: The increased risk of developing acute myeloid leukemia or myelodysplastic syndrome after CT and/or RT was confirmed and subsets with substantially elevated risk for developing t-MNs were found. Such patients would be suitable for a prospective cohort for investigating t-MN pathogenesis by time series analyses.

PMID:36069361 | DOI:10.1002/cncr.34453

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The discriminatory ability of FibroScan liver stiffness measurement, controlled attenuation parameter, and FibroScan-aspartate aminotransferase to predict severity of liver disease in children

Hepatol Commun. 2022 Sep 7. doi: 10.1002/hep4.1983. Online ahead of print.

ABSTRACT

Vibration controlled transient elastography (FibroScan) is used to predict the severity of liver fibrosis and steatosis. In pediatrics, few studies have been performed directly comparing liver histologic features with FibroScan liver stiffness measurements (LSMs) and controlled attenuation parameters (CAPs). The FibroScan-aspartate aminotransferase (FAST) score, which predicts liver disease severity in adult nonalcoholic fatty liver disease (NAFLD), has not been analyzed in children. The aims of this study were to determine if LSM and CAP correlated with liver histologic fibrosis stage and steatosis grade, respectively, and to determine the predictive capacity of FAST in pediatric NAFLD. Research participants (n = 216) included those with FibroScan within 90 days of a liver biopsy. The ability of LSM, CAP, and FAST to predict severity of liver disease was analyzed by Spearman correlation, linear regression, and receiver operating characteristic and C statistic. Significant correlations were identified between LSM and Ishak fibrosis stages, with the strongest correlation occurring in the non-NAFLD group (Spearman r = 0.47, p < 0.0001). LSM adequately predicted Ishak stages F0-2 versus F3-F6 (area under the receiver operating characteristic curve [AUROC], 0.73 for all; 0.77 for non-NAFLD). CAP strongly predicted histologic steatosis grade (r = 0.84; p < 0.0001; AUROC, 0.98). FAST had acceptable discriminatory ability for significant liver disease (AUROC, 0.75). A FAST cutoff ≥0.67 had a sensitivity of 89% but a specificity of only 62% at determining significant liver disease. This study encompasses one of the largest pediatric cohorts describing the accuracy of FibroScan LSM and CAP to predict liver histologic fibrosis stage and steatosis grade, respectively. In order to determine specific LSM, CAP, and FAST cut-off values for fibrosis stages, steatosis grades, and significant liver disease, respectively, a much larger cohort is necessary and will likely entail the need for multicentered studies.

PMID:36069338 | DOI:10.1002/hep4.1983

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Prognostic factors and outcomes in minimal access resections of skull base and sinonasal epithelial malignancy

ANZ J Surg. 2022 Sep 7. doi: 10.1111/ans.18022. Online ahead of print.

ABSTRACT

BACKGROUND: Sinonasal epithelial malignancies are uncommon tumours but represent a challenge to treatment given their close proximity to the orbit, brain and cranial nerves. Traditional external surgical approaches have potential for significant functional and cosmetic morbidity. An endoscopic approach provides the surgeon with good access for tumour removal and enables surveillance postoperatively. This study aimed to assess outcomes of an endoscopic approach to sinonasal epithelial malignancy and evaluate factors that may influence its utility.

METHODS: A case series was performed involving consecutive patients treated with endoscopic or endoscopic-assisted surgery for epithelial sinonasal malignancy. Stratification included TNM staging, histopathology, surgical approach, margin status, perineural involvement and adjuvant or neoadjuvant therapy. At follow-up, complications, local control, nodal status and evidence of distant metastases were recorded. Statistical analyses to identify risk factors for developing recurrence and survival differences were performed.

RESULTS: Thirty-five patients were assessed in this study (59.2 ± 11.4 years, 42.9% female). T stage at presentation was T1 in 11.4%, T2 in 17.1%, T3 in 22.9% and T4 in 48.6%. The 3 and 5 year disease specific survival were 91.3% (SE 5) and 71.1% (SE 10). The only factors to influence survival outcomes were perineural invasion of tumour and positive margins at the time of initial surgery. Large tumours did not limit the utility of an endoscopic approach.

CONCLUSION: Endoscopic approach is a safe and oncologically equitable treatment approach to external approaches in the management of epithelial sinonasal malignancy. As with external approaches, perineural invasion of malignance is a poor prognostic factor.

PMID:36069324 | DOI:10.1111/ans.18022

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Influencing factors of fatigue among public health nurses during the COVID-19 pandemic: A cross-sectional study

Public Health Nurs. 2022 Sep 7. doi: 10.1111/phn.13131. Online ahead of print.

ABSTRACT

OBJECTIVE: This study investigated the effects of occupational stress, anxiety, depression, and sleep disturbance on the level of fatigue among public health nurses (PHNs).

DESIGN: The study had a cross-sectional, correlational survey design.

MEASURES: A total of 198 PHNs were enrolled from 30 public healthcare centers/offices. Data were collected between May and July 2021 using a structured questionnaire to investigate the general characteristics, occupational stress, anxiety, depression, sleep disturbance, and fatigue of the participants. Descriptive statistics and multiple regressions were used to determine fatigue and its influencing factors among PHNs.

RESULTS: The participants showed high fatigue and occupational stress levels due to a lack of rewards. The percentage of participants with mild-to-severe anxiety and mild-to-severe depression, and those who identified themselves as poor sleepers were 44.9%, 50.5%, and 70.2%, respectively. High levels of sleep disturbance (β = .23, p < .001), occupational stress (β = .21, p < .001), anxiety (β = .20, p = .016), depression (β = .17, p = .043), being younger (β = -.15, p = .004), and being a regular worker (β = .13, p = .017) were influencing factors of fatigue.

CONCLUSIONS: Individual efforts and organizational interventions to enhance sleep quality are needed to relieve fatigue among PHNs. Further, organizational support can be considerate of young nurses and regular workers, and alleviate their occupational stress. Moreover, anxiety and depression should be managed efficiently to reduce fatigue.

PMID:36069312 | DOI:10.1111/phn.13131

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Compromised item detection: A Bayesian change-point perspective

Br J Math Stat Psychol. 2022 Sep 7. doi: 10.1111/bmsp.12286. Online ahead of print.

ABSTRACT

Psychometric methods for accurate and timely detection of item compromise have been a long-standing topic. While Bayesian methods can incorporate prior knowledge or expert inputs as additional information for item compromise detection, they have not been employed in item compromise detection itself. The current study proposes a two-phase Bayesian change-point framework for both stationary and real-time detection of changes in each item’s compromise status. In Phase I, a stationary Bayesian change-point model for compromise detection is fitted to the observed responses over a specified time-frame. The model produces parameter estimates for the change-point of each item from uncompromised to compromised, as well as structural parameters accounting for the post-change response distribution. Using the post-change model identified in Phase I, the Shiryaev procedure for sequential testing is employed in Phase II for real-time monitoring of item compromise. The proposed methods are evaluated in terms of parameter recovery, detection accuracy, and detection efficiency under various simulation conditions and in a real data example. The proposed method also showed superior detection accuracy and efficiency compared to the cumulative sum procedure.

PMID:36069306 | DOI:10.1111/bmsp.12286

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Change in functional status associated with respiratory syncytial virus infection in hospitalized older adults

Influenza Other Respir Viruses. 2022 Sep 7. doi: 10.1111/irv.13043. Online ahead of print.

ABSTRACT

BACKGROUND: Respiratory syncytial virus (RSV) causes severe respiratory illnesses in infants and older adults. Older adults are frequently hospitalized with RSV illness and may experience loss of function. This study evaluated longitudinal changes in function associated with RSV hospitalization in older adults.

METHODS: Adults ≥60 years hospitalized with laboratory-confirmed RSV were enrolled (N = 302). Demographics and comorbidities were collected. Functional status was assessed 2 weeks pre-hospitalization by recall, at enrollment, hospital discharge and 2, 4, and 6 months post-discharge using the Lawton-Brody Instrumental Activities of Daily Living (IADL) (scale 0-8) and Barthel ADL Index (scale 0-100).

RESULTS: RSV-associated hospitalization resulted in acute functional loss. Median IADL (5 vs. 3, p < 0.0001) and ADL (90 vs. 70, p < 0.0001) scores decreased significantly from pre-hospitalization to admission and remained decreased at discharge. There were no statistically significant differences between pre-hospitalization and 2-, 4-, or 6-month scores. However, 33% and 32% of subjects experienced decreased 6-month IADL and ADL scores, respectively. Additionally, 14% required a higher level of care at discharge. When stratified by pre-hospitalization living situation, 6-month IADL scores declined significantly for those admitted from a skilled nursing facility (3 vs. 1, p = 0.001). In multivariate analysis, male sex and diabetes were associated with a 6-month decline in ADL score of ≥10.

CONCLUSIONS: Older adults hospitalized with RSV demonstrate acute functional decline that may become prolonged. Pre-hospitalization living situation may predict patient outcomes. Further study is needed with hospitalized age-matched controls and refined measurement tools to better define the specific impact of RSV on function.

PMID:36069297 | DOI:10.1111/irv.13043