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Nevin Manimala Statistics

Prognostic value of non-resistant and resistant masked uncontrolled hypertension detected by ambulatory blood pressure monitoring

J Clin Hypertens (Greenwich). 2022 Mar 17. doi: 10.1111/jch.14460. Online ahead of print.

ABSTRACT

Masked uncontrolled hypertension (MUCH) is at higher cardiovascular risk than controlled hypertension (CH). In previous studies, patients with MUCH were considered as a unique group though those receiving ≤2 drugs could be defined as having nonresistant MUCH (NRMUCH) and those receiving ≥3 drugs as having resistant MUCH (RMUCH). The aim of this study was to assess the prognostic value of NRMUCH and RMUCH detected by ambulatory blood pressure (BP) monitoring. Cardiovascular risk was evaluated in 738 treated hypertensive patients with normal clinic BP. Patients were classified as having CH or MUCH if daytime BP < or ≥ 135/85 mmHg, respectively, regardless of nighttime BP, or CH or MUCH if 24-h BP < or ≥ 130/80 mmHg, respectively, regardless of daytime or nighttime BP. By daytime or 24-h BP, the authors detected 523 (71%), 178 (24%), and 37 (5%) or 463 (63%), 231 (31%), and 44 (6%) patients with CH, NRMUCH, and RMUCH, respectively. During the follow-up (median 10 years), 148 events occurred. After adjustment for covariates, compared to CH, the hazard ratio (HR), 95% confidence interval (CI), for cardiovascular events was 1.81, 1.27-2.57, and 2.99, 1.73-5.16, in NRMUCH and RMUCH defined by daytime BP, respectively, and 1.58, 1.12-2.23, and 2.21, 1.27-3.82, in NRMUCH and RMUCH defined by 24-h BP, respectively. If RMUCH was compared with NRMUCH, the risk tended to be higher in RMUCH but did not attain statistical significance (P = .08 and P = .23 by daytime and 24-h BP thresholds, respectively). In conclusion, both NRMUCH and RMUCH are at increased cardiovascular risk than CH.

PMID:35301793 | DOI:10.1111/jch.14460

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The association between skeletal muscle measures and chemotherapy-induced toxicity in non-small cell lung cancer patients

J Cachexia Sarcopenia Muscle. 2022 Mar 18. doi: 10.1002/jcsm.12967. Online ahead of print.

ABSTRACT

BACKGROUND: Chemotherapy-induced toxicities frequently occur in non-small cell lung cancer (NSCLC) patients treated with platinum-based chemotherapy. Low skeletal muscle mass (SMM) has been associated with a higher incidence of toxicities for several types of cancers and cytostatics. The aim of this study was to evaluate the association between skeletal muscle measures and chemotherapy-induced toxicity in a large cohort of NSCLC patients.

METHODS: A multicentre prospective follow-up study (PGxLUNG, NTR number NL5373610015) in NSCLC patients was conducted. Included were patients diagnosed with NSCLC (stage II-IV) treated with first-line platinum-based (cisplatin or carboplatin) chemotherapy of whom pretreatment imaging was available. Skeletal muscle area (SMA) segmentation was performed on abdominal imaging at the level of the third lumbar vertebra (L3). SMA at the level of L3 was corrected for squared height (m2 ) to yield the lumbar skeletal muscle mass index (LSMI). Skeletal muscle density (SMD) was calculated as the mean Hounsfield Unit (HU) of the segmented SMA. SMM and SMD were categorized as low, intermediate, and high, based on LSMI and mean HU tertiles, respectively. Chemotherapy-induced toxicity was scored using CTCAE v4.03 and categorized into haematological (anaemia, leukocytopenia, neutropenia, and thrombocytopenia), non-haematological (nephrotoxicity, neurotoxicity, and esophagitis), and dose-limiting toxicity (DLT) (treatment switch, delay, de-escalation, discontinuation, or hospitalization). The relationship between SMM, SMD, and toxicities was assessed with logistic regression modelling taking into account potential confounders like gender and body mass index (BMI).

RESULTS: In total, 297 patients (male n = 167, median age 64 years) were included. Haematological toxicity grade 3/4 was experienced in 36.6% (n = 108) of the patients, 24.6% (n = 73) experienced any non-haematological toxicity grade ≥2, and 55.6% (n = 165) any DLT. Multivariate logistic regression analysis showed that low SMM (ORadj 2.41, 95% CI 1.31-4.45, P = 0.005) and age at diagnosis >65 years (ORadj 1.76, 95% CI 1.07-2.90, P = 0.025) were statistically significantly associated with overall haematological toxicity grade 3/4. No statistically significant associations were found between low SMM or low SMD and non-haematological toxicities. Low SMM (ORadj 2.23, 95% CI 1.23-4.04, P = 0.008) and high SMD (ORadj 0.41, 95% CI 0.23-0.74, P = 0.003) were statistically significantly associated with a higher respectively lower risk of DLT.

CONCLUSIONS: Non-small cell lung cancer patients with pretreatment low SMM are at significant higher risk for haematological toxicities grade 3/4 and DLT. NSCLC patients with high SMD are at significant lower risk for DLT. Further studies should be aimed to investigate whether platinum dosing based on skeletal muscle measurements and/or improvement of pretreatment SMM/SMD could reduce the risk of toxicity without compromising efficacy.

PMID:35301821 | DOI:10.1002/jcsm.12967

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Nevin Manimala Statistics

Improving patient well-being in the United States through care coordination interventions informed by social determinants of health

Health Soc Care Community. 2022 Mar 17. doi: 10.1111/hsc.13776. Online ahead of print.

ABSTRACT

Health and well-being are promoted when primary care teams partner with patients and provide care coordination to mitigate risks and promote optimal health. Identification of patients for care coordination is typically based on claim-driven risk assessments. Evidence shows that social determinants of health (SDOH) drive risk for adverse health outcomes but are omitted from existing risk tools. Missed opportunities for care coordination contribute to increased healthcare costs, poorer health outcomes and reduced patient well-being. To address the gap of risk-informed care coordination that includes SDOH, the aim of this project was to implement process improvement of a system’s care coordination program through refined patient selection and customised engagement in intensive care coordination. A non-randomised care coordination quality improvement project was conducted at a community health centre in 2020. Inclusion criteria (i.e. presence of risk attribution score, SDOH questionnaire completed) resulted in 540 patients being offered care coordination services; Patients having at least one month of care coordination were included in the analysis (N = 216). Analysis included the 216 patients that chose participation and the 324 patients that maintained usual care. Descriptive statistics were generated to distinguish patient demographics, frequency of care coordination contact, and specific SDOH insecurities for both the study and comparison groups. Paired t-tests were incorporated to evaluate statistical significance of the intervention group. Impact on well-being, SDOH barriers, appointment adherence and health outcomes were assessed in both conditions. Intervention condition patients reported improvement in well-being [feeling anxious (t = 4.051; p < 0.000)] and reduced SDOH barriers [food access (t = 4.662; p < 0.000); housing (t = 2.203; p = 0.008)] that were significantly different from the usual care condition in the expected directions. Care coordination based on factors including SDOH risks shows promise in improving patient well-being. Future research should refine this approach for comprehensive risk assessment to intervene and support patient health and well-being.

PMID:35301764 | DOI:10.1111/hsc.13776

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Nevin Manimala Statistics

The impact of transformational leadership on nurse faculty satisfaction and burnout during the COVID-19 pandemic: A moderated mediated analysis

J Adv Nurs. 2022 Mar 17. doi: 10.1111/jan.15198. Online ahead of print.

ABSTRACT

AIMS: To examine the effects of nursing deans/directors’ transformational leadership behaviours on academic workplace culture, faculty burnout and job satisfaction.

BACKGROUND: Transformational leadership is an imperative antecedent to organizational change, and employee well-being and performance. However, little has been espoused regarding the theoretical and empirical mechanisms by which transformational leaders improve the academic workplace culture and faculty retention.

DESIGN: A cross-sectional survey design was implemented.

METHODS: Nursing faculty employed in Canadian academic settings were invited to complete an anonymous online survey in May-July 2021. A total of 645 useable surveys were included in the analyses. Descriptive statistics and reliability estimates were performed. The moderated mediation model was tested using structural equation modelling in the Analysis of Moment software v24.0. Bootstrap method was used to estimate total, direct and indirect effects.

RESULT: The proposed study model was supported. Transformational leadership had both a strong direct effect on workplace culture and job satisfaction and an inverse direct effect on faculty burnout. While workplace culture mediated the effect of leadership on job satisfaction and burnout, the moderation effect of COVID-19 was not captured in the baseline model.

CONCLUSION: The findings provide an in-depth understanding of the factors that affect nursing faculty wellness, and evidence that supportive workplace culture can serve as an adaptive mechanism through which transformational leaders can improve retention. A transformational dean/director can proactively shape the nature of the academic work environment to mitigate the risks of burnout and improve satisfaction and ultimately faculty retention even during an unforeseen event, such as a pandemic.

IMPLICATION: Given the range of uncertainties associated with COVID-19, administrators should consider practicing transformational leadership behaviours as it is most likely to be effective, especially in times of uncertainty and chaos. In doing so, academic leaders can work towards equitable policies, plans and decisions and rebuild resources to address the immediate and long-term psychological and overall health impacts of COVID-19.

PMID:35301738 | DOI:10.1111/jan.15198

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Effect of mild or moderate hepatic impairment on the pharmacokinetics of risdiplam

Br J Clin Pharmacol. 2022 Mar 17. doi: 10.1111/bcp.15319. Online ahead of print.

ABSTRACT

AIM: This Phase I, multicentre, open-label, non-randomised, parallel-group, two-part study aimed to evaluate the effect of mild to moderate hepatic impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of risdiplam.

METHODS: Adult subjects (aged 18-70 years) with mild (Child-Pugh Class A; Part 1) or moderate (Child-Pugh Class B; Part 2) hepatic impairment were matched with subjects with normal hepatic function on sex, age, body mass index and smoking status. Each subject received a single oral dose of 5 mg risdiplam. Plasma concentrations of risdiplam and its metabolite M1 were measured, and PK parameters were compared. Adverse events, laboratory abnormalities, vital signs and electrocardiogram measurements were assessed.

RESULTS: After a single dose (5 mg) risdiplam, the risdiplam PK parameters area under the plasma concentration-time curve from time zero to infinity and maximum observed plasma concentration were approximately 20% and 5% lower, respectively, in subjects with mild hepatic impairment and approximately 8% and 20% higher, respectively, in subjects with moderate hepatic impairment compared with subjects with normal hepatic function. These differences were not statistically significant; all 90% confidence intervals for geometric least squares-means ratios spanned unity. No new risdiplam-related safety findings were observed in subjects with mild or moderate hepatic impairment.

CONCLUSION: Mild or moderate hepatic impairment did not have a clinically relevant impact on the PK of risdiplam. Therefore, no dose adjustment is required in patients with mild or moderate hepatic impairment when receiving risdiplam.

PMID:35301746 | DOI:10.1111/bcp.15319

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Exposure to Recurring Community Violence Scale: A validity and reliability study in Turkey

J Community Psychol. 2022 Mar 18. doi: 10.1002/jcop.22841. Online ahead of print.

ABSTRACT

Recent years have witnessed a substantial increase in the interest in violence occurring at home or school, as well as in neighborhoods. Yet, there is no standardized instrument to measure community violence in Turkey. Thus, the present study aimed to adapt the Exposure to Recurring Community Violence Scale into Turkish and explore its psychometric properties. The sample consisted of 210 participants (57% were females) between 18 and 64 years (Mage = 38.33, SD = 10.67). For criterion-related validity, we evaluated the participants’ scores on the Brief Symptom Inventory (BSI), the Traumatic Life Events Form, the Relationship Quality Scale, and a Demographic Information Form. We performed all statistical analyses using the FACTOR and SPSS v.20 programs. Exploratory factor analysis revealed a 2-factor structure for the scale (victimization and witnessing), explaining 52% of the total variance. As expected, the witnessing and victimization scores were correlated with the subscales of the BSI, the number of traumatic life events, and the subscales of The Relationship Quality Scale. For reliability concerns, we calculated Cronbach’s α coefficients to be 0.79 for the victimization and 0.90 for the witnessing. Besides, the findings revealed acceptable psychometric properties for the Turkish version of the Exposure to Recurring Community Violence Scale. Thereby, we concluded that the scale can be used as a reliable and valid measure in the Turkish context. Overall, the scale will likely allow further research to scrutinize the risk factors and consequences of community violence.

PMID:35301721 | DOI:10.1002/jcop.22841

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Checkpoint CD47 expression in classical Hodgkin lymphoma

Br J Haematol. 2022 Mar 17. doi: 10.1111/bjh.18137. Online ahead of print.

ABSTRACT

The glycoprotein CD47 regulates antiphagocytic activity via signal regulatory protein alpha (SIRPa). This study investigated CD47 expression on Hodgkin and Reed-Sternberg (HRS) cells in the classical Hodgkin lymphoma (cHL) tumour microenvironment and its correlation with prognosis, programmed-death (PD) immune markers, and SIRPa+ leukocytes. We conducted immunohistochemistry with CD47 and SIRPa antibodies on diagnostic biopsies (tissue microarrays) from cHL patients from two cohorts (n = 178). In cohort I (n = 136) patients with high expression of CD47 on HRS cells (n = 48) had a significantly inferior event-free survival [hazard ratio (HR) = 5.57; 95% confidence interval (CI), 2.78-11.20; p < 0.001] and overall survival (OS) (HR = 8.54; 95% CI, 3.19-22.90; p < 0.001) compared with patients with low expression (n = 88). The survival results remained statistically significant in multivariable Cox regression adjusted for known prognostic factors. In cohort II (n = 42) high HRS cell CD47 expression also carried shorter event-free survival (EFS) (HR = 5.96; 95% CI, 1.20-29.59; p = 0.029) and OS (HR = 5.61; 95% CI, 0.58-54.15; p = 0.136), although it did not retain statistical significance in the multivariable analysis. Further, high CD47 expression did not correlate with SIRPa+ leukocytes or PD-1, PD-L1 and PD-L2 expression. This study provides a deeper understanding of the role of CD47 in cHL during an era of emerging CD47 therapies.

PMID:35301709 | DOI:10.1111/bjh.18137

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Nevin Manimala Statistics

Convolutional Neural Network-aided Tuber Segmentation in Tuberous Sclerosis Complex Patients Correlates with EEG

Epilepsia. 2022 Mar 17. doi: 10.1111/epi.17227. Online ahead of print.

ABSTRACT

OBJECTIVE: One of the clinical hallmarks of tuberous sclerosis complex is radiologically-identified cortical tubers present in most patients. Intractable epilepsy may require surgery, often involving invasive diagnostic procedures such as intracranial EEG. Identifying the location of the dominant tuber responsible for generating epileptic activities, is a critical issue. However, the link between cortical tubers and epileptogenesis is poorly understood. Given this, we hypothesized that tuber voxel intensity may be an indicator of the dominant epileptogenic tuber. Also, via tuber segmentation based on deep learning, we explore whether an automatic quantification of the tuber burden is feasible.

METHODS: We annotated tubers from structural MRIs across 29 TSC subjects, summarized tuber statistics in eight brain lobes, and determined suspected epileptogenic lobes from the same group using EEG monitoring data. Then logistic regression analyses are performed to demonstrate the linkage between the statistics of cortical tuber and the epileptogenic zones. Furthermore, we test the ability of a neural network to identify and quantify tuber burden.

RESULTS: Logistic regression analyses show that the volume and count of tubers per lobe, not the mean or variance of tuber voxel intensity, are positively correlated with electrophysiological data. In 47.6% of subjects, the lobe with the largest tuber volume concurred with the epileptic brain activity. A neural network model on the test dataset shows a sensitivity of 0.83 for localizing individual tubers. The predicted masks from the model highly correlated with the neurologist labels, thus may be a useful tool for determining tuber burden and searching for epileptogenic zone.

SIGNIFICANCE: we prove the feasibility of an automatic segmentation of tubers and a derivation of tuber burden across brain lobes. Our method may provide crucial insights in the treatment and outcome of TSC patients.

PMID:35301716 | DOI:10.1111/epi.17227

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Nomogram for predicting the 12-year risk of ADL disability among older adults

Aging Clin Exp Res. 2022 Mar 17. doi: 10.1007/s40520-022-02105-z. Online ahead of print.

ABSTRACT

OBJECTIVES: Previous studies have identified plenty of risk factors for activities of daily living (ADL). However, there are no reliable and widely available prediction models for ADL disability up to now. This study aimed to develop and validate a nomogram for predicting the 12-year risk of ADL disability in older adults.

METHODS: Data from 4,809 participants in the English Longitudinal Study of Ageing (ELSA) and 18,620 participants in the Survey of Health, Ageing and Retirement in Europe (SHARE) were used as training set and validation set, respectively. We used the least absolute shrinkage and selection operator (LASSO) and Cox regression to screen the predictors and develop the nomogram. The P value, concordance index (C-index), integrated area under the ROC (receiver operating characteristic) curve (AUC) and calibration curves were used to validate the nomogram.

RESULTS: During 12 years, 30.0% (n = 1,441) participants developed ADL disability in the training set, while the corresponding percentages were 18.5% in the validation set (n = 3,445). After screening, 13 variables were contained in the final prediction model. In ADL nomogram, the C-index and AUC were 0.744 ± 0.013 and 0.793 in internal valid ation, respectively, while in external validation, the C-index and AUC were 0.755 ± 0.009 and 0.796.

CONCLUSIONS: This study developed and validated a nomogram that predicts functional disability. The application of the predictive model could have important implications for patient prognosis and health care.

PMID:35301701 | DOI:10.1007/s40520-022-02105-z

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Application of Shear Wave Elastography and Contrast-Enhanced Ultrasound in Transrectal Prostate Biopsy

Curr Med Sci. 2022 Mar 17. doi: 10.1007/s11596-022-2484-1. Online ahead of print.

ABSTRACT

OBJECTIVE: To explore the clinical value of ultrasound shear wave elastography (SWE) and contrast-enhanced ultrasound (CEUS) in transrectal prostate biopsy.

METHODS: A total of 54 patients (average age: 67.79±12.01 years) in the experimental group underwent transrectal prostate biopsy under the guidance of SWE, while 46 patients (average age: 69.22±11.54 years) in the control group underwent transrectal prostate biopsy guided by CEUS.

RESULTS: There were a total of 451 needles, with an average of 8.35±1.67 needles per patient in the experimental group, and a total of 462 needles, with an average of 10.04±1.33 needles per patient in the control group. The difference in puncture times between the two groups was statistically significant (P<0.05). There was no significant difference in the positive detection rate, sensitivity or specificity between the two groups (P>0.05), but there was a significant difference in the diagnostic accuracy between the two groups (P<0.05). The Emean and Emax of prostate cancer were significantly higher in the experimental group than in benign prostatic hyperplasia (P<0.05). The receiver operating characteristic curve (ROC) analysis showed that the area under the ROC curve (AUC) of Emean was 0.752 (S.E. =0.072, 95% CI=0.611-0.894, P=0.007), and the best cutoff value was 47.005 kPa.

CONCLUSION: In summary, both SWE- and CEUS-guided transrectal prostate biopsy can help find the focus and guide the puncture, and improve the positive detection rate.

PMID:35301673 | DOI:10.1007/s11596-022-2484-1