Tag: nevin manimala

Chin Med J (Engl). 2023 Jun 7. doi: 10.1097/CM9.0000000000002639. Online ahead of print.

ABSTRACT

BACKGROUND: The relationship between the elevation of cardiac troponin and the increase of mortality and hospitalization rate in patients with heart failure with reduced ejection fraction is clear. This study investigated the association between the extent of elevated levels of high-sensitivity cardiac troponin I (hs-cTnI) and the prognosis in heart failure with preserved ejection fraction patients.

METHODS: A retrospective cohort study consecutively enrolled 470 patients with heart failure with preserved ejection fraction from September 2014 to August 2017. According to the level of hs-cTnI, the patients were divided into the elevated level group (hs-cTnI >0.034 ng/mL in male and hs-cTnI >0.016 ng/mL in female) and the normal level group. All of the patients were followed up once every 6 months. Adverse cardiovascular events were cardiogenic death and heart failure hospitalization.

RESULTS: The mean follow-up period was 36.2 ± 7.9 months. There was a statistically significant higher in cardiogenic mortality (18.6% [26/140] vs. 1.5% [5/330], P <0.001) and heart failure (HF) hospitalization rate (74.3% [104/140] vs. 43.6% [144/330], P <0.001) in the elevated level group. The Cox regression analysis showed that the elevated level of hs-cTnI was a predictor of cardiogenic death (hazard ratio [HR]: 5.578, 95% confidence interval [CI]: 2.995-10.386, P <0.001) and HF hospitalization (HR: 3.254, 95% CI: 2.698-3.923, P <0.001). The receiver operating characteristic curve demonstrated that a sensitivity of 72.6% and specificity of 88.8% for correct prediction of adverse cardiovascular events when a level of hs-cTnI of 0.1305 ng/mL in male and a sensitivity of 70.6% and specificity of 90.2% when a level of hs-cTnI of 0.0755 ng/mL in female were used as the cut-off value.

CONCLUSION: Significant elevation of hs-cTnI (≥0.1305 ng/mL in male and ≥0.0755 ng/mL in female) is an effective indicator of the increased risk of cardiogenic death and HF hospitalization in heart failure with preserved ejection fraction patients.

PMID:37279378 | DOI:10.1097/CM9.0000000000002639

Discov Oncol. 2023 Jun 6;14(1):90. doi: 10.1007/s12672-023-00678-3.

ABSTRACT

PURPOSE: Glioblastoma (GBM) has a poor prognosis after standard treatment. Recently, metformin has been shown to have an antitumor effect on glioma cells. We performed the first randomized prospective phase II clinical trial to investigate the clinical efficacy and safety of metformin in patients with recurrent or refractory GBM treated with low-dose temozolomide.

METHODS: Included patients were randomly assigned to a control group [placebo plus low-dose temozolomide (50 mg/m², daily)] or an experimental group [metformin (1000 mg, 1500 mg, and 2000 mg per day during the 1st, 2nd, and 3rd week until disease progression, respectively) plus low-dose temozolomide]. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), disease control rate, overall response rate, health-related quality of life, and safety.

RESULTS: Among the 92 patients screened, 81 were randomly assigned to the control group (43 patients) or the experimental group (38 patients). Although the control group showed a longer median PFS, the difference between the two groups was not statistically significant (2.66 versus 2.3 months, p = 0.679). The median OS was 17.22 months (95% CI 12.19-21.68 months) in the experimental group and 7.69 months (95% CI 5.16-22.67 months) in the control group, showing no significant difference by the log-rank test (HR: 0.78; 95% CI 0.39-1.58; p = 0.473). The overall response rate and disease control rate were 9.3% and 46.5% in the control group and 5.3% and 47.4% in the experimental group, respectively.

CONCLUSIONS: Although the metformin plus temozolomide regimen was well tolerated, it did not confer a clinical benefit in patients with recurrent or refractory GBM. Trial registration NCT03243851, registered August 4, 2017.

PMID:37278858 | DOI:10.1007/s12672-023-00678-3

Wien Klin Wochenschr. 2023 Jun 6. doi: 10.1007/s00508-023-02222-3. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of the present study was to determine the demographic, epidemiological and clinical characteristics of adult patients with tetanus in Slovenia between 2006 and 2021, as well as to determine the therapeutic approaches which have been successfully used in the intensive care unit (ICU) of the Infectious Diseases Department in the University Medical Centre Ljubljana (UMC).

METHODS: We included all adult patients who were treated for tetanus in the ICU of the Department of Infectious Diseases Ljubljana between January 1st, 2006, and December 31th, 2021, in the retrospective study. Available epidemiological and clinical characteristics were reviewed from the medical documentation.

RESULTS: There were 31 patients included in the study, four (12.9%) males and 27 (87.1%) females. The vast majority of patients required mechanical ventilation (MV) (87.1%) which lasted (± SD) on average 35.4 ± 16.0 days. Autonomic dysfunction was present in 29 (93.5%) patients and was statistically significantly associated with shorter disease evolution (p = 0.005) and presence of healthcare-associated infection (p = 0.020). During the hospitalization, 27 (87.1%) patients acquired at least one healthcare-associated infection, most commonly ventilator-associated pneumonia. The average length of stay in the ICU (± SD) was 42.5 ± 21.3 days. With increasing age, MV lasted statistically significantly longer (p = 0.001), length of stay was longer (p = 0.015), and healthcare-associated infections occurred (p = 0.003) more frequently. Four patients (12.9%) died.

CONCLUSIONS: Although the tetanus incidence rate in Slovenia is high in comparison to other European countries on average, our therapeutic approach resulted in a good survival rate and low mortality.

PMID:37278856 | DOI:10.1007/s00508-023-02222-3

Eur Radiol. 2023 Jun 6. doi: 10.1007/s00330-023-09805-8. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the utility of ultrafast dynamic-contrast-enhanced (DCE) MRI in visualization and quantitative characterization of pregnancy-associated breast cancer (PABC) and its differentiation from background-parenchymal-enhancement (BPE) among lactating patients.

MATERIALS AND METHODS: Twenty-nine lactating participants, including 10 PABC patients and 19 healthy controls, were scanned on 3-T MRI using a conventional DCE protocol interleaved with a golden-angle radial sparse parallel (GRASP) ultrafast sequence for the initial phase. The timing of the visualization of PABC lesions was compared to lactational BPE. Contrast-noise ratio (CNR) was compared between the ultrafast and conventional DCE sequences. The differences in each group’s ultrafast-derived kinetic parameters including maximal slope (MS), time to enhancement (TTE), and area under the curve (AUC) were statistically examined using the Mann-Whitney test and receiver operator characteristic (ROC) curve analysis.

RESULTS: On ultrafast MRI, breast cancer lesions enhanced earlier than BPE (p < 0.0001), enabling breast cancer visualization freed from lactation BPE. A higher CNR was found for ultrafast acquisitions vs. conventional DCE (p < 0.05). Significant differences in AUC, MS, and TTE values were found between the tumor and BPE (p < 0.05), with ROC-derived AUC of 0.86 ± 0.06, 0.82 ± 0.07, and 0.68 ± 0.08, respectively. The BPE grades of the lactating PABC patients were reduced as compared with the healthy lactating controls (p < 0.005).

CONCLUSION: Ultrafast DCE MRI allows BPE-free visualization of lesions, improved tumor conspicuity, and kinetic quantification of breast cancer during lactation. Implementation of this method may assist in the utilization of breast MRI for lactating patients.

CLINICAL RELEVANCE: The ultrafast sequence appears to be superior to conventional DCE MRI in the challenging evaluation of the lactating breast. Thus, supporting its possible utilization in the setting of high-risk screening during lactation and the diagnostic workup of PABC.

KEY POINTS: • Differences in the enhancement slope of cancer relative to BPE allowed the optimal visualization of PABC lesions on mid-acquisitions of ultrafast DCE, in which the tumor enhanced prior to the background parenchyma. • The conspicuity of PABC lesions on top of the lactation-related BPE was increased using an ultrafast sequence as compared with conventional DCE MRI. • Ultrafast-derived maps provided further characterization and parametric contrast between PABC lesions and lactation-related BPE.

PMID:37278853 | DOI:10.1007/s00330-023-09805-8

Matern Child Health J. 2023 Jun 6. doi: 10.1007/s10995-023-03727-z. Online ahead of print.

ABSTRACT

INTRODUCTION: Home visitor well-being is integral to delivering effective home visiting services and a core component of successful home visiting program implementation. While burnout (BO), compassion fatigue (CF), and compassion satisfaction (CS) have been studied extensively in physicians, nurses, and other health providers, little is known about the correlates of these phenomena in home visitors.

METHODS: This cross-sectional study examined demographic characteristics (age, race, gender), health and personal experiences (anxiety, physical health, and adverse childhood experiences), and job-related factors (caseload, role certainty, job satisfaction) as correlates of BO, CF and CS among a sample of 75 home visitors employed across six MIECHV-funded agencies in New York State. Descriptive statistics were used to characterize our sample; linear regressions were employed to investigate correlates with outcomes of interest.

RESULTS: Anxiety was significantly and positively associated with BO (β = 2.5, p < 0.01) and CF (β = 3.08, p < 0.01). Overall job satisfaction was significantly and inversely associated with BO only (β = -0.11, p < 0.001). Participants who identified as white were less likely to report higher levels of CS relative to non-white counterparts (β = -4.65, p = 0.014). Examinations of specific aspects of job satisfaction revealed significant associations between satisfaction with workplace operating conditions, nature of the work, and contingent rewards and select outcomes of interest.

DISCUSSION: Prioritizing preventive measures that target correlates of BO and CF, such as higher levels of anxiety and lower levels of job satisfaction – particularly operating conditions – may improve workforce well-being, continuity of service delivery, and ultimately quality of care provided to clients.

PMID:37278846 | DOI:10.1007/s10995-023-03727-z

Int J Comput Assist Radiol Surg. 2023 Jun 6. doi: 10.1007/s11548-023-02963-6. Online ahead of print.

ABSTRACT

PURPOSE: This work uses deep learning algorithms to provide automated feedback on the suture with intracorporeal knot exercise in the fundamentals of laparoscopic surgery simulator. Different metrics were designed to provide informative feedback to the user on how to complete the task more efficiently. The automation of the feedback will allow students to practice at any time without the supervision of experts.

METHODS: Five residents and five senior surgeons participated in the study. Object detection, image classification, and semantic segmentation deep learning algorithms were used to collect statistics on the practitioner’s performance. Three task-specific metrics were defined. The metrics refer to the way the practitioner holds the needle before the insertion to the Penrose drain, and the amount of movement of the Penrose drain during the needle’s insertion.

RESULTS: Good agreement between the human labeling and the different algorithms’ performance and metric values was achieved. The difference between the scores of the senior surgeons and the surgical residents was statistically significant for one of the metrics.

CONCLUSION: We developed a system that provides performance metrics of the intracorporeal suture exercise. These metrics can help surgical residents practice independently and receive informative feedback on how they entered the needle into the Penrose.

PMID:37278834 | DOI:10.1007/s11548-023-02963-6

Z Rheumatol. 2023 Jun 6. doi: 10.1007/s00393-023-01374-x. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to assess the relative efficacy and safety of calcineurin inhibitor (CNI), mycophenolate mofetil (MMF), and azathioprine (AZA) as maintenance therapies for lupus nephritis.

METHODS: Randomized controlled trials (RCTs) examining the efficacy and safety of CNI, MMF, and AZA as maintenance therapies in patients with lupus nephritis were included. We performed a Bayesian random-effects network meta-analysis to combine the direct and indirect evidence from RCTs.

RESULTS: Ten RCTs comprising 884 patients were included in the study. Although the difference was not statistically significant, MMF showed a trend toward a lower relapse rate compared with AZA (odds ratio [OR] 0.72, 95% credible interval [CrI] 0.45-1.22). Similarly, tacrolimus showed a trend toward a lower relapse rate compared with AZA (OR 0.85, 95% CrI 0.34-2.00). Ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that MMF had the highest probability of being the best treatment based on the relapse rate, followed by CNI and AZA. The incidence of leukopenia in the MMF and CNI groups was significantly lower than that in the AZA group (OR 0.12, 95% CrI 0.04-0.34; OR 0.16, 95% CrI 0.04-0.50; respectively). Fewer patients with infections were observed in the MMF group than in the AZA group, although the difference was not statistically significant. The analysis of withdrawals due to adverse events showed a similar pattern.

CONCLUSION: Lower relapse rates combined with a more favorable safety profile suggest that CNI and MMF are superior to AZA as maintenance treatments in lupus nephritis patients.

PMID:37278824 | DOI:10.1007/s00393-023-01374-x

Eur J Clin Pharmacol. 2023 Jun 6. doi: 10.1007/s00228-023-03517-0. Online ahead of print.

ABSTRACT

BACKGROUND: The ongoing pandemic of severe acute respiratory syndrome coronavirus 2 has led to an enormous surge of clinical research. So far, the speed and success rate of related drug development projects, especially of vaccines, is unprecedented. For the first time, this situation allowed for the opportunistic evaluation of a translatability score, originally proposed in 2009, in a prospective manner.

METHODS: Several vaccines and treatments under development in clinical phase III trials were selected for translational scoring with the translatability score. Six prospective and six retrospective case studies were performed. The scores had to be determined for a fictive date before any results of the phase III trial were reported in any media. Spearman correlation analysis and a Kruskal Wallis test were performed for statistical evaluation.

RESULTS: A significant correlation between the translatability scores and the clinical outcomes in translation was found, as judged on the basis of positive/intermediate/negative endpoint studies or market approval. The Spearman correlation analysis of all cases (r = 0.91, p < 0.001), the prospective cases alone (r = 0.93, p = 0.008), and the retrospective cases alone (r = 0.93, p = 0.008) showed a strong correlation between the score and outcome; R² demonstrated a score-derived determination of outcomes by 86%.

CONCLUSIONS: The score detects strengths and weaknesses of a given project, resulting in the opportunity of selective amelioration of a project, as well as prospective portfolio risk balancing. Its substantial predictive value that has been demonstrated here for the first time could be of particular interest for biomedical industry (pharmaceutical and device manufacturers), funding agencies, venture capitalists, and researchers in the area. Future evaluations will have to address the generalizability of results obtained in an exceptional pandemic situation, and the potential adaptations of weighing factors/items to particular therapeutic areas.

PMID:37278822 | DOI:10.1007/s00228-023-03517-0

J Robot Surg. 2023 Jun 6. doi: 10.1007/s11701-023-01638-3. Online ahead of print.

ABSTRACT

We compared the surgical outcomes of robot-assisted laparoscopic hysterectomy (RAH) and total laparoscopic hysterectomy (TLH). This single-center cohort study compared 139 RAH cases from January, 2017 to September, 2021 and 291 TLH cases between January, 2015 and December, 2020. We retrospectively evaluated surgical outcomes, including total operative time (defined as the time from port wound incision to port wound closure), net operative time (defined as the time from the start of pneumoperitoneum to the end of pneumoperitoneum), estimated blood loss, weight of excised uterus (±adnexa), and overall complications, and the relationship between surgeon experience and operative time, net operative time, and blood loss in RAH and TLH. There was no significant difference in the total operative time between the two groups. Regardless of surgeon experience, the net operative time was significantly shorter in the RAH group than in the TLH group (p <0.001) and the estimated blood loss was significantly lower in RAH cases than in TLH cases (p = 0.01). The net operative time per uterine weight was shorter in the TLH group than that in the RAH group; however, there was no significant difference. RAH resulted in statistically better surgical outcomes in terms of net operative time and blood loss, regardless of surgeon experience. However, net operative time and blood loss also seem to be significantly affected by uterus weight. Large trials are imperative to determine the more effective surgical approach between RAH and TLH for different patient subsets.

PMID:37278809 | DOI:10.1007/s11701-023-01638-3

Palliat Support Care. 2023 Jun 6:1-5. doi: 10.1017/S1478951523000512. Online ahead of print.

ABSTRACT

OBJECTIVES: Given the many statistical analysis options used for randomized controlled trials (RCTs) of behavioral interventions and the lack of clear guidance for analysis selection, the present study aimed to characterize the predominate statistical analyses utilized in RCTs in palliative care and behavioral research and to highlight the relative strengths and weaknesses of each of these methods as guidance for future researchers and reform.

METHODS: All RCTs published between 2015 and 2021 were systematically extracted from 4 behavioral medicine journals and analyzed based on prespecified inclusion criteria. Two independent raters classified each of the manuscripts into 1 of 5 RCT analysis strategies.

RESULTS: There was wide variation in the methods used. The 2 most prevalent analyses for RCTs were longitudinal modeling and analysis of covariance. Application of method varied significantly by sample size.

SIGNIFICANCE OF RESULTS: Each statistical analysis presents its own unique strengths and weaknesses. The information resulting from this research may prove helpful for researchers in palliative care and behavioral medicine in navigating the variety of statistical methods available. Future discussion around best practices in RCT analyses is warranted to compare the relative impact of interventions in a more standardized way.

PMID:37278213 | DOI:10.1017/S1478951523000512