Categories
Nevin Manimala Statistics

COVID-19 pandemic, mechanical reperfusion and 30-day mortality in ST elevation myocardial infarction

Heart. 2021 Oct 28:heartjnl-2021-319750. doi: 10.1136/heartjnl-2021-319750. Online ahead of print.

ABSTRACT

OBJECTIVE: The initial data of the International Study on Acute Coronary Syndromes – ST Elevation Myocardial Infarction COVID-19 showed in Europe a remarkable reduction in primary percutaneous coronary intervention procedures and higher in-hospital mortality during the initial phase of the pandemic as compared with the prepandemic period. The aim of the current study was to provide the final results of the registry, subsequently extended outside Europe with a larger inclusion period (up to June 2020) and longer follow-up (up to 30 days).

METHODS: This is a retrospective multicentre registry in 109 high-volume primary percutaneous coronary intervention (PPCI) centres from Europe, Latin America, South-East Asia and North Africa, enrolling 16 674 patients with ST segment elevation myocardial infarction (STEMI) undergoing PPPCI in March/June 2019 and 2020. The main study outcomes were the incidence of PPCI, delayed treatment (ischaemia time >12 hours and door-to-balloon >30 min), in-hospital and 30-day mortality.

RESULTS: In 2020, during the pandemic, there was a significant reduction in PPCI as compared with 2019 (incidence rate ratio 0.843, 95% CI 0.825 to 0.861, p<0.0001). This reduction was significantly associated with age, being higher in older adults (>75 years) (p=0.015), and was not related to the peak of cases or deaths due to COVID-19. The heterogeneity among centres was high (p<0.001). Furthermore, the pandemic was associated with a significant increase in door-to-balloon time (40 (25-70) min vs 40 (25-64) min, p=0.01) and total ischaemia time (225 (135-410) min vs 196 (120-355) min, p<0.001), which may have contributed to the higher in-hospital (6.5% vs 5.3%, p<0.001) and 30-day (8% vs 6.5%, p=0.001) mortality observed during the pandemic.

CONCLUSION: Percutaneous revascularisation for STEMI was significantly affected by the COVID-19 pandemic, with a 16% reduction in PPCI procedures, especially among older patients (about 20%), and longer delays to treatment, which may have contributed to the increased in-hospital and 30-day mortality during the pandemic.

TRIAL REGISTRATION NUMBER: NCT04412655.

PMID:34711661 | DOI:10.1136/heartjnl-2021-319750

Categories
Nevin Manimala Statistics

Risk of Incident Dementia According to Glycemic Status and Comorbidities of Hyperglycemia: A Nationwide Population-Based Cohort Study

Diabetes Care. 2021 Oct 28:dc210957. doi: 10.2337/dc21-0957. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the risk of incident dementia according to fasting glucose levels and presence of comorbidities.

RESEARCH DESIGN AND METHODS: Using a health insurance claims database and the results of biennial health examinations in South Korea, we selected 8,400,950 subjects aged ≥40 years who underwent health examinations in 2009-2010. We followed them until 2016. Subjects’ baseline characteristics were categorized by presence of diabetes (yes/no) and glycemic status as normoglycemia, impaired fasting glucose (IFG), new-onset diabetes, or known diabetes (duration <5 years or ≥5 years). We estimated adjusted hazard ratios (aHRs) for dementia occurrence in each category.

RESULTS: During the observation period of 48,323,729 person-years, all-cause dementia developed in 353,392 subjects (4.2%). Compared with normoglycemia, aHRs (95% CI) were 1.01 (1.01-1.02) in IFG, 1.45 (1.44-1.47) in new-onset diabetes, 1.32 (1.30-1.33) in known diabetes <5 years, and 1.62 (1.60-1.64) in known diabetes ≥5 years. We found that associations between ischemic heart disease and chronic kidney disease with incident dementia were affected by the presence of diabetes. Ischemic stroke showed a greater association with incident dementia than diabetes.

CONCLUSIONS: Mild degrees of hyperglycemia and presence of comorbidities were associated with incident dementia. Intervention during the prodromal stage of a chronic disease (e.g., prediabetes) could be considered for dementia prevention.

PMID:34711638 | DOI:10.2337/dc21-0957

Categories
Nevin Manimala Statistics

Non-urgent emergency department attendances in children: a retrospective observational analysis

Emerg Med J. 2021 Oct 28:emermed-2021-211431. doi: 10.1136/emermed-2021-211431. Online ahead of print.

ABSTRACT

INTRODUCTION: A significant proportion of ED attendances in children may be non-urgent attendances (NUAs), which could be better managed elsewhere. This study aimed to quantify NUAs and urgent attendances (UAs) in children to ED and determine which children present in this way and when.

METHODS: Dataset extracted from the CUREd research database containing linked data on the provision of care in Yorkshire and Humber. Analysis focused on children’s ED attendances (April 2014-March 2017). Summary statistics and odds ratios (OR) comparing NUAs and UAs were examined by: age, mode and time of arrival and deprivation alongside comparing summary statistics for waiting, treatment and total department times.

RESULTS: NUAs were more likely in younger children: OR for NUA in children aged 1-4 years, 0.82 (95% CI: 0.80 to 0.83), age 15 years, 0.39 (95% CI: 0.38 to 0.40), when compared with those under 1 year. NUAs were more likely to arrive out of hours (OOHs) compared with in hours: OR 1.19 (95% CI 1.18 to 1.20), and OOHs arrivals were less common in older children compared with those under 1 year: age 1-4 years, 0.87 (95% CI: 0.84 to 0.89) age 15 years, 0.66 (95% CI: 0.63 to 0.69). NUAs also spent less total time in the ED, with a median (IQR) of 98 min (60-147) compared with 127 min (80-185) for UAs.

CONCLUSION: A substantial proportion of ED attendances in children are NUAs. Our data suggest there are particular groups of children for whom targeted interventions would be most beneficial. Children under 5 years would be such a group, particularly in providing accessible, timely care outside of usual community care opening hours.

PMID:34711634 | DOI:10.1136/emermed-2021-211431

Categories
Nevin Manimala Statistics

Improved Prognosis of Treatment Failure in Cervical Cancer with Non-Tumor Positron Emission Tomography / Computed Tomography Radiomics

J Nucl Med. 2021 Oct 28:jnumed.121.262618. doi: 10.2967/jnumed.121.262618. Online ahead of print.

ABSTRACT

Background: Radiomics has been applied to predict recurrence in several disease sites, but current approaches are typically restricted to analyzing tumor features, neglecting non-tumor information in the rest of the body. The purpose of this work was to develop and validate a model incorporating non-tumor radiomics, including whole body features, to predict treatment outcomes in patients with previously untreated locoregionally advanced cervical cancer. Methods: We analyzed 127 cervical cancer patients treated definitively with chemoradiotherapy and intracavitary brachytherapy. All patients underwent pretreatment whole body 18F-FDG PET/CT. To quantify effects due to the tumor itself, the gross tumor volume (GTV) was directly contoured on the PET/CT. Meanwhile, to quantify effects arising from the rest of the body, the planning target volume (PTV) was deformably registered from each planning CT to the PET/CT, and a semi-automated approach combining seed-growing and manual contour review generated whole body muscle, bone, and fat segmentations on each PET/CT. A total of 965 radiomic features were extracted for GTV, PTV, muscle, bone, and fat. 95 patients were used to train a Cox model of disease recurrence including both radiomic and clinical features (age, stage, tumor grade, histology, and baseline complete blood cell counts), using bagging and split-sample-validation for feature reduction and model selection. To further avoid overfitting, the resulting models were tested for generalization on the remaining 32 patients, by calculating a risk score based on Cox regression and evaluating the c-index (c-index > 0.5 indicates predictive power). Results: Optimal performance was seen in a Cox model including one clinical biomarker (whether or not a tumor was stage III-IVA), two GTV radiomic biomarkers (PET gray-level size-zone matrix small area low gray level emphasis and zone entropy), one PTV radiomic biomarker (major axis length) and one whole body radiomic biomarker (CT Bone root mean square). In particular, stratification into high- and low-risk groups, based on the linear risk score from this Cox model, resulted in a hazard ratio [95% CI] of 0.019 [0.004, 0.082], an improvement over stratification based on clinical stage alone, which had a hazard ratio of 0.36 [0.16, 0.83]. Conclusion: Incorporating non-tumor radiomic biomarkers can improve the performance of prognostic models compared to using only clinical and tumor radiomic biomarkers. Future work should look to further test these models in larger, multi-institutional cohorts.

PMID:34711618 | DOI:10.2967/jnumed.121.262618

Categories
Nevin Manimala Statistics

Reply LTE, On Semi-quantitative Methods for Assessing Vascular 18FDG-PET Activity in Large-Vessel Vasculitis

J Nucl Med. 2021 Oct 28:jnumed.121.263158. doi: 10.2967/jnumed.121.263158. Online ahead of print.

NO ABSTRACT

PMID:34711615 | DOI:10.2967/jnumed.121.263158

Categories
Nevin Manimala Statistics

Protocol and statistical analysis plan for the Pragmatic Investigation of optimaL Oxygen Targets (PILOT) clinical trial

BMJ Open. 2021 Oct 28;11(10):e052013. doi: 10.1136/bmjopen-2021-052013.

ABSTRACT

INTRODUCTION: Mechanical ventilation of intensive care unit (ICU) patients universally involves titration of the fraction of inspired oxygen to maintain arterial oxygen saturation (SpO2). However, the optimal SpO2 target remains unknown.

METHODS AND ANALYSIS: The Pragmatic Investigation of optimaL Oxygen Targets (PILOT) trial is a prospective, unblinded, pragmatic, cluster-crossover trial being conducted in the emergency department (ED) and medical ICU at Vanderbilt University Medical Center in Nashville, Tennessee, USA. PILOT compares use of a lower SpO2 target (target 90% and goal range: 88%-92%), an intermediate SpO2 target (target 94% and goal range: 92%-96%) and a higher SpO2 target (target 98% and goal range: 96%-100%). The study units are assigned to a single SpO2 target (cluster-level allocation) for each 2-month study block, and the assigned SpO2 target switches every 2 months in a randomly generated sequence (cluster-level crossover). The primary outcome is ventilator-free days (VFDs) to study day 28, defined as the number of days alive and free of invasive mechanical ventilation from the final receipt of invasive mechanical ventilation through 28 days after enrolment.

ETHICS AND DISSEMINATION: The trial was approved by the Vanderbilt Institutional Review Board. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

TRIAL REGISTRATION NUMBER: The trial protocol was registered with ClinicalTrials.gov on 25 May 2018 prior to initiation of patient enrolment (ClinicalTrials.gov identifier: NCT03537937).

PMID:34711597 | DOI:10.1136/bmjopen-2021-052013

Categories
Nevin Manimala Statistics

Development of critical thinking skills of undergraduate students throughout the 4 years of nursing degree at a public university in Spain: a descriptive study

BMJ Open. 2021 Oct 28;11(10):e049950. doi: 10.1136/bmjopen-2021-049950.

ABSTRACT

OBJECTIVE: To analyse the critical thinking skills of students enrolled in the four academic years of the nursing degree at a public university belonging to the European Higher Education Area.

DESIGN: Cross-sectional, quantitative, descriptive study. Using the Critical Thinking Questionnaire to analyse the critical thinking skills in their substantive and dialogic dimension.

SETTING: Faculty of Nursing, Valladolid Public University in Spain, belonging to the European Higher Education Area.

PARTICIPANTS: The sample consisted of 215 first-year, second-year, third-year and fourth-year undergraduate nursing students.

MAIN OUTCOMES: The students of the four academic years were positively disposed towards critical thinking. The students of the final courses obtained higher average scores.

RESULTS: The study sample was 215 students, 19.1% men/80.9% women. The average score in the substantive dimension (3.81±0.53 points) was higher than that in the dialogic dimension (3.48±0.51 points) (p<0.001). They had a greater ability in listening and speaking (3.77±0.61 points) with respect to writing (3.65±0.61 points) and reading (3.52±0.43 points) (p<0.001). There are significant differences in the critical thinking average scores across academic years.

CONCLUSIONS: Nursing students displayed a greater critical thinking ability in its substantive dimension compared with the dialogic one. This reflects a greater ability in actions related to provide reasons and evidence that support their point of view. Identifying critical thinking skills in nursing students will help establish specific teaching methodologies focused on improving these skills.

PMID:34711594 | DOI:10.1136/bmjopen-2021-049950

Categories
Nevin Manimala Statistics

Baseline IL-6 is a biomarker for unfavorable tuberculosis treatment outcomes: a multi-site discovery and validation study

Eur Respir J. 2021 Oct 28:2100905. doi: 10.1183/13993003.00905-2021. Online ahead of print.

ABSTRACT

Pre-treatment IL-6 is a biomarker for unfavorable tuberculosis treatment outcomes independent of disease severity and, improves the performance of risk-prediction models comprising of established clinical predictors.

BACKGROUND: Biomarkers of unfavorable tuberculosis treatment outcomes are needed to accelerate new drug and regimen development. Whether plasma cytokine levels can predict unfavorable tuberculosis treatment outcomes is unclear.

METHODS: We identified and internally validated the association between 20 a-priori selected plasma inflammatory markers and unfavorable treatment outcomes of failure, recurrence and all-cause mortality among adults with drug-sensitive pulmonary tuberculosis in India. We externally validated these findings in two independent cohorts of predominantly diabetic and HIV coinfected tuberculosis patients in India and South Africa, respectively.

RESULTS: Pre-treatment IFN-γ, IL-13 and IL-6 were associated with treatment failure in the discovery analysis. Internal validation confirmed higher pre-treatment IL-6 concentrations among failure cases compared to controls. External validation among predominantly diabetic tuberculosis patients found an association between pre-treatment IL-6 concentrations and subsequent recurrence and death. Similarly, external validation among predominantly HIV coinfected tuberculosis patients found an association between pre-treatment IL-6 concentrations and subsequent treatment failure and death. In a pooled analysis of 363 tuberculosis cases from the Indian and South African validation cohorts, high pre-treatment IL-6 concentrations were associated with higher risk of failure (adjusted odds ratio [aOR]=2.16, 95%CI 1.08-4.33, p=0.02), recurrence (aOR=5.36, 95%CI 2.48-11.57, p<0.001) and death (aOR=4.62, 95%CI 1.95-10.95, p<0.001). Adding baseline IL-6 to a risk-prediction model comprising of low BMI, high smear grade and cavitation improved model performance by 15 percent (C-statistic of 0.66 versus 0.76, p=0.02).

CONCLUSION: Pre-treatment IL-6 is a biomarker for unfavorable tuberculosis treatment outcomes. Future studies should identify optimal IL-6 concentrations for point-of-care risk prediction.

PMID:34711538 | DOI:10.1183/13993003.00905-2021

Categories
Nevin Manimala Statistics

Elevated blood favipiravir levels are inversely associated with ferritin levels and induce the elevation of uric acid levels in COVID-19 treatment: A retrospective single-center study

J Infect Chemother. 2021 Oct 19:S1341-321X(21)00280-4. doi: 10.1016/j.jiac.2021.10.011. Online ahead of print.

ABSTRACT

INTRODUCTION: Measurement of blood Favipiravir (FPV) levels and accumulation of data in COVID-19 patients are critical for assessing FPV efficacy and safety. We performed a retrospective study based on measurements of blood levels of FPV and related factors in COVID-19 patients admitted to our hospital. Furthermore, we also investigated the association between blood FPV levels and uric acid level alterations before and after FPV administration.

METHODS: We enrolled 27 COVID-19 patients who had received FPV treatment at Hokushin General Hospital from April 1 to December 31, 2020. Age, gender, COVID-19 severity, presence of comorbidities, and laboratory data for each subject were investigated to identify factors that correlate with blood FPV levels. Uric acid levels were measured before and after FPV administration and a difference between the levels (i.e., a change of uric acid level) was evaluated.

RESULTS: When a significant univariate variable was input by the stepwise method and a combination of variables that maintained statistical superiority was searched, serum ferritin was the only factor that independently affected blood FPV level. Furthermore, in the high-FPV group (20 μg/mL or more), a significant increase in uric acid levels was observed after FPV administration. The increment value was significantly larger than that in the low-FPV group (less than 20 μg/mL).

CONCLUSIONS: Ferritin level was an important independent factor inversely affecting blood FPV level. Furthermore, a high blood FPV level induced the elevation of uric acid levels in COVID-19 treatment.

PMID:34711508 | DOI:10.1016/j.jiac.2021.10.011

Categories
Nevin Manimala Statistics

Use of an intravaginal spacer in young girls treated with brachytherapy for bladder neck rhabdomyosarcoma: Dosimetric impact for organs at risk sparing and acute tolerance

Cancer Radiother. 2021 Oct 25:S1278-3218(21)00255-9. doi: 10.1016/j.canrad.2021.09.010. Online ahead of print.

ABSTRACT

PURPOSE: Interstitial brachytherapy is indicated as part of a conservative strategy for children with bladder and/or prostate rhabdomyosarcoma (RMS), providing high local control probability with acceptable functional results. Vaginal and/or rectal complications were however reported, due to the close proximity to the implanted volume. We investigated the dosimetric impact of a vaginal spacer in terms of rectal and vaginal doses.

METHODS AND PATIENTS: Medical records of 12 consecutive female patients with bladder neck RMS, median age 32 months (range: 1.3-6 years), were reviewed. Five patients were treated prior to 2017 without a vaginal spacer and seven patients treated after 2017 had their brachytherapy delivered with a vaginal spacer placed at time of implant.

RESULTS: Minimal doses delivered to the most exposed 2cm3, 1cm3, and 0.5cm3 of the rectum were all statistically significantly lower among patients treated with a vaginal spacer, as compared to those treated without a spacer. Median rectal D2cm3 was 22GyEQD2 versus 38GyEQD2 (P=0.02), D1cm3 was 29GyEQD2 versus 51GyEQD2 (P=0.013), and D0.5cm3 was 32GyEQD2 versus 61GyEQD2 (P=0.017), with and without the vaginal spacer, respectively. The posterior vaginal wall D0.5cm3 dose was also significantly decreased, with median D0.5cm3 of 92GyEQD2 versus 54GyEQD2 (P<0.0001), with and without the spacer, respectively. Acute tolerance was excellent in all patients, with no need for replanning and no acute complication.

CONCLUSIONS: The use of vaginal spacers in brachytherapy of female pediatric patients with bladder neck RMS resulted in significantly decreased doses to the rectum and the posterior vaginal wall. Though the clinical impact of such dose reduction remains undemonstrated, routine utilization of a vaginal spacer could be a method to decrease long-term morbidity in these patients.

PMID:34711484 | DOI:10.1016/j.canrad.2021.09.010