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Nevin Manimala Statistics

Abbreviated Gadoxetic Acid-Enhanced MRI for the Detection of Liver Metastases in Patients With Potentially Resectable Pancreatic Ductal Adenocarcinoma

J Magn Reson Imaging. 2022 Jan 10. doi: 10.1002/jmri.28059. Online ahead of print.

ABSTRACT

BACKGROUND: Gadoxetic acid-enhanced magnetic resonance imaging (MRI) is useful in detecting liver metastases from pancreatic ductal adenocarcinoma (PDAC). However, the long examination time limits its utility in the initial workup of patients with PDAC.

PURPOSE: To evaluate the incremental value of an abbreviated gadoxetic acid-enhanced MRI for the detection of liver metastases in patients with PDAC.

STUDY TYPE: Retrospective.

POPULATION: Patients (N = 130) with potentially resectable PDAC (women, 58 [44.6%]).

FIELD STRENGTH/SEQUENCE: 1.5 T and 3 T; gradient dual-echo T1-weighted (in-phase and opposed-phase), fat-suppressed fast spin-echo T2-weighted, single-shot echo-planar diffusion-weighted, and three-dimensional fat-suppressed T1-weighted gradient-echo dynamic contrast-enhanced and hepatobiliary phase sequences, as well as contrast-enhanced computed tomography (CECT).

ASSESSMENT: Three radiologists independently reviewed three different image sets to detect liver metastases: set 1, CECT alone; set 2, CECT and abbreviated MRI comprising fat-suppressed T2-weighted, diffusion-weighted, and hepatobiliary phase images; and set 3, CECT and standard gadoxetic acid-enhanced MRI.

STATISTICAL TESTS: Figure of merit (FOM) was compared using the jackknife alternative free-response receiver operating characteristics, and other per-lesion and per-patient diagnostic parameters for each image set were compared using McNemar’s and Fisher’s test. P < 0.05 was considered statistically significant.

RESULTS: A total of 43 liver metastases were identified in 13 patients. Reader-averaged FOM to detect liver metastases were significantly higher for sets 2 (0.884) and 3 (0.886) than for set 1 (0.609), while they were comparable between sets 2 and 3 (P = 0.96). The mean per-patient sensitivities, negative predictive values, and accuracies were significantly higher for sets 2 and 3 than for set 1, while those between sets 2 and 3 were not significantly different (not applicable, P > 0.99, and P > 0.99, respectively).

DATA CONCLUSION: Gadoxetic acid-enhanced MRI combined with CECT had higher diagnostic performance than CECT alone for the detection of liver metastases in patients with PDAC. The incremental values were comparable for the abbreviated MRI and standard MRI.

LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY: Stage 2.

PMID:35005813 | DOI:10.1002/jmri.28059

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Left Ventricular Strain Measurements Derived from MR Feature Tracking: A Head-to-Head Comparison of a Higher Temporal Resolution Method With a Conventional Method

J Magn Reson Imaging. 2022 Jan 10. doi: 10.1002/jmri.28053. Online ahead of print.

ABSTRACT

BACKGROUND: Magnetic resonance feature tracking (MR-FT) is an imaging technique that quantifies both global and regional myocardial strain. Currently, conventional MR-FT provides a superior signal and contrast-to-noise ratio but has a relatively low temporal resolution. A higher temporal resolution MR-FT technique may provide improved results.

PURPOSE: To explore the impact of higher temporal resolution on left ventricular (LV) myocardial strain measurements using MR-FT.

STUDY TYPE: Prospective.

POPULATION: One hundred and fifty-three participants including five healthy subjects and patients with various cardiac diseases referred to MR for cardiac assessment.

FIELD STRENGTH: 3 T, balanced steady-state free precession sequence with and without compressed sensing (temporal resolution: 10 msec and 40 msec, respectively).

ASSESSMENT: Conventional (40 msec) and higher (10 msec) temporal resolution data were acquired in all subjects during the same scanning session. Global circumferential strain (GCS), global longitudinal strain (GLS), and global radial strain (GRS) as well as peak systolic and diastolic strain rates (SRs) were measured by MR-FT and compared between the two temporal resolutions. We also performed subgroup analyses according to heart rates (HRs) and LV ejection fraction (LVEF).

STATISTICAL TESTS: Paired t-test, Wilcoxon signed-rank test, linear regression analyses, Bland-Altman plots. A P value <0.05 was considered to be statistically significant.

RESULTS: GCS and GRS were significantly higher in the 10-msec temporal resolution studies compared to the 40-msec temporal resolution studies (GCS: -13.00 ± 6.58% vs. -12.51 ± 5.76%; GRS: 21.97 ± 14.54% vs. 20.62 ± 12.52%). In the subgroup analyses, significantly higher GLS, GCS, and GRS values were obtained in subjects with LVEF ≥50%, and significantly higher GCS and GRS values were obtained in subjects with HRs <70 bpm when assessed with the 10-msec vs. the 40-msec temporal resolutions. All the peak systolic and diastolic SRs were significantly higher in the higher temporal resolution acquisitions. This was also true for all subgroups.

DATA CONCLUSIONS: Higher temporal resolution resulted in significantly higher cardiac strain and SR values using MR-FT and could be beneficial, particularly in patients with LVEF ≥50% and HR <70 bpm.

LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY: Stage 1.

PMID:35005810 | DOI:10.1002/jmri.28053

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Doppler Imaging Assessment of Changes of Blood Flow in Adenomyosis After Higher-Dose Oxytocin: A Randomized Controlled Trial

J Ultrasound Med. 2022 Jan 10. doi: 10.1002/jum.15923. Online ahead of print.

ABSTRACT

OBJECTIVES: To assess the changes of blood flow in adenomyosis (AM) after higher-dose oxytocin (OT) in different doses, and to evaluate the safety for patients.

METHODS: A total of 124 patients with AM were randomly divided into 4 groups with continuous intravenous infusion of OT as 0.06, 0.12, 0.24 and 0.36 U/min, respectively. The changes of arteries of AM before and after intravenous infusion of OT were observed by color Doppler ultrasound. The changes of blood flow volume of the artery of AM before and after intravenous infusion of OT were compared among the 4 groups, and the vital signs and adverse drug reactions were monitored during intravenous drip.

RESULTS: During the trial, no severe adverse reactions occurred and the vital signs of all the patients were stable. Among the 4 groups, it was found that there was a significant difference in the change of blood flow volume of blood artery in AM lesions between 0.06 U/min OT group and the other three groups after intravenous drip of OT (P < .05), but there was no significant difference in blood flow volume among the three groups (P > .05), and the difference of adverse drug reactions was statistically significant with the increase of OT dose (P < .05).

CONCLUSION: OT can effectively reduce the blood flow volume of AM lesions, and continuous intravenous infusion of 0.12 U/min OT is an appropriate dose that can not only minimize the blood flow volume but also reduce the incidence of adverse drug reactions.

PMID:35005793 | DOI:10.1002/jum.15923

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Treatment for recurrent vulvovaginal candidiasis (thrush)

Cochrane Database Syst Rev. 2022 Jan 10;1:CD009151. doi: 10.1002/14651858.CD009151.pub2.

ABSTRACT

BACKGROUND: Recurrent vulvovaginal candidiasis (RVVC) affects up to 5% of women. No comprehensive systematic review of treatments for RVVC has been published.

OBJECTIVES: The primary objective was to assess the effectiveness and safety of pharmacological and non-pharmacological treatments for RVVC. The secondary objective was to assess patient preference of treatment options.

SEARCH METHODS: We conducted electronic searches of bibliographic databases, including CENTRAL, MEDLINE, Embase, and CINAHL (search date 6 October 2021). We also handsearched reference lists of identified trials and contacted authors of identified trials, experts in RVVC, and manufacturers of products for vulvovaginal candidiasis.

SELECTION CRITERIA: We considered all published and unpublished randomised controlled trials evaluating RVVC treatments for at least six months, in women with four or more symptomatic episodes of vulvovaginal candidiasis in the past year. We excluded women with immunosuppressive disorders or taking immunosuppressant medication. We included women with diabetes mellitus and pregnant women. Diagnosis of RVVC must have been confirmed by presence of symptoms and a positive culture and/or microscopy. We included all drug and non-drug therapies and partner treatment, assessing the following primary outcomes: • number of clinical recurrences per participant per year (recurrence defined as clinical signs and positive culture/microscopy); • proportion of participants with at least one clinical recurrence during the treatment and follow-up period; and • adverse events.

DATA COLLECTION AND ANALYSIS: Two authors independently reviewed titles and abstracts to identify eligible trials. Duplicate data extraction was completed independently by two authors. We assessed risk of bias as described in the Cochrane Handbook for Systematic Reviews of Interventions. We used the fixed-effects model for pooling and expressed the results as risk ratio (RR) with 95% confidence intervals (CI). Where important statistical heterogeneity was present we either did not pool data (I2 > 70%) or used a random-effects model (I2 40-70%). We used the GRADE tool to assess overall certainty of the evidence for the pooled primary outcomes.

MAIN RESULTS: Studies: Twenty-three studies involving 2212 women aged 17 to 67 years met the inclusion criteria. Most studies excluded pregnant women and women with diabetes or immunosuppression. The predominant species found on culture at study entry was Candida albicans. Overall, the included studies were small (<100 participants). Six studies compared antifungal treatment with placebo (607 participants); four studies compared oral versus topical antifungals (543 participants); one study compared different oral antifungals (45 participants); two studies compared different dosing regimens for antifungals (100 participants); one study compared two different dosing regimens of the same topical agent (23 participants); one study compared short versus longer treatment duration (26 participants); two studies assessed the effect of partner treatment (98 participants); one study compared a complementary treatment (Lactobacillus vaginal tablets and probiotic oral tablets) with placebo (34 participants); three studies compared complementary medicine with antifungals (354 participants); two studies compared ‘dermasilk’ briefs with cotton briefs (130 participants); one study examined Lactobacillus vaccination versus heliotherapy versus ciclopyroxolamine (90 participants); one study compared CAM treatments to an antifungal treatment combined with CAM treatments (68 participants). We did not find any studies comparing different topical antifungals. Nine studies reported industry funding, three were funded by an independent source and eleven did not report their funding source. Risk of bias: Overall, the risk of bias was high or unclear due to insufficient blinding of allocation and participants and poor reporting. Primary outcomes: Meta-analyses comparing drug treatments (oral and topical) with placebo or no treatment showed there may be a clinically relevant reduction in clinical recurrence at 6 months (RR 0.36, 95% CI 0.21 to 0.63; number needed to treat for an additional beneficial outcome (NNTB) = 2; participants = 607; studies = 6; I² = 82%; low-certainty evidence) and 12 months (RR 0.80, 95% CI 0.72 to 0.89; NNTB = 6; participants = 585; studies = 6; I² = 21%; low-certainty evidence). No study reported on the number of clinical recurrences per participant per year. We are very uncertain whether oral drug treatment compared to topical treatment increases the risk of clinical recurrence at 6 months (RR 1.66, 95% CI 0.83 to 3.31; participants = 206; studies = 3; I² = 0%; very low-certainty evidence) and reduces the risk of clinical recurrence at 12 months (RR 0.95, 95% CI 0.71 to 1.27; participants = 206; studies = 3; I² = 10%; very low-certainty evidence). No study reported on the number of clinical recurrences per participant per year. Adverse events were scarce across both treatment and control groups in both comparisons. The reporting of adverse events varied amongst studies, was generally of very low quality and could not be pooled. Overall the adverse event rate was low for both placebo and treatment arms and ranged from less than 5% to no side effects or complications.

AUTHORS’ CONCLUSIONS: In women with RVVC, treatment with oral or topical antifungals may reduce symptomatic clinical recurrences when compared to placebo or no treatment. We were unable to find clear differences between different treatment options (e.g. oral versus topical treatment, different doses and durations). These findings are not applicable to pregnant or immunocompromised women and women with diabetes as the studies did not include or report on them. More research is needed to determine the optimal medication, dose and frequency.

PMID:35005777 | DOI:10.1002/14651858.CD009151.pub2

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Radiation Dose Reduction in Congenital Heart Disease Patients During Cardiac Catheterization by a Novel Protocol

Turk Arch Pediatr. 2021 Jul 1;56(4):332-338. doi: 10.5152/TurkArchPediatr.2021.20068. eCollection 2021 Jul.

ABSTRACT

OBJECTIVE: Cardiac catheterization remains a major source of radiation exposure for patients with congenital heart disease. This study reports the magnitude of radiation with a 3.75 frame per second (fps) pulse fluoroscopy rate and compares the reduction with the previous 15 fps protocol during cardiac catheterization for pediatric and adult congenital heart disease.

MATERIAL AND METHODS: All diagnostic and interventional cardiac catheterization procedures from a single tertiary center were analyzed from January 1, 2014 to December 31, 2015, one year before and after implementing lower starting pulse fluoroscopy rates. The radiation dose was quantified as air kerma dose (mGy) and dose-area product (DAP; µGy/m2). Radiation exposure was analyzed for diagnostic and interventional procedures; the diagnostic group was subdivided into cyanotic and acyanotic patients, whereas the interventional group was subdivided according to the most common indications.

RESULTS: A total of 786 procedures were analyzed. The median fluoroscopy times and contrast amounts did not show a statistically significant difference between both periods (487 vs. 456 seconds and 42.5 vs. 45.3 cm3). The median air kerma for all procedures showed an 88% reduction after implementing lower pulse fluoroscopy rates (340-41 mGy). The doses were reduced significantly for diagnostic and interventional angiograms from 470 mGy and 162 mGy to 40 mGy and154 mGy. Among all patient groups, the most striking decrease was observed in the diagnostic procedures we use, of which fluoroscopy is more prominent than cine angiography.

CONCLUSION: We claim that novel radiation dose reduction protocols could be easily applied without increasing fluoroscopy time or losing image quality.

PMID:35005727 | PMC:PMC8655960 | DOI:10.5152/TurkArchPediatr.2021.20068

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Association of coronary artery calcification and thoracic aortic calcification with incident peripheral arterial disease in the Multi-Ethnic Study of Atherosclerosis (MESA)

Eur Heart J Open. 2021 Dec 3;1(3):oeab042. doi: 10.1093/ehjopen/oeab042. eCollection 2021 Nov.

ABSTRACT

AIMS: The association of subclinical atherosclerotic disease in the coronary arteries and thoracic aorta with incident peripheral arterial disease (PAD) is unknown. We investigated the association between coronary artery calcium score (CACs) and thoracic aortic calcium score (TACs) with incident clinical and subclinical PAD.

METHODS AND RESULTS: The Multi-Ethnic Study of Atherosclerosis (MESA) recruited 6814 men and women aged 45-84 from four ethnic groups who were free of clinical cardiovascular disease at enrolment. Coronary artery calcium score and thoracic aortic calcium score were measured from computed tomography scans. Participants with a baseline ankle-brachial index (ABI) ≤0.90 or >1.4 were excluded. Abnormal ABI was defined as ABI ≤0.9 or >1.4 at follow-up exam. Multivariable logistic regression and Cox proportional hazards models were used to test the associations between baseline CACs and TACs with incident abnormal ABI and clinical PAD, respectively. A total of 6409 participants (female: 52.8%) with a mean age of 61 years were analysed. Over a median follow-up of 16.7 years, 91 participants developed clinical PAD. In multivariable analysis, each unit increase in log (CACS + 1) and log (TACs + 1) were associated with 23% and 13% (P < 0.01for both) higher risk of incident clinical PAD, respectively. In 5725 (female: 52.6%) participants with an available follow-up ABI over median 9.2 years, each 1-unit increase in log (CACs + 1) and log (TACs + 1) were independently associated with 1.15-fold and 1.07-fold (P < 0.01for both) higher odds of incident abnormal ABI, respectively.

CONCLUSION: Higher baseline CACs and TACs predict abnormal ABI and clinical PAD independent of traditional cardiovascular risk factors and baseline ABI.

PMID:35005719 | PMC:PMC8717048 | DOI:10.1093/ehjopen/oeab042

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Criteria for judging the immune markers of COVID-19 disease vaccines

MedComm (2020). 2021 Dec 31;3(1):1-12. doi: 10.1002/mco2.109. eCollection 2022 Jan.

ABSTRACT

As severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) sweeping the world, effective and affordable vaccines are in urgent need. A reliable system for the assessment of SARS-CoV-2 vaccines would boost the development of vaccines and reduce the research cost. We constructed a logistic regression model and analyzed the relationship between antibody (Ab) level and efficacy of different vaccine types. The relationship between assessment dates and Ab levels was depicted by plotting the mean of Ab levels evolved over time and a fitted cubic polynomial model. Anti-spike immunoglobulin G (IgG) could best estimate the vaccine efficacy (VE) (adjusted R 2= 0.731) and neutralizing Ab to live SARS-CoV-2 also explained a fine relationship (adjusted R 2 = 0.577). Neutralizing Abs to live SARS-CoV-2 in inactivated virus vaccines reached a peak during days 40-60, and their receptor-binding domain (RBD)-IgG peaked during days 40-50. For messenger RNA (mRNA) and viral vector vaccines, their neutralizing Ab to live SARS-CoV-2 peaked later than day 40, and for RBD-IgG during days 30-50. For mRNA and viral vector vaccines, their peak time of Abs was later than that in inactivated virus vaccines. RBD-IgG peaked earlier than Ab to live SARS-CoV-2. Anti-spike IgG and Ab to live SARS-CoV-2 may be good immune markers for VE assessment.

PMID:35005708 | PMC:PMC8719528 | DOI:10.1002/mco2.109

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Heal the Healers: A pilot study evaluating the feasibility, acceptability, and exploratory efficacy of a Transcendental Meditation intervention for emergency clinicians during the coronavirus disease 2019 pandemic

J Am Coll Emerg Physicians Open. 2021 Dec 29;2(6):e12619. doi: 10.1002/emp2.12619. eCollection 2021 Dec.

ABSTRACT

OBJECTIVE: Emergency clinicians face elevated rates of burnout that result in poor outcomes for clinicians, patients, and health systems. The objective of this single-arm pilot study was to evaluate the feasibility of a Transcendental Meditation (TM) intervention for emergency clinicians during the coronavirus disease 2019 (COVID-19) pandemic and to explore the potential effectiveness in improving burnout, sleep, and psychological health.

METHODS: Emergency clinicians (physicians, nurses, and physician-assistants) from 2 urban hospitals were recruited to participate in TM instruction (8 individual or group in-person and remote sessions) for 3 months. Session attendance was the primary feasibility outcome (prespecified as attending 6/8 sessions), and burnout was the primary clinical outcome. Participant-reported measures of feasibility and validated measures of burnout, depression, anxiety, sleep disturbance, and stress were collected at baseline and the 1-month and 3-month follow-ups. Descriptive statistics and linear mixed-effects models were used.

RESULTS: Of the 14 physicians (46%), 7 nurses (22%), and 10 physician-assistants (32%) who participated, 61% were female (n = 19/32). TM training and at-home meditation practice was feasible for clinicians as 90.6% (n = 29/32) attended 6/8 training sessions and 80.6% self-reported meditating at least once a day on average. Participants demonstrated significant reductions in burnout (P < .05; effect sizes, Cohen’s d = 0.43-0.45) and in symptoms of depression, anxiety, stress, and sleep disturbance (P values < .001; Cohen’s d = 0.70-0.87).

CONCLUSION: TM training was feasible for emergency clinicians during the COVID-19 pandemic and led to significant reductions in burnout and psychological symptoms. TM is a safe and effective meditation tool to improve clinicians’ well-being.

PMID:35005707 | PMC:PMC8716568 | DOI:10.1002/emp2.12619

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Admissions to a Low-Resource Neonatal Unit in Malawi Using a Mobile App and Dashboard: A 1-Year Digital Perinatal Outcome Audit

Front Digit Health. 2021 Dec 23;3:761128. doi: 10.3389/fdgth.2021.761128. eCollection 2021.

ABSTRACT

Introduction: Understanding the extent and cause of high neonatal deaths rates in Sub-Saharan Africa is a challenge, especially in the presence of poor-quality and inaccurate data. The NeoTree digital data capture and quality improvement system has been live at Kamuzu Central Hospital, Neonatal Unit, Malawi, since April 2019. Objective: To describe patterns of admissions and outcomes in babies admitted to a Malawian neonatal unit over a 1-year period via a prototype data dashboard. Methods: Data were collected prospectively at the point of care, using the NeoTree app, which includes digital admission and outcome forms containing embedded clinical decision and management support and education in newborn care according to evidence-based guidelines. Data were exported and visualised using Microsoft Power BI. Descriptive and inferential analysis statistics were executed using R. Results: Data collected via NeoTree were 100% for all mandatory fields and, on average, 96% complete across all fields. Coverage of admissions, discharges, and deaths was 97, 99, and 91%, respectively, when compared with the ward logbook. A total of 2,732 neonates were admitted and 2,413 (88.3%) had an electronic outcome recorded: 1,899 (78.7%) were discharged alive, 12 (0.5%) were referred to another hospital, 10 (0.4%) absconded, and 492 (20%) babies died. The overall case fatality rate (CFR) was 204/1,000 admissions. Babies who were premature, low birth weight, out born, or hypothermic on admission, and had significantly higher CFR. Lead causes of death were prematurity with respiratory distress (n = 252, 51%), neonatal sepsis (n = 116, 23%), and neonatal encephalopathy (n = 80, 16%). The most common perceived modifiable factors in death were inadequate monitoring of vital signs and suboptimal management of sepsis. Two hundred and two (8.1%) neonates were HIV exposed, of whom a third [59 (29.2%)] did not receive prophylactic nevirapine, hence vulnerable to vertical infection. Conclusion: A digital data capture and quality improvement system was successfully deployed in a low resource neonatal unit with high (1 in 5) mortality rates providing and visualising reliable, timely, and complete data describing patterns, risk factors, and modifiable causes of newborn mortality. Key targets for quality improvement were identified. Future research will explore the impact of the NeoTree on quality of care and newborn survival.

PMID:35005696 | PMC:PMC8732863 | DOI:10.3389/fdgth.2021.761128

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COVID-19 Prognostic Models: A Pro-con Debate for Machine Learning vs. Traditional Statistics

Front Digit Health. 2021 Dec 23;3:637944. doi: 10.3389/fdgth.2021.637944. eCollection 2021.

ABSTRACT

The SARS-CoV-2 virus, which causes the COVID-19 pandemic, has had an unprecedented impact on healthcare requiring multidisciplinary innovation and novel thinking to minimize impact and improve outcomes. Wide-ranging disciplines have collaborated including diverse clinicians (radiology, microbiology, and critical care), who are working increasingly closely with data-science. This has been leveraged through the democratization of data-science with the increasing availability of easy to access open datasets, tutorials, programming languages, and hardware which makes it significantly easier to create mathematical models. To address the COVID-19 pandemic, such data-science has enabled modeling of the impact of the virus on the population and individuals for diagnostic, prognostic, and epidemiological ends. This has led to two large systematic reviews on this topic that have highlighted the two different ways in which this feat has been attempted: one using classical statistics and the other using more novel machine learning techniques. In this review, we debate the relative strengths and weaknesses of each method toward the specific task of predicting COVID-19 outcomes.

PMID:35005694 | PMC:PMC8734592 | DOI:10.3389/fdgth.2021.637944