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Nevin Manimala Statistics

Risk Factors for Intraoperative Seizures in Glioma Surgery: Electrocorticography Matters

J Clin Neurophysiol. 2021 Apr 30. doi: 10.1097/WNP.0000000000000854. Online ahead of print.

ABSTRACT

PURPOSE: Few and contradictory data are available regarding intraoperative seizures during surgery for low-grade gliomas. Aim of this study was to evaluate possible risk factors for the occurrence of IOS.

METHODS: The authors performed a retrospective analysis of 155 patients affected by low-grade gliomas and tumor-related epilepsy, who underwent surgery in our Department, between 2007 and 2018. A statistical analysis was performed by means of univariate and multivariate regression to evaluate any possible correlation between seizure occurrence and several demographic, clinical, neurophysiological, and histopathological features.

RESULTS: Intraoperative seizure occurred in 39 patients (25.16%) with a total of 62 seizure events recorded. Focal seizures were the prevalent seizure type: among them, 39 seizures did not show motor signs, being those with only electrographic and/or with cognitive features the most represented subtypes. Twenty-six seizures occurring during surgery were not spontaneous: direct cortical stimulation with Penfield paradigm was the most prevalent evoking factor. The univariate analysis showed that the following prognostic factors were statistically associated with the occurrence of intraoperative seizure: the awake technique (P = 0.01) and the interictal epileptiform discharges detected on the baseline electrocorticography (ECoG) (P < 0.001). After controlling for confounding factors with multivariate analysis, the awake surgery and the epileptic ECoG pattern kept statistical significance.

CONCLUSIONS: The awake surgery procedure and the epileptic ECoG pattern are risk factors for intraoperative seizure. ECoG is mandatory to detect electrographic seizures or seizures without motor signs.

PMID:34038932 | DOI:10.1097/WNP.0000000000000854

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Screening electrocardiogram in young athletes and military members: a systematic review and meta-analysis

J Athl Train. 2021 May 26. doi: 10.4085/1062-6050-0746.20. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine the effect of electrocardiogram (ECG) screening on prevention of sudden cardiac arrest and death (SCA/D) in young athletes and military members.

DATA SOURCES: MEDLINE, Embase, Cochrane CENTRAL, Web of Science, BIOSIS, Scopus, SPORT discus, PEDro, and clinicaltrials.gov were searched from inception to dates between 2/21/19 and 7/29/19.

STUDY SELECTION: Randomized and non-randomized controlled trials, where pre-participation examination including ECG was the primary intervention used to screen athletes or military 40 years of age or younger. Accepted controls were no screening, usual care, or pre-participation examination without ECG. 3 published studies , and one conference abstract were identified for inclusion.

DATA EXTRACTION: In all four studies, risk of bias was assessed with the Cochrane risk of bias tool, and found to be generally high. Two studies had data extracted for random effects meta-analysis, and the remaining study and conference abstract were included in narrative review. Overall quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Data Synthesis: Four non-randomized studies (11,689,172 participants) were included, all at high risk of bias. Pooled data from two studies (n= 3,869,274; very low quality evidence) observed an inconclusive 42% relative decrease in risk of sudden cardiac death (RR 0.58; 95% CI 0.23, 1.45), equating to an absolute risk reduction of .0016% The findings were consistent with a potential 67% relative decrease to a 45% relative increased risk in participants screened with ECG. Heterogeneity was found to be high as measured with I2 statistic (71%). Data from the remaining study and abstract were similarly inconclusive.

CONCLUSION: Existing evidence for the effect of ECG screening is inconclusive and of very low quality. Our meta-analysis observed that screening ECG may result in considerable benefit or harm to participants. Higher quality studies are needed to reduce this uncertainty. PROSPERO Registration: CRD42019125560.

PMID:34038955 | DOI:10.4085/1062-6050-0746.20

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Fetal loss after chorionic villus sampling in twin pregnancies

Ultrasound Obstet Gynecol. 2021 May 26. doi: 10.1002/uog.23694. Online ahead of print.

ABSTRACT

OBJECTIVES: To estimate the chorionic villus sampling (CVS) related risk of fetal loss after adjustment for chorionicity, nuchal translucency thickness (NT), intertwin discordance in crown-rump length (CRL), maternal demographic characteristics and serum pregnancy associated plasma protein-A (PAPP-A) and free ß-human chorionic gonadotropin (hCG).

METHODS: This was a multicentre study from eight fetal medicine units in which the leadership were trained at the Harris Birthright research centre for fetal medicine in London and the protocols for screening, invasive testing and pregnancy management are similar. The study population of 8581 twin pregnancies undergoing ultrasound examination at 11-13 weeks’ gestation, included 316 dichorionic (DC) and 129 monochorionic (MC) twins that had CVS. Multivariable logistic regression analysis with backward step wise elimination was used to examine whether CVS provided a significant independent contribution in the prediction of risk of fetal loss after adjusting for maternal and pregnancy characteristics, including materal age, racial origin, weight, method of conception, smoking status, parity, chorionicity, intertwin discordance in CRL, fetal NT ≥95th percentile, free ß-hCG and PAPP-A MoM. Similarly, within the CVS groups multivariable logistic regression analysis was used to investigate the effect of the number of intrauterine needle insertions and size of the needles on the risk of fetal loss.

RESULTS: There are four main findings of this study. First, in twin pregnancies undergoing CVS, compared to those that do not have CVS, there is a 2-fold increased risk of fetal loss at <24 weeks’ gestation and loss at any stage in pregnancy. Second, the factors providing a significant independent contribution in the prediction of miscarriage or fetal loss in twin pregnancies are increased maternal weight, Black racial origin, monochorionicity and more so monoamnionicity, large intertwin discordance in CRL and high fetal NT and in the case of total fetal loss there is also a contribution from low serum PAPP-A. Third, there is a trend for an increased risk of fetal loss from CVS after adjustment for maternal and pregnancy characteristics but this does not reach statistical significance. Fourth, in the twin pregnancies that had CVS there is no significant contribution to fetal loss from the number of intrauterine needle insertions or needle size.

CONCLUSION: The 2-fold increased risk of fetal loss following CVS in twin pregnancies can to a great extent be explained by maternal and pregnancy characteristics rather than the invasive procedure itself. This article is protected by copyright. All rights reserved.

PMID:34038977 | DOI:10.1002/uog.23694

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Comparison of the Demographics and Visit Characteristics of Patients Who Left the Pediatric Emergency Department Without Being Seen With Those Who Were Evaluated in the Emergency Department

Pediatr Emerg Care. 2021 Jun 1;37(6):e329-e333. doi: 10.1097/PEC.0000000000002447.

ABSTRACT

BACKGROUND: We compared those patients who left without being seen (LWBS) with those who stay for evaluation and determined which subsets were more likely to depart prematurely in the largest pediatric population studied to date.

METHODS: We retrospectively extracted data from the electronic medical records of all pediatric patients who visited the emergency department between January 1, 2013, and December 31, 2015. The demographics and visit characteristics were compared between patients who LWBS and those seen by a provider. Bivariate and multivariate analyses were used to determine the odds for premature departure of specific groups within the population.

RESULTS: Of the 271,364 pediatric patients visiting the emergency department during the 3-year study period, 3835 (1.4%) LWBS by a provider. The mean age of those LWBS was younger, and the odds of leaving slightly decreased as the patient’s age increased (odds ratio [OR], 0.98). Those triaged as having “nonurgent” medical conditions had a statistically significant increase in odds of premature departure when compared with those with “urgent” medical conditions (OR, 1.16). Patients arriving during the evening and overnight hours had a much greater odds of LWBS (OR, 6.7 and 7.3, respectively).

CONCLUSIONS: Our findings demonstrated and confirmed that age, time of arrival, and acuity level upon presentation were predictors of patients leaving before evaluation. This can guide institutions with staffing and flow processes as they attempt to reduce LWBS rates but also raises further questions as to whether these subsets go forward to have worse clinical outcomes after leaving prematurely.

PMID:34038929 | DOI:10.1097/PEC.0000000000002447

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Practice Guideline: Use of Quantitative Electroencephalography for the Diagnosis of Mild Traumatic Brain Injury: Report of the Guideline Committee of the American Clinical Neurophysiology Society

J Clin Neurophysiol. 2021 Apr 30. doi: 10.1097/WNP.0000000000000853. Online ahead of print.

ABSTRACT

Despite many decades of research, controversy regarding the utility of quantitative EEG (qEEG) for the accurate diagnosis of mild traumatic brain injury (mTBI) remains. This guideline is meant to assist clinicians by providing an expert review of the clinical usefulness of qEEG techniques for the diagnosis of mTBI. This guideline addresses the following primary aim: For patients with or without posttraumatic symptoms (abnormal cognition or behavior), does qEEG either at the time of injury or remote from the injury, as compared with current clinical diagnostic criteria, accurately identify those patients with mTBI (i.e., concussion)? Secondary aims included differentiating between mTBI and other diagnoses, detecting mTBI in the presence of central nervous system medications, and pertinence of statistical methods for measurements of qEEG components. It was found that for patients with or without symptoms of abnormal cognition or behavior, current evidence does not support the clinical use of qEEG either at the time of the injury or remote from the injury to diagnose mTBI (level U). In addition, the evidence does not support the use of qEEG to differentiate mTBI from other diagnoses or detect mTBI in the presence of central nervous system medications, and suitable statistical methods do not exist when using qEEG to identify patients with mTBI. Based upon the current literature review, qEEG remains an investigational tool for mTBI diagnosis (class III evidence).

PMID:34038930 | DOI:10.1097/WNP.0000000000000853

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Nevin Manimala Statistics

Dynamic prediction and analysis based on restricted mean survival time in survival analysis with nonproportional hazards

Comput Methods Programs Biomed. 2021 May 9;207:106155. doi: 10.1016/j.cmpb.2021.106155. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: In the process of clinical diagnosis and treatment, the restricted mean survival time (RMST), which reflects the life expectancy of patients up to a specified time, can be used as an appropriate outcome measure. However, the RMST only calculates the mean survival time of patients within a period of time after the start of follow-up and may not accurately portray the change in a patient’s life expectancy over time.

METHODS: The life expectancy can be adjusted for the time the patient has already survived and defined as the conditional restricted mean survival time (cRMST). A dynamic RMST model based on the cRMST can be established by incorporating time-dependent covariates and covariates with time-varying effects. We analyzed data from a study of primary biliary cirrhosis (PBC) to illustrate the use of the dynamic RMST model, and a simulation study was designed to test the advantages of the proposed approach. The predictive performance was evaluated using the C-index and the prediction error.

RESULTS: Considering both the example results and the simulation results, the proposed dynamic RMST model, which can explore the dynamic effects of prognostic factors on survival time, has better predictive performance than the RMST model. Three PBC patient examples were used to illustrate how the predicted cRMST changed at different prediction times during follow-up.

CONCLUSIONS: The use of the dynamic RMST model based on the cRMST allows for the optimization of evidence-based decision-making by updating personalized dynamic life expectancy for patients.

PMID:34038865 | DOI:10.1016/j.cmpb.2021.106155

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Epidemic spreading in an expanded parameter space: the supercritical scaling laws and subcritical metastable phases

Phys Biol. 2021 May 26. doi: 10.1088/1478-3975/ac059d. Online ahead of print.

ABSTRACT

While the mathematical laws of uncontrolled epidemic spreading are well known, the statistical physics of Coronavirus epidemics with containment measures is currently lacking. The modelling of available data of the first wave of the Covid-19 pandemic in 2020 over 230 days, in different countries representative of different containment policies is relevant to quantify the efficiency of these policies to face the containment of any successive wave. At this aim we have built a 3D phase diagram tracking the simultaneous evolution and the interplay of the doubling time, Td, and the reproductive number, Rt measured using the methodological definition used by the Robert Koch Institute. In this expanded parameter space three different main phases, supercritical, critical and subcritical are identified. Moreover, we have found that in the supercritical regime with Rt>1 the doubling time is smaller than 40 days. In this phase we have established the power law relation between Td and (Rt-1)- with the exponent  depending on the definition of reproductive number. In the subcritical regime where Rt<1 and Td>100 days, we have identified arrested metastable phases where Td is nearly constant.

PMID:34038897 | DOI:10.1088/1478-3975/ac059d

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Clinimetric Criteria for Patient-Reported Outcome Measures

Psychother Psychosom. 2021 May 26:1-11. doi: 10.1159/000516599. Online ahead of print.

ABSTRACT

Patient-reported outcome measures (PROMs) are self-rated scales and indices developed to improve the detection of the patients’ subjective experience. Given that a considerable number of PROMs are available, it is important to evaluate their validity and usefulness in a specific research or clinical setting. Published guidelines, based on psychometric criteria, do not fit in with the complexity of clinical challenges, because of their quest for homogeneity of components and inadequate attention to sensitivity. Psychometric theory has stifled the field and led to the routine use of scales widely accepted yet with a history of poor performance. Clinimetrics, the science of clinical measurements, may provide a more suitable conceptual and methodological framework. The aims of this paper are to outline the major limitations of the psychometric model and to provide criteria for clinimetric patient-reported outcome measures (CLIPROMs). The characteristics related to reliability, sensitivity, validity, and clinical utility of instruments are critically reviewed, with particular reference to the differences between clinimetric and psychometric approaches. Of note is the fact that PROMs, rating scales, and indices developed according to psychometric criteria may display relevant clinimetric properties. The present paper underpins the importance of the clini-metric methodology in choosing the appropriate PROMs. CLIPROM criteria may also guide the development of new indices and the validation of existing PROMs to be employed in clinical settings.

PMID:34038901 | DOI:10.1159/000516599

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Quality by design optimization of a liquid chromatographic-tandem mass spectrometric method for the simultaneous analysis of structurally heterogeneous pharmaceutical compounds and its application to the rapid screening in wastewater and surface water samples by large volume direct injection

J Chromatogr A. 2021 May 8;1649:462225. doi: 10.1016/j.chroma.2021.462225. Online ahead of print.

ABSTRACT

This study focused on the Analytical Quality by Design (AQbD) optimization of the chromatographic separation and mass spectrometric detection of a wide group of structurally heterogeneous model pharmaceutical compounds (PhCs) and transformation products (TPs), chosen to cover the challenging issues of the co-presence of compounds characterized by (i) a wide range of physicochemical properties, (ii) the same mass transitions, and (iii) different ionisation modes. Italian consumption of PhCs were also considered as election criteria of target analytes. Octadecyl and pentafluorophenyl stationary phases, acetonitrile/methanol ratios and acidity of the eluents, column temperature, initial organic phase percentage, and elution gradient were investigated by AQbD, aiming at optimizing critical resolutions, sensitivities, and analysis time. Statistically significant models were obtained in most cases with fitting and cross-validation coefficients in the ranges of 0.681-0.998 and 0.514-0.967, respectively. After optimization, the analysis of target analytes was performed in a single chromatographic run, adopting a mixed acquisition mode based on scheduled acquisition windows comprising both single polarity and continuous polarity switching. For most investigated analytes the method provided detection limits in the sub-ng/L to low ng/L range, meeting for macrolides the sensitivity requested by the “Watch List” 2018/840/EU. The optimized method was applied to the direct injection analysis of PhCs and TPs in four wastewater treatment plant (WWTP) effluents and surface water (SW) samples collected in the receiving water bodies. Absolute values of matrix effect were found to be far higher than 20% for most target analytes in most samples. Seventeen PhCs and two TPs were quantified in at least one sample, at the wide concentration range of about 1-3200 ng/L. The most occurring PhCs in both WWTP effluents and SWs were levofloxacin (202-1239 and 100-830 ng/L), furosemide (865-3234 and 230-880 ng/L), ketoprofen (295-1104 and 270-490 ng/L), and ibuprofen (886-3232 and 690-1440 ng/L).

PMID:34038785 | DOI:10.1016/j.chroma.2021.462225

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The burden of Arcanobacterium haemolyticum pharyngitis: A systematic review and management algorithm

Int J Pediatr Otorhinolaryngol. 2021 May 13;146:110759. doi: 10.1016/j.ijporl.2021.110759. Online ahead of print.

ABSTRACT

INTRODUCTION: Arcanobacterium haemolyticum causes pharyngotonsillitis in children and young adults. It is rarely isolated in pharyngeal swabs as testing for it is not routine. Data on complications, management, and antibiotic susceptibility testing is limited. We sought to review the available literature on the presentation and management of A. haemolyticum pharyngotonsillitis in this age group.

METHODS: A systematic review of eligible studies reporting pharyngotonsillitis and related complications in children and young adults caused by A. haemolyticum was conducted. Literature from case reports, case series, and available cohorts was compiled. Data were analyzed using descriptive statistics.

RESULTS: The initial database search yielded 63 articles, after applying exclusion criteria 17 studies were included. 191 patients were identified with a median age of 16.5 years. The most common presentation was throat pain reported in 93.7% of patients. Tonsillar exudates, fever at presentation and rash were present in more than half of the reviewed cases. The diagnosis was established by a positive culture on a pharyngeal swab in 98.8% of swabs collected. Complications described included peritonsillar abscesses, Lemierre’s syndrome, pneumonia, and sepsis. Penicillin was the first line antibiotic in 81% of patients followed by macrolides in 19 patients (18%).

CONCLUSIONS: A. haemolyticum occurs in children and young adults and may result in complications. Our review supports its susceptibility to penicillin. We suggest a diagnostic and management algorithm to guide clinicians in targeted testing and aid with decision making regarding timely and appropriate antibiotic therapy, in an effort to reduce the burden of its complications.

PMID:34038812 | DOI:10.1016/j.ijporl.2021.110759