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Nevin Manimala Statistics

Validation of the Clavien-Dindo grading system of complications for microsurgical treatment of unruptured intracranial aneurysms

Neurosurg Focus. 2021 Nov;51(5):E10. doi: 10.3171/2021.8.FOCUS20892.

ABSTRACT

OBJECTIVE: Microsurgery plays an essential role in managing unruptured intracranial aneurysms (UIAs). The Clavien-Dindo classification is a therapy-oriented grading system that rates any deviation from the normal postoperative course in five grades. In this study, the authors aimed to test the applicability of the Clavien-Dindo grade (CDG) in patients who underwent microsurgical treatment of UIAs.

METHODS: The records of patients who underwent microsurgery for UIAs (January 2013-November 2018) were retrieved from a prospective database. Complications at discharge and at short-term follow-up (3 months) were rated according to the Clavien-Dindo system. Patient outcomes were graded using the modified Rankin Scale (mRS) and the National Institutes of Health Stroke Scale (NIHSS). A descriptive statistic was used for data analysis.

RESULTS: Overall, 156 patients underwent 157 surgeries for 201 UIAs (size range 4-42 mm). Thirty-nine patients (25%) had complex UIAs. An adverse event (CDG ≥ I) occurred in 21 patients (13.5%) by the time of discharge. Among these, 10 patients (6.4%) presented with a new neurological deficit. Significant correlations existed between a CDG ≥ I and an increase in mRS and NIHSS scores (p < 0.001). Patients treated for complex aneurysms had a significantly higher risk of developing new neurological deficits (20.5% vs 1.7%, p = 0.007). At the 3-month follow-up, a CDG ≥ I was registered in 16 patients (10.3%); none presented with a new neurological deficit. A CDG ≥ I was associated with a longer hospital length of stay (LOS) (no complication vs CDG ≥ I, 6.2 ± 3.5 days vs 9.3 ± 7.7 days, p = 0.02).

CONCLUSIONS: The CDG was applicable to patients who received microsurgery of UIAs. A significant correlation existed between CDG and outcome scales, as well as LOS. The aneurysm complexity was significantly associated with a higher risk for new neurological deficit.

PMID:34724644 | DOI:10.3171/2021.8.FOCUS20892

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Nevin Manimala Statistics

Effects of an external ventricular drain alert protocol on venticulostomy placement time in the emergency department

Neurosurg Focus. 2021 Nov;51(5):E4. doi: 10.3171/2021.8.FOCUS21378.

ABSTRACT

OBJECTIVE: Timely ventriculostomy placement is critical in the management of neurosurgical emergencies. Prompt external ventricular drain (EVD) placement has been shown to improve long-term patient outcomes and decrease the length of ICU and hospital stays. Successful and efficient EVD placement requires seamless coordination among multiple healthcare teams. In this study, the authors sought to identify factors favoring delayed ventriculostomy via a quality improvement initiative and to implement changes to expedite EVD placement.

METHODS: Through process mapping, root cause analysis, and interviews with staff, the authors identified the lack of a standardized mechanism for alerting necessary healthcare teams as a major contributor to delays in EVD placement. In December 2019, an EVD alert system was developed to automatically initiate an EVD placement protocol and to alert the neurosurgery department, pharmacy, core laboratory, and nursing staff to prepare for EVD placement. The time to EVD placement was tracked prospectively using time stamps in the electronic medical record.

RESULTS: A total of 20 patients who underwent EVD placement between December 2019 and April 2021, during the EVD alert protocol initiation, and 18 preprotocol control patients (January 2018 to December 2019) met study inclusion criteria and were included in the analysis. The mean time to EVD placement in the control group was 71.88 minutes compared with 50.3 minutes in the EVD alert group (two-tailed t-test, p = 0.025). The median time to EVD placement was 64 minutes in the control group compared with 52 minutes in the EVD alert group (rank-sum test, p = 0.0184). All patients from each cohort exhibited behavior typical of stable processes, with no violation of Shewhart rules and no special cause variations on statistical process control charts.

CONCLUSIONS: A quality improvement framework helped identify sources of delays to EVD placement in the emergency department. An automated EVD alert system was a simple intervention that significantly reduced the time to EVD placement in the emergency department and can be easily implemented at other institutions to improve patient care.

PMID:34724637 | DOI:10.3171/2021.8.FOCUS21378

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Machine learning-augmented objective functional testing in the degenerative spine: quantifying impairment using patient-specific five-repetition sit-to-stand assessment

Neurosurg Focus. 2021 Nov;51(5):E8. doi: 10.3171/2021.8.FOCUS21386.

ABSTRACT

OBJECTIVE: What is considered “abnormal” in clinical testing is typically defined by simple thresholds derived from normative data. For instance, when testing using the five-repetition sit-to-stand (5R-STS) test, the upper limit of normal (ULN) from a population of spine-healthy volunteers (10.5 seconds) is used to identify objective functional impairment (OFI), but this fails to consider different properties of individuals (e.g., taller and shorter, older and younger). Therefore, the authors developed a personalized testing strategy to quantify patient-specific OFI using machine learning.

METHODS: Patients with disc herniation, spinal stenosis, spondylolisthesis, or discogenic chronic low-back pain and a population of spine-healthy volunteers, from two prospective studies, were included. A machine learning model was trained on normative data to predict personalized “expected” test times and their confidence intervals and ULNs (99th percentiles) based on simple demographics. OFI was defined as a test time greater than the personalized ULN. OFI was categorized into types 1 to 3 based on a clustering algorithm. A web app was developed to deploy the model clinically.

RESULTS: Overall, 288 patients and 129 spine-healthy individuals were included. The model predicted “expected” test times with a mean absolute error of 1.18 (95% CI 1.13-1.21) seconds and R2 of 0.37 (95% CI 0.34-0.41). Based on the implemented personalized testing strategy, 191 patients (66.3%) exhibited OFI. Type 1, 2, and 3 impairments were seen in 64 (33.5%), 91 (47.6%), and 36 (18.8%) patients, respectively. Increasing detected levels of OFI were associated with statistically significant increases in subjective functional impairment, extreme anxiety and depression symptoms, being bedridden, extreme pain or discomfort, inability to carry out activities of daily living, and a limited ability to work.

CONCLUSIONS: In the era of “precision medicine,” simple population-based thresholds may eventually not be adequate to monitor quality and safety in neurosurgery. Individualized assessment integrating machine learning techniques provides more detailed and objective clinical assessment. The personalized testing strategy demonstrated concurrent validity with quality-of-life measures, and the freely accessible web app (https://neurosurgery.shinyapps.io/5RSTS/) enabled clinical application.

PMID:34724641 | DOI:10.3171/2021.8.FOCUS21386

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Nevin Manimala Statistics

Clinical, Sociodemographic and Environmental Risk Factors for Acute Bacterial Diarrhea among Adults and Children over Five Years in Bangladesh

Am J Trop Med Hyg. 2021 Nov 1:tpmd210580. doi: 10.4269/ajtmh.21-0580. Online ahead of print.

ABSTRACT

In 2016, diarrheal disease was the eighth leading cause of mortality globally accounting for over 1.6 million deaths with the majority of deaths in adults and children over 5 years. This study aims to investigate the clinical, sociodemographic, and environmental risk factors associated with common bacterial acute diarrhea among adults and children over 5. Data were collected from March 2019 to March 2020 in patients over 5 years presenting with acute gastroenteritis at icddr,b. Stool samples were collected from each patient for culture and polymerase chain reaction (PCR) testing. Bivariate associations between independent variables and stool-testing indicating bacterial etiology were calculated. This analysis included 2,133 diarrheal patients of whom a bacterial enteropathogen was identified in 1,537 (72%). Detection of bacteria was associated with: younger age (OR 0.92; 95% CI: 0.88-0.96), lower mean arterial pressure (OR 0.84; 95% CI: 0.79-0.89), heart rate (OR 1.06; 95% CI: 1.01-1.10), percentage dehydration (OR 1.33; 95% CI: 1.13-1.55), respiration rate (OR 1.23; 95% CI: 1.04-1.46), lower mid-upper arm circumference (OR 0.97; 95% CI: 0.94-0.99), confused/lethargic mental status (OR 1.85; 95% CI: 1.11-3.25), rice watery stool (OR 1.92; 95% CI: 1.54-2.41), and vomiting more than three times in the past 24 hours (OR 1.30; 95% CI: 1.06-1.58). Higher monthly income (OR 0.92; 95% CI: 0.86-0.98), > 8 years of education (OR 0.79; 95% CI: 0.63-1.00), and having more than five people living at home (OR 0.80; 95% CI: 0.66-0.98) were associated with lower odds of bacterial diarrhea. These findings may help guide the development of predictive tools to aid in identifying patients with bacterial diarrhea for timely and appropriate use of antibiotics.

PMID:34724626 | DOI:10.4269/ajtmh.21-0580

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Mass Spectrometry-Based Technology and Workflows for Studying the Chemistry of Fungal Endophyte Derived Bioactive Compounds

ACS Chem Biol. 2021 Nov 1. doi: 10.1021/acschembio.1c00581. Online ahead of print.

ABSTRACT

Bioactive compounds have gained substantial attention in research and have conferred great advancements in the industrial and pharmacological fields. Highly diverse fungi and their metabolome serve as a big platform to be explored for their diverse bioactive compounds. Omics tools coupled with bioinformatics, statistical, and well-developed algorithm tools have elucidated immense knowledge about fungal endophyte derived bioactive compounds. Further, these compounds are subjected to chromatography-gas chromatography and liquid chromatography (LC), spectroscopy-nuclear magnetic resonance (NMR), and “soft ionization” technique-matrix-assisted laser desorption/ionization-time-of-flight (MALDI-TOF) based analytical techniques for structural characterization. The mass spectrometry (MS)-based approach, being highly sensitive, reproducible, and reliable, produces quick and high-profile identification. Coupling these techniques with MS has resulted in a descriptive account of the identification and quantification of fungal endophyte derived bioactive compounds. This paper emphasizes the workflows of the above-mentioned techniques, their advancement, and future directions to study the unraveled area of chemistry of fungal endophyte-derived bioactive compounds.

PMID:34724607 | DOI:10.1021/acschembio.1c00581

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Are single nucleotide polymorphisms rs7903146 and rs12255372 in transcription factor 7-like 2 gene associated with an increased risk for gestational diabetes mellitus in Egyptian women?

J Genet Eng Biotechnol. 2021 Nov 1;19(1):169. doi: 10.1186/s43141-021-00272-6.

ABSTRACT

BACKGROUND: Genetic variants in the transcription factor 7-like 2 (TCF7L2) gene are related with type 2 diabetes (T2D) and gestational diabetes mellitus (GDM) in various populations, but there are not enough statistics regarding GDM among Egyptian women. We aimed by this study to evaluate the effect of two polymorphisms of rs7903146 and rs12255372 in the TCF7L2 gene with the development of GDM among Egyptian women.

RESULTS: We enrolled 114 pregnant women with normal glucose tolerance and 114 with GDM according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) guidelines. We gathered records on blood pressure, body mass index (BMI), blood glucose level, hemoglobin A1C (HbA1c), and lipid profile. The genotyping of rs7903146 and rs12255372 polymorphisms was carried out using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). The statistical significance of prepregnancy BMI, fasting blood sugar (FBS), HbA1c, low-density lipoprotein (LDL), and total cholesterol (Tch) was higher, P < 0.001, in GDM women in comparison to pregnant women without GDM. CT and TT genotypes in rs7903146 SNP were 46.5% vs. 54%, P <0.04, OR; CI = 1.9 (1.0 to 3.78); TT carriers were 37.7% vs. 9.6%, P <0.001, OR (CI) = 8.9 (3.7-21.1), respectively. For the TCFL2 gene rs12255372 SNP, GT carriers were 48.2% vs. 39.5%, P= 0.004, OR (CI) = 2.3 (1.3-4.2), while TT carriers were 24.6% vs. 7.9%, P < 0.001, OR (CI) = 6 (2.5-14.3).

CONCLUSION: The study showed there is a significantly higher incidence of CT/TT genotypes in rs7903146 SNP and GT/TT genotypes in rs12255372 SNP in TCF7L2 gene among GDM women in comparison to healthy pregnant women (controls).

PMID:34724590 | DOI:10.1186/s43141-021-00272-6

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Reliability of Trial Information Across Registries for Trials With Multiple Registrations: A Systematic Review

JAMA Netw Open. 2021 Nov 1;4(11):e2128898. doi: 10.1001/jamanetworkopen.2021.28898.

ABSTRACT

IMPORTANCE: Clinical trial registries are important for gaining an overview of ongoing research efforts and for deterring and identifying publication bias and selective outcome reporting. The reliability of the information in trial registries is uncertain.

OBJECTIVE: To assess the reliability of information across registries for trials with multiple registrations.

EVIDENCE REVIEW: For this systematic review, 360 protocols of randomized clinical trials (RCTs) approved by research ethics committees in Switzerland, the UK, Canada, and Germany in 2012 were evaluated. Clinical trial registries were searched from March to September 2019 for corresponding registrations of these RCTs. For RCTS that were recorded in more than 1 clinical trial registry, key trial characteristics that should be identical among all trial registries (ie, sponsor, funding source, primary outcome, target sample size, trial status, date of first patient enrollment, results available, and main publication indexed) were extracted in duplicate. Agreement between the different trial registries for these key characteristics was analyzed descriptively. Data analyses were conducted from May 1 to November 30, 2020. Representatives from clinical trial registries were interviewed to discuss the study findings between February 1 and March 31, 2021.

FINDINGS: The analysis included 197 RCTs registered in more than 1 trial registry (151 in 2 registries and 46 in 3 registries), with 188 trials in ClinicalTrials.gov, 185 in the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT), 20 in ISRCTN, and 47 in other registries. The agreement of key information across all registries was as follows: 178 of 197 RCTs (90%; 95% CI, 85%-94%) for sponsor, 18 of 20 (90%; 95% CI, 68%-99%) for funding source (funding was not reported on ClinicalTrials.gov), 154 of 197 (78%; 95% CI, 72%-84%) for primary outcome, 90 of 197 (46%; 95% CI, 39%-53%) for trial status, 122 of 194 (63%; 95% CI, 56%-70%) for target sample size, and 43 of 57 (75%; 95% CI, 62%-86%) for the date of first patient enrollment when the comparison time was increased to 30 days (date of first patient enrollment was not reported on EudraCT). For results availability in trial registries, agreement was 122 of 197 RCTs (62%; 95% CI, 55%-69%) for summary data reported in the registry and 91 of 197 (46%; 95% CI, 39%-53%) for whether a published article with the main results was indexed. Different legal requirements were stated as the main reason for inconsistencies by representatives of clinical trial registries.

CONCLUSIONS AND RELEVANCE: In this systematic review, for a substantial proportion of registered RCTs, information about key trial characteristics was inconsistent across trial registries, raising concerns about the reliability of the information provided in these registries. Further harmonization across clinical trial registries may be necessary to increase their usefulness.

PMID:34724557 | DOI:10.1001/jamanetworkopen.2021.28898

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Association of Physical Activity, Including Amount and Maintenance, With All-Cause Mortality in Parkinson Disease

JAMA Neurol. 2021 Nov 1. doi: 10.1001/jamaneurol.2021.3926. Online ahead of print.

ABSTRACT

IMPORTANCE: The protective effects of physical activity (PA) against Parkinson disease (PD) development have been suggested; however, the association of PA with mortality in PD has rarely been investigated.

OBJECTIVE: To evaluate the association between PA and mortality in individuals with PD and determine how the amount and maintenance of PA are associated with mortality.

DESIGN, SETTING, AND PARTICIPANTS: This nationwide population-based cohort study used Korean National Health Insurance System data. Participants were included from January 1, 2010, and December 31, 2013, and were followed up until December 31, 2017. Data were analyzed from September 2020 to March 2021. Individuals who were newly diagnosed with PD were selected using the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code G20 and registration code V124 in the program for rare intractable diseases in 2010 through 2013. Individuals who underwent health checkups within 2 years before and after the PD diagnosis were enrolled. Those aged younger than 40 years or with missing data were excluded.

EXPOSURES: Physical activity levels were collected using self-reported questionnaires.

MAIN OUTCOMES AND MEASURES: All-cause mortality.

RESULTS: A total of 45 923 individuals were identified; 10 987 were enrolled, and 34 individuals younger than 40 years and 254 with missing data were excluded. A total of 10 699 individuals with PD were included; 4925 (46%) were male and 5774 (54%) were female, and the mean (SD) age was 69.2 (8.8) years. During the 8-year follow-up period, there were 1823 deaths (17%). The mortality rate was lower among individuals who were physically active vs inactive at all PA intensities (vigorous: hazard ratio [HR], 0.80 [95% CI, 0.69-0.93]; moderate: HR, 0.66 [95% CI, 0.55-0.78]; light: HR, 0.81 [95% CI, 0.73-0.90]). There was a significant inverse dose-response association between the total amount of PA and mortality (HRs: vigorous, 0.80 [95% CI, 0.69-0.93]; moderate, 0.66 [95% CI, 0.55-0.78]; light, 0.81 [95% CI, 0.73-0.90]; P < .001). Moreover, maintenance of PA was associated with the mortality rate. Individuals with PD who were physically active both before and after the PD diagnosis had the greatest reduction in mortality rate across all PA intensities (HRs: vigorous, 0.66 [95% CI, 0.50-0.88]; moderate, 0.49 [95% CI, 0.32-0.75]; light, 0.76 [95% CI, 0.66-0.89]). Individuals who started PA after receiving the PD diagnosis had a lower mortality rate than those who remained physically inactive (HRs: vigorous, 0.82 [95% CI, 0.70-0.97]; moderate, 0.69 [95% CI, 0.57-0.83]; light, 0.86 [95% CI, 0.78-0.98]).

CONCLUSIONS AND RELEVANCE: This analysis found a dose-response association between PA and all-cause mortality in PD. Reverse causality may exist, and future prospective randomized clinical trials are warranted to determine the effect of PA on mortality in PD.

PMID:34724534 | DOI:10.1001/jamaneurol.2021.3926

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Comparison of D65/10° and A/10° illuminant/observer systems for colour measurement of raw pork

Acta Sci Pol Technol Aliment. 2021 Oct-Dec;20(4):485-496. doi: 10.17306/J.AFS.0971.

ABSTRACT

BACKGROUND: In pork colour measurements, the value of each parameter depends on the type of illuminant used. The spectra of D65 and A illuminants show great differences, with illuminant A having greater emission in the red part of the visible spectrum. Therefore, its application in the colour measurements of the pork longissimus muscle should result in larger changes in redness (&Delta;a*) and hue angle (&Delta;h&deg;) and higher correlation between &Delta;a* and &Delta;h&deg; and pH48 and WHC. The purpose of this study was to compare the suitability of the illuminant/observer systems D65/10&deg; and A/10&deg; for colour measurements of pork longissimus muscle, using the CIELAB and CIELCh systems.

METHODS: The study involved 168 samples of longissimus lumborum muscle taken from 168 carcasses (mean weight 90.2 &plusmn;6.0 kg) of pigs slaughtered on an industrial processing line. The moisture content, crude protein, intramuscular fat content, WHC, and pH48 were determined. Colour measurements using CIELAB and CIELCh scales were carried out with both D65/10&deg; and A/10&deg; illuminant/observer systems and reflectance measurements. The chromatic absorbance value at 525 nm (A525p) and the relative amounts of MbO2, MetMb, and Mb were calculated according to methods proposed by Krzywicki (1979) and AMSA (2012). Meat samples were illuminated and differences in the values of colour parameters (&Delta;L*, &Delta;a*, &Delta;b*, &Delta;C*, &Delta;h&deg;), chromatic absorbance at 525 nm (&Delta;A525p), and in the relative amounts of chemical forms of myoglobin (&Delta;MbO2, &Delta;MetMb, &Delta;Mb) were determined. In addition, hue difference (&Delta;H) and total difference (&Delta;E) were calculated.

RESULTS: The values of correlation coefficients between moisture content (especially crude protein and intramuscular fat, and colour parameters) were low and often statistically insignificant. Higher and mostly significant values of correlation coefficients were found between colour parameters and WHC and pH48. The A/10&deg; system resulted in higher values of correlation coefficients than D65/10&deg; between (I) WHC, pH48 and (II) h&deg;, &Delta;a* and &Delta;h&deg;. At the same time, in the A/10&deg; system the combined effect of the relative amounts of myoglobin chemical forms on the variation of h&deg; values and the combined effect of changes (&Delta;) in their amounts on the variation of &Delta;h&deg; and &Delta;H and &Delta;E were greater than in D65/10&deg;, with the greatest effect of these changes (&Delta;) in the amount of MetMb.

CONCLUSIONS: Replacement of the illuminant/observer D65/10&deg; system with the A/10&deg; system in colour measurements of raw pork longissimus muscle changed the proportion of pigments and the relative number of chemical forms of myoglobin in influencing the values of colour parameters, primarily h&deg;. Therefore, using the A/10&deg; system for colour measurements allows us to better capture the differences (&Delta;) in redness &Delta;a* and especially in hue angle (&Delta;h&deg;), as well as hue difference (&Delta;H) and total difference (&Delta;E), with an increase in the relative amount of MetMb becoming the main determinant of these differences (&Delta;). At the same time, measurements using the A/10&deg; system increased the correlation coefficients between WHC and pH48 and changes in redness (&Delta;a*) and hue angle (&Delta;h&deg;). Therefore, the A/10&deg; system compared to the D65/10&deg; system may be more useful for measuring the colour stability of raw pork, especially the determination of &Delta;h&deg; and &Delta;H and &Delta;E. >.

PMID:34724372 | DOI:10.17306/J.AFS.0971

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The Association Between Medicaid Adult Dental Coverage And Children’s Oral Health

Health Aff (Millwood). 2021 Nov;40(11):1731-1739. doi: 10.1377/hlthaff.2021.01135.

ABSTRACT

Although all state Medicaid programs cover children’s dental care, Medicaid-eligible children are more likely to experience tooth decay than children in higher-income families. Using data from the 1999-2016 National Health and Nutrition Examination Survey and the 2003, 2007, and 2011-12 waves of the National Survey of Children’s Health, we examined the association between Medicaid adult dental coverage (an optional benefit) and children’s oral health. Adult dental coverage was associated with a statistically significant 5-percentage-point reduction in the prevalence of untreated caries among children after Medicaid-enrolled adults had access to coverage for at least one year. These policies were also associated with a reduction in parent-reported fair or poor child oral health with a two-year lag between the onset of the policy and the effect. Effects were concentrated among children younger than age twelve. We estimated declines in poor oral health among all racial and ethnic subgroups, although there was some evidence that non-Hispanic Black children experienced larger and more persistent effects than non-Hispanic White children. Future assessments of the costs and benefits of offering adult dental coverage may consider potential effects on the children of adult Medicaid enrollees.

PMID:34724426 | DOI:10.1377/hlthaff.2021.01135