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Nevin Manimala Statistics

Activated clotting time in inpatient diagnostic and interventional settings

J Thromb Thrombolysis. 2022 Jun 22. doi: 10.1007/s11239-022-02672-y. Online ahead of print.

ABSTRACT

Monitoring for the anticoagulant effect of unfractionated (UFH) at the point of care using activated clotting time in real time is vital where risk of thrombosis is high. Although monitoring UFH effect is a routine and important task, changing from one ACT instrument type or technology to another must be preceded by a clinical and statistical evaluation to determine the suitability and repeatability and establish normal and treatable ranges of this newer instrument. In this multi-center prospective evaluation we tested 1236 paired ACT+ samples, and 463 paired ACT-LR samples (1699 total) from enrolled study subjects. Clinical settings included CVOR cardiopulmonary bypass, at the beside in extracorporeal life support (ELS), the Cardiac Catheterization Lab (CCL) during diagnostic studies and percutaneous coronary interventions (PCI), interventional radiology procedures and EP interventions. This study found more consistent clinical performance from the GEM Hemochron 100 as compared to the current clinical model, the Hemochron Signature Elite. The bias of GEM Hemochron 100 for ACT+ and ACT-LR was greatest in the setting of the CVOR where ACT levels were high. ACT-LR measurements by the GEM Hemochron 100 were comparable to the SE when performed in settings of CCL, ECM, EP and ICU. Results obtained for both ACT-LR and ACT+ in all clinical settings in this study using the GEM Hemochron 100 are as accurate and more repeatable as those with the current clinically available Signature Elite.

PMID:35731496 | DOI:10.1007/s11239-022-02672-y

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Effectiveness and Safety of Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training: The SCAR Randomized Clinical Trial

JAMA Cardiol. 2022 Jun 22. doi: 10.1001/jamacardio.2022.1651. Online ahead of print.

ABSTRACT

IMPORTANCE: Guidelines recommend that cardiac rehabilitation (CR) exercise training should not start until 6 weeks after sternotomy, although this is not evidence based. Limited data suggest that starting earlier is not detrimental, but clinical trials are needed.

OBJECTIVE: To compare the effectiveness and safety of CR exercise training started either 2 weeks (early CR) or 6 weeks (usual-care CR) after sternotomy.

DESIGN, SETTING, AND PARTICIPANTS: This was an assessor-blind, noninferiority, parallel-group, randomized clinical trial that conducted participant recruitment from June 12, 2017, to March 17, 2020. Participants were consecutive cardiac surgery sternotomy patients recruited from 2 outpatient National Health Service rehabilitation centers: University Hospital, Coventry, UK, and Hospital of St Cross, Rugby, UK.

INTERVENTIONS: Participants were randomly assigned to 8 weeks of twice-weekly supervised CR exercise training starting either 2 weeks (early CR) or 6 weeks (usual-care CR) after sternotomy. Exercise training adhered to existing guidelines, including functional strength and cardiovascular components.

MAIN OUTCOMES AND MEASURES: Outcomes were assessed at baseline (inpatient after surgery), after CR (10 or 14 weeks after sternotomy), and 12 months after randomization. The primary outcome was the change in 6-minute walk test distance from baseline to after CR. Secondary outcomes included safety, functional fitness, and quality of life.

RESULTS: A total of 158 participants (mean [SD] age, 63 [11.5] years, 133 male patients [84.2%]) were randomly assigned to study groups; 118 patients (usual-care CR, 61 [51.7%]; early CR, 57 [48.3%]) were included in the primary analysis. Early CR was not inferior to usual-care CR (noninferiority margin, 35 m); the mean change in 6-minute walk distance from baseline to after CR was 28 m greater in the early CR group (95% CI, -11 to 66; P = .16). Mean differences for secondary outcomes were not statistically significant, indicating noninferiority of early CR. There were 46 vs 58 adverse events and 14 vs 18 serious adverse events in usual-care CR and early CR, respectively. There was no difference between the groups in the likelihood of participants having an adverse or serious adverse event.

CONCLUSIONS AND RELEVANCE: Starting exercise training from 2 weeks after sternotomy was as effective as starting 6 weeks after sternotomy for improving 6-minute walk distance. With appropriate precautions, clinicians and CR professionals can consider starting exercise training as early as 2 weeks after sternotomy.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03223558.

PMID:35731506 | DOI:10.1001/jamacardio.2022.1651

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Improved weighted ensemble learning for predicting the daily reference evapotranspiration under the semi-arid climate conditions

Environ Sci Pollut Res Int. 2022 Jun 22. doi: 10.1007/s11356-022-21410-8. Online ahead of print.

ABSTRACT

Evapotranspiration is an important quantity required in many applications, such as hydrology and agricultural and irrigation planning. Reference evapotranspiration is particularly important, and the prediction of its variations is beneficial for analyzing the needs and management of water resources. In this paper, we explore the predictive ability of hybrid ensemble learning to predict daily reference evapotranspiration (RET) under the semi-arid climate by using meteorological datasets at 12 locations in the Andalusia province in southern Spain. The datasets comprise mean, maximum, and minimum air temperatures and mean relative humidity and mean wind speed. A new modified variant of the grey wolf optimizer, named the PRSFGWO algorithm, is proposed to maximize the ensemble learning’s prediction accuracy through optimal weight tuning and evaluate the proposed model’s capacity when the climate data is limited. The performance of the proposed approach, based on weighted ensemble learning, is compared with various algorithms commonly adopted in relevant studies. A diverse set of statistical measurements alongside ANOVA tests was used to evaluate the predictive performance of the prediction models. The proposed model showed high-accuracy statistics, with relative root mean errors lower than 0.999% and a minimum R2 of 0.99. The model inputs were also reduced from six variables to only two for cost-effective predictions of daily RET. This shows that the PRSFGWO algorithm is a good RET prediction model for the semi-arid climate region in southern Spain. The results obtained from this research are very promising compared with existing models in the literature.

PMID:35731435 | DOI:10.1007/s11356-022-21410-8

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Crohn’s Disease Is Associated with Liver Fibrosis in Patients with Nonalcoholic Fatty Liver Disease

Dig Dis Sci. 2022 Jun 22. doi: 10.1007/s10620-022-07562-0. Online ahead of print.

ABSTRACT

BACKGROUND: Chronic inflammation in IBD is postulated to drive NAFLD progression from steatosis to fibrosis.

AIMS: To study the histopathological spectrum of NAFLD in Crohn disease (CD) and Ulcerative colitis (UC).

METHODS: Patients with biopsy proven NAFLD at a quaternary center from 2008 to 2018 were included in this retrospective analysis. Inflammatory bowel disease (IBD) diagnosed either clinically and/or endoscopically at the time of liver biopsy. Multivariable regression and propensity score (PS) weighted analysis were conducted. Statistical analysis were performed using SAS statistical software.

RESULTS: Among 1009 patients with NAFLD a diagnosis of IBD was identified in 50 cases (34 CD and 16 UC). On multivariable analysis; CD was independently associated with significantly higher odds of advanced fibrosis (AF) on liver biopsy (adjusted OR = 4.09, 95% CI = 1.40-11.94) compared to NAFLD patients without IBD. Similar results were obtained with both the overlap PS weighted model (OR = 3.17, 95% CI = 1.55-6.49) and the PS matched model (OR = 3.49, 95% CI = 1.50-8.13).

CONCLUSION: In a large cohort of patients with histologically well characterized NAFLD, AF was more common in CD patients than NAFLD patients without IBD. These findings must be confirmed in a larger cohort, but suggest CD patients with NAFLD could be at greater risk for liver fibrosis.

PMID:35731428 | DOI:10.1007/s10620-022-07562-0

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High Triglyceride-Glucose Index Is Associated with Poor Prognosis in Patients with Acute Pancreatitis

Dig Dis Sci. 2022 Jun 22. doi: 10.1007/s10620-022-07567-9. Online ahead of print.

ABSTRACT

BACKGROUND: Acute pancreatitis (AP) is a common gastrointestinal disease worldwide. Severe acute pancreatitis (SAP) is characterized as persistent organ failure with a mortality rate as high as 20-30%. Early assessment of the severity and screening out possible SAP is of great significance. Given that there is still a lack of both convenient and practical tools for evaluating SAP, we conducted this study to explore the association between TyG index and acute pancreatitis prognosis.

METHODS: A total of 353 in-patients diagnosed with acute pancreatitis in the Second Hospital of Shandong University were retrospectively enrolled from January 2018 to November 2021 in this study. According to the Atlanta Classification, they were divided into two groups based on the AP severity. Demographic information and clinical materials were retrospectively collected. The TyG index calculation formula is as follows: ln [fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL)/2]. Statistical analyses were performed using SPSS software (IBM version 22.0) and Medcalc software. Multivariable logistic regression analyses were used to investigate independent predictors for SAP. ROC curve was plotted to assess the predictive ability and cutoffs of TyG index.

RESULTS: A total of 353 AP patients were respectively enrolled in this study, of which 47 suffered from SAP. Compared with the non-SAP group, TyG index was significantly higher in the SAP group (10.44 ± 1.55 vs 9.33 ± 1.44, P < 0.001). Multivariate logistic regression analysis showed that TyG index was an independent risk factor for SAP (OR 1.835, 95% CI 1.380-2.442 P < 0.001), with a cutoff of 8.76 for non-HTG/AAP and 11.81 for HTG/AAP by ROC curve. TyG index of patients who suffered from SIRS, OF, APFC, and ANC was higher than those without (P < 0.05).

CONCLUSIONS: The triglyceride-glucose index is an independent risk factor for SAP. High TyG index is closely related to SAP and AP-related complications.

PMID:35731427 | DOI:10.1007/s10620-022-07567-9

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Comparison of total cold-water immersion’s effects to ice massage on recovery from exercise-induced muscle damage

J Exp Orthop. 2022 Jun 22;9(1):59. doi: 10.1186/s40634-022-00497-5.

ABSTRACT

PURPOSE: The purpose of the study is to compare the effects of total cold-water immersion to ice massage on muscle damage, performance, and delayed onset of muscle soreness.

METHODS: Sixty participants were randomized into two groups where they completed a muscle damage protocol. Afterward, muscle damage, muscle performance, and delayed onset muscle soreness were respectively measured by serum Creatine Kinase (CK) test, one-repetition maximum (1-RM) test, countermovement jump (CMJ) test, and visual analog scale (VAS). The measurements were taken at five different timelines (Baseline, 2 H, 24 H, 48 H, and 72 H).

RESULTS: Data showed that values of all within-group measures of the dependent variables had extremely significant statistical differences (p < 0.001) for both intervention groups. Serum CK values peaked at 24 H for both groups. At 72 H, serum CK values dropped to baseline values in the total cold-water immersion group, while remaining high in the ice massage group. At 72 H, the values of the 1-RM test, CMJ test, and VAS approximated baseline values only in the total cold-water immersion group (p < 0.001).

CONCLUSIONS: Total cold-water immersion (TCWI) was more effective when compared to ice massage (IM) on improving values of recovery from exercise-induced muscle damage (EIMD). Hence, this modality may be considered during athletic recovery to maximize athletic performance.

CLINICAL TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov under the trial registration number ( NCT04183816 ).

PMID:35731373 | DOI:10.1186/s40634-022-00497-5

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Contraception and Healthcare Utilization by Reproductive-Age Women Who Use Drugs in Rural Communities: a Cross-Sectional Survey

J Gen Intern Med. 2022 Jun 15. doi: 10.1007/s11606-022-07558-6. Online ahead of print.

ABSTRACT

BACKGROUND: Women who use drugs (WWUD) have low rates of contraceptive use and high rates of unintended pregnancy. Drug use is common among women in rural U.S. communities, with limited data on how they utilize reproductive, substance use disorder (SUD), and healthcare services.

OBJECTIVE: We determined contraceptive use prevalence among WWUD in rural communities then compared estimates to women from similar rural areas. We investigated characteristics of those using contraceptives, and associations between contraceptive use and SUD treatment, healthcare utilization, and substance use.

DESIGN: Rural Opioids Initiative (ROI) – cross-sectional survey using respondent-driven sampling (RDS) involving eight rural U.S. regions (January 2018-March 2020); National Survey on Family Growth (NSFG) – nationally-representative U.S. household reproductive health survey (2017-2019).

PARTICIPANTS: Women aged 18-49 with prior 30-day non-prescribed opioid and/or non-opioid injection drug use; fecundity determined by self-reported survey responses.

MAIN MEASURES: Unweighted and RDS-weighted prevalence estimates of medical/procedural contraceptive use; chi-squared tests and multi-level linear regressions to test associations.

KEY RESULTS: Of 855 women in the ROI, 36.8% (95% CI 33.7-40.1, unweighted) and 38.6% (95% CI 30.7-47.2, weighted) reported contraceptive use, compared to 66% of rural women in the NSFG sample. Among the ROI women, 27% had received prior 30-day SUD treatment via outpatient counseling or inpatient program and these women had increased odds of contraceptive use (aOR 1.50 [95% CI 1.08-2.06]). There was a positive association between contraception use and recent medications for opioid use disorder (aOR 1.34 [95% CI 0.95-1.88]) and prior 6-month primary care utilization (aOR 1.32 [95% CI 0.96-1.82]) that did not meet the threshold for statistical significance.

CONCLUSION: WWUD in rural areas reported low contraceptive use; those who recently received SUD treatment had greater odds of contraceptive use. Improvements are needed in expanding reproductive and preventive health within SUD treatment and primary care services in rural communities.

PMID:35731368 | DOI:10.1007/s11606-022-07558-6

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Efficacy of Miniscrew-Assisted Rapid Palatal Expansion (MARPE) in late adolescents and adults with the Dutch Maxillary Expansion Device: a prospective clinical cohort study

Clin Oral Investig. 2022 Jun 22. doi: 10.1007/s00784-022-04577-9. Online ahead of print.

ABSTRACT

OBJECTIVES: To provide a higher degree of evidence on the efficacy of Miniscrew-Assisted Rapid Palatal Expansion (MARPE) in late adolescents and adults, thereby applying the Dutch Maxillary Expansion Device (D-MED).

MATERIALS AND METHODS: D-MED was developed as an individualized, 3D-designed, and fabricated MARPE appliance supported by 4 palatal miniscrews. Patients from the age of 16 onwards with transverse maxillary deficiency were enrolled consecutively. Pre-expansion and immediate post-expansion CBCTs and intra-oral scans were acquired and measurements of skeletal, alveolar, and dental expansion as well as dental and periodontal side-effects were performed.

RESULTS: Thirty-four patients were enrolled (8 men, 26 women) with mean age 27.0 ± 9.4 years. A success rate of 94.1% was achieved (32/34 patients). The mean expansion duration, or mean observation time, was 31.7 ± 8.0 days. The mean expansion at the maxillary first molars (M1) and first premolars (P1) was 6.56 ± 1.70 mm and 4.19 ± 1.29 mm, respectively. The expansion was 60.4 ± 20.1% skeletal, 8.1 ± 27.6% alveolar, and 31.6 ± 20.1% dental at M1 and 92.2 ± 14.5% skeletal, 0.0 ± 18.6% alveolar, and 7.8 ± 17.7% dental at P1, which was both statistically (p < 0.001) and clinically significant. Buccal dental tipping (3.88 ± 3.92° M1; 2.29 ± 3.89° P1), clinical crown height increase (0.12 ± 0.31 mm M1; 0.04 ± 0.22 mm P1), and buccal bone thinning (- 0.31 ± 0.49 mm M1; – 0.01 ± 0.45 mm P1) were observed, while root resorption could not be evaluated.

CONCLUSIONS: MARPE by application of D-MED manifested its efficacy in a prospective clinical setting, delivering a high amount of skeletal expansion with limited side-effects in late adolescents and adults.

CLINICAL RELEVANCE: Higher quality evidence is supportive of MARPE as a safe and successful non-surgical treatment option for transverse maxillary deficiency.

PMID:35731323 | DOI:10.1007/s00784-022-04577-9

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The impact of COVID-19 on medium term weight loss and comorbidities in patients undergoing bariatric surgery and its association with psychological wellbeing

Surg Endosc. 2022 Jun 22. doi: 10.1007/s00464-022-09377-6. Online ahead of print.

ABSTRACT

BACKGROUND: The COVID-19 epidemic imposed significant stressors on individuals and changed how medical care is delivered. The affect that this stress has placed on the field of bariatric surgery and the associated outcomes is not well established.

METHODS: A retrospective review of a prospectively collected database from a single academic institution was conducted. Weight loss and comorbidity outcomes were compared between a cohort of patients operated on during the pandemic and a matched group operated on prior to COVID-19. GAD-7 and PHQ-9 questionnaires were used to assess for anxiety and depression, respectively.

RESULTS: A total of 329 and 155 patients were enrolled in the pre-pandemic and COVID-19 groups respectively. There were no significant differences in pre-operative BMI (p = 0.437) or comorbidities: Type II DM (p = 0.810), hypertension (p = 0.879), sleep apnea (p = 0.502), and hyperlipidemia (p = 0.227). Post-operatively, weight loss was comparable at all time points out to 1 year. Type II DM resolution rates were higher in the control cohort at 6 months (p = 0.007), but not at 12 months (p = 1.000). There was no statistically significant difference in resolution rates between the control group and the COVID-19 group for the other measured comorbidities. There was no difference in objective measures of anxiety and depression when comparing the two groups (both p > 0.05).

CONCLUSIONS: The COVID-19 pandemic has fundamentally changed how society and medical systems function. Focusing on pre-operative dietary training and screening for inadequately managed psychological comorbidities yielded similar weight loss outcomes notwithstanding the significant societal and individual stressors with which patients were faced.

PMID:35731301 | DOI:10.1007/s00464-022-09377-6

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Natural monoterpenes-laden electrospun fibrous scaffolds for endodontic infection eradication

Odontology. 2022 Jun 22. doi: 10.1007/s10266-022-00722-8. Online ahead of print.

ABSTRACT

This investigation aimed to synthesize poly(D,L-lactide) (PLA)-based fibrous scaffolds containing natural essential oils (i.e., linalool and citral) and determine their antimicrobial properties and cytocompatibility as a clinically viable cell-friendly disinfection strategy for regenerative endodontics. PLA-based fibrous scaffolds were fabricated via electrospinning with different concentrations of linalool and citral. The micromorphology and average diameter of the fibers was investigated through scanning electron microscopy (SEM). The chemical composition of the scaffolds was inferred by Fourier-transform infrared spectroscopy (FTIR). Antimicrobial efficacy against Enterococcus faecalis and Actinomyces naeslundii was also evaluated by agar diffusion and colony-forming units (CFU) assays. The scaffolds’ cytocompatibility was determined using dental pulp stem cells (DPSCs). Statistical analyses were performed and the significance level was set at α = 5%. Linalool and citral’s incorporation in the PLA fibrous scaffolds was confirmed in the FTIR spectra. SEM images indicate no morphological changes upon inclusion of the essential oils, except the reduced diameter of 40% linalool-laden fibers (p < 0.05). Importantly, significant antimicrobial properties were reported for citral-containing scaffolds for CFU/mL counts (p < 0.05), while only 20% and 40% linalool-laden scaffolds reduced CFU/mL (p < 0.05). Meanwhile, the inhibition halos were verified in a concentration-dependent manner for all monoterpenes-laden scaffolds. Citral- and linalool-laden PLA-based fibrous scaffolds showed acceptable cytocompatibility. The incorporation of natural monoterpenes did not alter the scaffolds’ fibrous morphology, promoted antimicrobial action against endodontic pathogens, and preserved DPSCs viability. Linalool- and citral-laden electrospun scaffolds hold promise as naturally derived antimicrobial therapeutics for applications in regenerative endodontics.

PMID:35731305 | DOI:10.1007/s10266-022-00722-8