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Nevin Manimala Statistics

Subaxial Spine Fractures: A Comparison of Patient-reported Outcomes and Complications Between Anterior and Posterior Surgery

Spine (Phila Pa 1976). 2021 Sep 1;46(17):E926-E931. doi: 10.1097/BRS.0000000000003979.

ABSTRACT

STUDY DESIGN: Observational study on prospectively collected data.

OBJECTIVES: The aim of this study was to compare long-term patient-reported outcomes and complications after anterior or posterior cervical spine surgery for subaxial fractures.

SUMMARY OF BACKGROUND DATA: There is no consensus in the literature regarding the optimal surgical approach when treating spine fractures in the subaxial region.

METHODS: A total of 200 individuals who had been treated with either anterior or posterior surgery due to a subaxial single segment, or single vertebra, injury between 2006 and 2016 and had at least 1 year follow-up were identified in the Swedish Spine register. Cases were matched 1:1 for age (±5 years). Outcomes were Neck Disability Index (NDI) and EQ-5D-3L, and reoperations, mortality, and surgeon- and patient-reported wound complications within 90 days. t Tests and χ2 tests were used statistical comparisons.

RESULTS: At follow-up, NDI was 23 (21) in the anterior group and 29 (21) in the posterior group (P = 0.07). EQ-5D-3L index was 0.62 (0.37) in the anterior group and 0.54 (0.39) in the posterior group (P = 0.13). Patient satisfaction was higher in the anterior group (89% vs. 73%, P = 0.03). No deaths occurred within the first 90 days after surgery, six individuals in the anterior group and three individuals in the posterior group were reoperated (P = 0.31), and five individuals in the anterior group and 24 in the posterior group suffered a wound infection (P < 0.001).

CONCLUSION: Anterior surgery and posterior surgery were associated with similar neck disability and general quality of life at follow-up, whereas anterior surgery was associated with higher patient satisfaction and lower infection rates.Level of Evidence: 3.

PMID:34384090 | DOI:10.1097/BRS.0000000000003979

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Nevin Manimala Statistics

Comparing Smoking Cessation Interventions among Underserved Patients Referred for Lung Cancer Screening: A Pragmatic Trial Protocol

Ann Am Thorac Soc. 2021 Aug 12. doi: 10.1513/AnnalsATS.202104-499SD. Online ahead of print.

ABSTRACT

Smoking burdens are greatest among underserved patients. Lung cancer screening (LCS) reduces mortality among individuals at risk for smoking-associated lung cancer. Although LCS programs must offer smoking cessation support, the interventions that best promote cessation among underserved patients in this setting are unknown. This stakeholder-engaged, pragmatic randomized clinical trial (RCT) will compare the effectiveness of four interventions promoting smoking cessation among underserved patients referred for LCS. Using an additive study design, all four arms provide standard “Ask-Advise-Refer” care. Arm 2 adds free or subsidized pharmacologic cessation aids; Arm 3 adds financial incentives up to $600 for cessation; and Arm 4 adds a mobile device-delivered episodic future thinking tool to promote attention to long-term health goals. We hypothesize that smoking abstinence rates will be higher with the addition of each intervention when compared to Arm 1. We will enroll 3,200 adults with LCS orders at four United States health systems. Eligible patients include those who smoke at least one cigarette daily and self-identify as a member of an underserved group (i.e., Black or Latinx, a rural resident, completed a high school education or less, and/or with a household income <200% of the federal poverty line). The primary outcome is biochemically confirmed smoking abstinence sustained through 6 months. Secondary outcomes include abstinence sustained through 12 months, other smoking-related clinical outcomes, and patient-reported outcomes. This pragmatic RCT will identify the most effective smoking cessation strategies that LCS programs can implement to reduce smoking burdens affecting underserved populations. Clinical trial registered with ClinicalTrials.gov (NCT04798664). Date of registration: March 12, 2021. Date of trial launch: May 17, 2021.

PMID:34384042 | DOI:10.1513/AnnalsATS.202104-499SD

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Nevin Manimala Statistics

Exploring the role of soil types on defense and fitness traits of silverleaf nightshade (Solanum elaeagnifolium), a worldwide invasive species through a field survey in the native range

Plant Signal Behav. 2021 Aug 12:1964163. doi: 10.1080/15592324.2021.1964163. Online ahead of print.

ABSTRACT

Silverleaf nightshade (Solanum elaeagnifolium) is a highly successful invasive weed that has caused agricultural losses both in its home and invaded ranges. Surveying 50 sub-populations over 36,000 km2 in its native range in South Texas, we investigated the interactions among soil type, population size, plant height, herbivory, and plant defenses in its home range with the expectation that populations growing in the plant’s preferred sandier soils would host larger colonies of healthier and better defended plants. At each sampling location, on randomly selected plants, we measured height, insect herbivore damage, and presence, and density of internode spines. Soil type was determined using the NRCS Web Soil Survey and primarily grouped into sand, clay, or urban. Our results show a tradeoff between growth and defense with larger colonies and taller plants in clay soils, but smaller colonies of shorter, spinier plants in sandy soils. We also observed decreased herbivory in urban soils, further confirming the plant’s ability to survive and even be strengthened by highly disturbed conditions. This study is a starting point for a better understanding of silverleaf nightshade’s ecology in its home range and complicates the assumption that it thrives best in sandy soils.

PMID:34384043 | DOI:10.1080/15592324.2021.1964163

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Nevin Manimala Statistics

Intra-operative cerebral blood flow assessment by indocyanine green video-angiography after temporary arterial occlusion in aneurysm surgery and its clinical implications: a prospective study

J Cerebrovasc Endovasc Neurosurg. 2021 Aug 13. doi: 10.7461/jcen.2021.E2020.10.003. Online ahead of print.

ABSTRACT

OBJECTIVE: Indocyanine green video angiography (ICG-VA) is a routine while performing vascular surgery to assess patency of perforators, completeness of clipping and/or to assess patency of anastomosis. Its usefulness in assessing cerebral blood flow and perfusion is not well studied. This study is aimed to assess the cerebral blood flow and perfusion after temporary clipping and to correlate with the risk of ischemia.

METHODS: Prospective analysis of intra-operative ICG-VA performed during temporary arterial occlusion in 38 patients from January 2014 to December 2018 was conducted. Co-relation with post-operative MR diffusion weighted imaging (MR DWI) in terms of vascular territory of interest within 48 hours of surgery was performed. Clinical outcome was assessed using modified Rankin Scale (mRS) score 1-month post-surgery.

RESULTS: 43 aneurysms in 38 patients clipped using ICG-VA were included in this study. No side effect of ICG dye was seen in any patients. The number of times temporary clips applied had a direct relationship to the delay in appearance of ICG in the surgical field which became statistically significant after application of 3rd temporary clip. Nine (23.7%) patients developed ischemia following the procedure confirmed by post-operative MR DWI and all the ischemic cases had visible decrease in ICG fluorescence post-temporary clipping.

CONCLUSIONS: No previous study had tried to assess the intraoperative cerebral blood flow and perfusion during temporary clipping of parent vessels during aneurysm surgery. The use of ICG-VA can be extended to assess perfusion in desired territory by merely assessing the degree of opacification.

PMID:34384018 | DOI:10.7461/jcen.2021.E2020.10.003

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Nevin Manimala Statistics

DNA methylation as a mediator of associations between the environment and chronic diseases: A scoping review on application of mediation analysis

Epigenetics. 2021 Aug 12:1-27. doi: 10.1080/15592294.2021.1959736. Online ahead of print.

ABSTRACT

DNA methylation (DNAm) is one of the most studied epigenetic modifications. DNAm has emerged as a key biological mechanism and biomarkers to test associations between environmental exposure and outcomes in epidemiological studies. Although previous studies have focused on associations between DNAm and either exposure/outcomes, it is useful to test for mediation of the association between exposure and outcome by DNAm. The purpose of this scoping review is to introduce the methodological essence of statistical mediation analysis and to examine emerging epidemiological research applying mediation analyses. We conducted this scoping review for published peer-reviewed journals on this topic using online databases (PubMed, Scopus, Cochrane, and CINAHL) ending in December 2020. We extracted a total of 219 articles by initial screening. After reviewing titles, abstracts, and full texts, a total of 69 articles were eligible for this review. The breakdown of studies assigned to each category was 13 for smoking (18.8%), 8 for dietary intake and famine (11.6%), 6 for other lifestyle factors (8.7%), 8 for clinical endpoints (11.6%), 22 for environmental chemical exposures (31.9%), 2 for socioeconomic status (SES) (2.9%), and 10 for genetic factors and race (14.5%). In this review, we provide an exposure-wide summary for the mediation analysis using DNAm levels. However, we found heterogenous methods and interpretations in mediation analysis with typical issues such as different cell compositions and tissue-specificity. Further accumulation of evidence with diverse exposures, populations and with rigorous methodology will be expected to provide further insight in the role of DNAm in disease susceptibility.

PMID:34384035 | DOI:10.1080/15592294.2021.1959736

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Validation of the scored Patient-Generated Subjective Global Assessment short form (PG-SGA SF) as a prognostic tool for incurable cancer patients

JPEN J Parenter Enteral Nutr. 2021 Aug 12. doi: 10.1002/jpen.2251. Online ahead of print.

ABSTRACT

BACKGROUND & AIM: The Patient-Generated Subjective Global Assessment short form (PG-SGA SF) is a standardized tool for assessing nutritional risk in patients with cancer. The aim of this study was to propose and validate a cutoff point for the PG-SGA SF score related to the prognosis of patients with incurable cancer in exclusive palliative care.

METHODS: This data analysis is from a prospective cohort study carried out patients with incurable cancer at the National Cancer Institute in Brazil. A total sample (n = 2,144) was randomly divided into groups: (A) training (n = 1,072), to determine the most accurate PG-SGA SF cutoff; and (B) validation (n = 1,072), to test the predictive accuracy of this cutoff point. The receiver operating characteristic (ROC) curve was plotted to determine the best cutoff point of the PG-SGA SF related to death. Concordance statistics (c-statistic) were used to test the predictive accuracy of the models. Kaplan Meier’s curve and the Cox hazard model were used to verify a prognostic value of the cutoff point.

RESULTS: PG-SGA SF score ≥15 was found to be the best cutoff based on 90-day mortality with good accuracy discrimination (C-statistic ≥0.74). Patients whose PG-SGA SF score ≥15 had a shorter survival of 32 days (interquartile range, IQR: 12-75) vs. 83 days (IQR: 31-90), p-value <0.001, and higher risk of death (hazard ratio: 2.20; 95% CI: 1.64-2.95).

CONCLUSIONS: The proposed PG-SGA SF cutoff score is valid and alongside its usefulness in nutritional triage, it could provide prognostic value for patients with incurable cancer.

CLINICAL RELEVANCY STATEMENT: Patients with incurable cancer in palliative care are often undernourished, and have shortened overall survival. As nutritional status in constantly evaluated in these patients, tools commonly used could also have prognostic value, broadening their applicability. PG-SGA is a validated tool for patients with cancer, and alongside its usefulness in screening for nutritional risk, it could provide prognostic value, guiding interventions better suited to each patient. This article is protected by copyright. All rights reserved.

PMID:34383972 | DOI:10.1002/jpen.2251

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Nevin Manimala Statistics

Fracture Resistance of Single-Unit Implant-Supported Crowns: Effects of Prosthetic Design and Restorative Material

J Prosthodont. 2021 Aug 12. doi: 10.1111/jopr.13415. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the fracture resistance and fracture patterns of single implant-supported crowns with different prosthetic designs and materials.

MATERIALS AND METHODS: One hundred and forty-four identical crowns were fabricated from zirconia-reinforced lithium silicate (ZLS), leucite-based (LGC), and lithium disilicate (LDS) glass-ceramics, reinforced composite (RC), translucent zirconia (ZR), and ceramic-reinforced PEEK (P). These crowns were divided into 3 subgroups according to restoration design: cementable crowns on a prefabricated titanium abutment, cement-retained crown on a zirconia-titanium base abutment, and screw-cement crown (n = 8). After adhesive cementation, restorations were subjected to thermal-cycling and loaded until fracture. The fracture patterns were evaluated under a stereomicroscope. Statistical analysis was performed by using 2-way ANOVA/Bonferroni multiple comparison post hoc test (α = .05).

RESULTS: For each prosthetic design, ZR presented the highest fracture resistance (P≤.005). Other than the differences with ZLS and RC for screw-cement crowns (P>.05) and RC for crowns on zirconia-titanium base abutments (P>.05), LGC showed the lowest fracture resistance. P endured higher loads than LDS (P<.001), except for the crowns on zirconia-titanium base abutments (P>.05). Cementable crowns presented the highest fracture resistance (P<.001), other than LGC and LDS. The differences between LGC crowns (P>.05) or LDS crowns on prefabricated titanium and zirconia-titanium abutments were nonsignificant (P = .133). Fragmented crown fracture was predominant in most of the restorations. Screw and abutment fractures were observed in ZR screw-cement crowns, and all P crowns were separated from the abutments.

CONCLUSIONS: Restorative material and restoration design affect the fracture resistance and fracture pattern of implant-supported single-unit restorations. Clinicians may restore single-unit implants in premolar sites with the materials and prosthetic designs tested in the present study. This article is protected by copyright. All rights reserved.

PMID:34383979 | DOI:10.1111/jopr.13415

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Nevin Manimala Statistics

Access flow volume (Qa) and survival in a hemodialysis population: An analysis of 5208 Qa measurements over a 9-year period

Nephrol Dial Transplant. 2021 Aug 12:gfab242. doi: 10.1093/ndt/gfab242. Online ahead of print.

ABSTRACT

BACKGROUND: Aim of the study was to determine associations between characteristics of arteriovenous access (AVA) access flow volume (Qa, mL/min) and four year freedom from cardiovascular mortality (4yr-CVM) in hemodialysis (HD) patients.

METHODS: HD patients who received a primary AVA between January 2010 and December 2017 in one center were analyzed. Initial Qa was defined as the first Qa value obtained in a well-functioning AVA by a two-needle dilution technique. Actual Qa was defined as access flow at a random point of time. Changes in actual Qa were expressed per 3-month periods. CVM was assessed according to the ERA-EDTA classification. The optimal cut-off point for initial Qa was identified by a receiver operating characteristic curve. A joint modelling statistical technique determined longitudinal associations between Qa characteristics and 4yr-CVM.

RESULTS: A total of 5208 Qa measurements (165 patients, male n = 103; age 70±12 years, autologous AVA n = 146, graft n = 19) were analyzed. During follow-up (Dec 2010-Jan 2018, median 36 months), 79 patients (48%) died. An initial Qa < 900 mL/min was associated with an increased 4y-CVM risk (HR: 4.05; 95% CI [1.94-8.43], P<0.001). After 4 years, freedom from CVM was 34% lower in patients with a Qa < 900 mL/min (53 ±7% vs. Qa ≥ 900 mL/min: 87 ±4%, P <0.001). An association between increases in actual Qa over 3-month periods and mortality was found (HR: 4.48 per 100mL/min, 95% CI [1.44-13.97], P =0.010) indicating that patients demonstrating increasing Qa were more likely to die. By contrast, actual Qa per se was not related to survival.

CONCLUSIONS: Studying novel arteriovenous access Qa characteristics may contribute to understanding excess CVM in HD patients.

PMID:34383950 | DOI:10.1093/ndt/gfab242

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Nevin Manimala Statistics

Cardiovascular Outcomes in Patients With Mitochondrial Disease in the United States: A Propensity Score Analysis

Tex Heart Inst J. 2021 Jul 1;48(3):e207243. doi: 10.14503/THIJ-20-7243.

ABSTRACT

Mitochondrial disease comprises a wide range of genetic disorders caused by mitochondrial dysfunction. Its rarity, however, has limited the ability to assess its effects on clinical outcomes. To evaluate this relationship, we collected data from the 2016 National Inpatient Sample, which includes data from >7 million hospital stays. We identified 705 patients (mean age, 22 ± 20.7 yr; 54.2% female; 67.4% white) whose records included the ICD-10-CM code E88.4. We also identified a propensity-matched cohort of 705 patients without mitochondrial disease to examine the effect of mitochondrial disease on major adverse cardiovascular events, including all-cause in-hospital death, cardiac arrest, and acute congestive heart failure. Patients with mitochondrial disease were at significantly greater risk of major adverse cardiovascular events (odds ratio [OR]=2.42; 95% CI, 1.29-4.57; P=0.005), systolic heart failure (OR=2.37; 95% CI, 1.08-5.22; P=0.027), and all-cause in-hospital death (OR=14.22; 95% CI, 1.87-108.45; P<0.001). These findings suggest that mitochondrial disease significantly increases the risk of inpatient major adverse cardiovascular events.

PMID:34383956 | DOI:10.14503/THIJ-20-7243

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Aztreonam/avibactam effect on pharmacodynamic indices for mutant selection of Escherichia coli and Klebsiella pneumoniae harbouring serine- and New Delhi metallo-β-lactamases

J Antimicrob Chemother. 2021 Aug 12:dkab292. doi: 10.1093/jac/dkab292. Online ahead of print.

ABSTRACT

OBJECTIVES: Ceftazidime/avibactam is not active against MBL-producing bacteria. Combining ceftazidime/avibactam or avibactam with aztreonam can counter the resistance of MBL-producing Enterobacterales. The aim of this study was to evaluate whether the addition of avibactam could reduce or close the mutant selection window (MSW) of aztreonam in Escherichia coli and Klebsiella pneumoniae harbouring MBLs; MSW is a pharmacodynamic (PD) parameter for the selection of emergent resistant mutants.

METHODS: In vitro susceptibility of 19 clinical isolates to ceftazidime/avibactam, aztreonam alone, and in co-administration (aztreonam/ceftazidime/avibactam and aztreonam/avibactam) was determined, as well as the mutant prevention concentration (MPC). The fraction of time within 24 h that the free drug concentration was within the MSW (fTMSW) and the fraction of time that the free drug concentration was above the MPC (fT>MPC) in both plasma and epithelial lining fluid (ELF) were determined from simulations of 10 000 profiles. The joint PTA was used to derive a joint cumulative fraction of response (CFR).

RESULTS: All isolates were resistant to ceftazidime/avibactam or aztreonam. Combining aztreonam and avibactam or ceftazidime/avibactam resulted in synergistic bactericidal activities against all isolates. Synergism was primarily due to the aztreonam/avibactam combination. For aztreonam/avibactam dosing regimens evaluated in clinical trials, fT>MPC values were >90% and >80%, whereas fTMSW measures were <10% and <20% in plasma and ELF, respectively. The CFR was 100% for aztreonam/avibactam against the collection of clinical isolates.

CONCLUSIONS: Effective antimicrobial combination optimized the PD parameters measuring selection for emergent mutants by increasing fT>MPC and reducing fTMSW.

PMID:34383928 | DOI:10.1093/jac/dkab292