Tag: pubmed

JAMA Surg. 2022 May 25. doi: 10.1001/jamasurg.2022.1554. Online ahead of print.

ABSTRACT

IMPORTANCE: For adults with appendicitis, several randomized clinical trials have demonstrated that antibiotics are an effective alternative to appendectomy. However, it remains unknown how the characteristics of patients in such trials compare with those of patients who select their treatment and whether outcomes differ.

OBJECTIVE: To compare participants in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial (RCT) with a parallel cohort study of participants who declined randomization and self-selected treatment.

DESIGN, SETTING, AND PARTICIPANTS: The CODA trial was conducted in 25 US medical centers. Participants were enrolled between May 3, 2016, and February 5, 2020; all participants were eligible for at least 1 year of follow-up, with all follow-up ending in 2021. The randomized cohort included 1094 adults with appendicitis; the self-selection cohort included patients who declined participation in the randomized group, of whom 253 selected appendectomy and 257 selected antibiotics. In this secondary analysis, characteristics and outcomes in both self-selection and randomized cohorts are described with an exploratory analysis of cohort status and receipt of appendectomy.

INTERVENTIONS: Appendectomy vs antibiotics.

MAIN OUTCOMES AND MEASURES: Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment.

RESULTS: Clinical characteristics were similar across the self-selection cohort (510 patients; mean age, 35.8 years [95% CI, 34.5-37.1]; 218 female [43%; 95% CI, 39%-47%]) and the randomized group (1094 patients; mean age, 38.2 years [95% CI, 37.4-39.0]; 386 female [35%; 95% CI, 33%-38%]). Compared with the randomized group, those in the self-selection cohort were less often Spanish speaking (n = 99 [19%; 95% CI, 16%-23%] vs n = 336 [31%; 95% CI, 28%-34%]), reported more formal education (some college or more, n = 355 [72%; 95% CI, 68%-76%] vs n = 674 [63%; 95% CI, 60%-65%]), and more often had commercial insurance (n = 259 [53%; 95% CI, 48%-57%] vs n = 486 [45%; 95% CI, 42%-48%]). Most outcomes were similar between the self-selection and randomized cohorts. The number of patients undergoing appendectomy by 30 days was 38 (15.3%; 95% CI, 10.7%-19.7%) among those selecting antibiotics and 155 (19.2%; 95% CI, 15.9%-22.5%) in those who were randomized to antibiotics (difference, 3.9%; 95% CI, -1.7% to 9.5%). Differences in the rate of appendectomy were primarily observed in the non-appendicolith subgroup.

CONCLUSIONS AND RELEVANCE: This secondary analysis of the CODA RCT found substantially similar outcomes across the randomized and self-selection cohorts, suggesting that the randomized trial results are generalizable to the community at large.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02800785.

PMID:35612859 | DOI:10.1001/jamasurg.2022.1554

Adv Exp Med Biol. 2022;1373:209-227. doi: 10.1007/978-3-030-96881-6_11.

ABSTRACT

A complex disease such as periodontitis is the sum of environmental and genetic effects. The personal genetic constitution interacts with the effects of internal and external risk factors like smoking, oral hygiene, malnutrition, emotional stress, and age. Accordingly, individuals who live in the same environmental context and share comparable lifestyle habits have different disease risks. Genetic research offers the identification of DNA sequence variants that have a causal role in disease etiology and allows the identification of disease relevant immune and metabolic pathways that contribute to disease susceptibility and pathogenesis in specific situations. Real advances have been made in genetic medical research in the last years. Starting from candidate gene association studies, new approaches were employed that have expanded the study design of genomewide association studies to genomewide meta-analyses and gene x environment interaction studies. Cost efficient whole-exome and whole-genome sequencing of patients with rare severe forms of periodontitis has the potential to identify genes and pathways with a direct role in the pathogenesis of common forms. In parallel, animal models were developed that use genetically highly diverse mouse lines to identify risk genes of human diseases. This chapter presents the main studies and the identified susceptibility genes that have clear statistical evidence. In addition, it describes pioneering studies that used advanced methods in experimental dental research, opening up new avenues of research. Although the knowledge of the genetic architecture of periodontitis is still in its infancy, genetic research is building the basis for future works with the potential to advance dental medicine in ways that will determine the various causes of periodontal diseases. This knowledge may eventually allow making predictions about disease risk for individual patients and leading to diagnosis and treatments that do not treat the symptoms but heal the disease.

PMID:35612800 | DOI:10.1007/978-3-030-96881-6_11

Methods Mol Biol. 2022;2456:319-338. doi: 10.1007/978-1-0716-2124-0_22.

ABSTRACT

Constant improvements in mass spectrometry technologies and laboratory workflows have enabled the proteomics investigation of biological samples of growing complexity. Microbiomes represent such complex samples for which metaproteomics analyses are becoming increasingly popular. Metaproteomics experimental procedures create large amounts of data from which biologically relevant signal must be efficiently extracted to draw meaningful conclusions. Such a data processing requires appropriate bioinformatics tools specifically developed for, or capable of handling metaproteomics data. In this chapter, we outline current and novel tools that can perform the most commonly used steps in the analysis of cutting-edge metaproteomics data, such as peptide and protein identification and quantification, as well as data normalization, imputation, mining, and visualization. We also provide details about the experimental setups in which these tools should be used.

PMID:35612752 | DOI:10.1007/978-1-0716-2124-0_22

Interdiscip Sci. 2022 May 25. doi: 10.1007/s12539-022-00527-x. Online ahead of print.

NO ABSTRACT

PMID:35612716 | DOI:10.1007/s12539-022-00527-x

Skeletal Radiol. 2022 May 25. doi: 10.1007/s00256-022-04078-6. Online ahead of print.

ABSTRACT

OBJECTIVE: Bone marrow biopsy complications are rare. Our aim is to study the association of improper palpation-guided iliac biopsy tract with complications.

MATERIALS AND METHODS: This is a retrospective study of adult patients who underwent iliac bone marrow biopsy without image guidance at our hospital from January 2019 to January 2021, and have cross-sectional radiologic imaging of the pelvis within 30 days following the procedure. Electronic health records were reviewed for clinical data. Two radiologists reviewed images of the pelvis for assessment of biopsy tract and complications.

RESULTS: A total of 443 procedures were included in 309 patients, mean age 53.4 ± 18.1 years, 112 females (36.2%). In addition, 332 tracts were proper (75%), 97 improper (22%), and 14 unidentified (3%). All 11 complications occurred in procedures with improper tracts; nine bleeding, one fracture, and one facet joint injury. Improper tract was significantly associated with complications (p < .001). There was no statistically significant association between platelet count, international normalized ratio, antiplatelet use and anticoagulant use, and presence of complications (p > .05). Body mass index and subcutaneous fat thickness overlying posterior superior iliac spine were not associated with improper tract (p > .05). Procedures performed by providers with ≤ 12 months’ experience were significantly associated with improper tract (p < .001) and hence associated with complications (p = .007).

CONCLUSION: Improper tracts were common in palpation-guided iliac bone marrow biopsy and significantly associated with complications. No complications were encountered in proper tract procedures. Procedures performed by providers with ≤ 12 months’ experience were significantly associated with improper tract and complications.

PMID:35612650 | DOI:10.1007/s00256-022-04078-6

Ann Nucl Med. 2022 May 25. doi: 10.1007/s12149-022-01752-6. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aimed to determine the correlation of [⁶⁸Ga]Ga-NODAGA^ZOL uptake in atherosclerotic plaques and the cardiovascular risk profile of patients imaged with positron emission tomography (PET), wherein quantification of uptake was determined by atherosclerotic plaque maximum target-to-background ratio (TBRmax). We also correlated uptake with a history of cardiovascular events.

METHODS: We included patients who underwent PET/CT imaging post-injection of [⁶⁸Ga] Ga-NODAGA^ZOL. We documented the number of atherosclerotic plaques found in the major arteries on CT and the cardiovascular risks in each patient. We quantified the intensity of tracer uptake in atherosclerotic plaque in the major arteries using the maximum standardized uptake value (SUVmax). The SUVmax of the most tracer-avid plaque was documented as representative of the individual arterial bed. We determined background vascular tracer activity using the mean standardized uptake value (SUVmean) obtained from the lumen of the superior vena cava. The maximum target-to-background ratio (TBRmax) was calculated as a ratio of the SUVmax to the SUVmean. The TBRmax was correlated to the number of atherogenic risk factors and history of cardiovascular events.

RESULTS: Thirty-four patients (M: F 31:3; mean age ± SD: 63 ± 10.01 years) with ≥ 2 cardiovascular risk factors were included. Statistically significant correlation between TBRmax and the number of cardiovascular risk factors was noted in the right carotid (r = 0.50; p < 0.05); left carotid (r = 0. 649; p < 0.05); ascending aorta (r = 0.375; p < 0.05); aortic arch (r = 0.483; p < 0.05); thoracic aorta (r = 0.644; p < 0.05); left femoral (r = 0.552; p < 0.05) and right femoral arteries (r = 0.533; p < 0.05). TBRmax also demonstrated a positive correlation to history of cardiovascular event in the right carotid (U = 26.00; p < 0.05); left carotid (U = 11.00; p < 0.05); ascending aorta (U = 49.00; p < 0.05); aortic arch (U = 37.00; p < 0.05); thoracic aorta (U = 16.00; p < 0.05); left common iliac (U = 49.500; p < 0.05), right common iliac (U = 43.00; p < 0.05), left femoral (U = 40.500; p < 0.05) and right femoral (U = 37.500; p < 0.05).

CONCLUSION: In this cohort of patients, a positive correlation was noted between atherosclerotic plaque uptake of [⁶⁸Ga]Ga-NODAGA^ZOL and the number of atherogenic risk factors which translates to the risk of atherosclerosis and cardiovascular risk factors.

PMID:35612698 | DOI:10.1007/s12149-022-01752-6

Environ Monit Assess. 2022 May 25;194(7):456. doi: 10.1007/s10661-022-10107-7.

ABSTRACT

Emissions of gaseous elemental mercury (GEM or Hg⁰) from different sources in urban areas are important subjects for environmental investigations. In this study, atmospheric Hg measurements were conducted to investigate air pollution in the urban environment by carrying out several mobile surveys in Mexico City. This work presents atmospheric concentrations of GEM in terms of diurnal variation trends and comparisons with criteria for pollutant concentrations such as CO, SO₂, NO₂, PM_2.5, and PM₁₀. The concentration of GEM was measured during the pre-rainy period by using a high-resolution active air sampler, the Lumex RA 915 M mercury analyzer. In comparison with those for other cities worldwide, the GEM concentrations were similar or slightly elevated, and they ranged from 0.20 to 30.23 ng m^-3. However, the GEM concentration was significantly lower than those in contaminated areas, such as fluorescent lamp factory locations and gold mining zones. The GEM concentrations recorded in Mexico City did not exceed the WHO atmospheric limit of 200 ng m^-3. We performed statistical correlation analysis which suggests equivalent sources between Hg and other atmospheric pollutants, mainly NO₂ and SO₂, emitted from urban combustion and industrial plants. The atmospheric Hg emissions are basically controlled by sunlight radiation, as well as having a direct relationship with meteorological parameters. The area of the city studied herein is characterized by high traffic density, cement production, and municipal solid waste (MSW) treatment, which constantly release GEM into the atmosphere. In this study, we included the simulation with the HYSPLIT dispersion model from three potential areas of GEM release. Emissions from industrial corridors and volcanic plumes localized outside the urban area contribute to the pollution of Mexico City and mainly affect the northern area during specific periods and climate conditions. Using the USEPA model, we assessed the human health risk resulting from exposure to inhaled GEM among residents of Mexico City. The results of the health risk assessment indicated no significant noncarcinogenic risk (hazard quotient (HQ) < 1) or consequent adverse effects for children and adults living in the sampling area over the study period. GEM emissions inventory data is necessary to improve our knowledge about the Hg contribution and effect in urban megacity areas with the objective to develop public safe policy and implementing the Minamata Convention.

PMID:35612636 | DOI:10.1007/s10661-022-10107-7

Interact J Med Res. 2022 May 25. doi: 10.2196/38542. Online ahead of print.

ABSTRACT

BACKGROUND: Bacopa monnieri, a herb used extensively, has shown neuroprotective effects in animal and invitro studies; human studies on patients with Alzheimer’s Disease (AD) have been inconclusive.

OBJECTIVE: The primary objective was to determine the clinical efficacy and safety of Bacopa monnieri (Brahmi) in persons with mild, moderate or severe dementia due to Alzheimer’s disease and Mild Cognitive Impairment-Alzheimer’s disease (MCI-AD).

METHODS: We searched PubMed, Excerpta Medica dataBASE (EMBASE), Cochrane library, clinical trial registries (WHO, Aus-New Zealand, US and SA clinical registry), metaRegister of Controlled Trials (mRCT) and Cumulative Index to Nursing and Allied Health Literature (CINAHL). We intended to include ll randomized and quasi-randomized controlled trials that compared Bacopa monnieri, its extract or active ingredients (at any dosage) with placebo or one of the Cholinesterase inhibitors among adults with dementia due to AD and MCI-AD.

RESULTS: Our comprehensive search yielded five eligible studies. Three studies used Bacopa in combination with herbal extracts while remaining two used Bacopa extracts only. Two studies compared Bacopa with Donepezil while others used placebo as control. There was considerable variation in dose of bacopa used (ranging between 125 mg to 500 mg twice daily) and heterogeneity in treatment durations, follow up and outcomes. The major outcomes were Mini-mental status examination reported in three trials, Alzheimer’s disease assessment scale – Cognitive (ADAS-Cog) in one and a battery of cognitive tests in two studies. Using Cochrane risk of bias tool, overall, we judged all five studies to be at high risk of bias. While all studies reported statistically significant difference between Bacopa and comparator in at least one outcome, we rated overall quality of evidence for ADAS-Cog, PGI memory scale, Mini-Mental State Examination (MMSE) and Weschler memory scale to be very low because of downgrading by two levels for high risk of bias and one more level for impreciseness consequent to small sample sizes and wide confidence intervals.

CONCLUSIONS: There is no difference between Bacopa and placebo or Donepezil in treatment of AD based on very low certainty evidence. No major safety issues were reported in the included trials. Future Randomized Controlled Trials (RCTs) must aim to recruit more participants and report clinically meaningful outcomes.

CLINICALTRIAL: Crd42020169421.

PMID:35612544 | DOI:10.2196/38542

Ann Plast Surg. 2022 Jun 1;88(6):606-611. doi: 10.1097/SAP.0000000000003111. Epub 2022 Feb 18.

ABSTRACT

BACKGROUND: Fifty percent of Asians are born without a supratarsal fold (also called single eyelid), and double eyelid blepharoplasty is one of the most commonly performed and most popular facial cosmetic surgeries in the Asian population. However, patients with single eyelid frequently present with concomitant mild blepharoptosis (degree of ptosis, ≤2 mm), which often fails to cause the attention of surgeons and misses correction.

METHODS: A retrospective study of all patients who underwent double eyelid blepharoplasty and blepharoptosis correction simultaneously with the modified levator aponeurosis plication technique was performed from June of 2017 to June of 2020.

RESULTS: A total of 108 patients (155 eyelids) underwent double eyelid blepharoplasty and blepharoptosis correction simultaneously with the modified levator aponeurosis plication technique and were enrolled in the study. The average follow-up period was 11.8 ± 4.5 months. There was a statistically significant difference between the preoperative margin reflex distance 1 (MRD1) and postoperative MRD1 (2.93 ± 0.37 vs 4.21 ± 0.39 mm, P = 0.000), and the mean MRD1 improvement was 1.28 ± 0.50 mm. Sufficient correction was obtained in 148 eyelids (95.5%), whereas undercorrection was observed in 5 eyelids (3.2%) and overcorrection was observed in 2 eyelids (1.3%). One hundred two patients (94.4%) were completely satisfied with the final result.All patients had smooth and elegant upper eyelid margin curve, and no patients complained of distortion of the eyelid margin contour and foreign body sensation.There were no cases of hematoma, infection, suture exposure, corneal abrasion, and keratitis in any patient.

CONCLUSIONS: This modified levator aponeurosis plication introduced in this study is a simple and effective method for creating double-eyelid crease and correcting mild blepharoptosis simultaneously, and provides a satisfactory outcome. As such, we recommend this method in treating patients with both single eyelid and mild blepharoptosis.

PMID:35612534 | DOI:10.1097/SAP.0000000000003111

J Biopharm Stat. 2022 May 25:1-7. doi: 10.1080/10543406.2022.2080691. Online ahead of print.

ABSTRACT

When applying group-sequential designs in clinical trials with normally distributed outcomes, approximate critical values are often applied. Here, normally distributed test statistics are assumed which, however, are in fact t-distributed. For small sample sizes, the approximation may lead to a serious inflation of the type I error rate. Recently, a method for computing the exact critical boundaries assuring type I error rate control was proposed and the critical boundaries for Pocock- and O’Brien-Fleming-like group-sequential designs were provided. For designs with one interim analysis, we present six alternative designs, which also control the type I error rate and in addition allow flexible design modifications. We compare the characteristics of these 6 two-stage designs. It is shown that considerable sample size savings can be achieved by including futility stopping and by optimizing the designs. Therefore, for clinical trials with small sample sizes as, for example, in the area of rare diseases, optimal two-stage designs with futility stopping may be a valuable alternative to classical group-sequential designs.

PMID:35612521 | DOI:10.1080/10543406.2022.2080691