Categories
Nevin Manimala Statistics

Diagnostic efficacy and safety of radial probe endobronchial ultrasound-guided transbronchial needle aspiration for adjacent lesions in segmental or subsegmental bronchi: a single-center retrospective study

BMC Pulm Med. 2023 Dec 4;23(1):485. doi: 10.1186/s12890-023-02781-1.

ABSTRACT

BACKGROUND: Peripheral lung lesions can be sampled using various techniques, including computer tomography-guided transthoracic needle aspiration, electromagnetic navigation bronchoscopy, virtual navigation bronchoscopy, and radial probe endobronchial ultrasound transbronchial lung biopsy. Mediastinal lesions can be sampled using techniques like convex probe endobronchial ultrasound-guided transbronchial needle aspiration (CEBUS-TBNA) and endoscopic ultrasound-fine-needle aspiration. However, effective, safe techniques for lesions adjacent to the segmental or subsegmental bronchi are lacking. Herein, we retrospectively evaluated the diagnostic yield and safety of radial probe endobronchial ultrasound-assisted transbronchial needle aspiration (REBUS-TBNA) for lesions adjacent to the segmental bronchi, and explored the factors related to diagnostic yield.

METHODS: We retrospectively analyzed the diagnostic yield and safety of REBUS-TBNA cases performed in our department from January 2019 to December 2022. Observation group patients had undergone REBUS-TBNA for lesions adjacent to the segmental bronchi; control group patients had undergone CEBUS-TBNA for mediastinal or hilar lesions. Patient characteristics and lesion sizes, diagnostic yield, adverse events, and relations between diagnostic yield and clinical characteristics were analyzed.

RESULTS: There were not statistically significant between-group differences in sex, age, diagnostic yield, or rate of adverse events. The observation group (n = 25; 17 male, 8 female) had a mean age of 64.76 ± 10.75 years. The average lesion size was 4.66 ± 1.07 cm, and lesions were predominantly in the upper lobes (80%). REBUS-TBNA diagnostic yield was 84%, with no adverse events reported. Diagnostic yield was not associated with lesion size or extent of bronchial stenosis; however, it was positively correlated with number of punctures. Patients with > 3 punctures had a significantly higher diagnostic yield than those with ≤ 3 punctures.

CONCLUSIONS: REBUS-TBNA is a safe, effective diagnostic technique, particularly for lesions adjacent to the segmental or subsegmental bronchi of the upper lobe. Performing more than three punctures during the procedure improves the diagnostic yield. Larger-scale studies are warranted to confirm these results, and to further explore the clinical value of REBUS-TBNA.

PMID:38049784 | DOI:10.1186/s12890-023-02781-1

Categories
Nevin Manimala Statistics

Efficacy and Safety of Cilostazol in Mild Cognitive Impairment: A Randomized Clinical Trial

JAMA Netw Open. 2023 Dec 1;6(12):e2344938. doi: 10.1001/jamanetworkopen.2023.44938.

ABSTRACT

IMPORTANCE: Recent evidence indicates the efficacy of β-amyloid immunotherapy for the treatment of Alzheimer disease, highlighting the need to promote β-amyloid removal from the brain. Cilostazol, a selective type 3 phosphodiesterase inhibitor, promotes such clearance by facilitating intramural periarterial drainage.

OBJECTIVE: To determine the safety and efficacy of cilostazol in mild cognitive impairment.

DESIGN, SETTING, AND PARTICIPANTS: The COMCID trial (A Trial of Cilostazol for Prevention of Conversion from Mild Cognitive Impairment to Dementia) was an investigator-initiated, double-blind, phase 2 randomized clinical trial. Adult participants were registered between May 25, 2015, and March 31, 2018, and received placebo or cilostazol for up to 96 weeks. Participants were treated in the National Cerebral and Cardiovascular Center and 14 other regional core hospitals in Japan. Patients with mild cognitive impairment with Mini-Mental State Examination (MMSE) scores of 22 to 28 points (on a scale of 0 to 30, with lower scores indicating greater cognitive impairment) and Clinical Dementia Rating scores of 0.5 points (on a scale of 0, 0.5, 1, 2, and 3, with higher scores indicating more severe dementia) were enrolled. The data were analyzed from May 1, 2020, to December 1, 2020.

INTERVENTIONS: The participants were treated with placebo, 1 tablet twice daily, or cilostazol, 50 mg twice daily, for up to 96 weeks.

MAIN OUTCOMES AND MEASURES: The primary end point was the change in the total MMSE score from baseline to the final observation. Safety analyses included all adverse events.

RESULTS: The full analysis set included 159 patients (66 [41.5%] male; mean [SD] age, 75.6 [5.2] years) who received placebo or cilostazol at least once. There was no statistically significant difference between the placebo and cilostazol groups for the primary outcome. The least-squares mean (SE) changes in the MMSE scores among patients receiving placebo were -0.1 (0.3) at the 24-week visit, -0.8 (0.3) at 48 weeks, -1.2 (0.4) at 72 weeks, and -1.3 (0.4) at 96 weeks. Among those receiving cilostazol, the least-squares mean (SE) changes in MMSE scores were -0.6 (0.3) at 24 weeks, -1.0 (0.3) at 48 weeks, -1.1 (0.4) at 72 weeks, and -1.8 (0.4) at 96 weeks. Two patients (2.5%) in the placebo group and 3 patients (3.8%) in the cilostazol group withdrew owing to adverse effects. There was 1 case of subdural hematoma in the cilostazol group, which may have been related to the cilostazol treatment; the patient was successfully treated surgically.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, cilostazol was well tolerated, although it did not prevent cognitive decline. The efficacy of cilostazol should be tested in future trials.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02491268.

PMID:38048134 | DOI:10.1001/jamanetworkopen.2023.44938

Categories
Nevin Manimala Statistics

Mortality and Morbidity Among Individuals With Hypertension Receiving a Diuretic, ACE Inhibitor, or Calcium Channel Blocker: A Secondary Analysis of a Randomized Clinical Trial

JAMA Netw Open. 2023 Dec 1;6(12):e2344998. doi: 10.1001/jamanetworkopen.2023.44998.

ABSTRACT

IMPORTANCE: The long-term relative risk of antihypertensive treatments with regard to mortality and morbidity is not well understood.

OBJECTIVE: To determine the long-term posttrial risk of primary and secondary outcomes among trial participants who were randomized to either a thiazide-type diuretic, calcium channel blocker (CCB), or angiotensin-converting enzyme (ACE) inhibitor with up to 23 years of follow-up.

DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a multicenter randomized, double-blind, active-controlled clinical trial, followed up with participants aged 55 years or older with a diagnosis of hypertension and at least 1 other coronary heart disease risk factor for up to 23 years, from February 23, 1994, to December 31, 2017. Trial participants were linked with administrative databases for posttrial mortality (N = 32 804) and morbidity outcomes (n = 22 754). Statistical analysis was performed from January 2022 to October 2023.

INTERVENTIONS: Participants were randomly assigned to receive a thiazide-type diuretic (n = 15 002), a CCB (n = 8898), or an ACE inhibitor (n = 8904) for planned in-trial follow-up of approximately 4 to 8 years and posttrial passive follow-up for up to 23 years.

MAIN OUTCOMES AND MEASURES: The primary end point was mortality due to cardiovascular disease (CVD). Secondary outcomes included all-cause mortality, combined fatal and nonfatal (morbidity) CVD, and both mortality and morbidity for coronary heart disease, stroke, heart failure, end-stage renal disease, and cancer.

RESULTS: A total of 32 804 participants (mean [SD] age, 66.9 [7.7] years; 17 411 men [53.1%]; and 11 772 Black participants [35.9%]) were followed up for all-cause mortality and a subgroup of 22 754 participants (mean [SD] age, 68.7 [7.2] years; 12 772 women [56.1%]; and 8199 Black participants [36.0%]) were followed up for fatal or nonfatal CVD through 2017 (mean [SD] follow-up, 13.7 [6.7] years; maximum follow-up, 23.9 years). Cardiovascular disease mortality rates per 100 persons were 23.7, 21.6, and 23.8 in the diuretic, CCB, and ACE inhibitor groups, respectively, at 23 years after randomization (adjusted hazard ratio [AHR], 0.97 [95% CI, 0.89-1.05] for CCB vs diuretic; AHR, 1.06 [95% CI, 0.97-1.15] for ACE inhibitor vs diuretic). The long-term risks of most secondary outcomes were similar among the 3 groups. Compared with the diuretic group, the ACE inhibitor group had a 19% increased risk of stroke mortality (AHR, 1.19 [95% CI, 1.03-1.37]) and an 11% increased risk of combined fatal and nonfatal hospitalized stroke (AHR, 1.11 [95% CI, 1.03-1.20]).

CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial in an adult population with hypertension and coronary heart disease risk factors, CVD mortality was similar between all 3 groups. ACE inhibitors increased the risk of stroke outcomes by 11% compared with diuretics, and this effect persisted well beyond the trial period.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00000542.

PMID:38048133 | DOI:10.1001/jamanetworkopen.2023.44998

Categories
Nevin Manimala Statistics

Exposure to Agent Orange and Hepatocellular Carcinoma Among US Military Personnel

JAMA Netw Open. 2023 Dec 1;6(12):e2346380. doi: 10.1001/jamanetworkopen.2023.46380.

ABSTRACT

IMPORTANCE: Hepatocellular carcinoma (HCC) and its mortality are on the rise. Viral hepatitis and alcohol are leading risk factors; however, other risk factors among veterans are less defined, including Agent Orange (AO), an herbicide linked to several cancers.

OBJECTIVE: To assess the association of AO exposure and HCC in a national cohort of Vietnam veterans.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included Vietnam veterans who served between 1966 and 1975, were male, were older than 18 years at the time of deployment, and had established follow-up in the Veterans Affairs (VA) between 2000 and 2019. Veterans with AO exposure were identified in the disability data via validated clinical surveys. Relevant clinical risk factors for cirrhosis and HCC were collected. Patients were stratified based on cirrhosis status, as defined by consecutive diagnosis found by documented International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision scores or calculated Fibrosis-4 scores. Data were collected from January 1, 2019, to December 31, 2020, and analyzed from December 2020 to October 2023.

MAIN OUTCOME AND MEASURES: Incident HCC was the primary outcome. AO and HCC association was estimated using a multivariable Cox regression analysis, with death and liver transplant as competing events.

RESULTS: Of the 296 505 eligible veterans (222 545 [75.1%] White individuals and 44 342 [15.0%] Black individuals), 170 090 (57%) had AO exposure (mean [SD] age, 21.62 [3.49] years; 131 552 White individuals [83.2%] and 22 767 Black individuals [14.4%]) and 35 877 (12.1%) had cirrhosis. Veterans who were not exposed to AO were more likely to smoke (109 689 of 126 413 [86.8%] vs 146 061 of 170 090 [85.9%]); use alcohol (54 147 of 126 413 [42.8%] vs 71 951 of 170 090 [42.3%]) and have viral hepatitis (47 722 of 126 413 [37.8%] vs 58 942 of 170 090 [34.7%]). In a multivariable competing risk model, AO exposure was not associated with HCC. Among veterans with cirrhosis, self-identification as Hispanic individuals (aHR, 1.51; 95% CI, 1.30-1.75; P <.001) or Black individuals (aHR, 1.18; 95% CI, 1.05-1.32; P = .004), and having a diagnosis of viral hepatitis (aHR, 3.71; 95% CI, 3.26-4.24; P <.001), alcohol-associated liver disease (aHR, 1.32; 95% CI, 1.19-1.46; P <.001), and nonalcoholic fatty liver disease (NAFLD) (aHR, 1.92; 95% CI, 1.72-2.15; P <.001) were associated with HCC. Among veterans without cirrhosis, hypertension (aHR, 1.63; 95% CI, 1.23-2.15; P <.001) and diabetes (aHR, 1.52; 95% CI, 1.13-2.05; P = .005) were also associated with HCC. Early smoking and alcohol use were significant risk factors for HCC.

CONCLUSIONS AND RELEVANCE: In this large nationwide cohort study of Vietnam veterans, AO exposure was not associated with HCC. Smoking, alcohol, viral hepatitis, and NAFLD were the most important clinical risk factors for HCC.

PMID:38048128 | DOI:10.1001/jamanetworkopen.2023.46380

Categories
Nevin Manimala Statistics

Clinical Relevance of Sternal Foramina: A Morphometric Study

Clin Ter. 2023 Nov-Dec;174(6):503-508. doi: 10.7417/CT.2023.5017.

ABSTRACT

OBJECTIVES: The present study aimed at determining the incidence of sternal foramina in adult dry bones of North Indian descent. We also aimed to determine the number, precise location of the sternal foramina with a standard reference point which might have considerable importance with regard to procedures involving sternal puncture.

METHODS: This cross sectional descriptive study was conducted on 72 dry adult human sternums. Various measurements in relation to the sternal foramina were taken with a non-stretchable measuring tape and digital vernier calliper and expressed as: [A]-total sternal length, [B]-distance between the jugular notches to the foramen, [C]-distance between the angle of Louis to the foramen and [D]-distance of the foramen from the mid sternal plane. Statistical analysis was performed with Microsoft Excel version 2019. A p-value of <0.05 was considered significant.

RESULTS: We found 6.94% (5 out of 72 sternums) incidence of sternal foramina which corroborates well with the existing literature. Mean sternal length was 127.7 ± 09 mm. The mean distance of the foramina from suprasternal notch, sternal angle and from the median plane were 118.12 ± 0.3 mm, 116.7 mm and 2.4 mm respectively. Incidence of sternal foramina was almost similar to previously reported studies.

CONCLUSIONS: The precise knowledge about the expected location of sternal foramina is imperative to avoid intra-thoracic visceral injury during commonly performed acupuncture needle insertion and while doing bone marrow aspiration for diagnostic evaluation.

PMID:38048113 | DOI:10.7417/CT.2023.5017

Categories
Nevin Manimala Statistics

Montgomery Salivary Bypass Tube vs Self-Expandable Metal Stents for the treatment of esophageal strictures after total laryngectomy: a crossover study

Clin Ter. 2023 Nov-Dec;174(6):478-482. doi: 10.7417/CT.2023.5012.

ABSTRACT

OBJECTIVES: Dysphagia affects 16% of patients undergoing total laryngectomy; of these, a third is due to pharyngoesophageal stenosis. Currently, the treatment is cyclic dilation of the stricture and Montgomery Salivary Bypass Tube (MSBT) application. The aim of this study is to assess whether using Self-Expandable Metal Stent (SEMS) may give better results after a non-durable response to repeated dilatation and application of MSBT.

MATERIALS AND METHODS: We verified whether using SEMS after at least 3 cyclic dilations and application of MSBT results in a longer dysphagia-free time in laryngectomized patients with pharyngolesopha-geal stenosis. Secondary outcomes were the duration of the procedures, radiation exposure and complications.

RESULTS: We enrolled 6 patients with a median age of 65 years (QR 62.5 – 75.75), of which 50% had undergone radiotherapy. Friedman’s test for the duration of the dysphagia-free period did not show a statistically significant difference between the two groups (Friedman chi-squared = 2.6667, df = 1, p-value = 0.1025). The time required to implant the MSBT was significantly less than that required to implant the SEMS (Friedman chi-squared = 6, df = 1, p-value = 0.01431). Radiation exposure was absent for MSBT, while SEMS implant required an exposure to X-rays during the procedure and after 48 hours for placement verification. Two patients experienced short-term complications after SEMS implantation and one after two weeks from MSBT implantation; none of them had any health consequences.

CONCLUSION: In patients who are already undergoing cyclic dilations and application of MSBT, switching to SEMS is not beneficial. Furthermore, MSBT has a significantly shorter implant procedure, does not expose the patient to X-rays, and, in the absence of complications, has a longer duration before removal.

PMID:38048108 | DOI:10.7417/CT.2023.5012

Categories
Nevin Manimala Statistics

Association between Noise and Cardiovascular Disease in a Nationwide U.S. Prospective Cohort Study of Women Followed from 1988 to 2018

Environ Health Perspect. 2023 Dec;131(12):127005. doi: 10.1289/EHP12906. Epub 2023 Dec 4.

ABSTRACT

BACKGROUND: Long-term noise exposure is associated with cardiovascular disease (CVD), including acute cardiovascular events such as myocardial infarction and stroke. However, longitudinal cohort studies in the U.S. of long-term noise and CVD are almost exclusively from Europe and few modeled nighttime noise, when an individual is likely at home or asleep, separately from daytime noise. We aimed to examine the prospective association of outdoor long-term nighttime and daytime noise from anthropogenic sources with incident CVD using a U.S.-based, nationwide cohort of women.

METHODS: We linked L50 nighttime and L50 daytime anthropogenic modeled noise estimates from a U.S. National Parks Service model (L50: sound pressure levels exceeded 50 percent of the time) to geocoded residential addresses of 114,116 participants in the Nurses’ Health Study. We used time-varying Cox proportional hazards models to estimate risk of incident CVD, coronary heart disease (CHD), and stroke associated with long-term average (14-y measurement period) noise exposure, adjusted for potential individual- and area-level confounders and CVD risk factors (1988-2018; biennial residential address updates; monthly CVD updates). We assessed effect modification by population density, region, air pollution, vegetation cover, and neighborhood socioeconomic status, and explored mediation by self-reported average nightly sleep duration.

RESULTS: Over 2,548,927 person-years, there were 10,331 incident CVD events. In fully adjusted models, the hazard ratios for each interquartile range increase in L50 nighttime noise (3.67 dBA) and L50 daytime noise (4.35 dBA), respectively, were 1.04 (95% CI: 1.02, 1.06) and 1.04 (95% CI: 1.02, 1.07). Associations for total energy-equivalent noise level (Leq) measures were stronger than for the anthropogenic statistical L50 noise measures. Similar associations were observed for CHD and stroke. Interaction analyses suggested that associations of L50 nighttime and L50 daytime noise with CVD did not differ by prespecified effect modifiers. We found no evidence that inadequate sleep (<5 h/night) mediated associations of L50 nighttime noise and CVD.

DISCUSSION: Outdoor L50 anthropogenic nighttime and daytime noise at the residential address was associated with a small increase in CVD risk in a cohort of adult female nurses. https://doi.org/10.1289/EHP12906.

PMID:38048103 | DOI:10.1289/EHP12906

Categories
Nevin Manimala Statistics

Metal Concentrations in E-Cigarette Aerosol Samples: A Comparison by Device Type and Flavor

Environ Health Perspect. 2023 Dec;131(12):127004. doi: 10.1289/EHP11921. Epub 2023 Dec 4.

ABSTRACT

BACKGROUND: The rapid evolution of electronic cigarette (e-cigarette) products warrants surveillance of the differences in exposure across device types-modifiable devices (MODs), cartridge (“pod”)-containing devices (PODs), disposable PODs (d-PODs)-and flavors of the products available on the market.

OBJECTIVE: This study aimed to measure and compare metal aerosol concentrations by device type and common flavors.

METHODS: We collected aerosol from 104 MODs, 67 PODs (four brands: JUUL, Bo, Suorin, PHIX), and 23 d-PODs (three brands: ZPOD, Bidi, Stig) via droplet deposition in a series of conical pipette tips. Metals and metalloids [aluminum (Al), arsenic (As), cobalt (Co), chromium (Cr), copper (Cu), iron (Fe), manganese (Mn), nickel (Ni), lead (Pb), antimony (Sb), tin (Sn), and zinc (Zn)] were measured using inductively coupled plasma mass spectrometry (ICP-MS), results were log-transformed for statistical analysis, and concentrations are reported in aerosol units (mg/m3).

RESULTS: Of the 12 elements analyzed, concentrations were statistically significantly higher in MOD devices, except for Co and Ni, which were higher in PODs and d-PODs. Of the POD brands analyzed, PHIX had the highest median concentrations among four metals (Al, Ni, Pb, and Sn) compared to the rest of the POD brands. According to POD flavor, seven metals were three to seven orders of magnitude higher in tobacco-flavored aerosol compared to those in mint and mango flavors. Among the d-POD brands, concentrations of four metals (Al, Cu, Ni, and Pb) were higher in the ZPOD brand than in Bidi Stick and Stig devices. According to d-POD flavor, only Cr concentrations were found to be statistically significantly higher in mint than tobacco-flavored d-PODs.

DISCUSSION: We observed wide variability in aerosol metal concentrations within and between the different e-cigarette device types, brands, and flavors. Overall, MOD devices generated aerosols with higher metal concentrations than PODs and d-PODs, and tobacco-flavored aerosols contained the highest metal concentrations. Continued research is needed to evaluate additional factors (i.e., nicotine type) that contribute to metal exposure from new and emerging e-cigarette devices in order to inform policy. https://doi.org/10.1289/EHP11921.

PMID:38048100 | DOI:10.1289/EHP11921

Categories
Nevin Manimala Statistics

MESPool: Molecular Edge Shrinkage Pooling for hierarchical molecular representation learning and property prediction

Brief Bioinform. 2023 Nov 22;25(1):bbad423. doi: 10.1093/bib/bbad423.

ABSTRACT

Identifying task-relevant structures is important for molecular property prediction. In a graph neural network (GNN), graph pooling can group nodes and hierarchically represent the molecular graph. However, previous pooling methods either drop out node information or lose the connection of the original graph; therefore, it is difficult to identify continuous subtructures. Importantly, they lacked interpretability on molecular graphs. To this end, we proposed a novel Molecular Edge Shrinkage Pooling (MESPool) method, which is based on edges (or chemical bonds). MESPool preserves crucial edges and shrinks others inside the functional groups and is able to search for key structures without breaking the original connection. We compared MESPool with various well-known pooling methods on different benchmarks and showed that MESPool outperforms the previous methods. Furthermore, we explained the rationality of MESPool on some datasets, including a COVID-19 drug dataset.

PMID:38048081 | DOI:10.1093/bib/bbad423

Categories
Nevin Manimala Statistics

Establishment of Biliary Atresia Prognostic Classification System via Survival-Based Forward Clustering – A New Biliary Atresia Classification

Indian J Pediatr. 2023 Dec 4. doi: 10.1007/s12098-023-04915-z. Online ahead of print.

ABSTRACT

OBJECTIVES: To develop a machine learning algorithm with prognosis data to identify different clinical phenotypes of biliary atresia (BA) and provide instructions for choosing treatment schemes.

METHODS: Six hundred thirty-nine cases of type III BA were retrospectively collected from the Children’s Hospital of Fudan University from Jan 1st, 2017 to Dec 1st, 2019 as a training dataset, and a survival-based forward clustering method, which can also be used to predict the subtype of a new patient was developed to identify BA subtypes.

RESULTS: A total of 2 clusters were identified (cluster 1 = 324 and cluster 2 = 315), where cluster 2 had a lower 2 y native liver survival post-Kasai rate. The infant patients in cluster 2 have higher weight, liver, and spleen volume, wider portal vein width, and older operative age; worse coagulation and liver function results; higher grade of liver fibrosis and detection rate of hepatic portal fibrous mass, and higher recent infection detection rate of herpes simplex virus type I. With the proposed prognostic classification system, the authors predicted the subtypes of the 187 cases of type III BA in a testing dataset collected from the whole year of 2020. The p-value computed from the log-rank testing for the Kaplan-Meier survival curves of the predicted two testing groups was 0.0113.

CONCLUSIONS: This classification system would be a convenient tool to choose appropriate treatment and accelerate the choice-making between clinicians and infant patients.

PMID:38047995 | DOI:10.1007/s12098-023-04915-z