Tag: statistics

JACC Cardiovasc Interv. 2023 Jul 10;16(13):1654-1664. doi: 10.1016/j.jcin.2023.04.037.

ABSTRACT

BACKGROUND: Hypoechoic peri-stent areas in duplex ultrasonography (DUS) (ie, “halo”) have been noted following femoropopliteal artery stenting.

OBJECTIVES: This study sought to investigate the prevalence, risk factors, and potential safety implications of hypoechoic halos identified with DUS following stent implantation in the IMPERIAL (ELUVIA Drug-Eluting Stent Versus Zilver PTX Stent) and EMINENT (Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) trials.

METHODS: The IMPERIAL and EMINENT studies of femoropopliteal artery stenting included polymer-based drug-eluting stent, nonpolymer drug-coated stent, and bare metal stent treatment arms. A dedicated DUS protocol was implemented for core laboratory assessment of halo presence at study follow-up visits. Logistic regressions were used to investigate risk factors for a halo sign and its impact on clinically driven target lesion revascularization and primary patency.

RESULTS: Diagnostic DUS imaging from 659 patients was obtained at time points ranging from 6 months to 5 years post-stent implantation. Halo prevalence ranged from 20% to 35% of patients with diagnostic DUS and was present at all time intervals. Halos were identified surrounding all stent types. In analyses of patients with diagnostic imaging from at least 2 visits, halo presence typically persisted, with occasional cases of regression and development at later times. No statistically significant association was found for halo status (ie, halo vs no halo) on 1-year clinically driven target lesion revascularization (OR: 1.27; 95% CI: 0.70-2.30; P = 0.4240) or primary patency (OR: 0.68; 95% CI: 0.43-1.07; P = 0.0927).

CONCLUSIONS: A hypoechoic halo following a femoropopliteal stent procedure is a common occurrence associated with all studied stent types. The presence of a halo appears to be benign with no associated clinical sequelae or effect on target vessel revascularization rates within 1 year of stent implantation.

PMID:37438033 | DOI:10.1016/j.jcin.2023.04.037

Lancet Planet Health. 2023 Jul;7(7):e580-e589. doi: 10.1016/S2542-5196(23)00104-3.

ABSTRACT

BACKGROUND: Increasing evidence indicates that ambient outdoor temperature could affect mental health, which is especially concerning in the context of climate change. We aimed to comprehensively analyse the current evidence regarding the associations between ambient temperature and mental health outcomes.

METHODS: We did a systematic review and meta-analysis of the evidence regarding associations between ambient outdoor temperature and changes in mental health outcomes. We searched WebOfScience, Embase, PsychINFO, and PubMed for articles published from database origin up to April 7, 2022. Eligible articles were epidemiological, observational studies in humans of all ages, which evaluated real-world responses to ambient outdoor temperature, and had mental health as a documented outcome; studies of manipulated or controlled temperature or those with only physical health outcomes were excluded. All eligible studies were synthesised qualitatively. If three or more studies reported the same or equivalent effect statistics and if they had equivalent exposure, outcome, and metrics, the studies were pooled in a random-effects meta-analysis. The risk of bias for individual studies was assessed using the Newcastle-Ottawa Scale. The quality of evidence across studies was assessed using the Office of Health Assessment and Translation (OHAT) approach.

FINDINGS: 114 studies were included in the systematic review, of which 19 were suitable for meta-analysis. Three meta-analyses were conducted for suicide outcomes: a 1°C increase in mean monthly temperature was associated with an increase in incidence of 1·5% (95% CI 0·8-2·2, p<0·001; n=1 563 109, seven effects pooled from three studies); a 1°C increase in mean daily temperature was associated with an increase in incidence of 1·7% (0·3-3·0, p=0·014; n=113 523, five effects pooled from five studies); and a 1°C increase in mean monthly temperature was associated with a risk ratio of 1·01 (95% CI 1·00-1·01, p<0·001; n=111 794, six effects pooled from three studies). Three meta-analyses were conducted for hospital attendance or admission for mental illness: heatwaves versus non-heatwave periods were associated with an increase in incidence of 9·7% (95% CI 7·6-11·9, p<0·001; n=362 086, three studies); the risk ratio at the 99th percentile of daily mean temperature compared with the 50th percentile was 1·02 (95% CI 1·01-1·03, p=0·006; n=532 296, three studies); and no significant association was found between a 10°C increase in daily mean temperature and hospital attendance. In a qualitative narrative synthesis, we found that ambient outdoor temperature (including absolute temperatures, temperature variability, and heatwaves) was positively associated with attempted and completed suicides (86 studies), hospital attendance or admission for mental illness (43 studies), and worse outcomes for community mental health and wellbeing (19 studies), but much of the evidence was of low certainty with high heterogeneity.

INTERPRETATION: Increased temperature and temperature variability could be associated with increased cases of suicide and suicidal behaviour, hospital attendance or admission for mental illness, and poor community health and wellbeing. Climate change is likely to increase temperature anomalies, variability, and heatwaves as well as average temperatures; as such, health system leaders and policy makers must be adequately prepared and should develop adaptation strategies. More high-quality, standardised research is required to improve our understanding of these effects.

FUNDING: None.

PMID:37437999 | DOI:10.1016/S2542-5196(23)00104-3

CMAJ Open. 2023 Jul 12;11(4):E630-E636. doi: 10.9778/cmajo.20220227. Print 2023 Jul-Aug.

ABSTRACT

BACKGROUND: Patients with scleroderma require a lifetime of treatment and frequent contacts with rheumatologists and other health care professionals. Although publicly funded health care systems in Canada cover many costs, patients may still face a substantial financial burden in accessing care. The purpose of this study was to quantify out-of-pocket costs borne by people with scleroderma in Canada and compare this burden for those living in large communities and smaller communities.

METHODS: We analyzed responses to a Web-based survey of people living in Canada with scleroderma. Respondents reported annual out-of-pocket medical, travel and accommodation and other nonmedical costs (2019 Canadian dollars). We used descriptive statistics to describe travel distance and out-of-pocket costs. We used a 2-part model to estimate the impact on out-of-pocket costs of living in a large urban centre (≥ 100 000 population), compared with smaller urban centres or rural areas (< 100 000 population). We generated combined mean estimates from the 2-part models using predictive margins.

RESULTS: The survey included 120 people in Canada with scleroderma. The mean, annual, total out-of-pocket costs were $3357 (standard deviation $5580). Respondents living in smaller urban centres and rural areas reported higher mean total costs ($4148, 95% confidence interval [CI] $3618-$4680) and travel or accommodation costs ($1084, 95% CI $804-$1364) than those in larger urban centres (total costs $2678, 95% CI $2252-$3104; travel or accommodation costs $332, 95% CI $207-$458).

INTERPRETATION: Many patients with scleroderma incur considerable out-of-pocket costs, and this burden is exacerbated for those living in smaller urban centres and rural areas. Health care systems and providers should consider ways to alleviate this burden and support equitable access to care.

PMID:37437955 | DOI:10.9778/cmajo.20220227

Nutr Rev. 2023 Jul 12:nuad083. doi: 10.1093/nutrit/nuad083. Online ahead of print.

ABSTRACT

CONTEXT: Rheumatoid arthritis is a chronic inflammatory disease that causes synovitis. Vitamin D deficiency is common in rheumatoid arthritis.

OBJECTIVE: This systematic review and meta-analysis investigated whether vitamin D supplementation affects the inflammatory and clinical outcomes in patients with rheumatoid arthritis on the basis of randomized clinical trials.

DATA SOURCES: A literature search was performed in the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, MEDLINE, Embase, and Google Scholar for articles published until May 2022.

DATA EXTRACTION: The studies were selected according to PRISMA guidelines, and the risk of bias was assessed for randomized controlled trials.

DATA ANALYSIS: A random effects model was used to conduct a meta-analysis, and heterogeneity was assessed using the I2 statistic. Of 464 records, 11 studies were included from 3049 patients. Conclusion: Vitamin D supplementation did not significantly reduce C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), disease activity score in 28 joints (DAS28), or the health assessment questionnaire score; however, the response to supplementation was highly heterogeneous. The pooled analysis showed that vitamin D significantly reduced the pain-visual analogue scale (VAS) weighted mean difference (WMD = -1.30, 95% confidence interval [CI] [-2.34, -27], P = .01), DAS28-CRP (WMD = -.58, 95% CI [-.86, -.31], P < .0001), and DAS28-ESR (WMD = -.58, 95% CI [-.86, -.31], P = .0001). Subgroup analysis for vitamin D doses (>100 µg per day versus <100 µg per day) showed that the higher doses had a more significant effect on CRP than the lower doses (P < .05).

CONCLUSIONS: There was no significant difference between the effect of 2 vitamin D doses on ESR and DAS28. To minimize the high heterogeneity among studies in this meta-analysis, other confounding factors such as baseline vitamin D, age, dietary vitamin D, time of year, sun exposure, drug interaction, effect dosage, and power of study should be examined.

PMID:37437898 | DOI:10.1093/nutrit/nuad083

F S Sci. 2023 Jul 10:S2666-335X(23)00037-X. doi: 10.1016/j.xfss.2023.06.003. Online ahead of print.

ABSTRACT

OBJECTIVE: Vilaprisan is a highly potent selective progesterone receptor modulator shown to reduce heavy menstrual bleeding, induce amenorrhea, and diminish uterine fibroid volume in phase 2 studies. The objective of ASTEROID 3 was to demonstrate the superiority of vilaprisan compared with placebo in the treatment of heavy menstrual bleeding in women with uterine fibroids.

DESIGN: Randomized, double-blind, placebo-controlled, multicenter phase 3 study.

SETTING: Hospitals and medical centers.

PATIENTS: Women with ≥1 uterine fibroid of ≥3 cm and heavy menstrual bleeding of >80 mL/cycle.

INTERVENTION: Women were randomly assigned to 1 of 4 treatment arms, which were planned to comprise 2 treatment periods of 12 weeks each with vilaprisan (2 mg/day) or placebo that were continuous or separated by a break of 1 bleed.

MAIN OUTCOME MEASURES: Amenorrhea (primary endpoint; <2 mL in the last 28 days of treatment) and heavy menstrual bleeding response (key secondary endpoint; <80 mL/cycle and >50% reduction in bleeding from baseline) were measured with the alkaline hematin method. Change in volume of the 3 largest fibroids from baseline to end of treatment was assessed by ultrasound. Safety was monitored throughout the study.

RESULTS: Overall, 75 women completed the first 12 weeks of treatment. Statistically significant and clinically meaningful differences were observed between the vilaprisan- and placebo-treated groups in both the full analysis and per-protocol sets. In the per-protocol set (n=36 and n=12 for the vilaprisan and placebo groups, respectively), amenorrhea was observed more frequently in women treated with vilaprisan than in those who received placebo (83.3% vs 0%, P<.0001), with a median time to onset of 3 days in the vilaprisan group. Similarly, more vilaprisan- than placebo-treated women achieved a response in heavy menstrual bleeding (91.7% vs 25.0%, P<.0001). Serious adverse events were reported for 22 of 79 women (27.8%) and were evenly distributed among the 4 groups receiving vilaprisan and/or placebo. None of these events led to study discontinuation or were related to the liver, and no new safety findings were identified compared with the earlier phase 2 ASTEROID studies.

CONCLUSIONS: Vilaprisan is efficacious and well tolerated over 12 weeks in the treatment of heavy menstrual bleeding associated with uterine fibroids. Further investigations of the long-term efficacy and safety of vilaprisan are warranted.

PMID:37437885 | DOI:10.1016/j.xfss.2023.06.003

Rev Esp Cardiol (Engl Ed). 2023 Jul 10:S1885-5857(23)00193-7. doi: 10.1016/j.rec.2023.04.008. Online ahead of print.

ABSTRACT

INTRODUCTION AND OBJECTIVES: Transcatheter aortic valve implantation (TAVI) using the cusp overlap technique (COT) has shown a lower pacemaker implantation rate at 30 days. The objective of this study was to compare electrocardiogram changes and clinical outcomes between COT and the traditional technique (TT) at 1 year of follow-up.

METHODS: Observational, retrospective, nonrandomized study of consecutive patients undergoing TAVI between January 2015 and January 2021. Patients were matched using a propensity score and the TT was compared with COT. The primary endpoints were electrocardiogram changes and a combined endpoint including pacemaker implantation, hospitalization, or cardiovascular death at 1 year.

RESULTS: We included 254 patients. After propensity score matching, 184 patients (92 per group) remained. There were no statistically significant differences in baseline characteristics. At 1 year, COT patients showed a significant reduction in new onset left bundle branch block (49% vs 27%, P = .002) and less P wave (13.1 ± 21.0 msec vs 5.47 ± 12.5 msec; P = .003) and QRS prolongation (29.77 ± 27.0 msec vs 16.38 ± 25.4 msec, P < .001). COT was associated with a significant reduction in the occurrence of the primary endpoint (SHR, 0.39 [IC95%, 0.21-0.76]; P = .005).

CONCLUSIONS: At 1 year of follow-up, COT reduced the incidence of new onset left bundle branch block and diminished QRS and P wave widening compared with the TT. COT was also associated with a statistically significant reduction in the occurrence of the combined primary cardiovascular endpoint. Full English text available from: www.revespcardiol.org/en.

PMID:37437882 | DOI:10.1016/j.rec.2023.04.008

Neurosci Lett. 2023 Jul 10:137394. doi: 10.1016/j.neulet.2023.137394. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aimed to investigate the levels of serum neurofilament light chain (NFL) and glial fibrillary acidic protein (GFAP) in patients with Parkinson’s disease (PD) and PD patients with sleep disorders (PD-SD), as well as the relationship between these proteins and sleep disorders in PD patients.

METHODS: A total of 96 PD patients and 38 healthy controls (HC) were included in this study, of which 70 PD patients experienced sleep disorders. Both motor symptoms and sleep conditions were assessed in all PD patients. The ultrasensitive single molecule array (SIMOA) technique was used to quantify NFL and GFAP in the serum. All data were statistically analyzed using SPSS 23.0.

RESULTS: Serum NFL and GFAP levels were significantly higher in PD patients than in HC. Similarly, PD-SD patients exhibited higher levels of these two proteins than PD patients without sleep disorders (PD-NSD). In addition, both serum GFAP and NFL were significantly associated with sleep-related scales in PD patients. After covariate-adjusted binary logistic regression analysis, NFL remained statistically significant in PD patients with or without sleep disorders, unlike GFAP.

CONCLUSIONS: Our findings substantiate that serum NFL and GFAP levels are elevated in PD and PD-SD, suggesting neurological axon damage in PD patients, which may be more severe in PD-SD than in PD-NSD. These findings may affect disease diagnosis and provide the foothold for future studies on the underlying mechanisms.

PMID:37437874 | DOI:10.1016/j.neulet.2023.137394

Environ Res. 2023 Jul 10:116611. doi: 10.1016/j.envres.2023.116611. Online ahead of print.

ABSTRACT

The current study aims to investigate the influence of seasonal changes on the pollution loads of the sediment of a coastal area in terms of its physicochemical features. The research will focus on analyzing the nutrients, organic carbon and particle size of the sediment samples collected from 12 different sampling stations in 3 different seasons along the coastal area. Additionally, the study discusses about the impact of anthropogenic activities such as agriculture and urbanization and natural activities such as monsoon on the sediment quality of the coastal area. The nutrient changes in the sediment were found to be: pH (7.96-9.45), EC (2.89-5.23 dS/m), nitrogen (23.98-57.23 mg/kg), phosphorus (7.75-11.36 mg/kg), potassium (217-398 mg/kg), overall organic carbon (0.35-0.99%), and sediment proportions (8.91-9.3%). Several statistical methods were used to investigate changes in sediment quality. According to the three-way ANOVA test, the mean value of the sediments differs significantly with each season. It correlates significantly with principal factor analysis and cluster analysis across seasons, implying contamination from both natural and man-made sources. This study will contribute to developing effective management strategies for the protection and restoration of degraded coastal ecosystem.

PMID:37437863 | DOI:10.1016/j.envres.2023.116611

Prog Neuropsychopharmacol Biol Psychiatry. 2023 Jul 10:110823. doi: 10.1016/j.pnpbp.2023.110823. Online ahead of print.

ABSTRACT

Various aspects of folate and tetrahydrobiopterin (BH4) metabolism disturbances have been detected in patients with schizophrenia.Data were obtained that disturbances in the pterins (folates and BH4) metabolism can be associated with oxidative stress and inflammation, but has not yet been confirmed in clinical studies in schizophrenia. Within the framework of this study, a correlation and factor analysis of biochemical markersof pterin metabolism, inflammation and redox imbalance in patients with schizophrenia was performed in order to test the hypothesis of the single etiopathogenetic node, including the studied biochemical processes. Methods: 125 patients with schizophrenia and 95 healthy volunteers were randomly selected and evaluated with a biochemical examination of BH4, folate, B12, homocysteine, C-reactive protein, interleukin-6, reduced glutathione levels in the blood serum; activity of superoxide dismutase and catalase – in erythrocytes; malondialdehyde – in blood plasma. All patients underwent an examination using standardized psychopathology rating scales. Spearman rank coefficient (ρ) with Benjamini-Hochberg correction was used for the correlation analysis. The principal components analysis (PCA) was used as a factor analysis. Results: Significant correlations were found within groups of pterin metabolism, inflammatory markers and redox-imbalance, and also between separate inflammation, oxidative stress and markers of pterin metabolism. The performed factor analysis made it possible to distinguish two components: 1 – pterin metabolism, 2 – oxidativeinflammatory markers. Despite the weak statistical associations and, possibly, functional relationships between pterin metabolism and oxidative/inflammation markers, each of the components has its own clinical correlates and, probably, a separate contribution to the pathology of schizophrenia.

PMID:37437837 | DOI:10.1016/j.pnpbp.2023.110823

Protist. 2023 May 9;174(4):125967. doi: 10.1016/j.protis.2023.125967. Online ahead of print.

ABSTRACT

Parasitic euglenids have rarely been studied. We found parasitic euglenids in two species of ostracods (Cyprinotus cassidula, Dolerocypris sinensis) and two species of rhabdocoels (Mesostoma lingua, Microdalyellia armigera) in a rice field. These parasites grew and proliferated inside the host body. These parasites had pellicle strips, one emergent flagellum, and a red stigma, but no chloroplasts, and showed euglenoid movement. Inside the living host, they did not have emergent flagella and moved only by euglenoid movement, but when the host died or the parasites were isolated from the host, they extended their flagella and switched to swimming movement. We conclude that the parasites found in the four hosts that we examined are of the same species, considering the morphological characteristics and identities in the nSSU and nLSU rDNA sequences of those parasites. Molecular phylogenetic analysis showed that the parasite formed a clade with the free-living photoautotrophic species of Euglenaformis, with moderate statistical support. Therefore, the parasite is a secondary osmotroph derived from a photoautotrophic ancestor. Based on the results of morphological observation and molecular phylogenetic analysis, we propose a new species of parasitic euglenid, Euglenaformis parasitica sp. nov.

PMID:37437401 | DOI:10.1016/j.protis.2023.125967