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Nevin Manimala Statistics

Diet, cardiovascular disease, and mortality in 80 countries

Eur Heart J. 2023 Jul 6:ehad269. doi: 10.1093/eurheartj/ehad269. Online ahead of print.

ABSTRACT

AIMS: To develop a healthy diet score that is associated with health outcomes and is globally applicable using data from the Prospective Urban Rural Epidemiology (PURE) study and replicate it in five independent studies on a total of 245 000 people from 80 countries.

METHODS AND RESULTS: A healthy diet score was developed in 147 642 people from the general population, from 21 countries in the PURE study, and the consistency of the associations of the score with events was examined in five large independent studies from 70 countries. The healthy diet score was developed based on six foods each of which has been associated with a significantly lower risk of mortality [i.e. fruit, vegetables, nuts, legumes, fish, and dairy (mainly whole-fat); range of scores, 0-6]. The main outcome measures were all-cause mortality and major cardiovascular events [cardiovascular disease (CVD)]. During a median follow-up of 9.3 years in PURE, compared with a diet score of ≤1 points, a diet score of ≥5 points was associated with a lower risk of mortality [hazard ratio (HR) 0.70; 95% confidence interval (CI) 0.63-0.77)], CVD (HR 0.82; 0.75-0.91), myocardial infarction (HR 0.86; 0.75-0.99), and stroke (HR 0.81; 0.71-0.93). In three independent studies in vascular patients, similar results were found, with a higher diet score being associated with lower mortality (HR 0.73; 0.66-0.81), CVD (HR 0.79; 0.72-0.87), myocardial infarction (HR 0.85; 0.71-0.99), and a non-statistically significant lower risk of stroke (HR 0.87; 0.73-1.03). Additionally, in two case-control studies, a higher diet score was associated with lower first myocardial infarction [odds ratio (OR) 0.72; 0.65-0.80] and stroke (OR 0.57; 0.50-0.65). A higher diet score was associated with a significantly lower risk of death or CVD in regions with lower than with higher gross national incomes (P for heterogeneity <0.0001). The PURE score showed slightly stronger associations with death or CVD than several other common diet scores (P < 0.001 for each comparison).

CONCLUSION: A diet comprised of higher amounts of fruit, vegetables, nuts, legumes, fish, and whole-fat dairy is associated with lower CVD and mortality in all world regions, especially in countries with lower income where consumption of these foods is low.

PMID:37414411 | DOI:10.1093/eurheartj/ehad269

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Nevin Manimala Statistics

Highly active antiretroviral therapy discontinuation time is associated with therapeutic failure among human immunodeficiency virus (HIV)-infected immigrant adults: A cohort study from a Peruvian referral hospital during the Venezuelan exodus

Trop Med Int Health. 2023 Jul 6. doi: 10.1111/tmi.13909. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the association between Highly Active Antiretroviral Therapy (HAART) discontinuation time and therapeutic failure (TF) in Venezuelan immigrants with HIV that restart HAART.

METHODS: We carried out a retrospective cohort study in a large hospital in Peru. We included Venezuelan immigrants who restarted HAART and were followed over at least 6 months. The primary outcome was TF. Secondary outcomes were immunologic (IF), virologic (VF) and clinical (CF) failures. The exposure variable was HAART discontinuation, categorised as no discontinuation, less than 6 months, and 6 months or more. We applied generalised linear models Poisson family with robust standard errors to calculate crude (cRR) and adjusted (aRR) relative risks by statistical and epidemiological criteria.

RESULTS: We included 294 patients, 97.2% were males, and the median age was 32 years. Out of all the patients, 32.7% discontinued HAART for less than 6 months, 15.0% discontinued for more than 6 months and the remaining 52.3% did not discontinue. The cumulative incidence of TF was 27.9%, 24.5% in VF, 6.0% in IF and 6.0% in CF. Compared with non-discontinued HAART patients, the discontinuation for less than 6 months (aRR = 1.98 [95% CI: 1.27-3.09]) and from 6 months to more (aRR = 3.17 [95% CI: 2.02-4.95]) increased the risk of TF. Likewise, treatment discontinuation of up to 6 months (aRR = 2.32 [95% CI: 1.40-3.84]) and from 6 months to more (aRR = 3.93 [95% CI: 2.39-6.45]) increased the risk of VF.

CONCLUSIONS: HAART discontinuation increases the probability of TF and VF in Venezuelan immigrants.

PMID:37414409 | DOI:10.1111/tmi.13909

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Nevin Manimala Statistics

MTMR3 risk alleles enhance Toll Like Receptor 9-induced IgA immunity in IgA nephropathy

Kidney Int. 2023 Jul 4:S0085-2538(23)00472-6. doi: 10.1016/j.kint.2023.06.018. Online ahead of print.

ABSTRACT

Multiple genome-wide association studies (GWASs) have reproducibly identified the MTMR3/HORMAD2/LIF/OSM locus to be associated with IgA nephropathy (IgAN). However, the causal variant(s), implicated gene(s), and altered mechanisms remain poorly understood. Here, we performed fine-mapping analyses based on GWAS datasets encompassing 2762 IgAN cases and 5803 control individuals, and identified rs4823074 as the candidate causal variant that intersects the MTMR3 promoter in B-lymphoblastoid cells. Mendelian randomization studies suggested the risk allele may modulate disease susceptibility by affecting serum IgA levels through increased MTMR3 expression. Consistently, elevated MTMR3 expression in peripheral blood mononuclear cells was observed in patients with IgAN. Further mechanistic studies in vitro demonstrated that MTMR3 increased IgA production dependent upon its phosphatidylinositol 3-phosphate binding domain. Moreover, our study provided the in vivo functional evidence that Mtmr3-/- mice exhibited defective Toll Like Receptor 9-induced IgA production, glomerular IgA deposition, as well as mesangial cell proliferation. RNA-seq and pathway analyses showed that MTMR3 deficiency resulted in an impaired intestinal immune network for IgA production. Thus, our results support the role of MTMR3 in IgAN pathogenesis by enhancing Toll Like Receptor 9-induced IgA immunity.

PMID:37414396 | DOI:10.1016/j.kint.2023.06.018

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The reporting of study limitations in randomized controlled trials published in the leading dental journals: Is it sufficient?

J Dent. 2023 Jul 4:104603. doi: 10.1016/j.jdent.2023.104603. Online ahead of print.

ABSTRACT

OBJECTIVES: Adequate reporting of limitations is crucial to enable clinicians to accurately interpret the clinical trial findings. This meta-epidemiological study aimed to evaluate whether study limitations are reported in full-text articles of randomized controlled trials (RCTs) published in the leading dental journals. Associations between the trial characteristics and the reporting of limitations were also explored.

METHODS: RCTs published between 1st January and 31st December in the years 2011, 2016 and 2021 were identified from the 12 high impact factor dental journals (general and specialty). RCT characteristics were extracted, and reporting of limitations was recorded for the selected studies. Descriptive statistics were calculated for trial and limitations related characteristics. Univariable ordinal logistic regression models were fit to explore univariable associations between trial characteristics and reporting of limitations.

RESULTS: Two hundred and sixty-seven trials were included and analyzed. Most RCTs were published in 2021 (40.8%), had authors based in Europe (50.2%), did not have a statistician involved (88.8%) and assessed a procedure/method intervention type (40.5%). The reporting of trial limitations was generally sub-optimal. More recent trials and studies with a published protocol were associated with better reporting of limitations. The type of journal was a significant predictor for limitation reporting.

CONCLUSIONS: Within this study, the clear reporting of study limitations in the manuscripts of dental RCTs is sub-optimal and requires improvement.

CLINICAL SIGNIFICANCE: The reporting of limitations should not be viewed as a weakness of a trial but due diligence, so clinicians can fully interpret the impact of these limitations on both the validity and generalisability of the results.

PMID:37414393 | DOI:10.1016/j.jdent.2023.104603

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Low-dose CT screening in relatives with a family history of lung cancer

J Thorac Oncol. 2023 Jul 4:S1556-0864(23)00639-1. doi: 10.1016/j.jtho.2023.06.018. Online ahead of print.

ABSTRACT

BACKGROUND: The role of family history of lung cancer (LCFH) in screening using low-dose computed tomography (LDCT) has not been prospectively investigated and with long-term follow-up.

METHODS: A multicenter prospective study with up to three rounds of annual LDCT screening was conducted to determine the detection rate of LC in asymptomatic first or second-degree relatives of LCFH.

RESULTS: From 2007 to 2011, there were 1,102 participants enrolled, including 805 and 297 from simplex (SF) and multiplex families (MF), respectively (54.2% female, and 70.0% never-smokers). Last follow-up date was May 05, 2021. The overall LC detection rate was 4.5% (50/1102). The detection rate in MF was 9.4% (19/202) and 4.4% (4/91) in never-smokers and who smoked, respectively. The corresponding rates for SF were 3.7% (21/569) and 2.7% (6/223), respectively. Of them, 68.0% and 22.0% of cases with stage I and IV diseases, respectively. LC diagnoses within a 3-year interval from initial screening were younger, higher detection rate, and more stage I disease; thereafter, more stage III/IV disease and 66.7% (16/24) with negative or semi-positive nodules in initial CT scans. Within the 6-year interval, only maternal (modified rate ratio [RR]=4.46, 95% confidence interval [CI]=2.32-8.56) or maternal relative history of LC (modified RR=5.41, 95% CI=2.84-10.30) increased the risk of LC.

CONCLUSION: LCFH is a risk factor for LC, more in MF history, never-smokers, younger adults, and those with maternal relatives with LC. Randomized controlled trials are needed to confirm mortality benefit of LDCT screening in those with LCFH.

PMID:37414358 | DOI:10.1016/j.jtho.2023.06.018

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Nevin Manimala Statistics

New cervical dilation curves during labour: is there a benefit in moving from the statistical model to reality?

Gynecol Obstet Fertil Senol. 2023 Jul 4:S2468-7189(23)00153-8. doi: 10.1016/j.gofs.2023.06.005. Online ahead of print.

NO ABSTRACT

PMID:37414341 | DOI:10.1016/j.gofs.2023.06.005

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Nevin Manimala Statistics

Methodological Issues Specific to Prediction Model Development and Evaluation

Chest. 2023 Jul 4:S0012-3692(23)00945-5. doi: 10.1016/j.chest.2023.06.038. Online ahead of print.

ABSTRACT

Developing and evaluating statistical prediction models is challenging, and many pitfalls can arise. This article identifies what the authors feel are some common methodological concerns that may be encountered. We describe each problem and make suggestions on how to address them. The hope is that this manuscript will result in higher quality publications of statistical prediction models.

PMID:37414333 | DOI:10.1016/j.chest.2023.06.038

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Nevin Manimala Statistics

Low-level ambient sulfur dioxide exposure and genetic susceptibility associated with incidence of idiopathic pulmonary fibrosis: A national prospective cohort study

Chemosphere. 2023 Jul 4:139362. doi: 10.1016/j.chemosphere.2023.139362. Online ahead of print.

ABSTRACT

BACKGROUND: The association between long-term air pollution exposure and the development of idiopathic pulmonary fibrosis (IPF) has been established, but the evidence regarding the effect of low levels of air pollution, especially ambient sulfur dioxide (SO2), is limited. Besides, the combined effect and interaction between genetic susceptibility and ambient SO2 on IPF remain uncertain.

METHODS: This study retrieved data from 402,042 participants who were free of IPF at baseline in the UK Biobank. The annual mean concentration of ambient SO2 was estimated for each participant based on their residential addresses using a bilinear interpolation method. Cox proportional hazard models were used to examine the relationship between ambient SO2 and incident IPF. We further generated a polygenic risk score (PRS) for IPF and estimated the combined effects of genetic susceptibility and ambient SO2 on incident IPF.

RESULTS: After a median follow-up of 11.78 years, 2562 cases of IPF were identified. The results indicated that each 1 μg/m3 increase in ambient SO2 was associated with a hazard ratio (HR) (95% confidence interval [CI]) of 1.67 (1.58, 1.76) for incident IPF. The study found statistically significant synergistic additive interaction between genetic susceptibility and ambient SO2. Individuals with high genetic risk and high ambient SO2 exposure had a higher risk of developing IPF (HR = 7.48, 95% CI:5.66, 9.90).

CONCLUSION: The study suggests that long-term exposure to ambient SO2, even at concentrations lower than current air quality guidelines set by the Word Health Organization and European Union, may be an important risk factor for IPF. This risk is more pronounced among people with a high genetic risk. Therefore, these findings emphasize the need to consider the potential health effects of SO2 exposure and the necessity for stricter air quality standards.

PMID:37414299 | DOI:10.1016/j.chemosphere.2023.139362

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Nevin Manimala Statistics

Exploring Washing Procedures for Produce Brush Washer

J Food Prot. 2023 Jul 4:100126. doi: 10.1016/j.jfp.2023.100126. Online ahead of print.

ABSTRACT

Previous environmental monitoring projects in food production facilities have revealed inconsistencies in how produce brush washer machines are cleaned after use; thus, study of effective sanitation procedures for these machines is needed. Four chlorine solution treatments (ranging from 25-200ppm), as well as a water-only treatment, were tested for efficacy in reducing bacterial loads for a selected small brush washer machine. Results indicate that rinsing with the machine’s power and water alone, a frequent practice among some produce processors, yielded a reduction of 0.91-1.96 log CFU per brush roller in bacterial counts, which was not statistically significant (p>0.05). However, the chlorine treatments were found to be effective in reducing bacterial loads significantly, with higher concentrations being the most effective. The 200ppm and 100ppm chlorine treatments yielded bacterial reductions of 4.08 and 3.95 log CFU per brush roller respectively, leaving bacterial levels statistically similar to the levels at post-process decontamination, meaning these are the most effective at killing bacteria of all the chlorine concentrations tested. These data suggest the use of at least 100ppm chlorine sanitizer solution is a good method to sanitize hard-to-clean produce washing machines, yielding an approximate 4 log CFU reduction of the inoculated bacteria.

PMID:37414285 | DOI:10.1016/j.jfp.2023.100126

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Nevin Manimala Statistics

Compounding warning letters to 503A facilities between 2017 and 2021

J Am Pharm Assoc (2003). 2023 Jul 4:S1544-3191(23)00237-6. doi: 10.1016/j.japh.2023.06.024. Online ahead of print.

ABSTRACT

BACKGROUND: The growing population demand and the epidemic lead of Coronavirus Disease 2019 (COVID-19) have highlighted the critical importance of patient access to compounded formulations, including for special purposes such as pediatrics, geriatrics, and other uses. However, there are many potential risks, including quality issues and 503A facilities have not received valid prescriptions for individually-identified patients for a portion of the drug products they produce.

OBJECTIVE: The aim is to analyze the (503A facilities) warning letters and identify the problem of compounding medicines not meeting the USP specifications.

METHODS: Content analysis and descriptive statistics methods were used to analyze the violations of compounding warning letters from 2017 to 2021. The content of warning letter violations was analyzed in terms of both the compounding environment and 503A facilities that did not received valid prescriptions for individually-identified patients for a portion of the drug products they produced.

RESULTS: A total of 113 compounding warning letters (503A facilities, N=112) from 2017 to 2021 were analyzed in this study. The percentage of 503A facilities involved in sterile compounding environmental issues was 79.46%, with facility design and environmental controls (73/89, 82.02%), cleaning and disinfecting the compounding area (59/89, 66.29%), and personnel cleansing and garbing (44/89, 49.44%) being the top three issues. Seventy-two (72/112, 64.29%) 503A facilities that did not received valid prescriptions for individually-identified patients for a portion of the drug products they produced. Fifty-one (51/72, 70.83%) of these warning letters were related to sterile environment issues, and 28 warning letters identified specific drugs that did not qualify for Section 503A exemptions.

CONCLUSION: The warning letter of compounding drugs issued by FDA can be used as a learning tool for compounders. Compounders can learn from the experience and lessons, improve compounding operations and reduce mistakes.

PMID:37414280 | DOI:10.1016/j.japh.2023.06.024