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Safety and efficacy of sotagliflozin in patients with type II diabetes mellitus and chronic kidney disease: a meta-analysis of randomized controlled trials

J Nephrol. 2023 Dec 23. doi: 10.1007/s40620-023-01818-2. Online ahead of print.

ABSTRACT

BACKGROUND: Sotagliflozin is a dual sodium-glucose co-transporter 1 and 2 inhibitor that increases glucosuria and natriuresis in patients with type 2 diabetes mellitus (T2DM). However, the safety and efficacy in patients with concomitant chronic kidney disease (CKD) remains unclear. Therefore, we aimed to conduct a meta-analysis to evaluate the current evidence in this regard.

METHODS: We searched PubMed, Embase, Cochrane, and Web of Science for randomized controlled clinical trials on the safety and efficacy of Sotagliflozin in patients with T2DM and CKD compared with placebo. Statistical analysis was performed using RevMan 5.4. Heterogeneity was assessed with I2 statistics. The study was recorded in PROSPERO registry (CRD42023449631). RESULTS : We included three studies totaling 11,648 patients followed for 15.7 ± 5.9 months. Reduction in HbA1C (mean difference – 0.33%; 95% CI [- 0.54, – 0.11]; p = 0.003; I2 = 100%) and weight (mean difference – 1.01 kg; 95% CI [- 1.17, – 0.86]; p < 0.00001; I2 = 96%) were significantly higher in the Sotagliflozin group compared with placebo. All-cause mortality (RR 0.98; 95% CI [0.81, 1.20]; p = 0.87; I2 = 0%) and major adverse cardiovascular events (RR 0.70; 95% CI [0.40, 1.21]; p = 0.20; I2 = 39%) were not significantly different between groups. However, estimated glomerular filtration rate reduction (mean difference – 0.95; 95% CI [- 1.32, – 0.58]; p < 0.00001; I2 = 98%), genital mycotic infections (RR 2.73; 95% CI [1.96, 3.79]; p < 0.00001; I2 = 0%), diarrhea (RR 1.42; 95% CI [1.24. 1.63]; p < 0.00001; I2 = 0%) and volume depletion (RR 1.31; 95% CI [1.11, 1.56]; p = 0.002; I2 = 0%) were more common with Sotagliflozin.

CONCLUSIONS: In patients with T2DM and CKD, Sotagliflozin appears to be effective for glycemic control and weight loss. Although the medication seemed safe concerning mortality and cardiovascular events, it induced estimated glomerular filtration rate reduction, and was associated with a higher risk of genital mycotic infections, diarrhea, and volume depletion.

PMID:38141092 | DOI:10.1007/s40620-023-01818-2

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Controllable assembly of hollow interpenetrated zeolite imidazole framework nanocomposite for dopamine charge collection

Mikrochim Acta. 2023 Dec 23;191(1):48. doi: 10.1007/s00604-023-06137-8.

ABSTRACT

The synergistic armor-etching (SAE) approach was proposed using natural organic weak acid (tannic acid, i.e., TA) for the controllable assembly of hollow and interpenetrated HZIF-8@MWCNTs hybrid nanomaterial (ZIF-8, zeolitic imidazolate framework-8; MWCNTs, multi-walled carbon nanotubes), which exhibited highly ordered crystal structure and unique morphological characteristics. The SAE strategy not only can rapidly etch solid ZIF- material into a hollow structure (~ 10 min), but also form the TA shell (~ 33 nm) on its surface. Then, the HZIF-8@MWCNTs electrochemical sensor was constructed for selective and sensitive detection of the target molecule (dopamine, DA). A sequence of studies indicated that the fabricated TA coating was capable of promoting the spread of DA into the reactive centers of hollow MOF and MWCNTs, which exhibited outstanding electroanalytical characteristics through the synergistic effect. The DPV oxidation peak of DA was strongest at 50 mV vs. Ag/AgCl reference electrode. Under the optimal conditions, there are two linear dynamic ranges of current response of 0.01 ~ 10 and 10 ~ 550 µmol L– 1 with a detection limit of 0.003 µmol·L– 1 (S/N = 3). Simultaneously, the HZIF-8@MWCNTs electrochemical sensor could detect low levels of DA in real products. The recoveries of the actual sample tests were between 98.2% and 102%, and the relative standard deviation (R.S.D.) of all studies was less than 3.0%. The statistical analyses (F-test and t-test) were employed to demonstrate the accuracy of method developed. This work will enlighten researchers operating in the domain of MOFs composites, accelerating the advancement of electrochemical sensing on the basis of hollow MOFs materials.

PMID:38141091 | DOI:10.1007/s00604-023-06137-8

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Machine learning prediction models for diabetic kidney disease: systematic review and meta-analysis

Endocrine. 2023 Dec 23. doi: 10.1007/s12020-023-03637-8. Online ahead of print.

ABSTRACT

BACKGROUND: Machine learning is increasingly recognized as a viable approach for identifying risk factors associated with diabetic kidney disease (DKD). However, the current state of real-world research lacks a comprehensive systematic analysis of the predictive performance of machine learning (ML) models for DKD.

OBJECTIVES: The objectives of this study were to systematically summarize the predictive capabilities of various ML methods in forecasting the onset and the advancement of DKD, and to provide a basic outline for ML methods in DKD.

METHODS: We have searched mainstream databases, including PubMed, Web of Science, Embase, and MEDLINE databases to obtain the eligible studies. Subsequently, we categorized various ML techniques and analyzed the differences in their performance in predicting DKD.

RESULTS: Logistic regression (LR) was the prevailing ML method, yielding an overall pooled area under the receiver operating characteristic curve (AUROC) of 0.83. On the other hand, the non-LR models also performed well with an overall pooled AUROC of 0.80. Our t-tests showed no statistically significant difference in predicting ability between LR and non-LR models (t = 1.6767, p > 0.05).

CONCLUSION: All ML predicting models yielded relatively satisfied DKD predicting ability with their AUROCs greater than 0.7. However, we found no evidence that non-LR models outperformed the LR model. LR exhibits high performance or accuracy in practice, while it is known for algorithmic simplicity and computational efficiency compared to others. Thus, LR may be considered a cost-effective ML model in practice.

PMID:38141061 | DOI:10.1007/s12020-023-03637-8

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The role of cognitive reserve in mediating HIV-associated neurocognitive disorders in older adults living with-treated HIV in Mbeya, Tanzania: A cross-sectional observational study

Int J Geriatr Psychiatry. 2023 Dec;38(12):e6042. doi: 10.1002/gps.6042.

ABSTRACT

INTRODUCTION: HIV-associated neurocognitive disorders (HAND) are a spectrum of cognitive impairments in chronic HIV infection. HAND is common in sub-Saharan Africa (SSA), despite combination antiretroviral therapy (cART). Older people appear to be at increased risk. It is unknown if cognitive reserve (CR), which is protective in neurodegenerative dementias, protects against HAND.

OBJECTIVE: To evaluate the association of CR and risk of HAND in an older cART-treated population in SSA.

METHODS: Cross-sectional observational study completed in hospital outpatient clinics in Southwest Tanzania. We assessed HIV-positive participants aged ≥50 years established on cART using a neuropsychological test battery, functional assessment, informant history and depression screen. Control participants were HIV-negative individuals attending chronic disease clinics. We used operationalised Frascati criteria for HAND diagnosis. CR was measured using the Cognitive Reserve Index (CRI) and other proxy measures.

RESULTS: The prevalence of HAND was 64.4% (n = 219/343). Lower CRI score [odds ratio (OR) = 0.971, p = 0.009] and less formal education (OR = 4.364, p = 0.026) were independent risk factors for HAND but HIV-severity measures were not. Unemployment and low-skilled manual work were associated with increased risk of HAND in bivariate analysis but not in multivariable analysis.

CONCLUSIONS: Higher total CRI score and more formal education appeared to be protective against HAND, in this cohort. Potentially, cognitively and socially stimulating activities and exercise could increase cognitive reserve in later life. Cognitive reserve could possibly be more important than HIV-disease severity in risk of HAND in older people with treated HIV.

PMID:38141048 | DOI:10.1002/gps.6042

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International scientific communication on COVID-19 data: management pitfalls understanding

J Public Health (Oxf). 2023 Dec 21:fdad277. doi: 10.1093/pubmed/fdad277. Online ahead of print.

ABSTRACT

BACKGROUND: During the pandemic, countries utilized various forms of statistical estimations of coronavirus disease-2019 (COVID-19) impact. Differences between databases make direct comparisons and interpretations of data in different countries a challenge. We evaluated country-specific approaches to COVID-19 data and recommended changes that would improve future international collaborations.

METHODS: We compared the COVID-19 reports presented on official UK (National Health System), Israeli (Department of Health), Latvian (Center for Disease Prevention and Control) and USA (Centers for Disease Control and Prevention) health authorities’ websites.

RESULTS: Our analysis demonstrated critical differences in the ways COVID-19 statistics were made available to the general and scientific communities. Specifically, the differences in approaches were found in the presentation of the number of infected cases and tests, and percentage of positive cases, the number of severe cases, the number of vaccinated, and the number and percent of deaths.

CONCLUSION: Findability, Accessibility, Interoperability and Reusability principles could guide the development of essential global standards that provide a basis for communication within and outside of the scientific community.

PMID:38141038 | DOI:10.1093/pubmed/fdad277

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The differential impact of COVID-19 on the psychological stress of post-9/11 veterans: Gender, race, and ethnicity

Stress Health. 2023 Dec 23. doi: 10.1002/smi.3360. Online ahead of print.

ABSTRACT

The COVID-19 pandemic has led to economic turndowns, social restrictions, and family life alterations. The stress induced by the public health crisis and its consequences are beginning to be explored. This study examined stress experiences since the pandemic’sonset in work, financial, social, and health domainsamong a large sample of post-9/11, United States military veterans. The sample, who separated from active-duty service or deactivated from active status in a reserve component in 2016, completed an online survey (n = 3180) in 2020. Participants were 70% White non-Hispanic, 81% male, and had an average age of 38 years. Frequencies and descriptive statistics were calculated. Female veterans and veterans of colour reported significantly higher levels of stress across most life domains. The results suggest White, male, post-9/11 veterans may be somewhat protected from COVID-19 stress, but that the pandemic is exacerbatinghealth and social disparities experienced by post-9/11 veterans of colour and female veterans. Supports and comprehensive care, particularly targeted towardsat-risk populations, are likely needed to provide sufficient resources for resiliency during and after the pandemic.

PMID:38141014 | DOI:10.1002/smi.3360

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Strengthening Abortion Training: A Dilation and Evacuation Checklist in Military Resident Education

Mil Med. 2023 Dec 22:usad491. doi: 10.1093/milmed/usad491. Online ahead of print.

ABSTRACT

INTRODUCTION: A dilation and evacuation (D&E) is a safe and effective option for patients undergoing a second trimester abortion. Recent legislation and geographic restrictions threaten patients’ access to this surgical procedure, prompting a call to action to strengthen abortion training. This quality improvement project aimed to assess if a standardized lecture and checklist would improve military trainee knowledge and comfort with performing D&Es.

MATERIALS AND METHODS: Using society recommendations and incorporating available level I to III evidence, a standardized checklist for D&Es was created to include necessary equipment, procedural steps, perioperative considerations, and potential complications. The checklist and associated lecture were presented to gynecology residents from seven of the nine military training programs. Residents completed a six-question assessment regarding comfort and knowledge in performing D&Es prior to and following the intervention. Responses were ranked on a five-point Likert scale and analyzed with the Wilcoxon sign-rank test. This project was deemed exempt by the Institutional Review Board. The standard Plan, Do, Study, Act (PDSA) methodology was used for ongoing assessment of the efficacy of this quality improvement project.

RESULTS: There were 67 trainees that completed the pre-intervention assessment and 44 who completed it post-intervention, with 27 responses paired for statistical analysis. All trainees self-reported improved comfort and knowledge in all procedural aspects of D&Es, with the largest improvement observed in equipment knowledge (mean difference 1.44, P <0.001), performing procedural steps (mean difference 1.26, P <0.001), and managing complications (mean difference 1.33, P <0.001).

CONCLUSIONS: Use of an evidence-based checklist significantly improves resident knowledge and comfort with performing second trimester D&Es. In a post Dobbs environment, the military is an appropriate proxy for larger society and training programs need to develop alternatives and adjuncts to clinical training.

PMID:38140981 | DOI:10.1093/milmed/usad491

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Regional variation in incidence and prognosis of acute kidney injury

Nephrol Dial Transplant. 2023 Dec 22:gfad267. doi: 10.1093/ndt/gfad267. Online ahead of print.

ABSTRACT

BACKGROUND: Examining regional variation in acute kidney injury (AKI) and associated outcomes may reveal inequalities and possibilities for optimization of the quality of care. Using the Danish medical databases, we examined regional variation in the incidence, follow-up, and prognosis of AKI in Denmark.

METHODS: Patients with one or more AKI episodes in 2017 were identified using population-based creatinine measurements covering all Danish residents. Crude and sex-and-age-standardized incidence rates of AKI were estimated using census statistics for each municipality. Adjusted hazard ratios (aHR) of chronic kidney disease (CKD), all-cause death, biochemical follow-up, and outpatient contact with a nephrology department after AKI were estimated across geographical regions and categories of municipalities, accounting for differences in demographics, comorbidities, medication use, lifestyle and social factors, and baseline kidney function.

RESULTS: We identified 63 382 AKI episodes in 58 356 adults in 2017. The regional standardized AKI incidence rates ranged from 12.9 to 14.9 per 1 000 person-years. Compared with the Capital Region of Denmark, the aHRs across regions ranged from 1.04 to 1.25 for CKD, from 0.97 to 1.04 for all-cause death, from 1.09 to 1.15 for biochemical follow-up, and from 1.08 to 1.49 for outpatient contact with a nephrology department after AKI. Similar variations were found across municipality categories.

CONCLUSIONS: Within the uniform Danish healthcare system, we found modest regional variation in AKI incidence. The mortality after AKI was similar; however, CKD, biochemical follow-up, and nephrology follow-up after AKI varied across regions and municipality categories.

PMID:38140955 | DOI:10.1093/ndt/gfad267

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Association between adult food insecurity and mortality among adults aged 20-79 years with diabetes: A population-based retrospective cohort study

Diabet Med. 2023 Dec 23:e15268. doi: 10.1111/dme.15268. Online ahead of print.

ABSTRACT

AIMS: There is limited research on the relationship between food insecurity and mortality among individuals with diabetes. This study aims to investigate the impact of food insecurity on all-cause and cause-specific mortality in adults with diabetes.

RESEARCH DESIGN AND METHODS: This study included 5749 adults with diabetes from the National Health and Nutrition Examination Survey cycles 2003-2018 and followed up until 31 December 2019. Food insecurity was measured by the Food Security Survey Module. Cox proportional hazard models were employed to estimate hazard ratios (HRs) and 95% confidence intervals for both all-cause mortality and cause-specific mortality.

RESULTS: The weighted prevalence of full food security, marginal food security, low food security, and very low food security was 70.8%, 11.0%, 10.4%, and 7.8%, respectively. Food insecurity demonstrated a significant correlation with diminished diet quality and reduced consumption of healthy foods. Over the course of 42,272.0 person-years of follow-up, we documented 1091 deaths, of which 370 were attributed to cardiovascular disease and 180 to cancer. After adjusting for multiple variables, food insecurity scores were significantly and linearly associated with increased all-cause mortality. Comparing to full food security, participants experiencing very low food security had a multivariate-adjusted HR of 1.48 (1.12, 1.95) for all-cause mortality (ptrend = 0.010).

CONCLUSIONS: Food insecurity was associated with increased all-cause mortality and compromised diet quality, especially in individuals experiencing very low food security. Future strategies may necessitate the monitoring of and interventions for food insecurity among individuals with diabetes.

PMID:38140919 | DOI:10.1111/dme.15268

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The effectiveness and acceptability of multimedia information when recruiting children and young people to trials: the TRECA meta-analysis of SWATs

Health Soc Care Deliv Res. 2023 Nov;11(24):1-112. doi: 10.3310/HTPM3841.

ABSTRACT

BACKGROUND: The information provided to potential trial participants plays a crucial role in their decision-making. Printed participant information sheets for trials have received recurrent criticism as being too long and technical, unappealing and hard to navigate. An alternative is to provide information through multimedia (text, animations, video, audio, diagrams and photos). However, there is limited evidence on the effects of multimedia participant information on research recruitment rates, particularly in children and young people.

OBJECTIVES: The study objectives were as follows: 1. to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials 2. to evaluate the multimedia information resources in a series of Studies Within A Trial, to test their effects on recruitment and retention rates, and participant decision-making, by comparing the provision of multimedia information resources instead of printed participant information sheets, and comparing the provision of multimedia information resources in addition to printed participant information sheets.

DESIGN: Two-phase study: 1. multimedia information resources development including qualitative study; user testing study; readability metrics; enhanced patient and public involvement 2. multimedia information resources’ evaluation comprising Studies Within A Trial undertaken within host trials recruiting children and young people.

SETTING: United Kingdom trials involving patients aged under 18.

PARTICIPANTS: Development phase: n = 120 (children and young people, parents, clinicians, trial personnel). Evaluation phase: n = 1906 (children and young people being asked to take part in trials).

INTERVENTIONS: Multimedia information resources (comprising text, audio, ‘talking heads’ video, trial-specific and trial-generic animations). Printed participant information sheets.

MAIN OUTCOME MEASURES: Primary outcome: trial recruitment rate comparing multimedia information resource-only with printed participant information sheet-only provision. Secondary outcomes: trial recruitment rate comparing combined multimedia information resource and printed participant information sheet with printed participant information sheet-only provision; trial retention rate; quality of participant decision-making. Results for each trial were calculated and combined in a two-stage random-effects meta-analysis.

RESULTS: Phase 1 generated two multimedia information resource templates: (1) for children aged 6-11 years; (2) for children aged 12-18 years and parents. In the Phase 2 Studies Within A Trial the multimedia information resources improved trial recruitment, when compared to printed information alone [odds ratio (OR) = 1.54; 95% confidence interval (CI) 1.05 to 2.28; p = 0.03; I2 = 0%]. When printed participant information sheet-only provision was compared to combined multimedia information resource and printed participant information sheet provision, there was no effect on trial recruitment (OR = 0.89; 95% CI 0.53 to 1.50; I2 = 0%). There were no differences between multimedia information resource and printed participant information sheet on trial retention or participant decision-making quality. In a study within a hypothetical trial setting, multimedia information resource-only provision produced higher ratings of ‘information was easy to understand’ (Z = 3.03; p = 0.003) and ‘I had confidence in decision-making’ (Z = 2.00; p = 0.044) than printed participant information sheet-only provision.

LIMITATIONS: It was not possible to include data from three Studies Within A Trial in the meta-analysis due to limited sample size, and questionnaire return rates were low, which reduced the strength of the findings.

CONCLUSIONS: Use of multimedia information increased the rate of recruitment to trials involving children and young people compared to standard patient information sheets.

FUTURE WORK: There should be further evaluation of the effects of multimedia information on recruitment to trials involving children and young people. It would be valuable to assess any impacts of multimedia information resources on communication between trial recruiters, children and young people, and parents.

STUDY REGISTRATION: This trial is registered as TRECA ISRCTN 73136092 and Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT 97).

FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 14/21/21) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 24. See the NIHR Funding and Awards website for further award information.

PMID:38140894 | DOI:10.3310/HTPM3841