Category: Nevin Manimala

Stat Med. 2023 Apr 30. doi: 10.1002/sim.9751. Online ahead of print.

ABSTRACT

Basket trials are a novel clinical trial design in which a single intervention is investigated in multiple patient subgroups, or “baskets.” They offer the opportunity to share information between subgroups, potentially increasing power to detect treatment effects. Basket trials offer several advantages over running a series of separate trials, including reduced sample sizes, increased efficiency, and reduced costs. Primarily, basket trials have been undertaken in Phase II oncology settings, but could be a promising design in other areas where a shared underlying biological mechanism drives different diseases. One such area is chronic aging-related diseases. However, trials in this area frequently have longitudinal outcomes, and therefore suitable methods are needed to share information in this setting. In this paper, we extend three Bayesian borrowing methods for a basket design with continuous longitudinal endpoints. We demonstrate our methods on a real-world dataset and in a simulation study where the aim is to detect positive basketwise treatment effects. Methods are compared with standalone analysis of each basket without borrowing. Our results confirm that methods that share information can improve power to detect positive treatment effects and increase precision over independent analysis in many scenarios. In highly heterogeneous scenarios, there is a trade-off between increased power and increased risk of type I errors. Our proposed methods for basket trials with continuous longitudinal outcomes aim to facilitate their applicability in the area of aging related diseases. Choice of method should be made based on trial priorities and the expected basketwise distribution of treatment effects.

PMID:37120858 | DOI:10.1002/sim.9751

Top Stroke Rehabil. 2023 Apr 30:1-12. doi: 10.1080/10749357.2023.2207286. Online ahead of print.

ABSTRACT

BACKGROUND: Currently, little is known on the relationships between cardiorespiratory fitness (CF), physical activity (PA), and functional outcomes after stroke, especially in low- and middle-income countries.

OBJECTIVES: We examine the relationships between CF, PA, and functional outcomes in one-year poststroke in Benin, a lower middle-income country.

METHODS: A case-control study was carried out in northern Benin. Twenty-one participants with chronic strokes were matched to 42 controls according to sex and age. PA patterns and associated energy expenditure (EE) were assessed with a BodyMedia’s senseWear armband. CF was evaluated with the Physical Working Capacity at 75% of the predicted maximal heart rate index. The functional outcomes were evaluated using the modified Rankin scale (mRS) and the ACTIVLIM-Stroke scale.

RESULTS: Both people with stroke and the healthy pairs spent much time in sedentary behavior (median [P25; P75]: 672 [460; 793] min vs 515 [287; 666] min, p = 0.006). Although people with chronic stroke performed fewer steps compared to healthy controls (median: 2767 vs 5524, p = 0.005), results showed that total EE was not statistically significant in either group (median: 7166 Kcal vs 8245 Kcal, p = 0.07). In addition, the mRS score (r = 0.47, p = 0.033) and the ACTIVLIM-Stroke measure (r = 0.52, p = 0.016) were moderately associated with the CF index of people with chronic stroke.

CONCLUSION: The study showed clear trends for lower levels of PA in both people with chronic stroke and health controls. A correlation exists between CF, disability, and functional outcomes among stroke patients.

PMID:37120850 | DOI:10.1080/10749357.2023.2207286

Soc Work Health Care. 2023 Apr 30:1-17. doi: 10.1080/00981389.2023.2207614. Online ahead of print.

ABSTRACT

Consumer credit score has been used as an indicator of financial strain that could potentially impact health. Subjective financial well-being, or one’s feelings about one’s expectations, preferences, and satisfaction with their financial situation, is related to financial strain. This study examined whether subjective financial well-being mediates the association between credit score and self-reported physical health in a national representative sample. Using structural equation modeling (SEM), we test whether a mediating association exists between self-rated credit score and self-rated physical health. Results suggest that, after controlling for sociodemographic variables, those who reported higher credit scores have better health (β = 0.175, p < .001) and higher financial well-being (β = 0.469, p < .001), and those who reported higher financial well-being have better health (β = 0.265, p < .001). The mediation effect of financial well-being on the association between credit and physical health is also positive and statistically significant (β = 0.299, p < .001). Thus, subjective feelings about one’s financial situation would enhance the observed positive association between credit and health. Practice and policy implications are included.

PMID:37120849 | DOI:10.1080/00981389.2023.2207614

Clin Exp Hypertens. 2023 Dec 31;45(1):2205050. doi: 10.1080/10641963.2023.2205050.

ABSTRACT

PURPOSE: This study intends to investigate the correlation between blood pressure variability (BPV) levels and the use of optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) to measure retinal microvasculature in hypertensive patients.

METHODS: All individuals in the study had 24-hour ambulatory blood pressure monitoring and bilateral OCT and OCTA exams, and only data from the right eye were analyzed statistically.

RESULTS: The study included 170 individuals, with 60 in the control group. The experimental group was separated into two groups based on the average real variability (ARV) median, with 55 in the low ARV group and 55 in the high ARV group. The mean thicknesses of the Retinal Nerve Fiber Layer (RNFL), internal limiting membrane-retinal pigment epithelial cell layer (ILM-RPE), vessel density (VD), and perfusion density (PD) in the high-ARV group were substantially lower in the low-ARV and control groups (p＜0.05). Multiple linear regression analysis revealed that disease duration, age, and 24 h diastolic standard deviation all affected RNFL mean thickness (p＜0.05). VD and PD were influenced by disease duration, systolic-ARV, daytime systolic blood pressure, intraocular pressure(IOP), and best-corrected visual acuity (BCVA) (p＜0.05). And the change in VD was connected to best-corrected visual acuity.

CONCLUSION: Hypertensive retinopathy is related to BPV. In clinical practice, we can assess the degree of BPV and retinopathy in hypertensive patients to track the progression of hypertension-mediated organ damage (HMOD). Correction of BPV may help treat or postpone the progression of HOMD.

PMID:37120839 | DOI:10.1080/10641963.2023.2205050

Pacing Clin Electrophysiol. 2023 Apr 30. doi: 10.1111/pace.14704. Online ahead of print.

ABSTRACT

INTRODUCTION: Sodium-glucose co-transporter 2 (SGLT-2) inhibitors have been shown to reduce the risk of atrial fibrillation (AF) occurrence in patients with diabetes mellitus (DM). In this prospective study, we aimed to analyze the effect of SGLT-2 inhibitors as an add-on therapy to metformin on P wave indices and atrial electromechanics in patients with type 2 DM.

METHODS: A total of 144 patients enrolled. Electrocardiographic indices were recorded on admission and at 3rd and 6th month of the combination therapy. P wave indices and atrial electromechanical coupling intervals were measured and compared.

RESULTS: Although decrease in P wave dispersion (62.78 ± 9.59 vs. 53.62 ± 10.65; p = .002) became significant at 6th month of combination therapy, significant decreases in P wave terminal force in V₁ (37.79 ± 3.45 vs. 32.01 ± 5.74; p = .035), left atrial volume index (35.87 ± 6.57 vs. 31.33 ± 7.31; p = .042), left sided intra-atrial electromechanical delay (32.09 ± 9.17 vs. 27.61 ± 8.50; p = .016), right sided intra-atrial electromechanical delay (31.82 ± 4.92 vs. 27.65 ± 8.05; p = .042), and interatrial electromechanical delay (29.65 ± 7.52 vs. 25.96 ± 4.30; p = .044) were seen as early as 3rd month of treatment. Besides, there was no statistically significant difference between Empagliflozin and Dapagliflozin subgroups in terms of mentioned parameters.

CONCLUSION: SGLT-2 inhibitors as an add-on therapy to metformin were shown to significantly improve P wave indices and atrial electromechanics in type 2 DM patients as early as the 3rd month of treatment. It was thought that this may be one of the underlying mechanisms of the decrease in the frequency of AF with the use of SGLT2 inhibitors.

PMID:37120828 | DOI:10.1111/pace.14704

Nurs Open. 2023 Apr 30. doi: 10.1002/nop2.1768. Online ahead of print.

ABSTRACT

AIM: This study aims to investigate the nursing staff’s knowledge and attitudes regarding pain management in the Eastern Province of Saudi Arabia.

DESIGN: A quantitative descriptive cross-sectional survey.

METHODS: Between January and March of 2020, 183 registered nurses from two hospitals in the Eastern Province of Saudi Arabia participated in the Nurses’ Knowledge and Attitude Survey regarding Pain. We determined the average mean score for both the individual and the aggregate scores and the t-test.

RESULTS: The nurses had an inadequate level of knowledge and attitude regarding pain based on the average mean score for this factor. There was a statistically significant correlation between length of time spent working as a registered nurse and the nurses’ reported scores on tests measuring their knowledge and attitude towards pain.

PMID:37120822 | DOI:10.1002/nop2.1768

West Afr J Med. 2023 Apr 28;40(4):428-434.

ABSTRACT

BACKGROUND: Yellow fever has become a re-emerging disease of public health importance, especially in endemic areas like Nigeria and South America. Since 2017, Nigeria has been riddled with yearly outbreaks of the disease despite the availability of a safe and effective vaccine which was introduced into the country’s Expanded Programme on Immunization in 2004. We aim to describe the presentation pattern of patients with the disease who were managed in the 2020 outbreak that occurred in Delta State.

METHODS: Data were collected from the case notes of 27 patients managed for the disease using a proforma to describe their symptoms, signs, treatment measures, and outcomes. This was a facility-based retrospective cross-sectional record review carried out in the hospital’s isolation ward. Data were analyzed with IBM Statistical Product and Service Solutions version 21 and presented as percentages, mean, and standard deviation.

RESULTS: Most patients were male 20 (74.1%) and the mean age of patients was 26.4 ± 13 years. The most common presenting symptoms recorded among patients were generalized weakness 27 (100%), closely followed by fever 25 (92.6%), vomiting 20 (74.1%), and jaundice 18 (66.7%). Eleven (40.7%) had blood transfusion while only 2 (7.4%) had oxygen therapy.

CONCLUSION: Young adults and males were most affected, and the most common presentation was generalized weakness closely followed by fever. A high index of suspicion of yellow fever infection by healthcare workers will aid in the presumptive diagnosis and care of patients.

PMID:37120797

Genet Med. 2023 Apr 27:100871. doi: 10.1016/j.gim.2023.100871. Online ahead of print.

ABSTRACT

PURPOSE: HNRNPU haploinsufficiency is associated with Developmental and Epileptic Encephalopathy 54. This neurodevelopmental disorder is characterized by developmental delay, intellectual disability, speech impairment, and early onset epilepsy. We performed genome-wide DNA methylation (DNAm) analysis in a cohort of individuals to develop a diagnostic biomarker and gain functional insights into the molecular pathophysiology of HNRNPU-related disorder.

METHODS: DNAm profiles of individuals carrying pathogenic HNRNPU variants, identified through an international multi-center collaboration, were assessed using Infinium Methylation EPIC arrays. Statistical and functional correlation analyses were performed comparing the HNRNPU cohort to 56 previously reported DNAm episignatures.

RESULTS: A robust and reproducible DNAm episignature and global DNAm profile were identified. Correlation analysis identified partial overlap and similarity of the global HNRNPU DNAm profile to several other rare disorders.

CONCLUSION: This study demonstrates new evidence of a specific and sensitive DNAm episignature associated with pathogenic heterozygous HNRNPU-variants, establishing its utility as a clinical biomarker for the expansion of the EpiSign^TM diagnostic test.

PMID:37120726 | DOI:10.1016/j.gim.2023.100871

J Clin Hypertens (Greenwich). 2023 Apr 29. doi: 10.1111/jch.14665. Online ahead of print.

ABSTRACT

This retrospective study compared cardiovascular (CV) outcomes between initial β-blocker (BB) + calcium channel blocker (CCB) dual therapy (“B + C”) and other initial dual therapies in Chinese newly diagnosed hypertensive patients. In this study, all patients in a regional electronic database with newly diagnosed hypertension from January 01, 2012 to December 31, 2016 who received any initial optimal dual therapy recommended by the Chinese hypertension guideline were included. 1:2 propensity score matching (PSM) was used to balance baseline characteristics between patients receiving B + C and patients receiving other initial dual therapies (“Others”). The primary outcome was major adverse cardiovascular events (MACE) that occurred from January 01, 2012 to December 31, 2017, consisting of non-fatal stroke, non-fatal myocardial infarction (MI), non-fatal chronic heart failure (CHF), and all-cause death. Cox proportional hazard models were used to compare these CV outcomes in the 2 matched cohorts. After the PSM, 6227 patients receiving B + C and 12 454 patients receiving Others were included. Compared to patients receiving Others, patients receiving B + C had a significantly lower risk of MACE (hazard ratio [HR] 0.85; 95% confidential interval [CI] 0.78-0.92; p < .001), non-fatal stroke (HR 0.89; 95% CI 0.81-0.98; p = .018) and non-fatal CHF (HR 0.74; 95% CI 0.63-0.86; p < .0001). Additionally, differences in risks of non-fatal MI and all-cause death between the 2 treatment cohorts were not statistically significant. In conclusion, BB + CCB initial dual therapy was associated with a lower risk of MACE, stroke, and CHF than other optimal initial dual therapies recommended by the Chinese hypertension guideline in Chinese newly diagnosed hypertensive patients.

PMID:37120711 | DOI:10.1111/jch.14665

Am J Chin Med. 2023 Apr 29:1-26. doi: 10.1142/S0192415X23500386. Online ahead of print.

ABSTRACT

Current medical treatments for endometriosis-associated pain (EAP) have limitations, including symptom recurrence and hormonal side effects. For this reason, it is important to elucidate any alternative or complementary treatments available, while Chinese herbal medicine (CHM) shows potential to be this treatment. This study aims to provide evidence for the efficacy and safety of CHM for EAP. Randomized control trials comparing CHM to other treatments for EAP in women with endometriosis were considered eligible, and they were searched for in Medline, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov, as well as in the Chinese databases Sino-Med and CNKI, from inception to October 2021. Numerous outcomes were put through meta-analysis using a weighted mean difference and a 95% CI, and the results of dichotomous data were presented as a pooled RR with a 95% CI. A total of 34 eligible studies with 3389 participants were included. Compared with no treatment, there was a statistically significant pooled benefit of CHM on dysmenorrhea at the end of 3-month treatment, and these effects continued for 3 months, but not 9 months, after treatment. Compared with conventional therapy, a significant difference was found in the levels of pelvic pain with a lower rate of hot flush and irregular vaginal bleeding at the end of treatment for 3 months, but not after treatment. Comparing combined treatment with CHM and conventional therapy with conventional therapy alone, significant decreases were found in dysmenorrhea, dyspareunia, and pelvic pain after a 3-month treatment cycle, and in dysmenorrhea after a 4-month treatment cycle with a lower hot flash rate. In conclusion, CHM, used alone or in combination with conventional therapies, appears to have benefits in relieving EAP with fewer side effects than traditional treatment.

PMID:37120704 | DOI:10.1142/S0192415X23500386