Category: Statistics

ESC Heart Fail. 2024 Jul 10. doi: 10.1002/ehf2.14751. Online ahead of print.

ABSTRACT

AIMS: Traditional approaches to designing clinical trials for heart failure (HF) have historically relied on expertise and past practices. However, the evolving landscape of healthcare, marked by the advent of novel data science applications and increased data availability, offers a compelling opportunity to transition towards a data-driven paradigm in trial design. This research aims to evaluate the scope and determinants of disparities between clinical trials and registries by leveraging natural language processing for the analysis of trial eligibility criteria. The findings contribute to the establishment of a robust design framework for guiding future HF trials.

METHODS AND RESULTS: Interventional phase III trials registered for HF on ClinicalTrials.gov as of the end of 2021 were identified. Natural language processing was used to extract and structure the eligibility criteria for quantitative analysis. The most common criteria for HF with reduced ejection fraction (HFrEF) were applied to estimate patient eligibility as a proportion of registry patients in the ASIAN-HF (N = 4868) and BIOSTAT-CHF registries (N = 2545). Of the 375 phase III trials for HF, 163 HFrEF trials were identified. In these trials, the most frequently encountered inclusion criteria were New York Heart Association (NYHA) functional class (69%), worsening HF (23%), and natriuretic peptides (18%), whereas the most frequent comorbidity-based exclusion criteria were acute coronary syndrome (64%), renal disease (55%), and valvular heart disease (47%). On average, 20% of registry patients were eligible for HFrEF trials. Eligibility distributions did not differ (P = 0.18) between Asian [median eligibility 0.20, interquartile range (IQR) 0.08-0.43] and European registry populations (median 0.17, IQR 0.06-0.39). With time, HFrEF trials became more restrictive, where patient eligibility declined from 0.40 in 1985-2005 to 0.19 in 2016-2022 (P = 0.03). When frequency among trials is taken into consideration, the eligibility criteria that were most restrictive were prior myocardial infarction, NYHA class, age, and prior HF hospitalization.

CONCLUSIONS: Based on 14 trial criteria, only one-fifth of registry patients were eligible for phase III HFrEF trials. Overall eligibility rates did not differ between the Asian and European patient cohorts.

PMID:38984466 | DOI:10.1002/ehf2.14751

Hum Brain Mapp. 2024 Jul 15;45(10):e26780. doi: 10.1002/hbm.26780.

ABSTRACT

Past cross-sectional chronic pain studies have revealed aberrant resting-state brain activity in regions involved in pain processing and affect regulation. However, there is a paucity of longitudinal research examining links of resting-state activity and pain resilience with changes in chronic pain outcomes over time. In this prospective study, we assessed the status of baseline (T1) resting-state brain activity as a biomarker of later impairment from chronic pain and a mediator of the relation between pain resilience and impairment at follow-up. One hundred forty-two adults with chronic musculoskeletal pain completed a T1 assessment comprising a resting-state functional magnetic resonance imaging scan based on regional homogeneity (ReHo) and self-report measures of demographics, pain characteristics, psychological status, pain resilience, pain severity, and pain impairment. Subsequently, pain impairment was reassessed at a 6-month follow-up (T2). Hierarchical multiple regression and mediation analyses assessed relations of T1 ReHo and pain resilience scores with changes in pain impairment. Higher T1 ReHo values in the right caudate nucleus were associated with increased pain impairment at T2, after controlling for all other statistically significant self-report measures. ReHo also partially mediated associations of T1 pain resilience dimensions with T2 pain impairment. T1 right caudate nucleus ReHo emerged as a possible biomarker of later impairment from chronic musculoskeletal pain and a neural mechanism that may help to explain why pain resilience is related to lower levels of later chronic pain impairment. Findings provide empirical foundations for prospective extensions that assess the status of ReHo activity and self-reported pain resilience as markers for later impairment from chronic pain and targets for interventions to reduce impairment. PRACTITIONER POINTS: Resting-state markers of impairment: Higher baseline (T1) regional homogeneity (ReHo) values, localized in the right caudate nucleus, were associated with exacerbations in impairment from chronic musculoskeletal pain at a 6-month follow-up, independent of T1 demographics, pain experiences, and psychological factors. Mediating role of ReHo values: ReHo values in the right caudate nucleus also mediated the relationship between baseline pain resilience levels and later pain impairment among participants. Therapeutic implications: Findings provide empirical foundations for research extensions that evaluate (1) the use of resting-state activity in assessment to identify people at risk for later impairment from pain and (2) changes in resting-state activity as biomarkers for the efficacy of treatments designed to improve resilience and reduce impairment among those in need.

PMID:38984446 | DOI:10.1002/hbm.26780

Heart Rhythm O2. 2024 Apr 27;5(6):365-373. doi: 10.1016/j.hroo.2024.04.010. eCollection 2024 Jun.

ABSTRACT

BACKGROUND: There is conflicting evidence on the efficacy of primary prevention implantable cardioverter-defibrillator (ICD) implantation in the elderly.

OBJECTIVE: The purpose of this study was to determine the efficacy and safety of ICD implantation in patients 70 years and older.

METHODS: Patients (n = 167) aged 70 years or older and eligible for ICD implantation were randomly assigned (1:1) to receive either optimal medical therapy (OMT) (n = 85) or OMT plus ICD (n = 82).

RESULTS: Of the 167 participants (mean age 76.4 years; 165 men), 144 completed the study protocol according to their assigned treatment. Average participant follow-up was 31.5 months. Mortality was similar between the 2 groups: 27 deaths in OMT vs 26 death in ICD (unadjusted hazard ratio 0.92; 95% confidence interval 0.53-1.57), but there was a trend favoring the ICD over the first 36 months of follow-up. Rates of sudden death (7 vs 5; P = .81) and all-cause hospitalization (2.65 events per participant in OMT vs 3.09 in ICD; P = .31) were not statistically significantly different. Eleven participants randomized to ICD received appropriate therapy. Five participants received an inappropriate therapy that included at least 1 ICD shock.

CONCLUSION: The study did not recruit to target sample size, and accumulated data did not show benefit of ICD therapy in patients 70 years or older. Future studies similar in design might be feasible but will need to contend with patient treatment preference given the large number of patients who do not want an ICD implanted. Further research is needed to determine whether the ICD is effective in prolonging life among elderly device candidates.

PMID:38984364 | PMC:PMC11228113 | DOI:10.1016/j.hroo.2024.04.010

Front Cardiovasc Med. 2024 Jun 25;11:1374398. doi: 10.3389/fcvm.2024.1374398. eCollection 2024.

ABSTRACT

AIMS: This study aims to investigate the effects of coronary collateral circulation (CCC) on the prognosis of chronic total occlusion (CTO) patients with or without metabolic syndrome (MetS).

METHODS: The study included 342 CTO patients who underwent successful percutaneous coronary intervention at the People’s Hospital of Liaoning Province between 1 February 2021 and 30 September 2023. The Rentrop score was used to assess the status of CCC. The outcome was major adverse cardiovascular and cerebrovascular events (MACCEs), defined as a composite of all-cause mortality, cardiac death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR), and non-fatal stroke. Univariate and multivariate logistic analyses were used to investigate the association of CCC, MetS, and MACCEs with odds ratios (ORs) and 95% confidence intervals (CIs). The effect of CCC was further investigated in different MetS, diabetes mellitus (DM), and Syntax score groups.

RESULTS: MACCEs were more common in patients with poor CCC compared to those with good CCC (38.74% vs. 16.56%). Statistical differences were found in MACCEs (OR = 3.33, 95% CI: 1.93-5.72), MI (OR = 3.11, 95% CI: 1.73-5.58), TVR (OR = 3.06, 95% CI: 1.70-5.53), and stent thrombosis (OR = 6.14, 95% CI: 2.76-13.65) between the good and poor CCC groups. Poor CCC patients with MetS had a higher incidence of MACCEs (OR = 4.21, 95% CI: 2.05-8.65), non-fatal MI (OR = 4.44, 95% CI: 2.01-9.83), TVR (OR = 3.28, 95% CI: 1.51-7.11), and stent thrombosis (OR = 10.80, 95% CI: 3.11-37.54). Similar findings were also observed in CTO patients with DM and a Syntax score ≥23.

CONCLUSION: Poor CCC could increase the risk of MACCEs in CTO patients, particularly those with MetS, DM, and a Syntax score ≥23. Further prospective, multicenter studies are needed to validate our findings and to explore potential therapeutic interventions.

PMID:38984350 | PMC:PMC11231425 | DOI:10.3389/fcvm.2024.1374398

World J Psychiatry. 2024 Jun 19;14(6):829-837. doi: 10.5498/wjp.v14.i6.829. eCollection 2024 Jun 19.

ABSTRACT

BACKGROUND: Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disorder with varied clinical courses and prognoses, not only did the patients suffer from physical impairment, but also various physical and psychiatric comorbidities. Growing evidence have suggested that mental disorders in SLE patients, can lead to various adverse consequences.

AIM: To explored the features and influencing factors of mental health in patients with SLE and clarifying the correlations between mental health and personality characteristics and perceived social support. The results would provide a basis for psychological intervention in patients with SLE.

METHODS: The clinical data of 168 patients with SLE admitted at the First Affiliated Hospital of Hainan Medical University between June 2020 and June 2022 were collected. Psychological assessment and correlation analysis were conducted using the Symptom Checklist-90 (SCL-90) and Perceived Social Support Scale, and the collected data were compared with the national norms in China. The relevant factors influencing mental health were identified by statistical analysis. A general information questionnaire, the Revised Life Orientation Test, and Short-Form 36-Item Health Survey were employed to assess optimism level and quality of life (QoL), respectively.

RESULTS: Patients with SLE obtained higher scores for the somatization, depression, anxiety, and phobic anxiety subscales than national norms (P < 0.05). A correlation was identified between total social support and total SCL-90 score or each subscale (P < 0.05). The factors significantly affecting patients’ mental health were hormone dosage and disease activity index (DAI) (P < 0.05). The average optimism score of patients with SLE was 14.36 ± 4.42, and 30 cases were in the middle and lower levels. A positive correlation was found between optimism level and QoL scores.

CONCLUSION: Patients with SLE develop psychological disorders at varying degrees, which are significantly influenced by hormone dosage and DAI. Patients’ mental health should be closely monitored during clinical diagnosis and treatment and provided adequate support in establishing positive, healthy thinking and behavior patterns and improving their optimism level and QoL.

PMID:38984348 | PMC:PMC11230090 | DOI:10.5498/wjp.v14.i6.829

World J Psychiatry. 2024 Jun 19;14(6):920-929. doi: 10.5498/wjp.v14.i6.920. eCollection 2024 Jun 19.

ABSTRACT

BACKGROUND: There is an increasingly strong demand for appearance and physical beauty in social life, marriage, and other aspects with the development of society and the improvement of material living standards. An increasing number of people have improved their appearance and physical shape through aesthetic plastic surgery. The female breast plays a significant role in physical beauty, and droopy or atrophied breasts can frequently lead to psychological inferiority and lack of confidence in women. This, in turn, can affect their mental health and quality of life.

AIM: To analyze preoperative and postoperative self-image pressure-level changes of autologous fat breast augmentation patients and their impact on social adaptability.

METHODS: We selected 160 patients who underwent autologous fat breast augmentation at the First Affiliated Hospital of Xinxiang Medical University from January 2020 to December 2022 using random sampling method. The general information, self-image pressure level, and social adaptability of the patients were investigated using a basic information survey, body image self-assessment scale, and social adaptability scale. The self-image pressure-level changes and their effects on the social adaptability of patients before and after autologous fat breast augmentation were analyzed.

RESULTS: We collected 142 valid questionnaires. The single-factor analysis results showed no statistically significant difference in the self-image pressure level and social adaptability score of patients with different ages, marital status, and monthly income. However, there were significant differences in social adaptability among patients with different education levels and employment statuses. The correlation analysis results revealed a significant correlation between the self-image pressure level and social adaptability score before and after surgery. Multiple factors analysis results showed that the degree of concern caused by appearance in self-image pressure, the degree of possible behavioral intervention, the related distress caused by body image, and the influence of body image on social life influenced the social adaptability of autologous fat breast augmentation patients.

CONCLUSION: The self-image pressure on autologous fat breast augmentation patients is inversely proportional to their social adaptability.

PMID:38984330 | PMC:PMC11230084 | DOI:10.5498/wjp.v14.i6.920

JPRAS Open. 2024 May 23;41:116-127. doi: 10.1016/j.jpra.2024.04.008. eCollection 2024 Sep.

ABSTRACT

INTRODUCTION: Enhanced recovery after surgery (ERAS) protocols have been implemented to decrease opioid use and decrease patient hospital length of stay (LOS, days). Serratus anterior plane (SAP) blocks anesthetize the T2 through T9 dermatomes of the breast and can be applied intraoperatively. The purpose of this study was to compare postoperative opioid (OME) consumption and LOS between a control group, an ERAS group, and an ERAS/local anesthetic cocktail group in patients who underwent implant-based breast reconstruction.

METHODS: In this study, 142 women who underwent implant-based breast reconstruction between 2004 and 2020 were divided into Group A (46 patients), a historical cohort; Group B (73 patients), an ERAS/no-block control group; and Group C (23 patients), an ERAS/anesthetic cocktail study group. Primary outcomes of interest were postanesthesia care unit (PACU), inpatient and total hospital OME consumption, and PACU LOS.

RESULTS: A significant decrease was observed from Group A to C in PACU LOS (103.3 vs. 80.2 vs. 70.5; p = 0.011), OME use (25.1 vs. 11.4 vs. 5.7; p < 0.0001), and total hospital OME (120.3 vs. 95.2 vs. 35.9; p < 0.05). No difference was observed in inpatient OMEs between the three groups (95.2 vs. 83.8 vs. 30.8; p = 0.212). Despite not reaching statistical significance, Group C consumed an average of 50-60 % less opioids per patient than did Group B in PACU, inpatient, and total hospital OMEs.

CONCLUSION: Local anesthetic blocks are important components of ERAS protocols. Our results demonstrate that a combination regional block with a local anesthetic cocktail in an ERAS protocol can decrease opioid consumption in implant-based breast reconstruction.

PMID:38984322 | PMC:PMC11231500 | DOI:10.1016/j.jpra.2024.04.008

Heliyon. 2024 Jun 15;10(12):e33134. doi: 10.1016/j.heliyon.2024.e33134. eCollection 2024 Jun 30.

ABSTRACT

Associations between brain structure and body mass index (BMI) are increasingly gaining attention. Although BMI-related regional alterations in brain morphology have been previously reported, the effect of BMI on the microstructural profiles, which provide information on the proxy of neuronal density within the cortex, is unexplored. In this study, we investigated the links between cortical layer-specific microstructural profiles and BMI in 302 neurologically healthy young adults. Using the microstructure-sensitive proxy based on the T1-and T2-weighted ratio, we estimated microstructural profile covariance (MPC) by calculating linear correlations of cortical depth-wise intensity profiles between different brain regions. Then, low-dimensional gradients of the MPC matrix were estimated using dimensionality reduction techniques, and the gradients were associated with BMI. Significant effects in the heteromodal association areas were observed. The BMI-gradient association map was related to the geodesic distance along the cortical surface, curvature, and sulcal depth, suggesting that the microstructural alterations occurred along the cortical topology. The BMI-gradient association map was further linked to cognitive states related to negative emotions. Our findings may provide insights into understanding the atypical cortical microstructure associated with BMI.

PMID:38984310 | PMC:PMC11231607 | DOI:10.1016/j.heliyon.2024.e33134

Heliyon. 2024 Jun 15;10(12):e32946. doi: 10.1016/j.heliyon.2024.e32946. eCollection 2024 Jun 30.

ABSTRACT

BACKGROUND: The rising prevalence of familial multiple sclerosis (MS) in Iran has spurred interest in the potential impact of parental consanguinity on the risk of developing the disease. This study aims to aggregate current knowledge on parental consanguinity and its possible effect on MS risk, particularly among familial MS patients from various regions and ethnicities in Iran. The objective is to enhance the understanding of MS genetics and encourage further research in this field.

MATERIALS AND METHODS: A cross-sectional study was conducted on clinically definite familial MS (FMS) patients registered in the nationwide MS registry of Iran (NMSRI). Data were extracted and supplemented with structured telephone follow-ups to gather detailed histories of MS in relatives and the familial relationships of the patients’ parents. A family penetration score was proposed. Descriptive statistics and inferential statistical tests were used to analyze the data at a significance level of 0.05, adhering to ethical guidelines.

RESULTS: Out of 19,911 individuals registered in the NMSRI, 2307 FMS patients across 13 provinces were included in the final analysis. Among these, 385 (19.3 %) reported parental consanguinity, with 283 (14.2 %) having parents who were cousins and 102 (5.1 %) having parents who were distant relatives. The data showed no significant association between parental kinship and variables such as MS phenotype, number of affected relatives with MS, hospitalization rates, and expanded disability status scale score. Similarly, MS severity did not differ based on parental consanguinity (P-value >0.05). While the rate of consanguineous marriage was higher among patients with an onset age less than 18 years, there was no statistically significant difference in disease onset age based on parental consanguinity status.

CONCLUSION: Our study highlights the complexity of factors influencing MS development, including genetic and environmental components. These results highlight the need for further research to achieve a more comprehensive understanding of MS etiology.

PMID:38984301 | PMC:PMC11231546 | DOI:10.1016/j.heliyon.2024.e32946

Biomicrofluidics. 2024 Jul 2;18(4):044101. doi: 10.1063/5.0214436. eCollection 2024 Jul.

ABSTRACT

This paper presents an innovative strategy to address the issues of clogging and cluster-related challenges in microchannels within microfluidic devices. Leveraging three-dimensional (3D) microbubble streaming as a dynamic solution, our approach involves the controlled activation of microbubbles near channel constrictions, inducing microstreaming with distinctive features. This microstreaming, characterized by a high non-uniform 3D gradient and significant shear stress, effectively inhibits arch formation at constrictions and disintegrates particle clusters, demonstrating real-time prevention of clogging incidents and blockages. This study includes experimental validation of the anti-clogging technique, a detailed examination of microstreaming phenomena, and their effects on clogging and clustering issues. It also incorporates statistical analyses performed in various scenarios to verify the method’s effectiveness and adaptability. Moreover, a versatile control system has been designed that operates in event-triggered, continuous, or periodic modes, which suits different lab-on-a-chip applications and improves the overall functionality of microfluidic systems.

PMID:38984267 | PMC:PMC11232117 | DOI:10.1063/5.0214436