Months In Group Research Articles

A randomised controlled trial to evaluate the use of genotyping and therapeutic drug monitoring versus only therapeutic drug monitoring as a strategy for risk minimisation in patients of epilepsy on phenytoin therapy

Objectives: Phenytoin has a unique feature of accumulating in the body due to its non-linear elimination kinetics. Being a drug with a narrow therapeutic index, phenytoin needs routine therapeutic drug monitoring (TDM) to adjust the dose. Polymorphisms in cytochrome P450 (CYP [2C9 and C19]) genes reduce drug metabolism, increase drug concentrations and thus produce adverse drug reactions (ADRs). Detection of polymorphisms helps to predict the susceptibility to toxicity. Hence, this study was designed to compare the addition of genotyping to TDM of phenytoin as an investigational tool for assessing plasma levels and occurrence of ADRs in epileptic patients on phenytoin therapy as a part of risk minimisation. Materials and Methods: This randomised controlled trial was prospective and double-blind. Epileptic patients were randomised into two groups. One group received therapeutic doses of phenytoin based on their CYP2C9 and CYP2C19 genotyping, followed by monitoring drug levels by TDM. The other group was treated with phenytoin based on the clinician’s judgement. Monitoring of blood levels was done by TDM. Chi-squared test was used to analyse the difference in the occurrence of ADRs between the two groups. Results: In each group, Group A (genotyping and TDM) and Group B (TDM alone), 30 patients were enrolled, totalling 60 patients. Baseline characteristics of participants with or without CYP2C9 and CYP2C19 expression were statistically not significant. At the 6-month follow-up visit, in both CYP2C9 and CYP2C19 groups, the plasma concentration of phenytoin was statistically significant. We found 10 ADRs, and between the two groups, the difference in the occurrence of ADRs was non-significant. Conclusion: We found no significant utility of the addition of the genotyping in risk minimisation of phenytoin when used with TDM. Genotyping can be considered at the time of initiation of phenytoin therapy in epileptic patients.

P-1204. Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in Ontario, Canada

Abstract Background Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract illness (LRTI) among children, particularly in young infants. Although the burden of illness is higher at a younger age, it has been less documented in children 5-17 years old. *Missing and Not Applicable categories not considered while calculating % #Risk status includes conditions such as congenital malformations, cystic fibrosis, chronic respiratory disease, trisomy 21, cardiovascular disorders, congenital kidney disease (in < 2 years only), congenital neurological disorders (in < 2 years only), cancer (in 2-17 years only), immunodeficiencies (in 2-17 years only), and neuromuscular diseases (in 2-17 years only) RSV: respiratory syncytial virus; wGA: weeks of gestational age Methods Patients aged ≤ 17 years hospitalized with RSV between July 1st, 2010 and March 31st, 2023 were identified from provincial administrative data at ICES, which captures all healthcare encounters within Ontario’s publicly funded healthcare system. Annual outcomes were reported from July 1st to June 30th of the next year.Figure 1.RSV hospitalizations among Ontario children < 12 months old (2010 – 2023).Note that the age groups are not consistent in size (i.e., 1-month groups for those < 7 months while 7 - < 12 months were all grouped together). Results Overall, 23,930 RSV hospitalizations were reported; annual counts ranged between 1,356 (2010-11) and 4,298 (2022-23) (Table 1). Children < 12 months accounted for 66% of all hospitalizations, of which > 75% occurred in those < 6 months (Figure 1), and over 90% of hospitalizations occurred during the RSV-season (November-April). Although children < 2 years made up a greater proportion of hospitalizations compared to those 2-17 years (84% vs. 16%), risk conditions were more common in those 2-17 years compared to < 2 years of age (35% vs. 7%). The median length of stay (LOS) per RSV hospitalization was 69 hours (h). Longer LOS was observed for those hospitalized at age < 1 month (108 h), 5-17 years (92 h), born preterm (84-115 h), with a low birthweight (87-119 h), or with a risk condition (92-97 h). About 12% of the cohort had an intensive care unit (ICU) stay (median LOS: 87 h), which made up 55% of their LOS in the hospital. A greater proportion of those hospitalized at < 4 months old (16%) or 5-17 years old (22%) had an ICU stay. While the proportion of patients with an ICU stay increased from 8% in 2010-11 to 17% in 2022-23, the median LOS in ICU decreased from 101 h to 78 h over the same period. Overall, in-hospital, all-cause mortality was 0.12%, but higher for those with risk conditions (< 2 years: 0.61%; 2-17 years: 1.02%). Conclusion This study highlighted those who may be more impacted by RSV illness: younger infants, those born prematurely or with a low birthweight, and with underlying risk conditions. While most hospitalizations were observed in those < 12 months, RSV remains a noteworthy cause of hospitalization in older children, especially those with risk conditions. Disclosures Sazini Nzula, PhD, Pfizer Canada: Employee Alexandra Goyette, MSc, Pfizer: Employee|Pfizer: Stocks/Bonds (Private Company) Deshayne B. Fell, PhD, Pfizer Inc.: Employment|Pfizer Inc.: Stocks/Bonds (Private Company) Ana Gabriela Grajales, MD, Pfizer Canada ULC: I am currently an employee in Medical Affairs|Pfizer Canada ULC: Stocks/Bonds (Public Company)

Long-term excessive salt consumption alters villous and crypt morphology and the protein expression of uroguanylin, TRPV6 and PMCA1b in the rat small intestine.

Although long-term high dietary sodium consumption often aggravates hypertension and bone loss, sodium in the intestinal lumen has been known to promote absorption of nutrients and other ions, e.g., glucose and calcium. However, whether high-salt diet (HSD) altered mucosal morphology, villous cell turnover and calcium transporter expression remained elusive. Herein, rats were treated with HSD containing 8% wt/wt NaCl for up to 5 months. HSD rats exhibited a marked increase in sodium intake with high fecal and urinary sodium excretion, as compared to the control group treated with normal diet. Intestinal histomorphometry revealed increasing of crypt depth and villous height in 3- and 4-month HSD groups, respectively, consistent with larger mucosal-to-serosal amplification ratio that reflected an increased surface area for nutrient absorption. The signals of Ki-67-positive cells was enhanced in the crypts as visualized by multiphoton fluorescence microscopy, whereas the TUNEL-positive cells were decreased in the villi of HSD, suggesting greater crypt cell proliferation and a reduction of villous cell apoptosis. Confocal microscopy showed higher expression of TRPV6 protein in the villous tip of HSD, while PMCA1 expression was increased in villous tip and crypt areas. The percentage of cells with highly expressed uroguanylin-an endogenous intestinal natriuretic peptide-was significantly higher in HSD group. In conclusion, HSD profoundly changed the intestinal morphology and turnover of epithelial cell, increased the expression of calcium transporters and uroguanylin. Our findings reflect pathophysiological adaptations in the intestine, which might be another target organ for drug discovery against HSD-induced osteopathy in the future.

Impact of a community-based lifestyle intervention with initial sedentary reduction or physical activity increasing goals on self-reported health-related quality of life.

In previous efforts, health-related quality of life (HRQoL) improved for individuals at high risk of type 2 diabetes and cardiovascular disease after participation in community-based lifestyle interventions (LI) with a moderate-to-vigorous physical activity (MVPA) movement goal. It is unknown whether HRQoL improves with LI when the primary movement goal is to reduce sedentary behavior. HRQoL changes were examined among adults with overweight and prediabetes and/or metabolic syndrome randomized to a 12-month Diabetes Prevention Program-based Group Lifestyle Balance (DPP-GLB) community LI work with goals of weight-loss and either increasing MVPA (DPP-GLB) or reducing sedentary time (GLB-SED). Study participants (N = 269) completed the Euroqol 5 dimension 3 long (EQ5D-3L index and EuroQol Visual Analog Scale (EQVAS)-visual analog scale) at baseline, and 6 and 12 months. Paired t-tests were used to evaluate pre-to-post-intervention changes by arm. Mean EQVAS improvements for the GLB-SED arm at 6 and 12 months were +5.6 (SE = 1.3; P < .0001) and +4.6 (SE = 1.4; P = .0006), respectively. Similar mean EQVAS improvements were reported for the DPP-GLB arm; +5.9 (SE = 1.2; P < .0001) and +4.9 (SE = 1.2; P = .0001) at 6 and 12 months, respectively. Mean EQ5D index improvements were significant in the GLB-SED arm [6 months: +0.03 (SE = 0.01; P = .004); and 12 months: +0.04 (SE = 0.01; P = .006)], but not in the DPP-GLB arm. Participation in community LI with a primary movement goal to reduce sedentary behavior improved HRQoL at least as well as traditional LI focused more on MVPA improvement, supporting an alternate intervention strategy for those who can't or won't engage in MVPA as the primary movement goal.

ADAMTS4-Specific MR Peptide Probe for the Assessment of Atherosclerotic Plaque Burden in a Mouse Model

Introduction Atherosclerosis is the underlying cause of multiple cardiovascular pathologies. The present-day clinical imaging modalities do not offer sufficient information on plaque composition or rupture risk. A disintegrin and metalloproteinase with thrombospondin motifs 4 (ADAMTS4) is a strongly upregulated proteoglycan-cleaving enzyme that is specific to cardiovascular diseases, inter alia, atherosclerosis. Materials and Methods Male apolipoprotein E-deficient mice received a high-fat diet for 2 (n = 11) or 4 months (n = 11). Additionally, a group (n = 11) receiving pravastatin by drinking water for 4 months alongside the high-fat diet was examined. The control group (n = 10) consisted of C57BL/6J mice on standard chow. Molecular magnetic resonance imaging was performed prior to and after administration of the gadolinium (Gd)-based ADAMTS4-specific probe, followed by ex vivo analyses of the aortic arch, brachiocephalic arteries, and carotid arteries. A P value &lt;0.05 was considered to indicate a statistically significant difference. Results With advancing atherosclerosis, a significant increase in the contrast-to-noise ratio was measured after intravenous application of the probe (mean precontrast = 2.25; mean postcontrast = 11.47, P &lt; 0.001 in the 4-month group). The pravastatin group presented decreased ADAMTS4 expression. A strong correlation between ADAMTS4 content measured via immunofluorescence staining and an increase in the contrast-to-noise ratio was detected (R 2 = 0.69). Microdissection analysis revealed that ADAMTS4 gene expression in the plaque area was significantly greater than that in the arterial wall of a control mouse (P &lt; 0.001). Laser ablation–inductively coupled plasma–mass spectrometry confirmed strong colocalization of areas positive for ADAMTS4 and Gd. Conclusions Magnetic resonance imaging using an ADAMTS4-specific agent is a promising method for characterizing atherosclerotic plaques and could improve plaque assessment in the diagnosis and treatment of atherosclerosis.

Acid resistance and bond strength of calcium-containing adhesive on ename.

Marginal sealing by enamel bonding is important to enhance the durability of the restoration and prevent secondary caries after operative procedure. This study aimed to evaluate the enamel acid resistance and bond strength of an experimental calcium-containing adhesive system. All materials were provided by Kuraray Noritake Dental, Inc. (Tokyo, Japan). A calcium-containing primer (CaP) was formulated by blending 10% CaCl2 into Clearfil SE Bond2 primer. The original primer (SEP) served as a control. Clearfil SE Bond2 Bond and Clearfil Protect Bond (PBB) were used as bonding agents. Human molar enamel was used for acid-resistance evaluation. After the adhesive was applied, a resin composite was built and light-cured. The samples were then subjected to an acid-base challenge and observed under scanning electron microscopy after 1 day and 3 months of storage. Mechanical strength was evaluated using microshear bond strength (μSBS) testing on bovine incisor enamel, with tests conducted 1 day after bonding (TC0) and after 5000 thermal cycles (TC5000). Statistical analysis was performed using two-way ANOVA and t tests (α = 0.05). Acid-base resistant zones (ABRZs) formed in all groups, with thicker ABRZ formation in the CaP groups than in the SEP groups. A slope formation at the bottom of the outer lesion was noted in the PBB group. No morphological differences were found between the immediate and 3-month storage groups. The thermal cycling mode did not significantly affect the μSBS between the CaP and SEP groups. The experimental calcium-containing adhesive system formed a thicker ABRZ on enamel without affecting the μSBS. The study suggests that the experimental adhesive system enhances enamel acid resistance, forming a thicker ABRZ while maintaining bond strength, offering improved long-term protection against caries for clinical use.

Understanding Types of Stigma Experienced in Black Women Living With HIV in Baltimore, Maryland: A Mixed Methods Study.

To understand how Black or African American women living with HIV (WLH) experience different types of stigma in their daily lives. Secondary analysis of quantitative and qualitative data from a recent clinical trial in Baltimore, Maryland. Quantitative data were collected in the baseline survey, and qualitative data were gathered during 6-month follow-up focus group and individual interviews. First, we conducted an exploratory factor analysis with principal axis factoring to identify the underlying factor structure of the HIV Stigma Scale. Next, we analysed the interviews with thematic analysis to understand women's experience with different stigma types. Exploratory factor analysis revealed the HIV Stigma Scale was a one-factor scale that measured internalised stigma. However, qualitative interviews revealed that four different types of stigma were present in the everyday lives of WLH. These included the following: vicarious, enacted, internalised and perceived stigma. A current HIV stigma scale may not fully capture the stigma experiences salient to Black WLH. There is a need for internally valid quantitative measures that can adequately capture HIV stigma as experienced by Black WLH. Black WLH agreed to participate in the study, completed the HIV stigma scale and shared their experiences with us.

The Impact of Vitamin D Supplementation Duration on Early Childhood Developmental Milestones: A Retrospective Study.

Vitamin D plays a pivotal role in early childhood development, influencing skeletal strength, neuromuscular coordination, and neurodevelopment. This study aimed to evaluate the impact of different durations of Vitamin D supplementation on achieving developmental milestones. A retrospective study was conducted on 209 children, divided into two cohorts based on Vitamin D supplementation duration: six months (n = 102) and twelve months (n = 107). Developmental milestones were assessed across motor (sitting, walking), fine motor (object tracking, grasping), and social (smiling, speech) domains. Statistical analyses, including t-tests and effect size calculations, were performed to compare the mean ages of milestone achievement. The 12-month group achieved several milestones significantly earlier than the 6-month group. These included walking, object tracking, and combining words into phrases. Differences in other milestones, such as sitting and smiling, were not statistically significant. Effect sizes ranged from small to moderate. Extended Vitamin D supplementation is associated with modest yet significant advancements in key developmental milestones. However, socio-environmental factors, including parental involvement, likely contributed to these differences. This study's retrospective design limits causal interpretation, emphasizing the need for prospective, randomized studies to validate findings. These results support the potential benefits of extending Vitamin D supplementation beyond six months to optimize developmental outcomes in infants.

Effects of increasing fitness through exercise training on language comprehension in monolingual and bilingual older adults: a randomized controlled trial

ABSTRACT Exercise training has been proposed to counteract age-related cognitive decline through improvements in cardiorespiratory fitness (CRF hypothesis). Research has focused on cognitive domains like attention and processing speed, and one cross-sectional study reported a positive relationship between CRF and language production in older adults. In a randomized controlled trial, we investigated whether these benefits could extend to language comprehension in healthy older adults, and whether bilinguals, for whom language processing is more costly, would exhibit greater benefits than monolinguals. Eighty older English monolinguals and 80 older Norwegian-English bilinguals were randomized into either a 6-month exercise training group or into a passive control group. We assessed CRF (VO2peak) and language comprehension (reaction times to spoken word monitoring) in first (L1, all participants) and second language (L2, bilinguals only), before and after the intervention. We found that monolinguals in the exercise group (compared to the control group) were faster in comprehension following the intervention. Moreover, this effect was mediated by exercise-induced increases in VO2peak, supporting the CRF hypothesis. This extends previous cross-sectional research and establishes a causal link between exercise training and speeded comprehension in older monolinguals. However, despite inducing increased VO2peak, exercise training did not affect bilingual (L1 or L2) comprehension, and bilinguals in both groups were slower after the intervention period. Exploratory analyses suggested that this slowing may be driven by participants with low L2 proficiency, but further research is needed to examine whether bilingual language processing is in fact unaffected by exercise training and its consequent improvements in CRF.

Edoxaban and Cancer-Associated Venous Thromboembolism: A Meta-analysis of Clinical Trials

Introduction Cancer patients face a venous thromboembolism (VTE) risk that is up to 50 times higher compared to individuals without cancer. In 2010, direct oral anticoagulants (DOACs) such as apixaban, rivaroxaban, and edoxaban were introduced, consequently becoming the controversial oral anticoagulants for VTE therapy. This study is a meta-analysis of randomized clinical trials (RCTs) evaluating the use of edoxaban for treating VTE in cancer patients over different treatment durations. Methods Using Google Scholar, a systematic search for RCTs on edoxaban for cancer-associated VTE was performed. The data extracted covered patient numbers, age, gender, BMI, cancer type, edoxaban dosage, treatment duration, comorbidities, major bleeding, recurrent VTE incidence, and deaths. Statistical significance was set at 0.05. Results Out of 52 studies, nine with 3,190 cases met the inclusion criteria. The mean age was 66.68 years, with 1,604 females (50.28%). Major bleeding occurred in 192 patients (7.66%) in the 6- or 12-month group and 57 (8.35%) in the 3-month group (p=0.573). Recurrent VTE was observed in 145 patients (5.78%) in the 6- or 12-month group and 95 (13.91%) in the 3-month group (p&lt;0.001). Deaths from any cause totaled 548 (21.86%) in the 6- or 12-month group and 165 (24.16%) in the 3-month group (p=0.110). Conclusion Cancer patients receiving edoxaban for six or 12 months experience a lower recurrence rate of VTE compared to those on a 3-month treatment. The incidence of major bleeding appears to be similar between the two treatment durations.

Complications in Pelvic Organ Prolapse With 3-Month Versus 6-Month Pessary Care: Pilot Study.

Despite evidence emphasizing the necessity of routine care for women with pelvic organ prolapse (POP) using pessaries, the frequency of follow-up is unclear. The aim of this study was to compare the presence of complications in women with POP using vaginal pessaries with cleaning and gynecological examination every 3 or 6 months. This pilot study was a randomized clinical trial of women with advanced POP using a ring pessary. The women were randomized into 2 groups ("3-month group" and a "6-month group") that returned for evaluation by a health care professional that monitored the vagina, removed the pessary, cleaned it, and reinserted it. Sociodemographic and clinical data were collected. During their follow-up, the women answered a questionnaire regarding the presence of vaginal symptoms and had a physical examination and vaginal sampling for microbiological analysis. A total of 38 women were randomized into 2 groups: the 3-month group (n = 18) and the 6-month group (n = 20). Baseline characteristics of the groups were similar except for age, which was 70.7 (±7.4) years in the 3-month group and 74.7 (±6.6) years in the 6-month group (P = 0.022). Regarding physical examination, after 12 months of follow-up, 4 women in each group presented erosions or ulcers in each group, but without difference (P = 1). The presence of bacterial vaginosis was more frequent in the group with cleaning every 6 months (P = 0.026). The prevalence of ulcerations was similar in both groups with cleaning every 3 or 6 months, but the group with cleaning every 6 months showed a higher prevalence of bacterial vaginosis.

Optimizing continuous passive motion duration following arthroscopic release of elbow contracture: a retrospective study.

The anatomical structure of the elbow joint makes it vulnerable to contractures. While elbow arthroscopy minimizes soft tissue damage and enhances early rehabilitation, the optimal duration for postoperative Continuous Passive Motion (CPM) therapy is unclear. This retrospective study aims to establish the appropriate duration of CPM following arthroscopic elbow contracture release. We analyzed postoperative outcomes from patients undergoing CPM rehabilitation for 1, 3, or 5 months. Metrics such as ASES, VAS, DASH, MEPS scores, grip strength, and range of motion were assessed before surgery and at 1,3,6 and 12 months post-surgery. Patients who received 3 or 5 months of CPM therapy showed statistically significant improvements in elbow flexion-extension, range of motion, and functional scores (ASES, VAS, DASH, MEPS) compared to the 1-month group (p < 0.05). However, no significant differences were observed between the 3- and 5-month groups. A 3-month CPM period is effective for patients with higher functional demands, with no additional benefit from extending therapy to 5 months.

Time-dependent changes in medial meniscus kinematics and attachment strength after anterior root injury and repair in a large animal model.

This study investigated joint kinematics and attachment tensile mechanics following resection of the medial meniscus anterior attachment. A secondary objective investigated the repair of the attachment. Yucatan minipigs underwent unilateral surgery for either Injury (en bloc) resection of the anterior attachment of the insertional ligament, (a portion of the cranial medial meniscotibial ligament) or Repair (immediate repair with a suture anchor), with the contralateral knee as Intact control. Evaluation at 6 weeks and 6 months included joint kinematics measured from MRI acquired under knee compression and tensile testing of the attachment. Injury resulted in large levels of meniscus extrusion, despite the development of a fibrovascular scar. At 6 weeks, the meniscus extruded 1.95 mm more than Intact; at 6 months, this extrusion was reduced to 0.77 mm. Under an applied 1× body weight load, the meniscus further extruded and was not different with treatment or time. During attachment tensile testing, elongation was 0.6 mm for Intact, following Injury, elongation was 2.7 mm at 6 weeks and was partially restored to 1.5 mm at 6 months. Despite this, the cartilage wear worsened over time. Repair was inadequate to avoid the extrusion or cartilage wear seen in the injury group at 6 weeks, so it was not continued for the 6-month group. This study demonstrates that while meniscus injury is useful to study cartilage degeneration, a holistic consideration of the role of the meniscus itself, including its changing material properties and its impact on joint mechanics during injury, repair, and rehabilitation, are key factors contributing to overall joint health.

Impact of remote collaboration-based family physical activity on activity levels and quality of life in children with intellectual developmental disabilities.

Low levels of physical activity (PA) are prevalent among children with intellectual and developmental disabilities (IDD). Implementing family-based physical activities as extracurricular interventions offers a promising approach to enhancing their PA levels and promoting overall health. This study aims to explore a novel integrative strategy by combining family-based activities with school physical education classes, with the objective of enhancing PA levels and improving the quality of life (QoL) for children with IDD. Methods: A total of 36 children with IDD (mean age = 16.4 years) were randomly assigned to a 6-month intervention group (IG) or a control group (CG). Both groups received adjusted adaptive physical education, while the IG received additional family support. Assessments of PA, QoL, and the Physical Activity Enjoyment Scale (PACES) were conducted at baseline, after 6 months, and at a 2-month follow-up post-intervention. The 6-month intervention results showed that the IG had a significant increase in moderate to vigorous physical activity (MVPA) compared to the CG (p < 0.001, d = 3.87) and a reduction in sedentary behavior (p < 0.001, d = 2.28). Additionally, there were improvements in WHOQOL-DIS scores (p < 0.001, d = 1.61) and PACES scores (p < 0.001, d = 1.14). At the 2-month follow-up, the IG also showed significant improvements in MVPA, sedentary behavior, and PACES scores, all with p-values below 0.001, while no significant change was observed in WHOQOL-DIS scores (p = 0.914). Family-based physical activities facilitated through remote collaboration not only improved the PA levels of children with IDD and enhanced their quality of life, but also positively contributed to the maintenance of long-term healthy behaviors.

Rivaroxaban for 18 Months Versus 6 Months in Patients With Cancer and Acute Low-Risk Pulmonary Embolism: An Open-Label, Multicenter, Randomized Clinical Trial (ONCO PE Trial).

The optimal duration of anticoagulation therapy for patients with cancer and acute low-risk pulmonary embolism (PE) is clinically relevant, but evidence is lacking. Prolonged anticoagulation therapy could have a potential benefit for prevention of thrombotic events; however, it could also increase the risk of bleeding. In a multicenter, open-label, adjudicator-blinded, randomized clinical trial at 32 institutions in Japan, we randomly assigned patients with cancer and acute low-risk PE of the simplified version of the Pulmonary Embolism Severity Index score of 1, in a 1:1 ratio, to receive either an 18-month or a 6-month rivaroxaban treatment. The primary end point was recurrent venous thromboembolism (VTE) at 18 months. The major secondary end point was major bleeding at 18 months according to the criteria of the International Society on Thrombosis and Hemostasis. The primary hypothesis was that an 18-month treatment was superior to a 6-month treatment in terms of the primary end point. From February 2021 to March 2023, 179 patients were randomized, and after the exclusion of one patient who withdrew consent, 178 were included in the intention-to-treat population: 89 patients in the 18-month rivaroxaban group and 89 in the 6-month rivaroxaban group. The mean age was 65.7 years; 47% of the patients were men, and 12% had symptoms of PE at baseline. The primary end point of recurrent VTE occurred in 5 of the 89 patients (5.6%) in the 18-month rivaroxaban group and in 17 of the 89 (19.1%) in the 6-month rivaroxaban group (odds ratio, 0.25 [95% CI, 0.09-0.72]; P=0.01). Among 22 recurrent VTE, 5 patients presented with a symptomatic recurrent VTE; recurrent PE occurred in 11 patients, including 2 with main and 4 with lobar PEs; and recurrent deep vein thrombosis was seen in 11 patients, including 3 with proximal deep vein thromboses. The major secondary end point of major bleeding occurred in 7 of the 89 patients (7.8 %) in the 18-month rivaroxaban group and in 5 of the 89 patients (5.6%) in the 6-month rivaroxaban group (odds ratio, 1.43 [95% CI, 0.44-4.70]; P=0.55). In patients with cancer and acute low-risk PE of the simplified version of the Pulmonary Embolism Severity Index score of 1, the 18-month rivaroxaban treatment was superior to the 6-month rivaroxaban treatment with respect to recurrent VTE events.

Informal caregivers’ roles and needs regarding shared decision-making in severe aortic stenosis

ObjectiveTo provide insight into experiences, preferences and needs of informal caregivers (ICs) regarding shared decision-making (SDM) in severe aortic stenosis (AS) of patients ≥ 70 years, and the effect of the level of perceived SDM on ICs’ quality of life (QOL) and distress. MethodsMultiple methods study consisting of a questionnaire at baseline and 3-month follow-up and focus groups. ResultsNinety-nine ICs (67.6 ± 11.7 years) completed the baseline questionnaire, eighty-two ICs the follow-up questionnaire, ten ICs (70.6 ± 12.6 years) participated in two focus groups. ICs perceived that identifying them as discussion partners and addressing patients’ daily lives were least discussed with professionals (26.3 %; 59.6 %). Most ICs (63.9 %) preferred a collaborative decision-making (DM) role. The level of perceived SDM was positively associated with baseline QOL social relations (p = .038), and follow-up QOL psychological health (p = .048) and environment (p = .024). ICs experienced three roles in SDM: supporters in DM, stimulators in clarifying patient’s personal context, and DM partners. ConclusionICs play valuable roles in SDM for severe AS, but feel professionals do not consistently identify them as discussion partners. Practice implicationsProfessionals should involve ICs in SDM for discussing older patient’s QOL and personal context, which can inform personalized decisions regarding severe AS treatment.

Comparative study of midterm outcomes between Roux-en-Y gastric bypass (RYGB), diverted one-anastomosis gastric bypass (D-OAGB), and one anastomosis gastric bypass (OAGB)

PurposeDiverted one anastomosis gastric bypass (D-OAGB) is a new procedure that entails performing Roux-en-Y diversion during OAGB to preclude post-OAGB bile reflux. This study aimed to compare the mid-term outcomes of Roux-en-Y gastric bypass (RYGB) and OAGB versus D-OAGB.MethodsThis is a retrospective study that encompassed the analysis of data from patients undergoing bypass surgeries from 2015 to May 2021. The patients’ data until 2 years of follow-up were compared.ResultsThis study included 140 patients who underwent OAGB (n = 64), RYGB (n = 24), and D-OAGB (n = 52). In the OAGB, RYGB, and D-OAGB groups, complication rates were 3.1%, 8.3%, and 5.8%, respectively. At the 3-month and 6-month follow-ups, the OAGB and D-OAGB groups showed a statistically significant higher percentage of excess weight loss (EWL%). Otherwise, the weight measures and weight loss outcome were comparable among the three groups in the other follow-up visits (p > 0.05). There was a significantly lower number of gastroesophageal reflux disease (GERD) remission cases and a higher number of de novo GERD cases in the OAGB group.ConclusionD-OAGB demonstrated favorable outcomes, including lower early adverse events and superior weight loss results in the first 6 months post-surgery when compared to RYGB. The D-OAGB group also showed higher rates of GERD remission and lower de novo GERD occurrence than OAGB. Further research is warranted to validate these findings and expand our understanding of this innovative surgical approach.

Cardiac health in breast cancer (CHiB): protocol for a single-centre, randomised controlled trial.

The incidence of breast cancer has increased from 900 000 to 2.3 million new annual cases over the last 25 years. The 5-year survival rate has markedly risen to over 90% worldwide due to significant therapeutic advancements. Longer survival in patients with breast cancer means more patients may experience long-term effects of their treatments, including cancer therapy-related cardiac dysfunction (CTRCD). To date, there is no established primary prevention to minimise CTRCD. The Cardiac Health in Breast Cancer study is a two-arm, single-centre, randomised controlled trial investigating the impact of an exercise programme on cardiac changes in patients with breast cancer undergoing cardiotoxic cancer therapy. 48 females with breast cancer will be randomised to either a 12-month intervention group (IG) or a control group (CG). The IG will receive a combination of supervised high-intensity interval training (HIIT) and high-intensity resistance training (HIRT) for 6 months, while the CG will follow WHO guidelines for physical activity independently. All participants will undergo transthoracic echocardiography, cardiac magnetic resonance (CMR) imaging and cardiopulmonary exercise testing at baseline, after 6 months and after 12 months. The primary endpoint is the occurrence of symptomatic or asymptomatic CTRCD at the time points of examination, detected by cardiac imaging, which may be mitigated by structured physical exercise. Secondary endpoints include assessments of cardiac inflammation as detected by CMR, mitochondrial dysfunction, health-related quality of life, the occurrence of fatigue, depression and anxiety, as well as exercise capacity, average heart rate, heart rate variability and daily physical activity.

Efficacy and safety of long-term edoxaban treatment for low body weight cancer patients with isolated distal deep vein thrombosis: a post-hoc subgroup analysis of the ONCO DVT study

Abstract Background Low body weight is known to be a bleeding risk in the anticoagulation treatment. ONCO DVT study revealed that 12-month edoxaban treatment for cancer patients with isolated distal deep vein thrombosis (DVT) reduced a composite outcome of a symptomatic recurrent venous thromboembolism (VTE) or VTE-related death compared with 3-month edoxaban treatment. However, the efficacy and safety of long-term edoxaban treatment for cancer patients with low body weight is unclear. Purpose In this subgroup analysis, we assessed the efficacy and safety of 12-month edoxaban treatment for low body weight cancer patients with isolated distal DVT. Methods We conducted a post-hoc subgroup analysis of the ONCO DVT study in the low body weight patients. ONCO DVT study was a multicenter, open-label, adjudicator-blinded, randomized clinical trial. Cancer patients with isolated distal DVT were assigned to 12-month or 3-month edoxaban treatment. The primary endpoint was a composite outcome of a symptomatic recurrent VTE or VTE-related death at 12 months. The major secondary endpoint was major bleeding at 12 months. We enrolled patients who met low body weight defined in Japanese Version of High Bleeding Risk criteria (&amp;lt;55 kg for men, &amp;lt;50 kg for women) and evaluated the efficacy and safety of 12-month edoxaban treatment using logistic regression models and log-rank test. Results Among 601 patients in the intention-to-treat population of ONCO DVT study, 322 patients (53.6%) met low body weight: 151 patients were in 12-month edoxaban group and 171 patients were in 3-month edoxaban group. The body weight was similar between two group (47.1±5.2 kg in 12-month edoxaban group vs. 46.9±5.4 kg in 3-month edoxaban group; P=0.77). All of them used a lower dose edoxaban (30 mg once daily) following the dose reduction criteria. 12-month edoxaban group had lower rates of the primary endpoint compared with 3-month edoxaban group (2 patients (1.3%) vs. 10 patients (5.8%); Odds ratio 0.22 [95% CI, 0.05–1.00]; Log-rank P=0.036). There was no significant difference in the major secondary endpoint of major bleeding (12 patients (7.9%) in 12-month edoxaban group vs. 16 patients (9.4%) in 3-month edoxaban group; Odds ratio 0.83 [95% CI, 0.38–1.83]; Log-rank P=0.65). All clinically relevant bleeding events occurred in 22 patients (14.6%) in 12-month edoxaban group and in 27 patients (15.8%) in 3-month edoxaban group (Odds ratio 1.40 [0.90–2.19]; Log rank P=0.13), resulting in the comparable risk of bleeding in the 12-month edoxaban group. Conclusions Our study suggests that 12-month edoxaban treatment for low body weight cancer patients with isolated distal DVT prevents recurrent VTE or VTE-related death without increasing the risk of bleeding compared to 3-month edoxaban treatment.primary endpointsecondary endpoint

Home Transcutaneous Electrical Stimulation Rehabilitation Program for Patients With Ankylosing Spondylitis: Crossover Trial.

Maintaining physical function and preserving spinal flexibility have been challenging in managing ankylosing spondylitis (AS). Most rehabilitation programs, including manual therapy, massage, hydrotherapy, and acupuncture, cannot be performed at home. The effect of transcutaneous electrical nerve stimulation (TENS) was validated in treating AS, but no home TENS system has explored its efficacy to date. This study aims to evaluate the efficacy of a home TENS system with a novel treatment program for patients with AS. The modified WeHeal TS-200 TENS and galvanic response system provided home-based TENS treatment for patients with AS. Patients were divided into a 2-month course group and a 1-month course group. After the first treatment course, patients went through a washout period for the same duration of their treatment course. Participants could decide whether to accept the second course of treatment. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Schober test, finger-to-floor flexion test, enthesis score, cytokines, chemokines, inflammatory factors, and immunoglobulins were measured to evaluate its efficacy. The clinical trial protocol (1096607481) received approval from the Ministry of Health and Welfare in Taiwan. A total of 9 patients (5 in a 2-month course group and 4 in a 1-month course group) completed the first treatment course, and 5 patients (4 in a 2-month course group and 1 in a 1-month course group) completed the sequential treatment course. The weighted results showed that patients reported an improving BASFI score (mean difference -0.9, SD 1.7; P=.03) after treatment. Looking into the trajectories, declined BASFI and BASDAI scores were noticed during treatments; this score increased during the washout period. There were improving trends in the Schober test (mean difference 1.9, SD 4.9; P=.11) and finger-to-floor flexion test (mean difference -0.6, SD 9.5; P=.79), but the results were not statistically significant. The response of cytokines, chemokines, inflammatory factors, and immunoglobulins before and after treatment did not show a consistent trend, and all results were not statistically significant (all P>.05). The home TENS device demonstrated a potential role in AS management. It may improve accessibility and adherence for patients with AS and provide remote monitoring for clinicians. Further research can compare the effectiveness of electrotherapy at home or in a medical setting and focus on integrating the home TENS system and exercise program to enhance patients' physical functions and spinal flexibility.