Months In Group Research Articles

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 (<55 kg for men, <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.

Let’s Get Walking: Establishing Workplace Walking Groups in a regional Public Health Department

Abstract Maintaining staff health and wellbeing (HWB) is an ongoing priority for the Department of Public Health HSE Dublin and Midlands (PHD). This is particularly important in the context of an ongoing programme of reform for Public Health in Ireland. To support this priority, in November 2023 a pilot Workplace Walking Groups initiative was established to increase workplace physical activity and build team relationships. The initiative was designed following staff feedback on team HWB initiatives in September 2023. The Model for Improvement (which includes the Plan-Do-Study-Act cycle) was used to take a structured quality improvement approach to the development and evaluation of the 4-week pilot, led by the PHD HWB Committee. Staff joined across 3 sites. Lunchtime walks were arranged for 1-2 days per week. WhatsApp groups and email supported group communication. Quantitative data on registration and attendance were collected via Microsoft Excel. A virtual focus group was arranged to gather participant feedback, which was analysed into themes. Group registration (n = 10, n = 9, n = 5) and weekly attendance varied by site (n = 10, n = 9, n = 5). Key benefits noted by participants included physical activity, building relationships with colleagues, and getting fresh air. The main barrier was the impact of work schedules on attendance. There was broad support for re-establishment of Workplace Walking Groups for 2024. This pilot Workplace Walking Groups initiative achieved its dual aim of increasing physical activity and social connection among staff. Learning from this pilot informed the launch of a 3-month Walking Groups term for Spring 2024. The initiative is now established practice and is a component of the Department’s blended working policy, being a feature of on-site working days. Key messages • Our successful pilot Workplace Walking Groups project has translated into a sustainable health and well-being initiative for staff, during a time of ongoing reform across Public Health in Ireland. • A structured approach to designing and implementing staff health promotion initiatives is crucial to support the cycle of learning and improvement, and to sustain change over time.

A Process Evaluation in a Randomized Controlled Trial among Adults with Acetabular Dysplasia

Abstract Introduction The 2021 framework from the UK’s Medical Research Council defines evaluation as a theory-driven approach to examine how well an intervention works. However, the application of these guidelines can be challenging. Therefore, using a process evaluation case study on an exercise and patient education intervention for adults with acetabular dysplasia, we reflect on which specific aspects were relevant for the evaluation of the intervention and why. We focus on detailing methods to assess implementation (process, dose, reach), acceptability, mechanisms of change, and the impact of contextual factors. Methods Two hundred trial participants aged 18-50 years will be recruited from a University Hospital in Denmark and randomised to intervention and control groups. The process evaluation adopts a concurrent mixed-methods design involving self-report questionnaires at baseline and 6-month follow-up, training records and semi-structured focus groups with intervention providers (n = 10) and healthcare managers (n = 4-6). The mechanisms of change will be explored through semi-structured one-to-one interviews (at baseline and 6-month follow-up) with 15-20 purposefully sampled trial participants, and additionally, through exploratory examinations of associations between dose and change in health outcomes at 6-month follow-up), via simple linear regression models. The acceptability and contextual factors will be explored through one-to-one participant interviews, plus focus groups with 4-6 healthcare managers. Thematic analyses of the interviews will focus on expectations, experiences, events, personal understandings and interpersonal and organisational interactions. Conclusions The presentation will explore how the operational aspects of the intervention can be assessed through a process evaluation and how these findings may improve and expand any future implementation efforts.

Telehealth based parental support over 6 months improves physical activity and sleep quality in children with autism: a randomized controlled trial

PurposeSleep disturbances are prevalent in autistic children. The emergence of telehealth offers new possibilities for remote professional intervention. By combining telehealth with parental support, this study aims to explore a novel family-based model to enhance moderate-to-vigorous physical activity (MVPA) and improve sleep quality in children with autism.MethodsThirty-four autistic children (mean age = 15.7 years) were randomly assigned to either a 6-month intervention group or a control group. Both groups received standard physical education classes at school. The intervention group received additional after-school telehealth support. MVPA and sleep quality were assessed 1 week before the intervention and at the 6-month follow-up.ResultsAfter 6 months, children in the intervention group nearly doubled their daily MVPA compared to the control group (Cohen's d = 8.34, CI95% = 6.17–10.52). Actigraphy-assessed sleep efficiency was notably higher (d = 2.35, CI95% = 1.44–3.26), and there were reductions in wake time (d = 1.65, CI95% = 0.84–2.46), sleep fragmentation (d = 0.80, CI95% = 0.07–1.52), and sleep latency (d = 0.82, CI95% = 0.09–1.54) were all reduced. These improvements in objective sleep metrics were corroborated by subjective assessments using the Sleep Disturbance Scale for Children (d = 0.86, CI95% = 0.13–1.59).ConclusionsTelehealth combined with parental support addresses barriers to enhancing health behaviors at home. This innovative model not only improves after-school MVPA and sleep quality in autistic children but also holds significant potential for benefiting other populations requiring remote support.Clinical Trial Registrationhttps://clinicaltrials.gov/study/NCT06444659?id=NCT06444659&rank=1 (NCT06444659).

52 The bag is not always bad: Implementing a two-step method for urine testing on the inpatient paediatric units

Abstract Background Urinary tract infections (UTIs) are a common source of infection in children. Best practice for diagnosis includes interpreting a urinalysis (UA) and urine culture. Urine cultures obtained through bladder catheterization are invasive and time consuming. A two-step approach with noninvasive UA screen, followed by urine culture if positive has previously demonstrated a reduction in unnecessary catheterizations and urine cultures in children 6-24 months with suspected UTIs. Pre-intervention, there was inconsistent use of screening point-of-care urinalysis prior to bladder catheterization for culture. Objectives To decrease the number of bladder catheterizations in children 6-24 months with a negative screen on Point of Care Test (POCT) urinalysis by 25% over 1 year on paediatrics wards at a paediatric tertiary care centre. Outcome measures: 1. Proportion of bladder catheterizations with negative or no UA screen prior 2. Proportion of UA completed as POCT rather than lab sample Process measures: 1. Number of urinary catheterizations performed for UTI screen 2. Number of times pathway is followed Balancing measure: 1. Missed UTIs Design/Methods Baseline data was collected from the paediatric inpatient units at a tertiary paediatric hospital from April 2020 – April 2021. A two-step pathway for collecting urine samples was adopted, including POCT UA screen on a bag sample, followed by bladder catheterization for culture if positive. The pathway was implemented using the Model for Improvement and multiple PDSA cycles. Intervention focused on education, interdisciplinary collaboration, and process standardization. Results Baseline data demonstrated a high rate of urinary catheter cultures despite a negative UA or no UA prior (69%). After pathway implementation, this rate decreased to 23%, with a reduction in initial UA collected by catheter from 14% to 5% (figure 1). The number of POCT UA performed has increased from a median of 64% pre-intervention to 80% post-intervention, resulting in fewer samples processed in the lab (figure 2). Conclusion Variability in practice for specimen choice for collection and investigation contributed to unnecessary catheterizations. Process standardization successfully improved patient-centered care and efficiency. Next steps include broadening pathway inclusion criteria to the 3–6-month age group. Potential competing interests This work was partially supported by the UMC (Utilization Management Committee) Resource Stewardship Grant. The authors declare no additional sources of funding or conflicts of interest.

Three Versus Six Months of Adjuvant Oxaliplatin-Containing Chemotherapy for Patients With Stage III Colorectal Cancer: A Contemporary Real-World Analysis.

Based on the International Duration Evaluation of Adjuvant Chemotherapy analysis, 3 months of adjuvant chemotherapy with capecitabine and oxaliplatin (CAPOX) is an option for stage III colorectal cancer (colorectal cancer [CRC]), with cost and toxicity benefits. We examined the patterns of uptake of CAPOX versus fluorouracil, leucovorin, and oxaliplatin (FOLFOX) and chemotherapy duration in a contemporary real-world cohort of patients in Canada. The provincial pharmacy database was used to identify patients with resected stage III CRC receiving adjuvant chemotherapy between January 2021 and December 2022. Demographic, tumor, and treatment information was collected and compared. Of 452 patients, 234 (52%) and 218 (48%) were planned to receive 3 and 6 months of chemotherapy, respectively. Within the 3-month group, 226 (97%) received CAPOX. Within the 6-month group, there was a 51%-49% split between CAPOX and FOLFOX. Age >70 years (P = .039), well/moderately differentiated (P = .005), and low-risk disease (P < .0001) were significantly associated with 3 months. Performance status, ileostomy, or preexisting neuropathy did not affect treatment choice. Of patients planned for 6 months, 29% had low-risk disease, with 52% of these receiving CAPOX. Patients receiving 6 months were more likely to report neuropathy (68 v 36%, P < .0001) and to stop oxaliplatin early (54 v 31%, P < .0001). The most likely reason for early adjuvant discontinuation was neuropathy in the 6-month group and gastrointestinal toxicity in the 3-month group (P < .0001). Irrespective of duration, mean time from consult to starting chemotherapy was longer for FOLFOX versus CAPOX (24 v 19 days, P = .007). In this contemporary cohort, 6 months chemotherapy is still being offered to patients with low-risk disease and is associated with more neuropathy. Exploration of patient preferences and resource costs may improve adoption of reduced duration adjuvant CAPOX in stage III CRC.

Long-term efficacy and safety of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): extended follow-up of an open-label, multicentre, randomised, non-inferiority trial

STREAM stage 2 showed that two bedaquiline-containing regimens (a 9-month all-oral regimen and a 6-month regimen with 8 weeks of aminoglycoside) had superior efficacy to a 9-month injectable-containing regimen for rifampicin-resistant tuberculosis up to 76 weeks after randomisation. Our objective in this follow-up analysis was to assess the durability of efficacy and safety, including mortality, at 132 weeks. We report the long-term outcomes from STREAM stage 2, a randomised, phase 3 non-inferiority (10% margin) trial in participants (aged ≥15 years) with rifampicin-resistant tuberculosis without fluoroquinolone or aminoglycoside resistance at 13 clinical sites in seven countries (Ethiopia, Georgia, India, Moldova, Mongolia, South Africa, and Uganda). Participants were randomly assigned 1:2:2:2 (via permuted blocks and stratified by site and HIV status plus CD4 cell count) to the 2011 WHO long regimen (terminated early), a 9-month control regimen, a 9-month oral regimen with bedaquiline (primary comparison), or a 6-month regimen with bedaquiline and 8 weeks of an injectable antituberculous drug. Participants and clinicians were aware of treatment-group assignments, but laboratory staff were masked. The primary outcome, reported previously, was favourable status (negative cultures for Mycobacterium tuberculosis without a preceding unfavourable outcome; any death, bacteriological failure or recurrence, and major treatment change were considered unfavourable) at week 76. Here we report efficacy outcomes at week 132, analysed in the modified intention-to-treat (mITT) population. Safety assessments continued to 132 weeks and were in all participants who received at least one dose of the study regimen. All comparisons used concurrently randomised participants. This trial is registered on ISRCTN (ISRCTN18148631) and is now completed. Between March 28, 2016, and Jan 28, 2020, 588 participants were randomly assigned to the long (n=32), control (n=202), oral (n=211), or 6-month (n=143) treatment regimens; 352 (60%) were male and 236 (40%) were female. Of the 556 participants on the three shorter regimens, 517 were included in the mITT population (187 in control group, 196 in oral group, and 134 in 6-month group) and 465 in the per-protocol analyses. Six additional participants had an unfavourable outcome that occurred between week 76 and the end of efficacy follow-up (one in control group, four in oral group, one in 6-month group). In the mITT population, the proportion of patients with an unfavourable outcome at the end of follow-up was 19·6% (95% CI 14·3 to 24·9) in the oral group and 29·3% (23·3 to 36·5) in the control group (-9·7 percentage points difference [95% CI -18·7 to -1·8]; psuperiority=0·024). An estimated 9·8% (95% CI 4·6 to 14·9) of participants on the 6-month regimen had an unfavourable outcome, which was significantly lower than for those concurrently on the control regimen (32·5% [23·7 to 40·2]; psuperiority<0·0001) or the oral regimen (23·8% [16·9 to 31·1]; psuperiority=0·013). Few serious or severe adverse events were reported after week 76, with no indication of a difference between the regimens. At week 132, treatment-emergent hearing loss was recorded in significantly fewer participants on the oral regimen (7/205; 3%) than the control regimen (16/198; 8%; p=0.041); there was no significant difference in severe hearing loss between the oral regimen (6/139; 4%) and the 6-month regimen (5/143; 4%; p=0·72). Death rates were low: 1·01 (95% CI 0·48 to 2·12) per 100 person-years in participants allocated to bedaquiline (ie, oral and 6-month regimen, n=287) compared with 1·52 (0·63 to 3·66) in participants on the control regimen (n=140; p=0·49). Both of the bedaquiline-containing regimens maintained superiority to the control regimen, without evidence of increased mortality, providing two additional evidence-based treatment options for patients; previous mortality concerns for bedaquiline were not substantiated. US Agency for International Development and Janssen Research & Development.

Influence of procedural timing on the preventive yield of percutaneous patent foramen ovale closure

BackgroundThe benefit of patent foramen ovale closure (PFOC) ≤9 months after a cryptogenic stroke has been demonstrated in several randomised clinical trials. There is, however, insufficient data to support PFOC...

Proximal Hamstring Avulsions: Surgical Versus Conservative Treatment Using a Shared Decision-Making Strategy

Background: Surgical treatment of patients with proximal hamstring avulsions provides good results; however, less is known about the outcome in patients who are offered conservative treatment. Purpose: To investigate the effect of surgical or conservative treatment (decided by a shared decision strategy) of proximal hamstring avulsions. Study Design: Cohort study; Level of evidence, 2. Methods: A total of 24 patients with magnetic resonance imaging–verified proximal hamstring avulsion were included and had either surgical treatment (11 patients, 45% women; mean age, 50 ± 16 years) or conservative treatment (13 patients, 46% women; mean age, 50 ± 17 years). At baseline, 6 months and 12 months, all patients answered the Perth Hamstring Assessment Tool (PHAT) (0-100 scale) and Hip Sports Activity Scale (0-8 scale). Patients had their maximal hip extension strength and maximal strength at 30° and 90° of knee flexion measured in newton meters per kilogram using a handheld dynamometer. A minimal important change in PHAT was considered &gt;7 points and a minimal important change in strength was considered &gt;0.15 N·m/kg, respectively. Results: The surgical group had a shorter time from injury to initiation of treatment compared with the conservative group (median: 15 vs 64 days; P = .02). The surgical group had a greater amount of retraction of the tendons compared with the conservative group (3 vs 2 cm; P = .04). From baseline to 12-month follow-up, the surgical and conservative groups improved their mean PHAT scores (35 points [95 CI, 24-45 points] and 20 points [95% CI, 9-31 points], respectively) reaching a median of 79 points (interquartile range [IQR], 66-95 points) in the surgical group and 75 points (IQR, 66-85 points) in the conservative group at the 12-month follow-up. Their Hip Sports Activity Scale levels at 12 months were 3 points (95% CI, 1-4 points) and 1 point (95% CI, 0-3 points) (not significant). Furthermore, the surgical and conservative groups improved their maximal hip extension strength by 0.61 N·m/kg (IQR, 0.42-0.80 N·m/kg) and 0.62 N·m/kg (IQR, 0.13-1.10 N·m/kg), respectively. Their maximal knee flexion strength at 30° improved by 0.52 N·m/kg (IQR, 0.29-0.74 N·m/kg) and 0.32 N·m/kg (IQR, 0.12-0.52 N·m/kg) and their maximal knee flexion strength at 90° improved by 0.28 N·m/kg (IQR, 0.19-0.37 N·m/kg) and 0.22 N·m/kg (IQR, 0.02-0.41 N·m/kg). At the 12-month follow-up, the side-to-side difference in maximal muscle strength was 6% and 7%, respectively, during hip extension and 19% to 25% and 16% to 17%, respectively, during knee flexion. Conclusion: Twelve months after treatment of proximal hamstring avulsion, good clinical outcomes were seen when using a shared decision strategy regardless of whether the strategy led to surgical or conservative treatment.

Short-term alcohol abstinence prior to liver transplantation and impact on rejection

Background & AimsAlcohol-associated liver disease (ALD) is a leading indication for liver transplant (LT). Historically, centers implemented 6-month abstinence periods prior to LT listing; however, the impact of this abstinence time on post-transplant rejection outcomes is unclear. This study evaluated if short-term abstinence is associated with increased rejection post-LT. MethodsThis single-center, retrospective, cohort included adult LT recipients from 11/1/2015 to 7/21/2021 with a primary indication of ALD. Patients were grouped by pre-transplant abstinence time of <6 or ≥6-months. The primary endpoint was biopsy proven acute rejection (BPAR) at 12-months post-LT. Secondary endpoints were infection, alcohol relapse, patient and graft survival at 12-months. ResultsOverall, 228 LT recipients met inclusion criteria (<6-months: n = 130; ≥6-months: n = 98). Patients with <6-months of abstinence were younger, had higher MELD scores, and more renal replacement therapy needs. Incidence of BPAR within 12 months of LT was 28 % in the <6-month group vs. 18 % in the ≥6-month group (p = 0.078). Tacrolimus initiation was lower at 7 days post-LT in the <6-month group (77% vs. 89 %; p = 0.029). Delay in tacrolimus initiation past 7 days post-LT was associated with greater BPAR (35% vs. 12 %; p = 0.0001). Increased bloodstream infections (21% vs. 7 %; p = 0.04) and CMV DNAemia (31% vs. 7 %; p = 0.0008) were seen in the <6-month group. Patient and graft survival was similar between groups. ConclusionsAbstinence time of <6-months was not associated with more BPAR within 12-months post-LT. The <6-month group was sicker at time of LT, which correlates to lower tacrolimus exposure early post-LT and heightened incidence of bacteremia and CMV viremia. Given the high acuity of the <6-month abstinence group, the risk of BPAR must be closely balanced with infection risk.

Effect of Silane-Containing Adhesives on Repair Bond Strength between Fresh and Aged Composite Materials-A Pilot Study.

This study investigated the effects of different surface treatments and a silane-containing adhesive on the repair bond strength between fresh and aged resin composites. A total of 140 composite specimens were prepared and aged for 24 h or 4 months. Each group was subdivided into seven subgroups (n = 10) depending on the surface treatment (no surface treatment (NT), sandblasting (SAND), or Sof-lex coarse disc (DISC)) in combination with the use of the silane-containing adhesive ScotchBond Universal Plus (SBU) or an adhesive without silane Prime&Bond Universal (P&B). The same composite was used for the repair as for the primary specimen. Specimens were dark stored in distilled water at 37 °C for 28 days. Shear bond strength was tested at a crosshead speed of 0.5 mm/min. The Kruskal-Wallis test with Bonferroni's post-hoc adjustment (α = 0.05) and the Mann-Whitney U-test were used for the statistical analysis. The results are shown as the median with the interquartile range. The highest bond strength (MPa) was achieved after 24 h in the DISC+P&B (20.39(16.85-28.83)). In the fresh 24 h group, the SAND+P&B (12.25(8.28-15.05)) and DISC+SBU (18.37(15.16-21.29)) were statistically similar. In the 4-month groups, both adhesives and surface treatments performed similarly. The NT, SAND, and DISC groups without adhesives had the lowest bond strength. In the repair of fresh or aged composite, the silane-containing adhesive SBU was not superior to the adhesive without the silane (P&B).

Digital behaviour change intervention for weight loss maintenance in adults with obesity: a feasibility pilot study of eCHANGE

ABSTRACT Successful weight maintenance after weight loss is challenging. Digital interventions may facilitate behaviour change to prevent weight regain, however little is known about the acceptance and use of digital interventions in support of weight maintenance. This mixed methods study aims to evaluate user experiences, system use, and preliminary efficacy of eCHANGE, an application based self-management intervention for weight loss maintenance. A 3-month multi-site single group feasibility pilot study was conducted among adults (N = 60) with BMI ≥30 kg/m2, aiming to maintain weight after weight loss of ≥8%. User experiences and system use were examined through validated questionnaires, system use log data, and individual interviews (n = 15). Preliminary efficacy testing included body weight and patient reported outcome measures. Participants rated eCHANGE usability and usefulness as good in support of weight maintenance, with variation in usage. Analysis indicated that higher behavioural engagement scores were statistically significantly associated with frequency of technology usage. Weight loss was maintained by 83% of the participants at 3-months (i.e. defined as weight change of <3% of baseline body weight (kg)). Digital interventions, combining persuasive system design principles and behaviour change techniques, supporting self-regulation and maintenance of health behaviours, have the potential to facilitate weight maintenance after weight loss. Trial Registration: ClinicalTrials.gov NCT04537988 https://clinicaltrials.gov/ct2/show/NCT04537988

Evolution of bacterial flora in raw yak milk and its effect on quality characteristics during frozen storage

Due to the scarcity of yak milk in Tibetan areas, local herders primarily use traditional freezing methods for preservation. However, the extent of microbial contamination in raw yak milk during frozen storage and its impact on milk quality remains largely unexplored. This study analyzed the changes in bacterial populations and quality of raw yak milk stored at −18 °C for 6 months. The results indicated that, compared to fresh milk, the freshness of yak milk showed no significant change after 2 months of frozen storage (P > 0.05). After 4 months, the bacterial diversity of flora in yak milk increased significantly, with Pseudomonas and Acinetobacter emerging as the dominant psychrophilic bacteria. Correspondingly, the expression of metabolic pathways related to quality deterioration increased, with a significant increase in physicochemical indicators such as acidity, proteolysis degree, acid value and fat oxidation degree (P < 0.05). Extending the frozen storage to 6 months resulted in a slight but no significant decrease in bacterial diversity, with no significant difference in quality deterioration compared to the 4-month group (P > 0.05). Correlation analysis further revealed that Acinetobacter and Psychrobacter were significantly positively correlated with quality deterioration of frozen milk (P < 0.05). In summary, when frozen for more than 4 months, raw yak milk exhibited the highest bacterial diversity and predicted the most abundant metabolic pathways, with dominant psychrophilic bacteria massive proliferation leading to a decline in quality and safety.

Dynamic change of lymphocytes associated with short-term prognosis in anti-MDA5-positive dermatomyositis with interstitial lung disease: a multicenter retrospective study

Lymphopenia is a unique manifestation of anti-MDA5 positive dermatomyositis with interstitial lung disease (MDA5 + DM-ILD). This study aimed to investigate the relationship between dynamic changes in peripheral lymphocytes and short-term prognosis in patients of MDA5 + DM-ILD. Two hundred sixty-three MDA5 + DM-ILD patients were divided into different groups according to lymphocyte count and death or survival within 1 month, then the differences in clinical features and outcomes were compared. Associations between lymphocytes and risk of death within 1 month were also investigated in different lymphocyte groups using Cox proportional hazard models. A generalized additive mixed model (GAMM) was established to analyze the dynamic changes of lymphocytes in the death 1-month group. Lymphocytes of the patients who died within 1 month were significantly lower than survivors by different lymphocyte grouping methods, and the total lymphocytes showed a gradually decreasing trend in non-survivors. And the difference between survivors and non-survivors was more obvious over time. The lowest tertile of baseline lymphocytes as a reference, the hazard ratios for death within 1 month in the highest tertile were 0.497 (95% CI 0.26–0.949, P for trend = 0.033) after adjustment for potential confounders. GAMM analysis found a mean daily decrease of lymphocytes (0.034 × 10^9/L) after admission in death 1-month patients. Low baseline lymphocytes and gradually declined lymphocytes are both associated with a high risk of death within 1 month. However dynamic changes in lymphocytes can better reflect the disease status and better predict the short-term prognosis than baseline lymphocytes in MDA5 + DM-ILD patients.Key points•Low baseline lymphocytes and gradually decreased trend along time correlated with poor short-term prognosis in MDA5 + DM-ILD patients.•Dynamic changes of lymphocytes can better reflect the disease status and better predict the 1-month prognosis than baseline lymphocytes in MDA5 + DM-ILD patients.•Generalized additive mixed model (GAMM) analysis found that in 1-month non-survivors, peripheral blood lymphocytes decreased by 0.034 × 10^9/L per day, while the lymphocytes in survivors gradually increased.

Duration of Dual Antiplatelet Therapy after Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery Stenosis: 6 versus 12 Months.

Background/Objectives: For patients with percutaneous coronary intervention (PCI) of an unprotected left main coronary artery (uLMCA) stenosis, the optimal duration of dual antiplatelet therapy (DAPT) remains a matter of debate. The purpose of this study was to compare clinical outcomes of 6- versus 12-month DAPT duration in patients with PCI of an uLMCA and stable angina. Methods: In this retrospective analysis, we included consecutive patients of our centre who underwent PCI of uLMCA stenosis for stable angina and who received DAPT with acetylsalicylic acid and clopidogrel for either 6 or 12 months. The primary endpoint was the composite of all-cause mortality, myocardial infarction, and target lesion revascularization at one year. Secondary endpoints included individual components of the primary endpoint, definite/probable stent thrombosis, and bleeding. Clinical outcomes were assessed by unadjusted analysis and by inverse probability of treatment weighting (IPTW). Results: Out of 984 included patients, 339 (34.5%) received DAPT for 6 months and 645 (65.5%) for 12 months. The primary endpoint occurred in 51 patients (15.2%) in the 6-month group and in 104 (16.3%) in the 12-month group (p = 0.674). Incidences of stent thrombosis (0.9% versus 0.3%, p = 0.224) and BARC 3,4,5 bleeding (6% versus 5.8%, p = 0.808) were also comparable in both groups. We found no significant differences in the primary endpoint and its components or BARC 3,4,5 bleeding between 6 and 12 months. Conclusions: Our findings do not support the extension of DAPT beyond 6 months after PCI for uLMCA in patients with stable angina.

Effect of different growth hormone pretreatment times in assisted reproductive therapy for patients with diminished ovarian reserve: A retrospective pilot cohort study.

This study aimed to evaluate the effect of different growth hormone (GH) pretreatment times in assisted reproductive therapy in patients with diminished ovarian reserve (DOR). A retrospective pilot cohort analysis was performed on patients with DOR receiving GH pretreatment in the Assisted Reproduction Unit of Sir Run Run Shaw Hospital. A total of 1459 patients met the criteria and were divided into four groups according to GH pretreatment time as follows: 53 were in the 2-month pretreatment group (GH1), 400 were in the 1-month pretreatment group (GH2), 414 were in the ovulation induction period pretreatment group (GH3), and 592 were in the non-GH pretreatment group (control group). In addition, GH1, GH2, and GH3 were combined in the GH pretreatment group. Baseline characteristics and treatment outcomes were compared between the groups. The number of oocytes retrieved in the GH pretreatment, GH1, GH2, and GH3 groups was significantly higher than that in the control group (all P < .01). The numbers of oocytes retrieved in the GH1 and GH2 groups were similar but were nominally higher than those in the GH3 group. Estradiol concentrations in the GH pretreatment, GH2, and GH3 groups were significantly higher than those in the control group on the day of human chorionic gonadotropin injection (all P < .01). In the GH1 group, 22 patients had >1 assisted reproductive therapy cycle (non-GH pretreatment) before GH pretreatment, and the number of oocytes retrieved in the GH pretreatment cycle was higher than that in the non-GH pretreatment cycle, but this was not significant. These findings suggest that the GH pretreatment time was appropriately prolonged, and the number of oocytes retrieved nominally increased. In patients with DOR, GH pretreatment improved treatment outcomes. More than 1 month of GH pretreatment did not increase the number of oocytes retrieved.

Utility of the modified Ottawa score for identification of more preferable candidates of extended anticoagulation therapy in cancer-associated isolated distal deep vein thrombosis: insight from the ONCO DVT Study

BackgroundThe ONCO DVT study (Edoxaban for 12 Months Versus 3 Months in Patients With Cancer With Isolated Distal Deep Vein Thrombosis) revealed superiority of 12-month relative to 3-month edoxaban treatment for the thrombotic risk in cancer-associated isolated distal deep vein thrombosis. However, it is unknown whether the superiority could be common in different modified Ottawa score subgroups. ObjectivesTo identify more preferable candidates for extended anticoagulation in patients with cancer-associated isolated distal deep vein thrombosis using the modified Ottawa score. MethodsIn this post-hoc subgroup analysis of the ONCO DVT study, we stratified 601 patients into the low (≤−1, N = 126), intermediate (0, N = 323), and high (≥1, N = 152) modified Ottawa score subgroups and compared clinical outcomes between the 12-month and 3-month edoxaban treatment groups. ResultsThe cumulative incidence of symptomatic recurrent venous thromboembolism or venous thromboembolism–related death was not different between the 12-month and 3-month edoxaban treatment groups in the low score subgroup (0.0% vs 2.2%), whereas it was lower in the 12-month than in the 3-month edoxaban treatment group in the intermediate (0.8% vs 7.6%) and high (3.1% vs 15.6%) score subgroups. There were no significant differences in the cumulative incidences of the major bleeding between the 12-month and 3-month edoxaban treatment groups in the low (10.1% vs 7.6%), intermediate (8.8% vs 5.0%), and high (13.9% vs 12.6%) score subgroups. ConclusionA 12-month compared with 3-month edoxaban treatment showed a lower risk of thrombotic events in patients with cancer-associated isolated distal deep vein thrombosis in the intermediate and high modified Ottawa score subgroups but not in the low score subgroup, suggesting a limited benefit of extended anticoagulation therapy beyond 3 months in patients with low modified Ottawa score.

An acceptance and commitment therapy and mindfulness group intervention for the psychological and physical well-being of adults with body mass indexes in the overweight or obese range: The Mind&Life randomized controlled trial

This trial aimed to assess the effect of an acceptance and commitment therapy (ACT) and mindfulness-based intervention on the various psychological and physical issues associated with obesity. A parallel group randomized controlled trial was conducted with 142 adults with body mass indexes in the overweight or obesity range seeking treatment. Participants were assigned either to the ACT and mindfulness-based group intervention (Mind&Life intervention) plus treatment as usual (TAU) or the TAU-only condition. Individuals receiving the Mind&Life intervention with TAU showed more adherence to the Mediterranean diet, and greater decrease in external eating, weight, and visceral fat both at posttreatment and at 6-month follow-up. Moreover, they displayed a greater reduction in total protein and animal protein intake and GPT enzymes level. By 6-month follow-up, the Mind&Life group experienced a lower impact of weight on quality of life than TAU participants. However, Mind&Life intervention completers showed greater restrained eating levels at follow-up. Overall, this study suggests that an ACT and mindfulness-based group intervention could produce improvements in the impact of weight on quality of life, some eating behaviors, dietary habits, and weight and body composition parameters of people facing weight-related challenges.