Acupuncture for poststroke coma: A systematic review and meta-analysis.

BACKGROUND: Despite being widely applied in clinical practice, the wake-promoting effect of acupuncture in poststroke coma patients remains controversial. OBJECTIVE: This study aimed to evaluate the efficacy of acupuncture for the treatment of poststroke coma. METHODS: Randomized controlled trials (RCTs) of acupuncture for treating poststroke coma were identified in PubMed, Cochrane Library, EMBASE, CNKI, WanFang and VIP up to 25 November 2023. The main outcomes were Glasgow Coma Scale (GCS) score, National Institute of Health Stroke Scale (NIHSS) score, awakening ratio and clinically effective ratio. Stata 17 and Review Manager 5.4 software were used for mate analysis. RESULTS: A total of 34 RCTs involving 2757 patients were included. GCS (WMD = 1.78; 95% CI: 1.35 to 2.21) and NIHSS score (WMD = -2.84; 95% CI: -3.84 to -1.84) were significantly increased in acupuncture group compared with control group. Acupuncture combined with routine treatment may be better than routine treatment in improving the awakening ratio (RR= 1.65; 95% CI: 1.24 to 2.91) and the clinically effective ratio (RR= 1.20; 95% CI: 1.13 to 1.27). Some methodological flaws were identified in the included studies, including non-implementation of blinding, inappropriate disease assessment and heterogeneous interventions. CONCLUSIONS: The existing evidence suggests that acupuncture combined with conventional treatment may be an effective treatment for poststroke coma patients. In the meantime, more high-quality RCTs are needed to demonstrate these findings due to methodological weaknesses like randomization, blinding, heterogeneous interventions and long-term follow-up.

The effects of plum products consumption on lipid profile in adults: A systematic review and dose-response meta-analysis.

Consumption of plum does not yet clearly affect the lipid profile. To ascertain the advantages of plum consumption on adult lipid profiles, we conducted a systematic review and meta-analysis. We used pertinent keywords to search the databases of PubMed, Scopus, and ISI Web of Science up to November 10th, 2022, in order to find trials that were eligible. According to the analyses, eating plum significantly lowers LDL levels compared to controls (WMD: -12.50 mg/dL, 95% CI: -22.06, -2.94, p = .010). Although plum consumption did not result in significant changes in TG (WMD: 0.56 mg/dL, 95% CI: -6.02, 7.15, p = .866), TC (WMD: -12.35 mg/dL, 95% CI: -25.05, 0.37, p = .057), and HDL concentrations (WMD: -0.39 mg/dL, 95% CI: -4.69, 3.89, p = .855) compared to the control group. Intake of plums, particularly the intervention type of dried plums, significantly decreased TC levels in unhealthy subjects, according to subgroup analysis. The consumption of plums had a notably statistically significant effect on LDL levels when the intervention type was dried plum and unhealthy subjects were enrolled. Due to the very low to moderate quality of meta-evidence, to show how eating plum improves lipid profile, further high-quality research are still essential.

A Digital Cognitive-Physical Intervention for Attention-Deficit/Hyperactivity Disorder: Randomized Controlled Trial.

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders among children. Pharmacotherapy has been the primary treatment for ADHD, supplemented by behavioral interventions. Digital and exercise interventions are promising nonpharmacologic approaches for enhancing the physical and psychological health of children with ADHD. However, the combined impact of digital and exercise therapies remains unclear. OBJECTIVE: The aim of this study was to determine whether BrainFit, a novel digital intervention combining gamified cognitive and exercise training, is efficacious in reducing ADHD symptoms and executive function (EF) among school-aged children with ADHD. METHODS: This 4-week prospective randomized controlled trial included 90 children (6-12 years old) who visited the ADHD outpatient clinic and met the diagnostic criteria for ADHD. The participants were randomized (1:1) to the BrainFit intervention (n=44) or a waitlist control (n=46) between March and August 2022. The intervention consisted of 12 30-minute sessions delivered on an iPad over 4 weeks with 3 sessions per week (Monday, Wednesday, and Friday after school) under the supervision of trained staff. The primary outcomes were parent-rated symptoms of attention and hyperactivity assessed according to the Swanson, Nolan, and Pelham questionnaire (SNAP-IV) rating scale and EF skills assessed by the Behavior Rating Inventory of Executive Function (BRIEF) scale, evaluated pre and post intervention. Intention-to-treat analysis was performed on 80 children after attrition. A nonparametric resampling-based permutation test was used for hypothesis testing of intervention effects. RESULTS: Among the 145 children who met the inclusion criteria, 90 consented and were randomized; ultimately, 80 (88.9%) children completed the study and were included in the analysis. The participants' average age was 8.4 (SD 1.3) years, including 63 (78.8%) male participants. The most common ADHD subtype was hyperactive/impulsive (54/80, 68%) and 23 (29%) children had severe symptoms. At the endpoint of the study, the BrainFit intervention group had a significantly larger improvement in total ADHD symptoms (SNAP-IV total score) as compared to those in the control group (ß=-12.203, 95% CI -17.882 to -6.523; P<.001), owing to lower scores on the subscales Inattention (ß=-3.966, 95% CI -6.285 to -1.647; P<.001), Hyperactivity/Impulsivity (ß=-5.735, 95% CI -8.334 to -3.137; P<.001), and Oppositional Defiant Disorder (ß=-2.995, 95% CI -4.857 to -1.132; P=.002). The intervention was associated with significant reduction in the Metacognition Index (ß=-6.312, 95% CI -10.973 to -1.650; P=.006) and Global Executive Composite (ß=-5.952, 95% CI -10.214 to -1.690; P=.003) on the BRIEF. No severe intervention-related adverse events were reported. CONCLUSIONS: This novel digital cognitive-physical intervention was efficacious in school-age children with ADHD. A larger multicenter effectiveness trial with longer follow-up is warranted to confirm these findings and to assess the durability of treatment effects. TRIAL REGISTRATION: Chinese Clinical Trial Register ChiCTR2300070521; https://www.chictr.org.cn/showproj.html?proj=177806.

Pulmonary artery pressure monitoring in chronic heart failure: effects across clinically relevant subgroups in the MONITOR-HF trial.

BACKGROUND AND AIMS: In patients with chronic heart failure (HF), the MONITOR-HF trial demonstrated the efficacy of pulmonary artery (PA)-guided HF therapy over standard of care in improving quality of life and reducing HF hospitalizations and mean PA pressure. This study aimed to evaluate the consistency of these benefits in relation to clinically relevant subgroups. METHODS: The effect of PA-guided HF therapy was evaluated in the MONITOR-HF trial among predefined subgroups based on age, sex, atrial fibrillation, diabetes mellitus, left ventricular ejection fraction, HF aetiology, cardiac resynchronisation therapy, and implantable cardioverter defibrillator. Outcome measures were based upon significance in the main trial and included quality of life, clinical, and PA pressure endpoints, and were assessed for each subgroup. Differential effects in relation to the subgroups were assessed with interaction terms. Both unadjusted and multiple testing adjusted interaction terms were presented. RESULTS: The effects of PA monitoring on quality of life, clinical events, and PA pressure were consistent in the predefined subgroups, without any clinically relevant heterogeneity within or across all endpoint categories (all adjusted interaction P-values were nonsignificant). In the unadjusted analysis of the primary endpoint quality-of-life change, weak trends towards a less pronounced effect in older patients (Pinteraction = 0.03; adjusted Pinteraction = 0.33) and diabetics (Pinteraction = 0.01; adjusted Pinteraction = 0.06) were observed. However, these interaction effects did not persist after adjusting for multiple testing. CONCLUSIONS: This subgroup analysis confirmed the consistent benefits of PA-guided HF therapy observed in the MONITOR-HF trial across clinically relevant subgroups, highlighting its efficacy in improving quality of life, clinical, and PA pressure endpoints in chronic HF patients.

Efficacy and Safety of Bufei Jiedu Granules in Treating Multidrug-Resistant Pulmonary Tuberculosis: A Multi-center, Double-Blinded and Randomized Controlled Trial.

OBJECTIVE: To assess the efficacy and safety of Bufei Jiedu (BFJD) ranules as adjuvant therapy for patients with multidrug-resistant pulmonary tuberculosis (MDR-PTB). METHODS: A large-scale, multi-center, double-blinded, and randomized controlled trial was conducted in 18 sentinel hospitals in China from December 2012 to December 2016. A total of 312 MDR-PTB patients were randomly assigned to BFJD Granules or placebo groups (1:1) using a stratified randomization method, which both received the long-course chemotherapy regimen for 18 months (6 Am-Lfx-P-Z-Pto, 12 Lfx-P-Z-Pto). Meanwhile, patients in both groups also received BFJD Granules or placebo twice a day for a total of 18 months, respectively. The primary outcome was cure rate. The secondary outcomes included time to sputum-culture conversion, changes in lung cavities and quality of life (QoL) of patients. Adverse reactions were monitored during and after the trial. RESULTS: A total of 216 cases completed the trial, 111 in the BFJD Granules group and 105 in the placebo group. BFJD Granules, as an adjuvant treatment, increased the cure rate by 13.6% at the end of treatment, compared with the placebo (58.4% vs. 44.8%, P=0.02), and accelerated the median time to sputum-culture conversion (5 months vs. 11 months). The cavity closure rate of the BFJD Granules group (50.6%, 43/85) was higher than that of the placebo group (32.1%, 26/81; P=0.02) in patients who completed the treatment. At the end of the intensive treatment, according to the 36-item Short Form, the BFJD Granules significantly improved physical functioning, general health, and vitality of patients relative to the placebo group (all P<0.01). Overall, the death rates in the two groups were not significantly different; 5.1% (8/156) in the BFJD Granules group and 2.6% (4/156) in the placebo group. CONCLUSIONS: Supplementing BFJD Granules with the long-course chemotherapy regimen significantly increased the cure rate and cavity closure rates, and rapidly improved QoL of patients with MDR-PTB (Registration No. ChiCTR-TRC-12002850).

Building a Bridge to Community: A Pragmatic Randomized Trial Examining a Combined Physical Therapy and Resistance Exercise Intervention for People after Head and Neck Cancer.

BACKGROUND: Established barriers to general exercise and physical activity among individuals with head and neck cancer include dry mouth, difficulty eating, weight loss, fear of injury, comorbidities, and treatment-related symptoms of pain and fatigue. METHODS/DESIGN: A 12-week pragmatic randomized controlled trial was conducted followed by an optional supported exercise transition phase. Eligible participants were individuals with head and neck cancers who had undergone surgery and/or radiation therapy to lymph node regions in the neck. Participants were randomized to a comparison group involving a shoulder and neck physiotherapeutic exercise protocol, or to a combined experimental group comprising the shoulder and neck physiotherapeutic exercise protocol and lower-body resistance exercise training. The primary outcome of this study was fatigue-related quality of life. RESULTS: Sixty-one participants enrolled, 59 (97%) completed the randomized trial phase, 55 (90%) completed the 24-week follow-up, and 52 (85%) completed the one-year follow-up. Statistically significant between-group differences were found in favor of the combined experimental group for the fatigue-related quality of life, fitness outcomes, and overall physical activity. Paired comparisons confirmed significant within-group improvements for both groups from baseline to one-year follow-up across most outcomes. DISCUSSION: A group-based combined physiotherapeutic and lower-body resistance exercise program was feasible and effective. Findings are limited to individuals who had undergone a surgical neck dissection procedure. Given the complexity of head and neck cancer, further pragmatic interdisciplinary research is warranted.

Systematic analysis of approaches used in cardiac arrest trials to inform relatives about trial enrolment of non-surviving patients.

BACKGROUND: The recruitment of patients to emergency research studies without the requirement for prior informed consent has furthered the conduct of randomised studies in cardiac arrest. Frameworks enabling this vary around the world depending on local legal or ethical requirements. When an enrolled patient does not survive, researchers may take one of three approaches to inform relatives of their enrolment: a direct (active) approach, providing information indirectly (passively) and inviting relatives to seek further information if they choose, or providing no information about the trial (no attempt). Previous studies have described experiences of US researchers' active approach but there is little known about approaches elsewhere.We aimed to conduct a structured investigation of methods used in cardiac arrest trials to provide information about trial enrolment to relatives of non-surviving patients. METHODS: We systematically searched trial registries to identify randomised clinical trials that recruited cardiac arrest patients. Trials were eligible for inclusion if they recruited adults during cardiac arrest (or within 1 hour of return of spontaneous circulation) between 2010 and 2022 (in the decade prior to study conception). We extracted data from trial registries and, where relevant, published papers and protocols. Investigators were contacted and asked to describe the style, rationale and timing of approach to relatives of non-surviving patients. We present descriptive statistics. RESULTS: Our trial registry search identified 710 unique trials, of which 108 were eligible for inclusion. We obtained information from investigators for 64 (62%) trials. Approximately equal numbers of trials attempted to actively inform relatives of non-survivors (n=28 (44% (95% CI; 31% to 57%))), or made no attempt (n=25 (39% (95% CI; 27% to 52%))). The remaining studies provided general information about the trial to relatives but did not actively inform them (n=11 (17% (95% CI; 8% to 29%))). CONCLUSIONS: There is wide variability in the approach taken to informing relatives of non-surviving patients enrolled in cardiac arrest randomised clinical trials.

Evaluating the effect of a mobile-based symptom monitoring system for improving physical function in patients with cancer during chemotherapy: study protocol for a multicentre randomised controlled trial.

INTRODUCTION: Symptoms due to chemotherapy are common in patients with cancer. Cancer-related symptoms are closely associated with the deterioration of physical function which can be associated with decreased quality of life and increased mortality. Thus, timely symptom identification is critical for improving cancer prognosis and survival. Recently, remote symptom monitoring system using digital technology has demonstrated its effects on symptom control or survival. However, few studies examined whether remote monitoring would contribute to retaining physical function among patients with cancer. Therefore, this study aimed to evaluate the effectiveness of mobile-based symptom monitoring in improving physical function among patients with cancer under chemotherapy. METHODS AND ANALYSIS: This study is a multicentre, open-label, parallel-group, randomised controlled trial. We will recruit 372 patients at three tertiary hospitals located in Seoul, South Korea. Study participants will be randomly assigned to either an intervention group receiving the ePRO-CTCAE app and a control group receiving routine clinical practice only. The primary outcome is changes in physical function from commencement to completion of planned chemotherapy. A linear mixed model will be performed under the intention-to-treat principle. The secondary outcomes include physical activity level; changes in pain interference; changes in depressive symptom; unplanned clinical visits; additional medical expenditure for symptom management; completion rate of planned chemotherapy; changes in symptom burden and health-related quality of life; and 1-year overall mortality. ETHICS AND DISSEMINATION: The study has been approved by the institutional review board and ethics committee at the three university hospitals involved in this trial. Written informed consent will be obtained from all the participants. The results of the trial will be submitted for publication in peer-reviewed academic journals and disseminated through relevant literatures. TRIAL REGISTRATION NUMBER: KCT0007220.

Effectiveness and cost-effectiveness of a 12-month automated text message intervention for weight management in postpartum women with overweight or obesity: protocol for the Supporting MumS (SMS) multisite, parallel-group, randomised controlled trial.

INTRODUCTION: The reproductive years can increase women's weight-related risk. Evidence for effective postpartum weight management interventions is lacking and engaging women during this life stage is challenging. Following a promising pilot evaluation of the Supporting MumS intervention, we assess if theory-based and bidirectional text messages to support diet and physical activity behaviour change for weight loss and weight loss maintenance, are effective and cost-effective for weight change in postpartum women with overweight or obesity, compared with an active control arm receiving text messages on child health and development. METHODS AND ANALYSIS: Two-arm, parallel-group, assessor-blind randomised controlled trial with cost-effectiveness and process evaluations. Women (n=888) with body mass index (BMI) ≥25 kg/m2 and within 24 months of giving birth were recruited via community and National Health Service pathways through five UK sites targeting areas of ethnic and socioeconomic diversity. Women were 1:1 randomised to the intervention or active control groups, each receiving automated text messages for 12 months. Data are collected at 0, 6, 12 and 24 months. The primary outcome is weight change at 12 months from baseline, compared between groups. Secondary outcomes include weight change (24 months) and waist circumference (cm), proportional weight gain (>5 kg), BMI (kg/m2), dietary intake, physical activity, infant feeding and mental health (6, 12 and 24 months, respectively). Economic evaluation examines health service usage and personal expenditure, health-related quality of life and capability well-being to assess cost-effectiveness over the trial and modelled lifetime. Cost-utility analysis examines cost per quality-adjusted life-years gained over 24 months. Mixed-method process evaluation explores participants' experiences and contextual factors impacting outcomes and implementation. Stakeholder interviews examine scale-up and implementation. ETHICS AND DISSEMINATION: Ethical approval was obtained before data collection (West of Scotland Research Ethics Service Research Ethics Committee (REC) 4 22/WS/0003). Results will be published via a range of outputs and audiences. TRIAL REGISTRATION NUMBER: ISRCTN16299220.

Impacts of an abbreviated personal agency training with refugee women and their male partners on economic empowerment, gender-based violence, and mental health: a randomized controlled trial in Rwanda.

INTRODUCTION: We assessed the impact of a personal agency-based training for refugee women and their male partners on their economic and social empowerment, rates of intimate partner violence (IPV), and non-partner violence (NPV). METHODS: We conducted an individually randomized controlled trial with 1061 partnered women (aged 18-45) living in a refugee camp in Rwanda. Women received two days of training, and their partners received one day of training. The follow-up survey where all relevant outcomes were assessed was carried out at 6-9 months post-intervention. RESULTS: At follow up, women in the intervention arm were more likely to report partaking in income generating activities (aIRR 1.27 (1.04-1.54), p < 0.05) and skill learning (aIRR 1.59 (1.39-1.82), p < 0.001) and reported a reduction in experience of physical or sexual NPV in the past six months (aIRR 0.65 (0.39-1.07), p < 0.09). While improved, no statistically significant impacts were seen on physical or sexual IPV (aIRR 0.80 (0.58-1.09), p = 0.16), food insecurity (ß 0.98 (0.93 to 1.03), p = 0.396), or clean cookstove uptake (aIRR 0.95 (0.88 to 1.01), p = 0.113) in the past six months. We found statistically significant reduction in physical and sexual IPV amongst those experiencing IPV at baseline (aIRR 0.72 (0.50 to 1.02), p < 0.07). Small improvements in self-efficacy scores and our indicator of adapting to stress were seen in the intervention arm. Some challenges were also seen, such as higher prevalence of probable depression and/or anxiety (aIRR 1.79 (1.00-3.22), p = 0.05) and PTSD (aIRR 2.07 (1.10-3.91), p < 0.05) in the intervention arm compared to the control arm. CONCLUSION: Our findings echo previous research showing personal agency training can support economic well-being of women. We also find potentially promising impacts on gender-based violence. However, there is some evidence that integration of evidence-based mental health support is important when enhancing agency amongst conflict-affected populations. TRIAL REGISTRATION NUMBER: The trial was registered with ClinicalTrials.gov, Identifier: NCT04081441 on 09/09/2019.

Effect of Rural Trauma Team Development on the Outcomes of Motorcycle Accident-Related Injuries (Motor Registry Project): Protocol for a Multicenter Cluster Randomized Controlled Trial.

BACKGROUND: Injury is a global health concern, and injury-related mortality disproportionately impacts low- and middle-income countries (LMICs). Compelling evidence from observational studies in high-income countries shows that trauma education programs, such as the Rural Trauma Team Development Course (RTTDC), increase clinician knowledge of injury care. There is a dearth of such evidence from controlled clinical trials to demonstrate the effect of the RTTDC on process and patient outcomes in LMICs. OBJECTIVE: This multicenter cluster randomized controlled clinical trial aims to examine the impact of the RTTDC on process and patient outcomes associated with motorcycle accident-related injuries in an African low-resource setting. METHODS: This is a 2-arm, parallel, multi-period, cluster randomized, controlled, clinical trial in Uganda, where rural trauma team development training is not routinely conducted. We will recruit regional referral hospitals and include patients with motorcycle accident-related injuries, interns, medical trainees, and road traffic law enforcement professionals. The intervention group (RTTDC) and control group (standard care) will include 3 hospitals each. The primary outcomes will be the interval from the accident to hospital admission and the interval from the referral decision to hospital discharge. The secondary outcomes will be all-cause mortality and morbidity associated with neurological and orthopedic injuries at 90 days after injury. All outcomes will be measured as final values. We will compare baseline characteristics and outcomes at both individual and cluster levels between the intervention and control groups. We will use mixed effects regression models to report any absolute or relative differences along with 95% CIs. We will perform subgroup analyses to evaluate and control confounding due to injury mechanisms and injury severity. We will establish a motorcycle trauma outcome (MOTOR) registry in consultation with community traffic police. RESULTS: The trial was approved on August 27, 2019. The actual recruitment of the first patient participant began on September 01, 2019. The last follow-up was on August 27, 2023. Posttrial care, including linkage to clinical, social support, and referral services, is to be completed by November 27, 2023. Data analyses will be performed in Spring 2024, and the results are expected to be published in Autumn 2024. CONCLUSIONS: This trial will unveil how a locally contextualized rural trauma team development program impacts organizational efficiency in a continent challenged with limited infrastructure and human resources. Moreover, this trial will uncover how rural trauma team coordination impacts clinical outcomes, such as mortality and morbidity associated with neurological and orthopedic injuries, which are the key targets for strengthening trauma systems in LMICs where prehospital care is in the early stage. Our results could inform the design, implementation, and scalability of future rural trauma teams and trauma education programs in LMICs. TRIAL REGISTRATION: Pan African Clinical Trials Registry (PACTR202308851460352); https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25763. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55297.

Final 5-year report of BIONYX comparing the thin-composite wire-strut zotarolimus-eluting stent versus ultrathin-strut sirolimus-eluting stent.

BACKGROUND: The BIONYX randomized trial is the first study to evaluate the Resolute Onyx durable polymer-coated zotarolimus-eluting stent (ZES) in all-comers. Furthermore, it is the first trial to assess safety and efficacy of this stent versus the Orsiro biodegradable-polymer sirolimus-eluting stent (SES) in all-comers, paying particular attention to patients with diabetes. It has previously shown promising results until 3 years of follow-up. AIMS: We aimed to assess long-term clinical outcome after percutaneous coronary intervention (PCI) with Onyx ZES versus Orsiro SES at 5-year follow-up. METHODS: The main composite endpoint was target vessel failure (TVF): cardiac death, target vessel myocardial infarction, or target vessel revascularization. Time to primary and secondary endpoints was assessed using Kaplan-Meier methods, applying the log-rank test for between-group comparison. RESULTS: Follow-up was available in 2414/2488 (97.0%) patients. After 5 years, TVF showed no significant difference between Onyx ZES and Orsiro SES (12.7% vs. 13.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] [0.75-1.17], plog-rank = 0.55). Landmark analysis between 3- and 5-year follow-up found a lower target lesion revascularization rate for Onyx ZES (1.1% vs. 2.4%, HR 0.47, 95% CI [0.24-0.93], plog-rank = 0.026). A prespecified subgroup analysis showed no significant between-stent difference in clinical outcome among patients with diabetes. After treatment with Onyx ZES, patients aged ≥75 years had significantly lower rates of TVF (13.8% vs. 21.9%, HR 0.60, 95% CI [0.39-0.93], plog-rank = 0.023). CONCLUSIONS: The final 5-year analysis of the randomized BIONYX trial showed favorable and similar long-term outcomes of safety and efficacy for Onyx ZES and Orsiro SES in both all-comers and patients with diabetes.

GATA6 identifies an immune-enriched phenotype linked to favorable outcomes in patients with pancreatic cancer undergoing upfront surgery.

This study underscores GATA6's role in distinguishing classical and basal-like pancreatic ductal adenocarcinoma (PDAC) phenotypes. Retrospective studies associate GATA6 immunohistochemistry (IHC) expression with survival outcomes, warranting prospective validation. In a prospective treatment-naive cohort of patients with resected PDAC, GATA6 IHC proves a prognostic discriminator, associating high GATA6 expression with extended survival and the classical PDAC phenotype. However, GATA6's prognostic significance is numerically lower after gemcitabine-based neoadjuvant chemoradiotherapy compared to its significance in patients treated with upfront surgery. Furthermore, GATA6 is implicated in immunomodulation, although a comprehensive investigation of its immunological role is lacking. Treatment-naive PDAC tumors with varying GATA6 expression yield distinct immunological landscapes. Tumors highly expressing GATA6 show reduced infiltration of immunosuppressive regulatory T cells and M2 macrophages but increased infiltration of immune-stimulating, antigen-presenting, and activated T cells. Our findings caution against solely relying on GATA6 for molecular subtyping in clinical trials and open avenues for exploring immune-based combination therapies.

Efficacy of two brief trauma-focussed writing interventions in comparison to positive experiences writing: A randomized controlled trial.

BACKGROUND: There is emerging literature regarding the efficacy of trauma-focussed writing therapies (TF-WTs) for posttraumatic stress. Such therapies have the potential to reduce posttraumatic stress symptoms (PTSS) in a brief time frame and can be delivered remotely. There remains a need for further research assessing the efficacy of different types of TF-WTs, as well comparing them to alternative control conditions not previously assessed. The present study assessed two TF-WTs that had differing writing instructions in comparison to an intervention that involved writing about positive experiences. METHODS: Adult community participants (n = 83) with subthreshold or clinical PTSD symptoms were randomized to one of three conditions (two of which involved trauma-focussed writing, and the other involved writing about positive experiences). All conditions involved three weekly telehealth-delivered writing appointments. Outcomes were measured using the PTSD Checklist (PCL-5) and the Depression, Anxiety and Stress Scales (DASS-21), and were evaluated at baseline, one-week post-intervention, and five-weeks post-intervention. This trial was registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR Protocol 12620001065987). RESULTS: There was no evidence that the two TF-WTs were more efficacious in reducing PTSS or producing clinically meaningful change in comparison to positive experiences writing. Instead, a significant reduction from baseline to follow-up in PTSS, depression, anxiety and stress was observed in all three conditions. LIMITATIONS: The results should be interpreted with consideration of the modest sample size and absence of longer-term follow-up. CONCLUSIONS: Three-session trauma-focussed writing delivered via telehealth may not be superior to writing about positive experiences.

Treatment of Moderate-to-Severe Pain in Hepatocellular Carcinoma with Transcutaneous Electrical Acupoint Stimulation: A Randomized Controlled Trial.

Objective: Moderate-to-severe pain is the most common clinical symptom in patients with hepatocellular carcinoma (HCC).This trial aimed to analyze the clinical efficacy of Transcutaneous electrical acupoint stimulation (TEAS) in patients of HCC with severe pain and provide a reliable reference for optimizing the clinical diagnostic and therapeutic strategies of HCC. Methods: A total of 104 eligible patients were randomly allocated to experimental and control groups in a ratio of 1:1.The treatment was administered for 1 week continuously. Patients in both groups were followed up 1 week after the end of the treatment.The primary outcome measure was the Numerical Rating Scale (NRS) score, whereas the secondary outcome measures included Brief Pain Inventory BPI-Q3, Q4, Q5 scores, analgesic dose, frequency of opioid-induced gastrointestinal side effects, Karnofsky Performance Status (KPS), Quality of Life Scale - Liver Cancer (QOL-LC), and Brief Fatigue Inventory (BFI) scores. Results: The NRS scores of experimental group was significantly lower after treatment and at the follow-up than baseline (average P<0.01), there were also statistical differences between the groups at the above time points (average P<0.01). BPI-Q3, -Q4, and -Q5 scores in the experimental group were decreased after treatment when compared with those before treatment (average P<0.01). Furthermore, there were significant improvements of gastrointestinal side effects, KPS, QOL-LC and BPI in the experimental group after treatment, and the above results were statistically significant compared to the control group. Conclusion: 7-day TEAS treatment can significantly enhance the analgesic effect and maintain for the following week, also reduce the incidence of gastrointestinal side effects caused by opioids, and improve the quality of life of patients with moderate-to-severe HCC-related pain, which has reliable safety and certain clinical promotion value.

Guided web app intervention for reducing symptoms of depression in postpartum women: Results of a feasibility randomized controlled trial.

Background: Chile faces a significant postpartum depression prevalence and treatment gap, necessitating accessible interventions. While cognitive-behavioral internet-based interventions have proven effective in high-income countries, this field is underdeveloped in Chile. Based on the country's widespread use of digital technology, a guided 8-week cognitive-behavioral web app intervention named "Mamá, te entiendo" was developed. Objective: This study aimed to assess the acceptability and feasibility of "Mamá, te entiendo", for reducing depressive symptomatology in postpartum women. Methods: Sixty-five postpartum women with minor or major depression were randomly assigned to either intervention or waitlist. Primary outcomes centered on study feasibility, intervention feasibility, and acceptability. Semi-structured interviews with a sub-sample enriched the understanding of participants' experiences. Secondary outcomes included mental health variables assessed at baseline, post-intervention, and 1-month follow-up. Results: Chilean women displayed great interest in the intervention. 44.8 % of participants completed the intervention. Participants reported high satisfaction and engagement levels, with interviewees highlighting the value of the intervention's content, exercises, and therapist's feedback. However, preliminary efficacy analysis didn't reveal a significant interaction between group and time for outcome measures. Discussion: This research represents a pioneering effort in Chile to evaluate an internet-based intervention for postpartum depression symptoms. The demonstrated feasibility and acceptability highlight the potential of integrating technology-driven approaches into mental health interventions. However, the intervention did not demonstrate superiority, as both groups exhibited similar positive progress in several outcomes. Therefore, the following research phase should involve a larger and more diverse sample to assess the intervention's effectiveness, identify influencing factors, and determine the individuals who benefit the most.

Posterolateral Fusion Versus Posterior Lumbar Interbody Fusion for Adult Low-Grade Isthmic Spondylolisthesis: Analysis of Sagittal Radiographic Parameters - A Randomized Controlled Trial.

STUDY DESIGN: Randomized controlled trial. OBJECTIVES: To compare the effect of posterolateral fusion (PLF) and posterior lumbar interbody fusion (PLIF) on sagittal radiographic parameters in patients with low-grade isthmic spondylolisthesis. Additionally, to explore the correlation between changes in these parameters and clinical outcomes. METHODS: Forty-six consecutive patients with single-level low-grade isthmic spondylolisthesis were initially enrolled. They were randomly assigned to undergo either PLF or PLIF. Patients were followed up for at least 24 months. Radiographic outcomes included pelvic incidence, pelvic tilt, sacral slope, lumbar lordosis, sagittal vertical axis, T1 pelvic angle, slip angle, slip degree and disc height. Clinical outcomes were assessed by the Oswestry Disability Index (ODI) and visual analogue scale (VAS). RESULTS: Four participants were lost to follow-up. Of the remaining 42 patients, 29 were female. The mean age was 40.23 ± 10.25 years in the PLF group and 35.81 ± 10.58 years in the PLIF group. There was a statistically significant greater correction of all radiographic parameters in the PLIF group. The ODI and VAS improved significantly in both groups, with no significant differences between the two groups. Changes in the ODI and VAS were significantly correlated with changes in disc height, slip angle and lumbar lordosis. CONCLUSIONS: In patients with low-grade isthmic spondylolisthesis, PLIF demonstrates superior efficacy compared to PLF in correcting sagittal radiographic parameters. Nevertheless, this distinction does not seem to influence short-term clinical results. Restoring disc height, correcting the slip angle, and reestablishing normal lumbar lordosis are crucial steps in the surgical management of isthmic spondylolisthesis.

Evaluation of system based psychological first aid training on the mental health proficiency of emergency medical first responders to natural disasters in China: a cluster randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of a system based psychological first aid (PFA) training programme for emergency medical first responders in China. DESIGN: Parallel-group, assessor-blinded, cluster randomised controlled trial. SETTING: 42 clusters of health workers from various health facilities in China. PARTICIPANTS: 1399 health workers who provide emergency service for survivors of disasters. INTERVENTIONS: One-day system based PFA training programme (PFA) or training as usual (TAU). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the PFA skills, knowledge and attitude (SKA-PFA) score at 2 months postintervention. Secondary outcomes included post-traumatic growth, self-efficacy and professional quality of life. RESULTS: The intervention group (n=690) had significantly higher SKA-PFA scores than the control group (n=709) at 2 months postintervention (adjusted mean difference=4.44; 95% CI 1.17 to 7.52; p=0.007; Cohen's d=0.35). The intervention group also had higher scores on post-traumatic growth (p=0.113, d=0.24), self-efficacy (p=0.032, d=0.20) and professional quality of life (p=0.281, d=0.04). CONCLUSIONS: The system based PFA training programme was more effective than the TAU in enhancing the PFA knowledge and skills of the emergency medical first responders and in increasing their competence to provide emergency service for survivors in China. TRIAL REGISTRATION NUMBER: ChiCTR2200060464.

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial).

INTRODUCTION: By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery. METHOD AND ANALYSIS: This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: NCT05464394.

Comparative effect of Tai Chi and aerobic exercise on cognitive function in advanced lung cancer survivors with perceived cognitive impairment: a three-arm randomized controlled trial with mediation analysis.

PURPOSE: Cancer-related cognitive impairment is prevalent in metastatic lung cancer survivors. This study aimed to compare the effectiveness of aerobic exercise and Tai Chi on perceived cognitive function and the mediating role of psychoneurological symptoms with perceived cognitive impairment. METHODS: In a subgroup of a parent randomized clinical trial, participants who reported cognitive impairment underwent a 16-week aerobic exercise (n = 49), Tai Chi (n = 48), and control (n = 54) groups. Measures included perceived cognitive function and psychoneurological symptoms (sleep disturbance, fatigue, anxiety, and depression) assessed at baseline (T0), 16-week (T1), and 1 year (T2). RESULTS: Participants in Tai Chi showed significant improvements compared to aerobic exercise and control groups in perceived cognitive function at T1 (AE: between-group difference, 6.52; P < 0.001; CG: 8.34; P < 0.001) and T2 (AE: between-group difference, 3.55; P = 0.05; CG: 5.94; P < 0.001). Sleep disturbance, fatigue, anxiety, and depression at month 12 explained 24%, 31%, 32%, and 24% of the effect of the intervention on cognitive function at month 12, respectively. Only anxiety at month 4 explained 23% of the intervention effect at month 12. CONCLUSIONS: Tai Chi demonstrated beneficial effects on cognitive function in advanced lung cancer survivors with perceived cognitive impairment. Improvement in cognitive function was mediated by reducing sleep disturbance, fatigue, anxiety, and depression, highlighting the importance of addressing these symptoms in future interventions to improve cognitive function, with anxiety playing a significant role at an earlier stage. IMPLICATIONS FOR CANCER SURVIVORS: Tai Chi is a potentially safe complementary therapeutic option for managing cognitive impairment in this vulnerable population. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04119778; retrospectively registered on 8 October 2019.