The safety and efficacy of stapler method for transection of the pancreatic parenchyma during pancreatoduodenectomy (STRAP-PD trial): study protocol for a randomized control trial.

BACKGROUND: Pancreaticoduodenectomy is a highly difficult and invasive type of gastrointestinal surgery. Prevention of postoperative pancreatic fistula is important, and this may be possible by the stapler method. METHODS: STRAP-PD is a single center randomized controlled trial. We compare a method of transecting the pancreatic parenchyma in pancreaticoduodenectomy using a surgical stapler device with a conventional transecting method using energy devices (e.g., scalpel, ultrasonic coagulator and incision devices). Patients with soft pancreas who are scheduled to undergo pancreaticoduodenectomy are randomized to arm A (conventional method) or arm B (stapler method). We aim to examine the safety and usefulness of dissection by the automatic suture device, with attention to the rate of pancreatic fistula ISGPF grade B or C and to postoperative complications. This is a single-center randomized study, which began in September 2023 at Wakayama Medical University Hospital. DISCUSSION: Pancreatic parenchymal transection is typically performed either by direct incision using a scalpel or by employing energy devices such as ultrasonic coagulating cutting devices during pancreaticoduodenectomy. In a prospective pilot study, we conducted pancreatic parenchymal transection in 20 consecutive normal pancreatic cases during pancreaticoduodenectomy, observing postoperative pancreatic fistula grade B in one case (5%). Traditional methods involving scalpel incision or the use of ultrasonic coagulating cutting devices have been historically favored but perceived as technically challenging, and they have been reliant upon the surgeon's skill. Notably, relatively high incidences of postoperative pancreatic fistula among patients with soft pancreas have also been observed. Our proposed stapler method may therefore be a useful method responsible for reducing the development of pancreatic fistula. This method would be as part of minimally-invasive surgery for pancreaticoduodenectomy. It uses an endoscopic linear stapler to cut the pancreatic parenchyma, so it is likely to be more convenient than conventional methods and can be used universally. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry, UMIN000052089. the Registration Date on 1st September 2023.

The impact of extremely brief meditation and brief mindfulness interventions on assisted reproductive technologies success rates: A randomised controlled trial.

OBJECTIVE: To investigate the effect of extremely brief meditation (EBMI) or brief mindfulness interventions (Brief MI) on pregnancy rate in women undergoing Assisted Reproductive Technology (ART). METHODS: This is a prospective, three-armed, randomized controlled trial with women undergoing ART cycle, age ranging from 18 to 50 years. In the day of embryo transfer, the patients randomized to Brief MI group received a 15-minute audio of mindfulness. They were instructed to practice it daily, starting from the day of embryo transfer to the day of the pregnancy test, leading to a total of 180-210 minutes. Women randomized to EBMI met once a week during the waiting time between the embryo transfer and pregnancy test day in the same virtual room with a meditator instructor for 40 minutes, totalizing two sessions (80 minutes). The pregnancy rate was assessed via a blood test to measure hCG performed 2 weeks after embryo transfer. RESULTS: A total of 68 women aged 37.5 ± 4.3y were included (EBMI, n = 24; Brief MI, n = 22 and CG, n = 22). Pearson's Chi-square test and Student's t-test for independent samples showed no significant differences between intervention and control groups. Both EBMI and Brief MI had no significant effect on pregnancy rate in women undergoing ART. CONCLUSION: This randomized control trial revealed that the extremely brief meditation (EBMI) or self-managed brief mindfulness intervention (Brief MI) had no significant effect on pregnancy rates in infertile women undergoing ART cycles. TRIAL REGISTRATION NUMBER: NCT04058262.

Perturbational complexity index in assessing responsiveness to rTMS treatment in patients with disorders of consciousness: a cross-over randomized controlled trial study.

BACKGROUND: Disorders of Consciousness (DoC) caused by severe brain injuries represent a challenging clinical entity, which is easy to misdiagnosis and lacks effective treatment options. Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive neuroelectric stimulation method that shows promise in improving consciousness for DoC, especially in minimally conscious state (MCS). However, there is little evidence of its effectiveness, especially in RCT studies. METHODS: Twenty MCS patients participated in a double-blind, randomized, crossover, sham-controlled clinical study to evaluate the safety and efficacy of rTMS for MCS. Subjects were randomized into two groups: one group received rTMS-active for 10 consecutive days (n = 10), and the other group received rTMS-sham for 10 consecutive days (n = 10). After a 10-day washout period, the two groups were crossed over and received the opposite treatment. the rTMS protocol consisted of 2,000 pulses per day in the left dorsolateral prefrontal cortex (L-DLPFC), sent at 10 Hz. The stimulation intensity was 90% of the resting motor threshold. Coma Recovery Scale Revised (CRS-R), the main evaluation index, was evaluated before and after each phase in a double-blind manner. Meanwhile RS-EEG and TMS-EEG data were acquired and relative alpha power (RAP), and perturbational complexity index based on state transitions (PCIst) were caculated. RESULTS: One-way ANOVA revealed significantly higher scores in rTMS-active treatment compared to rTMS-sham across various measures, including CRS-R total score, RAP, PCIst (all P < 0.05). Among the 20 MCS patients, 7 (35%) were identified as responders following rTMS treatment. Compared to rTMS-sham, responder scores for CRS-R, RAP, and PCIst (all P < 0.05) were significantly elevated after rTMS-active treatment. Conversely, there was no significant difference observed in non-responders. Furthermore, post-hoc analysis revealed that baseline PCIst was significantly higher in responders than non-responders. Upon a 6-month follow-up, CRS-R scores significantly increased in all 20 patients (P = 0.026). However, the responder group exhibited a more favorable prognosis compared to the non-responder group (P = 0.031). CONCLUSIONS: Applying 10 Hz rTMS to L-DLPFC significantly increased consciousness level in MCS patients. PCIst is a neurophysiological index that has the potential to evaluate and predict therapeutic efficacy. TRIAL REGISTRATION: www. CLINICALTRIALS: gov , identifier: NCT05187000.

"I think we just saw happier residents": nursing home provider reported readiness assessment of the individualized positive psychosocial interaction (IPPI) program.

OBJECTIVES: This study assessed the readiness of The Individualized Positive Psychosocial Interaction (IPPI) program in the nursing home (NH) setting from the perspective of NH providers implementing the IPPI. The evidence-based IPPI program is designed to help remediate distress and improve mood for residents living with dementia. NH staff are trained to engage residents in brief (i.e. 10-min) one-to-one, preference-based activities to alleviate emotional distress and enhance quality of life. METHOD: NH providers (n = 15) who championed the IPPI implementation completed an exit interview based on the nine domains of the Readiness Assessment for Pragmatic Trials (RAPT). Interviews were audio-recorded, transcribed, and coded by RAPT domains, then scored by the research team to reflect an average for each domain. RESULTS: Providers rated the IPPI program's readiness high on the domains of alignment, impact, risk, implementation protocol, evidence, cost, and acceptability. The domains of measurement and feasibility scored lower, likely due to broader contextual issues and require particular attention. CONCLUSION: Results illustrate that the IPPI program successfully aligns with stakeholder priorities, is a safe intervention with minimal risk, and has beneficial outcomes. The IPPI's low cost, design, and alignment with organizational goals also facilitated implementation while measuring outcomes and staffing considerations impacted organizational capacity for implementation.

The effects of ketogenic metabolic therapy on mental health and metabolic outcomes in schizophrenia and bipolar disorder: a randomized controlled clinical trial protocol.

Background: Schizophrenia, schizoaffective disorder, and bipolar affective disorder are debilitating psychiatric conditions characterized by a chronic pattern of emotional, behavioral, and cognitive disturbances. Shared psychopathology includes the pre-eminence of altered affective states, disorders of thoughts, and behavioral control. Additionally, those conditions share epidemiological traits, including significant cardiovascular, metabolic, infectious, and respiratory co-morbidities, resulting in reduced life expectancy of up to 25 years. Nutritional ketosis has been successfully used to treat a range of neurological disorders and preclinical data have convincingly shown potential for its use in animal models of psychotic disorders. More recent data from open clinical trials have pointed toward a dramatic reduction in psychotic, affective, and metabolic symptoms in both schizophrenia and bipolar affective disorder. Objectives: to investigate the effects of nutritional ketosis via a modified ketogenic diet (MKD) over 14 weeks in stable community patients with bipolar disorder, schizoaffective disorder, or schizophrenia. Design: A randomized placebo-controlled clinical trial of 100 non-hospitalized adult participants with a diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia who are capable of consenting and willing to change their diets. Intervention: Dietitian-led and medically supervised ketogenic diet compared to a diet following the Australian Guide to Healthy Eating for 14 weeks. Outcomes: The primary outcomes include psychiatric and cognitive measures, reported as symptom improvement and functional changes in the Positive and Negative Symptoms Scale (PANSS), Young Mania Rating Scale (YMS), Beck Depression Inventory (BDI), WHO Disability Schedule, Affect Lability Scale and the Cambridge Cognitive Battery. The secondary metabolic outcomes include changes in body weight, blood pressure, liver and kidney function tests, lipid profiles, and markers of insulin resistance. Ketone and glucose levels will be used to study the correlation between primary and secondary outcomes. Optional hair cortisol analysis will assess long-term stress and variations in fecal microbiome composition. Autonomic nervous system activity will be measured via wearable devices (OURA ring and EMBRACE wristband) in the form of skin conductance, oximetry, continuous pulse monitoring, respiratory rate, movement tracking, and sleep quality. Based on the encouraging results from established preclinical research, clinical data from other neurodevelopment disorders, and open trials in bipolar disorder and schizophrenia, we predict that the ketogenic metabolic therapy will be well tolerated and result in improved psychiatric and metabolic outcomes as well as global measures of social and community functioning. We additionally predict that a correlation may exist between the level of ketosis achieved and the metabolic, cognitive, and psychiatric outcomes in the intervention group.

Evaluation and Future Challenges in a Self-Guided Web-Based Intervention With and Without Chat Support for Depression and Anxiety Symptoms During the COVID-19 Pandemic: Randomized Controlled Trial.

BACKGROUND: The COVID-19 pandemic has had an impact on mental health worldwide. Low- and middle-income countries were largely affected by it. Mexico was one of the most affected countries. Extended periods of lockdowns, isolation, and social distancing, among other factors, highlighted the need to introduce web-based psychological interventions to the Mexican population. In this context, Mental Health COVID-19 emerged as a self-guided web-based intervention (SGWI) aimed at adults to improve mental health during the COVID-19 pandemic. OBJECTIVE: This study aims to assess the efficacy of 2 modalities of a self-guided intervention (with and without chat support) in reducing depression symptoms, generalized anxiety, community posttraumatic stress, widespread fear, anxiety, sleep quality, physiological and affective coping, and suicide ideation. In addition, it aimed to compare the moderating role of coping strategies, acceptance, and satisfaction in participants' symptom reduction. We hypothesize that the self-guided, chat-supported modality will show higher efficacy than the modality without chat support in achieving clinical change and better performance as a moderator of depression symptoms, generalized anxiety, community posttraumatic stress, widespread fear, anxiety, sleep quality, physiological and affective coping, and suicide ideation, as well as an increase in participants' satisfaction and acceptability. METHODS: A randomized controlled trial was conducted. Data were collected from May 2020 to June 2022. We performed intrasubject measures at 4 evaluation periods: pretest, posttest, and follow-up measurements at 3 and 6 months. Differences between intervention groups were assessed through the Mann-Whitney U test for continuous variables and the chi-square test for categorical variables. Changes due to intervention were analyzed using Wilcoxon W test. Moderated regression analysis was performed to test the hypothesized moderating role of coping strategies, usability, and opinion about treatment on clinical change. RESULTS: A total of 36 participants completed the intervention; of these, 5 (14%) were part of the SGWI group, and 31 (86%) were on the SGWI plus chat support (SGWI+C) group, which included a chat service with therapists. The perceived high complexity of the system for the SGWI group had a moderating effect associated with a lack of efficacy of the intervention regarding depression, but not when controlled for sociodemographic variables. A perception of lower helpfulness of the intervention was associated with poorer outcomes. Coping strategies did not show moderating effects. CONCLUSIONS: Enhancing the utility of web-based interventions for reducing clinical symptoms by incorporating a support chat to boost treatment adherence seemed to improve the perception of the intervention's usefulness. Web-based interventions face several challenges, such as eliminating complexities in platform use and increasing the users' perceived utility of the intervention, among other issues identified in the study. TRIAL REGISTRATION: ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/study/NCT04468893?tab=results. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/23117.

Family Planning and Children's Human Capital: Experimental Evidence From Urban Malawi.

We conduct a randomized controlled trial that provides pregnant and immediate postpartum women with improved access to family planning through counseling, free transportation to a clinic, and financial reimbursement for family planning services over two years. We study the effects of our intervention on child growth and development outcomes among 1,034 children born to participating women directly before the intervention rollout. We find that children born to mothers assigned to the family planning intervention arm were 0.28-0.34 standard deviations taller for their age and 10.7-12.0 percentage points less likely to be stunted within a year of exposure to the intervention. Children born to mothers assigned to the intervention arm also scored 0.17-0.20 standard deviations higher on a caregiver-reported measure of cognitive development after two years of intervention exposure. Although the nonmeasurement of children is a challenge in our study, our estimates are robust to multiple methods of correcting for potential attrition bias. Our results are consistent with models of fertility that link couples' fertility decisions to child health and human capital. Our results also suggest that improved access to family planning might have positive downstream effects on child health beyond contraceptive use and fertility outcomes.

The efficacy and safety of using prophylactic abdominal drainage after laparoscopic cholecystectomy: A randomized control trial.

Background: The use of prophylactic drainage after laparoscopic cholecystectomy has been a routine practice for many years. However, the debate surrounding using it stems from conflicting evidence regarding its potential benefits and risks. Methods: Patients who underwent laparoscopic cholecystectomy from February 1, 2022, to November 30, 2022, at Aleppo University Hospital were enrolled according to our previously registered protocol (NCT05267860). Results: This study included 232 patients (117 in the drainage group [DG], and 115 in the non-drainage group [NDG]). There was no statistical difference in the patients' main characteristics, comorbidities, and laboratory findings. The duration of the surgical operation in NDG (mean = 44.92, SD = 1.85) was shorter than in DG (mean 55.14, SD = 2.14), with (p = 0.039) statistically significant, which indicates that the use of the drainage led to a prolongation of the surgical operation. The total number of complicated cases reached 22 (9.48%) cases (DG = 9 vs. NDG = 13, p = 0.348) as follows: bleeding (n = 1) (DG = 1 vs. NDG = 0; p = 0.320), bile leak with no established bile duct injury (n = 1) (DG = 1 vs. NDG = 0; p = 0.320), wound infection (n = 12) (DG = 4 vs. NDG = 8; p = 0.443), urinary tract infection (n = 3) (DG = 0 vs. NDG = 3; p = 0.079), prolonged shoulder pain (n = 2) (DG = 0 vs. NDG = 2; p = 0.152), and acute pancreatitis (n = 1) (DG = 1 vs. NDG = 0; p = 0.144). Conclusion: Based on the results of our study, the use of prophylactic drainage was safe, but ineffective, as it did not improve the outcomes statistically significantly or worsen them, which is consistent with previous studies highlighting the need for personalized patient care in this setting.

Effect of a four-week oral Phe administration on neural activation and cerebral blood flow in adults with early-treated phenylketonuria.

BACKGROUND: Phenylketonuria (PKU) is a rare inborn error of metabolism characterized by impaired catabolism of the amino acid phenylalanine (Phe) into tyrosine. Cross-sectional studies suggest slight alterations in cognitive performance and neural activation in adults with early-treated PKU. The influence of high Phe levels on brain function in adulthood, however, remains insufficiently studied. Therefore, we aimed to explore the effect of a four-week period of oral Phe administration - simulating a controlled discontinuation of Phe restriction and raising Phe to an off-diet scenario - on working memory-related neural activation and cerebral blood flow (CBF). METHODS: We conducted a randomized, placebo-controlled, double-blind, crossover, non-inferiority trial to assess the effect of a high Phe load on working memory-related neural activation and CBF in early-treated adults with classical PKU. Twenty-seven patients with early-treated classical PKU were included and underwent functional magnetic resonance imaging (fMRI) of the working memory network and arterial spin labeling (ASL) MRI to assess CBF before and after a four-week intervention with Phe and placebo. At each of the four study visits, fMRI working memory task performance (reaction time and accuracy) and plasma Phe, tyrosine, and tryptophan levels were obtained. Additionally, cerebral Phe was determined by 1H-MR spectroscopy. RESULTS: Plasma Phe and cerebral Phe were significantly increased after the Phe intervention. However, no significant effect of Phe compared to placebo was found on neural activation and CBF. Regarding fMRI task performance, a significant impact of the Phe intervention on 1-back reaction time was observed with slower reaction times following the Phe intervention, whereas 3-back reaction time and accuracy did not differ following the Phe intervention compared to the placebo intervention. CONCLUSION: Results from this present trial simulating a four-week discontinuation of the Phe-restricted diet showed that a high Phe load did not uniformly affect neural markers and cognition in a statistically significant manner. These results further contribute to the discussion on safe Phe levels during adulthood and suggest that a four-week discontinuation of Phe-restricted diet does not demonstrate significant changes in brain function.

A phase 3, randomized, double-blind, sham-controlled trial of SI-6603 (condoliase) in patients with radicular leg pain associated with lumbar disc herniation.

BACKGROUND CONTEXT: SI-6603 (condoliase) is a chemonucleolytic agent approved in Japan in 2018 for the treatment of lumbar disc herniation (LDH) associated with radicular leg pain. Condoliase, a mucopolysaccharidase with high substrate specificity for glycosaminoglycans (GAGs), offers a unique mechanism of action through the degradation of GAGs in the nucleus pulposus. As LDH management is currently limited to conservative approaches and surgical intervention, condoliase could offer a less invasive treatment option than surgery for patients with LDH. PURPOSE: The Discover 6603 study (NCT03607838) evaluated the efficacy and safety of a single-dose injection of SI-6603 (condoliase) vs sham for the treatment of radicular leg pain associated with LDH. STUDY DESIGN/SETTING: A randomized, double-blind, sham-controlled, phase 3 study conducted across 41 sites in the United States. PATIENT SAMPLE: Male and female participants (N=352; aged 30-70 years) with contained posterolateral LDH and unilateral radiculopathy/radicular leg pain for greater than 6 weeks. OUTCOME MEASURES: The primary endpoint was the change from baseline (CFB) in average worst leg pain score at 13 weeks, assessed using the 100-mm visual analogue scale. Key secondary endpoints were CFB in average worst leg pain score at 52 weeks, herniation volume at 13 weeks, and Oswestry Disability Index (ODI) score at 13 weeks. Safety evaluations included adverse events (AEs) and imaging findings. METHODS: Participants were randomized 1:1 to receive a single intradiscal injection of condoliase (1.25 units) or sham injection followed by 52 weeks of observation. The primary and key secondary endpoints were assessed using a mixed model for repeated measures (MMRM) analysis and a protocol-specified multiple imputation (MI) sensitivity analysis on the modified intention-to-treat (mITT) population. A prespecified serial gatekeeping algorithm was used for multiple comparisons. Safety endpoints included AEs, laboratory tests, vital signs, imaging (by X-ray and magnetic resonance imaging [MRI]), and occurrence of posttreatment lumbar surgery. RESULTS: Of the 352 randomized participants, 341 constituted the mITT population (condoliase n=169; sham n=172) and the safety population (condoliase n=167; sham n=174). For the primary endpoint, the condoliase group showed significantly greater improvement in CFB in worst leg pain at Week 13 (least squares mean [LSM] CFB: -41.7) compared with sham injection (-34.2; LSM difference: -7.5; 95% confidence interval [CI]: -14.1, -0.9; p=.0263) based on the MMRM analysis. CFB in worst leg pain at Week 52 favored condoliase vs sham, but the difference was not statistically significant (p=.0558), which halted the serial gatekeeping testing algorithm and dictated that the CFB in herniation volume and ODI scores at Week 13 would be considered nonsignificant, regardless of their p-values. Treatment group differences in CFB in herniation volume and ODI score favored the condoliase group vs sham at all timepoints. The MI sensitivity analysis showed differences in CFB in worst leg pain at Week 13 (p=.0223) and Week 52 (p=.0433) in favor of the condoliase group. Treatment-emergent AEs (TEAEs) were more common in the condoliase group (≥1 TEAE: 71.9%; ≥1 treatment-related TEAE: 28.1%) compared with the sham group (≥1 TEAE: 60.3%; ≥1 treatment-related TEAE: 10.3%). Of the TEAEs, spinal MRI abnormalities and back pain occurred most frequently. No treatment-related serious AEs occurred. CONCLUSIONS: Condoliase met its primary endpoint of significantly improving radicular leg pain at Week 13 and was generally well tolerated in patients with LDH. Chemonucleolysis with condoliase has the potential to provide a less invasive treatment option than surgery for those unresponsive to conservative treatment strategies.

Robotic arthroplasty software training improves understanding of total knee arthroplasty alignment and balancing principles: a randomized controlled trial.

Understanding alignment and gap balancing in Total Knee Arthroplasty (TKA) can be challenging for trainee and experienced orthopedic surgeons. Traditional learning methods may not effectively translate to real-life scenarios. The advent of advanced technologies like robotic surgery and navigation systems has revolutionized intraoperative understanding of gap balancing techniques. This trial aims to investigate the effectiveness of robotic TKA planning software in educating trainees about alignment and ligament balancing. We hypothesize that a single session with the software will significantly enhance trainees' understanding of these techniques. This UK-based single-center, two-arm, group parallel randomized controlled trial was conducted during a national robotic arthroplasty symposium. It aims to evaluate the effect of robotic knee arthroplasty software training on understanding TKA alignment and gap balancing principles using Multiple Choice Questions (MCQs). The MCQ test was crafted based on established guidelines from a different institution with expert consensus in the field. Our study revealed that baseline knowledge of gap balancing and alignment principles was generally low among all participants. However, the intervention group, which received comprehensive robotic software training, demonstrated a significant improvement in their MCQ scores compared to the control group, which did not undergo the training. In conclusion, our study demonstrates that robotic arthroplasty software training significantly improves the understanding of TKA alignment and balancing principles among orthopedic trainees. Level of Evidence II.

Practice-based research in dentistry: Exploring methodologies, benefits, and challenges.

BACKGROUND: Practice-Based Research Network (PBRN) studies typically assess the effectiveness of clinical interventions in settings that match real-world conditions. Dental PBRNs have the capacity to amass, identify, and analyze vast amounts of data from patient populations that include diverse racial, ethnic, socio-economic, and geographic backgrounds. These dental studies encompass a broad spectrum of healthcare aspects, including prevention, diagnosis, symptom and disease treatment, quality enhancement, and care coordination. METHODS: An extensive range of research methodologies can be employed within dental PBRNs to investigate these topics, including randomized controlled trials. Dental PBRNs have evolved from primarily focusing on case observations to leveraging advanced network infrastructure and collaborating across multiple regional and national sites. In addition to producing numerous high-impact peer-reviewed publications, study results have led to improved clinical care. However, PBRNs encounter challenges, such as the sustainability of research capacity (relying heavily on ongoing support from funding agencies), diverse research cultures, and an imperative to design studies that are both feasible and relevant to everyday clinical practice. Recognizing the pivotal role of real-world evidence, it is important to have sustained investment in dental PBRN infrastructure and feasible opportunities for practitioners to participate in network activities nationwide. CONCLUSION: Practice-Based Research Network studies capitalize on an important research context within which to investigate a range of clinical topics that can employ multiple research methodologies. However, sustaining productive networks requires strategic effort, ongoing financial support, and customized organizational skills.

Remote monitoring of automated peritoneal dialysis reduces mortality, adverse events, and hospitalizations: a cluster randomized controlled trial.

BACKGROUND AND HYPOTHESIS: Remote monitoring (RM) of patients on automated peritoneal dialysis (APD) prevent complications and improve treatment quality. We analyzed the effect of RM-APD on mortality and complications related to cardiovascular disease (VD), fluid overload and insufficient dialysis efficiency. METHODS: In a cluster-randomized, open-label, controlled trial, 21 hospitals with APD programs were assigned to use either RM-APD (10 hospitals; 403 patients) or conventional APD (11 hospitals; 398 patients) for the treatment of adult patients starting PD. Primary outcomes were time to first event of: 1) Composite Index-1 comprising all-cause mortality, first adverse events and hospitalizations of any cause, and 2) Composite Index-2 comprising cardiovascular mortality, first adverse event and hospitalizations related to CVD, fluid overload and insufficient dialysis efficiency. Secondary outcomes were time to first event of individual components of the two composite indices, and rates of adverse events, hospitalizations, unplanned visits, and transfer to hemodialysis. Patients were followed for a median of 9.5 months. Primary outcomes were evaluated by competing-risk analysis and restricted mean survival time (RMST) analysis. RESULTS: While time to reach Composite Index-1 did not differ between the groups, Composite Index-2 was reached earlier (ΔRMST: -0.85 months; p=0.02), and all-cause mortality (55 vs. 33 deaths, p=0.01; sHR 1.69 (95%CI 1.39-2.05), p<0.001) and hospitalizations of any cause were higher in APD group than in RM-APD as were cardiovascular deaths (24 vs. 13 deaths, p=0.05; sHR 2.44 (95%CI 1.72 - 3.45), p<0.001) and rates of adverse events and hospitalizations related to CVD, fluid overload or insufficient dialysis efficiency. Dropouts were more common in the APD group (131 vs. 110, p=0.048). CONCLUSIONS: This randomized controlled trial shows that remote monitoring may add significant advantages to APD, including improved survival and reduced rate of adverse events and hospitalizations, which can favorably impact the acceptance and adoption of the therapy.

Empowering the helping hands: A positive psychological intervention for enhancing work engagement and reducing stress among preschool social workers in Hong Kong.

This study explores the efficacy of the Early Advancement in Social-Emotional Health and Positivity (EASP) programme, designed to enhance personal resources, namely self-compassion and positivity among preschool social workers, to reduce stress and bolster work engagement. A total of 84 preschool social workers (Mage = 32.47 years, SD = 6.86, range = 22-55; female = 90.48%) participated in a 5-week randomized control trial. Participants were randomly allocated to either the intervention group (n = 38), which received four online workshops and an online activity, or the wait-list control group (n = 46), which received the intervention post-data collection. Self-compassion, positivity, work engagement, and work stress were measured before and after the intervention. Results from a path analytic model indicated excellent fit with the data, χ2 = 2.08, df = 3, Comparative Fit Index = 1.00, Tucker-Lewis Index = 1.00, Root Mean Square Error of Approximation = 0.00 (90% CI = 0.00-0.16), SRMR = 0.03. The intervention demonstrated direct effects on changes in self-compassion (ß = 0.21, p = 0.04) and positivity (ß = 0.28, p = 0.03), with indirect effects on work engagement (ß = 0.13, p = 0.02), while no significant impact was observed on work stress (ß = -0.09, p = 0.06). These findings underscore the efficacy of positive psychological interventions in fostering work engagement among social workers. Incorporating the EASP programme into ongoing professional development activities is recommended to enhance the job engagement and psychological well-being of social workers in early childhood education and care sectors.

Effect of WhatsApp-based BETTER model sexual counselling on sexual function and sexual quality of life in breast cancer survivors: a randomized control trial.

OBJECTIVE: The aim of the study was to determine the effect of WhatsApp-based BETTER sex counselling on sexual function and sexual quality of life in breast cancer survivors in a randomized control trial. METHODS: This is a randomized controlled trial in which a total of 90 breast cancer survivors were recruited using convenience sampling and then randomly assigned to two groups of WhatsApp-based BETTER model counselling and routine care. Data collection tools consisted of a demographic questionnaire, the Sexual Quality of Life-Female (SQOL-F) and the Sexual Function Index (FSFI-BC). Participants in the intervention group were given access to the 6-week program. The program consisted of six consultation and assignment packages covering all six steps of the BETTER model. Data were analyzed using SPSS software version 20. Chi-square test, independent samples t-test and repeated measures analysis of variance were used. The significance level (p-value) was considered to be less than 0.05. RESULTS: In the control group, the mean score of SQL scale changed from 35.16 ± 10.71 to 35.16 ± 12.97 (P > 0.05) and in the intervention group, it significantly increased from 34.76 ± 10.13 to 68.20 ± 20.48 (P < 0.001). Similarly, the comparison of mean of FSF in the control group showed a none-significant change from 58.13 ± 7.11 to 58.35 ± 6.11 (P > 0.05), and in the intervention group, it significantly improved from 59.49 ± 6.10 to 120.73 ± 25.54 (P < 0.001). The results of rANOVA indicated that there was a significant difference in the mean scores of the SQL and SFS between the two groups from pre- to post-intervention, and then over the 1-month follow-up period in the intervention group (p < 0.001). Considering partial eta squared, the effect of the intervention had the highest interaction effect on both variables of the sexual function index (η2 = 0.73) and sexual quality of life (η2 = 0.41). CONCLUSIONS: The intervention program was a successful model for improving female sexual quality of life and female sexual function in breast cancer survivors. TRIAL REGISTRATION: IRCT20210926052601N1, 7-11-2021.

Randomized Controlled Trial of Remimazolam Compared with Placebo in Japanese Patients Undergoing Colonoscopy: A Phase III, Investigator-Initiated Trial.

INTRODUCTION: We conducted an investigator-initiated clinical trial in which remimazolam was used to achieve sedation in patients undergoing colonoscopies. METHODS: This multicenter, double-blind, placebo-controlled, phase III investigator-initiated trial included patients who underwent colonoscopy under sedation with remimazolam (initial dose: 3 mg; additional dose: 1 mg) or normal saline (placebo). The primary endpoint of the study was the successful sedation rate during colonoscopy, defined as achieving a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of ≤4 before the procedure, maintaining this score throughout colonoscopy, and requiring no more than five additional drug doses per 15 min. RESULTS: The sedation success rate was 95.0% (38/40 patients) in the remimazolam group and 0.0% (0/11 patients) in the placebo group (p < 0.01). The time from the end of procedure to regaining consciousness was 0.0 (interquartile range: 0.0-0.0) min in both groups. The time from the end of the procedure to ambulation was 5.0 (interquartile range: 0.0-10.0) min in the remimazolam group and 0.0 (interquartile range: 0.0-0.0) min in the placebo group (p = 0.02). Serious adverse events were not observed. CONCLUSION: The use of remimazolam to achieve sedation in Japanese patients undergoing colonoscopy was more effective than placebo.

Financial incentives for sanitation take-up: A randomized control trial in rural Vietnam.

This study assesses the impact of financial incentives on hygienic latrine ownership by poor/near-poor households in Vietnam. Rural communes were randomly assigned to a control group and three treatment arm groups: (T1) a rebate for households that installed a hygienic latrine; (T2) a financial reward for commune governments if the proportion of hygienic latrines in their commune increased by 30 percentage points; (T3) both a household rebate and a commune reward. We find a strong and positive effect from the household rebate (treatment arms 1 and 3) but an insignificant effect from the commune reward (treatment arm 2) on household ownership of a septic tank latrine. Our analysis provides suggestive evidence that microcredit is a channel through which a rebate encourages the installation of septic tank latrines. We also find that treatment arm 3 increases people's knowledge regarding sanitation and the availability of water and soap for handwashing within households.

Scoping Review of Acceptance and Commitment Therapy for Obsessive-Compulsive Disorder in Iran.

Acceptance and commitment therapy (ACT) for obsessive-compulsive disorder (OCD) has been found efficacious in randomized clinical trials (RCTs), but the two widely known RCTs were conducted within the United States with predominantly White samples. Research that evaluates treatments like ACT for OCD outside the typical Western cultures is needed. The current scoping review summarizes the key characteristics and findings from 18 RCTs that evaluated ACT for OCD in Iran. These RCTs are largely unknown in the broader scientific literature despite representing the vast majority of ACT for OCD trials, in part because the majority are published in Persian. The preponderance of RCTs treated participants in groups, and most protocols did not include exposure exercises. Of 18 trials, 5 were single sex. Use of selective serotonin reuptake inhibitors (SSRIs) was common with all participants on stable doses at pretreatment in many of the trials. Methodological quality was low to medium. ACT was inconsistent against nontraditional comparison conditions, slightly favorable to empirically validated treatments, and favorable compared with the waitlist and SSRIs. The process of change data indicated that ACT increased the psychological flexibility more than cognitive behavior therapy or SSRIs. These results highlight that findings on ACT for OCD from Western populations replicate and generalize to individuals in Iran. These findings also offer insights gained from studying ACT in Iran and significantly expand the literature based on ACT for OCD that can be integrated into scholarship by all researchers.

Successful and sustained implementation of a behaviour-change informed strategy for emergency nurses: a multicentre implementation evaluation.

BACKGROUND: Implementing evidence that changes practice in emergency departments (EDs) is notoriously difficult due to well-established barriers including high levels of uncertainty arising from undifferentiated nature of ED patients, resource shortages, workload unpredictability, high staff turnover, and a constantly changing environment. We developed and implemented a behaviour-change informed strategy to mitigate these barriers for a clinical trial to implement the evidence-based emergency nursing framework HIRAID® (History including Infection risk, Red flags, Assessment, Interventions, Diagnostics, communication, and reassessment) to reduce clinical variation, and increase safety and quality of emergency nursing care. AIM: To evaluate the behaviour-change-informed HIRAID® implementation strategy on reach, effectiveness, adoption, quality (dose, fidelity) and maintenance (sustainability). METHODS: An effectiveness-implementation hybrid design including a step-wedge cluster randomised control trial (SW-cRCT) was used to implement HIRAID® with 1300 + emergency nurses across 29 Australian rural, regional, and metropolitan EDs. Evaluation of our behaviour-change informed strategy was informed by the RE-AIM Scoring Instrument and measured using data from (i) a post HIRAID® implementation emergency nurse survey, (ii) HIRAID® Instructor surveys, and (iii) twelve-week and 6-month documentation audits. Quantitative data were analysed using descriptive statistics to determine the level of each component of RE-AIM achieved. Qualitative data were analysed using content analysis and used to understand the 'how' and 'why' of quantitative results. RESULTS: HIRAID® was implemented in all 29 EDs, with 145 nurses undertaking instructor training and 1123 (82%) completing all four components of provider training at 12 weeks post-implementation. Modifications to the behaviour-change informed strategy were minimal. The strategy was largely used as intended with 100% dose and very high fidelity. We achieved extremely high individual sustainability (95% use of HIRAID® documentation templates) at 6 months and 100% setting sustainability at 3 years. CONCLUSION: The behaviour-change informed strategy for the emergency nursing framework HIRAID® in rural, regional, and metropolitan Australia was highly successful with extremely high reach and adoption, dose, fidelity, individual and setting sustainability across substantially variable clinical contexts. TRIAL REGISTRATION: ANZCTR, ACTRN12621001456842 . Registered 25 October 2021.

Examining external control arms in oncology: A scoping review of applications to date.

OBJECTIVES: Randomized controlled trials (RCTs) are the gold standard for evaluating the comparative efficacy and safety of new cancer therapies. However, enrolling patients in control arms of clinical trials can be challenging for rare cancers, particularly in the context of precision oncology and targeted therapies. External Control Arms (ECAs) are a potential solution to address these challenges in clinical research design. We conducted a scoping review to explore the use of ECAs in oncology. METHODS: We systematically searched four databases, namely MEDLINE, EMBASE, Web of Science, and Scopus. We screened titles, abstracts, and full texts for eligible articles focusing on patients undergoing therapy for cancer, employing ECAs, and reporting clinical outcomes. RESULTS: Of the 629 articles screened, 23 were included in this review. The earliest included studies were published in 1996, while most studies were published in the past 5 years. 44% (10/23) of ECAs were employed in blood-related cancer studies. Geographically, 30% (7/23) of studies were conducted in the United States, 22% (5/23) in Japan, and 9% (2/23) in South Korea. The primary data sources used to construct the ECAs involved pooled data from previous trials (35%, 8/23), administrative health databases (17%, 4/23) and electronic medical records (17%, 4/23). While 52% (12/23) of the studies employed methods to align treatment and ECAs characteristics, 48% (11/23) lacked explicit strategies. CONCLUSION: ECAs offer a valuable approach in oncology research, particularly when alternative designs are not feasible. However, careful methodological planning and detailed reporting are essential for meaningful and reliable results.