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Background: Vitiligo remains a challenging condition to treat. Fire needle therapy, a traditional Chinese medicine technique, has potential as an alternative therapeutic strategy. However, rigorous evidence on its efficacy is lacking. Objective: We aimed to evaluate the efficacy and safety of fire needle therapy, alone and combined with topical tacrolimus ointment, for non‐segmental stable vitiligo. Methods: In this 6‐month randomized self‐controlled trial, 35 vitiligo patients were enrolled, providing three similar lesions each. Lesions were randomly allocated to receive fire needle monotherapy, 0.1% tacrolimus ointment monotherapy, or combined fire needle and tacrolimus ointment therapy. The main outcome was change in vitiligo surface area. Results: In total, 29 patients completed the 6‐month follow‐up. The combination therapy group showed significantly greater reductions in vitiligo surface area compared to monotherapy groups starting at months 4 and 5. By the end of the study, combination therapy resulted in remarkably higher repigmentation responses, with 89.7% of lesions showing at least mild (≥25%) repigmentation and 51.7% showing good (≥50%) repigmentation. This significantly exceeded the outcomes with topical tacrolimus ointment alone, which only achieved 6.9% mild response and 6.9% good response. Fire needle monotherapy also demonstrated steady repigmentation over time, with 69% of lesions attaining a mild response by month 6. Importantly, no major adverse events occurred. Conclusion: This study provides promising preliminary evidence supporting the use of fire needle therapy, alone or in combination with topical tacrolimus ointment, for inducing repigmentation in non‐segmental stable vitiligo. As a non‐pharmacological approach, fire needle therapy warrants further study as an alternative vitiligo treatment. [ABSTRACT FROM AUTHOR]

Introduction: Neck pain constitutes a prevalent and burdensome health issue, substantially impairing patients' quality of life and functional capabilities. Kinesio taping (KT), a commonly employed intervention within physical therapy, holds promise for mitigating such symptoms; however, a comprehensive evaluation of its efficacy and evidence base is lacking. Therefore, this study endeavors to systematically investigate the therapeutic effects of KT on both subjective neck pain intensity and objective measures of physical activity limitations through a rigorous meta-analytic approach. By synthesizing existing literature and scrutinizing methodological nuances, we aim to furnish healthcare practitioners with evidence-informed insights, facilitating more judicious clinical decision-making and optimizing patient outcomes. Methods: According to the PRISMA guidelines, we conducted searches on PubMed, Cochrane Library, Embase, and Web of Science for randomized controlled trials (RCTs) investigating the efficacy of KT in treating neck pain. Screening was performed based on predefined inclusion and exclusion criteria. Characteristics of the included RCTs were extracted. Trial heterogeneity was assessed using the I2 statistic. Meta-analysis was conducted using Stata 17 software. Risk of bias and methodological quality were evaluated using the Cochrane Risk of Bias 2 tool and the PEDro scale, respectively. Results: In our analysis of 10 RCTs involving 620 patients meeting our inclusion criteria, KT demonstrated significant beneficial effects on neck pain, notably surpassing conventional treatment (weighted mean difference = −0.897, 95% CI −1.30 to −0.49, P < 0.001). Subgroup analysis further revealed that KT exhibited particularly pronounced efficacy in the treatment of nonspecific neck pain and mechanical neck pain, with a more substantial effect observed after 4 weeks of KT intervention compared to 1 week. Moreover, KT demonstrated superior efficacy in alleviating pain symptoms compared to both conventional treatment and sham interventions. Conclusion: KT has demonstrated efficacy in reducing neck pain and improving cervical dysfunction among patients. Prolonged KT treatment or its combination with other therapeutic modalities may potentially enhance therapeutic outcomes. Systematic Review Registration: PROSPERO CRD42024524685. [ABSTRACT FROM AUTHOR]

Background: Maintenance of physical function, mobility, and independent living are important goals for older adults. However, concerns about falling (CaF) play a central role in the vicious cycle of CaF, inflammation, loss of muscle mass, and decreasing physical function ultimately resulting in negative health outcomes. CaF, like other states of chronic stress and anxiety, can be considered as enduring adverse stimuli affecting the stress systems and the inflammatory system. Therefore, the aim of this study is to investigate whether a reduction of CaF leads to a reduction of stress and therefore possibly reduces chronic low-grade inflammation. Understanding the role and directionality of the effects of inflammation on CaF increases our understanding of age-related loss of mobility and physical function. Methods: In this study, community-dwelling older adults, aged 70 years and older, will be randomly assigned to either a 4-month, multi-component intervention with exercise training and cognitive-behavioral components or to a sham control group with light stretching exercises, cognitive training, and educational health lectures. For the operationalization of specific CaF, the Falls Efficacy Scale—International will be used. Stress and related psychological symptoms will be monitored using established self-reports and by measuring salivary cortisol. Concentrations of C-reactive protein, interleukin 6, interleukin 10, and tumor-necrosis-factor-alpha, as well as gene expression of selected inflammatory transcripts, will be used as surrogate parameters of the inflammatory status at baseline, after the 4-month intervention and 8-month follow-up. Discussion: This study will be the first to test whether CaF are related with stress system activity or reactivity or with markers of inflammation in the context of a multi-component intervention with exercise training and cognitive-behavioral components addressing CaF. The reduction of specific CaF or general psychological symptoms should reverse alterations in stress systems, and / or slow down low-grade inflammation. Changes in activity, as well as psychological and biological pathways leading from CaF to muscle loss will be measured, to disentangle the individual contribution to sarcopenia, and to provide an additional pathway to break or slow-down the vicious cycle of CaF and sarcopenia. Trial registration: German Clinical Trials Register (DRKS): DRKS00029171. Registered 22 July 2022. [ABSTRACT FROM AUTHOR]

Background: The rate of vitamin D deficiency (VDD) in critically ill children worldwide has been estimated at 50%. These children are at risk of multiple organ dysfunction, chronic morbidity, and decreased health related quality of life (HRQL). Pediatric and adult ICU clinical trials suggest that VDD is associated with worse clinical outcomes, although data from supplementation trials are limited and inconclusive. Our group's phase II multicenter dose evaluation pilot study established the efficacy and safety of an enteral weight-based cholecalciferol loading dose to rapidly restore vitamin D levels in critically ill children. Methods: Our aim is to evaluate the impact of this dosing regimen on clinical outcomes. VITdALIZE-KIDS is a pragmatic, phase III, multicenter, double-blind RCT aiming to randomize 766 critically ill children from Canadian PICUs. Participants are randomized using a 1:1 scheme to receive a single dose at enrollment of enteral cholecalciferol (10,000 IU/kg, max 400,000 IU) or placebo. Eligibility criteria include critically ill children aged newborn (> 37 weeks corrected gestational age) to < 18 years who have blood total 25-hydroxyvitamin D < 50 nmol/L. The primary objective is to determine if rapid normalization of vitamin D status improves HRQL at 28 days following enrollment. The secondary objective is to evaluate the impact of rapid normalization of vitamin D status on multiple organ dysfunction. The study includes additional tertiary outcomes including functional status, HRQL and mortality at hospital discharge and 90 days, PICU and hospital length of stay, and adverse events related to vitamin D toxicity. Additionally, we are performing comprehensive vitamin D speciation and non-targeted metabolite profiling as part of a sub-study for the first 100 participants from whom an enrollment and at least one post-intervention blood and urine sample were obtained. Discussion: The VITdALIZE-KIDS trial is the first phase III, multicenter trial to evaluate whether rapid normalization of vitamin D status could represent a simple, inexpensive, and safe means of improving outcomes following pediatric critical illness. Recruitment was initiated in June 2019 and is expected to continue to March 2026. Trial registration: Clinicaltrials.gov, NCT03742505. Study first submitted on November 12, 2018 https://clinicaltrials.gov/study/NCT03742505 [ABSTRACT FROM AUTHOR]

Background: Rotator cuff calcific tendinitis (RCCT) is a common shoulder disease whose main symptoms include shoulder pain, limited mobility, and calcification deposits in the shoulder. Traditional treatment methods have certain limitations, so finding new treatment methods has become the focus of research. Extracorporeal shock wave (ESW) and platelet-rich plasma (PRP) treatments have attracted much attention due to their non-invasive and tissue repair-promoting properties; however, the efficacy of their combined treatment in RCCT remains unclear. Methods: This study is designed as a single-center, assessment-blind, randomized controlled clinical trial with three parallel groups. Sixty subjects will be recruited and randomly divided into the ESW group, PRP group, and ESW combined with PRP group, in a 1:1:1 ratio. The entire intervention period is 4 weeks, and the follow-up period is 4 weeks. Outcomes will be measured at baseline (T0), after 1 week of intervention (T1), after 2 weeks of intervention (T2), after 4 weeks of intervention (T3), and after an additional 4 weeks of follow-up period (T4). The primary endpoint is the VAS score. Secondary endpoints are ASES, CMS, UCLA, and the location and size of calcified areas. Discussion: This study aims to evaluate the efficacy of ESW therapy combined with PRP in treating RCCT. We compare the effects of single and combined treatments to explore their impact on disease symptoms, functional improvement, and calcification regression. This provides a scientific basis for identifying more effective treatment options. Trial registration: ClinicalTrials.gov NCT06372600. Registered on April 17, 2024; version 1. [ABSTRACT FROM AUTHOR]

Background: Multiple Sclerosis (MS) is a chronic inflammatory neurodegenerative disease with diverse symptomatology, significantly impacting patients' quality of life (QoL). While pharmacological therapies focus primarily on reducing inflammation and relapse rates, non-pharmacological interventions, including digital health applications, have shown promise in improving QoL among persons with MS (PwMS). Pilot studies had shown the feasibility and acceptability of levidex, a digital health application based on cognitive behavioral therapy (CBT) principles, a broad set of behavior change techniques, and relevant lifestyle-change advice. This randomized controlled trial aimed to examine the effects of levidex on MS-related QoL over 6 months. Methods: Participants who were diagnosed with MS for at least one year were recruited via the internet in Germany, using a secure survey software platform, and were randomly assigned to the intervention group (IG), in which they received standard care + levidex, or an active control group (CG), in which they received standard care and were offered web-adapted material on the topic of lifestyle change from the German Multiple Sclerosis Society (DMSG). The primary outcome was MS-related QoL after 6 months, measured by the Hamburg Quality of Life Questionnaire in MS (HAQUAMS); secondary outcomes included QoL subscales, sick days, and health behavior, among others. Analyses of Covariance (ANCOVA) were used to examine intervention effects at 6 months. Participants were recruited between November 2020 and February 2022. Results: A total of 421 adult participants (mean age: 47.5, 78.1% women) were included and randomized (IG, n = 195, CG, n = 226). After 6 months, the IG exhibited significantly higher MS-related QoL, compared to the CG (total score HAQUAMS, adjusted group mean difference = -0.14, 95% CI: [-0.22, -0.06], p = 0.001; Cohen's d = 0.23), with significant effects also observed on the cognitive and mood subscales. At 6 months, IG participants also reported significantly fewer sick days (median = 2 days in IG vs. 6 days in CG; W = 3939, p = 0.012) and significantly higher levels of daily activities, as measured by the Frenchay Activity Index, adjusted group mean difference = 1.37, 95% CI = [0.33, 2.40], p = 0.010; Cohen's d = 0.16. Safety analyses showed no adverse events and good satisfaction. Conclusions: Compared to the control group, levidex facilitated clinically relevant improvements in MS-related QoL, reduced sick days, and enhanced activity in PwMS over 6 months. These findings suggest that levidex can serve as an effective non-pharmacological adjunctive treatment element to standard care and could help improve QoL among PwMS. Trial registration: Registered on 22.09.2020 at the German Clinical Trials Register DRKS00023023. [ABSTRACT FROM AUTHOR]

Background: Liver cancer (LC) screening, such as AFP test and abdominal ultrasound, is an effective way to prevent LC, one of the most common cancers worldwide. Despite the proven screening benefits, screening participation among high-risk populations for LC remains low. This suggests that targeted, systematic, and effective interventions should be provided to improve knowledge and awareness related to LC screening, enhance screening intentions, and thereby promote screening behaviors. Telephone is people's main medium of daily communication and mHealth-based programs offer a potential and effective solution for promoting health behaviors. The purpose of this study is to develop and implement a mHealth (WeChat app) based intervention guided by Fogg's Behavior Model (FBM) to augment the knowledge of LC prevention among people at risk of LC and enhance their motivation for screening, and to validate its effectiveness in improving LC screening. Methods: We propose a two-arm, single-blind randomized controlled trial with 82 at-risk individuals of LC, delivering a 6-month mHealth-based intervention program with optional health counseling. Recruitment will be through tertiary hospitals and community organizations in 4 districts in Heng Yang. In total, 82 individuals at high risk for HCC will be randomized 1:1 to intervention or control (usual care) groups. The intervention group will receive intervention, whose contents are based on the FBM model, via multiple forms of media including PowerPoint presentation, multimedia video, health information booklet and screening message, which is delivered in the WeChat Applet. Control dyads will be provided with usual health education. Outcomes will be assessed at baseline and post-intervention. Discussion: The findings of this study will provide evidence of the benefits of utilizing mHealth-based approaches in intervention development to enhance the effectiveness of screening adherence for high-risk people of LC. Further, the findings would provide reference to the potential incorporation of the targeted intervention in local community organizations. Trial registration: Chinese Clinical Trial Registry (ChiCTR2400080530) Date registered: 31/1/2024. [ABSTRACT FROM AUTHOR]

Background: In locally advanced rectal cancer (LARC), optimizing neoadjuvant strategies, including the addition of concurrent chemotherapy and dose escalation of radiotherapy, is essential to improve tumor regression and subsequent implementation of anal preservation strategies. Currently, dose escalation studies in rectal cancer have focused on the primary lesions. However, a common source of recurrence in LARC is the metastasis of cancer cells to the proximal lymph nodes. In our trial, we implement simultaneous integrated boost (SIB) to both primary lesions and positive lymph nodes in the experimental group based on magnetic resonance-guided adaptive radiotherapy (MRgART), which allows for more precise (and consequently intense) targeting while sparing neighboring healthy tissue. The objective of this study is to evaluate the efficacy and safety of MRgART dose escalation to both primary lesions and positive lymph nodes, in comparison with the conventional radiotherapy of long-course concurrent chemoradiotherapy (LCCRT) group, in the neoadjuvant treatment of LARC. Methods: This is a multi-center, randomized, controlled phase III trial (NCT06246344). 128 patients with LARC (cT3-4/N+) will be enrolled. During LCCRT, patients will be randomized to receive either MRgART with SIB (60–65 Gy in 25–28 fractions to primary lesions and positive lymph nodes; 50–50.4 Gy in 25–28 fractions to the pelvis) or intensity-modulated radiotherapy (50–50.4 Gy in 25–28 fractions). Both groups will receive concurrent chemotherapy with capecitabine and consolidation chemotherapy of either two cycles of CAPEOX or three cycles of FOLFOX between radiotherapy and surgery. The primary endpoints are pathological complete response (pCR) rate and surgical difficulty, while the secondary endpoints are clinical complete response (cCR) rate, 3-year and 5-year disease-free survival (DFS) and overall survival (OS) rates, acute and late toxicity and quality of life. Discussion: Since dose escalation of both primary lesions and positive nodes in LARC is rare, we propose conducting a phase III trial to evaluate the efficacy and safety of SIB for both primary lesions and positive nodes in LARC based on MRgART. Trial registration: The study was registered at ClinicalTrials.gov with the Identifier: NCT06246344 (Registered 7th Feb 2024). [ABSTRACT FROM AUTHOR]

Background: Individuals with high blood pressure in India often miss essential follow-up visits. Missed visits contribute to gaps across the hypertension care continuum and preventable cardiovascular disease. Widespread misconceptions around hypertension care and treatment may contribute to low follow-up attendance rates, but to date, there is limited evidence of the effect of interventions to debunk such misconceptions on health-seeking behavior. We conducted a randomized controlled trial to measure whether combining information debunking commonly-held misconceptions with a standard reminder reduces missed follow-up visits among individuals with high blood pressure and investigated whether any observed effect was moderated through belief change. Methods: We recruited 388 patients with uncontrolled blood pressure from the outpatient wards of two public sub-district hospitals in Punjab, India. Participants randomly assigned to the intervention arm received two WhatsApp messages, sent 3 and 1 days before their physician-requested follow-up visit. The WhatsApp message began with a standard reminder, reminding participants of their upcoming follow-up visit and its purpose. Following the standard reminder, we included brief debunking statements aimed at acknowledging and correcting common misconceptions and misbeliefs about hypertension care seeking and treatment. Participants in the control group received usual care and did not receive any messages. Results: We did not find evidence that the enhanced WhatsApp reminders improved follow-up visit attendance (Main effect: 2.2 percentage points, p-value = 0.603), which remained low across both treatment (21.8%, 95% CI: 15.7%, 27.9%) and control groups (19.6%, 95% CI: 14.2%, 25.0%). Participants had widespread misconceptions about hypertension care but our debunking messages did not successfully correct these beliefs (p-value = 0.187). Conclusions: This study re-affirms the challenge of continuity of care for chronic diseases in India and suggests that simple phone-based health communication methods may not suffice for changing prevalent misconceptions and improving health-seeking behavior. Trial registration: The trial began on July 18th. We registered the trial on July 18th (before recruitment began), including the main outcomes, on the German Clinical Trial Register [Identifier: DRKS00029712] and published a pre-analysis plan in the Open Science Framework [osf.io/67g35]. [ABSTRACT FROM AUTHOR]

Background: Individuals with high blood pressure in India often miss essential follow-up visits. Missed visits contribute to gaps across the hypertension care continuum and preventable cardiovascular disease. Widespread misconceptions around hypertension care and treatment may contribute to low follow-up attendance rates, but to date, there is limited evidence of the effect of interventions to debunk such misconceptions on health-seeking behavior. We conducted a randomized controlled trial to measure whether combining information debunking commonly-held misconceptions with a standard reminder reduces missed follow-up visits among individuals with high blood pressure and investigated whether any observed effect was moderated through belief change. Methods: We recruited 388 patients with uncontrolled blood pressure from the outpatient wards of two public sub-district hospitals in Punjab, India. Participants randomly assigned to the intervention arm received two WhatsApp messages, sent 3 and 1 days before their physician-requested follow-up visit. The WhatsApp message began with a standard reminder, reminding participants of their upcoming follow-up visit and its purpose. Following the standard reminder, we included brief debunking statements aimed at acknowledging and correcting common misconceptions and misbeliefs about hypertension care seeking and treatment. Participants in the control group received usual care and did not receive any messages. Results: We did not find evidence that the enhanced WhatsApp reminders improved follow-up visit attendance (Main effect: 2.2 percentage points, p-value = 0.603), which remained low across both treatment (21.8%, 95% CI: 15.7%, 27.9%) and control groups (19.6%, 95% CI: 14.2%, 25.0%). Participants had widespread misconceptions about hypertension care but our debunking messages did not successfully correct these beliefs (p-value = 0.187). Conclusions: This study re-affirms the challenge of continuity of care for chronic diseases in India and suggests that simple phone-based health communication methods may not suffice for changing prevalent misconceptions and improving health-seeking behavior. Trial registration: The trial began on July 18th. We registered the trial on July 18th (before recruitment began), including the main outcomes, on the German Clinical Trial Register [Identifier: DRKS00029712] and published a pre-analysis plan in the Open Science Framework [osf.io/67g35]. [ABSTRACT FROM AUTHOR]

A meta-analysis including all relevant randomized controlled trials was conducted to compare soft bandage, splint and cast as the treatment of torus fracture. PubMed, Scopus, and Web of Science databases were searched in January 2023. Two comparisons were made: (1) splint versus cast, and (2) bandage versus rigid immobilization (i.e. splint or cast). Main outcomes were pain, clinical healing of the fracture and return to activities. Secondary outcomes were adverse events (skin issues, problems with cast/splint/bandage) and patient/parental satisfaction. Seven studies with 1550 patients were included. Splint was associated with higher pain scores at 3 days compared to cast (Mean difference [MD] 1.00, CI 0.06–1.94) and at 1 week (MD 1.46, CI 0.84–2.08, moderate-certainty evidence), but faster return to activities (at 3 weeks RR 1.77, CI 1.09–2.88, at 4 weeks RR 1.44, CI 1.11–1.82, moderate-certainty evidence). All torus fractures heal clinically within 3–4 weeks (low-certainty evidence). Bandage may lead to slightly higher pain score (MD 0.35, CI 0.04–0.66, moderate-certainty evidence) at first day after treatment compared to rigid immobilization, but no evidence of a difference was found in later time points. In conclusion, soft bandage or removable wrist splint seem to be optimal first-line treatment of distal forearm torus fracture. [ABSTRACT FROM AUTHOR]

Background: Tai Chi (TC) holds a unique and valued place in promoting the physical and mental health of college students. Its significance is underscored by its incorporation as a compulsory physical education course in every university in China. TC, with its rich tradition, places a strong emphasis on posture control as a core sports ability. However, the students in Tai Chi Elective Course (TCEC) have very poor posture control ability. This study protocol investigates the potential of Tan Tui (TT) to address these issues, as TT is a fundamental skill for beginners of traditional Chinese martial arts and has a track record of enhancing lower limb strength and balance, making it a promising choice for improving posture control in TCEC. Methods/design: To investigate the impact of different intensities of TT exercises on posture control in TCEC students, we have designed a randomized, double-blind, parallel-controlled trial. Seventy-six students in the TCEC will be randomly divided into low-intensity Tan Tui (LTT), medium-intensity Tan Tui (MTT), and high-intensity Tan Tui exercises group (HTT) and control group (CON), each with 19 people. The LTT group, MTT group, and HTT group will be given different intensity of TT exercises, and the CON group will be given regular TCEC. The intervention period will be 6 weeks (2 times a week, 20 min each time). At baseline (before), 4 weeks of intervention (middle), and 6 weeks of intervention (after), the Unipedal Stance Test (UST), the Star Excursion Balance Test (SEBT), 60°/s angular velocity knee joint flexion and extension relative peak torque (RPT), and knee joint position perception (KJPP) will be evaluated. Discussion: This is the first randomized controlled trial protocol from the perspective of training intensity to evaluate the effect of different intensity of TT exercises on posture control of students in TCEC. Should our research reveal a significant intervention effect, the results will offer preliminary, higher-quality evidence supporting the positive impact of varying intensities of Tan Tui exercises on posture control in TCEC students. Trial registration: Chinese Clinical Trial Registry ChiCTR2000039109. Registered on October 17, 2020. [ABSTRACT FROM AUTHOR]

Background: Approximately onethird of cancer survivors encounter challenges reintegrating into the workforce, often experiencing involuntary unemployment and/or partial or full work disability following diagnosis and treatment. Returning to paid employment presents evident challenges due to uncertainties regarding work ability, perceived employer discrimination, and a lack of support, thereby risking social exclusion. However, interventions addressing return to paid employment among unemployed and/or work-disabled cancer survivors are scarce. Here, we describe the protocol of a randomized controlled trial (RCT), including a process and economic evaluation, evaluating the effectiveness and cost-effectiveness of the PLACES (unemPLoyed cAnCEr survivors Support) intervention aimed at supporting unemployed and/or work-disabled cancer survivors returning to paid employment. Methods: A two-armed RCT with a 12-month follow-up period will be conducted. Eligible participants: (1) are of working age (18–65 years), (2) are diagnosed with cancer between 6 months and 10 years ago, (3) are unemployed and/or partially or fully work-disabled, (4) have completed cancer treatment, and (5) are seeking paid employment and are motivated to initiate work immediately. Participants will primarily be identified through the Dutch Social Security Agency and the Netherlands Cancer Registry and recruited via healthcare professionals. Participants randomly allocated to the intervention group (n = 82) will receive the PLACES intervention: a tailored supported employment intervention based on the principles of Individual Placement and Support (IPS). This includes support in seeking, returning to, and maintaining paid employment. Participants allocated to the control group (n = 82) will receive care as usual. All participants will be asked to complete questionnaires, at baseline (T0), and after 3 (T1), 6 (T2), and 12 (T3) months of follow-up. The primary outcome is paid employment [yes/no]. Secondary outcomes are time until paid employment, change in working hours, work ability, quality of (working) life, and self-efficacy regarding return to work. Additionally, process and economic evaluations will be conducted. Discussion: We hypothesize that the PLACES intervention will be effective in obtaining paid employment, enhancing work ability, and improving quality of life. In addition, we expect the intervention to be cost-effective. If proven effective and cost-effective, actions should be taken to implement the intervention in usual care. Trial registration: NCT06028048. [ABSTRACT FROM AUTHOR]

Background: A recent meta-analysis concluded that outpatient appendectomy appears feasible and safe, but there is a lack of high-quality evidence and a randomized trial is needed. The aim of this trial is to demonstrate that outpatient appendectomy is non-inferior to conventional inpatient appendectomy in terms of overall morbi-mortality on the 30th postoperative day (D30). Methods: SAMBA is a prospective, randomized, controlled, multicenter non-inferiority trial. We will include 1400 patients admitted to 15 French hospitals between January 2023 and June 2025. Inclusion criteria are patients aged between 15 and 74 years presenting acute uncomplicated appendicitis suitable to be operated by laparoscopy. Patients will be randomized to receive outpatient care (day-surgery) or conventional inpatient care with overnight hospitalization in the surgery department. The primary outcome is postoperative morbi-mortality at D30. Secondary outcomes include time from diagnosis to appendectomy, length of total hospital stay, re-hospitalization, interventional radiology, re-interventions until D30, conversion from outpatient to inpatient, and quality of life and patient satisfaction using validated questionnaires. Discussion: The SAMBA trial tests the hypothesis that outpatient surgery (i.e., without an overnight hospital stay) of uncomplicated acute appendicitis is a feasible and reliable procedure in establishments with a technical platform able to support this management strategy. Trial registration: ClinicalTrials.gov NCT05691348. Registered on 20 January 2023. [ABSTRACT FROM AUTHOR]

Background: Tai Chi (TC) holds a unique and valued place in promoting the physical and mental health of college students. Its significance is underscored by its incorporation as a compulsory physical education course in every university in China. TC, with its rich tradition, places a strong emphasis on posture control as a core sports ability. However, the students in Tai Chi Elective Course (TCEC) have very poor posture control ability. This study protocol investigates the potential of Tan Tui (TT) to address these issues, as TT is a fundamental skill for beginners of traditional Chinese martial arts and has a track record of enhancing lower limb strength and balance, making it a promising choice for improving posture control in TCEC. Methods/design: To investigate the impact of different intensities of TT exercises on posture control in TCEC students, we have designed a randomized, double-blind, parallel-controlled trial. Seventy-six students in the TCEC will be randomly divided into low-intensity Tan Tui (LTT), medium-intensity Tan Tui (MTT), and high-intensity Tan Tui exercises group (HTT) and control group (CON), each with 19 people. The LTT group, MTT group, and HTT group will be given different intensity of TT exercises, and the CON group will be given regular TCEC. The intervention period will be 6 weeks (2 times a week, 20 min each time). At baseline (before), 4 weeks of intervention (middle), and 6 weeks of intervention (after), the Unipedal Stance Test (UST), the Star Excursion Balance Test (SEBT), 60°/s angular velocity knee joint flexion and extension relative peak torque (RPT), and knee joint position perception (KJPP) will be evaluated. Discussion: This is the first randomized controlled trial protocol from the perspective of training intensity to evaluate the effect of different intensity of TT exercises on posture control of students in TCEC. Should our research reveal a significant intervention effect, the results will offer preliminary, higher-quality evidence supporting the positive impact of varying intensities of Tan Tui exercises on posture control in TCEC students. Trial registration: Chinese Clinical Trial Registry ChiCTR2000039109. Registered on October 17, 2020. [ABSTRACT FROM AUTHOR]

Background: Patients with psoriatic arthritis (PsA) often suffer from anxiety disorders. While upadacitinib has shown effectiveness in reducing various disease activity indicators in active PsA, its impact on anxiety disorders in PsA patients needs further investigation. Methods: In this 12-week randomized, open-label, controlled trial, PsA patients with coexisting anxiety were randomly assigned to either the upadacitinib group or the adalimumab group in a 1:1 ratio. The upadacitinib group received a daily dose of 15 mg, while the adalimumab group received 40 mg every 2 weeks. The primary outcome measured the change in Hospital Anxiety Self-Assessment Scale (HADS-A) total scores after the 12-week intervention. Secondary outcomes included changes in the Health Assessment Questionnaire-Disability Index (HAQ-DI), the percentage of participants meeting the ACR20 criteria compared to baseline after 12 weeks, and the percentage of participants achieving a grade 0 or 1 in the psoriasis static Investigator's overall assessment (sPGA) at week 12 with an improvement of at least 2 points from baseline (sPGA 0/1). One-way analysis of variance (ANOVA) was used to compare the means of normally distributed variables between the upadacitinib and adalimumab groups. Discussion: The impact of upadacitinib on anxiety in PsA patients remains uncertain. This 12-week open randomized controlled trial aims to provide insights into disease progression and underscore the importance of addressing PsA-related anxiety during treatment. Trial registration: ChiCTR2400079755. Registered on January 11, 2024, with ChiCTR. https://www.chictr.org.cn/showproj.html?proj=216538 [ABSTRACT FROM AUTHOR]

Background: Higher cruciferous vegetable intake is associated with lower cardiovascular disease risk in observational studies. The pathways involved remain uncertain. We aimed to determine whether cruciferous vegetable intake (active) lowers 24-h brachial systolic blood pressure (SBP; primary outcome) compared to root and squash vegetables (control) in Australian adults with mildly elevated BP (SBP 120–160 mmHg inclusive). Methods: In this randomized, controlled, crossover trial, participants completed two 2-week dietary interventions separated by a 2-week washout. Cruciferous vegetables were compared to root and squash vegetables (~ 300 g/day) consumed with lunch and dinner meals. Participants were blinded to which interventions were the active and control. Adherence was assessed using food diaries and biomarkers (S-methyl cysteine sulfoxide (SMCSO, active) and carotenoids (control)). Twenty-four-hour brachial ambulatory SBP and secondary outcomes were assessed pre- and post each intervention. Differences were tested using linear mixed effects regression. Results: Eighteen participants were recruited (median (IQR) age: 68 (66–70); female: n = 16/18; mean ± SD clinic SBP: 135.9 ± 10.0 mmHg). For both interventions, 72% participants had 100% adherence (IQR: 96.4–100%). SMCSO and carotenoids were significantly different between interventions (mean difference active vs. control SMCSO: 22.93 mg/mL, 95%CI 15.62, 30.23, P < 0.0001; carotenoids: − 0.974 mg/mL, 95%CI − 1.525, − 0.423, P = 0.001). Twenty-four-hour brachial SBP was significantly reduced following the active vs. control (mean difference − 2.5 mmHg, 95%CI − 4.2, − 0.9, P = 0.002; active pre: 126.8 ± 12.6 mmHg, post: 124.4 ± 11.8 mmHg; control pre: 125.5 ± 12.1 mmHg, post: 124.8 ± 13.1 mmHg, n = 17), driven by daytime SBP (mean difference − 3.6 mmHg, 95%CI − 5.4, − 1.7, P < 0.001). Serum triglycerides were significantly lower following the active vs. control (mean difference − 0.2 mmol/L, 95%CI − 0.4, − 0.0, P = 0.047). Conclusions: Increased intake of cruciferous vegetables resulted in reduced SBP compared to root and squash vegetables. Future research is needed to determine whether targeted recommendations for increasing cruciferous vegetable intake benefits population health. Trial registration: Clinical trial registry ACTRN12619001294145. https://www.anzctr.org.au [ABSTRACT FROM AUTHOR]

Background: Opioid-related fatalities are a leading cause of death in Ohio and nationally, with an increasing number of overdoses attributable to fentanyl. Rapid fentanyl test strips can identify fentanyl and some fentanyl analogs in urine samples and are increasingly being used to check illicit drugs for fentanyl before they are used. Fentanyl test strips are a promising harm reduction strategy; however, little is known about the real-world acceptability and impact of fentanyl test strip use. This study investigates fentanyl test strip distribution and education as a harm reduction strategy to prevent overdoses among people who use drugs. Methods: The research team will recruit 2400 individuals ≥ 18 years with self-reported use of illicit drugs or drugs purchased on the street within the past 6 months. Recruitment will occur at opioid overdose education and naloxone distribution programs in 16 urban and 12 rural Ohio counties. Participating sites will be randomized at the county level to the intervention or non-intervention study arm. A brief fentanyl test strip educational intervention and fentanyl test strips will be provided to participants recruited from sites in the intervention arm. These participants will be eligible to receive additional fentanyl test strips for 2 years post-enrollment. Participants recruited from sites in the non-intervention arm will not receive fentanyl test strip education or fentanyl test strips. All participants will be followed for 2 years post-enrollment using biweekly, quarterly, and 6-month surveys. Primary outcomes include (1) identification of perceived barriers and facilitating factors associated with incorporating fentanyl test strip education and distribution into opioid overdose education and naloxone distribution programs; (2) differences in knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for reducing overdose risk between the intervention and non-intervention groups; and (3) differences in non-fatal and fatal overdose rates between the intervention and non-intervention groups. Discussion: Findings from this cluster randomized controlled trial will contribute valuable information about the feasibility, acceptability, and impact of integrating fentanyl test strip drug checking in rural and urban communities in Ohio and help guide future overdose prevention interventions. Trial registration: ClinicalTrials.gov NCT05463341. Registered on July 19, 2022. https://clinicaltrials.gov/study/NCT05463341 [ABSTRACT FROM AUTHOR]

Background: The progressive aging of the population has meant the increase in elderly patients requiring an urgent surgery. Older adults, especially those with frailty, have a higher risk for complications, functional and cognitive decline after urgent surgery. These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, poor quality of life and increased use of resources related to health. We aim to determine whether postoperative physical rehabilitation can prevent functional and cognitive decline and modify the posterior trajectory. Methods/design: This study is a randomized clinical trial, simple blinded, conducted in the Department of Surgery of a tertiary public hospital in Navarra (Hospital Universitario de Navarra), Spain. Patients > = 70 years old undergoing urgent abdominal surgery who meet inclusion criteria will be randomly assigned to the intervention or control group. The intervention will consist of a multicomponent physical training programme, which will include progressive and supervised endurance, resistance and balance training for 4 weeks, twice weekly sessions with a total of 8 sessions, and the group control will receive the usual care. The primary outcome measure is the change in functional (SPPB) and cognitive status (Mini-Mental State Examination) and the change of quality of life (EuroQol-5D-VAS) during the study period. The secondary outcomes are postoperative complications, length of stay, delirium, mortality, use of health resources, functional status (Barthel Index and handgrip strength tests), cost per quality-adjusted life year and mininutritional assessment. The data for both the intervention group and the control group will be obtained at four different times: the initial visit during hospital admission and at months 1, 3 and 6 months after hospital discharge. Discussion: If our hypothesis is correct, this project could show that individualized and progressive exercise programme provides effective therapy for improving the functional capacity and achieve a better functional, cognitive and quality of life recovery. This measure, without entailing a significant expense for the administration, probably has an important repercussion both in the short- and long-term recovery, improving care and functional parameters and could determine a lower subsequent need for health resources. To verify this, we will carry out a cost-effectiveness study. The clinical impact of this trial can be significant if we help to modify the traditional management of the elderly patients from an illness model to a more person-centred and functionally oriented perspective. Moreover, the prescription of individualized exercise can be routinely included in the clinical practice of these patients. Trial registration: ClinicalTrials.gov Identifier: NCT05290532. Version 1. Registered on March 13, 2022. [ABSTRACT FROM AUTHOR]

Background: Potentially curative therapy for locally advanced gastric cancer consists of gastrectomy, usually in combination with perioperative chemotherapy. An oncological resection includes a radical (R0) gastrectomy and modified D2 lymphadenectomy; generally, a total omentectomy is also performed, to ensure the removal of possible microscopic disease. However, the omentum functions as a regulator of regional immune responses to prevent infections and prevents adhesions which could lead to bowel obstructions. Evidence supporting a survival benefit of routine complete omentectomy during gastrectomy is lacking. Methods: OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Eligible patients are operable (ASA < 4) and have resectable (≦ cT4aN3bM0) primary gastric cancer. Patients will be 1:1 randomized between (sub)total gastrectomy with omentum preservation distal of the gastroepiploic vessels versus complete omentectomy. For a power of 80%, the target sample size is 654 patients. The primary objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of 3-year overall survival. Secondary endpoints include intra- and postoperative outcomes, such as blood loss, operative time, hospital stay, readmission rate, quality of life, disease-free survival, and cost-effectiveness. Discussion: The OMEGA trial investigates if omentum preservation during gastrectomy for gastric cancer is non-inferior to complete omentectomy in terms of 3-year overall survival, with non-inferiority being determined based on results from both the intention-to-treat and the per-protocol analyses. The OMEGA trial will elucidate whether routine complete omentectomy could be omitted, potentially reducing overtreatment. Trial registration: ClinicalTrials.gov NCT05180864. Registered on 6th January 2022. [ABSTRACT FROM AUTHOR]

Background: Individuals with spinal cord injury (SCI) often suffer from neuropathic pain which is often disabling and negatively affects function, participation, and quality of life (QoL). Pharmacological treatments lack efficacy in neuropathic pain reduction hence studying alternatives to drug treatment is necessary. Preclinical evidence of various aerobic exercises has shown positive effects on neuropathic pain but scientific studies investigating its effect in the SCI human population are limited. Methodology: This study is a double-blind, parallel, two-group, randomized controlled trial with an interventional study design that aims to evaluate the effectiveness of aerobic exercise program on neuropathic pain and quality of life (QoL) in individuals with chronic paraplegia. Thirty individuals with chronic paraplegia with the neurological level of injury from T2 to L2 will be recruited from the rehabilitation department at a super specialty hospital based on the inclusion criteria. Using a 1:1 allocation ratio, the participants will be randomly assigned to one of the two groups. The intervention group will perform high-intensity interval training (HIIT) aerobic exercise using an arm ergometer based on their peak heart rate, and the control group will perform free-hand arm aerobic exercise. In both groups, the intervention will be delivered as 30-min sessions, four times a week for 6 weeks. Outcome measures: International Spinal Cord Injury Pain Basic Data Set Version 3.0 will be used for diagnosing and assessing neuropathic pain and its interference with day-to-day activities, mood, and sleep. The International Spinal Cord Society (ISCoS) QoL basic data set will be used to assess QoL, and 6-min push test distance will be used to assess peak heart rate and aerobic capacity. Discussion: The effectiveness of the aerobic exercise program will be assessed based on the changes in neuropathic pain score and its interference with day-to-day activities, mood, sleep, QoL, and aerobic capacity after 3 weeks mid-intervention and after 6 weeks post-intervention. The trial will provide new knowledge about the effectiveness of the aerobic exercise program in improving neuropathic pain and QoL in individuals with chronic paraplegia. Trial registration: Clinical Trials Registry-India CTRI/2023/08/056257. Registered on 8 August 2023. [ABSTRACT FROM AUTHOR]

A single-blind, randomized controlled trial comparing oxycodone and fentanyl for patient-controlled intravenous analgesia (PCIA) after laparoscopic hysteromyomectomy found comparable pain relief between the two groups. The study included 60 participants, with NRS scores for pain at rest and when moving showing no significant differences between oxycodone and fentanyl groups at various time points postoperatively. Self-rating depression scale scores were also similar between the groups at 48 h. However, patients' satisfaction with PCIA was higher in the oxycodone group, with 73.3% reporting being very satisfied compared to 36.7% in the fentanyl group. Additionally, the oxycodone group had fewer incidences of headaches within 48 h postoperatively compared to the fentanyl group. These findings suggest that oxycodone may offer comparable pain relief, higher patient satisfaction, and fewer headaches for patients undergoing laparoscopic hysteromyomectomy compared to fentanyl, making it a suitable option for postoperative pain management in this population. Clinical trial registration number The study was registered with CHICTR.org, ChiCTR2100051924. [ABSTRACT FROM AUTHOR]

The results of a prospective, multi-institutional randomized trial developed to assess the equality of sublobar resection versus standard lobectomy were first published in 1995. They concluded that, compared with lobectomy, sublobar resections did not show any significant improvement either in terms of postoperative morbidity and mortality nor in terms of late post-resectional cardiorespiratory function. Moreover, due to the higher mortality and local recurrence rate related to sublobar resection, lobectomy had to be judged as the best surgical option for patients diagnosed with peripheral early-stage non-small-cell lung cancer. Since then, lobectomy has been considered the best surgical option for fit patients suffering from early-stage non-small cell lung cancer. In 2022 and 2023, three non-inferiority randomized trials were published, comparing lobectomy with the sublobar resection in T1a N0 patients whose tumors were up to 2 cm in size. Although presenting some important differences, all three trials met their primary endpoints, disclosing the non-inferiority of sublobar resections in terms of overall and disease-free survival. This narrative review aims to compare the newly published results of these trials as well as to report results from recent non-randomized studies on this topic. [ABSTRACT FROM AUTHOR]

Background: In susceptible hosts, SARS-CoV2-induced hyperinflammation accounts for an increased mortality. The search of adjuvant immunomodulatory therapies has been ongoing ever since the pandemic outbreak. Aim: Our purpose was to evaluate the efficacy of cyclosporin A (CsA) as an add-on therapy to the standard of care (SoC) in patients with severe COVID-19 pneumonia. Methods: We conducted a randomized clinical trial in patients admitted to eight Spanish tertiary hospitals. Patients were stratified into two severity categories and randomized in a 1:1 ratio to receive a corticosteroid-based standard therapy with or without CsA. The primary endpoint was FiO2 recovery by Day 12 without relapses. Results: 109 patients were included and randomized, and 98 of them considered for the mITT population (51 assigned to the CsA + SoC group and 47 to the SoC group). A total of 35 (68.6%) patients from the CsA + SoC group and 32 (71.1%) patients from the SoC group reached the primary endpoint in the mITT analysis. No differences were found after stratification into age groups, in the severity level at admission, or in a combination of both. Overall, the time to FiO2 normalization was 7.4 days vs. 7.9 days in the experimental and control groups, respectively. Global mortality was 8.2%. Severe adverse events were uncommon and equally distributed between arms. Conclusion: The addition of CsA did not show differences over a corticosteroid-based treatment in the clinical course of the included patients. A better identification of candidates who will benefit from receiving immunomodulatory drugs is necessary in future studies. [ABSTRACT FROM AUTHOR]

Background/Objectives: In osteopathy, it becomes necessary to produce high-quality evidence to demonstrate its effectiveness. The aim of this meta-research study is to assess the reporting quality of RCTs published in the osteopathic field. Methods: The protocol was preliminarily registered on the "Open Science Framework (OSF)" website. For reporting, we considered the PRISMA 2020 checklist. We included all the RCTs, published between 2011 and 2023, investigating the effectiveness of Osteopathic Manipulative Treatment (OMT) in any possible condition. The search process was conducted on four major biomedical databases including PubMed, Central, Scopus and Embase. A data extraction form was implemented to collect all relevant information. The completeness of reporting was calculated as the percentage of adherence to the CONSORT checklist; the Cochrane ROB 2 tool was considered to assess the risk of bias (RoB) in the following five major domains: randomization (D1), interventions (D2), missing data (D3), outcome measurement (D4), selective reporting (D5). Results: A total of 131 studies were included and the overall adherence was 57%, with the worst section being "other information" (42%). Studies with a lower RoB showed higher adherence to the CONSORT. The "results" section presented the highest differences as follows: D1 (−36.7%), D2 (−27.2%), D3 (−21.5%) and D5 (−25.5%). Significant correlations were also found between the preliminary protocol registration, higher journal quartile, publication in hybrid journals and the completeness of reporting (β: 19.22, CI: 14.45–24.00, p < 0.001; β: 5.41; CI: 2.80–8.02, p ≤ 0.001; β: 5.64, CI: 1.06–10.23, p = 0.016, respectively). Conclusions: The adherence to the CONSORT checklist in osteopathic RCTs is lacking. An association was found between a lower completeness of reporting and a higher RoB, a good journal ranking, publication in hybrid journals and a prospective protocol registration. Journals and authors should adopt all the strategies to adhere to reporting guidelines to guarantee generalization of the results arising from RCTs. [ABSTRACT FROM AUTHOR]

Background: Thyroid disorders, including hypothyroidism, hyperthyroidism, and autoimmune thyroid diseases (AITDs) such as Hashimoto's thyroiditis and Graves' disease, are prevalent endocrine disorders with significant global health impacts. Emerging evidence suggests that vitamin D, known for its role in bone health and calcium metabolism, may also influence immune function and thyroid health. Objective: This study aimed to evaluate the efficacy of vitamin D supplementation in improving thyroid function and reducing autoimmune activity in individuals with thyroid disorders. Methods: This double-blind, randomized controlled trial (RCT) involved 200 participants diagnosed with thyroid disorders, including hypothyroidism, hyperthyroidism, and AITDs. Participants were randomly assigned to receive either vitamin D supplementation (50,000 IU/week for 8 weeks, followed by 2,000 IU/day for 10 months) or a placebo for 12 months. Primary outcomes included changes in serum 25-hydroxyvitamin D [25(OH)D] levels, thyroid function tests (TSH, Free T4, Free T3), and thyroid autoantibodies (anti-TPO, antiTG). Secondary outcomes included improvements in clinical symptoms and quality of life. Data were analyzed using SPSS version 25.0. Results: Participants in the intervention group exhibited a significant increase in serum 25(OH)D levels (from 18.5 ± 4.3 ng/mL to 35.2 ± 6.2 ng/mL, p < 0.001). This increase was associated with significant reductions in TSH levels (-1.2 ± 0.8 mIU/L, p < 0.001) and thyroid autoantibodies (anti-TPO: -30 ± 12 IU/mL, p < 0.001; anti-TG: -25 ± 10 IU/mL, p < 0.001). Improvements in Free T4 and Free T3 levels were also observed in the intervention group (p < 0.001). The control group showed no significant changes in these parameters. Participants in the intervention group reported greater improvement in clinical symptoms and quality of life. Conclusion: Vitamin D supplementation significantly improves thyroid function and reduces autoimmune activity in individuals with thyroid disorders, particularly those with hypothyroidism and AITDs. These findings suggest that vitamin D may serve as an effective adjunctive therapy in managing thyroid disorders. Further research is needed to confirm these results and explore the long-term benefits of vitamin D supplementation in this population. [ABSTRACT FROM AUTHOR]

Chronic low back pain (CLBP) is a prevalent musculoskeletal disorder that significantly impairs daily functioning and quality of life. Exercise therapy, particularly core stabilization exercises and Back School programs, are commonly used interventions for CLBP management. This study aims to compare the effectiveness of these two exercise programs in reducing pain, improving functional disability, and enhancing lumbar spine range of motion in patients with CLBP. Methods: This randomized controlled trial included 40 participants with CLBP, aged 35 to 60 years, from the physiotherapy outpatient department of Deccan Hospital, Hyderabad. Participants were randomly assigned to Group A (Back School program) or Group B (core stabilization exercises), with 20 participants in each group. Both interventions were administered four times a week over a 4-week period. Outcome measures, including the Visual Analogue Scale (VAS), Roland-Morris Disability Questionnaire (RMDQ), and lumbar spine range of motion (TROM), were assessed at baseline and post-intervention. Data analysis included paired and independent t-tests, with significance set at p≤0.05. Results: Both groups showed significant improvements in all outcome measures. Group A's mean VAS score decreased from 7.4 to 5.52, RMDQ score from 16.65 to 9.45, and TROM increased from 1.585 degrees to 2.09 degrees. Group B demonstrated greater improvements, with VAS decreasing from 7.2 to 2.4, RMDQ from 16.6 to 6.75, and TROM increasing from 1.53 degrees to 2.51 degrees. Group B's improvements were significantly greater across all measures (p < 0.0001). Conclusion: Core stabilization exercises resulted in superior outcomes compared to the Back School program, suggesting they may be a more effective intervention for managing CLBP. These findings support the use of core stabilization exercises as a primary therapeutic approach in CLBP management. [ABSTRACT FROM AUTHOR]

Background: Antibiotic-associated diarrhea (AAD) is a prevalent adverse effect of antibiotic therapy, disrupting the gut microbiota and leading to gastrointestinal complications. Probiotics have been suggested as a preventive measure against AAD, but comprehensive clinical trials are needed to confirm their efficacy and elucidate the underlying microbiological mechanisms. Objective: This study aimed to evaluate the efficacy of a multi-strain probiotic formulation in preventing AAD in adult patients undergoing antibiotic therapy, focusing on the impact on gut microbiota composition and immune response. Methods: A double-blind, placebo-controlled randomized trial was conducted over 12 months in a tertiary care hospital in North India. Two hundred adult patients receiving antibiotic therapy were randomly assigned to receive either a multi-strain probiotic formulation (Lactobacillus rhamnosus GG, Bifidobacterium lactis, and Saccharomyces boulardii) or a placebo. The primary outcome was the incidence of AAD during and up to 4 weeks’ post-antibiotic therapy. Secondary outcomes included changes in gut microbiota composition, assessed through 16S rRNA sequencing, and immune response, measured by fecal IgA and cytokine levels. Stool samples were collected at baseline, end of therapy, and 4 weeks’ post-therapy. Statistical analysis compared incidence rates, microbiota changes, and immune markers between groups. Results: The probiotic group exhibited a significantly lower incidence of AAD (15%) compared to the placebo group (35%) (p < 0.05). The probiotic group also maintained higher levels of beneficial bacteria (Lactobacillus and Bifidobacterium) and lower levels of pathogenic bacteria (Clostridioides difficile). Immune response markers indicated a significant increase in fecal IgA levels and a favorable cytokine profile (IL-10 and TNF-α) in the probiotic group compared to the placebo group. Discussion: The findings demonstrate that multi-strain probiotics significantly reduce the incidence of AAD by preserving gut microbiota balance and enhancing immune function. This study supports existing literature, such as McFarland (2006) and Snydman (2008), and provides detailed microbiological and immunological insights into probiotic action. Our results align with other randomized controlled trials and highlight the importance of probiotics in clinical practice to prevent AAD. Conclusion: Probiotics, particularly multi-strain formulations, are effective in preventing AAD by maintaining gut microbiota integrity and boosting immune responses. These findings advocate for the use of probiotics as a complementary therapy during antibiotic treatment to mitigate adverse gastrointestinal effects. Further research should explore personalized probiotic therapies based on individual microbiota profiles. [ABSTRACT FROM AUTHOR]

Pain often occurs after root canal treatment due to unavoidable mechanical or chemical damage. The purpose of the present study was to investigate the efficacy of a nickel-titanium (NiTi) device combined with ultrasonic irrigation and multiple antibiotic creams in the treatment of periapical inflammation of deciduous teeth, so as to improve the understanding of root canal treatment and optimize clinical practice. Evaluation of efficacy was conducted using X-rays and the Visual Analog Scale. This treatment significantly reduced pain and also improved patient compliance and treatment outcomes. The findings of the present study may have scientific and clinical significance for optimizing root canal treatment in pediatric dentistry and requires further in-depth research in clinical practice. These outcomes may provide potential new ideas and directions for improving patients' quality of life and the efficacy of clinical treatment and have further impacts on future related research and medical practice. [ABSTRACT FROM AUTHOR]

Objective: To examine the effects of an empowerment-based interprofessional lifestyle intervention program among people at risk of type 2 diabetes on knowledge, skills, and confidence in self-management, health, psychological well-being, and lifestyle characteristics, and to explore the participants' perceptions of participating in the intervention. Design and methods: In line with the Medical Research Council complex interventions research methods framework, we conducted a randomized controlled trial with embedded qualitative interviews in primary healthcare clinics in Norway between 2019–2021. Of the patients at risk (The Finnish Diabetes Risk Score Calculator (FINDRISC) ≥15 or Body Mass Index (BMI) ≥30) 142 accepted the invitation, and 14 participants from the intervention group participated in individual interviews after the 12-month follow-up. Our primary outcome was the Patient Activation Measure (PAM-13). Secondary outcomes were EQ-5D-5L, EQ-VAS, WHO-Overall health, WHO-Overall QOL, weight, height, waist circumference, and regularity of physical activity. We used thematic analysis to analyse the qualitative data. Results: There was no clinically relevant differences of neither the primary nor the secondary endpoints between intervention and control group. As to the qualitative data, we identified two distinct features: 'Meaningful perspectives on lifestyle changes' and 'Lifestyle change is not a linear process due to challenges faced along the way' putting ownership of their choices in life into picture. Conclusion: The negative results of the RCT stand in contrast to the findings given by the participants voices, perceiving the intervention as a key eye opener placing their health challenges in perspective. How to interpret these seemingly conflicting findings of participants being seen, heard, and understood, helping them to take more conscious ownership of their choices in life, and at the same time demonstrating no improvements in symptoms or measures, is a dilemma that needs further exploration. We should be careful to implement interventions that do not demonstrate any effects on the quantitative outcomes. [ABSTRACT FROM AUTHOR]

Background: Otitis media with effusion (OME) is a common disease in ear, nose, and throat clinics characterized by aural fullness and hearing loss and mainly caused by eustachian tube dysfunction (ETD). Tympanostomy tube insertion (TTI) is a conventional surgical treatment option that can alleviate symptoms but does not provide a definitive cure, and it is prone to recurrence. Balloon dilation eustachian tuboplasty (BDET) has become a novel procedure for the treatment of ETD, demonstrating significant potential in addressing the aforementioned limitations. However, it is not widely available in the clinic and few high-quality randomized clinical trials was conducted to investigate its long-term efficacy and security in OME. Therefore, the purpose of this study is to verify the efficacy of BDET combined with TTI for patients with OME and its prospects for providing a definitive cure. Methods and analysis: This is a prospective, parallel-group, single-blind, randomized controlled prospective trial. Totally 124 patients with OME will be randomized into either group A or B. Group A will receive conventional therapy (TTI) while group B will use BDET therapy in addition to TTI. Outcome assessments will take place at baseline and at the 3rd, 6th, 12th, and 24th months after surgery. The primary outcome is eustachian tube function, which will be measured by the eustachian tube dysfunction questionnaire (ETDQ-7) and eustachian tube score (ETS). The secondary outcomes include middle ear function, hearing situation, and quality of life, which will be measured by acoustic impedance measurement, pure-tone audiometry, and Chinese-version Chronic Ear Survey (CCES). The main analysis of change in the outcomes will use mixed-model with repeated measures (MMRM) analyses of variance (ANOVAs). Discussion: This is the first prospective trial in Chinese populations that aims to validate the long-term efficacy and safety of BDET-combined TTI therapy in patients with OME. This parallel-group, single-blind, randomized controlled trial may provide an opportunity to decrease the recurrence rate of OME and explore a definitive cure for patients with OME. This trial's rigorous design enhances the reliability of the findings, ensuring a robust answer to the research question. In the future, the research team will further expand upon the clinical evidence and applications of the BDET combined therapy. Trial registration: Chinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452. [ABSTRACT FROM AUTHOR]

Background: Epilepsy and other seizure disorders account for a high disease burden in Germany. As a timely diagnosis and accurate treatment are crucial, improving the management of these disorders is important. Outside of Germany, outpatient long-term video EEGs (ALVEEGs) have demonstrated the potential to support the diagnosis and management of epilepsy and other seizure disorders. This study aims to evaluate the implementation of ALVEEGs as a new diagnostic pathway in eastern parts of Germany to diagnose epilepsy and other seizure disorders and to assess if ALVEEGs are equally effective as the current inpatient-monitoring gold standard, which is currently only available at a limited number of specialized centers in Germany. Methods: ALVEEG is a prospective, multicenter, randomized controlled equivalence trial, involving five epilepsy centers in the eastern states of Germany. Patients will be randomized into either intervention (IG) or control group (CG), using a permuted block randomization. The sample size targeted is 688 patients, continuously recruited over the trial. The IG will complete an ALVEEG in a home setting, including getting access to a smartphone app to document seizure activity. The CG will receive care as usual, i.e., inpatient long-term video-EEG monitoring. The primary outcome is the proportion of clinical questions being solved in the IG compared to the CG. Secondary outcomes include hospital stays, time until video EEG, time until diagnosis and result discussion, patients' health status, quality of life and health competence, and number and form of epilepsy-related events and epileptiform activity. Alongside the trial, a process implementation and health economic evaluation will be conducted. Discussion: The extensive evaluation of this study, including an implementation and health economic evaluation, will provide valuable information for health policy decision-makers to optimize future delivery of neurological care to patients affected by epilepsy and other seizure disorders and on the uptake of ALVEEG into standard care in Germany. Trial registration: German Clinical Trials Register (DRKS00032220), date registered: December 11, 2023. [ABSTRACT FROM AUTHOR]

Background: This randomized clinical trial protocol aimed to investigate the comparative efficacy of an enhanced recovery after surgery (ERAS) protocol versus traditional perioperative care programs in patients with intradural extramedullary spinal tumors. Methods: The study included 180 patients aged 18–80 years, who were randomly assigned to two groups: Group A receiving traditional perioperative care and Group B receiving accelerated rehabilitation perioperative care. The nurse responsible for patient care was informed of the group assignment, but the patients themselves remained blinded to the intervention. The primary outcome measure was the Karnofsky Performance Scale score, which assessed functional status. The secondary outcomes included the Japanese Orthopedic Association Scale, Numeric Pain Rating Scale, length of postoperative hospital stay, duration of urethral catheterization, patient satisfaction questionnaire, and complication rates. Follow-up assessments were conducted telephonically 1 month, 3 months, and 6 months after the surgery. Discussion: This study protocol provided a structured approach to assess the potential benefits of ERAS during the perioperative period for patients with intradural extramedullary tumors, aiming to improve patient outcomes and overall care efficiency. Trial registration: This study has been registered with the China Clinical Trials Registry (Project No: ChiCTR2200063347). Registered on September 5 2022. [ABSTRACT FROM AUTHOR]

Background: To evaluate transparency practices in randomized controlled trials (RCTs) in dentistry. Methods: This meta-research study included RCTs in dentistry regardless of topic, methods, or level of detail reported. Only studies in English were considered. We searched PubMed for RCTs in dentistry published in English from December 31, 2016, to December 31, 2021. The screening was performed in duplicate, and data extracted included journal and author details, dental specialty, protocol registration, data and code sharing, conflict of interest declaration, and funding information. A descriptive analysis of the data was performed. We generated maps illustrating the reporting of transparency items by country of the corresponding author and a heat table reflecting reporting levels by dental specialty. Results: A total of 844 RCTs were included. Only 12.86% of studies reported any information about data and code sharing. Protocol registration was reported for 50.36% of RCTs. Conflict of interest (83.41%) and funding (71.68%) declarations were present in most studies. Conflicts of interest and funding were consistently reported regardless of country or specialty, while data and code sharing had a low level of reporting across specialties, as well as low dissemination across the world. Protocol registration exhibited considerable variability. Conclusions: Considering the importance of RCTs for evidence-based dentistry, it is crucial that everyone who participates in the scientific production and dissemination process actively and consistently promotes adherence to transparent scientific standards, particularly registration of protocols, and sharing of data and code. [ABSTRACT FROM AUTHOR]

Background: Osteoarthritis (OA) contributes increasingly to disability worldwide. There is ample high-quality research on the treatment of knee and hip OA, whereas research on surgical and non-surgical treatment in hand OA is sparse. Limited evidence suggests that education and exercise may improve pain, function, stiffness, and grip strength in hand OA. The established surgical options in hand OA have disadvantages. Prostheses preserve motion but have a high complication rate, whereas fusions decrease function due to limited movement. There is an unmet need for high-quality research on treatment options for hand OA and a need for the development of effective and safe movement-sparing therapies. This study aims to compare the effects of a motion-preserving surgical treatment (denervation of the proximal interphalangeal (PIP) joint) with a patient education and exercise program on patient-reported outcomes and objective function in painful PIP OA. Methods: In this parallel-group, two-armed, randomized, controlled superiority trial (RCT), 90 participants are assigned to surgical PIP joint denervation or education and exercise. Pain on load 1 year after intervention is the primary outcome measure. Secondary outcome measures include pain at rest, Patient-Rated Wrist and Hand Evaluation (PRWHE), HQ8 score, EQ5D-5L, objective physical function, complications, two-point discrimination, Mini Sollerman, consumption of analgesics, and the need for further surgery. Assessments are performed at baseline, 3 and 6 months, and 1 year after intervention. Discussion: There are no previous RCTs comparing surgical and non-surgical treatment in PIP OA. If patient education plus exercise or PIP denervation improve function, these treatments could be implemented as first-line treatment options in PIP OA. However, if denervation does not achieve better results than non-surgical treatment, it is not justified to use in PIP OA. Trial registration: Prospectively registered in ClinicalTrials.gov (NCT05980793) on 8 August 2023. URL https://classic.clinicaltrials.gov/ct2/show/NCT05980793. [ABSTRACT FROM AUTHOR]

Acute myocardial infarction is a silent killer for people worldwide, especially older adults who often experience atypical symptoms, causing late decision-making and a high mortality rate. The unrecognition of atypical symptoms, unconcerned about their risk, and not knowing how to deal with this critical situation are the barriers to a quick decision to visit the emergency department and delaying treatment, resulting in serious adverse outcomes. Therefore, specific and effective health education among older adults is needed. This double-blinded randomized controlled trial explored the effectiveness of health education by applying a role-play promoting decision-making ability program when expecting acute myocardial infarction occurrence among community-dwelling older adults. The participants were 96 community-dwelling older adults in central northeastern Thailand. We collected data between November 2021 and April 2022. The multi-stage sampling was applied to include participants. The intervention was the role-play promoting decision-making ability program and home visit. Outcomes were measured a week before attending and after finishing the intervention. T-tests, Mann–Whitney U test, Chi-square, and Wilcoxon Signed Rank test compared the outcomes between and within groups. Moreover, adjusted analysis was also demonstrated. Results revealed that participants who attended the program improved their knowledge, belief, and decision-making; only perceived susceptibility did not show improvement. Moreover, after demonstrating an adjusted analysis, the program participants had better knowledge about symptoms, perceived benefits, barriers, self-regulation, possible calling 1669, and first action. In conclusion, a role-play promoting decision-making ability program can promote knowledge, belief, and decision-making when expecting acute myocardial infarction occurrence among community-dwelling older adults. This study proved that role-play is one strategy to promote the program's effectiveness by inducing attention before giving older adults health information. Nurses and other healthcare professionals can implement this program as part of standard practice. Clinical Trial Registration Number: TCTR20210928004 on 28/09/2021. [ABSTRACT FROM AUTHOR]

Introduction: Suburban population is increasingly growing in Iran. People in the suburbs usually have limited sexual information and there are limited studies into their sexual issues. This study aims the effect of sexual education (SE) based on the Sexual Health Model (SHM) on sexual functioning among women living in the suburbs. Methods: This is a randomized controlled trial with two parallel groups. Seventy-six women will be selected through simple random sampling from healthcare centers in suburban areas and will be allocated to a control group (n = 38) and an intervention group (n = 38) with a randomization ratio of 1:1. Participants in the intervention group will receive SHM-based SE in three120 min weekly sessions which will be held using the lecture, question-and-answer, group discussion, and educational booklet methods. Data will be collected through a demographic and midwifery characteristics questionnaire, the Female Sexual Function Index, the Depression Anxiety Stress Scale, and the Sexual Quality of Life-Female, and will be analyzed through the analysis of covariance as well as the independent-sample t, the paired-sample t, and the Chi-square tests. Discussion: We hope this study provides a clear framework for decision-makers and healthcare providers to provide appropriate policies and interventions for SE and thereby improve the sexual health of women in the suburbs. Trial registration: This study was registered in the Iranian Registry of Clinical Trials on 2024.03.05 (code: IRCT20231121060133N1). [ABSTRACT FROM AUTHOR]

Background: Anxiety and mood disorders are the main cause of illness in people under the age of 25, accounting for 45% of the global disease burden, whereas 4.6% of teenagers aged 15 to 19 are predicted to experience anxiety. Pakistan country, with a population of 200 million, has the worst mental health indicators and fewer than 500 psychiatrists. Despite the existence of various treatments for anxiety, this goes unrecognized and untreated. Due to a lack of awareness, evaluation, prevention, and interventional programs related to being implemented among adolescents in Pakistan, there is a rise in mental health issues in the earlier years of life. It calls for a critical need for indigenous, evidence-based interventions. The present study aimed to evaluate the feasibility of cognitive behavioral therapy (CBT)-based interventions to reduce anxiety symptoms among school children in Pakistan. Methods: This study was a pre-post design, two-arm, single-blinded, feasibility, randomized controlled trial. Thirty-four participants (experimental group, n = 17; control group, n = 17) were recruited from four semi-government schools in Rawalpindi with a mean age of 15 (M = 15, SD = 0.73). Two instruments Beck Anxiety Inventory for Youth (BAI-Y II) and BASC-3 Behavioural and Emotional Screening System Student (BESS-SF) were used to assess the severity of symptoms. Participants in the intervention arm received eight-group therapy CBT sessions. A two-way factorial analysis was used to examine the efficacy of CBT in reducing symptom severity. Results: This study's findings showed that in comparison to the wait-list control group, CBT successfully improved anxiety symptoms among school children while enhancing their social skills. Conclusion: This study will help improve the treatment for anxiety in Pakistan by prioritizing school-based intervention and group-based CBT intervention. Trial registration: The trial has been registered at the American Economic Association's registry for randomized controlled trials. RCT ID: AEARCTR-0009551. Registered 2022–07-04. [ABSTRACT FROM AUTHOR]

Background: Returning to work after long-term sick leave can be challenging, particularly in small- and medium-sized enterprises (SMEs) where support may be limited. Recognizing the responsibilities and challenges of SME employers, a web-based intervention (hereafter the SME tool) has been developed. The SME tool aims to enhance the employer's intention and ability to support the sick-listed employee. Based on the Self-Determination Theory, it is hypothesized that this intention is enhanced by intervening in the employer's autonomy, competences, and relatedness targeted at, e.g., communication with sick-listed employee, involvement of other stakeholders, and practical support. This is achieved by means of providing templates, communication videos, and information on legislation. This article describes the design of an effect and process evaluation of the SME tool. Methods: A randomized controlled trial (RCT) with a 6-month follow-up will be conducted with a parallel-group design with two arms: an intervention group and a control group. Sick-listed employees (≤ 8 weeks) of SMEs (≤ 250 employees) at risk of long-term sick leave and their employers will be recruited and randomly allocated as a dyad (1:1). Employers randomized to the intervention group receive unlimited access to the SME tool, while those in the control group will receive care as usual. The primary outcome is the satisfaction of the employee with the return to work (RTW) support provided by their employer. Secondary outcomes include social support, work performance, and quality of work life at the employee level and self-efficacy in providing RTW support at the employer level. Outcomes will be assessed using questionnaires at baseline and 1, 3, and 6 months of follow-up. Process evaluation measures include, e.g., recruitment and use of and perceived usefulness of the SME tool. Additionally, semi-structured interviews with employers, employees, and occupational physicians will explore the interpretation of the RCT results and strategies for the national implementation of the SME tool. Discussion: The SME tool is hypothesized to be valuable in addition to usual care helping employers to effectively support the RTW of their long-term sick-listed employees, by improving the employers' intention and ability to support. Trial registration: ClinicalTrials.gov, NCT06330415. Registered on February 14, 2024. [ABSTRACT FROM AUTHOR]

Distracted driving is responsible for nearly 1 million crashes each year in the United States alone, and a major source of driver distraction is handheld phone use. We conducted a randomized, controlled trial to compare the effectiveness of interventions designed to create sustained reductions in handheld use while driving (NCT04587609). Participants were 1,653 consenting Progressive® Snapshot® usage-based auto insurance customers ages 18 to 77 who averaged at least 2 min/h of handheld use while driving in the month prior to study invitation. They were randomly assigned to one of five arms for a 10-wk intervention period. Arm 1 (control) got education about the risks of handheld phone use, as did the other arms. Arm 2 got a free phone mount to facilitate hands-free use. Arm 3 got the mount plus a commitment exercise and tips for hands-free use. Arm 4 got the mount, commitment, and tips plus weekly goal gamification and social competition. Arm 5 was the same as Arm 4, plus offered behaviorally designed financial incentives. Postintervention, participants were monitored until the end of their insurance rating period, 25 to 65 d more. Outcome differences were measured using fractional logistic regression. Arm 4 participants, who received gamification and competition, reduced their handheld use by 20.5% relative to control (P < 0.001); Arm 5 participants, who additionally received financial incentives, reduced their use by 27.6% (P < 0.001). Both groups sustained these reductions through the end of their insurance rating period. [ABSTRACT FROM AUTHOR]

Background: Preterm infants are at high risk for retinopathy of prematurity (ROP), with potential life-long visual impairment. Low fetal hemoglobin (HbF) levels predict ROP. It is unknown if preventing the HbF decrease also reduces ROP. Methods: BORN is an ongoing multicenter double-blinded randomized controlled trial investigating whether transfusing HbF-enriched cord blood-red blood cells (CB-RBCs) instead of adult donor-RBC units (A-RBCs) reduces the incidence of severe ROP (NCT05100212). Neonates born between 24 and 27 + 6 weeks of gestation are enrolled and randomized 1:1 to receive adult donor-RBCs (A-RBCs, arm A) or allogeneic CB-RBCs (arm B) from birth to the postmenstrual age (PMA) of 31 + 6 weeks. Primary outcome is the rate of severe ROP at 40 weeks of PMA or discharge, with a sample size of 146 patients. A prespecified interim analysis was scheduled after the first 58 patients were enrolled, with the main purpose to evaluate the safety of CB-RBC transfusions. Results: Results in the intention-to-treat and per-protocol analysis are reported. Twenty-eight patients were in arm A and 30 in arm B. Overall, 104 A-RBC units and 49 CB-RBC units were transfused, with a high rate of protocol deviations. A total of 336 adverse events were recorded, with similar incidence and severity in the two arms. By per-protocol analysis, patients receiving A-RBCs or both RBC types experienced more adverse events than non-transfused patients or those transfused exclusively with CB-RBCs, and suffered from more severe forms of bradycardia, pulmonary hypertension, and hemodynamically significant patent ductus arteriosus. Serum potassium, lactate, and pH were similar after CB-RBCs or A-RBCs. Fourteen patients died and 44 were evaluated for ROP. Ten of them developed severe ROP, with no differences between arms. At per-protocol analysis each A-RBC transfusion carried a relative risk for severe ROP of 1.66 (95% CI 1.06–2.20) in comparison with CB-RBCs. The area under the curve of HbF suggested that HbF decrement before 30 weeks PMA is critical for severe ROP development. Subsequent CB-RBC transfusions do not lessen the ROP risk. Conclusions: The interim analysis shows that CB-RBC transfusion strategy in preterm neonates is safe and, if early adopted, might protect them from severe ROP. Trial registration: Prospectively registered at ClinicalTrials.gov on October 29, 2021. Identifier number NCT05100212. [ABSTRACT FROM AUTHOR]

Background: Heart failure (HF) is a debilitating disease with worsening symptoms and family caregiving burden. HF affects more than 8 million Americans. West Virginia has the highest HF death rate in the U.S. and limited healthcare services. This study tested whether the family HF palliative and end-of-life care intervention (FamPALcare) improved patient and caregiver outcomes at 3- and 6-month study endpoints. Methods: This study used a randomized controlled trial design. Patients with HF and their caregivers were randomly assigned together to the intervention (n = 21) or control (n = 18) group. The intervention included five telephone coaching sessions on the HF home, palliative, and end-of-life care. The outcome data collected at baseline and at 3 and 6 months were from the patients' (a) HF-related health status and depression/anxiety scale scores; and from caregivers' (b) caregiving burden and depression/anxiety scale scores; and (c) anonymous ratings on the 11-item FamPALcare helpfulness scale, completed by the intervention participants. Results: The mean age of the patients was 65.66 (SD = 13.72) years, and 67% were White males. The mean age of the caregivers was 62.05 (SD = 13.14) years, and 77% were White females. Compared to the controls, patients in the intervention group had significantly greater scores for HF-related health status (p <.05) and lower depression/anxiety scores at 6 months, the study endpoint. The family caregivers in the intervention group had significantly lower scores on caregiving burden (p <.05) and depression/anxiety (p <.01) at 3 months. The mean helpfulness rating was M = 4.46 out of 5 (SD = 0.49). Conclusions: The FamPALcare intervention was found to be effective at improving patient HF-related health status and reducing caregiver burden and improving both patient and caregiver depression and anxiety scores. The FamPALcare HF intervention was found feasible and consistently delivered (fidelity). The FamPALcare intervention's cost-effectiveness and helpfulness ratings information will be used to plan for subsequent clinical trials. Trial registration: ClinicalTrials.gov NCT04153890, Registered on 4 November 2019, https://clinicaltrials.gov/ct2/show/NCT04153890. [ABSTRACT FROM AUTHOR]

Background: Venous thromboembolism (VTE) is a preventable medical condition which has substantial impact on patient morbidity, mortality, and disability. Unfortunately, adherence to the published best practices for VTE prevention, based on patient centered outcomes research (PCOR), is highly variable across U.S. hospitals, which represents a gap between current evidence and clinical practice leading to adverse patient outcomes. This gap is especially large in the case of traumatic brain injury (TBI), where reluctance to initiate VTE prevention due to concerns for potentially increasing the rates of intracranial bleeding drives poor rates of VTE prophylaxis. This is despite research which has shown early initiation of VTE prophylaxis to be safe in TBI without increased risk of delayed neurosurgical intervention or death. Clinical decision support (CDS) is an indispensable solution to close this practice gap; however, design and implementation barriers hinder CDS adoption and successful scaling across health systems. Clinical practice guidelines (CPGs) informed by PCOR evidence can be deployed using CDS systems to improve the evidence to practice gap. In the Scaling AcceptabLE cDs (SCALED) study, we will implement a VTE prevention CPG within an interoperable CDS system and evaluate both CPG effectiveness (improved clinical outcomes) and CDS implementation. Methods: The SCALED trial is a hybrid type 2 randomized stepped wedge effectiveness-implementation trial to scale the CDS across 4 heterogeneous healthcare systems. Trial outcomes will be assessed using the RE2-AIM planning and evaluation framework. Efforts will be made to ensure implementation consistency. Nonetheless, it is expected that CDS adoption will vary across each site. To assess these differences, we will evaluate implementation processes across trial sites using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation framework (a determinant framework) using mixed-methods. Finally, it is critical that PCOR CPGs are maintained as evidence evolves. To date, an accepted process for evidence maintenance does not exist. We will pilot a "Living Guideline" process model for the VTE prevention CDS system. Discussion: The stepped wedge hybrid type 2 trial will provide evidence regarding the effectiveness of CDS based on the Berne-Norwood criteria for VTE prevention in patients with TBI. Additionally, it will provide evidence regarding a successful strategy to scale interoperable CDS systems across U.S. healthcare systems, advancing both the fields of implementation science and health informatics. Trial registration: Clinicaltrials.gov – NCT05628207. Prospectively registered 11/28/2022, https://classic.clinicaltrials.gov/ct2/show/NCT05628207. [ABSTRACT FROM AUTHOR]

Objective: Intimate partner violence (IPV) perpetrators with alcohol and/or other drug use problems (ADUPs) have been identified as one of the main high-risk and highly resistant groups of perpetrators requiring special attention in intervention programs for IPV perpetrators. This randomized controlled trial (RCT) aimed to evaluate whether an individualized motivational plan adjusted to ADUPs (IMP-ADUPs) was superior to standard motivational strategies (IMP) in reducing ADUPs, and IPV and increasing treatment adherence in IPV perpetrators. Method: Data from a full sample of IPV perpetrators (n = 140) and a subsample of participants with ADUPs (n = 55) were collected at pre- and post-intervention and 12-month follow-up. Final outcomes included alcohol, cocaine, and cannabis use, self-reported IPV, risk of recidivism assessed by facilitators, and official IPV recidivism. Proximal outcomes included treatment adherence (stage of change, intervention dose, active participation, and dropout). Results: Both intent-to-treat (ITT) and per-protocol (PP) analyses were conducted. The IMP-ADUPs condition was superior to the IMP in reducing alcohol use at post-intervention in both the full sample and ADUPs subsample. The full sample of participants in the IMP-ADUPs condition were in a more advanced stage of change post-intervention and showed increased active participation during the intervention process than IMP participants. All participants were in a more advanced stage of change at post-intervention and reduced their alcohol use and their risk of recidivism at post-intervention and 12-month follow-up. Conclusions: These results underscore the need to develop individualized treatment approaches to address participants' risks and needs and promote their motivation to change. [ABSTRACT FROM AUTHOR]

Aim To investigate the effect of dipeptidyl peptidase-4 inhibitor (DPP-4i) on serum creatinine (Cr) in patients with type 2 diabetes mellitus (T2DM). Methods A systematic search was performed across databases of PubMed, Embase, Cochrane Library and Web of Science, and randomized controlled trials (RCT) of DPP-4i therapy for regulating Cr in T2DM patients was included. A fixed-effect or random-effect model was used for data fitting, heterogeneity was quantitatively evaluated according to the index of I², and sensitivity analysis and publication bias testing were performed by using the standard methods. Results After searching the database through the system, 12 RCTs were included, with a total of 2 276 participants. Due to the potential heterogeneity, a random effect model was used for data fitting. DPP-4i treatment could mildly increase Cr levels in T2DM patients (WMD: 0. 15 mg / L, 95% CI: 0. 03 ~ 0. 27, I² = 18%, P= 0. 02), and the results showed statistical differences. According to sensitivity testing, the results of Meta-analysis were relatively reliable. No publication bias was observed according to Begg’ s and Egger’ s tests. Conclusions The use of DPP-4i for hypoglycemic treatment in T2DM patients may result in mild elevation of blood Cr levels. Further multicenter studies with larger samples are needed in the future to explore the clinical significance of DPP-4i treatment induced changes in Cr levels. [ABSTRACT FROM AUTHOR]

Advancing transformative change for sustainability requires population‐wide behavior change. Yet, many behavioral interventions tackling environmental problems only examine average effects on the aggregate, overlooking the heterogeneous effects in a population. We developed and preregistered a novel audience segmentation approach to test the diverse impact of conservation messaging on reducing demand for exotic pets (private action ‐ i.e., desire to own exotic pets or visit wildlife entertainment places) and fostering citizen engagement for system‐wide change (civic action ‐ e.g., signing a petition or participating in a protest against the exotic pet trade). Through an online survey with US participants (n = 2953), we identified 4 population segments (early adopters, early majority, late majority, and laggards), representing varying levels of commitment to wildlife conservation and then randomly assigned each segment to one of 3 messaging conditions. Messages highlighting negative consequences of the exotic pet trade and the power of collective action for system change effectively promoted private action among all segments except early adopters (ηp2 = 0.005). Among civic actions, only the collective action message motivated early adopters and the early majority to sign petitions (φC = 0.193 and φC = 0.097, respectively). Furthermore, the 4 segments showed distinct reasoning for action and inaction on wildlife conservation, with certain relational values, such as care, serving as both motivations and barriers to action. These findings highlight the need for targeted behavioral interventions across diverse populations. [ABSTRACT FROM AUTHOR]

Background: Chronic back pain affected 619 million people globally in 2020 which accounts for a heavy disease burden causing tremendous productivity losses. Current therapies including ibuprofen, duloxetine, and opioids might cause side effects and even severe drug use disorders. Therefore, a non‐pharmacologic therapy with better or equivalent efficacy and fewer side effects is needed. Methods: We did a multi‐center, single‐blinded, randomized, positive drug controlled, clinical trial. Patients with chronic back pain in moderate severity were randomized into receiving hot stone massage or flurbiprofen plaster group. Both interventions were 2 weeks with a follow‐up of 4 weeks. The primary outcome was the change in the score of the Global Pain Scale (GPS) from baseline to week 2. Secondary outcomes included Numerical Rating Scale (NRS), Chronic Pain Acceptance Questionnaire (CPAQ), Pain Self‐Efficacy Questionnaire (PSEQ), Hospital Anxiety and Depression Scale (HADS), and Short Form‐36 (SF36) from baseline to week 2 and week 6. Exploratory outcome assessment included the muscle thickness measured by ultrasound. Any adverse event was monitored throughout the study period. Results: A total of 120 patients were enrolled in this trial. At 2 weeks GPS decreased significantly in the hot stone massage group compared to the flurbiprofen group (difference between groups = ‐8.1 points, 95% confidence interval [CI] ‐15.8 to ‐0.3, p = 0.047). Moreover, hot stone massage also showed more improvement at 2 weeks compared to flurbiprofen, including NRS (‐0.5 points, 95% CI ‐1.0 to ‐0.1, p = 0.029), PSEQ (5.4 points, 95% CI 0.5 to 10.2, p = 0.030), and mental component of Short Form‐36 (SF‐36) (1.7 points, 95% CI 0.4 to 2.9, p = 0.010), but not in CPAQ (p = 0.131), HADS (p = 0.303 for depression, p = 0.399 for anxiety), or SF‐36 (p = 0.129 for physical component, p = 0.246 for social component, p = 0.076 for fatigue component). A total of two participants in the hot stone massage group reported mild pain on skin surface when receiving the procedure at the first intervention session. [ABSTRACT FROM AUTHOR]

Background. Despite technical advancements, patients with sequential or diffuse coronary lesions undergoing percutaneous coronary intervention (PCI) have an increased risk of cardiovascular events at follow-up. We aimed to analyze the utility of a SyncVision/iFR (S-iFR)-guided PCI strategy versus an angiography-guided strategy in patients with this type of lesions. Methods. Randomized, multicenter, controlled, and open-label trial to compare S-iFR versus angiography-guided PCI in patients with sequential or diffuse angiographic coronary stenosis (ClinicalTrials.gov identifier: NCT04283734). The primary endpoint was the implanted stent length. The main secondary endpoint was targeting vessel failure (TVF) at one year. Results. A total of 100 patients underwent randomization, with 49 patients assigned to the S-iFR group and 51 to the angiography-guided PCI group. There were no differences between groups regarding clinical and anatomical characteristics. The baseline iFR was 0.71 ± 0.16 vs. 0.67 ± 0.19 (p = 0.279) in the S-iFR and angiography group, respectively. The mean lesion length was 42.3 ± 12 mm and 39.8 ± 12 (p = 0.297). The implanted stent length was 32.7 ± 17.2 mm in the S-iFR group and 43.1 ± 14.9 mm in the angiography group (mean difference, −10.4 mm; 95% confidence interval [CI], −16.9 to −4.0; p = 0.002). At one year, target vessel failure (TVF) occurred in four patients: three (6.1%) in the S-iFR group vs. one (1.9%) in the angiography group (p = 0.319). Conclusions. Among patients with sequential or long diffuse coronary lesions, a S-iFR-guided PCI strategy resulted in a reduction of the total stent length compared to an angiography-guided PCI strategy. A nonsignificant increase in TVF was observed in the S-iFR group. [ABSTRACT FROM AUTHOR]

Noninferiority clinical trials are crucial for evaluating the effectiveness of new interventions compared to standard interventions. By establishing statistical and clinical comparability, these trials can be conducted to demonstrate that a new intervention is not significantly inferior to the standard intervention. However, selecting appropriate noninferiority margins and study designs are essential to ensuring valid and reliable results. Moreover, employing the Consolidated Standards of Reporting Trials (CONSORT) statement for reporting noninferiority clinical trials enhances the quality and transparency of research findings. This article addresses key considerations and challenges faced by investigators in planning, conducting, and interpreting the results of noninferiority clinical trials. [ABSTRACT FROM AUTHOR]

This systematic review and meta-analysis of randomized controlled trials (RCTs) with trial sequential analysis (TSA) aimed to comprehensively evaluate and compare the efficacy of the prophylactic administration of tropisetron in the prevention of the incidence of post-operative nausea and vomiting (PONV) in patients undergoing surgery under general anesthesia. This study was registered with PROSPERO (CRD42024372692). RCTs comparing the efficacy of the perioperative administration of tropisetron with that of a placebo, other anti-emetic agents, or a combination of anti-emetic injections were retrieved from the databases of Ovid-MEDLINE, Ovid-EMBASE, the Cochrane Central Register of Controlled Trials, and Google Scholar. The frequency of rescue anti-emetic use (RA) and the incidence of PON, POV, and PONV (relative risk [RR]: 0.718; 95% confidence interval [CI] 0.652–0.790; I2 = 0.0, RR: 0.587; 95% CI 0.455–0.757; I2 = 63.32, RR: 0.655; 95% CI 0.532–0.806; I2 = 49.09, and RR: 0.622; 95% CI 0.552–0.700; I2 = 0.00, respectively) in the tropisetron group were lower than those in the control group; however, the incidence of complete response (CR) was higher in the tropisetron group (RR: 1.517;95% CI 1.222–1.885; I2 = 44.14). TSA showed the cumulative Z-curve exceeded both the conventional test and trial sequential monitoring boundaries for RA, PON, POV, and PONV between the tropisetron group and the control group. Thus, the prophylactic administration of tropisetron exhibited superior efficacy in the prevention of PON, POV, and PONV. Furthermore, a lower incidence of RA and a higher incidence of CR were observed with its use. [ABSTRACT FROM AUTHOR]