Randomized Clinical Trial Research Articles

Reevaluating antibiotic prophylaxis: insights from a network meta-analysis on dry socket and surgical site infections.

Three databases (MEDLINE, Cochrane Library, and Scopus) were searched in December 2021 for 16 Randomised Clinical Trials (RCTs). Three reviewers reviewed the articles on oral antibiotic prophylaxis (ABP) for the prevention of surgical site infection (SSI) and dry socket (DS) after lower third molar (L3M) extraction using the PICO framework. From 1999 to 2021, RCTs involving healthy patients undergoing L3M extraction with ABP, placebo, or no therapy were included. Adverse effects (AEs) associated with antibiotic usage, along with the main outcomes (DS and SSI), were also documented. Three independent investigators selected articles based on pre-established inclusion criteria, with any disagreements resolved by consensus or additional researchers. PRISMA guidelines were followed, involving initial title and abstract screening, followed by full-text evaluation. Exclusion reasons were documented, and the most recent report was included when multiple reports on the same patients were found, with no language restrictions applied. Two investigators evaluated studies quality and quality of evidence respectively using the Cochrane Collaboration tool and GRADEpro GDT. They independently extracted data, focusing on the type of extraction and the number of extracted L3M. They also detailed the use of antibiotics, including dosage, dosage regimen, timing, and duration. Among 16 articles, 15 used a parallel arm design, while one used a crossover design. The antibiotics studied included Amoxicillin+Clavulanic acid (7 articles), Amoxicillin (6), Metronidazole (2), Azithromycin (1), and Clindamycin (2), all compared with no treatment or placebo. A pairwise meta-analysis was used to combine studies with equivalent treatment (direct estimation), and a network meta-analysis compared outcome variables across different treatments (indirect comparison). Two included articles had a low risk of bias and the level of evidence was low according to GRADE. Pooled results supported the use of antibiotics to reduce DS and SSI following L3M extraction with a number needed to treat 25 and 18, respectively. Despite the fact that ABP reduces the risk of DS and SSI, it is recommended to consider systemic conditions and individual patient risk factors before prescribing antibiotics, due to global health threat.

Veterans' perspectives on two transdiagnostic group workshops to improve military to civilian reintegration: A comparative thematic analysis.

Veterans deployed in the post-9/11 wars in Iraq and Afghanistan (Operations Enduring Freedom, Iraqi Freedom, and New Dawn) face a multitude of challenges reintegrating into civilian life after military service. There is a need for evidence-based support programs to address the wide-reaching cognitive, psychological, and physical symptoms that can impede civilian reintegration. The present study incorporates quantitative and qualitative methods to assess veterans' experiences with two reintegration treatments (Short-Term Executive Plus-Home [SH] and Present Centered Group Therapy for Reintegration [PCGT-R]) within the context of a larger randomized clinical trial. A total of 131 veterans ages 24-65 years, drawn from the SH (n = 66) and PCGT-R (n = 65) treatment arms, completed quantitative feedback forms and qualitative interviews. Quantitative surveys indicated SH was more highly rated than PCGT-R in terms of program satisfaction (p < .01), helpfulness (p = .03), and connection to other Veterans Affairs (VA) services (ps < .05). Thematic qualitative analysis indicated that both interventions provided beneficial social support and that both groups appreciated online implementation. They also revealed that SH veterans acquired more emotion regulation and impulse control skills and reported greater willingness to engage in further VA treatments, than PCGT-R veterans. Dropout did not differ significantly between groups, and the most highly cited reasons for dropout among both groups were scheduling conflict and dislike of group formats. Findings emphasize the opportunity for group and skills-based interventions focused on reintegration to increase support and access to VA care among veterans. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Effect of acupuncture on quality of life in atrial fibrillation: study protocol for a randomised controlled trial

IntroductionAtrial fibrillation (AF) is the prevalent cardiac arrhythmia and can significantly impair the quality of life (QoL). Although catheter ablation (CA) is an established treatment for AF,post-procedural complications or perceived...

Intracytoplasmic sperm injection versus conventional in vitro fertilization in infertile couples with normal total sperm count and motility: does sperm morphology matter?

Among couples with infertility and normal total sperm count and motility, can sperm morphology be used as a biomarker to identify couples who benefit more from ICSI over conventional IVF (c-IVF) on fertility outcomes? Based on this secondary analysis of a large randomized clinical trial (RCT), sperm morphology has limited value as a biomarker to identify couples who benefit more from ICSI over c-IVF on live birth, ongoing pregnancy, clinical pregnancy or total fertilization failure. Our recent RCT showed that ICSI did not result in higher live birth rates in couples with normal total sperm count and motility. It is unclear whether sperm morphology can be used as a biomarker to identify couples who benefit more from ICSI over c-IVF in this population. This was a secondary analysis of an open-label, multi-centre, RCT comparing ICSI versus c-IVF in 1064 couples with infertility and normal total sperm count and motility. In this secondary study, we evaluated the effectiveness of ICSI over c-IVF in relation to sperm morphology. Couples were eligible if they had ≤2 previous IVF/ICSI attempts, and the male partner had normal total sperm count and motility according to the fifth edition of the WHO laboratory manual for the examination and processing of human semen. Sperm morphology was measured from samples obtained during the first consultation and data for sperm morphology were available in partners of all participants in this trial. The outcomes of interest were live birth, ongoing pregnancy, clinical pregnancy, and total fertilization failure. We first conducted a logistic regression analysis with an interaction term (sperm morphology as a continuous variable by treatment (ICSI versus c-IVF)) on the four outcomes. We also used restricted cubic spline analysis to evaluate non-linear interaction and plotted the treatment effects of ICSI over c-IVF at different sperm morphology levels and the predicted probability of these outcomes in both ICSI and c-IVF groups. The median proportion of sperm with normal morphology in both groups was 3% (Interquartile range 1-6%). Live birth rates were (184/532) 34.6% for ICSI versus (166/532) 31.2% for c-IVF. No significant interaction was found between sperm morphology and treatment effect of ICSI versus c-IVF on the rates of live birth, ongoing pregnancy, clinical pregnancy, and total fertilization failure (P = 0.181, 0.153, 0.168, and 0.788 respectively). In the analyses using restricted cubic splines, no evidence of interaction between sperm morphology and the treatment effect was found. Interaction figures showed that the treatment effect of ICSI over c-IVF at different sperm morphology levels was fluctuating around no effect line, and the predicted outcomes for the two groups were mostly overlapping at different sperm morphology levels. This secondary analysis may be underpowered to detect a difference in treatment effects at different sperm morphology levels due to relatively small number of events at some sperm morphology levels. Moreover, sperm morphology assessment was performed during the first consultation, rather than on the day of randomization. In couples with infertility and normal total sperm count and motility, sperm morphology has a limited role as a biomarker to identify couples who benefit more from ICSI over c-IVF on fertility outcomes. This study was funded by My Duc Hospital, Ho Chi Minh City, Vietnam. RW was supported by an NHMRC EL Investigator Grant (GNT2009767). LNV has received speaker and conference fees from Merck, grant, speaker, conference fees from Merck Sharpe and Dohme, and speaker, conference, and scientific board fees from Ferring. TMH has received speaker fees from Merck, Merck Sharp Dohme, and Ferring. BWM reports consultancy, travel support and research funding from Merck and consultancy for Organon and Norgine. BWM holds stock from ObsEva. NCT03428919.

The effect of sevelamer on serum calcification propensity in patients with chronic kidney disease: the results of a multicentre, double-blind, placebo-controlled, randomized clinical trial

Abstract Background The serum calcification propensity test (or T50 test) might become a standard tool for the assessment of vascular calcification risk, and T50 might be a valuable biomarker in clinical trials of treatments intended to slow the progression of vascular calcification. Literature data suggest that non-calcium-containing phosphate binders can influence T50 in chronic dialyzed patients. However, it is not clear whether similar interventions are effective in patients at earlier stages of chronic kidney disease (CKD). Methods The “FGF23 Reduction efficacy of a new Phosphate Binder in CKD” (FRENCH) trial was a multi-centre, double-blind, placebo-controlled, randomized trial of sevelamer carbonate in participants with stage 3b/4 CKD. In this subanalysis of the FRENCH data, T50 and other laboratory variables (including fetuin A, and ionized and total magnesium) were measured centrally at baseline and after 12 weeks of treatment. Results A total of 96 patients were screened; 78 (55 men and 23 women) met the inclusion criteria and were randomized to receive placebo (n=39) or sevelamer carbonate (n=39). The median [interquartile range] patient age was 66 [56-72], the median eGFR was 25 [21-30] mL/min/1.73m², and the mean T50 was 335 (82) minutes. In a linear regression model, T50 was independently associated with serum ionized magnesium, fetuin-A and bicarbonate levels; and inversely associated with phosphate concentration. The within-group changes in the mean [95% confidence interval] T50 between week 0 and week 12 were not significant in the sevelamer group or the placebo group (4.6 [-13.6; 22.8] minutes (p=0.61) and 7.8 [-16.4; 32.1] minutes (p=0.51), respectively). Furthermore, we did not observe significant changes in fetuin-A and magnesium levels. Conclusion A 12-week course of the non-calcium-containing phosphate binder sevelamer carbonate was not associated with a significant change in T50 in patients with stage 3b/4 CKD. Phosphate binders might not be an effective strategy for modifying serum calcification propensity in non-dialysis-dependent patients with CKD.

Nephrology intervention to avoid acute kidney injury in patients awaiting cardiac surgery: randomized clinical trial

IntroductionCardiac surgery-associated acute kidney injury (CSA-AKI) is a well-known complication that increases morbidity and mortality rates. The objective of this study was to reduce CSA-AKI through nephrologist intervention in patients awaiting cardiac surgery.MethodsWe performed a single center, open-label, randomized clinical trial including 380 patients who underwent scheduled cardiac surgery at the Hospital de Bellvitge between July 2015 and October 2019. A total of 184 patients were evaluated by the same Nephrologist one month before the surgery to minimize the risk factors for AKI. In addition to assessments at the outpatient clinic, we also collected clinical data during hospitalization and during the first year.ResultsDespite the intervention, no differences were observed between the groups in the incidence of CSA-AKI (intervention group 26.37% vs. standard of care 25.13%, p=0.874), mortality (3.91% vs. 3.59%, p=0.999), length of Intensive Care Unit (ICU) stay (10 days [7.00;15.0] for both groups, p=0.347), or renal function after one year of follow-up (estimated glomerular filtration rate (eGFR) by CKD-EPI: 74.5 ml/min (standard deviation 20.6) vs 76.7 (20.8) ml/min, respectively, p=0.364). A reduction in the need for blood transfusion was observed in the intervention group, although the difference was not statistically significant (37.22% vs. 45.03%, p =0.155).ConclusionIn this clinical trial, nephrologist intervention in the entire population on the cardiac surgery waiting list did not show a nephroprotective benefit.Clinical trial registrationClinicalTrials.gov, identifier (NCT02643745).

Vagus Nerve Preservation for Early Distal Gastric Cancer With Monitoring and Indocyanine Green Labeling: A Randomized Clinical Trial.

Radical gastric cancer surgery can cause functional and physiological disorders due to the resection of perigastric vagus nerves. Few studies have used intraoperative neurophysiological monitoring and indocyanine green (ICG) labeling to preserve the perigastric vagus nerve and to evaluate the corresponding effects. To assess the feasibility and effects of vagus nerve preservation using neurophysiologic monitoring and ICG labeling during laparoscopic distal gastrectomy in patients with early distal gastric cancer. This open-label, prospective randomized clinical trial initially enrolled 285 patients with clinical stage cT1N0M0 distal gastric cancer from May 2022 to May 2023. This trial was conducted at Qilu Hospital of Shandong University in Jinan, China, and enrolled patients aged 18 to 80 years with histologically proven gastric adenocarcinoma scheduled for distal gastrectomy. The final follow-up examination was performed May 1, 2024. Eligible participants were randomly assigned 1:1 to vagus nerve preservation distal gastrectomy (VPG) or vagus nerve resection distal gastrectomy (VRG). The primary outcome was the incidence of postsurgical gastroparesis. Secondary outcomes included postoperative gallstone formation, quality of life, morbidity, mortality, overall survival, and disease-free survival up to 12 months postoperatively. All analyses were based on both intention-to-treat and per-protocol analyses. Of 264 patients included in the intention-to-treat analysis, the median (IQR) patient age was 58.0 (52.0-67.0) years, and 67 patients (25.4%) were female. Both the VPG and VRG groups included 132 patients. Postoperative gastroparesis occurred in 1 patient (0.8%) in the VPG group and in 10 patients (7.6%) in the VRG group. Gallstones developed in 0 patients in the VPG group and in 9 patients (6.8%) in the VRG group. As assessed by mean (SD) score on the 30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, the VRG group experienced more nausea and vomiting at 6 months postsurgery (19.38 [7.62]) than the VPG group (17.15 [9.21]) (P = .03) and had significantly higher rates of persistent appetite loss, reflux symptoms, and eating difficulties at both 6 months and 12 months than the VPG group. Differences in postoperative complications and metastasis were not significant. Neurophysiologic monitoring and ICG labeling during distal laparoscopic gastrectomy for vagus nerve preservation in patients with early distal gastric cancer are safe and feasible. Preserving the perigastric vagus nerve may retain the function of the remnant stomach and improve quality of life. Chictr.org.cn Identifier: ChiCTR2200059489.

Repairing alveolar bone defect using demineralized dentin grafts: a meta-analysis of randomized controlled trials.

The alveolar bone defect often was hardly healed naturally by the body's repair mechanism. Implant placement was the most favored option for replacing a missing tooth in the current times, and the preservation of alveolar bone was vital. Tooth components, especially dentin, were very similar to alveolar bone components and could be used for promoting the alveolar bone regeneration process in reconstructive dentistry. We exhaustively scoured multiple literature databases, such as PubMed and Embase, from inception to September 2024. The protocol for this meta-analysis was officially registered with PROSPERO (CRD42023400591). Randomized clinical trials (RCTs) that reported alveolar bone preservation through demineralized dentin grafts were chosen from the studies. We extracted both qualitative and quantitative data and evaluated statistical heterogeneity using the I2 test. The potential for publication bias was evaluated using both qualitative and quantitative methods. A visual evaluation of the funnel plot was used for the qualitative assessment, with the Begg's test and the Egger's test were used for quantitative analysis. Ultimately, 7 studies met the inclusion criteria, comprising 230 participants who were adults without systemic diseases and free from caries or peri-apical infections. Compared with the control group, the demineralized dentin matrix (DDM) group was not statistically significant for improving radiographic ridge width change (SMD - 0.09, 95% CI -0.39 to 0.22) and ISQ values (SMD 0.06, 95% CI -2.39 to 2.51). These results indicate that DDM performs comparably to the control, suggesting that it can be considered an effective alternative in achieving similar outcomes in these specific measures. The DDM grafts appear to be a feasible alternative to other biomaterials used for alveolar bone preservation. Not applicable. This study is a meta-analysis and does not involve a clinical trial. Therefore, no clinical trial number has been assigned.

Transcranial Direct Current Stimulation Combined With Repetitive Transcranial Magnetic Stimulation for Depression: A Randomized Clinical Trial.

Repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) are both recognized as effective treatments for depression when applied individually. However, it is unknown whether rTMS combined with tDCS has better efficacy in the treatment of major depressive disorder (MDD). To investigate the clinical effectiveness and safety of rTMS, tDCS, tDCS + rTMS, and sham tDCS + sham rTMS after 2 weeks of treatment in patients with MDD. This double-blind, sham-controlled randomized clinical trial was conducted from November 2021 to April 2023 at 3 hospitals in China (Kangning Hospital affiliated with Ningbo University, Lishui Second People's Hospital, and Taizhou Second People's Hospital). Adult patients (aged 18-65 years) who were diagnosed with major depressive disorder were recruited. Participants were randomly assigned to 1 of 4 interventions: active tDCS + active rTMS, sham tDCS + active rTMS, active tDCS + sham rTMS, and sham tDCS + sham rTMS. Data analysis followed an intention-to-treat approach. Patients received a 2-week course of treatment. The tDCS was administered using a 2-mA direct current stimulator with electrodes placed on the left and right dorsolateral prefrontal cortex (DLPFC). Each tDCS session lasted 20 minutes and was conducted 30 to 60 minutes prior to the rTMS session for a total of 10 sessions. The rTMS was delivered at a frequency of 10 Hz using a figure-8 coil placed on the left DLPFC, with each session consisting of 1600 pulses. Treatments were administered 5 times per week for 2 weeks. Sham treatments were performed with a pseudostimulation coil and emitted only sound. The primary outcome was the change in total score from baseline to week 2 on the 24-item Hamilton Depression Rating Scale (HDRS-24; score range: 0-52, with the highest score indicating more severe symptoms). A total of 240 participants (139 females [57.9%]; mean [SD] age, 32.50 [15.18] years) were included. As a primary outcome, patients who received active tDCS + active rTMS showed a significantly greater reduction in mean (SD) HDRS-24 total scores compared with patients in the other 3 groups (active tDCS + active rTMS: 18.33 [5.39], sham tDCS + active rTMS: 14.86 [5.59], active tDCS + sham rTMS: 9.21 [4.61], and sham tDCS + sham rTMS: 10.77 [5.67]; F3,236 = 35.79; η2 = 0.31 [95% CI, 0.21-0.39]; P < .001). This trial found that tDCS + rTMS was a more effective and safe treatment option than either the tDCS or rTMS intervention alone for patients with MDD. China Clinical Trial Registry Identifier ChiCTR2100052122.

Grief-Specific Cognitive Behavioral Therapy vs Present-Centered Therapy: A Randomized Clinical Trial.

Prolonged grief disorder (PGD) is included as a new diagnosis in international classification systems. Treatments following a cognitive behavioral model are most effective, but comparisons with active control treatments are scarce. To examine whether integrative cognitive behavioral therapy for prolonged grief (PG-CBT) is superior to present-centered therapy (PCT). This was a rater-blinded, multicenter, randomized clinical trial (stratified by center and relationship to the deceased) with enrollment from April 2017 to May 2022. The setting included 4 university outpatient clinics in Germany. Eligible participants were aged 18 to 75 years and had PGD based on the Prolonged Grief Disorder 13 (PG-13) interview. Participants were randomized 1:1 to PG-CBT and PCT. PG-CBT focused on the exposure to the worst moment of the loss and cognitive restructuring of grief-related cognitions in combination with solution-focused and experiential methods (eg, walk to the grave exercise). PCT was adapted in session length and number to PG-CBT and focused on a supportive relationship and coping with daily problems that may have arisen from the loss or grief symptoms. All outcomes were assessed at baseline, after treatment, and 12 months after randomization at follow-up. The primary outcome was a blinded assessment of the PG-13 severity score at follow-up. Secondary outcomes were self-reported depressive, somatic, and overall psychopathological symptoms. Of 544 treatment-seeking individuals experiencing bereavement, 212 eligible participants (mean [SD] age, 51.8 [13.3] years; 173 female [82%]) with PGD based on the PG-13 interview were randomized to PG-CBT and PCT (n = 106 in each condition). In the intention-to-treat analysis, both treatments yielded high reductions in PGD severity at follow-up (PG-CBT: Cohen d = 1.64; 95% CI, 1.31-1.97; PCT: Cohen d = 1.38; 95% CI, 1.09-1.66). After treatment, participants receiving PG-CBT demonstrated significantly greater reductions in PGD severity than those receiving PCT (Cohen d = 0.31; 95% CI, 0.03-0.57). At follow-up, this effect was only visible on a trend level (Cohen d = 0.28; 95% CI, -0.02 to 0.57), whereas participants in the PG-CBT group had significantly less depressive and general psychopathological symptoms. Twenty-three participants (20%) discontinued PG-CBT treatment, and 17 participants (16%) discontinued PCT. This randomized clinical trial demonstrates that PG-CBT was superior to PCT after treatment and at follow-up with regard to comorbid symptoms. Both treatments were shown to be effective and acceptable, showing the potential for dissemination and increasing patient choice. German Clinical Trials Register (DRKS) identifier: DRKS00012317.

Primary needle-knife fistulotomy versus standard transpapillary technique for cannulation of long-size papilla: a randomized clinical trial

Background: The morphology of the major papilla plays a crucial role in the selection of the cannulation method for the common bile duct (CBD) during endoscopic retrograde cholangiopancreatography (ERCP). Nevertheless, there is limited evidence available that compares the efficacy and safety of cannulation approaches in certain papilla morphologies. This study aims to assess the safety and effectiveness of two cannulation methods, including primary needle-knife fistulotomy (pNKF) and standard transpapillary (STP), in patients with long-size papilla. Methods: A total of 260 patients with intact long-size papilla were enrolled, and were randomly assigned to the pNKF or STP groups (n=130 in each group). The primary endpoint was the rate of post-ERCP pancreatitis (PEP). Biliary cannulation success rates, the duration of cannulation and the overall procedure, and the incidence of adverse events were also compared between the groups. All of the patients were hospitalized for at least 24 hours after the procedure. Results: 125 (96.2%) patients in the pNKF and 114 (87.7%) patients in the STP groups had successful primary biliary cannulation (p=0.01) and were included in the final analysis. PEP occurred in 11 patients in the STP group and 3 patients in the pNKF group (9.6% vs 2.4%, p=0.02; number needed to treat (95% confidence interval) =13.9 (7.5-83.2)). Moreover, compared to the pNKF, STP was associated with more cannulation attempts (3.4 versus 2.5, p&lt;0.001) and longer cannulation time (258 versus 187 seconds, p&lt;0.001). Conclusions: In patients with long-size papilla, pNKF is a safer, easier, and more efficient approach to gain primary biliary access than the STP technique.

Effectiveness of bioactive resin materials in preventing secondary caries and retention loss in direct posterior restorations: A systematic review and meta-analysis.

This systematic review aimed to determine whether bioactive resin materials can prevent secondary caries or enhance the longevity of direct posterior restorations. The protocol was registered in PROSPERO (CRD42024561179). The review followed PRISMA guidelines, utilizing a PICO framework. Studies were identified through searches in six databases (PubMed, Scopus, Cochrane, Embase, Scielo, Web of Science) up to May 2024. Two independent reviewers applied inclusion criteria, selecting randomized clinical trials evaluating bioactive resin composites in restorative dentistry. Data were extracted into pre-designed forms, and article quality was assessed using the CONSORT, RoB 2, and GRADE tools. Meta-analyses focused on secondary caries incidence and restoration longevity using USPHS and FDI criteria. Of 1,565 articles identified, 10 met the inclusion criteria. These studies, conducted in five countries, included 411 participants with follow-up periods ranging from 1 to 8 years. Materials evaluated included ACTIVA™ BioACTIVE, Giomer, and Cention N. Meta-analysis found no statistically significant differences between bioactive and conventional resin composites in preventing secondary caries or reducing retention loss (p > 0.05), the two primary outcomes considered in this review for assessing restoration longevity. Subgroup analysis showed no differences between follow-up periods. Bioactive materials demonstrated similar clinical performance to conventional composites in preventing secondary caries and retaining restorations, offering no additional benefit in enhancing the longevity of direct posterior restorations. This review provides evidence that bioactive resin materials offer no significant clinical advantage over traditional composites, guiding (or informing) clinicians in (or about) material selection for restorative treatments.

Modulation of neural networks and symptom correlated in fibromyalgia: A randomized double-blind multi-group explanatory clinical trial of home-based transcranial direct current stimulation.

Transcranial direct current stimulation (tDCS) might modulate neural activity and promote neural plasticity in patients with fibromyalgia (FM). This multi-group randomized clinical trial compared home-based active tDCS (HB-a-tDCS) on the left dorsolateral prefrontal cortex (l-DLPFC) or home-based sham tDCS (HB-s-tDCS), and HB-a-tDCS or HB-s-tDCS on the primary motor cortex (M1) in the connectivity analyses in eight regions of interest (ROIs) across eight resting-state electroencephalography (EEG) frequencies. We included 48 women with FM, aged 30 to 65, randomly assigned to 2:1:2:1 to receive 20 sessions during 20 minutes of HB-a-tDCS 2mA or HB-s-tDCS, over l-DLPFC or M1, respectively. EEG recordings were obtained before and after treatment with eyes open (EO) and eyes closed (EC). In the EC condition, comparing pre to post-treatment, the HB-a-tDCS on l-DLPFC decreased the lagged coherence connectivity in the delta frequency band between the right insula and left anterior cingulate cortex (ACC) (t = -3.542, p = .048). The l-DLPFC HB-a-tDCS compared to HB-s-tDCS decreased the lagged coherence connectivity in the delta frequency band between the right insula and left ACC (t = -4.000, p = .017). In the EO condition, the l-DLPFC HB-a-tDCS compared to M1 HB-s-tDCS increased the lagged coherence connectivity between the l-DLPFC and left ACC in the theta band (t = -4.059, p = .048). Regression analysis demonstrated that the HB-a-tDCS effect on the l-DLPFC was positively correlated with sleep quality. On the other hand, the HB-a-tDCS on l-DLPFC and HB-s-tDCS on M1 were positively correlated with pain catastrophizing. These results show that HB-a-tDCS affects the neural connectivity between parts of the brain that control pain's emotional and attentional aspects, which are most noticeable at lower EEG frequencies in a rest state. This effect on neural oscillations could serve as a neural marker associated with its efficacy in alleviating fibromyalgia symptoms. identifier [NCT03843203].

Abstract Su405: Effect Of A Visual Feedback Device On The Acquisition Of Cardiopulmonary Resuscitation Skills In Training Certified By The American Heart Association: Randomized Clinical Trial

Background: High-quality cardiopulmonary resuscitation (CPR) is fundamental for the success in the care of cardiorespiratory arrest. In CPR skills training, manequins with feedback on quality parameters have been employed and received varied evaluative results. The American Heart Association (AHA) encourages the use of feedback devices in CPR training; however, its effects have not been evaluated in courses certified by it. Research Questions: Training with visual feedback devices alters the learning of students in acquiring psychomotor skills in CPR? Goals: To evaluate the effect of a visual feedback device on CPR training, in AHA certified courses. Methods: A randomized clinical trial was conducted to estimate the intervention of a visual feedback device in practical CPR training for nurses, medical students and physicians in the Advanced Cardiovascular Life Support (ACLS) courses. For that, having as parameters the quality criteria determined by the AHA, we tried to compare the performance results of the trained students with objective feedback from the device and the trained students with subjective feedback from the instructor. Statistical analysis included chi-square test, Student's t test, Mann-Whitney u test, Spearman’s-rho correlation coefficient. Significance level considered was 0.05. A survey was registered with ClinicalTrials®, under resgistration NCT 04338490. Results: The sample consisted of 209 students; of these 119 (56.9%) were women, and 148 (70.8%) were physicians. The control group had 98 students, and the intervention group 111 students. The performance of students from both groups reached the criteria of quality in CPR. The group trained with a feedback device achieved, according to guidelines, better results in the rate of chest compressions, 78 (70.3%) versus 48 (49.0%), p &lt;0.01, and in return of the chest 100 (91; 100) versus 99 (78.25; 100), p &lt;0.03. As for the recommended compression fraction, 60% to 80%, both groups were above 60%; however, no student in the study reached 80%. Conclusions: The visual feedback device was effective in CPR training, improving students’ performance in the criteria of compression rates between 100 and 120/min and total return of the chest between compressions.

Abstract Su907: Post-Cardiac Arrest Potassium Abnormalities Associated With Unfavorable Functional Outcome

Background: Abnormal potassium levels are common findings in the intensive care unit (ICU) population. We aimed to determine the incidence of dyskalemias at ICU admission and their association with functional outcome in comatose patients resuscitated from cardiac arrest. Hypothesis: We hypothesized that both hypokalemia and hyperkalemia are associated with unfavorable functional outcome. Methods: Pooled data from four randomized clinical trials in comatose post-cardiac arrest patients admitted to ICU after return of spontaneous circulation (ROSC). Reference potassium levels were defined as between 3 and 4.9 mmol/L, as proposed in the Simplified Acute Physiology Score II. Favorable functional outcome was defined as a Cerebral Performance Category of 1 or 2 at 180 days. Results: We included 1133 patients (557 from HYPERION, 346 from TTH48, 120 from COMACARE and 110 from Xe-HYPOTHECA) with a median age of 64 (IQR: 55-72) years and a predominance of males (72%). Overall, 421 (36%) patients had favorable functional outcome. On admission, 221 (19.5%) patients experienced hyperkalemia and 35 (3.1%) patients experienced hypokalemia. More patients in the normokalemia group (364/877, 41.5%) had a favorable functional outcome, as compared to the hypokalemia (11/35, 31.4%) and hyperkalemia (41/221, 18.6%) groups p&lt;0.001). In a mixed-effects logistic regression model including initial rhythm, delay from collapse to ROSC, bystander cardiopulmonary resuscitation, lactate, and urea and with normokalemia as reference group, hyperkalemia was associated with higher odds for unfavorable functional outcome (OR 1.85, 95% CI 1.10-3.12, p=0.02) whereas hypokalemia was not (OR 1.36 95% CI 0.51-3.60, p=0.53). Conclusions: One fifth of unconscious cardiac arrest patients experienced dyskalemia on ICU admission. Hyperkalemia was associated with unfavorable functional outcome at 180 days compared to normokalemia, whereas hypokalemia was not an independent predictor of outcome.

Effect of Listening Music on Nulliparous Singleton Pregnancies Who Underwent Induction of Labor: A Randomized Clinical Trial.

A recent randomized clinical trial (RCT) showed that listening to music reduces the pain level and anxiety levels in women with spontaneous labor at term. The effect on pregnant women undergoing induction of labor is still unclear.This study aimed to test the hypothesis that in nulliparous women with singleton pregnancies, undergoing induction of labor at term, listening to music would reduce the pain level during labor. Parallel group, non-blinded, RCT conducted at a single center in Italy. Nulliparous women with singleton pregnancies and vertex presentation, admitted for induction of labor with either oral or vaginal prostaglandins, between 370/7 and 420/7 weeks, were randomized in a 1:1 ratio to receive music during induction of labor or no music during induction. The endpoints of the trials were the pain level during induction, and in the active phase of labor, recorded using the visual analog scale for pain, ranging from 0 (no pain) to 10 (unbearable pain). The effect of music use on each outcome was quantified as the mean difference (MD) with a 95% confidence interval (CI). During the study period, 30 women agreed to take part in the study, underwent randomization, and were enrolled and followed up. Fifteen women were randomized in the music group and 15 in the control group. No patients were lost to follow-up for the primary outcome. Pain level during the induction procedure was 8.8 ± 0.9 in the music group, and 9.8 ± 0.3 in the control group (MD -2.60 points, 95% CI -3.94 to -1.26; p < 0.01). Music during labor and delivery was also associated with decreased anxiety during the induction procedure (MD -3.80 points, 95% CI -5.53 to -2.07; p < 0.01). In nulliparous women, listening to music during the induction of labor reduces pain and anxiety levels. · Music listening has a modulatory effect on the human stress response.. · Music listening may generate beneficial changes in the autonomic nervous system and the HPA axis activity that should be conducive to the stress recovery process.. · Listening to music during induction of labor resulted in a significant lower pain..

Abstract 4112952: Developing culturally informed materials to enhance Native Hawaiians' and Pacific Islanders’ participation in clinical trials

Background: Native Hawaiians and Pacific Islanders (NHPI) suffer disproportionately from cardiometabolic disorders and are underrepresented in related clinical trials, limiting our ability to control these disorders for this population. We identified recruitment and retention barriers (complicated clinical language) and facilitators (relationship-building opportunities). Addressing recruitment and retention barriers and facilitators can increase NHPI representation in clinical trials. Goal: To develop culturally informed, educational videos and infographics to improve NHPI trust and attitudes toward research and recruitment and retention in clinical trials. Methods: The videos and infographics are based on focus group data with NHPI past clinical trial participants or staff. The videos focus on recruitment. The infographics focus on recruitment and retention. The videos address the complicated clinical language and hesitancy in disclosing information while leveraging trial outcomes relevant to NHPI health concerns and cultural inclusiveness. The infographics build on the video content. Facilitators include relationship-building opportunities, seeking healthier outcomes for future generations, relationship-building opportunities, and sharing and learning opportunities provided in clinical trials. Results: The Co-Principal Investigators, NHPI clinical trial participants, and NHPI researchers and clinicians contributed to the videos. We created a 5-minute and a 10-minute video. The videos provide 1) an overview of clinical research, 2) considerations for participating in clinical trials, and 3) reasons to participate. Researchers present the first 2 topics, while past participants provide testimonials for the third topic. The 8 infographics include 1) an overview of clinical research, 2) the importance of randomization, 3) research benefits from NHPI participation, 4) the importance of a control group, 5) clinical trial outcomes, 6) individual benefits from research participation, 7) community benefits from research participation, and 8) trust in research. Discussion: We will test the impact of these materials on trust and attitudes towards research and recruitment and retention among NHPI in a randomized clinical trial (RCT). Half of the participants (n=104) will be recruited using traditional strategies and half (n=104) using our novel strategy. Rigorous qualitative (interviews with participants) and quantitative (retention rates) analysis will be conducted.

Chlorhexidine-alcohol compared with povidone-iodine-alcohol skin antisepsis protocols in major cardiac surgery: a randomized clinical trial.

Whether skin disinfection of the surgical site using chlorhexidine-alcohol is superior to povidone-iodine-alcohol in reducing reoperation and surgical site infection rates after major cardiac surgery remains unclear. CLEAN 2 was a multicenter, open-label, randomized, two-arm, assessor-blind, superiority trial conducted in eight French hospitals. We randomly assigned adult patients undergoing major heart or aortic surgery via sternotomy, with or without saphenous vein or radial artery harvesting, to have all surgical sites disinfected with either 2% chlorhexidine-alcohol or 5% povidone-iodine-alcohol. The primary outcome was any resternotomy by day 90 or any reoperation at the peripheral surgical site by day 30. Of 3242 patients (1621 in the chlorhexidine-alcohol group [median age, 69 years; 1276 (78.7%) men] and 1621 in the povidone-iodine-alcohol group [median age, 69 years; 1247 (76.9%) men], the percentage required reoperation within 90days was similar (7.7% [125/1621] in the chlorhexidine-alcohol group vs 7.5% [121/1621] in the povidone-iodine-alcohol group; risk difference, 0.25 [95% confidence interval (CI), -1.58-2.07], P = 0.79). The incidence of surgical site infections at the sternum or peripheral sites was similar (4% [65/1621] in the chlorhexidine-alcohol group vs 3.3% [53/1621] in the povidone-iodine-alcohol group; risk difference, 0.74 [95% CI -0.55-2.03], P = 0.26). Length of hospital stay, intensive care unit or hospital readmission, mortality and surgical site adverse events were similar between the two groups. Among patients requiring sternotomy for major heart or aortic surgery, skin disinfection at the surgical site using chlorhexidine-alcohol was not superior to povidone-iodine-alcohol for reducing reoperation and surgical site infection rates.

Abstract 4124370: DAPT for 1-Month Followed by P2Y12 Inhibitor Monotherapy Versus DAPT for 12-Months After Percutaneous Coronary Intervention: A Systematic Review and Meta Analysis of Randomized Controlled Trials

Background: Dual antiplatelet therapy (DAPT) is well established as standard of care following percutaneous coronary intervention (PCI). Recent trials have shown a potential benefit in the reduction of hemorrhagic events with a shorter course of DAPT. However, the optimal duration of DAPT following PCI remains unclear. Question: Is 1 month of DAPT followed by P2Y12 inhibitor monotherapy superior to the standard 12-month DAPT regimen in terms of cardiovascular outcomes in patients post-PCI? Methods: Medline, PubMed, and Cochrane Central Register of Controlled Trials databases were searched for randomized clinical trials (RCTs) comparing 1-month vs. 12-months of DAPT followed by P2Y12 inhibitor monotherapy post-PCI. The outcomes of interest were cardiovascular death, myocardial infarction, and major bleeding. We used R version 4.1.2 (The R Foundation, 2021) to pool the data using a random-effects model. Heterogeneity was assessed with I2. Results: We included three RCTs reporting data from 22,413 patients, of whom 11,180 (49.8%) were treated with 1-month of DAPT, followed by P2Y12 inhibitor monotherapy. Follow-up ranged from 12 months to 24 months. The incidence of all-cause death (RR 1.20; 95% CI 0.95-1.51; p=0.12) and myocardial infarction (RR 0.86; 95% CI 0.71-1.05; p=0.14) were not significantly different between the groups. However, major bleeding (RR 0.51; 95% CI 0.26-0.99; p=0.048) was significantly reduced with a short course of DAPT followed by P2Y12 inhibitor monotherapy, as compared with standard 12 months of DAPT. Conclusion: Following PCI, a transition from DAPT to P2Y12 inhibitor monotherapy at 1-month is associated with a significant reduction in major bleeding as compared with standard DAPT for 12-months, with no significant change in the incidence of all-cause mortality or myocardial infarction.

Abstract 4138494: Remote Blood Pressure Monitoring and Intervention as a better and cost-effective method of Hypertension control compared to Usual care: A Systematic Review

Introduction/Background: Hypertension is a leading cause of morbidity and mortality. Despite treatment recommendations and encouragement of lifestyle changes, the actual rate of blood pressure control is still not at par. Remote intervention methods have been shown to achieve better rates of blood pressure control utilising lesser resources and lower healthcare costs. We conducted a systematic review by qualitatively evaluating the potential impact of remote monitoring and interventions compared to usual care in controlling Hypertension. Research Question: Are remote monitoring techniques and interventions better than usual in-person blood pressure checks for hypertension control? Methods: We did a comprehensive literature search of Pubmed/MEDLINE, Google scholar, Cochrane central Library, PLOS ONE, ScienceDirect and Clinicaltrials.gov to identify eligible randomised control trials and clinical trials published between July 2013 and May 2025. A Risk of Bias assessment was conducted using Cochrane Risk of Bias tools such as ROB-2 for randomised control trials and ROBINS-1 for cohort studies. This study follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: Of the 5,185 records analysed, 10 randomised control trials, 1 cohort study and 1 implementation study satisfied our inclusion criteria. Compared to usual care, remote monitoring methods showed significant difference in systolic blood pressure control at 6-12 months in 9 out of 12 studies, while 3 studies did not show any significant difference. Quality of life, physical health, mental health and drug compliance have also shown a significant positive difference in patients. Remote self monitoring interventions were found to be more cost-effective than usual care. They also reduced the load of patients seeking appointments for hypertension control thereby improving the quality of patient care. Conclusion: The management of clinical hypertension is a challenging entity. Conventional methods of regular in-office blood pressure checks are both tedious and resource consuming. Using remote monitoring methods have shown to significantly improve blood pressure control compared to routine methods. It also eliminates white-coat hypertension during follow-up blood pressure checks which leads to more appropriate interventions. Remote monitoring and intervention for hypertension control is time-effective, cost-effective and improves quality of life.