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Background and Aims: Tobacco smoking represents a major cause for preventable death and morbidity. Results from non‐randomized studies suggest that smoking cessation therapy in a residential setting might be a new viable way to facilitate smoking abstinence. We aimed to test the effects of residential multicomponent group therapy for smoking cessation compared with outpatient group therapy. Design: Prospective parallel‐group open‐label randomized superiority trial, with assessments at baseline, 6 and 12 months. Setting: Recruitment throughout Germany via media advertisements. Participants: Adult smokers (≥10 cigarettes/day) randomly assigned to residential (n = 157) or outpatient (n = 158) therapy. 51.8% female; mean age 53.2 years; mean years of smoking 34.4. Intervention and Comparator: Residential 9‐day smoking cessation group therapy comprising six daily therapy sessions and supportive interventions for cessation and daily structure embedded in the routines of a somatic rehabilitation center, compared with weekly outpatient smoking cessation group therapy (3–7 weeks) provided in routine care courses close to the participants' places of residence, both including at least 9 h of behavioral therapy. Measurements Co‐primary outcomes were self‐reported continuous 6‐ and 12‐month abstinence (hierarchically ordered). Primary analyses were conducted in the therapy‐uptake population including participants who started therapy with sensitivity analyses in the intention‐to‐treat population of all randomized participants. Findings Intervention uptake rates were 87.3% (n = 137) in the residential and 60.1% (n = 95) in the outpatient group. In the therapy‐uptake population, abstinence rates were 46.7% in the residential versus 26.3% in the outpatient group at 6 months (odds ratio [OR] = 2.46, 95% confidence interval [CI] = 1.39–4.33, P = 0.0019) and 39.4% versus 24.2% at 12 months (OR = 2.04, 95% CI = 1.14–3.64, P = 0.017). Biochemically validated abstinence rates at 12 months were 33.1% in the residential versus 17.4% in the outpatient group (OR = 2.35, 95% CI = 1.22–4.51, P = 0.011). In the intention‐to‐treat population, self‐reported and biochemically validated abstinence rates at 12 months were 34.4% in the residential versus 14.6% in the outpatient group (OR = 3.08, 95% CI = 1.77–5.34, P < 0.0001) and 28.6% versus 10.3% (OR = 3.48, 95% CI = 1.85–6.52, P = 0.0001), respectively. Conclusions: Residential therapy exclusively for smoking cessation is feasible and effective and could be a beneficial new treatment for smokers. [ABSTRACT FROM AUTHOR]

The objective of this study was to investigate the effects of self-management education integrated with text-message support (SME-TMS) on glycaemic control in individuals with type 2 diabetes. a randomized, controlled trial. Patients from two communities were randomized into the intervention group (n = 53) or the control group (n = 52). The six-month intervention included the culturally tailored diabetes education and text-messaging support for behaviour changes. The control group received treatment as usual. The primary outcome was reductions in HbA 1c and fasting blood glucose at six-month non-intervention follow-up. Secondary outcomes were reductions in body weight, body mass index (BMI), blood pressure, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol, physical activity, and health beliefs. The intervention led to substantially increase days of weekly physical activity (42% vs. 0%, P < 0.001) and health beliefs (coefficient = 7.0, 95% confidence interval [CI]: 4.4 to 9.6, P < 0.001). However, no greater reduction was found in HbA 1c at six months after the intervention, compared with the control group (0.13%, 95% CI: −0.20 to 0.46, P = 0.443). The reductions of blood pressure, TC, and LDL-C were greater in the control group than in the intervention group (all P < 0.050). Within the intervention group, participants had significant reduction in BMI, whereas the control group had greater reductions in TC and LDL-C (all P < 0.050). The SME-TMS intervention led to a greater increase in the weekly physical activity and health belief score in the older patients at 6-month follow-up than with the usual care. Further research is needed to ascertain how these benefits could be translated into favorable medium-and long-term glycaemic control. This study was registered on Chinese Clinical Trials Registry (ChiCTR2300075112). [ABSTRACT FROM AUTHOR]

Objective: To assess efficacy of Chinese medicine (CM) on insomnia considering characteristics of treatment based on syndrome differentiation. Methods: A total of 116 participants aged 18 to 65 years with moderate and severe primary insomnia were randomized to the placebo (n=20) or the CM group (n=96) for a 4-week treatment and a 4-week follow-up. Three CM clinicians independently prescribed treatments for each patient based on syndromes differentiation. The primary outcome was change in total sleep time (TST) from baseline. Secondary endpoints included sleep onset latency (SOL), wake time after sleep onset (WASO), sleep efficiency, Pittsburgh Sleep Quality Index (PSQI) and CM symptoms. Results: The CM group had an average 0.6 h more (95% confidence interval (CI): 0.3–0.9, P<0.001) TST and 34.1% (10.3%–58.0%, P=0.005) more patients beyond 0.5 h TST increment than that of the placebo group. PSQI was changed −3.3 (−3.8 to −2.7) in the CM group, a −2.0 (−3.2 to −0.8, P<0.001) difference from the placebo group. The CM symptom score in the CM group decreased −2.0 (−3.3 to −0.7, P=0.003) more than the placebo group. SOL and WASO changes were not significantly different between groups. The analysis of prescriptions by these clinicians revealed blood deficiency and Liver stagnation as the most common syndromes. Prescriptions for these clinicians displayed relative stability, while the herbs varied. All adverse events were mild and were not related to study treatment. Conclusion: CM treatment based on syndrome differentiation can increase TST and improve sleep quality of primary insomnia. It is effective and safe for primary insomnia. In future studies, the long-term efficacy validation and the exploratory of eutherapeutic clinicians' fixed herb formulas should be addressed (Registration No. NCT01613183). [ABSTRACT FROM AUTHOR]

Aims: The aim of this work was to measure the impact of P2P (i.e. peer‐to‐peer), a peer‐led smoking prevention intervention, on daily smoking prevalence of adolescents over 2 school years. Design: A cluster‐randomized controlled trial was performed over a 16‐month follow‐up (trial status: closed to follow‐up). P2P was implemented 1–3 and 13–15 months after baseline. Assessments took place at baseline and 4, 10 and 16 months after baseline. The research team, assessors and adolescents were blinded to the study‐arm assignment only at baseline. Setting: Fifteen vocational high schools in France were randomized into two clusters, using a 1:1 allocation ratio per French department (n intervention = 7, n control = 8). Participants: Participants comprised a sample of 2010 students in year 11 (i.e. 15–16 years) in vocational high schools. A total of 437 students could not be assessed at baseline (absent or left school), yielding a total sample of 1573 students (n intervention = 749, n control = 824). Intervention and comparator: The P2P programme trained voluntary students to become peer educators and design smoking prevention actions for their schoolmates in the intervention group (n = 945 students), compared with a passive control group (n = 1065 students). Measurements The primary outcome was change from baseline in the prevalence of self‐reported daily smoking (i.e. at least one cigarette per day) at 16 months. Findings The 'time × group' interaction indicated that, compared with the control group, the intervention group had statistically significantly fewer daily smokers after 16 months [odds ratio (OR) = 0.33, 95% confidence interval (CI) = 0.20, 0.53]. Similarly, compared with the control group, the intervention group had statistically significantly fewer daily smokers after 4 months (OR = 0.50, 95% CI = 0.30, 0.82) and 10 months (OR = 0.60, 95% CI = 0.37, 0.98). No adverse events of P2P2 were reported. Conclusions: A cluster‐randomized trial found evidence that the peer‐led P2P (peer‐to‐peer) smoking prevention intervention reduced the uptake of daily smoking among high school students in France over 16 months. [ABSTRACT FROM AUTHOR]

Background: Standardization of health systems often hinders client‐centered care. This study investigates whether allowing more flexibility in the planning range of the Dutch home‐based postpartum care service improves its quality of care, as innovative approach to client‐centered care. Methods: A randomized controlled trial was conducted (2017–2019), in which pregnant women who intended to breastfeed were assigned into two groups (1:1). The intervention group was allowed to receive care up to the 14th‐day postpartum, instead of the first 8–10 consecutive days ("usual care"). Primary outcome measure was the proportion of newborns still receiving exclusively breastmilk on final caring day of the service. This so‐called successful breastfeeding rate is currently used by the Dutch health sector to measure the quality of care. Secondary outcome measures were self‐care experience, overall care experience, and exclusive breastfeeding duration rate. Results: Based on data from 1275 participants, there was no difference in exclusive breastfeeding on final caring day (86,7% intervention group vs. 88,9% control group, RR: 1.03, 95% CI: 0.98–1.07). Both groups showed similar self‐care experiences. Women in the intervention group had slightly poorer overall care experience and lower exclusive breastfeeding duration rates. Conclusions: This study found no effect on the quality of care when allowing more flexibility in the planning range of home‐based postpartum care. Women can, therefore, be offered more flexibility to suit them. Given the confusion in interpreting the sector's current main quality indicator, we call for an inclusive dialogue on how to best measure the quality of home‐based postpartum care. [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]

Objective: The fragility index (FI), which is the minimum number of changes in status from "event" to "non-event" resulting in a loss of statistical significance, serves as a significant supplementary indicator for clinical physicians in interpreting clinical trial results and aids in understanding the outcomes of randomized controlled trials (RCTs). In this systematic literature survey, we evaluated the FI for RCTs evaluating Chinese herbal medicine (CHM) for irritable bowel syndrome (IBS), and explored potential associations between study characteristics and the robustness of RCTs. Methods: A comprehensive search was conducted in four databases in Chinese and four databases in English from their inception to January 1, 2023. RCTs encompassed 1:1 ratio into two parallel arms and reported at least one binary outcome that demonstrated statistical significance were included. FI was calculated by the iterative reduction of a target outcome event in the treatment group and concomitant subtraction of a non-target event from that group, until positive significance (defined as P < 0.05 by Fisher's exact test) is lost. The lower the FI (minimum 1) of a trial outcome, the more fragile the positive result of the outcome was. Linear regression models were adopted to explore influence factors of the value of FI. Results: A total of 30 trials from 2 4118 potentially relevant citations were finally included. The median FI of total trials included was 1.5 (interquartile range [IQR], 1–5), and half of the trials (n = 15) had a FI equal to 1. In 12 trials (40%), the total number of participants lost to follow-up surpassed the respective FI. The study also identified that increased FI was significantly associated with no TCM syndrome differentiation for inclusion criteria of the patients, larger total sample size, low risk of bias, and larger numbers of events. Conclusions: The majority of CHM IBS RCTs with positive results were found to be fragile. Ensuring adequate sample size, scientifically rigorous study design, proper control of confounding factors, and a quality control calibration for consistency of TCM diagnostic results among clinicians should be addressed to increase the robustness of the RCTs. We recommend reporting the FI as one of the components of sensitivity analysis in future RCTs to facilitate the assessment of the fragility of trials. [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 and aims: Offering financial incentives is effective for smoking cessation during pregnancy. We tested the effectiveness of financial incentives for maintaining postpartum cessation, comparing 12-month and 3-month incentives with each other and with usual care (UC). Design, setting and participants: This study was a pragmatic, multi-centre, three-arm randomized controlled trial involving four English, National Health Service, stop smoking services. A total of 462 postpartum women (aged ≥ 16 years) took part, who stopped smoking during pregnancy with financial incentives, validated as abstinent from smoking at end of pregnancy or early postpartum. Interventions: Interventions comprised (i) UC; (ii) UC plus up to £60 of financial voucher incentives offered to participants and £60 offered to an optional significant-other supporter, over 3 months postpartum, contingent upon validated abstinence ('3-month incentives'); or (iii) UC plus '3-month incentives' plus £180 of vouchers offered to participants over 9 months postpartum, contingent upon abstinence ('12-month incentives'). Measurements: Primary outcome: biochemically validated abstinence at 1 year postpartum. To adjust for testing all comparisons between groups with equal precision, P < 0.017 was necessary for significance. Secondary outcomes: self-reported and validated abstinence at 3 months postpartum; self-reported abstinence at 1 year postpartum. Findings: Primary outcome ascertainment: abstinence was 39.6% (63/159) 12 months incentives, 21.4% (33/154) 3 months incentives and 28.2% (42/149) UC. Adjusted odds ratios [95% confidence interval (CI)] = 12-month versus 3-month incentives OR = 2.41 (95% CI = 1.46-3.96), P = 0.001; 12 months versus UC 1.67 (1.04-2.70), P = 0.035; 3 months versus UC 0.69 (0.41-1.17), P = 0.174. Bayes factors indicated that for 12- month versus 3-month incentives and 12 months versus UC there was good evidence for the alternative hypothesis, and for 3 months versus UC there was good evidence for the null hypothesis. Conclusions: This randomized controlled trial provides weak evidence that up to £300 of voucher incentives over 12 months is effective for maintaining smoking abstinence postpartum compared with usual care. There was good evidence that 12-month incentives are superior to those over only 3 months, for which there was no evidence of effectiveness relative to usual care. [ABSTRACT FROM AUTHOR]

Resilience training has beneficial effects on the ability of undergraduate students to withstand adversity and stress. However, there are inconsistencies in the content and delivery approaches for resilience training. Given the increasing shifts towards computer‐assisted instruction, there is a need to develop and evaluate innovative approaches for resilience training. This study aimed to examine the efficacy of two versions of the Resilience Skills Enhancement (RISE) programme. A randomized controlled trial was used to evaluate the effects of blended learning (BL) and a self‐guided RISE programme on the resilience, social support, and learning outcomes of undergraduate students. One hundred and fourteen students were recruited and randomly allocated to receive either BL or the self‐guided RISE programme. The within‐group analyses indicated significant improvements in resilience scores for the BL (F = 37.74, p < 0.001) and self‐guided groups (F = 10.16, p < 0.001) with moderate (d = 0.62, 95% CI: 0.25, 1.00) to large effect sizes (d = 1.11, 95% CI: 0.71, 1.50) respectively. There were also significant differences across the three time points for social support scores for the BL (F = 4.50, p < 0.05) and self‐guided groups (F = 4.59, p < 0.05). Students in the BL group had considerable improvements in self‐efficacy of learning and performance (F = 5.42, p < 0.01) and meta‐cognitive self‐regulation scores (F = 5.91, p < 0.01). In the between‐group analyses, both BL and self‐guided RISE were comparable for resilience, social support, and learning scores (p > 0.05). The study provided preliminary evidence that both modes, BL and self‐guided RISE programme lead to positive effects on the resilience, social support, and learning scores of students. [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]

Background: Rural family caregivers (FCGs) in the United States often experience high economic costs. This randomized controlled trial compared a transitional palliative care intervention (TPC) to support FCGs of seriously ill care recipients (CRs) to an attention control condition. We evaluated the TPC's effect on healthcare use and out‐of‐pocket spending for both FCGs and CRs. Methods: TPC FCGs received teaching, guidance, and counseling via video calls for 8 weeks following CR discharge from the hospital. After discharge, a research assistant called all FCGs once a month for up to 6 months or CR death to collect self‐reported healthcare utilization (e.g., outpatient, emergency department, and hospital), out‐of‐pocket healthcare spending (e.g., deductibles and coinsurance), and health‐related travel costs (e.g., transportation, lodging, food) for FCGs and CRs. Incidence rate ratios (IRRs) were estimated using negative binomial regressions. Results: The study included 282 FCG–CR dyads across three U.S. states. Follow‐up over the 6‐month period was shortened by high CR mortality rates across both arms (29%), but was similar across arms. TPC reduced nights in the hospital for CR (IRR = 0.75; 95% confidence interval [CI] = 0.56–0. 99). Total out‐of‐pocket spending was not significantly different for TPC versus control. Across both groups, mean out‐of‐pocket spending for dyads was $1401.85, with healthcare payments contributing $1048.58 and transportation expenses contributing $136.79. TPC dyads reported lower lodging costs (IRR = 0.71; 95% CI = 0.56–0.89). Conclusions: This study contributes to evidence that palliative care interventions reduce the number of nights in the hospital for seriously ill patients. Yet, overall rural FCGs and seriously ill CRs experience substantial out‐of‐pocket economic costs in the 6 months following hospitalization. Transitional care intervention design should consider impacts on patient and caregiver spending. Clinicaltrials.gov # is NCT03339271. [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]

Background: Mindfulness practices enhance executive function skills and academic achievement, spurring interest in integrating mindfulness interventions into education. Embedding mindfulness practice into a digital math game may provide a low‐cost, scalable way to induce mindfulness and boost game‐based learning, yet this approach remains unexplored. Objectives: We investigated the learning benefits of integrating mindfulness exercises in a digital math learning game and examined how students' trait mindfulness might moderate the outcomes. Methods: Two classroom studies were conducted with 404 5th and 6th grade students from six public schools in the U.S. (nStudy 1 = 227, nStudy 2 = 177). The two randomized controlled experiments assigned students to one of the three conditions: passive control (playing the digital learning game Decimal Point), story‐enriched active control, or mindfulness‐enriched condition. Trait mindfulness, learning gains, and in‐game problem‐solving (including problem‐solving duration, error count and correctness after reminder) were assessed. Study 2 included a manipulation check to better understand the effects of the mindfulness intervention. Results: Findings showed no significant differences in learning gains, problem‐solving duration or error count among the conditions. Students' trait mindfulness did not moderate these outcomes. Mindfulness reminders in the mindfulness‐enriched game led to more correct answers after errors than jokes in the story‐enriched game. Study 2 revealed that we failed to induce higher state mindfulness through the mindfulness inductions. Conclusions: Mindfulness prompts could be especially beneficial for students experiencing frustration during gameplay, warranting more exploration for digital game‐based instruction. We highlight barriers and future directions for fostering mindfulness through computer‐based instruction in classrooms. Lay Description: What is currently known about this topic?: Researchers focus on digital games as productive learning environments for math, with potential for higher learning gains compared with traditional methods. However, results are mixed, and not all games lead to improved math outcomes.Executive function (EF) skills are crucial for math learning, and mindfulness‐based interventions show promise in enhancing EF skills in school‐aged students.Embedding mindfulness practice into a digital math game may provide a low‐cost, scalable way to induce mindfulness and, in turn, boost EF skills and game‐based learning, yet this approach remains unexplored What does this paper add?: This paper presents the results of two randomized control trials investigating the feasibility and benefits of incorporating mindfulness exercises into a digital math game designed for middle school students. Benefits are compared to those of a story‐enriched and regular version of the same digital math learning game.The paper also explores variations in the effects of the mindfulness‐enriched game based on students' initial trait mindfulness levels.We observe that listening to mindfulness inductions at the beginning of game sessions do not induce mindfulness, and therefore does not benefit math learning.We find that mindfulness prompts received after recurrent errors can be beneficial for students' problem solving. Implications of study findings for practitioners: Our study provides important information on how digital learning game designers should attempt to induce mindfulness in a digital game to promote learning.Digital learning game designers should consider incorporating mindfulness exercises into their games strategically. Presenting mindfulness inductions in audio format at the beginning of game sessions may not induce mindfulness or benefit math learning. Instead, designers should focus on integrating mindfulness prompts at moments when students encounter frustration within the learning game.Beyond embedding audio mindfulness exercises in the game, learning designers should also consider alternative technological and game features to induce mindfulness within a learning game. [ABSTRACT FROM AUTHOR]

Background and aims: Pre‐clinical studies suggest that the simultaneous blockade of the α1b and 5HT2A receptors may be effective in reducing alcohol consumption. This study aimed to assess the efficacy and safety of prazosin (α1b blocker) and cyproheptadine (5HT2A blocker) combination in decreasing total alcohol consumption (TAC) in alcohol use disorder (AUD). Design, setting and participants: This was a double‐blind, parallel group, placebo‐controlled, Phase 2, randomized clinical trial conducted in 32 addiction treatment centres in France. A total of 108 men and 46 women with severe AUD took part. Intervention: Participants were randomly assigned to one of the following 3‐month treatments: (1) low‐dose group (LDG) receiving 8 mg cyproheptadine and 5 mg prazosin extended‐release (ER) formulation daily; (2) high‐dose group (HDG) receiving 12 mg cyproheptadine and 10 mg prazosin ER daily; and (3) placebo group (PG) receiving placebo of cyproheptadine and prazosin ER. A total of 154 patients were randomized: 54 in the PG, 54 in the LDG and 46 in the HDG. Measurements The primary outcome was TAC change from baseline to month 3. Findings: A significant main treatment effect in the change in TAC was found in the intent‐to‐treat population (P = 0.039). The HDG and LDG showed a benefit in the change in TAC from baseline to month 3 compared with PG: −23.6 g/day, P = 0.016, Cohen's d = −0.44; −18.4 g/day, P = 0.048 (Bonferroni correction P < 0.025), Cohen's d = −0.36. In a subgroup of very high‐risk drinking‐level participants (> 100 g/day of pure alcohol for men and > 60 g/day for women), the difference between the HDG and the PG in the primary outcome was −29.8 g/day (P = 0.031, Cohen's d = −0.51). The high and low doses were well‐tolerated with a similar safety profile. Conclusions: A randomized controlled trial of treatment of severe alcohol use disorder with a cyproheptadine−prazosin combination for 3 months reduced drinking by more than 23 g per day compared with placebo. A higher dose combination was associated with a larger magnitude of drinking reduction than a lower dose combination while showing similar safety profile. [ABSTRACT FROM AUTHOR]

Background: One anastomosis gastric bypass (OAGB) has been proposed as an effective alternative to the current standard procedure in Switzerland, Roux-en-Y gastric bypass (RYGB). Prospective data comparing both procedures are scarce. Therefore, we performed a non-inferiority randomized controlled trial assessing the effectiveness and safety of these 2 operative techniques. Method: Eighty patients were randomized 1:1. OAGB consisted of a very long gastric pouch with a 200 cm biliopancreatic limb, RYGB of a 150 cm ante-colic alimentary and a 60 cm biliopancreatic limb, respectively. Primary endpoint was the percent excess weight loss (%EWL) at 12 months after surgery. Results: Mean %EWL at 12 months was 87.9% (SD24.4) in the RYGB group and 104.1% (SD24.6) in the OAGB group (p = 0.006). There was no mortality. The rate of marginal ulcers was higher in patients with OAGB compared to those with RYGB (p = 0.011), while the total number of late complications did not statistically differ between the two groups. Except for the remission of GERD, which was higher in the RYGB group compared to OAGB, there was no difference between the groups regarding the remission of comorbidities. OAGB showed improved glucose control compared to the RYGB after 1 year (p = 0.001). Furthermore, glucagon-like peptide-1 increase was significantly higher in OAGB at 6 weeks (p = 0.041) and 1 year after surgery (p = 0.029). Quality of life improved after both surgeries, without differences between the groups. Conclusions: %EWL 1 year after surgery was higher in OAGB than in RYGB. A better glycemic control with a higher increase in GLP-1 was observed after OAGB compared to RYGB. Trial registration: This trial is registered on ClinicalTrials.gov under the identifier NCT02601092. [ABSTRACT FROM AUTHOR]

Background: It is necessary to better understand the structural characteristics of the supraspinatus tendon and associated muscle after rotator cuff repair and in the event of retear. Purpose: To study structural differences between the repaired and contralateral shoulders 1 year after rotator cuff repair in patients who received either progressive exercise therapy (PR) or usual care (UC) in a randomized controlled trial and to investigate whether there was interaction with tendon retear and limb dominance. Study Design: Cohort study; Level of evidence, 2. Methods: Patients with surgically repaired traumatic full-thickness rotator cuff tears involving the supraspinatus tendon were included. After surgery, they were randomized to PR or UC (active from postoperative week 2 or 6, respectively). The subacromial structures (acromiohumeral distance, supraspinatus tendon thickness, and vascularity) and the supraspinatus muscle thickness were examined with ultrasound at the 1-year follow-up. Results: A total of 79 patients were included. The characteristics of the 2 intervention groups (PR and UC) were comparable, including the Western Ontario Rotator Cuff Index score and number of retears. The authors found significantly thinner supraspinatus tendon (PR, P <.001; UC, P =.003) and reduced acromiohumeral distance (PR, P =.023; UC, P =.025) in the repaired versus the contralateral shoulders in both intervention groups. For neovascularization, there was no interlimb difference in either of the groups or between groups (PR vs UC). In patients with intact tendons, there was no interlimb difference in the muscle thickness, but in patients with tendon retear the muscle was significantly thinner on the repaired side (P =.024 and P <.001, respectively). When the dominant supraspinatus tendon was repaired (both groups), it was significantly thinner than the nondominant healthy tendon, but this difference was not seen when the nondominant supraspinatus tendon was repaired (P =.006). Conclusion: One year after rotator cuff surgery, the repaired supraspinatus tendon was significantly thinner and the corresponding acromiohumeral distance was reduced. In patients with retear, the supraspinatus muscle was significantly thinner on the repaired side and early initiation of tendon-loading exercises did not affect these findings. Registration: NCT02969135 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Introduction: New therapies for resistant hypertension (RH), including renal denervation (RDN), have been studied. Aim: Access the safety and effectiveness of radiofrequency-based RDN vs pharmacological treatment for RH. Methods: A thorough literature search was conducted across PubMed, EMBASE, and the Cochrane databases, focusing on studies that compared the effects of radiofrequency-based RDN versus pharmacological treatment for RH. Treatment effects for binary and continuous endpoints were pooled and used, respectively, odds-ratio (OR) and mean differences (MD) with 95% confidence intervals (CI) to analyze continuous outcomes. Results: In the 10 included studies, involving 1.182 patients, 682 received radiofrequency-based RDN. The follow-up period ranged from 6 to 84 months. Analysis revealed that the RDN group had a significant reduction in office systolic blood pressure (BP) (MD − 9.5 mmHg; 95% CI − 16.81 to − 2.29; P = 0.01), office diastolic BP (MD − 5.1 mmHg; 95% CI − 8.42 to − 2.80; P < 0.001), 24 h systolic BP (MD − 4.8 mmHg; 95% CI − 7.26 to − 2.42; P < 0.001). For 24 h diastolic BP RDN did not have a significant reduction (MD − 2.3 mmHg; 95% CI − 4.19 to − 0.52; P = 0.012). The heterogeneity between the studies was high, visible in the funnel and Baujat plots. The OR was non-significant for non-serious adverse events, but also clinically significant for hypertensive crises and strokes for the RDN group. Conclusions: While the pharmacological regimen of 3 or more anti-hypertensive, including a diuretic, still be the first-line option for RH treatment, our results support that radiofrequency-based RDN is superior in reducing global BP and is safe. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness of an individualized nutritional education program in promoting adequate nutrient intake in pregnant women. Methods: A stratified randomized controlled trial was conducted. Participants were stratified by factors affecting the primary outcome and randomly assigned to the intervention or control groups. Intervention group participants received an individualized 30‐min booklet‐based education program in their 2nd and 3rd trimesters; the control group received usual care. The primary outcome was protein intake after the intervention, which was compared between the intervention and control groups. Secondary outcomes included comparing the amount of increase of protein before and after the intervention. Nutrient intake was measured using a self‐administered short dietary history questionnaire, and analyses of covariance and t tests were performed. Results: Of the 130 participants, 66 were assigned to the intervention group and 64 to the control group. There was no difference in protein intake between the two groups after the intervention (p =.051, 95% CI [−0.021, 12.4]). Comparing the increase in protein intake before and after intervention, the intervention group was 7.4 g/day higher than that of the control group (p =.040; F = 4.31; effect size = 0.36). Conclusions: The primary outcome, a comparison of protein intake between the groups after the program, revealed no significant differences. However, on comparing the amount of protein increase before and after the intervention, the intervention group's increase was significantly higher than that of the control group. Results indicate the potential for individualized face‐to‐face interventions for pregnant women in Japan. [ABSTRACT FROM AUTHOR]

Background: Insomnia is a highly prevalent sleep disorder frequently comorbid with mental health conditions in nurses. Despite the effectiveness of evidence-based cognitive behavioral therapy for insomnia (CBT-I), there is a critical need for alternative approaches. This study investigated whether internet-delivered mindfulness-based stress reduction (IMBSR) for insomnia could be an alternative to internet-delivered CBT-I (ICBT-I). Objective: The hypothesis was that the IMBSR would be noninferior to the ICBT-I in reducing the severity of insomnia among nurses with insomnia. Additionally, it was expected that ICBT-I would produce a greater reduction in the severity of insomnia and depression than IMBSR. Method: Among 240 screened nurses, 134 with insomnia were randomly allocated (IMBSR, n = 67; ICBT-I, n = 67). The assessment protocol comprised clinical interviews and self-reported outcome measures, including the Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), the 15-item Five Facet Mindfulness Questionnaire (FFMQ), and the Client Satisfaction Questionnaire (CSQ-I). Results: The retention rate was 55% with 77.6% (n = 104) of participants completing the study. At post-intervention, the noninferiority analysis of the ISI score showed that the upper limit of the 95% confidence interval was 4.88 (P = 0.46), surpassing the pre-specified noninferiority margin of 4 points. Analysis of covariance revealed that the ICBT-I group had significantly lower ISI (Cohen's d = 1.37) and PHQ-9 (Cohen's d = 0.71) scores than did the IMBSR group. In contrast, the IMBSR group showed a statistically significant increase in the FFMQ-15 score (Cohen's d = 0.67). Within-group differences showed that both the IMBSR and ICBT-I were effective at reducing insomnia severity and depression severity and improving mindfulness. Conclusion: Overall, nurses demonstrated high levels of satisfaction and adherence to both interventions. The IMBSR significantly reduced insomnia severity and depression, but the findings of this study do not provide strong evidence that the IMBSR is at least as effective as the ICBT-I in reducing insomnia symptoms among nurses with insomnia. The ICBT-I was found to be significantly superior to the IMBSR in reducing insomnia severity, making it a recommended treatment option for nurses with insomnia. [ABSTRACT FROM AUTHOR]

Online credit recovery will likely expand in the coming years as school districts try to address increased course failure rates brought on by the coronavirus pandemic. Some researchers and policymakers, however, raise concerns over how much students learn in online courses, and there is limited evidence about the effectiveness of online credit recovery. This article presents findings from a multisite randomized study, conducted prior to the pandemic, to expand the field's understanding of online credit recovery's effectiveness. Within 24 high schools from a large urban district, the study randomly assigned 1,683 students who failed Algebra 1 or ninth grade English to a summer credit recovery class that either used an online curriculum with in-class teacher support or the school's business-as-usual teacher-directed class. The results suggest that online credit recovery had relatively insignificant effects on student course experiences and content knowledge, but significantly lower credit recovery rates for English. There was limited heterogeneity in effects across students and schools. Non-response on the study-administered student survey and test limit our confidence in the student experience and content knowledge results, but the findings are robust to different approaches to handling the missing data (multiple imputation or listwise deletion). We discuss how the findings add to the evidence base about online credit recovery and the implications for future research. [ABSTRACT FROM AUTHOR]

With increasing age, dyslipidemia becomes a common health problem in the middle-aged and elderly population, posing a significant risk of cardiovascular disease. Aerobic exercise, as a non-pharmacological intervention, is considered to be effective in improving blood lipid levels, but the extent to which different types of aerobic exercise affect blood lipids is not clear. This study aims to investigate the effects of 12 different aerobic exercises on total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol in middle-aged and elderly people aged 45 years and over through systematic review and Bayesian network Meta-analysis of randomized controlled trials. We systematically searched relevant databases and included eligible randomized controlled trials. Bayesian network meta-analysis was used to compare the effects of 12 types of aerobic exercise on lipid levels. A total of 487 randomized controlled trials involving middle-aged and elderly people over 45 years old were included. The results of the network meta-analysis showed that all types of aerobic exercise could reduce blood lipid levels compared with no intervention in middle-aged and elderly people. In terms of total cholesterol, triglyceride, and low-density lipoprotein cholesterol, swimming had the most significant effect. For HDL cholesterol, dance showed a better effect. Studies have shown that swimming and dancing have a positive effect on improving blood lipid levels in middle-aged and elderly people. It is recommended to choose the appropriate type of exercise according to personal preference and physical condition. [ABSTRACT FROM AUTHOR]

Background Clinical trials of treatments for serious infections commonly use the primary endpoint of all-cause mortality. However, many trial participants survive their infection and this endpoint may not truly reflect important benefits and risks of therapy. The win ratio uses a hierarchical composite endpoint that can incorporate and prioritize outcome measures by relative clinical importance. Methods The win ratio methodology was applied post hoc to outcomes observed in the MERINO trial, which compared piperacillin-tazobactam with meropenem. We quantified the win ratio with a primary hierarchical composite endpoint, including all-cause mortality, microbiological relapse, and secondary infection. A win ratio of 1 would correspond to no difference between the 2 antibiotics, while a ratio <1 favors meropenem. Further analyses were performed to calculate the win odds and to introduce a continuous outcome variable in order to reduce ties. Results With the hierarchy of all-cause mortality, microbiological relapse, and secondary infection, the win ratio estimate was 0.40 (95% confidence interval [CI],.22–.71]; P =.002), favoring meropenem over piperacillin-tazobactam. However, 73.4% of the pairs were tied due to the small proportion of events. The win odds, a modification of the win ratio accounting for ties, was 0.79 (95% CI,.68–.92). The addition of length of stay to the primary composite greatly minimized the number of ties (4.6%) with a win ratio estimate of 0.77 (95% CI,.60–.99; P =.04). Conclusions The application of the win ratio methodology to the MERINO trial data illustrates its utility and feasibility for use in antimicrobial trials. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the present study was to examine the acute and chronic effects of wild blueberry supplementation on mood, executive function, and serum biomarkers of neuroplasticity, inflammation, and oxidative stress in emerging adults with moderate-to-severe depressive symptoms. Methods: In this double-blind trial, 60 emerging adults (Mage = 20.0 years, 32% male) with self-reported depressive symptoms were randomly assigned to receive a single blueberry drink (acute phase), followed by 6 weeks of daily blueberry supplementation (chronic phase), or a matched placebo drink. The primary outcome was Beck Depression Inventory-II (BDI-II) scores at 6-week follow-up. Further measures included momentary affect (PANAS-X) and accuracy on an executive function task. The data were analyzed using ANCOVAs adjusted for baseline values, sex, and habitual fruit and vegetable intake. Estimated marginal means were calculated to compare the treatment arms. Results: The blueberry drink significantly improved positive affect (p = 0.026) and executive function (p = 0.025) at 2 h post-ingestion, with change scores being positively correlated in the blueberry group (r = 0.424, p = 0.017). However, after six weeks of supplementation the reduction in BDI-II scores was greater in the placebo group by 5.8 points (95% CI: 0.8–10.7, p = 0.023). Generalized anxiety and anhedonia also decreased significantly more in the placebo group. No significant differences were found for any of the biomarkers. Conclusions: Six weeks of wild blueberry supplementation were inferior to placebo in reducing depressive symptoms. Nevertheless, the correlated improvements in positive affect and executive function after a single dose of blueberries point to a beneficial, albeit transient, psychological effect. These contrasting results suggest a biphasic, hormetic-like response that warrants further investigation. Trial registration: NCT04647019, dated 30 November, 2020. [ABSTRACT FROM AUTHOR]

Cancer-related fatigue (CRF) is unrelenting. As neither rest nor sleep ameliorates cognitive, emotional, and physical symptoms, quality of life is diminished. This study examines resistance training (RT) effectiveness on CRF in cancer survivors. The secondary aims were to identify the dose-response relationship of RT frequency, intensity, and volume on CRF in different cancer survivor populations. Systematic searches via numerous databases for RCTs were performed in June 2022. Patient-reported outcome measures (PROM), were analysed, pre-to-post intervention, using a random-effects model. The Physiotherapy Evidence Database (PEDro) scale informed methodological quality assessment. Eight studies were included (cancer survivors: breast (BCS) = 5; endometrial (ECS) = 1; prostate (PCS) = 2). Overall, RT interventions ≥ 6 weeks elicited large significant reductions in CRF for FACIT-F (SMD = 0.932, p = <0.001) and moderate significant reductions in CRF for PFS-R (SMD = −0.622, p = 0.004). Main findings indicate that RT ameliorates CRF, especially in BCS; however, individualised approaches should be advocated. Supervised training elicited the greatest positive outcomes, thus should be a pivotal part of the cancer rehabilitation pathway. Future studies should be adequately powered, undertake discrete analyses of different cancer types, and investigate chronic RT effects. Cancer-related fatigue (CRF) is debilitating and distressing, leading to reduced quality of life and function in cancer survivors. Considerable heterogeneity exists in disease histology and clinical patient presentation. Individualised resistance training (RT) is an effective, safe, and accessible intervention to mitigat:e fatigue levels, thus aid function, most notably in breast cancer survivors [ABSTRACT FROM AUTHOR]

To verify the effectiveness of experimental occupational therapy plus intensive standard rehabilitation compared to intensive standard rehabilitation alone on the reintegration to social activities of complex patients three months after hospital discharge. Patients with a score ≥ 9 on the Rehabilitation Complexity Scale at admission to an intensive rehabilitation ward were randomized to the control or experimental group. Both groups received intensive multidisciplinary rehabilitation aimed at recovering independence in the basic activities of daily life (ADL). The experimental group also received experimental occupational therapy services to address goals identified through the administration of the Canadian Occupational Performance Measure (COPM). Experimental occupational therapy began during the in-hospital phase and continued in the home-based setting. It consisted of teaching strategies, recommending aids, and providing personalized information regarding available community support. Ninety-two individuals with a mean age of 65 years (female 44.6%) were enrolled. The experimental group significantly improved participation measured by the Reintegration to Normal Living Index (mean changes 8.61, 95% CI: 1–16.23, p = 0.027). The performance and satisfaction scores of the COPM, both during hospitalization and after discharge, and independence in ADL also improved. No differences in mood disturbances were found. Early post-discharge occupational therapy integrated with multidisciplinary rehabilitation improves the social participation of complex patients. Future research should investigate the concrete feasibility of implementing this complex intervention cost-effectively and in different contexts. ClinicalTrials.gov Identifier NCT03668938 (first posted date 13/09/2018) Early post-discharge rehabilitation assists patients' transition from hospital to home by improving the management of problems they encounter. In complex patients, occupational therapy initiated during hospitalization and extended to the early post-discharge phase improves social participation, independence in basic and instrumental daily activities, and performance and satisfaction when carrying out relevant occupational activities. The strong partnership between the Occupational Therapist and the patient improves compliance to treatment, enhancing the chances of success of rehabilitation interventions. [ABSTRACT FROM AUTHOR]

Background: There is inconsistent utilisation of clinical practice guidelines (CPGs) for cardiovascular disease (CVD) screening and management by healthcare professionals to identify CVD risk factors early and to intervene using current recommendations. To address this issue, the Cardiovascular Assessment Screening Program (CASP) was developed, implemented, and evaluated. This manuscript reports on the second phase of an exploratory sequential mixed methods study that tested the effectiveness of the CASP with nurse practitioners (NPs) and patients in Canada. Methods: A two-armed, non-blinded, cluster randomised controlled trial (cRCT) compared the NP-led implementation of CASP with usual care by NPs in community practice clinics across one Canadian province. The NPs were the cluster variable as their screening practices could be affected by their educational training, resources, or other factors. NPs were eligible for inclusion in the study if they were located in different urban and rural community settings and could conduct follow-up visits with patients. NPs recruited and enrolled the patients from their own practices as participants if they were healthy individuals, aged 40–74 years, with no established CVD or vascular disease. Researchers randomly allocated the NPs (n = 10) to the intervention group (IG) or the control group (CG). Results: Eight (8) NPs and 167 patients participated in the cRCT study. Patient participant-level data were analysed by the originally assigned groups IG (n = 68) and CG (n = 99). Utilising GLM (generalized linear modeling) more IG patients (90%; n = 61) received comprehensive CVD screening compared to the CG patients (2%; n = 2), RR = 30.2, 95% CI [8.76, 103.9], p <.0001, controlling for the effect of NP and BP category. Conclusion: NP implementation of CASP was effective for comprehensive screening compared to usual care and led to identifying previously unknown CVD risk factors, calculated FRS, heart health priorities and personalised goal-setting. Trial registration: ClinicalTrial.gov ID#: NCT03170752, date of registration 2017/05/31. [ABSTRACT FROM AUTHOR]

Background: Despite the implementation of various postoperative management strategies, the prevalence of postoperative fatigue syndrome (POFS) remains considerable among individuals undergoing laparoscopic radical gastrectomy. While the N-methyl-D-aspartic acid receptor antagonist esketamine has demonstrated efficacy in enhancing sleep quality and alleviating postoperative pain, its impact on POFS remains uncertain. Consequently, the objective of this study is to ascertain whether perioperative administration of esketamine can effectively mitigate the occurrence of POFS in patients undergoing laparoscopic radical gastrectomy. Methods: A total of 133 patients diagnosed with gastric cancer were randomly assigned to two groups, namely the control group (Group C) (n = 66) and the esketamine group (Group E) (n = 67), using a double-blind method. The Group C received standardized anesthesia, while the Group E received esketamine in addition to the standardized anesthesia. The primary outcome measure assessed was the Christensen fatigue score at 3 days after the surgical procedure, while the secondary outcomes included the disparities in postoperative fatigue, postoperative pain, sleep quality, and adverse reactions between the two groups. Results: In the group receiving esketamine, the fatigue scores of Christensen on the third day after surgery were significantly lower compared to the Group C (estimated difference, -0.70; 95% CI, -1.37 to -0.03; P = 0.040). Additionally, there was a significant decrease in the occurrence of fatigue in the Group E compared to the Group C on the first and third days following surgery (P < 0.05). Also, compared to individuals who had distal gastrectomy, those who had entire gastrectomy demonstrated a higher degree of postoperative tiredness reduction with esketamine. Furthermore, the Group E exhibited reduced postoperative pain and improved sleep in comparison to the Group C. Both groups experienced similar rates of adverse events. Conclusions: The use of esketamine during the perioperative period can improve POFS after laparoscopic radical gastrectomy, without adverse reactions. Trial registration: Registered in the Chinese Clinical Trial Registry (ChiCTR2300072167) on 05/06 /2023. [ABSTRACT FROM AUTHOR]

Background Among individuals with vitamin D deficiency, daily vitamin D supplementation appears to lower risk of acute respiratory infection. However, recent trials, in different populations and using different regimens, have yielded null results. We investigated the effect of daily vitamin D supplementation (vs placebo) on risk of upper respiratory infection (URI) in older adults. Methods The VITamin D and OmegA-3 TriaL (VITAL) is a randomized, double-blind, placebo-controlled trial of supplemental vitamin D and/or omega-3 fatty acids in generally healthy men (age ≥50 years) and women (age ≥55 years). This prespecified analysis focuses on vitamin D3 (2000 IU/day) versus placebo in the 15 804 (61%) participants with baseline serum total 25-hydroxyvitamin D level. The primary outcome was self-report of a recent URI at 1-year follow-up. Results Participants had a mean age of 68 years and 51% were women; 76% were non-Hispanic White, 16% Black, and 8% other race/ethnicity. The mean 25-hydroxyvitamin D level at baseline was 31 (standard deviation, 10) ng/mL, with <12 ng/mL in 2.4%. The overall effect of vitamin D supplementation on recent URI was nonsignificant (odds ratio [OR], 0.96 [95% confidence interval {CI},.86–1.06]). In the prespecified subgroup of primary interest (<12 ng/mL and denied taking concurrent vitamin D), which had only 255 participants, vitamin D supplementation was nonsignificant (OR, 0.60 [95% CI,.28–1.30]). Statistical power to assess effect modification in other subgroups was limited. Conclusions In older adults not selected for vitamin D deficiency, supplemental vitamin D did not lower URI risk overall. Whether effects differ in subgroups requires further study. Clinical Trials Registration. NCT01169259. [ABSTRACT FROM AUTHOR]

Background and aims: Despite the high prevalence and negative effects of hazardous substance use, few young adults enter treatment. Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, has proved efficacious in promoting treatment entry. The aim of the current trial was to compare the efficacy of CRAFT with an active control for parents of young adults (aged 18–24 years) with hazardous substance use. Design: This was a randomized controlled superiority trial comparing CRAFT (n = 58) with an active control group receiving manualized counselling (n = 55), with outcome assessments at 6, 12 and 24 weeks (primary end‐point). A sequential design with a stopping rule was added post recruitment commencement. Setting: The study took place in two outpatient clinics for young adults in Stockholm, Sweden, and subsequently via video‐conference due to COVID‐19. Participants: Between October 2018 and May 2021, 113 participants (92% female) who were parents of young adults (87% male) were recruited. Recruitment was discontinued when 70% of the planned sample had been recruited, following an interim analysis of the primary outcome showing no difference between conditions. Intervention and comparator: Participants were randomized (ratio 1 : 1) to eight manual‐based individual CRAFT sessions or five individual manual‐based counselling sessions + one voluntary psychoeducative group session, delivered over maximum 14 weeks. Measurements The primary outcome measure was the rate of young adult entry in substance use treatment during the trial period (24 weeks). Findings At the 24 weeks follow‐up, 19 (33%) of CRAFT participants and 17 (31%) of counselling participants had reported young adult treatment entry, with no difference between conditions (odds ratio CRAFT versus counselling 0.84, 95% confidence interval = 0.35; 1.99, P = 0.700). Both conditions reported clinically relevant reductions in young adult substance use, but no change in participants' levels of depression, anxiety or stress. Conclusions: This trial showed no statistically significant evidence that Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, is more efficacious than manual‐based counselling regarding treatment entry for young adults. [ABSTRACT FROM AUTHOR]

Simple Summary: Head and neck cancer is associated with significant morbidity. Shoulder and neck dysfunction, weight loss, and declines in muscular strength and physical functioning are commonly seen following cancer therapies. This pragmatic randomized controlled trial involved sixty-one individuals with cancer in the head and neck region who had completed their cancer treatment. The primary aim was to assess the effectiveness of the addition of lower-body resistance exercise training to a physiotherapeutic shoulder and neck exercise protocol on fatigue-related quality of life. Findings support the benefit of the combined intervention for fatigue-related quality of life, six-minute walk test distance, upper- and lower-body muscular strength, and physical activity level. The continued improvement in treatment effect over the one-year follow-up period suggests promise from this interdisciplinary approach to bridge individuals with head and neck cancer from rehabilitation care to general exercise and physical activity. Background: Established barriers to general exercise and physical activity among individuals with head and neck cancer include dry mouth, difficulty eating, weight loss, fear of injury, comorbidities, and treatment-related symptoms of pain and fatigue. Methods/Design: A 12-week pragmatic randomized controlled trial was conducted followed by an optional supported exercise transition phase. Eligible participants were individuals with head and neck cancers who had undergone surgery and/or radiation therapy to lymph node regions in the neck. Participants were randomized to a comparison group involving a shoulder and neck physiotherapeutic exercise protocol, or to a combined experimental group comprising the shoulder and neck physiotherapeutic exercise protocol and lower-body resistance exercise training. The primary outcome of this study was fatigue-related quality of life. Results: Sixty-one participants enrolled, 59 (97%) completed the randomized trial phase, 55 (90%) completed the 24-week follow-up, and 52 (85%) completed the one-year follow-up. Statistically significant between-group differences were found in favor of the combined experimental group for the fatigue-related quality of life, fitness outcomes, and overall physical activity. Paired comparisons confirmed significant within-group improvements for both groups from baseline to one-year follow-up across most outcomes. Discussion: A group-based combined physiotherapeutic and lower-body resistance exercise program was feasible and effective. Findings are limited to individuals who had undergone a surgical neck dissection procedure. Given the complexity of head and neck cancer, further pragmatic interdisciplinary research is warranted. [ABSTRACT FROM AUTHOR]

* OBJECTIVE: To determine if adding lumbar neuromuscular control retraining exercises to a 12-week program of strengthening exercises had greater effect for improving disability than 12 weeks of strengthening exercises alone in people with chronic low back pain (LBP). * DESIGN: Single-center, participant- and assessor-blinded, comparative effectiveness randomized controlled trial. tMETHODS: Sixty-nine participants (31 females; 29 males; mean age: 46.5 years) with nonspecific chronic LBP were recruited for a 12-week program involving lumbar extension neuromuscular retraining in addition to resistance exercises (intervention) or 12 weeks of resistance exercises alone (control). The primary outcome measure was the Oswestry Disability Index. Secondary outcome measures included the Numeric Rating Scale, Tampa Scale for Kinesiophobia, Pain Self-Efficacy Questionnaire, and the International Physical Activity Questionnaire. Outcomes were measured at baseline, 6 weeks, and 12 weeks. * RESULTS: Forty-three participants (22 control, 21 intervention) completed all outcome measures at 6 and 12 weeks. Fourteen participants were lost to follow-up, and 12 participants discontinued due to COVID-19 restrictions. Both groups demonstrated clinically important changes in disability, pain intensity, and kinesiophobia. The difference between groups with respect to disability was imprecise and not clinically meaningful (mean difference, -4.4; 95% CI: -10.2, 1.4) at 12 weeks. Differences in secondary outcomes at 6 or 12 weeks were also small with wide confidence intervals. * CONCLUSIONS: Adding lumbar neuromuscular control retraining to a series of resistance exercises offered no additional benefit over resistance exercises alone over a 12-week period. [ABSTRACT FROM AUTHOR]

This article provides an overview of noninferiority clinical trials for clinical cardiologists. Noninferiority trials are designed to assess whether a new treatment is not worse than an established treatment by a certain degree. The article discusses the advantages and limitations of noninferiority trials, including scenarios where they might be preferred and challenges in their design and execution. Key statistical considerations, such as defining the noninferiority margin and the use of confidence intervals, are also addressed. Overall, noninferiority trials offer benefits when properly conducted and are likely to continue growing in cardiology. [Extracted from the article]

Background: High consumption of sugar-sweetened beverages (SSB) is a global health concern. Additionally, sugar-sweetened beverage (SSB) consumption is disproportionately high among adolescents and adults in rural Appalachia. The primary study objective is to determine the intervention effects of Kids SIPsmartER on students' SSB consumption. Secondary objectives focus on caregivers' SSB consumption and secondary student and caregiver outcomes [e.g, body mass index (BMI), quality of life (QOL)]. Methods: This Type 1 hybrid, cluster randomized controlled trial includes 12 Appalachian middle schools (6 randomized to Kids SIPsmartER and 6 to control). Kids SIPsmartER is a 6-month, 12 lesson, multi-level, school-based, behavior and health literacy program aimed at reducing SSB among 7th grade middle school students. The program also incorporates a two-way text message strategy for caregivers. In this primary prevention intervention, all 7th grade students and their caregivers from participating schools were eligible to participate, regardless of baseline SSB consumption. Validated instruments were used to assess SSB behaviors and QOL. Height and weight were objectively measured in students and self-reported by caregivers. Analyses included modified two-part models with time fixed effects that controlled for relevant demographics and included school cluster robust standard errors. Results: Of the 526 students and 220 caregivers, mean (SD) ages were 12.7 (0.5) and 40.6 (6.7) years, respectively. Students were 55% female. Caregivers were mostly female (95%) and White (93%); 25% had a high school education or less and 33% had an annual household income less than $50,000. Regardless of SSB intake at baseline and relative to control participants, SSB significantly decreased among students [-7.2 ounces/day (95% CI = -10.7, -3.7); p < 0.001, effect size (ES) = 0.35] and caregivers [-6.3 ounces/day (95% CI = -11.3, -1.3); p = 0.014, ES = 0.33]. Among students (42%) and caregivers (28%) who consumed > 24 SSB ounces/day at baseline (i.e., high consumers), the ES increased to 0.45 and 0.95, respectively. There were no significant effects for student or caregiver QOL indicators or objectively measured student BMI; however, caregiver self-reported BMI significantly decreased in the intervention versus control schools (p = 0.001). Conclusions: Kids SIPsmartER was effective at reducing SSB consumption among students and their caregivers in the rural, medically underserved Appalachian region. Importantly, SSB effects were even stronger among students and caregivers who were high consumers at baseline. Trial registration: Clincialtrials.gov: NCT03740113. Registered 14 November 2018– Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03740113. [ABSTRACT FROM AUTHOR]

Objective: To systematically evaluate the evidence relating to acupuncture on the sleep quality of patients with Parkinson's disease. Data sources: Six English-language (PubMed, Cochrane Library, EBSCOhost, Embase, OVID MEDLINE, and Web of Science) and four Chinese-language (China National Knowledge Infrastructure, SinoMed, China Scientific Journals Database, and Wanfang) databases were searched for pertinent studies published from database inception to 11 October 2023. Methods: Two researchers independently screened eligible studies and extracted relevant data using custom data extraction tables. Methodological quality assessment of the included studies was performed using Cochrane Handbook 5.1.0. Meta-analysis was performed using Cochrane Review Manager version 5.4. Results: Twenty-four studies (1701 participants) met inclusion criteria. The meta-analysis showed that acupuncture improved the Parkinson's Disease Sleep Scale, Pittsburgh Sleep Quality Index, Hamilton Anxiety Scale, Hamilton Depression Scale, Self-Rating Depression Scale, and Parkinson's Disease Questionnaire 39 scores compared with controls (all P < 0.05). Conclusion: This review showed that acupuncture improved sleep quality, anxiety and depressive symptoms, and quality of life of patients with Parkinson's disease relative to controls. [ABSTRACT FROM AUTHOR]

Chinese immigrant survivors of men's violence experience both significant mental health impacts from abuse and barriers to formal services. Therefore, we examined the preliminary efficacy of an innovative mobile-based empowerment-based intervention (self-compassion, health, and empowerment; SHE) that specifically focuses on abused Chinese immigrant women in the US. This pilot study used a two-arm randomized controlled design with repeated measures. A convenience sample (N = 50) of Chinese immigrant women who experienced past year intimate partner violence (IPV) were recruited online and randomly assigned to the intervention or control group (25 per group). We assessed IPV exposure, safety behaviors, depressive symptoms, anxiety symptoms, post-traumatic stress disorder (PTSD) symptoms, and self-compassion at baseline, post-intervention, and 8-week follow-up. Of 95 eligible participants, 50 (52.6%) agreed to participate and completed baseline data collection; intervention completion rate was 64%. We found a significant group and time interaction for self-judgment (a self-compassion component), with a significant reduction seen in the intervention group compared to the control group. Despite no other significant group differences observed over time, the intervention group showed consistent trends toward improvements in most outcome measures, including specific types of IPV (i.e., negotiation, psychological aggression, and sexual coercion), depressive and PTSD symptoms, self-compassion, and certain components of self-compassion (i.e., isolation and over-identification) when compared to the control group. Our findings suggest that the SHE intervention shows promise in improving the mental health well-being of Chinese immigrant survivors. However, a fully powered randomized controlled trial is warranted to determine its efficacy. Our intervention has the potential to be translated in the Chinese immigrant populations with the necessary organizational support. [ABSTRACT FROM AUTHOR]

Background: The purpose of the present study was to systematically delve into the efficacy and safety of transcutaneous electrical acupoint stimulation (TEAS) on the quality of recovery after general anesthesia. Methods: Randomized controlled trials related to TEAS improving postoperative recovery quality were searched in Cochrane Library, Web of Science, Embase, PubMed, CNKI, VIP, Wanfang and Chinese biomedical database from the inception of each database to June 2023. After literature screening and data extraction, Stata15 software was employed for meta-analysis, and the quality of the included literature was evaluated utilizing ROB2. Results: The study included 10 articles involving 2,383 patients in total. The meta-analysis results unveiled that TEAS could improve 24-hour and 48-hour postoperative QoR-40 scores as well as 24-hour postoperative QoR-40 dimension scores [WMD = 8.52, 95%CI (5.12, 11.91), P < 0.001; WMD = 1.99, 95%CI (0.91, 3.07), P < 0.001], emotional state [WMD = 1.38, 95%CI (0.66, 2.09), P < 0.001], physical comfort [WMD = 2.99, 95%CI (1.59, 4.39), P < 0.001], psychological support [WMD = 0.63, 95%CI (0.36, 0.90), P < 0.001], and physical independence [WMD = 0.76, 95%CI (0.22, 1.30), P = 0.006]; pain [WMD = 1.81, 95%CI (0.87, 2.75), P < 0.001]; decrease 24-hour postoperative VAS pain scores [WMD = -0.84, 95%CI (-1.45, -0.23), P = 0.007] and the incidence of postoperative nausea and vomiting [RR = 0.88, 95%CI (0.81, 0.97), P = 0.006; RR = 0.62, 95%CI (0.52, 0.73), P < 0.001]. Conclusion: TEAS can improve postoperative QoR-40 scores and the quality of recovery, relieve pain, and decrease the incidence of nausea and vomiting after surgery in patients who underwent general anesthesia. Trial registration: CRD42023433959. [ABSTRACT FROM AUTHOR]

Objectives To assess eligibility criteria that either explicitly or implicitly exclude older patients from randomized controlled trials (RCTs) in RA. Methods Our analysis included RCTs of pharmacological interventions registered with ClinicalTrials.gov and started between 2013 and 2022. Co-primary outcomes were proportions of trials with an upper age limit and the eligibility criteria indirectly increasing risk of the exclusion of older adults. Results A total of 143/290 (49%) trials had an upper age limit of 85 years or less. Multivariable analysis showed that the odds of an upper age limit were significantly lower in trials performed in the USA [adjusted odds ratio (aOR), 0.34; CI, 0.12–0.99; P  = 0.04] and intercontinental trials (aOR, 0.4; CI, 0.18–0.87; P  = 0.02). In total, 154/290 (53%) trials had at least one eligibility criterion implicitly excluding older adults. These included specific comorbidities (n  = 114; 39%), compliance concerns (n  = 67; 23%), and broad and vague exclusion criteria (n  = 57; 20%); however, we found no significant associations between these criteria and trial characteristics. Overall, 217 (75%) trials either explicitly or implicitly excluded older patients; we also noted a trend towards increasing proportion of these trials over time. Only one trial (0.3%) enrolled solely patients aged 65 and older. Conclusion Older adults are commonly excluded from RCTs in RA based on both age limits and other eligibility criteria. This seriously limits the evidence base for the treatment of older patients in clinical practice. Given the growing prevalence of RA in older adults, relevant RCTs should be more inclusive to them. [ABSTRACT FROM AUTHOR]

Background: The effects of acupuncture have varied in different randomized controlled trials (RCTs), and there are many factors that influence treatment effect of acupuncture in different outcomes, with conflicting results. Objective: To identify factors and their impact on the treatment effect of acupuncture in different outcomes. Methods: Acupuncture RCTs were searched from 7 databases including Medline (PubMed), Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc between January 1st, 2015 and December 31st, 2019. Eligible studies must compare acupuncture to no acupuncture, sham acupuncture, or waiting lists, and report at least 1 patient-important outcome. A multi-level meta-regression was conducted using a 3-level robust mixed model and univariate analyses were performed for all independent variables, even those excluded from the multivariable model due to collinearities. We used thresholds of 0.2 and 0.4 for the difference of standardized mean differences (SMDs), categorising them as small (<0.2), moderate (0.2–0.4), or large (>0.4) effects. Results: The pain construct analysis involved 211 effect estimates from 153 studies and 14 independent variables. High-frequency acupuncture treatment sessions produced larger effects compared to low-frequency sessions [large magnitude, the difference of adjusted SMDs 0.46, 95% confidence interval (CI) 0.07 to 0.84; P=0.02]. The non-pain symptoms construct analysis comprised 323 effect estimates from 231 studies and 15 independent variables. Penetrating acupuncture showed moderately larger effects when compared to non-penetrating acupuncture (0.30, 95% CI 0.06 to 0.53; P=0.01). The function construct analysis included 495 effect estimates from 274 studies and 14 independent variables. Penetrating acupuncture and the flexible acupuncture regimen showed moderately larger effects, compared to non-penetrating acupuncture and fixed regimen, respectively (0.40, 95% CI 0 to 0.80; P=0.05; 0.29, 95% CI 0.06 to 0.53; P=0.01). Conclusions: High-frequency acupuncture sessions appear to be a more effective approach to managing painful symptoms. Penetrating acupuncture demonstrated greater effect in relieving non-painful symptoms. Both penetrating acupuncture type and flexible acupuncture regimen were linked to significant treatment effects in function outcomes. Future studies should consider the factors that are significantly associated with the effects of acupuncture in patient-important outcomes. [ABSTRACT FROM AUTHOR]

Background Recurrent Clostridioides difficile infection (rCDI) occurs frequently, and concomitant antibiotic (CA) during the initial episode for treatment of non-CDI is a major risk factor. We sought to address the comparative efficacy of fidaxomicin versus vancomycin in the setting of CA during the initial CDI episode. Methods We conducted a randomized, controlled, open-label trial at 2 hospitals in Ann Arbor, Michigan. We consecutively consented and enrolled hospitalized patients ≥18 years old with diarrhea, a positive test for C. difficile , and ≥1 qualifying CA. Complicated CDI, CDI treatment for >24 hours prior to enrollment, and planned long-term (>12 weeks) CA use were notable exclusions. Clinical cure was defined as resolution of diarrhea for 2 consecutive days maintained until 2 days after therapy, and rCDI as recurrent diarrhea with positive testing ≤30 days after initial treatment. Patients were randomized to fidaxomicin or vancomycin. Results Baseline characteristics were similar in the 2 groups of 144 patients. Rates of clinical cure (73% vs 62.9%, P =.195) and rCDI (3.3% vs 4.0%; P >.99) were similar for fidaxomicin and vancomycin in the intention-to-treat and per-protocol cohorts, respectively. Only 4 patients developed rCDI. Conclusions In this study of patients with CDI receiving CA, a numerically higher proportion were cured with fidaxomicin versus vancomycin, but this result did not reach statistical significance. Overall recurrence was lower than anticipated in both arms compared with previous studies that did not extend duration of CDI treatment during CA. Clinical Trials Registration www.clinicaltrials.gov (NCT02692651). [ABSTRACT FROM AUTHOR]

Background: To evaluate the efficacy and safety of Keluoxin (KLX) capsules and provide validated evidence for the application of KLX in the treatment of diabetic kidney disease (DKD). Methods: A multicenter, randomized, double-blind, placebo-controlled trial design was used to screen 129 patients with DKD (urinary albumin-to-creatinine ratio [UACR]: male, 2.5–30 mg/mmol; female, 3.5–30 mg/mmol) and with Qi and Yin deficiency and blood stasis symptoms. Written informed consent was obtained from all patients. The patients were randomly divided into KLX and control groups. The KLX group was orally administered KLX (6 g/day) and irbesartan tablets (150 mg/day), whereas the control group was administered KLX placebo (6 g/day) and irbesartan tablets (150 mg/day). Patients were observed for 24 weeks to evaluate the natural logarithm of the UACR (log-UACR), the odds ratio (OR) for a sustained increase in the UACR of at least 30% and 40%, estimated glomerular filtration rate (eGFR), changes in symptoms and quality–of-life scores, and adverse events. Results: The changes of the natural log-UACR during the 24 weeks compared with baseline in the KLX group were better than those in the control group (LS mean ± standard error, −0.26 ± 0.10 vs. 0.01 ± 0.09, p = 0.0292). The incidence of a sustained increase in the UACR of at least 30% and 40% was found to be significantly lower in the KLX group (OR, 0.26; 95% confidence interval [CI], 0.09–0.75; OR, 0.29; 95% CI, 0.10–0.82). Changes in symptoms and quality-of-life scores in the KLX group were better than those in the control group. There was no statistically significant difference in eGFR or the incidence of adverse events between the groups. Conclusions: Overall, these results suggest that KLX capsules combined with irbesartan can reduce microalbuminuria, relieve the symptoms, and improve the quality of life for patients with type 2 early DKD compared with the use of irbesartan alone. Trial registration: Chinese Clinical Trial Registry, registration number: ChiCTR2100052764. [ABSTRACT FROM AUTHOR]

Objectives: The aims of the study are to systematically evaluate the effect of body weight support training on lower extremity motor function(s) in patients with spinal cord injury and to compare the effect differences among three body weight support training methods. Design: PubMed, Web of Science, Cochrane Library, Embase, CNKI, CBM, China Scientific Journal, and Wan Fang databases were searched until December 31, 2022. Meta-analysis and network meta-analysis were conducted using RevMan 5.4 and ADDIS 1.16.8. Results: Nineteen randomized controlled trials involving 864 patients were included. The meta-analysis showed that body weight support training could improve lower extremity motor scores according to the International Standards for Neurological Classification of Spinal Cord Injury standard (mean difference = 6.38, 95% confidence interval = 3.96–8.80, P < 0.05), walking speed (standard mean difference = 0.77, 95% confidence interval = 0.52–1.02, P < 0.05), and modified Barthel Index scores (mean difference = 9.85, 95% confidence interval = 8.39–11.30, P < 0.05). The network meta-analysis showed no significant difference among the three body weight support training methods for improving lower extremity motor scores in patients with spinal cord injury. The best probability ranking of the body weight support training methods for improving lower extremity motor scores in patients with spinal cord injury was robot-assisted gait training (P = 0.60), followed by aquatic exercise (P = 0.21) and body weight support training (P = 0.19). Conclusions: Body weight support training can improve lower extremity motor score in patients with spinal cord injury. No significant difference was observed among the three body weight support training methods, but robot-assisted gait training may produce the best effect. [ABSTRACT FROM AUTHOR]

Introduction: Developing alternative approaches to evaluating absolute efficacy of new HIV prevention interventions is a priority, as active-controlled designs, whereby individuals without HIV are randomized to the experimental intervention or an active control known to be effective, are increasing. With this design, however, the efficacy of the experimental intervention to prevent HIV acquisition relative to placebo cannot be evaluated directly. Methods: One proposed approach to estimate absolute prevention efficacy is to use an HIV exposure marker, such as incident rectal gonorrhea, to infer counterfactual placebo HIV incidence. We formalize a statistical framework for this approach, specify working regression and likelihood-based estimation approaches, lay out three assumptions under which valid inference can be achieved, evaluate finite-sample performance, and illustrate the approach using a recent active-controlled HIV prevention trial. Results: We find that in finite samples and under correctly specified assumptions accurate and precise estimates of counterfactual placebo incidence and prevention efficacy are produced. Based on data from the DISCOVER trial in men and transgender women who have sex with men, and assuming correctly specified assumptions, the estimated prevention efficacy for tenofovir alafenamide plus emtricitabine is 98.1% (95% confidence interval: 96.4%–99.4%) using the working model approach and 98.1% (95% confidence interval: 96.4%–99.7%) using the likelihood-based approach. Conclusion: Careful assessment of the underlying assumptions, study of their violation, evaluation of the approach in trials with placebo arms, and advancement of improved exposure markers are needed before the HIV exposure marker approach can be relied upon in practice. [ABSTRACT FROM AUTHOR]

Purpose: In a sample of healthy adolescents, the authors aimed to investigate the effects of high-intensity interval exercise (HIIE) training and detraining on baroreflex sensitivity (BRS) and it's vascular and autonomic components at rest. Methods: Nineteen volunteers were randomly allocated to (1) 4 weeks HIIE training performed 3 times per week or (2) a control condition with no intervention for the same duration as HIIE training. PRE, POST, and following 2 weeks of detraining resting supine heart rate and blood pressure were measured, and a cross-spectral method (integrated gain [gain in low frequency]) was used to determine BRS gain. Arterial compliance (AC) was assessed as the BRS vascular component. LFgain divided by AC (LFgain/AC) was used as the autonomic determinant of BRS. Results: The HIIE training was completed with 100% compliance. HIIE did not change resting gain in low frequency (LFgain) (P =.66; effect size = 0.21), AC (P =.44; effect size = 0.36), or LFgain/AC (P =.68; effect size = 0.19) compared to control. Conclusion: Four weeks of HIIE training does not change BRS and its autonomic and vascular determinant in a sample of healthy adolescents at rest. [ABSTRACT FROM AUTHOR]

Background: Although previous studies have showed that epidural morphine can be used as a complement to local anesthetics for analgesia after postcesarean delivery under spinal anesthesia, there is little known about the analgesic dosage of epidural morphine and hydromorphone for hemorrhoidectomy. Therefore, we conducted this study to examine the potency ratio of hydromorphone to epidural morphine as well as effective analgesic dose for 50% patients (ED50) undergoing elective hemorrhoidectomy. Methods: 80 patients under elective hemorrhoidectomy with combined spinal and epidural anesthesia(CSEA) in department of anesthesia, Dongguan Tungwah hospital. To assess the ED50, patients were treated with epidural morphine or epidural hydromorphone randomly using a biased coin method-determined dose with a sequential allocation procedure. Following surgery, standardized multimodal analgesia was administered to all patients. A pain response score of ≤ 3 (on a scale of 0–10) was determined to be the effective dose after 24 h following CSEA. The ED50 in both groups were determined using the probit regression and isotonic regression method. We also measured pain intensity by patient interview using a 10 point verbal numeric rating scale prospectively at 6, 12 and 24 h after CSEA, and adverse effects were also noted. Results: The ED50 was 0.350 mg (95% CI, 0.259–0.376 mg) in hydromorphone group and 1.129 mg (95% CI, 0.903–1.187 mg) in morphine group, respectively, estimated by isotonic regression method. Regression analysis with the probit, the ED50 of epidural hydromorphone was 0.366 mg (95% CI, 0.276–0.388 mg) and epidural morphine was 1.138 mg (95% CI, 0.910–1.201 mg). Exploratory findings showed that there was no difference between the most frequent dosages of epidural hydromorphone or epidural morphine in the occurrence of nausea, vomiting and pruritus. When administered with epidural opioids at ED50 doses or higher, 97.5% (39/40) of epidural morphine patients and 97.5% (39/40) epidural hydromorphone of patients were satisfied with their analgesia. Conclusion: Effective hemorrhoidectomy analgesia requires a 3:1 ratio of epidural morphine to epidural hydromorphone. Both drugs provide excellent patient satisfaction. [ABSTRACT FROM AUTHOR]

Background: Central obesity is considered as a significant health threat to individuals. Scientific research has demonstrated that intra-abdominal fat accumulation is associated with higher metabolic and cardiovascular disease risks independent of Body Mass Index (BMI). This study aimed to evaluate the efficacy and safety of electro-acupuncture in treating central obesity compared with sham acupuncture. Method: This was a patient-assessor blinded, randomized, sham-controlled clinical trial. One hundred sixty eight participants aged between 18 and 65 years old with BMI ≥ 25 kg/m2 and waist circumference (WC) of men ≥ 90 cm / women ≥ 80 cm were enrolled and allocated to the acupuncture or sham acupuncture group equally. For the acupuncture group, disposable acupuncture needles were inserted into eight body acupoints, including Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12), Zusanli (ST-36), Fenglong (ST-40), and Sanyinjiao (SP-6) with electrical stimulation. For the control group, Streitberger's non-invasive acupuncture needles were utilized at the same acupoints with identical stimulation modalities. The treatment duration was 8 weeks with 2 sessions per week and the follow-up period was 8 weeks. The primary outcome was the change in WC before and after the treatment. The secondary outcomes were the changes in hip circumference, waist-to-hip circumference ratio, BMI, and body fat percentage during the treatment and follow-up period. Results: The acupuncture group displayed a significant change in WC compared to the sham group both treatment and follow-up period (MD = -1.1 cm, 95% CI = -2.8 to 4.1). Significant change in body fat percentage was recorded for both groups after treatment but no significance was observed during the follow-up period (MD = -0.1%, 95% CI = -1.9 to 2.2). The changes in hip circumference were also significant both treatment and follow-up period for the acupuncture group (MD = -2.0 cm, 95% CI = -3.7 to -1.7). Compared with sham acupuncture, the body weight (MD = -1 kg, 95% CI = -3.3 to 5.3), BMI (MD = -0.5, 95% CI = -0.7 to 1.9) also decreased significantly within and between groups. The incidence of adverse events was similar in the two groups. Conclusion: This study provided evidence that electro-acupuncture could be effective in treating central obesity by reducing WC, hip circumference, body weight, BMI, and waist-to-hip circumference ratio. Trial registration: ClinicalTrials.gov Identifier: NCT03815253, Registered 24 Jan 2019. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to evaluate the efficacy of vestibular rehabilitation in vestibular neuritis. Design: A randomized controlled trial was collected from MEDLINE, Embase, Cochrane Library, PEDro, LILACS, and Google Scholar before May 2023. Results: This study included 12 randomized controlled trials involving 536 patients with vestibular neuritis. Vestibular rehabilitation was comparable with steroids in dizziness handicap inventory score at the first, sixth, and 12th months (pooled mean differences: −4.00, −0.21, and −0.31, respectively); caloric lateralization at the third, sixth, and 12th months (pooled mean difference: 1.10, 4.76, and −0.31, respectively); and abnormal numbers of vestibular-evoked myogenic potentials at the first, sixth, and 12th months. Patients receiving a combination of rehabilitation and steroid exhibited significant improvement in dizziness handicap inventory score at the first, third, and 12th months (mean difference: −14.86, pooled mean difference: −4.63, mean difference: −9.50, respectively); caloric lateralization at the first and third months (pooled mean difference: −10.28, pooled mean difference: −8.12, respectively); and numbers of vestibular-evoked myogenic potentials at the first and third months (risk ratios: 0.66 and 0.60, respectively) than did those receiving steroids alone. Conclusions: Vestibular rehabilitation is recommended for patients with vestibular neuritis. A combination of vestibular rehabilitation and steroids is more effective than steroids alone in the treatment of patients with vestibular neuritis. [ABSTRACT FROM AUTHOR]

The efficiency of partial body weight-supported treadmill training (PBWSTT) for treating various conditions in children and adolescents with cerebral palsy (CP) in diverse contexts of rehabilitation, households, or schools is unknown. The major objective of this systematic review and meta-analysis was to analyze the effectiveness of PBWSTT on various outcomes in different contexts among children and adolescents with CP. We incorporated full-text, randomized controlled trial studies that specifically assessed the effects of PBWSTT walking, motor function, stride, balance, and endurance in children and adolescents aged 3 to 18 years with CP. The literature search was carried out using Google Scholar, PubMed, Web of Science, CINAHL Plus, Scopus, PEDro, and ResearchGate databases. The methodological quality was evaluated using a Cochrane risk of bias instrument. A meta-analysis of pooled data from 10 studies with 255 participants demonstrated that PBWSTT for 4–12 weeks in rehabilitation (mean difference [MD] = 1.94, 95% confidence interval [CI] = 1.40—2.48, p < 0.0001), at home or in a school context (MD = 13.5, 95% CI = 13.9—16.0, p < 0.0001), was significantly effective for treating various conditions in children and adolescents suffering with CP. The period of 4–12 weeks of PBWSTT in rehabilitation and at-home/school settings is effective on various outcomes in children or adolescents with CP. [ABSTRACT FROM AUTHOR]

Background Recent studies suggest that early tumor shrinkage (ETS) and depth of response (DpR) reflect outcomes of chemotherapy in various cancers. This study evaluated the association of ETS and DpR with clinical outcomes using data from JCOG1113, which demonstrated the non-inferiority of gemcitabine plus S-1 (GS) to gemcitabine plus cisplatin (GC) for chemotherapy-naïve advanced biliary tract cancer. Material and Methods In total, 354 (289 with measurable target lesions) patients enrolled in JCOG1113 were divided into ETS-unachieved and ETS-achieved groups (≥20% tumor reduction at week 6) and DpR-low and DpR-high groups (≥40% maximum shrinkage) until 12 weeks after enrollment. The impact of ETS and DpR on survival outcome was evaluated using the multivariable Cox proportional hazard model. Results The proportions of patients in the ETS-achieved and DpR-high groups were similar between the 2 treatment arms. The hazard ratios (HRs) of progression-free survival (PFS) and overall survival (OS) for the ETS-achieved group were 0.70 (95% confidence interval (CI), 0.52-0.93) and 0.60 (95%CI, 0.44-0.81), respectively. The HRs of PFS and OS for the DpR-high group were 0.67 (95%CI, 0.48-0.94) and 0.64 (95%CI, 0.46-0.90), respectively. In the subpopulation treatment effect pattern plot analysis, most patients in the ETS-achieved group in the GC arm did not experience disease progression after 12 weeks from the landmark. Conclusion As on-treatment markers, ETS and DpR were effective tools. ETS was clinically useful, because it can be used to evaluate the outcomes of treatment early at a specific time. [ABSTRACT FROM AUTHOR]

Aim of the study: To evaluate the clinical efficacy and safety of commonly used oral Chinese patent medicines for the treatment of coronary heart disease combined with hyperlipidemia in clinical practice through a network meta-analysis. Materials and methods: PubMed, Embase, Cochrane Library, Web of Science, Wanfang, VIP, SinoMed, and CNKI databases were searched for all published randomized controlled trials (RCTs) on the treatment of coronary heart disease combined with hyperlipidemia using Chinese patent medicines. NoteExpress software was used to screen the literature obtained from the databases according to the inclusion and exclusion criteria. The Cochrane risk of bias assessment tool was used to evaluate the quality of the included studies. A network meta-analysis was performed using R 4.2.1. Subgroup analyses of outcome indicators were made based on conventional treatment (CT) methods. The incidence of adverse events in the included RCTs was statistically analyzed. A funnel plot was drawn using RevMan 5.4.1 software for the assessment of bias in the total clinical effectiveness rate. Finally, the quality of evidence for interventions with statistically significant differences was evaluated using the GRADE system. Results: A total of 78 RCTs were included, involving 7,955 cases and 8 types of Chinese patent medicines, which were Tongxinluo Capsule, Naoxintong Capsule, Compound Danshen Dripping Pill, Shexiangbaoxin Pill, Songling Xuemaikang Capsule, Xuezhikang Capsule, Yindan Xinnaotong Capsule, and Zhibitai Capsule. A total of 24 RCTs reported the incidence of adverse events, but no statistically significant difference in the incidence of adverse events was found between the experimental and control groups in each study (P > 0.05). There was no obvious publication bias in all studies, but the overall quality of evidence in the included RCTs was low. Comparison of different intervention measures showed that Naoxintong Capsule + CT improved the cardiac index and cardiac output, and lowered the low-density lipoprotein cholesterol and total cholesterol levels. Tongxinluo Capsule + CT raised high-density lipoprotein cholesterol levels and reduced triglyceride levels. Xuezhikang Capsule + CT improved the total clinical effectiveness rate. Subgroup analyses showed that differences in CT did not cause heterogeneity in the results. Conclusion: Compared with the use of CT alone, the combined use of Chinese patent medicines with CT can effectively improve the symptoms in patients with both coronary heart disease and hyperlipidemia. [ABSTRACT FROM AUTHOR]