Search

Context: The long duration and high cost of anterior cruciate ligament reconstruction (ACLR) rehabilitation can pose barriers to completing rehabilitation, the latter stages of which progress to demanding sport-specific exercises critical for a safe return to sport. A staged approach shifting in-person physiotherapy sessions to later months of recovery may ensure patients undergo the sport-specific portion of ACLR rehabilitation. Design/Objective: To compare postoperative outcomes of knee function in patients participating in a staged ACLR physiotherapy program to patients participating in usual care physiotherapy through a randomized controlled trial. Methods: One hundred sixty-two patients were randomized to participate in staged (n = 80) or usual care physiotherapy (n = 82) following ACLR and assessed preoperatively and postoperatively at 2 weeks, 6 weeks, 3 months, and 6 months. The staged group completed the ACLR rehabilitation protocol at home for the first 3 months, followed by usual care in- person sessions. The usual care group completed in-person sessions for their entire rehabilitation. Outcome measures included the Lower Extremity Functional Scale, International Knee Documentation Committee Questionnaire, pain, range of motion, strength, and hop testing. Results: There were no statistically significant between-group differences in measures of knee function at 6 months postoperative. Patients in the usual care group reported significantly higher International Knee Documentation Committee scores at 3 months postoperative (mean difference = 5.8; 95% confidence interval, 1.3 to 10.4; P = .01). Conclusion: A staged approach to ACLR rehabilitation does not appear to impede knee function at 6 months postoperative but may result in worse patient reported outcomes at early follow-ups. [ABSTRACT FROM AUTHOR]

Objective: The present study aimed to evaluate the local effect of antimicrobial photodynamic therapy (aPDT) as adjunctive treatment for Grade C periodontitis in molars teeth. Method and materials: Thirty-eight molar teeth from 11 patients were included in this split-mouth randomized clinical trial. The teeth were randomly divided into two groups (n = 19 each) that were submitted to conventional scaling and root planing in addition to aPDT (test group) and to scaling and root planing in addition to aPDT simulation (control group). The following periodontal parameters were obtained prior to treatment (baseline) and at 3 months after the intervention: bleeding on probing, probing depth, gingival recession, clinical attachment level, and furcation level. A 5% significance level was adopted in the statistical analysis. Results: Both groups exhibited improvement in the clinical parameters (P < .001). However, the reductions in bleeding on probing and probing depth were greater in the test group (P < .001). There were no significant differences in the other clinical parameters between groups (P ≥ .130). Conclusions: Molar teeth treated with aPDT and scaling and root planing showed superior clinical improvement compared to those submitted only to scaling and root planing. aPDT may be used as adjunctive treatment for Grade C periodontitis affecting molar teeth since it seems to improve the clinical response to conventional debridement. [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]

Background: In an Australian randomized controlled trial (RCT), two techniques for intrapartum fetal surveillance were compared: ST analysis (STan) as an adjunct to cardiotocography (CTG), compared with CTG alone. The aim was to determine whether CTG + STan could reduce emergency cesarean birth rates while maintaining or improving neonatal outcomes. Secondary aims were to compare clinical, economic, and psychosocial outcomes. The purpose of this paper was to present psychosocial outcomes from one cohort enrolled in the trial. Methods: The study was conducted at one tertiary referral hospital. Participants who had taken part in the trial from the outset were invited to complete a questionnaire between March 2018 and January 2020, approximately 8 weeks after giving birth. Outcomes included depression, psychological distress, health‐related quality of life, and infant feeding practices. Analysis was by intention to treat. Results: N = 207/527 participants completed the questionnaire (n = 113, STan; n = 94, CTG alone). Overall, no statistically significant or clinically meaningful differences were found in the two groups for symptoms of depression, psychological distress, quality of life, or infant feeding. A statistically significant difference was observed for the subscale of pain‐discomfort, where scores were higher on average in the CTG alone arm relative to that in the CTG + STan arm. Conclusions: Although STan as an adjunct to CTG constitutes a different clinical technology from CTG alone, both monitoring types appeared to produce similar results in terms of postnatal psychosocial outcomes for women. Findings from this study provide service users and staff with a comprehensive assessment of STan that can be used to make evidence‐informed decisions about monitoring options should STan become more widely available. [ABSTRACT FROM AUTHOR]

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

Background and Hypothesis Based on a childhood intervention from ages 3 to 5 years that included additional fish consumption and which resulted in reduced schizotypal personality at age 23, we had previously hypothesized that omega-3 could reduce schizotypy. The current study tests the hypothesis that omega-3 supplementation reduces schizotypy in children. Study Design In this intention-to-treat, randomized, single-blind, stratified, factorial trial, a community sample of 290 children aged 11–12 years were randomized into Omega-3 Only, Cognitive Behavioral Therapy (CBT) Only, Omega-3 + CBT, and Control groups. Schizotypy was assessed using the SPQ-C (Schizotypal Personality Questionnaire for Children) at 0 months (baseline), 3 months (end of treatment), 6 months (3 months post-treatment), and 12 months (9 months post-treatment). Study Results A significant group × time interaction (P  = .013) indicated that, compared with Controls, total schizotypy scores were reduced in both Omega-3 Only and Omega-3 + CBT groups immediately post-treatment (d  = 0.56 and 0.47, respectively), and also 3 months after supplementation terminated (d  = 0.49, d  = 0.70). Stronger findings were observed for the interpersonal schizotypy factor, with both omega-3 groups showing reductions 9 months post-treatment compared with the CBT Only group. Schizotypy reductions were significantly stronger for those with higher dietary intake of omega-3 at intake. Sensitivity analyses confirmed findings. Conclusions Results are unique in the field and suggest that omega-3 can help reduce schizotypal personality in community-residing children. From an epidemiological standpoint, if replicated and extended, these findings could have implications for early prevention of more significant schizotypal features developing later in adolescence. Clinical Trial Registration "Healthy Brains & Behavior: Understanding and Treating Youth Aggression (HBB)." ClinicalTrials.gov Identifier: NCT00842439 , https://clinicaltrials.gov/ct2/show/NCT00842439. [ABSTRACT FROM AUTHOR]

Background: The current clinical management of carotid atherosclerosis is based on the control of risk factors and medicine. However, the risk of adverse events associated with the medicine resulting in concerns and low medication compliance makes it necessary to seek a safer alternative therapy. This study assessed the effectiveness and safety of acupuncture as a treatment for carotid atherosclerosis. Methods: In this randomized controlled trial, patients with carotid atherosclerotic plaques were included and randomly assigned (1:1) to receive real acupuncture or sham acupuncture for 12 weeks. The follow-up period was 12 weeks. The primary outcome included carotid intima-media thickness (cIMT), plaque score (PS), plaque volume (PV) and grey-scale median (GSM). Secondary outcome was pulse wave velocity (PWV). Adverse events results were recorded as safety outcomes. Results: From January 2021 to February 2022, 60 eligible patients were included. 55 patients (91.7%) completed the intervention and the 12-week follow-up and there was no statistical difference in demographics between the groups. At the end of treatment, the real acupuncture group had significantly reduced PS (P = 0.002), PV (P = 0.000), and improved GSM (P = 0.044). There was no significant difference in the reduction in cIMT (Left cIMT: P = 0.338, Right cIMT: P = 0.204) and PWV between the groups (the left BS: P = 0.429; the left ES: P = 0.701; the right BS: P = 0.211; the right ES: P = 0.083). Three mild adverse reactions occurred during the study. Conclusion: This study found that acupuncture had a certain effect on reducing the thickness and volume of carotid plaque and improving the stability of plaque with minor side effects. These findings suggest that acupuncture may be a potential alternative therapy for carotid atherosclerosis. Trial registration: This trial has been registered at ClinicalTrials.gov (ChiCTR2100041762). Submitted 30 December 2020, Registered 4 January 2021 Prospectively registered. [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: Heart failure (HF) is a debilitating disease with worsening symptoms and family caregiving burden. HF affects more than 8 million Americans. West Virginia has the highest HF death rate in the U.S. and limited healthcare services. This study tested whether the family HF palliative and end-of-life care intervention (FamPALcare) improved patient and caregiver outcomes at 3- and 6-month study endpoints. Methods: This study used a randomized controlled trial design. Patients with HF and their caregivers were randomly assigned together to the intervention (n = 21) or control (n = 18) group. The intervention included five telephone coaching sessions on the HF home, palliative, and end-of-life care. The outcome data collected at baseline and at 3 and 6 months were from the patients' (a) HF-related health status and depression/anxiety scale scores; and from caregivers' (b) caregiving burden and depression/anxiety scale scores; and (c) anonymous ratings on the 11-item FamPALcare helpfulness scale, completed by the intervention participants. Results: The mean age of the patients was 65.66 (SD = 13.72) years, and 67% were White males. The mean age of the caregivers was 62.05 (SD = 13.14) years, and 77% were White females. Compared to the controls, patients in the intervention group had significantly greater scores for HF-related health status (p <.05) and lower depression/anxiety scores at 6 months, the study endpoint. The family caregivers in the intervention group had significantly lower scores on caregiving burden (p <.05) and depression/anxiety (p <.01) at 3 months. The mean helpfulness rating was M = 4.46 out of 5 (SD = 0.49). Conclusions: The FamPALcare intervention was found to be effective at improving patient HF-related health status and reducing caregiver burden and improving both patient and caregiver depression and anxiety scores. The FamPALcare HF intervention was found feasible and consistently delivered (fidelity). The FamPALcare intervention's cost-effectiveness and helpfulness ratings information will be used to plan for subsequent clinical trials. Trial registration: ClinicalTrials.gov NCT04153890, Registered on 4 November 2019, https://clinicaltrials.gov/ct2/show/NCT04153890. [ABSTRACT FROM AUTHOR]

Background 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: Nutritional strategies to maintain bone health in aging individuals are of great interest. Given the beneficial nutrient composition of walnuts, rich in alpha‐linolenic (the vegetable n‐3 fatty acid) and polyphenols, their regular consumption might be a dietary option to reduce age‐related bone loss. We determined whether daily walnut consumption improves bone mineral density (BMD) and circulating biomarkers of bone turnover. Methods: The Walnuts and Healthy Aging study (WAHA) is a two‐center, parallel, randomized controlled trial evaluating the effect of a diet enriched with walnuts at ≈15% energy compared with a control diet for 2 years on age‐related health outcomes in healthy men and women aged 63–79 years. Changes in BMD were a prespecified secondary outcome only at the Barcelona node of the trial, where 352 participants were randomized. Retention rate was 92.6%. Primary endpoints were 2‐year changes in BMD at the spine and the nondominant femoral neck, determined by dual‐energy X‐ray absorptiometry (DXA). Secondary endpoints were 2‐year changes in bone turnover biomarkers (adrenocorticotropic hormone, Dickkopf WNT signaling pathway inhibitor‐1, osteoprotegerin, osteocalcin, osteopontin, sclerostin, parathyroid hormone, and fibroblast growth factor‐23), which were quantified in 211 randomly selected participants. Results: The walnut diet versus the control diet had no effect on 2‐year changes in BMD at the spine (0.15% vs. 0.35%, p = 0.632) and femoral neck (−0.90% vs. −0.70%, p = 0.653), or on bone turnover biomarkers. Results were similar in participants treated or not with bone resorption inhibitors or those with or without osteoporosis/osteopenia at inclusion. Conclusions: Compared with the usual diet, a diet enriched with walnuts at 15% of energy for 2 years failed to improve BMD or circulating markers of bone metabolism in healthy older people. [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]

Despite sedentary behavior being ubiquitous in students and detrimental to health, interventions specifically targeting it are mostly restricted to leisure time screen time reduction. With six weekly sessions alongside a poster campaign and an additional teacher intervention, the Let's Move It trial delivered environmental and psychological strategies to increase physical activity (PA) and reduce sedentary behavior (SB) in vocational schools, an understudied environment for behavioral interventions. Participants in the intervention arm considerably reduced sedentary time post-intervention. To investigate how social cognitions about restricting SB, as defined by the Reasoned Action Approach, change in intervention and control arms, self-reported data on social cognitions was collected as part of a cluster-randomized controlled trial from 1166 students (59% female, mage = 18.7 years, range: 16–49) in six vocational schools before, post-intervention, and 14 months post-baseline. Data were analyzed using mixed between-within repeated measures ANOVA. We found greater improvements in intention (F(1, 833) = 9.69; η2p = 0.01; p =.018) and descriptive norms (F(1, 831) = 13.25; η2p = 0.016; p <.001) in the intervention than control arm, but these effects depended on the included control variables. Generally, intervention effects leveled off from post-intervention to follow-up. The Let's Move It intervention for SB reduction showed modest, short-lived effects on social cognitions, indicating that changes in behavior are likely due to other factors like changes to the classroom environment. Optimally, SB reduction interventions should not only change behavior but produce robust changes in conscious intentions to restrict one's sitting, so that positive effects generalize to other contexts. [ABSTRACT FROM AUTHOR]

Objective: Theoretical models highlight body image disturbances as central to the maintenance of eating disorders, with empirical evidence finding negative body image to be a robust predictor of treatment nonresponse, relapse and symptom persistence. Accessible, scalable, and inexpensive interventions that can effectively target negative body image across the eating disorders are needed. We developed an online single session intervention (SSI) for negative body image and evaluated its acceptability and efficacy in a randomized controlled trial in individuals with recurrent binge eating. Method: Participants with recurrent binge eating were randomly assigned to the SSI (n = 99) or a waitlist (n = 101). Assessments were conducted at baseline, 4 week follow‐up, and 8 week follow‐up. Results: 81% of participants accessed the SSI, demonstrating reasonable uptake. However, issues with attrition were apparent; a 32% study dropout rate was observed at posttest, while a 58% dropout rate was observed at follow‐up. 87% of participants who completed satisfaction measures would recommend the SSI. SSI participants experienced greater improvements in negative body image at both 4 (d = −0.65) and 8 week (d = −0.74) follow‐up. Significant between‐group effects were also observed on most other secondary symptom measures, though no differences were found for motivations and help‐seeking beliefs and intentions. Conclusion: Body image‐focused self‐guided SSIs for recurrent binge are largely accepted by those who are retained in the trial, but are associated with significant attrition. Although SSIs are not intended to replace standard treatment, they may help with short‐term symptom management and could play an important role in eating disorder care. Public Significance: Single session interventions (SSI) are a potentially accessible, scalable, and cost‐effective way to deliver evidence‐based treatment content to people with eating disorders. This study shows that an online (SSI) designed to target body image among people with recurrent binge eating is accepted and produced short‐term symptom relief. [ABSTRACT FROM AUTHOR]

Purpose: The manifestation of behavioral and psychological symptoms of dementia (BPSD) poses a considerable care burden and precipitates adverse health outcomes. Despite the increasing development of digital interventions, their application in the dementia population, specifically regarding their effectiveness in addressing BPSD, remains limited. Therefore, in this study, we aimed to describe a study protocol for evaluating the effectiveness of a mobile app-based individualized non-pharmacological intervention to improve BPSD in community-dwelling older adults. Methods: Employing a randomized control group pretest-posttest design, 36 dyads comprising people living with dementia (PLWD) and their family caregivers will be assigned to either an experimental or control group. The experimental group will engage in a 4-week regimen using a mobile app-based individualized non-pharmacological intervention, which includes recording and predicting BPSD. The control group will use the BPSD record system without accessing the individualized interventions. Both groups will continue with their usual care practices throughout the study period. Results: We hypothesize that the implementation of the mobile app-based individualized non-pharmacological intervention will alleviate BPSD. After the intervention, results will be analyzed to evaluate the effectiveness of the mobile app-based individualized non-pharmacological intervention on BPSD. Conclusion: The research team may encounter several challenges owing to the novelty of digitalized interventions. Nevertheless, the results of this study will provide robust evidence regarding the efficacy of mobile app-based individualized non-pharmacological interventions for community-dwelling older PLWD. [ABSTRACT FROM AUTHOR]

Objectives: This study was conducted in order to determine the effect on halitosis and the antibacterial effect against halitosis‐causing bacteria of the mouthwash made of the natural material, Glycyrrhiza uralensis (G. uralensis) extract. Materials and Methods: A randomized, double‐blind, placebo‐controlled study was conducted on 60 patients who visited M dental clinic located in Busan, South Korea, excluding those with systemic disease that may induce halitosis. There were 30 patients classified to the saline gargle group and the remaining 30 patients were classified to the G. uralensis extract gargle group. In addition, their level of halitosis and halitosis‐causing bacteria were measured. They visited the dental clinic on a fasted state at baseline before gargle application (Baseline), immediately after gargle application (Treatment) and 5 days after gargle application (After 5 Days). For clinical indicators, participants were tested for halitosis and bacteria immediately after waking up without brushing their teeth and without hydration. Results: The prevalence of halitosis decreased in the G. uralensis extract gargle group compared to the saline gargle group at Treatment and After 5 Days. In cases with pseudo halitosis, there was a significant decrease in halitosis‐causing bacteria when G. uralensis extract gargle was applied (p < 0.05). Conclusions: It was identified that using a mouthwash made with G. uralensis extract is effective for halitosis improvement and reduction of halitosis‐causing bacteria. Therefore, using a mouthwash containing G. uralensis extract, it will be effective in improving bad breath and oral hygiene will be possible. [ABSTRACT FROM AUTHOR]

Background: Early childhood educators play a critical role in promoting physical activity and reducing sedentary time in childcare centres. However, early childhood educators receive limited specialised pre- and in-service learning opportunities relating to these behaviours and may lack the capacity to effectively engage children in healthy movement behaviours. This study aimed to examine the efficacy of an e-Learning course on increasing early childhood educators' physical activity and sedentary behaviour-related capacities. Methods: A two-group parallel randomized controlled trial was conducted with early childhood educators in Canada (Mage = 41.78, 97% female). Participants randomized to the intervention group were asked to complete a physical activity and sedentary behaviour e-Learning course within a 4-week period. Participants randomized to the waitlist control condition were assigned to a waitlist to receive the intervention after the testing period. Participants reported on their self-efficacy, knowledge, intentions, and perceived behavioural control relating to physical activity and sedentary behaviours at baseline, post-intervention, and 3 months follow-up. Linear mixed effects models were estimated to determine difference in changes in outcomes from baseline to post-intervention, and follow-up. Results: A total of 209 early childhood educators participated in the study (intervention n = 98; control n = 111). The TEACH e-Learning course was found to be efficacious at improving all of the examined outcomes, with standardized effect sizes ranging from d = 0.58 to d = 0.65 for self-efficacy outcomes, d = 0.66 to d = 1.20 for knowledge outcomes, d = 0.50 to d = 0.65 for intention outcomes, and d = 0.33 to d = 0.69 for perceived behavioural control outcomes post-intervention. The intervention effects were sustained at follow-up for all outcomes apart from perceived behavioural control to limit screen time. Additionally, the magnitude of the effect for knowledge outcomes decreased at follow-up, with standardized effect sizes ranging from d = 0.49 to d = 0.67. Conclusions: The e-Learning course was highly successful at improving early childhood educators' capacity pertaining to physical activity and sedentary behaviours. Providing training content through e-Learning may be an efficacious approach to providing continual professional learning opportunities relating to physical activity and sedentary time to early childhood educators on a large scale. [ABSTRACT FROM AUTHOR]

Background: This study investigated the optimal concentration of ropivacaine epidural anesthesia for clinical use in percutaneous transforaminal endoscopic discectomy (PTED) by comparing the effects of different concentrations. Methods: Seventy patients scheduled for their first PTED procedure were enrolled in this randomized controlled trial. Patients were randomized to receive ropivacaine at varying concentrations (0.3% or 0.4%). Primary outcome measures included the numeric rating scale (NRS) and hip extension level (HEL). Secondary outcome measures included intraoperative fentanyl dosage and postoperative complications. Results: One patient withdrew due to severe postoperative complications. The remaining 69 patients were allocated to the 0.3% (n = 34) and 0.4% (n = 35) groups, respectively. Baseline characteristics showed no significant differences between the two groups (P > 0.05). The NRS score was significantly lower in the 0.4% group than in the 0.3% group (P < 0.01), whereas the HEL score was significantly higher (P < 0.001). The average fentanyl dose in the 0.4% group was significantly lower than that in the 0.3% group (P < 0.01). Postoperative complications occurred in five and two patients in the 0.3% and 0.4% groups, respectively. Conclusion: Although 0.4% ropivacaine (20 mL) impacts muscle strength, it does not impede PTED surgery. Given its effective analgesic properties and few postoperative complications, 0.4% ropivacaine can be considered a preferred dose for PTED. Trial registration: This study was registered with the Chinese Clinical Trials Registry (Registration number: ChiCTR2200060364; Registration Date: 29/5/2022) and on chictr.org.cn (https://www.chictr.org.cn/showproj.html?proj=171002). [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]

This randomized controlled trial examined the effects of fictive kin interaction on the physical health and psychological well-being of older adults living in a shared site nursing home in China. The results revealed that depression levels significantly decreased and self-efficacy and flourishing levels significantly increased among the participants who engaged in additional one-to-one pair activities with kindergartners, with the effect size ranging from medium to large. The research findings indicated that one-to-one fictive kinship interactions between older adults and young children can promote the self-perceived physical health and psychological well-being of older adults in a Chinese context. [ABSTRACT FROM AUTHOR]

Background The popularity of temporary abstinence challenges (TACs) concerning alcohol consumption is increasing. Support is found to be essential for participants to help them get through a challenge. This study aimed to evaluate the additional effect of a self-help guide, based on health behaviour theories and behaviour change techniques, on (i) successful completion of a TAC and (ii) changes in drinking refusal self-efficacy (DRSE), behavioural automaticity, craving, and alcohol consumption. Methods A randomized controlled trial was performed (OSF registries: OSF.IO/B95VU). NoThanks participants received a questionnaire before the TAC (T0) and 8 months after the TAC (T1). Out of a subgroup of 1308 respondents who were interested in additional support, 652 were randomly assigned to receive the guide (experimental group), and 656 did not receive any additional support (control group). Logistic regressions and (generalized) linear mixed model analyses were used. Results After 8 months, all participants showed a significant decrease in behavioural automaticity, craving, and alcohol consumption, irrespective of group assignment. No significant changes were observed in the DRSE. This degree of change over time in behavioural automaticity, craving, and alcohol consumption did not differ between the experimental and control group. Sensitivity analyses with participants in the experimental group, who differed in exposure to the guide, did not show differences either. Conclusion The self-help guide, and how it was designed, added no value to the TAC. Future research should focus on more bottom-up, customized support and explore what (different subgroups of) participants think they need as extra support during a TAC. [ABSTRACT FROM AUTHOR]

We investigated the effectiveness of a sustained and spiraled content literacy intervention that emphasizes building domain and topic knowledge schemas and vocabulary for elementary-grade students. The model of reading engagement intervention underscores thematic lessons that provide an intellectual structure for helping students connect new learning to a general schema in Grade 1 (animal survival), Grade 2 (scientific investigation of past events like dinosaur mass extinctions), and Grade 3 (scientific investigation of living systems). A total of 30 elementary schools (N = 2,870 students) were randomized to a treatment or control condition. In the treatment condition (i.e., full spiral curriculum), students participated in content literacy lessons from Grades 1 to 3 during the school year and wide reading of thematically related informational texts in the summer following Grades 1 and 2. In the control condition (i.e., partial spiral curriculum), students participated in lessons in only Grade 3. The Grade 3 lessons for both conditions were implemented online during the COVID-19 pandemic school year. Results reveal that treatment students outperformed control students on science vocabulary knowledge across all three grades. Furthermore, intent-to-treat analyses revealed positive transfer effects on Grade 3 science reading (ES =.14), domain-general reading comprehension (ES =.11), and mathematics achievement (ES =.12). Treatment impacts were sustained at 14-month follow-up on Grade 4 reading comprehension (ES =.12) and mathematics achievement (ES =.16). Findings indicate that a content literacy intervention that spirals topics and vocabulary across grades can improve students' long-term academic achievement outcomes. Public Significance Statement: This experimental study illustrates how sustaining and spiraling science schemas (background knowledge) and vocabulary from Grades 1 to 3 can improve students' ability to comprehend passages in science, English language arts, and mathematics. Furthermore, findings suggest that systematically building background and vocabulary knowledge can sustain positive gains in elementary-grade students' reading comprehension ability through the end of Grade 4, 14 months after the conclusion of the intervention activities. [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]

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

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]

Conventional treatments for allergic rhinitis (AR) exhibit insufficiency and long-term use-related side effects. Considering the reported anti-inflammatory and immunoregulatory effects of Bojungikgi-tang (BJIGT), we aimed to assess its efficacy on persistent AR (PAR). Patients with PAR were randomly assigned in a 1:1:1 ratio into high-dose BJIGT, standard-dose BJIGT, and placebo groups, followed by 1-week run-in and 4-week treatment periods. The primary outcome included the mean change in Total Nasal Symptom Score (TNSS), with secondary outcomes encompassing the Korean Allergic Rhinitis-Specific Quality of Life Questionnaire, biomarkers, overall assessment, TNSS by AR pattern identification, and the Sasang constitution. The mean TNSS change was more improved in the BJIGT group than in the placebo group; however, no statistically significant differences were observed. Additional interaction effect analysis revealed a statistically significant improvement in the high-dose BJIGT group compared with the placebo group from weeks 1–2 to weeks 3–4. Regarding secondary outcomes, the BJIGT group exhibited similar or improved results compared with the placebo group, showing no statistically significant differences. No serious adverse effects or clinically significant changes in safety assessments were observed. Given that this study validated clinical improvement and safety, it serves as potential groundwork for pertinent future studies. [ABSTRACT FROM AUTHOR]

Purpose: Depressive symptoms are prevalent among Chinese adolescents. However, there is a lack of effective prevention programs to reduce depressive symptoms. Methods: A pilot cluster randomized controlled trial was implemented in a sample of senior secondary school adolescents. Participants in the intervention group (N = 148) received a 6-week universal prevention course, whereas the control group (N = 131) received a routine course focusing on career development. Results: The linear mixed models showed that the group × time interaction was significant for depressive symptoms measured by DASS-21 (F (2, 550) = 5.72, p =.003) and marginally significant for that measured by SMFQ (F (2, 549) = 2.41, p =.09). Likewise, the level of anxiety and stress were significantly reduced after the program, but not maintained in the follow-up. Conclusions: This pilot study showed that a universal prevention program is promising in reducing adolescent depressive symptoms. [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]

Objective: Our ability to predict responsiveness to digital interventions for eating disorders has thus far been poor, potentially for three reasons: (1) there has been a narrow set of predictors explored; (2) prediction has mostly focused on symptom change, ignoring other aspects of the user journey (uptake, early engagement); and (3) there is an excessive focus on the unique effects of predictors rather than the combined contributions of a predictor set. We evaluated the univariate and multivariate effects of outcome predictors in the context of a randomized trial (n = 398) of digitally delivered interventions for recurrent binge eating. Method: Thirty baseline variables were selected as predictors, ranging from specific symptoms, to key protective factors, to technological acceptance, and to online treatment attitudes. Outcomes included uptake, early engagement, and remission. Univariate (d) and multivariate (D) standardized mean differences were calculated to estimate the individual and combined effects of predictors, respectively. Results: At the univariate level, few predictors produced an effect size larger than what is considered small (d >.20) across outcomes. However, our multivariate approach enhanced prediction (Ds =.65 to 1.12), producing accuracy rates greater than chance (63%–71% accuracy). Less than half of the chosen variables proved to be useful in contributing to predictions in multivariate models. Conclusion: Findings suggest that accuracy in outcome prediction from digitally delivered interventions may be better driven by the aggregation of many small effects rather than one or several largely influential predictors. Replication with different data streams (sensor, neuroimaging) would be useful. Public Significance: Our ability to predict who will and will not benefit from digital interventions for eating disorders has been poor. We highlight the viability of a multivariate approach to outcome prediction, whereby prediction may be better driven by the aggregation of many small effects rather than one or a few influential predictors. [ABSTRACT FROM AUTHOR]

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]

Mastectomy serves as the main surgical treatment for both invasive and in situ breast carcinoma and large phyllodes tumors. It is associated with skin necrosis, seroma, and surgical site infection in up to 30% of patients. In the present trial, we compared the complications in patients undergoing skin flap elevation by one of the 4 techniques: thick skin flap raised by scalpel(group1), thin skin flap raised with scalpel (group 2), thick skin flap raised with diathermy (group 3), and thin skin flap raised with diathermy (group 4). A randomized trial with superiority hypothesis and 2 × 2 factorial design was conducted at All India Institute of Medical Sciences New Delhi. Mastectomy skin flap necrosis (MSN) was recorded as the main outcome of interest. MSN was noted in 2.5% in group1, 10% in group 2, 7.5% in group 3, and 30% in group 4. MSN was observed in 5% cases with thick flap compared to 20% cases with a thin skin flap (p = 0.007). Raising the flap with scalpel was associated with MSN in 6.25% compared to 18.75% in the diathermy group (p = 0.029). We conclude that raising a thick flap with scalpel is associated with lowest risk of skin flap necrosis. Trial Registration: Clinical Trial Registry- India CTRI/2014/09/004978 [ABSTRACT FROM AUTHOR]

Background: There are many barriers to engaging in current psychological treatments, including time, cost, and availability. Ultra-brief treatments overcome some of these barriers by delivering therapeutic information and skills using significantly less time than standard-length treatments. We developed a therapist-guided online ultra-brief treatment for depression and anxiety and compared it to an existing 8-week, 5-lesson therapist-guided standard-length treatment and a waitlist control. Methods: In a randomized controlled trial, adults with self-reported depression or anxiety were randomized (1:1:1) to the ultra-brief treatment, standard-length treatment, or waitlist control. The primary outcomes were depression symptoms and anxiety symptoms assessed at baseline, 5-weeks later, 9-weeks later (primary timepoint), and 3-months later. The trial was prospectively registered. Results: Between 7 February 2022, and 16 August 2022, 242 participants were enrolled in the ultra-brief treatment (n = 85), standard-length treatment (n = 80), and waitlist control (n = 77). Participants were mostly women with an average age of 48.56 years. At 9-weeks post-baseline, participants in the ultra-brief treatment group reported significantly lower depression (between groups d = 0.41) and anxiety (d = 0.53) than the waitlist control. The ultra-brief treatment was non-inferior for anxiety at both 9-weeks and 3-months follow-up. Non-inferiority for depression was observed at 9-weeks. Conclusions: The online ultra-brief treatment resulted in significant reductions in depression and anxiety that were non-inferior to a longer treatment course after 9-weeks. Remotely delivered ultra-brief treatments have the potential to provide accessible and effective care for those who cannot, or would prefer not to, access longer psychological interventions. [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]

We report midline impacts of a community-randomized cash transfer intervention to 1857 vulnerable mothers in 140 rural cocoa-farming communities of Côte d'Ivoire. Compared to mothers in the comparison group who participated in village savings and loan associations (VSLAs), treatment mothers participated in VSLAs and received 8 € each week for up to one year with no conditions attached (the midway point of a two-year program). We find small- to moderate-sized treatment effects on four of six indicators of economic well-being (d = 0.23–0.75), as well as small reductions in maternal stress (d = −0.27). We find no statistically detectable impacts on educational engagement, educational aspirations, or educational expectations for children. Results suggest that cash transfer programs in rural West African communities can improve economic well-being and reduce maternal stress. Implications for children and families and for future cash transfer evaluations are discussed. [ABSTRACT FROM AUTHOR]

Mobile health applications (mHealth apps) may lead to health benefits. In recent years, the use of apps in multiple sclerosis (MS) has increased. Apps to train and improve dexterity in MS are scarce. This study investigated the effectiveness of a tablet app-based home-based training to improve dexterity in individuals with MS. In a randomized controlled trial, two standardized 4-week home-based interventions focussing on different aspects of dexterity and upper limb function were compared. Assessments were done at baseline, post-intervention and 12-week follow-up. The primary endpoint was the Arm Function in Multiple Sclerosis Questionnaire, a dexterity-related measure of patient-reported activities of daily living. Secondary endpoints were dexterous function, grip strength and health-related quality of life. Forty-eight individuals were randomly assigned to a tablet app-based program (n = 26) or a control strengthening exercise program (n = 22). No significant differences were found for the primary endpoint (p = 0.35). Some significant differences in favour of the app-group were found in fine coordinated finger movements and strength. No significant differences were found at the 12-week follow-up for all endpoints. Adherence in both groups was above 90%. App-based training was not superior compared to a control strengthening exercise program concerning the arm- and hand function from the participant's perspective. However, app-based training was found to be effective in improving specific dimensions (finger movements and strength), and can easily be applied at home. Therefore, individuals living with MS with impaired dexterity should consider app-based training. Clinicaltrials.gov NCT03369470. This study provides initial evidence for the effectiveness of a home-based app-based program for improving dexterous function in individuals living with multiple sclerosis through the implementation of a tablet app-based dexterity training. App-based training was not superior compared to a control strengthening exercise program concerning the arm- and hand function from the participant's perspective. Patients attending the app-based dexterity program showed some statistically significant improvements in fine coordinated finger movements and strength. [ABSTRACT FROM AUTHOR]

Objective: To investigate the immediate effects of electro-acupuncture (EA) on endometrial blood flow among recurrent implantation failure (RIF) patients. Methods: Eighty RIF patients, enrolled from March 2022 to December 2022, were randomly allocated into either the EA group (40 cases) or the waiting-list (WL) group (40 cases) by using a random number table. The EA group underwent acupuncture at points of Shenting (GV 24), Baihui (GV 4), Benshen (GB 13), bilateral Zigong (EX-CA 1), Huangshu (KI 16), Sanyinjiao (SP 6) and Xuehai (SP10), and electric acupuncture apparatus was connected to EX-CA 1, KI 16, SP 6, and SP 10 with disperse-dense waves at 4/20 Hz frequencies for 30 min after transvaginal ultrasound, while the WL group received no intervention. The primary outcome measured was the endometrial volume blood flow. The secondary outcomes included the bilateral uterine artery index, endometrial volume, endometrial blood flow type, vascular distribution index (VIMV) for endometrial and ovary, clinical pregnancy rate, and embryo implantation rate. Results: In the EA group, there was a notable decrease in the bilateral pulsatility index and a significant improvement in the endometrial blood flow type post-EA (P<0.05). Both the endometrial blood flow type and VIMV for the endometrium and right ovary were markedly higher in the EA group compared to the WL group post-treatment (P<0.05). Conversely, no significant disparities were observed in vascular index, flow index, vascular blood flow index, uterine arterial blood flow indices, endometrial volume, clinical pregnancy rate and embryo implantation rate between the two groups after treatment (P>0.05). Besides, no adverse events related to EA were observed. Conclusions: EA can promptly ameliorate VIMV for the endometrial and right ovary, and endometrial blood flow type. Future randomized controlled trials are warranted to investigate the long-term effects of EA on blood flow of RIF patients and its implications for pregnancy outcomes. (Trial registration No. ChiCTR2200057377) [ABSTRACT FROM AUTHOR]

BACKGROUND: Since the outbreak of the COVID-19 pandemic, university students have been exposed to a heightened vulnerability towards developing psychological issues, such as psychological distress and shyness. Internet-based interventions offer a convenient avenue for scalability, thus prompting the development of a smartphone-based hypnotic intervention aimed at addressing shyness among university students. OBJECTIVE: We devised an innovative smartphone-based hypnotic intervention called mHypnosis to examine its impact on shyness among undergraduate students. Furthermore, we aimed to investigate whether the apprehension of negative evaluations before treatment could serve as a predictor for the effectiveness of the intervention on shyness. METHODS: Eighty students with high shyness scores were randomly assigned to the experimental group and the control group. Another 40 participants with low shyness score were selected as the baseline group. The Shyness Scale (SS), Fear of Negative evaluation scale (FNE), Self-Acceptance Questionnaire (SAQ), and Self-Esteem Scale (SES) were used to evaluate the effect of hypnotic intervention. RESULTS: Before the intervention, the scores of the experimental and control groups on the SS, FNE, SAQ, and SES were higher than those in the baseline group (p < 0.05). There was no significant difference in scores between the experimental and control group (p > 0.05). After the intervention, the scores of the SS, FNE, SAQ, and SES were significantly lower in the experimental group than those in the control group (p < 0.05). The pretest score of FNE could predict the shyness score after hypnotic intervention (B = 0.35, p < 0.05). CONCLUSION: Smartphone-based hypnotic intervention had a significant effect on ameliorating shyness during the COVID-19 pandemic; fear of negative evaluation can be a target for treating shyness. [ABSTRACT FROM AUTHOR]

Acute exercise induces changes within the T-cell compartment, especially in cytotoxic CD8+ memory subsets, depending on exercise intensity and duration. It is unclear whether exercise-induced changes in major T-cell subsets differ in response to acute high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT) and whether sex-specific effects exist. Twenty-four recreationally active runners (females: n=12, 27.8±4.1years, 54.4±4.6 ml*kg-1 *min-1 ; males: n=12, 31.6±3.8years, 58.9±7.7 ml*kg-1 *min-1) participated in this randomized controlled crossover study, and conducted an energy- and duration-matched HIIT and MICT session. Blood was sampled before (T1), immediately (T2) and 1 h after exercise (T3). Flow cytometry was used to identify T-cell populations. HIIT decreased the proportion of CD8+ T-cells more pronounced at T3 compared to MICT (p=0.007), induced a significantly stronger increase in the CD8+ effector memory (TEM) cell proportion at T2 (p=0.032), and decreased CD4+ central memory proportion more pronounced at T2 (p=0.029). A decrease below baseline CD8+ TEM proportion at T3 was observed only after HIIT (p<0.001). No interaction effects between sexes were revealed. Taken together, HIIT represents a more potent stimulus to induce shifts mainly within the cytotoxic CD8+ T-cell compartment, thereby giving implications to investigate the role of HIIT on the cell´s effector phenotype and function in more detail. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction (TW) in treating patients with diabetic peripheral neuropathy (DPN). Methods: It is a multicenter double-blinded randomized controlled trial. Participants with DPN were recruited between November 18, 2016 and May 30, 2018 from 8 hospitals in China. All patients received basic treatments for glycemic management. Patients received foot baths with TW herbal granules either 66.9 g (intervention group) or 6.69 g (control group) for 30 min once a day for 2 weeks and followed by a 2-week rest, as a therapeutic course. If the Toronto Clinical Scoring System total score (TCSS-TS) ⩾6 points, the patients received a total of 3 therapeutic courses (for 12 weeks) and were followed up for 12 weeks. The primary outcome was change in TCSS-TS score at 12 and 24 weeks. Secondary outcomes included changes in bilateral motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the median and common peroneal nerve. Safety was also assessed. Results: Totally 632 patients were enrolled, and 317 and 315 were randomized to the intervention and control groups, respectively. After the 12-week intervention, patients in both groups showed significant declines in TCSSTS scores, and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment (P<0.05). The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group (P<0.05). The number of adverse events did not differ significantly between groups (P>0.05), and no serious adverse event was related with treatment. Conclusion: Treatment of TW foot baths was safe and significantly benefitted patients with DPN. A low dose of TW appeared to be more effective than a high dose. (Registry No. ChiCTR-IOR-16009331). [ABSTRACT FROM AUTHOR]

This randomized controlled trial aimed to assess the efficacy of the Homebound Elderly People Psychotherapeutic Intervention (HEPPI), a home-delivered cognitive-emotional intervention, among the homebound older population presenting with mild cognitive impairment and depressive or anxiety symptoms. Participants were randomly assigned either to the intervention group or the treatment-as-usual group and completed baseline, post-intervention, and three-month follow-up assessments. Changes in episodic memory and symptoms of depression and anxiety were the primary outcomes. Secondary outcomes included changes in global cognition, attentional control, subjective memory complaints, functional status, and quality of life. Data were analyzed on an intention-to-treat basis employing a linear mixed models approach. ClinicalTrials.gov identifier: NCT05499767. Compared with the treatment-as-usual group, the HEPPI group reported significant immediate improvement in cognition, mood, and daily functional performance. Positive effects of HEPPI were maintained over the follow-up phase only in depressive symptomatology, perceived incapacity to perform advanced instrumental activities of daily living, and self-reported emotional ability. A significant impact of the intervention on the subjective memory complaints level was observed only three months after the intervention. This study suggests that HEPPI may be a promising home-delivered cognitive-emotional intervention to help homebound older adults improve their mental health. [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]

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]

Background: In Traditional Chinese Medicine (TCM) theory, cold dampness obstruction is one of the common syndromes of osteoarthritis. Therefore, in clinical practice, the main treatment methods are to dispel wind, remove dampness, and dissipate cold, used to treat knee osteoarthritis (KOA). This report describes a mulitercenter clinical study to assess Zhuifeng Tougu Capsule's efficacy and safety in the treatment of patients who are cold dampness obstruction syndrome in KOA, and to provide evidence-based medical for the rational use of Zhuifeng Tougu Capsules in clinical practice. Methods: This randomized, parallel group controlled, double-blind, double dummy trial will include a total of 215 KOA patients who meet the study criteria. 215 patients underwent 1:1 randomisation, with 107 cases assigned the experimental group (Zhuifeng Tougu Capsules + Glucosamine Sulfate Capsules Simulator) and 108 assigned the control group (Glucosamine Sulfate Capsules + Zhuifeng Tougu Capsules Simulator). After enrolment, patients received 12 weeks of treatment. The main efficacy measure is the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score. Visual analogue scale (VAS) pain score, Self-condition assessment VAS score, WOMAC KOA score, TCM syndrome score and TCM syndrome efficacy, ESR level, CRP level, suprapatellar bursa effusion depth, use of rescue drugs, and safety indicators are secondary efficacy indicators. Results: Compared with before treatment, WOMAC pain score, VAS pain score, Self-condition assessment VAS score, WOMAC KOA score, and TCM syndrome score decreased significantly in both groups (P < 0.01). Also, the experimental group showed significant differences in the above indicators compared to control (P < 0.01). However, after treatment, no significant differences were showed in the ESR level, CRP level, and suprapatellar bursa effusion depth between the two groups (P > 0.05). No any serious adverse effects showed in the experimental group and control group. Conclusions: Zhuifeng Tougu Capsules can effectively improve knee joint function and significantly alleviate the pain of KOA. Trial registration: Clinical trial registration was completed with the China Clinical Trial Registration Center for this research protocol (No. ChiCTR2000028750) on January 2, 2020. [ABSTRACT FROM AUTHOR]