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Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone. [ABSTRACT FROM AUTHOR]

Background: Goals generated by Goal Attainment Scaling (GAS) can be used as an outcome measure to promote person-centred research and care. There are no training packages which support its use outside of the rehabilitation discipline. This paper describes the development and evaluation of a training package to support the implementation of GAS as an outcome measure in healthcare research. The training package consisted of classroom teaching, a training manual for self-directed learning, one-on-one simulation and hot reviews. It was developed for the GOAL Trial, a randomised controlled trial assessing a Comprehensive Geriatric Assessment's effectiveness in enabling frail older people living with chronic kidney disease to attain their goals. Training participants were invited to complete pre- and post-training online evaluation surveys. Results: Forty-two healthcare professionals attended an initial online classroom teaching, with 27 proceeding to administer GAS to GOAL Trial patients. Response rates for the online pre- and post-training surveys were 95% and 72%, respectively. Prior to training, only 15% of participants reported being able to appropriately scale and troubleshoot GAS goals. Post-training this was 92%. There was 100% participant satisfaction for the training manual, one-on-one simulation, and hot reviews. Conclusions: This training package helps ensure healthcare professionals administering GAS have adequate knowledge and skills. It has the potential for adoption as a guide to support the implementation of GAS by other researchers seeking to embrace persont-centred principles in their work. [ABSTRACT FROM AUTHOR]

Objective: This paper was aimed at unveiling the effect of low-molecular-weight heparin calcium (LMWH) combined with magnesium sulfate and labetalol on coagulation, vascular endothelial function, and pregnancy outcome in early-onset severe preeclampsia (EOSP). Methods: Pregnant women with EOSP were divided into the control group and the study group, each with 62 cases. Patients in the control group were treated with labetalol and magnesium sulfate, and those in the study group were treated with LMWH in combination with the control grou Blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), 24-h urine protein, coagulation indices [D-dimer (D-D), plasma fibrinogen (Fg), prothrombin time (PT), activated partial thromboplastin time (APTT), and prothrombin time (TT)], endothelial function [endothelin (ET-1) and nitric oxide (NO)], oxidative stress indices [oxidized low-density lipoproteins (ox-LDL), lipid peroxidation (LPO), superoxide dismutase (SOD), and malondialdehyde (MDA)], pregnancy outcome, and adverse effects occurred in the two groups were compared. Results: After treatment, lower SBP, DBP, and 24-h urine protein levels; lower Fg and D-D levels; higher PT, APPT, and TT levels; higher NO levels; lower ET-1 levels; lower ox-LDL, MDA, and LPO levels; higher SOD levels; and lower incidence of adverse pregnancy and adverse reactions were noted in the study group in contrast to the control group. Conclusion: EOSP patients given with LMWH combined with magnesium sulfate and labetalol can effectively reduce the patient's blood pressure and urinary protein level; improve coagulation function, oxidative stress, and vascular endothelial function indices; reduce the adverse pregnancy outcomes; and improve the safety of treatment. [ABSTRACT FROM AUTHOR]

Background: Limited data regarding the effects of school-based obesity prevention programs focusing on the changes in obesity-related knowledge and behaviors in China are available. The objective of this paper was to evaluate the effects of a school-based comprehensive lifestyle intervention among Chinese kids against obesity (CLICK-Obesity) in primary schools in Nanjing. Methods: We designed a cluster randomized controlled trial in eight randomly selected urban primary schools among 4th graders between May 2011 to April 2012 in Jianye, an urban district of Nanjing. Each school was randomly assigned to either the intervention or control group (four schools in each group). Mixed regression models and generalized estimating equations (GEE) were used to adjust for individual-level covariates under cluster randomization. Results: In this study, 1178 students (96.2%; 665 boys and 513 girls, 544 in control and 634 in intervention) participated in the baseline survey with mean age 10.2 ± 0.5 years. At the end of one-year intervention, 1125 students (91.8%; 628 boys and 497 girls, 513 in control and 612 in intervention) were reassessed. Notably, we found that the intervention group improved the knowledge and awareness of obesity-related risk factors, presented a lower increase of consumption of red/white meat (with a mean difference of −180.9 g/week, 95% CI: −350.6 to −11.2, p = 0.040), a larger increase in the time spent playing ball (with a mean difference of 24.2 min/week, 95% CI: −5.3 to 53.7, p = 0.090), and a significant reduction in screen time (with a mean difference of −71.0 min/week, 95% CI: −125.3 to −16.6, p = 0.020) compared to the control group after cluster (school) adjustment. Conclusion: The school-based integrated intervention was successful to modify unhealthy lifestyle behaviors and had a potential effect on childhood obesity prevention in urban China. However, the long-term effects and cost-effectiveness need to be evaluated in through further study. [ABSTRACT FROM AUTHOR]

Background: Traditional face-to-face cognitive behavioural therapy (CBT) has been successful at reducing fear of falling (FOF) in older people but can be labour-intensive and costly. Online CBT has been suggested as a cost-effective alternative but has not yet been tested in the context of FOF. This study evaluates the effectiveness of a readily available, self-guided and generalised online CBT program (myCompass) on reducing FOF in older people. Methods: Fifty community-dwelling older people with FOF received a paper-based health education program, and half were randomly assigned to receive three selected modules from myCompass for 6 weeks. The primary outcome was feared consequences of falling at 6 weeks. Secondary outcomes were concern about falling, balance confidence, activity avoidance, physical activity, exercise self-efficacy, health literacy and mental health at 6/26/52 weeks and falls incidence at 12 months. Results: All intervention participants completed at least 2-out-of-3 myCompass modules. There was a significant main effect of time on feared consequences of falling (Cohen's f = 0.55). The group by time interactions for concern about falling (f = 0.28), stress (f = 0.26) and social support for health (health literacy) (f = 0.26) was also significant, favouring the control group. The overall attrition rate at 12 months was 24% (n = 12). Conclusion: The high program compliance and low attrition rate suggest that online CBT is feasible among older people. However, the myCompass program had no effect at reducing FOF in older people. A more targeted CBT program with a well-integrated psychoeducation module on FOF might be the solution to boost the therapeutic effects of a generalised CBT program at reducing FOF for older people. [ABSTRACT FROM AUTHOR]

Electronic medication management (eMM) systems are designed to improve safety, but there is little evidence of their effectiveness in paediatrics. This study assesses the short-term (first 70 days of eMM use) and long-term (one-year) effectiveness of an eMM system to reduce prescribing errors, and their potential and actual harm. We use a stepped-wedge cluster randomised controlled trial (SWCRCT) at a paediatric referral hospital, with eight clusters randomised for eMM implementation. We assess long-term effects from an additional random sample of medication orders one-year post-eMM. In the SWCRCT, errors that are potential adverse drug events (ADEs) are assessed for actual harm. The study comprises 35,260 medication orders for 4821 patients. Results show no significant change in overall prescribing error rates in the first 70 days of eMM use (incident rate ratio [IRR] 1.05 [95%CI 0.92–1.21], but a 62% increase (IRR 1.62 [95%CI 1.28–2.04]) in potential ADEs suggesting immediate risks to safety. One-year post-eMM, errors decline by 36% (IRR 0.64 [95%CI 0.56–0.72]) and high-risk medication errors decrease by 33% (IRR 0.67 [95%CI 0.51–0.88]) compared to pre-eMM. In all periods, dose error rates are more than double that of other error types. Few errors are associated with actual harm, but 71% [95%CI 50–86%] of patients with harm experienced a dose error. In the short-term, eMM implementation shows no improvement in error rates, and an increase in some errors. A year after eMM error rates significantly decline suggesting long-term benefits. eMM optimisation should focus on reducing dose errors due to their high frequency and capacity to cause harm. [ABSTRACT FROM AUTHOR]

Recently, dance has become a therapeutic and rehabilitative intervention for individuals with Parkinson's disease (PD). Compared with traditional gait training or other rehabilitative interventions, dance appears to be a safe, fun, and an alternative way to achieve functional changes and improvements in mobility, gait, balance, and quality of life. This paper reviews literature regarding dance and PD in terms of enrollment size, dosage and frequency of intervention, class size, comparison or control groups, outcome measures, and effect size. A search was conducted on PubMed, Web of Sciences, Cochrane Library, and Google Scholar using the terms 'dance' and 'Parkinson's disease.' Ten papers were included in this review: seven of which examined walking speed, nine that included measures of balance, one study that examined upper extremity function, eight studies that measured disability rating, and one study that examined falls. Only five studies had control groups, three of which were active control groups. Various studies have clinical design issues such as inclusion of a control group, outcome measures or the way in which the intervention was administered. Essential outcome measures to include are safety, tolerability, quality of life, and falls. These measures determine information on treatment effects, adverse event rates, and dropout rates. [ABSTRACT FROM AUTHOR]

Background: ARCHER 1050, an ongoing, randomized, open-label, phase III trial of dacomitinib versus gefitinib in newly diagnosed patients with advanced non-small-cell lung cancer (NSCLC) and an EGFR-activating mutation, reported significant improvement in overall survival (OS) with dacomitinib. Objective: This paper reports an updated OS analysis of ARCHER 1050 after an extended follow-up. Patients and methods: In this multinational, multicenter trial, adults (aged ≥ 18 years or ≥ 20 years in Japan and Korea) with newly diagnosed NSCLC and EGFR mutation (exon 19 deletion or exon 21 L858R substitution), and no history of central nervous system metastases, were randomized 1:1 to receive dacomitinib 45 mg/day (n = 227) or gefitinib 250 mg/day (n = 225). Randomization was stratified by race and EGFR mutation type. An ad hoc updated analysis of OS was conducted at the protocol-defined cut-off of 48 months from first dosing of the last enrolled patient (13 May 2019). Results: After a median follow-up of 47.9 months, 133 (58.6%) patients had died in the dacomitinib arm and 152 (67.6%) in the gefitinib arm. The hazard ratio (HR) for OS was 0.748 (95% CI 0.591–0.947; two-sided P = 0.0155); median OS was 34.1 months with dacomitinib versus 27.0 months with gefitinib. The HR for OS in patients with dose reduction(s) in the dacomitinib arm (n = 154) compared with all patients in the gefitinib arm was 0.554 (95% CI 0.420–0.730); median OS was 42.5 months for patients with dose reduction(s) in the dacomitinib arm. The most common adverse events were diarrhea (87.7%), paronychia (61.7%), dermatitis acneiform (49.3%), and stomatitis (43.6%) with dacomitinib, and diarrhea (55.8%) and alanine aminotransferase increased (40.2%) with gefitinib. Conclusions: The OS benefit from first-line treatment with dacomitinib versus gefitinib was maintained after extended follow-up in patients with advanced NSCLC with EGFR-activating mutations. ClinicalTrials.gov: NCT01774721 (registered 24 January 2013). [ABSTRACT FROM AUTHOR]

Background: Non-adherence to medications is prevalent across all medical conditions that include ambulatory pharmacotherapy and is thus a major barrier to achieving the benefits of otherwise effective medicines. Objective: The objective of this systematic review was to identify and to compare the efficacy of strategies and components thereof that improve implementation of the prescribed drug dosing regimen and maintain long-term persistence, based on quantitative evaluation of effect sizes across the aggregated trials. Data sources: MEDLINE, EMBASE, CINAHL, the Cochrane Library, and PsycINFO were systematically searched for randomized controlled trials that tested the efficacy of adherence-enhancing strategies with self-administered medications. The searches were limited to papers in the English language and were included from database inception to 31 December 2011. Study selection: Our review included randomized controlled trials in which adherence was assessed by electronically compiled drug dosing histories. Five thousand four hundred studies were screened. Eligibility assessment was performed independently by two reviewers. A structured data collection sheet was developed to extract data from each study. Study appraisal and synthesis methods: The adherence-enhancing components were classified in eight categories. Quality of the papers was assessed using the criteria of the Cochrane Handbook for Systematic Reviews of Interventions guidelines to assess potential bias. A combined adherence outcome was derived from the different adherence variables available in the studies by extracting from each paper the available adherence summary variables in a pre-defined order (correct dosing, taking adherence, timing adherence, percentage of adherent patients). To study the association between the adherence-enhancing components and their effect on adherence, a linear meta-regression model, based on mean adherence point estimates, and a meta-analysis were conducted. Results: Seventy-nine clinical trials published between 1995 and December 2011 were included in the review. Patients randomized to an intervention group had an average combined adherence outcome of 74.3 %, which was 14.1 % higher than in patients randomized to the control group (60.2 %). The linear meta-regression analysis with stepwise variable selection estimated an 8.8 % increase in adherence when the intervention included feedback to the patients of their recent dosing history (EM-feedback) ( p < 0.01) and a 5.0 % increase in adherence when the intervention included a cognitive-educational component ( p = 0.02). In addition, the effect of interventions on adherence decreased by 1.1 % each month. Sensitivity analysis by selecting only high-quality papers confirmed the robustness of the model. The random effects model in the meta-analysis, conducted on 48 studies, confirmed the above findings and showed that the improvement in adherence was 19.8 % (95 % CI 10.7-28.9 %) among patients receiving EM-feedback, almost double the improvement in adherence for studies that did not include this type of feedback [10.3 % (95 % CI 7.5-13.1 %)] ( p < 0.01). The improvement in adherence was 16.1 % (95 % CI 10.7-21.6 %) in studies that tested cognitive-educational components versus 10.1 % (95 % CI 6.6-13.6 %) in studies that did not include this type of intervention ( p = 0.04). Among 57 studies measuring clinical outcomes, only 8 reported a significant improvement in clinical outcome. Limitations: Despite a common measurement, the meta-analysis was limited by the heterogeneity of the pooled data and the different measures of medication adherence. The funnel plot showed a possible publication bias in studies with high variability of the intervention effect. Conclusions: Notwithstanding the statistical heterogeneity among the studies identified, and potential publication bias, the evidence from our meta-analysis suggests that EM-feedback and cognitive-educational interventions are potentially effective approaches to enhance patient adherence to medications. The limitations of this research highlight the urgent need to define guidelines and study characteristics for research protocols that can guide researchers in designing studies to assess the effects of adherence-enhancing interventions. [ABSTRACT FROM AUTHOR]

Background: Suicide is a leading cause of death in the United States with rates increasing over the past two decades. The rate of suicide is higher in rural areas, but a greater number of people in urban areas die by suicide; understanding risk factors for suicide in this context is critically important to public health. Additionally, while many studies have focused on individual-level risk factors, few studies have identified social or structural features associated with suicide or firearm suicide, especially among young people. Methods: Study outcomes included total firearm suicide, total youth (age 10–29) firearm suicide, total suicide, and total youth suicide in Detroit, Michigan from 2012 through 2019. The predictors in this study included 58 census-tract level variables characterizing the physical features, residential stability, socioeconomic status, and demographics of neighborhoods in Detroit over the study period. We used random forest, extreme gradient boosting (XGBoost), and generalized linear mixed models to predict the four outcomes. Results: We found that the tract-level variables used in all three modeling approaches performed poorly at predicting the suicide outcomes, with area under the curve values at times exceeding 0.60 but with extremely low sensitivity (ranging from 0.05 to 0.45). However, the percentage of parcels sold in arms-length transfers in the previous 5 years, the count of vacant lots per square mile, and the percentage of children aged three and older who were enrolled in preschool each demonstrated associations with at least two of the outcomes studied. Conclusions: Our findings suggest place-based factors at the tract level do not provide meaningful insight into the risk of suicide or firearm suicide among youth or the general population in Detroit, Michigan. Future practice and study should consider focusing on both larger and smaller areas, including city and individual-level factors. For example, studies might benefit from the use of both neighborhood and individual-level measures and their interactions to improve our understanding of place-based risk factors and suicide risk. [ABSTRACT FROM AUTHOR]

Mindfulness-Based Cognitive Therapy (MBCT) interventions have become widely used to improve psychological outcomes for various populations and shown effective in reducing symptoms of anxiety and depression. Psychodynamic defense mechanisms have been considered an important process underlying mental disorders, however this has not been studied. The current study aimed to investigate whether MBCT affected (1) psychodynamic defense mechanisms and (2) mindfulness scores, and (3) whether this in turn was associated with any changes in depression and anxiety symptoms. This was an exploratory analysis of a randomized controlled trial of MBCT vs. treatment-as-usual for late-life depression and anxiety in older adults (n = 48). Study outcomes included psychodynamic defense mechanisms (DSQ-40), mindfulness (CAMS-R), depression (PHQ-9), and anxiety (GAD-7), and were assessed at baseline and 8-week. No significant changes were found in defense mechanisms, although the intervention group showed a general non-significant tendency toward increasing mature defenses (Cohen's D = 0.21), with decreasing neurotic (D = 0.35), and immature defenses (D = 0.37). Reductions in immature defense scores were associated with reductions in anxiety scores (r = 0.31, p < 0.05). MBCT was also associated with higher increases in mindfulness scores (MBCT + 2.26 vs. TAU − 1.20, t(46) = 2.40, p = 0.021), which in turn were associated with a greater reduction in depression (r=-0.44, p = 0.002) and anxiety scores (r=-0.48, p = 0.001). MBCT improves mindfulness and symptoms of depression and anxiety. Significant correlations were found between reductions in defense mechanisms and reductions in depression/anxiety symptoms. Future larger RCTs are needed to investigate the impact of MBCT on psychodynamic defense mechanisms. [ABSTRACT FROM AUTHOR]

Effective care coordination is a key quality and safety strategy for populations with chronic conditions, including children with medical complexity (CMC). However, gaps remain in parent report of the need for care coordination help and receipt of care coordination help. New models must close this gap while maintaining family-centered focus. A three-armed randomized controlled trial conducted in an established medical home utilized an advanced practice registered nurse intervention based on Presler's model of clinic-based care coordination. The model supported families of CMC across settings using telephone only or telephone and video telehealth care coordination. Effectiveness was evaluated from many perspectives and this paper reports on a subset of outcomes that includes family-centered care (FCC), need for care coordination help and adequacy of care coordination help received. FCC at baseline and end of study showed no significant difference between groups. Median FCC scores of 18.0-20.0 across all groups indicated high FCC within the medical home. No significant differences were found in the need for care coordination help within or between groups and over time. No significant difference was found in the adequacy of help received between groups at baseline. However, this indicator increased significantly over time for both intervention groups. These findings suggest that in an established medical home with high levels of FCC, families of CMC have unmet needs for care coordination help that are addressed by the APRN telehealth care coordination model. [ABSTRACT FROM AUTHOR]

African American/Black and Hispanic persons living with HIV/AIDS ('AABH-PLHA') are under-represented in HIV/AIDS medical studies (HAMS). This paper evaluates the efficacy of a social/behavioral intervention to increase rates of screening for and enrollment into HAMS in these populations. Participants (N = 540) were enrolled into a cluster randomized controlled trial of an intervention designed to overcome multi-level barriers to HAMS. Primary endpoints were rates of screening for and enrollment into therapeutic/treatment-oriented and observational studies. Intervention arm participants were 30 times more likely to be screened than controls (49.3 % vs. 3.7 %; p < .001). Half (55.5 %) of those screened were eligible for HAMS, primarily observational studies. Nine out of ten found eligible enrolled (91.7 %), almost all into observational studies (95.2 %), compared to no enrollments among controls. Achieving appropriate representation of AABH-PLHA in HAMS necessitates modification of study inclusion criteria to increase the proportion found eligible for therapeutic HAMS, in addition to social/behavioral interventions. [ABSTRACT FROM AUTHOR]

Background: Large conductance calcium-activated potassium (BKCa) channels have been implicated in the neurobiological underpinnings of migraine. Considering the clinical similarities between migraine and persistent post-traumatic headache (PPTH), we aimed to examine whether MaxiPost (a BKCa channel opener) could induce migraine-like headache in persons with PPTH. Methods: This is a randomized double-blind, placebo-controlled, two-way crossover study from September 2023 to December 2023. Eligible participants were adults with PPTH after mild traumatic brain injury who reported having no personal history of migraine. The randomized participants received a single dose of either MaxiPost (0.05 mg/min) or placebo (isotonic saline) that was infused intravenously over 20 minutes. The two experiment sessions were scheduled at least one week apart to avoid potential carryover effects. The primary endpoint was the induction of migraine-like headache after MaxiPost as compared to placebo within 12 hours of drug administration. The secondary endpoint was the area under the curve (AUC) values for headache intensity scores between MaxiPost and placebo over the same 12-hour observation period. Results: Twenty-one adult participants (comprising 14 females and 7 males) with PPTH were enrolled and completed both experiment sessions. The proportion of participants who developed migraine-like headache was 11 (52%) of 21 participants after MaxiPost infusion, in contrast to four (19%) participants following placebo (P =.02). Furthermore, the median headache intensity scores, represented by AUC values, were higher following MaxiPost than after placebo (P <.001). Conclusions: Our results indicate that BKCa channel opening can elicit migraine-like headache in persons with PPTH. Thus, pharmacologic blockade of BKCa channels might present a novel avenue for drug discovery. Additional investigations are nonetheless needed to confirm these insights and explore the therapeutic prospects of BKCa channel blockers in managing PPTH. ClinicalTrials.gov Identifier: NCT05378074. [ABSTRACT FROM AUTHOR]

Background: The objective was to compare sevoflurane, a volatile sedation agent with potential bronchodilatory properties, with propofol on respiratory mechanics in critically ill patients with COPD exacerbation. Methods: Prospective study in an ICU enrolling critically ill intubated patients with severe COPD exacerbation and comparing propofol and sevoflurane after 1:1 randomisation. Respiratory system mechanics (airway resistance, PEEPi, trapped volume, ventilatory ratio and respiratory system compliance), gas exchange, vitals, safety and outcome were measured at inclusion and then until H48. Total airway resistance change from baseline to H48 in both sevoflurane and propofol groups was the main endpoint. Results: Sixteen patients were enrolled and were sedated for 126 h(61–228) in the propofol group and 207 h(171–216) in the sevoflurane group. At baseline, airway resistance was 21.6cmH2O/l/s(19.8–21.6) in the propofol group and 20.4cmH2O/l/s(18.6–26.4) in the sevoflurane group, (p = 0.73); trapped volume was 260 ml(176–290) in the propofol group and 73 ml(35–126) in the sevoflurane group, p = 0.02. Intrinsic PEEP was 1.5cmH2O(1–3) in both groups after external PEEP optimization. There was neither early (H4) or late (H48) significant difference in airway resistance and respiratory mechanics parameters between the two groups. Conclusions: In critically ill patients intubated with COPD exacerbation, there was no significant difference in respiratory mechanics between sevoflurane and propofol from inclusion to H4 and H48. [ABSTRACT FROM AUTHOR]

Background: Palmitoylethanolamide (PEA) has analgesic/anti-inflammatory properties that may be a suitable alternative to over-the-counter (OTC) non-steroidal analgesics/anti-inflammatories. While OTC pain medications can impair strength training adaptations, the mechanism of action of PEA is distinct from these and it may not negatively affect skeletal muscle adaptations to strength training. Methods: The primary aim of this study was to investigate the effects of daily PEA supplementation (350 mg Levagen + equivalent to 300 mg PEA) combined with 8-weeks of resistance training on lean body mass with secondary aims addressing strength, power, sleep, and wellbeing compared to placebo (PLA) in young, healthy, active adults. In a randomized, controlled, double-blinded trial, 52 untrained, recreationally active participants aged 18–35 y were allocated to either the PEA or PLA groups. Participants consumed either 2 × 175 mg Levagen + PEA or identically matched maltodextrin capsules during an 8-week period of whole-body resistance training. This trial assessed the pre- to post- changes in total and regional lean body mass, muscular strength (1-RM bench, isometric mid-thigh pull), muscular power [countermovement jump (CMJ), bench throw], pain associated with exercise training, sleep, and wellbeing compared with the PEA or PLA condition. Results: 48 Participants were included in the final intention to treat (ITT) analysis and we also conducted per protocol (PP) analysis (n = 42). There were no significant between-group differences for total or regional lean muscle mass post-intervention. There was a significantly higher jump height (CMJ) at week 10 in the PEA group compared to the PLA (Adjusted mean difference [95% CI] p-value; ITT: − 2.94 cm [− 5.15, − 0.74] p = 0.010; PP: − 2.93 cm [− 5.31, − 0.55] p = 0.017). The PLA group had higher 1-RM bench press post-intervention compared with the PEA group (ITT: 2.24 kg [0.12, 4.37] p = 0.039; PP: 2.73 kg [0.40, 5.06] p = 0.023). No significant treatment effects were noted for any of the other outcomes. Conclusion: PEA supplementation, when combined with 8 weeks of strength training, did not impair lean mass gains and it resulted in significantly higher dynamic lower-body power when compared with the PLA condition. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR: ACTRN12621001726842p). Key Findings: Palmitoylethanolamide (PEA) is a compound that works as an anti-inflammatory and analgesic for the management of pain that works on different biochemical pathways compared to other over-the-counter analgesics and non-steroidal anti-inflammatories. Our findings indicate that a daily dose of 300 mg of PEA administered during 8-weeks of strength training did not interfere with skeletal muscle hypertrophy gains and may improve lower body power (e.g., jump height) compared to the placebo group. PEA may fill the gap for athletes and the active population as an alternative method of pain management. [ABSTRACT FROM AUTHOR]

6–11-year-old children provide a critical window for physical activity (PA) interventions. The Virtual Fitness Buddy ecosystem is a precision health PA intervention for children integrating mixed reality technology to connect people and devices. A cluster randomized, controlled trial was conducted across 19 afterschool sites over two 6-month cohorts to test its efficacy in increasing PA and decreasing sedentary behavior. In the treatment group, a custom virtual dog via a mixed reality kiosk helped children set PA goals while sharing progress with parents to receive feedback and support. Children in the control group set PA goals using a computer without support from the virtual dog or parents. 303 children had 8+ hours of PA data on at least one day of each of the 3 intervention time intervals. Conversion of sedentary time was primarily to light-intensity PA and was strongest for children with low baseline moderate-to-vigorous PA than children above 45 min of baseline moderate-to-vigorous PA. Findings suggest that the VFB ecosystem can promote sustainable PA in children and may be rapidly diffused for widespread public health impact. [ABSTRACT FROM AUTHOR]

Background: The Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youth (MADDY) study evaluated the efficacy and safety of a multinutrient formula for children with ADHD and emotional dysregulation. The post-RCT open-label extension (OLE) compared the effect of treatment duration (8 weeks vs 16 weeks) on ADHD symptoms, height velocity, and adverse events (AEs). Methods: Children aged 6–12 years randomized to multinutrients vs. placebo for 8 weeks (RCT), received an 8–week OLE for a total of 16 weeks. Assessments included the Clinical Global Impression-Improvement (CGI-I), Child and Adolescent Symptom Inventory-5 (CASI-5), Pediatric Adverse Events Rating Scale (PAERS), and anthropometric measures (height and weight). Results: Of the 126 in the RCT, 103 (81%) continued in the OLE. For those initially assigned to placebo, CGI-I responders increased from 23% in the RCT to 64% in the OLE; those who took multinutrients for 16 weeks increased from 53% (RCT) to 66% responders (OLE). Both groups improved on the CASI-5 composite score and subscales from week 8 to week 16 (all p–values < 0.01). The group taking 16 weeks of multinutrients had marginally greater height growth (2.3 cm) than those with 8 weeks (1.8 cm) (p = 0.07). No difference in AEs between groups was found. Conclusion: The response rate to multinutrients by blinded clinician ratings at 8 weeks was maintained to 16 weeks; the response rate in the group initially assigned to placebo improved significantly with 8 weeks of multinutrients and almost caught up with 16 weeks. Longer time on multinutrients did not result in greater AEs, confirming an acceptable safety profile. [ABSTRACT FROM AUTHOR]

Purpose A multifaceted implementation strategy was targeted at supervisors to encourage them to apply a participatory approach (PA) in dealing with employees' work functioning problems due to health concerns. This paper assesses the effect on employees' perceived social norms regarding the use of the PA to deal with work functioning problems. Methods Three organizations participated in a cluster randomized controlled trial, with randomization at the department level. Supervisors in the PA intervention departments received the implementation strategy consisting of a working group meeting, supervisor training, and optional coaching. Supervisors in the control departments received written information about the PA only. In two of the organizations, employees were invited to complete surveys at baseline and at 6-month follow-up. The primary outcome was perceived social norms regarding the use of the PA to deal with work functioning problems. Secondary measures included attitudes and self-efficacy, and intention regarding joint problem solving, and sick leave data. Effects were analyzed using multilevel analyses to account for nesting of cases. Results At baseline, 273 employees participated in the survey, with follow-up analyses of 174 employees. There were no statistically significant group effects on employee outcome measures. The intervention group showed a larger reduction in mean sick days (from 4.6 to 2.4 days) versus the control group (from 3.8 to 3.6 days), but this difference did not reach statistical significance ( p > .05). Conclusion The multifaceted strategy to implement the participatory approach for supervisors did not show effects on outcomes at the employee level. To gain significant effects at the employee level, may require that an implementation strategy not only targets management and supervisors, but also employees themselves. Trial registration: NTR3733. [ABSTRACT FROM AUTHOR]

Purpose: Sexual violence (SV) and adolescent relationship abuse (ARA) are common in the U. S. and have strong associations with negative health and wellbeing outcomes. Manhood 2.0 is the first U.S. program designed for community settings to build bystander skills while also challenging harmful gender norms. A cluster-randomized trial comparing Manhood 2.0 to Job Skills, a job readiness training control condition, demonstrated that it is a promising strategy to prevent sexual violence and adolescent relationship abuse. Such community-based interventions may be particularly relevant in lower resource urban settings, and the costs of such prevention programs have not been considered previously. Methods: The aim of the present study is to perform systematic and standardized cost calculations associated with implementing Manhood 2.0 among adolescent males. In addition, this study provides detailed cost information of the community-based intervention program, as well as costs associated with implementing the Job Skills control program. Program implementation data were recorded throughout the study period (2015–2019) by the Manhood 2.0 study team. Results: The cost of implementing Manhood 2.0 is $4,771 per complete round of program delivery and $451 per participant, which is approximately the same cost as the control Job Skills program ($4,432 and $453 per participant). The marginal cost per additional round of Manhood 2.0 program is $3,682. Conclusion: Implementation of a community-based program requires substantial resources and collaborations with community partners especially in economically disadvantaged neighborhoods. This study provides a snapshot of the cost information of a community-based intervention program from the implementing agency's perspective, which is essential in helping decision-makers understand the costs they will incur by implementing prevention programs and ensuring program feasibility and sustainability. [ABSTRACT FROM AUTHOR]

Copyright of AIDS & Behavior is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Insufficient data are available on the effects of long-term whey protein (WP) consumption on patients with type 2 diabetes mellitus (T2DM). So, in this study, we aimed to examine the effects of WP combined with individualized diet on anthropometric parameters, resting energy expenditure (REE), oxidative stress markers, and appetite among overweight/obese women with T2DM. Methods: In this 3-month double-blind placebo-controlled randomized clinical trial, 48 women with T2DM were randomly allocated into either WP group (one bread fortified by 20 g whey protein concentrates (WPC)) or placebo group (one unfortified bread) along with their individualized diets. At both pre- and post-intervention phases, physical activity, anthropometric parameters, REE, appetite, and serum levels of total antioxidant capacity (TAC) and malondialdehyde (MDA) as well as diet were assessed. Results: Thirty-five patients completed the trial. At the endpoint, there were no significant between-group differences for anthropometric parameters (p > 0.05), except for waist circumference (WC), which was lower in the WP group after adjusting for the confounders (p = 0.040). Serum level of MDA was significantly decreased in the WP group (p = 0.022). There were no significant within- or between-group changes for serum levels of TAC, REE, and appetite sensations (p > 0.05), except for the "hunger", which was lower in the WP group after adjusting for the confounders (p = 0.045). Conclusion: Regarding significant reduction in WC, serum levels of MDA, and feeling of hunger, consumption of the WPC fortified bread could be beneficial in women with T2DM. Registration Number: IRCT20110123005670N26; Registration date: 2019/01/07. [ABSTRACT FROM AUTHOR]

Early childhood is a crucial time for developing social-emotional skills, offering the opportunity to lay the foundation for healthy development. However, early childhood behavior problems are risk factors for problems and disorders in later life phases, including depression, antisocial behavior, and substance abuse. This study uses a longitudinal design to examine the differential impact of a preventive intervention and social-emotional learning program (Papilio-3to6) on children's social-emotional development. The program was evaluated using a 1-year-randomized controlled trial design with an intervention (IG) and control group (CG) that provided data at a pretest and post-test. Teachers rated 627 children's behaviors (MAGE = 56.77 months at pretest) from 50 daycare center groups using the Strengths and Difficulties Questionnaire (SDQ). To investigate differential effectiveness, a latent profile analysis at the pretest identified three distinct subgroups of children with different patterns in SDQ subscales: 1) Internalizers with high internalizing problems, 2) Prosocials with high prosocial behaviors, and 3) Externalizers with high externalizing problems. Latent change score analysis showed significantly reduced externalizing problems and increased prosocial behaviors in the IG compared to the CG. Further, the children categorized as Internalizers, Prosocials, and Externalizers benefited from the program regarding externalizing problems. However, no effect was found regarding internalizing problems. Highlights: Taking a person-centered approach, a three-class model of SDQ subscales, including Internalizers, Prosocials, and Externalizers, was chosen as the best-fitting model. Children in the intervention group showed a greater reduction in externalizing problems and a greater increase in prosocial behaviors compared to the control group of children. The children categorized as Internalizers, Prosocials, and Externalizers benefited from the program regarding externalizing problems. No intervention effects were found regarding internalizing problems. [ABSTRACT FROM AUTHOR]

Background: Psychological distress is highly noticeable among caregivers working in residential youth care (RYC). Maintaining and enhancing caregivers' professional mental health and quality of life is crucial to achieve effective outcomes in RYC. Nevertheless, trainings to protect caregivers' mental health are scarce. Considering the buffering effect over negative psychological outcomes, compassion training could be beneficial in RYC. Objective: This study is part of a Cluster Randomized Trial examining the effects of the Compassionate Mind Training for Caregivers (CMT-Care Homes), looking at professional quality of life and mental health of caregivers working in RYC. Method: The sample was composed of 127 professional caregivers from 12 Portuguese residential care homes (RCH). RCHs were randomly allocated at experimental (N = 6) and control group (N = 6). Participants were assessed at baseline, post-treatment, and 3 and 6-month follow-ups, answering to the Professional Quality of Life Scale and the Depression, Anxiety and Stress Scale. Program effects were tested using a two-factor mixed MANCOVA, with self-critical attitude and education degree as covariates. Results: MANCOVA showed a significant Time × Group interaction effects (F = 1.890, p =.014; η p 2 =.050), with CMT-Care Homes participants presenting lower scores on burnout, anxiety, and depression at 3 and 6-months follow-ups, when compared with controls. Participants that received CMT-Care Homes considered the program useful to deal with pandemic threats and with youth during lockdowns. Conclusion: This study shows the benefits of the CMT-Care Homes in helping professional caregivers reducing burnout, anxiety and depression, and dealing with pandemic challenges in RYC. Trial registration: This cluster randomized trial was registered at ClinicalTrials.gov (TRN: NCT04512092) on 6th August 2020. [ABSTRACT FROM AUTHOR]

To evaluate the effect of yoga on the frequency of MetS and its impact on cardiovascular risk markers in climacteric women. We recruited 84 sedentary women between 40 and 65 years diagnosed with MetS. Participants were randomly assigned to a 24-week yoga intervention or control group. We evaluated the frequency of MetS and changes in the individual components of MetS at baseline and after 24 weeks. We also assessed the impact of yoga practices on cardiovascular risk through the following markers: High-sensitivity C-reactive Protein (hs-CRP), Lipid Accumulation Product (LAP), Visceral Adiposity Index (VAI), and Atherogenic Index of Plasma (AIP). The frequency of MetS reduced significantly after 24 weeks of yoga practice (− 34.1%; p < 0.001). Statistical analysis showed that the frequency of MetS was significantly lower in the yoga group (65.9%; n = 27) than in the control group (93.0%; n = 40) after 24 weeks (p = 0.002). Regarding the individual components of MetS, yoga practitioners had statistically lower waist circumference, systolic blood pressure, triglycerides, HDLc, and glucose serum concentrations than the control group after 24 weeks. Yoga practitioners also had a significant decrease in hs-CRP serum concentrations (3.27 ± 2.95 mg/L vs. 2.52 ± 2.14 mg/L; p = 0.040) and a lower frequency of moderate or high cardiovascular risk (48.8% vs. 34.1%; p = 0.001) after 24 weeks of practice. The yoga group had LAP values significantly lower than the control group after the intervention period (55.8 ± 38.04 vs. 73.9 ± 40.7; p = 0.039). Yoga practice demonstrated to be an effective therapeutic to manage MetS and reduce cardiovascular risk in climacteric women. [ABSTRACT FROM AUTHOR]

Backgrounds and Objectives: The use of anti-inflammatory supplements is important in improving the executive function of obese people. This research aims to investigate the effect of 6 weeks of aerobic exercise with moderate intensity as well as the consumption of nanocurcumin on IL1β, nitric oxide (NO), and depression in women aged 60–65 with metabolic syndrome. Materials and Methods: Fourty-four women with metabolic syndrome were randomly selected and divided into four groups of 10 based on their use of nanocurcumin supplement. The treatment included the training (T), nanocurcumin (N), training + nanocurcumin (TN), and the control groups. The groups exposed to training performed aerobic exercise for 6 weeks (three sessions per week). Blood samples were obtained before and after the training period for antioxidant indicators and lipid degradation measurement. Also, the Beck anxiety questionnaire was used for evaluating levels of anxiety. T-test and one-way analysis of variance (ANOVA) tests were used for the assessment of within-group and between-group differences, respectively. Results: There was a significant difference in IL1β, NO, and depression before and after exercise in all three experimental groups (p ≤ 0.05). Also, the results showed a significant difference in the level of NO and depression in the experimental groups. The highest decrease in these variables was observed in the T and TN groups (p ≤ 0.05). Conclusion: These findings indicated that 6-week nanocurcumin supplementation with aerobic training is a suitable method for reducing IL1β, NO, and depression, preventing metabolic, cardiovascular, and inflammatory diseases in women with metabolic syndrome. Name of the registry: IR.SEMUMS.REC.1396.107 Trial registration number: IRCT2017082335857N1 [ABSTRACT FROM AUTHOR]

Purpose: To analyze the characteristics of overlapping meta-analyses based on randomized controlled trials (RCTs) which reported PD-1/PD-L1 inhibitors in non-small cell cancer (NSCLC). Methods: Meta-analyses were identified from English and Chinese databases until January 1, 2022. Differences in characteristics of overlapping meta-analyses that conducted in China and other countries were compared to assess their publication propensity. The corrected covered area (CCA) and coverage of relevant RCTs were analyzed for subtopics according to detailed intervention types. The waste and redundancy of evidence were assessed in the case of PD-1/PD-L1 inhibitor monotherapy for second-line treatment for NSCLC. Results: Fifty-nine meta-analyses published in English and 17 meta-analyses published in Chinese reporting 26 RCTs were identified. Fifty-three (69.74%) meta-analyses were conducted in China. The overlapping meta-analyses in China were more likely to be from hospitals, supported by government funding, integrate first and second-line therapies. Five of the six subtopics had overlapping meta-analyses according to specific types of interventions. The CCA of overlapping meta-analyses ranged from 33.33 to 63.19%, and the coverage of relevant RCTs ranged from 63.64 to 100%. All the conclusions of overlapping meta-analyses have been consistent in the subtopic of PD-1/PD-L1 inhibitor monotherapy for second-line treatment since 2017. Conclusion: Overlapping meta-analyses of PD-1/PD-L1 inhibitors in NSCLC hints that meta-analyses under this topic probably exist serious redundancy. Future research should focus on prospective registration of protocols for systematic reviews/meta-analyses, scientific designed PICO, and cumulative meta-analysis to reduce redundant and wasted studies. Journals should strengthen the requirement for reviewing previously published evidence in manuscript review. [ABSTRACT FROM AUTHOR]

Despite suicide ideation being one of the most frequently reported health issues impacting tertiary students, there is a paucity of research evaluating the efficacy of preventive interventions aimed at improving mental health outcomes for students studying at two tertiary institutes. The current study evaluated the efficacy of the "Talk-to-Me" Mass Open Online Course (MOOC) in improving tertiary students' abilities to support the mental health of themselves and their peers via a randomised controlled trial design, comparing them to a waitlist control group. Overall, 129 tertiary students (M = 25.22 years, SD = 7.43; 80% female) undertaking a health science or education course at two Western Australian universities were randomly allocated to either "Talk-to-Me" (n = 66) or waitlist control (n = 63) groups. The participants' responses to suicidal statements (primary outcome), knowledge of mental health, generalised self-efficacy, coping skills, and overall utility of the program (secondary outcomes) were collected at three timepoints (baseline 10-weeks and 24-weeks from baseline). Assessment time and group interaction were explored using a random-effects regression model, examining changes in the primary and secondary outcomes. Intention-to-treat analysis (N = 129) at 10-weeks demonstrated a significant improvement in generalised self-efficacy for "Talk-to-Me" compared to the control group (ES = 0.36, p =.04), with only the "Talk-to-Me" participants reporting increased knowledge in responding to suicidal ideation (primary outcome). This change was sustained for 24 weeks. Findings provide preliminary evidence suggesting that the "Talk-to-Me" MOOC can effectively improve tertiary students' mental health and knowledge of how to support themselves and others in distress. ACTRN12619000630112, registered 18-03-2019, anzctr.org.au. [ABSTRACT FROM AUTHOR]

Background: Given that high levels of stress during adolescence are associated with negative consequences, it is important that adolescents with psychological needs are supported at an early stage, for instance with interventions at school. However, knowledge about the potential of school-based programs targeting adolescents with psychological needs, aimed at reducing school or social stress, is lacking. Objective: The current study aimed to investigate the effectiveness of two targeted school-based skills-training programs, addressing either skills to deal with performance anxiety or social skills. Methods: Two randomized controlled trials were performed with participants who self-selected to one of the programs. The sample comprised of N = 361 adolescents (Mage = 13.99 years, SD = 0.83) from various educational levels and ethnic identity backgrounds. The performance anxiety program included N = 196 participants (N = 95 in the experimental group), while the social skills program included N = 165 participants (N = 86 in the experimental group). MANCOVA's were performed. Results: The performance anxiety program had a small effect on reducing adolescents' test anxiety. Furthermore, for adolescents who attended more than half of the sessions, the program had small effects on reducing test anxiety and fear of failure. The program did not improve adolescents' coping skills or mental health. The social skills program was not effective in improving social skills, social anxiety, and mental health. Conclusions: A relatively short, targeted program addressing skills to deal with performance anxiety can have the potential to reduce adolescents' performance anxiety. Trial registration: International Clinical Trials Registry Platform (Netherlands Trial Register, number NTR7680). Registered 12 December 2018. Study protocol van Loon et al., (2019). [ABSTRACT FROM AUTHOR]

Objective: Smoking cessation for individuals with Chronic Obstructive Pulmonary Disease (COPD) is medically critical, but smoking for coping motives is a common barrier. Method: In this evaluation of three treatment components (Mindfulness, Practice Quitting, and Countering Emotional Behaviors), we conducted two studies guided by the ORBIT model. Study 1 was a single-case design experiment (N = 18); Study 2 was a pilot feasibility study (N = 30). In both studies, participants were randomized to receive one of the three treatment modules. Study 1 examined implementation targets, changes in smoking for coping motives, and changes in smoking rate. Study 2 examined overall feasibility and participant-rated acceptability, and changes in smoking rate. Results: Study 1: Treatment implementation targets were met by 3/5 Mindfulness participants, 2/4 Practice Quitting participants, and 0/6 Countering Emotional Behaviors participants. The Practice Quitting condition led to 100% of participants meeting the clinically significant threshold in smoking for coping motives. Incidence of quit attempts ranged from 0–50%, and smoking rate was reduced by 50% overall. Study 2: Recruitment and retention met feasibility targets, with 97% of participants completing all four treatment sessions. Participants reported high treatment satisfaction by qualitative responses and rating scales (M = 4.8/ 5.0). Incidence of quit attempts ranged from 25–58%, and smoking rate was reduced by 56% overall. Conclusions: These two small-N studies provide complementary findings on internal validity and implementation of the novel intervention. While Study 1 provided initial support for plausibility of clinically significant change, Study 2 provided data on key feasibility parameters. Implications: Smoking cessation for individuals with COPD is medically critical. We conducted an early-phase evaluation of a novel behavioral treatment focused on reducing smoking for coping motives. Results provided initial support for plausibility of clinically significant change and feasibility of the intervention. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic had a significant impact on vulnerable populations, including people living with HIV. California implemented a coronavirus lockdown (stay-at-home order) in March 2020, which ended in January 2021. We evaluated the pandemic's impact on both clinical outcomes of HIV RNA viral load (VL) and retention rate in a randomized clinical trial conducted from May 2018 to October 2020. The intervention group took co-encapsulated antiretrovirals (ARVs) with ingestible sensor (IS) pills from baseline through week 16. The IS system has the capacity to monitor adherence in real-time using a sensor patch, a mobile device, and supporting software. Both the IS and usual care (UC) groups were followed monthly for 28 weeks. Longitudinal mixed-effects models with random intercept and slope (RIAS) were used to fit log VL and self-reported adherence. The sample size of the study was 112 (54 in IS). Overall, the retention rate at week 28 was 86%, with 90% before the lockdown and 83% after the lockdown. The lockdown strengthened the associations between adherence and VL. Before the lockdown, a 10% increase in adherence was associated with a 0.2 unit decrease in log VL (β = -1.88, p = 0.004), while during the lockdown, the association was a 0.41-unit decrease (β = -2.27, p = 0.03). The pandemic did not have a significant impact on our adherence-focused intervention. Our findings regarding the intervention effect remain valid. Trial Registration Number: NCT02797262. Date registration: September 2015. [ABSTRACT FROM AUTHOR]

This study examined the effectiveness of a theory-based mHealth intervention on the quality of life (QOL) of people living with HIV. A randomized controlled trial was performed at two outpatient clinics in Hanoi, Vietnam. There were 428 patients with HIV/AIDs in selected clinics and were divided into the intervention arm (receiving HIV-assisted smartphone application and usual care) and the control arm (receiving only usual care). The WHOQOLHIV-BREF instrument was utilized to measure QOL. An intention-to-treat approach using Generalized Linear Mixed Model analysis was performed. The trial showed significant improvements in Physical health, Psychological health, and Level of Dependence among patients in the intervention arm compared to the control arm. However, the Environment and Spirituality/Personal beliefs improvements would require additional interventions, both individual, organizational, or governmental. This study explored the utility of a smartphone mobile application for individuals with HIV, and how the resultant application could improve the overall QOL. [ABSTRACT FROM AUTHOR]

Background: A common method of pain assessment is the numerical rating scale, where patients are asked to rate their pain on a scale from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine". We hypothesize such language is suboptimal as it involves a test of a cognitive skill, imagination, in the assessment of symptom severity. Methods: We used a large-scale online research registry, ResearchMatch, to conduct a randomized controlled trial to compare the distributions of pain scores of two different pain scale anchors. We recruited adults located in the United States who reported a chronic pain problem (> 3 months) and were currently in pain. Participants were randomized in a 1:1 ratio to receive pain assessment based on a modified Brief Pain Inventory (BPI), where the anchor for a score of 10 was either "extremely severe pain", or the original BPI, with the anchor "pain as bad as you can imagine". Participants in both groups also answered additional questions about pain, other symptomatology and creativity. Results: Data were obtained from 405 participants for the modified and 424 for the original BPI. Distribution of responses to pain questions were similar between groups (all p-values ≥ 0.12). We did not see evidence that the relationship between pain score and the anchor text differed based on self-perceived creativity (all interaction p-values ≥ 0.2). However, in the key analysis, correlations between current pain assessments and known correlates (fatigue, anxiety, depression, current pain compared to a typical day, pain compared to other people) were stronger for "extreme" vs. "imaginable" anchor text (p = 0.005). Conclusion: Pain rating scales should utilize the modified anchor text "extremely severe pain" instead of "pain as bad as you can imagine". Further research should explore the effects of anchors for other symptoms. [ABSTRACT FROM AUTHOR]

Background: Eptinezumab demonstrated efficacy in adults with migraine and prior preventive treatment failures in the placebo-controlled phase of the DELIVER clinical trial; its long-term effectiveness in this population has not yet been reported. The objective of this study was to evaluate the long-term effectiveness of eptinezumab in a migraine patient population during the 48-week extension phase of DELIVER. Methods: DELIVER was conducted June 1, 2020 to September 15, 2022. 865 adults with migraine, with documented evidence of 2–4 prior preventive migraine treatment failures and with completion of the 24-week placebo-controlled period of DELIVER received eptinezumab (100 or 300 mg) during the dose-blinded extension, either continuing their randomized dose or, if originally receiving placebo, were randomized 1:1 to an eptinezumab dose (100 or 300 mg). A mixed model for repeated measures was used to evaluate changes from baseline in the number of monthly migraine days (MMDs). Results: Of 865 patients entering the extension (eptinezumab 100 mg, n = 433; 300 mg, n = 432), 782 (90.4%) completed and 11 (1.3%) discontinued due to an adverse event. Eptinezumab was associated with early and sustained reductions in migraine frequency. Mean MMDs at baseline were approximately 14 days across groups. Mean (standard error) change from baseline in MMDs over the final dosing interval (weeks 61–72) was −6.4 (0.50) with placebo/eptinezumab 100 mg, –7.3 (0.49) with placebo/eptinezumab 300 mg, –7.1 (0.39) with eptinezumab 100 mg, and −7.0 (0.39) with eptinezumab 300 mg. During weeks 61–72, 63–70% of patients demonstrated ≥ 50% reduction in MMDs, and 36–45% demonstrated ≥ 75% reduction. Headache severity and acute medication use reductions, and patient-reported improvements in most bothersome symptom, disease status, quality of life, and work productivity, were observed. Adverse events were generally mild, transient, and similar in frequency/type to previous eptinezumab trials. Conclusions: The long-term effectiveness and safety/tolerability of eptinezumab in patients with migraine and 2–4 prior preventive treatment failures was demonstrated by high completion rates and migraine-preventive benefits sustained for up to 18 months, implying that eptinezumab is a viable long-term treatment option for patients still seeking successful migraine treatments. Trial registration: ClinicalTrials.gov (Identifier: NCT04418765; URL: https://www.clinicaltrials.gov/ct2/show/NCT04418765); EudraCT (Identifier: 2019-004497-25; URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004497-25). [ABSTRACT FROM AUTHOR]

Differences in audiovisual integration are commonly observed in autism. Temporal binding windows (TBWs) of audiovisual speech can be trained (i.e., narrowed) in non-autistic adults; this study evaluated a computer-based perceptual training in autistic youth and assessed whether treatment outcomes varied according to individual characteristics. Thirty autistic youth aged 8–21 were randomly assigned to a brief perceptual training (n = 15) or a control condition (n = 15). At post-test, the perceptual training group did not differ, on average, on TBWs for trained and untrained stimuli and perception of the McGurk illusion compared to the control group. The training benefited youth with higher language and nonverbal IQ scores; the training caused widened TBWs in youth with co-occurring cognitive and language impairments. [ABSTRACT FROM AUTHOR]

Introduction: Perinatal depression is common among women living with HIV, but depression care is limited in low-resource settings. We examined (1) characteristics of women receiving Problem Solving Therapy (PST) versus antidepressant therapy (ADT), (2) treatment response by modality, and (3) correlates of treatment response. Methods: This analysis used data from 191 Ugandan women in the intervention arm of a cluster randomized controlled trial of task-shifted, stepped-care depression treatment for pregnant women living with HIV (PWLWH). Treatment response was defined as scoring < 5 on the nine-item Patient Health Questionnaire (PHQ-9). Bivariate analysis and multivariable logistic regression were used to examine characteristics of women by treatment group and correlates of treatment response. Results: Of 134 participants with depression, 129 (96%) were treated: 84 (65%) received PST and 45 (35%) received ADT. Severe depression at treatment initiation was more common in those receiving ADT (28.9% versus 4.8%, Fischer's Exact Test < 0.001). Treatment response was higher for PST (70/84; 83.3%) than ADT (30/45; 66.7%; p =.03). ADT side effects were rare and minor; no infants had serious congenital defects. Of 22 participants (19%) who did not respond to treatment, only five received intensified management. Social support and interpersonal violence were associated with treatment response (adjusted odds ratio, [aOR] = 3.06, 95% CI = 1.08–8.66 and aOR = 0.64, 95% CI = 0.44–0.93). Discussion: Both depression treatment modalities yielded high response rates in Ugandan PWLWH; ADT was well-tolerated. Our results highlight a need to build capacity to implement the stepped-care protocol for non-responders and screen for social support and interpersonal violence. Significance: What is Already Known on this Subject?Prior research has demonstrated the feasibility and effectiveness of delivering collaborative care for depression in low-resource settings including Uganda. What this Study adds?Both Problem-Solving Therapy and antidepressant therapy yielded high treatment response rates among pregnant women living with HIV in Uganda who met criteria for depression, and antidepressant therapy was well tolerated. This study highlights a need to build capacity to implement the task-shifted stepped-care protocol for women whose depression does not respond to initial treatment, and to screen for social support and interpersonal violence. [ABSTRACT FROM AUTHOR]

Copyright of AIDS & Behavior is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

For most youth with autism spectrum disorders (ASD), employment upon graduation from high school or college is elusive. Employment rates are reported in many studies to be very low despite many years of intensive special education services. This paper presented the preliminary results of a randomized clinical trial of Project SEARCH plus ASD Supports on the employment outcomes for youth with ASD between the ages of 18-21 years of age. This model provides very promising results in that the employment outcomes for youth in the treatment group were much higher in non-traditional jobs with higher than minimum wage incomes than for youth in the control condition. Specifically, 21 out of 24 (87.5 %) treatment group participants acquired employment while 1 of 16 (6.25 %) of control group participants acquired employment. [ABSTRACT FROM AUTHOR]

Summary: We have developed a short, patient-reported outcome questionnaire-the Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF)-that assesses the impact of osteoporosis on physical function. OPAQ-PF contains 15 items in three domains (mobility, physical positions, and transfers) and has content validity in osteoporosis patients with and without a history of fracture. Introduction: This paper describes the development of the Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF), a patient-reported outcome (PRO) questionnaire based on OPAQ v.2.0 (60 items, 14 domains) that assesses the impact of osteoporosis on physical function. Methods: OPAQ v.2.0 was administered to patients with osteoporosis. Item response theory methodology and clinical judgment were used to retain/eliminate items. The resulting instrument was modified during two sets of concept elicitation and cognitive debriefing interviews with osteoporosis patients. Results: Item response theory-based analysis of OPAQ v.2.0 ( n = 1,478) coupled with clinician input resulted in the generation of a 21-item, six-domain instrument with a frequency response format. Interview data from 32 participants were used to modify this version and led to generation of the final instrument, OPAQ-PF. This final version has a severity response format and contains 15 items in three domains (mobility, physical positions, and transfers) that group together to provide an overall assessment of physical function in patients with osteoporosis. Twenty-two of the 32 interview participants (69 %) had previously sustained a fracture. Symptoms occurred primarily in these patients. Conclusions: OPAQ-PF represents a brief, focused, PRO instrument that assesses physical function in patients with osteoporosis, specifically related to mobility, physical positions, and transfers. This questionnaire has content validity in osteoporosis patients who have, and have not, sustained a prior fracture. [ABSTRACT FROM AUTHOR]

Childhood sexual and physical abuse have been linked to adolescent and adult risky sexual behaviors, including early sexual debut, an increased number of sexual partners, unprotected sex, alcohol and drug use during sex and sexual violence. This paper explores these relationships among both men and women who report histories of childhood abuse from representative samples of communities in three countries in southern and eastern Africa (South Africa, Zimbabwe and Tanzania). Data were collected as part of a 3-year randomized community trial to rapidly increase knowledge of HIV status and to promote community responses through mobilisation, mobile testing, provision of same-day HIV test results and post-test support for HIV. The results indicate that reported childhood sexual and physical abuse is high in all three settings, also among men, and shows strong relationships with a range of sexual risk behaviors, including age at first sex (OR −0.6 (CI: −0.9, −0.4, p < 0.003)-among men, OR −0.7 (CI: −0.9, −0.5, p < 0.001)-among women), alcohol (OR 1.43 (CI: 1.22, 1.68, p < 0.001)-men, OR 1.83 (CI: 1.50, 2.24, p < 0.001)-women) and drug use (OR 1.65 (CI: 1.38, 1.97, p < 0.001)-men, OR 3.14 (CI: 1.95, 5.05, p < 0.001)-women) and two forms of partner violence-recent forced sex (OR 2.22 (CI: 1.66, 2.95, p < 0.001)-men, OR 2.76 (CI: 2.09, 3.64, p < 0.001)-women) and ever being hurt by a partner (OR 3.88 (CI: 2.84, 5.29, p < 0.001)-men, OR 3.06 (CI: 2.48, 3.76, p < 0.001)-women). Individuals abused in childhood comprise between 6 and 29 % of young adult men and women living in these African settings and constitute a population at high risk of HIV infection. [ABSTRACT FROM AUTHOR]

This paper examines prevalence rates of HIV, HCV, and syphilis among a sample of injecting drug users (IDUs) and their heterosexual intimate partners ( N = 728) from Almaty, Kazakhstan. The study uses baseline data from Project Renaissance, a couple-based HIV prevention intervention delivered to a couple where one or both partners are IDUs. HIV prevalence rates among female and male IDUs were 28 %. Among the full sample, 75 % had HCV, and 13 % tested positive for the syphilis antibody test. Only 10 % of the sample ever visited a needle exchange program. One-fourth (25.3 %) had never been tested for HIV. One-quarter of those who tested positive were unaware of their status. Being HIV positive was associated with a history of incarceration, being an IDU, and having access to needle exchange programs. The findings call for increasing efforts to improve access to HIV testing, prevention, treatment, and care for IDUs in Almaty, Kazakhstan. [ABSTRACT FROM AUTHOR]

This paper used qualitative methods to explore experiences of men who have sex with men and female sex workers in Nairobi and Mtwapa, Kenya, who used oral pre-exposure prophylaxis (PrEP) for HIV prevention as part of a four-month trial of safety, acceptability and adherence. Fifty-one of 72 volunteers who took part in a randomized, placebo-controlled, blinded trial that compared daily and intermittent dosage of PrEP underwent qualitative assessments after completing the trial. Analyses identified three themes: (i) acceptability of PrEP was high, i.e. side effects were experienced early in the study but diminished over time, however characteristics of pills could improve comfort and use; (ii) social impacts such as stigma, rumors, and relationship difficulties due to being perceived as HIV positive were prevalent; (iii) adherence was challenged by complexities of daily life, in particular post-coital dosing adherence suffered from alcohol use around time of sex, mobile populations, and transactional sex work. These themes resonated across dosing regimens and gender, and while most participants favored the intermittent dosing schedule, those in the intermittent group noted particular challenges in adhering to the post-coital dose. Culturally appropriate and consistent counseling addressing these issues may be critical for PrEP effectiveness. [ABSTRACT FROM AUTHOR]

A transdisciplinary approach incorporating biological, psychological, behavioral, and genetic factors was taken to better identify proposed moderators of the effectiveness of an intervention to increase physical activity. This paper illustrates how theory-based individual difference variables can be integrated into a complex randomized controlled trial. The transdisciplinary framework guiding the selection of moderators, the COSTRIDE intervention study and sample, and the relationships among baseline variables are provided. Participants were non-active individuals randomly assigned to either the STRIDE exercise or health-and-wellness contact control condition. Structural equation modeling was utilized to demonstrate that relationships among baseline variables confirm hypothesized relationships in the transdisciplinary framework. Preliminary data from COSTRIDE suggest that interventions among sedentary individuals may be more effective if a broader range of factors influencing physical activity are considered. [ABSTRACT FROM AUTHOR]

Health and social disparities are widespread among men who have sex with men (MSM). Although literature indicates that Black MSM (BMSM) are no more likely than other MSM to report sexual risk behaviors, such as unprotected anal intercourse, studies have reported that buying and trading sex appear to be important risk factors for BMSM. Substance use generally is not significantly greater among BMSM than other MSM, studies have found that BMSM report more powder and crack cocaine use than other MSM. The lack of adequate coping skills and social support for BMSM has also been documented. This paper examines differences in substance use, sexual risk behaviors and social support among Black and non-black MSM, in a sample of 515 men participating in a randomized intervention trial. BMSM reported higher rates of substance dependence (72.2 vs. 59.5 %, P = .015) and buying sex (49.1 vs. 17.4 %, P < .000) than non-Black MSM. BMSM also reported lower levels of social support than other MSM on all measures included in the study; e.g., getting help and emotional support from others (38.0 vs. 52.8 %, P < .006). Mediation analyses showed that BMSM's higher rates of substance dependence and buying sex are partially mediated by lower levels of social support. Our data appear to show that lack of social support is an important influence on risk behaviors among BMSM. Qualitative data also supported these findings. Sexual risk and substance use prevention interventions should address BMSM's capacity to build adequate and supportive relationships. [ABSTRACT FROM AUTHOR]

The negative impacts of parental mental health problems on children and adolescents are well known, but the relationship between a child's depression and their parents' health is not so well understood. Being a carer/parent of someone with mental illness can be associated with negative outcomes for the caregiver. This paper reports the associations between the mental health of adolescents with major depression and their parents, before and after treatment of the adolescent's depression. Data were collected as part of the Adolescent Depression Antidepressants and Psychotherapy Trial, a randomised controlled trial of selective serotonin reuptake inhibitors with and without cognitive behaviour therapy in 208 clinic-recruited adolescents with major depression. The baseline severity of depression in the adolescent was significantly associated with both maternal and paternal mental health (as rated by the General Health Questionnaire). This effect was not confounded by other psychiatric symptoms. The degree of improvement in parental and child mental health was positively correlated across time. Our results support the hypothesis that there is a significant association between parental mental health and adolescent depressive symptoms. This study was not able to establish the direction of this association. In clinical practice, the findings demonstrate the importance of considering the mental health of the parents when treating depressed adolescents. [ABSTRACT FROM AUTHOR]

We conducted a 2-year pilot randomized controlled trial (N = 105) in a high HIV-prevalence area in rural western Kenya to test whether providing young orphan adolescents with uniforms, school fees, and community visitors improves school retention and reduces HIV risk factors. The trial was a community intervention, limited to one community. In this paper, we examined intervention implementation and its association with outcomes using longitudinal data. We used both quantitative and qualitative methods to evaluate the community-based model for orphan HIV prevention, with recommendations for future studies. Despite promising effects after 1 year, GEE analyses showed null effects after 2 years. Volunteer community visitors, a key element of the intervention, showed little of the expected effect although qualitative reports documented active assistance to prevent orphans' school absence. For future research, we recommend capturing the transition to high school, a larger sample size, and biomarker data to add strength to the research design. We also recommend a school-based intervention approach to improve implementation and reduce infrastructure costs. Finally, we recommend evaluating nurses as agents for improving school attendance and preventing dropout because of their unique ability to address critical biopsychosocial problems. [ABSTRACT FROM AUTHOR]

To address the unmet need for scalable solutions for lifestyle treatment, we developed a new digital method to promote behavioral change. Here we report that patients with type-2 diabetes in Sweden (n = 331) exposed to the intervention have significantly improved HbA1c during a median follow-up of 1038 days (4 mmol/mol compared with matched controls; P = 0.009). This is paralleled by reduced body weight, ameliorated insulin secretion, increased physical activity, and cognitive eating restraints. Participants with high BMI and insulin resistance have an even larger response, as have non-risk allele carriers for the FTO gene. The findings open a new avenue for scalable lifestyle management with sustained efficacy and highlight a previously unrecognized opportunity for digital precision treatment based on genetics and individual pathophysiology. ClinicalTrials.gov NCT04624321. [ABSTRACT FROM AUTHOR]

Congenital malformations of the central nervous system are among the most common major congenital malformations. Deep learning systems have come to the fore in prenatal diagnosis of congenital malformation, but the impact of deep learning-assisted detection of congenital intracranial malformations from fetal neurosonographic images has not been evaluated. Here we report a three-way crossover, randomized control trial (Trial Registration: ChiCTR2100048233) that assesses the efficacy of a deep learning system, the Prenatal Ultrasound Diagnosis Artificial Intelligence Conduct System (PAICS), in assisting fetal intracranial malformation detection. A total of 709 fetal neurosonographic images/videos are read interactively by 36 sonologists of different expertise levels in three reading modes: unassisted mode (without PAICS assistance), concurrent mode (using PAICS at the beginning of the assessment) and second mode (using PAICS after a fully unaided interpretation). Aided by PAICS, the average accuracy of the unassisted mode (73%) is increased by the concurrent mode (80%; P < 0.001) and the second mode (82%; P < 0.001). Correspondingly, the AUC is increased from 0.85 to 0.89 and to 0.90, respectively (P < 0.001 for all). The median read time per data is slightly increased in concurrent mode but substantially prolonged in the second mode, from 6 s to 7 s and to 11 s (P < 0.001 for all). In conclusion, PAICS in both concurrent and second modes has the potential to improve sonologists' performance in detecting fetal intracranial malformations from neurosonographic data. PAICS is more efficient when used concurrently for all readers. [ABSTRACT FROM AUTHOR]

Purpose: Allulose is a rare monosaccharide with almost zero calories. There is no study of short-term allulose consumption in patients with type 2 diabetes (T2D). Thus, we aimed to study the effect of allulose consumption for 12 weeks on glucose homeostasis, lipid profile, body composition, incretin levels, and inflammatory markers in patients with T2D. Methods: A double-blind, randomized, controlled crossover study was conducted on sixteen patients with T2D. Patients were randomly assigned to allulose 7 g twice daily or aspartame 0.03 g twice daily for 12 weeks. After a 2-week washout, patients were crossed over to the other sweetener for an additional 12 weeks. Oral glucose tolerance tests, laboratory measurements, and dual-energy X-ray absorptiometry were conducted before and after each phase. Results: This study revealed that short-term allulose consumption exerted no significant effect on glucose homeostasis, incretin levels, or body composition but significantly increased MCP-1 levels (259 ± 101 pg/ml at baseline vs. 297 ± 108 pg/mL after 12 weeks of allulose, p = 0.002). High-density lipoprotein cholesterol (HDL-C) significantly decreased from 51 ± 13 mg/dl at baseline to 41 ± 12 mg/dL after 12 weeks of allulose, p < 0.001. Conclusion: Twelve weeks of allulose consumption had a neutral effect on glucose homeostasis, body composition, and incretin levels. Additionally, it decreased HDL-C levels and increased MCP-1 levels. Trial registration: This trial was retrospectively registered on the Thai Clinical Trials Registry (TCTR20220516006) on December 5, 2022. [ABSTRACT FROM AUTHOR]

Purpose: Adherence to the Mediterranean diet is associated with beneficial health effects, including gastrointestinal disorders. Preclinical studies suggest that omega-3 polyunsaturated fatty acids (n-3 PUFAs), found in Mediterranean foods like nuts and fish, improve intestinal barrier integrity. Here, we assessed possible effects of n-3 PUFAs on barrier integrity in a randomized controlled trial. Methods: We studied 68 women from the open-label LIBRE trial (clinicaltrials.gov: NCT02087592) who followed either a Mediterranean diet (intervention group, IG) or a standard diet (control group, CG). Study visits comprised baseline, month 3, and month 12. Barrier integrity was assessed by plasma lipopolysaccharide binding protein (LBP) and fecal zonulin; fatty acids by gas chromatography with mass spectrometry. Median and interquartile ranges are shown. Results: Adherence to the Mediterranean diet increased the proportion of the n-3 docosahexaenoic acid (DHA) (IG + 1.5% [0.9;2.5, p < 0.001]/ + 0.3% [− 0.1;0.9, p < 0.050] after 3/12 months; CG + 0.9% [0.5;1.6, p < 0.001]/ ± 0%) and decreased plasma LBP (IG − 0.3 µg/ml [− 0.6;0.1, p < 0.010]/ − 0.3 µg/ml [− 1.1; − 0.1, p < 0.001]; CG − 0.2 µg/ml [− 0.8; − 0.1, p < 0.001]/ ± 0 µg/ml) and fecal zonulin levels (IG − 76 ng/mg [− 164; − 12, p < 0.010]/ − 74 ng/mg [− 197;15, p < 0.001]; CG − 59 ng/mg [− 186;15, p < 0.050]/ + 10 ng/mg [− 117;24, p > 0.050]). Plasma DHA and LBP (R2: 0.14–0.42; all p < 0.070), as well as plasma DHA and fecal zonulin (R2: 0.18–0.48; all p < 0.050) were found to be inversely associated in bi- and multivariate analyses. Further multivariate analyses showed that the effect of DHA on barrier integrity was less pronounced than the effect of fecal short-chain fatty acids on barrier integrity. Conclusions: Our data show that n-3 PUFAs can improve intestinal barrier integrity. Trial registration number: The trial was registered prospectively at ClinicalTrials.gov (reference: NCT02087592). [ABSTRACT FROM AUTHOR]