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Background: OSA is associated with metabolic syndrome (MS), but it is unclear whether OSA treatment with CPAP can revert MS.Research Question: Does OSA treatment with CPAP per se have effects on the MS reversibility and the associated metabolic, adiposity and vascular parameters?Study Design and Methods: The TREATOSA-MS trial is a randomized placebo-controlled trial that enrolled adult patients with a recent diagnosis of MS and moderate or severe OSA (apnea-hypopnea index [AHI], ≥ 15 events/h) to undergo therapeutic CPAP or nasal dilator strips (placebo group) for 6 months. Before and after each intervention, we measured anthropometric variables, BP, glucose, and lipid profile. To control potential-related mechanisms and consequences, we also measured adiposity biomarkers (leptin and adiponectin), body composition, food intake, physical activity, subcutaneous and abdominal fat (visceral and hepatic fat), and endothelial function.Results: One hundred patients (79% men; mean age, 48 ± 9 years; BMI, 33 ± 4 kg/m2; AHI, 58 ± 29 events/h) completed the study (n = 50 per group). The mean CPAP adherence was 5.5 ± 1.5 h/night. After 6 months, most patients with OSA randomized to CPAP retained the MS diagnosis, but the rate of MS reversibility was higher than observed in the placebo group (18% vs 4%; OR, 5.27; 95% CI, 1.27-35.86; P = .04). In the secondary analysis, CPAP did not promote significant reductions in the individual components of MS, weight, hepatic steatosis, lipid profile, adiponectin, and leptin, but did promote a very modest reduction in visceral fat and improved endothelial function (all analyses were adjusted for baseline values).Interpretation: Despite the higher rate of MS reversibility after CPAP therapy as compared with placebo, most patients retained this diagnosis. The lack of significant or relevant effects on adiposity biomarkers and depots supports the modest role of OSA in modulating MS.Trial Registration: ClinicalTrials.gov; No.: NCT02295202; URL: www.Clinicaltrials: gov. [ABSTRACT FROM AUTHOR]

Background: Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated VTE.Research Question: Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE?Study Design and Methods: In a randomized open-label noninferiority trial, patients with active cancer who had proximal DVT, pulmonary embolism (PE), or both were assigned randomly to therapeutic doses of rivaroxaban or dalteparin for 3 months. The primary outcome was the cumulative incidence of recurrent VTE, a composite of symptomatic or incidental DVT or PE, and worsening of pulmonary vascular or venous obstruction at 3 months.Results: Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, and 115 patients (76.2%) had metastatic disease. The primary outcome occurred in 4 and 6 patients in the rivaroxaban and dalteparin groups, respectively (both the intention-to-treat and per-protocol populations: cumulative incidence, 6.4% vs 10.1%; subdistribution hazard ratio [SHR], 0.75; 95% CI, 0.21-2.66). Major bleeding occurred in 1 and 3 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 1.4% vs 3.7%; SHR, 0.36; 95% CI, 0.04-3.43). Major or clinically relevant nonmajor bleeding occurred in 9 and 8 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 12.2% vs 9.8%; SHR, 1.27; 95% CI, 0.49-3.26). Overall, 19 patients (25.7%) and 20 patients (23.8%) died in the rivaroxaban and dalteparin groups, respectively (hazard ratio, 1.05; 95% CI, 0.56-1.97).Interpretation: In this trial comparing rivaroxaban and dalteparin in the treatment of cancer-associated VTE, the number of patients was insufficient to reach the predefined criteria for noninferiority, but efficacy and safety results were consistent with those previously reported with DOACs. An updated meta-analysis of randomized trials comparing DOACs with low-molecular-weight heparin in patients with cancer-associated VTE is provided.Trial Registry: ClinicalTrials.gov; No.: NCT02746185; URL: www.Clinicaltrials: gov. [ABSTRACT FROM AUTHOR]

Objectives: Use of Motivational Interviewing (MI) in education may improve medication-overuse headache (MOH) patients' ability to cope with pain. In a randomised controlled trial, we evaluated the effect of education focusing on behavioural change among MOH patients.Methods: Ninety-eight MOH patients were randomized (1:1) to standard treatment and 12-weeks of MI-based education versus standard treatment alone after detoxification. Outcome of interest was changes in coping strategies measured by the Coping Strategy Questionnaire at four- and nine months.Results: The educational program improved patients' perceived efficacy in the use of their coping strategies to control pain, both at four-and nine months follow-up (mean±SE): ∆:0.84 ± 0.35, 95% CI:0.16;1.52, p = 0.02 and: ∆: 0.90 ± 0.39, 95% CI:0.14;1.66, p = 0.02, respectively. No between-group differences were detected in the other coping subscales. Within the intervention group, the coping strategy subscales Catastrophizing, and Reinterpretation of pain sensation were significantly improved at nine months follow-up (p = 0.003 vs. p = 0.012, respectively). No changes were found in the control group.Conclusion: MI-based education focused on behavioural changes improved MOH patients' perceived efficacy in the use of their coping strategies to control pain.Practice Implications: Education based on MI could be valuable for MOH patients with respect to behavioural changes and perceived headache control. [ABSTRACT FROM AUTHOR]

Rationale: Laryngeal edema is a known complication of endotracheal intubation that may cause airway obstruction upon extubation. The only test available to predict this complication is the cuff leak test (CLT). Objectives: Given the uncertainty of the CLT's clinical utility, we conducted the COMIC (Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients) pilot study to examine the feasibility of undertaking a larger trial. Methods: COMIC is a multicentered, parallel-group randomized trial performed in Canada, Saudi Arabia, and Poland. We enrolled mechanically ventilated adults admitted to the intensive care unit who were deemed ready for extubation. Those allocated to the intervention arm had the results of their CLT communicated to the healthcare team, who then decided to proceed with extubation or not. In those randomized to the control arm, the CLT results were not communicated to the healthcare team and patients were extubated, regardless of the CLT result. The primary outcomes focused on feasibility. Results: One hundred patients (56 in the intervention and 44 in the control arm) were enrolled. All feasibility criteria were met, including 1) recruitment rate of 7.6 patients/month, 2) consent rate of 88.3% (95% confidence interval [CI], 82.1-94.5%), and 3) protocol adherence of 98% (95% CI, 95-100%). There were two episodes of clinically significant stridor in the intervention group and four patients who required reintubation in each group. Conclusions: The results of the COMIC pilot trial support the feasibility of a larger trial to determine the effect of the CLT on reintubation and clinically important stridor.Clinical trial registered with www.clinicaltrials.gov (NCT03372707). [ABSTRACT FROM AUTHOR]

Objective: Youth with sickle cell disease (SCD) are at risk for neurocognitive deficits including problems with working memory (WM), but few interventions to improve functioning exist. This study sought to determine the feasibility and efficacy of home-based, digital WM training on short-term memory and WM, behavioral outcomes, and academic fluency using a parallel group randomized controlled trial design.Methods: 47 children (7-16 years) with SCD and short-term memory or WM difficulties were randomized to Cogmed Working Memory Training at home on a tablet device (N = 24) or to a standard care Waitlist group (N = 23) that used Cogmed after the waiting period. Primary outcomes assessed in clinic included performance on verbal and nonverbal short-term memory and WM tasks. Secondary outcomes included parent-rated executive functioning and tests of math and reading fluency.Results: In the evaluable sample, the Cogmed group (N = 21) showed greater improvement in visual WM compared with the Waitlist group (N = 22; p = .03, d = 0.70 [CI95 = 0.08, 1.31]). When examining a combined sample of participants, those who completed ≥10 training sessions exhibited significant improvements in verbal short-term memory, visual WM, and math fluency. Adherence to Cogmed was lower than expected (M = 9.07 sessions, SD = 7.77), with 19 participants (41%) completing at least 10 sessions. Conclusions: Visual WM, an ability commonly affected by SCD, is modifiable with cognitive training. Benefits extended to verbal short-term memory and math fluency when patients completed a sufficient training dose. Additional research is needed to identify ideal candidates for training and determine whether training gains are sustainable and generalize to real-world outcomes. [ABSTRACT FROM AUTHOR]

Objective: Unintentional injuries are the leading cause of death for children under 19 years of age. For preschoolers, many injuries occur in the home. Addressing this issue, this study assessed if a storybook about home safety could be effective to increase preschoolers' safety knowledge and reduce their injury-risk behaviors.Methods: Applying a randomized controlled trial design, normally developing English speaking preschool children (3.5-5.5 years) in Southwestern Ontario Canada were randomly assigned to the control condition (a storybook about healthy eating, N = 30) or the intervention condition (a storybook about home hazards, N = 29). They read the assigned storybook with their mother for 4 weeks; time spent reading was tracked, and fidelity checks based on home visits were implemented.Results: Comparing postintervention knowledge, understanding score, and risk behaviors across groups revealed that children who received the intervention were able to identify more hazards, provide more comprehensive safety explanations, and demonstrate fewer risky behaviors compared with children in the control group (ηp2 = 0.13, 0.19, and 0.51, respectively), who showed no significant changes over time in safety knowledge, understanding, or risk behaviors. Compliance with reading the safety book and fidelity in how they did so were very good.Conclusions: A storybook can be an effective resource for educating young children about home safety and reducing their hazard-directed risk behaviors. [ABSTRACT FROM AUTHOR]

Clinical practice guidelines support cognitive rehabilitation for people with a history of mild traumatic brain injury (mTBI) and cognitive impairment, but no class I randomized clinical trials have evaluated the efficacy of self-administered computerized cognitive training. The goal of this study was to evaluate the efficacy of a self-administered computerized plasticity-based cognitive training programmes in primarily military/veteran participants with a history of mTBI and cognitive impairment. A multisite randomized double-blind clinical trial of a behavioural intervention with an active control was conducted from September 2013 to February 2017 including assessments at baseline, post-training, and after a 3-month follow-up period. Participants self-administered cognitive training (experimental and active control) programmes at home, remotely supervised by a healthcare coach, with an intended training schedule of 5 days per week, 1 h per day, for 13 weeks. Participants (149 contacted, 83 intent-to-treat) were confirmed to have a history of mTBI (mean of 7.2 years post-injury) through medical history/clinician interview and persistent cognitive impairment through neuropsychological testing and/or quantitative participant reported measure. The experimental intervention was a brain plasticity-based computerized cognitive training programme targeting speed/accuracy of information processing, and the active control was composed of computer games. The primary cognitive function measure was a composite of nine standardized neuropsychological assessments, and the primary directly observed functional measure a timed instrumental activities of daily living assessment. Secondary outcome measures included participant-reported assessments of cognitive and mental health. The treatment group showed an improvement in the composite cognitive measure significantly larger than that of the active control group at both the post-training [+6.9 points, confidence interval (CI) +1.0 to +12.7, P = 0.025, d = 0.555] and the follow-up visit (+7.4 points, CI +0.6 to +14.3, P = 0.039, d = 0.591). Both large and small cognitive function improvements were seen twice as frequently in the treatment group than in the active control group. No significant between-group effects were seen on other measures, including the directly-observed functional and symptom measures. Statistically equivalent improvements in both groups were seen in depressive and cognitive symptoms. [ABSTRACT FROM AUTHOR]

Background: Target lesion failure remains an issue with contemporary drug-eluting stents. Thus, the dual-therapy sirolimus-eluting and CD34+ antibody-coated Combo stent (DTS) was designed to further improve early healing. This study aimed to investigate whether the DTS is noninferior to the sirolimus-eluting Orsiro stent (SES) in an all-comers patient population.Methods: The SORT OUT X (Combo Stent Versus Orsiro Stent) trial, was a large-scale, randomized, multicenter, single-blind, 2-arm, noninferiority trial with registry-based follow-up. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction, or target lesion revascularization within 12 months, analyzed using intention-to-treat. The trial was powered for assessing target lesion failure noninferiority of the DTS compared with the SES with a predetermined noninferiority margin of 0.021.Results: A total of 3146 patients were randomized to treatment with the DTS (1578 patients; 2008 lesions) or SES (1568 patients; 1982 lesions). At 12 months, intention-to-treat analysis showed that 100 patients (6.3%) assigned the DTS and 58 patients (3.7%) assigned the SES met the primary end point (absolute risk difference, 2.6% [upper limit of 1-sided 95% CI, 4.1%]; P (noninferiority)=0.76). The SES was superior to the DTS (incidence rate ratios for target lesion failure, 1.74 [95% CI, 1.26-2.41]; P=0.00086). The difference was explained mainly by a higher incidence of target lesion revascularization in the DTS group compared with the SES group (53 [3.4%] vs. 24 [1.5%]; incidence rate ratio, 2.22 [95% CI, 1.37-3.61]; P=0.0012).Conclusions: The DTS did not confirm noninferiority to the SES for target lesion failure at 12 months in an all-comer population. The SES was superior to the DTS mainly because the DTS was associated with an increased risk of target lesion revascularization. However, rates of death, cardiac death, and myocardial infarction at 12 months did not differ significantly between the 2 stent groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03216733. [ABSTRACT FROM AUTHOR]

Background: This split-mouth randomized clinical trial compared two different types of subepithelial connective tissue grafts (SCTG) considering clinical parameters and patient-centered outcomes in patients with bilateral recession type 1 multiple gingival recessions after 6 months postoperatively.Methods: A total of 21 patients were surgically treated with coronally advanced flap (CAF) associated with SCTG harvested by: double blade scalpel (DBS) and de-epithelialized (DE) SCTG. Periodontal clinical parameters and esthetics were evaluated by a calibrated periodontist at baseline and after 6 months. Patient-centered outcomes related to pain/discomfort and esthetics were assessed with visual analogue scale after 7 days and 6 months, respectively.Results: All clinical parameters, with the exception of probing depth, demonstrated differences in intragroup evaluation, comparing baseline to 6-month evaluation (P <0.05). Both groups presented reduction of recession depth and recession width and gain of keratinized tissue thickness, keratinized tissue width, and clinical attachment level (P <0.05). Intergroup comparison (DBS × DE) demonstrated no significant differences considering clinical parameters and periods. Both techniques improved esthetics evaluated by patients, without a difference between groups in patients and professional analysis. However, DBS group presented inferior pain/discomfort compared with DE (P <0.05).Conclusion: DBS and DE associated with CAF presented satisfactory clinical outcomes. However, DBS presented inferior morbidity, an important fact for decision-making process. [ABSTRACT FROM AUTHOR]

Background: Few treatments are available for patients with idiopathic hypersomnia (IH). Modafinil, an established treatment for narcolepsy, was tested for efficacy and safety in Japanese patients with IH without long sleep time.Methods: This multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study was conducted at 20 institutions in Japan. Patients who met the diagnostic criteria of IH in the International Classification of Sleep Disorders (second edition) were included. The study comprised a ≥17-day observation period and a 3-week treatment period during which modafinil (200 mg) or placebo was administered orally once daily (in the morning). The primary efficacy endpoint was change in mean sleep latency on the Maintenance of Wakefulness Test (MWT). Adverse events (AEs) were also recorded to evaluate safety.Results: In total, 123 patients were screened and 71 were randomized to receive modafinil (N = 34) or placebo (N = 37). Patients treated with modafinil experienced a significantly prolonged mean sleep latency on the MWT at the end of the study compared with placebo (5.02 min, 95% confidence interval: 3.26-6.77 min; p < 0.001). AEs occurred in 58.8% (20/34) and 27.0% (10/37) of patients in the modafinil and placebo groups, respectively. Frequent AEs in the modafinil group were headache (n = 6), dry mouth (n = 3), and nausea (n = 3); no clinically significant AEs occurred.Conclusion: Modafinil was shown to be an effective and safe treatment for excessive daytime sleepiness in patients with IH without long sleep time.Clinical Trial Registration: JapicCTI; 142539. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to investigate the effectiveness of a Computer-based Cognitive Behavioral Therapy (CCBT) and identify the characteristics of depressed adolescents that participated in the CCBT program.Methods: Screening tests for depression and help-seeking variables were conducted in school-aged Korean adolescents (n= 376, mean age=15.71 years, 53.7% female). The number of adolescents that scored above the threshold for mild depression (PHQ-9, CES-D) was 139. Fifty adolescents agreed to participate in the randomized controlled trial (RCT) of CCBT program. Twenty-five adolescents were randomly assigned to the treatment group, and the other 25 to the waitlist control group. The treatment group engaged in CCBT with therapeutic support. To identify variables affecting the outcomes, the quality of their homework compliance also was assessed.Results: Participants (n=50) who agreed to participate in the CCBT program demonstrated different help-seeking attitudes - a greater recognition of the need for help and lower interpersonal openness - compared to the adolescents (n=87) who did not participate (t = -2.93, p < .01; t = 3.50, p < .001). The treatment group showed significant improvements in depression, self-esteem, and quality of life compared to the waitlist group. Adolescents with high homework compliance showed a significant decrease in the depression scores compared to adolescents with low homework compliance.Limitations: Small sample size, no follow-up assessments.Conclusion: CCBT could be an effective alternative for depressed adolescents, especially those who tend to have low interpersonal openness. To improve the effects of CCBT, therapeutic support needs to be provided. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of studying creatine in juvenile dermatomyositis (JDM). Secondary objectives were to determine the effect of creatine on muscle function and metabolism, aerobic capacity, fatigue, physical activity, and quality of life (QOL), as well as its safety.Methods: We conducted a 6-month, double-blind, randomized, multiple-baseline design; patients were assigned to creatine or placebo. Feasibility was assessed using attended study visits, completed study procedures, and adherence. Muscle function, aerobic capacity, and muscle strength were assessed with standardized exercise tests. Muscle metabolism was assessed using a 31-Phosphorus Magnetic Resonance Spectroscopy protocol. Fatigue, physical activity, and QOL were assessed by questionnaires. Statistical significance was estimated using a randomization (permutation) test. Changes in outcome measures taken at baseline and end-of-study were calculated using paired t-tests.Results: Median (range) adherence to the study drug was 88.5% (20.5-95.5%) and the proportion of subjects with 80% adherence or higher was 76.9%. There were no missed study visits. There were no statistically significant changes in muscle function, strength, aerobic capacity, disease activity, fatigue, physical activity, or QOL while subjects were receiving creatine compared to placebo. There were statistically significant adaptations in muscle metabolism (e.g., decrease in change in muscle pH following exercise, and decrease in phosphate/phosphocreatine ratio) at the end-of-study compared to baseline. There were no significant adverse effects.Conclusion: Creatine supplementation in children with JDM is feasible to study, and is safe and well-tolerated; it may lead to improvements in muscle metabolism. [ABSTRACT FROM AUTHOR]

Few comprehensive primary prevention approaches for youth have been evaluated for effects on multiple types of violence. Dating Matters®: Strategies to Promote Healthy Teen Relationships (Dating Matters) is a comprehensive teen dating violence (TDV) prevention model designed by the Centers for Disease Control and Prevention and evaluated using a longitudinal stratified cluster-randomized controlled trial to determine effectiveness for preventing TDV and promoting healthy relationship behaviors among middle school students. In this study, we examine the prevention effects on secondary outcomes, including victimization and perpetration of physical violence, bullying, and cyberbullying. This study examined the effectiveness of Dating Matters compared to a standard-of-care TDV prevention program in 46 middle schools in four high-risk urban communities across the USA. The analytic sample (N = 3301; 53% female; 50% Black, non-Hispanic; and 31% Hispanic) consisted of 6th-8th grade students who had an opportunity for exposure to Dating Matters in all three grades or the standard-of-care in 8th grade only. Results demonstrated that both male and female students attending schools implementing Dating Matters reported 11% less bullying perpetration and 11% less physical violence perpetration than students in comparison schools. Female Dating Matters students reported 9% less cyberbullying victimization and 10% less cyberbullying perpetration relative to the standard-of-care. When compared to an existing evidence-based intervention for TDV, Dating Matters demonstrated protective effects on physical violence, bullying, and cyberbullying for most groups of students. The Dating Matters comprehensive prevention model holds promise for reducing multiple forms of violence among middle school-aged youth. ClinicalTrials.gov Identifier: NCT01672541. [ABSTRACT FROM AUTHOR]

Background: Medication adherence is challenging for older adults due to factors such as the number of medications, dosing schedule, and the duration of drug therapy. The objective of this study was to examine the effectiveness of an in-home electronic medication dispensing system (MDS) on improving medication adherence and health perception in older adults with chronic conditions.Methods: A pilot Randomized Controlled Trial (RCT) was conducted using a two-arm parallel assignment model. The intervention group used an MDS as their medication management method. The control group continued to use their current methods of medication management. Block randomization was used to assign participants into the intervention or control group. The inclusion criteria included 1) English speaking 2) age 50 and over 3) diagnosed with one or more chronic condition(s) 4) currently taking five or more oral medications 5) City of Calgary resident. Participants were recruited from a primary care clinic in Alberta, Canada. The study was open-label where knowledge about group assigned to participants after randomization was not withheld. Medication adherence was captured over a continuous, six-month period and analyzed using Intention-to-Treat (ITT) analysis.Results: A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups. The number of participants analyzed for ITT was 23 and 25 in the intervention and control group, respectively. Most of the demographic characteristics were comparable in the two groups except the mean age of the intervention group, which was higher compared to the control group (63.96 ± 7.86 versus 59.52 ± 5.93, p-value = 0.03). The average recorded adherence over 26 weeks was significantly higher in the intervention group than the control group (98.35% ± 2.15% versus 91.17% ± 9.76%, p < 0.01). The self-rated medication adherence in the intervention group also showed a significant increase from baseline to 6-month (Z=-2.65, p < 0.01). The control group showed a non-significant increase (Z=-1.79, p = 0.07).Conclusion: The MDS can be an effective, long-term solution to medication non-adherence in older adults experiencing chronic conditions and taking multiple medications. The technology induces better consistency and improvement in medication taking behaviour than simple, non-technological intervention.Trial Registration: Registered with ClinicalTrials.gov on April 09, 2020 with identifier NCT04339296 . [ABSTRACT FROM AUTHOR]

Background: Surgical site infection (SSI) is one of the most common complications after abdominal surgery. The present trial examined the efficacy of saline irrigation of open appendectomy wound with or without topical antibiotics in prevention of SSI.Methods: This was a double-blind randomized trial on patients with acute appendicitis who underwent open appendectomy. Patients were randomly allocated to one of three equal groups; group I had layer-by-layer wound irrigation with gentamicin-saline solution, group II had wound irrigation with saline solution, and group III received no irrigation (Control group). The main outcome measures were the incidence of incisional SSI, surgical site occurrence (SSO), other complications, operation time, postoperative pain, and patients' satisfaction.Results: 205 patients (113 female) of a mean age of 27.9 years were included. The average hospital stay and pain scores were similar in the three groups. Groups I and II had significantly lower rates of incisional SSI (4.3% Vs 2.9%; Vs 17.4%, p = 0.005) and SSO (24.6% Vs 13.4% Vs 43.5%; p = 0.0003) as compared to group III. Groups I and II had comparable rates of SSI and SSO. The three groups had similar rates of wound seroma, hematoma, and dehiscence. Groups I and II had significantly higher satisfaction with the procedure than group III.Conclusions: Layer-by-layer irrigation of open appendectomy wound decreased the rates of incisional SSI and SSO significantly compared to the no-irrigation group. Adding gentamicin to saline solution was useless to improve the outcome and did not decrease rates of SSI or other complications. [ABSTRACT FROM AUTHOR]

Background: A current recommendation for the treatment of patients with locoregionally advanced nasopharyngeal carcinoma (NPC) is conventional fractionated radiotherapy (RT) with concurrent cisplatin followed by adjuvant cisplatin and 5-fluorouracil (PF). This randomized NPC-0501 trial evaluated the therapeutic effect of changing to an induction-concurrent sequence or accelerated-fractionation sequence, and/or replacing 5-fluorouracil with capecitabine (X).Methods: Patients with American Joint Committee on Cancer/International Union Against Cancer stage III to stage IVB NPC initially were randomly allocated to 1 of 6 treatment arms (6-arm full-randomization cohort). The protocol was amended in 2009 to permit centers to opt out of randomization regarding fractionation (3-arm chemotherapy cohort).Results: A total of 803 patients were accrued (1 of whom was nonevaluable) from 2006 to 2012. Based on the overall comparisons, neither changing the chemotherapy sequence nor accelerated fractionation improved treatment outcome. However, secondary analyses demonstrated that when adjusted for RT parameters and other significant factors, the induction-concurrent sequence, especially the induction-PX regimen, achieved significant improvements in progression-free survival (PFS) and overall survival. Efficacy varied among different RT groups: although no impact was observed in the accelerated-fractionation group and the 3-arm chemotherapy cohort, a comparison of the induction-concurrent versus concurrent-adjuvant sequence in the conventional-fractionation group demonstrated a significant benefit in PFS (78% vs 62% at 5 years; P = .015) and a marginal benefit in overall survival (84% vs 72%; P = .042) after adjusting for multiple comparisons. Comparison of the induction-PX versus the adjuvant-PF regimen demonstrated better PFS (78% vs 62%; P = .027) without an increase in overall late toxicity.Conclusions: For patients irradiated using conventional fractionation, changing the chemotherapy sequence from a concurrent-adjuvant to an induction-concurrent sequence, particularly using induction cisplatin and capecitabine, potentially could improve efficacy without an adverse impact on late toxicity. However, further validation is needed for confirmation of these findings. [ABSTRACT FROM AUTHOR]

The study evaluated the implementation fidelity and effectiveness of KiVa, an evidence-based program that aims to prevent and address bullying in schools, with a particular emphasis on changing the role of bystanders. The study was a two-arm waitlist control cluster randomized controlled trial in which 22 primary schools (clusters) (N = 3214 students aged 7-11) were allocated using a 1:1 ratio to intervention (KiVa; 11 clusters, n = 1588 students) and a waitlist control (usual school provision; 11 clusters, n = 1892 children)). The trial statistician (but not schools or researchers) remained blind to allocation status. The outcomes were as follows: student-reported victimization (primary outcome) and bullying perpetration; teacher-reported child behavior and emotional well-being; and school absenteeism (administrative records). Implementation fidelity was measured using teacher-completed online records (for class lessons) and independent researcher observations (for school-wide elements). Outcome analyses involved 11 intervention schools (n = 1578 children) and 10 control schools (n = 1636 children). There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p = 0.11) or on the secondary outcomes. The impact on victimization was not moderated by child gender, age, or victimization status at baseline. Lesson adherence was good but exposure (lesson length) was lower than the recommended amount, and there was considerable variability in the implementation of whole school elements. The trial found insufficient evidence to conclude that KiVa had an effect on the primary outcome. A larger trial of KiVa in the UK is warranted, however, with attention to issues regarding implementation fidelity. Trial registration: Current Controlled Trials ISRCTN23999021 Date 10-6-13. [ABSTRACT FROM AUTHOR]

Study Question: Does an artificially induced FSH surge at the time of hCG trigger improve IVF/ICSI outcomes?Summary Answer: An additional FSH bolus administered at the time of hCG trigger has no effect on clinical pregnancy rate, embryo quality, fertilization rate, implantation rate and live birth rate in women undergoing the long GnRH agonist (GnRHa) protocol for IVF/ICSI.What Is Known Already: Normal ovulation is preceded by a surge in both LH and FSH. Few randomized clinical trials have specifically investigated the role of the FSH surge. Some studies indicated that FSH given at hCG ovulation trigger boosts fertilization rate and even prevents ovarian hyperstimulation syndrome (OHSS).Study Design, Size, Duration: This was a randomized, double-blinded, placebo-controlled trial conducted at a single IVF center, from June 2012 to November 2013. A sample size calculation indicated that 347 women per group would be adequate. A total of 732 women undergoing IVF/ICSI were randomized, using electronically randomized tables, to the intervention or placebo groups. Participants and clinical doctors were blinded to the treatment allocation.Participants/materials, Setting, Methods: Patients aged ≤42 years who were treated with IVF/ICSI owing to tubal factor, male factor, unexplained, endometriosis and multiple factors were enrolled in this trial. Subjects all received a standard long GnRHa protocol for IVF/ICSI and hCG 6000-10 000 IU to trigger oocyte maturation. A total of 364 and 368 patients were randomized to receive a urinary FSH (uFSH) bolus (6 ampules, 450 IU) and placebo, respectively, at the time of the hCG trigger. The primary outcome measure was clinical pregnancy rate. The secondary outcome measures were FSH level on the day of oocyte retrieval, number of oocytes retrieved, good-quality embryo rate, live birth rate and rate of OHSS.Main Results and the Role Of Chance: There were no significant differences in the baseline demographic characteristics between the two study groups. There were also no significant differences between groups in cycle characteristics, such as the mean number of stimulation days, total gonadotrophin dose and peak estradiol. The clinical pregnancy rate was 51.6% in the placebo group and 52.7% in the FSH co-trigger group, with an absolute rate difference of 1.1% (95% CI -6.1% to 8.3%). The number of oocytes retrieved was 10.47 ± 4.52 and 10.74 ± 5.01 (P = 0.44), the rate of good-quality embryos was 37% and 33.9% (P = 0.093) and the implantation rate was 35% and 36% (P = 0.7) in the placebo group and the FSH co-trigger group, respectively.Limitations, Reasons For Caution: This was a single-center study, which may limit its effectiveness. The use of uFSH is a limitation, as this is not the same as the natural FSH. We did not collect follicular fluid for further study of molecular changes after the use of uFSH as a co-trigger.Wider Implications Of the Findings: Based on previous data and our results, an additional FSH bolus administered at the time of hCG trigger has no benefit on clinical pregnancy rates in women undergoing the long GnRHa protocol in IVF/ICSI: a single hCG trigger is sufficient.Study Funding/competing Interest(s): This study was supported by the National Key Research and Development Program of China (2016YFC1000205); Sun Yat-Sen University Clinical Research 5010 Program (2016004); the Science and Technology Project of Guangdong Province (2016A020216011 and 2017A020213028); and Science Technology Research Project of Guangdong Province (S2011010004662). There are no conflicts of interest to declare.Trial Registration Number: The trial was registered in the Chinese Clinical Trial Registry (ChiCTR-TRC-12002246).Trial Registration Date: 20 May 2012.Date Of First Patient’s Enrolment: 10 June 2012. [ABSTRACT FROM AUTHOR]

Background: Short messages service (SMS) provides a practical medium for delivering content to address patients to adherence to self-management. The aim of study was to design some patient-centered health education messages, evaluate the feasibility of messages, and explore the effect of this model.Methods: The messages were designed by a panel of experts, and SMS Quality Evaluation Questionnaire was used to evaluate their quality. A two-arm randomized controlled trial was conducted to evaluate the effectiveness of this management model. Participants were randomly divided into an intervention group (IG) who received evaluated messages and a control group (CG) who received regular education. The primary outcomes were changes in plasma glucose and control rates, and the secondary outcomes were improvements in diet control, physical activities, weight control, etc. RESULTS: A total of 42 messages covering five main domains: health awareness, diet control, physical activities, living habits and weight control were designed, and the average scores of the messages were 8.0 (SD 0.7), 8.5 (SD 0.6), 7.9 (SD 1.0), 8.0 (SD 0.7), and 8.4 (SD 0.9), respectively. In the SMS intervention, 171 patients with an average age of 55.1 years were involved, including 86 in the CG and 85 in the IG. At 12 months, compared with the control group (CG), the decrease of fasting plasma glucose (FPG) (1.5 vs. 0.4, P = 0.011) and control rate (49.4% vs. 33.3%, P = 0.034), the postprandial glucose (PPG) (5.8 vs. 4.2, P = 0.009) and control rate (57.8% vs. 33.7%, P = 0.002) were better in the intervention group (IG). In terms of self-management, improvements in weight control (49.3% vs. 28.2%, P = 0.031), vegetables consumption (87.3% vs. 29.0%, P < 0.001), fruits consumption (27.5% vs. 7.4%, P = 0.022), and physical activities (84.7% vs. 70.0%, P = 0.036) were better in the IG than in the CG.Conclusions: The overall quality of the messages was high. It was effective and feasible to carry out an SMS intervention to improve the behavioral habits of patients with chronic diseases in remote and undeveloped areas.Trial Registration: Clinicaltrials.gov, ChiCTR1900023445. Registered May 28, 2019--Retrospectively registered. [ABSTRACT FROM AUTHOR]

Hangovers are associated with negative economic consequences due to decreased job performance or frequent visits to physicians. Thus, a new strategy for the alleviation of hangover-related symptoms is needed to avoid this detriment to society. The purpose of this nationwide randomized, double-blind, placebo-controlled physicians' trial was to evaluate the efficacy of loxoprofen sodium for the alleviation of fatigue, headache, and nausea after hangover. A total of 229 participants were randomized to receive loxoprofen sodium (60 mg once orally) or placebo. The study was closed when the first 150 participants (n = 74 in the loxoprofen vs. n = 76 in the placebo groups) experienced hangovers. The primary endpoint was set as the difference in severity of general fatigue before and 3 h after taking the test drugs and was evaluated using a visual analogue scale. Secondary endpoints included difference in severity of headache, nausea, and incidence of adverse events. The study participants were 34 (interquartile range; 30-39) years old, 92.0% were men, and both groups were comparable for baseline characteristics. The alleviation of general fatigue did not differ statistically between the loxoprofen and placebo groups (24 [14-49] vs. 19 [9-35], p = 0.07). However, the alleviation of headache was statistically greater in the loxoprofen group (25 [10-50] vs. 10 [2-30], adjusted difference 14, 95% confidence interval 8-21, p < 0.001), whereas, there was no difference in nausea (7 [0-27] vs. 10 [0-24], p = 0.68). The incidence of adverse symptoms such as epigastric discomfort was also comparable between groups (2.7% vs. 3.9%, p = 0.25). Loxoprofen sodium was effective for relieving headaches after hangovers but did not alleviate general fatigue or nausea. [ABSTRACT FROM AUTHOR]

Background: Effects of very low carbohydrate (VLC) diets on appetite response in individuals with type 2 diabetes remain unclear.Objective: A secondary analysis was conducted to determine appetite responses to an energy-restricted [30% of energy (%E) deficit] very low carbohydrate (VLC) diet compared with a higher carbohydrate (HC) diet in adults who were overweight or obese with type 2 diabetes.Methods: Forty-four men and 40 women (mean ± SD, age: 58.7 ± 6.6 y; weight: 100.4 ± 15.5 kg; BMI: 34.5 ± 4.1 kg/m2; glycated hemoglobin: 7.3 ± 1.0%; duration of diabetes: 6.7 ± 5.6 y) were randomly assigned to diets categorized as VLC [14%E carbohydrate (<50 g/d), 28%E protein, 58%E fat (<10%E saturated fat)], or energy-matched HC [53%E carbohydrate, 17%E protein, 30%E fat (<10%E saturated fat)] combined with progressive multicomponent exercise (60 min; 3 d/wk). Body weight, average weekly "daily fasting" and "daily overall" appetite perceptions (hunger, fullness, prospective consumption, and desire to eat-visual analog scales) were assessed at baseline and after 4 and 16 wk. Changes between diets over time were assessed using repeated measures ANOVA.Results: Significant decreases in body weight did not differ between groups (VLC: -11.0 ± 5.4 kg/16 wk compared with HC: -10.1 ± 4.3 kg/16 wk, P = 0.40). Compared with HC, VLC had greater decreases in "daily overall" ratings of fullness (P time × diet < 0.01), such that scores were higher in HC at Week 4 (VLC:48 ± 3 vs HC:56 ± 3 mm, P = 0.001) and 16 (VLC:51 ± 2 vs HC:57 ± 3 mm, P = 0.019). Compared with HC, VLC had greater increases in prospective consumption ratings (P time × diet = 0.03), such that scores were lower in HC at Week 4 (VLC:33 ± 2 vs HC:28 ± 2 mm, P = 0.008), but not at Week 16 (VLC:33 ± 2 vs HC 31 ± 2 mm, P = 0.289).Conclusions: In the context of energy restriction, both HC and VLC energy-matched diets promoted comparable effects on fasting perceptions of appetite, but the HC diet resulted in greater "daily overall" fullness and reduced prospective consumption. Further research is required to evaluate the effects of ad libitum diets differing in amounts of carbohydrate on appetite response in populations with type 2 diabetes. This trial was registered at www.anzctr.org.au as ACTRN12612000369820. [ABSTRACT FROM AUTHOR]

Background: Internet-based intervention could help drug users recover from drug dependence. This study evaluated the effectiveness of a newly developed web-based relapse prevention program (e-SMARPP) for people with a drug problem, including the use of methamphetamine, in Japan.Methods: The study was a pilot randomized controlled trial comprised of 48 psychiatric outpatients diagnosed with drug use disorder. The participants were randomly assigned to an eight-week, six-session web-based relapse prevention program (an intervention group) or only web-based self-monitoring (a control group). The primary outcome was the duration of abstinence from a primary drug during the intervention and relapse risk. Secondary outcomes included motivation to change, self-efficacy, and money spent on drugs. The outcomes, except for the duration of abstinence during the intervention, were assessed at baseline, 2-, 5-, and 8-months. Program completion rate was also assessed.Results: No significant difference was observed between the intervention and the control groups for the primary and the secondary outcomes. The effect size of the duration of abstinence during the intervention was d = 0.42, which was comparable to previous studies. In the intervention group, about 26% did not complete the entire intervention.Conclusions: e-SMARPP failed to demonstrate efficacy, however, is potentially helpful for enhancing abstinence. The low attrition rate may suggest the acceptance and feasibility of the program. Further improvement of the program and evaluation in a full-scale trial are needed. [ABSTRACT FROM AUTHOR]

Background: The application of telemedicine in home pulmonary rehabilitation interventions for the management of patients with chronic obstructive pulmonary disease (COPD) has achieved promising results.Objective: This study aimed to develop a WeChat official account (Pulmonary Internet Explorer Rehabilitation [PeR]) based on social media. It further evaluated the effect of PeR on the quality of life, symptoms, and exercise self-efficacy of patients with COPD.Methods: The functional modules of PeR were developed by a multidisciplinary team according to the electronic health-enhanced chronic care model (eCCM) components. A total of 106 patients were randomly selected (53 in the PeR group and 53 in the outpatient face-to-face group [FtF]). Pulmonary rehabilitation intervention was conducted for 3 months, and the outcome was observed for 3 months. The primary outcome was patient quality of life measured with the COPD assessment test (CAT). The secondary outcomes were evaluated using the modified Medical Research Council scale (mMRC), exercise self-regulatory efficacy scale (Ex-SRES), and St George's Respiratory Questionnaire (SGRQ).Results: The intention-to-treat analysis was used in the study. A total of 94 participants completed the 6-month pulmonary rehabilitation program. No statistically significant differences were observed in CAT (F1,3=7.78, P=.001), Ex-SRES (F1,3=21.91, P<.001), and mMRC scores (F1,3=29.64, P<.001) between the two groups with the variation in time tendency. The Ex-SRES score had a significant effect on the CAT score (P=.03). The partial regression coefficient of Ex-SRES to CAT was 0.81, and Exp (B) was 2.24.Conclusions: The telemedicine technology was effective using the eCCM combined with a behavioral intervention strategy centering on self-efficacy. Pulmonary rehabilitation at home through PeR and FtF could improve the sense of self-efficacy and quality of life and alleviate symptoms in patients with COPD.Trial Registration: Chinese Clinical Trial Registry ChiCTR1900022770; https://tinyurl.com/tmmvpq3. [ABSTRACT FROM AUTHOR]

Objective: Psychoeducation forms part of the current practice for ADHD; however, its efficacy is yet to be established. Method: Sixty-nine children/adolescents with ADHD were randomly assigned for their families to receive either a well-structured psychoeducation program (n = 35), or belong to a control group (treatment-as-usual, n = 34). Results: One-way analyses of variance showed a statistically significant Treatment × Time interaction, for ADHD total symptoms, inattention/cognition, and hyperactivity/impulsivity subdomains according to the parents, the first two with medium-large effect sizes. The effects of the intervention on the ADHD total and the inattention/cognition domain persisted after 6 months follow-up. No significant differences in teacher ratings were found; however, an improvement in clinical functioning as measured by clinicians was observed. Conclusion: This psychoeducation program has shown effectiveness in reducing ADHD symptoms when compared with treatment as usual. Psychoeducation needs to be considered as a valid and additional approach in ADHD. [ABSTRACT FROM AUTHOR]

Background: Fatigue is a common and disabling side effect of targeted therapies such as tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia (CML). The goal of the current study was to conduct a pilot randomized trial of the first cognitive behavioral intervention developed for fatigue due to targeted therapy.Methods: Patients with CML treated with a TKI who were reporting moderate to severe fatigue were recruited and randomized 2:1 to cognitive behavioral therapy for targeted therapy-related fatigue (CBT-TTF) delivered via FaceTime for the iPad or to a waitlist control (WLC) group. The outcomes were acceptability, feasibility, and preliminary efficacy for fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General; secondary outcome). Participants were assessed before randomization and after treatment (ie, approximately 18 weeks later).Results: A total of 44 patients (mean age, 55 years; 48% female) were assigned to CBT-TTF (n = 29) or WLC (n = 15). The study participation rate was 59%. Among the patients assigned to CBT-TTF, 79% completed the intervention. Intent-to-treat analyses indicated that patients assigned to CBT-TTF demonstrated greater improvements in fatigue (d = 1.06; P < .001) and overall quality of life (d = 1.15; P = .005) than those assigned to WLC. More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016).Conclusions: CBT-TTF displays preliminary efficacy in improving fatigue and quality of life among fatigued patients with CML treated with TKIs. The findings suggest that a larger randomized study is warranted. [ABSTRACT FROM AUTHOR]

Background and Aims: Despite advances in pharmacological and endoscopic management of non-variceal upper gastrointestinal bleeding (NVUGIB), mortality is still relevant. TC-325 (Hemospray-Cook Medical) is a mineral powder with adsorptive properties, designed for endoscopic hemostasis. There are still no comparative trials studying this new hemostatic modality. The objective of this research was to compare the use of TC-325 (associated with epinephrine injection) with the combined technique of endoscopic clipping and epinephrine injection for the treatment of patients with NVUGIB.Methods: We conducted a pilot randomized controlled trial with patients that presented NVUGIB with an actively bleeding lesion at the endoscopic evaluation. Patients were randomized either to the Hemospray or Hemoclip group. The randomization list was generated by a computer program and remained unknown throughout the entire trial. All patients underwent second-look endoscopy.Results: Thirty-nine patients were enrolled. Peptic ulcer was the most frequent etiology. Primary hemostasis was achieved in all Hemospray cases and in 90% of Hemoclip group (p = 0.487). Five patients in Hemospray group underwent an additional hemostatic procedure during second-look endoscopy, while no patient in the Hemoclip group needed it (p = 0.04). Rebleeding, emergency surgery and mortality rates were similar in both groups. No toxicity, allergy events, or gastrointestinal obstruction signs were observed in Hemospray group.Conclusions: TC-325 presents similar hemostatic results when compared with conventional dual therapy for patients with NVUGIB. Hemospray's excellent primary hemostasis rate certifies it as a valuable tool in arduous situations of severe bleeding or difficult location site. [ABSTRACT FROM AUTHOR]

Objectives: Trauma resuscitations are complex critical care events that present patient safety-related risk. Simulation-based leadership training is thought to improve trauma care; however, there is no robust evidence supporting the impact of leadership training on clinical performance. The objective of this study was to assess the clinical impact of simulation-based leadership training on team leadership and patient care during actual trauma resuscitations.Design: Randomized controlled trial.Setting: Harborview Medical Center (level 1 trauma center).Subjects: Seventy-nine second- and third-year residents were randomized and 360 resuscitations were analyzed.Interventions: Subjects were randomized to a 4-hour simulation-based leadership training (intervention) or standard orientation (control) condition.Measurements and Main Results: Participant-led actual trauma resuscitations were video recorded and coded for leadership behaviors and patient care. We used random coefficient modeling to account for the nesting effect of multiple observations within residents and to test for post-training group differences in leadership behaviors while controlling for pre-training behaviors, Injury Severity Score, postgraduate training year, and days since training occurred. Sixty participants completed the study. There was a significant difference in post-training leadership behaviors between the intervention and control conditions (b1 = 4.06, t (55) = 6.11, p < 0.001; intervention M = 11.29, SE = 0.66, 95% CI, 9.99-12.59 vs control M = 7.23, SE = 0.46, 95% CI, 6.33-8.13, d = 0.92). Although patient care was similar between conditions (b = 2.00, t (55) = 0.99, p = 0.325; predicted means intervention M = 62.38, SE = 2.01, 95% CI, 58.43-66.33 vs control M = 60.38, SE = 1.37, 95% CI, 57.69-63.07, d = 0.15), a test of the mediation effect between training and patient care suggests leadership behaviors mediate an effect of training on patient care with a significant indirect effect (b = 3.44, 95% CI, 1.43-5.80). Across all trauma resuscitations leadership was significantly related to patient care (b1 = 0.61, SE = 0.15, t (273) = 3.64, p < 0.001).Conclusions: Leadership training resulted in the transfer of complex skills to the clinical environment and may have an indirect effect on patient care through better team leadership. [ABSTRACT FROM AUTHOR]

Background: Photoactivated disinfection (PAD) could support the periodontal treatment outcome. The effect of the light emitting diode (LED) as an innovative light source in PAD is under discussion. The aim of this study was to evaluate the clinical and microbiological effect of adjunctive PAD in the treatment of periodontitis with a red LED as light source.Methods: Twenty patients with periodontitis completed this split-mouth study. The left and right side of the jaws were randomly assigned to either test or control group. After conservative periodontal treatment in both groups, the test group received two sessions of adjunctive PAD (red LED, 635 nm, photosensitive dye, 0.01% tolonium chloride), whereas the control group received no adjunctive PAD. The parameters of clinical periodontal examination-including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP) and microbiological assays (PCR) were evaluated before and after treatment.Results: After 3 months, both treatment groups showed significant improvements regarding BOP, PD, and CAL compared to baseline, with no significant difference between control and treatment group. The recolonization of Porphyromonas gingivalis and Treponema denticola was reduced after adjuvant treatment, but not significantly.Conclusions: The positive effect of adjunctive PAD regarding clinical parameters was reported in recent trials. In this study and with the current settings, both treatment groups showed similar clinical results after initial periodontal treatment, without beneficial effect of adjunctive PAD. [ABSTRACT FROM AUTHOR]

Context: The optimal dose of fentanyl sublingual spray (FSS) for exertional dyspnea has not been determined.Objectives: We examined the effect of two doses of prophylactic FSS on exertional dyspnea.Methods: In this parallel, dose-finding, double-blind randomized clinical trial, opioid-tolerant cancer patients completed a shuttle walk test at baseline. Patients completed a second shuttle walk test 10 minutes after a single dose of FSS equivalent to either 35%-45% (high dose) or 15%-25% (low dose) of the total daily opioid dose. The primary outcome was change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. Secondary outcomes included adverse events as well as changes in walk distance, vital signs, and neurocognitive function.Results: Thirty of the 50 enrolled patients completed the study. High-dose FSS (n = 13) resulted in significantly lower dyspnea (mean change -1.42; 95% CI -2.37, -0.48; P = 0.007) and greater walk distance (mean change 44 m; P = 0.001) compared to baseline. Low-dose FSS (n = 17) resulted in a nonsignificant reduction in dyspnea (mean change -0.47; 95% CI -1.26, 0.32; P = 0.24) and significant increase in walk distance (mean change 24 m; P = 0.01) compared to baseline. Global evaluation showed high-dose group was more likely to report at least somewhat better improvement (64% vs. 24%; P = 0.06). No significant adverse events or detriment to vital signs or neurocognitive function was detected.Conclusion: Prophylactic FSS was well tolerated and demonstrated a dose-response relationship in improving both dyspnea and walk distance. High-dose FSS should be tested in confirmatory trials. [ABSTRACT FROM AUTHOR]

Objectives: To investigate whether XueBiJing injection improves clinical outcomes in critically ill patients with severe community-acquired pneumonia.Design: Prospective, randomized, controlled study.Setting: Thirty-three hospitals in China.Patients: A total of 710 adults 18-75 years old with severe community-acquired pneumonia.Interventions: Participants in the XueBiJing group received XueBiJing, 100 mL, q12 hours, and the control group received a visually indistinguishable placebo.Measurements and Main Results: The primary outcome was 8-day improvement in the pneumonia severity index risk rating. Secondary outcomes were 28-day mortality rate, duration of mechanical ventilation and total duration of ICU stay. Improvement in the pneumonia severity index risk rating, from a previously defined endpoint, occurred in 203 (60.78%) participants receiving XueBiJing and in 158 (46.33%) participants receiving placebo (between-group difference [95% CI], 14.4% [6.9-21.8%]; p < 0.001). Fifty-three (15.87%) XueBiJing recipients and 84 (24.63%) placebo recipients (8.8% [2.4-15.2%]; p = 0.006) died within 28 days. XueBiJing administration also decreased the mechanical ventilation time and the total ICU stay duration. The median mechanical ventilation time was 11.0 versus 16.5 days for the XueBiJing and placebo groups, respectively (p = 0.012). The total duration of ICU stay was 12 days for XueBiJing recipients versus 16 days for placebo recipients (p = 0.004). A total of 256 patients experienced adverse events (119 [35.63%] vs 137 [40.18%] in the XueBiJing and placebo groups, respectively [p = 0.235]).Conclusions: In critically ill patients with severe community-acquired pneumonia, XueBiJing injection led to a statistically significant improvement in the primary endpoint of the pneumonia severity index as well a significant improvement in the secondary clinical outcomes of mortality, duration of mechanical ventilation and duration of ICU stay. [ABSTRACT FROM AUTHOR]

Background: Peripherally inserted central catheters (PICCs) are used to administer parenteral nutrition (PN) in very low birth weight infants (VLBW; <1500 g). Clinicians try to optimize early nutrition but also minimize the risks associated with intravascular devices. The objective of this study was to examine the early nutrition impact of discontinuing PN at different enteral feed volumes in VLBW infants.Methods: In this unmasked, multicenter, randomized controlled trial, patients were randomly assigned to PICC removal and PN discontinuation at an enteral feed volume of 100 mL/kg/day (intervention) or 140 mL/kg/day (control). Clinically stable VLBW infants with a PICC in situ who were receiving PN were eligible for inclusion. Infants with major congenital anomalies were excluded. A total of 139 patients were enrolled; 69 and 70 patients were randomized to the intervention and control groups, respectively. The primary outcome measure was the mean difference in time (days) to regain birth weight.Results: The groups were well matched at study entry. Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01). The mean difference in time to regain birth weight for infants <1000 g was 2.8 days (95% CI: 0.8-4.8 days, P = 0.008).Conclusions: In VLBW infants, early PICC removal at an enteral feed volume of 100 mL/kg/day compared with later removal at 140 mL/kg/day resulted in a significant delay in time to regain birth weight, and this delay was more pronounced in infants <1000 g. [ABSTRACT FROM AUTHOR]

Background: Defense mechanisms play an important role in the development and maintenance of both health and psychopathology. Research is still in the early stages of investigating the specific relationships among diagnostic groups and defense mechanisms along with their response to different treatment types.Methods: For the present study a total of 47 outpatients diagnosed with depression or anxiety disorders were randomized to receive 25±3 sessions of cognitive-behavioral therapy with integrated elements of either emotion-focused therapy (CBT + EFT) or treatment components based on self-regulation theory (CBT + SR). An observer-rated method, the Defense Mechanism Rating Scale (DMRS) was used to code transcripts of the 1st, 8th, 16th and 24th session to assess change in defensive functioning.Results: Over the course of therapy, overall defensive functioning (ODF) as well as adaptive defenses increased significantly, whereas maladaptive and neurotic defenses did not change. At the beginning of treatment, the proportion of adaptive defenses and ODF was significantly higher in patients diagnosed with anxiety disorders than in patients with depressive disorders. However, depressed patients exhibited greater improvement in their defensive functioning over the course of therapy.Conclusions: Results support the view of defense mechanisms as a useful transdiagnostic and transtheoretical concept and supports the notion that change of defense mechanisms may be a relevant mechanism of change in psychotherapy. [ABSTRACT FROM AUTHOR]

Purpose: Head and neck cancer and its treatment deteriorate quality of life, but symptoms improve with person-centred care. We examined the cost-effectiveness of a person-centred care intervention versus standard medical care.Methods: In this randomized clinical trial of a person-centred intervention, patients were planned for outpatient oncology treatment in a Swedish university hospital between 2012 and 2014 and were followed during 1 year. Annual healthcare costs were identified from medical records and administrative register data. Productivity costs were calculated from reported sick leave. Health-related quality of life was collected using the EuroQol Group's five-dimension health state questionnaire.Results: Characteristics were similar between 53 patients in the intervention group and 39 control patients. The average total cost was Euro (EUR) 55,544 (95% confidence interval: EUR 48,474-62,614) in the intervention group and EUR 57,443 (EUR 48,607-66,279) among controls, with similar health-related quality of life.Conclusions: This person-centred intervention did not result in increased costs and dominated the standard medical care.Trial Registration: ClinicalTrials.gov (registration number: NCT02982746). [ABSTRACT FROM AUTHOR]

Background: Negative symptoms are frequent in patients with schizophrenia and are associated with marked impairments in social functioning. The efficacy of drug-based treatments and psychological interventions on primary negative symptoms remains limited. The Positive Emotions Programme for Schizophrenia (PEPS) is designed to improve pleasure and motivation in schizophrenia patients by targeting emotion regulation and cognitive skills relevant to apathy and anhedonia. The main hypothesis of this study is that patients who attend 8 one-hour sessions of PEPS and treatment as usual (TAU) will have lower total apathy-avolition and anhedonia-asociality composite scores on the Scale for the Assessment of Negative Symptoms (SANS) than patients who attend only TAU.Methods: Eighty participants diagnosed with schizophrenia or schizoaffective disorder were randomized to receive either TAU or PEPS + TAU. The participants were assessed by independent evaluators before randomization (T0), in a post-test after 8 weeks of treatment (T1) and at a 6-month follow-up (T2).Results: The post-test results and 6-month follow-up assessments according to an intention-to-treat analysis showed that the apathy and anhedonia composite scores on the SANS indicated statistically greater clinical improvements in PEPS participants than in non-PEPS participants. In the post-test, anhedonia but not apathy was significantly improved, thus favouring the PEPS condition. These results were sustained at the 6-month follow-up.Conclusions: PEPS is an effective intervention to reduce anhedonia in schizophrenia. PEPS is a short, easy-to-use, group-based, freely available intervention that is easy to implement in a variety of environments (ClinicalTrials.gov ID: NCT02593058). [ABSTRACT FROM AUTHOR]

Purpose: Vena cava syndrome (VCS) from stenosis of the superior vena cava or inferior vena cava caused by compression from a malignant tumor is one of the typical clinical conditions in patients with advanced stage malignant disease. VCS is difficult to manage and painful, reducing patients' quality of life. Although several reports have investigated stent placement for VCS, this treatment has never been established as the standard because of the lack of evidence of the safety and efficacy. We conducted a phase II trial and a phase III randomized controlled trial to clarify the role of stent placement in managing patients with VCS.Methods: In the phase II trial, 28 eligible patients were treated with stent placement. The efficacy of stent placement for VCS was evaluated based on the reduction of patients' symptom scores during 14 days following treatment. Technical success, technical feasibility, overall survival, recurrence of symptoms, and adverse events were evaluated. In the phase III trial, 32 patients were enrolled and randomly assigned to the test (n = 16) and control groups (n = 16). The area under the symptom score curve was compared between the groups. The EQ-5D, SF-8, and adverse events were evaluated until discontinuation of the protocol treatment or 28 days after enrollment.Results: In the phase II trial, the median patients' symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups.Conclusions: Stent placement significantly improved the symptoms of VCS; thus, it might be accepted as the standard treatment to manage the symptoms of VCS.Trial Registration: JIVROSG-0402, JIVROSG-0807. [ABSTRACT FROM AUTHOR]

Background Context: Lumbar spinal stenosis (LSS) can impair blood flow to the spinal nerves giving rise to neurogenic claudication and limited walking ability. Reducing lumbar lordosis can increases the volume of the spinal canal and reduce neuroischemia. We developed a prototype LSS belt aimed at reducing lumbar lordosis while walking.Purpose: The aim of this study was to assess the short-term effectiveness of a prototype LSS belt compared to a lumbar support in improving walking ability in patients with degenerative LSS.Study Design: This was a two-arm, double-blinded (participant and assessor) randomized controlled trial.Patient Sample: We recruited 104 participants aged 50 years or older with neurogenic claudication, imaging confirmed degenerative LSS, and limited walking ability.Outcome Measures: The primary measure was walking distance measured by the self-paced walking test (SPWT) and the primary outcome was the difference in proportions among participants in both groups who achieved at least a 30% improvement in walking distance from baseline using relative risk with 95% confidence intervals.Methods: Within 1 week of a baseline SPWT, participants randomized to the prototype LSS belt group (n=52) and those randomized to the lumbar support group (n=52) performed a SPWT that was conducted by a blinded assessor. The Arthritis Society funded this study ($365,000 CAN) with salary support for principal investigator funded by the Canadian Chiropractic Research Foundation ($500,000 CAN for 5 years).Results: Both groups showed significant improvement in walking distance, but there was no significant difference between groups. The mean group difference in walking distance was -74 m (95% CI: -282.8 to 134.8, p=.49). In total, 62% of participants wearing the prototype LSS belt and 82% of participants wearing the lumbar support achieved at least 30% improvement in walking distance (relative risk, 0.7; 95% CI: 0.5-1.3, p=.43).Conclusions: A prototype LSS belt demonstrated significant improvement in walking ability in degenerative LSS but was no better than a lumbar support. [ABSTRACT FROM AUTHOR]

Background: It remains unclear whether deep neuromuscular blockade results in better postoperative recovery than does moderate neuromuscular blockade. Therefore, in this study, we aimed to compare the effects of deep neuromuscular blockade and moderate neuromuscular blockade on the quality of postoperative recovery in patients undergoing robotic gastrectomy.Methods: In this prospective, double-blind, single-center randomized controlled superiority trial with two parallel groups, 56 adult patients (19-80 years) scheduled for elective robotic gastrectomy were randomly assigned to a moderate neuromuscular blockade group or a deep neuromuscular blockade group in a 1:1 ratio. In the deep and moderate neuromuscular blockade groups, the infusion rate for rocuronium was adjusted to maintain a post-tetanic count of 1-2 or a train-of-four count of 1-2, respectively. The primary outcome was the Quality of Recovery-40 (QoR-40) score on postoperative day 1. Secondary outcomes included the QoR-40 score on postoperative day 2, intraoperative hemodynamic data, intraoperative respiratory data, visual analog scale score for pain, postoperative incidences of nausea and vomiting, postoperative rescue analgesic use, and postoperative rescue antiemetic use.Results: The postoperative QoR-40 score was similar between the two groups on postoperative days 1 and 2. Moreover, the two groups showed no differences in intraoperative hemodynamic and respiratory data or postoperative pain, nausea and vomiting, and rescue medication use.Conclusion: Our findings suggest that the quality of recovery after robotic gastrectomy is similar for deep and moderate neuromuscular blockade. Therefore, deep neuromuscular blockade during robotic gastrectomy may be unnecessary, at least in patients with normal body mass index. [ABSTRACT FROM AUTHOR]

Background: Service providers including doctors, nurses, and other healthcare professionals play an essential role in methadone maintenance treatment (MMT). This study evaluated the impact of an intervention targeting MMT providers on their clients' treatment retention.Methods: This study was conducted in 68 MMT clinics in five provinces of China with 36 clients randomly selected from each clinic. The clinics were randomized to intervention or control condition. The MMT CARE intervention started with group sessions to enhance providers' communication skills. The trained providers were encouraged to conduct individual sessions with clients to promote treatment engagement. The outcomes, which include client retention (main outcome) and their reception of provider-delivered individual sessions (process outcome), were measured over a 24-month period.Results: Significantly fewer intervention clients dropped out from MMT than control clients during the study period (31% vs. 41%; p < 0.0001). Dropout hazard was significantly lower in the intervention condition compared to the control condition (HR = 0.71, 95% CI: 0.57, 0.89). More intervention clients had individual sessions than control clients (93% vs. 70%; p < 0.0001). Having individual sessions was associated with a significantly lower dropout hazard (HR = 0.30, 95% CI: 0.23, 0.40). The intervention clients had a significantly lower dropout hazard than the control clients if they started the individual sessions during the first six months (HR = 0.68, 95% CI: 0.51, 0.90).Conclusions: The MMT CARE intervention focusing on provider capacity building has demonstrated efficacy in reducing clients' treatment dropout. This study sheds light on MMT service improvement in China and other global community-based harm reduction programs. [ABSTRACT FROM AUTHOR]

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119. [ABSTRACT FROM AUTHOR]

Background: Fermented milk products containing Bifidobacterium breve strain Yakult (BFM) may improve clinical status in ulcerative colitis (UC) patients.Aims: To assess efficacy of BFM in maintaining remission in Japanese patients with quiescent UC.Methods: This double-blind study (B-FLORA) enrolled 195 patients with quiescent UC, randomized to receive one pack of BFM fermented milk per day [Bifidobacterium breve strain Yakult (10 billion bacteria) and Lactobacillus acidophilus (1 billion bacteria)] (n = 98) or matching placebo (n = 97) for 48 weeks. The primary efficacy endpoint was relapse-free survival (relapse: rectal bleeding score ≥ 2 on Sutherland disease activity index scale for 3 consecutive days and/or initiation of remission induction therapy for worsening of UC).Results: An interim analysis was conducted after inclusion and follow-up of one-third of patients for the first phase of the study (n = 195). Relapse-free survival was not significantly different between the BFM and placebo groups (P = 0.643; hazard ratio 1.16; 95% CI 0.63-2.14, log-rank test), nor was the incidence of relapse. Therefore, the study was discontinued for lack of efficacy. An exploratory analysis of fecal samples from a subgroup of patients revealed no effects of either study beverage on intestinal microbiota, but there was a significant decrease in Bifidobacterium species before relapse, regardless of treatment group. Three mild adverse events occurred for which a causal relationship with the study beverage could not be ruled out (placebo: abdominal bloating and stress in one patient; BFM: body odor in one patient).Conclusions: BFM had no effect on time to relapse in UC patients compared with placebo.Study Registration: UMIN000007593. [ABSTRACT FROM AUTHOR]

Background: Compensatory pelvis, hip- and knee movements are reported after stroke to overcome insufficient foot-clearance. Ankle-foot orthoses (AFOs) are often used to improve foot-clearance, but the optimal timing of AFO-provision post-stroke is unknown. Early AFO-provision to prevent foot-drop might decrease the development of compensatory movements, but it is unknown whether timing of AFO-provision affects post-stroke kinematics.Research Questions: 1) To compare the effect of AFO-provision at two different points in time (early versus delayed) on frontal pelvis and hip, and sagittal hip and knee kinematics in patients with sub-acute stroke. Effects were assessed after 26 weeks; 2) To study whether possible changes in kinematics or walking speed during the 26-weeks follow-up period differed between both groups.Method: An explorative randomized controlled trial was performed, including unilateral hemiparetic patients maximal six weeks post-stroke with indication for AFO-use. Subjects were randomly assigned to AFO-provision early (at inclusion) or delayed (eight weeks later). 3D gait-analysis with and without AFO was performed in randomized order. Measurements were performed in study-week 1, 9, 17 and 26.Results: Twenty-six subjects (15 early, 11 delayed) were analyzed. After 26 weeks, no differences in kinematics were found between both groups for any of the joint angles, both for the without and with AFO-condition. Changes in kinematics during the 26-weeks follow-up period did not differ between both groups for any of the joint angles during walking without AFO. Significant differences in changes in walking speed during the 26-weeks follow-up were found (p = 0.034), corresponding to the first eight weeks after AFO-provision.Significance: Results indicate that early or delayed AFO-use post-stroke does not influence pelvis, hip and knee movements after 26 weeks, despite that AFO-use properly corrected drop-foot. AFOs should be provided to improve drop-foot post-stroke, but not with the intention to influence development of compensatory patterns around pelvis and hip. [ABSTRACT FROM AUTHOR]

Objectives: We tested whether complementary use of the somatostatin analogue pasireotide would augment efficacy of aspiration sclerotherapy of hepatic cysts.Methods: We conducted a double-blind, placebo-controlled trial in patients who underwent aspiration sclerotherapy of a large (>5 cm) symptomatic hepatic cyst. Patients were randomized to either intramuscular injections of pasireotide 60 mg long-acting release (n = 17) or placebo (sodium chloride 0.9 %, n = 17). Injections were administered 2 weeks before and 2 weeks after aspiration sclerotherapy. The primary endpoint was proportional cyst diameter reduction (%) from baseline to 6 weeks. Secondary outcomes included long-term cyst reduction at 26 weeks, patient-reported outcomes including the polycystic liver disease-questionnaire (PLD-Q) and safety.Results: Thirty-four patients (32 females; 53.6 ± 7.8 years) were randomized between pasireotide or placebo. Pasireotide did not improve efficacy of aspiration sclerotherapy at 6 weeks compared to controls (23.6 % [IQR 12.6-30.0] vs. 21.8 % [9.6-31.8]; p = 0.96). Long-term cyst diameter reduction was similar in both groups (49.1 % [27.0-73.6] and 45.6 % [29.6-59.6]; p = 0.90). Mean PLD-Q scores improved significantly in both groups (p < 0.01) without differences between arms (p = 0.92).Conclusions: In patients with large symptomatic hepatic cysts, complementary pasireotide to aspiration sclerotherapy did not improve cyst reduction or clinical response.Key Points: • Complementary pasireotide treatment does not improve efficacy of aspiration sclerotherapy. • Cyst fluid reaccumulation after aspiration sclerotherapy is a transient phenomenon. • Aspiration sclerotherapy strongly reduces symptoms and normalizes quality of life. [ABSTRACT FROM AUTHOR]

Background: Most individuals with depression do not receive adequate treatment. Internet interventions may help to bridge this gap. Research on attitudes toward Internet interventions might facilitate the dissemination of such interventions by identifying factors that help or hinder uptake and implementation, and by clarifying who is likely to benefit. This study examined whether attitudes toward Internet interventions moderate the effects of a depression-focused Internet intervention, and how attitudes change over the course of treatment among those who do or do not benefit.Methods: We recruited 1,004 adults with mild-to-moderate depression symptoms and investigated how attitudes toward Internet interventions are associated with the efficacy of the program deprexis, and how attitudes in the intervention group change from pre to post over a 3 months intervention period, compared to a control group (care as usual). This study consists of a subgroup analysis of the randomized controlled EVIDENT trial.Results: Positive initial attitudes toward Internet interventions were associated with greater efficacy (η2p  = .014) independent of usage time, whereas a negative attitude (perceived lack of personal contact) was associated with reduced efficacy (η2p  = .012). Users' attitudes changed during the trial, and both the magnitude and direction of attitude change were associated with the efficacy of the program over time (η2p  = .030).Conclusions: Internet interventions may be the most beneficial for individuals with positive attitudes toward them. Informing potential users about evidence-based Internet interventions might instill positive attitudes and thereby optimize the benefits such interventions can provide. Assessing attitudes prior to treatment might help identify suitable users. [ABSTRACT FROM AUTHOR]

Objective: New interventions supporting health literacy and a tobacco-free lifestyle in adolescence are needed to narrow the widening gap in existing health inequalities. Health games offer potential and could be utilized for example in school healthcare, but more research is needed to increase the understanding of the effects of game elements in health interventions. The aim of this feasibility study is to determine the short-term effectiveness of the tobacco-related mobile health game Fume and a non-gamified website in comparison with a no-intervention control group, regarding tobacco-related health literacy among 10-13-year-old early adolescents. In addition, we compare the demand for and acceptability of Fume to that of the website.Methods: In total, 151 early adolescents participated in this single-blinded, three-armed cluster randomized trial. The participants from three municipalities in southwest Finland were randomly allocated between a group with access to the health game Fume (n = 61), a group with access to the website (n = 47), and a group with no intervention (n = 43). The intervention groups first participated in a 20-min training session with Fume/the website, and then had two weeks to use Fume/the website based on their own interest. Short-term effectiveness was measured by primary (anti-smoking self-efficacy) and secondary (smoking outcome expectations, attitudes towards tobacco use, tobacco-use motives, motivation to decline tobacco use in the future, and knowledge about tobacco) outcomes derived from the theory-based determinants of tobacco-related health literacy and evaluated with self-assessment questionnaires at baseline and post-intervention (after a two-week follow-up). For evaluating the demand, the actual use of Fume/the website was tracked during the two-week period. Regarding acceptability, the raised interest towards Fume/the website and opinions about the interventions were evaluated post-intervention. Differences were tested with the McNemar, Fisher exact, and non-parametric tests.Results: Statistically significant favorable changes during the study period were found for positive (P = 0.002) and negative (P = 0.02) smoking outcome expectations and attitudes towards cigarette smoking (P = 0.01) within the group using Fume. No statistically significant changes were detected within the website or control groups. Statistically significant differences were not found for the change in outcome variables among the three groups. The number of visits (P < 0.001), number of separate visit days (P < 0.001) and total duration of use (P < 0.001) were larger for the group using Fume than for that using the website. Fume sparked more interest in early adolescents than the website did (P <  0.001). There were no statistically significant differences in opinions about Fume and those regarding the website.Conclusions: The intervention with embedded game elements, the health game Fume, was found to be more feasible as a tobacco-related health education intervention than the non-gamified website among early adolescents in light of demand and acceptability (raised interest). Even though no change in anti-smoking self-efficacy was found, the results of this feasibility study demonstrated favorable short-term changes with Fume in some other theory-based determinants of tobacco-related health literacy. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate whether exposure to MyFamilyPlan-a web-based preconception health education module-changes the proportion of women discussing reproductive health with providers at well-woman visits.Design: Cluster randomized controlled trial. One hundred thirty participants per arm distributed among 34 clusters (physicians) required to detect a 20% change in the primary outcome.Setting: Urban academic medical center (California).Participants: Eligible women were 18 to 45 years old, were English speaking, were nonpregnant, were able to access the Internet, and had an upcoming well-woman visit. E-mail and phone recruitment between September 2015 and May 2016; 292 enrollees randomized.Intervention: Intervention participants completed the MyFamilyPlan module online 7 to 10 days before a scheduled well-woman visit; control participants reviewed standard online preconception health education materials.Measures: The primary outcome was self-reported discussion of reproductive health with the physician at the well-woman visit. Self-reported secondary outcomes were folic acid use, contraceptive method initiation/change, and self-efficacy score.Analysis: Multilevel multivariate logistic regression.Results: After adjusting for covariates and cluster, exposure to MyFamilyPlan was the only variable significantly associated with an increase in the proportion of women discussing reproductive health with providers (odds ratio: 1.97, 95% confidence interval: 1.22-3.19). Prespecified secondary outcomes were unaffected.Conclusion: MyFamilyPlan exposure was associated with a significant increase in the proportion of women who reported discussing reproductive health with providers and may promote preconception health awareness; more work is needed to affect associated behaviors. [ABSTRACT FROM AUTHOR]

Background Clinical observations and results from recent studies support the use of non-invasive vagus nerve stimulation (nVNS) for treating cluster headache (CH) attacks. This study compared nVNS with a sham device for acute treatment in patients with episodic or chronic CH (eCH, cCH). Methods After completing a 1-week run-in period, subjects were randomly assigned (1:1) to receive nVNS or sham therapy during a 2-week double-blind period. The primary efficacy endpoint was the proportion of all treated attacks that achieved pain-free status within 15 minutes after treatment initiation, without rescue treatment. Results The Full Analysis Set comprised 48 nVNS-treated (14 eCH, 34 cCH) and 44 sham-treated (13 eCH, 31 cCH) subjects. For the primary endpoint, nVNS (14%) and sham (12%) treatments were not significantly different for the total cohort. In the eCH subgroup, nVNS (48%) was superior to sham (6%; p < 0.01). No significant differences between nVNS (5%) and sham (13%) were seen in the cCH subgroup. Conclusions Combing both eCH and cCH patients, nVNS was no different to sham. For the treatment of CH attacks, nVNS was superior to sham therapy in eCH but not in cCH. These results confirm and extend previous findings regarding the efficacy, safety, and tolerability of nVNS for the acute treatment of eCH. [ABSTRACT FROM AUTHOR]

Background: Recent evidence has highlighted the prevalence of mild-to-moderate iodine deficiency in women of childbearing age and pregnant women, with important public health ramifications due to the role of iodine, which is required for thyroid hormone production, in neurodevelopment. Cow milk contributes the greatest amount to iodine intakes in several countries.Objective: The objective of this study was to investigate the effect of increased cow milk consumption on iodine status, thyroid hormone concentrations, and selenium status.Methods: A 12-wk randomized controlled trial was conducted in 78 low-moderate milk-consuming (<250 mL/d) healthy women (aged 18-45 y). The intervention group was asked to consume 3 L semiskimmed milk/wk, whereas the control group continued their usual milk consumption (baseline median: 140 mL/d; IQR: 40-240 mL/d). At baseline and weeks 6 and 12, participants provided a spot urine sample [urinary iodine concentration (UIC), creatinine] and a fasting blood sample (thyroid hormone concentrations, serum total selenium, selenoprotein P).Results: At baseline, the median (IQR) UIC of all participants was 78.5 µg/L (39.1-126.1 µg/L). Changes in the median UIC from baseline to week 6 (35.4 compared with 0.6 µg/L; P = 0.014) and week 12 (51.6 compared with -3.8 µg/L; P = 0.045) were significantly greater in the intervention group compared with the control group. However, despite being higher within the intervention group at weeks 6 and 12, the change in the iodine:creatinine ratio from baseline was not significantly different between groups at either week 6 (P = 0.637) or week 12 (P = 0.178). There were no significant differences in thyroid hormone concentrations or selenium status between groups at any time point.Conclusions: The present study shows that the consumption of additional cow milk can significantly increase UIC in women of childbearing age. These results suggest that cow milk is a potentially important dietary source of iodine in this population group. This trial was registered at www.clinicaltrials.gov as NCT02767167. [ABSTRACT FROM AUTHOR]

Purpose: To examine the effects of a free-living, sedentary-inducing intervention on cognitive function.Design: Randomized controlled, parallel group intervention.Setting: University campus.Participants: Thirty-three young adults (n = 23 intervention; n = 10 control).Measures: The intervention group was asked to eliminate all exercise and minimize steps to ≤5000 steps/day for 1 week, whereas the control group was asked to continue normal physical activity (PA) levels for 1 week. Both groups completed a series of 8 cognitive function assessments (assessing multiple parameters of cognition) preintervention and immediately postintervention. The intervention group was asked to resume normal PA levels for 1 week postintervention and completed the cognitive assessments for a third time at 2 weeks postintervention.Analysis: Split-plot repeated-measures analysis of variance.Results: The results of our statistical analyses showed that the group × time interaction effect was not significant ( P > .05) for any of the evaluated cognitive parameters.Conclusion: These findings demonstrate the need for future experimental investigations of sedentary behavior to better understand its effects on cognitive function. However, although previous work has demonstrated favorable effects of acute and chronic PA on cognitive function, our findings suggest that a 1-week period of reduced PA does not detrimentally affect cognitive function, which may have encouraging implications for individuals going through a temporary relapse in PA. [ABSTRACT FROM AUTHOR]

Background: Although self-efficacy is a potential determinant of feeding and care behaviors, there is limited empirical analysis of the role of maternal self-efficacy in low- and middle-income countries. In the context of behavior change interventions (BCIs) addressing complementary feeding (CF), it is possible that maternal self-efficacy can mediate or enhance intervention impacts.Objective: In the context of a BCI in Bangladesh, we studied the role of maternal self-efficacy for CF (MSE-CF) for 2 CF behaviors with the use of a theoretically grounded empirical model of determinants to illustrate the potential roles of MSE-CF.Methods: We developed and tested a locally relevant scale for MSE-CF and included it in a survey (n = 457 mothers of children aged 6-24 mo) conducted as part of a cluster-randomized evaluation. Qualitative research was used to inform the selection of 2 intervention-targeted behaviors: feeding green leafy vegetables in the last 24 h (GLV) and on-time introduction of egg (EGG) between 6 and 8 mo of age. We then examined direct, mediated, and potentiated paths of MSE-CF in relation to the impacts of the BCI on these behaviors with the use of regression and structural equation modeling.Results: GLV and EGG were higher in the intensive group than in the nonintensive control group (16.0 percentage points for GLV; P < 0.001; 11.2 percentage points for EGG; P = 0.037). For GLV, MSE-CF mediated (β = 0.345, P = 0.010) and potentiated (β = 0.390, P = 0.038) the effect of the intensive group. In contrast, MSE-CF did not mediate or potentiate the effect of the intervention on EGG.Conclusions: MSE-CF was a significant mediator and potentiator for GLV but not for EGG. The divergent findings highlight the complex determinants of individual specific infant and young child feeding behaviors. The study shows the value of measuring behavioral determinants, such as MSE-CF, that affect a caregiver's capability to adopt intervention-targeted behaviors. [ABSTRACT FROM AUTHOR]

Attention bias for pain-related information is theorised to maintain chronic pain, indicating that changing this bias could improve pain-related outcomes. Modifying attention biases in adolescents, when chronic pain often first emerges, may be particularly beneficial. We report here a randomized, placebo-controlled, parallel-group trial of attention bias modification (ABM) training in adolescents with chronic noncancer pain. Adolescent patients (N = 66) were randomly assigned to complete multiple sessions of dot-probe ABM training (N = 23), placebo training (N = 22), or no training (waitlist; N = 21) across a period of 4 weeks. Patients completed all assessments at a hospital-based pediatric pain clinic and completed all training at home. We examined the relative effects of ABM on attention bias and attention control, as well as pain symptomatology (primary outcome), pain catastrophizing, anxiety and depression symptoms, and functional disability (secondary outcomes) immediately after training and 3 months later. We found no evidence that ABM changed attention bias or attention control in comparison with placebo training or no training. We also found that pain and pain-related outcomes were no different for those undergoing ABM compared with placebo training or no training when tested immediately after training or 3 months later. Overall, we found no evidence to support the efficacy of dot-probe ABM for improving pain-related outcomes in adolescents with chronic pain. This study was registered on the NIHR Clinical Research Network Portfolio in August 2014 (UK Clinical Trials Gateway: CPMS 17251) and funded by a Research Training Fellowship awarded to Lauren Heathcote by Action Medical Research for Children. [ABSTRACT FROM AUTHOR]