Search

Evidence suggests that adapting teaching responsively to pupil assessment can be effective in improving students' learning. However, existing studies tend to be small-scale, leaving unanswered the question of how such formative assessment can operate when embedded as standard practice. In this study, we present the results of a randomized trial conducted in 140 English secondary schools. The intervention uses light-touch training and support, with most of the work done by teacher-led teaching and learning communities within schools. It is, therefore, well-suited to widespread adoption. In our pre-registered primary analysis, we estimate an effect size of 0.09 on general academic attainment in national, externally assessed examinations. Sensitivity analysis, excluding schools participating in a similar program at baseline, and complier analysis both suggest a larger effect size of 0.11. These results are encouraging for this approach to improving the implementation of formative assessment and, hence, academic attainment. Our findings also suggest that the intervention may help to narrow the gap between high and low prior attainment pupils, although not the gap between those from disadvantaged backgrounds and the rest of the cohort. [ABSTRACT FROM AUTHOR]

To compare the effects of Kinesio taping® (KT) and external electrical stimulation (ES) in addition to pelvic floor muscle exercise (PFME) and sole PFME in women with overactive bladder (OAB). Patients with OAB were randomly allocated into PFME, PFME + KT, PFME + ES groups. All treatments were carried out for 6 weeks. OAB symptoms with voiding diary and Overactive Bladder-Version8 (OAB-V8), pelvic floor muscle strength (PFMS) with perineometer, quality of life with King's Health Questionnaire (KHQ) were assessed before (BT) and after treatment (AT). AT, the perception of improvement was inquired. AT, OAB symptoms and KHQ scores decreased and PFMS improved in all groups (p < 0.05). The intergroup comparisons revealed a further decrease in voids/day, voids/night, OAB-V8, and some KHQ scores, and a further increase in the perception of improvement in the PFME + KT and PFME + ES groups compared to the PFME group (p < 0.05). In the PFME + ES group, there was a further decrease in numbers of incontinence compared to the PFME group, and in severity measures scores compared to the other groups (p < 0.05). KT and external ES in addition to PFME were more effective than PFME alone in the treatment of OAB. Pelvic floor muscle exercise was found to be effective in reducing overactive bladder symptoms and increasing quality of life. Kinesio taping or external electrical stimulation in addition to pelvic floor muscle exercise is more effective in improving overactive bladder symptoms, quality of life, and perception of improvement than pelvic floor muscle exercise alone. Kinesio taping and external electrical stimulation can be used as a complementary application in the treatment of overactive bladder. Pelvic floor muscle exercise, pelvic floor muscle exercise + Kinesio taping, and pelvic floor muscle exercise + electrical stimulation applications should be included in conservative treatment options in patients with overactive bladder to reduce symptoms and cost, and improve quality of life. [ABSTRACT FROM AUTHOR]

The current situation due to the COVID-19 pandemic has had huge consequences in all aspects of our lives, including the development of research activities. Studies involving face-to-face interaction with people, such as randomized controlled trials, were the first affected. The objective of this article is to present the insights on challenges brought by the COVID-19 pandemic onto an ongoing randomized controlled trial assessing a non-pharmacological intervention carried out with the participation of caregiver-child dyads. Findings contribute to the scarce literature on online synchronous data collection for quantitative studies, when in addition to the data it is necessary to assess observable behaviors. Video-conferencing proved to be a feasible alternative to face-to-face assessment interviews, which require video recording, and should be considered as a viable option for quantitative investigations of different disciplines, as it decreases risks due to face-to-face contact and mobility of participants and researchers, in continental countries like Brazil. [ABSTRACT FROM AUTHOR]

Objectives. The increasing prevalence of musculoskeletal disorders (MSDs), especially in the neck and upper limbs, among office workers is an important issue related to health and job productivity. The present study aimed to evaluate the effect of an ergonomics training intervention on MSDs, quality of work-life and occupational psychosocial stresses among office workers. Methods. This quasi-randomized trial study was conducted in Isfahan, Iran in 2019. Outcome measures were measured in a follow-up period of 1, 3 and 6 months after the intervention. The results were analyzed using repeated-measures analysis of variance. Results. The interventions performed had a significant effect on neck, left shoulder, right wrist and left thigh discomfort. These interventions also had a significant effect on social support and physical job demands. Significant changes were detected in quality of work-life, chance of growth and security, social integration in organization and social relevance of work in life, although these changes decreased in quality of work-life. No significant differences were detected in the other measured outcomes. Conclusion. The implementation of ergonomic interventions was effective in reducing MSDs in the neck and upper limbs. It is recommended to conduct continuous training courses to control the risk of ergonomic factors affecting body discomfort. [ABSTRACT FROM AUTHOR]

To compare maternal and perinatal outcomes between randomized trials and observational studies in which conservative management was performed for more than 48 h in patients with early-onset severe preeclampsia. We searched PubMed, LILACS, Cochrane and Google Scholar. The studies were divided in two groups: randomized and observational studies, from 1990 to 2018 that included patients with severe preeclampsia before 34 weeks of gestation with pregnancy prolongation ≥48 h but that did not include fetal growth restriction or HELLP syndrome at the beginning. The main variables recorded were maternal and perinatal complications. Forty-four studies met the inclusion criteria, and 5 of these were randomized. The average pregnancy prolongation was 9 days, with no difference between groups. Maternal complications were significantly more common in observational studies, RR = 0.71, 95% CI (0.54–0.93), p =.009. Perinatal complications were also significantly more common in observational studies (RR = 0.89, 95% CI (0.80–0.98), p =.01) at the expense of stillbirth and neonatal deaths. The percentages of cesarean sections were significantly higher in randomized studies, RR = 1.54, 95% CI (1.46–1.64). There were 2 maternal deaths, both in observational studies. Observational studies in which conservative management of early-onset preeclampsia is performed and do not include patients with fetal growth restriction or patients with HELLP syndrome and where at least 2 days of pregnancy prolongation is achieved are associated with significantly more maternal and perinatal complications. [ABSTRACT FROM AUTHOR]

Traumatic brain injury (TBI) causes deficits in executive function (EF), as well as problems in behavioural and emotional self-regulation. Neurological music therapy may aid these aspects of recovery. We performed a cross-over randomized controlled trial where 40 persons with moderate-severe TBI received a 3-month neurological music therapy intervention (2 times/week, 60 min/session), either during the first (AB, n = 20) or second (BA, n = 20) half of a 6-month follow-up period. The evidence from this RCT previously demonstrated that music therapy enhanced general EF and set shifting. In the current study, outcome was assessed with self-report and caregiver-report questionnaires performed at baseline, 3-month, 6-month, and 18-month stages. The results showed that the self-reported Behavioural Regulation Index of the Behaviour Rating Inventory of Executive Function (BRIEF-A) improved more in the AB than BA group from baseline to 3-month stage and the effect was maintained in the 6-month follow-up. No changes in mood or quality of life questionnaires were observed. However, a qualitative content analysis of the feedback revealed that many participants experienced the intervention as helpful in terms of emotional well-being and activity. Our results suggest that music therapy has a positive effect on everyday behavioural regulation skills after TBI. [ABSTRACT FROM AUTHOR]

This systematic review and meta-analysis of randomized controlled trials (RCTs) examined effects of mindfulness- and acceptance-based interventions (MABIs) on quality of life (QoL), coping, cognition, and mindfulness among people with multiple sclerosis (MS). Four electronic databases were searched to 3 July 2020. Data was combined in a random-effects meta-analysis model. Eighteen RCTs met the eligibility criteria. Meta-analyses at the immediate posttest found: moderate effects of MABIs on QoL, coping, and attention; and a large effect on memory. A large effect of MABIs on QoL was found at follow-up. There was no significant effect of MABIs on mindfulness. Relatively fewer studies in outcomes other than QoL were found, and the overall risk of bias across the included 18 RCTs was unclear. Future high-quality studies with follow-up evaluations are needed to support effects of MABIs on QoL, coping, cognition, and mindfulness in people with MS and examine intervention features that increase and maintain effects. [ABSTRACT FROM AUTHOR]

Early mobilization is believed to be helpful for patients with acute ischemic stroke. This study aimed to compare the difference between starting rehabilitation between 24 and 48 h and 72 and 96 h following the onset of ischemic stroke. This was a single-center, single-blind, randomized controlled trial. The early rehabilitation (ER) group started exercising between 24 and 48 h after stroke onset, which the standard rehabilitation (SR) group started exercising between 72 and 96 h. The two groups received sitting, standing, and repetitive body strength training respectively. In this study, 110 patients were analyzed. Patients in the early rehabilitation group had more favorable outcomes (The modified Rankin scale score 0-2, ER group = 32 versus SR group = 20, adjusted odds ratio 2.27, 95% CI 1.05-4.87; p = 0.036) at 3-month follow-up. The simplified Fugl–Meyer assessment (FMA) scores for the lower extremity were influenced by the interaction effect (F = 7.24, p = 0.01). The post-hoc analysis revealed a difference in the lower extremity FMA score at one week after stroke (difference 2.30 (95% CI 0.65–3.96); p = 0.007). Early physical rehabilitation training between 24 and 48 h may be beneficial and improve patients' lower extremity function within the first week. NCT02718534 Acute ischemic stroke has a variety of symptoms, and acroparalysis is a major concern. Starting physical rehabilitation early can improve the prognosis of patients with ischemic stroke. Early rehabilitation is more conducive to the recovery of lower extremity motor function, but in the subsequent rehabilitation process, the upper extremity function should be paid more attention. [ABSTRACT FROM AUTHOR]

Fertility awareness (FA) among young people is low. Fertility awareness interventions have been found to contribute to increase FA in the short-term. The long-term effectiveness of FA interventions on childless and presumed fertile people, committed in a heterosexual relationship and wishing to have children in the near future is not known. In a double-blind parallel randomized controlled trial conducted between 2016 and 2018, 652 childless partnered women were randomized to either watch a 5-min video about fertility (IG: 'Intervention Group') or to not receive any intervention (CG: 'Control Group'). Participants filled out an online questionnaire at the start of the study (and in the IG group immediately before intervention). They then completed the questionnaire after 1 month, 6 months and 1 year. The questionnaire assessed FA and intentions to adopt fertility-protective behaviours. In the IG, FA levels were found to increase at 1 month post-intervention. However, significant interaction effects between group and time were only found for four out of the seven FA variables at the 6-month and 1-year follow-up. No effects were found for: (i) intentions to adopt fertility-protective behaviours; or (ii) desired timing of pregnancy. These results suggest that the fertility video intervention seems to partially increase FA in the long term. Future studies should investigate the effectiveness of different intervention formats with a focus on overcoming high attrition rates. [ABSTRACT FROM AUTHOR]

Positive Psychology Interventions (PPIs) have been shown to improve mental health, but little is known about their impact on the quantifiable experience of flourishing. Two experimental studies investigated whether the proportion of participants flourishing, assessed using the Huppert and So conceptual framework, could be increased through a 10-week online interdisciplinary intervention that combined strategies from positive psychology and lifestyle medicine. In Study 1 (n = 421), flourishing was significantly increased (p < 0.001) in the intervention but not the control group and was sustained at 12 weeks post-intervention. Study 2 (n = 458) showed that the addition of human support to the online intervention did not further improve its effectiveness at increasing flourishing. These studies demonstrate that online interdisciplinary interventions that incorporate positive psychology and lifestyle medicine strategies can increase human flourishing, irrespective of the addition of human support. [ABSTRACT FROM AUTHOR]

This pilot randomised controlled trial evaluated the acceptability and feasibility of a psychological intervention to manage severe irritability in children and adolescents. Children with severe irritability (9–14 years; 42% male) were randomised to receive six sessions of Collaborative & Proactive Solutions (CPS) or usual clinical care. The primary outcome was acceptability and feasibility of the intervention (participant enrollment, drop-out, intervention session attendance). Key secondary outcomes assessed 4-month post-randomisation included child irritability, quality of life, executive functioning, parent mental health and family functioning. Twelve children enrolled in the study (52% uptake). All participants in the CPS group attended ≥2 intervention sessions, and one participant in the usual care group was lost to follow-up. Compared to usual care, the CPS group had improvements in child irritability (Effect Size (ES): −0.4), quality of life (ES: 0.4), executive functioning (ES: −0.4), and family functioning (ES: −0.7). It is acceptable and feasible to deliver CPS to severely irritable children and adolescents. Preliminary evidence suggests this non-pharmacological intervention improves important areas of functioning for severely irritable children. The trial was prospectively registered on 11 October 2017 with the Australian New Zealand Clinical Trials Registry (: ACTRN12617001445369). [ABSTRACT FROM AUTHOR]

Auriculotherapy has been used to reduce withdrawal symptoms during drug detoxication. The purpose of this study was to review the results of the randomized controlled trials (RCTs) that examined the impact of auriculotherapy on addiction. This study aimed to find an effective protocol involving auricular acupuncture points, intervention duration and frequency, and stimulating methods. We searched PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Medline for articles published between January 1, 1994, and March 31, 2021. The keywords used were auricular, acupuncture, addiction, substance misuse, smoking, randomized controlled trial, clinical trial, and human. Each RCT was evaluated for quality applying the risk of bias tool by the Cochrane group. Effect size (Hedges's g) was calculated using the mean values and standard deviation of the experimental and control groups. The risk for bias of these studies was moderate to high and only four studies (11.1%) earned scores of 6, indicating the lowest risk of bias and highest quality RCT. Out of 36 studies, 23 (64%) reported that auriculotherapy was effective for treating addiction such as opioids, cocaine, alcohol, heroin, nicotine, and gambling. The most commonly used combination of acupuncture points (four of 36 studies) was shenmen, sympathetic, liver, lung, and kidney, which are called NADA protocol. The following most frequently used combination of acupressure points (four out of 36 studies) was shenmen, subcortex, heart, lung, and liver. Acupressure could be considered to be used for the treatment of addiction. [ABSTRACT FROM AUTHOR]

To evaluate the effect of a rapid treatment protocol of low-level laser therapy (LLLT) in patients with myofascial pain and mouth opening limitation. Twenty patients were randomly allocated into the laser group (LG) (n = 10) and the placebo group (PG) (n = 10). Two LLLT sessions or placebo were performed. They were applied to the pain points upon palpation, with a 48-hr interval. Patients were evaluated for spontaneous pain sensitivity during mandibular movements and for oral health-related quality of life, which was assessed using the Oral Health Impact Profile for Temporomandibular Disorders (OHIP/TMD) questionnaire. Two patients from the placebo group were lost during the study. A significant increase in the maximum mouth opening (p = 0.04) and improvement in OHIP/TMD scores (p = 0.003) were observed in the LG after 30 days. Spontaneous pain was reduced in both groups with low-level laser therapy. [ABSTRACT FROM AUTHOR]

Positive emotions have been found to be analgesic and can be induced by positive psychology exercises. This study tested if positive psychology exercises provide beneficial effects on pain, responses to pain, physical (pain interference), and emotional function. Randomized parallel-group controlled single-blinded superiority-trial including community-dwelling individuals with chronic pain secondary to spinal cord injury. Participants in the intervention group were instructed to practice 4 personalized positive psychology exercises for 8 weeks. Participants in the control group were asked to be mindful and write about current life events. 108 (64%) completed the study. At post-treatment, the intervention participants reported significant reductions in pain intensity and improvements in pain catastrophizing and pain control, relative to baseline. Both groups reported significant decreases in pain interference and negative emotions. Significant between-group differences emerged for pain intensity at post-treatment. At 3-months follow-up, improvements maintained for the intervention group and improvements in positive emotions reached statistical significance. Between-group differences were identified for pain intensity at post-treatment. Positive psychology exercises represent a potential effective complementary treatment that result in benefits on pain which can be readily implemented into daily living. Trials designed with an inactive control condition should be conducted to further address efficacy. Swiss ethics committee (EKNZ 2014-317)/clinicaltrials.gov (NCT02459028) Registration date: Ethics approval 25.10.2014/Study start date: May 2015 URL of the record: Pain engenders negative emotions (e.g., fear, anger, sadness) which can negatively affect psychological, social, and physical function. Positive emotions have been found to be analgesic and can be induced by practicing positive psychology exercises. The findings of the current randomized controlled trial provide support for practicing positive psychology exercises (beyond the effects of pain medication intake), in particular on the reduction of pain intensity, but also in improving pain catastrophizing and pain control. The majority of the positive psychology exercises are brief and self-administered positive activities that have no known negative side effects nor financial cost, can be tailored to a person's preferences in activities and can be readily implemented into daily living with chronic pain, complementing standard treatment of pain. [ABSTRACT FROM AUTHOR]

This study investigated symptom change trajectory for patients with persistent somatic symptoms (PSS) during psychotherapy and the association of these patterns with pre-treatment characteristics and long-term outcome. Growth mixture modeling was used to identify trajectory curves in a sample of N = 210 outpatients diagnosed with PSS and treated either with conventional cognitive behavioral therapy (CBT) or CBT enriched with emotion regulation training (ENCERT). We identified three subgroups of patients with similar symptom change patterns over the course of treatment (a "no change," "strong response," and "slow change" subgroup). Higher initial anxiety symptoms were significantly associated with the no change and strong response subgroups; symptom-related disability in daily routine with no changes. Patients with a strong response had the highest proportion of reliable improvement at termination and at six-month-follow-up. Our results indicate that, instead of one common change pattern, patients with PSS respond differently to treatment. Due to the high association of symptom curves with long-term outcome, the identification and prediction of an individual's trajectory could provide important information for clinicians to identify non-responding patients that are at risk for failure. Selecting personalized treatment interventions could increase the effectiveness of psychotherapy. Trial registration: ClinicalTrials.gov identifier: NCT01908855.. [ABSTRACT FROM AUTHOR]

This article examines outcomes of the first randomized controlled trial of Regulation Focused Psychotherapy for Children (RFP-C), a manualized, short-term, psychodynamic intervention for decreasing symptoms of the oppositional defiant disorder (ODD) in school-aged children. Participants (n = 43) were school-aged children who were randomly assigned to RFP-C or a waitlist control group. Symptoms of ODD and explicit emotion regulation capacities were assessed at baseline, end of waitlist, and end of treatment. Multilevel modeling was used to account for patient and therapist factors in outcomes. At the end of treatment, parents reported significant reductions in children's ODD symptoms on the primary outcome measure. There were no observed changes in explicit emotion regulation. Reliable change index scores indicated that 79.4% of children were recovered or improved after 10 weeks of treatment. There were no identifiable patient or therapist effects. Treatment adherence and completion was high. This study is the first randomized controlled trial of a manualized psychodynamic intervention for children with ODD. Participants demonstrated significant reductions in symptoms of ODD after 10 weeks of treatment. Further investigation is needed to compare RFP-C relative to active treatment, assess changes in implicit emotion, and to determine long-term maintenance of symptom improvement. Clinical trial registration information: Evaluation of Regulation Focused Psychotherapy for Children (RFP-C); [ABSTRACT FROM AUTHOR]

The immunogenicity of hepatitis B vaccine is unsatisfactory in the people living with HIV (PLHIV). Studies evaluating optimal regimens to enhance immunogenicity have heretofore been inconclusive. The study was to compare the immunogenicity and safety of the four standard-dose and high-dose regimens of hepatitis B vaccine among PLHIV. A randomized, parallel-controlled trial was conducted between May, 2020, and January, 2021. Patients were randomly assigned to receive 3 or 4 doses of 20 or 60 µg of hepatitis B vaccine. Seroconversion rate, high-level response rate, and geometric mean concentration (GMC) of antibody to hepatitis B surface antigen (anti-HBs) at weeks 12 and 28 were the main outcome measures. At week 28, the seroconversion rate and GMC of anti-HBs in both IM20 × 4 and IM60 × 4 groups were significantly higher than those in the IM20 × 3 group (P < 0.05), and the GMC of anti-HBs was numerically higher in the IM60 × 4 group than that in the IM20 × 4 group. In PLHIV, both the four standard-dose and high-dose regimens significantly improved immunogenicity. The GMC of anti-HBs was numerically higher in the IM60 × 4 group than that in the IM20 × 4 group. ClinicalTrials.gov (NCT03962803) [ABSTRACT FROM AUTHOR]

Previous studies have demonstrated that ursodeoxycholic acid (UDCA) possesses anti-inflammatory, antioxidant, and anti-fibrotic properties, and it may reduce the degree of liver damage caused by nonalcoholic steatohepatitis (NASH). However, the effectiveness of UDCA in improving liver function and histology in cases of NASH remains unclear. Therefore, we performed a meta-analysis to assess the efficacy of UDCA in the treatment of NASH. PubMed, Web of Science, Embase, Cochrane, and other databases were searched for randomized controlled trials (RCTs) published before 1 January 2022, in which UDCA was used to treat patients with NASH. A total of 8 studies with 655 participantsmet the criteria for inclusion in this meta-analysis. The forest plot displayed that UDCA treatment significantly reduced blood concentrations of alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT). However, the pooled effect size results did not suggest any significant effect of UDCA on anthropometric characteristics or hepatic histology. UDCA therapy can effectively reduce serum levels of ALT and GGT in patients with NASH but has no significant effects on physical characteristics or liver histology. Further large-scale and dose-response clinical studies are needed to evaluate the clinical potential of UDCA in treating NASH. [ABSTRACT FROM AUTHOR]

Vitamin D levels have been reported to be associated with COVID-19 susceptibility, severity, and mortality events. We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the use of vitamin D intervention on COVID-19 outcomes. Literature search was conducted using PubMed, Cochrane library, and ClinicalTrials.gov databases. We included RCTs reporting the use of vitamin D intervention to control/placebo group in COVID-19. The study was registered at PROSPERO: CRD42021271461. A total of 6 RCTs with 551 COVID-19 patients were included. The overall collective evidence pooling all the outcomes across all RCTs indicated the beneficial use of vitamin D intervention in COVID-19 (relative risk, RR = 0.60, 95% CI 0.40 to 0.92, Z = 2.33, p = 0.02, I2 = 48%). The rates of RT-CR positivity were significantly decreased in the intervention group as compared to the non-vitamin D groups (RR = 0.46, 95% CI 0.24 to 0.89, Z = 2.31, p = 0.02, I2 = 0%). Conclusively, COVID-19 patients supplemented with vitamin D are more likely to demonstrate fewer rates of ICU admission, mortality events, and RT-PCR positivity. [ABSTRACT FROM AUTHOR]

Translation of findings from stroke trials into clinical practice remains low. Little is known about planned translation activities from the perspective of trialists who generate the evidence. This study aims to investigate perceptions of Australian stroke clinical trialists' about implementation of their findings into practice, and what translation activities they embedded into trial protocols. A descriptive cohort design and electronic survey was conducted. Three databases were searched to identify Australian stroke rehabilitation trials published between 2007 and 2017. Corresponding authors of the included trials were invited to complete an anonymous online survey about implementation of their trial intervention. Fifty-one trialists were invited to participate and 38 completed the survey (74% response rate). The majority (79%) considered their trial results to be clinically significant and 68% had pre-planned knowledge translation activities. The most common planned translation activities were publication (89%), conference presentation (87%), and feedback of results to target audiences (58%). Mixed opinions were evident regarding when and how to design knowledge translation activities for inclusion in trial protocols. Stroke rehabilitation trialists rely mostly on anecdotal reports about implementation of trial interventions, with few formally measuring uptake. The most common knowledge translation activities planned for by researchers are publication of findings in academic journals, and conference presentations. Mixed opinions exist regarding when and how to design for knowledge translation activities in trial protocols. Limited formal measurement of intervention uptake is completed. Further implementation research is required to support and measure effective translation efforts when embedded into trial protocols. [ABSTRACT FROM AUTHOR]

Background: Social cognition is an independent structure from the positive symptoms of schizophrenia and contributes to negative symptoms, neurocognitive impairment, and social functioning. Aim: To examine the effectiveness of the metacognitive training intervention on social cognition in people with schizophrenia. Design: This study was conducted as a randomized quasi-experimental (pre-test/post-test and followup) design with a control group. Methods: Thirty-nine patients with schizophrenia were enrolled and randomly assigned to either the control group (n=19) or the metacognitive training group (n=20). A 10-week metacognitive training program was offered to the intervention group. The study involved a pre-test/post-test design with a 3-month follow-up assessment. The primary outcome was social cognition, as measured by the Facial Emotion Discrimination/Identification Tests, Reading the Mind in the Eyes Test, and Attributional Style Questionnaire. The secondary outcome was measured by the metacognitive training subjective efficacy form. Results: Completion at follow-up was high (92.3%). The results show that the changes over time in the False Belief Task 1st level, Attributional Style Questionnaire negative events global-specific dimension, and positive events stable-unstable dimension mean scores, time interaction, were statistically significant. Metacognitive Training was efficacious on the theory of mind and in performing more functional attributions. Patients in the intervention group showed high-level positive feedback. Conclusion: Metacognitive Training applied by psychiatric and mental health nurses demonstrated a user and practitioner-friendly, safe and effective program on social cognition. Also, the social and cultural feasibility and effectiveness of the Metacognitive Training program were shown for the first time in a Turkish population. [ABSTRACT FROM AUTHOR]

Brief transdiagnostic psychotherapy is a possible approach for emotional disorders in primary care. The objective of the present randomized controlled trial was to determine its effectiveness compared with the treatment as usual based on pharmacological interventions in patients with mild/moderate symptoms. In addition, emotional regulation strategies and cognitive factors were studied as potential predictors. Participants (N = 105) were assigned to brief group therapy based on the Unified Protocol (n = 53) or treatment as usual (n = 52). They were assessed before and after the interventions. Mean differences and stepwise regression analyses were performed. Brief group transdiagnostic psychotherapy was more effective than medication in reducing all clinical symptoms (p =.007 for generalized anxiety; p =.000 for somatization; p =.000 for panic disorder; and p =.041 for depression) and in modifying emotional regulation strategies and cognitive processes (p =.000 for cognitive reappraisal, expressive suppression, worry, rumination, and metacognition) with moderate/high effect sizes. Besides, it was found that these variables acted as predictors of the therapeutic change. It is concluded that brief therapies could be an accurate treatment for mild/moderate emotional disorders in primary care due to their cost-effective characteristics. [ABSTRACT FROM AUTHOR]

Up to now, numerous randomized controlled trials (RCTs) have examined various drugs as possible treatments for Coronavirus Disease 2019 (COVID-19), but the results were diverse and occasionally even inconsistent with each other. To this point,we performed a systematic review and meta-analysis to assess the comparative effectiveness of pharmacological agents in published RCTs. A literature search was performed using PubMed, SCOPUS, EMBASE, and Web of Science databases. RCTs evaluating mortality and the average length of hospital stay to standard of care (SOC)/placebo/control were included. RCTs mainly were classified into five categories of drugs, including anti-inflammatory, antiviral, antiparasitic, antibody and antibiotics. Meta-analysis was done on 5 drugs classes and sub-group meta-analysis was done on single drugs and moderate or severe stage of disease. Mortality and the average length of hospital stay of COVID-19 patients were significantly reduced with anti-inflammatory drugs (odds ratio [OR]: 0.77, 95% confidence interval [CI]: 0.69 to 0.85, P<0.00001, and mean difference [MD]: −1.41, CI:-1.75 to −1.07, P<0.00001, respectively) compared to SOC/control/placebo. Furthermore, antiparasitic was associated with reduced length of hospital stay (MD: −0.65, CI: −1.26 to −0.03, P<0.05) in comparison to SOC/placebo/control. However, no effectiveness was found in other pharmacological interventions. [ABSTRACT FROM AUTHOR]

Cognitive decline is one of the greatest concerns for patients with Parkinson's disease (PD) and their care partners. Repetitive transcranial magnetic stimulation (rTMS) is a nonpharmacological treatment option used to improve cognitive function in PD, but its efficacy is unclear. We performed a meta-analysis to determine whether rTMS improves cognition in PD patients. Eligibility criteria (PICOS) were as follows: (1) 'P': The patients participating were diagnosed with idiopathic PD; (2) 'I': Intervention using rTMS; (3) 'C': Sham stimulation as control; (4) 'O': The outcome of the study included cognitive evaluations; (5) 'S': The study adopted randomized controlled design. The standardized mean difference (SMD) of change of score was applied to measure efficacy, and we used Version 2 of the Cochrane tool to assess risk of bias. Twelve studies met the inclusion criteria. Compared with sham-controlled group, the pooled result showed a non-significant short-term effect of rTMS on global cognition (SMD: −0.15, 95% CI: −0.59 to 0.29, I2 = 36.7%), executive function (SMD: 0.03, 95% CI: −0.21 to 0.26, I2 = 0.0%), and attention and working memory (SMD: 0.05, 95% CI: −0.25 to 0.35, I2 = 0.0%). Long-term outcomes were either shown to be statistically nonsignificant. Based on a limited number of studies, rTMS fails to improve cognition in PD. We call for additional high-quality randomized controlled trials with adequate sample sizes to determine the efficacy of rTMS. [ABSTRACT FROM AUTHOR]

Objective: The prevalence of migraine is higher in patients with gastrointestinal disorders. Possible underlying mechanisms could be increased intestinal permeability and systemic inflammation. Probiotics may reduce gut permeability as well as inflammation, and therefore may improve the clinical features of migraine. This systematic review and meta-analysis aimed to evaluate the impact of probiotic supplementation on the frequency and severity of migraine attacks. Methods: A systematic review of the literature was conducted using ISI Web of Science, PubMed/Medline, Scopus, Cochrane Library, EMBASE, Google Scholar, Magiran.com and Sid.ir to identify eligible studies published up to October 2019. A meta-analysis of eligible trials was performed using the random-effects model to estimate pooled effect size. Results: Three randomized controlled trials with 179 patients (probiotic group = 94, placebo group = 85) were included. Probiotic supplementation had no significant effect on frequency (weighted mean difference (WMD) = −2.54 attacks/month, 95%CI: −5.31–0.22, p = 0.071) and severity of migraine attacks (WMD = −1.23 visual analog scale (VAS) score, 95%CI = −3.37–0.92, p = 0.262) with significant heterogeneity among the studies (I2 = 98%, p < 0.001). Conclusions: A pooled analysis of available randomized controlled clinical trials showed that probiotic supplementation had no significant effect on the frequency and severity of episodic migraine attacks. [ABSTRACT FROM AUTHOR]

Background: There is insufficient study using Kinesio taping (KT) in bladder problems. Objectives: To investigate the effects of pelvic floor muscle training (PFMT) combined with KT on bladder symptoms, pelvic floor muscle strength, and quality of life in women with overactive bladder (OAB) syndrome and compare this combination with PFMT plus sham tape (ST). Methods: Women with OAB were randomly allocated into PFMT+KT and PFMT+ST groups. All patients were given PFMT for 6 weeks and applied taping according to groups. Before and after treatment, the OAB symptoms with the Overactive Bladder Assessment Form (OAB-V8) and Patients' Perception of Intensity of Urgency Scale (PPIUS), bladder function with a 3-day voiding diary, pelvic floor muscle strength with the Modified Oxford Scale, and quality of life with the King's Health Questionnaire (KHQ) were assessed. Results: OAB-V8, PPIUS, and KHQ scores decreased and the MOS improved in both groups (P <.05) after treatment. The intergroup comparisons revealed a further decrease in voids/day, voids/night, incontinence episodes/day, and personal limitation scores of the KHQ in the PFMT+KT group compared to the PFMT+ST group (P <.05). Conclusion: PFMT+KT was more effective in reducing the OAB symptoms compared to PFMT+ST. KT could be a complementary application for reducing symptoms in OAB. [ABSTRACT FROM AUTHOR]

Randomized controlled trials carried out in the field have not been deployed in the study of the comparative policy process. Recent field experiments in political science and public administration offer a model to follow with their insights into the classic topics of public policy, such as biases of decision-makers and responsiveness to citizen demands. This paper reviews the development of RCTs in policy evaluation and traces their impact more generally across the social sciences. Scholars in public policy have recently carried out several survey experiments, which suggests greater potential for making causal inferences from the field in future years. [ABSTRACT FROM AUTHOR]

To determine the effectiveness of manual therapy (MT) for functional outcomes in patients with distal radius fracture (DRF). An electronic search was performed in the Medline, Central, Embase, PEDro, Lilacs, CINAHL, SPORTDiscus, and Web of Science databases. The eligibility criteria for selecting studies included randomized clinical trials that included MT techniques with or without other therapeutic interventions in functional outcomes, such as wrist or upper limb function, pain, grip strength, and wrist range of motion in patients older than 18 years with DRF. Eight clinical trials met the eligibility criteria; for the quantitative synthesis, six studies were included. For supervised physiotherapy plus joint mobilization versus home exercise program at 6 weeks follow-up, the mean difference (MD) for wrist flexion was 7.1 degrees (p = 0.20), and extension was 11.99 degrees (p = 0.16). For exercise program plus mobilization with movement versus exercise program at 12 weeks follow-up, the PRWE was −10.2 points (p = 0.02), the DASH was −9.86 points (p = 0.0001), and grip strength was 3.9 percent (p = 0.25). For conventional treatment plus manual lymph drainage versus conventional treatment, for edema the MD at 3–7 days was −14.58 ml (p = 0.03), at 17–21 days −17.96 ml (p = 0.009), at 33–42 days −15.34 ml (p = 0.003), and at 63–68 days −13.97 ml (p = 0.002). There was very low to high evidence according to the GRADE rating. Adding mobilization with movement and manual lymphatic drainage showed statistically significant differences in wrist, upper limb function, and hand edema in patients with DRF. [ABSTRACT FROM AUTHOR]

Volunteering has been identified as a potential mechanism for improving the psychosocial health of older adults. Utilizing a randomized controlled trial approach, the present study assessed the extent to which commencing volunteering can improve psychosocial health outcomes for older people. Fully retired Australian adults aged 60+ years (N= 445) were assessed at baseline and allocated to either the intervention or control arms of the trial. Those in the intervention condition were asked to participate in at least 60 min of formal volunteering per week for 6 months. Per-protocol analyses were conducted comparing psychosocial outcomes for those who complied with the intervention condition (n= 73) to outcomes for those who complied with the control condition (n= 112). Those who complied with the intervention condition demonstrated significant improvements in life satisfaction, purpose in life, and personal growth scores over a 12-month period relative to those in the control condition who did no volunteering. Findings provide evidence of a causal relationship between commencing volunteering and improvements in psychosocial health among older adults and indicate that encouraging participation in this activity could constitute an effective healthy aging intervention. [ABSTRACT FROM AUTHOR]

New intensive trauma-focused treatment (TFT) programmes that incorporate physical activity have been developed for people with post-traumatic stress disorder (PTSD). However, the unique contribution of physical activity within these intensive TFT programmes has never been investigated in a controlled manner. This randomized controlled trial will investigate the effectiveness of physical activity added to an intensive TFT programme. In addition, the study aims to investigate the underlying mechanisms of the effects of physical activity on the change in PTSD symptoms. Individuals with PTSD (N = 120) will be randomly allocated to two conditions: a physical activity or a non-physical active control condition. All participants will receive the same intensive TFT lasting eight days within two consecutive weeks, in which daily prolonged exposure and EMDR therapy sessions, and psycho-education are combined. The amount of physical activity will differ per condition. While the physical activity condition induces daily physical activities with moderate intensity, in the non-physical active control condition no physical activity is prescribed; but instead, a controlled mixture of guided (creative) tasks is performed. The two primary outcome measures are change in PTSD symptoms from pre- to post-treatment and at six months follow-up, measured with the Clinician-Administered PTSD Scale (CAPS-5), and the PTSD Checklist for DSM-5 (PCL-5). Additionally, self-reported sleep problems, depressive symptoms, emotion regulation, dissociation symptoms and anxiety sensitivity will be measured as potential underlying mechanisms. This study will contribute to the research field of augmentation strategies for PTSD treatment by investigating the effectiveness of physical activity added to intensive TFT. This trial is registered in the Netherlands Trial Register (Trial NL9120). This study will be the first to determine the effectiveness of physical activity as add-on to an intensive TFT programme, and to investigate the underlying mechanisms of the effects of physical activity on the treatment-related change in PTSD symptoms. [ABSTRACT FROM AUTHOR]

This is the first study to provide experimental evidence of the impact of corequisite remediation for students underprepared in reading and writing. We examine the short-term impacts of three different approaches to corequisite remediation that were implemented at five large urban community colleges in Texas, and we explore whether corequisites have differential impacts on students with different characteristics. Results from three first-time-in-college cohorts indicate that corequisite remediation increased the probability of completing a first college-level English course within one year by 24 percentage points and within two years by 18 percentage points. The impacts were positive for all three of the corequisite models examined and for traditionally underrepresented groups, including Hispanic students, first-generation college students, and students whose first language is not English. We saw modest positive impacts on the accumulation of college credits but no effect on persistence in college. [ABSTRACT FROM AUTHOR]

There are conflicting results as to the effect of inhaled nitric oxide (iNO) therapy on the risk of acute kidney injury (AKI). The aim of this study was to perform a meta-analysis to assess the updated data. We systematically searched Web of Science, the Cochrane Library, Wanfang, and PubMed for relevant randomized control trials between database inception and 9/07/2020. Relative risks (RRs) with 95% confidence intervals (CIs) predicting the risk of AKI were extracted to obtain summary estimates using fixed-effects models. The Trim and Fill method was used to evaluate the sensitivity of the results and adjust for publication bias in meta-analysis. 15 randomized controlled studies from 14 articles involving 1853 patients were included in the study. Analyzing the eligible studies we found: (1) iNO therapy significantly increased the risk of AKI in acute respiratory distress syndrome patients (RR 1.55, 95% CI 1.15–2.10, p = 0.004; I2 for heterogeneity 0%; Phet = 0.649). (2) The use of iNO was associated with reduced AKI risk in patients undergoing cardiac surgery (RR 0.80, 95% CI 0.64–0.99, p = 0.037; I2 for heterogeneity 0%; Phet = 0.528). (3) For organ transplantation recipients, there was no effect of iNO administration on the risk of AKI (RR 0.50, 95% CI 0.16–1.56, p = 0.233; I2 for heterogeneity 0%; Phet = 0.842). The Trim and Fill analysis showed that the overall effect of this meta-analysis was stable. The effect of iNO on AKI risk might be disease-specific. Future RCTs with larger patient populations should aim to validate our findings. [ABSTRACT FROM AUTHOR]

We examined the effectiveness of the video-feedback Intervention to Promote Positive Parenting-Sensitive Discipline (VIPP-SD) in enhancing maternal sensitivity and decreasing maternal physical intrusive behaviors among Turkish mothers. Mothers (N = 68; Mage = 29.29, SD = 5.20) with their children (Mage = 20.04 months, SD = 6.62) participated in a randomized controlled trial with pre-, post-, and follow-up assessments (Nintervention = 40, Ncontrol = 28). Maternal sensitivity was assessed using the Ainsworth Sensitivity Scale. A coding schema was developed and used to assess maternal physical intrusiveness. The results indicated that mothers in intervention group benefited from the VIPP-SD in both increasing their global sensitivity (d = 0.51, p =.016) and decreasing the frequency of physical intrusive behaviors (d = 0.56, p =.007) compared to mothers in the control group. Overall, the VIPP-SD program appears to decrease the level of physical intrusiveness, in addition to promoting maternal sensitivity among Turkish mothers. [ABSTRACT FROM AUTHOR]

We evaluated the safety and immunogenicity of four doses of 20 or 60 µg, and the immunogenicity and compliance of the short-term vaccination regimen (0, 1, and 2 months) among patients receiving MMT. We conducted a randomized controlled trial among 303 patients receiving MMT who were randomized to receive 3 or 4 doses of 20 or 60 µg of recombinant hepatitis B vaccine. At month 7, the seroconversion rates in both IM20 × 4 and IM60 × 4 groups were numerically higher than the IM20 × 3 group (P > 0.05). The high-level responses and geometric mean concentration (GMC) of anti-HBs in both IM20 × 4 and IM60 × 4 groups were significantly higher than the IM20 × 3 group (P < 0.05). The completion rate of the short-term high-strength vaccination group was significantly higher than the standard vaccination group (P < 0.05), with similar immunogenicity (P > 0.05). Both the high-strength and standard-strength four-dose hepatitis B vaccine regimens could improve the immune response for patients receiving MMT. The high-strength short-term vaccination regimen could improve compliance and attain comparable immunogenicity with the standard vaccination regimen. The high-strength short-term vaccination regimen is recommended and the fourth dose is encouraged for this population considering the compliance and immunogenicity. ClinicalTrials.gov (NCT03962816) [ABSTRACT FROM AUTHOR]

To evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated urinary tract infection (UTI) or complicated UTI. In this randomized, active-controlled clinical trial, the patients with acute uncomplicated UTI were randomized to receive sitafloxacin 100-mg once-daily (qd) or levofloxacin 500-mg qd orally for 3–5 days. The patients with complicated UTI were randomized to receive sitafloxacin 100-mg twice daily or levofloxacin 500-mg qd orally for 10–14 days. The primary endpoint was the clinical efficacy at test-of-cure (TOC) visit. At TOC visit, the clinical cure rate was 89.2% (58/65) in sitafloxacin group and 97.1% (68/70) in levofloxacin group for the patients with acute uncomplicated UTI corresponding to the bacterial eradication rate of 97.1% (34/35) and 97.6% (41/42) (all p >.05), respectively. For the patients with complicated UTI, the clinical cure rate was 81.8% (27/33) in sitafloxacin group and 76.9% (20/26) in levofloxacin group corresponding to the bacterial eradication rate of 93.3% (14/15) and 63.6% (7/11) (all p >.05), respectively. Sitafloxacin and levofloxacin showed similar incidence of drug-related adverse events. Oral sitafloxacin is as effective and safe as levofloxacin in treating acute uncomplicated and complicated UTI. Oral sitafloxacin showed similar clinical cure rate and bacterial eradication rate as levofloxacin for treatment of complicated and uncomplicated urinary tract infections (UTIs) in a randomized, active-controlled, multicentre clinical trial. Oral sitafloxacin is safe and well-tolerated in treating acute uncomplicated and complicated UTIs in Chinese adults. Sitafloxacin is a promising alternative treatment option for UTIs in adults. [ABSTRACT FROM AUTHOR]

Background: Research suggests dyadic interventions can increase physical activity; such interventions are untested within postpartum parent couples. Methods: A three-armed pilot randomized trial addressed this gap and tested which type of dyadic intervention is most effective. Inactive postpartum mothers and a significant other were recruited in Australia (n = 143 assessed for eligibility) and randomised in a single-blinded fashion (i.e. participants were blinded) to 1 of 3 dyadic conditions involving a single face-to-face session with access to web-based group support: a minimal treatment control (n = 34), collaborative planning group (n = 38), or collaborative planning + need supportive communication group (n = 30). Participants were asked to wear their accelerometers for 8 days and completed self-report measures at baseline, end of intervention (week 4), and follow-up (week 12). We expected dyads in the collaborative planning + need supportive communication group would have the greatest increases in Physical Activity (PA), autonomous motivation, and partners' need supportive behaviours; and decreases in controlled motivation and controlling partner behaviours. Results: Results from 51 dyads using Bayesian actor-partner interdependence models provided some evidence for a small positive effect on total PA at follow-up for postpartum mothers in the collaborative planning group and for partners in the collaborative planning + need supportive communication group. Furthermore, partners in the collaborative planning + need supportive communication group were more likely to engage in some vigorous PA. At follow-up, postpartum mothers in the collaborative planning + need supportive communication group scored lower on personal autonomous reasons. Conclusions: The impact of prior specification mean intervention effects need to be interpreted with caution. Progression to a full trial is warranted. [ABSTRACT FROM AUTHOR]

Many adolescents in residential care have experienced traumatic events and suffer from posttraumatic stress. Prolonged activation of neurobiological stress systems as the autonomic nervous system (ANS) and the hypothalamic-pituitary-adrenal (HPA) axis can result in long-lasting maladaptive alternations. This study investigated the effectiveness of Muse, a game-based meditation intervention, on the sympathetic nervous system (SNS), parasympathetic nervous system (PNS), and cortisol basal activity and reactivity to acute stress among adolescents with posttraumatic symptoms in residential care. The intervention consisted of two gameplay sessions a week, for 6 consecutive weeks. Seventy-seven adolescents with clinical levels of posttraumatic symptoms (10–18 years old) received either Muse as an addition to treatment as usual (n = 40) or treatment as usual alone (n = 37). We expected reduced basal activity for the SNS and cortisol and increased basal activity for the PNS. As for the response to acute stress, we expected decreased PNS and increased HPA axis reactivity. The Muse group exhibited lower basal activity for the SNS and increased HPA reactivity to acute stress. There were no differences between conditions on SNS and HPA axis activity during rest and on SNS and PNS reactivity to acute stress. Game-based meditation therapy is a promising intervention for the treatment of adolescents with posttraumatic symptoms in residential care. Implications for clinical relevance and trauma-focused treatment purposes are discussed. [ABSTRACT FROM AUTHOR]

Neoliberalism, health and illness are all vast topics that range from global to local, personal to political. Critical realism offers valuable concepts, which help to extend and deepen analysis of these large, complex research areas. These include attending to unseen causal influences, absence, values, power, interests, structure and agency and morphogenesis. The four planes, which connect all interrelating forms of social being, provide a framework for managing large, wide-ranging and inter-disciplinary research data and for contextualizing small studies. Critical realism is contrasted with paradigms such as positivism, realist evaluation and actor network theory. This paper is based on a 20-hour generic course about critical realism for doctoral students, initiated by Roy Bhaskar. It uses the example of neoliberalism, health and illness to illustrate how useful critical realism can be as a research resource. The paper is also about the importance of understanding contemporary health in the context of neoliberalism. [ABSTRACT FROM AUTHOR]

A novel, audio-based brief mindful hypnosis (BMH) intervention for reducing stress-reactivity during the Trier Social Stress Test (TSST) was investigated. Fifty-five college-aged participants with elevated stress were randomized to BMH or a cognitive training (CT) active-control condition. Participants received a BMH or CT session and downloaded the audio-recorded intervention for daily home practice. Approximately 1 week later, participants received their second BMH or CT session and then completed the TSST. Results indicated BMH produced significant and medium effects in reducing stress reactivity and weekly stress and increasing mindfulness, with large increases in immediate relaxation compared to the CT active control. BMH demonstrated excellent adherence and was rated highly regarding satisfaction, ease of practice, perceived benefit, and likelihood of future use. This study provides the first empirical support that BMH is superior to an active-control intervention for reducing stress reactivity while significantly increasing mindfulness and relaxation. [ABSTRACT FROM AUTHOR]

School safety continues to be a concern in today's schools, and comprehensive approaches to school safety are one way to address this concern. However, few comprehensive approaches have been rigorously evaluated. To address this gap, we evaluated the implementation and effects associated with Safe Communities Safe Schools (SCSS) comprehensive school safety framework. Forty-six middle schools received SCSS within a staggered randomized implementation design. Implementation data, classroom observations, staff and student perceptions of school climate, student attendance/truancy, suspension rates, and academic test scores indicated that schools implemented some SCSS components as intended. Mixed impacts were found on school climate, student behavior, and academic outcomes. Findings suggest that implementation data highlights barriers to bringing interventions to scale and comprehensive interventions produce changes sequentially. Comprehensive frameworks hold promise for building staff capacity and the necessary infrastructure to reduce school violence – but require engagement and commitment of key staff, and sufficient time for change to occur. [ABSTRACT FROM AUTHOR]

The waxing-and-waning nature of hidradenitis suppurativa (HS), complex treatment plans, along with variable responsiveness to therapy, can create management challenges for patients. In this pilot cross-over randomized controlled trial, we aim to evaluate the effectiveness a HS-written action plan (HSWAP) on patient disease understanding and confidence in recognizing flares and adjusting management. Participants were randomized into a pre-crossover control group that received a verbal consultation (VC)-only, and an intervention group which received the VC + HSWAP. The pre-crossover control group then crossed over (post-crossover control) to also receive the VC + HSWAP (ClinicalTrials.gov Identifier: NCT04600375). Patient comprehension of their disease and management steps was high after both a thorough VC and HSWAPs. However, the majority of patients prefer receiving both a VC and a HSWAP. After the addition of the HSWAP, pre-crossover control group patients' understanding and confidence of their disease and management plan increased across all surveyed questions. [ABSTRACT FROM AUTHOR]

This study investigated the phagocytic cell response in malnourished children after oral feeding of a fermented product containing clinically proven probiotic strains of Lactobacillus acidophilus, LBKV-3. The bacterial strain is used as a probiotic for humans to test its effect on immune cell activity in undernourished children below 8 years of age. To study the immune cell activity, implantation abilities of the culture in the GI tract of malnourished children, forty-five children of 6–7 and 7–8 years were randomly selected and distributed in three groups, each comprising 15 children in each of the age group. The test group of the children was receiving 100 g product volunteers/day of freshly prepared probiotic acidophilus milk containing 107 cfu/g of culture. The control group was receiving 100 g freshly prepared "dahi" containing 107 cfu/g of the LAB while the blank group of the volunteers was receiving thermal processed (85° C/30 min) buffalo milk containing 5% fat and 10% SNF at the rate of 100 ml/day/volunteer. Feeding trial was continued for 12 weeks. Blood samples were collected at W2, W4, W8, and W12. The blood serum samples were analyzed for monocytes, neutrophils, basophils, and lymphocytes by BC-3000 + Auto Hematology Analyzer. In conclusion, consumption of PAM increased the proportion of immune cells, including monocytes, neutrophils, basophils, and lymphocytes, as well as their phagocytic activity in all age groups but proportion was significant in the test group of 7–8 years. The effects were higher during W12 compared to W2, W4, and W8, which suggest regulation of the immune system. [ABSTRACT FROM AUTHOR]

In CAPTAIN, a double-blind, parallel-group, Phase IIIA study, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) improved lung function, symptoms and asthma control versus FF/VI in patients with inadequately controlled asthma. Here, we report efficacy and safety from a Japanese cohort in CAPTAIN. Adults with inadequately controlled asthma despite inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) were randomized (1:1:1:1:1:1) to once-daily FF/VI (100/25 mcg or 200/25 mcg) or FF/UMEC/VI (100/31.25/25 mcg, 100/62.5/25 mcg, 200/31.25/25 mcg, or 200/62.5/25 mcg) for ≥24 weeks. Endpoints included change from baseline in clinic trough FEV1 (primary), annualized rate of moderate/severe asthma exacerbations (key secondary), clinic FEV1 3 h post-dose, and Asthma Control Questionnaire (ACQ)-7, St George's Respiratory Questionnaire (SGRQ) (all Week 24), Evaluating Respiratory Symptoms (E-RS): Asthma total scores (Weeks 21–24) (all secondary). Adverse events and adverse events of special interest were monitored. Clinical trials.gov registry no: NCT02924688. Overall, 229 of 2436 patients in the intention-to-treat (ITT) population were from Japan. In this cohort, change from baseline in trough FEV1 for FF/UMEC/VI 100/62.5/25 mcg versus FF/VI 100/25 mcg was 105 mL (95% confidence interval −5, 216) and 69 mL (–42, 179) for 200/62.5/25 mcg versus 200/25 mcg. These observations were supported by clinic FEV1 at 3 h post-dose. Moderate/severe exacerbation incidence was low and similar across pooled treatment groups (FF/VI, FF/UMEC 31.25 mcg/VI, FF/UMEC 62.5 mcg/VI). All pooled groups demonstrated clinically important improvements from baseline in ACQ-7, SGRQ and E-RS: Asthma total scores. Safety profiles were consistent with the overall ITT population, with no new safety concerns. FF/UMEC/VI is an effective option with a favorable risk-benefit profile in Japanese patients with uncontrolled moderate or severe asthma on ICS/LABA. [ABSTRACT FROM AUTHOR]

Subjective well-being (SWB) may buffer against psychosocial stressors such as the birth of a child. To assess the effectiveness of an unguided internet intervention ('Mamma Mia') on SWB among perinatal women, we investigated (1) whether the intervention group reported higher levels of SWB, (2) whether the effect of Mamma Mia changed over time (i.e. whether the intervention was more effective at some time points), (3) and potential moderators. In total, 1342 pregnant women were randomized to the Mamma Mia or control group. Data were collected at gestational weeks 21–25 and 37, and 1.5, 3, and 6 months after birth. Cognitive well-being was measured using the Satisfaction with Life Scale. Affective well-being was measured using the Positive and Negative Affect Schedule. There were no significant differences in reported life satisfaction and positive affect between the groups. However, participants in the Mamma Mia group showed less negative affect during follow-up, suggesting that Mamma Mia can enhance the affective component of perinatal women's sense of SWB. [ABSTRACT FROM AUTHOR]

The Say-All-Fast-Minute-Every-Day-Shuffled (SAFMEDS) strategy promotes fast and accurate recall. The existing literature suggests that the strategy can help learners improve academic outcomes. Through a cluster randomized controlled trial, we assessed the impact of implementation support on children's mathematics outcomes during a teacher-led SAFMEDS intervention. Following training and prior to baseline assessments, we randomly allocated schools to receive either no (n = 31) or ongoing (n = 33) support from a researcher. Support consisted of three in-situ visits and email contact. Assessors remained blind to the condition of the schools throughout. We analyzed the outcomes of children (nSupport = 294, nNoSupport = 281) using a multi-level mixed-effects model; accounting for the children nested within schools. The results suggest that implementation support has a small effect on children's fluency of arithmetic facts (Mathematics Fluency and Calculation Tests (MFaCTs): Grades 1–2, d = 0.23, 95% CI: 0.06–0.40; MFaCTs: Grades 3–5, d = 0.25, 95% CI: 0.08–0.42). These results are larger than the average effect sizes reported within professional development literature that apply coaching elements to mathematics programs. [ABSTRACT FROM AUTHOR]

The authors of this article describe the design and implementation of a multi-site randomized controlled trial of team-based learning (TBL) application exercises (AE) in introductory economics courses that use TBL. For each of the four study modules that are common across sites, a site is assigned to either the treatment or control version of the module. This design enables the use of a fixed effects model to estimate the effect of treatment on student learning and control for student characteristics. The methodology demonstrates how to extract the benefits of multi-site randomized controlled designs using a minimum of resources. The authors also discuss the challenges and the lessons learned in this study. [ABSTRACT FROM AUTHOR]

In this pilot feasibility randomized controlled trial, participants with moderate to severe COPD were randomized to a 12-week tai chi or MBB intervention. Participants were assessed at baseline, 12 weeks, and 24 weeks. Feasibility, as assessed by intervention adherence, was the primary outcome. We also estimated preliminary between-group differences in COPD symptoms and health-related quality of life, cognitive-emotional function, and functional status across three timepoints: baseline, 12, and 24 weeks. A total of 92 participants were randomized 2:1 to tai chi (n = 61) or MBB (n = 31). The overall group adherence in the first 12 weeks was 62% in tai chi and 75% in MBB. From baseline to 12 weeks, tai chi demonstrated greater improvements in depressive symptoms (Cohen's d effect size (ES) = −.53; adj mean diff = −2.31 [-5.7, 1.07]), 6-minute walk test distance (ES =.47; adj mean diff = 62.04 [2.85, 121.22]), social support (ES =.36; adj mean diff =.19 [-0.11, 0.49]) and chair stand (ES =.44; adj mean diff =.91 [-0.05, 1.86]). Only improvements in social support were maintained at 24-week follow-up. Tai chi and MBB are feasible for individuals with COPD. Preliminary effects suggest that while our mindful breathing intervention may not be sufficient to impact outcomes, tai chi may result in short-term benefits in mood, social support and functional capacity. More work is needed to better understand mindful breathing for COPD and to examine methods for maintaining improvements from tai chi over time. Supplemental data for this article is available online at https://doi.org/10.1080/15412555.2021.1928037. [ABSTRACT FROM AUTHOR]

Mycosis fungoides is the most common type of primary cutaneous T cell lymphomas. Doxycycline promoted apoptosis in different human malignant cell lines and in vivo models. To test for the therapeutic efficacy of doxycycline in comparison to PUVA in early stages of classic MF and its effect on T cell apoptosis. Thirty-six patients were randomized into either: doxycycline 200 mg daily (n = 18) or PUVA (3 weekly sessions) (n = 18) for 12 weeks. The primary outcome (therapeutic efficacy) was defined in terms of objective response rate (ORR) which was measured according to changes in the modified severity weighted assessment tool (mSWAT). Doxycycline achieved significantly less ORR (partial response) in comparison to PUVA (11.1%, 50%, respectively, p =.016). The percent reduction in mSWAT, CAILS, histopathology score and CD3 expression was significantly less in the doxycycline group (p =.001, p =.001, p ˂.001, and p =.004, respectively). Within the doxycycline group, changes in mSWAT and CAILS showed no correlation with changes in the CD3 or Bcl-2 expression. Gastric upset was significantly more encountered in the doxycycline group (p =.001). Doxycycline is not suitable as a sole agent in the treatment of early stages of classic MF, acting mainly by anti-inflammatory rather apoptotic function. NCT03454945 (). [ABSTRACT FROM AUTHOR]

Background: The immunogenicity against hepatitis B vaccine is unsatisfactory in the chronic kidney disease (CKD) patients, and studies evaluating augmented vaccine regimens to enhance immunogenicity have been inconclusive. Objectives: To evaluate the immunogenicity and safety of four-standard-dose and four-triple-dose regimens hepatitis B vaccine among CKD patients in China. Research design and methods: We conducted a multicenter, randomized, parallel-controlled trial including 273 patients with CKD who were randomly allocated to receive 3 or 4 doses of 20 or 60 µg of recombinant hepatitis B vaccine. Main outcome measures: Seroconversion rates, high-level response rates, and geometric mean concentrations (GMCs) of anti-HBs at months 3 and 7. Results: The seroconversion rates and high-level responses in the IM20 × 4 group and the IM60 × 4 group were higher than those in the IM20 × 3 group at months 3 and 7 (P < 0.05). The IM60 × 4 group had better immune responses than the IM20 × 4 group at month 3 (P < 0.05); however, no significant difference was noted at month 7 (P > 0.05). Conclusions: Both the four-standard-dose and four-triple-dose regimens improved immune response compared to the three-standard-dose regimen of hepatitis B vaccination in CKD patients, and the additional effect of higher dose was minimal. Trial registration: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT03962881). [ABSTRACT FROM AUTHOR]

Few studies have addressed external validity of randomized controlled trials in infectious diseases. We aimed to assess the external validity of an investigator-initiated trial on treatment for uncomplicated urinary tract infection. In the original study, women (n = 513) with urinary tract infection were randomized to nitrofurantoin or fosfomycin treatment in three countries between 2013 and 2017. In the present study we compared women who were screened for enrolment but excluded to women who participated in the trial, both groups in Israel. The primary outcome was the rate of emergency department index visits resulting in hospitalization within 28 days. We compared 127 included to 110 excluded patients. The most common reasons for exclusion were logistic difficulties in recruitment and antibiotic use in the preceding month. Included patients tended to be older [39 (IQR 29–59) vs. 35.5 (IQR 24–56.25 years)], more likely to have history of recurrent infection and had more urinary symptoms. Among excluded patients, 13.6% (15/110) had initial visits resulting in hospitalization compared to 3.1% (4/127) of included participants (p =.003). The rate of emergency department visits within 28 days was similar in both groups. Clinical and microbiological failures were significantly more common in included patients [26% (33/127) vs. 1.8% (2/110), p <.001; 7.9% (10/127) vs. 0% (0/110), p =.003; respectively]. While differences were observed between included and excluded patients, the excluded group did not represent a more 'complicated' population. The present study shows the importance of collecting data on patients excluded from randomized controlled trials. [ABSTRACT FROM AUTHOR]