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Polymer polyvinylpyrrolidone (PVP) can be described as the main coating. After heating and curing, it is able to build a strong adhesion to the latex catheter for creating a durable and effective hydrophilic coating. In this study, we aim to explore the advantages and disadvantages of the new super lubricath latex catheter PVP coating compared with the common latex catheter. 148 patients who participated in the study were completely randomly divided into two groups, the observation group and the control group. When the urinary catheter was incubated, indwelling in subjects' body, and removed from the subjects, the researchers accordingly recorded the subjects' comfort feedback, device safety evaluation and the patient's vital signs, relevant blood and urine examination index, electrocardiogram (ECG) changes and recorded various adverse events. PVP super lubricath coating latex catheter offered better comfort, less damage to the urethra, and no significant disadvantage in safety compared to regular latex catheters, improving quality of care and patient satisfaction compared to regular latex urinary catheters. [ABSTRACT FROM AUTHOR]

A vast majority of elementary students struggle with the core, pre-algebraic concept of mathematical equivalence. The Improving Children's Understanding of Equivalence (ICUE) intervention integrates four research-based strategies to improve outcomes for second grade students: (1) introducing the equal sign before arithmetic, (2) nontraditional arithmetic practice, (3) concreteness fading exercises, and (4) comparison and explanation. In a large-scale randomized control trial in California public schools, 132 second grade teachers were randomly assigned to either use the ICUE intervention or an active control consisting of nontraditional arithmetic practice alone. Using data from 121 teachers in the analytic sample, the study found that students in the intervention group outperformed students in the active control on proximal and transfer measures of equivalence with no observable tradeoffs in computational fluency. The findings suggest that the ICUE intervention helps students construct a robust understanding of mathematical equivalence, a critical precursor to success in algebra. [ABSTRACT FROM AUTHOR]

Background: Awareness regarding coping with sick days among patients with diabetes is limited. Thus, we evaluated the effectiveness of sick-day education by community pharmacists among patients with type 2 diabetes (T2D) using sick-day educational materials (sick-day cards). Methods: A cluster randomized controlled trial was conducted. Pharmacists in the intervention group educated patients with T2D on coping with sick days (adjusting medication dosage and seeking medical advice) using sick-day cards compared with the usual counseling. Differences in questionnaire scores ("Anxiety", "Intention", "Attitude", and "Knowledge" about sick days) before and after the intervention were compared between the groups. Results: Overall, 318 patients with T2D (intervention, 119; control, 199) participated in this study, and 270 (intervention, 92; control, 178) patients were examined. There were no significant differences in "Anxiety", "Intention", or "Attitude" scores between the two groups, but "Knowledge" scores improved in the intervention group. For all intervention groups (92/92), a physician reviewed and approved medication and adjustment doses for sick days on the cards. Conclusions: According to patients' responses, sick-day education using teaching materials improved patient knowledge. This may help patients and their caregivers cope with sick days appropriately through medication dose adjustment and fluid intake. Research registration number: UMIN000043161 (February 1, 2021), https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgifunction=brows&action=brows&recptno=R000048124&type=summary&language=J [ABSTRACT FROM AUTHOR]

To determine the effect of a 6-month traditional Chinese mind-body Baduanjin exercise intervention on cognitive ability in older people with Mild cognitive impairment (MCI). A total of 135 community-dwelling seniors with MCI were randomized into either the Baduanjin group (BDJ), the brisk walking group (BWK) or the usual physical activity control group (UPA). Cognitive ability was assessed at baseline, 2, 4 and 6 months post-intervention, and 3 months after the intervention ended. After 6 months of intervention, the MoCA score of the BDJ group was significantly higher than that of the UPA group (P < 0.05), The Go/No-go correct numbers of the BDJ group and BWK group were significantly higher than those of the UPA group (P < 0.05). There was no statistical difference in other outcomes, or there were only a tiny effect size. Three months after the intervention, there was no significant difference between the primary and secondary outcomes(P > 0.05). The 6-month period of Baduanjin training has positive benefits on global cognitive function and attention function in community-dwelling elderly individuals with MCI. The effect seems to have been transient and needs to be confirmed by additional studies. [ABSTRACT FROM AUTHOR]

Online interventions that elicit kindness may enhance well-being. We tested the efficacy of three kindness interventions among breast cancer survivors. Participants (N = 137, Mage = 62.65 years) were randomized to perform acts of kindness for others, acts of kindness for self, self-kindness meditation, or a daily-activities-writing control and completed three activities each week for 4 weeks. Primary (well-being, depressive symptoms) and secondary outcomes (social support, self-kindness) were assessed pre- and post-intervention. No differences emerged in the primary outcomes. However, relative to controls, participants in the acts of kindness to others condition reported greater increases in social support, and participants in the self-kindness meditation condition reported greater decreases in self-kindness. Among breast cancer survivors, performing prosocial acts may enhance feelings of social support. The two self-kindness conditions yielded either null or detrimental effects, suggesting that further research is needed on best practices for conducting self-focused kindness interventions. [ABSTRACT FROM AUTHOR]

To determine the efficacy of the "Training for Occupational health physicians To Involve Significant others" (TOTIS) e-learning module for improving occupational health physicians' (OHPs) knowledge, attitudes, and self-efficacy regarding involving significant others in the return-to-work process. A randomized controlled trial with 87 OHPs, involving an intervention group and a wait-listed control group. Between-group differences in knowledge, attitude, and self-efficacy outcomes, and retention of effects were assessed using ANOVA and paired t-tests. Reactions to the e-learning module were analyzed with descriptive statistics and thematic analysis. We found moderate to large effects on OHPs' knowledge (p < 0.001, ηp2 = 0.202), attitudes (p = 0.003, ηp2 = 0.098), and self-efficacy (p < 0.001, ηp2 = 0.237), with retention of all changes at 10-week follow-up. OHPs graded the e-learning module with a mean score of 7.9 out of 10 (SD = 1.11) and indicated that the module increased their awareness of the role of significant others and encouraged them to address this more often. The TOTIS e-learning module and accompanying materials are valuable resources for OHPs to learn how significant others influence work outcomes of workers with chronic diseases and to manage their involvement in the re-integration process. This study is registered in the Netherlands Trial Register under trial number NL8744; . The TOTIS e-learning module is the first evidence-based training to improve the knowledge, attitudes, and self-efficacy of occupational health physicians with regard to involving significant others in the re-integration process of workers with chronic diseases. The e-learning module and accompanying tools can increase the awareness of occupational health physicians about the role of significant others and encourage them to address the role of significant others in the re-integration process of sick-listed workers. It could be beneficial to expand on the e-learning module with a face-to-face training program involving group interaction, peer discussion, and skills development. [ABSTRACT FROM AUTHOR]

Satisfaction from police performance in cases that are screened out from police investigation is low, particularly for victims who report online. In a randomized controlled trial, we report the impact of reassurance telephone callbacks on satisfaction scores for victims of vehicle crime in London, United Kingdom. Evidence suggests that reassurance callbacks cause victims to express more favorable attitudes toward the police, with more pronounced satisfaction scores among minority victims, particularly those who report their crime online. We argue that callbacks to victims are advantageous in an era of a police legitimacy crisis with diminished resources for law enforcement. [ABSTRACT FROM AUTHOR]

The results of treatment effect of vitamin or antioxidant intake on diabetic peripheral neuropathy (DPN) was inconsistent. Therefore, we performed a meta-analysis of randomized controlled trials (RCTs) to examine whether these supplements are effective in DPN treatment. We searched seven databases from inception to October 2021. All RCTs of DPN treatments with vitamin and antioxidant supplements were included. We performed sensitivity and subgroup analysis, and also tested for publication bias by the funnel plot and Egger's test. A total of 14 studies with 1384 patients were included in this systematic review. Three high-quality trials showed that vitamin and antioxidant supplements significantly increased sensory nerve conduction velocity (SNCV) of the sural nerve (MD = 2.66, 95%CI (0.60, 4.72), P < 0.05, I2 = 0%). Seven studies (758 participants) suggested that these supplements might have improvement on motor nerve conduction velocity (MNCV) of the peroneal nerve in DPN patients with the random-effect model (MD = 0.60, 95%CI (0.28, 0.92), P < 0.05, I2 = 65%). In four studies, these supplements could have improved on MNCV of the median nerve with the fixed-effect model (MD = 4.22, 95%CI (2.86, 5.57), P < 0.05, I2 = 0%). However, ten studies (841 participants) have suggested that vitamin and antioxidant supplements have not decreased glycosylated haemoglobin (HbA1c). Vitamin and antioxidant supplements may improve the conduction velocity of nerves, including median, sural and peroneal nerves of patients with DPN. But these supplements have not decreased HbA1c in DPN patients. Several trials with a large sample size are needed to provide evidence support for clinical practice in the future. [ABSTRACT FROM AUTHOR]

A randomized controlled trial was conducted to study the effectiveness of two readers' theater (RT) programs in promoting reading skills and motivation of dysfluent readers in Grades 3–4. One program (RT Goal) included a goal of preparing a performance for an audience (n = 50), while another program (RT Practice) did not include such a goal (n = 49). A group of dysfluent readers receiving traditional oral reading intervention (Control group; n = 59) and a group of classroom peers (Mainstream group; n = 159) served as controls. The results indicate that both RT groups and the Control group developed at a higher rate in oral reading speed during the intervention period than the Mainstream group. The RT Goal program was associated with higher engagement ratings and a temporary reduction in reading errors and oral reading anxiety. RT had no effects on silent reading skills or reading self-efficacy. [ABSTRACT FROM AUTHOR]

Abstract Although designed to prepare students for future coursework or to fulfill basic degree requirements, introductory math courses often serve as barriers to student success. In two double-blind randomized field experiments, we tested the efficacy of a utility-value intervention on improving community college students’ perceived math relevance and achievement in introductory math courses. Building upon prior research, we examined whether the intervention particularly benefited first-generation and racially marginalized students. Study 1 (N = 696) was conducted before the COVID-19 pandemic and within in-person classrooms, whereas Study 2 (N = 1,318) was conducted during the pandemic and within virtual learning environments. Across Studies 1 and 2, students in the utility-value condition benefited more in terms of their perceived relevance compared to their peers in the control condition. Additionally, in both studies, math relevance mediated the effects of the intervention on math grades. In Study 2, with a larger sample, the positive effect of the intervention on math relevance was more pronounced for first-generation students. Our findings imply that community colleges could significantly improve students’ academic experiences by investing in motivation-enhancing activities such as utility-value interventions in introductory math courses. This strategy could especially help first-generation students’ academic achievement and retention rates. [ABSTRACT FROM AUTHOR]

Diagnosis and treatment of childhood brain tumor have detrimental effects on physical, neurocognitive, psychological, and social functioning that lasts into adulthood and effects quality of life (QOL). To address diminished QOL, an Internet-based behavioral activation (BA) intervention was developed. Behavioral activation aims to increase activities and behaviors likely to improve thoughts, mood, and QOL. Participants included 127 young adult survivors of childhood brain tumor (SCBT) randomized into the experimental group (n= 64) or the waitlist control group (n= 63). The dependent variables included: life satisfaction, stress, and activation and were assessed with a two-way mixed analysis of variance (ANOVA). Results revealed a significant interaction between the intervention and time on life satisfaction, F(1, 125)=4.793, p = 0.03. There were no significant main effects over time for perceived stress and activation. Findings offer initial evidence that BA can be delivered over the internet and that Internet-delivered BA can have a positive effect on the QOL of young adult SCBT. Internet-based BA interventions can serve as a resource for young adult SCBT who desire to boost their mood and QOL. Behavioral activation (BA) is aimed at increasing positively reinforcing overt behaviors that are likely to promote improved thoughts, mood, and quality of life (QOL). Results indicated study participants in the experimental group demonstrated a significant gain in life satisfaction compared to the control group after receiving the Internet-based BA intervention; and provides support that the intervention was associated with positive changes across time. Findings offer initial evidence that BA can be delivered over the internet and that Internet-delivered BA can have a positive effect on the QOL of young adult survivors of childhood brain tumor (SCBT). Internet-based BA interventions can serve as a resource for young adult SCBT who desire to boost their mood and QOL. [ABSTRACT FROM AUTHOR]

Asthma is known as one of the most common chronic inflammatory diseases characterized by recurrent obstruction and inflammation of the airways. Probiotics are defined as a group of beneficial living microorganisms that are beneficial in many disorders, including allergies. The aim of this study was to investigate the probiotic supplement effects on improvement of clinical asthma symptom and changes in the pattern of Th17-related inflammatory cytokines in asthmatic patients. This was a randomized controlled clinical trial with parallel, double-blind groups. Forty patients with asthma were enrolled and received 1 capsule/day of a probiotic supplement for 8 weeks. Respiratory function tests; and the level of IL-6, IL-17, IL-21 and TGF-β were evaluated at the baseline and end of intervention. The results showed that the level of IL-6 and IL-17 in patients after receiving probiotics was reduced and expression of TGF-β was increased as compared to the baseline. Also, the expression of IL-17 and IL-21 in the probiotic group was significantly lower than the placebo group at the end of the intervention. In addition, an improvement in pulmonary function tests and clinical symptoms was observed after receiving probiotics. Eight-weeks treatment with a probiotic supplementation suggests that it may effect on Th17 cells-associated IL-6, IL-17 and TGF-β; and Forced Expiratory Volume in 1 s and Forced Vital Capacity. Taken together, these results suggest that probiotics may have the ability to affect neutrophilic asthma and they can possibly be used besides common treatments for patients with neutrophilic asthma. [ABSTRACT FROM AUTHOR]

Children with ADHD show impairments in set shifting task performance. However, the limited available evidence suggests that directly training shifting may not improve shifting performance in this population. We hypothesized that this incongruence may be because impairments exhibited by children with ADHD during shifting tasks are due to deficits in other executive functions, as shifting tasks also engage children's working memory and/or inhibitory control abilities. This randomized controlled trial examined the extent to which neurocognitive training of working memory vs. inhibitory control can produce downstream (far-transfer) improvements in set shifting task performance. Children with ADHD ages 8–12 (M = 10.41, SD = 1.46; 12 girls; 74% White/Non-Hispanic) were randomized to either central executive training (CET; n = 25) or inhibitory control training (ICT; n = 29), two next-generation digital therapeutics previously shown to improve their intended neurocognitive targets. Two criterion set shifting tests were administered at pre- and post-treatment. Results indicated that ICT was superior to CET for improving shifting accuracy (treatmentxtime: p =.03, BF10 = 3.01, η2 =.09, d = 0.63). ICT was also superior to CET for improving shifting speed, albeit on only one of the two outcome tasks (p =.02, BF10 = 4.53, η2 =.08, d = 0.59). CET did not produce improvements in shifting speed or accuracy on either task (p >.52, BF01 > 2.62), but showed evidence for more general (non-shifting-specific) improvement in response times on one of the outcome tasks (shift trials, d = 0.70; non-shift trials, d = 0.68). Taken together, these findings confirm that inhibitory control is important for successful performance on shifting tests, and suggest that training inhibitory control may reflect a method for improving set shifting difficulties in children with ADHD. [ABSTRACT FROM AUTHOR]

Comparative studies of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open CTR (mOCTR) are limited, prompting development of this randomized trial to compare efficacy and safety of these techniques. Patients were randomized (2:1) to CTR-US or mOCTR, treated by experienced hand surgeons (median previous cases: 12 CTR-US; 1000 mOCTR), and followed for 3 months. Among 149 randomized patients, 122 received CTR-US (n = 94) or mOCTR (n = 28). Mean incision length was 6 ± 2 mm in the wrist (CTR-US) vs. 22 ± 7 mm in the palm (mOCTR) (p < 0.001). Median time to return to daily activities (2 vs. 2 days; p = 0.81) and work (3 vs. 4 days; p = 0.61) were similar. Both groups reported statistically significant and clinically important improvements in Boston Carpal Tunnel Questionnaire Symptom Severity and Functional Status Scales, Numeric Pain Scale, and EuroQoL-5 Dimension 5-Level, with no statistical differences between groups. Freedom from wound sensitivity and pain favored CTR-US (61.1% vs. 17.9%; p < 0.001). Adverse event rates were low in each group (2.1% vs. 3.6%; p = 0.55). The efficacy and safety of CTR-US were comparable to mOCTR despite less previous surgical experience with CTR-US. The choice of CTR technique should be determined by shared decision-making between patient and physician. identifier is NCT05405218. [ABSTRACT FROM AUTHOR]

Randomized Controlled Trials (RCTs) are currently considered 'gold standard' for evaluating psychosocial interventions, including psychodynamic psychotherapies (PDTs). The aim of this review is to summarize all available RCTs involving PDTs. A thorough search yielded 298 studies published between 1967 and 2022. The number of studies has increased over time with 123 (41.2%) published in the last 10 years. Most studies have been conducted in western countries, evaluating PDTs of brief duration (<40 sessions) for adults with mood (k = 67, 22.5%), psychosomatic (k = 38, 12.8%), anxiety (k = 35, 11.7%), or personality disorders (k = 29, 9.7%). The studies have utilized comparative (k = 233, 78.2%), additive (k = 33, 11.1%), parametric (k = 30, 10.1%) and dismantling designs (k = 2, 0.7%) and includes a total of 374 comparisons. Categorization of outcomes suggests that PDTs typically outperforms inactive controls, while comparisons with active treatments, inclugding Cognitive-Behavior Therapy (CBT), typically indicate no statistical difference. While the evidence-base for PDTs is growing, there are still major limitations and many research questions yet to be addressed. There is a pressing need for disseminating the existing research for PDTs to policy makers and the general public, as well as integrating findings in psychodynamic training curriculums. [ABSTRACT FROM AUTHOR]

A major focus of HF palliative care is to reduce symptom burden, yet managing HF symptoms is complex and requires adequate problem-solving skills. Telehealth interventions that provide support and problem-solving training may enhance symptom management and reduce symptom distress. The purpose of this study was to examine the preliminary effectiveness of the Coping in Heart Failure (COPE-HF) Partnership telehealth intervention (ClinicalTrials.gov Identifier: NCT05337293) on HF symptom frequency, severity, and symptom-related degree of interference with physical activity and enjoyment of life. This was a three-group randomized controlled pilot study. The intervention group received one home visit and weekly (first month), then biweekly (months 2, 3) telephone calls. The attention group received a sham intervention on a similar schedule. The control group received usual care. The Heart Failure Symptom Survey was administered at baseline, 5, 9, and 13 weeks. Linear mixed modeling with restricted maximum likelihood estimation examined intervention effects on study outcomes. Of 107 enrolled participants, 66 completed the study. Participants were 61 years old; 56% non-Caucasian; and 54.2% male. Significant improvement in total HF symptoms and all sub-scales from baseline to 13 weeks were noted in the intervention group, with the largest improvement seen in HF symptom severity (md = −2.59, <0.001, 95% CI [−3.65, −1.53]). Providing support and tailored problem-solving training as a component of palliative care may empower patients to develop strategies to manage bothersome symptoms, thereby decreasing symptom severity. However, more research is needed to examine this intervention in a larger sample. Trial registration: ClinicalTrials.gov identifier: NCT05337293. [ABSTRACT FROM AUTHOR]

Objective: Randomized double-blind placebo-controlled trial was conducted with sixty pregnant women to evaluate the effect of antenatal omega-3 supplementation on maternal depressive symptoms from pregnancy to 6 months postpartum. Methods: Participants with gestational age between 22 and 24 weeks were randomized in placebo (olive oil; n = 30) or omega-3 (fish oil; n = 30) groups and supplemented until childbirth. Fish oil capsules provided 1440 mg/day of docosahexaenoic acid. Depressive symptoms were evaluated during the gestational period: (G1) 22–24 weeks; (G2) 26–28 weeks; (G3) 30–32 weeks; (G4) 34–36 weeks; and postpartum: (P1) second week; (P2) first month; (P3) fourth month; and (P4) sixth month, using the Edinburgh Postnatal Depression Scale (EPDS). Intention-to-treat and per-protocol analyses were performed using Generalized Estimating Equations (GEE). Results: Comparison between groups showed no differences in the EPDS score at any time during pregnancy or postpartum, in both intention-to-treat and per-protocol analysis (p > 0.05). Both groups presented a reduction in the EPDS score over time. According to intention-to-treat analysis, when comparing to the baseline, the placebo group showed a reduction in the EPDS score at P1 and P4, while the omega-3 group showed a reduction at all times from G4 to P4. In per-protocol analysis, the placebo group showed a reduction in the EPDS score at P3, while the omega-3 group showed a reduction at all times from G2 to P4. Conclusions: The supplementation with omega-3 did not promote significant differences between groups. However, an earlier reduction in the EPDS score was observed in the omega-3 group, which may indicate a benefit of antenatal omega-3 supplementation. [ABSTRACT FROM AUTHOR]

This study was conducted to assess the clinical efficacy of probiotics in the treatment of patients with COVID19. PubMed, Embase, Cochrane Library, and ClinicalTrials.gov were searched for studies from their inception to 8 February 2022. Randomized controlled trials (RCTs) that compared the clinical efficacy of probiotics with usual care or standard care for patients with COVID19 were included. The primary outcome was all-cause mortality. Random-effects model using MantelHaenszel and inverse variance methods were performed to analyze the data Eight RCTs with 900 patients were included. The study group receiving probiotics had a non-significantly lower rate of mortality than the control group had, but this difference was not significant (risk ratio [RR], 0.51; 95% CI, 0.22 to 1.16). However, the study group had significantly lower rates of dyspnea (RR, 0.11; 95% CI, 0.02 to 0.60), fever (RR, 0.37; 95% CI, 0.16 to 0.85) and headache (RR, 0.19; 95% CI, 0.05 to 0.65). Higher complete remission of COVID-19-associated symptoms was observed in the study group than the control group (RR, 1.89; 95% CI, 1.40–2.55). Although probiotics use did not improve clinical outcomes or reduce inflammatory markers, it may relieve COVID-19-associated symptoms. [ABSTRACT FROM AUTHOR]

To examine the effects of ride-on car (ROC) training using different postures on mobility and social function in children with motor delays in comparison with conventional therapy. Thirty-eight children (22 males, 16 females) with motor delays were recruited and randomly assigned to three groups: ROC training while sitting (ROC-Sit, n = 15; mean age, 20.25 months; standard deviation [SD], 5.29), ROC training while standing (ROC-Stand, n = 12; mean age, 24.80 months; SD, 8.42), and conventional therapy (control, n = 11; mean age: 20.25 months, SD: 5.37). All groups underwent 2-h training sessions twice weekly over a 12-week intervention phase. The Pediatric Evaluation of Disability Inventory and Goal Attainment Scaling were performed before and after the intervention and at follow-up sessions after 12 weeks. Mobility and goal achievement improved significantly in all groups after the intervention (p < 0.001; p < 0.0001). However, social function improved significantly only in the ROC-Stand group (p = 0.001), which had the highest number of participants showing clinically meaningful changes in mobility and social function. Increased practice and caregivers' involvement can improve children's mobility and goal achievement. Adopting a standing posture in an ROC can enhance social function. Providing active exploratory experience through ride-on cars or practicing specific skills can improve children's mobility function. Ride-on car training in a standing posture allows children to access their distal environment visually, resulting in improved social function. Setting goals with caregivers maximizes the effects of treatment on goal achievement. [ABSTRACT FROM AUTHOR]

Cognitive stimulation is a recommended therapy with positive effects on the cognitive performance of older adults with neurocognitive disorders. However, there are few one-on-one, long-term interventions applied by professionals. The aim of the present study was to determine the effectiveness of 47-week individual cognitive stimulation (iCS) interventions on cognition, mood, instrumental activities of daily living, and quality of life in older adults, with neurocognitive disorders using a single-blind, randomized, parallel two-arm RCT. A sample of 59 older adults with neurocognitive disorders (predominantly Alzheimer's disease), who were non-institutionalized but socially vulnerable, was selected. The intervention group (n = 30) received 47 iCS weekly sessions. The control group (n = 29) maintained their baseline treatments. Outcomes were global cognitive function, cognitive impairment, mood, instrumental activities of daily living, and self-reported quality of life. All participants were assessed at baseline, 25 weeks, and 50 weeks. The results showed a significant effect of the intervention on MMSE, MoCA, GDS-15. Individual cognitive stimulation may have beneficial effects on the cognitive function and mood of older adults with cognitive impairment. [ABSTRACT FROM AUTHOR]

We conduct a randomized controlled trial (RCT) to explore whether providing tourists with information about the weather conditions in the destination country has a positive impact on their satisfaction level. We show that providing accurate weather information enables tourists to form more correct expectations i.e. closer to the actual weather conditions in the destination country – which in turn improves their satisfaction and makes them more likely to recommend relatives and friends to make the same trip. These findings reveal the role of information provision in improving tourists’ satisfaction. Finally, our study encourages the application of the RCT approach as it addresses interesting questions in tourism research. [ABSTRACT FROM AUTHOR]

In this paper, we systematically review the efficacy and safety of thrombopoietin receptor agonists (TPORAs) for treatment of persistent and chronic immune thrombocytopenia (ITP) in children and adults. We searched PubMed, MEDLINE, ScienceDirect, Scopus, EMbase and the Cochrane Library to collect randomized controlled trials (RCTs) of TPO-RAs which including avatrombopag hetrombopag eltrombopag and romiplostim treated persistent and chronic ITP from their earliest records to February 2022. We included 15 RCTs with a total of 1563 patients. There were ten trials of adults and five trials of children. The results of meta-analysis showed that in adult patients, patients treated with TPO-RAs had longer duration of platelet response, higher platelet response rate, lower use of rescue therapy, and lower incidence of bleeding events, and similar incidence of adverse events compared with placebo. Except for the incidence of any bleeding, the results in children were consistent with those in adults. The network meta-analysis of data on overall platelet response rates in adults showed that avatrombopag was more effective than eltrombopag and hetrombopag. TPO-RAs has better efficacy and higher safety in the treatment of ITP. And the overall response rate of avatrombopag in adults was higher than that in eltrombopag and hetrombopag. [ABSTRACT FROM AUTHOR]

Online courses have become an increasingly attractive format for delivering teacher training. However, the low retention rates are a critical and still unsolved issue. This paper presents the results of a randomized controlled trial aimed at testing the impact of a personalized support model on teachers' retention in online training courses. The support consisted of a package of nine messages triggered by teachers' characteristics and their specific (in)actions on the course platform. The study involved 3,777 lower-secondary education professional and student teachers from nine European Union Member States and Turkey, who were invited to participate in four new online courses in school year 2018/2019. The experimental estimates show that the offered support increased course completion by 10 percentage points among professional teachers in EU Member States, while it had no effects among student teachers nor in Turkey. Implications for online teacher training providers—such as the importance of reaching out to participants with poor online training experience and who do not start the courses in time—are discussed. [ABSTRACT FROM AUTHOR]

This cross-sectional and longitudinal analysis aimed to demonstrate the disparities in positive results and dissemination patterns of randomized controlled trials (RCTs) in global immuno-oncology (IO). Phase II–IV RCTs with results reported by article publications registered on ClinicalTrials.gov in 2007–2018 studying immune checkpoint inhibitors (ICIs), adoptive cell transfer, cancer vaccines, and immune modulators were included. Twenty-eight percent of trials were positive (72 of 258), most of which were pharma-sponsored and focused on ICI and multiple IO therapies in lung cancer, melanoma, and multiple cancer types. The recent period of trial start year, upfront registration, large sample size, high strictness score on corticosteroid/infection-related criteria, and survival endpoints were associated with positive results. Trials from Mainland China had a faster publication timeline of positive results but lacked study diversity or full reporting of negative results compared with US and multinational trials. Compared with phase II trials, phase III–IV trials had a higher average proportion of positive results (28.9% vs. 22.2%) and a more stable change over the past decade (23.65% vs. 49.24%). Positive trials yielded more secondary manuscripts (10 vs. 4), a shorter publication process of approximately two years (P < 0.001), and a superiority in the dissemination of journals with an h-index >90 (P < 0.001) compared with negative trials. Disparities in positive result dissemination are widespread in IO RCTs and affected by trial features. We proposed improvements in upfront registration, procedural integrity, and adequate inclusion of rival trials reporting negative results within the earlier two years in future reviews. Immuno-oncology (IO) is a novel treatment modality utilizing the natural ability of body's immune system to fight against cancer. The acknowledged standard method to confer the best medical evidence for showing the efficacy of a new intervention is randomized controlled trials (RCTs), and the publication of trial results via journal articles usually modifies medical decisions. A trial labeled negative means that the pre-specified goal was not met, but it deserves more attention rather than a simple interpretation of scientific failure. Previous studies on oncology trials indicated that negative and positive trials have different patterns of result publication and varied trial features. Although IO-related RCTs obtain a continuously increasing number, the extent and tendencies (positive or negative) of their results have not been assessed. To conduct a timely summary and a comprehensive analysis focusing on the publication details and its relationship with the properties of IO trials, we included phase II–IV IO RCTs with results reported by article publications registered on ClinicalTrials.gov in 2007–2018. We found that disparities in positive results and publication are widespread in IO RCTs and severely affected by IO category, cancer type, sponsorship, trial phase, and geographic origin. Positive trials had a significantly shorter publication timeline of approximately two years, more secondary manuscripts, and a superiority in high-quality publications over negative trials. We propose that investigators should complete registration before trial launch, improve procedural integrity, and allow an adequate inclusion of rival trials reporting negative results within the earlier two years in future IO-related reviews. [ABSTRACT FROM AUTHOR]

For many patients including those with psoriasis, scientific manuscripts comprising clinical outcomes including psoriasis area severity index (PASI) and/or physician global assessment (PGA) may be difficult to understand. However, most patients can relate to images at baseline and follow-up, particularly for dermatological diseases. This study aimed to assess the proportion of shared clinical images in psoriasis trials. A systematic review adhering to the PRISMA guidelines was performed. The review was limited to randomized controlled trials, and among these, only investigations involving biological agents for treatment of psoriasis were included. The Embase, MEDLINE and Scopus databases were searched for eligible studies published from inception to October 26, 2021. In total, 152 studies were included. When combining these, 62,871 patients were randomized. Overall, 203 images were shared depicting 60 patients in the manuscripts yielding an overall sharing rate of 0.1%. Patient images are seldom incorporated in clinical trial manuscripts which impairs interpretation for patients. Inclusion of image material would strengthen the patients' perspective and understanding on what treatment effects that can be expected. As such, this systematic review should be an invitation to the pharmaceutical industry, other sponsors, and editorial offices to improve easy transfer of information to patients using image data. [ABSTRACT FROM AUTHOR]

Prenatal stress is a pressing issue. However, there is a lack of robust evidence for psychosocial interventions to manage this problem. This study aimed to examine the effectiveness of a mindfulness-based intervention on reducing prenatal stress compared to participation in health education groups. A randomized controlled trial was conducted in a prenatal clinic of comprehensive tertiary care from April to October 2017. A total of 108 pregnant women were randomly assigned to an intervention or a control group. Participants completed self-report measures of depression, anxiety, perceived stress, fatigue, positive and negative affect, and mindfulness before, immediately after, and 15 weeks after the 4-week intervention period. Generalized estimating equations were used to analyze the intervention outcomes. The results supported greater improvement in terms of perceived stress (Wald χ2=26.94, p<0.001), fatigue (Wald χ2=17.61, p<0.001), positive affect (Wald χ2=9.03, p = 0.011), negative affect (Wald χ2=11.37, p = 0.003), and mindfulness (Wald χ2=24.97, p<0.001) in the intervention group than in the control group. The self-help mindfulness intervention decreased prenatal stress and negative affect and improved positive affect and mindfulness. [ABSTRACT FROM AUTHOR]

Introduction: Evidence-based services to support cancer patients with pain via clinical pharmacy services are currently lacking. Therefore, there is a need to undertake a randomized controlled trial (RCT) to explore the effectiveness of clinical pharmacists (CPs)' input into the multidisciplinary team (MDT) in providing better therapeutic outcomes for cancer pain management. Objectives: The main aim of this pilot RCT is to determine the feasibility and preliminary efficacy of integrating CPs into the MDT for cancer pain management on the clinical outcomes of cancer patients experiencing pain. Methods: This study protocol outlines two-armed multicenter pilot RCT. Cancer patients suffering from pain will be randomly allocated to receive either clinical pharmacy services, i.e., PharmaCAP trial intervention from the CP, or the usual standard care (i.e., control group). Patients will be recruited consecutively from two hospitals in Kathmandu valley, Nepal. The outcomes will be assessed at baseline (pre-intervention) and 4 weeks post-intervention. The primary feasibility outcomes will include eligibility rate, recruitment rate, willingness to participate, acceptability of screening procedures and random allocation, possible contamination between the groups, intervention fidelity and compliance, treatment satisfaction, and patient understanding of the provided interventions. Subsequently, the primary clinical outcome, i.e., pain intensity of cancer patients, will be assessed. The secondary clinical outcomes will include health-related quality of life (HRQoL), anxiety, depression, adverse drug reactions, and patient medication compliance following the integration of CP into the healthcare team. Discussion: The feasibility and potential for integrating CP involvement in MDT to improve clinical outcomes of cancer patients with pain will be evaluated through the PharmaCAP trial. Trial registration: ClinicalTrials.gov NCT05021393. Registered on 25th August 2022. [ABSTRACT FROM AUTHOR]

Self-compassion is the ability to offer oneself kindness and compassion in response to failure, suffering, or insecurity. Learning how to be self-compassionate through self-compassion training appears effective for improving psychological well-being in community samples and promising for clinical populations. The current randomized controlled trial was designed to (a) examine the effectiveness of a self-guided self-compassion training program; and (b) determine whether self-compassion training can help mitigate social anxiety disorder (SAD) symptoms. Adults with SAD (n = 63; Mage = 34.3, SD = 11.4; 67.8% female; 84.7% Caucasian) were randomized to a waitlist control condition, a self-guided self-compassion training condition, or a self-guided applied relaxation training condition for six weeks. Outcome measures of SAD symptoms and self-compassion were completed pre-, mid-, and post-treatment, as well as at 3-months follow-up. Multilevel linear modelling results suggested the self-compassion training program was statistically superior at improving outcome measures relative to the waitlist control condition (ps <.05; η2ps =.12–.33), but not relative to the applied relaxation training condition (ps >.05; η2ps =.01–.05). Self-compassion training produced greater clinically significant gains in self-compassion and reductions in fear of self-compassion compared to both the waitlist condition and applied relaxation training. The current trial provides preliminary evidence for the effectiveness of a self-help self-compassion training program and provides evidence that self-compassion training may be beneficial for managing clinically significant SAD symptoms. [ABSTRACT FROM AUTHOR]

Technology-assisted Cognitive Behavioral Therapy (tCBT) has significant potentials to provide engaging and accessible depression treatment for adolescents and young adults (AYAs) coping with cancer. This study evaluated the feasibility and preliminary efficacy of an engaging and tailorable tCBT – Mind Your Total Health (MYTH) – for AYA cancer survivors' depression. Seventeen AYAs diagnosed with cancer were randomly assigned to either the intervention (MYTH) or control group. The intervention group (n = 10) received eight weekly 30-35 minutes coach-assisted tCBT (MYTH), while the control group (n = 7) received active control, BeatingtheBlues (BtB). Eight out of ten participants in the MYTH group completed at least six out of eight sessions, suggesting strong feasibility (80% completion rate) among AYAs with cancer. Efficacy outcomes indicated that participants in the MYTH group reported significant pre- and post-treatment reduction in depression, t(9) = 5.25, p < 0.001, and anxiety, t(9)=5.07, p < 0.001. Notably, participants in the MYTH group reported significantly lower post-treatment depression than participants in the BtB group, t(15) = 2.40, p < 0.05. The between-group difference reflected a significant between-group treatment effect size, d = 1.12, p < 0.05. This engaging, tailorable, and coach-assisted tCBT intervention is promising in alleviating depression and anxiety among AYA cancer survivors. Future research needs to include larger sample size and a more diverse patient population. [ABSTRACT FROM AUTHOR]

The slow pace of improvement in service delivery and health outcomes for pregnant women and newborns in developing countries has been a major concern for policy makers in recent decades. This paper presents the results from a randomized controlled trial of a community health worker program designed to enhance uptake of child and maternal health services in Northern Nigeria. Three interventions were evaluated: the deployment of community health educators, health educators with the provision of safe birth kits, and health educators with community dramas. The results suggest that the interventions increased utilization of antenatal, postnatal, and infant care. Maternal and newborn health practices improved as well as health knowledge. In addition, the community health worker program was more effective when supplemented with additional program components. [ABSTRACT FROM AUTHOR]

Despite overwhelming adoption of wearable fitness trackers (WFT), it is unclear if they affect physical activity (PA) engagement or PA motivation. We hypothesized that combining a WFT with an effective intervention, motivational interviewing (MI), would positively influence both motivation and PA. A 12-week randomized controlled trial was conducted in 40 adults who did not meet PA recommendations. The four conditions were: a PA education (Educational control, n = 10), a WFT (WFT, n = 10), bi-weekly MI sessions (MI, n = 10), or both interventions (WFT+, n = 10). Motivation and PA were measured through an online survey and actigraphy pre- and post-intervention. Both the WFT+ and MI groups improved autonomous forms and decreased controlled forms of motivation. They also had higher basic psychological needs scores when compared to the Education group post-intervention. We detected no changes in PA. High autonomous motivation at baseline predicted higher post-intervention PA in the WFT+ group but predicted lower post-intervention PA in the WFT group. Results suggests that MI alone or with a WFT can improve basic psychological needs and autonomous forms of motivation for PA, but not PA participation. Individual differences in motivation at baseline may moderate the effect of a WFT on PA. This study was registered at clinicaltrials.gov (NCT490014). [ABSTRACT FROM AUTHOR]

In this randomized controlled trial with controls for student characteristics, the authors used a loss-aversion strategy to test whether students achieve greater learning gains from combining research-based instructional strategies with loss aversion. Students in the control group began the class with no grades and built their course average by completing assignments and exams. The treatment group began with a score of 100 percent on each assignment and viewed the deductions on scores from errors and missed work. The results indicated that students in the treatment group experienced gains in learning that were, on average, 5 to 13 percentage points larger than those of the control group. These learning gains were concentrated among students with low SAT math scores. [ABSTRACT FROM AUTHOR]

Background: Involving patients and consumers in research design helps ensure relevance for those affected by the problem being investigated and can optimize recruitment to clinical trials. This is particularly important when conducting research involving pregnant women. Aims: We investigated women's motivations to participate in a hypothetical randomized control trial (RCT) of a third-trimester screening test for intrapartum fetal compromise (IFC) and adverse perinatal outcomes. Materials and methods: Women attending for routine antenatal care at a tertiary center were invited to complete a short, anonymized patient acceptability survey. The survey was developed with the assistance of the Perinatal Society of Australia and New Zealand's Consumer Advisory Panel and consisted of Likert scales and open-ended questions. It was designed to ascertain women's responses to research issues, particularly the acceptability of being randomized to a non-revealed arm of a screening test RCT. Results: 100 pregnant women took part; 40% indicated that they would agree/strongly agree to participate in a hypothetical RCT regardless of whether they were given the result of a screening test and 31% were unsure. Randomization to either an intervention or control group was acceptable to 47%, 30% were unsure and 23% were not willing to be randomized. Reasons to participate included the desire to contribute to research and to improve pregnancy care. Conclusions: Participation in an RCT of a screening test for IFC involving non-disclosure of the test result was acceptable to a large minority of pregnant women. This finding supports the feasibility of conducting a large-scale study of this design. [ABSTRACT FROM AUTHOR]

Introduction This study aimed to assess satisfaction of patients affected by various fluid regimes during uncomplicated labor; to identify factors possibly associated with the level of satisfaction; to compare obstetrical and neonatal outcomes between the intervention groups. Methods Between October and December 2014, 40 women were included in the study set at the Poitiers University Hospital, France. Women were randomly allocated to two study arms: 20 to strict and 20 to liberal fluid regime group. Women’s satisfaction was assessed using visual analog scale. Categorical obstetrical and neonatal outcomes were analyzed using Chi-squared test and Fischer’s exact test. The between-group difference was assessed with Mann–Whitney U-test. Results Overall satisfaction was higher among women from the liberal fluid regime than from the strict fluid regime group (median score: 88, interquartile range [IQR]: 21 vs. 72, IQR: 21; p = 0.03). The active phase of the second stage of labor was shorter in the liberal fluid regime than in the strict fluid regime group (median 9 min, IQR: 7 vs. 17 min, IQR: 12; p = 0.02). The length of stay in the delivery room was significantly shorter in liberal fluid regime than in strict fluid regime group (median 190 min, IQR: 128 vs. 340 min, IQR: 195, p = 0.04). There were no significant differences in other obstetrical and neonatal outcomes. Conclusion Liberal fluid regime during labor was associated with significantly higher satisfaction of women. The active phase of the second stage of labor and the length of stay in the delivery room were significantly shorter in the liberal fluid regime group. [ABSTRACT FROM AUTHOR]

The effectiveness of Manual Therapy (MT) in thumb carpometacarpal osteoarthritis (OA) is unclear. This study aimed to determine the effectiveness of MT for functional outcomes in patients with thumb carpometacarpal OA. Systematic review and meta-analysis of randomized clinical trials. 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 compared MT versus other interventions in functional outcomes, such as thumb and/or hand function questionnaires, pinch and/or grip strength, thumb and/or hand range of motion, and pain intensity or pressure pain threshold in patients with thumb carpometacarpal OA. Five clinical trials met the eligibility criteria; for the quantitative synthesis, four studies were included. The mean difference (MD) for grip strength was 0.87kg (95% CI = 0.29–1.44, p =.003), for pinch strength was 0.10kg (95% CI = –0.01–0.20, p =.06), and for the pressure pain threshold was 0.64kg/cm2 (95% CI = 0.07–1.20, p =.03). All differences were in favor of the MT group. In the short-term, there was moderate to high evidence, with statistically significant differences in the functional outcomes, in favor of MT versus sham interventions in patients with thumb carpometacarpal OA. However, these differences are not clinically important. [ABSTRACT FROM AUTHOR]

Postmenopausal women with overweight or obesity have an increased risk of developing breast cancer but many of the mechanisms underlying this association remain to be elucidated. MicroRNAs (miRNAs), short non-coding single-stranded RNAs, regulate many physiological processes by controlling posttranscriptional regulation of mRNA. We measured circulating miRNA from 192 overweight/obese postmenopausal women (50-75 years) who were part of a randomized controlled trial, comparing independent and combined effects of a 12-month reduced-calorie weight-loss diet and exercise programme, versus control. RNA was extracted from stored plasma samples, and 23 a priori selected miRNA targets related to aetiology of breast cancer or obesity were measured using NanoString nCounter miRNA Expression assays. Changes from baseline to 12-months between controls and women in the diet/exercise weight loss arms were analysed using generalized estimating equations modification of linear regression, adjusted for confounders. We next examined changes in levels of circulating miRNA by amount of weight loss (0-10% versus =10%). Participants randomized to weight-loss interventions had statistically significantly greater reductions in miR-122 (-7.25%), compared to controls (+ 33.5%, P = 0.009), and miR-122 levels were statistically significantly correlated with weight loss (rho = 0.24; P = 0.001) Increasing weight loss was associated with greater reductions in miR-122 vs. controls (-11.7% (=10% weight loss); +2.0% (0-10% weight loss) +33.5% (controls); Ptrend = 0.006), though this was not significant after correction for multiple testing (P = 0.05/23) Our study supports the effect of weight loss on regulation of miRNA. [ABSTRACT FROM AUTHOR]

It is believed that clinical management of osteoarthritis should address muscle weakness to improve physical function and prevent disability and frailty This sub-study investigated the effects of supervised progressive resistance training (RT), supervised Nordic Walking (NW), and unsupervised home-based exercise (HBE) on muscle and functional performance; and associations between these exercise-induced changes in persons with hip osteoarthritis. Forty-two patients with hip osteoarthritis were recruited from a larger RCT (NCT01387867). All the groups (RT, n = 15; NW, n = 12; HBE, n = 15) exercised 1 h 3 times/week for 4 months. Quadriceps cross-sectional area (QCSA, MRI-determined); quadriceps strength (QMVC); leg extensor power (LEP); functional performance (chair stands (30sCS); stair climbs (TSC); and 6-minute walk (6MWT)) were assessed at baseline and 4 months. Per protocol analyses (one-way ANOVA and Bonferroni test) showed significant between-group differences for improvements in QCSA in the most symptomatic leg favoring RT versus NW (2.3 cm2, 95% CI [0.6, 3.9]) and HBE (2.3 cm2 [0.8, 3.9]); and 30sCS (1.8 repetitions [0.2–3.3]), and 6MWT (35.1 m [3.5–66.7]) favoring NW versus HBE. Associations existed between exercise-induced changes in QCSA and QMVC (r = 0.366, p =.019) for the most symptomatic leg and between changes in 6MWT and QMVC (r = 0.320, p =.04) and LEP (r = 0.381, p =.01), respectively, for the least symptomatic leg. Resistance training appeared effective for improving muscle mass, but less effective for improving muscle strength, power, and functional performance. Only exercise-induced changes in muscle strength and power of the least symptomatic leg, not the most symptomatic leg, were related to changes in functional performance. [ABSTRACT FROM AUTHOR]

This article studies inference for the average treatment effect in randomized controlled trials where treatment status is determined according to a "matched pairs" design. By a "matched pairs" design, we mean that units are sampled iid from the population of interest, paired according to observed, baseline covariates and finally, within each pair, one unit is selected at random for treatment. This type of design is used routinely throughout the sciences, but fundamental questions about its implications for inference about the average treatment effect remain. The main requirement underlying our analysis is that pairs are formed so that units within pairs are suitably "close" in terms of the baseline covariates, and we develop novel results to ensure that pairs are formed in a way that satisfies this condition. Under this assumption, we show that, for the problem of testing the null hypothesis that the average treatment effect equals a prespecified value in such settings, the commonly used two-sample t-test and "matched pairs" t-test are conservative in the sense that these tests have limiting rejection probability under the null hypothesis no greater than and typically strictly less than the nominal level. We show, however, that a simple adjustment to the standard errors of these tests leads to a test that is asymptotically exact in the sense that its limiting rejection probability under the null hypothesis equals the nominal level. We also study the behavior of randomization tests that arise naturally in these types of settings. When implemented appropriately, we show that this approach also leads to a test that is asymptotically exact in the sense described previously, but additionally has finite-sample rejection probability no greater than the nominal level for certain distributions satisfying the null hypothesis. A simulation study and empirical application confirm the practical relevance of our theoretical results. [ABSTRACT FROM AUTHOR]

Linked colour imaging (LCI) is a novel new image-enhanced endoscopy (IEE) technology that produces bright and vivid images. The aim of this study was to assess the ability of LCI to improve the diagnostic accuracy of early gastric cancer (EGC) relative to white light imaging (WLI). We performed this study on patients undergoing screening endoscopy from 12 medical institutions in China. Patients were randomly assigned to receive WLI followed by LCI or LCI followed by WLI. The primary outcome was to compared the diagnostic accuracy between LCI and WLI for EGC/high-grade intraepithelial neoplasms. Secondary outcomes included the numbers of suspicious lesions, neoplastic lesions and examination time by using LCI detected versus using WLI. A total of 1924 patients were randomly selected, and 1828 were included in the analysis. The diagnostic accuracy for EGC, which was 78.8% by using LCI and 68.4% by using WLI (p <.0001). More suspicious lesions were detected by LCI than by WLI (n = 1235 vs. 1036, p =.031), especially among differentiated EGC (p =.013). LCI greatly shortened the examination time compared with WLI (p =.019). LCI has better accuracy and shorter examination time in diagnosing EGC than WLI (Clinical trial registration: NCT03092414). Compared with white light imaging (WLI), the diagnostic accuracy, sensitivity and specificity increased by using LCI. More lesions were detected by LCI alone than by WLI alone, especially among differentiated EGC. LCI may be used as a screening tool for routine clinical observation. [ABSTRACT FROM AUTHOR]

To figure out the efficacy, effects, safety and patient's subjective perceptions of phacoemulsification with the active-fluidics system (AFS). This was a prospective, randomized, double-masked, controlled clinical study. Age-related cataract patients were recruited and randomly assigned to the AFS group and gravity-fluidics system (GFS) group in a ratio of 1:1 to have phacoemulsification. Participants were followed up at one day, one week, one month and three months postoperatively (Chinese Clinical Trial Registry, ChiCTR2100044409). The overall included participants were 107 finally. The total aspiration time of the AFS group was significantly less than that of the GFS group (p =.020), while no significant difference existed in cumulative dissipated energy and estimated fluid usage between the two groups. The best corrected visual acuity was significantly better in the AFS group at one day and one week postoperatively (p =.002, p =.038 respectively). The recovery of central corneal thickening and macular superficial vasculature increase was earlier in the AFS group. The central retinal thickness was significantly higher in the GFS group at one month and three months postoperatively (p =.029, p =.016 respectively). The incidence of corneal adverse events was higher in GFS group (p =.035). No serious adverse events occurred in either group. Pain scores and the scores of Cat-PROM5 questionnaire of the AFS group were significantly lower than that of the GFS group (p =.011, p =.002 respectively). AFS improves the efficiency, effects, safety and patients' subjective perceptions of phacoemulsification compared with GFS. It is worthwhile to promote its application in cataract surgery. The active-fluidics system automatically detects and maintains stable intraocular pressure at the set value. The active-fluidics system improves the efficiency, effects, safety and patients' subjective perceptions in phacoemulsification. [ABSTRACT FROM AUTHOR]

The publication of A Randomized Trial of Induction Versus Expectant Management (ARRIVE), conducted in the United States in 2018, heralded a paradigm shift within the obstetrical management of term pregnancy among people who have not previously given birth. ARRIVE finds its home among other canonical – and controversial – randomized controlled trials (RCTs) within obstetrics. We argue that RCTs have their own (after)life, both creating new subjects for biomedical intervention and recalibrating who reproductive health practitioners consider to be at risk of adverse health outcomes. These data have important consequences for medical social scientific engagement with RCTs to further interrogate the questions of risk and intervention within reproductive health. [ABSTRACT FROM AUTHOR]

Objective: To determine the effectiveness of a 13-week individual reminiscence therapy (RT) intervention on cognition, memory, executive function, mood, and quality of life of people with Alzheimer's disease and vascular dementia. Method: Non-protocolized analysis using data from a larger multicenter, single-blind, randomized, parallel two-arm RCT of RT for people with neurocognitive disorders. A sample of 148 people with probable Alzheimer's disease or vascular dementia attending 23 Portuguese institutions providing care and support services for older adults were selected. Intervention group (n = 74) received 26 individual RT sessions, twice a week for 13 weeks. Control group (n = 74) maintained their treatment as usual. Outcomes were global cognitive function (MMSE), memory (MAT), executive function (FAB), mood (GDS-15), and self-reported quality of life (QoL-AD). All participants were assessed at baseline (T0) and 15 weeks later (T1). Results: The results showed a significant effect of the intervention on global cognition (Group X Time interaction F(1, 128) = 10.542, p =.001, ηp2 =.076), memory (F(1,128) = 9.881, p =.002, ηp2 =.072), and quality of life (F(1,128) = 0.181, p =.671, ηp2 =.001), with medium effect sizes. A small effect on executive function (F(1,127) = 11.118, p =.001, ηp2 =.080) was also found. No effects were found on depressive symptoms (F(1,128) = 0.181, p =.671, ηp2 =.001). Conclusion: Individual RT may have beneficial effects on cognition and quality of life of people with Alzheimer's disease or vascular dementia. [ABSTRACT FROM AUTHOR]

To investigate the efficacy of a tailored counselling intervention for injured workers regarding different aspects of subjective well-being. Prospective randomized controlled trial with 192 mildly-to-moderately injured workers who were on sick leave for at least 18 weeks and showed a high-risk profile for a complicated rehabilitation process in a screening. Patients were assessed at baseline, 12 and 18 months post-injury. The outcome variables concerned five aspects of subjective well-being (negative feelings, life and job satisfaction, satisfaction related to family and health). Both the control and the experimental group received conventional case management. Participants in the intervention group additionally received tailored workplace interventions and/or mental health counselling sessions. Participants in the intervention group received an average of 2.23 (SD = 6.94) counselling sessions. Both groups showed a significant reduction (mean (95% CI) of negative feelings control group 2.6 (2.3–3.4), intervention group 2.4 (1.6–3.4)), with a significant difference in negative feelings between the groups (p = 0.01). Our results suggest that a tailored counselling intervention has a modest long-term effect (d = 0.74) on negative feelings for mildly-to-moderately injured workers. However, future studies should evaluate the feasibility of this study's treatment approach. Accidents and the resulting injuries often cause a wide range of burdens including psychosocial and emotional distress as well as long-time sick leaves. Tailored counselling led to significant reductions of negative feelings in mildly-to-moderately injured workers over time. By showing that even conventional case management can have a beneficial effect on subjective wellbeing, the results of this study reaffirm the holistic biopsychosocial nature of injury rehabilitation. [ABSTRACT FROM AUTHOR]

We conducted a cross-sectional analysis of ClinicalTrials.gov-registered oncology randomized controlled trials between September 2019 and December 2021 to identify predictors of trial suspensions. The dataset included 1,183 oncology trials, of which 384 (32.5%) were suspended. COVID-19 accounted for 47 (12.2%) suspensions. Trials that were single center- or US-based had higher odds of COVID-19 (ORs: 3.85 and 2.48, 95% CIs: 1.60–11.50 and 1.28–4.93, respectively) or any-reason suspensions (ORs: 2.33 and 2.04, 95% CIs: 1.46–3.45 and 1.40–2.76, respectively). Phase two (OR 1.27), three (OR 6.45) and four trials (OR 11.5) had increased odds of COVID-19 suspensions, compared to phase one trials. [ABSTRACT FROM AUTHOR]

This paper reports the outcomes of an experimental evaluation of Direct Instruction Spoken English (DISE), an English language curriculum that focuses on developing English speaking, listening, and comprehension skills in English Learners (ELs). Twenty-nine middle schools in three states were randomly assigned to teach DISE Level 1 or their typical English language development program. Treatment teachers received two days of training and taught daily lessons. Project staff assessed 746 sixth and seventh-grade students with a proximal measure of English language proficiency and distal measures of language and oral reading fluency. Analyses of oral English language suggested differences between intervention conditions favored the DISE condition for students who began with lower English language proficiency and accumulated when taught over two years. Differences between intervention conditions were not observed after only one year of instruction and for students with advanced levels of English language proficiency. The findings suggest that an evidence-based English oral language program that included frequent teacher demonstrations and opportunities for students to practice speaking English may improve English oral language skills for middle school students. Supplemental data for this article is available online at https://doi.org/10.1080/10824669.2022.2045993. [ABSTRACT FROM AUTHOR]

Physical activity reduces risk of colon cancer by 20–30%. Aberrant methylation patterns are common epigenetic alterations in colorectal adenomas, and cancers and play a role in cancer initiation and progression. Alterations identified in normal colon tissue represent apotential 'field cancerization' process, where normal colon is primed for carcinogenesis. Here, we investigate methylation patterns in three genes –Ena/VASP-like (EVL), (CDKN2A (p14, ARF)), and Oestrogen Receptor-1 (ESR1)– in normal colon tissue collected at baseline and 12 months from 202 sedentary men and women, 40–75 years, enrolled in a randomized controlled trial testing an exercise intervention vs. control (). Participants were randomized to moderate-to-vigorous intensity exercise, 60 minutes/day, 6 days/week for 12 months, or usual lifestyle. Sigmoid colon biopsies were obtained at baseline and 12-months, DNA extracted, and bisulphite converted. Droplet digital methylation-specific PCR was performed for EVL, p14ARF, and ESR1. Generalized estimating equations modification of linear regression was used to model relationships between intervention effects and gene methylation levels, adjusting for possible confounders. There were no statistically significant differences between methylation patterns at 12-months between exercisers and controls. ESR1 methylation patterns differed by sex: women −10.58% (exercisers) +11.10% (controls); men +5.54% (exercisers), −8.16% (controls) (P=0.05), adjusting for BMI and age. There were no statistically significant changes in methylation patterns in any gene stratified by change in VO2max or minutes/week of exercise. While no statistically significant differences were found in gene methylation patterns comparing exercises vs. controls, 12-month exercise effects on ESR1 methylation differed by sex, warranting further study. [ABSTRACT FROM AUTHOR]

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]