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Background: Early language delay is exacerbated by social disadvantage. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. Methods used to achieve successful health outcomes in socially disadvantaged clinical populations may need enhancing. Aims: To compare the impact of standard parent‐based intervention (PBI) to enhanced PBI for young children with speech, language and communication needs (SCLN) and their families living in more socially disadvantaged populations. Methods and Procedures: A multicentre clustered blind randomised controlled trial was used to compare the effect of parent‐based group interventions to improve early language development with children (mean age 27.5 months) from more socially disadvantaged populations with an expressive vocabulary of 40 or less single words. Intervention sessions were delivered by a speech and language therapist, over a 20‐week period. Participants received one of two interventions: (1) Standard Care – indirect group PBI – (PBI) (2) Enhanced Care: indirect group enhanced PBI – (EPBI). Both standardised and non‐standardised measures were used as outcomes. Parent engagement in the intervention was captured through analysis of attendance and the Parent Activation Measure – Speech & Language Therapy (PAM‐SLT) (Insignia Health, 2014). The PAM measures a person's knowledge, skills and confidence to manage their own health and well‐being (NHS England, 2018). In this study, activation referred to parents' knowledge, skills and confidence to manage their child's language development. Outcomes and Results: One hundred fifty‐five participants were randomised at baseline. Children in both groups made significant improvements in the outcome on MacArthur‐Bates Communicative Development Inventories Sentence Length, from pre‐intervention to post‐intervention and 6 months post‐intervention (p < 0.05). Changes in vocabulary and expressive language skills were more equivocal, showing wide variation in confidence intervals for both groups. Where parents attended at least one intervention session almost all effect sizes were in favour of the EPBI intervention. Parents' activation levels significantly increased for both groups (EPBI p < 0.001, PBI p = 0.003), with a moderate effect size in favour of EPBI (Hedges' G 0.37, confidence interval –0.02 to 0.76), although wide variation was found. Conclusions and Implications: This trial provides some evidence of facilitating the language development of children with SLCN from more socially disadvantaged areas through supporting caregivers. However, we found variation in outcomes; some children made excellent progress, whilst others did not. Further exploration of parent engagement and its relationship to child language outcomes will be valuable to understanding more about mechanisms of change in interventions that involve parents. WHAT THIS PAPER ADDS: What is already known on the subject: Speech, language and communication needs (SLCN) have a knock‐on effect on emotional well‐being, school readiness, literacy and school attainment, putting children at increased risk of long‐term consequences such as poor literacy, mental health problems and unemployment. In disadvantaged areas, the prevalence of language difficulties is higher than elsewhere. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. What this paper adds to existing knowledge: Children with SLCN from more socially disadvantaged areas can make improvements in their language development through parent intervention, although wide individual variation was found. There was some evidence that children achieve better outcomes with EPBI, which employed an interagency collaborative approach. Parent's engagement (activation levels) increased significantly over time with intervention, with the increase twice as big for EPBI. What are the potential or actual clinical implications of this work?: This trial provides some evidence that it is possible to facilitate the language development of children from more socially disadvantaged areas through supporting their caregivers. Further research would be useful to determine whether increases in parent engagement are related to adherence to intervention and change in child outcomes. [ABSTRACT FROM AUTHOR]

Background Study: Virtual reality (VR) is becoming a popular technology for safety training in construction. Several VR training prototypes have been designed and tested, which show they can perform better than traditional training tools. However, most of these existing tools are not underpinned by clear pedagogical theory, and studies assessing the impact of pedagogical theories on the effectiveness of VR prototypes are still rare in the literature. Objectives: This study aims to investigate if and how the productive failure theory and the directive instruction theory have an impact on the effectiveness of VR safety training for confined space workers. Methods: The study used a randomized controlled method involving 74 participants. The effectiveness of these two training methods was assessed in terms of knowledge acquisition and retention. Results and Conclusions: The results illustrate that the productive failure training design performed better in terms of knowledge acquisition and retention. This paper introduces the Productive Failure Theory and shows the great potential of this approach for self‐service VR safety training in the field of construction. Lay Description: What is already known about this topic: PF has been proven effective in classroom‐based teaching practice.PF has been proven effective in non‐immersive virtual training.DI is a commonly used pedagogical method for VR training. What this paper adds: The present paper investigates the feasibility of applying PF theory in VR safety training.The present paper examines the pedagogical impacts of the two pedagogical approaches within VR serious games. Implications for practice and/or policy: PF can be applied to self‐help VR safety training, reducing the demand for resources such as teaching staff and venues.PF training design performed better in terms of knowledge acquisition and retention.PF has great potential for self‐help VR safety training in various fields. [ABSTRACT FROM AUTHOR]

An important cause of stunting is limited consumption of complementary foods, in terms of both quantities and nutrients. Although existing studies show a positive association between fathers' engagement and children's diet, programmes designed to improve complementary feeding practices often only target mothers. In response to this, maternal behaviour change communication (BCC), paternal BCC and food voucher programmes were designed and implemented in Ethiopia using a clustered randomized controlled trial design. The paternal BCC programme included gender‐equal messages to increase fathers' participation in childcare, household labour and decision making. The research reported in this paper is an examination of the BCC programmes, characterizing the behavioural, normative and control beliefs of both mothers and fathers in BCC households compared to those in control households. In this study, a total of 40 participants were included, with 13 mother–father pairs in the BCC + food voucher group, and seven pairs in the control group. Each participant was interviewed separately. We found that BCC mothers showed more gender‐equal tendencies than the control mothers despite being more rural in location. By contrast, the beliefs of BCC and control fathers were similar overall, suggesting men are more resistant to gender‐equal BCC. More work is needed to develop and test effective methods for changing fathers' beliefs and practices. Key messages: Mothers in behaviour change communication (BCC) group mothers held more gender‐equal beliefs than control mothers, while BCC and control fathers shared similar views, suggesting a male resistance to gender equality.Mothers found fathers' involvement in childcare socially acceptable but often perceived them as inexperienced, which limited their participation.Control mothers' traditional view on household chores maintained the conventional labour division, influencing fathers' involvement.Fathers typically resisted maternal control of resources; however, they agreed that the more knowledgeable should lead decision‐making. BCC mothers showed greater confidence in making household decisions as effectively as fathers. [ABSTRACT FROM AUTHOR]

Background: A promising way to obtain vocal economy and efficiency is by semi‐occluding the vocal tract while phonating. Current knowledge about the immediate effects of semi‐occluded vocal tract (SOVT) phonation on the laryngeal function and configuration is based mainly on computer modelling or excised larynges studies. In in vivo SOVT studies, electroglottography (EGG) has been the most commonly used laryngeal outcome, showing contradictory results between studies. Therefore, exploring these aspects by direct visualisation of the human larynx during SOVT phonation using strobovideolaryngoscopy (SVL) is needed. Aims: The aim of this study was to investigate and compare the immediate effects of straw phonation (SP) in air, SP in 2 cm water, and SP in 5 cm water (with stirring straws), on the laryngeal function and configuration of a homogeneous group of vocally healthy female speech‐language pathology students, visualised with flexible SVL. Methods & Procedure: A randomised controlled trial was used. Fifty‐two female speech‐language pathology students (mean age: 18.7 years, SD: 0.6) were assigned randomly to one of three experimental groups or a control group: (1) SP in air, (2) SP in 2 cm water, (3) SP in 5 cm water or (4) [u] phonation with similar soft onset and slightly pursed lips as in SP but without a straw (control group). The participants underwent flexible SVL during habitual [u] phonation, followed by the specific SOVT exercise of their group assignment. All video samples were evaluated randomly and blindly by two experienced investigators using the Voice‐Vibratory Assessment with Laryngeal Imaging (VALI) rating form, first independently and then by consensus. Outcome & Results: Compared to habitual phonation, the vibrational amplitude decreased during SP in 5 cm water and SP in 2 cm water, being more prominent in the first, more flow‐resistant exercise. The mucosal wave also decreased during SP in 5 cm water. The anteroposterior (AP) supraglottic compression similarly increased during SP in air, SP in 2 cm water, and SP in 5 cm water. Further, a rise in mediolateral (ML) compression and a decrease in phase symmetry and regularity were found during SP in 2 cm water. A similar decrease in regularity was observed during SP in 5 cm water. Conclusions & Implications: Both SP in air and SP in water cause positive immediate laryngeal effects for voice training opportunities. More AP supraglottic activity found during each SP exercise might indicate epilarynx narrowing, an economic phenomenon associated with SOVT. Immersing the straw in water additionally diminished the vibrational amplitude, lowering vocal fold impact stress and risk for phonotrauma during the exercise. The decreased regularity of the vibrational cycles during SP in water might be due to the varying back pressure created by the water bubbling. The impact of SP in water on ML supraglottic compression needs further investigation. What This Paper Adds: What is already known on the subject: A promising way to obtain vocal economy and efficiency is by semi‐occluding the vocal tract while phonating. Current knowledge about the immediate effects of semi‐occluded vocal tract (SOVT) phonation on the laryngeal function and configuration is based mainly on computer modelling or excised larynges studies. In in vivo SOVT studies, electroglottography (EGG) has been the most commonly used laryngeal outcome, showing contradictory results between studies. Therefore, exploring these aspects by direct visualisation of the human larynx during SOVT phonation using strobovideolaryngoscopy (SVL) is needed. What this paper adds to existing knowledge: Group results of the current study generally support earlier computer modelling and in vivo studies, strengthening the current SOVT knowledge. Both SP in air and SP in water cause positive immediate laryngeal effects for voice training opportunities. More anteroposterior (AP) supraglottic activity found during each SP exercise might indicate epilarynx narrowing, an economic phenomenon associated with SOVT. Immersing the straw in water additionally diminished the vibrational amplitude, lowering vocal fold impact stress and risk for phonotrauma during the exercise. The decreased regularity of the vibrational cycles during SP in water might be due to the varying back pressure created by the water bubbling. The impact of SP in water on ML supraglottic compression needs further investigation. What are the potential or actual clinical implications of this work?: Current results support that both SP in air and SP in water can be useful exercises in voice training. SP in water has shown the additional gain of lowering the vibrational amplitude during the exercise, hence supporting its appropriateness for vocal warm‐ups by minimising vocal fold impact stress and the risk of phonotrauma. In the future, large‐scale randomised controlled trials in other subgroups of voice users, including dysphonic patients, are needed to support evidence‐based practice. SVL can facilitate the search for individualised training and therapy approaches. [ABSTRACT FROM AUTHOR]

Background: Continued professional development (CPD) is required for updated skills and knowledge. This study evaluates the efficacy of a CPD programme for mainstream school teachers. Aims: In an 11‐week intervention programme, speech–language therapists (SLTs) presented the participating teachers with whole‐class teaching techniques aimed at creating a language and communication‐supporting classroom environment. The effects of the intervention on the language development of the students in the teachers' classes were assessed. Methods & Procedures: A total of 211 first‐ and second‐year students (Mage = 7;6, range = 6;5–8;9) underwent standardized language assessments of receptive and expressive language abilities before and after their teachers' participation in the CPD. The students were divided into intervention and delayed intervention groups to enable randomized intervention allocation. Linear mixed modelling was used to estimate the individual and interaction effects of group, time and demographic factors. Outcomes & Results: Significant effects of time, group and school, respectively, but no interaction between time and group indicates that while all students advanced between assessments, the progress was not attributable to the teachers' participation in the CPD. Conclusions & Implications: Results are discussed in light of those of recent studies of universal services to support optimal language development. WHAT THIS PAPER ADDS: What is already known on this subject: Although inconclusive, previous research indicates that intervention delivered to teachers by SLTs has the potential to improve the language abilities of the students in the teachers' classrooms. What this paper adds to existing knowledge: This study explored the language development of first‐ and second‐year mainstream school students whose teachers took part in a CPD programme aimed at establishing language and communication‐supporting teaching techniques. Results indicate that the development of the students' language abilities could not be attributed to the teachers' participation in the CPD. What are the potential or actual implications of the work?: SLTs are often asked to guide teachers and teaching staff rather than themselves conduct individual assessments and interventions. The results of this trial can be used to inform the discussion on how to prioritize between tasks. [ABSTRACT FROM AUTHOR]

Background: Digital game‐based learning is gaining increased attention from both researchers and educators for improving mathematics instruction. However, the evidence for game‐based learning is mixed and research with rigorous research design and analyses are limited. Objective: Here, in a pre‐registered randomized controlled study, we investigated whether a fraction game designed collaboratively by educational experts and professional game developers may serve as a useful tool to enhance students' fraction knowledge. Methods: We assigned French fifth graders to either an experimental group who used the game (n = 110) or a control group (n = 78) who received traditional instruction on fractions. Fraction knowledge was assessed pre‐ and post‐intervention. Results: Results show that students in the active control group had superior overall fraction performance than students in the experimental group at the end of intervention. However, the game had a positive effect on decimal learning. We also found a positive relation between game performance and overall fraction knowledge scores at post‐test. Contribution: The study highlights the importance of game metrics as indicators of personalized assessment tools. Given the increased usage of games in learning mathematics and the equivocal results on the effectiveness of these games, our study also highlights the importance of pre‐registration and randomized controlled studies. Lay Description: What is already known about this topic: Digital game‐based learning (DGBL) is gaining popularity in mathematics teaching.DGBL shows potential for teaching difficult abstract concepts such as fractions.However, research evaluating DGBL for fractions is limited. What this paper adds: The study examines a fraction game designed by education experts and game designers.Students fraction knowledge is assessed using paper‐based test.Challenges associated with DGBL in the classroom are discussed in the paper. Implications for practice: The results will guide educators in designing effective fraction instruction in classroom.The study highlights the critical role of instructional support in DGBL for fractions.Game based metrics can be used to individualize instruction in the classroom. [ABSTRACT FROM AUTHOR]

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

Background: Perceptual, cognitive and previous clinical experience may influence a novice Videofluoroscopic Swallowing Study (VFSS) analyst's trajectory towards competency. Understanding these factors may allow trainees to be better prepared for VFSS training and may allow training to be developed to accommodate differences between trainees. Aims: This study explored a range of factors previously suggested in the literature as influencing the development of novice analysts' VFSS skills. We hypothesised that knowledge of swallow anatomy and physiology, visual perceptual skills, self‐efficacy and interest, and prior clinical exposure would all influence VFSS novice analysts' skill development. Methods & Procedures: Participants were undergraduate speech pathology students recruited from an Australian university, who had completed the required theoretical units in dysphagia. Data assessing the factors of interest were collected—the participants identified anatomical structures on a still radiographic image, completed a physiology questionnaire, completed subsections of the Developmental Test of Visual Processing—Adults, self‐reported the number of dysphagia cases they managed on placement, and self‐rated their confidence and interest. Data for 64 participants relating to the factors of interest were compared with their ability to accurately identify swallowing impairments following 15 h of VFSS analytical training, using correlation and regression analysis. Outcomes & Results: Success in VFSS analytical training was best predicted by clinical exposure to dysphagia cases and the ability to identify anatomical landmarks on still radiographic images. Conclusions & Implications: Novice analysts vary in the acquisition of beginner‐level VFSS analytical skill. Our findings suggest that speech pathologists who are new to VFSS may benefit from clinical exposure to dysphagia cases, sound foundational knowledge of anatomy relevant to swallowing and the ability to see the anatomical landmarks on still radiographic images. Further research is required to equip VFSS trainers and trainees for training, to understand differences between learners during skill development. WHAT THIS PAPER ADDS: What is already known on the subject: The existing literature suggests that no vice Video fluoroscopic Swallowing Study (VFSS) analysts training may be influenced by their personal characteristics and experience. What this study adds: This study found that student clinicians, clinical exposure to dysphagia cases and their ability to identify anatomical landmarks relevant to swallowing on still radiographic images prior to training best predicted their ability to identify swallowing impairments after training. What are the clinical implications of this work?: Given the expense of training health professionals, further research is required into the factors that successfully prepare clinicians for VFSS training, including clinical exposure, foundational knowledge of anatomy relevant to swallowing and the ability to identify the anatomical landmarks on still radiographic images. [ABSTRACT FROM AUTHOR]

Background: The language of the science curriculum is complex, even in the early grades. To communicate their scientific observations, children must produce complex syntax, particularly complement clauses (e.g., I think it will float; We noticed that it vibrates). Complex syntax is often challenging for children with developmental language disorder (DLD), and thus their learning and communication of science may be compromised. Aims: We asked whether recast therapy delivered in the context of a science curriculum led to gains in complement clause use and scientific content knowledge. To understand the efficacy of recast therapy, we compared changes in science and language knowledge in children who received treatment for complement clauses embedded in a first‐grade science curriculum to two active control conditions (vocabulary + science, phonological awareness + science). Methods & Procedures: This 2‐year single‐site three‐arm parallel randomized controlled trial was conducted in Delaware, USA. Children with DLD, not yet in first grade and with low accuracy on complement clauses, were eligible. Thirty‐three 4–7‐year‐old children participated in the summers of 2018 and 2019 (2020 was cancelled due to COVID‐19). We assigned participants to arms using 1:1:1 pseudo‐random allocation (avoiding placing siblings together). The intervention consisted of 39 small‐group sessions of recast therapy, robust vocabulary instruction or phonological awareness intervention during eight science units over 4 weeks, followed by two science units (1 week) taught without language intervention. Pre‐/post‐measures were collected 3 weeks before and after camp by unmasked assessors. Outcomes & Results: Primary outcome measures were accuracy on a 20‐item probe of complement clause production and performance on ten 10‐item unit tests (eight science + language, two science only). Complete data were available for 31 children (10 grammar, 21 active control); two others were lost to follow‐up. Both groups made similar gains on science unit tests for science + language content (pre versus post, d = 2.9, p < 0.0001; group, p = 0.24). The grammar group performed significantly better at post‐test than the active control group (d = 2.5, p = 0.049) on complement clause probes and marginally better on science‐only unit tests (d = 2.5, p = 0.051). Conclusions & Implications: Children with DLD can benefit from language intervention embedded in curricular content and learn both language and science targets taught simultaneously. Tentative findings suggest that treatment for grammar targets may improve academic outcomes. What this paper adds: What is already known on the subject: We know that recast therapy focused on morphology is effective but very time consuming. Treatment for complex syntax in young children has preliminary efficacy data available. Prior research provides mixed evidence as to children's ability to learn language targets in conjunction with other information. What this study adds: This study provides additional data supporting the efficacy of intensive complex syntax recast therapy for children ages 4–7 with Developmental Language Disorder. It also provides data that children can learn language targets and science curricular content simultaneously. What are the clinical implications of this work?: As SLPs, we have to talk about something to deliver language therapy; we should consider talking about curricular content. Recast therapy focused on syntactic frames is effective with young children. [ABSTRACT FROM AUTHOR]

Introduction: Media comparison studies examining the effectiveness of immersive virtual reality in education have yielded inconclusive findings, leaving the question of its impact on learning compared to conventional media unanswered. To address this issue, our study employs a novel approach that combines media comparison with an investigation on the influence of broader educational context. Methods: In the experiment, 262 students from two distinct types of lower secondary schools—comprehensive school and multi‐year gymnasium (a selective academic school)—participated. The students received a lesson on topography and contour line interpretation, using either an immersive virtual environment or a PowerPoint slideshow. A transfer test was carried out before, immediately after, and 1 month after the lesson to measure knowledge application. Results: The impact of the media (immersive virtual reality vs. PowerPoint slideshow) on learning outcomes was found to be minimal, with no clear advantage of one over the other in any experimental condition. In contrast, a significant influence on learning gains was observed due to school type. Multi‐year gymnasium students consistently outperformed comprehensive school students in the pre‐test and demonstrated greater learning gains, regardless of the learning media. Conclusion: The present study employs an innovative approach by integrating a comparative analysis of different media types with an investigation into the impact of learner characteristics. By including students from distinct types of schools, the study provides insights into the differential effects of immersive virtual reality in varied educational contexts. Lay Description: What is already known about this topic: Media comparison studies typically assess the effectiveness of immersive virtual reality as a learning medium in comparison to other instructional methods in education.The findings of these studies differ markedly.Numerous factors impact learning outcomes in an immersive virtual environment. What this paper adds: Recommendation that research in the field should explore not only if but also when and how IVR learning is effective.Evidence that learning achievements may not be affected by the medium used.Evidence that the type of school can significantly influence learning gains.Evidence that cognitive dispositions, such as spatial abilities, can be another factor that influence learning outcomes. Implications for practice: A technology‐centred approach alone does not allow for a proper evaluation of the learning gain potential of IVR, learner characteristics and broader educational context should also be taken into account.IVR as a learning medium may not be appropriate for all students and every educational setting.To ensure reliable evaluation of learning gains, it is necessary to align the content and format of the intervention in both learning mediums as closely as possible.Measuring learning gains not only immediately after the intervention but also with a significant time delay can contribute to a more comprehensive understanding. [ABSTRACT FROM AUTHOR]

Objective: Our study aimed to review the outcome measures/assessment instruments used and to assess their heterogeneity/homogeneity in eating disorders (EDs) randomised controlled trials. Methods: APA PsycInfo, PubMed, and Embase were searched in December 2022 to identify studies published between and inclusive of January 2012 and December 2022. Inclusion/exclusion criteria were: (1) complete articles published in peer‐reviewed scientific journals, which were: (2) randomised trials, (3) in a clinical setting (4) with human subjects, (5) with an ICD or DSM diagnosis of Anorexia Nervosa, Binge Eating Disorder, or Bulimia Nervosa. The selected papers also: (6) used one or more standardised instruments designed to measure one or more psychometric characteristics associated with ED as a primary or secondary outcome, as judged by the authors of this systematic review, and (7) were published in English or Danish. Results: Ninety one articles were included, and a total of 196 outcome measures were collected. Discussion: The diversity of outcome measures in ED trials hampers result comparability and data integration. We suggest creating a core outcome measure set using the Delphi method, including clinician and patient‐reported ED assessments, along with relevant comorbidity scales. Highlights: There is a significant heterogeneity in outcome measures and a need for standardisation.We identified a predominant focus on female participants and white populations in most randomised controlled trials (RCTs) for eating disorders (EDs), raising concerns about the generalisability of findings to diverse demographic groups.We advocate for the development of a comprehensive core outcome sets' (COS) for ED clinical trials, emphasising the minimum inclusion of a clinician‐rated clinical ED assessment, a patient self‐reported ED assessment, and scales measuring common co‐morbidities. [ABSTRACT FROM AUTHOR]

Objective: The relative merits of inpatient or day‐treatment for adults with anorexia nervosa (AN) are unknown. The DAISIES trial aimed to establish the non‐inferiority of a stepped‐care day patient treatment (DPT) approach versus inpatient treatment as usual (IP‐TAU) for improving body mass index (BMI) at 12 months in adults with AN. The trial was terminated due to poor recruitment. This paper presents outcomes and investigates the reasons behind the trial's failure. Method: Fifteen patients with AN (of 53 approached) participated and were followed‐up to 6 or 12 months. Summary statistics were calculated due to low sample size, and qualitative data concerning treatment experiences were analysed using thematic analysis. Results: At baseline, participants in both trial arms rated stepped‐care DPT as more acceptable. At 12 months, participants' BMIs had increased in both trial arms. Qualitative analysis highlighted valued and challenging aspects of care across settings. Only 6/12 sites opened for recruitment. Among patients approached, the most common reason for declining participation was their treatment preference (n = 12/38). Conclusions: No conclusions can be drawn concerning the effectiveness of IP‐TAU and stepped‐care DPT, but the latter was perceived more positively. Patient‐related, service‐related and systemic factors (COVID‐19) contributed to the trial's failure. Lessons learnt can inform future studies. Highlights: Patient‐related (e.g., treatment preferences) and service‐related (e.g., reduced service capacity) alongside wider systemic (e.g., increased emergency admissions due to COVID‐19) factors seem to have contributed to the failure of the DAISIES trial.Patients and carers identified valued aspects for both inpatient (e.g., weight gain) and day‐patient (e.g., greater link to home environment) treatment settings, but day‐patient treatment was perceived as a more holistic and collaborative approach, and thus as more positive.Although randomised controlled studies investigating intensive treatments for severe anorexia nervosa are important and necessary, alternative study designs should be explored to overcome implementation challenges. [ABSTRACT FROM AUTHOR]

Background Study: As flipped learning is a flexible pedagogical methodology to tailor students' needs and maximize the learning effects, this study integrated peer learning with MosoTeach‐supported flipped mode in an undergraduate blended EFL course. MosoTeach is a popular online learning platform in China with a variety of learning resources. Objectives: The study aimed to test the impact of MosoTeach flipped learning (MTFL) mode on undergraduate EFL students' perceived motivation, participation, feedback, and test performance. Methods: A quasi‐experimental design was carried out in Z university during the spring semester of 2020, with the experimental group (n = 34) adopting the MTFL model and a control group (n = 33) the non‐flipped mode. Results and Conclusions: The independent t‐test results showed that the experimental MTFL group outperformed the control group in post‐test scores, and a positive correlation was found in the relationship between the experimental MTFL group's post‐test scores and MosoTeach learning experience points (LEPs). Moreover, the course perception questionnaire survey indicated a higher level of students' perceived motivation, participation, and feedback in the experimental MTFL group, which corresponded to the results of the content analysis of students' responses to open‐ended questions and reflective reports. But students in both groups experienced challenges such as isolation, procrastination and technological anxiety. Lay Description: What is currently known about this topicFlipped language learning is mostly reported to be effective in improving EFL learning.Peer learning is mostly reported to be effective in improving EFL learning.MosoTeach was investigated in English learning contexts before, but without experimental design. What this paper addsMosoTeach proved as a valid online learning platform in flipped language learning, and the learning experience points (LEPs) on MosoTeach could predict students' exam performance.Students in the experimental group (MosoTeach‐supported flipped) had better exam performance and a higher level of motivation, participation and feedback.Students in both groups experienced isolation, procrastination and technological anxiety. Implications for practice:Peer discussion boards in MosoTeach provide learning support effectively for students in pre‐class learning.Group projects and peer assessment in MosoTeach integrate pre‐class peer discussion into in‐class interaction successfully.MosoTeach provides equal opportunity for every student in the large‐size Chinese English classes, thus contributing to the equity of in‐class peer interactions. [ABSTRACT FROM AUTHOR]

Background: Almost no research has been published reporting on evaluations of the effectiveness of psychological interventions for people with severe to profound intellectual disabilities and depression. This paper describes the development and initial feasibility testing of an adapted Behavioural Activation therapy (BeatIt2) for this population. Method: Phase 1 of the study examined participant recruitment and willingness to be randomised in the context of a planned Randomised Controlled Trial (RCT). Phase 2 examined the feasibility of delivering the intervention. Results: Twenty adults with a severe or profound intellectual disability and clinically significant depression were recruited to Phase 1 of the study. In Phase 2, there was 100% participant retention for those recruited to the study at 6‐month follow‐up. The BeatIt2 therapy was reported to be acceptable for participants. Conclusion: COVID disruption meant that it was not possible to complete the planned feasibility RCT. The positive findings suggest that additional evaluation of BeatIt2 is warranted. [ABSTRACT FROM AUTHOR]

Background: The development and promotion of educational games are still outpacing knowledge of these games' effects, raising calls for evidence of benefits and challenges. Studies suggest that students and teachers like games, but the payoff of the investment in terms of increased motivation and achievement remains unclear. Objectives: This study investigates the pure effect of a marketing simulation game on motivation, perceived learning and achievement, above and beyond regular student‐active instruction. Methods: We applied a randomized, controlled experiment in a marketing course in upper‐secondary schools (Nclasses = 22; Nstudents = 433) comparing a collaborative–competitive marketing simulation game with regular, case‐based, student‐active instruction on three groups of outcome measures: motivation, perceived ability, and achievement. Additionally, students and teachers provided quantitative and qualitative feedback on game experiences. Results and Conclusions: We showcase the importance of a robust study design with valid compound instruments. Moreover, investigations of the game implementation and experiences reveal insights about intervention timing, differential negative consequences by gender and need for reflection opportunities. We find no clear evidence of positive or negative effects of the game, despite students' and teachers' satisfaction. Implications: Beyond the effect evaluation, we offer recommendations to researchers and developers of educational games about scaffolding, timing and teacher competence building. Lay Description: What is already known about this topic: Some curricula contains many terms and complex knowledge links.Simulation games are a popular remedy for these challenges.Prior studies have relied on users' satisfaction with the game and unrealistic comparisons. What this paper adds: This experiment compares game usage and regular student‐active instruction.They use various measures of satisfaction, motivation, perceived learning and achievement.The game has no effect on main outcomes. Implications for practice and/or policy: Game implementation requires digitally acquainted and trained teachers.Uncritical game design and use may motivate competitive boys over collaborative girls. [ABSTRACT FROM AUTHOR]

Background: Medicines are often suboptimally managed for heart failure patients across the transition from hospital to home, potentially leading to poor patient outcomes. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme included: understanding the problems faced by patients and healthcare professionals; developing and co‐designing the Medicines at Transitions of care Intervention (MaTI); a cluster randomized controlled trial testing the effectiveness of a complex behavioural MaTI aimed at improving medicines management at the interface between hospitals discharge and community care for patients with heart failure; and a process evaluation. The MaTI included a patient‐held My Medicines Toolkit; enhanced communication between the hospital and the patient's community pharmacist and increased engagement of the community pharmacist postdischarge. This paper reports on the patients' experiences of the MaTI and its implementation from the process evaluation. Design: Twenty one‐to‐one semi‐structured patient interviews from six intervention sites were conducted between November 2018 and January 2020. Data were analysed using the Framework method, involving patients as co‐analysts. Interview data were triangulated with routine trial data, the Consolidated Framework for Implementation Research and a logic model. Results: Within the hospital setting patients engaged with the toolkit according to whether staff raised awareness of the My Medicines Toolkit's importance and the time and place of its introduction. Patients' engagement with community pharmacy depended on their awareness of the community pharmacist's role, support sources and perceptions of involvement in medicines management. The toolkit's impact on patients' medicines management at home included reassurance during gaps in care, increased knowledge of medicines, enhanced ability to monitor health and seek support and supporting sharing medicines management between formal and informal care networks. Conclusion: Many patients perceived that the MaTI offered them support in their medicines management when transitioning from hospital into the community. Importantly, it can be incorporated into and built upon patients' lived experiences of heart failure. Key to its successful implementation is the quality of engagement of healthcare professionals in introducing the intervention. Patient or Public Contribution: Patients were involved in the study design, as qualitative data co‐analysts and as co‐authors. [ABSTRACT FROM AUTHOR]

Background: Eye movement modelling examples (EMME) are demonstrations in which learners' not only see a model's (e.g., a teacher's) task performance on a computer screen (as in regular video examples) but also the model's eye movements (represented as moving coloured dots overlaid on the screen). Thereby EMME help guide learners' attention towards the relevant information and can model cognitive strategies which are otherwise unobservable for learners. Objectives: This study investigated whether EMME can help to learn deductive reasoning strategies and how the presence/absence of a teacher's verbal explanation affects learning from EMME. Methods: Secondary education students (N = 137) were randomly assigned to study video examples under one of four conditions in a 2 (EMME: yes/no) x 2 (verbal explanations: yes/no) between‐subjects design. Results and Conclusions: Results revealed only a beneficial effect of the presence of verbal explanations on performance on the practice problems, but no pretest‐to‐posttest learning gains. Implications: Seeing the teacher's eye movements does not appear to enhance learning of deductive reasoning. The presence/absence of the teacher's verbal explanation does not seem to affect learning deductive reasoning. Lay Description: What is currently known about the subject matter?: Eye movement modelling examples (EMME) are demonstrations in which learners not only see a teacher's task execution on a computer screen (as in video examples) but also the teacher's eye movements.The eye movements in EMME were visualized as moving coloured dots overlaid on the screen recording.EMME help direct attention to relevant information and enhance learning; it is not yet known if this also applies to reasoning problems.It is unknown if and how presence/absence of a teacher's verbal explanation affects learning from EMME. What our paper adds to this?: Secondary education students watched EMME or regular video examples with/without a teacher's verbal explanation.The examples demonstrated how to solve deductive reasoning problems (adapted version of the Mastermind game).Performance and learning gains were examined and revealed no differences between conditions. The implications of study findings for practitioners: Seeing the teacher's eye movements does not appear to enhance learning of deductive reasoning.The presence/absence of the teacher's verbal explanation does not seem to affect learning deductive reasoning. [ABSTRACT FROM AUTHOR]

Background: Very young children from lower socioeconomic status (SES) backgrounds often show poorer language development. Whilst there have been attempts to provide early intervention programmes, these sometimes miss the most disadvantaged groups. Aims: This report presents preliminary feasibility and effectiveness data for a novel language intervention designed for parents of toddlers in the United Kingdom. Methods and Procedures: In total, 43 UK families of 2–4‐year‐olds were recruited to the study, half of whom completed an 8‐week course (Tots Talking) focussed on parent interaction, and half of whom acted as wait‐list controls. Results and Outcomes: Results suggest that such programmes are feasible for families with 86% staying in the intervention. In addition, greater changes in underlying communication skills such as joint attention and gesture were evident compared to wait‐list controls. Conclusions and Implications: We conclude that pre‐verbal skills may be more important to measure as initial outcomes than language or vocabulary change in this population. What This Paper Adds: What is already known on the subject: Children from lower socioeconomic status (SES) backgrounds are at higher risk of communication difficulties and there is a need for community intervention programmes for very young children. What this study adds: This study suggests that such programmes can be feasible and effective, but that very early/basic communicative skills (such as joint attention) may be boosted first rather than language or vocabulary. What are the clinical implications of this work?: Children's centres and other community services could feasibly run short parent facing courses emphasising contingent communication in low SES families and other diverse groups. These may be more successful run with younger preschoolers. Joint attention may be a better focus of intervention before expecting vocabulary or language change. Community health professionals may find this information useful in referring and supporting families in need. [ABSTRACT FROM AUTHOR]

Background: Health sciences education prepares students for social‐ and healthcare by developing evidence‐based nursing, leadership and working life skills, including collaboration. Due to the changes caused by the global pandemic, health sciences education has shifted more to online and hybrid contexts, which can challenge students' competence development. Students' competence development and interaction in collaborative hybrid learning is a little researched area. Objectives: To observe and evaluate health sciences students' competence development in a collaborative hybrid learning context. Methods: This quasi‐experimental mixed‐method study was implemented by providing educational intervention. First‐year Bachelor's degree health sciences students (n = 18) of a Finnish university completed an educational intervention with synchronous online and face‐to‐face learning. Students' collaborative hybrid learning and interaction were video observed, while self‐evaluation of competence development was made with a questionnaire. Results: In the collaborative interactions, the students showed analytical thinking, problem‐ solving and communication and technology skills. Extensive knowledge of health sciences and ethics skills was not strongly visible in interaction. The students effectively used collaborative work time to perform tasks. Cognitive interaction (monitoring and evaluating learning) was observed in 85% and socio‐emotional interaction (expressions of emotions and motivation) in 53% of the data. Related to the students' learning results, the students' ability to communicate and interact with culturally different people improved after the educational intervention. Conclusion: Collaborative learning methods in hybrid learning can create opportunities for students to construct their competence in interaction. Attention should be paid to different areas of competence and the role of socio‐emotional interaction. Lay Description: What is already known about this topic: Health sciences education prepares students for social and healthcare by developing working life skills, including collaboration.Hybrid learning brings benefits but challenges the equity of students with different attention modes.Collaborative learning is widely used but has not been studied much in hybrid context.Students' competence development and interaction in collaborative hybrid learning is a little researched area. What this paper adds: The purpose was to observe and evaluate health sciences students' competence development in a collaborative hybrid learning context.Hybrid collaborative interaction encourages students to construct knowledge in health sciences.The students utilised the collaborative time appropriately.Socioemotional interactions were very visible in collaborative learning. Implications for practice: This study helps educational organisations to design hybrid model education.The design requires pedagogical and technical competence and should include collaborative methods.Attention should be paid to different areas of competence in collaborative learning.The role of socio‐emotional interaction needs more focus in hybrid learning. [ABSTRACT FROM AUTHOR]

Supportive counseling and facilitated referrals to support organizations have shown positive effects on mental health and coping with domestic and family violence. However, the reasons why and how such effects are significant remain unknown. The current paper used data from a randomized controlled trial of a psychosocial intervention implemented in Nepal among 140 abused pregnant women. The hypothesized mediating effects of self‐efficacy and social support on mental health and quality of life of abused pregnant women were tested using serial mediation analyses. Significance of parameter estimates and bias‐corrected 95% confidence intervals (CIs) for the indirect effects were generated using bootstrapping. The postintervention changes in self‐efficacy and social support were found to have significant mediating effects on the relationship between the intervention and changes in both mental health and quality of life of participants post intervention. The positive effects on outcomes were seen at follow‐up as well, though to a lesser extent. Further interventions should focus on enhancing abused women's self‐efficacy and social support to ensure their positive mental health and better lives. [ABSTRACT FROM AUTHOR]

Background: Performance goal orientations are influential motivational factors for predicting learning performance. However, a lack of attention has been paid to investigating the effects of performance goal orientations on learning performance and in‐game performance in the context of digital game‐based learning. Objectives: This study implemented a game‐based English vocabulary learning system and investigated how performance goal orientations affected learners' learning performance and in‐game performance. Methods: A total of 59 non‐English major university students participated in this study, divided into performance‐approach learners (PAPL) and performance‐avoidance learners (PAVL) based on their performance goal orientations. The English vocabulary listening test and log data were collected for conducting quantitative analyses. Results and conclusions: The results showed that the PAPL outperformed the PAVL in learning performance, whereas the two groups demonstrated similar gain scores and overall in‐game performance. Moreover, the results showed that the PAVL's learning performance was strongly associated with all aspects of in‐game performance in the learning activities. Conversely, the PAPL's learning performance was only associated with two aspects of in‐game performance in the competition activities. Implications: The findings of this study suggest that performance goal orientations play significant roles in both learning performance and in‐game performance, which could benefit the PAVL's in‐game performance, which is a substantial factor in promoting their learning performance via DGBL. Lay Description: What is already known about this topic: Digital game‐based learning (DGBL) has been widely adopted in various subject areas.DGBL is an effective learning approach for language learning.Performance goal orientations are influential motivational factors in predicting learning performance.Relevant empirical research on performance goal orientations in DGBL is scarce and inconclusive. What this paper adds: A game‐based English vocabulary learning system was developed based on the considerations of different characteristics of performance goal orientations.This study provides understandings of the impact of performance goal orientations on both learning performance and in‐game performance in DGBL.Performance‐approach learners outperformed performance‐avoidance learners, whereas the two groups demonstrated similar gain scores and overall in‐game performance.Performance‐avoidance learners' in‐game performance is a substantial factor in promoting their learning performance via DGBL. Implications for practice and/or policy: Educators should consider adopting game‐based assessment to reduce the gap between learners with different performance goal orientations.DGBL can be a potential approach to supporting different performance goal orientations, but it is particularly beneficial to learners with performance‐avoidance goals.Learners with different performance goal orientations need different types of learning activities to achieve better performance.A personalized DGBL system should be developed to accommodate the needs and preferences of learners with performance‐approach and performance‐avoidance goals. [ABSTRACT FROM AUTHOR]

Background: Process data, data generated by a user's interaction with a web‐based application, is an emerging tool in educational research. The current study explores using process data as a measure of implementation fidelity to a randomized control trial (RCT) of the Read It Again Mobile (RIA‐M) curricular supplement. Objectives: To determine the extent to which teachers implemented RIA‐M and to assess the utility of using process data in the assessment of fidelity. Methods: The RCT involved 30 pre‐kindergarten classrooms with a sample of n = 216 students. RIA‐M provides a curricular supplement which teachers may incorporate into classroom instruction and is delivered via a tablet computer. Pre and post literacy assessments are used to determine treatment effect. Process data, produced from teacher interactions with the tablet, and classroom observations are used to assess fidelity. Results and Conclusions: Our findings indicate no difference between treatment and control students in the RCT. Yet, we find that process data provides unique fidelity information concerning treatment exposure, adherence, and quality of program delivery. Specifically, process data indicated that teachers did not demonstrate the same level of fidelity that was captured in classroom observations. This finding provides some evidence for the absence of an intervention effect. Major Takeaways: The current study improves our understanding of how web‐based interventions may be assessed for implementation fidelity using process data. Further, process data offers a potentially reliable and scalable measure of fidelity for other web‐based educational interventions. Lay Description: What we know about the topic: Mobile technology‐based interventions are on the rise in many educational settings.Fidelity to educational interventions can be difficult to reliably assess.Teachers may be resistant to implementing technology in classrooms. What this paper adds: Examines a pilot study of a mobile technology‐based curricular intervention for teachers designed to improve early reading and literacy.Examines a new method for assessing fidelity of mobile technology‐based interventions.Compares the new method to traditional methods of assessing fidelity to educational interventions. Implications for practice and/or policy: The presence of technology in the classroom does not assure that the technology will be used effectively.Mobile technology‐based interventions may require additional monitoring and coaching to assure use as intended.Process data, generated in the use of technology‐based interventions, may provide a unique way to measure fidelity to the intervention. [ABSTRACT FROM AUTHOR]

Diabetic foot complications that lead to lower extremity amputations pose a significant challenge to the entire global health system. In this multicentre clinical trial, 26 patients with chronic Wagner one diabetic foot ulcers (DFUs) were treated with a unique human keratin matrix graft applied either weekly or bi‐weekly, in addition to standard of care. The hypothesis was that bi‐weekly application would be similar to weekly application. The primary endpoint was complete wound closure by 12 weeks, and secondary endpoints included healing time, percent area reduction and weekly changes in peripheral neuropathy, pain and quality of life. In the intent‐to‐treat population, 77% (10/13) of DFUs treated with bi‐weekly application healed compared with 69% (9/13) treated with weekly application. The mean time to heal within 12 weeks in the bi‐weekly group was 61 days and in the weekly group was 54 days. The mean percent area reduction at 12 weeks was 94.7% in the bi‐weekly group compared with 84.8% in the weekly group. The number of grafts used in the bi‐weekly group was 3.9 compared with 6.2 in the weekly group. The results of this trial confirm our hypothesis that whether bi‐weekly or weekly application of the unique keratin matrix graft is used to treat nonhealing indolent DFUs, there is a high rate of complete healing. Based on these results, future studies should be conducted that further investigate the use of this novel human keratin matrix graft for the treatment of chronic DFUs. [ABSTRACT FROM AUTHOR]

To investigate the effects of 8‐week hiking bench training on cardiorespiratory and muscular responses of highly trained sailors during hiking emulation. Twenty‐four sailors were assigned into two groups: the hiking bench training group (HTG, n = 12) and the control group (CG, n = 12). Both groups maintained their regular training with the HTG performed two additional hiking bench training sessions per week for 8 weeks, while the CG performed an equivalent duration of on‐water sailing training. Physiological responses were assessed by performing four successive 3‐min hiking bouts on a sailing emulation ergometer before and after the 8‐week training period. Comparing the pretest, both groups exhibited a significant decrease (p < 0.05) in the percentage of maximal oxygen uptake (%VO2max) and maximal heart rate (%HRmax); the HTG experienced a greater decrease in %VO2max in bouts 2 and 3. The root mean square (RMS) of rectus femoris (RF), vastus lateralis (VL), rectus abdominis (RA), and external oblique decreased significantly (p < 0.05), whereas the mean power frequency (MPF) of RF, VL, and RA exhibited an increasing trend. The RMS of RF and RA in HTG were lower than those in CG in the initial three bouts; VL and EA in HTG were lower than those in CG in bouts 1 and 2 (p < 0.05). The MPF of RA in HTG was significantly increased in bouts 2, 3, and 4 (p < 0.05). Eight‐week hiking bench training could improve hiking economy and the activation of lower limb and trunk muscles delaying the onset of fatigue in sailors. Highlights: Hiking is the most physically demanding task in dinghy sailing, eliciting highly specific cardiorespiratory, and muscular responses. Highly trained sailors attempt to improve the physiological response and performance of hiking through hiking bench training.Hiking bench training involves a series of movement exercises performed by sailors on sailing emulation ergometer that are tailored specific profiles with the objective of optimizing sailing performance.Hiking bench training can effectively enhance the economy of hiking among highly trained sailors, improve the activation of lower limb and trunk muscles, and delay the onset of fatigue in hiking. Hiking bench training can be used as an effective means of enhancing hiking performance for highly trained sailors. [ABSTRACT FROM AUTHOR]

Cardiovascular (CV) disease accounts for one third of deaths in females, with hypertension (HTN) and type 2 diabetes mellitus (T2DM) risk factors for its development. Global longitudinal strain (GLS) is a strong prognostic indicator for future CV dysfunction and can be impaired in women with HTN and T2DM. This study aimed to determine if exercise impacts GLS in women with HTN or T2DM. A randomized crossover trial was conducted with 15 women (aged 64.1 ± 4.7) diagnosed with HTN (n = 12) or T2DM (n = 3). Participants completed an 8‐week exercise and 8‐week non‐exercising control period, separated by a 21.6 ± 14.2‐week washout period. Resting echocardiography and exercise testing were performed pre and post each arm to measure GLS and aerobic fitness (VO2peak). GLS (%) improved significantly following exercise (−16.8 ± 1.5 to −18.4 ± 1.8; p ≤ 0.001, d = 0.98), but not control (−17.2 ± 2.0 to −16.9 ± 1.4; p = 0.585, d = −0.14). Similarly, VO2peak (mL/kg/min) increased following exercise (18.0 ± 2.1 to 19.2 ± 2.6; p ≤ 0.001, d = 0.53), but not control (17.5 ± 2.7–17.2 ± 2.7; p = 0.269, d = −0.12). There were significant between‐group differences for GLS (p ≤ 0.001, d = 1.02) and VO2peak (p = 0.011, d = 0.63). Aerobic exercise positively impacts GLS and VO2peak in women with HTN and T2DM. GLS may inform exercise professionals regarding the early effectiveness of an aerobic exercise intervention and infer a reduction in CV disease risk. Highlights: The impact of aerobic exercise on global longitudinal strain (GLS), and other measures of cardiovascular (CV) function, was explored in women with hypertension and type 2 diabetes.Eight weeks of aerobic exercise significantly improved GLS (very large effect; d = 1.02) and aerobic capacity (moderate effect; d = 0.63) compared to control.Improvements observed in GLS and aerobic capacity were clinically meaningful. Significant reductions in systolic and diastolic blood pressure were also observed following exercise, but not control.GLS can measure the effectiveness of aerobic exercise on myocardial function in women at risk of developing CV disease. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to evaluate the use of after‐visit instructions (AVIs) in an academic rheumatology clinic and assess the impact of standardized AVIs (sAVIs) and teach‐back (TB) on comprehension of health information. Methods: A retrospective review of adult patients seen between October 1 and 8, 2021, at the rheumatology clinic collected data on patient demographics, clinical features, and the presence, content, and readability of AVIs. During a subsequent prospective proof‐of‐concept study, routinely scheduled patients seen at the rheumatology clinic were randomized into three groups: control (received standard of care), received sAVIs only, and received sAVIs plus TB. Patients completed a health literacy questionnaire, satisfaction survey, and a one‐ to two‐week postvisit telephone survey to assess AVI comprehension. Results: Out of 316 retrospective patient visits, 82 (25.9%) received AVIs. Among 210 of 316 patients (66.5%) with management changes, 76 (36.1%) received AVI, with 74.2% of the instructions considered concordant with the provider's note. Use of AVIs was higher with management changes, new patient visits, and medical trainee/teaching clinics. AVIs were written at a median 6.8 grade level. A total of 75 patients completed the prospective study: 31 (41.3%) were in the control group, 19 (25.3%) were in the group that received sAVIs only, and 25 (33.3%) were in the group that received AVIs with TB. There were no differences in overall postvisit survey comprehension/retention scores among the three patient groups evaluated. Conclusion: Although a lack of AVI use was identified, implementation of sAVIs did not appear to impact patient retention or comprehension of discharge health information. [ABSTRACT FROM AUTHOR]

This was a non‐blinded, single‐centre, randomized, controlled clinical trial that compared the effectiveness of direct observation of procedural skills (DOPSs)with traditional assessment methods in pressure injury (PI) care skills. The study population included 82 nursing professionals randomly assigned to the study group (n = 41) and the control group (n = 41). Both groups of nurses underwent a 6‐month training in PI care skills and were subsequently evaluated. The main outcome variables were the PI skill operation scores and theoretical scores. Secondary outcome variables included satisfaction and critical thinking abilities. Independent sample t‐tests and chi‐square tests were used to assess differences between the two groups of nurses. The results showed no statistically significant difference in PI skill operation scores between the two groups of nurses (p > 0.05). When comparing the PI theoretical scores, the study group scored higher than the control group, and this difference was statistically significant (p < 0.05). In terms of satisfaction assessment, the study group and the control group showed differences in improving self‐directed learning, enhancing communication skills with patients, improving learning outcomes and increasing flexibility in clinical application (p < 0.05). When comparing critical thinking abilities between the two groups of nurses, there was no statistically significant difference at the beginning of the training, but after 3 months following the training, there was a statistically significant difference between the two groups (p < 0.01).The results indicated that the DOPS was effective in improving PI theoretical scores, increasing nurse satisfaction with the training and enhancing critical thinking abilities among nurses. [ABSTRACT FROM AUTHOR]

Backgroud: Discharge planning from the hospital of frail older patients is an important step to avoid inappropriate long‐stay hospitalizations and to prevent the risks related to the prolonged hospitalization. In this frame, we developed an experimental trial—'PRO‐HOME', a multicomponent programme of interventions for multimorbid and polytreated hospitalized older patients. Aim: The main aim of the study was to develop a protected discharge facility using a mini apartment equipped with advanced architectural and technological components to reduce the length of hospital stay of older participants (aged 65+ years old) admitted to the hospital for an acute event, deemed stable and dischargeable. Materials and Methods: This is a pilot randomized controlled study, comparing 30 hospitalized participants included in a multidimensional, transitional care programme based on information and communication technologies to 30 patients in standard usual care until hospital discharge. Results: We presented the study design of the PRO‐HOME programme, including architectural and technological components, the enrolment procedures, the components of the intervention that is physical activity, cognitive training and life‐style education and the evaluation method of the intervention based on the Comprehensive Geriatric Assessment to explore the changes in the individual domains that are target of the multicomponent intervention. Conclusions: The final results will suggest whether the PRO‐HOME programme represents a useful and feasible intervention to reduce the length of hospital stay of multimorbid and polytreated hospitalized older patients and improve their physical and cognitive performances and overall quality of life. Patient or Public Contribution: Due to the characteristics of the population of interest of the PRO‐HOME study, we involved in the study design and programme of the activities the participants enrolled in a previous smart home‐based project named MoDiPro carried‐out during a 3‐year period. The elderly participants from the local population involved were asked, by means of focus groups, for feedback on their experience in MoDiPro, and their suggestions were integrated into the design phase of the current PRO‐HOME project. The focus groups included open group interviews with a qualitative collection of the patients' feedback so that the participants could interact with each other. [ABSTRACT FROM AUTHOR]

Resistance exercise training is effective to counteract the adverse effects of androgen deprivation therapy (ADT) on body composition, muscle mass and leg strength in prostate cancer patients (PCa). However, it is unknown whether these effects can be autonomously maintained after cessation of the supervised program. Sixty‐eight PCa patients on ADT were included. The exercise intervention group (EX, n = 37) performed 20 weeks of supervised resistance exercise training. Thereafter, patients were advised to autonomously continue exercise training. The control group (CON, n = 31) only received usual care. Outcome measures were compared between baseline and after 1 year. Changes during the intervention (baseline vs. 20 weeks) and follow‐up period (20 weeks vs. 1 year) were descriptively explored. In EX, 83% reported to have continued exercise training themselves. After 1 year, fat mass gains were attenuated in EX compared to CON (1.2 ± 2.6 and 2.8 ± 1.9 kg, respectively; time × treatment effect p = 0.032). The fat percentage increased, and lean mass and quadriceps muscle cross‐sectional area decreased over time, with no differences between groups (overall 1.6 ± 2.1%, −0.7 ± 2.3 kg and −2.2 ± 2.9 cm2, respectively; time effects, all p < 0.05). For muscle strength, an increase of ∼5% in EX was observed, significantly different from the ∼10% decrease in CON (p < 0.001). Subsequent analyses showed that the initial exercise training‐obtained gains in lean mass, muscle mass and strength in EX compared to CON, declined during the follow‐up period. In conclusion, PCa patients on ADT are not capable to autonomously maintain the exercise‐obtained gains of a 20‐week supervised training program over a subsequent 1‐year period. Highlights: ADT for prostate cancer results in many side effects, including muscle mass lossA supervised resistance exercise training program can counteract many side effectsAfter cessation of the supervised program, exercise benefits are not effectively preservedMore focus on sustainability of exercise programs during ADT is required [ABSTRACT FROM AUTHOR]

A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty‐five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty‐nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers. [ABSTRACT FROM AUTHOR]

Purpose: Our study explored the mediating effect of sleep‐related variables on older adolescents' mental health in the context of a school‐based physical activity intervention. Methods: We evaluated the Burn 2 Learn (B2L) intervention using a cluster randomized controlled trial, which included two cohorts. Participants for this sub‐study were from the second cohort, which included 292 older adolescents (16.0 ± 0.5 years) from 10 secondary schools in New South Wales, Australia. Teachers at intervention schools delivered two high‐intensity activity breaks (approximately 10 mins) per week to students during academic lessons. Participants completed measures of mental health (i.e., perceived stress and internalizing problems) and hypothesized mediators (i.e., sleep duration, sleep latency, awakenings, and daytime sleepiness) at baseline (February–April 2019) and post‐intervention (August–September 2019). Single mediation analyses were conducted to explore the potential mediating effects of sleep variables on mental health outcomes using a product‐of‐coefficient test. Results: We observed a small statistically significant effect for perceived stress (β = −0.11, SE = 0.034, p = 0.002), but not for internalizing problems (β = 0.02, SE = 0.051, p = 0.760). There were no significant intervention effects for sleep‐related variables. Several sleep‐related variables were associated with mental health outcomes but no mediated effects were found. Conclusion: The B2L intervention had a small beneficial effect on perceived stress, however our mediation analyses suggest this was not explained by changes in sleep‐related variables. Markers of sleep were associated with mental health constructs, highlighting the importance of sleep for good psychological health. However, in the context of a physical activity intervention, effects on mental health may be driven by other behavioral, neurobiological, or psychosocial mechanisms. [ABSTRACT FROM AUTHOR]

Background: The primary prevention of periodontitis is controlling gingivitis daily. The study objective was to compare the efficacy of a pulsating water flosser to a pulsating water flosser infused with air microbubbles on clinical signs of inflammation and plaque. Methods: One hundred and five participants were enrolled in this single‐blind, single‐centre, parallel, 4‐week, IRB/IEC‐approved clinical trial. Participants were randomly assigned to one of three groups: water flosser (WF) plus manual toothbrush, water flosser infused with microbubbles of air (MBWF) plus manual toothbrush, or dental floss (DF) plus manual toothbrush. Bleeding on probing (BOP), Modified Gingival Index (MGI) and Rustogi Modification Navy Plaque Index (RMNPI) scores were recorded at baseline, 2 and 4 weeks. Results: All participants completed the study (n = 105). All groups showed a statistically significant reduction for BOP, MGI and RMNPI at 4 weeks (p < 0.05, except DF marginal RMNPI). The WF group showed a statistically significant greater reduction in whole mouth BOP (0.41) compared to MBWF (0.32) and DF (0.19). This was also true for MGI (0.37, 0.30 and 0.20, respectively) and RMNPI (0.13, 0.11 and 0.06, respectively; p < 0.05 for all comparisons). No adverse events were reported. Conclusion: This study demonstrates that a manual toothbrush and water flosser, with or without microbubbles, is an effective oral care regimen for controlling gingivitis over 4 weeks. [ABSTRACT FROM AUTHOR]

To evaluate the status of a 7‐month phase 3 study conducted to test the effect of intramuscular injections of VM202 (ENGENSIS), a plasmid DNA encoding human hepatocyte growth factor, into the calf muscles of chronic nonhealing diabetic foot ulcers with concomitant peripheral artery disease. The phase 3 study, originally aimed to recruit 300 subjects, was discontinued because of slow patient recruitment. An unprespecified interim analysis was performed for the 44 subjects enrolled to assess the status and determine the future direction. Statistical analyses were carried out for the Intent‐to‐Treat (ITT) population and separately for subjects with neuroischemic ulcers, using a t‐test and Fisher's exact test. A logistic regression analysis was also conducted. VM202 was safe and potentially should have benefits. In the ITT population (N = 44), there was a positive trend toward closure in the VM202 group from 3 to 6 months but with no statistical significance. Levels of ulcer volume or area were found to be highly skewed between the placebo and VM202 groups. Forty subjects, excluding four outliers in both arms, showed significant wound‐closing effects at month 6 (P =.0457). In 23 patients with neuroischemic ulcers, the percentage of subjects reaching complete ulcer closure was significantly higher in the VM202 group at months 3, 4, and 5 (P =.0391,.0391, and.0361). When two outliers were excluded, a significant difference was evident in months 3, 4, 5, and 6 (P =.03 for all points). A potentially clinically meaningful 0.15 increase in Ankle‐Brachial Index was observed in the VM202 group at day 210 in the ITT population (P =.0776). Intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in the treatment of chronic neuroischemic diabetic foot ulcers (DFUs). Given the safety profile and potential healing effects, continuing a larger DFU study is warranted with modifications of the current protocol and expansion of enrolling sites. [ABSTRACT FROM AUTHOR]

Objective: This Phase II, placebo‐controlled, double‐blind study investigated the efficacy, safety, and tolerability of nivasorexant in the treatment of adults with moderate to severe binge‐eating disorder (BED). Methods: Adults meeting the DSM‐5 BED criteria were randomized 1:1 to placebo or nivasorexant (100 mg b.i.d.). The primary endpoint was the change from baseline to Week 12 in the number of binge eating (BE) days per week. Exploratory efficacy endpoints included cessation of BE in the last 4 weeks of treatment; and change from baseline to Week 12 in the number of BE episodes/week, the clinician global impression (CGI) of change, the Yale‐Brown Obsessive‐Compulsive Scale modified for BE, and the Hamilton rating scale for depression (HAMD‐17). Key safety outcomes included treatment‐emergent adverse events (TEAEs) and adverse events of special interest (i.e., somnolence and fatigue). Results: Sixty‐eight participants were randomized to each treatment arm. The change from baseline to Week 12 in the number of BE days/week was the same for placebo (least squares mean [LSM]: −2.93) and nivasorexant (LSM: −2.93), with no difference between the treatment groups (LSM difference =.000 [95% confidence interval (CI): −.69,.69], p =.9992). Furthermore, no differences between treatment groups were observed in the exploratory efficacy endpoints. Nivasorexant was well tolerated; the overall incidence of TEAEs was balanced between treatment groups, and the frequency of somnolence and fatigue in the nivasorexant group were similar to placebo. Discussion: In this proof‐of‐concept study, 100 mg b.i.d. nivasorexant did not improve BE in adults with moderate to severe BED. Public Significance: The results of this Phase II study indicate that nivasorexant was well tolerated in adults with BED, but did not improve binge eating behavior over placebo. Further research is needed to improve our understanding of the role of the orexin‐1 receptor in BED. [ABSTRACT FROM AUTHOR]

Background: Driving while intoxicated (DWI) is a serious public health problem. However, treatment for DWI arrestees is not readily available. This study examines the effectiveness of a contingency management (CM) procedure using transdermal alcohol concentration (TAC) monitoring to reduce drinking among DWI arrestees. Method: The study participants were 216 DWI arrestees under pretrial and included both Mandated participants undergoing court‐ordered TAC monitoring and Non‐Mandated participants wearing a study‐provided TAC monitor. Participants were randomly assigned to either a CM (Mandated = 35; Non‐Mandated = 74) or a Control condition (Mandated = 37; Non‐Mandated = 70) and completed the 8‐week intervention. CM participants received $50/week for not exceeding a TAC of 0.02 g/dL during the previous week. Payments to Controls were yoked to the CM group. Results: Among Non‐Mandated participants, the probability of meeting the contingency was higher and remained stable (about 65%) over time in the CM group, whereas the probability was lower and declined in the Control group, widening the gaps in the probability between the study conditions (16.7%–24.1% greater in the CM group from visit 4 to 8, all p < 0.05). Among Mandated participants, the probability was not significantly different between conditions (p = 0.06–0.95). Furthermore, among Non‐Mandated participants, the percentage of heavy drinking days remained low (9.16%–11.37%) in the CM group, whereas it was greater and increased over time (17.43%–26.59%) in the Control group. In Mandated participants, no significant differences in percent heavy drinking days were observed between conditions (p = 0.07–0.10). Conclusion: We found that contingency effects on alcohol use are more pronounced among frequent and heavy alcohol users, i.e., Non‐Mandated DWI arrestees. However, for individuals whose drinking was already suppressed by existing contingencies (i.e., court‐mandated TAC monitoring), our CM procedure did not produce additional reductions in drinking. [ABSTRACT FROM AUTHOR]

This article updates a 2017 review on the effectiveness of digital interventions for reducing alcohol use in the general population. An updated systematic search of the MEDLINE database was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses criteria to identify randomized controlled trials (RCTs) published from January 2017 to June 2022 that evaluated the effectiveness of digital interventions compared with no interventions, minimal interventions, and face‐to‐face interventions aimed at reducing alcohol use in the general population and, that also reported changes in alcohol use (quantity, frequency, quantity per drinking day, heavy episodic drinking (HED), or alcohol use disorders identification test (AUDIT) scores). A secondary analysis was performed that analyzed data from RCTs conducted in students. The review was not preregistered. The search produced 2224 articles. A total of 80 studies were included in the review, 35 of which were published after the last systematic review. A total of 66, 20, 18, 26, and 9 studies assessed the impact of digital interventions on alcohol quantity, frequency, quantity per drinking day, HED, and AUDIT scores, respectively. Individuals randomized to the digital interventions drank 4.12 (95% confidence interval (CI): 2.88, 5.36) fewer grams of alcohol per day, had 0.17 (95% CI 0.06, 0.29) fewer drinking days per week, drank approximately 3.89 (95% CI: 0.40, 7.38) fewer grams of alcohol per drinking day, had 1.11 (95% CI: 0.32, 1.91) fewer HED occasions per month, and had an AUDIT score 3.04 points lower (95% CI: 2.23, 3.85) than individuals randomized to the control condition. Significant reductions in alcohol quantity, frequency, and HED, but not quantity per drinking day, were observed among students. Digital interventions show potential for reducing alcohol use in general populations and could be used widely at the population level to reduce alcohol‐attributable harms. [ABSTRACT FROM AUTHOR]

Background: Primary care settings like federally qualified health centers (FQHC) are optimal locations to identify individuals with substance use disorders (SUD) and link them to SUD treatment, yet successful linkage has proven difficult. Recovery management checkups for primary care (RMC‐PC) is a promising method for increasing linkage to care, engagement in treatment, and reducing substance use. Methods: Participants (n = 266) who received screening, brief intervention, and referral to treatment (SBIRT) at four FQHC sites and needed SUD treatment were randomized to receive SBIRT only or SBIRT+RMC‐PC. All participants received SBIRT prior to randomization as part of usual care while those in the experimental group also received quarterly checkups. All participants completed research interviews at enrollment and 3, 6, 9, and 12 months post‐enrollment. The primary outcome was whether participants received any days of SUD treatment. Key secondary outcomes were days of SUD treatment (total and by SUD level of care), days of alcohol or drug abstinence, and a reduction in days of specific substance use, all based on self‐report. Results: Relative to participants receiving SBIRT only, participants assigned to SBIRT+RMC‐PC were significantly more likely to have received any SUD treatment over 12 months (adjusted odds ratio [AOR] = 3.85) and more days of SUD treatment over 12 months (Cohen's effect size d = +0.41). The SBIRT+RMC‐PC group also reported significantly more days of abstinence over 12 months (d = +0.30), fewer days of alcohol use (d = −0.20) and cannabis use (d = −0.20), and lower combined substance use frequency (d = −0.25). Days of treatment were found to positively mediate the direct effect of SBIRT+RMC‐PC on days of abstinence. Conclusion: This study provides further evidence of the effectiveness of the "referral to treatment" component of SBIRT when combined with RMC for patients in primary care settings, including those with drug use problems. Moreover, results demonstrate the value of repeated checkups on longer‐term treatment and substance use outcomes. [ABSTRACT FROM AUTHOR]

Diabetic foot ulcer (DFU) is a major cause of morbidity, non‐traumatic lower limb amputation in diabetic patients and a high‐cost burden on the healthcare system. New therapeutic products are increasingly tested. Platelet‐rich plasma (PRP) and human platelet lysate (hPL) are reported to be useful. This trial was conducted to test whether the healing effect of hPL in chronic DFU was due to plasma or platelet lysates in a prospective double‐blind design. Autologous PRP was obtained from citrated blood, lysed, and used as drug 1 (active product). The platelet‐poor plasma (PPP) was used as a drug 2 (placebo). Ten patients were enrolled in arm 1 and 9 in arm 2. The drugs were injected perilesionally every 2 weeks for a total of sixinjections. Adverse events were recorded until Week 14. The DFUs were scored per the Texas and Wegner systems. No patient showed any major adverse events. Some reported local pain post‐injection. Wound healing was achieved in the hPL group in 9/10 of patients at a mean of 35.1 days. In the PPP group, no patient had healed by Day 84. The difference was statistically significant at P < 0.00001. We conclude that autologous hPL is safe and highly effective in healing chronic DFU and is superior to autologous PPP. [ABSTRACT FROM AUTHOR]

The purpose of this open‐label, randomized, controlled, in‐clinic, 5‐parallel‐group study was to assess biomarkers of exposure (BoE) to select harmful and potentially harmful constituents in adults who smoke (N = 144) switching to oral tobacco products (on!® mint nicotine pouches; test products) compared to continuing smoking cigarettes (CS) and completely quitting all tobacco products (NT). Changes in 20 BoE to select harmful and potentially harmful constituents, including 4‐(methylnitrosamino)‐1‐(3‐pyridyl)‐1‐butanol (NNAL), were evaluated. Adult smokers smoked their usual brand of cigarettes for 2 days (baseline assessments) and then were randomly assigned to ad libitum use of 2, 4, or 8 mg test products, CS, or NT for 7 days. Analysis of covariance was used to assess the Day 7 BoE levels between each group using test products, CS, and NT. The creatinine‐adjusted total urinary NNAL and other 18 of 19 BoE levels (except nicotine equivalents [NEs]) were significantly lower (P <.05) on Day 7, among all test product groups compared to CS. Geometric least‐square means were reduced for all biomarkers of exposure, except NEs, in test product groups by approximately 42%–96% compared to the CS group, and reductions were comparable to the NT group. The geometric least‐square means for urinary NE between the test product and the CS groups, although not significantly different, the Day 7 mean change relative to the CS group were 49.9%, 65.8%, and 101% for the 2, 4, and 8 mg test product groups, respectively. The substantial reduction in harmful and potentially harmful constituent exposure suggests complete switching from cigarettes to test products may present a harm reduction opportunity for adults who smoke. [ABSTRACT FROM AUTHOR]

Objectives: Transfusion of a high ratio of plasma to packed red blood cells (PRBCs), to treat or prevent acute traumatic coagulopathy, has been associated with survival after major trauma. However, the effect of prehospital plasma on patient outcomes has been inconsistent. The aim of this pilot trial was to assess the feasibility of transfusing freeze‐dried plasma with red blood cells (RBCs) using a randomized controlled design in an Australian aeromedical prehospital setting. Methods: Patients attended by helicopter emergency medical service (HEMS) paramedics with suspected critical bleeding after trauma managed with prehospital RBCs were randomized to receive 2 units of freeze‐dried plasma (Lyoplas N‐w) or standard care (no plasma). The primary outcome was the proportion of eligible patients enrolled and provided the intervention. Secondary outcomes included preliminary data on effectiveness, including mortality censored at 24 h and at hospital discharge, and adverse events. Results: During the study period of June 1 to October 31, 2022, there were 25 eligible patients, of whom 20 (80%) were enrolled in the trial and 19 (76%) received the allocated intervention. Median time from randomization to hospital arrival was 92.5 min (IQR 68–101.5 min). Mortality may have been lower in the freeze‐dried plasma group at 24 h (RR 0.24, 95% CI 0.03–1.73) and at hospital discharge (RR 0.73, 95% CI 0.24–2.27). No serious adverse events related to the trial interventions were reported. Conclusions: This first reported experience of freeze‐dried plasma use in Australia suggests prehospital administration is feasible. Given longer prehospital times typically associated with HEMS attendance, there is potential clinical benefit from this intervention and rationale for a definitive trial. [ABSTRACT FROM AUTHOR]

Objectives: To test the effect of locally delivered doxycycline (DOX) administered 2 weeks prior to minimally invasive periodontal regeneration in terms of presurgical inflammatory status and cytokine expression profile in the gingival crevicular fluid (GCF). Secondary aim was to assess the early wound healing index (EHI) at 2 weeks after surgery. Background: It is hypothesized that healing after periodontal regeneration is dependent on preoperative soft tissue condition, and that local antibiotics may improve the site‐specific inflammatory status at short time. Methods: Sites associated with periodontal intrabony defects requiring regenerative surgery and showing bleeding on probing (BoP) were included. At T0, experimental sites were randomly treated with subgingival instrumentation with or without topic DOX application. After 2 weeks (T1), defects were approached by means of minimally invasive surgical technique. GCF was sampled at both T0 and T1 for inflammatory biomarker analysis. Two weeks after surgery, the EHI was evaluated (T2). Results: Forty‐four patients were included. At T1, the number of BoP+ sites was statistically significantly less in the test group (27.3% vs. 72.7%; p <.01). The total amount of interleukin (IL)‐1β (p <.001), matrix‐metalloproteinases (MMP)‐8 (p <.001), and MMP‐9 (p =.010) in the GCF significantly decreased in the test group at T1, with relevant differences compared to controls. At T2, the EHI had an average value of 1.45 ± 0.86 in the test group while in the control, it was 2.31 ± 1.43 (p =.027). A statistically significantly positive correlation was observed between the amount of IL‐1β and MMP‐9 and EHI scores. Conclusions: Within the limitations of this study, sites treated with DOX showed improved clinical and molecular inflammatory parameters before surgery, as well as soft tissue healing 2 weeks after surgery. [ABSTRACT FROM AUTHOR]

Background: No previous studies have reported predictors and moderators of outcome of psychological therapies for depression experienced by adults with intellectual disabilities (IDs). We investigated baseline variables as outcome predictors and moderators based on a randomised controlled trial where behavioural activation was compared with guided self‐help. Methods: This study was an exploratory secondary data analysis of data collected during a randomised clinical trial. Participants (n = 161) were randomised to behavioural activation or guided self‐help and followed up for 12 months. Pre‐treatment variables were included if they have previously been shown to be associated with an increased risk of having depression in adults with IDs or have been reported as a potential predictor or moderator of outcome of treatment for depression with psychological therapies. The primary outcome measure, the Glasgow Depression Scale for Adults with Learning Disabilities (GDS‐LD), was used as the dependant variable in mixed effects regression analyses testing for predictors and moderators of outcome, with baseline GDS‐LD, treatment group, study centre and antidepressant use as fixed effects, and therapist as a random effect. Results: Higher baseline anxiety (mean difference in outcome associated with a 1 point increase in anxiety 0.164, 95% confidence interval [CI] 0.031, 0.297; P = 0.016), lower performance intelligence quotient (IQ) (mean difference in outcome associated with a 1 point increase in IQ 0.145, 95% CI 0.009, 0.280; P = 0.037) and hearing impairment (mean difference 3.449, 95% CI 0.466, 6.432; P = 0.024) were predictors of poorer outcomes, whilst greater severity of depressive symptoms at baseline (mean difference in outcome associated with 1 point increase in depression −0.160, 95% CI −0.806, −0.414; P < 0.001), higher expectation of change (mean difference in outcome associated with a 1 point increase in expectation of change −1.013, 95% CI −1.711, −0.314; p 0.005) and greater percentage of therapy sessions attended (mean difference in outcome with 1 point increase in percentage of sessions attended −0.058, 95% CI −0.099, −0.016; P = 0.007) were predictors of more positive outcomes for treatment after adjusting for randomised group allocation. The final model included severity of depressive and anxiety symptoms, lower WASI performance IQ subscale, hearing impairment, higher expectation of change and percentage of therapy sessions attended and explained 35.3% of the variance in the total GDS‐LD score at 12 months (R2 = 0.353, F4, 128 = 17.24, P < 0.001). There is no evidence that baseline variables had a moderating effect on outcome for treatment with behavioural activation or guided self‐help. Conclusions: Our results suggest that baseline variables may be useful predictors of outcomes of psychological therapies for adults with IDs. Further research is required to examine the value of these potential predictors. However, our findings suggest that therapists consider how baseline variables may enable them to tailor their therapeutic approach when using psychological therapies to treat depression experienced by adults with IDs. [ABSTRACT FROM AUTHOR]

Background: The objective of this study was to assess the preliminary efficacy and safety of conservative management compared with systematic suture in isolated vaginal or first‐degree perineal tears after birth. Methods: We conducted a preliminary efficacy, open‐label, randomized, controlled, and prospective trial. This study implemented Simon's 2‐step plan (interim analysis and final analysis) to test the success rate of the digital compression strategy group. Primiparous women aged ≥18 years with isolated vaginal or first‐degree perineal tears after spontaneous vaginal birth of a cephalic presenting term (≥37 weeks) neonate were randomly allocated to the conservative management (CM) group (digital compression if bleeding followed by suture if persistent bleeding) or a systematic suture (SS) group. The primary outcome was the success of the intervention 10 days after delivery, defined by pain as evaluated using a visual analog scale < 3, satisfactory healing defined by a REEDA score ≤ 2, and no bleeding or infection. Sexual well‐being was assessed at 2 and 6 months postpartum. Results: Among 861/2209 eligible women, 143 consenting women with a superficial perineal tear were randomized: 72 in the systematic suture group and 71 in the conservative management group. Success rate was 87.8% (90% CI [70.5‐93.54]) (42/55) in the systematic suture group vs 90% (90% CI [78.3‐93.8]) (53/61) in the conservative management group. The REEDA score was significantly higher in the systematic suture group (1.4 vs 0.9; P = 0.036). Perineal pain was significantly higher at day 1 in the systematic suture group (2.38 vs 1.69; P = 0.034). For the Female Sexual Functional Index score, no significant difference was found between the two groups at inclusion or at 2 and 6 months postpartum. Conclusions: Conservative management of superficial perineal tears shows an efficacy rate ≥90%. Women in the conservative management group had less pain at the 1st day follow‐up and lower REEDA scores at the 10th day follow‐up. [ABSTRACT FROM AUTHOR]

Background: We assessed the change in obstetric management after implementation of a quality improvement intervention, the Nepal Perinatal Quality Improvement Package (NePeriQIP). Methods: The Nepal Perinatal Quality Improvement Package was a stepped‐wedge cluster‐randomized controlled trial conducted in 12 public hospitals in Nepal between April 2017 and October 2018. In this study, three hospitals allocated at different time points to the intervention were selected for a nested before–after analysis. We used bivariate and multivariate analyses to compare obstetric management in the control vs intervention group. Results: There were 25 977 deliveries in the three hospitals during the study period: 10 207 (39%) in the control and 15 770 (61%) in the intervention group. After adjusting for maternal age, ethnicity, education, gestational age, stage of labor at admission, complications during labor, and birthweight, the intervention group had a higher proportion of fetal heart rate monitoring performed as per protocol (adjusted odds ratio [aOR] 1.19, 95% confidence interval [CI] 1.12–1.27), shorter time intervals between each fetal heart rate monitoring (aOR 2.09, 95% CI 1.96–2.23), a higher likelihood of abnormal fetal heart rate being detected (aOR 1.53, 95% CI 1.25–1.68), progress of labor more often being recorded immediately after per vaginal examination (aOR 2.73, 95% CI 2.55–2.93), and partograph filled as per standards (aOR 3.18, 95% CI 2.98–3.50). The cesarean birth rate was 2.5% in the control group and 8.2% in the intervention group (aOR 3.12, 95% CI 2.64–3.68). Conclusions: The NePeriQIP intervention has potential to improve obstetric care, especially intrapartum fetal surveillance, in similar low‐resource settings. [ABSTRACT FROM AUTHOR]

Purpose: The research aimed to examine the effect of a lifestyle intervention program using mobile application versus booklet for adults with metabolic syndrome in Hong Kong. The outcomes comprised body weight (primary outcome), exercise amount, improvement of cardiometabolic risk factors, cardiovascular endurance, perceived stress scale, and exercise self‐efficacy. Design A three‐arm randomized controlled trial namely App group, Booklet group, and control group was adopted. Methods: Two hundred sixty‐four adults with metabolic syndrome were recruited from community centers from 2019 to December 2021. Inclusion criteria are those adults with metabolic syndrome, able to use a smart phone. All participants received a 30‐min health talk. App group additionally received a mobile application, while Booklet group received a booklet, and the control group received a placebo booklet. Data were collected at baseline, Weeks 4, 12, and 24. SPSS and generalized estimating equations (GEE) model were employed for data analysis. Findings Attrition rates were minimal, ranged from 2.65% to 6.44%. Both app and booklet group showed significant improvement in outcomes (exercise amount, waist circumference) when compared to control group. However, statistically significant and superior results were observed in app group, including body weight, exercise amount, waist circumference, body mass index, and systolic blood pressure when compared to booklet group. Conclusion: The lifestyle intervention supported with app was found to be superior to the booklet support for reducing body weight and maintaining exercise. Clinical Relevance: The lifestyle intervention program using mobile application support could be used widely for adults with metabolic syndrome in the community. Suggest nurses may incorporate this program in their health promotion strategies focusing on a healthy lifestyle to reduce the risk of progression to metabolic syndrome. [ABSTRACT FROM AUTHOR]

Prolonged wound discharge is a common postoperative complication of orthopaedic procedures and a risk factor for implant‐related infection. Occlusive wound closure methods have previously been suggested to reduce or even prevent this complication. We performed a randomised controlled trial on 70 patients who underwent surgical treatment for metastatic bone disease involving the proximal femur at our centre between January 2017 and August 2018. At conclusion of the tumour resection and endoprosthetic reconstruction procedure, patients were randomised to either occlusive wound closure (n = 35), using the Dermabond Prineo‐22 skin closure system, or routine wound closure with conventional skin staples (n = 35). Skin closure with occlusive wound closure resulted in a lesser degree (P <.0001) and shorter duration of postoperative wound discharge (HR 2.89 [95% CI 1.6–5.05], P <.0018). Compared with staples, surgical wounds were already dry after a mean of 3.5 days [95% CI 3.2–3.9] versus 6.1 days [95% CI 4.8–7.3] (P <.0001). Prolonged wound discharge for 7 days or more was observed in 23% of patients (n = 8) in the Staples‐group but was entirely absent in the occlusive wound closure group (P <.003). This study provides strong evidence that occlusive wound closure reduces frequency, degree, and duration of wound discharge in a patient population at particularly high risk for this complication. [ABSTRACT FROM AUTHOR]

Objectives: The primary aim was to investigate the effect of prefabricated foot orthoses on pain and function in people with chronic nonspecific low back pain (LBP). Secondary aims were to report on the recruitment rate, adherence to and safety of these interventions, and the relationship between physical activity and pain and function. Design: A two‐arm parallel group (intervention vs. control) randomised (1:1) controlled trial. Subjects: Forty‐one participants with chronic nonspecific LBP. Intervention: Twenty participants were randomised to the intervention group (prefabricated foot orthotic and The Back Book) and 21 to the control group (The Back Book). The primary outcomes for this study were change in pain and function from baseline to 12 weeks. Results: No statistically significant difference in pain was found between the intervention and control group (adjusted mean difference −0.84, 95% CI: −2.09 to 0.41, p = 0.18) at the 12‐week follow‐up. No statistically significant difference in function was found between the intervention and control group (adjusted mean difference −1.47, 95% CI: −5.51 to 2.57, p = 0.47) at the 12‐week follow‐up. Conclusion: This study found no evidence of a significant beneficial effect of prefabricated foot orthoses for chronic nonspecific LBP. This study demonstrated that the rate of recruitment, intervention adherence and safety, and participant retention is acceptable and supportive of conducting a larger randomised controlled trial. Australian and New Zealand Clinical Trials Registry (ACTRN12618001298202). [ABSTRACT FROM AUTHOR]

Aims: To test the effectiveness of a digital intervention to reduce cannabis use (ICan) with adherence‐focused guidance compared with educational cannabis information. Design: This was a single‐blind randomized controlled trial. Follow‐up clinical outcome measurements took place 3 and 6 months after randomization. Setting: The trial was conducted in the Netherlands. The intervention and guidance took place on‐line, with recruitment via Facebook/Instagram advertisement campaigns. Participants: Inclusion criteria were ≥ 18 years, cannabis use on ≥ 3 days/week, the desire to reduce/quit cannabis and using a smartphone. Participants were allocated to either ICan (n = 188) or control (n = 190) (69% male, mean age = 27.5 years). Intervention and comparator: ICan is a mobile (web‐)application based on motivational interviewing and cognitive behavioural therapy and includes three main components: screening, brief intervention (six modules) and referral to treatment. The control condition consisted of non‐interactive educational cannabis information. Measurements Primary outcome was the number of cannabis use days in the 7 days prior to the 6‐month follow‐up measurement. Secondary outcome measures at 3‐ and 6‐month follow‐up were the number of grams of cannabis used and attitudes towards seeking professional help for cannabis use related problems. Findings Intention‐to‐treat analysis showed that 6 months after randomization the mean number of cannabis use days in the past 7 days was reduced in both conditions (time P < 0.001), with no significant group × time interaction effect [ICan = 4.17 days, control = 4.31 days, Cohen's dbetween = 0.06, 95% confidence interval (CI) = −0.15, 0.26, P = 0.93]. Three months after randomization the mean number of grams used in the past 7 days was reduced in both conditions, with a significantly larger reduction in the ICan condition (P = 0.009, Cohen's dbetween = 0.15). At 6‐month follow‐up the significant group × time interaction effect was no longer present (P = 0.30). In both conditions, attitudes towards seeking professional help remained virtually unchanged over time. Conclusions: A digital intervention to reduce cannabis use (ICan) was more effective than non‐interactive educational cannabis information in reducing grams of cannabis used over 3 months, but not more effective at reducing cannabis use days at 6‐month follow‐up. Cannabis use reductions were maintained in both conditions between 3 and 6 months' follow‐up. [ABSTRACT FROM AUTHOR]

Background and Aims: Treatment of depression‐related psychological factors related to smoking behavior may improve rates of cessation among adults with major depressive disorder (MDD). This study measured the efficacy and safety of 12 weeks of behavioral activation for smoking cessation (BASC), varenicline and their combination. Design, Setting, Participants: This study used a randomized, placebo‐controlled, 2 × 2 factorial design comparing BASC versus standard behavioral treatment (ST) and varenicline versus placebo, taking place in research clinics at two urban universities in the United States. Participants comprised 300 hundred adult smokers with current or past MDD. Interventions: BASC integrated behavioral activation therapy and ST to increase engagement in rewarding activities by reducing avoidance, withdrawal and inactivity associated with depression. ST was based on the 2008 PHS Clinical Practice Guideline. Both treatments consisted of eight 45‐min sessions delivered between weeks 1 and 12. Varenicline and placebo were administered for 12 weeks between weeks 2 and 14. Measurements: Primary outcomes were bioverified intent‐to‐treat (ITT) 7‐day point‐prevalence abstinence at 27 weeks and adverse events (AEs). Findings No significant interaction was detected between behavioral treatment and pharmacotherapy at 27 weeks (χ2(1) = 0.19, P = 0.67). BASC and ST did not differ (χ2(1) = 0.43, P = 0.51). Significant differences in ITT abstinence rates (χ2(1) = 4.84, P = 0.03) emerged among pharmacotherapy arms (16.2% for varenicline, 7.5% for placebo), with results favoring varenicline over placebo (rate ratio = 2.16, 95% confidence interval = 1.08, 4.30). All significant differences in AE rates after start of medication were higher for placebo than varenicline. Conclusion: A randomized trial in smokers with major depressive disorder found that varenicline improved smoking abstinence versus placebo at 27 weeks without elevating rates of adverse events. Behavioral activation for smoking cessation did not outperform standard behavioral treatment, with or without adjunctive varenicline therapy. [ABSTRACT FROM AUTHOR]

Background: Exercise for people with whiplash associated disorder (WAD) induces hypoalgesic effects in some, but hyperalgesic effects in others. We investigated the exercise‐induced neurobiological effects of aerobic and strengthening exercise in individuals with chronic WAD. Methods: Sixteen participants (8 WAD, 8 pain‐free [CON]) were randomised to either aerobic or strengthening exercise. MRI for brain morphometry, functional MRI for brain connectivity, and magnetic resonance spectroscopy for brain biochemistry, were used at baseline and after the 8‐week intervention. Results: There were no differences in brain changes between exercise groups in either the WAD or CON group, therefore aerobic and strengthening data were combined to optimise sample size. After the exercise intervention, the CON group demonstrated increased cortical thickness (left parahippocampus: mean difference = 0.04, 95% CI = 0.07–0.00, p = 0.032; and left lateral orbital frontal cortex: mean difference = 0.03, 95% CI = 0.00–0.06, p = 0.048). The WAD group demonstrated an increase in prefrontal cortex (right medial orbital frontal) volume (mean difference = 95.57, 95% CI = 2.30–192.84, p = 0.046). Functional changes from baseline to follow‐up between the default mode network and the insula, cingulate cortex, temporal lobe, and somatosensory and motor cortices, were found in the CON group, but not in the WAD group. There were no changes post‐exercise in brain biochemistry. Conclusion: Aerobic and strengthening exercises did not exert differential effects on brain characteristics, however differences in structural and functional changes were found between WAD and CON groups. This suggests that an altered central pain modulatory response may be responsible for differential effects of exercise in individuals with chronic WAD. [ABSTRACT FROM AUTHOR]