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Background: Leaderboards are a highly popular gamification component used in student learning to enhance motivation, attentional engagement, and learning performance. However, few studies have examined the effects of individual leaderboard elements on English vocabulary learning through video lectures. Objectives: The present study aimed to examine how different leaderboard elements (i.e., points and rank) may affect students' English vocabulary learning through video lectures. Methods: A total of 34 students were assigned to groups using different leaderboard elements in a counterbalanced order. Participants' motivation, eye movements, and learning performance were measured and analysed. Results and Conclusions: Students' leaderboard rank was shown to increase their motivation regardless of whether other elements were present. Eye movement tracking revealed that the presence of the leaderboard increased students' saccades between the questions and the options, and lengthened their dwell time on the learning materials while reducing their dwell time on the non‐learning‐related screen areas. Presenting students' rank alone also improved their learning performance. Implications: Our findings strongly support the use of video lectures for English vocabulary learning, with the following recommendations: (1) Instructors should present students' rank on the leaderboard to enhance students' motivation and engagement; (2) Instructors should present only the students' rank on the leaderboard to also enhance students' learning performance. Lay Description: What is already known about this topic: While learning English vocabulary from video lectures, students might experience low levels of motivation and engagement, and pay less attention to the lectures.Leaderboards are a highly popular gamification component used in student learning to enhance motivation, attentional engagement, and learning performance.It remains unclear which leaderboard elements (i.e., points or rank) contribute most significantly to the effectiveness of the leaderboards. What this paper adds: Leaderboard elements have different effects on English vocabulary learning.The rank on the leaderboard benefited students' motivation and engagement.The rank also enhances students' confidence and learning performance. Implications for practice and/or policy: Instructors should present students' rank on the leaderboard to enhance students' motivation and engagement.Instructors should present only the students' rank on the leaderboard to also enhance students' learning performance. [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: 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: 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]

Background: Learning which letters correspond to which speech sounds is fundamental for learning to read. Based on previous experimental studies, we developed a serious game aiming to boost letter‐speech sound (L‐SS) correspondences in a motivational game environment. Objectives: The goal of this study was to determine the efficacy of this game in training L‐SS correspondences in pre‐readers. Additionally, an extended version of the game was developed given the importance of handwriting in audio‐visual integration. We established whether including a motoric component in the game boosted the letter‐speech sound training on top of the effect of the game without the motoric component. Methods: One‐hundred forty‐five kindergartners were randomly allocated to play either the standard audio‐visual version of the game, the motoric version or a control math game. All children were pre‐ and post‐tested on L‐SS knowledge and reading accuracy. Results and conclusions: We found that playing the game enhanced pre‐readers' L‐SS knowledge, but not reading accuracy, after a short, intensive intervention period of 3 weeks. However, children who played the motoric version of the game did not differ significantly from either the standard or the control condition. Implications: This game was efficient in training L‐SS correspondences in pre‐readers. These results suggest that this game might be useful as a preventive evidence‐based intervention for at‐risk children in kindergarten who might benefit from a head start before learning how to read. Future studies are needed to examine whether a longer intervention period results in L‐SS knowledge being translated into reading skills. Lay Description: What is already known about this topic: Automatised and fluent reading requires much exposure and practice, but intensive teacher support for all at‐risk readers is economically and practically unfeasibleHandwriting movement likely to enhance coupling of auditory and visual informationOne way to provide high exposure is with game‐based interventionsLack of studies examining the efficacy of these interventions What this paper adds: Serious game enhances letter‐speech sound knowledge in pre‐readers after 3 weeks of intensive interventionThis effect did not transfer to reading performanceNo additional effect of the handwriting movement, possibly due to the short intervention periodIn‐game measures slightly mediated intervention progress Implications for practice and/or policy: Growing evidence of game‐based interventions as promising tools to support reading developmentGame can possibly serve as evidence‐based intervention for at‐risk children in kindergarten who might benefit from a head start before learning how to read [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: 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: A total of 68% of pre‐school children with cleft palate have speech problems requiring speech therapy. There is a lack of access to regular targeted therapy. Parent training leads to positive outcomes in early communication skills in cleft palate and non‐cleft speech disorders. Connected health has been used to address inadequate access to therapy, providing intervention to those who would not otherwise receive therapy. Aims: To evaluate the speech, activity and participation outcomes of Parent Led, Therapist Supervised, Articulation Therapy (PLAT) compared with routine speech therapy intervention in parent–child dyads. Methods & Procedures: A total of 44 children, aged 2.9–7.5 years, were included in a two‐centre, two‐phase randomized controlled trial. Informed consent and assent were obtained. Participants and speech and language therapists (SLTs) were unblinded to the groups. Parents, in the parent‐trained group (n = 23), attended 2 days' training, received a detailed speech therapy programme, and undertook intervention over 12 weeks supported by the cleft specialist SLT using FaceTime and one face‐to‐face session. In the control arm (n = 21), parent–child dyads received six therapy sessions over 12 weeks with a research SLT, comparable with usual care. Speech recordings were undertaken pre‐ and post‐intervention. Percent consonant correct (PCC) was analysed by external SLTs blinded to the time and group. Activity and participation were measured using the Intelligibility in Context Scale (ICS) and Focus on Outcomes for Children Under Six (FOCUS) questionnaire. Outcomes & Results: There was no evidence of an interaction between Time and Group or an overall statistical difference between groups for PCC scores. There was a statistically significant difference over time for both groups (words: p < 0.002; confidence interval (CI) = 9.38–16.27; d = 0.57; sentences: p < 0.002; CI = 16.04–25.97; d = 0.23). Effect sizes were medium for words and small for sentences. For intelligibility and participation, there was no evidence of an interaction between Time and Group or an overall statistical difference between groups. A statistically significant difference over time was found for intelligibility (F = 29.97, d.f. = 1, 42, p < 0.001, 95 % CI = 1.45–3.15 d = 0.46) and for participation (F = 14.19, d.f. = 1, 41, p < 0.001 95% CI = 7.63–25.03; d = 0.36) with FOCUS results indicating clinically meaningful (parent‐led group) and significant (control group) change in participation. Conclusions & Implications: PLAT can be as effective as routine care in changing speech, activity and participation outcomes for children with cleft palate, when supported by a specialist cleft SLT using connected health. What this paper addsWhat is already known on this subjectOver 50% of children with cleft palate require speech therapy. However, there is a lack of timely, accessible speech therapy services in the UK and Ireland. Previous studies have shown that parents can deliver therapy effectively, and that connected health can support the delivery of speech therapy. This study aims to provide evidence that parent‐led therapy with the supervision of a specialist cleft therapist using FaceTime is effective.What this paper adds to existing knowledgeThis randomized controlled trial indicates that parents can be trained to deliver therapy for children with cleft palate speech disorders, under the supervision of an SLT. This approach results in improved speech, activity and participation outcomes similar to routine care.What are the potential or actual clinical implications of this work?This study indicates that both parent‐led articulation therapy and routine care showed meaningful gains in speech, activity and participation, and that parent‐led articulation therapy when supported by a cleft SLT using connected health could be an additional service delivery model for children with cleft palate speech disorders. [ABSTRACT FROM AUTHOR]

Virtual reality (VR) can promote design performance, and may generate a high cognitive load and affect creative design thinking as well. In order to examine the effect of VR application on cognitive load and engineering design creativity, this study recruited 81 eighth‐grade students as participants and employed a non‐equivalent‐groups quasi‐experimental design to examine how VR application influences creativity components and creative performance. A creativity component scale (creative motivation, creative thinking, and professional cognition), a measurement of creative performance, and a cognitive load scale were used to collect data. The study also investigated the ability of VR application to predict creativity components and creative performance, using cognitive load as the mediator. The conclusions are as follows: (1) VR application had marked effects on professional cognition and creative motivation but no effect on creative thinking skills. (2) VR application had marked effects on the novelty and usefulness aspects of creative performance, particularly with respect to usefulness. (3) VR application had marked effects on extraneous and germane cognitive load, but no influence on intrinsic cognitive load, and (4) Both VR application and cognitive load were able to predict creativity components and creative performance. Their abilities to predict creative performance approached an acceptable level. Nevertheless, VR application had no effect on general creative thinking skills; therefore, other teaching strategies are needed to strengthen creative thinking. Lay Description: What is already known about this topicVirtual reality (VR) can transmit complex knowledge.Virtual reality (VR) can promote design performance.What this paper addsInfluence of VR application on creativity components and creative performance.Ability of VR application and cognitive load to predict creativity components.Ability of VR application and cognitive load to predict creative performance.Implications for practice and/or policyUsing VR teaching to improve learning effects and creativity in high‐risk, expensive, and inaccessible learning fields.Using VR teaching to practice repeatedly, and facilitate basic understanding of the application. [ABSTRACT FROM AUTHOR]

While the educational disruption caused by the Covid‐19 pandemic underscores the importance of blended learning in higher education, research on the effectiveness of blended learning is still inconclusive. Drawing from the motivational design model of the ARCS (i.e., attention, relevance, confidence, and satisfaction), this study attempts to fill the gap to evaluate effectiveness of blended learning from a multi‐dimensional perspective. Participants were randomly assigned into three experimental groups (i.e., face‐to‐face, pure online, and blended). A questionnaire survey was administered in each group after the trial courses. The data was analysed by using the one‐way ANOVA with post hoc tests. The results showed that blended learning outperformed pure online learning in enhancing students' attention, confidence, and satisfaction perceptions. Additionally, blended learning had a higher level of satisfaction perception than face‐to‐face learning. Follow‐up interviews were also conducted to provide an in‐depth understanding of how blended learning motivated students during the learning process. Considering that blended learning may become a new normal in higher education after the Covid‐19 pandemic, the findings of the present study provide evidences to support the effectiveness of the blended learning approach in addressing students' motivational needs. Lay Description: What is already known about this topic?: Blended learning, also called as hybrid learning, is a learning approach that combines face‐to‐face learning with online learning;It is able to integrate benefits afforded by both traditional face‐to‐face learning and pure online learning to deliver course content;However, the findings concerned with the effectiveness of blended learning are mixed;The measurements of learning effectiveness in previous studies are often based on single variables (e.g., test score or students' satisfaction), but neglect the multi‐dimensional nature of learning effectiveness. What this paper adds?: Based on motivational design model of the ARCS (i.e., attention, relevance, confidence, and satisfaction), the present study compared the effectiveness of blended learning with other learning approaches (e.g., pure online learning and face‐to‐face learning) through a randomized experiment;It was identified that blended learning outperformed pure online learning in enhancing students' perceptions of attention, confidence, and satisfaction;Blended learning also had a higher level of satisfaction perception compared to face‐to‐face learning;Last but not least, evaluating learning effectiveness from an integrated lens of objective assessment based on test scores and subjective assessment based on the multi‐motivational perspectives is an important first step to understanding the effectiveness of blended learning to support learning in higher education in the future. Implications for practice and/or policy: As blended learning outperforms pure online in several motivational appeals, it is recommended that universities should consider conducting blended learning as far as possible rather than pure online learning;Learning strategies can be applied to trigger students' curiosity and keep them engaged continuously in the learning process, such as utilizing a variety of online quality resources, and interacting with students from other universities through online communities;As the confidence of taking blended learning courses varies among different levels of students, instructors should try to provide sufficient support during the learning process especially for the online sections;Since satisfaction is identified as a critical motivator, instructors should pay more attention on how to improve students' satisfaction through the design of blended learning, such as try controlling the length of course videos and interacting with students synchronously in the online course platforms;Last but not least, since some of the tasks in blended learning need to be initiated and completed by students themselves, it is necessary for educational institutions to consider incorporating the training for self‐regulation as part of their competence based training. [ABSTRACT FROM AUTHOR]

A promising method to support game‐based learning is to facilitate learners' externalization of cognitive and metacognitive processes. Externalizing Problem Representation (EPR) refers to a cognitive behaviour in which a learner constructs her own representations overtly. The purpose of this study is to investigate whether learning supports promoting EPR enhance qualitative understanding and quantitative proficiency in ratios and proportional relationships in a learning game (i.e., E‐Rebuild) context. Specifically, this study investigated the effects of representation format in problem representation on qualitative understanding and quantitative proficiency in a learning game context. The results of this study indicate that (a) symbolic learning supports better facilitate comprehension of math concepts and their relations than iconic learning supports in video game contexts, (b) symbolic learning supports better facilitate players' reflection for implicit understanding and promote their math problem‐solving skills, (c) participants in the symbolic learning support group increased significantly in qualitative understanding but not in quantitative proficiency after gameplay, and (d) participants in the iconic learning support group experienced significant growth in quantitative proficiency but not in qualitative understanding after gameplay. Lay Description: What is already known about this topic: Video games potentially facilitate implicit qualitative understanding more than quantitative knowledge test performance.Educational game designers lack a good understanding of the design and development of effective learning supports in educational games. What this paper adds: Symbolic learning supports for problem representation better facilitate comprehension of math concepts and their relations than iconic learning supports in video game contexts.Participants experienced significant growth in quantitative proficiency after they processed the iconic in‐game learning supports in game‐based math tasks.Participants' qualitative understanding in the symbolic learning support group increased significantly after playing E‐Rebuild‐based math game task. Implications for practice and/or policy: This study informs scholars and designers of game‐based learning about designing learning support and its properties in video game contexts: Learning support design to promote math problem representation across problem translation and problem integration.This study provides design principles for learning supports in math learning game; symbolic learning supports facilitate qualitative understanding whereas iconic learning supports facilitate quantitative proficiency in math learning game. [ABSTRACT FROM AUTHOR]

Aim The aim of this systematic review was to evaluate the efficacy of anti-plaque chemical formulations for managing gingivitis, in 6-month, home-use, randomised clinical trials ( RCTs). Material and Methods A protocol was designed, including inclusion and exclusion criteria to identify RCTs assessing gingival and/or bleeding indices. Electronic and hand-searches identified relevant papers, which were screened and evaluated for inclusion. Full-papers were retrieved and relevant information was extracted (also plaque indices), including quality and risk of bias. Mean treatment effects were calculated to obtain weighted mean differences ( WMD) and 95% confidence intervals. Results After the process of screening and selection, 87 articles with 133 comparisons, were included in the review. The additional effects of the tested products were statistically significant in terms of Löe & Silness gingival index (46 comparisons, WMD −0.217), modified gingival index ( n = 23, −0.415), gingivitis severity index ( n = 26, −14.939%) or bleeding index ( n = 23, −7.626%), with significant heterogeneity. For plaque, additional effects were found for Turesky (66 studies, WMD −0.475), Silness & Löe ( n = 26, −0.109), and plaque severity ( n = 12, −23.4%) indices, with significant heterogeneity. Conclusion Within the limitations of the present study, formulations with specific agents for chemical plaque control provide statistically significant improvements in terms of gingival, bleeding and plaque indices. [ABSTRACT FROM AUTHOR]

The use and development of mobile interventions are experiencing rapid growth. In "just-in-time" mobile interventions, treatments are provided via a mobile device, and they are intended to help an individual make healthy decisions 'in the moment,' and thus have a proximal, near future impact. Currently, the development of mobile interventions is proceeding at a much faster pace than that of associated data science methods. A first step toward developing data-based methods is to provide an experimental design for testing the proximal effects of these just-in-time treatments. In this paper, we propose a 'micro-randomized' trial design for this purpose. In a micro-randomized trial, treatments are sequentially randomized throughout the conduct of the study, with the result that each participant may be randomized at the 100s or 1000s of occasions at which a treatment might be provided. Further, we develop a test statistic for assessing the proximal effect of a treatment as well as an associated sample size calculator. We conduct simulation evaluations of the sample size calculator in various settings. Rules of thumb that might be used in designing a micro-randomized trial are discussed. This work is motivated by our collaboration on the HeartSteps mobile application designed to increase physical activity. Copyright © 2015 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Migraine has close associations with depression and anxiety. Catastrophizing, an alarmist reaction to pain, has been proposed as one of the mediators in the relationship between headache and emotional distress. However, much experimental evidence is needed to make such a view more validated. The aims of this study are to examine the effects of mood induction on the pain responses and to investigate the role of pain catastrophizing in the relationship between pain and mood amongst a sample of patients with migraine. For this purpose, 60 patients with migraine were recruited from a headache clinic in Tehran-Iran and were randomly assigned into one of three groups: negative mood induced group, positive mood induced group and control group. The following instruments and measures were used in this study: mood induction by presenting different types of films (positive, negative), a computerized cognitive task to elicit pain, Beck Depression Inventory and Pain Catastrophizing Scale. The results showed that while the induction of depressed mood increased the pain intensity, the induction of positive mood reduced it significantly ( p < 0.05). Further analyses revealed that catastrophizing is as a confounding factor in the relationship between pain and mood. Once catastrophizing scores were entered into the analyses as a covariate, the significant effect of mood on the pain intensity reduced. In conclusion, both mood and catastrophizing are important factors in understanding the migraine pain. Clinical implications of these findings are discussed in the paper. Copyright © 2014 John Wiley & Sons, Ltd. Key Practitioner Message Pain-related catastrophizing and mood induction are important factors in understanding pain intensity amongst patients with migraine pain., Catastrophizing as a confounding factor in the relationship between pain and mood may partially mediate the relationship between mood and pain., Therapeutic interventions should focus on the reduction of depression and catastrophizing. [ABSTRACT FROM AUTHOR]

Background Over the past 60 years, the view that 'alcoholism' is a disease for which the only acceptable goal of treatment is abstinence has given way to the recognition that alcohol use disorders ( AUDs) occur on a continuum of severity, for which a variety of treatment options are appropriate. However, because the available treatments for AUDs are not effective for everyone, more research is needed to develop novel and more efficacious treatments to address the range of AUD severity in diverse populations. Here we offer recommendations for the design and analysis of alcohol treatment trials, with a specific focus on the careful conduct of randomized clinical trials of medications and nonpharmacological interventions for AUDs. Methods This paper provides a narrative review of the quality of published clinical trials and recommendations for the optimal design and analysis of treatment trials for AUDs. Results Despite considerable improvements in the design of alcohol clinical trials over the past 2 decades, many studies of AUD treatments have used faulty design features and statistical methods that are known to produce biased estimates of treatment efficacy. Conclusions The published statistical and methodological literatures provide clear guidance on methods to improve clinical trial design and analysis. Consistent use of state-of-the-art design features and analytic approaches will enhance the internal and external validity of treatment trials for AUDs across the spectrum of severity. The ultimate result of this attention to methodological rigor is that better treatment options will be identified for patients with an AUD. [ABSTRACT FROM AUTHOR]

Background/aim Engagement in desired occupations can promote health and wellbeing in older adults. Assessments of engagement often measure frequency, amount or importance of specific activities. This study aimed to develop a scale to measure older adults' evaluation of the extent to which their everyday activities are contributing to their health and wellness. Methods Eighteen items, each scored with a seven-point rating scale, were initially developed by content experts, covering perceptions of how daily activities contribute to physical and mental health, as well as satisfaction and activity participation in the last six months. Rasch analysis methods were used to refine the scale using the pencil and paper responses of 460 community-living older adults. Results Initial Rasch analysis indicated three unlabelled rating scale categories were seldom used, reducing measurement precision. Five items were conceptually different by misfit statistics and principal component analysis. Subsequently, those items were removed and the number of rating scale steps reduced to 4. The remaining 13-item, 4-step scale, termed the Activity Significance Personal Evaluation ( ASPEn), formed a unidimensional hierarchy with good fit statistics and targeting. Person separation reliability (2.7) and internal consistency (.91) indicated the tool is appropriate for individual person measurement. Relative validity indicated equivalence between Rasch measures and total raw scores. Conclusions ASPEn is a brief, easily administered assessment of older adults' perception of the contribution of everyday activities to personal health and wellness. ASPEn may facilitate occupational therapy practice by enabling clinicians to assess change in meaning of an older adult's activity over time. [ABSTRACT FROM AUTHOR]

Background The effectiveness of two treatment approaches (phonological therapy and articulation therapy) for treatment of 14 children, aged 4;0-6;7 years, with phonologically based speech-sound disorder (SSD) has been previously analysed with severity outcome measures (percentage of consonants correct score, percentage occurrence of phonological processes and phonetic inventory). Considering that the ultimate goal of intervention for children with phonologically based SSD is to improve intelligibility, it is curious that intervention studies focusing on children's phonology do not routinely use intelligibility as an outcome measure. It is therefore important that the impact of interventions on speech intelligibility is explored. Aims This paper investigates the effectiveness of the two treatment approaches (phonological therapy and articulation therapy) using intelligibility measures, both in single words and in continuous speech, as the primary outcome. Methods & Procedures Fourteen children with phonologically based SSD participated in the intervention. The children were randomly assigned to phonological therapy or articulation therapy (seven children in each group). Two assessment methods were used for measuring intelligibility: a word identification task (for single words) and a rating scale (for continuous speech). Twenty-one unfamiliar adults listened and judged the children's intelligibility. Reliability analyses showed overall high agreement between listeners across both methods. Outcomes & Results Significant improvements were noted in intelligibility in both single words (paired t(6) = 4.409, p = 0.005) and continuous speech (asymptotic Z = 2.371, p = 0.018) for the group receiving phonology therapy pre- to post-treatment, but no differences in intelligibility were found for those receiving the articulation therapy pre- to post-treatment, either for single words (paired t(6) = 1.763, p = 0.128) or continuous speech (asymptotic Z = 1.442, p = 0.149). Conclusions & Implications Intelligibility measures were sensitive enough to show changes in the phonological therapy group but not in the articulation therapy group. These findings emphasize the importance of using intelligibility as an outcome measure to complement the results obtained with other severity measures when exploring the effectiveness of speech interventions. This study presents new evidence for the effectiveness of phonological therapy in improving intelligibility with children with SSD. [ABSTRACT FROM AUTHOR]

Background Previous studies have reported that obese people with trisomy 21 suffer from lowgrade systemic inflammation. A recent study has found that aerobic training reduced inflammation in obese women with Down syndrome. To the best of our knowledge, the study reported in this paper is the first to determine for how long these effects were maintained after completion of the programme. Methods Twenty premenopausal obese women (18-30 years old) with Down syndrome volunteered for this study. Eleven were randomly assigned to the intervention group and performed a 10-week aerobic training programme, 3 sessions per week, consisting of warming-up followed by treadmill exercise (30-40 min) at a work intensity of 55-65% of peak heart rate and a cooling-down period. The control group included 9, age, sex and BMI matched women with Down syndrome that did not perform any training programme. Fat mass percentage and distribution were measured. Plasma level of IL-6 and high-sensitive C-reactive protein (hs-CRP) were monitored. Time-course changes for these outcomes were assessed at pre- and post-intervention. Further, they were re-evaluated at 1, 3 and 6 months after completion of the programme. Results Three months after completion of the programme, plasma levels of IL-6 and hs-CRP were significantly increased. Up to 6 months later, both fat mass percentage and waist circumference (WC) were significantly increased. Furthermore, physical fitness was also impaired in the intervention group. No changes were observed in the control group. Conclusion A 3-month detraining period significantly impaired chronic inflammation in obese women with DS. [ABSTRACT FROM AUTHOR]

Objectives Lipoatrophy is a long-term adverse effect of some antiretrovirals that affects quality of life, compromises adherence and may limit the clinical impact of HIV treatments. This paper explores the effect of tenofovir/emtricitabine ( TDF/ FTC) on the amount of limb fat in patients with virological suppression. Methods A randomized, prospective clinical trial was performed to compare continuation on a zidovudine/lamivudine ( ZDV/3TC)-based regimen with switching to a TDF/ FTC-based regimen in terms of the effect on limb fat mass as assessed by DEXA over a 72-week period. Results Eighty patients were included (39 in the TDF/ FTC arm and 41 in the ZDV/3 TC arm) and 73 completed the study (37 and 36, respectively). In the switch arm, limb fat increased by a median of 540 g from baseline ( P = 0.022), while in the ZDV/3TC arm it decreased by a median of 379 g ( P = 0.112; p between groups = 0.007). Subjects with baseline limb fat ≤ 7200 g, previous time on ZDV > 5 years or a body mass index > 25 kg/m2 experienced higher limb fat gains than other subjects, and these differences were statistically significant. Haemoglobin increased by a median of 1.0 g/d L in the TDF/ FTC arm ( P < 0.001) and remained unchanged in the ZDV/3TC arm (p between groups = 0.0002). There were no significant differences between groups in other secondary endpoints (body weight, total body and trunk fat content, total body bone mineral density, laboratory parameters, CD4 cell count and viral load). Conclusions Switching from a ZDV/3TC-based to a TDF/ FTC-based regimen led to a statistically significant improvement in limb fat, in contrast to the progressive loss of limb fat in subjects continuing ZDV/3TC. [ABSTRACT FROM AUTHOR]

Aims This study examines the preliminary outcomes of an intervention targeting service providers in methadone maintenance therapy ( MMT) clinics in China. The intervention effects on both service providers and clients are reported. Design The MMT CARE intervention pilot was developed and implemented collaboratively with local health educators. After three group intervention sessions, trained providers in intervention clinics delivered two individual motivational interviewing sessions with their clients. Settings Six clinics in Sichuan, China, were randomized to either the MMT CARE intervention condition or a standard care condition. Participants A total of 41 providers and 179 clients were sampled from the six clinics. Measurements At baseline and three-, six-, and nine-month assessments, providers completed self-administrated paper/pencil questionnaires regarding provider-client interaction, MMT knowledge, perceived job-related stigma and clinic support. Clients completed a face-to-face survey about their concurrent drug use and drug avoidance self-efficacy. Mixed-effects regression models with clinic-level random effect were used to assess the intervention effects. Findings Significant intervention effects for providers were found in improved MMT knowledge, provider-client interaction and perceived clinic support. For clients, better improvements in drug avoidance self-efficacy and reduced concurrent drug use were observed for the intervention compared with the standard care group. Conclusions The MMT CARE intervention targeting providers in methadone maintenance clinics can improve providers' treatment knowledge and their interaction with clients. The intervention can also reduce clients' drug-using behavior through motivational interviewing sessions conducted by trained providers. [ABSTRACT FROM AUTHOR]

Objective This paper presents the final analysis of once-daily darunavir/ritonavir ( DRV/r) vs. lopinavir/ritonavir ( LPV/r) in treatment-naïve HIV-1-infected adults. Methods ARTEMIS ( AntiRetroviral Therapy with TMC114 ExaMined In naïve Subjects; NCT00258557) was a randomized, open-label, phase- III, 192-week trial. Patients were stratified by baseline HIV-1 RNA and CD4 count, and randomized to once-daily DRV/r 800/100 mg or LPV/r 800/200 mg total daily dose (either once or twice daily) plus tenofovir/emtricitabine. Results Of 689 randomized patients receiving treatment ( DRV/r: 343; LPV/r: 346), 85 and 114 patients in the DRV/r and LPV/r arms, respectively, had discontinued by week 192. Noninferiority was shown in the primary endpoint of virological response ( HIV-1 RNA < 50 copies/ mL) [ DRV/r: 68.8%; LPV/r: 57.2%; P < 0.001; intent to treat ( ITT)/time to loss of virological response; estimated difference in response 11.6% (95% confidence interval 4.4-18.8%)]. Statistical superiority in virological response of DRV/r over LPV/r was demonstrated for the primary endpoint ( P = 0.002) and for the ITT non-virological-failure-censored analysis (87.4% vs. 80.8%, respectively; P = 0.040). No protease inhibitor ( PI) primary mutations developed and only low levels of nucleoside reverse transcriptase inhibitor ( NRTI) resistance developed in virological failures in both groups. Significantly fewer discontinuations because of adverse events were observed with DRV/r (4.7%) than with LPV/r (12.7%; P = 0.005). Grade 2-4 treatment-related diarrhoea was significantly less frequent with DRV/r than with LPV/r (5.0% vs. 11.3%, respectively; P = 0.003). DRV/r was associated with smaller median increases in total cholesterol and triglyceride levels than LPV/r. Changes in low- and high-density lipoprotein cholesterol were similar between groups. Similar increases in aspartate aminotransferase and alanine aminotransferase for DRV/r and LPV/r were observed. Conclusion Over 192 weeks, once-daily DRV/r was noninferior and statistically superior in virological response to LPV/r, with a more favourable gastrointestinal profile, demonstrating its suitability for long-term use in treatment-naïve patients. [ABSTRACT FROM AUTHOR]