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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]

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]

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: 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: 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]

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]

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]

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]

Background and Purpose Sciatica is a common clinical condition that can be extremely painful, disabling and life-changing. Whether conservative or surgical treatment for sciatica secondary to an intervertebral disc prolapse is most effective is still much debated. An important component of conservative treatment is physiotherapy, which aims to promote physical and psychological health for the patient, whilst resorption of the disc takes place. This paper reports a qualitative study of patients' views and experiences of a bespoke physiotherapy intervention for the treatment of sciatica. Methods A qualitative study nested within a pilot randomized controlled trial of bespoke physiotherapy for the treatment of patients with sciatica awaiting lumbar microdiscectomy surgery. Patients randomized to receive bespoke physiotherapy in the intervention arm of the trial were invited to take part in semi-structured interviews. Twenty-one in-depth, semi-structured interviews took place. All interviews were recorded, fully transcribed and thematically analysed. Results Most patients in the sample found the physiotherapy valuable, appreciating the individual nature of the approach, the exercises to reduce pain and discomfort, techniques for improving functional spinal movement, walking and dynamic posture, and manual therapy and cardiovascular exercise. A small number did not find the physiotherapy of benefit. Sixteen patients in the sample went on to proceed with surgery, but most of these found value in having had the physiotherapy first. Discussion Many patients with sciatica appreciate the value of physiotherapy prior to surgery. Future research should examine patients' experiences of bespoke physiotherapy delivered within primary care. Copyright © 2016 The Authors Physiotherapy Research International published by 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 The primary goals in conducting clinical trials of treatments for alcohol use disorders ( AUDs) are to identify efficacious treatments and determine which treatments are most efficacious for which patients. Accurate reporting of study design features and results is imperative to enable readers of research reports to evaluate to what extent a study has achieved these goals. Guidance on quality of clinical trial reporting has evolved substantially over the past 2 decades, primarily through the publication and widespread adoption of the Consolidated Standards of Reporting Trials statement. However, there is room to improve the adoption of those standards in reporting the design and findings of treatment trials for AUD. Methods This paper provides a narrative review of guidance on reporting quality in AUD treatment trials. Results Despite improvements in the reporting of results of treatment trials for AUD over the past 2 decades, many published reports provide insufficient information on design or methods. Conclusions The reporting of alcohol treatment trial design, analysis, and results requires improvement in 4 primary areas: (i) trial registration, (ii) procedures for recruitment and retention, (iii) procedures for randomization and intervention design considerations, and (iv) statistical methods used to assess treatment efficacy. Improvements in these areas and the adoption of reporting standards by authors, reviewers, and editors are critical to an accurate assessment of the reliability and validity of treatment effects. Continued developments in this area are needed to move AUD treatment research forward via systematic reviews and meta-analyses that maximize the utility of completed studies. [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 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]

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]

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]

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]

Background: Sensitive responsiveness is an important aspect in affect‐regulation of people with severe to profound intellectual disabilities. Aim: This randomized controlled trial evaluated the Attune & Stimulate‐checklist, a tool for detecting subtle and idiosyncratic communicative behaviours and responding adequately. Methods: Effects on the sensitive responsiveness of professional caregivers and the arousal and valence of adults with severe to profound intellectual disabilities were investigated. Video recordings of 102 interactions were analysed with several observation instruments. Results: Although no significant effect was found on the checklist‐suggestions of responsive behaviours (d = 0.33, p =.052), the intervention increased caregivers' sensitive responsive and affective behaviour (d = 0.94 – 1.10, p <.001) and clients' optimal arousal (d = 0.48, p =.019) and interactive engagement (d = 0.40 – 0.48, p =.018 ‐.050). Conclusion: This low‐intensity intervention had a medium to large immediate effect on the interaction. Future research should investigate medium‐ and long‐term effects. [ABSTRACT FROM AUTHOR]

Aim: The aim of the present study was to compare performance 5 h after a 90‐min endurance training session when either carbohydrate only or carbohydrate with added whey hydrolysate or whey isolate was ingested during the first 2 h of the recovery period. Methods: Thirteen highly trained competitive male cyclists completed three exercise and diet interventions (double‐blinded, randomized, crossover design) separated by 1 week. The 90‐min morning session (EX1) included a 60 min time‐trial (TT60). Immediately and 1 h after exercise, participants ingested either (1) 1.2 g carbohydrate∙kg−1∙h−1 (CHO), (2) 0.8 g carbohydrate∙kg−1∙h−1 + 0.4 g isolate whey protein∙kg−1∙h−1 (ISO) or (3) 0.8 g carbohydrate∙kg−1∙h−1 + 0.4 g hydrolysate whey protein∙kg−1∙h−1 (HYD). Additional intakes were identical between interventions. After 5 h of recovery, participants completed a time‐trial performance (TTP) during which a specific amount of work was performed. Blood and urine were collected throughout the day. Results: TTP did not differ significantly between dietary interventions (CHO: 43:54 ± 1:36, ISO: 46:55 ± 2:32, HYD: 44:31 ± 2:01 min). Nitrogen balance during CHO was lower than ISO (p < 0.0001) and HYD (p < 0.0001), with no difference between ISO and HYD (p = 0.317). In recovery, the area under the curve for blood glucose was higher in CHO compared to ISO and HYD. HR, VO2, RER, glucose, and lactate during EX2 were similar between interventions. Conclusion: Performance did not differ after 5 h of recovery whether carbohydrate only or isocaloric carbohydrate plus protein was ingested during the first 2 h. Correspondingly, participants were not in negative nitrogen balance in any dietary intervention. [ABSTRACT FROM AUTHOR]

Background: Children's pain in dentistry has undesirable short‐ and long‐term consequences; therefore, less invasive treatments merit consideration. Aim: To investigate procedural pain scores for two treatments for carious primary molars in New Zealand primary care. Design: This study was a split‐mouth randomised control trial, with secondary outcome analysis. Children (4–8 years) with proximal carious lesions on matched primary molars had one tooth treated with the Hall technique (HT) and one treated with a conventional stainless steel crown (CT); treatment type and order of treatment were randomly allocated (allocation concealment). The Wong–Baker self‐report pain scale measured pretreatment dental pain, procedural pain at each treatment and post‐operative pain. Results: Data were analysed for 103 children: 49 children had the HT first and 54 children had the CT first. Procedural pain scores did not differ by treatment type, with 71.8% and 76.7% of children reporting low pain for the HT and the CT, respectively. Fewer children reported low procedural pain for the second treatment than the first (p =.047). Most children reported low procedural pain for both treatments (58.3%), although 41.7% experienced moderate–high procedural pain with at least one treatment. Conclusions: The HT caused pain for as many children as the CT. There is an opportunity for better dental pain management in this setting. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to compare the efficacy of e‐flipped and online case‐based workshops on the nurses' knowledge, attitude and behaviour regarding thalassemia during the COVID‐19 pandemic. Design: A pre‐test–posttest interventional study was conducted with two intervention groups and a control group. Methods: One hundred and fifty nurses were recruited from comprehensive urban health centres in June–December 2020. The nurses were randomly allocated to one of the three groups: case‐based e‐flipped workshop (n = 50), case‐based online workshop (n = 50) and control (n = 50). A researcher‐made questionnaire was completed by eligible subjects at baseline, after the end of the training sessions and 4 weeks after interventions to assess their knowledge, attitude and behaviour. Data were analysed in IBM SPSS v16.0. ANOVA and Tukey's post hoc tests were used to compare the three groups. Results: The mean knowledge, attitude and behaviour scores in the intervention groups increased significantly more than that in the control group (p <.001). One week and 4 weeks following the intervention, the mean score of knowledge, attitude and behaviour in the e‐flipped group was greater than that in the online group (p <.001). According to the results, e‐flipped and online case‐based workshops can improve nurses' knowledge, attitude and behaviour regarding thalassemia. [ABSTRACT FROM AUTHOR]

Objectives: To determine the efficacy of four different oral hygiene protocols involving adjunctive interdental devices in terms of plaque and bleeding scores in periodontitis‐affected patients. Material and methods: This was a randomized clinical trial with a 5‐week follow‐up, including previously treated periodontitis patients not undergoing any supportive care. Patients were randomly allocated to 4 groups: manual toothbrush (group TB); toothbrush plus dental floss (group TB/F); toothbrush plus interdental brushes (group TB/IDB) and toothbrush plus rubber interdental picks (group TB/RIDB). Oral hygiene instructions (OHI) were provided at baseline (T‐7) and at T0 (1‐week) then bi‐weekly (T14/T28). At T0, supragingival professional cleaning was delivered. Plaque and bleeding indexes were taken at all timepoints by a single calibrated examiner, blind to group allocation. Results: At T‐7, patients were comparable for age, body mass index (BMI) and all clinical parameters, exceptions for the Interdental Angulated Bleeding Index. At T28, significant reductions of plaque and gingival inflammation were noted in all groups (p < 0.001) and within the expected ranges. Intergroup comparisons identified that group TB/IDB and group TB/RIDB achieved lower levels of plaque and inflammation than group TB (p < 0.05). Group TB/IDB and group TB/RIDB showed lower levels of plaque and lower inflammation as measured by angulated bleeding index than group TB/RIDB (p < 0.05). Conclusion: Interdental brushes and rubber interdental picks were more efficient than toothbrushing alone and toothbrushing and floss in reducing plaque and gingival inflammation measured in a periodontitis‐affected population. [ABSTRACT FROM AUTHOR]

Objective: To participate in shared decision making (SDM), patients need to understand their options and develop trust in their own decision‐making abilities. Two experiments investigated the potential of decision aids (DAs) in preparing patients for SDM by raising awareness of preference‐sensitivity (Study 1) and showing possible personal motives for decision making (Study 2) in addition to providing information about the treatment options. Methods: Participants (Study 1: N = 117; Study 2: N = 217) were put into two scenarios (Study 1: cruciate ligament rupture; Study 2: contraception), watched a consultation video and were randomized into one of three groups where they received additional information in the form of (a) narrative patient testimonials; (b) non‐narrative decision strategies; and (c) an unrelated text (control group). Results: Participants who viewed the patient testimonials or decision strategies felt better prepared for a decision (Study 1: P <.001, ηP2 = 0.43; Study 2: P <.001, ηP2 = 0.57) and evaluated the decision‐making process more positively (Study 2: P <.001, ηP2 = 0.13) than participants in the control condition. Decision certainty (Study 1: P <.001, ηP2 = 0.05) and satisfaction (Study 1: P <.001, ηP2 = 0.11; Study 2: P =.003, d = 0.29) were higher across all conditions after watching the consultation video, and certainty and satisfaction were lower in the control condition (Study 2: P <.001, ηP2 = 0.05). Discussion: Decision aids that explain preference‐sensitivity and personal motives can be beneficial for improving people's feelings of being prepared and their perception of the decision‐making process. To reach decision certainty and satisfaction, being well informed of one's options is particularly relevant. We discuss the implications of our findings for future research and the design of DAs. [ABSTRACT FROM AUTHOR]

Multiple micronutrient deficiencies (MNDs) co‐exist, often because of poor intakes and adversely impact health. Habitual diets were assessed in 300 school children (6–17 years old) recruited from two government schools by simple random sampling. Probability of adequacy (PA) for 11 micronutrients and mean probability of adequacy (MPA) was calculated. Haemoglobin, plasma ferritin, folic acid, vitamin B12 and C‐reactive protein were estimated. Descriptive statistics and regression analysis were used to estimate magnitude and factors associated with MNDs. The contribution of fortified foods and/or supplements in addressing inadequacies and excessive intakes was modelled. The PA ranged from 0.04 for folate to 0.70 for zinc, and the MPA was 0.27. Prevalence of anaemia (53%), iron deficiency (57%; ID), iron deficiency anaemia (38%; IDA), folate deficiency (24%) and B12 deficiency (43%) was high. Dietary inadequacy of iron, zinc and a low MPA was associated with anaemia and IDA. Inclusion of double fortified salt (DFS), fortified rice (FR) or iron folic acid (IFA) supplements individually in habitual diet reduced probability of iron inadequacy significantly from 82% to ≤13%. Inclusion of DFS and FR simultaneously led to disappearance of iron inadequacy, but risk of excessive intake increased to 16%. Inclusion of DFS, FR and IFA together increased risk of excess iron intake to 40%. Nevertheless, intakes of folate and B12 remained inadequate even with FR and/or IFA. These results indicate a high risk of dietary MNDs in children and suggest need for more systematic intake measurements in representative sample and adjustment of iron dosages to avoid excessive intakes. [ABSTRACT FROM AUTHOR]

Background: Self‐management interventions in COPD, including action plans, have the potential to increase quality of life and to reduce respiratory‐related hospitalisations. However, knowledge is still sparse of the effectiveness of a personally tailored action plan introduced at or right after discharge from hospital. Aim: This pilot study aimed to test whether a personalised, stepwise action plan supported with a short instruction provided at or postdischarge after an acute exacerbation in chronic obstructive pulmonary disease admission as an addition to usual care reduces readmissions and symptom burden, including anxiety and depression levels at 3‐month follow‐up. Methods: The study was carried out in a randomised controlled design with follow‐up after 3 months. In all, 75 participants were randomly assigned to either an intervention group that received an action plan, including the COPD Assessment Test (CAT), or to a control group that received usual care. The incidence of COPD‐related readmissions was measured as the primary outcome. Results: Compared to the control group, the action plan group significantly reduced the incidence of readmissions. The action plan group showed a trend towards a significant decrease in HADS‐depression, but none in HADS‐anxiety. Significant improvements in CAT scores were observed for the participants in the intervention group. Only inferior minor differences were found in use of inhalation therapy. Conclusions: A personally tailored action plan introduced at or postdischarge combined with follow‐up support is an effective self‐management tool to support recovery and to reduce unnecessary readmissions. In future follow‐up care, the healthcare professional must initiate the action plan at discharge and immediately after having the opportunity to follow the patient at home. This might require healthcare professionals working across healthcare sectors, who support patients until they have the needed confidence and competence in using the plan. [ABSTRACT FROM AUTHOR]

Objective: This study investigated the effect of the Jennings Disaster Nursing Management Model‐based and learning management system‐assisted six‐module training programme on nursing students' disaster preparedness perceptions and response self‐efficacy. Design and sample: This randomized controlled trial used a two group comparison design, experimental group (n = 127), and control group (n = 108), carried out with third‐year nursing students in a city in the west of Turkey. Measures: Data included a socio‐demographic form, the Disaster Preparedness Perception Scale in Nurses (DPPSN) and the Disaster Response Self‐Efficacy Scale (DRSES). Results: After the training, disaster preparedness perceptions and the response self‐efficacy of the EG increased significantly (p <.05). This study had a moderate effect on participants' knowledge and self‐efficacy. Conclusion: Public health nurses are health professionals with important roles and responsibilities in the stages of disaster preparedness, response, and recovery that is all stages of disaster management. This theoretical‐based program can be considered for both students and nursing professionals. [ABSTRACT FROM AUTHOR]

Objectives: The effects of different physiotherapy protocols on patients suffering from grade‐I spondylolisthesis have been thus far examined in a limited number of clinical trials. Therefore, the main purpose of this study was to compare the effects of lumbar segmental stabilization and general exercises on clinical and radiologic criteria in grade‐I spondylolisthesis patients. Methods: This study was a double‐blind randomized controlled trial (RCT) with a test–retest design and parallel groups. A total of 26 patients with grade‐I spondylolisthesis were thus randomly assigned to experimental group (13 patients, lumbar segmental stabilization exercises) and control group (13 patients, general exercises). Subsequently, pain, functional disability, kinesiophobia, translational motion, angular motion and slip percentage of the vertebra were investigated. Results: Of the 120 people recruited in this study, only 26 patients were eligible. According to pre/post‐intervention comparison, a statistically significant decrease was observed in the experimental group in terms of pain (p = 0.000), functional disability (p = 0.004), kinesiophobia (p = 0.002), translational motion (p = 0.043) and angular motion (p = 0.011), but not for slip percentage (p = 0.122). Considering the control group, a statistically significant decline was reported for pain (p = 0.043) and functional disability (p = 0.002). However, no significant differences were found for other variables in the control group. With regard to inter‐group comparison, there was no statistically significant difference between the two groups regarding the given variables except for kinesiophobia (p = 0.040). Conclusion: Both lumbar segmental stabilization and general exercises led to reduction in pain and functional disability of patients with grade‐I spondylolisthesis. Therefore, lumbar segmental stabilization exercises seemed to be better than general ones with reference to improving kinesiophobia and intervertebral movements. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to develop an objective method to assess the degree of bristle splaying of used manual toothbrushes and to investigate their plaque removal efficacy. Methods: A randomized controlled trial targeting Hiroshima University students was performed to assess the plaque removal efficacy of polybutylene terephthalate (PBT) manual toothbrushes. Participants were randomly assigned to the soft toothbrush group (n = 40) or the medium toothbrush group (n = 40). A small number of participants discontinued the intervention for personal reasons in both the medium (n = 6) and soft (n = 2) toothbrush groups. Toothbrushes were collected immediately after first use (T0: baseline), after 1 month of use (T1: month 1), after 2 months of use (T2: month 3) and after 3 months of use (T3: month 6), following the allocation of a new toothbrush. The bristle surface area was measured using digital software. Results: The surface area of the bristles was significantly greater at T1, T2 and T3 than at T0 in the medium toothbrush group (n = 34) and soft toothbrush group (n = 38) (P <.001). Importantly, plaque removal efficacy, calculated from a modified plaque control record score and modified patient hygiene performance score, was significantly lower at T2 than at T0 in both groups. Conclusions: Our method for evaluation of bristle splaying is considered to be reliable and reproducible. PBT toothbrushes may become less effective after two months of use. [ABSTRACT FROM AUTHOR]

Introduction: Intravenous (IV) fluid is a key intervention in the management of septic shock. The benefits and harms of lower versus higher fluid volumes are unknown and thus clinical equipoise exists. We describe the protocol and detailed statistical analysis plan for the conservative versus liberal approach to fluid therapy of septic shock in the Intensive Care (CLASSIC) trial. The aim of the CLASSIC trial is to assess benefits and harms of IV fluid restriction versus standard care in adult intensive care unit (ICU) patients with septic shock.Methods: CLASSIC trial is an investigator-initiated, international, randomised, stratified, and analyst-blinded trial. We will allocate 1554 adult patients with septic shock, who are planned to be or are admitted to an ICU, to IV fluid restriction versus standard care. The primary outcome is mortality at day 90. Secondary outcomes are serious adverse events (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), and cognitive function at 1 year. We will conduct the statistical analyses according to a pre-defined statistical analysis plan, including three interim analyses. For the primary analysis, we will use logistic regression adjusted for the stratification variables comparing the two interventions in the intention-to-treat (ITT) population.Discussion: The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock. [ABSTRACT FROM AUTHOR]

The use of pressure‐offloading support surfaces is considered the standard of care for pressure ulcers (PUs) by most surgeons. The fluid immersion simulation system (FIS) has shown significant results in previous studies. We compared it, for the first time, with a representative air‐fluidised bed (AFB) for outcomes related to post‐surgical flap closures. This trial was performed over 25 months, in which 40 subjects between 18 and 85 years of age with ≤2 PUs and history of <3 surgical closures underwent reconstruction by one surgeon. Subjects were randomly assigned to either treatment group for 2 weeks after closure. The primary endpoint was success of closure after the study period. Secondary endpoints included incidence of complications and nursing and patient acceptability of the device. The FIS group included 19 subjects, and the AFB group included 21. Flap failure rate was similar between groups (15% vs 17%; P = .99). The Minor complications rate, particularly dehiscence, was higher in the FIS group (66.7% vs 15%; P = .02). Nurse and patient self‐reported acceptability had better mean numeric scores in the FIS compared with AFB (nurse: 1.5 vs 1.9; P = .12; patient: 1.9 vs 2.2; P = .14). Further analysis will be conducted to gain better insight on the FIS as an alternative treatment for PUs. [ABSTRACT FROM AUTHOR]

Objective: To measure the impact of a 6‐month home‐based behaviour change intervention on reducing the risk of chronic disease as determined by metabolic syndrome status and cardiovascular risk score, and discuss implications for primary care in rural areas. Design: A two‐arm randomised controlled trial of rural adults. Setting: The rural town of Albany in the Great Southern region of Western Australia. Participants: Participants (n = 401) aged 50‐69 years who were classified with or at risk of metabolic syndrome and randomly assigned to intervention (n = 201) or waitlisted control (n = 200) group. Interventions: A 6‐month intervention program incorporating goal setting, self‐monitoring and feedback, with motivational interviewing was conducted. Main outcome measures: Change in metabolic syndrome status and cardiovascular risk. Results: Significant improvements in metabolic syndrome status and cardiovascular disease risk score (−0.82) were observed for the intervention group relative to control group from baseline to post‐test. Conclusion: This home‐based physical activity and nutrition intervention reduced participants' risk of experiencing a cardiovascular event in the next 5 years by 1%. Incorporating such prevention orientated approaches in primary care might assist in reducing the burden of long‐term chronic diseases. However, for realistic application in this setting, hurdles such as current national health billing system and availability of resources will need to be considered. [ABSTRACT FROM AUTHOR]

Background: Effortful swallowing training (EST) is a remedial method for the training of swallowing‐related muscles in the oropharyngeal phase. However, clinical evidence of its effectiveness is insufficient. Aims: To investigate the effects of EST on tongue strength and swallowing function in patients with stroke. Methods & Procedures: Stroke patients with dysphagia were randomly assigned to one of two groups: an experimental group (n = 12) and a control group (n = 12). The experimental group underwent EST, while the control group performed saliva swallowing. Training was conducted 5 days per week for 4 weeks. Both groups underwent conventional dysphagia treatment for 30 min/day, 5 days/week for 4 weeks. Outcomes & Results: Tongue strength was assessed using the Iowa Oral Performance Instrument. The Videofluoroscopic Dysphagia Scale (VDS), based on a videofluoroscopic swallowing study, was used to analyze oropharyngeal swallowing function. The experimental group showed greater improvements in anterior and posterior tongue strength compared with the control group (p = 0.046 and 0.042, respectively), and greater improvement in the oral phases of the VDS (p = 0.017). Conclusions & Implications: We recommend EST as a remedial strategy for improving tongue strength and oral swallowing function in patients with stroke. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives: The potential bias introduced by surgeons' lack of comparable, relevant experience when performing the procedures in different arms of randomized controlled trials (RCTs) is arguably not well‐managed or reported. The aim of this work was to review the frequency and nature with which surgeons' relevant experience is reported in RCTs of total hip (THA) and total knee arthroplasty (TKA), and to relate this to other risk of bias domains for this study design. Methods: A systematic review of RCTs comparing different minimally invasive procedures for TKA and comparisons of THA and hemiarthroplasty (HA). We searched MEDLINE, EMBASE, Science Citation Index, The Cochrane Library, Conference Proceedings Citation Index‐Science (CPCI‐S), Current Controlled Trials, and Clinical Trials.gov. Results: Seventy‐five relevant RCTs were identified, 65 RCTs comparing minimally invasive with standard or other minimally invasive approaches to TKA, and 10 for THA compared with HA. Risk of bias based on the reported details of surgeons' relevant experience was categorized as low, high, or unclear. There was a clear distinction before and after 2009, with a substantial decrease in trials at high or unclear risk of bias after this date. There were no strong associations between this domain and other, standard risk of bias domains for RCTs. Conclusion: The surgeons' relevant experience in an evaluated procedure is often poorly reported but has improved since 2009. The variable is not adequately captured by any other risk of bias domain. Future work should concentrate on conducting research on a much larger sample of studies and in procedures other than knee and hip arthroplasty. [ABSTRACT FROM AUTHOR]

Background: Electropalatography (EPG) records details of the location and timing of tongue contacts with the hard palate during speech. It has been effective in treating articulation disorders that have failed to respond to conventional therapy approaches but, until now, its use with children and adolescents with intellectual/learning disabilities and speech disorders has been limited. Aims: To evaluate the usefulness of EPG in the treatment of speech production difficulties in children and adolescents with Down syndrome (DS) aged 8–18 years. Methods & Procedures: A total of 27 children with DS were assessed on a range of cognitive and speech and language measures and underwent additional EPG assessment. Participants were randomly allocated to one of three age‐matched groups receiving either EPG therapy, EPG‐informed conventional therapy or 'treatment as usual' over a 12‐week period. The speech of all children was assessed before therapy using the Diagnostic Evaluation of Articulation and Phonology (DEAP) and reassessed immediately post‐ and 3 and 6 months post‐intervention to measure percentage consonants correct (PCC). EPG recordings were made of the DEAP assessment items at all time points. Per cent intelligibility was also calculated using the Children's Speech Intelligibility Measure (CSIM). Outcomes & Results: Gains in accuracy of production immediately post‐therapy, as measured by PCC, were seen for all groups. Reassessment at 3 and 6 months post‐therapy revealed that those who had received therapy based directly on EPG visual feedback were more likely to maintain and improve on these gains compared with the other groups. Statistical testing showed significant differences between groups in DEAP scores across time points, although the majority did not survive post‐hoc evaluation. Intelligibility across time points, as measured by CSIM, was also highly variable within and between the three groups, but despite significant correlations between DEAP and CSIM at all time points, no statistically significant group differences emerged. Conclusions & Implications: EPG was an effective intervention tool for improving speech production in many participants. This may be because it capitalizes on the relative strength of visual over auditory processing in this client group. The findings would seem to warrant an increased focus on addressing speech production difficulties in current therapy. [ABSTRACT FROM AUTHOR]

The optimal frequency of tooth brushing in the critically ill has not been experimentally determined. For mechanically ventilated patients, optimal frequency of tooth brushing is an important unresolved issue as there is little evidence to judge the benefits or associated risks of tooth brushing. Given this knowledge gap, the project's overall goal is to determine the optimal frequency of tooth brushing (once, twice, or three times daily) for mechanically ventilated adults. A prospective, randomized, experimental design is used. Specifically, 345 subjects, with 207 expected to complete the study, are randomly assigned within 36 hr of intubation to one of three groups (once, twice, or three times tooth brushing daily). Tooth brushing with a soft compact‐head toothbrush takes approximately 2 min. Dental plaque assessment, gingival crevicular fluid (GCF) determination for IL‐1β, and data regarding healthcare‐acquired infection (HAI) and clinical status are collected at baseline and daily in‐hospital. The clinical impact of daily frequency of tooth brushing in relation to extent of dental plaque and inflammation reflected by GCF analysis will be compared by the three treatment arms. In addition, evaluation of safety for HAIs will be compared based on calculation of the number needed to harm. The trial will empirically determine the optimal frequency of tooth brushing in mechanically ventilated adults, balancing benefits and risks. This contribution is significant because it will have immediate impact on bedside nursing practice, and is a final component necessary for specific evidence‐based guidelines for the common nursing intervention of oral care in mechanically ventilated adults. [ABSTRACT FROM AUTHOR]

Abstract: Aspirin remains the standard for stroke prophylaxis. However, as many as 20%‐25% of patients may fail to show a full response to aspirin. Ideally, patients who are resistant to aspirin could be identified, then receive an increased dose of aspirin or be changed to an alternative therapy more efficiently. We have developed an in vitro assay that may make this possible. Healthy volunteers (n = 13) between 18 and 50 years of age were tested for both ex vivo and in vivo responses to aspirin. Dimethyl sulfoxide (DMSO) was selected as the solvent for aspirin in the assay. DMSO can exhibit antiplatelet effects, necessitating the use of a concentration low enough to avoid such antiplatelet effects. Blood samples were tested against DMSO 0%, 0.05%, 0.5%, and 1% w/v with and without aspirin 0, 50, and 100 μM. The effects of both agents were measured via whole‐blood aggregometry. A 3‐dimensional response model described the data well, quantifying the combinatorial effect of DMSO and aspirin on platelet aggregation. Across all participants, baseline aggregation stimulated with collagen 1 μM or arachidonate 0.5 mM was approximately 18 and 13 Ω, respectively. The response model showed that 0.05% DMSO with 100 μM aspirin would provide platelet aggregation of 3.4 Ω. A DMSO concentration of 0.05% in the absence of aspirin would result in no discernable effects on platelet aggregation (17.7 Ω). Overall, the use of 100 μM of aspirin in 0.05% DMSO provides a robust method to test for ex vivo inhibition of platelet aggregation. [ABSTRACT FROM AUTHOR]

Abstract: Pregnant and post‐partum women require increased nutrient intake and optimal cognition, which depends on adequate nutrition, to enable reasoning and learning for caregiving. We aimed to assess (a) differences in maternal cognition and caregiving between women in Malawi who received different nutritional supplements, (b) 14 effect modifiers, and (c) associations of cognition and caregiving with biomarkers of iron, Vitamin A, B‐vitamin, and fatty acid status. In a randomized controlled trial (n = 869), pregnant women daily received either multiple micronutrients (MMN), 20 g/day lipid‐based nutrient supplements (LNS), or a control iron/folic acid (IFA) tablet. After delivery, supplementation continued in the MMN and LNS arms, and the IFA control group received placebo until 6 months post‐partum, when cognition (n = 712), caregiving behaviour (n = 669), and biomarkers of nutritional status (n = 283) were assessed. In the full group, only one difference was significant: the IFA arm scored 0.22 SD (95% CI [0.01, 0.39], p = .03) higher than the LNS arm in mental rotation. Among subgroups of women with baseline low hemoglobin, poor iron status, or malaria, those who received LNS scored 0.4 to 0.7 SD higher than the IFA arm in verbal fluency. Breastmilk docosahexaenoic acid and Vitamin B12 concentrations were positively associated with verbal fluency and digit span forward (adjusting for covariates ps < .05). In this population in Malawi, maternal supplementation with MMN or LNS did not positively affect maternal cognition or caregiving. Maternal docosahexaenoic acid and B12 status may be important for post‐partum attention and executive function. [ABSTRACT FROM AUTHOR]

Aim: The 5:2 diet (two non‐consecutive days of 2460 KJ (600 calories) and 5 days of ad libitum eating per week) is becoming increasingly popular. This pilot study aimed to determine whether the 5:2 diet can achieve ≥5% weight loss and greater improvements in weight and biochemical markers than a standard energy‐restricted diet (SERD) in obese male war veterans. Methods: A total of 24 participants were randomised to consume either the 5:2 diet or a SERD (2050 KJ (500 calorie) reduction per day) for 6 months. Weight, waist circumference (WC), fasting blood glucose, blood lipids, blood pressure and dietary intake were measured at baseline, 3 and 6 months by a blinded investigator. Results: After 6 months, participants in both groups significantly reduced body weight (P = <0.001), WC (P = <0.001) and systolic blood pressure (P = 0.001). Mean weight loss was 5.3 ± 3.0 kg (5.5 ± 3.2%) for the 5:2 group and 5.5 ± 4.3 kg (5.4 ± 4.2%) for the SERD group. Mean WC reduction for the 5:2 group was 8.0 ± 4.5 and 6.4 ± 5.8 cm for the SERD group. There was no significant difference in the amount of weight loss or WC reduction between diet groups. There was no significant change in diastolic blood pressure, fasting blood glucose or blood lipids in either dietary group. Conclusions: Results suggest that the 5:2 diet is a successful but not superior weight loss approach in male war veterans when compared to a SERD. Future research is needed to determine the long‐term effectiveness of the 5:2 diet and its effectiveness in other population groups. [ABSTRACT FROM AUTHOR]

Adding amylase to fortified blended foods can improve energy density, and increase child's energy and nutrient intake. The efficacy of this strategy is unknown for the World Food Programme's Super Cereal Plus (SC+) and Super Cereal (SC) blends. The primary goal of this study was to investigate the increased energy intake from amylase-containing SC+ and SC compared to control porridges in Burkinabe children. Secondly, energy intake from amylase-containing porridges compared to CERELAC®, Vitazom, and eeZeeBAR™ was studied. Thirdly, caregivers' ( n = 100) porridge acceptability was investigated. The design was a randomized double-blind controlled cross-over trial studying the effect of amylase addition to SC+ and SC flours on porridge energy and nutrient intake in healthy Burkinabe children aged 12-23 ( n = 80) and 24-35 months ( n = 40). Amylase added to porridges increased energy density from 0.68 to 1.16 kcal/g for SC+ and from 0.66 to 1.03 kcal/g for SC porridges. Among children aged 12-23 months, mean energy intake from all porridges with amylase (135-164 kcal/meal) was significantly higher compared to control SC+ porridges (84-98 kcal/meal; model-based average). Among children aged 24-35 months, mean energy intakes were also significantly higher from all porridges with amylase added (245-288 kcal/meal) compared to control SC porridges (175-183 kcal/meal). Acceptability of the porridges among caregivers was rated neutral to good, both for amylase-added and non-amylase-containing porridges. These findings suggest that, among 12-35-month-old, adding amylase to fortified blended foods significantly increased energy and consequently nutrient intake per meal by 67% for SC+ and 47% for SC. Moreover, amylase-containing porridges were well accepted by the caregivers. [ABSTRACT FROM AUTHOR]

Objective To compare the effect of two newly formulated chlorhexidine ( CHX) and cetylpyridinium chloride ( CPC) mouthrinses after scaling and root planing ( SRP) in terms of clinical, microbiological, patient-based variables and adverse events, with a positive control with the same active components, already marketed and tested. Methods A pilot, randomized clinical trial, double-blind, parallel design with 1-month follow-up was conducted. Chronic periodontitis patients requiring non-surgical periodontal therapy were enrolled and randomly assigned to: (i) SRP and test-1 (new reformulation: 0.12% CHX and 0.05% CPC); (ii) SRP and test-2 (new formulation: 0.03% CHX and 0.05% CPC); or (iii) SRP and positive control (commercial product: 0.12% CHX and 0.05% CPC). All variables were evaluated at baseline and 1 month after SRP. Quantitative variables were compared by means of anova or Kruskal-Wallis test and qualitative variables by chi-square or McNemar tests. Results Thirty patients (10 per group) were included. After 1 month, there were significant differences among groups in plaque levels ( P = 0.016) as test-1 showed less sites with plaque than test-2 (31.15% [standard error- SE 2.21%] versus 49.39% [ SE 4.60%), respectively). No significant differences were found for global patient perception of the product or in adverse effects. Test groups showed better results in levels and proportions ( P = 0.022) of Capnocytophaga spp. Conclusions Within the limitations of this pilot study, it can be concluded that the newly formulated 0.12% CHX and 0.05% CPC mouthrinse showed larger plaque level reductions, without showing more adverse effects, when compared to the other two mouthrinses, after SRP. [ABSTRACT FROM AUTHOR]

Objective The aim was to evaluate the effect of a chlorhexidine-containing brush-on gel when used as supplement to oral hygiene instructions and mechanical debridement, on peri-implant mucositis in adults. Materials and methods The study group consisted of 38 adults (48-87 years.) with peri-implant mucositis that were consecutively enrolled in three private clinics after informed consent. The study employed a double-blind controlled design with two parallel arms. After baseline registrations, oral hygiene reinforcement and mechanical debridement, the patients were randomly allocated to either a test group with once daily tooth brushing with an oral care brush-on gel containing 0.2% chlorhexidine digluconate (Cervitec Gel) or a control gel group. The duration of the intervention was 12 weeks. The primary outcome was bleeding on probing ( BOP) and secondary endpoints were local plaque score ( LPS) and pocket probing depth ( PPD). Results The groups were balanced at baseline. The daily use of the chlorhexidine-containing gel resulted in reduced BOP after 4 and 12 weeks compared with the control group ( P < 0.05). The PPD was significantly reduced ( P < 0.05) after 12 weeks compared to baseline in the test group, but not in the control group. No side effects or adverse events were reported. Conclusion The present findings indicated moderate but significant improvements of clinical parameters when mechanical debridement was combined with a self-applied oral care brush-on gel for the management of peri-implant mucositis. [ABSTRACT FROM AUTHOR]

Prenatal supplementation with protein-energy (PE) and/or multiple-micronutrients (MMNs) may improve fetal growth, but trials of lipid-based nutritional supplements (LNSs) have reported inconsistent results. We conducted a post-hoc analysis of non-primary outcomes in a trial in Gambia, with the aim to test the associations of LNS with fetal growth and explore how efficacy varies depending on nutritional status. The sample comprised 620 pregnant women in an individually randomized, partially blinded trial with four arms: (a) iron and folic acid (FeFol) tablet (usual care, referent group), (b) MMN tablet, (c) PE LNS, and (d) PE + MMN LNS. Analysis of variance examined unadjusted differences in fetal biometry z-scores at 20 and 30 weeks and neonatal anthropometry z-scores, while regression tested for modification of intervention-outcome associations by season and maternal height, body mass index, and weight gain. Despite evidence of between-arm differences in some fetal biometry, z-scores at birth were not greater in the intervention arms than the FeFol arm (e.g., birth weight z-scores: FeFol −0.71, MMN −0.63, PE −0.64, PE + MMN −0.62; group-wise p = .796). In regression analyses, intervention associations with birth weight and head circumference were modified by maternal weight gain between booking and 30 weeks gestation (e.g., PE + MMN associations with birth weight were +0.462 z-scores (95% CI [0.097, 0.826]) in the highest quartile of weight gain but -0.099 z-scores (−0.459, 0.260) in the lowest). In conclusion, we found no strong evidence that a prenatal LNS intervention was associated with better fetal growth in the whole sample. [ABSTRACT FROM AUTHOR]

Objectives The study was performed to evaluate the incidence of post-surgical adverse events at submerged implant sites as well as the antiplaque, antigingivitis and antistaining effects in the entire dentition of patients treated with two mouthwashes. Methods The present randomized controlled clinical study considered 40 patients subjected to dental implant treatment. Two 0.12% chlorhexidine mouthwashes were compared for 15 days: one with 0.1% hyaluronic acid ( CHX⊗ HYL group) and one without it ( CHX group). Surgical outcome variables, and plaque, gingival, and staining indexes were recorded. Results Significant differences were found between the two rinses regarding the presence of oedema within 2 days after surgery (20% for the CHX⊗ HYL group and 78% for the CHX group). No other significant differences were recorded between the two mouthwashes. No intergroup differences in plaque, staining and gingivitis indexes were registered. The intragroup analysis revealed that for the plaque and gingival indexes, the differences between the baseline values (before surgery) and those at 15 days were all found to be significant just for CHX⊗ HYL rinse, with final values ranging from 0.18 to 0.23 for the plaque index and from 0.06 to 0.07 for the gingival index. The staining index increased for both mouthwash types with significant results (with final value of 0.19 and 0.31 for CHX⊗ HYL and CHX groups, respectively). Conclusions In the sites of patients subjected to dental implant placement, an additional anti-oedematigenous effect in early healing seemed to be disclosed for 0.12% CHX⊗ HYL mouthwash. Regarding antiplaque and antigingivitis activities, HYL seemed to be ineffective. [ABSTRACT FROM AUTHOR]

Background In healthy individuals, the absorption of fructose in excess of glucose in solution is enhanced by the addition of glucose. The present study aimed to assess the effects of glucose addition to fructose or fructans on absorption patterns and genesis of gastrointestinal symptoms in patients with functional bowel disorders. Methods Randomised, blinded, cross-over studies were performed in healthy subjects and functional bowel disorder patients with fructose malabsorption. The area-under-the-curve ( AUC) was determined for breath hydrogen and symptom responses to: (i) six sugar solutions (fructose in solution) (glucose; sucrose; fructose; fructose + glucose; fructan; fructan + glucose) and (ii) whole foods (fructose in foods) containing fructose in excess of glucose given with and without additional glucose. Intake of fermentable short chain carbohydrates ( FODMAPs; fermentable, oligo-, di-, monosaccharides and polyols) was controlled. Results For the fructose in solution study, in 26 patients with functional bowel disorders, breath hydrogen was reduced after glucose was added to fructose compared to fructose alone [mean (SD) AUC 92 (107) versus 859 (980) ppm 4 h-1, respectively; P = 0.034). Glucose had no effect on breath hydrogen response to fructans ( P = 1.000). The six healthy controls showed breath hydrogen patterns similar to those with functional bowel disorders. No differences in symptoms were experienced with the addition of glucose, except more nausea when glucose was added to fructose ( P = 0.049). In the fructose in foods study, glucose addition to whole foods containing fructose in excess of glucose in nine patients with functional bowel disorders and nine healthy controls had no significant effect on breath hydrogen production or symptom response. Conclusions The absence of a favourable response on symptoms does not support the concomitant intake of glucose with foods high in either fructose or fructans in patients with functional bowel disorders. [ABSTRACT FROM AUTHOR]

Background and Objective Triclosan/copolymer toothpaste is effective in controlling plaque and gingivitis and in slowing the progression of periodontitis. This study describes its influence on microbiological and clinical outcomes, over a 5-year period, in patients with established cardiovascular disease ( CVD). Material and Methods Four-hundred and thirty-eight patients were recruited from the Cardiovascular Unit at The Prince Charles Hospital, Brisbane, Australia, and randomized to triclosan or placebo groups. Six sites per tooth were examined annually for probing pocket depth and loss of attachment. These outcomes were analysed, using generalized linear modelling, in 381 patients who had measurements from consecutive examinations. Concurrent load of the periodontal pathogens Aggregatibacter actinomycetemcomitans, Fusobacterium nucleatum, Tannerella forsythia and Porphyromonas gingivalis was determined, using quantitative real-time PCR, in 437 patients with baseline plaque samples. Group comparisons were expressed as geometric means. The chi-square test was used to test for differences between the two groups of patients with regard to the proportion of patients with different numbers of bacterial species. Results There was no difference in general health or periodontal status between the groups at baseline. There was a significant reduction in the number of interproximal sites showing loss of attachment between examinations, by 21% on average ( p < 0.01), in the triclosan group compared with the placebo group. The prevalence of patients with F. nucleatum and A. actinomycetemcomitans was high and remained relatively constant throughout the 5 years of the study. In contrast, the prevalence of T. forsythia and P. gingivalis showed more variability; however, there was no significant difference between the groups, at any time point, in the prevalence of any organism. A significant difference in the geometric means for P. gingivalis ( p = 0.01) was seen at years 1 and 4, and for F. nucleatum ( p = 0.01) and in the total bacterial load ( p = 0.03) at year 2; however, these differences were not statistically significant following a Bonferroni correction for multiple comparisons. There was no difference between the groups in the geometric means for each organism at year 5. Conclusion Within the limitations of the study, these data suggest that the use of triclosan/copolymer toothpaste significantly slowed the progression of periodontitis in patients with CVD but that it had little influence on key subgingival periodontopathic bacteria in these patients over the 5 years of the study. [ABSTRACT FROM AUTHOR]