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Background Studies: Captioning and repetition are widely used multimedia instructional devices for non‐native students. Generally, studies in this area have tended to focus on second language literacy skills rather than on learning new content knowledge. Additionally, posttests were administered immediately after the treatments, while the delayed influences of captioning and repetition have never been investigated. Objectives: This paper addressed these research gaps in two separate studies. More specifically, this study attempted to examine the influences of captioning and repetition on non‐native students' immediate and relayed retention. Methods: In Study One, three captioning conditions; word‐by‐word captions, closed captions, and no‐captions; were compared to examine their efficacies in immediate and delayed content knowledge retention on 82 Chinese university students. To address the limitations in Study One as the multimedia lesson was short and played only once, Study Two incorporated captioning and two repetition types in its design. One hundred and eleven Chinese university students watch a video lesson in one of four captioning and repetition conditions. Results: The statistical analyses of Study One indicated that there were no significant differences in both immediate and delayed retention test scores across the three captioning condition. Similarly, in Study Two, there were no significant differences in retention tests scores across the four captioning and repetition conditions. Findings: Neither the availability of captions nor the repetition types had any impact on the Chinese students' immediate or delayed content knowledge retention, which lent support to existing studies. Based on the research results, the limitations and future study possibilities are discussed. Lay Description: What Is Already Known About This TopicEmpirical studies on captioning have focused on immediate learning right after the treatment, so have studies on repetition.Empirical studies on multimedia lessons for non‐native students have focused on English language learning. What This Paper AddsThree types of captioning were compared to examine their efficacies in both immediate and delayed content retention of Chinese students.Two types of repetition were compared to examine their efficacies in both immediate and delayed content retention of Chinese students. Implications for Practice and/or Policy:Neither the availability of captions nor the repetition types had any impact on the Chinese students' immediate or delayed content knowledge retention.The availability of textual keywords adjacent to their corresponding graphics might have compromised the efficacy of captioning. [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]

Rationale, aims and objectives Open-label extension (OLE) studies following blinded randomized controlled trials (RCTs) of pharmaceuticals are increasingly being carried out but do not conform to regulatory standards and questions surround the validity of their evidence. OLE studies are usually discussed as a homogenous group, yet substantial differences in study design still meet the definition of an OLE. We describe published papers reporting OLE studies focussing on stated objectives, design, conduct and reporting. Method A search of Embase and Medline databases for 1996 to July 2008 revealed 268 papers reporting OLE studies that met our eligibility criteria. A random sample of 50 was selected for detailed review. Results Over 80% of the studies had efficacy stated as an objective. The most common methods of allocation at the start of the OLE were for all RCT participants to switch to one active treatment or for only participants on the new drug to continue, but in three studies all participants were re-randomized at the start of the OLE. Eligibility criteria and other selection factors resulted in on average of 74% of participants in the preceding RCT(s) enrolling in the OLE and only 57% completed it. Conclusions Published OLE studies do not form a homogenous group with respect to design or retention of participants, and thus the validity of evidence from an OLE should be judged on an individual basis. The term 'open label' suggests bias through lack of blinding, but slippage in relation to the sample randomized in the preceding RCT may be the more important threat to validity. [ABSTRACT FROM AUTHOR]

OBJECTIVES This study aimed to investigate the relationship between the authenticity of instructional formats and outcome measures within a pre-clerkship clinical reasoning course. METHODS We conducted a randomised, prospective, crossover study with Year 2 medical students taking a pre-clerkship clinical reasoning course. Students were randomised to small groups and exposed to three formats of differing instructional authenticity (paper case, DVD presentation, standardised patient [SP] presentation) across three subject areas (abdominal pain, anaemia, polyuria). Three student cohorts were taught using one instructional format per subject area so that each cohort received a different instructional format for each of the three subject areas. Outcome measures (objective structured clinical examination, video quiz, written examination) were selected to determine the effect of each instructional format on the clinical reasoning of students. RESULTS Increasingly authentic instructional formats did not significantly improve clinical reasoning performance across all outcome measures and subject areas. However, the results of the video quiz showed significant differences in the anaemia subject area between students who had been instructed using the paper case and live SP-based formats (scores of 47.4 and 57.6, respectively; p = 0.01) and in the abdominal pain subject area, in which students instructed using the DVD format scored higher than students instructed using either the paper case or SP-based formats (scores of 41.6, 34.9 and 31.2, respectively; p = 0.002). CONCLUSIONS Increasing the authenticity of instructional formats does not appear to significantly improve clinical reasoning performance in a pre-clerkship course. Medical educators should balance increases in authenticity with factors such as cognitive load, subject area and learner experience when designing new instructional formats. [ABSTRACT FROM AUTHOR]

Objectives: This paper reports on the effect of 6‐month dental home visits compared to no dental home visits on 24‐month caries incidence in 5‐ to 6‐year‐olds. Methods: 5‐ to 6‐year‐olds attending kindergartens were randomized to receive either 6‐month dental home visits and education leaflets (Intervention group) or education leaflets alone (Control group) over 24 months. To detect a 15% difference in caries incidence with a significance level of 5% and power of 80%, 88 children were calculated to be needed in the Intervention group and 88 in the Control. Baseline clinical data included oral examinations at the kindergartens. Follow‐up visits were made on the 6th, 12th and 18th month. At the end of the 24 months, both the Intervention and Control groups were visited for oral examinations. The primary outcome was caries incidence, measured by the number and proportion of children who developed new caries in the primary molars after 24 months. The secondary outcome was the number of primary molars that developed new caries (d‐pms). Frequency distributions of participants by baseline socio‐demographic characteristics and caries experience were calculated. The chi‐square test was used to test differences between the caries experience in the Intervention and Control groups. The t test was used to compare the mean number of primary molars developing new caries between the Intervention Group and the Control Group. The number of children needed to treat (NNT) was also calculated. Results: At the 24‐month follow‐up, 19 (14.4%) developed new caries in the Intervention Group, compared to 60 (60.0%) in the Control Group (p =.001). On average, 0.2 (95% CI = 0.1–0.3) tooth per child in the Intervention Group was observed to have developed new caries compared to 1.1 (95% CI = 0.8–1.3) tooth per child in the Control Group (p =.001). The number of children needed to treat (NNT) to prevent one child from developing new caries was 2.2. Conclusions: The present study has demonstrated that 6‐month home visits to families of 5‐ to 6‐year‐olds are effective in caries prevention in 5‐ to 6‐year‐olds of low‐income families in a middle‐income country where access to health services, including oral health promotion services, is limited. [ABSTRACT FROM AUTHOR]

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

As immersive virtual reality (IVR) systems proliferate in classrooms, it is important to understand how they affect learning outcomes and the underlying affective and cognitive processes that may cause these outcomes. Proponents argue that IVR could improve learning by increasing positive affective and cognitive processing, thereby supporting improved performance on tests of learning outcome, whereas opponents of IVR contend that it could hurt learning by increasing distraction, thereby disrupting cognitive learning processes and leading to poorer learning outcomes. In a media comparison study, students viewed a biology lesson either as an interactive animated journey in IVR or as a slideshow on a desktop monitor. Those who viewed the IVR lesson performed significantly worse on transfer tests, reported higher emotional arousal, reported more extraneous cognitive load and showed less engagement based on EEG measures than those who viewed the slideshow lesson, with or without practice questions added to the lessons. Mediational analyses showed that the lower retention scores for the IVR lesson were related to an increase in self‐reported extraneous cognitive load and emotional arousal. These results support the notion that immersive environments create high affective and cognitive distraction, which leads to poorer learning outcomes than desktop environments. Lay Description: What is already known about the topic: IVR is gaining popularity in classrooms, and it is important to understand its effects on learning.Some theories suggest IVR could help learning because it may increase motivation.Other theories suggest IVR could hurt learning because it causes distraction. What this paper adds: The biology lesson displayed in IVR led to less learning than a PowerPoint lesson.Viewing the IVR lesson caused higher emotional arousal than viewing the PowerPoint lesson.The IVR lesson led to more distraction based on self‐report and EEG measures than the PowerPoint lesson.These results suggest that IVR creates high emotional and cognitive distraction, which leads to less learning. Implications for practice: Using IVR to replace traditional classroom lessons may not yet be useful.However, because students report enjoying IVR, it may be useful to use in addition to conventional lessons.Future research should determine how specific factors of the technology and the learners affect learning outcomes. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to see if a more sophisticated ventilator hyperinflation protocol might result in more sputum clearance compared to manual hyperinflation. Background: Hyperinflation has been used to mobilize lung secretions in mechanically ventilated patients in the intensive care unit setting for almost 50 years. In the past decade, rather than using a bag external to the ventilator circuit to deliver hyperinflation (known as "bagging" or "manual hyperinflation"), a new technique has evolved using existing ventilator circuitry (known as "ventilator hyperinflation"). One conservative ventilator hyperinflation protocol has demonstrated equivalence with manual hyperinflation in sputum clearance. Design A randomized crossover study. Method: Patients received manual hyperinflation and ventilator hyperinflation in two randomly ordered treatments on the same day by the same physiotherapist, using a ventilator hyperinflation protocol involving titration of hyperinflation according to airway pressure. Results: Between 2013 and 2018, 48 patients were enrolled in the study. Physiotherapy treatment using ventilator hyperinflation yielded significantly more wet weight sputum (median 2.84 g, IQR 1.81, 4.22) than treatment using manual hyperinflation (median 1.5 g, IQR 0.73, 2.31, P <.001), without significant differences in secondary measures. Conclusions: A more sophisticated approach to the titration of the volume delivered using ventilator hyperinflation relative to the airway pressure resulted in greater wet weight sputum cleared during physiotherapy treatment. Relevance to Clinical Practice: The results presented in this paper demonstrate that the application of ventilator hyperinflation using peak airway pressure rather than tidal volume may be superior in facilitating sputum clearance and improved oxygenation without patient harm. [ABSTRACT FROM AUTHOR]

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

Abstract: Breastfeeding is challenging for mothers of preterm infants. The aim of this paper is to describe risk factors for ceasing breastfeeding and methods of feeding until 12 months postnatal age in mothers who breastfed their preterm infants at discharge from neonatal intensive care units (NICUs). The data come from a randomised controlled trial, which evaluated the effectiveness on exclusive breastfeeding at 8 weeks of proactive telephone support compared with reactive support offered to mothers of preterm infants following discharge from NICU. Six NICUs across Sweden randomised a total of 493 mothers. We used regression and survival analyses to assess the risk factors for ceasing breastfeeding and the long‐term outcomes of the intervention. The results showed that 305 (64%) of the infants were breastfed at 6 months and 49 (21%) at 12 months. Partial breastfeeding at discharge, low maternal educational level, and longer length of stay in the NICU increased the risk for ceasing breastfeeding during the first 12 months. Furthermore, the Kaplan–Meier analysis showed that the proportion of mothers who ceased breastfeeding did not differ between the intervention (n = 231) and controls (n = 262) during the first 12 months (log‐rank test p = .68). No difference was found between groups on method of feeding. More than 85% of the infants were fed directly at the breast. These findings provide important insights for health professionals who are supporting mothers of preterm infants to breastfeed long term. Registered in www.clinicaltrials.gov (NCT01806480). [ABSTRACT FROM AUTHOR]

Behaviour change communication (BCC) can improve infant and young child nutrition (IYCN) knowledge, practices, and health outcomes. However, few studies have examined whether the improved knowledge persists after BCC activities end. This paper assesses the effect of nutrition sensitive social protection interventions on IYCN knowledge in rural Bangladesh, both during and after intervention activities. We use data from two, 2-year, cluster randomised control trials that included nutrition BCC in some treatment arms. These data were collected at intervention baseline, midline, and endline, and 6-10 months after the intervention ended. We analyse data on IYCN knowledge from the same 2,341 women over these 4 survey rounds. We construct a number correct score on 18 IYCN knowledge questions and assess whether the impact of the BCC changes over time for the different treatment groups. Effects are estimated using ordinary least squares accounting for the clustered design of the study. There are 3 main findings: First, the BCC improves IYCN knowledge substantially in the 1st year of the intervention; participants correctly answer 3.0-3.2 more questions (36% more) compared to the non-BCC groups. Second, the increase in knowledge between the 1st and 2nd year was smaller, an additional 0.7-0.9 correct answers. Third, knowledge persists; there are no significant decreases in IYCN knowledge 6-10 months after nutrition BCC activities ended. [ABSTRACT FROM AUTHOR]

Responsive feeding serves as an important protective factor for infant growth and overall health development. This study based on self‐determination theory (SDT) aimed to assess the effects of a responsive breastfeeding (RBF) intervention programme on maternal breastfeeding and infant growth and development. A total of 110 mother–infant pairs were recruited and randomly divided into an intervention group (n = 55) and a control group (n = 55). The primary outcomes were breastfeeding motivation score, breastfeeding self‐efficacy (BSE) and exclusive breastfeeding rate; the secondary outcomes were infant physical development at 6 weeks and 3 months. A repeated measures ANOVA indicated that the intervention group had significantly higher Enjoyment scores compared to the control group at three time points: at discharge (MD: 5.28; 95% CI: 3.68 to 6.89; p < 0.001), 6 weeks post‐partum (MD: 5.06; 95% CI: 3.80 to 6.31; p < 0.001) and 3 months post‐partum (MD: 5.24; 95% CI: 4.12 to 6.35; p < 0.001). Similarly, the intervention group reported significantly higher connection and mother's self‐perception scores at discharge (MD: 4.31; 95% CI: 3.07 to 5.56; p < 0.001), 6 weeks post‐partum (MD: 4.69; 95% CI: 3.71 to 5.68; p < 0.001) and 3 months post‐partum (MD: 4.93; 95% CI: 4.14 to 5.72; p < 0.001), compared to the control group. In contrast, the pressure from significant others scores were higher in the control group relative to the intervention group at discharge (MD: −2.09; 95% CI: −2.88 to −1.31; p < 0.001), 6 weeks post‐partum (MD: −4.35; 95% CI: −5.20 to −3.49; p < 0.001) and 3 months (MD: −4.89; 95% CI: −5.70 to −4.08; p < 0.001). Finally, the intervention group also reported higher Instrumental Needs scores at all three time points: at discharge (MD: 1.96; 95% CI: 1.35 to 2.58; p < 0.001), 6 weeks post‐partum (MD: 3.58; 95% CI: 3.05 to 4.11; p < 0.001) and 3 months post‐partum (MD: 1.18; 95% CI: 0.68 to 1.69; p < 0.001). BSE scores were significantly higher in the intervention group compared to the control group at discharge (MD: 14.29; 95% CI: 10.38 to 18.21; p < 0.001), 6 weeks post‐partum (MD: 14.04; 95% CI: 11.05 to 17.02; p < 0.001) and 3 months post‐partum (MD: 6.80; 95% CI: 4.66 to 8.94; p < 0.001). The rates of exclusive breastfeeding were higher in the intervention group than in the control group at each stage of the intervention (p < 0.01). At 6 weeks post‐partum, the intervention group's infants showed slower weight (t = −0.90, p = 0.371) and length (t = −0.69, p = 0.495) growth compared to the control group, though not significantly. By 3 months post‐partum, there was a significant difference in both weight (t = −3.46, p = 0.001) and length (t = −2.95, p = 0.004) between the groups. The findings in this study suggest that the RBF intervention programme based on SDT may be effective in improving mothers' motivation to breastfeed, building breastfeeding self‐confidence and increasing the rate of exclusive breastfeeding. The effects of the intervention on infant physical development will need to be verified with longer follow‐up in future research. Key messages: This study validated the application of responsive breastfeeding (RBF) intervention during the exclusive breastfeeding phase of Chinese infants.The RBF intervention may help to increase mothers' level of autonomous motivation for breastfeeding, enhance breastfeeding self‐efficacy and increase exclusive breastfeedingrates. The intervention had no significant effect on the weight and length of 6 week old infants but significantly impacted 3monthold infants, with slower growth observed in the intervention group compared to the control group.Future intervention programmes shouldinclude extended follow‐up periods to investigate the long‐term effects of RBF on infant growth and development. [ABSTRACT FROM AUTHOR]

Background Central venous catheters (CVCs) facilitate the administration of intravenous drugs, fluids, blood products and parenteral nutrition to patients with either chronic disease or critical illness. Despite a pivotal role within medical management, a common complication associated with CVC use is occlusion of the CVC lumen(s). CVC occlusion can interrupt and cause serious delays in administration of treatment interventions. Objectives The primary objective of this review was to assess the efficacy and safety of different interventions used to restore patency of occluded CVC lumens, in adults and children. Search methods We identified trials by searching the Cochrane Central Register of Clinical Trials (CENTRAL) ( The Cochrane Library 2011, Issue 9); OvidSP MEDLINE (1950 to September 2011); OvidSP EMBASE (1980 to September 2011) and NHS Evidence CINAHL (1982 to September 2011). We also searched clinical trial registers, handsearched reference lists, contacted pharmaceutical companies and authors of publications that met the inclusion criteria to identify trials. Selection criteria We selected randomized controlled trials which investigated the efficacy of an intervention (chemical, surgical or drug) used to restore patency to an occluded CVC lumen, in either adults or children. Data collection and analysis Three authors independently assessed those studies that met the inclusion criteria for quality and extracted the relevant data using a standardized form. Main results No studies were found that investigated the efficacy and safety of either chemical or surgical interventions. Seven studies (eight papers) with a total of 632 participants were identified from the search. They investigated different comparisons, strengths of thrombolytic or anticoagulant drug interventions for treating CVC lumen occlusion thought to be caused by a thrombus. There was low quality evidence from a meta-analysis of two studies suggesting that urokinase (various strengths) was more effective than placebo for restoring patency to occluded CVC lumens in adults and children with underlying medical conditions (relative risk (RR) 2.09, 95% confidence interval (CI) 1.47 to 2.95), with a number needed to treat of 4 (95% CI 2 to 8). There was insufficient evidence to draw conclusions on the safety of urokinase. The overall quality of the evidence provided by these studies was low to very low due to one or more domains being assessed as either at 'unclear risk of bias' or 'high risk of bias'. Furthermore, the total number of participants in these studies was small and consequently may lead to spurious results. Authors' conclusions There is inadequate evidence to draw strong conclusions on the efficacy or safety of the drug interventions included in this review. There is some low quality evidence from a meta-analysis of two studies investigating urokinase (various strengths) and some very low evidence from two single studies investigating alteplase 2 mg/2 mL that suggest that these two drug interventions may be effective in treating withdrawal or total occlusion of CVC lumens caused by thrombosis. Further high quality, sufficiently powered research is still required to look at the efficacy and safety of urokinase, alteplase and other chemical, surgical and drug interventions for treating CVC lumen occlusion. Research studies which exclusively include child participants are especially warranted. Plain Language Summary Interventions for restoring patency of occluded central venous catheter lumens A central venous catheter is a small, hollow tube that is inserted into a large vein in either the chest, neck or groin. Central venous catheters enable healthcare professionals to administer drugs and other fluids directly into the blood stream, in order to treat critically ill patients or those patients with a long-term condition. In certain chronic conditions, patients or their carers may also be involved with the administration of treatment interventions via the central venous catheter. Occasionally, the catheter lumens can become blocked with either a blood clot or a treatment intervention solidifying in the tube, or due to the position of the tube inside the vein. If the catheter does become blocked it may mean that the patient has to undergo further surgery to remove and replace the blocked catheter. No studies were found investigating the efficacy and safety of surgical interventions (brush, snare or guidewire exchange) or chemical interventions (hydrochloric acid, sodium bicarbonate, 70% ethanol solution) to unblock the catheter. Our search identified seven studies (eight papers), with a total of 632 participants, that investigated different drug comparisons or compared different strengths of drug therapies for treating catheters that were either completely or partially blocked with a blood clot. This review has found low to very low quality evidence suggesting that thrombolytic drugs (urokinase and alteplase) could be effective in unblocking central venous catheter lumens blocked by blood clots. However, the total number of participants included in these trials was small and consequently the results of the analysis may well be over exaggerated. There were also issues with the way the studies were conducted that could possibly have introduced bias. In conclusion, more research is required to establish the efficacy and safety of different treatment interventions used to unblock occluded central venous catheter lumens. Particularly, there is a need for studies exclusively in children. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Clinical nurse specialists ( CNSs) are major providers of transitional care. This paper describes a systematic review of randomized controlled trials ( RCTs) evaluating the clinical effectiveness and cost-effectiveness of CNS transitional care. Methods We searched 10 electronic databases, 1980 to July 2013, and hand-searched reference lists and key journals for RCTs that evaluated health system outcomes of CNS transitional care. Study quality was assessed using the Cochrane Risk of Bias and Quality of Health Economic Studies tools. The quality of evidence for individual outcomes was assessed using the Grading of Recommendations Assessment, Development and Evaluation ( GRADE) tool. We pooled data for similar outcomes. Results Thirteen RCTs of CNS transitional care were identified ( n = 2463 participants). The studies had low ( n = 3), moderate ( n = 8) and high ( n = 2) risk of bias and weak economic analyses. Post-cancer surgery, CNS care was superior in reducing patient mortality. For patients with heart failure, CNS care delayed time to and reduced death or re-hospitalization, improved treatment adherence and patient satisfaction, and reduced costs and length of re-hospitalization stay. For elderly patients and caregivers, CNS care improved caregiver depression and reduced re-hospitalization, re-hospitalization length of stay and costs. For high-risk pregnant women and very low birthweight infants, CNS care improved infant immunization rates and maternal satisfaction with care and reduced maternal and infant length of hospital stay and costs. Conclusions There is low-quality evidence that CNS transitional care improves patient health outcomes, delays re-hospitalization and reduces hospital length of stay, re-hospitalization rates and costs. Further research incorporating robust economic evaluation is needed. [ABSTRACT FROM AUTHOR]

Background Although most people are aware of government guidelines for alcohol consumption, few have accurate knowledge of these and fewer still use these guidelines to monitor their drinking. Most people also lack accurate knowledge of the alcohol content of the drinks they consume. The aim of the study reported here was to examine whether or not personalized feedback on alcohol consumption based on performance in a drink-pouring task and self-reported alcohol intake would improve university students' knowledge of alcohol consumption guidelines and reduce their alcohol intake. Methods A quasi-randomized control trial with a 2-month follow-up was conducted with 200 students aged 18 to 37 in the south of England. Participants were allocated to a 'pour + feedback' group that completed a drink-pouring task and received personalized feedback, a 'pour only' group that completed the drink-pouring task but did not receive feedback, and a control group. Results At follow-up, participants in the 'pour + feedback' group had significantly better knowledge of government guidelines, and significantly lower weekly alcohol intake when compared to the 'control' and 'pour only' groups. Conclusions Further refinement of the drink-pouring intervention and feedback is reported in this paper, and assessment of their impact in various populations may lead to better understanding of which elements of personalized feedback have the greatest influence on young people's alcohol use. [ABSTRACT FROM AUTHOR]

Prenatal iron supplementation improves children's health and cognitive performance, but few studies explore behavioural development. This study assessed the effects of adjusting prenatal iron supplementation to maternal iron stores during early pregnancy on children's behavioural problems. Randomized controlled trial conducted in Tarragona (Spain) involving 230 nonanaemic pregnant women and their children after a 4‐year follow‐up. Based on haemoglobin (Hb) levels before gestational week (GW) 12, women receive different iron doses: those with Hb = 110–130 g/L were randomized to receive 80 or 40 mg/day and those with Hb > 130 g/L were randomized to receive 20 or 40 mg/day. Maternal iron stores at GW12 were classified using serum ferritin (SF) as low (SF < 15 µg/L), normal (SF = 15–65 µg/L), and normal‐high (SF > 65 µg/L). Children's behaviour was assessed by parents using the Child Behaviour Checklist for ages 1.5–5 years and the Behaviour Rating Inventory of Executive Function‐Preschool Version, and by teachers using the Teacher's Report Form for ages 1.5–5 years. Multivariable regression models were performed. Taking 80 mg/day of iron improved child behaviour when women had low iron stores but worsened it when mothers had normal–high iron stores, except for depressive and attention/hyperactivity problems. Taking 20 mg/day of iron improved behaviour only in those children whose mothers had SF > 65 µg/L in early pregnancy. Additionally, executive functioning improved at high doses of prenatal iron when maternal baseline SF < 15 µg/L. Adjusting prenatal iron supplementation to both maternal baseline Hb levels and iron stores reduces behavioural problems in 4‐year‐old children. Key messages: Prenatal iron supplementation succeeds in improving maternal haematological outcomes and cognitive performance of children, but few studies have focused on behavioural development.Prenatal iron supplementation adjusted to maternal iron stores reduces behavioural problems in 4‐year‐old children.Maternal iron stores early in pregnancy should be measured in addition to haemoglobin concentration.These findings contribute greatly to the advancement of public health by giving physicians the tools to prescribe the most appropriate dose of iron supplementation to contribute to better child development. [ABSTRACT FROM AUTHOR]

Background Late course accelerated hyperfractionation radiotherapy ( LCAHR) is used as a standard treatment option for locally advanced esophageal squamous cell carcinoma ( LAESCC) in China, but concerns remain regarding its efficacy and safety. The purpose of this paper was to evaluate the efficacy and safety of LCAHR. The comparisons examined were as follows: LCAHR versus conventional fractionation radiotherapy ( CFR) and LCAHR plus chemotherapy ( CT) versus LCAHR alone. Methods We searched the Cochrane Library, MEDLINE, EMBASE, CENTRAL, CBMdisc, and CNKI, as well as employing manual searches. The primary end points were survival and local control. The second end point was toxicities. Results Based on search criteria, we found 29 trials involving 3187 patients. Our results showed that LCAHR, compared with CFR, improved the survival and local control, and was, thus, more therapeutically beneficial. Further analysis revealed that LCAHR plus CT proved to be better for patients' survival and local control compared to LCAHR alone. Acute toxicities were increased rather than late toxicities. Conclusions There was a significant survival and local control benefit of LCAHR over CFR, as well as LCAHR plus CT over LCAHR alone. Considering the strength of the evidence, the results of this study indicate that this regimen would be a new promising modality worth further investigation. [ABSTRACT FROM AUTHOR]

Aims To update the existing scientific evidence on the efficacy of local antimicrobials as adjuncts to subgingival debridement in the treatment of chronic periodontitis. Material and Methods Fifty-six papers were selected, reporting data from 52 different investigations. All the studies reported changes in probing pocket depth ( PPD) and clinical attachment level ( CAL) and most in plaque index (PlI) and/or bleeding on probing ( BOP). Meta-analyses were performed with the data retrieved from the studies fulfilling the inclusion criteria. Results The overall effect of the subgingival application of antimicrobials was statistically significant ( p = 0.000) for both changes in PPD and CAL with a weighted mean difference ( WMD) of −0.407 and −0.310 mm respectively. No significant differences occurred for changes in BOP and PlI. Subgingival application of tetracycline fibres, sustained released doxycycline and minocycline demonstrated a significant benefit in PPD reduction ( WMD between 0.5 and 0.7 mm). The rest of the tested outcomes demonstrated a high heterogeneity. The local application of chlorhexidine and metronidazole showed a minimal effect when compared with placebo ( WMD between 0.1 and 0.4 mm). Conclusions The scientific evidence supports the adjunctive use of local antimicrobials to debridement in deep or recurrent periodontal sites, mostly when using vehicles with proven sustained release of the antimicrobial. [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]

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

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]

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

Background: Online exercise interventions can improve physical outcomes. Online supervised exercise program is more effective than unsupervised exercise program. Objectives: The aim of this study is to determine the effect of an online supervised exercise program on fasting blood glucose, body mass index (BMI), resilience and quality of life in older people with diabetes. Methods: This parallel group randomised controlled study included 70 older patients with Type 2 diabetes. Participants were divided into online supervised and unsupervised exercise training groups. Participants in the online‐supervised exercise group were given an online‐supervised exercise program 3 days a week for 6 weeks. Personal Information Form, Short Resilience Scale and Quality of Life Scale in Older People were used to collect data. In addition, fasting blood sugar BMI and values were measured. Results: According to the results of our study, while there was no significant difference between the pre‐and post‐training scores of the supervised and unsupervised groups on the Psychological Resilience Scale and Quality of Life Scale, it was observed that there was a significant difference in both groups according to time (p <.05). When the difference between the scores of the groups before and after the training was analysed according to time, a significant difference was observed between the online‐supervised and unsupervised exercise groups (p <.05). In addition, it was seen that there was a significant difference in the fasting blood sugar and BMI results of the online‐supervised exercise group according to time (p <.05). Conclusions: Online supervised exercise program decreases fasting blood sugar and BMI, increases psychological resilience and quality of life of older patients with Type 2 diabetes. Implication for practice: Online supervised exercise program may be an additional treatment that provides benefits for older people with diabetes who cannot participate in clinical‐based rehabilitation programs. [ABSTRACT FROM AUTHOR]

Aim: To examine the effects of breastfeeding support given by video call on anxiety, breastfeeding self‐efficacy, and newborn outcomes. Methods: We conducted a randomized controlled experimental trial with 72 women and their babies. Participants were randomly assigned to the intervention (video call) group (VCG: standard care + video call) and control group (CG: standard care). The primary outcomes of this study were the mean postpartum maternal anxiety level and the mean breastfeeding self‐efficacy level. The secondary outcome was neonatal outcomes. This study followed the CONSORT (Consolidated Standards of Reporting Trials) checklist. Results: Women in VCG had lower anxiety levels than the CG at postpartum 2 weeks (mean difference [MD] 25.42, p =.000) and 1 month (MD 47.72, p =.000). The breastfeeding self‐efficacy level of women in the VCG was higher than the CG at postpartum 2 weeks (MD 13.18, p =.007) and 1 month (MD 10.1, p =.001). The newborns in VCG had higher weight gain and daily breastfeeding frequency than the CG at the postpartum second week (MD 9.64, p =.001, MD 2.88, p =.000; respectively) and 1 month (MD 47.16, p =.000, MD 2.98, p =.000; respectively). There were lower rates of challenges of breastfeeding, hyperbilirubinemia, and feeding with formula in VCG than CG at the postpartum second week (p =.043, p =.043, p =.039; respectively). Conclusions: Breastfeeding support via video calling has positive effects on maternal anxiety, breastfeeding self‐efficacy, and newborn health. Postpartum caregivers may benefit from video calling for breastfeeding support. [ABSTRACT FROM AUTHOR]

Introduction: Australian and New Zealand accreditation standards for occupational therapy courses mandate consumer involvement in the design, delivery, and evaluation of courses. Consumer involvement in medical, dental, and nursing education has been evidenced as a factor for increasing student empathy. To date, there has been no known research on the impact of mental health consumer involvement on occupational therapy students' empathy. The aim of this study was to investigate if occupational therapy students who receive teaching from a mental health consumer demonstrate higher levels of empathy compared with students who receive teaching delivered by occupational therapy academics. Methods: Pre–post, quasi experimental, two group comparison design was used to measure second‐year student empathy pre and post a consumer‐led teaching tutorial. Students (N = 217) were randomised into two groups across three university campuses: 'teaching as usual group' (control) or 'consumer‐led' group (experimental group). The Jefferson Scale of Empathy was used to measure student empathy. Results: N = 138 matched scales were returned. Little difference in empathy scales was detected between groups. The 'consumer‐led' group increased for the empathy scale by 3.4(95% CI: 0.7,6.1, p = 0.014) but was not statistically significant compared to 1.3(95% CI: −1.0,3.5, p = 0.267) for the control group. Both groups scored highly on empathy. Conclusion: This study found that occupational therapy students had pre‐existing high levels of empathy. The challenge for future research is to identify appropriate ways to measure the impact of mental health consumer involvement on occupational therapy curriculum and students. [ABSTRACT FROM AUTHOR]

Aim: To compare postoperative pain intensity between two single‐file systems with different kinetics (the OneShape file with continuous rotation vs. the WaveOne Gold file with reciprocation movement) after primary molar pulpectomy. Design: This superiority, parallel, randomized clinical trial included 164 healthy children aged 6 to 8 years with asymptomatic, necrotic, maxillary primary second molars due to caries. An equal number of children were assigned to the two groups. The teeth of children in Group 1 were instrumented with the OneShape rotary system (Micro‐Mega), whereas teeth of children in Group 2 were instrumented with the WaveOne Gold reciprocating system (Dentsply Maillefer). Postoperative pain intensity was assessed using a 4‐point pain scale at 6, 12, 24, 48 and 72 h and 1 week after treatment. The parent of each participant received 6 flashcards that included four faces and a word describing each face. A chi‐square test was used to compare postoperative pain intensity. The level of significance was set to 5%. Results: Over the follow‐up period, no significant difference in postoperative pain intensity was found between the two groups (p >.05). Although the absolute risk reduction maximum limit of 95% CI equal or exceeded the predetermined proportional difference of 0.15, pain intensity was inconclusive at 6, 24, and 48 hours denoting that the superiority of the OneShape single‐file over the WaveOne Gold single‐file could not be declared. Conclusions: Postoperative pain intensity associated with a rotary vs. reciprocating file system was nearly similar. [ABSTRACT FROM AUTHOR]

Background: Blended learning, defined as the combination of traditional face‐to‐face instructor‐led learning and e‐learning course, has never been validated as a teaching method for the effective use of manual defibrillators in cardiopulmonary resuscitation. Aim: To evaluate whether paediatric emergency and critical care providers exposed to a blended learning session performed better and recalled more defibrillator skills than those exposed to face‐to‐face learning only. Study design: A two‐period prospective, stratified, single‐centre, simulation‐based, randomized, controlled trial. Methods: Registered nurses and postgraduate residents from either a paediatric emergency department or an intensive care unit were randomly assigned to a blended learning or face‐to‐face learning sessions on the recommended use of a manual defibrillator. Participants' adherence to recommendations was assessed by testing defibrillator skills in three consecutive paediatric cardiopulmonary scenarios performed on the day of the training and once again 2 months later. The primary endpoint was the number of errors observed during defibrillation, cardioversion, and transcutaneous pacing at the time of the initial intervention. Results: Fifty participants were randomized to receive the intervention and 51 to the control group. When pooling all three procedures, the median total errors per participant was lower (2 [IQR: 1‐4]) in providers exposed to blended learning than in those exposed to face‐to‐face learning only (3 [IQR: 2‐5]; P =.06). The median of total errors per procedure was also lower. However, both training methods appeared insufficient to maintain appropriate skill retention over time as a repetition of procedures 2 months later without any refresher learning session yielded more errors in both groups. Conclusions: Learners exposed to blended learning showed a reduced number in the total amount of errors compared with those exposed to face‐to‐face learning alone, with waning of skills over time. Relevance to clinical practice: Proficiently teaching the use of a manual defibrillator can be performed through blended learning. [ABSTRACT FROM AUTHOR]

People with diabetes frequently have elevated diabetes distress. Although mindfulness‐based stress reduction (MBSR) therapy has been shown effective in reducing diabetes distress, it has only been delivered by psychologists or a multidisciplinary team with an attrition rate of up to 39%, which limits its dissemination to a broader audience. This study was aimed to pilot evaluate the feasibility of a nurse‐led MBSR therapy and explore its potential efficacy amongst people with type 2 diabetes mellitus. A total of 100 participants were randomly allocated either to the intervention group (nurse‐led MBSR therapy + regular diabetes education) or the control group (regular diabetes education). Data on diabetes distress, diabetes self‐efficacy, and diabetes self‐management were collected at baseline, 8 and 12 weeks. Hemoglobin A1c (HbA1c) was collected at baseline and 12 weeks. A generalized estimating equation analysis for repeated measures was used to determine intervention and time effects. As predicted, the nurse‐led MBSR therapy had a significant time‐by‐group interaction effect on diabetes distress total score (95% confidence interval [CI]: 0.58–0.77, p < 0.001), diabetes self‐efficacy (95% CI: −0.93 to −0.74, p < 0.001), diabetes self‐management (95% CI: −10.80 to −7.83, p < 0.001), and HbA1c levels (95% CI: 0.04–1.14, p = 0.03) in the intervention group compared with the control group over 12 weeks. This is the first nurse‐led MBSR therapy in a hospital setting that is feasible and has the potential to improve health outcomes. This approach may offer an innovative model to deliver MBSR therapy. A randomized controlled trial comparing the nurse‐led MBSR plus usual diabetes education with usual diabetes education along with a mechanism to equalize intervention attention between the groups is indicated. [ABSTRACT FROM AUTHOR]

Purpose To assess the efficacy of petrolatum jelly for the prevention of diaper rash and to evaluate the relationship between the occurrence of diaper rash and certain treatments and type of nutrition. Design and Methods A randomized clinical trial was carried out with two parallel groups ( n = 213) at the neonatal care unit of Donostia University Hospital in San Sebastián, Guipuzcoa Province, Spain. Results There was a lower incidence of diaper rash in the experimental group with petrolatum jelly (17.1%) than the control group (22.2%), but the difference was not statistically significant ( p =.39). The use of antibiotics and oral 50% glucose as well as an increased number of stools are associated with a higher incidence of diaper rash, while breastfeeding and phototherapy are protective factors. Practice Implications Prevention is strengthened by a better understanding of the risk factors. [ABSTRACT FROM AUTHOR]

Child undernutrition in Cambodia is a persistent public health problem requiring low‐cost and scalable solutions. Rising cellphone use in low‐resource settings represents an opportunity to replace in‐person counselling visits with phone calls; however, questions remain on relative effectiveness. Our objective was to evaluate the impact of two options for delivering a World Vision infant and young child feeding (IYCF) counselling programme: (1) traditional Positive Deviance/Hearth (PDH) programme with in‐person visits or (2) PDH with Interactive Voice Calling (PDH‐IVC) which integrates phone calls to replace 62.5% of face‐to‐face interaction between caregivers and volunteers, compared to the standard of care (SOC). We conducted a longitudinal cluster‐randomised controlled trial in 361 children 6–23 months. We used an adjusted difference‐in‐difference approach using baseline, midline (3 months) and endline (12 months) surveys to evaluate the impact on child growth among the three groups. At baseline, nearly a third of children were underweight, and over half were food insecure. At midline the PDH group and the PDH‐IVC groups had improved weight‐for‐age z‐scores (0.13 DID, p = 0.011; 0.13 DID, p = 0.02, respectively) and weight‐for‐height z‐score (0.16 DID, p = 0.038; 0.24 DID, p = 0.002), relative to SOC. There were no differences in child height‐for‐age z‐scores. At endline, the impact was sustained only in the PDH‐IVC group for weight‐for‐age z‐score (0.14 DID, p = 0.049), and the prevalence of underweight declined by 12.8 percentage points (p = 0.036), relative to SOC. Integration of phone‐based IYCF counselling is a potentially promising solution to reduce the burden of in‐person visits; however, the modest improvements suggest the need to combine it with other strategies to improve child nutrition. [ABSTRACT FROM AUTHOR]

Maternal iodine (I) status is critical in embryonic and foetal development. We examined the effect of preconception iodine supplementation on maternal iodine status and on birth outcomes. Non‐pregnant women in Guatemala, India and Pakistan (n ~ 100 per arm per site) were randomized ≥ 3 months prior to conception to one of three intervention arms: a multimicronutrient‐fortified lipid‐based nutrient supplement containing 250‐μg I per day started immediately after randomization (Arm 1), the same supplement started at ~12 weeks gestation (Arm 2) and no intervention supplement (Arm 3). Urinary I (μg/L) to creatinine (mg/dl) ratios (I/Cr) were determined at 12 weeks for Arm 1 versus Arm 2 (before supplement started) and 34 weeks for all arms. Generalized linear models were used to assess the relationship of I/Cr with arm and with newborn anthropometry. At 12 weeks gestation, adjusted mean I/Cr (μg/g) for all sites combined was significantly higher for Arm 1 versus Arm 2: (203 [95% CI: 189, 217] vs. 163 [95% CI: 152, 175], p < 0.0001). Overall adjusted prevalence of I/Cr < 150 μg/g was also lower in Arm 1 versus Arm 2: 32% (95% CI: 26%, 38%) versus 43% (95% CI: 37%, 49%) (p = 0.0052). At 34 weeks, adjusted mean I/Cr for Arm 1 (235, 95% CI: 220, 252) and Arm 2 (254, 95% CI: 238, 272) did not differ significantly but were significantly higher than Arm 3 (200, 95% CI: 184, 218) (p < 0.0001). Nominally significant positive associations were observed between I/Cr at 12 weeks and birth length and head circumference z‐scores (p = 0.028 and p = 0.005, respectively). These findings support the importance of first trimester iodine status and suggest need for preconception supplementation beyond salt iodization alone. [ABSTRACT FROM AUTHOR]

Objective: This pilot study assessed the efficacy of personalised, printed and mobile‐accessible discharge instructions for pain relief for patients discharged from the ED. Methods: Patients presenting with pain caused by acute musculoskeletal or visceral complaints not requiring admission were eligible. Both groups received usual pain relief discharge advice, the intervention group received additional personalised printed and mobile‐accessible discharge instructions. Numerical Rating Scale pain scores were measured at ED visit. Pain scores, Patient Global Impression of Change scale improvement scores, satisfaction with instructions, recall of pain relief advice, receipt of side effects advice and unscheduled visits were measured at 5 days. Results: A total of 80 patients, recruited over 14 days, were randomly allocated to the intervention or control group. Two patients were excluded and 81% (n = 65) were followed up at 5 days. There was no significant difference in change of pain scores or improvement scores between groups from visit to 5 day follow up. The intervention group showed significantly higher odds of being 'very satisfied' compared to the control group (odds ratio [OR] 7.14, 95% confidence interval [CI] 1.18–50.00), significantly higher odds of full recall of pain relief medication advice (OR 20.00, 95% CI 1.56–100.00) and significantly higher odds of receiving information on medication side effects (OR 6.25, 95% CI 1.67–20.00). Conclusions: Patients who received personalised printed and mobile‐accessible ED discharge instructions for pain relief reported higher levels of satisfaction with their instructions, had better recall of their pain relief medications advice and received more information on medication side‐effects. [ABSTRACT FROM AUTHOR]

Aim: To examine whether adding the Community Reinforcement Approach for Seniors (CRA‐S) to Motivational Enhancement Therapy (MET) increases the probability of treatment success in people aged ≥ 60 years with alcohol use disorder (AUD). Design A single blind multi‐centre multi‐national randomized (1 : 1) controlled trial. Setting: Out‐patient settings (municipal alcohol treatment clinics in Denmark, specialized addiction care facilities in Germany and a primary care clinic in the United States). Participants: Between January 2014 and May 2016, 693 patients aged 60+ years and fulfilling DSM‐5 criteria for AUD participated in comparing MET (n = 351) and MET + CRA‐S (n = 342). Intervention and comparator: MET (comparator) included four manualized sessions aimed at increasing motivation to change and establishing a change plan. CRA‐S (intervention) consisted of up to eight further optional, manualized sessions aimed at helping patients to implement their change plan. CRA‐S included a specially designed module on coping with age and age‐related problems. Measurements The primary outcome was either total alcohol abstinence or an expected blood alcohol concentration of ≤ 0.05% during the 30 days preceding the 26 weeks follow‐up (defined as success) or blood alcohol concentration of > 0.05% during the follow‐up period (defined as failure). This was assessed by self‐report using the Form 90 instrument. The main analysis involved complete cases. Findings The follow‐up rate at 26 weeks was 76.2% (76.9% in the MET group and 76.0% in the MET + CRA‐S group). The success rate in the MET group was 48.9% [95% confidence interval (CI) = 42.9–54.9%] versus 52.3% (95% CI = 46.2–58.3%) in the MET + CRA‐S group. The odds of success in the two conditions did not differ (odds ratio = 1.22. 95% CI = 0.86–1.75, P = 0.26, Bayes factor = 0.10). Sensitivity analyses involving alternative approaches to missing values did not change the results. Conclusions: In older adults with an alcohol use disorder diagnosis, adding the 'community reinforcement approach for seniors' intervention to brief out‐patient motivational enhancement therapy treatment did not improve drinking outcome. [ABSTRACT FROM AUTHOR]

Objectives: To compare 3 mouthwashes: 0.20% chlorhexidine (CHX) with Anti‐Discoloration System (ADS), 0.20% CHX and 0.12% CHX with 0.05% cetylpyridinium chloride (CPC), in terms of reduction of plaque and gingival bleeding and side effects. Methods: Mild gingivitis patients were randomly divided into three Groups: they underwent professional oral hygiene and received instructions: oral rinse with 10 mL for 1', twice a day, 30' after tooth brushing, for 14 days. Primary outcomes were plaque and gingival bleeding, assessed with Plaque Control Record and Gingival Bleeding Index. Feedback questionnaire and spectrophotometer evaluated secondary outcomes: adverse events. Timing of the study was T0 (baseline), T1 (professional oral hygiene) and T2 (14th day after mouthwash use). Results: Sixty‐six patients were recruited, two patients dropped out, and 64 patients completed the study. PCR T1‐T2 mean variation was 30.67 (SD = 15.22; 95% CI 23.55 to 37.80; P = 0.000), 19.93 (SD = 11.03; 95% CI 14.90 to 24.95; P = 0.000) and 16.24 (SD = 15.35; 95% CI 9.60 to 22.88; P = 0.000) respectively in Groups 0.2% CHX + ADS, 0.2% CHX and 0.12% CHX + CPC. GBI mean variation (T0‐T2) was −9.82 (SD = 9.27; 95% CI −5.48 to 14.16; P = 0.000), −19.31 (SD = 11.33; 95% CI −14.15 to −24.47; P = 0.000) and −21.13 (SD = 12.56; 95% CI −15.70 to −26.56; P = 0.000) respectively in Groups 0.2% CHX + ADS, 0.2% CHX and 0.12% CHX + CPC. Statistical significance was found in lower efficacy of 0.2% CHX + ADS Group. Patients tolerated 0.12% CHX + CPC mouthwash better in bleeding perception (95.5%; P = 0.046), burning sensation (13.6%; P = 0.006), and mouthwash taste (100%; P = 0.000). Results on staining were no statistically significant (P = 0.106). Conclusions: Addition of CPC allows reduction of CHX percentage in mouthwash formulation while keeping equal efficacy and less side effects. ADS addition decreases CHX efficacy in reducing plaque and bleeding, while resulting more tolerated than CHX. [ABSTRACT FROM AUTHOR]

Background: Although language and communication difficulties are common in secondary school students, there has been limited research into the efficacy of interventions for adolescents with language and communication difficulties. Aims: To investigate the efficacy of teaching assistant (TA)‐delivered narrative and vocabulary interventions to mainstream secondary school‐aged students with language disorder. Methods & Procedures: A randomized controlled trial (RCT) of a language and communication intervention was used to evaluate the efficacy of vocabulary and narrative interventions to improve the vocabulary and narrative performance of adolescents (mean age = 12.8 years) with language disorder. The language and communication programmes (narrative, vocabulary and combined narrative and vocabulary) were delivered by TAs in the classroom, three times per week, for 45–60 min each, over 6 weeks, totalling 18 sessions. Standardized and intervention‐specific measures were used as outcomes. Outcomes & Results: Twenty‐one schools with 358 eligible participants were recruited. The three intervention groups showed significant improvements (d =.296) on a narrative latent variable defined by a standardized narrative assessment (the Expression, Reception and Recall of Narrative Instrument—ERRNI), but there were no significant improvements on an overall vocabulary latent variable compared with the waiting control group. Differential effects were found on some non‐standardized intervention‐specific measures with the narrative group making significantly more progress on narrative tasks compared with the waiting control group, the vocabulary group showing the same pattern on specific vocabulary tasks, and the combined narrative and vocabulary group making significantly more progress on some of the intervention‐specific narrative, and all the intervention‐specific vocabulary outcomes compared with the waiting control group. Conclusions & Implications: It is possible to improve narrative but not vocabulary skills, as assessed by standardized measures, in secondary school students with a relatively brief group TA‐delivered intervention. There were differential effects for both narrative and vocabulary with intervention‐specific measures. Future work is required to explore whether more intensive and longer lasting interventions would be more effective and to identify which students in this age group are most likely to benefit from such interventions. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the efficacy of a 0.03% chlorhexidine and 0.05% cetylpyridinium chloride mouth rinse, as an adjunct to professionally and patient‐administered mechanical plaque removal, in the treatment of peri‐implant mucositis (PiM). Material and Methods: Patients displaying PiM in, at least, one implant were included in this randomized, double‐blinded, clinical trial. Subjects received professional prophylaxis (baseline and 6 months) and were instructed to regular oral hygiene practices and to rinse, twice daily, with the test or placebo mouth rinses, during one year. Clinical, radiographic and microbiological outcomes were evaluated at baseline, 6 and 12 months. Disease resolution was defined as absence of bleeding on probing (BOP). Data were analysed by repeated measures ANOVA, Student's t and chi‐square tests. Results: Fifty‐four patients were included and 46 attended the final visit (22 in control and 24 in test group). In the test group, there was a 24.49% greater reduction in BOP at the buccal sites (95% confidence interval [3.65–45.34%]; p = 0.002) than in controls. About 58.3% of test implants and 50% controls showed healthy peri‐implant tissues at final visit (p > 0.05). Conclusions: The use of the test mouth rinse demonstrated some adjunctive benefits in the treatment of PiM. Complete disease resolution could not be achieved in every case. [ABSTRACT FROM AUTHOR]

In this systematic review and meta-analysis, we evaluated the effectiveness, safety and comfort of StatLock for the securement of peripherally-inserted central catheters. PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure, WanFang Database, and China Science and Technology Journal Database were searched. Randomized, controlled trials comparing StatLock with tape or suture on the performance of securing peripherally-inserted central catheters were selected. Meta-analysis was performed using Review Manager 5.3 software. Thirteen randomized, controlled trials involving 1970 patients were included. Our results showed that StatLock reduced the incidence of catheter dislodgement and unplanned removal. Moreover, patients in the StatLock group had lower incidence of skin ulceration, phlebitis, catheter-related bloodstream infection, and cellulitis, and felt more comfortable compared with those in the control group. Current evidence suggests that the StatLock securement device offer advantages over tape and suture in preventing catheter-related complications and improving patient comfort. However, as considerable heterogeneity was found among the included studies, and the quality of evidence for main outcomes was relatively low, the results should be viewed with caution. [ABSTRACT FROM AUTHOR]

Abstract: Unconditional cash transfers (UCTs) are used as a humanitarian intervention to prevent acute malnutrition, despite a lack of evidence about their effectiveness. In Niger, UCT and supplementary feeding are given during the June–September “lean season,” although admissions of malnourished children to feeding programmes may rise from March/April. We hypothesised that earlier initiation of the UCT would reduce the prevalence of global acute malnutrition (GAM) in children 6–59 months old in beneficiary households and at population level. We conducted a 2‐armed cluster‐randomised controlled trial in which the poorest households received either the standard UCT (4 transfers between June and September) or a modified UCT (6 transfers from April); both providing 130,000 FCFA/£144 in total. Eligible individuals (pregnant and lactating women and children 6–<24 months old) in beneficiary households in both arms also received supplementary food between June and September. We collected data in March/April and October/November 2015. The modified UCT plus 4 months supplementary feeding did not reduce the prevalence of GAM compared with the standard UCT plus 4 months supplementary feeding (adjusted odds ratios 1.09 (95% CI [0.77, 1.55], p = 0.630) and 0.93 (95% CI [0.58, 1.49], p = 0.759) among beneficiaries and the population, respectively). More beneficiaries receiving the modified UCT plus supplementary feeding reported adequate food access in April and May (p < 0.001) but there was no difference in endline food security between arms. In both arms and samples, the baseline prevalence of GAM remained elevated at endline (p > 0.05), despite improved food security (p < 0.05), possibly driven by increased fever/malaria in children (p < 0.001). Nonfood related drivers of malnutrition, such as disease, may limit the effectiveness of UCTs plus supplementary feeding to prevent malnutrition in this context. Caution is required in applying the findings of this study to periods of severe food insecurity. [ABSTRACT FROM AUTHOR]

Objective: To establish whether the infusion method trial of void (TOV) after a mid‐urethral sling procedure, in contrast to the standard auto‐fill TOV, permits discharge home from recovery, as these procedures are eminently suited to same day discharge, and the delay in achieving a successful TOV often keeps the patient in hospital overnight. Method: A randomised controlled trial performed between December 2014 and April 2016 at the University Hospital, enrolling 40 women undergoing a mid‐urethral sling procedure for stress urinary incontinence. The women were randomised to infusion method or auto‐fill method TOV. The primary outcome was discharge home from the recovery area of theatre. Results: Discharge from recovery was not different between the two groups (odds ratio (OR) 1.3 95% CI: 0.3–5.9, P = 0.71). The rate of TOV being successfully passed in recovery was higher in the infusion‐fill group compared to the standard auto‐fill group (OR 4.5 95% CI 1.2–17.4, P = 0.025). This means that three women will undergo the infusion‐fill to achieve one more successful TOV in recovery. Conclusions: The infusion method resulted in more women passing their TOV in recovery but this did not translate into more discharges from recovery. [ABSTRACT FROM AUTHOR]

Abstract: Background: Constraint‐induced (language) aphasia therapy (CIAT), based on constraint usage of the language channel only, massed practice and shaping through therapeutic language games, has been suggested as a more efficient therapy approach than traditional aphasia therapies. Aims: To examine the comparative efficacy of CIAT and a traditional therapy approach on expressive language ability, with the intensity of therapy controlled and matched, in the treatment of post‐stroke aphasia. Methods & Procedures: Two successive 4‐week blocks of intense (1 h, 5 days a week) of aphasia therapy programmes were delivered in a randomized within‐subject crossover design: one therapy block consisted of stimulation aphasia therapy (SAT, a common traditional therapy approach), another of CIAT. Twenty consecutive patients, up to 1 year after stroke, were randomly assigned either to have SAT followed by CIAT (S1C2 group) or to have CIAT followed by SAT (C1S2 group). Measurements of naming (Boston Naming Test) and spontaneous sentence production (Cookie Theft Picture description task) were carried at the baseline, following the first therapy block, following the second therapy block and 4 weeks following the last therapy block. Outcomes & Results: Both groups of patients significantly improved in all variables of expressive language skills; the improvement was maintained 1 month post‐treatment. However, patients who started with CIAT and continued with SAT (C1S2 group) tended to have higher final improvement than the patients who started with SAT and continued with CIAT (S1C2 group). This was particularly pronounced for naming. Moreover, when CIAT was the first therapy (the C1S2 group) the improvement achieved in naming following CIAT significantly exceeded the improvements achieved following SAT, not only in the same group (when SAT was the second) but also in the S1C2 group (when SAT was the first). In addition, the improvement in naming following CIAT in the C1S2 group exceeded the one in the S1C2 group, too. Similarly, the improvement in the total number of sentences produced following each therapy was quite clear and significant in the C1S2 group (when CIAT was the first), while in the S1C2 group it was much more modest and not significant. Conclusions & Implications: Results suggest that the maximization of quantity and frequency of language therapy have a significant impact on the improvement of expressive language ability. Moreover, if practised early in aphasia therapy, the constrained usage of the language modality, as practised in CIAT, confers an additional benefit to massed practice, particularly on naming ability. [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]

ABSTRACT Intensive behavioral counseling interventions combined with nicotine replacement therapy have increased smoking abstinence rates in cardiac patients, but little is known about their feasibility when initiated upon hospital admission and continued post-discharge. The current study was an evaluation of the use, appreciation, and fidelity of two post-discharge counseling interventions designed for cardiac patients to quit smoking that differed in their delivery mode. In a controlled trial with cross-over randomization at the cardiac unit level, hospitalized smokers in eight cardiac units of eight Dutch hospitals were assigned either telephone counseling ( n = 223) or nurse-administered face-to-face counseling ( n = 157) using the Ask-Advise-Refer strategy. Eligible patients also received nicotine replacement therapy. Data based on counselors' registration forms and patients' telephone surveys at 6-month follow-up were analyzed. Most patients (>90%) participated in at least one counseling session, and the majority participated in at least five out of a maximum of seven sessions. Higher levels of adherence to either the telephone or face-to-face counseling sessions were associated with higher smoking abstinence rates at the 6-month follow-up, whereas higher nicotine patch use was not associated with abstinence. Patients positively evaluated the content, duration, and number of sessions, and rated the face-to-face counseling significantly better than the telephone counseling for quitting smoking. The counselors largely complied with the intervention protocols. The current intervention offers evidence of feasibility and may improve outpatient continuity of smoking care. Monitoring the use and delivery of such complex interventions is recommended to promote effective dissemination in cardiac practice. [ABSTRACT FROM AUTHOR]

Cardiac disease and type 2 diabetes are prevalent diseases globally. Cardiac rehabilitation and diabetes self-management programs empower patients' self-management to improve their health outcomes. However, inappropriate delivery modes and continuing low participation rates indicate some programs are less than optimal. A previous study demonstrated the feasibility of incorporating telephone and text messages into a cardiac-diabetes self-management program in Australia; however, the program did not specifically address patients' cultural backgrounds. This current study used a randomized blocked design to evaluate short-term efficacy of the cardiac-diabetes self-management program incorporating telephone and text-messaging across different cultural contexts in Australia and Taiwan in comparison to usual care. No significant differences between groups were observed for outcomes of self-care behavior, self efficacy, knowledge and health-related quality of life, with patients in both groups demonstrating improvements. Patient-reported outcomes indicated some evidence of an interaction effect between country of origin and group allocation. Findings indicated an improved tendency of outcome measures between the baseline and follow-up assessments within usual care and intervention groups. Further research is required to clarify components of the program work for each cultural group. [ABSTRACT FROM AUTHOR]

Background and aims Contingency management (CM) is one of the most effective behavioral interventions to promote drug abstinence, but availability of this treatment is limited. We evaluated the efficacy and acceptability of internet-based CM relative to an internet-based monitoring and goal-setting control group in a nationwide sample of cigarette smokers. Design Randomized controlled trial with 3- and 6-month follow-ups. Setting United States. Participants Smokers ( n = 94) from 26 states were enrolled (mean age 36, 56% female). Intervention and comparator Participants were randomized to earn financial incentives (up to $480 over 7 weeks) based on video-verified abstinence using breath carbon monoxide (CO) output ( n = 48; abstinent contingent group, AC), or based on submitting CO samples ( n = 46, submission contingent, SC). Both groups also received the same CO-based goals. A $50 deposit was required in both groups that could be recouped from initial earnings. Measures The primary outcome was point prevalence at week 4. Secondary outcomes were point prevalence at the 3- and 6-month follow-ups, percentages of negative CO samples, adherence to the CO sampling protocol, and treatment acceptability ratings on a 0-100-mm visual analog scale. Findings Abstinence rates differed at 4 weeks between the AC (39.6%) and SC (13.0%) groups [odds ratio (OR) = 4.4, 95% confidence interval (CI) = 1.6-12.3], but not at the 3- (29.2% AC and 19.6% SC, OR = 1.7, 95% CI = 0.6-4.4) or 6- (22.9% AC and 13.0% SC, OR = 2.0, 95% CI = 0.7-5.9) month follow-ups. During the two main treatment phases, there were significant differences in negative COs (53.9% AC and 24.8% SC, OR = 3.5, 95% CI = 3.1-4.0; 43.4% AC and 24.6% SC, OR = 2.3, 95% CI = 1.6-3.4). Adherence to the CO submission protocol was equivalent (78% AC and 85% SC, difference = 7.0%, 95% CI = −10.3 to 23.8 %, F < 1, P = 0.39). The lowest acceptability ratings were for the items assessing the deposit, whereas the highest ratings concerned the ease of the intervention, the graph of CO results, and earning money. Conclusions A contingency management/financial incentive program delivered via the internet improved short-term abstinence rates compared with an internet program without the incentives. [ABSTRACT FROM AUTHOR]

Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug-related death soon after release from prison. The NALoxone InVEstigation (N-ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone-on-release (NOR) to eligible prisoners in England. Design. Parallel-group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre-randomization, release due within 3 months and more than 6 months since previous N-ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single 'rescue' injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self-questionnaires (RPSQs: 207), NOR-carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70-74%]; 218 RPSQs were received; NOR-carriage (95% CI = 63-79%) and overdose presence (95% CI = 75-84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one-third of NOR administrations were to the ex-prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take-home emergency naloxone prior to prison release may be a life-saving interim measure to prevent heroin overdose deaths among ex-prisoners and the wider population. [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]

Background: The extant literature demonstrates that children with autism spectrum disorder (ASD) often have difficulty interacting and socially connecting with typically developing classmates. However, some children with ASD have social outcomes that are consistent with their typically developing counterparts. Little is known about this subgroup of children with ASD. This study examined the stable (unlikely to change) and malleable (changeable) characteristics of socially successful children with ASD. Methods: This study used baseline data from three intervention studies performed in public schools in the Southwestern United States. A total of 148 elementary-aged children with ASD in 130 classrooms in 47 public schools participated. Measures of playground peer engagement and social network salience (inclusion in informal peer groups) were obtained. Results: The results demonstrated that a number of malleable factors significantly predicted playground peer engagement (class size, autism symptom severity, peer connections) and social network salience (autism symptom severity, peer connections, received friendships). In addition, age was the only stable factor that significantly predicted social network salience. Interestingly, two malleable (i.e., peer connections and received friendships) and no stable factors (i.e., age, IQ, sex) predicted overall social success (e.g., high playground peer engagement and social network salience) in children with ASD. Conclusions: School-based interventions should address malleable factors such as the number of peer connections and received friendships that predict the best social outcomes for children with ASD. [ABSTRACT FROM AUTHOR]

Aims To test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit. Design A parallel-group randomized controlled trial of brief motivational ( n = 185), reduction ( n = 186) or usual care ( n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided. Setting United States. Participants A total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days. Measurements The primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began. Findings A priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09). Conclusions Among adult smokers who are not ready to quit, both logistic regression and Bayesian analysis indicate that neither motivational nor reduction-based telephone interventions increased the odds of making a quit attempt in comparison to usual care at 6 months. The motivational intervention appeared to increase abstinence at 6 months and did increase abstinence at 12 months. The reduction intervention did not increase abstinence at 6 months but appeared to increase abstinence at 12 months. [ABSTRACT FROM AUTHOR]

Aims To compare the use of alternative nicotine products, smoking behavior and tobacco biomarker exposure in smokers unwilling to quit who were assigned randomly to normal nicotine content (NNC) cigarettes or very low nicotine content (VLNC) cigarettes. Design Randomized, parallel-arm 8-week study with assignment to VLNC (VLNC 1, n = 53) or NNC (NNC, n = 27) with access to non-cigarette combusted and non-combusted tobacco/nicotine products or to VLNC with access to only non-combusted products (VLNC2, n = 56). Setting Clinics in Minnesota, USA. Participants Smokers uninterested in quitting smoking with a mean [± standard deviation (SD)] age of 44 (± 14) years and smoking 16 (± seven) cigarettes/day; 51% female, 72% white. Measurements During the experimental period, the measures taken included: rate of alternative products used, amount of and abstinence from combusted tobacco used and tobacco exposure biomarkers. Findings There were higher rates of non-combusted alternative tobacco/nicotine product use in both VLNC conditions versus the NNC condition [rate ratio (RR) = 2.18, 95% confidence interval (CI) = 1.94, 2.46 and RR = 1.64, 95% CI = 1.46, 1.85, respectively] and in VLNC1 versus VLNC2 condition (RR = 1.33, 95% CI = 1.23, 1.44), accompanied by reduced biomarkers of exposure primarily in VLNC2 condition compared to NNC condition ( Ps < 0.05). Fewer combusted products were smoked at almost all visits ( Ps ≤ 0.02) and there were higher rates of abstinence for both VLNC conditions compared with the NNC condition (VLNC1 versus NNC: RR = 9.96, 95% CI = 5.01, 19.81; VLNC2 versus NNC: RR = 11.23, 95% CI = 5.74, 21.97). Conclusion The offer of, and instructions to use, reduced nicotine content cigarettes during an 8-week period led to greater use of alternative tobacco/nicotine products compared with continued use of normal nicotine cigarettes and also reductions in smoking rates. [ABSTRACT FROM AUTHOR]

Background: Consistent with evidence from high-income countries (HICs), we previously showed that, in an informal peri-urban settlement in a low-middle income country, training parents in book sharing with their infants benefitted infant language and attention (Vally, Murray, Tomlinson, & Cooper, 2015). Here, we investigated whether these benefits were explained by improvements in carer-infant interactions in both book-sharing and non-book-sharing contexts. We also explored whether infant socioemotional development benefitted from book sharing. Methods: We conducted a randomized controlled trial in Khayelitsha, South Africa. Carers of 14-16-month-old infants were randomized to 8 weeks' training in book sharing (n = 49) or a wait-list control group (n = 42). In addition to the cognitive measures reported previously, independent assessments were made at base line and follow-up of carer-infant interactions during book sharing and toy play. Assessments were also made, at follow-up only, of infant prosocial behaviour in a ‘help task', and of infant imitation of doll characters' nonsocial actions and an interpersonal interaction. Eighty-two carer-infant pairs (90%) were assessed at follow-up. (Trial registration ISRCTN39953901). Results: Carers who received the training showed significant improvements in book-sharing interactions (sensitivity, elaborations, reciprocity), and, to a smaller extent, in toy-play interactions (sensitivity). Infants in the intervention group showed a significantly higher rate of prosocial behaviour, and tended to show more frequent imitation of the interpersonal interaction. Improvements in carer behaviour during book sharing, but not during toy play, mediated intervention effects on all infant cognitive outcomes, and tended to mediate intervention effects on infant interpersonal imitation. Conclusions: Training in book sharing, a simple, inexpensive intervention that has been shown to benefit infant cognitive development in a low-middle income country, also shows promise for improving infant socioemotional outcomes in this context. Benefits are mediated by improvements in carer-infant interactions, particularly in book-sharing contexts. [ABSTRACT FROM AUTHOR]