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

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

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

Background: The articulatory accuracy of patients with dysarthria is one of the most affected speech dimensions with a high impact on speech intelligibility. Behavioural treatments of articulation can either involve direct or indirect approaches. The latter have been thoroughly investigated and are generally appreciated for their almost immediate effects on articulation and intelligibility. The number of studies on (short‐term) direct articulation therapy is limited. Aims: To investigate the effects of short‐term, boost articulation therapy (BArT) on speech intelligibility in patients with chronic or progressive dysarthria and the effect of severity of dysarthria on the outcome. Methods & Procedures: The study consists of a two‐group pre‐/post‐test design to assess speech intelligibility at phoneme and sentence level and during spontaneous speech, automatic speech and reading a phonetically balanced text. A total of 17 subjects with mild to severe dysarthria participated in the study and were randomly assigned to either a patient‐tailored, intensive articulatory drill programme or an intensive minimal pair training. Both training programmes were based on the principles of motor learning. Each training programme consisted of five sessions of 45 min completed within one week. Outcomes & Results: Following treatment, a statistically significant increase of mean group intelligibility was shown at phoneme and sentence level, and in automatic sequences. This was supported by an acoustic analysis that revealed a reduction in formant centralization ratio. Within specific groups of severity, large and moderate positive effect sizes with Cohen's d were demonstrated. Conclusions & Implications: BArT successfully improves speech intelligibility in patients with chronic or progressive dysarthria at different levels of the impairment. What this paper addsWhat is already known on the subjectBehavioural treatment of articulation in patients with dysarthria mainly involves indirect strategies, which have shown positive effects on speech intelligibility. However, there is limited evidence on the short‐term effects of direct articulation therapy at the segmental level of speech. This study investigates the effectiveness of BArT on speech intelligibility in patients with chronic or progressive dysarthria at all severity levels.What this paper adds to existing knowledgeThe intensive and direct articulatory therapy programmes developed and applied in this study intend to reduce the impairment instead of compensating it. This approach results in a significant improvement of speech intelligibility at different dysarthria severity levels in a short period of time while contributing to exploit and develop all available residual motor skills in persons with dysarthria.What are the potential or actual clinical implications of this work?The improvements in intelligibility demonstrate the effectiveness of a BArT at the segmental level of speech. This makes it to be considered a suitable approach in the treatment of patients with chronic or progressive dysarthria. [ABSTRACT FROM AUTHOR]

Background: A total of 68% of pre‐school children with cleft palate have speech problems requiring speech therapy. There is a lack of access to regular targeted therapy. Parent training leads to positive outcomes in early communication skills in cleft palate and non‐cleft speech disorders. Connected health has been used to address inadequate access to therapy, providing intervention to those who would not otherwise receive therapy. Aims: To evaluate the speech, activity and participation outcomes of Parent Led, Therapist Supervised, Articulation Therapy (PLAT) compared with routine speech therapy intervention in parent–child dyads. Methods & Procedures: A total of 44 children, aged 2.9–7.5 years, were included in a two‐centre, two‐phase randomized controlled trial. Informed consent and assent were obtained. Participants and speech and language therapists (SLTs) were unblinded to the groups. Parents, in the parent‐trained group (n = 23), attended 2 days' training, received a detailed speech therapy programme, and undertook intervention over 12 weeks supported by the cleft specialist SLT using FaceTime and one face‐to‐face session. In the control arm (n = 21), parent–child dyads received six therapy sessions over 12 weeks with a research SLT, comparable with usual care. Speech recordings were undertaken pre‐ and post‐intervention. Percent consonant correct (PCC) was analysed by external SLTs blinded to the time and group. Activity and participation were measured using the Intelligibility in Context Scale (ICS) and Focus on Outcomes for Children Under Six (FOCUS) questionnaire. Outcomes & Results: There was no evidence of an interaction between Time and Group or an overall statistical difference between groups for PCC scores. There was a statistically significant difference over time for both groups (words: p < 0.002; confidence interval (CI) = 9.38–16.27; d = 0.57; sentences: p < 0.002; CI = 16.04–25.97; d = 0.23). Effect sizes were medium for words and small for sentences. For intelligibility and participation, there was no evidence of an interaction between Time and Group or an overall statistical difference between groups. A statistically significant difference over time was found for intelligibility (F = 29.97, d.f. = 1, 42, p < 0.001, 95 % CI = 1.45–3.15 d = 0.46) and for participation (F = 14.19, d.f. = 1, 41, p < 0.001 95% CI = 7.63–25.03; d = 0.36) with FOCUS results indicating clinically meaningful (parent‐led group) and significant (control group) change in participation. Conclusions & Implications: PLAT can be as effective as routine care in changing speech, activity and participation outcomes for children with cleft palate, when supported by a specialist cleft SLT using connected health. What this paper addsWhat is already known on this subjectOver 50% of children with cleft palate require speech therapy. However, there is a lack of timely, accessible speech therapy services in the UK and Ireland. Previous studies have shown that parents can deliver therapy effectively, and that connected health can support the delivery of speech therapy. This study aims to provide evidence that parent‐led therapy with the supervision of a specialist cleft therapist using FaceTime is effective.What this paper adds to existing knowledgeThis randomized controlled trial indicates that parents can be trained to deliver therapy for children with cleft palate speech disorders, under the supervision of an SLT. This approach results in improved speech, activity and participation outcomes similar to routine care.What are the potential or actual clinical implications of this work?This study indicates that both parent‐led articulation therapy and routine care showed meaningful gains in speech, activity and participation, and that parent‐led articulation therapy when supported by a cleft SLT using connected health could be an additional service delivery model for children with cleft palate speech disorders. [ABSTRACT FROM AUTHOR]

Given the widespread use of touch screen devices, the effect of the users' fingers on information processing and learning is of growing interest. The present study drew on cognitive load theory and embodied cognition perspectives to investigate the effects of pointing and tracing gestures on the surface of a multimedia learning instruction. Learning performance, cognitive load and visual attention were examined in a one‐factorial experimental design with the between‐subject factor pointing and tracing gestures. The pointing and tracing group were instructed to use their fingers during the learning phase to make connections between corresponding text and picture information, whereas the control group was instructed not to use their hands for learning. The results showed a beneficial effect of pointing and tracing gestures on learning performance, a significant shift in visual attention and deeper processing of information by the pointing and tracing group, but no effect on subjective ratings of cognitive load. Implications for future research and practice are discussed. Lay Description: What is currently known about the subject matter? Pointing and tracing gestures enhance learning with multimediaThe effect is true for paper based and digital learning instructionsLess is known about the cause of this effect with regard to complex learningDifferent theoretical explanations are currently discussed What our paper adds to this A detailed analysis of the effect using eye‐tracking and touch screen dataEvidence that the effect of pointing and tracing is mediated by eye‐movementsRelevant information concerning the discussion about theoretical explanations The implications of study findings for practitioners Pointing and tracing gestures can guide the learners' visual focus of attentionPointing and tracing gestures can increase the learners' visual attentionPointing and tracing gestures foster information processing when learning with multimediaLearners can or even should use pointing and tracing gestures to support learning [ABSTRACT FROM AUTHOR]

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

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]

Aim To report the evidence on the effect of mechanical and/or chemical plaque control in the simultaneous management of gingivitis and caries. Material and Methods A protocol was designed to identify randomized ( RCTs) and controlled ( CCTs) clinical trials, cohort studies and prospective case series ( PCS), with at least 6 months of follow-up, reporting on plaque, gingivitis and caries. Relevant information was extracted from full papers, including quality and risk of bias. Meta-analyses were performed whenever possible. Results After the screening of 1,373 titles, 15 RCTs, 10 CCTs and 2 PCS were included. Low to moderate evidence support that combined professional and self-performed mechanical plaque control significantly reduces standardized plaque index [ n = 4; weighted mean difference ( WMD) = 1.294; 95% CI (0.445; 2.144); p = 0.003] and gingivitis scores [ n = 4; WMD = 1.728; 95% CI (0.631; 2.825); p = 0.002]. The addition of fluoride to mechanical plaque control is relevant for caries management [ n = 5; WMD = 1.159; 95% CI (0.145; 2.172); p = 0.025] while chlorhexidine rinses are relevant for gingivitis. Conclusion Mechanical plaque control procedures are effective in reducing plaque and gingivitis. The addition of fluoride to mechanical plaque control is significant for caries management. Chlorhexidine rinse has a positive effect on gingivitis and inconclusive role in caries. [ABSTRACT FROM AUTHOR]

Background and Aims It has been proposed that more use should be made of Bayes factors in hypothesis testing in addiction research. Bayes factors are the ratios of the likelihood of a specified hypothesis (e.g. an intervention effect within a given range) to another hypothesis (e.g. no effect). They are particularly important for differentiating lack of strong evidence for an effect and evidence for lack of an effect. This paper reviewed randomized trials reported in Addiction between January and June 2013 to assess how far Bayes factors might improve the interpretation of the data. Methods Seventy-five effect sizes and their standard errors were extracted from 12 trials. Seventy-three per cent ( n = 55) of these were non-significant (i.e. P > 0.05). For each non-significant finding a Bayes factor was calculated using a population effect derived from previous research. In sensitivity analyses, a further two Bayes factors were calculated assuming clinically meaningful and plausible ranges around this population effect. Results Twenty per cent ( n = 11) of the non-significant Bayes factors were < ⅓ and 3.6% ( n = 2) were > 3. The other 76.4% ( n = 42) of Bayes factors were between ⅓ and 3. Of these, 26 were in the direction of there being an effect (Bayes factor > 1 and < 3); 12 tended to favour the hypothesis of no effect (Bayes factor < 1 and > ⅓); and for four there was no evidence either way (Bayes factor = 1). In sensitivity analyses, 13.3% of Bayes Factors were < ⅓ ( n = 20), 62.7% ( n = 94) were between ⅓ and 3 and 24.0% ( n = 36) were > 3, showing good concordance with the main results. Conclusions Use of Bayes factors when analysing data from randomized trials of interventions in addiction research can provide important information that would lead to more precise conclusions than are obtained typically using currently prevailing methods. [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 Despite harmful drinking causing a significant burden on global health, there is a large treatment gap, especially in low- and middle-income countries. A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments. This paper describes the systematic process used to develop Counselling for Alcohol Problems ( CAP), a brief psychological treatment (PT) for delivery by lay counselors in routine primary care settings to men with harmful drinking in India. Methods CAP was developed using a methodology involving 3 sequential steps: (i) identifying potential treatment strategies; (ii) developing a theoretical framework for the treatment; and (iii) evaluating the acceptability and feasibility of the treatment. Results CAP is a 3-phase treatment delivered over 1 to 4 sessions based on a motivational interviewing ( MI) stance and involves the following strategies: assessment and personalized feedback, family engagement, drink refusal skills, skills to address drinking urges, problem-solving skills and handling difficult emotions, and relapse prevention and management. Data from a case series were used to inform several adaptations to enhance the acceptability of CAP to the recipients and feasibility of delivery by lay counselors of the treatment, for example expansion of the target group to include alcohol-dependent patients and the extension of the delivery settings to include home-based delivery. There was preliminary evidence of the effectiveness of CAP. Conclusions CAP is an acceptable brief PT for harmful drinking delivered by lay counselors in primary care whose effectiveness is currently being tested in a randomized controlled trial based in primary care in Goa, India. [ABSTRACT FROM AUTHOR]

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

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]

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

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

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

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

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]

Aims: Assess effectiveness of a hybrid intervention targeting physical activity in women with prior gestational diabetes. Methods: Randomised controlled trial with parallel arms. 293 women (35.1 ± 5.1 years; 40% ethnic minority) recruited from two hospitals and randomised to routine care or hybrid lifestyle intervention comprising two group sessions and access to a mobile web app. Primary outcome was a change in objectively measured physical activity at 12 months. Secondary outcomes included self‐efficacy for exercise, quality of life and anxiety and depression. Linear regression compared outcome measures between groups. Results: 83% of intervention participants attended at least one group session, of who 66% registered to use the app. There was a non‐significant increase in physical activity at 12 months (between‐group difference of 0.95 mg [95% CI: −0.46 to 2.37]), equivalent to approximately 500 steps per day. Intervention participants reported higher self‐efficacy for exercise (0.54, 95% CI: 0.05 to 1.102; p = 0.029), lower anxiety (−0.91, 95% CI: −1.74 to −0.09; p = 0.031), and higher quality of life (0.05, 95% CI: 0.004 to 0.09; p = 0.032), compared to controls. Conclusions: The intervention improved confidence in exercise and quality of life. Further research is needed to improve participant engagement with physical activity interventions in multi‐ethnic populations with a history of gestational diabetes. [ABSTRACT FROM AUTHOR]

Aim: To answer the following PICO question: In systemically healthy humans with peri‐implant mucositis, what is the efficacy of patient‐performed or administered (by prescription) measures used adjunctively to submarginal instrumentation, as compared to submarginal instrumentation alone or combined with a negative control, in terms of reducing bleeding on probing (BOP), in randomized controlled clinical trials (RCTs) with at least 3 months of follow‐up? Materials and Methods: Three databases were searched until April 2022. Weighted mean differences (WMDs) with 95% confidence intervals (CIs) and predictive intervals were calculated. Results: Sixteen parallel RCTs corresponding to 14 studies with low/moderate risk of bias were included. Test groups showed greater reductions in BOP (%) than control groups (nstudies = 16; npatients = 650; WMD = 14.25%; 95% CI [9.06–19.45]; p <.001; I2 = 98.7%). The greatest WMD in BOP reductions (%) were obtained by antiseptics (ns = 5; np = 229; WMD = 22.72%; 95% CI [19.40–26.04]; p < 0.001; I2 = 94.8%), followed by probiotics (ns = 6; np = 260; WMD = 12.11%; 95% CI [3.20–21.03]; p =.008; I2 = 93.3%) and systemic antibiotics (ns = 3; np = 101; WMD = 5.97%; 95% CI [1.34–10.59]; p =.012; I2 = 58.1%). Disease resolution was scarcely reported (n = 6). Conclusions: Significant clinical improvements can be obtained when professional submarginal instrumentation is combined with patient‐performed or administered (by prescription) adjunctive measures, although a complete disease resolution may not be achieved. [ABSTRACT FROM AUTHOR]

Exclusive breastfeeding (EBF) for the first 6 months has established benefits, yet had slow improvements globally. Little is known about electronic job aid‐assisted counselling to support EBF. As a secondary outcome of a cluster randomized controlled trial in Bangladesh, we assessed the effect of electronic job aid‐supported nutrition counselling and practical demonstration on EBF. We randomized pregnant women to one of five study arms in the trial and followed mother–child dyads until 2 years of age. Community health workers (CHWs) provided breastfeeding counselling with or without prenatal and complementary nutrient supplements in all four intervention arms. The comparison arm continued with the usual practice where mothers could receive nutrition counselling at routine antenatal and postnatal care, and during careseeking for childhood illnesses. We assessed breastfeeding indicators at birth and monthly until the child was 6 months old, in both intervention and comparison arms. To evaluate the effect of nutrition counselling on breastfeeding, we combined all four intervention arms and compared them with the comparison arm. Intervention newborns had half the risk (relative risk [RR]: 0.54, 95% confidence interval [CI]: 0.39, 0.76) of receiving prelacteal feeds than those in the comparison arm. EBF declined steeply in the comparison arm after 3 months of age. EBF was 16% higher in the intervention than the comparison arm at 4 months (RR: 1.16, 95% CI: 1.08, 1.23) and 22% higher at 5 months of age (RR: 1.22, 95% CI: 1.12, 1.33). Maternal background and household characteristics did not modify the intervention effect, and we observed no difference in EBF among caesarean versus vaginal births. Breastfeeding counselling and practical demonstration using an electronic job aid by CHWs are promising interventions to improve EBF and are scalable into existing community‐based programmes. Key messages: Using an electronic job aid, repeated, one‐to‐one counselling and practical demonstration to mothers by locally recruited CHWs reduced prelacteal feeding and improved EBF practice by delaying the early introduction of complementary food.The positive effect of counselling on EBF remains similar with or without nutrient supplementation.Electronic job aid supported counselling to promote breastfeeding should be integrated into existing community‐based maternal and child health programmes. [ABSTRACT FROM AUTHOR]

Purpose: This study assessed the effects of massage therapy using 5% lavender oil on the severity of restless legs syndrome (RLS) and the quality of life (QoL) of patients on hemodialysis (HD). Design and methods: This is a randomized placebo‐controlled study with a pretest–posttest design. This study was conducted from January 30, 2019, to May 6, 2019, at HD centers in Turkey, and it includes 58 participants—31 study patients and 27 controls. Data were collected using patient identification form, RLS severity rating scale, Kidney Disease Quality of Life Scale (KDQOLTM‐36) and patient follow‐up charts. As per the massage therapy protocol, the patients in the study and control groups received massage therapy with lavender oil and baby oil, respectively. Findings: RLS severity significantly decreased in all follow‐up weeks in the study group and in the first, second, and third follow‐up weeks in the control group. There were significant differences between the groups in terms of KDQOLTM‐36 subscales and total scores at the initial and final follow‐ups. Conclusion: In HD patients, massage with lavender oil lessened the severity of RLS and improved the QoL. Accordingly, this therapy can be recommended to HD patients. Clinical relevance: Massage therapy during HD sessions is easy, inexpensive, and patient‐friendly with no side effects. It is known to reduce symptoms and enable the patients to easily perform daily activities of living. Massage therapy with lavender oil is effective and can be easily applied to patients with RLS by nurses. Trial registration: This study was registered under the Clinical Trials protocol registration system (NCT04630470) upon completion. [ABSTRACT FROM AUTHOR]

Aims: To examine the effects of e‐learning on intimate partner violence (IPV) knowledge, preparatory/reinforcing behaviors for supporting IPV victims, and IPV screening of midwives and nurses. Methods: Participants were randomly assigned to the intervention group (IG: e‐learning) and control group (CG: no e‐learning). The primary outcome was the mean change in knowledge score. The secondary outcomes were the mean number of types of practiced preparatory/reinforcing behaviors and the proportions of participants who practice screening. Unpaired t tests were performed in intention‐to‐treat analysis. Results: Of the 88 participants, 45 were randomly assigned to the IG and 43 to the CG. For the post‐1‐test, the IG had a mean change in the knowledge score of 8.5 points with a significant difference from the 1.4 points in the CG (mean difference [MD] 7.1, 95% CI [4.1, 10.1]). The mean change between the pre‐test and the post‐2‐test was significantly larger in the IG (7.9 points) than in the CG (1.3 points) (MD 6.6, 95% CI [3.3, 9.9]). The mean number of types of practiced behaviors at the post‐1‐test and post‐2‐test was significantly higher in the IG than in the CG (MD 1.4, 95% CI [0.1, 2.8]). There was no significant difference in the proportions of participants who practice screening between the two groups postintervention. Conclusions: The e‐learning effectively improved knowledge and promoted preparatory/reinforcing behaviors. [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]

Micronutrient supplementation is widely used to prevent stunting in children under 5 years in low‐ and middle‐income countries (LMIC), but the impact of treatment has been disappointing, possibly due to non‐compliance. Our aim was to deliver long‐term micronutrient supplementation via a novel, culturally acceptable liquid food to improve linear growth in a high stunting prevalence region. In a randomised control trial, 971 children aged 6–72 months received either 'Chispuditos®' (n = 681), a hot drink (atole) fortified with micronutrients (atole + MN) (9 mg/zinc, 12.5 mg/iron), or lactose‐free milk (n = 290) for 18 months. Primary outcomes were changes in length/height‐for‐age (HAZ) score and the prevalence of stunting at 18‐month follow‐up. Adherence was monitored monthly, and 73% children in atole + MN group consumed at least half their daily zinc and iron requirement. At 18 months, there was no difference between the treatments in growth [mean change in HAZ −0.02 (95% CI −0.12, 0.08)] or stunting [atole + MN 41%, milk 41%; RR 0.99 (95% CI 0.84, 1.19)]. There were no differences in haemoglobin (HB), ferritin or zinc. No children had iron deficiency anaemia (IDA) at outcome, but zinc deficiency remained equally prevalent in both groups: atole + MN 35%, milk 35% [RR 1.02 (95% CI 0.83, 1.24)]. There was no difference in morbidity between the groups, and micronutrient status was unrelated to HAZ. Long‐term micronutrient supplementation via a culturally acceptable food had no impact on stunting or morbidity, raising the question of whether large‐scale micronutrient supplementation is worthwhile. [ABSTRACT FROM AUTHOR]

Adequate maternal healthcare practices are crucial to both maternal and infant nutrition outcomes. The Sylhet region of Bangladesh is vulnerable and performs poorly, as maternal and child health indicators are falling behind compared to other areas. Suchana, a large‐scale intervention programme aims to improve the health and nutritional status of mothers and children in this region. The objective of the present analysis is to assess the changes in indicators related to maternal healthcare practices among Suchana beneficiaries. We obtained data from the Suchana baseline and endline evaluation survey. Descriptive statistics were employed to summarize data. The following maternal healthcare practices were considered: if a Suchana beneficiary mother received antenatal care (ANC) from skilled service providers, took day time resting during pregnancy, consumed additional diet during pregnancy, took at least 100 iron‐folic acid (IFA) tablets during pregnancy and took a vitamin A capsule after delivery. Logistic regression analysis was performed to assess the impact of the Suchana intervention on maternal healthcare practices. The prevalence of the outcome variables at endline in the intervention area were as follows: 40% of mothers received at least four ANC from skilled service providers, 50% practiced daytime resting during pregnancy, 51% consumed additional diet during pregnancy, 41% took at least 100 iron‐folic acid tablets during pregnancy, 39% received postnatal care and 30% took a vitamin A capsule after delivery. The Suchana intervention significantly, positively improved indicators related to maternal healthcare practices; these findings support future larger‐scale programmes to improve maternal healthcare practices among vulnerable people in rural Bangladesh. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to compare the efficacy of two brushing methods (manual vs. sonic) in terms of plaque control after a session of professional mechanical plaque removal (PMPR). Methods: Subjects with gingivitis underwent a session of PMPR and were randomly assigned to sonic (SB) or manual brushing (MB). Oral hygiene instructions were provided at baseline (BL), 2 (T0a), 4 (T0b) and 6 weeks (T1) and 6 months (T2). Plaque Index (PI), Gingival Index (GI) and bleeding on probing (BoP) were measured at BL, T1 and T2. The proportion of sites with PI, GI and BoP was modelled at site level using a negative binomial regression fitted via generalized linear mixed model accounting for intra‐patient correlation. Results: Thirty‐two subjects were selected, 16 assigned to each group and 31 completed the study. PI, BoP and GI were comparable at BL. At T1, PI was successfully maintained at 6.21% for SB and 22.81% for MB, while at T2 reached 11.34% for SB and 28% for MB, favouring the SB group (p < 0.001). GI and BoP were significantly lower in the SB group at T1, with a BoP reduction for SB about 3 times higher than MB (p < 0.001). These parameters then levelled at T2 between the groups, with BOP reaching 0.14% versus 0.05% (p = 0.356) and GI 1.75% versus 3.52% (p = 0.020). Conclusion: Sonic brushing seemed to maintain a lower PI score compared to a manual brush at 6 months. BoP and GI resulted comparable. [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]

Background: Chronic pelvic pain (CPP) is a common condition which significantly impacts the quality of life and wellbeing of many women. Laparoscopy with histopathology is recommended for investigation of pelvic pain and identification of endometriosis with concurrent removal. Never‐the‐less, the association between endometriosis and pelvic pain is challenging, with endometriosis identified in only 30–50% of women with pain. Aims: To explore the predictors for undergoing surgery, for identifying endometriosis and endometriosis severity in a cohort of women with CPP. Materials and Methods: This study forms part of the Persistent Pelvic Pain project, a prospective observational cohort study (ANZCTR:ACTRN12616000150448). Women referred to a public gynaecology clinic with pain were randomised to one of two gynaecology units for routine care and followed for 36 months with 6‐monthly surveys assessing demographics, medical history, quality of life, and pain symptoms measured on a Likert scale. Operative notes were reviewed and endometriosis staged. Results: Of 471 women recruited, 102 women underwent laparoscopy or laparotomy, of whom 52 had endometriosis (n = 37 stage I–II; n = 15 Stage III–IV). Gynaecology unit, pelvic pain intensity and lower parity were all predictors of surgery (odds ratio (OR) 0.342; 95% CI 0.209–0.561; OR 1.303; 95% CI: 1.079–1.573; OR 0.767; 95% CI: 0.620–0.949, respectively). There were no predictors identified for endometriosis diagnosis and the only predictor of severity was increasing age (OR 1.155; 95% CI: 1.047–1.310). Conclusions: Gynaecology unit and pain intensity were key predictors of undergoing laparoscopy; however, pain severity did not predict endometriosis diagnosis or staging. These findings indicate the need to review current frameworks guiding practice toward surgery for pelvic pain. [ABSTRACT FROM AUTHOR]

Eggs are a rich source of multiple nutrients that support child growth and development. Provision of eggs as a complementary food may improve dietary adequacy among young children at risk for undernutrition. Our objective was to test the impact of an egg intervention on the adequacy of total nutrient intakes and micronutrient density among 6‐ to 15‐month‐old Malawian children. Children 6 to 9 months old, living in Mangochi District, Malawi, were randomly assigned to the intervention group (n = 331) receiving an egg per day or a control group (n = 329) consuming their usual diet. Dietary intakes of macronutrients, vitamins and minerals were assessed using 24‐h recalls at baseline, 3‐month midline and 6‐month endline, with repeat recalls in a subsample. Usual nutrient intake and micronutrient density distributions were modelled to estimate group means and prevalence of inadequacy. Group differences at midline and endline were tested using unequal variance t tests with bootstrapped standard errors. The egg intervention resulted in higher intakes of fat and protein and lower intakes of carbohydrates. The egg group had lower prevalence of inadequacy for selenium, vitamin A, riboflavin, vitamin B5, vitamin B12 and choline. Micronutrient density inadequacy was lower in the egg group for vitamin A and choline at midline and endline, riboflavin at midline and vitamin B5 at endline. Inadequacy of nutrient intakes or density remained highly prevalent in both groups for multiple micronutrients. Though the egg intervention increased intakes of protein and several micronutrients, total intakes and micronutrient density of multiple micronutrients remained far below recommendations. [ABSTRACT FROM AUTHOR]

Ready‐to‐use therapeutic foods (RUTF) used to treat children with severe acute malnutrition (SAM) are costly, and the prescribed dosage has not been optimized. The MANGO trial, implemented by Action Contre la Faim in Burkina Faso, proved the non‐inferiority of a reduced RUTF dosage in community‐based treatment of uncomplicated SAM. We performed a cost‐minimization analysis to assess the economic impact of transitioning from the standard to the reduced RUTF dose. We used a decision‐analytic model to simulate a cohort of 399 children/arm, aged 6–59 months and receiving SAM treatment. We adopted a societal perspective: direct medical costs (drugs, materials and staff time), non‐medical costs (caregiver expenses) and indirect costs (productivity loss) in 2017 international US dollar were included. Data were collected through interviews with 35 caregivers and 20 informants selected through deliberate sampling and the review trial financial documents. The overall treatment cost for 399 children/arm was $36,550 with the standard and $30,411 with the reduced dose, leading to $6,140 (16.8%) in cost savings ($15.43 saved/child treated). The cost/consultation was $11.6 and $9.6 in the standard and reduced arms, respectively, with RUTF accounting for 56.2% and 47.0% of the total. The savings/child treated was $11.4 in a scenario simulating the Burkinabè routine SAM treatment outside clinical trial settings. The reduced RUTF dose tested in the MANGO trial resulted in significant cost savings for SAM treatment. These results are useful for decision makers to estimate potential economic gains from an optimized SAM treatment protocol in Burkina Faso and similar contexts. [ABSTRACT FROM AUTHOR]

This study in Burkina Faso investigated whether offspring of young mothers who had received weekly periconceptional iron supplementation in a randomised controlled trial were at increased risk of malaria. A child safety survey was undertaken in the peak month of malaria transmission towards the end of the trial to assess child iron biomarkers, nutritional status, anaemia and malaria outcomes. Antenatal iron biomarkers, preterm birth, fetal growth restriction and placental pathology for malaria and chorioamnionitis were assessed. Data were available for 180 babies surviving to the time of the survey when their median age was 9 months. Prevalence of maternal iron deficiency in the last trimester based on low body iron stores was 16%. Prevalence of active placental malaria infection was 24.8%, past infection 59% and chorioamnionitis 55.6%. Babies of iron supplemented women had lower median gestational age. Four out of five children ≥ 6 months were iron deficient, and 98% were anaemic. At 4 months malaria prevalence was 45%. Child iron biomarkers, anaemia and malaria outcomes did not differ by trial arm. Factors associated with childhood parasitaemia were third trimester C‐reactive protein level (OR 2.1; 95% CI 1.1–3.9), active placental malaria (OR 5.8; 1.0–32.5, P = 0.042) and child body iron stores (OR 1.13; 1.04–1.23, P = 0.002). Chorioamnionitis was associated with reduced risk of child parasitaemia (OR 0.4; 0.1–1.0, P = 0.038). Periconceptional iron supplementation of young women did not alter body iron stores of their children. Higher child body iron stores and placental malaria increased risk of childhood parasitaemia. [ABSTRACT FROM AUTHOR]

Background: Increasing numbers of frail elderly people living at home but dependent on supportive care will face complex oral health challenges. Objectives: To investigate the associations of frailty status with oral cleaning habits and oral hygiene taking into account the effects of preventive oral health intervention among home care clients aged 75 or over. Methods: Data were gathered by interviews and clinical oral examinations at baseline and after a 6‐month follow‐up. Frailty status was evaluated at baseline using the abbreviated comprehensive geriatric assessment (aCGA) scale, which consists of 15 questions from three different domains: cognitive status, functional status and depression. A total of 231 home care clients completed the aCGA at baseline and the interview and clinical oral examination both at baseline and after the follow‐up. Results: Using the aCGA classification with at least one score in the ≥2 domain, 62% of clients were classified as frail at baseline. They had poorer oral cleaning habits and hygiene, and they had lost more teeth than nonfrail participants. Multivariate analysis showed that being frail at baseline was statistically significantly associated with a lower frequency of toothbrushing and denture cleaning (OR = 0.4, 95% CI = 0.1–0.9 and OR = 0.3, 95% CI = 0.1–0.8) at baseline, but not after the follow‐up. Membership in the intervention group was associated with better oral cleaning at the follow‐up. However, among the frail participants, toothbrushing frequency was still significantly lower and oral hygiene poorer than among the nonfrail group. Conclusions: Oral cleaning habits of frail elderly people were slightly improved as a result of external support, which had a positive effect on oral hygiene. Individual preventive actions in the context of oral health and hygiene should be integrated into the daily care plan of home care clients with the first signs of frailty. [ABSTRACT FROM AUTHOR]

There are no guidelines for the optimal protein quality of ready‐to‐supplementary food (RUSF) for moderate acute malnutrition (MAM). This randomized, controlled, double‐blinded, clinical effectiveness trial evaluated two RUSFs in the treatment of MAM. Both foods contained greater than 7% dairy protein, but the protein‐optimized RUSF had a calculated digestible indispensable amino acid score (DIAAS) of 95%, whereas the control RUSF had a calculated DIAAS of 63%. There were 1,737 rural Malawian children 6–59 months of age treated with 75 kcal/kg/day of either control or protein quality‐optimized RUSF for up to 12 weeks. There was no difference in the proportion of children who recovered from MAM between the group that received protein‐optimized RUSF (759/860, 88%) and the group that received control RUSF (766/877, 87%, difference 1%, 95% CI, −2.1 to 4.1, p = 0.61). There were no differences in time to recovery or average weight gain; nor were adverse effects reported. Both RUSFs showed indistinguishable clinical outcomes, with recovery rates higher than typically seen in treatment for MAM. The DIAAS of these two RUSFs was measured using a pig model. Unexpectedly, the protein quality of the optimized RUSF was inferior to the control RUSF: DIAAS = 82% for the protein quality optimized RUSF and 96% for control RUSF. The controlled conditions of this trial suggest that in supplementary food products for MAM, protein quality is not an independent predictor of clinical effectiveness. [ABSTRACT FROM AUTHOR]

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

Background: Pre‐labour rupture of membranes (PROM) at term is a common event with early induction of labour reducing infectious morbidity without increasing the caesarean rate. Syntocinon is commonly used for induction but prostaglandins are also routinely used. Large studies have shown no difference in the maternal and neonatal outcomes with either method. Aim: To assess the safety and efficacy of vaginal prostaglandin (PG) compared to syntocinon for induction of labour in term‐PROM. Method: This was a single‐centre randomised controlled trial at Ipswich Hospital of women presenting at ≥37 weeks gestation with PROM. Women were randomised and managed in labour as per local guidelines. Analysis was by intention to treat. Results: One hundred and eighty‐four women were recruited, 90 in the PG group and 94 in the oxytocin group. Women in both arms were of similar demographics and 53% of women in the PG group did not require any oxytocin. There was a statistically significant lower incidence of fetal heart rate abnormality in the PG group, 4.4% versus 12.8%. There was no difference in epidural use, caesarean section, maternal infection, admission to special care nursery or neonatal sepsis. Time to onset of labour was significantly longer in the PG group, 25.7 h versus 19.7 h but with no difference in the length of first stage. Maternal satisfaction was high in both groups with no significant difference in breastfeeding rates. Conclusion: Induction of labour with oxytocin or vaginal prostaglandins are safe and efficacious options for women in the context of PROM at term. [ABSTRACT FROM AUTHOR]

Abstract: Background: Parent‐reported measures of early communication have limitations for use with infants experiencing adversity. Observational measures of early non‐verbal and verbal communicative behaviours and mother–child turn‐taking may provide a complementary method of capturing early communication skills for these children. Aims: To explore the predictive validity of verbal and non‐verbal behaviours and mother–child conversational turn‐taking (fluency and connectedness) at child age 12 months in relation to language measures at 24 and 36 months in a cohort of infants experiencing adversity. Methods & Procedures: Pregnant women experiencing adversity were recruited from maternity hospitals in Australia. At 12 months, 190 infants were videoed during mother–child free‐play. Verbal and non‐verbal communicative behaviours and fluency and connectedness were measured from the 12‐month videos. Predictive validity of 12‐month behaviours was calculated in relation to mean length of utterance and number of unique words at 24 months and Clinical Evaluation of Language Fundamentals Preschool—Second Edition (CELF‐P2) Core Language scores at 36 months. Outcomes & Results: All 12‐month behaviours had adequate specificity but poor sensitivity when compared with other predictive validity studies using published early language measures. However, in adjusted regression models, fluency and connectedness and verbal behaviours at 12 months predicted unique words at 24 months. Fluency and connectedness also predicted CELF‐P2 scores at 36 months. Conclusions & Implications: Findings reconfirm the difficulty in early identification of children at risk of later language difficulties. All 12‐month measures were more accurate at identifying those children who will have better language than those children who will not. As fluency and connectedness was the only measure to predict 24‐ and 36‐month language in adjusted regression models, it may be an important factor to consider when measuring early language skills for infants experiencing adversity. Future research could combine observational measures of early communication and fluency and connectedness with other predictors of language to try to increase prediction accuracy. [ABSTRACT FROM AUTHOR]

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

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 BACKGROUND Teen pregnancy rates and related risks remain elevated among Latino teens. We tested the impact on youth sexual behaviors of a brief, culturally targeted, bilingual media intervention designed for parents of young adolescents. METHODS Salud y éxito ( Health & Success) uses dramatic audio stories to model positive parenting practices. After completing classroom surveys, 27 urban schools in the Northeast and Southwest serving low-income Latino communities were randomized so that all families of seventh grade students were sent either: (1) booklets on healthy eating and exercise; (2) Salud-50, where families either received booklets or the intervention, or (3) Salud-100, where all families received the intervention. Postintervention follow-up surveys were conducted at 3- and 12-months. Multilevel analyses tested intervention effects, controlling for sociodemographics. RESULTS Compared with controls, at 12-months postintervention (8th grade spring), youth in Salud-100 report lower sexual risks (touching, AOR 1.46, CI 1.19-0.84, p < .001; lifetime sex ( AOR 0.74, CI 0.61-0.90, p < .01); and sex intentions ( AOR 0.78, CI 0.63-0.96, p < .05). Consistent with a dose-response, Salud-50 results are between those from Salud-100 and control schools. CONCLUSIONS Salud y éxito is an effective parenting intervention that can augment school-based health and sexuality education and help Latino parents support their children during early adolescence. [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]

ABSTRACT Background As many delirium manifestations (e.g., hallucinations or fears) are linked to patients' experiences and personality traits, it is suggested that interventions should be tailored to optimize its management. The inclusion of family members, as part of an intervention, has recently emerged as a solution to developing individualised patient care, but has never been assessed in post-cardiac surgery intensive care unit where almost half of patients will present with delirium. Aims To assess the feasibility, acceptability and preliminary efficacy of an nursing intervention involving family caregivers ( FC) in delirium management following cardiac surgery. Design A randomized pilot study. Methods A total of 30 patient/ FC dyads were recruited and randomized to usual care ( n = 14) or intervention ( n = 16). The intervention was based on the Human Caring Theory, a mentoring model, and sources informing self-efficacy. It comprised seven planned encounters spread over 3 days between an intervention nurse and the FC, each including a 30-min visit at the patient's bedside. During this bedside visit, the FC used delirium management strategies, e.g. reorient the person with delirium. The primary indicator of acceptability was to obtain consent from 75% of approached FCs. The preliminary effect of the intervention on patient outcomes was assessed on (1) delirium severity using the Delirium Index, (2) occurrence of complications, such as falls, (3) length of postoperative hospital stay and (4) psycho-functional recovery using the Sickness Impact Profile. The preliminary effect on FC outcomes was assessed on FC anxiety and self-efficacy. Data were analysed using descriptive statistics, ANCOVAs and logistic regressions. Results The primary indicator of obtaining consent from FC was achieved (77%). Of the 14 dyads, thirteen (93%) dyads received all seven encounters planned in the experimental intervention. Intervention group patients presented better psycho-functional recovery scores when compared with control group patients ( p = 0·01). Mean delirium severity scores showed similar trajectories on days 1, 2 and 3 in both groups. Conclusion The mentoring intervention was acceptable and feasible and shows promising results in improving patients and FC outcomes. Relevance to clinical practice Nurses should involve, if willing, FC to participate in activities that optimise patient well-being FC to use recognized delirium management strategies like reorientation and reassurance. [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]

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

Aims To determine if a low-intensity, clinic-integrated behavioural intervention reduced the incidence of hypoglycaemic events in children with Type 1 diabetes. Methods A total of 390 families with children with Type 1 diabetes were enrolled in a 2-year, randomized clinical trial of a behavioural intervention. The intervention was designed to improve diabetes management practices by targeting the family's diabetes problem-solving skills. Hypoglycaemic events were categorized in two groups: those treated by oral ingestion and those treated by parenteral therapy. Events were self-reported by participants at each clinic visit, which occurred approximately every 3-4 months. Analyses included two-sample t-tests, the mean cumulative function test, and the Cox proportional hazards model for recurrent events to compare the incidence between groups. Results Across the entire 2-year study period, the incidence of hypoglycaemic events treated by oral ingestion of glucose-rich foods and events requiring parenteral therapy did not significantly differ between study conditions; however, during the second year of participant enrolment, the incidence of events treated by oral ingestion in the intervention group was 13.6 per 100 person-years compared with 27.3 per 100 patient-years in the control group ( P = 0.02). The hazard ratio of these events during the second year was 0.49 (95% CI 0.27-0.90; P = 0.02). Conclusions Our findings suggest the need for a long-term (> 1 year) focus on the implementation of interventions targeting diabetes management in young people. Behavioural interventions targeting problem-solving skills could be considered as practical, non-pharmacological strategies to reduce hypoglycaemia in adolescents with Type 1 diabetes. [ABSTRACT FROM AUTHOR]