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

Background: Learning which letters correspond to which speech sounds is fundamental for learning to read. Based on previous experimental studies, we developed a serious game aiming to boost letter‐speech sound (L‐SS) correspondences in a motivational game environment. Objectives: The goal of this study was to determine the efficacy of this game in training L‐SS correspondences in pre‐readers. Additionally, an extended version of the game was developed given the importance of handwriting in audio‐visual integration. We established whether including a motoric component in the game boosted the letter‐speech sound training on top of the effect of the game without the motoric component. Methods: One‐hundred forty‐five kindergartners were randomly allocated to play either the standard audio‐visual version of the game, the motoric version or a control math game. All children were pre‐ and post‐tested on L‐SS knowledge and reading accuracy. Results and conclusions: We found that playing the game enhanced pre‐readers' L‐SS knowledge, but not reading accuracy, after a short, intensive intervention period of 3 weeks. However, children who played the motoric version of the game did not differ significantly from either the standard or the control condition. Implications: This game was efficient in training L‐SS correspondences in pre‐readers. These results suggest that this game might be useful as a preventive evidence‐based intervention for at‐risk children in kindergarten who might benefit from a head start before learning how to read. Future studies are needed to examine whether a longer intervention period results in L‐SS knowledge being translated into reading skills. Lay Description: What is already known about this topic: Automatised and fluent reading requires much exposure and practice, but intensive teacher support for all at‐risk readers is economically and practically unfeasibleHandwriting movement likely to enhance coupling of auditory and visual informationOne way to provide high exposure is with game‐based interventionsLack of studies examining the efficacy of these interventions What this paper adds: Serious game enhances letter‐speech sound knowledge in pre‐readers after 3 weeks of intensive interventionThis effect did not transfer to reading performanceNo additional effect of the handwriting movement, possibly due to the short intervention periodIn‐game measures slightly mediated intervention progress Implications for practice and/or policy: Growing evidence of game‐based interventions as promising tools to support reading developmentGame can possibly serve as evidence‐based intervention for at‐risk children in kindergarten who might benefit from a head start before learning how to read [ABSTRACT FROM AUTHOR]

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

Objectives To better understand the effectiveness of xylitol in caries prevention in adults and to attempt improved clinical trial efficiency. Methods As part of the Xylitol for Adult Caries Trial (X- ACT), non cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 g/day of xylitol, consumed by dissolving in the mouth five 1 g lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21-80, with complete data for four dental examinations, were selected from the 691 randomized into the 3-year trial, conducted at three sites. Acceptable inter- and intra-examiner reliability before and during the trial was quantified using the kappa statistic. Results The mean annualized noncavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically nonsignificant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit. Conclusions There was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non cavitated plus cavitated lesions were assessed. This conformed to the X- ACT trial result assessing cavitated lesions. Including non cavitated lesion assessment in this full-scale, placebo-controlled, multisite, randomized, double-blinded clinical trial in adults experiencing dental caries did not achieve added trial efficiency or demonstrate practical benefit of xylitol. Trial Registration: ClinicalTrials.Gov NCT00393055. [ABSTRACT FROM AUTHOR]

Background Modifying the consistency of food and drink is a strategy commonly used in the management of dysphagia for people with intellectual disabilities ( ID). People with ID often depend on others for the preparation of food and drink and therefore depend on those caregivers achieving the correct consistency to keep them safe and avoid discomfort during mealtimes. Clinical experience and prior research have demonstrated that although training can improve modification, carers often find modification difficult and potentially stressful and recommend additional support for carers. Fluid consistency is often modified through the addition of powdered thickener. This study investigates the efficacy of typical training and use of consistency guides, the Thickness Indicator Model ( TIM) tubes, in helping carers to modify fluids accurately. Method A 3 × 3 pre-post experimental design with a control group was employed to compare the observed accuracy of modification across three groups and at three time points (pre-intervention baseline, immediately post-training intervention and 3-10 months post-training). Sixty-two paid carers who supported people with ID were recruited to participate in the study and each was randomly allocated to one of the three groups: a control group given written guidance only, a group who received typical training and written guidance and a group who received training, written guidance and the TIM tubes. Results & Conclusions Typical training resulted in significantly greater carer accuracy in modifying fluid consistencies when compared with written guidance alone. Use of the TIM tubes also significantly improved accuracy in the modification of drinks compared with the group who modified with the aid of written guidance alone. At 3-10-month follow-up only the group who received typical training alongside the TIM tubes were significantly more accurate than the Written Guidance group. Further research is warranted to ascertain the effectiveness of the training and the utility of the TIM tubes in improving accuracy over a longer time scale and in individuals' usual living environments. [ABSTRACT FROM AUTHOR]

Previous research has shown clinical effectiveness of dermal substitution; however, in burn wounds, only limited effect has been shown. A problem in burn wounds is the reduced take of the autograft, when the substitute and graft are applied in one procedure. Recently, application of topical negative pressure ( TNP) was shown to improve graft take. The aim of this study was to investigate if application of a dermal substitute in combination with TNP improves scar quality after burns. In a four-armed multicenter randomized controlled trial, a split-skin graft with or without a dermal substitute and with or without TNP was compared in patients with deep dermal or full-thickness burns requiring skin transplantation. Graft take and rate of wound epithelialization were evaluated. Three and 12 months postoperatively, scar parameters were measured. The results of 86 patients showed that graft take and epithelialization did not reveal significant differences. Significantly fewer wounds in the TNP group showed postoperative contamination, compared to other groups. Highest elasticity was measured in scars treated with the substitute and TNP, which was significantly better compared to scars treated with the substitute alone. Concluding, this randomized controlled trial shows the effectiveness of dermal substitution combined with TNP in burns, based on extensive wound and scar measurements. [ABSTRACT FROM AUTHOR]

International Journal of Paediatric Dentistry 2012; 22: 169-179 Background. Mexican-American children have a higher caries prevalence than the US average. The Mothers and Youth Access (MAYA) study was a randomized clinical trial initiated to address this problem. Aim. Comparison of the efficacy of two prevention interventions in reducing early childhood caries (ECC). Design. All 361 randomized mother-child dyads received oral health counselling. Beginning at 4 months postpartum, intervention mothers received chlorhexidine (CHX) mouthrinse for 3 months beginning 4 months postpartum and children received fluoride varnish (FV) every 6 months from age 12-36 months. Control group children received FV if precavitated lesions developed. Salivary mutans streptococci (MS) and lactobacilli were assessed. Results. No significant difference in children's 36-month caries incidence between groups; 34% in each group developed caries [( d2+fs) > 0]. About half of control group developed precavitated lesions and received therapeutic FV. Maternal MS levels declined during CHX use, but increased when discontinued. Conclusions. Maternal postpartum CHX regimen, oral health counselling and preventive child FV applications were not more efficacious than maternal counselling with child therapeutic FV for precavitated lesions for ECC prevention. FV for young children with brief maternal CHX use and oral health counselling may need to be combined with additional or longer-term therapies to significantly reduce ECC in high-risk populations. [ABSTRACT FROM AUTHOR]

Background The Cochrane Collaboration is strongly encouraging the use of a newly developed tool, the Cochrane Collaboration Risk of Bias Tool (CCRBT), for all review groups. However, the psychometric properties of this tool to date have yet to be described. Thus, the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity, in comparison with the Effective Public Health Practice Project Quality Assessment Tool (EPHPP). Methods Both tools were used to assess the methodological quality of 20 randomized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain. Each study assessment was completed independently by two reviewers using each tool. We analysed the inter-rater reliability of each tool's individual domains, as well as final grade assigned to each study. Results The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade. In contrast, the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade. Of interest, no agreement between the two tools was evident in their final grade assigned to each study. Although both tools were developed to assess 'quality of the evidence', they appear to measure different constructs. Conclusions Both tools performed quite differently when evaluating the risk of bias or methodological quality of studies in knowledge translation interventions for cancer pain. The newly introduced CCRBT assigned these studies a higher risk of bias. Its psychometric properties need to be more thoroughly validated, in a range of research fields, to understand fully how to interpret results from its application. [ABSTRACT FROM AUTHOR]

Background: Telerehabilitation may be a feasible solution to the current problems faced by people with Parkinson's disease in accessing speech pathology services. Aim: To investigate the validity and reliability of online delivery of the Lee Silverman Voice Treatment (LSVT®) for the speech and voice disorder associated with Parkinson's disease. Method & Procedures: Thirty-four participants with Parkinson's disease and mild-to-moderate hypokinetic dysarthria took part in the randomized controlled non-inferiority laboratory trial and received the LSVT® in either the online or the face-to-face environment. Online sessions were conducted via two personal computer-based videoconferencing systems with real-time and store-and-forward capabilities operating on a 128 kbit/s Internet connection. Participants were assessed pre- and post-treatment on acoustic measures of mean vocal sound pressure level, phonation time, maximum fundamental frequency range, and perceptual measures of voice, articulatory precision and speech intelligibility. Outcomes & Results: Non-inferiority of the online LSVT® modality was confirmed for the primary outcome measure of mean change in sound pressure level on a monologue task. Additionally, non-significant main effects for the LSVT® environment, dysarthria severity, and interaction effects were obtained for all outcomes measures. Significant improvements following the LSVT® were also noted on the majority of measures. The LSVT® was successfully delivered online, although some networking difficulties were encountered on a few occasions. High participant satisfaction was reported overall. Conclusions & Implications: Online treatment for hypokinetic dysarthria associated with Parkinson's disease appears to be clinically valid and reliable. Suggestions for future research are outlined. [ABSTRACT FROM AUTHOR]