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

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

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

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

Background: Very young children from lower socioeconomic status (SES) backgrounds often show poorer language development. Whilst there have been attempts to provide early intervention programmes, these sometimes miss the most disadvantaged groups. Aims: This report presents preliminary feasibility and effectiveness data for a novel language intervention designed for parents of toddlers in the United Kingdom. Methods and Procedures: In total, 43 UK families of 2–4‐year‐olds were recruited to the study, half of whom completed an 8‐week course (Tots Talking) focussed on parent interaction, and half of whom acted as wait‐list controls. Results and Outcomes: Results suggest that such programmes are feasible for families with 86% staying in the intervention. In addition, greater changes in underlying communication skills such as joint attention and gesture were evident compared to wait‐list controls. Conclusions and Implications: We conclude that pre‐verbal skills may be more important to measure as initial outcomes than language or vocabulary change in this population. What This Paper Adds: What is already known on the subject: Children from lower socioeconomic status (SES) backgrounds are at higher risk of communication difficulties and there is a need for community intervention programmes for very young children. What this study adds: This study suggests that such programmes can be feasible and effective, but that very early/basic communicative skills (such as joint attention) may be boosted first rather than language or vocabulary. What are the clinical implications of this work?: Children's centres and other community services could feasibly run short parent facing courses emphasising contingent communication in low SES families and other diverse groups. These may be more successful run with younger preschoolers. Joint attention may be a better focus of intervention before expecting vocabulary or language change. Community health professionals may find this information useful in referring and supporting families in need. [ABSTRACT FROM AUTHOR]

Purpose. To examine whether cognitive behaviour therapy (CBT) reduces psychopathology in patients with schizophrenia more effectively than the use of non-cognitive psychotherapies. Method. Systematic review and meta-analysis of the literature was performed. All Randomized Controlled Trials meeting the inclusion criteria were analysed using RevMan software. This design was used to maximize power and study efficacy. Medline, PsycINFO, and Embase were searched using free-text keywords to identify potential papers. Nine were included in the final meta-analysis. Change in psychopathology at the end of therapy was the end point investigated. A random effects model was used to assess the standard mean difference between the CBT and supportive control groups. Results. Meta-analysis of CBT versus supportive therapy did not find significant differences between the therapy groups at the end of treatment in respect of psychopathology. There was no evidence of publication bias. Post hoc power analysis using the Z test ruled out type one error. Conclusions. Theoretically based CBT therapies, although proving effective, may not out perform more accessible and simpler forms of therapy for patients with schizophrenia in reducing psychopathology. Consideration of supportive therapy should be made for patients with psychotic mental disorder. Practitioner Points CBT may not be the psychotherapeutic treatment of choice to alleviate the phenomenology of Schizophrenia., It may be valuable trialling simple supportive therapies prior to implementing more costly and complex cognitive therapies., This review, like the Cochrane review and others, does not suggest CBT in psychosis is not effective, simply that it dose not outperform supportive therapy in effecting change in phenomenology. [ABSTRACT FROM AUTHOR]

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

Objective: To assess methods, quality and outcomes of systematic reviews (SRs) conducted to evaluate the effectiveness of root coverage (RC) procedures in the treatment of recession-type defects (RTD). Methods: MEDLINE and EMBASE were searched up to and including April 2010 to identify SRs investigating the effectiveness/efficacy of surgical interventions for the treatment of patients with RTD. Searching was conducted independently by two reviewers, and data extraction was based on the methodological criteria applied and on the effects of interventions reported by each SR. The checklist proposed by Glenny and colleagues, the Overview Quality Assessment Questionnaire and the "Assessment of Multiple systematic Reviews", instrument were used to assess the quality of SRs. Additionally, the methodological criteria applied by included reviews were compared with those proposed by the Cochrane Collaboration. Results: Search strategy identified 716 potentially eligible articles, of which 12 papers regarding 10 SRs were included in the study. Results from different SRs showed that subepithelial connective tissue grafts associated or not to coronally advanced flaps can be used to reduce recession depth and improve the width of keratinized tissue. All quality assessment tools showed that most of the SRs were of good methodological quality, but they also highlighted key points that could be improved in future reviews. Only two SRs followed in full the guidelines proposed by the Cochrane Collaboration. Conclusions: All SRs agree that RC may be anticipated by different surgical procedures. However, differences in the methodological quality between reviews were quite evident, and thus making a clear indication that there is a need of standardization of the methods that will be applied by future SRs. As a result, a standardized checklist for reporting SRs was proposed by the authors. [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]

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

Background Colorectal cancer (CRC) is one of the most common types of cancer in European countries and associated with a high mortality rate. A 16% relative risk reduction (RRR) of mortality was found in a meta-analysis based on four randomized controlled trials (RCT) on CRC screening. The aim of this paper was to scrutinize these trials for potential biases and assess their influence on the screening trials. Methods The four RCTs were reviewed based on the principles of 'Critical Appraisal of the Medical Literature'. Principal investigators of the four RCTs were contacted to clarify uncertainties in their study. Data were collected from The Danish Data Archives. Authors of the Cochrane review were contacted. Results Six biases were identified, of which five favour screening. Three of the biases identified were specific to CRC screening: type of diagnostic method, place of surgery and diagnostic delay. Conclusion The 16% RRR in CRC mortality found in the updated Cochrane review's meta-analysis is overestimated. [ABSTRACT FROM AUTHOR]

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

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

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

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

Objectives To assess the efficacy of comprehensive geriatric assessment ( CGA) in prevention of delirium after hip fracture. Design Systematic review and metaanalysis. Setting Ward based models on geriatrics wards and visiting team based models on orthopaedics wards were included. Participants Four trials (three European, one U.S.; 973 participants) were identified. Two assessed ward-based, and two assessed team-based interventions. Measurements MEDLINE, EMBASE, CINAHL and Psyc INFO databases; Clinicaltrials.gov; and the Central Register of Controlled Trials were searched. Reference lists from full-text articles were reviewed. Incidence of delirium was the primary outcome. Length of stay, delirium severity, institutionalization, long-term cognition and mortality were predefined secondary outcomes. Duration of delirium was included as a post hoc outcome. Results There was a significant reduction in delirium overall (relative risk ( RR) = 0.81, 95% confidence interval ( CI) = 0.69-0.94) in the intervention group. Post hoc subgroup analysis found this effect to be preserved in the team-based intervention group ( RR = 0.77, 95% CI = 0.61-0.98) but not the ward-based group. No significant effect was observed on any secondary outcome. Conclusion There was a reduction in the incidence of delirium after hip fracture with CGA. This is in keeping with results of non-randomized controlled trials and trials in other populations. Team-based interventions appeared superior in contrast to the Ellis CGA paper, but it is likely that heterogeneity in interventions and population studied affected this. [ABSTRACT FROM AUTHOR]

Background: The safety of waterbirth is contested because of the lack of evidence from randomized trials and conflicting results. This research assessed the feasibility of a prospective study of waterbirth (trial or cohort). Methods: We conducted a prospective cohort study at an Australian maternity hospital. Eligible women with uncomplicated pregnancies at 36 weeks of gestation were recruited and surveyed about their willingness for randomization. The primary midwife assessed waterbirth eligibility and intention on admission in labor, and onset of second stage. Primary outcomes measured feasibility. Intention‐to‐treat analysis, and per‐protocol analysis, compared clinical outcomes of women and their babies who intended waterbirth and nonwaterbirth at onset of second stage. Results: 1260 participants were recruited; 15% (n = 188) agreed to randomization in a future trial. 550 women were analyzed by intention‐to‐treat analysis: 351 (waterbirth) and 199 (nonwaterbirth). In per‐protocol analysis, 14% (n = 48) were excluded. Women in the waterbirth group were less likely to have amniotomy and more likely to have water immersion and physiological third stage. There were no differences in other measures of maternal morbidity. There were no significant differences between groups for serious neonatal morbidity; four cord avulsions occurred in the waterbirth group with none in the landbirth group. An RCT would need approximately 6000 women to be approached at onset of second stage. Conclusions: A randomized trial of waterbirth compared with nonwaterbirth, powered to detect a difference in serious neonatal morbidity, is unlikely to be feasible. A powered prospective study with intention‐to‐treat analysis at onset of second stage is feasible. [ABSTRACT FROM AUTHOR]

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

Aims Sudden death is a leading cause of mortality in heart failure with reduced ejection fraction (HFrEF). In PARADIGM-HF, sacubitril/valsartan reduced the incidence of sudden death. The purpose of this post hoc study was to analyse the effect of sacubitril/valsartan, compared to enalapril, on the incidence of ventricular arrhythmias. Methods and results Adverse event reports related to ventricular arrhythmias were examined in PARADIGM-HF. The effect of randomized treatment on two arrhythmia outcomes was analysed: ventricular arrhythmias and the composite of a ventricular arrhythmia, implantable cardioverter defibrillator (ICD) shock or resuscitated cardiac arrest. The risk of death related to a ventricular arrhythmia was examined in time-updated models. The interaction between heart failure aetiology, or baseline ICD/cardiac resynchronization therapy-defibrillator (CRT-D) use, and the effect of sacubitril/valsartan was analysed. Of the 8399 participants, 333 (4.0%) reported a ventricular arrhythmia and 372 (4.4%) the composite arrhythmia outcome. Ventricular arrhythmias were associated with higher mortality. Compared with enalapril, sacubitril/valsartan reduced the risk of a ventricular arrhythmia (hazard ratio [HR] 0.76, 95% confidence interval [CI] 0.62-0.95; p = 0.015) and the composite arrhythmia outcome (HR 0.79, 95% CI 0.65-0.97; p = 0.025). The treatment effect was maintained after adjustment and accounting for the competing risk of death. Baseline ICD/CRT-D use did not modify the effect of sacubitril/valsartan, but aetiology did: HR in patients with an ischaemic aetiology 0.93 (95% CI 0.71-1.21) versus 0.53 (95% CI 0.37-0.78) in those without an ischaemic aetiology (p for interaction = 0.020). Conclusions Sacubitril/valsartan reduced the incidence of investigator-reported ventricular arrhythmias in patients with HFrEF. This effect may have been greater in patients with a non-ischaemic aetiology. [ABSTRACT FROM AUTHOR]

Beneficial acute effects of resistance exercise on cognitive functions may be modified by exercise intensity or by habitual physical activity. Twenty‐six participants (9 female and 17 male; 25.5 ± 3.4 years) completed four resistance exercise interventions in a randomized order on separate days (≥48 h washout). The intensities were set at 60%, 75%, and 90% of the one repetition maximum (1RM). Three interventions had matched workloads (equal resistance*nrepetitions). One intervention applied 75% of the 1RM and a 50% reduced workload (resistance*nrepetitions = 50%). Cognitive attention (Trail Making Test A—TMTA), task switching (Trail Making Test B—TMTB), and working memory (Digit Reading Spans Backward) were assessed before and immediately after exercise. Habitual activity was assessed as MET hours per week using the International Physical Activity Questionnaire. TMTB time to completion was significantly shorter after exercise with an intensity of 60% 1RM and 75% 1RM and 100% workload. Friedman test indicated a significant effect of exercise intensity in favor of 60% 1RM. TMTA performance was significantly shorter after exercise with an intensity of 60% 1RM, 90% 1RM, and 75% 1RM (50% workload). Habitual activity with vigorous intensity correlated positively with the baseline TMTB and Digit Span Forward performance but not with pre‐ to post‐intervention changes. Task switching, based on working memory, mental flexibility, and inhibition, was beneficially influenced by acute exercise with moderate intensity whereas attention performance was increased after exercise with moderate and vigorous intensity. The effect of regular activity had no impact on acute exercise effects. [ABSTRACT FROM AUTHOR]

Homestead food production (HFP) programmes improve the availability of vegetables by providing training in growing nutrient‐dense crops. In rural Tanzania, most foods consumed are carbohydrate‐rich staples with low micronutrient concentrations. This cluster‐randomized controlled trial investigated whether women growing home gardens have higher dietary diversity, household food security or probability of consuming nutrient‐rich food groups than women in a control group. We enrolled 1,006 women of reproductive age in 10 villages in Pwani Region in eastern Tanzania, split between intervention (INT) and control (CON) groups. INT received (a) agricultural training and inputs to promote HFP and dietary diversity and (b) nutrition and public health counselling from agricultural extension workers and community health workers. CON received standard services provided by agriculture and health workers. Results were analysed using linear regression models with propensity weighting adjusting for individual‐level confounders and differential loss to follow up. Women in INT consumed 0.50 (95% CI [0.20, 0.80], p = 0.001) more food groups per day than women in CON. Women in INT were also 14 percentage points (95% CI [6, 22], p = 0.001) more likely to consume at least five food groups per day, and INT households were 6 percentage points (95% CI [−13, 0], p = 0.059) less likely to experience moderate‐to‐severe food insecurity compared with CON. This home gardening intervention had positive effects on diet quality and food security after 1 year. Future research should explore whether impact is sustained over time as well as the effects of home garden interventions on additional measures of nutritional status. [ABSTRACT FROM AUTHOR]

BACKGROUND Early mobilization of patients in intensive care units (ICUs) improves patient recovery, but implementation remains challenging. Protocols may enhance the rate of out‐of‐bed mobilizations. AIM: To evaluate the effect of implementing a protocol for early mobilization on the rate of out‐of‐bed mobilizations and other outcomes of ICU patients. STUDY DESIGN Multicentre, stepped‐wedge, cluster‐randomized pilot study. METHODS: After a control period, five ICUs were allocated to the implementation of an inter‐professional protocol for early mobilization in a randomized, monthly order. Mobilization of ICU patients was evaluated by monthly 1‐day point prevalence surveys using the ICU Mobility Scale. The primary outcome was the percentage of patients mobilized out of bed, defined as level 3 on the ICU Mobility Scale (sitting on edge of bed) or higher. Secondary outcomes were mechanical ventilation, delirium and ICU‐ and hospital‐days, as well as unwanted safety events. RESULTS: Out‐of‐bed mobilizations increased non‐significantly from 36·2% (n = 55) of 152 patients during the control period to 45·8% (n = 55) of 120 patients during the intervention period (difference 9·6%; 95% confidence interval −2·1 to 21·3%). Of 55 mobilized patients per group, more patients were mobilized once per day during the intervention period (intervention: n = 41 versus control: n = 23 patients). Multiple daily mobilizations decreased (control: n = 32 control versus intervention: n = 14 patients). Secondary outcomes, such as days with mechanical ventilation, delirium and in ICU and hospital, did not significantly differ. Adherence to the protocol was >90%; unwanted safety events were rare. CONCLUSIONS: Implementing a protocol for early mobilization of ICU patients showed a trend towards more patients being mobilized. Without additional staff in participating ICUs, a significant increase in ICU mobilizations was not to be anticipated. More research should address whether more staff would increase the number of frequent mobilizations and if this is relevant to outcomes. RELEVANCE TO CLINICAL PRACTICE: Implementing inter‐professional protocols for mobilization is feasible and safe and may contribute to an increase of ICU patients mobilized out of bed. [ABSTRACT FROM AUTHOR]

Background: The objective of this trial is to optimize the transmuscular quadratus lumborum (TQL) block, by investigating the minimal effective volume (MEV90 ) of ropivacaine 0.75% for single-shot TQL block in percutaneous nephrolithotomy (PNL) patients.Methods: This double-blind, randomized and controlled dose-finding trial is based on a biased coin up-and-down sequential design, where the volume of local anaesthetic administered to each patient depends on the response from the previous one. Investigating the TQL block, the first patient recruited receives 20 ml ropivacaine 0.75% preoperatively. In case of block failure, the next patient will receive the same volume with an increment of 2 ml. Given a successful block for the first patient, the next patient will be randomized to either a lower volume (previous volume with a reduction of 2 ml), or the same volume as the previous patient. The respective probabilities being b = 0.11 for a reduced volume and 1-b = 0.89 for the same volume. Block success is defined as patient reported pain score numeric rated scale (NRS) ≤3 (0-10/10) 30 minutes after arrival in the post anaesthesia care unit (PACU). The NRS pain score is our primary and only outcome for block success. A minimum of 25 eligible patients are needed to achieve precise estimation of MEV90 with narrow 95% confidence intervals derived by bootstrapping.Discussion: Recruiting will begin June 2020 and is expected to finish November 2020. Data analysis will be performed at interims during and after the study. Results will be published in an international peer-reviewed medical journal. [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: The measurement and interpretation of patient experience is a distinct dimension of health care quality. The Midwives @ New Group practice Options (M@NGO) randomized control trial of caseload midwifery compared with standard care among women regardless of risk reported both clinical and cost benefits. This study reports participants' perceptions of the quality of antenatal care within caseload midwifery, compared with standard care for women of any risk within that trial. Methods: A trial conducted at two Australian tertiary hospitals randomly assigned participants (1:1) to caseload midwifery or standard care regardless of risk. Women were sent an 89‐question survey at 6 weeks postpartum that included 12 questions relating to pregnancy care. Ten survey questions (including 7‐point Likert scales) were analyzed by intention to treat and illustrated by participant quotes from two free‐text open‐response items. Results: From the 1748 women recruited to the trial, 58% (n = 1017) completed the 6‐week survey. Of those allocated to caseload midwifery, 66% (n = 573) responded, compared with 51% (n = 444) of those allocated to standard care. The survey found women allocated to caseload midwifery perceived a higher level of quality care across every antenatal measure. Notably, those women with identified risk factors reported higher levels of emotional support (aOR 2.52 [95% CI 1.87‐3.39]), quality care (2.94 [2.28‐3.79]), and feeling actively involved in decision‐making (3.21 [2.35‐4.37]). Conclusions: Results from the study show that in addition to the benefits to clinical care and cost demonstrated in the M@NGO trial, caseload midwifery outperforms standard care in perceived quality of pregnancy care regardless of risk. [ABSTRACT FROM AUTHOR]

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

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

Background: Migraine has a substantial impact on daily living, affecting productivity and quality of life for patients and their families. Patients frequently discontinue preventive medications in part because of a delay in headache and symptom relief due to the long dose titration procedures necessary for some migraine preventives. Objective: To evaluate the efficacy of fremanezumab, a selective monoclonal CGRP ligand antibody, during the first 3 weeks of therapy in patients with high‐frequency episodic migraine (HFEM) to relieve migraine headaches and associated symptoms and to reduce use of acute migraine medications. Methods: In a multicenter, randomized, double‐blind, placebo‐controlled, phase 2 study, patients with HFEM who met inclusion criteria and were 80% compliant with daily headache diary entry were randomized and treated once every 28 days for 3 months with either placebo or fremanezumab 225 or 675 mg. Compared to placebo, both doses of fremanezumab significantly reduced the primary endpoint of the HFEM study, change in the number of migraine days in month 3 relative to baseline. Herein, we performed post‐hoc analyses to assess the efficacy of each dose during the first 3 weeks of treatment to reduce migraine headache parameters, associated migraine symptoms, and the consumption of acute migraine medications. Results: The sample consisted of 297 study participants. Compared to placebo, decreases in migraine days were seen during the first week of therapy for both fremanezumab doses with least square mean (LSM) differences between fremanezumab 225 mg and placebo of −0.93 (95% CI: −1.36, −0.49) and between 675 mg dose and placebo of −1.02 (95% CI: −1.46, −0.58), both P < .0001. This benefit was maintained through the second week of therapy for the 225 and 675 mg doses, respectively, (−0.76 (95% CI: −1.11, −0.40) P < .0001, −.79 (95% CI: −1.15, −0.44) P < .0001) and the third week of therapy (−0.64 (95% CI: −0.97, −0.30) P = .0003 and −0.64 (95% CI: −0.98, −0.30) P = .0003). Likewise in the first week, patients recorded reductions in associated migraine symptoms such as nausea, vomiting, photophobia, and phonophobia, which continued through weeks 2 and 3. There were also reductions in days with acute medication use to treat migraine for the 225 and 675 mg fremanezumab doses compared to placebo. In the first week, LSM differences between 225 mg and placebo were −1.02 (95% CI: −1.39, −0.64) and between 675 mg and placebo were −1.06 (95% CI: −1.39, −0.64) P < .0001); for the second and third weeks (−1.01 (95% CI: −1.14, −0.55) P < .0001; −.90 (95% CI: −1.04, −0.44) P < .0001; −.91 (95% CI: −0.92, −0.34) P < .0001; and −.83 (95% CI: −0.84, −0.26) P = .0002), respectively. Conclusion: Fremanezumab treatment resulted in a rapid preventive response in patients with HFEM, with reductions seen in several headache parameters and migraine symptoms within the first week after therapy initiation and continuing during the second and third weeks. Patients also were able to rapidly reduce their use of acute medications to treat migraine attacks. The trial is registered at Clinicaltrials.gov as NCT02025556. [ABSTRACT FROM AUTHOR]

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

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

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]

The article discusses the correspondence between the author of the article regarding randomised controlled trial comparing the effect of peri-operative ketamine with dexamethasone on markers of inflammation and editor regarding the effect sizes of each marker. It mentions difference in mean C-reactive protein (CRP) concentration between the ketamine and control group is 5 unit. It also mentions effect size estimate may be considered as being similar to a confidence interval.

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]

To perform a meta-analysis of published literature to assess the role of high-concentration inspired oxygen in reducing the incidence of surgical site infections ( SSIs) following all types of surgery, a comprehensive search for published randomized controlled trials ( RCTs) comparing high- with low-concentration inspired oxygen for SSIs was performed. The related data were extracted by two independent authors. The fixed and random effects methods were used to combine data. Twelve RCTs involving 6750 patients were included. Our pooled result found that no significant difference in the incidence of SSIs was observed between the two groups, but there was high statistic heterogeneity across the studies [risk ratio ( RR): 0·91; 95% confidence interval ( CI): 0·72-1·14; P = 0·40; I2 = 54%]. The sensitivity analysis revealed the superiority of high-concentration oxygen in decreasing the SSI rate (RR: 0·86; 95% CI: 0·75-0·98; P = 0·02). Moreover, a subgroup analysis of studies with intestinal tract surgery showed that patients experienced less SSI when high-concentration inspired oxygen was administrated (RR: 0·53; 95% CI: 0·37-0·74; P = 0·0003). Our study provided no direct support for high-concentration inspired oxygen in reducing the incidence of SSIs in patients undergoing all types of surgery. [ABSTRACT FROM AUTHOR]

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

Strategies for preventing undernutrition comprise a range of interventions, including education, provision of complementary food and cash transfer. Here, we compared monthly distributions of two different lipid‐based nutrient supplements (LNS), large‐quantity LNS (LNS‐LQ) and medium‐quantity LNS (LNS‐MQ) for 15 months on prevention of undernutrition among children 6 to 23 months. Both groups also received cash transfer for the first 5 months of the intervention. We conducted a prospective intervention study in Maradi, Niger, between August 2011 and October 2012. Six and 11 villages were randomly allocated to LNS‐LQ/Cash and LNS‐MQ/Cash, respectively. Children measuring 60–80 cm were enrolled in the respective groups and followed up monthly. Poisson regression was used to assess differences between interventions and adjust for baseline characteristics, intervention periods and child‐feeding practices. The analysis included 2586 children (1081 in the LNS‐LQ/Cash group and 1505 in the LNS‐MQ/Cash group). This study suggests that provision of LNS‐LQ (reference) or LNS‐MQ had, overall, similar effect on incidence of severe acute malnutrition (RR = 0.97; 95% CI: 0.67–1.40; P = 0.88), moderate acute malnutrition (RR = 1.20; 95% CI: 0.97–1.48; P = 0.08), severe stunting (RR = 0.94; 95% CI: 0.70–1.26; P = 0.69), moderate stunting (RR = 0.95; 95% CI: 0.76–1.19; P = 0.67) and mortality (RR = 0.83; 95% CI: 0.41–1.65; P = 0.59). Compared with LNS‐LQ, LNS‐MQ showed a greater protective effect on moderate acute malnutrition among children with good dietary adequacy: RR = 0.72; 95% CI: 0.56–0.94; P = 0.01. These results highlight the need to design context‐specific programmes. Provision of LNS‐LQ might be more appropriate when food insecurity is high, while when food security is better, distribution of LNS‐MQ might be more appropriate. [ABSTRACT FROM AUTHOR]

Aim To assess patient-reported outcome measures ( PROMs), aesthetics and stability of root coverage procedures from a previous 6-month RCT after 1 year. Material & Methods Forty-five patients (90 recessions) had received a coronally advanced flap ( CAF = control) only or a xenogeneic collagen matrix in addition ( CAF + CMX = test). Visual analogue scales ( VAS) and questionnaires were used for PROMs and the root coverage aesthetic score ( RES) for professional aesthetic evaluations. Results VAS scores (patient satisfaction) amounted to 8.58 ± 1.86 (test) versus 8.38 ± 2.46 (control). Six patients preferred CAF + CMX concerning surgical procedure and aesthetics, six preferred CAF and 29 were equally satisfied. RES was 7.85 ± 2.42 for the test group versus 7.34 ± 2.90 for the controls. Root coverage ( RC) was 76.28% for test and 75.05% for control defects. The mean increase in keratinized tissue width was higher in test (from 1.97 to 3.02 mm) than in controls (from 2.00 to 2.64 mm) ( p = 0.0413). Likewise, test sites showed more gain in gingival thickness (0.52 mm) than control sites (0.27 mm) ( p = 0.0023). Compared to 6 months, clinical outcomes were stable. Conclusions Results for PROMs, RES and RC did not significantly differ between treatment groups. Thickness and width of keratinized tissue were enhanced following CAF + CMX compared to CAF alone. [ABSTRACT FROM AUTHOR]

Objectives Mental ill-health has become a large health problem and it is important for caregivers to provide effective treatment alternatives. REGASSA is a randomized controlled study performed in primary care to study the effects of 12 weeks of Internet-based cognitive behaviour therapy ( ICBT) and physical exercise ( PE) compared with treatment as usual ( TAU) in patients with mild-to-moderate mental ill-health. The present study aimed to examine the results of these treatment alternatives on psychological functioning, stress, and sleep disturbances. Methods The study comprised 879 patients with mental ill-health taking part in the REGASSA study. Data were collected by Interactive Voice Response ( IVR), a computerized, automated telephone technique. The treatments were compared at baseline, twice during treatment, at the end of treatment and at three follow-ups after treatment. Measures used were the Outcome Questionnaire-45, the short versions of the Perceived Stress Scale, and the Karolinska Sleep Questionnaire. Results Linear mixed models showed that the patients in ICBT and PE had better results than in TAU on psychological functioning and sleep disturbances, p < .001 , with weak-to-moderate effect sizes. On stress there were no differences; all groups made improvements. Women had stronger effects than men. More patients recovered on psychological functioning ( OQ-45) in ICBT and PE than in TAU. Conclusions Internet-based cognitive behaviour therapy and PE proved to be effective treatment alternatives for patients with mild-to-moderate mental ill-health in improving psychological functioning, stress, and sleep disturbances and could be useful alternatives in primary care. Practitioner points Internet-based cognitive behaviour therapy and physical exercise proved to be effective treatment alternatives for mental ill-health patients in primary care., Automated techniques (Interactive Voice Response) could be useful for following treatment course in large groups of patients in the health care., It is important to use measures that capture different aspects of patients' health problems., The recruitment of participants was based on patients' interest and inclusion criteria which may have affect the generalizability. [ABSTRACT FROM AUTHOR]

Aim A split-mouth randomized clinical trial was carried out to assess the effectiveness of a school-based dental sealant ( SBDS) program for French children from low-income backgrounds within 3 years of follow-up. The secondary objectives were to determine the risk factors for the occurrence of new carious lesions ( ICDAS 3-6) on first permanent molars, to evaluate the effectiveness of the program according to risk factors and to assess sealant retention. Methods The study included 276 6- to 7-year old pupils (457 pairs of first permanent molars) from Nice. The sealing was performed in first- or second-grade children. The first permanent molars were randomized into two groups: One received resin-based sealant and the other formed a nontreatment group. Carious lesions ICDAS 3-6 on permanent and primary teeth, visible plaque, streptococcus mutans and/or lactobacillus counts were recorded at baseline to assess individual caries risk ( ICR). The putative confounders recorded at baseline were sex, grade level, and characteristics of first permanent molars. An intent-to-treat analysis was performed, where the study outcome was the occurrence of new carious lesions within 3 years of follow-up. Univariate and multivariate Cox proportional hazards models (hazard risk, HR) using the procedure PHREG with the option of Covsandwich were performed in SAS to assess the effectiveness of the SBDS program. Results At 3 years of follow-up, 228 children (378 tooth pairs) remained in the analysis. The survival analysis showed that first permanent molars that received sealants had 67% (adjusted HR: 0.33; 95% CI: 0.24-0.46) less risk of developing new carious lesions during all the follow-up than molars without sealant. In addition, children with carious lesions ICDAS 3-6 on permanent and primary teeth, that is, high ICR, had three times the risk of having a new carious lesion than others without, independently of the sealant treatment (adjusted HR: 3.00; 95% CI: 1.55-5.75). Effectiveness of the SBDS program at 3 years of follow-up depended on the presence of carious lesions ICDAS 3-6 ( HR in 173 children with carious lesions: 0.32; 95% CI: 0.23-0.46) at baseline ( HR in 103 children without carious lesions: 0.42; 95% CI: 0.16-1.12). Finally, the overall retention rate was 32.3%. Conclusion The effectiveness of the SBDS program was demonstrated in low socioeconomic areas. Selection of schoolchildren according to the presence of carious lesions ICDAS 3-6 should be considered in a SBDS program. [ABSTRACT FROM AUTHOR]

Aim The study tested the hypothesis that doctors using an insulin information checklist during simulated insulin initiation would impart more information regarding insulin use. Methods A total of 128 simulations were conducted. Doctors ( n = 64) were recruited from practitioners recently completing internship ( n = 19) and those established in primary care ( n = 45). Both groups of doctors were strata randomized to control ( n = 32) and intervention groups ( n = 32), so that each group contained equal numbers. Doctors in each group experienced two identical simulations of insulin initiation with an intervening period of 10 min. Doctors in the intervention arm were introduced to an insulin initiation checklist, which they reviewed independently and utilized in the second simulation. Trained assessors captured the provision of education in 21 predefined educational areas. Differences in the change of the total education provided between the first and second simulations were assessed using linear regression. Results The difference in the mean change of education provided between the first and second simulations within the 21 educational areas for the control and treatment groups was 9.7 [95% confidence interval ( CI): 8.8-11.1, P < 0.001] - an increase of 46.2%. The difference for the 15 areas relevant to pen use was 7.3 (95% CI: 6.2-8.4, P < 0.001) - an increase of 51.6%. Conclusions The checklist resulted in doctors providing significantly more education applicable to syringe and insulin pen routes of insulin administration during simulations. Further research is needed on the checklist's impact on healthcare professionals and patient outcomes in the clinical context. (Clinical Trials Registry No: NCT02266303) [ABSTRACT FROM AUTHOR]

Objectives To compare the use of sonic powered or manual toothbrush in patients with intellectual disability ( ID) in terms of plaque (PlI) and gingival ( GI) indices and adverse effects. Material and Methods Subjects with ID were recruited for this cluster-randomized, single blinded (examiner), 6-month clinical trial, comparing powered versus manual toothbrushing. Outcome variables included PlI and GI, evaluated at baseline and 3 months after supervised toothbrushing and after 3 additional months of unsupervised used. Clinical outcome variables were analysed by repeated measures ANCOVA considering time and group as factors and respective baseline values as covariates (generalized linear model). Results Sixty-four patients (34 male, mean age 34.5) in six clusters were included in the study. No statistically significant effect of toothbrushing group was observed for PlI or GI. A significant effect of time was identified ( p < 0.001) with mean reductions ranging 0.44-0.45 for PlI and 0.30-0.36 for GI from baseline to 3-6 months. No relevant adverse effect or technical problems were observed. Conclusion The tested sonic powered toothbrush was as effective and safe as the manual toothbrush. The use of powered or manual toothbrushes, together with fluoride toothpaste, may improve plaque and gingivitis levels, in patients with mild to limit ID. [ABSTRACT FROM AUTHOR]

Objective The primary objective of the TEENZ Study (NCT01211145) was to assess the efficacy of zolmitriptan nasal spray in the acute treatment of adolescent migraine patients (ages 12 to 17 years), as measured by the primary outcome variable of pain-free status at 2 hours post-treatment. Methods This randomized, double-blind, placebo-controlled, four-arm parallel group study compared zolmitriptan nasal spray with placebo in the treatment of a single episode of adolescent migraine. Patients completed a 30-day run-in period to treat a single migraine attack with single-blind placebo nasal spray. Eligible patients, who had not responded to placebo, were randomized to one of three zolmitriptan nasal spray doses (5, 2.5, or 0.5 mg) or placebo in a ratio of 5:3:3:5 according to a computer-generated randomization scheme. Patients completed diaries for 24 hours after treatment, recording headache pain scores, adverse events (AEs), and medications taken. Results In an interim futility analysis, zolmitriptan nasal spray doses of 0.5 and 2.5 mg were declared futile relative to placebo and further randomization to these treatment arms was discontinued. Of 1653 patients enrolled into the study, 855 patients failed to meet study eligibility criteria and were considered screen failures. The most common reason for screen failure was response to placebo challenge (325 patients [38.0%]). Of the 798 patients who were randomized to treatment, 721 (90.4%) completed the study period. Of these, 657 (82.3%) treated a migraine within the study period and contributed data for analysis. Zolmitriptan nasal spray 5 mg was significantly more effective than placebo in achieving pain-free status at 2 hours after treatment ( P < .001), with 30% of patients achieving pain-free status at 2 hours vs 17% of placebo-treated patients (OR 2.18; 95% CI 1.40, 3.39). Zolmitriptan nasal spray 5 mg was also more effective than placebo in achieving pain-free status at 3 and 4 hours post-treatment (45 vs 24%, and 56 vs 39%; both P < .001). Zolmitriptan nasal spray 5 mg was also more effective than placebo in achieving headache response at 2, 3, and 4 hours after treatment (51 vs 39%, 61 vs 48%, and 69 vs 57%, respectively; all P ≤ .011). Zolmitriptan nasal spray was well-tolerated at all doses. Dysgeusia was the most frequently reported AE, with greater frequencies reported in active treatment groups versus placebo. No serious AEs or AEs leading to discontinuation were reported. Most AEs were mild or moderate in severity, and consistent with the known profile of zolmitriptan in adult and adolescent populations. Conclusion Zolmitriptan nasal spray was well-tolerated in the acute treatment of adolescent (ages 12 to 17 years) migraine. Zolmitriptan 5 mg nasal spray demonstrated superior efficacy compared with placebo for the primary efficacy endpoint of pain-free status 2 hours after treatment and the efficacy of the 5 mg dose was supported by the majority of secondary efficacy endpoints. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate the effects of vitamin C and E supplementation on changes in muscle mass (lean mass and muscle thickness) and strength during 12 weeks of strength training in elderly men. Thirty-four elderly males (60-81 years) were randomized to either an antioxidant group (500 mg of vitamin C and 117.5 mg vitamin E before and after training) or a placebo group following the same strength training program (three sessions per week). Body composition was assessed with dual-energy X-ray absorptiometry and muscle thickness by ultrasound imaging. Muscle strength was measured as one-repetition maximum (1 RM). Total lean mass increased by 3.9% (95% confidence intervals: 3.0, 5.2) and 1.4% (0, 5.4) in the placebo and antioxidant groups, respectively, revealing larger gains in the placebo group ( P = 0.04). Similarly, the thickness of m. rectus femoris increased more in the placebo group [16.2% (12.8, 24.1)] than in the antioxidant group [10.9% (9.8, 13.5); P = 0.01]. Increases of lean mass in trunk and arms, and muscle thickness of elbow flexors, did not differ significantly between groups. With no group differences, 1RM improved in the range of 15-21% ( P < 0.001). In conclusion, high-dosage vitamin C and E supplementation blunted certain muscular adaptations to strength training in elderly men. [ABSTRACT FROM AUTHOR]

Background Insulin resistance promotes liver disease progression and may be associated with a lower response rate in treated hepatitis C virus ( HCV) infected patients. n-3 polyunsaturated fatty acid ( PUFA) supplementation may reduce insulin resistance. The present study aimed to evaluate the effect of n-3 PUFA supplementation on insulin resistance in these patients. Methods In a randomised, double-blind clinical trial, 154 patients were screened. After applying inclusion criteria, 52 patients [homeostasis model assessment index of insulin resistance ( HOMA- IR ≥2.5)] were randomly divided into two groups: n-3 PUFA ( n = 25/6000 mg day−1 of fish oil) or control ( n = 27/6000 mg day−1 of soybean oil). Both groups were supplemented for 12 weeks and underwent monthly nutritional consultation. Biochemical tests were performed at baseline and after intervention. Statistical analysis was performed using the Wilcoxon Mann-Whitney test for comparisons and the Wilcoxon test for paired data. Statistical package r, version 3.02 (The R Project for Statistical Computing) was used and P < 0.05 (two-tailed) was considered statistically significant. Results Comparisons between groups showed that n-3 PUFA supplementation was more effective than the control for reducing HOMA- IR ( P = 0.015) and serum insulin ( P = 0.016). The n-3 PUFA group not only showed a significant reduction in HOMA- IR 3.8 (3.2-5.0) versus 2.4 (1.8-3.3) ( P = 0.002); serum insulin 17.1 (13.8-20.6) μ IU mL−1 versus 10.9 (8.6-14.6) μ IU mL−1 ( P = 0.001); and glycated haemoglobin 5.4% (5.0-5.7%) versus 5.1% (4.8-5.6%) ( P = 0.011), but also presented an increase in interleukin-1 97.5 (0.0-199.8) pg mL−1 versus 192.4 (102.2-266.8) pg mL−1 ( P = 0.003) and tumour necrosis factor 121.2 (0.0-171.3) pg mL−1 versus 185.7 (98.0-246.9) pg mL−1 ( P = 0.003). Conclusions n-3 PUFA supplementation reduces insulin resistance in genotype 1 HCV infected patients. [ABSTRACT FROM AUTHOR]

Objective Evaluate the immediate and cumulative optical whitening efficacy of a blue covarine toothpaste. Materials and Methods 180 bovine tooth specimens with similar shade (Δ E < 3.5) were staining of different beverage: black tea(BT), green tea (GT), red wine (RW), orange soda (OS), and brazilian açai juice (AJ), and then submitted to tooth brushing with a blue covarine toothpaste (Op) or a control abrasive toothpaste (Ab). The whitening effect was evaluated at baseline (B), after staining (S), after 1 day (1D) and 7 days of cumulative use of toothpastes (7D). The color shade chances were assessment by Vita Easyshade reflectance spectroscope and the data of CIELab color coordinates (L*, a*, and b*), color difference (Δ E) and the whiteness index optimized (WIO), were analyzed by two-way mixed analysis of variance (ANOVA) for repeated measures and Bonferroni-corrected t-tests (α = 0.05). Results The analysis showed statistically significant differences before and after staining by colored beverages ( p < 0.05), but no differences were found due to the action of toothpaste ( p > 0.05), in the CIELab coordinates, Δ E and WIO index. Conclusions The use of toothpastes (Op or Ab) reduced the dental staining caused by different colored beverage, but the whitening effect of blue covarine toothpaste could not be confirmed ( p > 0.05). [ABSTRACT FROM AUTHOR]

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Background An increased plasma lipopolysaccharide ( LPS) concentration may favour metabolic disorders such as insulin resistance. The meal composition influences plasma LPS concentrations. The present study aimed to investigate the effect of the acute consumption of a high-fat meal (49% of energy from fat) containing conventional or high-oleic peanuts on post-prandial LPS concentrations and its relationship with lipaemia and insulinaemia in overweight and obese men. Methods The test meal consisted of a shake containing conventional peanuts ( CVP; n = 21), high-oleic peanuts ( HOP; n = 23) or a control biscuit ( CT; n = 21). Blood samples were collected in the fasting state and 1, 2 and 3 h post-prandially. LPS, insulin, lipids and glucose concentrations were assessed. Results LPS concentrations were lower in CVP [mean (SE) 0.7 (0.5) EU mL−1] and HOP [1.0 (0.9) EU mL−1] groups compared to CT [1.6 (1.2) EU mL−1] at 3 h post-prandially. Triacylglycerol and insulin concentrations increased in all groups. Triacylglycerol started to increase only after 2 h in the CVP and HOP groups. LPS correlated positively with triacylglycerol. Insulin returned to basal concentrations at 3 h only in the CVP and HOP groups. Conclusions The acute consumption of peanuts delayed the increase in serum triacylglycerol and favoured the quicker return of insulin to basal concentrations, especially in the CVP group. Our results suggest that the consumption of conventional or high-oleic peanuts may help to reduce the risk of endotoxaemia and metabolic disorders. [ABSTRACT FROM AUTHOR]

Objectives Patients with asthma commonly present to emergency departments ( ED) with exacerbations. Asthma guidelines recommend close follow-up with a primary care provider ( PCP) after ED discharge; however, this linkage is often delayed or absent. The objective of this study was to assess whether ED-directed educational interventions improve office follow-up with PCPs after ED discharge for acute asthma. Methods Comprehensive literature searches were conducted in seven electronic databases (1946 to 2014). Randomized controlled clinical trials examining the effectiveness of educational interventions to increase office follow-up with a PCP were included. Study quality was determined using the Cochrane risk of bias tool; fidelity of the interventions was assessed using the Treatment Fidelity Assessment Grid. Using study data, risk ratios ( RRs),and the number needed to treat for benefit ( NNTB) with 95% confidence intervals ( CI) were calculated using random-effects models. Results From 427 potentially relevant studies, five ( n = 825) were included. The overall risk of bias was unclear, and the description of intervention fidelity varied across the studies. Educational interventions targeting either patients or PCPs led to a greater likelihood of having primary care follow-up after ED discharge ( RR = 1.6; 95% CI = 1.31 to 1.87; I2 = 0%). The number needed to treat for benefit was six (95% CI = 4 to 11). No significant benefit was observed in reductions of relapses ( RR = 1.3; 95% CI = 0.82 to 1.98; I2 = 23%) and admissions ( RR = 0.51; 95% CI = 0.24 to 1.06; I2 = 0%). Due to the small number of studies for each comparison, publication bias was not formally assessed. Conclusions ED-directed educational interventions targeting either patients or providers increase the chance of having office follow-up visits with PCPs after asthma exacerbations. Their impact on health-related outcomes (e.g., relapse and admissions) remains unclear. [ABSTRACT FROM AUTHOR]

Objectives Accelerated diagnostic protocols ( ADPs), such as the HEART Pathway, are gaining popularity in emergency departments ( EDs) as tools used to risk stratify patients with acute chest pain. However, provider nonadherence may threaten the safety and effectiveness of ADPs. The objective of this study was to determine the frequency and impact of ADP nonadherence. Methods A secondary analysis of participants enrolled in the HEART Pathway RCT was conducted. This trial enrolled 282 adult ED patients with symptoms concerning for acute coronary syndrome without ST-elevation on electrocardiogram. Patients randomized to the HEART Pathway ( N = 141) were included in this analysis. Outcomes included index visit disposition, nonadherence, and major adverse cardiac events ( MACEs) at 30 days. MACE was defined as death, myocardial infarction, or revascularization. Nonadherence was defined as: 1) undertesting-discharging a high-risk patient from the ED without objective testing (stress testing or coronary angiography) or 2) overtesting-admitting or obtaining objective testing on a low-risk patient. Results Nonadherence to the HEART Pathway occurred in 28 of 141 patients (20%, 95% confidence interval [ CI] = 14% to 27%). Overtesting occurred in 19 of 141 patients (13.5%, 95% CI = 8% to 19%) and undertesting in nine of 141 patients (6%, 95% CI = 3% to 12%). None of these 28 patients suffered MACE. The net effect of nonadherence was 10 additional admissions among patients identified as low-risk and appropriate for early discharge (absolute decrease in discharge rate of 7%, 95% CI = 3% to 13%). Conclusions Real-time use of the HEART Pathway resulted in a nonadherence rate of 20%, mostly due to overtesting. None of these patients had MACE within 30 days. Nonadherence decreased the discharge rate, attenuating the HEART Pathway's impact on health care use. [ABSTRACT FROM AUTHOR]