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

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

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

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

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

Background and Aims It has been proposed that more use should be made of Bayes factors in hypothesis testing in addiction research. Bayes factors are the ratios of the likelihood of a specified hypothesis (e.g. an intervention effect within a given range) to another hypothesis (e.g. no effect). They are particularly important for differentiating lack of strong evidence for an effect and evidence for lack of an effect. This paper reviewed randomized trials reported in Addiction between January and June 2013 to assess how far Bayes factors might improve the interpretation of the data. Methods Seventy-five effect sizes and their standard errors were extracted from 12 trials. Seventy-three per cent ( n = 55) of these were non-significant (i.e. P > 0.05). For each non-significant finding a Bayes factor was calculated using a population effect derived from previous research. In sensitivity analyses, a further two Bayes factors were calculated assuming clinically meaningful and plausible ranges around this population effect. Results Twenty per cent ( n = 11) of the non-significant Bayes factors were < ⅓ and 3.6% ( n = 2) were > 3. The other 76.4% ( n = 42) of Bayes factors were between ⅓ and 3. Of these, 26 were in the direction of there being an effect (Bayes factor > 1 and < 3); 12 tended to favour the hypothesis of no effect (Bayes factor < 1 and > ⅓); and for four there was no evidence either way (Bayes factor = 1). In sensitivity analyses, 13.3% of Bayes Factors were < ⅓ ( n = 20), 62.7% ( n = 94) were between ⅓ and 3 and 24.0% ( n = 36) were > 3, showing good concordance with the main results. Conclusions Use of Bayes factors when analysing data from randomized trials of interventions in addiction research can provide important information that would lead to more precise conclusions than are obtained typically using currently prevailing methods. [ABSTRACT FROM AUTHOR]

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

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

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

Background: Delirium, which is frequently encountered in intensive care patients, can be prevented with multicomponent nursing interventions, and thus the negative consequences can be reduced. Aim: To examine the effect of using eye masks and earplugs in preventing delirium in intensive care units (ICUs). Study Design: A randomized, controlled, single‐blind intervention study. This study was conducted in the medical and surgical ICUs of a tertiary hospital, and nurses were given pre‐study training on delirium risks, diagnosis, prevention, and management. Data were collected using the patient information form, the Nursing Delirium Screening Scale, the Richard–Campbell Sleep Scale, and the daily follow‐up form. Various environmental modifications were made in the ICUs for all patients, and evidence‐based nonpharmacological nursing interventions were applied to the patients in both groups during the day and night shifts for 3 days. In addition, the patients in the intervention group were provided with eye masks and earplugs for three nights. Results: The study included a total of 60 patients (30 in the intervention group and 30 in the control group). There was a statistically significant difference in the development of delirium between the intervention and control groups (night of the 2nd day, p =.019; day of the 3rd day p <.001; night of the 3rd day p ≤.001). The average total sleep quality score of the intervention group was found to be significantly higher than the control group (p ≤.001 for three nights). Staying in the internal medicine ICU affected (odds ratio [OR], 11.84; 95% confidence interval [CI], 3.00–46.66; p =.017) more on the development of delirium than in coronary ICU, being in the age group of 65 and over, having a hearing impairment, coming to ICU from the operating room, and education level had an effect. Conclusions: The earplugs and eye masks used by the intensive care patients overnight were found to be effective in increasing sleep quality and preventing delirium. Relevance to Clinical Practice: The use of eye masks and earplugs is recommended for ICUs in preventing delirium. [ABSTRACT FROM AUTHOR]

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

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

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

Enhanced recovery after surgery protocol is a multidisciplinary and multimodal approach designed to improve perioperative outcomes for patients. This meta‐analysis aimed to identify and elaborate on the efficacy of this protocol in women undergoing gynecologic surgery. Four databases were searched for randomized controlled trials from inception to December 2021. A total of 14 studies met the inclusion criteria and were analyzed. There was a significant reduction in the length of stay, the time to first flatus and first defecation, complications, and readmission rates in patients undergoing enhanced recovery after surgery when compared to routine care. The rate of discharge on the first postoperative day significantly increased in patients from the enhanced recovery group. There was no significant difference in the surgery time and blood loss. In conclusion, the enhanced recovery after surgery protocol might have a positive effect on patients undergoing gynecologic surgery. However, there is still heterogeneity between the included studies, and we need more research to draw reliable conclusions that enhanced recovery after surgery is favorable. [ABSTRACT FROM AUTHOR]

Background: Haemodialysis plastic cannulae have been limited to incident arterio‐venous fistulae cannulation or in those who require a more flexible in situ access device. The feasibility of plastic cannulae in prevalent patients on haemodialysis has not been reported. Objective: To determine the feasibility of plastic cannulae in prevalent haemodialysis patients. Design: Prospective feasibility crossover randomised control trial. Participants: Adults diagnosed with chronic kidney disease G5 requiring haemodialysis three or more times per week via a native arteriovenous fistula previously cannulated for at least 6 weeks. Measurements: Cannulation success rate, cannulation manipulation type, arterial and venous needle pressure. Patient needle‐related anxiety as measured by the 4‐item Patient Health Questionnaire and Meditation in Dialysis Questionnaire and nurse satisfaction. Results: Eight patients completed 12 weeks plastic canulae and metal needles. Plastic cannulae were less likely to be successful in cannulation compared to metal needles (odds ratio = 0.15; 95% confidence interval [CI]: 0.05–0.48; p = 0.001). There was no effect of type of needle on the change in arterial needle pressure or change in venous needle pressure and no effect of plastic needle on repositioning (relative risk [RR] = 1.09; 95% CI: 0.385, 3.089; p =.871) or gauze pillow application (RR = 0.936; 95% CI: 0.467, 1.874; p =.851) than metal needles, relative to no manipulation. There were low rates of psychological distress or needle‐related anxiety towards plastic or metal needles. Conclusions: Plastic cannulae are feasible in prevalent haemodialysis patients, however, metal needles are still preferred in a haemodialysis center that has historically used metal needles. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the clinical non‐inferiority of a 3‐day protocol of systemic antibiotics adjunctive to subgingival instrumentation (SI) compared with a 7‐day‐protocol in patients with Stage III/IV Grade C periodontitis. Materials and Methods: Fifty systemically healthy patients (32.7 ± 4.3 years) with aggressive periodontitis (AgP; Stage III/IV Grade C periodontitis) were treated by SI and adjunctive amoxicillin and metronidazole and were randomly assigned to Group A: (n = 25) 500 mg antibiotics (AB) 3 times a day for 3 days, followed by placebo 3 times a day for 4 days, or Group B: (n = 25) 500 mg AB 3 times a day for 7 days. Clinical, microbial, and immunological parameters were assessed at baseline, 3 months, and 6 months, and patient‐related outcomes were assessed after 2 weeks. The primary outcome variable was the number of residual sites with pocket depth (PD) ≥6 mm at 6 months. Results: For the primary outcome variable (the number of residual sites with PD ≥6 mm at 6 months), the null hypothesis was rejected and non‐inferiority of the 3‐day AB protocol compared with the 7‐day AB protocol was demonstrated (the upper limits of the 95% confidence interval for intention to treat analysis: [−2.572; 1.050] and per protocol analysis: [−2.523; 1.318] were lower than the assumed margin of Δ = 3.1). Comparable clinical improvements were obtained for all parameters with both antibiotic protocols (p >.05). All investigated periodontopathogens and pro‐inflammatory host‐derived markers were statistically significantly reduced without differences between the treatments (p >.05). Conclusions: These findings indicate that in patients with AgP (Stage III/IV Grade C periodontitis), a 3‐day systemic administration of amoxicillin and metronidazole adjunctive to SI may lead to non‐inferior clinical outcomes after 6‐months with fewer adverse events compared with a 7‐day‐protocol. [ABSTRACT FROM AUTHOR]

Background: In‐hospital cardiac arrest is a medical emergency that occurs on a regular basis. As patients most at risk for an in‐hospital cardiac arrest are usually positioned on a dynamic mattress, it is important to measure the effect of mattress compressibility on chest compression quality during cardiopulmonary resuscitation (CPR). High‐quality CPR is essential for patient survival and good neurological outcome. Aims and objectives: To examine the effect of an inflated dynamic overlay mattress on chest compression quality during CPR and to explore the predictive effect of health care providers' anthropometric factors, hand positioning and mattress type on chest compression frequency and depth. Design: Manikin‐based single‐blinded randomised controlled trial. Methods: Nursing students (N = 70) were randomised to a control (viscoelastic foam mattress) or intervention group (inflated dynamic overlay mattress on top of a viscoelastic foam mattress) and had to perform chest compressions over a 2‐minute period. Compression rate, depth and hand positioning were registered. The 2015 European Resuscitation Council (ERC) guidelines were used as a reference. Results: The mean difference in chest compression depth between control and intervention groups was 2.86 mm (P =.043). Both groups met the guidelines for adequate chest compression quality, as recommended by the ERC. A predictive effect of health care providers' body height and weight, mattress type and hand positioning on compression depth could be demonstrated (P =.004). Conclusions: CPR in bedridden patients on a dynamic overlay mattress has a negative effect on the quality of chest compressions. Mean chest compression depth decreases significantly. However, clinical significance of the results may be debatable. Mattress type, body weight and hand positioning appear to be significant predictors for adequate chest compression depth. Relevance to clinical practice: A firm surface under the patient is needed during CPR. Special attention must be paid to correct hand positioning during CPR. [ABSTRACT FROM AUTHOR]

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

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

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

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

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

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]

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

Objectives: 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: Previous studies have shown that feeding a high‐energy formula (HF) to infants after cardiac surgery increases energy intake, with fewer side effects on cardiopulmonary function. However, impacts on weight gain and gastrointestinal function remain unclear. Aims and objectives: To determine the impact of HF compared with standard formula on weight gain and gastrointestinal tolerance in postoperative infants with congenital heart disease. Design This was a randomized controlled trial. Methods: The setting of the study was at a 20‐bed cardiac intensive care unit at a tertiary children's hospital in China. Study population included infants <1 year of age who underwent cardiac surgery and were allocated to the intervention group (n = 32) or control group (n = 32). The intervention group received HF (100 kcal/100 mL), and the control group received standard formula (67 kcal/100 mL) for 7 days during the stabilized postoperative period at the cardiac intensive care unit. Primary outcomes were weight gain and gastrointestinal intolerance. Secondary outcomes were energy intake and standard intensive care characteristics. Results: Infants who received HF (n = 30) showed less weight loss than those who received standard formula (n = 29); −16 g [95% confidence interval (CI): −74 to 42] versus −181 g (95% CI: −264 to −99), P = 0·001. The evaluation of gastrointestinal intolerance showed that the intervention group had several side effects, such as abdominal distension (n = 1), gastric retention (n = 2) and diarrhoea (n = 1), while the control group had no problems. Enteral energy intake in the intervention group was higher than the control group from day three. Conclusion: Infants after cardiac surgery fed with HF gained more weight but had increased feeding intolerance. However, the feeding intolerance symptoms could be relieved by medication and did not affect feeding advancement. Relevance to clinical practice: Paediatric intensive care clinicians should consider gradually increasing the energy density of the formula during feeding and assess feeding intolerance signs in some children with malnutrition after cardiac surgery. [ABSTRACT FROM AUTHOR]

Background: To date, the immediate effects of a semi‐occluded vocal tract (SOVT) configuration have been thoroughly demonstrated. However, it is not yet sufficiently confirmed whether a therapy programme (i.e. longer than one session) using SOVT exercises leads to an enhanced phonation and improved vocal quality. Aims: The aim of this study was to investigate the effect of three SOVT therapy programmes: lip trill, water‐resistance therapy (WRT) and straw phonation, on the vocal quality, vocal capacities, psychosocial impact and vocal tract discomfort of patients with dysphonia. Methods & Procedures: A blocked‐randomized sham‐controlled trial was used. Thirty‐five patients with dysphonia (mean age = 21 years; 33 women, two men) were assigned to either a lip trill group, a WRT group, a straw phonation group or a control group using blocked randomization. The lip trill, WRT and straw phonation groups practised their respective SOVT exercise across 3 weeks, whereas the control group received a sham treatment across the same time span. A multidimensional voice assessment consisting of both objective (multiparametric indices: Dysphonia Severity Index (DSI), Acoustic Voice Quality Index (AVQI)) and subjective (subject's self‐report, auditory–perceptual evaluation) vocal outcomes was performed by a blinded assessor pre‐ and post‐therapy. Outcomes & Results: Lip trill and straw phonation therapy led to a significant improvement in DSI. Auditory–perceptual grade and roughness significantly decreased after straw phonation. Lip trill and WRT both led to a significant decrease in Voice Handicap Index. Subjects reported a better self‐perceived vocal quality and a more comfortable voice production after WRT. No changes were found after the sham treatment in the control group. Conclusions & Implications: Results suggest that SOVT therapy programmes including lip trill or straw phonation can improve the objective vocal quality in patients with dysphonia. Auditory–perceptual improvements were found after straw phonation therapy, whereas psychosocial improvements were found after lip trill and WRT. Patients seem to experience more comfort and a better self‐perceived vocal quality after WRT. This study supports the use of the three SOVT therapy programmes in clinical practice. They all had a positive impact on one or more outcomes of the multidimensional voice assessment. Strikingly, vocal quality outcomes were not in line with the subject's opinion. Larger‐scale investigation is needed to support these preliminary findings. [ABSTRACT FROM AUTHOR]

Objective Guided self-help treatments based on cognitive-behavior therapy (CBT-GSH) are efficacious for binge eating. With limited availability of CBT-GSH in the community, mobile technology offers a means to increase use of these interventions. The purpose of this study was to test the initial efficacy of Noom Monitor, a smartphone application designed to facilitate CBT-GSH (CBT-GSH + Noom), on study retention, adherence, and eating disorder symptoms compared to traditional CBT-GSH. Method Sixty-six men and women with DSM- 5 binge-eating disorder (BED) or bulimia nervosa (BN) were randomized to receive eight sessions of CBT-GSH + Noom ( n = 33) or CBT-GSH ( n = 33) over 12 weeks. Primary symptom outcomes were eating disorder examination objective bulimic episodes (OBEs), subjective bulimic episodes (SBEs), and compensatory behaviors. Assessments were collected at 0, 4, 8, 12, 24, and 36 weeks. Behavioral outcomes were modeled using zero-inflated negative-binomial latent growth curve models with intent-to-treat. Results There was a significant effect of treatment on change in OBEs (β = −0.84, 95% CI = −1.49, −0.19) favoring CBT-GSH + Noom. Remission rates were not statistically different between treatments for OBEs (βlogit = −0.73, 95% CI = −1.86, 3.27; CBT-GSH-Noom = 17/27, 63.0% vs. CBT-GSH 11/27, 40.7%, NNT = 4.5), but CBT-GSH-Noom participants reported greater meal and snack adherence and regular meal adherence mediated treatment effects on OBEs. The treatments did not differ at the 6-month follow-up. Discussion Smartphone applications for the treatment binge eating appear to have advantages for adherence, a critical component of treatment dissemination. [ABSTRACT FROM AUTHOR]

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

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

Background: Children with intellectual and developmental disabilities (IDD) experience heightened attention difficulties which have been linked to poorer cognitive, academic and social outcomes. Although, increasing research has focused on the potential of computerised cognitive training in reducing attention problems, limited studies have assessed whether this intervention could be utilised for those with IDD. This study aimed to assess the efficacy of a computerised attention training programme in children with IDD. Methods: In a double-blind randomised controlled trial, children (n = 76; IQ < 75) aged 4–11 years were assigned to an adaptive attention training condition or a nonadaptive control condition. Both conditions were completed at home over a 5-week period and consisted of 25 sessions, each of 20-min duration. Outcome measures (baseline, posttraining and 3-month follow-up) assessed core attention skills (selective attention, sustained attention and attentional control) and inattentive/hyperactive behaviour. Results: Children in the attention training condition showed greater improvement in selective attention performance compared to children in the control condition (SMD = 0.24, 95% CI 0.02, 0.45). These improvements were maintained 3 months after training had ceased (SMD = 0.26, 95% CI 0.04, 0.48). The attention training programme was not effective in promoting improvements in sustained attention, attentional control or inattentive/ hyperactive behaviours. Conclusions: The findings suggest that attention training may enhance some aspects of attention (selective attention) in children with IDD, but the small to medium effect sizes indicate that further refinement of the training programme is needed to promote larger, more global improvements. [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 To evaluate the effect of 3 or 7 days systemic administration of amoxicillin ( AMX) and metronidazole ( MET) or placebo as adjunct to non-surgical periodontal treatment in severe chronic periodontitis patients. Methods One hundred and two patients with severe chronic periodontitis [e.g. ≥1 site with probing pocket depth ( PD) ≥ 6 mm per quadrant] were randomly divided into three equally sized groups and treated with either scaling and root planing within 24 h ( SRP) + placebo (Group A) or SRP + AMX + MET (both 500 mg × 3 times daily) for 3 days (Group B) or SRP + AMX + MET (both 500 mg × 3 times daily) for 7 days (Group C). PD, clinical attachment level ( CAL), bleeding on probing ( BOP), full-mouth plaque scores ( FMPS) and gingival bleeding index ( GBI) were assessed prior to treatment (baseline), and at 3 and 6 months post-treatment. The primary outcome variable was the difference (Δ) in the number of sites with PD ≥ 6 mm. Results Ninety-one patients completed the study. At both 3 and 6 months, all three treatment protocols resulted in statistically significant improvements compared to baseline for all evaluated clinical parameters ( p < 0.001). At 6 months, a statistically significantly greater reduction in the mean number of sites with PD ≥ 6 mm was observed in group B (28.62 ± 15.32 sites) and group C (30.45 ± 15.04 sites) compared to the placebo group (17.10 ± 14.68 sites). Furthermore, both the 3- and the 7-day antibiotic regimen resulted in statistically significantly higher clinical improvements compared to the placebo group ( p < 0.05). Conclusion The present findings indicate that in patients with severe chronic periodontitis, non-surgical periodontal therapy in conjunction with a 3 or 7 days systemic administration of AMX + MET may lead to significantly greater clinical improvements compared to non-surgical therapy alone. [ABSTRACT FROM AUTHOR]

Aims To determine the effectiveness and safety of varenicline in treating tobacco dependence in patients with severe mental illness. Design A systematic reviewand meta-analysis of randomised controlled trials that compared varenicline with a placebo or an alternative intervention for smoking cessation or reduction. Setting Both in- and out-patient settings in any country. Participants Adult patients aged 18 years and over with any type of severe mental illness. The systematic review included eight studies comprising 398 participants. Measures Primary outcome measures were (1) smoking cessation, (2) smoking reduction measured by changes in the number of cigarettes smoked per day and (3) number of psychiatric adverse events, which were collected at the end of treatment. Findings The random-effect pooled estimates from the five studies that reported smoking-related outcomes found that varenicline is statistically superior to placebo in smoking cessation [risk ratios 4.33; 95% confidence interval (CI)=1.96-9.56], and smoking reduction was higher in varenicline groups (mean reduced daily cigarettes was 6.39; 95% CI=2.22-10.56). There is no significant difference regarding neuropsychiatric and other adverse events. Conclusions Varenicline appears to be significantly more effective than placebo in assisting with smoking cessation and reduction in people with severe mental illness. There appears to be no clear evidence that varenicline was associated with an increased risk of neuropsychiatric or other adverse events compared with placebo. [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 and Aims Previous studies have reported that people who use a smoking cessation medication while smoking and reduce cigarette consumption spontaneously are three times more likely to stop smoking after a quit date. The aim was to replicate this and assess whether it arises because of willed effortful reduction rather than unwilled reduced drive to smoke caused by medication. Design Secondary analysis of a trial where participants were randomised to smoke as normal or reduce by 75% over 2 weeks prior to quit date, using nicotine replacement therapy (NRT) in both arms. Setting Thirty-one UK primary care practices. Participants A total of 517 adult smokers seeking quitting support in the carbon monoxide (CO) analyses and 421 in the cigarettes/day analyses. Measurements Russell Standard abstinence was recorded 4 weeks after quit date. The randomized groups were combined and the association between reduction and abstinence examined. The second analysis assessed whether this association differed by whether smokers were, or were not, instructed to reduce. Findings In all participants, there was no evidence that reducing cigarettes/day or CO by at least half compared with not reducing predicted abstinence at 4 weeks [risk ratio (RR) = 0.88; 95% confidence interval (CI) = 0.68-1.14 and RR = 1.20; 95% CI = 1.00-1.44, respectively]. However, in smokers instructed to reduce, CO reduction was associated with 4-week abstinence (RR = 1.52; 95% CI = 1.16-2.00), but not among people advised not to reduce (RR = 0.91; 95% CI = 0.67-1.24). Conclusions Smoking reduction prior to a target quit date while on a smoking cessation medication may only predict subsequent abstinence when smokers are consciously attempting to reduce. [ABSTRACT FROM AUTHOR]

Background Extended-release guanfacine hydrochloride ( GXR), a selective α2A-adrenergic agonist, is a nonstimulant medication for attention-deficit/hyperactivity disorder ( ADHD). This phase 3, double-blind, placebo-controlled, randomised-withdrawal study evaluated the long-term maintenance of GXR efficacy in children/adolescents with ADHD. Methods Children/adolescents (6-17 years) with ADHD received open-label GXR (1-7 mg/day). After 13 weeks, responders were randomised to GXR or placebo in the 26-week, double-blind, randomised-withdrawal phase ( RWP). The primary endpoint was the percentage of treatment failure (≥50% increase in ADHD Rating Scale version IV total score and ≥2-point increase in Clinical Global Impression-Severity compared with RWP baseline, at two consecutive visits). The key secondary endpoint was time to treatment failure ( TTF). Trial registration ClinicalTrials.gov identifier NCT01081145; Eudra CT 2009-018161-12. Results A total of 528 participants enrolled; 316 (59.8%) entered the RWP. Treatment failure occurred in 49.3% of the GXR and 64.9% of the placebo group ( p = 0.006). TTF was significantly longer in GXR versus placebo ( p = 0.003). GXR was well tolerated. Conclusions Guanfacine hydrochloride demonstrated long-term maintenance of efficacy compared with placebo in children/adolescents with ADHD. Implications of the placebo substitution design and findings with different ADHD medications are discussed. [ABSTRACT FROM AUTHOR]

Objective The objective of this present study is to compare pain associated with the double-dorsal versus a single-volar subcutaneous injection in the provision of digital anaesthesia for finger injuries presenting to the ED. Methods A randomised controlled trial from November 2012 to January 2014 at a single adult tertiary-referral hospital. ED patients with finger injuries requiring digital anaesthesia was randomised to either the double-dorsal or a single-volar subcutaneous injection technique. The primary outcome was patient reported injection pain measured on a 100 mm visual analogue scale with the assessor blinded to the injection technique. The secondary outcome was success of anaesthesia defined as ability to perform the assessment and treatment without further anaesthetic supplementation after 5 min. Results Eighty-six patients were enrolled. Median (IQR) age was 34 (24-47) years and 79% were men. The majority (66.3%) had distal phalanx injuries. Forty patients were randomised to the double-dorsal and 46 to a single-volar subcutaneous injection technique. The mean (standard deviation) pain score of the double-dorsal injection was 39.1 (24.2) and a single-volar injection was 37.3 (24.5) with a difference of 1.8 (95% CI -8.8 to 12.3). Digital anaesthesia was successful in 64.9% of the double-dorsal and 71.7% of the single-volar subcutaneous injections, a difference of 6.8% (95% CI -12.7 to 26.3). Conclusion In ED patients with finger injuries requiring digital anaesthesia, both the double-dorsal or single-volar subcutaneous injection techniques have similar pain of injection and success rates of anaesthesia. Single-volar injection appears suitable alternative to the commonly performed double-dorsal injection in the ED. [ABSTRACT FROM AUTHOR]

Objective The objective of the study is to evaluate the effect of a brief body and movement oriented intervention on aggression regulation and eating disorder pathology for individuals with eating disorders. Method In a first randomized controlled trial, 40 women were allocated to either the aggression regulation intervention plus supportive contact or a control condition of supportive contact only. The intervention was delivered by a psychomotor therapist. Participants completed questionnaires on anger coping and eating disorder pathology. Independent samples t-tests were performed on the difference between pre-treatment and post-treatment scores. Results Twenty-nine participants completed questionnaires at pre-intervention and post-intervention. The intervention resulted in a significantly greater improvement of anger coping, as well as of eating disorder pathology. Discussion Results indicate that body and movement-oriented aggression regulation may be a viable add-on for treating eating disorders. It tackles a difficult to treat emotion which may have a role in blocking the entire process of treating eating disorders. Copyright © 2015 John Wiley & Sons, Ltd and Eating Disorders Association. [ABSTRACT FROM AUTHOR]

Aim: The purpose of this study was to replicate and extend a pilot evaluation of the effectiveness of school‐based humanistic counselling for psychological distress in young people. Method: Data were available on 32 young people who were randomised to either school‐based humanistic counselling or waiting list conditions for one school term. The primary outcome measure was of psychological distress using the Young Person's CORE (YP‐CORE), at six and 12 weeks post‐assessment. Secondary measures at these time‐points were of psychological difficulties, self‐esteem, levels of depression, and attainment of personal goals; with longitudinal evaluation of outcomes at six months post‐assessment. Results: On the primary outcome measure, participants who received counselling were significantly less distressed at six weeks than those in the waiting list group but not at 12 weeks, with effect sizes (Cohen's d) of 0.59 and 0.39 respectively. Reductions in psychological distress were maintained at follow‐up. Discussion: Although the present findings, in isolation, are equivocal, they contribute to a body of evidence that supports the effectiveness of school‐based humanistic counselling. However, the principal lesson learnt from this study was the need for rigorous training of researchers, counsellors and pastoral care teachers to ensure adherence to protocols. [ABSTRACT FROM AUTHOR]

Background and Aims A broadly mandated reduction of the nicotine content (RNC) of cigarettes has been proposed in the United States to reduce the addictiveness of cigarettes, to prevent new smokers from becoming addicted and to facilitate quitting in established smokers. The primary aim of this study was to determine whether following 7 months of smoking very low nicotine content cigarettes (VLNC), and then returning to their own cigarettes, smokers would demonstrate persistently reduced nicotine intake compared with baseline or quit smoking. Methods In a community-based clinic 135 smokers not interested in quitting were randomized to one of two groups. A research group smoked their usual brand of cigarettes, followed by five types of research cigarettes with progressively lower nicotine content, each for 1 month, followed by 6 months at the lowest nicotine level (0.5 mg/cigarette) (53 subjects) and then 12 months with no intervention (30 subjects completed). A control group smoked their usual brand for the same period of time (50 subjects at 6 months, 38 completed). Smoking behavior, biomarkers of nicotine intake and smoke toxicant exposure were measured. Results After 7 months smoking VLNC, nicotine intake remained below baseline (plasma cotinine 149 versus 250 ng/ml, P<0.005) with no significant change in cigarettes per day or expired carbon monoxide (CO). During the 12-month follow-up, cotinine levels in RNC smokers rose to baseline levels and to those of control smokers. Quit rates among RNC smokers were very low [7.5 versus 2% in controls, not significant). Conclusions In smokers not interested in quitting, reducing the nicotine content in cigarettes over 12 months does not appear to result in extinction of nicotine dependence, assessed by persistently reduced nicotine intake or quitting smoking over the subsequent 12 months. [ABSTRACT FROM AUTHOR]

Aims To examine the effectiveness of a personality-targeted intervention program (Adventure trial) delivered by trained teachers to high-risk (HR) high-school students on reducing marijuana use and frequency of use. Design A cluster-randomized controlled trial. Setting Secondary schools in London, UK. Participants Twenty-one secondary schools were randomized to intervention ( n = 12) or control ( n = 9) conditions, encompassing a total of 1038 HR students in the ninth grade [mean (standard deviation) age = 13.7 (0.33) years]. Interventions Brief personality-targeted interventions to students with one of four HR profiles: anxiety sensitivity, hopelessness, impulsivity and sensation-seeking. Measurements Primary outcome: marijuana use. Secondary outcome: frequency of use. Assessed using the Reckless Behaviour Questionnaire at intervals of 6 months for 2 years. Personality risk was measured with the Substance Use Risk Profile Scale. Findings Logistic regression analysis revealed significant intervention effects on cannabis use rates at the 6-month follow-up in the intent-to-treat sample [odds ratio (OR) = 0.67, P = 0.05, 95% confidence interval (CI) = 0.45-1.0] and significant reductions in frequency of use at 12- and 18-month follow-up (β = -0.14, P ≤ 0.05, 95% CI = -0.6 to -0.01; β = -0.12, P ≤ 0.05, 95% CI = -0.54 to 0.0), but this was not supported in two-part latent growth models. Subgroup analyses (both logistic and two-part models) reveal that the sensation-seeking intervention delayed the onset of cannabis use among sensation seekers (OR = 0.25, β = -0.833, standard error = 0.342, P = 0.015). Conclusions Personality-targeted interventions can be delivered effectively by trained school staff to delay marijuana use onset among a subset of high-risk teenagers: sensation-seekers. [ABSTRACT FROM AUTHOR]

Objectives Successful cricothyrotomy is predicated on accurate identification of the cricothyroid membrane ( CTM) by palpation of superficial anatomy. However, recent research has indicated that accuracy of the identification of the CTM can be as low as 30%, even in the hands of skilled providers. To date, there are very little data to suggest how to best identify this critical landmark. The objective was to compare three different methods of identifying the CTM. Methods A convenience sample of patients and physician volunteers who met inclusion criteria was consented. The patients were assessed by physician volunteers who were randomized to one of three methods for identifying the CTM (general palpation of landmarks vs. an approximation based on four finger widths vs. an estimation based on overlying skin creases of the neck). Volunteers would then mark the skin with an invisible but florescent pen. A single expert evaluator used ultrasound to identify the superior and inferior borders of the CTM. The variably colored florescent marks were then visualized with ultraviolet light and the accuracy of the various methods was recorded as the primary outcome. Additionally, the time it took to perform each technique was measured. Descriptive statistics and report 95% confidence intervals ( CIs) are reported. Results Fifty adult patients were enrolled, 52% were female, and mean body mass index was 28 kg/m2 (95% CI = 26 to 29 kg/m2). The general palpation method was successful 62% of the time (95% CI = 48% to 76%) and took an average of 14 seconds to perform (range = 5 to 45 seconds). In contrast, the four-finger technique was successful 46% of the time (95% CI = 32% to 60%) and took an average of 12 seconds to perform (range = 6 to 40 seconds). Finally, the neck crease method was successful 50% of the time (95% CI = 36% to 64%) and took an average of 11 seconds to perform (range = 5 to 15 seconds). Conclusions All three methods performed poorly overall. All three techniques might potentially be even less accurate in instances where the superficial anatomy is not palpable due to body habitus. These findings should alert clinicians to the significant risk of a misplaced cricothyrotomy and highlight the critical need for future research. [ABSTRACT FROM AUTHOR]

Background and Purpose Low-level laser therapy (LLLT) is proposed as a treatment for tendinopathies. This is the first systematic review focusing solely on LLLT treatment effects in shoulder tendinopathy. Methods A systematic review with meta-analysis and primary outcome measures pain relief on 100-mm visual analogue scale (VAS) and relative risk for global improvement. Two independent assessors rated the included studies according to the PEDro scale. Intervention quality assessments were performed of LLLT dosage and treatment procedures according to World Association for Laser Therapy guidelines. The included trials were sub-grouped by intervention quality and use of other physiotherapy interventions. Results Seventeen randomized controlled trials (RCTs) met the inclusion criteria, and 13 RCTs were of high and 4 RCTs of moderate methodological quality. Significant and clinically important pain relief was found with weighted mean differences (WMD) over placebo, for LLLT as monotherapy at 20.41 mm (95% CI: 12.38 to 28.44) and as adjunct to exercise therapy at 16.00 mm (95% CI: 11.88 to 20.12). The WMD when LLLT was used in a multimodal physiotherapy treatment regime reached statistical significance over placebo at 12.80 (95% CI: 1.67-23.94) mm pain reduction on VAS. Relative risks for global improvement were statistically significant at 1.96 (95% CI: 1.25-3.08) and 1.51 (95% CI: 1.12-2.03), for laser as monotherapy or adjunctive in a physiotherapy regime, respectively. Secondary outcome measures of shoulder function were only significantly in favour of LLLT when used as monotherapy. Trials performed with inadequate laser doses were ineffective across all outcome measures. Conclusion This review shows that optimal LLLT can offer clinically relevant pain relief and initiate a more rapid course of improvement, both alone and in combination with physiotherapy interventions. Our findings challenge the conclusions in previous multimodal shoulder reviews of physiotherapy and their lack of intervention quality assessments. Copyright © 2014 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Aims To determine the efficacy of acamprosate and naltrexone in the treatment of those who are alcohol-dependent in reducing lapse/relapse to alcohol consumption and treatment discontinuation, and to examine whether a proportion of the variance in study outcome can be explained by the country in which the trials have taken place. Method A systematic review and meta-analysis of randomized controlled trials published before September 2013 was conducted. The primary outcome measures were the efficacy of acamprosate or naltrexone in reducing lapse/relapse compared to placebo in the treatment of alcohol dependence and treatment discontinuation. Twenty-two randomized controlled trials (RCTs) of the efficacy of acamprosate met inclusion criteria for the meta-analysis, with a total of 2649 participants in the acamprosate group and 2587 in the placebo group. Twenty-seven RCTs of the efficacy of naltrexone met inclusion criteria for the meta-analysis, with a total of 2253 participants in the naltrexone group and 1946 in the placebo group. A random-effects model using a Mantel-Haenszel method was applied to conduct the meta-analysis. Variance in study outcomes was explored using subgroup analysis of Europe versus the rest of the world (ROW). Results The risk of returning to any drinking at 6 months was significantly lower for acamprosate [risk ratio (RR) = 0.83, 95% confidence interval (CI) = 0.78-0.89]. There was little difference in the risk of participants discontinuing treatment for any reason (RR = 0.91, 95% CI = 0.83-1.00) or due to adverse events (RR = 1.30, 95% CI = 0.96-1.75) for the acamprosate compared to placebo groups. The risk of individuals returning to any drinking at approximately 3 months was reduced significantly for the naltrexone group (RR = 0.92, 95% CI = 0.86-1.00), as was the risk of individuals relapsing to heavy drinking at 3 months (RR = 0.85, 95% CI = 0.78-0.93). There was no significant difference between naltrexone and placebo for the risk of individuals discontinuing treatment for any reason (RR = 0.94, 95% CI = 0.84-1.05). There was a significantly greater risk of participants in the naltrexone group discontinuing treatment due to adverse events compared to placebo (RR = 1.72, 95% CI = 1.10-2.70). Subgroup analysis by country (Europe versus ROW) revealed no difference in risk between acamprosate and placebo for the outcomes returning to any drinking at 6 months and discontinuing treatment due to adverse events. For the outcome discontinuation of treatment for any reason, there was a significant difference in RR between Europe and the ROW (χ2 = 11.65, P <0.001) for acamprosate. Acamprosate was associated with a reduction in risk of discontinuing treatment for Europe (RR = 0.86, 95% CI = 0.79-0.95), but an increase in risk of discontinuing treatment for ROW (RR = 1.23, 95% CI = 1.03-1.48). Conclusions Both acamprosate and naltrexone appear to reduce the risk of individuals returning to drinking alcohol in those who are alcohol-dependent. The country in which a randomized control trial (RCT) for the efficacy of acamprosate and naltrexone is completed does not appear to explain the variance in trial outcomes for returning to drinking alcohol or discontinuing drinking due to adverse effects. However, the country in which the RCT of acamprosate are completed may be important for explaining the variance between studies for the outcome 'discontinuing treatment for any reason'. [ABSTRACT FROM AUTHOR]

Objectives Treatment failure is a common phenomenon, but little is known about the reasons. Therapeutic alliance, therapist adherence, and therapist competence are considered important aspects of treatment success and formed the focus of the current investigation. Design Three randomized controlled trials for the treatment of depression, social phobia, and hypochondriasis were the basis of the current study. Methods The role of therapeutic alliance, as well as therapist adherence and competence, were investigated in 61 patients, which were classified either as treatment failure or as treatment success. Process variables were evaluated by independent raters on the basis of videotapes of the first three treatment sessions. Results Therapists' adherence and therapeutic alliance differed significantly between successful treatments and those classified as failures, whereas therapists' competence did not. In cross-sectional analysis, we found a moderating effect of adherence with alliance on treatment outcome, indicating that the better the therapeutic alliance, the stronger the effect of adherence on treatment outcome. Moreover, higher therapists' competence was found to affect treatment outcome positively, only mediated by therapeutic alliance. Higher therapists' adherence affected treatment outcome positively, only mediated by the competence-alliance relationship. In additional longitudinal analyses, we found evidence that the therapeutic alliance within one session influences therapists' adherence and competence in the subsequent session, but not the other way around. Conclusions Therapeutic alliance proved to be an important variable for the prediction of treatment failure. Furthermore, in our longitudinal analyses, we found evidence that the therapeutic alliance is a precondition for the adherent and competent implementation of therapeutic techniques, which questions the results of our cross-sectional analysis and of previous research. Practitioner points Clinical implications Treatment failure is associated with a lower therapeutic alliance in cognitive-behavioural treatment., Therapeutic alliance seems to be an important precondition for the adherent and competent implementation of therapeutic techniques., Therapeutic alliance should be monitored during psychotherapeutic treatment., Cautions or limitations Results are limited to cognitive-behavioural therapy and may not be representative for other treatment approaches., Process analyses are based on highly standardized randomized controlled trials and may not be generalizable to routine care. [ABSTRACT FROM AUTHOR]

Objectives Acupuncture is commonly used as a complimentary treatment for pain management. However, there has been no systematic review summarizing the current evidence concerning the effectiveness of acupuncture for acute postoperative pain after back surgery. This systematic review aimed at evaluating the effectiveness of acupuncture treatment for acute postoperative pain (≤1 week) after back surgery. Methods We searched 15 electronic databases without language restrictions. Two reviewers independently assessed studies for eligibility and extracted data, outcomes, and risk of bias. Random effect meta-analyses and subgroup analyses were performed. Results Five trials, including 3 of high quality, met our inclusion criteria. The meta-analysis showed positive results for acupuncture treatment of pain after surgery in terms of the visual analogue scale ( VAS) for pain intensity 24 hours after surgery, when compared to sham acupuncture (standard mean difference −0.67 (−1.04 to −0.31), P = 0.0003), whereas the other meta-analysis did not show a positive effect of acupuncture on 24-hour opiate demands when compared to sham acupuncture (standard mean difference −0.23 (−0.58 to 0.13), P = 0.21). Conclusion Our systematic review finds encouraging but limited evidence for the effectiveness of acupuncture treatment for acute postoperative pain after back surgery. Further rigorously designed clinical trials are required. [ABSTRACT FROM AUTHOR]