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Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The randomized controlled trial (RCT) is the gold standard for evaluating the causal effects of medications. Limitations of RCTs have led to increasing interest in using real‐world evidence (RWE) to augment RCT evidence and inform decision making on medications. Although RWE can be either randomized or nonrandomized, nonrandomized RWE can capitalize on the recent proliferation of large healthcare databases and can often answer questions that cannot be answered in randomized studies due to resource constraints. However, the results of nonrandomized studies are much more likely to be impacted by confounding bias, and the existence of unmeasured confounders can never be completely ruled out. Furthermore, nonrandomized studies require more complex design considerations which can sometimes result in design‐related biases. We discuss questions that can help investigators or evidence consumers evaluate the potential impact of confounding or other biases on their findings: Does the design emulate a hypothetical randomized trial design? Is the comparator or control condition appropriate? Does the primary analysis adjust for measured confounders? Do sensitivity analyses quantify the potential impact of residual confounding? Are methods open to inspection and (if possible) replication? Designing a high‐quality nonrandomized study of medications remains challenging and requires broad expertise across a range of disciplines, including relevant clinical areas, epidemiology, and biostatistics. The questions posed in this paper provide a guiding framework for assessing the credibility of nonrandomized RWE and could be applied across many clinical questions. [ABSTRACT FROM AUTHOR]

Background: Many people with aphasia have word‐finding difficulties, with some showing particular difficulties with verbs. Picture‐naming therapy is often used to improve naming, but gains are usually limited to therapy items and do not transfer to conversation. Therapy where words are produced in sentences and in real‐life activities may be more effective. Aims: The current pilot study investigated whether an activity‐oriented therapy approach would be accepted and viable if implemented in a community setting, and whether communicating whilst cooking was more beneficial than using paper‐based activities. If successful, it would be expected that verb production would improve in structured and unstructured tasks in both naming and narrative tasks. Methods & Procedures: The study employed a case‐series repeated‐measures design, with testing of treated and control items. Seven adults with anomia participated, although only five completed the full programme. Participants were divided into two groups and each group completed both treatments, but in different orders. Each treatment was employed for six 2‐h sessions over a 3‐week period. Outcomes & Results: Naming of both treated and untreated verbs showed a statistically significant improvement following both treatments and this continued into the maintenance phase. There was a numerical but not statistically significant gain in the variety of verbs used in spoken narratives. Participants predominantly chose positive terms to describe their experience of the programme, but did not prefer one therapy over the other. Conclusions & Implications: Preliminary findings suggest that an activity‐oriented therapy approach, whether it involves carrying out tasks or paper‐based activities, can result in clinically meaningful improvements for people with chronic aphasia. Further research using a randomized control trial is required to determine whether cooking therapy alone is effective. [ABSTRACT FROM AUTHOR]

The review focuses on the last decade of research regarding the use of various oral appliances ( OAs) in the management of sleep bruxism ( SB) in adults. Sixteen ( n = 16) papers of 641 identified citations involving 398 participants were included in the review. Of them, seven were randomised controlled trials ( RCTs), seven were uncontrolled before-after studies and two were crossover trials. Analysis of the included articles revealed a high variability of study designs and findings. Generally, the risk of bias was low-to-unclear for RCTs and high for crossover studies, whilst the before-after studies exhibited several structural limitations. Nine studies used polysomnography/polygraphy/electromyography for SB diagnosis, whilst others were based on history taking and clinical examination. Most of them featured small samples and were short term. Of the studies using objective SB evaluations, eight showed positive results for almost every type of OA in reducing SB activity, with a higher decrease for devices that are designed to provide a certain extent of mandibular advancement. Among the studies using a subjective SB evaluation, one demonstrated a significant reduction in SB activity, and additional two showed a myorelaxant effect of OA in SB patients. Although many positive studies support the efficiency of OA treatment for SB, accepted evidence is insufficient to support its role in the long-term reduction of SB activity. Further studies with larger samples and sufficient treatment periods are needed to obtain more acknowledgements for clinical application. [ABSTRACT FROM AUTHOR]

SHIFT has been one of the largest RCTs in the field of systemic family therapy in the UK. The study took place over five years, including three major centres with fifteen Trusts and twenty‐five family therapists who worked with a manualized treatment in CAMHS with adolescents who self‐harmed. While the results are not available at the time of this publication, this paper will briefly describe the pre‐ existing factors which were helpful in developing a successful bid, clinical and managerial elements of ‘real world research’ of complex psychological processes and the construction of the manualized systemic family therapy. It also offers examples of some of the unanticipated events in the life of such a large trial. Practitioner Points: Large trials develop from small studies and clinicians are urged to look for opportunities for research partnershipsInvestment in time for consideration of difficult issues as they arise is essential for effective trial managementThe balance between research rigour and ‘real life’ practice is an inevitable area of tension and requires consideration of both immediate and outcome consequences 尝试和痛苦 – 一种随机对照试验对比下的把干预当作惯常和在实施过程中出现的重要事件上的反思的家庭治疗 人工家庭治疗 摘要: SHIFT目前是英国家庭治疗领域最大的随机对照试验之一。本研究历时5年, 囊括了三个主要的中心在内的15个信托, 25位曾在CAMHS对自残青少年进行人工治疗的家庭治疗师。因为在发表这篇文章的时候, 结果还没有出来, 本文将简短地描述1）有助发展成功bid的已经存在的因素, 2）临床以及管理方面的复杂心理过程的”真实情况研究”元素, 3）以及人工系统家庭治理的建构。本文还提供了生活在这样一种大的的尝试下的一些意想不到事件的例子。 对实践者有用的几点建议: 大的尝试发展自小的研究, 临床工作者急需寻找研究合作者的机会困难事件需要及时解决, 不然就会对有效尝试管理产生重要影响研究活力和”真实生活”实践的平衡是一种不可避免的引起紧张的领域, 这需要对当下和结果的同时考虑 关键词：实证实践, 研究, 儿童和青少年精神健康, 培训 [ABSTRACT FROM AUTHOR]

The article presents the results of a randomised controlled trial regarding the efficacy of carprofen and local anaesthesia in reducing the disbudding pain in calves. Researchers concluded that the use of systemic carprofen and lidocaine local anaesthetics can reduce the pain-related behaviours of calves in 24 hours after the disbudding procedure. Details on the methods and weaknesses of the study are also given.

Evidence‐based medicine (EBM) proponents have argued that mechanistic evidence concerning medical treatments should be considered secondary to evidence derived from randomized controlled trials (RCTs). One common criticism of RCTs is that they often do not yield results that are generalizable to clinical practice, and that for clinical practice application, mechanistic evidence is needed. However, proponents of EBM have argued that mechanistic reasoning is often unreliable and thus not very useful. Here we suggest an important role of mechanistic explanation that has been left out of this discussion entirely, namely, its importance in a patient's decision of whether or not to take certain drugs. We argue that in certain cases, knowing how a treatment works is just as important for the patient as knowing whether it does. In this paper, we explore how and why giving patients mechanistic information can be an important factor in obtaining informed consent for medical treatment, focusing on the example case of hormonal contraceptives. [ABSTRACT FROM AUTHOR]

Background and purpose Regular rehabilitation is not sufficient for regaining function after a hip fracture, and more targeted interventions for home-dwelling elderly hip-fracture patients are needed. This paper describes the protocol of a study assessing the effectiveness and cost effectiveness of a task specific progressive gait and balance exercise programme for hip-fracture patients, performed 4 months after the fracture. Methods/design A single blind two-arm pragmatic randomised controlled trial was conducted with 142 hip-fracture patients randomized to a 10-week home-based exercise programme or to practice as usual 4 months following the surgery. Inclusion criteria were age >70 years and being home dwelling prior to the fracture. Exclusion criteria are life expectancy <3 months and inability to walk 10 m prior to the fracture. The content and organization of the programme was developed in collaboration between physiotherapy researchers and primary health-care physiotherapists. Participants were followed for 1 year post-surgery, evaluating short-term and long-term effects of the programme. The primary outcome is gait speed, and the secondary outcomes are spatial and temporal gait parameters, free living physical behaviour by activity monitoring, mobility performance, activities of daily living, fear of falling, cognitive function, depression and health-related quality of life. Cost-effectiveness analysis is planned. Discussion This paper describes a task specific exercise programme aimed to improve gait and balance after a hip fracture. Inclusion started in February 2011, and the last 1-year follow-up is performed in March 2014. Broad inclusion criteria and physiotherapy-guided home-based exercises may facilitate the participation from frail patients and thereby increase the generalizability of the findings. Development and completion of the intervention within routine clinical practice will enlighten the implementation of results into clinical practice. Results may add new insight into how physiotherapy can improve gait and thereby activity and functioning in everyday life and have implications on future content and organization of physiotherapy after a hip fracture. Copyright © 2014 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

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

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Behavioral treatments in the management of primary headache disorders in adults and children are increasingly being recognized as effective; however, the level and durability of their effectiveness is still a matter of debate. This review aims to provide more updated information on the effects of behavioral therapies in adults and adolescents with primary headache disorders, with a special focus on new and emerging behavioral treatments. Methods: We searched SCOPUS for peer‐reviewed papers that reported randomized controlled trial or observational studies addressing behavioral treatment for headache disorders published in the period January 2010 to October 2017. Results: A total of 22 publications, in which 2110 participants were recruited, were included in the review. Most of the studies referred to cognitive behavioral therapies, and a reduction of headache frequency higher than 35% was generally reported irrespective of the approach. In addition, valuable impact disability and quality of life was observed, as well as improvements in depression, anxiety, self‐efficacy, and intake of medications. Conclusions: Behavioral approaches are effective and less prone to produce side or harmful effects, which makes them a valid option particularly for women who are pregnant or nursing, people with other chronic conditions requiring pharmacological treatments putting them at risk for drug‐drug interactions, and children. [ABSTRACT FROM AUTHOR]

Purpose To critically appraise scientific evidence regarding the efficacy of nutritional supplementation with omega-3 and omega-6 fatty acids for the treatment of dry eye syndrome (DES). Methods A systematic review of randomized clinical trials was performed. Two independent reviewers selected and analysed the scientific papers that met inclusion and exclusion criteria. Objective and subjective efficacy outcomes were assessed. Results The trials involved a total of 2591 patients in fifteen independent studies. All studies were published between 2005 and 2015. The supplements used were mostly omega-3 and omega-6 in different proportions. Subjective improvement was measured using mainly Ocular Surface Disease Index ( OSDI) test and Dry Eye Severity Score ( DESS) test: significant differences in favour of the experimental group were found in seven of the studies. The objective amelioration was assessed by lacrimal function parameters: Tear break-up time ( TBUT) significantly increased in nine studies and Schirmer's test in four studies. Conclusion We observed a discrete improvement in the parameters of tear function. Scientific evidence is not strong enough to systematically recommend the use of omega-3 and omega-6 fatty acids as a standalone treatment of DES independently from its aetiology. However, they could be considered as an effective alternative to topical treatment in patients with DES secondary to certain pathologies. [ABSTRACT FROM AUTHOR]

Exposure-based psychological interventions currently represent the empirically best established first line form of cognitive-behavioural therapy for all types of anxiety disorders. Although shown to be highly effective in both randomized clinical and other studies, there are important deficits: (1) the core mechanisms of action are still under debate, (2) it is not known whether such treatments work equally well in all forms of anxiety disorders, including comorbid diagnoses like depression, (3) it is not known whether an intensified treatment with more frequent sessions in a shorter period of time provides better outcome than distributed sessions over longer time intervals. This paper reports the methods and design of a large-scale multicentre randomized clinical trial (RCT) involving up to 700 patients designed to answer these questions. Based on substantial advances in basic research we regard extinction as the putative core candidate model to explain the mechanism of action of exposure-based treatments. The RCT is flanked by four add-on projects that apply experimental neurophysiological and psychophysiological, (epi)genetic and ecological momentary assessment methods to examine extinction and its potential moderators. Beyond the focus on extinction we also involve stakeholders and routine psychotherapists in preparation for more effective dissemination into clinical practice. [ABSTRACT FROM AUTHOR]

Background Psychological interventions for bipolar disorders typically produce mixed outcomes and modest effects. The need for a more effective intervention prompted the development of a new cognitive behavioural therapy, based on an integrative cognitive model ('Think Effectively About Mood Swings' [TEAMS] therapy). Unlike previous interventions, TEAMS addresses current symptoms and comorbidities, and helps clients achieve long-term goals. A pilot randomized controlled trial (the TEAMS trial) of the therapy has recently concluded. This study explored participants' experiences of TEAMS, recommendations for improvement and experiences of useful changes post-therapy. Methods Fourteen TEAMS therapy participants took part in semi-structured interviews. Their accounts were analysed using interpretative thematic analysis. Two researchers coded the dataset independently. Member checks were conducted of the preliminary themes. Results Two overarching themes; 'useful elements of therapy' and 'changes from therapy' encompassed 12 emerging subthemes. Participants appreciated having opportunities to talk and described the therapy as person-centred and delivered by caring, approachable and skilled therapists. Some recommended more sessions than the 16 provided. Helpful therapeutic techniques were reported to be, normalization about moods, methods to increase understanding of moods, relapse-prevention, reappraisal techniques and metaphors. However, some did not find therapeutic techniques helpful. Post-therapy, many reported changes in managing mood swings more effectively and in their thinking (although some participants reported changes in neither). Many described increased acceptance of themselves and of having bipolar disorder, increased productivity and reduced anxiety in social situations. Conclusions The present study evaluates participants' therapy experiences in detail, including aspects of therapy viewed as helpful, and meaningful post-therapy outcomes. Copyright © 2016 John Wiley & Sons, Ltd. Key Practitioner Message This is the first paper to qualitatively explore people's experiences of individual psychotherapy for bipolar disorders. It highlights elements of psychotherapy described as particularly helpful or unhelpful and the clinical changes viewed as most impactful., Participants reported benefitting in a number of ways from TEAMS therapy. They valued learning to reappraise and problem-solve situations and manage moods., Participants identified TEAMS techniques as helpful, such as exploring advantages and disadvantages of moods, and building healthy self-states. [ABSTRACT FROM AUTHOR]

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

Objective We aimed to explore whether the prevalence of manic switch was underestimated in randomized controlled trials ( RCTs) compared to observational studies ( OSs). Method Meta-analyses and simple and systematic reviews were identified by two reviewers in a blinded, standardized manner. All relevant references were extracted to include RCTs and OSs that provided data about manic switch prevalence after antidepressant treatment for a major depressive episode. The primary outcome was manic switch prevalence in the different arms of each study. A meta-regression was conducted to quantify the impact of certain variables on manic switch prevalence. Results A total of 57 papers (35 RCTs and 22 OSs) were included in the main analysis. RCTs underestimated the rate of manic switch [0.53 (0.32-0.87)]. Overestimated prevalence was related to imipraminics [1.85 (1.22-2.79)]; to serotonin-norepinephrine reuptake inhibitors [1.74 (1.06-2.86)]; and to other classes of drugs [1.58 (1.08-2.31)], compared to placebo treatment. The prevalence of manic switch was lower among adults than among children [0.2 (0.07-0.59)]; and higher [20.58 (8.41-50.31)] in case of bipolar disorder. Conclusion Our results highlight an underestimation of the rates of manic switch under antidepressants in RCTs compared to the rates observed in observational studies. [ABSTRACT FROM AUTHOR]

ABSTRACT Background The IO route is an established method of obtaining vascular access in children in acute and emergency situations and is now increasingly being used in adults as an alternative to intravenous access, yet a paucity of evidence exists regarding its use, effectiveness and implementation. Aim and objectives The aim of this literature review is to present a detailed investigation critiquing contemporary practices of intraosseous (IO) vascular access in adult patients. Specific objectives identified led to the exploration of clinical contexts, IO device/s and anatomical sites; education and training requirements; implications and recommendations for emergency health care practice and any requirements for further research. Search strategies An exploratory literature review was undertaken in acknowledgement of the broad and complex nature of the project aim. Five electronic search engines were examined iteratively from June 2013 to February 2014. The search terms were 'intraosseous' and 'adult' which were purposely limited because of the exploratory nature of the review. Studies that met the inclusion criteria of primary research articles with an adult focus were included. Research with a paediatric focus was excluded. Secondary research, reviews, case reports, editorials and opinion papers were excluded. Conclusion IO vascular access is considered an alternative intravascular access route although debate considering the preferred anatomical site is ongoing. Documented practices are only established in pre-hospital and specialist emergency department settings; however, variety exists in policy and actual practice. Achieving insertion competence is relatively uncomplicated following minimal preparation although ongoing skill maintenance is less clear. IO vascular access is associated with minimal complications although pain is a significant issue for the conscious patient especially during fluid administration. Relevance to clinical practice The IO route is clearly a valuable alternative to problematic intravascular access. However, further research, including cost effectiveness reviews, is required to gain clarity of whole acute care approaches. [ABSTRACT FROM AUTHOR]

The present paper reports on a 5-year follow-up of a randomized reading intervention in grade 3 in Sweden. An intervention group (n = 57) received daily training for 12 weeks in phoneme/grapheme mapping, reading comprehension and reading speed, whereas a control group (n = 55) participated in ordinary classroom activities. The main aim was to investigate if there were remaining effects of the intervention on reading-related skills. Previous analyses showed that the intervention group performed significantly better than the control group on spelling, reading speed, reading comprehension and phoneme awareness at the immediate post-test with sustained effects 1 year later. Results from the 5-year follow-up show that the only significant difference between the intervention (n = 47) and the control group (n = 37) was on word decoding. There was also a significant interaction effect of group assignment and initial word decoding, in the way that the lowest-performing students benefitted the most from the intervention. Another aim was to examine if the children identified in a screening (n = 2212) as poor readers in grade 2 still performed worse than typical readers. The analyses showed that the typically developing students (n = 66) outperformed the students identified as poor readers in grade 2 on working memory, spelling, reading comprehension and word decoding. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

A repeated dose of an oral triptan has been shown in randomized controlled trials (RCTs) to be ineffective as a treatment for no or partial response 2 hours after initial dosing but effective as treatment for headache recurrence. In the official prescription information in the United States, the United Kingdom, and Denmark repeated dosing of all seven oral triptans are recommended for headache recurrence but some triptans are also recommended for no or partial response, a use of a triptan deemed to be not beneficial in European and Canadian migraine guidelines. In summary, not all recommendations are based on evidence from RCTs. In addition, some recommendations are ambiguous and patients need clearer instructions. An example of such a clear British instruction in a patient leaflet instruction is presented at the end of the paper. [ABSTRACT FROM AUTHOR]

Background The primary goals in conducting clinical trials of treatments for alcohol use disorders ( AUDs) are to identify efficacious treatments and determine which treatments are most efficacious for which patients. Accurate reporting of study design features and results is imperative to enable readers of research reports to evaluate to what extent a study has achieved these goals. Guidance on quality of clinical trial reporting has evolved substantially over the past 2 decades, primarily through the publication and widespread adoption of the Consolidated Standards of Reporting Trials statement. However, there is room to improve the adoption of those standards in reporting the design and findings of treatment trials for AUD. Methods This paper provides a narrative review of guidance on reporting quality in AUD treatment trials. Results Despite improvements in the reporting of results of treatment trials for AUD over the past 2 decades, many published reports provide insufficient information on design or methods. Conclusions The reporting of alcohol treatment trial design, analysis, and results requires improvement in 4 primary areas: (i) trial registration, (ii) procedures for recruitment and retention, (iii) procedures for randomization and intervention design considerations, and (iv) statistical methods used to assess treatment efficacy. Improvements in these areas and the adoption of reporting standards by authors, reviewers, and editors are critical to an accurate assessment of the reliability and validity of treatment effects. Continued developments in this area are needed to move AUD treatment research forward via systematic reviews and meta-analyses that maximize the utility of completed studies. [ABSTRACT FROM AUTHOR]

Background Over the past 60 years, the view that 'alcoholism' is a disease for which the only acceptable goal of treatment is abstinence has given way to the recognition that alcohol use disorders ( AUDs) occur on a continuum of severity, for which a variety of treatment options are appropriate. However, because the available treatments for AUDs are not effective for everyone, more research is needed to develop novel and more efficacious treatments to address the range of AUD severity in diverse populations. Here we offer recommendations for the design and analysis of alcohol treatment trials, with a specific focus on the careful conduct of randomized clinical trials of medications and nonpharmacological interventions for AUDs. Methods This paper provides a narrative review of the quality of published clinical trials and recommendations for the optimal design and analysis of treatment trials for AUDs. Results Despite considerable improvements in the design of alcohol clinical trials over the past 2 decades, many studies of AUD treatments have used faulty design features and statistical methods that are known to produce biased estimates of treatment efficacy. Conclusions The published statistical and methodological literatures provide clear guidance on methods to improve clinical trial design and analysis. Consistent use of state-of-the-art design features and analytic approaches will enhance the internal and external validity of treatment trials for AUDs across the spectrum of severity. The ultimate result of this attention to methodological rigor is that better treatment options will be identified for patients with an AUD. [ABSTRACT FROM AUTHOR]

Background Despite harmful drinking causing a significant burden on global health, there is a large treatment gap, especially in low- and middle-income countries. A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments. This paper describes the systematic process used to develop Counselling for Alcohol Problems ( CAP), a brief psychological treatment (PT) for delivery by lay counselors in routine primary care settings to men with harmful drinking in India. Methods CAP was developed using a methodology involving 3 sequential steps: (i) identifying potential treatment strategies; (ii) developing a theoretical framework for the treatment; and (iii) evaluating the acceptability and feasibility of the treatment. Results CAP is a 3-phase treatment delivered over 1 to 4 sessions based on a motivational interviewing ( MI) stance and involves the following strategies: assessment and personalized feedback, family engagement, drink refusal skills, skills to address drinking urges, problem-solving skills and handling difficult emotions, and relapse prevention and management. Data from a case series were used to inform several adaptations to enhance the acceptability of CAP to the recipients and feasibility of delivery by lay counselors of the treatment, for example expansion of the target group to include alcohol-dependent patients and the extension of the delivery settings to include home-based delivery. There was preliminary evidence of the effectiveness of CAP. Conclusions CAP is an acceptable brief PT for harmful drinking delivered by lay counselors in primary care whose effectiveness is currently being tested in a randomized controlled trial based in primary care in Goa, India. [ABSTRACT FROM AUTHOR]

Background The effectiveness of two treatment approaches (phonological therapy and articulation therapy) for treatment of 14 children, aged 4;0-6;7 years, with phonologically based speech-sound disorder (SSD) has been previously analysed with severity outcome measures (percentage of consonants correct score, percentage occurrence of phonological processes and phonetic inventory). Considering that the ultimate goal of intervention for children with phonologically based SSD is to improve intelligibility, it is curious that intervention studies focusing on children's phonology do not routinely use intelligibility as an outcome measure. It is therefore important that the impact of interventions on speech intelligibility is explored. Aims This paper investigates the effectiveness of the two treatment approaches (phonological therapy and articulation therapy) using intelligibility measures, both in single words and in continuous speech, as the primary outcome. Methods & Procedures Fourteen children with phonologically based SSD participated in the intervention. The children were randomly assigned to phonological therapy or articulation therapy (seven children in each group). Two assessment methods were used for measuring intelligibility: a word identification task (for single words) and a rating scale (for continuous speech). Twenty-one unfamiliar adults listened and judged the children's intelligibility. Reliability analyses showed overall high agreement between listeners across both methods. Outcomes & Results Significant improvements were noted in intelligibility in both single words (paired t(6) = 4.409, p = 0.005) and continuous speech (asymptotic Z = 2.371, p = 0.018) for the group receiving phonology therapy pre- to post-treatment, but no differences in intelligibility were found for those receiving the articulation therapy pre- to post-treatment, either for single words (paired t(6) = 1.763, p = 0.128) or continuous speech (asymptotic Z = 1.442, p = 0.149). Conclusions & Implications Intelligibility measures were sensitive enough to show changes in the phonological therapy group but not in the articulation therapy group. These findings emphasize the importance of using intelligibility as an outcome measure to complement the results obtained with other severity measures when exploring the effectiveness of speech interventions. This study presents new evidence for the effectiveness of phonological therapy in improving intelligibility with children with SSD. [ABSTRACT FROM AUTHOR]

Background: The short dating period of room temperature-stored platelets (PLTs; 5-7 days) limits their availability at far-forward combat facilities and at remote civilian sites in the United States. PLT cryopreservation in 6% DMSO and storage for up to 2 years may improve timely availability for bleeding patients.Study Design and Methods: A dose escalation trial of DMSO-cryopreserved PLTs (CPPs) compared to standard liquid-stored PLTs (LSPs) was performed in bleeding patients with thrombocytopenia. Within each of four cohorts, six patients received escalating doses of CPP (0.5 unit, 1 unit, and sequential transfusions of 2 and 3 units) and one received a LSP transfusion. Patients were monitored for adverse events (AEs), coagulation markers, PLT responses, and hemostatic efficacy.Results: Patients with a World Health Organization bleeding score of 2 or more received from 0.5 to 3 units of CPP (n = 24) or 1 unit of LSP (n = 4). There were no related thrombotic or other serious AEs experienced. Mild transfusion-related AEs of chills and fever (n = 1), transient increased respiratory rate (n = 1), DMSO-related skin odor (n = 2), and headache (n = 1) were observed after CPP transfusion. Among CPP recipients 14 of 24 (58%) had improved bleeding scores, including three of seven (43%) patients who had intracerebral bleeding. CPP posttransfusion PLT increments were significantly less than those of LSPs; however, days to next transfusion were the same. After transfusion, the CPP recipients had improvements in some variables of thrombin generation tests and thromboelastography.Conclusion: Cryopreserved PLT transfusions appear to be safe and effective when given to bleeding patients with thrombocytopenia. [ABSTRACT FROM AUTHOR]

Background: Vitiligo was an autoimmune disease and some guidelines for the management of vitiligo encouraged the use of NB‐UVB combination therapies to enhance repigmentation. Objectives: To compare the effectiveness of current NB‐UVB combination regimen at the improvement in repigmentation through a systematic review and network meta‐analysis. Methods: We searched the electronic databases for randomized controlled trials related to NB‐UVB combination therapy for vitiligo till October 2022. STATA15.0 software was applied to carrying out data analysis. Results: A total of 28 eligible studies involving 1194 participants were enrolled in the analysis. The NMA results revealed that compared with NB‐UVB, carboxytherapy [OR = 32.35, 95% CI (1.79, 586.05)], Er: YAG laser+ topical 5% 5‐FU [OR = 10.74, 95% CI (4.05, 28.49)], needling/micro‐needling [OR = 3.42, 95% CI (1.18, 9.88)], betamethasone intramuscular injection [OR = 3.08, 95% CI (1.17, 8.13)], topical tacrolimus [OR = 2.54, 95% CI (1.30, 4.94)], and oral Chinese herbal medicine compound [OR = 2.51, 95% CI (1.40, 4.50)] integrated with NB‐UVB were more efficacious in excellent to complete repigmentation response rate (≥75%). Besides, NB‐UVB+ Er: YAG laser+ topical 5% 5‐FU [OR = 0.17, 95% CI (0.04, 0.67)] and NB‐UVB+ needling/micro‐needling [OR = 0.24, 95% CI (0.06, 0.88)] were less likely evaluated as ineffective repigmentation response (≤25%). Conclusions: All combination therapies ranked higher than NB‐UVB monotherapy in inducing successful repigmentation and avoiding failed treatment in patients with vitiligo. Comprehensive consideration, NB‐UVB+ Er: YAG laser+ topical 5% 5‐FU and NB‐UVB+ needling/microneedling would be the preferred therapeutic approaches. [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]

Background: Fluid treatment in sepsis is a challenge and clinical equipoise exists regarding intravenous (IV) volumes. We aimed to determine whether a 24‐h protocol restricting IV fluid was feasible in adult patients with sepsis without shock presenting to the emergency department (ED). Methods: The REFACED Sepsis trial is an investigator‐initiated, multicenter, randomized, open‐label, feasibility trial, assigning sepsis patients without shock to 24 h of restrictive, crystal IV fluid administration or standard care. In the IV fluid restriction group fluid boluses were only permitted if predefined criteria for hypoperfusion occurred. Standard care was at the discretion of the treating team. The primary outcome was total IV crystalloid fluid volumes at 24 h after randomization. Secondary outcomes included total fluid volumes, feasibility measures, and patient‐centered outcomes. Results: We included 123 patients (restrictive 61 patients and standard care 62 patients) in the primary analysis. A total of 32% (95% confidence interval [CI] 28%–37%) of eligible patients meeting all inclusion criteria and no exclusion criteria were included. At 24 h, the mean (±SD) IV crystalloid fluid volumes were 562 (±1076) ml versus 1370 (±1438) ml in the restrictive versus standard care group (mean difference –801 ml, 95% CI −1257 to −345 ml, p = 0.001). Protocol violations occurred in 21 (34%) patients in the fluid‐restrictive group. There were no differences between groups in adverse events, use of mechanical ventilation or vasopressors, acute kidney failure, length of stay, or mortality. Conclusions: A protocol restricting IV crystalloid fluids in ED patients with sepsis reduced 24‐h fluid volumes compared to standard care. A future trial powered toward patient‐centered outcomes appears feasible. [ABSTRACT FROM AUTHOR]

Emergency Use Authorization (EUA) allows the US Food and Drug Administration (FDA) to expedite the availability of therapeutics in the context of a public health emergency. To date, an evidentiary standard for clinical efficacy to support an EUA has not yet been established. This review examines the clinical data submitted in support of EUA for antiviral and anti‐inflammatory therapeutics for coronavirus disease 2019 (COVID‐19) through December of 2021 and the resilience of the authorization as new clinical data arose subsequent to the authorization. In the vast majority of cases, EUA was supported by at least one well‐powered randomized controlled trial (RCT) where statistically significant efficacy was demonstrated. This included branded medications already approved for use outside of the context of COVID‐19. When used, the standard of a single RCT seemed to provide adequate evidence of clinical efficacy, such that subsequent clinical studies generally supported or expanded the EUA of the therapeutic in question. The lone generic agent that was granted EUA (chloroquine/hydroxychloroquine) was not supported by a well‐controlled RCT, and the EUA was withdrawn within 3 months time. This highlighted not only the ambiguity of the EUA standard, but also the need to provide avenues through which high quality clinical evidence for the efficacy of a generic medication could be obtained. Therefore, maintaining the clinical trial networks assembled during the COVID‐19 pandemic could be a critical component of our preparation for future pandemics. Consideration could also be given to establishing a single successful RCT as regulatory guidance for obtaining an EUA. [ABSTRACT FROM AUTHOR]

Background and Objectives: We examined youth recovery outcomes at 6- and 9-months post-participation in an aftercare pilot study called Educating and Supporting inQuisitive Youth in Recovery (ESQYIR) that aimed to investigate the utility of a 12-week mobile texting recovery support intervention.Methods: A total of 80 youth [Mage 20.4 (SD = 3.5)] were randomized to a mobile texting aftercare intervention or an aftercare-as-usual control group. Both groups received identical data collection protocols with psychosocial and behavioral assessments occurring at baseline, during the trial (months 1 and 2), at discharge from the trial (month 3), and 3-, 6-, and 9-month post-intervention follow-ups.Results: Mixed modeling showed that youth who participated in the mobile texting aftercare intervention were less likely to test positive for their primary drug compared to youth in the aftercare-as-usual condition during 6- and 9-months follow-ups (p < .01). Additionally, youth in the aftercare intervention reported significantly higher self-efficacy/confidence to abstain during recovery (p < .05) and were more likely to participate in recovery-related behaviors (self-help and goal-directed extracurricular activities; p < .05) than those in aftercare-as-usual at the 6- and 9-month follow-ups.Conclusions: Results suggest that delivering a structured, behavioral-based wellness aftercare intervention using mobile texting can be an effective for sustaining recovery outcomes in youth over time compared to youth who receive aftercare-as-usual.Scientific Significance: This study shows that a mobile-texting aftercare intervention sustained effects at 6- and 9-months post-intervention for young people in substance use recovery. [ABSTRACT FROM AUTHOR]

Background: Metacognitive training for depression (D‐MCT) is a novel low‐intensity group training for economic treatment of depression. Previous studies demonstrate its efficacy in moderately depressed outpatients. The present study evaluated efficacy and patients' perspective of the D‐MCT in severely depressed psychiatric inpatients. Methods: In a randomized‐controlled trial, 75 individuals with a major depressive disorder (MDD) were allocated to D‐MCT versus euthymic therapy as add‐on (twice a week) to cognitive‐behavioural‐based (CBT) inpatient‐care. Depressive symptoms (HDRS, BDI), dysfunctional (meta)cognition (DAS, MCQ‐30) and subjective appraisal were assessed at baseline, 4 weeks (post) and 3 months (follow‐up). Results: Participants in both conditions showed a large decline in depression at post and follow‐up‐assessment. No superior add‐effect of D‐MCT versus active control emerged for depression severity on top of the inpatient care. However, among patients with a diagnosis of MDD with no (vs. at least one) comorbidity, D‐MCT participants showed a larger decline in depressive (meta‐)cognition at follow‐up with medium‐to‐large effect sizes. D‐MCT was evaluated as superior in overall appraisal, treatment preference, motivation and satisfaction. Limitations: The follow‐up time interval of 3 months may have been too short to detect long‐term effects. There is emerging evidence that modification of (meta)cognition unfolds its full effects only with time. Effects of CBT inpatient‐care on outcome parameters cannot be differentiated. Conclusions: Although D‐MCT as an add‐on was not superior in complete case analyses, results suggest greater benefit for patients with MDD and no comorbidity. D‐MCT proved feasible in acute‐psychiatric inpatient‐care and was highly accepted by patients. Future studies should investigate the role of modified (meta)cognition on long‐term treatment outcome, including dropout and relapse rates. [ABSTRACT FROM AUTHOR]

Background Both misoprostol and prostaglandin E2 (PGE2) gel are used for labor induction in women with premature rupture of membranes (PROM). Objectives To evaluate studies comparing the effects of misoprostol and PGE2 gel in labor induction. Search strategy Databases including Medline, Embase, and the Cochrane Central Register of Controlled Trials were searched for relevant papers. Selection criteria Randomized controlled trials comparing the use of misoprostol and PGE2 gel for labor induction in women with PROM were included. Data collection and analysis For meta-analyses, the Mantel–Haenszel method was used for dichotomous data, and the inverse variance method was used for continuous data. Main results Four randomized controlled studies (n = 615) were included. There were no significant differences between the two groups in the induction-to-delivery interval (mean difference – 4.44 hours; 95% confidence interval [CI] –9.35 to 0.48), rate of cesarean delivery (odds ratio [OR] 0.90; 95% CI 0.44–1.85), and rate of neonatal intensive care unit admission (OR 0.89; 95% CI 0.57–1.38). Women receiving misoprostol had a significantly higher rate of tachysystole than did those receiving PGE2 gel (OR 4.84; 95% CI 2.46–9.54). Conclusions Misoprostol is as efficacious and safe as PGE2 gel for labor induction in women with PROM. [ABSTRACT FROM AUTHOR]

Background: The efficacy and safety of sirolimus (SIR)-based graft-versus-host disease (GVHD) prophylaxis in patients who were subjected to allogeneic hematopoietic stem cell transplantation (allo-HSCT) remain to be clarified; this meta-analysis was conducted to evaluate these factors.Study Design and Methods: Data from original research were obtained from PubMed, Embase, and Cochrane central register of controlled trials databases. Randomized controlled trials (RCTs) evaluating the efficacy of SIR-based prophylaxis in allo-HSCT were included. The risk ratio (RR), with a 95% confidence interval (CI), was used to pool data. The random effects model was used, irrespective of the presence or absence of heterogeneity.Results: Five RCTs were included in the meta-analysis. SIR was observed to significantly decrease the incidence of Grade II to IV acute GVHD (aGVHD; RR, 0.65; 95% CI, 0.47-0.89). However, the incidence of Grade III to IV aGVHD and chronic GVHD was not decreased (RR, 0.91; 95% CI, 0.59-1.40; RR, 1.04; 95% CI, 0.88-1.23, respectively). An analysis of the toxic effects of SIR revealed that SIR effected a significant increase in the incidence of sinusoidal obstructive syndrome (RR, 2.24; 95% CI, 1.26-4.01), while that of thrombotic microangiopathy was not significantly increased (RR, 2.48; 95% CI, 0.87-7.06). Moreover, SIR did not improve event-free survival and overall survival (RR, 0.97; 95% CI, 0.85-1.10; and RR, 0.92; 95% CI, 0.82-1.02, respectively).Conclusion: This meta-analysis indicated that the SIR-based regimen is an effective and safe alternative prophylaxis strategy for GVHD. [ABSTRACT FROM AUTHOR]

Structured Abstract Objective To compare the effectiveness of distraction osteogenesis to orthognathic surgery for the treatment of maxillary hypoplasia in individuals with cleft lip and palate. Method A systematic review of prospective randomized, quasi-randomized or controlled clinical trials. MEDLINE, EMBASE, Scopus, Web of Science, CINAHL, CENTRAL, trial registers and grey literature were searched. Hand searching of five relevant journals was completed. Two reviewers independently completed inclusion assessment. Data extraction and risk of bias assessment were completed by a single reviewer and checked by a second reviewer. Results Five publications all reporting different outcomes of a single randomized controlled trial are included within the review. The quality of the evidence was low with a high risk of bias. Both surgical interventions produce significant soft tissue improvement. Horizontal relapse of the maxilla was statistically significantly greater following orthognathic surgery. There was no statistically significant difference in speech and velo-pharyngeal function between the interventions. Maxillary distraction initially lowered social self-esteem, but this improved with time resulting in higher satisfaction with life in the long term. Conclusions The low quality of evidence included within the review means there is insufficient evidence to conclude whether there is a difference in effectiveness between maxillary distraction and osteotomy for the treatment of cleft-related maxillary hypoplasia. There is a need for further high-quality randomized controlled trials to allow conclusive recommendations to be made. [ABSTRACT FROM AUTHOR]

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real‐world evidence (RWE) in the evaluation of new treatments or products. The RWE label has been used to refer to a variety of departures from the methods of traditional randomized controlled trials. Recognizing this complexity and potential confusion, the National Academies of Science, Engineering, and Medicine convened a series of workshops to clarify and address questions regarding the use of RWE to evaluate new medical treatments. Those workshops identified three specific dimensions in which RWE studies might differ from traditional clinical trials: use of real‐world data (data extracted from health system records or data captured by mobile devices), delivery of real‐world treatment (open‐label treatments delivered in community settings by community practitioners), and real‐world treatment assignment (including nonrandomized comparisons and variations on random assignment such as before‐after or stepped‐wedge designs). For any RWE study, decisions regarding each of these dimensions depends on the specific research question, characteristics of the potential study settings, and characteristics of the settings where study results would be applied. [ABSTRACT FROM AUTHOR]

Background and aims: Evidence for efficacy of brief alcohol interventions (BAIs) is mainly limited to primary care and at‐risk drinkers. The aim was to test the efficacy of a BAI addressing the full spectrum of alcohol use in a general population sample and across alcohol risk groups. Design Two‐parallel‐group randomized controlled trial (allocation ratio 1:1) with post‐baseline assessments at months 3, 6 and 12. Setting: One municipal registry office in Germany responsible for registration, passport and vehicle admission issues. Participants: A total of 1646 proactively recruited 18–64‐year‐old adults with past year alcohol use (56% women, 66% low‐risk drinkers) were randomized to intervention (n = 815) or control (n = 831). Intervention and comparator: The intervention consisted of assessment plus computer‐generated individualized feedback letters at baseline and months 3 and 6. Comparator was assessment only. Measurements Primary outcome was change in the self‐reported number of drinks/week from baseline to 12 months. Changes at 3 and 6 months were secondary outcomes. Moderator was alcohol risk group (low‐risk versus at‐risk drinking) according to the Alcohol Use Disorders Identification Test–Consumption, with scores from 1‐3 (women) and from 1‐4 (men) indicating low‐risk drinking. Findings For the whole sample, significant group differences were observed neither at 12‐month follow‐up [incidence rate ratio (IRR) = 1.01, 95% confidence interval (CI) = 0.87–1.17, Bayes factor (BE) = 0.52] nor at previous assessments (month 3: IRR = 1.01, 95% CI = 0.92–1.12, BE = 0.41; month 6: IRR = 0.93, 95% CI = 0.81–1.07, BE = 1.10). Moderator analyses revealed that low‐risk drinkers were more likely to benefit from BAI only at month 6 than at‐risk drinkers (IRR = 0.77, 95% CI = 0.70–0.86). Conclusions: In a randomized controlled trial, there was no clear evidence for efficacy of a computer‐based brief alcohol intervention in a general population sample, but there was some evidence of medium‐term benefits in the large but understudied group of low‐risk drinkers. [ABSTRACT FROM AUTHOR]

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

Background: There is limited evidence supporting the use of alternative treatments for patients with nonstable vitiligo. Objective: This study aimed to review the effects of oral mini‐pulse (OMP) therapy in the management of nonsegmental vitiligo. Methods: The following databases were searched between inception and May 2020 for relevant studies: Scopus, Web of Science, MEDLINE, and Embase. All randomized controlled trials that compared OMP therapy with any other active treatment or placebo for nonstable vitiligo were included. The Cochrane's risk of bias tool was used to evaluate the risk of bias (ROB) in selected studies, and the overall quality of evidence of each outcome was assessed using the Grading Recommendations, Assessment, Development, and Evaluations (GRADE) system. Results: Four studies met our selection criteria. All of them were conducted in India and included 246 patients. OMP therapy included betamethasone or dexamethasone. The duration of treatment was 6 months in all studies. Up to 32% of patients achieved a repigmentation rate of >75% when OMP therapy was administered as monotherapy. No difference was observed between OMP therapy and other treatments in arresting the disease, and weight gain was the most frequent adverse effect. The overall ROB in all included studies was relatively high because of the randomization process, outcome measurement and informed selection of outcomes. Conclusion: Based on the findings of these studies, OMP therapy did not demonstrate additional value compared with other treatments. Hence, there is an urgent need to conduct high‐quality clinical trials to evaluate this therapy. [ABSTRACT FROM AUTHOR]

Explosive strength and balance training are commonly applied to enhance explosive strength and balance performance. Even though both training methods are frequently implemented, ordering effects have largely been neglected. Therefore, the present study aimed to investigate ordering effects of balance and explosive strength training on explosive strength and balance performance as well as changes in short‐interval intracortical inhibition (SICI). Two groups of subjects either participated in 4 weeks of balance training followed by 4 weeks of explosive strength training (BT‐ET) or vice versa (ET‐BT). Before, after 4 and 8 weeks, balance performance, as well as explosive strength, was tested. Additionally, SICI was tested during rest as well as during balance perturbations and explosive contractions. The results show a training specific increase in performance with an increase in balance control followed by an increase in explosive strength in the BT‐ET, while the ET‐BT increased its balance and explosive strength in the opposite order. There were no significant ordering effects. Both groups showed a significant decrease in SICI during the explosive contractions after the eight weeks of training. When SICI was tested during the balance perturbations, SICI initially increased after the first 4 weeks of training but returned to baseline until the end of the eight weeks. It is suggested that the decrease in SICI with prolonged training might show a disengagement of the motor cortex during the balance task. During the explosive contractions, the low SICI levels are beneficial to provide the necessary level of excitatory cortical drive. [ABSTRACT FROM AUTHOR]

Background: Computer‐based delivery of cognitive behavioral therapy (CBT) may be a less costly approach to increase dissemination and implementation of evidence‐based treatments for alcohol use disorder (AUD). However, comprehensive evaluations of costs, cost‐effectiveness, and cost–benefit of computer‐delivered interventions are rare. Methods: This study used data from a completed randomized clinical trial to evaluate the cost‐effectiveness and cost–benefit of a computer‐based version of CBT (CBT4CBT) for AUD. Sixty‐three participants were randomized to receive one of the following treatments at an outpatient treatment facility and attended at least one session: (1) treatment as usual (TAU), (2) CBT4CBT plus treatment as usual (CBT4CBT+TAU), or (3) CBT4CBT plus brief monitoring. Results: Median protocol treatment costs per participant differed significantly between conditions, Kruskal‐Wallis H(2) = 8.40, p = 0.02, such that CBT4CBT+TAU and CBT4CBT+monitoring each cost significantly more per participant than TAU. However, when nonprotocol treatment costs were included, total treatment costs per participant did not differ significantly between conditions. Median incremental cost‐effective ratios (ICERs) revealed that CBT4CBT+TAU was more costly and more effective than TAU. It cost $35.08 to add CBT4CBT to TAU to produce a reduction of one additional drinking day per month between baseline and the end of the 8‐week treatment protocol: CBT4CBT+monitoring cost $33.70 less to produce a reduction of one additional drinking day per month because CBT4CBT+monitoring was less costly than TAU and more effective at treatment termination, though not significantly so. Net benefit analyses suggested that costs of treatment, regardless of condition, did not offset monthly costs related to healthcare utilization, criminal justice involvement, and employment disruption between baseline and 6‐month follow‐up. Benefit–cost ratios were similar for each condition. Conclusions: Results of this pilot economic evaluation suggest that an 8‐week course of CBT4CBT may be a cost‐effective addition and potential alternative to standard outpatient treatment for AUD. Additional research is needed to generate conclusions about the cost–benefit of providing CBT4CBT to treatment‐seeking individuals participating in standard outpatient treatment. [ABSTRACT FROM AUTHOR]

Objective: This study examined the influence of physicians' recommendations and gender on the decision‐making process in a preference‐sensitive situation. Methods: N = 201 participants were put in a hypothetical scenario in which they suffered from a rupture of the anterior cruciate ligament (ACL). They received general information on two equally successful treatment options for this injury (surgery vs physiotherapy) and answered questions regarding their treatment preference, certainty and satisfaction regarding their decision and attitude towards the treatment options. Then, participants watched a video that differed regarding physician's recommendation (surgery vs physiotherapy) and physician's gender (female vs male voice and picture). Afterwards, they indicated again their treatment preference, certainty, satisfaction and attitude, as well as the physician's professional and social competence. Results: Participants changed their treatment preferences in the direction of the physician's recommendation (P <.001). Decision certainty (P <.001) and satisfaction (P <.001) increased more strongly if the physician's recommendation was congruent with the participant's prior attitude than if the recommendation was contrary to the participant's prior attitude. Finally, participants' attitudes towards the recommended treatment became more positive (surgery recommendation: P <.001; physiotherapy recommendation: P <.001). We found no influence of the physician's gender on participants' decisions, attitudes, or competence assessments. Conclusion: This research indicates that physicians should be careful with recommendations when aiming for shared decisions, as they might influence patients even if the patients have been made aware that they should take their personal preferences into account. This could be particularly problematic if the recommendation is not in line with the patient's preferences. [ABSTRACT FROM AUTHOR]

Aim: We performed a systematic review and meta‐analysis to compare the efficacy and safety of ticagrelor and prasugrel with those of clopidogrel in CYP2C19 reduced‐metabolizers. Methods: PubMed, Cochrane and Web of Science were systematically searched for randomized controlled trials or cohort studies up to January 2020. The primary endpoint was major adverse cardiovascular events (MACE), including cardiovascular (CV) death, all‐cause death, myocardial infarction (MI), stent thrombosis and stroke. The secondary endpoint was bleeding. Pooled effects were measured by relative risk (RR) with 95% confidence intervals (CIs). Publication bias was evaluated with Egger's regression test and adjusted by trim and fill method. Results: Twelve studies comprising 5829 CV patients with CYP2C19 loss‐of‐function alleles were included. Patients who received ticagrelor or prasugrel showed a lower risk of MACE than those who received clopidogrel (RR 0.524; 95% CI: 0.375, 0.731). The former also had lower risks of CV death (RR 0.409; 95% CI: 0.177, 0.946), all‐cause death (RR 0.441; 95% CI: 0.263, 0.739), MI (RR 0.554; 95% CI: 0.414, 0.741) and stent thrombosis (RR 0.587; 95% CI: 0.348, 0.988) than the latter patient group. The risk of stroke was not significantly different between patients receiving the alternatives and those receiving clopidogrel (RR 0.605; 95% CI: 0.257, 1.425). Major and minor bleeding risk was not significantly different between patients treated with alternatives and clopidogrel (RR 1.019; 95% CI: 0.827, 1.260 and RR 1.235; 95% CI: 0.581, 2.628, respectively). Conclusion: CYP2C19 reduced‐metabolizers can expect better clinical outcome on using prasugrel or ticagrelor rather than clopidogrel. [ABSTRACT FROM AUTHOR]

Objectives: Cariprazine is a partial agonist at D2/D3 receptors that has been approved for the treatment of mania associated with bipolar disorder (BD). This meta‐analysis aimed to assess the efficacy and tolerability of cariprazine in the treatment of BD. Methods: Randomized controlled trials investigating the efficacy of cariprazine in BD were included. Of the 391 studies yielded by search, 7 were included. The PRISMA protocol was followed and a set of analyses involving random‐effects model with restricted maximum‐likelihood estimator were used to synthesize effect sizes. Results: Cariprazine was associated with a moderate and significant reduction of manic symptoms based on YMRS change scores (SMD: −0.52; 95%CI: −0.82 to −0.21; P =.018). Cariprazine resulted in significantly higher remission (OR: 2.05; 95%CI: 1.61‐2.61; P =.006) and response rates (OR: 2.31; 95%CI: 1.35‐3.95; P =.021) for manic and mixed episodes compared with placebo. Both cariprazine 1.5 mg and 3 mg doses were associated with small but significant reduction in depressive symptoms assessed with MADRS scores (SMD: −0.26, 95%CI: −0.49 to −0.02; P =.040) (SMD: −0.21, 95%CI: −0.41 to −0.01; P =.045), respectively. Cariprazine was significantly associated with the development of adverse effects but not with dropouts due to these adverse effects, when compared to placebo. Conclusion: Cariprazine appears to be safe and efficacious in the treatment of acute mania and mixed episodes associated with BD. Cariprazine at doses of 1.5‐3 mg/day is efficacious in acute bipolar depression but the effect sizes were smaller. Controlled studies evaluating its efficacy for prophylaxis are needed. [ABSTRACT FROM AUTHOR]

The purpose of the study was to compare treatment of chronic rhinosinusitis (CRS) with topical glucocorticoids and saline irrigation versus aerosol inhalation therapy. Patients diagnosed with CRS were randomly divided into 2 groups. In the first group, patients were treated with topical glucocorticoids (mometasone furoate, 100 µg in each nostril once daily) and saline irrigation (150 mL twice a day) for 2 weeks. In the second group, patients were treated with inhalation aerosol therapy composed of essential oils, saline, glucocorticoids, and antibiotics, once daily 5 times per week (Monday through Friday), for 2 weeks. The effect of the treatments was compared between the 2 groups. In the first group there was no significant improvement in the Glasgow Health Status Inventory (GHSI) (P =.29). In the second group the improvement in GHSI score was significant (P =.037). It was shown that in the first group the Glasgow Benefit Inventory score was significantly lower than in the second group (P =.002), which means that the improvement in the health status after the therapy was better in the second group. A Lund‐Kennedy score showed statistical improvement in both groups (both P <.001). Improvement was also compared between the groups. The results were not significant (P =.11). The authors concluded that, in this preliminary research, inhalation aerosol therapy composed of essential oils, saline, glucocorticoids, and antibiotics led to better subjective results than intranasal glucocorticoid therapy and saline irrigation in the treatment of CRS. Further investigations with more participants, longer periods of treatment, and different validation tools are needed to confirm our results. [ABSTRACT FROM AUTHOR]

Objectives: This split‐mouth, double‐blind, randomized clinical trial evaluated the 1‐year bleaching efficacy produced by two hydrogen peroxide gels with different pHs. Materials and Methods: Twenty‐eight patients were divided into two groups corresponding to two different products: Pola Office (pH = 2.0/SDI) and Pola Office Plus (pH = 7.0/SDI). The treatment was assessed during and after the bleaching procedure up to 12 months post‐treatment. The assessment consisted of two bleaching scales shade guide units (ΔSGU) and spectrophotometric device (ΔE, ΔE00, and Whiteness Index) of both maxillary quadrants. Results for ΔSGUs in both scales and ΔE00 and Whiteness Index were compared using Mann Whitney test and ΔE measurements through the t‐Student test for paired samples in each evaluation time. The color rebound (1‐ vs 12‐month postbleaching data) was evaluated with Wilcoxon test (alpha =.05). Results: During the different times of evaluation, the color variation was similar for both products (P > .05), both for subjective (ΔSGUs) and objective assessments (ΔE, ΔE00, and Whiteness Index). Also, both products showed a slight rebound after 12‐month postbleaching (P > .05). Conclusions: Concerning the stability of color, in‐office dental whitening with two hydrogen peroxide gels of different pHs produced similar results, with no significant of regression, for 12 months postwhitening. Clinical Significance: Bleaching using a neutral (pH = 7.0) in‐office gel demonstrated similar stability and rebound effect than an acidic one (pH = 2.0). [ABSTRACT FROM AUTHOR]

Background: Conventional infiltration anaesthesia (CIA) is the most frequently used in paediatric oral health care. However, other techniques are available, such as intraosseous anaesthesia (IOA), that can beneficiate from newly developed technologies. Aim: To compare the pain caused by CIA and IOA delivered by the computerized system (QuickSleeper™) in children. Design: We used an innovative design consisting in simultaneously conducting a multicentre split‐mouth and parallel‐arm randomized controlled trial (RCT) to allow for increased power. The primary outcome was pain reported by the patient on a visual analogue scale (0‐10 cm) concerning the insertion of the needle and injection. Results: A total of 30 children were included in the split‐mouth RCT and 128 in the parallel‐arm RCT. We combined treatment effect estimates by using an inverse‐variance weighting meta‐analysis approach. Pain scores were significantly decreased with IOA vs CIA (mean difference −0.69 cm, 95% confidence intervals −1.13 to −0.25 cm). For each patient enrolled in the split‐mouth RCT, about five were enrolled in the parallel‐arm RCT, which allowed for not losing any eligible patients. Conclusion: Pain during the insertion of the needle and injection was less with IOA vs CIA in children. The design of this study allowed for increasing statistical power and using all generated evidence. (ClinicalTrials.gov NCT02084433). [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]

Aim: We aimed to systematically assess the evidence on the efficacy and safety of alpha‐blockers in patients with multiple sclerosis (MS) suffering from neurogenic lower urinary tract dysfunction (NLUTD). Methods: The Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) statement was used to perform this systematic review. An electronic search of Cochrane register, Embase, Medline, Scopus (last search 3 March 2018) and screening of reference lists as well as reviews were used to identify the studies. Articles were included if they reported on efficacy/safety of alpha‐blockers for the treatment of NLUTD in patients with MS. Results: After screening of 7′015 abstracts, three studies enrolling a total of 50 patients were included: one randomized, placebo‐controlled, single‐blind trial and two prospective cohort studies. Alpha‐blocker treatment was successful in 50% to 96% of the patients. Pooling data from the three included studies, the relative risk for successful alpha‐blocker treatment was 3.89 (95% confidence interval 2.7‐7.0). The general safety profile of alpha‐blockers was favorable with 8% of the patients reporting adverse events. Conclusions: Alpha‐blockers may be effective and safe for treating NLUTD in female and male patients with MS but the studies were small and the overall quality of evidence was low. To make definitive conclusions, well designed randomized controlled trials are highly warranted. [ABSTRACT FROM AUTHOR]

Traditional Chinese medicine (TCM) has recorded knowledge of diabetes for over 2000 years. Because a considerable number of TCM studies exhibit design defects, such as limited intervention duration, small sample sizes and inconsistent efficacy evaluations, the role of TCM in the treatment of diabetes cannot be fully elucidated. In this review, we evaluate randomized controlled trials of prediabetes, diabetes and diabetic complications published in the past decade. We found that TCM could significantly improve glucose control and clinical indices in patients with diabetes and effectively delay the progression of diabetes. We also summarize potential pharmacological mechanisms underlying the efficacy of TCM medication/herbs and their active ingredients for treating diabetes. More rigorously designed experiments and long‐term evaluation of TCM for diabetes will allow for more effective diabetes management. [ABSTRACT FROM AUTHOR]

Aim: The aim of this meta‐analysis of randomized trials was to assess the effects of SGLT‐2i on the overall incidence of malignancies and on different types of cancer, summerizing the results of trials with a duration of at least 1 year. This was done in light of the effect of SGLT‐2 inhibitors (SGLT‐2is) that has been highlighted by some studies, showing an increased incidence of bladder cancer, particularly with use of empagliflozin. Materials and methods: A Medline and Embase search for "Canaglifozin", "Dapaglifozin", "Empaglifozin", "Ertuglifozin", "Ipraglifozin", Tofoglifozin" or "Luseoglifozin" was performed, identifying randomized trials with a duration of more than 52 weeks up to 1 December 2018 that compared SGLT‐2is with placebo or active comparators. The outcomes considered were all types of cancer and several site‐specific cancers (ie, breast, pulmonary, gastrointestinal, hepatic, pancreatic, skin, prostate and bladder). Mantel–Haenszel odds ratios with 95% Confidence Intervals (MH‐OR, 95% CI) were calculated for all outcomes. Results: A total of 27 trials fulfilled the inclusion criteria. Retrieved trials had enrolled 27 744 and 20 441 patients in SGLT‐2 inhibitor and comparator groups, respectively. No difference was observed in the incidence of all malignancies between patients allocated to SGLT‐2i and comparators (MH‐OR 0.98[0.77–1.24]). The incidence of bladder cancer, and of any other type of cancer, was not significantly increased by treatment with any SGLT‐2i. Conclusions: Available data from randomized trials do not suggest a detrimental effect of SGLT‐2is on the incidence of malignancies in general, or in bladder cancer in particular. [ABSTRACT FROM AUTHOR]