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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]

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]

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]

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]

A randomized controlled trial is reported in which three treatments were compared for the management of depression in Primary Care. The treatments were Treatment As Usual (TAU) carried out by the General Practitioners, Cognitive-Behaviour Therapy (CBT) or Interpersonal Psychotherapy (IPT). Measurements of depressive symptomatology were taken at Baseline (Time1), at end of treatment (Time2), and at 5-month follow-up (Time3). An initial analysis of the longitudinal data revealed that there were a significant number of missing values, especially in the Time3 follow-up for the TAU group. That is, the missing data were not missing at random within the dataset, which is one of the considerations for usual procedures for replacement of missing values (RMV). The paper presents, therefore, the outcome of different approaches to RMV and their consequences for conclusions about the relative efficacy of the treatment conditions. The results showed that clients in all conditions improved significantly, with at least some analyses showing superiority of IPT and CBT at end of treatment Time 2. However, by the follow-up clients in all conditions performed equally well. Copyright © 2012 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

It is common for longitudinal clinical trials to face problems of item non-response, unit non-response, and drop-out. In this paper, we compare two alternative methods of handling multivariate incomplete data across a baseline assessment and three follow-up time points in a multi-centre randomized controlled trial of a disease management programme for late-life depression. One approach combines hot-deck (HD) multiple imputation using a predictive mean matching method for item non-response and the approximate Bayesian bootstrap for unit non-response. A second method is based on a multivariate normal (MVN) model using PROC MI in SAS software V8.2. These two methods are contrasted with a last observation carried forward (LOCF) technique and available-case (AC) analysis in a simulation study where replicate analyses are performed on subsets of the originally complete cases. Missing-data patterns were simulated to be consistent with missing-data patterns found in the originally incomplete cases, and observed complete data means were taken to be the targets of estimation. Not surprisingly, the LOCF and AC methods had poor coverage properties for many of the variables evaluated. Multiple imputation under the MVN model performed well for most variables but produced less than nominal coverage for variables with highly skewed distributions. The HD method consistently produced close to nominal coverage, with interval widths that were roughly 7 per cent larger on average than those produced from the MVN model. [ABSTRACT FROM AUTHOR]