Search

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.)

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]

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

Background 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]

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]

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 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]

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]

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]

Objective: To assess the short- and long-term effects of mindfulness-based stress reduction (MBSR) on the resulting quality of life, sexual functioning, and sexual distress after risk-reducing salpingo-oophorectomy (RRSO).Design: Randomised controlled trial.Setting: A specialised family cancer clinic of the university medical center Groningen.Population: Sixty-six women carriers of the BRCA1/2 mutation who developed at least two moderate-to-severe menopausal symptoms after RRSO.Methods: Women were randomised to an 8-week MBSR training programme or to care as usual (CAU).Main Outcome Measures: Change in the Menopause-Specific Quality of Life Questionnaire (MENQOL), the Female Sexual Function Index, and the Female Sexual Distress Scale, administered from baseline at 3, 6, and 12 months. Linear mixed modelling was applied to compare the effect of MBSR with CAU over time.Results: At 3 and 12 months, there were statistically significant improvements in the MENQOL for the MBSR group compared with the CAU group (both P = 0.04). At 3 months, the mean MENQOL scores were 3.5 (95% confidence interval, 95% CI 3.0-3.9) and 3.8 (95% CI 3.3-4.2) for the MBSR and CAU groups, respectively; at 12 months, the corresponding values were 3.6 (95% CI 3.1-4.0) and 3.9 (95% CI 3.5-4.4). No significant differences were found between the MBSR and CAU groups in the other scores.Conclusion: Mindfulness-based stress reduction was effective at improving quality of life in the short- and long-term for patients with menopausal symptoms after RRSO; however, it was not associated with an improvement in sexual functioning or distress.Tweetable Abstract: Mindfulness improves menopause-related quality of life in women after risk-reducing salpingo-oophorectomy. [ABSTRACT FROM AUTHOR]

Background: The ICON6 trial showed that cediranib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, improved clinical outcomes for patients with platinum-sensitive relapsed ovarian cancer when it was used with chemotherapy and was continued as maintenance therapy. This study describes health-related quality of life (QOL) during the first year of treatment.Methods: Four hundred fifty-six women were randomly allocated to receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib administered concurrently and continued as maintenance. Patients completed QOL questionnaires until disease progression every 3 weeks during chemotherapy and then every 6 weeks to 1 year. Patients alive with disease progression completed a QOL form 1 year after randomization. The primary QOL endpoint was the global score from the Quality of Life Questionnaire Core 30 (of the European Organization for Research and Treatment of Cancer) at 1 year, with the standard chemotherapy group compared with the concurrent-maintenance cediranib group.Results: The rate of questionnaire compliance was 90% at the baseline and 76% at 1 year and was similar across the 3 groups. The mean global QOL score at 1 year was 62.6 points for the standard chemotherapy group and 68.7 points for the concurrent-maintenance group (+4.5; 95% confidence interval, -2.0 to 11.0; P = .18). Sensitivity analyses suggested that this finding was robust to the effect of missing data, and the improvement became statistically significant after adjustments for self-reported diarrhea.Conclusions: The 6th study by the International Collaboration in Ovarian Neoplasm (ICON6) showed a significant improvement in progression-free survival with cediranib as concurrent and maintenance therapy. No QOL detriment with cediranib was found 1 year after treatment was commenced. The maintenance of QOL along with prolonged cancer control suggests that cediranib has a valuable role in the treatment of relapsed ovarian cancer. Cancer 2017;123:2752-61. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. [ABSTRACT FROM AUTHOR]

ABSTRACT Background As many delirium manifestations (e.g., hallucinations or fears) are linked to patients' experiences and personality traits, it is suggested that interventions should be tailored to optimize its management. The inclusion of family members, as part of an intervention, has recently emerged as a solution to developing individualised patient care, but has never been assessed in post-cardiac surgery intensive care unit where almost half of patients will present with delirium. Aims To assess the feasibility, acceptability and preliminary efficacy of an nursing intervention involving family caregivers ( FC) in delirium management following cardiac surgery. Design A randomized pilot study. Methods A total of 30 patient/ FC dyads were recruited and randomized to usual care ( n = 14) or intervention ( n = 16). The intervention was based on the Human Caring Theory, a mentoring model, and sources informing self-efficacy. It comprised seven planned encounters spread over 3 days between an intervention nurse and the FC, each including a 30-min visit at the patient's bedside. During this bedside visit, the FC used delirium management strategies, e.g. reorient the person with delirium. The primary indicator of acceptability was to obtain consent from 75% of approached FCs. The preliminary effect of the intervention on patient outcomes was assessed on (1) delirium severity using the Delirium Index, (2) occurrence of complications, such as falls, (3) length of postoperative hospital stay and (4) psycho-functional recovery using the Sickness Impact Profile. The preliminary effect on FC outcomes was assessed on FC anxiety and self-efficacy. Data were analysed using descriptive statistics, ANCOVAs and logistic regressions. Results The primary indicator of obtaining consent from FC was achieved (77%). Of the 14 dyads, thirteen (93%) dyads received all seven encounters planned in the experimental intervention. Intervention group patients presented better psycho-functional recovery scores when compared with control group patients ( p = 0·01). Mean delirium severity scores showed similar trajectories on days 1, 2 and 3 in both groups. Conclusion The mentoring intervention was acceptable and feasible and shows promising results in improving patients and FC outcomes. Relevance to clinical practice Nurses should involve, if willing, FC to participate in activities that optimise patient well-being FC to use recognized delirium management strategies like reorientation and reassurance. [ABSTRACT FROM AUTHOR]

ABSTRACT Background In intensive care units ( ICUs), patients cannot sleep well. Aromatherapy is used for depression, anxiety, relaxation and disorders related with sleep and stress. Aim This study aimed to investigate the effect of lavender essential oil on the sleep quality and anxiety level of patients in coronary ICU. Participants A total of 60 patients in coronary ICU participated in this study. Design A randomized controlled study was conducted with 60 patients in a province located in the southeast of Turkey. Methods After informing the patients in both groups about the study, they were administered a questionnaire, Pittsburgh Sleep Quality Index ( PSQI) and the Beck Anxiety Inventory ( BAI) scale. The patients in the intervention group were given 2% lavender essential oil via inhalation for 15 days after which they were administered the same scales again to evaluate the sleep quality and anxiety. As for the control group, they were administered the same scales again after 15 days without the inhalation of lavender essential oil. Results Comparison of the PSQI and BAI scores of the patients in the control and intervention groups before and after the intervention showed statistically significant differences in the change in favour of the intervention group ( p < 0·05). Conclusion Lavender essential oil increased quality of sleep and reduced level of anxiety in patients with coronary artery disease. Relevance to clinical practice As a non-invasive, cheap, easily applicable, cost-effective, independent nursing intervention and appropriate for cardiac patients, lavender essential oil could be applied in ICUs. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Our aim was to evaluate the effectiveness of a Post-it® note to increase response rates and shorten response times to a 4-month postal follow-up questionnaire sent to participants taking part in the Collaborative Care in Screen-Positive Elders (CASPER) trials. Method Our trial was a two-arm randomized controlled trial comparing response rates to questionnaires with a printed Post-it® note (intervention) and without (control), nested in multi centred randomized controlled trials of older people with varying levels of depressive symptoms; the CASPER+ and CASPER Self Help for those At Risk of Depression (SHARD) trials. A total of 611 participants were eligible and randomized. The primary outcome was response rates, secondary outcomes were time to response and need for a reminder. Results Of 297 participants, 266 (89.6%) returned their 4-month questionnaire in the post-it note arm, compared with 282 of 314 participants (89.8%) in the control arm (OR = 0.97, 95% CI: 0.57, 1.65, P = 0.913). There were no statistically significant differences in time to respond or the need to be sent a reminder. Patients with a major depressive episode were more likely to return questionnaires with post-it notes ( P of interaction = .019). Conclusion There was no significant difference in response rates, time to response, or the need for a reminder between the intervention and control at 4-month follow up for older people with depressive symptoms. However, there was a significant interaction between the Post-it® note group and level of depression. [ABSTRACT FROM AUTHOR]

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

Background Relapse is common in alcohol-dependent individuals and can be triggered by alcohol-related cues in the environment. It has been suggested that these individuals develop cognitive biases, in which cues automatically capture attention and elicit an approach action tendency that promotes alcohol seeking. The study aim was to examine whether cognitive bias modification ( CBM) training targeting approach bias could be delivered during residential alcohol detoxification and improve treatment outcomes. Methods Using a 2-group parallel-block (ratio 1:1) randomized controlled trial with allocation concealed to the outcome assessor, 83 alcohol-dependent inpatients received either 4 sessions of CBM training where participants were implicitly trained to make avoidance movements in response to pictures of alcoholic beverages and approach movements in response to pictures of nonalcoholic beverages, or 4 sessions of sham training (controls) delivered over 4 consecutive days during the 7-day detoxification program. The primary outcome measure was continuous abstinence at 2 weeks postdischarge. Secondary outcomes included time to relapse, frequency and quantity of alcohol consumption, and craving. Outcomes were assessed in a telephonic follow-up interview. Results Seventy-one (85%) participants were successfully followed up, of whom 61 completed all 4 training sessions. With an intention-to-treat approach, there was a trend for higher abstinence rates in the CBM group relative to controls (69 vs. 47%, p = 0.07); however, a per-protocol analysis revealed significantly higher abstinence rates among participants completing 4 sessions of CBM relative to controls (75 vs. 45%, p = 0.02). Craving score, time to relapse, mean drinking days, and mean standard drinks per drinking day did not differ significantly between the groups. Conclusions This is the first trial demonstrating the feasibility of CBM delivered during alcohol detoxification and supports earlier research suggesting it may be a useful, low-cost adjunctive treatment to improve treatment outcomes for alcohol-dependent patients. [ABSTRACT FROM AUTHOR]

The RELAX trial studied the efficacy of intra‐detrusor onabotulinum toxin A (onaBoNTA) for the treatment of detrusor overactivity (DO) in women. Our objectives in this study were to explore patients' experience and understanding of taking part in a randomised controlled trial (RCT) and their experience of the treatment itself. In addition we explored how patients felt about their bladder problem prior to treatment, conservative management strategies they had been offered, and anti‐muscarinic treatment. Purposive sampling was used to interview patients who had successful and unsuccessful outcomes. Interviewers were blinded to this sampling. Semi‐structured telephone interviews were conducted with all recruited women. Analysis was using a grounded theory approach. Transcripts were analysed thematically based on a constant comparative method until the point of data saturation, that is no new themes were identified. Fifteen women in total were interviewed. There were eight global themes identified. These were: quality of life, conservative management, study awareness, reasons for participation, role of the media, the extension study, intervention and experience of a RCT. The impact of overactive bladder (OAB) symptoms was a strong theme leading to feelings of anxiety. All of the women interviewed perceived pelvic floor exercises as a short term plan. Compliance was sporadic and most discontinued because of lack of efficacy. All women had been counselled about the risk of voiding dysfunction after onaBoNTA treatment and women found the actual process of being taught clean intermittent self‐catheterisation by another woman difficult, Patients stated they felt embarrassed and traumatised by the experience. OnaBoNTA is an effective treatment for patients with DO whose disease burden is considerable. This work highlights the value of incorporating qualitative research methods into the design of RCTs particularly when dealing with surgical procedures. [ABSTRACT FROM AUTHOR]

Background: This study's aims were to determine the efficacy and tolerability of rasagiline, a selective monoamine oxidase inhibitor B, for PD patients with mild cognitive impairment.Methods: Patients on stable dopaminergic therapy were randomized to adjunct rasagiline 1 mg/day or placebo in this 24-week, double-blind, placebo-controlled, multisite study. The primary endpoint was mean change from baseline to week 24 on the Scales for Outcomes of Parkinson's Disease-Cognition total score. Key secondary measures included changes in cognition, activities of daily living, motor scores, and Clinical Global Impression of Change, as well as safety and tolerability measures.Results: Of the 170 patients randomized, 151 (88.2%) completed the study. Change in Scales for Outcomes of Parkinson's Disease-Cognition scores were not significantly different in the rasagiline and placebo groups (adjusted mean: 1.6 [standard error {SE} = 0.5] vs. 0.8 [SE = 0.5] points; LS means difference = 0.8; 95% confidence interval: -0.48, 2.05; P = 0.22). There were no between-group differences in change in the MoCA (p=0.84) or Penn Daily Activities Questionnaire (P = 0.48) scores or in the distribution of Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change modified for mild cognitive impairment (P = 0.1). Changes in motor (UPDRS part III; P = 0.02) and activities of daily living (UPDRS part II; P < 0.001) scores favored rasagiline. Rasagiline was well tolerated; the most common adverse events in both groups were falls and dizziness.Conclusions: Rasagiline treatment in PD patients with mild cognitive impairment was not associated with cognitive improvement. Rasagiline did not worsen cognition, improved motor symptoms and activities of daily living, and was well tolerated in elderly cognitively impaired patients. © 2016 International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]

The present study examines a more fine-grained analysis of anxiety-related and depression-related outcomes amongst a sample of treatment completers who were assigned to complicated grief treatment (CGT) ( n = 35) or interpersonal psychotherapy (IPT) ( n = 34) in a previously reported randomized controlled trial. We examined effects of antidepressant use and measures of anxiety and depression, focusing especially on guilt related to the death or deceased and grief-related avoidance in order to further understand the differential effectiveness of CGT and IPT amongst participants who received the full course of treatment. Analyses showed that CGT produced greater reductions in anxiety and depressive symptoms including negative thoughts about the future and grief-related avoidance. CGT's advantage over IPT in lowering depression was most pronounced amongst those not taking antidepressants. Our results further elucidate CGT effects and support the idea that CG and major depressive disorder are distinct conditions. Copyright © 2014 John Wiley & Sons, Ltd. Key Practitioner Message Targeted treatment for complicated grief (CG) produces benefits in associated mood and anxiety symptoms and CG symptoms., Amongst patients with CG, interpersonal psychotherapy seems relatively ineffective in ameliorating depressive symptoms., Grief-related depressive symptoms may not respond to standard treatments unless CG symptoms are also addressed., Reducing grief-related symptoms, such as anxieties about the future, guilt related to the death or deceased and avoidance of reminders of the loss may be important aspects in reducing CG. [ABSTRACT FROM AUTHOR]

ABSTRACT Background Endotracheal suctioning has been identified as a painful procedure for critically ill patients. Aim To determine the effect of music therapy on pain intensity, sedation level and physiological parameters during endotracheal suctioning of mechanically ventilated patients in cardiovascular surgery intensive care unit (ICU). Design Experimental survey. Methods The study was conducted between May 2010 and June 2013 in Ordu Medical Park Hospital Cardiovascular Surgery Intensive Care Unit. The study sample consisted of 66 patients (33 experimental and 33 control) who complied with the criteria of inclusion for the study. Data was collected using the 'Patient Information Form', 'Critical-Care Pain Observation Tool', 'Ramsay Sedation Scale' and 'Form of Physiological Parameters'. Results The mean scores of the Ramsay Sedation Scale during endotracheal aspiration were respectively 1·88 and 1·55 in the experimental and control group and the difference between the groups was statistically significant ( p = 0·003). The mean score of Critical-Care Pain Observation Tool during endotracheal suctioning in the experimental group was found to be lower statistically than those of the control group ( p < 0·001). There were no significant differences before, during and 20 min after suctioning between the two groups with regard to systolic blood pressure, diastolic blood pressure, heart rate and oxygen saturation ( p > 0·05). Conclusions The results of this study implies that music therapy can be effective practice for nurses attempting to reduce patients' pain and control sedation level in patients on mechanical ventilators during endotracheal suctioning. Relevance to clinical practice It is recommended that music therapy should be added to the routine nursing care for mechanically ventilated patients. [ABSTRACT FROM AUTHOR]

Although cognitive interventions for obsessive-compulsive disorder (OCD) have been tested in randomized trials, there are few trials that have tested the specific mechanisms of cognitive interventions, i.e. how they achieve their effects. In this study, we aimed to investigate the mediating effects of a short cognitive intervention in the treatment of OCD and used data from a recently conducted randomized controlled trial where 101 participants were allocated to either Internet-based CBT (ICBT) or to a control condition. Obsessive beliefs were measured at pre-treatment, at the time they had received the cognitive intervention, and also at post-treatment. Weekly OCD symptoms were measured throughout the 10 weeks of treatment. We hypothesized that (1) the ICBT group would have greater reductions in obsessive beliefs (controlling for change in OCD symptoms) after completing the cognitive intervention, and that (2) this reduction would, in turn, predict greater OCD symptom reduction throughout the rest of the treatment period. Contrary to our expectations, the longitudinal mediation analysis indicated that (1) being randomized to ICBT actually increased the degree of obsessive beliefs after receiving the cognitive intervention at weeks 1-3, and (2) increase in obsessive beliefs predicted better outcome later in treatment. However, when repeating the analysis using cross-sectional data at post-treatment, the results were in line with the initial hypotheses. Results were replicated when the control condition received ICBT. We conclude that, although obsessive beliefs were significantly reduced at post-treatment for the ICBT group, early increase rather than decrease in obsessive beliefs predicted favourable outcome. [ABSTRACT FROM AUTHOR]

Aims To assess the relations of menthol cigarette use with measures of cessation success in a large comparative effectiveness trial ( CET). Design Participants were randomized to one of six medication treatment conditions in a randomized double-blind, placebo-controlled clinical trial. All participants received six individual counseling sessions. Setting Community-based smokers in two communities in Wisconsin, USA. Participants A total of 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. The analysis sample comprised 1439 participants: 814 white non-menthol smokers, 439 white menthol smokers and 186 African American ( AA) menthol smokers. There were too few AA non-menthol smokers ( n = 16) to be included in the analyses. Interventions Nicotine lozenge, nicotine patch, bupropion sustained release, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge and placebo. Measurements Biochemically confirmed 7-day point-prevalence abstinence assessed at 4, 8 and 26 weeks post-quit. Findings In longitudinal abstinence analyses (generalized estimating equations) controlling for cessation treatment, menthol smoking was associated with reduced likelihood of smoking cessation success relative to non-menthol smoking [model-based estimates of abstinence = 31 versus 38%, respectively; odds ratio ( OR) = 0.71, 95% confidence interval ( CI) = 0.59, 0.86]. In addition, among menthol smokers, AA women were at especially high risk of cessation failure relative to white women (estimated abstinence = 17 versus 35%, respectively; OR = 2.63, 95% CI = 1.75, 3.96; estimated abstinence rates for AA males and white males were both 30%, OR = 1.06, 95% CI = 0.60, 1.66). Conclusion In the United States, smoking menthol cigarettes appears to be associated with reduced cessation success compared with non-menthol smoking, especially in African American females. [ABSTRACT FROM AUTHOR]

Background A substantial minority of adolescents suffer from depression and it is associated with increased risk of suicide, social and educational impairment, and mental health problems in adulthood. A recently conducted randomized controlled trial in England evaluated the effectiveness of a manualized universally delivered age-appropriate CBT programme in school classrooms. The cost-effectiveness of the programme for preventing low mood and depression for all participants from a health and social care sector perspective needs to be determined. Methods A trial-based cost-effectiveness analysis based on a cluster-randomized controlled trial (trial registration - ISRCTN 19083628) comparing classroom-based CBT with usual school provision of Personal Social and Health Education. Per-student cost of intervention was estimated from programme records. The study was undertaken in eight mixed-sex UK secondary schools, and included 3,357 school children aged 12 to 16 years (in the two trial arms evaluated in the cost-effectiveness analysis). The main outcome measures were individual self-reported data on care costs, Quality-Adjusted Life-Years ( QALYs, based on the EQ-5D health-related quality-of-life instrument) and symptoms of depression (Short Mood and Feelings Questionnaire) at baseline, 6 and 12 months. Results Although there was lower quality-adjusted life-years over 12 months (−.05 QALYs per person, 95% confidence interval −.09 to −.005, p = .03) with CBT, this is a 'clinically' negligible difference, which was not found in the complete case analyses. There was little evidence of any between-arm differences in SMFQ scores (0.19, 95% CI −0.57 to 0.95, p = .62), or costs (£142, 95% CI −£132 to £415, p = .31) per person for CBT versus usual school provision. Conclusions Our analysis suggests that the universal provision of classroom-based CBT is unlikely to be either more effective or less costly than usual school provision. [ABSTRACT FROM AUTHOR]

Aims To examine the efficacy of a brief intervention delivered by a therapist ( TBI) or a computer ( CBI) in preventing cannabis use among adolescents in urban primary care clinics. Design A randomized controlled trial comparing: CBI and TBI versus control. Setting Urban primary care clinics in the United States. Participants Research staff recruited 714 adolescents (aged 12-18 years) who reported no life-time cannabis use on a screening survey for this study, which included a baseline survey, randomization (stratified by gender and grade) to conditions (control; CBI; TBI) and 3-, 6- and 12-month assessments. Measurements Using an intent-to-treat approach, primary outcomes were cannabis use (any, frequency); secondary outcomes included frequency of other drug use, severity of alcohol use and frequency of delinquency (among 85% completing follow-ups). Findings Compared with controls, CBI participants had significantly lower rates of any cannabis use over 12 months (24.16%, 16.82%, respectively, P < 0.05), frequency of cannabis use at 3 and 6 months ( P < 0.05) and other drug use at 3 months ( P < 0.01). Compared with controls, TBI participants did not differ in cannabis use or frequency, but had significantly less other drug use at 3 months ( P < 0.05), alcohol use at 6 months ( P < 0.01) and delinquency at 3 months ( P < 0.01). Conclusions Among adolescents in urban primary care in the United States, a computer brief intervention appeared to prevent and reduce cannabis use. Both computer and therapist delivered brief interventions appeared to have small effects in reducing other risk behaviors, but these dissipated over time. [ABSTRACT FROM AUTHOR]

Background: Submassive pulmonary embolism (PE) has a low mortality rate but can degrade functional capacity. Objective: The present study aims to provide rationale, methodology, and initial findings of a multicentre, randomised trial of fibrinolysis for PE that used a composite end-point, including quality of life measures. Methods: This investigator-initiated study was funded by a contract between a corporate partner and the investigator's hospital (the prime site). The investigator was the Food and Drug Administration (FDA) sponsor. The prime site subcontracted, indemnified, and trained consortia members. Consenting, normotensive patients with PE and right ventricular strain (by echocardiography or biomarkers) received low-molecular-weight heparin and random assignment to a single bolus of tenecteplase or placebo in double-blinded fashion. The outcomes were: (i) in-hospital rate of intubation, vasopressor support, and major haemorrhage, or (ii) at 90 days, death, recurrent PE, or composite that defined poor quality of life (echocardiography, 6 min walk test and surveys). The planned sample size was n = 200. Results: Eight sites enrolled 87 patients over 5 years. The ratio of patients screened for each enrolled was 7.4 to 1, equating to 11 h screening time per patient enrolled. Primary barrier to enrolment was the cost of screening. Two patients died (2.5%, 95%CI [0-8%]), one developed shock, but 18 (22%, 95%CI: [13-30%]) had a poor quality of life. Conclusions: An investigator-initiated, FDA-regulated, multicentre trial of fibrinolysis for submassive PE was conducted, but was limited by screening costs and a low mortality rate. Quality of life measurements might represent a more important patient-centred end-point. [ABSTRACT FROM AUTHOR]

Background It has been increasingly recognized that subthreshold depression is associated with considerable personal, social and economic costs. However, there is no accepted definition or clear-cut treatment for subthreshold depression. Cognitive bibliotherapy is a promising approach, but further research is necessary in order to assess its clinical efficacy and key mechanisms of change. Aim This study aimed to investigate the efficacy of bibliotherapy for subthreshold depression and test whether maladaptive cognitions mediate the effects of bibliotherapy on depressive symptoms. Method A total of 96 young adults with subthreshold depression were randomized in one of the following treatment conditions: immediate treatment, delayed treatment, placebo and no treatment. The main outcome was represented by depressive symptoms assessed before, during and immediately after the treatment, as well as at 3-month follow-up. Automatic thoughts, dysfunctional attitudes and irrational beliefs were also assessed throughout the study, and we investigated their involvement as mediators of bibliotherapy effects on depressive symptoms. Results The results indicated that cognitive bibliotherapy resulted in statistically and clinically significant changes both in depressive symptoms and cognitions, which were maintained at follow-up. In contrast, placebo was only associated with a temporary decrease in depressive symptoms, without significant cognitive changes. No changes in symptoms or cognitions were found in the delayed treatment and no treatment groups. We also found that automatic thoughts significantly mediated the effect of bibliotherapy on depressive symptoms. Conclusion This study provided compelling evidence for the efficacy of cognitive bibliotherapy in subthreshold depression and showed that changes in automatic thoughts mediated the effect of bibliotherapy on depressive symptoms. Copyright © 2012 John Wiley & Sons, Ltd. Key Practitioner Message Cognitive bibliotherapy is an effective treatment of subthreshold depression., Changing automatic thoughts is important, as they mediate the bibliotherapy effect on depressive symptoms., Cognitive bibliotherapy is a potential alternative or adjunct to psychotherapy for mildly depressed adults. [ABSTRACT FROM AUTHOR]

Background: Attention deficit hyperactivity disorder is increased in children with intellectual disability. Previous research has suggested stimulants are less effective than in typically developing children but no studies have titrated medication for individual optimal dosing or tested the effects for longer than 4 weeks. Method: One hundred and twenty two drug-free children aged 7-15 with hyperkinetic disorder and IQ 30-69 were recruited to a double-blind, placebo-controlled trial that randomized participants using minimization by probability, stratified by referral source and IQ level in a one to one ratio. Methylphenidate was compared with placebo. Dose titration comprised at least 1 week each of low (0.5 mg/kg/day), medium (1.0 mg/kg/day) and high dose (1.5 mg/kg/day). Parent and teacher Attention deficit hyperactivity disorder (ADHD) index of the Conners Rating Scale-Short Version at 16 weeks provided the primary outcome measures. Clinical response was determined with the Clinical Global Impressions scale (CGI-I). Adverse effects were evaluated by a parent-rated questionnaire, weight, pulse and blood pressure. Analyses were by intention to treat. Trial registration: ISRCTN 68384912. Results: Methylphenidate was superior to placebo with effect sizes of 0.39 [95% confidence intervals (CIs) 0.09, 0.70] and 0.52 (95% CIs 0.23, 0.82) for the parent and teacher Conners ADHD index. Four (7%) children on placebo versus 24 (40%) of those on methylphenidate were judged improved or much improved on the CGI. IQ and autistic symptoms did not affect treatment efficacy. Active medication was associated with sleep difficulty, loss of appetite and weight loss but there were no significant differences in pulse or blood pressure. Conclusions: Optimal dosing of methylphenidate is practical and effective in some children with hyperkinetic disorder and intellectual disability. Adverse effects typical of methylphenidate were seen and medication use may require close monitoring in this vulnerable group. [ABSTRACT FROM AUTHOR]

International Journal of Paediatric Dentistry 2012; 22: 180-190 Objective. Xylitol studies suggest caries reductions in the order of 50%. Based on animal/microbial studies, erythritol potentially has caries-preventive properties. However, clinical studies are required to confirm this.The aim of the study was to investigate the additional caries-preventive effect of xylitol/maltitol and erythritol/maltitol lozenges delivered at school, relative to controls receiving comprehensive prevention, in a low-caries prevalence population. Methods. A 4-year, cluster-randomized, double-blinded clinical trial. Five hundred and seventy-nine 10-year-old consenting subjects from 21 schools were randomly assigned to one of five groups. Four groups used the lozenges on school days, in three teacher-supervised sessions daily, over 1 or 2 years. The daily amount was 4.7 g/4.6 g for xylitol/maltitol and 4.5 g/4.2 g for erythritol/maltitol. The groups received free examinations and care in the public health centre. Four hundred and ninety-six children were analysed. The main outcome measure was dentin caries increment based on a clinical examination at 4 years since the start. The groups were compared in relation to the increment using hierarchical logistic regression to adjust for potential clustering. Results. Use of xylitol/maltitol or erythritol/maltitol lozenges did not result in caries reduction. A strong relationship between baseline caries prevalence and the 4-year increment was observed (OR = 7.38; 95% CI: 3.78-14.41). Conclusions. The results suggest that in relatively low-caries conditions the school-based use of xylitol/maltitol or erythritol/maltitol lozenges would not have additional caries-preventive effect when compared with comprehensive prevention. [ABSTRACT FROM AUTHOR]

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

We investigated whether providing participants in an exercise programme with regular feedback on their exercise progress affected their adherence to the programme regimen. We conducted a randomized controlled trial. Adult men and women with borderline hypertension and a body mass index ≥ 25.0 were randomized to two intervention groups (groups A and B) and one control group (group C) and were prescribed regular aerobic exercise. During the 12-week study period, group A was provided with both feedback information on their exercise progress and a health letter, while group B was provided with the health letter only. The main outcome measure was exercise performance, per cent achievement of target exercise level (%) defined as the number of weeks during which the exercise target was reached divided by the number of weeks in the programme. Results were compared using the Kruskal-Wallis test. A total of 105 study subjects were randomized into three groups (A, n = 37; B, n = 37 and C, n = 31). Per cent achievement of target exercise level during the 12-week period was highest in group A (26.5%), followed by groups B (22.9%) and C (17.4%) ( P = 0.36). Subjects who received regular feedback during the exercise programme tended to have higher exercise performance. In improving adherence to exercise intervention, the provision of regular feedback to participants in an exercise programme may be an effective intervention. [ABSTRACT FROM AUTHOR]

This study examines 24-months post-baseline outcomes for thirty-five Swedish antisocial youths who received either treatment in multidimensional treatment foster care (MTFC) or treatment as usual (TAU). MTFC is a community-based treatment programme that has been successful in treating chronic juvenile offenders in the USA. This study is the first randomized control study outside the USA. The youth treated in the MTFC programme consistently showed some statistically significant positive treatment effects compared to the youth exposed to TAU. The results suggest that MTFC might be an effective method in treating youth with severe behaviour problems in a Swedish context. The authors conclude that the programme ought to be of great interest for Swedish social services as an alternative to traditional care. [ABSTRACT FROM AUTHOR]

This study evaluated for 152 patients the relationship between their attitudes toward treatment and session attendance in pharmacotherapy research trials aimed at treating alcohol dependence. The study included a new, 50-item, patient-administered measure of attitudes, Treatment Research Experiences and Attitudes Task (TREAT), which is comprised of ten items from each of five attitudinal dimensions typically associated with treatment adherence: treatment setting, taking medication, social support, medical professional, and intrinsic patient factors. Patients attending 80% or more clinical sessions scored higher, i.e., were more favorable on four of five of attitudinal dimensions. Thus, patient attitudes toward treatment may be useful in identifying areas that limit or improve treatment attendance. [ABSTRACT FROM AUTHOR]

The authors comment on a study comparing Mindfulness Based Interventions (MBIs) with Cognitive Behavioural Therapy (CBT) for the patients with depression, anxiety and stress disorders. Topics discussed include cost effectiveness of mindfulness based group, maintenance of the long term effect of the treatment after intervention and increasing prevalence of depression and anxiety.