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Objective: The DAISIES trial, comparing inpatient and stepped‐care day patient treatment for adults with severe anorexia nervosa was prematurely terminated in March 2022 due to poor recruitment. This qualitative study seeks to understand the difficulties faced during the trial by investigating stakeholders' views on and experiences of its implementation. Method: Semi‐structured interview and focus group transcripts, and trial management and oversight group meeting minutes from May 2020‐June 2022 were analysed using thematic analysis. Participants were 47 clinicians and co‐investigators involved with the DAISIES trial. The Non‐Adoption, Abandonment, Scale‐up, Spread, and Sustainability (NASSS) framework was applied to the interpretive themes to classify barriers and facilitators to implementation. Results: Five themes were identified: incompatible participation interests; changing standard practice; concerns around clinical management; systemic capacity and capability issues; and Covid‐19 disrupting implementation. Applying the NASSS framework indicated the greatest implementation challenges to arise with the adopters (e.g. patients, clinicians), the organisational systems (e.g. service capacity), and the wider socio‐political context (e.g. Covid‐19 closing services). Conclusions: Our findings emphasise the top‐down impact of systemic‐level research implementation challenges. The impact of the Covid‐19 pandemic accentuated pre‐existing organisational barriers to trial implementation within intensive eating disorder services, further limiting the capacity for research. Highlights: The paper highlights the particular challenges to research implementation that arise within an NHS intensive service context.Applying an implementation science framework to the interpretive themes indicated that challenges to implementation spanned the individual to the systemic level, with the latter posing greater barriers and impacting implementation success in other areas.The results suggest that future research into intensive treatment needs to better accommodate patient preferences and emphasise clinician‐researcher relationships and the alignment of clinical and research teams. [ABSTRACT FROM AUTHOR]

Background: Almost no research has been published reporting on evaluations of the effectiveness of psychological interventions for people with severe to profound intellectual disabilities and depression. This paper describes the development and initial feasibility testing of an adapted Behavioural Activation therapy (BeatIt2) for this population. Method: Phase 1 of the study examined participant recruitment and willingness to be randomised in the context of a planned Randomised Controlled Trial (RCT). Phase 2 examined the feasibility of delivering the intervention. Results: Twenty adults with a severe or profound intellectual disability and clinically significant depression were recruited to Phase 1 of the study. In Phase 2, there was 100% participant retention for those recruited to the study at 6‐month follow‐up. The BeatIt2 therapy was reported to be acceptable for participants. Conclusion: COVID disruption meant that it was not possible to complete the planned feasibility RCT. The positive findings suggest that additional evaluation of BeatIt2 is warranted. [ABSTRACT FROM AUTHOR]

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

Good nutrition in the early years of life is vitally important for a child's development, growth and health. Children's diets in the United Kingdom are known to be poor, particularly among socially disadvantaged groups, and there is a need for timely and appropriate interventions that support parents to improve the diets of young children. The Medical Research Council has highlighted the importance of conducting developmental and exploratory research prior to undertaking full-scale trials to evaluate complex interventions, but have provided very limited detailed guidance on the conduct of these initial phases of research. This paper describes the initial developmental stage and the conduct of an exploratory randomised controlled trial undertaken to determine the feasibility and acceptability of a family-centred early years' nutrition intervention. Choosing Healthy Eating when Really Young ( CHERRY) is a programme for families with children aged 18 months to 5 years, delivered in children's centres in one urban ( Islington) and one rural ( Cornwall) location in the United Kingdom. In the development stage, a mixed-methods approach was used to investigate the nature of the problem and options for support. A detailed review of the evidence informed the theoretical basis of the study and the creation of a logic model. In the feasibility and pilot testing stage of the exploratory trial, 16 children's centres, with a sample of 394 families were recruited onto the study. We hope that the methodology, which we present in this paper, will inform and assist other researchers in conducting community-based, exploratory nutrition research in early years settings. [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: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable treatment delivery can be achieved. Aims: To present the rationale, structure and content of an intensive manualized intervention as implemented within an RCT for children with complex pragmatic and social communication needs; to investigate factors associated with implementation in a mainstream school environment; and to determine treatment fidelity. Methods & Procedures: The manualized SCIP intervention, including procedures for developing individualized treatment plans, was developed and then implemented within an RCT with 57 school-aged children with complex pragmatic communication needs (CwPLI). The paper describes the delivery protocol, staffing requirements, and content and structure of the intervention. A mapping procedure for individualization of intervention and the implemented components of intervention are presented. The findings from a school-therapy alliance checklist for recording factors affecting implementation in a school context are also reported. Treatment fidelity was carried out using measures of delivered versus planned treatment content and quality of therapy. Outcomes & Results: The manual was effective at detailing intervention procedures and allowing for development of individualized treatment plans whilst maintaining satisfactory treatment fidelity. Treatment planning and delivery required continuous specialist speech and language therapist input with assistants needing substantive training and supervision. Key components of intervention for CwPLI were therapies aimed at improving conversation skills, narrative construction, comprehension monitoring, understanding of social cues and metapragmatic awareness. The school-therapy alliance checklist indicated high rates of therapist-education staff and therapist-parent liaison. Parents were nearly always involved in treatment planning though only half-attended therapy sessions. Learning support provision in schools for participating children was highly variable. Conclusions & Implications: Predetermining theoretical background, structure, and content in a treatment manual contributed towards the quality and reliability of intervention within the context of an RCT. The implementation of SCIP intervention in a broader clinical context is discussed with reference to staff expertise, the therapeutic process and the essential ingredients of social communication intervention. [ABSTRACT FROM AUTHOR]

Aims: Assess effectiveness of a hybrid intervention targeting physical activity in women with prior gestational diabetes. Methods: Randomised controlled trial with parallel arms. 293 women (35.1 ± 5.1 years; 40% ethnic minority) recruited from two hospitals and randomised to routine care or hybrid lifestyle intervention comprising two group sessions and access to a mobile web app. Primary outcome was a change in objectively measured physical activity at 12 months. Secondary outcomes included self‐efficacy for exercise, quality of life and anxiety and depression. Linear regression compared outcome measures between groups. Results: 83% of intervention participants attended at least one group session, of who 66% registered to use the app. There was a non‐significant increase in physical activity at 12 months (between‐group difference of 0.95 mg [95% CI: −0.46 to 2.37]), equivalent to approximately 500 steps per day. Intervention participants reported higher self‐efficacy for exercise (0.54, 95% CI: 0.05 to 1.102; p = 0.029), lower anxiety (−0.91, 95% CI: −1.74 to −0.09; p = 0.031), and higher quality of life (0.05, 95% CI: 0.004 to 0.09; p = 0.032), compared to controls. Conclusions: The intervention improved confidence in exercise and quality of life. Further research is needed to improve participant engagement with physical activity interventions in multi‐ethnic populations with a history of gestational diabetes. [ABSTRACT FROM AUTHOR]

Background: The SlowMo study demonstrated the effects of SlowMo, an eight‐session digitally supported reasoning intervention, on paranoia in a large‐scale randomized‐controlled trial with 362 participants with schizophrenia‐spectrum psychosis. Aim: The current evaluation aimed to investigate the impact of Patient and Public Involvement (PPI) in the SlowMo study. Method: PPI members were six women and three men from Sussex, Oxford and London with experience of using mental health services for psychosis. They received training and met at least 3‐monthly throughout the project. The impact of PPI was captured quantitatively and qualitatively through (i) a PPI log of recommendations and implementation; (ii) written subjective experiences of PPI members; (iii) meeting minutes; and (iv) outputs produced. Results: The PPI log revealed 107 recommendations arising from PPI meetings, of which 87 (81%) were implemented. Implementation was greater for recruitment‐, data collection‐ and organization‐related actions than for dissemination and emergent innovations. Qualitative feedback revealed impacts on study recruitment, data collection, PPI participants' confidence, knowledge, career aspirations and society more widely. Outputs produced included a film about psychosis that aired on BBC primetime television, novel webpages and journal articles. Barriers to PPI impact included geography, travel, funding, co‐ordination and well‐being. Discussion: A future challenge for PPI impact will be the extent to which peer innovation (innovative PPI‐led ideas) can be supported within research study delivery. Patient and Public Contribution: Planned Patient and Public Contribution in SlowMo comprised consultation and collaboration in (i) design, (ii) recruitment, (iii) qualitative interviews and analysis of service users' experiences of SlowMo therapy and (iv) dissemination. [ABSTRACT FROM AUTHOR]

Objective: To compare electrodiathermy with helium thermal coagulation in laparoscopic treatment of mild-to-moderate endometriosis.Design: Parallel-group randomised controlled trial.Setting: A UK endometriosis centre.Population: Non-pregnant women aged 16-50 years with a clinical diagnosis of mild-to-moderate endometriosis.Methods: If mild or moderate endometriosis was confirmed at laparoscopy, women were randomised to laparoscopic treatment with electrodiathermy or helium thermal coagulator.Main Outcome Measures: Cyclical pain and dyspareunia (rated on a 100-mm visual analogue scale, VAS), quality of life at baseline and at 6, 12 and 36 weeks following surgery, operative blood loss and surgical complications.Results: A total of 192 women were randomised. Of these, 155 (81%) completed the primary outcome point at 12 weeks. In an intention-to-treat analysis, VAS scores for cyclical pain were significantly lower in the electrodiathermy group compared with the helium group at 12 weeks (mean difference, 9.43 mm; 95% CI 0.46, 18.40 mm; P = 0.039) and across all time points (mean difference, 10.13 mm; 95% CI 3.48, 16.78 mm; P = 0.003). A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference, 11.66 mm; 95% CI 1.39, 21.93 mm; P = 0.026). These effects were smaller than the proposed minimum important difference of 18.00 mm, however. Differences in some aspects of quality of life favoured electrodiathermy. There was no significant difference in operative blood loss (fold-change with helium as reference, 1.43; 95% CI 0.96, 2.15; P = 0.081).Conclusions: Although electrodiathermy was statistically superior to helium ablation in reducing cyclical pain and dyspareunia, these effects may be too small to be clinically significant.Tweetable Abstract: Helium coagulation is not superior to electrodiathermy in laparoscopic treatment of mild-to-moderate endometriosis. [ABSTRACT FROM AUTHOR]

Objective: Troublesome hot flushes and night sweats (HFNS) are experienced by many women after treatment for breast cancer, impacting significantly on sleep and quality of life. Cognitive behavioural therapy (CBT) is known to be effective for the alleviation of HFNS. However, it is not known if it can effectively be delivered by specialist nurses. We investigated whether group CBT, delivered by breast care nurses (BCNs), can reduce the impact of HFNS.Methods: We recruited women with primary breast cancer following primary treatment with seven or more HFNS/week (including 4/10 or above on the HFNS problem rating scale), from six UK hospitals to an open, randomised, phase 3 effectiveness trial. Participants were randomised to Group CBT or usual care (UC). The primary endpoint was HFNS problem rating at 26 weeks after randomisation. Secondary outcomes included sleep, depression, anxiety and quality of life.Results: Between 2017 and 2018, 130 participants were recruited (CBT:63, control:67). We found a 46% (6.9-3.7) reduction in the mean HFNS problem rating score from randomisation to 26 weeks in the CBT arm and a 15% (6.5-5.5) reduction in the UC arm (adjusted mean difference -1.96, CI -3.68 to -0.23, P = .039). Secondary outcomes, including frequency of HFNS, sleep, anxiety and depression all improved significantly.Conclusion: Our results suggest that specialist nurses can be trained to deliver CBT effectively to alleviate troublesome menopausal hot flushes in women following breast cancer in the NHS setting. [ABSTRACT FROM AUTHOR]

Objective: To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits.Design: Randomised controlled trial.Setting: Thirty-three UK hospitals.Population: Women having surgery for recurrent prolapse.Methods: Women recruited using remote randomisation.Main Outcome Measures: Prolapse symptoms, condition-specific quality-of-life and serious adverse effects.Results: A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision.Conclusions: We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis.Tweetable Abstract: There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery. [ABSTRACT FROM AUTHOR]

Abstract: Background: Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post‐stroke pneumonia, which causes 30% of stroke‐related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post‐stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted posture, rather than direct physical rehabilitation of the swallowing function. Transcutaneous neuromuscular electrical stimulation (NMES) is a promising rehabilitation technology that can be used to stimulate swallowing; however, findings regarding efficacy have been conflicting. Aims: This pilot randomized controlled study involving three UK sites compared the efficacy of the Ampcare Effective Swallowing Protocol (ESP), combining NMES with swallow‐strengthening exercises, with usual care in order to clarify evidence on NMES in the treatment of dysphagia post‐stroke. A further objective was to pilot recruitment procedures and outcome measures in order to inform the design of a full‐scale trial. Methods & Procedures: Thirty patients were recruited and randomized into either (1) usual speech and language therapy dysphagia care; or (2) Ampcare ESP, receiving treatment 5 days/week for 4 weeks. Outcome measures included: the Functional Oral Intake Scale (FOIS), the Rosenbek Penetration‐Aspiration Scale (PAS) and patient‐reported outcomes (Swallow Related Quality of Life—SWAL‐QOL). Outcomes & Results: Thirty patients were recruited; 15 were randomized to the Ampcare ESP intervention arm and 15 to usual care. A greater proportion (75%, or 9/12) of patients receiving Ampcare ESP improved compared with 57% (or 8/14) of the usual‐care group. Patients receiving Ampcare ESP also made clinically meaningful change (a comparative benefit of 1.5 on the FOIS, and on the PAS: 1.35 for diet and 0.3 for fluids) compared with usual care. The intervention group also reported much better outcome satisfaction. Conclusions & Implications: The pilot demonstrated successful recruitment, treatment safety and tolerability and clinically meaningful outcome improvements, justifying progression to a fully powered study. It also showed clinically meaningful treatment trends for the Ampcare ESP intervention. [ABSTRACT FROM AUTHOR]

Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug-related death soon after release from prison. The NALoxone InVEstigation (N-ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone-on-release (NOR) to eligible prisoners in England. Design. Parallel-group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre-randomization, release due within 3 months and more than 6 months since previous N-ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single 'rescue' injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self-questionnaires (RPSQs: 207), NOR-carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70-74%]; 218 RPSQs were received; NOR-carriage (95% CI = 63-79%) and overdose presence (95% CI = 75-84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one-third of NOR administrations were to the ex-prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take-home emergency naloxone prior to prison release may be a life-saving interim measure to prevent heroin overdose deaths among ex-prisoners and the wider population. [ABSTRACT FROM AUTHOR]

Objectives To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomized controlled trial (RCT). Methods A methodological, two-arm, RCT was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomized for the embedded trial, using a 1:2 ratio (intervention : control) before being randomized for REFORM. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2-3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox proportional hazards model and incremental cost-effectiveness ratios. Results Of the 1436 intervention group participants, 73 (5.1%) were randomized into the REFORM trial compared with 126 (4.4%) of the 2878 control group participants. The associated relative risk (1.16) was not statistically significant [95% confidence interval (CI) 0.88-1.56]. Return rate was not significantly increased (relative risk 1.10, 95% CI 0.92-1.28) nor time to return decreased (hazard ratio: 1.11, 95% CI 0.93-1.33). Incremental cost-effectiveness ratios indicated the intervention may be cost-effective if the true estimate of effect was close to the upper bound of the associated 95% CI. Conclusion Pre-notification for potential trial participants demonstrated a small difference to randomization (0.7% difference) and return rates (1.1% difference) in favour of the intervention. Results should however be interpreted with caution as CIs for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended. [ABSTRACT FROM AUTHOR]

Aims To determine whether the provision of contingencymanagement using financial incentives to improve hepatitis B vaccine completion in people who inject drugs entering community treatment represents a cost-effective use of healthcare resources. Design A probabilistic cost-effectiveness analysis was conducted, using a decision-tree to estimate the short-term clinical and health-care cost impact of the vaccination strategies, followed by a Markov process to evaluate the long-term clinical consequences and costs associated with hepatitis B infection. Settings and participants Data on attendance to vaccination from a UK cluster randomized trial. Intervention Two contingency management options were examined in the trial: fixed versus escalating schedule financial incentives. Measurement Life-time health-care costs and quality-adjusted life years discounted at 3.5% annually; incremental cost-effectiveness ratios. Findings The resulting estimate for the incremental life-time health-care cost of the contingency management strategy versus usual care was £21.86 [95% confidence interval (CI) = -£12.20 to 39.86] per person offered the incentive. For 1000 people offered the incentive, the incremental reduction in numbers of hepatitis B infections avoided over their lifetime was estimated at 19 (95% CI = 8-30). The probabilistic incremental cost per quality adjusted life-year gained of the contingency management programmewas estimated to be £6738 (95% CI = £6297-7172),with an 89% probability of being considered cost-effective at a threshold of £20 000 per quality-adjusted life years gained (97.60% at £30 000). Conclusions Using financial incentives to increase hepatitis B vaccination completion in people who inject drugs could be a cost-effective use of health-care resources in the UK as long as the incidence remains above 1.2%. [ABSTRACT FROM AUTHOR]

Background In phenylketonuria ( PKU), little is known about the effect of bitter-tasting phenylalanine-free l-amino acid exposure on taste preference development. The present prospective study aimed to determine the flavour preferences of children with PKU versus healthy control children. Methods Thirty-five children with PKU and 35 age/gender-matched controls, aged 4-13 years, tasted 10 blinded puree foods in random order. They were rated using a seven-point pictorial hedonic scale (super yummy to super yucky) and ranked in preferential order. Caregivers completed a neophobia and food frequency questionnaire on behalf of their children. Results Both PKU and control groups rated sweet foods higher than savoury, bitter and sour foods. However, control children ranked fruits as a group higher than PKU children (mean 3.7 versus 4.6; P = 0.03), whereas PKU children ranked vegetables as a group higher than controls (mean 5.6 versus 6.3; P = 0.05). Children with PKU had more neophobia and were untrusting/fearful of new foods. Conclusions Although there was some evidence to suggest that children with PKU aged ≥4 years prefer savoury foods (vegetables) more than control children, they did not prefer bitter-tasting foods, and so early and persistent administration of bitter-tasting l-amino acids was not associated with apparent taste imprinting. Neophobia appears to play significant part in food refusal in PKU, perhaps more so than taste preferences. [ABSTRACT FROM AUTHOR]

Background Ageing is a multifaceted and inevitable process involving a decline in health and well-being that could be ameliorated by dietary modification. We review and discuss the evidence for nutritional interventions that may support healthy ageing. Methods The Preferred Reporting Items for Systematic Reviews and Meta-Analyses ( PRISMA) guidelines were used to identify randomised controlled trials investigating the role(s) of fatty acids and micronutrients in relation to markers of healthy ageing. Results European dietary surveys suggest that diets in elderly people are generally high in saturated fat, whereas intakes of vitamin D, magnesium, potassium, zinc and copper are below recommended levels. Thirty-four studies meeting the criteria were found, with 12 of these investigating the role of fatty acids and 22 considering intakes of micronutrients in relation to healthy ageing. Overall, these studies suggested that certain nutrients were consistent with healthy ageing; for example, omega-3 fatty acids were helpful for cognitive health, whereas combinations of calcium, vitamin D and K were linked with better bone health. Conclusions Vitamin, mineral and fatty acid intakes are in need of improvement to help elderly populations achieve optimal diet quality and support healthy ageing. This could involve the judicious use of supplements alongside dietary advice. Additional research is needed to determine optimal nutrient doses, combinations and forms in relation to desired health outcomes. [ABSTRACT FROM AUTHOR]

Background Heavy alcohol use during pregnancy can cause considerable developmental problems for children, but effects of light-moderate drinking are uncertain. This study examined possible effects of moderate drinking in pregnancy on children's conduct problems using a Mendelian randomisation design to improve causal inference. Methods A prospective cohort study ( ALSPAC) followed children from their mother's pregnancy to age 13 years. Analyses were based on 3,544 children whose mothers self-reported either not drinking alcohol during pregnancy or drinking up to six units per week without binge drinking. Children's conduct problem trajectories were classified as low risk, childhood-limited, adolescence-onset or early-onset-persistent, using six repeated measures of the Strengths and Difficulties Questionnaire between ages 4-13 years. Variants of alcohol-metabolising genes in children were used to create an instrumental variable for Mendelian randomisation analysis. Results Children's genotype scores were associated with early-onset-persistent conduct problems ( OR = 1.29, 95% CI = 1.04-1.60, p = .020) if mothers drank moderately in pregnancy, but not if mothers abstained from drinking ( OR = 0.94, CI = 0.72-1.25, p = .688). Children's genotype scores did not predict childhood-limited or adolescence-onset conduct problems. Conclusions This quasi-experimental study suggests that moderate alcohol drinking in pregnancy contributes to increased risk for children's early-onset-persistent conduct problems, but not childhood-limited or adolescence-onset conduct problems. [ABSTRACT FROM AUTHOR]

Background Active family engagement improves outcomes from adolescent inpatient care, but the impact on adult anorexia nervosa is uncertain. Aim The aim of this study was to describe the 2-year outcome following a pragmatic randomised controlled trial in which a skill training intervention (Experienced Caregivers Helping Others) for carers was added to inpatient care. Method Patient, caregiver and service outcomes were measured for 2 years following discharge from the index inpatient admission. Results There were small-sized/moderate-sized effects and consistent improvements in all outcomes from both patients and carers in the Experienced Caregivers Helping Others group over 2 years. The marked change in body mass index and carers' time caregiving following inpatient care was sustained. Approximately 20% of cases had further periods of inpatient care. Conclusion In this predominately adult anorexia nervosa sample, enabling carers to provide active support and management skills may improve the benefits in all symptom domains that gradually follow from a period of inpatient care. Copyright © 2015 John Wiley & Sons, Ltd and Eating Disorders Association. [ABSTRACT FROM AUTHOR]

Aims To explore health professionals' views about insulin pump therapy [continuous subcutaneous insulin infusion ( CSII)] and the types of individuals they thought would gain greatest clinical benefit from using this treatment. Methods In-depth interviews with staff ( n = 18) who delivered the Relative Effectiveness of Pumps Over MDI and Structured Education ( REPOSE) trial. Data were analysed thematically. Results Staff perceived insulin pumps as offering a better self-management tool to some individuals due to the drip feed of insulin, the ability to alter basal rates and other advanced features. However, staff also noted that, because of the diversity of features on offer, CSII is a more technically complex therapy to execute than multiple daily injections. For this reason, staff described how, alongside clinical criteria, they had tended to select individuals for CSII in routine clinical practice based on their perceptions about whether they possessed the personal and psychological attributes needed to make optimal use of pump technology. Staff also described how their assumptions about personal and psychological suitability had been challenged by working on the REPOSE trial and observing individuals make effective use of CSII who they would not have recommended for this type of therapy in routine clinical practice. Conclusions Our findings add to those studies that highlight the difficulties of using patient characteristics and variables to predict clinical success using CSII. To promote equitable access to CSII, attitudinal barriers and prejudicial assumptions amongst staff about who is able to make effective use of CSII may need to be addressed. [ABSTRACT FROM AUTHOR]

Physical activity may regulate affective experiences at work, but controlled studies are needed and there has been a reliance on retrospective accounts of experience. The purpose of the present study was to examine the effect of lunchtime walks on momentary work affect at the individual and group levels. Physically inactive employees ( N = 56; M age = 47.68; 92.86% female) from a large university in the UK were randomized to immediate treatment or delayed treatment ( DT). The DT participants completed both a control and intervention period. During the intervention period, participants partook in three weekly 30-min lunchtime group-led walks for 10 weeks. They completed twice daily affective reports at work (morning and afternoon) using mobile phones on two randomly chosen days per week. Multilevel modeling was used to analyze the data. Lunchtime walks improved enthusiasm, relaxation, and nervousness at work, although the pattern of results differed depending on whether between-group or within-person analyses were conducted. The intervention was effective in changing some affective states and may have broader implications for public health and workplace performance. [ABSTRACT FROM AUTHOR]

Background: Patients with heart failure and preserved ejection fraction (HFpEF) have a poor prognosis, and no therapies have been proven to improve outcomes. It has been proposed that heart failure, including HFpEF, represents overlapping syndromes that may have different prognoses. We present an exploratory study of patients enrolled in the Irbesartan in Heart Failure with Preserved Ejection Fraction Study (I-PRESERVE) using latent class analysis (LCA) with validation using the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM)-Preserved study to identify HFpEF subgroups.Methods and Results: In total, 4113 HFpEF patients randomized to irbesartan or placebo were characterized according to 11 clinical features. The HFpEF subgroups were identified using LCA. Event-free survival and effect of irbesartan on the composite of all-cause mortality and cardiovascular hospitalization were determined for each subgroup. Subgroup definitions were applied to 3203 patients enrolled in CHARM-Preserved to validate observations regarding prognosis and treatment response. Six subgroups were identified with significant differences in event-free survival (P < 0.001). Clinical profiles and prognoses of the six subgroups were similar in CHARM-Preserved. The two subgroups with the worst event-free survival in both studies were characterized by a high prevalence of obesity, hyperlipidaemia, diabetes mellitus, anaemia, and renal insufficiency (Subgroup C) and by female predominance, advanced age, lower body mass index, and high rates of atrial fibrillation, valvular disease, renal insufficiency, and anaemia (Subgroup F).Conclusion: Using a data-driven approach, we identified HFpEF subgroups with significantly different prognoses. Further development of this approach for characterizing HFpEF subgroups is warranted. [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]

The present research explores how justifications for indulgence influence the translation of 'good' intentions into action. Three studies investigated the nature of such justifications and their relation to indulgence. Study 1 identified six ways that people justify indulgence to themselves - that they are deserving or curious, that the indulgence is an exception to the norm or can be compensated for later, or that the tempting food is available or irresistible. Study 2 showed that the use of justifications undermined participants' strong (but not weak) intentions to halve their consumption of a nominated high-fat food. Study 3 found that priming the use of justifications increased the amount of chocolate that participants consumed in a subsequent, ostensibly unrelated, taste test. Again, justification use had a greater effect on participants with strong intentions to limit indulgence. Taken together, the studies suggest a new approach to understanding intention-behaviour discrepancies. [ABSTRACT FROM AUTHOR]

Background The increased availability of caffeinated drinks raises questions about the level of caffeine that is appropriate for children, as well as the benefits and risks associated with their consumption. Methods Using the Preferred Reporting Items for Systematic Reviews and Meta- Analyses guidelines, this systematic review evaluates evidence from randomised controlled trials investigating the effects of caffeine on cognition, behaviour, mood and exercise performance in children. Observational studies and expert panel guidelines are also discussed. Results One hundred and nine studies were found, with 11 randomised controlled trials and 13 observational studies meeting the criteria. High caffeine intakes (e.g. >5 mg kg-1 body weight day-1) were associated with an increased risk of anxiety and withdrawal symptoms. However, smaller amounts were not linked with such effects and may benefit cognitive function and sports performance based on adult studies. The evidence suggests that children and adolescents should limit daily caffeine consumption to 2.5 mg kg-1 body weight day-1, equating to one or two cups of tea or one small cup of coffee. Lower contributors of caffeine, such as tea, may be more appropriate for children because they contribute to daily fluid intakes and provide flavonoids. By contrast, caffeinated soft drinks may be less suitable options for children as a result of their acidity, higher caffeine content, presence of added sugar (in some cases) and absence of bioactive compounds. Conclusions More studies are needed to determine the intakes that represent a risk and whether there may be benefits for alertness and sports performance with moderate intakes of caffeine. [ABSTRACT FROM AUTHOR]

Background Little evidence exists for the effectiveness of therapy for children with receptive language difficulties, particularly those whose difficulties are severe and persistent. Aims To establish the effectiveness of explicit speech and language therapy with visual support for secondary school-aged children with language impairments focusing on comprehension of coordinating conjunctions in a randomized control trial with an assessor blind to group status. Methods & Procedures Fourteen participants (aged 11;3-16;1) with severe RELI (mean standard scores: CELF4 ELS = 48, CELF4 RLS = 53 and TROG-2 = 57), but higher non-verbal (Matrices = 83) and visual perceptual skills (Test of Visual Perceptual Skills (TVPS) = 86) were randomly assigned to two groups: therapy versus waiting controls. In Phase 1, the therapy group received eight 30-min individual sessions of explicit teaching with visual support (Shape Coding) with their usual SLT. In Phase 2, the waiting controls received the same therapy. The participants' comprehension was tested pre-, post-Phase 1 and post-Phase 2 therapy on (1) a specific test of the targeted conjunctions, (2) the TROG-2 and (3) a test of passives. Outcomes & Results After Phase 1, the therapy group showed significantly more progress than the waiting controls on the targeted conjunctions ( d = 1.6) and overall TROG-2 standard score ( d = 1.4). The two groups did not differ on the passives test. After Phase 2, the waiting controls made similar progress to those in the original therapy group, who maintained their previous progress. Neither group showed progress on passives. When the two groups were combined, significant progress was found on the specific conjunctions ( d = 1.3) and TROG-2 raw ( d = 1.1) and standard scores ( d = 0.9). Correlations showed no measures taken (including Matrices and TVPS) correlated significantly with progress on the targeted conjunctions or the TROG-2. Conclusions & Implications Four hours of Shape Coding therapy led to significant gains on comprehension of coordinating conjunctions which were maintained after 4 months. Given the significant progress at a group level and the lack of reliable predictors of progress, this approach could be offered to other children with similar difficulties to the participants. However, the intervention was delivered one-to-one by speech and language therapists, thus the effectiveness of this therapy method with other methods of delivery remains to be evaluated. [ABSTRACT FROM AUTHOR]

Background Neuromuscular electrical stimulation (NMES) has shown to improve skeletal muscle strength and exercise capacity in stable patients with chronic obstructive pulmonary disease (COPD). Variations in NMES protocols are considerable. We aimed to compare changes in muscle strength after high-frequency and low-frequency NMES in patients admitted to hospital with an acute exacerbation of COPD. Methods Patients were referred for inpatient (IP) rehabilitation during hospitalisation for an acute worsening of their COPD. They received 30-minute daily NMES to both quadriceps at a frequency of 35 or 50 Hz. NMES intensity was titrated to patients' tolerance. Isometric quadriceps muscle strength and endurance walking (ESWT) time were measured at baseline and on hospital discharge. Results A total of 10 patients in each treatment group underwent NMES during hospitalisation (mean [SD] age 68.0 [±7.4] years, FEV1 0.99 L [±0.58], FEV1/FVC 47% [± 27%], MRC 5 [IQR ±1]). There were no significant differences in baseline characteristics between groups. Muscle strength (legs combined) increased in both groups regardless of the NMES frequency used (35 Hz - 3.8 ± 4.9; 50 Hz - 3.4 ± 5.5 kg). This was only significant within the 35 Hz group. The change in ESWT also showed a trend to increase in both groups (35 Hz - 109 ± 92.7; 50 Hz - 145.6 ± 94.7). There was no significant difference between groups for either outcome. Conclusion NMES is a feasible intervention to improve muscle strength in a cohort of patients admitted with an exacerbation of COPD. The response appears to be independent of the frequency used and both were well-tolerated. Copyright © 2012 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Objectives We investigated the treatment effects reported from a high-quality randomized controlled trial of cognitive behavioural therapy ( CBT) for 106 people with borderline personality disorder attending community-based clinics in the UK National Health Service - the BOSCOT trial. Specifically, we examined whether the amount of therapy and therapist competence had an impact on our primary outcome, the number of suicidal acts, using instrumental variables regression modelling. Design Randomized controlled trial. Participants from across three sites ( London, Glasgow, and Ayrshire/ Arran) were randomized equally to CBT for personality disorders ( CBTpd) plus Treatment as Usual or to Treatment as Usual. Treatment as Usual varied between sites and individuals, but was consistent with routine treatment in the UK National Health Service at the time. CBTpd comprised an average 16 sessions (range 0-35) over 12 months. Method We used instrumental variable regression modelling to estimate the impact of quantity and quality of therapy received (recording activities and behaviours that took place after randomization) on number of suicidal acts and inpatient psychiatric hospitalization. Results A total of 101 participants provided full outcome data at 2 years post randomization. The previously reported intention-to-treat ( ITT) results showed on average a reduction of 0.91 (95% confidence interval 0.15-1.67) suicidal acts over 2 years for those randomized to CBT. By incorporating the influence of quantity of therapy and therapist competence, we show that this estimate of the effect of CBTpd could be approximately two to three times greater for those receiving the right amount of therapy from a competent therapist. Conclusions Trials should routinely control for and collect data on both quantity of therapy and therapist competence, which can be used, via instrumental variable regression modelling, to estimate treatment effects for optimal delivery of therapy. Such estimates complement rather than replace the ITT results, which are properly the principal analysis results from such trials. Practitioner points Assessing the impact of the quantity and quality of therapy (competence of therapists) is complex., More competent therapists, trained in CBTpd, may significantly reduce the number of suicidal act in patients with borderline personality disorder. [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]

Background: Representatives of counselling and person‐centred organisations indicate many of their members feel their profession and orientation is under threat, with counselling services being decommissioned in NHS settings. Aims: To understand the views of key figures in the psychological therapies field (policy makers, researchers and representatives of the counselling community) towards randomised controlled trials (RCTs), and their present and future role in developing the evidence‐base for counselling and psychotherapy. Method: Interviews (phone, Skype or face‐to‐face) were conducted with 24 authorities in the field. Relevant practitioner and academic networks were also contacted and key documents in the field were reviewed. Results: Key figures believe that RCTs will continue to play a decisive role in determining which psychological interventions are recommended and commissioned within the NHS for the foreseeable future. Other methods are seen as having some validity, but are generally considered supplementary to RCTs and not a replacement for them. Discussion: Although many members of the counselling community are critical of RCTs, they are likely to remain the mainstay of commissioning policy for some years to come. This means, in the coming years, members of the counselling community may face difficult choices in how to promote their work, while maintaining their core principles and values. [ABSTRACT FROM AUTHOR]

Aims To determine whether web-based tailored cessation advice, based on social cognitive theory and the perspectives on change model, was more effective in aiding a quit attempt than broadly similar web-based advice that was not tailored. Design Participants were allocated randomly to one of two groups, to receive either a cessation advice report and progress report that were tailored to individual-level characteristics or a cessation advice report that presented standardized (non-tailored) content. Tailoring was based on smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations. Setting Participant enrolment and baseline assessments were conducted remotely online via the study website, with the advice reports presented by the same website. Participants Participants ( n = 1758) were visitors to the QUIT website who were based in the United Kingdom, aged 18 years or over and who smoked cigarettes or hand-rolled tobacco. Measurements Follow-up assessments were made at 6 months by telephone interview. The primary outcome measure was self-reported 3 months prolonged abstinence, and secondary outcomes were 1 month prolonged abstinence, 7-day and 24-hour point prevalence abstinence. Findings The intervention group did not differ from the control group on the primary outcome (9.1% versus 9.3%; odds ratio = 1.02 95% confidence interval 0.73-1.42) or on any of the secondary outcomes. Intervention participants gave more positive evaluations of the materials than control participants. Conclusions A web-based intervention that tailored content according to smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations, was not more effective than web-based materials presenting broadly similar non-tailored information. [ABSTRACT FROM AUTHOR]

Objectives To evaluate the effectiveness of a self-help cognitive behavioral intervention in improving sleep quality in older adults reporting insomnia symptoms associated with chronic disease. Design A pragmatic two-arm randomized controlled trial comparing supported self-help with treatment as usual ( TAU). Setting Primary care. Participants One hundred ninety-three self-referred individuals aged 55 to 87 with long-term conditions and chronic insomnia symptoms (as defined according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition). Intervention Self-help participants received six consecutive booklets, at weekly intervals, providing structured advice on important components of cognitive behavioral therapy for insomnia ( CBT-I, including self-monitoring, sleep restriction, stimulus control procedures, and cognitive strategies), plus access to a telephone helpline. Control group participants received a single sheet of advice detailing standard sleep hygiene measures. Measurements The primary outcome was sleep quality, measured by the Pittsburgh Sleep Quality Index ( PSQI). Secondary outcomes were the Insomnia Severity Index ( ISI), the subjective sleep efficiency index, and the Fatigue Severity Scale. Results In the self-help group, sleep outcomes showed significant improvements after treatment ( PSQI, P < .001; ISI, P < .001; sleep efficiency, P < .001) and at 3-month ( PSQI, P = .002; ISI, P = .006; sleep efficiency, P = .001) and 6-month ( PSQI, P = .003; ISI, P = .003; sleep efficiency, P = .001) follow-up. Effect sizes were moderate (range of adjusted Cohen d = 0.51-0.75). Treatment had no effect on levels of daytime fatigue. Most treated participants (73%) said they would recommend the self-help program to others. Conclusion Self-help CBT-I offers a practical first-line response to individual reporting insomnia symptoms associated with chronic disease in primary care settings. In these individuals, symptoms of daytime fatigue may be more closely associated with disease processes than with sleep quality. [ABSTRACT FROM AUTHOR]

Background: Children who show disproportionate difficulty with the pragmatic as compared with the structural aspects of language are described as having pragmatic language impairment (PLI) or social communication disorder (SCD). Some children who have PLI also show mild social impairments associated with high-functioning autism or autism spectrum disorder (ASD). There is little robust evidence of effectiveness of speech-language interventions which target the language, pragmatic or social communication needs of these children. Aims: To evaluate the effectiveness of an intensive manualized social communication intervention (SCIP) for children who have PLI with or without features of ASD. Methods & Procedures: In a single-blind RCT design, 88 children with pragmatic and social communication needs aged 5;11-10;8, recruited from UK speech and language therapy services, were randomly assigned in a 2:1 ratio to SCIP or to treatment-as-usual. Children in the SCIP condition received up to 20 sessions of direct intervention from a specialist research speech and language therapist working with supervised assistants. All therapy content and methodology was derived from an intervention manual. A primary outcome measure of structural language and secondary outcome measures of narrative, parent-reported pragmatic functioning and social communication, blind-rated perceptions of conversational competence and teacher-reported ratings of classroom learning skills were taken pre-intervention, immediately post-intervention and at 6-month follow-up. Analysis was by intention to treat. Outcomes & Results: No significant treatment effect was found for the primary outcome measure of structural language ability or for a measure of narrative ability. Significant treatment effects were found for blind-rated perceptions of conversational competence, for parent-reported measures of pragmatic functioning and social communication, and for teacher-reported ratings of classroom learning skills. Conclusions & Implications: There is some evidence of an intervention effect on blind and parent/teacher-reported communication outcomes, but not standardized language assessment outcomes, for 6-11-year-old children who have pragmatic and social communication needs. These findings are discussed in the context of the increasingly central role of service user outcomes in providing evidence for an intervention. The substantial overlap between the presence of PLI and ASD (75%) across the whole cohort suggests that the intervention may also be applicable to some verbally able children with ASD who have pragmatic communication needs. [ABSTRACT FROM AUTHOR]

Background It is well recognized that breast milk is the best form of nutrition for babies. However, many women do not breastfeed or give up soon after birth. Some report feeling unsupported in the post-natal period and many stop breastfeeding earlier than they would have wished. This study aimed to estimate the separate effects of midwifery factors in the overall context of sociodemographic and clinical influences on breastfeeding. Methods Data from a national survey conducted in England in 2006 were used. Questionnaires were sent to a random sample of 4800 new mothers (63% response rate). Questions relating to infant feeding allowed calculation of rates of initiation of breastfeeding and rates of exclusive and any breastfeeding in the first few days and at 3 months. Univariate analyses were carried out to estimate the associations between sociodemographic, clinical and midwifery factors and breastfeeding. Logistic regression was used to estimate the specific effects of midwifery factors, while adjusting for other significant variables. Results The most powerful explanatory factor was antenatal feeding intention. Maternal age, absence of clinical problems in the baby and a short post-natal stay were important in the early days. At 3 months, breastfeeding was associated with sociodemographic and intrapartum factors. At all stages, breastfeeding was significantly associated with either receiving consistent advice, practical help and/or active support and encouragement from midwives. Conclusions The antenatal decision about infant feeding is the most powerful predictor of infant feeding behaviour. Some sociodemographic and clinical factors are also important influences on breastfeeding. However, after adjusting for these, midwifery factors are still influential. [ABSTRACT FROM AUTHOR]

the incidence of conduct disorder in young children is 10% in the general population and 37% among fostered children. Up to 40% of untreated children diagnosed with conduct disorder develop problems later in life including drug misuse, criminal and violent behaviour. There are more than 80 000 looked after children in the UK, with 5000 in Wales. Challenging child behaviour is the main reason for placement breakdown and has huge cost implications as challenging children cost up to 10 times more in service use than children without conduct disorder. The Incredible Years (IY) evidence-based parenting programme is an effective, low cost solution in improving child behaviour and social competence in 'conventional' families and thus has the potential to support foster carers in managing difficult behaviours. Our main aims were to establish: This was a 12-month trial platform study with 46 foster carers in three authorities in Wales. Carers were allocated 2:1 intervention to waiting-list control. Validated measures were used to assess 'parenting' competency, carers' depression levels, child behaviour and service use. Measures were administered at baseline and 6-month follow-up. Intervention carers received the programme between baseline and follow-up. Analyses showed a significant reduction in child problem behaviour and improvement in carers' depression levels for intervention families at follow-up, compared with control. Unexpectedly, there was a significant improvement in control carers' self-reported 'parenting' strategies. Special education was the greatest service cost for looked after children. Initial foster carer training could incorporate the IY programme to support carers in establishing positive relationships and managing difficult child behaviour. Programme participation may lead to reduced service use and improved placement stability. [ABSTRACT FROM AUTHOR]

Background: A manualized language therapy developed via a randomized controlled trial had proved efficacious in the short-term in developing expressive language for mainstream primary school children with persistent language impairment. This therapy had been delivered to a predetermined schedule by speech and language therapists or speech and language therapy assistants to children individually or in groups. However, this model of service delivery is no longer the most common model in UK schools, where indirect consultancy approaches with intervention delivered by school staff are often used. Aims: A cohort study was undertaken to investigate whether the therapy was equally efficacious when delivered to comparable children by school staff, rather than speech and language therapists or speech and language therapy assistants. Methods & Procedures: Children in the cohort study were selected using the same criteria as in the randomized controlled trial, and the same manualized therapy was used, but delivered by mainstream school staff using a consultancy model common in the UK. Outcomes were compared with those of randomized controlled trial participants. Outcomes & Results: The gains in expressive language measured in the randomized controlled trial were not replicated in the cohort study. Less language-learning activity was recorded than had been planned, and less than was delivered in the randomized controlled trial. Implications for 'consultancy' speech and language therapist service delivery models in mainstream schools are outlined. Conclusions & Implications: At present, the more efficacious therapy is that delivered by speech and language therapists or speech and language therapy assistants to children individually or in groups. This may be related to more faithful adherence to the interventions schedule, and to a probably greater amount of language-learning activity undertaken. Intervention delivered via school-based 'consultancy' approaches in schools will require to be carefully monitored by schools and SLT services. [ABSTRACT FROM AUTHOR]

We describe instrumental variable (IV) methods for the estimation of the 'dose'-response effects of psychological interventions in randomized controlled trials in which there is variability in the patients' adherence to the allocated therapy (that is, variability in the actual number of sessions of therapy attended) and also variability in the strength of the therapeutic alliance between patients and their therapists. The effect of the therapy on outcome is assumed to be a function of both the number of sessions attended and the strength of the therapeutic alliance, with no intervention effects in the absence of any sessions attended (an exclusion restriction) and the effect of the strength of the alliance being represented by a multiplicative term (interaction) in the treatment-effect model. The IV methods that are described allow for: (a) hidden confounding between sessions, alliance and outcome; (b) measurement errors in the alliance; and (c) that alliance is only measured in those receiving treatment. Three two-stage estimation procedures are illustrated, and their equivalence demonstrated, through Monte Carlo simulation and analysis of the results of an actual trial. [ABSTRACT FROM AUTHOR]

The UK has low breastfeeding rates, with socioeconomic disparities. The Assets‐based feeding help Before and After birth (ABA) intervention was designed to be inclusive and improve infant feeding behaviours. ABA is underpinned by the behaviour change wheel and offers an assets‐based approach focusing on positive capabilities of individuals and communities, including use of a Genogram. This study aimed to investigate feasibility of intervention delivery within a randomised controlled trial (RCT). Nulliparous women ≥16 years, (n = 103) from two English sites were recruited and randomised to either intervention or usual care. The intervention – delivered through face‐to‐face, telephone and text message by trained Infant Feeding Helpers (IFHs) – ran from 30‐weeks' gestation until 5‐months postnatal. Outcomes included recruitment rates and follow‐up at 3‐days, 8‐weeks and 6‐months postnatal, with collection of future full trial outcomes via questionnaires. A mixed‐methods process evaluation included qualitative interviews with 30 women, 13 IFHs and 17 maternity providers; IFH contact logs; and fidelity checking of antenatal contact recordings. This study successfully recruited women, including teenagers, from socioeconomically disadvantaged areas; postnatal follow‐up rates were 68.0%, 85.4% and 80.6% at 3‐days, 8‐weeks and 6‐months respectively. Breastfeeding at 8‐weeks was obtained for 95.1% using routine data for non‐responders. It was possible to recruit and train peer supporters to deliver the intervention with adequate fidelity. The ABA intervention was acceptable to women, IFHs and maternity services. There was minimal contamination and no evidence of intervention‐related harm. In conclusion, the intervention is feasible to deliver within an RCT, and a definitive trial required. [ABSTRACT FROM AUTHOR]

Aim Peer-assisted learning ( PAL) has been positively evaluated during practice placements for medical, nursing and some allied health professional students. The aim of this study was to evaluate a PAL and small-group teaching model of dietetic practice placement education implemented in the UK setting as part of a quality improvement process. Methods A PAL placement model was adapted from a previously published Australian model, implemented and evaluated among dietetic students at King's College London and with their practice educators. Process evaluation with students and practice educators from PAL practice placements at two sites and traditional 1:1 practice placements at six sites consisted of weekly questionnaires and end-of-placement focus groups with 16 students and 35 practice educators. Perceptions of the barriers, concerns and strengths of the novel model were identified. Results Implementing the PAL placement model at just two sites increased placement capacity by 12 students, a 1.3-fold increase across London. Students on PAL placements reported a good learning experience (89.3 vs 67.7%; P < 0.001) and a satisfactory workload (83.1 vs 61.3%, P = 0.005) more frequently than those on a traditional 1:1 placement. Practice educators reported significantly less time undertaking direct student supervision on PAL practice placements compared to 1:1 placements (153 minutes/week 95% confidence interval ( CI) 124-183 vs 264 minutes/week 95% CI 204-324; P = 0.001). Conclusions PAL practice placements offer potential benefits to placement capacity and possibly quality. The detailed evaluation will enable others to implement similar novel models of dietetics placements. [ABSTRACT FROM AUTHOR]