Abstract
. Background: it is unclear whether people with dementia (PwD) have more negative attitudes toward own aging (ATOA) than people without dementia and what factors influence ATOA among PwD. We investigated whether PwD have more negative ATOA than individuals without dementia and whether cognition and dementia subtype are associated with ATOA in PwD.Methods: Data from the IDEAL and PROTECT studies were used to compare ATOA between 1,502 PwD (mean (SD) age = 76.3 (8.5)) and 6,377 individuals without dementia (mean (SD) age = 66.1 (7.1)). Linear regressions and ANOVA were used.Results: PwD reported slightly more negative ATOA than people without dementia; this relationship disappeared after controlling for depression and self-rated health. In PwD more positive ATOA showed negligible associations with better general cognition, memory performance, verbal fluency, and visuospatial ability. However, after adjusting for covariates only better visuospatial ability predicted more positive ATOA. Additional analyses showed that before and after controlling for covariates, individuals with poorer self-reported visual acuity have more negative ATOA. Amongst dementia subtypes, people with Parkinson’s disease dementia and dementia with Lewy bodies reported most negative ATOA. Conclusions: ATOA between PwD and people without dementia do not differ. ATOA in PwD appear to be affected not by cognitive impairment but by other characteristics that vary across dementia subtypes. Among PwD, those with Parkinson’s disease dementia and dementia with Lewy bodies may have higher risk of experiencing negative ATOA due to the motor and visual impairments that they experience.

Abstract
. Higher awareness of positive age-related changes (AARC gains) is related to better mental health, whereas higher awareness of negative age-related changes (AARC losses) is related to poorer mental and physical health. So far perceived gains and losses have been explored separately, but people report gains and losses concurrently in varying degrees, and different profiles of gains and losses may be differentially associated with health. We identified profiles of gains and losses and explored whether different profiles differed in physical, mental, and cognitive health. We used cross-sectional data from the PROTECT study (N= 6,192; mean(SD) age= 66.1(7.0)). Using latent profile analysis, a four-class solution showed the best model fit. We found that 45% of people perceived many gains and few losses (Class 1); 24% perceived moderate gains and few losses (Class 2); 24% perceived many gains and moderate losses (Class 3); 7% perceived many gains and many losses (Class 4). Analysis of variance and Chi-square tests showed that Class 1 had relatively better physical, mental, and cognitive health, followed by Classes 2, 3, and 4. Experiencing one’s ageing to a high degree as gain may be related to better health only when individuals interpret ageing as involving low levels of loss across several life domains. Risk in terms of poorer health emerged in those who perceived high losses. Considering gains and losses in parallel, rather than separately, may lead to a more fine-tuned understanding of relations with health.

Higher awareness of positive age-related changes (AARC gains) is related to better mental health, whereas higher awareness of negative age-related changes (AARC losses) is related to poorer mental and physical health. So far perceived gains and losses have been explored separately, but people report gains and losses concurrently in varying degrees, and different profiles of gains and losses may be differentially associated with health. We identified profiles of gains and losses and explored whether different profiles differed in physical, mental, and cognitive health.
We used cross-sectional data from the PROTECT study (N= 6,192; mean (SD) age= 66.1(7.0)).
Using latent profile analysis, a four-class solution showed the best model fit. We found that 45% of people perceived many gains and few losses (Class 1); 24% perceived moderate gains and few losses (Class 2); 24% perceived many gains and moderate losses (Class 3); 7% perceived many gains and many losses (Class 4). Analysis of variance and Chi-squared tests showed that Class 1 had relatively better physical, mental, and cognitive health, followed by Classes 2, 3, and 4.
Experiencing one’s ageing to a high degree as gain may be related to better health only when individuals interpret ageing as involving low levels of loss across several life domains. Risk in terms of poorer health emerged in those who perceived high losses. Considering gains and losses in parallel, rather than separately, may lead to a more fine-tuned understanding of relations with health.

Background
For most cancers, only a minority of patients have symptoms meeting the National Institute for Health and Clinical Excellence guidance for urgent referral. For gastro-oesophageal cancers, the ‘alarm’ symptoms of dysphagia and weight loss are reported by only 32% and 8% of patients respectively and their presence correlates with advanced stage disease. Electronic clinical decision support tools which integrate with clinical computer systems have been developed for general practice, although there is uncertainty about their effectiveness. The objectives of this trial are to optimise the intervention and establish acceptability of both the intervention and randomisation; confirm the suitability and selection of outcome measures; finalise design for the phase III definitive trial; and obtain preliminary estimates of the intervention effect.

Methods/Design
This is a two-arm, multi-centre, cluster randomised controlled phase II trial design, over a 16-month period, across 60 general practices within the North East & North Cumbria and Eastern Local Clinical Research Network areas. Practices will be randomised to receive either the intervention (electronic clinical decision support tool) or to act as control (usual care). From these practices, we will recruit 3000 adults who meet the trial eligibility criteria and present to their GP with symptoms potentially of gastro-oesophageal cancer. The main measures are process data, to include practitioner outcomes, service outcomes, diagnostic intervals, health economic outcomes and patient outcomes. 1:1 interviews in a sub-sample of 30 patient-GP dyads, will be undertaken to understand the impact of the use or non-use of the electronic clinical decision support tool in the consultation. A further 10-15 GPs will be interviewed to identify and gain an understanding of the facilitators and constraints influencing implementation of the electronic clinical decision support tool in practice.

Discussion
We aim to generate new knowledge on the process measures regarding use of electronic clinical decision support tools in primary care in general and to inform a subsequent definitive phase III trial. Preliminary data on the impact on resource utilisation and health care costs of the support tool will also be collected.

Abstract
. Background: a questionnaire assessing awareness of positive and negative age-related changes (AARC gains and losses) was developed in the US and Germany. We validated the short form of the measure (AARC-10 SF) and the cognitive functioning subscale from the 50-item version of the AARC (AARC-50) questionnaire in the UK population aged 50 and over.Methods: Data from 14,797 participants in the “blind for review” cohort were used to explore and confirm the psychometric properties of the AARC measures including: validity of the factor structure; reliability; measurement invariance across males and females and across individuals with and without a university degree; and convergent validity with measures of self-perception of aging and mental, physical, and cognitive health. We also explored the relationship between demographic variables and AARC.Results: We confirmed the two-factor structure (gains and losses) of the AARC-10 SF and the AARC-50 cognitive functioning subscale. Both scales showed good reliability and convergent validity. The meaning of AARC gains and losses was the same across males and females and across individuals with and without a university degree. Items composing AARC scales had the same meaning across individuals with and without a university degree. Items composing the AARC-50 cognitive functioning subscale had the same meaning across males and females. Two items in the AARC-10 SF had different meaning across males and females. Demographic variables significantly predicted AARC gains and losses.Conclusions: the AARC-10 SF and AARC-50 cognitive functioning subscale can help to identify UK individuals who perceive age-related changes in their mental, physical, and cognitive health.

Abstract
. Background: a questionnaire assessing awareness of positive and negative age-related changes (AARC gains and losses) was developed in the US and Germany. We validated the short form of the measure (AARC-10 SF) and the cognitive functioning subscale from the 50-item version of the AARC (AARC-50) questionnaire in the UK population aged 50 and over. Methods: Data from 9,410 participants (Mean (SD) age= 65.9 (7.1)) in the PROTECT cohort were used to explore and confirm the psychometric properties of the AARC measures including: validity of the factor structure; reliability; measurement invariance across men and women, individuals with and without a university degree, and in middle age, early old age, and advanced old age; and convergent validity with measures of self-perception of aging and mental, physical, and cognitive health. We explored the relationship between demographic variables (age, sex, marital status, employment, and university education) and AARC. Results: We confirmed the two-factor structure (gains and losses) of the AARC-10 SF and the AARC-50 cognitive functioning subscale. Both scales showed good reliability and good convergent validity for AARC losses, but weak convergent validity for AARC gains. For both scales metric invariance was held for the two subgroups defined by education level and age. For the AARC-50 subscale, but not for the AARC-10 SF, strong invariance was also held for the two subgroups defined by sex. Age, sex, marital status, employment, and university education predicted AARC gains and losses. Conclusions: the AARC-10 SF and AARC-50 cognitive functioning subscale identify UK individuals who perceive age-related changes in their mental, physical, and cognitive health.

Parental depression can adversely affect parenting and children's development. We adapted mindfulness-based cognitive therapy (MBCT) for parents (MBCT-P) with a history of depression and describe its development, feasibility, acceptability and preliminary estimates of efficacy. Manual development involved interviews with 12 parents who participated in MBCT groups or pilot MBCT-P groups. We subsequently randomised 38 parents of children aged between 2 and 6 years to MBCT-P plus usual care (n=19) or usual care (n=19). Parents were interviewed to assess the acceptability of MBCT-P. Preliminary estimates of efficacy in relation to parental depression. and children’s behaviour were calculated at 4 and 9 months post-randomisation. Levels of parental stress, mindfulness and self-compassion were measured. Interviews confirmed the acceptability of MBCT-P; 78% attended at least half the sessions. In the pilot RCT, at 9 months, depressive symptoms in the MBCT-P arm were lower than in the usual care arm (adjusted mean difference = -7.0; 95% CI: -12.8 to -1.1; p=0.02) and eleven participants (58%) in the MBCT-P arm remained well compared to six (32%) in the usual care arm (mean difference = 26%; 95% CI: -4% to 57%; p = 0.02). Levels of mindfulness (p=0.01) and self-compassion (p =

ABSTRACTBackgroundThrombocytosis is associated with poor lung cancer prognosis and has recently been identified as having a high predictive value in lung cancer detection. Lung cancer has multiple histological and genetic subtypes and it is not known whether platelet levels differ across subtypes.MethodsPubMed and Embase were systematically searched for studies that reported pre-treatment platelet count, as either averages or proportion of patients with thrombocytosis, by histological subtype of lung cancer. Suitable studies were synthesised in meta-analyses; subgroup analyses examined for differences across subtypes.ResultsThe prevalence of pre-treatment thrombocytosis across all lung cancer patients was 27% (95% CI: 17 to 37%). By subtype, this was 22% (95% CI: 7 to 41%) for adenocarcinoma (ADC), 28% (95% CI: 15 to 43%) for squamous cell carcinoma (SCC), 36% (95% CI: 13 to 62%) for large cell carcinoma, and 30% (95% CI: 8 to 58%) for small cell lung cancer (SCLC). The pooled mean platelet count for lung cancer patients was 289×109 /L (95% CI: 268 to 311). By subtype, this was 282×109 /L (95% CI: 259 to 306) for ADC, 297×109 /L (95% CI: 238 to 356) for SCC, 290×109 /L (95% CI: 176 to 404) for LCC, and 293×109 /L (95% CI: 244 to 342) for SCLC. There was no difference in thrombocytosis prevalence (p=0.76) or mean platelet count (p=0.96) across the subtypes.ConclusionWe report no evidence of differences in platelet levels across the major subtypes of lung cancer. A high platelet level is likely to be generic across all lung cancer subtypes.KEY MESSAGESWhat is the key question?Which (if any) subtype(s) of lung cancer are more associated with thrombocytosis?What is the bottom line?This can facilitate lung cancer diagnostics and provide insights into the biological mechanism between lung cancer and thrombocytosis.Why read on?This is the first systematic review to compare platelet count across different subtypes of lung cancer, combining data from 9,891 patients across 38 studies.

Abstract
. Background: a questionnaire assessing awareness of positive and negative age-related changes (AARC gains and losses) was developed in the US and Germany. We validated the short form of the measure (AARC-10 SF) and the cognitive functioning subscale from the 50-item version of the AARC (AARC-50) questionnaire in the UK population aged 50 and over. Methods: Data from 14,797 participants in the PROTECT cohort were used to explore and confirm the psychometric properties of the AARC measures including: validity of the factor structure; reliability; measurement invariance across males and females and across individuals with and without a university degree; and convergent validity with measures of self-perception of aging and mental, physical, and cognitive health. We also explored the relationship between demographic variables and AARC. Results: We confirmed the two-factor structure (gains and losses) of the AARC-10 SF and the AARC-50 cognitive functioning subscale. Both scales showed good reliability and convergent validity. The meaning of AARC gains and losses was the same across males and females and across individuals with and without a university degree. Items composing AARC scales had the same meaning across individuals with and without a university degree. Items composing the AARC-50 cognitive functioning subscale had the same meaning across males and females. Two items in the AARC-10 SF had different meaning across males and females. Demographic variables significantly predicted AARC gains and losses. Conclusions: the AARC-10 SF and AARC-50 cognitive functioning subscale can help to identify UK individuals who perceive age-related changes in their mental, physical, and cognitive health.

Objectives:
1. To examine the relationship between mothers’ health-related quality of life (HRQoL) and child behaviour problems at age 2 years.
2. To investigate whether the relationship between maternal HRQoL and child behaviour problems is independent of maternal mental health.

Methods:
Design: Cross-sectional survey nested within a population-level, cluster randomised trial which aims to prevent early child behaviour problems.
Participants: 1160 mothers of two year old children, in nine Local Government Areas in Victoria, Australia.
Measures: HRQoL was measured using the Assessment of Quality of Life (AQoL-6D) and child behaviour was measured using the Child Behavior Checklist (CBCL/1.5-5 years). Maternal mental health was measured using the Depression Anxiety Stress Scale (DASS). Data were collected at child age 2 years; demographic data were collected at child age 8 months.

Results: HRQoL was lower for mothers with children that had borderline/clinical behaviour problems compared to those with children without problems (mean difference -0.14, 95% CI: -0.16 to -0.12, p

Background: This study investigated ethnic differences in diagnostic interval (DI)—the period between initial primary care presentation and diagnosis. Methods: We analysed the primary care-linked data of patients who reported features of seven cancers (breast, lung, prostate, colorectal, oesophagogastric, myeloma, and ovarian) one year before diagnosis. Accelerated failure time (AFT) models investigated the association between DI and ethnicity, adjusting for age, sex, deprivation, and morbidity. Results: of 126,627 eligible participants, 92.1% were White, 1.99% Black, 1.71% Asian, 1.83% Mixed, and 2.36% were of Other ethnic backgrounds. Considering all cancer sites combined, the median (interquartile range) DI was 55 (20–175) days, longest in lung [127, (42–265) days], and shortest in breast cancer [13 (13, 8–18) days]. DI for the Black and Asian groups was 10% (AFT ratio, 95%CI 1.10, 1.05–1.14) and 16% (1.16, 1.10–1.22), respectively, longer than for the White group. Site-specific analyses revealed evidence of longer DI in Asian and Black patients with prostate, colorectal, and oesophagogastric cancer, plus Black patients with breast cancer and myeloma, and the Mixed group with lung cancer compared with White patients. DI was shorter for the Other group with lung, prostate, myeloma, and oesophagogastric cancer than the White group. Conclusion: We found limited and inconsistent evidence of ethnic differences in DI among patients who reported cancer features in primary care before diagnosis. Our findings suggest that inequalities in diagnostic intervals, where present, are unlikely to be the sole explanation for ethnic variations in cancer outcomes.

Abstract
. Background
. It is unclear whether people with dementia (PwD) have more negative attitudes toward own aging (ATOA) than people without dementia and what factors influence ATOA among PwD. We investigated whether PwD have more negative ATOA than individuals without dementia and whether cognition and dementia subtype are associated with ATOA in PwD.
.
. Methods
. Data from the IDEAL and PROTECT studies were used to compare ATOA between 1502 PwD (mean (SD) age = 76.3 (8.5)) and 6377 individuals without dementia (mean (SD) age = 66.1 (7.1)). Linear regressions and ANOVA were used.
.
. Results
. PwD reported slightly more negative ATOA than people without dementia; this relationship disappeared after controlling for depression and self-rated health. In PwD more positive ATOA showed negligible associations with better general cognition, memory performance, verbal fluency, and visuospatial ability. However, after adjusting for covariates only better visuospatial ability predicted more positive ATOA. Additional analyses showed that before and after controlling for covariates, individuals with poorer self-reported visual acuity have more negative ATOA. Amongst dementia subtypes, people with Parkinson’s disease dementia and dementia with Lewy bodies reported most negative ATOA.
.
. Conclusions
. ATOA between PwD and people without dementia do not differ. ATOA in PwD appear to be affected not by cognitive impairment but by other characteristics that vary across dementia subtypes. Among PwD, those with Parkinson’s disease dementia and dementia with Lewy bodies may have higher risk of experiencing negative ATOA due to the motor and visual impairments that they experience.
.

Higher awareness of positive age-related changes (AARC gains) is related to better mental health, whereas higher awareness of negative age-related changes (AARC losses) is related to poorer mental and physical health. So far perceived gains and losses have been explored separately, but people report gains and losses concurrently in varying degrees, and different profiles of gains and losses may be differentially associated with health. We identified profiles of gains and losses and explored whether different profiles differed in physical, mental, and cognitive health. We used cross-sectional data from the PROTECT study (N = 6192; mean (SD) age = 66.1 (7.0)). Using latent profile analysis, a four-class solution showed the best model fit. We found that 45% of people perceived many gains and few losses (Class 1); 24% perceived moderate gains and few losses (Class 2); 24% perceived many gains and moderate losses (Class 3); 7% perceived many gains and many losses (Class 4). Analysis of variance and Chi-squared tests showed that Class 1 had relatively better physical, mental, and cognitive health, followed by Classes 2, 3, and 4. Experiencing one's ageing to a high degree as gain may be related to better health only when individuals interpret ageing as involving low levels of loss across several life domains. Risk in terms of poorer health emerged in those who perceived high losses. Considering gains and losses in parallel, rather than separately, may lead to a more fine-tuned understanding of relations with health.

BACKGROUND: UK Asian and Black ethnic groups have poorer outcomes for some cancers and are less likely to report a positive care experience than their White counterparts. This study investigated ethnic differences in the route to diagnosis (RTD) to identify areas in patients' cancer journeys where inequalities lie, and targeted intervention might have optimum impact. METHODS: We analysed data of 243,825 patients with 10 cancers (2006-2016) from the RTD project linked to primary care data. Crude and adjusted proportions of patients diagnosed via six routes (emergency, elective GP referral, two-week wait (2WW), screen-detected, hospital, and Other routes) were calculated by ethnicity. Adjusted odds ratios (including two-way interactions between cancer and age, sex, IMD, and ethnicity) determined cancer-specific differences in RTD by ethnicity. RESULTS: Across the 10 cancers studied, most patients were diagnosed via 2WW (36.4%), elective GP referral (23.2%), emergency (18.2%), hospital routes (10.3%), and screening (8.61%). Patients of Other ethnic group had the highest proportion of diagnosis via the emergency route, followed by White patients. Asian and Black group were more likely to be GP-referred, with the Black and Mixed groups also more likely to follow the 2WW route. However, there were notable cancer-specific differences in the RTD by ethnicity. CONCLUSION: Our findings suggest that, where inequalities exist, the adverse cancer outcomes among Asian and Black patients are unlikely to be arising solely from a poorer diagnostic process.

OBJECTIVES: Older people describe positive and negative age-related changes, but we do not know much about what contributes to make them aware of these changes. We used content analysis to categorize participants' written comments and explored the extent to which the identified categories mapped onto theoretical conceptualizations of influences on awareness of age-related change (AARC). DESIGN: Cross-sectional observational study. PARTICIPANTS: the study sample comprised 609 UK individuals aged 50 years or over (mean (SD) age = 67.9 (7.6) years), enrolled in the PROTECT study. MEASUREMENTS: Between January and March 2019, participants provided demographic information, completed a questionnaire assessing awareness of age-related change (AARC-10 SF), and responded to an open-ended question asking them to comment on their responses. RESULTS: While some of the emerging categories were in line with the existing conceptual framework of AARC (e.g. experiencing negative changes and attitudes toward aging), others were novel (e.g. engagement in purposeful activities or in activities that distract from age-related thoughts). Analysis revealed some of the thought processes involved in selecting responses to the questionnaire items, demonstrating different ways in which people make sense of specific items. CONCLUSIONS: Results support the ability of the AARC questionnaire to capture perceived age-related changes in cognitive functioning, physical and mental health, and engagement in social activities and in healthy and adaptive behaviors. However, findings also suggest ways of enriching the theoretical conceptualization of how AARC develops and offer insights into interpretation of responses to measures of AARC.

BACKGROUND: the healthy context paradox, originally described with respect to school-level bullying interventions, refers to the generation of differences in mental wellbeing amongst those who continue to experience bullying even after interventions successfully reduce victimisation. Using data from the INCLUSIVE trial of restorative practice in schools, we relate this paradox to the need to theorise potential harms when developing interventions; formulate the healthy context paradox in a more general form defined by mediational relationships and cluster-level interventions; and propose two statistical models for testing the healthy context paradox informed by multilevel mediation methods, with relevance to structural and individual explanations for this paradox. METHODS: We estimated two multilevel mediation models with bullying victimisation as the mediator and mental wellbeing as the outcome: one with a school-level interaction between intervention assignment and the mediator; and one with a random slope component for the student-level mediator-outcome relationship predicted by school-level assignment. We relate each of these models to contextual or individual-level explanations for the healthy context paradox. RESULTS: Neither model suggested that the INCLUSIVE trial represented an example of the healthy context paradox. However, each model has different interpretations which relate to a multilevel understanding of the healthy context paradox. CONCLUSIONS: Greater exploration of intervention harms, especially when those accrue to population subgroups, is an essential step in better understanding how interventions work and for whom. Our proposed tests for the presence of a healthy context paradox provide the analytic tools to better understand how to support development and implementation of interventions that work for all groups in a population. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN10751359.

There is evidence that universal school-based mindfulness training (SBMT) can have positive effects for young people. However, it is unknown who benefits most from such training, how training exerts effects, and how implementation impacts effects. This study aimed to provide an overview of the evidence on the mediators, moderators, and implementation factors of SBMT, and propose a conceptual model that can be used both to summarize the evidence and provide a framework for future research. A scoping review was performed, and six databases and grey literature were searched. Inclusion and exclusion criteria were applied to select relevant material. Quantitative and qualitative information was extracted from eligible articles and reported in accordance with PRISMA-ScR guidelines. The search produced 5479 articles, of which 31 were eligible and included in the review. Eleven studies assessed moderators of SBMT on pupil outcomes, with mixed findings for all variables tested. Five studies examined the mediating effect of specific variables on pupil outcomes, with evidence that increases in mindfulness skills and decreases in cognitive reactivity and self-criticism post-intervention are related to better pupil outcomes at follow-up. Twenty-five studies assessed implementation factors. We discuss key methodological shortcomings of included studies and integrate our findings with existing implementation frameworks to propose a conceptual model. Widespread interest in universal SBMT has led to increased research over recent years, exploring who SBMT works for and how it might work, but the current evidence is limited. We make recommendations for future research and provide a conceptual model to guide theory-led developments.

INTRODUCTION: Anxiety difficulties are among the most common mental health problems in childhood. Despite this, few children access evidence-based interventions, and school may be an ideal setting to improve children's access to treatment. This article describes the design, methods and expected data collection of the Identifying Child Anxiety Through Schools - Identification to Intervention (iCATS i2i) study, which aims to develop acceptable school-based procedures to identify and support child anxiety difficulties. METHODS AND ANALYSIS: iCATS i2i will use a mixed-methods approach to codesign and deliver a set of procedures-or 'pathway'-to improve access to evidence-based intervention for child anxiety difficulties through primary schools in England. The study will consist of four stages, initially involving in-depth interviews with parents, children, school staff and stakeholders (stage 1) to inform the development of the pathway. The pathway will then be administered in two primary schools, including screening, feedback to parents and the offer of treatment where indicated (stage 2), with participating children, parents and school staff invited to provide feedback on their experience (stages 3 and 4). Data will be analysed using Template Analysis. ETHICS AND DISSEMINATION: the iCATS i2i study was approved by the University of Oxford's Research Ethics Committee (REF R64620/RE001). It is expected that this codesign study will lead on to a future feasibility study and, if indicated, a randomised controlled trial. The findings will be disseminated in several ways, including via lay summary report, publication in academic journals and presentation at conferences. By providing information on child, parent, school staff and other stakeholder's experiences, we anticipate that the findings will inform the development of an acceptable evidence-based pathway for identification and intervention for children with anxiety difficulties in primary schools and may also inform broader approaches to screening for and treating youth mental health problems outside of clinics.

ObjectiveTo determine the feasibility of a definitive trial in primary care of electronic clinical decision support (eCDS) for possible oesophago-gastric (O-G) cancer.Design and settingFeasibility study in 42 general practices in two regions of England, cluster randomised controlled trial design without blinding, nested qualitative and health economic evaluation.ParticipantsPatients aged 55 years or older, presenting to their general practitioner (GP) with symptoms associated with O-G cancer. 530 patients (mean age 68 years, 58% female) participated.InterventionPractices randomised 1:1 to usual care (control) or to receive a previously piloted eCDS tool for suspected cancer (intervention), for use at the discretion of the GPs, supported by a theory-based implementation package and ongoing support. We conducted semistructured interviews with GPs in intervention practices. Recruitment lasted 22 months.OutcomesPatient participation rate, use of eCDS, referrals and route to diagnosis, O-G cancer diagnoses; acceptability to GPs; cost-effectiveness. Participants followed up 6 months after index encounter.ResultsFrom control and intervention practices, we screened 3841 and 1303 patients, respectively; 1189 and 434 were eligible, 392 and 138 consented to participate. Ten patients (1.9%) had O-G cancer. eCDS was used eight times in total by five unique users. GPs experienced interoperability problems between the eCDS tool and their clinical system and also found it did not fit with their workflow. Unexpected restrictions on software installation caused major problems with implementation.ConclusionsThe conduct of this study was hampered by technical limitations not evident during an earlier pilot of the eCDS tool, and by regulatory controls on software installation introduced by primary care trusts early in the study. This eCDS tool needed to integrate better with clinical workflow; even then, its use for suspected cancer may be infrequent. Any definitive trial of eCDS for cancer diagnosis should only proceed after addressing these constraints.Trial registration numberISRCTN125595588.

BACKGROUND: Dementia is a syndrome that comprises many differing pathologies, including Alzheimer's disease dementia (ADD), vascular dementia (VaD) and frontotemporal dementia (FTD). People may benefit from knowing the type of dementia they live with, as this could inform prognosis and may allow for tailored treatment. Beta-amyloid (1-42) (ABeta42) is a protein which decreases in both the plasma and cerebrospinal fluid (CSF) of people living with ADD, when compared to people with no dementia. However, it is not clear if changes in ABeta42 are specific to ADD or if they are also seen in other types of dementia. It is possible that ABeta42 could help differentiate ADD from other dementia subtypes. OBJECTIVES: to determine the accuracy of plasma and CSF ABeta42 for distinguishing ADD from other dementia subtypes in people who meet the criteria for a dementia syndrome. SEARCH METHODS: We searched MEDLINE, and nine other databases up to 18 February 2020. We checked reference lists of any relevant systematic reviews to identify additional studies. SELECTION CRITERIA: We considered cross-sectional studies that differentiated people with ADD from other dementia subtypes. Eligible studies required measurement of participant plasma or CSF ABeta42 levels and clinical assessment for dementia subtype. DATA COLLECTION AND ANALYSIS: Seven review authors working independently screened the titles and abstracts generated by the searches. We collected data on study characteristics and test accuracy. We used the second version of the 'Quality Assessment of Diagnostic Accuracy Studies' (QUADAS-2) tool to assess internal and external validity of results. We extracted data into 2 x 2 tables, cross-tabulating index test results (ABeta42) with the reference standard (diagnostic criteria for each dementia subtype). We performed meta-analyses using bivariate, random-effects models. We calculated pooled estimates of sensitivity, specificity, positive predictive values, positive and negative likelihood ratios, and corresponding 95% confidence intervals (CIs). In the primary analysis, we assessed accuracy of plasma or CSF ABeta42 for distinguishing ADD from other mixed dementia types (non-ADD). We then assessed accuracy of ABeta42 for differentiating ADD from specific dementia types: VaD, FTD, dementia with Lewy bodies (DLB), alcohol-related cognitive disorder (ARCD), Creutzfeldt-Jakob disease (CJD) and normal pressure hydrocephalus (NPH). To determine test-positive cases, we used the ABeta42 thresholds employed in the respective primary studies. We then performed sensitivity analyses restricted to those studies that used common thresholds for ABeta42. MAIN RESULTS: We identified 39 studies (5000 participants) that used CSF ABeta42 levels to differentiate ADD from other subtypes of dementia. No studies of plasma ABeta42 met the inclusion criteria. No studies were rated as low risk of bias across all QUADAS-2 domains. High risk of bias was found predominantly in the domains of patient selection (28 studies) and index test (25 studies). The pooled estimates for differentiating ADD from other dementia subtypes were as follows: ADD from non-ADD: sensitivity 79% (95% CI 0.73 to 0.85), specificity 60% (95% CI 0.52 to 0.67), 13 studies, 1704 participants, 880 participants with ADD; ADD from VaD: sensitivity 79% (95% CI 0.75 to 0.83), specificity 69% (95% CI 0.55 to 0.81), 11 studies, 1151 participants, 941 participants with ADD; ADD from FTD: sensitivity 85% (95% CI 0.79 to 0.89), specificity 72% (95% CI 0.55 to 0.84), 17 studies, 1948 participants, 1371 participants with ADD; ADD from DLB: sensitivity 76% (95% CI 0.69 to 0.82), specificity 67% (95% CI 0.52 to 0.79), nine studies, 1929 participants, 1521 participants with ADD. Across all dementia subtypes, sensitivity was greater than specificity, and the balance of sensitivity and specificity was dependent on the threshold used to define test positivity. AUTHORS' CONCLUSIONS: Our review indicates that measuring ABeta42 levels in CSF may help differentiate ADD from other dementia subtypes, but the test is imperfect and tends to misdiagnose those with non-ADD as having ADD. We would caution against the use of CSF ABeta42 alone for dementia classification. However, ABeta42 may have value as an adjunct to a full clinical assessment, to aid dementia diagnosis.

Background: Thrombocytosis is associated with poor lung cancer prognosis and has recently been identified as having a high positive predictive value in lung cancer detection. Lung cancer has multiple histological and genetic subtypes and it is not known whether platelet levels differ across these subtypes, or whether thrombocytosis is predictive of a particular subtype. Methods: PubMed and Embase were systematically searched for studies that reported pre-treatment platelet count, as either averages or proportion of patients with thrombocytosis, by subtype of lung cancer using a prespecified search strategy. The Newcastle-Ottowa scale was used to assess study quality and risk of bias. Suitable studies were synthesised in meta-analyses and subgroup analyses examined for differences across subtypes. Results: the prevalence of pre-treatment thrombocytosis across all lung cancer patients was 27% (95% CI: 17% to 37%). By subtype, this was 22% (95% CI: 7% to 41%) for adenocarcinoma, 28% (95% CI: 15% to 43%) for squamous cell carcinoma (SCC), 36% (95% CI: 13% to 62%) for large cell carcinoma (LCC), and 30% (95% CI: 8% to 58%) for small cell lung cancer (SCLC). The pooled mean platelet count for lung cancer patients was 289×109/L (95% CI: 268 to 311). By subtype, this was 282×109/L (95% CI: 259 to 306) for adenocarcinoma, 297×109/L (95% CI: 238 to 356) for SCC, 290×109/L (95% CI: 176 to 404) for LCC, and 293×109/L (95% CI: 244 to 342) for SCLC. There was no difference in thrombocytosis prevalence (P=0.76) or mean platelet count (P=0.96) across the subtypes. Conclusions: These findings suggest thrombocytosis is no more indicative of one lung cancer subtype over another. We therefore conclude a high platelet count is likely to be generic across all lung cancer subtypes.

BACKGROUND: MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at https://doi.org/10.1186/s13063-017-1917-4 ). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale. METHODS: Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up. DISCUSSION: These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design. TRIAL REGISTRATION: International Standard Randomised Controlled Trials ISRCTN86619085. Registered on 3 June 2016.

BACKGROUND: Missed hospital outpatient appointments is a commonly reported problem in healthcare services around the world; for example, they cost the National Health Service (NHS) in the UK millions of pounds every year and can cause operation and scheduling difficulties worldwide. In 2002, the World Health Organization (WHO) published a report highlighting the need for a model of care that more readily meets the needs of people with chronic conditions. Patient-initiated appointment systems may be able to meet this need at the same time as improving the efficiency of hospital appointments. OBJECTIVES: to assess the effects of patient-initiated appointment systems compared with consultant-led appointment systems for people with chronic or recurrent conditions managed in secondary care. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and six other databases. We contacted authors of identified studies and conducted backwards and forwards citation searching. We searched for current/ongoing research in two trial registers. Searches were run on 13 March 2019. SELECTION CRITERIA: We included randomised trials, published and unpublished in any language that compared the use of patient-initiated appointment systems to consultant-led appointment systems for adults with chronic or recurrent conditions managed in secondary care if they reported one or more of the following outcomes: physical measures of health status or disease activity (including harms), quality of life, service utilisation or cost, adverse effects, patient or clinician satisfaction, or failures of the 'system'. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all references at title/abstract stage and full-text stage using prespecified inclusion criteria. We resolved disagreements though discussion. Two review authors independently completed data extraction for all included studies. We discussed and resolved discrepancies with a third review author. Where needed, we contacted authors of included papers to provide more information. Two review authors independently assessed the risk of bias using the Cochrane Effective Practice and Organisation of Care 'Risk of bias' tool, resolving any discrepancies with a third review author. Two review authors independently assessed the certainty of the evidence using GRADE. MAIN RESULTS: the 17 included randomised trials (3854 participants; mean age 41 to 76 years; follow-up 12 to 72 months) covered six broad health conditions: cancer, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, psoriasis and inflammatory bowel disease. The certainty of the evidence using GRADE ratings was mainly low to very low. The results suggest that patient-initiated clinics may make little or no difference to anxiety (odds ratio (OR) 0.87, 95% confidence interval (CI) 0.68 to 1.12; 5 studies, 1019 participants; low-certainty evidence) or depression (OR 0.79 95% CI 0.51 to 1.23; 6 studies, 1835 participants; low-certainty evidence) compared to the consultant-led appointment system. The results also suggest that patient-initiated clinics may make little or no difference to quality of life (standardised mean difference (SMD) 0.12, 95% CI 0.00 to 0.25; 7 studies, 1486 participants; low-certainty evidence) compared to the consultant-led appointment system. Results for service utilisation (contacts) suggest there may be little or no difference in service utilisation in terms of contacts between the patient-initiated and consultant-led appointment groups; however, the effect is not certain as the rate ratio ranged from 0.68 to 3.83 across the studies (median rate ratio 1.11, interquartile (IQR) 0.93 to 1.37; 15 studies, 3348 participants; low-certainty evidence). It is uncertain if service utilisation (costs) are reduced in the patient-initiated compared to the consultant-led appointment groups (8 studies, 2235 participants; very low-certainty evidence). The results suggest that adverse events such as relapses in some conditions (inflammatory bowel disease and cancer) may have little or no reduction in the patient-initiated appointment group in comparison with the consultant-led appointment group (MD -0.20, 95% CI -0.54 to 0.14; 3 studies, 888 participants; low-certainty evidence). The results are unclear about any differences the intervention may make to patient satisfaction (SMD 0.05, 95% CI -0.41 to 0.52; 2 studies, 375 participants) because the certainty of the evidence is low, as each study used different questions to collect their data at different time points and across different health conditions. Some areas of risk of bias across all the included studies was consistently high (i.e. for blinding of participants and personnel and blinding of outcome assessment, other areas were largely of low risk of bias or were affected by poor reporting making the assessment unclear). AUTHORS' CONCLUSIONS: Patient-initiated appointment systems may have little or no effect on patient anxiety, depression and quality of life compared to consultant-led appointment systems. Other aspects of disease status and experience also appear to show little or no difference between patient-initiated and consultant-led appointment systems. Patient-initiated appointment systems may have little or no effect on service utilisation in terms of service contact and there is uncertainty about costs compared to consultant-led appointment systems. Patient-initiated appointment systems may have little or no effect on adverse events such as relapse or patient satisfaction compared to consultant-led appointment systems.

AIMS: This study compared outcomes of surgical versus conservative management of ankle fractures in adults through a systematic review and meta-analysis. METHODS: We searched CINAHL, EMBASE, MEDLINE and CENTRAL databases (1946-June 2019) for randomised and quasi-randomised controlled trials comparing surgical versus conservative management of closed adult ankle fractures of any type. Estimates of effect were pooled using random effects meta-analysis. RESULTS: 1153 patients from 7 trials were included. Our primary outcome, ankle function score, was not statistically significantly different at 6-months (pooled mean difference (surgical minus conservative) = 1.0; 95% CI: -2.3 to 4.3; p = 0.55) or 12-months or more (pooled mean difference = 4.6; 95% CI: -1.0 to 10.2; p = 0.11) between surgical and conservative groups in three trials assessing displaced or unstable fractures, and two trials using non-validated questionnaires. One trial assessing AO-type-B1 fractures without talar shift had a statistically significant difference favouring conservative management, which was not clinically meaningful. Surgery had lower rates of early treatment failure and malunion/non-union, but higher rates of further surgery and infection. CONCLUSIONS: Surgical and conservative management of displaced or unstable ankle fractures produce similar short-term functional outcomes. The higher risk of early treatment failure and malunion/non-union in the conservative group versus higher rates of further surgery and infection in the surgical group should be considered. Trials are needed to assess longer-term results and inform management of select patient groups.

The study evaluated the implementation fidelity and effectiveness of KiVa, an evidence-based program that aims to prevent and address bullying in schools, with a particular emphasis on changing the role of bystanders. The study was a two-arm waitlist control cluster randomized controlled trial in which 22 primary schools (clusters) (N = 3214 students aged 7–11) were allocated using a 1:1 ratio to intervention (KiVa; 11 clusters, n = 1588 students) and a waitlist control (usual school provision; 11 clusters, n = 1892 children)). The trial statistician (but not schools or researchers) remained blind to allocation status. The outcomes were as follows: student-reported victimization (primary outcome) and bullying perpetration; teacher-reported child behavior and emotional well-being; and school absenteeism (administrative records). Implementation fidelity was measured using teacher-completed online records (for class lessons) and independent researcher observations (for school-wide elements). Outcome analyses involved 11 intervention schools (n = 1578 children) and 10 control schools (n = 1636 children). There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p = 0.11) or on the secondary outcomes. The impact on victimization was not moderated by child gender, age, or victimization status at baseline. Lesson adherence was good but exposure (lesson length) was lower than the recommended amount, and there was considerable variability in the implementation of whole school elements. The trial found insufficient evidence to conclude that KiVa had an effect on the primary outcome. A larger trial of KiVa in the UK is warranted, however, with attention to issues regarding implementation fidelity. Trial registration: Current Controlled Trials ISRCTN23999021 Date 10-6-13

Abstract
. Background
. Parent carers of disabled children are at increased risk of mental and physical health problems. They often experience challenges to maintaining good health which have implications for their well-being and their ability to care for their children. In response to these needs, researchers and parent carers developed the Healthy Parent Carers (HPC) programme. It is a peer-led, group-based intervention that promotes behaviours associated with health and well-being. The aims of this trial are to assess the acceptability of the HPC programme and the feasibility of its delivery in the community and to assess the feasibility and acceptability of the design of the definitive trial to evaluate the programme’s effectiveness and cost-effectiveness.
.
. Methods
. We will establish six research sites and train facilitators to deliver the manualised intervention. Parent carers of children with special educational needs and disabilities will be individually randomised, stratified by group delivery site, to either take part in a group programme and online resources (intervention) or to receive access to the online resources only (control). Measures of mental health; well-being; health-related quality of life; health behaviours; patient activation; protective factors such as resilience, social connections, and practical support; and use of health care, social care, and wider societal resources will be collected before randomisation (baseline), immediately post-intervention, and 6 months later. Recruitment of participants, adherence to the programme, and the dose received will be assessed. Group sessions will be audio-recorded to evaluate the fidelity of delivery and participant engagement. Participants’ and facilitators’ feedback on the programme content and delivery, their experience, and the acceptability of the outcome measures and trial design will be collected through feedback forms, interviews, and focus groups.
.
. Discussion
. This trial will assess whether the programme delivery and evaluative trial design are feasible, to inform whether to progress to a definitive randomised controlled trial to test the effectiveness and cost-effectiveness of the Healthy Parent Carers programme.
.
. Trial registration
. ISRCTN, ISRCTN151144652, registered on 25 October 2018; ClinicalTrials.gov, NCT03705221, registered on 15 October 2018.
.

Background: Anxiety may be associated with poor attendance at school, which can lead to a range of adverse outcomes. We systematically reviewed the evidence for an association between anxiety and poor school attendance. Methods: Seven electronic databases were searched for quantitative studies that reported an estimate of association between anxiety and school attendance. Anxiety had to be assessed via standardised diagnostic measure or validated scale. Articles were screened independently by two reviewers. Meta-analyses were performed where possible, otherwise results were synthesised narratively. Results: a total of 4930 articles were screened. Eleven studies from six countries across North America, Europe and Asia, were included. School attendance was categorised into: (a) absenteeism (i.e. total absences), (b) excused/medical absences, (c) unexcused absences/truancy and (d) school refusal. Findings from eight studies suggested associations between truancy and any anxiety disorder, as well as social and generalised anxiety. Results also suggested cross-sectional associations between school refusal and separation, generalised and social anxiety disorders, as well as simple phobia. Few studies investigated associations with absenteeism or excused/medical absences. Conclusions: Findings suggest associations between anxiety and unexcused absences/truancy, and school refusal. Clinicians should consider the possibility of anxiety in children and adolescents with poor attendance. However, there is a lack of high quality evidence, little longitudinal research and limited evidence relating to overall absenteeism or excused/medical absences, despite the latter being the most common type of absence. These gaps should be a key priority for future research.

Background
Teaching is a stressful occupation with poor retention. The Incredible Years® Teacher Classroom Management (TCM) programme is a training program that past research has demonstrated may be an effective intervention for children’s mental health, but little research has explored any impacts there may be on the teachers’ own professional confidence and mental health.
Aims
In this paper we evaluate whether TCM may lead to changes in teachers’ wellbeing, namely a reduction in burnout and an improvement in self-efficacy and mental health.
Sample
Eighty schools across the South West of England were recruited between September 2012 and September 2014. Headteachers were asked to nominate one class teacher to take part.
Methods
Eighty teachers were randomised to either attend a TCM course (intervention) or not (control). TCM was delivered to groups of up to twelve teachers in six whole-day workshops that were evenly spread between October and April. At baseline and nine months follow-up we measured teachers’ mental health using the Everyday Feelings Questionnaire (EFQ), burnout using the Maslach Burnout Inventory-General Survey (MBI-GS) and self-efficacy using the Teachers’ Sense of Efficacy Scale-Short (TSES-Short).
Results
Using linear regression models there was little evidence of differences at follow-up between the intervention and control teachers on the outcomes (the smallest p-value was 0.09).
Conclusions
Our findings did not replicate previous research that TCM improved teachers’ sense of efficacy. However, there were limitations with this study including low sample size.

BACKGROUND: Around 17% of people attending UK cardiac rehabilitation programmes have depression. Optimising psychological wellbeing is a rehabilitation goal, but provision of psychological care is limited. We developed and piloted an Enhanced Psychological Care (EPC) intervention embedded within cardiac rehabilitation, aiming to test key areas of uncertainty to inform the design of a definitive randomised controlled trial (RCT) and economic evaluation. METHODS: an external pilot randomised controlled trial (RCT) randomised eight cardiac rehabilitation teams (clusters) to either usual care of cardiac rehabilitation provision (UC), or EPC in addition to UC. EPC comprised mental health care coordination and patient-led behavioural activation with nurse support. Adults eligible for cardiac rehabilitation following an acute coronary syndrome and identified with new-onset depressive symptoms during an initial nurse assessment were eligible. Measures were performed at baseline and 5- and 8-month follow-ups and compared between EPC and UC. Team and participant recruitment and retention rates, and participant outcomes (clinical events, depression, anxiety, health-related quality of life, patient experiences, and resource use) were assessed. RESULTS: Eight out of twenty teams were recruited and randomised. of 614 patients screened, 55 were eligible and 29 took part (5%, 95% CI 3 to 7% of those screened), with 15 patient participants cluster randomised to EPC and 14 to UC. Nurse records revealed that 8/15 participants received the maximum number of EPC sessions offered; and 4/15 received no sessions. Seven out of fifteen EPC participants were referred to another NHS psychological service compared to none in UC. We followed up 27/29 participants at 5 months and 17/21 at 8 months. The mean difference (EPC minus UC) in depressive symptoms (Beck Depression Inventory) at follow-up (adjusting for baseline score) was 1.7 (95% CI - 3.8 to 7.3; N = 26) at 5 months and 4.4 (95% CI - 1.4 to 10.2; N = 17) at 8 months. DISCUSSION: While valued by patients and nurses, organisational and workload constraints are significant barriers to EPC implementation. There remains a need to develop and test new models of psychological care within cardiac rehabilitation. Our study offers important data to inform the design of future trials of similar interventions. TRIAL REGISTRATION: ISRCTN34701576. Registered on 29 May 2014. Funding details: UK NIHR HTA Programme (project 12/189/09).

BACKGROUND: in a community sample of slow-to-talk toddlers, we aimed to (a) quantify how well maternal responsive behaviors at age 2 years predict language ability at age 4 and (b) examine whether maternal responsive behaviors more accurately predict low language status at age 4 than does expressive vocabulary measured at age 2 years. DESIGN OR METHODS: Prospective community-based longitudinal study. At child age 18 months, 1,138 parents completed a 100-word expressive vocabulary checklist within a population survey; 251 (22.1%) children scored ≤20th percentile and were eligible for the current study. Potential predictors at 2 years were (a) responsive language behaviors derived from videotaped parent-child free-play samples and (b) late-talker status. Outcomes were (a) Clinical Evaluation of Language Fundamentals-Preschool Second Edition receptive and expressive language standard score at 4 years and (b) low language status (standard score > 1.25 standard deviations below the mean on expressive or receptive language). RESULTS: Two hundred eight (82.9% of 251) participants were retained to age 4. In adjusted linear regression analyses, maternal expansions predicted higher receptive (p 

BACKGROUND: Around 19% of people screened by UK cardiac rehabilitation programmes report having moderate or severe symptoms of depression. These individuals are at an increased risk of cardiac mortality and morbidity, reduced quality of life and increased use of health resources compared with their non-depressed counterparts. Maximising psychological health is a goal of cardiac rehabilitation, but psychological care is patchy. OBJECTIVE(S): to examine the feasibility and acceptability of embedding enhanced psychological care (EPC) within cardiac rehabilitation, we tested the feasibility of developing/implementing EPC and documented the key uncertainties associated with undertaking a definitive evaluation. DESIGN: a two-stage multimethods study; a feasibility study and a qualitative evaluation, followed by an external pilot cluster randomised controlled trial (RCT) with a nested qualitative study. SETTING: UK comprehensive cardiac rehabilitation teams. PARTICIPANTS: Adults eligible for cardiac rehabilitation following an acute coronary syndrome with new-onset depressive symptoms on initial nurse assessment. Patients who had received treatment for depression in the preceding 6 months were excluded. INTERVENTIONS: the EPC intervention comprised nurse-led mental health-care co-ordination and behavioural activation within cardiac rehabilitation. The comparator was usual cardiac rehabilitation care. MAIN OUTCOME MEASURES: Measures at baseline, and at the 5- (feasibility and pilot) and 8-month follow-ups (pilot only). Process measures related to cardiac team and patient recruitment, and participant retention. Outcomes included depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Interviews explored participant and nurses' views and experiences. RESULTS: Between September 2014 and May 2015, five nurses from four teams recruited participants into the feasibility study. of the 203 patients screened, 30 were eligible and nine took part (the target was 20 participants). At interview, participants and nurses gave valuable insights into the EPC intervention design and delivery. Although acceptable, the EPC delivery was challenging for nurses (e.g. the ability to allocate sufficient time within existing workloads) and the intervention was modified accordingly. Between December 2014 and February 2015, 8 out of 20 teams approached agreed to participate in the pilot RCT [five were randomised to the EPC arm and three were randomised to the usual-care (UC) arm]. of the 614 patients screened, 55 were eligible and 29 took part (the target was 43 participants). At baseline, the trial arms were well matched for sex and ethnicity, although the EPC arm participants were younger, from more deprived areas and had higher depression scores than the UC participants. A total of 27 out of 29 participants were followed up at 5 months. Interviews with 18 participants (12 in the EPC arm and six in the UC arm) and seven nurses who delivered EPC identified that both groups acknowledged the importance of receiving psychological support embedded within routine cardiac rehabilitation. For those experiencing/delivering EPC, the intervention was broadly acceptable, albeit challenging to deliver within existing care. LIMITATIONS: Both the feasibility and the pilot studies encountered significant challenges in recruiting patients, which limited the power of the pilot study analyses. CONCLUSIONS: Cardiac rehabilitation nurses can be trained to deliver EPC. Although valued by both patients and nurses, organisational and workload constraints were significant barriers to implementation in participating teams, suggesting that future research may require a modified approach to intervention delivery within current service arrangements. We obtained important data informing definitive research regarding participant recruitment and retention, and optimal methods of data collection. FUTURE RESEARCH: Consideration should be given to the delivery of EPC by dedicated mental health practitioners, working closely with cardiac rehabilitation services. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34701576. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 30. See the NIHR Journals Library website for further project information.

BACKGROUND: Antibiotic-resistant bacteria (ARB) present a global public health problem. With numbers of community-acquired resistant infections increasing, understanding the mechanisms by which people are exposed to and colonised by ARB can help inform effective strategies to prevent their spread. The role natural environments play in this is poorly understood. This is the first study to combine surveillance of ARB in bathing waters, human exposure estimates and association between exposure and colonisation by ARB in water users. METHODS: 97 bathing water samples from England and Wales were analysed for the proportion of E. coli harbouring blaCTX-M. These data were used to estimate the likelihood of water users ingesting blaCTX-M-bearing E. coli. Having identified surfers as being at risk of exposure to ARB, a cross-sectional study was conducted. Regular surfers and non-surfers were recruited to assess whether there is an association between surfing and gut colonisation by blaCTX-M-bearing E. coli. RESULTS: 11 of 97 bathing waters sampled were found to contain blaCTX-M-bearing E. coli. While the percentage of blaCTX-M-bearing E. coli in bathing waters was low (0.07%), water users are at risk of ingesting these ARB. It is estimated that over 2.5 million water sports sessions occurred in 2015 resulting in the ingestion of at least one blaCTX-M-bearing E. coli. In the epidemiological survey, 9/143 (6.3%) surfers were colonised by blaCTX-M-bearing E. coli, as compared to 2/130 (1.5%) of non-surfers (risk ratio=4.09, 95% CI 1.02 to 16.4, p=0.046). CONCLUSIONS: Surfers are at risk of exposure to and colonisation by clinically important antibiotic-resistant E. coli in coastal waters. Further research must be done on the role natural environments play in the transmission of ARB.

BACKGROUND: Numerous illnesses are associated with bathing in natural waters, although it is assumed that the risk of illness among bathers exposed to relatively clean waters found in high-income countries is negligible. A systematic review was carried out to quantify the increased risk of experiencing a range of adverse health outcomes among bathers exposed to coastal water compared with non-bathers. METHODS: in all 6919 potentially relevant titles and abstracts were screened, and from these 40 studies were eligible for inclusion in the review. Odds ratios (OR) were extracted from 19 of these reports and combined in random-effect meta-analyses for the following adverse health outcomes: incident cases of any illness, ear infections, gastrointestinal illness and infections caused by specific microorganisms. RESULTS: There is an increased risk of experiencing symptoms of any illness [OR = 1.86, 95% confidence interval (CI): 1.31 to 2.64, P = 0.001] and ear ailments (OR = 2.05, 95% CI: 1.49 to 2.82, P < 0.001) in bathers compared with non-bathers. There is also an increased risk of experiencing gastrointestinal ailments (OR = 1.29, 95% CI: 1.12 to 1.49, P < 0.001). CONCLUSIONS: This is the first systematic review to evaluate evidence on the increased risk of acquiring illnesses from bathing in seawater compared with non-bathers. Our results support the notion that infections are acquired from bathing in coastal waters, and that bathers have a greater risk of experiencing a variety of illnesses compared with non-bathers.

Stroke is an established risk factor for all-cause dementia, though meta-analyses are needed to quantify this risk. We searched Medline, PsycINFO, and Embase for studies assessing prevalent or incident stroke versus a no-stroke comparison group and the risk of all-cause dementia. Random effects meta-analysis was used to pool adjusted estimates across studies, and meta-regression was used to investigate potential effect modifiers. We identified 36 studies of prevalent stroke (1.9 million participants) and 12 studies of incident stroke (1.3 million participants). For prevalent stroke, the pooled hazard ratio for all-cause dementia was 1.69 (95% confidence interval: 1.49-1.92; P <. 00001; I2 = 87%). For incident stroke, the pooled risk ratio was 2.18 (95% confidence interval: 1.90-2.50; P <. 00001; I2 = 88%). Study characteristics did not modify these associations, with the exception of sex which explained 50.2% of between-study heterogeneity for prevalent stroke. Stroke is a strong, independent, and potentially modifiable risk factor for all-cause dementia.

Background
Depression in young people may lead to reduced school attendance through social withdrawal, loss of motivation, sleep disturbance and low energy. We systematically reviewed the evidence for an association between depression and poor school attendance.

Methods
Seven electronic databases were searched for quantitative studies with school-aged children and/or adolescents, reporting a measure of association between depression and school attendance. Articles were independently screened by two reviewers. Synthesis incorporated random-effects meta-analysis and narrative synthesis.

Results
Searches identified 4930 articles. Nineteen studies from eight countries across North America, Europe, and Asia, were included. School attendance was grouped into: 1) absenteeism (i.e. total absences), 2) excused/medical absences, 3) unexcused absences/truancy, and 4) school refusal. Meta-analyses demonstrated small-to-moderate positive cross-sectional associations between depression and absenteeism (correlation coefficient r=0.11, 95% confidence interval 0.07 to 0.15, p=0.005, I2= 63%); and depression and unexcused absences/truancy (r=0.15, 95% confidence interval 0.13 to 0.17, p

Abstract
Background. We evaluated the effectiveness and cost-effectiveness of the Incredible Years® Teacher Classroom Management (TCM) programme as a universal intervention, given schools’ important influence on child mental health.
Methods. A two-arm, pragmatic, parallel group, superiority, cluster randomised controlled trial recruited three cohorts of schools (clusters) between 2012 and 2014, randomising them to TCM (intervention) or Teaching As Usual (TAU-control). TCM was delivered to teachers
in six whole-day sessions, spread over 6 months. Schools and teachers were not masked to allocation. The primary outcome was teacher-reported Strengths and Difficulties Questionnaire (SDQ) Total Difficulties score. Random effects linear regression and marginal logistic regression models using Generalised Estimating Equations were used to analyse the
outcomes. Trial registration: ISRCTN84130388.
Results. Eighty schools (2075 children) were enrolled; 40 (1037 children) to TCM and 40 (1038 children) to TAU. Outcome data were collected at 9, 18, and 30-months for 96, 89, and 85% of children, respectively. The intervention reduced the SDQ-Total Difficulties score at 9 months (mean (S.D.):5.5 (5.4) in TCM v. 6.2 (6.2) in TAU; adjusted mean difference
= −1.0; 95% CI−1.9 to −0.1; p = 0.03) but this did not persist at 18 or 30 months. Cost-effectiveness analysis suggested that TCM may be cost-effective compared with TAU at 30-months, but this result was associated with uncertainty so no firm conclusions can be drawn. A priori
subgroup analyses suggested TCM is more effective for children with poor mental health.
Conclusions. TCM provided a small, short-term improvement to children’s mental health particularly for children who are already struggling.

This paper assesses the reliability and validity of the teacher-completed Pupil Behaviour Questionnaire (PBQ), by comparing it to the already extensively validated teacher-completed Strengths and Difficulties Questionnaire (SDQ). Participants included 2074 primary school children participating in a universal school-based trial and 41 vulnerable children who were taking part in a study exploring the impact of exclusion from school. Exploratory factor analysis results (first factor accounts for 80.8% of the variation in the items) and the high Cronbach’s alpha value of 0.85 indicate that the PBQ consists of one substantive factor/dimension. Strong correlations between the total PBQ score and the conduct sub-scale (Spearman’s correlation coefficient (rs) = 0.67) and total difficulties score (rs = 0.59) of the SDQ indicate convergent validity. This study suggests that the PBQ is a reliable measure, and provides some evidence of validity. Further work is needed to test the PBQ in an older, more diverse populations and to measure sensitivity to change.

OBJECTIVE: to test the feasibility of running a randomised controlled trial of a preconsultation web-based intervention (Presenting Asking Checking Expressing (PACE-D)) to improve the quality of care and clinical outcomes in patients with diabetes. DESIGN AND SETTING: a feasibility study (with randomisation) conducted at outpatient diabetes clinics at two secondary care hospitals in Devon, UK. PARTICIPANTS: People with diabetes (type 1 and type 2) attending secondary care general diabetes outpatient clinics. INTERVENTION: the PACE-D, a web-based tool adapted for patients with diabetes to use before their consultation to generate an agenda of topics to discuss with their diabetologist. OUTCOMES: the percentage of eligible patients who were recruited and the percentage of participants for whom routine glycosylated haemoglobin (HbA1c) data (the putative primary outcome) could be extracted from medical notes and who completed secondary outcome assessments via questionnaire at follow-up were reported. RESULTS: in contrast with the planned recruitment of 120 participants, only 71 participants were randomised during the 7-month recruitment period. This comprised 18.7% (95% CI 14.9% to 23.0%) of those who were eligible. Mean (SD) age of the participants was 56.5 (12.4) years and 66.2% had type 1 diabetes. Thirty-eight patients were randomised to the intervention arm and 33 to the control arm. HbA1c data were available for only 73% (95% CI 61% to 83%) of participants at the 6�
months follow-up. The questionnaire-based data were collected for 66% (95% CI 54% to 77%) of the participants at 6�
months follow-up. Participants reported that the PACE-D tool was easy to use. CONCLUSIONS: a randomised controlled trial of the preconsultation web-based intervention as set out in our current protocol is not feasible without significant modification to improve recruitment and follow-up of participants. The study also provides insights into the feasibility and challenges of conducting complex intervention trials in everyday clinical practice. TRIAL REGISTRATION: ISRCTN75070242.

BACKGROUND: Thrombocytosis (raised platelet count) is an emerging risk marker of cancer, but the association has not been fully explored in a primary care context. AIM: to examine the incidence of cancer in a cohort of patients with thrombocytosis, to determine how clinically useful this risk marker could be in predicting an underlying malignancy. DESIGN AND SETTING: a prospective cohort study using Clinical Practice Research Datalink data from 2000 to 2013. METHOD: the 1-year incidence of cancer was compared between two cohorts: 40 000 patients aged ≥40 years with a platelet count of >400 × 109/L (thrombocytosis) and 10 000 matched patients with a normal platelet count. Sub-analyses examined the risk with change in platelet count, sex, age, and different cancer sites. RESULTS: a total of 1098 out of 9435 males with thrombocytosis were diagnosed with cancer (11.6%; 95% confidence interval [CI] = 11.0 to 12.3), compared with 106 of 2599 males without thrombocytosis (4.1%; 95% CI = 3.4 to 4.9). A total of 1355 out of 21 826 females with thrombocytosis developed cancer (6.2%; 95% CI = 5.9 to 6.5), compared with 119 of 5370 females without (2.2%; 95% CI = 1.8 to 2.6). The risk of cancer increased to 18.1% (95% CI = 15.9 to 20.5) for males and 10.1% (95% CI = 9.0 to 11.3) for females, when a second raised platelet count was recorded within 6 months. Lung and colorectal cancer were more commonly diagnosed with thrombocytosis. One-third of patients with thrombocytosis and lung or colorectal cancer had no other symptoms indicative of malignancy. CONCLUSION: Thrombocytosis is a risk marker of cancer in adults; 11.6% and 6.2% cancer incidence in males and females, respectively, is worthy of further investigation for underlying malignancy. These figures well exceed the National Institute for Health and Care Excellence-mandated risk threshold of 3% risk to warrant referral for suspected cancer.

Introduction: the association between history of coronary artery bypass graft surgery (CABG) and dementia risk remains unclear. Methods: We conducted a prospective cohort analysis using data on 3155 elderly adults free from prevalent dementia from the US population-based Cardiovascular Health Study (CHS) with adjudicated incident all-cause dementia, Alzheimer disease (AD), vascular dementia (VaD), and mixed dementia. Results: in the CHS, the hazard ratio (HR) for all-cause dementia was 1.93 [95% confidence interval (CI), 1.36-2.74] for those with CABG history compared with those with no CABG history after adjustment for potential confounders. Similar HRs were observed for AD (HR=1.71; 95% CI, 0.98-2.98), VaD (HR=1.42; 95% CI, 0.56-3.65), and mixed dementia (HR=2.73; 95% CI, 1.55-4.80). The same pattern of results was observed when these CHS findings were pooled with a prior prospective study, the pooled HRs were 1.96 (95% CI, 1.42-2.69) for all-cause dementia, 1.71 (95% CI, 1.04-2.79) for AD and 2.20 (95% CI, 0.78-6.19) for VaD. Discussion: Our results suggest CABG history is associated with long-term dementia risk. Further investigation is warranted to examine the causal mechanisms which may explain this relationship or whether the association reflects differences in coronary artery disease severity.

BACKGROUND: a number of studies demonstrate that children who are younger within their school year have poorer academic attainment and are more likely to have special educational needs. Few, however, have considered the impact relative age may have on child mental health, behaviour and happiness in school. METHODS: This paper utilized data from the Supporting Teachers and Children in Schools study (2075 pupils aged 5 to 9 years from 80 primary schools) to explore the relationship among relative age, behaviour and happiness in school. Behavioural and emotional development was assessed by using the teacher-reported and parent-reported Strengths and Difficulties Questionnaire and the Pupil Behaviour Questionnaire. Children's happiness within school was assessed by using the How I Feel About My School Questionnaire. RESULTS: Relatively younger children had higher Total Difficulties scores on the Strengths and Difficulties Questionnaire than their peers. There was a mean increase per 30-day decrease in relative age of 0.09 (95% CI: 0.03 to 0.16; p = 0.007) in teacher-reported and 0.08 (0.001 to 0.16; p = 0.05) in parent-reported scores. There was little evidence of a relationship between relative age and children's behaviour and happiness in school. CONCLUSIONS: for children with complex difficulties, being relatively young for their school year may be an additional stressor that may undermine mental health.

UNLABELLED: This study evaluated the effectiveness of a group parenting intervention designed to strengthen the home learning environment of children from disadvantaged families. Two cluster randomised controlled superiority trials were conducted in parallel and delivered within existing services: a 6-week parenting group (51 locations randomised; 986 parents) for parents of infants (aged 6-12 months), and a 10-week facilitated playgroup (58 locations randomised; 1200 parents) for parents of toddlers (aged 12-36 months). Each trial had three conditions: intervention (smalltalk group-only); enhanced intervention with home coaching (smalltalk plus); and 'standard'/usual practice controls. Parent-report and observational measures were collected at baseline, 12 and 32 weeks follow-up. Primary outcomes were parent verbal responsivity and home learning activities at 32 weeks. In the infant trial, there were no differences by trial arm for the primary outcomes at 32 weeks. In the toddler trial at 32-weeks, participants in the smalltalk group-only trial showed improvement compared to the standard program for parent verbal responsivity (effect size (ES) = 0.16; 95% CI 0.01, 0.36) and home learning activities (ES = 0.17; 95% CI 0.01, 0.38) but smalltalk plus did not. For the secondary outcomes in the infant trial, several initial differences favouring smalltalk plus were evident at 12 weeks, but not maintained to 32 weeks. For the toddler trial, differences in secondary outcomes favouring smalltalk plus were evident at 12 weeks and maintained to 32 weeks. These trials provide some evidence of the benefits of a parenting intervention focused on the home learning environment for parents of toddlers but not infants. TRIAL REGISTRATION: 8 September 2011; ACTRN12611000965909.

BACKGROUND: Guidelines and evidence-based drug treatment recommendations are usually based on the results of clinical trials, which have limited generalisability in routine clinical settings due to their restrictive eligibility criteria. These trials are also conducted in ideal and rigorously controlled settings. N of 1 trials, which are single patient multiple crossover studies, offer a means of increasing the evidence base and individualising care for individuals in clinical practice. This systematic review of the N of 1 drug treatment trial aims to investigate its usefulness for achieving optimal individualised patient care. METHODS: the following databases will be searched for relevant articles: MEDLINE, EMBASE, PsycINFO (all via Ovid), AMED, CINAHAL (via EBSCO), the Cochrane Library (including CENTRAL, NHS EED, and DARE), and Web of Science (Thomson Reuters). Supplementary searches will include ongoing trial databases and organisational websites. All N of 1 trials in which patients have been treated with a drug will be considered. Outcomes will include information on the clinical usefulness of N of 1 trials-i.e. achievement of optimal individualised care, health-care utilisation of patients, frequently used practices, experiences of clinical care or participation in N of 1 trials, adherence to treatment plan, and unwanted effects of the treatment. Screening of included papers will be undertaken independently by two reviewers, while data extraction and the quality of reporting will be conducted by one reviewer and checked by another. Both quantitative and qualitative summaries will be reported using appropriate methods. DISCUSSION: This review will provide new insights into the clinical utility of N of 1 drug trials in helping participants find the most acceptable treatment as defined by patients and clinicians based on the selected outcome measures and the perspectives of participants involved in such trials. Findings from this review will inform the development of a stakeholder workshop and guidance to help physicians find the optimum therapy for their patients and will help guide future research on N of 1 trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016032452.

BACKGROUND: Anxiety and depression are common in young people and are associated with a range of adverse outcomes. Research has suggested a relationship between emotional disorder and poor school attendance, and thus poor attendance may serve as a red flag for children at risk of emotional disorder. This systematic review aims to investigate the association between child and adolescent emotional disorder and poor attendance at school. METHODS: We will search electronic databases from a variety of disciplines including medicine, psychology, education and social sciences, as well as sources of grey literature, to identify any quantitative studies that investigate the relationship between emotional disorder and school attendance. Emotional disorder may refer to diagnoses of mood or anxiety disorders using standardised diagnostic measures, or measures of depression, anxiety or "internalising symptoms" using a continuous scale. Definitions for school non-attendance vary, and we aim to include any relevant terminology, including attendance, non-attendance, school refusal, school phobia, absenteeism and truancy. Two independent reviewers will screen identified papers and extract data from included studies. We will assess the risk of bias of included studies using the Newcastle-Ottawa Scale. Random effects meta-analysis will be used to pool quantitative findings when studies use the same measure of association, otherwise a narrative synthesis approach will be used. DISCUSSION: This systematic review will provide a detailed synthesis of evidence regarding the relationship between childhood emotional disorder and poor attendance at school. Understanding this relationship has the potential to assist in the development of strategies to improve the identification of and intervention for this vulnerable group. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016052961.

BACKGROUND: Mindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness or cost-effectiveness for young people. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of a mindfulness training (MT) programme to enhance mental health, wellbeing and social-emotional behavioural functioning in adolescence. METHODS/DESIGN: to address this aim, the design will be a superiority, cluster randomised controlled, parallel-group trial in which schools offering social and emotional provision in line with good practice (Formby et al. Personal, Social, Health and Economic (PSHE) Education: a mapping study of the prevalent models of delivery and their effectiveness, 2010; OFSTED, Not Yet Good Enough: Personal, Social, Health and Economic Education in schools, 2013) will be randomised to either continue this provision (control) or include MT in this provision (intervention). The study will recruit and randomise 76 schools (clusters) and 5700 school students aged 12 to 14 years, followed up for 2 years. DISCUSSION: the study will contribute to establishing if MT is an effective and cost-effective approach to promoting mental health in adolescence. TRIALS REGISTRATION: International Standard Randomised Controlled Trials, identifier: ISRCTN86619085. Registered on 3 June 2016.

BACKGROUND: Interventions aiming to coordinate services for the community-based dementia population vary in components, organisation and implementation. In this review we aimed to evaluate the effectiveness of community-based care coordinating interventions on health outcomes and investigate whether specific components of interventions influence their effects. METHODS: We searched four databases from inception to April 2017: Medline, the Cochrane Library, EMBASE and PsycINFO. This was aided by a search of four grey literature databases, and backward and forward citation tracking of included papers. Title and abstract screening was followed by a full text screen by two independent reviewers, and quality was assessed using the CASP appraisal tool. We then conducted meta-analyses and subgroup analyses. RESULTS: a total of 14 randomised controlled trials (RCTs) involving 10,372 participants were included in the review. Altogether we carried out 12 meta-analyses and 19 subgroup analyses. Meta-analyses found coordinating interventions showed a statistically significant improvement in both patient behaviour measured using the Neuropsychiatric Inventory (NPI) (mean difference (MD) = -9.5; 95% confidence interval (CI): -18.1 to -1.0; p = 0.03; number of studies (n) = 4; I2 = 88%) and caregiver burden (standardised mean difference (SMD) = -0.54; 95% CI: -1.01 to -0.07; p = 0.02; n = 5, I2 = 92%) compared to the control group. Subgroup analyses found interventions using a case manager with a nursing background showed a greater positive effect on caregiver quality of life than those that used case managers from other professional backgrounds (SMD = 0.94 versus 0.03, respectively; p 

BACKGROUND: Identification of permanent hearing impairment at the earliest possible age is crucial to maximise the development of speech and language. Universal newborn hearing screening identifies the majority of the 1 in 1000 children born with a hearing impairment, but later onset can occur at any time and there is no optimum time for further screening. A universal but non-standardised school entry screening (SES) programme is in place in many parts of the UK but its value is questioned. OBJECTIVES: to evaluate the diagnostic accuracy of hearing screening tests and the cost-effectiveness of the SES programme in the UK. DESIGN: Systematic review, case-control diagnostic accuracy study, comparison of routinely collected data for services with and without a SES programme, parental questionnaires, observation of practical implementation and cost-effectiveness modelling. SETTING: Second- and third-tier audiology services; community. PARTICIPANTS: Children aged 4-6 years and their parents. MAIN OUTCOME MEASURES: Diagnostic accuracy of two hearing screening devices, referral rate and source, yield, age at referral and cost per quality-adjusted life-year. RESULTS: the review of diagnostic accuracy studies concluded that research to date demonstrates marked variability in the design, methodological quality and results. The pure-tone screen (PTS) (Amplivox, Eynsham, UK) and HearCheck (HC) screener (Siemens, Frimley, UK) devices had high sensitivity (PTS ≥ 89%, HC ≥ 83%) and specificity (PTS ≥ 78%, HC ≥ 83%) for identifying hearing impairment. The rate of referral for hearing problems was 36% lower with SES (Nottingham) relative to no SES (Cambridge) [rate ratio 0.64, 95% confidence interval (CI) 0.59 to 0.69; p 

UNLABELLED: Significant increased hip fracture incidence has been reported in the year following total knee replacement. This study demonstrates that bone and muscle loss is a post-surgical consequence of total knee replacement, alongside poor outcomes in function and activity potentially contributing to reduced quality of life and increased hip fracture risk. INTRODUCTION: a significant increase in hip fracture incidence in the year following total knee replacement (TKR) surgery has been reported. This study investigated function and activity following TKR and the effects of limited mobility on bone and muscle loss and their potential contribution to hip fracture risk. METHODS: Changes in dual-energy X-ray absorptiometry (DXA) (GE Lunar Prodigy, Bedford MA), bone mineral density (BMD) at the neck of femur (NOF), total hip region (TH) and lumbar spine were measured alongside leg lean tissue mass (LLTM) in post-menopausal Caucasian females following TKR (N = 19) compared to controls (N = 43). Lumbar spine trabecular bone scores (TBSs) were calculated. Ipsilateral/contralateral weight bearing, lower limb function, 3-day pedometer readings, pain levels and falls were also recorded. Measurements were obtained at pre-surgery baseline and at 6 weeks, 6 months and 12 months post-surgery. RESULTS: No statistically significant differences were demonstrated between groups at baseline bilaterally in LLTM or BMD at the NOF and TH. Losses in ipsilateral NOF and TH BMD and contralateral LLTM were significantly higher in the TKR group at 6 months. Impairment in function and weight bearing persisted in the TKR group 12 months post-operatively alongside deficits in bilateral muscle mass and ipsilateral NOF and TH BMD. Falls incidence was not significantly higher in the TKR group. CONCLUSIONS: Bone loss at the hip with associated muscle loss is a consequence of TKR that, in addition to poor patient outcomes in function and activity, potentially contributes to increased hip fracture risk in the year following surgery.

BACKGROUND: Around 17% of people eligible for UK cardiac rehabilitation programmes following an acute coronary syndrome report moderate or severe depressive symptoms. While maximising psychological health is a core goal of cardiac rehabilitation, psychological care can be fragmented and patchy. This study tests the feasibility and acceptability of embedding enhanced psychological care, composed of two management strategies of proven effectiveness in other settings (nurse-led mental health care coordination and behavioural activation), within the cardiac rehabilitation care pathway. METHODS/DESIGN: This study tests the uncertainties associated with a large-scale evaluation by conducting an external pilot trial with a nested qualitative study. We aim to recruit and randomise eight comprehensive cardiac rehabilitation teams (clusters) to intervention (embedding enhanced psychological care into routine cardiac rehabilitation programmes) or control (routine cardiac rehabilitation programmes alone) arms. Up to 64 patients (eight per team) identified with depressive symptoms upon initial assessment by the cardiac rehabilitation team will be recruited, and study measures will be administered at baseline (before starting rehabilitation) and at 5 months and 8 months post baseline. Outcomes include depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Trial data on cardiac team and patient recruitment, and the retention and flow of patients through treatment will be used to assess intervention feasibility and acceptability. Qualitative interviews will be undertaken to explore trial participants' and cardiac rehabilitation nurses' views and experiences of the trial methods and intervention, and to identify reasons why patients declined to take part in the trial. Outcome data will inform a sample size calculation for a definitive trial. DISCUSSION: the pilot trial and qualitative study will inform the design of a fully powered cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the provision of enhanced psychological care within cardiac rehabilitation programmes. TRIAL REGISTRATION: ISRCTN34701576 (Registered 29 May 2014).

PURPOSE: to explore the association between children's self-reported contact with people with disabilities and attitudes towards them, as well the potential mediating influence of anxiety about interacting with people with disabilities and empathy for them. METHOD: 1881 children, aged 7-16 years, from 20 schools in South West England completed a survey assessing their contact with people with disabilities and their attitudes towards them. Anxiety about interacting with people with disabilities and empathy towards them were examined as potential mediators. Gender, school year, perceived similarity between people with and without disabilities, proportion of children with additional needs at the school and socioeconomic status (SES) were assessed as moderators. A random effects ("multilevel") regression model was used to test the contact-attitude association and moderation, and path analysis was used to test for mediation. RESULTS: Participants with more self-reported contact reported more positive attitudes towards disability (p 

AIM: to assess the diagnostic accuracy of computed tomography coronary angiography (CTCA) using a combination of high-definition CT (HD-CTCA) and high level of reader experience, with invasive coronary angiography (ICA) as the reference standard, in high-risk patients for the investigation of coronary artery disease (CAD). MATERIALS AND METHODS: Three hundred high-risk patients underwent HD-CTCA and ICA. Independent experts evaluated the images for the presence of significant CAD, defined primarily as the presence of moderate (≥ 50%) stenosis and secondarily as the presence of severe (≥ 70%) stenosis in at least one coronary segment, in a blinded fashion. HD-CTCA was compared to ICA as the reference standard. RESULTS: No patients were excluded. Two hundred and six patients (69%) had moderate and 178 (59%) had severe stenosis in at least one vessel at ICA. The sensitivity, specificity, positive predictive value, and negative predictive value were 97.1%, 97.9%, 99% and 93.9% for moderate stenosis, and 98.9%, 93.4%, 95.7% and 98.3%, for severe stenosis, on a per-patient basis. CONCLUSION: the combination of HD-CTCA and experienced readers applied to a high-risk population, results in high diagnostic accuracy comparable to ICA. Modern generation CT systems in experienced hands might be considered for an expanded role.

BACKGROUND: Bullying refers to verbal, physical or psychological aggression repeated over time that is intended to cause harm or distress to the victims who are unable to defend themselves. It is a key public health priority owing to its widespread prevalence in schools and harmful short- and long-term effects on victims' well-being. There is a need to strengthen the evidence base by testing innovative approaches to preventing bullying. KiVa is a school-based bullying prevention programme with universal and indicated elements and an emphasis on changing bystander behaviour. It achieved promising results in a large trial in Finland, and now requires testing in other countries. This paper describes the protocol for a cluster randomised controlled trial (RCT) of KiVa in Wales. METHODS/DESIGN: the study uses a two-arm waitlist control pragmatic definitive parallel group cluster RCT design with an embedded process evaluation and calculation of unit cost. Participating schools will be randomised a using a 1:1 ratio to KiVa plus usual provision (intervention group) or usual provision only (control group). The trial has one primary outcome, child self-reported victimisation from bullying, dichotomised as 'victimised' (bullied at least twice a month in the last couple of months) versus 'not victimised'. Secondary outcomes are: bullying perpetration; aspects of child social and emotional well-being (including emotional problems, conduct, peer relations, prosocial behaviour); and school attendance. Follow-up is at 12 months post-baseline. Implementation fidelity is measured through teacher-completed lesson records and independent school-wide observation. A micro-costing analysis will determine the costs of implementing KiVa, including recurrent and non-recurrent unit costs. Factors related to the scalability of the programme will be examined in interviews with head teachers and focus groups with key stakeholders in the implementation of school-based bullying interventions. DISCUSSION: the results from this trial will provide evidence on whether the KiVa programme is transportable from Finland to Wales in terms of effectiveness and implementation. It will provide information about the costs of delivery and generate insights into factors related to the scalability of the programme. TRIAL REGISTRATION: Current Controlled Trials ISRCTN23999021 Date 10-6-13.

BACKGROUND: the quality of the home learning environment has a significant influence on children's language and communication skills during the early years with children from disadvantaged families disproportionately affected. This paper describes the protocol and participant baseline characteristics of a community-based effectiveness study. It evaluates the effects of 'smalltalk', a brief group parenting intervention (with or without home coaching) on the quality of the early childhood home learning environment. METHODS/DESIGN: the study comprises two cluster randomised controlled superiority trials (one for infants and one for toddlers) designed and conducted in parallel. In 20 local government areas (LGAs) in Victoria, Australia, six locations (clusters) were randomised to one of three conditions: standard care (control); smalltalk group-only program; or smalltalk plus (group program plus home coaching). Programs were delivered to parents experiencing socioeconomic disadvantage through two existing age-based services, the maternal and child health service (infant program, ages 6-12 months), and facilitated playgroups (toddler program, ages 12-36 months). Outcomes were assessed by parent report and direct observation at baseline (0 weeks), post-intervention (12 weeks) and follow-up (32 weeks). Primary outcomes were parent verbal responsivity and home activities with child at 32 weeks. Secondary outcomes included parenting confidence, parent wellbeing and children's communication, socio-emotional and general development skills. Analyses will use intention-to-treat random effects ("multilevel") models to account for clustering. RECRUITMENT AND BASELINE DATA: Across the 20 LGAs, 986 parents of infants and 1200 parents of toddlers enrolled and completed baseline measures. Eighty four percent of families demonstrated one or more of the targeted risk factors for poor child development (low income; receives government benefits; single, socially isolated or young parent; culturally or linguistically diverse background). DISCUSSION: This study will provide unique data on the effectiveness of a brief group parenting intervention for enhancing the early home learning environment of young children from disadvantaged families. It will also provide evidence of the extent to which additional one-on-one support is required to achieve change and whether there are greater benefits when delivered in the 1st year of life or later. The program has been designed for scale-up across existing early childhood services if proven effective. TRIAL REGISTRATION: 8 September 2011; ACTRN12611000965909.

Background
The management of rheumatoid arthritis (RA) usually entails regular hospital reviews with a specialist often when the patient is well rather than during a period of exacerbation. An alternative approach where patients initiate appointments when they need them can improve patient satisfaction and resource use whilst being safe. This service evaluation reports a system wide implementation of a patient-initiated review appointment system called Direct Access (DA) for people with RA. The aim was to establish the impact on patient satisfaction of the new system versus usual care as well as evaluate the implementation processes.
Method
As all patients could not start on the new system at once, in order to manage the implementation, patients were randomly allocated to DA or to usual care. Instead of regular follow-up appointments, DA comprised an education session and access to a nurse-led telephone advice line where appointments could be accessed within two weeks. Usual care comprised routine follow-ups with the specialist. Data were collected on patient satisfaction, service use and outcomes of any contact to the advice line.
Results
Three hundred and eleven patients with RA were assessed as being suitable for DA. In terms of patient satisfaction, between-group differences were found in favour of DA for accessibility and convenience, ease of contacting the nurse and overall satisfaction with the service. Self-reported visits to the GP were also significantly lower. DA resulted in a greater number of telephone contacts (incidence rate ratio = 1.69; 95% CI 1.07 to 2.68). Hospital costs of the two different service models were similar. Mean waiting time for an appointment was 10.8 days
Conclusion
This service evaluation found that DA could be implemented and demonstrated patient benefit in a real world setting. Further research establishing the broader cost-consequences across the whole patient pathway would add to our findings.

BACKGROUND: Vitamin D deficiency has been linked with dementia risk, cognitive decline, and executive dysfunction. However, the association with memory remains largely unknown. OBJECTIVE: to investigate whether low serum 25-hydroxyvitamin D (25(OH)D) concentrations are associated with memory decline. METHODS: We used data on 1,291 participants from the US Cardiovascular Health Study (CHS) and 915 participants from the Dutch Longitudinal Aging Study Amsterdam (LASA) who were dementia-free at baseline, had valid vitamin D measurements, and follow-up memory assessments. The Benton Visual Retention Test (in the CHS) and Rey's Auditory Verbal Learning Test (in the LASA) were used to assess visual and verbal memory, respectively. RESULTS: in the CHS, those moderately and severely deficient in serum 25(OH)D changed -0.03 SD (95% CI: -0.06 to 0.01) and -0.10 SD (95% CI: -0.19 to -0.02) per year respectively in visual memory compared to those sufficient (p = 0.02). In the LASA, moderate and severe deficiency in serum 25(OH)D was associated with a mean change of 0.01 SD (95% CI: -0.01 to 0.02) and -0.01 SD (95% CI: -0.04 to 0.02) per year respectively in verbal memory compared to sufficiency (p = 0.34). CONCLUSIONS: Our findings suggest an association between severe vitamin D deficiency and visual memory decline but no association with verbal memory decline. They warrant further investigation in prospective studies assessing different memory subtypes.

BACKGROUND: Time from symptomatic presentation to cancer diagnosis (diagnostic interval) is an important, and modifiable, part of the patient's cancer pathway, and can be affected by various factors such as age, gender and type of presenting symptoms. The aim of this study was to quantify the relationships of diagnostic interval with these variables in 15 cancers diagnosed between 2007 and 2010 using routinely collected data from the Clinical Practice Research Datalink (CPRD) in the UK. METHODS: Symptom lists for each cancer were prepared from the literature and by consensus amongst the clinician researchers, which were then categorised into either NICE qualifying (NICE) or not (non-NICE) based on NICE Urgent Referral Guidelines for Suspected Cancer criteria. Multivariable linear regression models were fitted to examine the relationship between diagnostic interval (outcome) and the predictors: age, gender and symptom type. RESULTS: 18,618 newly diagnosed cancer patients aged ≥40 who had a recorded symptom in the preceding year were included in the analysis. Mean diagnostic interval was greater for older patients in four disease sites (difference in days per 10 year increase in age; 95% CI): bladder (10.3; 5.5 to 15.1; P

Background: Genetic carrier screening is increasingly possible for many conditions, but it is important to ensure decisions are informed. The multidimensional measure of informed choice (MMIC) is a quantitative instrument developed to evaluate informed choice in prenatal screening for Down syndrome, measuring knowledge, attitudes and uptake. To apply the MMIC in other screening settings, the knowledge scale must be modified. Objective: to develop and validate a modified MMIC knowledge scale for use with women undergoing carrier screening for fragile X syndrome (FXS). Setting and participants: Responses to MMIC items were collected through questionnaires as part of a FXS carrier screening pilot study in a preconception setting in Melbourne, Australia. Design: Ten knowledge scale items were developed using a modified Delphi technique. Cronbach's alpha and factor analysis were used to validate the new FXS knowledge scale. We summarized the knowledge, attitudes and informed choice status based on the modified MMIC. Results: Two hundred and eighty-five women were recruited, 241 eligible questionnaires were complete for analysis. The FXS knowledge scale items measured one salient construct and were internally consistent (alpha = 0.70). 71% (172/241) of participants were classified as having good knowledge, 70% (169/241) had positive attitudes and 27% (65/241) made an informed choice to accept or decline screening. Discussion and conclusions: We present the development of a knowledge scale as part of a MMIC to evaluate informed choice in population carrier screening for FXS. This can be used as a template by other researchers to develop knowledge scales for other conditions for use in the MMIC.

BACKGROUND: Genetic carrier screening is increasingly possible for many conditions, but it is important to ensure decisions are informed. The multidimensional measure of informed choice (MMIC) is a quantitative instrument developed to evaluate informed choice in prenatal screening for Down syndrome, measuring knowledge, attitudes and uptake. To apply the MMIC in other screening settings, the knowledge scale must be modified. OBJECTIVE: to develop and validate a modified MMIC knowledge scale for use with women undergoing carrier screening for fragile X syndrome (FXS). SETTING AND PARTICIPANTS: Responses to MMIC items were collected through questionnaires as part of a FXS carrier screening pilot study in a preconception setting in Melbourne, Australia. DESIGN: Ten knowledge scale items were developed using a modified Delphi technique. Cronbach's alpha and factor analysis were used to validate the new FXS knowledge scale. We summarized the knowledge, attitudes and informed choice status based on the modified MMIC. RESULTS: Two hundred and eighty-five women were recruited, 241 eligible questionnaires were complete for analysis. The FXS knowledge scale items measured one salient construct and were internally consistent (alpha = 0.70). 71% (172/241) of participants were classified as having good knowledge, 70% (169/241) had positive attitudes and 27% (65/241) made an informed choice to accept or decline screening. DISCUSSION AND CONCLUSIONS: We present the development of a knowledge scale as part of a MMIC to evaluate informed choice in population carrier screening for FXS. This can be used as a template by other researchers to develop knowledge scales for other conditions for use in the MMIC.

BACKGROUND: Minority ethnic groups in the UK have worse outcomes for some cancer types compared with the white majority. Black males have worse staging at diagnosis of prostate cancer and often present as emergencies, suggesting possible delays in the diagnostic pathway. Delay may arise from lower awareness of cancer symptoms, reluctance to report symptoms, reduced desire for investigation, or a combination of these. Reduced desire for investigation was examined in this study AIM: to investigate whether black males in the UK would choose to be tested for prostate cancer compared with the white majority. DESIGN AND SETTING: a vignette (hypothetical scenario)-based, electronic survey of male patients aged ≥40 years from four general practices in Bristol, UK. METHOD: the vignettes described possible prostate cancer symptoms (equating to risk levels of 2%, 5%, and 10%), investigative procedures, and possible outcomes. Participants indicated whether they would choose investigation in these scenarios. Analysis used logistic regression, with preference for investigation as the outcome variable and ethnicity as the main explanatory variable. RESULTS: in total, 449 (81%) of 555 participants opted for investigation, regardless of risk levels; of these, the acceptance rate was 94% (251 out of 267) among white males and 70% (198 out of 285) among black males. In multivariable analyses, preference for investigation was lower in black males, even after controlling for relevant confounding factors including specific risk level (odds ratio 0.13; 95% confidence interval = 0.07 to 0.25; P

Purpose – the purpose of this paper is to describe mental health-related contact with educational professionals amongst children in the British Child and Adolescent Mental Health Survey (BCAMHS) 2004. Design/methodology/approach – BCAMHS 2004 was a community-based survey of 5,325 children aged 5-16, with follow-up in 2007. This paper reports the percentage of children with a psychiatric disorder that had mental health-related contact with education professionals (categorised as teachers or specialist education services) and the percentage with specific types of psychiatric disorders amongst those contacting services. Findings – Two-thirds (66.1 per cent, 95 per cent CI: 62.4-69.8 per cent) of children with a psychiatric disorder had contact with a teacher regarding their mental health and 31.1 per cent (95 per cent CI: 27.5-34.7 per cent) had contact with special education either in 2004 or 2007, or both. Over half of children reporting special education contact (55.1 per cent, 95 per cent CI: 50.0-60.2 per cent) and almost a third reporting teacher contact in relation to mental health (32.1 per cent, 95 per cent CI: 29.7-34.6 per cent) met criteria for a psychiatric disorder. Practical implications – Many children in contact with education professionals regarding mental health experienced clinical levels of difficulty. Training is needed to ensure that contact leads to prompt intervention and referral if necessary. Originality/value – This is the first paper to report on mental health-related service contact with education professionals in the 2004 BCAMHS survey along with its 2007 follow-up. It identifies high levels of teacher contact which represent challenges in supporting staff with training, resources and access to mental health services.

© 2014 SEBDA. Childhood psychiatric disorders are associated with a wide range of adverse outcomes including poor academic attainment. For some children these difficulties are recognised through school Special Educational Need procedures (SEN) but many others may remain unidentified and/or unsupported. In Britain, government data suggests disproportionate representation of children with a SEN among children permanently excluded from school. This review asks whether school-aged children with impairing psychopathology were more likely to be excluded from school than those without. Databases covering education, social sciences, psychology and medicine were searched, experts were contacted and bibliographies of key papers were hand-searched. Studies were included if the population covered school-aged children, and if validated diagnostic measures had been used to assess psychopathology. Children with impairing psychopathology had greater odds of exclusion compared to the rest of the school-age population: odds ratios range from 1.13 (95% CI: 0.55–2.33) to 45.6 (95% CI: 3.8–21.3). These findings however need to be considered in light of the paucity of the literature and methodological weaknesses discussed.

AIM: the epidemiology of preschool speech sound disorder is poorly understood. Our aims were to determine: the prevalence of idiopathic speech sound disorder; the comorbidity of speech sound disorder with language and pre-literacy difficulties; and the factors contributing to speech outcome at 4 years. METHOD: One thousand four hundred and ninety-four participants from an Australian longitudinal cohort completed speech, language, and pre-literacy assessments at 4 years. Prevalence of speech sound disorder (SSD) was defined by standard score performance of ≤79 on a speech assessment. Logistic regression examined predictors of SSD within four domains: child and family; parent-reported speech; cognitive-linguistic; and parent-reported motor skills. RESULTS: at 4 years the prevalence of speech disorder in an Australian cohort was 3.4%. Comorbidity with SSD was 40.8% for language disorder and 20.8% for poor pre-literacy skills. Sex, maternal vocabulary, socio-economic status, and family history of speech and language difficulties predicted SSD, as did 2-year speech, language, and motor skills. Together these variables provided good discrimination of SSD (area under the curve=0.78). INTERPRETATION: This is the first epidemiological study to demonstrate prevalence of SSD at 4 years of age that was consistent with previous clinical studies. Early detection of SSD at 4 years should focus on family variables and speech, language, and motor skills measured at 2 years.

Purpose – the purpose of this paper is to explore the feasibility of a classroom management course as a public health intervention. Improved socio-emotional skills may boost children’s developmental and academic trajectory, while the costs of behaviour problems are enormous for schools with considerable impact on others’ well-being. Design/methodology/approach – in total, 40 teachers attended the Incredible Years (IY) Teacher Classroom Management (TCM) intervention in groups of ten. Afterwards teachers attended focus groups and semi-structured interviews were completed with headteachers to explore whether TCM was feasible, relevant and useful, research processes were acceptable and if it influenced teachers’ practice and pupils. Teachers completed standardised questionnaires about their professional self-efficacy, burnout and well-being before and after attendance. Findings – in all, 37/40 teachers completed the course. Teachers valued sharing experiences, the support of colleagues in the group and time out to reflect on practice and rehearse new techniques. Most teachers reported that they applied the strategies with good effect in their classrooms. Teachers’ questionnaires suggested an improvement in their self-efficacy in relation to classroom management (p=0.03); other scales changed in the predicted direction but did not reach statistical significance. Research limitations/implications – Although preliminary and small, these feasibility study findings suggest that it was worthwhile proceeding to a definitive randomised controlled trial (RCT). Practical implications – Should the RCT demonstrate effectiveness, then the intervention is an obvious candidate for implementation as a whole school approach. Originality/value – Successful intervention with one teacher potentially benefits every child that they subsequently teach and may increase the inclusion of socio-economically deprived children living in challenging circumstances in mainstream education.

This is the protocol for a review and there is no abstract. The objectives are as follows: to investigate the accuracy of hearing screening tests, individually or in combination, used in children at or around school entry age (four to eight years old), excluding children with known hearing loss and those unable to perform the test due to significant developmental delay. A secondary objective is to assess the relative diagnostic accuracy of different hearing screening tests when directly compared (within the same study).

OBJECTIVE: We have previously shown short-term benefits to phonology, letter knowledge, and possibly expressive language from systematically ascertaining language delay at age 4 years followed by the Language for Learning intervention. Here, we report the trial's definitive 6-year outcomes. METHODS: Randomized trial nested in a population-based ascertainment. Children with language scores >1.25 SD below the mean at age 4 were randomized, with intervention children receiving 18 1-hour home-based therapy sessions. Primary outcome was receptive/expressive language. Secondary outcomes were phonological, receptive vocabulary, literacy, and narrative skills; parent-reported pragmatic language, behavior, and health-related quality of life; costs of intervention; and health service use. For intention-to-treat analyses, trial arms were compared using linear regression models. RESULTS: of 1464 children assessed at age 4, 266 were eligible and 200 randomized; 90% and 82% of intervention and control children were retained respectively. By age 6, mean language scores had normalized, but there was little evidence of a treatment effect for receptive (adjusted mean difference 2.3; 95% confidence interval [CI] -1.2 to 5.7; P =. 20) or expressive (0.8; 95% CI -1.6 to 3.2; P =. 49) language. of the secondary outcomes, only phonological awareness skills (effect size 0.36; 95% CI 0.08-0.65; P =. 01) showed benefit. Costs were higher for intervention families (mean difference AU$4276; 95% CI: $3424 to $5128). CONCLUSIONS: Population-based intervention targeting 4-year-old language delay was feasible but did not have lasting impacts on language, possibly reflecting resolution in both groups. Long-term literacy benefits remain possible but must be weighed against its cost.

The 'Supporting Teachers and childRen in Schools' (STARS) study is a cluster randomised controlled trial evaluating the Incredible Years Teacher Classroom Management (TCM) programme as a public health intervention. TCM is a 6 day training course delivered to groups of 8-12 teachers. The STARS trial will investigate whether TCM can improve children's behaviour, attainment and wellbeing, reduce teachers' stress and improve their self-efficacy. This protocol describes the methodology of the process evaluation embedded within the main trial, which aims to examine the uptake and implementation of TCM strategies within the classroom plus the wider school environment and improve the understanding of outcomes.

BACKGROUND: the 'Supporting Teachers and childRen in Schools' (STARS) study is a cluster randomised controlled trial evaluating the Incredible Years Teacher Classroom Management (TCM) programme as a public health intervention. TCM is a 6 day training course delivered to groups of 8-12 teachers. The STARS trial will investigate whether TCM can improve children's behaviour, attainment and wellbeing, reduce teachers' stress and improve their self-efficacy. This protocol describes the methodology of the process evaluation embedded within the main trial, which aims to examine the uptake and implementation of TCM strategies within the classroom plus the wider school environment and improve the understanding of outcomes. METHODS/DESIGN: the STARS trial will work with eighty teachers of children aged 4-9 years from eighty schools. Teachers will be randomised to attend the TCM course (intervention arm) or to "teach as normal" (control arm) and attend the course a year later. The process evaluation will use quantitative and qualitative approaches to assess fidelity to model, as well as explore headteachers' and teachers' experiences of TCM and investigate school factors that influence the translation of skills learnt to practice. Four of the eight groups of teachers (n = 40) will be invited to participate in focus groups within one month of completing the TCM course, and again a year later, while 45 of the 80 headteachers will be invited to take part in telephone interviews. Standardised checklists will be completed by group leaders and each training session will be videotaped to assess fidelity to model. Teachers will also complete standardised session evaluations. DISCUSSION: This study will provide important information about whether the Teacher Classroom Management course influences child and teacher mental health and well-being in both the short and long term. The process evaluation will provide valuable insights into factors that may facilitate or impede any impact. TRIAL REGISTRATION: the trial has been registered with ISCTRN (Controlled Trials Ltd) and assigned an ISRCTN number ISRCTN84130388. Date assigned: 15 May 2012.

Assessing Pupils’ Progress (APP) arose from a government drive to increase the amount of teacher-based assessment within school and to make this consistent across schools. We conducted semi-structured interviews with head teachers to gain insight into how their schools applied APP and we compared the APP levels for English and Maths, provided by teachers across 11 schools for 72 pupils, to a standardised assessment (Wechsler Individual Achievement Test-II; WIAT). There was a strong correlation between the APP and WIAT for literacy but not for numeracy. Head teacher interviews revealed that APP is used differently across schools and at times is used in a way inconsistent with government guidance, which raises the question of how teacher assessments are used and their purpose. Questions that should be considered are; how is moderation used in schools, what is the function(s) of teacher assessments and what is good practice in relation to these assessments? Clarity about the function of assessments is of vital importance as is ensuring that assessments are meaningful to teachers, pupils, families and schools, especially in light of the weight that can be placed on teacher assessments for all these groups.

Objectives: to evaluate the diagnostic accuracy of C1q autoantibodies in identifying lupus nephritis (LN) in patients with systemic lupus erythematosus (SLE).
Data Sources and methods: Citation indexes were searched and 370 articles published from 1977 to 2013 were evaluated. The 31 selected studies included in the meta-analysis were cross-sectional in design. Among the 31 studies, 28 compared anti-C1q antibodies in 2769 SLE patients including those with (n = 1442) and without a history of LN (n = 1327). Nine studies examined anti-C1q in 517 SLE patients with active (n = 249) and inactive LN (n = 268). Hierarchical summary receiver operating characteristic (HSROC) random effects models were fitted to pool estimates of accuracy across the studies.
Results: Anti-C1q antibodies discriminated between patients with and without a history of LN, with a median specificity of 73.5%. The HSROC model estimated the corresponding sensitivity to be 70.4%. A hypothetical patient with a 55% prior probability of having a history of LN as opposed to no history (the median prevalence across 28 eligible studies) would have a post-test probability of 76.4% following a positive test result (positive predictive value) or 33.0% following a negative test result (negative predictive value). For differentiating active from inactive LN the median specificity of anti-C1q antibodies was 80%, with a corresponding estimated sensitivity value 75.7% based on the HSROC model. A hypothetical patient with a 56% prior probability of active. as opposed to inactive LN (the median prevalence across the 9 eligible studies) would have a post-test probability of 82.8% following a positive test result or 27.9% following a negative test result.
Conclusions: Although C1q antibodies are associated with lupus nephritis the post-test probabilities are not sufficiently convincing to provide reasonable certainty of the presence or absence of history of disease/active disease.

CONTEXT: Two widely used antithyroid drug (ATD) regimes for Graves' disease (GD) include the 'block & replace' (B&R) regime (a fixed high-dose of ATD combined with levothyroxine) and the 'titration' regime (a titrating dose of ATD). Anecdotally, it is believed that B&R is less prone to fluctuating thyroid function. OBJECTIVE: to study whether, in routine clinical practice, the B&R regime, compared with the titration regime, is associated with more stable thyroid function. METHODS: We retrospectively analysed case-records for 450 patients treated with ATDs for GD at a secondary care hospital. Exclusion criteria included treatment with ATDs for

Context Two widely used antithyroid drug (ATD) regimes for Graves' disease (GD) include the 'block & replace' (B&R) regime (a fixed high-dose of ATD combined with levothyroxine) and the 'titration' regime (a titrating dose of ATD). Anecdotally, it is believed that B&R is less prone to fluctuating thyroid function. Objective to study whether, in routine clinical practice, the B&R regime, compared with the titration regime, is associated with more stable thyroid function. Methods We retrospectively analysed case-records for 450 patients treated with ATDs for GD at a secondary care hospital. Exclusion criteria included treatment with ATDs for < 6 months, thyrotoxicosis due to other causes, treatment with radioiodine or thyroidectomy and pregnancy. Results Two hundred and twenty three patients were treated with the B&R regime ('B&R group'), 149 with the titration regime ('titration group') and 78 with both regimes. The number of thyroid function tests (TFTs) performed per year (mean (SD): 3.2(1.2) vs 3.4(1.5); adjusted mean difference = -0.4; 95% CI: -0.7 to -0.1; and P = 0.008) and the number of hospital clinic visits per year (mean (SD): 2.9 (1.0) vs 3.2 (1.3); adjusted mean difference = -0.4; 95% CI: -0.7 to -0.2; and P = 0.002) were lower in the B&R group than the titration group. The number of abnormal TFT results per year was similar in the two groups (mean(SD): 1.8(1.3) vs 1.8(1.4); adjusted mean difference = 0.05; 95%CI: -0.3 to 0.4; and P = 0.74). Conclusions in this retrospective study, there was little evidence that patients under B&R have more stable thyroid function. Further data from prospective studies, however, are needed to confirm this finding.

BACKGROUND: the primary aim was to use routine data to compare cancer diagnostic intervals before and after implementation of the 2005 NICE Referral Guidelines for Suspected Cancer. The secondary aim was to compare change in diagnostic intervals across different categories of presenting symptoms. METHODS: Using data from the General Practice Research Database, we analysed patients with one of 15 cancers diagnosed in either 2001-2002 or 2007-2008. Putative symptom lists for each cancer were classified into whether or not they qualified for urgent referral under NICE guidelines. Diagnostic interval (duration from first presented symptom to date of diagnosis in primary care records) was compared between the two cohorts. RESULTS: in total, 37,588 patients had a new diagnosis of cancer and of these 20,535 (54.6%) had a recorded symptom in the year prior to diagnosis and were included in the analysis. The overall mean diagnostic interval fell by 5.4 days (95% CI: 2.4-8.5; P

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 U.K. 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.

Background: Brief interventions delivered by family physicians to address excessive alcohol use among adult patients are effective. We conducted a study to determine whether such an intervention would be similarly effective in reducing binge drinking and excessive canna - bis use among young people. Methods: We conducted a cluster randomized controlled trial involving 33 family physicians in Switzerland. Physicians in the intervention group received training in delivering a brief intervention to young people during the consultation in addition to usual care. Physicians in the control group delivered usual care only. Consecutive patients aged 15-24 years were recruited from each practice and, before the consultation, completed a confidential questionnaire about their general health and substance use. Patients were followed up at 3, 6 and 12 months after the consultation. The primary outcome measure was self-reported excessive substance use (≥ 1 episode of binge drinking, or ≥ 1 joint of cannabis per week, or both) in the past 30 days. Results: of the 33 participating physicians, 17 were randomly allocated to the intervention group and 16 to the control group. of the 594 participating patients, 279 (47.0%) identified themselves as binge drinkers or excessive cannabis users, or both, at baseline. Excessive substance use did not differ significantly between patients whose physicians were in the intervention group and those whose physicians were in the control group at any of the follow-up points (odds ratio [OR] and 95% confidence interval [CI] at 3 months: 0.9 [0.6-1.4]; at 6 mo: 1.0 [0.6-1.6]; and at 12 mo: 1.1 [0.7-1.8]). The differences be - tween groups were also nonsignificant after we re stricted the analysis to patients who reported excessive substance use at baseline (OR 1.6, 95% CI 0.9-2.8, at 3 mo; OR 1.7, 95% CI 0.9-3.2, at 6 mo; and OR 1.9, 95% CI 0.9- 4.0, at 12 mo). Interpretation: Training family physicians to use a brief intervention to address excessive substance use among young people was not effective in reducing binge drinking and excessive cannabis use in this patient population. © 2014 Canadian Medical Association or its licensors.

OBJECTIVES: to examine the functional status (mental health, academic performance, peer problems) of a community-based sample of children who have attention-deficit/hyperactivity disorder (ADHD) and non-ADHD controls, and to investigate gender and subtype differences. METHODS: Children aged 6 to 8 years were recruited through 43 Melbourne schools, using a 2-stage screening (parent and teacher Conners 3 ADHD index) and case confirmation (Diagnostic Interview Schedule for Children, Version IV; [DISC-IV]) procedure. Outcome measures were mental health disorders (DISC-IV), academic performance (Wide Range Achievement Test 4), and peer problems (Strength and Difficulties Questionnaire). Unadjusted and adjusted linear and logistic regression were used to compare ADHD and non-ADHD controls. RESULTS: a total of 179 children who have ADHD and 212 non-ADHD controls were recruited. Compared with controls, children who had ADHD had higher odds of externalizing (odds ratio [OR], 11.0; 95% confidence interval [CI], 5.6-21.6; P <. 001) and internalizing (OR, 2.9; 95% CI, 1.2-7.2; P =. 02) disorders; poorer reading (effect size, -0.66) and mathematics (effect size, -0.69) performance; and more peer problems (P <. 001). Boys and girls who had ADHD were equally impaired. Only 17% of children in our ADHD group had been previously diagnosed. Previous diagnosis was higher in the Combined group and for boys. CONCLUSIONS: in their second year of school, children who had ADHD performed worse than controls across all functional domains, yet only a minority had been formally diagnosed with ADHD. Findings highlight the need for earlier diagnosis and intervention.

BACKGROUND: We have examined the association between adiposity and cardiac structure in adulthood, using a life course approach that takes account of the contribution of adiposity in both childhood and adulthood. METHODS: the Childhood Determinants of Adult Health study (CDAH) is a follow-up study of 8,498 children who participated in the 1985 Australian Schools Health and Fitness Survey (ASHFS). The CDAH follow-up study included 2,410 participants who attended a clinic examination. of these, 181 underwent cardiac imaging and provided complete data. The measures were taken once when the children were aged 9 to 15 years, and once in adult life, aged 26 to 36 years. RESULTS: There was a positive association between adult left ventricular mass (LVM) and childhood body mass index (BMI) in males (regression coefficient (β) 0.41; 95% confidence interval (CI): 0.14 to 0.67; p = 0.003), and females (β = 0.53; 95% CI: 0.34 to 0.72; p < 0.001), and with change in BMI from childhood to adulthood (males: β = 0.27; 95% CI: 0.04 to 0.51; p < 0.001, females: β = 0.39; 95% CI: 0.20 to 0.58; p < 0.001), after adjustment for confounding factors (age, fitness, triglyceride levels and total cholesterol in adulthood). After further adjustment for known potential mediating factors (systolic BP and fasting plasma glucose in adulthood) the relationship of LVM with childhood BMI (males: β = 0.45; 95% CI: 0.19 to 0.71; p = 0.001, females: β = 0.49; 95% CI: 0.29 to 0.68; p < 0.001) and change in BMI (males: β = 0.26; 95% CI: 0.04 to 0.49; p = 0.02, females: β = 0.40; 95% CI: 0.20 to 0.59; p < 0.001) did not change markedly. CONCLUSIONS: Adiposity and increased adiposity from childhood to adulthood appear to have a detrimental effect on cardiac structure.

OBJECTIVE: to determine, in a community-based sample of slow-to-talk toddlers, the extent to which specific maternal responsive behaviors at 24 months predict child language at 24 and 36 months. METHODS: Mother-child dyads were recruited for this prospective longitudinal study from 3 local government areas spanning low, middle, and high socioeconomic status in Melbourne, Australia. At child age 18 months, 1138 parents completed a 100-word expressive vocabulary checklist; the 251 (22.1%) children scoring ≤20th percentile were then followed up to comprise this study. PREDICTORS: Six maternal responsive behaviors (imitations, interpretations, labels, expansions, supportive directives and responsive questions) were derived from mother-child free-play videos collected at 24 months of age and coded using the Observer XT system. OUTCOMES: Expressive and receptive language measured at 24 and 36 months of age (Preschool Language Scale-4), blind to maternal responsiveness ratings. RESULTS: Two hundred and twenty-six of the 251 (90.0%) mother-child dyads were followed up at 36 months. In confounder-adjusted linear regression analyses, expansions, imitations, and responsive questions were strongly associated with better receptive and expressive language at 24 and 36 months. Labels unexpectedly predicted poorer expressive language at 36 months. Expansions were the only maternal behavior that predicted improvement in language between 24 and 36 months. CONCLUSIONS: Maternal responsive behaviors, particularly expansions, offer promise in enhancing early language learning in slow-to-talk toddlers. Parent-child interactions characterized by frequent use of maternal labels at 24 months could also be a predictive marker of those slow-to-talk toddlers at greater risk of persistent language problems.

BACKGROUND: Limited attention has been paid in the literature to multiple component fall prevention interventions that comprise two or more fixed combinations of fall prevention interventions that are not individually tailored following a risk assessment. The study objective was to determine the effect of multiple component interventions on fall rates, number of fallers and fall-related injuries among older people and to establish effect sizes of particular intervention combinations. METHODS: Medline, EMBASE, CINAHL, PsychInfo, Cochrane, AMED, UK Clinical Research Network Study Portfolio, Current Controlled Trials register and Australian and New Zealand Clinical Trials register were systematically searched to August 2013 for randomised controlled trials targeting those aged 60 years and older with any medical condition or in any setting that compared multiple component interventions with no intervention, placebo or usual clinical care on the outcomes reported falls, number that fall or fall-related injuries. Included studies were appraised using the Cochrane risk of bias tool. Estimates of fall rate ratio and risk ratio were pooled across studies using random effects meta-analysis. Data synthesis took place in 2013. RESULTS: Eighteen papers reporting 17 trials were included (5034 participants). There was a reduction in the number of people that fell (pooled risk ratio = 0.85, 95% confidence interval (95% CI) 0.80 to 0.91) and the fall rate (pooled rate ratio = 0.80, 95% CI 0.72 to 0.89) in favour of multiple component interventions when compared with controls. There was a small amount of statistical heterogeneity (I(2) =20%) across studies for fall rate and no heterogeneity across studies examining number of people that fell. CONCLUSIONS: This systematic review and meta-analysis of randomised controlled trials found evidence that multiple component interventions that are not tailored to individually assessed risk factors are effective at reducing both the number of people that fall and the fall rate. This approach should be considered as a service delivery option.

This is the protocol for a review and there is no abstract. The objectives are as follows: to determine the diagnostic accuracy of the plasma and CSF Abeta42 index tests for distinguishing Alzheimer's disease dementia from each of the other forms of dementia in people who meet the general criteria for a dementia syndrome. To investigate the heterogeneity of test accuracy in the included studies. We expect that heterogeneity will be likely and that it will be an important component of the review. The potential sources of heterogeneity, which will be used as a framework for the investigation of heterogeneity, include target population, index test, target disorder and study quality and are detailed in the analysis section.

The UK prevalence of parent-reported autism spectrum disorder (ASD) and attention deficit/hyperactivity disorder (ADHD) were estimated from the Millennium Cohort Study. Case definition was if a doctor or health care professional had ever told parents that their child had ASD and/or ADHD. Data were collected in 2008/2009 for 14,043 children. 1.7 % of children were reported as having ASD (95 % CI 1.4-2.0) at mean age 7.2 years (SD = 0.2; range = 6.3-8.2). 1.4 % reportedly had ADHD (95 % CI 1.2-1.7), and 0.3 % had both ASD and ADHD (95 % CI 0.2-0.5). After adjusting for socio-economic disadvantage, only male sex (p < 0.001 for both conditions) and cognitive ability, p = 0.004 (ASD); p = 0.01 (ADHD) remained strongly associated. The observed prevalence of parent-reported ASD is high compared to earlier UK and US estimates. Parent-reported ADHD is low compared to US estimates using the same measure. © 2013 Springer Science+Business Media New York.

The UK prevalence of parent-reported autism spectrum disorder (ASD) and attention deficit/hyperactivity disorder (ADHD) were estimated from the Millennium Cohort Study. Case definition was if a doctor or health care professional had ever told parents that their child had ASD and/or ADHD. Data were collected in 2008/2009 for 14,043 children. 1.7 % of children were reported as having ASD (95 % CI 1.4-2.0) at mean age 7.2 years (SD = 0.2; range = 6.3-8.2). 1.4 % reportedly had ADHD (95 % CI 1.2-1.7), and 0.3 % had both ASD and ADHD (95 % CI 0.2-0.5). After adjusting for socio-economic disadvantage, only male sex (p 

OBJECTIVES: the aims of this study were to estimate the prevalence of Ménière's disease and investigate its relationship with: demographic factors; symptoms and conditions that are known or hypothesized to be associated with Ménière's disease; other physical diseases; mental health. DESIGN: the authors used cross-sectional data from the UK Biobank to compare 1376 self-reported Ménière's participants with over 500,000 without Ménière's. The data set has comprehensive anthropometric measures, questionnaire data investigating health, well-being, diet, and medical and drug-prescribing history for each participant. The authors used logistic regression models to investigate the relationship of Ménière's disease with: demographic factors; symptoms and conditions that are known or hypothesized to be associated with Ménière's disease; other physical diseases; and mental health. RESULTS: Ménière's disease was more common in participants who were older (adjusted odds ratio per 10-year increase: 1.5 [95% confidence interval:1.4-1.6]), white (odds ratio: 1.7;1.2-2.3), female (1.4;1.3-1.6), and having higher body mass index categories (p < 0.001). The Ménière's group had greater odds of hearing difficulty (10.9;9.6-12.5), current tinnitus (68.3;47.8-97.5), and had fallen more than once in the last year (2.1;1.8-2.5). Ménière's participants had greater odds of reporting at least one disease from each grouping of allergic, immune dysfunction, or autonomic dysfunction (2.2;1.8-2.6), and poor mental health (2.1;1.8-2.5). CONCLUSIONS: This study provides an evidence base that improves understanding of Ménière's disease. Associations were noted with a number of diseases, and the authors hypothesize a role for the autonomic nervous system and immune system dysfunction in Ménière's etiology. The study also highlights the physical and mental health correlates of the condition.

Childhood psychiatric disorders are associated with a wide range of adverse outcomes including poor academic attainment. For some children these difficulties are recognised through school Special Educational Need procedures (SEN) but many others may remain unidentified and/or unsupported. In Britain, government data suggests disproportionate representation of children with a SEN among children permanently excluded from school. This review asks whether school-aged children with impairing psychopathology were more likely to be excluded from school than those without. Databases covering education, social sciences, psychology and medicine were searched, experts were contacted and bibliographies of key papers were hand-searched. Studies were included if the population covered school-aged children, and if validated diagnostic measures had been used to assess psychopathology. Children with impairing psychopathology had greater odds of exclusion compared to the rest of the school-age population: odds ratios range from 1.13 (95% CI: 0.55-2.33) to 45.6 (95% CI: 3.8-21.3). These findings however need to be considered in light of the paucity of the literature and methodological weaknesses discussed. © 2014 © 2014 SEBDA.

Objective: Pre-school communication problems are common, with implications for school readiness and educational achievement. Help is available from a variety of community healthcare providers. This study examined the extent to which help is received, and the predictors of service receipt. Design and setting: Prospective community study, in Melbourne, Victoria. Participants and method: at age 4 years, we assessed the speech, receptive and expressive language and fluency of 1607 children and gave feedback to their parents. At age 5 years, 983 families provided data on service use for communication problems between and 4 and 5 years. We compared service use between participants with and without impairment, and used logistic regression to estimate the strength of association between potential predictors (gender, socio-economic status, maternal education, English-speaking background status, family history of speech and language problems and parent concern) and service use (binary outcome). Results: Data were available for both communication status and service use for 753 children. Only 44.9% of the 196 children with communication impairment received help from a professional. Furthermore, 7% of the 557 that did not meet criteria for communication impairment nevertheless received help from a professional. Parent concern was the strongest predictor of service use (adjusted odds ratio = 9.0; 95% CI: 5.6-14.8). Conclusions: Both over- and under-servicing for communication problems were evident. This study shows that accessing help for communication problems requires more than simply informing parents about the problem and having services available; there is a need for systematic support to get the right children to services. © 2013 John Wiley & Sons Ltd.

OBJECTIVE: Pre-school communication problems are common, with implications for school readiness and educational achievement. Help is available from a variety of community healthcare providers. This study examined the extent to which help is received, and the predictors of service receipt. DESIGN AND SETTING: Prospective community study, in Melbourne, Victoria. PARTICIPANTS AND METHOD: at age 4 years, we assessed the speech, receptive and expressive language and fluency of 1607 children and gave feedback to their parents. At age 5 years, 983 families provided data on service use for communication problems between and 4 and 5 years. We compared service use between participants with and without impairment, and used logistic regression to estimate the strength of association between potential predictors (gender, socio-economic status, maternal education, English-speaking background status, family history of speech and language problems and parent concern) and service use (binary outcome). RESULTS: Data were available for both communication status and service use for 753 children. Only 44.9% of the 196 children with communication impairment received help from a professional. Furthermore, 7% of the 557 that did not meet criteria for communication impairment nevertheless received help from a professional. Parent concern was the strongest predictor of service use (adjusted odds ratio = 9.0; 95% CI: 5.6-14.8). CONCLUSIONS: Both over- and under-servicing for communication problems were evident. This study shows that accessing help for communication problems requires more than simply informing parents about the problem and having services available; there is a need for systematic support to get the right children to services.

Background: Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Although this is a major problem, relatively few adolescents with, or at risk of developing, depression are identified and referred for treatment. This suggests the need to investigate alternative approaches whereby preventative interventions are made widely available in schools. Objective: to investigate the clinical effectiveness and cost-effectiveness of classroom-based cognitive- behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents. Design: Cluster randomised controlled trial. Year groups (n = 28) randomly allocated on a 1: 1: 1 basis to one of three trial arms once all schools were recruited and balanced for number of classes, number of students, Personal, Social and Health Education (PSHE) lesson frequency, and scheduling of PSHE. Setting: Year groups 8 to 11 (ages 12-16 years) in mixed-sex secondary schools in the UK. Data were collected between 2009 and 2011. Participants: Young people who attended PSHE at participating schools were eligible (n = 5503). of the 5030 who agreed to participate, 1064 (21.2%) were classified as 'high risk': 392 in the classroom-based CBT arm, 374 in the attention control PSHE arm and 298 in the usual PSHE arm. Primary outcome data on the high-risk group at 12 months were available for classroom-based CBT (n = 296), attention control PSHE (n = 308) and usual PSHE (n = 242). Interventions: the Resourceful Adolescent Programme (RAP) is a focused CBT-based intervention adapted for the UK (RAP-UK) and delivered by two facilitators external to the school. Control groups were usual PSHE (usual school curriculum delivered by teachers) and attention control (usual school PSHE with additional support from two facilitators). Interventions were delivered universally to whole classes. Primary outcomes: Clinical effectiveness: symptoms of depression [Short Mood and Feelings Questionnaire (SMFQ)] in adolescents at high risk of depression 12 months from baseline. Cost-effectiveness: incremental cost-effectiveness ratios (ICERs) based on SMFQ score and quality-adjusted life-years (from European Quality of Life-5 Dimensions scores) between baseline and 12 months. Process evaluation: reach, attrition and qualitative feedback from service recipients and providers. Results: SMFQ scores had decreased for high-risk adolescents in all trial arms at 12 months, but there was no difference between arms [classroom-based CBT vs. usual PSHE adjusted difference in means 0.97, 95% confidence interval (CI) -0.34 to 2.28; classroom-based CBT vs. attention control PSHE -0.63, 95% CI -1.99 to 0.73]. Costs of interventions per child were estimated at £41.96 for classroom-based CBT and £34.45 for attention control PSHE. Fieller's method was used to obtain a parametric estimate of the 95% CI for the ICERs and construct the cost-effectiveness acceptability curve, confirming that classroom-based CBT was not cost-effective relative to the controls. Reach of classroom-based CBT was good and attrition was low (median 80% attending ≥ 60% of sessions), but feedback indicated some difficulties with acceptability and sustainability. Conclusions: Classroom-based CBT, attention control PSHE and usual PSHE produced similar outcomes. Classroom-based CBT may result in increased self-awareness and reporting of depressive symptoms. Classroom-based CBT was not shown to be cost-effective. While schools are a convenient way of reaching a wide range of young people, implementing classroom-based CBT within schools is challenging, particularly with regard to fitting programmes into a busy timetable, the lack of value placed on PSHE, and difficulties engaging with teachers and young people. Wider use of classroom-based depression prevention programmes should not be undertaken without further research. If universal preventative approaches are to be pursued, their clinical effectiveness and cost-effectiveness with younger children (aged 10-11 years), before the incidence of depression increases, should be investigated. Alternatively, the clinical effectiveness of indicated school-based programmes targeting those already displaying symptoms of depression should be investigated. © Queen's Printer and Controller of HMSO 2013.

OBJECTIVE: to assess the effectiveness of a parent-focused intervention on infants' obesity-risk behaviors and BMI. METHODS: This cluster randomized controlled trial recruited 542 parents and their infants (mean age 3.8 months at baseline) from 62 first-time parent groups. Parents were offered six 2-hour dietitian-delivered sessions over 15 months focusing on parental knowledge, skills, and social support around infant feeding, diet, physical activity, and television viewing. Control group parents received 6 newsletters on nonobesity-focused themes; all parents received usual care from child health nurses. The primary outcomes of interest were child diet (3 × 24-hour diet recalls), child physical activity (accelerometry), and child TV viewing (parent report). Secondary outcomes included BMI z-scores (measured). Data were collected when children were 4, 9, and 20 months of age. RESULTS: Unadjusted analyses showed that, compared with controls, intervention group children consumed fewer grams of noncore drinks (mean difference = -4.45; 95% confidence interval [CI]: -7.92 to -0.99; P =. 01) and were less likely to consume any noncore drinks (odds ratio = 0.48; 95% CI: 0.24 to 0.95; P =. 034) midintervention (mean age 9 months). At intervention conclusion (mean age 19.8 months), intervention group children consumed fewer grams of sweet snacks (mean difference = -3.69; 95% CI: -6.41 to -0.96; P =. 008) and viewed fewer daily minutes of television (mean difference = -15.97: 95% CI: -25.97 to -5.96; P =. 002). There was little statistical evidence of differences in fruit, vegetable, savory snack, or water consumption or in BMI z-scores or physical activity. CONCLUSIONS: This intervention resulted in reductions in sweet snack consumption and television viewing in 20-month-old children.

INTRODUCTION: Diabetes is a chronic condition associated with many long-term complications. People with diabetes need to actively manage their condition, which can be complex. In consultations with healthcare professionals, patients receive advice about their diabetes but do not always discuss things which concern them, perhaps because of the perceived limited time or embarrassment. We want to test a 'preconsultation' intervention in which the patient is supported by a healthcare assistant to complete a web-based intervention aimed at producing an agenda to help them identify important areas for discussion in the consultation. Use of this agenda may enable the patient to play a more active role in that consultation and consequently become more confident, and hence more successful, in managing their condition. METHODS AND ANALYSIS: in this pilot randomised controlled trial, 120 people with diabetes will be randomised with equal allocation to receive the intervention or usual clinical care. The primary outcome is reduction in glycosylated haemoglobin(HbA1c). Secondary outcomes are patient-reported communication, enablement, self-care activity, diabetes-dependent quality of life, empowerment, satisfaction, health-related quality of life and resource use. The aim of the pilot study was to estimate parameters to inform the design of the definitive trial. Follow-up on quantitative outcomes will be at 3 and 6 months. A nested qualitative study will collect data on the patients' experiences of producing an agenda. Resource use data and medication use will also be collected via a review of medical records for a sample of participants. ETHICS AND DISSEMINATION: Approval was granted by the NHS Research Ethics Committee North West-Preston (13/NW/0123). Dissemination will include publication of quantitative and qualitative findings, and experience of public involvement in peer-reviewed journals. Results will also be disseminated to trial participants via workshops led by lay coapplicants. TRIAL REGISTRATION: ISRCTN75070242.

PURPOSE: Newborn screening for cystic fibrosis is increasingly available, but cascade testing following the diagnosis in a child has received little attention. We previously reported low levels of cascade testing over time, and this study investigated motivators as well as barriers to testing. METHODS: Parents were interviewed about communicating the genetic information and also asked to recruit their relatives to receive a specifically developed questionnaire. RESULTS: Thirty parents were interviewed and addresses of 284 relatives were provided; completed questionnaires were received from 225 (79%). A relative's relationship to the child, as well as knowledge, is associated with having had carrier testing. Relatives' reasons for testing included curiosity and wanting information for other relatives and for reproductive planning. Reasons for not testing were perceived irrelevance, lacking awareness, and viewing it as something to do in the future. Parents communicated the genetic information to relatives in various ways, which contributed to whether relatives accessed carrier testing. CONCLUSION: Newborn screening programs should provide support to parents to aid communication of genetic information to relatives. (Ir)relevance of testing is often linked to life stage; ongoing support and communication may allow relatives to learn of their risk and then seek testing, if they wish, at a time perceived to be most relevant to them.

The need to improve the nutrition of the elderly living in long term care has long been recognised, but how this can best be achieved, and whether (and which) intervention is successful in reducing morbidity is less well understood. The aim of this systematic review was to determine the effectiveness of mealtime interventions for the elderly living in residential care. Mealtime interventions were considered as those that aimed to change/improve the mealtime routine, practice, experience or environment. Following comprehensive searches, review and appraisal, 37 articles were included. Inadequate reporting in over half of the articles limited data quality appraisal. Mealtime interventions were categorised into five types: changes to food service, food improvement, dining environment alteration, staff training and feeding assistance. Meta-analysis found inconsistent evidence of effects on body weight of changes to food service (0.5 kg; 95% CI: -1.1 to 2.2; p=0.51), food improvement interventions (0.4 kg; 95% CI: -0.8 to 1.7; p=0.50) or alterations to dining environment (1.5 kg; 95% CI: -0.7 to 2.8; p=0.23). Findings from observational studies within these intervention types were mixed, but generally positive. Observational studies also found positive effects on food/caloric intake across all intervention types, though meta-analyses of randomised studies showed little evidence of any effects on food/caloric intake in food improvement studies (-5 kcal; 95% CI: -36 to 26; p=0.74). There was some evidence of an effect on daily energy intakes within dining environment studies (181 kcal/day, 95% CI: -5 to 367, p=0.06). The need to improve the nutrition of the elderly living in residential long term care is well recognised. This review found some evidence that simple intervention around various aspects of mealtime practices and the mealtime environment can result in favourable nutritional outcomes. Further large scale pragmatic trials, however, are still required to establish full efficacy of such interventions.

BACKGROUND: Mindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness among young people. AIMS: to assess the acceptability and efficacy of a schools-based universal mindfulness intervention to enhance mental health and well-being. METHOD: a total of 522 young people aged 12-16 in 12 secondary schools either participated in the Mindfulness in Schools Programme (intervention) or took part in the usual school curriculum (control). RESULTS: Rates of acceptability were high. Relative to the controls, and after adjusting for baseline imbalances, children who participated in the intervention reported fewer depressive symptoms post-treatment (P = 0.004) and at follow-up (P = 0.005) and lower stress (P = 0.05) and greater well-being (P = 0.05) at follow-up. The degree to which students in the intervention group practised the mindfulness skills was associated with better well-being (P

BACKGROUND: Minimising diagnostic delays in cancer may help improve survival. Ethnic minorities have worse outcomes in some cancer types when compared to the majority; this may relate in part to differences during the diagnostic phase. Only a few British studies have specifically explored this relationship, and no synthesis of these exists. The present study aimed to systematically review evidence on ethnic inequalities in cancer diagnosis, focussing on patient and primary care intervals of diagnosis. METHODS: Six electronic databases were searched. Included studies were those conducted in the UK or elsewhere (where access to healthcare is comparable to the NHS) and those that described a time element during diagnosis. Study quality was evaluated using the Critical Appraisal Skills Programme (CASP) checklist for cohort studies and synthesis method was narrative. RESULTS: Seven of 8,520 studies retrieved by our search met the review criteria; six conducted in the UK, and one in New Zealand. Five (including one covering several sites) focused on breast cancer, one on prostate, and one on oesophagogastric cancer. The studies employed different methods of ascertainment and definition of ethnic groups and defined diagnostic delay in a non-standardised way; therefore, narrative synthesis was performed. In breast cancer, three studies reported longer diagnostic intervals among ethnic minorities and two found no evidence of differences by ethnicity. There was some evidence of longer diagnostic and referral intervals among ethnic minorities in oesophagogastric and colorectal cancers, but no evidence of this in prostate, non-Hodgkin's lymphoma, lung, and ovarian cancers. None of the studies identified shorter patient or primary care intervals in ethnic minorities. CONCLUSIONS: Existing studies provide insufficient evidence to confirm or refute ethnic inequalities in diagnostic intervals of cancer. Further studies are necessary to examine common cancer types including those frequently found in ethnic minorities (in addition to those covered here) and using current definitions of intervals in cancer diagnosis.

BACKGROUND:: Adherence to a Mediterranean diet has been associated with lower risk of various age-related diseases including dementia. Although narrative reviews have been published, no systematic review has synthesized studies on the association between Mediterranean diet adherence and cognitive function or dementia. METHODS:: We conducted a systematic review of 11 electronic databases (including Medline) of published articles up to January 2012. Reference lists, selected journal contents, and relevant websites were also searched. Study selection, data extraction, and quality assessment were performed independently by two reviewers using predefined criteria. Studies were included if they examined the association between a Mediterranean diet adherence score and cognitive function or dementia. RESULTS:: Twelve eligible papers (11 observational studies and one randomized controlled trial) were identified, describing seven unique cohorts. Despite methodological heterogeneity and limited statistical power in some studies, there was a reasonably consistent pattern of associations. Higher adherence to Mediterranean diet was associated with better cognitive function, lower rates of cognitive decline, and reduced risk of Alzheimer disease in nine out of 12 studies, whereas results for mild cognitive impairment were inconsistent. CONCLUSIONS:: Published studies suggest that greater adherence to Mediterranean diet is associated with slower cognitive decline and lower risk of developing Alzheimer disease. Further studies would be useful to clarify the association with mild cognitive impairment and vascular dementia. Long-term randomized controlled trials promoting a Mediterranean diet may help establish whether improved adherence helps to prevent or delay the onset of Alzheimer disease and dementia. © 2013 Lippincott Williams & Wilkins.

OBJECTIVES: to document the natural history of stuttering by age 4 years, including (1) cumulative incidence of onset, (2) 12-month recovery status, (3) predictors of stuttering onset and recovery, and (4) potential comorbidities. The study cohort was a prospective community-ascertained cohort (the Early Language in Victoria Study) from Melbourne, Australia, of 4-year-old children (n = 1619; recruited at age 8 months) and their mothers. METHODS: Outcome was stuttering onset by age 4 years and recovery within 12 months of onset, defined using concurrent monthly parent and speech pathologist ratings. Potential predictors: child gender, birth weight, birth order, prematurity, and twinning; maternal mental health and education; socioeconomic status; and family history of stuttering. Potential comorbidities: preonset and concurrent temperament, language, nonverbal cognition, and health-related quality of life. RESULTS: By age 4 years, the cumulative incidence of stuttering onset was 11.2% (95% confidence interval [CI]: 9.7% to 12.8%). Higher maternal education (P =. 004), male gender (P =. 02), and twinning (P =. 005) predicted stuttering onset. At outcome, stuttering children had stronger language (mean [SD]: 105.0 [13.0] vs 99.6 [14.6]; mean difference 5.5, 95% CI: 3.1 to 7.8; P <. 001) and nonverbal cognition (mean [SD]: 106.5 [11.4] vs 103.9 [13.7], mean difference 2.6, 95% CI: 0.4 to 4.8; P =. 02) and better health-related quality of life but were otherwise similar to their nonstuttering peers. Only 9 of 142 children (6.3%; 95% CI: 2.9% to 11.7%) recovered within 12 months of onset. CONCLUSIONS: Although stuttering onset is common in preschoolers, adverse affects are not the norm in the first year after onset.

Objectives: the study aims to test the hypothesis that physical activity (PA) and cardiorespiratory fitness (CRF) are associated with cardiometabolic risk factors; and to test the hypothesis that CRF modifies (changes the direction and/or strength of) the associations between PA and cardiometabolic risk factors. Methods: PA and CRF were objectively measured in the 2008 Health Survey for England and the present study included 536 adults who completed at least 4. min of the eight-minute sub-maximal step test and wore an accelerometer for at least 10. h on at least four days. Linear regression models were fitted to examine the relationship between PA and cardiometabolic risk factors and between CRF and cardiometabolic risk factors. A test of interaction was performed to examine whether CRF modifies the associations between PA and cardiometabolic risk factors. Results: PA and CRF were associated with HDL cholesterol, the ratio of total to HDL cholesterol, glycated haemoglobin and BMI after adjustment for potential confounders. There was little evidence that CRF changed the direction or strength of associations between PA and cardiometabolic risk factors. Conclusions: PA and CRF are associated with cardiometabolic risk factors. A larger sample is required to determine if CRF modifies associations between PA and cardiometabolic risk factors. © 2013 Elsevier Inc.

OBJECTIVES: the study aims to test the hypothesis that physical activity (PA) and cardiorespiratory fitness (CRF) are associated with cardiometabolic risk factors; and to test the hypothesis that CRF modifies (changes the direction and/or strength of) the associations between PA and cardiometabolic risk factors. METHODS: PA and CRF were objectively measured in the 2008 Health Survey for England and the present study included 536 adults who completed at least 4 min of the eight-minute sub-maximal step test and wore an accelerometer for at least 10 h on at least four days. Linear regression models were fitted to examine the relationship between PA and cardiometabolic risk factors and between CRF and cardiometabolic risk factors. A test of interaction was performed to examine whether CRF modifies the associations between PA and cardiometabolic risk factors. RESULTS: PA and CRF were associated with HDL cholesterol, the ratio of total to HDL cholesterol, glycated haemoglobin and BMI after adjustment for potential confounders. There was little evidence that CRF changed the direction or strength of associations between PA and cardiometabolic risk factors. CONCLUSIONS: PA and CRF are associated with cardiometabolic risk factors. A larger sample is required to determine if CRF modifies associations between PA and cardiometabolic risk factors.

This is the protocol for a review and there is no abstract. The objectives are as follows: to assess the effects of patient-initiated appointment systems compared with usual care in people with chronic or recurrent conditions managed in the secondary care setting. In particular, we are interested in whether these appointment systems can effectively manage disease without causing harm to patients and whether costs related to the provision of the service can be reduced compared with usual care.

AIM: to review the qualitative and quantitative evidence of the benefits of peer support for parents of children with disabling conditions in the context of health, well-being, impact on family, and economic and service implications. METHOD: We comprehensively searched multiple databases. Eligible studies evaluated parent-to-parent support and reported on the psychological health and experience of giving or receiving support. There were no limits on the child's condition, study design, language, date, or setting. We sought to aggregate quantitative data; findings of qualitative studies were combined using thematic analysis. Qualitative and quantitative data were brought together in a narrative synthesis. RESULTS: Seventeen papers were included: nine qualitative studies, seven quantitative studies, and one mixed-methods evaluation. Four themes were identified from qualitative studies: (1) shared social identity, (2) learning from the experiences of others, (3) personal growth, and (4) supporting others. Some quantitative studies reported a positive effect of peer support on psychological health and other outcomes; however, this was not consistently confirmed. It was not possible to aggregate data across studies. No costing data were identified. CONCLUSION: Qualitative studies strongly suggest that parents perceive benefit from peer support programmes, an effect seen across different types of support and conditions. However, quantitative studies provide inconsistent evidence of positive effects. Further research should explore whether this dissonance is substantive or an artefact of how outcomes have been measured.

BACKGROUND: Despite the health risks, physical inactivity is common. Identifying the correlates of physical activity to inform the design of interventions to reduce the disease burden associated with physical inactivity is a public health imperative. Rural adults have a unique set of characteristics influencing their activity behaviour, and are typically understudied, especially in England. The aim of this study was to identify the personal, social, and environmental correlates of physical activity in adults living in rural villages. METHODS: the study used baseline data from 2415 adults (response rate: 37.7%) participating in the first time period of a stepped-wedge cluster randomised trial, conducted in 128 rural villages from south-west England. Data collected included demographic characteristics, social factors, perception of the local environment, village level factors (percentage male, mean age, population density, Index of Multiple Deprivation, and sport market segmentation), and physical activity behaviour. Random effects ("multilevel") logistic regression models were fitted to the binary outcome whether individuals met physical activity guidelines, and random effects linear regression models were fitted to the continuous outcome MET-minutes per week leisure time physical activity, using the personal, social, environmental, and village-level factors as predictors. RESULTS: the following factors both increased the odds of meeting the recommended activity guidelines and were associated with more leisure-time physical activity: being male (p = 0.002), in good health (p < 0.001), greater commitment to being more active (p = 0.002), favourable activity social norms (p = 0.004), greater physical activity habit (p < 0.001), and recent use of recreational facilities (p = 0.01). In addition, there was evidence (p < 0.05) that younger age, lower body mass index, having a physical occupation, dog ownership, inconvenience of public transport, and using recreational facilities outside the local village were associated with greater reported leisure-time physical activity. None of the village-level factors were associated with physical activity. CONCLUSIONS: This study adds to the current literature on the correlates of physical activity behaviour by focusing on a population exposed to unique environmental conditions. It highlights potentially important correlates of physical activity that could be the focus of interventions targeting rural populations, and demonstrates the need to examine rural adults separately from their urban counterparts.

OBJECTIVES: Targeting physical activity (PA) is a mainstay in obesity treatment, but its BMI benefits are poorly quantified. We studied long-term predictive PA-BMI relationships in overweight/obese children presenting to primary care. METHODS: Three-year follow-up of 182 overweight/obese 5- to 10-year-olds recruited from 45 Melbourne general practices. PREDICTOR: 7-day accelerometry (counts per minute, cpm). OUTCOMES: change in BMI z score, BMI category, and clinically significant BMI improvement (z score change ≥0.5). ANALYSIS: Linear and logistic regression. RESULTS: Mean (SD) baseline and 3-year BMI z scores were 1.8 (0.6) and 1.8 (0.7), and mean (SD) activity scores 334 (111) and 284 (104) cpm, respectively. Baseline activity did not predict BMI change. However, for every 100 cpm increase in change in activity over 3 years, BMI z score fell by 0.11 (95% confidence interval [CI] 0.03-0.20; P =. 006). There were also trends toward greater odds of staying in the same, versus moving to a higher, BMI category (odds ratio 1.85, 95% CI 0.99-3.46) and clinically significant BMI improvement (odds ratio 1.96, 95% CI 0.90-4.27; P =. 09). Change in percentage time spent in moderate-vigorous (P =. 01), but not sedentary (P =. 39) or light (P =. 59), activity predicted reduced BMI z score. CONCLUSIONS: Sustained increase in moderate-vigorous PA predicts reducing BMI z score over 3 years in overweight/obese children presenting to primary care. However, the small BMI change associated with even the largest activity changes may explain disappointing BMI outcomes of brief primary care interventions targeting PA.

OBJECTIVE: Population approaches to lessen the adverse impacts of preschool language delay remain elusive. We aimed to determine whether systematic ascertainment of language delay at age 4 years, followed by a 10-month, 1-on-1 intervention, improves language and related outcomes at age 5 years. METHODS: a randomized trial nested within a cross-sectional ascertainment of language delay. Children with expressive and/or receptive language scores more than 1.25 SD below the mean at age 4 years entered the trial. Children randomly allocated to the intervention received 18 1-hour home-based therapy sessions. The primary outcomes were receptive and expressive language (Clinical Evaluation of Language Fundamentals - Preschool, 2(nd) Edition) and secondary outcomes were child phonological skills, letter awareness, pragmatic skills, behavior, and quality of life. RESULTS: a total of 1464 children were assessed for language delay at age 4 years. of 266 eligible children, 200 (13.6%) entered the trial, with 91 intervention (92% of 99) and 88 control (87% of 101) children retained at age 5 years. At age 5 years, there was weak evidence of benefit to expressive (adjusted mean difference, intervention - control, 2.0; 95% confidence interval [CI] -0.5 to 4.4; P =. 12) but not receptive (0.6; 95% CI -2.5 to 3.8; P =. 69) language. The intervention improved phonological awareness skills (5.0; 95% CI 2.2 to 7.8; P <. 001) and letter knowledge (2.4; 95% CI 0.3 to 4.5; P =. 03), but not other secondary outcomes. CONCLUSIONS: a standardized yet flexible 18-session language intervention was successfully delivered by non-specialist staff, found to be acceptable and feasible, and has the potential to improve long-term consequences of early language delay within a public health framework.

BACKGROUND: Attention-Deficit/Hyperactivity Disorder (ADHD) affects approximately 5% of children worldwide and results in significant impairments in daily functioning. Few community-ascertained samples of children with ADHD have been studied prospectively to identify factors associated with differential outcomes. The Children's Attention Project is the first such study in Australia, examining the mental health, social, academic and quality of life outcomes for children with diagnostically-confirmed ADHD compared to non-ADHD controls. The study aims to map the course of ADHD symptoms over time and to identify risk and protective factors associated with differential outcomes. METHODS/DESIGN: the sample for this prospective longitudinal study is being recruited across 43 socio-economically diverse primary schools across Melbourne, Australia. All children in Grade 1, the second year of formal schooling (6-8 years), are screened for ADHD symptoms using independent parent and teacher reports on the Conners' 3 ADHD index (~N = 5260). Children screening positive for ADHD by both parent and teacher report, and a matched sample (gender, school) screening negative, are invited to participate in the longitudinal study. At baseline this involves parent completion of the NIMH Diagnostic Interview Schedule for Children IV (DISC-IV) to confirm likely ADHD diagnostic status and identify other mental health difficulties, direct child assessments (cognitive, academic, language and executive functioning; height and weight) and questionnaires for parents and teachers assessing outcomes, as well as a broad range of risk and protective factors (child, parent/family, teacher/school, and socio-economic factors). Families will be initially followed up for 3 years. DISCUSSION: This study is the first Australian longitudinal study of children with ADHD and one of the first community-based longitudinal studies of diagnostically confirmed children with ADHD. The study's examination of a broad range of risk and protective factors and ADHD-related outcomes has the potential to inform novel strategies for intervention and prevention.

This is the protocol for a review and there is no abstract. The objectives are as follows: to determine the diagnostic accuracy of the 18F-FDG-PET index test for detecting people with MCI at baseline who would clinically convert to Alzheimer's disease or other forms of dementia at follow-up. To investigate heterogeneity of test accuracy in the included studies. We expect that heterogeneity will be likely and that it will be an important component of the review. The potential sources of heterogeneity, which will be used as a framework for the investigation of heterogeneity, include target population, index test, target disorder and study quality and are detailed in the analysis section.

BACKGROUND: Venous thromboembolism (VTE) is a major cause of morbidity and mortality in hospitalised patients. VTE prevention has been identified as a major health need internationally to improve patient safety. A National Institute for Health and Clinical Excellence (NICE) guideline was issued in February 2010. Its key priorities were to assess patients for risk of VTE on admission to hospital, assess patients for bleeding risk and evaluate the risks and benefits of prescribing VTE prophylaxis. The aim of this study was to evaluate the implementation of NICE guidance and its impact on patient safety. METHODS: a before-after observational design was used to investigate changes in VTE risk assessment documentation and inappropriate prescribing of prophylaxis between the year prior to (2009) and the year following (2010) the implementation of NICE guidance, using data from a 3-week period during each year. A total of 408 patients were sampled in each year across four hospitals in the NHS South region. RESULTS: Implementation strategies such as audit, education and training were used. The percentage of patients for whom a VTE risk assessment was documented increased from 51.5% (210/408) in 2009 to 79.2% (323/408) in 2010; difference 27.7% (95% CI: 21.4% to 33.9%; p < 0.001). There was little evidence of change in the percentage who were prescribed prophylaxis amongst patients without a risk assessment (71.7% (142/198) in 2009 and 68.2% (58/85) in 2010; difference -3.5% (95% CI: -15.2% to 8.2%; p =0.56) nor the percentage who were prescribed low molecular weight heparin amongst patients with a contraindication (14% (4/28) in 2009 and 15% (6/41) in 2010; RD = 0.3% (95% CI: -16.5% to 17.2%; p =0.97). CONCLUSIONS: the documentation of risk assessment improved following the implementation of NICE guidance; it is questionable, however, whether this led to improved patient safety with respect to prescribing appropriate prophylaxis.

BACKGROUND: the number of thyroid function tests (TFTs) performed in the UK and other countries has increased considerably in recent years. Inconsistent clinical practice associated with inappropriate requests for tests is thought to be an important cause for this increase. AIM: to study the extent of variability in requests for TFTs from general practices. METHODS: We analysed routine data on all TFTs on patients aged 16 years and over carried out by two hospitals in south-west England (Royal Cornwall Hospital and Royal Devon & Exeter Hospital) during 2010 at the request of 107 general practices. RESULTS: a total of 195 309 TFT requests were made for 148 412 patients (63% female). The total requests included 192 108 tests for thyroid-stimulating hormone (TSH), 43 069 for free thyroxine (FT4) and 1972 for free tri-iodothyronine (FT3). The number of TSH tests per 1000 list size varied widely across the practices, ranging from 84 to 482. Most of the variation was due to heterogeneity across practices and only 24% of this was accounted for by prevalence of hypothyroidism and socio-economic deprivation. CONCLUSIONS: There is wide variation in TFT requests from general practice and scope to reduce both unnecessary TFTs and the variability in the clinical practice. Further studies are required to understand the causes for the variability in testing thyroid function.

Background: Nilotinib and dasatinib are now being considered as alternative treatments to imatinib as a first-line treatment of chronic myeloid leukaemia (CML). Objective: This technology assessment reviews the available evidence for the clinical effectiveness and cost-effectiveness of dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of Philadelphia chromosome-positive CML. Data sources: Databases [including MEDLINE (Ovid), EMBASE, Current Controlled Trials, ClinicalTrials.gov, the US Food and Drug Administration website and the European Medicines Agency website] were searched from search end date of the last technology appraisal report on this topic in October 2002 to September 2011. Review methods: a systematic review of clinical effectiveness and cost-effectiveness studies; a review of surrogate relationships with survival; a review and critique of manufacturer submissions; and a model-based economic analysis. Results: Two clinical trials (dasatinib vs imatinib and nilotinib vs imatinib) were included in the effectiveness review. Survival was not significantly different for dasatinib or nilotinib compared with imatinib with the 24-month follow-up data available. The rates of complete cytogenetic response (CCyR) and major molecular response (MMR) were higher for patients receiving dasatinib than for those with imatinib for 12 months' follow-up (CCyR 83% vs 72%, p < 0.001; MMR 46% vs 28%, p < 0.0001). The rates of CCyR and MMR were higher for patients receiving nilotinib than for those receiving imatinib for 12 months' followup (CCyR 80% vs 65%, p < 0.001; MMR 44% vs 22%, p < 0.0001). An indirect comparison analysis showed no difference between dasatinib and nilotinib for CCyR or MMR rates for 12 months' follow-up (CCyR, odds ratio 1.09, 95% CI 0.61 to 1.92; MMR, odds ratio 1.28, 95% CI 0.77 to 2.16). There is observational association evidence from imatinib studies supporting the use of CCyR and MMR at 12 months as surrogates for overall all-cause survival and progression-free survival in patients with CML in chronic phase. In the costeffectiveness modelling scenario, analyses were provided to reflect the extensive structural uncertainty and different approaches to estimating OS. First-line dasatinib is predicted to provide very poor value for money compared with first-line imatinib, with deterministic incremental cost-effectiveness ratios (ICERs) of between £256,000 and £450,000 per quality-adjusted life-year (QALY). Conversely, first-line nilotinib provided favourable ICERs at the willingness-to-pay threshold of £20,000-30,000 per QALY. Limitations: Immaturity of empirical trial data relative to life expectancy, forcing either reliance on surrogate relationships or cumulative survival/treatment duration assumptions. Conclusions: from the two trials available, dasatinib and nilotinib have a statistically significant advantage compared with imatinib as measured by MMR or CCyR. Taking into account the treatment pathways for patients with CML, i.e. assuming the use of secondline nilotinib, first-line nilotinib appears to be more cost-effective than first-line imatinib. Dasatinib was not cost-effective if decision thresholds of £20,000 per QALY or £30,000 per QALY were used, compared with imatinib and nilotinib. Uncertainty in the costeffectiveness analysis would be substantially reduced with better and more UK-specific data on the incidence and cost of stem cell transplantation in patients with chronic CML. Funding: the Health Technology Assessment Programme of the National Institute for Health Research. © Queen's Printer and Controller of HMSO 2012.

OBJECTIVE: Mental health problems are an international public health issue affecting a substantial proportion of youth. This study aimed to identify groups of young children exhibiting distinct internalising and externalising symptom trajectories across early childhood compared to existing norms. Linear regression then identified child, parenting and family predictors from infancy in the development of internalising and externalising behaviours at age 5 years. METHOD: This consisted of a follow-up of 5-year-old children from a longitudinal, population-based study with earlier surveys having been completed by primary caregivers when the children were aged 7, 12, 18, 24 and 36 months. Five hundred 5-year-olds (68% retention) were included from 733 children recruited at age 6-7 months from routine well-child appointments across six socio-economically diverse government areas in Victoria, Australia. Mothers then completed a further questionnaire when their children reached 5 years of age, repeating the instruments included in previous waves. The primary outcomes were the Child Behavior Checklist (CBCL), 1.5-5 internalising and externalising symptoms (T-scores in relation to norms) and behaviours (raw scores). RESULTS: Across early childhood, three distinct profiles for each of the internalising and externalising symptoms (T-scores) were identified and compared to CBCL norms. Around 20% of this Australian child population exhibited consistently elevated symptoms for each problem. Regarding aetiology, longitudinally the strongest predictors of internalising behaviours at 5 years of age were harsh discipline, maternal stress, having no older siblings, single parenthood and maternal substance misuse. The strongest predictors of externalising behaviours at 5 years of age were male sex, harsh discipline and maternal stress. The predictors explained 22% of the variation in internalising behaviours and 24% of the variation in externalising behaviours at 5 years. CONCLUSIONS: Starting as early as the toddler period, effective population approaches to preventing mental health problems are needed. Randomised trials of preventive interventions focused on improving parenting practices and reducing maternal stress are under way.

BACKGROUND AND OBJECTIVES: Randomized trials have demonstrated the short- to medium-term effectiveness of behavioral infant sleep interventions. However, concerns persist that they may harm children's emotional development and subsequent mental health. This study aimed to determine long-term harms and/or benefits of an infant behavioral sleep program at age 6 years on (1) child, (2) child-parent, and (3) maternal outcomes. METHODS: Three hundred twenty-six children (173 intervention) with parent-reported sleep problems at age 7 months were selected from a population sample of 692 infants recruited from well-child centers. The study was a 5-year follow-up of a population-based cluster-randomized trial. Allocation was concealed and researchers (but not parents) were blinded to group allocation. Behavioral techniques were delivered over 1 to 3 individual nurse consultations at infant age 8 to 10 months, versus usual care. The main outcomes measured were (1) child mental health, sleep, psychosocial functioning, stress regulation; (2) child-parent relationship; and (3) maternal mental health and parenting styles. RESULTS: Two hundred twenty-five families (69%) participated. There was no evidence of differences between intervention and control families for any outcome, including (1) children's emotional (P =. 8) and conduct behavior scores (P =. 6), sleep problems (9% vs 7%, P =. 2), sleep habits score (P =. 4), parent- (P =. 7) and child-reported (P =. 8) psychosocial functioning, chronic stress (29% vs 22%, P =. 4); (2) child-parent closeness (P =. 1) and conflict (P =. 4), global relationship (P =. 9), disinhibited attachment (P =. 3); and (3) parent depression, anxiety, and stress scores (P =. 9) or authoritative parenting (63% vs 59%, P =. 5). CONCLUSIONS: Behavioral sleep techniques have no marked long-lasting effects (positive or negative). Parents and health professionals can confidently use these techniques to reduce the short- to medium-term burden of infant sleep problems and maternal depression.

Objective: to determine the emergent literacy and language effects of a low-intensity literacy promotion program (Let's Read) provided via universal well-child services to parents during the first 4 years of their child's life. Design : Population-based, cluster randomized controlled trial performed between March 1, 2006, and December 10, 2010. Setting: Maternal and child health centers (clusters) in 5 relatively disadvantaged local government areas in Melbourne, Australia. Participants: all parents attending their 4-week well-child appointments in participating centers were invited to take part in the study. Intervention: the Let's Read program was delivered at 4, 12, 18, and 42 months during universal well-child care visits. Main Outcome Measure: Child emergent literacy skills (intrasyllabic, phonemic, and sound/letter knowledge) and language (core, receptive, and expressive), measured at 4 years of age. Results: a total of 630 parents participated, with 365 children in 32 intervention clusters and 265 children in 33 control clusters; 563 children (89.4%) were retained in the study to 4 years of age. The adjusted mean differences (intervention minus control) for emergent literacy was 0.2 (95% CI, -0.2 to 0.6; P =.29) for intrasyllabic units, 0.05 (95% CI, -0.4 to 0.5; P =.85) for phonemic awareness, and 0.1 (95% CI, -1.5 to 1.6; P =.92) for letter knowledge. For language, the differences were 1.6 (95% CI, -1.1 to 4.3; P =.25) for core, 0.8 (95% CI, -2.0 to 3.7; P =.56) for receptive, and 1.4 (95% CI, -1.4 to 4.2; P =.32) for expressive scores. Conclusion: This population-wide primary care literacy promotion and book distribution program provided neither the anticipated benefits to literacy and language nor enhanced uptake of literacy activities at 4 years of age, even when targeted to relatively disadvantaged areas. Trial Registration: isrctn.org Identifier: ISRCTN04602902. ©2012 American Medical Association. All rights reserved.

BACKGROUND: Early language delay is a high-prevalence condition of concern to parents and professionals. It may result in lifelong deficits not only in language function, but also in social, emotional/behavioural, academic and economic well-being. Such delays can lead to considerable costs to the individual, the family and to society more widely. The Language for Learning trial tests a population-based intervention in 4 year olds with measured language delay, to determine (1) if it improves language and associated outcomes at ages 5 and 6 years and (2) its cost-effectiveness for families and the health care system. METHODS/DESIGN: a large-scale randomised trial of a year-long intervention targeting preschoolers with language delay, nested within a well-documented, prospective, population-based cohort of 1464 children in Melbourne, Australia. All children received a 1.25-1.5 hour formal language assessment at their 4th birthday. The 200 children with expressive and/or receptive language scores more than 1.25 standard deviations below the mean were randomised into intervention or 'usual care' control arms. The 20-session intervention program comprises 18 one-hour home-based therapeutic sessions in three 6-week blocks, an outcome assessment, and a final feed-back/forward planning session. The therapy utilises a 'step up-step down' therapeutic approach depending on the child's language profile, severity and progress, with standardised, manualised activities covering the four language development domains of: vocabulary and grammar; narrative skills; comprehension monitoring; and phonological awareness/pre-literacy skills. Blinded follow-up assessments at ages 5 and 6 years measure the primary outcome of receptive and expressive language, and secondary outcomes of vocabulary, narrative, and phonological skills. DISCUSSION: a key strength of this robust study is the implementation of a therapeutic framework that provides a standardised yet tailored approach for each child, with a focus on specific language domains known to be associated with later language and literacy. The trial responds to identified evidence gaps, has outcomes of direct relevance to families and the community, includes a well-developed economic analysis, and has the potential to improve long-term consequences of early language delay within a public health framework. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03981121.

Objectives: to examine whether infant sleep problems predict (1) sleep problems and (2) poorer outcomes at the age of six years. Methods: We studied a community-based cohort of 326 six-year-olds recruited to a randomized trial of a behavioral sleep intervention for sleep problems at age seven months. Predictors were parent-reported child sleep problems at ages 4, 12, and 24. months (" yes" vs. " no" ). There were a number of parent reported six-year-old outcomes: (1) Child sleep problem (" moderate/large" vs. " none/small" ) and Child Sleep Habits Questionnaire (CSHQ); (2) child and maternal mental and global health, child health-related quality of life (HRQoL, also child-reported), and child-parent relationship. The analyses were composed of multivariable models, adjusting for potential confounders and six-year sleep problems, examining whether each outcome was predicted by each infant sleep problem entered simultaneously. In a second set of analyses the predictor was the count of the number of waves with a sleep problem. Results: a total of 225 (69%) families participated at six years. The CSHQ Total increased 0.5 points (95% CI: 0.4 to 2.4. p= 0.006) with each additional infant sleep problem, but there was little evidence that sleep problems at one or more time points during early childhood predicted other child, maternal, or child-parent outcomes at six years. Conclusion: Infant sleep problems, whether transient, recurring, or persistent, do not predict long-term outcomes. Clinicians should focus on reducing child sleep problems and their considerable short-to-medium term impacts as they arise during childhood. © 2012 Elsevier B.V.

OBJECTIVES: to examine whether infant sleep problems predict (1) sleep problems and (2) poorer outcomes at the age of six years. METHODS: We studied a community-based cohort of 326 six-year-olds recruited to a randomized trial of a behavioral sleep intervention for sleep problems at age seven months. Predictors were parent-reported child sleep problems at ages 4, 12, and 24 months ("yes" vs. "no"). There were a number of parent reported six-year-old outcomes: (1) Child sleep problem ("moderate/large" vs. "none/small") and Child Sleep Habits Questionnaire (CSHQ); (2) child and maternal mental and global health, child health-related quality of life (HRQoL, also child-reported), and child-parent relationship. The analyses were composed of multivariable models, adjusting for potential confounders and six-year sleep problems, examining whether each outcome was predicted by each infant sleep problem entered simultaneously. In a second set of analyses the predictor was the count of the number of waves with a sleep problem. RESULTS: a total of 225 (69%) families participated at six years. The CSHQ Total increased 0.5 points (95% CI: 0.4 to 2.4, p=0.006) with each additional infant sleep problem, but there was little evidence that sleep problems at one or more time points during early childhood predicted other child, maternal, or child-parent outcomes at six years. CONCLUSION: Infant sleep problems, whether transient, recurring, or persistent, do not predict long-term outcomes. Clinicians should focus on reducing child sleep problems and their considerable short-to-medium term impacts as they arise during childhood.

BACKGROUND: Externalising and internalising problems affect one in seven school-aged children and are the single strongest predictor of mental health problems into early adolescence. As the burden of mental health problems persists globally, childhood prevention of mental health problems is paramount. Prevention can be offered to all children (universal) or to children at risk of developing mental health problems (targeted). The relative effectiveness and costs of a targeted only versus combined universal and targeted approach are unknown. This study aims to determine the effectiveness, costs and uptake of two approaches to early childhood prevention of mental health problems ie: a Combined universal-targeted approach, versus a Targeted only approach, in comparison to current primary care services (Usual care). METHODS/DESIGN: Three armed, population-level cluster randomised trial (2010-2014) within the universal, well child Maternal Child Health system, attended by more than 80% of families in Victoria, Australia at infant age eight months.Participants were families of eight month old children from nine participating local government areas. Randomised to one of three groups: Combined, Targeted or Usual care.The interventions comprises (a) the Combined universal and targeted program where all families are offered the universal Toddlers Without Tears group parenting program followed by the targeted Family Check-Up one-on-one program or (b) the Targeted Family Check-Up program. The Family Check-Up program is only offered to children at risk of behavioural problems.Participants will be analysed according to the trial arm to which they were randomised, using logistic and linear regression models to compare primary and secondary outcomes. An economic evaluation (cost consequences analysis) will compare incremental costs to all incremental outcomes from a societal perspective. DISCUSSION: This trial will inform public health policy by making recommendations about the effectiveness and cost-effectiveness of these early prevention programs. If effective prevention programs can be implemented at the population level, the growing burden of mental health problems could be curbed. TRIAL REGISTRATION: ISRCTN61137690.

Background Pre-school language impairment is common and greatly reduces educational performance. Population attempts to identify children who would benefit from appropriately timed intervention might be improved by greater knowledge about the typical profiles of language development. Specifically, this could be used to help with the early identification of children who will be impaired on school entry. Methods This study applied longitudinal latent class analysis to assessments at 8, 12, 24, 36 and 48 months on 1113 children from a population-based study, in order to identify classes exhibiting distinct communicative developmental profiles. Results Five substantive classes were identified: Typical, i.e. development in the typical range at each age; Precocious (late), i.e. typical development in infancy followed by high probabilities of precocity from 24 months onwards; Impaired (early), i.e. high probabilities of impairment up to 12 months followed by typical language development thereafter; Impaired (late), i.e. typical development in infancy but impairment from 24 months onwards; Precocious (early), i.e. high probabilities of precocity in early life followed by typical language by 48 months. The entropy statistic (0.84) suggested classes were fairly well defined, although there was a non-trivial degree of uncertainty in classification of children. That half of the Impaired (late) class was expected to have typical language at 4 years and 6% of the numerically large Typical class was expected to be impaired at 4 years illustrates this. Characteristics indicative of social advantage were more commonly found in the classes with improving profiles. Conclusions Developmental profiles show that some pre-schoolers' language is characterized by periods of accelerated development, slow development and catch-up growth. Given the uncertainty in classifying children into these profiles, use of this knowledge for identifying children who will be impaired on school entry is not straightforward. The findings do, however, indicate greater need for language enrichment programmes among disadvantaged children. © 2011 Blackwell Publishing Ltd.

BACKGROUND: Pre-school language impairment is common and greatly reduces educational performance. Population attempts to identify children who would benefit from appropriately timed intervention might be improved by greater knowledge about the typical profiles of language development. Specifically, this could be used to help with the early identification of children who will be impaired on school entry. METHODS:   This study applied longitudinal latent class analysis to assessments at 8, 12, 24, 36 and 48 months on 1113 children from a population-based study, in order to identify classes exhibiting distinct communicative developmental profiles. RESULTS: Five substantive classes were identified: Typical, i.e. development in the typical range at each age; Precocious (late), i.e. typical development in infancy followed by high probabilities of precocity from 24 months onwards; Impaired (early), i.e. high probabilities of impairment up to 12 months followed by typical language development thereafter; Impaired (late), i.e. typical development in infancy but impairment from 24 months onwards; Precocious (early), i.e. high probabilities of precocity in early life followed by typical language by 48 months. The entropy statistic (0.84) suggested classes were fairly well defined, although there was a non-trivial degree of uncertainty in classification of children. That half of the Impaired (late) class was expected to have typical language at 4 years and 6% of the numerically large Typical class was expected to be impaired at 4 years illustrates this. Characteristics indicative of social advantage were more commonly found in the classes with improving profiles. CONCLUSIONS: Developmental profiles show that some pre-schoolers' language is characterized by periods of accelerated development, slow development and catch-up growth. Given the uncertainty in classifying children into these profiles, use of this knowledge for identifying children who will be impaired on school entry is not straightforward. The findings do, however, indicate greater need for language enrichment programmes among disadvantaged children.

UNLABELLED: This study examined the relationship between family functioning and attention-deficit/hyperactivity disorder (ADHD) symptoms in an Australian community-based sample. Children were screened for ADHD in their second year of formal schooling. Two hundred and two (202) primary caregivers completed validated measures of family quality of life (QoL), parent mental health, parenting styles and parental relationship quality. Compared with controls, parents of children screening positive for ADHD reported poorer family QoL in the domains of emotional impact (mean difference [MD] -20.1; 95% CI -38.2 to -1.9, p = 0.03) and impact on family activities (MD -17.2; 95% CI -27.9 to -6.5, p = 0.002), less parental warmth (MD -3.4; 95% CI -6.0 to -0.9, p = 0.01) and higher parental depression (MD 6.8; 95% CI 1.8 to 11.7, p = 0.009) and anxiety (MD 6.2; 95% CI 1.7 to 10.6, p = 0.008) after adjusting for socio-demographic characteristics and child conduct symptoms. Parents of children screening positive for ADHD reported higher stress (MD 4.5; 95% CI 1.2 to 7.1, p = 0.007) and more inconsistent (MD 3.0; 95% CI 1.2 to 4.8, p = 0.002) and hostile (MD = 2.2; 95% CI 1.0 to 3.4, p = 0.001) parenting after adjusting for socio-demographic factors only. No difference in parental relationship quality and parental inductive reasoning was identified. CONCLUSION: These findings suggest a strong association between poor family functioning and ADHD symptoms and carry implications for comprehensive ADHD management and the importance of seeing the child within the family context.

BACKGROUND: Childhood antisocial behaviour has high immediate and long-term costs for society and the individual, particularly in relation to mental health and behaviours that jeopardise health. Managing challenging behaviour is a commonly reported source of stress and burn out among teachers, ultimately resulting in a substantial number leaving the profession. Interventions to improve parenting do not transfer easily to classroom-based problems and the most vulnerable parents may not be easily able to access them. Honing teachers' skills in proactive behaviour management and the promotion of socio-emotional regulation, therefore, has the potential to improve both child and teacher mental health and well-being and the advantage that it might potentially benefit all the children subsequently taught by any teacher that accesses the training. METHODS/DESIGN: Cluster randomised controlled trial (RCT) of the Incredible Years teacher classroom management (TCM) course with combined economic and process evaluations.One teacher of children aged 4-9 years, from 80 schools in the South West Peninsula will be randomised to attend the TCM (intervention arm) or to "teach as normal" (control arm). The primary outcome measure will be the total difficulties score from the Strengths and Difficulties Questionnaire (SDQ) completed by the current class teachers prior to randomisation, and at 9, 18 and 30 months follow-up, supplemented by parent SDQs. Secondary measures include academic attainment (teacher report supplemented by direct measurement in a sub-sample), children's enjoyment of school, and teacher reports of their professional self-efficacy, and levels of burn out and stress, supplemented by structured observations of teachers classroom management skills in a subsample. Cost data for the economic evaluation will be based on parental reports of services accessed. Cost-effectiveness, using the SDQ as the measure of effect, will be examined over the period of the RCT and over the longer term using decision analytic modelling. The process evaluation will use quantitative and qualitative approaches to assess fidelity to model, as well as explore Head teacher and teachers' experiences of TCM and investigate school factors that influence the translation of skills learnt to practice. DISCUSSION: This study will provide important information about whether the Teacher Classroom Management course influences child and teacher mental health and well-being in both the short and long term. It will also provide valuable insights into factors that may facilitate or impede any impact.The trial has been registered with ISCTRN (Controlled Trials Ltd) and assigned an ISRCTN number ISRCTN84130388. (http://www.controlled-trials.com/isrctn/search.html?srch=ISRCTN84130388&sort=3&dir=desc&max=10).

BACKGROUND: Although physical inactivity has been linked with numerous chronic health conditions and overall mortality, the majority of English adults report doing insufficient physical activity. To increase population physical activity levels, researchers have called for more community-level interventions. To evaluate these complex public health interventions, innovative study designs are required. This study protocol describes Devon Active Villages, a community-level intervention providing physical activity opportunities to 128 rural villages in southwest England, and the methods used to evaluate its effectiveness in increasing physical activity levels. METHODS/DESIGN: a stepped wedge cluster randomised trial will be used to evaluate whether Devon Active Villages leads to increased physical activity levels in rural communities. Community engagement will help tailor activity programmes for each village; communities will then be supported for a further twelve months. The intervention will be delivered over four periods, each lasting twelve weeks. Data collection consists of a postal survey of a random sample of adults aged 18 years and over, at baseline and after each of the four intervention periods. The questionnaire includes questions on participant demographics, physical activity behaviour, local environment characteristics, awareness of local activity programmes, and psychosocial factors. Based on detecting an increase in the proportion of people who meet physical activity guidelines (from 25% to 30%), at least ten respondents are needed from each of the 128 villages at each stage (80% power at the 5% level of significance). Anticipating a 20% response rate, 6,400 questionnaires will be sent out at each stage (i.e. 50 surveys to each village). Using data from all five periods, a comparison of study outcomes between intervention and control arms will be performed, allowing for time period (as a fixed effect) and the random effect induced by correlation of outcomes (clustering) within villages. DISCUSSION: This paper describes the use of a stepped wedge cluster randomised trial to evaluate a complex, community-level physical activity intervention in an under-studied population of adults in rural communities in southwest England. The study addresses gaps in the current literature by providing new insights into physical activity levels in this population. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN37321160.

OBJECTIVE: to determine the feasibility of screening for child sleep problems and the efficacy of a behavioral sleep intervention in improving child and parent outcomes in the first year of schooling. METHODS: a randomized controlled trial was nested in a population survey performed at 22 elementary schools in Melbourne, Australia. Intervention involved 2 to 3 consultations that covered behavioral sleep strategies for children whose screening results were positive for a moderate/severe sleep problem. Outcomes were parent-reported child sleep problem (primary outcome), sleep habits, psychosocial health-related quality of life, behavior, and parent mental health (all at 3, 6, and 12 months) and blinded, face-to-face learning assessment (at 6 months). RESULTS: the screening survey was completed by 1512 parents; 161 (10.8%) reported a moderate/severe child sleep problem, and 108 of 136 (79.2% of those eligible) entered the trial. Sleep problems tended to resolve more rapidly in intervention children. Sleep problems affected 33% of 54 intervention children versus 43% of 54 control children at 3 months (P =. 3), 25.5% vs 46.8% at 6 months (P =. 03), and 32% vs 33% at 12 months (P =. 8). Sustained sleep-habit improvements were evident at 3, 6, and 12 months (effect sizes: 0.33 [P =. 03]; 0.51 [P =. 003]; and 0.40 [P =. 02]; respectively), and there were initial marked improvements in psychosocial scores that diminished over time (effect sizes: 0.47 [P =. 02]; 0.41 [P =. 09]; and 0.26 [P =. 3]; respectively). Better prosocial behavior was evident at 12 months (effect size: 0.35; P =. 03), and learning and parent outcomes were similar between groups. CONCLUSIONS: School-based screening for sleep problems followed by a targeted, brief behavioral sleep intervention is feasible and has benefits relevant to school transition.

To investigate the association between change in daily step count and both adiposity and insulin sensitivity and the extent to which the association between change in daily step count and insulin sensitivity may be mediated by adiposity.

Many parents do not recognize that their young children are overweight or obese, possibly because epidemiological cutpoints may not reflect parent perceptions of overweight. We determined whether any Body mass index (BMI) cutpoint reliably triggers parent concern, drawing on the first wave (2004) of the Longitudinal Study of Australian Children (LSAC). BMI (kg/m(2)) and parent concern about their child's weight categorized in three different ways (any, moderately or greater, very) were available for 4,983 children aged 4-5. We used logistic regression to assess the relationship between BMI and parent concern, and receiver operating characteristic (ROC) curves to determine BMI cutpoints that best discriminate parent concern. Parent concern about their pre-schoolers' weight related only modestly to body mass and was not triggered by any definable BMI threshold. This may partly explain why current childhood obesity policies are ineffective, as they typically require individual concern leading to family behavioural change.

BACKGROUND: Enteral feeding is a common method of nutrition support when oral intake is inadequate. Confirmation of correct nasogastric (NG) tube placement is essential. Risks of morbidity/mortality associated with misplacement in the lung are well documented. Studies indicate that pH ≤ 4 confirms gastric aspirate, but in pediatrics, a pH of gastric aspirate is often >4. The goal of this study was to determine a reliable and practical pH value to confirm NG tube placement, without increasing the risk of not identifying a misplaced NG tube. METHODS: Pediatric inpatients older than 4 weeks receiving enteral nutrition (nasogastric or gastrostomy) were recruited over 9 months. Aspirate samples were pH tested at NG tube placement and before feedings. If pH >4, NG tube position was confirmed by chest radiograph or further investigations. In addition, intensive care unit (ICU) patients who required endotracheal suctioning were recruited, and endotracheal aspirate samples were pH tested. RESULTS: a total of 4,330 gastric aspirate samples (96% nasogastric) were collected from 645 patients with a median (interquartile range [IQR]) age of 1.0 years (0.3-5.2 years). The mean (standard deviation [SD]) pH of these gastric samples was 3.6 (1.4) (range, 0-9). pH was >4 in 1,339 (30.9%) gastric aspirate samples, and of these, 244 were radiographed, which identified 10 misplaced tubes (1 with pH 5.5). A total of 65 endotracheal aspirate samples were collected from 19 ICU patients with a median (IQR) age of 0.6 years (0.4-5.2 years). The mean (SD) pH of these samples was 8.4 (0.8) (range, 6-9.5). CONCLUSION: Given that the lowest pH value of endotracheal aspirate sample was 6, and a misplaced NG tube was identified with pH 5.5, it is proposed that a gastric aspirate pH ≤ 5 is a safer, reliable, and practical cutoff in this population.

OBJECTIVE: Short sleep duration may contribute to childhood obesity. Amenable to intervention, sleep thus provides a potential path for prevention. The authors aimed to determine the impact of a behavioural intervention that successfully reduced parent-reported infant sleep problems on adiposity at age 6. DESIGN: 5-year follow-up of a previously reported population-based cluster randomised trial. Participant allocation was concealed to researchers and data collection blinded. SETTING: Recruitment from well-child centres in Melbourne, Australia. PARTICIPANTS: 328 children (174 intervention) with parent-reported sleep problems at age 7-8 months drawn from 49 centres (clusters). INTERVENTION: Behavioural sleep strategies delivered over one to three structured individual nurse consultations from 8 to 10 months, versus usual care. MAIN OUTCOMES AT AGE 6 YEARS: Body mass index (BMI) z-score, percentage overweight/obese and waist circumference. ANALYSES: Intention-to-treat regression analyses adjusted for potential confounders. RESULTS: Anthropometric data were available for 193 children (59% retention) at age 6. There was no evidence of a difference between intervention (N=101) and control (N=92) children for BMI z-score (adjusted mean difference 0.2, 95% CI -0.1 to 0.4), overweight/obese status (20% vs 17%; adjusted OR 1.4, 95% CI 0.7 to 2.8) and waist circumference (adjusted mean difference -0.3, 95% CI -1.6 to 1.1). In posthoc analyses, neither infant nor childhood sleep duration were associated with anthropometric outcomes. CONCLUSIONS: a brief infant sleep intervention did not reduce overweight/obesity at 6 years. Population-based primary care sleep services seem unlikely to reduce the early childhood obesity epidemic.

OBJECTIVE: to examine the effect of lifestyle changes on the stability of blood lipid and lipoprotein levels from youth to adulthood. DESIGN: Prospective cohort study. SETTING: Australia. PARTICIPANTS: Five hundred thirty-nine young adults who underwent measurement at baseline in 1985 when aged 9, 12, or 15 years and again at follow-up between 2004 and 2006. MAIN EXPOSURES: Changes in adiposity, cardiorespiratory fitness, saturated fat intake, smoking, and socioeconomic position. MAIN OUTCOME MEASURES: Child and adult blood lipid levels. RESULTS: Using established cut points, we found that substantial proportions of individuals with high-risk blood lipid and lipoprotein levels at baseline no longer had high-risk levels at follow-up. of the participants who had high-risk levels in youth, those with greater increases in adiposity or who commenced or continued smoking were more likely to maintain high-risk blood lipid and lipoprotein levels (P <. 05). Participants who became high risk at follow-up had greater increases in adiposity, were less likely to improve their socioeconomic position, and tended to become less fit between surveys compared with those who maintained normal-risk levels (P ≤. 05). These effects tended to remain (P ≤. 10) after adjustment for all predictive lifestyle variables. CONCLUSIONS: Unhealthy lifestyle changes that occur between youth and adulthood affect whether an individual maintains, loses, or develops high-risk blood lipid and lipoprotein levels in adulthood. Interventions that promote weight control in the first instance, but also physical activity, not smoking, and improved socioeconomic position in the transition from youth to adulthood, are likely to be of benefit in preventing adult dyslipidemia.

OBJECTIVE: to investigate pedometer-measured physical activity (PA) in 2000 and change in PA over 5 years with subsequent risk of dysglycemia by 2005. RESEARCH DESIGN AND METHODS: This prospective cohort study in Tasmania, Australia, analyzed 458 adults with normal glucose tolerance and a mean (SD) age of 49.7 (12.1) years in 2000. Variables assessed in 2000 and 2005 included PA, by pedometer and questionnaire, nutrient intake, and other lifestyle factors. Incident dysglycemia was defined as the development of impaired fasting glucose or impaired glucose tolerance revealed by oral glucose tolerance testing in 2005, without type 2 diabetes. RESULTS: Incident dysglycemia developed in 26 participants during the 5-year period. Higher daily steps in 2000 were independently associated with a lower 5-year risk of incident dysglycemia (adjusted odds ratio [AOR] 0.87 [95% CI 0.77-0.97] per 1,000-step increment). Higher daily steps in 2005, after controlling for baseline steps in 2000 (thus reflecting change in steps over 5 years), were not associated with incident dysglycemia (AOR 1.02 [0.92-1.14]). Higher daily steps in 2000 were also associated with lower fasting blood glucose, but not 2-h plasma glucose by 2005. Further adjustment for BMI or waist circumference did not remove these associations. CONCLUSIONS: Among community-dwelling adults, a higher rate of daily steps is associated with a reduced risk of incident dysglycemia. This effect appears to be not fully mediated through reduced adiposity.

BACKGROUND: Early shared reading and literacy promotion benefits have stimulated international interest in the development of early-years literacy-promotion programs despite limited evidence of effectiveness at a broader population level. OBJECTIVE: to determine whether a population-based primary care literacy promotion intervention during the first 2 years of life improves early markers of subsequent literacy by 2 years of age. DESIGN AND METHODS: This cluster randomized controlled trial took place in 5 relatively disadvantaged areas in Melbourne, Australia. Infants attending their maternal and child health centers were recruited at age 1-2 months. The intervention (4-8, 12, and 18 months) comprised maternal and child health nurses modelling shared reading activities to parents, supported by parent information and free books. Outcomes (at 2 years) included expressive vocabulary (MacArthur Bates Communicative Development Inventory), communication (Communication and Symbolic Behavior Scales), and home literacy environment (StimQ-Toddler). We analyzed the outcomes using random-effects (linear regression) models allowing for clustering. RESULTS: a total of 552 families (87.6%; 324 intervention and 228 control families) of 630 recruited families (66.5% response) were retained to outcome. A total of 97.3% of intervention parents received some (93.7% to all) of the intervention. At 2 years, the trial arms had similar vocabulary (adjusted mean difference: -2.0 [95% confidence interval: -6.2 to 2.2]; P =. 36), communication (adjusted mean difference: 0.2 [95% confidence interval: -2.3 to 2.7]; P =. 87), and home literacy (adjusted mean difference: -0.4 [95% confidence interval: -1.0 to 0.2]; P =. 21). CONCLUSIONS: This universal literacy-promotion program was not beneficial in relatively disadvantaged communities by the age of 2 years and may be ineffective. Alternative interpretations may relate to program intensity, reach and/or sleeper effects. Definitive outcomes at 4 years are awaited.

OBJECTIVE: to determine the benefits of a low intensity parent-toddler language promotion programme delivered to toddlers identified as slow to talk on screening in universal services. DESIGN: Cluster randomised trial nested in a population based survey. SETTING: Three local government areas in Melbourne, Australia. PARTICIPANTS: Parents attending 12 month well child checks over a six month period completed a baseline questionnaire. At 18 months, children at or below the 20th centile on an expressive vocabulary checklist entered the trial. INTERVENTION: Maternal and child health centres (clusters) were randomly allocated to intervention (modified "You Make the Difference" programme over six weekly sessions) or control ("usual care") arms. MAIN OUTCOME MEASURES: the primary outcome was expressive language (Preschool Language Scale-4) at 2 and 3 years; secondary outcomes were receptive language at 2 and 3 years, vocabulary checklist raw score at 2 and 3 years, Expressive Vocabulary Test at 3 years, and Child Behavior Checklist/1.5-5 raw score at 2 and 3 years. RESULTS: 1217 parents completed the baseline survey; 1138 (93.5%) completed the 18 month checklist, when 301 (26.4%) children had vocabulary scores at or below the 20th centile and were randomised (158 intervention, 143 control). 115 (73%) intervention parents attended at least one session (mean 4.5 sessions), and most reported high satisfaction with the programme. Interim outcomes at age 2 years were similar in the two groups. Similarly, at age 3 years, adjusted mean differences (intervention-control) were -2.4 (95% confidence interval -6.2 to 1.4; P=0.21) for expressive language; -0.3 (-4.2 to 3.7; P=0.90) for receptive language; 4.1 (-2.3 to 10.6; P=0.21) for vocabulary checklist; -0.5 (-4.4 to 3.4; P=0.80) for Expressive Vocabulary Test; -0.1 (-1.6 to 1.4; P=0.86) for externalising behaviour problems; and -0.1 (-1.3 to 1.2; P=0. 92) for internalising behaviour problems. CONCLUSION: This community based programme targeting slow to talk toddlers was feasible and acceptable, but little evidence was found that it improved language or behaviour either immediately or at age 3 years. TRIAL REGISTRATION: Current Controlled Trials ISRCTN20953675.

This study examined the prenatal, postnatal and demographic predictors of parent-reported attention-deficit/hyperactivity disorder (ADHD) in an Australian population-based sample. Participants were families participating in the Longitudinal Study of Australian Children. There were approximately even numbers of males (51%) and females (49%) in the sample. Predictors of parent-reported ADHD status at Wave 2 (children aged 6-7 years) which were measured at Wave 1 (children aged 4-5 years) included cigarette smoking and alcohol use during pregnancy (prenatal factors); maternal postnatal depression, intensive care at birth, birth weight, and gestation (postnatal factors); and child gender, primary caregiver education, income, family composition, and maternal age at childbirth (socio-demographic factors). We found that male gender, cigarette smoking during pregnancy, and maternal postnatal depression were the only significant predictors (at the 5% level) of ADHD in the adjusted analysis (N = 3,474). Our results are consistent with previous findings that male gender and cigarette smoking during pregnancy are risk factors for ADHD. In addition, we found that postnatal depression was predictive of parent-reported ADHD.

OBJECTIVE: to determine predictors of child externalizing (behavioral) and internalizing (emotional) symptoms in a national population sample. METHODS: Data were collected in 3 biennial waves (2004, 2006, and 2008) from 2 cohorts in the Longitudinal Study of Australian Children, initially including 5107 children 0 to 1 year of age and 4983 children 4 to 5 years of age. The primary outcomes were child externalizing and internalizing symptoms. Relationships between potential risk factors and child mental health outcomes were described by using linear regression. RESULTS: in unadjusted analyses, children's mental health symptoms were predicted by a large number of risk factors. In multivariate models, early childhood factors (birth through 5 years) explained 30% and 18% of variations in externalizing and internalizing symptoms, respectively, at 4 to 5 years of age. Middle childhood (5-9 years of age) factors explained 20% and 23% of variations in externalizing and internalizing symptoms, respectively, at 8 to 9 years of age. Harsh discipline was a strong consistent predictor of externalizing symptoms in both age groups, whereas poorer child physical health, maternal emotional distress, harsh discipline, and overinvolved/protective parenting (younger cohort only) predicted internalizing symptoms consistently. CONCLUSIONS: National data on predictors of child mental health symptoms highlighted a small number of significant risk factors, situated in the family context and present from a very young age. This knowledge is informing population-level, randomized, prevention trials of family support programs.

BACKGROUND: Compelling evidence shows that appropriate use of anticoagulation in patients with nonvalvular atrial fibrillation reduces the risk of ischaemic stroke by 67% and all-cause mortality by 26%. Despite this evidence, anticoagulation is substantially underused, resulting in avoidable fatal and disabling strokes. METHODS: DESPATCH is a cluster randomised controlled trial with concealed allocation and blinded outcome assessment designed to evaluate a multifaceted and tailored implementation strategy for improving the uptake of anticoagulation in primary care. We have recruited general practices in South Western Sydney, Australia, and randomly allocated practices to receive the DESPATCH intervention or evidence-based guidelines (control). The intervention comprises specialist decisional support via written feedback about patient-specific cases, three academic detailing sessions (delivered via telephone), practice resources, and evidence-based information. Data for outcome assessment will be obtained from a blinded, independent medical record audit. Our primary endpoint is the proportion of nonvalvular atrial fibrillation patients, over 65 years of age, receiving oral anticoagulation at any time during the 12-month posttest period. DISCUSSION: Successful translation of evidence into clinical practice can reduce avoidable stroke, death, and disability due to nonvalvular atrial fibrillation. If successful, DESPATCH will inform public policy, providing quality evidence for an effective implementation strategy to improve management of nonvalvular atrial fibrillation, to close an important evidence-practice gap. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12608000074392.

BACKGROUND: the World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety) will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry. METHODS/DESIGN: This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500) with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (cost-consequences framework) will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively) to compare outcomes between the trial arms. DISCUSSION: This trial addresses gaps for internalising problems identified in the 2004 World Health Organization Prevention of Mental Disorders report. If effective and cost-effective, the intervention could readily be applied at a population level. Governments consider mental health to be a priority, enhancing the likelihood that an effective early prevention program would be adopted in Australia and internationally. RCH HUMAN RESEARCH ETHICS APPROVAL: 30105A.

This article discusses the importance of and one approach to translational research to prevent internalizing problems very early in life. The World Health Organisation (WHO) predicts that by 2,030 internalizing problems will be second only to HIV/AIDS in the international burden of disease. Internalizing problems affect one in every seven school age children, with negative impacts on peer relations, school engagement, and later mental health, adult relationships, and employment. There is persuasive evidence that intervention in the preschool years can have a cost-effective impact on general developmental outcomes, compared to later school or adult intervention. However, the development of early childhood prevention for internalizing problems is in its infancy. Two significant risk factors for child internalizing problems are temperamental inhibition (characterized by fearfulness and withdrawal) and overinvolved/protective parenting practices. Rapee et al. have conducted two randomized "efficacy" trials with inhibited preschoolers in which a parenting group intervention reduced internalizing disorders up to 3 years later. Translational "effectiveness" research is now underway at the population level, to determine the balance of benefits and harms of systematically screening preschoolers for inhibition and subsequent intervention for all those affected. This rigorous public health research, followed by effective dissemination, addresses gaps identified in the WHO Prevention of Mental Disorders report.

OBJECTIVE: to determine whether adverse perinatal outcomes are increased in subfertile women. DESIGN: Cohort study. SETTING: Two tertiary assisted reproductive technologies (ART) centers; Victorian births register. PATIENT(S): Records of women who registered with the clinics (1991-2000), but did not have an infant using ART, were linked to the birth register (1991-2004) to identify singleton non-ART births within 5 years of registration (N = 2171). Controls, matched by maternal age and year of infant's birth, were selected randomly from birth records (N = 4363). INTERVENTIONS: None. MAIN OUTCOME MEASURE(S): Adverse obstetric and perinatal outcomes. RESULT(S): After adjusting for confounders, compared with controls, subfertile women had increased odds of hypertension or preeclampsia (adjusted odds ratio [OR] 1.29, 1.02-1.61), antepartum hemorrhage (adjusted OR 1.41, 1.05-1.89), perinatal death (adjusted OR 2.19, 1.10-4.36), low birth weight (adjusted OR 1.44, 1.11-1.85), preterm birth

Confounder-adjusted estimates of the risk difference are often difficult to obtain by direct regression adjustment. Estimates can be obtained from a propensity score-based method using inverse probability-of-exposure weights to balance groups defined by exposure status with respect to confounders. Simulation was used to evaluate the performance of this method. The simulation model incorporated a binary confounder and a normally distributed confounder into logistic models of exposure status, and disease status conditional on exposure status. Data were generated for combinations of values of several design parameters, including the odds ratio relating each of the confounders to exposure status, the odds ratio relating each of the confounders to disease status and the total sample size. For most design parameter combinations (474 of 486), the absolute bias in the estimated risk difference was less than 1 percentage point, and it was never greater than 3 percentage points. The confidence interval generally had close to nominal 95 per cent coverage, but was prone to poor coverage levels (as low as 78.5 per cent) when both the confounder-to-exposure and confounder-to-outcome odds ratios were 5, consistent with strong confounding. The simulation results showed that the conditions that are favourable for good performance of the weighting method are: reasonable overlap in the propensity score distributions of the exposed and non-exposed groups and a large sample size.

BACKGROUND: the reasons for increased birth defect prevalence following in-vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) are largely unknown. Classification of birth defects by pathology rather than organ system, and examination of the role of embryo freezing and thawing may provide clues to the mechanisms involved. This study aimed to investigate these two factors. METHOD: Data on 6946 IVF or ICSI singleton pregnancies were linked to perinatal outcomes obtained from population-based data sets on births and birth defects occurring between 1991 and 2004 in Victoria, Australia. These were compared with 20,838 outcomes for singleton births in the same population, conceived without IVF or ICSI. Birth defects were classified according to pathogenesis. RESULTS: Overall, birth defects were increased after IVF or ICSI [adjusted odds ratio (OR) 1.36; 95% CI: 1.19-1.55] relative to controls. There was no strong evidence of risk differences between IVF and ICSI or between fresh and thawed embryo transfer. However, a specific group, blastogenesis birth defects, were markedly increased [adjusted OR 2.80, 95% CI: 1.63-4.81], with the increase relative to the controls being significant for fresh embryo transfer (adjusted OR 3.65; 95% CI: 2.02-6.59) but not for thawed embryo transfer (adjusted OR 1.60; 95% CI: 0.69-3.69). CONCLUSION: Our findings suggest that there is a specific risk of blastogenesis birth defects arising very early in pregnancy after IVF or ICSI and that this risk may be lower with use of frozen-thawed embryo transfer.

BACKGROUND: Childhood obesity is associated with the early development of diseases such as type 2 diabetes and cardiovascular disease. Unfortunately, to date, traditional methods of research have failed to identify effective prevention and treatment strategies, and large numbers of children and adolescents continue to be at high risk of developing weight-related disease. AIM: to establish a unique 'biorepository' of data and biological samples from overweight and obese children, in order to investigate the complex 'gene × environment' interactions that govern disease risk. METHODS: the 'Childhood Overweight BioRepository of Australia' collects baseline environmental, clinical and anthropometric data, alongside storage of blood samples for genetic, metabolic and hormonal profiles. Opportunities for longitudinal data collection have also been incorporated into the study design. National and international harmonization of data and sample collection will achieve required statistical power. RESULTS: Ethical approval in the parent site has been obtained and early data indicate a high response rate among eligible participants (71%) with a high level of compliance for comprehensive data collection (range 56% to 97% for individual study components). Multi-site ethical approval is now underway. CONCLUSIONS: in time, it is anticipated that this comprehensive approach to data collection will allow early identification of individuals most susceptible to disease, as well as facilitating refinement of prevention and treatment programs.

OBJECTIVE: to quantify the contributions of child, family, and environmental predictors to language ability at 4 years. METHODS: a longitudinal study was performed with a sample of 1910 infants recruited at 8 months in Melbourne, Australia. Predictors were child gender, prematurity, birth weight and order, multiple birth, socioeconomic status, maternal mental health, vocabulary, education, and age at child's birth, non-English-speaking background, and family history of speech/language difficulties. Outcomes were Clinical Evaluation of Language Fundamentals-Preschool, language scores, low language status (scores >1.25 SDs below the mean), and specific language impairment (SLI) (scores >1.25 SDs below the mean for children with normal nonverbal performance). RESULTS: a total of 1596 children provided outcome data. Twelve baseline predictors explained 18.9% and 20.9% of the variation in receptive and expressive scores, respectively, increasing to 23.6% and 30.4% with the addition of late talking status at age 2. A total of 20.6% of children (324 of 1573 children) met the criteria for low language status and 17.2% (251 of 1462 children) for SLI. Family history of speech/language problems and low maternal education levels and socioeconomic status predicted adverse language outcomes. The combined predictors discriminated only moderately between children with and without low language levels or SLIs (area under the curve: 0.72-0.76); this improved with the addition of late talking status (area under the curve: 0.78-0.84). CONCLUSIONS: Measures of social disadvantage helped explain more variation in outcomes at 4 years than at 2 years, but ability to predict low language status and SLI status remained limited.

This study examines potential predictors of 'precocious talking' (expressive language ≥90th percentile) at one and two years of age, and of 'stability' in precocious talking across both time periods, drawing on data from a prospective community cohort comprising over 1,800 children. Logistic regression was used to examine the relationship between precocious talking and the following potential predictors: gender, birth order, birth weight, non-English speaking background, socioeconomic status, maternal age, maternal mental health scores, and vocabulary and educational attainment of parents. The strongest predictors of precocity (being female and having a younger mother) warrant further exploration. Overall, however, it appears that precocity in early vocabulary development is not strongly influenced by the variables examined, which together explained just 2.6% and 1% of the variation at 1;0 and 2;0 respectively.

This paper measures tobacco policies in statewide representative samples of secondary and mixed schools in Victoria, Australia and Washington, US (N = 3,466 students from 285 schools) and tests their association with student smoking. Results from confounder-adjusted random effects (multi-level) regression models revealed that the odds of student perception of peer smoking on school grounds are decreased in schools that have strict enforcement of policy (odds ratio (OR) = 0.45; 95% CI: 0.25 to 0.82; p = 0.009). There was no clear evidence in this study that a comprehensive smoking ban, harsh penalties, remedial penalties, harm minimization policy or abstinence policy impact on any of the smoking outcomes.

OBJECTIVE: to determine whether a structured programme of parent anticipatory guidance 'Toddlers Without Tears,' delivered in universal primary care, can prevent preschool child behaviour problems. DESIGN: Cluster randomised controlled trial. SETTING/PARTICIPANTS: 40 primary care nursing centres (clusters) in metropolitan Melbourne, Australia. 733 English-speaking mothers of 6- to 7-month-old infants consecutively recruited from well-child appointments; 589 (80%) retained at age 3 years. INTERVENTION: Parenting programme from age 8 to 15 months, with two group sessions co-led by well-child providers and a parenting expert. The programme addressed normal behaviour development and offered strategies to increase desired and reduce unwanted behaviour. While 93% of intervention parents received at least some of the programme, only 49% completed all components. Control Usual primary care. MAIN OUTCOME MEASURES: Maternal report of child externalising behaviour (Child Behaviour Checklist), parenting (Parent Behaviour Checklist) and maternal mental health (Depression Anxiety Stress Scales) when children were aged 3 years. RESULTS: Behaviour scores in the intervention and control groups were similar (mean (SD)) 11.4 (7.1) versus 12.4 (7.6); adjusted mean difference -0.8, 95% CI -2.2 to 0.6, p=0.26). On the parenting subscale scores, intervention parents reported fewer unreasonable expectations of child development (37.3 (10.9) vs 39.9 (10.2), adjusted mean difference -3.1, 95% CI -4.9 to -1.4, p=0.001). The mean scores for harsh/abusive and nurturing parenting, and maternal mental health, were similar between the two groups. CONCLUSIONS: a brief universal parenting programme in primary care is insufficient to prevent development of preschool externalising problems. A new population trial targeting more intensive prevention to distressed parents with toddler behaviour problems is now under way, aiming to prevent externalising and internalising problems before school entry. TRIAL REGISTRATION NUMBER: ISRCTN77531789.

Newborn screening (NBS) for cystic fibrosis (CF) provides the opportunity for cascade carrier testing of relatives. Uptake of testing by adult non-parent relatives of children diagnosed with CF through NBS has not been previously described, and this study describes uptake by both parents and adult non-parent relatives in Victoria, Australia. Pedigrees were taken from parents of children who were born in 2000-2004 and diagnosed with CF. A total of 40 families were eligible for the study and 30 (75%) were recruited. In all, 716 non-parent relatives were identified from the pedigrees as eligible for carrier testing, and 82 (adjusted uptake percentage: 11.8%; 95% confidence interval 8.0-15.7) have had carrier testing by March 2009. On average, 2.7 non-parent relatives per family had CF carrier testing after diagnosis through NBS. The odds of being tested were greater for females than males (adjusted odds ratio 1.61; 95% confidence interval 1.11-2.33; P=0.01) and greater for those more closely related to the child with CF (adjusted odds ratio 5.17; 95% confidence interval 2.38-11.24; P

OBJECTIVES: This study aimed to describe the application, feasibility and outcomes of using simulated patients (SPs) to increase the skills of general practitioners (GPs) delivering a behavioural intervention to reduce childhood overweight and mild obesity. METHODS: Five female actors were trained as SPs. A total of 67 GPs from 46 general practices in Melbourne, Victoria, Australia, conducted two simulated consultation visits regarding healthy lifestyle family behaviour change, during which they practised their skills and received formative feedback. The GPs and SPs rated GP performance immediately after each consultation. Subsequently, 139 parents of overweight or obese 5-9-year-old children rated GP performance during real-life consultations. Other measures included child body mass index (BMI) Z-scores (at baseline and at a 9-month follow-up) and GP-reported levels of comfort and competence and the perceived value of SP visits. RESULTS: Simulated patient ratings, but not GP self-ratings, of GP performance predicted both parent ratings of real-life consultations (Spearman's rho 0.39 for correlation with SP rating at Visit 1) and subsequent reductions in BMI Z-scores between baseline and follow-up (Visit 1, rho-0.45; Visit 2, rho-0.46). GP levels of comfort and competence were maintained during and after the SP visits. A total of 95% of GPs rated simulated consultations as useful, although only 18% said they would pay for them. CONCLUSIONS: Simulated patient assessment may predict real patient feedback and clinical outcomes, helping to identify doctors who require further training in behaviour change techniques. Randomised controlled trials may establish whether SPs actually raise skills or improve outcomes.

OBJECTIVE: to examine how fitness in both childhood and adulthood is associated with adult obesity and insulin resistance. RESEARCH DESIGN AND METHODS: a prospective cohort study set in Australia in 2004-2006 followed up a cohort of 647 adults who had participated in the Australian Schools Health and Fitness Survey in 1985 and who had undergone anthropometry and cardiorespiratory fitness assessment during the survey. Outcome measures were insulin resistance and obesity, defined as a homeostasis model assessment index above the 75th sex-specific percentile and BMI >or=30 kg/m(2), respectively. RESULTS: Lower levels of child cardiorespiratory fitness were associated with increased odds of adult obesity (adjusted odds ratio [OR] per unit decrease 3.0 [95% CI 1.6-5.6]) and insulin resistance (1.7 [1.1-2.6]). A decline in fitness level between childhood and adulthood was associated with increased obesity (4.5 [2.6-7.7]) and insulin resistance (2.1 [1.5-2.9]) per unit decline. CONCLUSIONS: a decline in fitness from childhood to adulthood, and by inference a decline in physical activity, is associated with obesity and insulin resistance in adulthood. Programs aimed at maintaining high childhood physical activity levels into adulthood may have potential for reducing the burden of obesity and type 2 diabetes in adults.

Objective: to determine whether ascertainment of childhood obesity by surveillance followed by structured secondary prevention in primary care improved outcomes in overweight or mildly obese children. Design: Randomised controlled trial nested within a baseline cross sectional survey of body mass index (BMI). Randomisation and outcomes measurement, but not participants, were blinded to group assignment. Setting: 45 family practices (66 general practitioners) in Melbourne, Australia. Participants: 3958 children visiting their general practitioner in May 2005-July 2006 were surveyed for BMI. of these, 258 children aged 5 years 0 months up to their 10th birthday who were overweight or obese by International Obesity Taskforce criteria were randomised to intervention (n=139) or control (n=119) groups. Children who were very obese (UK BMI z score ≥3.0) were excluded. Intervention: Four standard consultations over 12 weeks targeting change in nutrition, physical activity, and sedentary behaviour, supported by purpose designed family materials. Main outcomes measures: Primary measure was BMI at 6 and 12 months after randomisation. Secondary measures were mean activity count/min by 7-day accelerometry, nutrition score from 4-day abbreviated food frequency diary, and child health related quality of life. Differences were adjusted for socioeconomic status, age, sex, and baseline BMI. Results: of 781 eligible children, 258 (33%) entered the trial; attrition was 3.1% at 6 months and 6.2% at 12 months. Adjusted mean differences (intervention - control) at 6 and 12 months were, for BMI, -0.12 (95% CI -0.40 to 0.15, P=0.4) and -0.11 (-0.45 to 0.22, P=0.5); for physical activity in counts/min, 24 (-4 to 52, P=0.09) and 11 (-26 to 49, P=0.6); and, for nutrition score, 0.2 (-0.03 to 0.4, P=0.1) and 0.1 (-0.1 to 0.4, P=0.2). There was no evidence of harm to the child. Costs to the healthcare system were significantly higher in the intervention arm. Conclusions: Primary care screening followed by brief counselling did not improve BMI, physical activity, or nutrition in overweight or mildly obese 5-10 year olds, and it would be very costly if universally implemented. These findings are at odds with national policies in countries including the US, UK, and Australia. Trial registration: ISRCTN 52511065 (www.isrctn.org).

To determine whether ascertainment of childhood obesity by surveillance followed by structured secondary prevention in primary care improved outcomes in overweight or mildly obese children.

OBJECTIVES: Our goals were to document (1) the onset of stuttering and (2) whether specific child, family, or environmental factors predict stuttering onset in children aged up to 3 years. METHODS: Participants included a community-ascertained cohort of 1619 2-year-old Australian children recruited at 8 months of age to study the longitudinal development of early language. The main outcome measure was parental telephone report of stuttering onset, verified by face-to-face expert diagnosis. Preonset continuous measures of the child's temperament (approach/withdrawal) and language development were available. Information on a range of predictor measures hypothesized to be associated with stuttering onset was obtained (maternal mental health and education levels, gender, premature birth status, birth weight, birth order, twinning, socioeconomic status, family history of stuttering). RESULTS: By 3 years of age, the cumulative incidence of stuttering onset was 8.5%. Onset often occurred suddenly over 1 to 3 days (49.6%) and involved the use of word combinations (97.1%). Children who stuttered were not more shy or withdrawn. Male gender, twin birth status, higher vocabulary scores at 2 years of age, and high maternal education were associated with stuttering onset. The multivariable model, however, had low predictive strength; just 3.7% of the total variation in stuttering onset was accounted for. CONCLUSIONS: the cumulative incidence of stuttering onset was much higher than reported previously. The hypothesized risk factors for stuttering onset together explained little of the variation in stuttering onset up to 3 years of age. Early onset was not associated with language delay, social and environmental factors, or preonset shyness/withdrawal. Health professionals can reassure parents that onset is not unusual up to 3 years of age and seems to be associated with rapid growth in language development.

Background : Multiple sclerosis has a variable disease course. The contribution of modifiable lifestyle factors to disease course has not been well studied, although one cohort has reported that smoking is associated with conversion to secondary progressive MS course and another that smoking is not. Methods : We conducted a prospective cohort study of people with MS in Southern Tasmania from 2002 to 2004 with 78 % (203/259) of eligible participating and 198 with one or more reviews and confirmed MS. The cohort had a high retention rate (90 % (183/203)). The median follow- up time was 909 days. Smoking data were collected at baseline and six-monthly reviews. Clinical disability assessments were conducted annually in conjunction with a real time clinical notification system for relapses. A repeated measures analysis and other statistical methods were used. Results : Cumulative pack-years (p-y) smoked after cohort entry was associated with an increase in longitudinal MSSS (p < 0.001). Relative to the 0 pack years (p-y) category (in the year prior to the MSSS measure) those in the 0 to 1 p-y category had an adjusted mean difference in MSSS of 0.34 (95 % CI 0.28, 0.66); those in the 1 to 2 p-y category had a 0.41 (95 % CI -0.03, 0.85) increase; and those in the 2 or more p-y category had a 0.99 (95 % CI 0.41, 1.58) increase in MSSS. Similar results were found using a variety of statistical approaches or EDSS as a clinical outcome. Smoking during the cohort period was not associated with relapse (cumulative pack years smoked after cohort entry, HR 0.94 (0.69, 1.26) per pack year). Conclusion : a better understanding of the mechanisms underlying smoking and multiple sclerosis, particularly progressive forms of the disease, may provide new insights for the eventual goal of better treatment and prevention of multiple sclerosis. © 2009 Steinkopff-Verlag.

The aim of this paper is to provide an overview of the methods and preliminary findings from the Early Language in Victoria Study (ELVS) a prospective, longitudinal study of child language impairment. Specifically, we provide a summary of early communication and vocabulary development and examine the contributions a range of risk factors and predictors make to these outcomes. The sample was a community-ascertained cohort of 1911 infants, recruited at 8 months and followed at ages 12 and 24 months. The main outcomes of interest were parent reported infant and toddler communication (Communication and Symbolic Behavior Scales, CSBS) and expressive vocabulary (MacArthur-Bates Communicative Development Inventories, CDI). Predictors included gender, preterm birth, birth weight, multiple birth, birth order, socioeconomic status, maternal mental health, maternal vocabulary and education, maternal age at birth of child, nonEnglish-speaking background, and a family history of speech andor language difficulties. Results demonstrated rapid development in communication skills measured by the three CSBS domains (social, speech and symbolic) and in vocabulary development (CDI). There was rapid growth in gesture use between 8 and 12 months and symbolic use of objects between 12 to 24 months. At approximately 24 months, 19.7% had delayed expressive vocabulary. Male gender and family history were associated with poorer outcomes on the CSBS and the CDI at 8, 12 and 24 months, although the regression models explained only a small amount of the variance in outcome. In summary we measured rapid growth in communication skills and vocabulary between 12 and 24 months, but the hypothesized early risk factors and predictors explained little of the variation in these outcomes. We conclude that the risk factorspredictors examined in this study therefore seem unlikely to be helpful in screening for early language delay.

The intra-cluster correlation coefficient (ICC) of the primary outcome plays a key role in the design and analysis of cluster randomized trials (CRTs), but the precise definition of this parameter is somewhat elusive, especially in the context of non-normally distributed outcomes. In this paper, we provide a unified treatment of ICC as used in CRTs. We present a general definition of the ICC that may be expressed in different ways depending on the modelling approach used to describe the data, illustrating how this general definition is applied to continuous and dichotomous outcomes. Greater complexity arises for dichotomous outcomes; in particular, the usual definition of the ICC cannot be related directly to the parameters of the logistic-normal model that is commonly used for dichotomous outcomes. We show how the definition of the ICC is different when covariates are introduced. Finally, we use our framework and definition of the ICC to draw out implications for those interpreting and choosing values of the ICC when planning CRTs. © 2009 International Statistical Institute.

This paper evaluates methods for unadjusted analyses of binary outcomes in cluster randomized trials (CRTs). Under the generalized estimating equations (GEE) method the identity, log and logit link functions may be specified to make inferences on the risk difference, risk ratio and odds ratio scales, respectively. An alternative, 'cluster-level', method applies the t-test to summary statistics calculated for each cluster, using proportions, log proportions and log odds, to make inferences on the respective scales. Simulation was used to estimate the bias of the unadjusted intervention effect estimates and confidence interval coverage, generating data sets with different combinations of number of clusters, number of participants per cluster, intra-cluster correlation coefficient rho and intervention effect. When the identity link was specified, GEE had little bias and good coverage, performing slightly better than the log and logit link functions. The cluster-level method provided unbiased point estimates when proportions were used to summarize the clusters. When the log proportion and log odds were used, however, the method often had markedly large bias for two reasons: (i) bias in the modified summary statistic used for cluster-level estimation when a cluster has zero cases with the outcome of interest (arising when the number of participants sampled per cluster is small and the outcome prevalence is low) and (ii) asymptotically, the method estimates the ratio of geometric means of the cluster proportions or odds, respectively, between the trial arms rather than the ratio of arithmetic means.

OBJECTIVE: the right ventricle in hypoplastic left heart syndrome (HLHS) works at systemic pressure and large volume loading before and after first stage palliation. There is a paucity of information regarding the intrinsic characteristics of the right ventricle in HLHS. We studied extra-cellular matrix composition, myocyte homeostasis and gene expression in right ventricular biopsies obtained from patients with HLHS undergoing neonatal first stage palliation and from patients undergoing neonatal truncus arteriosus repair. METHODS: Tissue was evaluated using histological and real-time PCR techniques using the truncus group as a comparative group. Mean difference in outcomes between the HLHS and truncus groups was estimated using linear regression models in unadjusted and age-adjusted analyses. RESULTS: Markers of cell proliferation, apoptosis and fibronectin were significantly higher in the right ventricular myocardium of patients with hypoplastic left heart syndrome compared to truncus arteriosus. Type I collagen content and NKX2.5 expression were significantly lower in HLHS than the truncus group. CONCLUSION: the neonatal right ventricle in HLHS demonstrates a number of intrinsic differences compared to the right ventricle in truncus arteriosus including relative immaturity of the extra-cellular matrix, inappropriately low transcription factor expression and increased myocyte apoptosis.

BACKGROUND: Mental health problems comprise an international public health issue affecting up to 20% of children and show considerable stability. We aimed to identify child, parenting, and family predictors from infancy in the development of externalising and internalising behaviour problems by age 3 years. METHODS: Design Longitudinal, population-based survey completed by primary caregivers when children were 7, 12, 18, 24 and 36 months old. Participants 733 children sequentially recruited at 6-7 months from routine well-child appointments (August-September 2004) across six socio-economically and culturally diverse government areas in Victoria, Australia; 589 (80%) retained at 3 years. Measures 7 months: sociodemographic characteristics, maternal mental health (Depression Anxiety Stress Scale (DASS)), substance misuse, home violence, social isolation, infant temperament; 12 months: partner relationship, parenting (Parent Behavior Checklist (PBC)); 18, 24 and 36 months: child behaviour (Child Behavior Checklist 1(1/2)-5 (CBCL)), PBC, DASS. RESULTS: Sixty-nine percent of all families attending well-child clinics took part. The consistent and cumulative predictors of externalising behaviours were parent stress and harsh discipline. Predictors of internalising behaviours included small family size, parent distress, and parenting. Twenty-five percent of variation in early externalising behaviour and 17% of variation in early internalising behaviour was explained. CONCLUSIONS: Effective and cost-efficient population approaches to preventing mental health problems early in childhood are urgently needed. Programmes must support parents in reducing personal stress as well as negative parenting practices.

OBJECTIVES: Maternal depression is an established risk for adverse child development. Two thirds of clinically significant depressive symptoms occur in mothers reporting an infant sleep problem. We aimed to determine the long-term effects of a behavioral intervention for infant sleep problems on maternal depression and parenting style, as well as on child mental health and sleep, when the children reached 2 years of age. METHODS: We conducted a cluster-randomized trial in well-child centers across 6 government areas of Melbourne, Australia. Participants included 328 mothers reporting an infant sleep problem at 7 months, drawn from a population sample (N = 739) recruited at 4 months. We compared the usual well-child care (n = 154) versus a brief behavior-modification program designed to improve infant sleep (n = 174) delivered by well-child nurses at ages 8 to 10 months and measured maternal depression symptoms (Edinburgh Postnatal Depression Scale); parenting practices (Parent Behavior Checklist); child mental health (Child Behavior Checklist); and maternal report of a sleep problem (yes or no). RESULTS: at 2 years, mothers in the intervention group were less likely than control mothers to report clinical depression symptoms: 15.4% vs 26.4% (Edinburgh Postnatal Depression Scale community cut point) and 4.2% vs 13.2% (Edinburgh Postnatal Depression Scale clinical cut point). Neither parenting style nor child mental health differed markedly between the intervention and control groups. A total of 27.3% of children in the intervention group versus 32.6% of control children had a sleep problem. CONCLUSIONS: the sleep intervention in infancy resulted in sustained positive effects on maternal depression symptoms and found no evidence of longer-term adverse effects on either mothers' parenting practices or children's mental health. This intervention demonstrated the capacity of a functioning primary care system to deliver effective, universally offered secondary prevention.

The Macarthur-Bates Communicative Development Inventories (CDI) have been used widely to document early communicative development. The paper reports on a large community sample of 1,447 children recruited from low, middle and high socioeconomic (SES) areas across metropolitan Melbourne, Australia. Regression analyses were conducted to determine the extent to which communicative behaviours reported at 0 ; 8 and 1 ; 0 predicted vocabulary development at 1 ; 0 and 2 ; 0. In support of previous findings with smaller, often less representative samples, gesture and object use at 1 ; 0 were better predictors of 2 ; 0 vocabulary than were gesture and object use at 0 ; 8. At 1 ; 0, children from the lower SES groups were reported to understand more words than children from the higher SES groups, but there were no SES differences for words produced at 1 ; 0 or 2 ; 0. The findings add to our understanding of the variability in the development of early communicative behaviours.

OBJECTIVE: to determine whether a parenting programme, offered universally in primary care, can prevent behavioural problems in children and improve parenting and maternal mental health. DESIGN: Cluster randomised trial. SETTING: 40 primary care nursing centres (clusters) in Victoria, Australia. PARTICIPANTS: 733 English speaking mothers of 8 month old children sequentially recruited from well child appointments; 656 retained at 24 months. INTERVENTION: Structured three session programme at age 8-15 months, co-led by well child providers and a parenting expert. The programme covered normal development and behaviour, strategies to increase desired behaviour, and strategies to reduce unwanted behaviour. MAIN OUTCOME MEASURES: Maternal report of child externalising behaviour (child behavior checklist 1(1/2)-5 year old), parenting (parent behavior checklist), and maternal mental health (depression anxiety stress scales) at 18 and 24 months. RESULTS: at 18 months, child behaviour and parenting scores were similar in the two groups. At 24 months, externalising scores in the intervention and control groups were similar (mean 11.9 (SD 7.2) v 12.9 (7.4)); however, on the parent behavior checklist subscale scores, intervention group parents were less likely to report harsh/abusive parenting (mean 38.9 (SD 7.7) v 40.5 (8.8); adjusted mean difference -1.83, 95% confidence interval -3.12 to -0.55) and unreasonable expectations of child development (40.9 (9.9) v 42.7 (9.6); -2.18, -3.74 to -0.62). Mean scores for nurturing parenting and maternal mental health were similar in the two groups at both times. CONCLUSIONS: a universal parenting programme resulted in modest improvement in parenting factors that predict behavioural problems in children but did not reduce externalising behavioural problems or affect maternal mental health at 2 years. Trial registration ISRCTN 77531789.

OBJECTIVE: to evaluate the effectiveness of a decision aid for prenatal testing of fetal abnormalities compared with a pamphlet in supporting women's decision making. DESIGN: a cluster randomised controlled trial. SETTING: Primary health care. POPULATION: Women in early pregnancy consulting a GP. METHODS: GPs were randomised to provide women with either a decision aid or a pamphlet. The decision aid was a 24-page booklet designed using the Ottowa Decision Framework. The pamphlet was an existing resource available in the trial setting. MAIN OUTCOME MEASURES: Validated scales were used to measure the primary outcomes, informed choice and decisional conflict, and the secondary outcomes, anxiety, depression, attitudes to the pregnancy/fetus and acceptability of the resource. Outcomes were measured at 14 weeks of gestation from questionnaires that women completed and returned by post. FINDINGS: Women in the intervention group were more likely to make an informed decision 76% (126/165) than those in the control group 65% (107/165) (adjusted OR 2.08; 95% CI 1.14-3.81). A greater proportion of women in the intervention group 88% (147/167) had a 'good' level of knowledge than those in the control group 72% (123/171) (adjusted OR 3.43; 95% CI 1.79-6.58). Mean (SD) decisional conflict scores were low in both groups, decision aid 1.71 (0.49), pamphlet 1.65 (0.55) (adjusted mean difference 0.10; 95% CI -0.02 to 0.22). There was no strong evidence of differences between the trial arms in the measures of psychological or acceptability outcomes. CONCLUSION: a tailored prenatal testing decision aid plays an important role in improving women's knowledge of first and second trimester screening tests and assisting them to make decisions about screening and diagnostic tests that are consistent with their values.

We used simulation to compare accuracy of estimation and confidence interval coverage of several methods for analysing binary outcomes from cluster randomized trials. The following methods were used to estimate the population-averaged intervention effect on the log-odds scale: marginal logistic regression models using generalized estimating equations with information sandwich estimates of standard error (GEE); unweighted cluster-level mean difference (CL/U); weighted cluster-level mean difference (CL/W) and cluster-level random effects linear regression (CL/RE). Methods were compared across trials simulated with different numbers of clusters per trial arm, numbers of subjects per cluster, intraclass correlation coefficients (rho), and intervention versus control arm proportions. Two thousand data sets were generated for each combination of design parameter values. The results showed that the GEE method has generally acceptable properties, including close to nominal levels of confidence interval coverage, when a simple adjustment is made for data with relatively few clusters. CL/U and CL/W have good properties for trials where the number of subjects per cluster is sufficiently large and rho is sufficiently small. CL/RE also has good properties in this situation provided a t-distribution multiplier is used for confidence interval calculation in studies with small numbers of clusters. For studies where the number of subjects per cluster is small and rho is large all cluster-level methods may perform poorly for studies with between 10 and 50 clusters per trial arm.

OBJECTIVE: in contrast to school-aged children, the impact of sleep problems in preschool-aged children is not well documented. We aimed to determine relationships between preschool-aged child sleep problems and child behavior; health-related quality of life; verbal, preliteracy, and early numeracy skills; diagnosis of attention-deficit/hyperactivity disorder; and injury. PARTICIPANTS AND METHODS: Participants included families (n = 4983) participating in the first wave of the Longitudinal Study of Australian Children, a nationally representative study of Australian children aged 4 to 5 years surveyed from March to November 2004. Measures consisted of a primary caregiver's report of whether their child had a sleep problem (none versus mild versus moderate/severe); specific sleep patterns occurring > or = 4 nights per week; health-related quality of life (by using the Pediatric Quality of Life Inventory 4.0); behavior (by using the Strengths and Difficulties Questionnaire) and parent-reported diagnosis of attention-deficit/hyperactivity disorder; and injury requiring medical attention in the past 12 months. Tests of receptive vocabulary and preliteracy/numeracy skills (by using the Who Am I? developmental assessment and the adapted Peabody Picture Vocabulary Test, 3rd Edition) were directly administered to each child. RESULTS: Sleep problems were common, and compared with children without sleep problems, children with sleep problems had poorer child health-related quality of life, more behavior problems, and higher rates of attention-deficit/hyperactivity disorder. Difficulty going to sleep and morning tiredness had greater adverse associations than snoring or night waking. CONCLUSIONS: Given that sleep problems are very common, the adverse outcomes shown here could affect the transition to school for a very large number of preschoolers.

The aim of this study is to assess the potential effectiveness, acceptability and feasibility of a brief smoking cessation intervention delivered as part of cervical screening. A cluster randomised controlled trial was conducted with clinic week as the unit of randomisation, comparing a group (n=121) receiving brief smoking cessation advice supplemented with written information given by practice nurses during cervical smear test appointments, with a group (n=121) not receiving this advice. Outcomes were intention to stop smoking (potential effectiveness); intention to attend for future cervical screening (acceptability); duration of intervention (feasibility). 172/242 (71%) and 153/242 (63%) participants completed 2-week and 10-week follow-ups, respectively. Compared to women in the control group, those in the intervention group had higher intentions to stop smoking at 2-weeks (adjusted mean difference 0.51, 95% CI: -0.02 to 1.03, P=0.06) and 10-weeks (adjusted mean difference 0.80, 95% CI 0.10 to 1.50, P=0.03). The two groups had similarly high intentions to attend for future screening. Consultations in the intervention arm took a mean of 4.98 min (95% CI: 3.69 to 6.27; P

OBJECTIVES: to determine whether a community-delivered intervention targeting infant sleep problems improves infant sleep and maternal well-being and to report the costs of this approach to the healthcare system. DESIGN: Cluster randomised trial. SETTING: 49 Maternal and Child Health (MCH) centres (clusters) in Melbourne, Australia. PARTICIPANTS: 328 mothers reporting an infant sleep problem at 7 months recruited during October-November 2003. INTERVENTION: Behavioural strategies delivered over individual structured MCH consultations versus usual care. MAIN OUTCOME MEASURES: Maternal report of infant sleep problem, depression symptoms (Edinburgh Postnatal Depression Scale (EPDS)), and SF-12 mental and physical health scores when infants were 10 and 12 months old. Costs included MCH sleep consultations, other healthcare services and intervention costs. RESULTS: Prevalence of infant sleep problems was lower in the intervention than control group at 10 months (56% vs 68%; adjusted OR 0.58 (95% CI: 0.36 to 0.94)) and 12 months (39% vs 55%; adjusted OR 0.50 (0.31 to 0.80)). EPDS scores indicated less depression at 10 months (adjusted mean difference -1.4 (-2.3 to -0.4) and 12 months (-1.7 (-2.6 to -0.7)). SF-12 mental health scores indicated better health at 10 months (adjusted mean difference 3.7 (1.5 to 5.8)) and 12 months (3.9 (1.8 to 6.1)). Total mean costs including intervention design, delivery and use of non-MCH nurse services were 96.93 pounds sterling and 116.79 pounds sterling per intervention and control family, respectively. CONCLUSIONS: Implementing this sleep intervention may lead to health gains for infants and mothers and resource savings for the healthcare system. TRIAL REGISTRATION: Current Controlled Trial Registry, number ISRCTN48752250 [controlled-trials.com] (registered November 2004).

OBJECTIVES: to reduce gain in body mass index (BMI) in overweight/mildly obese children in the primary care setting. DESIGN: Randomized controlled trial (RCT) nested within a baseline cross-sectional BMI survey. SETTING: Twenty nine general practices, Melbourne, Australia. PARTICIPANTS: (1) BMI survey: 2112 children visiting their general practitioner (GP) April-December 2002; (2) RCT: individually randomized overweight/mildly obese (BMI z-score

OBJECTIVE: This article responds to evidence gaps regarding language impairment identified by the US Preventive Services Task Force in 2006. We examine the contributions of putative child, family, and environmental risk factors to language outcomes at 24 months of age. METHODS: a community-ascertained sample of 1720 infants who were recruited at 8 months of age were followed at ages 12 and 24 months in a prospective, longitudinal study in metropolitan Melbourne, Australia. Outcomes at 24 months were parent-reported infant communication (Communication and Symbolic Behavior Scales and MacArthur-Bates Communicative Development Inventories vocabulary production score). Putative risk factors were gender, preterm birth, birth weight, multiple birth, birth order, socioeconomic status, maternal mental health, maternal vocabulary and education, maternal age at birth of child, non-English-speaking background, and family history of speech-language difficulties. Linear regression models were fitted to total standardized Communication and Symbolic Behavior Scales and Communicative Development Inventories vocabulary production scores; a logistic regression model was fitted to late-talking status at 24 months. RESULTS: the regression models accounted for 4.3% and 7.0% of the variation in the 24-month Communication and Symbolic Behavior Scales and Communicative Development Inventories scores, respectively. Male gender and family history were strongly associated with poorer outcomes on both instruments. Lower Communication and Symbolic Behavior Scales scores were also associated with lower maternal vocabulary and older maternal age. Lower vocabulary production scores were associated with birth order and non-English-speaking background. When the 12-month Communication and Symbolic Behavior Scales Total score was added as a covariate in the linear regression of 24-month Communication and Symbolic Behavior Scales Total score, it was by far the strongest predictor. CONCLUSIONS: These early risk factors explained no more than 7% of the variation in language at 24 months. They seem unlikely to be helpful in screening for early language delay.

BACKGROUND AND OBJECTIVE: Mental health problems are a public health issue affecting as many as 20% of children in modern communities. Risk factors for externalising and internalising problems can occur in infancy. Infants at high risk live in stressed families with parent mental health problems, substance misuse, relationship conflict, social isolation, financial problems or infant temperamental difficulty. Although current prevention programmes target services to high-risk groups, targeting can stigmatise families and miss many children in need. The addition of universal prevention programmes for all families could address these concerns. This survey assessed the prevalence of infants at risk attending a primary care service as a delivery point for universal prevention. DESIGN: Survey of mothers of 6-month-old infants attending well-child clinics across six government areas of Melbourne, Victoria, Australia, between August and September 2004. A brief survey measured sociodemographic characteristics and the following family risks: maternal depression, anxiety, stress, substance misuse, violence at home, social isolation and infant temperamental difficulty. RESULTS: the survey was completed by 733 mothers, representing 69% of infant births presented to the primary care service. of these, 39% of infants were classified as at risk for developing mental health problems. The percentage of infants classified as at risk was not markedly dissimilar across socioeconomic levels (low, 42%; middle, 40%; high, 35%). CONCLUSIONS: a substantial number of infants attending routine universal primary care are at risk of developing mental health problems. This primary care setting could provide an ideal platform for preventing early externalising and internalising problems via a universally offered, evidence-based parenting programme.

OBJECTIVE: to examine the extent to which excessive drinking in young adults is associated with alcohol abuse and dependence. METHOD: Cross-sectional analyses were conducted using data from the eighth wave of the Victorian Adolescent Health Cohort Study, which comprised 1943 Victorians currently aged 24-25 years drawn from 44 secondary schools across the state in 1992. The main outcome measures of interest were short-term risk drinking status (based on daily alcohol consumption) and long-term risk drinking status (based on total weekly alcohol consumption). RESULTS: Two out of 5 participants drank at moderate to high risk levels for short-term harm. Yet, because young people tend to drink on only 1-2 days a week, fewer (22%) were at moderate to high risk for long-term harm. Although 20% of the participants met criteria for a diagnosis of alcohol abuse or dependence, most of those in the moderate- to high-risk drinking categories were not diagnosed with either alcohol disorder. CONCLUSION: Excessive alcohol use in one or two sessions a week appears to be common in young Australian adults. While short- and long-term risky drinking is more common in those with an alcohol use disorder, the majority of moderate- and high-risk drinking is done by those who do not meet criteria for an alcohol use disorder.

BACKGROUND: to fully assess predictive genetic testing programs, it is important to assess outcomes over periods of time longer than the 1-year follow-up reported in the literature. METHODS: We conducted a 3-year study of individuals who received predictive genetic test results for previously identified familial mutations in Australian Familial Cancer Clinics. Questionnaires were sent before attendance at the familial cancer clinic and 2 weeks, 4 months, 1 year, and 3 years after receiving test results. Psychological measures were included each time, and preventive behaviors were assessed at baseline and 1 and 3 years. Psychological measures were adjusted for age, gender, and baseline score. RESULTS: the study included 19 carriers and 54 non-carriers. We previously reported an increase in mean cancer-specific distress in carriers at 2 weeks with a return to baseline levels by 12 months. This level was maintained until 3 years. Non-carriers showed sustained decreases after testing with a significantly lower level at 3 years compared with baseline (P < 0.001). These scores tended to be lower than those for carriers at 3 years (P = 0.09). Mean depression and anxiety scores did not differ between carriers and non-carriers and, at 3 years, were similar to baseline. All carriers and 7% of non-carriers had had a colonoscopy by 3 years, and 69% of 13 female carriers had undergone gynecological screening in the previous 2 years. Prophylactic surgery was rare. CONCLUSION: This report of long-term data indicates appropriate screening and improved psychological measures for non-carriers with no evidence of undue psychological distress in carriers of hereditary nonpolyposis colorectal cancer mutations.

PURPOSE: Data on the process of mental health care is scant. Most studies focus on services at their inception when activity may be atypical and then usually present data only mean values for the reported variables over the whole study period. We aimed to test whether care delivery changes over time, and to describe any changes at the individual patient and team levels. METHODS: Process data on 272 patients in three new intensive case management (ICM) teams were collected over 2 years. Interventions were prospectively recorded using clinician-derived categories. Changes over time are described at both patient and team level. RESULTS: the number of contacts and the proportion of face-to-face activity were remarkably constant after the first month at the patient level. The proportion of 'psychiatric' interventions (main focus on medication or a specific 'mental health' intervention performed) increased greatly after the first 6 months. The care activity received by individual patients varied considerably. Overall, teams varied significantly in the extent to which their activity rates were sustained over time. CONCLUSIONS: New ICM teams deliver highly individualised care with more marked differences in treatment patterns between patients in the same team than mean differences between teams. The early 'engagement' period is marked by a greater focus on social care. There is evidence of differences in sustainability of the services by site.

AIM: to describe changes in infant prelinguistic communication skills between 8 and 12 months, and identify factors associated with those skills. DESIGN: Parent questionnaire data for a prospective population-based cohort of infants in metropolitan Melbourne, Australia. PARTICIPANTS: 1911 infants born November 2002-August 2003. OUTCOME: Infant communication (Communication and Symbolic Behaviour Scales (CSBS)) at 8 and 12 months. Potential risk factors: sex; prematurity; multiple birth; sociodemographic indicators; maternal mental health, vocabulary and education; non-English speaking background; and family history of speech-language difficulties. Linear regression models were fitted to total standardised CSBS scores at 8 and 12 months. RESULTS: Social communication, especially the use of gesture, developed rapidly from 8 to 12 months. Female sex, twin birth, and family history were strongly associated with CSBS scores. The combined model accounted for 5% and 6% of the total variation at 8 and 12 months, respectively. CSBS score at 8 months strongly predicted CSBS score at 12 months (coefficient = 0.56, partial R(2) = 37.0). CONCLUSIONS: There is a dramatic increase in communication skills between 8 and 12 months, particularly the development of gesture, which (as in previous studies) predates and predicts future language development. Risk factors explained little variation in early communication trajectories and therefore, based on our findings, this developmental course is more likely to be biologically predetermined. Rather than focusing on risk factors, we suggest that language promotion activities in otherwise healthy young infants should either be universal or, if targeted, be based on the level of communication skills displayed.

Pneumothorax is a known complication in cystic fibrosis (CF), associated with poor outcome. Records of CF patients with pneumothorax at the Royal Children's Hospital, Melbourne between 1990 and 2004 were reviewed, and the characteristics, sputum culture results, lung function, treatment, and outcome for the 11 patients who had pneumothoraces were described.

OBJECTIVE: the goal was to determine the prevalence and effects of slight/mild bilateral sensorineural hearing loss among children in elementary school. METHODS: a cross-sectional, cluster-sample survey of 6581 children (response: 85%; grade 1: n = 3367; grade 5: n = 3214) in 89 schools in Melbourne, Australia, was performed. Slight/mild bilateral sensorineural hearing loss was defined as a low-frequency pure-tone average across 0.5, 1, and 2 kHz and/or a high-frequency pure-tone average across 3, 4, and 6 kHz of 16 to 40 dB hearing level in the better ear, with air/bone-conduction gaps of < 10 dB. Parents reported children's health-related quality of life and behavior. Each child with slight/mild bilateral sensorineural hearing loss, matched to 2 normally hearing children (low-frequency pure-tone average and high-frequency pure-tone average of < or = 15 dB hearing level in both ears), completed standardized assessments. Whole-sample comparisons were adjusted for type of school, grade level, and gender, and matched-sample comparisons were adjusted for nonverbal IQ scores. RESULTS: Fifty-five children (0.88%) had slight/mild bilateral sensorineural hearing loss. Children with and without sensorineural hearing loss scored similarly in language (mean: 97.2 vs 99.7), reading (101.1 vs 102.8), behavior (8.4 vs 7.0), and parent- and child-reported child health-related quality of life (77.6 vs 80.0 and 76.1 vs 77.0, respectively), but phonologic short-term memory was poorer (91.0 vs 102.8) in the sensorineural hearing loss group. CONCLUSIONS: the prevalence of slight/mild bilateral sensorineural hearing loss was lower than reported in previous studies. There was no strong evidence that slight/mild bilateral sensorineural hearing loss affects adversely language, reading, behavior, or health-related quality of life in children who are otherwise healthy and of normal intelligence.

BACKGROUND AND OBJECTIVE: to describe the association between values for a proportion and the intraclass correlation coefficient (ICC). METHODS: Analysis of data obtained from the General Practice Research Database (GPRD) for variation between United Kingdom general practices and results from a Health Technology Assessment (HTA) review for a range of outcomes in community and health services settings. RESULTS: There were 188 ICCs from the GPRD, the median prevalence was 13.1% (interquartile range IQR 3.5 to 28.4%) and median ICC 0.051 (IQR 0.011 to 0.094). There were 136 ICCs from the HTA review, with median prevalence 6.5% (IQR 0.4 to 20.7%) and median ICC 0.006 (IQR 0.0003 to 0.036). There was a linear association of log ICC with log prevalence in both datasets (GPRD, regression coefficient 0.61, 95% confidence interval 0.53 to 0.69, P < 0.001; HTA, 0.91, 0.81 to 1.01, P < 0.001). When the prevalence was 1% the predicted ICC was 0.008 from the GPRD or 0.002 from the HTA, but when the prevalence was 40% the predicted ICC was 0.075 (GPRD) or 0.046 (HTA). CONCLUSION: the prevalence of an outcome may be used to make an informed assumption about the magnitude of the intraclass correlation coefficient.

BACKGROUND: it has been proposed that greater availability of primary medical care practitioners (GPs) contributes to better population health. We evaluated whether measures of the supply and structure of primary medical services are associated with health and health care indicators after adjusting for confounding. METHODS: Data for the supply and structure of primary medical services and the characteristics of registered patients were analysed for 99 health authorities in England in 1999. Health and health care indicators as dependent variables included standardised mortality ratios (SMR), standardised hospital admission rates, and conceptions under the age of 18 years. Linear regression analyses were adjusted for Townsend score, proportion of ethnic minorities and proportion of social class IV/ V. RESULTS: Higher proportions of registered rural patients and patients. > /= 75 years were associated with lower Townsend deprivation scores, with larger partnership sizes and with better health outcomes. A unit increase in partnership size was associated with a 4.2 (95% confidence interval 1.7 to 6.7) unit decrease in SMR for all-cause mortality at 15-64 years (P = 0.001). A 10% increase in single-handed practices was associated with a 1.5 (0.2 to 2.9) unit increase in SMR (P = 0.027). After additional adjustment for percent of rural and elderly patients, partnership size and proportion of single-handed practices, GP supply was not associated with SMR (-2.8, -6.9 to 1.3, P = 0.183). CONCLUSIONS: After adjusting for confounding with health needs of populations, mortality is weakly associated with the degree of organisation of practices as represented by the partnership size but not with the supply of GPs.

BACKGROUND: it has been proposed that greater availability of primary medical care practitioners (GPs) contributes to better population health. We evaluated whether measures of the supply and structure of primary medical services are associated with health and health care indicators after adjusting for confounding. METHODS: Data for the supply and structure of primary medical services and the characteristics of registered patients were analysed for 99 health authorities in England in 1999. Health and health care indicators as dependent variables included standardised mortality ratios (SMR), standardised hospital admission rates, and conceptions under the age of 18 years. Linear regression analyses were adjusted for Townsend score, proportion of ethnic minorities and proportion of social class IV/ V. RESULTS: Higher proportions of registered rural patients and patients >/= 75 years were associated with lower Townsend deprivation scores, with larger partnership sizes and with better health outcomes. A unit increase in partnership size was associated with a 4.2 (95% confidence interval 1.7 to 6.7) unit decrease in SMR for all-cause mortality at 15-64 years (P = 0.001). A 10% increase in single-handed practices was associated with a 1.5 (0.2 to 2.9) unit increase in SMR (P = 0.027). After additional adjustment for percent of rural and elderly patients, partnership size and proportion of single-handed practices, GP supply was not associated with SMR (-2.8, -6.9 to 1.3, P = 0.183). CONCLUSIONS: After adjusting for confounding with health needs of populations, mortality is weakly associated with the degree of organisation of practices as represented by the partnership size but not with the supply of GPs.

BACKGROUND: it is known that mental illness is associated with increased suicide risk. It has been postulated that suicidality may be an independent clinical phenomenon and we investigate whether variability of mood may be a mediator of this. METHODS: Fifty-three psychiatric inpatients were assessed on the Montgomery-Asberg depression rating scale, once weekly, over a 4-week period. The SCID II was administered to diagnose co-morbid personality disorder. Hostility was measured with the Hostility and Direction of Hostility questionnaire. A Fluctuation Index score was calculated to measure variability of mood. RESULTS: Unadjusted analyses suggested that patients with a history of deliberate self-harm showed greater variability in mood as measured by the fluctuation index (mean difference=13.4; 95% CI=4.3 to 22.6; P=0.005) though this relationship was no longer significant at the 5% level after adjustment (mean difference=13.4; 95% CI=-2.0 to 28.8; P=0.09). LIMITATIONS: There was a high initial dropout rate from the study and a small sample size. A prospective study would have more power in determining the effect of mood fluctuations. CONCLUSIONS: Mood fluctuation may be a useful indicator of risk of deliberate self-harm and attempted suicide.

BACKGROUND: Evidence suggests that cluster randomized trials are often poorly designed and analysed. There is little recent research on the methodologic quality of cluster randomized trials and none focuses on primary health care where these trials are increasingly common. METHODS: We conducted a systematic review of recent cluster randomized trials in primary health care, searching the Cochrane Controlled Trials Register. We also searched for unpublished trials in conference proceedings, and the UK National Research Register. We assess methodologic quality using a checklist, articulate problems facing investigators conducting these trials, and examine the extent to which carrying out a cluster randomized trial (as opposed to an individually randomized trial) in primary care may reduce power. RESULTS: We found 367 trial reports. Many trials were reported more than once. We characterize 152 independent cluster randomized trials in primary health care published between 1997 and 2000, and briefly describe 47 trials unpublished at December 2000. The quality of design and analysis was variable. of published trials reporting sample size calculations 20% accounted for clustering in these calculations, 59% of published trials accounted for clustering in analyses. Unpublished trials were more recent and of higher quality. Reporting quality was better in journals reporting more cluster randomized trials. Many trial investigators reported problems with adherence to protocol, recruitment and type of intervention. CONCLUSIONS: Methodologic quality of cluster randomized trials in primary health care is variable and reporting needs improvement. The use of cluster randomization should be indicated in the title or abstract so these kinds of trials are easier to identify. Communicating appropriate methodology to health care researchers continues to be a challenge. Cluster randomized trials should always be piloted and information from pilots and unsuccessful trials shared more widely.

Objectives: to examine the relationship between life events and survival for people with dementia. To investigate whether this relationship differs from that for people without dementia. To identify which psychiatric and social factors are associated with survival in people with dementia. Method: a prospective cohort study with external controls. One hundred and sixteen people with dementia and 50 fit, elderly controls were assessed for life events over a 6-month period. They were followed-up at 5 years and data collected on length of survival. Results: There was an association between two or more severe life events and reduced survival. This association appeared stronger for controls than people with dementia although the interaction was not significant (p = 0.052). The only psychiatric or social factor associated with poor survival in dementia was depression. Other factors associated with reduced survival in the dementia group were male sex, older age, poor physical health, later age of onset and a poorer level of functioning. Conclusions: This study provides some evidence that having two or more stressful and negative life events may reduce survival in older people with and without dementia. If replicated this finding will have implications for our understanding of the clinical course of dementia.

OBJECTIVE: to provide information concerning the magnitude of the intraclass correlation coefficient (ICC) for cluster-based studies set in primary care. STUDY DESIGN AND SETTING: Reanalysis of data from 31 cluster-based studies in primary care to estimate intraclass correlation coefficients from random effects models using maximum likelihood estimation. RESULTS: ICCs were estimated for 1,039 variables. The median ICC was 0.010 (interquartile range [IQR] 0 to 0.032, range 0 to 0.840). After adjusting for individual- and cluster-level characteristics, the median ICC was 0.005 (IQR 0 to 0.021). A given measure showed widely varying ICC estimates in different datasets. In six datasets, the ICCs for SF-36 physical functioning scale ranged from 0.001 to 0.055 and for SF-36 general health from 0 to 0.072. In four datasets, the ICC for systolic blood pressure ranged from 0 to 0.052 and for diastolic blood pressure from 0 to 0.108. CONCLUSION: the precise magnitude of between-cluster variation for a given measure can rarely be estimated in advance. Studies should be designed with reference to the overall distribution of ICCs and with attention to features that increase efficiency.

The aim of this experimental study was to evaluate the effectiveness of three patient-focused interventions designed to increase patient question asking in clinical consultations. Patients were randomly allocated to one of five conditions to receive either one of three interventions or to serve as an attention control group or a control group. The primary outcome measure was question asking by the patient of their physician. Participants in the intervention groups did not ask more questions than participants in the control groups. Immediately after the consultation participants in the intervention groups had higher levels of self-efficacy in asking questions. Three months after the index visit patients in the intervention groups were significantly more likely to be satisfied to some degree than patients in the control group. There was no difference in diabetic control. These results suggest that simple brief patient-focused interventions do not change patient behaviour in medical outpatient consultations.

BACKGROUND: Deliberate self-harm can be costly, in terms of treatment and subsequent suicide. Any intervention that reduces episodes of self-harm might therefore have a major impact on the costs incurred by service providers and the productivity losses due to illness or premature death. METHOD: Four hundred and eighty patients with a history of recurrent deliberate self-harm were randomized to manual-assisted cognitive behaviour therapy (MACT) or treatment as usual. Economic data were collected from patients at baseline, 6 and 12 months, and these data were complete for 397 patients. Incremental cost-effectiveness was explored using the primary outcome measure, proportion of patients having a repeat episode of deliberate self-harm, and quality of life. The uncertainty surrounding costs and effects was represented using cost-effectiveness acceptability curves. RESULTS: Differences in total cost per patient were statistically significant at 6 months in favour of MACT (pounds sterling -897, 95 % CI -1747 to -48, P=0.04), but these differences did not remain significant at 12 months (pounds sterling -838, 95% CI -2142 to 466, P=0.21). Nevertheless, exploration of the uncertainty surrounding these estimates suggests there is >90% probability that MACT is a more cost-effective strategy for reducing the recurrence of deliberate self-harm in this population over 1 year than treatment as usual. The results for quality of life were not conclusive. CONCLUSION: Cost-effectiveness acceptability curves demonstrate that, based on the evidence currently available, to reject MACT on traditional grounds of statistical significance and to continue funding current practice has

OBJECTIVE: to identify factors which determine whether and when patients will disclose infection with genital herpes to sexual partners. METHODS: the sample was 26 women and 24 men attending a herpes clinic in a sexually transmitted disease clinic. Semistructured interviews yielded quantitative data and also qualitative data which were subjected to content analysis. RESULTS: Characteristics of partners were very important in determining whether disclosure occurred. Respondents were less likely to tell partners regarded as casual. Perception of the likely reaction of partners was important in deciding whether to tell. Many respondents assumed that they were not infectious if they were not currently having an attack or if they were taking antiviral medication. The decision whether to tell tended to be based on considerations of likely discovery and of honesty towards the partner rather than control of transmission. of patient characteristics only self rated depressed mood was related to disclosure to the most recent partner. CONCLUSIONS: Perception of the partner and anticipated partner response is crucially important in determining whether and when disclosure of genital herpes infection occurs.

The intraclass correlation coefficient rho plays a key role in the design of cluster randomized trials. Estimates of rho obtained from previous cluster trials and used to inform sample size calculation in planned trials may be imprecise due to the typically small numbers of clusters in such studies. It may be useful to quantify this imprecision. This study used simulation to compare different methods for assigning bootstrap confidence intervals to rho for continuous outcomes from a balanced design. Data were simulated for combinations of numbers of clusters (10, 30, 50), intraclass correlation coefficients (0.001, 0.01, 0.05, 0.3) and outcome distributions (normal, non-normal continuous). The basic, bootstrap-t, percentile, bias corrected and bias corrected accelerated bootstrap intervals were compared with new methods using the basic and bootstrap-t intervals applied to a variance stabilizing transformation of rho. The standard bootstrap methods provided coverage levels for 95 per cent intervals that were markedly lower than the nominal level for data sets with only 10 clusters, and only provided close to 95 per cent coverage when there were 50 clusters. Application of the bootstrap-t method to the variance stabilizing transformation of rho improved upon the performance of the standard bootstrap methods, providing close to nominal coverage.

BACKGROUND: We carried out a large randomized trial of a brief form of cognitive therapy, manual-assisted cognitive behaviour therapy (MACT) versus treatment as usual (TAU) for deliberate self-harm. METHOD: Patients presenting with recurrent deliberate self-harm in five centres were randomized to either MACT or (TAU) and followed up over 1 year. MACT patients received a booklet based on cognitive behaviour therapy (CBT) principles and were offered up to five plus two booster sessions of CBT from a therapist in the first 3 months of the study. Ratings of parasuicide risk, anxiety, depression, social functioning and global function, positive and negative thinking, and quality of life were measured at baseline and after 6 and 12 months. RESULTS: Four hundred and eighty patients were randomized. Sixty per cent of the MACT group had both the booklet and CBT sessions. There were seven suicides, five in the TAU group. The main outcome measure, the proportion of those repeating deliberate self-harm in the 12 months of the study, showed no significant difference between those treated with MACT (39%) and treatment as usual (46%) (OR 0.78, 95% CI 0.53 to 1.14, P=0.20). CONCLUSION: Brief cognitive behaviour therapy is of limited efficacy in reducing self-harm repetition, but the findings taken in conjunctin with the economic evaluation (Byford et al. 2003) indicate superiority of MACT over TAU in terms of cost and effectiveness combined.

The treatment protocol and baseline characteristics of 480 subjects with a history of repeated parasuicide recruited in five centres to a randomised therapeutic trial of manual assisted cognitive-behaviour therapy (MACT) and treatment as usual (TAU) are described. Most patients had significant anxiety and depressive disturbance with 42% having a personality disorder. Variation in service policies influenced recruitment, with earlier assessment centres seeing people with more frequent episodes of self-harm and greater parasuicide risk than later ones. Parasuicide risk was also significantly greater in those with their first parasuicide episode at an earlier age and in those with a more recent latest episode.

This study compared different methods for assigning confidence intervals to the analysis of variance estimator of the intraclass correlation coefficient (rho). The context of the comparison was the use of rho to estimate the variance inflation factor when planning cluster randomized trials. The methods were compared using Monte Carlo simulations of unbalanced clustered data and data from a cluster randomized trial of an intervention to improve the management of asthma in a general practice setting. The coverage and precision of the intervals were compared for data with different numbers of clusters, mean numbers of subjects per cluster and underlying values of rho. The performance of the methods was also compared for data with Normal and non-Normally distributed cluster specific effects. Results of the simulations showed that methods based upon the variance ratio statistic provided greater coverage levels than those based upon large sample approximations to the standard error of rho. Searle's method provided close to nominal coverage for data with Normally distributed random effects. Adjusted versions of Searle's method to allow for lack of balance in the data generally did not improve upon it either in terms of coverage or precision. Analyses of the trial data, however, showed that limits provided by Thomas and Hultquist's method may differ from those of the other variance ratio statistic methods when the arithmetic mean differs markedly from the harmonic mean cluster size. The simulation results demonstrated that marked non-Normality in the cluster level random effects compromised the performance of all methods. Confidence intervals for the methods were generally wide relative to the underlying size of rho suggesting that there may be great uncertainty associated with sample size calculations for cluster trials where large clusters are randomized. Data from cluster based studies with sample sizes much larger than those typical of cluster randomized trials are required to estimate rho with a reasonable degree of precision.

The correct application of the variance inflation factor approach for sample size calculations in trials that randomize intact clusters of individuals rests on knowledge of the variance of the outcome under simple random allocation of individuals and the intraclass correlation coefficient at the given level of clustering. Each quantity may be derived from the between-and within-cluster variance components, but often only the latter component is available to investigators. Substitution of the outcome variance by the within-cluster variance may result in an underestimation of the sample size required. The paper presents a modified variance inflation factor formula which is appropriate for use when the within-cluster variance component is known, or can be estimated, and an assumption is possible for the intraclass correlation coefficient.

BACKGROUND: Despite much interest in the development of liaison psychiatry in general practice there is no clear evidence that any form of intervention is effective. We carried out a pilot randomised controlled trial, the first we believe into this type of care, of one such model; enhanced liaison with individual patients by key workers, in general practices in Paddington and North Kensington in London. METHODS: all patients referred from primary to secondary psychiatric care from four general practices over a 10-month period, and still in contact with services, were eligible to be included in the study. The practices were allocated in a constrained randomised procedure to either normal care or enhanced key-worker liaison. The latter involved encouraging individual key workers to adopt improved communication between primary and secondary care. Baseline assessments of symptomatology and social functioning were made before randomisation and after 6 months by an independent researcher. RESULTS: of the 84 eligible patients, 43 were seen at baseline and 34 re-assessed after 6 months. There was no difference between the clinical outcomes in the two groups but self-rated social function was significantly improved in the enhanced liaison service compared with standard care (adjusted P = 0.05). Costs were similar but somewhat more expensive for enhanced liaison. Less than half (42 %) of all key workers in the enhanced liaison arm felt they had involved the primary health care team more in the care of their patient, with 21 % of these altering their practice markedly during the study. CONCLUSIONS: it is concluded that without additional resources enhanced key-worker liaison for psychiatry in primary and secondary care has limited benefits although this does not necessarily apply to other forms of liaison practice.

BACKGROUND: Recent research has shown that patients' expectations for prescriptions influence doctors' prescribing decisions, but little is known of the antecedents of these expectations. OBJECTIVES: to test earlier qualitative research about patients' views of medicines; to describe the demographic characteristics of those holding orthodox and unorthodox views of medicines; to investigate the relationship between patients' ideal and predicted expectations for prescriptions; and to determine the relative effects of attitudinal, demographic, organizational and illness variables on these expectations. DESIGN: Questionnaire survey of patients consulting general practitioners. SETTING AND PARTICIPANTS: a total of 544 patients and 15 doctors in four general practices. MAIN VARIABLES STUDIED: Patients' attitudes to medicines; patients' demographic characteristics; organizational variables; aspects of patients' presenting problems. OUTCOME MEASURES: Patients' ideal and predicted expectations for prescriptions. RESULTS: Orthodox and unorthodox attitudes to medicines can be measured quantitatively, and ethnicity was the only demographic variable associated with both. Ideal and predicted expectations for prescriptions were closely related to each other but differed in their antecedents. Both types of expectations were associated with attitudinal, demographic, organizational and illness variables. Ideal expectations were influenced by orthodox and unorthodox attitudes to medicines, while predicted expectations were only influenced by orthodox attitudes. CONCLUSIONS: Future studies of patients' expectations for health services should distinguish between ideal and predicted expectations, and should consider the range of possible influences on these expectations. In particular, the effect of the organization and context of health services should be investigated.

BACKGROUND: Much of the difficulty in helping the homeless mentally ill arises as a consequence of their resistance to engagement. A refused intervention can seldom influence a client's problems and engagement status can be argued as being an important independent predictor of outcome. No instrument could be identified which systematically measured the factors involved. This paper describes the development and psychometric properties of a new scale, the Homeless Engagement and Acceptance Scale (HEAS). METHOD: Staff from an established project for the homeless mentally ill helped to identify relevant questions used to develop a five-item rating scale for completion by an informant. After piloting, the instrument was tested in a study in which subjects were assessed twice over 12 months by informants. Item analysis was undertaken and predictive validity was assessed. RESULTS: Item analysis indicated a good facility index signifying all items were able to differentiate subjects according to the characteristic being measured, and a high discrimination index demonstrating that all items were measuring the same concept. Predictive validity and internal consistency coefficients were both good. The 3 month HEAS score was found to be a significant predictor of accommodation status and adequacy of a support network at 12 months. CONCLUSIONS: the good psychometric properties and predictive validity of the scale suggest the HEAS is likely to be a useful tool in assessing engagement status. One of the five questions (Q4) can be omitted for those who are not homeless and the scale termed the Engagement and Acceptance Scale (EAS).

Analytical techniques appropriate for cluster randomized trials that utilize a repeated cross-sectional design have not been extensively evaluated. This paper compares methods that can be used to evaluate the impact of an intervention on dichotomous outcomes. The methods are applied to data from a study on the implementation of Cochrane review evidence, in which 25 hospital obstetric units were randomized. Assessments were made for 30 pregnancies in each obstetric unit at baseline, and for 30 separate pregnancies at follow-up. The principal issues addressed are how best to take clustering into account and to allow for baseline imbalance. We compare cluster level analyses, the clustered Woolf method, marginal models based on generalized estimating equations, multilevel models, and methods based on random effects meta-analysis. Analyses which ignored the baseline assessments showed no effect of the intervention. There was substantial baseline imbalance, however, so that analyses taking into account the baseline were necessary. Yet, while analyses of change from baseline showed evidence of an effect of intervention, adjusting for baseline using analysis of covariance did not. Analysis of covariance required the use of cluster level rather than individual level responses, since different pregnancies were evaluated at baseline and follow-up. Also, when analysing change from baseline, we show it is important to allow for variation in the effect of secular trend between clusters in a multilevel model, or use robust variance estimates in a marginal model, for otherwise confidence intervals for the effect of intervention will be too narrow. We conclude however that analyses of change from baseline can be misleading since they are affected too much by baseline results, and that analysis of covariance approaches are preferable. To prevent difficulties in interpreting the results from repeated cross-sectional cluster trial designs, one should either attempt to achieve baseline balance by careful stratification of the clusters prior to randomization, or have sufficiently large samples for precise estimation of the effects of imbalance.

OBJECTIVE: We evaluated cigarette smoking, alcohol intake and consumption of different foods as determinants of glycated haemoglobin in a general population sample. DESIGN: Cross-sectional survey. SETTING: England. SUBJECTS: Representative sample of 15 809 adults aged 16 y and older. Data analysed for 9772 non-diabetic, white European subjects. MAIN OUTCOME MEASURES: Glycated haemoglobin (GHb). Analyses were adjusted for age, sex, body mass index (BMI), waist-hip circumference ratio, activity level, and educational attainment. RESULTS: After adjusting for confounding, GHb was 0.277% (95% confidence interval 0.218 to 0.336) higher in current smokers of 20 or more per day, compared with non-smokers. GHb was 0.189% (0.101 to 0.277) lower in those drinking 42 or more units of alcohol per week than in non-drinkers. GHb was not associated with frequency of consumption of pulses, fruit, vegetables and salads, cakes, bread or confectionery. GHb was higher in subjects who took sugar in tea (0.051%, 0.015 to 0.087%) or in coffee (0.069%, 0.034 to 0.105%). GHb was higher in subjects who used solid fat for cooking (0.082%, 0.022 to 0.142%), or who drank whole rather than reduced-fat milk (0.088%, 0.036 to 0.140%), or used butter or hard margarine rather than low-fat spreads (0.075%, 0.029 to 0.121%). CONCLUSIONS: in the general population, higher GHb may be associated with cigarette smoking, or frequent consumption of fat-containing foods. Consumption of alcohol may be associated with lower GHb. SPONSORSHIP: None.

We evaluated variations in medical care for diabetes among government health centres in Trinidad and Tobago. Data were analysed for 1579 subjects with clinical diabetes attending 23 health centres concerning 12 processes of care and six case-mix or outcome variables. Random effects models were used for analysis. Health centre level variation was appreciable. Intraclass correlations ranged from 0.025 to 0.316 for process of care variables and 0.000 to 0.056 for case-mix variables. Compared with health centres with only one nurse, patients attending those with three or more nurses received 1.18 (95% confidence interval 0.27 to 2.09) more processes of care. Delivery of medical care varied among the health centres and those with higher staffing levels provided more processes of care.

BACKGROUND: Little research has been carried out on the benefits of intensive case management (ICM) for people with borderline IQ and severe mental illness. AIMS: to compare outcome and costs of care of patients with severe psychotic illness with borderline IQ to patients of normal IQ and to assess whether ICM is more beneficial for the former than for the latter. METHOD: the study utilises data from the UK700 multi-centre randomised controlled trial of case management. The main outcome measure was the number of days spent in hospital for psychiatric reasons. Secondary outcomes were costs of care and clinical outcome. RESULTS: ICM was significantly more beneficial for borderline-IQ patients than those of normal IQ in terms of reductions in days spent in hospital, hospital admissions, total costs and needs and increased satisfaction. CONCLUSIONS: ICM appears to be a cost-effective strategy for a subgroup of patients with severe psychosis with cognitive deficits.

BACKGROUND: Studies of intensive case management (ICM) for patients with psychotic illnesses have produced conflicting results in terms of outcome. Negative results have sometimes been attributed to a failure to deliver differing patterns of care. AIMS: to test whether the actual care delivered in a randomised clinical trial of ICM v. standard case management (the UK700 trial) differed significantly. METHOD: Data on 545 patients' care were collected over 2 years. All patient contacts and all other patient-centred interventions (e.g. telephone calls, carer contacts) of over 15 minutes were prospectively recorded. Rates and distributions of these interventions were compared. RESULTS: Contact frequency was more than doubled in the ICM group. There were proportionately more failed contacts and carer contacts but there was no difference in the average length of individual contacts or the proportion of contacts in the patients' homes. CONCLUSIONS: the failure to demonstrate outcome differences in the UK700 study is not due to a failure to vary the treatment process. UK standard care contains many of the characteristics of assertive outreach services and differences in outcome may require that greater attention be paid to delivering evidence-based interventions.

One hundred fifty-five (77%) of 201 participants recruited in a trial of intensive vs standard case management of patients with recurrent psychotic illness had their personality status measured before treatment and were followed up for two years. The primary outcome was the total number of days spent in psychiatric hospitalisation in the two years following randomisation. Thirty-three (21%) of the patients had a personality disorder and their duration of hospital stay (105 days) was greater than in those without personality disorder (56 days). There was weak evidence that intensive case management more effective in reducing the duration of care in those with personality disorder than in those without personality disorder.

BACKGROUND: There is currently great concern over the demands on psychiatric services in metropolitan areas in most developed countries, and this is exemplified in capital cities. These greater demands were not anticipated by those planning psychiatric services and the consequences have led to insufficient beds in many areas. We investigated the geographical mobility (the number of changes of address in the past 2 years) of patients presenting to services in greater London, to determine whether this might be a possible factor in the increased demand. METHOD: the geographical mobility of the severely mentally ill was determined by taking a random sample of all psychiatric admissions to hospitals serving residents in the London area over the calendar year of 1994 (n = 156) and an equivalent sample of patients in an established community mental health team (n = 74) in one area (Paddington). The extent of geographical movement was determined for the 2 years prior to interview. RESULTS: Greater geographical movement in the in-patient group was found for those living in inner London compared with outer London and for patients admitted to hospitals outside their catchment area. Twenty-eight percent of the in-patient sample had changed address in the year before admission (including 13% more than once) and 39% had changed address in the 2 years prior to admission. By contrast, the patients seen by the community psychiatric team were less than half as likely to have changed address over the previous year as the in-patients, and none of the community team's patients had changed address more than once over the previous year. The geographically mobile patients had significantly longer periods in hospital than geographically stable patients. CONCLUSION: Geographical mobility of psychiatric patients in London is high and is particularly marked for those presenting for in-patient treatment. These findings suggest that greater mobility could be one of the most important reasons for the higher than expected demands on psychiatric services and the difficulties in maintaining contact with patients in London in general and inner London in particular. More attention should be paid to geographical mobility as a predictor of psychiatric service use, and it is recommended that it is recorded regularly in information systems.

The authors estimated components of variance and intraclass correlation coefficients (ICCs) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for England 1994. This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes. For the survey, households were sampled in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities. Study subjects were adults aged 16 years or more. ICCs and components of variance were estimated from a nested random-effects analysis of variance. Results are presented at the district health authority, postal code sector, and household levels. Between-cluster variation was evident at each level of clustering. In these data, ICCs were inversely related to cluster size, but design effects could be substantial when the cluster size was large. Most ICCs were below 0.01 at the district health authority level, and they were mostly below 0.05 at the postal code sector level. At the household level, many ICCs were in the range of 0.0-0.3. These data may provide useful information for the design of epidemiologic studies in which the units sampled or allocated range in size from households to large administrative areas.

OBJECTIVES: to measure patients' expectations of receiving prescriptions and general practitioners' perceptions of these expectations and to determine the factors most closely associated with the decision to prescribe. DESIGN: Questionnaires were completed by patients waiting to see their general practitioners, and by their doctors immediately after the consultations. SETTING: Four non-fundholding groups practices in southeast London. SUBJECTS: 544 unselected patients consulting 15 general practitioners. MAIN OUTCOME MEASURES: Doctor's perceptions of patients' expectations; doctors' decisions to prescribe. RESULTS: 67% (354/526) of patients hoped for a prescription; doctors perceived that 56% (305/542) of patients wanted prescriptions; and doctors wrote prescriptions in 59% (321/543) of consultations. Despite the close agreement between patients' hopes and doctors' perceptions, 25% (89/353) of patients hoped for a prescription but did not receive one. In 22% (68/313) of consultations in which prescriptions were written, they were not strictly indicated on purely medical grounds, and in only 66% (202/306) of consultations in which prescriptions were written were they both indicated and hoped for. Doctors' perceptions of patients' expectations were the strongest predictor of the decision to prescribe, but the final regression model also included patients' hopes and ethnic group, and the doctor's feeling of being pressurised. CONCLUSIONS: in an area of low prescribing and high expectations the decision to prescribe was closely related to actual and perceived expectations, but the latter was the more significant influence.