Multiple sclerosis health-related quality of life utility values from the UK MS register.

Background: New interventions for multiple sclerosis (MS) commonly require a demonstration of cost-effectiveness using health-related quality of life (HRQoL) utility values. The EQ-5D is the utility measure approved for use in the UK NHS funding decision-making. There are also MS-specific utility measures - e.g., MS Impact Scale Eight Dimensions (MSIS-8D) and MSIS-8D-Patient (MSIS-8D-P). Objectives: Provide EQ-5D, MSIS-8D and MSIS-8D-P utility values from a large UK MS cohort and investigate their association with demographic/clinical characteristics. Methods: UK MS Register data from 14,385 respondents (2011 to 2019) were analysed descriptively and using multivariable linear regression, with self-report Expanded Disability Status Scale (EDSS) scores. Results: The EQ-5D and MSIS-8D were both sensitive to differences in demographic/clinical characteristics. An inconsistency found in previous studies whereby mean EQ-5D values were higher for an EDSS score of 4 rather than 3 was not observed. Similar utility values were observed between MS types at each EDSS score. Regression showed EDSS score and age were associated with utility values from all three measures. Conclusions: This study provides generic and MS-specific utility values for a large UK MS sample, with the potential for use in cost-effectiveness analyses of treatments for MS.

Rumination moderates the longitudinal associations of awareness of age-related change with depressive and anxiety symptoms.

OBJECTIVE: Lower awareness of age-related gains (AARC-gains) and higher awareness of age-related losses (AARC-losses) may be risk factors for depressive and anxiety symptoms. We explored whether: (1) Baseline AARC-gains and AARC-losses predict depressive and anxiety symptoms at one-year follow-up; (2) age and rumination moderate these associations; (3) levels of AARC-gains and AARC-losses differ among individuals with different combinations of current and past depression and/or with different combinations of current and past anxiety. METHODS: In this one-year longitudinal cohort study participants (N = 3386; mean age = 66.0; SD = 6.93) completed measures of AARC-gains, AARC-losses, rumination, depression, anxiety, and lifetime diagnosis of depression and anxiety in 2019 and 2020. Regression models with tests of interaction were used. RESULTS: Higher AARC-losses, but not lower AARC-gains, predicted more depressive and anxiety symptoms. Age did not moderate these associations. Associations of lower AARC-gains and higher AARC-losses with more depressive symptoms and of higher AARC-losses with more anxiety symptoms were stronger in those with higher rumination. Individuals with both current and past depression reported highest AARC-losses and lowest AARC-gains. Those with current, but not past anxiety, reported highest AARC-losses. CONCLUSION: Perceiving many age-related losses may place individuals at risk of depressive and anxiety symptoms, especially those who frequently ruminate.

The longitudinal relationship between child emotional disorder and parental mental health in the British Child and Adolescent Mental Health surveys 1999 and 2004.

BACKGROUND: Research suggests parental psychopathology has an adverse effect on child mental health. However, due to the interactional nature of parent-child relationships and with a high rate of emotional disorders reported in school-age children, it is important to know whether the effect is reciprocal. METHODS: We explored the longitudinal relationship between child and parent mental health in the British Child and Adolescent Mental Health Surveys (N=7,100 child-parent dyads) and their three-year follow-ups. The Development and Well-Being Assessment with DSM-IV diagnostic criteria was used to measure child psychiatric diagnoses, while parental mental health was assessed using the General Health Questionnaire. Multivariable logistic regression was used to explore the longitudinal association between child emotional disorder and parent mental health. RESULTS: Parents of children who had an emotional disorder at baseline were more likely to have poor mental health three years later compared with parents whose children had no psychiatric diagnosis (33.3% versus 16.7%; crude odds ratio=2.52; adjusted odds ratio=2.19, 95% CI=1.58 to 3.05, p<0.001). Children of parents with poor mental health at baseline were more likely to develop an emotional disorder three years later compared with children whose parents had good mental health (5.2% versus 2.5%; crude odds ratio=2.08; adjusted odds ratio=1.63, 95% CI=1.18 to 2.25, p=0.003). LIMITATIONS: The findings of this research are limited by the survey data collected, the measures used and survey dropout. CONCLUSIONS: We detected a bi-directional relationship between child and parent mental health, suggesting that effective intervention for one individual may benefit other family members.

Psychological distress among primary school teachers: a comparison with clinical and population samples.

OBJECTIVES: This analysis explored the level of psychological distress among primary school teachers in the South West of England as compared with clinical and general population samples. STUDY DESIGN: Secondary analysis of data from the Supporting Teachers and Children in Schools (STARS) trial completed by up to 90 teachers at baseline, 9, 18 and 30 months of follow-up. METHODS: We used the Everyday Feelings Questionnaire (EFQ) as a measure of psychological distress. Baseline data on teachers were compared with a population sample of professionals and a clinical sample of patients attending a depression clinic. RESULTS: Our teacher cohort experienced higher levels of psychological distress than comparable professionals from the general population, which were sustained over 30 months of follow-up. Levels of psychological distress were lower than those found in the clinical sample. Using a cut-point indicative of moderate depression, our data suggest that between 19% and 29% of teachers experienced clinically significant distress at each time-point. CONCLUSIONS: We detected high and sustained levels of psychological distress among primary school teachers, which suggests an urgent need for intervention. Effective support for teachers' mental health is particularly important given the potential impact of poor teacher mental health on pupil well-being, pupil attainment and teacher-pupil relationships.

Examining the psychological and social impact of relative age in primary school children: a cross-sectional survey.

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.

Impact of a Brief Group Intervention to Enhance Parenting and the Home Learning Environment for Children Aged 6-36 Months: a Cluster Randomised Controlled Trial.

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 .

A study investigating short- and medium-term effects on function, bone mineral density and lean tissue mass post-total knee replacement in a Caucasian female post-menopausal population: implications for hip fracture risk.

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.

Diagnostic accuracy of high-definition CT coronary angiography in high-risk patients.

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.

Who gets help for pre-school communication problems? Data from a prospective community study.

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.

Comparison of cancer diagnostic intervals before and after implementation of NICE guidelines: analysis of data from the UK General Practice Research Database.

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<0.001) between 2001-2002 and 2007-2008. There was evidence of significant reductions for the following cancers: (mean, 95% confidence interval) kidney (20.4 days, -0.5 to 41.5; P=0.05), head and neck (21.2 days, 0.2-41.6; P=0.04), bladder (16.4 days, 6.6-26.5; P≤0.001), colorectal (9.0 days, 3.2-14.8; P=0.002), oesophageal (13.1 days, 3.0-24.1; P=0.006) and pancreatic (12.6 days, 0.2-24.6; P=0.04). Patients who presented with NICE-qualifying symptoms had shorter diagnostic intervals than those who did not (all cancers in both cohorts). For the 2007-2008 cohort, the cancers with the shortest median diagnostic intervals were breast (26 days) and testicular (44 days); the highest were myeloma (156 days) and lung (112 days). The values for the 90th centiles of the distributions remain very high for some cancers. Tests of interaction provided little evidence of differences in change in mean diagnostic intervals between those who did and did not present with symptoms specifically cited in the NICE Guideline as requiring urgent referral. CONCLUSION: We suggest that the implementation of the 2005 NICE Guidelines may have contributed to this reduction in diagnostic intervals between 2001-2002 and 2007-2008. There remains considerable scope to achieve more timely cancer diagnosis, with the ultimate aim of improving cancer outcomes.

A cluster randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of classroom-based cognitive-behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents.

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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN19083628. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 47. See the HTA programme website for further project information.

Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia: systematic reviews and economic analyses.

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' follow-up (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 cost-effectiveness 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 second-line 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 cost-effectiveness 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.

Profiles of language development in pre-school children: a longitudinal latent class analysis of data from the Early Language in Victoria Study.

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.

Association of change in daily step count over five years with insulin sensitivity and adiposity: population based cohort study.

OBJECTIVES: 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. DESIGN: Population based cohort study. SETTING: Tasmania, Australia. PARTICIPANTS: 592 adults (men (n=267), mean age 51.4 (SD 12.2) years; women (n=325), mean age 50.3 (12.3) years) who participated in the Tasmanian component of the national AusDiab Study in 2000 and 2005. MAIN OUTCOME MEASURES: Body mass index, waist to hip ratio, and HOMA insulin sensitivity at follow-up in 2005. RESULTS: Over the five year period, the daily step count decreased for 65% (n=382) of participants. Having a higher daily step count in 2005 than in 2000 was independently associated with lower body mass index (0.08 (95% confidence interval 0.04 to 0.12) lower per 1000 steps), lower waist to hip ratio (0.15 (0.07 to 0.23) lower), and greater insulin sensitivity (1.38 (0.14 to 2.63) HOMA units higher) in 2005. The mean increase in HOMA units fell to 0.34 (-0.79 to 1.47) after adjustment for body mass index in 2005. CONCLUSIONS: Among community dwelling, middle aged adults, a higher daily step count at five year follow-up than at baseline was associated with better insulin sensitivity. This effect seems to be largely mediated through lower adiposity.

Predictors of parents seeking help or advice about children's communication development in the early years.

BACKGROUND: Children's access to services for communication disorders is often determined by parental decisions to seek help or advice. The factors that predict whether parents seek help/advice about their child's communication development were explored in this study. METHODS: Parents of children in a large, community cohort of children (the Early Language in Victoria Study) were asked whether they had sought help or advice about speech and language development at 1, 2, 3 and 4 years. Child, family and environmental variables, as well as parental concern and children's communication status, were used to predict help/advice seeking. The communication abilities of those in the help-seeking group were also evaluated. RESULTS: Gender, age, children's communication status and parental concern were consistent predictors of help/advice seeking. Significant over and under-identification was evident, and there was preliminary evidence that children with overt communication difficulties (such as unintelligible speech) were more likely to receive help. CONCLUSIONS: Parental support and education, as well as education of professionals who regularly have contact with young children, is necessary to support appropriate early identification of communication problems. Further research into service level factors such as availability and accessibility which may support or inhibit help/advice seeking is also indicated.

The Early Language in Victoria Study: predicting vocabulary at age one and two years from gesture and object use.

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.

Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial [ISRCTN22532458].

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.

Brief smoking cessation advice from practice nurses during routine cervical smear tests appointments: a cluster randomised controlled trial assessing feasibility, acceptability and potential effectiveness.

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<0.001) longer than the control arm. In conclusion, brief smoking cessation advice given by practice nurses as part of cervical screening seems acceptable, feasible and potentially effective. Evidence is lacking on the effectiveness and cost effectiveness of this intervention in achieving biochemically validated smoking cessation.

Prevention of mental health problems: rationale for a universal approach.

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.

Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity.

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 <3.0) children aged 5 years 0 months-9 years 11 months (82 intervention, 81 control). INTERVENTION: Four standard GP consultations over 12 weeks, targeting change in nutrition, physical activity and sedentary behaviour, supported by purpose-designed family materials. MAIN OUTCOME MEASURES: Primary: BMI at 9 and 15 months post-randomization. Secondary: Parent-reported child nutrition, physical activity and health status; child-reported health status, body satisfaction and appearance/self-worth. RESULTS: Attrition was 10%. The adjusted mean difference (intervention-control) in BMI was -0.2 kg/m(2) (95% CI: -0.6 to 0.1; P=0.25) at 9 months and -0.0 kg/m(2) (95% CI: -0.5 to 0.5; P=1.00) at 15 months. There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months. There was weak evidence of an increase in daily physical activity in the intervention arm. Health status and body image were similar in the trial arms. CONCLUSIONS: This intervention did not result in a sustained BMI reduction, despite the improvement in parent-reported nutrition. Brief individualized solution-focused approaches may not be an effective approach to childhood overweight. Alternatively, this intervention may not have been intensive enough or the GP training may have been insufficient; however, increasing either would have significant cost and resource implications at a population level.