Data Resource Profile: Clinical Practice Research Datalink (CPRD).

The Clinical Practice Research Datalink (CPRD) is an ongoing primary care database of anonymised medical records from general practitioners, with coverage of over 11.3 million patients from 674 practices in the UK. With 4.4 million active (alive, currently registered) patients meeting quality criteria, approximately 6.9% of the UK population are included and patients are broadly representative of the UK general population in terms of age, sex and ethnicity. General practitioners are the gatekeepers of primary care and specialist referrals in the UK. The CPRD primary care database is therefore a rich source of health data for research, including data on demographics, symptoms, tests, diagnoses, therapies, health-related behaviours and referrals to secondary care. For over half of patients, linkage with datasets from secondary care, disease-specific cohorts and mortality records enhance the range of data available for research. The CPRD is very widely used internationally for epidemiological research and has been used to produce over 1000 research studies, published in peer-reviewed journals across a broad range of health outcomes. However, researchers must be aware of the complexity of routinely collected electronic health records, including ways to manage variable completeness, misclassification and development of disease definitions for research.LS is supported by a Wellcome Trust Senior Research Fellowship in Clinical Science grant number 098504/Z/12/Z

From Provider to Enabler of Care: Reconfiguring Local Authority Support for Older People and Carers in Leeds, 2008 to 2013

This article explores developments in the support available to older people and carers (i.e., caregivers) in the city of Leeds, United Kingdom, and examines provision changes during a period characterized by unprecedented resource constraint and new developments in national-local governance. Using documentary evidence, official statistics and findings from recent studies led by the author, the effects of these changes on service planning and delivery and the approach taken by local actors to mitigate their impact are highlighted. The statistical data show a marked decline in some types of services for older people during a five year period during which the city council took steps to mobilize citizens and develop new services and system improvements. The analysis focuses on theories of social quality as a framework for analysis of the complex picture of change related to service provision. It concludes that although citizen involvement and consultations exerted a positive influence in delivering support to some older people and carers, research over a longer timescale is needed to show if these changes are adequate to protect older people and carers from the effects of ongoing budgetary constraints

Randomised controlled trial evaluating the effectiveness and cost-effectiveness of 'Families for Health', a family-based childhood obesity treatment intervention delivered in a community setting for ages 6 to 11 years

Background: Effective programmes to help children manage their weight are required. ‘Families for Health’ focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health version 1 showed sustained reductions in mean body mass index (BMI) z-score after 2 years in a pilot project. Objective: The aim was to evaluate its effectiveness and cost-effectiveness in a randomised controlled trial (RCT). Design: The trial was a multicentre, investigator-blind RCT, with a parallel economic and process evaluation, with follow-up at 3 and 12 months. Randomisation was by family unit, using a 1 : 1 allocation by telephone registration, stratified by three sites, with a target of 120 families. Setting: Three sites in the West Midlands, England, UK. Participants: Children aged 6–11 years who were overweight (≥ 91st centile BMI) or obese (≥ 98th centile BMI), and their parents/carers. Recruitment was via referral or self-referral. Interventions: Families for Health version 2 is a 10-week, family-based community programme with parallel groups for parents and children, addressing parenting, lifestyle, social and emotional development. Usual care was the treatment for childhood obesity provided within each locality. Main outcome measures: Joint primary outcome measures were change in children’s BMI z-score and incremental cost per quality-adjusted life-year (QALY) gained at 12 months’ follow-up (QALYs were calculated using the European Quality of Life-5 Dimensions Youth version). Secondary outcome measures included changes in children’s waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. Parents’ BMI and mental well-being, family eating/activity, parent–child relationships and parenting style were also assessed. The process evaluation documented recruitment, reach, dose delivered, dose received and fidelity, using mixed methods. Results: The study recruited 115 families (128 children; 63 boys and 65 girls), with 56 families randomised to the Families for Health arm and 59 to the ‘usual-care’ control arm. There was 80% retention of families at 3 months (Families for Health, 46 families; usual care, 46 families) and 72% retention at 12 months (Families for Health, 44 families; usual care, 39 families). The change in BMI z-score at 12 months was not significantly different in the Families for Health arm and the usual-care arm [0.114, 95% confidence interval (CI) –0.001 to 0.229; p = 0.053]. However, within-group analysis showed that the BMI z-score was significantly reduced in the usual-care arm (–0.118, 95% CI –0.203 to –0.034; p = 0.007), but not in the Families for Health arm (–0.005, 95% CI –0.085 to 0.078; p = 0.907). There was only one significant difference between groups for secondary outcomes. The economic evaluation, taking a NHS and Personal Social Services perspective, showed that mean costs 12 months post randomisation were significantly higher for Families for Health than for usual care (£998 vs. £548; p < 0.001). The mean incremental cost-effectiveness of Families for Health was estimated at £552,175 per QALY gained. The probability that the Families for Health programme is cost-effective did not exceed 40% across a range of thresholds. The process evaluation demonstrated that the programme was implemented, as planned, to the intended population and any adjustments did not deviate widely from the handbook. Many families waited more than 3 months to receive the intervention. Facilitators’, parents’ and children’s experiences of Families for Health were largely positive and there were no adverse events. Further analysis could explore why some children show a clinically significant benefit while others have a worse outcome. Conclusions: Families for Health was neither effective nor cost-effective for the management of obesity in children aged 6–11 years, in comparison with usual care. Further exploration of the wide range of responses in BMI z-score in children following the Families for Health and usual-care interventions is warranted, focusing on children who had a clinically significant benefit and those who showed a worse outcome with treatment. Further research could focus on the role of parents in the prevention of obesity, rather than treatment. Trial registration: Current Controlled Trials ISRCTN45032201. 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. 21, No. 1. See the NIHR Journals Library website for further project information

Clustering of behavioural risk factors for health in UK adults in 2016: a cross-sectional survey (Forthcoming/Available Online)

Background Foods high in fat, sugar and salt (HFSS) are known to contribute to overweight and obesity. In addition to overweight and obesity, smoking, alcohol consumption and physical inactivity are known risk factors for non-communicable diseases, including several cancers and cardiovascular disease. Methods Secondary analysis of UK-representative cross-sectional survey data of 3293 adults aged 18+. Regression analyses were undertaken to understand the relationship between consumption of HFSS food and soft drinks, alcohol and tobacco and socio-demographics. Clustering analysis identified groupings of health risk factors. Results Males, those aged 18–24 and those from the more deprived groups consumed ready meals and fast food most frequently. Most of the sample (77.3%) engaged in at least one health risk behaviour. Six clusters were identified in the clustering analysis. Older (65+) female respondents were more likely to be inactive. Smokers exhibiting additional risk behaviours were more likely to be of working age from more deprived groups, and men over 65 were more likely to consume harmful levels of alcohol with additional risk factors. Conclusion Policies and services in the UK tend to focus on changing behaviour to address individual risk factors. This study shows that policies and interventions need to address multiple risk factors

The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6-7 years.

BACKGROUND: Systematic reviews suggest that school-based interventions can be effective in preventing childhood obesity, but better-designed trials are needed that consider costs, process, equity, potential harms and longer-term outcomes. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) study intervention, compared with usual practice, in preventing obesity among primary school children. DESIGN: A cluster randomised controlled trial, split across two groups, which were randomised using a blocked balancing algorithm. Schools/participants could not be blinded to trial arm. Measurement staff were blind to allocation arm as far as possible. SETTING: Primary schools, West Midlands, UK. PARTICIPANTS: Schools within a 35-mile radius of the study centre and all year 1 pupils (aged 5-6 years) were eligible. Schools with a higher proportion of pupils from minority ethnic populations were oversampled to enable subgroup analyses. INTERVENTIONS: The 12-month intervention encouraged healthy eating/physical activity (PA) by (1) helping teachers to provide 30 minutes of additional daily PA, (2) promoting 'Villa Vitality' (interactive healthy lifestyles learning, in an inspirational setting), (3) running school-based healthy cooking skills/education workshops for parents and children and (4) highlighting information to families with regard to local PA opportunities. MAIN OUTCOME MEASURES: The primary outcomes were the difference in body mass index z-scores (BMI-zs) between arms (adjusted for baseline body mass index) at 3 and 18 months post intervention (clinical outcome), and cost per quality-adjusted life-year (QALY) (cost-effectiveness outcome). The secondary outcomes were further anthropometric, dietary, PA and psychological measurements, and the difference in BMI-z between arms at 27 months post intervention in a subset of schools. RESULTS: Two groups of schools were randomised: 27 in 2011 (n = 650 pupils) [group 1 (G1)] and another 27 in 2012 (n = 817 pupils) [group 2 (G2)]. Primary outcome data were available at first follow-up (n = 1249 pupils) and second follow-up (n = 1145 pupils) from 53 schools. The mean difference (MD) in BMI-z between the control and intervention arms was -0.075 [95% confidence interval (CI) -0.183 to 0.033] and -0.027 (95% CI -0.137 to 0.083) at 3 and 18 months post intervention, respectively. The main analyses showed no evidence of between-arm differences for any secondary outcomes. Third follow-up included data on 467 pupils from 27 G1 schools, and showed a statistically significant difference in BMI-z (MD -0.20, 95% CI -0.40 to -0.01). The mean cost of the intervention was £266.35 per consented child (£155.53 per child receiving the intervention). The incremental cost-effectiveness ratio associated with the base case was £46,083 per QALY (best case £26,804 per QALY), suggesting that the intervention was not cost-effective. LIMITATIONS: The presence of baseline primary outcome imbalance between the arms, and interschool variation in fidelity of intervention delivery. CONCLUSIONS: The primary analyses show no evidence of clinical effectiveness or cost-effectiveness of the WAVES study intervention. A post hoc analysis, driven by findings at third follow-up, suggests a possible intervention effect, which could have been attenuated by baseline imbalances. There was no evidence of an intervention effect on measures of diet or PA and no evidence of harm. FUTURE WORK: A realist evidence synthesis could provide insights into contextual factors and strategies for future interventions. School-based interventions need to be integrated within a wider societal framework and supported by upstream interventions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97000586. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 8. See the NIHR Journals Library website for further project information

Health Equity Indicators for the English NHS: a longitudinal whole-population study at the small-area level

Background: Inequalities in health-care access and outcomes raise concerns about quality of care and justice, and the NHS has a statutory duty to consider reducing them. Objectives: The objectives were to (1) develop indicators of socioeconomic inequality in health-care access and outcomes at different stages of the patient pathway; (2) develop methods for monitoring local NHS equity performance in tackling socioeconomic health-care inequalities; (3) track the evolution of socioeconomic health-care inequalities in the 2000s; and (4) develop ‘equity dashboards’ for communicating equity findings to decision-makers in a clear and concise format. Design: Longitudinal whole-population study at the small-area level. Setting: England from 2001/2 to 2011/12. Participants: A total of 32,482 small-area neighbourhoods (lower-layer super output areas) of approximately 1500 people. Main outcome measures: Slope index of inequality gaps between the most and least deprived neighbourhoods in England, adjusted for need or risk, for (1) patients per family doctor, (2) primary care quality, (3) inpatient hospital waiting time, (4) emergency hospitalisation for chronic ambulatory care-sensitive conditions, (5) repeat emergency hospitalisation in the same year, (6) dying in hospital, (7) mortality amenable to health care and (8) overall mortality. Data sources: Practice-level workforce data from the general practice census (indicator 1), practice-level Quality and Outcomes Framework data (indicator 2), inpatient hospital data from Hospital Episode Statistics (indicators 3–6) and mortality data from the Office for National Statistics (indicators 6–8). Results: Between 2004/5 and 2011/12, more deprived neighbourhoods gained larger absolute improvements on all indicators except waiting time, repeat hospitalisation and dying in hospital. In 2011/12, there was little measurable inequality in primary care supply and quality, but inequality was associated with 171,119 preventable hospitalisations and 41,123 deaths amenable to health care. In 2011/12, > 20% of Clinical Commissioning Groups performed statistically significantly better or worse than the England equity benchmark. Limitations: General practitioner supply is a limited measure of primary care access, need in deprived neighbourhoods may be underestimated because of a lack of data on multimorbidity, and the quality and outcomes indicators capture only one aspect of primary care quality. Health-care outcomes are adjusted for age and sex but not for other risk factors that contribute to unequal health-care outcomes and may be outside the control of the NHS, so they overestimate the extent of inequality for which the NHS can reasonably be held responsible. Conclusions: NHS actions can have a measurable impact on socioeconomic inequality in both health-care access and outcomes. Reducing inequality in health-care outcomes is more challenging than reducing inequality of access to health care. Local health-care equity monitoring against a national benchmark can be performed using any administrative geography comprising ≥ 100,000 people

The natural history of <i>Chlamydia trachomatis </i>infection in women:a multi-parameter evidence synthesis

Background and objectives: The evidence base supporting the National Chlamydia Screening Programme, initiated in 2003, has been questioned repeatedly, with little consensus on modelling assumptions, parameter values or evidence sources to be used in cost-effectiveness analyses. The purpose of this project was to assemble all available evidence on the prevalence and incidence of Chlamydia trachomatis (CT) in the UK and its sequelae, pelvic inflammatory disease (PID), ectopic pregnancy (EP) and tubal factor infertility (TFI) to review the evidence base in its entirety, assess its consistency and, if possible, arrive at a coherent set of estimates consistent with all the evidence. Methods: Evidence was identified using ‘high-yield’ strategies. Bayesian Multi-Parameter Evidence Synthesis models were constructed for separate subparts of the clinical and population epidemiology of CT. Where possible, different types of data sources were statistically combined to derive coherent estimates. Where evidence was inconsistent, evidence sources were re-interpreted and new estimates derived on a post-hoc basis. Results: An internally coherent set of estimates was generated, consistent with a multifaceted evidence base, fertility surveys and routine UK statistics on PID and EP. Among the key findings were that the risk of PID (symptomatic or asymptomatic) following an untreated CT infection is 17.1% [95% credible interval (CrI) 6% to 29%] and the risk of salpingitis is 7.3% (95% CrI 2.2% to 14.0%). In women aged 16–24 years, screened at annual intervals, at best, 61% (95% CrI 55% to 67%) of CT-related PID and 22% (95% CrI 7% to 43%) of all PID could be directly prevented. For women aged 16–44 years, the proportions of PID, EP and TFI that are attributable to CT are estimated to be 20% (95% CrI 6% to 38%), 4.9% (95% CrI 1.2% to 12%) and 29% (95% CrI 9% to 56%), respectively. The prevalence of TFI in the UK in women at the end of their reproductive lives is 1.1%: this is consistent with all PID carrying a relatively high risk of reproductive damage, whether diagnosed or not. Every 1000 CT infections in women aged 16–44 years, on average, gives rise to approximately 171 episodes of PID and 73 of salpingitis, 2.0 EPs and 5.1 women with TFI at age 44 years. Conclusions and research recommendations: The study establishes a set of interpretations of the major studies and study designs, under which a coherent set of estimates can be generated. CT is a significant cause of PID and TFI. CT screening is of benefit to the individual, but detection and treatment of incident infection may be more beneficial. Women with lower abdominal pain need better advice on when to seek early medical attention to avoid risk of reproductive damage. The study provides new insights into the reproductive risks of PID and the role of CT. Further research is required on the proportions of PID, EP and TFI attributable to CT to confirm predictions made in this report, and to improve the precision of key estimates. The cost-effectiveness of screening should be re-evaluated using the findings of this report. Funding: The Medical Research Council grant G0801947

The importance of over-the-counter-sales and product format in the environmental exposure assessment of active pharmaceutical ingredients

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