Katrina Hargreaves

Informed choice and public health screening for children: the case of blood spot screening

Objective  To examine parents’ and health professionals’ views on informed choice in newborn blood spot screening, and assess information and communication needs.

The social context of change in tobacco consumption following the introduction of ‘smokefree’ England legislation: A qualitative, longitudinal study

Legislation implemented in England on 1st July 2007 to prohibit smoking in enclosed public places aimed primarily to limit exposure to second-hand smoke, thereby reducing smoking-related morbidity and mortality. We conducted a qualitative study between April 2007 and December 2008 in six contrasting localities in two metropolitan areas in the north and south of England, which examined the impact of the legislation on individuals, families and communities. Using a multi-level longitudinal case study design, we collected data at community and individual levels, from three months prior to the legislation to a year after its enactment through a range of methods, including semi-structured interviews with panel informants and observations in locality settings. Drawing on theoretical understandings of the relationship between structure, agency and practice, this paper examines the social and cultural contexts of change in tobacco consumption. Observations in a variety of community settings identified reduced smoking in public places post-legislation. More than half of panel informants reported decreased consumption at one year post-legislation; a minority had quit, maintained or increased their smoking levels. The dominant pattern of reduced consumption was attributed primarily to constraints imposed by the legislation. This suggests that the law may have provided an impetus for some smokers to cut down or quit. Smoking behaviour was, however, strongly influenced by the social networks in which smokers were embedded, indicating that, while individuals had the power to act, any changes they made were largely shaped by social structural factors. Our findings support the need for a comprehensive tobacco control strategy that takes account of the complex array of contextual factors that constrain and enable smoking.

Newborn screening information supports public health more than informed choice

Objective To appraise information resources on newborn blood spot screening currently available for parents and health professionals internationally. Method Health information on newborn blood spot screening was sourced internationally through the internet and, in the United Kingdom, through health service providers and support organisations. An appraisal tool was developed based on DISCERN criteria for evaluating information about patient treatment choices and UK National Screening Committee criteria for determining whether a screening programme should be implemented. Two researchers independently applied the appraisal tool to all the leaflets describing the heel prick, then discussed and resolved discrepancies. Results The majority of leaflets supported the public health agenda by informing parents of the benefits of screening, including the significance of early detection and treatment for these conditions. Few leaflets, however, supported the informed choice agenda by mentioning either the limitations of screening, or choice, or by being easy to read. Conclusion Most health information about newborn blood spot screening portrays it in a positive light, and relatively few leaflets address the difficulties openly. We recommend the use of criteria for high-quality patient information alongside topic or condition-specific guidelines as a starting point for developing patient information.

Structured, intensive education maximising engagement, motivation and long-term change for children and young people with diabetes: a cluster randomised controlled trial with integral process and economic evaluation - the CASCADE study.

BACKGROUND Type 1 diabetes (T1D) in children and young people is increasing worldwide with a particular increase in children under the age of 5 years. Fewer than one in six children and young people achieve glycosylated fraction of haemoglobin (HbA1c) values in the range identified as providing best future outcomes. There is an urgent need for clinic-based pragmatic, feasible and effective interventions that improve both glycaemic control and quality of life (QoL). The intervention offers both structured education, to ensure young people know what they need to know, and a delivery model designed to motivate self-management. OBJECTIVE To assess the feasibility of providing a clinic-based structured educational group programme incorporating psychological approaches to improve long-term glycaemic control, QoL and psychosocial functioning in a diverse range of young people. DESIGN The study was a pragmatic, cluster randomised control trial with integral process and economic evaluation. SETTING Twenty-eight paediatric diabetes services across London, south-east England and the Midlands. RANDOMISATION Minimised by clinic size, age (paediatric or adolescent) and specialisation (district general hospital clinic or teaching hospital/tertiary clinic). ALLOCATION Half of the sites were randomised to the intervention arm and half to the control arm. Allocation was concealed until after clinics had consented and the first participant was recruited. Where possible, families were blind to allocation until recruitment finished. PARTICIPANTS Forty-three health-care practitioners (14 teams) were trained in the intervention. The study recruited 362 children aged 8-16 years, diagnosed with T1D for > 12 months, with a mean 12-month HbA1c level of ≥ 8.5%. INTERVENTION Two 1-day workshops taught intervention delivery. A detailed manual and resources were provided. The intervention consists of four group education sessions led by a paediatric diabetes specialist nurse with another team member. OUTCOMES The primary outcome was glycaemic control, assessed at the individual level using venous HbA1c values, measured at baseline, 12 and 24 months. Secondary outcomes were directly and indirectly related to diabetes management, including hypoglycaemic episodes, hospital admissions, diabetes regimen, knowledge, skills and responsibility for diabetes management, intervention compliance, clinic utilisation, emotional and behavioural adjustment, and general and diabetes-specific QoL. PROCESS EVALUATION Questionnaires, semistructured interviews, informal discussion following observation sessions, fieldwork notes and case note review were used to collect qualitative and quantitative data from key stakeholder groups at specific time points in the trial. STATISTICAL ANALYSES Primary and secondary analyses were intention-to-treat comparisons of outcomes at 12 and 24 months, using analysis of covariance with a random effect for clinic. Prespecified subgroup analyses based on age, gender, initial HbA1c value and socioeconomic status were estimated from models that included an interaction term. The economic analysis compared long-term costs and predicted quality-adjusted life-years (QALYs). RESULTS The intervention did not improve HbA1c at 12 months [intervention effect 0.11; 95% confidence interval (CI) -0.28 to 0.50; p = 0.584] or 24 months (intervention effect 0.03; 95% CI -0.36 to 0.41; p = 0.891). A total of 298/362 patients (82.3%) provided blood samples at 12-month follow-up, and 284/362 (78.5%) provided blood samples at 24-month follow-up. Follow-up questionnaires were completed by 307 patients (85.3%) at 12 months and by 295 patients (81.5%) at 24 months. Intervention group parents at 12 months (95% CI 0.74; 0.03 to 1.52) and young people at 24 months (0.85; 95% CI 0.03 to 1.61) had higher scores on the diabetes family responsibility questionnaire. Young people reported reduced happiness with body weight at 12 months (-0.56; 95% CI -1.03 to -0.06). Only 68% of groups were run. Of the 180 families recruited, 96 (53%) attended at least one module. Reasons for low uptake included difficulties organising groups, and work and school commitments. Young people with higher HbA1c levels were less likely to attend. Parents and young people who attended groups described improved family relationships, improved knowledge and understanding, greater confidence and increased motivation to manage diabetes. Twenty-four months after the intervention, nearly half of the young people reported that the groups had made them want to try harder and that they had carried on trying. A high-quality, complex, pragmatic trial of structured education can be delivered alongside standard care in NHS diabetes clinics. Health-care providers benefited from behaviour change skill training and can deliver pragmatic aspects of a National Institute for Health and Care Excellence (NICE)-compliant structured education programme after relatively brief training. The process evaluation provides insight into aspects of the model, and highlights strengths and aspects that may have contributed to the failure to influence primary and secondary outcomes. Current NHS practice dominates CASCADE (Child and Adolescent Structured Competencies Approach to Diabetes Education) in that it achieves the same number of QALYs at a lower cost. The mean cost of providing the intervention was £5098 per site or £683 per child. Members of paediatric diabetes services trained to deliver the CASCADE structured education package using behaviour change techniques did not improve glycaemic control in patients compared with control subjects 1 and 2 years after the intervention. The training workshops for practitioners were well evaluated; however, more intensive training was needed. The intervention cost £683 per patient but was not cost-effective because it did not improve metabolic control. CONCLUSIONS A high-quality, complex, pragmatic trial of structured education can be successfully conducted alongside standard care in NHS diabetes clinics. Pragmatic components of a NICE-compliant structured education programme can be successfully delivered following a relatively brief 2-day training while paediatric health-care professionals benefit from training in behaviour change skills. The study provides invaluable information on barriers and opportunities regarding future, similar interventions. A low dropout rate and good attendance for the subgroup that attended the intervention suggests there might be improved uptake if offered to young people with lower HbA1c. Testing whether this approach can be more successful with a robust ongoing supervisory element should be a target of further research. TRIAL REGISTRATION Current Controlled Trials ISRCTN52537669. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 20. See the NIHR Journals Library website for further project information.

The re-shaping of the life-world: male British Bangladeshi smokers and the English smoke-free legislation

Objective. To explore how male Bangladeshi smokers adapted to the English smoke-free legislation. Design. We draw on data derived from the Evaluation of Smoke-free England (ESME), a qualitative, longitudinal study conducted between 2007 and 2008 in two English metropolitan areas. Repeat interviews (n=34) were conducted before and after the legislation with 15 male Bangladeshi panel informants and from two focus groups: one with Bangladeshi men and the other with Bangladeshi women. Results. Bangladeshi smokers who participated in this study had largely accommodated to the smoke-free legislation and most had reduced their consumption of cigarettes, albeit to a modest degree. However, at the same time some Bangladeshi smokers appeared to have increased their use of shisha, a popular alternative method of smoking tobacco in this community. Smoke-free legislation also had an impact on the social and cultural forces that shape smoking behaviour in this group. In particular, family homes continued to be a key space where tobacco is consumed, although the legislation may have helped to shift the balance in favour of forces that oppose smoking and against enduring cultural pro-smoking norms. Smoking in public was also less socially acceptable, especially in the vicinity of local mosques and at community events. In some older groups, however, smoking remains a deeply embedded social habit which can undermine smokers’ efforts to quit. Conclusion. For maximum impact, tobacco control interventions aimed at whole populations may need to be supplemented by culturally sensitive measures in local areas where there is a high concentration of Bangladeshi people. Similar considerations may apply to other minority communities with a high prevalence of smoking.

Implementing a structured education program for children with diabetes: lessons learnt from an integrated process evaluation.

Background There is recognition of an urgent need for clinic-based interventions for young people with type 1 diabetes mellitus that improve glycemic control and quality of life. The Child and Adolescent Structured Competencies Approach to Diabetes Education (CASCADE) is a structured educational group program, using psychological techniques, delivered primarily by diabetes nurses. Composed of four modules, it is designed for children with poor diabetic control and their parents. A mixed methods process evaluation, embedded within a cluster randomized control trial, aimed to assess the feasibility, acceptability, fidelity, and perceived impact of CASCADE. Methods 28 pediatric diabetes clinics across England participated and 362 children aged 8–16 years, with type 1 diabetes and a mean glycosylated hemoglobin (HbA1c) of 8.5 or above, took part. The process evaluation used a wide range of research methods. Results Of the 180 families in the intervention group, only 55 (30%) received the full program with 53% attending at least one module. Only 68% of possible groups were run. Staff found organizing the groups burdensome in terms of arranging suitable dates/times and satisfactory group composition. Some staff also reported difficulties in mastering the psychological techniques. Uptake, by families, was influenced by the number of groups run and by school, work and other commitments. Attendees described improved: family relationships; knowledge and understanding; confidence; motivation to manage the disease. The results of the trial showed that the intervention did not significantly improve HbA1c at 12 or 24 months. Conclusions Clinic-based structured group education delivered by staff using psychological techniques had perceived benefits for parents and young people. Staff and families considered it a valuable intervention, yet uptake was poor and the burden on staff was high. Recommendations are made to inform issues related to organization, design, and delivery in order to potentially enhance the impact of CASCADE and future programs. Current Controlled Trials ISRCTN52537669.

Effectiveness of a structured educational intervention using psychological delivery methods in children and adolescents with poorly controlled type 1 diabetes: a cluster-randomized controlled trial of the CASCADE intervention

Introduction Type 1 diabetes (T1D) in children and adolescents is increasing worldwide with a particular increase in children <5 years. Fewer than 1 in 6 children and adolescents achieve recommended glycated hemoglobin (HbA1c) values. Methods A pragmatic, cluster-randomized controlled trial assessed the efficacy of a clinic-based structured educational group incorporating psychological approaches to improve long-term glycemic control, quality of life and psychosocial functioning in children and adolescents with T1D. 28 pediatric diabetes services were randomized to deliver the intervention or standard care. 362 children (8–16 years) with HbA1c≥8.5% were recruited. Outcomes were HbA1c at 12 and 24 months, hypoglycemia, admissions, self-management skills, intervention compliance, emotional and behavioral adjustment, and quality of life. A process evaluation collected data from key stakeholder groups in order to evaluate the feasibility of delivering the intervention. Results 298/362 patients (82.3%) provided HbA1c at 12 months and 284/362 (78.5%) at 24 months. The intervention did not improve HbA1c at 12 months (intervention effect 0.11, 95% CI −0.28 to 0.50, p=0.584), or 24 months (intervention effect 0.03, 95% CI −0.36 to 0.41, p=0.891). There were no significant changes in remaining outcomes. 96/180 (53%) families in the intervention arm attended at least 1 module. The number of modules attended did not affect outcome. Reasons for low uptake included difficulties organizing groups and work and school commitments. Those with highest HbA1cs were less likely to attend. Mean cost of the intervention was £683 per child. Conclusions Significant challenges in the delivery of a structured education intervention using psychological techniques to enhance engagement and behavior change delivered by diabetes nurses and dietitians in routine clinical practice were found. The intervention did not improve HbA1c in children and adolescents with poor control. Trial registration number ISRCTN52537669, results.

National training resources for newborn blood spot screening

Policy decisions to expand newborn screening and support informed choice prompted a review of information for parents and resources to support health professionals. The UK Newborn Screening Programme Centre conducted a needs assessment to identify training needs. We took into account existing reports of training needs as well as conducting our own survey of Midwifery Schools and screening laboratories. Prior evaluations, and our own survey, suggested the need for national resources on newborn bloodspot screening, rather than an additional national training programme. Based on these findings we developed resources that could be used within current training initiatives. These resources are now available to midwifery trainers for use alongside or in place of existing resources, as well as to individual midwives as part of a ‘self-learn’ package.