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Abstract: In a cluster randomised controlled trial of a policy to provide community breastfeeding support groups in Scotland, breastfeeding rates declined in 3 of 7 intervention localities. From a preliminary study, we expected breastfeeding outcomes to vary and we prospectively used qualitative and quantitative methods to ask why. Ethnographic in-depth interviews, focus groups, observations and survey data were analysed to build seven embedded case studies. A pyramidal model of how primary health service organisations implemented the policy was constructed prior to knowing trial outcomes to minimise bias. Informed by a realist approach, the model explained variation in (a) policy implementation (b) the breastfeeding outcomes, whereas the quantity of intervention delivered did not. In the three localities where breastfeeding rates declined, negative aspects of place including deprivation, unsuitable premises and geographical barriers to inter-professional communication; personnel resources including staff shortages, high workload and low morale; and organisational change predominated (the base model tiers). Managers focused on solving these problems rather than delivering the policy and evidence of progress to the higher model tiers was weak. In contrast, where breastfeeding rates increased the base tiers of the model were less problematic, there was more evidence of leadership, focus on the policy, multi-disciplinary partnership working and reflective action cycles (the higher model tiers). We advocate an ethnographic approach to the design and evaluation of complex intervention trials and illustrate how this can assist in developing an explanatory model. More attention should be given to the complex systems within which policies and interventions occur, to identify and understand the favourable conditions necessary for a successful intervention. [Copyright &y& Elsevier]

Background: Delivering an intervention to a group of patients to improve health outcomes is increasingly popular in public health and primary care, yet "group" is an umbrella term which encompasses a complex range of aims, theories, implementation processes and evaluation methods. We propose a framework for the design and process evaluation of health improvement interventions occurring in a group setting, which will assist practitioners, researchers and policy makers. Methods: We reviewed the wider literature on health improvement interventions delivered to patient groups and identified a gap in the literature for designing, evaluating and reporting these interventions. We drew on our experiences conducting systematic reviews, intervention, mixed method and ethnographic studies of groups for breastfeeding and weight management. A framework for health improvement group design and delivery evolved through an iterative process of primary research, reference to the literature and research team discussion. Results: Although there is an extensive literature on group processes in education, work, politics and psychological therapies, far less is known about groups where the aim is health improvement. Theories of behaviour change which are validated for individual use are often assumed to be generalisable to group settings, without being rigorously tested. Health improvement or behaviour change interventions delivered in a group setting are complex adaptive social processes with interactions between the group leader, participants, and the wider community and environment. Ecological models of health improvement, which embrace the complex relationship between behaviour, systems and the environment may be more relevant than an individual approach to behaviour change. Conclusion: The evidence for effectiveness and cost-effectiveness of group compared with one-to-one interventions for many areas of health improvement in public health and primary care is weak or unknown. Our proposed framework is the first step towards advocating a more systematic approach to designing, evaluating and reporting interventions in group settings, which is necessary to improve this currently weak evidence base. This framework will enable policy makers and practitioners to be better informed about what works, how it works and in which contexts when aiming to improve health in a group setting. [ABSTRACT FROM AUTHOR]

Objective To assess the clinical effectiveness and cost effectiveness of a policy to provide breastfeeding groups for pregnant and breastfeeding women. Design Cluster randomised controlled trial with prospective mixed method embedded case studies to evaluate implementation processes. Setting Primary care in Scotland. Participants Pregnant women, breastfeeding mothers, and babies registered with 14 of 66 eligible clusters of general practices (localities) in Scotland that routinely collect breastfeeding outcome data. Intervention Localities set up new breastfeeding groups to "provide population coverage; control localities did not change group activity. Main outcome measures Primary outcome: any breast feeding at 6-8 weeks from routinely collected data for two pre-trial years and two trial years. Secondary outcomes: any breast feeding at birth, 5-7 days, and 8-9 months; maternal satisfaction. Results Between 1 February 2005 and 31 January 2007, 9747 birth records existed for intervention localities and 9111 for control localities. The number of breastfeeding groups increased from 10 to 27 in intervention localities, where 1310 women attended, and remained at 10 groups in control localities. No significant differences in breastfeeding outcomes were found. Any breast feeding at 6-8 weeks declined from 27% to 26% in intervention localities and increased from 29% to 30% in control localities (P=0.08, adjusted for pre-trial rate). Any breast feeding at 6-8 weeks increased from 38% to 39% in localities not participating in the trial. Women who attended breastfeeding groups were older (P<0.001) than women initiating breast feeding who did not attend and had higher income (P=0.02) than women in the control localities who attended postnatal groups. The locality cost was £13 400 (¿14 410; $20144) a year. Conclusion A policy for providing breastfeeding groups in relatively deprived areas of Scotland did not improve breastfeeding rates at 6-8 weeks. The costs of running groups would be similar to the costs of visiting women at home. [ABSTRACT FROM AUTHOR]

Abstract: Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this paper, we discuss how choosing which population cluster to randomise can impact on the practicalities of recruitment in primary care. We describe strategies developed through our experiences of recruiting primary care organisations to participate in a national randomised controlled trial of a policy to provide community breastfeeding groups for pregnant and breastfeeding mothers, the BIG (Breastfeeding in Groups) trial. We propose an iterative qualitative approach to recruitment; collecting data generated through the recruitment process, identifying themes and using the constant comparative method of analysis. This can assist in developing successful recruitment strategies and contrasts with the standardised approach commonly used when recruiting individuals to participate in randomised controlled trials. Recruiting primary care population clusters to participate in trials is currently an uphill battle in Britain. It is a complex process, which can benefit from applying qualitative methods to inform trial design and recruitment strategy. Recruitment could be facilitated if health service managers were committed to supporting peer reviewed, funded and ethics committee approved research at national level. [Copyright &y& Elsevier]