BackgroundThe past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT) addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation).DiscussionIn this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential.SummaryThe NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.

BackgroundThis study is to identify, summarise and synthesise literature on the causes of the evidence to practice gap for complex interventions in primary care.DesignThis study is a systematic review of reviews.MethodsMEDLINE, EMBASE, CINAHL, Cochrane Library and PsychINFO were searched, from inception to December 2013. Eligible reviews addressed causes of the evidence to practice gap in primary care in developed countries. Data from included reviews were extracted and synthesised using guidelines for meta-synthesis.ResultsSeventy reviews fulfilled the inclusion criteria and encompassed a wide range of topics, e.g. guideline implementation, integration of new roles, technology implementation, public health and preventative medicine. None of the included papers used the term “cause” or stated an intention to investigate causes at all. A descriptive approach was often used, and the included papers expressed “causes” in terms of “barriers and facilitators” to implementation. We developed a four-level framework covering external context, organisation, professionals and intervention. External contextual factors included policies, incentivisation structures, dominant paradigms, stakeholders’ buy-in, infrastructure and advances in technology. Organisation-related factors included culture, available resources, integration with existing processes, relationships, skill mix and staff involvement. At the level of individual professionals, professional role, underlying philosophy of care and competencies were important. Characteristics of the intervention that impacted on implementation included evidence of benefit, ease of use and adaptability to local circumstances. We postulate that the “fit” between the intervention and the context is critical in determining the success of implementation.ConclusionsThis comprehensive review of reviews summarises current knowledge on the barriers and facilitators to implementation of diverse complex interventions in primary care. To maximise the uptake of complex interventions in primary care, health care professionals and commissioning organisations should consider the range of contextual factors, remaining aware of the dynamic nature of context. Future studies should place an emphasis on describing context and articulating the relationships between the factors identified here.Systematic review registrationPROSPERO CRD42014009410 Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-016-0396-4) contains supplementary material, which is available to authorized users.

Objective: Supporting patients' self care could have a major effect on the management of long-term conditions, which has led to worldwide interest in effective self care interventions. In England, self care support is being developed through the ''Expert Patients Programme'', which provides lay-led generic courses to improve patients' self care skills. However, the clinical and cost effectiveness of such courses remains unclear. Methods: Two-arm pragmatic randomised controlled trial design with waiting list control in community settings in England. 629 patients with a wide range of self-defined long-term conditions were studied. The lay-led self care support group involved 6-weekly sessions to teach self care skills. Primary outcomes were self-efficacy, reported energy and routine health services utilisation at 6 months. A cost-effectiveness analysis was also conducted. Results: Patients receiving immediate course access reported considerably greater self-efficacy and energy at 6-month follow-up, but reported no statistically significant reductions in routine health services utilisation over the same time period. The cost-effectiveness analysis showed that patients receiving immediate course access reported considerably greater health related quality of life, and a small reduction in costs. If a quality adjusted life year was valued at £20 000 ($39 191; J30 282), there was a 70% probability that the intervention was cost effective. Conclusions: Lay-led self care support groups are effective in improving self-efficacy and energy levels among patients with long-term conditions, and are likely to be cost effective over 6 months at conventional values of a decision-maker's willingness to pay. They may be a useful addition to current services in the management of long-term conditions.