An implementation research agenda

In October 2006, the Chief Medical Officer (CMO) of England asked Professor Sir John Tooke to chair a High Level Group on Clinical Effectiveness in response to the chapter 'Waste not, want not' in the CMOs 2005 annual report 'On the State of the Public Health'. The High level group made recommendations to the CMO to address possible ways forward to improve clinical effectiveness in the UK National Health Service (NHS) and promote clinical engagement to deliver this. The report contained a short section on research needs that emerged from the process of writing the report, but in order to more fully identify the relevant research agenda Professor Sir John Tooke asked Professor Martin Eccles to convene an expert group – the Clinical Effectiveness Research Agenda Group (CERAG) – to define the research agenda. The CERAG's terms of reference were 'to further elaborate the research agenda in relation to pursuing clinically effective practice within the (UK) National Health Service'.

Terminology is a problem in both the practice of, and researching into, clinical effectiveness. The high level group uses the term 'clinical effectiveness' as it built on the terminology used within the CMO's report. However, a study of 33 applied research funding agencies across nine countries identified 29 terms used to refer to some aspect of the processes around clinically effective practice [1]. This confusion has been compounded by the recent prominence of 'Translational Research', and the description of the first and second translation gaps. Given the balance of scientific endeavour and funding, the term 'Translational Research' is mainly thought of as the T1 bench to bedside process of transferring basic science knowledge into new drugs and technologies. Attracting about 1% of the research funding devoted to T1 research the T2 Translational Research is the process of taking current scientific knowledge and ensuring it is applied in routine clinical care [2].

Within the UK, the terms 'Implementation' and 'Implementation Research' seem to be the best recognised. Therefore, as a focus for its deliberations the CERAG adopted the following definition:

'Implementation Research is the scientific study of methods to promote the systematic uptake of clinical research findings and other evidence-based practices into routine practice, and hence to improve the quality (effectiveness, reliability, safety, appropriateness, equity, efficiency) of health care. It includes the study of influences on healthcare professional and organisational behaviour.' (adapted from Implementation Science http://www.implementationscience.com/info/about/ accessed 10 February 2009).

This editorial presents the summary of the group's report and recommendations; the full report is available as Additional File 1.

The findings from clinical and health services research can not change population health outcomes unless health care systems, organizations, and professionals adopt them in practice [3]. A consistent finding is that the transfer of research findings into practice is unpredictable and can be a slow and haphazard process. The relative inattention to implementing what we know is costing lives. There is an imbalance between investment in the development of new drugs and technologies versus improving the fidelity with which care is delivered.

In a structured review of healthcare professionals views on clinician engagement in quality improvement, Davies et al. identified 86 empirical reports relevant to the review [4]. They report that the literature suggests: healthcare professionals are heterogeneous in relation to their definition of quality; their perception of the need for quality improvement; their attitudes to quality improvement initiatives; their attitudes to clinical guidelines and evidence-based practice. In addition, they have a limited understanding of the concepts and methods of quality improvement, and quality improvement is often the scene of turf battles. Under the heading of perceived barriers, they also stated that 'many of the identified barriers arise from the well-documented problems of working effectively between and across health professions. This means that although more time and more resources may be necessary or helpful (directly and in their explicit recognition of healthcare professionals' concerns), they are unlikely to be sufficient on their own to overcome the substantial barriers to clinicians' active engagement in successful quality improvement'. Healthcare professionals are an important part of the organisation in which they work (and are subject to organisational policies, procedures, and cultures); this review offers a partial explanation for the persistent quality gaps and also supports the contention that it is unlikely that this will change spontaneously.

Recognition of quality gaps has led to increased interest in more active implementation strategies. Over the past 10 years, a body of Implementation Research has developed [5–7]. This demonstrates that interventions can be effective, but provides less information to guide the choice or optimise the components of such complex interventions in practice [8]. While the effectiveness of interventions varies across different clinical problems, contexts, and organizations, studies provide scant theoretical or conceptual rationale for their choice of intervention [9], and only limited descriptions of the interventions and contextual data [6]. Research on economic and political approaches to change is scarce [10], and it is therefore not surprising that little is known about how best to integrate disease and case management interventions into existing healthcare at the system level. Thus, the science of Implementation Research is still a work in progress, largely due to the fact that it is a relatively young science.

Internationally, Implementation Research is a recognised area of funding within other healthcare systems; this is not the case in the UK. The Cooksey Report [11] suggested a UK annual research budget (Public sector and major charities) of just over £2 billion. The proportion spent on health services (as opposed to biomedical or clinical) research in general is small. While there have been a number of previous funding programmes for Implementation Research within the UK, none are current. The proportion of annual research money devoted to Implementation Research is impossible to quantify; it is likely to be of the order of a maximum of a few millions pounds per year.

The Cooksey Report [11], having identified the need for implementation and Implementation Research, offers a sound basis on which to elaborate the Implementation Research agenda as a core part of a research agenda of key relevance to the NHS.

One of the major problems with not having a clearly identified, named Implementation Research funding stream is that the whole area loses 'profile'; the issues become blurred and the central focus of the routine uptake of findings, from clinical research programmes into routine care, becomes lost to research enquiry. In countries where there is a named, dedicated, funding stream (e.g., Canada, Australia) the research area has a higher profile with both researchers and with clinicians. There is the potential for senior researchers to establish programmes of research (rather than doing one-off studies), junior researchers to make it a career choice, and clinicians to become willing collaborators, thereby facilitating the spread of knowledge and the improvement of methods.

In elaborating the Implementation Research agenda the, CERAG identified five important overarching considerations that should influence thinking about, and commissioning of, Implementation Research.

First, it is important to consider the multiple levels at which healthcare is delivered and the interplay between them in their cultural context [12].

Second, Implementation Research centrally involves the study of changing behaviour and maintaining change – in organizations, and the groups and individual healthcare professionals within them.

Third, the use of theory in Implementation Research offers (at least) three important potential advantages. Theories offer a generalisable framework that can apply across differing settings and individuals; they offer the opportunity for the incremental accumulation of knowledge; and they offer an explicit framework for analysis. The CERAG agreed that appropriate consideration of theory was an important element of Implementation Research. As well as a more thoughtful use of theory, there is a need to work through the various stages of using theory and resolving such apparently simple issues as what it means for an intervention to be theory-based or what is the theoretical basis of behaviour change.

Fourth, frameworks are potentially useful tools for considering the issues that a research agenda needs to address [13]. Inevitably there is no one ideal, universally accepted framework that will fit all purposes; different frameworks will often reflect different purposes, disciplinary, or philosophical standpoints, and so will appeal to different groups or individuals.

Fifth, a general complaint of implementation studies (often trials) is that the need for experimental control, maximising internal validity, compromises external validity. As ever, the balance of considering these two dimensions of validity depends on the question that is being answered at the time [14].

This discussion of the research agenda is aimed primarily at commissioners of research, but will also be of relevance to a broader range of policy makers and researchers. While this report has been discussed and written in the context of the UK National Health Service and the National Institute for Health Research (NIHR) it is possible that a variety of other research-commissioning organisations could use it to identify areas that are a priority for them. However, it has been considered in its entirety and, in terms of programmatic commissioning, a piecemeal approach to addressing it could leave important areas unaddressed.