scholarly journals Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update

2021 ◽  
Vol 25 (57) ◽  
pp. 1-132
Author(s):  
Kathryn Skivington ◽  
Lynsay Matthews ◽  
Sharon Anne Simpson ◽  
Peter Craig ◽  
Janis Baird ◽  
...  

Background The Medical Research Council published the second edition of its framework in 2006 on developing and evaluating complex interventions. Since then, there have been considerable developments in the field of complex intervention research. The objective of this project was to update the framework in the light of these developments. The framework aims to help research teams prioritise research questions and design, and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. Methods There were four stages to the update: (1) gap analysis to identify developments in the methods and practice since the previous framework was published; (2) an expert workshop of 36 participants to discuss the topics identified in the gap analysis; (3) an open consultation process to seek comments on a first draft of the new framework; and (4) findings from the previous stages were used to redraft the framework, and final expert review was obtained. The process was overseen by a Scientific Advisory Group representing the range of relevant National Institute for Health Research and Medical Research Council research investments. Results Key changes to the previous framework include (1) an updated definition of complex interventions, highlighting the dynamic relationship between the intervention and its context; (2) an emphasis on the use of diverse research perspectives: efficacy, effectiveness, theory-based and systems perspectives; (3) a focus on the usefulness of evidence as the basis for determining research perspective and questions; (4) an increased focus on interventions developed outside research teams, for example changes in policy or health services delivery; and (5) the identification of six ‘core elements’ that should guide all phases of complex intervention research: consider context; develop, refine and test programme theory; engage stakeholders; identify key uncertainties; refine the intervention; and economic considerations. We divide the research process into four phases: development, feasibility, evaluation and implementation. For each phase we provide a concise summary of recent developments, key points to address and signposts to further reading. We also present case studies to illustrate the points being made throughout. Limitations The framework aims to help research teams prioritise research questions and design and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. In many of the areas of innovation that we highlight, such as the use of systems approaches, there are still only a few practical examples. We refer to more specific and detailed guidance where available and note where promising approaches require further development. Conclusions This new framework incorporates developments in complex intervention research published since the previous edition was written in 2006. As well as taking account of established practice and recent refinements, we draw attention to new approaches and place greater emphasis on economic considerations in complex intervention research. We have introduced a new emphasis on the importance of context and the value of understanding interventions as ‘events in systems’ that produce effects through interactions with features of the contexts in which they are implemented. The framework adopts a pluralist approach, encouraging researchers and research funders to adopt diverse research perspectives and to select research questions and methods pragmatically, with the aim of providing evidence that is useful to decision-makers. Future work We call for further work to develop relevant methods and provide examples in practice. The use of this framework should be monitored and the move should be made to a more fluid resource in the future, for example a web-based format that can be frequently updated to incorporate new material and links to emerging resources. Funding This project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514).

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Rajalakshmi Lakshman ◽  
Simon Griffin ◽  
Wendy Hardeman ◽  
Annie Schiff ◽  
Ann Louise Kinmonth ◽  
...  

Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours.Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects.Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN:20814693Baby Milk Trial.


Evaluation ◽  
2018 ◽  
Vol 25 (2) ◽  
pp. 149-170 ◽  
Author(s):  
Sarah Louise Brand ◽  
Cath Quinn ◽  
Mark Pearson ◽  
Charlotte Lennox ◽  
Christabel Owens ◽  
...  

Medical Research Council guidelines recognise the need to optimise complex interventions prior to full trial through greater understanding of underlying theory and formative process evaluation, yet there are few examples. A realist approach to formative process evaluation makes a unique contribution through a focus on theory formalisation and abstraction. The success of an intervention is dependent on the extent to which it gels or jars with existing provision and can be successfully transferred to new contexts. Interventions with underlying programme theory about how they work, for whom, and under which circumstances will be better able to adapt to work with (rather than against) different services, individuals, and settings. In this methodological article, we describe and illustrate how a realist approach to formative process evaluation develops contextualised intervention theory that can underpin more adaptable and scalable interventions. We discuss challenges and benefits of this approach.


2021 ◽  
pp. postgradmedj-2021-139766
Author(s):  
Sarah Brewster ◽  
Richard Holt ◽  
Hermione Price

Healthcare interventions are complex, but have the potential to deliver more efficient, cost-effective care and improved health outcomes. Careful attention must be paid to their early planning and development to minimise research waste or interventions that fail to deliver what they set out to achieve. The Medical Research Council provides guidance to help intervention developers, encouraging an explicit and iterative approach. This article describes the Medical Research Council’s guidance and introduces two frequently used tools that further support the process of intervention design.


Sign in / Sign up

Export Citation Format

Share Document