A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance (original) (raw)
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Health Technology Assessment, 2021
BackgroundThe 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.MethodsThere 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 re...
Trials, 2014
The Medical Research Councils' framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach b...
Guidance on how to develop complex interventions to improve health and healthcare
BMJ Open
ObjectiveTo provide researchers with guidance on actions to take during intervention development.Summary of key pointsBased on a consensus exercise informed by reviews and qualitative interviews, we present key principles and actions for consideration when developing interventions to improve health. These include seeing intervention development as a dynamic iterative process, involving stakeholders, reviewing published research evidence, drawing on existing theories, articulating programme theory, undertaking primary data collection, understanding context, paying attention to future implementation in the real world and designing and refining an intervention using iterative cycles of development with stakeholder input throughout.ConclusionResearchers should consider each action by addressing its relevance to a specific intervention in a specific context, both at the start and throughout the development process.
Framework for design and evaluation of complex interventions to improve health
British Medical Journal, 2000
Randomised controlled trials are widely accepted as the most reliable method of determining effectiveness, but most trials have evaluated the effects of a single intervention such as a drug. Recognition is increasing that other, non›pharmacological interventions should also be rigorously evaluated. 1-3 This paper examines the design and execution of research required to address the additional problems resulting from evalua›
Evaluating complex health interventions: a critical analysis of the 'outcomes' concept
BMC Complementary and Alternative Medicine, 2009
Background The extent to which a health care intervention causes or facilitates health-related change is a key question in research. The need to quantify such change has led to the development of an increasing number of change indicators, to measure what have come to be known as 'outcomes'. In the context of medical research into the efficacy or effectiveness of an intervention the term 'outcomes' has often been interpreted to mean single endpoints with a linear cause and effect link to an external intervention. Discussion In this paper we present a critical analysis of the nature and interpretation of the 'outcomes' concept and of the assumptions that underpin it. Drawing on our own work and that of others, we analyse the problems that arise when the concept is applied to complex interventions and discuss the use of other models, such as programme theory, as a basis for alternative conceptualisations for indicators of change. Our analysis demonstrates that t...