Developing and Evaluating Complex Interventions: New - IReSP
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MRC/CSO Social and Public Health Sciences Unit, University of Glasgow.
Developing and Evaluating Complex Interventions: New GuidancePeter CraigInstitut de Recherche en Santé Publique, Paris, 29 January2015
MRC/CSO Social and Public Health Sciences Unit, University of Glasgow.OutlineWhat is a complex intervention?
A phased approach•
Development
Feasibility and piloting
Evaluation
Implementation
Recent developments
Forthcoming events
MRC/CSO Social and Public Health Sciences Unit, University of Glasgow.The UK Medical Research Council guidance
MRC/CSO Social and Public Health Sciences Unit, University of Glasgow.What is a complex intervention?
Number of interacting
componentsNumber and difficulty of
behaviours involvedNumber of groups or
organisational levels targetedNumber and variability of
outcomesDegree of flexibility or
tailoring permittedGood theoretical grasp of
the change processImplementation vs.
intervention failureIndividual variation may
reflect higher level processesA range of outcome
measuresInterventions may work
better if adaptation to local context is permittedMRC/CSO Social and Public Health Sciences Unit, University of Glasgow.Evaluating complex interventions
MRC/CSO Social and Public Health Sciences Unit, University of Glasgow.Developing an interventionDevelop interventions systematically•
Use best available evidence, ideally from systematic review(s)Develop theoretical understanding of process of
changeModel process and outcomes
An iterative, not necessarily linear process•May go "back" to an earlier phase at any point
Implementation considerations should guide all phases• "Would it be possible to use this?" MRC/CSO Social and Public Health Sciences Unit, University of Glasgow.Feasibility and piloting MRC/CSO Social and Public Health Sciences Unit, University of Glasgow.Feasibility studies Research done before a main study to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study, e.g.• standard deviation of the outcome measure, which may be needed to estimate sample size; willingness of participants to be randomised/willingness of clinicians to recruit participants; number of eligible patients, carers or other appropriate participants; characteristics of the proposed outcome measure follow-up rates, response rates to questionnaires, adherence/compliance rates, ICCs for cluster trials, etc. MRC/CSO Social and Public Health Sciences Unit, University of Glasgow.Pilot studies A version of the main study that is run in miniature to test whether the components of the main study can all work together Focused on the processes of the main study, for example to ensure recruitment, randomisation, treatment, and follow-up assessments all run smoothly A pilot will resemble the main study in many respects, including an assessment of the primary outcome. MRC/CSO Social and Public Health Sciences Unit, University of Glasgow.Evaluation MRC/CSO Social and Public Health Sciences Unit, University of Glasgow.Assessing effectivenessChoosing an appropriate evaluation design•
Trials are the gold standard, but there ARE alternatives to the classical RCT, e.g:•Cluster randomisation
Stepped wedge designs
Preference designs
Randomised consent
Non-randomised designs
With the exception of cluster RCTs these are rare, but stepped wedge designs allow randomisation to be built into large scale implementation and deserve to be more widely used.MRC/CSO Social and Public Health Sciences Unit, University of Glasgow.Understanding the change process