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Designing, delivering and disseminating pragmatic Randomised Controlled Trials of ‘complex’ interventions
Randomised controlled trials (RCTs) are one of the most elegant and powerful research tools available, yet it is increasingly recognised that the archetypal RCT is ill-equipped to evaluate ‘complex’ interventions. To remain relevant, researchers need be aware of developments in healthcare evaluation and require an understanding of the role of research evidence from end users’ perspectives (e.g. patients, clinicians, guideline developers, policymakers). This workshop reviews recent advances in trial methodology, focusing on the pragmatic RCT, and explores broader currents of contemporary thinking that are shaping healthcare research.
09:30 Registration/Tea and Coffee
10:00 Workshop starts (there will be a break for lunch)
16:30 Workshop ends
We begin by looking at the classic explanatory RCT, critically appraising its strengths and weaknesses. Next we consider changes in the nature of healthcare treatments, and ask what a ‘complex’ intervention is and what the implications of such interventions are for trial design? We review the salient features of pragmatic RCTs and related approaches [e.g. field experiments; practical behavioural trials] that seek to generate evidence, useful to end-users, of the effectiveness of non-standardised, multi-component interventions. We challenge the notion of a universal Hierarchy of Evidence and explore the position of pragmatic RCTs in the broader research process with reference to the MRC Framework for Developing Complex Interventions. We examine tools that can help plan pragmatic RCTs [e.g. CONSORT extension for pragmatic trials; PRECIS] and assess some of the practical challenges involved in the design and delivery of these trials, based on first-hand experience. Finally, we reflect on how current ideas about the purpose, scope and ethics of healthcare research [e.g. Evidence-Based Medicine; Translational Research; Implementation Science; Research Impact agenda; Public-Patient Involvement] create further challenges for applied healthcare research.
Learning outcomes and objectives
- Be able to critically appraise the strengths and weakness of explanatory RCTs and understand the types of research questions they are suited to address.
- Understand what is meant by a ‘complex’ intervention and recognise the implications that such interventions present for trial design.
- Be able to explain the explanatory-pragmatic continuum and describe the key features and functions of an idealised pragmatic RCT.
- Be able to critically discuss the idea of a universal Hierarchy of Evidence and explain the role of pragmatic RCTs within the MRC Framework(s).
- Be able to discuss prevalent discourses relevant to trial methodology and understand the implications for researchers planning a pragmatic RCT.
Although most of the teaching material focuses on healthcare interventions and contexts, the workshop is suitable for a wide range of psychologists and applied researchers evaluating ‘complex’, ‘behavioural’ or ‘social’ interventions in health, psychotherapeutic/counselling, educational, organisational or community settings.
Some reading (3-5 papers) with be required ahead of the workshop to ensure that all participants have a shared understanding of key concepts in clinical trial methodology to enable the first session (which will both review and extend this knowledge) to proceed on schedule, and to allow participants to engage with the group exercises. These papers will be emailed to participants at least 3 weeks ahead of the workshop.
Facilitator: Dr Martin Cartwright Cpsychol
Since completing an MSc in Health Psychology in 2000, I have gained in-depth knowledge and experience of a broad range of study methodologies and trial designs.
I have collaborated on several substantial funding applications for programmes of research involving multiple study designs combined to reflect the MRC Framework.
I have experience of conducting longitudinal cohort studies employing different sampling approaches and data collection procedures.
I was Project Coordinator on the largest and most comprehensive evaluation ever funded by the Department of Health which comprised two large-scale, pragmatic cluster-randomised trials of complex interventions (‘telehealth’ and ‘telecare’) with multiple nested designs.
I have organised training workshops as a member of the BREATHE* organising committee (2003 & 2004), and I have delivered numerous departmental seminars, conference presentations and training events on a range of topics (e.g. a day of training on Health Psychology models to trainee Clinical Psychologist at Birmingham University, 2009).
* BREATHE = British REsearch And Training in Health psychology
- DCP Members £66.67
- DHP Members £66.67
- BPS Members £92.50
- Non-members £118.33
How to book:
Please note: online bookings will close 24 hours prior to the event. Please call +44 (0)116 2529512 for availability after this point.
To pay by cheque or request an invoice complete and return the registration form.
Please note that we are only able to accept invoice requests at least 6 weeks before the event date.
Tel: +44 (0)116 252 9925
Fax: +44 (0)116 227 1314