MRC QUART Study
Maximising the value of QUAlitative Research in Trials – the QUART Study
Aim
To identify the contribution of qualitative research to RCTs to help researchers maximise the value of this approach in the future.
Team
- Professor Alicia O’Cathain, University of Sheffield (PI)
- Professor Kate Thomas, University of Leeds
- Professor Jenny Hewison, University of Leeds
Funder
Medical Research Council Methodology Programme.
Funding: £250,000.
Time period: 1 April 2010 for 2 years.
Summary
Guidance on the evaluation of complex interventions has promoted the use of qualitative methods (interviews, focus groups, observation) with randomised controlled trials (RCTs) of healthcare interventions. For example qualitative methods might be used to help develop interventions, explore how the intervention in used by both patients and staff in the real world, or help to interpret the trial results. In practice, researchers may be using qualitative research to add value to RCTs, or as an additional piece of research focused on the disease and patient group rather than the trial and the intervention under study. The use of qualitative research methods requires closer inspection if we are to understand the value and potential that a shift to a mixed methods approach (combination of qualitative and quantitative methods) might offer researchers who conduct trials. We will address the question `what work do qualitative methods do in RCTs?´
Examples of the use of qualitative methods in or alongside trials will be identified from two sources. First, we will undertake a systematic search of key databases to find journal articles that report the use of qualitative methods in the context of an RCT. Second, we will search databases of two major UK trial funders to find reports and protocols that use qualitative methods. This latter approach will identify the most up to date approach taken to qualitative methods in RCTs.
We will extract data from these documents to describe and categorise the different ways in which qualitative methods are currently used, and to explore the relationship between the qualitative component and the trial itself, using frameworks from both the mixed methods and complex interventions literature. We will interview 20 researchers from a purposive sample of these trials. The study will provide examples of the successful uses of qualitative methods in RCTs, judged by their impact on trial design or trial findings; raise awareness of how qualitative methods are used to assist (or not) the evidence base produced by trials; and identify ways in which researchers can further exploit the contribution of qualitative methods used within trials. The ultimate aims are to inform design and commissioning of mixed methods approaches to RCTs.