QUAlitative Research in Trials - the QUART Study

The way in which researchers look at the effectiveness of health care has changed over time. They are more likely to use qualitative methods (interviews, focus groups, observation) with randomised controlled trials (RCTs). For example interviews with patients might be used to help develop treatments and services which fully meet their needs, explore how treatments are used by both patients and staff in the real world, or help to interpret the study results. In practice, researchers may be using qualitative research to ‘add value to RCTs‘, or as an additional piece of research focused solely on the disease or patient group. The use of qualitative research methods requires closer inspection if we are to understand the benefits that a shift to a mixed methods approach (this combination of qualitative methods and RCTs) might offer. 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 studies 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. Initial searches suggest that we will find around 100-200 relevant studies.

We will extract information from the articles, proposals and reports to describe and categorise the different ways in which qualitative methods are currently used. The study will provide examples of the successful use of qualitative methods in RCTs; 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 best use qualitative methods within trials. The overall aim is to inform how we do research to improve health care.

Guidance on the evaluation of complex interventions has promoted the use of qualitative methods with randomised controlled trials (RCTs) of healthcare interventions. For example qualitative methods might be used to facilitate RCT design, explore context issues, and aid the interpretation of 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 offers trialists. 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 identify journal articles that report the use of qualitative methods in the context of an RCT. Second, we will search the mRCT database of registered trials to find reports and protocols that incorporate the use qualitative methods. Initial scoping suggests that we will find 100-200 relevant studies. We will extract data from articles and protocols to describe and conceptually 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. Third, we will undertake a survey of trials which appear not to have qualitative research included to identify the prevalence of ‘invisible qualitative components‘. Finally, we will undertake 15-25 semi-structured telephone interviews with researchers from a purposive sample of the studies identified. The aim of the interviews will be to explore in depth how to maximise the value of qualitative research with trialsstudy will provide examples of the successful uses of qualitative methods in RCTs, judged by their impact on trial design or substantive 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 overall aim is to inform design and commissioning of mixed methods approaches to RCTs.