QUAlitative Research in Trials - the QUART Study

Abstract

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.

Technical Summary

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.

Publications

10 25 50
 
Description Health Research Authority
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description MRC Methodology Hubs
Amount £13,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 09/2012 
End 08/2013
 
Description MRC Methodology Hubs CONDUCTII
Amount £2,000,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 04/2014 
End 03/2019
 
Description NIHR HS&DR
Amount £375,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 01/2015 
End 12/2016
 
Description STOP-OHSS (Shaping and Trialling Outpatient Protocols for Ovarian Hyper-Stimulation Syndrome): A feasibility study and randomised controlled trial with internal pilot to assess the clinical and cost-effectiveness of earlier active management of OHSS
Amount £1,782,753 (GBP)
Funding ID NIHR128137 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 12/2019 
End 11/2024
 
Description CONSORT for pilot trials 
Organisation St Mary's University, Twickenham
Country United Kingdom 
Sector Academic/University 
PI Contribution A spin off from the QUART study was funding from the MRC Hubs to look at feasibility studies and qualitative research. I was asked to join the CONSORT for pilot trials consensus group
Collaborator Contribution None
Impact Output of guidelines in process
Start Year 2013
 
Description MRC funded guidance for process evaluations 
Organisation Cardiff University
Country United Kingdom 
Sector Academic/University 
PI Contribution Helping to write guidance based on QUART study expertise
Collaborator Contribution They received funding from the MRC to write guidance and have led on this.
Impact Moore G, Audrey S, Barker M, Bond L, Bonell C, Cooper C, Hardeman W, Tinati T, Moore L, O'Cathain A, Wight D, Baird J. Process evaluation in complex public health interventions studies - the need for guidance. JECH 2013, in press.
Start Year 2013
 
Description talk to trial managers in England 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Talked to national group of trial managers about how best to use qualitative research in CTUs.
Year(s) Of Engagement Activity 2016