MRC QUART Study
Maximising the value of combining qualitative research and randomised controlled trials in health research (The QUART study)
- A O’Cathain School of Health and Related Research (ScHARR), University of Sheffield
- KJ Thomas ScHARR, University of Sheffield
- SJ Drabble ScHARR, University of Sheffield
- A Rudolph ScHARR, University of Sheffield
- J Hewison Leeds Institute of Health Sciences, University of Leeds
MRC Methodology Research Panel
Background: Researchers often undertake qualitative research with randomised controlled trials of health interventions, particularly when evaluating the effectiveness of complex interventions.
Aims: To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial endeavour of providing evidence of effectiveness of health interventions.
Design: A sequential mixed methods study with four components.
Methods: 1. Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials. 2. Systematic search of database of registered trials to identify studies combining qualitative research and trials. 3. Survey of 200 lead investigators of trials with no apparent qualitative research. 4. Semi-structured telephone interviews with 18 researchers purposively sampled from the first three methods.
Results: Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage. The articles focused on 22 aspects of the trial within 5 broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews, three models of study were identified: qualitative research as peripheral to the trial, qualitative research as ‘add-on’ to the trial, and a study with qualitative research and trial as essential components, with the latter model offering more opportunity to maximise the value of the qualitative research. Interviewees valued the use of qualitative research with trials and identified team structures and wider structural issues within health research as barriers to maximising the value of qualitative research.
Conclusion: A large number of articles were published between 2008 and 2010, addressing a wide range of aspects of trials. There were examples of this research affecting the trial by modifying interpretation of trial findings, developing and refining interventions for testing in the trial, and changing the measures used in the trial. However, researchers are not necessarily maximising the value of qualitative research undertaken with trials to the evidence of effectiveness of health interventions. They can maximise value by: promoting its use at the pre-trial stage to ensure that the intervention and trial conduct is optimised at the main trial stage; being explicit about the conclusions for the trial endeavour in peer-reviewed journal articles reporting the qualitative research; and valuing the contribution of the qualitative research as much as the trial. O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Goode J, Hewison J. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study – a mixed methods study. Health Technol Assess 2014;18(38).
O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Goode J, Hewison J. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study – a mixed methods study. Health Technol Assess 2014;18(38).
O’Cathain A, Goode J, Drabble SJ, Thomas KJ, Rudolph A, Hewison J. Getting added value from using qualitative research with randomised controlled trials: A qualitative interview study. Trials 2014;15:215.
Drabble SJ, O’Cathain A, Thomas KJ, Rudolph A, Hewison J. Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis. BMC Medical Research Methodology 2014, 14:24.
O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. BMJ Open 2013;3:e002889.
The MRC Hubs for Trials Methodology Research funded a day conference in November 2012 to disseminate the work. They also funded a workshop to develop guidance on using qualitative research at the pilot/feasibility stage of a trial. During this workshop links were made with a group developing guidance for process evaluations in public health trials and researchers interested in how clinical trials units undertake qualitative research. These associations have produced publications:
Moore G, Audrey S, Barker M, Bond L, Bonell C, Cooper C, Hardeman W, Moore L, O’Cathain A, Tannaze T, Wight D, Baird J. Process evaluation in complex public health intervention studies: the need for guidance. J Epidemiol Community Health 2013;0:1–2. doi:10.1136/jech-2013-202869
Cooper C, O’Cathain A, Hind D, Adamson J, Lawton J, Baird W. Conducting qualitative research within Clinical Trials Units: Avoiding potential pitfalls. Contemporary Clinical Trials 2014;38:338–343