Abstract
In 2015, the updated Medical Research Council (MRC) guidance emphasised the importance of conducting qualitative studies alongside RCTs and provided guidance to help researchers undertake this work. The MRC guidance along with methodological innovations such as the QuinteT Recruitment intervention, which uses mixed methods approaches to develop strategies for optimising recruitment to RCTs have highlighted the value of conducting qualitative research alongside trials.
There is now a large body of qualitative evidence which reports on the acceptability of individual interventions and/or the common barriers and facilitators to designing and delivering RCTs. These studies provide valuable, in-depth insights surrounding the reasons why trials may or may not be ‘successful’ both in terms of an intervention’s delivery, implementation and acceptability and the design and conduct of the trial itself. However, qualitative findings are often published separately to the results of the main trial as standalone chapters within funder reports and/or as separate journal articles. As a result, the extent that the qualitative evidence that is generated during a trial is used to aid the interpretation of trial findings and/or a trial’s design and delivery is uncertain.
In this study we will map and describe how qualitative research is being used alongside currently funded National Institute for Health Research RCTs. We will include any RCT that was published during 2021 in the Health Technology Assessment (HTA), Programme Grants for Applied Research (PGfAR) and Public Health Research (PHR) journals library as these are the main funders of health-related RCTs in the UK. We will use the advanced search page on the NIHR Journals library to identify relevant reports. Any RCT, published in 2021 in the HTA, PGfAR and PHR journals library will be eligible for inclusion so long as it includes a qualitative study (e.g. qualitative sub-studies, qualitative process evaluations, qualitative components of mixed methods process evaluations) that uses established methods of qualitative data collection (e.g. interviews) and analysis (e.g. thematic analysis). Two researchers will independently assess the reports in the database and undertake data extraction. Key information to be extracted may include: RCT study characteristics (aims, design, patient characteristics); qualitative study characteristics (aims, method of data collection and analysis); participant characteristics of included qualitative studies (e.g. numbers of participants, stakeholder groups included, whether underserved populations are represented); Details of how qualitative findings are reported (i.e. as separate chapters or as mixed methods chapters); Details of how qualitative findings have informed the design, conduct, or interpretation of trial findings (e.g. how did qualitative findings inform the design of a future trial when conducted during feasibility trials).
At the time of registration, preliminary searches had been conducted and the study protocol was in development.
Aim
To map and describe how qualitative research is used alongside Randomised Controlled Trials (RCTs). The study will include all RCTs that were published in National Institute for Health Research (NIHR) Health Technology Assessment (HTA), Programme Grants for Applied Health Research (PGfAHR) and Public Health Research (PHR) reports in 2021. Specific objectives of the study are:
- What proportion of RCTs included a qualitative study.
- What questions are qualitative studies posing when conducted alongside RCTs?
- What qualitative methods are being used by qualitative studies, which are conducted alongside RCTs?
- At what point during the trial is qualitative research being conducted?
- What populations and/or participant groups are included in qualitative studies of surgical trials?
o Are under-served populations represented in qualitative studies. If so, what strategies and/or methods to facilitate their inclusion are being used by qualitative studies?
- How are qualitative studies that are conducted alongside RCTs being reported?
- How are findings from qualitative studies being used to improve the design and conduct of trials.
o What strategies for improving the design and conduct of trials are being developed and how?
o How is the impact of these strategies evaluated and reported?
Intended Impact of the Study
This study will provide an overview of how qualitative research is currently being used alongside Randomised Controlled Trials. Findings from this study will be used to inform the development of a future grant application. We plan to publish our findings in a peer-reviewed academic journal.
Project Lead
Project Collaborators
Liz Cook
Catriona McDaid
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Study Funding/Support
Other(s): Unfunded