Using qualitative methods alongside trials of complex interventions Introduction Mixed methods, which include the use of qualitative methods alongside randomised control trials of complex interventions, are increasingly recognised as adding value to research studies 1-3 Despite increased interest, currently, UK funding bodies not offer specific guidance to applicants on how to present a proposal for qualitative research within an application for trial funding This short document summarises the benefits of including a qualitative component in an application for trial funding and offers a checklist for researchers on what to include in a proposal What can qualitative research add to an RCT? There are a wide range of reasons for and benefits of using qualitative methods alongside RCTs, before, during and after a trial (see Box below) A recent systematic mapping review of qualitative research undertaken with RCTs and published in peer-reviewed journals found that the temporal categories identified by Lewin and colleagues were in practice often more blurred (for example, it was hard to distinguish between ‘during a trial’ and ‘after a trial’), and the authors propose an alternative (but overlapping) framework for conceptualising the focus of qualitative research undertaken alongside trials (see Box 2) BOX 1: Ways in which qualitative methods can be used alongside randomised control trials Before a trial To explore issues related to the healthcare question of interest or context of the research To generate hypotheses for examination in the randomised controlled trial To develop and refine the intervention To develop or select appropriate outcome measures During a trial To examine whether the intervention was delivered as intended, including describing the intervention as delivered To “unpack” processes of implementation and change To explore deliverers’ and recipients’ responses to the intervention After a trial To explore reasons for the findings of the trial To explain variations in effectiveness within the sample To examine the appropriateness of the underlying theory To generate further questions or hypotheses Source: Box 2: Framework for conceptualising the contribution of qualitative research to RCTs Intervention content and delivery Pretrial development work relating to intervention content and delivery Exploring individual components of a complex intervention as delivered in a specific trial Developing models, mechanisms of action and underlying theories or concepts relating to an intervention in the context of a specific trial Exploring accounts of perceived value and benefits of intervention given by recipients and providers of the intervention Exploring stakeholder perceptions of the ‘in principle’ acceptability of an intervention Exploring stakeholder perceptions of the feasibility and acceptability of an intervention in practice Describing the fidelity, reach and dose of an intervention as delivered in a specific trial Identifying lessons for ‘real world’ implementation based on delivery of the intervention in the trial Trial design; conduct and processes Identifying ways of increasing recruitment and retention Identifying ways of broadening participation in a trial to improve diversity of population Improving understanding of how participants join trials and experience of participation Exploring stakeholders’ views of acceptability of a trial design Exploring stakeholders’ views of acceptability of a trial design in practice Strengthening the ethical conduct of a trial, for example, informed consent procedures Addressing local issues which may impact on the feasibility of a trial Understanding how the trial affects different stakeholders, for example, workload (NB See also RDS guidance of fidelity assessment, an emerging field of research) Outcomes Identifies the range of outcomes important to participants in the trial Explains differences in outcomes between clusters or participants in a trial Measures of process and outcome Assesses validity of process and outcome measures in the trial Explores why participants complete measures or not Incorporating into a proposal Contributes to the development of a new process and secondary outcome measures Target condition Explores the experience of having or treating a condition that the intervention is aimed at, or a related behaviour or belief Source: adapted from O’Caithin and colleagues cite specific studies they reviewed, giving examples of each of the above categories of focus, and providing illustrations of the type of qualitative research methods and findings in each case Tips for researchers on writing proposals for qualitative research undertaken alongside a trial As part of an MRC study on maximising the value of qualitative research in trials, Drabble et al undertook a documentary analysis of trial proposals that included qualitative research and were successfully funded by NIHR, MRC and Wellcome From their analysis they offer guidance on good practice for researchers considering a qualitative component to their study This guidance is summarised in Table Table 1: Guidance on writing proposals for qualitative research Aim Rationale Describe the aim of the qualitative research Where appropriate identify aims specific to the trial e.g ‘to explore patient views on adherence to the trial intervention’ rather than using general aims e.g ‘to explore patient experiences’ Describe the rationale for including qualitative research; identify areas of uncertainty to be explored Include a statement addressing the ways in which the aims of the qualitative Methods Integration with trial research will ‘add value’ to the trial Provide a clear account of the proposed methods of data collection including the location and timing of data collection, and the skills and seniority of the person who will undertake data collection Describe the sample frame, sampling method(s), and sample size Where the sample frame is trial participants, specify whether intervention, control or both will be included Describe and reference the proposed approach to analysis A rationale for the approach to be taken may be included Identify the qualitative research skills and seniority of the person who will undertake the analysis and write-up Outline suggestions for integrating and synthesising qualitative data / findings with the trial results Cost Describe the full costs of the qualitative research and highlight any dedicated equipment, software, staff, and transcription costs Leadership Identify which of the co-applicants will take overall responsibility for the qualitative research and describe their role in the design, data collection, analysis and write-up of the study Conclusion This short document has outlined the various benefits of including qualitative methods in a trial study proposal A number of Research Design Service advisers have expertise and experience in mixed methods study and can support applicants in developing their research proposal Jill Russell Research Design Service London Queen Mary University of London March 2014 References Lewin S, Glenton C, Oxman AD Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study BMJ 2009;339(sep10 1):b3496 doi: 10.1136/bmj.b3496 O'Cathain A, Thomas KJ, Drabble SJ, et al What can qualitative research for randomised controlled trials? A systematic mapping review BMJ Open 2013;3(6) doi: 10.1136/bmjopen-2013-002889 O'Cathain A, Murphy E, Nicholl J Why, and how, mixed methods research is undertaken in health services research in England: a mixed methods study BMC Health Serv Res 2007;7:85 doi: 10.1186/14726963-7-85 Drabble SJ, O'Cathain A, Thomas KJ, et al Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis BMC Med Res Methodol 2014;14:24 doi: 10.1186/1471-2288-14-24