Summary of findings from review of studies
Around 3% of UK trials on themRCT database reported using qualitative research. In proposals to funders, we recognise that researchers are often constrained by the necessity of providing detailed information about how the trial will be conducted and the lack of space available on application forms. That being said, there were still some concerns about how the qualitative research was described. The stated aim and rationale for using qualitative research in proposals broadly aligned with ourfindings in Chapter 3. The framework of uses of qualitative research was sometimes difficult to apply because of the vagueness of statements in some proposals. In terms of stated aims, we identified an additional category of patient and public involvement that was not found in the systematic mapping review and more generic statements about the acceptability and implementation of the intervention, and the experiences and views of participants that we were unable to categorise more specifically. We did notfind examples of the following subcategories found in the systematic mapping review: perceived value and benefits of the intervention, acceptability of the intervention in principle, diversity of participants, adaptation of the trial to local context, impact of the trial on staff, researchers and participants, and the accuracy of measures. TABLE 32 Qualitative research infinal study reports
Impact Number
Yes, impact on the trial 14
Facilitated recruitment or explained why poor 3 Identified lack of acceptability or acceptability of intervention 2 Identified lack of acceptability of trial design 2
Qualified or explained trialfindings 6
Modified way intervention was implemented 1
Impact unclear 1
Report too short 4
No mention of qualitative research 3
Suggested improvements to proposals include giving an explicit rationale for using the qualitative research, giving space to describe the sample size and analysis and resources, and specifying the use of experienced qualitative researchers. The number of interviews or focus groups planned in some of the proposals seemed extremely high, highlighting a potential feasibility issue for some studies in completing the
planned data collection or analysing a large volume of data successfully. It may be important for funders to question whether or not the qualitative data is being subject to quantitative criteria when large samples are proposed. If the trial or project manager and general researchers on the trial are to undertake the qualitative work, this suggests that there may be a lack of training and expertise for the qualitative work, indeed, particularly in the case of the trial manager the qualitative research risks being subsumed by the trial. Even though all the proposals we included were funded, we suggest that the lack of information about costs and resources means that it may be difficult for funders to see that the qualitative research is adequately resourced, whether or not it is feasible to complete, or if it provides value for money.
The impact of the qualitative research on the trial was much more obvious infinal reports than in qualitative articles reported inChapter 3. This component of the study also highlighted the complex context of doing qualitative research with trials, showing how some qualitative research is added after the trial is funded, some is not conducted as planned and some qualitative research is not published in the final report.
Review of studies in context of other research
Lewinet al.8concluded from a review of reports and publications of 100 trials of complex interventions that few used qualitative research. Their study found qualitative research for 30% of trials, which was much higher than our study. This may be explained by their focus on complex interventions because qualitative research may be more commonly undertaken with these types of trials than clinical trials, or because they undertook more strategies to identify the qualitative research compared with our electronic search of a database. Our low percentage of 3% was much more similar to Flemminget al.,7who found that less than 1% of 146 trials in palliative care in a systematic review used qualitative research.
Research commissioners make decisions about funding studies based on application forms with detailed proposals. A search of the literature revealed few articles related to writing proposals for qualitative research in general or specifically related to qualitative research combined with trials. Sandelowski and Barroso140refer to the process of writing qualitative research proposals as‘artful design’that requires ‘reflexivity, elegant expression, imaginative rehearsal, and strategic disarmament’in order to neutralise any anticipated concerns reviewers may have. They argue that the proposal must demonstrate the researchers’ knowledge of the methods andfield while demonstrating awareness and respect for their audience. They point out a tension between the emergent nature of the qualitative research and the planning of the research, with the need to show the significance of the research to be undertaken. That is, they put store by the rationale for doing the work. Connelly and Yoder141identify a number of common failings in qualitative proposals which we also found in the proposals in our study such as inadequate explanation of methodological techniques and lack of rationale for the use of qualitative methodology. The lack of description of sample size and analysis has been found for mixed methods research more generally,142 highlighting the difficulties research commissioners may face when deciding on the quality of
qualitative research.
Strengths and limitations of review of studies
It is unusual to assess the research proposals submitted to funders. Yet the proposal is the starting point of any study and shapes the utility of the research. We assessed the proposals of funded studies and cannot say how they compare with those of unfunded studies but would suggest they are likely to be superior. Our study had three limitations. First, qualitative research undertaken with trials may not be identified on the database we used, underestimating the amount of this type of research that occurs. Second, our response rate was poor, particularly for thefinal reports, leaving us with small numbers and the likelihood of non-response bias. Third, requesting full application forms with proposals would have given us a more comprehensive and consistent set of documents for use in our study.
Conclusions and implications of review of studies
A proposal without a solid rationale for undertaking the qualitative research with the trial suggests that the qualitative research and its relationship to the trial have not been properly thought through. All the proposals included in our study were successful in that they were funded. However, we would still suggest that it is insufficient to state the aims and rationale of the qualitative research without reference to the details of who will carry out the qualitative research or how it will be conducted and resourced, all of which are important to enable reviewers and research commissioners to make a confident decision about whether or not to fund the trial with qualitative research. We summarise ourfindings here to offer guidance for researchers and research commissioners for the content of proposals relating to the qualitative research undertaken with trials (Table 33).
TABLE 33 Guidance for researchers and commissioners on writing proposals for qualitative research and trials
Aspect of design Recommended details
Aim and rationale Describe the aim of the qualitative research and its rationale. Include a statement addressing the ways in which it‘adds value’to the trial
As far as possible, make aims specific to the trial, for example‘to explore patient views on adherence’rather than general, for example‘to explore patient experiences’
Methods Provide a clear account of the proposed methods of data collection including the location and timing of data collection, the skills and seniority of the person who will undertake data collection and the process of obtaining consent from participants
Describe the status and scale of the proposed qualitative research including a clear rationale for the sampling method, sample size and how participants will be selected
Describe and reference the proposed analysis methods and give a clear rationale for the approach to be taken
Integration with trial Identify the 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 Costs Describe the broad marginal 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