Boosting the impact of your qualitative research in feasibility studies for randomized controlled trials

Using qualitative research alongside clinical trials can help identify and explore uncertainties that could impact the intervention or trial design, which is of particular use when conducting a pilot or feasibility trial. A review published today in Pilot and Feasibility Studies outlines guidance for researchers to maximize the impact of qualitative research in feasibility studies for randomized controlled trials and here, we ask lead author Professor Alicia O'Cathain how the guidance was developed and what the future might hold for qualitative research.

Qualitative research explores people’s subjective experience of their lives. In evaluations it can be used to address questions such as ‘what is this intervention?’, ‘how are people applying this intervention?’ and ‘why is this intervention effective or not effective?’. Therefore, the impact of qualitative research to complement quantitative study results should not be underestimated; it helps researchers get down to the nitty-gritty.

A review published today in Pilot and Feasibility Studies outlines guidance for researchers to maximize the impact of qualitative research in feasibility studies for randomized controlled trials.

Professor Alicia O'Cathain,
Professor Alicia O’Cathain, Director of Health Services Research in the School of Health and Related Research, University of Sheffield.

Here, we interview lead author Professor Alicia O’Cathain. Alicia is the Director of Health Services Research in the School of Health and Related Research, University of Sheffield (UK).

She leads research programs in emergency and urgent care and the development and evaluation of complex interventions for long term conditions.

How can qualitative research contribute to feasibility studies for randomized controlled trials?

Qualitative research has a wide range of uses alongside trials. This is clearly documented in the research literature. It can help to identify problems and solutions with the intervention and the trial processes at the pre-trial phase.

This can result in saving money and energy running large expensive trials of interventions that have little chance of working or little chance of recruiting enough patients because it helps to optimize interventions and improve recruitment (among many other things).

Why was it necessary to develop guidance for qualitative research in feasibility studies for randomized controlled trials?

Health researchers have been using qualitative research with trials for decades. Guidance has been written over the years to help researchers undertake high quality research in this context, for example Medical Research Council (MRC) guidance on evaluation of complex interventions and MRC guidance on process evaluation.

We wrote this guidance because the feasibility part of the evaluation is important to get right and differs from the main trial. At the feasibility stage researchers can address a wide range of uncertainties and can take a dynamic approach, where changes are made to the intervention and trial processes during the feasibility study so that solutions are found to problems.

We wrote this guidance because the feasibility part of the evaluation is important to get right and differs from the main trial.


Professor Alicia O’Cathain

It is easy to fall into a pattern of undertaking interviews with health professionals and patients to explore feasibility and acceptability (a very important thing to do, but we can do more). We hope our paper helps researchers to think more widely.

How do you see the guidance being used within the research process?

We hope that researchers will read the guidance before they start designing their feasibility studies. We hope that the whole team will read it – the person leading the trial as well as the person leading the qualitative research.

We hope it can help researchers to think widely about their feasibility studies and all the options available to them. Then we’d like researchers to return to the guidance at different stages of their studies and reflect on whether they could do anything differently.

We don’t want researchers to use our paper as guidelines and think they have to do everything we say within the paper. We’ve written it to help researchers to reflect on how they do this work so they learn as much as possible about the uncertainties facing them before they run their full trials.

It is timely to reflect on how we do this work in practice and to improve on what we do so the field can develop and new researchers can learn from this work.


Professor Alicia O’Cathain

What challenges did you face during the development of this guidance?

The whole field of feasibility studies for trials is challenged by the variety of language researchers use: feasibility trials, pilot trials, exploratory trials, Phase II trials, and formative research. We had to make sure we acknowledged this and were clear that we were focusing on the work researchers do in preparation for the full trial.

How do you see the field of qualitative research with trials developing in future years?

Researchers have done a lot of qualitative research in feasibility studies for trials and have published this work. There is considerable expertise and experience to draw on internationally.

It is timely to reflect on how we do this work in practice and to improve on what we do so the field can develop and new researchers can learn from this work. We see the guidance as contributing to this process and hope that it inspires other researchers to reflect on this important part of the trial endeavor.


 

Interested in qualitative methods and research? Pilot and Feasibility Studies’ sister-journals, Trials and Systematic Reviews, are calling for papers to the new cross-journal series ‘Qualitative Methods, Trials and Systematic Reviews‘.

View the latest posts on the On Medicine homepage

Comments

By commenting, you’re agreeing to follow our community guidelines.

Your email address will not be published. Required fields are marked *