Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2015 Sep 7:1:32.
doi: 10.1186/s40814-015-0026-y. eCollection 2015.

Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

Alicia O'Cathain  1 , Pat Hoddinott  2 , Simon Lewin  3 , Kate J Thomas  1 , Bridget Young  4 , Joy Adamson  5 , Yvonne Jfm Jansen  6 , Nicola Mills  7 , Graham Moore  8 , Jenny L Donovan  7
Affiliations
Review

Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

Alicia O'Cathain et al. Pilot Feasibility Stud. .

Abstract

Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controlled trials. The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial. The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.

Keywords: Feasibility studies; Guidance; Pilot studies; Qualitative methods; Randomised controlled trial.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Key steps for qualitative research in a feasibility study for a trial
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. - PMC - PubMed
    1. Ioannidis JPA, Greenland S, Hlatky MA, Khoury MJ, Macleod MR, Moher D, et al. Research Waste series: increasing value and reducing waste in research design, conduct, and analysis. Lancet. 2014;383:166–75. - PMC - PubMed
    1. Soliman EZ, Mendis S, Dissanayake WP, Somasundaram NP, Gunaratne PS, Jayasingne IK, Furberg CD. A Polypill for primary prevention of cardiovascular disease: a feasibility study of the World Health Organization. Trials. 2011;12:3. - PMC - PubMed
    1. 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. - PMC - PubMed
    1. 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). - PMC - PubMed