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
. 2018 Sep 25;8(9):e022233.
doi: 10.1136/bmjopen-2018-022233.

Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study

Amanda Jane Blatch-Jones  1 , Wei Pek  2 , Emma Kirkpatrick  3 , Martin Ashton-Key  1
Affiliations

Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study

Amanda Jane Blatch-Jones et al. BMJ Open. .

Abstract

Objectives: To assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs.

Study design: Cross-sectional study.

Setting: Both groups included NIHR HTA programme funded studies in the period 1 January 2010-31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study.

Main outcome measures: The proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of 'HTA funded' trials which used internal and external pilot and feasibility studies to inform the design of the trial.

Results: Group 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed were testing recruitment (100% in both groups), feasibility (83%, 100%) and suggestions for further study/investigation (83%, 100%). Group 2 identified 161 'HTA funded' applications: 59 cited an external pilot/feasibility study where testing recruitment (50%, 73%) and feasibility (42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study where testing recruitment (93%, 100%) and feasibility (44%, 92%) were the most common study elements reported.

Conclusions: 'HTA funded' research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.

Keywords: feasibility studies; health technology assessment; pilot studies; randomised controlled trials.

PubMed Disclaimer

Conflict of interest statement

Competing interests: ABJ and MAK are employed by the University of Southampton to work for NETSCC. ABJ is employed as the Senior Research Fellow for the Research on Research programme and has worked for NETSCC (and its predecessor organisation) in various roles since 2008. MAK is the scientific director at NETSCC and was an editor of the Health Technology Assessment journal. EK is employed by the University of Southampton and works at Southampton’s Clinical Trials Unit. EK worked for the Research on Research programme during June 2014 to December 2015. WP was a 4th Year BM5 Medicine student at the University of Southampton.

Figures

Figure 1
Figure 1
The number of studies identified, excluded and categorised for cohort 1.
Figure 2
Figure 2
Flow chart showing the number of Health Technology Assessment (HTA) funded applications for cohort 2.
See this image and copyright information in PMC

References

    1. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. The Lancet 2009;374:86–9. 10.1016/S0140-6736(09)60329-9 - DOI - PubMed
    1. Moher D, Glasziou P, Chalmers I, et al. . Increasing value and reducing waste in biomedical research: who’s listening? Lancet 2016;387:1573–86. 10.1016/S0140-6736(15)00307-4 - DOI - PubMed
    1. Cooper CL, Whitehead A, Pottrill E, et al. . Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials. Clin Trials 2018;15:189–96. 10.1177/1740774517752113 - DOI - PMC - PubMed
    1. Eldridge SM, Chan CL, Campbell MJ, et al. . CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016;2:64. - PMC - PubMed
    1. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract 2004;10:307–12. 10.1111/j.2002.384.doc.x - DOI - PubMed

Publication types

LinkOut - more resources