The Pilot and Feasibility Studies (PAFS) Collaboration, Queen Mary University London, UK

The Pilot and Feasibility Studies (PAFS) Collaboration is an international group coordinated from the Methodology Research Unit (MRU) at Queen Mary University of London, working alongside researchers from McMaster University in Canada and across other UK institutions including the University of Oxford, the Brighton and Sussex Medical School, Keele University, the University of Lancashire, the University of Aberdeen, the University of Bristol, and the University of Sheffield. The MRU aims for better research through better methods.

The PAFS Collaboration has produced impactful research on the definition of pilot studies that has been adopted by the UK National Institute for Health and Care Research and the Health Research Board in Ireland to guide researchers who are applying for funding. Most notably, the group have also developed and published the CONSORT extension for pilot and feasibility studies, established the Pilot and Feasibility Studies journal and created a website dedicated to PAFS.

A crucial part in the development of any intervention and trial is the preliminary work carried out before committing to a large-scale randomised controlled trial.

• A feasibility study asks whether something can be done, should we proceed with it, and if so, how.
• A pilot study asks the same question but has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale.

A pilot or feasibility study in advance of a future definitive study is helpful to investigate areas of uncertainty. For example, exploring the acceptability of a potential intervention, checking that participants can be recruited and retained, testing the study protocol, and exploring potential outcome measures. Assessing feasibility ensures that problems are less likely to be encountered in the definitive study, encourages methodological rigour, and results in higher-quality definitive studies.

The PAFS Collaboration continues to actively research areas relevant to the design of PAFS and supports PhD students conducting research in this area. This knowledge and expertise is shared via the PAFS website, developed to support those conducting pilot and feasibility studies using randomised and non-randomised designs and those carrying out methodological research on these types of studies. The PAFS website provides the resources for addressing questions such as how to choose the design, sample size, objectives and progression criteria for pilot and feasibility studies and a webinar series highlighting key points to consider when conducting pilot and feasibility studies prior to a definitive randomised controlled trial.

For more information on the PAFS Collaboration and to explore more resources please visit the PAFS website.