Pilot and feasibility studies are often criticized as being underpowered definitive trials, how do you think having a journal specifically dedicated to pilot and feasibility studies can change this view?
Having a journal specifically dedicated to pilot and feasibility studies will improve the methodological rigour of these studies. It will highlight their importance when preparing for a definitive trial, and create a platform for discussing how issues of uncertainty concerning definitive trials can be studied and addressed.
Pilot and Feasibility Studies will enable researchers to reflect on each other’s work and suggest new innovative ways of working to address feasibility concerns.
Displaying the range of feasibility objectives that others use, and highlighting how difficulties have been resolved when planning a definitive trial, will not only avoid repetition of research but also hopefully help make underpowered definitive trials a thing of the past.
How can a more complete evidence-base for pilot and feasibility studies advance further biomedical research?
By taking a scientific approach to the conduct of pilot and feasibility studies, and by publishing the findings, a more complete evidence-base is created.
Until the launch of this journal, there was no dedicated place for the publication of pilot and feasibility work. It is well known that these kinds of studies suffer from publication bias; the vast majority of pilot and feasibility studies do not get published, only a small minority do.
Those that are published are found across a wide range of subject-specific journals; journals that researchers from outside the subject area are unlikely to read. This confounds the sharing of new methods knowledge. Having them all in one place facilitates learning and sharing of new knowledge across disciplines, and plays an important role in the advancement of further biomedical research.
… Pilot and Feasibility Studies will enable researchers to reflect on each other’s work and suggest new innovative ways of working to address feasibility concerns…
The journal Pilot and Feasibility Studies also accepts study protocol submissions – why do you think it is important that these are published?
Study protocols are a way of knowledge sharing at an early stage in the research process. Though many protocols may have already been reviewed by ethics committees or funding bodies, peer-review of study protocols for publication will enhance the research and improve its quality.
Publication also allows other researchers to identify what other pilot and feasibility work is ongoing, facilitating collaboration between those with similar interests who may share a common goal.
Biomedical research is almost always person-focused; any sharing of good practice at an early stage can only be of benefit to those being studied.
What advances are happening in the field to facilitate the complete reporting of pilot and feasibility studies?
I am a member of a working group that is seeking to develop CONSORT extension guidelines for the reporting of pilot trials. Our aim is to have these guidelines completed this calendar year so that researchers can benefit from a clear structured checklist to ensure all the important information from a pilot trial is reported.
The key aspects the guidelines cover range from the wording in the title to the discussion of the findings in relation to the future definitive trial.
In the future, we hope to extend these guidelines more widely to cover feasibility and pilot studies, as many of the reporting issues are very similar. More information about this work can be found in my editorial.
… I am a member of a working group that is… seeking to develop CONSORT extension guidelines … to ensure all the important information from a pilot trial is reported…
What other issues surround pilot and feasibility study conduct or reporting?
When carrying out our work on the reporting guidelines we discovered that there is some controversy surrounding the definition of a feasibility study versus a pilot study. Most researchers have their own favorite terminology and there is strength of feeling and resistance to adopting different terminology. As the evidence-base for pilot and feasibility studies increases, it will be interesting to see how this debate progresses.
Another key issue is the setting of suitable aims and objectives. Pilot and feasibility study objectives differ to those for the definitive trial as they are based on the ‘feasibility’ of conducting a future trial or large scale study. For example, they assess which patient-centered outcome measures are best or they gather preliminary data for future sample size estimation.
In comparison, the main aim of the definitive trial will usually be to determine treatment effectiveness. The sample sizes of pilot or feasibility studies are not usually sufficient to test this, nor are they designed to do so – this is not the aim of pilot and feasibility studies.
How important is open access in your community?
Today we live in a global world where we want information at our fingertips ‘online’.
Much debate surrounds whether we ought to go for ‘gold’ or ‘green’ open access options. Pilot and Feasibility Studies, as well as other BioMed Central journals, operates under gold, where the author pays and access to the article is unrestricted.
Open access is very important in the academic research community, and universities do recognize this and are starting to make funds available to support researchers wanting to publish open access.
Having unrestricted access to online peer-reviewed articles not only benefits the established research community, but also opens up the latest research findings to researchers from developing countries, who previously have been financially restricted or excluded.