Discussion
This pilot study addressed four main feasibility criteria prior
to undertaking a larger randomised controlled study: 1)
recruitment; 2) loss to follow-up; 3) fidelity; 4) interrater
reliability. Important lessons can be learned from undertaking
pilot studies, which may lead to an improvement in the
design and execution of a larger trial (Thabane et al, 2010).
This pilot study allowed the researchers to refine some of
our processes, including making modifications to the data
collection tool. Only minor changes to the data collection
tool were necessary during the conduct of the study. These
changes mainly involved refinement of the surgical technique
questions, but the design of the chart audit tool was also
adjusted to reduce confusion surrounding SSI indicators.
Summary of the enablers and barriers to recruitment, loss to
follow-up and fidelity are presented in Table 2.
Recruitment
The recruitment process proved to be time-
consuming and subsequently expensive at
the chosen site. Over the nine months of the
study, the elective CS rate decreased by one
third, which impacted heavily on the number
of eligible women available. The environmental
aspects, such as the confined physical
workspace, and the existing processes created
barriers to accessing potential women. The
medical clinics were ‘themed’ to promote a more
streamlined service but, despite this, women
would be transferred in and out of clinics. This
prevented a more selective targeting of potential
participants. As others have noted, these issues
only became evident once recruitment strategies
were actually implemented (Jairath et al, 2000).
Uncovering organisational change issues, such
as the loss of the triage midwife role, using
feasibility criteria which may impact on the
progress of the study can only strengthen the
larger trial (van Teijlingen and Hundley, 2002).
Ongoing education seminars and product
training was provided to midwives, medical
staff and OR nurses at the start, and for the
duration of, the study, as staff regularly rotated
through the hospital. Thus, through this pilot,
the researchers identified the need for ongoing
training resources to be allocated for the
duration of the trial.