Main findings
Performing case study research of a novel device on labour ward in an
emergency intrapartum setting is feasible and acceptable to those
involved. The case studies utilised participant observation as well as
in-depth interviews with operators, midwives and women to explore the
introduction of an innovative device in context and in detail.
Experiences and views of all stakeholders were easily obtained and we
were able to investigate these in detail. The use of multiple data
sources supported a comprehensive evaluation and triangulation of data
on the novel device intervention including device design, instructions
for use and clinical parameters for use. Operator interviews were found
to be of crucial importance when exploring optimum use of the Odon
Device and were obtained from 39/40 (97.5%) cases. Conducting case
studies in different contexts (such as different analgesia, different
presentations of babies, different operators) enabled commonalities and
disparities in technique to be highlighted and thoroughly investigated.
Furthermore, case studies enabling rapid understanding of the amendments
required to disseminate to the team such as applying the device during a
contraction. Principal technique adaptations were centred on device
application and deflation of the air cuff. Device modifications were
recommended for useability rather than to transform the functionality of
the device. Optimal parameters for device use were proposed and focussed
primarily on the station of the baby.
Case study methodology enabled real-time evaluation of device
introduction, including technique for device use and the operator
“learning curve”, the phrase that is commonly used to describe the
clinicians’ process of gaining knowledge and improved skills in
performing a procedure. Despite having no universal definition
“learning curve” is accepted to reflect the number of and/or time
taken to independently perform a procedure with a satisfactory outcome.
It is widely appreciated that there is a substantial operator learning
curve when introduced to a novel device; however, this curve can vary in
how steep it is. An operator’s background expertise or experience may
also affect the results of a medical device trial. Variety in operator
experience will invariably lead to different levels of performance when
using a novel device, with the success of novel device use potentially
disproportionally impacted by lack of experience. Most of the research
on operator learning curve for novel devices is published when the
technique is stable, not during Stage 2 trials where understanding of
technique may still be developing. Operators were initially trying to
use the Odon Device like other devices (forceps and ventouse) but
realised early on that they had to be open-minded to learning a
completely new technique (such as applying the device with a
contraction). Case study methodology encouraged operators to reflect,
critique and appraise their use of the device for each birth, resulting
in enhanced and enriched communication between operators regarding their
experiences through conversations and a dedicated operator messaging
group. In future, data from encrypted social media platforms could be
incorporated into the qualitative data for analysis.