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.