Strengths and limitations
This research aimed to create a holistic approach to understanding optimum Odon Device use through adopting case study research. An AVB is a complex intervention and this makes studying the use of the device challenging. A complex intervention can be defined as having a number of interacting components which can act independently or interdependently to influence outcomes. Qualitative case study methodology uses multiple data sources from multiple cases to study phenomena: enabling the researcher to assess differences and similarities through the methodology of systematic cross comparison. Recently, qualitative case study methodology has been used to explore technique in surgical procedures however, there are no published examples of case study methodology being used to investigate any novel devices. Triangulation of case study findings from observations and interviews sped up the process of device investigation by being able to promptly confirm modifications for optimum device use. Operator interviews were particularly beneficial in optimising techniques for device use. Combined with rapid analysis, findings could be disseminated rapidly to operators. By using this methodology and incorporating data from all stakeholders and observations we were able to gain a balanced and comprehensive assessment of the use of the device. Participant observation was selected, enabling the researcher to play an active role in the setting if needed and become immersed in the environment. This allowed exploration of reality and contextual factors in real time. However, participant observation may be influenced by the interpretation of the individual researcher. It could be argued that participant observation is actually good practice as reflects standard practice of team working and learning. Interviews with operators were undertaken for all but one case. These were of crucial importance in understanding optimal device use. Little new data transpired from observation and women’s interviews after eight cases, so data collection focused on operator interview going forward. The flexibility of case study methodology allowed data collection to respond to initial findings and to focus on the most informative mode of data collection.
Case studies within the ASSIST Study were finite. Observations were undertaken where possible, however due to the unpredictable nature of AVBs it was not possible to attend all assisted births. Indeed, none of the more complex attempted AVBs performed in the operating theatre were observed.