Understanding novel device introduction

: an exploratory study of the Odon Device for assisted vaginal birth with implications for trials, training and clinical practice

Abstract

One of the factors thought to be responsible for the lack of novel methods to assist vaginal birth is the challenge of introducing a novel device into clinical use, especially because it forms part of a complex healthcare intervention. This has implications for early phase research, where there are likely to be iterative changes to device technique, design and indications for use. This thesis explores how a novel device for assisted vaginal birth, the Odon Device, was introduced into clinical use, evaluated, and monitored. There are four components: i) a systematic review of the reporting standards of trials in assisted vaginal birth, ii) a mixed-methods study investigating a training programme for the Odon Device, iii) a feasibility study exploring the introduction of the Odon Device, and iv) exploratory work using case study methodology, involving observation and interviews, to investigate how novel device use can be optimised.
A systematic review identified 39 papers evaluating 80 device interventions and comparators, published between 1964 and 2020. Descriptions were varied and often poor, with limited information regarding standardisation or monitoring provided, perhaps due to the lack of device-specific reporting standards. The bespoke training programme for the Odon Device demonstrated feasibility and suggested that it was successful for both inexperienced and experienced operators. The findings of the third and fourth parts of the thesis established that the device can successfully assist vaginal birth, and further helped optimise device use through recommending iterations to device use technique, device design and indications for use.
Novel device development could be improved by adopting these research methods and by implementing a proposed device-specific framework for ensuring and establishing optimal use when undertaking research. It is now essential to assess this within other settings and with additional devices.

Date of Award	27 Sept 2022
Original language	English
Awarding Institution	University of Bristol
Supervisor	Natalie S Blencowe (Supervisor), Erik Lenguerrand (Supervisor) & Julia Wade (Supervisor)