Patient and Public Involvement
In line with INVOLVE guidance, a Public Engagement Panel (PEP)
participated in the development of the original device and continued to
provide advice throughout the clinical research phase. The co-ordinator
of this group was a full member of the Trial Management Group that met
each month and provided ongoing liaison with the PEP. The PEP provided
initial input into the consent and recruitment process, met the PI and
research midwives 6-monthly during the study to provide ongoing advice
and feedback, and again at the end to discuss conclusions and overall
assessment of the outcomes. A public meeting attended by hospital staff,
recruiters, researchers and patient participants was held in January
2020 to discuss the results and provide input into the final
conclusions.