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.