Stakeholder’s perspectives and experiences of patient and public involvement (PPI) in clinical trials in maternal and neonatal healthcare: protocol for a qualitative evidence synthesis

Background: Patient and public involvement (PPI) has the potential to improve relevance of trial outcomes participant recruitment within clinical trials. However, literature on PPI approaches, outcomes, attitudes towards in specific research areas is limited. We are interested know current approaches views maternal neonatal trials, from perspective experience involved stakeholders. Methods: A qualitative evidence synthesis (QES) stakeholders’ perspectives experiences will be conducted. Stakeholders include any individual or trials with area who expresses their PPI. The electronic bibliographic databases CINAHL, MEDLINE, PsycINFO, EMBASE, Web Science Maternity Infant Care (OVID) searched inception. Qualitative studies, mixed-methods studies where data can extracted independently, surveys open-ended questions, included. Aims: QES seeks explore stakeholders’, including contributors, participants guardians, researchers, trials. Discussion: THE provide an understanding how understood, operationalised experienced by stakeholders aim identifying good practice for improvement. PROSPERO registration: CRD42023383878 (2nd March 2023)