The Italian midwifery core outcome set (M-COS) for healthy childbearing women and newborns: Development and initial validation study

Objective: This study aimed to develop and validate a midwifery core outcome set (M-COS) for Italian settings based on a salutogenic framework of maternity care. Design: A multi-phase and multi-method study was performed. In phase one, we conducted a literature review to identify a preliminary set of outcomes sensitive to midwifery care. In phase two, the qualitative and quantitative content validity of the M-COS was tested. Finally, in the third phase, construct validity was explored through a cross-sectional study to assess the psychometric properties of the M-COS through exploratory and confirmative factor analysis. This study was conducted from December 2019 to April 2020 in Italy. Participants: Three main groups of experts/midwives were involved. Group One (n = 10) was involved in the content validity phase, while the other two groups (Group Two and Group Three) were involved in the construct validity phase (n = 300). Results: The M-COS includes six outcome domains and thirty-one core outcomes perceived as sensitive to midwifery care, namely: mortality and morbidity (n = 6 outcomes), childbirth (n = 3), postnatal period (n = 6), maternal health (n = 11), maternal-infant bonding (n = 3), and maternal self-care (n = 2). All domains showed good evidence of internal consistency. Conclusion: The Italian M-COS is a novel tool that will facilitate the consistent measurement of core outcomes sensitive to midwifery care from the antenatal to the postnatal period in Italian settings. This initial work will be followed by further studies, including validation by service users. Implications for practice: The use of the M-COS in clinical practice would facilitate evidence-based data collection and thus contribute to promoting high-quality maternity care.