Patient safety in midwifery care for low-risk women: instrument development.

INTRODUCTION: Few studies have examined the safety of midwife-led care for low-risk childbearing women. While most women have a low-risk profile at the start of pregnancy, validated measures to detect patient safety risks for this population are needed. The increased interest of midwife-led care for childbearing women to substitute for other models of care requires careful evaluation of safety aspects. In this study, we developed and tested an instrument for safety assessment of midwifery care. METHODS: A structured approach was followed for instrument development. First, we reviewed the literature on patient safety in general and obstetric and midwifery care in particular. We identified 5 domains of patient risk: organization, communication, patient-related risk factors, clinical management, and outcomes. We then developed a prototype to assess patient records and, in an iterative process, reviewed the prototype with the help of a review team of midwives and safety experts. The instrument was pilot tested for content validity, reliability, and feasibility. RESULTS: Trained reviewers with clinical midwifery expertise applied the instrument. We were able to reduce the original 100-item screening instrument to 32 items and applied the instrument to patient records in a reliable manner. With regard to the validity of the instrument, review of the literature and the validation procedure produced good content validity. DISCUSSION: A valid and feasible instrument to assess patient safety in low-risk childbearing women is now available and can be used for quantitative analyses of patient records and to identify unsafe situations. Identification and analysis of patient safety incidents required clinical judgment and consultation with the panel of safety experts. The instrument allows us to draw conclusions about safety and to recommend steps for specific, domain-based improvements. Studies on the use of the instrument for improving patient safety are recommended