53 Clinical outcomes of aCTG in primary midwife-led care Analyses We created an overview of cases of perinatal death or severe perinatal morbidity during the indicated time period in the three regions. All cases were assessed by an expert team consisting of a midwife with an educational background in aCTG, a hospital-based midwife, and an obstetrician with experience in perinatal auditing and assessing incidents of sub-standard care. All three had expertise in assessing aCTGs and were not involved in the innovation project. A standardised procedure with a structured assessment was used to assess each potential SAE. The team was informed about the aCTG setting, procedure, and regional quality protocol regarding aCTG in primary care. For each case, the assessment consisted of three phases according to the ‘Eindhoven classification model-Prisma method’ and the KNOVguideline ‘Dealing with calamities in midwifery practices’ [28,29]. Assessment Phase 1: determine SAEs caused by clinical management in MLC. The expert team screened the records in the first assessment phase using 18 explicit screening criteria indicating potential SAEs. The records that met the screening criteria were reviewed and discussed to reach consensus on whether an SAE was related to clinical management in MLC. This decision was based on three criteria: 1) an unintended or unexpected event involving serious physical injury for the neonate, 2) the event resulted in temporary or most likely permanent disability, death, or NICU admission, and 3) the event was caused by clinical management of the care professional [30]. The degree to which the potential SAE caused by clinical management was measured using a 6-point scale (one=not caused by clinical management, and six=clearly caused by clinical management). As in other studies, a score of one to three indicated that the case was not an SAE caused by clinical management in MLC, and a score of four or higher indicated an SAE caused by clinical management in MLC [31]. Assessment Phase 2: classifying the causes of SAEs. In the second assessment phase, each SAE caused by clinical management was assessed by each expert independently using an assessment form to determine how the SAE could have happened and what might have caused it. SAEs often arise from multiple causal factors, such as human, organisational, technical, and patient-related factors. The experts selected all factors contributing to the SAE (Fig. 2). A plenary discussion to reach consensus followed each expert’s independent assessment. If consensus could not be reached, a majority decision was used. Assessment Phase 3: Classification of avoidability and prevention strategies. In the third assessment phase, the expert team assessed whether the SAEs were avoidable and, if so, potential prevention strategies were selected. Avoidability was defined as care below the professional standard and expected performance of professionals and systems. Avoidability was classified using a 6-point scale (one=not avoidable 3
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