155 The contribution of regional protocols on practice variation in induction of labor from 14.3% to 41.1% (19). Because IOL is a major intervention during pregnancy with the potential for harm, it should only be performed on medical indication (20). In situations complicated by pre-eclampsia of diabetes mellitus, the benefits of IOL for mother and child outweigh the harms. However, IOL is also associated with less favourable outcomes such as the risk of uterine hyperstimulation and rupture, fetal distress, and more unplanned caesarean sections (20). This study focused on variation in regional protocols as one of the factors that may contribute to practice variation at the meso-level of the sociological model of practice variation. The purpose of this study was to analyze variation between regional protocols, and variation between regional protocols and national guidelines regarding recommendations for IOL. Additionally, we explored the extent to which national guidelines were used in regional protocols and whether this was related to the quality of the national guidelines. Methods 2.1 Design We conducted a critical document analysis to gain insight into and understanding of the regional protocols and national guidelines. We used the READ approach as a systematic qualitative description approach (21). The READ (Ready materials, Extract data, Analyze data, Distil) approach provides a step-by-step guide to document analysis in health policy research, extracting insight from documents, while ensuring rigor in the analysis. The READ approach can be adapted to different purposes and types of research and is useful for understanding policy content at regional, national, or global level. 2.2 Setting This study was part of the larger VALID study, which describes practice variation in IOL between MCNs in the Netherlands and explores the different mechanisms that influence the decision-making process about IOL. The aim was to select a total of six MCNs for the VALID study, three MCNs with a high percentage of IOL and three MCNs with a low percentage of IOL In the Netherlands, the Perined database includes data from medical records of almost all births (19). For the VALID-study, the records with a relatively low risk for severe pregnancy complications in the years 2016-2018 were selected. IOL rates in these groups were calculated per MCN with case-mix correction for available socio-demographic factors. The six MCNs with the highest percentage of IOL and the six VSVs with the lowest percentage of IOL were approached for participation. In both groups, at least three MCNs were willing to participate, with the final selection taking into account geographical distribution. Both groups also included an MCN situated around an academic hospital. 7
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