158 Chapter 7 2.6 Ethics According to the ‘Act governing research involving human subjects’ in The Netherlands (WMO), formal ethical approval by a research ethics committee is only required for medical research where participants are subject to interventions or procedures, or are required to follow specific, research related rules of behavior (23). Because this research is a document analysis, none of these apply. As the focus of the study was on regional protocols and national guidelines, there was no need for anonymization of documents and no written consent was required. Results 3.1 Quality assessment national guidelines In the Netherlands, a standardized method for developing multidisciplinary national guidelines was introduced in 2012. Emphasis was put on an extensive literature review and reporting all individuals and stakeholders involved in the development procedure (12). The AGREE II domain scores of the analyzed guidelines reflected this process of standardization: the newest guideline (late term pregnancy; 2021) showed the highest scores and the eldest guideline (shoulder dystocia; 2008) had the lowest scores (Table 2). The second newest guideline ‘Elective induction of labor’ (2020) had a remarkably low score on ‘Stakeholder involvement’ (domain 2). The development process of this guideline was monodisciplinary, three other disciplines were only involved in the external review and authorization of the final version. Table 2. Quality assessment of four national guidelines based on the AGREE II instrument Guideline (year of publication) D1 D2 D3 D4 D5 D6 Quality score (0-7) Use Shoulder dystocia (2008) 7.4% 11.1% 23.6% 57.4% 5.6% 0.0% 2.33 No Reduced fetal movements (2013) 96.3% 64.8% 41.0% 81.5% 30.6% 0.0% 4.57 Yes Elective induction of labor (2020) 68.5% 25.9% 66.0% 85.2% 33.3% 44.4% 3.67 No Late term pregnancy (≥41 weeks pregnancy) (2021) 61.1% 66.7% 80.6% 94.4% 33.3% 100% 5.33 Yes Based on domain scores: D1 = Domain 1: Scope and purpose D2 = Domain 2: Stakeholder involvement D3 = Domain 3: Rigor of development D4 = Domain 4: Clarity of presentation D5 = Domain 5: Applicability D6 = Domain 6: Editorial independence Overall items: Quality score = numerical score of the guideline rated by the reviewing authors Use = verdict of the reviewing authors if they recognize the guideline as appropriate for use in clinical practice
RkJQdWJsaXNoZXIy MTk4NDMw