199 General Discussion with serious methodological challenges; the conditions in this type of study are far less controlled and nonrandomized, weakening internal validity and making it easy for confounding to occur. Evidence-based maternity care pays attention to the interventions that have been studied in RCTs.44 Other potentially more useful interventions that have not been examined by RCTs tend to be ignored. However, some issues cannot be studied by RCTs. RCTs are perfectly suited to evaluate the (average) relative effects of alternative forms of care for both simple and complicated problems, where the form of care used is the principal cause of the outcome found.44 They are less suitable and often misleading, for complex problems, where the outcomes depend more on the web of interactions between the care, the individuals concerned, and the context in which they occur. In maternity care, there are many examples with a direct, linear relationship between what is done and what are the results: e.g., corticosteroids for lung maturation with preterm birth, and magnesium sulfate for eclampsia. But when a problem is complex rather than just complicated, one can never be entirely sure of what will happen.44 An example of a complex problem is the evaluation of policy changes and their impact on health outcomes, as well as predictions on expected costs and resource use.45 In such cases, RCTs may not always be suitable, and their findings may not always be generalizable beyond the sample. Furthermore, in RCTs, bias can arise in the choice of outcomes to be studied. If an outcome is too rare, a statistically significant difference may not be found. This is also the case for aCTG, where the primary outcome (composite severe neonatal outcome) is too rare for RCTs to be feasible (Chapter 3). For this reason, observational data can be of considerable value in research. Observational evidence also has other strengths, such as the ability to study a whole population, whereas in RCTs, many women do not participate, resulting in a non-representative group. Furthermore, the use of existing and readily available observational data is inherently cost- and time-saving as the data have already been collected in the course of daily work, and re-use could reduce the administrative burden on providers by avoiding duplication of effort. This is in line with the principles for FAIR data (Findable, Accessible, Interoperable, Reusable).46 Reflexivity During the study, we considered how the attitude of the researchers might affect the research. The researchers each had their own social position, experiences, and beliefs. The author of this dissertation also works as a primary care midwife in a community practice. In this role, she performs aCTG assessments in practice. She was involved in setting up the MLC-CTG pilot project in the Zwolle region. This may have affected her attitude towards healthcare professionals’ considerations and opinions regarding MLC-aCTG. Authors with working experience in both community and hospital, as well as ambivalent attitudes towards the research topic, were involved in this dissertation in order to maintain objectivity and to consider all perspectives. Furthermore, the 7
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