Openheid over medische fouten: waar staan we?

•Recente, breed gedragen richtlijnen bepalen dat artsen en andere zorgverleners open en eerlijk behoren te zijn over incidenten, dat wil zeggen: medische fouten. •Deze norm wordt versterkt door uitspraken van het tuchtcollege en zal naar verwachting binnenkort ook wettelijk geregeld worden. •In de praktijk is er nog sprake van tal van persoonlijke en institutionele belemmeringen bij het communiceren over incidenten. •De elders ontwikkelde open benadering (‘open disclosure’-benadering) kan ook in Nederland behulpzaam zijn bij het wegnemen van die belemmeringen. (aut. ref.

The impact of ex-post legislative evaluations in healthcare:A mixed methods realist evaluation study protocol for conducting case studies

Background:Recent studies on the impact of ex-post legislative evaluations show that there are different types of impact and different factors that can influence it. These include the context of a legislative evaluation, research quality, and interactions between researchers and other actors within the evaluation process. However, thorough empirical research in this area is lacking. This warrants empirical research into the factors that influence the impact of ex-post legislative evaluations, so these insights can be used to increase the likelihood of ex-post legislative evaluations having an impact.Methods and analysis:In this protocol, we report on the realist evaluation methodology that will be used to evaluate the impact of three ex-post legislative evaluations in the Dutch healthcare sector. The mixed methods realist evaluation approach will facilitate this theory-driven, qualitative research. The study will consist of the following three steps: (1) Initial programme theory development, (2) theory validation, and (3) theory refinement. Knowledge from two scoping reviews conducted previously, and two subsequent expert meetings will form the basis for developing the initial programme theory. During this study, three case studies will be conducted, in which three individual ex-post legislative evaluations will be examined. Specific methods for data collection will include: documentary review, observation, structured questionnaires and focus group discussions with purposefully identified key stakeholders. Using the framework approach, the data will be analysed thematically in a within-case analysis followed by across-case analysis. Discussion:This protocol provides insight into how the study will be conducted. As this study uses multiple qualitative research methods to answer one question, this protocol supports refining data collection procedures. Careful consideration of the approach beforehand can minimise pitfalls, reduce publication bias and improve reproducibility. The protocol therefore specifies how the research question will be answered in detail, and this provides solid guidance for the research process