Existing data sources for clinical epidemiology: The pharmo database network

The PHARMO Database Network provides a unique opportunity to gain insight in the complete patient journey and healthcare in the Netherlands. The PHARMO Database Network is a population-based network of electronic healthcare databases and combines anonymous data from different primary and secondary healthcare settings in the Netherlands. Healthcare settings include general practitioners, out-patient and in-patient pharmacies, hospitals and clinical laboratories. Furthermore, databases are linked with external registries suc

Linking databases on perinatal health: a review of the literature and current practices in Europe

BACKGROUND: International comparisons of perinatal health indicators are complicated by the heterogeneity of data sources on pregnancy, maternal and neonatal outcomes. Record linkage can extend the range of data items available and thus can improve the validity and quality of routine data. We sought to assess the extent to which data are linked routinely for perinatal health research and reporting. METHODS: We conducted a systematic review of the literature by searching PubMed for perinatal health studies from 2001 to 2011 based on linkage of routine data (data collected continuously at various time intervals). We also surveyed European health monitoring professionals about use of linkage for national perinatal health surveillance. RESULTS: 516 studies fit our inclusion criteria. Denmark, Finland, Norway and Sweden, the US and the UK contributed 76% of the publications; a further 29 countries contributed at least one publication. Most studies linked vital statistics, hospital records, medical birth registries and cohort data. Other sources were specific registers for: cancer (70), congenital anomalies (56), ART (19), census (19), health professionals (37), insurance (22) prescription (31), and level of education (18). Eighteen of 29 countries (62%) reported linking data for routine perinatal health monitoring. CONCLUSION: Research using linkage is concentrated in a few countries and is not widely practiced in Europe. Broader adoption of data linkage could yield substantial gains for perinatal health research and surveillance

Record linkage of population-based cohort data from minors with national register data : A scoping review and comparative legal analysis of four European countries

Funding Information: We would like to acknowledge Evert-Ben van Veen from the MLC Foundation, Dagelijkse Groenmarkt 2, 2513 AL Den Haag, the Netherlands. The results on the country-specific text on the Netherlands was based on his contribution. Publisher Copyright: © 2021 Doetsch JN et al.Background: The GDPR was implemented to build an overarching framework for personal data protection across the EU/EEA. Linkage of data directly collected from cohort participants, potentially serving as a prominent tool for health research, must respect data protection rules and privacy rights. Our objective was to investigate law possibilities of linking cohort data of minors with routinely collected education and health data comparing EU/EEA member states. Methods: A legal comparative analysis and scoping review was conducted of openly accessible published laws and regulations in EUR-Lex and national law databases on GDPR's implementation in Portugal, Finland, Norway, and the Netherlands and its connected national regulations purposing record linkage for health research that have been implemented up until April 30, 2021. Results: The GDPR does not ensure total uniformity in data protection legislation across member states offering flexibility for national legislation. Exceptions to process personal data, e.g., public interest and scientific research, must be laid down in EU/EEA or national law. Differences in national interpretation caused obstacles in cross-national research and record linkage: Portugal requires written consent and ethical approval; Finland allows linkage mostly without consent through the national Social and Health Data Permit Authority; Norway when based on regional ethics committee's approval and adequate information technology safeguarding confidentiality; the Netherlands mainly bases linkage on the opt-out system and Data Protection Impact Assessment. Conclusions: Though the GDPR is the most important legal framework, national legislation execution matters most when linking cohort data with routinely collected health and education data. As national interpretation varies, legal intervention balancing individual right to informational self-determination and public good is gravely needed for health research. More harmonization across EU/EEA could be helpful but should not be detrimental in those member states which already opened a leeway for registries and research for the public good without explicit consent.Peer reviewe

Evaluation of primary care midwifery in the Netherlands: design and rationale of a dynamic cohort study (DELIVER)

<p>Abstract</p> <p>Background</p> <p>In the Netherlands, midwives are autonomous medical practitioners and 78% of pregnant women start their maternity care with a primary care midwife. Scientific research to support evidence-based practice in primary care midwifery in the Netherlands has been sparse. This paper describes the research design and methodology of the multicenter multidisciplinary prospective DELIVER study which is the first large-scale study evaluating the quality and provision of primary midwifery care.</p> <p>Methods/Design</p> <p>Between September 2009 and April 2011, data were collected from clients and their partners, midwives and other healthcare professionals across the Netherlands. Clients from twenty midwifery practices received up to three questionnaires to assess the expectations and experiences of clients (e.g. quality of care, prenatal screening, emotions, health, and lifestyle). These client data were linked to data from the Netherlands Perinatal Register and electronic client records kept by midwives. Midwives and practice assistants from the twenty participating practices recorded work-related activities in a diary for one week, to assess workload. Besides, the midwives were asked to complete a questionnaire, to gain insight into collaboration of midwives with other care providers, their tasks and attitude towards their job, and the quality of the care they provide. Another questionnaire was sent to all Dutch midwifery practices which reveals information regarding the organisation of midwifery practices, provision of preconception care, collaboration with other care providers, and provision of care to ethnic minorities. Data at client, midwife and practice level can be linked. Additionally, partners of pregnant women and other care providers were asked about their expectations and experiences regarding the care delivered by midwives and in six practices client consults were videotaped to objectively assess daily practice.</p> <p>Discussion</p> <p>In total, 7685 clients completed at least one questionnaire, 136 midwives and assistants completed a diary with work-related activities (response 100%), 99 midwives completed a questionnaire (92%), and 319 practices across the country completed a questionnaire (61%), 30 partners of clients participated in focus groups, 21 other care providers were interviewed and 305 consults at six midwifery practices were videotaped.</p> <p>The multicenter DELIVER study provides an extensive database with national representative data on the quality of primary care midwifery in the Netherlands. This study will support evidence-based practice in primary care midwifery in the Netherlands and contribute to a better understanding of the maternity care system.</p

Data quality and methodology in studies on maternal medication use in relation to congenital anomalies

In Nederland wordt ongeveer 1 op de 30 kinderen geboren met een aangeboren afwijking, zoals een open ruggetje (spina bifida), gespleten lip en/of gehemelte (schisis), of een gaatje in het hart (septum defect). Eén van de risicofactoren voor het ontstaan van een aangeboren afwijking is medicijngebruik door de moeder tijdens de zwangerschap. Veel vrouwen gebruiken medicijnen gedurende hun zwangerschap, terwijl van verschillende geneesmiddelen niet helemaal duidelijk is of deze mogelijk schadelijk kunnen zijn voor het ongeboren kind. Om onderzoek te doen naar mogelijke relaties tussen medicijngebruik van de moeder tijdens de zwangerschap en aangeboren afwijkingen, zijn speciale databases nodig met zo volledig mogelijke informatie over aangeboren afwijkingen, zoals de EUROCAT database. EUROCAT is een Europees netwerk van registraties van kinderen met aangeboren afwijkingen. Daarnaast is goede informatie over medicijngebruik tijdens de zwangerschap nodig. Uit dit promotieonderzoek is gebleken dat het koppelen van databases met gegevens over voorgeschreven medicijnen aan de EUROCAT-data van grote toegevoegde waarde is, omdat de EUROCAT-data voor wat betreft bepaalde medicatie, zoals antidepressiva, anti-astmamedicatie, antibiotica en bepaalde ovulatie-stimulerende middelen niet compleet zijn. Omdat het onduidelijk is of de medicijnen die tijdens de zwangerschap zijn voorgeschreven ook daadwerkelijk zijn gebruikt, hebben we ook hier onderzoek naar verricht. Voor de meeste geneesmiddelgroepen bleek dit wel het geval, waardoor we kunnen stellen dat voorschrijfgegevens gebruikt kunnen worden als een betrouwbare bron voor het onderzoek naar medicijngebruik tijdens de zwangerschap. Voor het goed kunnen monitoren van medicijngebruik tijdens de zwangerschap in relatie tot aangeboren afwijkingen bij het kind, zijn grote databases nodig die alleen gerealiseerd kunnen worden door internationale samenwerking, zoals in het EUROmediCAT project.In the Netherlands one in 30 children is born with a congenital anomaly, like spina bifida, cleft or a heart defect. One of the risk factors for congenital anomalies is maternal medication taken during pregnancy; this is very common, despite uncertainties about the safety of many medicines. Special databases to record full information on congenital anomalies are needed to be able to investigate possible associations with maternal medication use during pregnancy. EUROCAT maintains one such database. EUROCAT is an European network of congenital anomalies registries. In addition, good information on maternal medication use during pregnancy is needed.This thesis shows that linking prescription databases to EUROCAT data supplements the data recorded on mother’s medication use, which is not always complete for specific medications like certain antidepressants, anti-asthmatics, antibacterials, and some ovulation stimulants. However, from prescription databases it is still unclear whether the prescribed medication was actually taken. We therefore studied the actual use of medicines during pregnancy. It seems that most medication is indeed taken, which means that data from prescription records can be used as a reliable source of data for research into medication use during pregnancy. Very large databases are needed for monitoring possible associations between maternal medication use in pregnancy and congenital anomalies and these can only be realised by international collaborations, as formed for the EUROmediCAT project, for example