July 15, 2020

Active Surveillance & Canadian multi-province Cohorts of Pregnant Women and Children

Query 19-03: Active Surveillance & Canadian multi-province Cohorts of Pregnant Women and Children.

This research is funded by the Drug Safety and Effectiveness Network (DSEN) and conducted by the following investigators: Anick Berard, Sasha Bernatsky, Cristiano Soares de Moura, Dan Chateau, Brandy Winquist, Bruce Carleton, Simon Vigod, Cindy-Lee Dennis, Padma Kaul, Sherif Eltonsy, Judith Maro.

Issue:

  • To date, the majority of studies on the risks and benefits of medication use during pregnancy include small sample sizes, lack of statistical power, or have sub-optimal study designs to investigate rare outcomes such as congenital malformations, low birth weight or prematurity.
  • To circumvent these limitations, in recent years, large national administrative databases or registries have been increasingly used in the field of perinatal pharmacoepidemiology, recognizing the importance of large size longitudinal pregnancy cohorts.

Study aim:

  • To develop a provincial mother-child longitudinal, population-based cohorts in Canada (QC, ON, MB, SK, AB, BC);
  • To develop standardized and harmonized tools (Common Data Models (CDM)/Definitions/Codes/Algorithms) to adequately and similarly identify pregnancy/child cohorts with longitudinal follow-up within 6 participating provinces using linkages between administrative and hospital databases based on the Quebec Pregnancy/Child Cohort (QPC), and the US Sentinel Program;
  • To put in place a common repository using the CIHR funded Maelstrom Database Research platform in order to share codes, algorithms, CDM, etc, and start downloading aggregate data (means, prevalences, risks) relevant to decision-makers such as the prevalence of medication use during pregnancy and childhood, the prevalence of major malformations, prematurity, low-birth-weight, etc., that will come directly from the 6 participating province databases;
  • To conduct a systematic review of active surveillance methodologies and perform pilot studies on active surveillance using the Canadian Healthcare system data and other types of data that may inform pharmacovigilance in Canada.

Study description:

  • We propose to bring together data from six provinces – Quebec (QC), Ontario (ON), Manitoba (MB), Saskatchewan (SK), Alberta (AB), and British Columbia (BC) – to address a critical public health issue facing Canada and the rest of the world: the impact of prescription drug use during pregnancy on long-term health outcomes in the mother and child.
  • The six provincial pregnancy-birth cohorts that we intend to align will be developed by linking several healthcare administrative databases available through the individual provinces’ ministries of health. Healthcare administrative databases have become a cornerstone in the process of assessing performance and providing feedback to improve the quality of healthcare delivery and outcomes at a population-level.
  • The single-payer integrated system of health care delivery in Canada has facilitated the linking of inpatient, outpatient (including emergency department (ED) visits), hospital, ambulatory care, pharmaceutical, immunization, and laboratory data in the six provinces. The volume of data generated by linking the health care databases to environment and census data has brought us into the wider realm of “big-data”.
  • During the current 12-month project, we intend to further develop standardized and harmonized algorithms and coding systems for the analysis of the pregnancy-birth cohort data across the six provinces. The resulting data infrastructure, the ‘Canadian Multi-Province Cohorts of Pregnant Women and Children’, can serve multiple functions and will result in specific tangible benefits for Canada, including:
    1. Finding cost-effective health strategies and policies improving the health of mothers, children, and the overall Canadian population;
    2. Providing a pharmacovigilance resource that can be used to rapidly answer queries from policymakers;
    3. Building capacity and training the next generation of Canadian researchers so that they can maintain their competitive advantage at the international level in the field of Medications and Pregnancy; and
    4. Developing a Canadian consortium of researchers, technicians, and knowledge users that can continue to take an active leadership role in building an international collaborative network. The expertise and access to big data necessary to build this proposed infrastructure are already present and in place in Canada.

Current status:

We have developed a website for the current study (motherchildcohort.ca). The methodology sharing platform has been developed and used by participating provinces/team members. The repository is underway but has slowed due to COVID-19.

For more information, contact: Autumn Neville, Research Coordinator. [email protected]a