Pregnant and breastfeeding women are not usually including in clinical trials of medicines and vaccines. However, pregnant and breastfeeding women may decide with their doctor that they need to take a medicine or vaccine. When this happens, it can be captured in the woman’s medical record. Using data from medical records can help doctors and women to understand how safe a medicine or vaccine might be for pregnant and breastfeeding women.
The Innovative Medicines Initiative (IMI) Conception Consortium is a large group of public and private institutions across Europe, such as universities and pharmaceutical companies. IMI Conception will use anonymised healthcare data, meaning healthcare data that cannot be used to identify individual patients, to help understand how often certain medicines and vaccines are used by pregnant and breastfeeding women, and how safe those medicines and vaccines are for pregnant and breastfeeding women. For Clinical Practice Research Datalink (CPRD) to join this work, IMI Conception needs to know that CPRD has enough data that makes sense to study medicines and vaccines in pregnant and breastfeeding women. This study will measure how complete CPRD data are, such as how many pregnant women have a year of birth, and measure how much sense the data make, such as checking that a medicine prescription does not happen before a woman’s year of birth. This is important for IMI Conception to check across all the data used for their studies, so that researchers can be confident in the results of studies that use these data.
The Innovative Medicines Initiative (IMI) ConcePTION Consortium consists of public and private institutions across Europe. The IMI ConcePTION Consortium will use anonymised healthcare data to study medicine and vaccine utilisation in pregnant and breastfeeding women, and to provide insight on the safety of those medicines and vaccines in pregnant and breastfeeding women. For Clinical Practice Research Datalink (CPRD) to join this work, an Extract, Transfer, Load (ETL) has been designed to translate CPRD GOLD, the Pregnancy Register, and the Mother-Baby Link to the common data model (CDM) used by IMI ConcePTION. Data characterisation of CPRD in this CDM is required to ensure that minimum standards of completeness, correctness, logical relationships and integrity of data values within and between variables, and within and between tables, are met. This study will implement the ETL and run standard data characterisation checks, designed by IMI ConcePTION. Specifically, the data characterisation will assess: (i) completeness and correctness of the ETL for CPRD GOLD, (ii) logical relationship and integrity of data values within a variable or between two or more variables within and between tables, and records occurring outside of recorded person time (i.e. before birth, after death, or outside of recorded observation periods).
This feasibility study will use the Pregnancy Register to identify pregnant women, and the Mother-Baby Link to identify mothers and babies, and compare these CPRD linked data sets with the version of these data sets generated by the IMI ConcePTION Consortium ETL.
The outcomes to be measured will be the completeness and correctness of the ETL for CPRD GOLD (compared to the CPRD linked data sets of the Pregnancy Register and Mother-Baby Link), (ii) logical relationship and integrity of data values within a variable or between two or more variables within and between tables, and records occurring outside of recorded person time (ETL compared to CPRD Pregnancy Register and MBL).
Specifically, the following variables from CPRD GOLD, the Pregnancy Register, and the MBL will be used to compare CPRD data with the ETL version of these data tables:
Patient ID; mother patient ID; baby patient ID; month of birth; year of birth; date of death; gender; accept (CPRD quality standards); current registration date; transferred out date; practice up to standard date; last collection date; Clinical consultation ID; visit event dates; Clinical event dates; Clinical medcodes; Referral event dates; Referral medcodes; Therapy event dates; Therapy quantity; Therapy pack type; Therapy dosage ID; Therapy number of days; CPRD Product code; Product name; Product formulation; Product route; BNF code; Product drug substance; Product strength; Test event dates; Test medcodes; Test entity type; CPRD Entity data1 field; CPRD Entity data2 field; CPRD Entity data3 field; CPRD Entity data4 field; CPRD Entity data5 field; CPRD Entity data6 field; CPRD Entity data7 field; Test consultation ID; Additional Clinical Detail ID to link to Clinical table; Additional Clinical Details entity type; Vaccine event date; Immunisation components (immstype); Immunisation compound; Immunisation batch; Immunisation consultation ID; Pregnancy Register pregnancy ID; Pregnancy Register patient ID; Pregnancy Register Mblbabies; Pregnancy Register pregnancy start; Pregnancy Register start source; Pregnancy Register pregnancy end; Pregnancy Register end source; Pregnancy Register gestational days; Pregnancy Register maternal age; Pregnancy Register pregnancy outcome
Mary Betsey Georgiou - Chief Investigator - GSK
Mary Betsey Georgiou - Corresponding Applicant - GSK
John Logie - Collaborator - GlaxoSmithKline Research & Development Limited (UK)
CPRD GOLD Pregnancy Register;CPRD GOLD Mother-Baby Link