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The Baby Hearts Study - a case-control methodology with data linkage to evaluate risk and protective factors for
N McCullough1, H Dolk1, M Loane1
1Institute of Nursing and Health Research, Ulster University, Newtownabbey, UK.
Insights
The Baby Hearts study used a hybrid data collection method to study congenital heart disease (CHD) risk factors in pregnant women. Findings suggest this approach effectively reduces bias and is replicable for future etiological research.
Area of Science:
- Epidemiology
- Public Health
- Reproductive Health
Background:
- The Baby Hearts study investigated risk and protective factors for congenital heart disease (CHD).
- It also examined health behaviors of pregnant women in Northern Ireland.
Purpose of the Study:
- To describe and evaluate a population-based case-control design.
- To enhance the design with administrative health data linkage.
Main Methods:
- Recruited 286 mothers of babies with CHD (cases) and 966 mothers of babies without CHD (controls).
- Employed hybrid data collection: iPad/postal questionnaires and linkage to maternity/prescription records.
- Achieved low refusal rates (8%) and high consent for data linkage (97%).
Main Results:
- Recruitment rates were 61% for cases and 68% for controls, representative of the population without selection bias.
- Significant discordance noted between self-report and records for first-trimester medications, but no substantial recall bias.
- Cases showed significantly lower concordance than controls for folic acid supplementation self-report versus maternity records.
Conclusions:
- Hybrid data collection methods are effective for etiological studies, reducing burden and addressing recall bias.
- The Baby Hearts study protocol is suitable for replication in other populations with local modifications.
Introduction:
The Baby Hearts study aimed to investigate risk and protective factors for congenital heart disease (CHD), and to investigate the health behaviours of a representative sample of pregnant women in Northern Ireland.
Objectives:
We describe and evaluate the population-based case-control design enhanced with data linkage to administrative health data.
Methods:
Cases (mothers of babies with CHD, n=286) were recruited following diagnosis prenatally or postnatally. Controls (mothers of babies without CHD, n=966) were recruited at 18-22 weeks gestation, from all women attending each maternity unit during a designated month. Hybrid data collection methods were used, including a self-administered iPad/postal questionnaire, and linkage to maternity and prescription records.
Results:
Refusal rates were low (8%). iPad questionnaire completion at clinic or home visit had high acceptability whereas postal questionnaires were poorly returned leading to a further 9-10% loss of eligible cases/controls. In total, 61% of eligible cases and 68% of eligible controls were recruited, closely representative of the Northern Ireland population, with no evidence of selection bias. Of those recruited, 97% gave consent for linkage to medical records. Thirty-three percent of women had an unplanned pregnancy and 76% suspected they were pregnant by 5 weeks gestation, with no significant differences between cases and controls. There was considerable discordance between self-report, maternity and prescription records regarding medications obtained/taken in the first trimester, but no evidence of differences between cases and controls that would indicate substantial recall bias. Although there was high concordance between self-report and maternity records regarding folic acid supplementation, cases had significantly lower concordance than controls.
Conclusions:
Our results suggest hybrid data collection approaches are a useful way forward for aetiological studies to reduce responder burden and address and estimate recall bias, and that the Baby Hearts study protocol is suitable for replication in other populations, modified to the local context.
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