Abstract
BackgroundLinking population health data to pathology data is a new approach for the evaluation of predictive tests that is potentially more efficient, feasible and efficacious than current methods. Studies evaluating the use of first trimester maternal serum levels as predictors of complications in pregnancy have mostly relied on resource intensive methods such as prospective data collection or retrospective chart review. The aim of this pilot study is to demonstrate that record-linkage between a pathology database and routinely collected population health data sets provides follow-up on patient outcomes that is as effective as more traditional and resource-intensive methods. As a specific example, we evaluate maternal serum levels of PAPP-A and free β-hCG as predictors of adverse pregnancy outcomes, and compare our results with those of prospective studies.MethodsMaternal serum levels of PAPP-A and free β-hCG for 1882 women randomly selected from a pathology database in New South Wales (NSW) were linked to routinely collected birth and hospital databases. Crude relative risks were calculated to investigate the association between low levels (multiples of the median ≤ 5th percentile) of PAPP-A or free β-hCG and the outcomes of preterm delivery (<37 weeks), small for gestational age (<10th percentile), fetal loss and stillbirth.ResultsUsing only full name, sex and date of birth for record linkage, pregnancy outcomes were available for 1681 (89.3%) of women included in the study. Low levels of PAPP-A had a stronger association with adverse pregnancy outcomes than a low level of free β-hCG which is consistent with results in published studies. The relative risk of having a preterm birth with a low maternal serum PAPP-A level was 3.44 (95% CI 1.96–6.10) and a low free β-hCG level was 1.31 (95% CI 0.55–6.16).ConclusionThis study provides data to support the use of record linkage for outcome ascertainment in studies evaluating predictive tests. Linkage proportions are likely to increase if more personal identifiers are available. This method of follow-up is a cost-efficient technique and can now be applied to a larger cohort of women.
Highlights
Linking population health data to pathology data is a new approach for the evaluation of predictive tests that is potentially more efficient, feasible and efficacious than current methods
A further 16 twin pregnancies, 11 medical terminations less than 20 weeks gestation and 4 infants diagnosed with aneuploidies were excluded, so that 1650 pregnancies were included in the analysis
There was no evidence that the unlinked pregnancies were different in regards to their plasma protein-A (PAPP-A) and free β-hCG results
Summary
Linking population health data to pathology data is a new approach for the evaluation of predictive tests that is potentially more efficient, feasible and efficacious than current methods. Studies evaluating the use of first trimester maternal serum levels as predictors of complications in pregnancy have mostly relied on resource intensive methods such as prospective data collection or retrospective chart review. The aim of this pilot study is to demonstrate that record-linkage between a pathology database and routinely collected population health data sets provides follow-up on patient outcomes that is as effective as more traditional and resourceintensive methods. Linkage of population health data to pathology data is a new approach for evaluating predictive tests that is potentially more efficient and efficacious than current methods. Successful linkage of pathology databases with those that routinely report health outcomes could provide a powerful and important tool for the evaluation of the clinical usefulness of a range of newly discovered biomarkers
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