The Clinical Practice Research Datalink for Drug Safety in Pregnancy Research: an Overview

Charlton, Rachel; Snowball, Julia; Sammon, Cormac; Vries, Corinne De

doi:10.2515/therapie/2014007

Cited by 14 publications

(17 citation statements)

References 28 publications

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“…An inventory was completed for a sample of European databases that were contributing to the EUROmediCAT study [14], a Seventh Framework Programme study funded by the European Union that aimed to make more systematic use of electronic healthcare databases in combination with EUROCAT [15] congenital anomaly data. The databases covered Denmark [16][17][18], the Northern Netherlands [19,20], Norway [21][22][23], two regions of Italy (Tuscany [24,25] and Emilia Romagna [26]), Wales [27,28] and the Clinical Practice Research Datalink (CPRD) [29,30] capturing a sample of the rest of the UK. A summary of the databases can be found in Table 1 and has been reported elsewhere [14].…”

Section: Methodsmentioning

confidence: 99%

The limitations of some European healthcare databases for monitoring the effectiveness of pregnancy prevention programmes as risk minimisation measures

Charlton

Bettoli

Bos

et al. 2017

Eur J Clin Pharmacol

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Section: Methodsmentioning

confidence: 99%

The limitations of some European healthcare databases for monitoring the effectiveness of pregnancy prevention programmes as risk minimisation measures

Charlton

Bettoli

Bos

et al. 2017

Eur J Clin Pharmacol

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“…The start date of each pregnancy was estimated using an algorithm that incorporated information from all pregnancy-related codes in the woman’s record [9]; where insufficient information was available (18.8% of pregnancies) a default duration of 280 days was assigned. The medical records of the mothers were linked to those of the child using an algorithm described previously [10]. Linked mother–child pairs were included if the child was still registered in the CPRD at age 6 years and 3 months; this cut-off was chosen as most children in the prospective study were assessed shortly after their sixth birthday.…”

Section: Methodsmentioning

confidence: 99%

Sensitivity of the UK Clinical Practice Research Datalink to Detect Neurodevelopmental Effects of Medicine Exposure in Utero: Comparative Analysis of an Antiepileptic Drug-Exposed Cohort

et al. 2017

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IntroductionElectronic healthcare data have several advantages over prospective observational studies, but the sensitivity of data on neurodevelopmental outcomes and its comparability with data generated through other methodologies is unknown.ObjectivesThe objectives of this study were to determine whether data from the UK Clinical Practice Research Datalink (CPRD) produces similar risk estimates to a prospective cohort study in relation to the risk of neurodevelopmental disorders (NDDs) following prenatal antiepileptic drug (AED) exposure.MethodsA cohort of mother–child pairs of women with epilepsy (WWE) was identified in the CPRD and matched to a cohort without epilepsy. The study period ran from 1 January 2000 to 31 March 2007 and children were required to be in the CPRD at age 6 years. AED exposure during pregnancy was determined from prescription data and children with an NDD diagnosis by 6 years were identified from Read clinical codes. The prevalence and risk of NDDs was calculated for mother–child pairs in WWE stratified by AED regimen and for those without epilepsy. Comparisons were made with the results of the prospective Liverpool and Manchester Neurodevelopment Group study which completed assessment on 201 WWE and 214 without epilepsy at age 6 years.ResultsIn the CPRD, 1018 mother–child pairs to WWE and 6048 to women without epilepsy were identified. The CPRD identified a lower prevalence of NDDs than the prospective study. In both studies, NDDs were more frequently reported in children of WWE than women without epilepsy, although the CPRD risk estimate was lower (2.16 vs. 0.96%, p < 0.001 and 7.46 vs. 1.87%, p = 0.0128). NDD prevalence differed across AED regimens but the CPRD data did not replicate the significantly higher risk of NDDs following in utero monotherapy valproate exposure (adjusted odds ratio [ORadj] 2.02, 95% confidence interval [CI] 0.52–7.86) observed in the prospective study (ORadj 6.05, 95% CI 1.65–24.53).ConclusionIt was possible to identify NDDs in the CPRD; however, the CPRD appears to under-record these outcomes. Larger studies are required to investigate further.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-017-0506-5) contains supplementary material, which is available to authorized users.

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“…Few studies, however, distinguishing between over-the-counter (OTC) and prescription medicines and report how different conditions in pregnancy are being treated. Currently, the majority of UK research focuses on the use of electronic database to characterise utilisation patterns or to study medication safety in pregnancy in a way that does not explore perceptions of pregnant women regarding taking medication [ 8 – 10 ].…”

Section: Introductionmentioning

confidence: 99%

Women’s beliefs about medication use during their pregnancy: a UK perspective

2016

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Background Previous research has examined the number and extent of medicines taking in pregnant women but not their beliefs and risk perception surrounding their use. Objective To describe beliefs and risk perception associated with medicines use for the treatment of common acute conditions among UK women and explore whether this is related to actual medicines use. Settings Cross-sectional, web-based study in the UK. Methods Pregnant women and mothers within 1 year of giving birth were invited to participate in an online cross-sectional questionnaire-based study via a pregnancy website in the UK. Anonymous data were collected from women regarding their use of medicines (both over-the-counter and prescribed) and their beliefs regarding medicines use during pregnancy. Main outcome measures Pregnant women’s beliefs about medicines and their relation to pharmacological treatment of acute conditions in pregnancy. Results Pharmacological treatment of conditions in pregnancy ranged from 65.4 % for urinary tract infections (UTIs) to 1.1 % for sleeping problems. Almost three out of ten women avoided using some medications during pregnancy. For heartburn and UTIs, women who did not treat the condition viewed medicines in general as being overused, more harmful and less beneficial, than those who treated the condition. In general, UK pregnant women perceived medicines to be beneficial and slightly overused. Conclusions Women’s beliefs about medications impact on treatment of specific conditions in pregnancy such as heartburn and UTIs. Healthcare professionals should explore patient’s beliefs regarding medication at the first maternity care visit to promote appropriate medication use in pregnancy.Electronic supplementary materialThe online version of this article (doi:10.1007/s11096-016-0322-5) contains supplementary material, which is available to authorized users.

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The Clinical Practice Research Datalink for Drug Safety in Pregnancy Research: an Overview

Cited by 14 publications

References 28 publications

The limitations of some European healthcare databases for monitoring the effectiveness of pregnancy prevention programmes as risk minimisation measures

The limitations of some European healthcare databases for monitoring the effectiveness of pregnancy prevention programmes as risk minimisation measures

Sensitivity of the UK Clinical Practice Research Datalink to Detect Neurodevelopmental Effects of Medicine Exposure in Utero: Comparative Analysis of an Antiepileptic Drug-Exposed Cohort

Women’s beliefs about medication use during their pregnancy: a UK perspective

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