Imperial College London
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Professor Christoph Lees, MD FRCOG

Faculty of Medicine, Department of Metabolism, Digestion and Reproduction

Professor of Obstetrics
 
 
 
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Contact

 

+44 (0)20 7594 5770c.lees

 
 
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Assistant

 

Ms Hazel Blackman +44 (0)20 7594 2104

 
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Location

 

Queen Charlottes and Chelsea HospitalHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Relph:2021:10.1186/s13063-021-05141-8,
author = {Relph, S and Elstad, M and Coker, B and Vieira, MC and Moitt, N and Gutierrez, WM and Khalil, A and Sandall, J and Copas, A and Lawlor, DA and Pasupathy, D and DESIGN, Trial team},
doi = {10.1186/s13063-021-05141-8},
journal = {Trials},
pages = {195--195},
title = {Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial-data management experience from the DESiGN Trial team.},
url = {http://dx.doi.org/10.1186/s13063-021-05141-8},
volume = {22},
year = {2021}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BACKGROUND: The use of electronic patient records for assessing outcomes in clinical trials is a methodological strategy intended to drive faster and more cost-efficient acquisition of results. The aim of this manuscript was to outline the data collection and management considerations of a maternity and perinatal clinical trial using data from electronic patient records, exemplifying the DESiGN Trial as a case study. METHODS: The DESiGN Trial is a cluster randomised control trial assessing the effect of a complex intervention versus standard care for identifying small for gestational age foetuses. Data on maternal/perinatal characteristics and outcomes including infants admitted to neonatal care, parameters from foetal ultrasound and details of hospital activity for health-economic evaluation were collected at two time points from four types of electronic patient records held in 22 different electronic record systems at the 13 research clusters. Data were pseudonymised on site using a bespoke Microsoft Excel macro and securely transferred to the central data store. Data quality checks were undertaken. Rules for data harmonisation of the raw data were developed and a data dictionary produced, along with rules and assumptions for data linkage of the datasets. The dictionary included descriptions of the rationale and assumptions for data harmonisation and quality checks. RESULTS: Data were collected on 182,052 babies from 178,350 pregnancies in 165,397 unique women. Data availability and completeness varied across research sites; each of eight variables which were key to calculation of the primary outcome were completely missing in median 3 (range 1-4) clusters at the time of the first data download. This improved by the second data download following clarification of instructions to the research sites (each of the eight key variables were completely missing in median 1 (range 0-1) cluster at the second time point). Common data management challenges were harmonising a
AU  - Relph,S
AU  - Elstad,M
AU  - Coker,B
AU  - Vieira,MC
AU  - Moitt,N
AU  - Gutierrez,WM
AU  - Khalil,A
AU  - Sandall,J
AU  - Copas,A
AU  - Lawlor,DA
AU  - Pasupathy,D
AU  - DESIGN,Trial team
DO  - 10.1186/s13063-021-05141-8
EP  - 195
PY  - 2021///
SN  - 1745-6215
SP  - 195
TI  - Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial-data management experience from the DESiGN Trial team.
T2  - Trials
UR  - http://dx.doi.org/10.1186/s13063-021-05141-8
UR  - https://www.ncbi.nlm.nih.gov/pubmed/33685512
UR  - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05141-8
UR  - http://hdl.handle.net/10044/1/91061
VL  - 22
ER  -
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