Managing data for the international, multicentre INTERGROWTH‐21^st Project

Abstract

The INTERGROWTH‐21st Project data management was structured incorporating both a centralised and decentralised system for the eight study centres, which all used the same database and standardised data collection instruments, manuals and processes. Each centre was responsible for the entry and validation of their country‐specific data, which were entered onto a centralised system maintained by the Data Coordinating Unit in Oxford. A comprehensive data management system was designed to handle the very large volumes of data. It contained internal validations to prevent incorrect and inconsistent values being captured, and allowed online data entry by local Data Management Units, as well as real‐time management of recruitment and data collection by the Data Coordinating Unit in Oxford. To maintain data integrity, only the Data Coordinating Unit in Oxford had access to all the eight centres' data, which were continually monitored. All queries identified were raised with the relevant local data manager for verification and correction, if necessary. The system automatically logged an audit trail of all updates to the database with the date and name of the person who made the changes. These rigorous processes ensured that the data collected in the INTERGROWTH‐21st Project were of exceptionally high quality.

The Distribution of Clinical Phenotypes of Preterm Birth Syndrome

“…Its distinguishing features were that gestational age was reliably determined by ultrasonography, and a standardized protocol was adopted for data collection, quality control and management, clinical definitions, anthropometric evaluation (including the same equipment and measures), and neonatal care. 18,[20][21][22] Preterm birth was defined from 16 weeks' rather than 20 weeks' gestation because the risk factors, causes, and recurrence risk for births between 16 and 20 weeks' gestation are very similar to those between 20 and 24 weeks' gestation. 10 We adjusted for possible site-specific effects that might influence care modalities and might be associated with differential mortality and morbidity across sites and preterm clusters.…”

“…A detailed description of the data monitoring, quality-control system, and data reliability appears elsewhere. 18 Preterm phenotypes were classified using a new conceptual framework 12 based on severe maternal, fetal, and placental conditions causally associated with preterm birth ( Table 1). Information about cervical length and dilation (signs of initiation of parturition) was unavailable; therefore, we evaluated signs of presentation on hospital admission: (1) regular contractions only; (2) preterm prelabor rupture of membranes (PPROM) with or without regular contractions; (3) bleeding with or without PPROM; and (4) no documented record of initiation of parturition.…”

The objectives, design and implementation of the INTERGROWTH‐21st Project

“…One example is our decision not to collect detailed individual nutritional intake from this well‐nourished, healthy population. A more detailed description of the data collection system, including the actual forms, and the quality control strategies is presented in another paper of this supplement 41 …”

Anthropometric Characterization of Impaired Fetal Growth

“…10,11 All supporting documentation and data collection forms were prepared by the Project Coordinating Unit, translated into the main local language, tested locally, and introduced into our electronic data management system (http://www.intergrowth21 .org.uk). 12 All forms were linked to reduce duplication and facilitate quality control measures.…”