Written on behalf of the International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st)
If the idea of implementing and managing global research effectively, and uniformly, across eight global study sites sounds challenging, that’s because it is.
Confronted with the lack of evidence-based, universally-applicable growth charts for monitoring fetal, preterm and newborn growth, a network of researchers formed the International Fetal and Newborn Growth Consortium for the 21st Century to fill these gaps. Implemented in the US, the UK, Brazil, China, Oman, Kenya, Italy, and India, the project is by far the largest collaborative venture in the field of perinatal health research.
The results of the studies will now inform robust resources for monitoring growth and development in the first 1,000 days of life.
Uniform implementation of methodology in each of the eight study sites was critical to success. Controlling variability both within and between study sites ensured that the population-based data from all sites could be combined into a single data set that would inform new international growth standards. To achieve uniformity in such a large, multicenter project, all study sites followed the same standardized anthropometry procedures to measure newborns.
While each study site was unique, three generalizable “lessons learned” emerged from implementing and managing this global research project:
- Assemble the right team. Principal Investigators in each study site were responsible for recruiting a team of anthropometrists. The number of people within each team depended on various institutional characteristics, e.g. size of institution; availability full- or part-time staff. However, team members across all study sites were selected based on some universal criteria: motivation, education, skills, organizational capacity and language ability. Team members not only had to be skilled anthropometrists, they were also required to have the interpersonal skills needed to explain the protocols to parents and effectively measure newborns. Each study site had access to leadership throughout the project’s duration; lead anthropometrists were selected based on experience, leadership abilities, and availability, and a core expert group of anthropometrists from the Coordinating Unit were also key to ensuring standardization amongst the study sites. Dedicated data managers at each site were accountable for regularly uploading measurements to the central database.
- Train dynamically. Before data collection began, rigorous training and standardization sessions were conducted at each study site. These trainings were organized by the local lead anthropometrist and were supervised by an expert. The goals of these sessions were to ensure that measurers develop, refine, and maintain their techniques so that the measurements they yield would be repeatable and reproducible values. Training materials, including a protocol manual creating by the Coordinating Unit and an open-access training video, were used as resources in each site. These trainings covered the over-arching goals of taking measurements, as well as details that might affect the day-to-day measurement process, e.g. the measurer’s nerves, infant struggle, and air and light conditions. Frequent standardization sessions, i.e. every three months, functioned as audits to ensure anthropometry teams were following recommended techniques by monitoring the precision and accuracy of their measurements on real newborns. Hands-on corrections were made and explained, if required.
- Provide the right tools to achieve high standards. “Gold standards” of measuring newborns were established from the project’s outset. During standardization sessions, measuring and re-measuring would be performed by an anthropometrist and an expert to ensure consistency and model the expected behavior. Study sites were provided the same equipment and instructions on how to use it. The training materials developed by the Coordinating Unit leveraged open-access resources, such as an anthropometry training video and evidence-based measurement practices, when available. An online data management system provided central coordination of the data and provided built-in range and consistency checks.
The measurements gathered through the INTERGROWTH-21st Project form a unique and important data set that will advance our understandings of human growth and development. It is also interesting to note that the research team observes that implementing standardized anthropometric methodology in these study sites appears to have improved the overall quality of infant measurements in the participating health institutions.
For more information about the anthropometric protocols and how the research team standardized their quality, and the overall methodology of the INTERGROWTH-21st Project, please refer to the INTERGROWTH-21st Project’s supplement in the British Journal of Gynaecology and Obstetrics.