Informatics Methodology Used in the Web-Based Portal of the NASCITA Cohort Study: Development and Implementation Study

Michele Zanetti, Antonio Clavenna, Chiara Pandolfini, Claudia Pansieri, Maria Grazia Calati, Massimo Cartabia, Daniela Miglio, Maurizio Bonati, Michele Zanetti, Antonio Clavenna, Chiara Pandolfini, Claudia Pansieri, Maria Grazia Calati, Massimo Cartabia, Daniela Miglio, Maurizio Bonati

Abstract

Background: Many diseases occurring in adults can be pinned down to early childhood and birth cohorts are the optimal means to study this connection. Birth cohorts have contributed to the understanding of many diseases and their risk factors.

Objective: To improve the knowledge of the health status of Italian children early on and how it is affected by social and health determinants, we set up a longitudinal, prospective, national-level, population-based birth cohort, the NASCITA study (NAscere e creSCere in ITAlia). The main aim of this cohort is to evaluate physical, cognitive, and psychological development; health status; and health resource use in the first 6 years of life in newborns, and potential associated factors. A web-based system was set up with the aim to host the cohort; provide ongoing information to pediatricians and to families; and facilitate accurate data input, monitoring, and analysis. This article describes the informatics methodology used to set up and maintain the NASCITA cohort with its web-based platform, and provides a general description of the data on children aged over 7 months.

Methods: Family pediatricians were contacted for participation in the cohort and enrolled newborns from April 2019 to July 2020 at their first well-child visit. Information collected included basic data that are part of those routinely collected by the family pediatricians, but also parental data, such as medical history, characteristics and lifestyle, and indoor and outdoor environment. A specific web portal for the NASCITA cohort study was developed and an electronic case report form for data input was created and tested. Interactive data charts, including growth curves, are being made available to pediatricians with their patients' data. Newsletters covering the current biomedical literature on child cohorts are periodically being put up for pediatricians, and, for parents, evidence-based information on common illnesses and problems in children.

Results: The entire cohort population consists of 5166 children, with 139 participating pediatricians, distributed throughout Italy. The number of children enrolled per pediatrician ranged from 1 to 100. The 5166 enrolled children represent 66.55% (5166/7763) of the children born in all of 2018 covered by the same pediatricians participating in the cohort. The number of children aged over 7 months at the time of these analyses, and for whom the most complete data were available upon initial analyses, was 4386 (2226/4381 males [50.81%] and 142/4370 twins [3.25%]). The age of the mothers at birth of the 4386 children ranged from 16 to 54 years. Most newborns' mothers (3758/4367, 86.05%) were born in Italy, followed by mothers born in Romania (101/4367, 2.31%), Albania (75/4367, 1.72%), and Morocco (60/4367, 1.37%). Concerning the newborns, 138/4386 (3.15%) were born with malformations and 352/4386 (8.03%) had a disease, most commonly neonatal respiratory distress syndrome (n=52), neonatal jaundice (n=46), and neonatal hypoglycemia (n=45).

Conclusions: The NASCITA cohort is well underway and the population size will permit significant conclusions to be drawn. The key role of pediatricians in obtaining clinical data directly, along with the national-level representativity, will make the findings even more solid. In addition to promoting accurate data input, the multiple functions of the web portal, with its interactive platform, help maintain a solid relationship with the pediatricians and keep parents informed and interested in participating.

Trial registration: ClinicalTrials.gov NCT03894566; https://ichgcp.net/clinical-trials-registry/NCT03894566.

Keywords: cohort studies; computer systems; infant; internet; newborn; pediatricians.

Conflict of interest statement

Conflicts of Interest: None declared.

©Michele Zanetti, Antonio Clavenna, Chiara Pandolfini, Claudia Pansieri, Maria Grazia Calati, Massimo Cartabia, Daniela Miglio, Maurizio Bonati. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 12.03.2021.

Figures

Figure 1
Figure 1
The 21 geographic clusters, identified based on ISTAT geographic and administrative criteria. ISTAT: Italian National Statistics Institute.
Figure 2
Figure 2
Functions of the platform and its architecture.
Figure 3
Figure 3
Individual child’s data plotted on growth curve, as seen by the pediatrician.
Figure 4
Figure 4
eCRF screenshots: input for second visit.
Figure 5
Figure 5
eCRF dashboard for checking completeness of data on the visits for individual patients.

References

    1. Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Barón E, Grantham-McGregor S, Lancet Early Childhood Development Series Steering Committee Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 07;389(10064):77–90. doi: 10.1016/S0140-6736(16)31389-7.
    1. Barouki R, Gluckman PD, Grandjean P, Hanson M, Heindel JJ. Developmental origins of non-communicable disease: implications for research and public health. Environ Health. 2012 Jun 27;11:42. doi: 10.1186/1476-069X-11-42.
    1. Fleming TP, Watkins AJ, Velazquez MA, Mathers JC, Prentice AM, Stephenson J, Barker M, Saffery R, Yajnik CS, Eckert JJ, Hanson MA, Forrester T, Gluckman PD, Godfrey KM. Origins of lifetime health around the time of conception: causes and consequences. Lancet. 2018 May 05;391(10132):1842–1852. doi: 10.1016/S0140-6736(18)30312-X.
    1. Larsen PS, Kamper-Jørgensen M, Adamson A, Barros H, Bonde JP, Brescianini S, Brophy S, Casas M, Charles M, Devereux G, Eggesbø M, Fantini MP, Frey U, Gehring U, Grazuleviciene R, Henriksen TB, Hertz-Picciotto I, Heude B, Hryhorczuk DO, Inskip H, Jaddoe VWV, Lawlor DA, Ludvigsson J, Kelleher C, Kiess W, Koletzko B, Kuehni CE, Kull I, Kyhl HB, Magnus P, Momas I, Murray D, Pekkanen J, Polanska K, Porta D, Poulsen G, Richiardi L, Roeleveld N, Skovgaard AM, Sram RJ, Strandberg-Larsen K, Thijs C, Van EM, Wright J, Vrijheid M, Andersen AN. Pregnancy and birth cohort resources in europe: a large opportunity for aetiological child health research. Paediatr Perinat Epidemiol. 2013 Jul;27(4):393–414. doi: 10.1111/ppe.12060.
    1. Thompson L, Kemp J, Wilson P, Pritchett R, Minnis H, Toms-Whittle L, Puckering C, Law J, Gillberg C. What have birth cohort studies asked about genetic, pre- and perinatal exposures and child and adolescent onset mental health outcomes? A systematic review. Eur Child Adolesc Psychiatry. 2010 Jan;19(1):1–15. doi: 10.1007/s00787-009-0045-4. doi: 10.1007/s00787-009-0045-4.
    1. Baxter-Jones AD, Cardy AH, Helms PJ, Phillips DO, Smith WC. Influence of socioeconomic conditions on growth in infancy: the 1921 Aberdeen birth cohort. Arch Dis Child. 1999 Jul;81(1):5–9. doi: 10.1136/adc.81.1.5.
    1. Framingham Heart Study. [2021-02-16].
    1. Nurses' Health Study. [2021-02-16].
    1. Pearson H. Children of the 90s: Coming of age. Nature. 2012 Apr 11;484(7393):155–8. doi: 10.1038/484155a.
    1. . [2021-02-16].
    1. Porta D, Fantini M.P. Prospective cohort studies of newborns in Italy to evaluate the role of environmental and genetic characteristics on common childhood disorders. Ital J Pediatr. 2006 Dec;32:350–357.
    1. Porta D, Forastiere F, Di Lallo D, Perucci CA, Grupo Collaborativo GASPII [Enrolment and follow-up of a birth cohort in Rome] Epidemiol Prev. 2007;31(6):303–8.
    1. Lanari M, Vandini S, Adorni F, Prinelli F, Di Santo S, Silvestri M, Musicco M, Study Group of Italian Society of Neonatology on Risk Factors for RSV Hospitalization Prenatal tobacco smoke exposure increases hospitalizations for bronchiolitis in infants. Respir Res. 2015 Dec 22;16:152. doi: 10.1186/s12931-015-0312-5.
    1. Barchitta M, Maugeri A, La Rosa MC, Magnano San Lio R, Favara G, Panella M, Cianci A, Agodi A. Single Nucleotide Polymorphisms in Vitamin D Receptor Gene Affect Birth Weight and the Risk of Preterm Birth: Results From the. Nutrients. 2018 Aug 27;10(9):1172. doi: 10.3390/nu10091172.
    1. Brescianini S, Fagnani C, Toccaceli V, Medda E, Nisticò L, D'Ippolito C, Alviti S, Arnofi A, Caffari B, Delfino D, Ferri M, Penna L, Salemi M, Sereni S, Serino L, Cotichini R, Stazi MA. An update on the Italian Twin Register: advances in cohort recruitment, project building and network development. Twin Res Hum Genet. 2013 Feb;16(1):190–6. doi: 10.1017/thg.2012.85.
    1. Richiardi L, Baussano I, Vizzini L, Douwes J, Pearce N, Merletti F. Feasibility of recruiting a birth cohort through the Internet: the experience of the NINFEA cohort. Eur J Epidemiol. 2007;22(12):831–7. doi: 10.1007/s10654-007-9194-2.
    1. Farchi S, Forastiere F, Vecchi Brumatti L, Alviti S, Arnofi A, Bernardini T, Bin M, Brescianini S, Colelli V, Cotichini R, Culasso M, De Bartolo P, Felice L, Fiano V, Fioritto A, Frizzi A, Gagliardi L, Giorgi G, Grasso C, La Rosa F, Loganes C, Lorusso P, Martini V, Merletti F, Medda E, Montelatici V, Mugelli I, Narduzzi S, Nisticò L, Penna L, Piscianz E, Piscicelli C, Poggesi G, Porta D, Ranieli A, Rapisardi G, Rasulo A, Richiardi L, Rusconi F, Serino L, Stazi MA, Toccaceli V, Todros T, Tognin V, Trevisan M, Valencic E, Volpi P, Ziroli V, Ronfani L, Di Lallo D. Piccolipiù, a multicenter birth cohort in Italy: protocol of the study. BMC Pediatr. 2014 Feb 07;14:36. doi: 10.1186/1471-2431-14-36.
    1. Valent F, Mariuz M, Bin M, Little D, Mazej D, Tognin V, Tratnik J, McAfee AJ, Mulhern MS, Parpinel M, Carrozzi M, Horvat M, Tamburlini G, Barbone F. Associations of prenatal mercury exposure from maternal fish consumption and polyunsaturated fatty acids with child neurodevelopment: a prospective cohort study in Italy. J Epidemiol. 2013 Sep 05;23(5):360–70. doi: 10.2188/jea.je20120168.
    1. Lanari M, Prinelli F, Adorni F, Di Santo S, Vandini S, Silvestri M, Musicco M, Study Group of Italian Society of Neonatology on Risk Factors for RSV Hospitalization Risk factors for bronchiolitis hospitalization during the first year of life in a multicenter Italian birth cohort. Ital J Pediatr. 2015 May 26;41:40. doi: 10.1186/s13052-015-0149-z.
    1. Bonati M, Campi R. What can we do to improve child health in southern Italy? PLoS Med. 2005 Sep;2(9):e250. doi: 10.1371/journal.pmed.0020250.
    1. Landi S, Ivaldi E, Testi A. Socioeconomic status and waiting times for health services: An international literature review and evidence from the Italian National Health System. Health Policy. 2018 Apr;122(4):334–351. doi: 10.1016/j.healthpol.2018.01.003.
    1. Pansieri C, Clavenna A, Pandolfini C, Zanetti M, Calati MG, Miglio D, Cartabia M, Zanetto F, Bonati M. NASCITA Italian birth cohort study: a study protocol. BMC Pediatr. 2020 Feb 19;20(1):80. doi: 10.1186/s12887-020-1961-1.
    1. Nascere e crescere in Italia (Coorte NASCITA) [2021-02-16].
    1. Istituto Italiano di Statistica (ISTAT) Main geographic statistics on cities. [2021-02-16]. .
    1. Corsello G, Ferrara P, Chiamenti G, Nigri L, Campanozzi A, Pettoello-Mantovani M. The Child Health Care System in Italy. J Pediatr. 2016 Oct;177S:S116–S126. doi: 10.1016/j.jpeds.2016.04.048.
    1. Bonati M, Reale L, Zanetti M, Cartabia M, Fortinguerra F, Capovilla G, Chiappedi M, Costantino A, Effedri P, Luoni C, Martinelli O, Molteni M, Ottolini A, Saccani M, Lombardy ADHD Group A Regional ADHD Center-Based Network Project for the Diagnosis and Treatment of Children and Adolescents With ADHD. J Atten Disord. 2018 Oct;22(12):1173–1184. doi: 10.1177/1087054715599573.
    1. Zanetti M, Campi R, Olivieri P, Campiotti M, Faggianelli A, Bonati M. A Web-Based Form With Interactive Charts Used to Collect and Analyze Data on Home Births in Italy. J Med Internet Res. 2019 Mar 22;21(3):e10335. doi: 10.2196/10335.
    1. GitLab Gatherings Crafter. [2020-07-20]. .
    1. Pansieri C, Pandolfini C, Clavenna A, Choonara I, Bonati M. An Inventory of European Birth Cohorts. Int J Environ Res Public Health. 2020 Apr 28;17(9):3071. doi: 10.3390/ijerph17093071.
    1. de Waure C, Bruno S, Furia G, Di Sciullo L, Carovillano S, Specchia ML, Geraci S, Ricciardi W. Health inequalities: an analysis of hospitalizations with respect to migrant status, gender and geographical area. BMC Int Health Hum Rights. 2015 Feb 07;15:2. doi: 10.1186/s12914-014-0032-9.
    1. Lauria L, Spinelli A, Buoncristiano M, Nardone P. Decline of childhood overweight and obesity in Italy from 2008 to 2016: results from 5 rounds of the population-based surveillance system. BMC Public Health. 2019 May 21;19(1):618. doi: 10.1186/s12889-019-6946-3.
    1. JavaScript Object Notation. [2021-02-16]. .

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