Patient-reported outcomes measure for children born preterm: validation of the SOLE VLBWI Questionnaire, a new quality of life self-assessment tool

Ivana Olivieri, Stefania M Bova, Elisa Fazzi, Daniela Ricci, Francesca Tinelli, Cristina Montomoli, Cristiana Rezzani, Umberto Balottin, Simona Orcesi, G. Ariaudo, L. Capone, S. Spairani, M. Stronati, T. Figar, Marica Mastrangelo, M. Mastrangelo, A. Krachmalnicoff, G. Lista, P. Accorsi, P. MartelliA. Rossi, S. Micheletti, M. Zaccagnino, G. Chirico, M. Mallardi, Michela Quintiliani, M. Quintiliani, Domenico Marco Romeo, Francesca Gallini, Roberta Battini, R. Battini, A. Comparini

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)


Aim: This study was conducted to develop and validate a new self-report questionnaire for measuring quality of life (QoL), at school age, in children with a very low birthweight (VLBW). Method: Through a focus group approach, children were involved directly in defining the questionnaire items, which were presented as illustrations rather than written questions. This preliminary validation of the questionnaire was conducted in 152 participants with VLBW (aged 7–11y) randomly selected from the five participating Italian centres. The questionnaire was completed by children and parents separately; data on children's demographic and medical history, and intellectual, adaptive, and behavioural functioning were collected using standardized scales. All the children also completed the Paediatric Quality of Life Inventory (PedsQL), another Italian-language measure of QoL in children. Results: Our questionnaire was readily accepted and understood, and quick to complete. The Cronbach's alpha value showed it to be a reliable instrument. The child-compiled version correlated well with the PedsQL, whereas no correlations emerged with the other scales used, IQ, or degree of impairment. Conversely, these variables correlated significantly with the parent-compiled version. Children's and parents’ answers were divergent on practically all the items. Interpretation: The results confirm the validity of the new instrument and highlight a poor overlap between parents’ and children's perspectives.
Original languageEnglish
Pages (from-to)957-964
Number of pages8
JournalDevelopmental Medicine and Child Neurology
Publication statusPublished - 2016


  • Child
  • Female
  • Humans
  • Infant, Very Low Birth Weight
  • Male
  • Patient Reported Outcome Measures
  • Psychometrics
  • Quality of Life
  • Reproducibility of Results
  • Self-Assessment
  • Surveys and Questionnaires


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