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Comparing two methods of follow up in a multicentre randomised trial
Insights
Parental questionnaires show promise for assessing outcomes in children treated for post-hemorrhagic ventricular dilatation. This method effectively identifies disabled children, aiding multicenter randomized trials.
Area of Science:
- Pediatric Medicine
- Clinical Trial Methodology
- Developmental Pediatrics
Background:
- Post-hemorrhagic ventricular dilatation (PHVD) is a serious complication in preterm infants.
- Accurate outcome measures are crucial for evaluating PHVD treatments in clinical trials.
- Parental input can offer valuable insights into a child's functional status.
Purpose of the Study:
- To assess the utility of a parental questionnaire for outcome measurement in a PHVD trial.
- To compare parental assessments with objective pediatric evaluations.
- To determine if parental responses can categorize child disability levels.
Main Methods:
- A questionnaire was administered to parents of 88 PHVD survivors before a 30-month pediatric assessment.
- Parental responses were compared with detailed pediatric findings, including Griffiths' mental development scales.
- A model using parental responses categorized children's disability (normal, impaired, disabled).
Main Results:
- High agreement between parents and pediatricians was observed for gross motor function (81-99%), feeding (91-99%), and language (85-93%).
- Parents identified 60% of disabled children, closely matching the pediatrician's assessment (66%).
- Parents accurately identified most severely disabled children, though less precise with subtle impairments.
Conclusions:
- Parental questionnaires demonstrate significant potential as outcome measures in PHVD trials.
- The methodology shows encouragement for further development and application in comparative group studies.
- This approach may enhance data collection efficiency and richness in pediatric clinical research.
Aims:
To evaluate a parental questionnaire as a means of providing outcome measures for a multicentre randomised controlled trial of treatment for post-haemorrhagic ventricular dilatation.
Methods:
The parents of 88 survivors were sent a questionnaire before a paediatric assessment at the age of 30 months. The parents' responses to individual questions taken mainly from the Griffiths' mental development scales and their perception of the child's ability to see and hear were compared with the paediatric findings. A model, based on the parents' responses to particular questions, allowed the categorisation of the children as normal, impaired, moderately or severely disabled; this was compared with similar categorisation based on the full paediatric assessment.
Results:
Agreement on items concerning gross motor function ranged between 81 and 99%, concerning dressing between 77 and 80%, concerning feeding between 91 and 99%, and concerning language between 85 and 93%. Similar proportions of children were identified as disabled by the parents (60%) and by the paediatrician (66%). Of 29 children who had developmental quotients less than 70, parents identified 28 as disabled, 18 of them as severely disabled. They were not so good at identifying children with impairments without functional loss.
Conclusions:
Further work is required but there is sufficient encouragement from the results to pursue this methodology further for use in comparing groups in randomised trials.