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Abstract
Background The assessment of language and cognition in children at risk of impaired neurodevelopment following neonatal care is a UK standard of care but there is no national, systematic approach for obtaining these data. To overcome these challenges, we developed and evaluated a digital version of a validated parent questionnaire to assess cognitive and language development at age 2 years, the Parent Report of Children’s Abilities-Revised (PARCA-R).
Methods We involved clinicians and parents of babies born very preterm who received care in north-west London neonatal units. We developed a digital version of the PARCA-R questionnaire using standard software. Following informed consent, parents received automated notifications and an invitation to complete the questionnaire on a mobile phone, tablet or computer when their child approached the appropriate age window. Parents could save and print a copy of the results. We evaluated ease of use, parent acceptability, consent for data sharing through integration into a research database and making results available to the clinical team.
Results Clinical staff approached the parents of 41 infants; 38 completed the e-registration form and 30 signed the e-consent. The digital version of the PARCA-R was completed by the parents of 21 of 23 children who reached the appropriate age window. Clinicians and parents found the system easy to use. Only one parent declined permission to integrate data into the National Neonatal Research Database for approved secondary purposes.
Discussion This electronic data collection system and associated automated processes enabled efficient systematic capture of data on language and cognitive development in high-risk children, suitable for national delivery at scale.
Introduction
The assessment of cognitive and language development in children born very preterm and/or at risk of impaired neurodevelopment following admission to neonatal care is a UK standard of care. The National Institute for Health and Care Excellence (NICE) recommends that babies born below 30 weeks’ gestation, or at 30–36 weeks’ gestation with additional risk factors for developmental problems and disorders, should be followed up to 2 years of age.1–3 These data are also essential for follow-up evaluations of babies who participate in obstetric and neonatal studies, for which neurodevelopmental impairment at 2 years of age is frequently a key outcome.4 In addition, neurodevelopmental outcomes comprise components of the core outcomes set for neonatal medicine, which clinicians, parents and researchers consider all clinical trials should record.5
In the UK, there is currently no national, systematic approach for assessing and recording the results of assessments of cognitive and language development in children born very preterm and other infants who are at risk of impaired neurodevelopment. Among many challenges are the need to keep in touch with families, the inconvenience of having to attend clinic appointments, the requirement for appropriately trained staff and the costs of follow-up assessments.
The present situation is that many children do not receive these assessments, and some receive separate assessments for clinical and research purposes. Additionally, many neonatal studies lack this important information because of the difficulty in securing funding for long-term follow-up. The lack of a uniform system also results in wide variation in the types of developmental assessments undertaken, making it difficult to harmonise and interpret data at a population level. When funding for research evaluations is available, children and their families often experience the burden of multiple separate assessments for clinical care and research, as there are no systematic processes for sharing data obtained as part of clinical practice for research and vice versa.
The Parent Report of Children’s Abilities-Revised (PARCA-R) is a standardised, norm-referenced, parent-completed questionnaire that can be used to assess cognitive and language development at 23–27 months of age and identify children with developmental delay.6 7 It is recommended by NICE as a clinical tool to assess the development of children born preterm1–3 and by The International Consortium for Health Outcomes Measurement for assessing development at 2 years of age for all children who were born preterm or hospitalised in the neonatal period.8 It is also widely used as an outcome measure in observational studies and clinical trials.9–15
For follow-up to be effective, parent participation must be high, and the data require secure storage and well-governanced processes for access. Here, we describe the development and refinement of a systematic approach to developmental follow-up using a digital version of the parent-completed PARCA-R and processes to incorporate the results into a mature well established, UK Health Research Authority approved national asset, the National Neonatal Research Database (NNRD)16 17 so that they can be used for approved secondary purposes with parent agreement.
Results
The clinical neonatal teams of north-west London NHS Trusts approached the parents of 41 children: 10 in London North West University Healthcare NHS Trust; 6 in Imperial College Healthcare NHS Trust; 8 in Chelsea & Westminster Hospital NHS Foundation Trust and 17 in Hillingdon Hospitals NHS Foundation Trust. For unknown reasons, 3 out of the 41 parents did not complete the registration form. Out of the 38 participants who completed the registration form, 16 children were girls and 22 were boys. Their gestational ages at birth ranged from 24 to 29 weeks. Twenty-three parents selected English as their first language, 14 selected other languages (Romanian, Turkish, Gujarati, Italian, Arabic, Mandarin, Albanian, Polish and Punjabi) and one was unsure. Of the 38 parents who completed the registration form, 30 completed and 1 started but did not complete the e-agreement (figure 2).
Numbers of participants.NHS: National Health Service
Out of the 41 parents who were invited to participate in the study, 34 were happy to be contacted by text or email and 7 only by text. Of the 34 that agreed to be contacted either way, 19 were randomly allocated to receive notifications by email only and 15 by text and email. Of the ones receiving notifications by email only, 13 (68%) signed the e-consent compared with 11 (73%) in the text plus email group. This difference became more marked when comparing questionnaire completion with 10 (53%) vs 11 (73%) in each group, respectively.
By the end of the study, 30 out of the 38 (79%) participants who signed the registration form went on to sign the e-consent. Of these, only one participant did not agree to have their baby’s data shared with the clinical team and to be integrated into the NNRD and only two did not agree to be contacted about future studies. Twenty-three of the 30 children reached the appropriate age window for completion of the PARCA-R questionnaire. For these, 21 parents (91%) completed it fully and correctly. Two (9%) were completed incorrectly, one because of erroneous enrolment after the child’s second birthday and one because the questionnaire was completed early, before the child was aged 23.5 months, due to a mistake by the clinician when entering the schedule of events.
This digital version of the PARCA-R questionnaire was completed well and it was possible to calculate standardised scores for all 21 children.
Following parent and clinician feedback, we refined the electronic processes. We included a link to the parent information leaflet within the e-agreement form so that parents could access this at any time. We limited the number of characters per notification to reduce the cost of text notifications. We modified standard OpenClinica terminology by replacing the word ‘subject’ with ‘participant’ and referred to ‘your child’, instead of ‘this child’. We resolved technical issues with the display of the PARCA-R scores using iOS in iPhones and a randomisation glitch. We introduced multifactor authentication to access the questionnaire. We modified the NHS number field within the registration form from numeric to text. Finally, we made programming changes to remove the capacity for a clinician to modify the schedule of events inadvertently.
Discussion
We successfully developed, piloted and refined an electronic system to obtain parent-reported data on cognitive and language development at 2 years of age in children born very preterm. The system was easy to use and acceptable to clinicians and parents. Parents were able to access information about the process and its purpose at any time and were able to complete the questionnaire on a choice of devices. They could choose if they wished to give permission for the questionnaire results to be incorporated into the NNRD, to be made available for other approved uses. They were also able to choose if they wished to receive future information that might be relevant to their child. Importantly, the results of the PARCA-R questionnaire were available to the clinical teams for use in routine developmental follow-up care and parents were able to save and print out a copy of their child’s results.
We were able to provide parents with notifications by email and text. Despite a slight increase in cost, this is a helpful option as some parents had no access to email. Overall, completion was higher in the group receiving dual notifications, rather than email alone. A current limitation is that while the PARCA-R questionnaire has been translated into 23 different languages (https://le.ac.uk/parca-r/translations), only a small proportion of those translations have been validated to ensure the appropriate selection of words in a culturally appropriate content. This is an important consideration for future development, as 40% of the participants in our study did not consider English their primary language.
The study period overlapped with the COVID-19 pandemic and the alterations to service provision may have affected uptake. We are unable to say whether this was to enhance or decrease uptake.
Conclusions
The success of this study suggests that electronic collection of parent-reported data on cognitive and language development for children born very preterm is feasible and suitable for national scale-up. It could improve the clinical care of individual children as well as the efficiency of clinical trials and other studies and reduce the costs of obtaining data on cognitive and language development at the age of 2 years. The incorporation of the results into the NNRD, thereby making these data available to other researchers for approved purposes would mean sparing children and their families the burden of repeated assessments. It would also enable systematic exploration of outcomes in complete populations of children. Finally, use of a single measure at 2 years of age would obviate the need to harmonise data from multiple developmental tests.
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