The need for a population-based longitudinal databank
Population-based data repositories can foster innovative research breakthroughs for conditions in which complex interactions of genetic, molecular, disease and social/environmental susceptibility may impact upon disease risk or treatment - such as congenital hearing loss.
The need for population-based research in children's hearing loss has been clearly articulated by the Centers for Disease Control and US National Institutes of Health.
The Victorian Infant Hearing Screening Program (VIHSP) provides a coordinated platform for the recruitment of children with permanent hearing loss in Victoria. VicCHILD offers an efficient and flexible population-based register and database for research into congenital hearing impairment.
Ultimately, we expect VicCHILD to lead to a greater understanding of developmental, health and wellbeing outcomes for hearing-impaired children and their families, flowing on to greater societal and economic participation in adulthood.
Our specific objectives are to facilitate population-based research that will:
- Describe secular trends in outcomes over time for repeated birth cohorts;
- Support population-based quality improvement activities over time;
- Identify and quantify factors that predict outcomes; and
- Facilitate randomised controlled trials of new management and treatment approaches.
Why is VicCHILD unique?
- To our knowledge, VicCHILD is the first population-based prospective data repository for congenital hearing loss in the world; neither the US nor the UK has the supporting intervention or administrative population outcomes databases essential to such an initiative.
- VicCHILD requests parent permission for access to an unequalled range of existing rich and accurate administrative datasets; thus, the burden on individual parents will be low; this will maximise participation (including groups that are often difficult to reach), retention and value.
- With a multidisciplinary team and Advisory Group, we hope it will provide new opportunities for research collaborations across varying disciplines and organisations and, further, facilitate research relationships in other states and worldwide. As well as otolaryngologists, the Advisory Group includes representatives of all three early intervention agencies, government policy departments, geneticists and ethical advisors.
- As the power of the Victorian hospital-based BioGrid data linkage system grows, we hope that VicCHILD will be able to link to hospital-based information such as results of pathology and MRI scans - of great value to otolaryngological research.
- VicCHILD has the potential to identify novel biomarkers associated with congenital hearing loss, via comprehensive genetic studies. Both retrospectively (via Newborn Screening Cards) and prospectively (via collection of buccal samples).
- VicCHILD will remain in existence indefinitely as a resource for informing research questions which will arise over time. We anticipate that after ten years of operation, VicCHILD will hold data and biological specimens for over 1200 Victorian children and their families, with VicCHILD's importance and value being ongoing, long lasting and unique.
How will VicCHILD foster new research collaborations?
Confidentialised VicCHILD data will be made available to researchers and research institutions to formulate and test their own research hypotheses, once access has been granted to requested data. Secondary objectives in establishing VicCHILD are therefore to:
- Facilitate new partnerships, training opportunities and capacity amongst Victorian researchers for population-based research in congenital hearing impairment;
- Develop research collaborations Australia wide and internationally, providing the blueprint for successful replication of VicCHILD in other locations
- Present the findings to the wider community through publications and media.
What data does VicCHILD collect?
There are three types of information collected by VicCHILD:
1. Information collected directly from children and their families (via questionnaires and assessments).
About the child:
- Birth information (weight, gestational age, birth type etc.).
- Quality of life (PedsQL)
- General development (Ages and Stages Questionnaire; Strengths & Difficulties Questionnaire)
- Health utilities index (HUI)
About the parent/family:
- Language spoken in the home
- Household data (income, disability/health care card status etc.).
- Number of siblings (including presence of hearing loss)
- Brief family history
2. Biobank storage/access to:
3. Retrieval/linkage to already available state and national health and education data.
What other information is VicCHILD accessing/linking to?
Additional data will be linked to or retrieved through available Victorian services and organisations. The secure transfer of information provides rich data while ensuring the burden of participation for families remains low.
- Health services
- Victorian Infant Hearing Screening Program
- Victorian Perinatal Data Collection
- Victorian Birth Defects Register
- Australian Hearing
- Royal Eye and EarHospital Data
- Cochlear Implant Clinic data
- Medicare/PBS data
- Hospital admissions data
- Educational services
- School Entry Health Questionnaire
- Australian Early Development Index
- National Assessment Program - Language and Literacy (NAPLAN)
- Victorian Certificate of Education (VCE)/ Victorian Certificate of Applied Learning (VCAL)
VicCHILD participants and recruitment
Children joining VicCHILD were born in Victoria with a permanent congenital sensorineural loss (mild-severe) or auditory neuropathy.
There are two distinct pathways of recruitment for VicCHILD - prospective and retrospective, bringing in children of all ages.
The Victorian Infant Hearing Screening Program (VIHSP) will approach, on VicCHILD's behalf, all families whose child is diagnosed with a mild or greater sensorineural congenital hearing or auditory neuropathy when the child is around six months of age (minimum of 12 weeks from a confirmed diagnosis). This recruitment started in 2012, and will continue indefinitely as more children are diagnosed with a hearing loss each year.
We anticipate that ≈110 families will be eligible each year, with around 80 families agreeing to join (based on 70% uptake).
Three one-off retrospective recruitment processes will occur, with participants from the previous years of VIHSP screening and from two projects at the Centre for Community Child Health.
The retrospective recruitment will boost early VicCHILD participant numbers, allowing for important output within the first three years of its existence, and will capitalise on the rich data already collected at considerable cost:
- Approximately 135 families from SCOUT, with around 95 children anticipated to join. In 2012, these children will be 7-9 years of age.
- Approximately 85 young adults (aged 19-20 years) from the CHIVOS project. CHIVOS was a longitudinal population-based cohort of 88 children, followed across 3 waves of data collection.
- Approximately 485 children diagnosed through VIHSP in the years 2005-2012.
VicCHILD has been given ethical approval by The Royal Children's Hospital (RCH) Human Research Ethical Committee (HREC). The RCH HREC is constituted and operates in accordance with the NHMRC National Statement on Ethical Conduct in Research Involving Humans (2007).
Participants or their parent/guardian (dependent on age appropriateness) provide detailed consent before any information or samples are collected. Families are able to specify which types of data they would like to contribute to VicCHILD (i.e. a family can provide consent to link their child's data, and decline to contribute a genetic sample).
How can outside researchers' access the data?
We anticipate data being available for researchers outside of VicCHILD from January 2013. Formal request processes will be in place for providing researchers with de-identified data for their own ethically approved research. For more information about the data available, or how data can be accessed please contact the VicCHILD team on (03) 9345 4215 or firstname.lastname@example.org.