A Qualitative Investigation to Develop an Adapted Version of the EQ-5D-Y-3L for Use in Children Aged 2-4 Years.

OBJECTIVES: Few preference-weighted health-related quality-of-life measures exist for children under 5 years of age. Young children are substantial consumers of healthcare services. This project aims to assess EQ-5D-Y-3L's appropriateness in children aged 2 to 4 years and to coproduce with parents a suitable adaptation. METHODS: Purposive sampling at the Murdoch Children's Research Institute and Royal Children's Hospital was used to recruit parents or carers of children aged 2 to 4 years in Australia. Online focus groups were conducted consisting of 13 parents of healthy children, and 6 parents of children with moderate to severe health conditions. Parents provided feedback on each dimension of the proxy EQ-5D-Y-3L. Recordings were transcribed and thematic analysis was conducted. Qualitative findings guided the design of adaptations to the instrument. The adaptations were piloted to obtain feedback and refined to improve language translatability and comparability with other EuroQol instruments. RESULTS: The adapted EQ-5D-Y-3L was considered generally acceptable by the parents. Parents provided a wide range of examples of how each domain related to their children, with varied examples provided across ages 2 to 4 years and health status. Additional or alternative wording was suggested by parents to improve the applicability of the instrument to this age group. One example of this was the change of the domain wording "walking about" to "movement"-ID5:"In this age group, movement is more important than walking." CONCLUSIONS: The adapted EQ-5D-Y-3L has improved relevance for 2-4-year olds and appears easy to complete. Further testing of the adapted instrument is required to evaluate acceptability, reliability, and validity.

Collecting Paediatric Health-Related Quality of Life Data: Assessing the Feasibility and Acceptability of the Australian Paediatric Multi-Instrument Comparison (P-MIC) Study.

BACKGROUND: Collecting data using paediatric health-related quality of life (HRQoL) instruments is complex, and there is a paucity of evidence regarding the comparative performance of paediatric HRQoL instruments. The Australian Paediatric Multi-Instrument Comparison (P-MIC) study was conducted to address this paucity of evidence. This study aims to understand the (1) feasibility of collecting data using paediatric HRQoL instruments in a research setting and (2) acceptability and feasibility for children and their caregivers to complete common paediatric HRQoL instruments using data from the Australian P-MIC study. METHODS: Data were from children aged 5-18 years from the Australian P-MIC study. Demographics, cost and time for data collection, dropout rates, and inconsistent responses were used to assess Aim 1. Participant-reported difficulty and completion time were used to assess Aim 2. Subgroup analyses included child age, report type (self/proxy), sample recruitment pathway (hospital/online), and online panel sample type (general population/condition groups). RESULTS: Overall, 5945 P-MIC participants aged 5-18 years completed an initial survey, of these, 2346 also completed the follow-up survey (39.5% response rate). Compared with online panel recruitment, hospital recruitment was more costly and time-consuming and had higher follow-up completion (33.5% versus 80.4%) (Aim 1). Data were of similar good quality (based on inconsistent responses) for both recruitment pathways (Aim 1). Participants completed each instrument in <3 min, on average, and >70% reported each instrument as easy to complete (Aim 2). CONCLUSIONS: The Australian P-MIC study was able to collect good-quality data using both online panel and hospital recruitment pathways. All instruments were acceptable and feasible to children and their caregivers.

Recruitment challenges and recommendations for adolescent obesity trials.

AIM: To report our experiences with recruiting overweight and obese 13- to 16-year-olds for the Loozit® weight management randomised control trial (RCT) and to identify effective strategies for recruiting adolescents from the community to a treatment trial. METHODS: The Loozit RCT is a two-arm, community-based, lifestyle intervention that aims to evaluate the effect of additional therapeutic contact provided via telephone coaching and electronic communications as an adjunct to the Loozit group programme. Strategic areas that were targeted to recruit adolescents included media, schools, health professionals and community organisations. The programme aimed to recruit a cohort of 12-16 adolescents (body mass index z-score range 1.0-2.5) aged 13-16 years every 3 months over 3 years. Information regarding recruitment and eligibility to participate was initially assessed during a telephone screen. The relative cost effectiveness of recruitment strategies was determined based on recruitment rates and costs including administrative costs and research assistant time. RESULTS: Out of 474 enquiries, 32% resulted in an enrollment to the RCT. Newspaper articles and school newsletters accounted for nearly 60% of enquiries and enrollments and were the most cost-effective recruitment strategies. Common reasons for ineligibility for inclusion in the RCT were adolescents being too young (21%) and parents consenting but adolescents refusing to participate (17%). CONCLUSIONS: The most successful recruitment strategies for the Loozit RCT were local newspapers and school newsletters. Future studies should consider involving a Public Relations department and other potentially cost-effective strategies such as peer recruitment.

Psychometric Performance of HRQoL Measures: An Australian Paediatric Multi-Instrument Comparison Study Protocol (P-MIC).

BACKGROUND: There is a lack of psychometric evidence about pediatric health-related quality of life (HRQoL) instruments. Evidence on cost effectiveness, involving the measurement of HRQoL, is used in many countries to make decisions about pharmaceuticals, technologies, and health services for children. Additionally, valid instruments are required to facilitate accurate outcome measurement and clinical decision making. A pediatric multi instrument comparison (P-MIC) study is planned to compare the psychometric performance and measurement characteristics of pediatric HRQoL instruments. METHODS: The planned P-MIC study will collect data on approximately 6100 Australian children and adolescents aged 2-18 years via The Royal Children's Hospital Melbourne and online survey panels. Participants will complete an initial survey, involving the concurrent collection of a range of pediatric HRQoL instruments, followed by a shorter survey 2-8 weeks later, involving the collection of a subset of instruments from the initial survey. Children aged ≥7 years will be asked to self-report HRQoL. Psychometric performance will be assessed at the instrument, domain, and item level. CONCLUSIONS: This paper describes the methodology of the planned P-MIC study, including benefits, limitations, and likely challenges. Evidence from this study will guide the choice of HRQoL measures used in clinical trials, economic evaluation, and other applications.