Background: The Easypod Connect Observational Study (ECOS) observational study follows children with GHD, SGA and Turner syndrome receiving r-hGH therapy for up to 5 years, with interim analyses each year. The easypod electromechanical auto-injector device enables accurate, real-world digital records of patients adherence to rhGH to be collected for evaluation.
Objective and hypotheses: The primary objective of ECOS is to evaluate the level of adherence of paediatric patients receiving rhGH via easypod; secondary objectives are to assess the impact of adherence on clinical outcomes and concentrations of IGF1 and to identify factors that may influence adherence to this form of treatment.
Method: Demographic, auxological and diagnostic data are obtained from medical notes, with adherence data obtained directly from the patients easypod. Adherence is defined as days with injections received, divided by days with injections planned, expressed as a percentage. An interim global analysis was completed in 2014. Interim analyses have also been completed for the Nordic countries (Norway, Sweden, Finland), France and Canada. The real-world use of easypod (routine visits/year, local easypod data upload methodology, etc) in these analyses was compared to assess any country-specific differences.
Results: At the time of analysis, 1 972 patients had been enrolled globally, mean age 9.8 years; Canada n=204, mean age 10.9 years; France n=220, 9.4 years; Nordic n=150, 8.6 years. Individual levels of adherence prospectively measured with easypod (median (Q1, Q3), 93.0% (82.8%, 97.5%)) were higher than those previously reported in retrospective studies based on questionnaires and were maintained over time. Median 9-month adherence rates in the countries analysed were similarly high: Canada 96.9, France 94.9, Nordic 97.3%.
Conclusion: Adherence rates with the easypod device are high and maintained over time. Different age range at baseline and possible differences in clinical practice did not appear to have any major impact on easypod adherence rates in different countries.
Conflict of interest: Professor Peter Davies has received a research grant as an investigator and honoraria as a committee member from Merck Serono.
Funding: This study is funded by Merck KGaA, Darmstadt, Germany.
01 - 03 Oct 2015
European Society for Paediatric Endocrinology