Background: The ECOS observational study in Spain (NCT01376921) aims to evaluate adherence to r-hGH therapy prescribed via the easypod electromechanical auto-injector device and to analyse factors that may influence adherence in paediatric patients. Easypod administers pre-set doses of Saizen® r-hGH and stores accurate records of each dose and injection taken, which can then be shared with the HCP for evaluation of the patients adherence.
Objective and hypotheses: To assess the use and acceptability of easypod and adherence to r-hGH therapy, to highlight individual patients dosing patterns and growth outcomes and to assess the socioeconomic background of caregivers responsible for administering injections.
Method: Adherence was determined categorically and also as %adherence over time, defined as the number of days with injections received, divided by the number of days with injections planned. Accurate individual adherence data were transcribed directly from the patients easypod while socioeconomic, demographic, auxological and diagnostic data were obtained from medical notes.
Results: The Spanish cohort consisted of 280 children, of whom 240 were included in the final analysis set (52% male). The majority were Caucasian (93.8%), with a diagnosis of GH deficiency (GHD, 60.0%), small for gestational age (SGA, 35.8%), Turner Syndrome (TS, 3.3%) or chronic renal failure (CRF, 0.83%). Despite high overall adherence (median 98.8%, mean 94.5% [95% CI 92.8, 96.3]), growth responses varied and patterns of missed doses proved highly individual and, in some cases, fluctuated over time, possibly reflecting changes in caregiver or other life circumstances. Almost 80% of injection-giving carers were employed, while 31.5% had degree level education, 35.0% had only had school level education, 9.5% had other education and 22% had not had this recorded.
Conclusion: The majority of children adhere extremely well to their treatment regimen using the easypod device. Individual cases show distinctive patterns of adherence and growth outcomes.
10 Sep 2016 - 12 Sep 2016