ESPE Abstracts (2016) 86 P-P1-639

Spanish ECOS Study Analysis: Socioeconomic Data, Adherence and Growth Outcomes with Case Studies

Maria Rodríguez-Arnaoa, Amparo Rodríguez Sáncheza, Ignacio Díez Lópezb, Joaquín Ramírez Fernándezc, Jose Bermúdez de la Vegad, Virginia Ballanoe, Jenny Alvarez Nietof & Ekaterina Koledovag


aHospital General Universitario Gregorio Marañón, Madrid, Spain; bHospital Universitario Araba, Araba/Alava, Spain; cHospital Universitario Príncipe de Asturias, Madrid, Spain; dCentro Nuevas Tecnologias, Sevilla, Spain; eRegional Clinical Operations, Merck S.L., Madrid, Spain; fMedical Affairs, Merck S.L., Madrid, Spain; gGlobal Medical, Merck KGaA, Darmstadt, Germany


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 patient’s 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.