Volume 2013 Supplement 1

7th Asia Pacific Paediatric Endocrine Society (APPES) Biennial Scientific Meeting

Open Access

Quantifying adherence to growth hormone treatment: the easypod™ connect observational study (ECOS)

  • Peter Davies1,
  • Ho-Seong Kim2,
  • Martin Borkenstein3,
  • Minlian Du4,
  • Jeremy Kirk5,
  • Ludmila Kostalova6,
  • Jan Lebl7,
  • Sandro Loche8,
  • Andrea Luczay9,
  • Marc Nicolino10,
  • Svante Norgren11,
  • Dolores Rodriguez Arnao12,
  • John Vandermeulen13,
  • Christoph Gasteyger14,
  • Jürgen Zieschang15 and
  • Monia Zignani14
International Journal of Pediatric Endocrinology20132013(Suppl 1):P46

https://doi.org/10.1186/1687-9856-2013-S1-P46

Published: 3 October 2013

Recombinant human growth hormone (r-hGH) is indicated for pediatric patients with a variety of growth disorders. Until recently, analysis of adherence to treatment has been limited by recall bias and reliance on self-reporting. Accurate recorded data on r-hGH use can now be collected using the easypod™ auto-injector. The multinational easypod™ connect observational study (ECOS) was launched in 2010 to collect and analyze r-hGH dosing, clinical and auxological data from patients prescribed r-hGH via easypod™. Twelve countries are currently recruiting patients.

The primary objective is to assess adherence in patients receiving r-hGH via easypod™. Secondary objectives include describing the impact of adherence on clinical outcomes and identifying adherence patterns.

Data will be obtained from patients’ medical notes and uploaded from auto-injectors. Auxological parameters are collected, and prescribed dosing data recorded at clinic visits as per routine clinical practice. Annual adherence will be calculated (number of days the patient administered injections divided by the expected number of injection days over 1 year, as a percentage). Dose intensity (total amount of dose received divided by planned amount of dose over 1 year, as a percentage) will be analyzed. Adherence data will be correlated with clinical outcomes. An adherence pattern will also be developed based on patients’ age, sex, indication, self-injection, and time on treatment. The study will run until 2015, with yearly analyses, and will be overseen by a multinational scientific steering committee.

With data from ECOS, it will be possible to accurately assess r-hGH treatment adherence in various growth disorders and explore its potential impact on growth. Ultimately, drivers of and barriers to treatment adherence will be identified, allowing appropriate support programs to be developed.

Authors’ Affiliations

(1)
University of Queensland
(2)
Yonsei University
(3)
Med.Univ.Graz
(4)
First affiliated Hospital of Sun Yat-sen University Guangzhou
(5)
Birmingham Children's Hospital
(6)
Comenius University Medical School
(7)
Charles University in Prague
(8)
Ospedale Microcitemico - ASL Cagliari
(9)
Semmelweis University
(10)
Lyon University
(11)
Karolinska University Hospital
(12)
Hospital Universitario Gregorio Marañón
(13)
McMaster Children's Hospital and McMaster University
(14)
Merck Serono S.A
(15)
Merck KGaA

Copyright

© Davies et al; licensee BioMed Central Ltd. 2013

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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