Evidence map›Paper›PMID 32239476›Full record

Observational studyJournal of endocrinological investigation2020

Adherence to treatment in children with growth hormone deficiency, small for gestational age and Turner syndrome in Mexico: results of the Easypod™ connect observational study (ECOS).

A Blanco-López, C Antillón-Ferreira, E Saavedra-Castillo, M Barrientos-Pérez, H Rivero-Escalante, O Flores-Caloca, R Calzada-León, C C Rosas-Guerra, E Koledova, E Chiquete and 1 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of endocrinological investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01555528 (Easypod Connect), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01555528 completednot on this map

Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Mexico

TypeobservationalSponsorMerck KGaA, Darmstadt, GermanyRan2012 to 2015Enrolled193ConditionsGrowth DisordersArmseasypod™
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

A Blanco-LópezHospital Ángeles Interlomas and Hospital Español, Mexico City, Mexico.
C Antillón-FerreiraHospital Español, Mexico City, Mexico.
E Saavedra-CastilloHospital de la Oca, Monterrey, Nuevo León, Mexico.
M Barrientos-PérezHospital Ángeles, Puebla, Puebla, Mexico.
H Rivero-EscalantePrivate Practice, Cancún, Quintana Roo, Mexico.
O Flores-CalocaHospital Zambrano Hellion, Monterrey, Nuevo León, Mexico.
R Calzada-LeónServicio de Endocrinología, Instituto Nacional de Pediatría, Mexico City, Mexico.
C C Rosas-GuerraMerck Biopharma Distribution S.A. de C.V, Naucalpan de Juárez, Mexico.
E KoledovaMerck Healthcare KGaA, Darmstadt, Germany.
E ChiqueteDepartamento de Neurología y Psiquiatría, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Delegacion Tlalpan, C.P. 14080, Ciudad de Mexico, México. erwinchiquete@hotmail.com.
A Ayala-EstradaServicio de Pediatría, Hospital ISSEMyM, Toluca, Estado de México, México. dr_arturo78@hotmail.com.

Funding

Merck KGaA NCT01555528
6 · The paper itself

Abstract

backgroundAssessing adherence to growth hormone (GH) is challenging. The Easypod™ connect device delivers pre-set doses of recombinant human GH (r-hGH) and stores a digital record of adherence that can be shared with healthcare provider. We assessed adherence to r-hGH delivered with Easypod™ according to the approved pediatric indications for r-hGH: growth hormone deficiency (GHD), born small for gestational age (SGA) who failed to show catch-up growth and Turner syndrome (TS).

methodsECOS (NCT01555528) was a multicenter (24 countries), 5-year, longitudinal, observational study, which aimed to evaluate country-specific adherence to r-hGH therapy prescribed via the Easypod™ electronic injection device. The primary endpoint was yearly adherence. Secondary endpoints were height velocity, height velocity standard deviation scores (SDS), height, height SDS and IGF-1 concentrations. Clinical and auxological data were obtained from medical records and adherence from Easypod™ logs.

resultsThis study included 147 Easypod™-naïve Mexican children assessed during 3 years (mean age: 9.96 ± 3.41 years, 56.8% boys, mean height SDS at baseline: - 2.17 ± 0.97): 118 with GHD, 24 SGA and 5 with TS. A total of 105 (71.4%) patients were GH naïve. Overall median adherence was > 90% over the first year of treatment and > 80% at 3 years. Adherence was not different by r-hGH indication or between GH-naïve or experienced patients. At 1-year follow-up, mean change in height SDS was 0.57 ± 0.34, whereas mean height velocity SDS was 2.85 ± 2.51. In all, 84.7% patients had normal IGF-1 concentrations at 1-year follow-up. Adherence was associated with change in height SDS (r = 0.239, p = 0.005) and height velocity SDS (r = 0.194, p = 0.027).

conclusionAdherence rates with the Easypod™ device are high and maintained over time in GHD, SGA and TS Easypod™-naïve Mexican patients. High adherence is associated with better outcomes. Easypod™ assists physicians in monitoring adherence to r-hGH.

Indexed as

Drug MonitoringAdolescentChildDwarfism, PituitaryFemaleGrowth DisordersHormone Replacement TherapyHuman Growth HormoneHumansInfant, NewbornInfant, Small for Gestational AgeLongitudinal StudiesMaleMexicoRecombinant ProteinsTurner SyndromeHuman Growth HormoneRecombinant ProteinsAdherenceAuto-injectorDeviceGrowth hormoneSomatotropin

Identifiers

PMID32239476
PMCPMC7481146

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.