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Accepted for/Published in: JMIR mHealth and uHealth

Date Submitted: Aug 4, 2021
Open Peer Review Period: Aug 4, 2021 - Sep 14, 2021
Date Accepted: Nov 27, 2021
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Adherence to Growth Hormone Treatment Using a Connected Device in Latin America: Real-World Exploratory Descriptive Analysis Study

Assefi A, van Dommelen P, Arnaud L, Otero C, Fernandez-Luque L, Koledova E, Calliari LE

Adherence to Growth Hormone Treatment Using a Connected Device in Latin America: Real-World Exploratory Descriptive Analysis Study

JMIR Mhealth Uhealth 2022;10(1):e32626

DOI: 10.2196/32626

PMID: 35049518

PMCID: 8814928

Adherence to Growth Hormone Treatment in Latin America: Real-World Data Analysis of Over 2 Million Injections Using a Connected Device

  • Aria Assefi; 
  • Paula van Dommelen; 
  • Lilian Arnaud; 
  • Carlos Otero; 
  • Luis Fernandez-Luque; 
  • Ekaterina Koledova; 
  • Luis Eduardo Calliari

ABSTRACT

Background:

Recombinant human growth hormone (r-hGH) therapy is an effective treatment in treating children with growth disorders. However, poor outcomes are often associated with suboptimal adherence to treatment.

Objective:

The easypod™ connected injection device records and transmits injection settings and dose data from patients receiving r-hGH. In this study, we evaluated adherence to r-hGH treatment, and associated growth outcomes, in Latin American (LATAM) patients.

Methods:

Adherence and growth data from patients aged 2-18 years from 12 LATAM countries were analyzed. Adherence data were available for 6,207 patients with 2,449,879 injections, and growth data were available for 497 patients with 2,232 measurements. Adherence was categorized, based on mg of r-hGH injected versus mg of r-hGH prescribed, as high (≥85%), intermediate (>56%-84%), or low (≤56%). Transmission frequency was categorized as high (≥1 per 3 months) or low (<1 per 3 months). Chi-square tests were applied to study the effect of pubertal status at treatment start and sex on high adherence and to test differences in frequency transmission between the three adherence levels. Multi-level linear regression techniques were applied to study the effect of adherence on observed ∆HSDS.

Results:

Overall, 68%, 25%, and 7% of patients had high, intermediate, and low adherence, respectively. Pubertal status at treatment start and sex did not have a significant effect on high adherence. Significant differences were found in the proportion of patients with high transmission frequency between high (59%), intermediate (46%), and low (35%) adherence groups (P<.001). Adherence level had a significant effect on ∆HSDS (P=.006). Mean catch-up growth between 0-24 months was +0.65 SD overall (+0.52 SD in patients with low/intermediate monthly adherence and +0.69 in patients with high monthly adherence). This difference translated into 1.1 cm greater catch-up growth with high adherence.

Conclusions:

The data extracted from the easypod™ connect ecosystem showed high adherence to r-hGH treatment in LATAM patients, with positive growth outcomes, indicating the importance of connected device solutions for r-hGH treatment in patients with growth disorders.


 Citation

Please cite as:

Assefi A, van Dommelen P, Arnaud L, Otero C, Fernandez-Luque L, Koledova E, Calliari LE

Adherence to Growth Hormone Treatment Using a Connected Device in Latin America: Real-World Exploratory Descriptive Analysis Study

JMIR Mhealth Uhealth 2022;10(1):e32626

DOI: 10.2196/32626

PMID: 35049518

PMCID: 8814928

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