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Tytuł:
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Connected health for growth hormone treatment research and clinical practice: learnings from different sources of real-world evidence (RWE)-large electronically collected datasets, surveillance studies and individual patients' cases.
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Autorzy:
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Boman N; Paediatric Endocrinology, Children's Hospital, University of Helsinki and Helsinki University Central Hospital, Stenbackinkatu 11, PO BOX 281, 00029, Helsinki, Finland. .
Fernandez-Luque L; Adhera Health Inc., Palo Alto, CA, USA.
Koledova E; Global Medical Affairs Cardiometabolic and Endocrinology, Merck KGaA, Darmstadt, Germany.
Kause M; Medical Department, Merck Oy Finland (an affiliate of Merck KGaA, Darmstadt, Germany), Espoo, Finland.
Lapatto R; Paediatric Endocrinology, Children's Hospital, University of Helsinki and Helsinki University Central Hospital, Stenbackinkatu 11, PO BOX 281, 00029, Helsinki, Finland.
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Źródło:
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BMC medical informatics and decision making [BMC Med Inform Decis Mak] 2021 Apr 26; Vol. 21 (1), pp. 136. Date of Electronic Publication: 2021 Apr 26.
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Typ publikacji:
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Journal Article; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Original Publication: London : BioMed Central, [2001-
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MeSH Terms:
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Human Growth Hormone*
Adolescent ; Child ; Female ; Growth Disorders ; Growth Hormone ; Humans ; Male ; Patient Compliance
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References:
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Contributed Indexing:
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Keywords: Adherence monitoring; EHealth; Growth outcomes; Observational study
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Substance Nomenclature:
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12629-01-5 (Human Growth Hormone)
9002-72-6 (Growth Hormone)
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Entry Date(s):
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Date Created: 20210427 Date Completed: 20210607 Latest Revision: 20220531
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Update Code:
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20240104
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PubMed Central ID:
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PMC8074467
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DOI:
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10.1186/s12911-021-01491-0
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PMID:
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33902570
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Background: A range of factors can reduce the effectiveness of treatment prescribed for the long-term management of chronic health conditions, such as growth disorders. In particular, prescription medications may not achieve the positive outcomes expected because approximately half of patients adhere poorly to the prescribed treatment regimen.
Methods: Adherence to treatment has previously been assessed using relatively unreliable subjective methods, such as patient self-reporting during clinical follow-up, or counting prescriptions filled or vials returned by patients. Here, we report on a new approach, the use of electronically recorded objective evidence of date, time, and dose taken which was obtained through a comprehensive eHealth ecosystem, based around the easypod™ electromechanical auto-injection device and web-based connect software. The benefits of this eHealth approach are also illustrated here by two case studies, selected from the Finnish cohort of the easypod™ Connect Observational Study (ECOS), a 5-year, open-label, observational study that enrolled children from 24 countries who were being treated with growth hormone (GH) via the auto-injection device.
Results: Analyses of data from 9314 records from the easypod™ connect database showed that, at each time point studied, a significantly greater proportion of female patients had high adherence (≥ 85%) than male patients (2849/3867 [74%] vs 3879/5447 [71%]; P < 0.001). Furthermore, more of the younger patients (< 10 years for girls, < 12 years for boys) were in the high adherence range (P < 0.001). However, recursive partitioning of data from ECOS identified subgroups with lower adherence to GH treatment ‒ children who performed the majority of injections themselves at an early age (~ 8 years) and teenagers starting treatment aged ≥ 14 years.
Conclusions: The data and case studies presented herein illustrate the importance of adherence to GH therapy and how good growth outcomes can be achieved by following treatment as described. They also show how the device, software, and database ecosystem can complement normal clinical follow-up by providing HCPs with reliable information about patient adherence between visits and also providing researchers with real-world evidence of adherence and growth outcomes across a large population of patients with growth disorders treated with GH via the easypod™ device.
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