Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial

Ji-Eun Lee,1 Se Young Kim,2 Jae-Ho Yoo,3 Il Tae Hwang,4 Jung Sub Lim,5 Kyung Hee Yi,6 Young-Jun Rhie,7 Gyung Min Lee,8 Hyo-Kyoung Nam,9 Hyun Wook Chae,10 Eun Young Kim,11 Chong Kun Cheon,12 Jieun Lee,13 Young Suk Shim,14 YuJin Lee,15 Eun Young Kim,15 Jin Soon Hwang16 1Department of Pediatrics, Inha...

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Main Authors: Lee JE, Kim SY, Yoo JH, Hwang IT, Lim JS, Yi KH, Rhie YJ, Lee GM, Nam HK, Chae HW, Kim EY, Cheon CK, Lee J, Shim YS, Lee Y, Hwang JS
Format: Article
Language:English
Published: Dove Medical Press 2019-12-01
Series:Patient Preference and Adherence
Subjects:
Online Access:https://www.dovepress.com/ease-of-use-preference-and-safety-of-the-recombinant-human-growth-horm-peer-reviewed-article-PPA
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author Lee JE
Kim SY
Yoo JH
Hwang IT
Lim JS
Yi KH
Rhie YJ
Lee GM
Nam HK
Chae HW
Kim EY
Cheon CK
Lee J
Shim YS
Lee Y
Kim EY
Hwang JS
author_facet Lee JE
Kim SY
Yoo JH
Hwang IT
Lim JS
Yi KH
Rhie YJ
Lee GM
Nam HK
Chae HW
Kim EY
Cheon CK
Lee J
Shim YS
Lee Y
Kim EY
Hwang JS
author_sort Lee JE
collection DOAJ
description Ji-Eun Lee,1 Se Young Kim,2 Jae-Ho Yoo,3 Il Tae Hwang,4 Jung Sub Lim,5 Kyung Hee Yi,6 Young-Jun Rhie,7 Gyung Min Lee,8 Hyo-Kyoung Nam,9 Hyun Wook Chae,10 Eun Young Kim,11 Chong Kun Cheon,12 Jieun Lee,13 Young Suk Shim,14 YuJin Lee,15 Eun Young Kim,15 Jin Soon Hwang16 1Department of Pediatrics, Inha University Hospital, Inha University Graduate School of Medicine, Incheon, Republic of Korea; 2Department of Pediatrics & Adolescent Medicine, Bundang Jeseang General Hospital, Daejin Medical Center, Seongnam, Republic of Korea; 3Department of Pediatrics, Dong-a University Hospital, Dong-a University College of Medicine, Busan, Republic of Korea; 4Department of Pediatrics, Kangdong Sacred Heart Hospital, Hallym University, College of Medicine, Seoul, Republic of Korea; 5Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea; 6Department of Pediatrics, Wonkwang University Sanbon Medical Center, Gunpo, Republic of Korea; 7Department of Pediatrics, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea; 8Department of Pediatrics, Konyang University Hospital, Daejeon, Republic of Korea; 9Department of Pediatrics, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea; 10Department of Pediatrics, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea; 11Department of Pediatrics, Chosun University Hospital, Chosun University School of Medicine, Gwangju, Republic of Korea; 12Department of Pediatrics, Pusan National University Children’s Hospital, Pusan National University School of Medicine, Yangsan, Republic of Korea; 13Department of Pediatrics, Inje University Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Republic of Korea; 14Department of Pediatrics & Adolescent Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea; 15Life Sciences, LG Chem, Ltd., Seoul, Republic of Korea; 16Department of Pediatrics & Adolescent Medicine, Ajou University Hospital, Ajou University School of Medicine, Suwon, Republic of KoreaCorrespondence: Jin Soon HwangDepartment of Pediatrics & Adolescent Medicine, Ajou University Hospital, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 16499, Republic of KoreaTel +82 31 219 5166Fax +82 31 219 5169Email pedhwang@ajou.ac.krPurpose: To assess the usability and safety of the disposable pen compared to those of reusable devices in patients receiving recombinant human growth hormone (rhGH) treatment.Patients and methods: This study was a multicenter, single-arm, open-label, switch-over, prospective, Phase IV trial. After screening, eligible patients who were previously treated with rhGH using a reusable device were enrolled to receive treatment with the disposable pen for 8 weeks. The ease of use, preference, and tolerability of the disposable pen compared to those of the reusable device were assessed by the subjects and/or their caregivers using a questionnaire. Adverse events were evaluated by the investigators.Results: Of 116 subjects enrolled in this study, 115 received treatment with the disposable pen and 109 completed the study. The mean age of the subjects was 9.4 years. Compared to the previous reusable device, the disposable pen was assessed as significantly easier to use (mean value 7.88, 95% confidence interval (CI) [7.45–8.30] on a numerical scale ranging from 0 (far less easy) to 10 (far easier)). Furthermore, the percentage of subjects who preferred the disposable pen to the previously used reusable device was 75.7% (95% CI [67.6%–83.8%]). The percentages of subjects who rated pain and discomfort at the injection site as “not at all” were higher after using the disposable pen compared to the reusable device. No specific safety concerns were identified.Conclusion: The disposable pen is easier to use than the reusable devices and is preferred by approximately 75% of patients receiving rhGH treatment. Moreover, the disposable pen is safe and acceptable. Therefore, it could be a good alternative to reusable devices. The disposable pen is expected to provide benefits to patients receiving rhGH treatment.Clinicaltrials.gov identifier: NCT03015909.Keywords: growth hormone, disposable equipment, patient preference, usability, safety
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spelling doaj.art-2b83f597f313459aa1e22ee71196abd22022-12-22T03:44:38ZengDove Medical PressPatient Preference and Adherence1177-889X2019-12-01Volume 132195220550623Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV TrialLee JEKim SYYoo JHHwang ITLim JSYi KHRhie YJLee GMNam HKChae HWKim EYCheon CKLee JShim YSLee YKim EYHwang JSJi-Eun Lee,1 Se Young Kim,2 Jae-Ho Yoo,3 Il Tae Hwang,4 Jung Sub Lim,5 Kyung Hee Yi,6 Young-Jun Rhie,7 Gyung Min Lee,8 Hyo-Kyoung Nam,9 Hyun Wook Chae,10 Eun Young Kim,11 Chong Kun Cheon,12 Jieun Lee,13 Young Suk Shim,14 YuJin Lee,15 Eun Young Kim,15 Jin Soon Hwang16 1Department of Pediatrics, Inha University Hospital, Inha University Graduate School of Medicine, Incheon, Republic of Korea; 2Department of Pediatrics & Adolescent Medicine, Bundang Jeseang General Hospital, Daejin Medical Center, Seongnam, Republic of Korea; 3Department of Pediatrics, Dong-a University Hospital, Dong-a University College of Medicine, Busan, Republic of Korea; 4Department of Pediatrics, Kangdong Sacred Heart Hospital, Hallym University, College of Medicine, Seoul, Republic of Korea; 5Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea; 6Department of Pediatrics, Wonkwang University Sanbon Medical Center, Gunpo, Republic of Korea; 7Department of Pediatrics, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea; 8Department of Pediatrics, Konyang University Hospital, Daejeon, Republic of Korea; 9Department of Pediatrics, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea; 10Department of Pediatrics, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea; 11Department of Pediatrics, Chosun University Hospital, Chosun University School of Medicine, Gwangju, Republic of Korea; 12Department of Pediatrics, Pusan National University Children’s Hospital, Pusan National University School of Medicine, Yangsan, Republic of Korea; 13Department of Pediatrics, Inje University Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Republic of Korea; 14Department of Pediatrics & Adolescent Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea; 15Life Sciences, LG Chem, Ltd., Seoul, Republic of Korea; 16Department of Pediatrics & Adolescent Medicine, Ajou University Hospital, Ajou University School of Medicine, Suwon, Republic of KoreaCorrespondence: Jin Soon HwangDepartment of Pediatrics & Adolescent Medicine, Ajou University Hospital, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 16499, Republic of KoreaTel +82 31 219 5166Fax +82 31 219 5169Email pedhwang@ajou.ac.krPurpose: To assess the usability and safety of the disposable pen compared to those of reusable devices in patients receiving recombinant human growth hormone (rhGH) treatment.Patients and methods: This study was a multicenter, single-arm, open-label, switch-over, prospective, Phase IV trial. After screening, eligible patients who were previously treated with rhGH using a reusable device were enrolled to receive treatment with the disposable pen for 8 weeks. The ease of use, preference, and tolerability of the disposable pen compared to those of the reusable device were assessed by the subjects and/or their caregivers using a questionnaire. Adverse events were evaluated by the investigators.Results: Of 116 subjects enrolled in this study, 115 received treatment with the disposable pen and 109 completed the study. The mean age of the subjects was 9.4 years. Compared to the previous reusable device, the disposable pen was assessed as significantly easier to use (mean value 7.88, 95% confidence interval (CI) [7.45–8.30] on a numerical scale ranging from 0 (far less easy) to 10 (far easier)). Furthermore, the percentage of subjects who preferred the disposable pen to the previously used reusable device was 75.7% (95% CI [67.6%–83.8%]). The percentages of subjects who rated pain and discomfort at the injection site as “not at all” were higher after using the disposable pen compared to the reusable device. No specific safety concerns were identified.Conclusion: The disposable pen is easier to use than the reusable devices and is preferred by approximately 75% of patients receiving rhGH treatment. Moreover, the disposable pen is safe and acceptable. Therefore, it could be a good alternative to reusable devices. The disposable pen is expected to provide benefits to patients receiving rhGH treatment.Clinicaltrials.gov identifier: NCT03015909.Keywords: growth hormone, disposable equipment, patient preference, usability, safetyhttps://www.dovepress.com/ease-of-use-preference-and-safety-of-the-recombinant-human-growth-horm-peer-reviewed-article-PPAgrowth hormonedisposable equipmentpatient preferenceusabilitysafety
spellingShingle Lee JE
Kim SY
Yoo JH
Hwang IT
Lim JS
Yi KH
Rhie YJ
Lee GM
Nam HK
Chae HW
Kim EY
Cheon CK
Lee J
Shim YS
Lee Y
Kim EY
Hwang JS
Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial
Patient Preference and Adherence
growth hormone
disposable equipment
patient preference
usability
safety
title Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial
title_full Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial
title_fullStr Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial
title_full_unstemmed Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial
title_short Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial
title_sort ease of use preference and safety of the recombinant human growth hormone disposable pen compared with the reusable device a multicenter single arm open label switch over prospective phase iv trial
topic growth hormone
disposable equipment
patient preference
usability
safety
url https://www.dovepress.com/ease-of-use-preference-and-safety-of-the-recombinant-human-growth-horm-peer-reviewed-article-PPA
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