Ease of use and preference for a new disposable self-injection pen compared with a reusable pen for administering recombinant human growth hormone

A multicenter, 2-Month, single-arm, open-label clinical trial in patient-caregiver dyads

Judith Hey-Hadavi, Andreas Pleil, Larry C. Deeb, John Fuqua, Lawrence A. Silverman, Barry Reiner, Ron Newfield, Natasa Rajicic, Michael P. Wajnrajch, Jose F. Cara

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background: Improved ease of use of drug-delivery devices may enhance compliance. Development of an easier-to-use device for administration of recombinant human growth hormone (rhGH) may thus be beneficial for patients and their caregivers.Objective: This study compared ease of use and preference for a new disposable rhGH injection pen relative to previous experience with the currently available reusable pen in standard practice. Both pens deliver the same formulation of rhGH.Methods: This multicenter, single-arm, open-label study assessed ease of use and preference for the 2 injection pens in patient-caregiver dyads. Eligible children were aged 8 through 18 years, were currently being treated with rhGH, and had been compliant with use of the current reusable pen for ≥3 months before study entry. A validated self-reported Injection Pen Assessment Questionnaire was administered twice during the study-at baseline (to assess perceptions of the reusable pen) and after 2 months of use of the new disposable pen-to assess ease of use of the individual pens (rated on a 5-point Likert-type scale), the comparative ease of use of the 2 pens, and pen preference. The primary end point was the proportion of dyads who rated the new pen as no different or easier to use than the current pen. Regardless of treatment or suspected causal relationship to the investigational product, all observed or volun- teered adverse events (AEs) were recorded and rated as mild, moderate, or severe.Results: Of 137 screened dyads, 136 (91 boys, 45 girls) were included in the safety population and 133 were included in the efficacy population. The children had a mean age of 12.3 years, a mean weight of 42.2 kg, a mean height of 145.9 cm, and a mean body mass index of 19.3 kg/m2; 84.6% of the children were white. The majority (82.4%) of adult dyad members were subjects' mothers. The adult dyad members were more likely than the child members to be responsible for preparing the injection (82.0%) and administering the injection (72.9%). Overall, 73.7% of dyads rated the new disposable pen no different or easier to use than the reusable pen (95% CI, 66.2%-81.2%), and 65.2% rated the disposable pen no different or preferable to the reusable pen (95% CI, 57.0%-73.3%). Overall, 60 all-causality AEs occurred in 28 subjects (20.6%), most of them (93.3%) either mild or moderate in intensity. Eight device-related AEs occurred in 7 subjects (5.1%) (injection-site hematoma in 3 and injection-site pain in 5). The most common AEs were headache (7 events), injection-site pain (5), upper respiratory tract infection (4), and pyrexia (4). No deaths or serious AEs were reported.Conclusions: Nearly three quarters of patients and caregivers reported that the new disposable pen was no Accepted for publication October 1, 2010. different or easier to use than the reusable pen, and nearly two thirds preferred the disposable pen. No safety concerns were identified. The findings suggest that the improvements in the new pen were recognized by patients and caregivers.

Original languageEnglish
Pages (from-to)2036-2047
Number of pages12
JournalClinical Therapeutics
Volume32
Issue number12
DOIs
StatePublished - Nov 2010

Fingerprint

Human Growth Hormone
Caregivers
Growth Hormone
Clinical Trials
Injections
Equipment and Supplies
Safety
Pain
Respiratory Tract Infections
Causality
Hematoma
Population
Compliance
Headache
Publications
Body Mass Index
Fever
Mothers
Weights and Measures
Pharmaceutical Preparations

Keywords

  • Dyad
  • Genotropin
  • Growth hormone
  • Pen
  • Preference
  • Somatotropin

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Ease of use and preference for a new disposable self-injection pen compared with a reusable pen for administering recombinant human growth hormone : A multicenter, 2-Month, single-arm, open-label clinical trial in patient-caregiver dyads. / Hey-Hadavi, Judith; Pleil, Andreas; Deeb, Larry C.; Fuqua, John; Silverman, Lawrence A.; Reiner, Barry; Newfield, Ron; Rajicic, Natasa; Wajnrajch, Michael P.; Cara, Jose F.

In: Clinical Therapeutics, Vol. 32, No. 12, 11.2010, p. 2036-2047.

Research output: Contribution to journalArticle

Hey-Hadavi, Judith ; Pleil, Andreas ; Deeb, Larry C. ; Fuqua, John ; Silverman, Lawrence A. ; Reiner, Barry ; Newfield, Ron ; Rajicic, Natasa ; Wajnrajch, Michael P. ; Cara, Jose F. / Ease of use and preference for a new disposable self-injection pen compared with a reusable pen for administering recombinant human growth hormone : A multicenter, 2-Month, single-arm, open-label clinical trial in patient-caregiver dyads. In: Clinical Therapeutics. 2010 ; Vol. 32, No. 12. pp. 2036-2047.
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abstract = "Background: Improved ease of use of drug-delivery devices may enhance compliance. Development of an easier-to-use device for administration of recombinant human growth hormone (rhGH) may thus be beneficial for patients and their caregivers.Objective: This study compared ease of use and preference for a new disposable rhGH injection pen relative to previous experience with the currently available reusable pen in standard practice. Both pens deliver the same formulation of rhGH.Methods: This multicenter, single-arm, open-label study assessed ease of use and preference for the 2 injection pens in patient-caregiver dyads. Eligible children were aged 8 through 18 years, were currently being treated with rhGH, and had been compliant with use of the current reusable pen for ≥3 months before study entry. A validated self-reported Injection Pen Assessment Questionnaire was administered twice during the study-at baseline (to assess perceptions of the reusable pen) and after 2 months of use of the new disposable pen-to assess ease of use of the individual pens (rated on a 5-point Likert-type scale), the comparative ease of use of the 2 pens, and pen preference. The primary end point was the proportion of dyads who rated the new pen as no different or easier to use than the current pen. Regardless of treatment or suspected causal relationship to the investigational product, all observed or volun- teered adverse events (AEs) were recorded and rated as mild, moderate, or severe.Results: Of 137 screened dyads, 136 (91 boys, 45 girls) were included in the safety population and 133 were included in the efficacy population. The children had a mean age of 12.3 years, a mean weight of 42.2 kg, a mean height of 145.9 cm, and a mean body mass index of 19.3 kg/m2; 84.6{\%} of the children were white. The majority (82.4{\%}) of adult dyad members were subjects' mothers. The adult dyad members were more likely than the child members to be responsible for preparing the injection (82.0{\%}) and administering the injection (72.9{\%}). Overall, 73.7{\%} of dyads rated the new disposable pen no different or easier to use than the reusable pen (95{\%} CI, 66.2{\%}-81.2{\%}), and 65.2{\%} rated the disposable pen no different or preferable to the reusable pen (95{\%} CI, 57.0{\%}-73.3{\%}). Overall, 60 all-causality AEs occurred in 28 subjects (20.6{\%}), most of them (93.3{\%}) either mild or moderate in intensity. Eight device-related AEs occurred in 7 subjects (5.1{\%}) (injection-site hematoma in 3 and injection-site pain in 5). The most common AEs were headache (7 events), injection-site pain (5), upper respiratory tract infection (4), and pyrexia (4). No deaths or serious AEs were reported.Conclusions: Nearly three quarters of patients and caregivers reported that the new disposable pen was no Accepted for publication October 1, 2010. different or easier to use than the reusable pen, and nearly two thirds preferred the disposable pen. No safety concerns were identified. The findings suggest that the improvements in the new pen were recognized by patients and caregivers.",
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TY - JOUR

T1 - Ease of use and preference for a new disposable self-injection pen compared with a reusable pen for administering recombinant human growth hormone

T2 - A multicenter, 2-Month, single-arm, open-label clinical trial in patient-caregiver dyads

AU - Hey-Hadavi, Judith

AU - Pleil, Andreas

AU - Deeb, Larry C.

AU - Fuqua, John

AU - Silverman, Lawrence A.

AU - Reiner, Barry

AU - Newfield, Ron

AU - Rajicic, Natasa

AU - Wajnrajch, Michael P.

AU - Cara, Jose F.

PY - 2010/11

Y1 - 2010/11

N2 - Background: Improved ease of use of drug-delivery devices may enhance compliance. Development of an easier-to-use device for administration of recombinant human growth hormone (rhGH) may thus be beneficial for patients and their caregivers.Objective: This study compared ease of use and preference for a new disposable rhGH injection pen relative to previous experience with the currently available reusable pen in standard practice. Both pens deliver the same formulation of rhGH.Methods: This multicenter, single-arm, open-label study assessed ease of use and preference for the 2 injection pens in patient-caregiver dyads. Eligible children were aged 8 through 18 years, were currently being treated with rhGH, and had been compliant with use of the current reusable pen for ≥3 months before study entry. A validated self-reported Injection Pen Assessment Questionnaire was administered twice during the study-at baseline (to assess perceptions of the reusable pen) and after 2 months of use of the new disposable pen-to assess ease of use of the individual pens (rated on a 5-point Likert-type scale), the comparative ease of use of the 2 pens, and pen preference. The primary end point was the proportion of dyads who rated the new pen as no different or easier to use than the current pen. Regardless of treatment or suspected causal relationship to the investigational product, all observed or volun- teered adverse events (AEs) were recorded and rated as mild, moderate, or severe.Results: Of 137 screened dyads, 136 (91 boys, 45 girls) were included in the safety population and 133 were included in the efficacy population. The children had a mean age of 12.3 years, a mean weight of 42.2 kg, a mean height of 145.9 cm, and a mean body mass index of 19.3 kg/m2; 84.6% of the children were white. The majority (82.4%) of adult dyad members were subjects' mothers. The adult dyad members were more likely than the child members to be responsible for preparing the injection (82.0%) and administering the injection (72.9%). Overall, 73.7% of dyads rated the new disposable pen no different or easier to use than the reusable pen (95% CI, 66.2%-81.2%), and 65.2% rated the disposable pen no different or preferable to the reusable pen (95% CI, 57.0%-73.3%). Overall, 60 all-causality AEs occurred in 28 subjects (20.6%), most of them (93.3%) either mild or moderate in intensity. Eight device-related AEs occurred in 7 subjects (5.1%) (injection-site hematoma in 3 and injection-site pain in 5). The most common AEs were headache (7 events), injection-site pain (5), upper respiratory tract infection (4), and pyrexia (4). No deaths or serious AEs were reported.Conclusions: Nearly three quarters of patients and caregivers reported that the new disposable pen was no Accepted for publication October 1, 2010. different or easier to use than the reusable pen, and nearly two thirds preferred the disposable pen. No safety concerns were identified. The findings suggest that the improvements in the new pen were recognized by patients and caregivers.

AB - Background: Improved ease of use of drug-delivery devices may enhance compliance. Development of an easier-to-use device for administration of recombinant human growth hormone (rhGH) may thus be beneficial for patients and their caregivers.Objective: This study compared ease of use and preference for a new disposable rhGH injection pen relative to previous experience with the currently available reusable pen in standard practice. Both pens deliver the same formulation of rhGH.Methods: This multicenter, single-arm, open-label study assessed ease of use and preference for the 2 injection pens in patient-caregiver dyads. Eligible children were aged 8 through 18 years, were currently being treated with rhGH, and had been compliant with use of the current reusable pen for ≥3 months before study entry. A validated self-reported Injection Pen Assessment Questionnaire was administered twice during the study-at baseline (to assess perceptions of the reusable pen) and after 2 months of use of the new disposable pen-to assess ease of use of the individual pens (rated on a 5-point Likert-type scale), the comparative ease of use of the 2 pens, and pen preference. The primary end point was the proportion of dyads who rated the new pen as no different or easier to use than the current pen. Regardless of treatment or suspected causal relationship to the investigational product, all observed or volun- teered adverse events (AEs) were recorded and rated as mild, moderate, or severe.Results: Of 137 screened dyads, 136 (91 boys, 45 girls) were included in the safety population and 133 were included in the efficacy population. The children had a mean age of 12.3 years, a mean weight of 42.2 kg, a mean height of 145.9 cm, and a mean body mass index of 19.3 kg/m2; 84.6% of the children were white. The majority (82.4%) of adult dyad members were subjects' mothers. The adult dyad members were more likely than the child members to be responsible for preparing the injection (82.0%) and administering the injection (72.9%). Overall, 73.7% of dyads rated the new disposable pen no different or easier to use than the reusable pen (95% CI, 66.2%-81.2%), and 65.2% rated the disposable pen no different or preferable to the reusable pen (95% CI, 57.0%-73.3%). Overall, 60 all-causality AEs occurred in 28 subjects (20.6%), most of them (93.3%) either mild or moderate in intensity. Eight device-related AEs occurred in 7 subjects (5.1%) (injection-site hematoma in 3 and injection-site pain in 5). The most common AEs were headache (7 events), injection-site pain (5), upper respiratory tract infection (4), and pyrexia (4). No deaths or serious AEs were reported.Conclusions: Nearly three quarters of patients and caregivers reported that the new disposable pen was no Accepted for publication October 1, 2010. different or easier to use than the reusable pen, and nearly two thirds preferred the disposable pen. No safety concerns were identified. The findings suggest that the improvements in the new pen were recognized by patients and caregivers.

KW - Dyad

KW - Genotropin

KW - Growth hormone

KW - Pen

KW - Preference

KW - Somatotropin

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