Psychological responses to the needle-free Medi-Jector® or the multidose Disetronic® injection pen in human growth hormone therapy
The aim of the study was to test the hypothesis that daily administration of growth hormone using the Medi‐Jector® results in fewer adverse psychological responses than needle injection with a multidose injection pen. The Medi‐Jector is a needle‐free injection device that can deliver growth hormone...
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Published in: | Acta Paediatrica Vol. 87; no. 2; pp. 154 - 158 |
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Main Authors: | , , , , , |
Format: | Journal Article |
Language: | English |
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Oxford, UK
Blackwell Publishing Ltd
01-02-1998
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Abstract | The aim of the study was to test the hypothesis that daily administration of growth hormone using the Medi‐Jector® results in fewer adverse psychological responses than needle injection with a multidose injection pen. The Medi‐Jector is a needle‐free injection device that can deliver growth hormone subcutaneously through jet injection. The group studied consisted of 18 children aged 10 y or over who were participating in a study of the bioequivalence and bioequipotence of the administration of growth hormone through jet injection or needle injection. Previously, all subjects had received growth hormone therapy with commercially available multidose injection pens. The study was designed as a prospective, randomized, two‐period cross‐over trial. A questionnaire was used to assess psychological responses such as non‐compliance, opinion on ease of preparation, affective responses to administration and local side‐effects, as well as overall preference. In addition, the subjects kept a diary during the study. The subjects found the Medi‐Jector less offputting (p < 0:01), less painful with respect to both frequency (p <0.04) and intensity (p < 0.01) and less unpleasant (p < 0.05) than a multidose injection pen with a 28G needle (p <0.01). No difference in compliance was detected. Most subjects preferred the Medi‐Jector for future use (p < 0.05). The mean score on a 1–10 point scale (10 is excellent) was 7.9 (SD 1.4) for the Medi‐Jector and 6.8 (SD2.3) for the multidose injection pen (p <0.08). The prevalence of visible bruises each day was higher (p < 0.01) with the Medi‐Jector (2.5, SD 2.1) than with the multidose injection pen (0.7, SD 1.1), but children showed indifferent affective responses to bruising. Thirteen out of 18 subjects decided to continue therapy with the Medi‐Jector (p < 0.06). It is concluded that use of the Medi‐Jector in growth hormone therapy tends to lead to fewer adverse psychological responses than a multidose injection pen with 28G needles. |
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AbstractList | The aim of the study was to test the hypothesis that daily administration of growth hormone using the Medi‐Jector® results in fewer adverse psychological responses than needle injection with a multidose injection pen. The Medi‐Jector is a needle‐free injection device that can deliver growth hormone subcutaneously through jet injection. The group studied consisted of 18 children aged 10 y or over who were participating in a study of the bioequivalence and bioequipotence of the administration of growth hormone through jet injection or needle injection. Previously, all subjects had received growth hormone therapy with commercially available multidose injection pens. The study was designed as a prospective, randomized, two‐period cross‐over trial. A questionnaire was used to assess psychological responses such as non‐compliance, opinion on ease of preparation, affective responses to administration and local side‐effects, as well as overall preference. In addition, the subjects kept a diary during the study. The subjects found the Medi‐Jector less offputting (
p
< 0:01), less painful with respect to both frequency (
p
<0.04) and intensity (
p
< 0.01) and less unpleasant (
p
< 0.05) than a multidose injection pen with a 28G needle (
p
<0.01). No difference in compliance was detected. Most subjects preferred the Medi‐Jector for future use (
p
< 0.05). The mean score on a 1–10 point scale (10 is excellent) was 7.9 (SD 1.4) for the Medi‐Jector and 6.8 (SD2.3) for the multidose injection pen (
p
<0.08). The prevalence of visible bruises each day was higher (
p
< 0.01) with the Medi‐Jector (2.5, SD 2.1) than with the multidose injection pen (0.7, SD 1.1), but children showed indifferent affective responses to bruising. Thirteen out of 18 subjects decided to continue therapy with the Medi‐Jector (
p
< 0.06). It is concluded that use of the Medi‐Jector in growth hormone therapy tends to lead to fewer adverse psychological responses than a multidose injection pen with 28G needles. The aim of the study was to test the hypothesis that daily administration of growth hormone using the Medi‐Jector® results in fewer adverse psychological responses than needle injection with a multidose injection pen. The Medi‐Jector is a needle‐free injection device that can deliver growth hormone subcutaneously through jet injection. The group studied consisted of 18 children aged 10 y or over who were participating in a study of the bioequivalence and bioequipotence of the administration of growth hormone through jet injection or needle injection. Previously, all subjects had received growth hormone therapy with commercially available multidose injection pens. The study was designed as a prospective, randomized, two‐period cross‐over trial. A questionnaire was used to assess psychological responses such as non‐compliance, opinion on ease of preparation, affective responses to administration and local side‐effects, as well as overall preference. In addition, the subjects kept a diary during the study. The subjects found the Medi‐Jector less offputting (p < 0:01), less painful with respect to both frequency (p <0.04) and intensity (p < 0.01) and less unpleasant (p < 0.05) than a multidose injection pen with a 28G needle (p <0.01). No difference in compliance was detected. Most subjects preferred the Medi‐Jector for future use (p < 0.05). The mean score on a 1–10 point scale (10 is excellent) was 7.9 (SD 1.4) for the Medi‐Jector and 6.8 (SD2.3) for the multidose injection pen (p <0.08). The prevalence of visible bruises each day was higher (p < 0.01) with the Medi‐Jector (2.5, SD 2.1) than with the multidose injection pen (0.7, SD 1.1), but children showed indifferent affective responses to bruising. Thirteen out of 18 subjects decided to continue therapy with the Medi‐Jector (p < 0.06). It is concluded that use of the Medi‐Jector in growth hormone therapy tends to lead to fewer adverse psychological responses than a multidose injection pen with 28G needles. |
Author | Verrips, GH Delemarre-Van de Waal, HA Hirasing, RA Vogels, T Verloove-Vanhorick, SP Fekkes, M |
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Cites_doi | 10.3758/BF03334859 10.1037/0021-9010.64.2.144 10.1007/BF02072205 10.1111/j.1651-2227.1995.tb13867.x 10.1177/0193841X8000400105 10.1007/BF01983402 10.1080/00220973.1982.11011826 10.2337/diacare.16.11.1479 10.1037/0022-0167.29.3.318 |
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References_xml | – year: 1985 – volume: 16 start-page: 1479 year: 1993 end-page: 84 article-title: Jet‐injected insulin is associated with decreased antibody production and postprandial glucose variability when compared with needle‐injected insulin in gestational diabetic women publication-title: Diabetes Care – year: 1956 – volume: 153 start-page: 409 year: 1994 end-page: 10 article-title: Painfulness of needle and jet injection in children with diabetes mellitus publication-title: Eur J Pediatr – volume: 26 start-page: 51 year: 1988 end-page: 4 article-title: A method for analyzing retrospective pretest/posttest designs publication-title: Applic Bull Psychometric Soc – volume: 150 start-page: 544 year: 1991 end-page: 6 article-title: Risks of jet injection of insulin in children publication-title: Eur J Pediatr – volume: 26 start-page: 51 year: 1988 end-page: 4 article-title: A method for analyzing retrospective pretest/posttest designs: theory publication-title: Bull Psychometric Soc – volume: 50 start-page: 211 year: 1982 end-page: 4 article-title: Using retrospective pre‐ratings to counteract response‐shift confounding publication-title: J Exp Educ – year: 1995 – volume: 4 start-page: 93 year: 1980 end-page: 106 article-title: Response‐shift bias: a problem in measuring change with self‐report publication-title: Eval Rev – volume: 29 start-page: 318 year: 1982 end-page: 26 article-title: Improving methodology via research on methods publication-title: J Counsel Psychol – year: 1985 article-title: Het begrip response‐shift en retrospectieve zelf‐beoordeling publication-title: Ned Tijdschr Psychol – volume: 411 start-page: 63 year: 1995 end-page: 5 article-title: Patient evaluation of a new injection pen for growth hormone treatment in children and adults publication-title: Acta Paediatr Suppl – volume: 64 start-page: 144 year: 1979 end-page: 50 article-title: Response‐shift bias: a source of contamination in self‐report measures publication-title: J Appl Psychol – ident: e_1_2_1_7_2 doi: 10.3758/BF03334859 – year: 1985 ident: e_1_2_1_13_2 article-title: Het begrip response‐shift en retrospectieve zelf‐beoordeling publication-title: Ned Tijdschr Psychol contributor: fullname: Hoogstraten J – volume: 64 start-page: 144 year: 1979 ident: e_1_2_1_10_2 article-title: Response‐shift bias: a source of contamination in self‐report measures publication-title: J Appl Psychol doi: 10.1037/0021-9010.64.2.144 contributor: fullname: Howard GS – ident: e_1_2_1_2_2 doi: 10.1007/BF02072205 – ident: e_1_2_1_3_2 doi: 10.1111/j.1651-2227.1995.tb13867.x – ident: e_1_2_1_14_2 doi: 10.1177/0193841X8000400105 – ident: e_1_2_1_4_2 doi: 10.1007/BF01983402 – volume-title: Non‐parametric statistics for the social sciences year: 1956 ident: e_1_2_1_15_2 contributor: fullname: Siegel S – ident: e_1_2_1_12_2 doi: 10.1080/00220973.1982.11011826 – ident: e_1_2_1_6_2 – ident: e_1_2_1_8_2 doi: 10.3758/BF03334859 – ident: e_1_2_1_5_2 doi: 10.2337/diacare.16.11.1479 – volume-title: De validiteit van de retrospectieve voormeting. I. De retrospectieve voormeting en een gesprekspracticum year: 1985 ident: e_1_2_1_9_2 contributor: fullname: Sprangers M – ident: e_1_2_1_11_2 doi: 10.1037/0022-0167.29.3.318 |
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SubjectTerms | Bruising children fear human growth hormone injection pain |
Title | Psychological responses to the needle-free Medi-Jector® or the multidose Disetronic® injection pen in human growth hormone therapy |
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