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Andreas Pfutzner - One of the best experts on this subject based on the ideXlab platform.
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Evaluation of the insulin application system AutoPen 24
Practical Diabetes International, 2020Co-Authors: Martin Larbig, T Forst, S. Forst, B Lorra, K König, T Fittkau, Andreas PfutznerAbstract:In patients with insulin therapy, a simple to use, reliable and safe insulin application device is a prerequisite to achieve good glucose control, and for reducing and avoiding progression of secondary complications. Modern Injection Pen systems provide the patient with a high degree of flexibility and quality of life. However, the integration of further and appropriate therapeutic aids into a device can make a positive contribution to compliance and therapy satisfaction. In this multicentre, oPen, randomised, three-month, cross-over study, the new insulin application device AutoPen 24® (designed for Sanofi-Aventis insulin cartridges) was evaluated in comparison to the established OptiPen® Pro device with regard to clinical efficacy (HbA1c, frequency of severe hypoglycaemic episodes) and patients' preference and acceptance in 40 patients (20 women, 20 men; 20 type 1, 20 type 2; age [mean±SD] 49.3±15.1 years; BMI 29.0±5.0 kg/m2). No differences were seen regarding HbA1c and hypoglycaemic episodes between the treatment groups. The AutoPen 24 showed a high level of acceptance by patients in comparison to OptiPen Pro and was preferred by older patients with type 2 diabetes. In conclusion, AutoPen 24 is a suitable alternative to other Injection devices in patients with diabetes mellitus treated with Sanofi-Aventis insulin products. Copyright © 2005 John Wiley & Sons, Ltd.
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Patient device assessment evaluation of two insulin Injection devices in a mixed cohort of insulin-treated patients with type 1 or type 2 diabetes mellitus
Current Medical Research and Opinion, 2012Co-Authors: C Schipper, Marcus Niemeyer, Marianne Qvist, Andrea Loffler, T Forst, P B Musholt, Andreas PfutznerAbstract:AbstractObjective:FT (FlexTouch) is a new disposable insulin Injection Pen device for use in insulin-treated patients with diabetes mellitus. The aim of this study was to evaluate patient perception of FT versus IL (InnoLet) with respect to the ease of use and patient preference in a mixed patient cohort with different kinds and degrees of visual or dexterity impairments. *FlexTouch is a registered trade name of NovoNordisk A/S, Soborg, Denmark. †InnoLet is a registered trade name of NovoNordisk A/S, Soborg, Denmark. Methods:Ninety patients were included into this investigation (54 male/36 female, age [mean ± SD]: 62 ± 8 yrs, disease duration: 18 ± 11 yrs, HbA1c: 7.2 ± 1.0%). After assessment of visual acuity and dexterity skills (by Jebsen–Taylor Hand Function Test), the patients were introduced to the two Pen devices in random order, and were asked to perform mock Injections with 10 IU, 30 IU and 50 IU doses before completing a 41 item standardized device assessment questionnaire. The questions asked we...
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comparison of patient preference for two insulin Injection Pen devices in relation to patient dexterity skills
Journal of diabetes science and technology, 2012Co-Authors: Andreas Pfutzner, C Schipper, Marcus Niemeyer, Marianne Qvist, Andrea Loffler, T Forst, P B MusholtAbstract:Background:Impaired dexterity has been reported to be prevalent in diabetes patients indePendent from the existence of diabetic neuropathy. This study was performed to investigate the impact of dexterity impairment on patient preference for two insulin Pen Injection devices (InnoLet and FlexTouch).Methods:Ninety patients [54 male/36 female; age (mean ± standard deviation), 62 ± 8 years; disease duration, 18 ± 11 years; hemoglobin A1c, 7.2 ± 1.0%] were included in this investigation and were stratified into four different groups based on the results of a dexterity test (Jebsen—Taylor Hand Function Test) and assessment of visual impairment: 15 type 1 (group A) and 30 type 2 (group B) patients with impaired dexterity, 30 type 1/type 2 patients with visual impairment (group C), and 15 type 1/type 2 patients without any impairment (group D). The patients performed a cognitive function test (number connection test), were introduced to the devices in random order, and were asked to perform some mock Injections b...
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intuitiveness ease of use and preference of a prefilled growth hormone Injection Pen a noninterventional randomized oPen label crossover comparative usability study of three delivery devices in growth hormone treated pediatric patients
Clinical Therapeutics, 2010Co-Authors: Andreas Pfutzner, Anne-marie Kappelgaard, Klaus Hartmann, Franziska Winter, Gitte Schoning Fuchs, Tilman R RohrerAbstract:Abstract Background: Growth hormone (GH) is used to treat pediatric and adult GH deficiency (GHD) and growth failure in, among others, patients with Turner syndrome or children born small for gestational age. To improve treatment adherence, self-Injection devices should be easy to learn, easy to use, and well accepted, especially in pediatric patients. Several GH Pen devices are available, each with distinct features designed for specific patient needs. Objectives: This study compared Injection time and intuitiveness of a prefilled test Injection device (Norditropin FlexPro, Novo Nordisk A/S, Bagsvaerd, Denmark) with those of 2 commercially available durable Injection devices (easypod, Merck Serono SA, Geneva, Switzerland; and Genotropin, Pfizer Inc, New York, New York) in GH-treated pediatric patients. Dose accuracy, application errors, intuitiveness, usability, device features, ease of learning, ease of use, and overall preference were also assessed. Methods: This noninterventional, randomized, oPenlabel, crossover study enrolled patients aged ≥10 to Results: Included in the study were 56 patients (mean [SD] age, 13.6 [2.1] years; 63% male; GHD, 44 patients; Turner syndrome, 3; born small for gestational age, 9): 30 in the intuitiveness group and 26 in the instruction group. In the intuitiveness group, the mean (SD) mock Injection time was significantly shorter with FlexPro (47.0 [49.0] seconds) than with the easypod (219.2 [72.6] seconds; P P P P Conclusion: In this study, Norditropin FlexPro was associated with shorter Injection times, higher dose accuracy, and greater intuitiveness, and was rated as easier to learn compared with the easypod and Genotropin devices.
A Pleil - One of the best experts on this subject based on the ideXlab platform.
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results from an international multicenter trial evaluating the ease of use of and preference for a newly developed disposable Injection Pen for the treatment of growth hormone deficiency in treatment naive children and adults
Medical Devices : Evidence and Research, 2014Co-Authors: A Pleil, Feyza Darendeliler, Helmuth G Dorr, Katherine Hutchinson, Hartmut A WollmannAbstract:Previous research has reported that ease of use of and preference for a delivery device are associated with greater patient compliance – an important factor in achieving optimal therapeutic results. The objective of this study was to assess the ease-of-use of a new disposable Pen (GoQuick®, Pfizer, Inc.) versus the current reusable Pen (GENOTROPIN Pen®, Pfizer, Inc.) to inject a daily dose of recombinant DNA origin human growth hormone, Genotropin® (somatropin) in standard practice. In this randomized, crossover, multicenter, multinational, oPen-label study, ease-of-use of and preference for the two Pens were assessed in three treatment-naive populations: 1) parents of very young children; 2) parent–child dyads; and 3) adults via use of a validated self-report Injection Pen Assessment Questionnaire (IPAQ) after 2 months of at-home-use experience. The primary endpoint was the proportion of participants who reported the new disposable Pen to be no different from or easier to use than the current reusable Pen. Safety was also assessed and reported according to local legal requirements. Of the 120 screened patients, 119 were included in the ease-of-use analysis and all were included in the safety analyses. In all, 67.2% found the new somatropin disposable Pen to be no different from or easier to use than the reusable Pen (95% confidence interval: 58.8–75.7). Most adverse events were mild or moderate. No deaths or device- or treatment-related serious adverse events were reported. These results suggest that improvements made to the reusable somatropin Pen are tangible and recognizable to treatment-naive patients and their caregivers, child–caregiver dyads, and adults, and may positively impact continued compliance with therapy. Registry information ClinicalTrials.gov identifier: {"type":"clinical-trial","attrs":{"text":"NCT01112865","term_id":"NCT01112865"}}NCT01112865.
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psychometric assessment of the Injection Pen assessment questionnaire ipaq measuring ease of use and preference with Injection Pens for human growth hormone
Health and Quality of Life Outcomes, 2012Co-Authors: A Pleil, Miriam Kimel, J Mccormack, Natasa Rajicic, Judith HeyhadaviAbstract:To examine the psychometric properties of the Injection Pen Assessment Questionnaire (IPAQ) including the following: 1) item and scale characteristics (e.g., frequencies, item distributions, and factor structure), 2) reliability, and 3) validity. Focus groups and one-on-one dyad interviews guided the development of the IPAQ. The IPAQ was subsequently tested in 136 parent–child dyads in a Phase 3, 2-month, oPen-label, multicenter trial for a new Genotropin® disposable Pen. Factor analysis was performed to inform the development of a scoring algorithm, and reliability and validity of the IPAQ were evaluated using the data from this two months study. Psychometric analyses were conducted separately for each Injection Pen. Confirmatory factor analysis provides evidence supporting a second order factor solution for four subscales and a total IPAQ score. These factor analysis results support the conceptual framework developed from previous qualitative research in patient dyads using the reusable Pen. However, the IPAQ subscales did not consistently meet acceptable internal consistency reliability for some group level comparisons. Cronbach’s alphas for the total IPAQ score for both Pens were 0.85, exceeding acceptable levels of reliability for group comparisons. The total IPAQ score is a useful measure for evaluating ease of use and preference for Injection Pens in clinical trials among patient dyads receiving hGH. The psychometric properties of the individual subscales, mainly the lower internal consistency reliability of some of the subscales and the predictive validity findings, do not support the use of subscale scores alone as a primary endpoint.
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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
Clinical Therapeutics, 2010Co-Authors: Judith Heyhadavi, A Pleil, Natasa Rajicic, Larry Deeb, John S Fuqua, Lawrence A Silverman, Barry J Reiner, Ron S Newfield, Michael P Wajnrajch, Jose CaraAbstract: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/m 2 ; 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.
Judith Heyhadavi - One of the best experts on this subject based on the ideXlab platform.
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psychometric assessment of the Injection Pen assessment questionnaire ipaq measuring ease of use and preference with Injection Pens for human growth hormone
Health and Quality of Life Outcomes, 2012Co-Authors: A Pleil, Miriam Kimel, J Mccormack, Natasa Rajicic, Judith HeyhadaviAbstract:To examine the psychometric properties of the Injection Pen Assessment Questionnaire (IPAQ) including the following: 1) item and scale characteristics (e.g., frequencies, item distributions, and factor structure), 2) reliability, and 3) validity. Focus groups and one-on-one dyad interviews guided the development of the IPAQ. The IPAQ was subsequently tested in 136 parent–child dyads in a Phase 3, 2-month, oPen-label, multicenter trial for a new Genotropin® disposable Pen. Factor analysis was performed to inform the development of a scoring algorithm, and reliability and validity of the IPAQ were evaluated using the data from this two months study. Psychometric analyses were conducted separately for each Injection Pen. Confirmatory factor analysis provides evidence supporting a second order factor solution for four subscales and a total IPAQ score. These factor analysis results support the conceptual framework developed from previous qualitative research in patient dyads using the reusable Pen. However, the IPAQ subscales did not consistently meet acceptable internal consistency reliability for some group level comparisons. Cronbach’s alphas for the total IPAQ score for both Pens were 0.85, exceeding acceptable levels of reliability for group comparisons. The total IPAQ score is a useful measure for evaluating ease of use and preference for Injection Pens in clinical trials among patient dyads receiving hGH. The psychometric properties of the individual subscales, mainly the lower internal consistency reliability of some of the subscales and the predictive validity findings, do not support the use of subscale scores alone as a primary endpoint.
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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
Clinical Therapeutics, 2010Co-Authors: Judith Heyhadavi, A Pleil, Natasa Rajicic, Larry Deeb, John S Fuqua, Lawrence A Silverman, Barry J Reiner, Ron S Newfield, Michael P Wajnrajch, Jose CaraAbstract: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/m 2 ; 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.
Jose Cara - One of the best experts on this subject based on the ideXlab platform.
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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
Clinical Therapeutics, 2010Co-Authors: Judith Heyhadavi, A Pleil, Natasa Rajicic, Larry Deeb, John S Fuqua, Lawrence A Silverman, Barry J Reiner, Ron S Newfield, Michael P Wajnrajch, Jose CaraAbstract: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/m 2 ; 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.
Göran Ingemar Petersson - One of the best experts on this subject based on the ideXlab platform.
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3D visualization as a communicative aid in pharmaceutical advice-giving over distance
Journal of Medical Internet Research, 2011Co-Authors: Martin Östlund, Nils Dahlbäck, Göran Ingemar PeterssonAbstract:BACKGROUND: Medication misuse results in considerable problems for both patient and society. It is a complex problem with many contributing factors, including timely access to product information.\n\nOBJECTIVE: To investigate the value of 3-dimensional (3D) visualization paired with video conferencing as a tool for pharmaceutical advice over distance in terms of accessibility and ease of use for the advice seeker.\n\nMETHODS: We created a Web-based communication service called AssistancePlus that allows an advisor to demonstrate the physical handling of a complex pharmaceutical product to an advice seeker with the aid of 3D visualization and audio/video conferencing. AssistancePlus was tested in 2 separate user studies performed in a usability lab, under realistic settings and emulating a real usage situation. In the first study, 10 pharmacy students were assisted by 2 advisors from the Swedish National Co-operation of Pharmacies' call centre on the use of an asthma inhaler. The student-advisor interview sessions were filmed on video to qualitatively explore their experience of giving and receiving advice with the aid of 3D visualization. In the second study, 3 advisors from the same call centre instructed 23 participants recruited from the general public on the use of 2 products: (1) an insulin Injection Pen, and (2) a growth hormone Injection syringe. First, participants received advice on one product in an audio-recorded telephone call and for the other product in a video-recorded AssistancePlus session (product order balanced). In conjunction with the AssistancePlus session, participants answered a questionnaire regarding accessibility, perceived expressiveness, and general usefulness of 3D visualization for advice-giving over distance compared with the telephone and were given a short interview focusing on their experience of the 3D features.\n\nRESULTS: In both studies, participants found the AssistancePlus service helpful in providing clear and exact instructions. In the second study, directly comparing AssistancePlus and the telephone, AssistancePlus was judged positively for ease of communication (P = .001), personal contact (P = .001), explanatory power (P < .001), and efficiency (P < .001). Participants in both studies said that they would welcome this type of service as an alternative to the telephone and to face-to-face interaction when a physical meeting is not possible or not convenient. However, although AssistancePlus was considered as easy to use as the telephone, they would choose AssistancePlus over the telephone only when the complexity of the question demanded the higher level of expressiveness it offers. For simpler questions, a simpler service was preferred.\n\nCONCLUSIONS: 3D visualization paired with video conferencing can be useful for advice-giving over distance, specifically for issues that require a higher level of communicative expressiveness than the telephone can offer. 3D-supported advice-giving can increase the range of issues that can be handled over distance and thus improve access to product information.