Usability of the Novel Liraglutide 3.0 mg Pen Injector Among Overweight or Obese Adult Patients With or Without Prior Injection Experience.

BACKGROUND: Obesity is associated with multiple comorbidities and increased mortality, making it an important target for treatment. However, achieving and maintaining weight loss by diet and physical activity remains challenging, and may often require pharmacotherapy. Liraglutide 3.0 mg has recently been approved for weight management in the United States, Canada, and EU. The current analysis used a summative usability test to assess safety and effectiveness, ease of use, and training requirements for the novel liraglutide 3.0 mg pen injector. METHODS: Of the 234 participants, half received instructions for use and video-based training and/or opportunity to handle the device. All participants (excluding pharmacists) performed 6 tasks followed by post- task interviews on task difficulty, device ease of use, and any use errors, close calls, and operational difficulties. Tasks included differentiation of correct box and pen injector, medication clarity assessment, normal, dose reversal, and end-of-content injection. Number/type of use errors, close calls, and operational difficulties were evaluated. RESULTS: All assessed participants interpreted the instructions for use correctly. No potentially serious use errors, and low numbers of nonserious errors, were reported. Overall, participants committed 105 use errors related to handling, with no potential for harm. A total of 25 close calls and 44 operational difficulties were reported without any pattern indicative of a design flaw. Marked differences in the incidence of events were observed for trained versus untrained participants regardless of prior injection experience. Participants rated ease of use as 6.4/7. CONCLUSIONS: The liraglutide 3.0 mg pen injector is safe and easy to use for liraglutide administration. New device features allow for safe use after brief training.

[Appendicostomy in the treatment of severe defecation disorders in children]. / Appendikostomi i behandling af svaere afføringsforstyrrelser hos børn.

INTRODUCTION: The Malone antegrad colonic enema (MACE) has been an option in the treatment of children with severe faecal incontinence or intractable constipation at Odense University Hospital. MATERIALS AND METHODS: We did a retrospective review of 32 case records and questionnaires completed by the patients. Pre-existing conditions included anorectal anomaly, myelomeningocele, Hirschsprung's disease and idiopathic constipation. The mean age at operation was 8.7 years (range 4-16 years), and the mean follow-up time was 2.5 years (range 1-8 years). RESULTS: Of the 32 patients, 31 returned the questionnaire. Three children had obtained satisfactory colonic function, and 2 patients had had a colostomy because of an unsatisfactory result. Of the remaining 26 patients, all reported improvement and 46% were completely clean. Complications related to the stoma included stomal stenosis (41%) and stomal leakage (62%), and 54% had experienced some degree of abdominal pain during the procedure. The patients' satisfaction with the MACE procedure and their improvement in general well-being was evaluated on a scale from 1 to 10 (1 = no satisfaction/improvement; 10 = fantastic satisfaction/improvement). The results ranged from 5 to 10 (mean 9). The same results were achieved regarding well-being. CONCLUSION: The MACE is a successful management option in children with faecal incontinence or intractable constipation. Patients' stool pattern, quality of life and satisfaction are greatly improved. However, the method is not without problems.