Psychometric validation of the Ostomy Skin Tool 2.0.

Background: Peristomal skin complications (PSCs) pose a major challenge for people living with an ostomy. To avoid severe PSCs, it is important that people with an ostomy check their peristomal skin condition on a regular basis and seek professional help when needed. Aim: To validate a new ostomy skin tool (OST 2.0) that will make regular assessment of the peristomal skin easier. Methods: Seventy subjects participating in a clinical trial were eligible for the analysis and data used for the validation. Item-level correlation with anchors, inter-item correlations, convergent validity of domains, test-retest reliability, anchor- and distribution-based methods for assessment of meaningful change were all part of the psychometric validation of the tool. Results: A final tool was established including six patient reported outcome items and automatic assessment of the discolored peristomal area. Follow-up with cognitive debriefing interviews assured that the concepts were considered relevant for people with an ostomy. Conclusion: The OST 2.0 demonstrated evidence supporting its reliability and validity as an outcome measure to capture both visible and non-visible peristomal skin complications.

An ostomy baseplate with a skin-protection technology reduces peristomal skin complications: a randomized controlled trial (the ATTRACT study).

BACKGROUND: Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, negatively affecting their health-related quality of life (HRQoL). PSCs may also have an impact on healthcare costs for society with more visits to healthcare professionals and increased consumption of products and treatment strategies, which amplifies the need for new strategies to reduce or prevent PSCs. OBJECTIVES: To evaluate the performance of an ostomy baseplate with a skin-protection technology. The target group comprised people living with a stoma with liquid faecal effluent, who struggled with PSCs. METHODS: A randomized, controlled, open-labelled, cross-over trial was conducted from September 2021 to February 2022 in five different countries. Each participant tested the investigational product against a comparator product (SenSura® Mio). The Ostomy Skin Tool 2.0 was used to evaluate the peristomal skin and HRQoL was measured using the Dermatology Life Quality Index (DLQI) questionnaire. Data were analysed in mixed repeated-measures models. RESULTS: A total of 79 adult participants (mean age 54.5 years, female 45.6%) were included in the intention-to-treat (ITT) population. A significant reduction in PSCs (P = 0.015) and HRQoL (P = 0.035) was found for the investigational product when compared with the comparator product. Also, significantly more study participants preferred the investigational product when compared with the comparator product (P = 0.017). CONCLUSIONS: The investigational product, an ostomy baseplate with a skin-protective technology, reduced PSCs and improved the HRQoL of people living with a stoma with liquid faecal effluent. Consequently, the investigational product was the preferred ostomy appliance of the participants. Thus, the product investigated in this study may be a new solution to be included in everyday clinical practice to overcome leakage-induced PSCs for people living with a stoma.

Safety and patient perception of an insulin pen with simple memory function for children and adolescents with type 1 diabetes--the REMIND study.

OBJECTIVES: NovoPen Echo * is a durable pediatric insulin pen incorporating half-unit dosing starting at 0.5 units and a last-dose memory function. The REMIND † (Rating the Effects of Memory function in pediatric INsulin Devices) study primarily examined the safety of this new device by collecting data on technical complaints (TCs) related to adverse reactions (ARs) during use in a clinical setting. METHODS: REMIND was an observational, multicenter study involving patients with type 1 diabetes on injection therapy, aged 2-18 years, from Canada, Finland, Israel and Sweden. Questionnaires and case report forms were completed at baseline and after using NovoPen Echo for 12-18 weeks. RESULTS: In total, 358 patients participated and 315 completed. No serious ARs were reported. Three ARs related to TCs were reported, equated to one every 29 patient-years. Most patients found it 'easy' or 'somewhat easy' to read amount (99%) and hours lapsed (95%) since last dose using the memory function. The proportion of children self-injecting was significantly higher (71%) compared with those on previous device (66%, p=0.006). 80% of physicians answers reported they could train users in ≤10 minutes. CONCLUSIONS: Only three device safety events were reported for NovoPen Echo. Physicians found it easy and quick to educate users. Patients/caregivers missed fewer injections and reported greater confidence in managing their insulin injections. As this was an observational study without controls or centralized laboratory testing, caution should be used in interpreting outcomes in glycemic control. Further studies are required to examine the effects of features such as memory function and half-unit dosing on HbA1c and hypoglycemia over a longer time period.