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.

Automated Assessment of Peristomal Skin Discoloration and Leakage Area Using Artificial Intelligence.

For people living with an ostomy, development of peristomal skin complications (PSCs) is the most common post-operative challenge. A visual sign of PSCs is discoloration (redness) of the peristomal skin often resulting from leakage of ostomy output under the baseplate. If left unattended, a mild skin condition may progress into a severe disorder; consequently, it is important to monitor discoloration and leakage patterns closely. The Ostomy Skin Tool is current state-of-the-art for evaluation of peristomal skin, but it relies on patients visiting their healthcare professional regularly. To enable close monitoring of peristomal skin over time, an automated strategy not relying on scheduled consultations is required. Several medical fields have implemented automated image analysis based on artificial intelligence, and these deep learning algorithms have become increasingly recognized as a valuable tool in healthcare. Therefore, the main objective of this study was to develop deep learning algorithms which could provide automated, consistent, and objective assessments of changes in peristomal skin discoloration and leakage patterns. A total of 614 peristomal skin images were used for development of the discoloration model, which predicted the area of the discolored peristomal skin with an accuracy of 95% alongside precision and recall scores of 79.6 and 75.0%, respectively. The algorithm predicting leakage patterns was developed based on 954 product images, and leakage area was determined with 98.8% accuracy, 75.0% precision, and 71.5% recall. Combined, these data for the first time demonstrate implementation of artificial intelligence for automated assessment of changes in peristomal skin discoloration and leakage patterns.

The ostomy leak impact tool: development and validation of a new patient-reported tool to measure the burden of leakage in ostomy device users.

BACKGROUND: Leakage is a major concern for people who use a stoma, but people's experience and its impact is not well understood. This study aimed to establish a definition of leakage through clinical and user input. This information was used to develop and validate a new measurement tool to understand the impact of leakage for people using a stoma appliance, in the UK, US, France, and Denmark. METHODS: Participants were recruited from a panel of users, hosted by Coloplast, that includes people who currently use Coloplast products. Six clinicians and 41 users took part in concept elicitation interviews. The qualitative findings were used to draft items. A panel of clinical experts was organized to develop and validate items (N = 6). Cognitive debrief interviews were conducted with five users in each country, which resulted in removing some items and revising the measure. A psychometric validation was conducted with 340 people in four countries whereby participants were asked to complete a series of measures online. Full psychometric analyses including validity and reliability were conducted. RESULTS: A final tool was established consisting of three domains related to the burden of leakage: "Emotional impact," "Usual and social activities," and "Coping and control." Convergent validity was evaluated by benchmarking to existing health-related quality of life instruments (domains of SF-36 and Ostomy-Q). This showed high correlation between domains of the leakage tool and other measures, in particular for the Emotional impact domain when compared with SF-36 Emotional well-being and Ostomy-Q Confidence domain (p < 0.001). Coping and control correlated moderately well with most PROs tested for except the physical functioning domains, which showed only modest correlation (p < 0.001). Usual and social activities correlated equally well with all domains. Internal consistency was high for Emotional impact and Usual and social activities (> 0.92). CONCLUSION: The study highlights how users define leakage and its impact in a way that is meaningful to them. This information has been used to develop an instrument to measure leakage which can potentially be used by clinicians and researchers. The instrument demonstrated evidence supporting its reliability and validity as an outcome measure to assess the impact of leakage in stoma care.

Differences in Ostomy Pouch Seal Leakage Occurrences Between North American and European Residents.

PURPOSE: The purpose of this study was to compare experiences and concerns about pouch seal leakage between persons with ostomies residing in North America (Canada and the United States) and Europe (United Kingdom, Netherlands, Sweden, Germany, Belgium, France, and Italy). Differences in reported pouch wear time and accessories used between the 2 groups were also examined. DESIGN: Secondary analysis of data from a cross-sectional study (Ostomy Life Study). SUBJECTS AND SETTINGS: Responses from persons residing in European countries (n = 1939) were compared with responses of 1387 individuals residing in North American countries. METHODS: Persons with an ostomy completed a questionnaire that focused on 4 topics related to the daily use of an ostomy pouching system (pouch seal leakage, ballooning, appearance of pouching system such as color and size of the pouch and whether it is discrete under clothing, and coupling failure of 2-piece pouching systems). Pouch seal leakage was defined as stomal effluent seeping between the skin and the wafer of the ostomy pouching system. Statistical analysis was performed using a proportional odds model including various variable effects. Special attention was given to frequency of pouch seal leakage occurrences. All tests were 2-sided; P values ≤.05 were deemed statistically significant. RESULTS: Participants living in the North American countries indicated they were more likely to experience leakage from the ostomy (odds ratio = 2.610, 95% CI 2.187-3.115; P < .0001). Findings also indicated they were more likely to worry about pouch seal leakage than those in the European countries' data set (odds ratio = 2.722, 95% CI 2.283-3.246; P < .0001). Participants residing in the North American countries had significantly longer wear times than those participants in the European countries (P < .0001, χ test). The use of accessories was associated with a longer pouching system wear time. CONCLUSION: Study results suggest that participants from the North American countries indicated significantly more experience with and worries about leakage and longer wear time than the participants from the European population. Additional research is needed to determine the reasons for these differences.

Long-Term Cost-Effectiveness of Transanal Irrigation in Patients with Neurogenic Bowel Dysfunction.

BACKGROUND: People suffering from neurogenic bowel dysfunction (NBD) and an ineffective bowel regimen often suffer from fecal incontinence (FI) and related symptoms, which have a huge impact on their quality of life. In these situations, transanal irrigation (TAI) has been shown to reduce these symptoms and improve quality of life. AIM: To investigate the long-term cost-effectiveness of initiating TAI in patients with NBD who have failed standard bowel care (SBC). METHODS: A deterministic Markov decision model was developed to project the lifetime health economic outcomes, including quality-adjusted life years (QALYs), episodes of FI, urinary tract infections (UTIs), and stoma surgery when initiating TAI relative to continuing SBC. A data set consisting of 227 patients with NBD due to spinal cord injury (SCI), multiple sclerosis, spina bifida and cauda equina syndrome was used in the analysis. In the model a 30-year old individual with SCI was used as a base-case. A probabilistic sensitivity analysis was applied to evaluate the robustness of the model. RESULTS: The model predicts that a 30-year old SCI patient with a life expectancy of 37 years initiating TAI will experience a 36% reduction in FI episodes, a 29% reduction in UTIs, a 35% reduction in likelihood of stoma surgery and a 0.4 improvement in QALYs, compared with patients continuing SBC. A lifetime cost-saving of £21,768 per patient was estimated for TAI versus continuing SBC alone. CONCLUSION: TAI is a cost-saving treatment strategy reducing risk of stoma surgery, UTIs, episodes of FI and improving QALYs for NBD patients who have failed SBC.

Integrative analysis for finding genes and networks involved in diabetes and other complex diseases.

We have developed an integrative analysis method combining genetic interactions, identified using type 1 diabetes genome scan data, and a high-confidence human protein interaction network. Resulting networks were ranked by the significance of the enrichment of proteins from interacting regions. We identified a number of new protein network modules and novel candidate genes/proteins for type 1 diabetes. We propose this type of integrative analysis as a general method for the elucidation of genes and networks involved in diabetes and other complex diseases.

A human phenome-interactome network of protein complexes implicated in genetic disorders.

We performed a systematic, large-scale analysis of human protein complexes comprising gene products implicated in many different categories of human disease to create a phenome-interactome network. This was done by integrating quality-controlled interactions of human proteins with a validated, computationally derived phenotype similarity score, permitting identification of previously unknown complexes likely to be associated with disease. Using a phenomic ranking of protein complexes linked to human disease, we developed a Bayesian predictor that in 298 of 669 linkage intervals correctly ranks the known disease-causing protein as the top candidate, and in 870 intervals with no identified disease-causing gene, provides novel candidates implicated in disorders such as retinitis pigmentosa, epithelial ovarian cancer, inflammatory bowel disease, amyotrophic lateral sclerosis, Alzheimer disease, type 2 diabetes and coronary heart disease. Our publicly available draft of protein complexes associated with pathology comprises 506 complexes, which reveal functional relationships between disease-promoting genes that will inform future experimentation.

Immune-mediated beta-cell destruction in vitro and in vivo-A pivotal role for galectin-3.

Pro-apoptotic cytokines are toxic to the pancreatic beta-cells and have been associated with the pathogenesis of Type 1 diabetes (T1D). Proteome analysis of IL-1beta exposed isolated rat islets identified galectin-3 (gal-3) as the most up-regulated protein. Here analysis of human and rat islets and insulinoma cells confirmed IL-1beta regulated gal-3 expression of several gal-3 isoforms and a complex in vivo expression profile during diabetes development in rats. Over-expression of gal-3 protected beta-cells against IL-1beta toxicity, with a complete blockage of JNK phosphorylation, essential for IL-1-mediated apoptosis. Mutation scanning of regulatory and coding regions of the gal-3 gene (LGALS3) identified six polymorphisms. A haplotype comprising three cSNPs showed significantly increased transmission to unaffected offspring in 257 T1D families and replicated in an independent set of 170 T1D families. In summary, combined proteome-transcriptome-genome and functional analyses identify gal-3 as a candidate gene/protein in T1D susceptibility that may prove valuable in future intervention/prevention strategies.