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

Abstract

BackgroundLeakage 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.MethodsParticipants 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.ResultsA 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).ConclusionThe 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.Electronic supplementary materialThe online version of this article (10.1186/s12955-018-1054-0) contains supplementary material, which is available to authorized users.

Quality of Life Assessment in Intestinal Stoma Patients in the Saudi Population: A Cross- sectional Study

“…These are annoying as these interfer with activities at home, work, sports, and social and religious settings. In the Ostomy Life Study, 91% of patients expressed concern about leakage [20]. Our study also endorsed it.…”

“…The most troublesome and negatively impacting QoL is a poor stoma site, precipitated by obesity, emergency surgery, cancer, and improper technique [17,18]. A poorly placed stoma increases the risk of leakage, pouch ill-tting, and parastomal complications, and also has been associated with sexual dysfunction, insomnia, weight loss, and depression [19,20]. It was also a signi cant negative factor in our patients' QoL.…”

“…About 75% of stoma patients might suffer from parastomal skin complications -the majority due to leakage and adhesives [20]. These are more common in patients who had ileostomies rather than colostomies.…”

City of Hope Quality of Life-Ostomy Questionnaire Validity and Reliability Assessment on a Croatian Sample

“…According to data from relevant scientific literature, 700,000 Europeans have ostomy, while in the US there are about 750,000 patients suffering from this condition [1]. The main causes of ostomy surgeries include colorectal carcinoma (CRC), inflammatory bowel disease (IBD), trauma, acute diverticulitis, ileus, bladder cancer, and other diseases.…”

Lived experiences of patients with ostomies in a University Teaching Hospital in Kwara State, Nigeria

“…(2017) where a considerable number of the participants who returned to work post-ostomy period had a decline in the performance of their professional activities. Conversely, a study has shown that ostomates go through anger and panic due to the need to check for leaks and these emotions could lead to anxiety and social isolation ( Nafees et al., 2018 ). One participant however did not experience any decline in work activities.…”