1. A pilot study of a digital ostomy leakage notification system: impact on worry and quality of life.
- Author
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Brady, Richard RW, Fellows, Jane, Meisner, Søren, Olsen, Jesper Kenneth, Vestergaard, Martin, and Ajslev, Teresa Adeltoft
- Subjects
SURGICAL complication risk factors ,PREVENTION of surgical complications ,PILOT projects ,RESEARCH ,MEDICAL information storage & retrieval systems ,CONFIDENCE intervals ,EVALUATION of organizational effectiveness ,ILEOSTOMY ,DIGITAL health ,SURGICAL complications ,OSTOMY ,RISK assessment ,T-test (Statistics) ,PATIENTS' attitudes ,QUALITY of life ,SCALE analysis (Psychology) ,DESCRIPTIVE statistics ,RESEARCH funding ,QUESTIONNAIRES ,WORRY ,DATA analysis software ,ODDS ratio ,PATIENT care ,LONGITUDINAL method - Abstract
Background: More than 90% of people with an ostomy worry about leakage, with associated high rates of psychological morbidity. Aims: To assess the performance of a novel digital ostomy leakage notification system in subjects with faecal stomas who experience and worry about leakage. Method: A prospective, single-arm, pilot study (ClinicalTrials.gov: NCT04894084) with 25 subjects testing the product for 21 days. Subjects completed questionnaires at baseline and termination of study evaluating leakage episodes, leakage worry and quality of life (QoL). Findings: Mean age was 56 years, 60% had an ileostomy, and 40% were females. Mean episodes of leakage outside the baseplate decreased significantly from 2.8 to 0.5 episodes after 21 days' use of the test product (P<0.001), worry about leakage decreased significantly (P<0.001) and QoL improved. Conclusion: The findings indicate strong improvements to emotional health with the test product, driven by reductions in leakage incidents outside baseplate and in users' worry about leakage. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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