Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2026
Exploring the disease burden and quality of life in patients with short bowel syndrome with intestinal failure: Insights from exit interviews in the glepaglutide EASE SBS-1 phase 3 trial.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Mercer David F, Mubekapi-Musadaidzwa Constance, Kloster Bitten, Berner-Hansen Mark, Rydén Anna, Jeppesen Palle Bekker
Аннотация
BACKGROUND: A randomized, double-blind, placebo-controlled trial was conducted to evaluate efficacy and safety of glepaglutide in patients who have short bowel syndrome with intestinal failure (SBS-IF). At the end of the trial, exit interviews were conducted to explore participants' experiences and to assess the impact of the disease and treatment during the trial.
METHODS: Thirty patients from four countries were interviewed over the phone. Data were collected using a semistructured interview manual, and interviews were recorded and transcribed for analysis.
RESULTS: Patients reported that SBS-IF negatively impacted their lives before the trial, causing loss of freedom, disrupted sleep, limited physical activity, and pain. During the interviews, patients reported that the treatment improved their well-being across multiple domains. Seventy-three percent of the patients receiving glepaglutide (n = 16/22) reported positive changes in health-related quality of life compared with 25% receiving placebo (n = 2/8). Twenty-six patients reported experiencing a reduction in parenteral support (PS) volume. Of these, 21 patients (18 glepaglutide, three placebo) reported a change in overall status, with 94% receiving glepaglutide (n = 17/18) and 67% (n = 2/3) receiving the placebo finding this change meaningful. Although descriptive, these findings should be interpreted cautiously given the small number of patients.
CONCLUSION: During exit interviews, patients receiving glepaglutide reported improvements in well-being across multiple domains, noting meaningful reductions in PS volume and a reduced impact of SBS-IF on daily life, which was proportionally greater than in those receiving placebo. These findings underscore the patient-reported positive experiences of glepaglutide and its beneficial effects.
METHODS: Thirty patients from four countries were interviewed over the phone. Data were collected using a semistructured interview manual, and interviews were recorded and transcribed for analysis.
RESULTS: Patients reported that SBS-IF negatively impacted their lives before the trial, causing loss of freedom, disrupted sleep, limited physical activity, and pain. During the interviews, patients reported that the treatment improved their well-being across multiple domains. Seventy-three percent of the patients receiving glepaglutide (n = 16/22) reported positive changes in health-related quality of life compared with 25% receiving placebo (n = 2/8). Twenty-six patients reported experiencing a reduction in parenteral support (PS) volume. Of these, 21 patients (18 glepaglutide, three placebo) reported a change in overall status, with 94% receiving glepaglutide (n = 17/18) and 67% (n = 2/3) receiving the placebo finding this change meaningful. Although descriptive, these findings should be interpreted cautiously given the small number of patients.
CONCLUSION: During exit interviews, patients receiving glepaglutide reported improvements in well-being across multiple domains, noting meaningful reductions in PS volume and a reduced impact of SBS-IF on daily life, which was proportionally greater than in those receiving placebo. These findings underscore the patient-reported positive experiences of glepaglutide and its beneficial effects.