Patient Reported Experience Measure in Endoscopic Ultrasonography: the PREUS Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- developing questionnaire
研究概览
简要总结
The evaluation of the patient's experience is becoming increasingly important as a better patient experience can improve the quality of the delivered health service. Patient-reported experience measures (PREMs) are self-reported assessment tools provided by patients about their experience during any health event. There are few PREMs's instruments in the field of gastrointestinal endoscopy, and none is specific for Endoscopic Ultrasound (EUS). The aim of this study is to develop a questionnaire to evaluate the experience of patients undergoing EUS, identifying and prioritizing the factors related to the patient's experience. In order of it, expected results are developing a valid tool of question to value patients experience during EUS and, for ranking, it is iphotized that will be more correlation with patients's and nurses's answer that clinicians's one. In literature is described that nurse's view and patient's view are more similar especially in those aspects concerning empatics and psychological aspects.
详细描述
The study will consist of several phases: 1) Tool creation: a "patient reported measure of EUS" (PREUS) questionnaire will be created based on literature review; 2) Face and Content Validity: The PREUS tool will be submitted to 7 experts in the field (physicians, nurses, psychologist, communication expert, patients' advocacy representative) for a two-round evaluation and to "expert" patients who had already undergone EUS at least once. Content Validity Index (CVI) will be calculated and questions with a CVI < 0.70 will be excluded; 3) Questionnaire Creation: Based on the results of phase 2, a modified "PREUS" tool will be then evaluated by ranking the relevance of the identified questions in the previous phase (from 0 to 10) by 50 outpatients undergoing EUS and Cronbach's alpha will be calculated to determine reliability; 4) Ranking: tool of phase 3 will be also evaluated by 6 physicians and 13 nurses working in IRCCS Ospedale San Raffaele endoscopy Unit to measure the agreement between patients and health care professionals (HCPs) by the Spearman-Brown coefficients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years;
- •Outpatients undergoing EUS in I.R.C.C.S. San Raffaele Hospital (Milan, Lombardy, Italy);
- •Written informed consent signed
排除标准
- 未提供
研究组 & 干预措施
Health Care Professionals
Health Care Professionals (HCP) working in PancreatoBiliary Endoscopy and EUS Division of IRCCS San Raffaele (both endoscopists and nurses)
"Expert" patients
a set of at least 30 outpatients undergoing EUS, who already underwent this procedure at least once
Patients
100 consecutive patients undergoing EUS
结局指标
主要结局
developing questionnaire
时间窗: 9 months
develop a questionnaire for Patient Reported Experience Measures during Endoscopic Ultrasound. In the first step it will be used a continuos Likert scale from 1 to 10 to analyse Content Validity Index, in the second step it will be used a score from 1 to 5 (1 = poor; 3 = good; 5 = excellent experience)
次要结局
- ranking(9 months)
研究者
Paolo Giorgio Arcidiacono, MD
MD FASGE Associate Professor of Gastroenterology, Vita-Salute San Raffaele University; Head Pancreatico/Biliary Endoscopy & Endosonography Division Pancreas Translational & Clinical Research Center San Raffaele Scientific Institute, Milan,Italy
IRCCS San Raffaele