Patient Reported Experience in Endoscopic Ultrasound (PREUS)

Patient Reported Experience Measure in Endoscopic Ultrasonography: the PREUS Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Diseases; Bile Duct Diseases

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 171

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Gabriele Capurso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Outpatients undergoing EUS in I.R.C.C.S. San Raffaele Hospital (Milan, Lombardy, Italy); HCP involved with EUS in I.R.C.C.S S. Raffaele Hospital (OSR).

Description

Inclusion Criteria:

• Age > 18 years;
• Outpatients undergoing EUS in I.R.C.C.S. San Raffaele Hospital (Milan, Lombardy, Italy);
• Written informed consent signed

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
developing questionnaire	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)	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ranking	identify aspects of care that are most relevant both for patients undergoing EUS and HCPs involved in this procedure on a continuous Likert scale from 1 to 10 (1 = less important; 5 = relatively important; 10 = more important).	9 months

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: questionnaire; pancreatic; endoscopic ultrasonography; patient reported experience measures
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases
• Other Study ID Numbers: PREUS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No