Inter-rater Reliability of the Reflux Finding Score Among Gastroenterologists

Completed

• Conditions: Laryngitis; Reflux

• Registration Number: NCT02048449
• Lead Sponsor: Chuncheon Sacred Heart Hospital

Brief Summary

Title:

Inter-rater reliability of the reflux finding score based on endoscopic laryngeal findings in the diagnosis of laryngopharyngeal reflux disease

Participants:

Voluntary participants after invitation among members (a total of about 40 gastroenterologists) of Gangwon Branch of Korean Society of Gastrointestinal Endoscopy and an otorhinolaryngologist

Primary endpoint:

Interrater reliability (Kappa coefficient) on the sum of reflux finding score more than 7 points between an otorhinolaryngologist and gastroenterologists (7 points means the cut-off value for the diagnosis of laryngopharyngeal reflux disease)

Secondary endpoint:

Agreement (%) on 8 items of reflux finding score for laryngopharygeal reflux among gastroenterologists

Detailed Description

Study Design

1. Recruitment of doctor participants: introduction by e-mail

2. Education on reflux finding score - standardized materials (instructional video)

3. PRETEST (15 pictures) / feedback (at-a-glance assessment format)

4. TEST 1 (50 pictures) - Acess format including 8 items at each pictures

5. Feedback education (individualized intruction of an otorhinolaryngologist)

6. TEST 2 (50 pictures) - Acess format including 8 items at each pictures

7. Test-Retest reliability - repeat Test 2 with 1 week interval (Participants should take retest of TEST 2 with the concealment of the answer)

8. Analysis

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-29
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Participants: Gastroenterologists (GI specialists) or trainees /
• Pictures: Endoscopic laryngeal pictures with good quality

Exclusion Criteria

• Participants: Major other than gastroenterology /
• Pictures: Endoscopic laryngeal pictures without good quality

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cohen's kappa coefficient	5 months	Cohen's Kappa coefficient based on the sum of reflux finding scores (7 points or more than 7) for the diagnosis of laryngopharyngeal reflux disease between an otorhinolaryngologist (reference) and participant gastroenterologists

Secondary Outcome Measures

Name	Time	Method
Agreement (%) at each item out of 8 items of reflux finding score	5 months	Agreement (%) at each item out of 8 items (subglottic edema, ventricular obliteration, laryngeal erythema, vocal cord edema, diffuse laryngeal edema, posterior commissure hypertrophy, laryngeal granuloma, thick endolaryngeal mucus) of reflux finding score