Inter-rater Reliability of the Reflux Finding Score Among Gastroenterologists

Reflux Clinical Trial

Official title:

Inter-rater Reliability of the Reflux Finding Score Based on Endoscopic Laryngeal Findings in the Diagnosis of Laryngopharyngeal Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048449
• Other study ID #: ChuncheonSHH 2013
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: April 4, 2014
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Laryngitis
• Reflux

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohen's kappa coefficient	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	5 months	No
Secondary	Agreement (%) at each item out of 8 items of reflux finding score	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	5 months	No