Clinical Trial: Inter-rater Reliability of the Reflux Finding Score Among Gastroenterologists

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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

Sponsor: Chuncheon Sacred Heart Hospital

Current Primary Outcome: Cohen's kappa coefficient [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Agreement (%) at each item out of 8 items of reflux finding score [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: Chuncheon Sacred Heart Hospital

Dates:
Date Received: January 21, 2014
Date Started: January 2014
Date Completion:
Last Updated: April 4, 2014
Last Verified: April 2014