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
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 |
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
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chuncheon Sacred Heart Hospital |
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 |
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