Inter-rater Reliability of the Reflux Finding Score Among Gastroenterologists

April 4, 2014 updated by: Yeonsoo Kim, Chuncheon Sacred Heart Hospital

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

21

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

not appliable

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Investigators

  • Study Director: Dong Kyu Kim, MD, Assistant professor, ENT department, Chuncheon Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChuncheonSHH 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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