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CompletedNCT02048449Updated Apr 7, 2014

Inter-rater Reliability of the Reflux Finding Score Among Gastroenterologists

An observational study in Laryngitis and Reflux, sponsored by Chuncheon Sacred Heart Hospital. Completed. Per ClinicalTrials.gov, last updated 2014-04-07.

Sponsored by Chuncheon Sacred Heart Hospital · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
21
Sex
All
01

Study 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

Read the 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
02

Conditions studied

  • Laryngitis
  • Reflux

Keywords

  • Reflux finding score, interrater reliability
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

not appliable

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Participants: Major other than gastroenterology /
  • Pictures: Endoscopic laryngeal pictures without good quality
04

Study design

Time perspective
Prospective
Enrollment
21 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 months

Secondary outcomes

  1. 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

    Time frame: 5 months

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT02048449
Lead sponsor
Chuncheon Sacred Heart Hospital
Responsible party
Yeonsoo Kim (Assistant professor, Chuncheon Sacred Heart Hospital) — Principal investigator
First posted
Jan 29, 2014
Start date
Jan 2014
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Apr 7, 2014

Study contacts

Dong Kyu Kim, MD
study director · Assistant professor, ENT department, Chuncheon Sacred Heart Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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