NCT02048449

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

January 21, 2014

Last Update Submit

April 4, 2014

Conditions

LaryngitisReflux

Keywords

Reflux finding score, interrater reliability

Outcome Measures

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

    5 months

Secondary Outcomes (1)

  • Agreement (%) at each item out of 8 items of reflux finding score

    5 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

not appliable

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LaryngitisGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Dong Kyu Kim, MD

    Assistant professor, ENT department, Chuncheon Sacred Heart Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 29, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 7, 2014

Record last verified: 2014-04