Inter-rater Reliability of the Reflux Finding Score Among... | NCT02048449

Studies
Inter-rater Reliability of the Reflux Finding Score Among Gastroenterologists

NCT02048449

Sponsor

Chuncheon Sacred Heart Hospital

Status

Completed

Last Update Posted

Apr 7, 2014Estimated

Enrollment

21Actual

Phase

Not provided

Conditions

Laryngitis
Reflux

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jan 21, 2014

First Submission Date that Met QC Criteria

Jan 28, 2014

First Posted Date

Jan 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2014

Last Update Posted Date

Apr 7, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yeonsoo Kim, Assistant professor, Chuncheon Sacred Heart HospitalPrincipal Investigator

Lead Sponsor

Chuncheon Sacred Heart HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

Study Design

Recruitment of doctor participants: introduction by e-mail
Education on reflux finding score - standardized materials (instructional video)
PRETEST (15 pictures) / feedback (at-a-glance assessment format)
TEST 1 (50 pictures) - Acess format including 8 items at each pictures
Feedback education (individualized intruction of an otorhinolaryngologist)
TEST 2 (50 pictures) - Acess format including 8 items at each pictures
Test-Retest reliability - repeat Test 2 with 1 week interval (Participants should take retest of TEST 2 with the concealment of the answer)
Analysis

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

not appliable

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dong Kyu Kim, MD	Assistant professor, ENT department, Chuncheon Sacred Heart Hospital	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007827	Laryngitis
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D007818	Laryngeal Diseases
D012140	Respiratory Tract Diseases

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