LaryngitisNCT02048449
Inter-rater Reliability of the Reflux Finding Score Among Gastroenterologists
An observational study of Laryngitis and Reflux, run by Chuncheon Sacred Heart Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laryngitis, Reflux
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: not appliable
Who may be able to join
- Participants: Gastroenterologists (GI specialists) or trainees /
- Pictures: Endoscopic laryngeal pictures with good quality
Who cannot join
- Participants: Major other than gastroenterology /
- Pictures: Endoscopic laryngeal pictures without good quality
About this study
Official title: 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
Read more
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
- 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
- Conditions
- Laryngitis, Reflux
- Keywords
- Reflux finding score, interrater reliability
- Medical subject headings
- Laryngitis, Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeonsoo Kim, Chuncheon Sacred Heart Hospital
- Investigators
- Dong Kyu Kim, MD, Study director, Assistant professor, ENT department, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048449
- Sponsor's protocol ID
- ChuncheonSHH 2013
- Status last verified
- Apr 2014
- First submitted
- 21 Jan 2014
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-rater Reliability of the Reflux Finding Score Based on Endoscopic Laryngeal Findings in the Diagnosis of Laryngopharyngeal Reflux Disease
- ClinicalTrials.gov ID
- NCT02048449
- Acronym / sponsor ID
- ChuncheonSHH 2013
- Conditions
- Laryngitis, Reflux
- Keywords
- Reflux finding score, interrater reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- not appliable
Key inclusion criteria (2 listed)
- Participants: Gastroenterologists (GI specialists) or trainees /
- Pictures: Endoscopic laryngeal pictures with good quality
Key exclusion criteria (2 listed)
- Participants: Major other than gastroenterology /
- Pictures: Endoscopic laryngeal pictures without good quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Agreement (%) at each item out of 8 items of reflux finding score
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
Related trials for Laryngitis
RecruitingObservational study
Complicated Infections in Otorhinolaryngology
Sinusitis, Otitis
Recruiting
Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care
Angina, Acute Bronchiolitis
RecruitingPhase 3
VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma
Asthma, Respiratory Tract Infections
RecruitingPhase 3
Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma
Asthma, Respiratory Tract Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Kyu Kim, MD study director
Assistant professor, ENT department, Chuncheon Sacred Heart Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngitis and Reflux, run by Chuncheon Sacred Heart Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohen's kappa coefficient (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.