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NCT01456143 · OUTCOME

Interrater Reliability

Optical Imaging of Head and Neck Cancer · Source last updated 2018-02-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
proportion of agreement among 11 experts
Interval / dispersion
95% Confidence Interval
Time frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)

What was measured

Amount of agreement among the 11 blinded head and neck cancer specialists, determined by the Fleiss Kappa. 33 benign and 65 cancer images were evaluated by the reviewers who were blinded to the anatomical site, tumor subsite, and final histopathologic diagnosis. Each reviewer was asked to classify each image as benign or neoplastic. The reviewers evaluated the images based on nuclear size, nuclear to cytoplasmic ratio, and overall cell architecture. Images were randomized in their presentation to the reviewers as to not establish any pattern. Each reviewer provided their interpretation in isolated settings to avoid influence from other reviewers.

Groups in this outcome

HRME With Proflavine

High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
HRME With Proflavine33

Reported measurements

Source class 1
Values in proportion of agreement among 11 experts · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HRME With Proflavine.81Not reported.78.84Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        .78
        upper Limit
        .84
        value
        .81
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Amount of agreement among the 11 blinded head and neck cancer specialists, determined by the Fleiss Kappa. 33 benign and 65 cancer images were evaluated by the reviewers who were blinded to the anatomical site, tumor subsite, and final histopathologic diagnosis. Each reviewer was asked to classify each image as benign or neoplastic. The reviewers evaluated the images based on nuclear size, nuclear to cytoplasmic ratio, and overall cell architecture. Images were randomized in their presentation to the reviewers as to not establish any pattern. Each reviewer provided their interpretation in isolated settings to avoid influence from other reviewers.
dispersion Type
95% Confidence Interval
groups
  1. description
    High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
    id
    OG000
    title
    HRME With Proflavine
param Type
NUMBER
reporting Status
POSTED
time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
title
Interrater Reliability
type
PRIMARY
unit Of Measure
proportion of agreement among 11 experts

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice