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NCT00346164 · OUTCOME

Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma · Source last updated 2022-04-28

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
At Diagnosis

What was measured

Histologic grades were determined by the central pathology reviewers and institutional pathologists based on published standards. A higher grade is associated with a more severe disease.

Analysis population: Ineligible patients, as well as patients without histologic grade determined by enrolling institution or central pathology reviewers were excluded. The OM evaluates the degree of agreement of two pathology grading reviews at diagnosis. The time frame "At diagnosis" reflects the OM.

Groups in this outcome

Histologic Grade 1 by Enrolling Institution

Not reported

Histologic Grade 2 by Enrolling Institution

Not reported

Histologic Grade 3 by Enrolling Institution

Not reported

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

Analysis denominator · Participants

GroupSource count
Histologic Grade 1 by Enrolling Institution45
Histologic Grade 2 by Enrolling Institution71
Histologic Grade 3 by Enrolling Institution278

Reported measurements

Histologic grade 1 by central pathology reviewers
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Histologic Grade 1 by Enrolling Institution38Not reportedNot reportedNot reportedNot reported
Histologic Grade 2 by Enrolling Institution5Not reportedNot reportedNot reportedNot reported
Histologic Grade 3 by Enrolling Institution1Not reportedNot reportedNot reportedNot reported
Histologic grade 2 by central pathology reviewers
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Histologic Grade 1 by Enrolling Institution4Not reportedNot reportedNot reportedNot reported
Histologic Grade 2 by Enrolling Institution56Not reportedNot reportedNot reportedNot reported
Histologic Grade 3 by Enrolling Institution9Not reportedNot reportedNot reportedNot reported
Histologic grade 3 by central pathology reviewers
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Histologic Grade 1 by Enrolling Institution3Not reportedNot reportedNot reportedNot reported
Histologic Grade 2 by Enrolling Institution10Not reportedNot reportedNot reportedNot reported
Histologic Grade 3 by Enrolling Institution268Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.88
    group Description
    Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    OTHER
    param Type
    Kappa statistic
    param Value
    0.82
Complete source fields
analyses
  1. ci Lower Limit
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.88
    group Description
    Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    OTHER
    param Type
    Kappa statistic
    param Value
    0.82
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        1
    title
    Histologic grade 1 by central pathology reviewers
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        56
      3. group Id
        OG002
        value
        9
    title
    Histologic grade 2 by central pathology reviewers
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        268
    title
    Histologic grade 3 by central pathology reviewers
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    2. group Id
      OG001
      value
      71
    3. group Id
      OG002
      value
      278
    units
    Participants
description
Histologic grades were determined by the central pathology reviewers and institutional pathologists based on published standards. A higher grade is associated with a more severe disease.
groups
  1. id
    OG000
    title
    Histologic Grade 1 by Enrolling Institution
  2. id
    OG001
    title
    Histologic Grade 2 by Enrolling Institution
  3. id
    OG002
    title
    Histologic Grade 3 by Enrolling Institution
param Type
NUMBER
population Description
Ineligible patients, as well as patients without histologic grade determined by enrolling institution or central pathology reviewers were excluded. The OM evaluates the degree of agreement of two pathology grading reviews at diagnosis. The time frame "At diagnosis" reflects the OM.
reporting Status
POSTED
time Frame
At Diagnosis
title
Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice