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NCT04172467 · OUTCOME

Guideline Adherence (GLAD)

Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients · Source last updated 2022-01-10

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Median study observation period of 18.2 months

What was measured

For SID, immunoglobulin substitution (IgRT) is mandatory only for patients with an IgG level \< 4g/l (or IgG subclass deficiency) and additionally more than 3 infections or a severe infection (≥ grade 3) and is optional (may be appropriate) if IgG level \< 4g/l and/or 1-3 less severe infections (≤ grade 2). IgRT is not indicated if patients do not fulfil either condition. Scoring system: GLAD-Score 2: full guideline adherence GLAD-Score 1: deviations in dose or interval (+/- 10%) or a late start of IgRT (\>28 days after a severe infection (≥ grade 3). GLAD-Score 0: IgRT without indication (overuse) or omitted IgRT despite recommendation (underuse). Likewise, 0 points were awarded if both the dose and the interval deviated from the GL recommendations (e.g. underdosed single dose) or if IgRT was not started until more than 3 months after hypogammaglobulinemia and at least one severe infection.

Groups in this outcome

Non-interventional Retrospective Observational Study.

This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analysed.

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

Analysis denominator · Participants

GroupSource count
Non-interventional Retrospective Observational Study.1086

Reported measurements

Source class 1

GLAD-Score 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-interventional Retrospective Observational Study.889Not reportedNot reportedNot reportedNot reported

GLAD-Score 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-interventional Retrospective Observational Study.75Not reportedNot reportedNot reportedNot reported

GLAD-Score 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-interventional Retrospective Observational Study.122Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        889
      title
      GLAD-Score 2
    2. measurements
      1. group Id
        OG000
        value
        75
      title
      GLAD-Score 1
    3. measurements
      1. group Id
        OG000
        value
        122
      title
      GLAD-Score 0
denoms
  1. counts
    1. group Id
      OG000
      value
      1086
    units
    Participants
description
For SID, immunoglobulin substitution (IgRT) is mandatory only for patients with an IgG level \< 4g/l (or IgG subclass deficiency) and additionally more than 3 infections or a severe infection (≥ grade 3) and is optional (may be appropriate) if IgG level \< 4g/l and/or 1-3 less severe infections (≤ grade 2). IgRT is not indicated if patients do not fulfil either condition. Scoring system: GLAD-Score 2: full guideline adherence GLAD-Score 1: deviations in dose or interval (+/- 10%) or a late start of IgRT (\>28 days after a severe infection (≥ grade 3). GLAD-Score 0: IgRT without indication (overuse) or omitted IgRT despite recommendation (underuse). Likewise, 0 points were awarded if both the dose and the interval deviated from the GL recommendations (e.g. underdosed single dose) or if IgRT was not started until more than 3 months after hypogammaglobulinemia and at least one severe infection.
groups
  1. description
    This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analysed.
    id
    OG000
    title
    Non-interventional Retrospective Observational Study.
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Median study observation period of 18.2 months
title
Guideline Adherence (GLAD)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice