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NCT00797732 · OUTCOME

MDADI Scores

A Pilot Study of Acupuncture Treatment for Dysphagia · Source last updated 2018-02-13

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture

What was measured

The M.D. Anderson Dysphagia Inventory (MDADI) is a validated, self-administered questionnaire established as the best measure of dysphagia-related quality of life in HNC patients. (Carlsson S, et al Dysphagia 2012; 27: 361-369). MDADI has two summary scores: 1) global (1 item) and 2) composite (19 items). Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score is a weighted average of the physical, emotional, and functional subscale questions. Scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). A minimal clinically important within group difference was a 10% change from baseline.

Analysis population: The analysis population is comprised of all randomized participants. At each timepoint, a subset of participants were evaluable for quality of life assessment.

Groups in this outcome

Active Acupuncture

Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.

Sham Acupuncture

Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.

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

Analysis denominator · Participants

GroupSource count
Active Acupuncture21
Sham Acupuncture21

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Active Acupuncture18
Sham Acupuncture18
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Active Acupuncture60.314.7Not reportedNot reportedNot reported
Sham Acupuncture69.215.5Not reportedNot reportedNot reported
20 weeks post chemoradiation start

Analysis denominator · Participants

GroupSource count
Active Acupuncture17
Sham Acupuncture18
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Active Acupuncture68.713.3Not reportedNot reportedNot reported
Sham Acupuncture77.810.9Not reportedNot reportedNot reported
6 months post acupuncture start

Analysis denominator · Participants

GroupSource count
Active Acupuncture16
Sham Acupuncture18
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Active Acupuncture72.713.3Not reportedNot reportedNot reported
Sham Acupuncture79.312.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.7
        value
        60.3
      2. group Id
        OG001
        spread
        15.5
        value
        69.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.3
        value
        68.7
      2. group Id
        OG001
        spread
        10.9
        value
        77.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    20 weeks post chemoradiation start
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.3
        value
        72.7
      2. group Id
        OG001
        spread
        12.4
        value
        79.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    6 months post acupuncture start
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      21
    units
    Participants
description
The M.D. Anderson Dysphagia Inventory (MDADI) is a validated, self-administered questionnaire established as the best measure of dysphagia-related quality of life in HNC patients. (Carlsson S, et al Dysphagia 2012; 27: 361-369). MDADI has two summary scores: 1) global (1 item) and 2) composite (19 items). Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score is a weighted average of the physical, emotional, and functional subscale questions. Scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). A minimal clinically important within group difference was a 10% change from baseline.
dispersion Type
Standard Deviation
groups
  1. description
    Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
    id
    OG000
    title
    Active Acupuncture
  2. description
    Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
    id
    OG001
    title
    Sham Acupuncture
param Type
MEAN
population Description
The analysis population is comprised of all randomized participants. At each timepoint, a subset of participants were evaluable for quality of life assessment.
reporting Status
POSTED
time Frame
Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture
title
MDADI Scores
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice