TriangleNCT00797732 · OUTCOME
MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)
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
- 95% Confidence Interval
- Time frame
- Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT
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 represents the subset of participants evaluable at baseline and 12 months post CRT/6 months post acupuncture
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 | Source count |
|---|---|
| Active Acupuncture | 16 |
| Sham Acupuncture | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Active Acupuncture | 7.9 | Not reported | 0.2 | 15.6 | Not reported |
| Sham Acupuncture | 13.9 | Not reported | 6.4 | 21.4 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- .17
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- .17
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 15.6
- value
- 7.9
- group Id
- OG001
- lower Limit
- 6.4
- upper Limit
- 21.4
- value
- 13.9
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 18
- 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
- 95% Confidence Interval
- groups
- 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
- 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 represents the subset of participants evaluable at baseline and 12 months post CRT/6 months post acupuncture
- reporting Status
- POSTED
- time Frame
- Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT
- title
- MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice