Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150033
Status:
COMPLETED
Last Update Posted:
2008-05-22
First Post:
2005-09-06
Brief Title:
Health-Related Quality of Life for Thyroid Patients
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Development and Validation of a Thyroid-Specific Quality of Life Measure
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Thyroid diseases are frequent They include both metabolic changes and gland enlargement goitre Previous research and clinical suspicion indicate that the life quality of many patients is reduced despite successful treatment Research methods are however weak and a well-tested disease specific quality of life questionnaire is especially needed Several treatment possibilities exist for each thyroid disease For example hypermetabolism can be treated with either medication radioactive iodine or by surgery No comparative studies of quality of life using the different treatment modalities exist
Purpose
To develop and evaluate a questionnaire to measure health-related quality of life in patients suffering from thyroid diseases
Methods
To ensure that all relevant aspects are included the questionnaire will be developed on the basis of a systematic examination of the scientific literature and interviews with 13 physicians and 100 patients The questionnaire will then be tested by 100 new patients After revision the questionnaire will be answered by 1000 patients with a view to scientifically investigate the measuring capacity of the questionnaire This will be done using traditional psychology methods psychometry as well as modern statistical methods structural equations for categorical data and item response models
Relevance
The above-mentioned questionnaire is necessary for clarifying whether these diseases reduce quality of life and in the long-term whether a difference in quality of life exists using the different treatment alternatives and whether treatment can be improved It should also be included in quality protection studies in the evaluation of new treatment modalities and possibly also in the treatment of the individual patient
Thyroid diseases are frequent They include both metabolic changes and gland enlargement goitre Previous research and clinical suspicion indicate that the life quality of many patients is reduced despite successful treatment Research methods are however weak and a well-tested disease specific quality of life questionnaire is especially needed Several treatment possibilities exist for each thyroid disease For example hypermetabolism can be treated with either medication radioactive iodine or by surgery No comparative studies of quality of life using the different treatment modalities exist
Purpose
To develop and evaluate a questionnaire to measure health-related quality of life in patients suffering from thyroid diseases
Methods
To ensure that all relevant aspects are included the questionnaire will be developed on the basis of a systematic examination of the scientific literature and interviews with 13 physicians and 100 patients The questionnaire will then be tested by 100 new patients After revision the questionnaire will be answered by 1000 patients with a view to scientifically investigate the measuring capacity of the questionnaire This will be done using traditional psychology methods psychometry as well as modern statistical methods structural equations for categorical data and item response models
Relevance
The above-mentioned questionnaire is necessary for clarifying whether these diseases reduce quality of life and in the long-term whether a difference in quality of life exists using the different treatment alternatives and whether treatment can be improved It should also be included in quality protection studies in the evaluation of new treatment modalities and possibly also in the treatment of the individual patient
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None