- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00150033
Health-Related Quality of Life for Thyroid Patients
Development and Validation of a Thyroid-Specific Quality of Life Measure
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Sealand
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Copenhagen, Sealand, Denmark, 2100
- Department of Endocrinology, Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients with benign thyroid disease.
Exclusion Criteria:
- Unable to complete questionnaire: must be able to read and write Danish
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Torquil Watt, MD, Rigshospitalet, Denmark
- Study Director: Ulla Feldt-Rasmussen, MD, DMSc, Copenhagen University Hospital at Herlev
Publications and helpful links
General Publications
- Watt T, Groenvold M, Rasmussen AK, Bonnema SJ, Hegedus L, Bjorner JB, Feldt-Rasmussen U. Quality of life in patients with benign thyroid disorders. A review. Eur J Endocrinol. 2006 Apr;154(4):501-10. doi: 10.1530/eje.1.02124.
- Watt T, Hegedus L, Rasmussen AK, Groenvold M, Bonnema SJ, Bjorner JB, Feldt-Rasmussen U. Which domains of thyroid-related quality of life are most relevant? Patients and clinicians provide complementary perspectives. Thyroid. 2007 Jul;17(7):647-54. doi: 10.1089/thy.2007.0069.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 011
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