Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1200 participants
OBSERVATIONAL
2005-05-31
2007-10-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
15 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
University of Copenhagen
OTHER
Odense University Hospital
OTHER
Responsible Party
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Copenhagen University Hospital Rigshospitalet
Principal Investigators
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Torquil Watt, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Ulla Feldt-Rasmussen, MD, DMSc
Role: STUDY_DIRECTOR
Copenhagen University Hospital at Herlev
Locations
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Department of Endocrinology, Rigshospitalet
Copenhagen, Sealand, Denmark
Countries
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References
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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.
Other Identifiers
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011
Identifier Type: -
Identifier Source: org_study_id