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Health-Related Quality of Life for Thyroid Patients

Development and Validation of a Thyroid-Specific Quality of Life Measure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00150033
Enrollment
1200
Registered
2005-09-08
Start date
2005-05-31
Completion date
2007-10-31
Last updated
2008-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Diseases

Keywords

thyroid disease, Quality of Life, Patient reported outcome, questionnaire, Quality of Life measurement

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.

Interventions

None listed

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER
Odense University Hospital
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients with benign thyroid disease.

Exclusion criteria

* Unable to complete questionnaire: must be able to read and write Danish

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026