Health-Related Quality of Life for Thyroid Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150033
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : May 22, 2008
Rigshospitalet, Denmark
University of Copenhagen
Information provided by:
Odense University Hospital

Brief Summary:


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.


To develop and evaluate a questionnaire to measure health-related quality of life in patients suffering from thyroid diseases.


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).


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.

Condition or disease
Thyroid Diseases

Study Type : Observational
Estimated Enrollment : 1200 participants
Time Perspective: Prospective
Official Title: Development and Validation of a Thyroid-Specific Quality of Life Measure
Study Start Date : May 2005
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150033

Department of Endocrinology, Rigshospitalet
Copenhagen, Sealand, Denmark, 2100
Sponsors and Collaborators
Odense University Hospital
Rigshospitalet, Denmark
University of Copenhagen
Principal Investigator: Torquil Watt, MD Rigshospitalet, Denmark
Study Director: Ulla Feldt-Rasmussen, MD, DMSc Copenhagen University Hospital

Publications of Results:
Other Publications:
Responsible Party: Torquil Watt, MD, Copenhagen University Hospital Rigshospitalet Identifier: NCT00150033     History of Changes
Other Study ID Numbers: 011
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: May 22, 2008
Last Verified: May 2008

Keywords provided by Odense University Hospital:
thyroid disease
Quality of Life
Patient reported outcome
Quality of Life measurement

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases