Post-Radioiodine Graves' Management: The PRAGMA-Study

Newcastle-upon-Tyne Hospitals NHS Trust

Status

Completed

Conditions

Graves' Disease

Study type

Observational

Funder types

Other

Identifiers

NCT01885533

110269

Details and patient eligibility

About

Thyroid dysfunction following radioiodine for Graves' disease is common, potentially detrimental and avoidable. A variety of clinical strategies are employed in the post-radioiodine era util the patient is on a stable thyroid hormone replacement regimen, which include the use of anti-thyroid drugs, antithyroid drugs with thyroxine, early thyroxine replacement and watchful monitoring until the onset of hypothyroidism. Which of these is most effective in avoiding dysthyroidism, is unknown. This study aims to address this lack of evidence. It will focus on Graves' disease as this is the commonest cause of thyrotoxicosis and the commonest indication for RI therapy. It will provide an insight into potential strategies for improving important clinical outcomes.

Enrollment

803 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Out-patients 18 years of age or over, who have given written informed consent to participate in the study
Diagnosed with Graves' disease
Received radioiodine for treatment of Graves' disease
Had a minimum of 12 months follow-up after RI
Most recent RI dose 5 years ago or less at the time of enrollment

Exclusion criteria

Patients unable to give informed consent
Age 17 years or younger
Cause of thyrotoxicosis other than Graves' disease
Patients who have had more than one dose of radioiodine can only be included in the study once, using data pertaining to their most recent treatment episode.
Patients who might not adequately understand verbal explanations or written information given in English, or who have special communication needs