Post-Radioiodine Graves' Management: The PRAGMA-Study

Study Overview
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Brief Summary
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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.

Official Title
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POST-RADIOIODINE GRAVES' MANAGEMENT

Conditions
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Graves' Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-radioiodine medication<br>Anti-thyroid drugs | |
| Post-radioiodine medications<br>anti-thyroid drugs and thyroxine | |
| Post-radiodione medication<br>watchful monitoring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK | To compare the incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK: anti-thyroid drugs before and /or after RI anti-thyroid drugs with levothyroxine before and / or after RI watchful monitoring post-RI and introduction of levothyroxine when needed. | 12 months post radio-iodine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graves orbitopathy |  | 12 months post-radiodiodine | 
| weight gain |  | 12 months | 
| progression of Graves' orbitopathy |  | 12 months | 
| patient satisfaction |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graves' disease, radioiodine, thyroid, hypothyroidism, Graves' orbitopathy