POST-RADIOIODINE GRAVES' MANAGEMENT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 803
- 试验地点
- 1
- 主要终点
- Incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK
时间窗: 12 months post radio-iodine
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.
次要结局
- weight gain(12 months)
- progression of Graves' orbitopathy(12 months)
- Graves orbitopathy(12 months post-radiodiodine)
- patient satisfaction(12 months)