Institute of Health & Society, Newcastle University, Newcastle upon Tyne NE2 4AX, UK.
Trials. 2013 Mar 22;14:83. doi: 10.1186/1745-6215-14-83.
The population of the UK is ageing. There is compelling evidence that thyroid stimulating hormone distribution levels increase with age. Currently, in UK clinical practice elderly hypothyroid patients are treated with levothyroxine to lower their thyroid stimulating hormone levels to a standard non-age-related range. Evidence suggests that mortality is negatively associated with thyroid stimulating hormone levels. We report the protocol of a feasibility study working towards a full-scale randomized controlled trial to test whether lower dose levothyroxine has beneficial cardiovascular outcomes in the oldest old.
METHODS/DESIGN: SORTED is a mixed methods study with three components: SORTED A: A feasibility study of a dual-center single-blinded randomized controlled trial of elderly hypothyroid patients currently treated with levothyroxine.
Patients will be recruited from 20 general practices and two hospital trust endocrine units in Northumberland, Tyne and Wear.
Target recruitment of 50 elderly hypothyroid patients currently treated with levothyroxine, identified in both primary and secondary care settings.
Reduced dose of levothyroxine to achieve an elevated serum thyroid stimulating hormone (target range 4.1 to 8.0 mU/L) versus standard levothyroxine replacement (target range 0.4 to 4.0 mU/L).
Using random permuted blocks, in a ratio of 1:1, randomization will be carried out by Newcastle Clinical Trials Unit.
Study feasibility (recruitment and retention rates and medication compliance), acceptability of the trial design, assessment of mobility and falls risk, and change in cardiovascular risk factors.
Qualitative study using in-depth interviews to understand patients' willingness to take part in a randomized controlled trial and participants' experience of the intervention.
Retrospective cohort study of 400 treated hypothyroid patients aged 80 years or over registered in 2008 in primary care practices, studying their 4-year cardiovascular outcomes to inform the power of SORTED II.
This is a study to evaluate the feasibility of conducting a randomized controlled trial in elderly hypothyroid patients in general practice and hospital settings. The results will inform the design of the definitive SORTED II trial to evaluate the effects of lower dose thyroxine in elderly hypothyroid patients.
Current Controlled Trials ISRCTN16043724.
英国人口老龄化。有确凿证据表明，甲状腺刺激激素的分布水平随年龄增长而升高。目前，在英国临床实践中，老年甲状腺功能减退症患者接受左甲状腺素治疗，以将其甲状腺刺激激素水平降低至非年龄相关的标准范围。有证据表明，死亡率与甲状腺刺激激素水平呈负相关。我们报告了一项可行性研究的方案，该研究旨在进行一项全面的随机对照试验，以测试老年甲状腺功能减退症患者使用较低剂量左甲状腺素是否对心血管有有益的结果。
方法/设计：SORTED 是一项混合方法研究，包括三个部分：SORTED A：一项对目前接受左甲状腺素治疗的老年甲状腺功能减退症患者进行的双中心单盲随机对照试验的可行性研究。
将从诺森伯兰郡、泰恩和威尔的 20 个普通诊所和两个医院信托内分泌单位招募患者。
目标招募 50 名目前接受左甲状腺素治疗的老年甲状腺功能减退症患者，这些患者在初级和二级保健环境中均有发现。
降低左甲状腺素剂量以达到升高的血清甲状腺刺激激素（目标范围 4.1 至 8.0 mU/L）与标准左甲状腺素替代（目标范围 0.4 至 4.0 mU/L）。
纽卡斯尔临床试验单位将采用随机排列块，以 1:1 的比例进行随机化。
研究可行性（招募和保留率以及药物依从性）、试验设计的可接受性、移动性和跌倒风险评估以及心血管危险因素的变化。
使用深入访谈的定性研究，以了解患者参与随机对照试验的意愿和参与者对干预措施的体验。
对 2008 年在初级保健诊所登记的 400 名 80 岁或以上的治疗性甲状腺功能减退症患者进行回顾性队列研究，研究他们 4 年的心血管结局，为 SORTED II 提供信息。
这是一项在普通诊所和医院环境中评估老年甲状腺功能减退症患者进行随机对照试验可行性的研究。研究结果将为 SORTED II 试验的设计提供信息，以评估老年甲状腺功能减退症患者使用较低剂量甲状腺素的效果。
当前对照试验 ISRCTN85210118。
