Pilot Study of Ultrasound in Rheumatoid Arthritis
A Pilot Study of Musculoskeletal Ultrasound Assessment in Patients With Rheumatoid Arthritis
Little is currently known as to the predictive value of ultrasound in guiding the decision to taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that patients' views and opinions regarding their medications may have upon this. In this study, patients with stable rheumatoid arthritis will undergo a simple examination of their joints to look for any swelling or tenderness followed by an ultrasound scan to look for joint inflammation. Half of the patients will also complete an interview to assess their views and opinions of arthritis drug treatment. The study will be completed in a single patient visit - no invasive tests will be performed, and no changes to treatment will be made.
This study is being conducted as part of a Masters degree from Newcastle University. The results of this study will be used to inform the feasibility of inclusion of ultrasound assessment within the design of a future PhD study to investigate potential markers of remission in patients with rheumatoid arthritis.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Newcastle upon Tyne、英国、NE7 7DN
- Musculoskeletal Outpatient Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Diagnosis of rheumatoid arthritis with symptom onset at least 12 months previously
- Current disease-modifying anti-rheumatic drug (DMARD) therapy or biologic therapy
- Currently stable arthritis defined as no change in DMARD treatment over previous 6 months, and no use of steroids (enteral, parenteral or intra-articular) over previous 6 months
Exclusion Criteria:
- Inability to provide informed consent
- Current or recent (within 4 months) participation within another clinical trial
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Observational study group
Musculoskeletal ultrasound (all patients) and semi-structured patient interview (anticipated maximum 15 patients)
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7-joint musculoskeletal ultrasound scan
Semi-structured patient interview
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis score
大体时间：At recruitment
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Defined as Kappa statistic of at least 0.4.
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At recruitment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Qualitative data relating to patients' views and opinions of their arthritis medication
大体时间：At recruitment
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Based upon data collected by a semi-structured interview approach and analysed using standard qualitative techniques.
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At recruitment
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Simplified Disease Activity Index (SDAI)
大体时间：At recruitment
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At recruitment
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Disease Activity Score in 28 joints (DAS-28)
大体时间：At recruitment
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At recruitment
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Disease Activity Score (DAS)
大体时间：At recruitment
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At recruitment
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合作者和调查者
调查人员
- 首席研究员：John D Isaacs, PhD, MB BS、Newcastle University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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