Construct Validity and Responsiveness of EQ-5D-3L and EQ-5D-5L in Patients With Inflammatory Joint Disease
2026年5月5日 更新者：Emelie Heintz、Karolinska Institutet
The aim of this study is to compare the construct validity (convergent validity and known-groups validity) and responsiveness of EQ-5D-3L and EQ-5D-5L in patients with inflammatory joint disease.
The study is based on prospectively collected data through the Swedish Rheumatology Quality Register (SRQ).
研究概览
详细说明
A detailed description of the study can be found in the uploaded document titled 'Study Protocol and Statistical Analysis Plan.'
研究类型
观察性的
注册 (实际的)
6967
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Stockholm、瑞典
- Karolinska Institutet
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Patients with inflammatory joint disease complete PROMs routinely in conjunction with their follow-up healthcare visits, through an online platform called Patients Own Registration (PER).
Patients who meet the inclusion criteria will be asked whether they want to participate in the study when they access PER.
描述
Inclusion Criteria:
- Agreed to participate in the study
- ≥18 years at the time of the first measurement
- A diagnosis of rheumatoid arthritis (RA), polyarthritis, psoriatic arthritis (PsA), or ankylosing spondylitis (AS)
- Complete registration of responses in the EQ-5D-3L and EQ-5D-5L descriptive system at least at one time point (one visit)
- For patients with RA: At least one measurement with Disease Activity Score 28 (DAS28) reported in relation to the same visit as the EQ-5D was registered
- For patients with polyarthritis: At least one measurement with DAS28 reported in relation to the same visit as the EQ-5D was registered
- For patients with PsA: At least one measurement with DAS28 or Disease Activity in Psoriatic Arthritis (DAPSA) reported in relation to the same visit as the EQ-5D was registered
- For patients with AS: At least one measurement with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or the Axial Spondyloarthritis Disease Activity Score (ASDAS) reported in relation to the same visit as the EQ-5D was registered
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
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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EQ-5D-3L
大体时间：Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
Instrument used to measure and value health-related quality of life.
The instrument consists of five items/dimensions that can be answered from 1-3.
A higher score indicates more problems.
The responses to the items can be recalculated into an index value where 1 indicates full health and 0 a state considered equivalent to being dead.
|
Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
|
EQ-5D-5L
大体时间：Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
Instrument used to measure and value health-related quality of life.
The instrument consists of five items/dimensions that can be answered from 1-5.
A higher score indicates more problems.
The responses to the items can be recalculated into an index value where 1 indicates full health and 0 a state considered equivalent to being dead.
|
Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
|
Disease activity score 28 (DAS28)
大体时间：Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
Measure of disease activity.
0 indicates no disease activity and 10 indicates the highest disease activity.
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Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
大体时间：Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
Measure of disease activity.
0 indicates no disease activity and 10 highest disease activity.
|
Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
|
Ankylosing Spondylitis Disease Activity Score (ASDAS)
大体时间：Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
Measure of disease activity.
0 indicates no disease activity.
There is no upper limit, but a higher score indicates higher disease activity.
|
Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
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|
Health Assessment Questionnaire Disability Index (HAQ-DI)
大体时间：Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
Measure of physical function.
Ranges between 0 and 3. A higher score indicates more problems with physical function.
|
Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
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Bath Ankylosing Spondylitis Functional Index (BASFI)
大体时间：Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
Measure of physical function.
Ranges between 0 and 10.
A higher score indicates more problems with physical function.
|
Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
|
Pain measured with a visual analogue scale
大体时间：Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
Visual analogue scale measuring pain.
0 indicates no pain and 100 indicates the worst possible pain.
|
Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
|
Fatigue measured with a visual analogue scale
大体时间：Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
Visual analogue scale measuring fatigue.
0 indicates no problem with fatigue and 100 indicates the worst possible fatigue.
|
Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
|
General health measured with a visual analogue scale
大体时间：Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
Visual analogue scale measuring general health.
0 indicates no problems with general health and 100 indicates worst possible general health.
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Established disease: Baseline at inclusion in the study and the next health care visit within the study period (nov 23 - mar 26). Newly diagnosed disease: At baseline and at every health care visit throughout study completion (nov 23 - mar 26).
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, Lloyd A, Scalone L, Kind P, Pickard AS. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012 Jul-Aug;15(5):708-15. doi: 10.1016/j.jval.2012.02.008. Epub 2012 May 24.
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- Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.
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- Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995 Jan;38(1):44-8. doi: 10.1002/art.1780380107.
- Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P, Jenkinson T. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 1994 Dec;21(12):2281-5.
- Lukas C, Landewe R, Sieper J, Dougados M, Davis J, Braun J, van der Linden S, van der Heijde D; Assessment of SpondyloArthritis international Society. Development of an ASAS-endorsed disease activity score (ASDAS) in patients with ankylosing spondylitis. Ann Rheum Dis. 2009 Jan;68(1):18-24. doi: 10.1136/ard.2008.094870. Epub 2008 Jul 14.
- Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018 May;27(5):1147-1157. doi: 10.1007/s11136-018-1798-3. Epub 2018 Feb 12.
- Fransen J, van Riel PL. The Disease Activity Score and the EULAR response criteria. Rheum Dis Clin North Am. 2009 Nov;35(4):745-57, vii-viii. doi: 10.1016/j.rdc.2009.10.001.
- Aletaha D, Smolen JS. The Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) to monitor patients in standard clinical care. Best Pract Res Clin Rheumatol. 2007 Aug;21(4):663-75. doi: 10.1016/j.berh.2007.02.004.
- Boonen A, van der Heijde D, Landewe R, van Tubergen A, Mielants H, Dougados M, van der Linden S. How do the EQ-5D, SF-6D and the well-being rating scale compare in patients with ankylosing spondylitis? Ann Rheum Dis. 2007 Jun;66(6):771-7. doi: 10.1136/ard.2006.060384. Epub 2007 Jan 9.
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- Nell-Duxneuner VP, Stamm TA, Machold KP, Pflugbeil S, Aletaha D, Smolen JS. Evaluation of the appropriateness of composite disease activity measures for assessment of psoriatic arthritis. Ann Rheum Dis. 2010 Mar;69(3):546-9. doi: 10.1136/ard.2009.117945. Epub 2009 Sep 17.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年11月30日
初级完成 (实际的)
2026年3月5日
研究完成 (实际的)
2026年3月5日
研究注册日期
首次提交
2026年4月21日
首先提交符合 QC 标准的
2026年5月5日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年5月12日
上次提交的符合 QC 标准的更新
2026年5月5日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.