Construct Validity and Responsiveness of EQ-5D-3L and EQ-5D-5L in Patients With Inflammatory Joint Disease
2026년 5월 5일 업데이트: 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).
연구 개요
상세 설명
A detailed description of the study can be found in the uploaded document titled 'Study Protocol and Statistical Analysis Plan.'
연구 유형
관찰
등록 (실제)
6967
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Stockholm, 스웨덴
- Karolinska Institutet
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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EQ-5D-3L
기간: 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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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.
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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).
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EQ-5D-5L
기간: 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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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.
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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).
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Disease activity score 28 (DAS28)
기간: 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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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).
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
기간: 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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Measure of disease activity.
0 indicates no disease activity and 10 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).
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Ankylosing Spondylitis Disease Activity Score (ASDAS)
기간: 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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Measure of disease activity.
0 indicates no disease activity.
There is no upper limit, but a higher score indicates higher 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).
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Health Assessment Questionnaire Disability Index (HAQ-DI)
기간: 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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Measure of physical function.
Ranges between 0 and 3. A higher score indicates more problems with physical function.
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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).
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Bath Ankylosing Spondylitis Functional Index (BASFI)
기간: 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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Measure of physical function.
Ranges between 0 and 10.
A higher score indicates more problems with physical function.
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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).
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Pain measured with a visual analogue scale
기간: 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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Visual analogue scale measuring pain.
0 indicates no pain and 100 indicates the worst possible pain.
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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).
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Fatigue measured with a visual analogue scale
기간: 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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Visual analogue scale measuring fatigue.
0 indicates no problem with fatigue and 100 indicates the worst possible fatigue.
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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).
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General health measured with a visual analogue scale
기간: 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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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).
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- 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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- 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.
- Calin A, Nakache JP, Gueguen A, Zeidler H, Mielants H, Dougados M. Defining disease activity in ankylosing spondylitis: is a combination of variables (Bath Ankylosing Spondylitis Disease Activity Index) an appropriate instrument? Rheumatology (Oxford). 1999 Sep;38(9):878-82. doi: 10.1093/rheumatology/38.9.878.
- 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.
- Schoels M, Aletaha D, Funovits J, Kavanaugh A, Baker D, Smolen JS. Application of the DAREA/DAPSA score for assessment of disease activity in psoriatic arthritis. Ann Rheum Dis. 2010 Aug;69(8):1441-7. doi: 10.1136/ard.2009.122259. Epub 2010 Jun 4.
- Thyberg I, Dahlstrom O, Bjork M, Arvidsson P, Thyberg M. Potential of the HAQ score as clinical indicator suggesting comprehensive multidisciplinary assessments: the Swedish TIRA cohort 8 years after diagnosis of RA. Clin Rheumatol. 2012 May;31(5):775-83. doi: 10.1007/s10067-012-1937-0. Epub 2012 Jan 17.
- Schoels MM, Aletaha D, Alasti F, Smolen JS. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis. 2016 May;75(5):811-8. doi: 10.1136/annrheumdis-2015-207507. Epub 2015 Aug 12.
- Buchholz I, Thielker K, Feng YS, Kupatz P, Kohlmann T. Measuring changes in health over time using the EQ-5D 3L and 5L: a head-to-head comparison of measurement properties and sensitivity to change in a German inpatient rehabilitation sample. Qual Life Res. 2015 Apr;24(4):829-35. doi: 10.1007/s11136-014-0838-x. Epub 2014 Oct 30.
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- Bas Janssen MF, Birnie E, Bonsel GJ. Evaluating the discriminatory power of EQ-5D, HUI2 and HUI3 in a US general population survey using Shannon's indices. Qual Life Res. 2007 Jun;16(5):895-904. doi: 10.1007/s11136-006-9160-6. Epub 2007 Feb 10.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 11월 30일
기본 완료 (실제)
2026년 3월 5일
연구 완료 (실제)
2026년 3월 5일
연구 등록 날짜
최초 제출
2026년 4월 21일
QC 기준을 충족하는 최초 제출
2026년 5월 5일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 5일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Dnr 2022-04211-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
건선성 관절염에 대한 임상 시험
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Azienda Unita Sanitaria Locale di PiacenzaUniversity of Parma모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)체코, 이탈리아
EQ-5D-5L에 대한 임상 시험
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Vascutek Ltd.모집하지 않고 적극적으로대동맥 박리 | 대동맥류, 흉부 | 대동맥 파열 | 관통 대동맥 궤양 | 급성 대동맥 박리독일, 캐나다, 이탈리아, 네덜란드
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Centre Hospitalier Universitaire de Nice모병
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University Hospital, Toulouse모병허혈성 심장 질환 | 심실 빈맥프랑스
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University Hospital, ToulouseSanofi; Institut National de la Santé Et de la Recherche Médicale, France; Takeda모병
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KU LeuvenUniversitair Ziekenhuis Brussel; AZ Delta; General Hospital Groeninge; UZ Leuven, Leuven, Belgium 그리고 다른 협력자들모병직장암 | LARS - 낮은 전방 절제 증후군 | 적극적인 감시벨기에