Comparison of ESSDAI and ClinESSDAI in potential optimisation of trial outcomes in primary Sjögren's syndrome: examination of data from the UK Primary Sjögren's Syndrome Registry.
- Dumusc A University Hospital Lausanne, Switzerland / University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.
- Ng WF Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom / Musculoskeletal Research Group, Institute of Cellular Medicine and Newcastle NIHR Biomedical Research Centre for Ageing and Chronic Diseases, Newcastle University, N.
- James K Interdisciplinary Computing and Complex BioSystems research group, School of Computing Science, Newcastle University, Newcastle upon Tyne, United Kingdom.
- Griffiths B Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.
- Price E Great Western Hospitals NHS Foundation Trust, Swindon, United Kingdom.
- Pease C Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, United Kingdom.
- Emery P Nottingham University Hospital, Nottingham, United Kingdom.
- Lanyon P Nottingham University Hospital, Nottingham, United Kingdom.
- Jones A Nottingham University Hospital, Nottingham, United Kingdom.
- Bombardieri M Barts Health NHS Trust and Barts and the London School of Medicine and Dentistry, United Kingdom.
- Sutcliffe N Barts Health NHS Trust and Barts and the London School of Medicine and Dentistry, United Kingdom.
- Pitzalis C Barts Health NHS Trust and Barts and the London School of Medicine and Dentistry, United Kingdom.
- Gupta M Gartnavel General Hospital, Glasgow, United Kingdom.
- McLaren J NHS Fife, Whyteman's Brae Hospital, Kirkcaldy, United Kingdom.
- Cooper A Royal Hampshire County Hospital, Winchester, United Kingdom.
- Giles I University College London Hospitals NHS Foundation Trust, London, United Kingdom.
- Isenberg D University College London Hospitals NHS Foundation Trust, London, United Kingdom.
- Saravanan V Queen Elizabeth Hospital, Gateshead, United Kingdom.
- Coady D Sunderland Royal Hospital, Sunderland, UK.
- Dasgupta B Southend University Hospital, Southend, UK.
- McHugh N Royal National Hospital for Rheumatic Diseases, Bath, UK.
- Young-Min S Portsmouth Hospitals NHS Trust, Portsmouth, UK.
- Moots R Aintree University Hospitals, Liverpool, UK.
- Gendi N Basildon Hospital, Basildon, UK.
- Akil M Royal Hallamshire Hospital, Sheffield, UK.
- Barone F University of Birmingham, Birmingham, UK.
- Fisher B University of Birmingham, Birmingham, UK.
- Rauz S University of Birmingham, Birmingham, UK.
- Richards A Birmingham Dental Hospital, Birmingham, UK.
- Bowman S , UNITED KINGDOM.
- 2018-02-15
Published in:
- Swiss medical weekly. - 2018
Clinical Trials as Topic
Cohort Studies
Humans
Outcome Assessment, Health Care
Registries
Severity of Illness Index
Sjogren's Syndrome
United Kingdom
English
OBJECTIVES
To assess the use of the Clinical EULAR Sjögren's Syndrome Disease Activity Index (ClinESSDAI), a version of the ESSDAI without the biological domain, for assessing potential eligibility and outcomes for clinical trials in patients with primary Sjögren's syndrome (pSS), according to the new ACR-EULAR classification criteria, from the UK Primary Sjögren's Syndrome Registry (UKPSSR).
METHODS
A total of 665 patients from the UKPSSR cohort were analysed at their time of inclusion in the registry. ESSDAI and ClinESSDAI were calculated for each patient.
RESULTS
For different disease activity index cut-off values, more potentially eligible participants were found when ClinESSDAI was used than with ESSDAI. The distribution of patients according to defined disease activity levels did not differ statistically (chi2 p = 0.57) between ESSDAI and ClinESSDAI for moderate disease activity (score ≥5 and <14; ESSDAI 36.4%; ClinESSDA 36.5%) or high disease activity (score ≥14; ESSDAI 5.4%; ClinESSDAI 6.8%). We did not find significant differences between the indexes in terms of activity levels for individual domains, with the exception of the articular domain. We found a good level of agreement between both indexes, and a positive correlation between lymphadenopathy and glandular domains with the use of either index and with different cut-off values. With the use of ClinESSDAI, the minimal clinically important improvement value was more often achievable with a one grade improvement of a single domain than with ESSDAI. We observed similar results when using the new ACR-EULAR classification criteria or the previously used American-European Consensus Group (AECG) classification criteria for pSS.
CONCLUSIONS
In the UKPSSR population, the use of ClinESSDAI instead of ESSDAI did not lead to significant changes in score distribution, potential eligibility or outcome measurement in trials, or in routine care when immunological tests are not available. These results need to be confirmed in other cohorts and with longitudinal data.
To assess the use of the Clinical EULAR Sjögren's Syndrome Disease Activity Index (ClinESSDAI), a version of the ESSDAI without the biological domain, for assessing potential eligibility and outcomes for clinical trials in patients with primary Sjögren's syndrome (pSS), according to the new ACR-EULAR classification criteria, from the UK Primary Sjögren's Syndrome Registry (UKPSSR).
METHODS
A total of 665 patients from the UKPSSR cohort were analysed at their time of inclusion in the registry. ESSDAI and ClinESSDAI were calculated for each patient.
RESULTS
For different disease activity index cut-off values, more potentially eligible participants were found when ClinESSDAI was used than with ESSDAI. The distribution of patients according to defined disease activity levels did not differ statistically (chi2 p = 0.57) between ESSDAI and ClinESSDAI for moderate disease activity (score ≥5 and <14; ESSDAI 36.4%; ClinESSDA 36.5%) or high disease activity (score ≥14; ESSDAI 5.4%; ClinESSDAI 6.8%). We did not find significant differences between the indexes in terms of activity levels for individual domains, with the exception of the articular domain. We found a good level of agreement between both indexes, and a positive correlation between lymphadenopathy and glandular domains with the use of either index and with different cut-off values. With the use of ClinESSDAI, the minimal clinically important improvement value was more often achievable with a one grade improvement of a single domain than with ESSDAI. We observed similar results when using the new ACR-EULAR classification criteria or the previously used American-European Consensus Group (AECG) classification criteria for pSS.
CONCLUSIONS
In the UKPSSR population, the use of ClinESSDAI instead of ESSDAI did not lead to significant changes in score distribution, potential eligibility or outcome measurement in trials, or in routine care when immunological tests are not available. These results need to be confirmed in other cohorts and with longitudinal data.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.4414/smw.2018.14588
- PMID 29442344
- Persistent URL
- https://sonar.ch/global/documents/569
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