| Name of the Instrument/Tool | Clinical Trials ESSDAI (ClinTrialsESSDAI) |
| First Description |
de Wolff L, Arends S, Pontarini E, Bombardieri M, Bowman SJ, Bootsma H. Development and performance of the Clinical Trials ESSDAI (ClinTrialsESSDAI), consisting of frequently active clinical domains, in two randomised controlled trials in primary Sjögren's syndrome. Clin Exp Rheumatol. 2021 Nov-Dec;39 Suppl 133(6):100-106. |
| Year | 2021 |
| Domains | |
| Concept of constructs | Disease activity |
| Population/Disease | Disease specific |
| Originally developed for | Sjögren's syndrome |
| Other rheumatic diseases where can be applied (only if validated) |
--- |
| Additional population with no rheumatic diseases |
No |
| Language: Originally published in | English |
| Available in Language | --- |
| REFERENCE IDENTIFICATION | |
| Author/s | de Wolff L, Arends S, Pontarini E, Bombardieri M, Bowman SJ, Bootsma H. |
| Title | Development and performance of the Clinical Trials ESSDAI (ClinTrialsESSDAI), consisting of frequently active clinical domains, in two randomised controlled trials in primary Sjögren’s syndrome. |
| Journal | Clin Exp Rheumatol |
| Year | 2021 |
| Vol | 39 |
| Num | 6 |
| Pages | 100-106 |
| Country | Netherlands |
| Language | English |
| Other references of interest | |
| No other References. | |
| Instrument/Tool Translations References | |
| No other References. | |
| DEVELOPER CONTACT INFORMATION | |
| Correspondence to | Hendrika Bootsma |
| h.bootsma@umcg.nl | |
| Address | Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, The Netherlands |
| Website | --- |
| Available | --- |
| Links | --- |
| DESCRIPTION OF THE INSTRUMENT | |
| Type Of Measure | Composite Index |
| Brief Description |
The ClinTrialsESSDAI was created using data from the Abatacept Sjögren Active Patients phase III (ASAP-III) RCT and the Trial of Anti-B cell Therapy in Patients with Primary Sjögren’s Syndrome (TRACTISS) RCT. Total score was calculated using existing weightings of the ClinESSDAI (which also excludes the biological domain). The six most frequently active clinical ESSDAI domains at baseline in the ASAP-III trial were: glandular (any activity: 91%), articular (58%), constitutional (46%), haematological (43%), lymphadenopathy (29%) and cutaneous (23%) domain. In the TRACTISS trial they were: articular (44%), haematological (24%), glandular (21%), constitutional (15%), cutaneous (11%) and lymphadenopathy (9%). These domains were selected to include in the ClinTrialsESSDAI |
| Number of Items | 6 |
| Range | 0-48 |
| Responses options/scale |
Yes High: scores being 0-3. |
| Developed for | --- |
| PRACTICAL APPLICATION | |
| Method of administration | Physician |
| Recommendations to score |
Each item is rated in 3 to 4 levels (No, Low, Moderate, High) scores being 0-3.
|
| Score Interpretation | The higher the score, the higher the activity |
| Cut-off points | --- |
| Cut-off points applied to | --- |
| Smallest detectable change if described | --- |
| Smallest detectable change applied to | --- |
| Completion time by the patient | - minutes |
| Scoring time by the assessor | - minutes |
| Training to score | Not necessary |
| Strengths | Useful in clinical practice & research |
| Limitations | --- |
| OTHER COMMENTS | |
| Other Comments | --- |