Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the health related quality of life of patients with systemic sclerosis with other rheumatic diseases, such as rheumatoid arthritis, systemic lupus erythematosus and Sjogren's syndrome.
Systemic sclerosis (SSc) is a connective tissue disease characterized by vasculopathy, fibrosis, and autoimmunity. The prognosis of the disease depends on the nature and severity of organ involvement. Patients with SSc suffer from digital ulceration, arthritis, progressive skin tightening, and joint contractures that cause pain and limitation of limb function. The cardiopulmonary system may also be severly affected by SSc in the form of interstitial lung disease and pulmonary arterial hypertension, which leads to reduction in exercise capacity and symptomatic dyspnea. Gastrointestinal involvement by SSc may cause malnutrition, and SSc renal crises may result in renal failure. In addition, cosmetic disfigurement resulting from facial and limb skin involvement may lead to social isolation, mood problems, and significant work disability.
It has been reported that health related quality of life (HRQoL) is significantly impared in SSc patients compared to the general population. Moreover, the degree of impairment in SSc patients was comparable to those who suffered from other chronic illnesses such as heart and lung disease, hypertension, diabetes mellitus, and depression. However, there were no studies yet comparing the HRQoL of SSc patients with other rheumatic diseases, such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Especially, information regarding the impact of SSc on functioning and HRQoL in Korean patients is lacking.
Therefore, the investigators plan to compare the functioning and HRQoL of patients with SSc with other rheumatic diseases, such as RA, SLE, and Sjogrens's syndrome, and healthy controls. A validated Korean version of the Medical Outcomes Study Short Form 36 (SF36) questionnaire and the EuroQol five dimensions questionnaire (EQ-5D) will be used in this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic sclerosis (SSc) | validated Korean version of the SF36 and EQ-5D |
| |
| Rheumatoid arthritis (RA) | validated Korean version of the SF36 and EQ-5D |
| |
| Systemic lupus erythematosus (SLE) | validated Korean version of the SF36 and EQ-5D |
| |
| Sjogren's syndrome | validated Korean version of the SF36 and EQ-5D |
| |
| Control | validated Korean version of the SF36 and EQ-5D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| validated Korean version of the SF36 and EQ-5D | Other | This is an observational prospective study. SF36 consists of 36 questions that measure patient's HRQoL in 8 domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) that represent the physical HRQoL, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH) that represent the mental HRQoL. Each domain is scored from 0 (worst health status) to 100 (best health status). The scores of these domains are summarized into the physical component score (PCS) and mental component score (MCS). The EQ-5D questionnaire is made up for 2 components; health state description and evaluation. In description part, health status is measured in terms of 5 dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS). |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of physical component scores (PCS) of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases | once at inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of mental component scores (MCS) of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases | once at inclusion | |
| comparison of physical functioning (PF) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients treated at the Rheumatology clinic at Seoul National University Hospital from March 2017 through to December 2017
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Bong Lee, MD, PhD | Contact | +822-2072-3944 | leb7616@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Eun Bong Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19228662 | Background | Hudson M, Thombs BD, Steele R, Panopalis P, Newton E, Baron M; Canadian Scleroderma Research Group. Quality of life in patients with systemic sclerosis compared to the general population and patients with other chronic conditions. J Rheumatol. 2009 Apr;36(4):768-72. doi: 10.3899/jrheum.080281. Epub 2009 Feb 17. | |
| 16754629 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| once at inclusion |
| comparison of physical role (PR) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases | once at inclusion |
| comparison of bodily pain (BP) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases | once at inclusion |
| comparison of general health (GH) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases | once at inclusion |
| comparison of vitality (VT) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases | once at inclusion |
| comparison of social functioning (SF) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases | once at inclusion |
| comparison of emotional role (ER) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases | once at inclusion |
| comparison of mental health (MH) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases | once at inclusion |
| comparison of the scores of the EQ-5D questionnaire between patients with systemic sclerosis and other rheumatic diseases | once at inclusion |
| Georges C, Chassany O, Toledano C, Mouthon L, Tiev K, Meyer O, Ilie D, Rambeloarisoa J, Marjanovic Z, Cabane J, Sereni D, Pouchot J, Farge D. Impact of pain in health related quality of life of patients with systemic sclerosis. Rheumatology (Oxford). 2006 Oct;45(10):1298-302. doi: 10.1093/rheumatology/kel189. Epub 2006 Jun 4. |
| 15188336 | Background | Del Rosso A, Boldrini M, D'Agostino D, Placidi GP, Scarpato A, Pignone A, Generini S, Konttinen Y, Zoppi M, Vlak T, Placidi G, Matucci-Cerinic M. Health-related quality of life in systemic sclerosis as measured by the Short Form 36: relationship with clinical and biologic markers. Arthritis Rheum. 2004 Jun 15;51(3):475-81. doi: 10.1002/art.20389. |
| 30770765 | Derived | Park EH, Strand V, Oh YJ, Song YW, Lee EB. Health-related quality of life in systemic sclerosis compared with other rheumatic diseases: a cross-sectional study. Arthritis Res Ther. 2019 Feb 15;21(1):61. doi: 10.1186/s13075-019-1842-x. |