Article Figures & Data
Figures
- Figure 1.
Outcomes and outcome measures used in studies of Behçet syndrome: systematic literature search strategy and results.
Tables
- Table 1.
Overall disease assessment outcomes and outcome measures used in studies of Behçet syndrome. Numerals in parentheses indicate references.
RCT*, n = 25 Other**, n = 150 Biomarker, n = 73 Overall, n = 248 Behçet’s Disease Current Activity Form (BDCAF) (7–30) — 17 7 24 Clinical Disease Activity Index (32) — 1 — 1 Clinical Manifestations Index (33,34,35) 1 2 — 3 Iranian BD Dynamic Activity Measure (18,20,31,37) 1 3 — 4 1994 Criteria for Disease Activity of BD (36) — 1 — 1 Activity, self-defined (38–87) — 4 46 50 Activity, not defined (88–91) — 4 4 Krause’s total severity score (38,46,51,57,104–114) — 11 4 15 Severity (self-defined) (12,32,60,65,82,115–117) 1 2 6 9 Relapse (30,119–121) — 2 1 3 Response (complete/partial) (30,122,123) — 3 3 Remission (complete/partial) (71,72,90,119–121) 1 1 4 6 Physicians Global Assessment (18,211) — 2 — 2 BD Quality of Life (19,124,125) — 3 — 3 Proportion of patients remaining on treatment (30) — 1 — 1 Development of major organ involvement (98,122,174) 1 2 — 3 Death (92–103) — 11 — 11 -
↵* Only 4 of the 25 RCT used an outcome measure for overall disease assessment.
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↵** The outcome measures used in uncontrolled interventional studies, cohorts, and case control studies are given together under the “other studies” column. A total of 66 outcome measures for overall disease assessment were used in these 150 studies. Similarly, biomarker studies and generic association studies are given together under the “Biomarker” column. RCT: randomized controlled trial; BD: Behçet disease.
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- Table 2.
Organ specific outcomes and outcome measures used in studies of Behçet syndrome for mucocutaneous, musculoskeletal, eye, vascular, neurologic, and gastrointestinal involvement. Numerals in parentheses indicate references.
RCT Other* Biomarker Overall Mucocutaneous disease (n) 18 14 0 32 Frequency of oral ulcers/genital ulcers/nodular lesions/papulopustular lesions (57,120,131,135,138,139,243,245) 6 2 — 8 Number of oral ulcers/genital ulcers/nodular lesions/papulopustular lesions (127,128,130,132–135,137,139,140,185,244,246–248) 10 5 — 15 Duration of oral ulcers/genital ulcers/nodular lesions/papulopustular lesions (118,120,135,138) 3 1 — 4 Size of oral ulcers/genital ulcers (129,130,135,244,249) 3 2 — 5 Pain of oral ulcers/genital ulcers (120,129–131,134,243) 4 2 — 6 Severity of oral ulcers/genital ulcers (118,246) 1 1 — 2 Healing time of oral ulcers/genital ulcers (57,128–131,243,249) 2 5 — 7 Depth of oral ulcers/genital ulcers (244) 1 — 1 Pathergy positivity (35,133,244) 1 2 — 3 Oral Ulcer Activity Index (126) 1 — 1 Response (complete/partial) (30,118,136,137,250) 3 2 — 5 Remission (complete/partial) (251) — 1 — 1 Musculoskeletal disease (n) 6 1 _ 7 No. arthritis episodes (132,133,137,139,142) 5 — 5 Frequency of arthritis episodes (139,141) 1 1 — 2 Severity of arthritis episodes (142) 1 — — 1 Duration of arthritis episodes (139,142,143) 3 — — 3 Tender joint score (143) 1 — — 1 Degree of joint swelling (143) 1 — — 1 Arthritis pain visual analog scale (143) 1 — — 1 Vascular (n) — 14 — 14 Venous thrombosis relapse (92,95,197) — 3 — 3 New/recurrent aneurysm (96,100,198,199,201,203) — 6 — 6 Disappearance of intracardiac thrombus (202) — 1 — 1 Remission (93,94) — 2 — 2 Death (92–96,100,102,199) — 8 — 8 Amputation (96) — 1 — 1 Operation need (95) — 1 — 1 Postoperative complications (96,100,199,200,203) — 5 — 5 Graft occlusion/patency (96,100,199,200,201,203) — 6 — 6 Neurologic (n) — 7 — 8 Functional outcome (independent/dependent/death) (206,210) — 2 — 2 Improvement (97,204) — 2 — 2 Poor outcome (97) — 1 — 1 Death (97) — 1 — 1 Relapse (204,205) — 2 — 2 Progressive course (205) — 1 — 1 Expanded Disability Status Scale (205,208,209) — 3 — 3 Neuropathic pain (207) — 1 — 1 Multiple sclerosis functional compound scale (208) — 1 — 1 Eye involvement (n) 7 53 3 63 Ocular inflammatory attack (9,15,120,144,147,155–158, 161,162,164–166,169–171,173,176,181,183,184,186,188–196) 6 25 1 32 Visual acuity (9,15,16,120,144–190) 7 43 1 51 Loss of useful vision/blindness (99,160,163,167,174–177) — 8 — 8 Improvement of uveoretinitis (145) — 1 — 1 Retinal vasculitis (149,166,181,185) 2 1 1 4 Hypopyon (149,166,181,185) 2 1 1 4 Ben Ezra Disease Activity Index (15,25,152,153) 1 3 — 4 Total Inflammatory Activity Index (152,153) — 2 — 2 Total Adjusted Disease Act Index (152,153) — 2 — 2 Worsening of intraocular inflammation (190) 1 — 1 Regression of inflammatory signs (252) — 1 — 1 Improvement in fundus fluorescein angiography findings (168) 1 — — 1 Macular thickness (146,181) 1 1 — 2 Remission (16,155,157,163,165,169,186,193) — 7 1 8 Response (complete/partial) (155,161) — 2 — 2 Time to remission (191) — 1 — 1 Time to relapse/recurrence (15,191,194) — 3 — 3 National Eye Institute Visual Functioning Questionnaire (151) — 1 — 1 Number of relapse-free patients (147) — 1 — 1 Inflammation score — self-defined (159) — 1 — 1 Duration of ocular attacks (171,188) — 2 — 2 Vascular sheathing (181) — 1 — 1 Venous occlusion (181) — 1 — 1 Vitreous condensation (181) — 1 — 1 SUN visual loss (16) — 1 — 1 SUN lowering glucocorticoid dose to < 10 mg/day (253) — 1 — 1 SUN control of uveitis with quiescence during maintenance (150) — 1 — 1 SUN ocular relapse per patient year (150) — 1 — 1 SUN intraocular inflammation (146,154,176) — 3 — 3 SUN level of steroid dependence (154) — 1 — 1 SUN complete/partial/no response (154) — 1 — 1 SUN improvement/worsening (15,176) — 2 — 2 Hogan’s ocular inflammatory attack criteria for anterior uveitis (180,188,254) — 3 — 3 Kimura’s ocular inflammatory attack criteria for posterior uveitis (180,188) — 2 — 2 Development of new eye disease (174,185) 1 1 — 2 Gastrointestinal (n) — 14 3 17 Disease Activity Index for Intestinal BD (211,216,218,220,221) — 4 1 5 Inflammatory Bowel Disease Questionnaire (224) — 1 — 1 Crohn’s Disease Activity Index (211,224,227) — 3 — 3 Harvey Bradshaw Index for Activity (224,227) — 2 — 2 St. Mark’s Activity Index (224) — 1 — 1 Relapse/recurrence (212–215,217,219,222,223,225,226) — 9 1 10 Remission (212–214,223) — 3 1 4 Operation need (211,212,214,217,221,223) — 5 1 6 Reoperation need (213,217,219,222,225,226) — 6 6 Physician’s global assessment (211) — 1 1 Immunosuppressive need (217,221) — 2 2 Glucocorticoid requirement (217,221) — 2 2 -
↵* The outcome measures used in uncontrolled interventional studies, cohorts, and case control studies are given together under the “Other Studies” column. Similarly, biomarker studies and genetic association studies are given together under the “Biomarker” column. RCT: randomized controlled trial; BD: Behçet disease; SUN: Standardization of Uveitis Nomenclature.
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- Table 3.
Nondisease–specific outcome measures used in studies of Behçet syndrome. Numerals in parentheses indicate references.
RCT, n = 0 Other, n = 36 Biomarker, n = 0 Overall, n = 36 SF-36 (46,57,151,239) — 4 — 4 Health-related QOL (224,239) — 2 — 2 WHO QOL 100 (46) — 1 — 1 WHO QOL BREF (240) — 1 — 1 EQ-5D (229) — 1 — 1 Dermatology Life Quality Index (12,255) — 2 — 2 Oral Health Related Quality of Life (57) — 1 — 1 Oral Health Impact Profile (57,128,131,234) — 4 — 4 Nottingham Health Profile (23,141) — 2 — 2 Life Satisfaction Index (23) — 1 — 1 Lawton Instrumental Activities of Daily Living (125) — 1 — 1 Kate Index of Activities of Daily Living (125) — 1 — 1 Health Assessment Questionnaire (HAQ) (124,141) — 2 — 2 Multidimensional HAQ (MDHAQ) (237,256) — 2 — 2 Brief Symptom Inventory (230) — 1 — 1 Beck Depression Scale (17,60,141,208,230,232,235,236,238,239,240) — 11 — 11 Beck Anxiety Scale (230,238,239,241) — 4 — 4 Beck Hopelessness Scale (238) — 1 — 1 Hamilton Depression Rating Scale (12,228,241) — 3 — 3 Hamilton Anxiety Rating Scale (12,228) — 2 — 2 Center for Epidemiologic Studies Depression Scale (19) — 1 — 1 Psychological General Wellbeing Scale (124,207) — 2 — 2 Automatic Thoughts Questionnaire (238) — 1 — 1 Hospital Depression Scale (231) — 1 — 1 Hospital Anxiety Scale (231) — 1 — 1 State Trait Anxiety Inventory (60,141) — 2 — 2 Toronto Alexithymia Scale (241) — 1 — 1 Epworth Sleepiness Scale (12) — 1 — 1 Respiratory Disturbance Index (12) — 1 — 1 Apneahypopnea Index (12) — 1 — 1 Pittsburgh Sleep Quality Index (12,207) — 2 — 2 Female Sexual Function Index (236) — 1 — 1 International Index of Erectile Function (235) — 1 — 1 Arizona Sexual Experience Scale (228) — 1 — 1 Golombok Rust Sexual Satisfaction Scale (228) — 1 — 1 Voice Handicap Test (233) — 1 — 1 Fibromyalgia Impact Questionnaire (10,60) — 2 — 2 Fatigue Severity Scale (12) — 1 — 1 -
SF-36: Medical Outcomes Study Short Form-36; WHO: World Health Organization; QOL: quality of life.
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