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RATIONAL is a multinational, multicentre, observational, cross sectional study of adult patients in treatment with NSAID therapy for OA, RA or AS during for at least 2 weeks before study visit (at least one dose).
Prevalence study of gastrointestinal risk factors in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving treatment with non- steroidal anti- inflammatory drugs.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subject with age above 60 years. | Up to 4 weeks. | |
| Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs. | Up to 4 weeks. | |
| Number of patients with previous ulcer history. | Up to 4 weeks. | |
| Number of patients with previous ulcer bleeding history. | Up to 4 weeks. | |
| Number of patients with history of dyspepsia. | Up to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status. | Up to 4 weeks. | |
| Descriptive profile of medical history: nicotine use, relevant medical conditions, history peptic ulcer, chronic drug therapy related to relevant medical conditions. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients over 21 years old, diagnosed with OA, RA or AS who are receiving at least one dose of NSAIDs for at least 2 weeks (15 days) before study visit, who attend to primary care centres, specialists offices, hospitals, private centres, urban or rural.
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo Citera, Rheumatologist | Universidad Nacional de Buenos Aires. Argentina | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Avellaneda | Argentina | Argentina | |||
| Research Site |
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| Up to 4 weeks. |
| Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI. | Up to 4 weeks. |
| Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis. | Up to 4 weeks. |
| Descriptive profile of Health Care Resources consumption: number of hospitalizations due to the rheumatic disorder and/or GI complications. | Up to 4 weeks. |
| Gastrointestinal Symptoms Rating Scale (GSRS). | Rating scale for gastrointestinal symptoms in patients, consisting of five areas: reflux syndrome, abdominal pain, constipation syndrome, diarrhoea syndrome and indigestion syndrome. | Up to 4 weeks. |
| Treatment Satisfaction for medication for OA patients (TSQM). | Assessment of patients' satisfaction with medication, providing scores on four scales: side effects, effectiveness, convenience and global satisfaction. | Up to 4 weeks. |
| Treatment adherence (Morisky Medication Assessment Scale- MMAs-4). | A generic self-reported, medication-taking behaviour scale in which the specific health issue (e.g. rheumatic pain and dyspepsia) is inserted for the "health concern". The MMAS-4 consists of four items with a scoring scheme of "Yes" = 0 and "No" = 1. The items are added together to give a range of scores from low adherence to high adherence (0 to 4). | Up to 4 weeks. |
| Patient Quality of Life (EQ-5D). | The questionnaire consists of 2 aspects: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems and severe problems. | Up to 4 weeks. |
| Osteoarthritis Index capturing elements of pain and physical disability (WOMAC VA3.1). | Osteoarthritis Index, self-administered, to report health status which is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function). | Up to 4 weeks. |
| Health Assessment Questionnaire (HAQ). | Comprehensive measure of outcome in patients with a wide variety of rheumatic diseases. | Up to 4 weeks. |
| Bahía Blanca |
| Argentina |
| Argentina |
| Research Site | Banfield | Argentina | Argentina |
| Research Site | Campana | Argentina | Argentina |
| Research Site | Capital Federal | Argentina | Argentina |
| Research Site | Corrientes | Argentina | Argentina |
| Research Site | La Plata | Argentina | Argentina |
| Research Site | Luján | Argentina | Argentina |
| Research Site | Mar del Plata | Argentina | Argentina |
| Research Site | Mendoza | Argentina | Argentina |
| Research Site | Olivos | Argentina | Argentina |
| Research Site | Paraná | Argentina | Argentina |
| Research Site | Rio Negro | Argentina | Argentina |
| Research Site | Rosario | Argentina | Argentina |
| Research Site | San Isidro | Argentina | Argentina |
| Research Site | San Justo | Argentina | Argentina |
| Research Site | San Luis | Argentina | Argentina |
| Research Site | San Miguel de Tucumán | Argentina | Argentina |
| Research Site | Santa Fe | Argentina | Argentina |
| Research Site | Sarandi - Avellaneda | Argentina | Argentina |
| Research Site | Venado Tuerto | Argentina | Argentina |
| Research Site | Vicente López | Argentina | Argentina |
| Research Site | Bogotá | Colombia | Colombia |
| Research Site | Bucaramanga | Colombia | Colombia |
| Research Site | Cali | Colombia | Colombia |
| Research Site | Kuala Selangor | Malaysia |
| Research Site | Putrajaya | Malaysia |
| Research Site | Mexico City | Mexico City | Mexico |
| Research Site | Aguascalientes | Mexico | Mexico |
| Research Site | Boca El Rio | Mexico | Mexico |
| Research Site | Cuernavaca | Mexico | Mexico |
| Research Site | Durango | Mexico | Mexico |
| Research Site | Guadalajara | Mexico | Mexico |
| Research Site | Monterrey | Mexico | Mexico |
| Research Site | Saltillo | Mexico | Mexico |
| Research Site | San Luis Potosi | Mexico | Mexico |
| Research Site | Tuxtla Gutierrez | Mexico | Mexico |
| Research Site | Zapopan | Mexico | Mexico |
| Research Site | Naucalpan | State of Mexico | Mexico |
| Research Site | Toluca | State of Mexico | Mexico |
| Research Site | Davao City | Philippines | Philippines |
| Research Site | Manila | Philippines | Philippines |
| Research Site | Barnaul | Russia | Russia |
| Research Site | Chelyabinsk | Russia | Russia |
| Research Site | Electrostal | Russia | Russia |
| Research Site | Irkutsk | Russia | Russia |
| Research Site | Kazan' | Russia | Russia |
| Research Site | Kemerovo | Russia | Russia |
| Research Site | Krasnodar | Russia | Russia |
| Research Site | Krasnoyarsk | Russia | Russia |
| Research Site | Moscow | Russia | Russia |
| Research Site | Nizhny Novgorod | Russia | Russia |
| Research Site | Novosibirsk | Russia | Russia |
| Research Site | Perm | Russia | Russia |
| Research Site | Saint Petersburg | Russia | Russia |
| Research Site | Samara | Russia | Russia |
| Research Site | Tyumen | Russia | Russia |
| Research Site | Ufa | Russia | Russia |
| Research Site | Volgograd | Russia | Russia |
| Research Site | Yaroslavl | Russia | Russia |
| Research Site | Yekaterinburg | Russia | Russia |
| Research Site | Bucheon-si | Republic of Korea | South Korea |
| Research Site | Busan | Republic of Korea | South Korea |
| Research Site | Cheongju-si | Republic of Korea | South Korea |
| Research Site | Daegu | Republic of Korea | South Korea |
| Research Site | Hwasun-gun | Republic of Korea | South Korea |
| Research Site | Incheon | Republic of Korea | South Korea |
| Research Site | Jeonju | Republic of Korea | South Korea |
| Research Site | Seoul | Republic of Korea | South Korea |
| Research Site | Suwon | Republic of Korea | South Korea |
| Research Site | Ulsan | Republic of Korea | South Korea |
| Research Site | Wŏnju | Republic of Korea | South Korea |
| Research Site | Hat Yai | Thailand | Thailand |
| Research Site | Klongluang | Thailand | Thailand |
| Research Site | Muang | Thailand | Thailand |
| Research Site | Prannok | Thailand | Thailand |
| Research Site | Barquisimeto | Venezuela | Venezuela |
| Research Site | Caracas | Venezuela | Venezuela |
| Research Site | Maracaibo | Venezuela | Venezuela |
| Research Site | Maturín | Venezuela | Venezuela |
| Research Site | Mérida | Venezuela | Venezuela |
| Research Site | Porlamar | Venezuela | Venezuela |
| Research Site | Punto Fijo | Venezuela | Venezuela |
| Research Site | Hanoi | Vietnam |
| Research Site | Ho Chi Minh City | Vietnam |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
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