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.
Study Type
OBSERVATIONAL
Enrollment
5,383
Number of subject with age above 60 years.
Time frame: Up to 4 weeks.
Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs.
Time frame: Up to 4 weeks.
Number of patients with previous ulcer history.
Time frame: Up to 4 weeks.
Number of patients with previous ulcer bleeding history.
Time frame: Up to 4 weeks.
Number of patients with history of dyspepsia.
Time frame: Up to 4 weeks.
Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status.
Time frame: 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.
Time frame: Up to 4 weeks.
Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI.
Time frame: Up to 4 weeks.
Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis.
Time frame: Up to 4 weeks.
Descriptive profile of Health Care Resources consumption: number of hospitalizations due to the rheumatic disorder and/or GI complications.
Time frame: Up to 4 weeks.
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Research Site
Avellaneda, Argentina, Argentina
Research Site
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
...and 75 more locations
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Up to 4 weeks.
Health Assessment Questionnaire (HAQ).
Comprehensive measure of outcome in patients with a wide variety of rheumatic diseases.
Time frame: Up to 4 weeks.