The framework included the following 5 major outcomes:
Mortality
Health status
Symptoms (pain, stiffness, fatigue, sleep disturbance, swelling)
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Measures include the Bath AS Disease Activity Index, pain scales, Short Form 36 subscales, and fatigue questionnaires
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Surrogates include physical examination, AS Disease Activity Score, acute-phase reactants, and inflammation on imaging
Mental health (depression, anxiety) Measures include the Short Form 36 subscales
Quality of life (social interaction, sexual health, body image) Measures include the Short Form 36 subscales and AS Quality of Life questionnaire
Functional status
Physical function
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Measures include the Bath AS Functional Index and Short Form 36 subscales
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Surrogates include range of motion, the Bath AS Metrology Index, and structural damage on imaging
Work ability
Serious adverse events
AS-related morbidities
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