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Tavares R.,UNCOVER Clinical Research Company | Huang S.,Sunnybrook Health science Center | Bykerk V.P.,Hospital for Special Surgery | Bykerk V.P.,Mt Sinai Hospital | Bell M.J.,Sunnybrook Health science Center
Rheumatology (United Kingdom) | Year: 2013

Objectives. To determine the comprehensibility, internal consistency, test-retest reliability and discriminative properties of an early inflammatory arthritis (IA) detection tool. Methods. Four groups were recruited from outpatient clinics at two tertiary care hospitals: early IA, established IA, non-IA musculoskeletal conditions (MSK) and non-MSK. Participants attended a study visit where they completed the 11-item tool with binary yes/no response options. Comprehensibility was assessed for each tool item on a 5-point Likert scale. For test-retest assessment, the tool was mailed to participants following a 2-week recall washout interval. Two items were randomly selected to test internal consistency. Discriminative properties compared tool item responses with blinded rheumatologist clinical assessments. A previously developed rheumatology triage algorithm was externally validated. Results. A total of 170 participants were enrolled in the study. Comprehensibility approached unity for all tool items. The internal consistency Kuder-Richardson Formula 20 was 0.985 (P<0.0001). The mean test-retest reliability kappa (S.D.) was 0.81 (0.02). The intraclass correlation coefficient (ICC) (95% CI) for summed yes responses between test and retest phases was 0.94 (0.93, 0.95) and for algorithm scores was 0.97 (0.96, 0.98). Patient responses were significantly associated with the corresponding clinical evaluations (P<0.0001, respectively). The sum of yes responses and rheumatology triage algorithm scores both differentiated early IA from each of the other three groups (P<0.004, respectively). The scoring algorithm receiver operating characteristic plot area under the curve (S.E.) was 0.829 (0.003). Conclusion. The tool has favourable measurement and discriminative properties. The discriminative properties of the rheumatology triage scoring algorithm were externally validated. © The Author 2013. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved.


Permanent joint damage is a major consequence of rheumatoid arthritis (RA), the most common and destructive form of inflammatory arthritis. In aggressive disease, joint damage can occur within 6 months from symptom onset. Early, intensive treatment with conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) can delay the onset and progression of joint damage. The primary objective of the study is to investigate the value of magnetic resonance imaging (MRI) or radiography (X-ray) over standard of care as tools to guide DMARD treatment decision-making by rheumatologists for the care of RA.Methods: A double-blind, randomized controlled trial has been designed. Rheumatoid and undifferentiated inflammatory arthritis patients will undergo an MRI and X-ray assessment every 6 months. Baseline adaptive randomization will be used to allocate participants to MRI, X-ray, or sham-intervention groups on a background of standard of care. Prognostic markers, treating physician, and baseline DMARD therapy will be used as intervention allocation parameters. The outcome measures in rheumatology RA MRI score and the van der Heijde-modified Sharp score will be used to evaluate the MRI and X-ray images, respectively. Radiologists will score anonymized images for all patients regardless of intervention allocation. Disease progression will be determined based on the study-specific, inter-rater smallest detectable difference. Allocation-dependent, intervention-concealed reports of positive or negative disease progression will be reported to the treating rheumatologist. Negative reports will be delivered for the sham-intervention group. Study-based radiology clinical reports will be provided to the treating rheumatologists for extra-study X-ray requisitions to limit patient radiation exposure as part of diagnostic imaging standard of care. DMARD treatment dose escalation and therapy changes will be measured to evaluate the primary objective. A sample size of 186 (62 per group) patients will be required to determine a 36% difference in pharmacological treatment escalation between the three groups with intermediate dispersion of data with 90% power at a 5% level of significance.Discussion: This study will determine if monitoring RA and undifferentiated inflammatory arthritis patients using MRI and X-ray every 6 months over 2 years provides incremental evidence over standard of care to influence pharmacotherapeutic decision-making and ultimately hinder disease progression.Trial registration: This trial has been registered at ClinicalTrials.gov: NCT00808496 (registered on 12 December 2008). © 2014 Tavares et al.; licensee BioMed Central Ltd.


Permanent joint damage is a major consequence of rheumatoid arthritis (RA), the most common and destructive form of inflammatory arthritis. In aggressive disease, joint damage can occur within 6months from symptom onset. Early, intensive treatment with conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) can delay the onset and progression of joint damage. The primary objective of the study is to investigate the value of magnetic resonance imaging (MRI) or radiography (X-ray) over standard of care as tools to guide DMARD treatment decision-making by rheumatologists for the care of RA.A double-blind, randomized controlled trial has been designed. Rheumatoid and undifferentiated inflammatory arthritis patients will undergo an MRI and X-ray assessment every 6months. Baseline adaptive randomization will be used to allocate participants to MRI, X-ray, or sham-intervention groups on a background of standard of care. Prognostic markers, treating physician, and baseline DMARD therapy will be used as intervention allocation parameters. The outcome measures in rheumatology RA MRI score and the van der Heijde-modified Sharp score will be used to evaluate the MRI and X-ray images, respectively. Radiologists will score anonymized images for all patients regardless of intervention allocation. Disease progression will be determined based on the study-specific, inter-rater smallest detectable difference. Allocation-dependent, intervention-concealed reports of positive or negative disease progression will be reported to the treating rheumatologist. Negative reports will be delivered for the sham-intervention group. Study-based radiology clinical reports will be provided to the treating rheumatologists for extra-study X-ray requisitions to limit patient radiation exposure as part of diagnostic imaging standard of care. DMARD treatment dose escalation and therapy changes will be measured to evaluate the primary objective. A sample size of 186 (62 per group) patients will be required to determine a 36% difference in pharmacological treatment escalation between the three groups with intermediate dispersion of data with 90% power at a 5% level of significance.This study will determine if monitoring RA and undifferentiated inflammatory arthritis patients using MRI and X-ray every 6months over 2years provides incremental evidence over standard of care to influence pharmacotherapeutic decision-making and ultimately hinder disease progression.This trial has been registered at ClinicalTrials.gov: NCT00808496 (registered on 12 December 2008).

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