Ultrasound Utility in Routine Clinical Practise

NCT ID: NCT03124225

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 258 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-06-30

Brief Summary

The aim of this research study is to describe the impact of rheumatologist performed ultrasound on the diagnosis and management pathways of patients with rheumatoid arthritis. Primarily, to compare the time from first visit to treatment initiation between patients with and without rheumatologist-performed ultrasound assessment.

Detailed Description

There are currently no guidelines for best practice in the use of ultrasound in RA and interim results from a survey by the British Society of Rheumatology (BSR) in this area have suggested that practice is variable across the UK. NICE recognize that the earlier persistent synovitis is identified and treated with disease modifying anti-rheumatic drugs DMARDs, the better the long term outcome and have welcomed the need to determine the role of imaging in assisting with this early diagnosis, and whether the added cost is justified by better disease outcomes.

This is a multi-site prospective observational study which investigates the use of ultrasound imaging in the context of patients with early arthritis presenting to secondary care. The time to commencement of DMARD therapy and diagnosis of Rheumatoid arthritis are therein outcome measures. Patients are followed up for 12 months after their first presentation and time to diagnosis or DMARD commencement recorded.

Conditions

Arthritis, Rheumatoid; Ultrasonography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ultrasound

Early Arthritis Patients seeing a Rheumatologist who uses US for assessment routinely in clinic

DMARD

Intervention Type: DRUG

Non-Ultrasound

Early Arthritis Patients seeing a Rheumatologist who does not uses US for assessment routinely in clinic

DMARD

Intervention Type: DRUG

Interventions

DMARD

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥18 years at the time of presentation to the clinic Patients newly presenting to the rheumatology clinic with suspected inflammatory arthritis

Exclusion Criteria

• For the non-ultrasound arm; patients who have been referred to another rheumatologist or radiologist for ultrasound Patients who decline or who are unable to consent to the use of their medical records for research

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IMM 09-0270

Identifier Type: -

Identifier Source: org_study_id