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FRI0601 A Dual-Center, Double Blind Randomized Study for a New Scientific Approach in Assessment of Tender Joints in Inflammatory Arthritis Using the Smart Joint Assessor Glove Device (Smart JAG Device)
  1. M.F. Khan1,2
  1. 1Research, University of Oklahoma Health Sciences Center
  2. 2Research, Arthritis and Rheumatology Center of Oklahoma, Oklahoma City, United States

Abstract

Background Tender Joint Count (TJC) is a vital quality measure to assess the progression of Inflammatory Arthritis both from a therapeutic and a diagnostic standpoint. To date no scientific instruments are available to validate and standardize a Joint Count and these assessments remain largely subjective to the Joint Assessor. Physician variability, depending upon the technique and the force used in Tender joint count assessments, can significantly impact the Disease Activity Scores. Both inter and intra-observer variability bias in assessing Tender Joint Count can be pivotal in impacting the outcome of a trial.

Objectives Primary Objective: Tender Joint Count Assessments are significantly more accurate using the Smart JAG Device than with conventional Joint Assessments.

Secondary Objective: Establishing a high degree of consistency over time to monitor therapeutic response and improved joint function.

Methods We present a smart hand held glove device for Tender Joint Count Assessment. The first of its kind that allows standardizing a joint exam based on scientific rationale.

We examined 100 patients (2800 joints) with moderate to severe inflammatory arthritis as defined by ACR criteria for their respective disease states maintained on DMARD therapy. A standardized 28 Joint Count was performed on all subjects. Each subject underwent a Tender Joint Exam by a total of 4 different assessors that were blindly randomized to the device. Two Joint Assessors performed the joint count using the device and two performed without the device. All joint assessors were blinded. Each joint count was performed after approximately 30 minute intervals. All assessors were blindly randomized to the device. The device was programmed at 4kg pressure to beep as a signal so that the same amount of pressure was applied consistently throughout on all the joints measured. The device beeped every time on reaching the desired pressure. This smart device has the capability of connecting via wireless connection to computer software with a built-in voice recognition system. Tender Joints are captured based on voice recognition of the Assessor in real time. The software has LED mode feature for the hearing impaired. At the conclusion of the Joint Assessment, this software is able to give a total Tender Joint Count with memory capability that can be retrieved. It can also calculate a CDAI and DAS-28 if needed.

Results There was striking difference in consistencies between the 2 groups. We found only 4.5% discrepancy within the device users as compared to 15% in non-device users. We performed a “paired t-test” between the discrepancy measures from the 2 groups. We found strong statistical significance between the 2 groups. (p<9.8×10-8).There were no significant differences in the overall mean tender joints in either group.

Conclusions The device measures tender joints with high accuracy and has less discrepancy between different users. Can be used by other health care personnel as joint assessors and has a high yield to assess therapeutic efficacy over time. It is also much less time consuming and standardizes tender joint exams by keeping the pressure as constant with less inter and intra observer variability.

Disclosure of Interest None declared

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