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Abstract Number: 288

Establishing Clinical Meaning and Defining Important Differences in Patient Reported Outcome Measures of Physical Function, Fatigue and Pain Interference in Juvenile Idiopathic Arthritis

Esi M. Morgan DeWitt1, Bin Huang2,3, Kimberly Barnett4, Adam Carle5, Constance Mara6 and Karon Cook7, 1Department of Pediatrics, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 2Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center/University of Cincinnati School of Medicine, Cincinnati, OH, 3Pediatrics, University of Cincinnati School of Medicine, Cincinnati, OH, 4Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 5Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 6James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 7Center for Patient-Centered Outcomes - Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Fatigue, juvenile idiopathic arthritis (JIA), pain, patient-reported outcome measures and physical function

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Session Information

Session Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects: Juvenile Idiopathic Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose

Patient reported outcome measures (PROs) are used increasingly in clinical care. A framework to interpret scores according to degree of clinical severity would enhance their practical use. Furthermore, use of PROs in evaluation of treatment effectiveness over time requires establishment of minimal important differences (MID) in change scores. 

Methods

We identified clinical severity thresholds and MID for measures of mobility, upper extremity function, fatigue, and pain interference working with patients with juvenile idiopathic arthritis (JIA) and parents of JIA patients using standard setting methodology modified from educational testing. Data from Patient-Reported Outcomes Measurement Information System (PROMIS) item bank longitudinal validation collected on 121 JIA patients was used to develop clinical vignettes across a range of symptom severity. Vignettes were created based on most likely item responses at different levels on the T score metric [mean = 50; SD = 10]. Vignettes were anchored at 5-point intervals (0.5 SDs). Parents and patients participated in separate one-day meetings. Vignettes were ordered and placed on cards. Panelists identified adjacent vignettes considered to represent upper and lower boundaries separating category cut points (i.e., none /mild problems, mild/moderate, moderate/severe). Cut scores were defined as mean score for boundary vignettes. To define MIDs panelists responded to items to represent “just enough improvement to make a difference”. Average change scores served as estimates of MID.

Results

For pain interference, mobility, and upper extremity function patients set higher cut points for severity than parents, typically by 0.5 SD. Parents tended to set higher MID scores than JIA patients. Size of MID varied according to severity classification of the symptom. MIDs estimated by the panelists were typically larger than the MIDs determined using statistical methods.

Conclusion

We used a modified educational standard setting method to estimate clinically relevant cut points to classify severity for PROMIS measures of mobility, upper extremity, fatigue and pain interference. Parallel exercises identified these cut points from the perspectives of patients with JIA and parents of a child with JIA. We explored a novel means of determining MID from the patient/parent perspective. This allows for meaningful interpretation of PROMIS measures in a clinical setting. In summer 2014, the method will be repeated with clinicians serving as panelists. Results will be compared across panel groups. MIDs generated by the 3 panelist groups and those generated statistically from the longitudinal study sample will be compared.


Disclosure:

E. M. Morgan DeWitt,
None;

B. Huang,
None;

K. Barnett,
None;

A. Carle,
None;

C. Mara,
None;

K. Cook,
None.

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