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SAT0473 Defining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the rheumatoid arthritis impact of disease (RAID)
  1. M. Dougados1,
  2. Y. Brault2,
  3. I. Logeart2,
  4. D. van der Heijde3,
  5. L. Gossec1,
  6. T. Kvien4
  1. 1Hopital Cochin, René Descatres University
  2. 2Pfizer Ltd France, Paris, France
  3. 3Leiden University Medical Center, Leiden, Netherlands
  4. 4Diakonhjemmet Hospital, Oslo, Norway

Abstract

Background The Rheumatoid Arthritis Impact of Disease (RAID) is a patient-reported outcome measure evaluating the impact of rheumatoid arthritis (RA) on patient quality of life. It comprises 7 domains that are evaluated as continuous variables from 0 (best) to 10 (worst).[1,2]

Objectives To define/identify cut-off values for disease activity states and improvement scores in order to present results at the individual level (e.g. patient in acceptable state, improved patient).

Methods Patients with definite active RA requiring anti-TNF therapy were seen at screening, baseline and after 4 and 12 weeks of etanercept therapy. Answers to “Gold standard” questions on improvement (MCII: Minimum Clinically Important Improvement) and an acceptable status (PASS: Patient Acceptable Symptom State) were collected as well as the RAID score and DAS28-ESR. Cut-offs were defined by different techniques (e.g. empirical, measurement error and gold standard anchors). The external validity of these cut-offs was evaluated using the positive likelihood ratio (LR) based on the patient’s perspective (e.g. patient’s global) and on low disease activity status (e.g. DAS28-ESR).

Results Ninety-seven (97) of the 108 recruited patients (age: 54±13 years old, female gender: 75%, rheumatoid factor positive: 81%, disease duration: 8±7 years, CRP: 18±30 mg/l, DAS28-ESR: 5.4±0.8) completed the 12 weeks of the study. The different techniques suggested thresholds ranging from 0.2 to 3 (absolute change) and from 6 to 50% (relative change) for defining MCII and thresholds from less than 1 to less than 5.6 for defining PASS. The evaluation of external validity (LR+) showed the highest LR+ was obtained with thresholds of 3 for absolute change; 50% for relative change and less than 2 for an acceptable status.

Conclusions This study showed that thresholds defined for continuous variables are closely depend on the methodological technique, justifying a systematic evaluation of their validity. Our results suggested that a change of at least 3 points (absolute) or 50% (relative) in the RAID score should be used to define a MCII and that a maximal value of 2 defines an acceptable status.

  1. Gossec L, Dougados M, Rincheval N, et al. Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative. Ann Rheum Dis 2009;68:1680-5.

  2. Gossec L, Paternotte S, Aanerud GJ, et al. Finalisation and validation of the rheumatoid arthritis impact of disease score, a patient-derived composite measure of impact of rheumatoid arthritis: a EULAR initiative. Ann Rheum Dis 2011;70:935-42.

Disclosure of Interest None Declared

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