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The minimally important difference and Patient Acceptable Symptom State for the Raynaud’s Condition Score in patients with Raynaud’s phenomenon in a large randomized controlled clinical trial
  1. Puja P Khanna (pkhanna{at}mednet.ucla.edu)
  1. UCLA, United States
    1. Paul Maranian
    1. UCLA, United States
      1. Jeff Gregory
      1. MediQuest, United States
        1. Dinesh Khanna (dkhanna{at}mednet.ucla.edu)
        1. UCLA, United States

          Abstract

          Background: The Raynaud’s Condition Score (RCS) is a validated outcome measure for Raynaud’s phenomenon (RP). Our objective was to assess the minimally important difference (MID) and Patient Acceptable Symptom State (PASS) for RCS in patients with RP.

          Subjects and methods: Patients with active RP (N=162) [mean RCS > 25 (0-100 VAS)] participated in a placebo-controlled, cross over randomized clinical trial (RCT). Data from the 2 treatment groups were combined for this analysis. We administered retrospective and prospective anchors during the RCT. MID groups were defined as the group who reported being somewhat better (anchor#1) and a 1-step change from “unbearable” to “very severe” etc. (anchor#2). We considered patients as achieving PASS if they rated their Raynaud’s condition as ‘very mild’ or ‘mild’ at the last study visit.

          Results: The mean age of participants was 48.9 years and the mean baseline RCS score was 46.4. The RCS change score for the MID improvement group ranged from –13.9 to -14.3 points and PASS estimate was 34.0 points.

          Conclusion: The MID and PASS estimates for RCS are 14-15 points for improvement and 34 points, respectively on a 0-100 scale in a large RCT of patients with active RP. This information can aid in interpreting RCS in future RP trials.

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