Clinically Important Changes in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      This study will explore how patients with rheumatoid arthritis evaluate, or rate, symptom
      improvements. Physicians generally evaluate patients health and treatment benefits based on
      laboratory measures, such as the number of tender or swollen joints, duration of morning
      stiffness, grip strength, pain severity and others. Less attention is given to whether these
      treatment results are meaningful to patients. This study will examine how much of an
      improvement in pain, stiffness, function, and other symptoms is needed before patients
      consider the change an important improvement.

      Patients 18 years of age or older who were diagnosed with rheumatoid arthritis after age 16
      and who have active arthritis (6 or more tender joints) may be eligible for this study. Of
      particular interest are patients beginning treatment with prednisone, methotrexate,
      leflunomide, infliximab, or etanercept, although patients receiving any type of treatment may
      be included.

      Participants will be evaluated twice at the NIH Clinical Center, once at the start of the
      study and again at either 1 month or 4 months later, depending on the individual s treatment
      regimen. Permission will also be requested to review patients medical records for results of
      previous blood tests and x-rays. At each NIH visit, patients will undergo the following tests
      and procedures:

        -  Medical history and physical examination, including evaluation of joint swelling and
           tenderness;

        -  Questionnaires about rheumatoid arthritis symptoms;

        -  Computer-based exercise to assess preferences for various state-of-health choices;

        -  Grip strength test;

        -  Walking test on level ground, with or without the use of a cane or walker;

        -  Blood test to measure inflammation.

      At the second visit, in addition to the above procedures, participants will complete a
      questionnaire to rate the importance of changes, if any, in pain, morning stiffness, fatigue,
      joint swelling, functioning, worry, depression, and overall impressions, since the first
      visit.
    

Detailed description: 
      Proper interpretation of the results of clinical trials requires an assessment of not only
      the statistical significance of treatment differences but also the clinical importance of
      such differences. Efforts to define criteria for important improvement in rheumatoid
      arthritis (RA) activity have thus far not considered the patient's perspective. The aim of
      this project is to determine if criteria for important improvement in arthritis activity
      measures can be defined. This will be done by assessing the agreement among patients of
      judgments of important changes in arthritis activity. We will also determine if preference
      measures, which are a group of measures of the desirability of a particular state of health,
      can be used to assess when patients experience an important change in their arthritis.

      This prospective longitudinal observational study will measure changes in 12 arthritis
      activity measures, changes in preference measures, and judgments of the importance of changes
      in arthritis activity over one to four months in 300 patients with active RA. Consensus among
      patients regarding the degree of change considered important would allow group criteria for
      important improvement to be defined that were based on patients' evaluations.
    

Keywords: Utility; Health Status; Preferences; Response Criteria; Treatment; Rheumatoid Arthritis; RA