OMERACT is the acronym for an international, informally organized network initiated in 1992 aimed at improving outcome measurement in rheumatology. Chaired by an executive committee, it organizes consensus conferences in a 2-yearly cycle that circles the globe. Data driven recommendations are prepared and updated by expert working groups. Recommendations include core sets of measures for most of the major rheumatologic conditions. Since 2002 patients have been actively engaged in the process.

The OMERACT patient reported outcomes (PRO) working group evaluated the methodologies for measuring responsiveness to change at the Outcome Measures in Rheumatology (OMERACT) 10 meeting. The outcome measures used in PRO studies are often expressed as continuous data at the group level (e.g., mean change in pain on a 0-100 visual analog scale). This is difficult to interpret and cannot easily be translated to the individual level of response. When interpreting scores at the individual level, it is important to take into account the following 4 main concepts: (1) improvement; (2) status of well-being; (3) onset of action; and (4) sustainability. Information from clinical trials on how many patients showed a response, what the level of response was, and how many patients are doing well, would be extremely useful for physicians. The objective of this article is to outline how continuous data may be reported in a clinically relevant manner. We will describe 5 techniques of reporting continuous variables in clinical studies and discuss the relevance of each.

We sought to identify instruments assessing sleep quality that measure the domains of sleep applicable to rheumatoid arthritis (RA) patients and are feasible to use and have appropriate reliability, validity, and responsiveness properties. A systematic review of sleep instruments was conducted. In particular, domains related to sleep that were assessed in the instruments were identified and evaluated. Feasibility characteristics and psychometric properties of instruments were reviewed. At OMERACT 9, the preparatory work was described at the plenary session of the Patient Perspective Workshop, and the tasks of 3 breakout groups in ranking and scoring the domains and sleep instruments were outlined. Each breakout group considered different aspects of sleep: sleep domains, feasibility, and psychometric properties. The rapporteur for each breakout group reported back to the plenary on the domains and sleep instruments that achieved the highest rank/score. The systematic review identified 45 sleep instruments of interest. Based on these instruments, 14 domains of sleep were identified. The top ranked domains were: Sleep Adequacy (1), Sleep Maintenance (2), Sleep Initiation (3) and Daytime Functioning (4). The top ranked instruments on feasibility were: Athens Insomnia Scale (2.3), Medical Outcome Study (MOS) Sleep (4.0), Insomnia Severity Index (4.9), and Women's Health Insomnia Rating Scale (5.5). The highest scored instruments on psychometric properties were: Athens Insomnia Scale (13.6), Sleep Assessment Questionnaire (13), Pittsburgh Sleep Diary (12), and MOS Sleep (11). Sleep domains have been reviewed, and several sleep instruments have been identified. These instruments should be considered for use in planned clinical trials of RA patients to assess their applicability.