From: Wegener's granulomatosis: current and upcoming therapies
Type and design of study | Retrospective, prospective, open-label, randomized |
 | Single center or multicenter |
Study size | For open-label trials, how many patients were included? |
 | For randomized trials, were the sample size per arm and power sufficient to draw conclusions? |
Patient population | Did the study enroll patients with other forms of vasculitis? |
 | How was Wegener's granulomatosis diagnosed? |
 | Were patients enrolled at initial diagnosis or relapse? |
Site of organ involvement | What was the distribution of organ involvement? |
 | Were there any patients who had disease isolated to nonmajor organ sites such as the skin, the joint, or the sinus? |
 | Were patients enrolled for sites known to be of limited medical responsiveness (i.e. subglottic stenosis)? |
 | Were methods in place to rule out other processes that could have the appearance of active disease? |
Definition of outcome measures | How did the study define active disease, remission, and relapse? |
 | Were outcome measures clearly defined in the methods? |
Concurrent therapies | Were immunosuppressive therapies used concurrently with the agent or regimen being studied? |
Standardization | Did all enrolled patients receive a standarized dose and duration of the study agent? |
 | Was the glucocorticoid dose and taper standardized? |
 | At what point in time did patients enter the study (i.e. at beginning of induction or at remission)? |
Study duration | What was the median follow-up time? |
 | Were patients followed for sufficient duration to observe relapses? |