Table 3 |
|
|
Points to evaluate in assessing a Wegener's granulomatosis therapeutic study |
|
| 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? |
|
|
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Langford Arthritis Res Ther 2003 5:180 doi:10.1186/ar771 |
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