q108 Q2 Q3 Q4 Q1 2009 Q2 2009 Q3 2009 Q4 2009
 
Welcome to the 2009 Q1 Scleroderma QuERI Quarterly Update,
Please select a category below or scroll down to read the newsletter.
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Site Locations
Study Progress
Number of Sites
Number of Patients

 


Early Termination Status
Important Upcoming Change
Additional QuERI data


Needs Assessment Survey


 


Scleroderma QuERI Study Statistics
- site locations

29:
Initial number of participating sites
27:
Current number of active sites
213:
Total patients enrolled


Scleroderma QuERI Study Progress

FIRST PATIENT, FIRST VISIT:
FIRST PATIENT, LAST VISIT:
LAST PATIENT, FIRST VISIT:
LAST PATIENT, LAST VISIT:
24 July, 2006
24 October, 2009
27 September, 2007
27 December, 2010
Out of 213 patients enrolled, 96% completed baseline visit, 90% completed 6 months follow up visit and 75% completed 1 year follow up visit.


 


Scleroderma QuERI Study Statistics:
Number of sites (31 March, 2009)
Follow up visit achieved / Actual visit completion

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Scleroderma QuERI Study Statistics:
Number of patients
Follow up visit achieved / Actual visit completion (31 March, 2009)

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Early Termination Status (31 March, 2009)

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eCRF CORNER
IMPORTANT UPCOMING CHANGE

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We strongly encourage reporting of the prescheduled visit type data and sign off by the PI within one month of the actual patient visit.
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The recommended time frame for the prescheduled follow up visits is: 6 months (5-7 months); 1 year (10-14 months); 2 years (22-26 months); 3 years (33-39 months)
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It is left to the site investigator’s discretion to consider the out of range data as pertaining to a 1, 2 or 3 year follow up and report it under the applicable follow up visit section of the eCRF.
•

All test data ( Echo, PFTs, HRCT, RHC, contingent testing ) not available at the current follow up visit are to be reported at the next follow up visit.

 


 




•

Medication updates must be reported at each follow up visit. Please update the PAH indication for all medication if not done so already.
•

Patients with no data available for a certain follow up visit type may continue in the study with the rest of the pre-scheduled follow up visits.
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The”Early Termination” page is to be completed for patients early discontinued from the study and the reason for discontinuation is to be reported.
•

Once a patient has been confirmed with PAH based on the Right Heart Catheterization (RHC) results, please complete the “Final Classification” page.

 


 


The following data has recently been reviewed by the Scleroderma Pulmonary Hypertension Quality Enhancement Research Initiative (QuERI) steering committee in anticipation of the abstract submission for the upcoming meeting of the American College of Rheumatology.

Results: (Median, 25th and 75th percentile): Patients enrolled were 57 years old (49, 66), 90% female. Raynaud was present in 87.0%, duration 9 years (4,15). In spite of specific clinical focus on lung, CXR was performed in only 43.0% and was abnormal in 36.0%. V/Q scan was done in only 1% and HRCT in only 37.2%. PFT was performed in 82.6% and showed DLCO <55% predicted in 27.1%, and FVC/DLCO ratio >1.4 in 44.6%. Doppler echocardiogram was done in 85.0% of patients and revealed tricuspid jet of >3 m/sec in 11.1% and estimated RVSP >40 mm Hg in 20.0%. Right heart catheterization was performed in only 4.8% of patients. Practice setting influenced use of testing:

 
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14 were treated with endothelin receptor antagonists and 8 were receiving chronic PDE-5 inhibitors although only 5 were treated for “PAH indication.” ILD was confirmed by PFT and HRCT in 23 (96%) of 24 patients receiving agents of putative benefit including cyclophosphamide (6) and mycophenolate mofetil (18).

Conclusions: This preliminary assessment suggests that certain basic essential diagnostic tests, such as right heart catheterization for PAH, continue to be underutilized. The SSc QuERI offers stricter guidelines, adherence to which could optimize management of these high-risk patients.