the new study worksheets !
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The New Study Worksheets !. 28-May-2012. The Worksheets…. Physical Exam and Diagnostic Tests (Part A & B) Chronic GVHD Scoring Immunosuppressive Therapy Study Visit (post chronic GVHD Diagnosis) Day +365. - PowerPoint PPT PresentationTRANSCRIPT
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The New Study Worksheets !
28-May-2012
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The Worksheets…
1. Physical Exam and Diagnostic Tests (Part A & B)
2. Chronic GVHD Scoring
3. Immunosuppressive Therapy
4. Study Visit (post chronic GVHD Diagnosis)
5. Day +365
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• Worksheets have been designed to incorporate all key aspects of the NIH consensus guidelines (some aspects have been simplified)
• Inconsistencies in the Filipovich article (there are only a couple)… have been clarified with experts – The worksheets are correct
• Some explanations in the Filipovich article that are difficult to interpret have been clarified with experts – Refer to the “Green Table”
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• The worksheets are the source documents
• There are corresponding data collection forms
• W/Ss and DCFs posted on the project website:
- The worksheets are accessible from the home page under:
“GVHD Worksheets, Photos & Definitions”
- The DCFs are under:
“Study Documents” – “Data Collection Form”
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Chronic GVHD Worksheet (Part A & B)
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WhenPossible onset ofcGVHD
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What ?
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What else ?
SKIN
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If a diagnosis can be made at the time of the study visit, the assessor can complete Part A and then go on to Part B.
If biopsy and/or test results are required to confirm or exclude a diagnosis of chronic GVHD at the time of the study visit – Then the assessor should sign and date Part A and return to the study coordinator.
Once all reports back – The study coordinator asks the assessor to complete Part B. The form is then returned to the study coordinator.
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Same as the“Green Table”
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Chronic GVHD Scoring should be completed
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Chronic GVHD Scoring Worksheet
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Score Each Organ
ETCETERA...
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Key Points Re Scoring
• Scoring categories are a mix of functional aspects, clinical features and diagnostic tests
• Score all symptoms/features related to GVHD (or if cause unknown); include symptoms/features from
all clinical feature categories*
• Do not score symptoms/features known to have a cause other than GVHD
• Include symptoms of chronic and acute (i.e. the common symptoms) when scoring (this is overlap syndrome and falls under the chronic GVHD umbrella)
*Clinical feature categories are: Diagnostic, distinctive, common, other
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Key Points Re Scoring (continued)
• If there is a diagnosis of chronic GVHD in an organ other than the liver AND there are abnormal LFTs (> 2 x ULN) that are thought to be related to GVHD (even if not biopsy proven) then the liver should be scored and included when determining the GLOBAL SCORE
• Once the initial diagnosis of chronic GVHD has been confirmed – All GVHD symptoms that occur later are scored using the chronic GVHD scoring scheme – See next slide for example
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Example
• Month 6: First onset of chronic GVHD is confirmed
• Month 12: Mild Diarrhea present, <5% weight loss Alk phos > 2 X ULN (causes other than GVHD ruled out for both)
• Both organs (GI and liver) should be scored for chronic GVHD (due to previous diagnosis of chronic GVHD)
• GI score = 1; Liver score =1
• Global Score = mild
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Immunosuppressive Therapy Worksheet
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If a change is made or new immunosuppressive therapy is added due to findings at the visit -- Then both new meds/doses and immunosuppressive therapy remaining the same should be entered.
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Study Visit WorksheetUse in place of the “Part A & B” form for study visits that occur
after the initial diagnosis with cGVHD has been made
• Karnofsky• Weight• CBC• LFTs
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Day +365 Worksheet**Information entered must be for day +365 exactly**
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Questions ?