The New Study Worksheets !

28-May-2012

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

• 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”

• 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”

Chronic GVHD Worksheet (Part A & B)

WhenPossible onset ofcGVHD

What ?

What else ?

SKIN

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.

Same as the“Green Table”

Chronic GVHD Scoring should be completed

Chronic GVHD Scoring Worksheet

Score Each Organ

ETCETERA...

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

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

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

Immunosuppressive Therapy Worksheet

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.

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

Day +365 Worksheet**Information entered must be for day +365 exactly**

Questions ?