May 2018 Forms Instruction Manual Updates

In case you missed them, here are the changes made to the Forms Instruction Manual during the month of May. Check the Getting Started  page of the Forms Instruction Manual for a list of the most recent updates. Updates made after March 2015 are always available for reference in the Historical Manual Updates  section.

Date
Manual Section
Add/
Remove/
Modify
Description
5/21/18
2400: Pre-TED

Modify
Added (in red below) and removed (struck out below) text from the instructions for reporting comorbidities (questions 98-134).
Arrhythmia: Any history of 
any type of arrhythmia that has necessitated the delivery of a specific antiarrhythmic agent. Examples include, but are not limited to,  atrial fibrillation or flutter, sick sinus syndrome, or and ventricular arrhythmias.  requiring treatment.
Cardiac: Any history of coronary artery disease (one or more vessel coronary artery stenosis requiring medical treatment, stent, or bypass graft), congestive heart failure, myocardial infarction, 
and /  or ejection fraction ≤ 50%  (shortening fraction < 26  for pediatric recipients)% on the most recent test.
Cerebrovascular disease: Any history of transient ischemic attack, subarachnoid hemorrhage, 
and /  or cerebrovascular accident  cerebral thrombosis embolism, or hemorrhage .
Diabetes: 
Diabetes or steroid-induced hyperglycemia requiring  continuous  treatment with insulin or oral hypoglycemics in the last 4 weeks. but not diet alone
Heart valve disease: 
Moderate or severe valve stenosis or insufficiency (mitral, aortic, tricuspid, or pulmonary) as determined by echocardiogram, prosthetic mitral or aortic valve, and / or symptomatic mitral valve prolapse.  Except asymptomatic mitral prolapse.
Psychiatric disturbance: 
The presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the last four weeks. Examples include, but are not limited to,  depression, anxiety, bipolar disorder, or and schizophrenia requiring psychiatric treatment in the last 4 weeks.
Pulmonary (moderate): Corrected diffusion capacity of carbon monoxide (e.g., DLCOc, DLCOcorr, DLCO) and/or FEV1 66-80% or dyspnea on slight activity at transplant. 
Use the Dinakara equation below to determine the  DLCO c if only an uncorrected value is provided. For recipients assessed by a postbronchodilator test, only the prebronchodilator FEV1 values are considered for evaluation of pulmonary comorbidity.
Dinakara Equation:  DLCO c = {uncorrected  DLCO } / [0.06965 x {hemoglobin g/dL}]
Pulmonary (severe): Corrected diffusion capacity of carbon monoxide (e.g., DLCOc, DLCOcorr, DLCO) and/or FEV1 ≤ 65% or dyspnea at rest or requiring oxygen at transplant. 
Use the Dinakara equation above to determine the  DLCO c if only an uncorrected value is provided. or recipients assessed by a postbronchodilator test, only the prebronchodilator FEV1 values are considered for evaluation of pulmonary comorbidity.
Renal (moderate/severe): Serum creatinine > 2 mg/dL or > 
176.8  177 μmol/L, or on dialysis at transplant, or prior renal transplantation. See note in question 97.
5/10/18
2100: Post-HCT Follow-Up
Add
Added Fecal Microbiota Transplant note box to acute (questions 185-233) and chronic (questions 328-399) GVHD treatment instructions.
5/10/18
LYM Response Criteria
Add
Added "Relapsed Disease" to "Progressive Disease" criteria and included clarification on when to report these disease status.
5/7/18
2553: VOD/SOS
Add
Added an example on how to report the planned total daily dose for Defibrotide
5/7/18
2400: Pre-TED
Modify
Modified language on how to report Drugs After Transplant, replaced "day 0" with "transplant" to clarify how to report drugs planned for day 0
5/7/18
2400: Pre-TED
Add
Added note box to capture all comorbidities including those that are considered complications of the primary disease for transplant and provided examples
5/1/18
2150: Viral Infections
Add
Version 1 of the 2150: Viral Infections section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2150.
5/1/18
2046: Fungal Infection Pre-Infusion Data
Modify
Version 2 of the 2046: Fungal Infection Pre-Infusion Data section of the Forms Instructions Manual released. Version 2 corresponds to revision 5 of the Form 2046.
5/1/18
2146: Fungal Infection Post-Infusion Data
Modify
Version 2 of the 2146: Fungal Infection Post-Infusion Data section of the Forms Instructions Manual released. Version 2 corresponds to revision 4 of the Form 2146.
5/1/18
2565: Sanofi Mozobil Supplemental Data Collection
Add
Version 1 of the 2565: Sanofi Mozobil Supplemental Data Collection section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2565.

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