A transplant center designated as a Comprehensive Report Form center will submit data on the Pre-TED and Pre-TED Disease Classification Forms, followed by either the Post-TED Form or the Comprehensive Report Forms. The type of follow-up forms required for a specific recipient is determined by the CIBMTR’s form selection algorithm (see Section 1 in the Center Reference Guide).
The Post-Infusion Form (2100) must be completed at the following time points: 100 days, 6 months, annually for 6 years post-HCT, and biennially thereafter. This form should be completed as closely to these time points as possible. The following recipient data should be collected from an actual examination (or other recipient contact) by the transplant center physician or the local physician who is following the recipient post-HCT: vital status, hematopoietic reconstitution post-HCT, neutrophil recovery, platelet recovery, current hematologic findings, immune reconstitution, chimerism studies, engraftment syndrome, acute Graft-versus-Host Disease (GVHD), chronic GVHD, infections, organ function, new malignancy, functional status, and subsequent HCT.
If a recipient receives a subsequent HCT between time points (100 day, 6 months, annually), the CRF form sequence will start over again with another Pre-TED.
However, if the recipient receives an autologous HCT as a result of a poor graft or graft failure, the CRF form sequence will not start over again. Generally, this type of infusion (autologous rescue) is used to treat the recipient’s poor graft response, rather than to treat the recipient’s disease, and is, therefore, not considered a subsequent HCT for reporting purposes.
Contact CIBMTR Center Support if the subsequent Pre-TED does not come due automatically.
Lost to Follow Up:
Occasionally, centers may lose contact with recipients for a variety of reasons, including the recipient moving, changing physicians, or death. If contact with a recipient appears lost, please consider calling the recipient at home or work, sending a letter, communicating with the treating or referring physician, or contacting the hospital billing department. If no documentation exists and several unsuccessful attempts have been made to contact the recipient, they are considered lost to follow-up and the form may be marked as such using the Lost to Follow-Up Tool in FormsNet3 for each reporting period in which no contact exists.
Q1-5: Vital Status
Q6-12: Granulopoiesis / Neutrophil Recovery
Q13-16: Megakaryopoiesis / Platelet Recovery
Q17-25: Growth Factor and Cytokine Therapy
Q26-35: Current Hematologic Findings
Q36-51: Immune Reconstitution
Q52-69: Chimerism Studies
Q70-80: Engraftment Syndrome
Q81-130: Acute Graft vs. Host Disease
Q131-200: Chronic Graft vs. Host Disease
Q201-207: Current GVHD Status
Q208-223: Infection Prophylaxis
Q248-309: Organ Function
Q310: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder
Q311-334: Functional Status
Q335-338: Subsequent HCT
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
|5/19/2022||2100:Post-Infusion Follow-Up Form||Modify|| Updated the ‘go to’ instructions for Q311: Report Yes if the plan was to complete all conditioning, infusions, and recovery in the outpatient setting. If the plan was to admit the patient for any part of the transplant, report No and continue with question
|5/18/2022||2100:Post-Infusion Follow-Up Form||Add||Combined Follow-Up blue instruction box added to questions 6, 13, 17, 26, 70, 208, 224, 241, 310, and 325 for clarification|
|5/6/2022||2100:Post-Infusion Follow-Up Form||Modify||Clarification added on when to report organ impairments in question 280: Indicate if any of the organ impairments or disorders listed were diagnosed during the reporting period. If the recipient developed an impairment during the reporting period, select the impairment / disorder, enter the date of diagnosis, and answer any additional questions pertaining to the impairment / disorder. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported. *Do not report organ impairments or disorders diagnosed prior to the start of the preparative regimen infusion /or in a prior reporting period.|
|5/6/2022||2100:Post-Infusion Follow-Up Form||Modify|| Updated instructions on when to report the antiviral start date as 7 days prior to prep in Q213 – 215: Report the first antiviral drug administered and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antiviral drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. If the start date is prior to the start of the preparative regimen and the start date is unknown
|4/11/2022||2100:Post-Infusion Follow-Up Form||Add||Instructions added to question 246 on how to report the vaccine brand when not known for clarification: Specify the type of COVID-19 vaccine the recipient received in the reporting period. If the recipient received a type that is not listed, select Other type and specify the vaccine. If the vaccine type is unknown, leave the field blank and override the error as Unknown.|
|4/11/2022||2100:Post-Infusion Follow-Up Form||Add|| Reporting COVID-19 Reinfection blue box and possible COVID-19 reporting scenarios added above Q224 for clarification: Reporting COVID-19 Reinfection: There have been cases of recipients recovering from COVID-19 infection, only to later test positive again. For CIBMTR purposes, a new COVID-19 infection should be reported when a recipient tests positive again >21 days from resolution (resolution defined as no signs or symptoms of infection, or a negative diagnostic test).; : Do NOT report an infection in the following scenarios:
|3/27/2022||2100:Post-Infusion Follow-Up Form||Remove|| Updated the blue box above question 131 to explain when the acute GVHD section is required to be completed:Autologous Transplants: If this was an autologous infusion
|3/27/2022||2100:Post-Infusion Follow-Up Form||Remove|| Updated the blue box above question 81 to explain when the acute GVHD section is required to be completed: Autologous Transplants: If this was an autologous infusion
|2/1/2022||2100:Post-Infusion Follow-Up Form||Modify|| Updated the red box above question 311 to explain when questions 311 – 315 will come due: Questions 311 – 315
|8/12/2021||2100:Post-Infusion Follow-Up Form||Add||Updated the “Lower GI GVHD and Stool Output Not Documented” blue box with instructions that were missing from the prior 2100: If diarrhea is attributed to acute GVHD during the reporting period, but the volume of stool output is not documented, leave the lower GI stage data field blank, override the FormsNet3 error as “not documented,” and specify the volume of stool output was not documented. In this case, report Not applicable for the overall grade stage 4 acute skin GVHD, stage 4 acute liver GVHD, or an extreme decrease in performance status or stage 2 or 3 acute liver GVHD was also documented at the time point being reported (at diagnosis or maximum grade during the current reporting period).|
|7/23/2021||2100:Post-Infusion Follow-Up Form||Modify||Version 7 of the 2100: Post-Infusion Follow-Up section of the Forms Instructions Manual released. Version 7 corresponds to revision 7 of the Form 2100|
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