Q105 – 142: Comorbidities

Question 105: Is there a history of mechanical ventilation?

A history of mechanical ventilation may impact the recipient’s pulmonary function post-HCT. Mechanical ventilation is any assisted ventilation on behalf of the recipient. Mechanical ventilation can occur as both an endotracheal tube and ventilator, or as a BIPAP machine with a tight-fitting mask in continuous use. The one exception to BIPAP is CPAP used for sleep apnea, which generally involves overnight use only for patients with documented sleep apnea. Therefore, do not report a CPAP used for sleep apnea, as it does not have the same implications as other forms of mechanical ventilation.

Indications for mechanical ventilation include, but are not limited to:

• Apnea with respiratory arrest (excludes sleep apnea)
• Acute lung injury
• Vital capacity < 15 mL/kg
• Chronic obstructive pulmonary disease (COPD)
• Clinical deterioration
• Respiratory muscle fatigue
• Obtundation or coma
• Hypotension
• Tachypnea or bradypnea
• COVID-19
  

Specify if the recipient was placed on mechanical ventilation at any time prior to this infusion (excluding mechanical ventilation during surgery).

Question 106: Is there a history of invasive fungal infection?

Fungal infections play a major role in the clinical outcome of transplant recipients. Specify if the recipient has a history of proven, suspected, or documented invasive fungal infection at any time prior to this infusion. For a subsequent infusion, report any documented significant fungal infections in the recipient’s medical history, starting with the preparative regimen of the previous infusion to the time prior to the preparative regimen for the current infusion.

Examples of invasive fungal infections include, but are not limited to invasive aspergillosis, zygomycosis and other molds, invasive candidiasis, cryptococcosis, endemic mycosis, other yeasts, and pneumocystosis.

Non-invasive fungal infections such as thrush and nail fungus should not be reported.

For assistance with reporting fungal infections, consult a clinician.

Question 107: Does the recipient have a known complex congenital heart disease? (corrected or uncorrected) (excluding simple ASD, VSD, or PDA repair)

The intent of this question is to determine the recipient’s history of any known complex congenital heart disease (corrected or uncorrected). Exceptions for reporting would be any simple ASD, VSD, or PDA repair. Specify if the recipient has known complex congenital heart disease.

*Prior Malignancies
Report all prior malignancies diagnosed prior to the infusion, regardless of if therapy was administered.

Question 108: Did the recipient have a prior malignancy?

Specify if the recipient has any history of a prior malignancy (treated or untreated) preceding this infusion.

Report any solid tumor(s), hematologic malignancy(ies), and / or skin malignancy(ies) that have been diagnosed at any time point prior to the infusion. A history of any benign tumor(s) should not be reported.

If the recipient is receiving an infusion for a disease that transformed from one disease to another (i.e., MDS to AML, CLL to NHL), the original malignancy should not be reported as a prior malignancy. Details regarding disease transformation are captured on the Disease Classification (2402) Form.

If it is unclear if there was a prior malignancy, seek clinician clarification.

Questions 109 – 112: Specify prior malignancy (check all that apply)

Specify the recipient’s prior malignancy(ies) and indicate if the prior malignancy was treated. Select all that apply.

If Other hematologic malignancy is selected, specify the prior hematologic malignancy.

If Other solid tumor is selected, specify the prior solid tumor.

*Comorbidities
Prior to answering Were there any co-existing diseases or organ impairment present according to the HCT comorbidity index (HCT-CI) question, review the list of co-existing disease(s) and/or organ impairments listed in Appendix J: Reporting Comorbidities.

Question 113: Were there any co-existing diseases or organ impairment present according to the HCT comorbidity index (HCT-CI)? . How I assess comorbidities before hematopoietic cell transplantation. Blood, 121(15), 2854-2863.)

The criteria for reporting comorbidities are based on Sorror, M. L. (2013). How I assess comorbidities before hematopoietic cell transplantation. Blood, 121(15), 2854-2863.

Report if the recipient has a documented history and / or current diagnosis of any of the conditions listed in Appendix J: Reporting Comorbidities.

Report all comorbidities including those that are considered complications of the primary disease for infusion. See examples below.

• A recipient with sickle cell had a stroke prior to HCT, the comorbidity to report would be Cerebrovascular disease.
• A toddler with Hurler Syndrome has cardiomyopathy, cardiac valvular disease and an ejection fraction of 45%, the comorbidities to report would be Cardiac and Heart valve disease.
  

The intent of this question is to identify serious pre-existing conditions that may influence the outcome of the infusion. For the purposes of this manual, the term “clinically significant” refers to conditions that are being treated at the time of pre-infusion evaluation or are in the recipient’s medical history and could cause complications post-infusion. Conditions listed in the recipient’s medical history that have been resolved (i.e., appendectomy), and/or that would not pose a concern during or after the infusion should not be reported.

For information regarding reporting clinically significant co-existing disease or organ impairment, see Appendix J: Reporting Comorbidities.

Question 114: Specify co-existing disease or organ impairment (check all that apply)

Select each clinically significant co-existing disease or organ impairment for this recipient. The definitions for each of the categories are taken from Sorror, M. L. (2013). How I assess comorbidities before hematopoietic cell transplantation. Blood, 121(15), 2854-2863.

The physician performing the recipient’s pre-infusion evaluation may use the HCT Co-Morbidity Index (HCT-CI) to document co-morbid conditions. For detailed information on what should and shouldn’t be reported for each category see Appendix J: Reporting Comorbidities.

Question 115: Was the recipient on dialysis immediately prior to start of preparative regimen?

Indicate if the recipient was dialysis, hemodialysis, or peritoneal dialysis dependent within approximately one month prior to the start of the preparative regimen.

*Laboratory Values Prior to Start of Preparative Regimen
Report the most recent laboratory values prior to the start of the preparative regimen, regardless of when the assessment was completed. If the assessment was performed multiple times, report the closest value prior to the start of the preparative regimen. The following are considered biomarkers according to the augmented HCT comorbidity index.

*ATG / Campath
If ATG / Campath was given prior to the preparative regimen, use the following guidelines to determine which lab values to report:
• If there are more than two days between when ATG / Campath ended and the drugs listed in the preparative regimen began, report the most recent lab values prior to the drugs listed in the preparative regimen.
• If there are two days or less between when ATG / Campath ended and the drugs listed in the preparative regimen began, report the most recent lab values prior to starting ATG / Campath.
This guidance is only applicable for reporting the serum ferritin, CRP, cystatin-C, GFR, serum albumin, and platelets in this section of the Pre-TED (2400) and does not apply when determining comorbidities and reporting additional lab values on the Recipient Baseline (2000) or other pre-infusion CIBMTR forms.

*Plasma vs Serum Samples
It is acceptable to report chemistry laboratory results based on plasma sample analysis in instances where serum sample analysis is not conducted or if it is not a standard practice at your center, even if the question text states ‘serum.’

*Reporting Lab Values
If an exact lab value is not provided (i.e., serum ferritin > X,XXX), refer to General Instructions, General Guidelines for Completing Forms for more information on how to report these values.

Questions 116 – 136: Provide the most recent laboratory values prior to the start of the preparative regimen

These questions are intended to determine the clinical status of the recipient prior to the start of the preparative regimen for stem cell transplantation. For each assessment below, indicate if the result was Known prior to the start of the preparative regimen, regardless of when the assessment was completed. If Known, specify the value, the sample collection date, and the upper limit of normal, if applicable. If testing was performed multiple times prior to the start of the preparative regimen, report the most recent laboratory value obtained for each specific test.

• Serum ferritin: Ferritin is a protein that stores, transports, and releases iron. Iron is toxic to cells, so it is stored within the ferritin protein for use. Ferritin that is too low might be indicative of iron deficiency related anemia. Ferritin that is too high might be indicative of iron overload. It is tracked for some diseases, such as hemophagocytic lymphohistiocytosis.
• C-reactive protein (CRP): C-reactive protein (CRP) is a protein made by the liver. The level of CRP increases when there is inflammation in the body. CRP tests are often used to diagnose or monitor for causes of inflammation, such as infections or certain autoimmune conditions.
• Cystatin-C: Cystatin-C is a protein produced by all nucleated cells in the body. It plays a key role in regulating the activity of proteases, which are enzymes that break down proteins. Cystatin-C is a biomarker that is primarily used to assess kidney function.
• Glomerular filtration rate (GFR): GFR is a key measure of kidney function and represents the rate at which the kidneys filter blood to remove waste and excess fluids. GFR may be measured directly through a specialized test or estimated. If the GFR is an estimated value, select GFR estimated.
  • Use the Cockcroft-Gault equation to report the calculated value, or for pediatric recipients, use the ‘Bedside Schwartz’ or Cystatin C-based equation if the actual GFR value cannot be reported.
• Serum albumin: Serum albumin is a protein found in the blood. Levels are most often reported on a chemistry panel but may occasionally be found in a separate liver function test report.
• Platelets: Platelet are formed elements within the blood that help with coagulation. A low platelet count, call thrombocytopenia, may lead to easy bleed or bruising. Thrombocytopenia may require platelet transfusions. Additionally. indicate if the recipient received a platelet transfusion within 7 days prior to testing.
  

Use the following guidelines when reporting the sample collection date and upper limit of normal:

• Date Sample Collected: Report the date the sample was collected. This date should be before the date of the start of the preparative regimen; however, laboratory values obtained on the first day of the preparative regimen may be reported as long as the blood was drawn before any radiation or systemic therapy was administered. If testing was performed multiple times prior to the start of the preparative regimen, report the value and date of the most recent test.
• Upper Limit of Normal for your Institution: Report the upper limit of normal as documented on the lab report. Normal values may vary by laboratory, so it is important to report the upper limit of normal for each assessment.
  

*Reporting More Than One Prior Solid Organ Transplant
Complete Specify organ and Year of prior solid organ transplant questions for each solid organ transplant by adding an additional instance in the FormsNet3^SM application.

Question 137: Weight loss over the preceding 12 months (optional)

Indicate the percentage of weight loss the recipient experienced during the 12 months leading to infusion.

Question 138: Montreal Cognitive Assessment (MoCA) Score (optional for ages 55 – 85 only)

The Montreal cognitive Assessment (MoCA) is a screening tool used to detect mild cognitive impairment and provides an overall score. The MoCA score ranges from 0 to 30. The higher the score, the better cognitive performance.

Report the recipient’s MoCA score prior to the start of the preparative regimen. If the assessment was performed multiple times, report the most score.

Questions 139 – 142: Did the recipient have a prior solid organ transplant?

Indicate if the recipient had a prior solid organ transplant. If Yes, specify the organ transplant, and the year of the solid organ transplant.

If Other organ is reported, specify the organ.

If the recipient did not receive a prior solid organ transplant or it is not known, report No.

For more information regarding partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.