Appendix J: Reporting Comorbidities

CIBMTR collects comorbidities data based on criteria from the Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI), which was developed and validated by investigators at the Fred Hutchinson Cancer Research Center in Seattle, Washington. The HCT-CI was developed to identify comorbidities relevant to transplant and act as a tool for risk assessment before allogeneic hematopoietic stem cell transplantation. While the criteria were originally developed for use in the adult, allogeneic population, there is utility in collecting these data for all transplant populations, and used in conjunction with other relevant risk factors, these data are useful in determining risk for transplant for the purposes of predicting expected outcomes.

*Pediatric Recipients (HCT and CT)
The comorbidity criterion has been updated to include criteria for both adult and pediatric recipients. When discrepancies are identified, seek physician clarification or submit a ticket to CIBMTR Center Support.

What to Report

Report a comorbidity in all the following areas if any of the specified criteria are met.

Comorbidity	Definition and/or criteria	Where to look within the EMR¹
Arrhythmia	Adults and Pediatrics: Any history of (but not limited to) one or more of the following which required antiarrhythmic treatment: Bradycardia (< 50 bpm and sustained) Tachycardia (> 120 bpm and sustained) Atrial fibrillation Sick sinus syndrome Ventricular arrhythmias	EKG Medical administration record History and physical Progress notes
Cardiac (Cardiovascular disease)	Adults and Pediatrics: The presence of one or more of the following: Any history of coronary artery disease (one or more vessels requiring medical treatment, stent, or bypass), Any history of myocardial infarction, or Any history of congestive heart failure (regardless of an LVEF >50% at the start of preparative regimen), or LVEF ≤ 50% (or a shortening fraction (SF) of < 26% for pediatric cases) on most recent evaluation prior to the start of the preparative regimen / lymphodepleting therapy	Echocardiogram Medical administration record Past surgeries / procedures History and physical Progress notes
Cerebrovascular disease	Adults and Pediatrics: Any history of one or more of the following: Transient ischemic attack Cerebrovascular accident/stroke Subarachnoid, subdural, epidural, or intraparenchymal hemorrhage	History and physical Progress notes
Diabetes	Adults and Pediatrics: Current (within 4 weeks prior to HCT / CT) history of diabetes or steroid-induced hyperglycemia requiring insulin or oral hypoglycemics, not controlled by diet alone.	History and physical Progress notes Medical administration record
Heart valve disease	Adults and Pediatrics: The presence of one or more of the following, found on the most recent heart evaluation by an echocardiogram: At least a moderate or severe degree of valve stenosis, regurgitation or insufficiency as determined by echo, whether the valve is mitral, aortic, tricuspid or pulmonary; Prosthetic mitral or aortic valve; Symptomatic mitral valve prolapse	Echocardiogram History and physical Progress notes
Hepatic, mild	Adults and Pediatrics: Any one or more of the following: Chronic hepatitis Any diagnosed history of Hepatitis B or Hepatitis C Bilirubin > ULN to 1.5 x ULN* AST or ALT > ULN to 2.5 x ULN*	Liver function tests (hepatic panel) History and physical Progress notes Infectious disease markers
Hepatic, moderate/severe	Adults and Pediatrics: Any one or more of the following: Liver cirrhosis Bilirubin > 1.5 x ULN* AST or ALT > 2.5 x ULN*	Liver function tests (hepatic panel) History and physical Progress notes
Infection	Adults: The presence of one or more of the following requiring therapeutic antimicrobial / antifungal / antiviral treatment starting prior to the preparative regimen / lymphodepleting therapy (or prior to Day 0 if no preparative regimen / lymphodepleting therapy is being given) with a recommendation to continue treatment after Day 0: - Documented infection, - Fever of unknown origin, - Pulmonary nodules suspicious for fungal pneumonia - A positive PPD test requiring prophylaxis against TB - Infection requiring antimicrobial treatment continued after Day 0 Pediatrics: The presence of one or more of the following: - History of invasive fungal infection (refer to Is there a history of invasive fungal infection? manual instructions located under the 2400 Comorbid Conditions section for further clarification) - Infection requiring antimicrobial treatment continued after Day 0 Do not report an infection comorbidity if the infection resolved prior to infusion and there was a recommendation to continue, or the recipient continued medication post-infusion as prophylaxis	Infection tests Purified protein derivative (PPD) test Radiologic scans History and physical Progress notes Medical administration record
Inflammatory bowel disease	Adults and Pediatrics: Any history of: Crohn’s disease or Ulcerative colitis requiring treatment	History and physical Progress notes Medical administration record
Obesity	Adults: Body mass index (BMI) > 35.00 kg/m2 Pediatrics: BMI-for-age ≥ 95% during the pre-infusion work-up period. If only the BMI is known, refer to the following link to determine the BMI-for-age: https://www.cdc.gov/growthcharts/. Evaluation of the obesity comorbidity is based on the most recent measurement of the BMI (or weight and height needed for the calculation of BMI) prior to the start of the preparative regimen / lymphodepleting therapy (or prior to Day 0 if preparative regimen / lymphodepleting therapy was not given).	History and physical Progress notes Weight and / or BMI flow sheet
Peptic ulcer	Adults and Pediatrics: Any history of peptic ulcer (gastric or duodenal) confirmed by endoscopy or radiologic diagnosis and the recipient has or is receiving treatment.	History and physical Progress notes Endoscopy results Radiologic scans Medical administration record
Psychiatric disturbance	Adults and Pediatrics: Any psychiatric illness requiring treatment, including regular counselling / therapy sessions, within four weeks prior to the pre-infusion work-up period. Treatment also includes the recommendation / prescription of medication and / or regular counselling / therapy sessions but the recipient is non-compliant. Examples of psychiatric disturbances include, but are not limited to, depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), schizophrenia, or bipolar disorder. Do not report for recipients only receiving treatment (including counselling / therapy sessions) “as needed” or PRN	Medical administration record History and physical Progress notes
Pulmonary, moderate	Adults and Pediatrics: Any one or more of the following at the time of pre-infusion evaluation: Adjusted DLCO 66-80% FEV1 66-80%** Dyspnea on slight activity attributed to pulmonary disease and not anemia	History and physical Progress notes Pulmonary function tests
Pulmonary, severe	Adults: Any one or more of the following at the time of pre-infusion evaluation: - Adjusted DLCO ≤ 65% - FEV1 ≤ 65%** - Dyspnea at rest attributed to pulmonary disease and not anemia - Requires intermittent or continuous supplemental oxygen Pediatrics: Any one or more of the following at the time of pre-infusion evaluation: - Adjusted DLCO ≤ 65% - FEV1 ≤ 65%** - Dyspnea at rest attributed to pulmonary disease and not anemia - Requires intermediate or continuous supplemental oxygen - History of mechanical ventilation (refer to Is there a history of mechanical ventilation (excluding COVID-19 (SARS-CoV-2)? manual instructions located under the 2400 Comorbid Conditions section for further clarification) Do not report if intubated due to premature birth for <24 hours.	History and physical Progress notes Pulmonary function tests
Renal, moderate/severe	Adults: Any one or more of the following: - Serum creatinine > 2 mg/dL or 177 µmol/L - On dialysis in pre-infusion evaluation period - Prior renal transplant recipient Pediatrics: Any one or more of the following: - Serum creatinine > 2 mg/dL or 177 µmol/L - eGFR <60 ml>2 (by Bedside Schwartz calculation for <18 years old, ckd-epi calculation for ≥18 old) - On dialysis in pre-infusion evaluation period - Prior renal transplant recipient	History and physical Progress notes Serum creatinine tests
Rheumatologic	Adults and Pediatrics: Any history of rheumatologic disease requiring treatment including: Systemic lupus erythematosus Rheumatoid arthritis Sjogren’ Polymyositis Dermatomyositis Mixed connective tissue disease Polymyalgia rheumatic Polychondritis Psoriatic arthritis Sarcoidosis Vasculitis syndromes	Medical administration record History and physical Progress notes
Prior malignancy	Adults and Pediatrics: Any solid tumor(s),hematologic malignancy(ies), and / or skin malignancy(ies) that have been treated at any time point in the recipient’s past history. Treatment includes surgery and/or resection. 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 comorbidity. Details regarding disease transformation will be captured on the Pre-TED Disease Classification (2402) Form. For more information regarding disease combinations and transformations, refer to the Common Disease Combinations and Common Disease Transformations tables in the Primary Disease for HCT section of the Pre-TED Disease Classification (2402) Form.	Medical administration record Past surgeries / procedures History and physical Progress notes

¹ Examples of where to find source documents within the EMR; however, this will vary from institution to institution. Seek physician clarification on where to find this information, as needed.
(*) ULN refers to upper limit of normal for respective laboratory study
(**) If the PFT lists both a “control” FEV1 and “post-dilator” FEV1, the “control” FEV1 should be used to determine if a pulmonary comorbidity is present.

*Prior Skin Malignancies
All prior skin malignancies that have been treated should be reported as a Prior malignancy comorbidity; however, only melanoma will be given an HCT-CI score. If an Other skin malignancy (basal cell, squamous) is selected, an HCT-CI score is not given.

*Hepatic and Renal Comorbidities
In addition to the guidelines listed, include the following time-specific guidelines when reporting hepatic and renal comorbidities
Hepatic Comorbidity: The assessment of liver function tests (ALT, AST and/or Total Bilirubin) has to include at least two values per test (i.e., ALT, AST, or total bilirubin) on two different days (these values do not have to be consecutive values) within a period extending between day -24 and the start of the preparative regimen. If only a single value is available in this time period, use values available between days -40 & -25 as the second value. In addition, if the liver function test values closest to the start of the preparative regimen are within normal limits, a hepatic comorbidity should not be reported. When determining the severity of the hepatic comorbidity, the value closest to the start of the preparative regimen / lymphodepleting therapy should be used.
Renal (Moderate/Severe) Comorbidity: Serum creatinine > 2 mg/dL or > 177 μmol/L, as detected in at least two lab values on two different days (these values do not have to be consecutive values) within a period extending between day -24 and the start of the preparative regimen. If only a single value is available in this time period, use values available between days -40 & -25 as the second value. If the serum creatinine value closest to the start of the preparative regimen is within normal limits, a renal (moderate/severe) comorbidity should not be reported.

² Sorror, M. L. (2013). How I assess comorbidities before hematopoietic cell transplantation. Blood, 121(15), 2854-2863.

Determine relevant comorbidities through careful review of the recipient medical record. Reviewed documentation should include the recipient’s past medical history and objective data from the pre-infusion work-up, including pulmonary function tests, echocardiogram, body weight, and laboratory results. The recipient medication list should be correlated with the past medical history to verify there are not any medications that do not align with the recipient’s medical history; if there were to be medications commonly used for a certain purpose not listed in the medical history, further clarify if a relevant comorbidity is present. However, if the medical record remains ambiguous, after careful review, as to whether a condition meets the criteria for reporting comorbidity, do not report.

Report all comorbidities meeting criteria at time of pre-infusion evaluation. This may include comorbidities secondary to the primary infusion disease or conditions resulting from prior therapy and persisting or meeting criteria for reporting at the time of infusion.

For instances in which the pulmonary function testing report does not correct diffusing capacity of carbon monoxide for hemoglobin, use the Dinakara equation to correct.

* To correct an uncorrected DLCO:
corrected DLCO= uncorrected DLCO/(0.06965*hemoglobin)
where hemoglobin is measured in g/dL

What not to report

The following conditions are not relevant transplant outcomes or risk, and should not be reported under the comorbidities section.

Acne Behavioral issues Benign tumor (removed) Bulging discs Cataracts Concussions Congenital alopecia Deafness or hearing loss Fibromyalgia Fractures Gallbladder (stones, sludge) Gastric bypass surgery Gastritis GERD Gestational diabetes (resolved) Glaucoma Glomerulosclerosis (assume Cr okay) Glucose-6-phosphate dehydrogen Glucose intolerance Gout Headaches (chronic) Hemorrhoidectomy Hemorrhoids Hernia Hypercholesterolemia Hyper-eosinophilia (if not disease related) Hyperlipidemia Hyperparathyroidism Hypertension Hypertriglyceridemia Hysterectomy Insomnia Iron deficiency anemia

Iron deposition or overload Irritable bowel syndrome (IBS) Kidney stones Knee arthritis Knee surgery Lyme disease Macular degeneration Malabsorption Malnutrition Meniere’s disease Menorrhagia Microalbuminuria Migraines Multiple Sclerosis Non-alcoholic steatohepatitis (NASH) Prior h/o necrotizing fasciitis Neonatal jaundice Nephritis Nephrolithiasis Neuropathy Neurosyphilis Neutropenic colitis Obesity with BMI ≤ 35.00 kg/m2 Osteoarthritis Osteomyelitis Osteopenia Osteoporosis Pancreatitis Paraplegic Paresthesias Parkinson’s Disease Psoriasis Raynaud’s Disease

Restless leg syndrome Rosacea Scoliosis Seizure disorders Shingles Sleep apnea Solitary kidney Spastic colon Splenectomy Subdural hematoma Syncope Thalassemia (minor or trait) Thyroidectomy Thyroid nodules Tonsillectomy Tracheoesophageal fistula Transient arrhythmia, untreated Traumatic brain injury (TBI) Tremors Tubal ligation Uterine fibroids Valve insufficiency (mild) Valve prolapse (asymptomatic) Valve regurgitation (mild) Vasculitis Vasectomy Vena cava filter Vertigo Vision (blindness, blurred) Vitamin deficiency (B12, D) Vitiligo Whipple procedure Wisdom tooth extraction

Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. In addition to documenting the changes within each manual section, the most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

Date	Manual Section	Add/Remove/Modify	Description
12/20/2023	Appendix J: Reporting Comorbidities	Add	Prior Skin Malignancy blue box added: Prior Skin Malignancies: All prior skin malignancies that have been treated should be reported as a Prior malignancy comorbidity; however, only melanoma will be given an HCT-CI score. If an Other skin malignancy (basal cell, squamous) is selected, an HCT-CI score is not given.
12/20/2023	Appendix J: Reporting Comorbidities	Add	Clarification added for mild hepatic criteria: Hepatic, mild: Any one or more of the following: Chronic hepatitis Any diagnosed history of Hepatitis B or Hepatitis C
10/5/2023	Appendix J: Reporting Comorbidities	Add	Further clarification added for pediatric invasive fungal infections: Infection: Pediatrics: The presence of one or more of the following: - History of invasive fungal infection (refer to Is there a history of invasive fungal infection? manual instructions located under the 2400 Comorbid Conditions section for further clarification) - Infection requiring antimicrobial treatment continued after Day 0 Do not report an infection comorbidity if the infection resolved prior to infusion and there was a recommendation to continue, or the recipient continued medication post-infusion as prophylaxis
10/5/2023	Appendix J: Reporting Comorbidities	Add	Further clarification added for pediatric mechanical ventilation: Pulmonary, severe: Pediatrics: Any one or more of the following at the time of pre-infusion evaluation: - Adjusted DLCO ≤ 65% - FEV1 ≤ 65%** - Dyspnea at rest attributed to pulmonary disease and not anemia - Requires intermediate or continuous supplemental oxygen - History of mechanical ventilation (refer to Is there a history of mechanical ventilation? manual instructions located under the 2400 Comorbid Conditions section for further clarification) Do not report if intubated due to premature birth for <24 hours.
8/28/2023	Appendix J: Reporting Comorbidities	Add	Version 4 of Appendix J added. This version is an overhaul of the appendix for easier comorbidity reporting

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