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.
Date of Assessment:
Report the date HCT-CI Score was assessed. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Per protocol an HCT-CI score assessment is required within 45 days prior to the anticipated start of the conditioning regimen. If the assessment date entered is outside of those parameters a protocol deviation should be logged in the EDC.
If this field is marked as “Intentionally Left Blank” a protocol deviation should be logged in the EDC.
If the date entered is a future date, a query will appear in the EDC.
Were there any co-existing diseases or organ impairment present, according to the HCT comorbidity index (HCT-CI) at the time of screening?:
Indicate if there were any co-existing disease or organ impairments present as “Yes” or “No”.
If this question is answered Yes, additional fields will appear in the EDC to indicate which co-existing disease or organ impairments were present.
If this question is answered No, no other fields on this form are expected to be answered.
Specify co-existing diseases or organ impairment
For each co-existing disease or organ impairment indicate whether present at time of assessment as “Yes” or “No”.
| Co-Existing Disease or Organ Impairment | HCT-CI Score if Answered Yes | HCT-CI Score if Answered No |
|---|---|---|
| Arrhythmia | 1 | 0 |
| Cardiovascular comorbidity | 1 | 0 |
| Inflammatory bowel disease | 1 | 0 |
| Diabetes or steroid-induced hyperglycemia | 1 | 0 |
| Cerebrovascular disease | 1 | 0 |
| Psychiatric disorder | 1 | 0 |
| Mild hepatic comorbidity | 1 | 0 |
| Obesity | 1 | 0 |
| Infection | 1 | 0 |
| Rheumatologic comorbidity | 2 | 0 |
| Peptic ulcer | 2 | 0 |
| Renal comorbidity | 2 | 0 |
| Moderate pulmonary comorbidity | 2 | 0 |
| Prior malignancy | 3 | 0 |
| Heart valve disease | 3 | 0 |
| Moderate/severe hepatic comorbidity | 3 | 0 |
| Severe pulmonary comorbidity | 3 | 0 |
HCT-CI Score: [SYSTEM GENERATED]
HCT-CI Score is recorded as numeric up to two digits, derived from the answers provided above for each co-existing disease or organ impairment. The below table indicates the score assigned to each disease or impairment based on the answer to that question.
Comorbidity Definitions
1. Arrhythmia (score 1). A score of 1 is assigned for any type of arrhythmia that has necessitated the delivery of a specific antiarrhythmia treatment at any time in the patient’s past medical history. Examples include atrial fibrillation or flutter, sick sinus syndrome, or ventricular arrhythmias. A score is assigned even if the patient was in normal sinus rhythm at the time of data acquisition or at the landmark date. No score is assigned to transient arrhythmias that never required treatment.
2. Cardiovascular Comorbidity (score 1). A maximal score of 1 is assigned for cardiovascular comorbidity in the presence of 1 or more of the following 3 clinical presentations.
a. Coronary artery disease. This is based on the presence of a documented diagnosis of chronic exertional angina, unstable angina, or myocardial infarction at any point in the patient’s past medical history, as stated in the history and physical section of the medical record. Information on prior placement of a coronary stent or undergoing a coronary artery bypass graft surgery should support coding this comorbidity
b. Congestive heart failure. To score this clinical presentation, the medical record should have a statement about the development of symptoms/signs of congestive heart failure (e.g., an exertional or paroxysmal nocturnal dyspnea) that later responded to diuretics, afterload-reducing agents, β blocker, and/or digitalis at any time in the patient’s past medical history.
c. Low ejection fraction (EF). Patients with an EF of 50% or lower or a SF (for pediatric patients) of 26% or lower as determined by an echocardiogram or a multi-gated acquisition scan are assigned a score of 1. As noted before, evaluation of this comorbidity item should be restricted to the most recent measurements of EF or SF before the landmark date. Lack of evaluation of EF or SF for an individual patient before transplant does not preclude the calculation of a total HCT-CI score for that patient.
3. Inflammatory bowel disease (score 1). A score of 1 is assigned for this comorbidity on the basis of the presence of a documented prior diagnosis (history of an endoscopic examination of the mucosa with or without confirmatory histology and radiologic findings) of Crohn’s disease or ulcerative colitis requiring treatment at any time in the patient’s past medical history. If the patient has never received a treatment of this comorbidity, no score is assigned.
4. Diabetes (score 1). A score of 1 is assigned for this comorbidity on the basis of the diagnosis of diabetes or steroid-induced hyperglycemia requiring continuous treatment with insulin or oral hypoglycemic drugs during the instantaneous period of 4 weeks before the landmark date. No score is assigned for this comorbidity if diabetes could be controlled with diet alone or if a previous treatment of diabetes or steroid-induced hyperglycemia was stopped 4 weeks before the landmark date.
5. Cerebrovascular disease (score 1). A score of 1 is assigned for cerebrovascular disease on the basis of a prior diagnosis of transient ischemic attack, subarachnoid hemorrhage, or cerebral thrombosis, embolism, or hemorrhage at any time in the past medical history. No details on treatment are required for assigning a score for this comorbidity.
6. Psychiatric disorder (score 1). A score of 1 is assigned for this comorbidity on the basis of the presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the instantaneous period of 4 weeks before the landmark date. Depression and anxiety are the most common psychiatric disorders encountered in transplant populations, yet other disorders such as schizophrenia or bipolar disorder should also be coded for this comorbidity. Patients who are receiving only “as-needed” medications for any of the above disorders are not assigned a score for this comorbidity.
7. Hepatic comorbidity (2 levels of severity). As a general rule, assessment of the laboratory tests has to include at least 2 values per test on 2 different days within a period extending between Days −24 and −10 before HCT. That period could be extended to be between Days −40 and −10 only in the case that liver function tests were done only once between Days −24 and −10 before HCT. The laboratory value closest to the landmark date should be the value used in defining the severity of hepatic comorbidity. The upper limit of normal (ULN) for any of the 3 tests is determined on the basis of the reference range per the institution laboratory.
a. Mild hepatic comorbidity (score 1): A maximal score of 1 is assigned for mild hepatic comorbidity in the presence of 1 or more of the following 3 clinical presentations: (1) elevated total bilirubin to a value higher than the ULN and up to 1.5 times the ULN; (2) elevated values of any of the 2 hepatic transaminase enzymes, ALT or AST, to values higher than the ULN and up to 2.5 times the ULN; or (3) a prior diagnosis of an infection with hepatitis B or C at any time in the patient’s past medical history before the landmark date.
b. Moderate to severe hepatic comorbidity (score 3): A maximal score of 3 is assigned for moderate to severe hepatic comorbidity in the presence of 1 or more of the following 3 clinical presentations: (1) elevated values of total bilirubin to a level higher than 1.5 times the ULN; (2) elevated values of any or both of the 2 hepatic transaminase enzymes to levels higher than 2.5 times the ULN; or (3) a documented diagnosis of liver cirrhosis at any time in the patient’s past medical history before the landmark date.
8. Obesity (score 1). A score of 1 is assigned for obesity based on a body mass index (BMI) higher than 35.00 kg/m2 for patients older than 18 years or a BMI for age of the 95th percentile or higher for patients aged 18 years or younger. Evaluation of this comorbidity is based on the most recent measurement of the BMI (or weight and height needed for the calculation of the BMI) before the landmark date.
9. Infection (score 1). A maximal score of 1 is assigned for infection comorbidity in the presence of 1 or more of the following 4 clinical presentations: (1) a documented infection (eg, by culture or biopsy), (2) fever of unknown origin, (3) pulmonary nodules suspicious for fungal pneumonia, or (4) a positive purified protein derivative test requiring prophylaxis against tuberculosis. Patients must have started a specific antimicrobial treatment before the landmark date with a recommendation, documented in the chart either by the primary team or the infection consult team, to continue the same antimicrobial therapy (or a similar agent) during the days of administration of a conditioning regimen and beyond day 0 of HCT.
10. Rheumatologic comorbidity (score 2). A score of 2 is assigned for a rheumatic comorbidity on the basis of the presence of a documented prior diagnosis of a rheumatologic disease that has required administration of a specific treatment at any time in the patient’s past medical history. Diagnoses include systemic rheumatologic and connective tissue disorders such as systemic lupus erythematosus, rheumatoid arthritis, Sjögren’s syndrome, scleroderma, polymyositis, dermatomyositis, mixed connective tissues disease, polymyalgia rheumatica, polychondritis, sarcoidosis, and vasculitis syndromes. Patients with undiagnosed polyarthritis, degenerative joint disease, or osteoarthritis are not scored for this comorbidity. Occasionally, a patient might have a clinical pattern of a systemic rheumatologic disease responding to a specific treatment but without a definitive diagnosis. For example, I was consulted once on a patient with an unspecified collagen vascular disease that had presented 4 years earlier and had manifested by iritis, uveitis, bowel disturbances, and muscle aches. This unspecified collagen vascular disease responded to low-dose systemic steroids. Even though there was no definitive rheumatologic diagnosis in this case, I erred on the side of caution and assigned a score for this presentation as a rheumatologic comorbidity.
Patients with quiescent rheumatologic diseases who are receiving no treatment in the immediate period before the landmark date are assigned a score for this comorbidity if they have fulfilled the prior criteria.
11. Peptic ulcer (score 2). A score of 2 is assigned for peptic ulcer on the basis of the presence of a prior endoscopic or radiologic diagnosis of gastric or duodenal ulcer, noted in the medical record, at any point in the patient’s past medical history. Patients with quiescent peptic ulcer who are receiving no treatment in the immediate period before the landmark date are assigned a score for this comorbidity if they have met the prior criteria.
12. Renal comorbidity (score 2). A maximal score of 2 is assigned for renal comorbidity in the presence of 1 or more of the following 3 clinical presentations: (1) elevated values of serum creatinine to more than 2 mg/dL or more than 176.8 μmol/L as detected in at least 2 laboratory tests on 2 different days within a period extending between Days −24 and −10 before HCT (this evaluation period could be extended to span between Days −40 and −10 if serum creatinine was evaluated only once between Days −24 and −10 before HCT); (2) chronic renal disease requiring weekly dialysis within the instantaneous period of 4 weeks before the landmark date; or (3) a documented prior history of renal transplantation at any point in the patient’s past medical history..
13. Pulmonary comorbidity (2 levels of severity). As a general rule, assessment of pulmonary comorbidity for the purpose of assigning HCT-CI scores should exclusively rely on PFT results, and in particular corrected DLco and FEV1 percentages). A total HCT-CI score should not be calculated in the absence of data on PFT except in the case that PFT could not be done because of technical difficulties (e.g., in pediatric patients). Occasionally, patients are assessed by a postbronchodilator (reversibility) test. In this case, only the prebronchodilator values of FEV1 are considered for evaluation of pulmonary comorbidity.
Measured DLco values should first be corrected for the concurrent hemoglobin value using the Dinakara equation (corrected DLco = uncorrected DLco/ (0.06965 × hemoglobin g/dL)…. Then, the corrected value of measured DLco is divided by the predicted value to compute the percentage of DLco. Alternatively, the uncorrected DLco percentage, which is reported in all PFT reports, could be directly corrected for the concurrent hemoglobin value, using the Dinakara equation to compute the corrected DLco percentage. Either way will lead to the same final percentage of corrected DLco. The Dinakara equation is favored over other equations such as the one by Cotes et al… because of its more robust ability to account for the effects of anemia, a common sign of the primary hematologic disease, and because it is the equation used by the PFT laboratory at Fred Hutchinson Cancer Research Center, where the HCT-CI was originally developed.
a. Moderate pulmonary comorbidity (score 2). A maximal score of 2 is assigned for moderate pulmonary comorbidity in the presence of 1 or more of the following 3 clinical presentations: (1) a percentage of DLco in the range of 66% to 80% or (2) a percentage of FEV1 in the range of 66% to 80% (both should be the most recent measurements before the landmark date), or (3) shortness of breath on slight activity that is attributed to a pulmonary disease and cannot be corrected by blood transfusion for a noticeable anemia, as assessed during a clinic visit within the immediate period of 2 weeks before the landmark date.
b. Severe pulmonary comorbidity (score 3). A maximal score of 3 is assigned for severe pulmonary comorbidity in the presence of 1 or more of the following 4 clinical presentations: (1) a percentage of DLco of 65% or less or (2) a percentage of FEV1 of 65% or less (both should be the most recent measurements before the landmark date); (3) shortness of breath at rest that is attributed to a pulmonary disease and cannot be corrected by blood transfusion for a noticeable anemia, as assessed during a clinic visit within the immediate period of 2 weeks before the landmark date; or (4) the need for intermittent or continuous oxygen supplementation during the immediate period of 4 weeks before the landmark date.
14. Prior malignancy (score 3). A score of 3 is assigned for this comorbidity on the basis of the presence of a prior diagnosis of any malignancy that required receiving a specific treatment at any point in the patient’s past medical history, regardless of the type of treatment (surgery, radiotherapy, and/or drug therapy). Lymphomas or myelomas that preceded the diagnosis of a myeloid malignancy (e.g., acute myeloid leukemia, myelodysplastic syndromes, or chronic myeloid leukemia) are assigned a score for this comorbidity. Similarly, myeloid malignancies that preceded the diagnosis of lymphomas or myelomas are assigned a score for this comorbidity.
Patients with a prior malignancy from the same lineage of cells of the current malignancy should not be assigned a score for this comorbidity; for example, if a patient had a diagnosis of non-Hodgkin lymphoma that was preceded by Hodgkin lymphoma or if a patient had a diagnosis of AML that was preceded by myelodysplastic syndromes.
Melanoma, but not basal or squamous cell carcinoma of the skin, should be assigned a score for this comorbidity. Patients with a prior malignancy that never required a specific treatment are not scored for this comorbidity. Tumors of a benign nature are not scored for this comorbidity.
15. Heart valve disease (score 3). A maximal score of 3 is assigned for heart valve comorbidity in the presence of 1 or more of the following 3 clinical presentations: (1) at least a moderate or severe degree of valve stenosis or insufficiency, as determined by echocardiogram, whether that valve was mitral, aortic, tricuspid, or pulmonary; (2) prosthetic mitral or aortic valve; or (3) symptomatic mitral valve prolapse. Assessment of this comorbidity is limited to the most recent heart evaluation by echocardiogram before the landmark date.
CCG v1.0 | CRF v1.3
Post your comment on this topic.