Q81 – 86: Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

Question 81: What scale was used to determine the recipient’s functional status?

The CIBMTR uses the Karnofsky / Lansky scale to determine the functional status of the recipient immediately prior to the start of the preparative regimen. The Karnofsky Scale is designed for recipients aged 16 years and older and is not appropriate for children under the age of 16. The Lansky Scale is designed for recipients one year old to less than 16 years old.

If the recipient is less than one year old, leave the Performance score questions blank.

Questions 82 – 83: Performance score prior to the start of the preparative regimen

Recipient performance status is a critical data field that has been determined to be essential for all outcome-based studies. The CIBMTR uses the Karnofsky / Lansky scale to determine the functional status of the recipient immediately prior to the start of the preparative regimen. For the purposes of this manual, the term “immediately prior” represents the pre-HCT work-up phase, or approximately one month prior to the start of the preparative regimen. In cases where the pre-transplant work-up occurs in months prior to transplant (i.e., the pre-transplant workup occurs more than one month prior to transplant), a documented performance score may be submitted if the recipient does not have a score closer to the start of the preparative regimen, the recipient receives no additional treatment after the date of assessment, and the recipient’s status does not clearly decline.

Select the appropriate performance scale, Karnofsky or Lansky, based on the recipient’s age. Using this scale, select the score (10-100) that best represents the recipient’s activity status immediately prior to the start of the preparative regimen. For an example of the Karnofsky / Lansky scale, see Appendix L.

If a Karnofsky / Lansky score is not documented in the source documentation (e.g., inpatient progress note, physician’s clinic note), data management professionals should not assign a performance score based on analysis of available documents. Rather, a physician or mid-level health care provider (NPs and PAs) should provide documentation of the performance score. Documentation from an RN who has been trained and authorized to determine performance scores may also be used.

The CIBMTR recognizes that some transplant centers prefer to collect and use the ECOG performance score as opposed to the Karnofsky / Lansky score. Although the ECOG and Karnofsky / Lansky performance score systems are based on similar principles, the scales are not the same. For example, the Karnofsky / Lansky scale is described in 11 categories, whereas the ECOG performance status is reported in six categories. Due to the overlap between the two systems, an ECOG score of “one” can represent either “80” or “90” on the Karnofsky/Lansky scale. For centers that collect only an ECOG performance score, CIBMTR will make the following accommodations when auditing the source data:

• Centers collecting ECOG scores should do so using standard practices to ensure accuracy.
• For the purposes of CIBMTR reporting, conversion of ECOG to Karnofsky / Lansky should follow a standard and consistent practice. This practice should be clear and reproducible.
  

For more information regarding converting an EGOG score to a Karnofsky / Lansky score, see Appendix L.

Question 84: Specify blood type (of recipient): (For allogeneic HCTs only)

Indicate the recipient’s blood type as A, B, AB, or O. Blood type is an important characteristic in allogeneic transplant because products may require manipulation to minimize the risk of immune reaction due to incompatibility.

Question 85: Specify Rh factor (of recipient): (For allogeneic HCTs only)

Indicate the recipient’s Rh (rhesus) factor. The Rh factor is an important characteristic in allogeneic transplant because products may require manipulation to minimize the risk of immune reaction due to incompatibility.

Question 86: Recipient CMV-antibodies (IgG or Total)

Report the cytomegalovirus (CMV) status of the recipient immediately prior to the start of the preparative regimen. For the purposes of this manual, the term “immediately prior” represents the pre-HCT work-up phase, or approximately one month prior to the start of the preparative regimen. An exception to this definition would apply to a recipient with a documented history of a “reactive” CMV test result. In this case, the CMV test may not be repeated during the pre-HCT work-up phase. Therefore, a timeframe of greater than one month prior to the start of the preparative regimen is acceptable. In cases where the pre-transplant work-up occurs in months prior to transplant (i.e., the pre-transplant workup occurs more than one month prior to transplant), a CMV assessment may be submitted if the recipient does not have an assessment closer to the start of the preparative regimen.

CMV is a common virus that infects 50-80% of adults worldwide and is transmitted from person to person through bodily fluids. The virus that causes CMV is part of the herpes virus family and, like other herpes viruses, CMV may be dormant for a period of time before the virus is activated in the host. CMV infections are usually harmless in a healthy immune system and typically cause only mild symptoms, if any. However, if a person’s immune system is seriously weakened (as in an immunosuppressed stem cell recipient) the virus can have serious consequences such as pneumonia, liver failure, and even death.

Most laboratory reports indicate a positive result as reactive, and a negative result as non-reactive. Occasionally, laboratory reports show a specific antibody titer. In this case, compare the laboratory result to the reported standards to determine if the result was reactive or non-reactive.

If the laboratory reports a CMV IgM antibody only, not total IgG/IgM or CMV IgG antibody, report the result as Not done.

If the laboratory reports the results as “inconclusive” or “equivocal,” select Indeterminant.

Indicate the test result documented on the laboratory report as either Reactive, Non-reactive, Indeterminant, or Not done.

Additional Considerations:

• Recipients < 6 months: If the recipient is less than 6 months old, report any positive CMV antibody results as “not done” due to the presence of maternal antibodies. However, in infants greater than 6 months old, positive CMV PCR results indicate a CMV infection and the results may be reported as “reactive.”
• Exposure to IVIG: Exposure to IVIG may result in a false positive CMV antibody result. If the recipient has been exposed to IVIG leading up to HCT (within 3-6 months), indicate the CMV antibody results using the following guidelines:
  • If the recipient had a non-reactive CMV antibody result prior to IVIG therapy and then routine CMV PCR results showed no copies of CMV, the CMV antibody may be reported as “non-reactive,” even if the CMV antibody became reactive during IVIG treatment.
  • If CMV PCR results quantified copies of CMV DNA (i.e., was positive) during IVIG treatment, the results may be reported as “reactive.”
  • If the recipient did not have a CMV antibody test prior to the initiation of IVIG, but had a positive antibody test during the IVIG therapy, report “not done.”
  • “Not done” should be reported if no CMV antibody tests were done prior to the initiation of IVIG therapy, even if CMV PCR testing was negative during IVIG treatment (because CMV PCR only detects active infection, not prior exposure).
• Documented history of “reactive” CMV: In cases where a recipient has a documented history of a “reactive” CMV test and does not have a history of IVIG or blood transfusions from a CMV positive donor, “reactive” should be reported for the CMV status even if the CMV test is repeated during the pre-HCT work-up phase and is “non-reactive”.
• CMV testing by PCR: If the laboratory reports CMV testing by PCR (DNA detection) but no CMV antibody testing is done during the pre-transplant work-up or within one month prior to transplant, report the result as “not done.” CMV testing by PCR is used to detect the presence of the CMV virus and does not test for prior exposure.
  

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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