Question 103: What scale was used to determine the recipient’s functional status prior to the cellular therapy? (check all that apply)
Select all that apply the scale that was used to determine the recipient’s functional status prior to the cellular therapy: Karnofsky, Lanksy, and/or ECOG. For CAR-T recipients, both KPS and ECOG are often documented. In this case, report both scores.
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 104-105: Performance score prior to the cellular therapy
Recipient performance status is a critical data field that has been determined to be essential for all outcome-based studies. CIBMTR uses the Karnofsky / Lansky scale to determine the functional status of the recipient immediately prior to the start of the lymphodepleting therapy. For the purposes of this manual, the term “immediately prior” represents the pre-infusion work-up phase, or approximately one month prior to the start of the lympho-depleting therapy. In cases where the pre-infusion work-up occurs in months prior to infusion (i.e., the pre-infusion workup occurs more than one month prior to infusion), a documented performance score may be submitted if the recipient does not have a score closer to the start of the lymphodepleting therapy, 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, based on the recipient’s age. Using this scale, select the score (10 – 100) as documented by the clinician 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: Karnofsky / Lansky Performance Status.
If a Karnofsky / Lansky score is not documented in the source documentation (i.e., 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.
Question 106: ECOG score
Recipient performance status is a critical data field that has been determined to be essential for all outcome- based studies. ECOG is typically documented for CAR-T recipients, along with KPS, immediately prior to the start of the lymphodepleting therapy. For the purposes of this manual, the term “immediately prior” represents the pre-infusion work-up phase, or approximately one month prior to the start of the lympho-depleting therapy. In cases where the pre-infusion work-up occurs in months prior to infusion (i.e., the pre-infusion workup occurs more than one month prior to infusion), a documented performance score may be submitted if the recipient does not have a score closer to the start of the lymphodepleting therapy, , the recipient receives no additional treatment after the date of assessment, and the recipient’s status does not clearly decline.
If a performance 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 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.
Section Updates:
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