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Guidelines for Rounding Lab Results and Assigning Severity Grades

This guide provides instructions on how to round lab values and assign severity grades accurately. Follow these rounding rules: only consider the digit immediately to the right of your desired place, rounding up if it's 5 or greater, and down if it's less. Ensure to record lab values correctly on the Case Report Form (CRF), adjusting for significant digits as needed. When assigning severity grades based on lab results, always refer to the established toxicity tables and remember that rounding is only for recorded lab values, never during grade calculation steps.

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Guidelines for Rounding Lab Results and Assigning Severity Grades

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  1. MTN-003 TrainingRounding and Lab Results Recording Lab Values and Assigning Severity Grade Ranges

  2. How to Round • Round using only the digit immediately to the right of the desired place • Round up if greater than or equal to 5 • e.g., 1.55 = 1.6 • Round down if less than or equal to 4 • e.g., 1.54 = 1.5

  3. Example Round 1.4479638 to the tenths place • DO consider only the digit to the right of the tenths place • DO, based on the value of this digit (4), round down to 1.4 1.4479638 = 1.4

  4. Example, cont. Round 1.4479638 to the tenths place • DON’T consider digits beyond the digit next to the tenths place • DON’T, based on the value of these digits, round up to 1.45 and then round again to 1.5 1.4479638 ≠ 1.5

  5. Recording Lab Values • Lab-reported values may have more digits than the CRF • If so, round up or down before recording on the CRF

  6. g/dL . 1 1 1 g/dL . Example Hemoglobin = 11.06 g/dL The following appears on CRF: Round up and record as:

  7. If Unit Conversion is Required • Converted result may have more digits than the CRF • If so, round up or down before recording on the CRF

  8. mg/dL . 0 1 4 mg/dL . Example Creatinine = 128 μmol/L The following appears on CRF: 128 μmol/L ÷ 88.4 = 1.448 mg/dL Round down and record as:

  9. Recording Lab Values • Lab-reported values may also have fewer digits than the CRF • If so, record missing digits as “0” on the CRF

  10. % . 4 2 0 % . Example Hematocrit = 42% The following appears on CRF: Fill in “0” for missing digit:

  11. Assigning Severity Grades • Compare lab value to toxicity table • Toxicity table may require you to calculate a grade range based on site lab normals • e.g., Grade 1 = 1.1–1.5 x site ULN • Calculated grade range may have more digits than lab value • If so, treat “missing” lab value digits as zero

  12. Example: Total Bilirubin Tox TableGrade 1 = 1.1–1.5 x ULN ULN = 1.3 mg/dL Calculated Grade 1 = (1.1 x ULN)–(1.5 x ULN) = (1.1 x 1.3)–(1.5 x 1.3) = 1.43–1.95 mg/dL

  13. 1.40 < 1.43Lab valueGrade 1 min Example: Total Bilirubin, cont. Calculated Grade 1 = 1.43–1.95 mg/dL Lab value = 1.4 mg/dL = 1.40 mg/dL Decision: Do not assign a severity grade

  14. Assigning Severity Grades • Lab value may fall between two calculated severity grades • If so, assign the higher grade • According to DAIDS Toxicity Table general instructions (page 1)

  15. 1.95 < 2.00 < 2.08 Grade 1 max Lab value Grade 2 min Example:Total Bilirubin ULN = 1.3 mg/dL Calculated Grade 1 = 1.43–1.95 mg/dL Calculated Grade 2 = 2.08–3.25 mg/dL Lab value = 2.0 mg/dL = 2.00 mg/dL Decision: Report as Grade 2

  16. Remember • Rounding is allowed only when recording a lab value on a CRF • When calculating a severity grade range, never round on interim steps • Always compare the severity grade range to the value recorded on the CRF (not the lab-reported value)

  17. Questions?

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