MTN-003 Training
Rounding and Lab Results
Recording Lab Values and
Assigning Severity Grade Ranges
1
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
2
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
3
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
4
Recording Lab Values
• Lab-reported values may have
more digits than the CRF
• If so, round up or down before
recording on the CRF
5
Example
Hemoglobin = 11.06 g/dL
The following appears on CRF:
.
g/dL
Round up and record as:
1
6
1 . 1
g/dL
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
7
Example
Creatinine = 128 μmol/L
The following appears on CRF:
.
mg/dL
128 μmol/L ÷ 88.4 = 1.448 mg/dL
Round down and record as:
0
8
1 . 4
mg/dL
Recording Lab Values
• Lab-reported values may also have
fewer digits than the CRF
• If so, record missing digits as “0” on
the CRF
9
Example
Hematocrit = 42%
The following appears on CRF:
.
%
Fill in “0” for missing digit:
4
10
2 . 0
%
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
11
Example: Total Bilirubin
Tox Table
Grade 1
=
1.1–1.5 x ULN
ULN
=
1.3 mg/dL
Calculated
Grade 1
=
12
(1.1 x ULN)–(1.5 x ULN)
=
(1.1 x 1.3)–(1.5 x 1.3)
=
1.43–1.95 mg/dL
Example: Total Bilirubin, cont.
Calculated
Grade 1
=
1.43–1.95 mg/dL
Lab value
=
1.4 mg/dL
=
1.40 mg/dL
1.40
<
1.43
Lab value
Grade 1 min
Decision: Do not assign a severity grade
13
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)
14
Example: Total Bilirubin
ULN
Calculated
Grade 1
Calculated
Grade 2
Lab value
=
1.3 mg/dL
=
1.43–1.95 mg/dL
=
=
2.08–3.25 mg/dL
2.0 mg/dL = 2.00 mg/dL
1.95
<
2.00
<
2.08
Grade 1 max Lab value Grade 2 min
Decision: Report as Grade 2
15
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)
16
Questions?
17