1. How to clean up dirty data in Patient reported outcomes?
14 May 2019
How to clean up dirty data in Patient reported outcomes?
Knut Mueller
Senior Statistical Programmer
UCB Monheim
14 May 2019

2. Regulatory Aspects / Guidelines / Rules Approach Process Description
Introduction
Regulatory Aspects / Guidelines / Rules
Approach
Process Description
Summary and Conclusions
14 May 2019

3. Introduction Patient Reported Outcomes Unclean Data Traceability
Keep valuable information
14 May 2019

4. Guidelines and Rules
FDA Guidance for Industry – Patient-Reported Outcome Measures
Counting Rules set up by Health Outcomes department
No on-site transcription of ambiguous data
track and report original answers of the subject
14 May 2019

5. Approach standard macro OC Database PRO SDTM datasets ADaM datasets
TFLs
Data Entry
Stat Prog
Stat Prog
Stat Prog DM
standard macro
14 May 2019

6. Approach Development of a validated Standard macro
can be used similar to CALL routine
number of paramters <6
Identification, invar, outvar, values, most severe value, tracking variable
User friendliness
14 May 2019

7. Process description - overview
STEP 1
missing values?
YES
STEP 2 NO
correct values?
YES NO
STEP 3B
STEP 3A
more than one "correct" answer?
adjacent multiple answers?
take most severe
YES
YES NO
STEP 4
correct answer + our of range answer?
remove out of range value
YES NO
STEP 5
correct answer + comment?
remove comment
YES NO
Missing value
correct value
14 May 2019

8. Process description – step 1
Missing value or missing code? NA ND UN
IF YES  missing value . . . .
IF NO  GO TO STEP 2
14 May 2019

9. Process description – step 2
Correct value?
"2"
"3"
"1"
"4"
IF YES  take this value 2 3 1 4
IF NO  GO TO STEP 3A
14 May 2019

10. Process description – step 3A
multiple answer, all answers inside the range, no more than maximum?
"2/3"
"3/5"
"1/2"
"1/4"
IF YES  GO TO STEP 3B
IF NO  GO TO STEP 4
14 May 2019

11. Process description – step 3B
All values adjacent ?
"2/3"
"3/5"
"1/2"
"1/4"
IF YES  take the most severe value 2 1
IF NO  missing value . .
14 May 2019

12. Process description – step 4
Correct value plus out of range answer?
"2/6"
"5/7"
"0/1"
"5/6"
IF YES  remove the out of range value 2 5 1 5
IF NO  GO TO STEP 5
14 May 2019

13. Process description – step 5
Correct value plus comment?
"2?"
"5++"
"+/-1"
"3/4/5"
IF YES  remove the comment 2 5 1
IF NO  missing value .
14 May 2019

14. Caveats All decisions have to be carefully tracked and checked
especially step 5 handles cases that aren't as closely defined than the others
unexpected cases
14 May 2019

15. e PROs What about e PROs? need to be validated
technical equipment necessary
probably the solution for the future
14 May 2019

16. Conclusions Compliance with FDA Guidance
use of validated standard macro saves programming time
the CALL routine approach still provides a considerable amount of control over the process
Necessity of close quality checks
14 May 2019