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Use of EVDAS for monitoring purposes
Piotr Nowicki, MDWarsaw, 06-Oct-2011
Presentation Content
• Job Definition• Challenges• Use of the EVDAS system• Further Questions / Solution Proposal• Outlook / Further Development• Points to Consider• Q&A
Piotr Nowicki, MD pnow@pragmalog.com 2
Job Definition
• The scope of work is to monitor the SDRs (signals of disproportionate reporting) over time
• The monitoring reports are sent every month
• There are about 20 products to be monitored
• The report format provided: pdf – files
Piotr Nowicki, MD pnow@pragmalog.com 3
PDF Report Sample - Header
Piotr Nowicki, MD pnow@pragmalog.com 4
PDF Report Sample – Marked SDRs
Piotr Nowicki, MD pnow@pragmalog.com 5
Initial Feasibility Calculations All SDR SDR %
ALBENDAZOLE 2010-03-28 399 28 7,02
AMINOLEVULINIC ACID 2010-03-28 21 0 0,00
BICALUTAMIDE 2010-03-28 775 18 2,32
FINASTERIDE 2010-03-28 1033 67 6,49
FLUTICASONE 2010-03-28 654 31 4,74
HUMAN THROMBIN, HUMAN CLOTTABLE PROTEIN CONTAINING MAINLY FIBRINOGEN AND FIBRONECTIN 2010-03-28
9 2 22,22
HYOSCINE 2010-03-28 232 19 8,19
LOPERAMIDE 2010-03-28 363 13 3,58
METAMIZOLE 2010-03-28 480 23 4,79
METRONIDAZOLE 2010-03-28 1266 47 3,71
MONTELUKAST 2010-03-28 1083 35 3,23
NITRENDIPINE 2010-03-28 269 6 2,23
OLANZAPINE 2010-03-28 2870 163 5,68
OMEPRAZOLE 2010-03-28 1882 43 2,28
ORLISTAT 2010-03-28 1455 64 4,40
PERINDOPRIL 2010-03-28 349 22 6,30
RISEDRONATE SODIUM 2010-03-28 1944 199 10,24
RISPERIDONE 2010-03-28 2537 113 4,45
RIVASTIGMINE 2010-03-28 1282 63 4,91
ROSUVASTATIN 2010-03-28 1427 41 2,87
THIAMAZOLE 2010-03-28 618 28 4,53
Total 20948 1025 4,89
Piotr Nowicki, MD pnow@pragmalog.com 6
Challenges
• The pdf reports provided have to be reviewed manually
• The numbers of drug-events combinations is relatively high - approx. 20000 a month ; number of SDRs approx. 1000 (~5%)
• The drug – event combinations are provided cumulatively
Piotr Nowicki, MD pnow@pragmalog.com 7
Challenges Cont.
• Emerging Issues:
– How to get more information - case details?
– How to see trends ?
– How to track the data (i.e. see the differences over time for the drug-events pairs of interest) ?
– How to document the decisions taken ?
Piotr Nowicki, MD pnow@pragmalog.com 8
Performing Data Analysis with EVDAS
• Variety of Online Reports
• SDR over time charts
• Drill down possibilities (from SDR to Case level)
Piotr Nowicki, MD pnow@pragmalog.com 9
Reaction Monitoring Report
Piotr Nowicki, MD pnow@pragmalog.com 10
Case List
Piotr Nowicki, MD pnow@pragmalog.com 11
Case Details
Piotr Nowicki, MD pnow@pragmalog.com 12
Dynamic PRR Report – SDR over Time
Piotr Nowicki, MD pnow@pragmalog.com 13
PRR Monitor report displaying the PRR Confidence Intervals
Piotr Nowicki, MD pnow@pragmalog.com 14
PRR Monitor (CHI^2) report Bold lines represent the thresholds of PRR =2 and chi^2 = 4
Piotr Nowicki, MD pnow@pragmalog.com 15
Further Questions/Solution Proposal
• Outstanding questions
– How to monitor the data for each pdf report provided every month? – partially solved with EVDAS
– How to document the decisions taken and track them over time?
Piotr Nowicki, MD pnow@pragmalog.com 16
Reaction Monitoring Report (simple format export)
Piotr Nowicki, MD pnow@pragmalog.com 17
Reaction Monitoring Report Export(drill down with additional counts)
Piotr Nowicki, MD pnow@pragmalog.com 18
Conversion of the files (Extract data from the header and create columns: Product name, Retrieval
date, Remove number separators etc.)
Piotr Nowicki, MD pnow@pragmalog.com 19
Imported Data
Piotr Nowicki, MD pnow@pragmalog.com 20
Filtered view of the imported data
Piotr Nowicki, MD pnow@pragmalog.com 21
Monitoring Charts
Piotr Nowicki, MD pnow@pragmalog.com 22
Monitoring Charts with assessment fields
Piotr Nowicki, MD pnow@pragmalog.com 23
Outlook / Further development
• Add case details – import of cases needed• Additional charts:
– Monitor the changes in the „process”• Common sense approach definition of rules
– Effective use of available Product data:– SPC and Mapping Algorithms (further issues to be
solved e.g. coding)
Piotr Nowicki, MD pnow@pragmalog.com 24
Process in Control?
Piotr Nowicki, MD pnow@pragmalog.com 25
Common sense approach - Rules
Piotr Nowicki, MD pnow@pragmalog.com 26
Points to Consider
• Support from EVDAS?• Reports in text file format e.g. (CSV)• Files with case list but with different/additional columns?• Full case details in another format ?• Better performance to be expected?
•Other solutions?
Piotr Nowicki, MD pnow@pragmalog.com 27
Q & A
Piotr Nowicki, MD pnow@pragmalog.com 28
Piotr Nowicki, MD pnow@pragmalog.com 29
Overview
Piotr Nowicki, MD pnow@pragmalog.com 30
Overview
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