VigiSearch/VigiMine. Magnus Wallberg. November 24 th 2009 Dar Es Salaam, Tanzania.
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1 VigiSearch/VigiMine Magnus Wallberg November 24 th 2009 Dar Es Salaam, Tanzania
2 First a short reminder
3 WHO database MedDRA E2b Intdis Eudravigilance Home-built tools National Centre National Centre VigiFlow
4 Drug dictionary In VigiBase all drugs/vaccines on reports are mapped against the WHO Drug Dictionary (WHO-DD) All drugs in WHO-DD contain information about active ingredients and ATC codes Enables analysis based on active ingredients or ATC codes Removes complexity of different names on medicinal products containing the same active ingredient when analyzing data But still allows for comparisons between products
5 Terminologies All ADR terms in VigiBase are mapped against a MedDRA and WHO-ART Analysis can be made using both terminologies Releases the strength of both terminologies WHO-ART smaller, may simplify analysis MedDRA use of Standardized MedDRA Queries (SMQs) Indications, background diseases and so forth are coded against ICD or MedDRA Since WHO-ART is used by the African countries the focus in this presentation will be on WHO-ART
6 VigiSearch
7 WHO database MedDRA E2b Intdis Eudravigilance Home-built tools National Centre National Centre VigiFlow
8 VigiSearch Search interface for Vigibase data Web based Freely available for all members in the WHO Program for International Drug Monitoring Actually combination of two tools: VigiSearch VigiMine, included in VigiSearch in November 2008
9 Modules included in VigiSearch Query interface with predefined filters Reporting statistics substances and ADRs Line listing Single report output Saved queries and results
10 VigiMine Produces IC values for reaction/substance pairs according to the BCPNN algorithm BCPNN Bayesian Confidence Propagation Neural Network IC Information component Produces statistics with IC values stratified by: Sex Age group Capable of producing time scans How the IC values changes over time
11 IC? Information Component A value describing the deviation from the normal distribution of an ADR/substance combination. The mathematical model behind the IC value is complex here is a very simplified explanation
12 IC simplified example Assume that you have: reports ADR terms A 1 But 000 Drugs as mentioned B Then The it probability is not for as reaction easy A as is 1/1000 this (1 ) in The probability for Drug B is also 1/1000 (1 ) reality due to the nature of drugs There should statistically be one combination of ADR A and drug ADRs, B confidence intervals etc If so the IC will have a value of 0 If there are more than one combination, the IC will have a value above 0 A signal is indicated if the IC value is over 1
13 VigiSearch/VigiMine structure Main page Help VigiSearch query form VigiMine query form Statistics Simple list Details Report list Report (PDF)
14 The VigiSearch track
15 Building a query in VigiSearch To find what you are looking for in VigiSearch you have the following search possibilities Product name, substance or ATC-code Reaction (SOC, HLT, PT or IT level) Gender Age group Route Country Date Causality
16 Query form
17
18 Running a query The query will be queued as running and marked as executed when finished this allows for the running of large (time consuming) queries
19 Running a query
20 Getting the result
21 Retrieving the reports
22 Single ICSR output format
23 The VigiMine track
24 Query form/combination list The VigiMine query form is built using the same concept as VigiSearch but with different filters The drug and reaction selections are the same There is no expanded query view The result on the active filters are displayed immediately as a list of combinations Therefore when entering the query form the combinations with highest IC values in the entire database are displayed
25
26 Details/statistics
27 Simple report list
28 VigiSearch/VigiMine recall Main page Help VigiSearch query form VigiMine query form Statistics Simple list Details Report list Report (PDF)
29
30 More about terminologies In VigiSearch and VigiMine you can search on WHO-ART or MedDRA * and look at listings and reports in any of those so which one should you pick? * MedDRA is the default
31 Lets take a look at the MedDRA grouping structure again Report1 Report2 WA1 M1 WHO-ART view 2 reports 1 term WA2 WA3 M2 M3 M4 M5 M6 MedDRA view 2 reports 2 terms WA4 M7 WA5 M8
32 VigiSearch live demonstration
33 WHO Collaborating Centre for International Drug Monitoring Box 1051, SE Uppsala Sweden Tel , Fax info@who-umc.org Website:
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