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Text Mining the MAUDE Database
1.
Signal Detection of Adverse
Medical Device Events in the FDA MAUDE Database Eric Brinsfield, MS Presenter & Research Collaborator David Olaleye, MSCE, PhD Author & Primary Research Statistician SAS Institute Inc. Cary, NC Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
2.
Disclosure Statement Both
presenters are employees of SAS Institute We have no conflicts of interest Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenters and should not be attributed to ISPE or to SAS Institute. 2 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
3.
Study Objectives Determine if
text mining can be used to: Detect signals of adverse events in spontaneous reporting data Better understand or triage signals generated by traditional disproportionality methods Phase 1: Evaluate unsupervised text mining Using FDA MAUDE database Focused on stents 3 Company Confidential - For Internal Use Only 3 Copyright © 2010, SAS Institute Inc. All rights reserved.
4.
Definitions Safety Signal
“A report or reports of an event with an unknown causal relationship to treatment that is recognized as worthy of further exploration and continued surveillance.” » Council for International Organizations of Medical Sciences (CIOMS) “Recognition” is often the results of Analytical or automatic signal detection methods that look for unexpected patterns in data sources such as: » Spontaneously reported data » Observational healthcare data » Insurance claims data 4 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
5.
Methods Data Source
= MAUDE FDA Spontaneous Reporting System Database for Med. Devices MAUDE - Manufacturer and User Facility Device Experience Contains the narrative entered by the reporter Target Devices endovascular graft system and coronary stent devices devices classified as a stent in the “product_category_code”: » MAF, MIH, NIN, NIO, NIP, NIM, and NIQ » http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classif ication.cfm?ID=896 5 Company Confidential - For Internal Use Only 5 Copyright © 2010, SAS Institute Inc. All rights reserved.
6.
MAUDE (2001-2008) Spontaneous “safety”
reports on medical devices Strengths: Only surveillance system which covers devices marketed in the entire US Largest number of case reports on adverse outcomes and malfunctions for medical devices Provides opportunity to detect signals of new, rare and unusual adverse clinical outcomes » Usually warrants further investigation Includes narrative description of events » Better than AERS which does not include narrative 6 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
7.
Characteristics of Spontaneous
Report Suitable for hypotheses generation; not for confirmation or rates computation Exhibit under-reporting and other reporting biases; lack of control group, etc. Data quality, ascertainment, accuracy and completeness of information are usually poor Includes events and incidents not causally related to medical device exposure Does not distinguish between label versus off-label uses of approved products Contains minimal or no patient history and other potential causal factors Do not provide estimates of exposure (worse in drugs) 7 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
8.
Study Design: Case-Series
Source Population All MAUDE reports received between 2006 – 2010 (N=35954) Study Device Cohort Study Events MAUDE reports for stents • Death (D) with product codes: • Injury (I) MAF, MIH, NIN, NIO, • Malfunctions (M) NIP, NIM, and NIQ • Other (O) Device-Adverse Outcomes Pairs (N=28) 8 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
9.
Analysis Steps 1. Attempt
analysis using text mining alone Ignore device Evaluate if general text mining provides any insights 2. Perform standard disproportionality analysis on structured data PRR, EBGM, Adj. Residual 3. Identify device-AE pairs that have: High scores Especially in the “Other” classification 4. Investigate the device with text mining Include all outcome classifications 9 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
10.
Text Mining Process
Parse terms to create documents-terms frequency matrix Use singular value decomposition (SVD) to measure association and perform hierarchical clustering Use entropy method to cluster SVDs for documents classification 10 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
11.
Sample Narrative -
Injury Example of Manufacturer Report - Injury the product labeling for a p154 states that this product is indicated for use in pts with obstruction of major biliary ducts. the product labeling also states that the stent may be increased post-placement by expanding with a larger diameter balloon. the following was obtained through conversation with the user facility on 1/15/98. after deciding that a ptca procedure in a renal artery did not yield adequate results, the md attempted to place a medium biliary stent in the artery. the physician reported to co. that he had difficulty visualizing the stent and that it was difficult to place. he deployed the stent, but was not satisfied with the outcome. in response, he decided to place a second stent inside of the first. however, the stents interlocked and the physician decided to remove both stents, he was able to withdraw the stent up to sheath tip in the femoral artery, but needed a vascular surgeon to completely remove them. info regarding the type of removal procedure has not been provided to co. the physician further stated that he believes that the first stent had not fully opened. it was mounted on a meditech glidex balloon. 11 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
12.
Concept Linking and
Exploration 12 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
13.
Text mining clusters
over all reports 13 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
14.
Text Mining Over
All Reports Results are interesting But inconclusive Lose track of the device But may detect new trends for all stent devices in study Cannot really do comparisons due to lack of denominator. (Same problems as always with spontaneous reports.) Next, run disproportionality to narrow the focus… 14 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
15.
Disproportionality Results for
Carotid Stent (NIM) Adjusted MGPS Adverse Event Freq Residual (EBGM) Death 276 0.8 0.86728 Injury 2043 1.1 1.130264 Malfuntion 271 0.4 0.424803 Other 24 1.6 3.648191 * Adjusted Residual: Flagged at values over 1.5 EBGM: Flagged at values over 2.0 15 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
16.
Target for Text
Mining Evaluation NIM showed high proportion of “Other” Based on relative percentage of reports Based on signal scoring algorithms All methods suggested a flag Although only 24 cases, the method could show promise Run text mining against all NIM reports Include all outcomes to fully understand reports Look for possible explanations or hypotheses 16 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
17.
N Text Mining Clusters
for NIM +percutaneous +unk dissection performance +unstable repaired 376 +malfunction 'device remains implanted' reactions collapsing +'premature deployment' cracks +'product quality 41 issue' replaced performance collapsed malfunction fractures +fracture +'inaccurate delivery' fractured 846 malfunctions drift +'premature deployment' +normal dissection +unk 'no information' +na collapsing unk fractured 69 'device issue' broke 'no known device problem' +break broken +'shaft 227 break' reaction reactions abnormal +fracture +continuous +bent cracks unk +break fractured 65 filter +na 'difficult to advance' breaks reaction +bent +malfunction 150 replaced 'device remains implanted' collapsed 'no flow' performance +crack 44 +break +collapse filter fractured repair +crack breaks +collapse +'product quality issue' 'no 31 flow' reaction 17 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
18.
18
Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
19.
Manual Review of
Text for “Other” Most were not adverse events that persisted Some seemed like “FYI” reports. Two included notification of a formal study Most patients still had the stent in place (assumed) Some cases of installation problems: Potential installer error Most did not involve an adverse event 19 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
20.
Conclusion Text mining
shows promise for recognizing primary words and patterns Hard to form hypotheses from bulk text mining on spontaneous database Combination with disproportionality analysis creates signals that can be further analyzed with text mining Terms in the “Other” category overlap with other categories 20 Company Confidential - For Internal Use Only 20 Copyright © 2010, SAS Institute Inc. All rights reserved.
21.
Next Steps Need further
analysis that includes: Large target group for further triage “Other” was too small in this case Preferred term matching and encoding To clean up fuzziness and reduce clusters Content categorization Look for more structure and combine with ontologies Sentiment analysis Determine if overall sentiment was good or bad 21 Company Confidential - For Internal Use Only 21 Copyright © 2010, SAS Institute Inc. All rights reserved.
22.
Final Thoughts “What the
future portends is more and more information — Everests of it. There won’t be anything we won’t know. But there will be no one thinking about it.” From: New York Times - August 13, 2011 The Elusive Big Idea By NEAL GABLER Neal Gabler is a senior fellow at the Annenberg Norman Lear Center at the University of Southern California and the author of “Walt Disney: The Triumph of the American Imagination.” We need to help make time for thinking. 22 Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
23.
Thank You Contacts: Eric
Brinsfield eric.brinsfield@sas.com David Olaleye david.olaleye@sas.com Company Confidential - For Internal Use Only Copyright © 2010, SAS Institute Inc. All rights reserved.
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