| Title |
An Automated System Combining Safety Signal Detection and Prioritization from Healthcare Databases: A Pilot Study
|
|---|---|
| Published in |
Drug Safety, November 2017
|
| DOI | 10.1007/s40264-017-0618-y |
| Pubmed ID | |
| Authors |
Mickael Arnaud, Bernard Bégaud, Frantz Thiessard, Quentin Jarrion, Julien Bezin, Antoine Pariente, Francesco Salvo |
| Abstract |
Signal detection from healthcare databases is possible, but is not yet used for routine surveillance of drug safety. One challenge is to develop methods for selecting signals that should be assessed with priority. The aim of this study was to develop an automated system combining safety signal detection and prioritization from healthcare databases and applicable to drugs used in chronic diseases. Patients present in the French EGB healthcare database for at least 1 year between 2005 and 2015 were considered. Noninsulin glucose-lowering drugs (NIGLDs) were selected as a case study, and hospitalization data were used to select important medical events (IME). Signal detection was performed quarterly from 2008 to 2015 using sequence symmetry analysis. NIGLD/IME associations were screened if one or more exposed case was identified in the quarter, and three or more exposed cases were identified in the population at the date of screening. Detected signals were prioritized using the Longitudinal-SNIP (L-SNIP) algorithm based on strength (S), novelty (N), and potential impact of signal (I), and pattern of drug use (P). Signals scored in the top 10% were identified as of high priority. A reference set was built based on NIGLD summaries of product characteristics (SPCs) to compute the performance of the developed system. A total of 815 associations were screened and 241 (29.6%) were detected as signals; among these, 58 (24.1%) were prioritized. The performance for signal detection was sensitivity = 47%; specificity = 80%; positive predictive value (PPV) 33%; negative predictive value = 82%. The use of the L-SNIP algorithm increased the early identification of positive controls, restricted to those mentioned in the SPCs after 2008: PPV = 100% versus PPV = 14% with its non-use. The system revealed a strong new signal with dipeptidylpeptidase-4 inhibitors and venous thromboembolism. The developed system seems promising for the routine use of healthcare data for safety surveillance of drugs used in chronic diseases. |
X Demographics
The data shown below were collected from the profiles of 4 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| France | 4 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 4 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 43 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 43 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Ph. D. Student | 9 | 21% |
| Other | 5 | 12% |
| Student > Master | 5 | 12% |
| Researcher | 5 | 12% |
| Student > Bachelor | 5 | 12% |
| Other | 6 | 14% |
| Unknown | 8 | 19% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 8 | 19% |
| Pharmacology, Toxicology and Pharmaceutical Science | 7 | 16% |
| Nursing and Health Professions | 5 | 12% |
| Computer Science | 4 | 9% |
| Mathematics | 2 | 5% |
| Other | 5 | 12% |
| Unknown | 12 | 28% |
Attention Score in Context
This research output has an Altmetric Attention Score of 3. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 23 December 2017.
All research outputs
#12,764,378
of 23,009,818 outputs
Outputs from Drug Safety
#1,176
of 1,704 outputs
Outputs of similar age
#195,457
of 438,547 outputs
Outputs of similar age from Drug Safety
#11
of 21 outputs
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