Mini-Sentinel methods: Framework for assessment of positive results from signal refinement

Pharmacoepidemiology and Drug Safety

Volumn 23, Issue 1, 2014, Pages 3-8

  Mcclure, David L ^a   Raebel, Marsha A ^b,c   Yih, W Katherine ^d   Shoaibi, Azadeh ^e   Mullersman, Jerald E ^e,f   Anderson Smits, Colin ^g   Glanz, Jason M ^b,h  

^a MARSHFIELD CLINIC   (United States)

^b KAISER PERMANENTE   (United States)

^c UNIVERSITY OF COLORADO   (United States)

^d HARVARD MEDICAL SCHOOL   (United States)

^e CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^f East Tennessee State University   (United States)

^g CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^h Food Science and Human Nutrition   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMPUTER PROGRAM; CONCEPTUAL FRAMEWORK; DATA MINING; DRUG EXPOSURE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HEALTH CARE QUALITY; HEALTH PROGRAM; HUMAN; MEDICAL DEVICE; MINI SENTINEL PROGRAM; NOTE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROBABILITY; QUANTITATIVE ANALYSIS; STATISTICS; SYSTEMATIC ERROR; VALIDITY;

HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; SELECTION BIAS; SENTINEL SURVEILLANCE; STATISTICS AS TOPIC;

EID: 84891626003     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3547     Document Type: Note

References (24)

1. Robb MA, Racoosin JA, Sherman RE, et al. The US Food and Drug Administration's Sentinel Initiative: expanding the horizons of medical product safety. Pharmacoepidemiol Drug Saf 2012 Jan; 21(Suppl 1): 9-11.
2. Platt R, Carnahan RM, Brown JS, et al. The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf 2012 Jan; 21(Suppl 1): 1-8.
3. Baggs J, Gee J, Lewis E, et al. The Vaccine Safety Datalink: a model for monitoring immunization safety. Pediatrics 2011 May; 127(Suppl 1): S45-53.
4. Yih WK, Kulldorff M, Fireman BH, et al. Active surveillance for adverse events: the experience of the Vaccine Safety Datalink Project. Pediatrics 2011; 127(Suppl 1): S54-64.
5. Kulldorff M. Sequential statistical methods for prospective post-marketing safety surveillance. In Pharmacoepidemiology (5th edn), Strom BL, Kimmel SE, Hennessy S (eds.). Wiley: Sussex, England, 2011.
6. Kessler DA. Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problems. JAMA 1993 Jun 2; 269(21): 2765-2768.
7. Ahmad SR. Adverse Drug Event Monitoring at the Food and Drug Administration. J Gen Intern Med 2003; 18: 57-60.
8. Marinac-Dabic D, Normand SL, Sedrakyan A, Gross T. Epidemiologic studies of medical devices: methodologic considerations for implantable devices. In Pharmacoepidemiology (5th edn), Strom BL, Kimmel SE, Hennessy S (eds.). Wiley: Sussex, England, 2011.
9. Porta M editor. Confounding by indication. A Dictionary of Epidemiology (5th edn). Oxford University Press: New York, 2008.
10. Li L, Kulldorff M. A conditional maximized sequential probability ratio test for pharmacovigilance. Stat Med 2010 Jan 30; 29(2): 284-95.
11. Strom BL. Overview of automated databases in pharmacoepidemiology. In Pharmacoepidemiology (5th edn), Strom BL, Kimmel SE, Hennessy S (eds.). Wiley: Sussex, England, 2011; pp. 158-162.
12. Naus J, Wallenstein S. Temporal surveillance using scan statistics. Stat Med 2006; 25(2): 311-324.
13. McClure DL, Xu S, Weintraub E, Glanz JM. An efficient statistical algorithm for a temporal scan statistic applied to vaccine safety analyses. Vaccine 2012 Jun 8; 30(27): 3986-3991.
14. Lash TL, Fox MP, Fink AK. Applying Quantitative Bias Analysis to Epidemiologic Data. Springer: New York, 2009.
15. Greenland S, Lash TL. Bias Analysis. In Modern Epidemiology (3rd edn), Rothman KJ, Greenland S, Lash TL (eds.). Lippincott Williams and Wilkins: Philadelphia, 2008; 345-380.
16. Poole C. Low P-values or narrow confidence intervals: which are more durable? Epidemiol 2001 May; 12(3): 291-294.
17. Lash TL, Fox MP, Fink AK. Simple bias analysis. In Applying Quantitative Bias Analysis to Epidemiologic Data. Springer: New York, 2009; pp. 27-28.
18. Lash TL, Fox MP, Fink AK. Multidimensional bias analysis. In Applying Quantitative Bias Analysis to Epidemiologic Data. Springer: New York, 2009; pp. 28-29.
19. Lash TL, Fox MP, Fink AK. Probabilistic bias analysis. In Applying Quantitative Bias Analysis to Epidemiologic Data. Springer: New York, 2009; pp. 29-30.
20. Lash T, Fink AK. Semi-automated sensitivity analysis to assess systematic errors in observational data. Epidemiology 2003; 14: 451-458.
21. Fox MP, Lash TL, Greenland S. A method to automate probabilistic sensitivity analyses of misclassified binary variables. Int J Epidemiol 2005; 34: 1370-1376.
22. Lash TL, Schmidt M, Jensen AØ, Engebjerg MC. Methods to apply probabilistic bias analysis to summary estimates of association. Pharmacoepidemiol Drug Saf. 2010 Jun; 19(6): 638-644.
23. Lash TL, Fox MP, Fink AK. Multiple biases modeling. In Applying Quantitative Bias Analysis to Epidemiologic Data. Springer: New York, 2009; pp. 30-31.
24. Greenland S. Multiple bias modeling for analysis of observational data. J R Stat Soc A 2005; 168: 1-25.