An Event‐Based Approach for Comparing the Performance of Methods for Prospective Medical Product Monitoring

Prospective medical product monitoring is intended to alert stakeholders about whether and when safety problems are identifiable in longitudinal electronic healthcare data. Little attention has been given to how to compare methods in this setting.

[1]  A. M. Walker,et al.  Precautions for proactive surveillance , 2002, Pharmacoepidemiology and drug safety.

[2]  Michael E Matheny,et al.  Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices. , 2010, JAMA.

[3]  W. Youden,et al.  Index for rating diagnostic tests , 1950, Cancer.

[4]  Sebastian Schneeweiss,et al.  A basic study design for expedited safety signal evaluation based on electronic healthcare data , 2010, Pharmacoepidemiology and drug safety.

[5]  Alexander Dekhtyar,et al.  Information Retrieval , 2018, Lecture Notes in Computer Science.

[6]  M. Schuemie,et al.  Combining electronic healthcare databases in Europe to allow for large‐scale drug safety monitoring: the EU‐ADR Project , 2011, Pharmacoepidemiology and drug safety.

[7]  T. Hedner,et al.  Angio-oedema in relation to treatment with angiotensin converting enzyme inhibitors. , 1992, BMJ.

[8]  B. Psaty,et al.  Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions: Use of Cerivastatin and Risk of Rhabdomyolysis , 2004 .

[9]  Alexander M Walker,et al.  Signal detection for vaccine side effects that have not been specified in advance , 2010, Pharmacoepidemiology and drug safety.

[10]  B. Matthews Comparison of the predicted and observed secondary structure of T4 phage lysozyme. , 1975, Biochimica et biophysica acta.

[11]  Martijn J Schuemie,et al.  Methods for drug safety signal detection in longitudinal observational databases: LGPS and LEOPARD , 2011, Pharmacoepidemiology and drug safety.

[12]  Sebastian Schneeweiss,et al.  Managing drug-risk information--what to do with all those new numbers. , 2009, The New England journal of medicine.

[13]  M. Kulldorff,et al.  A Maximized Sequential Probability Ratio Test for Drug and Vaccine Safety Surveillance , 2011 .

[14]  P. Bossuyt,et al.  The diagnostic odds ratio: a single indicator of test performance. , 2003, Journal of clinical epidemiology.