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Volumn 16, Issue 6, 2017, Pages 721-732

Methods for safety signal detection in healthcare databases: a literature review

Author keywords

data mining; Drug safety; pharmacoepidemiology; pharmacovigilance; signal detection

Indexed keywords

CASE CONTROL STUDY; DATA MINING; HUMAN; PHARMACOEPIDEMIOLOGY; REVIEW; SAFETY; SIGNAL DETECTION; COMPARATIVE STUDY; DRUG SURVEILLANCE PROGRAM; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FACTUAL DATABASE; MACHINE LEARNING; PROCEDURES; STATISTICS AND NUMERICAL DATA;

EID: 85019841639     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1080/14740338.2017.1325463     Document Type: Review
Times cited : (63)

References (82)
  • 1
    • 84886735430 scopus 로고    scopus 로고
    • The past, present and perhaps future of pharmacovigilance: homage to Folke Sjoqvist
    • Moore N., The past, present and perhaps future of pharmacovigilance:homage to Folke Sjoqvist. Eur J Clin Pharmacol. 2013;69(S1):33–41.• A well-documented review presenting the history and future of safety signal detection.
    • (2013) Eur J Clin Pharmacol , vol.69 , Issue.S1 , pp. 33-41
    • Moore, N.1
  • 2
    • 77953568356 scopus 로고    scopus 로고
    • A decade of data mining and still counting
    • Hauben M, Norén GN. A decade of data mining and still counting. Drug Saf. 2010;33(7):527–534.
    • (2010) Drug Saf , vol.33 , Issue.7 , pp. 527-534
    • Hauben, M.1    Norén, G.N.2
  • 3
    • 34447520376 scopus 로고    scopus 로고
    • Novel statistical tools for monitoring the safety of marketed drugs
    • Almenoff JS, Pattishall EN, Gibbs TG, et al. Novel statistical tools for monitoring the safety of marketed drugs. Clin Pharmacol Ther. 2007;82(2):157–166.
    • (2007) Clin Pharmacol Ther , vol.82 , Issue.2 , pp. 157-166
    • Almenoff, J.S.1    Pattishall, E.N.2    Gibbs, T.G.3
  • 4
    • 0028072358 scopus 로고
    • False-positives in spontaneous reporting: should we worry about them?
    • Bégaud B, Moride Y, Tubert-Bitter P, et al. False-positives in spontaneous reporting:should we worry about them? Br J Clin Pharmacol. 1994;38(5):401–404.
    • (1994) Br J Clin Pharmacol , vol.38 , Issue.5 , pp. 401-404
    • Bégaud, B.1    Moride, Y.2    Tubert-Bitter, P.3
  • 5
    • 33751071330 scopus 로고    scopus 로고
    • The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France
    • Olivier P, Montastruc J-L. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France. Pharmacoepidemiol Drug Saf. 2006;15(11):808–812.
    • (2006) Pharmacoepidemiol Drug Saf , vol.15 , Issue.11 , pp. 808-812
    • Olivier, P.1    Montastruc, J.-L.2
  • 6
    • 84870699940 scopus 로고    scopus 로고
    • Is spontaneous reporting always the most important information supporting drug withdrawals for pharmacovigilance reasons in France?
    • Paludetto M-N, Olivier-Abbal P, Montastruc J-L. Is spontaneous reporting always the most important information supporting drug withdrawals for pharmacovigilance reasons in France? Pharmacoepidemiol Drug Saf. 2012;21(12):1289–1294.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.12 , pp. 1289-1294
    • Paludetto, M.-N.1    Olivier-Abbal, P.2    Montastruc, J.-L.3
  • 7
    • 0037009914 scopus 로고    scopus 로고
    • Rates of spontaneous reporting of adverse drug reactions in France
    • Bégaud B, Martin K, Haramburu F, et al. Rates of spontaneous reporting of adverse drug reactions in France. Jama. 2002;288(13):1588.
    • (2002) Jama , vol.288 , Issue.13 , pp. 1588
    • Bégaud, B.1    Martin, K.2    Haramburu, F.3
  • 8
    • 0031052834 scopus 로고    scopus 로고
    • Under-reporting of adverse drug reactions in general practice
    • Moride Y, Haramburu F, Requejo AA, et al. Under-reporting of adverse drug reactions in general practice. Br J Clin Pharmacol. 1997;43(2):177–181.
    • (1997) Br J Clin Pharmacol , vol.43 , Issue.2 , pp. 177-181
    • Moride, Y.1    Haramburu, F.2    Requejo, A.A.3
  • 9
    • 34748847390 scopus 로고    scopus 로고
    • Impact of safety alerts on measures of disproportionality in spontaneous reporting databases the notoriety bias
    • Pariente A, Gregoire F, Fourrier-Reglat A, et al. Impact of safety alerts on measures of disproportionality in spontaneous reporting databases the notoriety bias. Drug Saf. 2007;30(10):891–898.
    • (2007) Drug Saf , vol.30 , Issue.10 , pp. 891-898
    • Pariente, A.1    Gregoire, F.2    Fourrier-Reglat, A.3
  • 10
    • 2942554869 scopus 로고    scopus 로고
    • Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration
    • Hartnell NR, Wilson JP. Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration. Pharmacother J Hum Pharmacol Drug Ther. 2004;24(6):743–749.
    • (2004) Pharmacother J Hum Pharmacol Drug Ther , vol.24 , Issue.6 , pp. 743-749
    • Hartnell, N.R.1    Wilson, J.P.2
  • 11
    • 77951780214 scopus 로고    scopus 로고
    • Meta-analysis: proton pump inhibitor use and the risk of community-acquired pneumonia
    • Mar
    • Johnstone J, Nerenberg K, Loeb M. Meta-analysis:proton pump inhibitor use and the risk of community-acquired pneumonia. Aliment Pharmacol Ther. 2010 Mar 4;31(11):1165–1177.
    • (2010) Aliment Pharmacol Ther , vol.31 , Issue.11 , pp. 1165-1177
    • Johnstone, J.1    Nerenberg, K.2    Loeb, M.3
  • 12
    • 84934943578 scopus 로고    scopus 로고
    • Risk of community-acquired pneumonia with outpatient proton-pump inhibitor therapy: a systematic review and meta-analysis
    • Lambert AA, Lam JO, Paik JJ, et al. Risk of community-acquired pneumonia with outpatient proton-pump inhibitor therapy:a systematic review and meta-analysis. Plos One. 2015;10(6):e0128004.
    • (2015) Plos One , vol.10 , Issue.6 , pp. e0128004
    • Lambert, A.A.1    Lam, J.O.2    Paik, J.J.3
  • 13
    • 33646818280 scopus 로고    scopus 로고
    • Evaluating drug effects in the post-vioxx world: there must be a better way
    • Avorn J. Evaluating drug effects in the post-vioxx world:there must be a better way. Circulation. 2006;113(18):2173–2176.
    • (2006) Circulation , vol.113 , Issue.18 , pp. 2173-2176
    • Avorn, J.1
  • 14
    • 6044267892 scopus 로고    scopus 로고
    • Failing the public health—rofecoxib, Merck, and the FDA
    • Topol EJ. Failing the public health—rofecoxib, Merck, and the FDA. N Engl J Med. 2004;351(17):1707–1709.
    • (2004) N Engl J Med , vol.351 , Issue.17 , pp. 1707-1709
    • Topol, E.J.1
  • 15
    • 9644302576 scopus 로고    scopus 로고
    • Postmarketing surveillance—lack of vigilance, lack of trust
    • Fontanarosa PB. Postmarketing surveillance—lack of vigilance, lack of trust. Jama. 2004;292(21):2647.
    • (2004) Jama , vol.292 , Issue.21 , pp. 2647
    • Fontanarosa, P.B.1
  • 16
    • 85006969593 scopus 로고    scopus 로고
    • A method for the minimization of competition bias in signal detection from spontaneous reporting databases
    • Arnaud M, Salvo F, Ahmed I, et al. A method for the minimization of competition bias in signal detection from spontaneous reporting databases. Drug Saf. 2016;39(3):251–260.
    • (2016) Drug Saf , vol.39 , Issue.3 , pp. 251-260
    • Arnaud, M.1    Salvo, F.2    Ahmed, I.3
  • 17
    • 85019899247 scopus 로고    scopus 로고
    • Class-imbalanced subsampling lasso algorithm for discovering adverse drug reactions
    • published online, april
    • Ahmed I, Pariente A, Tubert-Bitter P. Class-imbalanced subsampling lasso algorithm for discovering adverse drug reactions. Stat Methods Med Res. 2016. 25april 2016. published online. DOI:10.1177/0962280216643116.
    • (2016) Stat Methods Med Res
    • Ahmed, I.1    Pariente, A.2    Tubert-Bitter, P.3
  • 18
    • 84884982179 scopus 로고    scopus 로고
    • Outlier removal to uncover patterns in adverse drug reaction surveillance - a simple unmasking strategy
    • Juhlin K, Ye X, Star K, et al. Outlier removal to uncover patterns in adverse drug reaction surveillance - a simple unmasking strategy. Pharmacoepidemiol Drug Saf. 2013;22(10):1119–1129.
    • (2013) Pharmacoepidemiol Drug Saf , vol.22 , Issue.10 , pp. 1119-1129
    • Juhlin, K.1    Ye, X.2    Star, K.3
  • 19
    • 84892858902 scopus 로고    scopus 로고
    • A conceptual approach to the masking effect of measures of disproportionality
    • Maignen F, Hauben M, Hung E, et al. A conceptual approach to the masking effect of measures of disproportionality. Pharmacoepidemiol Drug Saf. 2014;23(2):208–217.
    • (2014) Pharmacoepidemiol Drug Saf , vol.23 , Issue.2 , pp. 208-217
    • Maignen, F.1    Hauben, M.2    Hung, E.3
  • 20
    • 18044398603 scopus 로고    scopus 로고
    • A review of uses of health care utilization databases for epidemiologic research on therapeutics
    • Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol. 2005;58(4):323–337.
    • (2005) J Clin Epidemiol , vol.58 , Issue.4 , pp. 323-337
    • Schneeweiss, S.1    Avorn, J.2
  • 21
    • 79959764260 scopus 로고    scopus 로고
    • Safety surveillance of longitudinal databases: methodological considerations
    • Norén GN, Hopstadius J, Bate A, et al. Safety surveillance of longitudinal databases:methodological considerations. Pharmacoepidemiol Drug Saf. 2011;20(7):714–717.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , Issue.7 , pp. 714-717
    • Norén, G.N.1    Hopstadius, J.2    Bate, A.3
  • 23
    • 84960105180 scopus 로고    scopus 로고
    • Good signal detection practices: evidence from IMI PROTECT
    • Wisniewski AFZ, Bate A, Bousquet C, et al. Good signal detection practices:evidence from IMI PROTECT. Drug Saf. 2016;39(6):469–490.
    • (2016) Drug Saf , vol.39 , Issue.6 , pp. 469-490
    • Wisniewski, A.F.Z.1    Bate, A.2    Bousquet, C.3
  • 24
    • 84862932391 scopus 로고    scopus 로고
    • The U.S. food and drug administration’s mini-sentinel program: status and direction
    • 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;21:1–8.• A clear presentation of the objectives and the challenges existing when attempting to set up a post-market drug safety framework using the information available on observational health-care databases.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , pp. 1-8
    • Platt, R.1    Carnahan, R.M.2    Brown, J.S.3
  • 25
    • 84930465921 scopus 로고    scopus 로고
    • , December
    • U.S. Food and Drug Administration. Mini-Sentinel. 2014. Available at:http://www.mini-sentinel.org [Last accessed 13December 2016]
    • (2014) Mini-Sentinel
  • 26
    • 78751688048 scopus 로고    scopus 로고
    • Advancing the science for active surveillance: rationale and design for the observational medical outcomes partnership
    • Stang PE, Ryan PB, Racoosin JA, et al. Advancing the science for active surveillance:rationale and design for the observational medical outcomes partnership. Ann Intern Med. 2010;153(9):600–606.
    • (2010) Ann Intern Med , vol.153 , Issue.9 , pp. 600-606
    • Stang, P.E.1    Ryan, P.B.2    Racoosin, J.A.3
  • 27
    • 85019863175 scopus 로고    scopus 로고
    • , Last accessed, December
    • Observational medical outcomes partnership. Available at:http://omop.org [Last accessed 13 December 2016]
    • (2016)
  • 28
    • 84880046381 scopus 로고    scopus 로고
    • The asian pharmacoepidemiology network (AsPEN): promoting multi-national collaboration for pharmacoepidemiologic research in Asia
    • AsPEN collaborators, Andersen M, Bergman U, Choi N-K, et al. The asian pharmacoepidemiology network (AsPEN):promoting multi-national collaboration for pharmacoepidemiologic research in Asia. Pharmacoepidemiol Drug Saf 2013;22(7):700–704.
    • (2013) Pharmacoepidemiol Drug Saf , vol.22 , Issue.7 , pp. 700-704
    • Andersen, M.1    Bergman, U.2    Choi, N.-K.3
  • 29
    • 85019965486 scopus 로고    scopus 로고
    • , Last accessed, December
    • Asian pharmacoepidemiological network. Available at:http://aspennet.asia/index.html [Last accessed 13 December 2016]
    • (2016)
  • 30
    • 84874500562 scopus 로고    scopus 로고
    • Disproportionality methods for pharmacovigilance in longitudinal observational databases
    • Zorych I, Madigan D, Ryan P, et al. Disproportionality methods for pharmacovigilance in longitudinal observational databases. Stat Methods Med Res. 2013;22(1):39–56.• Study presenting the different ways to apply the disproportionality methods on observational health-care databases.
    • (2013) Stat Methods Med Res , vol.22 , Issue.1 , pp. 39-56
    • Zorych, I.1    Madigan, D.2    Ryan, P.3
  • 31
    • 84866563491 scopus 로고    scopus 로고
    • Using electronic health care records for drug safety signal detection: a comparative evaluation of statistical methods
    • Schuemie MJ, Coloma PM, Straatman H, et al. Using electronic health care records for drug safety signal detection:a comparative evaluation of statistical methods. Med Care. 2012;50(10):890–897.
    • (2012) Med Care , vol.50 , Issue.10 , pp. 890-897
    • Schuemie, M.J.1    Coloma, P.M.2    Straatman, H.3
  • 32
    • 84892930594 scopus 로고    scopus 로고
    • Empirical performance of a new user cohort method: lessons for developing a risk identification and analysis system
    • Ryan PB, Schuemie MJ, Gruber S, et al. Empirical performance of a new user cohort method:lessons for developing a risk identification and analysis system. Drug Saf. 2013;36(S1):59–72.
    • (2013) Drug Saf , vol.36 , Issue.S1 , pp. 59-72
    • Ryan, P.B.1    Schuemie, M.J.2    Gruber, S.3
  • 33
    • 84892947582 scopus 로고    scopus 로고
    • Empirical performance of the case–control method: lessons for developing a risk identification and analysis system
    • Madigan D, Schuemie MJ, Ryan PB. Empirical performance of the case–control method:lessons for developing a risk identification and analysis system. Drug Saf. 2013;36(S1):73–82.
    • (2013) Drug Saf , vol.36 , Issue.S1 , pp. 73-82
    • Madigan, D.1    Schuemie, M.J.2    Ryan, P.B.3
  • 34
    • 84892930407 scopus 로고    scopus 로고
    • Empirical performance of the self-controlled case series design: lessons for developing a risk identification and analysis system
    • Suchard MA, Zorych I, Simpson SE, et al. Empirical performance of the self-controlled case series design:lessons for developing a risk identification and analysis system. Drug Saf. 2013;36(S1):83–93.
    • (2013) Drug Saf , vol.36 , Issue.S1 , pp. 83-93
    • Suchard, M.A.1    Zorych, I.2    Simpson, S.E.3
  • 35
    • 85019946845 scopus 로고    scopus 로고
    • , December
    • Murphy SN, Castro V, Colecchi J, et al. Partners healthcare OMOP study report. 2011. Available at:http://omop.org. [Last accessed 13December 2016].•• Study presenting the first OMOP experiment that implemented, tested, and compared numerous methods:disproportionality analysis, traditional, pharmacoepidemiological designs, TPD, and sequential statistical testing.
    • (2011) Partners healthcare OMOP study report
    • Murphy, S.N.1    Castro, V.2    Colecchi, J.3
  • 36
    • 84892945980 scopus 로고    scopus 로고
    • Empirical performance of a self-controlled cohort method: lessons for developing a risk identification and analysis system
    • Ryan PB, Schuemie MJ, Madigan D. Empirical performance of a self-controlled cohort method:lessons for developing a risk identification and analysis system. Drug Saf. 2013;36(S1):95–106.
    • (2013) Drug Saf , vol.36 , Issue.S1 , pp. 95-106
    • Ryan, P.B.1    Schuemie, M.J.2    Madigan, D.3
  • 37
    • 0029821351 scopus 로고    scopus 로고
    • Evidence of depression provoked by cardiovascular medication: a prescription sequence symmetry analysis
    • Hallas J. Evidence of depression provoked by cardiovascular medication:a prescription sequence symmetry analysis. Epidemiology. 1996;7(5):478–484.• Study conceptualizing the SSA method for signal detection.
    • (1996) Epidemiology , vol.7 , Issue.5 , pp. 478-484
    • Hallas, J.1
  • 38
    • 37349104178 scopus 로고    scopus 로고
    • Early detection of adverse drug events within population-based health networks: application of sequential testing methods
    • Brown JS, Kulldorff M, Chan KA, et al. Early detection of adverse drug events within population-based health networks:application of sequential testing methods. Pharmacoepidemiol Drug Saf. 2007;16(12):1275–1284.
    • (2007) Pharmacoepidemiol Drug Saf , vol.16 , Issue.12 , pp. 1275-1284
    • Brown, J.S.1    Kulldorff, M.2    Chan, K.A.3
  • 39
    • 78751631255 scopus 로고    scopus 로고
    • A maximized sequential probability ratio test for drug and vaccine safety surveillance
    • Kulldorff M, Davis RL, Kolczak† M, et al. A maximized sequential probability ratio test for drug and vaccine safety surveillance. Seq Anal. 2011;30(1):58–78.
    • (2011) Seq Anal , vol.30 , Issue.1 , pp. 58-78
    • Kulldorff, M.1    Davis, R.L.2    Kolczak, M.3
  • 40
    • 70449411797 scopus 로고    scopus 로고
    • A conditional sequential sampling procedure for drug safety surveillance
    • Li L. A conditional sequential sampling procedure for drug safety surveillance. Stat Med. 2009;28(25):3124–3138.
    • (2009) Stat Med , vol.28 , Issue.25 , pp. 3124-3138
    • Li, L.1
  • 41
    • 33745797724 scopus 로고    scopus 로고
    • Mining unexpected associations for signalling potential adverse drug reactions from administrative health databases
    • Ng W-K, Kitsuregawa M, Li J, Chang K, editors
    • Jin H, Chen J, Kelman C, et al. Mining unexpected associations for signalling potential adverse drug reactions from administrative health databases. Adv Knowl Discov Data Min. 2006;3918:867–876. Ng W-K, Kitsuregawa M, Li J, Chang K, editors.
    • (2006) Adv Knowl Discov Data Min , vol.3918 , pp. 867-876
    • Jin, H.1    Chen, J.2    Kelman, C.3
  • 42
    • 77951765455 scopus 로고    scopus 로고
    • Signaling potential adverse drug reactions from administrative health databases
    • Jin H, Chen J, He H, et al. Signaling potential adverse drug reactions from administrative health databases. IEEE Trans Knowl Data Eng. 2010;22(6):839–853.
    • (2010) IEEE Trans Knowl Data Eng , vol.22 , Issue.6 , pp. 839-853
    • Jin, H.1    Chen, J.2    He, H.3
  • 43
    • 81355127388 scopus 로고    scopus 로고
    • Temporal pattern discovery in longitudinal electronic patient records
    • Norén GN, Hopstadius J, Bate A, et al. Temporal pattern discovery in longitudinal electronic patient records. Data Min Knowl Discov. 2010;20(3):361–387.
    • (2010) Data Min Knowl Discov , vol.20 , Issue.3 , pp. 361-387
    • Norén, G.N.1    Hopstadius, J.2    Bate, A.3
  • 44
    • 34447552427 scopus 로고    scopus 로고
    • A fuzzy logic-based computational recognition-primed decision model
    • Ji Y, Massanari RM, Ager J, et al. A fuzzy logic-based computational recognition-primed decision model. Inf Sci. 2007;177(20):4338–4353.• Study presenting an unusual approach based on a TAR algorithm combined with fuzzy logic.
    • (2007) Inf Sci , vol.177 , Issue.20 , pp. 4338-4353
    • Ji, Y.1    Massanari, R.M.2    Ager, J.3
  • 45
    • 84896067928 scopus 로고    scopus 로고
    • Signalling paediatric side effects using an ensemble of simple study designs
    • Reps JM, Garibaldi JM, Aickelin U, et al. Signalling paediatric side effects using an ensemble of simple study designs. Drug Saf. 2014;37(3):163–170.
    • (2014) Drug Saf , vol.37 , Issue.3 , pp. 163-170
    • Reps, J.M.1    Garibaldi, J.M.2    Aickelin, U.3
  • 46
    • 84938571741 scopus 로고    scopus 로고
    • A supervised adverse drug reaction signalling framework imitating Bradford Hill’s causality considerations
    • Reps JM, Garibaldi JM, Aickelin U, et al. A supervised adverse drug reaction signalling framework imitating Bradford Hill’s causality considerations. J Biomed Inform. 2015;56:356–368.•• Study presenting an interesting supervised machine-learning approach incorporating Bradford-Hill’s criteria.
    • (2015) J Biomed Inform , vol.56 , pp. 356-368
    • Reps, J.M.1    Garibaldi, J.M.2    Aickelin, U.3
  • 47
    • 84877619276 scopus 로고    scopus 로고
    • Drug safety data mining with a tree-based scan statistic
    • Kulldorff M, Dashevsky I, Avery TR, et al. Drug safety data mining with a tree-based scan statistic. Pharmacoepidemiol Drug Saf. 2013;22(5):517–523.• Study presenting an original approach for discovering ADRs based on hierarchical trees:the tree-based scan statistic method.
    • (2013) Pharmacoepidemiol Drug Saf , vol.22 , Issue.5 , pp. 517-523
    • Kulldorff, M.1    Dashevsky, I.2    Avery, T.R.3
  • 48
    • 0038931405 scopus 로고    scopus 로고
    • Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system
    • Aug
    • Dumouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat. 1999 Aug;53(3):177–190.
    • (1999) Am Stat , vol.53 , Issue.3 , pp. 177-190
    • Dumouchel, W.1
  • 49
    • 0031871338 scopus 로고    scopus 로고
    • A Bayesian neural network method for adverse drug reaction signal generation
    • Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol. 1998;54(4):315–321.
    • (1998) Eur J Clin Pharmacol , vol.54 , Issue.4 , pp. 315-321
    • Bate, A.1    Lindquist, M.2    Edwards, I.R.3
  • 50
    • 0030665406 scopus 로고    scopus 로고
    • Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs: a case/non-case study in the French pharmacovigilance system database
    • Nov
    • Moore N, Kreft-Jais C, Haramburu F, et al. Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs:a case/non-case study in the French pharmacovigilance system database. Br J Clin Pharmacol. 1997 Nov;44(5):513–518.
    • (1997) Br J Clin Pharmacol , vol.44 , Issue.5 , pp. 513-518
    • Moore, N.1    Kreft-Jais, C.2    Haramburu, F.3
  • 51
    • 0035700740 scopus 로고    scopus 로고
    • Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
    • Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10(6):483–486.
    • (2001) Pharmacoepidemiol Drug Saf , vol.10 , Issue.6 , pp. 483-486
    • Evans, S.J.W.1    Waller, P.C.2    Davis, S.3
  • 52
    • 50949096623 scopus 로고    scopus 로고
    • Adaptation of bayesian data mining algorithms to longitudinal claims data: coxib safety as an example
    • Curtis JR, Cheng H, Delzell E, et al. Adaptation of bayesian data mining algorithms to longitudinal claims data:coxib safety as an example. Med Care. 2008;46(9):969–975.
    • (2008) Med Care , vol.46 , Issue.9 , pp. 969-975
    • Curtis, J.R.1    Cheng, H.2    Delzell, E.3
  • 53
    • 77649227661 scopus 로고    scopus 로고
    • Signal detection of rosuvastatin compared to other statins: data-mining study using national health insurance claims database
    • Choi N-K, Chang Y, Choi YK, et al. Signal detection of rosuvastatin compared to other statins:data-mining study using national health insurance claims database. Pharmacoepidemiol Drug Saf. 2010;19(3):238–246.
    • (2010) Pharmacoepidemiol Drug Saf , vol.19 , Issue.3 , pp. 238-246
    • Choi, N.-K.1    Chang, Y.2    Choi, Y.K.3
  • 54
    • 82055172257 scopus 로고    scopus 로고
    • Comparison and validation of data-mining indices for signal detection: using the Korean national health insurance claims database
    • Choi N-K, Chang Y, Kim J-Y, et al. Comparison and validation of data-mining indices for signal detection:using the Korean national health insurance claims database. Pharmacoepidemiol Drug Saf. 2011;20(12):1278–1286.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , Issue.12 , pp. 1278-1286
    • Choi, N.-K.1    Chang, Y.2    Kim, J.-Y.3
  • 55
    • 80053612042 scopus 로고    scopus 로고
    • Signal detection of methylphenidate by comparing a spontaneous reporting database with a claims database
    • Kim J, Kim M, Ha J-H, et al. Signal detection of methylphenidate by comparing a spontaneous reporting database with a claims database. Regul Toxicol Pharmacol. 2011;61(2):154–160.
    • (2011) Regul Toxicol Pharmacol , vol.61 , Issue.2 , pp. 154-160
    • Kim, J.1    Kim, M.2    Ha, J.-H.3
  • 56
    • 79951975416 scopus 로고    scopus 로고
    • Methods for drug safety signal detection in longitudinal observational databases: LGPS and LEOPARD
    • Schuemie MJ. Methods for drug safety signal detection in longitudinal observational databases:LGPS and LEOPARD. Pharmacoepidemiol Drug Saf. 2011;20(3):292–299.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , Issue.3 , pp. 292-299
    • Schuemie, M.J.1
  • 57
    • 84892948635 scopus 로고    scopus 로고
    • A comparison of the empirical performance of methods for a risk identification system
    • Ryan PB, Stang PE, Overhage JM, et al. A comparison of the empirical performance of methods for a risk identification system. Drug Saf. 2013;36:(S1):143–58.•• Study presenting the second OMOP experiment, which improved the methodology for implementing and assessing the methods.
    • (2013) Drug Saf , vol.36
    • Ryan, P.B.1    Stang, P.E.2    Overhage, J.M.3
  • 58
    • 84892916187 scopus 로고    scopus 로고
    • Evaluating performance of risk identification methods through a large-scale simulation of observational data
    • Ryan PB, Schuemie MJ. Evaluating performance of risk identification methods through a large-scale simulation of observational data. Drug Saf. 2013;36(S1):171–180.
    • (2013) Drug Saf , vol.36 , Issue.S1 , pp. 171-180
    • Ryan, P.B.1    Schuemie, M.J.2
  • 59
    • 84892947900 scopus 로고    scopus 로고
    • Replication of the OMOP experiment in Europe: evaluating methods for risk identification in electronic health record databases
    • Schuemie MJ, Gini R, Coloma PM, et al. Replication of the OMOP experiment in Europe:evaluating methods for risk identification in electronic health record databases. Drug Saf. 2013;36(S1):159–169.•• Study presenting the EU-ADR experiment that implemented and assessed in European data the methods based on disproportionality analysis, traditional pharmacoepidemiological designs.
    • (2013) Drug Saf , vol.36 , Issue.S1 , pp. 159-169
    • Schuemie, M.J.1    Gini, R.2    Coloma, P.M.3
  • 60
    • 85194972808 scopus 로고    scopus 로고
    • Regression shrinkage and selection via the Lasso
    • Tibshirani R. Regression shrinkage and selection via the Lasso. J R Stat Soc Ser B Methodol. 1996;58(1):267–288.
    • (1996) J R Stat Soc Ser B Methodol , vol.58 , Issue.1 , pp. 267-288
    • Tibshirani, R.1
  • 61
    • 0023757062 scopus 로고
    • Prescription sequence analysis: a new and fast method for assessing certain adverse reactions of prescription drugs in large populations
    • Petri H, De Vet HCW, Naus J, et al. Prescription sequence analysis:a new and fast method for assessing certain adverse reactions of prescription drugs in large populations. Stat Med. 1988;7(11):1171–1175.• The first study to have described the SSA, a smart method for safety signal detection in observational health-care databases.
    • (1988) Stat Med , vol.7 , Issue.11 , pp. 1171-1175
    • Petri, H.1    De Vet, H.C.W.2    Naus, J.3
  • 62
    • 68149161675 scopus 로고    scopus 로고
    • Adverse events with use of antiepileptic drugs: a prescription and event symmetry analysis
    • Tsiropoulos I, Andersen M, Hallas J. Adverse events with use of antiepileptic drugs:a prescription and event symmetry analysis. Pharmacoepidemiol Drug Saf. 2009;18(6):483–491.
    • (2009) Pharmacoepidemiol Drug Saf , vol.18 , Issue.6 , pp. 483-491
    • Tsiropoulos, I.1    Andersen, M.2    Hallas, J.3
  • 63
    • 84862908275 scopus 로고    scopus 로고
    • Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the mini-sentinel pilot
    • Cook AJ, Tiwari RC, Wellman RD, et al. Statistical approaches to group sequential monitoring of postmarket safety surveillance data:current state of the art for use in the mini-sentinel pilot. Pharmacoepidemiol Drug Saf. 2012;21:72–81.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , pp. 72-81
    • Cook, A.J.1    Tiwari, R.C.2    Wellman, R.D.3
  • 64
    • 79955666806 scopus 로고    scopus 로고
    • A potential causal association mining algorithm for screening adverse drug reactions in postmarketing surveillance
    • Ji Y, Ying H, Dews P, et al. A potential causal association mining algorithm for screening adverse drug reactions in postmarketing surveillance. IEEE Trans Inf Technol Biomed. 2011;15(3):428–437.
    • (2011) IEEE Trans Inf Technol Biomed , vol.15 , Issue.3 , pp. 428-437
    • Ji, Y.1    Ying, H.2    Dews, P.3
  • 65
    • 84874596859 scopus 로고    scopus 로고
    • A method for mining infrequent causal associations and its application in finding adverse drug reaction signal pairs
    • Ji Y, Ying H, Tran J, et al. A method for mining infrequent causal associations and its application in finding adverse drug reaction signal pairs. IEEE Trans Knowl Data Eng. 2013;25(4):721–733.
    • (2013) IEEE Trans Knowl Data Eng , vol.25 , Issue.4 , pp. 721-733
    • Ji, Y.1    Ying, H.2    Tran, J.3
  • 66
    • 0037869537 scopus 로고    scopus 로고
    • A tree-based scan statistic for database disease surveillance
    • Kulldorff M, Fang Z, Walsh SJ. A tree-based scan statistic for database disease surveillance. Biometrics. 2003;59(2):323–331.
    • (2003) Biometrics , vol.59 , Issue.2 , pp. 323-331
    • Kulldorff, M.1    Fang, Z.2    Walsh, S.J.3
  • 67
    • 84879988282 scopus 로고    scopus 로고
    • Design and validation of an automated method to detect known adverse drug reactions in MEDLINE: a contribution from the EU–ADR project
    • Avillach P, Dufour J-C, Diallo G, et al. Design and validation of an automated method to detect known adverse drug reactions in MEDLINE:a contribution from the EU–ADR project. J Am Med Inform Assoc. 2013;20(3):446–452.
    • (2013) J Am Med Inform Assoc , vol.20 , Issue.3 , pp. 446-452
    • Avillach, P.1    Dufour, J.-C.2    Diallo, G.3
  • 68
    • 84876548863 scopus 로고    scopus 로고
    • A reference standard for evaluation of methods for drug safety signal detection using electronic healthcare record databases
    • Coloma PM, Avillach P, Salvo F, et al. A reference standard for evaluation of methods for drug safety signal detection using electronic healthcare record databases. Drug Saf. 2013;36(1):13–23.
    • (2013) Drug Saf , vol.36 , Issue.1 , pp. 13-23
    • Coloma, P.M.1    Avillach, P.2    Salvo, F.3
  • 69
    • 84892918936 scopus 로고    scopus 로고
    • Defining a reference set to support methodological research in drug safety
    • Ryan PB, Schuemie MJ, Welebob E, et al. Defining a reference set to support methodological research in drug safety. Drug Saf. 2013;36(S1):33–47.
    • (2013) Drug Saf , vol.36 , Issue.S1 , pp. 33-47
    • Ryan, P.B.1    Schuemie, M.J.2    Welebob, E.3
  • 70
    • 84888036811 scopus 로고    scopus 로고
    • Comparison of algorithms that detect drug side effects using electronic healthcare databases
    • Reps JM, Garibaldi JM, Aickelin U, et al. Comparison of algorithms that detect drug side effects using electronic healthcare databases. Soft Comput. 2013;17(12):2381–2397.•• Study presenting and comparing the performance for signal detection of the methods based on TAR algorithms.
    • (2013) Soft Comput , vol.17 , Issue.12 , pp. 2381-2397
    • Reps, J.M.1    Garibaldi, J.M.2    Aickelin, U.3
  • 71
    • 84877629294 scopus 로고    scopus 로고
    • The validity of sequence symmetry analysis (SSA) for adverse drug reaction signal detection
    • Wahab IA, Pratt NL, Wiese MD, et al. The validity of sequence symmetry analysis (SSA) for adverse drug reaction signal detection. Pharmacoepidemiol Drug Saf. 2013;22(5):496–502.•• Study demonstrating that the SSA performed pretty well for safety signal detection.
    • (2013) Pharmacoepidemiol Drug Saf , vol.22 , Issue.5 , pp. 496-502
    • Wahab, I.A.1    Pratt, N.L.2    Wiese, M.D.3
  • 72
    • 85027943139 scopus 로고    scopus 로고
    • Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association
    • Gruber S, Chakravarty A, Heckbert SR, et al. Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association. Pharmacoepidemiol Drug Saf. 2016;25:973–981.
    • (2016) Pharmacoepidemiol Drug Saf , vol.25 , pp. 973-981
    • Gruber, S.1    Chakravarty, A.2    Heckbert, S.R.3
  • 73
    • 84873958498 scopus 로고    scopus 로고
    • Comment on “Empirical assessment of methods for risk identification in healthcare data: results from the experiments of the observational medical outcomes partnership
    • Gagne JJ, Schneeweiss S. Comment on “Empirical assessment of methods for risk identification in healthcare data:results from the experiments of the observational medical outcomes partnership.”. Stat Med. 2013;32(6):1073–1074.
    • (2013) Stat Med , vol.32 , Issue.6 , pp. 1073-1074
    • Gagne, J.J.1    Schneeweiss, S.2
  • 74
    • 84925503218 scopus 로고    scopus 로고
    • Comment on: “Desideratum for evidence-based epidemiology
    • Hennessy S, Leonard CE. Comment on:“Desideratum for evidence-based epidemiology.”. Drug Saf. 2015;38(1):101–103.
    • (2015) Drug Saf , vol.38 , Issue.1 , pp. 101-103
    • Hennessy, S.1    Leonard, C.E.2
  • 75
    • 84892913485 scopus 로고    scopus 로고
    • How well do various health outcome definitions identify appropriate cases in observational studies?
    • Hansen RA, Gray MD, Fox BI, et al. How well do various health outcome definitions identify appropriate cases in observational studies? Drug Saf. 2013;36(S1):27–32.
    • (2013) Drug Saf , vol.36 , Issue.S1 , pp. 27-32
    • Hansen, R.A.1    Gray, M.D.2    Fox, B.I.3
  • 76
    • 84901693274 scopus 로고    scopus 로고
    • The performance of sequence symmetry analysis as a tool for post-market surveillance of newly marketed medicines: a simulation study
    • Pratt NL, Ilomäki J, Raymond C, et al. The performance of sequence symmetry analysis as a tool for post-market surveillance of newly marketed medicines:a simulation study. BMC Med Res Methodol. 2014;14(1):1.
    • (2014) BMC Med Res Methodol , vol.14 , Issue.1 , pp. 1
    • Pratt, N.L.1    Ilomäki, J.2    Raymond, C.3
  • 77
    • 84882626723 scopus 로고    scopus 로고
    • Multi-country rapid adverse drug event assessment: the Asian pharmacoepidemiology network (AsPEN) antipsychotic and acute hyperglycaemia study
    • Pratt N, Andersen M, Bergman U, et al. Multi-country rapid adverse drug event assessment:the Asian pharmacoepidemiology network (AsPEN) antipsychotic and acute hyperglycaemia study. Pharmacoepidemiol Drug Saf. 2013;22:915–924.
    • (2013) Pharmacoepidemiol Drug Saf , vol.22 , pp. 915-924
    • Pratt, N.1    Andersen, M.2    Bergman, U.3
  • 78
    • 84939001135 scopus 로고    scopus 로고
    • Prescription sequence symmetry analysis: assessing risk, temporality, and consistency for adverse drug reactions across datasets in five countries
    • Pratt N, Chan EW, Choi N-K, et al. Prescription sequence symmetry analysis:assessing risk, temporality, and consistency for adverse drug reactions across datasets in five countries. Pharmacoepidemiol Drug Saf. 2015;24(8):858–864.
    • (2015) Pharmacoepidemiol Drug Saf , vol.24 , Issue.8 , pp. 858-864
    • Pratt, N.1    Chan, E.W.2    Choi, N.-K.3
  • 79
    • 84961201241 scopus 로고    scopus 로고
    • Sequence symmetry analysis as a signal detection tool for potential heart failure adverse events in an administrative claims database
    • Wahab IA, Pratt NL, Ellett LK, et al. Sequence symmetry analysis as a signal detection tool for potential heart failure adverse events in an administrative claims database. Drug Saf. 2016;39(4):347–354.• Study demonstrating that the SSA method is able to identify unknown ADRs, which are supported by biological plausibility and case reports.
    • (2016) Drug Saf , vol.39 , Issue.4 , pp. 347-354
    • Wahab, I.A.1    Pratt, N.L.2    Ellett, L.K.3
  • 80
    • 77957988489 scopus 로고    scopus 로고
    • Class prediction for high-dimensional class-imbalanced data
    • Blagus R, Lusa L. Class prediction for high-dimensional class-imbalanced data. BMC Bioinformatics. 2010;11(1):523.
    • (2010) BMC Bioinformatics , vol.11 , Issue.1 , pp. 523
    • Blagus, R.1    Lusa, L.2
  • 81
    • 85019846576 scopus 로고    scopus 로고
    • , December
    • The Uppsala Monitoring Centre. Practical Pharmacovigilance. Signal definition. 2013. Available at:http://www.who-umc.org [Last accessed 13December 2016]
    • (2013) Signal definition
  • 82
    • 33646790167 scopus 로고    scopus 로고
    • Tutorial in biostatistics: the self-controlled case series method
    • Whitaker HJ, Paddy Farrington C, Spiessens B, et al. Tutorial in biostatistics:the self-controlled case series method. Stat Med. 2006;25(10):1768–1797.
    • (2006) Stat Med , vol.25 , Issue.10 , pp. 1768-1797
    • Whitaker, H.J.1    Paddy Farrington, C.2    Spiessens, B.3


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