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Volumn 19, Issue 8, 2010, Pages 858-868

A basic study design for expedited safety signal evaluation based on electronic healthcare data

Author keywords

Cohort study; Healthcare databases; Incident user design; Pharmacoepidemiology; Propensity scores; Sentinel system

Indexed keywords

CONFERENCE PAPER; DRUG MONITORING; DRUG SAFETY; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL; SENSITIVITY ANALYSIS; STATISTICAL ANALYSIS;

EID: 77956625112     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1926     Document Type: Conference Paper
Times cited : (214)

References (37)
  • 2
    • 68849123390 scopus 로고    scopus 로고
    • Managing drug-risk information - What to do with all those new numbers
    • Avorn J, Schneeweiss S. Managing drug-risk information - what to do with all those new numbers. N Engl J Med 2009; 361: 647-649.
    • (2009) N Engl J Med , vol.361 , pp. 647-649
    • Avorn, J.1    Schneeweiss, S.2
  • 4
    • 77952766373 scopus 로고    scopus 로고
    • Orthogonal predictions: Follow-up questions for suggestive data
    • in press
    • Walker AM. Orthogonal predictions: follow-up questions for suggestive data. Pharmacoepidemiol Drug Saf 2010; in press.
    • (2010) Pharmacoepidemiol Drug Saf
    • Walker, A.M.1
  • 5
    • 13744260134 scopus 로고    scopus 로고
    • Adjusting for unmeasured confounders in pharmacoepidemiologic claims data using external information: The example of COX2 inhibitors and myocardial infarction
    • Schneeweiss S, Glynn RJ, Tsai EH, Avorn J, Solomon DH. Adjusting for unmeasured confounders in pharmacoepidemiologic claims data using external information: the example of COX2 inhibitors and myocardial infarction. Epidemiology 2005; 16: 17-24.
    • (2005) Epidemiology , vol.16 , pp. 17-24
    • Schneeweiss, S.1    Glynn, R.J.2    Tsai, E.H.3    Avorn, J.4    Solomon, D.H.5
  • 6
    • 0347447334 scopus 로고    scopus 로고
    • A propensity score-matched cohort study of the effect of statins, mainly fluvastatin, on the occurrence of acute myocardial infarction
    • Seeger JD, Walker AM, Williams PL, Saperia GM, Sacks FM. A propensity score-matched cohort study of the effect of statins, mainly fluvastatin, on the occurrence of acute myocardial infarction. Am J Cardiol 2003; 92: 1447-1451.
    • (2003) Am J Cardiol , vol.92 , pp. 1447-1451
    • Seeger, J.D.1    Walker, A.M.2    Williams, P.L.3    Saperia, G.M.4    Sacks, F.M.5
  • 7
    • 0033942150 scopus 로고    scopus 로고
    • Causal effects in clinical and epidemiological studies via potential outcomes: Concepts and analytical approaches
    • Little RJ, Rubin DB. Causal effects in clinical and epidemiological studies via potential outcomes: concepts and analytical approaches. Annu Rev Public Health 2000; 21: 121-145.
    • (2000) Annu Rev Public Health , vol.21 , pp. 121-145
    • Little, R.J.1    Rubin, D.B.2
  • 8
    • 0025975160 scopus 로고
    • The case-crossover design: A method for studying transient effects on the risk of acute events
    • Maclure M. The case-crossover design: a method for studying transient effects on the risk of acute events. Am J Epidemiol 1991; 133: 144-153.
    • (1991) Am J Epidemiol , vol.133 , pp. 144-153
    • Maclure, M.1
  • 9
    • 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: 323-337.
    • (2005) J Clin Epidemiol , vol.58 , pp. 323-337
    • Schneeweiss, S.1    Avorn, J.2
  • 10
    • 0142157169 scopus 로고    scopus 로고
    • Evaluating medication effects outside of clinical trials: New-user designs
    • Ray WA. Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol 2003; 158: 915-920.
    • (2003) Am J Epidemiol , vol.158 , pp. 915-920
    • Ray, W.A.1
  • 11
    • 34848820064 scopus 로고    scopus 로고
    • Increasing levels of restriction in pharmacoepidemiologic database studies of elderly and comparison with randomized trial results
    • Schneeweiss S, Patrick AR, Sturmer T, et al. Increasing levels of restriction in pharmacoepidemiologic database studies of elderly and comparison with randomized trial results. Med care 2007; 45: S131-S142.
    • (2007) Med Care , vol.45
    • Schneeweiss, S.1    Patrick, A.R.2    Sturmer, T.3
  • 12
    • 67651021231 scopus 로고    scopus 로고
    • Overadjustment bias and unnecessary adjustment in epidemiologic studies
    • Schisterman EF, Cole SR, Platt RW. Overadjustment bias and unnecessary adjustment in epidemiologic studies. Epidemiology 2009; 20: 488-495.
    • (2009) Epidemiology , vol.20 , pp. 488-495
    • Schisterman, E.F.1    Cole, S.R.2    Platt, R.W.3
  • 13
    • 39349101029 scopus 로고    scopus 로고
    • Immortal time bias in pharmaco-epidemiology
    • Suissa S. Immortal time bias in pharmaco-epidemiology. Am J Epidemiol 2008; 167: 492-499.
    • (2008) Am J Epidemiol , vol.167 , pp. 492-499
    • Suissa, S.1
  • 14
    • 0027968619 scopus 로고
    • Evidence of the depletion of susceptibles effect in non-experimental pharmacoepidemiologic research
    • Moride Y, Abenhaim L. Evidence of the depletion of susceptibles effect in non-experimental pharmacoepidemiologic research. J Clin Epidemiol 1994; 47: 731-737.
    • (1994) J Clin Epidemiol , vol.47 , pp. 731-737
    • Moride, Y.1    Abenhaim, L.2
  • 15
    • 42449095405 scopus 로고    scopus 로고
    • The risk of infection associated with tumor necrosis factor a antagonists: Making sense of epidemiologic evidence
    • Solomon DH, Lunt M, Schneeweiss S. The risk of infection associated with tumor necrosis factor a antagonists: making sense of epidemiologic evidence. Arthritis Rheum 2008; 58: 919-928.
    • (2008) Arthritis Rheum , vol.58 , pp. 919-928
    • Solomon, D.H.1    Lunt, M.2    Schneeweiss, S.3
  • 16
    • 0026071495 scopus 로고
    • Practical considerations in choosing between the case-cohort and nested case-control designs
    • Wacholder S. Practical considerations in choosing between the case-cohort and nested case-control designs. Epidemiology 1991; 2: 155-158.
    • (1991) Epidemiology , vol.2 , pp. 155-158
    • Wacholder, S.1
  • 18
    • 3142651905 scopus 로고    scopus 로고
    • Accuracy of Medicare claims-based diagnosis of acute myocardial infarction: Estimating positive predictive value on the basis of review of hospital records
    • Kiyota Y, Schneeweiss S, Glynn RJ, Cannuscio CC, Avorn J, Solomon DH. Accuracy of Medicare claims-based diagnosis of acute myocardial infarction: estimating positive predictive value on the basis of review of hospital records. Am Heart J 2004; 148: 99-104.
    • (2004) Am Heart J , vol.148 , pp. 99-104
    • Kiyota, Y.1    Schneeweiss, S.2    Glynn, R.J.3    Cannuscio, C.C.4    Avorn, J.5    Solomon, D.H.6
  • 19
    • 0025031812 scopus 로고
    • No adjustments are needed for multiple comparisons
    • Rothman KJ. No adjustments are needed for multiple comparisons. Epidemiology 1990; 1: 43-46.
    • (1990) Epidemiology , vol.1 , pp. 43-46
    • Rothman, K.J.1
  • 20
    • 33645895554 scopus 로고    scopus 로고
    • The challenge of subgroup analyses - Reporting without distorting
    • Lagakos SW. The challenge of subgroup analyses - reporting without distorting. N Engl J Med 2006; 354: 1667-1669.
    • (2006) N Engl J Med , vol.354 , pp. 1667-1669
    • Lagakos, S.W.1
  • 21
    • 0141729308 scopus 로고    scopus 로고
    • Approaches to combat with confounding by indication in observational studies of intended drug effects
    • McMahon AD. Approaches to combat with confounding by indication in observational studies of intended drug effects. Pharmacoepidemiol Drug Saf 2003; 12: 551-558.
    • (2003) Pharmacoepidemiol Drug Saf , vol.12 , pp. 551-558
    • McMahon, A.D.1
  • 22
    • 33744495314 scopus 로고    scopus 로고
    • Sensitivity analysis and external adjustment for unmeasured confounders in epidemiologic database studies of therapeutics
    • Schneeweiss S. Sensitivity analysis and external adjustment for unmeasured confounders in epidemiologic database studies of therapeutics. Pharmacoepidemiol Drug Saf 2006; 15: 291-303.
    • (2006) Pharmacoepidemiol Drug Saf , vol.15 , pp. 291-303
    • Schneeweiss, S.1
  • 24
    • 67651042983 scopus 로고    scopus 로고
    • High-dimensional propensity score adjustment in studies of treatment effects using health care claims data
    • Schneeweiss S, Rassen JA, Glynn RJ, Avorn J, Mogun H, Brookhart MA. High-dimensional propensity score adjustment in studies of treatment effects using health care claims data. Epidemiology 2009; 20: 512-522.
    • (2009) Epidemiology , vol.20 , pp. 512-522
    • Schneeweiss, S.1    Rassen, J.A.2    Glynn, R.J.3    Avorn, J.4    Mogun, H.5    Brookhart, M.A.6
  • 25
    • 44649173785 scopus 로고    scopus 로고
    • A critical appraisal of propensity-score matching in the medical literature between 1996 and 2003
    • Austin PC. A critical appraisal of propensity-score matching in the medical literature between 1996 and 2003. Stat Med 2008; 27: 2037-2049.
    • (2008) Stat Med , vol.27 , pp. 2037-2049
    • Austin, P.C.1
  • 26
    • 31344433620 scopus 로고    scopus 로고
    • Results of multivariable logistic regression, propensity matching, propensity adjustment, and propensity- Based weighting under conditions of nonuniform effect
    • Kurth T, Walker AM, Glynn RJ, et al. Results of multivariable logistic regression, propensity matching, propensity adjustment, and propensity- based weighting under conditions of nonuniform effect. Am J Epidemiol 2006; 163: 262-270.
    • (2006) Am J Epidemiol , vol.163 , pp. 262-270
    • Kurth, T.1    Walker, A.M.2    Glynn, R.J.3
  • 27
    • 63149083464 scopus 로고    scopus 로고
    • Different methods of balancing covariates leading to different effect estimates in the presence of effect modification
    • Lunt M, Solomon D, Rothman K, et al. Different methods of balancing covariates leading to different effect estimates in the presence of effect modification. Am J Epidemiol 2009; 169: 909-917.
    • (2009) Am J Epidemiol , vol.169 , pp. 909-917
    • Lunt, M.1    Solomon, D.2    Rothman, K.3
  • 28
    • 75749154403 scopus 로고    scopus 로고
    • An application of propensity score methods to estimate the treatment effect of corticosteroids in patients with severe cutaneous adverse reactions
    • Sekula P, Caputo A, Dunant A, et al. An application of propensity score methods to estimate the treatment effect of corticosteroids in patients with severe cutaneous adverse reactions. Pharmacoepidemiol Drug Saf 2010; 19: 10-18.
    • (2010) Pharmacoepidemiol Drug Saf , vol.19 , pp. 10-18
    • Sekula, P.1    Caputo, A.2    Dunant, A.3
  • 30
    • 61449524241 scopus 로고    scopus 로고
    • Observational studies analyzed like randomized experiments: An application to postmenopausal hormone therapy and coronary heart disease
    • Hernan MA, Alonso A, Logan R, et al. Observational studies analyzed like randomized experiments: an application to postmenopausal hormone therapy and coronary heart disease. Epidemiology 2008; 19: 766-779.
    • (2008) Epidemiology , vol.19 , pp. 766-779
    • Hernan, M.A.1    Alonso, A.2    Logan, R.3
  • 31
    • 33646802964 scopus 로고    scopus 로고
    • Evaluating short-term drug effects using a physician-specific prescribing preference as an instrumental variable
    • Brookhart MA, Wang PS, Solomon DH, Schneeweiss S. Evaluating short-term drug effects using a physician-specific prescribing preference as an instrumental variable. Epidemiology 2006; 17: 268-275.
    • (2006) Epidemiology , vol.17 , pp. 268-275
    • Brookhart, M.A.1    Wang, P.S.2    Solomon, D.H.3    Schneeweiss, S.4
  • 32
    • 33947264305 scopus 로고    scopus 로고
    • Risk of death associated with the use of conventional versus atypical antipsychotic drugs among elderly patients
    • [see comment][erratum appears in CMAJ. 2007 May 22;176(11):1613]
    • Schneeweiss S, Setoguchi S, Brookhart A, Dormuth C, Wang PS. Risk of death associated with the use of conventional versus atypical antipsychotic drugs among elderly patients.[see comment][erratum appears in CMAJ. 2007 May 22;176(11):1613].CMAJ 2007; 176: 627-632.
    • (2007) CMAJ , vol.176 , pp. 627-632
    • Schneeweiss, S.1    Setoguchi, S.2    Brookhart, A.3    Dormuth, C.4    Wang, P.S.5
  • 33
    • 0017226637 scopus 로고
    • Estimability and estimation in case-referent studies
    • Miettinen O. Estimability and estimation in case-referent studies. Am J Epidemiol 1976; 103: 226-235.
    • (1976) Am J Epidemiol , vol.103 , pp. 226-235
    • Miettinen, O.1
  • 34
    • 0030038950 scopus 로고    scopus 로고
    • The case-control study as data missing by design: Estimating risk differences
    • Wacholder S. The case-control study as data missing by design: estimating risk differences. Epidemiology 1996; 7: 144-150.
    • (1996) Epidemiology , vol.7 , pp. 144-150
    • Wacholder, S.1
  • 35
    • 0004292914 scopus 로고    scopus 로고
    • (3rd Edition) Lippincott Williams & Wilkins: Philadelphia
    • Rothman KJ. Modern Epidemiology (3rd Edition) Lippincott Williams & Wilkins: Philadelphia, 2008.
    • (2008) Modern Epidemiology
    • Rothman, K.J.1
  • 36
    • 70549111209 scopus 로고    scopus 로고
    • Non-aspirin NSAIDs, cyclooxygenase-2 inhibitors and risk for cardiovascular events-stroke, acute myocardial infarction, and death from coronary heart disease
    • Roumie CL, Choma NN, Kaltenbach L, Mitchel EF Jr, Arbogast PG, Griffin MR. Non-aspirin NSAIDs, cyclooxygenase-2 inhibitors and risk for cardiovascular events-stroke, acute myocardial infarction, and death from coronary heart disease. Pharmacoepidemiol Drug Saf 2009; 18: 1053-1063.
    • (2009) Pharmacoepidemiol Drug Saf , vol.18 , pp. 1053-1063
    • Roumie, C.L.1    Choma, N.N.2    Kaltenbach, L.3    Mitchel Jr., E.F.4    Arbogast, P.G.5    Griffin, M.R.6
  • 37
    • 84972969037 scopus 로고
    • Correcting for non-compliance in randomized trials using structural nested mean models
    • Robins JM. Correcting for non-compliance in randomized trials using structural nested mean models. Commun Stat Theory Methods 1994; 23: 2379-2412.
    • (1994) Commun Stat Theory Methods , vol.23 , pp. 2379-2412
    • Robins, J.M.1


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