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Volumn 102, Issue 6, 2017, Pages 924-933

When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials?

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DATA ANALYSIS; DATA BASE; DECISION MAKING; DRUG COST; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; EVIDENCE BASED PRACTICE; GOLD STANDARD; HEALTH CARE; HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REGISTER; SENSITIVITY ANALYSIS; STUDY DESIGN; TREATMENT DURATION; VALIDITY; DRUG APPROVAL; FACTUAL DATABASE; INFORMATION PROCESSING; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICS;

EID: 85029886626     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.857     Document Type: Article
Times cited : (203)

References (79)
  • 3
    • 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. 58, 323–337 (2005).
    • (2005) J. Clin. Epidemiol. , vol.58 , pp. 323-337
    • Schneeweiss, S.1    Avorn, J.2
  • 4
    • 81355139590 scopus 로고    scopus 로고
    • Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development
    • Schneeweiss, S., Gagne, J.J., Glynn, R.J., Ruhl, M. & Rassen, J.A. Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development. Clin. Pharmacol. Ther. 90, 777–790 (2011).
    • (2011) Clin. Pharmacol. Ther. , vol.90 , pp. 777-790
    • Schneeweiss, S.1    Gagne, J.J.2    Glynn, R.J.3    Ruhl, M.4    Rassen, J.A.5
  • 5
    • 84958977307 scopus 로고    scopus 로고
    • Improving therapeutic effectiveness and safety through big healthcare data
    • Schneeweiss, S. Improving therapeutic effectiveness and safety through big healthcare data. Clin. Pharmacol. Ther. 99, 262–265 (2016).
    • (2016) Clin. Pharmacol. Ther. , vol.99 , pp. 262-265
    • Schneeweiss, S.1
  • 6
    • 84862777400 scopus 로고    scopus 로고
    • Adaptive licensing: taking the next step in the evolution of drug approval
    • Eichler, H.G. et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin. Pharmacol. Ther. 91, 426–437 (2012).
    • (2012) Clin. Pharmacol. Ther. , vol.91 , pp. 426-437
    • Eichler, H.G.1
  • 7
    • 84927675287 scopus 로고    scopus 로고
    • From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients
    • Eichler, H.G. et al. From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients. Clin. Pharmacol. Ther. 97, 234–246 (2015).
    • (2015) Clin. Pharmacol. Ther. , vol.97 , pp. 234-246
    • Eichler, H.G.1
  • 8
    • 85002412626 scopus 로고    scopus 로고
    • Real-world evidence—what is it and what can it tell us
    • Sherman, R.E. et al. Real-world evidence—what is it and what can it tell us. N. Engl. J. Med. 375, 2293–2297 (2016).
    • (2016) N. Engl. J. Med. , vol.375 , pp. 2293-2297
    • Sherman, R.E.1
  • 9
    • 84901502488 scopus 로고    scopus 로고
    • Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. The Cochrane Collaboration
    • &, (John Wiley & Sons, Chichester, UK,,). <, >. Accessed 12 May 2016
    • Anglemyer, A., Horvath, H.T. & Bero, L. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. The Cochrane Collaboration. Cochrane Database of Systematic Reviews. (John Wiley & Sons, Chichester, UK, 2014). . Accessed 12 May 2016.
    • (2014) Cochrane Database of Systematic Reviews.
    • Anglemyer, A.1    Horvath, H.T.2    Bero, L.3
  • 10
    • 0034702175 scopus 로고    scopus 로고
    • Randomized, controlled trials, observational studies, and the hierarchy of research designs
    • Concato, J., Shah, N. & Horwitz, R.I. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N. Engl. J. Med. 342, 1887–1892 (2000).
    • (2000) N. Engl. J. Med. , vol.342 , pp. 1887-1892
    • Concato, J.1    Shah, N.2    Horwitz, R.I.3
  • 11
    • 0035880296 scopus 로고    scopus 로고
    • Comparison of evidence of treatment effects in randomized and nonrandomized studies
    • Ioannidis, J.P. et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA 286, 821–830 (2001).
    • (2001) JAMA , vol.286 , pp. 821-830
    • Ioannidis, J.P.1
  • 12
    • 1342326075 scopus 로고    scopus 로고
    • Hierarchy of evidence: differences in results between non-randomized studies and randomized trials in patients with femoral neck fractures
    • Bhandari, M. et al. Hierarchy of evidence: differences in results between non-randomized studies and randomized trials in patients with femoral neck fractures. Arch. Orthop. Trauma Surg. 124, 10–16 (2004).
    • (2004) Arch. Orthop. Trauma Surg. , vol.124 , pp. 10-16
    • Bhandari, M.1
  • 13
    • 84864626015 scopus 로고    scopus 로고
    • Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes
    • Dahabreh, I.J. et al. Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes. Eur. Heart J. 33, 1893–1901 (2012).
    • (2012) Eur. Heart J. , vol.33 , pp. 1893-1901
    • Dahabreh, I.J.1
  • 14
    • 84891629707 scopus 로고    scopus 로고
    • Comparison of treatment effect estimates from prospective nonrandomized studies with propensity score analysis and randomized controlled trials of surgical procedures
    • Lonjon, G. et al. Comparison of treatment effect estimates from prospective nonrandomized studies with propensity score analysis and randomized controlled trials of surgical procedures. Ann. Surg. 259, 18–25 (2014).
    • (2014) Ann. Surg. , vol.259 , pp. 18-25
    • Lonjon, G.1
  • 15
    • 84960156608 scopus 로고    scopus 로고
    • Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey
    • Hemkens, L.G., Contopoulos-Ioannidis, D.G. & Ioannidis, J.P. Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey. BMJ 352, i493 (2016).
    • (2016) BMJ , vol.352 , pp. i493
    • Hemkens, L.G.1    Contopoulos-Ioannidis, D.G.2    Ioannidis, J.P.3
  • 16
    • 33846563409 scopus 로고    scopus 로고
    • Why most published research findings are false
    • Ioannidis, J.P. Why most published research findings are false. PLoS Med. 2, e124 (2005).
    • (2005) PLoS Med. , vol.2
    • Ioannidis, J.P.1
  • 18
    • 0025940856 scopus 로고
    • Postmenopausal estrogen therapy and cardiovascular disease: ten-year follow-up from the Nurses' Health Study
    • Stampfer, M.J. et al. Postmenopausal estrogen therapy and cardiovascular disease: ten-year follow-up from the Nurses' Health Study. N. Engl. J. Med. 325, 756–762 (1991).
    • (1991) N. Engl. J. Med. , vol.325 , pp. 756-762
    • Stampfer, M.J.1
  • 19
    • 0037125379 scopus 로고    scopus 로고
    • Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial
    • Rossouw, J.E. et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 288, 321–333 (2002).
    • (2002) JAMA , vol.288 , pp. 321-333
    • Rossouw, J.E.1
  • 20
    • 61449524241 scopus 로고    scopus 로고
    • Observational studies analyzed like randomized experiments: an application to postmenopausal hormone therapy and coronary heart disease
    • Hernán, M.A. et al. Observational studies analyzed like randomized experiments: an application to postmenopausal hormone therapy and coronary heart disease. Epidemiology 19, 766–779 (2008).
    • (2008) Epidemiology , vol.19 , pp. 766-779
    • Hernán, M.A.1
  • 21
    • 85014639703 scopus 로고    scopus 로고
    • Using design thinking to differentiate useful from misleading evidence in observational research
    • Goodman, S.N., Schneeweiss, S. & Baiocchi, M. Using design thinking to differentiate useful from misleading evidence in observational research. JAMA 317, 705–707 (2017).
    • (2017) JAMA , vol.317 , pp. 705-707
    • Goodman, S.N.1    Schneeweiss, S.2    Baiocchi, M.3
  • 22
    • 39549100109 scopus 로고    scopus 로고
    • Aprotinin during coronary-artery bypass grafting and risk of death
    • Schneeweiss, S., Seeger, J.D., Landon, J. & Walker, A.M. Aprotinin during coronary-artery bypass grafting and risk of death. N. Engl. J. Med. 358, 771–783 (2008).
    • (2008) N. Engl. J. Med. , vol.358 , pp. 771-783
    • Schneeweiss, S.1    Seeger, J.D.2    Landon, J.3    Walker, A.M.4
  • 23
    • 44349089188 scopus 로고    scopus 로고
    • A comparison of aprotinin and lysine analogues in high-risk cardiac surgery
    • Fergusson, D.A. et al. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. N. Engl. J. Med. 358, 2319–2331 (2008).
    • (2008) N. Engl. J. Med. , vol.358 , pp. 2319-2331
    • Fergusson, D.A.1
  • 24
    • 84978886151 scopus 로고    scopus 로고
    • Cardiovascular safety of glucagon-like peptide-1 receptor agonists versus other antidiabetic agents in routine care: a cohort study
    • [Epub ahead of print]
    • Patorno, E. et al. Cardiovascular safety of glucagon-like peptide-1 receptor agonists versus other antidiabetic agents in routine care: a cohort study. Diabetes Obes. Metab. (2016). [Epub ahead of print]
    • (2016) Diabetes Obes. Metab.
    • Patorno, E.1
  • 25
    • 85023777061 scopus 로고    scopus 로고
    • Canagliflozin and cardiovascular and renal events in type 2 diabetes
    • June
    • Neal, B. et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N. Engl. J. Med. June 2017. doi:10.1056/NEJMoa1611925.
    • (2017) N. Engl. J. Med.
    • Neal, B.1
  • 26
    • 0021127236 scopus 로고
    • Post-marketing studies of drug efficacy: how?
    • Strom, B.L., Miettinen, O.S. & Melmon, K.L. Post-marketing studies of drug efficacy: how? Am. J. Med. 77, 703–708 (1984).
    • (1984) Am. J. Med. , vol.77 , pp. 703-708
    • Strom, B.L.1    Miettinen, O.S.2    Melmon, K.L.3
  • 27
    • 0021999793 scopus 로고
    • Post-marketing studies of drug efficacy: why?
    • Strom, B.L., Melmon, K.L. & Miettinen, O.S. Post-marketing studies of drug efficacy: why? Am. J. Med. 78, 475–480 (1985).
    • (1985) Am. J. Med. , vol.78 , pp. 475-480
    • Strom, B.L.1    Melmon, K.L.2    Miettinen, O.S.3
  • 28
    • 84991704891 scopus 로고    scopus 로고
    • Real world data in adaptive biomedical innovation: a framework for generating evidence fit for decision-making
    • Schneeweiss, S. et al. Real world data in adaptive biomedical innovation: a framework for generating evidence fit for decision-making. Clin. Pharmacol. Ther. 100, 633–646 (2016).
    • (2016) Clin. Pharmacol. Ther. , vol.100 , pp. 633-646
    • Schneeweiss, S.1
  • 29
    • 0029988657 scopus 로고    scopus 로고
    • Prior to use of estrogen replacement therapy, are users healthier than nonusers?
    • Matthews, K.A., Kuller, L.H., Wing, R.R., Meilahn, E.N. & Plantinga, P. Prior to use of estrogen replacement therapy, are users healthier than nonusers? Am. J. Epidemiol. 143, 971–978 (1996).
    • (1996) Am. J. Epidemiol. , vol.143 , pp. 971-978
    • Matthews, K.A.1    Kuller, L.H.2    Wing, R.R.3    Meilahn, E.N.4    Plantinga, P.5
  • 30
    • 0035211416 scopus 로고    scopus 로고
    • Paradoxical relations of drug treatment with mortality in older persons
    • Glynn, R.J., Knight, E.L., Levin, R. & Avorn, J. Paradoxical relations of drug treatment with mortality in older persons. Epidemiology 12, 682–689 (2001).
    • (2001) Epidemiology , vol.12 , pp. 682-689
    • Glynn, R.J.1    Knight, E.L.2    Levin, R.3    Avorn, J.4
  • 31
    • 33645225508 scopus 로고    scopus 로고
    • Selective prescribing led to overestimation of the benefits of lipid-lowering drugs
    • Glynn, R., Schneeweiss, S., Wang, P., Levin, R. & Avorn, J. Selective prescribing led to overestimation of the benefits of lipid-lowering drugs. J. Clin. Epidemiol. 59, 819–828 (2006).
    • (2006) J. Clin. Epidemiol. , vol.59 , pp. 819-828
    • Glynn, R.1    Schneeweiss, S.2    Wang, P.3    Levin, R.4    Avorn, J.5
  • 32
    • 84900423293 scopus 로고    scopus 로고
    • Influence of healthy candidate bias in assessing clinical effectiveness for implantable cardioverter-defibrillators: cohort study of older patients with heart failure
    • Setoguchi, S. et al. Influence of healthy candidate bias in assessing clinical effectiveness for implantable cardioverter-defibrillators: cohort study of older patients with heart failure. BMJ 348, g2866 (2014).
    • (2014) BMJ , vol.348 , pp. g2866
    • Setoguchi, S.1
  • 33
    • 84919950480 scopus 로고    scopus 로고
    • Observational studies of the association between glucose-lowering medications and cardiovascular outcomes: addressing methodological limitations
    • Patorno, E. et al. Observational studies of the association between glucose-lowering medications and cardiovascular outcomes: addressing methodological limitations. Diabetologia 57, 2237–2250 (2014).
    • (2014) Diabetologia , vol.57 , pp. 2237-2250
    • Patorno, E.1
  • 34
    • 85033333293 scopus 로고    scopus 로고
    • The impact of study design and analysis on “measurable” and “un-measurable” patient characteristics in observational studies of glucose-lowering drugs in type 2 diabetes mellitus [abstract]
    • Patorno, E. et al. The impact of study design and analysis on “measurable” and “un-measurable” patient characteristics in observational studies of glucose-lowering drugs in type 2 diabetes mellitus [abstract]. Pharmacoepidemiol Drug Saf. 25, 44–45 (2016).
    • (2016) Pharmacoepidemiol Drug Saf. , vol.25 , pp. 44-45
    • Patorno, E.1
  • 35
    • 77956625112 scopus 로고    scopus 로고
    • A basic study design for expedited safety signal evaluation based on electronic healthcare data
    • Schneeweiss, S. A basic study design for expedited safety signal evaluation based on electronic healthcare data. Pharmacoepidemiol. Drug Saf. 19, 858–868 (2010).
    • (2010) Pharmacoepidemiol. Drug Saf. , vol.19 , pp. 858-868
    • Schneeweiss, S.1
  • 37
    • 0037027050 scopus 로고    scopus 로고
    • COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease
    • Ray, W.A., Stein, C.M., Daugherty, J.R., Hall, K., Arbogast, P.G. & Griffin, M.R. COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet 360, 1071–1073 (2002).
    • (2002) Lancet , vol.360 , pp. 1071-1073
    • Ray, W.A.1    Stein, C.M.2    Daugherty, J.R.3    Hall, K.4    Arbogast, P.G.5    Griffin, M.R.6
  • 38
    • 2442493150 scopus 로고    scopus 로고
    • Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults
    • Solomon, D.H. et al. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 109, 2068–2073 (2004).
    • (2004) Circulation , vol.109 , pp. 2068-2073
    • Solomon, D.H.1
  • 39
    • 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, R.J., Cannuscio, C.C., Avorn, J. & Solomon, D.H. 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. 148, 99–104 (2004).
    • (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
  • 40
    • 84978027801 scopus 로고    scopus 로고
    • Considerations for the analysis of longitudinal electronic health records linked to claims data to study the effectiveness and safety of drugs
    • Lin, K. & Schneeweiss, S. Considerations for the analysis of longitudinal electronic health records linked to claims data to study the effectiveness and safety of drugs. Clin. Pharmacol. Ther. 100, 147–159 (2016).
    • (2016) Clin. Pharmacol. Ther. , vol.100 , pp. 147-159
    • Lin, K.1    Schneeweiss, S.2
  • 41
    • 85019541936 scopus 로고    scopus 로고
    • Assessment of confounders in comparative effectiveness studies from secondary databases
    • Franklin, J.M., Schneeweiss, S. & Solomon, D.H. Assessment of confounders in comparative effectiveness studies from secondary databases. Am. J. Epidemiol. 185, 474–478 (2017).
    • (2017) Am. J. Epidemiol. , vol.185 , pp. 474-478
    • Franklin, J.M.1    Schneeweiss, S.2    Solomon, D.H.3
  • 42
    • 0031046049 scopus 로고    scopus 로고
    • The assessment of refill compliance using pharmacy records: methods, validity, and applications
    • Steiner, J.F. & Prochazka, A.V. The assessment of refill compliance using pharmacy records: methods, validity, and applications. J. Clin. Epidemiol. 50, 105–116 (1997).
    • (1997) J. Clin. Epidemiol. , vol.50 , pp. 105-116
    • Steiner, J.F.1    Prochazka, A.V.2
  • 44
    • 77951102841 scopus 로고    scopus 로고
    • Primary medication non-adherence: analysis of 195,930 electronic prescriptions
    • Fischer, M.A. et al. Primary medication non-adherence: analysis of 195,930 electronic prescriptions. J. Gen. Intern. Med. 25, 284–290 (2010).
    • (2010) J. Gen. Intern. Med. , vol.25 , pp. 284-290
    • Fischer, M.A.1
  • 45
    • 84897460376 scopus 로고    scopus 로고
    • The incidence and determinants of primary nonadherence with prescribed medication in primary care
    • Tamblyn, R., Eguale, T., Huang, A., Winslade, N. & Doran, P. The incidence and determinants of primary nonadherence with prescribed medication in primary care. Ann. Intern. Med. 160, 441–450 (2014).
    • (2014) Ann. Intern. Med. , vol.160 , pp. 441-450
    • Tamblyn, R.1    Eguale, T.2    Huang, A.3    Winslade, N.4    Doran, P.5
  • 46
    • 67651042983 scopus 로고    scopus 로고
    • High-dimensional propensity score adjustment in studies of treatment effects using health care claims data
    • Schneeweiss, S., Rassen, J.A., Glynn, R.J., Avorn, J., Mogun, H. & Brookhart, M.A. High-dimensional propensity score adjustment in studies of treatment effects using health care claims data. Epidemiology 20, 512–522 (2009).
    • (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
  • 47
    • 40949089705 scopus 로고    scopus 로고
    • Supplementary data collection with case - cohort analysis to address potential confounding in a cohort study of thromboembolism in oral contraceptive initiators matched on claims - based propensity scores
    • Eng, P., Seeger, J.D., Loughlin, J., Clifford, C.R., Mentor, B.A. & Walker, A.M. Supplementary data collection with case - cohort analysis to address potential confounding in a cohort study of thromboembolism in oral contraceptive initiators matched on claims - based propensity scores. Pharmacoepidemiol. Drug Saf. 17, 297–305 (2008).
    • (2008) Pharmacoepidemiol. Drug Saf. , vol.17 , pp. 297-305
    • Eng, P.1    Seeger, J.D.2    Loughlin, J.3    Clifford, C.R.4    Mentor, B.A.5    Walker, A.M.6
  • 48
    • 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. 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. 25, 973–981 (2016).
    • (2016) Pharmacoepidemiol. Drug Saf. , vol.25 , pp. 973-981
    • Gruber, S.1
  • 49
    • 67651021231 scopus 로고    scopus 로고
    • Overadjustment bias and unnecessary adjustment in epidemiologic studies
    • Schisterman, E.F., Cole, S.R. & Platt, R.W. Overadjustment bias and unnecessary adjustment in epidemiologic studies. Epidemiology 20, 488–495 (2009).
    • (2009) Epidemiology , vol.20 , pp. 488-495
    • Schisterman, E.F.1    Cole, S.R.2    Platt, R.W.3
  • 50
    • 33947227921 scopus 로고    scopus 로고
    • Immortal time bias in observational studies of drug effects
    • Suissa, S. Immortal time bias in observational studies of drug effects. Pharmacoepidemiol. Drug Saf. 16, 241–249 (2007).
    • (2007) Pharmacoepidemiol. Drug Saf. , vol.16 , pp. 241-249
    • Suissa, S.1
  • 51
    • 39349101029 scopus 로고    scopus 로고
    • Immortal time bias in pharmacoepidemiology
    • Suissa, S. Immortal time bias in pharmacoepidemiology. Am. J. Epidemiol. 167, 492–499 (2008).
    • (2008) Am. J. Epidemiol. , vol.167 , pp. 492-499
    • Suissa, S.1
  • 52
    • 85006299163 scopus 로고    scopus 로고
    • Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses
    • Hernán, M.A., Sauer, B.C., Hernández-Díaz, S., Platt, R. & Shrier, I. Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses. J. Clin. Epidemiol. 79, 70–75 (2016).
    • (2016) J. Clin. Epidemiol. , vol.79 , pp. 70-75
    • Hernán, M.A.1    Sauer, B.C.2    Hernández-Díaz, S.3    Platt, R.4    Shrier, I.5
  • 53
    • 85032147207 scopus 로고    scopus 로고
    • Comparative effectiveness research using observational data: active comparators to emulate target trials with inactive comparators
    • Huitfeldt, A., Hernan, M.A., Kalager, M. & Robins, J.M. Comparative effectiveness research using observational data: active comparators to emulate target trials with inactive comparators. EGEMS (Wash DC) 4, 1234 (2016).
    • (2016) EGEMS (Wash DC) , vol.4 , pp. 1234
    • Huitfeldt, A.1    Hernan, M.A.2    Kalager, M.3    Robins, J.M.4
  • 54
    • 0142157169 scopus 로고    scopus 로고
    • Evaluating medication effects outside of clinical trials: new-user designs
    • Ray, W.A. Evaluating medication effects outside of clinical trials: new-user designs. Am. J. Epidemiol. 158, 915–920 (2003).
    • (2003) Am. J. Epidemiol. , vol.158 , pp. 915-920
    • Ray, W.A.1
  • 55
    • 84872163962 scopus 로고    scopus 로고
    • The incident user design in comparative effectiveness research
    • Johnson, E.S. et al. The incident user design in comparative effectiveness research. Pharmacoepidemiol. Drug Saf. 22, 1–6 (2013).
    • (2013) Pharmacoepidemiol. Drug Saf. , vol.22 , pp. 1-6
    • Johnson, E.S.1
  • 56
    • 0141729308 scopus 로고    scopus 로고
    • Approaches to combat with confounding by indication in observational studies of intended drug effects
    • McMahon, A.D. Approaches to combat with confounding by indication in observational studies of intended drug effects. Pharmacoepidemiol. Drug Saf. 12, 551–558 (2003).
    • (2003) Pharmacoepidemiol. Drug Saf. , vol.12 , pp. 551-558
    • McMahon, A.D.1
  • 57
    • 77951622706 scopus 로고
    • The central role of the propensity score in observational studies for causal effects
    • Rosenbaum, P.R. & Rubin, D.B. The central role of the propensity score in observational studies for causal effects. Biometrika 70, 41–55 (1983).
    • (1983) Biometrika , vol.70 , pp. 41-55
    • Rosenbaum, P.R.1    Rubin, D.B.2
  • 58
    • 33645210305 scopus 로고    scopus 로고
    • Indications for propensity scores and review of their use in pharmacoepidemiology
    • Glynn, R.J., Schneeweiss, S. & Stürmer, T. Indications for propensity scores and review of their use in pharmacoepidemiology. Basic Clin. Pharmacol. Toxicol. 98, 253–259 (2006).
    • (2006) Basic Clin. Pharmacol. Toxicol. , vol.98 , pp. 253-259
    • Glynn, R.J.1    Schneeweiss, S.2    Stürmer, T.3
  • 59
    • 85013290379 scopus 로고    scopus 로고
    • Comparing the performance of propensity score methods in healthcare database studies with rare outcomes
    • Franklin, J.M., Eddings, W., Austin, P.C., Stuart, E.A. & Schneeweiss, S. Comparing the performance of propensity score methods in healthcare database studies with rare outcomes. Stat. Med. 36, 1946–1963 (2017).
    • (2017) Stat. Med. , vol.36 , pp. 1946-1963
    • Franklin, J.M.1    Eddings, W.2    Austin, P.C.3    Stuart, E.A.4    Schneeweiss, S.5
  • 61
    • 84890125193 scopus 로고    scopus 로고
    • Prospective cohort studies of newly marketed medications: using covariate data to inform the design of large-scale studies
    • Franklin, J.M., Rassen, J.A., Bartels, D.B. & Schneeweiss, S. Prospective cohort studies of newly marketed medications: using covariate data to inform the design of large-scale studies. Epidemiology 25, 126–133 (2014).
    • (2014) Epidemiology , vol.25 , pp. 126-133
    • Franklin, J.M.1    Rassen, J.A.2    Bartels, D.B.3    Schneeweiss, S.4
  • 62
    • 0346880128 scopus 로고    scopus 로고
    • Identification of causal effects using instrumental variables
    • Angrist, J.D., Imbens, G.W. & Rubin, D.B. Identification of causal effects using instrumental variables. J. Am. Stat. Assoc. 91, 444–455 (1996).
    • (1996) J. Am. Stat. Assoc. , vol.91 , pp. 444-455
    • Angrist, J.D.1    Imbens, G.W.2    Rubin, D.B.3
  • 63
    • 33646802964 scopus 로고    scopus 로고
    • Evaluating short-term drug effects using a physician-specific prescribing preference as an instrumental variable
    • Brookhart, M.A., Wang, P.S., Solomon, D.H. & Schneeweiss, S. Evaluating short-term drug effects using a physician-specific prescribing preference as an instrumental variable. Epidemiology 17, 268–275 (2006).
    • (2006) Epidemiology , vol.17 , pp. 268-275
    • Brookhart, M.A.1    Wang, P.S.2    Solomon, D.H.3    Schneeweiss, S.4
  • 64
    • 37849042876 scopus 로고    scopus 로고
    • Preference-based instrumental variable methods for the estimation of treatment effects: assessing validity and interpreting results
    • &, Article
    • Brookhart, M.A. & Schneeweiss, S. Preference-based instrumental variable methods for the estimation of treatment effects: assessing validity and interpreting results. Int. J. Biostat. 3, Article 14 (2007).
    • (2007) Int. J. Biostat , vol.3 , pp. 14
    • Brookhart, M.A.1    Schneeweiss, S.2
  • 65
    • 84904979483 scopus 로고    scopus 로고
    • Instrumental variable applications using nursing home prescribing preferences in comparative effectiveness research
    • Huybrechts, K.F., Gerhard, T., Franklin, J.M., Levin, R., Crystal, S. & Schneeweiss, S. Instrumental variable applications using nursing home prescribing preferences in comparative effectiveness research. Pharmacoepidemiol. Drug Saf. 23, 830–838 (2014).
    • (2014) Pharmacoepidemiol. Drug Saf. , vol.23 , pp. 830-838
    • Huybrechts, K.F.1    Gerhard, T.2    Franklin, J.M.3    Levin, R.4    Crystal, S.5    Schneeweiss, S.6
  • 67
    • 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. 15, 291–303 (2006).
    • (2006) Pharmacoepidemiol. Drug Saf. , vol.15 , pp. 291-303
    • Schneeweiss, S.1
  • 68
    • 84896736302 scopus 로고    scopus 로고
    • The control outcome calibration approach for causal inference with unobserved confounding
    • Tchetgen Tchetgen, E. The control outcome calibration approach for causal inference with unobserved confounding. Am. J. Epidemiol. 179, 633–640 (2014).
    • (2014) Am. J. Epidemiol. , vol.179 , pp. 633-640
    • Tchetgen Tchetgen, E.1
  • 69
    • 84961289660 scopus 로고    scopus 로고
    • Statins and congenital malformations: cohort study
    • Bateman, B.T. et al. Statins and congenital malformations: cohort study. BMJ 350, h1035 (2015).
    • (2015) BMJ , vol.350 , pp. h1035
    • Bateman, B.T.1
  • 70
    • 36849065071 scopus 로고    scopus 로고
    • Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies
    • von Elm, E., Altman, D., Egger, M., Pocock, S., Gøtzsche, P. & Vandenbroucke, J. Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet 370, 1453–1457 (2007).
    • (2007) Lancet , vol.370 , pp. 1453-1457
    • von Elm, E.1    Altman, D.2    Egger, M.3    Pocock, S.4    Gøtzsche, P.5    Vandenbroucke, J.6
  • 71
    • 84958956038 scopus 로고    scopus 로고
    • Transparency and reproducibility of observational cohort studies using large healthcare databases
    • Wang, S.V., Verpillat, P., Rassen, J.A., Patrick, A., Garry, E.M. & Bartels, D.B. Transparency and reproducibility of observational cohort studies using large healthcare databases. Clin. Pharmacol. Ther. 99, 325–332 (2016).
    • (2016) Clin. Pharmacol. Ther. , vol.99 , pp. 325-332
    • Wang, S.V.1    Verpillat, P.2    Rassen, J.A.3    Patrick, A.4    Garry, E.M.5    Bartels, D.B.6
  • 74
    • 0026782559 scopus 로고
    • The exclusion of the elderly and women from clinical trials in acute myocardial infarction
    • Gurwitz, J.H., Col, N.F. & Avorn, J. The exclusion of the elderly and women from clinical trials in acute myocardial infarction. JAMA J. Am. Med. Assoc. 268, 1417–1422 (1992).
    • (1992) JAMA J. Am. Med. Assoc. , vol.268 , pp. 1417-1422
    • Gurwitz, J.H.1    Col, N.F.2    Avorn, J.3
  • 75
    • 85062114271 scopus 로고    scopus 로고
    • A bias in the evaluation of bias comparing randomized trials with nonexperimental studies
    • &,). [Epub ahead of print]
    • Franklin, J.M., Dejene, S., Huybrechts, K.F., Wang, S.V. & Rothman, K.J. A bias in the evaluation of bias comparing randomized trials with nonexperimental studies. Epidemiol. Methods (2017). [Epub ahead of print]
    • (2017) Epidemiol. Methods
    • Franklin, J.M.1    Dejene, S.2    Huybrechts, K.F.3    Wang, S.V.4    Rothman, K.J.5
  • 76
    • 61849172253 scopus 로고    scopus 로고
    • Use of primary care electronic medical record database in drug efficacy research on cardiovascular outcomes: comparison of database and randomised controlled trial findings
    • Tannen, R.L., Weiner, M.G. & Xie, D. Use of primary care electronic medical record database in drug efficacy research on cardiovascular outcomes: comparison of database and randomised controlled trial findings. BMJ 338, b81 (2009).
    • (2009) BMJ , vol.338 , pp. b81
    • Tannen, R.L.1    Weiner, M.G.2    Xie, D.3
  • 77
    • 84874466891 scopus 로고    scopus 로고
    • Observational data for comparative effectiveness research: an emulation of randomised trials of statins and primary prevention of coronary heart disease
    • Danaei, G., Rodriguez, L.A., Cantero, O.F., Logan, R. & Hernán, M.A. Observational data for comparative effectiveness research: an emulation of randomised trials of statins and primary prevention of coronary heart disease. Stat. Methods Med. Res. 22, 70–96 (2013).
    • (2013) Stat. Methods Med. Res. , vol.22 , pp. 70-96
    • Danaei, G.1    Rodriguez, L.A.2    Cantero, O.F.3    Logan, R.4    Hernán, M.A.5
  • 78
    • 0141870148 scopus 로고    scopus 로고
    • Evaluating non-randomised intervention studies
    • Deeks, J.J. et al. Evaluating non-randomised intervention studies. Health Technol. Assess. 7, 1–173 (2003).
    • (2003) Health Technol. Assess. , vol.7 , pp. 1-173
    • Deeks, J.J.1


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