메뉴 건너뛰기




Volumn 16, Issue 1, 2015, Pages

A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results

Author keywords

Cardiology; External validity; Generalizability; Literature review; Mental health; Oncology; Randomized controlled trial; Real world patients

Indexed keywords

BIBLIOGRAPHIC DATABASE; CARDIOLOGY; CLINICAL DECISION MAKING; CLINICAL RESEARCH; COMORBIDITY; DEMOGRAPHY; EVIDENCE BASED MEDICINE; EXTERNAL VALIDITY; HUMAN; INFORMATION PROCESSING; INTERNAL VALIDITY; MENTAL HEALTH; ONCOLOGY; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SOCIOECONOMICS; STUDY DESIGN; MENTAL HEALTH SERVICE; METHODOLOGY; PROCEDURES; REPRODUCIBILITY; STATISTICAL ANALYSIS; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME;

EID: 84946227382     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-1023-4     Document Type: Review
Times cited : (621)

References (78)
  • 1
    • 77953395873 scopus 로고    scopus 로고
    • CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials
    • Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726-32.
    • (2010) Ann Intern Med , vol.152 , pp. 726-732
    • Schulz, K.F.1    Altman, D.G.2    Moher, D.3
  • 2
    • 33947498821 scopus 로고    scopus 로고
    • Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review
    • Van Spall HG, Toren A, Kiss A, Fowler RA, et al. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA. 2007;297:1233-40.
    • (2007) JAMA , vol.297 , pp. 1233-1240
    • Spall, H.G.1    Toren, A.2    Kiss, A.3    Fowler, R.A.4
  • 3
    • 11444261579 scopus 로고    scopus 로고
    • External validity of randomised controlled trials: "to whom do the results of this trial apply?"
    • Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet. 2005;365:82-93.
    • (2005) Lancet , vol.365 , pp. 82-93
    • Rothwell, P.M.1
  • 5
    • 34247530125 scopus 로고    scopus 로고
    • Factors that can affect the external validity of randomised controlled trials
    • Rothwell PM. Factors that can affect the external validity of randomised controlled trials. PLoS Clin Trials. 2006;1:e9.
    • (2006) PLoS Clin Trials , vol.1 , pp. e9
    • Rothwell, P.M.1
  • 6
    • 53449094159 scopus 로고    scopus 로고
    • Beyond the randomized clinical trial: the role of effectiveness studies in evaluating cardiovascular therapies
    • Nallamothu BK, Hayward RA, Bates ER. Beyond the randomized clinical trial: the role of effectiveness studies in evaluating cardiovascular therapies. Circulation. 2008;118:1294-303.
    • (2008) Circulation , vol.118 , pp. 1294-1303
    • Nallamothu, B.K.1    Hayward, R.A.2    Bates, E.R.3
  • 7
    • 84888615218 scopus 로고    scopus 로고
    • The necessity for clinical reasoning in the era of evidence-based medicine
    • Sniderman AD, LaChapelle KJ, Rachon NA, Furberg CD, et al. The necessity for clinical reasoning in the era of evidence-based medicine. Mayo Clin Proc. 2013;88:1108-14.
    • (2013) Mayo Clin Proc , vol.88 , pp. 1108-1114
    • Sniderman, A.D.1    LaChapelle, K.J.2    Rachon, N.A.3    Furberg, C.D.4
  • 8
    • 3242753497 scopus 로고    scopus 로고
    • The potential role of community-based registries to complement the limited applicability of clinical trial results to the community setting: heart failure as an example
    • Franciosa JA. The potential role of community-based registries to complement the limited applicability of clinical trial results to the community setting: heart failure as an example. Am J Manag Care. 2004;10:487-92.
    • (2004) Am J Manag Care , vol.10 , pp. 487-492
    • Franciosa, J.A.1
  • 9
    • 84874174557 scopus 로고    scopus 로고
    • External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?
    • Saunders C, Byrne CD, Guthrie B, Lindsay RS, McKnight JA, Sattar N, et al. External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants? Diabet Med. 2013;30:300-8.
    • (2013) Diabet Med , vol.30 , pp. 300-308
    • Saunders, C.1    Byrne, C.D.2    Guthrie, B.3    Lindsay, R.S.4    McKnight, J.A.5    Sattar, N.6
  • 10
    • 33644990599 scopus 로고    scopus 로고
    • Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: results from the Euro Heart Survey on Coronary Revascularization
    • Hordijk-Trion M, Lenzen M, Wijns W, De Jagere P, Simmons ML, Scholte Op Reimer WJM, et al. Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: results from the Euro Heart Survey on Coronary Revascularization. Eur Heart J. 2006;27:671-8.
    • (2006) Eur Heart J , vol.27 , pp. 671-678
    • Hordijk-Trion, M.1    Lenzen, M.2    Wijns, W.3    Jagere, P.4    Simmons, M.L.5    Scholte Op Reimer, W.J.M.6
  • 11
    • 68749089916 scopus 로고    scopus 로고
    • Patients enrolled in large randomized clinical trials of antiplatelet treatment for prevention after transient ischemic attack or ischemic stroke are not representative of patients in clinical practice: the Netherlands Stroke Survey
    • Maasland L, Van Oostenbrugge RJ, Franke CF, Scholte Op Reimer WJM, Koudstaal PJ, Dippel DWJ, et al. Patients enrolled in large randomized clinical trials of antiplatelet treatment for prevention after transient ischemic attack or ischemic stroke are not representative of patients in clinical practice: the Netherlands Stroke Survey. Stroke. 2009;40:2662-8.
    • (2009) Stroke , vol.40 , pp. 2662-2668
    • Maasland, L.1    Oostenbrugge, R.J.2    Franke, C.F.3    Scholte Op Reimer, W.J.M.4    Koudstaal, P.J.5    Dippel, D.W.J.6
  • 12
    • 33947579183 scopus 로고    scopus 로고
    • External validity of randomised controlled trials in asthma: to whom do the results of the trials apply?
    • Travers J, Marsh S, Williams M, Weatherall M, Caldwekk B, Shirtcliffe P, et al. External validity of randomised controlled trials in asthma: to whom do the results of the trials apply? Thorax. 2007;62:219-23.
    • (2007) Thorax , vol.62 , pp. 219-223
    • Travers, J.1    Marsh, S.2    Williams, M.3    Weatherall, M.4    Caldwekk, B.5    Shirtcliffe, P.6
  • 13
    • 43549123796 scopus 로고    scopus 로고
    • Assessment of unmet needs and the lack of generalizability in the design of randomized controlled trials for scleroderma treatment
    • Villela R, Yuen SY, Pope JE, Baron M. Assessment of unmet needs and the lack of generalizability in the design of randomized controlled trials for scleroderma treatment. Arthritis Rheum. 2008;59:706-13.
    • (2008) Arthritis Rheum , vol.59 , pp. 706-713
    • Villela, R.1    Yuen, S.Y.2    Pope, J.E.3    Baron, M.4
  • 14
    • 14644388070 scopus 로고    scopus 로고
    • Scoping studies: towards a methodological framework
    • Arksey H, O'Malley L. Scoping studies: towards a methodological framework. Int J Soc Res Methodol. 2005;8:19-32.
    • (2005) Int J Soc Res Methodol , vol.8 , pp. 19-32
    • Arksey, H.1    O'Malley, L.2
  • 15
    • 0037833740 scopus 로고    scopus 로고
    • Patients with chronic heart failure encountered in daily clinical practice are different from the "typical" patient enrolled in therapeutic trials
    • Badano LP, Di Lenarda A, Bellotti P, Albanese MC, Sinagra G, Fioretti PM. Patients with chronic heart failure encountered in daily clinical practice are different from the "typical" patient enrolled in therapeutic trials. Ital Heart J. 2003;4:84-91.
    • (2003) Ital Heart J , vol.4 , pp. 84-91
    • Badano, L.P.1    Lenarda, A.2    Bellotti, P.3    Albanese, M.C.4    Sinagra, G.5    Fioretti, P.M.6
  • 16
    • 0037221346 scopus 로고    scopus 로고
    • Thrombolysis in myocardial infarction. Direct comparison of characteristics, treatment, and outcomes of patients enrolled versus patients not enrolled in a clinical trial at centers participating in the TIMI 9 Trial and TIMI 9 registry
    • Bahit MC, Cannon CP, Antman EM, Murphy SA, Gibson MC, McCabe CH, et al. Thrombolysis in myocardial infarction. Direct comparison of characteristics, treatment, and outcomes of patients enrolled versus patients not enrolled in a clinical trial at centers participating in the TIMI 9 Trial and TIMI 9 registry. Am Heart J. 2003;145:109-17.
    • (2003) Am Heart J , vol.145 , pp. 109-117
    • Bahit, M.C.1    Cannon, C.P.2    Antman, E.M.3    Murphy, S.A.4    Gibson, M.C.5    McCabe, C.H.6
  • 17
    • 5344232735 scopus 로고    scopus 로고
    • Outcome of ST-elevation myocardial infarction treated with thrombolysis in the unselected population is vastly different from samples of eligible patients in a large-scale clinical trial
    • Björklund E, Lindahl B, Stenestrand U, Swahn E, Delborg M, Pehrsson K, et al. Outcome of ST-elevation myocardial infarction treated with thrombolysis in the unselected population is vastly different from samples of eligible patients in a large-scale clinical trial. Am Heart J. 2004;148:566-73.
    • (2004) Am Heart J , vol.148 , pp. 566-573
    • Björklund, E.1    Lindahl, B.2    Stenestrand, U.3    Swahn, E.4    Delborg, M.5    Pehrsson, K.6
  • 18
    • 49649097997 scopus 로고    scopus 로고
    • Generalizability of clinical trial results for major depression to community samples: results from the National Epidemiologic Survey on Alcohol and Related Conditions
    • Blanco C, Olfson M, Goodwin RD, Ogburn E, Liebowitz MR, Nunes EV, et al. Generalizability of clinical trial results for major depression to community samples: results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry. 2008;69:1276-80.
    • (2008) J Clin Psychiatry , vol.69 , pp. 1276-1280
    • Blanco, C.1    Olfson, M.2    Goodwin, R.D.3    Ogburn, E.4    Liebowitz, M.R.5    Nunes, E.V.6
  • 19
    • 38349088605 scopus 로고    scopus 로고
    • Causes of ineligibility in randomized controlled trials and long-term mortality in patients with non-ST-segment elevation acute coronary syndromes
    • Bosch X, Delgado V, Verbal F, Bórquez E, Loma-Osorio P, Díez-Aja S, et al. Causes of ineligibility in randomized controlled trials and long-term mortality in patients with non-ST-segment elevation acute coronary syndromes. Int J Cardiol. 2008;124:86-91.
    • (2008) Int J Cardiol , vol.124 , pp. 86-91
    • Bosch, X.1    Delgado, V.2    Verbal, F.3    Bórquez, E.4    Loma-Osorio, P.5    Díez-Aja, S.6
  • 20
    • 84860462185 scopus 로고    scopus 로고
    • The eligibility of advanced non-small-cell lung cancer patients for targeted therapy clinical trials
    • Clarey J, Kao SC, Clarke SJ, Vardy J. The eligibility of advanced non-small-cell lung cancer patients for targeted therapy clinical trials. Ann Oncol. 2012;23:1229-33.
    • (2012) Ann Oncol , vol.23 , pp. 1229-1233
    • Clarey, J.1    Kao, S.C.2    Clarke, S.J.3    Vardy, J.4
  • 21
    • 62949249321 scopus 로고    scopus 로고
    • Eligibility criteria in heart failure randomized controlled trials: a gap between evidence and clinical practice
    • Costantino G, Rusconi AM, Duca PG, Giorgia Duca P, Guzzetti S, Bossi I, et al. Eligibility criteria in heart failure randomized controlled trials: a gap between evidence and clinical practice. Intern Emerg Med. 2009;4:117-22.
    • (2009) Intern Emerg Med , vol.4 , pp. 117-122
    • Costantino, G.1    Rusconi, A.M.2    Duca, P.G.3    Giorgia Duca, P.4    Guzzetti, S.5    Bossi, I.6
  • 22
    • 38749146467 scopus 로고    scopus 로고
    • Variations between clinical trial participants and Medicare beneficiaries in evidence used for Medicare national coverage decisions
    • Dhruva SS, Redberg RF. Variations between clinical trial participants and Medicare beneficiaries in evidence used for Medicare national coverage decisions. Arch Intern Med. 2008;168:136-40.
    • (2008) Arch Intern Med , vol.168 , pp. 136-140
    • Dhruva, S.S.1    Redberg, R.F.2
  • 23
    • 33646872630 scopus 로고    scopus 로고
    • Generalizability of cancer clinical trial results: prognostic differences between participants and nonparticipants
    • Elting LS, Cooksley C, Bekele BN, Frumovitz M, Avritscher EBC, Sun C, et al. Generalizability of cancer clinical trial results: prognostic differences between participants and nonparticipants. Cancer. 2006;106:2452-8.
    • (2006) Cancer , vol.106 , pp. 2452-2458
    • Elting, L.S.1    Cooksley, C.2    Bekele, B.N.3    Frumovitz, M.4    Avritscher, E.B.C.5    Sun, C.6
  • 24
    • 84873647548 scopus 로고    scopus 로고
    • Acute heart failure: perspectives from a randomized trial and a simultaneous registry
    • Ezekowitz JA, Hu J, Delgado D, Hernandez AF, Kaul P, Leader R, et al. Acute heart failure: perspectives from a randomized trial and a simultaneous registry. Circ Heart Fail. 2012;5:735-41.
    • (2012) Circ Heart Fail , vol.5 , pp. 735-741
    • Ezekowitz, J.A.1    Hu, J.2    Delgado, D.3    Hernandez, A.F.4    Kaul, P.5    Leader, R.6
  • 25
    • 78650695919 scopus 로고    scopus 로고
    • Are patients in clinical trials representative of the general population? Dose intensity and toxicities associated with FE100C-D chemotherapy in a non-trial population of node positive breast cancer patients compared with PACS-01 trial group
    • Fraser J, Steele N, Al Zaman A, Yule A. Are patients in clinical trials representative of the general population? Dose intensity and toxicities associated with FE100C-D chemotherapy in a non-trial population of node positive breast cancer patients compared with PACS-01 trial group. Eur J Cancer. 2011;47:215-20.
    • (2011) Eur J Cancer , vol.47 , pp. 215-220
    • Fraser, J.1    Steele, N.2    Al Zaman, A.3    Yule, A.4
  • 26
    • 77956440627 scopus 로고    scopus 로고
    • Trials assessing pharmacotherapeutic management of aggression in psychiatric patients: comparability with clinical practice
    • Goedhard LE, Stolker JJ, Nijman HL, Egberts TCG, Heerdink ER. Trials assessing pharmacotherapeutic management of aggression in psychiatric patients: comparability with clinical practice. Pharmacopsychiatry. 2010;43:205-9.
    • (2010) Pharmacopsychiatry , vol.43 , pp. 205-209
    • Goedhard, L.E.1    Stolker, J.J.2    Nijman, H.L.3    Egberts, T.C.G.4    Heerdink, E.R.5
  • 27
    • 84873206149 scopus 로고    scopus 로고
    • The older the better: are elderly study participants more non-representative? A cross-sectional analysis of clinical trial and observational study samples
    • Golomb BA, Chan VT, Evans MA, Koperski S, White HL, Criqui MH. The older the better: are elderly study participants more non-representative? A cross-sectional analysis of clinical trial and observational study samples. BMJ Open. 2012;2:e000833.
    • (2012) BMJ Open , vol.2 , pp. e000833
    • Golomb, B.A.1    Chan, V.T.2    Evans, M.A.3    Koperski, S.4    White, H.L.5    Criqui, M.H.6
  • 28
    • 84873551510 scopus 로고    scopus 로고
    • Generalizability of clinical trial results for bipolar disorder to community samples: findings from the National Epidemiologic Survey on Alcohol and Related Conditions
    • Hoertel N, Le Strat Y, Lavaud P, Dubertret C, Limosin F. Generalizability of clinical trial results for bipolar disorder to community samples: findings from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry. 2013;74:265-70.
    • (2013) J Clin Psychiatry , vol.74 , pp. 265-270
    • Hoertel, N.1    Strat, Y.2    Lavaud, P.3    Dubertret, C.4    Limosin, F.5
  • 29
    • 78149465907 scopus 로고    scopus 로고
    • Comparison of baseline characteristics, management and outcome of patients with non-ST-segment elevation acute coronary syndrome in versus not in clinical trials
    • Hutchinson-Jaffe AB, Goodman SG, Yan RT, Wald R, Elbarouni B, Rose B, et al. Comparison of baseline characteristics, management and outcome of patients with non-ST-segment elevation acute coronary syndrome in versus not in clinical trials. Am J Cardiol. 2010;106:1389-96.
    • (2010) Am J Cardiol , vol.106 , pp. 1389-1396
    • Hutchinson-Jaffe, A.B.1    Goodman, S.G.2    Yan, R.T.3    Wald, R.4    Elbarouni, B.5    Rose, B.6
  • 30
    • 33645346222 scopus 로고    scopus 로고
    • Increasing underrepresentation of elderly patients with advanced colorectal or non-small-cell lung cancer in chemotherapy trials
    • Jennens RR, Giles GG, Fox RM. Increasing underrepresentation of elderly patients with advanced colorectal or non-small-cell lung cancer in chemotherapy trials. Intern Med J. 2006;36:216-20.
    • (2006) Intern Med J , vol.36 , pp. 216-220
    • Jennens, R.R.1    Giles, G.G.2    Fox, R.M.3
  • 31
    • 64549105746 scopus 로고    scopus 로고
    • Differences between clinical trial participants and patients in a population-based registry: the German Rectal Cancer Study vs the Rostock Cancer Registry
    • Kalata P, Martus P, Zettl H, Rödel C, Hohenberger W, Raab R, et al. Differences between clinical trial participants and patients in a population-based registry: the German Rectal Cancer Study vs the Rostock Cancer Registry. Dis Colon Rectum. 2009;52:425-37.
    • (2009) Dis Colon Rectum , vol.52 , pp. 425-437
    • Kalata, P.1    Martus, P.2    Zettl, H.3    Rödel, C.4    Hohenberger, W.5    Raab, R.6
  • 32
    • 0141717217 scopus 로고    scopus 로고
    • How many subjects with major depressive disorder meet eligibility requirements of an antidepressant efficacy trial?
    • Keitner GI, Posternak MA, Ryan CE. How many subjects with major depressive disorder meet eligibility requirements of an antidepressant efficacy trial? J Clin Psychiatry. 2003;64:1091-3.
    • (2003) J Clin Psychiatry , vol.64 , pp. 1091-1093
    • Keitner, G.I.1    Posternak, M.A.2    Ryan, C.E.3
  • 33
    • 18844446242 scopus 로고    scopus 로고
    • Effect of study criteria on recruitment and generalizability of the results
    • Khan AY, Preskorn SH, Baker B. Effect of study criteria on recruitment and generalizability of the results. J Clin Psychopharmacol. 2005;25:271-5.
    • (2005) J Clin Psychopharmacol , vol.25 , pp. 271-275
    • Khan, A.Y.1    Preskorn, S.H.2    Baker, B.3
  • 34
    • 70349626033 scopus 로고    scopus 로고
    • Clinical benefit of early reperfusion therapy in patients with ST-elevation myocardial infarction usually excluded from randomized clinical trials (results from the Maximal Individual Therapy in Acute Myocardial Infarction Plus [MITRA Plus] registry)
    • Koeth O, Zahn R, Gitt AK, Bauer T, Juenger C, Senges J, et al. Clinical benefit of early reperfusion therapy in patients with ST-elevation myocardial infarction usually excluded from randomized clinical trials (results from the Maximal Individual Therapy in Acute Myocardial Infarction Plus [MITRA Plus] registry). Am J Cardiol. 2009;104:1074-7.
    • (2009) Am J Cardiol , vol.104 , pp. 1074-1077
    • Koeth, O.1    Zahn, R.2    Gitt, A.K.3    Bauer, T.4    Juenger, C.5    Senges, J.6
  • 35
    • 28544436279 scopus 로고    scopus 로고
    • Under-utilization of evidence-based drug treatment in patients with heart failure is only partially explained by dissimilarity to patients enrolled in landmark trials: a report from the Euro Heart Survey on Heart Failure
    • Lenzen MJ, Boersma E, Scholte Op Reimer WJM, Balk AHMM, Komajda M, Swedberg K, et al. Under-utilization of evidence-based drug treatment in patients with heart failure is only partially explained by dissimilarity to patients enrolled in landmark trials: a report from the Euro Heart Survey on Heart Failure. Eur Heart J. 2005;26:2706-13.
    • (2005) Eur Heart J , vol.26 , pp. 2706-2713
    • Lenzen, M.J.1    Boersma, E.2    Scholte Op Reimer, W.J.M.3    Balk, A.H.M.M.4    Komajda, M.5    Swedberg, K.6
  • 36
    • 0042991391 scopus 로고    scopus 로고
    • Most hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure
    • Masoudi FA, Havranek EP, Wolfe P, Gross CP, Rathore SS, Steiner JF, et al. Most hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure. Am Heart J. 2003;146:250-7.
    • (2003) Am Heart J , vol.146 , pp. 250-257
    • Masoudi, F.A.1    Havranek, E.P.2    Wolfe, P.3    Gross, C.P.4    Rathore, S.S.5    Steiner, J.F.6
  • 38
    • 0642373288 scopus 로고    scopus 로고
    • Assessment of differences in patient populations selected for excluded from participation in clinical phase III acute myelogenous leukemia trials
    • Mengis C, Aebi S, Tobler A, Dähler W, Fey MF. Assessment of differences in patient populations selected for excluded from participation in clinical phase III acute myelogenous leukemia trials. J Clin Oncol. 2003;21:3933-9.
    • (2003) J Clin Oncol , vol.21 , pp. 3933-3939
    • Mengis, C.1    Aebi, S.2    Tobler, A.3    Dähler, W.4    Fey, M.F.5
  • 39
    • 43049111427 scopus 로고    scopus 로고
    • Restrictive eligibility limits access to newer therapies in non-small-cell lung cancer: the implications of Eastern Cooperative Oncology Group 4599
    • Somer RA, Sherman E, Langer CJ. Restrictive eligibility limits access to newer therapies in non-small-cell lung cancer: the implications of Eastern Cooperative Oncology Group 4599. Clin Lung Cancer. 2008;9:102-5.
    • (2008) Clin Lung Cancer , vol.9 , pp. 102-105
    • Somer, R.A.1    Sherman, E.2    Langer, C.J.3
  • 42
    • 78650500542 scopus 로고    scopus 로고
    • Representativeness of participants in a clinical trial for attention-deficit/hyperactivity disorder? Comparison with adults from a large observational study
    • Surman CB, Monuteaux MC, Petty CR, Faraone SV, Spencer TJ, Chu NF, et al. Representativeness of participants in a clinical trial for attention-deficit/hyperactivity disorder? Comparison with adults from a large observational study. J Clin Psychiatry. 2010;71:1612-6.
    • (2010) J Clin Psychiatry , vol.71 , pp. 1612-1616
    • Surman, C.B.1    Monuteaux, M.C.2    Petty, C.R.3    Faraone, S.V.4    Spencer, T.J.5    Chu, N.F.6
  • 43
    • 77957137408 scopus 로고    scopus 로고
    • Are patients with Hodgkin lymphoma and high-grade non-Hodgkin lymphoma in clinical therapy optimization protocols representative of these groups of patients in Germany?
    • Terschüren C, Gierer S, Brillant C, Paulus U, Löffler M, Hoffmann W. Are patients with Hodgkin lymphoma and high-grade non-Hodgkin lymphoma in clinical therapy optimization protocols representative of these groups of patients in Germany? Ann Oncol. 2010;21:2045-51.
    • (2010) Ann Oncol , vol.21 , pp. 2045-2051
    • Terschüren, C.1    Gierer, S.2    Brillant, C.3    Paulus, U.4    Löffler, M.5    Hoffmann, W.6
  • 44
    • 33847684287 scopus 로고    scopus 로고
    • Hypertension patients participating in trials differ in many aspects from patients treated in general practices
    • Uijen AA, Bakx JC, Mokkink HG, Van Weel C. Hypertension patients participating in trials differ in many aspects from patients treated in general practices. J Clin Epidemiol. 2007;60:330-5.
    • (2007) J Clin Epidemiol , vol.60 , pp. 330-335
    • Uijen, A.A.1    Bakx, J.C.2    Mokkink, H.G.3    Weel, C.4
  • 45
    • 84902281606 scopus 로고    scopus 로고
    • Cetuximab in locally advanced squamous cell carcinoma of the head and neck: generalizability of EMR 062202-006 trial results
    • van der Linden N, Van Gils CW, Pescott CP, Buter J, Uyl-de Groot CA. Cetuximab in locally advanced squamous cell carcinoma of the head and neck: generalizability of EMR 062202-006 trial results. Eur Arch Otorhinolaryngol. 2014;271:1673-8.
    • (2014) Eur Arch Otorhinolaryngol , vol.271 , pp. 1673-1678
    • Linden, N.1    Gils, C.W.2    Pescott, C.P.3    Buter, J.4    Uyl-de Groot, C.A.5
  • 46
    • 66049091608 scopus 로고    scopus 로고
    • Eligibility of patients with advanced non-small cell lung cancer for phase III chemotherapy trials
    • Vardy J, Dadasovich R, Beale P, Boyer M, Clarke SJ. Eligibility of patients with advanced non-small cell lung cancer for phase III chemotherapy trials. BMC Cancer. 2009;9:130.
    • (2009) BMC Cancer , vol.9 , pp. 130
    • Vardy, J.1    Dadasovich, R.2    Beale, P.3    Boyer, M.4    Clarke, S.J.5
  • 47
    • 66149184436 scopus 로고    scopus 로고
    • Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D report
    • Wisniewski SR, Rush AJ, Nierenberg AA, Gaynes BN, Warden D, Luther JF, et al. Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D report. Am J Psychiatry. 2009;166:599-607.
    • (2009) Am J Psychiatry , vol.166 , pp. 599-607
    • Wisniewski, S.R.1    Rush, A.J.2    Nierenberg, A.A.3    Gaynes, B.N.4    Warden, D.5    Luther, J.F.6
  • 48
    • 84875221675 scopus 로고    scopus 로고
    • Characteristics of advanced cancer patients with cancer-related fatigue enrolled in clinical trials and patients referred to outpatient palliative care clinics
    • Yennurajalingam S, Kang JH, Cheng HY, Chisholm GB, Kwon JH, Palla SL, et al. Characteristics of advanced cancer patients with cancer-related fatigue enrolled in clinical trials and patients referred to outpatient palliative care clinics. J Pain Symptom Manage. 2013;45:534-41.
    • (2013) J Pain Symptom Manage , vol.45 , pp. 534-541
    • Yennurajalingam, S.1    Kang, J.H.2    Cheng, H.Y.3    Chisholm, G.B.4    Kwon, J.H.5    Palla, S.L.6
  • 49
    • 11244278062 scopus 로고    scopus 로고
    • Challenges to evidence-based medicine: a comparison of patients and treatments in randomized controlled trials with patients and treatments in a practice research network
    • Zarin DA, Young JL, West JC. Challenges to evidence-based medicine: a comparison of patients and treatments in randomized controlled trials with patients and treatments in a practice research network. Soc Psychiatry Psychiatr Epidemiol. 2005;40:27-35.
    • (2005) Soc Psychiatry Psychiatr Epidemiol , vol.40 , pp. 27-35
    • Zarin, D.A.1    Young, J.L.2    West, J.C.3
  • 50
    • 34248585038 scopus 로고    scopus 로고
    • Relevance of exclusion criteria in antidepressant clinical trials: a replication study
    • Zetin M, Hoepner CT. Relevance of exclusion criteria in antidepressant clinical trials: a replication study. J Clin Psychopharmacol. 2007;27:295-301.
    • (2007) J Clin Psychopharmacol , vol.27 , pp. 295-301
    • Zetin, M.1    Hoepner, C.T.2
  • 51
    • 1342325372 scopus 로고    scopus 로고
    • Exclusion criteria used in antidepressant efficacy trials: consistency across studies and representativeness of samples included
    • Zimmerman M, Chelminski I, Posternak MA. Exclusion criteria used in antidepressant efficacy trials: consistency across studies and representativeness of samples included. J Nerv Ment Dis. 2004;192:87-94.
    • (2004) J Nerv Ment Dis , vol.192 , pp. 87-94
    • Zimmerman, M.1    Chelminski, I.2    Posternak, M.A.3
  • 52
    • 77249113747 scopus 로고    scopus 로고
    • Analysis of Maryland cancer patient participation in National Cancer Institute-supported cancer treatment clinical trials
    • Baquet CR, Ellison GL, Mishra SI. Analysis of Maryland cancer patient participation in National Cancer Institute-supported cancer treatment clinical trials. J Health Care Poor Underserved. 2009;20(2 Suppl):120-34.
    • (2009) J Health Care Poor Underserved , vol.20 , Issue.2 , pp. 120-134
    • Baquet, C.R.1    Ellison, G.L.2    Mishra, S.I.3
  • 53
    • 0037219097 scopus 로고    scopus 로고
    • Enoxaparin in unstable angina patients who would have been excluded from randomized pivotal trials
    • Collet JP, Montalescot G, Fine E, Golmard J-L, Dalby M, Choussat R, et al. Enoxaparin in unstable angina patients who would have been excluded from randomized pivotal trials. J Am Coll Cardiol. 2003;41:8-14.
    • (2003) J Am Coll Cardiol , vol.41 , pp. 8-14
    • Collet, J.P.1    Montalescot, G.2    Fine, E.3    Golmard, J.-L.4    Dalby, M.5    Choussat, R.6
  • 54
    • 84867545398 scopus 로고    scopus 로고
    • Eligibility criteria in randomized phase II and III adjuvant and neoadjuvant breast cancer trials: not a significant barrier to enrollment
    • Filion M, Forget G, Brochu O, Provencher L, Desbien SC, Doyle C, et al. Eligibility criteria in randomized phase II and III adjuvant and neoadjuvant breast cancer trials: not a significant barrier to enrollment. Clin Trials. 2012;9:652-9.
    • (2012) Clin Trials , vol.9 , pp. 652-659
    • Filion, M.1    Forget, G.2    Brochu, O.3    Provencher, L.4    Desbien, S.C.5    Doyle, C.6
  • 55
    • 33645541338 scopus 로고    scopus 로고
    • Randomized controlled trials: do they have external validity for patients with multiple comorbidities?
    • Fortin M, Dionne J, Pinho G, Gignac J, Almirall J, Lapointe L. Randomized controlled trials: do they have external validity for patients with multiple comorbidities? Ann Fam Med. 2006;4:104-8.
    • (2006) Ann Fam Med , vol.4 , pp. 104-108
    • Fortin, M.1    Dionne, J.2    Pinho, G.3    Gignac, J.4    Almirall, J.5    Lapointe, L.6
  • 56
    • 0242468107 scopus 로고    scopus 로고
    • Is there evidence of implicit exclusion criteria for elderly subjects in randomized trials? Evidence from the GUSTO-1 study
    • Krumholz HM, Gross CP, Peterson ED, Barron HV, Radford MJ, Parsons LS, et al. Is there evidence of implicit exclusion criteria for elderly subjects in randomized trials? Evidence from the GUSTO-1 study. Am Heart J. 2003;146:839-47.
    • (2003) Am Heart J , vol.146 , pp. 839-847
    • Krumholz, H.M.1    Gross, C.P.2    Peterson, E.D.3    Barron, H.V.4    Radford, M.J.5    Parsons, L.S.6
  • 57
    • 67650097020 scopus 로고    scopus 로고
    • A comparison of depressed patients in randomized vs nonrandomized trials of antidepressant medication and psychotherapy
    • Kushner SC, Quilty LC, McBride C, Bagby RM. A comparison of depressed patients in randomized vs nonrandomized trials of antidepressant medication and psychotherapy. Depress Anxiety. 2009;26:666-73.
    • (2009) Depress Anxiety , vol.26 , pp. 666-673
    • Kushner, S.C.1    Quilty, L.C.2    McBride, C.3    Bagby, R.M.4
  • 58
    • 84877352669 scopus 로고    scopus 로고
    • Comparison of treatment outcome in metastatic colorectal cancer patients included in a clinical trial versus daily practice in The Netherlands
    • Mol L, Koopman M, Van Gils CW, Ottevanger PB, Punt CJA. Comparison of treatment outcome in metastatic colorectal cancer patients included in a clinical trial versus daily practice in The Netherlands. Acta Oncol. 2013;52:950-5.
    • (2013) Acta Oncol , vol.52 , pp. 950-955
    • Mol, L.1    Koopman, M.2    Gils, C.W.3    Ottevanger, P.B.4    Punt, C.J.A.5
  • 59
    • 0037410334 scopus 로고    scopus 로고
    • Are patients enrolled in first episode psychosis drug trials representative of patients treated in routine clinical practice?
    • Rabinowitz J, Bromet EJ, Davidson M. Are patients enrolled in first episode psychosis drug trials representative of patients treated in routine clinical practice? Schizophr Res. 2003;61:149-55.
    • (2003) Schizophr Res , vol.61 , pp. 149-155
    • Rabinowitz, J.1    Bromet, E.J.2    Davidson, M.3
  • 60
    • 17644371975 scopus 로고    scopus 로고
    • How representative of everyday clinical populations are schizophrenia patients enrolled in clinical trials?
    • Riedel M, Strassnig M, Müller N, Zwack P, Möller H-J. How representative of everyday clinical populations are schizophrenia patients enrolled in clinical trials? Eur Arch Psychiatry Clin Neurosci. 2005;255:143-8.
    • (2005) Eur Arch Psychiatry Clin Neurosci , vol.255 , pp. 143-148
    • Riedel, M.1    Strassnig, M.2    Müller, N.3    Zwack, P.4    Möller, H.-J.5
  • 61
    • 78649776463 scopus 로고    scopus 로고
    • Do efficacy and effectiveness samples differ in antidepressant treatment outcome? An analysis of eligibility criteria in randomized controlled trials
    • Seemüller F, Möller HJ, Obermeier M, Adli M, Bauer M, Kronmüller K, et al. Do efficacy and effectiveness samples differ in antidepressant treatment outcome? An analysis of eligibility criteria in randomized controlled trials. J Clin Psychiatry. 2010;71:1425-33.
    • (2010) J Clin Psychiatry , vol.71 , pp. 1425-1433
    • Seemüller, F.1    Möller, H.J.2    Obermeier, M.3    Adli, M.4    Bauer, M.5    Kronmüller, K.6
  • 62
    • 34250645006 scopus 로고    scopus 로고
    • Global outcomes of ST-elevation myocardial infarction: comparisons of the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction study 25 (ExTRACT-TIMI 25) registry and trial
    • Steinberg BA, Moghbeli N, Buros J, Ruda M, Parkhomenko A, Raju BS, et al. Global outcomes of ST-elevation myocardial infarction: comparisons of the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction study 25 (ExTRACT-TIMI 25) registry and trial. Am Heart J. 2007;154:54-61.
    • (2007) Am Heart J , vol.154 , pp. 54-61
    • Steinberg, B.A.1    Moghbeli, N.2    Buros, J.3    Ruda, M.4    Parkhomenko, A.5    Raju, B.S.6
  • 63
    • 51049111989 scopus 로고    scopus 로고
    • Comparison of mania patients suitable for treatment trials vs clinical treatment
    • Talamo A, Baldessarini RJ, Centorrino F. Comparison of mania patients suitable for treatment trials vs clinical treatment. Hum Psychopharmacol. 2008;23:447-54.
    • (2008) Hum Psychopharmacol , vol.23 , pp. 447-454
    • Talamo, A.1    Baldessarini, R.J.2    Centorrino, F.3
  • 64
    • 79958796188 scopus 로고    scopus 로고
    • The generalizability of antidepressant efficacy trials to routine psychiatric out-patient practice
    • van der Lem R, van der Wee NJ, Van Veen T, Zitman FG. The generalizability of antidepressant efficacy trials to routine psychiatric out-patient practice. Psychol Med. 2011;41:1353-63.
    • (2011) Psychol Med , vol.41 , pp. 1353-1363
    • Lem, R.1    Wee, N.J.2    Veen, T.3    Zitman, F.G.4
  • 65
    • 79551516516 scopus 로고    scopus 로고
    • The generalizability of participants in Veterans Affairs Cooperative Studies Program 474, a multi-site randomized cardiac bypass surgery trial
    • Wagner TH, Holman W, Lee K, Sethi G, Ananth L, Thai H, et al. The generalizability of participants in Veterans Affairs Cooperative Studies Program 474, a multi-site randomized cardiac bypass surgery trial. Contemp Clin Trials. 2011;32:260-6.
    • (2011) Contemp Clin Trials , vol.32 , pp. 260-266
    • Wagner, T.H.1    Holman, W.2    Lee, K.3    Sethi, G.4    Ananth, L.5    Thai, H.6
  • 66
    • 13444288189 scopus 로고    scopus 로고
    • Population characteristics in cervical cancer trials: search for external validity
    • Yessaian A, Mendivil AA, Brewster WR. Population characteristics in cervical cancer trials: search for external validity. Am J Obstet Gynecol. 2005;192:407-13.
    • (2005) Am J Obstet Gynecol , vol.192 , pp. 407-413
    • Yessaian, A.1    Mendivil, A.A.2    Brewster, W.R.3
  • 68
    • 84856646231 scopus 로고    scopus 로고
    • Inclusion criteria
    • In: Salkind NJ, editor. Encyclopedia of research. Thousand Oaks: SAGE Publications, Inc.
    • Velasco E. Inclusion criteria. In: Salkind NJ, editor. Encyclopedia of research, volume 1. Thousand Oaks: SAGE Publications, Inc; 2010. p. 589-91.
    • (2010) , vol.1 , pp. 589-591
    • Velasco, E.1
  • 69
    • 84946231294 scopus 로고    scopus 로고
    • Chapter 9, Treatment. In: Fletcher R, Fletcher SW, Fletcher GS, editors. Clinical epidemiology: the essentials. 5th ed. Baltimore: Wolters Kluwer
    • Fletcher R, Fletcher SW, Fletcher GS. Chapter 9, Treatment. In: Fletcher R, Fletcher SW, Fletcher GS, editors. Clinical epidemiology: the essentials. 5th ed. Baltimore: Wolters Kluwer; 2014. p. 132-52.
    • (2014) , pp. 132-152
    • Fletcher, R.1    Fletcher, S.W.2    Fletcher, G.S.3
  • 70
    • 80052146670 scopus 로고    scopus 로고
    • A pragmatic view on pragmatic trials
    • Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13:217-24.
    • (2011) Dialogues Clin Neurosci , vol.13 , pp. 217-224
    • Patsopoulos, N.A.1
  • 71
    • 84930648211 scopus 로고    scopus 로고
    • The PRECIS-2 tool: designing tools that are fit for purpose
    • Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE. The PRECIS-2 tool: designing tools that are fit for purpose. BMJ. 2015;350:h2147.
    • (2015) BMJ , vol.350 , pp. h2147
    • Loudon, K.1    Treweek, S.2    Sullivan, F.3    Donnan, P.4    Thorpe, K.E.5
  • 72
    • 39549093107 scopus 로고    scopus 로고
    • Recent developments in meta-analysis
    • Sutton AJ, Higgins JP. Recent developments in meta-analysis. Stat Med. 2008;27:625-50.
    • (2008) Stat Med , vol.27 , pp. 625-650
    • Sutton, A.J.1    Higgins, J.P.2
  • 73
    • 0034736553 scopus 로고    scopus 로고
    • Hierarchical models in generalized synthesis of evidence: an example based on studies of breast cancer screening
    • Prevost TC, Abrams KR, Jones DR. Hierarchical models in generalized synthesis of evidence: an example based on studies of breast cancer screening. Stat Med. 2000;19:3359-76.
    • (2000) Stat Med , vol.19 , pp. 3359-3376
    • Prevost, T.C.1    Abrams, K.R.2    Jones, D.R.3
  • 74
    • 0003847504 scopus 로고
    • Cross design synthesis
    • A new strategy for medical effectiveness research. United States Government.
    • United States General Accounting Office. Cross design synthesis. A new strategy for medical effectiveness research. United States Government. 1992. http://www.gao.gov/assets/160/151472.pdf. Accessed 2 Jul 2015.
    • (1992)
  • 75
    • 79952586276 scopus 로고    scopus 로고
    • The use of propensity scores to assess the generalizability of results from randomized trials
    • Stuart EA, Cole SR, Bradshaw CP, Leaf PJ. The use of propensity scores to assess the generalizability of results from randomized trials. JR Statist Soc A. 2011;174:369-86.
    • (2011) JR Statist Soc A , vol.174 , pp. 369-386
    • Stuart, E.A.1    Cole, S.R.2    Bradshaw, C.P.3    Leaf, P.J.4
  • 76
    • 84882244948 scopus 로고    scopus 로고
    • The use of propensity scores and observational data to estimate randomized controlled trial generalizability bias
    • Pressler TR, Kaizar EE. The use of propensity scores and observational data to estimate randomized controlled trial generalizability bias. Stat Med. 2013;32:3552-68.
    • (2013) Stat Med , vol.32 , pp. 3552-3568
    • Pressler, T.R.1    Kaizar, E.E.2
  • 77
    • 58649083487 scopus 로고    scopus 로고
    • From randomized controlled trials to observational studies
    • Silverman SL. From randomized controlled trials to observational studies. Am J Med. 2009;122:114-20.
    • (2009) Am J Med , vol.122 , pp. 114-120
    • Silverman, S.L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.