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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?”. Lancet. 2005;365:82–93.
Article
PubMed
Google Scholar
Singal AG, Higgins PDR, Waljee AK. A primer on effectiveness and efficacy trials. Clin Trans Gastroenterol. 2014;5:e45.
Article
CAS
Google Scholar
Rothwell PM. Factors that can affect the external validity of randomised controlled trials. PLoS Clin Trials. 2006;1:e9.
Article
PubMed
PubMed Central
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
PubMed
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
Arksey H, O’Malley L. Scoping studies: towards a methodological framework. Int J Soc Res Methodol. 2005;8:19–32.
Article
Google Scholar
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.
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
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.
Article
PubMed
PubMed Central
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
Khan AY, Preskorn SH, Baker B. Effect of study criteria on recruitment and generalizability of the results. J Clin Psychopharmacol. 2005;25:271–5.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
Melloni C, Berger JS, Wang TY, Gunes F, Stebbins A, Pieper KS, et al. Representation of women in randomized clinical trials of cardiovascular disease prevention. Circ Cardiovasc Qual Outcomes. 2010;3:135–42.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
Steg PG, López-Sendón J, Lopez De Sa E, Goodman SG, Gore JM, Anderson FA, et al. External validity of clinical trials in acute myocardial infarction. Arch Intern Med. 2007;167:68–73.
Article
PubMed
Google Scholar
Storosum JG, Fouwels A, Gispen-de Wied CC, Wohlfarth T, Van Zwieten BJ, van den Brink W. How real are patients in placebo-controlled studies of acute manic episode? Eur Neuropsychopharmacol. 2004;14:319–23.
Article
CAS
PubMed
Google Scholar
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.
Article
PubMed
PubMed Central
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
PubMed
Google Scholar
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.
Article
PubMed
PubMed Central
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
Zetin M, Hoepner CT. Relevance of exclusion criteria in antidepressant clinical trials: a replication study. J Clin Psychopharmacol. 2007;27:295–301.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
PubMed Central
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
PubMed Central
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
Talamo A, Baldessarini RJ, Centorrino F. Comparison of mania patients suitable for treatment trials vs clinical treatment. Hum Psychopharmacol. 2008;23:447–54.
Article
PubMed
PubMed Central
Google Scholar
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.
Article
PubMed
Google Scholar
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.
Article
PubMed
Google Scholar
Yessaian A, Mendivil AA, Brewster WR. Population characteristics in cervical cancer trials: search for external validity. Am J Obstet Gynecol. 2005;192:407–13.
Article
PubMed
Google Scholar
Garfield FB, Garfield JM. Clinical judgment and clinical practice guidelines. Int J Technol Assess Health Care. 2000;16:1050–60.
Article
CAS
PubMed
Google Scholar
Velasco E. Inclusion criteria. In: Salkind NJ, editor. Encyclopedia of research, volume 1. Thousand Oaks: SAGE Publications, Inc; 2010. p. 589–91.
Google Scholar
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.
Google Scholar
Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13:217–24.
PubMed
PubMed Central
Google Scholar
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.
Article
PubMed
Google Scholar
Sutton AJ, Higgins JP. Recent developments in meta-analysis. Stat Med. 2008;27:625–50.
Article
PubMed
Google Scholar
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.
Article
CAS
PubMed
Google Scholar
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.
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.
Article
Google Scholar
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.
Article
PubMed
PubMed Central
Google Scholar
Silverman SL. From randomized controlled trials to observational studies. Am J Med. 2009;122:114–20.
Article
PubMed
Google Scholar
Yang W, Zilov A, Soewondo P, Bech OM, Sekkal F, Home PD. Observational studies: going beyond the boundaries of randomized controlled trial. Diabetes Res Clin Pract. 2010;88 suppl 1:S3–9.
Article
PubMed
Google Scholar