Generalizing results of randomized trials to clinical practice: Reliability and cautions

Clinical Trials

Volumn 3, Issue 6, 2006, Pages 508-512

  Flather, Marcus ^a,b,d   Delahunty, Nicola ^a   Collinson, Julian ^c  

^a ROYAL BROMPTON HOSPITAL   (United Kingdom)

^b NATIONAL HEART AND LUNG INSTITUTE   (United Kingdom)

^c CHELSEA AND WESTMINSTER HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^d ROYAL BROMPTON AND HAREFIELD NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

HUMANS; PATIENT COMPLIANCE; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN;

EID: 55249107149     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774506073464     Document Type: Conference Paper

References (22)

1. Horton R. Common sense and figures: The rhetoric of validity in medicine (Bradford Hill Memorial Lecture 1999). Stat Med 2000; 19: 3149-3164.
2. Seale JP, Gebski VJ, Keech AC. Generalizing the results of trials to clinical practice. Medical Journal of Australia 2004; 181: 558-560.
3. Bang H, Davis CE. On estimating treatment effects under non-compliance in randomized clinical trials: Are intent-to-treat or instrumental variables analyses perfect solutions? Stat Med. e-pub Aug 2006.
4. Kostis JB, Packer M, Black HR, Schmieder R, Henry D, Levy E. Omapatrilat and enalapril in patients with hypertension: The Omapatrilat Cardiovascular Treatment vs. Enalapril (OCTAVE) trial. Am J Hypertens 2004; 17: 103-111.
5. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. Br Med J 1999; 319: 670-674.
6. Buyse M, George SL, Evans S et al. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. Stat Med 1999; 18: 3435-3451.
7. Bartlett C, Doyal L, Ebrahim S et al. The causes and effects of socio-demographic exclusions from clinical trials. Health Technol Assess 2005; 9: 1-168.
8. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003; 290: 1624-1632.
9. Godwin M, Ruhland L, Casson I et al. Pragmatic controlled clinical trials in primary care: The struggle between external and internal validity. BMC Medical Research Methodology 2003; 3: 28-28.
10. Iwasaki M, Yamamoto S, Otani T et al. Japan Public Health Center-based Prospective Study Group. Generalizability of relative risk estimates from a well-defined population to a general population, Japan Public Health Center-based Prospective Study Group. Eur J Epidemiol 2006; 21: 253-262.
11. Zimmerman M, Chelminski I, Posternak MA. Generalizability of antidepressant efficacy trials: Differences between depressed psychiatric outpatients who would or would not qualify for an efficacy trial. Am J Psychiatry 2005; 162: 1370-1372.
12. Yessaian A, Mendivil AA, Brewster WR. Population characteristics in cervical cancer trials: Search for external validity. Am J Obstet Gynecol 2005; 192: 407-413.
13. Bahit MC, Cannon CP, Antman EM et al.; TIMI 9 Trial and TIMI 9 Registry. 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: 109-117.
14. Baker SG, Kramer BS. Randomized trials, generalizability, and meta-analysis: Graphical insights for binary outcomes. BMC Med Res Methodol 2003; 3: 10-10.
15. Rothwell PM, Mehta Z, Howard SC, Gutnikov SA, Warlow CP. From subgroups to individuals: General principles and the example of carotid endarterectomy. Lancet 2005; 365: 256-265.
16. Rothwell PM, Warlow CP, on behalf of the European Carotid Surgery Trialists' Collaborative Group. Prediction of benefit from carotid endarterectomy in individual patients: A risk modelling study. Lancet 1999; 353: 2105-2110.
17. Terrin N, Schmid CH, Griffith JL, D'Agostino RB, Selker HP. External validity of predictive models: A comparison of logistic regression, classification trees, and neural networks. J Clin Epidemiol 2003; 56: 721-729.
18. Lund E, Kumle M, Braaten T et al. External validity in a population-based national prospective study-the Norwegian Women and Cancer Study (NOWAC). Cancer Causes Control 2003; 14: 1001-1008.
19. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet 1996; 348: 1329-1339.
20. Caro JJ, Migliaccio-Walle K. Generalizing the results of clinical trials to apractice: The example of clopidogrel therapy for the prevention of vascular events. CAPRA (CAPRIE Actual Practice Rates Analysis) Study Group. Clopidogrel versus aspirin in patients at risk of ischaemic events. Am J Med 1999; 107: 568-572.
21. Elting LS, Cooksley C, Bekele BN et al. Generalizability of cancer clinical trial results: Prognostic differences between participants and non-participants. Cancer 2006; 106: 2452-2458.
22. Chen ZM, Jiang LX, Chen YP et al. COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: Randomised placebo-controlled trial. Lancet 2005; 366: 1607-1621.