Inconsistent trial assessments by the national institute for health and clinical excellence and IQWiG: Standards for the performance and interpretation of subgroup analyses are needed

Journal of Clinical Epidemiology

Volumn 63, Issue 12, 2010, Pages 1298-1304

  Hasford, J ^a   Bramlage, P ^b   Koch, G ^c   Lehmacher, W ^d   Einhaupl K ^e   Rothwell, P M ^f  

^a UNIVERSITY OF MUNICH   (Germany)

^b Institute for Cardiovascular Pharmacology and Epidemiology   (Germany)

^c IL   (United States)

^d UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^e CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^f JOHN RADCLIFFE HOSPITAL   (United Kingdom)

Author keywords

Aspirin; Clopidogrel; Heterogeneity; Myocardial infarction; Peripheral arterial disease; Stroke

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL;

CLINICAL ASSESSMENT; CLINICAL PRACTICE; CLINICAL RESEARCH; CLINICAL TRIAL; HEALTH CARE; HEALTH CARE QUALITY; HEART MUSCLE ISCHEMIA; HUMAN; PERFORMANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; STANDARD;

ASPIRIN; CARDIOVASCULAR DISEASES; ENGLAND; EVIDENCE-BASED MEDICINE; GERMANY; HUMANS; INTENTION TO TREAT ANALYSIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; TICLOPIDINE;

EID: 78049249374     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2009.10.009     Document Type: Review

References (18)

1. S. Yusuf, R. Collins, and R. Peto Why do we need some large, simple randomized trials? Stat Med 3 1984 409 422
2. P.M. Rothwell External validity of randomised controlled trials: "to whom do the results of this trial apply?" Lancet 365 2005 82 93
3. P.M. Rothwell Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation Lancet 365 2005 176 186
4. IQWiG. Final report plan for the evaluation: "clopidogrel versus acetyl salicylic acid in the secondary prevention of vascular events". 2006. Available at: http://www.iqwig.de/download/A04-1A-Abschlussbericht- Clopidogrel-versus-ASS-in-der-Sekundaerprophylaxe.pdf. Accessed January 21, 2008.
5. NICE. Clopidogrel and modified-release dipyridamole in the prevention of occlusive vascular events. 2005. Available at: http://www.nice.org.uk/nicemedia/ pdf/TA090guidance.pdf. Accessed January 21, 2008.
6. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee Lancet 348 1996 1329 1339
7. S. Yusuf, F. Zhao, S.R. Mehta, S. Chrolavics, G. Tognoni, and K.K. Fox Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation N Engl J Med 345 2001 494 502
8. M.S. Sabatine, C.P. Cannon, C.M. Gibson, J.L. López-Sendón, G. Montalescot, P. Theroux, M.J. Clayes, F. Cools, K.A. Hill, A.M. Skene, C.H. McCabe, and E. Braunwald CLARITY-TIMI 28 Investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation N Engl J Med 352 2005 1179 1189 (Pubitemid 40397259)
9. Z.M. Chen, L.X. Jiang, Y.P. Chen, J.X. Xie, H.C. Pan, R. Peto, R. Collins, and L.S. Liu 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 366 2005 1607 1621
10. D. Mukherjee, and E.J. Topol The role of low-molecular-weight heparin in cardiovascular diseases Prog Cardiovasc Dis 45 2002 139 156
11. C. Diehm, A. Schuster, J.R. Allenberg, H. Darius, R. Habrel, S. Lange, P. Pittrow, B. vn Strizkly, G. Tepohl, and H.J. Trampisch High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: cross-sectional study Atherosclerosis 172 2004 95 105 (Pubitemid 38058606)
12. S.T. Brookes, E. Whitely, M. Egger, G.D. Smith, P.A. Mulheran, and T.J. Peters Subgroup analyses in randomized trials: risks of subgroup-specific analyses; power and sample size for the interaction test J Clin Epidemiol 57 2004 229 236
13. J.M. Grouin, M. Coste, and J. Lewis Subgroup analyses in randomized clinical trials: statistical and regulatory issues J Biopharm Stat 15 2005 869 882
14. D. Jackson The power of the standard test for the presence of heterogeneity in meta-analysis Stat Med 25 2006 2688 2699
15. S.T. Brookes, E. Whitley, T.J. Peters, P.A. Mulheran, M. Egger, and Smith G. Davey Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives Health Technol Assess 5 2001 1 56
16. FDA Advisory Committee. 82nd Meeting of the Cardiovascular and Renal Drugs Committee; October 24, 1997. Available at: http://www.fda.gov/ohrms/ dockets/ac/97/transcpt/3338t2.pdf. Accessed January 21, 2008.
17. EMEA. Points to consider on multiplicity issues in clinical trials. 2002. Available at: http://www.emea.europa.eu/pdfs/human/ewp/090899en.pdf. Accessed September 28, 2009.
18. K.M. Einhäupl Stroke: a run down Dtsch Ärztebl 104 23 2007 A1648 1649