Skip to main content

Meta-Analyse randomisierter klinischer Studien, Publikationsbias und evidenzbasierte Medizin

  • Chapter
Methodik klinischer Studien

Part of the book series: Statistik und ihre Anwendungen ((STATIST))

Zusammenfassung

Randomisierte klinische Studien sind ein wichtiges Mittel der Erkenntnisgewinnung in der medizinischen Forschung; ihre Ergebnisse bilden eine wesentliche Grundlage für eine evidenzbasierte Medizin (Evidence-based Medicine; EbM). Dabei spielt die Zusammenfassung mehrerer Studien zur gleichen Fragestellung eine immer wichtigere Rolle. Werden die Daten bzw. Ergebnisse mehrerer unabhängig voneinander durchgeführter Studien in einer zusammenfassenden statistischen Analyse bewertet, spricht man von einer Meta-Analyse. Bezieht sich eine solche Meta-Analyse nur auf publizierte Studien, so kann ihr Ergebnis sehr stark davon abhängen, inwieweit alle zur Fragestellung durchgeführten Studien auch tatsächlich publiziert wurden. Dieses als Publikationsbias bezeichnete Phänomen muss bei der kritischen Bewertung der Ergebnisse von Meta-Analysen unbedingt beachtet werden. In diesem Kapitel wird diese Problematik in leicht verständlicher Form und am Beispiel von konkreten Studien diskutiert. Gleichzeitig wird auf das Prinzip der evidenzbasierten Medizin und die Rolle der Cochrane Collaboration hingewiesen.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 44.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 59.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Literatur

  • Agresti A. Categorical data analysis. New York: Wiley, 1990.

    Google Scholar 

  • AIMS Trial Study Group. Effect of intravenous APSAC on mortality after acute myocardial infarction: preliminary report of a placebo-controlled clinical trial. The Lancet 1988; 1: 545-549.

    Google Scholar 

  • AHCPR, 1992. Acute pain management: operative or medical procedures and trauma. Clinical practice guideline number 1. AHCPR Publication number 92-0032.

    Google Scholar 

  • Altman DG. Confidence intervals for the number needed to treat. British Medical Journal 1998; 317: 1309-1312.

    Google Scholar 

  • Altman DG, Deeks JJ, Sackett DL. Odds ratio should be avoided when events are common. British Medical Journal 1998; 317: 1318 (Letter).

    Google Scholar 

  • Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T for the CONSORT Group. The CONSORT statement for reporting randomized trials: explanation and elaboration. Annals of Internal Medicine 2001; 134: 663-694.

    Google Scholar 

  • Antes G, Bassler D, Galandi D. Systematische Übersichtsarbeiten. Ihre Rolle in einer evidenz-basierten Gesundheitsversorgung. Deutsches Ärzteblatt 1999; 96: A616-622.

    Google Scholar 

  • Antmann EM, Lau J, Kupelnick B, Mosteller F, Chalmers T. A comparison of results of meta-analyses of randomized controlled trials and recommendations of clinical experts. Journal of the American Medical Association 1992; 268: 240-248.

    Google Scholar 

  • Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, Guyatt GH, Harbour RT, Haugh MC, Henry D, Hill S, Jaeschke R, Leng G, Liberati A, Magrini N, Mason J, Middleton P, Mrukowicz J, O'Connell D, Oxman AD, Phillips B, Schunemann HJ, Edejer TT, Varonen H, Vist GE, Williams JW Jr, Zaza S; GRADE Working Group. Grading quality of evidence and strength of recommendations. British Medical Journal 2004;328:1490.

    Google Scholar 

  • Begg C, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994; 50: 1088-1101.

    Google Scholar 

  • Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials. The CONSORT Statement. Journal of the American Medical Association 1996; 276 637-649.

    Google Scholar 

  • Chalmers I, Enkin M, Keirse MJNC. Effective care in pregnancy and childbirth. Oxford: Oxford University Press, 1989.

    Google Scholar 

  • Cochran WG. Some methods for strengthening the common 2 Tests. Biometrics 1954; 10: 417-451.

    Google Scholar 

  • CLIP Group (Cancer of the Liver Italian Programme). Tamoxifen in treatment of hepatocellular carcinoma, randomised controlled trial. The Lancet 1998; 352: 17-20.

    Google Scholar 

  • Cochrane AL. Effectiveness and efficiency. Random reflections on health services. London: Nuffield Provincial Hospitals Trust, 1972.

    Google Scholar 

  • Crowley P, Chalmers I, Keirse MJNC. The effects of corticosteroid administration before preterm delivery. An overview of the evidence from controlled trials. British Journal of Obstetrics and Gynaecology 1990; 97: 11-25.

    Google Scholar 

  • Deeks JJ. Issues in the selection of a summary statistic for meta-analysis of clinical trials with binary outcomes. Statistics in Medicine 2002; 21: 1575-1600.

    Google Scholar 

  • Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Tamoxifen for early breast cancer, an overview of the randomised trials. The Lancet 1998; 351: 1451-1467.

    Google Scholar 

  • Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. The Lancet 2005; 365: 1687-1717.

    Google Scholar 

  • Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. British Medical Journal 1997; 315: 629-634.

    Google Scholar 

  • Egger M. Unter dem Metaskop, Möglichkeiten und Grenzen von Meta-Analysen. Schweizerische Medizinische Wochenschrift 1998; 128: 1893-1901.

    Google Scholar 

  • Fleiss JL. The statistical basis of meta-analysis. Statistical Methods in Medical Research 1993; 2: 121-145.

    Google Scholar 

  • Gail MH, Wieand S, Piantadosi S. Biased estimates of treatment effects in randomized experiments with nonlinear regressions and omitted covariates. Biometrika 1984; 71: 431-444.

    Google Scholar 

  • Greenland S, Robins JM. Estimation of a common effect parameter from sparse follow-up data. Biometrics 1985; 41: 55-68.

    Google Scholar 

  • Harbord RM, Egger M, Sterne JAC. A modified test for small-study effects in meta-analyses of controlled trials with binary endpoints. Statistics in Medicine, Published Online: 12 Dec 2005, DOI: 10.1002/sim.2380.

    Google Scholar 

  • Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in metaanalyses. British Medical Journal 2003; 327: 557-560.

    Google Scholar 

  • ISIS-2 (International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17187 cases of suspected myocardial infarction, ISIS - 2. The Lancet 1988; 2: 349-360.

    Google Scholar 

  • ISIS-4 (International Study of Infarct Survival) Collaborative Group. A randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58,050 patients with suspected acute myocardial infarction.) Collaborative Group. The Lancet 1995; 345:669-685.

    Google Scholar 

  • Khan K, Kunz R, Kleijnen J, Antes G. Systematische Übersichten und Meta-Analysen - Ein Handbuch für Ärzte in Klinik und Praxis sowie Experten im Gesundheitswesen. Springer, Berlin/Heidelberg; 2004.

    Google Scholar 

  • Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC. Cumulative meta-analysis of therapeutic trials for myocardial infarction. The New England Journal of Medicine 1992; 327: 248-254.

    Google Scholar 

  • Lewis S, Clarke M. Forest plots: trying to see the wood and the trees. British Medical Journal 2001; 322: 1479-1480.

    Google Scholar 

  • Light RJ, Pillemer DB. Summing up - the science of reviewing research. London: Havard University Press, 1984.

    Google Scholar 

  • Macaskill P, Walter SD, Irwig L. A comparison of methods to detect publication bias in meta-analysis. Statistics in Medicine 2001; 20: 641-654.

    Google Scholar 

  • Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. Journal of the National Cancer Institute 1959; 22: 719-748.

    Google Scholar 

  • Meinertz T, Kasper W, Schumacher M, Just H. The German multicentre trial of APSAC versus Heparin in patients with acute myocardial infarction. American Journal of Cardiology 1988; 62: 347-351.

    Google Scholar 

  • Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomized controlled trials, the QUOROM statement. The Lancet 1999; 354: 1896-1900.

    Google Scholar 

  • Moher D, Schulz KF, Altman DG for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Annals of Internal Medicine 2001; 134: 657-662.

    Google Scholar 

  • Olkin I. Statistical and theoretical considerations in meta-analysis. Journal of Clinical Epidemiology 1995; 48: 133-146.

    Google Scholar 

  • PORT Meta-analysis Trialists Group. Postoperative radiotherapy in non-small-cell lung cancer, systematic review and meta-analysis of individual patient data from nine randomised controlled trials. The Lancet 1998; 352: 257-263.

    Google Scholar 

  • R Development Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. ISBN 3-900051-07-0, 2006. (http://www.R-project.org).

    Google Scholar 

  • Ramsey PG, Carline JD, Inui TS, Larson EB, LoGerfo JP, Norcini JJ, Wenrich MD. Changes over time in the knowledge base of practicing internists. Journal of the American Medical Association 1991; 266: 1103-1107.

    Google Scholar 

  • Sackett DL, Richardson WS, Rosenberg WMC, Haynes RB. Evidenzbasierte Medizin [Deutsche Ausgabe von R. Kunz und L. Fritsche]. München: Zuckschwerdt Verlag, 1999.

    Google Scholar 

  • Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based medicine, what it is and what it isn‘t. British Medical Journal 1996; 312: 71-72.

    Google Scholar 

  • Schwarzer G. meta: Meta-Analysis. R package, 2006. (http://www.cran.r-project.org).

    Google Scholar 

  • Schwarzer G, Antes G, Schumacher M. Inflation of type I error rate in two statistical tests for the detection of publication bias in meta-analyses with binary outcomes. Statistics in Medicine 2002; 21: 2465-2477.

    Google Scholar 

  • Schwarzer G, Antes G, Schumacher M. A test for publication bias in meta-analysis with sparse binary data. Statistics in Medicine, Published Online: 5 Jun 2006, DOI:

    Google Scholar 

  • 10.1002/sim.2588.

    Google Scholar 

  • Simes RJ. Publication bias: The case for an international registry of clinical trials. Journal of Clinical Oncology 1986; 4:1529-1541.

    Google Scholar 

  • Simonetti RG, Liberati A, Angiolini C, Pagliaro L. Treatment of hepatocellular carcinoma. A systematic review of randomized controlled trials. Annals of Oncology 1997; 8: 117-136.

    Google Scholar 

  • Sindhu F. Are non-pharmacological nursing interventions for the management of pain effective? - A meta-analysis. Journal of Advanced Nursing 1996; 24: 1152-1159.

    Google Scholar 

  • Sterne JA, Egger M. Funnel plots for detecting bias in meta-analysis: guidelines on choice of axis. Journal of Clinical Epidemiology 2001; 54: 1046-1055.

    Google Scholar 

  • Stewart LA, Parmar MKB. Meta-analysis of the literature or of individual patient data, is there a difference? The Lancet 1993; 341: 418-422.

    Google Scholar 

  • Teo KK, Yusuf S, Collins R, Held PH, Peto R. Effects of intravenous magnesium in suspected acute myocardial infarction, overview of randomised trials. British Medical Journal 1991; 303: 1499-1503.

    Google Scholar 

  • Vickers A, Goyal N, Harland R, Rees R. Do certain countries produce only positive results? A systematic review of controlled trials. Controlled Clinical Trials 1998; 19: 159-166.

    Google Scholar 

  • Whitehead A. Meta-Analysis of controlled clinical trials. Chichester: Wiley, 2002.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

Copyright information

© 2008 Springer-Verlag Berlin Heidelberg

About this chapter

Cite this chapter

Schwarzer, G., Timmer, A., Galandi, D., Antes, G., Schumacher, M. (2008). Meta-Analyse randomisierter klinischer Studien, Publikationsbias und evidenzbasierte Medizin. In: Methodik klinischer Studien. Statistik und ihre Anwendungen. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-85136-3_8

Download citation

Publish with us

Policies and ethics