Abstract
The practice of medicine is becoming increasingly complex and, paradoxically, despite greater knowledge, even more uncertain1. Today, knowledge itself is defined on the basis of an arbitrary but accepted statistical test, performed in a randomised clinical trial2. What the physician thinks, suspects, believes, or has a hunch about, is assigned to the “not-knowing” category. Technical advances, expected to reduce clinical uncertainty, have not only contributed to its increase, but have even been used to obscure it1. Obscurity and uncertainty are also promoted by the lack of statistical expertise of the average clinician and by the sophisticated, sometimes overtly unclear, presentation of trial results.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Logan RL, Scott PJ. Uncertainty in clinical practice: implications for quality and costs of health care. Lancet 1996; 347: 595–8.
Hellman S, Hellman DS. Problems of the randomized clinical trial. N Engl J Med 1991; 324: 1585–9.
Ector H. Endpoints and trials: a matter of life and death. PACE 1994; 17: 1079–81.
Ector H, Rogers R, Rubens A, De Geest H. Classification of death in patients under antiarrhythmic treatment. PACE 1993; 16: 2250–4.
Epstein AE. AVID necessity. PACE 1993; 16: 1773–5.
Gottlieb SS. Dead is dead — artificial definitions are no substitute. Lancet 1997; 349: 662–3.
Lewis JA, Machin D. Intention to treat — who should use ITT? Br J Cancer 1993; 68: 647–50.
Sackett DL, Gent M. Controversy in counting and attributing events in clinical trials. N Engl J Med 1979; 301: 1410–12.
Epstein AE, Carlson MD, Fogoros RN, Higgins SL, Venditti FJ. Classification of death in antiarrhythmia trials. J Am Coll Cardiol 1996; 27: 433–42.
Kim SG, Fogoros RN, Furman S, Connolly SJ, Kuck KH, Moss AJ. Standardized reporting of ICD patient outcome: the report of a North American Society of Pacing and Electrophysiology Policy conference, 9–10 February 1993. PACE 1993; 16: 1358–62.
Echt DS, Liebson PR, Mitchell LB et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The cardiac arrhythmia suppression trial. N Engl J Med 1991; 324: 781–8.
Greene HL, Richardson DW, Barker AH et al. Classification of deaths after myocardial infarction as arrhythmic or nonarrhythmic (the cardiac arrhythmia pilot study). Am J Cardiol 1989; 63: 1–6.
Hinkle LE Jr, Thaler HT. Clinical classification of cardiac deaths. Circulation 1982; 65: 457–64.
Rogers R, Ector H, Rubens A, Timmermans C, Heidbüchel H, De Geest H. Classification of death in patients under antiarrhythmic treatment. In: Aubert AE, Ector H, Stroobandt R, editors. Cardiac Pacing and Electrophysiology. Dordrecht: Kluwer; 1994: 41–8.
Ector H. Endpoints and trials: a matter of life and death. Classification of death in patients under antiarrhythmic treatment. In: Oto AM, editor. Practice and Progress in Cardiac Pacing and Electrophysiology. Dordrecht: Kluwer; 1996: 1–5.
The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. Boston: Little, Brown; 1973: 286.
Lown B, Wolf M. Approaches to sudden death from coronary heart disease. Circulation 1971; 44: 130–42.
Lown B. Sudden cardiac death–1978. Circulation 1979; 60: 1593–9.
Passamani E. Clinical trials, are they ethical? N Engl J Med 1991; 324: 1589–92.
Feinstein AR. The limitations of randomized trials. Ann Intern Med 1983; 99: 544–50.
Moss AJ, Hall WJ, Cannom DS et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. N Engl J Med 1996; 335: 1933–40.
Cairns JA, Connolly SJ, Roberts R, Gent M. Randomised trial of outcome after myocardial infarction in patients with frequent or repetitive ventricular premature depolarizations: CAMIAT. Lancet 1997; 349: 675–82.
Julian DG, Camm AJ, Frangin G et al. Randomised trial of effect of amiodarone on mortality in patients with left-ventricular dysfunction after recent myocardial infarction: EMIAT. Lancet 1997; 349: 667–74.
Lee ET. Statistical Methods for Survival Analysis, 2nd edn. New York: John Wiley;1992.
Cox DR, Oakes D. Analysis of Survival Data. London: Chapman & Hall; 1992.
Whitehead J. The Design and Analysis of Sequential Clinical Trials, 2nd edn. Chicester; Ellis Horwood; 1992.
Gardner MJ, Altman DG. Statistics with Confidence. London: British Medical Journal, 1989.
Ector H, Jordaens L, Vanhaecke J. Survival analysis and clinical medicine. An observational comparison of the implantable cardioverter defibrillator, amiodarone treatment, and heart transplantation. Eur Heart J 1996; 17: 1444–7.
Yusuf S, Garg R, Zucker D. Analyses by the intention-totreat principle in randomized trials and databases. PACE 1991; 14: 2078–82.
Fischer LD, Dixon DO, Herson J, Frankowski RK, Hearson MS, Peace KE. Intention to treat in clinical trials. In: Peace KE, editor. Statistical Issues in Drug Research and Development. New York: Marcel Dekker; 1990: 331–50.
Robin ED, Lewiston NJ. Type 3 and type 4 errors in the statistical evaluation of clinical trials. Chest 1990; 98: 463–5.
Friedman PL, Stevenson WG. Unsustained ventricular tachycardia–to treat or not to treat,N Engl J Med 1996; 335: 1984–5.
Mason JW. A comparison of seven antiarrhythmic drugs in patients with ventricular tachyarrhythmias. N Engl J Med 1993; 329: 452–8.
McCarthy M. Implantable cardiac defibrillators cut deaths. Lancet 1997; 349: 1225.
Muschlin AI, Zipes DP. NASPE. 18th Annual Scientific Sessions, New Orleans, 7–10 May 1997.
Galbraith JK. Money. Whence it Came; Where it Went. New York: Bantam; 1975: 6.
Kassirer JP. Clinical trials and meta-analysis. What do they for us? N Engl J Med 1992; 327: 273–4.
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1998 Springer Science+Business Media Dordrecht
About this chapter
Cite this chapter
Ector, H., Heidbüchel, H., Van de Werf, F. (1998). Survival Analysis and Classification of Death in Patients under Antiarrhythmic Treatment. In: Vardas, P.E. (eds) Cardiac Arrhythmias, Pacing & Electrophysiology. Developments in Cardiovascular Medicine, vol 201. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-5254-9_18
Download citation
DOI: https://doi.org/10.1007/978-94-011-5254-9_18
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-010-6210-7
Online ISBN: 978-94-011-5254-9
eBook Packages: Springer Book Archive