Sage Journals: Discover world-class research

Abstract

Medical device companies report the performance of their products through actuarial survival curves. Analyses are based on “passive” databases. For pacemakers, a significant number of explanted devices may not be reported to manufacturers. Thus, expiant information is lost. High rates of underreporting of failures could result. Therefore, performance curves could indicate better survival rates than those that are actually occurring. Samples of closely-followed patients called active samples are used to adjust survival curves for underreported failures. Through simulations, this paper shows a need for a larger sample size for active components and what degree of underreporting failures would be necessary to assure better estimates using adjustments rather than estimates that ignore adjustments. The issues in this paper have a much broader context as pharmaceutical companies increasingly rely on medical devices to monitor patients ‘ health or deliver drugs. This can also apply to survival curves for adverse events in Phase 4 clinical trials.

Keywords

Capture-recapture methodology Cutler-Ederer method Postmarketing surveillance Product performance Survival analysis Warranty reports

Get full access to this article

View all access options for this article.

References

Mann

Schafer

Singpurwalla

. Methods for Statistical Analysis of Reliability and Life Data. New York, NY: John Wiley and Sons, Inc.; 1974.

Miller

. Survival Analysis. New York, NY: John Wiley and Sons, Inc.; 1981.

Kalbfleish

Prentice

. The Statistical Analysis of Failure Time Data. New York, NY: John Wiley and Sons, Inc.; 1980.

Cox

Oakes

. Analysis of Survival Data. London, UK: Chapman and Hall; 1984.

Gross

Clark

. Survival Distributions: Reliability Applications in the Biomedical Sciences. New York, NY: John Wiley and Sons Inc.; 1975.

Lawless

. Statistical Methods and Models for Lifetime Data. New York, NY: John Wiley and Sons, Inc.; 1982.

Nelson

. Applied Life Data Analysis. New York, NY: John Wiley and Sons, Inc.; 1982.

Meeker

Escobar

. Statistical Methods for Reliability Data. New York, NY: John Wiley and Sons, Inc.; 1998.

Lee

. Statistical Methods for Survival Data Analysis. Belmont, CA: Lifetime Learning Publications; 1980.

10.

Lee

. Statistical Methods for Survival Data Analysis. Second Edition. New York, NY: John Wiley and Sons, Inc.; 1992.

11.

Andersen

Keiding

. Survival Analysis, Overview. In: The Encyclopedia of Biostatistics, Volume 6. Armitage

Colton

, eds. Chichester, UK: John Wiley and Sons, Inc.; 1998.

12.

Berkson

Gage

. Calculation of survival rates for cancer. Proceedings of Staff Meetings, Mayo Clinic. 1950;25:250.

13.

Cutler

Ederer

. Maximum utilization of the life table method in analyzing survival. J Chronic Diseases. 1958;8:699–712.

14.

Kaplan

Meier

. Nonparametric estimation from incomplete observations J Am Stat Assoc. 1958;53:457–481.

15.

Buschke

Murthy

DNP

, eds. Product Warranty Handbook. New York, NY: Marcel Dekker, Inc.; 1996.

16.

Buschke

Murthy

DNP

. Warranty Cost Analysis. New York, NY: Marcel Dekker, Inc.; 1994.

17.

Leitch

Dear

Curteis

. Upward bias in estimates of pacemaker reliability: effect of unreported patient mortality. J Am Coll Cardiology. 1994;24:1078–1081.

18.

Brookmeyer

Yasui

. Statistical analysis of passive surveillance disease registry data. Biometrics. 1995;51:831–842.

19.

HIMA Pacemaker Task Force. Adjustment procedure for life table in presence of under-reported events. Washington, DC: Advanced Medical Technology Association; April 22, 1996.

20.

Center for Devices and Radiological Health, Food and Drug Administration. Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads). Rockville, MD: Center for Devices and Radiological Health, Food and Drug Administration; Revised June 9, 1993.

21.

Peto

Pike

Armitage

Breslow

Cox

Howard

Mantel

McPherson

Peto

Smith

. Design and analysis of randomized clinical trials requiring prolonged observation of each patient, Part II. Br J Cancer. 1977;35:1–39.

22.

Center for Devices and Radiological Health, Food and Drug Administration. Draft Guidance to Sponsors Regarding Required Postmarket Surveillance Studies of Pacemaker Pulse Generators. Rockville, MD: Center for Devices and Radiological Health, Food and Drug Administration; Revised September 15, 1995.

23.

Feinberg

. Bibliography on capture-recapture modeling with application to census undercount adjustment. Survey Methodology. 1992;18:143–154.

24.

Seber

GAF

. Capture-recapture methods. In: Encyclopedia of Statistical Sciences. Vol. 1. Kotz

Johnson

, eds. New York, NY: John Wiley and Sons, Inc.; 1982;367–374.

25.

Goldman

Hillman

. Exemplary data, sample size and power in the design of event-time clinical trials. Control Clin Trials. 1992;13:256–271.

Effects of Bias Adjustment on Actuarial Survival Curves

Abstract

Keywords

Get full access to this article

References