Abstract
This paper proposes several statistical approaches for analyzing spontaneous reports of adverse medical device events. The chi-square statistic is used to detect a sudden increase in reports from pairwise comparison of numbers of reports per month. The Cox-Stuart nonparametric trend test is used to detect a gradual, increasing trend in adverse events reports over time. The negative binomial probability model is also used to assess sudden increases by setting threshold values. In this paper, only numerator data (reports of adverse events), not denominator data (device use), are used. The Box-Jenkins ARIMA time series model failed to fit the observed data successfully due to the extremely irregular distributions, including many zeros, of the observed data.
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References
Conover, WJ. Practical Nonparametric Statistics. New York: John Wiley; 1980.
Fisz, M. Probability Theory and Mathematical Statistics. New York: John Wiley; 1963.
Feller, W. An Introduction to Probability Theory and its Applications. New York: John Wiley; 1968.
Bliss, CI, Fisher, RA. Fitting the negative binomial distribution to biological data. Biometrics. 1953;9: 176–200.
Anscombe, FJ. The statistical analysis of insect counts based on the negative binomial distribution. Biometrics. 1949;5:165–173.
Gallus, G, Radaelli, G, Marchi, M. Poisson approximation to a negative binomial process in the surveillance of rare health events. Methods Inf Med. 1991; 30:206–209.
Norwood, PK, Sampson, AR. A statistical methodology for postmarketing surveillance of adverse drug reaction. Stat Med. 1988;7:1023–1030.
Tsong Y. Comparing reporting rates of adverse events between drugs with adjustment for year of marketing and secular trends in total reporting. J Biopharma Stat. 1995;5:95–114.
Tsong Y. False Alarm rates of statistical methods used in determining increased frequency of reports on adverse drug reaction. J Biopharma Stat. 1992; 2:9–30.
Guideline For Postmarketing Reporting Of Adverse Drug Experiences. Rockville, MD: U. S. Food and Drug Administration; 1992.
Frisen, M. Evaluations of methods for statistical surveillance. Stat Med. 1992;11:1489–1502.
U.S. Centers for Disease Control. Symposium on statistics in surveillance. Stat Med. 1989;8:251–397.
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Lao, C.S., Kessler, L.G. & Gross, T.P. Proposed Statistical Methods for Signal Detection of Adverse Medical Device Events. Ther Innov Regul Sci 32, 183–191 (1998). https://doi.org/10.1177/009286159803200126
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DOI: https://doi.org/10.1177/009286159803200126