Abstract
This paper develops several statistical and economic models in order to analyze the accuracy and total cost of laboratory procedures commonly used in examining Pap smears for early indications of cervical cancer. In particular, the expected values, variances, and probability distributions are derived for the overall system sensitivity, overall system specificity, workload, and total system cost of several possible laboratory screening policies. These models are useful for analytically comparing possible alternative screening processes and for identifying the optimal minimum societal cost policy. Additionally, these models are used to show that the overall screening process never can have higher sensitivity nor lower specificity than the pathologist, that a rescreening rate of either 0% or 100% always will be economically optimal, and that total costs are highly variable period to period. While a primary objective of the present paper is to develop analytic and research tools, preliminary applied results suggest that significant improvements in sensitivity and reductions in total societal costs are possible by changing the policy currently required by the congressional Clinical Laboratory Improvement Amendments Act of 1988, typically with one to three repeated cytotechnologist screenings of presumed negative smears. Sensitivity analysis indicates these results are very dependent on cost and other inputs, and several directions for continued research therefore are described. Use of these models at the more micro laboratory and insurer levels, incorporation of automated rescreening devices, and extensions to mammography and other laboratory tests also are briefly discussed.
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K.A. Allen, S. Zaleski and M.B. Cohen, Review of negative Papanicolaou tests: Is the retrospective 5-year review necessary?, American Journal of Clinical Pathology 101, 1994, 19–21.
F.J. Anscombe, Rectifying inspection of lots, Journal of the American Statistical Association 56, 1961, 807–823.
P.R. Ashton, American Society of Cytotechnology quality assurance survey data: Summary Report, Acta Cytologica 33, 1989, 451–454.
J.C. Benneyan, Quality assurance and attribute inspection error: A review of behavioral and mathematical approaches for improving outgoing quality, Research Monograph, Industrial Engineering Department, University of Massachusetts, Amherst, 1991.
J.C. Benneyan, Optimal cancer screening policies at laboratory, insurer, versus societal levels: The global cost view in policy revision, Working Paper, 1995; available from author.
J.C. Benneyan, Mathematical and economic models of overall laboratory sensitivity, specificity, and cost using double or multiple reviews of positive determinations, Working Paper, 1995; available from author.
J.C. Benneyan, Some approaches to quality in the presence of inspection error, Doctoral Dissertation, University of Massachusetts, Amherst, MA, 1996.
J.C. Benneyan and F.C. Kaminsky, Sub-optimality of the CLIA 10% Pap smear and other clinical laboratory partial rescreening policies from a minimum cost viewpoint, Working Paper 1995; available from author.
J.C. Benneyan and F.C. Kaminsky, Statistical quality control in clinical laboratories, under review by Clinical Laboratory Management Review, 1996.
J.C. Benneyan, F.C. Kaminsky and D.I. Mullins, Mathematical models for evaluating the overall process sensitivity, specificity, and cost in the use of automated redirected screening in cytology, Acta Cytologica, in press, 1996.
Clinical Laboratory Improvement Amendments of 1988, P.L. 100–578, Congressional Record 134: 3828–63, 1988.
D.F. Cowan, Implementing a regulation-compliant quality improvement program on a commercial laboratory information system, Acta Cytologica 14, 1992, 407–414.
P. Curtis, J.J. Varenholt, B. Skinner, L. Addison, J. Resnick and M. Kebede, Development of a Pap smear quality-assurance system in family practice, Clinical Research and Methods 25, 1993, 135–139.
W.E. Deming,Quality, Productivity, and Competitive Position, MIT Center for Advanced Engineering Study, Cambridge, MA, 1982, pp. 267–311.
D.M. Eddy,Screening for Cancer: Theory, Analysis, and Design, Prentice-Hall, Englewood Cliffs, NJ, 1980.
J.D. Gay, L.D. Donaldson and J.R. Goellner, False-negative results in cervical cytologic studies, Acta Cytologica 29, 1985, 1043–1046.
W.M. Hindman, An approach to the problem of false negatives in gynecologic cytologic screening, Acta Cytologica 33, 1989, 814–818.
M.L. Hutchinson, S.L. Inhorn, J. Papillo and S.N. Lapidus, A perspective on modern quality control methods, to appear in Acta Cytologica, 1995.
M. Jaraiedi, D.S. Kochar and S,C. Jaisingh, Multiple inspections to meet desired outgoing quality, Journal of Quality Technology 19, 1987, 46–51.
F.C. Kaminsky and J.C. Benneyan, Alternative inspection policies in Pap smear testing for the detection of cervical cancer,International Applied Statistics in Medicine Conference, proceedings under publication, 1995.
F.C. Kaminsky, J.C. Benneyan and C. Andrzewski, The use of signal detection theory to determine the optimal cutoff point in enzyme immunosorbent assay testing for antibodies to HIV-1/2 and hepatitis, under review with the American Association of Blood Banks, 1995.
F.C. Kaminsky, J.C. Benneyan, R.J. Burke, D.L. Mullins and K.R. Haberle, A response to the letter “A perspective on modern quality control methods” by Hutchinson et al., to appear in Acta Cytologica, 1995.
F.C. Kaminsky, R.J. Burke, K.R. Haberle and D.L. Mullins, An economic model for comparing alternative policies for cervical cytologic smear screening, Acta Cytologica 39, 1995, 232–238.
D.L. Kent et al., Optimal scheduling of cystoscopies in monitoring for recurrent bladder cancer, Medical Decision Making 9, 1989, 26–27.
L.G. Koss, The Papanicolaou test for cervical cancer detection: A triumph and a tragedy, Journal of the American Medical Association 261, 1989, 737–743.
L.G. Koss, Cervical (Pap) smear: New directions, Cancer 71, 1993, 1406–1412.
S. Levey and E.R. Jennings, The use of control charts in clinical laboratories, American Journal of Clinical Pathology 20, 1950, 1056–1059, 1950.
G.D. Lundberg, Quality assurance in cervical cytology: The Papanicolaou smear, Journal of the American Medical Association 262, 1989, 1672–1679.
M.R. Melamed and B.J. Flehinger, Reevaluation of quality assurance in the cytology laboratory, Acta Cytologica 36, 1992, 61–65.
J.A. Pachciarz, M.I. Abbott, B. Gorman, C.E. Henneman and M. Kuhl, Continuous quality improvement of Pap smears in an ambulatory care facility, QRB: Quality Review Board 18, 1992, 229–235.
A.L. Paris, Conference on the state of the art in quality control measures for diagnostic cytology laboratories: Background and introduction, Acta Cytologica 33, 1989, 423–426.
J.D. Robb, The Pap smear is a cancer screening test: Why not put the screening error rate in the report?, Diagnostic Cytopathology 9, 1993, 485–486.
L.R. Rohr, Quality assurance in gynecologic cytology. What is practical?, American Journal of Clinical Pathology 94 1990, 754–758.
G. Wernimont, Use of control charts in the analytical laboratory, Ind. Eng. Chem. Anal. Ed. 18, 1946, 587–592.
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Benneyan, J.C., Kaminsky, F.C. Statistical and economic models for analysis and optimal design of laboratory screening policies for cervical cancer. Ann Oper Res 67, 235–285 (1996). https://doi.org/10.1007/BF02187031
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DOI: https://doi.org/10.1007/BF02187031