Liquid-based cervical cytologic smear study and conventional Papanicolaou smears: a metaanalysis of prospective studies comparing cytologic diagnosis and sample adequacy.

OBJECTIVE We sought to evaluate the cytologic diagnosis and sample adequacy of the liquid-based cervical cytologic smear (ThinPrep) compared with that of the conventional Papanicolaou smear. STUDY DESIGN Prospective studies of ThinPrep and conventional Papanicolaou smears were analyzed for cytologic diagnosis and sample adequacy. Computerized databases, references in published studies, and index reviews published in English were used to identify direct-to-vial and split-sample clinical trials of cervical smears performed by conventional and liquid-based techniques. Only published studies that used the Bethesda system nomenclature with clearly documented outcome data were included. Each trial was assessed for the quality of its method, inclusion and exclusion criteria, adequacy of randomization, sampling protocols, definition of outcome, and statistical analyses. RESULTS Twenty-five studies met inclusion criteria for this review. Odds ratios with 95% confidence intervals were calculated for each outcome. Estimates of odds ratios and risk differences for dichotomous outcomes were calculated by use of random and fixed-effects models. Homogeneity was tested across the studies. Results indicate that the ThinPrep test is as good as or superior to the conventional Papanicolaou smear in diagnosing uterine cervical premalignant abnormalities. Also the ThinPrep test provides improved sample adequacy when compared with the conventional Papanicolaou test. CONCLUSION The ThinPrep test improved sample adequacy and led to improved diagnosis of low-grade and high-grade squamous intraepithelial lesions. However, there is no difference in the rate of atypical cells of undetermined significance diagnosis between ThinPrep and conventional smear groups. The added cost of ThinPrep cytologic screening and, hence, its cost-effectiveness are not evaluated in this study.

[1]  D. Zahniser,et al.  ThinPrep Papanicolaou testing to reduce false-negative cervical cytology. , 1998, Archives of pathology & laboratory medicine.

[2]  F. Tezuka,et al.  Diagnostic efficacy and validity of the ThinPrep method in cervical cytology. , 1996, Acta cytologica.

[3]  N. Breslow,et al.  Statistical methods in cancer research: volume 1- The analysis of case-control studies , 1980 .

[4]  M. Hutchinson,et al.  Improved Accuracy for Cervical Cytology with the ThinPrep Method and the Endocervical Brush‐Spatula Collection Procedure , 1998, Journal of lower genital tract disease.

[5]  Jacalyn L. Papillo,et al.  Evaluation of the ThinPrep Pap Test in Clinical Practice , 1998, Acta Cytologica.

[6]  K. Hatch Multisite clinical outcome trial to evaluate performance of the thinprep pap test , 2000 .

[7]  T. Wright,et al.  Conventional cervical cytologic smears vs. ThinPrep smears. A paired comparison study on cervical cytology. , 1996, Acta cytologica.

[8]  N. M. Constantine,et al.  Colposcopically Directed Biopsies Provide a Basis for Comparing the Accuracy of ThinPrep and Papanicolaou Smears , 1995 .

[9]  M. Cummings,et al.  Improving cervical cytology screening in a remote, high risk population , 1999, The Medical journal of Australia.

[10]  M. Hutchinson,et al.  Efficacy of thinprep® preparation of cervical smears: A 1,000‐case, investigator‐sponsored study , 1994, Diagnostic cytopathology.

[11]  M. Sherman,et al.  Utility of liquid‐based cytology for cervical carcinoma screening , 1999, Cancer.

[12]  J. M. Roberts,et al.  Evaluation of the ThinPrep Pap test as an adjunct to the conventional Pap smear. , 1998, The Medical journal of Australia.

[13]  D. J. Hellman,et al.  Laboratory Implementation and Efficacy Assessment of the ThinPrep Cervical Cancer Screening System , 1998, Acta Cytologica.

[14]  E S Cibas,et al.  ThinPrep Processor. Clinical trials demonstrate an increased detection rate of abnormal cervical cytologic specimens. , 1994, American journal of clinical pathology.

[15]  H S Chen,et al.  Comparison of fluid-based, thin-layer processing and conventional Papanicolaou methods for uterine cervical cytology. , 1999, Journal of the Formosan Medical Association = Taiwan yi zhi.

[16]  A. Savino,et al.  Cervical smears prepared by an automated device versus the conventional method. A comparative analysis. , 1995, Acta cytologica.

[17]  N. Breslow,et al.  The analysis of case-control studies , 1980 .

[18]  S. Selvaggi,et al.  Use of the Thin Prep® Pap Test™ in clinical practice , 1999, Diagnostic cytopathology.

[19]  D. Davey,et al.  ThinPrep® Pap Test™ , 1999, Cancer.

[20]  M. Bur,et al.  Comparison of ThinPrep preparations with conventional cervicovaginal smears. Practical considerations. , 1995, Acta cytologica.

[21]  S. Kabawat,et al.  Performance of a fluid-based, thin-layer papanicolaou smear method in the clinical setting of an independent laboratory and an outpatient screening population in New England. , 2009, Archives of pathology & laboratory medicine.

[22]  D. Wilbur,et al.  Use of thin‐layer preparations for gynecologic smears with emphasis on the cytomorphology of high‐grade intraepithelial lesions and carcinomas , 1996, Diagnostic cytopathology.

[23]  K R Lee,et al.  Comparison of Conventional Papanicolaou Smears and a Fluid‐Based, Thin‐Layer System for Cervical Cancer Screening , 1997, Obstetrics and gynecology.

[24]  M. Hutchinson,et al.  The efficacy of an automated preparation device for cervical cytology. , 1991, American journal of clinical pathology.

[25]  A. Cooper,et al.  Cervical cancer screening: what is cost-effectiveness? , 1999, Journal of lower genital tract disease.

[26]  V. Lucente,et al.  The promise and risk of a new technology , 1998, Cancer.

[27]  E S Cibas,et al.  A new look at cervical cytology. ThinPrep multicenter trial results. , 1992, Acta cytologica.