Trends in the use of cervical cancer screening tests in a large medical claims database, United States, 2013-2019.

OBJECTIVE: To examine trends in the use of cervical cancer screening tests during 2013-2019 among commercially insured women. METHODS: The study population included women of all ages with continuous enrollment each year in the IBM MarketScan commercial or Medicare supplemental databases and without known history of cervical cancer or precancer (range = 6.9-9.8 million women per year). Annual cervical cancer screening test use was examined by three modalities: cytology alone, cytology plus HPV testing (cotesting), and HPV testing alone. Trends were assessed using 2-sided Poisson regression. RESULTS: Use of cytology alone decreased from 34.2% in 2013 to 26.4% in 2019 among women aged 21-29 years (P < .0001). Among women aged 30-64 years, use of cytology alone decreased from 18.9% in 2013 to 8.6% in 2019 (P < .0001), whereas cotesting use increased from 14.9% in 2013 to 19.3% in 2019 (P < .0001). Annual test use for HPV testing alone was below 0.5% in all age groups throughout the study period. Annually, 8.7%-13.6% of women aged 18-20 years received cervical cancer screening. There were persistent differences in screening test use by metropolitan residence and census regions despite similar temporal trends. CONCLUSIONS: Temporal changes in the use of cervical cancer screening tests among commercially insured women track changes in clinical guidelines. Screening test use among individuals younger than 21 years shows that many young women are inappropriately screened for cervical cancer.

Cervical testing beyond the screening target age - A register-based cohort study from Finland.

OBJECTIVE: It has been proposed that cervical cancer screening should be continued in women with previous abnormal results or irregular attendance. We examined the coverage and factors that might influence cervical testing beyond the age range of the organized cervical screening programme in Finland. The national programme invites women in every five years least until the age of 60. After the stopping age, only opportunistic service is available. METHODS: Data on cervical testing were collected from the Mass Screening Registry and providers of opportunistic Pap/HPV-testing and were linked with information on socio-economic variables. The study included 373,353 women who had at least one invitation to the national screening programme between ages 50-60 years, and who were aged 65-74 years in the follow-up period 2006-2016. Multivariable binomial regression models were conducted to determine associations. RESULTS: Altogether 33% of the study population had been tested at least once at ages 65-74 years. Previous regular screening attendance (adjRR 1.70; 95% CI 1.67-1.73) and earlier abnormal results (adjRR 2.08; 95% CI 2.04-2.12) were most clearly related to higher testing adherence at older age. Other factors related to higher testing adherence were urban area of residence, domestic mother tongue, high education level, and high socio-economic status. CONCLUSION: Testing at older age was frequent with normal results, whereas only a small proportion of women with earlier abnormal results or irregular attendance were tested. The upper age limit of the national programme should be raised to 65 years, and the invitations thereafter should be targeted to selected high-risk groups.

Cervical Stenosis: Previously Unrecognized Cause of False-Negative Human Papillomavirus Tests in Women Developing Cervical Cancer.

OBJECTIVES: Cervical stenosis can jeopardize adequate posttreatment cytologic follow-up of patients treated for high-grade cervical intraepithelial lesions. An impact on human papillomavirus (HPV) testing has not been described. MATERIALS AND METHODS: We describe 2 patients with cervical stenosis, followed by cytology and HPV co-testing after excisions of high-grade cervical intraepithelial lesions. Each had 1 or more co-test "double-negative" results. Hysterectomies revealed unexpected cervical carcinomas. RESULTS: In case 1, an 80-year-old woman with complete cervical stenosis and earlier high-grade squamous dysplasia presented with abdominal pain, nausea, and an enlarged uterus. Attempted endometrial biopsy was unsuccessful. Cytology and HPV tests 9 months earlier were negative. Hysterectomy revealed a cervical squamous carcinoma. In case 2, a 40-year-old woman followed conservatively after excision of endocervical adenocarcinoma in situ had 5 follow-up cytology and HPV co-tests. All were HPV negative. Elective hysterectomy revealed cervical adenocarcinoma. Both carcinomas tested HPV positive. CONCLUSIONS: Cervical stenosis in women developing cervical cancer can cause misleading sampling and false-negative HPV test results.

Intraoperative Human Papillomavirus Test Predicts 24-Month High-Grade Squamous Intraepithelial Lesion Recurrence Saving Costs: A Prospective Cohort Study.

OBJECTIVES: The human papilloma virus (HPV) test is recommended in the posttreatment follow-up of cervical intraepithelial neoplasia. The aim of the study was to assess whether the intraoperative HPV (IOP-HPV) test had a similar diagnostic accuracy that HPV test performed at 6 months to predict high-grade squamous intraepithelial lesion (HSIL) recurrence. MATERIALS AND METHODS: In a prospective cohort study, 304 women diagnosed with HSIL by biopsy and/or endocervical curettage before treatment and/or confirmation in the histological specimen were included. Immediately after surgery, HPV testing was performed. This test was compared with the test at 6 months and other predictors of recurrence. Patients were followed for 24 months. An economic analysis was performed to compare the costs of IOP-HPV and HPV test at 6 months. RESULTS: Recurrence rate of HSIL was 6.2% (19 patients). The diagnostic accuracy of the IOP-HPV test to predict HSIL recurrence at 24 months was similar to the HPV test at 6 months, with comparative sensitivities of 100% versus 86.7%, specificities of 82.0% versus 77.9%, positive predictive values of 27.1% versus 18.1%, and negative predictive values of 100% versus 99.0%. Direct economic saving per high-grade intraepithelial lesion patient was 172.8 &OV0556;. CONCLUSIONS: The HPV test performed after loop electrosurgical resection procedure predicted recurrence of HSIL at 24 months with a similar diagnostic accuracy than the HPV test at 6 months. The use of the IOP-HPV test in the management of HSIL will allow early detection of the risk of recurrent disease and to save costs because of potential suppression of the need of HPV and follow-up controls at 6 months.

Cervical Cancer, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology.

Cervical cancer is a malignant epithelial tumor that forms in the uterine cervix. Most cases of cervical cancer are preventable through human papilloma virus (HPV) vaccination, routine screening, and treatment of precancerous lesions. However, due to inadequate screening protocols in many regions of the world, cervical cancer remains the fourth-most common cancer in women globally. The complete NCCN Guidelines for Cervical Cancer provide recommendations for the diagnosis, evaluation, and treatment of cervical cancer. This manuscript discusses guiding principles for the workup, staging, and treatment of early stage and locally advanced cervical cancer, as well as evidence for these recommendations. For recommendations regarding treatment of recurrent or metastatic disease, please see the full guidelines on NCCN.org.

The impact of blind peer review (team reading) of equivocal/abnormal Papanicolaou smears on inter-reader agreement.

OBJECTIVE: Peer review of equivocal/abnormal Papanicolaou smears is a standard internal quality assurance measure in cervical cancer screening laboratories. In 2014, we introduced a new method for peer review involving blinding the identity of the first reader. We present the comparison of different measures of inter-reader agreement in 2013 and 2014 in order to measure the impact of blind peer review on possible cognitive biases in reading. METHODS: All suspect slides are proposed for peer review; a single reader's peer reviews are registered independently, with discordant cases discussed for consensus diagnosis. Since 2014, the first reader's name has been blinded to peers. We computed how frequently the initial diagnosis was changed, and how frequently a single reader influenced the final diagnosis when the initial one was changed. We compared κ of the first reader and that of other readers with final diagnosis. Data from 2013 were compared to those of 2014. RESULTS: The final diagnosis changed in 22.9% of cases (range 16.8%-34.4%) in 2013 and in 26.8% (range 13.9%-35.6%) in 2014 (P = .2). Individual peer diagnoses agreed with final diagnosis in 52.3% (range 41.9%-66.3%) in 2013 and in 50.2% (range 36.0%-65.8%) in 2014 (P = .55). The cytologist having the highest proportion of confirmed diagnoses was also the most influential on final diagnosis, both in 2013 and in 2014. Agreement between first reader and final diagnosis was higher than that of each reader in 2013 and in 2014. CONCLUSIONS: Blinding the identity of the first reader had little or no impact on inter-reader agreement measures in our laboratory.

Internal quality control indicators in cervical cytopathology of a university laboratory.

INTRODUCTION: To evaluate the internal quality control indicators and quality management programme in a university cytopathology laboratory. METHODS: All results of conventional cervical smears tests (taken from the SISCAN, the Brazilian cervical cancer screening system) of women aged ≥15 years at the time of Papanicolaou smear specimen collection during January 2007-December 2014 were included. The final results of the cytopathology were classified in accordance with the Bethesda System. The variables included in the database were the woman's name, date of birth, and age at the time of sampling (15-30, 31-40 and older than 40 years). RESULTS: In this period, 50 286 cytopathology examinations were carried out. Of these, 44 386 (91.34%) were negative for malignancy or unsatisfactory and 4209 (8.66%) presented epithelial abnormalities. The percentage of the tests consistent with atypical squamous cells (ASC) between satisfactory examinations was 4.12%; the percentage of tests compatible with ASC among abnormal examinations was 47.87%; the ASC/squamous intraepithelial lesion) ratio was 0.97 and the percentage of high-grade squamous intraepithelial lesion among satisfactory tests was 2.21%, and the 5-year retrospective review identified 4.97% of false-negative results. CONCLUSION: All rates obtained were consistent over the years and within the recommended values by Federal Regulation of Brazil. This demonstrates the efficacy of our established internal quality monitoring and continuing education, reflecting the commitment of the team involved in the release of smear reports.

Outcomes of endoscopic ultrasound-guided pancreatic FNAC diagnosis for solid and cystic lesions at Manchester Royal Infirmary based upon the Papanicolaou Society of Cytopathology pancreaticobiliary terminology classification scheme.

OBJECTIVE: To compare endoscopic ultrasound (EUS)-FNAC diagnosis of pancreatic lesions with patient outcome based upon the Papanicolaou Society of Cytopathology pancreaticobiliary terminology classification scheme diagnostic categories: Panc 1 (non-diagnostic); Panc 2 (negative for malignancy/neoplasia); Panc 3 (atypical); Panc 4B (neoplastic, benign); Panc 4O (neoplastic, other); Panc 5 (suspicious of malignancy); and Panc 6 (positive/malignant). METHODS: All EUS-FNA pancreas specimens taken at Manchester Royal Infirmary in 2015 were prospectively classified according to the above scheme at the time of cytology reporting and data recorded prospectively. Subsequently, outcomes based on clinical follow-up or histopathology diagnosis were compared with the cytology diagnosis. RESULTS: 120 EUS-FNA pancreas specimens from 111 patients were received, of which 112 (93.3%) specimens had follow-up data. There were 79 and 41 EUS-FNA pancreas specimens from solid and cystic lesions, respectively. Based on the cytology diagnosis the specimens were classified as Panc 1 (7.5%), Panc 2 (33.3%), Panc 3 (2.5%), Panc 4B (2.5%), Panc 4O (15.0%), Panc 5 (3.3%) and Panc 6 (35.9%). The performance indicators for diagnosis of malignancy or neoplasia with malignant potential, included sensitivity (95.4%), specificity (100%), positive predictive value (100%), negative predictive value (92.3%), false positive rate (0%) and false negative rate (4.6%). CONCLUSIONS: The Papanicolaou Society of Cytopathology pancreaticobiliary terminology classification scheme is a logical system that can easily be introduced in a diagnostic cytopathology service. This classification scheme acts as an aid to diagnostic reporting, clear communication of significant results including risk of neoplasia/malignancy to clinicians, clinical audit and comparison of results with other centres.

Screening with Papanicolaou tests in Alberta: Are we Choosing Wisely?

OBJECTIVE: To describe the prevalence and geographic distribution of cervical cancer screening, as well as the age groups of those undergoing screening, in Alberta, and to determine if screening practices conform to current guidelines and follow Choosing Wisely Canada recommendations. DESIGN: Descriptive study using data from the Alberta Ministry of Health Analytics and Performance Reporting Branch. SETTING: Alberta. PARTICIPANTS: Women who had 1 or more Papanicolaou tests between 2011 and 2013. MAIN OUTCOME MEASURES: Number of women aged 15 to 20 and those aged 70 and older who had 1 or more Pap tests in a 3-year period; year-to-year trends in screening rates for women in these 2 age groups; trends in screening rates in various geographic regions (ie, cities and zones) in Alberta; and the discipline of clinicians who ordered the Pap tests. RESULTS: Between 2011 and 2013, 805 632 women in the province of Alberta had 1 or more Pap tests for cervical cancer screening. Overall, 25 511 (17.5%) women aged 15 to 20 and 16 818 (10.3%) aged 70 and older were screened contrary to most existing guidelines. Screening rates varied markedly in different geographic regions of the province. Most Pap tests were ordered by family physicians or general practitioners. CONCLUSION: Within the geographic regions of Alberta, provincial, national, and international guidelines for screening with Pap tests are inconsistently followed. This strongly echoes the need for clinicians and patients to consider the Choosing Wisely Canada recommendations and current guidelines for cervical cancer screening.

Technical proficiency in cytopathology: assessment through external quality assurance.

OBJECTIVE: To assess both the feasibility and value of conducting an external quality assurance programme concerning technical aspects of cytopathology laboratory practice, and the interest by laboratories in enrolling in such a programme. METHODS: Six technical surveys, comprising staining exercises and questionnaires relating to laboratory practice, were distributed over a 4-year period to the approximately 220 laboratories enrolled in the RCPAQAP Cytopathology slide survey modules. Staining exercises using the Papanicolaou and Romanowsky techniques, the preparation of urine and body fluid specimens and immunocytochemistry on the cell block material were assessed. Accompanying relevant questionnaires were included, and one survey comprised a questionnaire alone concerning the collection of urinary tract and body fluid samples. RESULTS: Provision of an external cytopathology technical module was feasible for the RCPAQAP and participation rates (maximum of 87% per survey; average 68% for stained slides and 66% for questionnaires) were commendable, particularly considering these were optional undertakings with some exercises not applicable to all laboratories. The great majority of submitted slides were scored as satisfactory, and there was an especially high standard for the immunocytochemical staining exercise with 95% considered satisfactory, including 50.6% with a perfect score. Reasons for suboptimal scores were provided for potential quality improvement for interested laboratories. A wealth of information relating to laboratory practice was provided to the RCPAQAP which was collated and summarised for laboratory use. CONCLUSIONS: The provision of a technical module in cytopathology is both a feasible and valuable undertaking of interest to laboratories which should become standard practice for cytopathology external quality assurance providers.

Comparing Papanicolaou test results obtained during pregnancy and post-partum.

AIM: Cervical cancer onset initially occurs during youth. Papanicolaou tests performed in early pregnancy can detect cervical cancer; however, Papanicolaou tests during pregnancy have been noted to be inaccurate, reflecting changes associated with pregnancy. Therefore, we assessed the effect of pregnancy on Papanicolaou test results. METHODS: Of 1351 pregnant women who delivered at Ise Red Cross Hospital between January 2010 and December 2014, 1213 underwent Papanicolaou tests at early pregnancy and post-partum. We compared the Papanicolaou test results. RESULTS: The results of the Papanicolaou test were different in 32 patients. Of the 1191 patients negative for intraepithelial lesions or malignancy in early pregnancy, 16 had other cytological abnormalities post-partum. We performed therapeutic conization post-partum in four patients. The Papanicolaou test results in early pregnancy of the four patients were negative for intraepithelial lesions or malignancy in one patient, atypical squamous cells of undetermined significance in one and high-grade squamous intraepithelial lesion in two. CONCLUSION: The results of the Papanicolaou test during pregnancy may not be accurate because of the influence of hormones associated with pregnancy. Taking advantage of the one-month post-partum screening visit can lead to early detection and treatment of cervical cancer in young people.

[Quality of the exo-endocervical sampling in the prevention of uterine cervix cancer]. / Calidad de la toma exo-endocervical en la prevención del cáncer de cuello uterino.

Cervical and vaginal cytology, Papanicolaou test (PAP), is the most effective test for screening of preneoplastic lesions, and cervical cancer prevention. Its sensitivity goes from 50 to 98%, according to different statistics, and this variation is related to the sampling procedure. A satisfactory smear should be taken from the transformation zone, the junction between endocervix and exocervix. According to Bethesda, metaplastic and/or endocervical cells should be observed under the microscope. The traditional PAP smear includes an exo-endocervical sampling using the Ayre spatula; however, only near 50% of the smears are representative of the transformation zone. In this case report, we present the case of a 40-year-old woman who had negative cytology in five consecutive annual PAP smears, none of which showed metaplastic or endocervical cells. A new sample evidenced a carcinoma in situ (HSIL: high-grade squamous intraepithelial lesion). We emphasize the importance of performing a correct exo-endocervical sampling to allow prompt detection of all premalignant lesions and to prevent cervical cancer, which still persists with high mortality worldwide.

Daily peer review of abnormal cervical smears in the assessment of individual practice as an additional method of internal quality control.

OBJECTIVE: An important internal quality control system used in the Cancer Prevention and Research Institute cytopathology laboratory in Florence is the peer review procedure, based on the review of all abnormal cytological smears which routinely emerge. Peer review is an important training opportunity for all cytologists, especially for those with less experience. This article shows the results of the peer review procedure. METHODS: Of the 63 754 Papanicolaou (Pap) smears screened in 2011, 1086 were considered to be abnormal [at least atypical squamous cells of undetermined significance (ASC-US+)] on primary screening (selected by a single cytologist) and were subjected to the peer review procedure. The overall performance of the laboratory's cytologists was evaluated using a multiple rater analysis and the comparison of each cytologist with the final diagnosis. Further, the agreement was assessed by means of Cohen's kappa and weighted kappa statistics. RESULTS: In general, a moderate/substantial level of agreement between the ten cytologists and the final diagnoses was evident. Kappa values for each reader compared with the final diagnosis ranged from 0.54 to 0.69. The overall kappa value was 0.62 [95% confidence interval (CI), 0.58-0.66] and overall weighted kappa value was 0.76 (95% CI, 0.74-0.79). The category-specific agreement showed the lowest values for atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion (ASC-H). CONCLUSION: In summary, peer review represents an important internal quality control in the evaluation and improvement of inter-observer agreement and of the functioning of the laboratory as a whole. Multi-head microscope sessions may improve particularly the reproducibility of borderline diagnoses and, above all, can be an important training contribution for cytologists.

Evaluation of Direct Visual Inspection of the Cervix in Detecting Cytology Diagnosed Squamous Intraepithelial Lesion in Women of known HIV Status. A Randomized Trial (CANHIV Study).

A two-arm, open label, randomized study, evaluated the test characteristics of visual inspection of cervix with Acetic acid(VIA) and Lugol?s Iodine(VILI) in detecting cytology diagnosed squamous intraepithelial lesion(SIL) in 1160 women of known HIV status in southwestern Nigerian. Using SIL as reference standard and the HIV status masked, VIA and VILI had similar test characteristics except for the positive predictive value in which VIA value of 91.5% was significantly higher than 77.7% for VILI ( p=0.01). Among HIV positive women, VILI performed poorly across all the 4 test characteristics compared to VIA. Among severely immuno-compromised HIV positive participants VILI performance was consistently below 80% across all test characteristics (sensitivity-70.0%; specificity-66.9%; positive predictive value-46.7%; negative predictive value(NPV)-50.0%) compared to VIA (Senstivity-71.3%; specificity-88.2%; positive predictive value-83.3%; negative predictive value -88.2). Our study shows that VILI is insufficiently sensitive and specific in the presence of HIV infection especially in those with severe immunosuppression. Based on VIA?s acceptable sensitivity and NPV in all situations, it is recommended for cervical cancer screening in HIV positive women and in settings of high HIV burden.

Cervical Cancer Screening for Patients on the Female-to-Male Spectrum: a Narrative Review and Guide for Clinicians.

Guidelines for cervical cancer screening have evolved rapidly over the last several years, with a trend toward longer intervals between screenings and an increasing number of screening options, such as Pap/HPV co-testing and HPV testing as a primary screening. However, gynecological recommendations often do not include clinical considerations specific to patients on the female-to-male (FTM) spectrum. Both patients and providers may not accurately assess risk for HPV and other sexually transmitted infections, understand barriers to care, or be aware of recommendations for cervical cancer screening and other appropriate sexual and reproductive health services for this patient population. We review the evidence and provide guidance on minimizing emotional discomfort before, during, and after a pelvic exam, minimizing physical discomfort during the exam, and making adaptations to account for testosterone-induced anatomical changes common among FTM patients.

A unification of models for meta-analysis of diagnostic accuracy studies without a gold standard.

Several statistical methods for meta-analysis of diagnostic accuracy studies have been discussed in the presence of a gold standard. However, in practice, the selected reference test may be imperfect due to measurement error, non-existence, invasive nature, or expensive cost of a gold standard. It has been suggested that treating an imperfect reference test as a gold standard can lead to substantial bias in the estimation of diagnostic test accuracy. Recently, two models have been proposed to account for imperfect reference test, namely, a multivariate generalized linear mixed model (MGLMM) and a hierarchical summary receiver operating characteristic (HSROC) model. Both models are very flexible in accounting for heterogeneity in accuracies of tests across studies as well as the dependence between tests. In this article, we show that these two models, although with different formulations, are closely related and are equivalent in the absence of study-level covariates. Furthermore, we provide the exact relations between the parameters of these two models and assumptions under which two models can be reduced to equivalent submodels. On the other hand, we show that some submodels of the MGLMM do not have corresponding equivalent submodels of the HSROC model, and vice versa. With three real examples, we illustrate the cases when fitting the MGLMM and HSROC models leads to equivalent submodels and hence identical inference, and the cases when the inferences from two models are slightly different. Our results generalize the important relations between the bivariate generalized linear mixed model and HSROC model when the reference test is a gold standard.

The Pap Test and Bethesda 2014. "The reports of my demise have been greatly exaggerated." (after a quotation from Mark Twain).

The history of 'The Bethesda System' for reporting cervical cytology goes back almost 3 decades. This terminology and the process that created it have had a profound impact on the practice of cervical cytology for laboratorians and clinicians alike. The Bethesda conferences and their ensuing output have also set the stage for standardization of terminology across multiple organ systems, including both cytology and histology, have initiated significant research in the biology and cost-effective management for human papillomavirus-associated anogenital lesions, and, finally, have fostered worldwide unification of clinical management for these lesions. Herein, we summarize the process and rationale by which updates were made to the terminology in 2014 and outline the contents of the new, third edition of the Bethesda atlas and corresponding website.

Does Cytological Laboratory Holds the Responsibility for the Low Sensitivity of the PAP Test in Detecting Endometrial Cancer?

Endometrial cancer is the most common gynecological cancer but there is no economically justified screening method. Although we can detect endometrial cells in the sample using PAP test, many studies show low sensitivity and positive predictive value of PAP test for the diagnosis of endometrial cancer. The goal of this research was to determine significance of PAP test for the diagnostics of endometrial carcinoma. Sensitivity and specificity were analyzed with statistical parameters. VCE (vaginal, cervical, endocervical) smears of patients with histologically proven endometrial carcinoma were re-examined in order to determine the proportion of false negative results for endometrial cancer cells in the VCE samples. Study group consisted of all consecutive patients with PAP test performed at the Department of Clinical Cytology of the University Hospital Center Osijek from 2002 until the end of 2014. There was one inclusion criteria: subsequent hysterectomy or curettage within the six month after the PAP test, regardless of histological finding. From a total of 263 patients with previous PAP test and histologically proven endometrial cancer, endometrial cancer was cytologicaly diagnosed in 24.7% (including suspicious and positive findings), while 66.2% patients had normal cytological findings. The diagnostic value of PAP test in detection of endometrial cancer was statistically revealed with 25% sensitivity and 99% specificity. To determine false negative rate VCE samples were reviewed for patients with histologically proven endometrial cancer and negative VCE findings. There were a total of five negative results. In one case revision did not changed the original negative diagnosis, but benign endometrial cells, a lot of blood and inadequate cytohormonal status were found. In three out of four reviewed samples there were missed cells of endometrial adenocarcinoma. Review of remaining VCE sample upgraded the diagnosis from negative to suspicious for endometrial cancer. Proportion of error in the detection of endometrial cancer using cytological findings was 3.4% (true false negatives). Negative rate of the cytological findings in the detection of endometrial cancer was 66.2%. PAP test is not a suitable method for detection of endometrial carcinoma due to low sensitivity (25%). The main cause of negative findings in PAP test was lack of diagnostic cells in the sample.

Female-to-male patients have high prevalence of unsatisfactory Paps compared to non-transgender females: implications for cervical cancer screening.

BACKGROUND: Little is known about whether and how screening for cancers of natal reproductive structures, including cervical cancer, in female-to-male (FTM) transgender individuals differs from cancer screening among non-transgender females. OBJECTIVE: To investigate anecdotal reports from clinicians of high rates of inadequate Papanicolaou (Pap) tests among transgender men. DESIGN: Results of Pap tests performed on 233 FTM and 3,625 female patients at an urban community health center between 2006 and 2012 were extracted from an electronic medical record. KEY RESULTS: Compared to female patients, FTM patients were more likely to have an inadequate Pap, with prevalence of inadequate samples 8.3 times higher among tests of FTM patients (10.8% vs. 1.3% of tests). FTM patients had over ten times higher odds of having an inadequate Pap after adjusting for age, race, and body mass index (AOR = 10.77, 95% CI = 6.83, 16.83). When years on testosterone therapy was added to the model, the relationship between transgender identity and Pap inadequacy was attenuated, but remained strongly associated (AOR = 6.01, 95% CI = 3.00, 11.50), and time on testosterone was also associated (AOR = 1.19, 95% CI 1.04, 1.36). FTM patients were more likely than females to have had multiple inadequate tests, and had longer latency to follow-up testing. CONCLUSIONS: The high unsatisfactory sample prevalence among FTM patients is likely due to a combination of physical changes induced by testosterone therapy and provider/patient discomfort with the exam. Clinicians should receive training in increasing comfort for FTM patients during the exam. FTM patients should be alerted that high rates of inadequate screening may require follow-up testing. Alternatives to repeated Pap testing, such as cytologic reprocessing of inadequate samples or primary human papillomavirus (HPV) DNA screening, should be studied for efficacy and acceptability among FTM patients.