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Contemporary National Trends of Prostate Cancer Screening Among Privately Insured Men in the United States
Accepted Manuscript Title: Contemporary National Trends of Prostate Cancer Screening among Privately Insured Men in the United States Author: Simon P. Kim, R. Jeffrey Karnes, Cary P. Gross, Neal J. Meropol, Holly Van Houten, Robert Abouassaly, Nilay D. Shah PII: DOI: Reference:
S0090-4295(16)30512-X http://dx.doi.org/doi: 10.1016/j.urology.2016.06.067 URL 19965
To appear in:
Urology
Received date: Accepted date:
10-4-2016 14-6-2016
Please cite this article as: Simon P. Kim, R. Jeffrey Karnes, Cary P. Gross, Neal J. Meropol, Holly Van Houten, Robert Abouassaly, Nilay D. Shah, Contemporary National Trends of Prostate Cancer Screening among Privately Insured Men in the United States, Urology (2016), http://dx.doi.org/doi: 10.1016/j.urology.2016.06.067. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
CONTEMPORARY NATIONAL TRENDS OF PROSTATE CANCER SCREENING AMONG PRIVATELY INSURED MEN IN THE UNITED STATES
Simon P. Kim, MD, MPH1-3; R. Jeffrey Karnes, MD4; Cary P. Gross, MD3,5; Neal J. Meropol, MD2; Holly Van Houten, BA6; Robert Abouassaly, MD, MS1,2; Nilay D. Shah, PhD6,7 1
University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Urology Institute, Center for Quality and Outcomes, Cleveland, Ohio 2 University Hospitals Case Medical Center, Seidman Cancer Center, Case Western Comprehensive Cancer Center, Cleveland, Ohio 3 Yale University, Cancer Outcomes, Public Policy and Effectiveness Research (COPPER) Center, New Haven, Connecticut 4 Mayo Clinic, Department of Urology, Rochester, Minnesota 5 Yale University, Department of Internal Medicine, New Haven, Connecticut 6 Mayo Clinic, Division of Health Care Policy and Research, Rochester, Minnesota 7 Mayo Clinic, Knowledge and Evaluation Research (KER) Unit, Rochester, Minnesota Correspondence:
Simon P. Kim, MD, MPH University Hospitals Case Medical Center Case Western Reserve University Medical School Urology Institute Center for Quality and Outcomes 11000 Euclid Avenue Lakeside Building Suite 4954 Mailstop LKS 5046 Cleveland, Ohio 44106 E-mail: [email protected] Fax: 216-844-1900
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Conflict of Interest: None Support/Financial Disclosure: Dr. Simon P. Kim is supported through a career development award from the Conquer Cancer Foundation of the American Cancer Society Career Development Award. Manuscript Word Count: 2,413 Abstract Word Count: 246 Tables: 3 Figures: 0 Appendices: 0 References: 30 Key Words: Prostate Cancer, PSA, Clinical Practice Guidelines ABSTRACT OBJECTIVES: To assess the possible impact of changes to the clinical guidelines from U.S. Preventive Service Task Force (USPSTF) recommendations in 2012 on the national trends of PSA screening and identify patient characteristics associated with PSA screening from a large private insurance database. METHODS: We conducted a retrospective cohort study of men between 40 and 80 years of age who underwent PSA screening for PC from 2008 to 2013 in a population-based cohort of privately insured patients. Unadjusted and adjusted rates were calculated using member-years and reported per 1,000 memberyears.
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RESULTS: Rates of PSA screening remained stable from 190.4 per 1,000 member-years in 2008 to 196.4 in 2013 (p=0.66). From 2008 to 2013, PSA screening did not change for patients aged 50-59 (236.5 to 241.1 per 1000 member-years; p=0.78), 60-64 (284.1 to 288.3 per 1,000 member-years; p=0.77), 65-69 (250.6 to 248.0 per 1,000 member-years; p=0.56), and 70-74 (266.4 to 280.3 per 1,000 member-years; p=0.17). However, patients > 75 years had marked decrease in the rate of PSA screening from 201.5 to 124.1 per 1,000 member-years (p=0.04). Across different racial groups, PSA screening rates remain unchanged over time irrespective of age. CONCLUSIONS: Among this population-based cohort of privately insured men, we found little effect on PSA screening from changes to the USPSTF clinical practice guidelines. However, the rates of PSA screening was much lower among older men (>75 years). Further research is needed to assess the impact of the new guidelines on prostate cancer incidence and survival. INTRODUCTION Widespread prostate cancer screening with prostate-specific antigen (PSA) testing has recently become subject of intense debate about the benefits in reducing prostate cancer mortality relative to the harms of overdiagnosis and overtreatment. This controversy is due to the mixed evidence of benefits from the Prostate, Lung, Colorectal and Ovarian (PLCO) and the European Randomized Study of Screening for Prostate Cancer (ERSPC) trials in whether routine PSA and digital rectal exam (DRE) marginally lowered the risks of prostate cancer-specific mortality, or simply exposed patients to unnecessary
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prostate biopsies and overdiagnosis.1-3 As a consequence, patients and providers are confronted with conflicting clinical practice guidelines about whether PSA screening should be routinely performed among men at average risk of developing prostate cancer.4-6 The American Urological Association (AUA) and the American Cancer Society (ACS) endorse shared decision-making for patients to make an informed decision in regards to the merits and harms from routine prostate cancer screening. However, the U.S. Preventive Services Task Force (USPSTF) recently recommended against the routine use of PSA screening and DRE among all men of average risk in 2012.4,6,7
Contemporary trends of PSA screening for early detection of prostate cancer have important implications since prostate cancer remains the most commonly diagnosed male malignancy with more than 200,000 men diagnosed each year in the United States.8 Furthermore, most men diagnosed with clinically localized disease currently receive some form of primary therapy with new advanced treatment technologies (intensity-modulated radiotherapy or robotic surgery) that are associated with higher health care costs.9-12 Previous studies examining the impact of changes in the previous USPSTF recommendations in limiting PSA screening among older patients (>75 years) found little changes among Medicare beneficiaries.13 More recently, however, several studies have suggested that declines in the incidence of localized prostate cancer and PSA screening rates following the change to the guidelines in 2012.14-16 It is essential
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to recognize that all three studies relied on a national cross-sectional survey of patients to assess trends in prostate cancer screening.
Changes in the national screening rates for prostate cancer attributable to the recent changes from USPSTF recommendations against have significant policy implications. At present, prostate cancer screening has been associated with significant health care costs especially considering that the average annual costs to Medicare from prostate cancer screening alone has been estimated at approximately $500 million per year.17 Moreover, most men diagnosed with localized prostate cancer are undergoing primary therapy with new treatment technologies, such as robotic surgery or intensity modulated radiation therapy, that have been shown to have higher health care costs as well.10,12,18,19 Little is known about the impact of these changes to the clinical practice guidelines on PSA testing, in particular among the privately insured patients. Addressing this key knowledge gap is essential in understanding the effects in the dissemination of clinical practice guidelines into clinical practice. Furthermore, it also necessary to investigate other national data to accurately elucidate whether that there has been a reduction in prostate cancer screening. In this context, we sought to identify trends of PSA screening using a national private health insurance database from 2008 to 2013. We also sought to examine patient characteristics associated with PSA screening over time.
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MATERIALS AND METHODS Date Source and Study Sample We conducted a retrospective analysis of data from the Optum Labs Data Warehouse which includes privately insured and Medicare Advantage enrollees in the U.S.20 The database contains longitudinal health information on over 100 million enrollees over the last 20 years, from geographically diverse regions across the U.S (with greatest representation from the South and Midwest). The data includes numerous data domains, including enrollee information (insurance plan, gender, age, dates of eligibility), pharmacy claims (prescribing physician, pharmacy, fill data, days of supply, strength), medical claims (include International Classification of Diseases, 9th Revision, Clinical Modification (ICD9-CM) diagnosis codes, ICD-9 procedure codes, Current Procedural Terminology, Version 4 Common Procedure Terms (CPT-4) procedure codes, Healthcare Common Procedure Coding System (HCPCS) procedure codes, site of service codes, standardized costs and provider specialty codes), laboratory results (test name, LOINC codes, and results), and socioeconomic characteristics (income, net worth, education, race/ethnicity). Because this study involved analysis of pre-existing, de-identified data, it is exempt from Institutional Review Board approval.
To identify the analytic cohort of men undergoing PSA-based screening for prostate cancer, we used a similar claims-based algorithm as described in previous studies.17,21 Patients were included if they met the following inclusion
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criteria:1) Patients aged 40 to 80 years; 2) > 1 outpatient visit; 3) > 1 PSA test performed; and 4) one year of continuous enrollment from January 1, 2008 to December 31, 2013. Using ICD-9 or CPT codes from outpatient and inpatient claims, we excluded patients with a prior history of prostate cancer (ICD-9 185 or V1046), receipt of treatment with radical prostatectomy (ICD-9 60.21, 60.29, 60.3-60.6, 60.61, or 60.62; CPT 55810, 55821, 55831, 55842, 55845), or androgen deprivation therapy (CPT J950, J9202, J9217, J9218, J9219), or history of elevated PSA (ICD-9 790.93). Patients were also excluded from the primary screening cohort also If they had claims consistent with the following symptoms three months prior to the index PSA test: urinary obstruction (ICD-9 599.6), hematuria (ICD-9 599.7), prostatitis (ICD-9 601-601.9), other disorders of the prostate (ICD-9 602-602.9), unexplained weight loss (ICD-9 788.21), or back pain (ICD-9 724.5). From the patient population undergoing primary screening for prostate cancer, the index PSA test was from HCPCS codes (G0103, 84152, 84153, and 84154).
Outcomes and Covariates The primary outcome of this study was PSA testing rates. Sociodemographic variables included patient age, race, household income ranges, census region and division. The Charlson/Deyo comorbidity index was used to assess the patient’s overall baseline comorbidity burden, using ICD-9CM codes to identify the 17 conditions during the baseline period.22 PSA testing
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rates were calculated using member-months and reported per 1,000 memberyears.
Statistical Analysis Data are presented as frequencies and means for all variables. Rates are expressed in member-years per 10,000 (calculated by dividing member-months by 12 and multiplying by 10,000). The overall rate for each year was computed by dividing member-years of those males with at least one PSA test divided by the member-years of all males (age 40-80) enrolled in the given year. Age-, race- and region-specific crude rates are the ratio of the number member-years of PSA tested males to the population of males in each subgroup. Age-, raceand region-adjusted rates were calculated by multiplying the subgroup specific rates by the proportion of the subgroup in our reference population (2008) and then the products were summed. All statistical analyses were performed using SAS software version 9.3 (SAS Institute Inc, Cary, NC).
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RESULTS From 2008 to 2013, we identified 5,225,372 men who underwent PSA screening for prostate cancer in the Optum Labs Data Warehouse. Overall, the mean age was 56.0 years (SD: 8.5). As shown in Table 1, there were minimal differences in the patient characteristics over time. A majority of patients in the analytic cohort were white and between the ages of 40 to 64 years old. In addition, most patients were healthy with few patients having two or more comorbidities based on the Charlson-Deyo index. Overall, our results indicate little changes in the rates of PSA screening from 190.4 in 2008 to 196.4 in 2013 per 1,000 member-years (p=0.66). From 2008 to 2013, we observed little changes in the crude rates of PSA screening for all groups except for older patients (Table 2). Among patients > 75 years old, the crude rate of PSA screening tests fell from 201.5 patients in 2008 to 124.1 patients per 1,000 member years (p=0.04). Crude rates of PSA also remained stable across different racial groups over time. However, patients residing in the Northeast geographic region had a gradual decrease of PSA screening rates, while those living in the South were found to have increase in PSA screening rates (both p<0.05). Table 3 provides the adjusted rates of PSA screening rates per 1,000 member-years by age, race and census region. On multivariable analysis, the results demonstrate that there were minimal changes in the adjusted rates of PSA screening. Overall, the rates adjusted for race, age, comorbidity and
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geographic region did not vary from 190.4 individuals in 2008 to 196.5 individuals per 1,000 member years (p=0.65). Likewise, the age, race, and census region adjusted PSA screening rates remained relatively stable over time from 2008 to 2013.
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DISCUSSION In this population-based cohort study of privately insured patients, we sought to assess the possible impact of the recent Grade D recommendation from the USPSTF on prostate cancer screening at a time when PSA testing has become increasingly controversial due to the growing concerns about overdiagnosis and overtreatment.4,18 Our study has several key findings. First, our results suggest relatively little change in the rates of PSA testing among younger patients (< 70 years old) from 2008 to 2013. At present, there is little consensus among clinical practice guidelines about the role of screening in prostate cancer. In 2012, the USPSTF released new guidelines advising against PSA testing and DRE’s based on a systematic review and meta-analysis finding minimal benefit in reducing cancer-related death and harm from biopsy-related complications and treatment-related quality of life QOL.4,23 In 2010, the ACS released clinical practice guidelines for prostate cancer screening advising that men who have a life expectancy of > 10 years make an informed decision after reviewing the merits of screening and treatment of localized prostate cancer.7 The ACS guidelines are also similar to the current recommendations from the AUA that endorses shared decision-making for patients and providers about prostate screening.6 However, the AUA endorses prostate cancer screening among patients between the ages of 55 to 69 years of age, or a life expectancy < 10 years.
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Against this backdrop, our findings of relatively stable rates of PSA testing for localized prostate cancer differ from several recent studies suggesting lower PSA screening and, as a result, lower incidence of localized prostate cancer.15,16 Previous studies have suggested a modest impact in changes to practice patterns attributable to modifications to clinical practice guidelines or publication of high profile clinical trials. For instance, Zeliaidt et al examined the rates of PSA screening among patients in the Veterans Health Administration finding modest declines of only 3.0% among men between the ages of 40-75 years old from 2004 to 2010 despite the publication of the PLCO and ERSPC trials.2,3,24 Several studies have evaluated the relationship of the 2008 USPTSF changes to clinical practice guidelines that recommended against screening men > 75 years old.25 A study using the National Health Interview Surveys (NHIS) documented that the proportion of men reporting undergoing PSA screening was unchanged at 48% from 2005 to 2010.26 More recently, however, several studies made use of the NHIS and reported lower use of PSA testing for prostate cancer screening. For example, two prominent studies using the NHIS showed identical results in that PSA screening among patients > 50 years old fell from 37.8% in 2010 to 30.8% in 2013.15,16
Our study provides another important source of information about the the contemporary practice patterns in regards to prostate cancer screening in a large privately insured patient population with different results and conclusions. These results are particularly salient since younger patients may benefit from
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screening and treatment for localized prostate cancer.2,27,28 One key explanation about differences from the two recent population-based studies using the NHIS and our results is likely the source of the data. It is essential to recognize that the the NHIS is a national survey of patients with an approximate response rate of 60% rather than actual claims for PSA testing as in our study.14 As a result, selfreporting by patients undergoing prostate cancer screening may be limited due to patient recall bias and error. The results presented here may more accurately capture the rates of PSA testing for prostate cancer screening as a result.
Second, our study also found a significant lowering in PSA screening among older patients (> 75 years) over time. From 2008 to 2013, we found a 38.3% reduction in PSA screening from 201.5 to 124.1 patients per 1,000 member-years. Our study also differs from previous studies assessing changes to PSA screening in older patients who are most likely to be harmed from PSA screening. Recently, Prasad et al also showed a high and stable rate of PSA screening with approximately 40% of men > 75 years old reported undergoing prostate cancer screening when comparing 2005 and 2010 in the National Health Interview Surveys.29 Another population-based cohort study also examined the impact of the USPTSF 2008 recommendations by examining PSA screening among Medicare beneficiaries from 2007 to 2009.30 In this study, however, the rates of PSA screening decreased modestly from 29.4% in 2007 to 27.8% in 2009. Our study shows a continued and significant lowering in the use of PSA screening among men >75 year old. Several possible causes may explain these
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findings. It is plausible that there may in fact be lag in changes in practice patterns following the changes to clinical practice guidelines or publications of high profile clinical trials. Another possible explanation is that PSA screening has become increasingly controversial, where providers and patients recognize the harms from overdiagnosis and overtreatment.
Our study has several limitations. We acknowledge that our study relied on claims data from a single private health insurance payor. It is feasible that the results may not be generalizable to patients covered by different payers. Indeed, one plausible explanation of the minimal changes to PSA screening in our cohort may be that privately insured patients tend to have higher socioeconomic status and education. As a result, patients views towards preventive health care may be different than from studies published examining this issue. Yet, it is essential to recognize that these data captures a nationally representative sample of patients. Another limitation may be that the ascertainment of the PSA testing for prostate cancer relied on a claims-based algorithm. Our study also did not evaluate for the downstream consequences of PSA testing, such as prostate biopsy or use of different primary therapies. Lastly, the time interval of the study may have not allowed enough time for the dissemination of the changes to the prostate cancer screening guidelines to possibly affect PSA screening rates in this population-based cohort.
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CONCLUSIONS In summary, we found little effect of PSA screening from changes to clinical practice guidelines overall except for men with limited life expectancy in this population-based cohort of privately insured men. Despite the mixed results from PLCO and ERSPC trials and the recent controversial grade D recommendation from the USPTSF in 2012, PSA screening rates remained relatively stable for younger patients and across different racial groups. Our results have important policy implications in regards to the changes to PSA screening and the downstream utilizations of prostate cancer treatment and health care costs.9,17,18 Further research is needed in assessing the changes to PSA screening across different patient populations with more contemporary data to critically evaluate whether changes to clinical practice guidelines have influenced prostate cancer screening in the U.S.
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Carter HB, Albertsen PC, Barry MJ, et al. Early Detection of Prostate Cancer: AUA Guideline. J Urol. 2013.
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Wolf AM, Wender RC, Etzioni RB, et al. American Cancer Society guideline for the early detection of prostate cancer: update 2010. CA Cancer J Clin. 2010;60(2):70-98.
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Cooperberg MR, Broering JM, Carroll PR. Time trends and local variation in primary treatment of localized prostate cancer. J Clin Oncol. 2010;28(7):1117-1123.
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Jacobs BL, Zhang Y, Schroeck FR, et al. Use of advanced treatment technologies among men at low risk of dying from prostate cancer. JAMA. 2013;309(24):2587-2595.
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Kim SP, Shah ND, Karnes RJ, et al. Hospitalization costs for radical prostatectomy attributable to robotic surgery. Eur Urol. 2013;64(1):11-16.
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Nguyen PL, Gu X, Lipsitz SR, et al. Cost implications of the rapid adoption of newer technologies for treating prostate cancer. J Clin Oncol. 2011;29(12):1517-1524.
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Ross JS, Wang R, Long JB, Gross CP, Ma X. Impact of the 2008 US Preventive Services Task Force recommendation to discontinue prostate cancer screening among male Medicare beneficiaries. Arch Intern Med. 2012;172(20):1601-1603.
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Li J, Berkowitz Z, Hall IJ. Decrease in Prostate Cancer Testing Following the US Preventive Services Task Force (USPSTF) Recommendations. J Am Board Fam Med. 2015;28(4):491493.
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Jemal A, Fedewa SA, Ma J, et al. Prostate Cancer Incidence and PSA Testing Patterns in Relation to USPSTF Screening Recommendations. JAMA. 2015;314(19):2054-2061.
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Etzioni R, Gulati R. Recent Trends in PSA Testing and Prostate Cancer Incidence: A Look at Context. JAMA Oncol. 2016.
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Ma X, Wang R, Long JB, et al. The cost implications of prostate cancer screening in the Medicare population. Cancer. 2014;120(1):96-102.
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Welch HG, Albertsen PC. Prostate cancer diagnosis and treatment after the introduction of prostate-specific antigen screening: 1986-2005. J Natl Cancer Inst. 2009;101(19):1325-1329.
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Kim SP, Shah ND, Karnes RJ, et al. Hospitalization Costs for Radical Prostatectomy Attributable to Robotic Surgery. Eur Urol. 2012.
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Wallace PJ, Shah ND, Dennen T, Bleicher PA, Crown WH. Optum Labs: building a novel node in the learning health care system. Health affairs. 2014;33(7):1187-1194.
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Walter LC, Bertenthal D, Lindquist K, Konety BR. PSA screening among elderly men with limited life expectancies. JAMA. 2006;296(19):2336-2342.
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Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. Journal of clinical epidemiology. 1992;45(6):613-619.
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Chou R, Croswell JM, Dana T, et al. Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2011;155(11):762-771.
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Zeliadt SB, Hoffman RM, Etzioni R, Gore JL, Kessler LG, Lin DW. Influence of publication of US and European prostate cancer screening trials on PSA testing practices. J Natl Cancer Inst. 2011;103(6):520-523.
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Drazer MW, Prasad SM, Huo D, et al. National trends in prostate cancer screening among older American men with limited 9-year life expectancies: evidence of an increased need for shared decision making. Cancer. 2014;120(10):1491-1498.
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Prasad SM, Drazer MW, Huo D, Hu JC, Eggener SE. 2008 US Preventive Services Task Force recommendations and prostate cancer screening rates. JAMA. 2012;307(16):16921694.
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Ross JS, Wang R, Long JB, Gross CP, Ma X. Impact of the 2008 US Preventive Services Task Force Recommendation to Discontinue Prostate Cancer Screening Among Male Medicare Beneficiaries. Arch Intern Med. 2012:1-3.
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Table 1: Patient Characteristics 2008 (N=810,949)
2009 (N=843,189)
2010 (N=847,985)
2011 (N=893,915)
2012 (N=895,937)
2013 (N=932,397)
Age (years) Mean (SD)
55.7 (8.4)
56.0 (8.5)
56.3 (8.5)
56.7 (8.7)
56.9 (8.7)
57.2 (8.7)
Age groups 40-49 years 50-59 years 60-64 years 65-69 years 70-74 years 75+ years
191676 (23.6%) 363473 (44.8%) 150575 (18.6%) 52482 (6.5%) 26510 (3.3%) 26233 (3.2%)
194022 (23.0%) 372377 (44.2%) 160504 (19.0%) 58086 (6.9%) 29989 (3.6%) 28211 (3.3%)
185484 (21.9%) 367411 (43.3%) 164149 (19.4%) 68171 (8.0%) 38632 (4.6%) 24138 (2.8%)
188408 (21.1%) 381312 (42.7%) 168044 (18.8%) 80807 (9.0%) 47287 (5.3%) 28057 (3.1%)
Charlson index Mean (SD)
0.9 (1.5)
0.9 (1.5)
0.9 (1.5)
0.8 (1.5)
Charlson index 0 1 2 3+
465155 (57.4%) 186677 (23.0%) 69270 (8.5%) 89847 (11.1%)
487020 (57.8%) 191494 (22.7%) 71034 (8.4%) 93641 (11.1%)
489929 (57.8%) 193336 (22.8%) 71452 (8.4%) 93268 (11.0%)
524204 (58.6%) 202436 (22.6%) 72527 (8.1%) 94748 (10.6%)
536539 (59.9%) 612055 (65.6%) 200471 (22.4%) 185284 (19.9%) 70253 (7.8%) 61181 (6.6%) 88674 (9.9%) 73877 (7.9%)
Census region Midwest Northeast South West Unknown/Other
163535 (20.2%) 171643 (21.2%) 359827 (44.4%) 114472 (14.1%) 1472 (0.2%)
167309 (19.8%) 168052 (19.9%) 373769 (44.3%) 132015 (15.7%) 2044 (0.2%)
170117 (20.1%) 157217 (18.5%) 385231 (45.4%) 134845 (15.9%) 575 (0.1%)
181887 (20.3%) 162819 (18.2%) 410321 (45.9%) 138300 (15.5%) 588 (0.1%)
178546 (19.9%) 187655 (20.1%) 172142 (19.2%) 185106 (19.9%) 416170 (46.5%) 429209 (46.0%) 128522 (14.3%) 129812 (13.9%) 557 (0.1%) 615 (0.1%)
181933 (20.3%) 180660 (19.4%) 379798 (42.4%) 394256 (42.3%) 165910 (18.5%) 173250 (18.6%) 86937 (9.7%) 94005 (10.1%) 52115 (5.8%) 58205 (6.2%) 29244 (3.3%) 32021 (3.4%)
0.8 (1.4)
0.7 (1.3)
Race 19
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Asian Black Hispanic White Unknown/missing
24456 (3.0%) 48523 (6.0%) 47496 (5.9%) 435828 (53.7%) 254646 (31.4%)
26960 (3.2%) 52032 (6.2%) 54596 (6.5%) 452684 (53.7%) 256917 (30.5%)
28120 (3.3%) 53924 (6.4%) 53557 (6.3%) 464821 (54.8%) 247563 (29.2%)
29608 (3.3%) 57521 (6.4%) 56775 (6.4%) 488293 (54.6%) 261718 (29.3%)
29108 (3.2%) 29727 (3.2%) 57040 (6.4%) 56838 (6.1%) 56510 (6.3%) 58066 (6.2%) 480952 (53.7%) 494260 (53.0%) 272327 (30.4%) 293506 (31.5%)
Household income range Unknown/missing < $40K $40K - $49K $50K - $59K $60K - $74K $75K - $99K $100K+
259075 (31.9%) 69797 (8.6%) 57937 (7.1%) 60521 (7.5%) 80372 (9.9%) 113648 (14.0%) 169599 (20.9%)
262996 (31.2%) 75200 (8.9%) 61851 (7.3%) 64470 (7.6%) 85306 (10.1%) 119061 (14.1%) 174305 (20.7%)
255945 (30.2%) 78746 (9.3%) 62091 (7.3%) 65160 (7.7%) 86514 (10.2%) 120051 (14.2%) 179478 (21.2%)
274040 (30.7%) 84377 (9.4%) 63825 (7.1%) 66811 (7.5%) 88509 (9.9%) 123647 (13.8%) 192706 (21.6%)
289781 (32.3%) 311287 (33.4%) 81704 (9.1%) 66083 (7.1%) 60433 (6.7%) 43914 (4.7%) 62766 (7.0%) 48043 (5.2%) 83912 (9.4%) 70080 (7.5%) 118603 (13.2%) 108811 (11.7%) 198738 (22.2%) 284179 (30.5%)
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Table 2: Crude rates of PSA testing for prostate cancer screening per 1,000 member-years Covariate Overall
2008 190.4
2009 197.9
2010 197.1
2011 199.0
2012 192.3
2013 196.4
p-value 0.66
Age (years) 40-49 50-59 60-64 65-69 70-74 > 75
108.6 236.5 284.1 250.6 266.4 201.5
115.8 247.8 295.0 234.3 234.0 165.7
114.5 247.0 296.4 240.0 247.3 118.0
113.2 245.0 293.0 258.1 281.2 128.2
107.9 236.0 283.8 248.1 278.8 121.7
109.1 241.1 288.3 248.0 280.0 124.1
0.49 0.78 0.77 0.56 0.17 0.04
White Black Hispanic Asian Unknown
194.5 190.5 161.1 203.9 188.9
198.4 197.9 187.3 221.4 197.3
199.2 201.9 187.2 225.8 191.9
204.6 210.4 191.8 225.6 186.4
198.0 205.8 186.6 208.8 180.3
201.6 202.2 185.0 201.1 189.0
0.18 0.11 0.22 0.63 0.28
Census Region Northeast Midwest South West Unknown
241.6 165.0 203.9 142.2 122.7
241.1 166.5 208.7 172.2 107.7
222.1 164.2 213.6 179.1 101.1
207.9 168.3 218.5 186.5 103.4
207.7 155.5 216.5 170.5 102.6
218.1 157.5 222.8 167.0 91.5
0.05 0.12 0.002 0.37 0.02
Race
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Table 3: Adjusted rates of PSA testing for prostate cancer screening per 1,000 member-years (reference population=2008) Overall Age-adjusted Race-adjusted Census region- adjusted
2008 190.4 190.4 190.6 190.4
2009 197.9 196.2 198.1 198.0
2010 197.1 194.6 197.1 197.2
2011 199.0 194.9 199.1 198.9
2012 199.2 187.6 192.6 192.2
2013 196.4 190.6 196.7 196.4
p-value 0.65 0.43 0.63 0.67
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Back into the pre-PSA era
Joachim Noldus, MD Department of Urology, Ruhr-University Bochum, Marien Hospital Herne, Herne, Germany
No conflicts of interest
Corresponding address Dr. Joachim Noldus, MD, Head of Department Department of Urology Ruhr-University Bochum, Marien Hospital Herne Hölkeskampring 40 44625 Herne, Germany Tel 0049-2323-499-2301 Fax 0049-2323-499-3385 Email [email protected]
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After introduction of PSA into clinical routine in the early ‘80s of the last century, we noticed a steady decline in PCa mortality. A large European screening program confirmed this trend (1). However, the contemporaneous publication of the US Prostate, Lung, Colorectal, and Ovarian (PLCO) screening cancer trial could not confirm this benefit. Screened and non-screened had similar not significantly different low death rate from prostate cancer after 7 to 10 years of follow-up (2). After the grade D recommendation of the USPSTF, which was substantially based on these data (2), PSA screening is no longer advised for any US men at any age (3). As a result of this recommendation, recent data showed a decline in PCa incidence for low, intermediate, and high-risk disease, beginning in October 2011 (4). The authors found a steep monthly decline in prostate cancer incidence of 166 cases or minus 12.2% following the USPSTF recommendation. Specifically, the data showed a 23.1% and 28.1% decline in intermediated and high-risk prostate cancer, respectively. In this issue of the Gold Journal, the authors investigated the “Contemporarily national trends of prostate cancer screening among privately insured men in the United States”. Notably, according to the Kaiser Family Foundation, 49 to 54% of men in the US are privately insured (5). Interestingly and in contrast to Barocas et al. (4), they did not find statistically different screening rates between 2008 and 2013 among privately insured men in the ages of 50-59, 60-64, and 65-69 and for different racial groups. They only noticed a decline in the screening rate for men 75 years of age and older. Comparing these results with the ones of Barocas et al. (4) one might suspect of a two-classed society, or is it just an issue of data acquiring? What can we expect from these data in the next decades? Strictly obeying the grade D recommendation of the USPSTF might result in deleterious cancer stages for patients with intermediate and high-risk disease. Efforts are needed to identify men who require a PSA screening
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and who do not, outweighing the benefit over the harms of PCa treatment by reducing the overtreatment for very low and low risk disease. One can hope that the USPSTF will change their recommendation in the future due to the recently revised data of the PLCO trial (6). In particular, the analyses of the data show a contamination of the control arm, the men who should not have had a PSA drawn, of close to 90%. One solution out of this dilemma could be at least one PSA measurement for men in their midlife to identify those with potential lethal prostate cancer (7).
References 1. Schroder FH, Hugosson J, Roobol MJ, et al. Screening and moratlity-rate in a randomized european study. N Engl J Med. 2009;360:1320-8 2. Andriole GL, Crawford ED, Grubb III RL, et al. Mortality rates from a randomized prostatecancer screening trail. N Engl J Med. 2009;360:1310-9 3. Chou R, Croswell JM, Dana T, et al. Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2011;155:762-71. doi: 10.7326/0003-4819-155-11-201112060-00375. Epub 2011 Oct 7PMID: 21984740. 4. Barocas DA, Mallin K, Graves AJ, et al. Effect of the USPSTF Grade D Recommendation against Screening for Prostate Cancer on Incident Prostate Cancer Diagnoses in the United States. J Urol 2015;194:1587-93. doi: 10.1016/j.juro.2015.06.075. Epub 2015 Jun 15. PMID: 26087383. 5. http://kff.org/other/state-indicator/total-population/ 6. Shoag JE, Hu JC. Reevaluating PSA testing rates in the PLCO trial. N Engl J Med 2016;374:1795-6
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7. Preston MA, Batista JL, Wilson KM, et al. Baseline Prostate-Specific Antigen Levels in Midlife Predict Lethal Prostate Cancer. JCO 2016; Jun 13. pii: JCO667527. [Epub ahead of print]
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EDITORIAL RESPONSE
Simon P. Kim, MD, MPH Assistant Professor of Urologic Oncology and Urology Co-director for the Center of Health Outcomes and Quality University Hospital Case Medical Center Case Western Reserve University School of Medicine Seidman Cancer Center 11100 Euclid Avenue Lakeside Building Suite 4954 Mailstop LKS 5046 Cleveland, Ohio 44106 E-mail: [email protected] Fax: 216-844-1900 DISCLOSURES: Dr. Simon P. Kim was supported from a career development award through the Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO) and the Rapport Trust.
We appreciate the insightful editorial that accompanied our study examining the contemporary trends of PSA screening in a population-based cohort of privately insured patients. There is perhaps no more an important public health question in urology than the possible impact of the United States Preventive Service Task Force (USPSTF) on the burden of prostate cancer among men.1
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Addressing this question is critical since it is essential to acknowledge that prostate cancer remains the 2nd leading cause of cancer mortality in the U.S.2 The downstream consequences of the Grade D recommendation may either lower overdiagnosis and unnecessary treatment for indolent disease, increase incidence of locally advanced or metastatic prostate cancer and cancer-related mortality, or lead to no changes in practice patterns of primary care providers about use of PSA screening and DRE. A recent population-based study using SEER suggested marked reductions in PSA screening and localized prostate cancer incidence in the wake of the Grade D recommendation.3
Nonetheless, assessing other patient populations about changes to practice patterns is needed. Our study found that there was minimal short-term impact in light of the recent changes to clinical practice guidelines, in particular amongst younger men who may represent the patient population that benefits from PSA screening. It remains to be seen whether these change to prostate cancer screening and diagnoses will affect the most important patient-centered outcome—cancer related mortality. However, it is unlikely that the controversy regarding the benefits and harms of prostate cancer screening will end, especially considering the recent study raising concerns about the study quality from the PLCO trial with the PSA screening exposure in the control arm than previously reported.4
Furthermore, there is no other prostate cancer screening test readily available to
supplant PSA screening at this time. If the PSA screening is indeed lower which is attributable to the Grade D recommendation resulting in lower incidence of prostate cancer, it is possible that we may be introducing harm with more men presenting with metastatic prostate cancer and dying from this common malignancy.5 Continuing research effort is needed to critically evaluate whether such drastic changes to clinical practice guidelines is beneficial or harmful for our patients.
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REFERENCES 1.
Moyer VA, Force USPST. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157(2):120-134.
2.
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66(1):7-30.
3.
Jemal A, Fedewa SA, Ma J, et al. Prostate Cancer Incidence and PSA Testing Patterns in Relation to USPSTF Screening Recommendations. JAMA. 2015;314(19):2054-2061.
4.
Shoag JE, Mittal S, Hu JC. Reevaluating PSA Testing Rates in the PLCO Trial. N Engl J Med. 2016;374(18):1795-1796.
5.
Welch HG, Gorski DH, Albertsen PC. Trends in Metastatic Breast and Prostate Cancer-Lessons in Cancer Dynamics. N Engl J Med. 2015;373(18):1685-1687.
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S0090-4295(16)30512-X http://dx.doi.org/doi: 10.1016/j.urology.2016.06.067 URL 19965
To appear in:
Urology
Received date: Accepted date:
10-4-2016 14-6-2016
Please cite this article as: Simon P. Kim, R. Jeffrey Karnes, Cary P. Gross, Neal J. Meropol, Holly Van Houten, Robert Abouassaly, Nilay D. Shah, Contemporary National Trends of Prostate Cancer Screening among Privately Insured Men in the United States, Urology (2016), http://dx.doi.org/doi: 10.1016/j.urology.2016.06.067. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
CONTEMPORARY NATIONAL TRENDS OF PROSTATE CANCER SCREENING AMONG PRIVATELY INSURED MEN IN THE UNITED STATES
Simon P. Kim, MD, MPH1-3; R. Jeffrey Karnes, MD4; Cary P. Gross, MD3,5; Neal J. Meropol, MD2; Holly Van Houten, BA6; Robert Abouassaly, MD, MS1,2; Nilay D. Shah, PhD6,7 1
University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Urology Institute, Center for Quality and Outcomes, Cleveland, Ohio 2 University Hospitals Case Medical Center, Seidman Cancer Center, Case Western Comprehensive Cancer Center, Cleveland, Ohio 3 Yale University, Cancer Outcomes, Public Policy and Effectiveness Research (COPPER) Center, New Haven, Connecticut 4 Mayo Clinic, Department of Urology, Rochester, Minnesota 5 Yale University, Department of Internal Medicine, New Haven, Connecticut 6 Mayo Clinic, Division of Health Care Policy and Research, Rochester, Minnesota 7 Mayo Clinic, Knowledge and Evaluation Research (KER) Unit, Rochester, Minnesota Correspondence:
Simon P. Kim, MD, MPH University Hospitals Case Medical Center Case Western Reserve University Medical School Urology Institute Center for Quality and Outcomes 11000 Euclid Avenue Lakeside Building Suite 4954 Mailstop LKS 5046 Cleveland, Ohio 44106 E-mail: [email protected] Fax: 216-844-1900
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Conflict of Interest: None Support/Financial Disclosure: Dr. Simon P. Kim is supported through a career development award from the Conquer Cancer Foundation of the American Cancer Society Career Development Award. Manuscript Word Count: 2,413 Abstract Word Count: 246 Tables: 3 Figures: 0 Appendices: 0 References: 30 Key Words: Prostate Cancer, PSA, Clinical Practice Guidelines ABSTRACT OBJECTIVES: To assess the possible impact of changes to the clinical guidelines from U.S. Preventive Service Task Force (USPSTF) recommendations in 2012 on the national trends of PSA screening and identify patient characteristics associated with PSA screening from a large private insurance database. METHODS: We conducted a retrospective cohort study of men between 40 and 80 years of age who underwent PSA screening for PC from 2008 to 2013 in a population-based cohort of privately insured patients. Unadjusted and adjusted rates were calculated using member-years and reported per 1,000 memberyears.
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RESULTS: Rates of PSA screening remained stable from 190.4 per 1,000 member-years in 2008 to 196.4 in 2013 (p=0.66). From 2008 to 2013, PSA screening did not change for patients aged 50-59 (236.5 to 241.1 per 1000 member-years; p=0.78), 60-64 (284.1 to 288.3 per 1,000 member-years; p=0.77), 65-69 (250.6 to 248.0 per 1,000 member-years; p=0.56), and 70-74 (266.4 to 280.3 per 1,000 member-years; p=0.17). However, patients > 75 years had marked decrease in the rate of PSA screening from 201.5 to 124.1 per 1,000 member-years (p=0.04). Across different racial groups, PSA screening rates remain unchanged over time irrespective of age. CONCLUSIONS: Among this population-based cohort of privately insured men, we found little effect on PSA screening from changes to the USPSTF clinical practice guidelines. However, the rates of PSA screening was much lower among older men (>75 years). Further research is needed to assess the impact of the new guidelines on prostate cancer incidence and survival. INTRODUCTION Widespread prostate cancer screening with prostate-specific antigen (PSA) testing has recently become subject of intense debate about the benefits in reducing prostate cancer mortality relative to the harms of overdiagnosis and overtreatment. This controversy is due to the mixed evidence of benefits from the Prostate, Lung, Colorectal and Ovarian (PLCO) and the European Randomized Study of Screening for Prostate Cancer (ERSPC) trials in whether routine PSA and digital rectal exam (DRE) marginally lowered the risks of prostate cancer-specific mortality, or simply exposed patients to unnecessary
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prostate biopsies and overdiagnosis.1-3 As a consequence, patients and providers are confronted with conflicting clinical practice guidelines about whether PSA screening should be routinely performed among men at average risk of developing prostate cancer.4-6 The American Urological Association (AUA) and the American Cancer Society (ACS) endorse shared decision-making for patients to make an informed decision in regards to the merits and harms from routine prostate cancer screening. However, the U.S. Preventive Services Task Force (USPSTF) recently recommended against the routine use of PSA screening and DRE among all men of average risk in 2012.4,6,7
Contemporary trends of PSA screening for early detection of prostate cancer have important implications since prostate cancer remains the most commonly diagnosed male malignancy with more than 200,000 men diagnosed each year in the United States.8 Furthermore, most men diagnosed with clinically localized disease currently receive some form of primary therapy with new advanced treatment technologies (intensity-modulated radiotherapy or robotic surgery) that are associated with higher health care costs.9-12 Previous studies examining the impact of changes in the previous USPSTF recommendations in limiting PSA screening among older patients (>75 years) found little changes among Medicare beneficiaries.13 More recently, however, several studies have suggested that declines in the incidence of localized prostate cancer and PSA screening rates following the change to the guidelines in 2012.14-16 It is essential
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to recognize that all three studies relied on a national cross-sectional survey of patients to assess trends in prostate cancer screening.
Changes in the national screening rates for prostate cancer attributable to the recent changes from USPSTF recommendations against have significant policy implications. At present, prostate cancer screening has been associated with significant health care costs especially considering that the average annual costs to Medicare from prostate cancer screening alone has been estimated at approximately $500 million per year.17 Moreover, most men diagnosed with localized prostate cancer are undergoing primary therapy with new treatment technologies, such as robotic surgery or intensity modulated radiation therapy, that have been shown to have higher health care costs as well.10,12,18,19 Little is known about the impact of these changes to the clinical practice guidelines on PSA testing, in particular among the privately insured patients. Addressing this key knowledge gap is essential in understanding the effects in the dissemination of clinical practice guidelines into clinical practice. Furthermore, it also necessary to investigate other national data to accurately elucidate whether that there has been a reduction in prostate cancer screening. In this context, we sought to identify trends of PSA screening using a national private health insurance database from 2008 to 2013. We also sought to examine patient characteristics associated with PSA screening over time.
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MATERIALS AND METHODS Date Source and Study Sample We conducted a retrospective analysis of data from the Optum Labs Data Warehouse which includes privately insured and Medicare Advantage enrollees in the U.S.20 The database contains longitudinal health information on over 100 million enrollees over the last 20 years, from geographically diverse regions across the U.S (with greatest representation from the South and Midwest). The data includes numerous data domains, including enrollee information (insurance plan, gender, age, dates of eligibility), pharmacy claims (prescribing physician, pharmacy, fill data, days of supply, strength), medical claims (include International Classification of Diseases, 9th Revision, Clinical Modification (ICD9-CM) diagnosis codes, ICD-9 procedure codes, Current Procedural Terminology, Version 4 Common Procedure Terms (CPT-4) procedure codes, Healthcare Common Procedure Coding System (HCPCS) procedure codes, site of service codes, standardized costs and provider specialty codes), laboratory results (test name, LOINC codes, and results), and socioeconomic characteristics (income, net worth, education, race/ethnicity). Because this study involved analysis of pre-existing, de-identified data, it is exempt from Institutional Review Board approval.
To identify the analytic cohort of men undergoing PSA-based screening for prostate cancer, we used a similar claims-based algorithm as described in previous studies.17,21 Patients were included if they met the following inclusion
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criteria:1) Patients aged 40 to 80 years; 2) > 1 outpatient visit; 3) > 1 PSA test performed; and 4) one year of continuous enrollment from January 1, 2008 to December 31, 2013. Using ICD-9 or CPT codes from outpatient and inpatient claims, we excluded patients with a prior history of prostate cancer (ICD-9 185 or V1046), receipt of treatment with radical prostatectomy (ICD-9 60.21, 60.29, 60.3-60.6, 60.61, or 60.62; CPT 55810, 55821, 55831, 55842, 55845), or androgen deprivation therapy (CPT J950, J9202, J9217, J9218, J9219), or history of elevated PSA (ICD-9 790.93). Patients were also excluded from the primary screening cohort also If they had claims consistent with the following symptoms three months prior to the index PSA test: urinary obstruction (ICD-9 599.6), hematuria (ICD-9 599.7), prostatitis (ICD-9 601-601.9), other disorders of the prostate (ICD-9 602-602.9), unexplained weight loss (ICD-9 788.21), or back pain (ICD-9 724.5). From the patient population undergoing primary screening for prostate cancer, the index PSA test was from HCPCS codes (G0103, 84152, 84153, and 84154).
Outcomes and Covariates The primary outcome of this study was PSA testing rates. Sociodemographic variables included patient age, race, household income ranges, census region and division. The Charlson/Deyo comorbidity index was used to assess the patient’s overall baseline comorbidity burden, using ICD-9CM codes to identify the 17 conditions during the baseline period.22 PSA testing
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rates were calculated using member-months and reported per 1,000 memberyears.
Statistical Analysis Data are presented as frequencies and means for all variables. Rates are expressed in member-years per 10,000 (calculated by dividing member-months by 12 and multiplying by 10,000). The overall rate for each year was computed by dividing member-years of those males with at least one PSA test divided by the member-years of all males (age 40-80) enrolled in the given year. Age-, race- and region-specific crude rates are the ratio of the number member-years of PSA tested males to the population of males in each subgroup. Age-, raceand region-adjusted rates were calculated by multiplying the subgroup specific rates by the proportion of the subgroup in our reference population (2008) and then the products were summed. All statistical analyses were performed using SAS software version 9.3 (SAS Institute Inc, Cary, NC).
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RESULTS From 2008 to 2013, we identified 5,225,372 men who underwent PSA screening for prostate cancer in the Optum Labs Data Warehouse. Overall, the mean age was 56.0 years (SD: 8.5). As shown in Table 1, there were minimal differences in the patient characteristics over time. A majority of patients in the analytic cohort were white and between the ages of 40 to 64 years old. In addition, most patients were healthy with few patients having two or more comorbidities based on the Charlson-Deyo index. Overall, our results indicate little changes in the rates of PSA screening from 190.4 in 2008 to 196.4 in 2013 per 1,000 member-years (p=0.66). From 2008 to 2013, we observed little changes in the crude rates of PSA screening for all groups except for older patients (Table 2). Among patients > 75 years old, the crude rate of PSA screening tests fell from 201.5 patients in 2008 to 124.1 patients per 1,000 member years (p=0.04). Crude rates of PSA also remained stable across different racial groups over time. However, patients residing in the Northeast geographic region had a gradual decrease of PSA screening rates, while those living in the South were found to have increase in PSA screening rates (both p<0.05). Table 3 provides the adjusted rates of PSA screening rates per 1,000 member-years by age, race and census region. On multivariable analysis, the results demonstrate that there were minimal changes in the adjusted rates of PSA screening. Overall, the rates adjusted for race, age, comorbidity and
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geographic region did not vary from 190.4 individuals in 2008 to 196.5 individuals per 1,000 member years (p=0.65). Likewise, the age, race, and census region adjusted PSA screening rates remained relatively stable over time from 2008 to 2013.
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DISCUSSION In this population-based cohort study of privately insured patients, we sought to assess the possible impact of the recent Grade D recommendation from the USPSTF on prostate cancer screening at a time when PSA testing has become increasingly controversial due to the growing concerns about overdiagnosis and overtreatment.4,18 Our study has several key findings. First, our results suggest relatively little change in the rates of PSA testing among younger patients (< 70 years old) from 2008 to 2013. At present, there is little consensus among clinical practice guidelines about the role of screening in prostate cancer. In 2012, the USPSTF released new guidelines advising against PSA testing and DRE’s based on a systematic review and meta-analysis finding minimal benefit in reducing cancer-related death and harm from biopsy-related complications and treatment-related quality of life QOL.4,23 In 2010, the ACS released clinical practice guidelines for prostate cancer screening advising that men who have a life expectancy of > 10 years make an informed decision after reviewing the merits of screening and treatment of localized prostate cancer.7 The ACS guidelines are also similar to the current recommendations from the AUA that endorses shared decision-making for patients and providers about prostate screening.6 However, the AUA endorses prostate cancer screening among patients between the ages of 55 to 69 years of age, or a life expectancy < 10 years.
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Against this backdrop, our findings of relatively stable rates of PSA testing for localized prostate cancer differ from several recent studies suggesting lower PSA screening and, as a result, lower incidence of localized prostate cancer.15,16 Previous studies have suggested a modest impact in changes to practice patterns attributable to modifications to clinical practice guidelines or publication of high profile clinical trials. For instance, Zeliaidt et al examined the rates of PSA screening among patients in the Veterans Health Administration finding modest declines of only 3.0% among men between the ages of 40-75 years old from 2004 to 2010 despite the publication of the PLCO and ERSPC trials.2,3,24 Several studies have evaluated the relationship of the 2008 USPTSF changes to clinical practice guidelines that recommended against screening men > 75 years old.25 A study using the National Health Interview Surveys (NHIS) documented that the proportion of men reporting undergoing PSA screening was unchanged at 48% from 2005 to 2010.26 More recently, however, several studies made use of the NHIS and reported lower use of PSA testing for prostate cancer screening. For example, two prominent studies using the NHIS showed identical results in that PSA screening among patients > 50 years old fell from 37.8% in 2010 to 30.8% in 2013.15,16
Our study provides another important source of information about the the contemporary practice patterns in regards to prostate cancer screening in a large privately insured patient population with different results and conclusions. These results are particularly salient since younger patients may benefit from
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screening and treatment for localized prostate cancer.2,27,28 One key explanation about differences from the two recent population-based studies using the NHIS and our results is likely the source of the data. It is essential to recognize that the the NHIS is a national survey of patients with an approximate response rate of 60% rather than actual claims for PSA testing as in our study.14 As a result, selfreporting by patients undergoing prostate cancer screening may be limited due to patient recall bias and error. The results presented here may more accurately capture the rates of PSA testing for prostate cancer screening as a result.
Second, our study also found a significant lowering in PSA screening among older patients (> 75 years) over time. From 2008 to 2013, we found a 38.3% reduction in PSA screening from 201.5 to 124.1 patients per 1,000 member-years. Our study also differs from previous studies assessing changes to PSA screening in older patients who are most likely to be harmed from PSA screening. Recently, Prasad et al also showed a high and stable rate of PSA screening with approximately 40% of men > 75 years old reported undergoing prostate cancer screening when comparing 2005 and 2010 in the National Health Interview Surveys.29 Another population-based cohort study also examined the impact of the USPTSF 2008 recommendations by examining PSA screening among Medicare beneficiaries from 2007 to 2009.30 In this study, however, the rates of PSA screening decreased modestly from 29.4% in 2007 to 27.8% in 2009. Our study shows a continued and significant lowering in the use of PSA screening among men >75 year old. Several possible causes may explain these
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findings. It is plausible that there may in fact be lag in changes in practice patterns following the changes to clinical practice guidelines or publications of high profile clinical trials. Another possible explanation is that PSA screening has become increasingly controversial, where providers and patients recognize the harms from overdiagnosis and overtreatment.
Our study has several limitations. We acknowledge that our study relied on claims data from a single private health insurance payor. It is feasible that the results may not be generalizable to patients covered by different payers. Indeed, one plausible explanation of the minimal changes to PSA screening in our cohort may be that privately insured patients tend to have higher socioeconomic status and education. As a result, patients views towards preventive health care may be different than from studies published examining this issue. Yet, it is essential to recognize that these data captures a nationally representative sample of patients. Another limitation may be that the ascertainment of the PSA testing for prostate cancer relied on a claims-based algorithm. Our study also did not evaluate for the downstream consequences of PSA testing, such as prostate biopsy or use of different primary therapies. Lastly, the time interval of the study may have not allowed enough time for the dissemination of the changes to the prostate cancer screening guidelines to possibly affect PSA screening rates in this population-based cohort.
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CONCLUSIONS In summary, we found little effect of PSA screening from changes to clinical practice guidelines overall except for men with limited life expectancy in this population-based cohort of privately insured men. Despite the mixed results from PLCO and ERSPC trials and the recent controversial grade D recommendation from the USPTSF in 2012, PSA screening rates remained relatively stable for younger patients and across different racial groups. Our results have important policy implications in regards to the changes to PSA screening and the downstream utilizations of prostate cancer treatment and health care costs.9,17,18 Further research is needed in assessing the changes to PSA screening across different patient populations with more contemporary data to critically evaluate whether changes to clinical practice guidelines have influenced prostate cancer screening in the U.S.
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Schroder FH, Hugosson J, Roobol MJ, et al. Prostate-cancer mortality at 11 years of follow-up. N Engl J Med. 2012;366(11):981-990.
2.
Schroder FH, Hugosson J, Roobol MJ, et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med. 2009;360(13):1320-1328.
3.
Andriole GL, Crawford ED, Grubb RL, 3rd, et al. Mortality results from a randomized prostatecancer screening trial. N Engl J Med. 2009;360(13):1310-1319.
4.
Moyer VA. Screening for Prostate Cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2012;157(2):120-134.
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Kawachi MH, Bahnson RR, Barry M, et al. NCCN clinical practice guidelines in oncology: prostate cancer early detection. J Natl Compr Canc Netw. 2010;8(2):240-262.
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Carter HB, Albertsen PC, Barry MJ, et al. Early Detection of Prostate Cancer: AUA Guideline. J Urol. 2013.
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Wolf AM, Wender RC, Etzioni RB, et al. American Cancer Society guideline for the early detection of prostate cancer: update 2010. CA Cancer J Clin. 2010;60(2):70-98.
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Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014;64(1):9-29.
9.
Cooperberg MR, Broering JM, Carroll PR. Time trends and local variation in primary treatment of localized prostate cancer. J Clin Oncol. 2010;28(7):1117-1123.
10.
Jacobs BL, Zhang Y, Schroeck FR, et al. Use of advanced treatment technologies among men at low risk of dying from prostate cancer. JAMA. 2013;309(24):2587-2595.
11.
Kim SP, Shah ND, Karnes RJ, et al. Hospitalization costs for radical prostatectomy attributable to robotic surgery. Eur Urol. 2013;64(1):11-16.
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12.
Nguyen PL, Gu X, Lipsitz SR, et al. Cost implications of the rapid adoption of newer technologies for treating prostate cancer. J Clin Oncol. 2011;29(12):1517-1524.
13.
Ross JS, Wang R, Long JB, Gross CP, Ma X. Impact of the 2008 US Preventive Services Task Force recommendation to discontinue prostate cancer screening among male Medicare beneficiaries. Arch Intern Med. 2012;172(20):1601-1603.
14.
Li J, Berkowitz Z, Hall IJ. Decrease in Prostate Cancer Testing Following the US Preventive Services Task Force (USPSTF) Recommendations. J Am Board Fam Med. 2015;28(4):491493.
15.
Jemal A, Fedewa SA, Ma J, et al. Prostate Cancer Incidence and PSA Testing Patterns in Relation to USPSTF Screening Recommendations. JAMA. 2015;314(19):2054-2061.
16.
Etzioni R, Gulati R. Recent Trends in PSA Testing and Prostate Cancer Incidence: A Look at Context. JAMA Oncol. 2016.
17.
Ma X, Wang R, Long JB, et al. The cost implications of prostate cancer screening in the Medicare population. Cancer. 2014;120(1):96-102.
18.
Welch HG, Albertsen PC. Prostate cancer diagnosis and treatment after the introduction of prostate-specific antigen screening: 1986-2005. J Natl Cancer Inst. 2009;101(19):1325-1329.
19.
Kim SP, Shah ND, Karnes RJ, et al. Hospitalization Costs for Radical Prostatectomy Attributable to Robotic Surgery. Eur Urol. 2012.
20.
Wallace PJ, Shah ND, Dennen T, Bleicher PA, Crown WH. Optum Labs: building a novel node in the learning health care system. Health affairs. 2014;33(7):1187-1194.
21.
Walter LC, Bertenthal D, Lindquist K, Konety BR. PSA screening among elderly men with limited life expectancies. JAMA. 2006;296(19):2336-2342.
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22.
Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. Journal of clinical epidemiology. 1992;45(6):613-619.
23.
Chou R, Croswell JM, Dana T, et al. Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2011;155(11):762-771.
24.
Zeliadt SB, Hoffman RM, Etzioni R, Gore JL, Kessler LG, Lin DW. Influence of publication of US and European prostate cancer screening trials on PSA testing practices. J Natl Cancer Inst. 2011;103(6):520-523.
25.
Force USPST. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2008;149(3):185-191.
26.
Drazer MW, Prasad SM, Huo D, et al. National trends in prostate cancer screening among older American men with limited 9-year life expectancies: evidence of an increased need for shared decision making. Cancer. 2014;120(10):1491-1498.
27.
Bill-Axelson A, Holmberg L, Ruutu M, et al. Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med. 2011;364(18):1708-1717.
28.
Bill-Axelson A, Holmberg L, Ruutu M, et al. Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med. 2005;352(19):1977-1984.
29.
Prasad SM, Drazer MW, Huo D, Hu JC, Eggener SE. 2008 US Preventive Services Task Force recommendations and prostate cancer screening rates. JAMA. 2012;307(16):16921694.
30.
Ross JS, Wang R, Long JB, Gross CP, Ma X. Impact of the 2008 US Preventive Services Task Force Recommendation to Discontinue Prostate Cancer Screening Among Male Medicare Beneficiaries. Arch Intern Med. 2012:1-3.
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Table 1: Patient Characteristics 2008 (N=810,949)
2009 (N=843,189)
2010 (N=847,985)
2011 (N=893,915)
2012 (N=895,937)
2013 (N=932,397)
Age (years) Mean (SD)
55.7 (8.4)
56.0 (8.5)
56.3 (8.5)
56.7 (8.7)
56.9 (8.7)
57.2 (8.7)
Age groups 40-49 years 50-59 years 60-64 years 65-69 years 70-74 years 75+ years
191676 (23.6%) 363473 (44.8%) 150575 (18.6%) 52482 (6.5%) 26510 (3.3%) 26233 (3.2%)
194022 (23.0%) 372377 (44.2%) 160504 (19.0%) 58086 (6.9%) 29989 (3.6%) 28211 (3.3%)
185484 (21.9%) 367411 (43.3%) 164149 (19.4%) 68171 (8.0%) 38632 (4.6%) 24138 (2.8%)
188408 (21.1%) 381312 (42.7%) 168044 (18.8%) 80807 (9.0%) 47287 (5.3%) 28057 (3.1%)
Charlson index Mean (SD)
0.9 (1.5)
0.9 (1.5)
0.9 (1.5)
0.8 (1.5)
Charlson index 0 1 2 3+
465155 (57.4%) 186677 (23.0%) 69270 (8.5%) 89847 (11.1%)
487020 (57.8%) 191494 (22.7%) 71034 (8.4%) 93641 (11.1%)
489929 (57.8%) 193336 (22.8%) 71452 (8.4%) 93268 (11.0%)
524204 (58.6%) 202436 (22.6%) 72527 (8.1%) 94748 (10.6%)
536539 (59.9%) 612055 (65.6%) 200471 (22.4%) 185284 (19.9%) 70253 (7.8%) 61181 (6.6%) 88674 (9.9%) 73877 (7.9%)
Census region Midwest Northeast South West Unknown/Other
163535 (20.2%) 171643 (21.2%) 359827 (44.4%) 114472 (14.1%) 1472 (0.2%)
167309 (19.8%) 168052 (19.9%) 373769 (44.3%) 132015 (15.7%) 2044 (0.2%)
170117 (20.1%) 157217 (18.5%) 385231 (45.4%) 134845 (15.9%) 575 (0.1%)
181887 (20.3%) 162819 (18.2%) 410321 (45.9%) 138300 (15.5%) 588 (0.1%)
178546 (19.9%) 187655 (20.1%) 172142 (19.2%) 185106 (19.9%) 416170 (46.5%) 429209 (46.0%) 128522 (14.3%) 129812 (13.9%) 557 (0.1%) 615 (0.1%)
181933 (20.3%) 180660 (19.4%) 379798 (42.4%) 394256 (42.3%) 165910 (18.5%) 173250 (18.6%) 86937 (9.7%) 94005 (10.1%) 52115 (5.8%) 58205 (6.2%) 29244 (3.3%) 32021 (3.4%)
0.8 (1.4)
0.7 (1.3)
Race 19
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Asian Black Hispanic White Unknown/missing
24456 (3.0%) 48523 (6.0%) 47496 (5.9%) 435828 (53.7%) 254646 (31.4%)
26960 (3.2%) 52032 (6.2%) 54596 (6.5%) 452684 (53.7%) 256917 (30.5%)
28120 (3.3%) 53924 (6.4%) 53557 (6.3%) 464821 (54.8%) 247563 (29.2%)
29608 (3.3%) 57521 (6.4%) 56775 (6.4%) 488293 (54.6%) 261718 (29.3%)
29108 (3.2%) 29727 (3.2%) 57040 (6.4%) 56838 (6.1%) 56510 (6.3%) 58066 (6.2%) 480952 (53.7%) 494260 (53.0%) 272327 (30.4%) 293506 (31.5%)
Household income range Unknown/missing < $40K $40K - $49K $50K - $59K $60K - $74K $75K - $99K $100K+
259075 (31.9%) 69797 (8.6%) 57937 (7.1%) 60521 (7.5%) 80372 (9.9%) 113648 (14.0%) 169599 (20.9%)
262996 (31.2%) 75200 (8.9%) 61851 (7.3%) 64470 (7.6%) 85306 (10.1%) 119061 (14.1%) 174305 (20.7%)
255945 (30.2%) 78746 (9.3%) 62091 (7.3%) 65160 (7.7%) 86514 (10.2%) 120051 (14.2%) 179478 (21.2%)
274040 (30.7%) 84377 (9.4%) 63825 (7.1%) 66811 (7.5%) 88509 (9.9%) 123647 (13.8%) 192706 (21.6%)
289781 (32.3%) 311287 (33.4%) 81704 (9.1%) 66083 (7.1%) 60433 (6.7%) 43914 (4.7%) 62766 (7.0%) 48043 (5.2%) 83912 (9.4%) 70080 (7.5%) 118603 (13.2%) 108811 (11.7%) 198738 (22.2%) 284179 (30.5%)
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Table 2: Crude rates of PSA testing for prostate cancer screening per 1,000 member-years Covariate Overall
2008 190.4
2009 197.9
2010 197.1
2011 199.0
2012 192.3
2013 196.4
p-value 0.66
Age (years) 40-49 50-59 60-64 65-69 70-74 > 75
108.6 236.5 284.1 250.6 266.4 201.5
115.8 247.8 295.0 234.3 234.0 165.7
114.5 247.0 296.4 240.0 247.3 118.0
113.2 245.0 293.0 258.1 281.2 128.2
107.9 236.0 283.8 248.1 278.8 121.7
109.1 241.1 288.3 248.0 280.0 124.1
0.49 0.78 0.77 0.56 0.17 0.04
White Black Hispanic Asian Unknown
194.5 190.5 161.1 203.9 188.9
198.4 197.9 187.3 221.4 197.3
199.2 201.9 187.2 225.8 191.9
204.6 210.4 191.8 225.6 186.4
198.0 205.8 186.6 208.8 180.3
201.6 202.2 185.0 201.1 189.0
0.18 0.11 0.22 0.63 0.28
Census Region Northeast Midwest South West Unknown
241.6 165.0 203.9 142.2 122.7
241.1 166.5 208.7 172.2 107.7
222.1 164.2 213.6 179.1 101.1
207.9 168.3 218.5 186.5 103.4
207.7 155.5 216.5 170.5 102.6
218.1 157.5 222.8 167.0 91.5
0.05 0.12 0.002 0.37 0.02
Race
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Table 3: Adjusted rates of PSA testing for prostate cancer screening per 1,000 member-years (reference population=2008) Overall Age-adjusted Race-adjusted Census region- adjusted
2008 190.4 190.4 190.6 190.4
2009 197.9 196.2 198.1 198.0
2010 197.1 194.6 197.1 197.2
2011 199.0 194.9 199.1 198.9
2012 199.2 187.6 192.6 192.2
2013 196.4 190.6 196.7 196.4
p-value 0.65 0.43 0.63 0.67
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Back into the pre-PSA era
Joachim Noldus, MD Department of Urology, Ruhr-University Bochum, Marien Hospital Herne, Herne, Germany
No conflicts of interest
Corresponding address Dr. Joachim Noldus, MD, Head of Department Department of Urology Ruhr-University Bochum, Marien Hospital Herne Hölkeskampring 40 44625 Herne, Germany Tel 0049-2323-499-2301 Fax 0049-2323-499-3385 Email [email protected]
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After introduction of PSA into clinical routine in the early ‘80s of the last century, we noticed a steady decline in PCa mortality. A large European screening program confirmed this trend (1). However, the contemporaneous publication of the US Prostate, Lung, Colorectal, and Ovarian (PLCO) screening cancer trial could not confirm this benefit. Screened and non-screened had similar not significantly different low death rate from prostate cancer after 7 to 10 years of follow-up (2). After the grade D recommendation of the USPSTF, which was substantially based on these data (2), PSA screening is no longer advised for any US men at any age (3). As a result of this recommendation, recent data showed a decline in PCa incidence for low, intermediate, and high-risk disease, beginning in October 2011 (4). The authors found a steep monthly decline in prostate cancer incidence of 166 cases or minus 12.2% following the USPSTF recommendation. Specifically, the data showed a 23.1% and 28.1% decline in intermediated and high-risk prostate cancer, respectively. In this issue of the Gold Journal, the authors investigated the “Contemporarily national trends of prostate cancer screening among privately insured men in the United States”. Notably, according to the Kaiser Family Foundation, 49 to 54% of men in the US are privately insured (5). Interestingly and in contrast to Barocas et al. (4), they did not find statistically different screening rates between 2008 and 2013 among privately insured men in the ages of 50-59, 60-64, and 65-69 and for different racial groups. They only noticed a decline in the screening rate for men 75 years of age and older. Comparing these results with the ones of Barocas et al. (4) one might suspect of a two-classed society, or is it just an issue of data acquiring? What can we expect from these data in the next decades? Strictly obeying the grade D recommendation of the USPSTF might result in deleterious cancer stages for patients with intermediate and high-risk disease. Efforts are needed to identify men who require a PSA screening
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and who do not, outweighing the benefit over the harms of PCa treatment by reducing the overtreatment for very low and low risk disease. One can hope that the USPSTF will change their recommendation in the future due to the recently revised data of the PLCO trial (6). In particular, the analyses of the data show a contamination of the control arm, the men who should not have had a PSA drawn, of close to 90%. One solution out of this dilemma could be at least one PSA measurement for men in their midlife to identify those with potential lethal prostate cancer (7).
References 1. Schroder FH, Hugosson J, Roobol MJ, et al. Screening and moratlity-rate in a randomized european study. N Engl J Med. 2009;360:1320-8 2. Andriole GL, Crawford ED, Grubb III RL, et al. Mortality rates from a randomized prostatecancer screening trail. N Engl J Med. 2009;360:1310-9 3. Chou R, Croswell JM, Dana T, et al. Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2011;155:762-71. doi: 10.7326/0003-4819-155-11-201112060-00375. Epub 2011 Oct 7PMID: 21984740. 4. Barocas DA, Mallin K, Graves AJ, et al. Effect of the USPSTF Grade D Recommendation against Screening for Prostate Cancer on Incident Prostate Cancer Diagnoses in the United States. J Urol 2015;194:1587-93. doi: 10.1016/j.juro.2015.06.075. Epub 2015 Jun 15. PMID: 26087383. 5. http://kff.org/other/state-indicator/total-population/ 6. Shoag JE, Hu JC. Reevaluating PSA testing rates in the PLCO trial. N Engl J Med 2016;374:1795-6
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7. Preston MA, Batista JL, Wilson KM, et al. Baseline Prostate-Specific Antigen Levels in Midlife Predict Lethal Prostate Cancer. JCO 2016; Jun 13. pii: JCO667527. [Epub ahead of print]
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EDITORIAL RESPONSE
Simon P. Kim, MD, MPH Assistant Professor of Urologic Oncology and Urology Co-director for the Center of Health Outcomes and Quality University Hospital Case Medical Center Case Western Reserve University School of Medicine Seidman Cancer Center 11100 Euclid Avenue Lakeside Building Suite 4954 Mailstop LKS 5046 Cleveland, Ohio 44106 E-mail: [email protected] Fax: 216-844-1900 DISCLOSURES: Dr. Simon P. Kim was supported from a career development award through the Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO) and the Rapport Trust.
We appreciate the insightful editorial that accompanied our study examining the contemporary trends of PSA screening in a population-based cohort of privately insured patients. There is perhaps no more an important public health question in urology than the possible impact of the United States Preventive Service Task Force (USPSTF) on the burden of prostate cancer among men.1
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Addressing this question is critical since it is essential to acknowledge that prostate cancer remains the 2nd leading cause of cancer mortality in the U.S.2 The downstream consequences of the Grade D recommendation may either lower overdiagnosis and unnecessary treatment for indolent disease, increase incidence of locally advanced or metastatic prostate cancer and cancer-related mortality, or lead to no changes in practice patterns of primary care providers about use of PSA screening and DRE. A recent population-based study using SEER suggested marked reductions in PSA screening and localized prostate cancer incidence in the wake of the Grade D recommendation.3
Nonetheless, assessing other patient populations about changes to practice patterns is needed. Our study found that there was minimal short-term impact in light of the recent changes to clinical practice guidelines, in particular amongst younger men who may represent the patient population that benefits from PSA screening. It remains to be seen whether these change to prostate cancer screening and diagnoses will affect the most important patient-centered outcome—cancer related mortality. However, it is unlikely that the controversy regarding the benefits and harms of prostate cancer screening will end, especially considering the recent study raising concerns about the study quality from the PLCO trial with the PSA screening exposure in the control arm than previously reported.4
Furthermore, there is no other prostate cancer screening test readily available to
supplant PSA screening at this time. If the PSA screening is indeed lower which is attributable to the Grade D recommendation resulting in lower incidence of prostate cancer, it is possible that we may be introducing harm with more men presenting with metastatic prostate cancer and dying from this common malignancy.5 Continuing research effort is needed to critically evaluate whether such drastic changes to clinical practice guidelines is beneficial or harmful for our patients.
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REFERENCES 1.
Moyer VA, Force USPST. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157(2):120-134.
2.
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66(1):7-30.
3.
Jemal A, Fedewa SA, Ma J, et al. Prostate Cancer Incidence and PSA Testing Patterns in Relation to USPSTF Screening Recommendations. JAMA. 2015;314(19):2054-2061.
4.
Shoag JE, Mittal S, Hu JC. Reevaluating PSA Testing Rates in the PLCO Trial. N Engl J Med. 2016;374(18):1795-1796.
5.
Welch HG, Gorski DH, Albertsen PC. Trends in Metastatic Breast and Prostate Cancer-Lessons in Cancer Dynamics. N Engl J Med. 2015;373(18):1685-1687.
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