Editorials
The 2001 ASCCP Management Guidelines for Cervical Cytology
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1905.
Shortly after the National Cancer Institute's Bethesda 2001 meeting to modify cervical cytologic terminology,1 the American Society for Colposcopy and Cervical Pathology (ASCCP)2 developed evidence-based guidelines for the management of abnormal cervical cytologic results. These guidelines are presented in this issue of American Family Physician,3 and a simplified algorithm-based version of the recommendations is available online at http://www.asccp.org.4 All physicians who perform cervical cancer screening should implement these recommendations, which now are considered the standard of care. Guidelines for managing histologically confirmed cervical intraepithelial neoplasia (CIN) also were developed for health care providers who perform colposcopy and relevant surgical interventions.5
The ASCCP cytologic guidelines specifically considered management of low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), atypical glandular cells (AGC), and atypical squamous cells (ASC, subcategorized into ASC of undetermined significance [ASC-US] and ASC that cannot exclude a high-grade intraepithelial lesion [ASC-H]).
Women with changes less severe than ASC generally do not require colposcopy. However, women with ASC-H or more severe results (i.e., LSIL, HSIL, AGC, cancer) should be examined by colposcopy. Postmenopausal, adolescent, and pregnant women may be managed more conservatively.
Several options are available for women with ASC-US, which may be evaluated in one of three ways. If the Papanicolaou (Pap) test was collected using liquid-based cytology, reflex testing of residual cells using a test for 13 types of high-risk human papillomavirus (HPV) DNA is the preferred management option (Hybrid Capture 2 High-Risk HPV DNA test, Digene Corp., Gaithersburg, Md.).6,7 Women with a positive high-risk HPV DNA test result should be evaluated with colposcopy.
Two important points about HPV DNA testing must be understood. First, the low-risk DNA test should not be used for clinical triage of women with ASC-US. This test is designed to detect nononcogenic HPV types and therefore has no utility as a triage test for CIN. Second, the high-risk test should not be used to determine how cytologic abnormalities more severe than ASC-US should be managed. Because the majority of women with LSIL or more severe cytologic changes are infected with high-risk HPV DNA types, there is no need to use the HPV DNA test to determine if a patient is at increased risk for significant neoplasia.
Colposcopy is an acceptable management option in women with ASC-US because approximately 25 percent of these women will have a cervical neoplasia. Serially repeated Pap tests also are an acceptable form of follow-up in women with ASC-US. If a repeat Pap test detects ASC-US or a more severe cytologic change, the patient should be examined by colposcopy. Serial cytologic evaluation is less robust than using a test for high-risk HPV DNA or colposcopy. Consequently, it is questionable whether serial cytologic testing will remain an acceptable option in future management guidelines.
In the past, some women were monitored after colposcopy by serial cytologic testing or cytologic testing combined with colposcopy. Several new follow-up approaches are now recommended. In women with minor cytologic changes, only two negative Pap test results are required before patients can return to a routine testing interval. Because of the more ominous nature of glandular lesions, women with AGC must have four negative follow-up cytologic test results before resuming routine Pap testing. Women with ASC-US, ASC-H, and LSIL results and no evidence of cervical neoplasia following colposcopic examination may have repeat cytology at six and 12 months or testing for high-risk HPV DNA in 12 months. The latter approach minimizes patient follow-up and allows time for regression of HPV-related lesions. Persistent HPV infection is a significant risk for the development of CIN. Because the HPV DNA test has a high negative predictive value (approximately 99 percent), a negative high-risk HPV DNA test result offers reassurance that the patient does not have a significant cervical neoplasia (CIN grade 3 or greater).
The management of AGC is vastly different from that of ASC. Although both diagnoses refer to "atypical" cells, women with AGC must have a more aggressive evaluation with colposcopy, endocervical sampling and, in some cases, endometrial biopsy. Because of the more inaccessible nature of glandular (columnar) cells within the endocervical canal and the colposcopic subtlety of these inconspicuous lesions, only experts should attempt to manage possible glandular neoplasia.
Additional educational information may be obtained from the ASCCP (telephone: 800-787-7227; Web site: http://www.asccp.org).
The Author
Daron G. Ferris, M.D., is president of the American Society for Colposcopy and Cervical Pathology (ASCCP), program director of the ASCCP's Comprehensive Colposcopy courses, and professor of family medicine and obstetrics and gynecology at the Medical College of Georgia in Augusta. Dr. Ferris served on the Low-Grade Squamous Intraepithelial Lesions Committee for the 2001 ASCCP management guidelines.
Address correspondence to Daron G. Ferris, M.D., Medical College of Georgia, 1423 Harper St., HH-105, Augusta, GA 30912-3500 (email: dferris@mcg.edu). Reprints are not available from the author.
REFERENCES
1. Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, et al. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA 2002;287:2114-9.
2. Wright TC Jr, Cox JT, Massad LS, Twiggs LB, Wilkinson EJ. 2001 Consensus Guidelines for the management of women with cervical cytological abnormalities. JAMA 2002;287:2120-9.
3. Apgar BS, Brotzman G. Management of cervical cytologic abnormalities. Am Fam Physician 2004;70:1905-16.
4. Wright TC Jr, Cox JT, Massad LS, Twiggs LB, Wilkinson EJ. 2001 Consensus guidelines for the management of women with cervical cytological abnormalities. J Lower Genital Tract Dis 2002;6:127-43.
5. Wright TC Jr, Cox JT, Massad LS, Carlson J, Twiggs LB, Wilkinson EJ. 2001 Consensus Guidelines for the management of women with cervical intraepithelial neoplasia. Am J Obstet Gynecol 2003;189:295-304.
6. Solomon D, Schiffman M, Tarone R. Comparison of three management strategies for patients with atypical squamous cells of undetermined significance: baseline results from a randomized trial. J Natl Cancer Inst 2001;93:293-9.
7. Wright TC Jr, Lorincz A, Ferris DG, Richart RM, Ferenczy A, Mielzynska I, et al. Reflex human papillomavirus deoxyribonucleic acid testing in women with abnormal Papanicolaou smears. Am J Obstet Gynecol 1998;178:962-6.
Overcoming the Challenges Facing Quality-Improvement Strategies for Non-ST-Segment Elevation Acute Coronary Syndromes
MATTHEW T. ROE, M.D., M.H.S., and
ERIC D. PETERSON, M.D., M.P.H.
E. MAGNUS OHMAN, M.D., and
SIDNEY C. SMITH, JR., M.D.
W. BRIAN GIBLER, M.D.
The diagnostic and therapeutic approach to patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS - unstable angina and non-ST-segment elevation myocardial infarction) has evolved considerably over the past decade with publication of multiple landmark trials that have redefined the care of these patients and continual updating of the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the management of NSTE ACS.1-6 Despite these achievements, treatment patterns for these syndromes remain suboptimal.3,7 Quality-improvement efforts are therefore needed to promote increased adherence to the ACC/AHA guidelines and overcome challenges that limit the use of beneficial therapies for NSTE ACS.3
The first challenge involves accurately identifying patients with NSTE ACS from the much larger population of patients who present to emergency departments with suspected ischemic symptoms. Whereas patients with acute ST-segment elevation myocardial infarction usually present with clear chest pain symptoms and often are identified rapidly from the initial electrocardiogram (ECG), patients with NSTE ACS often do not have definitive symptoms or clear ischemic ECG changes on presentation.8,9 Thus, determination of risk status for patients with NSTE myocardial infarction relies heavily on documentation of elevated cardiac biomarkers such as troponins, but interpretation of troponin results often is uncertain in clinical practice given limitations of the available troponin assays and disagreements on what level of troponin elevation should be used to guide therapeutic decision making.10-12
The second challenge involves promoting practice guideline recommendations among all specialties that typically care for patients with NSTE ACS. A recent analysis demonstrated that almost one half of high-risk patients with NSTE ACS in U.S. hospitals are cared for by non-cardiologists who use guideline-recommended therapies and interventions less frequently than cardiologists.13 Similar disparities in care by specialty have been demonstrated in patients with acute myocardial infarction or congestive heart failure.14,15 Explanations for differential care patterns by specialty have not been defined clearly, but may relate to the availability of cardiology services and invasive procedures (especially at community hospitals), poor cooperation among specialties, and inadequate dissemination of guideline recommendations to non-cardiology specialties. Therefore, improved collaboration among specialties is needed to increase adherence to guidelines.
The third challenge involves defining and demonstrating success with quality-improvement efforts. Achievable benchmarks of care such as thresholds for ideal use of aspirin and heparin (designated by treatment patterns at hospitals that have the highest adherence to practice guidelines) have been used as performance indicators to successfully motivate changes in practice. However, benchmarks for the use of medications and procedures are difficult to delineate given uncertainties about contraindications to specific therapies and disagreement among physicians about the benefits of certain medications.16 Results from quality-improvement studies often are questioned because of methodologic limitations that restrict the applicability of the findings to diverse practice environments.17 Nonetheless, key components to successful quality-improvement efforts appear to include developing a consensus about the goals of interventions, administrative support, leadership from physician champions, and regular performance feedback.18 There is no "right" formula for quality improvement, but sustained enthusiasm and flexibility regarding performance improvement approaches may be the best starting points.
Despite the challenges of improving the quality of care for patients with NSTE ACS, there should be a strong impetus for changing current practice patterns because improved performance is associated with a lower risk of mortality.19-22 Specifically, in the ongoing Can Rapid Risk Stratification of Unstable Angina Patients Suppress ADverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) national quality-improvement initiative involving more than 400 hospitals in the United States, in-hospital mortality rates were almost 50 percent lower in hospitals with the best overall adherence to the ACC/AHA guidelines for NSTE ACS compared with hospitals that had the worst adherence to guidelines.22 Therefore, multidisciplinary quality-improvement strategies are needed to promote use of these guidelines, ensuring sustained improvements in care.
The Authors
MATTHEW T. ROE, M.D., M.H.S., is assistant professor of medicine in the Division of Cardiology at Duke University Medical Center and Duke Clinical Research Institute, Durham, N.C.
ERIC D. PETERSON, M.D., M.P.H., is associated professor of medicine in the Division of Cardiology at Duke University Medical Center and Duke Clinical Research Institute, Durham, N.C.
E. MAGNUS OHMAN, M.D., is professor of medicine and chairman of the Division of Cardiology at the University of North Carolina School of Medicine in Chapel Hill, N.C.
SIDNEY C. SMITH, JR., M.D., is professor of medicine in the Division of Cardiology at the University of North Carolina School of Medicine in Chapel Hill, N.C.
W. BRIAN GIBLER, M.D., is professor of emergency medicine and chair of the Department of Emergency Medicine at the University of Cincinnati School of Medicine, Cincinnati, Ohio.
Address correspondence to Matthew T. Roe, M.D., M.H.S., Duke Clinical Research Institute, 2400 Pratt St., Durham, NC 27705 (e-mail: roe00001@mc.duke.edu). Reprints are not available from the authors.
REFERENCES
1. Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, et al. ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: executive summary and recommendations. A report of the American College of Cardiology/American Heart Association task force on practice guidelines (committee on the management of patients with unstable angina) [published correction appears in Circulation 2000;102:1739]. Circulation 2000;102:1193-209.
2. Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, et al. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction-summary article: report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on Management of Patients with Unstable Angina). J Am Coll Cardiol 2002;40:1366-74.
3. Roe MT, Ohman EM, Pollack CV Jr, Peterson ED, Brindis RG, Harrington RA, et al. Changing the model of care for patients with acute coronary syndromes. Am Heart J 2003;146:605-12.
4. Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. N Engl J Med 1998;339:436-43.
5. Cannon CP, Weintraub WS, Demopoulos LA, Vicari R, Frey MJ, Lakkis N, et al. Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban. N Engl J Med 2001;344:1879-87.
6. Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation [published correction appears in N Engl J Med 2001;345:1716]. N Engl J Med 2001;345:494-502.
7. Fox KA, Goodman SG, Klein W, Breiger D, Steg PG, Dabbous O, et al. Management of acute coronary syndromes. Variations in practice and outcome; findings from the Global Registry of Acute Coronary Events (GRACE). Eur Heart J 2002;23:1177-89.
8. Ohman EM, Granger CB, Harrington RA, Lee KL. Risk stratification and therapeutic decision making in acute coronary syndromes. JAMA 2000;284:876-8.
9. Kontos MC, Jesse RL. Evaluation of the emergency department chest pain patient. Am J Cardiol 2000;85:32B-39B.
10. Hamm CW. Cardiac biomarkers for rapid evaluation of chest pain. Circulation 2001;104:1454-6.
11. Jaffe AS, Ravkilde J, Roberts R, Naslund U, Apple FS, Galvani M, et al. It's time for a change to a troponin standard. Circulation 2000;102:1216-20.
12. Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined-a consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction [published correction appears in J Am Coll Cardiol 2001;37:973]. J Am Coll Cardiol 2000;36:959-69.
13. Peterson ED, Roe MT, Li Y, Harrington RA, Brindis RG, Smith SC Jr, et al. Influence of physician specialty on care and outcomes of acute coronary syndrome patients: results from CRUSADE. Abstract presented at American College of Cardiology Scientific Sessions 2003. J Am Coll Cardiol 2003;41:534A.
14. Jollis JG, DeLong ER, Peterson ED, Muhlbaier LH, Fortin DF, Califf RM, et al. Outcome of acute myocardial infarction according to the specialty of the admitting physician. N Engl J Med 1996;335:1880-7.
15. Havranek EP, Wolfe P, Masoudi FA, Rathore SS, Krumholz HM, Ordin DL. Provider and hospital characteristics associated with geographic variation in the evaluation and management of elderly patients with heart failure. Arch Intern Med 2004;164:1186-91.
16. Kiefe CI, Allison JJ, Williams OD, Person SD, Weaver MT, Weissman NW. Improving quality improvement using achievable benchmarks for physician feedback: a randomized controlled trial. JAMA 2001;285:2871-9.
17. Krumholz HM, Herrin J. Quality improvement studies: the need is there but so are the challenges. Am J Med 2000;109:501-3.
18. Bradley EH, Holmboe ES, Mattera JA, Roumanis SA, Radford MJ, Krumholz HM. A qualitative study of increasing beta-blocker use after myocardial infarction: why do some hospitals succeed? JAMA 2001;285:2604-11.
19. Giugliano RP, Lloyd-Jones DM, Camargo CA Jr, Makary MA, O'Donnell CJ. Association of unstable angina guideline care with improved survival. Arch Intern Med 2000;160:1775-80.
20. Allen LA, O'Donnell CJ, Guigliano RP, Camargo CA Jr, Lloyd-Jones DM. Care concordant with guidelines predicts decreased long-term mortality in patients with unstable angina pectoris and non-ST-elevation myocardial infarction. Am J Cardiol 2004;93:1218-22.
21. Mukherjee D, Fang J, Chetcuti S, Moscucci M, Kline-Rogers E, Eagle KA. Impact of combination evidence-based medical therapy on mortality in patients with acute coronary syndromes. Circulation 2004;109:745-9.
22. Peterson ED, Roe MT, Lytle BL, Newby LK, Fraulo ES, Gibler WB, et al. The association between care and outcomes in patients with acute coronary syndromes: national results from CRUSADE. Abstract presented at American College of Cardiology Scientific Sessions 2004. J Am Coll Cardiol 2004;43:406A.
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