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2006 Consensus Guidelines for the Management of.1

2006 Consensus Guidelines for the Management of.1

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estas son las guias consensuadas para el amnejo de la citología alterada, propuestas por la ASCCP en el año 2007.Y si ,en ingles...
estas son las guias consensuadas para el amnejo de la citología alterada, propuestas por la ASCCP en el año 2007.Y si ,en ingles...

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02/13/2013

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Copyright @ 200
7
American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
2006 Consensus Guidelines for theManagement of Women WithAbnormal Cervical Screening Tests
Thomas C. Wright Jr., MD,
1
L. Stewart Massad, MD,
2
Charles J. Dunton, MD,
3
Mark Spitzer, MD,
4
Edward J. Wilkinson, MD,
5
and Diane Solomon, MD;
6
for the 2006 ASCCP-Sponsored Consensus Conference
1
Department of Pathology, College of Physicians and Surgeons of Columbia University,New York, NY,
2
Department of Obstetrics and Gynecology, Washington University School of Medicine, St Louis, MO,
3
Department of Obstetrics and Gynecology, Lankenau Hospital,Wynnewood, PA,
4
Department of Obstetrics and Gynecology, Brookdale University Hospital and Medical Center, Brooklyn, NY,
5
Department of Pathology, University of FloridaCollege of Medicine, Gainesville, FL, and 
6
National Institutes of Health and National Cancer Institute, Bethesda, MD
h
Abstract
Objective.
To provide revised evidence-based consen-sus guidelines for managing women with abnormalcervical cancer screening test results.
Participants.
A group of 146 experts, including repre-sentatives from 29 professional organizations, federalagencies, and national and international health organiza-tions, met in Bethesda, MD, September 18
 Y 
19, 2006, todevelop the guidelines.
Major Changes in Guidelines.
The core recommenda-tions for managing women with atypical squamous cellsof undetermined significance and low-grade squamousintraepithelial lesions were changed minimally. Postcol-poscopy management for women with these cytologicalabnormalities is now identical. Management recommen-dations for these conditions did change for ‘‘specialpopulations,’’ such as adolescents for whom a more con-servative approach incorporating cytological follow-upfor 2 years was approved. Core recommendations formanaging women with high-grade squamous intra-epithelial lesions and atypical glandular cells also under-went only minor modifications. More emphasis is placedon immediate ‘‘screen-and-treat’approaches whenmanaging women with high-grade squamous intra-epithelial lesion. Testing for high-risk human papilloma-virus DNA is incorporated into the management ofwomen with atypical glandular cells after their initialevaluation with colposcopy and endometrial sampling.The 2004 Interim Guidance for the use of humanpapillomavirus DNA testing as an adjunct to cervicalcytology for screening in women 30 years and older wasformally adopted with only very minor modifications.
Conclusions.
The 2006 Consensus Guidelines reflectrecent data from large clinical trials and advances intechnology and are designed to assist clinicians of allsubspecialties.
h
Key Words:
atypical squamous cells of undeterminedsignificance (ASC-US), low-grade squamous intraepitheliallesion, high-grade squamous intraepithelial lesion, cervicalcytology, human papillomavirus (HPV) testing, cervicalcancer screening
I
n 2001, the American Society for Colposcopy andCervical Pathology (ASCCP) joined other professional
Reprint requests to: Thomas C. Wright Jr., MD, Room 16-404, P&SBuilding, 630 W 168th St, New York, NY 10032. E-mail: tcw1@columbia.eduThese evidenced-based consensus guidelines are designed to assistclinicians of all subspecialties in managing women with abnormal cervicalcancer screening tests. These guidelines were developed with funding fromthe American Society for Colposcopy and Cervical Pathology and theNational Cancer Institute. Its contents are solely the responsibility of theauthors and the American Society for Colposcopy and Cervical Pathologyand do not necessarily represent the official views of the National CancerInstitute.
Ó
2007, American Society for Colposcopy and Cervical Pathology
 Journal of Lower Genital Tract Disease, Volume 11, Number 4, 2007, 201
 Y 
222
 
Copyright @ 200
7
American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
societies and federal and international organizations todevelop the 2001 Consensus Guidelines for ManagingWomen with Cytological Abnormalities [1]. Thesewere comprehensive evidenced-based guidelines devel-oped to help clinicians of all subspecialties manage theapproximately 4.8 million women who are diagnosedwith cytological abnormalities annually in the UnitedStates [2]. Before the introduction of the 2001Consensus Guidelines, recommendations for managingwomen with cytological abnormalities varied consider-ably between different professional societies andgovernment agencies. However, because most societiesand organizations that deal with cytological screeningparticipated in the development of the 2001 ConsensusGuidelines, their introduction has led to considerableharmonization of management recommendations inthe United States.Since 2001, new information has become available,including the key follow-up results from the ASCUS/ LSIL Triage Study (ALTS), sponsored by the NationalCancer Institute [3, 4]. Moreover, molecular testingfor high-risk types of human papillomavirus (HPV)has been approved for use with cervical cytology forscreening in women 30 years and older. Although‘interim guidance’for the use of HPV DNA testingin the screening setting was proposed in 2004,recommendations for how to manage combinationsof HPV DNA and Pap test results have not formallybeen evaluated by a large multidisciplinary group [5].In addition, implementation of the 2001 guidelines ina variety of clinical settings made apparent the needfor changes in a number of areas. This pertainsparticularly to ‘special populations’’ such as adoles-cents and postmenopausal women. Finally, there wasalso a desire to streamline the guidelines and makethem more user-friendly. Therefore, in 2005, theASCCP, together with its partner professional socie-ties and federal and international organizations (listedin Appendix A), began the process of revising theguidelines. This culminated in the 2006 ConsensusConference that was held at the National Institutes of Health in September 2006. This report provides therecommendations developed for managing womenwith cytological abnormalities. Recommendations formanaging women with cervical intraepithelial neopla-sia (CIN) and adenocarcinoma in situ (AIS) will bepublished separately. A more comprehensive discus-sion of the recommendations and their supportingevidence will be made available on the ASCCPwebsite (http://www.asccp.org/consensus.shtml).
GUIDELINE DEVELOPMENT PROCESS
The process used to develop the 2006 ConsensusGuidelineswassimilartothatforthepreviousguidelines[1]. Approximately 12 months before the conference, 6working groups were formed, incorporating leaders incervical cancer prevention. Groups identified problemareas in the 2001 guidelines and formulated questionsthat were posted on an open Internet bulletin board fordiscussion among the screening and reproductive healthcommunities. At the same time, the working groupsconducted MEDLINE searches of the English-languagearticles published since 2000. Abstracts were reviewedfor relevance, and relevant articles were reviewed forvalidity and generalizability. Based on Internet discus-sions and literature reviews, draft guidelines weredeveloped and posted on the Internet bulletin boardsfor public comment as well as discussed during con-ference calls among the committee members. Afterfurther revision, guidelines and supporting data werepresented,discussed,modifiedifnecessary,andvotedonat the consensus conference. All guidelines wereapproved by at least a two-thirds majority vote.Cervical cytological abnormalities are managed byclinicians of many specialties, some of whom spend onlya limited amount of time dealing with gynecologicconditions. Therefore, the 2006 Consensus Guidelinesmirror the 2001 Consensus Guidelines for situationswhere new information does not necessitate change. Tomaintain consistency, the terminology used in the newguidelines is identical to that which was used previously,as is the 2-part rating system (Table 1) [1]. The terms
recommended 
,
preferred 
,
acceptable
, and
unacceptable
are used in the guidelines to describe various interven-tions. For example, in some clinical situations, there aremultiple management options that have reasonableevidence of efficacy, but based on less-defined issuessuch as costs or patient convenience, one approach maybe ‘preferred.’The letters A through E are used toindicate‘strengthofrecommendation’fororagainsttheuse of a particular option. The strength of the recom-mendation is based on consideration of several criteria,including potential for harm if an intervention did notoccur,potentialcomplicationsofagivenintervention,aswell asthe ‘‘quality ofthe evidence.’Therefore, anexactcorrelation does not exist between ‘strength of therecommendation’and the ‘quality of the evidence.’‘Quality of evidence’was designated using RomannumeralsItoIIIasdefinedinTable1.Anumberoftermsthatareusedintheguidelineswerespecificallydefinedatthe beginning of the Consensus Conference (Table 1).202
&
WRIGHT ET AL.
 
Copyright @ 200
7
American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
These include the terms
recommended 
,
preferred 
,
acceptable
, and
unacceptable
.
2006 CONSENSUS GUIDELINES
General Comments
Although the guidelines are based on evidence wheneverpossible, for certain clinical situations, there is limitedhigh-quality evidence, and in these situations, theguidelines have, by necessity, been based on consensusexpert opinion. Acceptable management strategiesprovide what the participants considered an acceptablelevel of risk of failing to detect high-grade neoplasia orcancer in a given clinical situation. It is unreasonable forpatients or clinicians to expect that this risk can bereduced to zero, and attempts to achieve zero risk couldresult in greater harm than good, including overtreat-ment. It is also important to recognize that theseguidelines should never substitute for clinical judgment.Clinical judgment should always be used when applyinga guideline to an individual patient because it isimpossible to develop guidelines that apply to allsituations.The 2001 Bethesda System terminology is used forcytological classification [6]. This terminology uses theterms
low-grade squamous intraepithelial lesion
(LSIL)and
high-grade squamous intraepithelial lesion
(HSIL)to refer to low-grade lesions and high-grade cervicalcancer precursors, respectively. The histological classi-fication used is a 2-tiered system that applies the termsCIN 1 to low-grade lesions and CIN 2,3 to high-gradeprecursors. It is important to note that cytological LSILis not equivalent to histological CIN 1 and cytologicalHSIL is not equivalent to histological CIN 2,3. Algo-rithms detailing thedifferentmanagementrecommenda-tions are available at the ASCCP website (http:// www.asccp.org/consensus.shtml). A glossary of termsused in the guidelines is in Appendix B.There are several important points with respect tomanagement strategies in general, and HPV DNAtesting and colposcopy in particular, that apply when-ever these modalities are recommended. Triage usingeither HPV testing or a program of repeat cytology isgenerally not considered an acceptable option if 75% ormore of women tested would be referred to colposcopybecause of a positive result. The current guidelinesexpand clinical indications for HPV testing based onstudies using validated HPVassays. One cannot assumethat management decisions that are based on results of HPV tests that have not been similarly validated willresult in the outcomes that are intended by theseguidelines. Instead, doing so may increase the potentialforpatientharm.Theappropriateuseoftheseguidelinesrequires that laboratories use only HPV tests that havebeen analytically and clinically validated with provenacceptablereproducibility,clinicalsensitivity,specificity,and positive and negative predictive values for cervicalcancer and verified precancer (CIN 2,3), as documentedby Food and Drug Administration (FDA) approval and/ or publication in peer-reviewed scientific literature. It isalso important to stress that testing should be restrictedto high-risk (oncogenic) HPV types (i.e., 16, 18, 31, 33,35, 39, 45, 51, 52, 56, 58, 59, and 66) [7]. Testing forlow-risk (nononcogenic) HPV types has no role in theevaluation of women with abnormal cervical cytologicalresults.Therefore,whenever‘HPVtesting’isreferredtoin the guidelines, it applies only to testing for high-risk(oncogenic) HPV types.There is increasing recognition that colposcopy is lesssensitive than previously thought and that a singlecolposcopic examination misses approximately onethird of women with CIN 2,3 [8
 Y 
10]. An analysis of the performance of colposcopy in ALTS indicates that
Table 1. Rating the Recommendations
Strength of recommendation
a
A Good evidence for efficacy and substantial clinicalbenefit support recommendation for use.B Moderate evidence for efficacy or only limitedclinical benefit supports recommendation for use.C Evidence for efficacy is insufficient to support arecommendation for or against use, butrecommendations may be made on other grounds.D Moderate evidence for lack of efficacy or for adverseoutcome supports a recommendation against use.E Good evidence for lack of efficacy or for adverseoutcome supports a recommendation against use.Quality of evidence
a
I Evidence from at least one randomized, controlled trial.II Evidence from at least one clinical trial withoutrandomization, from cohort or case-controlledanalytic studies (preferably from more than onecenter), or from multiple time-series studies,or dramatic results from uncontrolled experiments.III Evidence from opinions of respected authorities basedon clinical experience, descriptive studies, or reportsof expert committees.Terminology used for recommendations
b
Recommended Good data to support use when only one optionis available.Preferred Option is the best (or one of the best) when there aremultiple other optionsAcceptable One of multiple options when there is either dataindicating that another approach is superior or whenthere are no data to favor any single optionUnacceptable Good data against use
a
Modified from references [97, 98].
b
The assignment of these terms represents an opinion ratified by vote during theconsensus conference.
2006 Consensus Guidelines
 V 
Cytology
&
203

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