gynecology the two figo systems for normal and abnormal

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Int J Gynecol Obstet 2018; 143: 393–408 wileyonlinelibrary.com/journal/ijgo | 393 © 2018 Internaonal Federaon of Gynecology and Obstetrics Received: 18 May 2018 | Revised: 23 July 2018 | Accepted: 6 September 2018 | First published online: 10 October 2018 DOI: 10.1002/ijgo.12666 FIGO SPECIAL ARTICLE Gynecology The two FIGO systems for normal and abnormal uterine bleeding symptoms and classificaon of causes of abnormal uterine bleeding in the reproducve years: 2018 revisions Malcolm G. Munro 1,2, * | Hilary O.D. Critchley 3 | Ian S. Fraser 4 | for the FIGO Menstrual Disorders Commiee 1 Departments of Obstetrics and Gynecology, David Geffen School of Medicine at UCLA, University of California, Los Angeles, CA, USA 2 Kaiser Permanente, Los Angeles Medical Center, Los Angeles, CA, USA 3 MRC Centre for Reproducve Health, The University of Edinburgh, The Queen’s Medical Research Instute, Edinburgh, UK 4 School of Women’s and Children’s Health, Royal Hospital for Women, University of New South Wales, Randwick, NSW, Australia *Correspondence Malcolm G. Munro, Kaiser Permanente, Los Angeles Medical Center, Los Angeles, CA, USA. Email: [email protected] Parcipang Members of the FIGO Menstrual Disorders Commiee, 2015–2018 are listed at the end of the paper. Abstract Background: The Internaonal Federaon of Gynecology and Obstetrics (FIGO) sys- tems for nomenclature of symptoms of normal and abnormal uterine bleeding (AUB) in the reproducve years (FIGO AUB System 1) and for classificaon of causes of AUB (FIGO AUB System 2; PALM-COEIN) were first published together in 2011. The pur- pose was to harmonize the definions of normal and abnormal bleeding symptoms and to classify and subclassify underlying potenal causes of AUB in the reproducve years to facilitate research, educaon, and clinical care. The systems were designed to be flexible and to be periodically reviewed and modified as appropriate. Objectives: To review, clarify, and, where appropriate, revise the previously published systems. Methodology and outcome: To a large extent, the process has been an iterave one involving the FIGO Menstrual Disorders Commiee, as well as a number of invited contribuons from epidemiologists, gynecologists, and other experts in the field from around the world between 2012 and 2017. Face-to-face meengs have been held in Rome, Vancouver, and Singapore, and have been augmented by a number of telecon- ferences and other communicaons designed to evaluate various aspects of the sys- tems. Where substanal change was considered, anonymous vong, in some instances using a modified RAND Delphi technique, was ulized. KEYWORDS Abnormal uterine bleeding; Adenomyosis; Anovulatory bleeding; Arteriovenous malformaon; Coagulopathy; Endometrial hyperplasia; Endometrial polyp; FIGO; Heavy menstrual bleeding; Heavy uterine bleeding; Intermenstrual bleeding; Irregular menstrual bleeding; Irregular uterine bleeding; Isthmocele; Leiomyoma; Menorrhagia; Metrorrhagia; PALM-COEIN 1 | INTRODUCTION The worldwide impact of abnormal uterine bleeding (AUB) in the repro- ducve years is substanal, with a prevalence of approximately 3%–30% among reproducve aged women. The reasons for the wide spectrum of esmates are unclear but vary with age, being higher in adolescents and in the fiſth decade of life, and varying somewhat with country of origin. 1–9 Approximately one third of women are affected at some me in their life. 3,6 Many of the published studies are restricted to esmates of the prevalence of the symptoms of heavy menstrual bleeding (HMB); when other symptoms, parcularly those of irregular and intermenstrual bleeding are included, the prevalence rises to 35% or higher. 9 Available evidence suggests that as many as half of affected women do not seek medical care, even if they have access to a healthcare

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Page 1: Gynecology The two FIGO systems for normal and abnormal

Int J Gynecol Obstet 2018; 143: 393–408 wileyonlinelibrary.com/journal/ijgo  | 393© 2018 International Federation of Gynecology and Obstetrics

Received:18May2018  |  Revised:23July2018  |  Accepted:6September2018  |  Firstpublishedonline:10October2018DOI:10.1002/ijgo.12666

F I G O S P E C I A L A R T I C L EG y n e c o l o g y

The two FIGO systems for normal and abnormal uterine bleeding symptoms and classification of causes of abnormal uterine bleeding in the reproductive years: 2018 revisions

Malcolm G. Munro1,2,* | Hilary O.D. Critchley3 | Ian S. Fraser4 | for the FIGO Menstrual Disorders Committee

1DepartmentsofObstetricsandGynecology,DavidGeffenSchoolofMedicineatUCLA,UniversityofCalifornia,LosAngeles,CA,USA2KaiserPermanente,LosAngelesMedicalCenter,LosAngeles,CA,USA3MRCCentreforReproductiveHealth,TheUniversityofEdinburgh,TheQueen’sMedicalResearchInstitute,Edinburgh,UK4SchoolofWomen’sandChildren’sHealth,RoyalHospitalforWomen,UniversityofNewSouthWales,Randwick,NSW,Australia

*CorrespondenceMalcolmG.Munro,KaiserPermanente,LosAngelesMedicalCenter,LosAngeles,CA,USA.Email:[email protected]

ParticipatingMembersoftheFIGOMenstrualDisordersCommittee,2015–2018arelistedattheendofthepaper.

AbstractBackground:TheInternationalFederationofGynecologyandObstetrics(FIGO)sys-temsfornomenclatureofsymptomsofnormalandabnormaluterinebleeding(AUB)inthereproductiveyears(FIGOAUBSystem1)andforclassificationofcausesofAUB(FIGOAUBSystem2;PALM-COEIN)werefirstpublishedtogetherin2011.Thepur-posewas toharmonize thedefinitionsofnormalandabnormalbleedingsymptomsandtoclassifyandsubclassifyunderlyingpotentialcausesofAUBinthereproductiveyearstofacilitateresearch,education,andclinicalcare.Thesystemsweredesignedtobeflexibleandtobeperiodicallyreviewedandmodifiedasappropriate.Objectives: To review, clarify, and, where appropriate, revise the previouslypublishedsystems.Methodology and outcome:Toalargeextent,theprocesshasbeenaniterativeoneinvolvingtheFIGOMenstrualDisordersCommittee,aswellasanumberof invitedcontributionsfromepidemiologists,gynecologists,andotherexpertsinthefieldfromaroundtheworldbetween2012and2017.Face-to-facemeetingshavebeenheldinRome,Vancouver,andSingapore,andhavebeenaugmentedbyanumberoftelecon-ferencesandothercommunicationsdesignedtoevaluatevariousaspectsofthesys-tems.Wheresubstantialchangewasconsidered,anonymousvoting,insomeinstancesusingamodifiedRANDDelphitechnique,wasutilized.

K E Y W O R D S

Abnormaluterinebleeding;Adenomyosis;Anovulatorybleeding;Arteriovenousmalformation;Coagulopathy;Endometrialhyperplasia;Endometrialpolyp;FIGO;Heavymenstrualbleeding;Heavyuterinebleeding;Intermenstrualbleeding;Irregularmenstrualbleeding;Irregularuterinebleeding;Isthmocele;Leiomyoma;Menorrhagia;Metrorrhagia;PALM-COEIN

1  | INTRODUCTION

Theworldwideimpactofabnormaluterinebleeding(AUB)intherepro-ductiveyearsissubstantial,withaprevalenceofapproximately3%–30%amongreproductiveagedwomen.Thereasonsforthewidespectrumofestimatesareunclearbutvarywithage,beinghigherinadolescentsand inthefifthdecadeof life,andvaryingsomewhatwithcountryof

origin.1–9Approximatelyonethirdofwomenareaffectedatsometimeintheirlife.3,6Manyofthepublishedstudiesarerestrictedtoestimatesoftheprevalenceofthesymptomsofheavymenstrualbleeding(HMB);whenothersymptoms,particularlythoseofirregularandintermenstrualbleedingareincluded,theprevalencerisesto35%orhigher.9

Availableevidencesuggeststhatasmanyashalfofaffectedwomendo not seekmedical care, even if they have access to a healthcare

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provider,4,5,8acircumstancethatmayexplainthevariationinreportedprevalence.Themanifestationsvaryfrommodesttoseveredisruptionofworkproductivityandqualityof life,10,11and increasingmaternalmorbidityandmortalityforpregnantwomenwithpre-existingAUB-relatedanemia.12,13

In2011,recognizingtheinternationalneedcreatedbytheimpactof AUB, the International Federation of Gynecology and Obstetrics(FIGO),publishedapairofsystemsandasetofclinicalrecommenda-tionswiththeaimofinformingandaidingcliniciansandinvestigatorsinthedesignandinterpretationofinvestigationsintoAUBintherepro-ductiveyears,aswellastheprovisionofevidence-basedclinicalcare.14

ThepresentmanuscriptwasdesignedtoprovideadetailedupdateontheFIGOrecommendationsconcerning terminologies,definitions,andunderlyingcausesofAUBinthereproductiveyears.Revisedter-minologies and definitions of normalmenstrual parameters, and thesymptomsofAUBwereinitiallypublishedin2007,15,16whilethesem-inal 2011 publication14 presented both systems—Terminology andDefinitions(FIGO-AUBSystem1)andClassificationofCausesofAUBintheReproductiveYears,thePALM-COEINsystem(FIGO-AUBSystem2).Fromthebeginning,itwasdeterminedthattheserecommendationsshould beflexible and subject toongoing regular review to incorpo-rate resultsofnewresearchandanalysis.ThesereviewperiodswereintendedtobroadlycoincidewiththetriennialFIGOWorldCongresses.

Thefirstkeyrecommendations,publishedsimultaneouslyin2007in Fertility Sterility and Human Reproduction,15,16 recommended a substantial revisionofexisting terminologiesanddefinitions for thedescriptionofAUB featuresand,bydoing so, redefined thenormalparametersofmenstrualbleeding.Recommendedwastheabolitionofterms(largelyofLatinandGreekorigin)suchasmenorrhagia,metror-rhagia,anddysfunctionaluterinebleeding,whichwerepoorlydefined,used internationally in a disparate manner, and had no consistentmeaningforthegeneralandacademiccommunities.15–17

The second key publication14 presented a novel and pragmaticapproach to classification of the underlying causes ofAUB in non-pregnant women. No such systematic classification of underlyingcauses existed at that time. This 2011 manuscript introduced thePALM-COEIN classification based on clinical- and imaging-basedstratification of causes into “structural” pathologies that can be“imaged” and/or defined histopathologically (Polyps, Adenomyosis,Leiomyomas and Malignancy or atypical endometrial hyperplasia;PALM). The remaining causeswere categorized as “non-structural”,inthattheycannotbe imaged,butclinicalassessmentwithdetailedhistory and appropriatephysical examination, sometimes supportedbylaboratorytesting,canlargelyimplyormakeadiagnosisofcause(Coagulopathies,Ovulatorydisorders,primaryEndometrialdisorders,IatrogenicandNototherwiseclassified;COEIN).

Itrapidlybecameclearthateachoftheseindividualcausescouldrequiredivisionintosubclassificationsofcauseandphenotypetoopti-mizeclinicalmanagementandsupportthebroadspectrumofresearchneeded.Thesubclassificationofleiomyomaswasanobviousstartingpoint.14Threekeypublications14–17formedthefoundationofasim-ple,flexible,andeducationallysoundpairofdescriptivesystemsthatweredesignedtoprovideaquickinitialclinicaldirectionofdiagnosis

andmanagement,butalsotobeflexibleenoughtoprovideeffectivelinkageswithlaboratoryandresearchaspects.

ThepresentreportupdatestheFIGOrecommendationsforbothFIGO-AUBSystems1and2,includingclarificationsonterminologiesanddefinitions,aswellasmodificationsinthePALM-COEINsystemthatincludereassignmentofsomeentities,andguidanceforsubclas-sificationof leiomyomas,muchofwhichhasbeenpreliminarilypub-lished.18–20Thesechangesrepresentstructureddeliberativeprocessesthat includeuseofamodifiedRANDDelphiprocessapplied to theattendeesofaseriesofFIGOMenstrualDisordersCommittee(MDC)sponsored expert meetings. To allow this report to function inde-pendently,andtoprovidecontext,thereexistssubstantialbutneces-saryoverlapwiththeoriginalpublication,14andwithothersubsequentandrelatedpublicationsproducedbytheMDCsince2011.18–24

TheFIGOMDCiscurrentlyworkingonsubclassificationsystemsforadenomyosisandendometrialpolyps.Theadenomyosis subclassifica-tionsystemisthemostadvancedandwillbepublishedsooninprelimi-naryformwithplannedvalidationstudiestofollow.Thepolypsystemisbeingdevelopedbutareleasedatehasnotyetbeendetermined.ThereisconsiderationforsubclassificationsystemsforAUB-C,-O,-E,and–I,buttheseinitiativesarestillintheveryearlystagesofdevelopment.

ItisimportantthatcliniciansrecognizethattheseFIGOsystemsrelatesolelytoassessmentandmanagementofnongestationalAUB.Thereareothercausesofgenitaltractbleedingandurinarytractorgastrointestinalbleedingthatdonotcomefromtheuterus.Thesecanusuallybeidenti-fiedbyanappropriatecasehistoryandphysicalexamination.

2  | ACUTE VERSUS CHRONIC NONGESTATIONAL AUB IN THE REPRODUCTIVE YEARS

In the original system,14 FIGO introduced the concept of nonges-tationalacuteAUB in the reproductiveyears,distinguishing it fromchronic AUB—an approach endorsed by the American Collegeof Obstetricians and Gynecologists.25 These definitions remainunchangedfor2018.ChronicnongestationalAUBinthereproductiveyearsisdefinedasbleedingfromtheuterinecorpusthatisabnormalinduration,volume,frequency,and/orregularity,andhasbeenpre-sentforthemajorityofthepreceding6months.AcuteAUB,ontheother hand, is defined as an episodeof heavybleeding that, in theopinionoftheclinician,isofsufficientquantitytorequireimmediateinterventiontominimizeorpreventfurtherbloodloss.Acuteheavymenstrual bleeding may present in the context of existing chronicAUBorcanoccurintheabsenceofsuchabackgroundhistory.

3  | FIGO- AUB SYSTEM 1

3.1 | Revision of terminologies and definitions of symptoms of abnormal uterine bleeding

The revised FIGO-AUB System1 is seen in Figure1,with changessummarized inTable1.Asdeterminedby themultinationalprocess

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described in theoriginalpublications,14–16 termssuchasmenorrha-gia,metrorrhagia, oligomenorrhea, anddysfunctional uterine bleed-inghavebeenabandoned.Thereisacknowledgementofthespecificchanges in menstrual bleeding patterns that may be encounteredat each end of the reproductive spectrum (i.e. in adolescence ortheperi-menopause).26

Preparation of the present 2018 recommendations is the resultofsequentialreviewsoftheFIGO-AUBSystem1initiallyproposedin2007and2009,andunderwentslightmodificationfor2011.Thecur-rentrevisionsrepresentdeliberationsinmeetingsheldin2012,2015,and2017.Thesereviewshaveincludedcomment,detailedquestion-ing,andrecommendationsfrommanycliniciansfromaroundtheworldbuthaveonlyresultedinminorchangesandrefinementofdefinitionsfromtheoriginalsystem.

InthisrevisionofFIGOAUBSystem1,thedefinitionofregular-ityhasbeenchangedfromonewheretheshortestto longestvaria-tion isup to20days, tovariationof7–9days,dependinguponage

(18–25years≤9days;26–41years≤7days;42–45years≤9days).27 For practical purposes, this normal variation in cycle length can bealternativelyexpressedas±4days.

FormallyincludedisthetermHMB,asymptom(notadiagnosis),thathasbeendefined(inclinicalsituations)bytheNationalInstituteforHealthandClinicalExcellenceas“excessivemenstrualbloodloss,which interferes with a woman’s physical, social, emotional and/ormaterialqualityoflife”.5,28

4  | FIGO AUB SYSTEM 2

4.1 | Revision of classification of underlying causes of AUB (PALM- COEIN)

Highlights of changes since the original publication in 201114 are summarizedinTable2.Thebasic/coreclassificationsystemisalmostunchangedandispresentedinFigure2.Thereremaintheninemain

F IGURE  1 FIGOAUBSystem1.NomenclatureandDefinitionsofAUBSymptoms.For2018,intermenstrualbleedinghasbeenadded,andthereisnowapracticaldefinitionforirregularmenstrualbleedingcreatedbyusingthe75thpercentile,effectivelyexcludingtheoccasionallongorshortcyclesexperiencedbymanywomen.*Theavailableevidencesuggeststhat,usingthesecriteria,thenormalrange(shortesttolongest)varieswithage:18–25yofage,≤9d;26–41y,≤7d;andfor42–45y,≤9dHarlowetal.,2000.27Forclinicalpurposes,thedefinitionofHMBproposedbytheUKNationalInstituteforHealthandCareExcellencehasbeenadopted5,28–“Excessivemenstrualbloodlosswhichinterfereswithawoman’sphysical,social,emotional,and/ormaterialqualityoflife”.Abbreviations:AUB,abnormaluterinebleeding;FIGO,InternationalFederationofGynecologyandObstetrics;HMB,heavymenstrualbleeding.[Correctionaddedon12November2018,afterfirstonlineandprintpublication:Frequencyparameterhasbeenupdatedfrom‘Infrequent(<24days)’to‘Frequent(<24days)’and‘Irregular’modifiedto‘≥8-10days’.]

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categories, arranged according to the acronym PALM-COEIN (pro-nounced“palm-koin”):Polyp;Adenomyosis;Leiomyoma;Malignancyandhyperplasia;Coagulopathy;Ovulatory dysfunction; Endometrialdisorders; Iatrogenic; andNot otherwise classified. CategoryN hasundergoneachangefrom“notyetclassified”to“nototherwiseclassi-fied”aswecannotbecertainwhich,ifany,oftheseentitieswillulti-matelybeplacedinauniquecategory.ThecomponentsofthePALMgrouparegenerallydiscrete(structural)entitiesthatcanbeevaluatedormeasuredvisuallyusingsomecombinationofimagingtechniquesandhistopathology; theCOEIgroupcomprisesentitiesthatarenotdefinedby imagingorhistopathology(non-structural).By itsnature,the“Nototherwiseclassified”categoryincludesaspectrumofpoten-tialentitiesthatmayormaynotbemeasuredordefinedbyhistopa-thologyorimagingtechniques.

Thesystemhasbeenconstructedwiththeunderstandingthatagivenpatientmayhaveoneormoreentitiesthatcouldcauseorcon-tributetoAUBsymptomsandthatstructurallydefinableentities,suchasadenomyosis,leiomyomas,andendocervicalorendometrialpolypsareoftenasymptomaticand,therefore,maynotcontributetothepre-sentingsymptoms.

Since theoriginalpublicationof theFIGOAUBsystems,14 therehavebeenadvancesinthediagnosisofadenomyosis,althoughitsrela-tionship to reproductive functionanduterinebleeding is stillunderinvestigation. Ithasbeendemonstratedthattwo-dimensionaltrans-vaginalultrasonographyhassimilarsensitivityandspecificityforthediagnosis of adenomyosis when compared to magnetic resonanceimaging (MRI).29,30 There is some progress regarding the spectrumof two-dimensional ultrasonography findings associated with the

diagnosis,31,32 but no consensus regarding howmany andwhich ofthesefindingsarenecessarybeforethereisreasonablecertaintythatadiagnosisofadenomyosisispresent.Theeightcriteriasuggestedbythemorphologicaluterussonographicassessment(MUSA)groupareshowninFigure3.31TheFIGOMDCiscurrentlyworkingonaninter-national consensus for an imaging-based adenomyosis classificationsystemdesignedtophenotypethedisorderinastandardizedfashionthatshouldfacilitateresearch,education,andclinicalcare.However,fordiagnosistheuseofthetransvaginalultrasonography-basedMUSAcriteria31forthediagnosisofadenomyosisforthepurposesofFIGOAUBSystem2issuggested.

Theonlysubclassificationsystemratifiedsofaristheleiomyomasubclassificationsystem,essentiallyunchangedsincetheinitial2011publication14(Fig.4).TheonlysubtledifferenceisforType3myomas,wherecontactwiththeendometriumisafeaturesharedbyothersub-mucousleiomyomas(Types0,1,and2),whereasintramurallocation,withoutfocaldistortionoftheendometrialcavity, isacharacteristicofTypes4andhigher.Thesystemnowrecognizesthisareaofover-lap. It is also recognized that thereare somedifficulties in applyingtheleiomyomasubclassificationsystemtothespectrumof leiomyo-mas that canbeencountered,especially in largeuteriwithmultipleleiomyomas.33Thereisnowmoredetailedguidancefordistinguishingamongsttheleiomyomasubtypes.

DistinguishingbetweenType0and1,andbetweenType6and7leiomyomasisnowaccomplishedbycomparingthestalkdiameterto

TABLE  1 SummaryofchangestoFIGOSystem1(normalandabnormaluterinebleeding).

Parameter Change

Frequency Amenorrheaisnowpartofthefrequencycategory

Regularity Refineddefinitionofregularity

Normalvariation(shortesttolongest)7-9d

Slightvariancedependsonage

Duration Nowonlytwocategoriesforduration

Normal:≤8d

Prolonged:>8d

Volume DefinitionofthesymptomofHMB

NICEdefinition5,28

Bleedingvolumesufficienttointerferewiththewoman’squalityoflife

Intermenstrualbleeding

Definitionofthesymptomofinter-menstrualbleeding

Spontaneousbleedingoccurringbetweenmenstrualperiods

Canbeeithercyclical,orrandom

Abbreviations: FIGO, International Federation of Gynecology andObstetrics;HMB, heavymenstrual bleeding;NICE,National Institute ofCareExcellence.

TABLE  2 SummaryofchangestoFIGOAUBSystem2CausesorContributorstoAUBintheReproductiveYears(PALM-COEIN).

System 2 category Change

AUB-A Refinedsonographicdiagnosticcriteria

AUB-L InclusionofType3asasubmucousleiomyoma

Typedefinitionsanddistinctions

DistinctionbetweenTypes0and1;6and7

DistinctionbetweenTypes2and3;4and5

AUB-C NolongerincludesAUBassociatedwithpharmacologicagentsthatimpairbloodcoagulationwhicharenowincludedinAUB-I

AUB-I NowincludesAUBassociatedwithalliatrogenicprocessesincludingtheuseofpharmacologicalagentsusedforanticoagulationandthosethoughttointerferewithovulation

AUB-O DiagnosticthresholdchangesbasedupontherevisionsofSystem1,describedabove

Nolongerincludesovulatorydisordersassociatedwithdrugsknownorsuspectedtointerferewithovulation

AUB-N Thenameofthecategoryhasbeenchangedfrom“NotYetClassified”toNotOtherwiseClassified

ThereisabriefdiscussionofapotentialnewcauseofAUBtheso-calleduterine“niche”oristhmocelefollowinglowersegmentcesareansection

Abbreviations: AUB, abnormal uterine bleeding; FIGO, InternationalFederationofGynecologyandObstetrics.

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themeandiameteroftheleiomyoma.Types0and7nowcompriseleio-myomasthathaveastalkdiameterthatis10%orlessthanthemeandiameteroftheleiomyoma.HysteroscopyhasnowbeendeemedthestandardfordistinguishingbetweenaType2and3leiomyoma,withthedeterminationbaseduponthelowestfillingpressurethatallowsvisualizationoftheendometrialcavity.DistinguishingbetweenType4andType5leiomyomasshouldbebaseduponobservationofdistor-tionoftheserosa(Type5)asdeterminedbyultrasonographyorMRI.

FIGOnowprovidesadditionalguidanceforinvestigatorsusingtheFIGOsubclassificationsystemforleiomyomas.Aminimaldatasetfordescribingleiomyomasshouldincludeanestimateoftotaluterinevol-umebasedon imaging (transabdominalor transvaginalultrasonogra-phyorMRI),aswellasanestimateofthenumberofleiomyomas(1,2,3,4,orgreater than4). Ifsuch imaging isnotavailable,suchasmaybe thecase in low-resourcecountries, theminimumdata set shouldincludeanestimateofuterinesizeonclinicalexaminationasequivalent

F IGURE  2 FIGOAUBSystem2.PALM-COEINSystemforClassificationofCausesofAUBintheReproductiveYears.Thebasicsystemcomprisesfourcategoriesthataredefinedbyvisuallyobjectivestructuralcriteria(PALM:Polyp;Adenomyosis;Leiomyoma;andMalignancyandhyperplasia),fourthatareunrelatedtostructuralanomalies(COEI:Coagulopathy;Ovulatorydysfunction;Endometrialdisorders;Iatrogeniccauses),andonereservedforentitiescategorizedas“Nototherwiseclassified”.Theleiomyomacategory(L)issubdividedintopatientswithatleastonesubmucousmyoma(LSM)andthosewithmyomasthatdonotimpacttheendometrialcavity(Lo).Modifiedwithpermission.

67 Abbreviations:AUB,abnormaluterinebleeding;FIGO,InternationalFederationofGynecologyandObstetrics.

F IGURE  3 Adenomyosisdiagnosticcriteria.GraphicaldepictionsoftheeightTVUScriteriaproposedbytheMUSAgrouparepresented.Theseincludeasymmetricalmyometrialthickening(A);myometrialcysts(B);hyperechoicislands(C);fanshapedshadowing(D);echogenicsubendometriallinesandbuds(E);translesionalvascularity(F),wherepresent;irregularjunctionalzone(G);andaninterruptedjunctionalzone(H).Identificationandevaluationofthejunctionalzonemaybestbeaccomplishedwiththree-dimensionalultrasonography.Forthepresentatleast,thepresenceoftwoormoreofthesecriteriaarehighlyassociatedwithadiagnosisofadenomyosis.Reproducedwithpermission.31 Abbreviations:MUSA,MorphologicalUterusSonographicAssessment;TVUS,transvaginalultrasonography.

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toagraviduterusof“X”weeks.WhentransvaginalultrasonographyorMRIareavailable,thelocation(anterior,posterior,left,right,orcenter)andtheestimatedvolumeofuptofourindividualleiomyomasshouldberecorded.Additionally,thelocationintheverticalplaneshouldbedescribed;upperhalf, lowerhalf, orboth.Whenmore than four arepresent,thevolumeofthelargest leiomyomashouldberecorded,asaminimum.Ifotherleiomyomasarejudgedtobeofequalorgreaterrelevanceforclinicaldecisionmakingbasedonlocation,thevolumeoftheselesionsshouldberecordedaswell.Iftheendometriumisvisual-ized,thentherelationshipbetweenthedocumentedmyomasandtheendometriumshouldbedescribedusingtheFIGOclassificationsystem.

Women with AUB and associated malignant or premalignantlesions of the uterus (e.g. endometrial carcinoma, leiomyosarcoma,andatypicalendometrialhyperplasiasometimes,referredtoasendo-metrialintraepithelialneoplasiaorEIN34,35),arecategorizedashavingAUB-M.Theircategorization is furtherdefinedusingexistentWHOandFIGOclassificationandstagingsystems.36,37

AUB associatedwith the use of selected categories of systemicpharmacotherapyorintrauterinesystemsordevices,isclassifiedas“iat-rogenic”.38Inadditiontogonadalsteroidssuchasestrogens,progestins,andandrogens,andagentsthatdirectlyaffecttheirproductionorlocalfunction,thiscategorynowincludesnonsteroidalpharmaceuticalsthatcontributetoovulatorydisorders,suchasthosethataffectdopaminemetabolism, includingphenothiazinesandtricyclicantidepressants. Intheoriginalcategorization,womenwithAUBassociatedwiththeuseofanticoagulantswerecategorizedwithcoagulopathies(AUB-C);inthisrevision, they are considered iatrogenic and classified asAUB-I.Thisincludes themodern, non-vitamin-K antagonists such as rivaroxabanthatappearstohaveagreaterimpactonthevolumeofmenstrualbleed-ingthanthetraditional,vitaminKantagonists,typifiedbywarfarin.39,40

Category“N”,“nototherwiseclassified”wascreatedintheoriginalsystemtoaccommodateentitiesthatarerarelyencounteredorareilldefined.These include,but arenot limited to, entities suchas arte-riovenousmalformations (AVMs)41 and the lower segment or upper

F IGURE  4 FIGOleiomyomasubclassificationsystem.System2classificationsystemincludingtheFIGOleiomyomasubclassificationsystem.ThesystemthatincludesthetertiaryclassificationofleiomyomascategorizesthesubmucousgroupaccordingtotheoriginalWamstekeretal.system68andaddscategorizationsforintramural,subserosal,andtransmurallesions.Intracavitarylesionsareattachedtotheendometriumbyanarrowstalk(≤10%orthemeanofthreediametersoftheleiomyoma)andareclassifiedasType0,whereasTypes1and2requireaportionofthelesiontobeintramural—withType1beinglessthan50%ofthemeandiameterandType2atleast50%.Type3lesionsaretotallyintramuralbutalsoabouttheendometrium.Type3areformallydistinguishedfromType2withhysteroscopyusingthelowestpossibleintrauterinepressurenecessarytoallowvisualization.Type4lesionsareintramuralleiomyomasthatareentirelywithinthemyometrium,withnoextensiontotheendometrialsurfaceortotheserosa.Subserous(Types5,6,and7)leiomyomasrepresentthemirrorimageofthesubmucousleiomyomas—withType5beingatleast50%intramural,Type6beinglessthan50%intramural,andType7beingattachedtotheserosabyastalkthatisalso≤10%orthemeanofthreediametersoftheleiomyoma.Classificationoflesionsthataretransmuralarecategorizedbytheirrelationshiptoboththeendometrialandtheserosalsurfaces.Theendometrialrelationshipisnotedfirst,withtheserosalrelationshipsecond(e.g.Type2–5).Anadditionalcategory,Type8,isreservedforleiomyomasthatdonotrelatetothemyometriumatall,andwouldincludecervicallesions(demonstrated),thosethatexistintheroundorbroadligamentswithoutdirectattachmenttotheuterus,andotherso-called“parasitic”lesions.Modifiedwithpermission.67Abbreviation:FIGO,InternationalFederationofGynecologyandObstetrics.

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cervical niche or “isthmocele” frequently found in association withprevious cesarean delivery and sometimes attributed to as a causeofAUB.42,43

5  | NOTATION

Afterthepatienthasundergoneappropriateinvestigation,discussedbelow,shecouldbefoundtohaveoneormorepotentialcausesof,orcontributorsto,theAUBsymptoms.Consequently,thesystemhasbeendesignedtoenableappropriatemulti-categorynotation.Whileitisrecognizedthatthisincreasedlevelofcomplexitywillbeofmostvalue to specialists and researchers, it should have utility for anyhealthcareprovider.

This approach has been designed following the example of theWHO TNM staging of malignant tumors, with each componentaddressed for allwomen investigated forAUB symptoms using thetwoFIGOAUBSystems.Forexample,ifanindividualwassuspectedtohaveadisorderofovulation,atype2leiomyoma,andnootheranoma-lies,theywouldbecategorizedasfollowsinthecontextofacompleteevaluation:AUBP0A0L1(SM) M0 -C0O1E0 I0N0. Itwas recognizedthatinclinicalpracticetheuseofsuchfullnotationmightbeconsid-eredcumbersome,soanoptionforabbreviationhasbeendeveloped.

TheabbreviatedFIGOdescriptionofthepatientpreviouslydescribedwouldbeAUB-LSM;-O.

FIGOnowencouragescliniciansandinvestigatorstoconsidertheuseofamatrixfortheevaluationofpatientswithAUBintherepro-ductiveyears(Fig.5).Thisallowsfortheidentificationanddocumen-tationofthestatusoftheinvestigation.

6  | RECOMMENDATIONS FOR CLINICAL INVESTIGATION

AwomanpresentingwithAUBmayhaveoneoranumberof fac-torsthatmaycontributetothegenesisofthesymptoms.UsingFIGOAUBSystem1 to define the types ofAUB symptomspresent is aprerequisitetoevaluationfortheelementsinFIGOAUBSystem2.Anumberofpathologicalentities(e.g.subserousleiomyoma)maybepresentthatarepossiblyorevenunlikelytobeacontributortothesymptoms.Consequently,theinvestigationofwomenwithAUBdur-ingthereproductiveyearsmustbeundertakeninascomprehensivebutpracticablefashiongiventheclinicalsituationandtheavailableresources,withthefindingscarefullyinterpretedfortheirroleinthesymptoms.Forexample,availableevidencewouldsuggestthatasin-gle 1-cm polypwould not be the cause of the symptom ofHMB.

F IGURE  5 FIGOAUBSystem2diagnosticmatrix.Asimplifieddiagnosticmatrixisillustratedintheleftpane.Eachoftheprimaryclassificationsystemelementsarelisted.Ifapatienthasnotbeencompletelyevaluatedforapotentialcauseitislistedinthe“?”column,ifevaluationhasdemonstratednoevidenceoftheabnormalitythe“N”columnischecked,andifassessmentispositive,anXisplacedintheappropriatebox.Anexampleisshowninthepanelontheright.ThepatienthasthesymptomofHMB,andinterimassessment,includingcontrasthysterosonographydocumentedintheleftmatrixhasrevealedasubserosalleiomyomadesignatedasLo.However,thepatienthadapositivehistoricalscreeningresultforcoagulopathyandhematologicalassessmentsforcoagulationdisordersarenotyetavailable.Consequently,the“C”and“E”rowsremaininthe“?”category.Thehematologicalassessmentdemonstratesthatthereisnoevidenceofcoagulopathy,sothediagnosisofaprimarydisorderofendometrialhemostasisismade.TheCrowcannowbeassignedan“N”whiletheEcategorycanbecheckedas“Y”.Abbreviations:AUB,abnormaluterinebleeding;FIGO,InternationalFederationofGynecologyandObstetrics;HMB,heavymenstrualbleeding.

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AsuggestedapproachisillustratedinFigure6A,B,anddescribedinbriefbelow.

6.1 | General assessment

When evaluating awoman of reproductive agewith either acuteor chronic genital tract bleeding thought tobeAUB, the clinicianshould ensure that the bleeding is not related to pregnancy, andisemanating fromthecervicalcanal, rather thananother locationsuchasthevagina,vulva,perineum,orperianalregion.Pregnancymaybereliablyconfirmedwithaurineorserumassayforthepres-ence of the β-subunit of human chorionic gonadotropin (hCG). Itis to benoted that determinationof the locationor viability of apregnancyisnotconsideredtobewithinthedomainoftheFIGO-AUBsystems.WomenwithbothacuteandchronicAUBshouldbeevaluatedforirondeficiency,ifpossible,withserumferritin,andforrelatedanemiabymeasuringhemoglobinand/orhematocrit(pref-erablyafullbloodcount,includingplatelets).Oncethebleedinghasbeenconfirmed,orsuspected,tooriginate inthecervicalcanalorendometrialcavity,theclinicianshouldsystematicallyevaluatethepatient for each of the components of FIGOAUB System 2, thePALM-COEINclassification.

6.2 | Determination of ovulatory status

Predictable cyclic menses every 24–38days are usually (but notalways)associatedwithovulationwhereasbleedingassociatedwithovulatorydisordersistypicallyirregularintimingandflow,andofteninterspersedwithepisodesofamenorrhea.

If, largely based on FIGOAUB System 1, awoman is found tohaveAUBrelatedtoaovulatorydisorder,sheistobecategorizedasAUB-O. If there is uncertainty regarding ovulatory status,measure-mentofserumprogesterone,timedtothebestestimateofmid-lutealphase,may be useful for confirming ovulation in the current cycle.Whereas endometrial biopsy is not recommended as amethod fordeterminationofovulatorystatus,whenperformedandappropriatelyindicated—toevaluateforthepresenceofpremalignantormalignantendometrial change—histopathological findings reflecting secretorychangemayconfirmthatovulationhasoccurred.

6.3 | Screening for systemic disorders of hemostasis

A structuredhistory is a useful andeffective screening tool. FIGOsuggestsa tool thathasbeendemonstrated tohave90%sensitiv-ity for thedetectionof these relatively commondisorders (coagu-lopathies)44 (Table3). For those with a positive screening result,further testing is necessary, often following consultation with aphysicianwithaspecialinterestindisordersofcoagulation,suchasa hematologist. Such testsmay include assays for vonWillebrandfactor, Ristocetin cofactor, partial thromboplastin time (PTT) andothermeasures.45 If the resultsarepositive, thewomanwithAUBwouldbebeingcategorizedashavingAUB-C.Previously,byconven-tion, individualswithAUBassociatedwiththeuseofanticoagulant

therapywerecategorizedasAUB-C,buttheynowareincludedintheAUB-Icategory.

6.4 | Evaluation of the endometrium

Endometrial sampling isnot required for all patientswithAUB, soitisnecessarytoidentifythewomenforwhomendometrialbiopsyis appropriate. Selection for endometrial sampling is based ona combination of risk factors for the presence of premalignant ormalignantchanges,comprisingsomecombinationofage,personal,andgeneticriskfactors,andTVUSscreeningforendometrialecho-complexthickness.5,46–49Althoughsomestudieshaveindicatedthatageisnotimportantasanindependentvariable,47mostsuggestthatendometrial sampling be considered for all women over a certainage,usually45years.5Itisalsoevidentthatobesitycontributessig-nificantly to the risk of premalignant andmalignant change in theendometrium,afeaturethatincreasestheriskofendometrialneo-plasiaeveninyoungwomeninthethirdandfourthdecadesoflife.50 Womenwithafamilyhistoryofhereditarynonpolyposiscolorectalcancersyndrome,nowcalledLynchSyndrome,havealifetimeriskofendometrialcancerofupto60%,withthemeanageatdiagnosisof48–50years.51,52Regardlessof theclinicalguideline,whenAUB ispersistentandeitherunexplainedorinadequatelytreated,endome-trialsamplingisnecessary—ifpossible—inassociationwithhystero-scopicevaluationoftheuterinecavity.28Sonohysterographyislikelyareasonablesubstituteforhysterographytodiagnoseforpolypsandsubmucousleiomyomas.53–55Thereexistanumberoftechniquesforendometrial sampling,but it is important that anadequate samplebeobtainedbeforethepatientcanbeconsideredat lowriskforamalignantneoplasm.56

Itisapparentthatarelationshipexistsbetweenchlamydialinfec-tionoftheendometriumandAUB.Consequently,itmaybeprudenttoconsiderevaluatingforthepresenceoftheorganisminsymptomaticpatients.57Althoughcervicalassaysseemreasonable,therelationshipbetweencervicallyobtainedspecimensandthepresenceofabsenceofendometrialinfectionisunclear.58Ifchronicendometritisisidenti-fied,patientsshouldbecategorizedashavingAUB-E.

6.5 | Evaluation of the structure of the endometrial cavity

Evaluation for structural abnormalities affecting the endometrialcavity is performed to identify pathology—including endometrial orendocervicalpolypsandsubmucousleiomyomas—thatcouldcontrib-utetoAUB.Transvaginalultrasonography(TVUS)isanappropriateandimportantscreeningtooland,inmostinstances,shouldbeperformedearly inthecourseofthe investigation. Ideally,theultrasonographysystemmustbeofadequatequalitytoclearlydisplaybothmyometrialandendometrial features, and theexaminer shouldhave theabilityto operate the scanning device and interpret the images displayed.Regardless,TVUSisnot100%sensitiveevenin idealcircumstancesbecausepolypsandothersmalllesionsmayeludedetection,eveninthecontextofanormalstudy.59,60

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(A)

(B)

FIGURE 6 InvestigativealgorithmsforpatientswithchronicAUBduringthereproductiveyears.(A)Initialinvestigationcomprisesastructuredhistory,physicalexamination,andtheuseofappropriateancillaryinvestigations,inpartbaseduponthehistoryandphysicalassessment.Evidencesuggestinganovulatorydisorderpromptsassessmentforendocrinopathy,whereasapositivescreeningresultforcoagulopathy(Figure7)willindicatetheneedforappropriatehematologicalassessment.Acompletebloodcountshouldbeperformedonallwomenwiththesymptomofheavymenstrualbleeding.(B)Apragmaticguidetouterineassessment.Iftheinitialevaluation(Figure6A)suggestsalowriskforcoagulopathy,structuralormalignant/premalignantchange,patientsmaybepresumedtohaveAUB-Eor-Oandofferedappropriatetreatmentoptions.However,ifthereisanenhancedriskforendometrialhyperplasiaormalignancy(left),endometrialsamplingisrecommended.Ifanadequatespecimenisnotobtained,hysteroscopicexaminationandbiopsyisrecommended.Ifthereisanenhancedriskforastructuralabnormality,transvaginalultrasonographyisthenextstep(right).Ifevaluationoftheendometriumissuboptimalorthereisasuggestionofanabnormalityaffectingtheendometrialcavity,eitherhysteroscopyorcontrasthysterosonographyisindicated.MRImaybeoccasionallyindicatedifhysteroscopyorcontrasthysterosonographyarenotfeasible,suchasinthecaseofvirginalwomen.Abbreviations:AUB,abnormaluterinebleeding;MRI,magneticresonanceimaging;TVUS,transvaginalultrasonography.ImagesareusedcourtesyofMalcolmG.Munro.

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(A)

(B)

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(C)

(D)

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If good ultrasonic images fail to show findings suggestive ofendometrialpolypsorsubmucousleiomyomas,theclinicianmayini-tiallypresumethatthestructureoftheendometrialcavityisnormal.However, ifthereareimagingfeaturesthat indicatethepresenceofendometrialpolyp(s), if thereare leiomyomas thatmayencroachonthe endometrial cavity, or if the examination is suboptimal, imag-ing with more sensitive techniques is recommended. These gener-ally include hysteroscopy and/or transvaginal ultrasonography withintrauterinecontrast,eithergelorsaline,termedsonohysterography.Whichofthesetechniquesisusedwilldependontheresourcesavail-abletotheclinician.53–55Inmostinstances,sonohysterographywillbemorereadilyavailable,particularlywhentheonlyavailableresourcesforhysteroscopyresideinanoperatingroom.However,ifofficehys-teroscopyisavailable,theremaybeadditionalvalue,particularlywhenpolypsaresuspected,ashysteroscopicallydirectedpolypectomywillbefeasibleinthesamesetting.

In some parts of theworld, notably in theUK (managed by theBritishNationalHealthService), there is anemphasisonconductinginvestigation andmanagement of the symptom ofHMB at the firstconsultation(“Onestopmanagement”,includingkeyhistory,examina-tion, transvaginal ultrasonography, and hysteroscopy, if indicated, atthesamevisit).28This typeofmanagementhasbeenassistedbythesystematicapplicationofthetwoFIGOAUBSystems–clearlydefiningthesymptomsusingFIGOAUBSystem1,andthen,followinganappro-priatelystructuredevaluation,categorizationofthefindingsorassess-mentsusingFIGOAUBSystem2,thePALM-COEINclassification.

Whenvaginalaccessisdifficultorimpossible,acircumstanceoftenencountered with adolescents and virginal women, TVUS, contrastsonohysterography, andofficehysteroscopymaynot be feasible. Insuch instances, there is a role forMRI.Alternatively, hysteroscopicexamination with indicated biopsies, performed under appropriateanesthesiamaybethebestapproach.

With thePALM-COEINclassification, thepresenceofapolyporpolyps(AUB-P)isconfirmedonlywithdocumentationofoneormoreclearlydefinedpolyps,generallywitheitherhysteroscopyorsonohys-terography.Usually, a patientmay be categorizedwith one ormoresubmucous leiomyomas (AUB-LSM) with either sonohysterographyorhysteroscopy.Whenusingeither, theclinicianshouldtakecaretoinfuse the distendingmediumwith low pressure so that the natural

relationships of the leiomyomawith the endometrium and myome-triumaredistorted.Asdescribedabove,FIGOnowrecommendsthatthedistinctionbetweenType2and3leiomyomasbebaseduponhys-teroscopyperformedusingthelowestpressurenecessarytoevaluatetheserelationships.Theuseofsonohysterographyforthispurposeisconsideredtobeasuitableandmorepracticalsubstituteinavarietyofclinicalsituations.

6.6 | Myometrial assessment

Fortheprimaryleiomyomacategorization,themyometriumisassessedprimarilywithacombinationofTVUSandtransabdominalultrasonog-raphytoidentifyleiomyomas,withanysuchidentifiedlesionleadingtoan“L”assignment.Forthesecondarysubclassification,itisneces-sarytodeterminetherelationship(contactornot)oftheendometriumwiththeleiomyomabyperformingsomecombinationofTVUS,con-trastsonohysterography,hysteroscopy,andMRI.Shouldoneormoresubmucousleiomyomasbefound(Types0,1,2,or3)thenthewomanisstatedtohaveLSM,ifonlyType4,5,6,7,and/or8areidentified,thecategorizationisLo.

Tertiarysubclassificationofleiomyomatyperequiresthattheclini-cianclarifytherelationshipoftheleiomyomaswiththeendometrium,endometrialcavity,myometrium,anduterineserosa.Atleastforthoseleiomyomasthatdonotdistort theendometrialcavity (Types3andup),thisdistinctionrequirestheuseof imaging,eitherultrasonogra-phy,or,moreaccuratelyMRIasdescribedpreviously.

The myometrium should also be evaluated for the presence ofadenomyosisortodistinguishbetweenleiomyomasandlocalizedcol-lectionsofadenomyosisoradenomyomas.31,61ThesonographicandMRIcriteriaforthediagnosisofadenomyosisaredescribedelsewhereinthepresentdocument.WhiletheFIGOMDCiscurrentlydevelop-ingasystemfortheclassificationofadenomyosis,forthepresent,anassignment ofAUB-A is best based on imaging findings consistentwithTVUSasdescribedabove31 (Fig.3)or, ifavailable,usingMRI.30 Althoughpromisingforthediagnosisofadenomyosis,theroleofboththree-dimensionalTVUS62,63andsonographicelastography64,65isstillasubjectofinvestigation.

If available, MRI may be necessary for evaluation of the myo-metrium todistinguishbetween leiomyomasandadenomyosis.MRI

FIGURE  7 FourexamplesoftheuseofamatrixtoguideFIGO-basedevaluationofpatientswithchronicAUB.(A)Patientwiththesymptomofheavymenstrualbleeding(durationofmenses10dandperceivedandaffectingthepatient’squalityoflife).ContrastsonohysterographydemonstratesaposteriorType2leiomyoma1.85by1.49cmindiameter.Allotherinvestigationshavebeencompletedandarenegative.Diagnosis:AUB-LSM.(B)Herethecyclelengthvariesfrom14to60d,thedurationofmenstrualbleedingfrom2to11d,andthevolumerangingfromlighttoheavy.TransvaginalsonographyshowsaposteriorType6leiomyoma.Otherinvestigationsarenormalsavethethyroid-stimulatinghormone,whichiselevated.Diagnosis:AUB-Lo;-OwiththeprimarycauseofAUBtheovulatorydisordersecondarytohypothyroidism.(C)Inthisexamplethepatient’smenstrualparametersarenormalwiththeexceptionofhercomplaintofintermittentintermenstrualbleeding.ContrastsonohysterographyshowsanendometrialpolypandaType5leiomyoma(notshown).Thehysteroscopicviewatthetimeofthepolypectomyisshown.Diagnosis:AUB-P;-LowiththeprimarycauseoftheAUBtheendometrialpolyp.(D)Thispatienthasthecomplaintoflifelongheavymenstrualbleedingthatisbecomingheavier,withclots,andassociatedwithworseningdysmenorrheathatlaststheentireperiod.Shehasahistoryofeasybruisingandfrequentlybleedswhenbrushingherteeth.Hermensesarecyclicallypredictablewithanormalcyclelengthof33d.Transvaginalultrasonographyshowsaglobularuterus,anasymmetricallythickenedposteriormyometrium,andfan-shapedshadowing.Allofthecoagulationparametersmeasuredwereabnormal,andconsistentwithvWDType1.Diagnosis:AUB-A,-C.Abbreviations:AUB,abnormaluterinebleeding;FIGO,InternationalFederationofGynecologyandObstetrics;vWD,vonWillebranddisease.ImagesareusedcourtesyofMalcolmG.Munro.

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imagingmayalsobesuperiortoTVUS,sonohysterography,andhys-teroscopyformeasuringthemyometrialextentofsubmucousleiomy-omas.59However,relianceonMRIiscurrentlyimpractical,especiallyfor low-resourcenations,becauseoftherelativeorabsolute lackofaccesswithinmanyhealthcaresystems.66

7  | DISCUSSION

AUBinwomenofreproductiveageisamanifestationofanyofanumberofdisordersorpathologicentities.TheFIGOsystemsfornomenclatureandsymptoms(System1),andforclassificationofpotentialcausesofAUBinthereproductiveyears(System2)aredesignedtofacilitatebothbasicscienceandclinicalinvestigation,aswellasthepractical,rational,andconsistentapplicationofmedicalandsurgicaltherapyforaffectedwomen. The current revisions of the two FIGO-AUB systems aredesignedtoclarifyandmodify,inafashionthatshouldimprovetheutil-ityofthesesystemsforresearch,education,andclinicalcare.Clinicians,educators,andinvestigatorsareencouragedtousethematrixconcepttoguidetheevaluationofwomenafflictedwithchronicAUB,aswellasacuteAUBoncethepatientisstabilized(Fig.7).

Thesesystems,andtheircontinuedandappropriaterevision,repre-sentacollaborationinvolvingclinicians,investigators,andotherinformedparticipants from six continents. This participation was designed todevelopanimplementableSystem1andtoprovideinputintothepracti-calityofperformingtheinvestigationsdescribedforcategorizingaccord-ingtoSystem2,thePALM-COEINclassification.Currently,theroutinecharacterizationofstructurallesionsoftheuterususingMRIisnotfeasi-bleanditsuseisnotincludedasamandatorytoolforevaluatingpatientswithchronicAUB.Thisdoesnotmeanthatclinicianscannotorshould

notuseMRIif it isdeemednecessaryandisavailable,withtheresultsusedtocategorizeleiomyomatypeordeterminethepresence,absence,orlocationandextentofadenomyosis.

8  | CONCLUSION

ThepresentpaperreportsthechangestobothFIGOAUBsystemsbased on 6years of analysis, discussion, and debate since theoriginal publication. The original seminal publications presentedeffectiveapproachestotheterminologiesanddefinitionsaroundAUB(System1),followedbydevelopmentofanovelclassification(PALM-COEIN) of underlying causes of abnormal uterine bleed-ing in the reproductive years (System2).14 These developmentsandrefinementsare integrated intothewholeFIGO-AUBmodelinthismanuscript.

AUTHOR CONTRIBUTIONS

MGM,HODC,andISFcontributedtothedevelopment,drafting,andreviewofthepresentmanuscript.

PARTICIPATING MEMBERS OF THE FIGO MENSTRUAL DISORDERS COMMITTEE, 2015–2018

Rohana Haththotuwa, MD Chair; Alka Kriplani, MD, co-Chair; LuisBahamondes,MD,Ph.D;HilaryO.D.Critchley,MD;IanS.Fraser,MD;CarlosFüchtner,MD;MalcolmG.Munro,MD;RebeccaTonye,MD.

LIST OF CONTRIBUTORS TO THE PROCESS

TheparticipantsinthisprocesshavecontributedsubstantiallytotheevolvingdebatearoundseveralaspectsofthecommonsymptomsofAUBatworkshopsinWashington(2005),and/orCapeTown(2009),and/or Rome (2012), and/or Vancouver (2015), and/or Singapore(2017), and inprivatedebate.Theyhaveall approved the listingoftheirnames in thepresentmanuscript.Thenamesare listedalpha-beticallyandnoneof the individuals representedtheviewsof theirorganizations. The following have personally participated in thedevelopmentof theFIGOsystemsasparticipants inworkshops,onsubcommittees,insomeinstancesrepresentingtheirorganizationasindicatedintheparentheses.

David Archer, USA; Jason Abbott, Australia (AustralasianGynaecologic Endoscopy Society [AGES]); Ahmad Abdel-Wahed,Jordan; Luis Bahamondes, Brazil; Marina Berbic, Australia; VivianBrache, Dominican Republic; Daniel Breitkoph, USA (AmericanCollege of Obstetricians and Gynecologists [ACOG]); Andrew Brill,USA (AAGL); Michael Broder, USA; Ivo Brosens, Belgium; KristophChwalisz,USA;JustinClark,UK (RoyalCollegeofObstetriciansandGynaecologists [RCOG]); Hilary O.D. Critchley, UK; Catherine d’Ar-cangues, Switzerland (World Health Organization [WHO]); MargitDueholm, Denmark; Hans Mark Emanuel, Netherlands; CynthiaFarquhar, New Zealand (Cochrane Collaboration on Menstrual

TABLE  3 Screeninginstrumentforcoagulopathiesinwomenwiththesymptomofheavymenstrualbleeding.a,b

Initial screening for an underlying disorder of hemostasis in patients with excessive menstrual bleeding should be by a structured history. A positive screening result comprises any of the following:c

1.Heavymenstrualbleedingsincemenarche

2.Oneofthefollowing:

aPostpartumhemorrhage

bSurgicalrelatedbleeding

cBleedingassociatedwithdentalwork

3.Twoormoreofthefollowingsymptoms:

aBruising1–2timespermonth

bEpistaxis1–2timespermonth

cFrequentgumbleeding

dFamilyhistoryofbleedingsymptoms

aReproducedwithpermission.45bThis structuredhistory-based instrument is90%sensitive for thepres-enceofacoagulopathyinwomenwiththesymptomofheavymenstrualbleeding.cPatientswithapositivescreeningresultshouldbeconsideredforfurtherevaluation including consultationwith a hematologist and/or testing ofvonWillebrandfactorandRistocetincofactor.

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Disorders);MarioFestin,Switzerland(WHO);YokeFaiFong,Singapore(SocietyofEndometriosisandUterineDisorders[SEUD]);IanS.Fraser,Australia(RoyalAustralianandNewZealandCollegeofObstetriciansand Gynaecologists [RANZCOG]);Marc Fritz, USA; Carlos Fuchner,Bolivia (International Federation of Gynecology and Obstetrics[FIGO]); Sun-WeiGuo,China (SocietyofEndometriosis andUterineDisorders [SEUD]); Stephan Gordts, Belgium (European Society ofHuman Reproduction and Embryology [ESHRE]); GrigorisGrizimbis,Greece (European Society of Gynecologic Endoscopy [ESGE]);SiobanHarlow,USA;RohanaHathtootuwa,SriLanka(FIGO);OskariHeikinheimo,Finland;MarthaHickey,Australia;JenniferHigham,UK;WilliamHurd,USA(FertilitySterility);KeithIsaacson,USA(AmericanSociety of Reproductive Medicine [ASRM]); Julia Johnson, USA(ACOG); Alka Kriplani, India; Ricardo Lasmar, Brazil; Lee Learman,USA;CharlesLockwood,USA;AndreaLukes,USA;DianaMansur,UK;KristenMatteson,USA;MalcolmG.Munro,USA;ScottMonroe,USA(FoodandDrugAdministration[FDA]);IanMilsom,Sweden;AndrewMok,Canada(SocietyofObstetriciansandGynecologistsofCanada[SOGC]);EvanMyers,USA;AnitaNelson,USA;ShaughnO’Brien,UK(RCOG); David Olive, USA; Colin Pollard, USA (FDA); Rachel Pope,Israel; Oskari Heikinheimo, Finland; Elisabeth Persson, Sweden;Robert Rebar, USA (ASRM); Dorothy Shaw, Canada (FIGO); ShirishSheth, India (FIGO); Sukbir (Sony) Singh, Canada (SOGC); RobertSchenken,USA;JamesSpies,USA;ElizabethStewart,USA;DelphinTan,Philippines;DavidTaub,USA;RebeccaTonye,Cameroon;Zephnevan der Spuy, South Africa; Paolo Vercellini, Italy (ESHRE); KirstenVogelsong,Switzerland(WHO);PamelaWarner,UK.

CONFLICTS OF INTEREST

Each author has received royalties from Up-to-Date. MGM andISF have acted as consultants for, and/or given lectures for, andreceivedhonorariafromBayerAG(Berlin),BayerWomen’sHealth,andVifor Pharma,which has partly funded this initiative (as out-lined in the relevant publications). ISF has acted as a consultantforMerk.MGMhasfunctionedasaconsultanttoAbbvie,DatichiSankyo,MyovantSciences,andHologic,thelatteracontributortofunding to the FIGOMenstrualDisordersCommittee.HODChasacted as a consultant (no personal honoraria received) for BayerAG,PregLemSA,GedeonRichter,Vifor PharmaUK,AbbVie, andMyovantSciences.Manyotherorganizationsandcompanieshavecontributed in direct or indirectways to the development of thisprocess. The process has been approved by FIGO and the FIGOMenstrualDisordersCommittee.

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