FIGO classification system (PALM-COEIN) for …

1 SPECIAL COMMUNICATIONFIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding innongravid women of reproductive ageMalcolm G. Munroa,b , , Hilary Critchleyc, Michael S. Broderd,Ian S. Frasere; for the figo Working Group on Menstrual DisordersaDepartment of Obstetrics and Gynecology, University of California, Los Angeles, USAbKaiser Permanente, Los Angeles Medical Center, Los Angeles, USAcCentre for Reproductive Biology, University of Edinburgh, Queen's Medical Research Institute, Edinburgh, UKdPartnership for Health Analytic Research, Beverly Hills, USAeUniversity of Sydney, Queen Elizabeth II Research Institute for Mothers and Infants, Sydney, Australiaabstractarticle infoArticle history:Received 27 November 2010 Accepted 7 January 2011 Keywords: abnormal uterine bleedingCausesClassificationInvestigatio nsTerminologiesThere is general inconsistency in the nomenclature used to describe abnormal uterine bleeding (AUB), inaddition to a plethora of potential causes several of which may coexist in a given individual.

2 It seems clearthat the development of consistent and universally accepted nomenclature is a step toward rectifying thisunsatisfactory circumstance. Another requirement is the development of a classification system , on severallevels, for the causes of AUB, which can be used by clinicians, investigators, and even patients to facilitatecommunication, clinical care, and research. This manuscript describes an ongoing process designed to achievethese goals, and presents for consideration the PALM-COEIN (polyp;adenomyosis;leiomyoma;malignancya nd hyperplasia;coagulopathy;ovulatory dysfunction;endometrial;iatrogenic; andnot yet classified) classification system for AUB, which has been approved by the International Federation of Gynecology andObstetrics ( figo ) Executive Board as a figo classification system . 2011 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and IntroductionThe investigation and management of abnormal uterine bleeding (AUB)amongnongravid women of reproductiveagehas been hamperedboth by confusing and inconsistently applied nomenclature and by thelack of standardized methods for investigation and categorization of thevarious potential etiologies[1,2].

3 Thesedeficiencies hamper theability ofinvestigators to study homogenous populations of patients experiencingAUB, and make it difficult to compare studies performed by differentinvestigators or research groups. The investigative leverage provided bymeta-analysis is undermined and, in some instances, made counterpro-ductive because inaccurate conclusions may result. Consequently, auniversally accepted system of nomenclature and classification seems anecessary step in the evolution of collaborative research and evidence-based application of results to clinical practice. The development of sucha system is made somewhat more complex by the fact that a variety ofpotential causes may coexist in a given individual and because manydefinable entities that often contribute to, or cause, AUB are frequentlyasymptomatic. As a result, to be clinically reliable, the design of any AUBclassification system must take this into with universal nomenclature and classification sys-tems in the gynecologic specialty is mixed.

4 For more than 85 years,cancer of the genital tract has been classified and staged accordingto what are now the International Federation of Gynecology andObstetrics ( figo ) oncology staging systems. The systems are practical,universally accepted, and aid clinicians and investigators in theguidance of research, treatment, and prognostication[3]. Wherenecessary, they are modified by a standing committee that followsevidence-based principles and meets regularly. By contrast, theAmerican Society for Reproductive Medicine (ASRM) staging systemfor endometriosis has been less successful[4]. This system , which useslaparoscopy-based visual assessment of disease extent, is hamperedby complexity, the need for surgical assessment, and the lack of anyconsistent relationship among visual staging of disease and symp-toms, appropriate treatment, and clinical outcome. Another systemthat has met with mixed review is the pelvic organ prolapsequantification system of pelvicfloor defects, which seems to haveclinical relevance but also a level of complexity that makes it difficultfor most clinicians to use in practice[5].

5 As a result of thesedeliberations, it would seem important to develop a nomenclatureand classification system thatfits research/educational requirementsand clinical needs, but is also present report, which includes contributions from an inter-national group of clinician investigators from 6 continents and over17 countries, proposes a new system for the classification of AUB. AInternational Journal of Gynecology and Obstetrics 113 (2011) 3 13 Corresponding author. Department of Obstetrics and Gynecology, Kaiser Perma-nente, Los Angeles Medical Center, 4900 Sunset Boulevard, Station 3-B, Los Angeles, CA90027, USA. Tel.: +1 323 783 4211; fax: +1 818 474 Munro).0020-7292/$ see front matter 2011 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and lists available atScienceDirectInternational Journal of Gynecology and Obstetricsjournal homepage: for symptom nomenclature has been described in previouspublications reporting the deliberations of this group[6,7].

6 2. MethodsThis multistage development process was part of the methodologydescribed formenstrual symptom nomenclature usinga modification ofthe RAND/UCLA Delphi process, which is a nominal group processdesigned to elicit opinion about a clearly defined topic[8,9] . A groupof panelists is presented with a series of items, which they rateanonymouslyand independently usinga numerical scale. The aggregateratings are then shared with the entire group and re-rated at an in-person meeting. After discussion, the panelists re-rate each item. Theprocess has been used extensively to develop clinical guidelines, andguidelines developed in this way have been found to be both reliableand associated with improvements in clinical outcome[10] .The goal of our panel was to develop an agreed pragmatic classi-fication system with a standardized nomenclature to be used world-wide by researchers and clinicians investigating and treating womenof reproductive age with AUB.

7 The panelists were selected to rep-resent the international community of gynecologists, reproductiveendocrinologists, and other clinicians and researchers with a partic-ular emphasis on including participants from low-income as wellas high-income countries. Gynecologists in full-time clinical practice,together with those with both a primary clinical and a research orien-tation, were began by developing a conceptual model of the elementsnecessary to diagnose AUB and then created a survey to elicitpanelists beliefs about classification . The survey also asked paneliststo rate a variety of assessment tools and techniques for evaluating thecause of AUB. The panel was asked to complete the survey before thefirst face-to-face meeting. Results were tabulated as the proportion ofrespondents giving a particular answer and as to whether there was agreement among respondents. Most items were rated on a 4-pointscale, and agreement was defined as at least 80% of respondents ratingthe item either 1 and 2, or 3 and 4.

8 For example, if the rating scale was1 = strongly disagree, 2 = disagree, 3 = agree, and 4 = stronglyagree, at least 80% of respondents had to give either a disagree answer (1 or 2) or an agree answer (3 or 4) for there to beagreement on that item. Results were reported as the mean of theresponses ( ).The panelists met in person in Washington, USA, for days fromFebruary 26 to 28, 2005, to discuss the survey results and work towardan internationally based agreement on the classification of diagnosesrelated to AUB. The aggregate survey responses were reviewed in aplenary session of all meeting participants, and again in small groupsdedicated to particular aspects of classification and extensive discussion, the small groups identified areas ofagreement and disagreement, which were used to create new surveyquestions. These modified surveys were then administered usingelectronic voting to all participants during a plenary session. In thissecond round of ratings, 2 levels of agreement were were considered to have agreed on an item if ratings met theoriginal criteria ( 80% of answers were either 1 and 2, or 3 and 4).

9 Panelists were considered to have unanimously agreed if all rated anitem either 1 and 2, or 3 and 4 ( 100% of respondents selectedeither 4 [strongly agree] or 3 [agree]). Following the in-personmeeting, the ScientificCommittee of the group merged and refinedthe components into a unified system , then distributed the draft to themembers of the entire group for comment and approval. Contentiousissues were further addressed via another short Delphi-type ques-tionnaire. A draft system was developed and revised, distributed forcomments, then discussed at a face-to-face meeting held inassociation with the 2009 figo World Congress in Cape Town,South Africa. Following minor modifications, the system waspresented to a group of over 700 figo attendees, 250 of whom hadanonymous keypad response systems with which to providefeedback. A preliminary version of the system was included in thebookAbnormal uterine bleeding [11].Throughout the process, the concept was the creation of a living document, together with a system of periodic analysis and appropri-ate Results of the rating processThe results of the nomenclature development process have beenpublished elsewhere[6,7].

10 The group agreed that AUB was notrestricted to just menstrual bleeding that was abnormally heavy, butalso included bleeding that was abnormal in timing (27/28 [ ]) a feature that was felt to be necessary for inclusion inthe classification was near unanimity among participants in agreeing that theterm dysfunctional uterine bleeding (DUB) should be discarded (29/31 [ ]). There was general agreement that abnormalities ofbleeding associated with pathology of the lower reproductive tractthat could be defined as " abnormal reproductive tract bleeding " butwhich were not within the domain of AUB would not be included inthe classification system (26/30 [ ]).In Cape Town, 215/237 ( ) respondents agreed that AUB wasa suitable overarching term for the symptom of disturbed menstrualbleeding, and 96/141 ( ) and 171/223 ( ), respectively, sup-ported proposals that the terms menorrhagia and DUB be dis-carded. Finally, 198/237 ( ) agreed that the term heavy menstrualbleeding (HMB) should replace the term menorrhagia for the symp-tom of excess menstrual of the group determined that the following general sourcesof bleeding should be considered inthe classificationsystem: (1) primarydisorders of the endometrium that most often manifest as disturbancesof local endometrial hemostasis, but which may also include otherentities such as altered vasculogenesis or abnormalities in the localinflammatory response; (2) endometrial polyps; (3) leiomyomas(fibroids); (4) adenomyosis; (5) disorders of ovulatory function;(6) systemic disorders of hemostasis that could be called coagulopathies;(7) malignant and premalignant conditions; (8) iatrogenic causes such asgonadal steroid administration.