In November 2010, the International Federation of Gynecology and Obstetrics formally accepted a new classification system for causes of abnormal uterine bleeding in the reproductive years. The system, based on the acronym PALM-COEIN (polyps, adenomyosis, leiomyoma, malignancy and hyperplasia–coagulopathy, ovulatory disorders, endometrial causes, iatrogenic, not classified) was developed in response to concerns about the design and interpretation of basic science and clinical investigation that relates to the problem of abnormal uterine bleeding. A system of nomenclature for the description of normal uterine bleeding and the various symptoms that comprise abnormal bleeding has also been included. This article describes the rationale, the structured methods that involved stakeholders worldwide, and the suggested use of the International Federation of Gynecology and Obstetrics system for research, education, and clinical care. Investigators in the field are encouraged to use the system in the design of their abnormal uterine bleeding–related research because it is an approach that should improve our understanding and management of this often perplexing clinical condition.
In November 2010, the Fédération Internationale de Gynécologie et d’Obstétrique (International Federation of Gynecology and Obstetrics), more commonly known as FIGO, formally accepted a new classification system for causes of abnormal uterine bleeding (AUB) in the reproductive years that was e-published in February 2011 and print published in April of the same year. The system, based on the acronym PALM-COEIN (polyps, adenomyosis, leiomyoma, malignancy and hyperplasia–coagulopathy, ovulatory disorders, endometrial causes, iatrogenic, not classified), was developed in response to concerns about the design and interpretation of basic science and clinical investigation that relates to the problem of AUB.
So who needs this system? How was it developed? How should clinicians, educators, clinical investigators, and basic scientists use it when dealing with AUB in the reproductive years?
Background
When we try to evaluate studies that involve patients with AUB, a number of issues become readily apparent. First of all, there exists longstanding confusion concerning terminologies and definitions that are related to AUB. For example, what is “menorrhagia”? Is it a symptom? Is it a diagnosis? When 100 consecutive published research papers were reviewed for the use of the term, three-quarters of the papers considered it a symptom; the rest of the papers considered it a diagnosis. But even when it was used to describe a symptom, there was neither consistency regarding the menstrual pattern described nor consistency for the presence or absence of coexisting disease. The same issues are apparent for terms such as metrorrhagia, menometrorrhagia, and dysfunctional uterine bleeding. This confusion has led to inconsistency in the design and interpretation of clinical trials and to miscommunication among health care providers, trainees, and patients.
Related to the issue of terminologies and definitions is the fact that there are a number of clinical entities that may cause or contribute to AUB, >1 of which may be present in any given woman. Furthermore, the contribution of adenomyosis, coagulopathies, and many leiomyomas and endometrial polyps is often in question, because many of these entities may be asymptomatic in a given individual. Indeed, many clinical trials and even basic science studies are performed that do not even consider a number of potential diagnoses, which is a circumstance that brings into question the interpretation of the results and their appropriate application to clinical medicine.
As a consequence of this unsatisfactory situation, an international working group was created under the aegis and responsibility of FIGO that is now known as the FIGO Menstrual Disorders Working Group. This group has developed a strategy of activities around outstanding issues that relate to AUB; the first products have been a new and flexible system of terminology and an equally flexible system for classification of causes of AUB in the reproductive years.
The process of developing the systems
The process began with a rigorous peer evaluation of the terminology and definitions that are related to AUB in the reproductive years that served as a prelude to the design of a new, culturally sensitive and unambiguous system of terminology and classification of causes that could be translated easily into multiple languages. It was recognized that such an endeavor would not be possible without funding, and not successful without the participation of a wide spectrum of relevant stakeholders. Funding was obtained by means of unrestricted grants from pharmaceutical companies that were obtained and managed by a third-party health services organization, which allowed the organizers to function unencumbered by any corporate agenda or directives.
The process started in 2004 with the assembly of a multidisciplinary multinational set of gynecologists and hematologists, who were acknowledged experts in AUB, to participate in a face-to-face focused evaluation of the role and diagnosis of systemic disorders of hemostasis, commonly known as coagulopathies. The resulting articles were published simultaneously in Fertility and Sterility in 2005 and included a determination of the prevalence of disorders of hemostasis and their potential relationship with symptoms and, importantly, the appropriate screening techniques and laboratory procedures that would be required for diagnosis and consideration of options for management. This part of the process also helped to define context and the roles of primary care providers, gynecologists, and hematologists in the evaluation and treatment of women with these under-diagnosed systemic disorders.
The next steps were designed to rigorously evaluate definitions and to identify or develop new terminology that met the goals of simplicity, translatability, and acceptability to the wide spectrum of stakeholders. Another goal was to evaluate the need for a classification system and, if so confirmed, to implement a strategy that would be designed to culminate in a functional system that would be suitable for widespread use in research, teaching, and clinical care. Identified stakeholders included a worldwide spectrum of clinical investigators and other experts in the topic of AUB and representatives from the Food and Drug Administration, the World Health Organization, professional societies, and specialty journals that published AUB-related research. Investigators were selected on the basis of their contributions to the literature, and every attempt was made to include participants from a wide spectrum of countries and health care systems. Collectively, these individuals and organizations participated in a rigorous process using the Delphi software system (Rand Corporation, Santa Monica, CA) that comprised months of remotely administered questions and revisions that served to determine a “baseline” that included areas of existing agreement and inconsistency. Issues were resolved in 2005 during a 3-day meeting of all participants that was held in Washington, DC, with a structured process that was supported by an electronic voting system that preserved anonymity.
This introductory process resulted in a number of recommendations that included adoption of the term AUB as an overarching concept, recognition that the current terminology and definitions were generally unacceptable and irreparable, and the creation of a new set of terms for describing normal and AUB in the reproductive years. Poorly defined and confusing terminologies such as menorrhagia , metrorrhagia , and dysfunctional uterine bleeding were abandoned and replaced with a new recommended set of terms that were unambiguous and translatable into most other languages ( Table 1 ).
| Dysfunctional uterine bleeding |
| Epimenorrhagia |
| Epimenorrhea |
| Functional uterine bleeding |
| Hypermenorrhea |
| Hypomenorrhea |
| Menometrorrhagia |
| Menorrhagia (all usages: essential menorrhagia, idiopathic menorrhagia, primary menorrhagia, functional menorrhagia, ovulatory menorrhagia, anovulatory menorrhagia) |
| Metrorrhagia |
| Metropathica hemorrhagica |
| Oligomenorrhea |
| Polymenorrhagia |
| Polymenorrhea |
| Uterine hemorrhage |
Work on the classification system was initiated during the Washington meeting and further developed over the next 24 months. The goals included support of the design and interpretation of clinical and even some basic science research and provision of a context for teaching students and residents/ trainees and for counseling patients. The abandoned term dysfunctional uterine bleeding was replaced with an evidence-based set of 3 categories that defined causes of AUB in women that were unrelated to structural abnormalities of the uterus. These 3 groups of diagnoses (coagulopathies, ovulatory disturbances, and endometrial disorders) are sometimes referred to as “nonstructural” causes of AUB and will be described in detail later.
Another important aspect of the classification system was clinician and patient access to the methods that would be required to evaluate adequately a patient’s condition for cause regardless of country or health care system. It was determined that much of the categorization could take place with simple evaluations based on a structured history, readily available laboratory test results, and the use of ultrasound based techniques and/or hysteroscopy for evaluation of uterine structure. When the participants at the 2009 FIGO Congress were canvassed, it was apparent that the technical requirements for the system were available widely in all continents to a wide spectrum of clinicians. Consequently, the system is designed with the anticipation that clinicians have access to transvaginal ultrasound equipment and 1 or a combination of contrast sonography and hysteroscopy.
The next general meeting of the group was held in conjunction with the 2009 FIGO Congress in Cape Town, South Africa. After final adjustments to the classification system from an extended group of stakeholders, the organizers had the opportunity to present the system to a large group of >600 gynecologists from the international gynecologic community, many of whom were able to use electronic response systems to provide instantaneous and anonymous feedback. There were both general consensus from the Menstrual Disorders Working Group participants and overwhelming support from the multinational, multiethnic group that included both clinicians and members of the international academic community. The system was submitted to the FIGO Executive Board and was approved as a FIGO classification system in November 2010 ; the nomenclature system was accepted by FIGO in early 2011.
The process of developing the systems
The process began with a rigorous peer evaluation of the terminology and definitions that are related to AUB in the reproductive years that served as a prelude to the design of a new, culturally sensitive and unambiguous system of terminology and classification of causes that could be translated easily into multiple languages. It was recognized that such an endeavor would not be possible without funding, and not successful without the participation of a wide spectrum of relevant stakeholders. Funding was obtained by means of unrestricted grants from pharmaceutical companies that were obtained and managed by a third-party health services organization, which allowed the organizers to function unencumbered by any corporate agenda or directives.
The process started in 2004 with the assembly of a multidisciplinary multinational set of gynecologists and hematologists, who were acknowledged experts in AUB, to participate in a face-to-face focused evaluation of the role and diagnosis of systemic disorders of hemostasis, commonly known as coagulopathies. The resulting articles were published simultaneously in Fertility and Sterility in 2005 and included a determination of the prevalence of disorders of hemostasis and their potential relationship with symptoms and, importantly, the appropriate screening techniques and laboratory procedures that would be required for diagnosis and consideration of options for management. This part of the process also helped to define context and the roles of primary care providers, gynecologists, and hematologists in the evaluation and treatment of women with these under-diagnosed systemic disorders.
The next steps were designed to rigorously evaluate definitions and to identify or develop new terminology that met the goals of simplicity, translatability, and acceptability to the wide spectrum of stakeholders. Another goal was to evaluate the need for a classification system and, if so confirmed, to implement a strategy that would be designed to culminate in a functional system that would be suitable for widespread use in research, teaching, and clinical care. Identified stakeholders included a worldwide spectrum of clinical investigators and other experts in the topic of AUB and representatives from the Food and Drug Administration, the World Health Organization, professional societies, and specialty journals that published AUB-related research. Investigators were selected on the basis of their contributions to the literature, and every attempt was made to include participants from a wide spectrum of countries and health care systems. Collectively, these individuals and organizations participated in a rigorous process using the Delphi software system (Rand Corporation, Santa Monica, CA) that comprised months of remotely administered questions and revisions that served to determine a “baseline” that included areas of existing agreement and inconsistency. Issues were resolved in 2005 during a 3-day meeting of all participants that was held in Washington, DC, with a structured process that was supported by an electronic voting system that preserved anonymity.
This introductory process resulted in a number of recommendations that included adoption of the term AUB as an overarching concept, recognition that the current terminology and definitions were generally unacceptable and irreparable, and the creation of a new set of terms for describing normal and AUB in the reproductive years. Poorly defined and confusing terminologies such as menorrhagia , metrorrhagia , and dysfunctional uterine bleeding were abandoned and replaced with a new recommended set of terms that were unambiguous and translatable into most other languages ( Table 1 ).
| Dysfunctional uterine bleeding |
| Epimenorrhagia |
| Epimenorrhea |
| Functional uterine bleeding |
| Hypermenorrhea |
| Hypomenorrhea |
| Menometrorrhagia |
| Menorrhagia (all usages: essential menorrhagia, idiopathic menorrhagia, primary menorrhagia, functional menorrhagia, ovulatory menorrhagia, anovulatory menorrhagia) |
| Metrorrhagia |
| Metropathica hemorrhagica |
| Oligomenorrhea |
| Polymenorrhagia |
| Polymenorrhea |
| Uterine hemorrhage |
Work on the classification system was initiated during the Washington meeting and further developed over the next 24 months. The goals included support of the design and interpretation of clinical and even some basic science research and provision of a context for teaching students and residents/ trainees and for counseling patients. The abandoned term dysfunctional uterine bleeding was replaced with an evidence-based set of 3 categories that defined causes of AUB in women that were unrelated to structural abnormalities of the uterus. These 3 groups of diagnoses (coagulopathies, ovulatory disturbances, and endometrial disorders) are sometimes referred to as “nonstructural” causes of AUB and will be described in detail later.
Another important aspect of the classification system was clinician and patient access to the methods that would be required to evaluate adequately a patient’s condition for cause regardless of country or health care system. It was determined that much of the categorization could take place with simple evaluations based on a structured history, readily available laboratory test results, and the use of ultrasound based techniques and/or hysteroscopy for evaluation of uterine structure. When the participants at the 2009 FIGO Congress were canvassed, it was apparent that the technical requirements for the system were available widely in all continents to a wide spectrum of clinicians. Consequently, the system is designed with the anticipation that clinicians have access to transvaginal ultrasound equipment and 1 or a combination of contrast sonography and hysteroscopy.
The next general meeting of the group was held in conjunction with the 2009 FIGO Congress in Cape Town, South Africa. After final adjustments to the classification system from an extended group of stakeholders, the organizers had the opportunity to present the system to a large group of >600 gynecologists from the international gynecologic community, many of whom were able to use electronic response systems to provide instantaneous and anonymous feedback. There were both general consensus from the Menstrual Disorders Working Group participants and overwhelming support from the multinational, multiethnic group that included both clinicians and members of the international academic community. The system was submitted to the FIGO Executive Board and was approved as a FIGO classification system in November 2010 ; the nomenclature system was accepted by FIGO in early 2011.
FIGO terminology system
Acute vs chronic AUB
Acute AUB is now defined as “an episode of bleeding in a woman of reproductive age, who is not pregnant, that, in the opinion of the provider, is of sufficient quantity to require immediate intervention to prevent further blood loss.” Chronic AUB is “bleeding from the uterine corpus that is abnormal in duration, volume, and/or frequency and has been present for the majority of the last 6 months.”
The nomenclature system: defining normal
The design of the nomenclature system is based around clear and simple terms that should be understood by both women and men in the general community and that can be translated easily into other languages ( Table 2 ). Consequently, bleeding that can be defined as a “period” is described according to the following parameters: (1) regularity of onset, (2) frequency of onset, (3) duration of menstrual flow, and (4) heaviness (or volume) of menstrual flow.
