Classification of Female Genital Tract Congenital Anomalies
Classification of Female Genital Tract Congenital Anomalies
The development of the new ESHRE/ESGE classification system by the CONUTA ESHRE/ESGE Working Group included the following steps (Fig. 1): (i) scientific work for the preparation of the questionnaires, the design of the new system and the preparation of an initial proposal for discussion among the experts in the field, (ii) consensus measurement through the use of the DELPHI procedure to assess the extent of agreement of the experts and to have their comments for the development of the new system and (iii) consensus development through the incorporation of the results of the DELPHI procedure and of the comments of the experts by the SC into the final classification system.
(Enlarge Image)
Figure 1.
Design and running of the project; the stepwise DELPHI consensus method has been used to find the agreement between the experts in the development of the new classification system.
Scientific work was necessary for the evidence-based development of the new classification system; it was also a prerequisite for the design of the structured questionnaires for the DELPHI procedure.
The scientific work had two distinct parts: (i) As first part, a systematic re-evaluation of the current proposals has been done and, based on their criticism, the characteristics of the new classification system have been clarified (Grimbizis and Campo, 2010). This work was run as a project of the EAGS and, it was later adopted by the SC of the CONUTA group. This document has been used as the scientific basis for the design of the structured questionnaire for the DELPHI procedure. (ii) The second part was the preparation of a proposal for the new updated clinical classification of female genital anomalies to be used during the DELPHI procedure to rank the agreement of the experts and to have their comments before deciding the final classification system. The proposal of the SC for the classification of uterine anomalies has only been published just before the second round of the DELPHI procedure (Grimbizis and Campo on Behalf of the CONUTA Group, 2012) in order to have the blind answers of the experts during round one.
DELPHI procedure is a well-known consensus method enabling to derive quantitative estimates through qualitative approaches. It aims to rank the agreement on a scientific issue with conflicting evidence, the extent to which each participant agrees with the issue under consideration and the extent to which the responders agree with each other (Fink et al., 1984; Jones and Hunter, 1995; Vonk Noordegraaf et al., 2011).
The DEPLHI procedure for the development of the new classification system has been designed and processed into two rounds as follows:
Preparation PhasePreparation of the structured questionnaires The SC, based on the scientific work previously described, has designed for the first round of the DELPHI procedure a structured questionnaire aiming to have the opinion of the participants on the need and the desired characteristics of a new classification system. For this reason, questions have been grouped under a limited number of headings and statements drafted for circulation to all participants ( Table I ). Furthermore, there was a section for comments. For the second round, the questionnaire has been changed aiming to assess the agreement of the participants with the new proposal and to have their comments on it ( Table II and Table III ).
It should be noted that in the same questionnaire there were parts aiming to assess the opinion of the participants for the existing classification systems (their advantages and their limitations) and to have their comments on them; the results on this issue will be presented in another document.
The agreement rate for each statement was calculated as follows: no. of participants who agree − no. of participants who disagree/no. of participants (agree+ indifferent+ disagree); agreement rates >67% are considered as consensus for agreement and <−67% as consensus for disagreement among the participants. Values between 50 and 67% are considered as indication of acceptance whereas between −50 and −67 as indication of rejection of the statement considered. Any value between 50 and −50% is considered as an expression of neutral opinion.
Selection of participants The selection of participants in the DELPHI procedure was a crucial issue. The SC decided to remain within the European borders since it was a European project; an invitation to participate together with a selection questionnaire was sent to all members of the ESHRE SIG RS (Special Interest Group Reproductive Surgery), all the ESGE members and to selected well-known European experts in the field. Acceptance of the invitation is thought to be an expressed interest in the field of female genital anomalies and responders were included in the list of the participants of the DELPHI procedure.
In total, the invitation has been sent to 454 professionals; 118 of them responded, thus becoming the participants of the DEPLHI procedure.
DELPHI Procedure: First Round DELPHI questionnaire has been sent to the 118 experts who accepted to participate in the procedure; participants were asked to rank their agreement with each statement in the questionnaire and to add their comments at the end.
In total, 89 (75.4%) participants responded to the questionnaire and made their comments. The main results of the first round were as follows ( Table I ):
Thus, the main conclusions from the first round of the DELPHI procedure were that there was a need for a new classification system, which had to be clear and accurate in its definitions, correlated with patients' management and as simple as possible. The smooth transition from the old system, mainly that of AFS, to the new one was not important in the design and the acceptance of the new system. Furthermore, anatomy should be used as the basic characteristic for patients grouping. The degree of consensus among the participants regarding these statements was thought to be extremely high. Moreover, there was an indication that uterus could be used as the key organ in the design of system's categories and embryology could be used as a secondary characteristic for patients' grouping.
DELPHI Procedure: Second Round The results of the first round have been taken into account in the new proposal for the classification system prepared in the meantime. After its publication (Grimbizis and Campo on Behalf of the CONUTA Group, 2012), the SC decided to start the second round of the DELPHI procedure.
Before sending DELPHI questionnaire Round 2, the SC has sent the following to the participants: (i) the results of the first round and (ii) the SC's proposal for the classification of female genital malformations (Fig. 1); DELPHI questionnaire Round 2 ( Table II and Table III ) has been sent 1 month later.
The participants have been asked to rank their agreement with each statement of the questionnaire and to add their comments at the end taking into account the results of the first round and the new proposed classification system.
In total, 71 (79.8%) participants responded. The main results of the second round were as follows ( Table II and Table III ):
Thus, the main conclusion of the second round was that it was observed an agreement consensus among the participants for the new proposed system. However, there were some points that could be incorporated creatively in the classification of female genital anomalies.
The final step in the creation of the new classification system was the development of consensus. For this reason, the results of the DELPHI procedure and the comments of the participants have been critically evaluated and the appropriate changes have been incorporated in the final version of the ESHRE/ESGE classification system. The main decisions of the SC in the process of consensus development were as follows:
In conclusion, the ESHRE/ESGE classification system was the final result of a process including scientific research, consensus assessment and consensus development.
Strategy for the Development of the New System
The development of the new ESHRE/ESGE classification system by the CONUTA ESHRE/ESGE Working Group included the following steps (Fig. 1): (i) scientific work for the preparation of the questionnaires, the design of the new system and the preparation of an initial proposal for discussion among the experts in the field, (ii) consensus measurement through the use of the DELPHI procedure to assess the extent of agreement of the experts and to have their comments for the development of the new system and (iii) consensus development through the incorporation of the results of the DELPHI procedure and of the comments of the experts by the SC into the final classification system.
(Enlarge Image)
Figure 1.
Design and running of the project; the stepwise DELPHI consensus method has been used to find the agreement between the experts in the development of the new classification system.
Scientific Work for the Design of the New System
Scientific work was necessary for the evidence-based development of the new classification system; it was also a prerequisite for the design of the structured questionnaires for the DELPHI procedure.
The scientific work had two distinct parts: (i) As first part, a systematic re-evaluation of the current proposals has been done and, based on their criticism, the characteristics of the new classification system have been clarified (Grimbizis and Campo, 2010). This work was run as a project of the EAGS and, it was later adopted by the SC of the CONUTA group. This document has been used as the scientific basis for the design of the structured questionnaire for the DELPHI procedure. (ii) The second part was the preparation of a proposal for the new updated clinical classification of female genital anomalies to be used during the DELPHI procedure to rank the agreement of the experts and to have their comments before deciding the final classification system. The proposal of the SC for the classification of uterine anomalies has only been published just before the second round of the DELPHI procedure (Grimbizis and Campo on Behalf of the CONUTA Group, 2012) in order to have the blind answers of the experts during round one.
DELPHI Procedure for Consensus Assessment
DELPHI procedure is a well-known consensus method enabling to derive quantitative estimates through qualitative approaches. It aims to rank the agreement on a scientific issue with conflicting evidence, the extent to which each participant agrees with the issue under consideration and the extent to which the responders agree with each other (Fink et al., 1984; Jones and Hunter, 1995; Vonk Noordegraaf et al., 2011).
The DEPLHI procedure for the development of the new classification system has been designed and processed into two rounds as follows:
Preparation PhasePreparation of the structured questionnaires The SC, based on the scientific work previously described, has designed for the first round of the DELPHI procedure a structured questionnaire aiming to have the opinion of the participants on the need and the desired characteristics of a new classification system. For this reason, questions have been grouped under a limited number of headings and statements drafted for circulation to all participants ( Table I ). Furthermore, there was a section for comments. For the second round, the questionnaire has been changed aiming to assess the agreement of the participants with the new proposal and to have their comments on it ( Table II and Table III ).
It should be noted that in the same questionnaire there were parts aiming to assess the opinion of the participants for the existing classification systems (their advantages and their limitations) and to have their comments on them; the results on this issue will be presented in another document.
The agreement rate for each statement was calculated as follows: no. of participants who agree − no. of participants who disagree/no. of participants (agree+ indifferent+ disagree); agreement rates >67% are considered as consensus for agreement and <−67% as consensus for disagreement among the participants. Values between 50 and 67% are considered as indication of acceptance whereas between −50 and −67 as indication of rejection of the statement considered. Any value between 50 and −50% is considered as an expression of neutral opinion.
Selection of participants The selection of participants in the DELPHI procedure was a crucial issue. The SC decided to remain within the European borders since it was a European project; an invitation to participate together with a selection questionnaire was sent to all members of the ESHRE SIG RS (Special Interest Group Reproductive Surgery), all the ESGE members and to selected well-known European experts in the field. Acceptance of the invitation is thought to be an expressed interest in the field of female genital anomalies and responders were included in the list of the participants of the DELPHI procedure.
In total, the invitation has been sent to 454 professionals; 118 of them responded, thus becoming the participants of the DEPLHI procedure.
DELPHI Procedure: First Round DELPHI questionnaire has been sent to the 118 experts who accepted to participate in the procedure; participants were asked to rank their agreement with each statement in the questionnaire and to add their comments at the end.
In total, 89 (75.4%) participants responded to the questionnaire and made their comments. The main results of the first round were as follows ( Table I ):
There was an agreement consensus among the participants that there was a need for a new classification system; agreement rate was as high as 82%. This confirms the initial feeling of the SC that the target to develop a new classification system corresponds to the needs of the scientific community.
Concerning the relative importance of the characteristics that a new system has to fulfill, the ranking was as follows (selected as one of the three more important characteristics): first to be clear and accurate with 72.1%, second to be correlated with patient's management with 66.2% and third to be simple and user friendly with 64.7%. The smooth transition from the old systems (mainly that of AFS) to the new one was the last in the ranking preferences of the participants.
Concerning the selection of the basic characteristics for patients' grouping in a new system, the results were as follows:
There was a high agreement consensus among the participants that 'anatomy should be used as the main characteristic' for the development of the new system with an agreement rate of 94.4%.
Participants did not support the use of embryology as the primary characteristic for patients' grouping with an agreement rate of 3.4%, but it seems that they could accept its use as a secondary characteristic with an agreement rate of 61.8%.
There was an indication of agreement among the participants that there is a key organ for patients' grouping with an agreement rate of 50.6% and most of them reported that this is uterus.
Thus, the main conclusions from the first round of the DELPHI procedure were that there was a need for a new classification system, which had to be clear and accurate in its definitions, correlated with patients' management and as simple as possible. The smooth transition from the old system, mainly that of AFS, to the new one was not important in the design and the acceptance of the new system. Furthermore, anatomy should be used as the basic characteristic for patients grouping. The degree of consensus among the participants regarding these statements was thought to be extremely high. Moreover, there was an indication that uterus could be used as the key organ in the design of system's categories and embryology could be used as a secondary characteristic for patients' grouping.
DELPHI Procedure: Second Round The results of the first round have been taken into account in the new proposal for the classification system prepared in the meantime. After its publication (Grimbizis and Campo on Behalf of the CONUTA Group, 2012), the SC decided to start the second round of the DELPHI procedure.
Before sending DELPHI questionnaire Round 2, the SC has sent the following to the participants: (i) the results of the first round and (ii) the SC's proposal for the classification of female genital malformations (Fig. 1); DELPHI questionnaire Round 2 ( Table II and Table III ) has been sent 1 month later.
The participants have been asked to rank their agreement with each statement of the questionnaire and to add their comments at the end taking into account the results of the first round and the new proposed classification system.
In total, 71 (79.8%) participants responded. The main results of the second round were as follows ( Table II and Table III ):
There was an agreement consensus among the participants that the new system fulfills their needs and expectations with an agreement rate as high as 84.5%,
More importantly, there was a high agreement consensus that the new proposed system seemed to be clear and accurate in its definitions with an agreement rate of 94.4%, comprehensive with an agreement rate of 91.6%, correlated with patients' clinical presentation with an agreement rate of 88.8% and correlated with patients' management with an agreement rate of 87.3%. Furthermore, there was also an agreement consensus that the new system seemed to be simple and user friendly with an agreement rate of 80.3%. Moreover, there was an agreement consensus that the new system gives the opportunity for a smooth transition from the old AFS system with an agreement rate of 70.4%, although this was not ranked as being important during the DELPHI first round.
The third part of the structured questionnaire included questions aiming to evaluate the agreement of participants on the design of the new system and the grouping of patients; the new system incorporates a lot of radical changes in the way of categorization.
There was an absolute agreement consensus that 'anatomy is used correctly as the basic characteristic in patients grouping' with 100% agreement rate, an extremely high agreement consensus that 'uterus is also correctly used as the key organ for the design of main classes' with an agreement rate of 93% and a high agreement consensus that 'uterine anomalies are classified successfully in the proposed V classes' with an agreement rate of 84.5%; the acceptance of these three points with such high rates is very important since they represent key concepts of the new system.
There was an agreement consensus that 'embryological origin is used successfully as a secondary characteristic for patients' grouping' with an agreement rate of 71.9%.
There was a high agreement consensus among the participants that 'the addition of normal uterus as Class 0 gives the opportunity to effectively classify cervical and/or vaginal anomalies and, thus, obstructive anomalies' with an agreement rate of 83.1%, an extremely high agreement consensus that 'the independent classification of cervical and vaginal anomalies gives the opportunity to clearly classify female genital anomalies' with an agreement rate of 94.4% and a high agreement consensus that 'cervical and vaginal anomalies are successfully classified in the proposed four classes' with an agreement rate of 83.1%; acceptance of these concepts is also very important since they represent a radical change in the classification design of the new system.
There was an indication of agreement (although not an agreement consensus) that 'the classification of fusion defects in one class (dysfused uterus/Class III) instead of two (didelphys and bicornuate uterus) in the AFS classification system is more functional and helps creating a more accurate and clear definition category' with an agreement rate of 64.7%. This point was another change in the design of the new system; taking into account the results of the DELPHI procedure and some comments of the responders, the members of the SC focused on the need to further clarify the terminology, the clinical concept and the definitions of this class and its sub-classes.
Furthermore, there were a lot of very useful comments from the participants, which were taken into account in the final version of the new system.
Thus, the main conclusion of the second round was that it was observed an agreement consensus among the participants for the new proposed system. However, there were some points that could be incorporated creatively in the classification of female genital anomalies.
Consensus Development
The final step in the creation of the new classification system was the development of consensus. For this reason, the results of the DELPHI procedure and the comments of the participants have been critically evaluated and the appropriate changes have been incorporated in the final version of the ESHRE/ESGE classification system. The main decisions of the SC in the process of consensus development were as follows:
The results of the DELPHI procedure indicated that the proposal of the SC fulfilled the expectations of scientists and was accepted by them; hence, it was decided to keep the main concepts in the design and the classes of the new system.
Together with the results of the DELPHI procedure for Class III (dysfused uterus), indicating the need for further clarification of its concepts and definitions, there was a comment pointing out that the term 'dysfused' is not commonly used. Examining this issue, the SC underlined that a descriptive term of the uterine gross morphology has been already adopted for most classes of the new system; on the contrary, the chosen term 'dysfused' is mainly an embryological one creating confusion. Thus, it was decided to change this term with one describing the morphology of the uterus and including in its meaning the former 'bicornuate' and 'didelphys' uterus; the term bicorporeal is adopted as it was deemed more appropriate. Furthermore, in order to keep the same principles in the classes terminology, the term 'unilaterally formed uterus' was changed to 'hemi-uterus'.
The 'dysfused septate' uterus resulting from a concomitant fusion and absorption defect was included as a clear subcategory (IIIc) of Class III as 'bicorporeal septate uterus'.
The absence of arcuate uterus from the new classification system has been commented by a lot of participants; some groups supported the notion that even very small deformities of the uterine cavity (arcuate uterus) could be associated with poor pregnancy outcome (Tomazevic et al., 2007; Gergolet et al., 2012). However, it was pointed out that until now the term arcuate was quite confusing including patients with different degrees of uterine deformity, even partial septa, since its definition is not clear at all. Hence, the necessity to have clear definitions was more than obvious based on the experience gained from the application of the AFS system. Thus, it was decided that septate uterus should remain a clear category including only patients with midline indentation of >50% of the uterine wall thickness. A new subcategory under the general term 'others' was added in Class I/dysmorphic uterus, giving the opportunity to include all minor deformities of endometrial cavity including midline indentations <50% of the uterine wall thickness; the clinical value of this variant needs further clinical research. Thus, definition of classes and especially those of septate uterus remained clear.
There were some comments regarding the subcategories of cervical and vaginal anomalies. A proposal to include partial vaginal agenesis as a different subcategory has not been adopted since it does not seem to be of any clinical value. The term (cervical/vaginal) dysplasia was deleted from the classification since it is generally used for intraepithelial neoplasia. Thus, the subcategories remained as in the initial proposal.
The simplicity of the new system has been discussed. It was pointed out that for the vast majority of anomalies only the use of uterine categories was necessary, while cervical and vaginal ones were not.
In conclusion, the ESHRE/ESGE classification system was the final result of a process including scientific research, consensus assessment and consensus development.
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