{"paper_id":"28ffa84f-5730-41c9-9bc4-26a4bef311d5","body_text":"Citation: Paroneto SC, Leonardi M, da Silva Costa F, Herren H, Condous G and Poli-Neto OB. A Delphi \nConsensus-Based Chronic Pelvic Pain Standardized Ultrasound Approach. Austin J Obstet Gynecol. 2022; 9(2): \n1206.\nAustin J Obstet Gynecol - Volume 9 Issue 2 - 2022\nSubmit your Manuscript | www.austinpublishinggroup.com \nParoneto et al. © All rights are reserved\nAustin Journal of Obstetrics and Gynecology\nOpen Access\nAbstract\nObjective: To develop a standardized, consensus-based international \nultrasound approach on the elements that should be included in the initial \nultrasound assessment of women with CPP that can be, in future, applied in \nclinical practice.\nMethods: A Delphi survey was conducted with an international panel of \nexperts in CPP and ultrasound, selected for their clinical and scientific experience \nin the subject. Three rounds of questions were carried out to assess the main \nparameters that should be included in the ultrasound reporting template. For \nvariables to be included in the template, a priori consensus criteria were used \nto reach agreement. \nResults: Of the 86 experts invited, 21 completed the final (third) round of the \nDelphi process. Experts represented North America, South America, Europe, \nand Australia. The final CPP ultrasound approach and reporting template \nestablished by the experts’ consensus contains 1) the assessment of the quality \nof the examination, 2) the necessary equipment, 3) the regions to be evaluated, \nand 4) elements that must be included in the exam.\nConclusion: Based on consensus methodology, we propose a standardized \ninternational ultrasound approach on the elements that should be included in the \ninitial ultrasound assessment of women with CPP. Whilst it requires validation, \nthis tool may serve to standardize the performance of the ultrasound for the \nindication of CPP, enhancing the evaluation of the broad differential diagnostic \nand the clinical applicability.\nKeywords: Chronic pelvic pain; Delphi survey; Standardized report; \nUltrasound\nResearch Article\nA Delphi Consensus-Based Chronic Pelvic Pain \nStandardized Ultrasound Approach\nParoneto SC1*, Leonardi M3,4, da Silva Costa F5, \nHerren H2, Condous G4 and Poli-Neto OB2\n1Department of Obstetrics and Gynecology, Julio Muller \nUniversity Hospital, University of Mato Grosso UFMT, \nBrazil\n2Department of Obstetrics and Gynecology, Ribeirão \nPreto Medical School of the University of São Paulo USP, \nBrazil\n3Department of Obstetrics and Gynecology, McMaster \nUniversity, Canada\n4Acute Gynaecology, Early Pregnancy and Advanced \nEndosurgery Unit, Sydney Medical School Nepean, \nUniversity of Sydney, Australia\n5Maternal Fetal Medicine Unit, Gold Coast University \nHospital and School of Medicine, Griffith University, \nAustralia\n*Corresponding author: Sharon Cristine Paroneto, \nDepartment of Obstetrics and Gynecology, Julio Muller \nUniversity Hospital. University of Mato Grosso – UFMT, \nLuis Philippe Pereira Leite Avenue. Alvorada. Cuiabá - \nMT, Brazil\nReceived: September 22, 2022; Accepted: October 19, \n2022; Published: October 26, 2022\nIntroduction\nChronic Pelvic Pain (CPP) is a common condition that can affect \nwomen. It is classically a problem during the reproductive age but \ncan last beyond menopause [1]. ReVITALize, an initiative led by the \nAmerican College of Obstetricians and Gynecologists (ACOG), aims \nto standardize terminology in gynecology and obstetrics, defines \nCPP as the presence of pain perceived as originating from pelvic \norgans/structures, typically lasting longer than 6 months [2]. CPP \nhas a negative impact on women’s quality of life [3], is associated \nwith mood disorders [4], high catastrophizing scores [5], childhood \nabuse and maltreatment [6], social isolation [7], negative interference \nin performing daily activities [8], and frequent use of health services \n[9]. The worldwide prevalence varies between 2% and 27%, being \nclose to 4% in developed countries [6,7]. Despite how common it is, \nno etiology is identified to explain this condition in approximately \none-third of the patients [10]. The complexity of dealing with the \ncondition includes lack of uniformity in definition, ignorance of \nits natural history, the large number of etiological factors [11,12], \ndifficulty in diagnostics [13], the need for multidisciplinary care [14], \nin addition to the disappointing results regarding long-term relief of \nthe symptoms [15].\nA recent systematic review showed modest evidence of the \ndiagnostic accuracy of ultrasound in patients with CPP [16], \ndespite the recommendations as a first-line test in the evaluation of \nthe female pelvices [18,19]. At least in part, this may be due to the \nabsence of consensual protocols for obtaining images and reports, \nwhich prevents a more precise conclusion about the usefulness or \nreal limitation of the method in this population. We believe that \nthis standardization is essential to allow adequate analysis of the \nmethod’s performance between centers and to limit the variability of \nacquisition and interobserver judgment. \nThis study aims to identify consensus on the elements that should \nbe included in the initial ultrasound assessment of women with CPP.\nThe consensus will require further validation to confirm its clinical \napplicability and efficacy.\nMethods\nDesign\nThe study was developed and confirmed in an electronic three-\nstage modified Delphi process. The questionnaires were sent via the \nSurvey Monkey (San Mateo, USA) platform to a panel of experts. \nThe initial questionnaire was formatted and judged by a local review \ncommittee of medical professionals and sonographers with at least 5 \nyears of experience in the field (Appendix 1).\n\nAustin J Obstet Gynecol 9(2): id1206 (2022)  - Page - 02\nParoneto SC Austin Publishing Group\nSubmit your Manuscript | www.austinpublishinggroup.com\nExpert Panel\nEligible experts were identified based on pre-specified criteria, \nincluding: publication record on PubMed in the field of chronic pelvic \npain and ultrasonography for the last 10 years (no minimum number \nof publications was necessary as quantity does not necessarily equate \nto expertise); being indicated as key opinion leader among national \nor international organization (e.g. ISUOG -International Society \nof Ultrasound in Obstetrics and Gynecology; SBE-Endometriosis \nBrazilian Society; WES-World Endometriosis Society) or considerable \nclinical experience on both fields according to their peers. All eligible \nexperts with a valid email address available were considered for \nparticipation. Participation was voluntary; a participant information \nsheet and consent form were presented to potential experts in round \none. The participants’ anonymity was preserved throughout the study.\nThere is no consensus in the literature on the number of \nspecialists needed, although a minimum between 10 and 20 seems \nto be acceptable [20]. Therefore, our goal at the end of the study was \nto reach the participation of at least 10 experts, without limiting the \nmaximum number.\nDelphi Study\nIn the absence of precise analytical techniques to achieve the \nobjective of the study, the expert consensus through a Delphi process \nwas considered an adequate methodology. It is a flexible, qualitative \ninvestigation that allows to gather opinions anonymously from several \nexperts, geographically separated, with unlimited interactions for \nopinions and judgments, enabling a consensus for complex problems \nand balances the opinion of as many experts as possible [21-23].\nA questionnaire was made in the English language, including \nLikert scale and open-ended questions (Appendix 1). The data \nobtained was divided into five categories: experts’ profile; assessment \nof the quality of the examination by operators; regions to be \nsystematically evaluated; elements that must be included in the exam; \nprobes and imaging modes. The questionnaire was sent via the Survey \nMonkey platform, by email, with a deadline of 4 weeks to respond. \nSome specific questions were elaborated including 3 consensuses \nalready established in pelvic ultrasound: IDEA (International Deep \nEndometriosis Analysis) [24], IOTA (International Ovarian Tumor \nAnalysis) [25], and MUSA (Morphological Uterus Sonographic \nAssessment) [26]. We used the anatomical terminology previously \nreported by these recommendations. Data was computed \nelectronically after each round and a new survey was elaborated for \nnew judgment of the disagreeing responses and for confirmation of \nthe ones that were agreed upon. The survey would not be displayed \nagain after completed by the expert. Despite the difficulty in selecting \nexperts in both chronic pelvic pain and ultrasonography, 86 experts \nwere invited to participate in round one.\nEvaluation of the Questions of the Structured \nQuestionnaire\nIn round one, a 7-point Likert scale anchored between one \n(completely disagree) and seven (completely agree) was used to \ndistinguish subtle differences in responses for the general first round. \nOn the second round (Appendix 2)  we chose a 5-point Lickert scale \nin order to improve the results because it yield data of higher quality \nfor the general first round [27] and thus strengthens the reliability of \nthe results obtained.\nThe criteria used for approval were [28]: 1) the items with more \nthan 70% consensus among the participants would be maintained; 2) \nthose between 50% and 70% would be restructured for retrial; 3) and \nthose below 50% would be suggested for exclusion. \nIn the third round, still controversial issues were asked again \nbased on binary choices (yes/no) - (Appendix 3) , and the item was \napproved when there was a minimum agreement of more than 50%.\nResults\nThe evaluated data will be presented into five categories as \ndescribed in the methods section. The summary of the experts’ \nconsensus is shown in (Table 1).\nExperts’ Profile\nEighty-six experts were invited. Of these, 29 (34%) completed \nthe first round within the allotted four weeks. The questionnaires \nwere then reformulated and sent back to the respondents. Twenty-\none of the 29 (72%) experts participated in the second and third \nrounds. More than 10 countries were represented in the final phase \nof the survey: Brazil (5), Canada (3), England (3), Italy (2), Belgium \n(1), Norway (1), Austria (1), Spain (1), Sweden (1), France (1), \nUnited States of America (1) and Australia (1). More than 90% of \nrespondents (n = 26/29) had at least 5 years of experience in clinical \ncare and/or ultrasound examination of women with CPP. As for \nspecific training in ultrasonography, 17 professionals took specialized \ncourses in gynecology and 4 of them took specialized courses in \nradiology (Figure 1).\nAssessment of the Quality of the Examination by \nOperators\nThe experts agreed at the end of the first round that the operator \nshould report the quality of the exam (93% agreement), the presence \nor absence of difficulties in its execution (90% agreement) and, if \nnecessary, report the reason for these difficulties during the exam \n(76% agreement). Agreements were confirmed in the second round.\nRegions to Be Systematically Evaluated\nIn the first round, the pelvic compartments (anterior, middle and \nposterior) and the abdominal quadrants (lower right and lower left) \nwere considered important by 82.1% and 75.0% of the specialists and \nconfirmed in the second round by 95.2% and 80.9%. Consensus on \nthe need to assess the abdominal wall and the inguinal region was \nonly obtained in the third round, and it was then approved by 57% \nof the experts.\nExperts did not consider the ultrasonographic evaluation of the \nupper abdomen, pelvic floor and pelvic vascular system essential, \nrecommending the exclusion of these regions from the initial \nstandardized report of these patients.\nElements That Must Be Included In the Exam\nThe application of the IDEA (International Deep Endometriosis \nAnalysis) and IOTA (International Ovarian Tumor Analysis) \nconsensuses were fully recommended by most respondents. The \napplication of the MUSA (Morphological Uterus Sonographic \nAssessment) consensus was partially recommended by the \nrespondents. In this case, the experts considered that the essential \ncriteria would be the evaluation o f the myometrium and the \n\nAustin J Obstet Gynecol 9(2): id1206 (2022)  - Page - 03\nParoneto SC Austin Publishing Group\nSubmit your Manuscript | www.austinpublishinggroup.com\njunctional zone.\nAs for the detailed assessment of the bladder, it was considered \nessential to report the following aspects: the presence of a focal lesion; \nthe size of the lesion; the degree of involvement of the lesion in the \nbladder wall; the distance from the lesion to the ureteral ostium and \nthe relation of the lesion to the vesical trigone.\nThe experts considered the evaluation of the appendix relevant \nand approved its inclusion in the standard report at the end of the \n3rd round with 57% agreement. On the other hand, they felt that the \nsystematic assessment of the ileum and cecum was not essential.\nThe assessment of the abdominal wall and the inguinal region was \napproved after the third round, with a recommendation for specific \nassessment of the umbilical (67%), infraumbilical (67%) and inguinal \n(92%) regions.\nProbes And Imaging Modes\nThe two-dimensional (2D) transvaginal probe was considered by \nmost specialists the ideal option for performing the examination of \nthe abdominal and pelvic regions in the first round (95.2% agreement) \nand confirmed in the second round (94.1% agreement). They also \nrecommended a 2D convex probe to complement the assessment of \nthe posterior pelvic compartment (76%), the intraperitoneal portion \nof the bladder (67%), the appendix, and the rectosigmoid (76%). The \n2D linear probe was chosen by 92% of the specialists in the 3rd round \nto assess the abdominal wall. Three-dimensional (3D) probe and \nDoppler velocimetry were not considered essential by the specialists.\nDiscussion\nIn this study, a standardized model containing important elements \nfor the ultrasound examination of women with CPP was defined. The \nproposal of an objective model can significantly help the clinician \nin decision making and most of these professionals prefer objective \nreports, tabulated and separated into items [29,30]. Having a clear \nand brief description of the quality and difficulties faced in carrying \nout the exam, the structures and/or areas analyzed, and the technical \nparameters used is highly desirable [31]. In addition, standardization \nis also important to reduce any variation in the quality of ultrasound \nperformance and interpretation by professionals with varied practical \nexperience [32]. Including the report of the quality of this screening \ntest guides the clinician regarding the reliability of the test and the \npropaedeutic sequence of CPP; pointing, or not; the need for future \ncomplementation.\nThe evaluation of the pelvic region by compartments (anterior, \nmiddle and posterior), as well as the lower right quadrant (with \nregard to the appendix), the lower left quadrant (with regard to the \nrectosigmoid) and the abdominal wall were endorsed by the study. The \ndefinition of the areas of greatest interest to be evaluated centralizes \nthe examiner’s focus, allowing for more objective information, \nwithout redundancy or absence of data to the assistant physician.\nApproval for the specific use of the criteria defined in the IDEA, \nFigure 1: Experts profile.\nExamquality\nGeneral quality\nPerceptionofdifficulties\nDescription of difficulties, if any\nRegions to be systematically evaluated\nPelvic compartments (anterior/middle/posterior)\nRight and left lower quadrants\nAbdominal wall and Inguinal ring\nElements that must be included in the exam\nIDEA consensus\nIOTA consensus\nMUSA consensus (only myometrium and junctional zone)\nBladder\nAppendix\nUmbilical region of the abdominal wall\nInfraumbilical region of the abdominal wall\nInguinal region of the abdominal wall\nProbesandimagingmodes\n2D transvaginal (mainprobe)\n2D linear (abdominal wall)\n2D convex (supplementary bladder, posterior compartment and appendix/\nrectosigmoid assessment)\nTable 1: A consensus-based model for the ultrasound assessment of women \nwith chronic pelvic pain.\n\nAustin J Obstet Gynecol 9(2): id1206 (2022)  - Page - 04\nParoneto SC Austin Publishing Group\nSubmit your Manuscript | www.austinpublishinggroup.com\nIOTA and MUSA consensus, albeit partially, reinforces the need to \nreaffirm the standardization and reproducibility of data. Although \nsuch consensuses are already well defined by scientific literature, their \napplication in clinical routine is still limited, either due to the lack of \ntrained professionals or effective protocols.\n The fact that the MUSA consensus was partially approved, keeping \nas essential only the assessment of the myometrium and junctional \nzone, reaffirms the search for pathologies most related to the painful \ncondition (leiomyomas and adenomyosis) [13]. Furthermore, its full \napplication requires more advanced technology, a longer learning \ncurve for operators and does not seem to add much to the search for \nother etiological diagnoses for CPP [33].\nEvaluation of the venous system was not recommended by most \nexperts. Despite the association reported in the literature, there are no \ncriteria that guarantee causality between pelvic congestion and CPP \n[34]. There is still a lack of uniformity in the criteria to be used for the \ndiagnosis of pelvic congestion. Several studies suggest parameters to \ndescribe pelvic vessels, including varicosities, the diameter and reverse \nflow of ovarian veins, the presence and diameter of myometrial veins \n[35,36]; but the absence of standardization to report pelvic congestion \nmay have been decisive for its exclusion from this screening test.\nRegarding the ultrasonographic evaluation of the pelvic floor \nof women with CPP, there are a few publications about it [37], but \nthe clinical applicability of this evaluation is still limited [38]. Even \nwith the opinion of specialists that only in cases of complaints and/or \nlocalized clinical findings such an assessment would be relevant, it can \nstill be questioned. There are doubts about the direct relationship of \nthe ultrasonographic finding with the clinical examination, and more \nstill with the relationship between these findings and CPP [39,40]. \nThere is no reliability of the inter and intra-observer assessment \nfor some points and the availability of 3D transvaginal ultrasound, \nmore suitable for this region, is not still comprehensive outside the \nreference services.\nThe inclusion of the appendix evaluation is perhaps based on the \nfact that ultrasonography is the first-line exam to exclude the diagnosis \nof appendicitis in young women in many institutions [41,42], \nalthough computed tomography is still described as the gold standard \nin the literature [43]. Imaging parameters for chronic appendicitis \nand appendicular endometriosis are similar to acute conditions, and \ndespite the low prevalence, they should not be neglected [43,44]. \nThe ultrasonographic diagnosis of these inflammatory processes has \nreached a high sensitivity, specificity and accuracy in some studies \n[45], mainly in the evaluation of young patients [46].\nAbdominal wall endometriomas, well described in the literature \nas a cause of CPP, are preferentially located close to surgical scars, \nmost commonly after cesarean sections [47,48]. The definition in \nthis study to assess only the umbilical, infra-umbilical and inguinal \nregions of the abdominal wall, despite its approval by a small \ndifference of experts, coincides with the most prevalent locations for \nthis condition [49].\nThe confirmation of the 2D transvaginal probe as the first \nchoice for the examination reaffirms its scope and effectiveness \nin the assessment of the pelvis, being complemented by linear and \nconvex 2D probes in the assessment of the abdominal wall and \ncomplementing the assessment of the posterior pelvic compartment, \nof the intraperitoneal portion of the bladder, of the appendix and the \nrecto sigmoid, respectively [19]. As for the 3D probe, so far there is \nnot a formal recommendation for its routine use in the evaluation of \nthe pelvis [50,51]. It’s a test with a higher cost, still inaccessible to the \npopulation at various levels of health services. However, the lack of \ncomparative and scientifically proven data and parameters between \nthis and other probes for the diagnosis of the main pelvic pathologies \nstill represents an obstacle for its use in screening exams [51].\nWhile our proposal comes from a respected group of experts, it \nhas some limitations. The low number of world experts with expertise \nin CPP and ultrasound, and the lack of consensus on the ideal number \nof specialists in this type of study may limit the representativeness \nof the proposal, despite it being considered satisfactory by some \nstudies [28,52]. Essentially functional conditions associated CPP, \nsuch as myofascial syndromes and others do not have morphological \nimaging parameters for their definition and are, therefore, a \n“hiatus” in this tracking exam.  Ultrasonography does not replace \nclinical history in identifying central nervous system involvement, \na fundamental constituent in the pathophysiological process of CPP \n[53]. Furthermore, it is also important to emphasize that some points, \ndecided in this consensus by a very small margin, certainly deserve \nfurther reflection, such as: does evaluating the abdominal wall and \nexcluding the pelvic venous system actually represent a scientific \nconsensus or does it require an extension of the study to other \nspecialists for a better conclusion?\nThese findings are still very preliminary and to truly represent a \nmodel of ultrasound reporting of women with CPP still need further \nconfirmation and improvement.\nConclusion\nWe believe the model proposed in this initial study defines \nminimum parameters for universality and comparability in data \npresentation, at the same time directing the operator’s steps and \nallowing the identification of the main “organic” causes of the pain \nsyndrome.\nReferences\n1. Ayorinde A, Bhattacharya S, Druce K, Jones G, Macfarlane G. 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