IUGA/ICS terminology and classification of complications of prosthesis and graft insertion–rereading will revalidate
2012; Elsevier BV; Volume: 208; Issue: 1 Linguagem: Inglês
10.1016/j.ajog.2012.08.004
ISSN1097-6868
AutoresBernard T. Haylen, Christopher Maher, Jan Deprest,
Tópico(s)Colorectal Cancer Surgical Treatments
ResumoAs representative authors of the title document,1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar we believe the authors of a recent multicategory critique2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar might have most of their criticisms answered by a careful rereading of the document.1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar Despite significant methodologic difficulties involving the interrater reliability validation study contained within the article,2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar a positive data reinterpretation is also possible.The study observers2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar have not been clearly identified. The retrospective observations are on variably notated medical records, whereas the IUGA/ICS Classification is designed for prospective “live” use with full clinical information. For example, the presence/size/timing or diagnosis and/or site of a mesh exposure, the category of most disagreement, may not have been clearly recorded, ideally with pictorial evidence.Reinterpretation of the data from Table 32Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar would suggest that 77% (40/52) of the instances of noncorrelation in the vaginal complication categories were due to record issues rather than the “clarity” of the assessment tool. If corrected and added to the 43% (39/91) where correlation occurred, a very acceptable 87% (79/91) interrater reliability is possible.As indicated, most of the answers to the multicategory criticisms, almost all unrelated to validation study, can be found within the title document.1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google ScholarCategory 1 criticism–Terminology and definitions: a terminology document will define terminology, eg, the reason for a 1 cm cutoff for (smaller/larger) mesh exposures is clearly explained.1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google ScholarCategory 2 criticism–Inability to categorize complications: category 1B1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar clearly covers the scenario of pain without mesh exposure with the pain subclassification (a-e) available to distinguish the type of pain. The authors2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar cite the IUGA/ICS Classification as “too complex in attempting to optimize the coverage of all possible (physical) complications” yet criticizes it for not additionally including functional (eg, bowel) disorders or recurrent urinary tract infection, the latter not necessarily related to the prosthesis or graft insertion.Category 3 criticism–Lack of consistency with scale: the authors2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar state “the IUGA/ICS classification system does not allow gradation of the severity and this may be a barrier to its utility.” Even the most cursory appraisal of the IUGA/ICS CTS Classification Table (Table 2 in 1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar and included in the critique) would note a clear increase in severity of complications across, and in general, down the table. The authors2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar pose the self-evident question, allegedly not answered by the IUGA/ICS Classification, “should the presence of multiple complications increase the degree of severity.” The IUGA/ICS Classification1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar clearly deals with multiple and changing complications.Authors of the IUGA/ICS Classification system for prostheses and grafts1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar and the recently published native tissue female pelvic floor surgical equivalent3Haylen B.T. Freeman R.M. Lee J. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related to native tissue female pelvic floor surgery.Int Urogynecol J. 2011; : 515-526Neurourol Urodyn. 2011; 31: 406-414Google Scholar encourage studies using the system including constructive criticisms related specifically to the results of well-performed prospective validation studies. Retrospectively, unclear data and a misreading of the title document1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar represent, we believe, multiple weaknesses in the current study2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar and the accompanying critique. As representative authors of the title document,1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar we believe the authors of a recent multicategory critique2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar might have most of their criticisms answered by a careful rereading of the document.1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar Despite significant methodologic difficulties involving the interrater reliability validation study contained within the article,2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar a positive data reinterpretation is also possible. The study observers2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar have not been clearly identified. The retrospective observations are on variably notated medical records, whereas the IUGA/ICS Classification is designed for prospective “live” use with full clinical information. For example, the presence/size/timing or diagnosis and/or site of a mesh exposure, the category of most disagreement, may not have been clearly recorded, ideally with pictorial evidence. Reinterpretation of the data from Table 32Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar would suggest that 77% (40/52) of the instances of noncorrelation in the vaginal complication categories were due to record issues rather than the “clarity” of the assessment tool. If corrected and added to the 43% (39/91) where correlation occurred, a very acceptable 87% (79/91) interrater reliability is possible. As indicated, most of the answers to the multicategory criticisms, almost all unrelated to validation study, can be found within the title document.1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar Category 1 criticism–Terminology and definitions: a terminology document will define terminology, eg, the reason for a 1 cm cutoff for (smaller/larger) mesh exposures is clearly explained.1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar Category 2 criticism–Inability to categorize complications: category 1B1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar clearly covers the scenario of pain without mesh exposure with the pain subclassification (a-e) available to distinguish the type of pain. The authors2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar cite the IUGA/ICS Classification as “too complex in attempting to optimize the coverage of all possible (physical) complications” yet criticizes it for not additionally including functional (eg, bowel) disorders or recurrent urinary tract infection, the latter not necessarily related to the prosthesis or graft insertion. Category 3 criticism–Lack of consistency with scale: the authors2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar state “the IUGA/ICS classification system does not allow gradation of the severity and this may be a barrier to its utility.” Even the most cursory appraisal of the IUGA/ICS CTS Classification Table (Table 2 in 1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar and included in the critique) would note a clear increase in severity of complications across, and in general, down the table. The authors2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar pose the self-evident question, allegedly not answered by the IUGA/ICS Classification, “should the presence of multiple complications increase the degree of severity.” The IUGA/ICS Classification1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar clearly deals with multiple and changing complications. Authors of the IUGA/ICS Classification system for prostheses and grafts1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar and the recently published native tissue female pelvic floor surgical equivalent3Haylen B.T. Freeman R.M. Lee J. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related to native tissue female pelvic floor surgery.Int Urogynecol J. 2011; : 515-526Neurourol Urodyn. 2011; 31: 406-414Google Scholar encourage studies using the system including constructive criticisms related specifically to the results of well-performed prospective validation studies. Retrospectively, unclear data and a misreading of the title document1Haylen B.T. Freeman R.M. Swift S.E. et al.An International Urogynecological Association (IUGA)/International Continence Society (ICS) Joint Terminology and Classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.Int Urogynecol J. 2011; 22: 3-15Neurourol Urodyn. 2011; 30: 2-12Crossref PubMed Scopus (228) Google Scholar represent, we believe, multiple weaknesses in the current study2Tunitsky E. Abbott S. Barber M.D. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications.Am J Obstet Gynecol. 2012; 206: 442.e1-442.e6Abstract Full Text Full Text PDF Scopus (22) Google Scholar and the accompanying critique. Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complicationsAmerican Journal of Obstetrics & GynecologyVol. 206Issue 5PreviewWe sought to assess interrater reliability of the International Continence Society (ICS)/International Urogynecological Association (IUGA) classification system of vaginal mesh-related complications and compare this with several other available complication classification systems. Full-Text PDF ReplyAmerican Journal of Obstetrics & GynecologyVol. 208Issue 1PreviewWe greatly appreciate the interest Dr Haylen and colleagues have shown in our recent article evaluating the interrater reliability of the International Continence Society/International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications. We are surprised by Haylen et al's assertion that the classification system is not appropriate for retrospective use and was “designed for prospective ‘live’ use with full clinical information” because it's clearly stated in the Preface of their most recent article they list “medical records and surgical audits” as among the possible applications of the system. Full-Text PDF
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