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IUGA/ICS terminology and classification of complications of prosthesis and graft insertion–rereading will revalidate

Published:August 13, 2012DOI:https://doi.org/10.1016/j.ajog.2012.08.004
      To the Editors:
      As representative authors of the title document,
      • Haylen 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.
      we believe the authors of a recent multicategory critique
      • Tunitsky 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.
      might have most of their criticisms answered by a careful rereading of the document.
      • Haylen 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.
      Despite significant methodologic difficulties involving the interrater reliability validation study contained within the article,
      • Tunitsky 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.
      a positive data reinterpretation is also possible.
      The study observers
      • Tunitsky 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.
      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 3
      • Tunitsky 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.
      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.
      • Haylen 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.
      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.
      • Haylen 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.
      Category 2 criticism–Inability to categorize complications: category 1B
      • Haylen 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.
      clearly covers the scenario of pain without mesh exposure with the pain subclassification (a-e) available to distinguish the type of pain. The authors
      • Tunitsky 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.
      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 authors
      • Tunitsky 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.
      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
      • Haylen 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.
      and included in the critique) would note a clear increase in severity of complications across, and in general, down the table. The authors
      • Tunitsky 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.
      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 Classification
      • Haylen 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.
      clearly deals with multiple and changing complications.
      Authors of the IUGA/ICS Classification system for prostheses and grafts
      • Haylen 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.
      and the recently published native tissue female pelvic floor surgical equivalent
      • Haylen 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.
      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 document
      • Haylen 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.
      represent, we believe, multiple weaknesses in the current study
      • Tunitsky 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.
      and the accompanying critique.

      References

        • Haylen 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: 2-12
        • Tunitsky 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.e6
        • Haylen 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: 406-414

      Linked Article

      • Interrater reliability of the International Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications
        American Journal of Obstetrics & GynecologyVol. 206Issue 5
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          We 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.
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      • Reply
        American Journal of Obstetrics & GynecologyVol. 208Issue 1
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          We 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.
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