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The Pelvic Floor Complication Scale: a new instrument for reconstructive pelvic surgery

Published:November 05, 2012DOI:https://doi.org/10.1016/j.ajog.2012.10.889

      Objective

      The purpose of this study was to develop and test a unique, new pelvic floor surgery complication scale and compare it with an existing validated measure.

      Study Design

      Surgeons from 2 clinical trials networks rated complications based on perceived patient bother, severity, and duration of disability to develop a Pelvic Floor Complication Scale (PFCS). PFCS scores were calculated for subjects in 2 multicenter pelvic floor surgical trials. The PFCS and modified Clavien-Dindo scores were evaluated for associations with length of hospitalization, satisfaction, and quality-of-life measures (Health Utilities Index, Short Form-36, Urogenital Distress Inventory, and Incontinence Impact Questionnaire).

      Results

      We calculated PFCS scores for 977 subjects. Higher PFCS and Clavien-Dindo scores similarly were associated with longer length of hospitalization (P < .01), lower satisfaction (P < .01), lower Health Utilities Index scores (P = .02), lower Short Form-36 scores (P = .02), higher Urogenital Distress Inventory scores (P < .01), and Incontinence Impact Questionnaire scores (P < .01) at 3 months. No associations were present at 1 year.

      Conclusion

      The PFCS compares favorably to the validated modified Clavien-Dindo instrument.

      Key words

      Pelvic floor disorders, like pelvic organ prolapse and urinary incontinence, often impair a woman's quality of life (QoL) but rarely, in themselves, result in significant morbidity or death. The surgical procedures that are used to correct these conditions impart some risk of morbidity.
      • Brubaker L.
      • Glazener C.
      • Jacquetin B.
      • et al.
      Surgery for pelvic organ prolapse.
      Given this, patients and physicians must weigh carefully the benefits and risks of various treatment options when considering surgery. Successful surgical outcomes should take into account perioperative and postoperative morbidity. For example, a surgery that has excellent anatomic and symptomatic improvement, but increased morbidity, may not be as desirable as a surgery that has good anatomic and symptomatic improvement with minimal morbidity. Unfortunately, our ability to compare the outcomes of different procedures or surgical approaches is hampered by a lack of uniform reporting of perioperative morbidity. Perioperative complications are generally reported in surgical studies; however, complications are often reported only as a summation or are divided into major and minor categories at the discretion of the author.
      In recent years, clinical investigators published several surgical complication grading systems that allow more uniform classification and reporting of perioperative complications.
      • Dindo D.
      • Demartines N.
      • Clavien P.A.
      Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.
      • Clavien P.A.
      • Barkun J.
      • de Oliveria M.L.
      • et al.
      The Clavien-Dindo classification of surgical complications: five-year experience.
      • Strasberg S.M.
      • Linehan D.C.
      • Hawkins W.G.
      The Accordion Severity Grading System.
      These systems broadly classify complications into 1 of several groups and are intended for use in all surgical disciplines. The Clavien-Dindo system classifies complications into 1 of 4 categories that are based on the type of therapy that is needed to correct the complication.
      • Dindo D.
      • Demartines N.
      • Clavien P.A.
      Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.
      This system is reproducible, easy to apply, has been validated compared with complexity of surgery and length of hospital stay in general surgery populations, and has been used recently in several studies that have evaluated pelvic reconstructive procedures.
      • Diwadkar G.B.
      • Barber M.D.
      • Feiner B.
      • Maher C.
      • Jelovsek J.E.
      Complication and reoperation rates after apical vaginal prolapse surgical repair: a systematic review.
      • Brubaker L.
      • Cundiff G.W.
      • Fine P.
      • et al.
      Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence.
      • Albo M.E.
      • Richter H.E.
      • Brubaker L.
      • et al.
      Burch colposuspension versus fascial sling to reduce urinary stress incontinence.
      • Richter H.E.
      • Albo M.E.
      • Zyczynski H.M.
      • et al.
      Retropubic versus transobturator midurethral slings for stress incontinence.
      However, current systems are not condition specific and do not take into account the unique complications that are associated with pelvic reconstructive surgery. The objective of this study was to develop a peri- and postoperative complication scale that is specific to pelvic reconstructive surgery and to compare its ability to predict factors that are associated with perioperative morbidity with the Clavien-Dindo system.

      Materials and Methods

      Investigators from the Pelvic Floor Disorders Network and the Urinary Incontinence Treatment Network rated specific intraoperative plus immediate and delayed postoperative complications on a scale from 0-10 based on severity, patient bother, and duration of disability. Scoring was as follows: 0 = none, no bother, no clinical significance; 2 = minor, bother, no clinical significance, transient, self-limited; 4 = minor, bother, requires intervention; 6 = major, no risk or low risk, no long-term sequelae; 8 = major, moderate or high risk, long-term sequelae; and 10 = major, life threatening, permanent disability. We then created the Pelvic Floor Complication Scale (PFCS) using the information that we had obtained (Table 1).
      TABLE 1Pelvic Floor Complication Scale: peri- and postoperative morbidity with physician-rated complication severity levels
      MorbidityMeanSD
      Intraoperative (before leaving operating room)
       OR1: Bowel injury with colostomy8.20.7
       OR2: Bowel injury with resection and primary repair6.91.0
       OR3: Bowel injury with primary repair (does not include serotomy)5.91.4
       OR4: Vascular injury that requires vascular surgeon7.71.3
       OR5: Ureteral injury that requires reanastomosis7.00.9
       OR6: Ureteral injury that requires stent5.81.3
       OR7: Ureteral injury that is resolved with removal of suture4.41.6
       OR8: Aspiration pneumonia6.61.3
       OR9: Transfusion5.21.4
       OR10: Estimated blood loss >1000 mL5.31.7
       OR11: Urethral injury5.81.3
       OR12: Cystotomy that requires repair4.71.2
       OR13: Cystotomy that does not require repair3.11.2
      Immediately postoperation (after leaving operating room to discharge)
       IP1: Thromboembolic event (deep venous thrombosis/pulmonary embolism)8.01.4
       IP2: Small bowel obstruction7.01.2
       IP3: Ileus (reversal in diet advance)3.81.2
       IP4: Persistent nausea/vomiting >24 hours (cause uncertain)3.61.3
       IP5: Postoperative fever that requires antibiotics (cause uncertain)3.51.1
       IP6: Postoperative fever that resolves without antibiotics2.31.2
       IP7: Myocardial infarction/congestive heart failure8.61.0
       IP8: Wound infection with fascial dehiscence7.21.3
       IP9: Wound infection/separation with suprafascial dehiscence5.01.2
       IP10: Wound infection/seroma/hematoma with no dehiscence (cellulitis resolved with antibiotics)4.00.9
       IP11: Fistula7.51.3
       IP12: Neuropathy that is persistent at time of discharge6.01.6
       IP13: Neuropathy that resolves before discharge3.11.4
       IP14: Urinary tract infection (bacteriuria, pyuria, treated with antibiotics)3.31.1
       IP15: Bleeding: reoperation required7.31.1
       IP16: Bleeding: transfusion required5.31.3
       IP17: Bleeding: observation only3.41.4
       IP18: Reoperation because of an unrecognized bladder injury6.90.9
       IP19: Reoperation because of an unrecognized ureteral injury7.60.9
       IP20: Reoperation because of an unrecognized bowel injury8.31.0
       IP21: Reoperation because of any other complication of original surgery7.20.9
       IP22: Pneumonia5.71.4
       IP23: Pulmonary edema5.91.5
       IP24: Mental status changes6.01.6
       IP25: Pelvic abscess6.61.5
       IP26: Sepsis, disseminated intravascular coagulation9.01.1
      Delayed postoperative (after discharge)
       DP1: Thromboembolic event (deep venous thrombosis/pulmonary embolism)8.21.4
       DP2: Small bowel obstruction7.11.0
       DP3: Ileus (reversal in diet advance)4.61.4
       DP4: Persistent nausea/vomiting (cause uncertain)4.31.5
       DP5: Postoperative fever that requires antibiotics (cause uncertain)4.11.1
       DP6: Postoperative fever that resolves without antibiotics2.71.2
       DP7: Myocardial infarction/congestive heart failure8.61.1
       DP8: Wound infection with fascial dehiscence7.51.2
       DP9: Wound infection/separation with suprafascial dehiscence5.31.3
       DP10: Wound infection/seroma/hematoma - no dehiscence (cellulitis resolved with antibiotics)4.31.2
       DP11: Fistula7.61.1
       DP12: Urinary tract infection (bacteriuria, pyuria, treated with antibiotics)3.51.1
       DP13: Bleeding, reoperation required7.51.2
       DP14: Bleeding, transfusion required5.61.5
       DP15: Bleeding, observation only3.61.5
       DP16: Reoperation because of an unrecognized bladder injury7.01.1
       DP17: Reoperation because of an unrecognized ureteral injury7.71.2
       DP18: Reoperation because of an unrecognized bowel injury8.51.1
       DP19: Reoperation because of any other complication of original surgery7.41.0
       DP20: Pneumonia5.71.5
       DP21: Pulmonary edema5.91.5
       DP22: Mental status changes, dementia6.01.7
       DP23: Pelvic abscess6.71.4
       DP24: Sepsis, disseminated intravascular coagulation9.01.1
       DP25: Readmission secondary to a complication of original surgery6.31.4
       DP26: Graft erosion that requires surgical excision6.01.4
       DP27: Graft erosion trimmed in office4.11.1
       DP28: Graft erosion expectantly managed3.31.2
       DP29: Suture erosion3.51.1
       DP30: Urinary retention that requires surgical revision.6.11.3
       DP31: Prolonged urinary retention (>4 wk) that requires catheterization4.71.3
       DP32: Transient urinary retention (<4 wk)3.21.3
       DP33: Persistent neuropathy at (≥6 wk)7.11.5
       DP34: Granulation tissue3.11.2
      Disclaimer: This scale is not ready for clinical or research use in its current form. It is under revision; a simplified version will be published with instructions regarding usage once it has been validated.
      Gutman. The Pelvic Floor Complication Scale. Am J Obstet Gynecol 2013.
      PFCS scores were calculated retrospectively during the first postoperative year for participants in 2 randomized pelvic floor surgical trials: colpopexy and urinary reduction efforts (CARE), which compared abdominal sacrocolpopexy with or without Burch colposuspension in stress continent women
      • Brubaker L.
      • Cundiff G.W.
      • Fine P.
      • et al.
      Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence.
      and the stress incontinence surgical treatment efficacy trial (SISTEr), which compared Burch colposuspension and fascial sling in women with stress incontinence.
      • Albo M.E.
      • Richter H.E.
      • Brubaker L.
      • et al.
      Burch colposuspension versus fascial sling to reduce urinary stress incontinence.
      This analysis was exempt from Institutional Review Board review. We excluded women with no 3-month follow-up data. Complications for each study had been evaluated already, adjudicated, and transferred into a database. Information from these databases was extracted to help identify the complication onset, resolution, severity, and treatment. Definitions were created for each complication to use as a guide for cases in which the information from the database was insufficient to categorize the complication (Table 1). For example, clear, mutually exclusive definitions were constructed to distinguish wound infections with separation (suprafascial dehiscence) from seroma, hematoma, or cellulitis (without dehiscence and/or resolved with antibiotics). When a reoperation or readmission was required for a complication, the highest single PFCS score that was related to the complication was selected.
      Two independent investigators reviewed all complications that occurred during the first year after surgery in each study and assigned a time period and PFCS score. A third investigator adjudicated any discrepancies that occurred. There were 3 time periods: perioperative (operating room to discharge), 3 postoperative months (discharge to 90 days), and 1 postoperative year (91-365 days). Complications that were being actively managed over >1 time period generated a separate complication score for each time period. An example of this includes a vaginal mesh exposure that was trimmed in the office at 2 months and in the operating room at 6 months after the surgery. Individual complication scores for each time period were summed. We defined the PFCS composite score as the sum of all complications that occurred during the perioperative and 3-month postoperative time periods. Medical complications that were >6 weeks after surgery and were not believed by 3 reviewers to be related to the original surgery did not receive a PFCS score.
      Patient demographics that were collected included age, race, marital status, education, tobacco use, menopause status, previous pelvic surgery, diabetes mellitus, body mass index, and preoperative pelvic organ prolapse quantification examination stage. QoL measures that included the Health Utilities Index (HUI) for SISTEr, Short Form-36 Health Survey (SF-36) for CARE, and Urogenital Distress Inventory (UDI) and Incontinence Impact Questionnaire (IIQ) for both studies were available at baseline, 3 months, and 1 year. HUI ranged from 0-1; higher value indicate better health, but scores can also be negative (lowest possible value, −0.36), which reflects health states that are considered worse than death. The mental and physical component summary scores of the SF-36 range from 0–100 (higher scores indicate better health). UDI scores range from 0–300, and IIQ scores range from 0–400 (higher scores indicate worse QoL). Satisfaction was measured by a global satisfaction question with a 5-point Likert scale from “very dissatisfied” to “very satisfied” at 3 months and 1 year. Additionally, surgical information that included the route of surgery, type of anesthesia, length of surgery, and postoperative length of hospitalization (LOH) was obtained.
      Complications were also assessed with a modified Clavien-Dindo scale.
      • Dindo D.
      • Demartines N.
      • Clavien P.A.
      Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.
      The original Clavien-Dindo scale was validated for immediate postoperative complications before discharge in a general surgical population. The scale ranges from grade I-IV; higher scores indicate more severe complications. Grade I includes complications requiring no medications or specific medications and wound infections treated at the bedside. Grade II includes other medications, blood transfusions, and total parenteral nutrition. Grade III requires surgical, endoscopic, or radiologic management and grade IV involves life-threatening complications with intermediate or intensive care unit treatment. Grade V includes patient death.
      • Dindo D.
      • Demartines N.
      • Clavien P.A.
      Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.
      The modified version of this scale was used according to the original specifications with 1 exception: complications were also categorized during surgery and at time periods after discharge. Clavien-Dindo scores for SISTEr subjects were calculated for all delayed postoperative complications; Clavien-Dindo scores for CARE subjects were calculated for only those delayed postoperative complications that were believed to be associated with the original surgery.
      We then examined associations between PFCS composite scores and LOH, QoL, and satisfaction at 3 months with general linear fit models (LOH, HUI, and SF-36) and ordinal logistic regression for satisfaction. Because UDI and IIQ had a large proportion of subjects with 0 values, a 2-step analysis was run. The first step used a logistic model to evaluate the association between a PFCS composite score and a dichotomous UDI score (0 vs scores >0). The second step used a general linear model to evaluate the association between PFCS composite score and UDI score for all subjects with a UDI score >0 (log [e-base] transformed before analysis). Each analysis was adjusted for the corresponding baseline QoL scores when available (HUI, SF-36, UDI, and IIQ). We chose to analyze the 2 studies (CARE and SISTEr) as 1 combined group because the goal of this study was to evaluate the PFCS among various patients who had undergone reconstructive pelvic surgery. Because the 2 study populations and types of procedures were inherently different, we also adjusted each analysis for the study (CARE and SISTEr). We performed similar analyses for Clavien-Dindo score at 3 months. In addition, we examined associations between PFCS and Clavien-Dindo 1-year scores and 1-year outcomes. In all analyses, PFCS was treated as a continuous variable, and Clavien-Dindo was treated as a categoric variable. The associations for PFCS and Clavien-Dindo scores were compared with the use of Pearson and Spearman correlation coefficients (R-square) or Akaike Information Criterion. A probability value of < .05 was considered statistically significant.

      Results

      Scale development

      Forty-seven surgeons participated, which yielded a mean score and standard deviation for each complication (Table 1). The highest score was 9.0 for sepsis/disseminated intravascular coagulation and lowest 2.3 for postoperative fever that did not require antibiotics. Standard deviations ranged from 0.7–1.7 for all complications.

      Demographics and scale assessment

      Participants included 977 women (CARE, 322 women; SISTEr, 655 women); baseline characteristics and surgical information are listed in Table 2. Mean age was 55 years, and mean body mass index was 29 kg/m2. Most of the women were non-Hispanic white (79%), married (71%), and menopausal (75%) and had had pelvic surgery (70%). Most women had stage 2 or 3 prolapse (44% and 31%, respectively). Median LOH was 2 days (quartile range, 1–3 days). Table 3 contains the QoL measures at baseline, 3 months and 1 year plus satisfaction at 3 months and 1 year. All variables improved from baseline, and 90% of the women were somewhat or very satisfied at 3 months.
      TABLE 2Baseline characteristics and surgical information
      VariableMeasure
      Age, n
      Data are given as mean ± SD.
      54.9 ± 11.1
      Body mass index, kg/m2a29.0 ± 5.8
      Race, n (%)
       Non-Hispanic white774 (79.3)
       Hispanic81 (8.3)
       Non-Hispanic black60 (6.1)
       Non-Hispanic other61 (6.3)
      Marital status, n (%)
       Married or living as married687 (70.7)
       Separated, divorced, widowed285 (29.3)
      Education, n (%)
       Completed ≥4 years of college242 (24.8)
       Some college/Associate degree358 (36.6)
       Less than or equivalent to complete high school377 (38.6)
      Current tobacco use, n (%)116 (11.9)
      Menopause, n (%)
       After menopause735 (75.3)
       Before menopause241 (24.7)
      Previous pelvic surgery, n (%)684 (70)
      Diabetes mellitus, n (%)62 (6.3)
      Pelvic organ prolapse quantification examination, n (%)
       Stage 030 (3.1)
       Stage 1132 (13.5)
       Stage 2431 (44.1)
       Stage 3305 (31.2)
       Stage 479 (8.1)
      Surgery route, n (%)
       Combined abdominal and vaginal521 (53.3)
       Abdominal456 (46.7)
      Type of anesthesia, n (%)
       General851 (87.1)
       Other126 (12.9)
      Length of surgery, min
      Data are given as mean ± SD.
      151.4 ± 67.1
      Gutman. The Pelvic Floor Complication Scale. Am J Obstet Gynecol 2013.
      a Data are given as mean ± SD.
      TABLE 3Quality-of-life measures and satisfaction
      OutcomeBaseline3 mo1 y
      Urogenital Distress Inventory score
      Data are given as mean ± SD.
      121.7 ± 62.5 (n = 966)29.5 ± 36.9 (n = 900)29.0 ± 37.4 (n = 816)
      Incontinence Impact Questionnaire score
      Data are given as mean ± SD.
      136.6 ± 104.7 (n = 968)43.8 ± 73.6 (n = 900)27.5 ± 56.3 (n = 814)
      Health Utilities Index score
      Data are given as mean ± SD.
      0.7 ± 0.3 (n = 648)0.8 ± 0.2 (n = 633)0.8 ± 0.3 (n = 512)
      Short Form-36 score
      Data are given as mean ± SD.
       Physical45.4 ± 9.647.0 ± 8.849.3 ± 9.3
       Mental51.9 ± 8.9 (n = 315)53.0 ± 9.3 (n = 304)53.1 ± 8.8 (n = 304)
      Satisfaction, n (%)
       Very satisfied607 (68.0)556 (68.2)
       Somewhat satisfied196 (21.9)166 (20.4)
       Neither satisfied nor dissatisfied27 (3.0)22 (2.7)
       Somewhat dissatisfied36 (4.0)52 (6.4)
       Very dissatisfied27 (3.0)19 (2.3)
      Gutman. The Pelvic Floor Complication Scale. Am J Obstet Gynecol 2013.
      a Data are given as mean ± SD.
      At 3 months, the mean PFCS composite score was 2.1 ± 3.6, and 63% of the women did not have any complications (score, 0). For the same time period, 57% of the women were assigned a modified Clavien-Dindo grade 0; 9% were assigned grade 1; 29% were assigned grade 2; 4% were assigned grade 3; and 1% were assigned grade 4. TABLE 4, TABLE 5 show the results of the association analysis between LOH, QoL, and satisfaction and Clavien-Dindo and PFCS scores at 3 months. Results from linear and logistic regression are included in each table. Because of limited space, we did not show the effect of confounders that were controlled in each model (ie, study effect and baseline QoL scores). At 3 months, higher PFCS scores were associated with longer LOH (P < .01) and decreased QoL outcomes: lower HUI (P < .01), lower SF-36 physical component summary score (P = .03), higher pelvic floor symptom distress and impact (UDI [P < .01], IIQ [P < .01]), and lower satisfaction (P < .01). Clavien-Dindo scores were associated with LOH (P < .01), HUI (P < .01), SF-36 physical component summary score (P = .02), UDI (P = .02), IIQ (P = .04), and satisfaction (P < .01). The SF-36 mental component summary score was not associated significantly with either PFCS composite score or modified Clavien-Dindo score at 3 months. The PFCS composite and modified Clavien-Dindo scores are very similar in terms of their association with LOH, QoL measures, and satisfaction when R-square (0.74 to 0.93 at 3 months and 1 year) and Akaike Information Criterion values are compared. Neither the PFCS nor the modified Clavien-Dindo scores were associated with any of the 1 -year postoperative outcomes (LOH, QoL, or satisfaction).
      TABLE 4Associations between scales with length of hospitalization, quality of life, and satisfaction and 3 month outcome measures
      VariableLength of hospitalization: regression coefficient (95% CI)
      Linear regression;
      Health Utilities Index: regression coefficient (95% CI)
      Linear regression;
      Short Form-36: regression coefficient (95% CI)
      Linear regression;
      Satisfaction: odds ratio (95% CI)
      Ordinal logistic model;
      MentalPhysical
      Clavien-Dindo score (0 as reference)
       Grade IV3.9 (3.1–4.8)−0.2 (−0.4 to 0.04)−6.7 (−18.1 to 4.8)−1.3 (−11.6 to 9.0)0.3 (0.1–1.2)
       Grade III0.7 (0.4–1.1)−0.02 (−0.1 to 0.1)−3.0 (−6.8 to 0.8)−0.7 (−4.1 to 2.7)0.2 (0.1–0.4)
       Grade II0.5 (0.4–0.7)−0.03 (−0.1 to 0)−1.7 (−4.0 to 0.7)−2.6 (−4.7 to −0.5)0.7 (0.5–0.9)
       Grade I0.2 (−0.1 to 0.4)−0.1 (−0.1 to 0)−1.1 (−4.2 to 1.9)−4.1 (−6.8 to −1.4)0.7 (0.4–1.1)
      P value
      For linear regression, this is the probability value for the omnibus F-test; for ordinal logistic models, this is the probability value for the Wald χ2 statistics.
      < .01< .01.29.02< .01
      Pelvic Floor Complication Scale
       Change per 10 units of Pelvic Floor Complication Scale score1.1 (0.9–1.3)−0.1 (−0.1 to −0.05)−1.7 (−4.4 to 1.0)−2.7 (−5.3 to −0.2)0.5 (0.4–0.7)
      P value< .01< .01.21.03< .01
      CI, confidence interval.
      Gutman. The Pelvic Floor Complication Scale. Am J Obstet Gynecol 2013.
      a Linear regression;
      b Ordinal logistic model;
      c For linear regression, this is the probability value for the omnibus F-test; for ordinal logistic models, this is the probability value for the Wald χ2 statistics.
      TABLE 5Associations between scales with UDI and the IIQ and 3 month outcome measures
      VariableUrogenital Distress InventoryIncontinence Impact Questionnaire
      >0 vs = 0
      Linear model: odds ratio (95% CI);
      >0
      Linear regression: exp(regression coefficient) (95% CI); these analyses were based on log (e-base) transformed scores and the listed numbers should be interpreted as multiplicative effect (for instance, among those who had Urogenital Distress Inventory scores of >0, the mean score of Urogenital Distress Inventory for a subjects whose Clavien-Dindo grade equals IV is approximately 2.2 times as high as those whose Clavien-Dindo grade equals 0);
      >0 vs = 0
      Linear model: odds ratio (95% CI);
      >0
      Linear regression: exp(regression coefficient) (95% CI); these analyses were based on log (e-base) transformed scores and the listed numbers should be interpreted as multiplicative effect (for instance, among those who had Urogenital Distress Inventory scores of >0, the mean score of Urogenital Distress Inventory for a subjects whose Clavien-Dindo grade equals IV is approximately 2.2 times as high as those whose Clavien-Dindo grade equals 0);
      Clavien-Dindo grade (0 as reference)
       IV0.45 (0.1–2.7)2.2 (0.7–6.8)2.1 (0.7–6.2)2.9 (0.3–33.0)
       III9.0 (1.2–66.8)1.4 (0.9–2.3)1.4 (1.0–2.0)2.1 (0.8–5.3)
       II1.7 (1.1–2.6)1.3 (1.0–1.6)1.2 (1.0–1.4)1.3 (0.9–2.1)
       I1.3 (0.7–2.6)1.3 (0.9–1.9)1.0 (0.7–1.3)0.8 (0.5–1.4)
      P value
      for linear regression, this is the probability value for the omnibus F-test; for logistic regression, this is the probability value for the Wald χ2 statistics.
      .02.12.11.11
      Pelvic Floor Complication Scale
       Odds ratio for 10 units change of Pelvic Floor Complication Scale score1.5 (0.8–2.4)1.5 (1.1–2.0)1.3 (1.1–1.7)1.6 (1.0–2.4)
      P value.19< .01< .01.02
      CI, confidence interval; IIQ, Incontinence Impact Questionnaire; UDI, Urogenital Distress Inventory.
      Gutman. The Pelvic Floor Complication Scale. Am J Obstet Gynecol 2013.
      a Linear model: odds ratio (95% CI);
      b Linear regression: exp(regression coefficient) (95% CI); these analyses were based on log (e-base) transformed scores and the listed numbers should be interpreted as multiplicative effect (for instance, among those who had Urogenital Distress Inventory scores of >0, the mean score of Urogenital Distress Inventory for a subjects whose Clavien-Dindo grade equals IV is approximately 2.2 times as high as those whose Clavien-Dindo grade equals 0);
      c for linear regression, this is the probability value for the omnibus F-test; for logistic regression, this is the probability value for the Wald χ2 statistics.

      Comment

      This study was undertaken because current validated surgical complication scales do not capture the magnitude and consequence of complications for women who undergo pelvic reconstructive surgery for prolapse and urinary incontinence. Therefore, a group of expert pelvic surgeons who are participating in large, multicenter clinical trials developed a new measure of surgical complications that is intended to reflect bother, severity, and duration of disability in women as continuous measures both during surgery and for 3 months after surgery. It is designed for all routes of pelvic surgery (vaginal, laparoscopic/robotic, and open) and characterizes unique complications that have been encountered with prolapse and incontinence procedures, which includes those that involve blind passes of trocars and prosthetic graft material, which are not measured in currently validated surgery complication scales.
      The Clavien-Dindo scale is the best described surgical complication classification scale to categorize perioperative complications reliably and to facilitate comparison of surgical outcomes; however, it is oriented to general surgery procedures.
      • Clavien P.
      • Sanabria J.
      • Strasberg S.
      Proposed classification of complication of surgery with examples of utility in cholecystectomy.
      Although this scale has many strengths, we were concerned that it may not reflect the complication profile of pelvic reconstructive procedures, which generally are performed electively on medically optimized women as an outpatient (same day) surgery or with short (1- to 2-day) inpatient hospitalization. Additionally, the Clavien-Dindo scale was validated in a cohort of men and women, but women often rated complications as less severe than men, which suggests that the scale may perform differently in women.
      • Clavien P.A.
      • Barkun J.
      • de Oliveria M.L.
      • et al.
      The Clavien-Dindo classification of surgical complications: five-year experience.
      Our study shows that the Clavien-Dindo scale performed similarly to a more specific scale (PFCS). This is reasonable because surgical complications have some common denominator.
      On face value, the categoric Clavien-Dindo scale seemed less conducive to comparison of morbidity among urogynecologic procedures. For example, urinary tract infection (a common complication after pelvic reconstructive surgery) is scored disproportionately higher on the scale than wound complications. We intended to develop a morbidity scale that ultimately could be used to compare traditional and emerging technologies and approaches comprehensively. The CARE and SISTEr studies involved traditional surgeries but did not compare them to emerging technologies and minimally invasive approaches. Future evaluation of the PFCS in women who undergo transvaginal mesh repair or laparoscopic sacral colpopexy may prove valuable. This is highly relevant in light of recent Food and Drug Administration warnings about the transvaginal use of mesh for prolapse procedures.
      Food and Drug Administration
      FDA Safety Communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse.
      The CARE and SISTEr trial datasets of clinical and QoL outcomes provided an opportunity to calculate PFCS scores retrospectively on well-characterized populations of women who had had pelvic surgery for urinary incontinence and/or prolapse. The calculated composite PFCS score was associated with clinical measures that reflected adverse outcomes that included longer LOH, decreased QoL, and decreased overall satisfaction at 3 months. However, we were surprised to find that the enhanced complication details that were provided by the PFCS did not strengthen associations with bother and QoL measures at 3 months, when compared with the modified Clavien-Dindo scale. Both scales showed limited overall predictive value. The moderate association may reflect discordance between surgeon-designed measures of morbidity and the patients' subjective experience and tolerance of the complication. Clavien et al
      • Clavien P.A.
      • Barkun J.
      • de Oliveria M.L.
      • et al.
      The Clavien-Dindo classification of surgical complications: five-year experience.
      found important differences in physician and patient perceptions of complication severity when they asked physicians and patients to score 30 hypothetic scenarios on a numeric rating scale from 0-100. Patients perceived many complications to be more severe than did physicians. In another prospective study, patients were more likely to consider events to be complications compared with surgeons (44% of patients vs 8% of surgeons reported a perioperative complication).
      • Kenton K.
      • Pham T.
      • Mueller E.
      • Brubaker L.
      Patient preparedness: an important predictor of surgical outcome.
      Patients frequently cited common perioperative events, such as constipation and temporary urinary catheterization, to be complications.
      The PFCS and Clavien-Dindo scales had similar associations with clinical measures of morbidity and QoL. The authors who generated the respective scores considered the modified Clavien-Dindo scale to be easier to apply. They found the assignment of PFCS scores to be complex, especially in the setting of wound complications because nearly 25% of the PFCS scores required adjudication. The retrospective acquisition of morbidity details may have contributed to their difficulty.
      The potential strength of this PFCS measure is that it is oriented specifically towards pelvic reconstructive surgery in women. We believe it more accurately classifies urinary tract infections and gives greater weight to wound complications, especially vaginal mesh exposure, and to the sequelae of dyspareunia and other types of pelvic pain, regardless of implementation of therapy for the pain. However, its potential as a sensitive tool with prospective use in comparative studies has yet to be determined.
      The specific nature of the PFCS may limit its ability to compare complications across different surgical disciplines that are relative to the Clavien-Dindo scale. Another limitation involves the more complex statistical analysis that is required to compare a continuous scale (PFCS) to a categoric scale (Clavien-Dindo), which may be more difficult to understand. We believed it important to analyze the PFCS in the way in which it was intended to be used, as a continuous scale score with a cumulative complication effect. We believe that this will reflect the overall severity and patient bother better, but we must investigate this further using patient-centered outcomes.
      Although the PFCS items and scoring system were developed by 47 surgeons, the scale was not tested further in a general population of surgeons before we used it in our study. Further, our results may not be generalizable for other populations because the SISTEr and CARE populations are predominantly white, married, educated, and nonsmokers. Generic QoL measures were not the same in both studies. The surgical approaches in the 2 trials did not include today's more commonly performed synthetic mesh mid urethral slings, vaginal mesh or graft placement, or minimally invasive robotic and laparoscopic approaches to sacral colpopexy.
      Future prospective studies are necessary to evaluate and validate the scale.
      To improve the utility and applicability of the PFCS, future developmental efforts should simplify the measure and still incorporate outpatient treatment of complications. It would be reasonable to shorten the PFCS scale by collapsing the immediate and delayed postoperative complication categories because we collect the timing of the complication; most of the 24 overlapping complications have similar scores. We also would include complications that are omitted among the initial 73 complication that are included (such as emergency room or unplanned office visits) and factor in patients' perceptions of complications. The assignment of PFCS score prospectively will provide information on the ease of use and reproducibility. Because most of the complications occurred within the first 3 months after surgery and 12-month scores were not correlated with QoL measures, we recommend that the composite 3-month score be the sole score.
      In summary, despite the fact that the Clavien-Dindo scale does not account for complications that are diagnosed after discharge, both the PFCS and modified Clavien-Dindo scale seemed to possess similar associations with the outcomes that were tested in women during the initial 3 months after pelvic reconstructive surgery. Based on our results, the modified Clavien-Dindo scale appears to be a useful complication scale in women who undergo and for 3 months after pelvic reconstructive surgery. This initial version of the PFCS has the potential to reflect complications that are specific to pelvic floor surgery, compared with the Clavien-Dindo scale. Further refinements to the scale are planned to streamline its use prospectively in future trials.

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