J Eric Jelovsek

Cleveland Clinic, Cleveland, Ohio, United States

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Publications (76)273.85 Total impact

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    ABSTRACT: OBJECTIVE: To construct and validate models that predict a patient's risk of developing stress and urgency urinary incontinence and adverse events 12 months after sling surgery. METHODS: This was a secondary analysis of four randomized trials. Twenty-five candidate predictors (patient characteristics and urodynamic variables) were identified from the National Institute of Diabetes and Digestive and Kidney Diseases Trial of Mid-Urethral Slings (N=597). Multiple logistic models were fit to predict four different outcomes: 1) bothersome stress urinary incontinence; 2) a positive stress test; 3) bothersome urgency urinary incontinence; and 4) any adverse event up to 12 months after sling surgery. Model discrimination was measured using a concordance index. Each model's concordance index was internally validated using 1,000 bootstrap samples and calibration curves were plotted. Final models were externally validated on a separate data set (n=902) from a combination of three different multicenter randomized trials. RESULTS: Four best models discriminated on internal validation between women with bothersome stress urinary incontinence (concordance index 0.728, 95% confidence interval [CI] 0.683-0.773), a positive stress test (concordance index 0.712, 95% CI 0.669-0.758), bothersome urgency urinary incontinence (concordance index 0.722, 95% CI 0.680-0.764), and any adverse event (concordance index 0.640, 95% CI 0.595-0.681) after sling surgery. Each model's concordance index was reduced as expected when important variables were removed for external validation, but model discrimination remained stable with bothersome stress urinary incontinence (concordance index 0.548), a positive stress test (concordance index 0.656), bothersome urgency urinary incontinence (concordance index 0.621), and any adverse event (concordance index 0.567). Predicted probabilities are closest to actual probabilities when predictions are less than 50%. CONCLUSION: Four best and modified models discriminate between women who will and will not develop urinary incontinence and adverse events 12 months after midurethral sling surgery 64-73% and 55-66% of the time, respectively.
    No preview · Article · Jan 2016 · Obstetrics and Gynecology
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    ABSTRACT: Objectives: Medication adherence with urgency urinary incontinence (UUI) treatment is challenging and the best assessment methodology is uncertain. We sought to describe adherence with anticholinergic (AC) versus placebo (P) by comparing pill counts and MEMSCAP event data and to identify factors associated with adherence. Methods: The randomized controlled AC versus Botox Comparison trial of women with moderate to severe idiopathic UUI included 126 participants initiating AC plus P bladder injection and 121 receiving P pills plus Botox injection. Adherence data on 243 participants (124 AC and 119 P) were calculated by pill count and MEMSCAP data for each 2-month interval during the 6-month study that allowed for dose escalation/drug change. Overall composite adherence estimates were calculated using the average of both methods and weighted by the duration of each 2-month interval. Results: Treatment groups had no significant differences in dosing duration (P = 0.76) or mean adherence (AC, 83.3% [16.8] vs P, 84.8% [13.8]). Only 53% of women met the dichotomous outcome of more than 80% adherence during all intervals. Correlation between adherence by pill counts versus MEMSCAP decreased over time with pill counts demonstrating higher adherence than MEMSCAP (r = 0.53, 0.50, and 0.36 for each 2-month interval). Lower adherence was associated with higher baseline incontinence severity and better UUI quality of life for the AC group and with current smoking status in both groups. Conclusions: Adherence using pill counts and MEMSCAP was reasonably correlated and similar in both the AC and P groups. In the AC group, higher baseline incontinence severity and better UUI Quality of Life were associated with decreased adherence. Smokers were less adherent.
    No preview · Article · Oct 2015
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    ABSTRACT: The goals of this trial are to determine the efficacy and safety of two treatments for women experiencing fecal incontinence. First, we aim to compare the use of loperamide to placebo and second, to compare the use of anal sphincter exercises with biofeedback to usual care. The primary outcome is the change from baseline in the St. Mark's (Vaizey) Score 24weeks after treatment initiation. As a Pelvic Floor Disorders Network (PFDN) trial, subjects are enrolling from eight PFDN clinical centers across the United States. A centralized data coordinating center supervises data collection and analysis. These two first-line treatments for fecal incontinence are being investigated simultaneously using a two-by-two randomized factorial design: a medication intervention (loperamide versus placebo) and a pelvic floor strength and sensory training intervention (anal sphincter exercises with manometry-assisted biofeedback versus usual care using an educational pamphlet). Interventionists providing the anal sphincter exercise training with biofeedback have received standardized training and assessment. Symptom severity, diary, standardized anorectal manometry and health-related quality of life outcomes are assessed using validated instruments administered by researchers masked to randomized interventions. Cost effectiveness analyses will be performed using prospectively collected data on care costs and resource utilization. This article describes the rationale and design of this randomized trial, focusing on specific research concepts of interest to researchers in the field of female pelvic floor disorders and all other providers who care for patients with fecal incontinence. Copyright © 2015. Published by Elsevier Inc.
    No preview · Article · Aug 2015 · Contemporary clinical trials

  • No preview · Article · Aug 2015 · Obstetrical and Gynecological Survey
  • J Eric Jelovsek

    No preview · Article · Jul 2015 · Medical Education
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    ABSTRACT: This study aimed to describe the incidence of fecal incontinence (FI) at 6, 12, and 24 weeks postpartum; anal incontinence (AI) and fecal urgency at 24 weeks; and identify predictors of AI in women with obstetric anal sphincter injury (OASI). Primiparous women sustaining OASIs were identified at 8 clinical sites. Third-degree OASIs were characterized using World Health Organization criteria, 3a (<50%) or 3b (>50%) tear through the sphincter. Fecal incontinence was defined as leakage of liquid/solid stool and/or mucus in the past month; AI was defined as leakage of liquid/solid stool and/or mucus and/or gas in the past month and was assessed at 6, 12, and 24 weeks postpartum using the Fecal Incontinence Severity Index. Logistic regression identified variables associated with AI. Three hundred forty-three women participated: 297 subjects sustained a third-degree OASI, 168 type 3a, 98 type 3b and 31 indeterminant; 45 had a fourth-degree OASI. Overall FI incidence at 6, 12, and 24 weeks was 7% [23/326; 95% confidence interval (CI), 4%-10%], 4% (6/145; 95% CI, 2%-9%), and 9% (13/138; 95% CI, 5%-16%), respectively. At 24 weeks, AI incidence was 24% (95% CI, 17%-32%) and fecal urgency 21% (95% CI, 15%-29%). No significant differences in FI and AI rates were noted by third-degree type or between groups with third and fourth OASI. Flatal incontinence was greater in women sustaining a fourth-degree tear (35% vs 16%, P = 0.04). White race (adjusted odds ratio, 4.64; 95% CI, 1.35-16.02) and shorter duration of second stage (adjusted odds ratio, 1.47 per 30 minute decrease; 95% CI, 1.12-1.92) were associated with AI at 24 weeks. Overall 24-week incidence of FI is 9% (95% CI, 5%-16%) and AI is 24% (95% CI, 17%-32%). In women with OASI, white race and shorter second-stage labor were associated with postpartum AI.Clinical Trial Registration: NCT01166399 (http://clinicaltrials.gov).
    No preview · Article · Jan 2015 · Journal of Pelvic Medicine and Surgery

  • No preview · Article · Jan 2015

  • No preview · Article · Jan 2015 · Journal of Pelvic Medicine and Surgery
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    ABSTRACT: Posterior pelvic organ prolapse (pPOP) commonly occurs with apical prolapse, other vaginal compartment defects, and symptoms of defecatory dysfunction including obstructed defecation (OD). The indication for concomitant posterior repair (PR) during apical prolapse repair may be based on the presence or absence of symptoms. Some surgeons do not perform PR during repair of apical prolapse in the absence of symptoms. The Extended Colpopexy and Urinary Reduction Efforts (E-CARE) trial assessed the progression of posterior compartment prolapse and symptoms of OD after open abdominal sacrocolpopexy (ASC). Data from that study have been published in the primary article (Nygaard, JAMA 2013;309:2016). This secondary analysis of E-CARE data assessed the occurrence of pPOP and symptoms of OD in patients 5 years after open ASC. The study was designed to determine whether PR is necessary at the time of ASC. Participants with baseline and 5-year outcome data were divided into 3 groups using baseline posterior Pelvic Organ Prolapse Quantification points and concomitant PR: (1) no PR, Ap < 0; (2) no PR, Ap ≥ 0; and (3) +PR. Decision for concomitant PR was performed at the surgeon’s discretion and included posterior colporrhaphy, perineorrhaphy, or sacrocolpoperineopexy. Five-year outcomes were dichotomized into presence/absence of pPOP (Ap > 0) and OD symptoms of moderate or greater bother (≥2) on 1 or more Pelvic Floor Distress Inventory questions about digital assistance, excessive straining, or incomplete evacuation. Composite failure during the 5-year interval was defined by both pPOP and OD symptoms or pPOP reoperation. Completed baseline and 5-year outcomes were available for 90 participants (60%); mean (SD) follow-up was 7.1 (1.0) years. At 5 years, only 2 women (6%) with no PR (AP < 0) developed de novo pPOP with OD symptoms; 1 of these underwent subsequent PR. Without PR repair, nearly all participants (23/24; 96%) demonstrated sustained resolution of pPOP, and none underwent PR within 5 years. Obstructed defecation symptoms improved in all groups after ASC with or without PR, although OD symptoms were still present at 5 years, with rates ranging from 17% to 19%. Regardless of concomitant PR, symptomatic pPOP is common 5 years after ASC. Obstructed defecation symptoms may improve after ASC with or without PR. Additional studies are needed to define criteria for performing PR at the time of planned ASC.
    No preview · Article · Dec 2014 · Obstetrical and Gynecological Survey
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    ABSTRACT: To describe peri- and postoperative adverse events associated with uterosacral colpopexy, to describe the rate of recurrent POP associated with uterosacral colpopexy, and to determine whether surgeon technique and suture choice are associated with these rates. This was a retrospective chart review of women who underwent uterosacral colpopexy for pelvic organ prolapse (POP) between January 2006 and December 2011 at a single tertiary care center. The electronic medical record was queried for demographic, intra- and postoperative data. Strict definitions were used for all clinically relevant adverse events. Recurrent POP was defined as the following: symptomatic vaginal bulge, prolapse to or beyond the hymen, or any retreatment for POP. 983 subjects met study inclusion criteria. The overall adverse event rate was 31.2% (95%CI 29.2, 38.6), which included 20.3% (95%CI 17.9,23.6) of subjects with postoperative urinary tract infections. 3.4% of all adverse events were attributed to a pre-existing medical condition, while all other events were ascribed to the surgical intervention. Vaginal hysterectomy, age and operative time were not significantly associated with any adverse event. The intra-operative bladder injury rate was 1% (95%CI 0.6,1.9) and there were no intra-operative ureteral injuries; 4.5% (95%CI 3.4,6.0) of cases were complicated by ureteral kinking requiring suture removal. The rates of pulmonary and cardiac complications were 2.3% (95%CI 1.6,3.5) and 0.8% (95%CI 0.4,1.6); and the rates of postoperative ileus and small bowel obstruction were 0.1% (95%CI 0.02,0.6) and 0.8% (95%CI 0.4,1.6). The composite recurrent POP rate was 14.4% (95%CI 12.4,16.8): 10.6% (95%CI 8.8,12.7) of patients experienced vaginal bulge symptoms, 11% (95%CI 9.2,13.1) presented with prolapse to or beyond the hymen, and 3.4% (95%CI 2.4,4.7) required retreatment. Number and type of suture used were not associated with a higher rate of recurrence. Of the subjects who required unilateral removal of sutures to resolve ureteral kinking, 63.6% did not undergo suture replacement; this was not associated with a higher rate of POP recurrence. Peri- and postoperative complication rates associated with severe morbidity after uterosacral colpopexy appear to be low. Uterosacral colpopexy remains a safe option for the treatment of vaginal vault prolapse. Copyright © 2014 Elsevier Inc. All rights reserved.
    No preview · Article · Nov 2014 · American Journal of Obstetrics and Gynecology
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    ABSTRACT: The objective of this study was to compare the standard back-fill voiding trial that relies on the assessment of voided volume to subjective patients' evaluation of their voiding based on the assessment of the force of stream after an outpatient midurethral sling surgery. This double-blinded randomized trial included patients undergoing an outpatient mid-urethral sling surgery without any other concomitant surgery. Participants were randomized to either the Standard Voiding Trial (SVT) group or to the Force of Stream (FOS) group. The primary outcome was the rate of catheterization any time up to 6 weeks after surgery. Both groups underwent the same 'back-fill' voiding trial protocol postoperatively. Measurements of the voided amount, post-void residual and the response to the FOS visual analog scale were collected. The criteria for passing the voiding trial in the SVT group were voiding at least 2/3rd of the instilled amount; while the criteria for passing the trial in the FOS group was assessment of force of stream at least 50% of the baseline, regardless of the voided volume. Participants were interviewed pre-operatively and 2-4, 7-9 days and 6 weeks postoperatively. All post-operative interviews included assessments of pain, tolerance of physical activity, force of the urinary stream, as well as satisfaction with the surgery. Validated questionnaires (ISI and UDI-6) before the surgery and 6 weeks after were used to evaluate urinary symptoms. A total of 108 patients were enrolled and randomized, and 6 weeks follow up data were available for 102 participants (FOS: 50, SVT: 52). The two groups were similar with respect to demographic characteristics and urinary symptoms. The incidence of catheterization was also similar between the groups (FOS: 13 (26%), SVT: 13 (25.5%); p=0.95). Amount voided had a moderate correlation with FOS assessment (Spearman rho 0.5; p<0.001). There was no significant difference in the mean catheter days, pain scores, ISI, and UDI-6 scores between the two groups. Of the patients who were discharged home without a catheter in either group none required catheter reinsertion within 6 weeks after the surgery. Patient's subjective assessment of the force of the urinary stream correlated well with the measured voided amount and no difference in catheterization days was noted between the subjective and objective assessment of voiding. Thus subjective evaluation of the force of stream is a reliable and safe method to use after outpatient midurethral surgery. Copyright © 2014 Elsevier Inc. All rights reserved.
    No preview · Article · Nov 2014 · American Journal of Obstetrics and Gynecology
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    ABSTRACT: Objectives: The objective of this study was to estimate the minimum important difference (MID) for the Fecal Incontinence Severity Index (FISI), the Colorectal-Anal Distress Inventory (CRADI) scale of the Pelvic Floor Distress Inventory, the Colorectal-Anal Impact Questionnaire (CRAIQ) scale of the Pelvic Floor Impact Questionnaire, and the Modified Manchester Health Questionnaire (MMHQ). Methods: We calculated the MIDs using anchor-based and distribution-based approaches from a multicenter prospective cohort study investigating adaptive behaviors among women receiving nonsurgical and surgical management for fecal incontinence (FI). Patient responses were primarily anchored using a Global Impression of Change scale. The MID was defined as the difference in mean change from baseline between those who indicated they were "a little better" and those who reported "no change" on the Global Impression of Change scale 3 months after treatment. The effect size and SE of measurement were the distribution methods used. Results: The mean changes (SD) in FISI, CRADI, CRAIQ, and MMHQ scores from baseline to 3 months after treatment were -8.8 (12.0), -52.7 (70.0), -60.6 (90.0), and -12.6 (19.2), respectively. The anchor-based MID estimates suggested by an improvement from no change to a little better were -3.6, -11.4 and -4.7, -18.1 and -8.0, and -3.2 for the FISI, CRADI (long and short version), CRAIQ (long and short version), and MMHQ, respectively. These data were supported by 2 distribution-based estimates. Conclusions: The MID values for the FISI are -4, CRADI (full version, -11; short version, -5), CRAIQ (full version, -18; short version, -8), and MMHQ -3. Statistically significant improvements that meet these thresholds are likely to be clinically important.
    No preview · Article · Sep 2014 · Journal of Pelvic Medicine and Surgery
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    ABSTRACT: Objectives: The objective of this study was to describe posterior prolapse (pPOP) and obstructed defecation (OD) symptoms 5 years after open abdominal sacrocolpopexy (ASC). Methods: We grouped the extended colpopexy and urinary reduction efforts trial participants with baseline and 5-year outcomes into 3 groups using baseline posterior Pelvic Organ Prolapse Quantification (POP-Q) points and concomitant posterior repair (PR) (no PR, Ap <0; no PR, Ap ≥0; and +PR). Posterior colporrhaphy, perineorrhaphy, or sacrocolpoperineopexy were included as PR, which was performed at surgeon's discretion. Outcomes were dichotomized into presence/absence of pPOP (Ap ≥0) and OD symptoms (≥2 on 1 or more questions about digital assistance, excessive straining, or incomplete evacuation). Composite failure was defined by both pPOP and OD symptoms or pPOP reoperation. Results: Ninety participants completed baseline and 5-year outcomes or were retreated with mean follow-up of 7.1 ± 1.0 years. Of those with no PR (Ap <0), 2 women (2/36; 9%) developed new pPOP with OD symptoms; 1 underwent subsequent PR. Nearly all (23/24; 96%) with no PR (Ap ≥0) demonstrated sustained resolution of pPOP, and none underwent PR. Fourteen percent (4/29) of +PR underwent repeat PR within 5 years, and 12% had recurrent pPOP. Regardless of PR, OD symptoms improved in all groups after ASC, although OD symptoms were still present in 17% to 19% at 5 years. Conclusions: Symptomatic pPOP is common 5 years after ASC regardless of concomitant PR. Obstructed defecation symptoms may improve after ASC regardless of PR. Recurrent pPOP and/or reoperation was highest among those who received concomitant PR at ASC. Further studies identifying criteria for concomitant PR at the time of ASC are warranted.
    Full-text · Article · Sep 2014 · Journal of Pelvic Medicine and Surgery

  • No preview · Conference Paper · Aug 2014
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    ABSTRACT: Objective: To measure surgical judgment across the Obstetrics and Gynecology (OBGYN) continuum of practice and identify factors that correlate with improved surgical judgment. Methods: A 45-item written examination was developed using script concordance theory, which compares an examinee's responses to a series of "ill-defined" surgical scenarios to a reference panel of experts. The examination was administered to OBGYN residents, Female Pelvic Medicine and Reconstructive Surgery (FPMRS) fellows, practicing OBGYN physicians and FPMRS experts. Surgical judgment was evaluated by comparing scores against the experts. Factors related to surgical experience were measured for association with scores. Results: In total, 147 participants including 11 residents, 37 fellows, 88 practicing physicians and 11 experts completed the 45-item examination. Mean scores for practicing physicians (65.2 ± 7.4) were similar to residents (67.2 ± 7.1), and worse than fellows (72.6 ± 4.2, p < 0.001) and experts (80 ± 5, p < 0.001). Positive correlations between scores and surgical experience included: annual number of vaginal hysterectomies (r = 0.32, p = <0.001), robotic hysterectomies (r = 0.17, p = 0.048), stress incontinence (r = 0.29, p < 0.001) and prolapse procedures (r = 0.37, p < 0.001). Inverse correlation was seen between test scores and years in practice. (r = -0.19, p = 0.02). Conclusion: Intraoperative judgment in practicing OBGYN physicians appears similar to resident physicians. Practicing physicians who perform FPMRS procedures perform poorly on this examination of surgical judgment; lower performance correlates with less surgical experience and the greater amount of time in practice.
    No preview · Article · May 2014 · Medical Teacher

  • No preview · Article · Mar 2014 · Journal of Minimally Invasive Gynecology
  • C A Unger · H B Goldman · J E Jelovsek
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    ABSTRACT: Fecal incontinence is the involuntary loss of solid or liquid stool. While the true prevalence of fecal incontinence is difficult to discern, it is estimated that almost 9 % of non-institutionalized women in the US experience this condition. Disorders leading to fecal urgency alone are usually related to rectal storage abnormalities while incontinence is often a result of anatomic or neurologic disruption of the anal sphincter complex. Many risk factors exist for fecal incontinence and include female sex, increasing age, higher body mass index (BMI), limited physical activity, smoking, presence of neuropsychiatric conditions, higher vaginal parity and history of obstetrical trauma, presence of chronic diarrhea and irritable bowel syndrome, or history of rectal surgery, prostatectomy and radiation. Evaluation of fecal incontinence involves a careful patient history and focused physical exam. Diagnostic tests include endorectal ultrasonography, anal manometry, anal sphincter electromyography, and defecography. Treatment strategies include behavioral, medical and surgical therapies as well as neuromodulation. Treatment is based on the presumed etiology of the condition and a multi-modal approach is often necessary to achieve the maximum benefit for patients.
    No preview · Article · Mar 2014 · Current Urology Reports
  • C.A. Unger · N. Kow · J. Jelovsek

    No preview · Article · Mar 2014 · Journal of Minimally Invasive Gynecology
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    ABSTRACT: To construct and validate a prediction model for estimating the risk of de novo stress urinary incontinence (SUI) after vaginal pelvic organ prolapse (POP) surgery and compare it with predictions using preoperative urinary stress testing and expert surgeons' predictions. Using the data set (n=457) from the Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial, a model using 12 clinical preoperative predictors of de novo SUI was constructed. De novo SUI was determined by Pelvic Floor Distress Inventory responses through 12 months postoperatively. After fitting the multivariable logistic regression model using the best predictors, the model was internally validated with 1,000 bootstrap samples to obtain bias-corrected accuracy using a concordance index. The model's predictions were also externally validated by comparing findings against actual outcomes using Colpopexy and Urinary Reduction Efforts trial patients (n=316). The final model's performance was compared with experts using a test data set of 32 randomly chosen Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial patients through comparison of the model's area under the curve against: 1) 22 experts' predictions; and 2) preoperative prolapse reduction stress testing. A model containing seven predictors discriminated between de novo SUI status (concordance index 0.73, 95% confidence interval [CI] 0.65-0.80) in Outcomes Following Vaginal Prolapse Repair and Midurethral Sling participants and outperformed expert clinicians (area under the curve 0.72 compared with 0.62, P<.001) and preoperative urinary stress testing (area under the curve 0.72 compared with 0.54, P<.001). The concordance index for Colpopexy and Urinary Reduction Efforts trial participants was 0.62 (95% CI 0.56-0.69). This individualized prediction model for de novo SUI after vaginal POP surgery is valid and outperforms preoperative stress testing, prediction by experts, and preoperative reduction cough stress testing. An online calculator is provided for clinical use. : III.
    No preview · Article · Feb 2014 · Obstetrics and Gynecology
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    ABSTRACT: To develop a valid laparoscopic sacrocolpopexy simulation model for use as an assessment and learning tool for performing this procedure. A training model was developed to simulate performing a laparoscopic sacrocolpopexy. Construct validity was measured by comparing observed masked performances on the model between experienced Female Pelvic Medicine and Reconstructive Surgeons, 'Experts,' and upper level trainees, 'Trainees,' at two tertiary academic centers. All video-taped performances were scored by two surgeons who were masked to subject's identity utilizing the valid and reliable Global Operative Assessment of Laparoscopic Skills (GOALS) scale. The 'Expert' group included Female Pelvic Medicine and Reconstructive Surgeons (N=5) experienced with laparoscopic sacrocolpopexy and the 'Trainee' group (N=15) included fourth year gynecology residents (N=5) and fellows in Female Pelvic Medicine and Reconstructive Surgery and Minimally Invasive Gynecologic Surgery (N=10). 'Experts' performed significantly better than 'Trainees' in the total score and in every domain of the GOALS scale ('Expert' group median = 33 [30.5-39] vs. 20.5 [range 13.5-30.5], p=0.002). Previous surgical experience had a strong association with performance on the model (Rho > 0.75). The majority of subjects 'agreed' or 'strongly agreed' that the model was authentic to the live procedure and a useful training tool. There was strong agreement between masked raters (Interclass Correlation Coefficient 0.84). This simulation model is valid and reliable for assessing performance of laparoscopic sacrocolpopexy and may be used for practicing key steps of this procedure.
    No preview · Article · Jan 2014 · Journal of Minimally Invasive Gynecology

Publication Stats

2k Citations
273.85 Total Impact Points

Institutions

  • 2008-2014
    • Cleveland Clinic
      • • Women's Health Institute
      • • Department of Gynecology and Obstetrics
      Cleveland, Ohio, United States
    • Women’s Health Institute of Illinois
      Oak Lawn, Illinois, United States
  • 2012
    • Duke University Medical Center
      Durham, North Carolina, United States
    • University of North Dakota
      • Department of Educational Foundations and Research
      Grand Forks, North Dakota, United States