Responsiveness and minimally important difference of SF-6D and EQ-5D utility scores for the treatment of pelvic organ prolapse.

BACKGROUND: Utility preference scores are standardized, generic, health-related quality of life (HRQOL) measures that quantify disease severity and burden and summarize morbidity on a scale from 0 (death) to 1 (optimal health). Utility scores are widely used to measure HRQOL and in cost-effectiveness research. OBJECTIVE: To determine the responsiveness, validity properties, and minimal important difference (MID) of utility scores, as measured by the Short Form 6D (SF-6D) and EuroQol (EQ-5D), in women undergoing surgery for pelvic organ prolapse (POP). MATERIALS AND METHODS: This study combined data from 4 large, U.S., multicenter surgical trials enrolling 1321 women with pelvic organ prolapse. We collected condition-specific quality of life data using the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). A subset of women completed the SF6D; women in 2 trials also completed the EQ5D. Mean utility scores were compared from baseline to 12 months after surgery. Responsiveness was assessed using effect size (ES) and standardized response mean (SRM). Validity properties were assessed by (1) comparing changes in utility scores at 12 months between surgical successes and failures as defined in each study, and (2) correlating changes in utility scores with changes in the PFDI and PFIQ. MID was estimated using both anchor-based (SF-36 general health global rating scale "somewhat better" vs "no change") and distribution-based methods. RESULTS: The mean SF-6D score improved 0.050, from 0.705 ± 0.126 at baseline to 0.761 ± 0.131 at 12 months (P < .01). The mean EQ-5D score improved 0.060, from 0.810 ± 0.15 at baseline to 0.868 ± 0.15 at 12 months (P < .01). The ES (0.13-0.61) and SRM (0.13-0.57) were in the small-to-moderate range, demonstrating the responsiveness of the SF-6D and EQ-5D similar to other conditions. SF-6D and EQ-5D scores improved more for prolapse reconstructive surgical successes than for failures. The SF-6D and EQ-5D scores correlated with each other (r = 0.41; n = 645) and with condition-specific instruments. Correlations with the PFDI and PFIQ and their prolapse subscales were in the low to moderate range (r = 0.09-0.38), similar to other studies. Using the anchor-based method, the MID was 0.026 for SF-6D and 0.025 for EQ-5D, within the range of MIDs reported in other populations and for other conditions. These findings were supported by distribution-based estimates. CONCLUSION: The SF-6D and EQ-5D have good validity properties and are responsive, preference-based, utility and general HRQOL measures for women undergoing surgical treatment for prolapse. The MIDs for SF-6D and EQ-5D are similar and within the range found for other medical conditions.

Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women.

OBJECTIVE: The objective of this study was to compare the backfill standard voiding trial (SVT) that relies on the assessment of voided volume to subjective patients' evaluation of their voiding based on the assessment of the force of stream (FOS) after an outpatient midurethral sling surgery. STUDY DESIGN: This double-blinded randomized trial included patients undergoing an outpatient midurethral sling surgery without any other concomitant surgery. Participants were randomized to either the SVT group or to the FOS group. The primary outcome was the rate of catheterization any time up to 6 weeks after surgery. Both groups underwent the same backfill voiding trial protocol postoperatively. Measurements of the voided amount, postvoid residual, and the response to the FOS visual analog scale were collected. The criteria for passing the voiding trial in the SVT group was voiding at least two-thirds of the instilled amount; while the criteria for passing the trial in the FOS group was assessment of FOS at least 50% of the baseline, regardless of the voided volume. Participants were interviewed preoperatively and 2-4 days, 7-9 days, and 6 weeks postoperatively. All postoperative interviews included assessments of pain, tolerance of physical activity, urinary FOS, as well as satisfaction with the surgery. Validated questionnaires (Incontinence Severity Index and Urinary Distress Inventory, short form) before the surgery and 6 weeks after were used to evaluate urinary symptoms. RESULTS: A total of 108 patients were enrolled and randomized, and 6-week follow-up data were available for 102 participants (FOS 50, SVT 52). The 2 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=.95). Amount voided had a moderate correlation with FOS assessment (Spearman rho 0.5; P<.001). There was no significant difference in mean catheter days, pain scores, Incontinence Severity Index, and Urinary Distress Inventory, short form scores between the 2 groups. Of the patients who were discharged home without a catheter in either group none required catheter reinsertion within 6 weeks after the surgery. CONCLUSION: Patient's subjective assessment of the urinary FOS 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 FOS is a reliable and safe method to use after outpatient midurethral surgery.

Development and validation of a laparoscopic sacrocolpopexy simulation model for surgical training.

STUDY OBJECTIVE: To develop a valid laparoscopic sacrocolpopexy simulation model for use as an assessment and learning tool for performing this procedure. DESIGN: Simulation study (Canadian Task Force classification II-2). SETTING: Two tertiary academic centers. INTERVENTION: A training model was developed to simulate performance of 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. All videotaped performances were scored by 2 surgeons who were masked to subject identity and using the valid and reliable Global Operative Assessment of Laparoscopic Skills scale. MEASUREMENTS AND MAIN RESULTS: The expert group included Female Pelvic Medicine and Reconstructive Surgeons (n = 5) experienced in 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 in Minimally Invasive Gynecologic Surgery (n = 10). The experts performed significantly better than the trainees in total score and in every domain of the Global Operative Assessment of Laparoscopic Skills scale (median [range] score: expert group, 33 [30.5-39] vs. trainee group, 20.5 [13.5-30.5]; p = .002). Previous surgical experience had a strong association with performance on the model (rho > 0.75). Most 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). CONCLUSION: This simulation model is valid and reliable for assessing performance of laparoscopic sacrocolpopexy and may be used for practicing key steps of the procedure.

Epidemiology and outcome assessment of pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The aim was to determine the incidence and prevalence of pelvic organ prolapse surgery and describe how outcomes are reported. METHODS: Every 4 years and as part of the Fifth International Collaboration on Incontinence we reviewed the English-language scientific literature after searching PubMed, Medline, Cochrane library and Cochrane database of systematic reviews, published up to January 2012. Publications were classified as level 1 evidence (randomised controlled trials [RCT] or systematic reviews, level 2 (poor quality RCT, prospective cohort studies), level 3 (case series or retrospective studies) and level 4 (case reports). The highest level of evidence was utilised by the committee to make evidence-based recommendations based upon the Oxford grading system. A grade A recommendation usually depends on consistent level 1 evidence. A grade B recommendation usually depends on consistent level 2 and/or 3 studies, or "majority evidence" from RCTs. A grade C recommendation usually depends on level 4 studies or "majority evidence" from level 2/3 studies or Delphi processed expert opinion. A grade D "no recommendation possible" would be used where the evidence is inadequate or conflicting and when expert opinion is delivered without a formal analytical process, such as by Delphi . RESULTS: Pelvic organ prolapse (POP) when defined by symptoms has a prevalence of 3-6% and up to 50% when based upon vaginal examination. Surgery for prolapse is performed twice as commonly as continence surgery and prevalence varies widely from 6 to 18%. The incidence of POP surgery ranges from 1.5 to 1.8 per 1,000 women years and peaks in women aged 60-69. When reporting outcomes of the surgical management of prolapse, authors should include a variety of standardised anatomical and functional outcomes. Anatomical outcomes reported should include all POP-Q points and staging, utilising a traditional definition of success with the hymen as the threshold for success. Assessment should be prospective and assessors blinded as to the surgical intervention performed if possible and without any conflict of interest related to the assessment undertaken (grade C). Subjective success postoperatively should be defined as the absence of a vaginal bulge (grade C). Functional outcomes are best reported using valid, reliable and responsive symptom questionnaires and condition-specific HRQOL instruments (grade C). Sexual function is best reported utilising validated condition-specific HRQOL that assess sexual function or validated sexual function questionnaires such as the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ) or the Female Sexual Function Index (FSFI). The sexual activity status of all study participants should be reported pre- and postoperatively under the following categories: sexually active without pain, sexually active with pain or not sexually active (grade C). Prolapse surgery should be defined as primary surgery, and repeat surgery sub-classified as primary surgery different site, repeat surgery, complications related to surgery and surgery for non-prolapse-related conditions (grade C). CONCLUSION: Significant variation exists in the prevalence and incidence of pelvic organ prolapse surgery and how the outcomes are reported. Much of the variation may be improved by standardisation of definitions and outcomes of reporting on pelvic organ prolapse surgery.

Utility of postoperative laboratory studies after female pelvic reconstructive surgery.

OBJECTIVE: We sought to determine the frequency of laboratory studies after female pelvic reconstructive surgery and the rate of intervention based on the results of these laboratory values at a single institution. STUDY DESIGN: We conducted a retrospective review of all patients undergoing female pelvic reconstructive surgery for pelvic organ prolapse by 5 fellowship-trained pelvic reconstructive surgeons at a single institution from Jan. 1, 2010, through Dec. 31, 2010. Exclusion criteria were outpatient procedures, isolated hysterectomy, and a combined surgery with another surgical team performing a separate procedure. Interventions based on the number of laboratory studies were classified as minor (electrolyte repletion, repeat laboratory tests, initiation of antibiotics) or major (transfusion, delayed discharge). RESULTS: A total of 356 patients were included in the final dataset and 100% of patients had routine postoperative laboratory studies. A total of 8771 laboratory values were obtained with a mean of 25 ± 18 laboratory values (0-133) per patient. One-third of postoperative patients (n = 120) underwent a total of 207 interventions based on abnormal laboratory results. The majority of interventions were minor (96%). Of the 120 patients who had a minor intervention, electrolyte repletion was the most common (78%), followed by repeat blood collection (40%) and initiation of antibiotics (4%). The major intervention rate was 4% (n = 8) and all underwent transfusion. Of the 8 transfused patients, 7 demonstrated clinical instability before transfusion and 1 was transfused based on laboratory values and a significant cardiac history. CONCLUSION: Routine postoperative laboratory studies are not necessary for all patients after female pelvic reconstructive surgery and more judicious use based on clinical findings may limit unnecessary minor interventions.

Validation of the activities assessment scale in women undergoing pelvic reconstructive surgery.

OBJECTIVE: The Activities Assessment Scale (AAS) is a 13-item postoperative functional activity scale validated in men who underwent hernia surgery. We evaluated the psychometric characteristics of the AAS in women who underwent vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). METHODS: Participants included 163 women with POP and SUI enrolled in a randomized trial comparing sacrospinous ligament fixation to uterosacral vault suspension with and without perioperative pelvic floor muscle training. Participants completed the AAS and SF-36 at baseline and 2 weeks and 6 months postoperatively. Internal reliability of the AAS was evaluated using Cronbach α. Construct validity and responsiveness were examined in cross-sectional and longitudinal data using Pearson correlation coefficient and analysis of variance. The AAS is scored from zero to 100 (higher scores=better function). RESULTS: Mean (SD) baseline AAS score was 87 (17.3) (range, 25-100). Functional activity declined from baseline to 2 weeks postoperatively (mean change, -4.5; 95% confidence interval, -7.6 to -1.42) but improved above baseline at 6 months (mean change, +10.9; 95% confidence interval, 7.8-14.0). Internal reliability of the AAS was excellent (Cronbach α=0.93). Construct validity was demonstrated by a correlation of 0.59 to 0.60 between the AAS and SF-36 physical functioning scale (P<0.0001) and lower correlations between the AAS and other SF-36 scales. Patients who improved in physical functioning based on the SF-36 between 2 weeks and 6 months postoperatively showed an effect size of 0.86 for change in the AAS over the same period. CONCLUSIONS: The AAS is a valid, reliable, and responsive measure for evaluation of physical function in women after pelvic reconstructive surgery.

Nomogram to predict successful placement in surgical subspecialty fellowships using applicant characteristics.

PURPOSE: The purpose of the study was to develop a model that predicts an individual applicant's probability of successful placement into a surgical subspecialty fellowship program. METHODS: Candidates who applied to surgical fellowships during a 3-year period were identified in a set of databases that included the electronic application materials. RESULTS: Of the 1281 applicants who were available for analysis, 951 applicants (74%) successfully placed into a colon and rectal surgery, thoracic surgery, vascular surgery, or pediatric surgery fellowship. The optimal final prediction model, which was based on a logistic regression, included 14 variables. This model, with a c statistic of 0.74, allowed for the determination of a useful estimate of the probability of placement for an individual candidate. CONCLUSIONS: Of the factors that are available at the time of fellowship application, 14 were used to predict accurately the proportion of applicants who will successfully gain a fellowship position.

Assessment of four tissue models on knot tensile strength.

OBJECTIVE: To determine whether the tissue model onto which a knot is tied influences the knot's tensile strength. STUDY DESIGN: Zero-gauge, nonexpired, silk, polyglactin 910, polydioxanone, and polypropylene sutures were tied on 4 different mock tissue models. The tissue models were standard metal hex head screw, uncooked chicken breast, a tube of packaged "string" cheese, and a cylinder of bubble wrap. The knots were tied without a surgeon's knot and with 4 additional square knots (1 = 1 = 1 = 1 = 1). The knots were tied by a single obstetrician/gynecologist investigator (J.M.D.) over the period of 1 week to minimize fatigue. We compared the knots when subjected to a tensiometer until the suture broke or untied. A minimum of 20 knots per group were needed to detect a moderate effect size with a power of 85% and a type I error rate of 5%. RESULTS: A total of 407 knots were tied with 4 types of material (silk, polyglactin 910, polydioxanone, and polypropylene), using 4 different models (chicken, bubble wrap, cheese, and metal). Among the knot failures, 113 of 407 untied rather than broke (28%). No differences in the likelihood of knots coming untied between the different models (p = 0.34) or tension at failure (p = 0.81) were noted. A 4 × 4 factorial analysis of variance (ANOVA) was conducted to determine the effects of the suture material and model type on tension at failure and whether there was any interaction between the 2 factors. No significant difference was observed in the interaction between suture material and model type (p = 0.35), and no effect for model type was found (p = 0.22). CONCLUSIONS: Tissue models that use materials more similar to human tissue do not seem to influence knot strength when compared with standard metal models. We propose that it is possible to have an accurate understanding of how knots withstand force and to simulate an in vivo environment by using low-cost, easily accessible natural and synthetic materials for the mechanism onto which the knot is tied.

Factors used by program directors to select obstetrics and gynecology fellows.

OBJECTIVE: To describe the factors and attributes that obstetrics and gynecology fellowship directors use in selecting applicants for interview and ranking. METHODS: Anonymous questionnaires were completed by obstetrics and gynecology fellowship directors using a web-based survey (adapted from a previously published questionnaire) before match day 2011. Fellow selection practices were evaluated and included importance of prematch preparations, screening of applications, interview processes, and recommendations given to applicants. Fellowship directors were asked to grade selection factors based on a 5-point Likert-like scale (ranging from 1 being unimportant to 5 being essential). RESULTS: A total of 187 fellowship directors representing programs accredited by the American Board of Obstetrics and Gynecology, Inc. were surveyed, and 124 completed the survey (66% response rate). The factors in prematch preparations that 99-100% of program directors found in the essential to important range were a high-quality obstetrics and gynecology residency training program and experience with clinical research during residency or with clinical research after residency. Surgical experience was valued more by gynecologic oncologist respondents than by other subspecialty respondents, although this statistic did not reach statistical significance (P=.08). CONCLUSION: Education pedigree and research experience are important factors considered by fellowship directors when selecting fellowship applicants. For applicants, these data will allow for a critical self-analysis before applying or interviewing.

Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial.

OBJECTIVE: To compare conventional laparoscopic and robotic-assisted laparoscopic sacrocolpopexy for vaginal apex prolapse. METHODS: This single-center, blinded randomized trial included participants with stage 2-4 posthysterectomy vaginal prolapse. Participants were randomized to laparoscopic or robotic sacrocolpopexy. The primary outcome was total operative time from incision to closure. Secondary outcomes were postoperative pain, functional activity, bowel and bladder symptoms, quality of life, anatomic vaginal support, and cost from a health care system perspective. RESULTS: A total of 78 patients enrolled and were randomized (laparoscopic n=38; robotic n=40). Total operative time was significantly longer in the robotic group compared with the laparoscopic group (+67-minute difference; 95% confidence interval [CI] 43-89; P<.001). Anesthesia time, total time in the operating room, total sacrocolpopexy time, and total suturing time were all significantly longer in the robotic group. Participants in the robotic group also had significantly higher pain at rest and with activity during weeks 3 through 5 after surgery and required longer use of nonsteroidal anti-inflammatory drugs (median, 20 compared with 11 days, P<.005). The robotic group incurred greater cost than the laparoscopic group (mean difference +$1,936; 95% CI $417-$3,454; P=.008). Both groups demonstrated significant improvement in vaginal support and functional outcomes 1 year after surgery with no differences between groups. CONCLUSION: Robotic-assisted sacrocolpopexy results in longer operating time and increased pain and cost compared with the conventional laparoscopic approach.

Objective assessment of vaginal surgical skills.

OBJECTIVE: To develop and validate an instrument to assess surgical skills during vaginal surgery. STUDY DESIGN: Trainees from 2 institutions were directly assessed in the operating room by supervising surgeons while performing a vaginal hysterectomy using the new Vaginal Surgical Skills Index, global rating scale, and visual analogue scale. Trainees were assessed again by the same surgeons 4 weeks after the live surgery and by a blinded outside reviewer using a videotape of the case. Internal consistency, interrater and intrarater reliability, and construct validity were evaluated. RESULTS: Two hundred twelve evaluations were analyzed on 76 surgeries from 27 trainees. There was good internal consistency, interrater, and intrarater reliability. Vaginal Surgical Skills Index scores correlated with global rating score and visual analog scale scores. Increasing Vaginal Surgical Skills Index scores significantly correlated with year of training and surgical volume with an estimated increase in score of 0.3 per hysterectomy performed. CONCLUSION: The Vaginal Surgical Skills Index is a feasible, reliable, and valid instrument to assess vaginal surgical skills.

Assessment of intraoperative judgment during gynecologic surgery using the Script Concordance Test.

OBJECTIVE: We sought to develop a valid, reliable assessment of intraoperative judgment by residents during gynecologic surgery based on Script Concordance Theory. STUDY DESIGN: This was a multicenter prospective study involving 5 obstetrics and gynecology residency programs. Surgeons from each site generated case scenarios based on common gynecologic procedures. Construct validity was evaluated by correlating scores to training level, in-service examinations, and surgical skill and experience using a Global Rating Scale of Operative Performance and case volumes. RESULTS: A final test that included 42 case scenarios was administered to 75 residents. Internal consistency (Cronbach alpha = 0.73) and test-retest reliability (Lin correlation coefficient = 0.76) were good. There were significant differences between test scores and training levels (P = .002) and test scores correlated with in-service examination scores (r = 0.38; P = .001). There was no association between test scores and total number of cases or technical skills. CONCLUSION: The Script Concordance Test appears to be a reliable, valid assessment tool for intraoperative decision-making during gynecologic surgery.

Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: design and methods.

The primary aims of this trial are: 1) to compare surgical outcomes following sacrospinous ligament fixation to uterosacral vaginal vault suspension in women undergoing vaginal surgery for apical or uterine pelvic organ prolapse and stress urinary incontinence and 2) to examine the effects of a structured perioperative program consisting of behavioral techniques and pelvic floor muscle training compared to usual care. This trial is performed through the Pelvic Floor Disorders Network (PFDN), which is funded by National Institute of Child Health and Human Development. Subjects will be enrolled from hospitals associated with seven PFDN clinical centers across the United States. A centralized biostatistical coordinating center will oversee data collection and analysis. Two approaches will be investigated simultaneously using a 2x2 randomized factorial design: a surgical intervention (sacrospinous ligament fixation versus uterosacral vaginal vault suspension) and a perioperative behavioral intervention (behavioral and pelvic floor muscle training versus usual care). Surgeons have standardized essential components of each surgical procedure and have met specific standards of expertise. Providers of the behavioral intervention have undergone standardized training. Anatomic, functional, and health-related quality of life outcomes will be assessed using validated measures by researchers blinded to all randomization assignments. Cost-effectiveness analysis will be performed using prospectively collected data on health care costs and resource utilization. The primary surgical endpoint is a composite outcome defined by anatomic recurrence, recurrence of bothersome vaginal prolapse symptoms and/or retreatment and will be assessed 2 years after the index surgery. Endpoints for the behavioral intervention include both short-term (6-month) improvement in urinary symptoms and long-term (2-year) improvement in anatomic outcomes and prolapse symptoms. This article describes the rationale and design of this randomized trial, focusing on several key design features of potential interest to researchers in the field of female pelvic floor disorders and others conducting randomized surgical trials.

A prospective assessment of overactive bladder symptoms in a cohort of elderly women who underwent transvaginal surgery for advanced pelvic organ prolapse.

OBJECTIVE: The objective of this study was to evaluate the impact of transvaginal prolapse surgery on overactive bladder symptoms in elderly women. STUDY DESIGN: Women (> or = 65 years old) with stage III or IV prolapse who enrolled in a prospective study that compared vaginal reconstructive surgery (n = 39) to obliterative surgery (n = 26) and who underwent preoperative urodynamics are the subjects of this study. The women completed the Pelvic Floor Distress Inventory at baseline and again 6 months and 12 months after surgery. Postoperative changes in symptoms of urinary urgency, frequency, and urge urinary incontinence were assessed. The association between a baseline urodynamic diagnosis of detrusor overactivity and pre- and postoperative overactive bladder symptoms was also determined. RESULTS: Data were analyzed from 65 subjects with a mean age of 75.3 years (range, 65.5-87.0 years). Detrusor overactivity was documented in 25% of subjects. There was no difference in the proportion of baseline urge incontinence (P = .38), urinary frequency (P = .53), or urgency (P = .76) in comparing women with and without detrusor overactivity. Surgery resulted in a significant reduction of urgency and frequency symptoms 6 months after surgery and a similar significant reduction in urgency and urge incontinence at 1 year after surgery. Overall, a clinically and statistically significant improvement in the irritative subscale of the Pelvic Floor Distress Inventory was noted at 6 months (18.3%; P < .0001) and 12 months (17.6%; P < .0001) after surgery. In our cohort, performance of a mid urethral sling, a bladder neck sling, or a Kelly plication was not associated with a reduction in postoperative symptoms of urgency, frequency, or urge incontinence (P = .48). Likewise, there was no difference in postoperative symptom reduction (urgency, frequency, or urge incontinence) between women who received reconstructive surgery vs women who had obliterative surgery (P = .84). CONCLUSION: Vaginal surgery for stage III or IV pelvic organ prolapse significantly reduces overactive bladder symptoms in elderly women. In our cohort, symptom reduction was unrelated to the type of vaginal surgery (obliterative vs reconstructive) or the inclusion of a procedure to treat stress incontinence. Furthermore, preoperative urodynamic findings did not correlate with the presence or absence of overactive bladder symptoms.