Patient perspectives in adverse event reporting after vaginal apical prolapse surgery.

BACKGROUND: Many clinical trials use systematic methodology to monitor adverse events and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspectives are often not included in this process. OBJECTIVE: This study aimed to compare clinician vs patient grading of adverse event severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association of patient grading of adverse events with decision-making and quality of life outcomes and to determine if patient perspective changes over time. STUDY DESIGN: This was a planned supplementary study (Patient Perspectives in Adverse Event Reporting [PPAR]) to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, adverse events experienced by patients were collected per a standardized protocol every 6 months during which clinicians graded adverse event severity (mild, moderate, severe/life-threatening). In this substudy, we obtained additional longitudinal patient perspectives for 19 predetermined "PPAR adverse events." Patients provided their own severity grading (mild, moderate, severe/very severe/life-threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other's reporting. The primary outcome was the interrater agreement (kappa statistic) for adverse event severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. The association between adverse event severity and the Decision Regret Scale, Satisfaction with Decision Scale, the 12-Item Short-Form Health Survey, and Patient Global Impression of Improvement scores was assessed using the Spearman correlation coefficient (ρ) for continuous scales, the Mantel-Haenszel chi-square test for Patient Global Impression of Improvement, and t tests or chi-square tests comparing the assessments of patients who rated their adverse events or symptoms as severe with those who gave other ratings. To describe patient perspective changes over time, the intraobserver agreement was estimated for adverse event severity grade over time using weighted kappa coefficients. RESULTS: Of the 360 randomly assigned patients, 219 (61%) experienced a total of 527 PPAR adverse events (91% moderate and 9% severe/life-threatening by clinician grading). Mean patient age was 67 years; 87% were White and 12% Hispanic. Among the patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%). Overall agreement between clinician and participant grading of severity was poor (kappa=0.24 [95% confidence interval, 0.14-0.34]). Of the 414 adverse events that clinicians graded as moderate, patients graded 120 (29%) as mild and 80 (19%) as severe. Of the 39 adverse events graded as severe by clinicians, patients graded 15 (38%) as mild or moderate. Initial patient grading of the most severe reported adverse event was mildly correlated with worse Decision Regret Scale (ρ=0.2; P=.01), 12-Item Short-Form Health Survey (ρ=-0.24; P<.01), and Patient Global Impression of Improvement (P<.01) scores. There was no association between adverse event severity and Satisfaction with Decision Scale score. Patients with an initial grading of "severe" had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (P<.05). Agreement between the patients' initial severity ratings and their ratings at 12 months (kappa=0.48 [95% confidence interval, 0.39-0.58]) and 36 months (kappa=0.45 [95% confidence interval, 0.37-0.53]) was fair. CONCLUSION: Clinician and patient perceptions of adverse event severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.

Long-term pelvic organ prolapse recurrence and mesh exposure following sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: Large, long-term studies are needed to compare pelvic organ prolapse (POP) recurrence and mesh exposure following all modes of sacrocolpopexy (open, robotic, and laparoscopic). We hypothesized that the prevalence of recurrent POP and mesh exposure does not differ between modes of sacrocolpopexy. METHODS: This is a retrospective cohort study with a cross-sectional, prospective survey. Participants were surveyed regarding complications, retreatments, and symptoms following sacrocolpopexy. Baseline characteristics, POP recurrence, mesh exposure, and survey responses were compared. RESULTS: A total of 709 participants met the criteria. Median time from sacrocolpopexy to last follow-up for all participants was 0.5 years (2 days to 13.4 years). 15.0% experienced recurrent stage 2 or greater POP or underwent retreatment (open 11.7% [95% CI 7.8-17.2%]; robotic 21.1% [95% CI 15.6-27.9%]; laparoscopic 13.8% [95% CI 10.6-17.9%]; p = 0.03). After adjusting for baseline differences there was no significant difference among groups (p = 0.30). 5.3% experienced mesh and/or suture exposure (mesh n = 19, suture n = 10, mesh and suture n = 8) with no significant difference among groups (open 7.7% [95% CI 4.6-12.5%]; robotic 3.6% [95% CI 1.7-7.6%]; laparoscopic 4.9% [95% CI 3.1-7.7%]; p = 0.20). Median time from sacrocolpopexy to survey completion was 6.5 (1.6-13.4) years. 9.2% reported evaluation or treatment for recurrent POP (open 6.3% [95% CI 2.1-16.8%]; robotic 12.5% [95% CI 6.9-21.5%]; laparoscopic 8.5% [5.1-13.8%]; p = 0.44). 6.9% reported evaluation or treatment for mesh exposure (open 6.0% [95% CI 2.1-16.2%]; robotic 3.9% [95% CI 1.3-10.7%]; laparoscopic 8.6% [5.2-13.9%]; p = 0.38). CONCLUSIONS: Objective and patient-reported long-term prevalence of POP recurrence and mesh exposure are low following all modes of sacrocolpopexy.

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.

Reliability and agreement of urodynamics interpretations in a female pelvic medicine center.

OBJECTIVE: To estimate the reliability and interobserver consistency of urodynamic interpretations of female bladder and urethral function. METHODS: Three urogynecologists and three female urologists at a tertiary care medical center reviewed masked, abstracted clinical and urodynamic information from 100 charts, selected for adequate completeness from a consecutive series of 135 women referred for urodynamic testing. For each of the 100 cases, the reviewers assigned International Continence Society filling and voiding phase diagnoses, and overall clinical diagnoses. Raw agreement proportions and weighted kappa chance-corrected agreement statistics (kappa) were used jointly to describe both reliability and interobserver agreement. Reliability was estimated from duplicate reviews, masked and separated by at least 4 months, of each case by each physician. Interobserver agreement was estimated from comparisons of all pairs of responses from different physicians. RESULTS: For clinical diagnosis of stress incontinence (present, absent, indeterminate), the within- and across-physician weighted kappa's were, respectively, 0.78 and 0.68. Corresponding results were 0.40 and 0.13 for detrusor overactivity without incontinence, 0.58 and 0.38 for detrusor overactivity with incontinence, and 0.51 and 0.26 for voiding dysfunction. Standard errors of each kappa were between 0.023 and 0.043. CONCLUSION: In our group, lower urinary tract diagnoses of stress urinary incontinence from both clinical and urodynamic data demonstrated substantial reliability and interobserver agreement. However, by conventional interpretation of kappa-statistics, reliability of diagnoses of detrusor overactivity or voiding dysfunction was only moderate, and interobserver agreement on these diagnoses was no better than fair. Urodynamic interpretations may not be satisfactorily reproducible for these diagnoses.

Quality of life after surgery for genital prolapse in elderly women: obliterative and reconstructive surgery.

The objective of this study was to determine if obliterative and reconstructive vaginal surgery for advanced pelvic organ prolapse improve quality of life in elderly women. Women age 65 years or older with stage 3 or 4 pelvic organ prolapse who desired surgical correction were prospectively enrolled. The subjects underwent either obliterative or reconstructive vaginal surgery based on their personal preference and sexual expectations. The subjects received a pelvic organ prolapse quantitation examination and completed the pelvic floor distress inventory (PFDI), the pelvic floor impact questionnaire (PFIQ), the SF-36, and the Beck depression inventory preoperatively, 6 and 12 months after surgery. Seventy-nine subjects were enrolled, 70 of whom completed follow-up: 30 in the obliterative group and 40 in the reconstructive group. Both groups demonstrated significant improvements in the pelvic organ prolapse, urinary, and colorectal scales of the PFDI and PFIQ 6 and 12 months after surgery with no differences between the two treatment groups. In addition, there were significant and clinically important improvements noted in the bodily pain, vitality, social functioning, role-emotional, and mental health summary scales of the SF-36 in both groups after surgery, with no significant difference between groups. In appropriately selected elderly women, both obliterative and reconstructive vaginal surgery for advanced pelvic organ prolapse significantly improved health-related quality of life.

Laparoscopic management of ureteric obstruction after uterosacral vaginal vault suspension.

The uterosacral ligaments commonly are used to correct pelvic organ prolapse. For experienced surgeons, the rate of ureteral injury with uterosacral vaginal vault suspensions is 2%-4%. Exploratory laparotomy and ureterolysis has been used to treat iatrogenic ureteral injury. A 64-year-old woman with stage III pelvic organ prolapse underwent surgical correction with an uterosacral vaginal vault suspension. On postoperative day 1, the patient was diagnosed with partial ureteral obstruction. She underwent laparoscopic ureterolysis and stent placement. A follow-up intravenous pyelogram showed no evidence of damage or obstruction. With proper patient selection, ureteral obstruction after vault suspension procedures can be managed with laparoscopic ureterolysis, avoiding the morbidity associated with laparotomy.

Clinical evaluation of anterior vaginal wall support defects: interexaminer and intraexaminer reliability.

OBJECTIVE: The purpose of this study was to determine the interobserver and intraobserver reliability of the clinical examination of anterior vaginal wall support defects. STUDY DESIGN: Sixty-three patients with at least stage II anterior vaginal wall prolapse were prospectively evaluated with a standardized examination to detect anterior vaginal wall support defects. Interobserver reliability was assessed with a duplicate examination performed by a blinded second examiner. Intraobserver reliability was assessed with a second examination performed at least 3 weeks later by 1 of the original 2 examiners. Examination reliability for the 4 types of defects (central, right lateral, left lateral, and superior) was evaluated with the kappa statistic. RESULTS: The inter- and intraexaminer reliability of the clinical examination for central, superior, and right and left paravaginal defects was poor; all kappas were less than 0.50. Overall interexaminer agreement was 42% with a kappa of 0.16 (95% CI, 0-0.32). Overall intraexaminer agreement was 46% with a kappa of 0.16 (95% CI, 0-0.45). Reliability was noted to improve with increasing stage of prolapse. CONCLUSION: The clinical examination of anterior vaginal wall support defects displays poor interexaminer and intraexaminer agreement.