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.

Rectocele: Correlation Between Defecography and Physical Examination.

IMPORTANCE: There is a lack of consensus regarding the clinical applicability of fluoroscopic defecography in evaluation of pelvic organ prolapse. OBJECTIVES: The aim was to evaluate the association between rectocele on defecography and posterior vaginal wall prolapse (PVWP) on physical examination. The secondary objective was to describe radiologic and clinical predictors of surgical intervention and outcomes. STUDY DESIGN: This was a retrospective review of patients enrolled in a large health maintenance organization who underwent defecography and were examined by a urogynecologist within 12 months. The electronic medical record was reviewed for demographic and clinical variables, including pelvic organ prolapse and defecatory symptoms, physical examination, and surgical intervention through 12 months after initial urogynecologic examination or 12 months after surgery if applicable. RESULTS: One hundred eighty-six patients met inclusion criteria. Of those, 168 (90.3%) had a rectocele on defecography and 31 (16.6%) had PVWP at or beyond the hymen. Rectocele size on defecography was poorly correlated with PVWP stage (spearman ρ = 0.18). Forty patients underwent surgical intervention. Symptoms of splinting, digitation, and stool trapping were associated with surgical intervention (odds ratio, 4.24; 95% confidence interval, 1.59-11.34; P < 0.01) as was advanced PVWP stage ( P < 0.01), while rectocele presence and size on defecography were not. Large rectocele size on defecography was correlated with persistent postoperative defecatory symptoms ( P = 0.02). CONCLUSIONS: We demonstrated a poor correlation between rectocele size on defecography and PVWP stage. Defecatory symptoms (splinting, digitation, stool trapping) and higher PVWP stage were associated with surgical intervention, while rectocele on defecography was not.

A Randomized Controlled Trial Evaluating the Effect of an Educational Video on Patient Understanding of Midurethral Sling.

OBJECTIVE: The primary objective was to evaluate the use of a novel video for enhancing patient knowledge of midurethral sling compared with standard handout. METHODS: Participants scheduled for midurethral sling were randomized to 1 of 2 preoperative educational interventions, either video or standard handout. The primary outcome was change in knowledge measured via a 15-question questionnaire completed immediately before and after the intervention. Secondary outcomes were knowledge retention, urinary symptoms, decision satisfaction, and regret measured via validated questionnaires at 2 and 6 weeks postoperatively. Data are presented as median (interquartile range) and comparisons between intervention groups made using non-parametric statistics. A sample size of 16 per arm was calculated to detect a 20% effect size. RESULTS: Thirty-eight participants, 19 per site, were randomized from August 2019 to October 2020 and 37 (97%) completed the primary outcome per protocol. Median age was 51 years (18 years), and there were no significant demographic differences between groups. Participants randomized to video demonstrated greater change in knowledge than those randomized to handout (+8.5 (3) vs +2.0 (4), P < 0.0001). Those randomized to video demonstrated improved 6 week postoperative urinary symptoms (Urogenital Distress Inventory-6, 0.0 [8.3] vs 14.6 [26.0]; P = 0.02; Incontinence Severity Index, 0.0 [2] vs 3.0 [4]; P = 0.005). There were no differences in satisfaction with decision (5.0 [0] video vs 5.0 [0.9] handout; P = 0.48) or decision regret (1.0 [0.5] video vs 1.0 [0.8] handout; P = 0.80) at 6 weeks postoperatively. CONCLUSIONS: A preoperative educational video improved knowledge and urinary symptoms after midurethral sling compared with a standard handout.

Vulvovaginal involvement in Stevens-Johnson syndrome and toxic epidermal necrolysis: management and techniques used to reduce gynecologic sequelae.

BACKGROUND: Vulvovaginal involvement in Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) is common, likely underdiagnosed, and can result in severe sequelae if not managed acutely. There are few studies on acute management of vulvovaginal SJS/TEN. Current recommendations are predominantly based on expert opinion. We aimed to determine the frequency of vulvovaginal involvement in SJS/TEN at a single institution, identify treatment modalities, and assess outcomes at a tertiary care burn center. METHODS: This is a retrospective review of vulvovaginal SJS/TEN cases between 2009 and 2019. Demographic and clinical data including exam findings, treatment regimens, and outpatient follow-up were collected from the electronic medical record. RESULTS: Vulvovaginal involvement was observed in 12.7% (19/149) of cases of female patients with SJS/TEN. The mean age was 38.7 years (SD 23.6), and 21% (4/19) of patients were pediatric (age 9-18). Vulvar involvement was seen in 47.3% (9/19), and vulvar plus vaginal involvement was reported in 42.1% (8/19). Treatment regimens were variable until 2017, at which time institutional guidelines were implemented including application of ultrapotent topical steroid, vaginal estrogen, and menstrual suppression. Gynecology follow-up occurred in 15.7% (3/19) of cases. One complication of superficial vaginal agglutination was noted and was successfully treated in the office with blunt dissection. CONCLUSION: The most common treatment modalities employed at our institution included application of ultrapotent topical steroid, vaginal estrogen, and menstrual suppression. While follow-up was limited for our patient population, we propose an algorithm to prevent long-term sequalae of vulvovaginal SJS/TEN. Gynecologic surveillance is recommended to reduce urogynecologic sequelae.

Fecal Putative Uropathogen Abundance and Antibiotic Resistance Gene Carriage in Women With Refractory Recurrent Urinary Tract Infection Treated With Fecal Microbiota Transplantation.

OBJECTIVE: The aims of this study were to describe the fecal relative abundance of potentially uropathogenic bacteria and to analyze antibiotic resistance genes before and after fecal microbiota transplantation in women with recurrent urinary tract infection (UTI). METHODS: Shotgun sequencing was performed on fecal samples from 3 donors and 4 women with recurrent UTI who underwent transplantation. Recipient samples were sequenced at baseline and at 4 time points through 6 months postintervention. Relative fecal uropathogen abundance was analyzed by species and participant using descriptive statistics. Antibiotic resistance gene abundance was assigned, normalized, and compared between donors and recipients at baseline and postintervention using an abundance bar plot, nonmetric multidimensional scaling, and pairwise permutational multivariate analysis of variance. RESULTS: The median (range) relative abundance of Escherichia coli in all fecal samples from women with recurrent UTI was 0% (0%-5.10%); Enterococcus faecalis, 0% (0%-0.20%); Enterococcus faecium, 0% (0%-1.90%); Klebsiella pneumoniae, 0% (0%-0.10%); and Pseudomonas aeruginosa, 0% (0%-0.10%). Gut microbes carried genes conferring resistance to antibiotics used for UTI. No significant difference was seen in antibiotic resistance gene carriage after transplantation compared with baseline (P=0.22, R2=0.08 at 3 months). Antibiotic gene composition and abundance were significantly associated with the individual from whom the sample came (P=0.004, R2=0.78 at 3 months). CONCLUSIONS: Exploratory analysis of gut microbiomes in women with recurrent UTI identifies no or low relative putative uropathogen abundance for all species examined. Antibiotic resistance gene carriage persisted after fecal microbiota transplantation, although conclusions are limited by small sample size.

Bowel Obstruction After Sacrocolpopexy: A Case Series.

OBJECTIVES: Bowel obstruction after sacrocolpopexy (SC) can cause significant morbidity. The aim of this study was to delineate clinical and surgical factors associated with bowel obstruction after SC and to describe its presentation, management, and sequelae. METHODS: We performed a retrospective case series of patients who underwent open, laparoscopic, or robotic SC within a large health maintenance organization and a single academic medical center between January 1, 2009, and December 31, 2019. RESULTS: Of 3,231 patients who underwent SC, 32 (1.0%) experienced a bowel obstruction. Sacrocolpopexy was performed laparoscopically or robotically in 19 (59.4%) and abdominally in 13 (40.6%). The mean time to bowel obstruction was 1.9 years (SD, 2.5; range, 3 days to 8.8 years). In patients who experienced bowel obstruction, medical management was undertaken in 19 (61.3%) cases. Eight of the 13 (61.5%) surgically managed cases underwent bowel resection, and 3 cases (23.1%) reported partial mesh excision. Recurrent obstruction was seen in 2 (10.5%) of the medically managed and 2 (15.4%) of the surgically managed cases. CONCLUSIONS: Bowel obstruction is a rare complication of SC and our rate of at least 1.0% corroborates those in the literature. Obstruction occurs from days to years after SC. Nonsurgical management was effective in most cases, with low rates of recurrent obstruction. In surgically managed cases, the majority included bowel resection or mesh excision; however, mesh excision was not associated with a subsequent identifiable procedural intervention for recurrent prolapse. These data inform patient counseling and surgical planning before SC and aid in diagnosis and management of bowel obstruction after SC.

Rethinking Second-Line Therapy for Overactive Bladder to Improve Patient Access to Treatment Options.

Idiopathic overactive bladder (OAB) is a chronic condition that negatively affects quality of life, and oral medications are an important component of the OAB treatment algorithm. Recent literature has shown that anticholinergics, the most commonly prescribed oral medication for the treatment of OAB, are associated with cognitive side effects including dementia. ß3-adrenoceptor agonists, the only alternative oral treatment for OAB, are similar in efficacy to anticholinergics with a more favorable side effect profile without the same cognitive effects. However, there are marked cost variations and barriers to access for OAB medications, resulting in expensive copays and medication trial requirements that ultimately limit access to ß3-adrenoceptor agonists and more advanced procedural therapies. This contributes to and perpetuates health care inequality by burdening the patients with the least resources with a greater risk of dementia. When prescribing these medications, health care professionals are caught in a delicate balancing act between cost and patient safety. Through multilevel collaboration, we can help disrupt health care inequalities and provide better care for patients with OAB.