Projecting future prolapse outcomes with induction of labor at 39 weeks: a decision analysis.

INTRODUCTION AND HYPOTHESIS: In 2018, the ARRIVE trial (A Randomized Trial of Induction Versus Expectant Management) concluded that routine induction of labor (IOL) at 39 weeks gestation decreases cesarean delivery risk, with slightly lighter birthweight infants. We debated whether routine IOL would improve, worsen, or not change POP risk compared with expectant management (EM). METHODS: We constructed a decision analysis model with a lifetime horizon where nulliparous women reaching 39 weeks underwent IOL or EM. Subsequent vaginal versus cesarean delivery varied based on prior deliveries for up to four births. Subsequent delivery prior to 39 weeks and distribution of gestational age, birthweight, and delivery mode between 24 and 39 weeks was modeled from national data. We modeled increased POP risk with increasing vaginal parity, forceps delivery, and weight of largest infant delivered vaginally, accounting for differential infant weights in each strategy. RESULTS: IOL and EM have similar population-wide POP risk (15.9% and 15.7% respectively). Among women with only spontaneous vaginal deliveries that reached 39 weeks or beyond, the prevalence of POP was 20% after one delivery and 29% after four deliveries, with no difference between groups. The cesarean rate was lower with IOL (27.8% versus 29.8%). Sensitivity analysis revealed no meaningful thresholds among the variables, supporting model robustness. CONCLUSION: While routine induction of labor at 39 weeks results in a meaningfully higher vaginal delivery rate, there was no increase in POP, possibly due to the protective effect of lower birthweight.

Long-Term Costs of Minimally Invasive Sacral Colpopexy Compared to Native Tissue Vaginal Repair With Concomitant Hysterectomy.

STUDY OBJECTIVE: To determine the long-term costs of hysterectomy with minimally invasive sacrocolpopexy (MISCP) versus uterosacral ligament suspension (USLS) for primary uterovaginal prolapse repair. DESIGN: A hospital-based decision analysis model was built using TreeAge Pro (TreeAge Software Inc, Williamstown, MA). Those with prolapse were modeled to undergo either vaginal hysterectomy with USLS or minimally invasive total hysterectomy with sacrocolpopexy (MISCP). We modeled the chance of complications of the index procedure, prolapse recurrence with the option for surgical retreatment, complications of the salvage procedure, and possible second prolapse recurrence. The primary outcome was cost of the surgical strategy. The proportion of patients living with prolapse after treatment was the secondary outcome. SETTING: Tertiary center for urogynecology. PATIENTS: Female patients undergoing surgical repair by the same team for primary uterovaginal prolapse. INTERVENTIONS: Comparison analysis of estimated long-term costs was performed. MEASUREMENTS AND MAIN RESULTS: Our primary outcome showed that a strategy of undergoing MISCP as the primary index procedure cost $19 935 and that undergoing USLS as the primary index procedure cost $15 457, a difference of $4478. Furthermore, 21.1% of women in the USLS group will be living with recurrent prolapse compared to 6.2% of MISCP patients. Switching from USLS to MISCP to minimize recurrence risk would cost $30 054 per case of prolapse prevented. Additionally, a surgeon would have to perform 6.7 cases by MISCP instead of USLS in order to prevent 1 patient from having recurrent prolapse. CONCLUSION: The higher initial costs of MISCP compared to USLS persist in the long term after factoring in recurrence and complication rates, though more patients who undergo USLS live with prolapse recurrence.

Characterization of the GU microbiome in women with self-perceived bladder health over the life course.

BACKGROUND: A variety of factors influence bladder health, including environmental factors, life experiences, biologic foundations, and coexistent medical conditions. A biologically diverse microbial community exists in the urine that is likely influenced by the microbial inhabitants of the vagina. The relationship between the genitourinary (GU) microbiome and self-perceived bladder health is unknown. OBJECTIVE: To longitudinally define the GU microbiome in women with self-percieved bladder health sampled across multiple time points over a year. STUDY DESIGN: Women with no reported lower urinary tract dysfunction or symptoms (LUTS) were recruited from six clinical sites and assessed every 6 weeks for 1 year. Voided urine and vaginal samples were longitudinally collected. Self-perceived bladder health was assessed with select items from the LURN comprehensive assessment of self-reported urinary symptoms (CASUS) tool. We defined four life phases as follows: young (18-34 years, nulliparous), midlife (35-45 years, menstruating), transitional (46-60 years, perimenopausal), mature (>60 years, not using vaginal and/or systemic hormone replacement therapy). DNA was extracted from samples, and the V4 region of the 16S rRNA gene was amplified with region-specific primers. The 16S rRNA sequencing on an Illumina NovaSeq. Microbial beta-diversity was calculated using DEICODE to identify microbial taxa that cluster in the samples. Longitudinal volatility analysis was performed using the gemelli plugin. Log-abundance ratios of microbial features were explored and visualized in Qurro. RESULTS: Fifty-four (N = 16 young, N = 16 midlife, N = 15 transitional, N = 7 mature) women were enrolled and provided baseline data. Most women in each life phase (93%-98%) continued to report self-perceived bladder health throughout the 1-year follow-up as assessed by CASUS items. Temporal-based microbial diversity of urinary and vaginal microbiome remained relatively stable over 1 year in all subjects. The GU microbiomes of mature women were distinct and microbially diverse from that of young, midlife, and transitional women, with genera of Gardnerella, Cupriavidus, and Dialister contributory to the microbial features of the mature microbiome. The mature GU microbiome was statistically different (p < 0.0001) from the midlife, transitional, and young microbiome for the log ratio of Gardnerella and Cupriavidus (in the numerator) and Lactobacillus (in the denominator) for voided samples and Gardnerella and Dialister (in the numerator) and Lactobacillus (in the denominator) for vaginal samples. Differences in the GU microbiome were also demonstrated via longitudinal beta-diversity between women developing urinary frequency as reported by CASUS responses or objectively on bladder diary compared to women without urinary frequency. CONCLUSION: In women with a self-perceived healthy bladder, the GU microbiome remained stable in all age groups over a 1 year period. Differences were seen with respect to life phase, where mature women were distinct from all other groups, and with respect to self-reported LUTS.

Financial analysis of minimally invasive sacrocolpopexy compared with native tissue vaginal repair with concomitant hysterectomy.

INTRODUCTION: Minimally invasive sacrocolpopexy (MISCP) is increasingly used for uterovaginal prolapse, but comparative cost data of MISCP versus native tissue vaginal repair (NTR) are lacking. The objective was to determine the cost difference, from a hospital perspective, between MISCP and NTR performed with hysterectomy for uterovaginal prolapse. METHODS: This was a retrospective cohort study at a tertiary care center of women who underwent NTR or MISCP with concomitant hysterectomy in 2021. Hospital charges, direct and indirect costs, and operating margin (revenue minus costs) were obtained from Strata Jazz and compared using SPSS. RESULTS: A total of 82 women were included, 33 MISCP (25 robotic, 8 laparoscopic) versus 49 NTR. Demographic and surgical data were similar, except that MISCP had younger age (50.5 vs 61.1 years, p<0.01). Same-day discharge and estimated blood loss were similar, but operative time was longer for MISCP (204 vs 161 min, p<0.01). MISCP total costs were higher (US$17,422 vs US$13,001, p<0.01). MISCP had higher direct costs (US$12,354 vs US$9,305, p<0.01) and indirect costs (US$5,068 vs US$3,696, p<0.01). Consumable supply costs were higher with MISCP (US$4,429 vs US$2,089, p<0.01), but the cost of operating room time and staff was similar (US$7,926 vs US$7,216, p=0.07). Controlling for same-day discharge, anti-incontinence procedures and smoking, total costs were higher for MISCP (adjusted beta = US$4,262, p<0.01). Mean charges (US$102,060 vs US$97,185, p=0.379), revenue (US$22,214 vs US$22,491, p=0.929), and operating margin (US$8,719 vs US$3,966, p=0.134) were not statistically different. CONCLUSION: Minimally invasive sacrocolpopexy had higher costs than NTR; however, charges, reimbursement, and operating margins were not statistically significantly different between the groups.

Surgical cost of robotic-assisted sacrocolpopexy: a comparison of two robotic platforms.

IMPORTANCE: Robotic assistance in pelvic organ prolapse surgery can improve surgeon ergonomics and instrument dexterity compared with traditional laparoscopy but at increased costs. OBJECTIVE: To compare total costs for robotic-assisted sacrocolpopexy (RSC) between two robotic platforms at an academic medical center. METHODS: Retrospective cohort of Senhance (Ascensus) RSC between 1/1/2019 and 6/30/21 who were matched 2:1 with DaVinci (Intuitive) RSC. Primary outcome was total costs to hospital system; secondarily we evaluated cost sub-categories. Purchase costs of the robotic systems were not included. T-test, chi-square, and Fisher's exact tests were used. A multivariable linear regression was performed to model total costs adjusting for potential confounders. RESULTS: The matched cohort included 75 subjects. The 25 Senhance and 50 DaVinci cases were similar overall, with mean age 60.5 ± 9.7, BMI 27.9 ± 4.7, and parity 2.5 ± 1.0. Majority were white (97.3%) and postmenopausal (86.5%) with predominantly stage III prolapse (64.9%). Senhance cases had longer OR times (Δ = 32.1 min, p = 0.01). There were no differences in concomitant procedures, intraoperative complications, or short-term postoperative complications between platforms (all p > 0.05). On univariable analysis, costs were similar (Senhance $5368.31 ± 1486.89, DaVinci $5741.76 ± 1197.20, p = 0.29). Cost subcategories (medications, supplies, etc.) were also similar (all p > 0.05). On multivariable linear regression, total cost was $908.33 lower for Senhance (p = 0.01) when adjusting for operative time, estimated blood loss, concomitant mid-urethral sling, and use of the GelPoint mini port system. CONCLUSIONS: Despite longer operating times, total cost of robotic-assisted sacrocolpopexy was significantly lower when using the Senhance compared to the DaVinci system.

Surgical correction of the genital hiatus at the time of sacrocolpopexy - a 7-year Markov analysis: a cost-effectiveness analysis.

INTRODUCTION AND HYPOTHESIS: To perform a cost-effectiveness analysis of concurrent posterior repair performed at the time of laparoscopic hysterectomy with sacrocolpopexy over a 7-year time period. We hypothesize it is not cost-effective to perform a posterior colporrhaphy. METHODS: We used TreeAge Pro® to construct a decision model with Markov modeling to compare sacrocolpopexy with and without concurrent posterior repair (SCP and SCP+PR) over a time horizon of 7 years. Outcomes included probability and costs associated with prolapse recurrence, prolapse retreatment, and complications including rectal injury, rectovaginal hematoma requiring reoperation, and postoperative dyspareunia. Cost-effectiveness was defined as an incremental cost-effectiveness ratio (ICER) calculated as ∆ costs /∆ effectiveness and the willingness to pay (WTP) was set at $100,000/QALY. RESULTS: Our model showed that SCP was the dominant strategy, with lower costs (-$ 2681.06) and higher effectiveness (+0.10) compared to SCP+PR over the 7-year period. In two-way sensitivity analyses, we varied the probability of prolapse recurrence after both strategies. Our conclusions would only change if the probability of recurrence after SCP was at least 29.7% higher than after SCP+PR. When varying the probabilities of dyspareunia for both strategies, SCP+PR only became the dominant strategy if the probability of dyspareunia for SCP+PR was lower than the rate of SCP alone. CONCLUSIONS: In this 7-year Markov cost-effectiveness analysis, SCP without concurrent PR was the dominant strategy. SCP+PR costs more with lower effectiveness than SCP alone, due to higher surgical cost of SCP+PR and higher probability of dyspareunia after SCP+PR.

Longitudinal urinary microbiome characteristics in women with urgency urinary incontinence undergoing sacral neuromodulation.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the stability of the urinary microbiome communities in women undergoing sacral neuromodulation (SNM) for urgency urinary incontinence (UUI). We hypothesized that clinical response to SNM therapy would be associated with changes in the urinary microbiome. METHODS: Women completed the Overactive Bladder Questionnaire Short-Form, the International Consultation on Incontinence Questionnaire Short Form, and the Female Sexual Function Index at baseline and 3 months post-SNM implantation. Transurethral urinary specimens were obtained for microbiome analysis at baseline and 3 months postoperatively. The V4 region of the 16S rRNA gene (515F-806R) was amplified with region-specific primers, and Amplicon Sequence Variants (ASVs) were identified with a closed-reference approach of taxonomic classification. Alpha-diversity was calculated using the phylogenetic (i.e., Faith's phylogenetic diversity) and nonphylogenetic metrics (i.e., Shannon diversity, and Pielou's evenness) using the QIIME2 plugin. Longitudinal paired volatility analysis was performed using the DEICODE and Gemelli plugin to account for host specificity across both time and space. RESULTS: Nineteen women who underwent SNM and provided both baseline and 3-month urine samples were included in this analysis. Women reported improvement in objective (number of UUI episodes) and subjective (symptom severity and health-related quality of life) measures. Ninety percent of the bacteria were classified as Bacteroidetes, Firmicutes, Proteobacteria, and Actinobacteria. No significant differences were observed in each subject's beta-diversity at 3 months compared with their baseline microbiome. CONCLUSIONS: Our descriptive pilot study of a cohort of women who had achieved objective and subjective improvements in UUI following SNM therapy demonstrates that the urinary microbiome remains relatively stable, despite variability amongst the cohort.

Salpingo-oophorectomy or surveillance for ovarian endometrioma in asymptomatic premenopausal women: a cost-effectiveness analysis.

BACKGROUND: The lifetime risk of ovarian cancer is 1.9% among women with endometriosis compared with 1.3% among the general population. When an asymptomatic endometrioma is incidentally discovered on imaging, gynecologists must weigh the procedural complications and the potential for subsequent surgical menopause against future ovarian pathology or cancer. OBJECTIVE: We aimed to determine if performing unilateral salpingo-oophorectomy is a more cost-effective strategy for the prevention of death than surveillance for asymptomatic endometriomas. STUDY DESIGN: We created a cost-effectiveness model using TreeAge Pro (TreeAge Software Inc; Williamstown, MA) with a lifetime horizon. Our hypothetical cohort included premenopausal patients with 2 ovaries who did not desire fertility. Those diagnosed with asymptomatic endometrioma underwent either unilateral salpingo-oophorectomy or surveillance (ultrasound 6-12 weeks after diagnosis, then annually). Our primary effectiveness outcome was mortality, including death from ovarian cancer or surgery and all-cause mortality related to surgical menopause (± hormone replacement therapy) if the contralateral ovary is removed. We modeled the probabilities of surgical complications, occult malignancy, development of contralateral adnexal pathology, surgical menopause, use of hormone replacement therapy, and development of ovarian cancer. The costs included surgical procedures, complications, ultrasound surveillance, hormone therapy, and treatment of ovarian cancer, with information gathered from Medicare reimbursement data and published literature. Cost-effectiveness was determined using the incremental cost-effectiveness ratio of Δ costs / Δ deaths with a willingness-to-pay threshold of $11.6 million as the value of a statistical life. Multiple 1-way sensitivity analyses were performed to evaluate model robustness. RESULTS: Our model demonstrated that unilateral salpingo-oophorectomy is associated with improved outcomes compared with surveillance, with fewer deaths (0.28% vs 1.50%) and fewer cases of ovarian cancer (0.42% vs 2.96%). However, it costs more than sonographic surveillance at $6403.43 vs $5381.39 per case of incidental endometrioma. The incremental cost-effectiveness ratio showed that unilateral salpingo-oophorectomy costs $83,773.77 per death prevented and $40,237.80 per case of ovarian cancer prevented. As both values were well below the willingness-to-pay threshold, unilateral salpingo-oophorectomy is cost-effective and is the preferred strategy. If unilateral salpingo-oophorectomy were chosen over surveillance for premenopausal patients with incidental endometriomas, 1 diagnosis of ovarian cancer would be prevented in every 40 patients and 1 death averted in every 82 patients. We performed 1-way sensitivity analyses for all input variables and determined that there were no reasonable inputs that would alter our conclusions. CONCLUSION: Unilateral salpingo-oophorectomy is cost-effective and is the preferred strategy compared with surveillance for the management of incidental endometrioma in a premenopausal patient not desiring fertility. It incurs fewer deaths and fewer cases of ovarian cancer with costs below the national willingness-to-pay thresholds.

Assault-related injuries reported to police and treated by healthcare providers in the United States.

Research suggests that assault-related injuries known by the police significantly differ from those known by healthcare providers, but the magnitude and nature of these differences are poorly understood. To address this gap, our study examined the empirical differences between assault-related injuries reported to police and treated by healthcare providers. In June of 2021, we analyzed the National Crime Victimization Survey (1993-2019) to estimate the prevalence of police reporting and healthcare use among 5093 nonfatal victimizations that caused injury and were either reported to the police or treated by healthcare in the United States. Quasi-Poisson models identified the factors associated with whether people who sustained the injuries used healthcare (v. only reported to police) and reported to police (v. only used healthcare). Among victimizations that caused only minor injuries, 43% involved only a police report, 11% involved only healthcare, and 46% involved both services. Among victimizations that caused serious injuries, 14% involved only a police report, 13% involved only healthcare, and 73% involved both services. Whether people with violent injuries used healthcare (v. only reported to police) and reported to police (v. only used healthcare) was significantly associated with 13 different person- and incident-level factors. The number and nature of assault-related injuries reported to law enforcement significantly differ from those treated by healthcare providers. Therefore, public health efforts to link police and healthcare data are warranted and recommended.

Risk factors for the development of acute pyelonephritis in women with a positive urine culture.

INTRODUCTION: In treating lower urinary tract symptoms (LUTS), the risk of overtreatment with antibiotics must be reconciled with the risk of an untreated urinary tract infection (UTI) progressing to acute pyelonephritis (APN). Using Cerner HealthFacts, a longitudinal clinical informatics database, we aimed to determine risk factors associated with the development of APN from UTI in an effort to guide the initiation of empiric antibiotics. METHODS: We queried the Cerner HealthFacts database for women over age 18 with a positive urine culture. Any patient with an International Classification of Disease (ICD) code indicating chronic pyelonephritis was excluded. Development of APN within 30 days of the positive culture, specified by ICD coding, was our primary outcome. Patient and facility factors were assessed as potential risk factors for the development of APN using multivariable regression. RESULTS: Out of 58 344 women with a positive urine culture, 3.9% (2296) developed APN. Mean patient age was 54.4 ± 25.3 years. Overall, 12 variables were predictive for APN and 11 variables were protective against APN. Presence of obstructive and reflux uropathies (OR 4.58), presentation to an acute care facility (OR 3.19), urinary retention (OR 2.30), history of UTI (OR 2.19), and renal comorbidities (OR 2.07) conferred the highest odds of APN development. The most protective variable against APN development was cognitive impairment (OR 0.49). CONCLUSIONS: Identified risk factors associated with APN development may aid decisions regarding empiric antibiotic initiation for patients presenting with LUTS while awaiting urine culture results. The relationship between cognitive impairment and progression to APN deserves further study.

Sacrocolpopexy experience with a novel robotic surgical platform.

INTRODUCTION AND HYPOTHESIS: The objective was to describe early experience performing sacrocolpopexy using a novel robotic surgical platform. METHODS: This is a case series of all women who underwent robotic-assisted sacrocolpopexy using a new robotics platform (TransEnterix Senhance) between January 2019 and July 2021. All sacrocolpopexies were performed by a single Female Pelvic Medicine and Reconstructive surgeon at a large academic institution. Perioperative information including complications was abstracted from the medical record. Anatomical recurrence was defined as any anatomical point at or past the hymen (≥0). Data are descriptive, with Mann-Whitney U test used for comparison of operative time between the first and second half of the patients. RESULTS: A total of 25 sacrocolpopexies were performed using the new robotics platform. Mean age was 62.3 years (±9.2) and mean BMI was 26.5 (±3.8). Ten (40.0%) patients had a prior hysterectomy. Most (n = 21, 84.0%) had stage III or IV prolapse preoperatively. Mean operative time was 210.2 min (±48.6) and median estimated blood loss was 35 ml (IQR 25-50). Mean operative time decreased between the first and second half of the patients (231.7 min vs 190.3 min, p = 0.047). There were no major intraoperative complications. Median follow-up time was 16 weeks (IQR 4-34) and there were no subjective recurrences or retreatments during this period. Two patients (8.0%) had anatomical recurrence without subjective bother. There were two postoperative readmissions (8.0%) within 30 days for small bowel obstruction, one treated surgically and the other with nonsurgical management. CONCLUSIONS: Our case series demonstrates feasibility and successful early adoption of a new robotics platform for robotic sacrocolpopexy.

Disparity in Medicare payments by gender and training track in female pelvic medicine and reconstructive surgery.

BACKGROUND: Gender disparities in medicine have been demonstrated in the past, including differences in the attainment of roles in administration and in physician income. OBJECTIVE: Our objective was to determine the differences in Medicare payments based on the provider gender and training track among female pelvic medicine and reconstructive surgeons. STUDY DESIGN: Medicare payments from the Provider Utilization Aggregate Files were used to determine the payments made by Medicare to urogynecologists. This database was merged with the National Provider Identifier registry with information on subspecialty training, years since graduation, and the geographic pricing cost index used for Medicare payment adjustments. Physicians with <90% female patients and those who graduated medical school <7 years ago in obstetrics and gynecology or <8 years ago in urology were excluded. The effects of gender, specialty of training, number of services provided, years of practice, and geographic pricing cost index on physician reimbursement were evaluated using linear mixed modeling. RESULTS: A total of 578 surgeons with female pelvic medicine and reconstructive surgery subspecialty training met the inclusion criteria. Of those, 517 (89%) were trained as gynecologists, whereas 61 (11%) were trained as urologists. Furthermore, 265 (51%) of the gynecology-trained surgeons and 39 (80%) of the urology-trained surgeons were women. Among the urology-trained surgeons, the median female surgeon was paid $85,962 and their male counterparts were paid $121,531 (41% payment difference). In addition, urology-trained female pelvic medicine and reconstructive surgery surgeons performed a median of 1135 services and their male counterparts performed a median of 1793 services (57% volume difference). Similarly, among gynecology-trained surgeons, the median female payment was $59,277 with 880 services performed, whereas male gynecology-trained surgeons received a median of $66,880 with 791 services performed, representing a difference of 12% in payments and 11% in services. With linear mixed modeling, male physicians were paid more than female physicians while controlling for specialty training, number of services performed, years of practice, and geographic pricing cost index (P<.001). CONCLUSION: Although Medicare payments are based on an equation, differences in reimbursement by physician gender exist in female pelvic medicine and reconstructive surgery with female surgeons receiving lower payments from Medicare. The differences in reimbursement could not be solely explained by differences in patient volume, area of practice, or years of experience alone, suggesting that, similar to other fields in medicine, female surgeons in female pelvic medicine and reconstructive surgery are not paid as much as their male counterparts.

Assessing pelvic organ prolapse recurrence after minimally invasive sacrocolpopexy: does mesh weight matter?

INTRODUCTION AND HYPOTHESIS: There has been a trend toward the use of ultra-lightweight mesh types for minimally invasive sacrocolpopexy. We hypothesized that ultra-lightweight mesh would have a greater proportion of composite anatomical pelvic organ prolapse recurrence than lightweight mesh. METHODS: Retrospective cohort study of minimally invasive sacrocolpopexies at two academic institutions from 2009 to 2016. Our primary outcome was composite anatomical prolapse recurrence, defined as prolapse beyond the hymen or retreatment with pessary or surgery, compared between ultra-lightweight (≤21 g/m2 [range 19-21]) and lightweight (>21 g/m2 [range 35-50]) mesh types. We assessed time to prolapse recurrence using Kaplan-Meier and Cox regression. RESULTS: The cohort consisted of 1,272 laparoscopic (n = 530, 41.7%) and robotic-assisted sacrocolpopexies (n = 742, 58.4%). Lightweight mesh was used in 745 procedures (58.6%) and ultra-lightweight mesh in 527 (41.4%). The lightweight mesh had longer median follow-up than the ultra-lightweight group (344 [IQR 50-670] vs 143 days [IQR 44-379], p < 0.01). There was no difference in composite anatomical prolapse recurrence between lightweight and ultra-lightweight mesh (54 [7.2%] vs 35 [6.6%], p = 0.68). Ultra-lightweight mesh demonstrated a shorter time to prolapse recurrence (p < 0.01), which remained significant on multivariate Cox regression (HR 2.38 [95% CI 1.47-3.87]). The lightweight mesh had significantly more mesh complications (43 [5.8%] vs 7 [1.3%], p < 0.01). CONCLUSIONS: Ultra-lightweight mesh for minimally invasive sacrocolpopexy was not associated with a higher proportion of composite anatomical prolapse recurrence; however, it was associated with a shorter time to recurrence. Longer follow-up is needed to assess the clinical importance of this finding, particularly given the trade-off of more complications with lightweight mesh.

Improving fetal congenital heart disease screening using a checklist-based approach.

To determine if using a checklist of specific ultrasound image criteria to screen the fetal heart improves the cardiac exam completion rate, defined as the ability to classify the heart as normal or abnormal. This is a retrospective cohort study of patients with singleton pregnancies who underwent a fetal anatomy survey between 18 and 28 weeks' gestation. A checklist was used from 1 September 2015 to 31 March 2016 to categorize exams as complete-normal, complete-abnormal, or incomplete. Performance was compared with a 7-month period prior to checklist introduction (1 December 2014 to 30 June 2015). Checklist utilization improved the cardiac exam completion rate by 8.9%. With the checklist, 1083 of 1202 exams (90.1%) were completed compared to 987 of 1193 (82.7%) pre-checklist, P < .001. We did not detect a change in cases classified as abnormal and referred for echocardiography: 25 (2.1%) with the checklist and 16 (1.3%) pre-checklist, P = .16. We did not detect more congenital heart disease (CHD), 12 (1.0%) with checklist screening, 5 (0.4%) pre-checklist, P = .14. Critical CHD was not missed in either group. Using the checklist improved the cardiac exam completion rate. There was no change in congenital heart disease detection.

Comparing laparoscopic and robotic sacrocolpopexy surgical outcomes with prior versus concomitant hysterectomy.

INTRODUCTION AND HYPOTHESIS: The objective was to compare surgical outcomes after prior hysterectomy versus concomitant hysterectomy with laparoscopic/robotic minimally invasive sacral colpopexy (MISC). METHODS: Using all MISC from 2009 to 2014, patient sociodemographic and surgical data were compared between MISC with prior versus concomitant hysterectomy. Operative time (skin incision to closure) was compared with linear regression. Logistic regression compared complications, a composite variable including ≥1 transfusion, infection, readmission, reoperation, bowel obstruction/ileus, conversion to laparotomy, bowel/bladder injury, or mesh complication. Logistic regression compared prolapse recurrence defined as retreatment (pessary/surgery) or postoperative POP-Q points ≥ 0. RESULTS: Eight hundred and sixteen patients were 59.6 ± 8.7 years old and predominantly Caucasians (97.8%), with BMI 27.4 ± 4.5 and predominantly POP-Q stage III prolapse (69.9%). Operative time was 205.0 ± 69.0 min. Concomitant hysterectomy increased operative time 17.8 min (p = 0.004) adjusting for age, POP-Q stage, total vaginal length, perineal body, lysis of adhesions or perineorrhaphy, changes in operating personnel (scrub tech/circulating nurse), case order during the day, and preoperative stress incontinence. Complications occurred in 15.8% and were more likely with prior hysterectomy (odds ratio [OR] = 2.30, 95% confidence interval [CI] = 1.43-3.70) adjusting for preoperative genital hiatus and perineal body, concomitant midurethral sling, obesity, and immunosuppression. During a follow-up of 31 weeks, 7.8% had prolapse recurrence with no impact from concomitant hysterectomy (OR = 0.96, 95% CI 0.41-2.24). Post-hoc power calculation would have required an unattainable size of >2,800 per group for this outcome. CONCLUSIONS: For MISC, concomitant hysterectomy is associated with longer operative time but lower risk of complications. There was no impact of concomitant hysterectomy on prolapse recurrence, but longer follow-up may be needed for this outcome.

The impact of prior prolapse repairs on surgical outcomes with minimally invasive sacral colpopexy.

INTRODUCTION AND HYPOTHESIS: To determine whether prior prolapse repair has an impact on operative time, surgical complications, and prolapse recurrence with minimally invasive sacral colpopexy (MISC). METHODS: This was a retrospective study of all laparoscopic and robotic MISC procedures performed from January 2009 to July 2014 at the University of Pittsburgh Medical Center. Patient demographics, clinical and surgical data were compared in women who underwent MISC for initial repair versus those undergoing MISC for recurrence after prior prolapse surgery. Our primary outcome was operating room (OR) time (skin incision to closure) using linear regression. Logistic regression compared complications (a composite variable considered present if any major complication occurred) and prolapse recurrence (any POP-Q point ≥0 or retreatment). RESULTS: Of 816 subjects, the mean age was 59.6 ± 8.7, with mean BMI 27.0 ± 3.0 in a primarily Caucasian population (97.8%). Subjects had predominantly POP-Q stage III prolapse (69.9%), and 21.3% reported prior prolapse repair. OR time was 205.0 ± 69.0 min. Prior prolapse repair did not impact OR time (p = 0.25) after adjusting for age, concomitant procedures, POP-Q measurements, changes in OR personnel, case order in the day, and preoperative stress incontinence. Complications occurred in 15.8% but were not impacted by prior prolapse repair (OR = 0.94, 95% CI = 0.53-1.67) after adjusting for potential confounders. During a median follow-up of 31 weeks, 7.8% had recurrence with no impact from prior prolapse surgery (OR = 1.557, 95% CI = 0.67-3.64) after adjusting for potential confounders. CONCLUSIONS: We were unable to demonstrate increased OR time, complications, or prolapse recurrence for MISC based on history of prior prolapse repair. Longer follow-up is needed to confirm the lack of difference in prolapse recurrence rates.

Building capacity for injury prevention: a process evaluation of a replication of the Cardiff Violence Prevention Programme in the Southeastern USA.

OBJECTIVES: Violence is a major public health problem in the USA. In 2016, more than 1.6 million assault-related injuries were treated in US emergency departments (EDs). Unfortunately, information about the magnitude and patterns of violent incidents is often incomplete and underreported to law enforcement (LE). In an effort to identify more complete information on violence for the development of prevention programme, a cross-sectoral Cardiff Violence Prevention Programme (Cardiff Model) partnership was established at a large, urban ED with a level I trauma designation and local metropolitan LE agency in the Atlanta, Georgia metropolitan area. The Cardiff Model is a promising violence prevention approach that promotes combining injury data from hospitals and LE. The objective was to describe the Cardiff Model implementation and collaboration between hospital and LE partners. METHODS: The Cardiff Model was replicated in the USA. A process evaluation was conducted by reviewing project materials, nurse surveys and interviews and ED-LE records. RESULTS: Cardiff Model replication centred around four activities: (1) collaboration between the hospital and LE to form a community safety partnership locally called the US Injury Prevention Partnership; (2) building hospital capacity for data collection; (3) data aggregation and analysis and (4) developing and implementing violence prevention interventions based on the data. CONCLUSIONS: The Cardiff Model can be implemented in the USA for sustainable violent injury data surveillance and sharing. Key components include building a strong ED-LE partnership, communicating with each other and hospital staff, engaging in capacity building and sustainability planning.

Cystoscopy at the time of benign hysterectomy: a decision analysis.

BACKGROUND: Gynecologists debate the optimal use for intraoperative cystoscopy at the time of benign hysterectomy. Although adding cystoscopy leads to additional up-front cost, it may also enable intraoperative detection of a urinary tract injury that may otherwise go unnoticed. Prompt injury detection and intraoperative repair decreases morbidity and is less costly than postoperative diagnosis and treatment. Because urinary tract injury is rare and not easily studied in a prospective fashion, decision analysis provides a method for evaluating the cost associated with varying strategies for use of cystoscopy. OBJECTIVE: The objective of the study was to quantify costs of routine cystoscopy, selective cystoscopy, or no cystoscopy with benign hysterectomy. STUDY DESIGN: We created a decision analysis model using TreeAge Pro. Separate models evaluated cystoscopy following abdominal, laparoscopic/robotic, and vaginal hysterectomy from the perspective of a third-party payer. We modeled bladder and ureteral injuries detected intraoperatively and postoperatively. Ureteral injury detection included false-positive and false-negative results. Potential costs included diagnostics (imaging, repeat cystoscopy) and treatment (office/emergency room visits, readmission, ureteral stenting, cystotomy closure, ureteral reimplantation). Our model included costs of peritonitis, urinoma, and vesicovaginal/ureterovaginal fistula. Complication rates were determined from published literature. Costs were gathered from Medicare reimbursement as well as published literature when procedure codes could not accurately capture additional length of stay or work-up related to complications. RESULTS: From prior studies, bladder injury incidence was 1.75%, 0.93%, and 2.91% for abdominal, laparoscopic/robotic, and vaginal hysterectomy, respectively. Ureteral injury incidence was 1.61%, 0.46%, and 0.46%, respectively. Hysterectomy costs without cystoscopy varied from $884.89 to $1121.91. Selective cystoscopy added $13.20-26.13 compared with no cystoscopy. Routine cystoscopy added $51.39-57.86 compared with selective cystoscopy. With the increasing risk of injury, selective cystoscopy becomes cost saving. When bladder injury exceeds 4.48-11.44% (based on surgical route) or ureteral injury exceeds 3.96-8.95%, selective cystoscopy costs less than no cystoscopy. Therefore, if surgeons estimate the risk of injury has exceeded these thresholds, cystoscopy may be cost saving. However, for routine cystoscopy to be cost saving, the risk of bladder injury would need to exceed 20.59-47.24% and ureteral injury 27.22-37.72%. Model robustness was checked with multiple 1-way sensitivity analyses, and no relevant thresholds for model variables other than injury rates were identified. CONCLUSION: While routine cystoscopy increased the cost $64.59-83.99, selective cystoscopy had lower increases ($13.20-26.13). These costs are reduced/eliminated with increasing risk of injury. Even a modest increase in suspicion for injury should prompt selective cystoscopy with benign hysterectomy.

A cost-minimization analysis of treatment options for postmenopausal women with dysuria.

BACKGROUND: Empiric therapy for urinary tract infection is difficult in postmenopausal women because of the higher rates of confounding lower urinary tract symptoms and differential resistance profiles of uropathogens in this population. OBJECTIVE: The objective of the study was to determine the least costly strategy for treatment of postmenopausal women with the primary complaint of dysuria. STUDY DESIGN: We performed a cost minimization analysis modeling the following clinical options: (1) empiric antibiotic therapy followed by urine culture, (2) urinalysis with empiric antibiotic therapy only if positive nitrites and leukocyte esterase, or (3) waiting for culture prior to initiating antibiotics. For all strategies we included nitrofurantoin, trimethoprim/sulfamethoxazole, fosfomycin, ciprofloxacin, or cephalexin. Pathogens included Escherichia coli, Enterococcus faecalis, Klebsiella pneumonaie, or Proteus mirabalis. Pathogens, resistance, treatment success, and medication side effects were specific to postmenopausal women. RESULTS: Cost minimization modeling with TreeAge Pro assumed 73.4% of urinary tract infections were caused by Escherichia coli with 24.4% resistance to nitrofurantoin, trimethoprim/sulfamethoxazole. With our assumptions, empiric antibiotics with nitrofurantoin, trimethoprim/sulfamethoxazole was the least costly approach ($89.64/patient), followed by waiting for urine culture ($97.04/patient). Except for empiric antibiotics with fosfomcyin, empiric antibiotics was always less costly than using urinalysis to discriminate antibiotic use. This is due to the cost of urinalysis ($38.23), high rate of both urinary tract infection (91%), and positive urinalysis (69.3%) with dysuria in postmenopausal women and resultant high rate of antibiotic use with or without urinalysis. Options with fosfomycin were the most expensive because of the highest drug costs ($98/dose), and tornado analyses showed fosfomycin cost was the most impactful variable for model outcomes. Sensitivity analyses showed empiric fosfomycin became the least costly option if drug costs were $25.80, a price still more costly than almost all modeled baseline drug costs. This outcome was largely predicated on low resistance to fosfomycin. Conversely, ciprofloxacin was never the least costly option because of higher resistance and side effect cost, even if the drug cost was $0. We modeled 91% positive urine culture rate in postmenopausal women with dysuria; waiting for the urine culture prior to treatment would be the least costly strategy in a population with a predicted positive culture rate of <65%. CONCLUSION: The least costly strategy was empiric antibiotics with nitrofurantoin and trimethoprim/sulfamethoxazole, followed by waiting on culture results. Local resistance patterns will have an impact on cost minimization strategies. Empiric fosfomycin would be least costly with reduced drug costs, even at a level at which drug costs were higher than almost all other antibiotics. In a population with high posttest probability of positive urine culture, urinalysis adds unnecessary cost. Antibiotic stewardship programs should continue efforts to decrease fluoroquinolone use because of high resistance, side effects, and increased cost.

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.