Progression-free survival is a weakly predictive surrogate end-point for overall survival in follicular lymphoma: A systematic review and meta-analysis.

Although progression-free survival (PFS) is a commonly used surrogate end-point for clinical trials of follicular lymphoma (FL), no analyses have evaluated the strength of surrogacy for PFS with overall survival (OS). A systematic review was performed and 20 studies (total participants, 10 724) met final inclusion criteria. PFS was weakly associated with OS (correlation coefficient; 0.383, p < 0.001). The coefficient of determination was 0.15 (95% CI: 0.002-0.35) suggesting 15% of OS variance could be explained by changes in PFS. This challenges the role for PFS as a surrogate end-point for clinical trials and drug approvals.

Trends, Outcomes, and Economic Implications of Peritoneal Dialysis-Associated Peritonitis Hospitalizations: A National Cohort Study.

INTRODUCTION: Peritoneal dialysis-associated peritonitis (PDAP) is a serious complication of peritoneal dialysis, associated with significant morbidity, modality transition, and mortality. Here, we provide an update on the national burden of this significant complication, highlighting trends in demographics, treatment practices, and in-hospital outcomes of PDAP from 2016 to 2020. METHODS: Utilizing a national all-payer dataset of hospitalizations in the USA, we conducted a retrospective cohort study of adult hospitalizations with a primary diagnosis of PDAP from 2016 to 2020. We analyzed demographic, clinical, and hospital-level data, focusing on in-hospital mortality, PD catheter removal, length of stay, and healthcare expenses. Multivariable logistic regression adjusted for demographic and clinical covariates was employed to identify risk factors associated with adverse outcomes. RESULTS: There was a stable burden of annual PDAP admissions from 2016 to 2020. Healthcare expenditures associated with PDAP were high, totaling over USD 75,000 per admission. Additionally, our data suggest geographic inconsistencies in treatment patterns, with treatment at western and teaching hospitals associated with increased rates of catheter removal relative to northeastern and non-teaching centers and a mean cost of nearly USD 55,000 more in Western states compared to Midwest states. 23.2% of episodes resulted in the removal of the PD catheter. Risk factors associated with adverse outcomes included older age, higher Charlson comorbidity index scores, peripheral vascular disease, and the need for vasopressors. CONCLUSION: PDAP is a major cause of mortality among PD patients, and there is a vital need for future studies to examine the impact of hospital location and teaching status on PDAP outcomes, which can inform treatment practices and resource allocation.

Timing of Trial of Void After Radical Hysterectomy: Long-Term Urinary Outcomes at Two Academic Tertiary Care Institutions.

INTRODUCTION AND HYPOTHESIS: Many patients develop bladder symptoms after radical hysterectomy. This study compared urinary outcomes following radical hysterectomy based on trial of void (TOV) timing (pre-discharge TOV versus post-discharge TOV). METHODS: A retrospective non-inferiority study of patients at two academic tertiary referral centers who underwent radical hysterectomy between January 2010 and January 2020 was carried out. Patients were stratified according to timing of postoperative TOV: either pre-discharge or post-discharge from the hospital. Short-term urinary outcomes (including passing TOV, representation with retention) and long-term de novo urinary dysfunction (defined as irritative voiding symptoms, urgency, frequency, nocturia, stress or urgency incontinence, neurogenic bladder, and/or urinary retention) were extracted from the medical record. We hypothesized that the proportion of patients who failed pre-discharge TOV would be within a 15% non-inferiority margin of post-discharge TOV. RESULTS: A total of 198 patients underwent radical hysterectomy for cervical (118 out of 198; 59.6%), uterine (36 out of 198; 18.2%), and ovarian (29 out of 198; 14.6%) cancer. One hundred and nineteen patients (119 out of 198, 60.1%) underwent pre-discharge TOV, of whom 14 out of 119 (11.8%) failed. Of the post-discharge TOV patients (79 out of 198, 39.9%), 5 out of 79 (6.3%) failed. The proportion of patients who failed a pre-discharge TOV was within the non-inferiority margin (5.4% difference, p = 0.23). A greater proportion of patients in the post-discharge TOV group developed long-term de novo urinary dysfunction (27.2% difference, p = 0.005). Median time to diagnosis of de novo urinary dysfunction was 0.5 years (range 0-9) in the pre-discharge TOV group versus 1.0 year (range 0-6) in the post-discharge TOV group (p > 0.05). CONCLUSIONS: In this study, pre-discharge TOV had non-inferior short-term outcomes and improved long-term outcomes.

Financial toxicity in BRCA1 and BRCA2 carriers.

OBJECTIVE: Financial toxicity (FT), the cumulative financial burden experienced due to medical care, is a well-established adverse effect of healthcare. Patients with BRCA mutations have significantly increased cancer risks compared to non-affected individuals, requiring more frequent screenings and, at times, prophylactic surgery, increasing their risk for FT. Our primary aim in this study was to describe rates of FT among BRCA carriers. METHODS: We performed a novel, cross-sectional study of FT in BRCA1/2 carriers. Participants were recruited via phone and/or email to complete consents and surveys on REDCap. The FACIT-COST tool, a validated tool for measuring FT, was used to assess FT; scores were divided into tertiles, with high FT defined as COST score < 24. RESULTS: 265 BRCA positive female participants met enrollment criteria; 76 (28.7%) consented to participate and completed the survey. Participants were primarily non-Hispanic White (97.4%), privately insured (82.9%), and employed full time (67.1%). A significant proportion (22.7%) of participants reported delaying or avoiding care secondary to finances. No statistically significant association was seen between financial toxicity groups and analyzed demographics. Participants with high FT were more likely to engage in all surveyed cost-saving measures, with 41.7% of participants reporting delays/avoidance of care due to cost (p = 0.02). CONCLUSIONS: This study of FT in BRCA carriers shows that financial toxicity exists as an issue in this high-risk patient population. This work serves as the first description of FT in BRCA mutation carriers and highlights the importance of incorporating routine counseling on cost when discussing recommendations for screening and clinical care with this patient population.

A randomized trial comparing the 52-mg levonorgestrel system with combination oral contraceptives for treatment of heavy menstrual bleeding.

BACKGROUND: The levonorgestrel intrauterine system and combined oral contraceptives are the 2 most commonly used nonsurgical treatments for heavy menstrual bleeding in the United States. However, there are limited data on their relative effectiveness and on their impact on bleeding-specific quality of life. OBJECTIVE: This study aimed to compare the effectiveness of the 52-mg levonorgestrel intrauterine system with that of combined oral contraceptives for improving quality of life among individuals who self-report heavy menstrual bleeding. We hypothesized that the levonorgestrel intrauterine system would be more effective than combined oral contraceptives at 6 and 12 months after treatment. STUDY DESIGN: We conducted a pragmatic randomized trial of individuals who self-reported heavy menstrual bleeding. Individuals were eligible if they did not have contraindications to either the levonorgestrel intrauterine system or combined oral contraceptives and were determined to have a nonstructural cause of heavy menstrual bleeding. Eligible and consenting participants were randomly assigned in a 1:1 ratio to receive a 52-mg levonorgestrel intrauterine system or a monophasic 30- or 35-µg ethinyl estradiol-containing combined oral contraceptive. The main outcome was mean change in bleeding-related quality of life, measured by the 20-question Menstrual Bleeding Questionnaire (score range, 0-75) at 6 and 12 months. Differences in group means and confidence intervals for the Menstrual Bleeding Questionnaire score were computed by multivariable linear mixed-effects regression; 24 participants per group were needed to detect a 10-point difference in change in mean Menstrual Bleeding Questionnaire score between individuals treated with the levonorgestrel intrauterine system and those treated with combined oral contraceptives at each follow-up time point. RESULTS: A total of 62 individuals were randomly assigned to treatment (n=29 allocated to levonorgestrel intrauterine system and n=33 allocated to combined oral contraceptives) and included in the intention-to-treat analyses; 19 of 29 received the levonorgestrel intrauterine system and 31 of 33 received combined oral contraceptives. Eleven percent identified as Black or African American and 44% identified as Hispanic or Latina. Participant characteristics were similar among study groups. Bleeding-related quality of life increased in both study arms, as reflected by a significant decrease in Menstrual Bleeding Questionnaire scores beginning at 6-week follow-up. In the main intention-to-treat analyses (n=62), there were no differences in mean change in Menstrual Bleeding Questionnaire scores at 6 months (difference=-2.5; 95% confidence interval, -10.0 to +5.0) or 12 months (difference=-1.1; 95% confidence interval, -8.7 to +6.5). Findings were similar in the subsets of participants with any follow-up visits (n=52) and who completed all follow-up visits (n=42). In the per-protocol analyses (n=47), a significantly greater decrease in Menstrual Bleeding Questionnaire score was observed in the levonorgestrel intrauterine system arm at 6 months after treatment (difference=-7.0; 95% confidence interval, -13.8 to -0.2) but not at 12 months (difference=-4.8; 95% confidence interval, -11.8 to 2.3) compared with the combined oral contraceptive arm. CONCLUSION: No differences in change of bleeding-related quality of life were observed between the levonorgestrel intrauterine system and combined oral contraceptives at 6 or 12 months. Patients should be counseled that the levonorgestrel intrauterine system and combined oral contraceptives are both effective options for improving bleeding-related quality of life.

Survey of young women with breast cancer to identify rates of fertility preservation (FP) discussion and barriers to FP care.

PURPOSE: To identify the proportion of reproductive age women with breast cancer that engaged in a fertility preservation discussion and reproductive endocrinology and infertility (REI) consultation. METHODS: This cross-sectional survey recruited women 18-42 years who were diagnosed with breast cancer from 2006 to 2016 by phone or email and asked them to complete an online survey. Demographic characteristics, barriers to FP, utilization of FP consultation, and FP procedures (oocyte and embryo cryopreservation) were analyzed. RESULTS: A majority of women (64%) did not have FP discussed by any provider. Older women and those who were parents at the time of diagnosis were less likely to engage in a FP discussion. However, there were no significant differences in partner status or cancer stage between women with or without FP discussions. Of the women who desired future children prior to the cancer diagnosis, 93% received chemotherapy; however, only 34% of these women had a consultation with an REI. The most common reasons for declining FP consultation were already having their desired number of children (41%), financial barriers (14%), and concern about delaying cancer treatment and cancer recurrence (12%). Forty percent of women who desired future children and met with an REI pursued FP procedures. CONCLUSION: Younger women were more likely to receive FP counseling. FP consultations and procedures were low even in women who desired future fertility, with the predominant barriers being cost, fears concerning a delay in cancer treatment, and future cancer recurrence.

The association between trial of labor after cesarean in obese patients and adverse maternal outcomes.

PURPOSE: We hypothesized that among obese patients with a history of cesarean birth, a TOLAC is associated with decreased composite maternal adverse outcomes (CMAO) compared to planned repeat low transverse cesarean section (RLTCS). METHODS: In this population-based cross-sectional study using the National Birth Certificate database from 2016 to 2020, we compared obese patients who attempted TOLAC at term (≥ 37 weeks estimated gestational age) to planned RLTCS. The primary outcome was a CMAO, defined as delivery complications, including intensive care unit (ICU) admission, uterine rupture, unplanned hysterectomy, or maternal blood transfusion. RESULTS: Overall, 794,278 patients met inclusion criteria for the study; 126,809 underwent a TOLAC, and 667,469 had a planned RLTCS. The overall CMAO was significantly higher for patients undergoing TOLAC (9.0 per 1000 live births) compared to RLTCS (5.3 per 1000 live births; aRR 1.64, 95% CI 1.53-1.75). CONCLUSION: This data demonstrate that in obese patients with prior cesarean birth, a trial of labor is associated with increased maternal morbidity when compared to a planned repeat cesarean birth.

Breast-Specific Sensuality in Breast Cancer Survivors: Sexually Active or Not.

BACKGROUND: We sought to better understand breast-specific sensuality (BSS) in sexually inactive breast cancer survivors. METHODS: We conducted an anonymous cross-sectional survey of breast cancer survivors during surveillance appointments from 2014 to 2016. Sexual inactivity was defined as no sexual activity within 4 weeks prior. Categorical data were analyzed using Fisher's exact test. Multiple logistic regression adjusted for age and menopausal status, and Firth's bias correction accommodated sparse data. RESULTS: Of 585 respondents, 546 (93.3%) were between the ages of 40 and 79 years, of whom 285 (48.7%) were sexually inactive. Favorable post-treatment appearance satisfaction was reported by 413 (71.0%) respondents. Sexually inactive respondents were more likely to score discomfort with their partner seeing their chest after surgery compared with sexually active respondents (41 [20.4%] vs. 34 [11.4%]; p = 0.002). Both sexually inactive and active respondents reported that their chest was important in intimacy after surgery but at significantly different rates (117 [44.3%] vs. 217 [72.6%]; p < 0.001). Post-surgical appearance satisfaction for sexually inactive respondents was positively associated with level of comfort with partner seeing their chest after surgery (p < 0.001) and with rating of a pleasurable caress of the treated breast (p < 0.001). CONCLUSIONS: Over 40% of sexually inactive respondents reported their chest was important in intimacy after surgery, suggesting that BSS may be a route to intimacy for sexually inactive breast cancer survivors. Post-surgical breast appearance satisfaction significantly correlated with comfort being seen by one's partner and appreciation of a pleasurable breast caress. Optimizing breast cancer surgical aesthetic outcomes may improve survivorship.

Sexual health and function among patients receiving systemic therapy for primary gynecologic cancers.

OBJECTIVE: Sexual dysfunction has been reported after gynecologic cancer treatment but few studies have examined sexual function during treatment. Our objectives were to describe sexual function among women receiving systemic therapy for gynecologic cancers and to compare sexual function between women receiving upfront treatment versus treatment for cancer recurrence. METHODS: We conducted a prospective study of women 18yo and older receiving systemic therapy for gynecologic cancer in the upfront or recurrent setting. Patients receiving radiation were excluded. Participants completed a survey with questions from the Patient Reported Outcome Measurement Information System (PROMIS) SexFS and Female Sexual Function Index (FSFI). Clinical information was collected from chart review. Statistical analysis included t-test, Wilcoxon rank sum test, and Fisher's exact test. RESULTS: Of 145 patients approached, 100 (69%) enrolled and 97 (67%) completed the survey. Median age was 65yo. Most patients had ovarian cancer (58%), then endometrial cancer (34%) and cervical cancer (8%). Fifty-two (54%) were receiving recurrent treatment and 45 (46%) upfront treatment. Thirty-eight (76%) in the recurrent group and 34 (75%) in the upfront group hadn't been sexually active in the last month (p = 1.0); however, 61 (67%) participants reported a desire for future sexual activity. Of the 31 patients who completed all FSFI questions, the median FSFI score was 24.0 and 21 (68%) had sexual dysfunction. Vaginal dryness was more common among patients receiving recurrent treatment (p = 0.09) while a "health condition" was a more common reason for sexual inactivity in the upfront setting (p = 0.07). CONCLUSION: Many patients receiving systemic therapy for gynecologic cancers are willing to discuss sexual function. Most patients reported sexual dysfunction and weren't currently sexually active. Understanding patients' sexual function concerns will allow providers to intervene.

Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial.

BACKGROUND: The efficacy of intradetrusor onabotulinumtoxinA injections for the management of idiopathic overactive bladder has been well-established. The injections are typically performed in the office setting using local analgesia, most commonly a 20 to 30-minute intravesical instillation of lidocaine. There are limited data evaluating alternative bladder analgesics. OBJECTIVE: To compare pain scores with preprocedure oral phenazopyridine vs intravesical lidocaine in women undergoing intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder. STUDY DESIGN: Nonpregnant adult females with idiopathic overactive bladder, scheduled for office injection of 100 units of intradetrusor onabotulinumtoxinA were randomized to either 200 mg of oral phenazopyridine taken 1 to 2 hours preprocedure or a 20-minute preprocedure intravesical instillation of 50 mL of 2% lidocaine. We excluded participants with neurogenic bladders, and those who had received intradetrusor onabotulinumtoxinA injections in the previous 12 months. The primary outcome was pain measured by a 100-mm visual analog scale. Demographic characteristics and overall satisfaction with the procedure were also recorded. Providers answered questions about cystoscopic visualization, ease of procedure, and perception of participant comfort. Prespecified noninferiority margin was set to equal the anticipated minimum clinically important difference of 14 mm. A planned sample of 100 participants, 50 in each treatment arm, provided 80% power to detect noninferiority at a significance level of.05. We performed a modified intention-to-treat analysis and compared variables with the t test or the Fisher exact test. RESULTS: A total of 111 participants were enrolled, and complete data were obtained for 100 participants; 47 participants were randomized to phenazopyridine and 53 to lidocaine. Baseline characteristics did not differ between groups. There were 19.6% and 20.8% of participants in the phenazopyridine and lidocaine groups, respectively, who previously underwent intradetrusor onabotulinumtoxinA injections. The mean postprocedure pain was 2.7 mm lower in the phenazopyridine group than in the lidocaine group (95% confidence interval, -11.3 to 10.7), demonstrating noninferiority. More than 90% of participants in both groups stated that the pain was tolerable. Slightly more participants reported being "very satisfied" in the lidocaine group, although this was not statistically significant (50.0% vs 40.4%; P=.34). Providers reported clear visualization in 89.4% of participants in the phenazopyridine group and in 100% of participants in the lidocaine group (P=.02). Provider perception of participant comfort and overall ease of procedure were not different between groups. Length of time in the exam room was significantly shorter in the phenazopyridine than in the lidocaine group (44.4 vs 57.5 minutes; P=.0003). CONCLUSION: In women receiving intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder, oral phenazopyridine was noninferior to intravesical lidocaine for procedural pain control. Phenazopyridine is well-tolerated by participants, allows for the procedure to be performed with similar ease, and is associated with shorter appointment times.

Overactive bladder medication prescription trends from 2014 to 2018.

PURPOSE: A growing literature points to an association between overactive bladder (OAB) medications and dementia. Given differences in side effects for extended-release (ER) and immediate-release (IR) anticholinergic formulations and beta-3 agonists, we examined prescription utilization patterns in a national dataset of older adults from 2014 to 2018. METHODS: We performed a retrospective study using the Medicare Part D Drug Spending Dashboard, a publicly available database that includes data from outpatient pharmacy claims from 2014 to 2018 in the United States. We identified total claims and total spending on common OAB medications, and further assessed trends by anticholinergic burden by medication, and immediate and ER formulations. RESULTS: There were 54.1 million claims for OAB medications, accounting for $10.1 billion (2018 United States dollars) in spending from 2014 to 2018. When considering beta-agonist, mirabegron accounted for 13.1% of total claims and 29.0% of total spending. Mirabegron accounted for a greater proportion of OAB medication claims and spending during the 5 years from 5.7% to 20.1% and 11.3% to 44%, respectively. IR anticholinergics accounted for fewer total claims over this period, from 58.5% to 42.6%. ER formulations increased in proportion of all OAB medication total claims from 35.8% to 37.5% from 2014 to 2016, and decreased to 37.3% by 2018. CONCLUSION: OAB medications and expenditures increased from 2014 to 2018. Mirabegron accounted for higher proportions and IR-formulations for decreased proportions of each from 2014 to 2018. The impact on clinical outcomes is a key area for future investigation considering our findings.

Family planning in carriers of BRCA1 and BRCA2 pathogenic variants.

BRCA1 and BRCA2 pathogenic variant carriers have a high lifetime risk of developing breast and ovarian malignancies. Given the risks and significant ramifications of undergoing risk-reducing surgeries, many pathogenic variant carriers unaffected by cancer (previvors) struggle with family planning and reproductive decision making. The objective of this study was to determine the attitudes and practices of BRCA1 and BRCA2 pathogenic variant carriers with respect to family planning decision making. A cross-sectional survey was conducted of BRCA1 and BRCA2 previvors at four Northeastern medical centers. The survey was administered electronically via email using REDCap. The survey included demographic information as well as questions about genetic testing, prophylactic surgeries, family planning, and partnering. Data were analyzed with Fisher's exact tests and t tests. The survey was completed by 139 of 422 BRCA1 and BRCA2 pathogenic variant carriers (response rate 33%). Thirteen were excluded from analysis due to self-reported cancer history. Of the remaining 126, 21 (16.7%) were male and 105 (83.3%) were female. Female participants <35 years old at the time of genetic testing were significantly more likely than those 35 or greater to report feeling urgency to have a family after finding out about their BRCA1 and BRCA2 pathogenic variant (p < 0.0001). Younger women also reported their genetic status had a stronger impact on their romantic relationships (p = 0.029). Men were significantly more likely to report that they felt no urgency to have a family compared to women (p < 0.0001). Our study reflects the complex decision making for previvors and the intricacies of family planning in this population. Providers can use this knowledge as a guide to counsel patients about reproductive options.

Cervical Cancer Prevention: Screening Among Undocumented Hispanic Women Compared With Documented Hispanic Women.

OBJECTIVE: This study compared cervical cancer knowledge, screening practices, and barriers to screening among undocumented and documented Hispanic women. MATERIALS AND METHODS: An anonymous cross-sectional survey was administered to self-identifying Hispanic women older than 21 years at community-based clinics and health care-focused community sites in Rhode Island. The survey included demographics, immigration status, questions related to cervical cancer knowledge, screening practices, and barriers to screening. Participants were stratified based on their immigration status. Categorical variables were compared by χ2 or Fisher exact test. Knowledge scores and the number of barriers were compared by t test and Wilcoxon rank sum test, respectively. p values of less than .05 were considered statistically significant. RESULTS: Seventy-three undocumented women and 70 documented women were enrolled. Undocumented women had a significantly lower mean cervical cancer knowledge score (3.53, SD =1.97) compared with documented women (4.43, SD = 2.04; p = .0085) and also experienced more barriers to having cervical cytology or a human papillomavirus test (p = .001). Eighty-eight percent of the undocumented women and 47% of the documented women did not have health insurance (p < .0001). Sixty-two percent of the undocumented women felt that their lack of documentation was a barrier to cervical cancer screening. Fifty percent of the undocumented and 47% of the documented women had never heard of the human papillomavirus vaccine. CONCLUSIONS: Undocumented women have significantly lower mean cervical cancer knowledge scores compared with documented women. A lack of legal documentation is a significant barrier to cervical cancer screening among Hispanic women. Challenges inherent to being undocumented may contribute to women's lower knowledge scores and more pronounced barriers.

Variability in gynecologic case volume of obstetrician-gynecologist residents graduating from 2009 to 2017.

BACKGROUND: Residency training in obstetrics-gynecology has changed significantly over time, with residents expected to master an increasing number of surgical procedures. Residency operative case logs are tracked by the Accreditation Council for Graduate Medical Education, which sets case minimums for all procedures. In 2018, the Accreditation Council for Graduate Medical Education created a combined minimally invasive hysterectomy category and now requires graduating residents to complete a minimum of 70 minimally invasive hysterectomies. OBJECTIVES: The objectiges of the study were to evaluate the range of operative gynecological experience across graduating obstetrician-gynecologist residents in the United States and to estimate the number of residents able to meet new Accreditation Council for Graduate Medical Education minimum hysterectomy cases. STUDY DESIGN: Accreditation Council for Graduate Medical Education surgical case logs of graduating obstetrician-gynecologist residents from 2009 to 2017 were analyzed for case volume trends. RESULTS: The average total number of gynecological cases per resident decreased from 438.2 to 431.5 (P < .0001). Minimally invasive hysterectomy averages increased from 43.6 to 69.3 (P < .0001), a trend driven principally by an increase in total laparoscopic hysterectomies. Mean case log decreases were noted in invasive cancer (70.7 to 54.3), incontinence and pelvic floor (85.6 to 56.7), and total abdominal hysterectomies (74.4 to 42.9); (P < .0001 for all). Mean increases were seen in total laparoscopic (118.8 to 146.3) and operative hysteroscopy (68.6 to 77.1) cases (P < .0001 for all). The ratio of the 90th percentile to the 10th percentile of resident case logs showed substantial variation in surgical volume for all procedures, although this ratio decreased over time. Graduates who logged 70 minimally invasive hysterectomy cases were estimated to fall at the 51st percentile in 2017; this was down from the 91st percentile in 2009. CONCLUSION: Nationwide, graduates of obstetrician-gynecologist residency experience significant variability in their surgical training. Based on our extrapolation of Accreditation Council for Graduate Medical Education data, approximately half of residency graduates fell below the 70 case minimally invasive hysterectomy minimum in 2017. Meeting the new Accreditation Council for Graduate Medical Education hysterectomy minimums may be challenging for a significant proportion of residency programs. Understanding the scope and variability of gynecology training is needed to continue to improve and address gaps in resident education.

Identifying cardiovascular severe maternal morbidity in epidemiologic studies.

BACKGROUND: Cardiovascular severe maternal morbidity (CSMM) is rising and has become the leading cause of maternal mortality. Research using administrative data sets may allow for better understanding of this critical group of diseases. OBJECTIVE: To validate a composite variable of CSMM for use in epidemiologic studies. METHODS: We analysed delivery hospitalisations at an obstetric teaching hospital from 2007 to 2017. We utilised a subset of indicators developed by the Centers for Disease Control and Prevention based on ICD codes to form the composite variable for CSMM. Two expert clinicians manually reviewed all qualifying events using a standardised tool to determine whether these represented true CSMM events. Additionally, we estimated the number of CSMM cases among delivery hospitalisations without qualifying ICD codes by manually reviewing all hospitalisations with severe preeclampsia, a population at high risk of CSMM, and a random sample of 1000 hospitalisations without severe preeclampsia. We estimated validity of the composite variable. RESULTS: Among 91 355 admissions for delivery, we captured 113 potential CSMM cases using qualifying ICD codes. Of these, 65 (57.5%) were true CSMM cases. Indicators for acute myocardial infarction, cardiac arrest, and cardioversion had the highest true-positive rates (100% for all). We found an additional 70 CSMM cases in the 2102 admissions with severe preeclampsia and a single CSMM case in the random sample. Assuming a rate of 1 CSMM case per 1000 deliveries in the remaining cohort, the composite variable had a positive predictive value of 57.5% (95% CI 47,9, 66.8), a negative predictive value of 99.8% (95% CI 99.8, 99.9), a sensitivity of 29.0% (95% CI 23.2, 35.4), and a specificity of 100% (95% CI 99.9, 100.0). CONCLUSION: A novel composite variable for CSMM had reasonable PPV but limited sensitivity. This composite variable may enable epidemiologic studies geared towards reducing maternal morbidity and mortality.

Provider miscategorization of frailty in an outpatient urogynecologic population.

INTRODUCTION AND HYPOTHESIS: Routine assessment of frailty preoperatively is recommended for older adults, because frailty is associated with adverse surgical outcomes. This study was aimed at describing the percentage of patients whose frailty status was correctly categorized by Female Pelvic Medicine and Reconstructive Surgery (FPRMS) providers and to determine patient predictors of accurate categorization. METHODS: Cross-sectional study was carried out of English speaking, new patients, >65 years old, presenting from March to June 2018. Providers categorized patients as frail, pre-frail, or not frail based on clinical impression. Frailty was defined using the Fried Frailty Assessment (FFA), a validated, objective measure including weight loss, exhaustion, physical activity, walk speed, and grip strength. Provider categorizations were compared with FFA results. Multiple logistic regression was used to estimate patient predictors of frailty categorization. Data from other fields that approximated a 45% proportion of miscategorization guided sample size estimates. RESULTS: Ten FPMRS providers participated, and 106 out of 110 patients (96%) had complete data. Primary diagnoses were pelvic organ prolapse (37%), incontinence (20%), and overactive bladder (17%). On FFA, 16 (15%) patients were frail, 50 (47%) were pre-frail, and 40 (38%) were not frail. The overall proportion of miscategorization was 58% (95% confidence interval 49-68%). Providers correctly categorized 50% of frail patients, 34% of pre-frail patients, and 48% of non-frail patients. Slow walk time was associated with provider categorization of frailty, regardless of frailty status (p = 0.01). CONCLUSIONS: Clinical impression may not adequately assess frailty. Miscategorization of frailty by FPMRS providers was higher than in other fields.

Perioperative peer support and surgical preparedness in women undergoing reconstructive pelvic surgery.

INTRODUCTION AND HYPOTHESIS: The benefits of peer support for pelvic floor disorders are unclear. We hypothesize that perioperative peer support might be associated with greater preoperative preparedness compared with usual care in women undergoing pelvic reconstruction. METHODS: A multicenter prospective cohort study of women undergoing pelvic reconstruction compared peer support (group or one-to-one) with usual care. The primary outcome was preparedness, measured by a Preoperative Preparedness Questionnaire at baseline and before surgery. Assuming 48% preparedness in usual care preoperatively, 44 women per group (Group, One-to-One, or Usual care) would detect a 30% difference in preparedness (alpha = 0.05, 80% power). Chi-squared or Fisher's exact test compared categorical variables, t test and analysis of variance compared continuous variables, independent sample tests compared changes in mean or composite scores, and multiple logistic regression estimated the effect. RESULTS: One hundred and sixty-eight patients were included (113 with peer support, 55 undergoing usual care). A greater proportion of women in peer support had college or higher education versus usual care (78 vs 58%, P = 0.02). After the intervention, the proportion of women feeling prepared was not different between groups (66 vs 63%, P = 0.9). However, a greater proportion in peer support reported improved preparedness from baseline compared with usual care (71 vs 44%, P = 0.001). Peer support was associated with improved preparedness on multiple regression adjusting for age, study site, education, and surgery type (OR 4.14, 95% CI 1.69, 10.14). CONCLUSION: Peer support was associated with improved preoperative preparedness compared with usual care, but did not result in a greater proportion of women feeling prepared before surgery.

The Association Between Mindfulness and Postoperative Pain: A Prospective Cohort Study of Gynecologic Oncology Patients Undergoing Minimally Invasive Hysterectomy.

STUDY OBJECTIVE: To describe the association between preoperative dispositional mindfulness (the personality trait of being mindful) and postoperative pain in gynecologic oncology patients undergoing minimally invasive hysterectomy. DESIGN: Prospective cohort study. SETTING: University-affiliated teaching hospital. PATIENTS: Gynecologic oncology patients (n = 126) planning minimally invasive hysterectomy. INTERVENTIONS: Minimally invasive hysterectomy. MEASUREMENTS AND MAIN RESULTS: Baseline mindfulness was assessed at the preoperative visit using the Five Facet Mindfulness Questionnaire (FFMQ). Postoperative pain and opioid usage were evaluated via chart review and surveys at postoperative visits at 1 to 2 weeks and 4 to 6 weeks. Higher baseline mindfulness was correlated with lower postoperative pain as measured by both the average and highest numeric pain scores during the inpatient stay (r = -.23, p = .020; r = -.21, p = .034). At the initial postoperative visit, pain score was also inversely correlated with preoperative mindfulness score (r = -.26, p = .008). This relationship was not observed at the final postoperative visit (r = -.08, p = .406). Pre-operative mindfulness and opioid usage were also inversely associated, though this relationship did not reach statistical significance (r = -.18, p = .066). CONCLUSION: Mindfulness was previously shown to be a promising intervention for chronic pain treatment. Our study demonstrates that higher preoperative dispositional mindfulness is associated with more favorable postoperative pain outcomes, including lower pain scores but not lower opioid consumption. This relationship provides an opportunity to target the modifiable personality characteristic of mindfulness, to reduce postoperative pain in patients following gynecologic surgery.

Sexual Dysfunction in Survivorship; the Impact of Menopause and Endocrine Therapy.

BACKGROUND: Sexual dysfunction is common for breast cancer survivors. Premenopausal women with breast cancer are increasingly offered ovarian suppression and aromatase inhibitor (AI) therapy. We evaluated the association of menopausal status and treatment modalities on sexual dysfunction. METHODS: We conducted a cross-sectional anonymous Female Sexual Function Index (FSFI) survey of breast cancer survivors between 2000 and 2016. Analysis utilized Kruskal-Wallis test for FSFI scores, Chi square, or Fisher's exact test for categorical data, and regression analysis for associations. RESULTS: Of 585 respondents, 278 (47.5%) had complete FSFI scores. Of these, 24 (8.6%) were premenopausal and 80 (28.8%) were pre/perimenopausal at survey completion. Median FSFI scores for premenopausal (31.2, interquartile range [IQR] 26.8-33.6) and pre/perimenopausal (29.2, IQR 25.9-32.2) were similar, whereas postmenopausal women (25.9, IQR 21.0-30.3) were significantly lower (p = 0.0007 and p = 0.0002, respectively). Premenopausal women were less likely to meet criteria for sexual dysfunction (FSFI score ≤ 26.55) than postmenopausal women (21 versus 55%, p < 0.0001, univariate analysis [odds ratio (OR) 0.32, 95% confidence interval (CI) 0.18-0.56]). Adjusting for treatment modality did not impact the significance (OR 0.43, 95% [CI] 0.23-0.80) but revealed that AIs independently are associated with sexual dysfunction (OR 2.41, 95% CI 1.32-4.40). The interaction between menopausal status and AIs was not significant (p = 0.24). CONCLUSIONS: Our study demonstrates that menopausal status is associated with sexual dysfunction in breast cancer patients and sexual dysfunction in premenopausal women is not impacted by treatment modality outside of aromatase inhibitor therapy. As more premenopausal patients are treated with ovarian suppression, these data may guide clinicians in counseling patients regarding sexual dysfunction expectations.

Opioid use after minimally invasive hysterectomy in gynecologic oncology patients.

OBJECTIVES: To quantify, and identify predictors of, post-discharge opioid use in gynecologic oncology patients undergoing minimally invasive hysterectomy (MIH). METHODS: For this prospective cohort study, gynecologic oncology patients planning to undergo MIH were recruited at a single institution. Post-operative opioid usage was evaluated via chart review and surveys at 1-2-week and 4-6-week post-operative visits. Opioids are converted to oral morphine milligram equivalents (MME) for standardization. Descriptive statistics and modified Poisson regression were used to quantify opioid requirements and evaluate predictors of post-discharge opioid use respectively. RESULTS: One hundred eighteen eligible women underwent MIH. Of these, 108 had complete data at both follow-up timepoints. Malignancy was present in 79% of cases, 71% of which were endometrial cancer. Most surgeries were laparoscopic (73%). Median hospital stay was 1 night (IQR 1-1). Inpatients received a median of 30.75 MME (IQR 7.5-52.5 MME). Twenty-three women (21.3%) used no opioids while inpatient. At the 1-2-week follow-up median usage was 6 pills of 5 mg oxycodone, or 45 MME (IQR 0-15.5 pills). After complete follow-up, median post-discharge usage was 10 pills, or 75 MME (IQR 0-22.5 pills) and 36 participants (33.33%) used no opioids after hospital discharge. The median prescription was for 30 pills (range 10-60). Above median inpatient opioid use was associated with an increased risk of above median opioid usage after hospital discharge (RR 2.31, 95% CI 1.38-3.87) on multivariable analysis. CONCLUSIONS: In this cohort, opioids were overprescribed relative to use. Inpatient use was the strongest predictor of post-discharge opioid use. More restrictive, and personalized, opioid prescribing practices may be a pathway to reduce opioid misuse and diversion. PRéCIS: Opioids were overprescribed by a factor of three to gynecologic oncology patients, whose inpatient opioid requirement predicted post-discharge opioid needs after minimally invasive hysterectomy.