Prophylactic Unfractionated Heparin in Antepartum Hospitalizations: A Randomized Controlled Trial.

OBJECTIVE: To assess the effect of gestational age-based dosing of unfractionated heparin (UFH) compared with standard dosing of UFH for thromboprophylaxis on an elevated serum activated partial thromboplastin time (aPTT) during prolonged antepartum hospitalizations. METHODS: This was a randomized trial of pregnant persons who were admitted in the antepartum period for at least 72 hours. Participants were randomly allocated to the standard dose of UFH (5,000 units subcutaneously every 12 hours) or the gestational age-based dose of UFH (first trimester [less than 14 weeks]: 5,000 units subcutaneously every 12 hours; second trimester [14-27 6/7 weeks]: 7,500 units subcutaneously every 12 hours; third trimester (28 weeks or more): 10,000 units subcutaneously every 12 hours). The primary outcome was the proportion of antepartum patients who had an elevated serum aPTT value above the normal range (more than 36.2 seconds) 6 hours after an UFH dose. Secondary outcomes included the development of venous thromboembolism (VTE) and reported side effects of heparin administration. RESULTS: Between December 15, 2020, and April 1, 2022, 97 patients with antepartum hospitalizations were screened and 46 were randomized: 22 allocated to standard dosing and 24 allocated to gestational age-based dosing of UFH. A significantly greater proportion of antepartum patients who received gestational age-based dosing had an abnormal elevation in aPTT compared with those who received standard dosing (33.3% vs 4.8%, P=.02). Gestational age-based dosing resulted in higher maximum [interquartile range] aPTT (30.4 [27.4, 37.5] vs 26.6 [23.0, 29.6], P=.01) and anti-Xa levels (0.09 [0.09, 0.11] vs 0.09 [0.09, 0.09], P=.04). There was no significant difference in VTE between groups (P=.47). CONCLUSION: Gestational age-based dosing of UFH for thromboprophylaxis of antepartum hospitalizations was associated with significantly increased rates of elevated coagulation parameters compared with standard fixed dosing. This study suggests a need for close monitoring if higher doses of UFH during pregnancy are used later in gestation. The efficacy of gestational age-based dosing compared with standard dosing for UFH to prevent thromboembolic events remains an area for future investigation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04635839.

Impact of Gabapentin on Postoperative Hypotension in Enhanced Recovery after Surgery Protocols for Microvascular Breast Reconstruction.

Background: Enhanced recovery after surgery (ERAS) protocols have been associated with hypotensive episodes after autologous breast reconstruction. Gabapentin (Gaba), a nonopioid analgesic used in ERAS, has been shown to attenuate postoperative hemodynamic responses. This study assesses ERAS's impact, with and without Gaba, on postoperative hypotension after microvascular breast reconstruction. Methods: Three cohorts were studied: traditional pathway, ERAS + Gaba, and ERAS no-Gaba. We evaluated length of stay, inpatient narcotic use [morphine milligram equivalents (MME)], mean systolic blood pressure, hypotension incidence, and complications. The traditional cohort was retrospectively reviewed, whereas the ERAS groups were enrolled prospectively after the initiation of the protocol in April 2019 (inclusive of Gaba until October 2022). Results: In total, 441 patients were analyzed. The three cohorts, in the order mentioned above, were similar in age and bilateral reconstruction rates (57% versus 61% versus 60%). The ERAS cohorts, both with and without Gaba, had shorter stays (P < 0.01). Inpatient MME was significantly less in the ERAS + Gaba cohort than the traditional or ERAS no-Gaba cohorts (medians: 112 versus 178 versus 158 MME, P < 0.01). ERAS + Gaba significantly increased postoperative hypotensive events on postoperative day (POD) 1 and 2, with notable reduction after Gaba removal (P < 0.05). Across PODs 0-2, mean systolic blood pressure was highest in the traditional cohort, followed by ERAS no-Gaba, then the ERAS + Gaba cohort (P < 0.05). Complication rates were similar across all cohorts. Conclusions: Postmicrovascular breast reconstruction, ERAS + Gaba reduced overall inpatient narcotic usage, but increased hypotension incidence. Gaba removal from the ERAS protocol reduced postoperative hypotension incidence while maintaining similar stay lengths and complication rates.

Determination of Whole Blood Loss From Minimally Invasive Myomectomy Using a Standardized Formula: A Pilot Study.

STUDY OBJECTIVE: To determine the median perioperative blood loss (PBL) during minimally invasive surgical (MIS) myomectomy. DESIGN: Prospective pilot study. SETTING: Large academic teaching hospital. PATIENTS: Thirty-one patients underwent laparoscopic or robotic myomectomy and completed a postoperative complete blood count (CBC) from November 2020 to August 2022. Patients had to have at least one fibroid greater than or equal to 3 cm on preoperative imaging. INTERVENTIONS: A CBC was collected preoperatively within 7 days of surgery. Estimated blood loss (EBL) was determined by the surgeon intraoperatively. A repeat CBC was drawn between postoperative days 2 through 4. PBL was calculated using the equation PBL = (patient weight in kg × 65 cc/kg) × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit. MEASUREMENTS AND MAIN RESULTS: Median PBL (536.3 cc [270.0, 909.3]) was greater than median EBL (200.0 cc [75.0, 500.0]). PBL ranged from a net gain of 191.5 cc to net loss of 2362.5 cc. Median size of the largest fibroid on preoperative imaging was 8.8 cm (6.6, 11.5), and median weight of fibroids removed was 321 g (115, 519). About half of patients (51.6%) had one fibroid removed, and 48.4% had 2 or more fibroids removed. Five patients were converted to laparotomy, 4 from robotic approaches. Two patients required a blood transfusion. CONCLUSION: Calculated PBL was greater than intraoperative EBL. This suggests there is continued blood loss post myometrial bed closure. Blood loss should be evaluated both during and after myomectomy, as intraoperative EBL underestimates total PBL.

Neighborhood Deprivation, Race and Ethnicity, and Prostate Cancer Outcomes Across California Health Care Systems.

Importance: Non-Hispanic Black (hereafter, Black) individuals experience worse prostate cancer outcomes due to socioeconomic and racial inequities of access to care. Few studies have empirically evaluated these disparities across different health care systems. Objective: To describe the racial and ethnic and neighborhood socioeconomic status (nSES) disparities among residents of the same communities who receive prostate cancer care in the US Department of Veterans Affairs (VA) health care system vs other settings. Design, Setting, and Participants: This cohort study obtained data from the VA Central Cancer Registry for veterans with prostate cancer who received care within the VA Greater Los Angeles Healthcare System (VA cohort) and from the California Cancer Registry (CCR) for nonveterans who received care outside the VA setting (CCR cohort). The cohorts consisted of all males with incident prostate cancer who were living within the same US Census tracts. These individuals received care between 2000 and 2018 and were followed up until death from any cause or censoring on December 31, 2018. Data analyses were conducted between September 2022 and December 2023. Exposures: Health care setting, self-identified race and ethnicity (SIRE), and nSES. Main Outcomes and Measures: The primary outcome was all-cause mortality (ACM). Cox proportional hazards regression models were used to estimate hazard ratios for associations of SIRE and nSES with prostate cancer outcomes in the VA and CCR cohorts. Results: Included in the analysis were 49 461 males with prostate cancer. Of these, 1881 males were in the VA cohort (mean [SD] age, 65.3 [7.7] years; 833 Black individuals [44.3%], 694 non-Hispanic White [hereafter, White] individuals [36.9%], and 354 individuals [18.8%] of other or unknown race). A total of 47 580 individuals were in the CCR cohort (mean [SD] age, 67.0 [9.6] years; 8183 Black individuals [17.2%], 26 206 White individuals [55.1%], and 13 191 individuals [27.8%] of other or unknown race). In the VA cohort, there were no racial disparities observed for metastasis, ACM, or prostate cancer-specific mortality (PCSM). However, in the CCR cohort, the racial disparities were observed for metastasis (adjusted odds ratio [AOR], 1.36; 95% CI, 1.22-1.52), ACM (adjusted hazard ratio [AHR], 1.13; 95% CI, 1.04-1.24), and PCSM (AHR, 1.15; 95% CI, 1.05-1.25). Heterogeneity was observed for the racial disparity in ACM in the VA vs CCR cohorts (AHR, 0.90 [95% CI, 0.76-1.06] vs 1.13 [95% CI, 1.04-1.24]; P = .01). No evidence of nSES disparities was observed for any prostate cancer outcomes in the VA cohort. However, in the CCR cohort, heterogeneity was observed for nSES disparities with ACM (AHR, 0.82; 95% CI, 0.80-0.84; P = .002) and PCSM (AHR, 0.86; 95% CI, 0.82-0.89; P = .007). Conclusions and Relevance: Results of this study suggest that racial and nSES disparities were wider among patients seeking care outside of the VA health care system. Health systems-related interventions that address access barriers may mitigate racial and socioeconomic disparities in prostate cancer.

Impact of mastectomy flap necrosis on prepectoral reconstructive outcomes.

INTRODUCTION: As reconstructive surgeons have increasingly transitioned to the prepectoral plane for prosthetic breast reconstruction, the implications of mastectomy skin flap necrosis have become more concerning. Our goal was to evaluate the effect of skin flap necrosis on reconstructive outcomes in patients undergoing immediate prepectoral breast reconstruction. METHODS: A retrospective review was conducted of patients undergoing immediate two-stage prepectoral reconstruction at a single center with at least 3 months follow-up. Postoperative complications, reconstructive outcome, and time to final implant were compared between patients with and without mastectomy skin necrosis. RESULTS: A total of 301 patients underwent 509 prepectoral breast reconstructions. Forty-four patients (14.6%) experienced postoperative mastectomy skin flap necrosis. Demographic and reconstructive characteristics were similar between the necrosis and no necrosis cohorts. Patients with skin necrosis were more likely to undergo reoperation after tissue expander (64% vs 19%, p < 0.01) and undergo expander replacement (13.6% vs 3.5%, p = 0.02). However, rates of reconstructive failure (6.8% vs 6.2%), major infection (9.1% vs 9.0%), and minor infection (13.6% vs 17.5%) after expander placement were statistically similar. Patients with skin necrosis trended toward longer time before final implant placement, although the difference was not statistically significant (6.5 vs 5.0 months, p = 0.08). There was no difference in complication rates between the necrosis and no necrosis cohort after final implant placement. There was a higher rate of revision surgery after implant placement in the necrosis cohort (12.5% vs 4.1%, p = 0.047). CONCLUSIONS: Mastectomy skin flap necrosis is a concerning postoperative event, particularly in patients with prepectoral prostheses. We observed that patients with skin necrosis experience higher reoperation rates in the expander period, yet have similar infection rates and achieve similar final reconstructive outcomes compared to patients without necrosis.

Gender-Affirming Mastectomy: Psychosocial and Surgical Outcomes in Transgender Adults.

BACKGROUND: Limited literature exists examining the effects of gender-affirming mastectomy on transmasculine and nonbinary patients that is prospective and uses validated survey instruments. STUDY DESIGN: The psychosocial functioning of transmasculine and nonbinary patients was compared between patients who underwent gender-affirming mastectomy and those who had not yet undergone surgery. Participants were enrolled in a single-site, combined study of surgical and psychosocial outcomes, including a cross-sectional cohort of preoperative and postoperative patients, as well as separate prospective cohort. Participants completed the BREAST-Q psychosocial and sexual well-being modules, the BODY-Q satisfaction with chest and nipples modules, the Body Image Quality of Life Inventory, the Transgender Congruence Scale, the Patient Health Questionnaire-9, and the Generalized Anxiety Disorder-7 scale before and after surgery. We also examined how patient demographic factors correlated with postoperative surgical and psychosocial outcomes. RESULTS: A total of 111 transmasculine and nonbinary patients 18 to 63 years of age (mean ± SD 26.5 ± 8) underwent mastectomy and were included in the study. All were included in the cross-sectional cohort, and 20 were enrolled in the prospective cohort. More than one-third (34.2%) of patients were nonbinary. After surgery, psychosocial and sexual well-being, satisfaction, body image-related quality of life, and gender congruence were increased (p < 0.001) in both cohorts, and depression (p < 0.009 cross-sectional), and anxiety (p < 0.001 cross-sectional) were decreased. The most common adverse event was hypertrophic scarring, which occurred in 41 (36.9%) participants. CONCLUSIONS: In this study of transmasculine and nonbinary adults, gender-affirming mastectomy was followed by substantial improvements in psychosocial functioning.

Enhanced Recovery after Surgery Protocol Decreases Length of Stay and Postoperative Narcotic Use in Microvascular Breast Reconstruction.

Background: Enhanced recovery after surgery (ERAS) protocols have demonstrated efficacy following microvascular breast reconstruction. This study assesses the impact of an ERAS protocol following microvascular breast reconstruction at a high-volume center. Methods: The ERAS protocol introduced preoperative counseling, multimodal analgesia, early diet resumption, and early mobilization to our microvascular breast reconstruction procedures. Data, including length of stay, body mass index, inpatient narcotic use, outpatient narcotic prescriptions, inpatient pain scores, and complications, were prospectively collected for all patients undergoing microvascular breast reconstruction between April 2019 and July 2021. Traditional pathway patients who underwent reconstruction immediately before ERAS implementation were retrospectively reviewed as controls. Results: The study included 200 patients, 99 in traditional versus 101 in ERAS. Groups were similar in body mass index, age (median age: traditional, 54.0 versus ERAS, 50.0) and bilateral reconstruction rates (59.6% versus 61.4%). ERAS patients had significantly shorter lengths of stay, with 96.0% being discharged by postoperative day (POD) 3, and 88.9% of the traditional cohort were discharged on POD 4 (P < 0.0001). Inpatient milligram morphine equivalents (MMEs) were smaller by 54.3% in the ERAS cohort (median MME: 154.2 versus 70.4, P < 0.0001). Additionally, ERAS patients were prescribed significantly fewer narcotics upon discharge (median MME: 337.5 versus 150.0, P < 0.0001). ERAS had a lower pain average on POD 0-3; however, this finding was not statistically significant. Conclusion: Implementing an ERAS protocol at a high-volume microvascular breast reconstruction center reduced length of stay and postoperative narcotic usage, without increasing pain or perioperative complications.

Health System Perspective on Cost for Delivering a Decision Aid for Prostate Cancer Using Time-driven Activity-based Costing.

BACKGROUND: Previsit decision aids (DAs) have promising outcomes in improving decisional quality, however, the cost to deploy a DA is not well defined, presenting a possible barrier to health system adoption. OBJECTIVES: We aimed to define the cost from a health system perspective of delivery of a DA. RESEARCH DESIGN: Observational cohort. PATIENTS AND METHODS: We interviewed or observed relevant personnel at 3 institutions with implemented DA distribution programs targeting men with prostate cancer. We then created process maps for DA delivery based on interview data. Cost determination was performed utilizing time-driven activity-based costing. Clinic visit length was measured on a subset of patients. Decisional quality measures were collected after the clinic visit. RESULTS: Total process time (minutes) for DA delivery was 10.14 (UCLA), 68 (Olive View-UCLA), and 25 (Vanderbilt). Total average costs (USD) per patient were $38.32 (UCLA), $59.96 (Olive View-UCLA), and $42.38 (Vanderbilt), respectively. Labor costs were the largest contributors to the cost of DA delivery. Variance analyses confirmed the cost efficiency of electronic health record (EHR) integration. We noted a shortening of clinic visit length when the DA was used, with high levels of decision quality. CONCLUSIONS: Time-driven activity-based costing is an effective approach to determining true inclusive costs of service delivery while also elucidating opportunities for cost containment. The absolute cost of delivering a DA to men with prostate cancer in various settings is much lower than the system costs of the treatments they consider. EHR integration streamlines DA delivery efficiency and results in substantial cost savings.

The nature of embryonic mosaicism across female age spectrum: an analysis of 21,345 preimplantation genetic testing for aneuploidy cycles.

Objective: To understand how mosaicism varies across patient-specific variables and clinics. Design: Cross-sectional cohort. Setting: Genetic testing laboratory. Patients: A total of 86,208 embryos from 17,366 patients underwent preimplantation genetic testing for aneuploidy using next-generation sequencing. Interventions: Mosaic embryos were classified as either low-level (20%-40%) or high-level (40%-80%) and by type of mosaic error: single segmental, complex segmental, single chromosome, or complex abnormal mosaic. The rate of mosaicism was stratified by the Society for Assisted Reproductive Technology age categories: <35 years, 35-37 years, 38-40 years, 41-42 years, and >42 years. Main Outcome Measures: Distribution of chromosomal findings and prevalence of mosaicism type by age. Probability of creating mosaic embryos in a subsequent cycle. Results: Among all embryos, 44% were euploid, 40.2% were aneuploid, and 15.8% were mosaic. Both low-level and high-level mosaicism were more prevalent among younger patients. Of all mosaic embryos, the youngest age cohort <35 years had the highest proportions of single and complex segmental mosaicism (37.9% and 6.8%, respectively), whereas those aged >42 years had the highest single whole chromosome and complex abnormal mosaicism (37.1% and 34.0%, respectively). Although there was variability in mosaic rates across clinics, the median mosaic rate over 3 years ranged from 14.48% to 17.72%. A diagnosis of a mosaic embryo in a previous cycle did not increase a patient's odds for having a mosaic embryo in a subsequent cycle. Conclusions: Mosaicism is overall higher in younger patients, but the complexity of mosaic errors increases with age. A history of mosaicism was not associated with mosaicism in subsequent cycles. Additional research is needed to understand the etiologies of the various subtypes of mosaic embryos and clinical outcomes associated with their transfer.

Utility of Magnetic Resonance Imaging for Localizing Prostate Cancer Near the Urethra in Men Who Are Candidates for Focal Gland Ablation.

PURPOSE: Given that treatment near the urethra is often limited to reduce side effects, in this study we aim to determine whether prostate MRI can accurately identify the distance of prostate cancer to the urethra in a cohort of men who were potential candidates for focal gland ablation. MATERIALS AND METHODS: A single-institution analysis was performed of men who underwent MRI, targeted biopsy, and radical prostatectomy from July 2012 to April 2021. Men who were candidates for focal gland ablation were identified. The ability of MRI to identify prostate cancer within 5 mm of the prostatic urethra as confirmed on whole-mount pathology was assessed. Multivariate regression was utilized to determine characteristics associated with prostate cancer within 5 mm of the urethra on whole-mount pathology. RESULTS: In 48 out of 67 men (72%), the tumor was within 5 mm of the urethra on whole-mount pathology. MRI was concordant with whole-mount pathology in 49 out of 67 men (73%). The sensitivity of MRI for identifying cancer within 5 mm of the urethra was 77% (65%-89%) and the specificity was 63% (42%-89%). The positive predictive value was 84% (range 73%-95%) and negative predictive value was 52% (32%-73%). In adjusted analysis, PSA density and Prostate Imaging-Reporting and Data System were not significantly associated with having prostate cancer within close proximity of the urethra. CONCLUSIONS: A significant number of men who are potential candidates for focal gland ablation have cancer within close proximity to the urethra that could serve as a significant source of in-field recurrence. The sensitivity of MRI for identifying these lesions is 77% and can be used to further improve patient selection for focal gland ablation.

Cryotherapy for partial gland ablation of prostate cancer: Oncologic and safety outcomes.

BACKGROUND: Partial gland ablation (PGA) is a new option for treatment of prostate cancer (PCa). Cryotherapy, an early method of PGA, has had favorable evaluations, but few studies have employed a strict protocol using biopsy endpoints in men with clinically significant prostate cancer (csPCa). METHODS: 143 men with unilateral csPCa were enrolled in a prospective, observational trial of outpatient PGA-cryotherapy. Treatment was a 2-cycle freeze of the affected prostate part. Participants were evaluated with MRI-guided biopsy (MRGB) at baseline and at 6 months and 18 months after treatment. Absence of csPCa upon MRGB was the primary endpoint; quality-of-life at baseline and at 6 months after treatment was assessed by EPIC-CP questionnaires in the domains of urinary and sexual function. RESULTS: Of the 143 participants, 136 (95%) completed MRGB at 6 months after treatment. In 103/136 (76%), the biopsy revealed no csPCa. Of the 103, 71 subsequently had an 18-month comprehensive biopsy; of the 71 with 18-month biopsies, 46 (65%) were found to have no csPCa. MRI lesions became undetectable in 96/130 (74%); declines in median serum PSA levels (6.9 to 2.5 ng/mL), PSA density (0.15 to 0.07), and prostate volume (42 to 34cc) were observed (all p < 0.01). Neither lesion disappearance on MRI nor PSA decline correlated with biopsy outcome. Urinary function was affected only slightly and sexual function moderately. CONCLUSION: In the near to intermediate term, partial gland ablation with cryotherapy was found to be a safe and moderately effective treatment of intermediate-risk prostate cancer. Eradication of cancer was better determined by MRI-guided biopsy than by MRI or PSA.

Impact of Comprehensive Health Insurance on Quality of Life in Low-Income Hispanic Men with Prostate Cancer.

OBJECTIVE: To evaluate the effect of the transition from IMPACT, a disease-focused treatment program, to comprehensive health insurance under Medicaid through the Affordable Care Act (ACA) on general and prostate cancer-specific quality of life (QoL) on a cohort of previously uninsured low-income men. We hypothesize that general QoL would improve and prostate cancer-specific QoL would remain the same after the transition to comprehensive health insurance. METHODS: We assessed and compared general QoL using the RAND SF-12v2™ (12-Item Short Form Survey, version 2) and prostate cancer-specific QoL using the UCLA PCI (Prostate Cancer Index) one year before, at, and one year after the transition between 30 men who transitioned to comprehensive insurance (newly insured/Medicaid group) and 54 men who remained in the prostate cancer program (uninsured/IMPACT group). We assessed the independent effects of Medicaid coverage on QoL outcomes using repeated-measures regression. RESULTS: Our cohort was composed primarily of Hispanic men (82%). At transition, patient demographics and clinical characteristics were similar between the groups. General and prostate cancer-specific QoL did not differ between the groups and remained stable over time, Radical prostatectomy as primary treatment and shorter time since treatment were associated with worse urinary and sexual function across both groups and over all three time points. CONCLUSION: Those who transitioned to full-scope insurance and those who remained in the free prostate cancer-focused treatment program had stable general and prostate cancer-specific QoL. High-touch navigation aspects of a disease-focused program may have contributed to stability in outcomes.

Intraoperative Laparoscopic Ultrasound Increases Fibroid Detection During Laparoscopic Myomectomy.

Objective: To assess the utility of intraoperative laparoscopic ultrasound in detecting additional fibroids during laparoscopic myomectomy (LM). Methods: Forty-two patients were enrolled in this prospective cohort study. All cases were performed by the same surgeon at a university affiliated hospital between April 1, 2019 and February 29, 2020. Following routine laparoscopic myomectomy, the laparoscopic ultrasound was then introduced, and ultrasonography was performed directly on the uterus. Any additional fibroids discovered were enucleated. Results: Using the laparoscopic ultrasound, an additional 54 fibroids among 27 (64%) of the 42 patients were found, with a median of 2 additional fibroids per patient (interquartile range [IQR] 1,3). Median fibroid size detected by laparoscopic ultrasound was 1.5 centimeters (IQR 1-3) and the most common types were FIGO grades 3 and 2 (43% and 33% respectively). The median surgical time was longer among patients in whom additional fibroids were found (170 minutes (IQR 137-219) vs 150 minutes (IQR 120-193), p = .044). When ≥ 2 fibroids were removed by usual methods, the laparoscopic ultrasound found additional fibroids 80% of the time, compared to 25% when < 2 fibroids were removed by usual methods (p < .001). Conclusion: Intraoperative laparoscopic ultrasonography is a useful tool in detecting additional fibroids that would have otherwise been missed. It is particularly helpful in identifying smaller intramural fibroids and in patients with multiple fibroids. By detecting additional fibroids, laparoscopic ultrasonography can help maximize the effectiveness of laparoscopic myomectomy and help decrease the rates of residual fibroids.

Comprehension, utility, and preferences of prostate cancer survivors for visual timelines of patient-reported outcomes co-designed for limited graph literacy: meters and emojis over comics.

OBJECTIVE: Visual timelines of patient-reported outcomes (PRO) can help prostate cancer survivors manage longitudinal data, compare with population averages, and consider future trajectories. PRO visualizations are most effective when designed with deliberate consideration of users. Yet, graph literacy is often overlooked as a design constraint, particularly when users with limited graph literacy are not engaged in their development. We conducted user testing to assess comprehension, utility, and preference of longitudinal PRO visualizations designed for prostate cancer survivors with limited literacy. MATERIALS AND METHODS: Building upon our prior work co-designing longitudinal PRO visualizations with survivors, we engaged 18 prostate cancer survivors in a user study to assess 4 prototypes: Meter, Words, Comic, and Emoji. During remote sessions, we collected data on prototype comprehension (gist and verbatim), utility, and preference. RESULTS: Participants were aged 61-77 (M = 69), of whom half were African American. The majority of participants had less than a college degree (95%), had inadequate health literacy (78%), and low graph literacy (89%). Among the 4 prototypes, Meter had the best gist comprehension and was preferred. Emoji was also preferred, had the highest verbatim comprehension, and highest rated utility, including helpfulness, confidence, and satisfaction. Meter and Words both rated mid-range for utility, and Words scored lower than Emoji and Meter for comprehension. Comic had the poorest comprehension, lowest utility, and was least preferred. DISCUSSION: Findings identify design considerations for PRO visualizations, contributing to the knowledge base for visualization best practices. We describe our process to meaningfully engage patients from diverse and hard-to-reach groups for remote user testing, an important endeavor for health equity in biomedical informatics. CONCLUSION: Graph literacy is an important design consideration for PRO visualizations. Biomedical informatics researchers should be intentional in understanding user needs by involving diverse and representative individuals during development.

Delivery Timing and Associated Outcomes in Pregnancies With Maternal Congenital Heart Disease at Term.

Background Current recommendations for delivery timing of pregnant persons with congenital heart disease (CHD) are based on expert opinion. Justification for early-term birth is based on the theoretical concern of increased cardiovascular stress. The objective was to evaluate whether early-term birth with maternal CHD is associated with lower adverse maternal or neonatal outcomes. Methods and Results This is a retrospective cohort study of pregnant persons with CHD who delivered a singleton after 37 0/7 weeks gestation at a quaternary care center with a multidisciplinary cardio-obstetrics care team between 2013 and 2021. Patients were categorized as early-term (37 0/7 to 38 6/7 weeks) or full-term (≥39 0/7) births and compared. Multivariable logistic regression was conducted to calculate the adjusted odds ratio for the primary outcomes. The primary outcomes were composite adverse cardiovascular, maternal obstetric, and adverse neonatal outcome. Of 110 pregnancies delivering at term, 55 delivered early-term and 55 delivered full-term. Development of adverse cardiovascular and maternal obstetric outcome was not significantly different by delivery timing. The rate of composite adverse neonatal outcomes was significantly higher in early-term births (36% versus 5%, P<0.01). After adjusting for confounding variables, early-term birth remained associated with a significantly increased risk of adverse neonatal outcomes (adjusted odds ratio 11.55 [95% CI, 2.59-51.58]). Conclusions Early-term birth for pregnancies with maternal CHD was associated with an increased risk of adverse neonatal outcomes, without an accompanying decreased rate in adverse cardiovascular or obstetric outcomes. In the absence of maternal or fetal indications for early birth, induction of labor before 39 weeks for pregnancies with maternal CHD should be reserved for routine obstetrical indications.

Partial Gland Ablation of Prostate Cancer: Effects of Repeat Treatment.

OBJECTIVE: To evaluate the near-term clinical and pathological effects of repeat partial gland ablation (PGA) in men with intermediate-risk prostate cancer (PCa). MATERIALS AND METHODS: One hundred seventy men with focal lesions of PCa (all GG2 or GG3) underwent PGA with high-intensity focused ultrasound (HIFU) or cryotherapy (CRYO) in prospective trials. Residual PCa in or near the ablation zone was found in 37 men after a first PGA; 30 went on to receive a second PGA and were the subjects of study. At 3 timepoints, baseline and 6 months after first and second ablations, quality-of-life (QOL) questionnaires (IIEF, IPSS) and MRI-guided biopsies (MRGB) were performed. Biopsies were targeted and systematic at baseline and in follow-up, comprehensively about the ablation zone. RESULTS: All 30 patients completed QOL questionnaires and 26 had MRGB at the 3 timepoints. Mean QOL scores were not significantly different from the baseline after the first or second PGA. No operative complications were encountered; and "decisional regret" was reported in only 2/29 men after the repeat ablation. A decrease in semen volume was reported by 25% of patients. Repeat ablation was successful (absence of csPCa on MRGB) in 14/26 (53%) of men. PSA levels decreased and MRI lesions resolved after ablations, but neither was a reliable predictor of biopsy outcomes. CONCLUSION: When initial PGA fails, repeat PGA is a reasonable consideration, because in near-term follow-up, secondary procedures appear to be safe, causing only minimal detriment to urinary and sexual function, with csPCa becoming undetectable by MRGB in approximately half the patients.

Health Care Disparities Among Latina Patients Presenting With Pelvic Organ Prolapse.

IMPORTANCE: This study identifies barriers, including language and insurance status, Latina patients may face in accessing urogynecology care. OBJECTIVE: The aim of the study was to determine differences in objective prolapse severity at the time of presentation between Latina and non-Latina patients and the effect socioeconomic disparities may have on these differences. STUDY DESIGN: This is a retrospective cohort study of patients visiting urogynecology clinics at 2 academic institutions (1 private, 1 public). Patients with symptomatic > stage II prolapse were included. Initial Pelvic Organ Prolapse Quantification examinations, leading edge of prolapse, and demographic data were extracted. We evaluated several socioeconomic factors for associations with prolapse severity in a multivariable analysis. RESULTS: Three hundred forty-two patients were included (36% Latina). Twenty-eight percent were non-English speaking and 54% had public or no insurance. Using leading edge as the outcome, there was no objective difference in prolapse severity between the Latina and non-Latina patients. A higher proportion of patients with public insurance had more advanced prolapse compared with those with private insurance (odds ratio, 2.78; 95% confidence interval, 1.40-5.55; P < 0.01) and a higher proportion of non-English speaking had more advanced prolapse compared with English speakers (odds ratio, 2.44; 95% confidence interval, 1.12-5.34; P = 0.03). CONCLUSIONS: Latina ethnicity was not a risk factor for more advanced prolapse at the time of initial evaluation in a urogynecology clinic. Rather, patients who were non-English speaking and had public insurance were more likely to present with more advanced prolapse. Our data suggest that language barriers and lower socioeconomic status are health care disparities for patients seeking care for prolapse.

Quality of life in low-income men after surgical castration for metastatic prostate cancer.

OBJECTIVE: To compare health-related quality of life in men who underwent surgical vs. medical castration for metastatic prostate cancer. METHODS: We analyzed data from a prospective cohort of men enrolled in a statewide public health program that provides care for prostate cancer among low-income, uninsured men from 2001 to 2020. Outcome measures included the RAND SF-12 and the UCLA Prostate Cancer Index (PCI) at baseline and every 6 months. We used generalized estimating equations to assess the independent impact of surgical vs. medical castration on health-related quality of life. RESULTS: Among men with metastatic prostate cancer, 27 underwent orchiectomy, and 274 underwent medical castration. Median cohort age at enrollment was 61.3 years (IQR 56-65); 239 (79%) men had less than a high school education. Average follow-up was 8 months (range 0-45) since study enrollment. Seventy percent of patients within the surgical castration group had their orchiectomy prior to study enrollment (median months since orchiectomy at study enrollment was 9 months, IQR 1-43). Similarly, 59% of patients within the medical castration group had begun ADT prior to study enrollment (median months since ADT initiation at study enrollment was 4 months, IQR 1-12). The majority (66%) had metastatic disease at diagnosis. The 2 groups did not differ in age, race/ethnicity, education, monthly income, baseline PSA, Gleason score, or percent metastatic at diagnosis. SF-12 domains did not differ between those who underwent surgical vs. medical castration (on average throughout follow-up, physical component difference -2.0, 95% CI -8.0-3.9 and mental component difference -1.0, 95% CI -5.4-+3.4). Patients treated with orchiectomy reported better urinary function than those who underwent medical castration (+16 point, 95%CI 5.3-26). CONCLUSIONS: Surgical castration did not negatively impact general or disease-specific quality of life. The finding of improved urination after orchiectomy merits further inquiry. This may inform urologists' discussion of surgical vs. medical options for men with castration-sensitive metastatic prostate cancer.

Risk Factors for Measles Nonimmunity in Rubella-Immune Pregnant Patients.

OBJECTIVES: Measles immunity testing, unlike that for rubella, is not currently part of prenatal screening even though immunity to both is conferred by the measles-mumps-rubella (MMR) vaccine. Although endemic transmission of measles was declared eliminated in the United States in 2001, outbreaks have continued to occur. Given the risks associated with measles infection during pregnancy, we sought to identify risk factors for measles nonimmunity (MNI) in rubella-immune (RI) pregnant individuals. METHODS: We performed a retrospective observational cross-sectional study of patients receiving prenatal care and delivering at two university hospitals and a county hospital in Southern California from April 1, 2019 to February 1, 2021. Inclusion criteria were pregnant individuals ≥18 years old who had serological testing for rubella and measles during pregnancy. Demographic data were extracted from electronic medical records, including results of serological testing and chronic medical conditions. All subjects were rubella immune, and we compared measles-immune (MI) with MNI groups. RESULTS: In total, 1,813 RI individuals were identified, with 1,467 (81%) MI and 346 (19%) MNI individuals. Variables associated with an increased risk of MNI included having public health insurance (adjusted relative risk [aRR]: 1.56; 95% confidence interval [CI]: 1.24, 1.97) and Hispanic ethnicity (aRR: 1.37; 95% CI: 1.06, 1.78). Black race was associated with a decreased risk of MNI (aRR: 0.52; 95% CI: 0.29, 0.91). Birth year before 1989 demonstrated a trend toward increased risk of MNI, but this did not reach statistical significance (aRR 1.23; 95% CI: 1.00, 1.52). No differences were seen between the two groups for medical comorbidities. CONCLUSION: Our study is the first to demonstrate risk factors for measles MNI in patients with documented rubella immunity. In the absence of universal measles serological screening recommendations, the risk factors identified could help guide clinicians in selective screening for those at risk of needing postpartum MMR vaccination. KEY POINTS: · The rate of measles nonimmunity is higher than previously reported.. · Hispanic ethnicity and use of public insurance are risk factors for measles nonimmunity.. · The current recommendation for history-based screening for measles immunity is likely insufficient..

Targeted Prostate Biopsy: Umbra, Penumbra, and Value of Perilesional Sampling.

BACKGROUND: Systematic prostate biopsies add to the cancer detection rate of targeted biopsies, but the explanation for that increased sensitivity is not yet clear. OBJECTIVE: To determine and quantify the utility of perilesional biopsies in the detection of clinically significant prostate cancer (csPCa). DESIGN, SETTING, AND PARTICIPANTS: Participants were 2048 men with magnetic resonance imaging (MRI) lesions (grades 3-5) who underwent targeted and systematic prostate biopsy via MRI/ultrasound fusion at University of California Los Angeles and Cornell between 2011 and 2019. The study is a retrospective examination of prospectively acquired data. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: All biopsy cores (30191), locations of which had been stored digitally in the image-fusion device, were analyzed for tissue pathology and relationship with MRI lesions. A validated Matlab script was used to determine the distance between MRI lesions and cores containing csPCa (3552 cores from 927 men). Significance of distance measurements was determined by multilevel, multivariable logistic regression to account for within patient-biopsy correlation and control for patient characteristics. RESULTS AND LIMITATIONS: Overall, 90% (95% confidence interval [CI] = 89-91) of csPCa cores (3206/3552) were located within a radius of 10 mm from the nearest lesion: 65% (95% CI = 63-67) within the region of interest (ROI) and 26% (95% CI = 24-27) outside the ROI but within the 10-mm "penumbra." The width of the penumbra or concentric band, which enclosed 90% of csPCa, was primarily related to MRI grade of lesion: grade 5, 5 mm; grade 4, 12 mm; grade 3, 16 mm. In 18% (95% CI = 15-20) of patients (166/927), csPCa was diagnosed only by sampling outside the MRI lesion, the yield decreasing with increasing distance. Limitations of MRI interpretation and fusion biopsy performance could affect the utility of these data in individual patients. CONCLUSIONS: Perilesional biopsies, that is, samples taken from a band of 10-mm radius outside MRI lesions (the penumbra), contain most cores of csPCa that are not present within the lesion. These data may help increase the performance characteristics of targeted prostate biopsy. PATIENT SUMMARY: We studied the locations of cancer within the prostate in men undergoing magnetic resonance imaging (MRI)-guided biopsy. We found that not all cancers are located within the MRI lesion, but 90% (95% confidence interval = 89-91) of the cancers arewithin 1 cm of the lesions. Biopsies taken from both within and around MRI lesions provide greater sensitivity for cancer detection than samples taken from the lesion only.