Transperineal biopsy devices in people with suspected prostate cancer - a systematic review and economic evaluation.

Background: People with suspected prostate cancer are usually offered either a local anaesthetic transrectal ultrasound-guided prostate biopsy or a general anaesthetic transperineal prostate biopsy. Transperineal prostate biopsy is often carried out under general anaesthetic due to pain caused by the procedure. However, recent studies suggest that performing local anaesthetic transperineal prostate biopsy may better identify cancer in particular regions of the prostate and reduce infection rates, while being carried out in an outpatient setting. Devices to assist with freehand methods of local anaesthetic transperineal prostate may also help practitioners performing prostate biopsies. Objectives: To evaluate the clinical effectiveness and cost-effectiveness of local anaesthetic transperineal prostate compared to local anaesthetic transrectal ultrasound-guided prostate and general anaesthetic transperineal prostate biopsy for people with suspected prostate cancer, and local anaesthetic transperineal prostate with specific freehand devices in comparison with local anaesthetic transrectal ultrasound-guided prostate and transperineal prostate biopsy conducted with a grid and stepping device conducted under local or general anaesthetic. Data sources and methods: We conducted a systematic review of studies comparing the diagnostic yield and clinical effectiveness of different methods for performing prostate biopsies. We used pairwise and network meta-analyses to pool evidence on cancer detection rates and structured narrative synthesis for other outcomes. For the economic evaluation, we reviewed published and submitted evidence and developed a model to assess the cost-effectiveness of the different biopsy methods. Results: We included 19 comparative studies (6 randomised controlled trials and 13 observational comparative studies) and 4 single-arm studies of freehand devices. There were no statistically significant differences in cancer detection rates for local anaesthetic transperineal prostate (any method) compared to local anaesthetic transrectal ultrasound-guided prostate (relative risk 1.00, 95% confidence interval 0.85 to 1.18) (n = 5 randomised controlled trials), as was the case for local anaesthetic transperineal prostate with a freehand device compared to local anaesthetic transrectal ultrasound-guided prostate (relative risk 1.40, 95% confidence interval 0.96 to 2.04) (n = 1 randomised controlled trial). Results of meta-analyses of observational studies were similar. The economic analysis indicated that local anaesthetic transperineal prostate is likely to be cost-effective compared with local anaesthetic transrectal ultrasound-guided prostate (incremental cost below £20,000 per quality-adjusted life-year gained) and less costly and no less effective than general anaesthetic transperineal prostate. local anaesthetic transperineal prostate with a freehand device is likely to be the most cost-effective strategy: incremental cost versus local anaesthetic transrectal ultrasound-guided prostate of £743 per quality-adjusted life-year for people with magnetic resonance imaging Likert score of 3 or more at first biopsy. Limitations: There is limited evidence for efficacy in detecting clinically significant prostate cancer. There is comparative evidence for the PrecisionPoint™ Transperineal Access System (BXTAccelyon Ltd, Burnham, UK) but limited or no evidence for the other freehand devices. Evidence for other outcomes is sparse. The cost-effectiveness results are sensitive to uncertainty over cancer detection rates, complication rates and the numbers of core samples taken with the different biopsy methods and the costs of processing them. Conclusions: Transperineal prostate biopsy under local anaesthetic is equally efficient at detecting prostate cancer as transrectal ultrasound-guided prostate biopsy under local anaesthetic but it may be better with a freehand device. local anaesthetic transperineal prostate is associated with urinary retention type complications, whereas local anaesthetic transrectal ultrasound-guided prostate has a higher infection rate. local anaesthetic transperineal prostate biopsy with a freehand device appears to meet conventional levels of costeffectiveness compared with local anaesthetic transrectal ultrasound-guided prostate. Study registration: This study is registered as PROSPERO CRD42021266443. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR134220) and is published in full in Health Technology Assessment Vol. 28, No. 60. See the NIHR Funding and Awards website for further award information.

A prostate biopsy can help determine if a person has prostate cancer. The main ways of performing a prostate biopsy involve taking small samples of the prostate out through the rectum (back passage) or through the perineum ­ the skin area between the anus and the scrotum (testicles). Both methods use ultrasound images from a probe inserted into the rectum to help the clinician see what they are doing. Taking samples through the rectum is usually carried out under local anaesthetic, whereas taking samples through the perineum is usually carried out under general anaesthetic. We wanted to find out if taking samples through the perineum under local anaesthetic (instead of general anaesthetic) would be equally effective at detecting prostate cancer as the other biopsy methods and whether there was any improvement or change in the sorts of side effects people may have. We also wanted to know if people found the biopsy painful or not. We carried out searches of computer research databases to find relevant clinical and cost-effectiveness studies and compared the effectiveness of the different biopsy methods they used. We read and summarised the results of the studies we found in our search. Our findings showed that taking biopsy samples through the perineum under local anaesthetic had rates of detecting prostate cancer similar to those of the other biopsy methods. But if the clinician also used a freehand device that helps guide the biopsy needle as part of the procedure, then this may be a better method for detecting cancer. The studies we found agreed that performing this prostate biopsy under local anaesthetic was not too painful for most people. Our economic estimates suggest that using a freehand device for local anaesthetic perineal (through the skin of the perineum) biopsy may be a cost-effective use of National Health Service resources.

Impact of Age on Perioperative Complications After Obliterative Vaginal Surgery.

IMPORTANCE: Obliterative vaginal surgery is often reserved for older patients with prolapse, but the effect of age as an independent risk factor for perioperative complications in this cohort is poorly understood. OBJECTIVE: The aim of this study was to assess the association between age and perioperative complications in women undergoing obliterative vaginal surgery. STUDY DESIGN: This was a retrospective cohort study that included 371 patients undergoing colpocleisis between 2010 and 2013 at a single academic medical center. Seventy demographic and clinical variables, including complications within 12 weeks of surgery, were analyzed. The χ2 and Fisher exact tests were used for categorical variables. Student t and Mann-Whitney U tests were used for continuous variables. Univariate logistic regression was performed to identify predictors of perioperative complications, and candidate variables with P < 0.2 were used in multivariate logistic regression. RESULTS: The mean patient age was 75.4 ± 6.4 years (range, 59-94 years). One hundred ten (29.7%) patients experienced at least 1 complication, the most common of which was urinary tract infection (n = 47, 12.7%). In the final multivariable model, only age (odds ratio, 1.05 per year; 95% confidence interval, 1.01-1.08) remained a significant predictor of perioperative complications. A cut point of age ≥70.5 years maximized sensitivity and specificity for predicting complications. CONCLUSIONS: Among women undergoing obliterative vaginal surgery, age is a predictor of perioperative complications. Each increasing year of age increases the complication likelihood by 1.05-fold, such that an 85-year-old woman is 1.05^20 or 2.65 times more likely than a 65-year-old woman to have a complication. A cut point of ≥70.5 years best predicted complications. Despite this association, severe perioperative complications following obliterative surgery are rare.

Knowledge of the Human Papillomavirus Vaccine and Willingness to Accept Vaccination in the Postpartum Period.

OBJECTIVES: Human papillomavirus (HPV) vaccines prevent cervical cancer. The inpatient postpartum period presents a unique window for vaccination. Our study investigates HPV vaccine knowledge, barriers to vaccination, and willingness to get vaccinated during inpatient postpartum care. MATERIALS AND METHODS: We conducted a cross-sectional survey of 147 participants, age 18 to 26, who delivered at our institution between November 1, 2019, and April 30, 2020. Participants completed a questionnaire that included demographics, vaccine knowledge, hesitancies, and willingness to vaccinate. We used descriptive statistics and compared groups with chi-square or Wilcoxon rank sum for categorical variables and t-test for continuous variables. RESULTS: Of the 147 patients, 58 (39.46%) were fully vaccinated against HPV and 89 (60.54%) of participants were unvaccinated or partially vaccinated. There was a greater proportion of African American and Asian participants among unvaccinated women (28.1% vs 20.7% and 16.9% vs 1.7%, respectively). Most unvaccinated participants (52.9%) were willing to get vaccinated in the postpartum unit. Both vaccinated and unvaccinated groups were similarly aware that the HPV vaccine prevents cervical and oropharyngeal cancers and genital warts. The top barrier to future vaccination was forgetting to complete the vaccination series. CONCLUSIONS: Most women were not fully vaccinated but were willing to receive their first dose while in the postpartum unit. African American women were less likely to be vaccinated and expressed more unwillingness to accept vaccination. We identified barriers to HPV vaccination that can be tackled with the initiation of inpatient postpartum vaccination.

Moving the needle: Quality improvement strategies to achieve guideline-concordant care of obstetric patients with severe hypertension.

OBJECTIVES: To improve timely treatment and follow-up of birthing individuals with severe hypertension. STUDY DESIGN: A quality improvement (QI) initiative was implemented at an academic tertiary care center in the United States of America for individuals with obstetric hypertensive emergencies. Statistical process control charts were utilized to track process measures and interventions tested through plan-do-study-act cycles. Measures were disaggregated by race and ethnicity to identify and improve disparities. MAIN OUTCOME MEASURES: Treatment of hypertensive events within 60 min, receipt of blood pressure (BP) device at discharge and completed postpartum follow-up BP check within 7 days of discharge. RESULTS: All process measures showed statistically significant improvements. The primary process measure, timely treatment of hypertensive emergencies, improved from 29 % to 76 %. Receipt of BP device improved from 37 % to 91 % and follow-up BP checks from 58 % to 81 %. No racial or ethnic disparities were noted at baseline or after interventions. Readmission rates within 6 weeks of delivery increased from 2.3 % to 6.1 % for the cohort with no severe morbidity or mortality events after discharge. Strategies associated with improvement included project launch with establishment of the "why," telehealth, simulation, a video display of quality metrics on the birthing unit, promoting BP cuff access, and automated orders. CONCLUSIONS: This comprehensive QI initiative provides novel improvement strategies for the management of individuals with severe hypertensive disorders of pregnancy for the timely treatment of severe BP, attainment of home BP devices, and follow-up after discharge. Quality improvement methodology is practical and essential for achieving guideline-concordant care.

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.

Urethral Bulking With Polyacrylamide Hydrogel Compared With Other Treatments for Stress Urinary Incontinence: A Cost-Effectiveness Analysis.

Our objective was to perform a cost-effectiveness analysis comparing polyacrylamide hydrogel urethral bulking with other surgical and nonsurgical treatments for stress urinary incontinence (SUI). We created a cost-effectiveness analysis using TreeAge Pro, modeling eight SUI treatments. Treatment with midurethral sling (MUS) had the highest effectiveness (1.86 quality-adjusted life-years [QALYs]), followed by polyacrylamide hydrogel (1.82 QALYs), with a difference (Δ 0.02/year) less than the minimally important difference for utilities of 0.03 annually. When the proportion of polyacrylamide hydrogel urethral bulking procedures performed in the office setting is greater than 58%, polyacrylamide hydrogel is a cost-effective treatment for SUI, along with pessary, pelvic floor physical therapy, and MUS. Although MUS is more effective and, therefore, the preferred SUI treatment, polyacrylamide hydrogel is a reasonable alternative depending on patient preferences and treatment goals.

Comparing Postoperative Pain With Laparoscopic Versus Robotic Sacrocolpopexy.

STUDY OBJECTIVE: To compare postoperative pain and pain-related outcomes after laparoscopic (LS-MISC) vs robotic minimally invasive sacrocolpopexy (R-MISC). DESIGN: A secondary analysis of an original placebo-controlled randomized controlled trial (RCT) examining preoperative intravenous (IV) acetaminophen on postoperative pain after MISC. SETTING: Planned secondary analysis of multicenter RCT. PATIENTS: Women undergoing MISC. INTERVENTIONS: Coprimary outcomes at 24 hours were total opioid use in morphine milligram equivalents (MMEs) and visual analog scale (VAS) pain scores comparing LS-MISC and R-MISC. The secondary outcome was pain scores using a pain diary through 7 days after the procedure. MEASUREMENTS AND MAIN RESULTS: The original study was a double-blind, multicenter, RCT comparing IV acetaminophen with placebo that took place between 2014 and 2017. Given that the original trial was unable to show an impact from the use of IV acetaminophen, our analysis focused on the impact of surgical modality. We included 90 subjects undergoing MISC: 65 LS-MISC and 25 R-MISC. Most were Caucasian (97.8%) and postmenopausal (88.9%) with mean age of 61.2 ± 7.2 years and body mass index of 27.6 ± 4.4 kg/m2. IV acetaminophen did not affect pain in the original study and was not different between LS-MISC and R-MISC. Concomitant hysterectomy was performed in 67% (LS-MISC) vs 60% (R-MISC, p = .49). LS-MISC underwent more perineorrhaphies (15.4% vs 0%, p = .04) and posterior repairs (18.5% vs 0%, p = .02). Operative time was longer with LS-MISC (208.5 ± 57.3 vs 143.6 ± 21.0 minutes, p <.01). Length of stay was longer with LS-MISC (0.9 ± 0.4 vs 0.7 ± 0.4 days, p = .02). Women undergoing LS-MISC consumed more opioid MMEs through 24 hours when including intraoperative opioids (48.5 ± 25.5 vs 35.1 ± 14.6 MME, p <.01). Using linear regression correcting for operative time and concomitant vaginal repairs, this difference disappeared. Likewise, when intraoperative opioids were excluded, there was no difference. There were no differences in 24-hour postoperative VAS scores, opioid use in the first week, or quality of life (Patient-Reported Outcomes Measurement Information System - Pain Interference Short Form, all p <.05). CONCLUSION: When comparing VAS pain scores, MME opioid usage, and quality of life between LS-MISC and R-MISC, either there was no difference or differences disappeared after adjusting for confounders. Overall, opioid use, pain scores, and opioid side effects were low.

Cost-Utility Analysis of Midurethral Sling Timing Among Women Undergoing Prolapse Surgery.

IMPORTANCE: There are no guidelines regarding the ideal timing of midurethral sling (MUS) placement following prolapse repair. OBJECTIVE: The objective of this study was to estimate the cost-utility of concomitant MUS versus staged MUS among women undergoing apical suspension surgery for pelvic organ prolapse. STUDY DESIGN: Cost-utility modeling using a decision analysis tree compared concomitant MUS with staged MUS over a 1-year time horizon. The primary outcome was the incremental cost-effectiveness ratio (ICER). Six scenarios were modeled to estimate cost-utilities for women with preoperative overt, occult, or no stress urinary incontinence (SUI) who underwent either minimally invasive sacrocolpopexy or vaginal native tissue apical suspension. Possible complications of de novo overactive bladder, urinary retention requiring sling lysis, mesh exposure, and persistent SUI were included. Costs from a third-party payer perspective were derived from Medicare 2022 reimbursements. One-way sensitivity analyses were performed. RESULTS: Among women without preoperative SUI, staged MUS was the dominant strategy for both surgical routes with higher utility and lower costs. For women with either occult or overt SUI undergoing sacrocolpopexy or vaginal repair, concomitant MUS was cost-effective (ICER = $21,114-$96,536 per quality-adjusted life-year). Therefore, concomitant MUS is preferred for patients with preoperative SUI as higher costs were offset by higher effectiveness. One-way sensitivity analyses demonstrated that ICERs were most affected by probability of cure following MUS. CONCLUSIONS: A staged MUS procedure is the dominant strategy for women undergoing apical prolapse repair without preoperative SUI. In women with either overt or occult SUI, the ICER was below the willingness-to-pay threshold of $100,000 per quality-adjusted life-year, suggesting that concomitant MUS surgery is cost-effective.

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.

Alcohol prices, the April effect, and the environment, in violence-related injury in England and Wales.

Violent injury varies widely across England and Wales as does the price of alcohol. While the links between alcohol consumption and violence are well established in the medical and epidemiological literature, a causal link is questionable. This paper cuts through the causative argument by reporting a link between the general price of alcohol and violence-related injury across the economic regions of England and Wales. It examines the influence of the real price of alcohol and identifies an 'April effect' that coincides with the annual uprating of alcohol prices for excise duties, on violence-related injuries recorded at Emergency Department attendance. The data are monthly frequency of violent injury rates covering the period 2005-2014 across the economic regions. The principal finding is that a one-way relationship between the real price of alcohol and violent injury is established, and tax policy can be used to reduce the incidence of violent injury and the associated health costs.

Hemoglobin A1c and Reoperation After Surgery for Stress Incontinence or Prolapse.

IMPORTANCE: Few studies compare the link between hemogobin A1c (HbA1c) and urogynecologic surgical complications. OBJECTIVE: The objective of this study was to determine the association between HbA1c and reoperation in women undergoing surgery for stress urinary incontinence (SUI) or pelvic organ prolapse (POP). STUDY DESIGN: We performed 2 separate retrospective cohort analyses using Cerner's HealthFacts Database (750 hospitals; 519,000,000 patient encounters from January 1, 2010, to November 30, 2018). We included women undergoing surgery for (1) SUI or (2) apical POP by International Classification of Diseases coding who had HbA1c at the initial procedure. Each analysis compared those undergoing reoperation for complications or recurrence and those who did not. Multivariable logistic regression assessed the association between reoperation and HbA1c both as a continuous variable and comparing the commonly accepted cutoff ≥8. RESULTS: Of 30,180 SUI surgical procedures and 26,389 POP surgical procedures, 1,625 (5.4%) and 805 (3.1%) had HbA1c. Median (interquartile range) HbA1c in grams per deciliter was similar by reoperation status (SUI: 6.0 [5.6-6.8] vs 6.1 [5.6-6.9], P = 0.35; POP: 6.2 [5.6-6.6] vs 6.1 [5.7-6.8], P = 0.60). Reoperation was also similar using the HbA1c ≥8% cutoff (SUI: 6.9% vs 7.4%, P = 0.79; POP: 6.3% vs 5.4%, P = 0.77). On multivariate analysis, HbA1c value was not a significant predictor of reoperation either as a continuous (SUI: odds ratio [OR] = 0.966, 95% CI = 0.833-1.119; POP: OR = 1.040, 95% CI = 0.801-1.350) or dichotomous variable ≥8 (SUI: OR = 0.767, 95% CI = 0.407-1.446; POP: OR = 0.988, 95% CI = 0.331-2.951). Mean follow-up was 4.28-5.13 years. CONCLUSION: Although other studies have shown a link between diabetes and complications, we were unable to show an association between HbA1c values and rates of reoperation.

Linking emergency care and police department data to strengthen timely information on violence-related paediatric injuries.

BACKGROUND: Combined ED and police department (PD) data have improved violence surveillance in the UK, enabling significantly improved prevention. We sought to determine if the addition of emergency medical service (EMS) data to ED data would contribute meaningful information on violence-related paediatric injuries beyond PD record data in a US city. METHODS: Cross-sectional data on self-reported violence-related injuries of youth treated in the ED between January 2015 and September 2016 were combined with incidents classified by EMS as intentional interpersonal violence and incidents in which the PD responded to a youth injury from a simple or aggravated assault, robbery or sexual offence. Nearest neighbour hierarchical spatial clustering detected areas in which 10 or more incidents occurred during this period (hotspots), with the radii of the area being 1000, 1500, 2000 and 3000 ft. Overlap of PD incidents within ED&EMS hotspots (and vice versa) was calculated and Spearman's r tested statistical associations between the data sets, or ED&EMS contribution to PD violence information. RESULTS: There were 935 unique ED&EMS records (ED=381; EMS=554). Of these, 877 (94%) were not in PD records. In large hotspots >2000 ft, ED&EMS records identified one additional incident for every three in the PD database. ED and EMS provided significant numbers of incidents not reported to PD. Significant correlations of ED&EMS incidents in PD hotspots imply that the ED&EMS incidents are as pervasive across the city as that reported by PD. In addition, ED and EMS provided unique violence information, as ED&EMS hotspots never included a majority (>50%) of PD records. Most (676/877; 77%) incidents unique to ED&EMS records were within 1000 ft of a school or park. CONCLUSIONS: Many violence locations in ED and EMS data were not present in PD records. A combined PD, ED and EMS database resulted in new knowledge of the geospatial distribution of violence-related paediatric injuries and can be used for data-informed and targeted prevention of violence in which children are injured-especially in and around schools and parks.

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.

Patient decision support resources inform decisions about cancer susceptibility genetic testing and risk management: a systematic review of patient impact and experience.

Background: Patients with genetic cancer susceptibility are presented with complex management options involving difficult decisions, for example about genetic testing, treatment, screening and risk-reducing surgery/medications. This review sought to explore the experience of patients using decision support resources in this context, and the impact on decision-making outcomes. Methods: Systematic review of quantitative, qualitative and mixed-methods studies involving adults with or without cancer who used a decision support resource pre- or post-genetic test for any cancer susceptibility. To gather a broad view of existing resources and gaps for development, digital or paper-based patient resources were included and not limited to decision aids. Narrative synthesis was used to summarise patient impact and experience. Results: Thirty-six publications describing 27 resources were included. Heterogeneity of resources and outcome measurements highlighted the multiple modes of resource delivery and personal tailoring acceptable to and valued by patients. Impact on cognitive, emotional, and behavioural outcomes was mixed, but mainly positive. Findings suggested clear potential for quality patient-facing resources to be acceptable and useful. Conclusions: Decision support resources about genetic cancer susceptibility are likely useful to support decision-making, but should be co-designed with patients according to evidence-based frameworks. More research is needed to study impact and outcomes, particularly in terms of longer term follow-up to identify whether patients follow through on decisions and whether any increased distress is transient. Innovative, streamlined resources are needed to scale up delivery of genetic cancer susceptibility testing for patients with cancer in mainstream oncology clinics. Tailored patient-facing decision aids should also be made available to patients identified as carriers of a pathogenic gene variant that increases future cancer risks, to complement traditional genetic counselling. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020220460, identifier: CRD42020220460.

The reintroduction of hemp in the USA: a content analysis of state and tribal hemp production plans.

BACKGROUND: The reintroduction of Cannabis sativa L. in the form of hemp (< 0.3% THC by dry weight) into the US agricultural sector has been complex and remains confounded by its association with cannabis (> 0.3% THC by dry weight). This has been further exacerbated by inconsistent hemp regulations in the US since the 2014 Farm Bill's reintroduction. METHODS: A content analysis was performed to analyze the terms and definitions presented by state and tribal hemp production plans, the USDA Hemp producer license, and the 2014 state pilot plans. A total of 69 hemp production plans were analyzed. RESULTS: Results suggest significant discrepancies between hemp production plans, which have been exacerbated by extending the 2014 Farm Bill language into the 2018 Farm Bill timeframe. CONCLUSIONS: Findings from this study point to areas in need of uniformity and consistency as the regulatory framework is modified and provides a starting point for change for federal policymakers. The results may also be useful to companies attempting to market products across state boundaries. Suggestions for how to mitigate these inconsistencies are provided based on the content analysis findings.

Using the Cardiff model to reduce late-night alcohol-related presentations in regional Australia.

INTRODUCTION: The Cardiff model is a data sharing approach that aims to reduce the volume of intoxicated patients in emergency departments (EDs). This approach has not been tested in a rural setting. OBJECTIVE: This study assessed whether this approach would reduce the number of alcohol-associated presentations during high-alcohol hours (HAH) in a regional ED. DESIGN: From July 2017, people over the age of 18 attending the ED were asked by the triage nurse (1) whether they had consumed alcohol in the past 12 h, (2) their typical alcohol consumption level, (3) the location where most alcohol was purchased and (4) the location of the last drink. From April 2018, quarterly letters were sent to the top five venues reported within the ED. Deidentified, aggregated data were shared with local police, licensing authorities and local government, identifying the top five venues reported in the ED and providing a summary of alcohol-related attendances to the ED. Interrupted time series analyses were used to estimate the influence of the intervention on monthly injury and alcohol-related ED presentations. FINDINGS: ITS models found that there was a significant gradual decrease in the monthly rate of injury attendances during HAH (Coefficient = -0.004, p = 0.044). No other significant results were found. DISCUSSION: Our study found that sharing last drinks data collected in the ED with a local violence prevention committee was associated with a small, but significant reduction in the rate of injury presentations compared with all ED presentations. CONCLUSION: This intervention continues to have promise for reducing alcohol-related harm.

Landscape of Genetic Alterations Underlying Hallmark Signature Changes in Cancer Reveals TP53 Aneuploidy-driven Metabolic Reprogramming.

The hallmark signatures based on gene expression capture core cancer processes. Through a pan-cancer analysis, we describe the overview of hallmark signatures across tumor types/subtypes and reveal significant relationships between these signatures and genetic alterations. TP53 mutation exerts diverse changes, including increased proliferation and glycolysis, which are closely mimicked by widespread copy-number alterations. Hallmark signature and copy-number clustering identify a cluster of squamous tumors and basal-like breast and bladder cancers with elevated proliferation signatures, frequent TP53 mutation, and high aneuploidy. In these basal-like/squamous TP53-mutated tumors, a specific and consistent spectrum of copy-number alterations is preferentially selected prior to whole-genome duplication. Within Trp53-null breast cancer mouse models, these copy-number alterations spontaneously occur and recapitulate the hallmark signature changes observed in the human condition. Together, our analysis reveals intertumor and intratumor heterogeneity of the hallmark signatures, uncovering an oncogenic program induced by TP53 mutation and select aneuploidy events to drive a worsened prognosis. Significance: Our data demonstrate that TP53 mutation and a resultant selected pattern of aneuploidies cause an aggressive transcriptional program including upregulation of glycolysis signature with prognostic implications. Importantly, basal-like breast cancer demonstrates genetic and/or phenotypic changes closely related to squamous tumors including 5q deletion that reveal alterations that could offer therapeutic options across tumor types regardless of tissue of origin.

Differences in Sexual and Physical Abuse History by Presenting Chief Complaint in an Outpatient Urogynecology Population.

IMPORTANCE: One in 3 women experience sexual or physical violence in their lifetimes. Health consequences for survivors are numerous, including urogynecologic symptoms. OBJECTIVES: We aimed to determine prevalence and factors that predict a history of sexual or physical abuse (SA/PA) in outpatient urogynecology, specifically whether the chief complaint (CC) predicts a history of SA/PA. STUDY DESIGN: This cross-sectional study analyzed 1,000 newly presenting patients to 1 of 7 urogynecology offices in western Pennsylvania from November 2014 to November 2015. All sociodemographic/medical data were retrospectively abstracted. Univariable and multivariable logistic regression analyzed risk factors based on known associated variables. RESULTS: One thousand new patients had a mean age of 58.4 ± 15.8 years with a body mass index (BMI) of 28.8 ± 6.5. Nearly 12% reported a history of SA/PA. Patients with CC of pelvic pain were more than twice as likely to report abuse compared with all other CCs (odds ratio [OR], 2.690; 95% confidence interval [CI], 1.576-4.592). Prolapse was the most common CC (36.2%) but had the lowest prevalence of abuse (6.1%). Nocturia was an additional urogynecologic variable predictive of abuse (OR, 1.162 per nightly episode; 95% CI, 1.033-1.308). Increasing BMI and decreasing age both increased the risk of SA/PA. Smoking conferred the highest likelihood of abuse history (OR, 3.676; 95% CI, 2.252-5.988). CONCLUSIONS: Although those with a CC of prolapse were less likely to report abuse history, we recommend routine screening for all women. Pelvic pain was the most common CC among women reporting abuse. Special efforts should be made to screen those at higher risk with complaints of pelvic pain who are younger, smokers, with higher BMI, and with increased nocturia.

Universal Urogynecologic Consultation and Screening for Fecal Incontinence in Pregnant Women With a History of Obstetric Anal Sphincter Injury: A Cost-Effectiveness Analysis.

IMPORTANCE: Obstetric anal sphincter injuries (OASIS) predispose for the development of fecal incontinence (FI), but management of subsequent pregnancy after OASIS is controversial. OBJECTIVE: We aimed to determine if universal urogynecologic consultation (UUC) for pregnant women with prior OASIS is cost-effective. STUDY DESIGN: We performed a cost-effectiveness analysis of pregnant women with a history of OASIS modeling UUC compared with no referral (usual care). We modeled the route of delivery, peripartum complications, and subsequent treatment options for FI. Probabilities and utilities were obtained from published literature. Costs using a third-party payer perspective were gathered from the Medicare physician fee schedule reimbursement data or published literature converted to 2019 U.S. dollars. Cost-effectiveness was determined using incremental cost-effectiveness ratios). RESULTS: Our model demonstrated that UUC for pregnant patients with prior OASIS was cost-effective. Compared with usual care, the incremental cost-effectiveness ratio for this strategy was $19,858.32 per quality-adjusted life-year, below the willingness to pay a threshold of $50,000/quality-adjusted life-year. Universal urogynecologic consultation reduced the ultimate rate of FI from 25.33% to 22.67% and reduced patients living with untreated FI from 17.36% to 1.49%. Universal urogynecologic consultation increased the use of physical therapy by 14.14%, whereas rates of sacral neuromodulation and sphincteroplasty increased by only 2.48% and 0.58%, respectively. Universal urogynecologic consultation reduced the rate of vaginal delivery from 97.26% to 72.42%, which in turn led to a 1.15% increase in peripartum maternal complications. CONCLUSIONS: Universal urogynecologic consultation in women with a history of OASIS is a cost-effective strategy that decreases the overall incidence of FI, increases treatment utilization for FI, and only marginally increases the risk of maternal morbidity.