Disadvantaged groups have greater spatial access to pharmacies in New York state.

BACKGROUND: The accessibility of pharmacies has been associated with overall health and wellbeing. Past studies have suggested that low income and racial minority communities are underserved by pharmacies. However, the literature is inconsistent in finding links between area-level income or racial and ethnic composition and access to pharmacies. Here we aim to assess area-level spatial access to pharmacies across New York State (NYS), hypothesizing that Census Tracts with higher poverty rates and higher percentages of Black and Hispanic residents would have lower spatial access. METHODS: The population weighted mean shortest road network distance (PWMSD) to a pharmacy in 2018 was calculated for each Census Tract in NYS. This statistic was calculated from the shortest road network distance to a pharmacy from the centroid of each Census block within a tract, with the mean across census blocks weighted by the population of the census block. Cross-sectional analyses were conducted to assess links between Tract-level socio demographic characteristics and Tract-level PWMSD to a pharmacy. RESULTS: Overall the mean PWMSD to a pharmacy across Census tracts in NYS was 2.07 Km (SD = 3.35, median 0.85 Km). Shorter PWMSD to a pharmacy were associated with higher Tract-level % poverty, % Black/African American (AA) residents, and % Hispanic/Latino residents and with lower Tract-level % of residents with a college degree. Compared to tracts in the lowest quartile of % Black/AA residents, tracts in the highest quartile had a 70.7% (95% CI 68.3-72.9%) shorter PWMSD to a pharmacy. Similarly, tracts in the highest quartile of % poverty had a 61.3% (95% CI 58.0-64.4%) shorter PWMSD to a pharmacy than tracts in the lowest quartile. CONCLUSION: The analyses show that tracts in NYS with higher racial and ethnic minority populations and higher poverty rates have higher spatial access to pharmacies.

Comorbidity burden and health-related quality of life in men with advanced prostate cancer.

PURPOSE: Identifying clinically relevant comorbidities and their effect on health-related quality of life (HRQoL) outcomes among men with advanced prostate cancer (APC) can inform patient care and improve outcomes; however, this is poorly understood. The aim of this observational study was to examine the prevalence of comorbidities, and the relationship of comorbidity burden to HRQoL and other patient-reported outcomes (PROs) among men with APC. METHODS: Participants were 192 men (average age 68.8) with APC (stage III or IV) who completed a psychosocial battery including measures of sociodemographic factors, HRQoL and other PROs, and the Charlson Comorbidity Index (CCI). Hierarchical multiple regression analysis was used to examine the relationships between CCI, HRQOL, and PROs. RESULTS: The vast majority (82%) of participants had at least one comorbidity, with the most common being: hypertension (59%), connective tissue disease or arthritis (31%), diabetes (24%), and problems with kidneys, vision, or another organ (24%). After controlling for covariates, regressions showed that a higher CCI score was significantly associated with worse HRQoL (p < 0.001), lower levels of positive affect (p < 0.05), and higher levels of depression (p < 0.05), fatigue (p < 0.001), pain (p < 0.01), stress (p < 0.01), and cancer-specific distress (p < 0.05). CONCLUSIONS: Comorbidities were common among men with APC, and a greater CCI score was associated with detriments in several domains of HRQoL and other PROs. Our findings show the need to address comorbidities in the presence of a cancer diagnosis and subsequent treatment. TRIAL REGISTRATION CLINICALTRIALS. GOV IDENTIFIER: NCT03149185.

Structural Racism and Breast Cancer-specific Survival: Impact of Economic and Racial Residential Segregation.

OBJECTIVE: To analyze the effect of economic and racial/ethnic residential segregation on breast cancer-specific survival (BCSS) in South Florida, a diverse metropolitan area that mirrors the projected demographics of many United States regions. SUMMARY BACKGROUND DATA: Despite advances in diagnosis and treatment, racial and economic disparities in BCSS. This study evaluates these disparities through the lens of racial and economic residential segregation, which approximate the impact of structural racism. METHODS: Retrospective cohort study of stage I to IV breast cancer patients treated at our institution from 2005 to 2017. Our exposures include index of concentration at the extremes, a measurement of economic and racial neighborhood segregation, which was computed at the census-tract level using American Community Survey data. The primary outcome was BCSS. RESULTS: Random effects frailty models predicted that patients living in low-income neighborhoods had higher mortality compared to those living in high-income neighborhoods [hazard ratios (HR): 1.56, 95% confidence interval (CI): 1.23-2.00]. Patients living in low-income non-Hispanic Black and Hispanic neighborhoods had higher mortality compared to those living in high-income non-Hispanic White (NHW) neighborhoods (HR: 2.43, 95%CI: 1.72, 3.43) and (HR: 1.99, 95%CI: 1.39, 2.84), after controlling for patient characteristics, respectively. In adjusted race-stratified analysis, NHWs living in low-income non-Hispanic Black neighborhoods had higher mortality compared to NHWs living in high-income NHW neighborhoods (HR: 4.09, 95%CI: 2.34-7.06). CONCLUSIONS: Extreme racial/ethnic and economic segregation were associated with lower BCSS. We add novel insight regarding NHW and Hispanics to a growing body of literature that demonstrate how the ecological effects of structural racism-expressed through poverty and residential segregation-shape cancer survival.

Residential segregation and overall survival of women with epithelial ovarian cancer.

BACKGROUND: To the authors' knowledge, the etiology of survival disparities in patients with epithelial ovarian cancer (EOC) is not fully understood. Residential segregation, both economic and racial, remains a problem within the United States. The objective of the current study was to analyze the effect of residential segregation as measured by the Index of Concentration at the Extremes (ICE) on EOC survival in Florida by race and/or ethnicity. METHODS: All malignant EOC cases were identified from 2001 through 2015 using the Florida Cancer Data System (FCDS). Census-defined places were used as proxies for neighborhoods. Using 5-year estimates from the American Community Survey, 5 ICE variables were computed: economic (high vs low), race and/or ethnicity (non-Hispanic white [NHW] vs non-Hispanic black [NHB] and NHW vs Hispanic), and racialized economic segregation (low-income NHB vs high-income NHW and low-income Hispanic vs high-income NHW). Random effects frailty models were conducted. RESULTS: A total of 16,431 malignant EOC cases were diagnosed in Florida among women living in an assigned census-defined place within the time period. The authors found that economic and racialized economic residential segregations influenced EOC survival more than race and/or ethnic segregation alone in both NHB and Hispanic women. NHB women continued to have an increased hazard of death compared with NHW women after controlling for multiple covariates, whereas Hispanic women were found to have either a similar or decreased hazard of death compared with NHW women in multivariable Cox models. CONCLUSIONS: The results of the current study indicated that racial and economic residential segregation influences survival among patients with EOC. Research is needed to develop more robust segregation measures that capture the complexities of neighborhoods to fully understand the survival disparities in EOC.

Combined General and Epidural Anesthesia is Associated With Decreased Opioid Consumption and Enhanced Pain Control After Penile Inversion Vaginoplasty in Transwomen.

BACKGROUND: Penile skin inversion vaginoplasty is a gender-affirming surgical procedure for transwomen with limited surgical analgesic protocol. This study compares the postoperative pain and opioid use in patients managed for surgery with general anesthesia (GA) with patients who were given combined epidural and general anesthesia (E/GA) with continuing postoperative epidural analgesia. METHODS: All patients who underwent penile inversion vaginoplasty between May of 2016 and May of 2018 under the care of single surgeon were identified retrospectively, 18 patients of which met the inclusion criteria. A retrospective chart review was conducted. Outcome measures were postoperative pain using visual analog scale, type and dosage of postoperatively administered intravenous or oral opioids (converted to morphine milligram equivalents, duration of inpatient admission, and time to ambulation. RESULTS: Patients who received combined E/GA reported significantly less pain and used less opioids during the first 4 postoperative days in comparison with patients who received GA alone. The reduction in mean pain associated with the use of an epidural was found to be statistically significant (P < 0.0005) as was the difference in opioid used in the 2 groups (P < 0.005) over the first 4 days postoperatively. Differences in day 5 pain suggest that postoperative pain is significantly lower even after the epidural has been removed (P < 0.005). There was no significant difference in length of hospital stay and time to ambulation (P > 0.05). CONCLUSIONS: Combined E/GA was associated with decreased inpatient opioid consumption after surgery and provided superior pain control than administration of GA alone. Based on these findings, combined E/GA should be strongly considered for patients undergoing penile inversion vaginoplasty.

The Impact of Immediate Salvage Surgery on Corporeal Length Preservation in Patients Presenting with Penile Implant Infections.

PURPOSE: Removal of an infected penile implant often results in corporeal fibrosis, irreversible penile shortening and dissatisfaction with future implant surgery. Salvage surgery may avoid these problems but to our knowledge no study to date has evaluated these specific end points. We evaluated patients who presented to our center with an infected implant to determine the impact of salvage surgery on penile length. MATERIALS AND METHODS: We evaluated consecutive patients undergoing removal of an infected penile prosthesis with immediate salvage or delayed reimplantation using a comprehensive, prospective database. Total corporeal length prior to and following immediate salvage or delayed reimplantation were compared. The impact of patient age, comorbidities, bacterial species, initial penile length and time to reimplantation on subsequent total corporeal length was evaluated. RESULTS: The cohort consisted of 40 patients. Overall 81% of salvaged cases were successful, resulting in a mean 0.6 cm (95% CI 0.20 to 1.1) reduction in total corporeal length. Delayed reimplantation resulted in a mean 3.7 cm (95% CI 2.9-4.5) total corporeal length loss. In patients who underwent delayed reimplantation the total corporeal length reduction was directly proportionate to the initial penis size of the patient. No statistically significant impact on penile length was attributable to patient age, diabetes, bacterial species or time to reimplantation. CONCLUSIONS: When possible, salvage surgery should be offered to patients with an infected penile implant. Our data confirmed that successful salvage surgery preserves penile length. When a device is explanted and replaced at a later date, patients can expect to lose 15% to 30% of penile length irrespective of age, diabetes, type of infecting organism and time to reimplantation.

Racial disparity and survival outcomes between African-American and Caucasian American men with penile cancer.

OBJECTIVE: To determine whether there is a survival difference for African-American men (AAM) versus Caucasian American men (CM) with penile squamous cell carcinoma (pSCC), particularly in locally advanced and metastatic cases where disease mortality is highest. PATIENTS AND METHODS: Using the Florida Cancer Data System, we identified men with pSCC from 2005 to 2013. We compared age, follow-up, stage, race, and treatment type between AAM and CM. We performed Kaplan-Meier analysis for overall survival (OS) between AAM and CM for all stages, and for those with locally advanced and metastatic disease. A multivariable model was developed to determine significant predictors of OS. RESULTS: In all, 653 men (94 AAM and 559 CM) had pSCC and 198 (30%) had locally advanced and/or metastatic disease. A higher proportion of AAM had locally advanced and/or metastatic disease compared to CM (38 [40%] vs 160 [29%], P = 0.03). The median (interquartile range) follow-up for the entire cohort was 12.6 (5.4-32.0) months. For all stages, AAM had a significantly lower median OS compared to CM (26 vs 36 months, P = 0.03). For locally advanced and metastatic disease, there was a consistent trend toward disparity in median OS between AAM and CM (17 vs 22 months, P = 0.06). After adjusting for age, stage, grade, and treatment type, AAM with pSCC had a greater likelihood of death compared to CM (hazard ratio 1.64, P = 0.014). CONCLUSIONS: AAM have worse OS compared to CM with pSCC and this may partly be due to advanced stage at presentation. Treatment disparity may also contribute to lessened survival in AAM, but we were unable to demonstrate a significant difference in treatment utilisation between the groups.

Variation in type II endometrial cancer risk by Hispanic subpopulation: An exploratory analysis.

BACKGROUND: Minorities have demonstrated an increased risk for type II endometrial cancers, but no data exists about risk among minority subpopulations. Our objective was to evaluate heterogeneity in risk of type II endometrial cancer (EC) histologies across race and Hispanic sub-groups using data from Florida's statewide cancer registry (FCDS). METHODS: FCDS contains data on N=26,416 women diagnosed with EC from 2004 to 2013. Our analysis included women ≥18years of age who were classified as non-Hispanic White (NHW), non-Hispanic Black (NHB) or belonged to one of five Hispanic sub-groups, and had a histology code consistent with type I or type II EC. Binary logistic regression analyses were performed to model risk of type II versus type I ECs across racial and ethnic groups relative to NHW. RESULTS: Relative to NHW, overall odds of being diagnosed with a type II EC were significantly higher in NHB (OR=2.64, 95%CI: 2.38-2.92), Cubans (OR=1.35, 95%CI: 1.08-1.68) and South and Central Americans (SCA) (OR=1.84, 95%CI: 1.40-2.43). Compared to NHW, odds of serous EC were significantly higher in Cubans (OR=2.15, 95% CI: 1.51-3.05) and NHB (OR=2.51, 95% CI: 2.11-2.97); odds of carcinosarcoma (CS) were significantly higher in NHB (OR=2.97, 95% CI: 2.47-3.57) and Puerto Ricans (OR=2.35, 95%CI: 1.32-4.17); and odds of grade III adenocarcinoma (AG3) were significantly higher in NHB (OR=1.60, 95% CI: 1.42-1.81) and SCA (OR=1.76, 95%CI: 1.29-2.40). CONCLUSION: Risk of type II EC varies considerably across Hispanic sub-groups, with Cubans, Puerto Ricans and SCA characterized by elevated odds for specific type II histologies.

Risk of cardiac disease and observations on lack of potential predictors by clinical history among children presenting for cardiac evaluation of mid-exertional syncope.

OBJECTIVE: This study aimed to evaluate the incidence of cardiac disorders among children with mid-exertional syncope evaluated by a paediatric cardiologist, determine how often a diagnosis was not established, and define potential predictors to differentiate cardiac from non-cardiac causes. Study design We carried out a single-centre, retrospective review of children who presented for cardiac evaluation due to a history of exertional syncope between 1999 and 2012. Inclusion criteria included the following: (1) age ⩽18 years; (2) mid-exertional syncope; (3) electrocardiogram, echocardiogram and an exercise stress test, electrophysiology study, or tilt test, with exception of long QT, which did not require additional testing; and (4) evaluation by a paediatric cardiologist. Mid-exertional syncope was defined as loss of consciousness in the midst of active physical activity. Patients with peri-exertional syncope immediately surrounding but not during active physical exertion were excluded. RESULTS: A total of 60 patients met the criteria for mid-exertional syncope; 32 (53%) were diagnosed with cardiac syncope and 28 with non-cardiac syncope. A majority of cardiac patients were diagnosed with an electrical myopathy, the most common being Long QT syndrome. In nearly half of the patients, a diagnosis could not be established or syncope was felt to be vasovagal in nature. Neither the type of exertional activity nor the symptoms or lack of symptoms occurring before, immediately preceding, and after the syncopal event differentiated those with or without a cardiac diagnosis. CONCLUSIONS: Children with mid-exertional syncope are at risk for cardiac disease and warrant evaluation. Reported symptoms may not differentiate benign causes from life-threatening disease.

Chronic sacral nerve stimulation as a novel treatment for stress urinary incontinence-A rat model.

AIMS: We propose an animal model to evaluate the effect of chronic sacral nerve stimulation (SNS) on surgically induced intrinsic sphincter deficiency (ISD) secondary to transabdominal urethrolysis (U-Lys). METHODS: Twenty-five 6-week old virgin female Sprague-Dawley rats were divided into four groups: control (CTRL), U-Lys only, SNS only, and both (U-Lys/SNS). Groups CTRL (N = 5) and U-Lys only (N = 5) were maintained in the animal research facility in standard fashion for 2 weeks. Groups SNS only (N = 5) and U-Lys/SNS (N = 10) underwent chronic SNS for 6 continuous hours daily for 2 weeks. Retrograde leak point pressure (RLPP) was measured at baseline and at 2 weeks following observation or treatment. Five consecutive RLPP measurements were averaged per measurement cycle. SAS 9.3 was used to evaluate means and standard deviation. RESULTS: Baseline mean RLPP was 65 mmHg. The U-Lys only group mean RLPP at initial urethrolysis (58 mmHg) decreased (31 mmHg, P < 0.0001) after 2 weeks of observation. In the SNS only group, mean RLPP significantly increased from baseline (73 mmHg) after 2 weeks of chronic SNS stimulation (80 mmHg, P < 0.01). In rats that underwent both U-Lys and SNS stimulation mean RLPP was initially low (46 mmHg) after U-Lys and then significantly increased after 2 weeks of SNS (65 mmHg, P < 0.0001). CONCLUSION: Chronic SNS mediates an improvement in urethral sphincteric function at stimulation parameters similar to those used in humans for treating voiding dysfunction. SNS increased urethral resistance in rats with and without surgically induced ISD.

Implementation of a standardized postanesthesia care handoff increases information transfer without increasing handoff duration.

BACKGROUND: In the transition of a patient from the operating room (OR) to the postanesthesia care unit (PACU), it was hypothesized that (1) standardizing the members of sending and receiving teams and (2) requiring a structured handoff process would increase the overall amount of patient information transferred in the OR-to-PACU handoff process. METHODS: A prospective cohort study was conducted at a 311-bed freestanding academic pediatric hospital in Northern California. The intervention, which was conducted in February-March 2013, consisted of (1) requiring the sending team to include a surgeon, an anesthesiologist, and a circulating nurse, and the receiving team to include the PACU nurse; (2) standardizing the content of the handoff on the basis of literature-guided recommendations; and (3) presenting the handoff verbally in the I-PASS format. Data included amount of patient information transferred, duration of handoff, provider presence, and nurse satisfaction. RESULTS: Forty-one audits during the preimplementation phase and 45 audits during the postimplementation phase were analyzed. Overall information transfer scores increased significantly from a mean score of 49% to 83% (p < .0001). Twenty-two PACU nurse satisfaction surveys were completed after the preimplementation phase and 14 surveys were completed in the postimplementation phase. Paired mean total satisfaction scores increased from 36 to 44 (p =. 004). The duration of the handoffs trended downward from 4.1 min to 3.5 min (p = 0.10). CONCLUSION: A standardized, team-based approach to OR-to-PACU handoffs increased the quantity of patient information transferred, increased PACU nurse satisfaction, and did not increase the handoff duration.

Empirically contrasting urine drug screening-based opioid use disorder treatment outcome definitions.

BACKGROUND AND AIMS: A lack of consensus on the optimal outcome measures to assess opioid use disorder (OUD) treatment efficacy and their precise definition and computation has hampered the pooling of research data for evidence synthesis and meta-analyses. This study aimed to empirically contrast multiple clinical trial definitions of treatment success by applying them to the same dataset. METHODS: Data analysis used a suite of functions, developed as a software package for the R language, to operationalize 61 treatment outcome definitions based on urine drug screening (UDS) results. Outcome definitions were derived from clinical trials that are among the most influential in the OUD treatment field. Outcome functions were applied to a harmonized dataset from three large-scale National Drug Abuse Treatment Clinical Trials Network (CTN) studies, which tested various medication for OUD (MOUD) options (n = 2492). Hierarchical clustering was employed to empirically contrast outcome definitions. RESULTS: The optimal number of clusters identified was three. Cluster 1, comprising eight definitions focused on detecting opioid-positive UDS, did not include missing UDS in outcome calculations, potentially resulting in inflated rates of treatment success. Cluster 2, with the highest variability, included 10 definitions characterized by strict criteria for treatment success, relying heavily on UDS results from either a brief period or a single study visit. The 43 definitions in Cluster 3 represented a diverse range of outcomes, conceptualized as measuring abstinence, use reduction and relapse. These definitions potentially offer more balanced measures of treatment success or failure, as they avoid the extreme methodologies characteristic of Clusters 1 and 2. CONCLUSIONS: Clinical trials using urine drug screening (UDS) for objective substance use assessment in outcome definitions should consider (1) incorporating missing UDS data in outcome computation and (2) avoiding over-reliance on UDS data confined to a short time frame or the occurrence of a single positive urine test following a period of abstinence.

Individual-Level Risk Prediction of Return to Use During Opioid Use Disorder Treatment.

Importance: No existing model allows clinicians to predict whether patients might return to opioid use in the early stages of treatment for opioid use disorder. Objective: To develop an individual-level prediction tool for risk of return to use in opioid use disorder. Design, Setting, and Participants: This decision analytical model used predictive modeling with individual-level data harmonized in June 1, 2019, to October 1, 2022, from 3 multicenter, pragmatic, randomized clinical trials of at least 12 weeks' duration within the National Institute on Drug Abuse Clinical Trials Network (CTN) performed between 2006 and 2016. The clinical trials covered a variety of treatment settings, including federally licensed treatment sites, physician practices, and inpatient treatment facilities. All 3 trials enrolled adult participants older than 18 years, with broad pragmatic inclusion and few exclusion criteria except for major medical and unstable psychiatric comorbidities. Intervention: All participants received 1 of 3 medications for opioid use disorder: methadone, buprenorphine, or extended-release naltrexone. Main Outcomes and Measures: Predictive models were developed for return to use, which was defined as 4 consecutive weeks of urine drug screen (UDS) results either missing or positive for nonprescribed opioids by week 12 of treatment. Results: The overall sample included 2199 trial participants (mean [SD] age, 35.3 [10.7] years; 728 women [33.1%] and 1471 men [66.9%]). The final model based on 4 predictors at treatment entry (heroin use days, morphine- and cocaine-positive UDS results, and heroin injection in the past 30 days) yielded an area under the receiver operating characteristic curve (AUROC) of 0.67 (95% CI, 0.62-0.71). Adding UDS in the first 3 treatment weeks improved model performance (AUROC, 0.82; 95% CI, 0.78-0.85). A simplified score (CTN-0094 OUD Return-to-Use Risk Score) provided good clinical risk stratification wherein patients with weekly opioid-negative UDS results in the 3 weeks after treatment initiation had a 13% risk of return to use compared with 85% for those with 3 weeks of opioid-positive or missing UDS results (AUROC, 0.80; 95% CI, 0.76-0.84). Conclusions and Relevance: The prediction model described in this study may be a universal risk measure for return to opioid use by treatment week 3. Interventions to prevent return to regular use should focus on this critical early treatment period.

Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing: A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial.

Importance: Buprenorphine significantly reduces opioid-related overdose mortality. From 2002 to 2022, the Drug Addiction Treatment Act of 2000 (DATA 2000) required qualified practitioners to receive a waiver from the Drug Enforcement Agency to prescribe buprenorphine for treatment of opioid use disorder. During this period, waiver uptake among practitioners was modest; subsequent changes need to be examined. Objective: To determine whether the Communities That HEAL (CTH) intervention increased the rate of practitioners with DATA 2000 waivers and buprenorphine prescribing. Design, Setting, and Participants: This prespecified secondary analysis of the HEALing Communities Study, a multisite, 2-arm, parallel, community-level, cluster randomized, open, wait-list-controlled comparison clinical trial was designed to assess the effectiveness of the CTH intervention and was conducted between January 1, 2020, to December 31, 2023, in 67 communities in Kentucky, Massachusetts, New York, and Ohio, accounting for approximately 8.2 million adults. The participants in this trial were communities consisting of counties (n = 48) and municipalities (n = 19). Trial arm randomization was conducted using a covariate constrained randomization procedure stratified by state. Each state was balanced by community characteristics including urban/rural classification, fatal opioid overdose rate, and community population. Thirty-four communities were randomized to the intervention and 33 to wait-list control arms. Data analysis was conducted between March 20 and September 29, 2023, with a focus on the comparison period from July 1, 2021, to June 30, 2022. Intervention: Waiver trainings and other educational trainings were offered or supported by the HEALing Communities Study research sites in each state to help build practitioner capacity. Main Outcomes and Measures: The rate of practitioners with a DATA 2000 waiver (overall, and stratified by 30-, 100-, and 275-patient limits) per 100 000 adult residents aged 18 years or older during July 1, 2021, to June 30, 2022, were compared between the intervention and wait-list control communities. The rate of buprenorphine prescribing among those waivered practitioners was also compared between the intervention and wait-list control communities. Intention-to-treat and per-protocol analyses were performed. Results: A total of 8 166 963 individuals aged 18 years or older were residents of the 67 communities studied. There was no evidence of an effect of the CTH intervention on the adjusted rate of practitioners with a DATA 2000 waiver (adjusted relative rate [ARR], 1.04; 95% CI, 0.94-1.14) or the adjusted rate of practitioners with a DATA 2000 waiver who actively prescribed buprenorphine (ARR, 0.97; 95% CI, 0.86-1.10). Conclusions and Relevance: In this randomized clinical trial, the CTH intervention was not associated with increases in the rate of practitioners with a DATA 2000 waiver or buprenorphine prescribing among those waivered practitioners. Supporting practitioners to prescribe buprenorphine remains a critical yet challenging step in the continuum of care to treat opioid use disorder. Trial Registration: ClinicalTrials.gov Identifier: NCT04111939.

Identifying Neighborhoods with Cervical Cancer Disparities for Targeted Community Outreach and Engagement by an NCI-Designated Cancer Center: A Geospatial Approach.

BACKGROUND: Cervical cancer disparities exist in the United States with the highest incidence in Hispanic women and the highest mortality in Black women. Effective control of cervical cancer in the population requires targeted interventions tailored to community composition in terms of race, ethnicity, and social determinants of health (SDOH). METHODS: Using cancer registry and SDOH data, geospatial hot spot analyses were carried out to identify statistically significant neighborhood clusters with high numbers of cervical cancer cases within the catchment area of an NCI-Designated Cancer Center. The locations, racial and ethnic composition, and SDOH resources of these hot spots were used by the center's community outreach and engagement office to deploy mobile screening units (MSU) for intervention in communities with women facing heightened risk for cervical cancer. RESULTS: Neighborhood hot spots with high numbers of cervical cancer cases in south Florida largely overlap with locations of poverty. Cervical cancer hot spots are associated with a high percentage of Hispanic cases and low SDOH status, including low income, housing tenure, and education attainment. CONCLUSIONS: A geospatially referenced cancer surveillance platform integrating cancer registry, SDOH, and cervical screening data can effectively identify targets for cervical cancer intervention in neighborhoods experiencing disparities. IMPACT: Guided with a data-driven surveillance system, MSUs proactively bringing prevention education and cervical screening to communities with more unscreened, at-risk women are an effective means for addressing disparities associated with cervical cancer control.

Capturing drug use patterns at a glance: An n-ary word sufficient statistic for repeated univariate categorical values.

INTRODUCTION: The efficacy of treatments for substance use disorders (SUD) is tested in clinical trials in which participants typically provide urine samples to detect whether the person has used certain substances via urine drug screenings (UDS). UDS data form the foundation of treatment outcome assessment in the vast majority of SUD clinical trials. However, existing methods to calculate treatment outcomes are not standardized, impeding comparability between studies and prohibiting reproducibility of results. METHODS: We extended the concept of a binary UDS variable to multiple categories: "+" [positive for substance(s) of interest], "-" [negative for substance(s)], "o" [patient failed to provide sample], "*" [inconclusive or mixed results], and "_" [no specimens required per study design]. This construct can be used to create a standardized and sufficient representation of UDS datastreams and sufficiently collapses longitudinal records into a single, compact "word", which preserves all information contained in the original data. RESULTS: We developed the R software package CTNote (available on CRAN) as a tool to enable computers to parse these "words". The software package contains five groups of routines: detect a substance use pattern, account for a specific trial protocol, handle missing UDS data, measure the longest period of consecutive behavior, and count substance use events. Executing permutations of these routines result in algorithms which can define SUD clinical trial endpoints. As examples, we provide three algorithms to define primary endpoints from seminal SUD clinical trials. DISCUSSION: Representing substance use patterns as a "word" allows researchers and clinicians an "at a glance" assessment of participants' responses to treatment over time. Further, machine readable use pattern summaries are a standardized method to calculate treatment outcomes and are therefore useful to all future SUD clinical trials. We discuss some caveats when applying this data summarization technique in practice and areas of future study.

Hyperlocal disparities in breast, cervical, and colorectal cancer screening: An ecological study of social vulnerability in Miami-Dade county.

Neighborhoods have been identified as important determinants of health-related outcomes, but limited research has assessed the influence of neighborhood context along the cancer continuum. This study used census tract-level data from the United States Census Bureau and Centers for Disease Control and Prevention to characterize Miami-Dade County census tracts (n = 492) into social vulnerability clusters and assess their associated breast, cervical, and colorectal cancer screening participation rates. We identified disparities by social vulnerability cluster in cancer screening participation rates. Further investigation of geographic disparities in social vulnerability and cancer screening participation could inform equity-focused cancer control efforts.

Impacts of the New York State COVID-19 disaster emergency orders on prescription dispensing for opioids and medication for opioid use disorder.

AIMS: The aim of this study is to examine whether the March 2020 New York State (NYS) SARS-CoV-2 emergency orders were associated with an initial surge in opioid dispensing and a longer-term reduction in access to medications for opioid use disorder (MOUD). DESIGN: Time-series analyses of the dispensing of non-MOUD opioid and MOUD prescriptions using IQVIA's longitudinal prescription claims database (n = 16 087 429) in NYS by week, from 1 January 2018 to 31 July 2020. IQVIA is a multi-national company that provides biopharmaceutical development and commercial outsourcing services. SETTING AND PARTICIPANTS: NYS Zone Improvement Plan (ZIP) codes (n = 1218) in which prescriptions were dispensed. MEASUREMENT: For each ZIP code, for each week, the following dispensing measures were calculated: total weekly morphine milligram equivalents/day (MME/day), total weekly MME/day dispensed via prescriptions for ≤ 7 days and the count of MOUD prescriptions dispensed. Differences in dispensing metrics, comparing each week in 2020 with corresponding weeks in 2019, were calculated for each ZIP code. RESULTS: During the study period, weekly MME/day per ZIP code of dispensed non-MOUD opioids steadily declined. Compared with the difference in dispensing between 2019 and 2020 during the first week in 2020, there was a significantly larger drop in dispensed weekly total MME/day beginning 21 March 2020, and lasting until the week of 17 April (P < 0.05 for each week). Mean weekly total MME/day dispensed from 21 March to 17 April 2020 was 17.07% lower [95% confidence interval (CI) = 13.97%, 20.17%] than in the 4 weeks before 21 March almost entirely due to a drop in MME/day dispensed for prescriptions of ≤ 7 days. There was not a discernable drop in MOUD dispensing associated with the period of the emergency orders. CONCLUSIONS: New York State emergency orders in March 2020 to reduce SARS-CoV-2 transmission and preserve hospital capacity appeared to be associated with a decline in dispensing of opioids not used as MOUD. Access to MOUD appeared to be unaffected by the orders, probably because of policy initiatives by the Substance Abuse and Mental Health Services Administration.

Risk of Experiencing an Overdose Event for Patients Undergoing Treatment With Medication for Opioid Use Disorder.

OBJECTIVE: Overdose risk during a course of treatment with medication for opioid use disorder (MOUD) has not been clearly delineated. The authors sought to address this gap by leveraging a new data set from three large pragmatic clinical trials of MOUD. METHODS: Adverse event logs, including overdose events, from the three trials (N=2,199) were harmonized, and the overall risk of having an overdose event in the 24 weeks after randomization was compared for each study arm (one methadone, one naltrexone, and three buprenorphine groups), using survival analysis with time-dependent Cox proportional hazard models. RESULTS: By week 24, 39 participants had ≥1 overdose event. The observed frequency of having an overdose event was 15 (5.30%) among 283 patients assigned to naltrexone, eight (1.51%) among 529 patients assigned to methadone, and 16 (1.15%) among 1,387 patients assigned to buprenorphine. Notably, 27.9% of patients assigned to extended-release naltrexone never initiated the medication, and their overdose rate was 8.9% (7/79), compared with 3.9% (8/204) among those who initiated naltrexone. Controlling for sociodemographic and time-varying medication adherence variables and baseline substance use, a proportional hazard model did not show a significant effect of naltrexone assignment. Significantly higher probabilities of experiencing an overdose event were observed among patients with baseline benzodiazepine use (hazard ratio=3.36, 95% CI=1.76, 6.42) and those who either were never inducted on their assigned study medication (hazard ratio=6.64, 95% CI=2.12, 19.54) or stopped their medication after initial induction (hazard ratio=4.04, 95% CI=1.54, 10.65). CONCLUSIONS: Among patients with opioid use disorder seeking medication treatment, the risk of overdose events over the next 24 weeks is elevated among those who fail to initiate or discontinue medication and those who report benzodiazepine use at baseline.

Comorbidity burden and health-related quality of life in men with advanced prostate cancer.

Purpose: Identifying clinically relevant comorbidities and their effect on health-related quality of life (HRQoL) outcomes among men with advanced prostate cancer (APC) can inform patient care and improve outcomes; however, this is poorly understood. The aim of this observational study was to examine the prevalence of comorbidities, and the relationship of comorbidity burden to HRQoL and other patient-reported outcomes (PROs) among men with APC. Methods: Participants were 192 men (average age 68.8) with APC (stage III or IV) who completed a psychosocial battery including measures of sociodemographic factors, HRQoL and other PROs, and the Charlson Comorbidity Index (CCI). Hierarchical multiple regression analysis was used to examine the relationships between CCI, HRQOL, and PROs. Results: The vast majority (82%) of participants had at least one comorbidity, with the most common being: hypertension (59%), connective tissue disease or arthritis (31%), diabetes (24%), and problems with kidneys, vision, or another organ (24%). After controlling for covariates, regressions showed that a higher CCI score was significantly associated with worse HRQoL ( p < 0.001), lower levels of positive affect ( p < 0.05), and higher levels of depression ( p < 0.05), fatigue ( p < 0.001), pain ( p < 0.01), stress ( p < 0.01), and cancer-specific distress ( p < 0.05). Conclusions: Comorbidities were common among men with APC, and a greater CCI score was associated with detriments in several domains of HRQoL and other PROs. Our findings show the need to address comorbidities in the presence of a cancer diagnosis and subsequent treatment.