Socioecologic Factors and Racial Differences in Breast Cancer Multigene Prognostic Scores in US Women.

Importance: Disproportionately aggressive tumor biology among non-Hispanic Black women with early-stage, estrogen receptor (ER)-positive breast cancer contributes to racial disparities in breast cancer mortality. It is unclear whether socioecologic factors underlie racial differences in breast tumor biology. Objective: To examine individual-level (insurance status) and contextual (area-level socioeconomic position and rural or urban residence) factors as possible mediators of racial and ethnic differences in the prevalence of ER-positive breast tumors with aggressive biology, as indicated by a high-risk gene expression profile. Design, Setting, and Participants: This retrospective cohort study included women 18 years or older diagnosed with stage I to II, ER-positive breast cancer between January 1, 2007, and December 31, 2015. All data analyses were conducted between December 2022 and April 2023. Main Outcomes and Measures: The primary outcome was the likelihood of a high-risk recurrence score (RS) (≥26) on the Oncotype DX 21-gene breast tumor prognostic genomic biomarker. Results: Among 69 139 women (mean [SD] age, 57.7 [10.5] years; 6310 Hispanic [9.1%], 274 non-Hispanic American Indian and Alaskan Native [0.4%], 6017 non-Hispanic Asian and Pacific Islander [8.7%], 5380 non-Hispanic Black [7.8%], and 51 158 non-Hispanic White [74.0%]) included in our analysis, non-Hispanic Black (odds ratio [OR], 1.33; 95% CI, 1.23-1.43) and non-Hispanic American Indian and Alaska Native women (OR, 1.38; 95% CI, 1.01-1.86) had greater likelihood of a high-risk RS compared with non-Hispanic White women. There were no significant differences among other racial and ethnic groups. Compared with non-Hispanic White patients, there were greater odds of a high-risk RS for non-Hispanic Black women residing in urban areas (OR, 1.35; 95% CI, 1.24-1.46), but not among rural residents (OR, 1.05; 95% CI, 0.77-1.41). Mediation analysis demonstrated that lack of insurance, county-level disadvantage, and urban vs rural residence partially explained the greater odds of a high-risk RS among non-Hispanic Black women (proportion mediated, 17%; P < .001). Conclusions and Relevance: The findings of this cohort study suggest that the consequences of structural racism extend beyond inequities in health care to drive disparities in breast cancer outcome. Additional research is needed with more comprehensive social and environmental measures to better understand the influence of social determinants on aggressive ER-positive tumor biology among racial and ethnic minoritized women from disadvantaged and historically marginalized communities.

Implementation of virtual academic detailing in North America: A qualitative study.

RATIONALE: The shift toward virtual academic detailing (AD) was accelerated by the COVID-19 pandemic. AIMS AND OBJECTIVES: We aimed to examine the role of external, contextual, and intrinsic programme-specific factors in virtual engagement of healthcare providers (HCPs) and delivery of AD. METHODS: AD groups throughout North America were contacted to participate in semistructured interviews. An interview guide was constructed by adapting the Consolidated Framework for Implementation Research (CFIR). A point of emphasis included strategies AD groups employed for provider engagement while implementing virtual AD programmes. Independent coders conducted qualitative analysis using the framework method. RESULTS: Fifteen AD groups from Canada (n = 3) and the United States (n = 12) participated. Technological issues and training detailers and HCPs were challenges during the transition to virtual AD visits. Restrictions on in-person activities during the pandemic created difficulties engaging HCPs and fewer AD visits. Continuing education was one strategy to incentivize participation, but credits were often not claimed by HCPs. Groups with established networks and prior experience with virtual AD leveraged connections to mitigate disruptions and continue AD visits. Other facilitators included emphasizing contemporary topics, including opioid education beyond fundamental guidelines. Virtual AD had the additional benefit of expanding geographic reach and flexible scheduling with providers. CONCLUSIONS: AD groups across North America have shifted to virtual outreach and delivery strategies. This trend toward virtual AD may aid outreach to vulnerable rural communities, improving health equity. More research is needed on the effectiveness of virtual AD and its future implications.

Antiviral influenza treatments and hemorrhage-related adverse events in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.

STUDY OBJECTIVE: To determine whether there is a signal for gastrointestinal (GI) or intracranial (IC) hemorrhage associated with the use of antiviral medications for influenza in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. DESIGN: Disproportionality analysis. DATA SOURCE: The FAERS database was searched using OpenVigil 2.1 to identify GI and IC hemorrhage events reported between 2004 and 2022. MEASUREMENTS: Antiviral medications for influenza included the following: oseltamivir, zanamivir, peramivir, and baloxavir marboxil. Hemorrhage events were identified using Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries for GI and IC hemorrhages. Reporting odds ratios (RORs) were calculated to compare the occurrence of GI and IC hemorrhage events between antiviral drugs for influenza and (i) all other medications and (ii) antibiotics. RORs were also calculated for each of the individual antiviral medications. MAIN RESULTS: A total of 245 cases of GI hemorrhage and 23 cases of IC hemorrhage were identified in association with four antivirals. In comparison with all other drugs, the RORs of GI hemorrhage for oseltamivir, zanamivir, peramivir, baloxavir, and all antivirals combined were 1.17, 0.62, 4.44, 2.53, and 1.22, respectively, indicating potential variations in GI hemorrhage risk among the antivirals. In contrast, in comparison with all other drugs, the RORs of IC hemorrhage for oseltamivir (0.44), zanamivir (0.16), baloxavir (0.44), and all antivirals combined (0.41) were less than 1.0 which is consistent with no elevated risk of IC hemorrhage. CONCLUSION: In this study, some signals for GI hemorrhage were observed, particularly for peramivir and baloxavir marboxil. Further investigation is warranted to better understand and evaluate the potential risks of GI hemorrhage associated with antiviral treatments for influenza.

Pathologic complete response in patients with esophageal cancer receiving neoadjuvant chemotherapy or chemoradiation: A systematic review and meta-analysis.

BACKGROUND: Neoadjuvant chemoradiation and chemotherapy are recommended for the treatment of nonmetastatic esophageal cancer. The benefit of neoadjuvant treatment is mostly limited to patients who exhibit pathologic complete response (pCR). Existing estimates of pCR rates among patients receiving neoadjuvant therapy have not been synthesized and lack precision. METHODS: We conducted an independently funded systematic review and meta-analysis (PROSPERO CRD42023397402) of pCR rates among patients diagnosed with esophageal cancer treated with neoadjuvant chemo(radiation). Studies were identified from Medline, EMBASE, and CENTRAL database searches. Eligible studies included trials published from 1992 to 2022 that focused on nonmetastatic esophageal cancer, including the gastroesophageal junction. Histology-specific pooled pCR prevalence was determined using the Freeman-Tukey transformation and a random effects model. RESULTS: After eligibility assessment, 84 studies with 6451 patients were included. The pooled prevalence of pCR after neoadjuvant chemotherapy in squamous cell carcinomas was 9% (95% CI: 6%-14%), ranging from 0% to 32%. The pooled prevalence of pCR after neoadjuvant chemoradiation in squamous cell carcinomas was 32% (95% CI: 26%-39%), ranging from 8% to 66%. For adenocarcinoma, the pooled prevalence of pCR was 6% (95% CI: 1%-12%) after neoadjuvant chemotherapy, and 22% (18%-26%) after neoadjuvant chemoradiation. CONCLUSIONS: Under one-third of patients with esophageal cancer who receive neoadjuvant chemo(radiation) experience pCR. Patients diagnosed with squamous cell carcinomas had higher rates of pCR than those with adenocarcinomas. As pCR represents an increasingly utilized endpoint in neoadjuvant trials, these estimates of pooled pCR rates may serve as an important benchmark for future trial design.

Optimizing large real-world data analysis with parquet files in R: A step-by-step tutorial.

PURPOSE: The use of open-source programming languages can facilitate open science practices in real-world evidence (RWE) studies. Real-world studies often rely on using big data, which makes using such languages complicated. We demonstrate an efficient approach that enables RWE researchers to use R to undertake RWE analysis tasks from cohort building to reporting. METHODS: Using the Merative Marketscan data (2017-2019), we developed an R function to transform the data into parquet format to be used in R. Then, we compared the differences in data size before and after transformation. We compared the performance of the transformed data in R to the original data in terms of numerical consistency and running times required to complete simple exploratory tasks. To show how the transformed databases can be used in practice, we conducted a simplified replication of an active comparator new user study from the literature. All codes are available on GitHub. RESULTS: Our approach exhibited high efficiency in data storage, as evidenced by the converted data size, which ranged from 10% to 43% of that of the original data files. The runtime of the exploratory tasks in R generally outperformed that of the original data with SAS. We showed, through example, how the converted data can be efficiently used to implement an RWE study. CONCLUSION: We demonstrate a free and efficient solution to facilitate the use of open-source programming languages with big real-world databases, which can facilitate the adoption of open science practices.

Adherence and persistence of HIV pre-exposure prophylaxis use in the United States.

PURPOSE: To describe medication adherence and persistence of HIV PrEP overall and compare between sex and age groups of commercially insured individuals in the United States. METHODS: We conducted a national retrospective cohort study of the Merative MarketScan Claims Database from 2011 to 2019 to describe adherence and persistence of PrEP overall and compared between sex and age groups. High adherence was defined as ≥80% of proportion of days covered and persistence was measured in days from initiation to the first day of a 60-day treatment gap. RESULTS: A total of 29 689 new PrEP users identified. Overall adherence was high (81.9%; 95% confidence interval [CI]: 81.5%-82.3%). Females were more adherent than males (adjusted odds ratio [aOR] 1.87; 95% CI: 1.50-2.34), while those ≥45-years were less adherent than individuals <45-years (aOR 0.87: 95% CI: 0.81-0.93). More than half of individuals discontinued therapy within the first year (median 238.0 days; interquartile range 99.0-507.0 days). Females were less persistent than males (hazard ratio [HR] 1.49; 95% CI: 1.34-1.65), and people ≥45-years old were more persistent (i.e., lower risk of discontinuation) than those <45-years (HR 0.43; 95% CI: 0.33-0.55). CONCLUSIONS: These findings show adherence to daily PrEP is high among commercially insured individuals but the majority still discontinue in the first year. Future research should investigate what factors influence PrEP discontinuation among this population and ways to reduce barriers to therapy maintenance to ensure the population-level benefits of PrEP treatment.

Patterns of prescription opioid use and opioid-related harms among adult patients with hematologic malignancies.

INTRODUCTION: Treatment advances for hematologic malignancies (HM) have dramatically improved life expectancy, necessitating greater focus on long-term cancer pain management. This study explored real-world patterns of opioid use among patients with HM. METHODS: This retrospective cohort study identified adults diagnosed with HM from January 1, 2013 through December 31, 2019 using the Truven MarketScan Commercial Claims and Encounters database. Across several HM types, we described rates of high-risk opioid use (based on Pharmacy Quality Alliance measures) and opioid-related harms, including incident opioid use disorder (OUD) diagnoses and opioid-related hospitalizations or emergency department (ED) visits. We used multivariable Cox regression to generate adjusted hazard ratios and 95% confidence intervals comparing the risk of opioid-related harms between patients with versus without high-risk opioid use. RESULTS: Our sample included 43,190 patients with HM. Median age at HM diagnosis was 54 years (interquartile range = 44-60). Most patients (61.9%) were diagnosed with lymphoma. Approximately half (49.2%) had an opioid dispensed in the follow-up period. Among all patients, 20.0% met criteria for high-risk opioid use, 0.9% had an OUD diagnosis, and 0.3% experienced an opioid-related hospitalization/ED visit in follow-up. High-risk opioid use increased the risk of an OUD diagnosis by 3.3 times (p < 0.0001) and an opioid-related hospitalization/ED visit 4.2 times (p < 0.0001). CONCLUSION: High-risk opioid use was prevalent among patients with HM and significantly increased the risk of opioid-related harms. However, rates of opioid-related harms were low. These findings highlight the importance of continually monitoring pain and opioid use throughout HM survivorship to provide safe, effective HM pain management.

Trends in Outpatient Influenza Antiviral Use Among Children and Adolescents in the United States.

BACKGROUND: Influenza antivirals improve outcomes in children with duration of symptoms <2 days and those at high risk for influenza complications. Real-world prescribing of influenza antivirals in the pediatric population is unknown. METHODS: We performed a cross-sectional study of outpatient and emergency department prescription claims in individuals <18 years of age included in the IBM Marketscan Commercial Claims and Encounters Database between July 1, 2010 and June 30, 2019. Influenza antiviral use was defined as any dispensing of oseltamivir, baloxavir, or zanamivir. The primary outcome was the rate of antiviral dispensing per 1000 enrolled children. Secondary outcomes included antiviral dispensing per 1000 influenza diagnoses and inflation-adjusted costs of antiviral agents. Outcomes were calculated and stratified by age, acute versus prophylactic treatment, influenza season, and geographic region. RESULTS: The analysis included 1 416 764 unique antiviral dispensings between 2010 and 2019. Oseltamivir was the most frequently prescribed antiviral (99.8%). Dispensing rates ranged from 4.4 to 48.6 per 1000 enrolled children. Treatment rates were highest among older children (12-17 years of age), during the 2017 to 2018 influenza season, and in the East South Central region. Guideline-concordant antiviral use among young children (<2 years of age) at a high risk of influenza complications was low (<40%). The inflation-adjusted cost for prescriptions was $208 458 979, and the median cost ranged from $111 to $151. CONCLUSIONS: There is wide variability and underuse associated with influenza antiviral use in children. These findings reveal opportunities for improvement in the prevention and treatment of influenza in children.

Fanconi Syndrome in Patients With Human Immunodeficiency Virus Treated With Tenofovir-Based Antiretroviral Therapy: A Systematic Literature Review.

OBJECTIVE: Several cases of Fanconi syndrome (FS), a severe form of nephrotoxicity, have been reported in patients with HIV on tenofovir-containing antiretroviral therapy. A systematic review of the published literature on tenofovir-related FS in patients with HIV was conducted. DATA SOURCES: PubMed and Embase were queried to identify articles in English published between January 2005 and June 2023, reporting tenofovir-related FS in adults with HIV. Preclinical studies, conference/poster abstracts, commentaries and responses, and review papers were excluded. STUDY SELECTION AND DATA EXTRACTION: Of the 256 articles screened, 57 met the inclusion criteria. These comprised 37 case reports, 11 case series, 1 cross-sectional study, 1 case-control study, 4 cohort studies, 1 single-arm open-label clinical trial, 1 sub-analysis of clinical trials, and 1 pooled analysis of clinical trials. DATA SYNTHESIS: Among 56 cases on which information was abstracted, median age at FS diagnosis was 50 years, 51.8% were men, and duration of tenofovir use ranged from 6 weeks to 11 years. Ritonavir was co-prescribed in almost half the cases. In observational and interventional studies, incidence of FS was low. Many studies reported resolution of FS symptoms after tenofovir discontinuation. All FS occurrences were identified in those on tenofovir disoproxil fumarate (TDF), except for one patient on tenofovir alafenamide (TAF). RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Continuous monitoring of signs and symptoms of renal and bone toxicity is essential for patients with HIV on tenofovir-containing therapy. CONCLUSIONS: Occurrence of FS is low in patients with HIV treated with tenofovir-based regimens. Concomitant use of ritonavir may increase risk of FS. TAF may be a safer alternative than TDF in terms of nephrotoxicity.

A qualitative assessment of key considerations for drug checking service implementation.

BACKGROUND: With many drug-related deaths driven by potent synthetic opioids tainting the illicit drug supply, drug checking services are becoming a key harm reduction strategy. Many drug checking technologies are available, ranging from fentanyl test strips to mass spectrometry. This study aimed to identify key considerations when implementing drug checking technologies and services to support harm reduction initiatives. METHODS: Key informant interviews were conducted with harm reduction stakeholders throughout Illinois. Participants included members of existing drug checking services and recovery centers. Interviews were recorded, transcribed, and coded by two researchers using the framework method. Findings were contextualized according to micro (client)-, meso (organization)-, and macro (policy)-level themes. RESULTS: Seven interviews were conducted with ten participants. Fourier transform infrared spectroscopy was consistently identified as a technology of choice given its accuracy, range of substance detection, portability, and usability. Recommendations included the use of confirmatory testing, which can help address the limitations of technologies and provide a mechanism to train technicians. Locations of drug checking services should maximize public health outreach and leverage existing harm reduction agencies and staff with lived experience, who are critical to developing trust and rapport with clients. Criminalization and loss of privacy were major concerns for clients using drug checking services. Additional issues included the need to raise awareness of the legitimacy of services through public support from governing bodies, and funding to ensure the sustainability of drug checking services. CONCLUSIONS: This research facilitated the identification of issues and recommendations from stakeholders around key considerations for the adoption of drug checking technologies, which not only included the cost and technical specifications of instrumentation, but also broader issues such as accessibility, privacy, and well-trained personnel trusted by clients of the service. Successful implementation of drug checking services requires knowledge of local needs and capacity and an in-depth understanding of the target population.

Contextual factors affecting the implementation of drug checking for harm reduction: a scoping literature review from a North American perspective.

BACKGROUND: The opioid epidemic continues to be a significant cause of morbidity and mortality in the US. In 2020, 83% of opioid-related overdose deaths were due to synthetic opioids, such as fentanyl. Drug checking services have been widely implemented as a harm reduction intervention to facilitate the identification of substances in a drug sample. There is a need to inform decision-making on drug checking technologies and service implementation. This research aims to outline contextual considerations for the implementation of a drug checking service. METHODS: A scoping review was conducted using a structured search strategy in PubMed and EMBASE. Articles were independently screened by two reviewers, and included if they were primary literature and reported on an actionable consideration(s) for drug checking services. Data elements were extracted using a standardized form, and included study design, study population, drug checking technology utilized or discussed, and main findings. RESULTS: Twenty-nine articles were selected for inclusion, and four primary areas of consideration were identified: drug checking technologies, venue of a drug checking service, legality, and privacy. Technological considerations include the need for highly accurate, quantitative results which appeal to both populations of people with drug use disorder and recreational users. Accessibility of services was identified as an important factor that may be impacted by the location, integration with other services, how the service is provided (mobile vs. fixed), and the hours of operation. Maintaining plausible deniability and building trust were seen as important facilitators to service use and engagement. Issues surrounding legality were the most frequently cited barrier by patrons, including fear of criminalization, policing, and surveillance. Patrons and stakeholders identified a need for supportive policies that offer protections. Maintaining anonymity for patrons is crucial to addressing privacy-related barriers. CONCLUSION: This review highlights the need to understand the local population and climate for drug checking to implement a drug checking service successfully. Common themes identified in the literature included considerations related to the choice of technology, the type of venue, and the impact of legality and privacy. We intend to utilize these considerations in future research to help guide discussions with US-based stakeholders.

Trends of nonoccupational postexposure prophylaxis in the United States.

OBJECTIVE: To describe national annual rates of nonoccupational postexposure prophylaxis (nPEP) in the United States. DESIGN: Retrospective cohort study of commercially insured individuals in the Merative MarketScan Database from January 1, 2010 to December 31, 2019. METHODS: Patients at least 13 years old prescribed nPEP per recommended Centers for Disease Control and Prevention guidelines were identified using pharmacy claims. Rates of use were described overall and stratified by sex, age group, and region. These rates were qualitatively compared to the diagnosis rates of human immunodeficiency virus (HIV) observed in the data. Joinpoint analysis identified inflection points of nPEP use. RESULTS: Eleven thousand, three hundred and ninety-seven nPEP users were identified, with a mean age of 33.7 years. Most were males (64.6%) and lived in the south (33.2%) and northeast (32.4%). The rate of nPEP use increased 515%, from 1.42 nPEP users per 100 000 enrollees in 2010 to 8.71 nPEP users per 10 000 enrollees in 2019. The comparative nPEP use rates among subgroups largely mirrored their HIV diagnosis rates, that is, subgroups with a higher HIV rate had higher nPEP use. In the Joinpoint analysis significant growth was observed from 2012 to 2015 [estimated annual percentage change (EAPC): 45.8%; 95% confidence interval (CI): 29.4 - 64.3] followed by a more moderate increase from 2015 to 2019 (EAPC 16.0%; 95% CI: 12.6-19.6). CONCLUSIONS: nPEP use increased from 2010 to 2019, but not equally across all risk groups. Further policy interventions should be developed to reduce barriers and ensure adequate access to this important HIV prevention tool.

Evaluating the use of methods to mitigate bias from non-transient medications in the case-crossover design: A systematic review.

PURPOSE: The case-crossover design is a self-controlled study design used to compare exposure immediately preceding an event occurrence with exposure in earlier control periods. The design is most suitable for transient exposures in order to avoid biases that can be problematic when using the case-crossover design for non-transient (i.e., chronic) exposures. Our goal was to conduct a systematic review of case-crossover studies and its variants (case-time-control and case-case-time-control) in order to compare design and analysis choices by medication type. METHODS: We conducted a systematic search to identify recent case-crossover, case-time-control, and case-case-time-control studies focused on medication exposures. Articles indexed in MEDLINE and EMBASE using these study designs that were published between January 2015 and December 2021 in the English language were identified. Reviews, methodological studies, commentaries, articles without medications as the exposure of interest, and articles with no available full text were excluded. Study characteristics including study design, outcome, risk window, control window, reporting of discordant pairs, and inclusion of sensitivity analyses were summarized overall and by medication type. We further evaluated the implementation of recommended methods to account for biases introduced by non-transient exposures among articles that used the case-crossover design on a non-transient exposure. RESULTS: Of the 2036 articles initially identified, 114 articles were included. The case-crossover was the most common study design (88%), followed by the case-time-control (17%), and case-case-time-control (3%). Fifty-three percent of the articles included only transient medications, 35% included only non-transient medications, and 12% included both. Across years, the proportion of case-crossover articles evaluating a non-transient medication ranged from 30% in 2018 to 69% in 2017. We found that 41% of the articles that evaluated a non-transient medication did not apply any of the recommended methods to account for biases and more than half of which were conducted by authors with no previous publication history of case-crossover studies. CONCLUSION: Using the case-crossover design to evaluate a non-transient medication remains common in pharmacoepidemiology. Researchers should apply appropriate design and analysis choices when opting to use a case-crossover design with non-transient medication exposures.

Risk prediction models for antineoplastic-associated cardiotoxicity in treatment of breast cancer: A systematic review.

PURPOSE: The objective of this systematic review is to assess methodology of published models to predict the risk of antineoplastic-associated cardiotoxicity in patients with breast cancer. METHODS: We searched PubMed and Embase for studies that developed or validated a multivariable risk prediction model. Data extraction and quality assessments were performed according to the Prediction Model Risk of Bias Assessment Tool (PROBAST). RESULTS: We identified 2,816 unique publications and included 8 eligible studies (7 new risk models and 1 validation of a risk stratification tool) that modeled risk with trastuzumab (n = 5), anthracyclines (n = 2), and anthracyclines with or without trastuzumab (n = 1). The most common final predictors were previous or concomitant chemotherapy (n = 5) and age (n = 4). Three studies incorporated measures of myocardial mechanics that may not be frequently available. Model discrimination was reported in 7 studies (range of area under the receiver operating characteristic curve, 0.56-0.88), while calibration was reported in 1 study. Internal and external validation were performed in 4 studies and 1 study, respectively. Using the PROBAST methodology, we rated the overall risk of bias as high for 7 of 8 studies and unclear for 1 study. Concerns for applicability were low for all studies. CONCLUSION: Among 8 models to predict the risk of cardiotoxicity of antineoplastic agents for breast cancer, 7 were rated as having a high risk of bias and all had low concerns for clinical applicability. Most evaluated studies reported positive measures of model performance but did not perform external validation. Efforts to improve development and reporting of these models to facilitate their use in practice are warranted.

Comparison of Preferences and Data Quality between Discrete Choice Experiments Conducted in Online and Face-to-Face Respondents.

INTRODUCTION: Discrete choice experiments (DCE) are increasingly being conducted using online panels. However, the comparability of such DCE-based preferences to traditional modes of data collection (e.g., in-person) is not well established. In this study, supervised, face-to-face DCE was compared with its unsupervised, online facsimile on face validity, respondent behavior, and modeled preferences. METHODS: Data from face-to-face and online EQ-5D-5L health state valuation studies were compared, in which each used the same experimental design and quota sampling procedure. Respondents completed 7 binary DCE tasks comparing 2 EQ-5D-5L health states presented side by side (health states A and B). Data face validity was assessed by comparing preference patterns as a function of the severity difference between 2 health states within a task. The prevalence of potentially suspicious choice patterns (i.e., all As, all Bs, and alternating As/Bs) was compared between studies. Preference data were modeled using multinomial logit regression and compared based on dimensional contribution to overall scale and importance ranking of dimension-levels. RESULTS: One thousand five Online respondents and 1,099 face-to-face screened (F2FS) respondents were included in the main comparison of DCE tasks. Online respondents reported more problems on all EQ-5D dimensions except for Mobility. The face validity of the data was similar between comparators. Online respondents had a greater prevalence of potentially suspicious DCE choice patterns ([Online]: 5.3% [F2FS] 2.9%, P = 0.005). When modeled, the relative contribution of each EQ-5D dimension differed between modes of administration. Online respondents weighed Mobility more importantly and Anxiety/Depression less importantly. DISCUSSION: Although assessments of face validity were similar between Online and F2FS, modeled preferences differed. Future analyses are needed to clarify whether differences are attributable to preference or data quality variation between modes of data collection.

Adherence to HIV Pre-Exposure Prophylaxis Testing Guidelines in the United States.

Testing guidelines for initiation of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) have been developed to ensure appropriate use of PrEP, such as among those with renal dysfunction or at high risk of seroconversion. While many studies have looked at the trends of use of PrEP in the United States, little is known about compliance with these guidelines, the quality of care of PrEP at a national level, or what provider-level factors are associated with high-quality care. We conducted a retrospective claims analysis of providers of commercially insured new users of PrEP between January 1, 2011, and December 31, 2019. Of the 4200 providers, quality of care was low, with only 6.4% having claims for ≥60% of guideline-recommended testing for their patients in the testing window for all visits. More than half of the providers did not have claims for HIV testing at initiation of PrEP and ≥40% did not for sexually transmitted infections at both initiation and follow-up visits. Even when extending the testing window, quality of care remained low. Logistic regression models found no association between provider type and high quality of care, but did find that providers with one PrEP patient were more likely to have higher quality of care than those with multiple patients for all tests [adjusted odds ratio 0.47 (95% confidence interval: 0.33-0.67)]. The study findings suggest further training and interventions, such as integrated test ordering through electronic health records, are needed to increase quality of care for PrEP and ensure appropriate monitoring of patients.

Perceptions of prescription opioids among marginalized patients with hematologic malignancies in the context of the opioid epidemic: a qualitative study.

PURPOSE: Opioids are essential for treating pain in hematologic malignancies (HM), yet are heavily stigmatized in the era of the opioid epidemic. Stigma and negative attitudes towards opioids may contribute to poorly managed cancer pain. We aimed to understand patient attitudes towards opioids for HM pain management, particularly among historically marginalized populations. METHODS: We interviewed a convenience sample of 20 adult patients with HM during outpatient visits at an urban academic medical center. Semi-structured interviews were audio-recorded, transcribed, and qualitatively analyzed using the framework method. RESULTS: Among 20 participants, 12 were female and half were Black. Median age was 62 (interquartile range = 54-68). HM diagnoses included multiple myeloma (n = 10), leukemia (n = 5), lymphoma (n = 4), and myelofibrosis (n = 1). Eight themes emerged from interviews that seemed to influence HM-related pain self-management, including (1) fear of opioid-related harms, (2) opioid side effects and harms to health, (3) fatalism and stoicism, (4) perceived value of opioids for HM-related pain, (5) low perceived susceptibility to opioid-related harms and externalizing blame, (6) preferences for non-opioid pain management approaches, (7) trust in providers and opioid accessibility, and (8) external sources of pain management support and information. CONCLUSIONS: This qualitative study demonstrates that fears and stigmatized views of opioids can conflict with marginalized patients' needs to manage debilitating HM-related pain. Negative attitudes towards opioids were shaped by the opioid epidemic and reduced willingness to seek out or use analgesics. IMPLICATIONS FOR CANCER SURVIVORS: These findings help expose patient-level barriers to optimal HM pain management, revealing attitudes, and knowledge to be targeted by future pain management interventions in HM.

Pharmacists and Naloxone: Barriers to Dispensing and Effectiveness of an Educational Outreach Program.

BACKGROUND: The Illinois Naloxone Standing Order allows community pharmacists to dispense naloxone; however, this policy initiative may be underutilized. OBJECTIVE: Our study aims to characterize naloxone dispensing barriers, overall and by pharmacy type, make recommendations that can inform future policies to improve naloxone access, and evaluate outreach initiative effectiveness from academic detailers' perspectives. METHODS: We conducted a retrospective analysis of semistructured data collected as part of an educational outreach program targeting Illinois community pharmacists in 2021. Academic detailers conducted educational outreach visits across community pharmacy settings (i.e., primary pharmacy, grocery pharmacy, or independent pharmacy) to promote standing order use and discuss barriers pharmacists face when dispensing naloxone. Following each visit, detailers recorded visit characteristics, pharmacist-identified obstacles impacting naloxone dispensing, and visit effectiveness. RESULTS: Detailers performed in-person visits at 270 (78%) of 348 targeted sites. A lower proportion of independent pharmacies (61%) routinely stock naloxone than primary (95%, P < 0.001) or grocery (98%, P < 0.001) pharmacies. Among pharmacists at independent pharmacies, 43% indicated they were highly or extremely comfortable dispensing naloxone, a significantly lower proportion than pharmacists at grocery (79%, P < 0.001) or primary (68%, P < 0.001) pharmacies. The prevalence of salient barriers to naloxone dispensing was: cost/insurance issues (primary pharmacy = 38% vs. grocery pharmacy = 36% vs. independent pharmacy = 28%, P = 0.46), stigma (36% vs. 49% vs. 16%, P < 0.05), and lack of standing order enrollment (0% vs. 0% vs. 49%, P < 0.05). On average, detailers perceived visits as less useful to pharmacists working at independent pharmacies than those at primary or grocery pharmacies. CONCLUSIONS: Over 80% of pharmacists reported facing greater than one naloxone dispensing barrier. While cost/insurance issues appear ubiquitous, patient stigma-related factors were prevalent in primary and grocery pharmacies. Although many pharmacists are comfortable dispensing naloxone under the standing order, pharmacists at independent pharmacies are less comfortable, potentially secondary to lower standing order enrollment.

Sustained Virologic Response Rates Before and After Removal of Sobriety Restriction for Hepatitis C Virus Treatment Access.

OBJECTIVES: Until November 1, 2018, Illinois Medicaid restricted coverage of hepatitis C virus (HCV) medication to patients with sobriety from alcohol and illicit substances for ≥12 months. This policy limited treatment access for patients with a high risk of HCV transmission, despite clinical trial and real-world data demonstrating high sustained virologic response (SVR) rates among patients with substance use. The objective of this study was to compare HCV SVR rates between patients treated before and after removal of the Illinois Medicaid sobriety restriction. METHODS: We performed a retrospective cohort study of Medicaid-insured patients who completed direct-acting antiviral treatment at an urban, academic medical center in Illinois from January 1, 2014, through October 21, 2020. The primary endpoint was SVR. We compared group characteristics using χ2 or Fisher exact tests for categorical variables and Wilcoxon rank-sum tests for continuous variables. We used logistic regression to compare SVR rates before and after the policy change, adjusting for differences between groups. RESULTS: A total of 496 patients (348 pre-policy change; 148 post-policy change) started treatment; excluding loss to follow-up/early discontinuation, SVR rates were 95.4% (309 of 324) pre-policy change and 97.1% (134 of 138) post-policy change. SVR rates did not differ after adjusting for the use of historic HCV regimens and the higher cirrhosis rate in the pre-policy change group compared with the post-policy change group (odds ratio = 0.98; 95% CI, 0.32-3.67). CONCLUSION: HCV SVR rates were similar before and after removal of the Illinois Medicaid sobriety restriction, regardless of group differences. Results support HCV treatment regardless of documented sobriety to facilitate progress toward HCV elimination.

Design of the Reducing Diagnostic Error to Improve Patient Safety (REDEfINE) in COPD and asthma study: A cluster randomized comparative effectiveness trial.

Although spirometry is a simple, portable test and recommended for the diagnosis of asthma and chronic obstructive pulmonary disease (COPD), it is not routinely used in the primary care setting. Minorities and underserved populations are less likely to have spirometry assessment, leading to both over and misdiagnosis of asthma and COPD. Because dyspnea is a common symptom across multiple diseases, use of spirometry as a diagnostic tool is important. Missed, delayed, or misdiagnosis of asthma and COPD, which are considered diagnostic errors (DE), can lead to poor quality of care, increased morbidity and mortality, and increased costs to patients and health systems. Barriers to the use of spirometry have been identified at clinician/clinic and health systems levels. The REDEFINE program is designed to overcome identified barriers to spirometry use in primary care by utilizing health promoters (HPs) who perform spirometry within primary care clinics and work collaboratively with clinicians to incorporate the results at the point of care without interrupting clinic workflow. The REDEFINE trial is a comparative effectiveness study comparing outcomes of the REDEFINE program with usual care (UC) in primary care patients determined to be at increased risk of DE for asthma and COPD. The primary outcome will be all-cause hospitalizations. The secondary outcomes will be the proportion of accurate diagnosis of COPD, asthma, or asthma-COPD overlap based on initial diagnosis and spirometry and all cause and respiratory-related acute outpatient care and emergency department visits. In this report, we describe the design and methods for the REDEFINE trial. Trial registration: NCT03137303https://clinicaltrials.gov/ct2/show/NCT03137303?term=REDEFINE&draw=2&rank=1.