National Long-Term Trends in Postoperative Opioid Prescribing in Ambulatory Urology Procedures.

INTRODUCTION: With more than 60% of urological procedures performed in ambulatory settings, it is imperative to understand the current trends in postoperative narcotic prescriptions and their adherence to the guidelines. We studied postoperative opioid-prescribing patterns after selected common urology ambulatory procedures. METHODS: A retrospective cohort was derived from a 10% random sample of enrollees within the IQVIA PharMetrics Plus for Academics database from 2015 to 2021. Patient-level baseline characteristics were collected in the year preceding the index date. Descriptive and bivariate analyses were used to compare patient characteristics from opioid and nonopioid cohorts and those who utilized opioids ≤ 7 days and > 7 days postprocedurally. Trends of opioid and nonopioid use were also investigated and compared. RESULTS: Between 2015 to 2021, 17,817 patients underwent urological ambulatory procedures, of which the majority (90.9%) were endoscopic procedures. Of those, 4077 (22%) were prescribed opioids and 978 (5.4%) patients were given prescription nonopioid (ie, ketorolac) medication. From 2015 to 2021, there was an overall decrease in prescription of opioids from 32% to 19%. The acute fulfillment (within 7 days of the procedure) of opioids had notably declined; however, there is a slight increase in the fulfillment of opioids beyond 7 days. CONCLUSIONS: Within the 7-day postsurgical period after ambulatory procedures, narcotic prescribing habits among urologists are congruent with current initiatives to reduce narcotic use in the setting of the opioid pandemic. However, beyond the 7-day postsurgical period, further guidelines are needed to guide narcotic prescribing habits.

Telehealth Utilization for Opioid Use Disorder: A Nationwide Analysis Before and After the COVID-19 Public Health Emergency Declaration.

Introduction: The COVID-19 pandemic has led to the rapid and widespread adoption of telehealth services. Telehealth may aid in bridging gaps in access to care. The specific impact of telehealth on opioid use disorder (OUD) and its treatment remains uncertain. Methods: A retrospective review of commercial insurance claim records within the United States was conducted to investigate the association between the COVID-19 pandemic and changes in the rates of(a) OUD treatments with and without telehealth support and (b) prescriptions for medications for opioid use disorder (MOUD) with and without telehealth support among individuals diagnosed with OUD. Results: In a study population of 1,340,506 individuals, OUD diagnosis rates were 5 per 1,000 in-person and 1 per 1,000 via telehealth. COVID-19 decreased in-person OUD diagnoses by 0.89 per 1,000, while telehealth diagnoses increased by 0.83 per 1,000. In-person MOUD treatment rates increased by 0.07 per 1,000 during COVID-19, while telehealth rates remained low. The onset of COVID-19 saw a 1.13 per 1,000 higher increase in telehealth-supported MOUD treatment compared to solely in-person treatment. Conclusions: A retrospective review of commercial insurance claim records within the United States was conducted to investigate the association between the COVID-19 pandemic and changes in the rates of (a) OUD treatments with and without telehealth support and (b) prescriptions for MOUD with and without telehealth support among individuals diagnosed with OUD.

Association of race/ethnicity and patient care experiences with healthcare utilization and healthcare costs among prostate cancer survivors: A SEER-CAHPS study.

INTRODUCTION: This study aimed to evaluate the association of race/ethnicity and patient care experiences (PCEs) with healthcare utilization and costs among US older adults with prostate cancer (PCa). MATERIALS AND METHODS: The study used data from 2007 to 2015 Surveillance, Epidemiology, and End Results dataset linked to Medicare Consumer Assessment of Healthcare Providers and Systems survey and Medicare claims (SEER-CAHPS). We identified males aged ≥65 years who completed a CAHPS survey within 6-60 months post-PCa diagnosis. Covariate-adjusted associations of six CAHPS PCE composite measures with any emergency department visit and any inpatient stay (using logistic regressions), and with total part A and part B Medicare costs (using generalized linear models) were examined by race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic, non-Hispanic Asian, and other). RESULTS: Among 1834 PCa survivors, a 1-point higher score for getting care quickly was associated with higher odds (odds ratio 1.08; 95% confidence interval [CI]: 1.02-1.15; p = 0.009) of any inpatient stay in Hispanic patients. Higher total costs were associated with a 1-point higher score for getting needed care among Hispanic patients ($590.84; 95% CI: $262.15, $919.53; p < 0.001); a 1-point higher score for getting care quickly among Hispanic patients ($405.26; 95% CI: $215.83, $594.69; p < 0.001); and a 1-point higher score for customer service among patients belonging to other races ($361.69; 95% CI: $15.68, $707.69; p = 0.04). DISCUSSION: We observed differential associations by race/ethnicity between PCEs and healthcare utilization and costs. Further research is needed to explore the causes of these associations.

Identifying Risk Factors for Cardiovascular Events Among Active-Duty Service Members and Veterans Prescribed Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).

Background: Oral NSAIDs are widely used analgesic medications for the treatment of musculoskeletal and inflammatory conditions. NSAIDs are associated with adverse effects that arise from COX enzyme inhibition including cardiovascular events. The combined role of patient and prescription factors associated with NSAID use on cardiovascular risk is not well characterized. Objective: The purpose of this study is to identify the risk factors with cardiovascular events among NSAID users. Methods: This study is a retrospective, nested case-control study, within the DAVINCI database, among active-duty service members and veterans with at least one NSAID pharmacy claim between fiscal year (FY) 2015-FY2020. Inclusion criteria individuals ≥18 years of age received a prescription NSAID for ≥7-day supply and a duration ≥1 month overall. Cases experienced nonfatal myocardial infarction, nonfatal stroke, or new onset heart failure. Ten controls were selected per case. Risk factors were identified through logistic regression modeling. Results: The risk factors with strongest association to the primary outcome included age starting at 45 up to 75 and older, the first 90 days of NSAID exposure, cerebrovascular disease, cardiomyopathy, and history of myocardial infarction. Cox-selectivity and dose did not appear to be clinically significant in their association with cardiovascular events. Conclusion: The results of this study indicate that age, initial NSAID exposure, and comorbidities are more predictive than NSAID-specific factors such as COX-selectivity and dose. The results provide the framework for development of a risk score to improve prediction of NSAID-associated cardiovascular events.

Medication Trends in the Military: A Comparative Analysis of Prescribing Patterns Among Service Members Seen by a Pharmacist and Implications for Medical Readiness.

INTRODUCTION: Medications play a critical role supporting the health of military service members. Little is known about the broad use of medications prescribed to this population. Active duty service members (ADSMs), while often younger and having fewer diagnosed comorbid conditions, face unique health challenges that benefit from pharmacotherapy. Understanding prescribing patterns is instrumental to illuminate potential areas for research and to guide education so that military health care professionals can maintain competency, improve outcomes, and support medical readiness. This study aimed to characterize commonly dispensed medications among ADSMs and to compare these prescriptions with those of the general population. MATERIALS AND METHODS: A retrospective, cross-sectional analysis using data extracted contained in the Military Health System Information Platform focused on ADSMs who consulted with a clinical pharmacist during the 2019 fiscal year. Descriptive statistics were used to summarize patient and prescription data. The 100 most frequently prescribed medications and 20 most frequently prescribed therapeutic classes were identified. Analyses were performed using Statistical Analysis System (SAS) software, and a non-metric multidimensional scaling plot was generated in R to illustrate the relationships between the 20 most frequently used therapeutic classes and the branches of service. RESULTS: The study analyzed 719,788 prescriptions for 30,012 service members, revealing a high prescription rate for pain, inflammation, and psychiatric condition treatments. Antidepressants and nonsteroidal anti-inflammatory drugs were among the most commonly prescribed across all military branches. Some medication uses varied, which may indicate distinct needs within different service branches. CONCLUSIONS: Understanding medication patterns among ADSMs may be able to help health care professionals proactively address pharmacological challenges and optimize pharmaceutical use in this unique population. This knowledge can also aid in the development of training modules focused on medication side effects, interactions, counseling, and implications on military deployment for the most commonly used medications. Future examination into prescribing cascades and medication use related to proton-pump inhibitors, docusate, benzonatate, and muscle relaxants may identify opportunities to provide better care or lower cost.

Development and Testing of a Chronic-Disease Patient Experience Mapping Toolbox.

BACKGROUND: Stakeholders increasingly expect research and care delivery to be guided by and to optimize patient experiences. However, standardized tools to engage patients to gather high-quality data about their experiences, priorities, and desired outcomes are not publicly available. The objective of this study was to develop and test a Toolbox with a disease-agnostic interview guide template and accompanying resources to assist researchers in engaging patients living with chronic disease in a dialogue about their experiences. METHODS: Guided by a multidisciplinary workgroup, a targeted literature review (PubMed) was conducted, followed by group discussions to identify/thematically organize patient experience concepts, development of a conceptual model, and drafting of an interview guide template and patient-facing visual. Materials were tested/refined via cognitive (n = 5) and pilot (n = 30) interviews conducted virtually with US patients diagnosed with chronic/potentially disabling conditions from December 2020 to April 2021. Patient-facing tools were reviewed by health literacy experts for applicability/accessibility. English-speaking adults who self-reported receiving a chronic condition diagnosis at least 6 months prior participated in a 60-90 min interview. RESULTS: Patient experience concepts were organized thematically under three domains: (1) life before a diagnosis, (2) experiences getting a diagnosis, and (3) experiences living with a diagnosis. A plain language consent sheet template, interview guide template, and patient experience conceptual model were developed and revised based on input from interviewees, interviewers, and the workgroup. CONCLUSIONS: A disease-agnostic patient-engagement Toolbox was developed and tested to capture patient experience data. These materials can be customized based on study objectives and leveraged by various stakeholders to identify opportunities to enhance the patient centricity of healthcare delivery and research.

Patient-centeredness and psychometric properties of the Defense and Veterans Pain Rating Scale 2.0 (DVPRS).

OBJECTIVE: This study aims to assess the patient-centeredness and psychometric properties of the Defense and Veterans Pain Rating Scale 2.0 (DVPRS) as a patient-reported outcome measure (PROM) for pain assessment in a military population. DESIGN: A critical evaluation of the DVPRS was conducted, considering its fit-for-purpose as a PROM and its patient-centeredness using the National Health Council's Rubric to Capture the Patient Voice. SETTING: The study focused on the use of the DVPRS within the Department of Defense (DoD) and Veterans Health Administration (VA) healthcare settings. SUBJECTS: The DVPRS was evaluated based on published studies and information provided by measure developers. The assessment included content validity, reliability, construct validity, and ability to detect change. Patient-centeredness and patient engagement were assessed across multiple domains. METHODS: Two independent reviewers assessed the DVPRS using a tool/checklist/questionnaire, and any rating discrepancies were resolved through consensus. The assessment included an evaluation of psychometric properties and patient-centeredness based on established criteria. RESULTS: The DVPRS lacked sufficient evidence of content validity, with no patient involvement in its development. Construct validity was not assessed adequately, and confirmatory factor analysis was not performed. Patient-centeredness and patient engagement were also limited, with only a few domains showing meaningful evidence of patient partnership. CONCLUSIONS: The DVPRS as a PROM for pain assessment in the military population falls short in terms of content validity, construct validity, and patient-centeredness. It requires further development and validation, including meaningful patient engagement, to meet current standards and best practices for PROMs.

Association of race/ethnicity and patient care experiences with receipt of definitive treatment among prostate cancer survivors: a SEER-CAHPS study.

PURPOSE: This study aimed to evaluate the association of race/ethnicity, patient care experiences (PCEs), and receipt of definitive treatment and treatment modality among older adults in the United States (US) with localized prostate cancer (PCa). METHODS: Using Surveillance, Epidemiology and End Results dataset linked to Medicare Consumer Assessment of Healthcare Providers and Systems (SEER-CAHPS) for 2007-2015, we identified men aged ≥ 65 years who completed a CAHPS survey within one year before and one year after PCa diagnosis. Associations of race/ethnicity (non-Hispanic White (NHW), non-Hispanic Black (NHB), Hispanic, non-Hispanic Asian (NHA), and other) and of interactions between race/ethnicity and PCEs (getting needed care, getting care quickly, doctor communication, and care coordination) with the receipt of definitive PCa treatment and treatment modality within 3 and 6 months of diagnosis were examined using logistic regressions. RESULTS: Among 1,438 PCa survivors, no racial/ethnic disparities in the receipt of definitive treatment were identified. However, NHB patients were less likely to receive surgery (vs. radiation) within 3 and 6 months of PCa diagnosis than NHW patients (OR 0.397, p = 0.006 and OR 0.419, p = 0.005), respectively. Among NHA patients, a 1-point higher score for getting care quickly was associated with lower odds (OR 0.981, p = 0.043) of receiving definitive treatment within 3 months of PCa diagnosis, whereas among NHB patients, a 1-point higher score for doctor communication was associated with higher odds (OR 1.023, p = 0.039) of receiving definitive treatment within 6 months of PCa diagnosis. DISCUSSION: We observed differential associations between PCEs and receipt of definitive treatment based on patient race/ethnicity. Further research is needed to explore these associations.

Venous Access: National Guideline and Registry Development (VANGUARD): Advancing Patient-Centered Venous Access Care Through the Development of a National Coordinated Registry Network.

There are over 8 million central venous access devices inserted each year, many in patients with chronic conditions who rely on central access for life-preserving therapies. Central venous access device-related complications can be life-threatening and add tens of billions of dollars to health care costs, while their incidence is most likely grossly mis- or underreported by medical institutions. In this communication, we review the challenges that impair retention, exchange, and analysis of data necessary for a meaningful understanding of critical events and outcomes in this clinical domain. The difficulty is not only with data extraction and harmonization from electronic health records, national surveillance systems, or other health information repositories where data might be stored. The problem is that reliable and appropriate data are not recorded, or falsely recorded, at least in part because policy, payment, penalties, proprietary concerns, and workflow burdens discourage completeness and accuracy. We provide a roadmap for the development of health care information systems and infrastructure that address these challenges, framed within the context of research studies that build a framework of standardized terminology, decision support, data capture, and information exchange necessary for the task. This roadmap is embedded in a broader Coordinated Registry Network Learning Community, and facilitated by the Medical Device Epidemiology Network, a Public-Private Partnership sponsored by the US Food and Drug Administration, with the scope of advancing methods, national and international infrastructure, and partnerships needed for the evaluation of medical devices throughout their total life cycle.

The association of major adverse limb events and combination stent and atherectomy in patients undergoing revascularization for lower extremity peripheral artery disease.

BACKGROUND: The effectiveness of combined atherectomy and stenting relative to use of each procedure alone for the treatment of lower extremity peripheral artery disease has not been evaluated. AIMS: The objective of this study was to evaluate the short- and long-term major adverse limb event (MALE) following the receipt of stenting, atherectomy, and the combination of stent and atherectomy. METHODS: A retrospective cohort of patients undergoing atherectomy, stent, and combination stent atherectomy for lower extremity peripheral artery disease was derived from the Vascular Quality Initiative (VQI) data set. The primary outcome was MALE and was assessed in the short-term and long-term. Short-term MALE was assessed immediately following the procedure to discharge and estimated using logistic regression. Long-term MALE was assessed after discharge to end of follow-up and estimated using the Fine-Gray subdistribution hazard model. RESULTS: Among the 46,108 included patients, 6896 (14.95%) underwent atherectomy alone, 35,774 (77.59%) received a stent, and 3438 (7.5%) underwent a combination of stenting and atherectomy. The adjusted model indicated a significantly higher odds of short-term MALE in the atherectomy group (OR = 1.35; 95% confidence interval [CI]:1.16-1.57), and not significantly different odds (OR = 0.93; 95% CI:0.77-1.13) in the combination stent and atherectomy group when compared to stenting alone. With regard to long-term MALE, the model indicated that the likelihood of experiencing the outcome was slightly lower (HR = 0.90; 95% CI:0.82-0.98) in the atherectomy group, and not significantly different (HR = 0.92; 95% CI:0.82-1.04) in the combination stent and atherectomy group when compared to the stent group. CONCLUSIONS: Patients in the VQI data set who received combination stenting and atherectomy did not experience significantly different rates of MALE when compared with stenting alone. It is crucial to consider and further evaluate the influence of anatomical characteristics on treatment strategies and potential differential effects of comorbidities and other demographic factors on the short and long-term MALE risks.

Differences in racial/ethnic disparities in patient care experiences between prostate cancer survivors and males without cancer: A SEER-CAHPS study.

INTRODUCTION: Our purpose was to evaluate whether racial/ethnic disparities in patient care experiences (PCEs) differ between males with prostate cancer ("PCa group") and males without cancer ("non-cancer group"). MATERIALS AND METHODS: This retrospective study used 2007-2015 National Cancer Institute's Surveillance, Epidemiology and End Results registry data linked to Consumer Assessment of Healthcare Providers and Systems surveys. PCa and non-cancer groups were propensity score matched 1:5 on demographic and clinical characteristics. Differences in racial/ethnic disparities (DRD) (non-Hispanic Black [NHB], Hispanic, non-Hispanic Asian [NHA], and Other Races compared to non-Hispanic White [NHW]) in PCEs (getting needed care, getting care quickly, doctor communication, customer service, and getting needed prescription drugs) were compared between matched PCa and non-cancer groups. Per prior literature, DRD in PCE scores were categorized as small (<3), medium (≥3 but <5) or large (≥5). RESULTS: There were 7312 males in the PCa group and 36,559 matched males in the non-cancer group. Within each group, all racial/ethnic minority categories reported worse scores compared to NHW individuals (p < 0.05) for ≥3 PCE composite measures. Compared to PCa group, a larger NHA-NHW difference was observed in non-cancer group for getting needed care (-4.65 in PCa vs. -7.77 in non-cancer; DRD = 3.11, p = 0.029) and doctor communication (-2.46 in PCa vs. -4.85 in non-cancer; DRD = 2.38, p = 0.023). DISCUSSION: In both PCa and non-cancer groups, racial/ethnic minorities reported worse experiences compared to NHW individuals for several PCE measures. However, the difference in getting needed care and doctor communication between NHA and NHW individuals were more pronounced in non-cancer group than PCa group.

Building the foundation for a modern patient-partnered infrastructure to study temporomandibular disorders.

Background: Conflicting reports from varying stakeholders related to prognosis and outcomes following placement of temporomandibular joint (TMJ) implants gave rise to the development of the TMJ Patient-Led RoundTable initiative. Following an assessment of the current availability of data, the RoundTable concluded that a strategically Coordinated Registry Network (CRN) is needed to collect and generate accessible data on temporomandibular disorder (TMD) and its care. The aim of this study was therefore to advance the clinical understanding, usage, and adoption of a core minimum dataset for TMD patients as the first foundational step toward building the CRN. Methods: Candidate data elements were extracted from existing data sources and included in a Delphi survey administered to 92 participants. Data elements receiving less than 75% consensus were dropped. A purposive multi-stakeholder sub-group triangulated the items across patient and clinician-based experience to remove redundancies or duplicate items and reduce the response burden for both patients and clinicians. To reliably collect the identified data elements, the identified core minimum data elements were defined in the context of technical implementation within High-performance Integrated Virtual Environment (HIVE) web-application framework. HIVE was integrated with CHIOS™, an innovative permissioned blockchain platform, to strengthen the provenance of data captured in the registry and drive metadata to record all registry transaction and create a robust consent network. Results: A total of 59 multi-stakeholder participants responded to the Delphi survey. The completion of the Delphi surveys followed by the application of the required group consensus threshold resulted in the selection of 397 data elements (254 for patient-generated data elements and 143 for clinician generated data elements). The infrastructure development and integration of HIVE and CHIOS™ was completed showing the maintenance of all data transaction information in blockchain, flexible recording of patient consent, data cataloging, and consent validation through smart contracts. Conclusion: The identified data elements and development of the technological platform establishes a data infrastructure that facilitates the standardization and harmonization of data as well as perform high performance analytics needed to fully leverage the captured patient-generated data, clinical evidence, and other healthcare ecosystem data within the TMJ/TMD-CRN.

A Quantitative Framework to Identify and Prioritize Opportunities in Biomedical Product Innovation: A Proof-of-Concept Study.

Importance: Prioritization and funding for health initiatives, including biomedical innovation, may not consistently target unmet public health needs. Objective: To (1) develop a quantitative, databased framework to identify and prioritize opportunities for biomedical product innovation investments based on a multicriteria decision-making model (MCDM) that includes comprehensive measures of public health burden and health care costs, and (2) pilot test the model. Design, Setting, and Participants: The Department of Health and Human Services (HHS) convened public and private experts to develop a model, select measures, and complete a longitudinal pilot study to identify and prioritize opportunities for investment in biomedical product innovations that have the greatest public health benefit. Cross-sectional and longitudinal data (2012-2019) for 13 pilot medical disorders were obtained from the Institute for Health Metrics Global Burden of Disease database (IHME GBD) and the National Center for Health Statistics (NCHS). Main Outcome Measures: The main outcome measure was an overall gap score reflecting high public health burden (composite measure of mortality, prevalence, years lived with disability, and health disparities), or high health care costs (composite measure of total, public, and out-of-pocket health spending) relative to low biomedical innovation. Sixteen innovation metrics were selected to reflect the pipeline of biomedical products from research and development to market approval. A higher score indicates a greater gap. Normalized composite scores were calculated for public health burden, cost, and innovation investment using the MCDM Technique for Order of Preference by Similarity to Ideal Solution method. Results: Among the 13 conditions tested in the pilot study, diabetes (0.61), osteoarthritis (0.46), and drug-use disorders (0.39) had the highest overall gap score reflecting high public health burden, or high health care costs relative to low biomedical innovation in these medical disorders. Chronic kidney disease (0.05), chronic obstructive pulmonary disease (0.09), and cirrhosis and other liver diseases (0.10) had the least amount of biomedical product innovation despite similar public health burden and health care cost scores. Conclusions: In this cross-sectional pilot study, we developed and implemented a data-driven, proof-of-concept model that can help identify, quantify, and prioritize opportunities for biomedical product innovation. Quantifying the relative alignment between biomedical product innovation, public health burden, and health care cost may help identify and prioritize investments that can have the greatest public health benefit.

Evidence-based objective performance criteria for the evaluation of hip and knee replacement devices and technologies.

BACKGROUND: Objective performance criteria (OPC) is a novel method to provide minimum performance standards and improve the regulated introduction of original or incremental device innovations in order to prevent patients from being exposed to potentially inferior designs whilst allowing timely access to improvements. We developed 2-year safety and effectiveness OPC for total hip and knee replacement (THR and TKR). METHODS: Analyses of large databases were conducted using various data sources: a systematic literature review; a direct data analysis from The Functional Outcomes Research for Comparative Effectiveness in Total Joint Replacement and Quality Improvement Registry (FORCE-TJR) and the Kaiser Permanente Implant Registry (KPIR); and claims data analyses from longitudinal discharge data in New York and California states. The literature review included U.S. patients (≥18 years) who received THR or TKR for primary end-stage osteoarthritis and prospectively collected data on patient-reported outcome measures (PROMs) from at least 100 subjects and/or 2-year implant survival for at least 250 implants. Random effects models were used for meta-analysis. RESULTS: Data were available from a total of 951 100 patients. After screening of 7979 abstracts, 294 studies underwent full-text review and 31 studies contributed to the evidence synthesis (333 995 implants). Direct data analysis of FORCE-TJR contributed 9223 joint replacement patients to the construction of OPC for effectiveness; KPIR contributed 262 044 patients for the construction of OPC for safety. Claims database analysis contributed 345 838 patients to the construction of safety OPC. OPC for safety were constructed for cumulative incidences of 2-year all-cause and septic revision (THR/TKR 2.0%/1.6% and 0.6%/0.7%), and OPC for effectiveness were constructed based on four disease-specific and three general health-related quality of life PROMs (HOOS/KOOS 87.1/80.6; HSS/KSS function 94.4/90.6; SF-12/SF-36, PCS 46.5/41.9, EQ-5D 0.88/0.84). CONCLUSION: This study is the first to construct a 2-year OPC for the safety and effectiveness of THR and TKR based on U.S. real-world data. Based on these OPC, potential benchmarks for (single-arm study) evaluation of new device innovations are suggested for a regulated and safe introduction to the (commercial) market.

Benzonatate Safety and Effectiveness: A Systematic Review of the Literature.

OBJECTIVE: To review the available literature regarding the treatment effects and efficacy of benzonatate needed to better inform patients, providers, and regulators evaluating its role in modern medical therapies. DATA SOURCES: Comprehensive literature searches were conducted in PubMed, Embase (Elsevier), Cochrane Library, and Scopus for original research articles evaluating the effectiveness, tolerability, and safety profile of benzonatate from January 1956 through August 2022. STUDY SELECTION AND DATA EXTRACTION: The identified studies were screened for relevance and then assessed for inclusion through a full-text review, data extraction, and quality assessment by multiple reviewers using the online software Covidence. DATA SYNTHESIS: The selection process resulted in 37 articles consisting of 21 cohort studies, 5 experimental studies, and 11 case studies and series. Initial clinical studies exploring potential therapeutic benefits collected data from very small populations and limited clinical settings. Safety is primarily assessed in terms of toxicity due to overdose or inappropriate use. Quality assessment raised concerns for high degrees of biases primarily related to the limited sample size, data collection, generalizability, and study design. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: This review reveals substantial limitations within existing evidence pertaining to the safety and clinical effectiveness of benzonatate and thus, a need for large observational studies or randomized trials to better characterize its role and value in modern medical practice. CONCLUSIONS: Rising safety concerns should bring closer scrutiny upon the prescription of benzonatate whose approval is founded upon evidence that would not stand up to current regulatory review.

Enhancing Patient Centricity of Real-World Data Research: An Exploratory Analysis Using the Patient Experience Mapping Toolbox.

OBJECTIVES: There is an increasing expectation that medical product development and assessment be guided by patient input captured through patient engagement. Recently published consensus guidelines describe how qualitative patient experience data (PED) can guide the design, conduct, and translation of real-world research that reflects patients' lived experience. The objective of this exploratory analysis is to examine how researchers could leverage PED captured through the Patient Experience Mapping Toolbox (PEMT) to guide real-world data (RWD) research designs. METHODS: This exploratory analysis included a thematic analysis of interview transcripts collected while pilot testing the PEMT followed by a qualitative analysis of the emerging themes aligned with stages listed in the patient-centered real-world evidence, Real-World Research Design Framework. RESULTS: PED collected using the PEMT include information about symptomology, interactions with the healthcare system, information-seeking behavior, misdiagnoses, lifestyle changes, treatments, side effects, and comorbidities. This information can be leveraged at key study design decisions, including (1) identifying study cohorts and subgroups, (2) identifying exposures, (3) informing covariates and potential confounders; and (4) refining study periods. Additionally, participants described where they seek information about treatments and diseases, which should inform dissemination strategies. CONCLUSIONS: We identified opportunities for PED collected using the PEMT to inform RWD study designs. The PED described in this exploratory analysis stem from pilot testing of the PEMT across a variety of conditions. In the next phase of development in this area, researchers should evaluate how data collected using the PEMT can be applied to RWD research for a specific disease.

Data sources and applied methods for paclitaxel safety signal discernment.

Background: Following the identification of a late mortality signal, the Food and Drug Administration (FDA) convened an advisory panel that concluded that additional clinical study data are needed to comprehensively evaluate the late mortality signal observed with the use of drug-coated balloons (DCB) and drug-eluting stent (DES). The objective of this review is to (1) identify and summarize the existing clinical and cohort studies assessing paclitaxel-coated DCBs and DESs, (2) describe and determine the quality of the available data sources for the evaluation of these devices, and (3) present methodologies that can be leveraged for proper signal discernment within available data sources. Methods: Studies and data sources were identified through comprehensive searches. original research studies, clinical trials, comparative studies, multicenter studies, and observational cohort studies written in the English language and published from January 2007 to November 2021, with a follow-up longer than 36 months, were included in the review. Data quality of available data sources identified was assessed in three groupings. Moreover, accepted data-driven methodologies that may help circumvent the limitations of the extracted studies and data sources were extracted and described. Results: There were 39 studies and data sources identified. This included 19 randomized clinical trials, nine single-arm studies, eight registries, three administrative claims, and electronic health records. Methodologies focusing on the use of existing premarket clinical data, the incorporation of all contributed patient time, the use of aggregated data, approaches for individual-level data, machine learning and artificial intelligence approaches, Bayesian approaches, and the combination of various datasets were summarized. Conclusion: Despite the multitude of available studies over the course of eleven years following the first clinical trial, the FDA-convened advisory panel found them insufficient for comprehensively assessing the late-mortality signal. High-quality data sources with the capabilities of employing advanced statistical methodologies are needed to detect potential safety signals in a timely manner and allow regulatory bodies to act quickly when a safety signal is detected.

Racial/Ethnic Disparities in Patient Care Experiences among Prostate Cancer Survivors: A SEER-CAHPS Study.

PURPOSE: To evaluate racial/ethnic disparities in patient care experiences (PCEs) among prostate cancer (PCa) survivors. METHODS: This retrospective study used 2007-2015 National Cancer Institute Surveillance, Epidemiology and End Results registry data linked to Consumer Assessment of Healthcare Providers and Systems surveys. First survey ≥ 6 months post-PCa diagnosis was analyzed. We performed multivariable linear regression, adjusting for demographic and clinical covariates, to evaluate the association of race/ethnicity (non-Hispanic Whites (NHWs), non-Hispanic Black (NHBs), Hispanic, non-Hispanic Asian (NHAs), and other races) with PCE composite measures: getting needed care, doctor communication, getting care quickly, getting needed prescription drugs (Rx), and customer service. RESULTS: Among 7319 PCa survivors, compared to NHWs, Hispanics, NHBs and NHAs reported lower scores for getting care quickly (ß = -3.69; p = 0.002, ß = -2.44; p = 0.021, and ß = -6.44; p < 0.001, respectively); Hispanics scored worse on getting needed care (ß = -2.16; p = 0.042) and getting needed Rx (ß = -2.93; p = 0.009), and NHAs scored worse on customer service (ß = -7.60; p = 0.003), and getting needed Rx (ß = -3.08; p = 0.020). However, NHBs scored better than NHWs on doctor communication (ß = 1.95, p = 0.006). No statistically significant differences were found between other races and NHWs. CONCLUSIONS: Comparing to NHWs, Hispanics and NHAs reported worse experiences on several PCE composite measures, while NHBs reported worse scores on one but better scores on another PCE composite measure. Further research is needed to understand the reasons behind these disparities and their influence on healthcare utilization and health outcomes among PCa survivors.

Naloxone Prescribing Associated With Reduced Emergency Department Visits in the Military Health System.

PURPOSE: The aim was to determine the association between the receipt of naloxone and emergency department (ED) visits within 60 days after the receipt of an opioid. METHODS: A retrospective cohort of individuals 18 years of age or above, enrolled in TRICARE, and were dispensed an opioid at any time from January 1, 2019, through September 30, 2020 was identified within the United States Military Health System. Individuals receiving naloxone within 5 days of the opioid dispensing date were propensity score matched with individuals receiving opioids only. A logistic regression was used to estimate the odds of an ED visit in the 60-day follow-up period after the index opioid dispense event among those co-dispensed naloxone and those receiving opioids only. RESULTS: Of the 2,136,717 individuals who received an opioid prescription during the study period, 800,071 (10.1%) met study inclusion criteria. Overall, 5096 (0.24%) of individuals who received an opioid prescription were co-dispensed naloxone. Following propensity score matching, those who received naloxone had a significantly lower odds of ED utilization in the 60 days after receiving an opioid prescription (odds ratio: 0.74, 95% CI: 0.68-0.80, P<0.001). CONCLUSION: This study highlights the importance of expanding access to naloxone in order to reduce ED utilization. Future research is needed to examine additional outcomes related to naloxone receipt and develop programs that make naloxone prescribing a routine practice.

Development of a core minimum data set to advance real-world evidence generation for uterine fibroids treatment technologies.

Objectives: The accumulation of data through a prospective, multicenter coordinated registry network (CRN) is a robust and cost-effective way to gather real-world evidence on the performance of uterine fibroids treatment technologies for device-based and intervention-based studies. To develop the CRN, a group of uterine fibroids experts, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess uterine fibroid treatment technologies. Design: A Delphi method approach was employed to achieve consensus on a core minimum data set for the CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated, and analyzed by a study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via a conference call. This process was repeated twice over a 3-month time period until consensus was achieved. Results: Twenty-nine experts participated in the Delphi surveys, which began with an initial list of 200 data elements. The working group reached final consensus on 97 data elements capturing patient medical history, imaging data, procedure-related data, post-procedure data, and long-term follow-up data. Conclusions: The CRN successfully convened an expert panel on uterine fibroids treatment technologies and used the Delphi method to produce a consensus-based core set of data elements. These identified data elements include important outcomes related to efficacy and safety and thus, influence patient, provider, and regulatory decision-making about treatments for uterine fibroids. Finally, the core data elements provide the foundation of the infrastructure needed for the CRN that will allow for the comparative study of uterine fibroid treatment devices and technologies.