Industry Payment to Vascular Neurologists: A 6-Year Analysis of the Open Payments Program From 2013 Through 2018.

Background and Purpose- Industry payments to physicians raise concerns regarding conflicts of interest that could impact patient care. We explored nonresearch and nonownership payments from industry to vascular neurologists to identify trends in compensation. Methods- Using Centers for Medicare and Medicaid Services and American Board of Psychiatry and Neurology data, we explored financial relationships between industry and US vascular neurologists from 2013 to 2018. We analyzed payment characteristics, including payment categories, payment distribution among physicians, regional trends, and biomedical manufacturers. Furthermore, we analyzed the top 1% (by compensation) of vascular neurologists with detailed payment categories, their position, and their contribution to stroke guidelines. Results- The number of board certified vascular neurologist increased from 1169 in 2013 to 1746 in 2018. The total payments to vascular neurologist increased from $99 749 in 2013 to $1 032 302 in 2018. During the study period, 16% to 17% of vascular neurologists received industry payments. Total payments from industry and mean physician payments increased yearly over this period, with consulting fee (31.1%) and compensation for services other than consulting (30.7%) being the highest paid categories. The top 10 manufacturers made the majority of the payments, and the top 10 products changed from drug or biological products to devices. Physicians from south region of the United States received the highest total payment (38.72%), which steadily increased. Payments to top 1% vascular neurologists increased from 64% to 79% over the period as payments became less evenly distributed. Among the top 1%, 42% specialized in neuro intervention, 11% contributed to American Heart Association/American Stroke Association guidelines, and around 75% were key leaders in the field. Conclusions- A small proportion of US vascular neurologists consistently received the majority of industry payments, the value of which grew over the study period. Only 11% of the top 1% receiving industry payments have authored American Heart Association/American Stroke Association guidelines, but ≈75% seem to be key leaders in the field. Whether this influences clinical practice and behavior requires further investigation.

High priority for hepatitis C screening in safety net hospitals: Results from a prospective cohort of 4582 hospitalized baby boomers.

UNLABELLED: Low-income populations are disproportionately affected by hepatitis C virus (HCV) infection. Thus, implementing baby boomer screening (born 1945-1965) for HCV may be a high priority for safety net hospitals. We report the prevalence and predictors of HCV infection and advanced fibrosis or cirrhosis based on the Fibrosis-4 score plus imaging for a baby boomer cohort admitted to a safety net hospital over a 21-month interval with >9 months of follow-up. Anti-HCV antibody testing was performed for 4582, or 90%, of all never-screened patients, of whom 312 (6.7%) tested positive. Adjusted odds ratios of testing anti-HCV-positive were 2.66 for men versus women (P<0.001), 1.25 for uninsured versus insured (P=0.06), 0.70 for Hispanics versus non-Hispanic whites (P=0.005), and 0.93 per year of age (P<0.001). Among 287 patients tested for HCV RNA (91% of all anti-HCV-positive cases), 175 (61%) were viremic (3.8% overall prevalence in cohort), which was 5% less likely per year of age (P<0.03). Noninvasive staging of 148 (84.6%) chronic HCV patients identified advanced fibrosis or cirrhosis in 50 (33.8%), with higher adjusted odds ratios of 3.21 for Hispanics versus non-Hispanic whites/Asians (P=0.02) and 1.18 per year of age (P=0.001). Other factors associated with significantly higher adjusted odds ratios of advanced fibrosis or cirrhosis were alcohol abuse/dependence, obesity, and being uninsured. CONCLUSION: In this low-income, hospitalized cohort, 4% of 4582 screened baby boomers were diagnosed with chronic HCV, nearly twice the rate in the community; one-third had noninvasive testing that indicated advanced fibrosis or cirrhosis, which was significantly more likely for Hispanics, those of older age, those with obesity, those with alcohol abuse/dependence, and those who lacked insurance.

Relationship quality and patient-assessed quality of care in VA primary care clinics: development and validation of the work relationships scale.

PURPOSE: Efforts to better understand the impact of clinic member relationships on care quality in primary care clinics have been limited by the absence of a validated instrument to assess these relationships. The purpose of this study was to develop and validate a scale assessing relationships within primary care clinics. METHODS: The Work Relationships Scale (WRS) was developed and administered as part of a survey of learning and relationships among 17 Department of Veterans Affairs (VA) primary care clinics. A Rasch partial-credit model and principal components analysis were used to evaluate item performance, select the final items for inclusion, and establish unidimensionality for the WRS. The WRS was then validated against semistructured clinic member interviews and VA Survey of Healthcare Experiences of Patients (SHEP) data. RESULTS: Four hundred fifty-seven clinicians and staff completed the clinic survey, and 247 participated in semistructured interviews. WRS scores were significantly associated with clinic-level reporting for 2 SHEP variables: overall rating of personal doctor/nurse (r(2) =0.43, P <.01) and overall rating of health care (r(2)= 0.25, P <.05). Interview data describing relationship characteristics were consistent with variability in WRS scores across low-scoring and high-scoring clinics. CONCLUSIONS: The WRS shows promising validity as a measure assessing the quality of relationships in primary care settings; moreover, primary care clinics with lower WRS scores received poorer patient quality ratings for both individual clinicians and overall health care. Relationships play an important role in shaping care delivery and should be assessed as part of efforts to improve patient care within primary care settings.

Predictors of No-Show in Neurology Clinics.

In this study, we aim to identify predictors of a no-show in neurology clinics at our institution. We conducted a retrospective review of neurology clinics from July 2013 through September 2018. We compared odds ratio of patients who missed appointments (no-show) to those who were present at appointments (show) in terms of age, lead-time, subspecialty, race, gender, quarter of the year, insurance type, and distance from hospital. There were 60,012 (84%) show and 11,166 (16%) no-show patients. With each day increase in lead time, odds of no-show increased by a factor of 1.0019 (p < 0.0001). Odds of no-show were higher in younger (p ≤ 0.0001, OR = 0.49) compared to older (age ≥ 60) patients and in women (p < 0.001, OR = 1.1352) compared to men. They were higher in Black/African American (p < 0.0001, OR = 1.4712) and lower in Asian (p = 0.03, OR = 0.6871) and American Indian/Alaskan Native (p = 0.055, OR = 0.6318) as compared to White/Caucasian. Patients with Medicare (p < 0.0001, OR = 1.5127) and Medicaid (p < 0.0001, OR = 1.3354) had higher odds of no-show compared to other insurance. Young age, female, Black/African American, long lead time to clinic appointments, Medicaid/Medicare insurance, and certain subspecialties (resident and stroke clinics) are associated with high odds of no show. Possible suggested interventions include better communication and flexible appointments for the high-risk groups as well as utilizing telemedicine.

Hyaluronic acid-bound letrozole nanoparticles restore sensitivity to letrozole-resistant xenograft tumors in mice.

Letrozole is a potent aromatase inhibitor and superior to other defined selective estrogen receptor modulators such as tamoxifen in treating hormone-responsive postmenopausal breast cancer patients. Patients who receive this drug may become insensitive to the effects of estrogen deprivation induced by letrozole. Letrozole has known side effects on bone metabolism due to systemic ablation of estrogen production. The purpose of this study was to examine the therapeutic efficacy of hyaluronic acid-bound letrozole nanoparticles (HA-Letr-NPs) in restoring sensitivity to letrozole-resistant (LTLT-Ca) cells. To target letrozole to LTLT-Ca cells, hyaluronic acid-bound letrozole nanoparticles were prepared by nanoprecipitation using biodegradable PLGA-PEG co-polymer. Binding specificity of HA to CD44 on the cell surface was analyzed in vitro using FITC-CD44 Ab and CD44 siRNA by flow cytometry. Effects on in vitro cytotoxicity and aromatase enzymatic activity of HA-Letr-NPs were performed in MCF-7 breast cancer cells, MCF-7 cells over-expressing aromatase (MCF-7/Aro), and LTLT-Ca cells resistant to letrozole. Preclinical efficacy of HA-Letr-NPs was examined in mice using LTLT-Ca xenograft tumors. HA-Letr-NPs were restricted to a maximum size of 100 nm. The in vitro drug release assay showed that the highest released concentration of letrozole occurred after 23 hours at 37 degrees C in phosphate-buffered saline. HA-Letr-NPs on MCF-7/Aro and LTLT-Ca cells showed an IC50 of 2 microM and 5 microM, respectively. HA-Letr-NPs were more efficacious in inhibiting tumor growth, reducing in vitro cellular and in vivo tumor aromatase enzyme activity more than the corresponding Letr-NPs or letrozole. HA-Letr-NPs restored and maintained a prolonged sensitivity and targeted delivery of letrozole in letrozole-resistant tumors in vivo.

Cost-Effectiveness of Emergent MRI during Stroke Alert to Diagnose Stroke Mimics: Single-Center Experience.

Objective The aim of this article was to assess the role of emergent magnetic resonance imaging (MRI) for stroke mimics during a stoke alert (within 45 minutes) in reducing direct cost of management and duration of inpatient stay. Methods We did a retrospective chart review of all the patients who received emergent MRI brain during a stroke alert to help make decision about intravenous tissue-type plasminogen activator (IV tPA) administration from January 2013 to December 2015. Using the patient financial resource data and with the help of billing department, we calculated the approximate money saved in taking care of the patients who may have received IV tPA if emergent MRI brain was not available to diagnose stroke mimics as they presented with acute neurologic deficit within IV tPA time window. Results Ninety seven out of 1,104 stroke alert patients received emergent MRI. Of these only 17 (17.5%) were diagnosed with acute ischemic stroke (AIS), and 80 (82.5%) as stroke mimics. By doing emergent MRI for suspected stroke mimics, our study showed an approximate total saving of $1,005,720 to $1,384,560, that is, $12,571 to $17,307 per patient in medical expenditure. Discussion We suggest modification of stroke pathway from current algorithm "CT+CTA≥IV-tPA/neurointervention≥MRI" to "MRI+MRA≥IV-tPA/neurointervention" for possible stroke mimics, which can reduce the cost, radiation exposure, and duration of hospital stay for stroke mimics. Conclusion Emergent MRI is a cost-effective tool to evaluate IV-tPA eligibility for suspected stroke mimics during a stroke alert.

Stroke transfers for thrombectomy in the era of extended time.

BACKGROUND AND PURPOSE: The Dawn and Extend Intra-Arterial (IA) acute stroke intervention trials have proven the benefit of thrombectomy in a select group of patients up to 24 h since their last known well time (LKWT) or time of symptom onset. Following the issuance of new treatment guidelines for large vessel occlusion strokes, we reviewed the paradigm shift effect on transfers for possible thrombectomy in a rural state. HYPOTHESIS: Extended time window for thrombectomy increases the need for better identification of potential transfers for thrombectomy in rural states with few hospitals capable of 24/7 interventional thrombectomy. METHODS: We analyzed all transfers to a comprehensive stroke center (CSC) from January to December 2018 which were specifically transferred for possible further intervention. This time period was selected in accordance with the change in American Heart Association (AHA) guidelines for extended time windows in mechanical thrombectomy (MT) care. RESULTS: A total of 132 patients were transferred for possible thrombectomy and advanced imaging. Thirty-four % patients underwent diagnostic angiogram with 33% patients having successful MT. Of the excluded patients 19% had large core infarcts by the time they arrived at hub hospital, 1.5% had hemorrhagic conversion, 32% had stroke without treatable occlusion not amenable for thrombectomy or cortical strokes on follow-up imaging, and 13.5% did not have stroke or LVO on follow-up imaging. CONCLUSION: Since the AHA's change in time window guidelines for mechanical thrombectomies, there has been an increased effort in identifying good candidates with computerized tomography angiography (CTA). To avoid undue burden on stroke systems of care, CTA identification of these patients at the spoke hospitals is key along with timely transport to appropriate thrombectomy capable sites. Given the rural nature of this state along with limited resources, selection of patients is a practical issue, especially for avoiding futile transfers, which might be true for large areas of the USA.

Intractable Scapular Pain Due to Undiagnosed Osteoid Osteoma: A Case Report.

A 36-year-old female patient presented to our stroke neurology clinic for progressively worsening intractable, sharp, shooting interscapular pain radiating to the right shoulder and neck, which she had experienced for 4 years. She had previously seen an orthopedist and was referred to a neurosurgeon for surgical intervention after an MRI of the cervical spine showed the C3-C4 right vertebral artery loop protruding into the right C3-C4 neural foramen and compressing the exiting C4 nerve root. MR neurography showed a stable tortuous right vertebral artery loop, causing a mass effect on the dorsal root ganglion. A neuroforaminal decompression surgery was planned. However, the patient visited our stroke neurology clinic for a second opinion before surgery. An MRI of the thoracic spine showed an enhancing soft tissue mass at the right T4-T5 pedicles and adjacent body. A chest CT with contrast showed a 1 cm radiolucent lesion in the superior articular facet of T5, which represented a nidus. A technetium bone scan showed focal increased uptake within the right T5 pedicle, which is indicative of osteoid osteoma. The patient underwent laminectomy/resection and was pain-free at a 6-month follow-up; biopsy confirmed osteoid osteoma. This case illustrates the importance of neurolocalization during diagnostic testing.

When Telestroke Programs Work, Hospital Size Really Does Not Matter.

Background There are still marked disparities in stroke care between rural and urban communities including difference in stroke-related mortality. We analyzed the efficiency of tissue plasminogen activator (tPA) delivery in the spoke sites in our telestroke network to assess impact of telecare in bridging these disparities. Methods We analyzed critical time targets in our telestroke network. These included door-to-needle (DTN) time, door-to-CT (D2CT) time, door-to-call center, door-to-neurocall, and total consult time. We compared these time targets between the larger and smaller spoke hospitals. Results Across all the 52 spokes sites, a total of 825 stroke consults received intravenous tPA. When compared with larger hospitals (>200 beds), the smaller hospital groups with 0 to 25 and 51 to 100 beds had significantly lower D2CT time ( p -value 0.01 and 0.005, respectively) and the ones with 26 to 50 and 151 to 200 beds had significantly lower consult time ( p -value 0.009 and 0.001, respectively). There was no significant difference in the overall DTN time when all the smaller hospital groups were compared with larger hospitals. Conclusion In our telestroke network, DTN times were not significantly affected by the hospital bed size. This shows that a protocol-driven telestroke network with frequent mock codes can ensure timely administration of tPA even in rural communities regardless of the hospital size and availability of local neurologists.

Trends of Industry Payments in Neurology Subspecialties.

Background Open Payments is a national disclosure program to promote transparency by the public disclosure of financial relationships between the pharmaceutical and medical device industries and physicians. Objective To explore payments from the industry to physicians in various neurology subspecialties. Methods Open Payments Program (OPP) data (https://openpaymentsdata.cms.gov) on industry-to-physician payments for the years 2014-2018 were extracted for general neurology, neuromuscular, neurophysiology, and vascular neurology. The data were then analyzed to explore trends in payments for various subspecialties and to identify the possible factors underlying these trends. Results Overall, industry-to-physician payments for neurology subspecialties increased by 16% from 2014 to 2018. The introduction of newer drugs in a subspecialty was likely the driving factor for higher industry payments. Nearly half of the total industry-to-physician payments were for the subspecialty of multiple sclerosis (MS)/Neuroimmunology; this coincided with Aubagio and Copaxone being the top two medications associated with the highest industry payments in 2014, Aubagio, and Lemtrada in 2018. A significant increase in spending percentages for headache, neuromuscular disorders, and movement disorders was observed while a relative decrease in the payments for MS/neuroimmunology and epilepsy was identified; these trends coincide with the introduction of new drugs such as Aimovig, Neuplazid, Nusinersen, and Austedo for headache, neuromuscular and movement disorders. Conclusions From 2014 to 2018, the total industry-to-physician payments for neurology subspecialties increased while the distribution of industry-to-physician payments for various neurology subspecialties showed notable changes. The introduction of newer medications in a subspecialty coincided with higher industry payments. Identification of these trends and potential motives of the industry spending is critical to address any potential physician bias in prescribing medications.

Why are acute ischemic stroke patients not receiving thrombolysis in a telestroke network?

OBJECTIVE: The purpose of this study was to determine reasons for not giving intravenous tissue plasminogen activator to eligible patients with acute ischemic stroke in a telestroke network. METHODS: We performed a retrospective analysis of prospectively collected data of patients who were seen as a telestroke consultation during 2015 and 2016 with the Arkansas Stroke Assistance through Virtual Emergency Support programme for possible acute ischemic stroke. RESULTS: Total consultations seen were 809 in 2015 and 744 in 2016, out of which 238 patients in 2015 and 247 patients in 2016 received intravenous tissue plasminogen activator. In 2015 and 2016, out of the remaining 571 and 497 patients, 294 and 200 patients respectively were thought to be cases of acute stroke based on clinical evaluation. The most common reasons for not being treated in 2015 and 2016, respectively, were; (a) minimal deficits in 42.17% and 49.5% cases, (b) falling out of the 4.5-hour time window in 22.44% and 22% cases, (c) patient/next of kin refusal in 18.02% and 16.5% cases. Less common reasons included limited functional status, abnormal labs (thrombocytopenia, elevated international normalised ratio (INR)/prothrombin time (PT)/partial thromboplastin time (PTT), hypo or hyperglycemia etc), recent surgery and symptoms being too severe etc. CONCLUSION: 'Minimal deficits' and 'out of time window' continue to be the major causes for not receiving thrombolysis during acute ischemic stroke in both traditional and telestroke systems. Patient/next of kin refusal was high in our telestroke system when compared to traditional practices. Considering the increasing utility of telestroke this needs to be further looked into, along with the ways to address it.

Elevated aromatase expression correlates with cervical carcinoma progression.

OBJECTIVES: We have previously demonstrated that aromatase mRNA is induced in cervical carcinomas compared to normal tissue, suggesting that in situ aromatase expression leading to elevated local estrogen production may contribute to cervical carcinogensis. Our objectives are to examine 1) whether aromatase protein and activity are induced in cervical carcinomas, 2) aromatase expression correlates with disease stage, and 3) inflammatory cytokines (e.g., IL-6 and TNFalpha) may correlate with aromatase expression. METHODS: RNA and protein were isolated from human cervical carcinomas and normal cervical biopsies to examine aromatase expression, using real-time RT-PCR, Western blot analysis, and immunohistochemistry. Aromatase activity in tissue was measured using the tritiated water release method. IL-6 and TNFalpha expression was also examined. RESULTS: Aromatase protein and activity levels were increased in cervical carcinomas compared to normal tissue. RNA levels correlated significantly with disease progression, with highest aromatase expression detected in stage IV tumors (p<0.001, R(2)=0.77). Aromatase promoters 1.3 and 1.4 were elevated in cervical carcinomas and in cervical cancer cells. The expression of inflammatory cytokines IL-6 and TNFalpha, known to induce aromatase, significantly correlated with aromatase expression (R(2)>0.9). TNFalpha treatment induced aromatase expression in cervical cancer cells. CONCLUSION: Increased aromatase protein and activity in cervical carcinomas and the correlation of its expression with disease stage implicates it in cervical carcinogenesis. The correlation of IL-6 and TNFalpha expression with aromatase suggests that these inflammatory cytokines may induce aromatase expression, which is confirmed by induction of aromatase expression due to TNFalpha treatment of cervical cancer cells.

Hospital-Based Hepatitis C Screening of Baby Boomers in a Majority Hispanic South Texas Cohort: Successes and Barriers to Implementation.

OBJECTIVE: To comply with the 2012 CDC recommendations for hepatitis C virus (HCV) screening, we implemented a new HCV screening program for patients born between 1945 and 1965 at a South Texas safety-net hospital. METHODS: Patients with no HCV diagnosis or prior HCV test received an automated order for HCV antibody (anti-HCV) tests combined with reflex HCV ribonucleic acid (RNA) polymerase chain reaction. An inpatient counselor educated anti-HCV-positive patients. A bilingual patient navigator assisted newly diagnosed chronic HCV patients with linkage to primary and specialty care. We examined results for Hispanic vs. non-Hispanic patients in the first 10 months of project implementation in 2013-2014. RESULTS: Of 2,327 patients screened for HCV, the 192 (8%) patients who tested anti-HCV positive were younger than those who tested negative (56 vs. 58 years, respectively, p<0.001) and more likely to be male (p<0.001). Of the 167 anti-HCV-positive patients tested for HCV RNA, 108 (65%) were HCV RNA positive (5% of cohort). Barriers to care for HCV RNA-positive patients included a lack of health insurance, current substance abuse, incarceration, and homelessness. Hispanic HCV RNA-positive patients were more likely than non-Hispanic HCV RNA-positive patients to be substance abusers or incarcerated. Of all HCV RNA-positive patients, 103 patients (95%) received counseling, 94 patients (87%) were linked to primary care, 47 patients (44%) were linked to specialty care, and eight patients (7%) started treatment. CONCLUSION: The prevalence of anti-HCV-positive and chronically HCV-infected patients was higher than many Hispanic or non-Hispanic white cohorts. Most Hispanic patients newly diagnosed with chronic HCV had barriers to care for HCV infection that must be overcome if HCV screening is to reduce morbidity and mortality in this population.

Implementing hospital-based baby boomer hepatitis C virus screening and linkage to care: Strategies, results, and costs.

BACKGROUND/OBJECTIVE: The US Preventive Services Task Force recommends 1-time hepatitis C virus (HCV) screening of all baby boomers (born 1945-1965). However, little is known about optimal ways to implement HCV screening, counseling, and linkage to care. We developed strategies following approaches used for HIV to implement baby boomer HCV screening in a hospital setting and report results as well as costs. DESIGN/PATIENTS: Prospective cohort of 6140 baby boomers admitted to a safety-net hospital in South Texas from December 1, 2012 to January 31, 2014 and followed to December 10, 2014. PROCEDURES/MEASUREMENTS: The HCV screening program included clinician/staff education, electronic medical record algorithm for eligibility and order entry, opt-out consent, anti-HCV antibody test with reflex HCV RNA, personalized inpatient counseling, and outpatient case management. Outcomes were anti-HCV antibody-positive and HCV RNA-positive results. RESULTS: Of 3168 eligible patients, 240 (7.6%) were anti-HCV positive, which was more likely (P < 0.05) for younger age, men, and uninsured. Of 214 (89.2%) patients tested for HCV RNA, 134 (4.2% of all screened) were positive (chronic HCV). Among patients with chronic HCV, 129 (96.3%) were counseled, 108 (80.6%) received follow-up primary care, and 52 (38.8%) received hepatology care. Five patients initiated anti-HCV therapy. Total costs for start-up and implementation for 14 months were $286,482. CONCLUSIONS: This inpatient HCV screening program diagnosed chronic HCV infection in 4.2% of tested patients and linked >80% to follow-up care. Yet access to therapy is challenging for largely uninsured populations, and most programmatic costs of the program are not currently covered.