The Effects of Market Competition on Cardiologists' Adoption of Transcatheter Aortic Valve Replacement.

BACKGROUND: For decades, the prevailing assumption regarding the diffusion of high-cost medical technologies has been that competitive markets favor more aggressive adoption of new treatments by health care providers (ie, the "Medical Arms Race"). However, novel regulations governing the adoption of transcatheter aortic valve replacement (TAVR) may have disrupted this paradigm when TAVR was introduced. OBJECTIVE: The objective of this study was to assess the relationship between the market concentration of physician group practices and the adoption of TAVR in its first years of use. RESEARCH DESIGN: This was a retrospective cohort study. SUBJECTS: Physician group practices (n=5116) providing interventional cardiology services in the United States from May 1, 2012, to December 31, 2014. MEASURES: The first use of TAVR as indicated by a fee-for-service Medicare claim. Covariates including characteristics of the physician groups (ie, case volume, hospital affiliation, mean patient risk) as well as county-level and market-level characteristics. RESULTS: By the close of 2014, 9.3% of practices had adopted TAVR. Cox proportional hazards models revealed a hazard ratio of 1.26 (95% confidence interval: 1.16-1.37, P<0.001) per 1000 point increase in the physician group practice Herfindahl-Hirschman Index, indicating each 1000 point increase in group practice Herfindahl-Hirschman Index was associated with a 26% relative increase in the rate of TAVR adoption. CONCLUSIONS: Adoption of TAVR by physician groups in concentrated markets was potentially a consequence of the unique regulations governing TAVR reimbursement, which favored the adoption of TAVR by physician groups with greater market power. These findings have important implications for how future regulations may shape patterns of technology adoption.

Income Disparities In Access To Critical Care Services.

The coronavirus disease 2019 (COVID-19) pandemic has highlighted the importance of intensive care unit (ICU) beds in preventing death from the severe respiratory illness associated with COVID-19. However, the availability of ICU beds is highly variable across the US, and health care resources are generally more plentiful in wealthier communities. We examined disparities in community ICU beds by US communities' median household income. We found a large gap in access by income: 49 percent of the lowest-income communities had no ICU beds in their communities, whereas only 3 percent of the highest-income communities had no ICU beds. Income disparities in the availability of community ICU beds were more acute in rural areas than in urban areas. Policies that facilitate hospital coordination are urgently needed to address shortages in ICU hospital bed supply to mitigate the effects of the COVID-19 pandemic on mortality rates in low-income communities.

Association Between Spending and Survival of Chronic Heart Failure Across Veterans Affairs Medical Centers.

Importance: The US Department of Veterans Affairs (VA) provides health care to more than 2 000 000 veterans with chronic cardiovascular disease, yet little is known about how expenditures vary across VA Medical Centers (VAMCs), or whether VAMCs with greater health expenditures are associated with better health outcomes. Objectives: To compare expenditures for patients with chronic heart failure (CHF) across the nation's VAMCs and examine the association between health care spending and survival. Design, Setting, and Participants: Retrospective cohort study using existing administrative data sets from the VA's Corporate Data Warehouse and each veteran's Medicare enrollment information and claims history for fee-for-service clinicians outside of the VA from 265 714 patients diagnosed with CHF between April 1, 2010, and December 31, 2013, who received care at any of 138 VAMCs or affiliated outpatient clinics nationwide. Patients were followed up through September 30, 2014. Data were analyzed from April 1, 2010, through September 30, 2014. Main Outcomes and Measures: Main outcomes were patient deaths per calendar quarter and aggregate VA costs per calendar quarter. Hierarchical generalized linear models with hospital-level random effects were estimated to calculate both risk-standardized annual health care expenditures and risk-standardized annual survival rates for veterans with CHF at each VAMC. The association between VAMC-level expenditures and survival was then modeled using local and linear regression. Results: Of the 265 714 patients included, 261 132 (98.7%) were male; 224 353 (84.4%) were white; 41 110 (15.5%) were black, Asian, Pacific Islander, American Indian, or Alaskan Native; and 251 (0.1%) did not report race. Mean (SD) age of the patients included was 74 (10) years. Across 138 VAMCs, mean (95% CI) annual expenditures for veterans with CHF varied from $21 300 ($20 300-$22 400) to $52 800 ($49 400-$54 300) per patient, whereas annual survival varied between 81.4% to 88.9%. There was a modest V-shaped association between spending and survival such that adjusted survival was 1.7 percentage points higher at the minimum level of spending compared with the inflection point of $34 100 per year (P = .001) and 1.9 percentage points higher at the maximum level of spending compared with the inflection point (P = .006). Conclusions and Relevance: Despite marked differences in mean annual expenditures per veteran, only a modest association was found between CHF spending and survival at the VAMC level, with slightly higher survival observed at the extremes of the spending range. Hospitals with high expenditures may be less efficient than their peer institutions in producing optimal health outcomes.

Quality and Value of Health Care in the Veterans Health Administration: A Qualitative Study.

Background The attitudes of Department of Veterans Affairs ( VA ) cardiovascular clinicians toward the VA 's quality-of-care processes, clinical outcomes measures, and healthcare value are not well understood. Methods and Results Semistructured telephone interviews were conducted with cardiovascular healthcare providers (n=31) at VA hospitals that were previously identified as high or low performers in terms of healthcare value. The interviews focused on VA providers' experiences with measures of processes, outcomes, and value (ie, costs relative to outcomes) of cardiovascular care. Most providers were aware of process-of-care measurements, received regular feedback generated from those data, and used that feedback to change their practices. Fewer respondents reported clinical outcomes measures influencing their practice, and virtually no participants used value data to inform their practice, although several described administrative barriers limiting high-cost care. Providers also expressed general enthusiasm for the VA 's quality measurement/improvement efforts, with relatively few criticisms about the workload or opportunity costs inherent in clinical performance data collection. There were no material differences in the responses of employees of low-performing versus high-performing VA medical centers. Conclusions Regardless of their medical center's healthcare value performance, most VA cardiovascular providers used feedback from process-of-care data to inform their practice. However, clinical outcomes data were used more rarely, and value-of-care data were almost never used. The limited use of outcomes data to inform healthcare practice raises concern that healthcare outcomes may have insufficient influence, whereas the lack of value data influencing cardiovascular care practices may perpetuate inefficiencies in resource use.

Outcomes of Care for Ischemic Heart Disease and Chronic Heart Failure in the Veterans Health Administration.

Importance: The Department of Veterans Affairs (VA) operates a nationwide system of hospitals and hospital-affiliated clinics, providing health care to more than 2 million veterans with cardiovascular disease. While data permitting hospital comparisons of the outcomes of acute cardiovascular care (eg, myocardial infarction) are publicly available, little is known about variation across VA medical centers (VAMCs) in outcomes of care for populations of patients with chronic, high-risk cardiovascular conditions. Objective: To determine whether there are substantial differences in cardiovascular outcomes across VAMCs. Design, Setting, and Participants: Retrospective cohort study comprising 138 VA hospitals and each hospital's affiliated outpatient clinics. Patients were identified who received VA inpatient or outpatient care between 2010 and 2014. Separate cohorts were constructed for patients diagnosed as having either ischemic heart disease (IHD) or chronic heart failure (CHF). The data were analyzed between June 24, 2015, and November 21, 2017. Exposures: Hierarchical linear models with VAMC-level random effects were estimated to compare risk-standardized mortality rates for IHD and for CHF across 138 VAMCs. Mortality estimates were risk standardized using a wide array of patient-level covariates derived from both VA and Medicare health care encounters. Main Outcomes and Measures: All-cause mortality. Results: The cohorts comprised 930 079 veterans with IHD and 348 015 veterans with CHF; both cohorts had a mean age of 77 years and were predominantly white (IHD, n = 822 665 [89%] and CHF, n = 287 871 [83%]) and male (IHD, n = 916 684 [99%] and CHF n = 341 352 [98%]). The VA-wide crude annual mortality rate was 7.4% for IHD and 14.5% for CHF. For IHD, VAMCs' risk-standardized mortality varied from 5.5% (95% CI, 5.2%-5.7%) to 9.4% (95% CI, 9.0%-9.9%) (P < .001 for the difference). For CHF, VAMCs' risk-standardized mortality varied from 11.1% (95% CI, 10.3%-12.1%) to 18.9% (95% CI, 18.3%-19.5%) (P < .001 for the difference). Twenty-nine VAMCs had IHD mortality rates that significantly exceeded the national mean, while 35 VAMCs had CHF mortality rates that significantly exceeded the national mean. Veterans Affairs medical centers' mortality rates among their IHD and CHF populations were not associated with 30-day mortality rates for myocardial infarction (R2 = 0.01; P = .35) and weakly associated with hospitalized heart failure 30-day mortality (R2 = 0.16; P < .001) and the VA's star rating system (R2 = 0.06; P = .005). Conclusions and Relevance: Risk-standardized mortality rates for IHD and CHF varied widely across the VA health system, and this variation was not well explained by differences in demographics or comorbidities. This variation may signal substantial differences in the quality of cardiovascular care between VAMCs.

County Jail or Psychiatric Hospital? Ethical Challenges in Correctional Mental Health Care.

Approximately 20% of the roughly 2.5 million individuals incarcerated in the United States have a serious mental illness (SMI). As a result of their illnesses, these individuals are often more likely to commit a crime, end up incarcerated, and languish in correctional settings without appropriate treatment. The objective of the present study was to investigate how correctional facility personnel reconcile the ethical challenges that arise when housing and treating individuals with SMI. Four focus groups and one group interview were conducted with employees ( n = 24) including nurses, clinicians, correctional officers, administrators, and sergeants at a county jail in Pennsylvania. Results show that jail employees felt there are too many inmates with SMI in jail who would benefit from more comprehensive treatment elsewhere; however, given limited resources, employees felt they were doing the best they can. These findings can inform mental health management and policy in a correctional setting.

Sleep Disturbance Partially Mediates the Relationship Between Intimate Partner Violence and Physical/Mental Health in Women and Men.

Intimate partner violence (IPV) is a worldwide health concern and an important risk factor for poor mental/physical health in both women and men. Little is known about whether IPV leads to sleep disturbance. However, sleep problems may be common in the context of IPV and may mediate relationships with mental/physical health. Data from the 2006 Behavioral Risk Factor Surveillance System (BRFSS) were used ( N = 34,975). IPV was assessed in female and male participants for any history of being threatened by, physically hurt by, or forced to have sex with an intimate partner (THREAT, HURT, and SEX, respectively), and, further, as being forced to have sex with or physically injured by an intimate partner within the past year (SEXyr and HURTyr, respectively). These survey items were coded yes/no. Sleep disturbance was assessed as difficulty falling asleep, staying asleep, or sleeping too much at least 6 of the last 14 days. Logistic regression analyses, adjusted for age, sex, race, income, education, and physical/mental health, assessed whether IPV predicted sleep disturbance. Sobel-Goodman tests assessed whether relationships between IPV and physical/mental health were partially mediated by sleep disturbance. All IPV variables were associated with sleep disturbance, even after adjusting for the effects of age, sex, race/ethnicity, income, education, employment, marital status, physical health and mental health. THREAT was associated with sleep disturbance (odds ratio [OR] = 2.798, p < .0001), as was HURT (OR = 2.683, p < .0001), SEX (OR = 3.237, p < .0001), SEXyr (OR = 7.741, p < .0001), and HURTyr (OR = 7.497, p < .0001). In mediation analyses, all IPV variables were associated with mental health ( p < .0001), and all were associated with physical health ( p < .007) except SEXyr. Sleep disturbance partially mediated all relationships (Sobel p < .0005 for all tests). Mediation was around 30%, ranging from 18% (HURTyr and mental health) to 41% (HURT and physical health). IPV was strongly associated with current sleep disturbance above the effect of demographics and overall mental/physical health, even if the IPV happened in the past. Furthermore, sleep disturbance partially mediates the relationship between IPV and mental/physical health. Sleep interventions may potentially mitigate negative effects of IPV.

"Restricted Community Members": Research Protections and Opportunities for Individuals Committed to Assisted Outpatient Treatment.

Several forms of mandated community treatment exist in the United States. One mechanism, assisted outpatient treatment (AOT), has become both more common and more controversial in recent years. The status of individuals committed to AOT remains unclear within regulatory guidelines aimed at protecting research participants. Should individuals on AOT be considered psychiatric inpatients, prisoners, community members, or something else? The authors argue that persons on AOT inhabit a gray area wherein they should be given some of the ethical protections afforded to involuntary inpatients and prisoners, but they should also enjoy freedoms as members of the community. The authors' term for this population is "restricted community members." The need to protect individuals in this population from potentially coercive forces of AOT while also offering them the opportunity to participate in research is especially acute in areas of research where the need is great: serious mental illness and substance use disorders.

Ethical and clinical safety considerations in the design of an effectiveness trial: A comparison of buprenorphine versus naltrexone treatment for opioid dependence.

We examine ethical challenges encountered in the design of an effectiveness trial (CTN-0051; X:BOT), comparing sublingual buprenorphine-naloxone (BUP-NX), an established treatment for opioid dependence, to the newer extended-release injectable naltrexone (XR-NTX). Ethical issues surrounded: 1) known poor effectiveness of one possible, commonly used treatment as usual control condition-detoxification followed by counseling without medication; 2) the role of patients' preferences for treatments, given that treatments were clinically approved and available to the population; 3) differences between the optimal "usual treatment" clinical settings for different treatments making it challenging to design a fair comparison; 4) vested interest groups favoring different treatments exerting potential influence on the design process; 5) potentially vulnerable populations of substance users and prisoners; 6) potential therapeutic misconception in the implementation of safety procedures; and 7) high cost of a large trial limiting questions that could be addressed. We examine how the design features underlying these ethical issues are characteristic of effectiveness trials, which are often large trials that compare treatments with varying degrees of existing effectiveness data and familiarity to patients and clinicians, in community-based treatment settings, with minimal exclusion criteria that could involve vulnerable populations. Hence, investigators designing effectiveness trials may wish to remain alert to the possibility of similar ethical issues.

Diagnosing, Disclosing, and Documenting Borderline Personality Disorder: A Survey of Psychiatrists' Practices.

Borderline personality disorder (BPD) is a valid and reliable diagnosis with effective treatments. However, data suggest many patients remain unaware they carry the diagnosis, even when they are actively engaged in outpatient psychiatric treatment. The authors conducted a survey of 134 psychiatrists practicing in the United States to examine whether they had ever withheld and/or not documented their patients' BPD diagnosis. Fifty-seven percent indicated that at some point during their career they failed to disclose BPD; 37 percent said they had not documented the diagnosis. For those respondents with a history of not disclosing or documenting BPD, most agreed that either stigma or uncertainty of diagnosis played a role in their decisions. The findings highlight the need for clinical training programs to address these issues. The research also invites further research to identify other reasons why psychiatrists are hesitant to be fully open about the diagnosis of BPD.

Proceed with caution: off-label ketamine treatment for major depressive disorder.

Ketamine offers a promising new option for the treatment of depression, but its increasing off-label use is ethically and clinically inappropriate at the moment.

An overview of the pediatric medications for the symptomatic treatment of allergic rhinitis, cough, and cold.

Upper respiratory infections and allergic rhinitis are common diseases in children. In recent years, U.S. Food and Drug Administration has been promoting pediatric drug development with marketing exclusivity incentives and requirements. The assessment of clinical pharmacology, efficacy, and safety data has facilitated pediatric drug development and provided appropriate labeling for pediatric use. Regulatory decision making involves multiple evaluation processes, including drug exposure comparison between adult and pediatric population, formulation bridging, dose selection, and evaluation of efficacy and safety in pediatric patients. This article reviews the pediatric drugs indicated for cough, cold, and allergic rhinitis, focusing on the utility of clinical pharmacology, safety, and efficacy data in determining the pediatric dosing regimen and the approaches taken for regulatory decision making.

Bridges and barriers to successful transitioning as perceived by adolescents and young adults with Asperger syndrome.

In this thematic content analysis we examined the expectations, and perceived facilitators of (referred to as bridges) and barriers to transition to community as reported by adolescents and young adults with Asperger syndrome. Participants were adolescents/young adults, ages 18-23 years were from the East Coast of the United States. Seventy percent of adolescents hoped for employment (n = 10). Thirty percent desired to find a partner and raise a family. Perceived barriers were: self-assessed behavioral problems, self-assessed associated features, other personal factors, and institutional factors. Bridges to facilitate transition were: accommodations in the community, cognitive abilities, personal qualities/strengths, and mentor's qualities.

Continuing education for nurses in the clinical management of autism spectrum disorders: results of a pilot evaluation.

The prevalence of autism spectrum disorders (ASDs) is 1 in 110 in the United States. Nurses encounter patients with ASDs across practice settings. This article describes the results of an evaluation research pilot that assessed the perceived value to nurses of a continuing education program on comprehensive care of people with ASDs. Two 2-day workshops were offered in 2010. Of the 37 participants, 92% were female; 35% worked in pediatrics, 35% worked in adult care, and 30% were administrators; and 33% had practiced for 11 years or more. Six months after the course, 74% shared information with their employers and 94% shared information with coworkers. Although 77% incorporated learning into practice, 23% reported that they had not yet had the opportunity to do so. All participants valued the course content. Future programs can target audiences in specific service areas or those who work with specific populations. This pilot provided useful feedback on the nursing care of people with ASDs that is relevant to a variety of potential audiences. Continuing education programs can target sponsors, donors, client groups, administrators, and staff as they prepare to care for patients with ASDs.