Bundled Payments for Care Improvement and Quality of Care and Outcomes in Heart Failure.

Importance: The Centers for Medicare & Medicaid Services (CMS) Bundled Payments for Care Improvement (BPCI) program was launched in 2013 with a goal to improve care quality while lowering costs to Medicare. Objective: To compare changes in the quality and outcomes of care for patients hospitalized with heart failure according to hospital participation in the BPCI program. Design, Setting, and Participants: This cross-sectional study used a difference-in-difference approach to evaluate the BPCI program in 18 BPCI hospitals vs 211 same-state non-BPCI hospitals for various process-of-care measures and outcomes using American Heart Association Get With The Guidelines-Heart Failure registry and CMS Medicare claims data from November 1, 2008, to August 31, 2018. Data were analyzed from May 2022 to May 2023. Exposures: Hospital participation in CMS BPCI Model 2 Heart Failure, which paid hospitals in a fee-for-service process and then shared savings or required reimbursement depending on how the total cost of an episode of care compared with a target price. Main Outcomes and Measures: Primary end points included 7 quality-of-care measures. Secondary end points included 9 outcome measures, including in-hospital mortality and hospital-level risk-adjusted 30-day and 90-day all-cause readmission rate and mortality rate. Results: During the study period, 8721 patients were hospitalized in the 23 BPCI hospitals and 94 530 patients were hospitalized in the 224 same-state non-BPCI hospitals. Less than a third of patients (30 723 patients, 29.8%) were 75 years or younger; 54 629 (52.9%) were female, and 48 622 (47.1%) were male. Hospital participation in BPCI Model 2 was not associated with significant differential changes in the odds of various process-of-care measures, except for a decreased odds of evidence-based ß-blocker at discharge (adjusted odds ratio [aOR], 0.63; 95% CI, 0.41-0.98; P = .04). Participation in the BPCI was not associated with a significant differential change in the odds of receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or angiotensin receptor-neprilysin inhibitors at discharge, receiving an aldosterone antagonist at discharge, having a cardiac resynchronization therapy (CRT)-defibrillator or CRT pacemaker placed or prescribed at discharge, having implantable cardioverter-defibrillator (ICD) counseling or an ICD placed or prescribed at discharge, heart failure education being provided among eligible patients, or having a follow-up visit within 7 days or less. Participation in the BPCI was associated with a significant decrease in odds of in-hospital mortality (aOR, 0.67; 95% CI, 0.51-0.86; P = .002). Participation was not associated with a significant differential change in hospital-level risk-adjusted 30-day or 90-day all-cause readmission rate and 30-day or 90-day all-cause mortality rate. Conclusion and Relevance: In this study, hospital participation in the BPCI Model 2 Heart Failure program was not associated with improvement in process-of-care quality measures or 30-day or 90-day risk-adjusted all-cause mortality and readmission rates.

Healthcare Market-Level and Hospital-Level Disparities in Access to and Utilization of High-Quality Hip and Knee Replacement Hospitals Among Medicare Beneficiaries.

INTRODUCTION: This study aimed to determine whether healthcare markets with higher social vulnerability have lower access to high-quality hip and knee replacement hospitals and whether hospitals that serve a higher percentage of low-income patients are less likely to be designated as high-quality. METHODS: This cross-sectional study used 2021 Centers for Medicare and Medicaid Services outcome measures and 2022 Joint Commission (JC) process-of-care measures to identify hospitals performing high-quality hip and knee replacement. A total of 2,682 hospitals and 304 healthcare markets were included. For the market-level analysis, we assessed the association of social vulnerability with the presence of a high-quality hip and knee replacement center. For the hospital-level analysis, we assessed the association of disproportionate share hospital (DSH) percentage with each high-quality designation. Healthcare markets were approximated by hospital referral regions. All associations were assessed with fractional regressions using generalized linear models with binomial family and logit links. RESULTS: We found that healthcare markets in the most vulnerable quartile were less likely to have a hip and knee replacement hospital that did better than the national average (odds ratio [OR] 0.22, P = 0.02) but not more or less likely to have a hospital certified as advanced by JC (OR 0.41, P = 0.16). We found that hip and knee replacement hospitals in the highest DSH quartile were less likely to be designated by the Centers for Medicare and Medicaid Services as better than the national average (OR 0.18, P = 0.001) but not more or less likely to be certified as advanced by JC (OR 1.40, P = 0.28). DISCUSSION: Geographic distribution of high-quality hospitals may contribute to socioeconomic disparities in patients' access to and utilization of high-quality hip and knee replacement. Equal access to and utilization of hospitals with high-quality surgical processes does not necessarily indicate equitable access to and utilization of hospitals with high-quality outcomes. LEVEL OF EVIDENCE: Level III.

Lifetime healthcare expenses across demographic and cardiovascular risk groups: The application of a novel modeling strategy in a large multiethnic cohort study.

Objective: To understand the burden of healthcare expenses over the lifetime of individuals and evaluate differences among those with cardiovascular risk factors and among disadvantaged groups based on race/ethnicity and sex. Methods: We linked data from the longitudinal multiethnic Dallas Heart Study, which recruited participants between 2000 and 2002, with inpatient and outpatient claims from all hospitals in the Dallas-Fort Worth metroplex through December 2018, capturing encounter expenses. Race/ethnicity and sex, as well as five risk factors, hypertension, diabetes, hyperlipidemia, smoking, and overweight/obesity, were defined at cohort enrollment. For each individual, expenses were indexed to age and cumulated between 40 and 80 years of age. Lifetime expenses across exposures were evaluated as interactions in generalized additive models. Results: A total of 2184 individuals (mean age, 45±10 years; 61% women, 53% Black) were followed between 2000 and 2018. The mean modeled lifetime cumulative healthcare expenses were $442,629 (IQR, $423,850 to $461,408). In models that included 5 risk factors, Black individuals had $21,306 higher lifetime healthcare spending compared with non-Black individuals (P < .001), and men had modestly higher expenses than women ($5987, P < .001). Across demographic groups, the presence of risk factors was associated with progressively higher lifetime expenses, with significant independent association of diabetes ($28,075, P < .001), overweight/obesity ($8816, P < .001), smoking ($3980, P = .009), and hypertension ($528, P = .02) with excess spending. Conclusion: Our study suggests Black individuals have higher lifetime healthcare expenses, exaggerated by the substantially higher prevalence of risk factors, with differences emerging in older age.

Association of Marital/Partner Status with Hospital Readmission Among Young Adults With Acute Myocardial Infarction.

Introduction: Despite evidence supporting the benefits of marriage on cardiovascular health, the impact of marital/partner status on the long-term readmission of young acute myocardial infarction (AMI) survivors is less clear. We aimed to examine the association between marital/partner status and 1-year all-cause readmission, and explore sex differences, among young AMI survivors. Methods: Data were from the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients), which enrolled young adults aged 18-55 years with AMI (2008-2012). The primary end point was all-cause readmission within 1 year of hospital discharge, obtained from medical record, patient interviews, and adjudicated by a physician panel. We performed Cox proportional hazards models with sequential adjustment for demographic, socioeconomic, clinical and psychosocial factors. Sex-marital/partner status interaction was also tested. Results: Of the 2,979 adults with AMI (2002 women [67.2%]; mean age 48 [interquartile range, 44-52] years), unpartnered individuals were more likely to experience all-cause readmissions compared with married/partnered individuals within the first year after hospital discharge (34.6% versus 27.2%, hazard ratio [HR]=1.31; 95% confidence interval [CI], 1.15-1.49). The association attenuated but remained significant after adjustment for demographic and socioeconomic factors (adjusted HR, 1.16; 95%CI, 1.01-1.34), and was not significant after further adjusting for clinical factors and psychosocial factors (adjusted HR, 1.10; 95%CI, 0.94-1.28). Sex-marital/partner status interaction was not significant (p=0.69). Sensitivity analysis using data with multiple imputation, and restricting outcomes to cardiac readmission yielded comparable results. Conclusions: In a cohort of young adults aged 18-55 years, unpartnered status was associated with 1.3-fold increased risk of all-cause readmission within 1 year of AMI discharge. Further adjustment for demographic, socioeconomic, clinical and psychosocial factors attenuated the association, suggesting that these factors may explain disparities in readmission between married/partnered versus unpartnered young adults. Whereas young women experienced more readmission compared to similar-aged men, the association between marital/partner status and 1-year readmission did not vary by sex.

Variation in Risk-Standardized Acute Admission Rates Among Patients With Heart Failure in Accountable Care Organizations: Implications for Quality Measurement.

Background Accountable care organizations (ACOs) aim to improve health care quality and reduce costs, including among patients with heart failure (HF). However, variation across ACOs in admission rates for patients with HF and associated factors are not well described. Methods and Results We identified Medicare fee-for-service beneficiaries with HF who were assigned to a Medicare Shared Savings Program ACO in 2017 and survived ≥30 days into 2018. We calculated risk-standardized acute admission rates across ACOs, assigned ACOs to 1 of 3 performance categories, and examined associations between ACO characteristics and performance categories. Among 1 232 222 beneficiaries with HF, 283 795 (mean age, 81 years; 54% women; 86% White; 78% urban) were assigned to 1 of 467 Medicare Shared Savings Program ACOs. Across ACOs, the median risk-standardized acute admission rate was 87 admissions per 100 people, ranging from 61 (minimum) to 109 (maximum) admissions per 100 beneficiaries. Compared to the overall average, 13% of ACOs performed better on risk-standardized acute admission rates, 72% were no different, and 14% performed worse. Most ACOs with better performance had fewer Black beneficiaries and were not hospital affiliated. Most ACOs that performed worse than average were large, located in the Northeast, had a hospital affiliation, and had a lower proportion of primary care providers. Conclusions Admissions are common among beneficiaries with HF in ACOs, and there is variation in risk-standardized acute admission rates across ACOs. ACO performance was associated with certain ACO characteristics. Future studies should attempt to elucidate the relationship between ACO structure and characteristics and admission risk.

Adjustment for Social Risk Factors in a Measure of Clinician Quality Assessing Acute Admissions for Patients With Multiple Chronic Conditions.

Importance: Adjusting quality measures used in pay-for-performance programs for social risk factors remains controversial. Objective: To illustrate a structured, transparent approach to decision-making about adjustment for social risk factors for a measure of clinician quality that assesses acute admissions for patients with multiple chronic conditions (MCCs). Design, Setting, and Participants: This retrospective cohort study used 2017 and 2018 Medicare administrative claims and enrollment data, 2013 to 2017 American Community Survey data, and 2018 and 2019 Area Health Resource Files. Patients were Medicare fee-for-service beneficiaries 65 years or older with at least 2 of 9 chronic conditions (acute myocardial infarction, Alzheimer disease/dementia, atrial fibrillation, chronic kidney disease, chronic obstructive pulmonary disease or asthma, depression, diabetes, heart failure, and stroke/transient ischemic attack). Patients were attributed to clinicians in the Merit-Based Incentive Payment System (MIPS; primary health care professionals or specialists) using a visit-based attribution algorithm. Analyses were conducted between September 30, 2017, and August 30, 2020. Exposures: Social risk factors included low Agency for Healthcare Research and Quality Socioeconomic Status Index, low physician-specialist density, and Medicare-Medicaid dual eligibility. Main Outcomes and Measures: Number of acute unplanned hospital admissions per 100 person-years at risk for admission. Measure scores were calculated for MIPS clinicians with at least 18 patients with MCCs assigned to them. Results: There were 4 659 922 patients with MCCs (mean [SD] age, 79.0 [8.0] years; 42.5% male) assigned to 58 435 MIPS clinicians. The median (IQR) risk-standardized measure score was 38.9 (34.9-43.6) per 100 person-years. Social risk factors of low Agency for Healthcare Research and Quality Socioeconomic Status Index, low physician-specialist density, and Medicare-Medicaid dual eligibility were significantly associated with the risk of hospitalization in the univariate models (relative risk [RR], 1.14 [95% CI, 1.13-1.14], RR, 1.05 [95% CI, 1.04-1.06], and RR, 1.44 [95% CI, 1.43-1.45], respectively), but the association was attenuated in adjusted models (RR, 1.11 [95% CI 1.11-1.12] for dual eligibility). Across MIPS clinicians caring for variable proportions of dual-eligible patients with MCCs (quartile 1, 0%-3.1%; quartile 2, >3.1%-9.5%; quartile 3, >9.5%-24.5%, and quartile 4, >24.5%-100%), median measure scores per quartile were 37.4, 38.6, 40.0, and 39.8 per 100 person-years, respectively. Balancing conceptual considerations, empirical findings, programmatic structure, and stakeholder input, the Centers for Medicare & Medicaid Services decided to adjust the final model for the 2 area-level social risk factors but not dual Medicare-Medicaid eligibility. Conclusions and Relevance: This cohort study demonstrated that adjustment for social risk factors in outcome measures requires weighing high-stake, competing concerns. A structured approach that includes evaluation of conceptual and contextual factors, as well as empirical findings, with active engagement of stakeholders can be used to make decisions about social risk factor adjustment.

Hemodynamic differences between women and men with elevated blood pressure in China: A non-invasive assessment of 45,082 adults using impedance cardiography.

BACKGROUND: Whether there are sex differences in hemodynamic profiles among people with elevated blood pressure is not well understood and could guide personalization of treatment. METHODS AND RESULTS: We described the clinical and hemodynamic characteristics of adults with elevated blood pressure in China using impedance cardiography. We included 45,082 individuals with elevated blood pressure (defined as systolic blood pressure of ≥130 mmHg or a diastolic blood pressure of ≥80 mmHg), of which 35.2% were women. Overall, women had a higher mean systolic blood pressure than men (139.0 [±15.7] mmHg vs 136.8 [±13.8] mmHg, P<0.001), but a lower mean diastolic blood pressure (82.6 [±9.0] mmHg vs 85.6 [±8.9] mmHg, P<0.001). After adjusting for age, region, and body mass index, women <50 years old had lower systemic vascular resistance index (beta-coefficient [ß] -31.7; 95% CI: -51.2, -12.2) and higher cardiac index (ß 0.07; 95% CI: 0.04, 0.09) than men of their same age group, whereas among those ≥50 years old women had higher systemic vascular resistance index (ß 120.4; 95% CI: 102.4, 138.5) but lower cardiac index (ß -0.15; 95% CI: -0.16, -0.13). Results were consistent with a propensity score matching sensitivity analysis, although the magnitude of the SVRI difference was lower and non-significant. However, there was substantial overlap between women and men in the distribution plots of these variables, with overlapping areas ranging from 78% to 88%. CONCLUSIONS: Our findings indicate that there are sex differences in hypertension phenotype, but that sex alone is insufficient to infer an individual's profile.

Shared Decision-making in the U.S.: Evidence exists, but implementation science must now inform policy for real change to occur.

Shared decision making (SDM) is defined as an approach in which clinicians and patients share the best available evidence when faced with the task of making decisions, and in which patients are supported to consider options to achieve informed preferences [1]. Over the past decade, SDM has been increasingly recognized as a component of value-based care in the US. There is greater acceptance overall that SDM is a key strategy for achieving patient-centered care, enhancing patient safety, and achieving the triple aim of better health, better care, and lower costs [2]. Essential elements of SDM include recognizing and acknowledging that a decision is required; knowing and understanding the best available evidence on risks and benefits; and incorporating the patient's values and preferences into the decision [3]. This paper provides an update of our previous review of SDM in the US published in 2017. We describe changes in healthcare policies to support SDM at the federal and state levels, the integration of SDM into clinical practice, and the role of implementation science to advance SDM. Finally, we discuss potential next steps to inform policies for SDM and facilitate uptake of SDM in clinical practice.

National Trends in Racial and Ethnic Disparities in Antihypertensive Medication Use and Blood Pressure Control Among Adults With Hypertension, 2011-2018.

Poor hypertension awareness and underuse of guideline-recommended medications are critical factors contributing to poor hypertension control. Using data from 8095 hypertensive people aged ≥18 years from the National Health and Nutrition Examination Survey (2011-2018), we examined recent trends in racial and ethnic differences in awareness and antihypertensive medication use, and their association with racial and ethnic differences in hypertension control. Between 2011 and 2018, age-adjusted hypertension awareness declined for Black, Hispanic, and White individuals, but the 3 outcomes increased or did not change for Asian individuals. Compared with White individuals, Black individuals had a similar awareness (odds ratio, 1.20 [0.96-1.45]) and overall treatment rates (1.04 [0.84-1.25]), and received more intensive antihypertensive medication if treated (1.41 [1.27-1.56]), but had a lower control rate (0.72 [0.61-0.83]). Asian and Hispanic individuals had significantly lower awareness rates (0.69 [0.52-0.85] and 0.74 [0.59-0.89]), overall treatment rates (0.72 [0.57-0.88] and 0.69 [0.55-0.82]), received less intensive medication if treated (0.60 [0.50-0.72] and 0.86 [0.75-0.96]), and had lower control rates (0.66 [0.54-0.79] and 0.69 [0.57-0.81]). The racial and ethnic differences in awareness, treatment, and control persisted over the study period and were consistent across age, sex, and income strata. Lower awareness and treatment were significantly associated with lower control in Asian and Hispanic individuals (P<0.01 for all) but not in Black individuals. These findings highlight the need for interventions to improve awareness and treatment among Asian and Hispanic individuals, and more investigation into the downstream factors that may contribute to the poor hypertension control among Black individuals.

National Trends and Disparities in Hospitalization for Acute Hypertension Among Medicare Beneficiaries (1999-2019).

BACKGROUND: In the past 2 decades, hypertension control in the US population has not improved and there are widening disparities. Little is known about progress in reducing hospitalizations for acute hypertension. METHODS: We conducted serial cross-sectional analysis of Medicare fee-for-service beneficiaries age 65 years or older between 1999 and 2019 using Medicare denominator and inpatient files. We evaluated trends in national hospitalization rates for acute hypertension overall and by demographic and geographical subgroups. We identified all beneficiaries admitted with a primary discharge diagnosis of acute hypertension on the basis of International Classification of Diseases codes. We then used a mixed effects model with a Poisson link function and state-specific random intercepts, adjusting for age, sex, race and ethnicity, and dual-eligible status, to evaluate trends in hospitalizations. RESULTS: The sample consisted of 397 238 individual Medicare fee-for-service beneficiaries. From 1999 through 2019, the annual hospitalization rates for acute hypertension increased significantly, from 51.5 to 125.9 per 100 000 beneficiary-years; the absolute increase was most pronounced among the following subgroups: adults ≥85 years (66.8-274.1), females (64.9-160.1), Black people (144.4-369.5), and Medicare/Medicaid insured (dual-eligible, 93.1-270.0). Across all subgroups, Black adults had the highest hospitalization rate in 2019, and there was a significant increase in the differences in hospitalizations between Black and White people from 1999 to 2019. Marked geographic variation was also present, with the highest hospitalization rates in the South. Among patients hospitalized for acute hypertension, the observed 30-day and 90-day all-cause mortality rates (95% CI) decreased from 2.6% (2.27-2.83) and 5.6% (5.18-5.99) to 1.7% (1.53-1.80) and 3.7% (3.45-3.84) and 30-day and 90-day all-cause readmission rates decreased from 15.7% (15.1-16.4) and 29.4% (28.6-30.2) to 11.8% (11.5-12.1) and 24.0% (23.5-24.6). CONCLUSIONS: Among Medicare fee-for-service beneficiaries age 65 years or older, hospitalization rates for acute hypertension increased substantially and significantly from 1999 to 2019. Black adults had the highest hospitalization rate in 2019 across age, sex, race and ethnicity, and dual-eligible strata. There was significant national variation, with the highest rates generally in the South.

Trends and Predictors of Use of Digital Health Technology in the United States.

BACKGROUND: Digital health technology is becoming central to health care. A better understanding of the trends and predictors of its use could reflect how people engage with the health care system and manage their health care needs. METHODS: Using data from the National Health Interview Survey for years 2011 to 2018, we assessed the use of digital health technology among individuals aged ≥18 years in the United States across 2 domains: 1) search for health information online and 2) interaction with health care providers (eg, fill a prescription, schedule a medical appointment, or communicate with health care providers). RESULTS: Our study included 253,829 individuals; representing nearly 237 million adults in the United States annually; mean age 49.6 years (SD 18.4); 51.8% women; and 65.9% non-Hispanic white individuals. Overall, 49.2% of individuals reported searching for health information online and 18.5% reported at least 1 technology-based interaction with the health care system. Between 2011 and 2018, the proportion who searched for health information online increased from 46.5% to 55.3% (P < .001), whereas the proportion who used technology to interact with the health care system increased from 12.5% to 27.4% (P < .001). Although technology-based interaction with the health care system increased across most subgroups, there were significant disparities in the extent of increase across clinical and sociodemographic subgroups. CONCLUSIONS: The use of digital health technologies increased between 2011 and 2018, however, the uptake of these technologies has been unequal across subgroups. Future innovations and strategies should focus on expanding the reach of digital heath technology across all subgroups of society to ensure that its expansion does not exacerbate the existing health inequalities.

Assessment of Prevalence, Awareness, and Characteristics of Isolated Systolic Hypertension Among Younger and Middle-Aged Adults in China.

Importance: Isolated systolic hypertension (ISH) is increasing in prevalence among young and middle-aged adults. However, most studies of ISH are limited to older individuals, and a substantial knowledge gap exists regarding younger adults with ISH. Objective: To assess the prevalence, awareness, and characteristics of ISH among younger and middle-aged adults in China. Design, Setting, and Participants: This cross-sectional study was performed as part of the China Patient-Centered Evaluative Assessment of Cardiac Events Million Persons Project, which enrolled 3.1 million community residents aged 35 to 75 years from all of the 31 provinces in China between December 15, 2014, and May 15, 2019. The present analysis included only participants younger than 50 years. Data were analyzed from May to November 2019. Main Outcomes and Measures: Prevalence and awareness of ISH (defined as systolic blood pressure of 140 mm Hg or higher and diastolic blood pressure of less than 90 mm Hg) and individual characteristics of participants with ISH. Results: Among 898 929 participants aged 35 to 49 years, the mean (SD) age was 43.8 (3.9) years; 548 657 participants (61.0%) were women, and 235 138 participants (26.2%) had hypertension. Of those with hypertension, 62 819 participants (26.7%; 95% CI, 26.5%-26.9%) had ISH (mean [SD] age, 45.0 [3.5] years; 41 417 women [65.9%]), and 54 463 of those with ISH (86.7%; 95% CI, 86.4%-87.0%) had not received treatment. The prevalence of ISH was higher among individuals who were older, were female, were farmers, resided in the eastern region of China, and had an educational level of primary school or lower. Women and older individuals were more likely to have ISH than to be normotensive or to have other hypertension subtypes. Participants who were obese, currently used alcohol, had diabetes, and experienced previous cardiovascular events were more likely to have other types of hypertension and less likely to have normotension than to have ISH. Among the 54 463 participants with ISH who had not received treatment, only 3682 individuals (6.8%; 95% CI, 6.6%-7.0%) were aware of having hypertension, and awareness rates remained low even among those with systolic blood pressure of 160 mm Hg or higher (7135 individuals [13.1%; 95% CI, 12.4%-13.9%]). Conclusions and Relevance: In this study, ISH was identified in 1 of 4 young and middle-aged adults with hypertension in China, most of whom remained unaware of having hypertension. These results highlight the increasing need for better guidance regarding the management of ISH in this population.

Quality of informed consent documents among US. hospitals: a cross-sectional study.

OBJECTIVE: To determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents. DESIGN: Retrospective observational study of informed consent documents. SETTING: 25 US hospitals, diverse in size and geographical region. COHORT: Among Medicare fee-for-service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample was representative of the procedure types performed at each hospital. PRIMARY OUTCOME: The outcome was hospital quality of informed consent documents, assessed by two independent raters using an eight-item instrument previously developed for this measure and scored on a scale of 0-20, with 20 representing the highest quality. The outcome was reported as the mean hospital document score and the proportion of documents meeting a quality threshold of 10. Reliability of the hospital score was determined based on subsets of randomly selected documents; face validity was assessed using stakeholder feedback. RESULTS: Among 2480 informed consent documents from 25 hospitals, mean hospital scores ranged from 0.6 (95% CI 0.3 to 0.9) to 10.8 (95% CI 10.0 to 11.6). Most hospitals had at least one document score at least 10 out of 20 points, but only two hospitals had >50% of their documents score above a 10-point threshold. The Spearman correlation of the measures score was 0.92. Stakeholders reported that the measure was important, though some felt it did not go far enough to assess informed consent quality. CONCLUSION: All hospitals performed poorly on a measure of informed consent document quality, though there was some variation across hospitals. Measuring the quality of hospital's informed consent documents can serve as a first step in driving attention to gaps in quality.

Financial barriers in accessing medical care for peripheral artery disease are associated with delay of presentation and adverse health status outcomes in the United States.

Patient-reported difficulties in affording health care and their association with health status outcomes in peripheral artery disease (PAD) have never been studied. We sought to determine whether financial barriers affected PAD symptoms at presentation, treatment patterns, and patient-reported health status in the year following presentation. A total of 797 United States (US) patients with PAD were identified from the Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study, a prospective, multicenter registry of patients presenting to vascular specialty clinics with PAD. Financial barriers were defined as a composite of no insurance and underinsurance. Disease-specific health status was measured by Peripheral Artery Questionnaire (PAQ) and general health-related quality of life was measured by EuroQol 5 (EQ5D) dimensions at presentation and at 3, 6, and 12 months of follow-up. Among 797 US patients, 21% (n = 165) of patients reported financial barriers. Patients with financial barriers presented at an earlier age (64 ± 9.5 vs 70 ± 9.4 years), with longer duration of symptoms (59% vs 49%) (all p ⩽ 0.05), were more depressed and had higher levels of perceived stress and anxiety. After multivariable adjustment, health status was worse at presentation in patients with financial barriers (PAQ: -7.0 [-10.7, -3.4]; p < 0.001 and EQ5D: -9.2 [-12.74, -5.8]; p < 0.001) as well as through 12 months of follow-up (PAQ: -8.4 [-13.0, -3.8]; p < 0.001 and EQ5D: -9.7 [-13.2, -6.2]; p < 0.001). In conclusion, financial barriers are associated with later presentation as well as poorer health status at presentation and at 12 months. ClinicalTrials.gov Identifier: NCT01419080.