Association Between Mental Health Burden, Clinical Presentation, and Outcomes in Individuals With Symptomatic Peripheral Artery Disease: A Scientific Statement From the American Heart Association.

Along with the rising burden of peripheral artery disease (PAD), mental health concerns are increasingly being recognized as a comorbidity to address in the chronic disease management of symptomatic PAD. Apart from a high prevalence of comorbid mental health conditions, the role of pain and changing health behaviors and the broader impacts of illness and adaptation to living with PAD require specialized behavioral health expertise. This scientific statement builds a case that this expertise should be integrated within the multidisciplinary PAD team. Furthermore, areas such as cognitive dysfunction and palliative care are highlighted as needing psychological interventions. Although much of the evidence of the efficacy of psychological and psychotropic interventions has been extrapolated from other cardiovascular populations, evidence for the role of psychological interventions for behavior change, for example, uptake of exercise regimens, is increasingly being accrued within PAD. Areas for behavioral health needs and interactions with PAD treatment are discussed, including the use of opioids, depression management, anxiety and stress reduction interventions, the use of benzodiazepines and antidepressants, smoking cessation, rehabilitation trajectories after amputation, and the role of cognitive decline for PAD treatment and outcomes. A case summary highlights the stigma around mental health and vascular disease and the fragmentation of care. This scientific statement provides remarks for building a road map for integrated behavioral PAD care and potential solutions to overcome these barriers. Instrumental to reaching these changes are interprofessional advocacy efforts and initiatives that help break down the stigma around mental health and promote evidence-based collaborative, nonhierarchical, and multidisciplinary PAD care.

Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment: A Scientific Statement From the American Heart Association.

Peripheral artery disease (PAD) is chronic in nature, and individualized chronic disease management is a central focus of care. To accommodate this reality, tools to measure the impact and quality of the PAD care delivered are necessary. Patient-reported outcomes (PROs) and instruments to measure them, that is, PRO measures, have been well studied in the research and clinical trial context, but a shift toward integrating them into clinical practice has yet to take place. A framework to use PRO measures as indicators of the quality of PAD care delivered, that is, PRO performance measures (PRO-PMs), is provided in this scientific statement. Measurement goals to consider by PAD clinical phenotypes are provided, as well as an overview of potential benefits of adopting PRO-PMs in the clinical practice of PAD care, including reducing unwanted variability and promoting health equity. A central discussion with considerations for risk adjustment of PRO-PMs, individualized PAD care, and the need for patient engagement strategies is offered. Furthermore, necessary conditions in terms of required competencies and training to handle PRO-PM data are discussed because the interpretation and handling of these data come with great responsibility and consequences for designing care that adopts a broader framework of risk that goes beyond the inclusion of biomedical variables. To conclude, health system perspectives and an agenda to reach the next steps in the implementation of PRO-PMs in PAD care are offered.

Treatment decisions for patients with peripheral artery disease and symptoms of claudication: Development process and alpha testing of the SHOW-ME PAD decision aid.

Patients with peripheral artery disease (PAD) face a range of treatment options to improve survival and quality of life. An evidence-based shared decision-making tool (brochure, website, and recorded patient vignettes) for patients with new or worsening claudication symptoms was created using mixed methods and following the International Patient Decision Aids Standards (IPDAS) criteria. We reviewed literature and collected qualitative input from patients (n = 28) and clinicians (n = 34) to identify decisional needs, barriers, outcomes, knowledge, and preferences related to claudication treatment, along with input on implementation logistics from 59 patients and 27 clinicians. A prototype decision aid was developed and tested through a survey administered to 20 patients with PAD and 23 clinicians. Patients identified invasive treatment options (endovascular or surgical revascularization), non-invasive treatments (supervised exercise therapy, claudication medications), and combinations of these as key decisions. A total of 65% of clinicians thought the brochure would be useful for medical decision-making, an additional 30% with suggested improvements. For patients, those percentages were 75% and 25%, respectively. For the website, 76.5% of clinicians and 85.7% of patients thought it would be useful; an additional 17.6% of clinicians and 14.3% of patients thought it would be useful, with improvements. Suggestions were incorporated in the final version. The first prototype was well-received among patients and clinicians. The next step is to implement the tool in a PAD specialty care setting to evaluate its impact on patient knowledge, engagement, and decisional quality. ClinicalTrials.gov Identifier: NCT03190382.

Validation of the Seattle angina questionnaire in women with ischemic heart disease.

BACKGROUND: Although the Seattle Angina Questionnaire (SAQ) has been widely used to assess disease-specific health status in patients with ischemic heart disease, it was originally developed in a predominantly male population and its validity in women has been questioned. METHODS: Using data from 8892 men and 4013 women across 2 multicenter trials and 5 registries, we assessed the construct validity, test-retest reliability, responsiveness to clinical change, and predictive validity of the SAQ Summary Score (SS) and its 5 subdomains (Physical Limitation (PL), Anginal Stability (AS), Angina Frequency (AF), Treatment Satisfaction (TS), and Quality of Life (QoL)) separately in men and women. RESULTS: Comparable correlations of the SAQ SS with Canadian Cardiovascular Society class was demonstrated in both men and women (-0.48 for men, -0.46 for women). Similar correlations between the SAQ PL scale with treadmill exercise duration and Short Form-12 (SF-12) Physical Component Summary were observed in women and men (0.34-0.63 and 0.40-0.63, respectively). SAQ AS scores were significantly lower for both men and women with acute syndromes compared with 1 month later. The SAQ AF scale was strongly correlated with daily angina diaries (0.62 for men and 0.66 for women). The SAQ QoL scores were moderately correlated with the EQ5D visual analog scale and SF-12 general health question in men (0.43-0.50) and women (0.33-0.39). All SAQ scales demonstrated excellent reliability (intraclass correlation ≥0.78) in both men and women with stable CAD and were very sensitive to change after percutaneous coronary intervention (≥15-point difference in scores, standardized response mean ≥ 0.67). The SAQ SS was similarly predictive of 1-year mortality and cardiac re-hospitalizations for both men and women. CONCLUSION: The SAQ demonstrates similar psychometric properties in men and women with CAD. These findings provide evidence for validity of the SAQ in assessing women with IHD.

Understanding physician-level barriers to the use of individualized risk estimates in percutaneous coronary intervention.

BACKGROUND: The foundation of precision medicine is the ability to tailor therapy based upon the expected risks and benefits of treatment for each individual patient. In a prior study, we implemented a software platform, ePRISM, to execute validated risk-stratification models for patients undergoing percutaneous coronary intervention and found substantial variability in the use of the personalized estimates to tailor care. A better understanding of physicians' perspectives about the use of individualized risk-estimates is needed to overcome barriers to their adoption. METHODS: In a qualitative research study, we conducted interviews, in-person or by telephone, with 27 physicians at 8 centers that used ePRISM until thematic saturation occurred. Data were coded using descriptive content analyses. RESULTS: Three major themes emerged among physicians who did not use ePRISM to support decision making: (1) "Experience versus Evidence," physicians' preference to rely upon personal experience and subjective assessments rather than objective risk estimates; (2) "Omission of Therapy," the perception that the use of risk models leads to unacceptable omission of potentially beneficial therapy; and (3) "Unnecessary Information," the opinion that information derived from risk models is not needed because physicians' decision making is already sound and they already know the information. CONCLUSIONS: Barriers to the use of risk models in clinical practice include physicians' perceptions that their experience is sufficient, that models may lead to omission of therapy in patients that may benefit from therapy, and that they already provide good care. Anticipating and overcoming these barriers may improve the adoption of precision medicine.

Improving the process of informed consent for percutaneous coronary intervention: patient outcomes from the Patient Risk Information Services Manager (ePRISM) study.

BACKGROUND: While the process of informed consent is designed to transfer knowledge of the risks and benefits of treatment and to engage patients in shared medical decision-making, this is poorly done in routine clinical care. We assessed the impact of a novel informed consent form for percutaneous coronary intervention (PCI) that is more simply written, includes images of the procedure, and embeds individualized estimates of outcomes on multiple domains of successful informed consent and shared decision-making. METHODS: We interviewed 590 PCI patients receiving traditional consent documents and 527 patients receiving novel ePRISM consents at 9 US centers and compared patients' perceptions, knowledge transfer, and engagement in medical decision-making. Heterogeneity across sites was assessed and adjusted for using hierarchical models. RESULTS: Site-adjusted analyses revealed more frequent review (72% for ePRISM vs 45% for original consents) and better understanding of the ePRISM consents (ORs=1.8-3.0, depending upon the outcome) with marked heterogeneity across sites (median relative difference [MRD] in the ORs of ePRISM's effect =2-3.2). Patients receiving ePRISM consents better understood the purposes and risks of the procedure (ORs=1.9-3.9, MRDs=1.1-6.2), engaged more in shared decision-making (proportional OR=2.1 [95% CI=1.02-4.4], MRD=2.2) and discussed stent options with their physicians (58% vs. 31%; site-adjusted odds ratio=2.7 [95% CI=1.2, 6.3], MRD=2.6) more often. CONCLUSIONS: A personalized consent document improved the process of informed consent and shared decision-making. Marked heterogeneity across hospitals highlights that consent documents are but one aspect of engaging patients in understanding and participating in treatment.

High connectivity across the fragmented chemosynthetic ecosystems of the deep Atlantic Equatorial Belt: efficient dispersal mechanisms or questionable endemism?

Chemosynthetic ecosystems are distributed worldwide in fragmented habitats harbouring seemingly highly specialized communities. Yet, shared taxa have been reported from highly distant chemosynthetic communities. These habitats are distributed in distinct biogeographical regions, one of these being the so-called Atlantic Equatorial Belt (AEB). Here, we combined genetic data (COI) from several taxa to assess the possible existence of cryptic or synonymous species and to detect the possible occurrence of contemporary gene flow among populations of chemosynthetic species located on both sides of the Atlantic. Several Evolutionary Significant Units (ESUs) of Alvinocarididae shrimp and Vesicomyidae bivalves were found to be shared across seeps of the AEB. Some were also common to hydrothermal vent communities of the Mid-Atlantic Ridge (MAR), encompassing taxa morphologically described as distinct species or even genera. The hypothesis of current or very recent large-scale gene flow among seeps and vents was supported by microsatellite analysis of the shrimp species Alvinocaris muricola/Alvinocaris markensis across the AEB and MAR. Two nonmutually exclusive hypotheses may explain these findings. The dispersion of larvae or adults following strong deep-sea currents, possibly combined with biochemical cues influencing the duration of larval development and timing of metamorphosis, may result in large-scale effective migration among distant spots scattered on the oceanic seafloor. Alternatively, these results may arise from the prevailing lack of knowledge on the ocean seabed, apart from emblematic ecosystems (chemosynthetic ecosystems, coral reefs or seamounts), where the widespread classification of endemism associated with many chemosynthetic taxa might hide wider distributions in overlooked parts of the deep sea.

What distinguishes top-performing hospitals in acute myocardial infarction mortality rates? A qualitative study.

BACKGROUND: Mortality rates for patients with acute myocardial infarction (AMI) vary substantially across hospitals, even when adjusted for patient severity; however, little is known about hospital factors that may influence this variation. OBJECTIVE: To identify factors that may be related to better performance in AMI care, as measured by risk-standardized mortality rates. DESIGN: Qualitative study that used site visits and in-depth interviews. SETTING: Eleven U.S. hospitals that ranked in either the top or the bottom 5% in risk-standardized mortality rates for 2 recent years of data from the Centers for Medicare & Medicaid Services (2005 to 2006 and 2006 to 2007), with diversity among hospitals in key characteristics. PARTICIPANTS: 158 members of hospital staff, all of whom were involved with AMI care at the 11 hospitals. MEASUREMENTS: Site visits and in-depth interviews conducted with hospital staff during 2009. A multidisciplinary team performed analyses by using the constant comparative method. RESULTS: Hospitals in the high-performing and low-performing groups differed substantially in the domains of organizational values and goals, senior management involvement, broad staff presence and expertise in AMI care, communication and coordination among groups, and problem solving and learning. Participants described diverse protocols or processes for AMI care (such as rapid response teams, clinical guidelines, use of hospitalists, and medication reconciliation); however, these did not systematically differentiate high-performing from low-performing hospitals. LIMITATION: The qualitative design informed the generation of hypotheses, and statistical associations could not be assessed. CONCLUSION: High-performing hospitals were characterized by an organizational culture that supported efforts to improve AMI care across the hospital. Evidence-based protocols and processes, although important, may not be sufficient for achieving high hospital performance in care for patients with AMI. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality, United Health Foundation, and the Commonwealth Fund.

Medication Discussion Questions (MedDQ): developing a guide to facilitate patient-clinician communication about heart medications.

BACKGROUND AND RESEARCH OBJECTIVE: Adherence to evidence-based therapies has emerged as one of the great challenges of translating discoveries to clinical care to optimize patient outcomes. In particular, nonadherence to lifesaving medications continues to trouble health care systems. We conducted a series of studies to investigate why cardiac patients stop life-sustaining medications and to develop a tool to proactively address medication adherence issues. We could find no available preventive tools for communicating with patients about their medications in the clinical setting. In this article, we summarize the process of developing such a tool. SUBJECTS AND METHODS: We used a mixed-methods approach in a series of studies that included examining quantitative data from a large patient registry, conducting in-depth qualitative patient interviews, creating items representative of the qualitative findings, pilot testing items with heart patients, surveying an expert panel to establish content validity, and conducting in-depth interviews with health care providers to assess implementation opportunities. RESULTS AND CONCLUSIONS: Patient interviews revealed that patients' values and beliefs, barriers to treatment, and prior medication-taking behavior were of primary importance in understanding medication discontinuance. Pilot testing, expert panel review, and an implementation feasibility evaluation resulted in an 11-item communication guide to be used in a variety of health care settings. Clinicians need an efficient way of systematically communicating with patients about heart medications to identify barriers and to initiate preventive interventions when patients report barriers or challenges to medication adherence.

Development and Piloting of a Patient-Centered Report Design for Stress Myocardial Perfusion Imaging Results.

Importance: The management of coronary disease epitomizes the call to better engage patients in shared medical decision-making. Myocardial perfusion imaging (MPI) is the foundation of diagnosis, risk stratification, and subsequent therapy; however, MPI reports are currently interpretable by specialists but not patients. Objective: To design and test a patient-centered report for stress MPI test results. Design, Setting, and Participants: This qualitative study of outpatients who underwent an MPI stress test and clinicians used a mixed methods approach. Phase 1 (December 2018 to July 2019) used qualitative methods to design a patient-centered reporting tool, with 5 focus groups with 36 patients and 2 focus groups with 27 clinicians. Phase 2 (June to September 2019) consisted of pilot testing the reporting tool with feedback from a structured survey given to patients who received MPI reports before and after implementing the tool. Main Outcomes and Measures: Key themes around patient experiences with the current MPI reporting and their desire for a more useful report were identified, which led to a sample reporting tool after serial iterations with feedback. Differences in patient knowledge and engagement were assessed between patients before and after implementation of the new reporting tool using χ2 tests. Results: From patient focus groups (26 patients; mean [SD] age, 66.3 [9.6] years, 9 [35%] women), 3 themes on the inadequacies of current MPI reporting were identified: (1) inconsistent delivery of results, (2) use of medical jargon, and (3) unclear posttest course. We identified 5 themes for a more patient-centered MPI report: desire for written information, discussion of the report with medical personnel, presentation of results in simple language with use of visual graphics, comparisons with normal results, and personalized risk estimates. In a pilot survey with 123 patients split into a pre-implementation group (69 patients; mean [SD] age, 68.2 [8.5] years; 27 [51%] women) and a postimplementation group (54 patients; mean [SD] age, 66.4 [8.7] years; 30 [56%] women), the patient-centered report led to more patients reading the entire report (45 [83%] vs 46 [67%]; P = .04) and improved knowledge of future risk of cardiac events (41 [76%] vs 20 [29%]; P < .001). There was also a numerically higher percentage of patients who found the report easy to read (45 [83%] vs 44 [68%]; P = .05) and understand (42 [78%] vs 43 [66%]; P = .16), although these results were not statistically significant. Conclusions and Relevance: This study identified key elements of a patient-centered report design for stress MPI test results, which improved patient engagement and knowledge. These preliminary data support further implementation and study of a more patient-centered MPI report.

The prognostic importance of worsening renal function during an acute myocardial infarction on long-term mortality.

BACKGROUND: Although an acute worsening in renal function (WRF) commonly occurs among patients hospitalized for acute myocardial infarction (AMI), its long-term prognostic significance is unknown. We examined predictors of WRF and its association with 4-year mortality. METHODS: Acute myocardial infarction patients from the multicenter PREMIER study (N=2,098) who survived to hospital discharge were followed for at least 4 years. Worsening in renal function was defined as an increase in creatinine during hospitalization of ≥0.3 mg/dL above the admission value. Correlates of WRF were determined with multivariable logistic regression models and used, along with other important clinical covariates, in Cox proportional hazards models to define the independent association between WRF and mortality. RESULTS: Worsening in renal function was observed in 393 (18.7%) of AMI survivors. Diabetes, left ventricular systolic dysfunction, and a history of chronic kidney disease (documented history of renal failure with baseline creatinine>2.5 mg/dL) were independently associated with WRF. During 4-year follow-up, 386 (18.6%) patients died. Mortality was significantly higher in the WRF group (36.6% vs 14.4% in those without WRF, P<.001). After adjusting for other factors associated with WRF and long-term mortality, including baseline creatinine, WRF was independently associated with a higher risk of death (hazard ratio=1.64, 95% CI 1.23-2.19). CONCLUSIONS: Worsening in renal function occurs in approximately 1 of 6 AMI survivors and is independently associated with an adverse long-term prognosis. Further studies on interventions to minimize WRF or to more aggressively treat patients developing WRF should be tested.

Rates and Predictors of Patient Underreporting of Hospitalizations During Follow-Up After Acute Myocardial Infarction: An Assessment From the TRIUMPH Study.

BACKGROUND: Many clinical investigations depend on participant self-report as a principal method of identifying health care events. If self-report is used as the trigger to collect and adjudicate medical records, any event that is not reported by the patient will be missed by the investigators, reducing the power of the study and misrepresenting the risk of its participants. We sought to determine the rates and predictors of underreporting hospitalization events during the follow-up period of a prospective study of patients hospitalized with an acute myocardial infarction. METHODS AND RESULTS: The TRIUMPH (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status) registry, a longitudinal multicenter cohort study of people with acute myocardial infarction in the United States, queried patients for hospitalization events during interviews at 1, 6, and 12 months. To validate these self-reports, medical records for all events at every hospital where the patient reported receiving care were acquired for adjudication, not just those for the reported events. Of the 4340 participants in TRIUMPH, 1209 (28%) reported at least one hospitalization. After medical records abstraction and adjudication, we identified 1086 hospitalizations from 639 participants (60.2±12 years of age, 38.2% women). Of these hospitalizations, 346 (31.9%) were underreported by the participants. Rates of underreporting ranged from 22.5% to 55.6% based on different patient characteristics. The odds of underreporting were highest for those not currently working (adjusted odds ratio, 1.66 [95% CI, 1.04-2.63]), lowest for those married (adjusted odds ratio, 0.50 [95% CI, 0.33-0.76]), and increased the longer the elapsed time between the admission and the patient's follow-up interview (adjusted odds ratio per month, 1.16 [95% CI, 1.08-1.24]). There was a substantial within-individual variation on the accuracy of reporting. CONCLUSIONS: Hospitalizations after acute myocardial infarction are commonly underreported in interviews and should not be used alone to determine event rates in clinical studies.

Risk factor management after myocardial infarction: reported adherence and outcomes.

BACKGROUND: Providing patients with documented discharge instructions is a performance measure of health care quality. It is not well known how often cardiac patients comply with the list of instructions or what their association is with health status outcomes after an acute myocardial infarction. METHODS: Acute myocardial infarction patients (N = 2,498) were prospectively enrolled into a 19-center study and asked, at 1 month, if they had recalled receiving instructions at discharge on any of the 13 secondary prevention behaviors (eg, exercise, medications, diet, and smoking). Adherence, defined as the percentage of relevant activities patients reported adhering to at 1 month, was grouped into 4 categories: poor (0%-49%), partial (50%-74%), careful (75%-99%), and very careful (100%). RESULTS: A total of 2,046 patients completed 1-month interviews and received instruction on at least 1 risk factor management (RFM) behavior. Very careful adherence at 1-month was reported most frequently with "taking medications as prescribed" (94%). In multivariable-adjusted models, patients who reported being poorly adherent were 58% more likely to report angina at 1 year as compared with those who very carefully followed RFM (relative risk 1.58, 95% CI 1.05-2.37). There was no independent association between RFM behavior and quality of life, physical functioning, rehospitalization, or mortality. CONCLUSIONS: There is substantial variation in the types of RFM to which acute myocardial infarction patients adhere. In aggregate, stronger adherence was associated with less angina at 1 year. More research is needed to understand adherence patterns and its association with outcomes.

Exploring patients' reasons for discontinuance of heart medications.

BACKGROUND: Despite the importance of secondary prevention, nonadherence rates for patients with myocardial infarction (MI) range from 13% to 60% for prescribed, evidence-based medicines. Although rates and consequences of discontinuance vary for different medications, the existing literature provides little insight into reasons for discontinuance. OBJECTIVE: To address this gap, we explored clopidogrel and cholesterol-lowering therapy (CLT) discontinuance after an MI to understand patients' reasons for stopping these 2 medications. METHODS: In this qualitative descriptive study, 2 groups of patients who stopped a heart medication-either clopidogrel or CLT-were recruited from a prospective MI registry. Patients who discontinued CLT (n = 29) or clopidogrel (n = 11) were interviewed within 18 months of hospitalization. Patients were recruited and interviewed until data saturation was achieved. The Health Belief Model was used as an organizing framework in analyzing and coding the narrative data. The codes were then summarized for each group and compared to identify similarities and differences in reasons for CLT and clopidogrel discontinuance. RESULTS AND CONCLUSIONS: The most common reason for CLT discontinuance was adverse effects that were painful and interfered with daily life. Less common reasons for discontinuance were prescription confusion, cost, mistrust in medicines/healthcare system, and preference for alternative therapies. Reasons for clopidogrel discontinuance were duration confusion, adverse effects, and cost. Although doctors stopped patients' clopidogrel in preparation for surgery, doctors conceded to discontinuance of CLT for patients who experienced adverse effects after trying 2 to 3 different CLTs. Patients who discontinued CLT were more likely to believe that they did not need the treatment than do patients who discontinued clopidogrel. Clinicians should be aware that reasons may vary across patients and medication class for prematurely stopping therapy; thus, proactive interventions should be targeted to address these differences. Identifying at-risk patients for targeted interventions to prevent premature cardiac medication discontinuation is vital.

Neonatologists' Attitudes About Diagnostic Whole-Genome Sequencing in the NICU.

Using focus group methodology, we studied the attitudes of neonatologists regarding diagnostic rapid genome sequencing for newborns who were critically ill in a NICU. One focus group took place within the first year after whole-genome sequencing testing became available, and another focus group took place 3 years later. Focus groups were audiotaped, transcribed, and analyzed by using standard techniques of grounded theory. Different analysts coded them for themes. The analysts then discussed differences and agreed on major themes. Twelve doctors participated in the first focus group, and 9 doctors participated in the second; 62% were attending physicians, and the rest were fellows. There were 14 women and 7 men. We did not collect any other demographic information on participants. Surprisingly, we found few differences between the earlier focus group and the later one. Comments were categorized as falling into 4 domains: (1) uncertainty about the interpretation of results, (2) issues about parental consent and limits on their right to know genomic information, (3) different opinions about whether and how genomic results could be clinically useful, and (4) potential harms of genomic testing.

What eye-tracking methods can reveal about the role of information format in decision-aid processing: an exploratory study.

OBJECTIVE: Decision tools can assist patients and families in making informed choices about treatment options. However, information format can influence understanding of treatment options and subsequent treatment decisions, so it is critical to identify formats that support clear and accurate communication. METHOD: Forty-five older adults made a hypothetical treatment decision about rt-PA therapy for stroke while viewing risk information presented in one of three graph formats (bar, stacked bar, or iconic array). We investigated decisional uncertainty, study time and memory accuracy as a function of graph format. Eye tracking methods explored format-related differences in graph processing. RESULTS: Decisional uncertainty was higher after studying the bar graph, compared to the stacked bar or iconic graph. The bar graph was also associated with poorer memory and longer overall study time. Eye-tracking indicated that graph information was processed in a different order and to a different extent for the three graph types. CONCLUSION: Understanding how people process information in decision aids is critical for clear communication with decision-makers. PATIENT IMPLICATIONS: Format has been shown to impact information processing, and eye-tracking may be a useful tool to understand these format differences and their implications, and to guide the design of decision aids to optimize communication.

Developing and Testing a Personalized, Evidence-Based, Shared Decision-Making Tool for Stent Selection in Percutaneous Coronary Intervention Using a Pre-Post Study Design.

Background Drug-eluting stents reduce the risk of restenosis in patients undergoing percutaneous coronary intervention, but their use necessitates prolonged dual antiplatelet therapy, which increases costs and bleeding risk, and which may delay elective surgeries. While >80% of patients in the United States receive drug-eluting stents, less than a third report that their physicians discussed options with them. Methods and Results An individualized shared decision-making (SDM) tool for stent selection was designed and implemented at 2 US hospitals. In the postimplementation phase, all patients received the SDM tool before their procedure, with or without decision coaching from a trained nurse. All patients were interviewed with respect to their knowledge of stents, their participation in SDM, and their stent preference. Between May 2014 and December 2016, 332 patients not receiving the SDM tool, 113 receiving the SDM tool with coaching, and 136 receiving the tool without coaching were interviewed. Patients receiving the SDM tool + coaching, as compared with usual care, demonstrated higher knowledge scores (mean difference +1.8; P<0.001), reported more frequent participation in SDM (odds ratio=2.96; P<0.001), and were more likely to state a stent preference (odds ratio=2.00; P<0.001). No significant differences were observed between the use of the SDM tool without coaching and usual care. For patients who voiced a stent preference, concordance between stent desired and stent received was 98% for patients who preferred a drug-eluting stent and 50% for patients who preferred a bare metal stent. The SDM tool (with or without coaching) had no impact on stent selection or concordance. Conclusions An SDM tool for stent selection was associated with improvements in patient knowledge and SDM only when accompanied by decision coaching. However, the SDM tool (with or without coaching) had no impact on stent selection or concordance between patients' stent preference and stent received, suggesting that physician-level barriers to SDM may exist. Clinical Trial Information URL: https://www.clinicaltrials.gov . Unique Identifier: NCT02046902.

Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry.

BACKGROUND: Although drug-eluting stents (DES) significantly reduce restenosis, they require 3 to 6 months of thienopyridine therapy to prevent stent thrombosis. The rate and consequences of prematurely discontinuing thienopyridine therapy after DES placement for acute myocardial infarction (MI) are unknown. METHODS AND RESULTS: We used prospectively collected data from a 19-center study of MI patients to examine the prevalence and predictors of thienopyridine discontinuation 30 days after DES treatment. We then compared the mortality and cardiac hospitalization rates for the next 11 months between those who stopped and those who continued thienopyridine therapy. Among 500 DES-treated MI patients who were discharged on thienopyridine therapy, 68 (13.6%) stopped therapy within 30 days. Those who stopped were older, less likely to have completed high school or be married, more likely to avoid health care because of cost, and more likely to have had preexisting cardiovascular disease or anemia at presentation. They were also less likely to have received discharge instructions about their medications or a cardiac rehabilitation referral. Patients who stopped thienopyridine therapy by 30 days were more likely to die during the next 11 months (7.5% versus 0.7%, P<0.0001; adjusted hazard ratio=9.0; 95% confidence interval=1.3 to 60.6) and to be rehospitalized (23% versus 14%, P=0.08; adjusted hazard ratio=1.5; 95% confidence interval=0.78 to 3.0). CONCLUSIONS: Almost 1 in 7 MI patients who received a DES were no longer taking thienopyridines by 30 days. Prematurely stopping thienopyridine therapy was strongly associated with subsequent mortality. Strategies to improve the use of thienopyridines are needed to optimize the outcomes of MI patients treated with DES.

Self-reported use of complementary and alternative medicine in patients with previous acute coronary syndrome.

Complementary and alternative medicine (CAM) use is common in patients with cardiovascular disease. Although numerous efforts have sought to understand CAM types and the prevalence of CAM, whether patients preferentially use CAM instead of evidence-based therapies is unknown. Self-reported use of CAM and evidence-based therapies in a prospective registry of hospitalized patients with acute coronary syndrome from March 1, 2001 to October 31, 2002 were examined. Poisson regression models were used to assess whether CAM use was independently associated with lower rates of aspirin, beta-blocker, and statin use in 596 patients with established coronary artery disease (CAD). Overall, CAM use was 19% in patients with CAD. Higher proportions of patients who used CAM were non-Caucasian (31% vs 12%), uninsured (12% vs 7%), economically burdened (58% vs 29%), and had depression (13% vs 6%, p<0.05 for all). Patients who used CAM were more likely to use beta blockers (64% vs 46%, p=0.008) and as likely to use aspirin (73% vs 74%, p=0.90) and statins (71% vs 68%, p=0.76) as non-CAM users. Adjusting for demographic and clinical factors did not change results (CAM users: RR 1.27, 95% confidence interval [CI] 1.01 to 1.60 for using beta blockers, RR 0.97, 95% CI 0.85 to 1.11 for using aspirin, and RR 1.05, 95% CI 0.87 to 1.28 for using statins). In conclusion, although CAM users with established CAD have worse socioeconomic status than nonusers, we found no evidence that they were less compliant with evidence-based therapies.

Does health status differ between men and women in early recovery after myocardial infarction?

BACKGROUND: Although much attention has been given to survival after myocardial infarction (MI), little is known about sex differences in health status (symptoms, function, and quality of life). A particularly critical moment to assess health status following an MI is early after discharge when patients have resumed routine activities and when additional treatments may be offered to those with residual angina or quality of life limitations. METHODS: We used multivariable Poisson and linear regression models to examine differences in 30-day health status by sex in a cohort of 2096 MI patients enrolled in a 19-center Prospective Registry Evaluating Myocardial Infarction: Events and Recovery (PREMIER). RESULTS: Women (32% of the cohort) were older and less likely to be white, married, or treated with coronary revascularization. They were more likely to have had a non-ST segment elevation MI, diabetes, hypertension, heart failure, chronic lung disease, and worse health status at admission. Risk-adjusted multivariable models suggest women were slightly more likely to have angina (RR 1.06, 95% CI 1.0, 1.14, p = 0.06), worse quality of life (difference in SAQ score = -4.36 points, 95% CI -5.44, -3.27 points, p = <0.001) and poorer physical functioning (difference in SF-12 PCS = -2.55 points, 95%CI = -3.62, -1.48 points, p = <0.001) at 30 days than men. CONCLUSIONS: One in four patients experienced angina 1 month after their MI, and women had a slightly greater prevalence than men. The physical function and quality of life of women 30 days after an MI is similar to or worse than that of men.