Advancing health equity in patients with heart failure (HF) is an urgent priority. Structural inequalities and social determinants of health contribute to disparities in HF incidence, clinical outcomes, and access to therapies.¹ However, isolating the best methods to study these inequalities and intervening upon identified targets is complex. Because patterns of inequity are interrelated and tightly connected, focusing on any individual domain in isolation will inevitably provide an incomplete picture of the scope of the problem. While clinical practice guidelines clarify optimal medical and device-based management for patients across the HF spectrum, it is less clear how to integrate consideration of social determinants of health into implementation of treatment algorithms. Moreover, attempts to reduce inequity in one domain can potentially worsen disparities in another domain or even run counter to individual patients’ values and preferences, and patient-level interventions may differ substantially from policy or system-level interventions. Effective strategies to reduce inequity in HF will thus require understanding patients’ values and recognition of the interactions between different domains of inequity. To illustrate the ethical complexity around these issues, we discuss 2 well-recognized contexts where disparities exist: access to novel guideline-directed medical therapy (GDMT) and inclusion in clinical trials.

The armamentarium of treatment for HF continues to grow, and GDMT now involves more treatments than ever before. However, there are disparities in the prescription of these therapies, potentially related to novel therapies with high out-of-pocket costs.² High out-of-pocket costs disproportionately burden patients with lower socioeconomic status, who have less disposable income and are often uninsured or underinsured. Some portion of these out-of-pocket costs may be mitigated by attention to insurance formulary preferences or drug assistance programs and the use of multidisciplinary teams may help better identify savings opportunities for patients. However, even after maximizing cost-saving strategies, GDMT may simply be unaffordable or may require patients to cut back on other necessary expenses to afford GDMT, resulting in financial toxicity.³ Prescription of inferior GDMT in favor of cost considerations may disproportionately disadvantage patients from historically marginalized groups. Conducting cost discussions that help patients navigate these tradeoffs can be complex. Helping an individual patient to assess whether GDMT is worth the cost requires an understanding of the patient’s values, financial situation, and HF prognosis in the context of their other comorbidities. These discussions are often limited by time, imprecise out-of-pocket cost information, and health literacy. Furthermore, effective shared decision-making can be thwarted by biases like therapeutic inertia or cost-benefit conflation, and clinicians have limited guidance on when or how much to nudge patients to correct for these biases.⁴

The 2022 American Heart Association/American College of Cardiology/Heart Failure Society of America HF guidelines provide a class I recommendation to target social determinants of health⁵; however, they do not provide suggestions regarding what this means at an individual patient level, and population-level metrics may provide a misleading picture of whether this task is being accomplished. For example, efforts to counter therapeutic inertia by measuring clinicians’ rates of GDMT prescription or patients’ adherence to GDMT without addressing tradeoffs or encouraging substantive cost discussions can exacerbate financial toxicity. Interventions that target clinicians should ensure that patients understand both medical benefits and financial implications so that patients can make decisions that suit their values and financial situation. Health system or policy-level interventions, on the other hand, should focus on improving the affordability of GDMT by reducing out-of-pocket costs. While the former is critical in the current financial landscape, the latter is critical to help achieve equity in GDMT use, reduce disparities, and improve HF outcomes. In this respect, it is not surprising that novel HF therapies represent 3 of the first 10 medications selected by the Centers for Medicare and Medicaid Services for price negotiation via the Inflation Reduction Act.⁶

Complex inequities in HF extend to clinical research as well. Clinical trials testing novel therapies for HF are rapidly increasing; however, the longstanding problem of underrepresentation of women and patients from minoritized racial and ethnic groups in these trials persists. Failure to adequately gather data in these populations raises concerns about generalizability of findings, challenges the integrity of evidence-based treatment algorithms, and undermines engagement and trust.⁷ Acknowledging that representation matters is ethically unambiguous. Furthermore, recent data confirm that clinicians who care for diverse patients are more willing to prescribe drugs tested in racially and ethnically representative samples, and diverse patients are more likely to think a medication will be efficacious for them when it has been tested in a representative sample.⁸

Currently, there are significant efforts underway to enhance diversity in clinical trials from the Food and Drug Administration and key stakeholders within the field of cardiovascular disease.⁹ A key suggested metric for improving equity in cardiovascular trials is increasing the percent enrollment of patients from underrepresented racial and ethnic groups. However, simply increasing the percentage of underrepresented patients in clinical trials does not necessarily accomplish the ethical goals underpinning these efforts. We describe 2 ways in which these issues require more subtle ethical analysis and assessment.

First, a simple emphasis on increased inclusion may inadequately attend to the ethical complexity of this issue if important considerations of trust and engagement are ignored. Particularly in the context of contemporary and historical abuses, the health care system has proven itself untrustworthy to members of multiple minoritized communities. have long-standing concerns regarding trust in the health care system. If researchers simply target or over-sample communities with large numbers of under-represented groups, without understanding barriers to participation or taking actions to demonstrate trustworthiness, respect, and commitment to engagement, enrollment numbers could improve despite missing other important ethical goals. This may alienate already marginalized groups. Issues of mistrust, persistent socioeconomic vulnerability, and reduced access to care are rooted in the pervasive impact of structural racism on members of marginalized communities. A failure to acknowledge these broader issues could exacerbate existing tensions unless conscious efforts are made to avoid activities that could be characterized “as helicopter research.”

Second, efforts to increase diversity in clinical trials could fail to appreciate potential sources of vulnerability among potential participants. Since the 1970s, there has been a substantial emphasis on protection of individuals from vulnerable groups such as participants of lower socioeconomic status or other marginalized populations. There is increasing recognition that these notions of vulnerability may be prejudicial and not always grounded in evidence.¹⁰ For example, there has been a shift in thought about strategies such as the use of incentives to enhance research recruitment. Historically, the primary concern about offering incentives for research participation was that it would exploit or capitalize on the vulnerability of poorer individuals. Newer evidence suggests that payment may not undermine consent.¹¹ In fact, it may address barriers to participation, and it may be that appropriate payment could help to promote inclusion and justice rather than worsening distributive justice in research. This requires further study, but the right approach to this ethically contentious issue should be driven by evidence.

There are ethical considerations beyond incentives that are critical to attend to when working to expand inclusion of historically underrepresented groups. Health literacy and general familiarity with research, for example, may be lower among members of these groups. Moreover, past research on patient-provider interactions documents that clinicians spend less time with Black patients and communicate in ways that are less patient-centered.¹² Efforts to increase inclusion must thus ensure that consent processes are appropriately designed to promote understanding of a trial’s benefits and risks and that they do not differentially accomplish that goal among potential participants from different races, ethnicities, socioeconomic strata, or other demographic factors. Similarly, individuals may consider enrolling in a trial of a novel therapy largely because an existing therapy is prohibitively expensive. Ensuring that these trials are not exploitative is critical. All of these issues are complex, and we do not propose specific solutions here beyond genuine engagement and partnership with groups and communities who are being recruited and increasing diversity in trialists.¹³ Our primary goal is to highlight the fact that while increasing inclusion of diverse populations may be ethically appropriate and important, the emphasis on inclusion cannot come at the expense of failing to recognize other important ethical considerations related to underlying inequities.

We highlight these 2 cases because they exemplify ways in which advancing equity is complex, multifaceted, and highly contextualized. They also illustrate the potential for unintended consequences if approaches to advancing or measuring equity are insufficiently nuanced. In the case of GDMT for HF, advancing equity in individual clinician-patient encounters necessitates engagement with patients and understanding of their lived experiences and values. Successful implementation of patient-centered care may appropriately lead some patients with financial limitations to choose less expensive therapeutic options. In contrast, efforts at the policy and system level should clearly focus on expanding access by removing cost barriers that force patients to make difficult choices (Figure). The metrics by which each of these efforts are judged must differ. Similarly, in working to increase representation in clinical trials, it is simultaneously important to emphasize the value of clinical trials, remove barriers to participation, and demonstrate trustworthiness, while also doubling down on efforts to ensure that potential participants make authentic enrollment decisions. The ethical goal of advancing equity is clear; the task of achieving and measuring it is complex. With careful attention and commitment to evidence-based approaches, however, we think that advancing health equity is attainable.

Figure. Patient, clinician, and system-level solutions for reducing inequity in guideline directed medical therapy for heart failure. SDoH indicates social determinants of health.

Disclosures Dr Rao reports prior research funding from National Institutes of Health (NIH) and AHRQ. Dr Dickert reports research funding from NIH, Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, American Heart Association (AHA), Abiomed, and Merck. Dr Dickert reports consulting fees from Abiomed. Dr Morris reports research funding from the NIH, AHA, Bristol Myers Squibb, Google, Ionis, Merck, and Novo Nordisk. Dr Morris reports consulting fees or honoraria from Abbott, BI Lilly, Cytokinetics, Merck, Novo Nordisk, and Regeneron.

For Disclosures, see page 110.

The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.

促进心力衰竭（HF）患者的健康公平是当务之急。结构性不平等和健康的社会决定因素导致了心力衰竭发病率、临床结果和治疗机会的差异。¹然而，找出研究这些不平等的最佳方法并对已确定的目标进行干预是很复杂的。由于不平等的模式是相互关联且紧密相连的，孤立地关注任何单个领域将不可避免地无法全面了解问题的范围。虽然临床实践指南阐明了针对高频谱系患者的最佳医疗和基于设备的管理，但如何将健康的社会决定因素纳入治疗算法的实施中尚不清楚。此外，试图减少一个领域的不平等可能会加剧另一领域的不平等，甚至与患者个体的价值观和偏好背道而驰，患者层面的干预措施可能与政策或系统层面的干预措施有很大不同。因此，减少心力衰竭不平等的有效策略需要了解患者的价值观并认识到不同不平等领域之间的相互作用。为了说明这些问题的伦理复杂性，我们讨论了两个公认的存在差异的背景：获得新的指南指导的药物治疗 (GDMT) 和纳入临床试验。

心力衰竭的治疗手段不断丰富，GDMT 现在涉及的治疗方法比以往任何时候都多。然而，这些疗法的处方存在差异，可能与自付费用较高的新疗法有关。²高昂的自付费用给社会经济地位较低的患者带来了不成比例的负担，他们的可支配收入较少，而且往往没有保险或保险不足。通过关注保险处方偏好或药物援助计划，可以减轻部分自付费用，并且使用多学科团队可能有助于更好地确定患者的节省机会。然而，即使在最大限度地节省成本的策略之后，GDMT 也可能根本无法负担，或者可能需要患者削减其他必要的费用来负担 GDMT，从而导致财务毒性。³出于成本考虑而制定较差的 GDMT 处方可能会使来自历史边缘群体的患者处于不成比例的不利地位。进行成本讨论以帮助患者进行这些权衡可能很复杂。帮助个体患者评估 GDMT 是否值得花费，需要了解患者的价值观、财务状况以及其他合并症背景下的心力衰竭预后。这些讨论通常受到时间、不精确的自付费用信息和健康素养的限制。此外，有效的共同决策可能会因治疗惯性或成本效益混淆等偏见而受到阻碍，而临床医生对于何时或在多大程度上推动患者纠正这些偏见的指导有限。⁴

2022 年美国心脏协会/美国心脏病学会/美国心力衰竭协会心力衰竭指南提供了 I 类建议，以针对健康的社会决定因素⁵；然而，他们没有提供关于这对个体患者水平意味着什么的建议，并且人口水平的指标可能会提供关于是否完成这项任务的误导性图片。例如，通过衡量临床医生的 GDMT 处方率或患者对 GDMT 的依从性来对抗治疗惰性，而不解决权衡或鼓励实质性成本讨论，可能会加剧财务毒性。针对临床医生的干预措施应确保患者了解医疗福利和财务影响，以便患者能够做出适合其价值观和财务状况的决定。另一方面，卫生系统或政策层面的干预措施应侧重于通过减少自付费用来提高 GDMT 的承受能力。虽然前者在当前的金融格局中至关重要，但后者对于帮助实现 GDMT 使用的公平性、减少差异和改善 HF 结果至关重要。在这方面，新型心力衰竭疗法代表了医疗保险和医疗补助服务中心通过《通货膨胀减少法案》进行价格谈判的前 10 种药物中的 3 种，这并不奇怪。⁶

心力衰竭中复杂的不平等现象也延伸到了临床研究。测试心力衰竭新疗法的临床试验正在迅速增加；然而，这些试验中妇女和少数种族和族裔群体患者代表性不足的长期问题仍然存在。未能在这些人群中充分收集数据会引起人们对研究结果的普遍性的担忧，挑战循证治疗算法的完整性，并破坏参与和信任。⁷承认代表性很重要，这在道德上是明确的。此外，最近的数据证实，照顾不同患者的临床医生更愿意开出在种族和民族代表性样本中进行测试的药物，并且不同的患者更有可能认为在代表性样本中测试过的药物对他们有效。 。⁸

目前，美国食品药品监督管理局和心血管疾病领域的主要利益相关者正在做出重大努力，以增强临床试验的多样性。⁹改善心血管试验公平性的一个关键建议指标是增加来自代表性不足的种族和族裔群体的患者的入组百分比。然而，仅仅增加临床试验中代表性不足的患者的比例并不一定能实现支撑这些努力的伦理目标。我们描述了这些问题需要更微妙的道德分析和评估的两种方式。

首先，如果忽视信任和参与的重要考虑因素，那么简单地强调增加包容性可能不足以解决这个问题的道德复杂性。特别是在当代和历史上的虐待行为的背景下，医疗保健系统已证明自己对多个少数族裔社区的成员来说是不值得信任的。对医疗保健系统的信任长期以来存在担忧。如果研究人员只是简单地针对或过度抽样拥有大量代表性不足的群体的社区，而不了解参与的障碍或采取行动来证明可信度、尊重和对参与的承诺，那么尽管错过了其他重要的道德目标，但入学人数可能会有所提高。这可能会疏远已经边缘化的群体。不信任、持续的社会经济脆弱性和获得护理机会减少等问题的根源在于结构性种族主义对边缘化社区成员的普遍影响。不承认这些更广泛的问题可能会加剧现有的紧张局势，除非有意识地努力避免可能被称为“直升机研究”的活动。

其次，增加临床试验多样性的努力可能无法认识到潜在参与者脆弱性的潜在来源。自 20 世纪 70 年代以来，人们一直非常重视保护个人免受弱势群体的侵害，例如社会经济地位较低的参与者或其他边缘化人群。人们越来越认识到，这些脆弱性的概念可能是有偏见的，而且并不总是有证据支持。¹⁰例如，关于利用激励措施加强研究招募等策略的思想发生了转变。从历史上看，为研究参与提供激励的主要担忧是它会利用或利用较贫困个体的脆弱性。新的证据表明，付款可能不会削弱同意。¹¹事实上，它可能会解决参与障碍，而且适当的付费可能有助于促进包容性和正义，而不是恶化研究中的分配正义。这需要进一步研究，但解决这一道德争议问题的正确方法应该由证据驱动。

在努力扩大对历史上代表性不足的群体的包容性时，除了激励措施之外，还有一些道德方面的考虑也至关重要。例如，这些群体成员的健康素养和对研究的总体熟悉程度可能较低。此外，过去对患者与提供者互动的研究表明，临床医生与黑人患者相处的时间较少，沟通方式也不太以患者为中心。¹²因此，增加包容性的努力必须确保同意程序经过适当设计，以促进对试验的益处和风险的理解，并且不会在来自不同种族、民族、社会经济阶层或其他人口因素的潜在参与者中以差异化方式实现这一目标。同样，个人可能会考虑参加新疗法的试验，主要是因为现有疗法过于昂贵。确保这些试验不具有剥削性至关重要。所有这些问题都很复杂，除了与正在招募的团体和社区进行真正的接触和合作以及增加试验者的多样性之外，我们在此不提出具体的解决方案。¹³我们的主要目标是强调这样一个事实：虽然增加不同人群的包容性在道德上可能是适当和重要的，但对包容性的强调不能以忽视与潜在不平等相关的其他重要道德考虑为代价。

我们强调这两个案例，因为它们体现了促进公平是复杂的、多方面的和高度情境化的方式。它们还说明，如果促进或衡量公平的方法不够细致，可能会产生意想不到的后果。就心力衰竭的 GDMT 而言，提高临床医生与患者个体接触的公平性需要与患者接触并了解他们的生活经历和价值观。成功实施以患者为中心的护理可能会适当地引导一些经济有限的患者选择较便宜的治疗方案。相比之下，政策和系统层面的努力应该明确侧重于通过消除迫使患者做出艰难选择的成本障碍来扩大可及性（图）。评判每一项努力的指标必须有所不同。同样，在努力提高临床试验的代表性时，强调临床试验的价值、消除参与障碍并证明可信度也很重要，同时还要加倍努力确保潜在参与者做出真实的入组决定。促进公平的道德目标是明确的；实现和衡量它的任务是复杂的。然而，只要认真关注并致力于循证方法，我们认为促进健康公平是可以实现的。

数字。 患者、临床医生和系统级解决方案，用于减少心力衰竭指南指导药物治疗中的不平等。SDoH 表示健康的社会决定因素。

披露Rao 博士报告了美国国立卫生研究院 (NIH) 和 AHRQ 之前的研究资助。Dickert 博士报告了来自 NIH、以患者为中心的结果研究所、医疗保健研究和质量机构、美国心脏协会 (AHA)、Abiomed 和默克公司的研究经费。Dickert 博士报告了 Abiomed 的咨询费用。Morris 博士报告了来自 NIH、AHA、Bristol Myers Squibb、Google、Ionis、Merck 和 Novo Nordisk 的研究经费。Morris 博士报告了雅培 (Abbott)、礼来 (BI Lilly)、Cytokinetics、默克 (Merck)、诺和诺德 (Novo Nordisk) 和再生元 (Regeneron) 的咨询费或酬金。

有关披露信息，请参阅第 110 页。

本文表达的观点不一定代表编辑或美国心脏协会的观点。