In July 2020, the American Cancer Society (ACS) released an updated cervical cancer screening guideline calling for primary human papillomavirus (HPV) screening as the preferred strategy.¹ Primary HPV screening refers to cervical cancer screening with an HPV test alone as the initial screening modality. Under this strategy, cervical cytology is reserved for use as one option for a triage test should the HPV test result be positive. The scientific data supporting this recommendation have been reviewed both in the United States and in other countries that have transitioned to primary HPV screening.^{2, 3}

The Primary HPV Screening Initiative (PHSI), nested under the ACS National Roundtable on Cervical Cancer, is a national consortium supported by the ACS that convenes key partners and experts on six workgroups and a Steering Committee charged with identifying critical barriers and opportunities for transitioning to primary HPV screening. The workgroups engage approximately 100 volunteers who began their activities in the fall of 2021. Workgroup members are multiprofessional and include leaders in health care policy, health care delivery, and patient care as well as patient advocates. The project is overseen by a Steering Committee (Figure 1) made up of the co-chairs of each of the six workgroups and other experts identified for their leadership in the areas of cervical cancer screening and health care policy. The final deliverable is an implementation report (roadmap), complete with tools and recommendations to support health systems, laboratories, providers, patients, and payors as they make this transition.

The Provider Needs Workgroup is developing resources in a variety of formats both to educate providers and to help them educate their patients about the benefits and safety of primary HPV screening. The deliverables include tools to aid in the management of patients with abnormal screening results. Success will be defined by change in provider behavior and will depend in large part on the degree to which major professional organizations (e.g., American College of Obstetricians and Gynecologists, American Academy of Family Physicians, Nurse Practitioners in Women's Health, and American Society for Colposcopy and Cervical Pathology) promote primary HPV screening as the standard for excellent care. The US Preventive Services Task Force recommends primary HPV screening as one of three strategies to screen for cervical cancer starting at age 30 years but does not give preference to modality.⁴ As of this writing, updated recommendations from the US Preventive Services Task Force are pending. It is desirable that all organizations agree on preferred screening guidelines to facilitate prevention efforts that are supported by evidence and widely accessible. Providers are most likely to follow guidelines promoted by their professional societies, so they are the audience of many of this workgroup's deliverables.

Currently, there appears to be limited and variable understanding among many stakeholders regarding why primary HPV screening is better than cotesting. Primary HPV screening has been shown to be more effective than screening with cytology alone and performs similarly to and with lower costs than screening with cotesting.⁵ Transitioning laboratories to support the changes needed to implement primary HPV screening in the United States is a major yet necessary undertaking. For many laboratories that do not have a US Food and Drug Administration-approved primary HPV screening platform, the logistics of changes in instrumentation, specimen workflow, implementation of newly approved tests for triage of HPV-positive cases, modification of existing quality-assurance/accreditation requirements for cytology-based testing, and impact on the cytologist workforce all need careful consideration based on size and other laboratory-specific attributes. Furthermore, quality assurance for primary HPV screening, the performance of cytology as a triage test, and that of colposcopic biopsy in vaccinated cohorts are additional challenges that affect laboratory reporting in the primary HPV screening paradigm. The Laboratory Infrastructure Workgroup has been working on developing educational and practical resources to address many of these concerns.

As many as 20% of patients in the United States are currently screened for cervical cancer using cytology alone.⁶ These patients tend to be served by safety-net providers in underserved areas and are more likely to be low-income and from communities of color.⁷ Screening with cytology alone requires more frequent testing, frequent follow-up for minor, low-risk abnormalities, and does not screen for high-risk HPV, the causative agent of virtually all cases of cervical cancer. Although it is more specific in detecting precancer, cytology is less sensitive than HPV screening, has a high number of equivocal results, and has interlaboratory variability. HPV self-sampling, once US Food and Drug Administration-approved, may be especially helpful to improve screening rates in currently underscreened populations. Therefore, changing screening practices from cytology alone to primary HPV screening is essential and may have a different set of challenges than the transition faced by programs performing cotesting, such as access and cost considerations. The Moving from Cytology Alone Workgroup is addressing the specific needs and barriers anticipated for these lower resource programs.

Information technology plays an important role in how health care providers order and manage primary HPV screening tests and how laboratories handle patient specimens and report results. The Information Technology/Electronic Health Records Needs Workgroup is identifying anticipated barriers that health systems may face and outlining recommendations to address them, recognizing that recommendations must be broad enough to apply to different electronic health record (EHR) platforms but specific enough to be useful. The importance of standardized structured data to facilitate implementation of cervical cancer screening and management clinical decision support systems into the EHR will be emphasized and explained. National Current Procedural Terminology codes and Logical Observation Identifiers Names and Codes terminology currently do not differentiate between HPV tests collected for primary HPV screening versus cotesting, which affects accurate test ordering, results tracking, and preventive care tracking tools. This issue is also being addressed by this workgroup.

In the United States, payors significantly affect which screening modalities are used in clinical practice. For a successful transition to the widespread use of primary HPV screening, the Insurance Coverage/Payors Workgroup is providing support for billing and coding for primary HPV screening. It is essential that these billing codes be available to use for patients starting at age 25 years. In addition, insurance plans across the country will need to work with their network providers to support the use of primary HPV screening. One challenge faced by this workgroup is the need to balance efforts to promote the use of primary HPV screening while ascertaining that low-resource health centers providing care to the most at-risk patients are not penalized for anticipated delays in uptake of new screening guidelines based on the costs and logistics of capital investments and implementation.

Implementation processes of previous cervical cancer screening guidelines have demonstrated that patient perception and education are important considerations when implementing new approaches. This will likely be the case for primary HPV screening and screening done using self-collected specimens in the future. The Patient Perceptions Workgroup is creating educational tools for patients that will destigmatize the role of HPV in cervical cancer screening and encourage use of the right test(s) for the right patient at the right time. Although primary HPV screening has been adopted in many countries, this workgroup will focus on issues facing women and people with a cervix in the United States that are often different than those in other countries because of cultural differences and/or different health care delivery models.

The combined efforts of these six workgroups are resulting in the creation of a catalog of resources for providers, professional societies, health systems, patients, payors, and various other stakeholders. There is intentional overlap among the workgroups and the issues that they aim to address. With the support of the Steering Committee, workgroups collaborate on issues and deliverables that are cross-cutting. We will inform partners about our work and outcomes through commentaries like this one as well as through presentations, workshops at professional society meetings, social media and email communications, website announcements, and other stakeholder forums.^{2, 8} Upon dissemination of the implementation report and tools, the members of this initiative hope to see guideline alignment and primary HPV screening being used more across the United States. This initiative will help to advance future cervical cancer areas of work, including preparing for self-sampling, and other guideline implementation opportunities.

The PHSI innovatively accelerates progress beyond guideline development and into the guideline implementation space. This initiative is a crucial step in the successful adoption of primary HPV screening and guideline alignment across organizations. In addition, the initiative is positively contributing to growing synergistic relationships and is a foundation for the newly formed ACS National Roundtable on Cervical Cancer (NRTCC).⁹ The ACS NRTCC aims accelerate progress toward cervical cancer elimination by reducing barriers to care, eliminating disparities, reducing harms, and promoting new technologies that reduce the morbidity and mortality of cervical cancer for everyone. Achieving the Initiative's objectives and harnessing the power of these collaborative relationships over the next year will provide a critical and model infrastructure to support advancements in cervical cancer prevention and elimination in the coming years through the ACS NRTCC and other channels.

To learn more and give comment or input to our efforts, you can visit our website (cervicalroundtable.org).

2020年7月，美国癌症协会（ACS）发布了更新的宫颈癌筛查指南，呼吁将初次人乳头瘤病毒（HPV）筛查作为首选策略。¹ 初次 HPV 筛查是指仅以 HPV 检测作为初始筛查方式的宫颈癌筛查。根据这一策略，如果 HPV 检测结果呈阳性，则保留宫颈细胞学检查作为分类检测的一种选择。支持这一建议的科学数据已在美国和其他已过渡到初级 HPV 筛查的国家进行了审查。^{2, 3}

初级 HPV 筛查计划 (PHSI) 隶属于 ACS 国家宫颈癌圆桌会议，是一个由 ACS 支持的国家联盟，它召集了六个工作组​​的主要合作伙伴和专家以及一个指导委员会，负责确定过渡到宫颈癌的关键障碍和机会。初级 HPV 筛查。该工作组约有 100 名志愿者，他们于 2021 年秋季开始开展活动。工作组成员来自多个专业领域，包括医疗保健政策、医疗保健提供和患者护理领域的领导者以及患者倡导者。该项目由指导委员会（图 1）监督，该委员会由六个工作组​​的联合主席和在宫颈癌筛查和医疗保健政策领域具有领导地位的其他专家组成。最终的交付成果是一份实施报告（路线图），其中包含支持卫生系统、实验室、提供者、患者和付款人进行这一转变的工具和建议。

提供者需求工作组正在开发各种形式的资源，以教育提供者并帮助他们教育患者了解初级 HPV 筛查的益处和安全性。可交付成果包括帮助管理筛查结果异常患者的工具。成功将由提供者行为的改变来定义，并且在很大程度上取决于主要专业组织（例如美国妇产科医师学会、美国家庭医师学会、妇女健康护士执业者协会和美国阴道镜协会）的程度和宫颈病理学）提倡将初级 HPV 筛查作为优质护理的标准。美国预防服务工作组建议将初级 HPV 筛查作为从 30 岁开始筛查宫颈癌的三种策略之一，但并不优先考虑筛查方式。⁴截至撰写本文时，美国预防服务工作组的更新建议仍在等待中。希望所有组织就首选筛查指南达成一致，以促进有证据支持且可广泛获取的预防工作。提供者最有可能遵循其专业协会推广的指导方针，因此他们是该工作组许多交付成果的受众。

目前，许多利益相关者对于为什么初级 HPV 筛查比联合检测更好的理解似乎有限且存在差异。初级 HPV 筛查已被证明比单独使用细胞学筛查更有效，并且与联合检测筛查的效果相似且成本更低。⁵实验室转型以支持在美国实施初级 HPV 筛查所需的变革是一项重大但必要的任务。对于许多没有美国食品和药物管理局批准的初级 HPV 筛查平台的实验室来说，仪器变更的后勤工作、样本工作流程、实施新批准的 HPV 阳性病例分类测试、修改现有的质量保证/基于细胞学的检测的认证要求以及对细胞学家队伍的影响都需要根据规模和其他实验室特定属性进行仔细考虑。此外，初级 HPV 筛查的质量保证、细胞学作为分类测试的性能以及疫苗接种群体中阴道镜活检的性能是影响初级 HPV 筛查范式中实验室报告的其他挑战。实验室基础设施工作组一直致力于开发教育和实践资源，以解决其中的许多问题。

目前，美国有多达 20% 的患者仅使用细胞学筛查宫颈癌。⁶这些患者往往由服务不足地区的安全网提供者提供服务，并且更有可能是低收入者和有色人种社区。⁷仅用细胞学筛查需要更频繁的检测，对轻微的低风险异常进行频繁的随访，并且不能筛查高危 HPV，而高危 HPV 是几乎所有宫颈癌病例的病原体。尽管细胞学检测在检测癌前病变方面更具特异性，但其敏感性不如 HPV 筛查，且结果存在大量模棱两可的情况，并且存在实验室间差异。HPV 自我采样一旦获得美国食品和药物管理局批准，可能特别有助于提高目前筛查不足人群的筛查率。因此，将筛查做法从单独的细胞学筛查改为初级 HPV 筛查至关重要，并且可能会面临与进行联合检测的项目所面临的转变不同的挑战，例如获取和成本考虑。不再单独进行细胞学工作组正在解决这些资源较低的项目预期的具体需求和障碍。

信息技术在医疗保健提供者如何订购和管理初级 HPV 筛查测试以及实验室如何处理患者标本和报告结果方面发挥着重要作用。信息技术/电子健康记录需求工作组正在确定卫生系统可能面临的预期障碍，并概述解决这些障碍的建议，认识到建议必须足够广泛以适用于不同的电子健康记录 (EHR) 平台，但又必须足够具体以发挥作用。将强调和解释标准化结构化数据对于促进在 EHR 中实施宫颈癌筛查和管理临床决策支持系统的重要性。国家现行程序术语代码和逻辑观察标识符名称和代码术语目前不区分为初级 HPV 筛查和联合检测而收集的 HPV 检测，这会影响准确的检测顺序、结果跟踪和预防性护理跟踪工具。该工作组也在解决这个问题。

在美国，付款人显着影响临床实践中使用的筛查方式。为了成功过渡到广泛使用初级 HPV 筛查，保险范围/付款人工作组正在为初级 HPV 筛查的计费和编码提供支持。这些账单代码必须可供 25 岁以上的患者使用。此外，全国各地的保险计划需要与其网络提供商合作，支持初级 HPV 筛查的使用。该工作组面临的一个挑战是需要平衡努力，以促进初级 HPV 筛查的使用，同时确定为高危患者提供护理的资源匮乏的卫生中心不会因采用新筛查指南的预期延迟而受到惩罚。关于资本投资和实施的成本和物流。

先前宫颈癌筛查指南的实施过程表明，患者的认知和教育是实施新方法时的重要考虑因素。未来初级 HPV 筛查和使用自行采集样本进行的筛查很可能就是这种情况。患者认知工作组正在为患者创建教育工具，以消除 HPV 在宫颈癌筛查中的作用，并鼓励在正确的时间为正确的患者使用正确的检测。尽管许多国家已采用初级 HPV 筛查，但该工作组将重点关注美国妇女和宫颈癌患者面临的问题，这些问题通常因文化差异和/或不同的医疗保健提供模式而与其他国家不同。

这六个工作组​​的共同努力正在为提供者、专业协会、卫生系统、患者、支付者和各种其他利益相关者创建资源目录。工作组及其旨在解决的问题之间故意存在重叠。在指导委员会的支持下，工作组就跨领域的问题和可交付成果进行协作。我们将通过此类评论以及专业协会会议上的演示、研讨会、社交媒体和电子邮件通信、网站公告和其他利益相关者论坛，向合作伙伴通报我们的工作和成果。^{2, 8}在传播实施报告和工具后，该倡议的成员希望看到指南调整和初级 HPV 筛查在美国得到更多使用。该举措将有助于推进未来宫颈癌领域的工作，包括准备自我采样和其他指南实施机会。

PHSI 创新性地加速了指南制定和指南实施领域的进展。这一举措是跨组织成功采用初级 HPV 筛查和指南一致性的关键一步。此外，该倡议还积极促进了协同关系的发展，并为新成立的 ACS 国家宫颈癌圆桌会议 (NRTCC) 奠定了基础。⁹ ACS NRTCC 旨在通过减少护理障碍、消除差异、减少伤害以及推广新技术来降低每个人的宫颈癌发病率和死亡率，从而加速消除宫颈癌的进展。明年实现该倡议的目标并利用这些合作关系的力量将提供关键的模型基础设施，以支持未来几年通过 ACS NRTCC 和其他渠道在宫颈癌预防和消除方面取得进展。

要了解更多信息并对我们的工作发表评论或意见，您可以访问我们的网站 (cervicalroundtable.org)。