Patient- and Practice-Centered Assessment of Self-Collection

以患者和实践为中心的自取评估

基本信息

批准号：
8729296
负责人：
Andrew Louis Sussman
金额：
$ 29.77万
依托单位：
UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/8729296
关键词：
Address American Indians Appalachian Region Caring Cervical Cervical Cancer Screening Clinic Clinical Clinical Sensitivity Collection Communities Community Practice Complex Continuity of Patient Care Counseling Country Cytology DNA Decision Making Development Disease Documentation Effectiveness Evaluation Failure Hispanics Home environment Human Papillomavirus Income Intervention Intervention Trial Interview Life Link Malignant Neoplasms Malignant neoplasm of cervix uteri Methods Mexico Mississippi New Mexico Outcome Outcome Measure Patient Care Patients Performance Phase Population Poverty Prevention program Primary Health Care Process Provider Resources Sample Size Sampling Self Assessment Specimen Test Result Testing Translational Research Underserved Population Woman Work aged base cancer care cervical cancer prevention cervicovaginal design experience innovation medically underserved novel strategies patient population primary care setting programs screening translational study willingness

项目摘要

Failures to screen women for cervical cancer are well documented. The current U.S. screening program fails to reach small pockets of populations living mainly in low-resource, medically underserved regions as part of a complex of diseases linked to poverty and/or racial disparities. These populations have cen/ical cancer rates that are similar to middle-income countries and contribute approximately 60% of the cervical cancer cases that occur annually in the U.S. it is reasonable to suggest that the current cervical cancer prevention program has reached its limits and innovative strategies are needed to overcome these barriers and further reduce the burden in underserved populations. HPV DNA testing offers a promising strategy to enhance cervical screening coverage and address both patient and primary care provider challenges along the care process. HPV DNA testing is highly sensitive (90-95%) for identifying women with cervical precancer and cancer when using a clinician-collected specimen, and 20-50% more sensitive than routine cytology programs. Thus, self-collection combined with HPV DNA testing can potentially be used to extend access to women who are not reached by current Pap-based programs. However, there are only limited, small studies of self-collection in the U.S. and more work is needed to determine whether self-collection is acceptable to diverse patient populations as well as potential barriers toward integration of this approach into primary care settings. This mixed method study is designed to: 1. fully describe the current cervical cancer screening and treatment care continuum, and to assess the translational potential of a promising new approach - self-collection - by conducting a three-phase sequential mixed-method translational study (Phase la): 2. involve American Indian and Hispanic women in the co-development of a culturally-appropriate approach to self-collection (Phase lb): 3. integrate practice assessment and patient findings (Aims 1 and 2) in an intervention to assess the feasibility and comparability of self-collection methods for HPV testing and routine cervical cytology with HPV co-testing in four purposefully selected primary care clinical settings: (Phase 2)

未能对女性进行宫颈癌筛查的情况已有充分记录。美国目前的筛查计划未能惠及主要生活在资源匮乏、医疗服务不足地区的一小部分人口，因为与贫困和/或种族差异有关的一系列疾病的一部分。这些人群有疾病癌症发病率与中等收入国家相似，约占宫颈癌的 60% 根据美国每年发生的癌症病例，有理由认为目前的宫颈癌预防计划已达到其极限，需要创新战略来克服这些问题障碍并进一步减轻服务不足人群的负担。 HPV DNA 检测提供了一个有前途的方法提高宫颈筛查覆盖率并解决患者和初级保健提供者问题的策略护理过程中的挑战。 HPV DNA 检测对于识别女性具有高度敏感性 (90-95%) 使用临床医生采集的样本时，可发现宫颈癌前病变和癌症，敏感性提高 20-50% 比常规细胞学程序。因此，自我收集与 HPV DNA 检测相结合可能会用于扩大目前基于宫颈抹片计划未覆盖的女性的使用范围。然而，有仅对美国的自我收集进行了有限的小型研究，需要做更多的工作来确定是否自助收集对于不同的患者群体来说是可以接受的，但也存在融合的潜在障碍将这种方法引入初级保健机构。这项混合方法研究旨在： 1. 全面描述当前宫颈癌筛查和治疗护理的连续性，并评估通过进行三个阶段，自我收集这一有前途的新方法的转化潜力序贯混合方法转化研究（la 期）： 2. 让美洲印第安人和西班牙裔妇女参与共同开发适合文化的项目自行收集的方法（第 lb 阶段）： 3. 将实践评估和患者发现（目标 1 和 2）整合到干预措施中，以评估 HPV检测和常规宫颈细胞学检查的自我收集方法的可行性和可比性在四个特意选择的初级保健临床环境中进行 HPV 联合检测：（第 2 阶段）