NIA AD/ADRD Health Care Systems Research Collaboratory

NIA AD/ADRD 医疗保健系统研究合作实验室

• 批准号: 10308958
• 负责人: SUSAN L MITCHELL
• 金额: $ 122.33万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10308958
• 关键词: 2019-nCoV; Address; Adverse effects; Adverse event; Affect; Alzheimer' s disease diagnosis; Alzheimer' s disease related dementia; Behavioral; COVID-19; COVID-19 diagnosis; COVID-19 mortality; COVID-19 pandemic; COVID-19 vaccination; COVID-19 vaccine; Caregivers; Cessation of life; Characteristics; Clinical; Country; Data; Databases; Dementia; Dependence; Development; Diagnosis; Disabled Persons; Disease; Dose; Elderly; Enrollment; Ensure; Ethnic Origin; Ethnic group; Frail Elderly; General Population; Health; Healthcare Systems; Immune system; Individual; Influenza vaccination; Information Systems; Investments; Manufacturer Name; Medical; Medicare; Medicare claim; Minority; Monitor; Morbidity - disease rate; Neurodegenerative Disorders; Neurologic; Nursing Homes; Patients; Pharmacy facility; Phase; Population; Population Distributions; Race; Randomized Clinical Trials; Records; Reporting; Risk; Safety; Site; Societies; Stroke; Subgroup; System; Testing; Time; Transportation; Uncertainty; Update; Vaccinated; Vaccination; Vaccine Clinical Trial; Vaccines; Virus; adverse event risk; base; beneficiary; collaboratory; comorbidity; coronavirus disease; demented; design; ethnic minority population; high risk population; logarithm; middle age; mortality; news; pandemic disease; population based; racial and ethnic; response; seasonal influenza; senescence; success; systems research; vaccine access; vaccine adverse event; vaccine effectiveness; vaccine efficacy; vaccine hesitancy; vaccine safety; vaccine trial; volunteer; young adult

ABSTRACT The SARS-CoV-2 pandemic has had a devastating impact upon the US population with over 12 million positive cases and some 260,000 deaths as of mid-November, 2020. In no population has the impact of this virus been more apparent than in the elderly population and those with significant medical co-morbidities. All population-based analyses conducted to date suggest that the risk of morbidity and mortality in the elderly population, relative to younger adults, increases logarithmically. Indeed, even controlling for extensive clinical characteristics in a nursing home population, advanced age has a substantial influence on COVID-19 mortality. Furthermore, a diagnosis of Alzheimer’s Disease and Related Dementias (ADRD) appear to confer excess risk of morbidity and mortality associated with COVID-19, whether in a nursing home or not. The world- wide scientific and medical enterprise has responded to the pandemic by investment in the development of numerous vaccines. Recent extremely positive preliminary results from several manufacturers indicates that vaccines will be distributed by early 2021. However, since elderly and disabled Medicare beneficiaries were under-represented in the volunteers included in randomized clinical trials, it is possible that the senescent immune system might increase their risk of vaccine-related adverse effects from the vaccine or fail to protect them as much as are younger people. Given that those with ADRD already suffer from a neurodegenerative disease, they may be at greater risk of well-established, serious neurological adverse events of vaccines such as stroke and Guillain-Barre Disease. In addition, the unknown potential for adverse events may result in high rates of incomplete vaccination among frail older adults vulnerable to SARS-CoV-2. Unsuccessful vaccination might be further exacerbated among older adults with ADRD by barriers to vaccination, such as dependence on a caregiver for transportation. Given that the success of national SARS- CoV-2 vaccination efforts depends on both vaccine efficacy and vaccine coverage, ensuring that dementia patients and those with co-morbidities receive all required doses is critical. Since society cannot wait to vaccinate this population with an effective vaccine, we must establish an active post-vaccination surveillance system of a large population to report vaccine safety Working closely with CVS, the largest pharmacy company in the country which has been designated as a major site for distribution of the SARS-CoV-2 vaccine(s), we propose to match the background and pharmacy records of some 13 million customers who are Medicare beneficiaries to Medicare data maintained by Acumen, LLC in order to build a merged CVS and Medicare claims data system, examine demographic, race/ethnicity, clinical (e.g., ADRD), and health care system factors associated with being vaccinated, estimate the rate of adverse events attributable to the vaccine and estimate breakthrough COVID illness among vaccinated Medicare beneficiaries.

摘要 SARS-CoV-2大流行对美国人口造成了毁灭性的影响， 截至2020年11月中旬，约有26万例阳性病例和死亡病例。在任何人群中， 病毒感染比老年人群和有显著医学共病的人群更明显。所有 迄今为止进行的基于人口的分析表明，老年人的发病率和死亡率风险 相对于年轻的成年人来说，人口呈几何增长。事实上，即使控制了广泛的临床 养老院人群的特征，高龄对COVID-19有重大影响 mortality.此外，阿尔茨海默氏病和相关痴呆症（ADRD）的诊断似乎赋予 与COVID-19相关的发病率和死亡率的过度风险，无论是否在养老院。 这家全球性的科学和医疗企业通过投资于 开发了多种疫苗。几家制造商最近的初步结果非常积极 疫苗将于2021年初分发。然而，由于老年人和残疾人医疗保险 受益人在随机临床试验纳入的志愿者中代表性不足， 衰老的免疫系统可能会增加疫苗相关不良反应的风险， 不能像年轻人那样保护他们。考虑到ADRD患者已经患有 神经退行性疾病，他们可能有更大的风险，明确的，严重的神经系统不良反应 疫苗接种后，如中风和格林-巴利病。此外，未知的潜在不良反应 这些事件可能导致易感染SARS-CoV-2的体弱老年人的高疫苗接种不完全率。 不成功的疫苗接种可能会在患有ADRD的老年人中进一步加剧， 接种疫苗，如依赖照顾者运输。鉴于全国SARS的成功- CoV-2疫苗接种工作取决于疫苗有效性和疫苗覆盖率，确保痴呆症 患者和合并症患者接受所有所需剂量至关重要。 由于社会不能等待为这一人群接种有效的疫苗，我们必须建立一个积极的 大规模人群疫苗接种后监测系统，报告疫苗安全性与CVS密切合作， 该公司是该国最大的制药公司，已被指定为分发 SARS-CoV-2疫苗，我们建议匹配大约1300万人的背景和药房记录， 作为Medicare受益人的客户访问Acumen，LLC维护的Medicare数据，以建立 合并的CVS和医疗保险索赔数据系统，检查人口统计学，种族/民族，临床（例如，ADRD）， 以及与接种疫苗相关的卫生保健系统因素， 并估计接种疫苗的医疗保险受益人中的突破性COVID疾病。