GeNYC: Genomic Implementation Research in the Diverse Settings and Populations of New York City
GeNYC:纽约市不同环境和人群的基因组实施研究
基本信息
- 批准号:10222745
- 负责人:
- 金额:$ 55.91万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-09-18 至 2023-06-30
- 项目状态:已结题
- 来源:
- 关键词:APOL1 geneAddressAdultAdvocateAffectAfricanAttentionBlood PressureCaringChronic DiseaseChronic Kidney FailureClinicClinical TrialsCommunitiesConduct Clinical TrialsDiabetes MellitusDiagnosisDisciplineDisease ManagementEducational MaterialsElectronic Health RecordEquipoiseEthicsFutureGenetic RiskGenomic medicineGenomicsGenotypeHealthHealth PolicyHealth systemHealthcareHeartHypertensionInterventionKidneyKidney DiseasesKidney FailureLatinoLow incomeMedicalMedicineNew York CityParticipantPatient-Focused OutcomesPatientsPharmaceutical PreparationsPhenotypePlant RootsPopulationPopulation HeterogeneityPositioning AttributePragmatic clinical trialPrimary Health CareProviderRandomizedResearchResearch PersonnelRiskScienceShapesSiteTest ResultTestingTrainingTranslational ResearchUnderrepresented PopulationsVariantVulnerable PopulationsWaiting ListsWorkbehavioral outcomecare providersclinical careclinical decision supportclinical practicecost effectivenessdisease disparitydisorder controldisorder preventionexperiencefollow-upgenetic counselorgenetic testinghealth disparityhealth equityhigh riskimplementation researchimplementation scienceimprovedinnovationliteracymeetingspatient subsetspoint of careprimary outcomeracial and ethnicrandomized trialrecruitretention raterisk variantsafety netsecondary outcomesupport tools
项目摘要
The promise of genomic medicine implementation transforming healthcare and improving health will not be
realized until discoveries become relevant to and available for use by diverse populations and the clinicians
who care for them. Our GeNYC team is prepared to help medical genomics become an innovative,
collaborative discipline with inclusiveness, health and health equity at its core. We have decades of experience
engaging diverse stakeholders- researchers, patients, clinicians, advocates and entrepreneurs- to conduct
chronic disease prevention and control clinical trials in our large health system and network of safety net
clinics. In our 16 trials recently
mean
completed or underway, 80% included primary care or community sites, with a
732 participants/study, 69% were African ancestry (AA) or Latino, 17% refused, and we retained 84%.
We chose toharness this expertise to conduct genomic implementation research. At the heart of our team
is a Genomics Stakeholder Board. Together, we conducted GUARDD, a multi-site pragmatic clinical trial (PCT)
to study effects and challenges of incorporating genetic risk information into primary care. We tested AA adults
with hypertension, without diabetes or chronic kidney disease (CKD) for APOL1 high-risk variants nearly
exclusive to AAs, that increase kidney failure risk 10-fold. We recruited 2052 AA adults from 15 community and
academic primary care practices in NYC, trained lay staff who returned APOL1 results to patients and alerted
clinicians of results through clinical decision support in electronic health records (EHRs). Our co-primary
outcome, systolic blood pressure (SBP) at 3m (retention rate 93%) reduced by 6mmHg in those told they had
high-risk APOL1 genotypes vs. 3mmHg if told they were low-risk (p=0.008).
We are now prepared and committed to join IGNITE II and conduct genomic implementation PCTs in
diverse settings and populations. We brought a transdisciplinary team together for this purpose, and to study
the impact of APO1 risk information on a broader phenotype of AA patients, including those with CKD, who
have even higher risk for kidney failure and are often undiagnosed by primary care providers. We aim to: (1)
Serve as an enhanced diversity site for IGNITE2, facilitating recruitment and retention of patients into genomic
implementation PCTs; and (2) Conduct GUARDD-US, a network-wide PCT expanding GUARDD to AA
patients without and with CKD and to other IGNITE sites with different patient and provider populations. We will
randomize patients to APOL1 testing vs. waitlist control, and evaluate impact on SBP, renal diagnosis, cost
effectiveness and psycho-behavioral outcomes, so results can inform decisions by clinicians, policymakers and
payers. If successful, GeNYC may provide a robust framework for future endeavors to implement genomic
medicine in diverse clinical practices, validate APOL1 risk-informed management of hypertensive AA patients
at high risk of kidney failure, contribute to important efforts to eliminate racial, ethnic and ancestral disparities in
health, and show that vulnerable populations can be the first to benefit from genomic discoveries.
基因组医学实施改变医疗保健和改善健康的承诺不会兑现
直到发现与不同人群和临床医生相关并可供使用
谁关心他们。我们的 GeNYC 团队已准备好帮助医学基因组学成为一种创新的、
以包容性、健康和健康公平为核心的合作纪律。我们拥有数十年的经验
让不同的利益相关者——研究人员、患者、临床医生、倡导者和企业家——参与
我们庞大的卫生系统和安全网网络中的慢性病预防和控制临床试验
诊所。在我们最近的 16 次试验中
意思是
已完成或正在进行中,80% 包括初级保健或社区场所,
每项研究有 732 名参与者,其中 69% 是非洲血统 (AA) 或拉丁裔,17% 拒绝,我们保留了 84%。
我们选择利用这些专业知识来进行基因组实施研究。我们团队的核心
是一个基因组学利益相关者委员会。我们共同开展了 GUARDD,一项多中心实用临床试验 (PCT)
研究将遗传风险信息纳入初级保健的影响和挑战。我们测试了 AA 成人
患有高血压、无糖尿病或慢性肾病 (CKD) 的 APOL1 高风险变异几乎
AA 独有,可使肾衰竭风险增加 10 倍。我们从 15 个社区招募了 2052 名 AA 成年人,
纽约市的学术初级保健实践,训练有素的非专业工作人员将 APOL1 结果返回给患者并发出警报
临床医生通过电子健康记录 (EHR) 中的临床决策支持来了解结果。我们的共同小学
结果,那些被告知患有高血压的患者在 3m 处的收缩压 (SBP)(保留率 93%)降低了 6mmHg
高风险 APOL1 基因型与 3mmHg(如果被告知其为低风险)(p=0.008)。
我们现在准备并致力于加入 IGNITE II 并在以下国家开展基因组实施 PCT:
不同的环境和人群。为此,我们组建了一个跨学科团队,并研究
APO1 风险信息对更广泛的 AA 患者表型的影响,包括 CKD 患者,
肾衰竭的风险更高,并且常常未被初级保健提供者诊断。我们的目标是:(1)
作为 IGNITE2 的增强多样性位点,促进患者招募和保留到基因组中
实施PCT; (2) 实施 GUARDD-US,这是一项将 GUARDD 扩展到 AA 的全网络 PCT
患有和患有 CKD 的患者以及具有不同患者和提供者群体的其他 IGNITE 站点。我们将
将患者随机分配进行 APOL1 检测与候补对照,并评估对 SBP、肾脏诊断、成本的影响
有效性和心理行为结果,因此结果可以为临床医生、政策制定者和决策者提供决策依据
付款人。如果成功,GeNYC 可能会为未来实施基因组学的努力提供一个强大的框架
医学在不同的临床实践中验证 APOL1 对高血压 AA 患者的风险告知管理
肾衰竭的高风险,为消除种族、民族和祖先差异做出重要贡献
健康,并表明弱势群体可以首先从基因组发现中受益。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Carol R Horowitz其他文献
Cross-sectional analysis of factors associated with medication adherence in western Kenya
肯尼亚西部药物依从性相关因素的横断面分析
- DOI:
- 发表时间:
2023 - 期刊:
- 影响因子:2.9
- 作者:
Pooja Gala;J. Kamano;Manuel Vazquez Sanchez;Richard Mugo;Vitalis Orango;S. Pastakia;Carol R Horowitz;Joseph W Hogan;Rajesh Vedanthan - 通讯作者:
Rajesh Vedanthan
Vaccine Effectiveness Against Long COVID in Children: A Report from the RECOVER EHR Cohort
疫苗对儿童长期新冠病毒的有效性:来自 RECOVER EHR 队列的报告
- DOI:
- 发表时间:
2023 - 期刊:
- 影响因子:0
- 作者:
H. Razzaghi;Christopher B Forrest;Kathryn Hirabayshi;Qiong Wu;Andrea J Allen;Suchitra Rao;Yong Chen;Timothy Bunnell;Elizabeth A. Chrischilles;Lindsey G Cowell;Mollie R. Cummins;D. Hanauer;Miranda Higginbotham;Benjamine Horne;Carol R Horowitz;Rhavi Jhaveri;Susan Kim;A. Mishkin;Jennifer Muszynski;Susanna Naggie;N. Pajor;Anuradha Paranjape;Hayden T. Schwenk;M. Sills;Y. Tedla;David A Williams;Charles Bailey - 通讯作者:
Charles Bailey
Trends and disparities in prevalence of cardiometabolic diseases by food security status in the United States
美国粮食安全状况下心脏代谢疾病患病率的趋势和差异
- DOI:
- 发表时间:
2024 - 期刊:
- 影响因子:0
- 作者:
Junxiu Liu;Stella S. Yi;Rienna G. Russo;Carol R Horowitz;Donglan Zhang;Janani Rajbhandari;Dejun Su;Lu Shi;Yan Li - 通讯作者:
Yan Li
Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
研究新冠肺炎以促进康复 (RECOVER) 儿科研究方案:基本原理、目标和设计
- DOI:
- 发表时间:
2024 - 期刊:
- 影响因子:3.7
- 作者:
R. Gross;Tanayott Thaweethai;E. Rosenzweig;James Chan;Lori B Chibnik;Mine S Cicek;Amy J. Elliott;Valerie J Flaherman;Andrea S. Foulkes;Margot Gage Witvliet;Richard Gallagher;M. L. Gennaro;Terry L Jernigan;Elizabeth W Karlson;Stuart D. Katz;P. Kinser;Lawrence Kleinman;M. Lamendola;Joshua D Milner;S. Mohandas;Praveen C. Mudumbi;Jane W. Newburger;Kyung E Rhee;Amy L Salisbury;Jessica Snowden;Cheryl R Stein;Melissa S Stockwell;K. Tantisira;M. Thomason;D. Truong;David Warburton;John C Wood;Shifa Ahmed;Almary Akerlundh;Akram N. Alshawabkeh;Brett R Anderson;J. Aschner;A. Atz;Robin L. Aupperle;F. C. Baker;V. Balaraman;D. Banerjee;Deanna M Barch;A. Baskin;S. Bhuiyan;Marie;A. Bogie;Tamara T Bradford;Natalie C Buchbinder;Elliott Bueler;H. Bükülmez;B. J. Casey;Linda Chang;M. Chrisant;Duncan B. Clark;R. Clifton;K. Clouser;Lesley Cottrell;Kelly Cowan;V. D’Sa;M. Dapretto;Soham Dasgupta;W. Dehority;Audrey Dionne;Kirsten B Dummer;Matthew D. Elias;Shari Esquenazi;Danielle N Evans;E. V. S. Faustino;Alexander G Fiks;Daniel E Forsha;John J Foxe;Naomi P. Friedman;G. Fry;Sunanda Gaur;Dylan G. Gee;Kevin M Gray;Stephanie Handler;Ashraf S Harahsheh;Keren Hasbani;Andrew C Heath;Camden L Hebson;M. Heitzeg;Christina M. Hester;Sophia Hill;Laura Hobart;T. Hong;Carol R Horowitz;Daniel S. Hsia;M. Huentelman;Kathy D Hummel;Katherine Irby;Jan Jacobus;Vanessa L Jacoby;P. Jone;D. C. Kaelber;Tyler J Kasmarcak;Matthew J Kluko;Jessica S Kosut;Angela R. Laird;J. Landeo;Sean M. Lang;Christine L Larson;P. P. C. Lim;K. Lisdahl;B. McCrindle;Russell J. McCulloh;Kimberly McHugh;A. Mendelsohn;Torri D. Metz;Julie Miller;Elizabeth C Mitchell;Lerraughn M. Morgan;E. Müller;E. Nahin;M. Neale;Manette Ness;Sheila M Nolan;Carlos R Oliveira;Onyekachukwu Osakwe;Matthew E Oster;R. M. Payne;Michael A Portman;H. Raissy;Isabelle G Randall;Suchitra Rao;Harrison T. Reeder;Johana M. Rosas;Mark W. Russell;Arash A. Sabati;Yamuna Sanil;Alice I Sato;Michael S. Schechter;R. Selvarangan;S. S. Sexson Tejtel;Divya Shakti;Kavita Sharma;Lindsay M. Squeglia;Shubika Srivastava;M. Stevenson;J. Szmuszkovicz;Maria M. Talavera;R. Teufel;Deepika Thacker;Felicia L Trachtenberg;Mmekom M Udosen;Megan R Warner;Sara E. Watson;A. Werzberger;Jordan C Weyer;Marion J Wood;H. S. Yin;William Zempsky;Emily Zimmerman;B. Dreyer - 通讯作者:
B. Dreyer
Sociodemographic and Behavioral Factors Associated With Hypertension and Depression in 4 Rural Communities in Northern Ghana: A Cross-Sectional Study
加纳北部 4 个农村社区与高血压和抑郁症相关的社会人口和行为因素:一项横断面研究
- DOI:
10.1177/21501319241242965 - 发表时间:
2024-01-01 - 期刊:
- 影响因子:0
- 作者:
Masih A. Babagoli;Dorothy Adu;E. Nonterah;R. Aborigo;I. Kuwolamo;Khadija R Jones;Evan E Alvarez;Carol R Horowitz;Benedict Weobong;David J Heller - 通讯作者:
David J Heller
Carol R Horowitz的其他文献
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{{ truncateString('Carol R Horowitz', 18)}}的其他基金
GeNYC: Genomic Implementation Research in the Diverse Settings and Populations of New York City
GeNYC:纽约市不同环境和人群的基因组实施研究
- 批准号:
10822886 - 财政年份:2023
- 资助金额:
$ 55.91万 - 项目类别:
Genetic testing to Address Renal Disease Disparities Across the U.S. (GUARDD-US) - Administrative Supplement
通过基因检测解决全美肾脏疾病差异问题 (GUARDD-US) - 行政补充
- 批准号:
10620537 - 财政年份:2022
- 资助金额:
$ 55.91万 - 项目类别:
GeNYC: Genomic Implementation Research in the Diverse Settings and Populations of New York City
GeNYC:纽约市不同环境和人群的基因组实施研究
- 批准号:
9892150 - 财政年份:2018
- 资助金额:
$ 55.91万 - 项目类别:
GeNYC: Genomic Implementation Research in the Diverse Settings and Populations of New York City
GeNYC:纽约市不同环境和人群的基因组实施研究
- 批准号:
9982391 - 财政年份:2018
- 资助金额:
$ 55.91万 - 项目类别:
GeNYC: Genomic Implementation Research in the Diverse Settings and Populations of New York City
GeNYC:纽约市不同环境和人群的基因组实施研究
- 批准号:
10456789 - 财政年份:2018
- 资助金额:
$ 55.91万 - 项目类别:
Genomic Medicine Pilot For Hypertension And Kidney Disease In Primary Care
初级保健中高血压和肾脏疾病的基因组医学试点
- 批准号:
9266157 - 财政年份:2016
- 资助金额:
$ 55.91万 - 项目类别:
Genomic Medicine Pilot For Hypertension And Kidney Disease In Primary Care
初级保健中高血压和肾脏疾病的基因组医学试点
- 批准号:
9402857 - 财政年份:2013
- 资助金额:
$ 55.91万 - 项目类别:
Genomic Medicine Pilot For Hypertension And Kidney Disease In Primary Care
初级保健中高血压和肾脏疾病的基因组医学试点
- 批准号:
9091594 - 财政年份:2013
- 资助金额:
$ 55.91万 - 项目类别:
Genomic Medicine Pilot For Hypertension And Kidney Disease In Primary Care
初级保健中高血压和肾脏疾病的基因组医学试点
- 批准号:
8843915 - 财政年份:2013
- 资助金额:
$ 55.91万 - 项目类别:
PRAISE: Preventing recurrence of all inner-city strokes through education;
赞扬:通过教育预防所有市中心中风的复发;
- 批准号:
8263003 - 财政年份:2011
- 资助金额:
$ 55.91万 - 项目类别:
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