Update on RFA Increasing Use of Cardiac and Pulmonary Rehabilitation in Traditional and Community Settings NIH-Funded Trials: ADDRESSING CLINICAL TRIAL CHALLENGES PRESENTED BY THE COVID-19 PANDEMIC.
Update on RFA Increasing Use of Cardiac and Pulmonary Rehabilitation in Traditional and Community Settings NIH-Funded Trials: ADDRESSING CLINICAL TRIAL CHALLENGES PRESENTED BY THE COVID-19 PANDEMIC.
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关于 RFA 在传统和社区环境中增加 NIH 资助试验中心肺康复的使用的最新信息：解决 COVID-19 大流行带来的临床试验挑战。
DOI：
10.1097/hcr.0000000000000635
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发表时间：
2022
影响因子：
3.8
通讯作者：
Fleg,JeromeL
中科院分区：
文献类型：
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作者：
Shero,SusanT;Benzo,Roberto;Cooper,LawtonS;Finkelstein,Joseph;Forman,DanielE;Gaalema,DiannE;Joseph,Lyndon;Keteyian,StevenJ;Peterson,PamelaN;Punturieri,Antonello;Zieman,Susan;Fleg,JeromeL
12心脏病康复和预防杂志2022; 42：10-14 www. jcrpjournal。com完成的CR疗程显著多于随机分配至单独临床CR的患者。次要目的是评估HYCR对运动能力和生活质量的影响。2020年3月中旬，亨利福特医院暂停所有门诊临床和研究活动。这项政策影响了26名积极参与标准CR（S-CR）或混合CR（使用视频同步远程医疗的诊所和家庭联合治疗）试验组的患者。无论研究组分配如何，对于这26例患者，将CR手术暂停时参加的CR治疗次数作为其完成试验的治疗次数（表）。与COVID-19相关的暂停直接影响了主要试验终点的评估，数据和安全监测委员会（DSMB）正在评估如何将这26名患者的数据纳入统计分析。例如，一项主要终点受COVID-19影响的试验从其主要分析中排除了所有受影响的参与者相关数据，但在次要分析中纳入了此类数据。6于2020年6月，新患者招募恢复使用COVID-19特定程序（例如，CR期间戴口罩，个人vs团体教育）。由于COVID-19，iATTEND的发现越来越重要，因为该试验评估了在设施外提供CR。7此外，由于COVID-19，卫生系统现在通过在其服务中增加基于远程医疗的HYCR计划，为协助CR计划做好了更好的准备。为了利用亨利福特医疗系统内的这些系统级进步，CR混合计划于2021年2月将其远程医疗模式从一对一的患者对员工咨询8，9转换为WebEx平台（思科），该平台允许三至五名患者在45分钟内以实时方式同时虚拟参与，目标是每个人至少进行30分钟的监督锻炼。2020年秋季，密歇根州的新冠肺炎病例激增，但并不需要对试运营进行重大调整。
12 Journal of Cardiopulmonary Rehabilitation and Prevention 2022; 42: 10-14 www. jcrpjournal. com complete significantly more CR sessions than patients randomized to clinic-based CR alone. Secondary aims are to assess the effect of HYCR on exercise capacity and quality of life. In mid-March 2020, all outpatient clinical and research activities were suspended at Henry Ford Hospital. This policy impacted 26 patients actively engaged in either the standard CR (S-CR) or hybrid CR (combined clinic-and home-based using video synchronized telehealth) arms of the trial. Regardless of study group assignment, for these 26 patients, the number of CR sessions attended at the time CR operations were suspended was used as their total number of sessions completed for the trial (Table). The COVID-19-related suspension directly impacted assessment of the primary trial end points, and the Data and Safety Monitoring Board (DSMB) is evaluating how to include the data from these 26 patients in the statistical analysis. For example, one trial whose primary end point was impacted by COVID-19 excluded all affected participant-related data from their primary analysis but included such data in secondary analyses. 6 In June 2020, new patient enrollment resumed using COVID-19-specific procedures (eg, wearing a mask during CR, individual vs group education). Due to COVID-19, the findings from iATTEND take on increasing importance because the trial evaluates the delivery of CR outside the facility-based setting. 7 Additionally, because of COVID-19, health systems are now better prepared to assist CR programs by adding telehealth-based HYCR programs to their services. To leverage these system-level advances within Henry Ford Health System, in February 2021, the CR hybrid program switched its telehealth model from a one-on-one patient-to-staff encounter8, 9 to a WebEx platform (Cisco) that allows simultaneous and virtual engagement of three to five patients in a real-time manner during a 45-min period, with the goal of at least 30 min of supervised exercise for each person. The autumn 2020 surge in COVID cases in Michigan did not necessitate appreciable alterations in trial operations.