Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments.
Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments.
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DOI：
10.1186/s13063-021-05965-4
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发表时间：
2022-01-20
期刊：
影响因子：
2.5
通讯作者：
Butler C
中科院分区：
文献类型：
--
作者：
Cake C;Ogburn E;Pinches H;Coleman G;Seymour D;Woodard F;Manohar S;Monsur M;Landray M;Dalton G;Morris AD;Chinnery PF;UK COVID-19 National Core Studies Consortium;Hobbs FDR;Butler C
COVID-19大流行为快速设计、启动和交付治疗性临床试验提出了独特的挑战。PRINCIPLE（Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses）是英国的一个国家平台，旨在调查社区中高并发症风险老年人COVID-19治疗的再利用疗法。标准的患者招募方法未能满足所需的招募速度和规模。本文描述了一种近实时、数据驱动、符合伦理的方法的开发和评估，该方法通过在测试结果发布后约24-48小时内联系最近从中央NHS测试和跟踪服务获得COVID-19阳性测试结果的人，来加强社区护理的招募。成立了一个多学科团队，以解决技术、伦理、公众认知、后勤和信息管理问题，以便从测试结果数据向研究团队提供潜在试验参与者的近实时（大约在收到阳性测试的24-48小时内）反馈。PRINCIPLE还获得了对简要护理记录（SCR）的唯一访问权限，以确保安全处方，并使试验团队能够快速安全地将知情同意的患者纳入试验。一项公众调查被用来了解公众的看法，使用测试数据，这一拟议的方法。在建立数据服务之前，PRINCIPLE平均每周登记87名参与者。从测试数据来看，每周注册人数增加了87人，使PRINCIPLE的招聘人数从2020年10月初的1013人增加到2020年12月20日的2802人。虽然公众咨询确定了程序上的注意事项，但在PRINCIPLE在检测结果呈阳性后联系的2639人中，没有人对被接触表示担忧。本文描述了一种新的方法，使用近实时NHS的操作数据，招募以社区为基础的患者在几天内提出急性疾病。这种方法增加了招募，减少了阳性测试和随机化之间的时间，允许更快速地评估治疗并提高参与者的安全性。端到端的公众和患者参与设计的方法提供了证据，为信息治理决策提供信息。PRINCIPLE由英国研究和创新部以及卫生和社会保健部通过国家卫生研究所资助。EudraCT编号：2020-001209-22。26/03/2020 ISRCTN登记：ISRCTN 86534580。20/03/2020 REC编号：20/SC/058 IRAS编号：281958在线版本包含补充材料，可通过10.1186/s13063-021-05965-4获得。
The COVID-19 pandemic has presented unique challenges for rapidly designing, initiating, and delivering therapeutic clinical trials. PRINCIPLE (Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses) is the UK national platform investigating repurposed therapies for COVID-19 treatment of older people in the community at high risk of complications. Standard methods of patient recruitment were failing to meet the required pace and scale of enrolment. This paper describes the development and appraisal of a near real-time, data-driven, ethical approach for enhancing recruitment in community care by contacting people with a recent COVID-19 positive test result from the central NHS Test and Trace service within approximately 24–48 h of their test result. A multi-disciplinary team was formed to solve the technical, ethical, public perception, logistical and information governance issues required to provide a near-real time (approximately within 24–48 h of receiving a positive test) feed of potential trial participants from test result data to the research team. PRINCIPLE was also given unique access to the Summary Care Record (SCR) to ensure safe prescribing, and to enable the trial team to quickly and safely bring consented patients into the trial. A survey of the public was used to understand public perceptions of the use of test data for this proposed methodology. Prior to establishing the data service, PRINCIPLE registered on average 87 participants per week. This increased by up to 87 additional people registered per week from the test data, contributing to an increase from 1013 recruits to PRINCIPLE at the start of October 2020 to 2802 recruits by 20 December 2020. Whilst procedural caveats were identified by the public consultation, out of 2639 people contacted by PRINCIPLE following a positive test result, no one raised a concern about being approached. This paper describes a novel approach to using near-real time NHS operational data to recruit community-based patients within a few days of presentation with acute illness. This approach increased recruitment and reduced time between positive test and randomisation, allowing more rapid evaluation of treatments and increased safety for participants. End-to-end public and patient involvement in the design of the approach provided evidence to inform information governance decisions. PRINCIPLE is funded by UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research. EudraCT number: 2020-001209-22. 26/03/2020 ISRCTN registry: ISRCTN86534580. 20/03/2020 REC number: 20/SC/058 IRAS number: 281958 The online version contains supplementary material available at 10.1186/s13063-021-05965-4.
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