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
复制标题
开发和评估基于数据的快速访问常规临床信息，以加强 COVID-19 社区治疗国家临床平台试验的早期招募
DOI：
10.1101/2021.01.15.21249724
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发表时间：
2021
期刊：
影响因子：
--
通讯作者：
Cake C
中科院分区：
文献类型：
--
作者：
Cake C
背景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。患者招募的标准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，通过在测试结果的大约24-48小时内联系中央NHS测试和跟踪服务最近COVID-19阳性测试结果的人，加强社区护理招聘的道德方法。成立了一个纪律小组，以解决技术、道德、公众认知、后勤和信息管理问题，这些问题是从测试结果数据向研究小组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）反馈所需的。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。一项调查的公众被用来了解公众的看法，使用测试数据为这个拟议的methods. ResultsBefore建立的数据服务，原则上登记平均每周87名参与者。这增加了多达87个额外的人注册每周从测试数据，有助于增加从1013招募到原则在2020年10月开始到2020年12月20日的2802招募。虽然程序的注意事项是由公众咨询确定的，在2639人接触的原则后，积极的测试结果，没有人提出了一个关注被contacted.ConclusionsThis本文介绍了一种新的方法，使用近实时NHS的业务数据招募社区为基础的患者在几天内介绍急性疾病，这种方法增加了招聘和减少阳性测试和随机之间的时间，允许更快速的评估治疗和增加参与者的安全性。端到端的公众和患者参与该方法的设计提供了证据，为信息治理决策提供了依据。试验注册原则由英国研究与创新部和卫生与社会护理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
BackgroundThe 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.MethodsA 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.ResultsPrior 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.ConclusionsThis 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.Trial registrationPRINCIPLE 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. 26/03/2020ISRCTN registry: ISRCTN86534580. 20/03/2020REC number: 20/SC/058IRAS number: 281958
影响因子：
2.5
作者：
Aung T;Haynes R;Barton J;Cox J;Murawska A;Murphy K;Lay M;Armitage J;Bowman L;ASCEND Study Collaborative Group
通讯作者：
ASCEND Study Collaborative Group