Embedding randomised trials within routine care

在医疗记录、登记和医院活动统计中收集的有关个人健康的数据越来越多地以电子形式供研究人员使用。在实现连通性、数据链接和安全性方面取得的进展，现在为更好地利用这些数据进行研究提供了可能。识别潜在符合条件的参与者并通过卫生系统对其进行随访以获取结果数据的能力，有助于将随机试验纳入常规临床实践。“随机试验如何成为常规护理的一部分，并最好地利用当前的临床护理途径？”在一项研究中，患者、护理人员和医疗保健专业人员确定了如何改善临床试验招募过程的首要研究事项。创新的基于数据的研究设计可以回答研究证据中紧迫的知识空白。然而，目前尚不清楚这些数据来源在多大程度上被用于研究，以提供有效的临床试验，可能是大规模的。最近的一项研究发现，2019年在英国进行的由国家卫生研究院资助的试验中，约有一半计划从常规收集的健康数据（RCHD）来源收集结果数据。然而，很少有试验团队在其方案中描述了对rchd数据质量的评估。此外，大流行提高了人们对将试验纳入常规护理的能力的认识，引发了与电子同意、电子pro数据采集等相关的后续发展。学生将包括哪些内容学生将通过更新先前对试验方案的审查来了解该领域2，以描述谁在做什么、何时做什么和为什么做什么。他们将与(i)试验人员进行调查和/或结构化访谈，以了解设计选择的基本原理，包括与数据源相关的设计选择；（ii）数据控制器，从他们的角度理解在设计阶段与试验人员的交互。这项研究可能会产生各种各样的问题，为学生提供进一步研究的选择，这取决于他们的兴趣和经验。这些可能包括：理解参与患者报告的结果数据收集、数据质量评估、卫生专业人员和患者的理解和参与、改进对即将出台的SPIRIT-Routine指南的遵守、国际视野。关键词：医疗保健系统数据，结果，临床试验，常规收集数据，数据有效性，注册表，常规收集健康数据，随机临床试验

Data collected about an individual's health in medical records, registries and hospital activity statistics is becoming increasingly accessible to researchers in an electronic form. Progress in achieving connectivity, data linkage and security now offers the possibility of better use of this data for research purposes. The ability to identify potentially eligible participants and follow them up through the health system for outcome data is facilitating the embedding of randomised trials within routine clinical practice. 'How can randomised trials become part of routine care and best utilise current clinical care pathways?' was identified as the number one priority in a study amongst patients, carers and healthcare professionals of research priorities for how to improve the process of how people are recruited to clinical trials1.Innovative data-enabled study designs can answer pressing knowledge gaps in research evidence. However, the extent to which such sources of data are now being employed in research to deliver efficient clinical trials, potentially at a wide scale, is unclear. A recent study2 found that around half of NIHR-funded trials ongoing in 2019 in a UK cohort planned to collect outcome data from routinely collected health data (RCHD) sources. However very few trial teams described any assessments of data quality from RCHDs in their protocol. In addition, the pandemic has increased awareness about the ability of embedding trials in routine care, provoking consequent developments in relation to e-consent, e-PRO data capture, etc.What the studentship will encompass The student will gain an understanding of the area through an update of the earlier review of trial protocols2 to describe who is doing what, when and why. They will undertake a survey and/or structured interviews with (i) trialists, to understand the rationale for design choices, including those related to data sources; and (ii) data controllers, to understand interactions with trialists during the design phase from their perspectives. Various issues may emerge from this research, providing the student with options for further research depending on their interest and experience. These may include: understanding engagement with patient-reported outcome data collection, assessment of data quality, understanding and engagement of health professionals and patients, improving adherence to forthcoming SPIRIT-Routine guidelines, international perspectives.Keywords:Healthcare systems data, Outcomes, Clinical trials, Routinely collected data, Data validity, Registries, Routinely collected health data, Randomised clinical trials