Embedding randomised trials within routine care

研究人员越来越多地以电子形式获得医疗记录、登记和医院活动统计中收集的个人健康数据。在实现连通性、数据连接和安全方面取得的进展，现在为更好地将这些数据用于研究目的提供了可能性。识别潜在合格参与者并通过卫生系统对其进行随访以获得结果数据的能力，有助于将随机试验嵌入常规临床实践中。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将如何改善招募患者参加临床试验的过程确定为首要任务1。创新的数据支持研究设计可以填补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年在英国队列中进行的NIHR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数据质量的任何评估。此外，大流行病提高了人们对在常规护理中嵌入试验的能力的认识，引发了与电子同意书、电子PRO数据采集等相关的后续发展。学生将包括什么学生将通过更新早期的试验方案2来描述谁在做什么、何时和为什么来了解该领域。他们将对（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;以及（ii）数据控制人员，从试验人员的角度了解设计阶段与试验人员的互动。本研究可能会出现各种问题，根据学生的兴趣和经验，为学生提供进一步研究的选择。其中可能包括：理解参与患者报告的结局数据收集，评估数据质量，理解和参与卫生专业人员和患者，提高对即将发布的SPIRIT常规指南的依从性，国际视角。关键词：医疗保健系统数据，结局，临床试验，随机收集的数据，数据有效性，登记研究，随机收集的健康数据，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