Charis Xuan Xie is a PhD student in the Wellcome Trust Health Data in Practice programme at Queen Mary University of London. She holds an MSc in Health Information Systems from the University of Melbourne in Australia.
Prior to her PhD, she worked as a research assistant at Monash University, evaluating the accuracy of smartwatch technology for the diagnosis of Atrial Fibrillation. She then worked at The University of Sydney on a systematic review of the effectiveness of clinical dashboards on medication use and test ordering.
Charis’ research interests are primarily in the field of digital health, implementation science and health data science. Currently, her doctoral work explores the use of routine healthcare data in improving the efficiency of randomised implementation trials.
Routine healthcare data (RHD) are increasingly used in randomised controlled trials evaluating healthcare interventions. It can aid participant identification, outcome assessment and intervention delivery. Some trials evaluating the effectiveness of strategies designed to improve the uptake of evidence-based practice are referred to as implementation trials. However, little is known about RHD use in randomised implementation trials (RITs). This review aims to describe the methodological characteristics concerning how RHD have been used in RITs.
We searched MEDLINE (Ovid), Cochrane Methodology Registry and Cochrane Central Register of Controlled Trials from Jan 2000 to Dec 2021, and manually searched protocols from trial registers. We included implementation trials and type II and type III hybrid effectiveness-implementation trials conducted using RHD. We conducted a mixed-method approach to extract quantitative and qualitative data and narratively synthesise findings.
We included 80 RITs, of which multicomponent implementation strategies were commonly evaluated (70.0%), as opposed to single strategies. The most frequently implemented evidence-based interventions were clinical guidelines (22.5%). Most trials assessed adoption as the implementation outcome (65.0%). The majority of trials used data from electronic health records (EHRs) (62.5%); RHD were predominantly used in a combination of participant identification, intervention delivery and outcome assessment (58.8%). Seven themes of reported rationales for using RHD were validating results, increasing efficiency, assessing outcomes, reducing research burden, improving quality of care, identifying study samples, and assessing representativeness. Four themes of barriers and facilitators were data quality, EHR systems, research governance and external factors.
Identifying the implementation trials was difficult due to poor trial reporting. Further work is required to enhance the adoption of and adherence to existing guidelines on designing and reporting implementation studies. Additional work is needed to harmonise the language used in describing implementation strategies and implementation outcomes. Routine healthcare data are promising in supporting the implementation of evidence-based interventions. Data derived from EHRs have been widely used for participant identification, outcome assessment and intervention delivery. However, barriers exist that prevent routine data from achieving its full potential. Future research should focus on improving data quality and delivery, and optimising healthcare data systems.
Registration: PROSPERO CRD42022292321
Acknowledgements: This work is funded by the Wellcome Trust [224863/Z/21/Z] and supported by the National Institute for Health Research ARC North Thames. The views expressed in this publication are those of the author(s) and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care.