Accepted for/Published in: JMIR Medical Informatics
Date Submitted: Mar 12, 2021
Date Accepted: Dec 4, 2021
Patient Recruitment System for Clinical Trials: A Mixed-Methods Study about Requirements at 10 University Hospitals
ABSTRACT
Background:
Clinical trials are the gold standard for advancing medical knowledge and improving patient outcomes. For their success, an appropriately sized cohort is required. However, patient recruitment remains one of the most challenging aspects of clinical trials. IT support systems, for instance patient recruitment systems, may help overcome existing challenges and improve recruitment rates, when customized to the user needs and environment.
Objective:
The goal of our research is to describe the status quo of patient recruitment processes and to identify user requirements for the development of a patient recruitment system.
Methods:
We conducted an online survey with 56 participants as well as semi-structured interviews with 33 participants from ten German university hospitals.
Results:
We here report the recruitment procedures and challenges of ten university hospitals. The recruitment process was influenced by diverse factors such as the ward, the use of software, and the study inclusion criteria. Overall, clinical staff seemed more involved in patient identification, while the research staff focused on screening tasks. Ad-hoc as well as planned screenings were common. Identifying eligible patients was still associated with significant manual efforts. The recruitment staff used Office applications because tailored software was not available. In order to implement such software, data from disparate sources will need to be made available. We discussed concrete technical challenges concerning patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration, and we contributed to the support of developing a successful system.
Conclusions:
Identifying eligible patients is still associated with significant manual efforts. To fully make use of the high potential of IT in patient recruitment, many technical and process challenges have to first be solved. We contribute and discuss concrete technical challenges for patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration.
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Copyright
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