Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals

Fitzer K, Haeuslschmid R, Blasini R, Altun FB, Hampf C, Freiesleben S, Macho P, Prokosch HU, Gulden C (2022)

Publication Type: Journal article

Publication year: 2022

Journal

JMIR Medical Informatics JMIR Publications

Book Volume: 10

Article Number: e28696

Journal Issue: 4

DOI: 10.2196/28696

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. Information technology (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 study 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 a web-based survey with 56 participants as well as semistructured interviews with 33 participants from 10 German university hospitals. Results: We here report the recruitment procedures and challenges of 10 university hospitals. The recruitment process was influenced by diverse factors such as the ward, 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 and planned screenings were common. Identifying eligible patients was still associated with significant manual efforts. The recruitment staff used Microsoft Office suite because tailored software were not available. 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 be solved first. We contribute and discuss concrete technical challenges for patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration.

Authors with CRIS profile

Hans-Ulrich Prokosch Lehrstuhl für Medizinische Informatik Christian Gulden Lehrstuhl für Medizinische Informatik

Involved external institutions

Universitätsmedizin Greifswald / Universitätsklinikum Greifswald DE Germany (DE) Universitätsklinikum Freiburg DE Germany (DE) Justus-Liebig-Universität Gießen DE Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) DE Germany (DE) Universitätsmedizin der Johannes Gutenberg-Universität Mainz DE Germany (DE)

How to cite

APA:

Fitzer, K., Haeuslschmid, R., Blasini, R., Altun, F.B., Hampf, C., Freiesleben, S.,... Gulden, C. (2022). Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals. JMIR Medical Informatics, 10(4). https://dx.doi.org/10.2196/28696

MLA:

Fitzer, Kai, et al. "Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals." JMIR Medical Informatics 10.4 (2022).

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