User Requirements for an Electronic Patient Recruitment System: Semistructured Interview Analysis After First Implementation in 3 German University Hospitals.

Background: Clinical trials are essential for medical research and medical progress. Nevertheless, trials often fail to reach their recruitment goals. Patient recruitment systems aim to support clinical trials by providing an automated search for eligible patients in the databases of health care institutions like university hospitals. To integrate patient recruitment systems into existing workflows, previous works have assessed user requirements for these tools. In this study, we tested patient recruitment systems KAS+ and recruIT as part of the MIRACUM (Medical Informatics in Research and Care in University Medicine) project.

Objective: Our goal was to investigate whether and to what extent the 2 different evaluated tools can meet the requirements resulting from the first requirements analysis, which was performed in 2018-2019. A user survey was conducted to determine whether the tools are usable in practice and helpful for the trial staff. Furthermore, we investigated whether the test phase revealed further requirements for recruitment tools that were not considered in the first place.

Methods: We performed semistructured interviews with 10 participants in 3 German university hospitals who used the patient recruitment tools KAS+ or recruIT for at least 1 month with currently recruiting trials. Thereafter, the interviews were transcribed and analyzed by Meyring method. The identified statements of the interviewees were categorized into 5 groups of requirements and sorted by their frequency.

Results: The evaluated recruIT and KAS+ tools fulfilled 7 and 11 requirements of the 12 previously identified requirements, respectively. The interviewed participants mentioned the need for different notification schedules, integration into their workflow, different patient characteristics, and pseudonymized screening lists. This resulted in a list of new requirements for the implementation or enhancement of patient recruitment systems.

Conclusions: Trial staff report a huge need of support for the identification of eligible trial participants. Moreover, the workflows in patient recruitment differ across trials. For better suitability of the recruitment systems in the workflow of different kinds of trials, we recommend the implementation of an adjustable notification schedule for screening lists, a detailed workflow analysis, broad patient filtering options, and the display of all information needed to identify the persons on the list. Despite criticisms, all participants confirmed to use the patient recruitment systems again.