JMIR Publications

ABSTRACT

Background:

Clinical trials are essential for medical research and thus 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. The Patient Recruitment Systems KAS+ and recruIT have been tested as part of the MIRACUM project.

Objective:

With this evaluation, our goal is to investigate whether and to what extent two different evaluated tools can meet the requirements resulting from the first requirements analysis. A user survey is conducted to determine whether the tools are usable in practice and helpful for the trial staff. Furthermore, it will be investigated whether the test phase reveals further requirements for recruitment tools that were not considered in the first place.

Methods:

We performed semi-structured interviews with ten participants who used the patient recruitment tools for at least one month with currently recruiting trials. In a next step, the interviews were transcribed and analyzed by Meyering’s method. The identified statements of interviewees were categorized into five groups of requirements and sorted by their frequency.

Results:

The evaluated tools fulfill seven and eleven requirements of the twelve previously identified, respectively. Interview participants mentioned the need of different notification schedules, integration into their workflow, different queryable patient characteristics and unpseudonymized screening lists. This resulted in a list of new requirements for the implementation or enhancements of Patient Recruitment Systems.

Conclusions:

Trial staff report a huge need of support in the identification of eligible trial subjects, whereas the workflows in patient recruitment are differing. For better suitability of the recruitment systems in the workflow of different kinds of trials, we recommend the implementation of an adjustable notification schedule of the 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 any criticism, all participants confirmed to use the Patient Recruitment Systems again.