gms | German Medical Science

Introduction: Investigators of clinical trials are responsible for reporting unexpected adverse reactions and adverse events in an appropriate timeframe [1], [2], [3]. Study patients may be treated by another physician in a different medical context. In such case, the physician requires the knowledge of the patient’s study participation to inform the study’s investigator. The information, whether a patient participates in a clinical study, should at least be available in the clinical department being involved in the study. Currently, information about patient’s study participation is not present in the local clinical information system (CIS), ORBIS by AGFA HealthCare [4], used at the University Hospital Münster (UKM). Additional information, such as the investigator’s contact details, is also needed to provide a proper management of all performed studies at the clinic. Furthermore, the registration of a study patient often requires pseudonymization and randomization. Thus, an integration of these services into the registration process would create a less fragmented workflow and would reduce documentation redundancies.

Objective of this research is to create a technical and organizational infrastructure for providing knowledge of patients’ study participation and study management directly within the CIS.

Methods: Different approaches to achieve the objective with the provided functionality by ORBIS were analyzed. Pseudonymization and randomization services suitable for the integration into the CIS were elaborated. The proposed solution was evaluated by study nurses and research physicians from different departments of the UKM. Time reduction compared to a stand-alone pseudonymization and randomization workflow was measured, and a usability evaluation was conducted using the system usability scale by Brooke [5].

Results: An ORBIS form has been implemented which supports the registration of patients to studies and is in line with data protection guidelines. Clinical studies can be selected from a drop down list based on the user’s department affiliation. If a study is not contained in the list, it can be added easily within the form. Patients can be manually registered for the selected study. Additionally, an automatic patient pseudonymization with the Mainzelliste [6] as well as an in-house solution for different randomization algorithms can be applied. Also, the patient’s study participations are clearly listed and additional study information can be obtained. The evaluation showed a good usability and a significant time reduction archived by the integration of services.

Discussion: The proposed solution accomplishes the defined objective. Furthermore, it enables study dependent reports and the reporting of adverse events can be supported by existing automated processes [7]. The evaluation has shown the feasibility of the approach and all departments gave positive feedback regarding future usage. However, larger trials and especially multi-centric studies still require an external electronic data capture system. Thus, for larger studies the effort of double documentation remains. Also, the implementation does not replace the functionality of clinical trial management systems. As next step, the form should be established in routine as part of a pilot phase to gather feedback from study nurses and research physicians in the context of their daily workflow, which may result in slight adjustments of the form.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.