gms | German Medical Science

Introduction: User expectations in both research and clinical use have evolved rapidly, driven by the availability of big-data algorithms in research and intuitive mobile devices in routine settings, with requirements from both worlds converging in translational research. When evaluating current off-the-shelf products, it became obvious that available software for data acquisition, processing, and visualisation of physiological monitoring data in acute care settings is not meeting expectations in either field, leading to the decision to start the development of the AcuWave software project [1].

Its key distinguishing feature is the seamless modular integration of user-developed analyses that can access all available data from multiple sources and share a standardised state-of-the art HTML5 user interface [2]. The integration into existing infrastructure and focussing on medical personnel as primary users requires different approaches to design, end-user communication, and support, and poses regulatory, technical, and administrative challenges compared to systems used in a research environment.

Here, we describe our experiences in transferring the AcuWave framework from the research environment into production use as a campus-wide data tool integrated into the existing patient data management software (PDMS).

Methods: The targeted goals were set by evaluating the work of doctoral students using existing medical data [3].

Medical data is sensitive and subject to many regulations and restrictions. To guarantee safety and privacy, AcuWave uses established enterprise authentication services. The data protection concept required by applicable regulations was verified by the institutional data protection officer and roll-out was consented by the employee representation councils. The software was then integrated into the existing PDMS, allowing the user to work directly in the context of the current documentation environment. A logging and monitoring solution [4] was installed to provide error notifications and usage analysis to improve the software quality and stability.

A usability evaluation was conducted to quantify to which extent the implementation met previously defined objectives.

Results: The time and resources needed to transfer a solution developed in a research context into productive clinical environments requirements are often underestimated. Getting clearance from administration, workers’ representation and data protection officials involved actions which took more than four months to complete. Delays induced were significant, although overall effort invested was manageable at less than 10% of technical development efforts required for system integration.

A persisting issue is the necessity to prevent the use for diagnostic or therapeutic purposes as the software is not a certified medical device. User training proved to be vital to the success of non-essential software.

Discussion: AcuWave was added successfully to the toolkit available to clinicians for daily use, demonstrating that roll-out and maintenance of a software developed in a research context into a production environment is feasible. The usage statistics increase but evaluation showed that few users are responsible for the majority of user interactions. Further training and information will be necessary to increase awareness of this tool. Secondary use for scientific purposes is provided in the same environment, ensuring that regulatory requirements are met and the entrance barrier to using the software is lowered.

The authors declare that they have no competing interests.

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