Praxis-Studien-Manager

The Practice Study Manager (Praxis-Studien-Manager, PStM) is part of the DEGAM-ForNet IT infrastructure in Germany. It is deployed to research practices within general practice-based research networks (GPBRN) which are part of the DEGAM-ForNet initiative. It allows them to participate in ongoing studies and assists them throughout the process to minimize the workload for practice staff.

Patient-identifying data (IDAT) are exclusively stored in the PStM that is installed locally in practices. Only information entered into data capture forms is transmitted and stored centrally. This ensures that only predefined study data leave the practice and only with the patient's explicit informed consent. The central counterpart to the PStM is the Central Research Manager (Zentraler Forschungs-Manager, ZFM), which is used to manage studies and collect data centrally.

Features

The following processes and features are currently implemented:

• Case Finding: Identifying potentially eligible patients based on study criteria
• Recruiting: Contacting, recruiting and enrolling eligible patients
• Execution: Collecting study data using structured forms
• Study completion: Verifying that all required tasks have been completed using a checklist
• Exclusion of participants from the study
• Reporting adverse events
• Importing patient lists from the PDMS via Excel- or CSV-format

The main advantages of using this software are:

• Reduced practice workload through digitalization
• Automation of study processes such as enrollment or randomization
• Improved data quality due to reliably checked study criteria
• Live monitoring of the progress of a practice and its participants

Installation

Note:* This is the installation guide for developers*. If you want to install this software in a practice participating in a DEGAM-ForNet study, you must follow the official guide in our wiki.

Requirements:

• Docker Engine 27.4.1 or newer
• Docker Compose v2.32 or newer

Installation steps:

1. Clone this repository
2. Create a copy of template.env, rename it to .env and adjust the settings as needed.
3. Start the project with docker compose up --build

Citation

We kindly request that any works based on this software cite the following work:

@article{schmutz2024fopranetbw,
  title = {FoPraNet-BW: An Infrastructure for Clinical Studies in Practice-Based Research Networks in the German Health System},
  author = {Patrick Schmutz and Arthur Krau{\ss} and Sven D{\"o}rflinger and Arndt Becker and Roland Koch and Andreas Polanc and Elke Feil and Claudia Salm and Karin Scheeser and Frank Peters-Klimm and Christian Thies},
  journal={Studies in health technology and informatics},
  volume={316},
  pages={190--194},
  year={2024},
  doi={10.3233/SHTI240376}
}

Contributing

This project is currently developed and maintained by the Artemis research group at Reutlingen University.

Feedback, issue reports and input of all forms are highly appreciated. While our resources for reviewing and implementing external requests are currently limited, we are dedicated to monitoring and responding to them regularly.

If you are interested in contributing to the software or collaborating on research use cases, please contact us at it@degam-fornet.de.