CBmed Biomarker Research: Clinical Studies in the Diabetes Outpatient Department

  • Two weeks after project start, first form processes were already active

  • 3-months pilot project with 20 users and 150 patients

  • Successful productive operation for over 5 years with more than 1,300 patients

The Medical University of Graz captures patient data for diabetes research digitally and in a structured way with HybridForms. Data from patients’ written informed consent forms, results of medical visits, and protocols of medical examinations are captured digitally with tablets for the biomarker research diabetes registry.

HybridForms: Digital forms in medicine & research

The goal of the diabetes registry for biomarker research is to capture a representative cohort of patients routinely treated at the University Hospital Graz. Consents for participation in the clinical trials as well as data from individual medical visits and patient interviews are collected on tablets using the HybridForms mobile App.

All results are securely archived and transfered pseudonymized via interface to the clinical trial software. During pseudonymization, the patient’s name is replaced by a pseudonym (Study Subject ID) to protect the identity of individual patients. However, this procedure preserves the references between different data sets for further analysis.

Digitization makes all data available more quickly for further evaluations and scientific research – and the error rate is minimized thanks to transparent and consistently traceable documentation.

About CBmed Biomarker Research

CBmed (Center for Biomarker Research in Medicine) combines excellent research infrastructure, scientific competence, medical expertise, national and international companies for systematic biomarker research in medicine.
CBmed thus contributes to the development of technologies with which diseases can be diagnosed at an early stage and thus treated – including cancer, diabetes and heart attacks.
The competence center is owned by, among others, the Medical University of Graz and the Medical University of Vienna.

The project »Clinical Studies in the Diabetes Outpatient Department« was carried out by the HybridForms integration partner Kapsch BusinessCom.
Kapsch BusinessCom supports inter­national companies and organizations in Smart Hospital, Health & Social Care with the digital trans­formation and optimization of their processes.

Digital informed consent & protocols of medical visits for the diabetes outpatient department at the Medical University of Graz with HybridForms

CBmed: Clinical Studies in the Diabetes Outpatient Department
CBmed: Clinical Studies in the Diabetes Outpatient Department
Harald Sourij, CBmed Biomarker Research

»The tablet-based data entry with HybridForms allows us to perform data collection in the Diabetes Biomarker Research Registry much faster, more efficiently and much more securely. I am convinced that we will come across this model very frequently in other future research projects.«

Univ.-Prof. Dr.med. Harald Sourij | Clinical Department of Endocrinology and Diabetology, Medical University of Graz ↗
Martin Schober, Kapsch BusinessCom

»As an implementation partner, HybridForms allows us to focus fully on our customers’ challenges – and thus achieve outstanding project results in short lead times.«

Dipl.-Ing. Martin Schober | Head of Software Development Region South, K-Businesscom ↗
Logo CBmed Biomarker Research
Logo MedUni Graz
Logo K-Businesscom
CBmed: Digital transformation with HybridForms

Intelligent data acquisition in medicine and research: mobile, cross-platform & user-friendly – for traceability in the documentation of processes

Requirements

Until now, paper survey forms were used for clinical studies and the data was recorded by hand by the study personnel. In the case of longer studies, thousands of individual protocols often had to be collected on paper, subsequently typed or scanned so that they were available in the clinical database. If archiving was done in file folders, later search and evaluation was only possible with considerable effort.

In addition to the large amounts of paper that had to be kept, the subsequent transfer to the databases was a frequent source of errors that could lead to repeatedly incorrect – and thus unusable – data. Also, the possibilities for further important annotations were limited on the paper forms.

Solution with HybridForms already in the pilot project

  • Digitization workshop by HybridForms Solution Partner Kapsch BusinessCom with process analysis and design of a digital prototype.
  • Secure pilot project on servers of the Medical University of Graz in real process with selected pilot users and patients.
  • Go live of the digital form processes tested in everyday clinical use directly after the pilot project, running since 2015.
  • Direct added value through secure enterprise features such as biometric signatures, interactive assistance functions, and plausibility checks.

Learning and benefits in daily clinical use

  • Extremely reduced lead times and fast digital availability

  • High data quality with checking during input and thus fewer errors
  • Pseudonymization and secure protocol storage immediately after capture
  • Complete digital data for research and scientific analysis
HybridForms: CBmed Biomarker Research Team

HybridForms App & Software with secure enterprise features: »Tablet instead of clipboard« for higher data quality, more transparency & more efficient clinical processes

Biometrically secure signature

  • Handwritten signatures with pen directly on the tablet
  • Storing the biometric characteristics according to ISO 19794-7

  • GDPR compliant encryption of biometrics directly on the device

Authentic: Legally binding consent and documentation

End-to-end digital workflow

  • Digital workflow from capture to evaluation
  • Examination data are anonymized for the clinical study
  • For this use of an artificial (Study Subject ID)

Automated processes: More transparency and full security

Optimal mobile form usability

  • Validation of data during input, defined mandatory fields, etc.
  • Annotate photos & diagrams with advanced sketch function

  • Automatic calculations like BMI or waist-hip ratio

High data quality: Structured input and interactive functions

Smart Health & Social Care

Administrative form-based processes are optimized through digitization with HybridForms, and healthcare professionals can work more efficiently with mobile & digital tools.

User-friendly pre-filled forms with integration of data from third-party systems (e.g. HIS) are processed via App on tablets and smartphones, and the entries are checked automatically. All data, photos and signatures are in one document – secure, traceable and legally valid.

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