Raimar Kern

Designing an Electronic Patient Management System for Multiple Sclerosis: Building a Next Generation Multiple Sclerosis Documentation System

Background Technologies like electronic health records or telemedicine devices support the rapid mediation of health information and clinical data independent of time and location between patients and their physicians as well as among health care professionals. Today, every part of the treatment process from diagnosis, treatment selection, and application to patient education and long-term care may be enhanced by a quality-assured implementation of health information technology (HIT) that also takes data security standards and concerns into account. In order to increase the level of effectively realized benefits of eHealth services, a user-driven needs assessment should ensure the inclusion of health care professional perspectives into the process of technology development as we did in the development process of the Multiple Sclerosis Documentation System 3D. After analyzing the use of information technology by patients suffering from multiple sclerosis, we focused on the needs of neurological health care professionals and their handling of health information technology. Objective Therefore, we researched the status quo of eHealth adoption in neurological practices and clinics as well as health care professional opinions about potential benefits and requirements of eHealth services in the field of multiple sclerosis. Methods We conducted a paper-and-pencil–based mail survey in 2013 by sending our questionnaire to 600 randomly chosen neurological practices in Germany. The questionnaire consisted of 24 items covering characteristics of participating neurological practices (4 items), the current use of network technology and the Internet in such neurological practices (5 items), physicians’ attitudes toward the general and MS-related usefulness of eHealth systems (8 items) and toward the clinical documentation via electronic health records (4 items), and physicians’ knowledge about the Multiple Sclerosis Documentation System (3 items). Results From 600 mailed surveys, 74 completed surveys were returned. As much as 9 of the 10 practices were already connected to the Internet (67/74), but only 49% preferred a permanent access. The most common type of HIT infrastructure was a complete practice network with several access points. Considering data sharing with research registers, 43% opted for an online interface, whereas 58% decided on an offline method of data transmission. eHealth services were perceived as generally useful for physicians and nurses in neurological practices with highest capabilities for improvements in clinical documentation, data acquisition, diagnosis of specific MS symptoms, physician-patient communication, and patient education. Practices specialized in MS in comparison with other neurological practices presented an increased interest in online documentation. Among the participating centers, 91% welcomed the opportunity of a specific clinical documentation for MS and 87% showed great interest in an extended and more interconnected electronic documentation of MS patients. Clinical parameters (59/74) were most important in documentation, followed by symptomatic parameters like measures of fatigue or depression (53/74) and quality of life (47/74). Conclusions Physicians and nurses may significantly benefit from an electronically assisted documentation and patient management. Many aspects of patient documentation and education will be enhanced by eHealth services if the most informative measures are integrated in an easy-to-use and easily connectable approach. MS-specific eHealth services were highly appreciated, but the current level of adoption is still behind the level of interest in an extended and more interconnected electronic documentation of MS patients.

Multiple sclerosis: clinical profiling and data collection as prerequisite for personalized medicine approach

Multiple sclerosis (MS) is a highly heterogeneous disease as it can present inter-individually as well as intra-individually, with different disease phenotypes emerging during different stages in the long-term disease course. In addition to advanced immunological, genetic and magnetic resonance imaging (MRI) profiling of the patient, the clinical profiling of MS patients needs to be widely implemented in clinical practice and improved by including a greater range of relevant parameters as patient-reported outcomes. It is crucial to implement a high standard of clinical characterization of individual patients as this is key to effective long-term observation and evaluation.To generate reliable real-world data, individual clinical data should be collected in specific MS registries and/or using intelligent software instruments as the Multiple Sclerosis Documentation System 3D. Computational analysis of biological processes will play a key role in the transition to personalized MS treatment. Major breakthroughs in the areas of bioinformatics and computational systems biology will be required to process this complex information to enable improved personalization of treatment for MS patients.

Fampridine response in MS patients with gait impairment in a real-world setting: Need for new response criteria?

Objective: The primary objective of this real-world study was to describe the response to fampridine and changes of gait parameters in multiple sclerosis (MS) patients’ walking disability (Expanded Disability Status Scale (EDSS): 4–7) after treatment with fampridine for 2 weeks as recommended by the European Medicines Agency (EMA) and compare it with the overall physician’s judgement. Methods: A total of 211 adult MS patients were analyzed using a multimodal gait assessment including the timed 25-foot walk test (T25FW), 2-minute walking test (2-MWT), 12-item Multiple Sclerosis Walking Scale (MSWS-12), the GAITRite electronic walkway system, and the patients’ clinical global impression (CGI). Multimodal gait assessment was compared with the clinician’s impression of overall improvement after 2 weeks. Results: In total, 189 subjects were included, of which 133 (70.37%) were responders to fampridine (RF), according to physician’s judgement. Looking at independent multimodal gait assessment, RFs showed improvement of 12.60% in the T25FW, 19.25% in the 2-MWT, 21.12% in the MSWS-12, and 6.54% in their Functional Ambulation Profile (FAP) score. The combination of the T25FW and the MSWS-12 would offer the best sensitivity and specificity for determining response to fampridine according to both neurologists’ and patients’ classification. Conclusion: This study provides new information on the use of fampridine in a real-world setting with a large patient sample on the potential benefit of using more definitive responder criteria to fampridine for the clinical setting.

Mehr als dokumentieren: computerunterstütztes Patientenmanagement

Mit Blick auf die zunehmend komplexeren Therapien entwickelte die eHealth-Projektgruppe des Universitätsklinikums Dresden ein innovatives computerbasiertes Patientenmanagementsystem MSDS3D im Bereich der Multiplen Sklerose (MS), das multidimensional und interaktiv Daten von Arzt, Schwester und Patienten integriert. Das System kann nicht nur Daten des Patienten erfassen und interpretieren, sondern auch interaktiv Informationen an den Patienten vermitteln. Im Rahmen von MSDS3D können die für die Anwendung komplexer Therapien innerhalb eines definierten klinischen Pfads notwendigen Vor- und Begleituntersuchungen abgebildet werden, wie auch Befragungen der Patienten zu verschiedenen Aspekten ihrer Erkrankung.

Improving multiple sclerosis management and collecting safety information in the real world: the MSDS3D software approach

ABSTRACT Introduction: For safety evaluation, randomized controlled trials (RCTs) are not fully able to identify rare adverse events. The richest source of safety data lies in the post-marketing phase. Real-world evidence (RWE) and observational studies are becoming increasingly popular because they reflect usefulness of drugs in real life and have the ability to discover uncommon or rare adverse drug reactions. Areas covered: Adding the documentation of psychological symptoms and other medical disciplines, the necessity for a complex documentation becomes apparent. The collection of high-quality data sets in clinical practice requires the use of special documentation software as the quality of data in RWE studies can be an issue in contrast to the data obtained from RCTs. The MSDS3D software combines documentation of patient data with patient management of patients with multiple sclerosis. Following a continuous development over several treatment-specific modules, we improved and expanded the realization of safety management in MSDS3D with regard to the characteristics of different treatments and populations. Expert opinion: eHealth-enhanced post-authorisation safety study may complete the fundamental quest of RWE for individually improved treatment decisions and balanced therapeutic risk assessment. MSDS3D is carefully designed to contribute to every single objective in this process.

Perceptions on the value of bodily functions in multiple sclerosis

In neurological diseases presenting with a plethora of symptoms, the value of bodily functions for a given patient might be a guide for clinical management. Multiple sclerosis (MS) is paradigmatic in this respect, and little is known about the value of different bodily functions of patients and their physicians’ perceptions.

Limited Time from the Diabetes Patients' Perspective: Need for Conversation with the Eye Specialist

Purpose: Facing the lack of time, busy retina consultants should be aware of how the patients would prefer that time is spent and whether they wish the specialist to talk more at the expense of other medical activities. Methods: 810 persons with diabetes were asked to divide the time of 10 min between examination, consultation and treatment when envisioning a real-life scenario of diabetic retinopathy (NCT02311504). Results: With the increasing duration of diabetes, patients wanted significantly more time for diagnostics (p = 0.028), while age was found to be associated with less time for treatment (p = 0.009). Female subjects tended to prefer only little more time for talking (p = 0.051) in comparison with males, who slightly favored therapy (p = 0.025). Conclusions: The large majority recognized the need for diagnostics in their allocation of time. If individual patients are confronted with the health care perspective of time constraints, this might improve the understanding of prioritization.