J Neural Transm (2013) 120 (Suppl 1):S61–S66 DOI 10.1007/s00702-013-1041-x
NEUROLOGY AND PRECLINICAL NEUROLOGICAL STUDIES - REVIEW ARTICLE
Multiple sclerosis documentation system (MSDS): moving from documentation to management of MS patients Tjalf Ziemssen • Raimar Kempcke • Marco Eulitz • Lars Großmann • Alexander Suhrbier • Katja Thomas Thorsten Schultheiss
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Received: 21 March 2013 / Accepted: 14 May 2013 / Published online: 1 June 2013 Ó Springer-Verlag Wien 2013
Abstract The long disease duration of multiple sclerosis and the increasing therapeutic options require a individualized therapeutic approach which should be carefully documented over years of observation. To switch from MS documentation to an innovative MS management, new computer- and internet-based tools could be implemented as we could demonstrate with the novel computer-based patient management system ‘‘multiple sclerosis management system 3D’’ (MSDS 3D). MSDS 3D allows documentation and management of visit schedules and mandatory examinations via defined study modules by integration of data input from various sources (patients, attending physicians and MS nurses). It provides forms for the documentation of patient visits as well as clinical and diagnostic findings. Information can be collected via interactive touch screens. Specific modules allow the management of highly efficacious treatments as natalizumab or fingolimod. MSDS can be used to transfer the documented data to databases as, e.g. the registry of the German MS society or REGIMS. MSDS has already been implemented successfully in clinical practice and is currently being evaluated in a multicenter setting. High-
Contact details: Information about the MSDS system is available on http://msdsweb.med.tu-dresden.de. T. Ziemssen (&) R. Kempcke L. Großmann A. Suhrbier K. Thomas T. Schultheiss MS Center Dresden, Center of Clinical Neuroscience, University Hospital Carl Gustav Carus, Dresden University of Technology, Fetscherstr. 74, 01307 Dresden, Germany e-mail:
[email protected] T. Ziemssen M. Eulitz K. Thomas T. Schultheiss Department of Neurology, University Hospital Carl Gustav Carus, Dresden University of Technology, Fetscherstr. 74, 01307 Dresden, Germany
quality management and documentation are crucial for improvements in clinical practice and research work. Keywords Multiple sclerosis Multiple sclerosis documentation system Management Database
Introduction Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) which is clinically characterized by relapsing–remitting, secondary and primary chronic progressing forms (Compston and Coles 2002). As pathological and anatomical correlates of this disease, there are not only lesions with inflammatory demyelination, but also axonal damage as well as nerve cell loss takes place (Trapp et al. 1998). Due to the facts that first MS symptoms most frequently occur between the second and the fourth decade of life and that life expectancy is only mildly affected, if at all, MS is a prototype of a chronic disease which after having been diagnosed requires lifelong continuous therapeutic counseling (MacLean 2004; Whitaker et al. 1995). Therefore, large amounts of data accumulate as care and treatment progress (Fugger et al. 2009). The use of specific treatments such as natalizumab or fingolimod depends on the presence of defined disease characteristics (frequency and severity of relapses, findings of magnetic resonance imaging) (Gasperini et al. 2013; Giovannoni et al. 2007; Berger et al. 2010). The evaluation of effective immunomodulation over the long term in individual patients may be difficult due to the variable disease courses (Evans et al. 2012). For the prescription of certain symptomatic therapies (e.g. fampridine, nabiximol), the beneficial effects in a given patient have to be documented (Sobek et al. 2012).
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When psychological symptoms such as depression, fatigue or decline in cognitive performance complicate the clinical course of MS and findings from other disciplines (e.g. urology, ophthalmology, neuroradiology) add to the patients chart, a specific and standardized computer-based documentation may be of considerable value (Ziemssen 2009, 2011). In addition to adding transparency to clinical data, such a system may improve the communication between the different caregivers accompanying individual patients (Lugaresi et al. 2012). Automatic calculations support the systematic application of established scales which are indispensible for the quantification of neurologic deficits overtime. The Expanded Disability Status Scale (EDSS) or the multiple sclerosis functional composite (MSFC) are helpful for the guidance of MS therapy (Confavreux and Paty 1995). To improve the documentation and management of MS patients, the multiple sclerosis documentation system (MSDS) which is available in different versions has been developed in the last years. The following review article aims at describing history, main features and future developments of MSDS.
MSDS clinic From 1999 to 2004, the MSDS project group in Dresden, supported by the Hertie foundation, developed MSDS Clinic and distributed the database mainly at different University Hospitals in Germany (Pette and Eulitz 2002; Pette and Zettl 2002). This software allowed the input of patients’ personal data, a structured history and clinical examination, clinical scores and treatment details. With its final version (MSDS Clinic 3.0), it also included a graphical display of an individual patient’s course and supported the generation of reports for general practitioners as well as for other specialists involved in medical care. A major development to promote the system’s acceptance, application and spread was its use within the German MS Register project of the German MS Society (Flachenecker et al. 2005).
MSDS practice MSDS Practice is a modified version of MSDS Clinic with a completely new designed user interface, aimed at specific needs of neurological practitioners. In addition to covering multiple sclerosis, a module for the documentation of patients with Parkinson’s disease has been added. Although further disease modules were planned to unify clinical documentation, sponsoring was not continued to accomplish this goal. As MSDS Clinic, MSDS Practice includes the national MS registry dataset.
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MSDS Practice was developed with the financial support from Schering Deutschland, now Bayer Healthcare. The MSDS project group in Dresden is also responsible for the support of the program.
MSDS 3D As a further development of the MSDS Clinic program, developed by the MSDS project group in Dresden, a multidimensional patient management system (MSDS 3D) was created at the beginning of 2010 which assists neurologists with the execution of complex processes such as treatment management (Schultheiss et al. 2012a; Kratzsch et al. 2009). Within this complete process, all players—patient, MS nurse and neurologist—take part in this system. Furthermore, the software can not only be used to collect patient data and to facilitate their analysis and interpretation, but it can also be used as an interactive system to communicate information to the patient or to get feedback directly by the patient (Kempcke et al. 2012b). The patient interaction takes place either via a touch screen which is part of the patient terminal in the MS center or via email and/or internet connection with a patient’s home computer, which can be controlled using a specific server within the MS center. In the MS center itself, a local MSDS 3D system is found on the local server which controls the dataflow to and from the patient (Fig. 1). As we have recently demonstrated by a detailed survey, MS patients prefer electronic media like the internet (Haase et al. 2012, 2013). The anonymity and the data protection are guaranteed through a complex process which includes an encrypted transfer (Kempcke et al. 2012a). The fundamental idea of the new MSDS 3D interface is an innovation similar to the electronic case report forms (eCRF) with a vertical timeline and corresponding horizontally arranged procedures which are to be executed during the process. These procedures (e.g. documentation of EDSS, patient questionnaire, documentation of infusion) are displayed in the form of procedures boxes (PB). After clicking on the respective procedure box, the corresponding input menu is opened. The individual procedures are executed, as predefined, by either the MS nurse (e.g. patient questionnaire, MSFC) or the treating neurologist (e.g. EDSS, adverse effects). Both can access the MSDS 3D depending upon required authorization. The start screen of MSDS 3D contains the next, last and missed appointments which can be directly assessed by clicking the respective data field (Fig. 2). By clicking on the visits box, additional procedures can be added as boxes (PB) corresponding to the selected visit. If all PBs are green, then the visit is set as approved and can be transferred pseudonymized to the central register
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Fig. 1 Software architecture of MSDS 3D server—Local server with clients, connection with patient terminal, internet, tablet and smart phone— MSDS 3D study server containing pseudonymized data
(e.g. MS register or treatment-specific database). An additional element of MSDS 3D is the generation of doctor’s reports for the corresponding visits which include free text entry as well as text modules that can be used. Not only an entire neurologist’s reports be created but also text blocks can be generated which are then transferred into the individual hospital or practice computer system. The first feedback of patients and physicians was very positive, a detailed analysis is on the way (Ziemssen et al. 2010a).
MSDS 3D: natalizumab module Within the framework of a Biogen Idec Germany supported research project, a module was implemented specifically adapted to treatment with the monoclonal antibody natalizumab which includes all essential process components from diagnostic evaluation (selection of highly active patients) and infusion execution to the necessary follow-up examinations (Ziemssen et al. 2010b). As pilot trial experiment at the MS center in Dresden, this system is currently applied for all natalizumab-treated patients. The sequence of the procedures within the natalizumab module is set. When indication of escalation treatment is given, informed consent of the patient is documented
carefully before the time of the first infusion. Additional necessary procedure boxes include medical history, EDSS and MSFC as well as MRT and paraclinical parameters. As an option, questionnaires such as those concerning quality of life or cognitive testing can be implemented as well. Two additional features, developed by the MS center Dresden specifically with risk management of the progressive multifocal leukoencephalopathy (PML) in mind, have been integrated as an additional incentive for application (Schultheiss et al. 2012b): based on a quiz, the patients are questioned as to their knowledge and understanding of natalizumab at various time points to ensure an excellent knowledge of potential adverse effects and the risk-management plan of natalizumab. This specific questionnaire containing 19 questions can be easily taken using the touch screen of the patient terminal in MS center. The results can be viewed directly by the MS nurse or neurologist. The questionnaire initially serves to provide the natalizumabtreated patient regularly with feedback concerning the efficacy and risk of natalizumab treatment and to also keep the patient’s knowledge of natalizumab up-to-date. The second tool is a pre-infusion checklist which must be completed before each infusion by the patient him/herself and/or with the presence of family asking for potential PML symptoms. This checklist can also be completed using the
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Fig. 2 Start screen of MSDS 3D containing missed, next and last appointments. By mouse click, visit can be quickly loaded
touch screen at the patient terminal. If warning signs of PML come up within the scope of the checklist, then so-called ‘‘red flags’’ will appear which require the treated patient to be immediately taken to the treating physician. If all relevant procedures of the corresponding visit have been completed, then the neurologist will authorize the infusion. The infusion itself is documented by a nurse who will also set the next appointment using the MSDS 3D appointment manager. As an option, the patient can also be reminded of the upcoming appointment by email or text message ahead of time automatically. If the patient does not show up for the agreed upon appointment, then the MSDS 3D will inform the corresponding nurse and physician of this fact. The data involved here are secured using the national and European data protection regulations.
MSDS 3D: fingolimod module for PANGAEA documentation A module for MSDS 3D was also developed for managing the escalation therapeutic fingolimod with the help of the
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pharmaceutical company Novartis, which assists the treating neurologist through the necessary follow-up examinations according to the risk management plan integrated into the MSDS 3D software (Ziemssen et al. 2012b, c). Thanks to the modular structure, neurologists before treatment initiation with fingolimod and at the follow-up visits are structurally guided through the necessary medical investigations to be documented in quarterly intervals. In order to determine the safety and tolerability of fingolimod in daily clinical practice in addition to the detailed clinical studies, a register study has been implemented nationwide (PANGAEA = Post-Authorization Non-interventional German sAfety study of GilEnyA in RRMS patients) (Ziemssen et al. 2012a). Besides the documentation of safety issues, PANGAEA also fulfills quality assurance tasks: Structure and content of the data collection meet the authority requirements concerning fingolimod treatment and reflect the risk management plan of the European Medicines Agency (EMA). The necessary steps to go while on fingolimod treatment such as first dose monitoring, ophthalmological examinations after 3–4 months as well as the regular lab follow-ups are
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Fig. 3 Structure of MSDS 3D PANGAEA module. Module structure is visible in horizontally presented visits. Open modules are yellow, if they are finished, they change to green. Actual screen demonstrates entry screen of EDSS data
presented within the associated PANGAEA MSDS module (Fig. 3). The objective of this non-interventional register study is the prospective collection of long-term safety and pharmacoeconomic data on a total of 4,000 RRMS patients on fingolimod in Germany.
MSDS 3D: module for REGIMS In order to support health care research within the German Competence Network for Multiple Sclerosis (KKNMS), an immunotherapeutic register (REGIMS) is on the way during the second funding period, which aids in early detection of possible severe complications in all MS patients treated by immunotherapy. For further development in the future, cooperation between the Paul Ehrlich Institute and the pharmaceutical industry is planned. Currently, an interface from MSDS 3D to REGIMS is being developed in order to transfer data from the centers into this database.
Conclusion The MSDS program family from the neurological university clinic of Dresden (MSDS Clinic 3.0, MSDS Practice)
can assist neurologists to document their patients with MS in a standardized, high quality way. In the past years, it has been further developed into the patient management software MSDS 3D which allows standardized management and documentation of the patient and serves as a data entry system for various databases. Currently, it is tested at the MS center in Dresden as well as in cooperating MS centers. MSDS 3D is a very promising documentation and management system not only for the academic setting, but also for other MS-specialized centers. It not only makes treatment according to predefined clinical paths for innovative immunotherapeutic drugs possible, but also supports the user with, e.g. patient education, determining of patients active knowledge as well as multidimensional (doctor, nurse, patient) documentation. Thanks to an interface between the local database and the internet, the patient is connected with the system via a personal PC and can, for example, be informed, questioned or reminded of his/her appointments while knowing that data encryption is constantly ensured. The handling of all data gathered using MSDS 3D adheres to the EU guideline 95/46/EC of the European Parliament for the protection of individuals concerning the processing of personal data and the free movement of data as well as the national requirements for data protection (cf. Federal Data Protection Act). Due to
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the implementation of adaptive electronic questionnaires the questioning process is shortened. With the help of interfaces to the in-house database, such as the MS registry, it is possible to bring together important data concerning innovative treatments which cannot be answered by clinical studies. Other language versions such as English and Spanish, which were already integrated into MSDS Clinic, are being under development. The first feedbacks from patients, nurses and doctors are quite positive, corresponding systematic examinations are being created and/or already being implemented (Schultheiss et al. 2012b).
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