@misc{11730, abstract = {{Abstract Background The variety of medical documentation often leads to incompatible data elements that impede data integration between institutions. A common approach to standardize and distribute metadata definitions are ISO/IEC 11179 norm-compliant metadata repositories with top-down standardization. To the best of our knowledge, however, it is not yet common practice to reuse the content of publicly accessible metadata repositories for creation of case report forms or routine documentation. We suggest an alternative concept called pragmatic metadata repository, which enables a community-driven bottom-up approach for agreeing on data collection models. A pragmatic metadata repository collects real-world documentation and considers frequent metadata definitions as high quality with potential for reuse. Methods We implemented a pragmatic metadata repository proof of concept application and filled it with medical forms from the Portal of Medical Data Models. We applied this prototype in two use cases to demonstrate its capabilities for reusing metadata: first, integration into a study editor for the suggestion of data elements and, second, metadata synchronization between two institutions. Moreover, we evaluated the emergence of bottom-up standards in the prototype and two medical data managers assessed their quality for 24 medical concepts. Results The resulting prototype contained 466,569 unique metadata definitions. Integration into the study editor led to a reuse of 1836 items and item groups. During the metadata synchronization, semantic codes of 4608 data elements were transferred. Our evaluation revealed that for less complex medical concepts weak bottom-up standards could be established. However, more diverse disease-related concepts showed no convergence of data elements due to an enormous heterogeneity of metadata. The survey showed fair agreement (Kalpha = 0.50, 95% CI 0.43–0.56) for good item quality of bottom-up standards. Conclusions We demonstrated the feasibility of the pragmatic metadata repository concept for medical documentation. Applications of the prototype in two use cases suggest that it facilitates the reuse of data elements. Our evaluation showed that bottom-up standardization based on a large collection of real-world metadata can yield useful results. The proposed concept shall not replace existing top-down approaches, rather it complements them by showing what is commonly used in the community to guide other researchers.}}, author = {{Hegselmann, Stefan and Storck, Michael and Gessner, Sophia and Neuhaus, Philipp and Varghese, Julian and Bruland, Philipp and Meidt, Alexandra and Mertens, Cornelia and Riepenhausen, Sarah and Baier, Sonja and Stöcker, Benedikt and Henke, Jörg and Schmidt, Carsten Oliver and Dugas, Martin}}, booktitle = {{BMC Medical Informatics and Decision Making}}, issn = {{1472-6947}}, number = {{1}}, publisher = {{Springer Science and Business Media LLC}}, title = {{{Pragmatic MDR: a metadata repository with bottom-up standardization of medical metadata through reuse}}}, doi = {{10.1186/s12911-021-01524-8}}, volume = {{21}}, year = {{2021}}, } @misc{11741, abstract = {{Background Chronic pruritus (CP) is a subjective symptom, and it is necessary to assess its intensity with validated patient-reported outcome tools in order to allow determination of the treatment course. Objectives So far, the itch intensity scales were validated in small cohorts and in single languages. Here, we report the validation of the numerical rating scale, the verbal rating scale and the visual analogue scale for the worst and average pruritus intensity in the last 24h in several languages across Europe and across different pruritic dermatoses. Methods After professional translation, the intensity scales were digitized for use as a tablet computer application. Validation was performed in clinics for Dermatology in Austria, France, Germany, Italy, Poland, Russia, Spain, Switzerland and Turkey. Results A total of 547 patients with contact dermatitis, chronic nodular prurigo, psoriasis vulgaris, lichen planus or cutaneous T-cell lymphoma were included. The intensity scales showed a high level of reproducibility and inter-correlations with each other. The correlation with the Dermatology Life Quality Index was weak to strong in nearly all countries and dermatoses with the exception of France and patients with chronic nodular prurigo, for which no statistically significant correlations were found. Conclusions The numerical rating scale, the verbal rating scale und the visual analogue scales are valid instruments with good reproducibility and internal consistency in German (Germany, Austria, Switzerland), French, Italian, Polish, Russian, Spanish and Turkish for different pruritic dermatoses. VAS worst was the best reproducible and consistent measuring instrument in all countries.}}, author = {{Storck, M. and Sandmann, S. and Bruland, Philipp and Pereira, M.P. and Steinke, S. and Riepe, C. and Soto‐Rey, I. and Garcovich, S. and Augustin, M. and Blome, C. and Bobko, S. and Legat, F.J. and Potekaev, N. and Lvov, A. and Misery, L. and Weger, W. and Reich, A. and Şavk, E. and Streit, M. and Serra‐Baldrich, E. and Szepietowski, J.C. and Dugas, M. and Ständer, S. and Zeidler, C.}}, booktitle = {{Journal of the European Academy of Dermatology and Venereology}}, issn = {{1468-3083}}, number = {{5}}, pages = {{1176--1185}}, publisher = {{Wiley}}, title = {{{Pruritus Intensity Scales across Europe: a prospective validation study}}}, doi = {{10.1111/jdv.17111}}, volume = {{35}}, year = {{2021}}, } @misc{11574, abstract = {{While psychological factors are relevant in many patients with chronic pruritus, not all patients can be offered psychologic, psychosomatic or psychiatric consultation. The aim of this exploratory study was to identify criteria suggestive of psychological factors relevant for the etiology of chronic pruritus and of somatoform pruritus. Routine data from the database of the Center for Chronic Pruritus of the University Hospital Münster were used, including the Neuroderm Questionnaire, Dermatology Life Quality Index and Hospital Anxiety and Depression Scale. chronic pruritus patients (n = 3,391) without a psychiatric diagnosis in their medical history were compared to the 331 chronic pruritus patients with diagnoses of “psychological factors associated with etiology and course of chronic pruritus” (ICD-10:F54) or “somatoform pruritus” (F45.8) confirmed by an expert. The latter reported more pruritus triggers, especially “strain” and “emotional tension” and used more emotional adjectives to describe their pruritus. They reported more often scratching leading to excoriations, higher levels of pruritus, impairment of quality of life, anxiety and depression. These aspects suggest the presence of psychological factors in the etiology of chronic pruritus and somatoform pruritus. Prospective validation, however, needs to be carried out. }}, author = {{Schneider, Gudrun and Grebe, Anna and Bruland, Philipp and Heuft, Gereon and Ständer, Sonja}}, booktitle = {{Acta dermato-venereologica : a journal for clinical and experimental research in the field of dermatology and venereology}}, issn = {{1651-2057}}, number = {{6}}, pages = {{adv00075--7}}, publisher = {{Medical Journals Sweden AB}}, title = {{{Criteria Suggestive of Psychological Components of Itch and Soma­toform Itch: Study of a Large Sample of Patients with Chronic Pruritus}}}, doi = {{10.2340/00015555-3424}}, volume = {{100}}, year = {{2020}}, } @article{11558, abstract = {{Patient Reported Outcomes (PROs) provide essential clinical data for the diagnosis and treatment of patients. Mobile technologies enable rapid and structured collection of PROs with a high usability. MoPat is an electronic PRO system developed at the Münster University that enables patients to complete PROs in multiple languages. This research reports the further development of MoPat and the inclusion of features to document images electronically that will be evaluated in a multi-site clinical research.}}, author = {{Soto-Rey, Iñaki and Hardt, Tobias and Hollenberg, Luca and Bruland, Philipp and Ständer, Sonja and Dugas, Martin and Storck, Michael}}, issn = {{1879-8365}}, journal = {{Stud Health Technol Inform}}, keywords = {{Electronic documentation, Mobile Health, Patient-reported Outcomes.}}, pages = {{1779--1780}}, publisher = {{IOS Press}}, title = {{{Electronic Image Documentation of Patient Reported Outcomes Using Mobile Technologies.}}}, doi = {{10.3233/SHTI190644}}, volume = {{264}}, year = {{2019}}, } @article{11569, author = {{Kock-Schoppenhauer, AK and Bruland, Philipp and Kadioglu, D and Brammen, D and Ulrich, H and Kulbe, K and Duhm-Harbeck, P and Ingenerf, J}}, issn = {{0926-9630}}, journal = {{Stud Health Technol Inform}}, pages = {{1516--1517}}, title = {{{Scientific Challenge in eHealth: MAPPATHON, a Metadata Mapping Challenge.}}}, doi = {{10.3233/SHTI190512}}, volume = {{264}}, year = {{2019}}, } @misc{11735, author = {{Schneider, G. and Grebe, A. and Bruland, Philipp and Heuft, G. and Ständer, S.}}, booktitle = {{British Journal of Dermatology}}, issn = {{1365-2133}}, number = {{6}}, pages = {{1329--1330}}, publisher = {{Oxford University Press (OUP)}}, title = {{{Which patients with chronic pruritus are presented for psychological assessment by their dermatologists? Results from a consecutive sample}}}, doi = {{10.1111/bjd.18259}}, volume = {{181}}, year = {{2019}}, } @misc{11738, author = {{Schneider, G. and Grebe, A. and Bruland, Philipp and Heuft, G. and Ständer, S.}}, booktitle = {{Journal of the European Academy of Dermatology and Venereology}}, issn = {{1468-3083}}, number = {{8}}, publisher = {{Wiley}}, title = {{{Chronic pruritus patients with psychiatric and psychosomatic comorbidity are highly burdened: a longitudinal study}}}, doi = {{10.1111/jdv.15559}}, volume = {{33}}, year = {{2019}}, } @article{11561, abstract = {{CDISC's Operational Data Model (ODM) is a flexible standard for exchanging and archiving metadata and subject clinical data in clinical trials. The Portal of Medical Data Models (MDM-Portal) uses ODM to store more than 15000 medical forms. As not every electronic health system accepts ODM as input format, there is a need for conversion between ODM and other data standards and formats. This research proposes a standardised template-based process to develop ODM converters. So far, ten converters have been developed and integrated in the MDM-Portal following this process and new ones should be included soon. The template, programming utilities and an ODM test suite have been made online available and can be used to easily develop new converters.}}, author = {{Soto-Rey, I and Neuhaus, P and Bruland, Philipp and Geßner, S and Varghese, J and Hegselmann, S and Brix, T and Dugas, M and Storck, M}}, issn = {{1879-8365}}, journal = {{Stud Health Technol Inform}}, keywords = {{CDISC ODM, Semantics, interoperability}}, pages = {{231--235}}, title = {{{Standardising the Development of ODM Converters: The ODMToolBox.}}}, volume = {{247}}, year = {{2018}}, } @article{11577, abstract = {{The establishment of a digital healthcare system is a national and community task. The Federal Ministry of Education and Research in Germany is providing funding for consortia consisting of university hospitals among others participating in the "Medical Informatics Initiative". Exchange of medical data between research institutions necessitates a place where meta information for this data is made accessible. Within these consortia different metadata registry solutions were chosen. To promote interoperability between these solutions, we have examined whether the portal of Medical Data Models is eligible for managing and communicating metadata and relevant information across different data integration centres of the Medical Informatics Initiative and beyond. Apart from the MDM-portal, some ISO 11179-based systems such as Samply.MDR as well as openEHR-based solutions are going to be applyed. In this paper, we have focused on the creation of a mapping model between the CDISC ODM standard and the Samply.MDR import format. In summary, it can be stated that the mapping model is feasible and promote the exchangeability between different metadata registry approaches.}}, author = {{Kock-Schoppenhauer, AK and Ulrich, H and Wagen-Zink, S and Duhm-Harbeck, P and Ingenerf, J and Neuhaus, P and Dugas, M and Bruland, Philipp}}, issn = {{1879-8365}}, journal = {{Studies in health technology and informatics}}, keywords = {{CDISC ODM, MDR, data elements, mapping, metadata registry}}, pages = {{221--225}}, publisher = {{ IOS Press}}, title = {{{Compatibility Between Metadata Standards: Import Pipeline of CDISC ODM to the Samply.MDR.}}}, volume = {{247}}, year = {{2018}}, } @misc{11582, author = {{Steinke, Sabine and Zeidler, Claudia and Riepe, Claudia and Bruland, Philipp and Soto-Rey, Iñaki and Storck, Michael and Augustin, Matthias and Bobko, Svetlana and Garcovich, Simone and Legat, Franz J. and Lvov, Andrey and Misery, Laurent and Osada, Nani and Reich, Adam and Şavk, Ekin and Serra-Baldrich, Esther and Streit, Markus and Szepietowski, Jacek C. and Weger, Wolfgang and Dugas, Martin and Ständer, Sonja}}, booktitle = {{Journal of the American Academy of Dermatology}}, issn = {{1097-6787}}, number = {{3}}, pages = {{457--463.e5}}, publisher = {{Elsevier BV}}, title = {{{Humanistic burden of chronic pruritus in patients with inflammatory dermatoses: Results of the European Academy of Dermatology and Venereology Network on Assessment of Severity and Burden of Pruritus (PruNet) cross-sectional trial}}}, doi = {{10.1016/j.jaad.2018.04.044}}, volume = {{79}}, year = {{2018}}, } @misc{11732, abstract = {{Abstract Introduction: A required step for presenting results of clinical studies is the declaration of participants demographic and baseline characteristics as claimed by the FDAAA 801. The common workflow to accomplish this task is to export the clinical data from the used electronic data capture system and import it into statistical software like SAS software or IBM SPSS. This software requires trained users, who have to implement the analysis individually for each item. These expenditures may become an obstacle for small studies. Objective of this work is to design, implement and evaluate an open source application, called ODM Data Analysis, for the semi-automatic analysis of clinical study data. Methods: The system requires clinical data in the CDISC Operational Data Model format. After uploading the file, its syntax and data type conformity of the collected data is validated. The completeness of the study data is determined and basic statistics, including illustrative charts for each item, are generated. Datasets from four clinical studies have been used to evaluate the application's performance and functionality. Results: The system is implemented as an open source web application (available at https://odmanalysis.uni-muenster.de) and also provided as Docker image which enables an easy distribution and installation on local systems. Study data is only stored in the application as long as the calculations are performed which is compliant with data protection endeavors. Analysis times are below half an hour, even for larger studies with over 6000 subjects. Discussion: Medical experts have ensured the usefulness of this application to grant an overview of their collected study data for monitoring purposes and to generate descriptive statistics without further user interaction. The semi-automatic analysis has its limitations and cannot replace the complex analysis of statisticians, but it can be used as a starting point for their examination and reporting.}}, author = {{Brix, Tobias Johannes and Bruland, Philipp and Sarfraz, Saad and Ernsting, Jan and Neuhaus, Philipp and Storck, Michael and Doods, Justin and Ständer, Sonja and Dugas, Martin}}, booktitle = {{PLOS ONE}}, issn = {{1932-6203}}, number = {{6}}, publisher = {{Public Library of Science (PLoS)}}, title = {{{ODM Data Analysis—A tool for the automatic validation, monitoring and generation of generic descriptive statistics of patient data}}}, doi = {{10.1371/journal.pone.0199242}}, volume = {{13}}, year = {{2018}}, } @misc{11733, abstract = {{Abstract Objective: In the last years, several projects promote the secondary use of routine healthcare data based on electronic health record (EHR) data. In multicenter studies, dedicated pseudonymization services are applied for unified pseudonym handling. Healthcare, clinical research and pseudonymization systems are generally disconnected. Hence, the aim of this research work is to integrate these applications and to evaluate the workflow of clinical research. Methods: We analyzed and identified technical solutions for legislation compliant automatic pseudonym generation and for the integration into EHR as well as electronic data capture (EDC) systems. The Mainzelliste was used as pseudonymization service, which is available as open source solution and compliant with the data privacy concept in Germany. Subject of the integration was the local EHR and an in-house developed EDC system. A time and motion study was conducted to evaluate the effects on the workflow. Results: Integration of EHR, pseudonymization service and EDC systems is technically feasible and leads to a less fragmented usage of all applications. Generated pseudonyms are obtained from the service hosted at a trusted third party and can now be used in the EDC as well as in the EHR system for direct access and re-identification. The evaluation of 90 registration iterations shows that the time for documentation has been significantly reduced in average by 39.6 s (56.3%) from 71 ± 8 s to 31 ± 5 s per registered study patient. Conclusions: By incorporating EHR, EDC and pseudonymization systems, it is now feasible to support multicenter studies and registers out of an integrated system landscape within a hospital. Optimizing the workflow of patient registration for clinical research allows reduction of double data entry and transcription errors as well as a seamless transition from clinical routine to research data collection. Keywords: Data management; Electronic data capture; Health information systems; Pseudonymization; Workflow optimization.}}, author = {{Bruland, Philipp and Doods, Justin and Brix, Tobias and Dugas, Martin and Storck, Michael}}, booktitle = {{International Journal of Medical Informatics}}, issn = {{1386-5056}}, pages = {{103--108}}, publisher = {{Elsevier BV}}, title = {{{Connecting healthcare and clinical research: Workflow optimizations through seamless integration of EHR, pseudonymization services and EDC systems}}}, doi = {{10.1016/j.ijmedinf.2018.09.007}}, volume = {{119}}, year = {{2018}}, } @misc{11739, abstract = {{Background: Chronic pruritus (CP) is a frequently occurring symptom in inflammatory dermatoses, causing a high burden and limitations to health-related quality of life (HRQoL). Objective: The ItchyQoL was developed to assess the impairment to HRQoL in patients with CP. However, it has only been validated in English and German. Here, we report the validation in several languages across Europe. Methods: After professional translation, the versions of ItchyQoL were digitized for use as a tablet application. Validation was performed in clinics for dermatology in Austria, France, Germany, Italy, Poland, Russia, Spain, Switzerland and Turkey. Results: Five hundred and thirty-five patients with either contact dermatitis, chronic prurigo - nodular type, psoriasis vulgaris, lichen planus or mycosis fungoides/Sézary syndrome and with CP ≥ 3 on the numerical rating scale were included. ItchyQoL showed a high level of consistency (Cronbach's-α, all: 0.95) and test-retest reliability (intraclass correlation: 0.91). It strongly correlated with the Dermatology Life Quality Index (r = 0.72, P < 0.001) and moderately correlated with itch intensity scales in the study population (visual analogue scale r = 0.46; numerical rating scale r = 0.51; verbal rating scale r = 0.51, for all: P < 0.001). Conclusion: ItchyQoL is now also validated in French, Italian, Polish, Russian, Spanish and Turkish and can be used in clinical trials in countries speaking these languages.}}, author = {{Zeidler, C. and Steinke, S. and Riepe, C. and Bruland, Philipp and Soto‐Rey, I. and Storck, M. and Garcovich, S. and Blome, C. and Bobko, S. and Legat, F.J. and Potekaev, N. and Lvov, A. and Misery, L. and Weger, W. and Reich, A. and Şavk, E. and Streit, M. and Serra‐Baldrich, E. and Szepietowski, J.C. and Yosipovitch, G. and Chen, S.C. and Dugas, M. and Ständer, S.}}, booktitle = {{Journal of the European Academy of Dermatology and Venereology}}, issn = {{1468-3083}}, number = {{2}}, pages = {{391--397}}, publisher = {{Wiley}}, title = {{{Cross‐European validation of the ItchyQoL in pruritic dermatoses}}}, doi = {{10.1111/jdv.15225}}, volume = {{33}}, year = {{2018}}, } @misc{11740, abstract = {{Background Patient-reported outcomes (PROs) are information provided directly by patients that helps in improving patient diagnosis and treatment. Validated translations of PROs can be used to treat international patients. Electronic systems and especially mobile devices provide a great opportunity for their collection; however, these systems are normally study-oriented and therefore single language, not scalable, and not interoperable. Objectives This article reports the development of a multicenter, multilingual, and interoperable electronic PRO (ePRO) system and evaluates its user satisfaction in an international clinical study. Methods The ePRO named “MoPat2” was developed using Java 8 and jQuery Mobile 1.4.5. The system was evaluated in the context of the European dermatology project “European Network on Assessment of Severity and Burden of Pruritus”(PruNet), which aimed to unify the assessment of itch in routine dermatological care in Europe. Twenty-six clinicians and 468 patients from 8 European clinical centers were asked to complete a user satisfaction questionnaire regarding the use of MoPat2 with a tablet personal computer. The results were then analyzed and correlated with the age, gender, and language of the respondents. Results MoPat2 was enhanced with multilingual capabilities and is now able to conduct surveys in several languages, as well as store and display the results in the local language. The interviewed clinicians rated the system with an average score of 2.0 (“good”) in a 1 to 5 Likert scale. Note that 93.9% of the patients (439 of 468) reported having got on well using the system and 88.9% (416 of 456) would be willing to further use it. The age of the patients not willing to further use MoPat2 was, in average, considerably higher than the age of patients willing to use the system. Conclusions This study represents the first use of an ePRO system for the collection of multilingual PROs in an international, multicenter setting. MoPat2 has been evaluated by both clinicians and patients in the context of a European dermatological study, resulting in a high user satisfaction. The system will be further developed to include new features such as patient follow-ups outside of the clinical setting.}}, author = {{Soto-Rey, I. and Rehr, M. and Bruland, Philipp and Zeidler, C. and Riepe, C. and Steinke, S. and Ständer, S. and Dugas, M. and Storck, M.}}, booktitle = {{Methods of Information in Medicine}}, issn = {{2511-705X}}, keywords = {{patient-reported outcome measures, multilingualism, mobile health}}, number = {{S 02}}, pages = {{e107--e114}}, publisher = {{Georg Thieme Verlag KG}}, title = {{{Electronic Collection of Multilingual Patient-Reported Outcomes across Europe}}}, doi = {{10.1055/s-0038-1675397}}, volume = {{57}}, year = {{2018}}, } @misc{11746, abstract = {{Objectives: Integrating Electronic Health Record (EHR) systems into the field of clinical trials still contains several challenges and obstacles. Heterogeneous standards and specifications are used to represent healthcare and clinical trial information. Therefore, this work investigates the mapping and data interoperability between healthcare and research standards: EN13606 used for the EHRs and the Clinical Data Interchange Standards Consortium Operational Data Model (CDISC ODM) used for clinical research. Methods: Based on the specifications of CDISC ODM 1.3.2 and EN13606, a mapping between the structure and components of both standards has been performed. Archetype Definition Language (ADL) forms built with the EN13606 editor were transformed to ODM XML and reviewed. As a proof of concept, clinical sample data has been transformed into ODM and imported into an electronic data capture system. Reverse transformation from ODM to ADL has also been performed and finally reviewed concerning map-ability. Results: The mapping between EN13606 and CDISC ODM shows the similarities and differences between the components and overall record structure of the two standards. An EN13606 archetype corresponds with a group of items within CDISC ODM. Transformations of element names, descriptions, different languages, datatypes, cardinality, optionality, units, value range and terminology codes are possible from EN13606 to CDISC ODM and vice versa. Conclusion: It is feasible to map data elements between EN13606 and CDISC ODM and transformation of forms between ADL and ODM XML format is possible with only minor limitations. EN13606 can accommodate clinical information in a more structured manner with more constraints, whereas CDISC ODM is more suitable and specific for clinical trials and studies. It is feasible to transform EHR data in the EN13606 form to ODM to transfer it into research database. The attempt to use EN13606 to build a study protocol (that was already built with CDISC ODM) also suggests the possibility of using EN13606 standard in place of CDISC ODM if needed to avoid transformations.}}, author = {{Tapuria, Archana and Bruland, Philipp and Delaney, Brendan and Kalra, Dipak and Curcin, Vasa}}, booktitle = {{Digital health}}, issn = {{2055-2076}}, keywords = {{EN13606, Operational data model, clinical archetypes, electronic health records, interoperability.}}, publisher = {{SAGE Publications}}, title = {{{Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data}}}, doi = {{10.1177/2055207618777676}}, volume = {{4}}, year = {{2018}}, } @article{11560, abstract = {{To address current key problems of medical documentation: lack of transparency, overwhelming amount of medical contents to be documented and missing interoperability, the Portal of Medical Data Models (http://medical-data-models.org/) was established in 2012. Constantly evolving, four years later, the portal displays more than 8900 medical data models with more than 250000 items, of which 84 % have been semantically annotated with UMLS codes to support interoperability. Giving an update on new functions and contents of the portal, two additional export formats have been implemented, allowing the reuse of forms such as HL7's framework Fast Health Interoperability Resources (FHIR) Questionnaires, as well as the OpenDataKit format. Future projects include the implementation of an ODMtoOpenClinica converter, as well as supporting the reuse of forms with Apple's ResearchKit and Android's ResearchStack.}}, author = {{Geßner, S and Neuhaus, P and Varghese, J and Bruland, Philipp and Meidt, A and Soto-Rey, I and Storck, M and Doods, J and Dugas, M}}, issn = {{0926-9630}}, journal = {{Stud Health Technol Inform}}, keywords = {{Clinical Trial, Semantics, Surveys and Questionnaires}}, pages = {{858--862}}, publisher = {{ IOS Press}}, title = {{{The Portal of Medical Data Models: Where Have We Been and Where Are We Going?}}}, volume = {{245}}, year = {{2017}}, } @article{11576, abstract = {{Data dictionaries provide structural meta-information about data definitions in health information technology (HIT) systems. In this regard, reusing healthcare data for secondary purposes offers several advantages (e.g. reduce documentation times or increased data quality). Prerequisites for data reuse are its quality, availability and identical meaning of data. In diverse projects, research data warehouses serve as core components between heterogeneous clinical databases and various research applications. Given the complexity (high number of data elements) and dynamics (regular updates) of electronic health record (EHR) data structures, we propose a clinical metadata warehouse (CMDW) based on a metadata registry standard. Metadata of two large hospitals were automatically inserted into two CMDWs containing 16,230 forms and 310,519 data elements. Automatic updates of metadata are possible as well as semantic annotations. A CMDW allows metadata discovery, data quality assessment and similarity analyses. Common data models for distributed research networks can be established based on similarity analyses.}}, author = {{Bruland, Philipp and Doods, J and Storck, M and Dugas, M}}, issn = {{1879-8365}}, journal = {{Studies in health technology and informatics}}, keywords = {{Information Systems, Metadata, Semantics}}, pages = {{313--317}}, title = {{{What Information Does Your EHR Contain? Automatic Generation of a Clinical Metadata Warehouse (CMDW) to Support Identification and Data Access Within Distributed Clinical Research Networks.}}}, volume = {{245}}, year = {{2017}}, } @misc{11585, author = {{Steinke, Sabine and Bruland, Philipp and Blome, Catherine Sharie and Osada, N. and Dugas, M. and Fritz, F. and Augustin, M. and Ständer, S.}}, booktitle = {{British Journal of Dermatology}}, issn = {{0007-0963}}, number = {{2}}, pages = {{363--370}}, publisher = {{Oxford University Press (OUP)}}, title = {{{Chronic pruritus: evaluation of patient needs and treatment goals with a special regard to differences according to pruritus classification and sex}}}, doi = {{10.1111/bjd.14910}}, volume = {{176}}, year = {{2017}}, } @misc{11587, author = {{Bruland, Philipp and Dugas, Martin}}, booktitle = {{BMC Medical Informatics and Decision Making}}, issn = {{1472-6947}}, number = {{1}}, publisher = {{Springer Science and Business Media LLC}}, title = {{{S2O – A software tool for integrating research data from general purpose statistic software into electronic data capture systems}}}, doi = {{10.1186/s12911-016-0402-4}}, volume = {{17}}, year = {{2017}}, } @article{11590, abstract = {{Reading centers provide centralized high-quality diagnostics in ophthalmic clinical trials. Since ophthalmic images are captured in electronic format at peripheral clinics, an integrated workflow for image transfer and creation of structured reports is needed, including quality assurance. The image portal and the study database are separate components. We assessed whether this integration is feasible with trial-related IT standards and built a prototype system as a proof-of-concept. CDISC ODM and OAuth authentication were used to integrate the image portal with x4T-EDC, facilitating automatic data transfer and single sign-on.}}, author = {{Bruland, Philipp and Kathöfer, Ulrike and Treder, Maximilian and Eter, Nicole and Dugas, Martin}}, issn = {{1879-8365}}, journal = {{Studies in health technology and informatics}}, keywords = {{Electronic Data Capture, Reading Center, System Integration}}, pages = {{1254}}, publisher = {{IOS Press}}, title = {{{Integrating x4T-EDC into an Image-Portal to Establish an Ophthalmic Reading Center.}}}, volume = {{245}}, year = {{2017}}, } @misc{11734, abstract = {{Patient care for those affected by chronic pruritus is remarkably complex due to its high prevalence and multifactorial nature. It requires a comprehensive assessment of the patient’s medical history, extensive diagnostic procedures, and long treatment duration, including management of possible accompanying disorders such as sleep disturbances and mental distress. It is important to prioritize patient’s needs when developing a therapeutic treatment plan. Standardized questionnaires and scales should be used to better analyze the patient history, quality of life, symptom intensity, and course of treatment. These can be distributed via digital platforms, allowing for more effective communication between the treating agents and gathering of large volumes of data in central databases. In today’s health care system, it is essential for physicians with itch-related specializations and specialized itch centers to cooperate. It is thus crucial to focus efforts on the further development of specialized treatment centers and training courses for medical practitioners. There are, however, various regulatory and economic barriers to overcome in the modern health care system before patients with chronic pruritus can be offered the best possible care. Accordingly, health care authorities should be made aware of the difficulties associated with the management of chronic pruritus and of the high individual and societal burden it represents.}}, author = {{Pereira, Manuel P. and Steinke, Sabine and Bruland, Philipp and Ständer, Hartmut F. and Dugas, Martin and Augustin, Matthias and Ständer, Sonja}}, booktitle = {{Itch}}, issn = {{2380-5048}}, number = {{2}}, pages = {{e6--e6}}, publisher = {{Ovid Technologies (Wolters Kluwer Health)}}, title = {{{Management of chronic pruritus: from the dermatological office to the specialized itch center: a review}}}, doi = {{10.1097/itx.0000000000000006}}, volume = {{2}}, year = {{2017}}, } @misc{11743, abstract = {{Background: The term prurigo has been used for many decades in dermatology without clear definition, and currently used terminology of prurigo is inconsistent and confusing. Especially, itch-related prurigo remains unexplored regarding the epidemiology, clinical profile, natural course, underlying causes, available treatments and economic burden, although burdensome and difficult to treat. Objective: To address these issues, the multicentre European Prurigo Project (EPP) was designed to increase knowledge on chronic prurigo (CPG). In the first step, European experts of the EADV Task Force Pruritus (TFP) aimed to achieve a consensus on the definition, classification and terminology of CPG. Additionally, procedures of the cross-sectional EPP were discussed and agreed upon. Methods: Discussions and surveys between members of the TFP served as basis for a consensus conference. Using the Delphi method, consensus was defined as an agreement ≥75% among the present members. Results: Twenty-four members of the TFP participated in the consensus conference. Experts consented that CPG should be used as an umbrella term for the range of clinical manifestations (e.g. papular, nodular, plaque or umbilicated types). CPG is considered a distinct disease defined by the presence of chronic pruritus for ≥6 weeks, history and/or signs of repeated scratching and multiple localized/generalized pruriginous skin lesions (whitish or pink papules, nodules and/or plaques). CPG occurs due to a neuronal sensitization to itch and the development of an itch-scratch cycle. Conclusion: This new definition and terminology of CPG should be implemented in dermatology to harmonize communication in the clinical routine, clinical trials and scientific literature. Acute/subacute forms of prurigo are separated entities, which need to be differentiated from CPG and will be discussed in a next step. In the near future, the cross-sectional EPP will provide relevant clinical data on various aspects of CPG leading to new directions in the scientific investigation of CGP.}}, author = {{Pereira, M.P. and Steinke, S. and Zeidler, C. and Forner, C. and Riepe, C. and Augustin, M. and Bobko, S. and Dalgard, F. and Elberling, J. and Garcovich, S. and Gieler, U. and Gonçalo, M. and Halvorsen, J. A. and Leslie, T.A. and Metz, M. and Reich, A. and Şavk, E. and Schneider, G. and Serra‐Baldrich, E. and Ständer, H.F. and Streit, M. and Wallengren, J. and Weller, K. and Wollenberg, A. and Bruland, Philipp and Soto‐Rey, I. and Storck, M. and Dugas, M. and Weisshaar, E. and Szepietowski, J.C. and Legat, F.J. and Ständer, S.}}, booktitle = {{Journal of the European Academy of Dermatology and Venereology}}, issn = {{1468-3083}}, number = {{7}}, pages = {{1059--1065}}, publisher = {{Wiley}}, title = {{{European academy of dermatology and venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo}}}, doi = {{10.1111/jdv.14570}}, volume = {{32}}, year = {{2017}}, } @misc{11566, abstract = {{Introduction : Information systems are a key success factor for medical research and healthcare. Currently, most of these systems apply heterogeneous and proprietary data models, which impede data exchange and integrated data analysis for scientific purposes. Due to the complexity of medical terminology, the overall number of medical data models is very high. At present, the vast majority of these models are not available to the scientific community. The objective of the Portal of Medical Data Models (MDM, https://medical-data-models.org ) is to foster sharing of medical data models.}}, author = {{Dugas, Martin and Neuhaus, Philipp and Meidt, Alexandra and Doods, Justin and Storck, Michael and Bruland, Philipp and Varghese, Julian}}, booktitle = {{Database}}, issn = {{1758-0463}}, publisher = {{Oxford University Press (OUP)}}, title = {{{Portal of medical data models: information infrastructure for medical research and healthcare}}}, doi = {{10.1093/database/bav121}}, volume = {{2016}}, year = {{2016}}, } @misc{11737, abstract = {{Abstract Background: Chronic kidney disease (CKD) is strongly associated with coronary artery disease (CAD). We established a prospective observational nationwide multicenter registry to evaluate current treatment and outcomes in patients with both CKD and angiographically documented CAD. Methods: In 32 cardiological centers 3,352 CAD patients with ≥50% stenosis in at least one coronary artery were enrolled and classified according to their estimated glomerular filtration rate and proteinuria into one of five stages of CKD or as a control group. Results: 2,723 (81.2%) consecutively enrolled patients suffered from CKD. Compared to controls, CKD patients had a higher prevalence of diabetes, hypertension, peripheral artery diseases, heart failure, and valvular heart disease (each p<0.001). Myocardial infarctions (p = 0.02), coronary bypass grafting, valve replacements and pacemaker implantations had been recorded more frequently (each p<0.001). With advanced CKD, the number of diseased coronary vessels and the proportion of patients with reduced left ventricular ejection fraction (LVEF) increased significantly (both p<0.001). Percutaneous coronary interventions were performed less frequently (p<0.001) while coronary bypass grafting was recommended more often (p = 0.04) with advanced CKD. With regard to standard drugs in CAD treatment, prescriptions were higher in our registry than in previous reports, but beta-blockers (p = 0.008), and angiotensin-converting-enzyme inhibitors and/or angiotensin-receptor blockers (p<0.001) were given less often in higher CKD stages. In contrast, in the subgroup of patients with moderately to severely reduced LVEF the prescription rates did not differ between CKD stages. In-hospital mortality increased stepwise with each CKD stage (p = 0.02). Conclusions: In line with other studies comprising CKD cohorts, patients' morbidity and in-hospital mortality increased with the degree of renal impairment. Although cardiologists' drug prescription rates in CAD-REF were higher than in previous studies, they were still lower especially in advanced CKD stages compared to cohorts treated by nephrologists.}}, author = {{Reinecke, Holger and Breithardt, Günter and Engelbertz, Christiane and Schmieder, Roland E. and Fobker, Manfred and Pinnschmidt, Hans O. and Schmitz, Boris and Bruland, Philipp and Wegscheider, Karl and Pavenstädt, Hermann and Brand, Eva}}, booktitle = {{PLOS ONE}}, issn = {{1932-6203}}, number = {{2}}, publisher = {{Public Library of Science (PLoS)}}, title = {{{Baseline Characteristics and Prescription Patterns of Standard Drugs in Patients with Angiographically Determined Coronary Artery Disease and Renal Failure (CAD-REF Registry)}}}, doi = {{10.1371/journal.pone.0148057}}, volume = {{11}}, year = {{2016}}, } @misc{11744, abstract = {{Chronischer Pruritus ist ein hochprävalentes und multifaktorielles Symptom, das hohe Anforderungen an die Diagnostik, Therapie und Beachtung von Begleiterscheinungen (reduzierte Lebensqualität, Schlafstörungen, psychische Faktoren) stellt. Die Versorgung der Patienten ist daher komplex und bedarf auch einer Betrachtung individueller Therapieziele. Neben der Pruritusfreiheit scheinen insbesondere eine Aufklärung der Ursachen sowie ein vertrauensvolles Arzt-Patienten-Verhältnis relevant. Um diesem gerecht zu werden, empfiehlt sich der gezielte Einsatz von Fragebögen zur strukturierten Erhebung von Anamnese, Pruritusintensität, Lebensqualität und Therapieverlauf in der Klinik und Praxis. Dennoch bestehen weiterhin viele administrative und ökonomische Hürden im Gesundheitssystem, um Patienten mit chronischem Pruritus die bestmögliche oder durch Leitlinien empfohlene Versorgung anzubieten. Der Ausbau spezialisierter Zentren und die Schulung von Behandlern sind daher dringend erforderlich.}}, author = {{Ständer, S. and Ständer, H. F. and Steinke, S. and Bruland, Philipp and Dugas, M. and Augustin, M.}}, booktitle = {{Der Hautarzt}}, issn = {{1432-1173}}, number = {{8}}, pages = {{640--647}}, publisher = {{Springer Science and Business Media LLC}}, title = {{{Chronischer Pruritus}}}, doi = {{10.1007/s00105-016-3829-8}}, volume = {{67}}, year = {{2016}}, } @misc{11745, abstract = {{Background: Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems. Methods: Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. Results: The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Conclusions: Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.}}, author = {{Bruland, Philipp and McGilchrist, Mark and Zapletal, Eric and Acosta, Dionisio and Proeve, Johann and Askin, Scott and Ganslandt, Thomas and Doods, Justin and Dugas, Martin}}, booktitle = {{BMC Medical Research Methodology}}, issn = {{1471-2288}}, keywords = {{Clinical trials, Common data elements, Data quality, Electronic health records, Metadata, Secondary use}}, number = {{1}}, publisher = {{Springer Science and Business Media LLC}}, title = {{{Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting}}}, doi = {{10.1186/s12874-016-0259-3}}, volume = {{16}}, year = {{2016}}, } @article{11572, abstract = {{The complex nature and difficult-to-establish aetiology of chronic pruritus (CP) makes it challenging to provide medical care for patients with CP. This challenge can only be met with a multidisciplinary approach. The first multidisciplinary Itch Centre in Germany was established at the University of Münster in 2002 to meet the needs of this patient population. More than 2,500 outpatients and 400 inpatients are diagnosed and receive treatment each year. To ensure evidence-based medical care, an electronic system for medical documentation and patient-reported outcomes was established. Automated data transfer to a research database enables comprehensive data analysis. Our translational research has characterized peripheral and central itch mechanisms, provided novel clustering of CP patients, and identified novel target-specific therapies (e.g. neurokinin 1 receptor-antagonist). The multidisciplinary approach, combined with basic, clinical and translational research, enables comprehensive medical care of patients as well as implementation of high-quality experimental and clinical studies. }}, author = {{Ständer, Sonja and Pogatzki-Zahn, Esther and Stumpf, Astrid and Fritz, Fleur and Pfleiderer, Bettina and Ritzkat, Anika and Bruland, Philipp and Lotts, Tobias and Müller-Tidow, Carsten and Heuft, Gereon and Pavenstädt, Hermann-Joseph and Schneider, Gudrun and Van Aken, Hugo and Heindel, Walter and Wiendl, Heinz and Dugas, Martin and Luger, Thomas A.}}, issn = {{0001-5555}}, journal = {{ Acta dermato-venereologica : a journal for clinical and experimental research in the field of dermatology and venereology}}, number = {{3}}, pages = {{266--271}}, title = {{{Facing the challenges of chronic pruritus: a report from a multi-disciplinary medical itch centre in Germany.}}}, doi = {{10.2340/00015555-1949 }}, volume = {{95}}, year = {{2015}}, } @article{11575, abstract = {{In the treatment of chronic pruritus-related, scratch-induced skin lesions the categorization, counting and temporal comparison are common methodologies. The observation requires a good memory and expertise in this field to gain comparable findings for this time-consuming process. Digital image processing aims at supporting such manual detections. The objective is to develop a software tool for automatic image detection and comparison. The new photographic setting implies the usage of markers to derive the brightness and size of lesions. MATLAB has been used for the software development. The newly defined setting allows taking standardized images of pruritus-associated cutaneous lesions for detection and comparison. The tool named PIACS (Prurigo Image Analyzing and Comparing System) allows automatically detecting, categorizing and comparing lesions based on digital images.}}, author = {{Bruland, Philipp and Hänse, Waldemar and Schedel, Fiona and Ständer, Sonja and Fritz, Fleur}}, issn = {{1879-8365}}, journal = {{Studies in health technology and informatics}}, pages = {{1042}}, publisher = {{IOS Press}}, title = {{{PIACS: A System for the Automatic Detection, Categorization and Comparison of Scratch-Related Skin Lesions in Dermatology.}}}, volume = {{216}}, year = {{2015}}, } @misc{11583, abstract = {{Background: It is unknown if health-related quality of life (HRQoL) differs between diseases associated with chronic pruritus (CP). Objective: To analyze HRQoL in relation to age, gender, skin lesions (primary vs. scratch-induced secondary) and itch intensity. Methods: Consecutive patients of our itch clinic were assessed with the Dermatology Life Quality Index (DLQI) and visual analogue scale (VAS). Results: In 510 CP patients (282 females; median age, 61.4 years), DLQI scores and VAS values were highly correlated, irrespective of the type of skin lesion. Overall, women had a lower HRQoL compared to men (females: 10.7 ± 6.7, males: 8.9 ± 6.7), but female gender was only associated with worse quality of life in patients <65 years old. Conclusion: HRQoL impairment in CP is highly influenced by pruritus intensity but not to the visible skin lesion or underlying cause. With limitations to item bias, DLQI is a suitable instrument for estimating quality of life impairment by CP.}}, author = {{Warlich, Benjamin and Fritz, Fleur and Osada, Nani and Bruland, Philipp and Stumpf, Astrid and Schneider, Gudrun and Dugas, Martin and Pfleiderer, Bettina and Ständer, Sonja}}, booktitle = {{Dermatology}}, issn = {{1421-9832}}, number = {{3}}, pages = {{253--259}}, publisher = {{S. Karger AG}}, title = {{{Health-Related Quality of Life in Chronic Pruritus: An Analysis Related to Disease Etiology, Clinical Skin Conditions and Itch Intensity}}}, doi = {{10.1159/000437206}}, volume = {{231}}, year = {{2015}}, } @misc{11584, abstract = {{Background Chronic pruritus is a frequently occurring symptom of various dermatoses that causes a high burden and impaired quality of life. An effective anti pruritic therapy is important for the patient, but its effectiveness is difficult to evaluate. Diverse methods and interpretations of pruritic metrics are utilized in clinical trials and the daily clinical practice in different countries, resulting in difficulties comparing collected data. Methods We founded a European Network on Assessment of Severity and Burden of Pruritus (PruNet) that is supported by the EADV. PruNet consists of 28 experts from 15 EU countries (21 dermatologists, 5 medical informaticists, 2 psychologists) and aims to unify the assessment of itch in routine dermatological care. Following a preliminary survey, a consensus conference was held in order to agree upon the prioritization of patient-reported outcome tools. Results Through utilizing the Delphi method, it was agreed that tools for measuring itch intensity (ex. the visual analogue scale) and quality of life (ex. ItchyQoL) are of primary importance and should urgently be foremost validated. Conclusion The validation and harmonization of standards are needed for the improvement of quality care for patients suffering from pruritic dermatoses. This summer, the first validation studies in several EADV member countries already began. }}, author = {{Ständer, S. and Zeidler, C. and Riepe, C. and Steinke, S. and Fritz, F. and Bruland, Philipp and Soto‐Rey, I. and Storck, M. and Agner, T. and Augustin, M. and Blome, C. and Dalgard, F. and Evers, A.W.M. and Garcovich, S. and Gonçalo, M. and Lambert, J. and Legat, F.J. and Leslie, T. and Misery, L. and Raap, U. and Reich, A. and Şavk, E. and Streit, M. and Serra‐Baldrich, E. and Szepietowski, J. and Wallengren, J. and Weisshaar, E. and Dugas, M.}}, booktitle = {{Journal of the European Academy of Dermatology and Venereology}}, issn = {{1468-3083}}, number = {{7}}, pages = {{1144--1147}}, publisher = {{Wiley-Blackwell }}, title = {{{European EADV network on assessment of severity and burden of Pruritus (PruNet): first meeting on outcome tools}}}, doi = {{10.1111/jdv.13296}}, volume = {{30}}, year = {{2015}}, } @misc{11581, author = {{Stumpf, A. and Ständer, S. and Warlich, B. and Fritz, F. and Bruland, Philipp and Pfleiderer, B. and Heuft, G. and Schneider, G.}}, booktitle = {{The British journal of dermatology : BJD }}, issn = {{1365-2133 }}, number = {{5}}, pages = {{1323--1328}}, publisher = {{Oxford University Press (OUP)}}, title = {{{Relations between the characteristics and psychological comorbidities of chronic pruritus differ between men and women: women are more anxious than men}}}, doi = {{10.1111/bjd.13492}}, volume = {{172}}, year = {{2014}}, } @article{11573, abstract = {{Planning case report forms for data capture in clinical trials is a labor-insensitive and not formalized process. These CRFs are often neither standardized nor using defined data elements. Metadata registries as the NCI caDSR provide the capability to create forms based on common data elements. However, an exchange of these forms into clinical trial management systems through a standardized format like CDISC ODM is currently not offered. Thus, our objectives were to develop a mapping model between NCI forms and ODM. We analyzed 3012 NCI forms and included common data elements regarding their frequency and uniqueness. In this paper, we have created a mapping model between both formats and identified limitations in the conversion process: Semantic codes requested from the caDSR registry did not allow a proper mapping to ODM items and information like the number of module repetitions got lost. Summarized, it can be stated that our mapping model is feasible. However, mapping of semantic concepts in ODM needs to be specified more precisely.}}, author = {{Bruland, Philipp and Breil, Bernhard and Fritz, Fleur and Dugas, Martin}}, issn = {{1879-8365}}, journal = {{Studies in health technology and informatics}}, pages = {{564--568}}, publisher = {{IOS Press}}, title = {{{Interoperability in clinical research: from metadata registries to semantically annotated CDISC ODM.}}}, volume = {{180}}, year = {{2012}}, } @misc{11589, abstract = {{Background: Semantic interoperability between routine healthcare and clinical research is an unsolved issue, as information systems in the healthcare domain still use proprietary and site-specific data models. However, information exchange and data harmonization are essential for physicians and scientists if they want to collect and analyze data from different hospitals in order to build up registries and perform multicenter clinical trials. Consequently, there is a need for a standardized metadata exchange based on common data models. Currently this is mainly done by informatics experts instead of medical experts.Objectives: We propose to enable physicians to exchange, rate, comment and discuss their own medical data models in a collaborative web-based repository of medical forms in a standardized format.Methods: Based on a comprehensive requirement analysis, a web-based portal for medical data models was specified. In this context, a data model is the technical specification (attributes, data types, value lists) of a medical form without any layout information. The CDISC Operational Data Model (ODM) was chosen as the appropriate format for the standardized representation of data models. The system was implemented with Ruby on Rails and applies web 2.0 technologies to provide a community based solution. Forms from different source systems – both routine care and clinical research – were converted into ODM format and uploaded into the portal.Results: A portal for medical data models based on ODM-files was implemented (http://www.medical-data-models.org). Physicians are able to upload, comment, rate and download medical data models. More than 250 forms with approximately 8000 items are provided in different views (overview and detailed presentation) and in multiple languages. For instance, the portal contains forms from clinical and research information systems.Conclusion: The portal provides a system-independent repository for multilingual data models in ODM format which can be used by physicians. It serves as a platform for discussion and enables the exchange of multilingual medical data models in a standardized way.}}, author = {{Kenneweg, J. and Fritz, F. and Bruland, Philipp and Doods, D. and Trinczek, B. and Dugas, M. and Breil, B.}}, booktitle = {{ Applied clinical informatics : ACI ; official eJournal of IMIA and AMDIS}}, issn = {{1869-0327}}, number = {{03}}, pages = {{276--289}}, publisher = {{Schattauer}}, title = {{{Multilingual Medical Data Models in ODM Format}}}, doi = {{10.4338/aci-2012-03-ra-0011}}, volume = {{03}}, year = {{2012}}, } @misc{11742, abstract = {{With a prevalence of 20%, chronic pruritus is a symptom of many diseases with major impact on healthcare costs. The lack of specific therapeutic measures makes the development of new drugs and their testing in clinical trials urgent. It is not possible to measure pruritus in an objective way. For these reasons, it is necessary to have a series of standardized measures to characterize pruritus in a reliable way. Intensity scales such as the visual analog scale (VAS) are most frequently used to document the course of the symptoms. However, for assessing pruritus intensity, VAS is not an optimal instrument, although it cannot be dispensed with. The VAS should be combined with other scales in clinical studies in order to internally test the consistency of data. Other instruments for assessing intensity and course of pruritus are in the process of development. Presently scratch activity and scratch-associated lesions can be documented in a descriptive fashion. There are some studies that have employed devices to document scratch activity; however, methodological studies are not yet available. The patient-benefit index is an indispensable tool in clinical trials. A questionnaire for gathering data on the history and some pruritus-specific parameters has been developed and published. Questionnaires on patient quality of life, anxiety and depression are helpful in obtaining data on other cost-relevant parameters. A questionnaire on the quality of life, for instance, can provide important help in the assessment of the burden of the disease. The results of these questionnaires can be correlated with data on pruritus intensity scales. The relevant questionnaires have been partially digitalized so that they are available immediately as part of patient care. Additional methodological developments and studies are required in order to define a robust set of instruments for measuring pruritus in daily practice and in clinical studies.}}, author = {{Ständer, S. and Blome, C. and Breil, B. and Bruland, Philipp and Darsow, U. and Dugas, M. and Evers, A. and Fritz, F. and Metz, M. and Phan, N.Q. and Raap, U. and Reich, A. and Schneider, G. and Steinke, S. and Szepietowski, J. and Weisshaar, E. and Augustin, M.}}, booktitle = {{Der Hautarzt}}, issn = {{1432-1173}}, number = {{7}}, pages = {{521--531}}, publisher = {{Springer Science and Business Media LLC}}, title = {{{Erfassung von Pruritus – aktuelle Standards und Implikationen für die Praxis}}}, doi = {{10.1007/s00105-011-2318-3}}, volume = {{63}}, year = {{2012}}, }