@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{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}},
}
@misc{11588,
author = {{Bruland, Philipp and Forster, Christian and Breil, Bernhard and Ständer, Sonja and Dugas, Martin and Fritz, Fleur}},
booktitle = {{International Journal of Medical Informatics}},
issn = {{1872-8243}},
number = {{12}},
pages = {{915--928}},
publisher = {{Elsevier BV}},
title = {{{Does single-source create an added value? Evaluating the impact of introducing x4T into the clinical routine on workflow modifications, data quality and cost–benefit}}},
doi = {{10.1016/j.ijmedinf.2014.08.007}},
volume = {{83}},
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}},
}