Philipp Bruland

Health-Related Quality of Life in Chronic Pruritus: An Analysis Related to Disease Etiology, Clinical Skin Conditions and Itch Intensity.

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.

Relations between the characteristics and psychological comorbidities of chronic pruritus differ between men and women: women are more anxious than men†

Although sex and gender are becoming more important in diagnostics and therapy, there is still little knowledge about sex‐specific differences in chronic pruritus (CP).

European EADV network on assessment of severity and burden of Pruritus (PruNet): first meeting on outcome tools

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.

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

OBJECTIVES The first objective of this study is to evaluate the impact of integrating a single-source system into the routine patient care documentation workflow with respect to process modifications, data quality and execution times in patient care as well as research documentation. The second one is to evaluate whether it is cost-efficient using a single-source system in terms of achieved savings in documentation expenditures. METHODS We analyzed the documentation workflow of routine patient care and research documentation in the medical field of pruritus to identify redundant and error-prone process steps. Based on this, we established a novel documentation workflow including the x4T (exchange for Trials) system to connect hospital information systems with electronic data capture systems for the exchange of study data. To evaluate the workflow modifications, we performed a before/after analysis as well as a time-motion study. Data quality was assessed by measuring completeness, correctness and concordance of previously and newly collected data. A cost-benefit analysis was conducted to estimate the savings using x4T per collected data element and the additional costs for introducing x4T. RESULTS The documentation workflow of patient care as well as clinical research was modified due to the introduction of the x4T system. After x4T implementation and workflow modifications, half of the redundant and error-prone process steps were eliminated. The generic x4T system allows direct transfer of routinely collected health care data into the x4T research database and avoids manual transcription steps. Since x4T has been introduced in March 2012, the number of included patients has increased by about 1000 per year. The average entire documentation time per patient visit has been significantly decreased by 70.1% (from 1116±185 to 334±83 s). After the introduction of the x4T system and associated workflow changes, the completeness of mandatory data elements raised from 82.2% to 100%. In case of the pruritus research study, the additional costs for introducing the x4T system are €434.01 and the savings are 0.48ct per collected data element. So, with the assumption of a 5-year runtime and 82 collected data elements per patient, the amount of documented patients has to be higher than 1102 to create a benefit. CONCLUSION Introduction of the x4T system into the clinical and research documentation workflow can optimize the data collection workflow in both areas. Redundant and cumbersome process steps can be eliminated in the research documentation, with the result of reduced documentation times as well as increased data quality. The usage of the x4T system is especially worthwhile in a study with a large amount of collected data or a high number of included patients.

Chronic Pruritus: Evaluation of Patient Needs and Treatment Goals with a Special Regard to Differences According to Pruritus Classification and Gender Aspects

Chronic pruritus (CP) is present in approximately one‐third of all dermatological patients. Diagnostics and treatment are challenging and impair patients’ quality of life.

Portal of medical data models: information infrastructure for medical research and healthcare

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. Methods: MDM is a registered European information infrastructure. It provides a multilingual platform for exchange and discussion of data models in medicine, both for medical research and healthcare. The system is developed in collaboration with the University Library of Münster to ensure sustainability. A web front-end enables users to search, view, download and discuss data models. Eleven different export formats are available (ODM, PDF, CDA, CSV, MACRO-XML, REDCap, SQL, SPSS, ADL, R, XLSX). MDM contents were analysed with descriptive statistics. Results: MDM contains 4387 current versions of data models (in total 10 963 versions). 2475 of these models belong to oncology trials. The most common keyword (n = 3826) is ‘Clinical Trial’; most frequent diseases are breast cancer, leukemia, lung and colorectal neoplasms. Most common languages of data elements are English (n = 328 557) and German (n = 68 738). Semantic annotations (UMLS codes) are available for 108 412 data items, 2453 item groups and 35 361 code list items. Overall 335 087 UMLS codes are assigned with 21 847 unique codes. Few UMLS codes are used several thousand times, but there is a long tail of rarely used codes in the frequency distribution. Discussion: Expected benefits of the MDM portal are improved and accelerated design of medical data models by sharing best practice, more standardised data models with semantic annotation and better information exchange between information systems, in particular Electronic Data Capture (EDC) and Electronic Health Records (EHR) systems. Contents of the MDM portal need to be further expanded to reach broad coverage of all relevant medical domains. Database URL: https://medical-data-models.org

European academy of dermatology and venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo

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.

Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

BackgroundData 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.MethodsCase 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.ResultsThe 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.ConclusionsCommon 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.

Baseline Characteristics and Prescription Patterns of Standard Drugs in Patients with Angiographically Determined Coronary Artery Disease and Renal Failure (CAD-REF Registry).

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.

Management of chronic pruritus: from the dermatological office to the specialized itch center

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.