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Im Rahmen eines Forschungsprojektes soll eine Plattform für die Vermittlung von Telekonsilen und die Bereitstellung einer Konsilakte an die Telematik-Infrastruktur (TI) angeschlossen werden. Um sowohl eine bestmögliche Skalierbarkeit als auch eine optimale Integrierbarkeit in bestehende Systeme und Anwendungen zu erreichen, wurde HL7 FHIR als syntaktischer Standard für das Reha-Konsil festgelegt. Dieses Dokument liefert einen systematischen Überblick über die notwendigen Schritte und Voraussetzungen, um diesen Anschluss zu bewerkstelligen.
Design propositions for nudging in healthcare: Adoption of national electronic health recordsystems
(2023)
Objectives: Electronic health records (EHRs) are considered important for improving efficiency and reducing costs of ahealthcare system. However, the adoption of EHR systems differs among countries and so does the way the decision to par-ticipate in EHRs is presented. Nudging is a concept that deals with influencing human behaviour within the research streamof behavioural economics. In this paper, we focus on the effects of the choice architecture on the decision for the adoption ofnational EHRs. Our study aims to link influences on human behaviour through nudging with the adoption of EHRs to inves-tigate how choice architects can facilitate the adoption of national information systems.
Methods: We employ a qualitative explorative research design, namely the case study method. Using theoretical sampling,we selected four cases (i.e., countries) for our study: Estonia, Austria, the Netherlands, and Germany. We collected and ana-lyzed data from various primary and secondary sources: ethnographic observation, interviews, scientific papers, homepages,press releases, newspaper articles, technical specifications, publications from governmental bodies, and formal studies.
Results: The findings from our European case studies show that designing for EHR adoption should encompass choice archi-tecture elements (i.e., defaults), technical elements (i.e., choice granularity and access transparency), and institutional ele-ments (i.e., regulations for data protection, information campaigns, and financial incentives) in combination.
Conclusions: Our findings provide insights on the design of the adoption environments of large-scale, national EHR systems.Future research could estimate the magnitude of effects of the determinants.
Gesundheit und Soziales
(2023)
Objectives
The European University Association (EUA) defines “employability” as a major goal of higher education. Therefore, competence-based orientation is an important aspect of education. The representation of a standardized job profile in the field of medical informatics, which is based on the most common labor market requirements, is fundamental for identifying and conveying the learning goals corresponding to these competences.
Methods
To identify the most common requirements, we extracted 544 job advertisements from the German job portal, STEPSTONE. This process was conducted via a program we developed in R with the “rvest” library, utilizing web crawling, web extraction, and text mining. After removing duplicates and filtering for jobs that required a bachelor's degree, 147 job advertisements remained, from which we extracted qualification terms. We categorized the terms into six groups: professional expertise, soft skills, teamwork, processes, learning, and problem-solving abilities.
Results
The results showed that only 45% of the terms are related to professional expertise, while 55% are related to soft skills. Studies of employee soft skills have shown similar results. The most prevalent terms were programming, experience, project, and server. Our second major finding is the importance of experience, further underlining how essential practical skills are.
Conclusions
Previous studies used surveys and narrative descriptions. This is the first study to use web crawling, web extraction, and text mining. Our research shows that soft skills and specialist knowledge carry equal weight. The insights gained from this study may be of assistance in developing curricula for medical informatics.
As mobile technology continues to improve, more and more professional services are being offered as mobile apps. This paradigm shift also affects eHealth applications. Digital identities in nation-wide eHealth infrastructures are often realized via smart cards, which however, do not support mobile applications well. In this paper we propose a concept of a mobile eID for eHealth based on smartphones with embedded secure hardware, an mobile authenticator app and an account manager as well as an Identity Provider (IdP) as backend services. The practical applicability of the concept is shown using the example of the German eHealth infrastructure. Our method generates a cryptographic key pair in secure hardware on the user’s smartphone, registers it on the IdP and uses it to authenticate on the IdP. The security of the private key and the integrity of the smartphone is also validated and attestated. The user’s established smartcard-based identity "Electronic Health Card" (EHC) forms the trust anchor. To authenticate against specialist eHealth apps the IdP issues standard-compliant OAuth2.0/OIDC tokens with a limited period of validity. Furthermore, in our security analysis we demonstrate that based on specific security requirements for smartphones and operating systems, at least the eIDAS security level "substantial" related to the technical security aspects of the system can be achieved. On the basis of this research German legislation was adjusted and "digital identities" supplementary to the smartcard-based EHC will be issued from 2023 in the German eHealth infrastructure.
Telepräsenzroboter für die Pflege und Unterstützung von Schlaganfallpatinnen und -patienten (TePUS)
(2020)
Vorgestellt wird das Forschungsvorhaben des interdisziplinären Forschungsprojekts „DeinHaus 4.0 – Telepräsenzroboter für die Pflege und Unterstützung von Schlaganfallpatientinnen und -patienten (TePUS)“. Über geeignete Robotersysteme sollen den Proband*innen individuell abgestimmte Angebote aus den Bereichen Telenursing und Teletherapie
zur Verfügung gestellt werden. Hierbei werden einerseits Telepräsenzsitzungen durchgeführt, anderseits kommen verschiedene Apps zum Einsatz. Die Interventionen werden mittels eines Mixed-Methods-Ansatzes evaluiert. Begleitend werden Technikakzeptanz und Nutzungsbereitschaft untersucht.
Objectives
Tumor size is a well recognized prognostic factor in early stage cervical carcinoma (CX). However, limited knowledge exists about the value of tumor size in surgically treated CX with extrauterine extension.
Methods
245 cases of local advanced CX (FIGO stage IIA and IIB) who received upfront surgery were evaluated regarding tumor size, regarding the prediction of pelvic lymph node involvement and recurrence free and overall survival during a median follow-up time of 54 months (95% CI 45.4–62.6 months). Tumors larger than 4 cm were defined as bulky stage disease.
Results
Bulky disease was seen in 46.1% (113/245). 60.2% of these patients showed pelvic lymph node involvement, compared to 42.4% (56/132) in non-bulky tumors (p = 0.006; odds ratio: 2.2 [95% CI: 1.3–3.6]). Patients with bulky tumors showed an increase of recurrent disease (40.2% vs. 28.0%; p = 0.045). The relative risk for recurrent disease was 1.97 (95% CI: 1.3–3.0). The 5-year overall survival rate was significantly lower (67.7% [95% CI: 58.2–74.8] vs. 49.5% [95% CI: 36.8–59.1]; p = 0.0015). In multivariate analysis, tumor stage, pelvic lymph node involvement and maximal tumor size were independent prognostic factors.
Conclusions
The results suggest that tumor size, defining bulky disease as tumors larger than 4 cm, is of prognostic impact also in FIGO stage II cervical carcinomas. A revised FIGO/TNM classification system similar to the subgrouping of stage IB CX is recommended for stage II using a cut-off value of 4 cm as discriminator: stage IIA1 and stage IIB1 for tumors with ≤ 4 cm and IIA2 and IIB2 for tumors > 4 cm (i.e. bulky disease).
Objectives: Different patterns of invasion (representing different grades of tumor cell dissociation) are associated with prognostic outcome in cancer. We evaluated the prognostic value of different patterns of invasion (PI) in cervical carcinomas (CX).
Methods: Six hundred eleven surgically treated CX (FIGO IB to IIB) were re-evaluated histologically regarding the PI, using a three-level scoring system. Closed PI was defined as cohesive growth with well-delineated (pushing) borders. In finger-like PI the tumor grows in solid cords/trabecles. Highly dissociative growth in small groups or single cells was defined as spray-like PI. Types of PI were correlated to tumor stage, histo-morphologic factors and prognostic outcome.
Results: Sixty percent of the tumors showed a spray-like PI, 30% a finger-like PI and only 7.4% were of the closed type. Spray-like PI showed a significant correlation with advanced stage disease, lymphovascular space involvement, poorly differentiated tumors and pelvic lymph node metastases. Spray-like PI was accompanied by a reduced 5-year overall survival when compared to the finger-like and closed PI (68.7% vs. 80.9% vs. 88.5%; P=0.0004). The prognostic impact of the PI disappeared in node-positive patients (P=0.06) but persisted in patients without pelvic lymph node disease (P=0.03). In multivariate analysis, using COX regression model, the PI represented as independent prognostic factor.
Conclusions: Spray-like PI (i.e., highest degree of tumor cell dissociation) is associated with advanced tumor stages, increased rate of recurrency and a reduced overall survival. In separate analysis of patients with and without lymph node metastases, the impact of PI persisted only in node-negative cases as a prognostic factor.
Several kinds of cellular adhesion molecules, like different splicing variants of CD 44, have gained important as prognostic or markers for metastatic disease. Fresh frozen samples from 64 cervical carcinoma (CX) were stored in liquid nitrogen and examined using ELISA-technique, testing the prognostic impact. Normal cervical tissue served as control. CD 44-v6 concentration, was significant elevated in tumor tissue, when compared to the controls (P=0.04). There was no correlation to tumor stage (P=0.61), lymphovascular space involvement (P=0.075) or pelvic lymph node involvement (P=0.81). The CD 44-v6 concentration was not informative regarding recurrence-free and overall survival. Contrary to immunohistochemistry, the quantification of CD 44-v6 using ELISA-technique does not provide any further information.
Objective: To determine the utility of DNA content and DNA-related variables of proliferative activity regarding prognosis in cervical cancer.
Study design: DNA image (ICM) andflow cytometry (FCM) were performed to determine the DNA index (DI), 5c-exceeding rate (5c-ER), S-phase fraction (SPF) and proliferation index (PI) in 163 patients with surgically staged pT1b1-pT2b squamous cell cancer of the uterine cervix and treated with primary radical hysterectomy. ICM was performed on imprint cytology, obtained from fresh tumor tissue, which was also used for FCM. Results were analyzed using the chi2 test and Cox regression analysis for risk of pelvic lymph node involvement, tumor recurrence and recurrence-free survival (RFS).
Results: ICM was performed on all 163 and FCM on 133 samples. One-third of the tumors showed DNA aneuploidy. Analysis demonstrated prognostic significance of a DI > or = 1.70, with a (70:30) 2.3-fold risk of recurrence (P=.024) and reduced RFS of 10 months (P=.003) in cases of DI > or = 1.70. A high 5c-ER > 11% was associated with pelvic lymph node involvement and decreased RFS (P < or = .04). Significantly more relapses were found in tumors with SPF > 12% (70.8% vs. 29.2%, P=.007). RFS was markedly reduced in tumors with high SPF (52.3 vs. 61.1 months, P=.011). Low proliferative tumors (PI<25%) were associated with lower stage (P=.036) and increased RFS (61.2 vs. 47.1 months, P=.028). In multivariate analysis of clinicopathologic variables (pT category, nodal status, lymphovascular space involvement) and DNA related variables, pelvic lymph node involvement was the only significant predictor of RFS. In patients with nodal involvement, tumors with DI >1.70 were associated with lessfavorable outcomes.
Conclusion: DNA-related variables of cell cycle analysis were valuablefor predicting prognosis in cervical cancer patients. Tumors with DI>1.70, 5c-ER >11% and high proliferative activity (SPF>12%, PI>25%) represent a subgroup with a poor prognosis.
Recent developments in lasers have provided us the possibility of laser ocular surgery. The xenon, argon, neodymium:YAG and dye lasers have been successfully used in out-patient clinics. The excimer laser has been attracting researchers' interest in the new application of laser to cornea and lens. The erbium:YAG laser emits a 2.94-microns beam that can ablate the transparent ocular tissues such as lenses and corneas. The author has applied this laser to the cornea, lens, vitreous and other ocular tissues. The erbium:YAG laser beam was directed through a 1.5-meter-long, 200-microns-diameter fiberoptic guide. The radiant energy measured about 50 mJ at the end of the probe. The laser was emitted as a 400-microsecond pulse. Freshly enucleated rabbit eyes were used in this study. Laser burns were applied to the tissue surface at various energy settings. At minimal power, the tissues were coagulated by the erbium:YAG laser application. At a power of more than 636-954 mJ/mm2, tissue began to evaporate; the tissue loss was observed under a surgical light microscope. Corneal photoablation, lens ablation, iridotomy, trabeculotomy, cutting of the vitreous and retinal ablation were easily performed. Like the excimer laser, the erbium:YAG laser is a potential tool for ocular surgery.
Objective
The expression of uPA and PAI‐1 as parameters of tumour‐associated proteolysis has been implicated in the process of tumour cell invasion and the metastatic process. However, there is limited information on the impact of these parameters in cervical carcinoma.
Methods
Quantitative levels for uPA (n = 114) and PAI‐1 (n = 103) were researched in operatively treated, surgically staged squamous cell cancer of the uterine cervix, using an ELISA‐technique. Results were assessed regarding their impact in predicting pelvic lymph nodes metastases, tumour recurrence rate and recurrence free survival (RFS) using uni‐ and multivariate analysis.
Results
Median levels of both parameters were significantly higher in tumour tissue than in normal cervical tissue (p < 0.001). Detection of uPA gave no useful prognostic information. PAI‐1 concentration showed a positive correlation with advanced tumour stage (p = 0.008), but no significant correlation with nodal status (pN0: 2.6 vs. pN1: 4.0 ng/mg protein; p = 0.092). Using a cut‐off level of 2.4 ng/mg protein, patients with elevated PAI‐1 levels demonstrated reduced RFS (45.9 versus 52.9 months; p = 0.1). Multivariate analysis, including nodal status, tumour stage, lymphovascular space involvement and grading failed to demonstrate any prognostic impact of uPA and PAI‐1.
Conclusions
The results indicate, that PAI‐1 expression is of some prognostic impact in cervical cancer, indicating an association of elevated PAI levels with local tumour progression and reduced recurrence‐free survival.
Mögliche Auswirkungen der eIDAS-Verordnung auf die Telematikinfrastruktur und die eArztausweise
(2015)
Fragestellung: Molekulare Analysen haben deutlich gemacht, dass maligne Tumoren durch Veränderungen des Genoms hervorgerufen werden. Im Gegensatz zu den erblich bedingten Tumorerkrankungen sind die Kenntnisse zur Bedeutung familiärer Faktoren bei den sog. sporadischen Tumoren, insbesondere beim Zervixkarzinom (CX) begrenzt. Material und Methode: Patientinnen des CX-Registers der Universitäts-Frauenklinik wurden retrospektiv bezüglich der Familienanamnese (FA) analysiert. Als positive FA wurde eine maligne Tumorerkrankung bei einem oder mehreren Verwandten ersten Grades definiert. Es wurde unterschieden, ob es sich um Zervixkarzinome, andere gynäkologische Malignome (außer Mammakarzinom) oder eine extragenitale Lokalisation handelte. Diese Daten wurden zum Erkrankungsalter und zum Nachweis pelviner Lymphknotenmetastasen in Beziehung gesetzt. Ergebnisse: 159/737 Frauen (21,6 %) wiesen eine positive FA auf. In 10,7 % der Fälle war mehr als ein Verwandter ersten Grades erkrankt; bei 6,9 % Angehörige ersten und zweiten Grades. Weibliche Verwandte ersten Grades von 42 Frauen wiesen Malignome des weiblichen Genitaltraktes (außer CX) auf. In 6,9 % waren die Mutter und/oder die Schwester an einem Zervixkarzinom erkrankt. Das Durchschnittsalter der Patientinnen mit positiver Familienanamnese (FA) unterschied sich nicht von dem derjenigen mit leerer FA, wohl aber bei getrennter Betrachtung nach der Tumorlokalisation. Bezüglich des Tumorstadiums (pTNM) und der Zahl der Patientinnen mit histologisch nachgewiesenen pelvinen Lymphknotenmetastasen bestand kein Unterschied. Schlussfolgerungen: Die bisherigen Ergebnisse deuten auch beim Zervixkarzinom auf eine familiäre Belastung hin. Dabei existieren offenbar Familien, in denen mit HPV-assoziierte Präkanzerosen bzw. Tumoren vermehrt auftreten. Besonders gefährdet sind Patientinnen, deren weibliche Anverwandte ersten Grades bereits an einer zervikalen Präkanzerose (besonders CIN III) oder einem invasiven CX erkrankt sind. Diese Frauen sollten einem engmaschigen Screening unterzogen werden.
Medizinische Daten, die - wie derzeit für die Telematik-Infrastruktur nach §291a SGB V spe-zifiziert - auch außerhalb der physischen Kontrolle der Eigentümer oder Ersteller (also z.B. außerhalb von Arztpraxen oder Klinken) auf Servern kryptographisch verschlüsselt gespeichert werden, müssen sehr lange vertraulich bleiben. Insbesondere darf der technische Betreiber des Servers, der die Daten speichert, keinen Zugriff erlangen. Es kann jedoch keine verlässliche Aussage dahingehend getroffen werden, ob die heute eingesetzten kryp-tographischen Algorithmen in 30 oder 40 Jahren die Vertraulichkeit der medizinischen Daten weiterhin gewährleisten. Es wird ein Verfahren vorgestellt, welches das Problem der langfristigen Sicherheit von verschlüsselt gespeicherten medizinischen Daten aus kryptographischer Sicht löst. Die Anwendung des Verfahrens wird am Beispiel einer nach den derzeit bekannten gematik-Spezifikationen definierten Infrastruktur veranschaulicht. Es wird von einer getrennten Speicherung von verschlüsselten medizinischen Daten und Schlüsselmaterial ausgegangen. Die Daten werden an der Datenquelle (Konnektor, z.B. eines Arztes) mit einem Einmalblock (One Time Pad, OTP) verschlüsselt. Sie sind damit beweisbar sicher verschlüsselt, weil das One-Time-Pad-Verschlüsselungsverfahren beweisbar „perfekt geheim“ ist. Der OTP-Schlüssel wird mit einem symmetrischen Schlüssel verschlüsselt, der wiederum mit den asymmetrischen Schlüsseln aller Zugriffsberechtigten verschlüsselt wird. Die kryptographische, technische und organisatorische Sicherheit des Verfahrens sowie seine Voraussetzungen und Kosten werden analysiert.
Die fortschreitende Digitalisierung des Gesundheitswesens ebnet auch den Weg einer stärkeren Verbreitung der telemedizinischen Versorgung in Deutschland. Die Politik erleichtert diesen Weg, z.B. mit dem eHealth-Gesetz oder mit der Lockerung des "Fernbehandlungsverbots" durch den Deutschen Ärztetag. Dabei wird schon aus der Definition (siehe z.B. die unten stehende Definition der AG Telemedizin) klar, dass Telemedizin keine neue medizinische Disziplin begründet. Bei Telemedizin handelt es sich nur um ein technisches Werkzeug in Kombination mit geeigneten klinischen Prozessen, damit bestehende medizinische Expertise unter Einsatz von Informations- und Kommunikationstechnologien räumliche Entfernungen oder einen zeitlichen Versatz überbrücken kann. Patientinnen und Patienten können also behandelt werden, auch wenn sie vom Arzt räumlich entfernt sind.
Medical confidentiality is very important because it builds the fundament of trust between doctors and patients. In modern health services data protection is essential. But there are also other important security objectives, such as integrity and authenticity of medical data and health services, as their breach can potentially lead to life threatening conditions. State of the art security mechanisms are necessary to protect medical data and services and prevent attacks known as “hacking”. They should include in particular cryptography, as you can usually rely on mathematics, more than in software security and access control mechanisms. As patients normally cannot assess the security of a service, security audits or certifications of health services should be provided to generate trust and confidence.