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Background: With the assistance of digital pen and paper technology in the field of prehospital data reporting, it seems to be possible to fulfill the requirements of "documentation" as well as the requirements of "quality management". The aim of this study was to determine the "primary documentation quality" (PDQ) of a data reporting system based on digital pen and paper technology (so-called DINO) within a helicopter emergency medical service (HEMS) over a 6-month period., Results: The PDQ is defined as the proportion of prehospital documented data, which is primarily recorded correctly by the data reporting system. For the national uniform core dataset (so-called MIND2) the PDQ was 96.7%, for "checkbox" and "numeric data fields" the PDQ was 99.8% and 93.6%, respectively and for "vital data" the PDQ was 96.7% [heart rate (HF), measurement of blood pressure] and 84.1% [peripheral oxygen saturation (S(p)O2), end tidal carbon dioxide concentration (etCO2), oxygen administration (O2)]. For "measurements" the PDQ was 96.9% (time stamps) and 86.9% (time frames), for "drugs" the PDQ was 43.6% (drug name) and 69.8% (drug dosage) and for"placement of infusion" 42% (infusion name) and 85.3% (infusion time), respectively. The average time for the "verification process" after mission completion was 1.5+/-0.4 min/mission., Conclusions: The "primary documentation quality" of prehospital mission data reporting with the assistance of a digital pen and paper based documentation system (DINO) has been shown to completely fulfill the requirements of rapid and safe data documentation in actual missions, even at this early stage of development.

The process of reviewing the European pharmaceutical legislation resulted in a codex, which contains two new instruments related to marketing authorisation of biological medicines: Plasma Master File (PMF) and Vaccine Antigen Master File (VAMF). In the manufacture of plasma derivatives (e. g. coagulation factors, albumin, immunoglobulins), usually the same starting material, i. e. a plasma pool, is used for several products. In the case of vaccines, the same active substance, i.e. vaccine antigen, may be included in several combination vaccine products. The intention behind the introduction of PMF and VAMF was to avoid unnecessary and redundant documentation, and to improve and harmonise assessment by means of procedures for certification of master files on the community level.

Background: Recording of adequate mission data is of utmost importance in prehospital emergency medicine. For this, a nationwide uniform core dataset for prehospital data reporting, the so-called MIND 2, was introduced. With this procedure adequate information about structure and outcome quality, but only little information about process quality, can be obtained. Regarding the quality of data recording, primarily computer-based techniques are superior to other techniques. Against this background, the aim of this study was to develop a documentation system, which sets new standards regarding documentation dataset and documentation quality., Results: A primarily computer-based documentation system based on the "digital paper" technology was achieved. This technology allows conventional data entry via a (digital) pen and documentation on conventional paper. As the core-dataset MIND 2 was realized - furthermore, the measurements performed during prehospital management as well as data on vital signs (blood pressure, heart frequency, S(a)O(2), p(et)CO(2) etc.) were included into routine data recording. Integration of this documentation system into an already existing medical quality management system was achieved via a defined interface. Testing of this new system over a 3-month period at the helicopter emergency medical service (HEMS) "Christoph 22" showed a high degree of functionality and stability of the system. Serious problems, especially a total break-down of the whole system, were not observed during the study period., Conclusions: The new data recording concept, which is based on the "digital paper" technology, has proven to be completely satisfactory with respect to functionality and documentation quality during the test period.

Türkiye’de bağımsız denetim faaliyetleri, Türkiye Denetim Standartlarına göre yapılmakta olup, söz konusu bu standartlar Kamu Gözetimi Kurulu tarafından uluslararası standartlarla uyumlu olarak oluşturulmuş ve Resmi Gazete de yayınlanarak yürürlüğe konulmuştur. Kamu Gözetimi Kurumu tarafından yetkilendirilen "Bağımsız Denetim Kuruluşları" ve "Bağımsız Denetçiler" bağımsız denetim faaliyetini gerçekleştirmekte olup, söz konusu bu faaliyetleri sırasında işletmenin iddialarına dayanak oluşturacak birçok kanıt, belge vb. toplamak durumundadırlar. Bu belgeler ve bilgiler denetim kanıtlarıdır. Bağımsız denetçinin topladığı belgeye dayalı denetim kanıtlarının tamamı çalışma kağıtları olarak adlandırılır. Denetim raporuna temel olan çalışma kağıtları, denetçinin görüşünü destekleyen ve denetimin uluslararası denetim standartlarına uygun olarak yapıldığının kanıtını sağlayacak önemli konuların belgelendirmesidir. Bu bağlamda Kamu Gözetimi Kurumu tarafından bağımsız denetimin belgelendirilmesine ilişkin bir tebliğ yayınlanmıştır. Bu çalışmanın amacı, denetimde mesleğinde büyük önem taşıyan çalışma kağıtlarını 230 No’lu Uluslararası denetim standardı esas alınarak tanıtmaktır. Çalışmada denetimde belgelendirme kavramına değinilmiş ve çalışma kağıdı örneklerine yer verilmiştir.

Influence of digital documentation on working hours and workflow in the intensive care unit: An observational pre-post-study Abstract: The introduction of digital patient documentation systems in hospitals and intensive care units is increasing in Germany. The effects of these systems on the workflow of nurses have hardly been studied. Background: It is analysed how high the workload is with a digital documentation system compared to paper-based documentation, how the workflow changes and how the digital documentation is evaluated in comparison to paper-based in terms of usability, time required and documentation quality. Aim: Before (to) and after the introduction of the digital patient documentation system (t1), the time for documentation and the documentation frequency was measured in a prospective pre-post observation study using an app configured specifically for this purpose, and both survey periods were statistically compared (Mann-Whitney-U-test). Furthermore, a survey of nursing staff on digital patient documentation was carried out. Methods: The working time for the documentation remains the same after digitization. However, 80% of respondents state that the documentation time would have been reduced. Furthermore, the number of documentation processes decreases significantly (p = 0.03). In addition, a majority (55%) indicated an increase in documentation quality. Results: Digital patient documentation does not necessarily save working time, but it defragments the process of documentation work and has the potential to positively influence the documentation workflow.Conclusions: Digital patient documentation does not necessarily save working time, but it defragments the process of documentation work and has the potential to positively influence the documentation workflow.

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Copyright of Anaesthesiologie & Intensivmedizin is the property of DGAI e.V. - Deutsche Gesellschaft fur Anasthesiologie und Intensivmedizin e.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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Background and objective: The Working Group on Ethics in Anesthesia and Intensive Care Medicine of the Austrian Society for Anesthesiology Resuscitation and Intensive Care Medicine (ÖGARI) already developed documentation tools for the adaption of therapeutic goals 10 years ago. Since then the practical implementation of Comfort Terminal Care in the daily routine in particular has raised numerous questions, which are discussed in this follow-up paper and answered in an evidence-based manner whenever possible. Results: The practical implementation of pain therapy and reduction of anxiety, stress and respiratory distress that are indicated in the context of Comfort Terminal Care are described in more detail. The measures that are not (or no longer) indicated, such as oxygen administration and ventilation as well as the administration of fluids and nutrition, are also commented on. Furthermore, recommendations are given regarding monitoring, (laboratory) findings and drug treatment and the importance of nursing actions in the context of Comfort Terminal Care is mentioned. Finally, the support for the next of kin and the procedure in the time after death are presented. Discussion: A change in treatment goals with a timely switch to Comfort Terminal Care enables good and humane care for seriously ill patients and their relatives at the end of life and the appreciation of their previous life with the possibility of positive experiences until the end. [ABSTRACT FROM AUTHOR]

The national registry "HerediCaRe" for the evaluation and improvement of risk-adjusted prevention in hereditary breast and ovarian cancer is one of six "model registries in health services research" funded by the BMBF. In this paper, we describe and discuss the documentation and IT solution chosen for standardized data collection based on the specific functional requirements previously defined. The documentation is divided into different modules to be used individually for each patient, which are based on a previously defined catalog of documentation items. Due to special functional requirements, a specific data entry application based on ORACLE and ORACLE Forms was developed and implemented. The specific requirements included the integration of graphical pedigree representations, the structured upload of pedigree data and molecular genetic information, the automated transfer of old data from the previous system, as well as the free programmability of complex database queries for central data quality control. A database for patient-independent management of genetic risk variants was seamlessly integrated into the application and linked to the patient-related data. The advantages and disadvantages of the chosen IT solution are critically discussed. Overall, we come to the conclusion that, in view of the complex documentation and the special functional requirements, there are no alternative ready-made software products to the in-house development we have chosen., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Die Digitalisierung von Gesellschaft und Arbeit stellt neue Herausforderungen an Dokumentation, Archivierung und erneute Nutzung von Informationen und Medien durch große und kleine Einrichtungen. Zur erfolgreichen Bewältigung dieser Herausforderungen tragen Vernetzung und Qualifizierung erheblich bei. In diesen Bereichen ist nestor aktiv. Der Beitrag informiert über Geschichte, Reichweite und Angebote des Kompetenznetzwerks nestor und berichtet über aktuelle Entwicklungen während der Pandemie. Insbesondere werden die Arbeitsgruppen, Publikationen und Veranstaltungs- sowie Qualifizierungsangebote des Netzwerks vorgestellt. Der Beitrag ruft zudem zur Beteiligung im Netzwerk auf. The digitization of society and work sees institutions faced with new challenges for the documentation, archiving and re-use of information and media. Networking and qualifying measures contribute significantly to successfully meeting these challenges. In all these fields, nestor operates. The article outlines history, scope and offerings of the competence network nestor as well as recent developments during the pandemic. Working groups, publications, workshop and qualification programmes are introduced. The paper also calls on network partners to contribute and participate in the project. [ABSTRACT FROM AUTHOR]

Fortbildungsveranstaltungen zur Dokumentation wurden vom Lehrinstitut für Dokumentation (LID) in der Deutschen Gesellschaft für Dokumentation (DGD) von 1974 bis 1991 angeboten. Themen waren u. a. die dokumentarische Methodik, Arbeitsabläufe, Dienstleistungsangebote, Produkte und neuesten Informations- und Kommunikationstechnologien sowie der Umgang mit den dadurch ausgelösten Veränderungen ggf. auch aus Leitungsperspektive. Die Strukturen, Entwicklungsphasen, Themenschwerpunkte, Kooperationen – insbesondere mit Partnereinrichtungen aus der Mediendokumentation, aber auch mit regionalen Organisationen von Informationsspezialist*innen innerhalb und außerhalb der DGD – und der Stellenwert der LID-Fortbildung im Rahmen der Qualifizierungsangebote der DGD werden in diesem Beitrag beschrieben und analysiert. Training courses on documentation were offered by the Lehrinstitut für Dokumentation (LID) in the Deutsche Gesellschaft für Dokumentation (German Society for Documentation, DGD) from 1974 to 1991. Topics included documentary methodology, work processes, service offerings, products and the latest information and communication technologies, as well as dealing with change caused by these developments, if necessary also from a management perspective. The structures, development phases, main topics, cooperations – especially with partners from media documentation, but also with regional organizations of information specialists within and outside the DGD – and the significance of LID training within the framework of the DGD's qualification lines are described and analyzed in this paper. [ABSTRACT FROM AUTHOR]

Copyright of Der Ophthalmologe is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

British historian Richard Aldrich describes the relationship between intelligence and academic research as an ongoing tug-of-war over the access to intelligence archives or intelligence related files. Intelligence services tend to resist release, for the sake of protecting sensitive sources and methods, but thereby also intentionally or unintentionally distorting historical accounts. Anyone engaging in intelligence studies based on primary sources must be aware of these preconditions, and their legal and scientific ramifications. However, just as in intelligence collection, the researcher can employ innovative methods to gain insight into the intelligence process and the use of intelligence without the access to still classified files or closed archives by using alternative sources from accessible archives, personal collections of documents and private or declassified diaries. These methods can also to some extent be employed to offset the effect of accidental or intentional destruction of files or entire intelligence archives, as well as the lack of documentation due to the principle nothing on paper. [ABSTRACT FROM AUTHOR]

Assessing the quality of literature searches and their updating and adaptation require careful, comprehensive and transparent documentation. Guidelines exist for documenting the development and progress of a literature search. However, the authors are not aware of an editable template that can be used to document the literature search. Therefore, this paper aims to present a search template for the systematic and transparent development and documentation of a comprehensive literature search. The template includes essential steps of the database search as well as supplementary search options and offers a possibility for methodical and content-related justification of the included steps. It considers current guidelines for reporting search strategies. The search template is provided free of charge and is editable with common text editing programs. The contents are to be adapted according to the individual search strategies. [ABSTRACT FROM AUTHOR]

Background: The quality of preventive measures is an essential precondition for their success. A current objective of health policy in Germany is to find the criteria for quality, as well as to process and discuss them systematically with relevant stakeholders., Objectives: An assessment of the quality standards of overweight prevention in children was the main objective of the study. Scientific articles and standard-setting documents of purchasers and providers of measures were analyzed., Methods: A literature search with the meta-database MEDPILOT yielded 19 relevant papers, which were processed using a content analysis. An internet-based inquiry using the search engine Google led to 62 standard-setting documents for further analysis., Results: There is hardly any German literature on the intersection of quality standards and primary overweight prevention in children. Only six of the standard-setting documents have a focus on overweight prevention in children. Overall, there is a wide range of criteria. The documents of the central actors have wide intersection and show a common understanding of quality. Nevertheless, the documents do not relate to each other and it is not yet clear which documents guide the actions for prevention practice., Conclusions: To develop common standards, mutual recognition is needed between actors of the field, science and politics. The scientific discourse needs to interrelate better studies of primary prevention with overweight research as well as quality assessment.

Doctors are obliged by professional code and civil law (630 f German Civil Code [BGB] §) to document their medical activities in relation to patients. The documentation serves as proof of executed measures and thus for backing up medical/therapeutic issues. Documentation shall be made immediately after or during the treatment and if the original content remains recognizable, can be supplemented/modified. The patient record may be kept in paper form or in electronic form. Medical records are to be stored at least for 10 years. Some special laws (eg. laws governing X rays, Transfusion Act) require that documents be stored for longer periods. Documentation errors are - unlike patient information errors/medical malpractice - no basis for damages claims by the patient, but may result in medical malpractice process with the burden of proof in favor of the patient (§ 630 h BGB). The patient has, in principle, the right to inspect the medical documents relating to him., (© Georg Thieme Verlag Stuttgart · New York.)

Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face-to-face panel meeting. The resultant 12-item TIDieR checklist (brief name, why, what (materials), what (procedure), who intervened, how, where, when and how much, tailoring, modifications, how well (planned), how well (actually carried out)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with a detailed explanation of each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure the accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information., (© Georg Thieme Verlag KG Stuttgart · New York.)

Clinical reviews are an important part of the medical literature offering the reader condensed information on a specific topic. In radiology and nuclear medicine most clinical reviews have a subjective character as they have been written in a rather narrative way. Based on their low level of evidence these narrative reviews are frequently not being considered for establishment of clinical guidelines. The aim of this paper is to aid the reader in writing a good clinical review by highlighting the different aspects of a systematic review.

Although part of the medical fold since the 1870s, hypnosis was long relegated to the margins, recognised and used by only a relatively small group of medical professionals. In the decades around 1900 hypnotic techniques were monopolised as a form of medical treatment through a long and in no way linear process. Hypnosis of laymen was vehemently opposed, however, denounced as being far too dangerous. And yet, medical participation in the aura of spectacular intervention into the human psyche garnered support. The medium of both documentary and instructional film served an important function in this regard, conveying popular interest in acknowledging hypnosis as a scientific method. On the basis of four medically accredited films on hypnosis from 1920 to 1936, this paper attempts to investigate how medical experts and these genres, as part of their effort to claim hypnosis from the realm of public spectacle and parapsychological experimentation, worked to stabilise hypnosis as a purified form of medical and psychiatric practice.

In the second half of the nine- teenth century, clinical demonstrations became the dominant teaching method in psychiatry, playing a key role in medical-professional disputes, as well. This paper traces this widely used though historiographically neglected practice of knowledge implementation and mediation, as demonstrated in the psychiatric clinic of the Berlin Charité (Psychiatrische und Nervenklinik der Berliner Charité) from 1881 to 1927. Documentation of this practice, found within individual medical records, forms the basis of this research. The concept of 'theatricality' assists in uncovering the dramatic quality of the clinical demonstration: Psychiatric knowledge was not simply disseminated through such a practice; rather, such knowledge was first performatively created through the very logic of its presentation of exemplary patient histories, as well as through the examination and diagnostic positioning of its patients. The 'success' of such presentations depended on many variables, related to staff, time, place, and other situational factors. These include the presence of appropriate lecture halls, the availability and calculated selection of patients, and the employment of specific performative techniques by doctors for the sake of producing desired results. As one effect, clinical demonstrations also encouraged patients to both learn and rehearse behavior considered relevant to the particular diagnosis that was to be demonstrated.

Copyright of Information -- Wissenschaft und Praxis is the property of De Gruyter and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background and Purpose: After incorporating treatment planning and the organisational model of treatment planning in the operating schedule system (BAS, "Betriebsablaufsystem"), complete document qualities were embedded in the digital environment. The aim of this project was to integrate all documents independent of their source (paper-bound or digital) and to make content from the BAS available in a structured manner. As many workflow steps as possible should be automated, e.g. assigning a document to a patient in the BAS. Additionally it must be guaranteed that at all times it could be traced who, when, how and from which source documents were imported into the departmental system. Furthermore work procedures should be changed that the documentation conducted either directly in the departmental system or from external systems can be incorporated digitally and paper document can be completely avoided (e.g. documents such as treatment certificate, treatment plans or documentation). It was a further aim, if possible, to automate the removal of paper documents from the departmental work flow, or even to make such paper documents superfluous. In this way patient letters for follow-up appointments should automatically generated from the BAS. Similarly patient record extracts in the form of PDF files should be enabled, e.g. for controlling purposes., Method: The available document qualities were analysed in detail by a multidisciplinary working group (BAS-AG) and after this examination and assessment of the possibility of modelling in our departmental workflow (BAS) they were transcribed into a flow diagram. The gathered specifications were implemented in a test environment by the clinical and administrative IT group of the department of radiation oncology and subsequent to a detailed analysis introduced into clinical routine., Results: The department has succeeded under the conditions of the aforementioned criteria to embed all relevant documents in the departmental workflow via continuous processes. Since the completion of the concepts and the implementation in our test environment 15,000 documents were introduced into the departmental workflow following routine approval. Furthermore approximately 5000 appointment letters for patient aftercare per year were automatically generated by the BAS. In addition patient record extracts in the form of PDF files for the medical services of the healthcare insurer can be generated.

The growing number of revisions in orthopaedic surgery as well as the multifactorial reasons for implant failure give cause for taking a closer look at the clinical documentation of adverse events. Based on our long-term experience it is our goal to present recommendations for an adequate documentation and filing. In the framework of the introduction of a quality management system (ISO 9001:2008) in our hospital, a process was developed for reportable incidents with medical devices regulating adequate documentation. Therefore, specific forms were developed. The retrievals are stored for subsequent damage analyses and are available for possible legal claims and tracking. A file should be opened for each reportable incident containing information about the event, a copy of the obligatory BfArM report, surgery report, medical device labels, radiographs and photographs. Declarations of agreement as well as handover certificates should be maintained in order to keep record of the retrievals. In order to assure consistent documentation, we recommend use of specific forms as presented in this paper. Identification of risk factors for implant failure and a long-term reduction of damage cases will only be possible under consequent incident reporting and responsible documentation of adverse events. Processing of cases of damage is accelerated and simplified by the presented recommendations and forms. Together with the newly established joint replacement registry, a higher quality of patient treatment and implant safety should be obtained., (Georg Thieme Verlag KG Stuttgart · New York.)

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The paper attempts to reconstruct the writing of published case histories. Due to the establishment of a scientific classification system in psychiatry there were at the Charité several changes from the late 1870s onwards: (1) Not only was the documentation in the clinical records altered significantly, but also (2) the archive was reorganized into a double filing system and (3) the casuistic made a development from describing seldom or sensational cases into a mode which aimed to unfold psychiatric theory through 'typical cases'. Original medical records, the internal documentation of psychiatric observation, will be compared to their published version. Both, the narrative of a case study and the documentation in the clinical records reveal performative processes of observation and documentation.

The paper focuses on the material basis of the development of modern clinical documentation. With the examples of Berlin and Paris medicine, it analyzes the various ways of recording clinical data in the 18th century, from where they came, and how they were introduced into bedside observations. Particular interest is given to the interrelation between administrative techniques (registration, book-keeping etc.) and the practices of medical recording developed within the hospitals. Comparing Berlin and Paris makes it possible to work out the differences in writing cultures and to consider the local interdependencies. With this approach it can be demonstrated that the "patient record" was already established as a patient related recording system in the form of loose files in the early 19th century.

The identification of unpublished data is an important component in the assessment of drugs for a systematic review. This is why searching in clinical trials registries is indispensable. However, this type of search is not regularly conducted. At present, clinical trials registries that also contain results data are still seldom-used sources, which may be due to a number of reasons. On the one hand, there are a large number of clinical trials registries whose quality is difficult to judge sometimes; on the other hand, their heterogeneity and partly inadequate functionality such as, for example, the lack of export options, complicate searches of these sources. The present paper addresses the features of searches in clinical trials registries and describes the approach taken by the German Institute for Quality and Efficiency in Health Care (IQWiG). Initially, we describe the various types of registries and offer assistance with the selection of the clinical trials registries to be searched. A further focus lies on the description of the search procedure itself, as well as on the selection of the relevant registry entries and the documentation of this process in order to support those planning their own search in clinical trials registries.

In critical care environments, important medical and economic challenges are presented by the enhancement of therapeutic quality and the reduction of therapeutic costs. For this purpose, several clinical studies have demonstrated a positive impact of the adoption of so-called clinical guidelines. Clinical guidelines represent well documented best practices in healthcare and are fundamental aspects of evidence-based medicine. However, at the bedside, such clinical guidelines remain difficult to use by clinical staff. The knowledge-based technology SmartCare allows incorporation of arbitrary computerized clinical guidelines into various medical target systems. SmartCare constitutes a clinical guideline engine because it executes one or more clinical guidelines on a specific medical device. SmartCare was initially applied for the automated control of a mechanical ventilator to assist the process of weaning from a medical device. The methodology allows further applications to be implemented effectively with other medical devices and/or with other appropriate guidelines. In this paper, we report on the methodology and the resulting versatility of such a system, as well as the clinical evaluation of SmartCare/PS and its perspectives.