[Certification by the German Society for Neurorehabiliation, DGNR : Performance and quality of the "Centers for weaning from a ventilator in early neurological and neurosurgical rehabilitation"]. / Zertifizierung der Deutschen Gesellschaft für Neurorehabilitation e. V., DGNR : Leistung und Qualität der "Zentren für Beatmungsentwöhnung in der neurologisch-neurochirurgischen Frührehabilitation".

BACKGROUND: Certification of centers for weaning from a ventilator in neurological neurosurgical early rehabilitation (NNER) by the German Society for Neurorehabilitation (DGNR) is possible since 1 October 2021. OBJECTIVE: The results of certification of facilities in the first year after starting the procedure are presented. MATERIAL AND METHODS: As part of the certification process 28 criteria are assessed including a set of mandatory characteristics of the facility. The criteria are divided into structural criteria (i = 7), diagnostic criteria (i = 6), personnel criteria (i = 3), internal organization criteria (i = 7), and quality management criteria (i = 5). RESULTS: A total of 13 centers were certified in the first year, with a combined total of 283 beds for weaning from a ventilator in the NNER and served 2278 persons to be weaned from a ventilator in the year before certification, with a median of 134 per facility (range 44-414). Only rarely was weaning unsuccessful, requiring conversion to home mechanical ventilation before discharge (invasive home mechanical ventilation median per facility 10 persons, range 2-25; non-invasive home mechanical ventilation median 0 persons, range 0-57). A high level of process and structural quality was documented for the certified centers: across all areas of assessment, the individual certification criteria were met in the vast majority of cases (median degree of complete fulfilment 86%) or met with improvement potentials documented by the auditors (median 11%). CONCLUSION: Successful weaning in NNER and a high level of process and structural quality can be demonstrated by the certification results of centers that follow this integrative approach to weaning from a ventilator in a NNER setting.

S2k-Guideline SARS-CoV-2, COVID-19 and (early) rehabilitation - a consensus-based guideline for Germany.

The consensus-based guideline "SARS-CoV-2, COVID-19 and (early) rehabilitation" for Germany has two sections: In the first part, the guideline addresses infection protection-related procedures during the COVID-19 pandemic. In the second part, it provides practice recommendations for rehabilitation after COVID-19. The specific recommendations for rehabilitation after COVID-19 as issued by 13 German medical societies and two patient-representative organizations are presented together with general background information for their development.

Feasibility, coverage, and inter-rater reliability of the assessment of therapeutic interaction by a humanoid robot providing arm rehabilitation to stroke survivors using the instrument THER-I-ACT.

Objective: The instrument THERapy-related InterACTion (THER-I-ACT) was developed to document therapeutic interactions comprehensively in the human therapist-patient setting. Here, we investigate whether the instrument can also reliably be used to characterise therapeutic interactions when a digital system with a humanoid robot as a therapeutic assistant is used. Methods: Participants and therapy: Seventeen stroke survivors receiving arm rehabilitation (i.e., arm basis training (ABT) for moderate-to-severe arm paresis [n = 9] or arm ability training (AAT) for mild arm paresis [n = 8]) using the digital therapy system E-BRAiN over a course of nine sessions. Analysis of the therapeutic interaction: A total of 34 therapy sessions were videotaped. All therapeutic interactions provided by the humanoid robot during the first and the last (9th) session of daily training were documented both in terms of their frequency and time used for that type of interaction using THER-I-ACT. Any additional therapeutic interaction spontaneously given by the supervising staff or a human helper providing physical assistance (ABT only) was also documented. All ratings were performed by two trained independent raters. Statistical analyses: Intraclass correlation coefficients (ICCs) were calculated for the frequency of occurrence and time used for each category of interaction observed. Results: Therapeutic interactions could comprehensively be documented and were observed across the dimensions provision of information, feedback, and bond-related interactions. ICCs for therapeutic interaction category assessments from 34 therapy sessions by two independent raters were high (ICC ≥0.90) for almost all categories of the therapeutic interaction observed, both for the occurrence frequency and time used for categories of therapeutic interactions, and both for the therapeutic interaction performed by the robot and, even though much less frequently observed, additional spontaneous therapeutic interactions by the supervisory staff and a helper being present. The ICC was similarly high for an overall subjective rating of the concentration and engagement of patients (0.87). Conclusion: Therapeutic interactions can comprehensively and reliably be documented by trained raters using the instrument THER-I-ACT not only in the traditional patient-therapist setting, as previously shown, but also in a digital therapy setting with a humanoid robot as the therapeutic agent and for more complex therapeutic settings with more than one therapeutic agent being present.

Analysis of the therapeutic interaction provided by a humanoid robot serving stroke survivors as a therapeutic assistant for arm rehabilitation.

Objective: To characterize a socially active humanoid robot's therapeutic interaction as a therapeutic assistant when providing arm rehabilitation (i.e., arm basis training (ABT) for moderate-to-severe arm paresis or arm ability training (AAT) for mild arm paresis) to stroke survivors when using the digital therapeutic system Evidence-Based Robot-Assistant in Neurorehabilitation (E-BRAiN) and to compare it to human therapists' interaction. Methods: Participants and therapy: Seventeen stroke survivors receiving arm rehabilitation (i.e., ABT [n = 9] or AAT [n = 8]) using E-BRAiN over a course of nine sessions and twenty-one other stroke survivors receiving arm rehabilitation sessions (i.e., ABT [n = 6] or AAT [n = 15]) in a conventional 1:1 therapist-patient setting. Analysis of therapeutic interaction: Therapy sessions were videotaped, and all therapeutic interactions (information provision, feedback, and bond-related interaction) were documented offline both in terms of their frequency of occurrence and time used for the respective type of interaction using the instrument THER-I-ACT. Statistical analyses: The therapeutic interaction of the humanoid robot, supervising staff/therapists, and helpers on day 1 is reported as mean across subjects for each type of therapy (i.e., ABT and AAT) as descriptive statistics. Effects of time (day 1 vs. day 9) on the humanoid robot interaction were analyzed by repeated-measures analysis of variance (rmANOVA) together with the between-subject factor type of therapy (ABT vs. AAT). The between-subject effect of the agent (humanoid robot vs. human therapist; day 1) was analyzed together with the factor therapy (ABT vs. AAT) by ANOVA. Main results and interpretation: The overall pattern of the therapeutic interaction by the humanoid robot was comprehensive and varied considerably with the type of therapy (as clinically indicated and intended), largely comparable to human therapists' interaction, and adapted according to needs for interaction over time. Even substantially long robot-assisted therapy sessions seemed acceptable to stroke survivors and promoted engaged patients' training behavior. Conclusion: Humanoid robot interaction as implemented in the digital system E-BRAiN matches the human therapeutic interaction and its modification across therapies well and promotes engaged training behavior by patients. These characteristics support its clinical use as a therapeutic assistant and, hence, its application to support specific and intensive restorative training for stroke survivors.

[Slow demographic change and neurological rehabilitation-Part 2: what we can do]. / Schleichender demografischer Wandel und neurologische Rehabilitation ­ Teil 2: Handlungsmöglichkeiten.

In its current state the German healthcare system will not be able to adequately care for a growing proportion of older patients with a decreasing healthcare work force. This is particularly so in the postacute care of severely ill patients. In a second of two parts we discuss the perspectives and options at hand. A major conclusion is that substantial gains could be obtained by regulatory adjustments that better align acute care and rehabilitative measures.

[Slow demographic change and neurological rehabilitation-Part 1: state of affairs]. / Schleichender demografischer Wandel und neurologische Rehabilitation ­ Teil 1: Situationsbeschreibung.

In the next two decades the aging baby boomers in Germany will gradually be leaving the work force. They are being followed by the much less numerous, "baby bust" generation who now need to finance and staff healthcare for the growing number of old people in society. In order to care for more needy persons with a smaller working population, the healthcare system must be restructured; however, despite these worrisome prospects, the awareness of the problem is still low in many areas. Here we focus on the area in the healthcare system that is growing particularly rapidly and additionally has the greatest need of personnel per patient: the care of the critically ill and functionally impaired patients. The lack of coordination of hospitals, rehabilitation centers and nursing institution is historical in origin. It promotes the tendency to discharge functionally impaired patients to nursing facilities without giving them a chance for recovery of functional autonomy. As the demographic change progresses, this tendency threatens to increase. In a first of two parts, we attempt to describe the present situation.

S2k-Leitlinie SARS-CoV-2, COVID-19 und (Früh-) Rehabilitation ­ eine Kurzfassung mit allen Empfehlungen im Überblick.

The consensus-based SARS-CoV-2, COVID-19, and Rehabilitation Practice Guideline provides recommendations that take both infection prevention and the pursuit of therapeutic goals in rehabilitation settings during the coronavirus pandemic into account. The Practice Guideline provides guidance how to prevent SARS-CoV-2 infections in rehabilitation settings in a first part. The guideline's second part addresses rehabilitation for patients affected by COVID-19 starting with interventions on intensive care units, during early rehabilitation, post-acute rehabilitation, in outpatient and community rehabilitation settings, as well as long-term care, e. g. for COVID-19 survivors with Long- or Post-COVID.The updated second version of the Practice Guideline (dating from 01.11.2021) is a consensus-based guideline developed by a representative panel of healthcare professionals from 15 medical societies covering various rehabilitation disciplines, infectious diseases, hospital hygiene, and epidemiology. The abbreviated version provides an overview of all recommendations given.

Functional MRI in Radiology-A Personal Review.

We, here, provide a personal review article on the development of a functional MRI in the radiology departments of two German university medicine units. Although the international community for human brain mapping has met since 1995, the researchers fascinated by human brain function are still young and innovative. However, the impact of functional magnetic resonance imaging (fMRI) on prognosis and treatment decisions is restricted, even though standardized methods have been developed. The tradeoff between the groundbreaking studies on brain function and the attempt to provide reliable biomarkers for clinical decisions is large. By describing some historical developments in the field of fMRI, from a personal view, the rise of this method in clinical neuroscience during the last 25 years might be understandable. We aim to provide some background for (a) the historical developments of fMRI, (b) the establishment of two research units for fMRI in the departments of radiology in Germany, and (c) a description of some contributions within the selected fields of systems neuroscience, clinical neurology, and behavioral psychology.

Optimizing home-based long-term intensive care for neurological patients with neurorehabilitation outreach teams - protocol of a multicenter, parallel-group randomized controlled trial (OptiNIV-Study).

BACKGROUND: Even with high standards of acute care and neurological early rehabilitation (NER) a substantial number of patients with neurological conditions still need mechanical ventilation and/or airway protection by tracheal cannulas when discharged and hence home-based specialised intensive care nursing (HSICN). It may be possible to improve the home care situation with structured specialized long-term neurorehabilitation support and following up patients with neurorehabilitation teams. Consequently, more people might recover over an extended period to a degree that they were no longer dependent on HSICN. METHODS: This healthcare project and clinical trial implements a new specialised neurorehabilitation outreach service for people being discharged from NER with the need for HSICN. The multicentre, open, parallel-group RCT compares the effects of one year post-discharge specialized outpatient follow-up to usual care in people receiving HSICN. Participants will randomly be assigned to receive the new form of healthcare (intervention) or the standard healthcare (control) on a 2:1 basis. Primary outcome is the rate of weaning from mechanical ventilation and/or decannulation (primary outcome) after one year, secondary outcomes include both clinical and economic measures. 173 participants are required to corroborate a difference of 30 vs. 10% weaning success rate statistically with 80% power at a 5% significance level allowing for 15% attrition. DISCUSSION: The OptiNIV-Study will implement a new specialised neurorehabilitation outreach service and will determine its weaning success rates, other clinical outcomes, and cost-effectiveness compared to usual care for people in need for mechanical ventilation and/or tracheal cannula and hence HSICN after discharge from NER. TRIAL REGISTRATION: The trial OptiNIV has been registered in the German Clinical Trials Register (DRKS) since 18.01.2022 with the ID DRKS00027326 .

[Rehabilitation with coronavirus disease with SARS-CoV-2 (COVID-19)]. / Rehabilitation bei Coronavirus-Erkrankung mit SARS-CoV-2 (COVID-19).

The Coronavirus disease with SARS-CoV-2 viral infection (COVID-19) and its diverse courses of disease from mild to critical illness frequently is not only an acute disease, but will - in a proportion of those affected - lead to organ structure and body function deficits that still exist or become apparent after the acute stage of disease. When clinically relevant symptoms or functional deficits (impairments) are documented more than four weeks after COVID-19 onset, the syndrome is called "Long-COVID", from 12 weeks after onset onwards "Post-COVID".In such cases and when everyday life functioning and return to work are affected by persisting deficits specialized rehabilitation treatment is indicated. An individual medical, frequently multi-professional diagnostic evaluation is mandatory in that situation: For adequate treatment, it is important to identify and objectify the individually underlying health conditions based on knowledge about the diverse potential consequences of COVID-19, to assess type and severity of functional consequences (impairments, activity limitations, and restrictions of participation) of Long-/Post-COVID individually, and then to decide on the treatment necessities and plans. With regard to rehabilitation, need and decision for either pulmonary, neurological, cardiac, or psychosomatic rehabilitation depends on the individual medical presentation.

[Rehabilitation with coronavirus disease with SARS-CoV-2 (COVID-19)]. / Rehabilitation bei Coronavirus-Erkrankung mit SARS-CoV-2 (COVID-19).

The Coronavirus disease with SARS-CoV-2 viral infection (COVID-19) and its diverse courses of disease from mild to critical illness frequently is not only an acute disease, but will - in a proportion of those affected - lead to organ structure and body function deficits that still exist or become apparent after the acute stage of disease. When clinically relevant symptoms or functional deficits (impairments) are documented more than four weeks after COVID-19 onset, the syndrome is called "Long-COVID", from 12 weeks after onset onwards "Post-COVID".In such cases and when everyday life functioning or return to work are affected by persisting deficits specialized rehabilitation treatment is indicated. An individual medical, frequently multi-professional diagnostic evaluation is mandatory in that situation: For adequate treatment, it is important to identify and objectify the individually underlying health conditions based on knowledge about the diverse potential consequences of COVID-19, to assess type and severity of functional consequences (impairments, activity limitations, and restrictions of participation) of Long-/Post-COVID individually, and then to decide on the treatment necessities and plans. With regard to rehabilitation, need and decision for either pulmonary, neurological, cardiac, or psychosomatic rehabilitation depends on the individual medical presentation.

[The certification of centers for weaning from mechanical ventilation in neurological and neurosurgical early rehabilitation by the German Society for Neurorehabilitation]. / Die Zertifizierung von Zentren für Beatmungsentwöhnung in der neurologisch-neurochirurgischen Frührehabilitation durch die Deutsche Gesellschaft für Neurorehabilitation.

Specialized centers for weaning in neurological and neurosurgical early rehabilitation can be certified by the German Society for Neurorehabilitation (DGNR) since 1 October 2021. The certification criteria are indicators for structure and process quality and for treatment results for weaning of neurological patients from mechanical ventilation. In Germany these patients are treated in departments for neurological and neurosurgical early rehabilitation in acute care hospitals as well as in specialized rehabilitation hospitals. Acknowledging this diversity of care, certification is possible for both kinds of institutions. Certification is granted by the DGNR in cooperation with TÜV Rheinland as the certification authority, analogous to the certification of stroke units. Institutions apply for certification by sending all necessary documents to the TÜV Rheinland. Afterwards auditors of the TÜV Rheinland (lead auditor) and the DGNR (medical speciality auditor) visit the institution on site. The results of this visit are reported to the certification committee of the DGNR, which in turn recommends or declines certification. The certification of centers for weaning in neurological and neurosurgical early rehabilitation is an important step towards defining neurorespiratory care and the role of the neurologist for intensive care and weaning in Germany. Thereby, the interdisciplinary dialogue between pneumologists, anesthesiologists, and neurologists is fostered. Also, the dialogue on treatment capacities and strategies with healthcare politicians, health insurances, and patient associations is facilitated.

[S1 Guideline Post-COVID/Long-COVID]. / S1-Leitlinie Post-COVID/Long-COVID.

The German Society of Pneumology initiated the AWMFS1 guideline Post-COVID/Long-COVID. In a broad interdisciplinary approach, this S1 guideline was designed based on the current state of knowledge.The clinical recommendation describes current post-COVID/long-COVID symptoms, diagnostic approaches, and therapies.In addition to the general and consensus introduction, a subject-specific approach was taken to summarize the current state of knowledge.The guideline has an expilcit practical claim and will be continuously developed and adapted by the author team based on the current increase in knowledge.

THERapy-Related InterACTion (THER-I-ACT) in Rehabilitation-Instrument Development and Inter-Rater Reliability.

Objective: To develop an instrument for the observation of therapeutic communication interactions during rehabilitation sessions and test its inter-rater reliability. Methods: The new instrument THER-I-ACT (THERapy-related Inter-ACTion) has been designed to assess both the frequency and timing of therapeutic interactions in the thematic fields information provision, feedback, other motivational interaction, and bonding. For this inter-rater reliability study, a sample of stroke survivors received arm rehabilitation as either arm ability training, arm basis training, or mirror therapy, or neglect training as individually indicated. Therapy sessions were video-recorded (one for each participant) and therapeutic interactions rated by two independent raters using THER-I-ACT. Results: With regard to the instrument's comprehensiveness to document therapeutic interactions with pre-defined categories the data from 29 sessions suggested almost complete coverage. Inter-rater reliability was very high both for individual categories of therapeutic interaction (frequency and time used for interaction) (intraclass correlation coefficient, ICC 0.91-1.00) and summary scores for the thematic fields of interaction (again for frequency and time used for interaction) (ICC 0.98-1.00). The inter-rater reliability for rating engagement and being focussed for both the therapist and patient was substantial (ICC 0.71 and 0.86). Conclusions: The observational study documented that by use of the newly designed THER-I-ACT various types of therapy-related communication interactions performed by therapists can be assessed with a very high inter-rater reliability. In addition, the thematic fields and categories of therapeutic interaction as defined by the instrument comprehensively covered the type of interaction that occurred in the therapeutic sessions observed.

Methods for the Development of Healthcare Practice Recommendations Using Systematic Reviews and Meta-Analyses.

Quality of healthcare can be improved when the best external evidence available is integrated in clinical decision-making in a systematic explicit manner. With the rapid expansion of clinical evidence, the opportunities for evidence-based high-quality healthcare increase. Paradoxically, the likelihood of any one person to get a complete and balanced picture of the evidence available decreases. This is especially true for rehabilitation interventions that are complex in nature and where clinical research is rather diverse. Given the complex nature of the evidence, there is a substantial risk of misinterpreting the complex information both at the level of individual sources (e.g., reports of clinical trials) and for aggregated data syntheses (e.g., systematic reviews and meta-analyses). These risks are inherent in these sources themselves and are in addition related to the methodological expertise necessary to make valid use of the evidence for clinical decision-making. Taken together, there is a great demand for systematic structured guidance from evidence to clinical decision. This methodology paper describes a structured process for the development and report of evidence-based clinical practice recommendations that uses systematic reviews and meta-analyses as evidence source. It provides a comprehensive framework with specific requirements for the development group, the formulation of the healthcare question addressed, the systematic search for the evidence, its critical appraisal, the extraction and the outcome-centered presentation of the evidence, the rating of its quality, strengths and weaknesses, any further considerations relevant for decision-making, and an explicit recommendation statement along with its justification, implementation, and resource aspects. The suggested methodology uses international standards in evidence synthesis, critical appraisal of systematic reviews, rating the quality of evidence, characteristics of recommendations, and guideline development as developed by Cochrane, GRADE (Grading of Recommendations Assessment, Development and Evaluation), AMSTAR (A MeaSurement Tool to Assess systematic Reviews), and AGREE (Appraisal of Guidelines for REsearch & Evaluation). An added distinctive feature of the methodology is to focus on the most up-to-date, most valid evidence and hence to support the development of valid practice recommendations in an efficient way. Practice recommendations generated by such a valid methodology would be generally applicable and promote evidence-based clinical practice globally.

Telemedicine and Virtual Reality at Time of COVID-19 Pandemic: An Overview for Future Perspectives in Neurorehabilitation.

In catastrophic situations such as pandemics, patients' healthcare including admissions to hospitals and emergency services are challenged by the risk of infection and by limitations of healthcare resources. In such a setting, the use of telemedicine interventions has become extremely important. New technologies have proved helpful in pandemics as a solution to improve the quality of life in vulnerable patients such as persons with neurological diseases. Moreover, telemedicine interventions provide at-home solutions allowing clinicians to telemonitor and assess patients remotely, thus minimizing risk of infection. After a review of different studies using telemedicine in neurological patients, we propose a telemedicine process flow for healthcare of subjects with chronic neurological disease to respond to the new challenges for delivering quality healthcare during the transformation of public and private healthcare organizations around the world forced by COVID-19 pandemic contingency. This telemedicine process flow represents a replacement for in-person treatment and thereby the provision equitable access to the care of vulnerable people. It is conceptualized as comprehensive service including (1) teleassistance with patient counseling and medical treatment, (2) telemonitoring of patients' health conditions and any changes over time, as well as (3) telerehabilitation, i.e., interventions to assess and promote body functions, activities, and consecutively participation. The hereby proposed telemedicine process flow could be adopted on a large scale to improve the public health response during healthcare crises like the COVID-19 pandemic but could equally promote equitable health care independent of people's mobility or location with respect to the specialized health care center.

[Evidence-based Practice Guidelines for the German Society for Neurology (DGN) and the German Society for Neurorehabilitation (DGNR): Methods for systematic evidence-to-decision process]. / Evidenzbasierte Leitlinienentwicklung der Deutschen Gesellschaft für Neurologie (DGN) und der Deutschen Gesellschaft für Neurorehabilitation (DGNR) - Methodik für die systematische Evidenzbasierung.

Evidence-based guidelines of high quality, which are prepared either by a scientific medical association (S2e guidelines) or by an interdisciplinary group of different medical associations (S3 guidelines), represent a combination of the best available external evidence (from clinical trials) and the recommendations derived from it for clinical practice. In the case of an interdisciplinary development, the recommendations are also formally agreed upon in a structured consensus process. They thus generate a high degree of certainty for clinicians that the state of the art is adequately taken into account in their decisions. Based on the guideline development methodology of the Association of Scientific Medical Societies (AWMF), the DGN and DGNR have agreed on standards for the implementation of the guideline development methodology for the evidence-based development of their guidelines, which are documented here. They make it clear to readers and users of evidence-based guidelines which content-related and methodological aspects have to be taken into account if practice recommendations are to be derived from and based on data available from clinical studies.

[Weaning in neurological and neurosurgical early rehabilitation-Results from the "WennFrüh" study of the German Society for Neurorehabilitation]. / Weaning in der neurologisch-neurochirurgischen Frührehabilitation ­ Ergebnisse der "WennFrüh"-Studie der Deutschen Gesellschaft für Neurorehabilitation.

Neurological and neurosurgical early rehabilitation patients are often so critically ill that they must be weaned from mechanical ventilation in addition to early rehabilitative treatment. The German Society for Neurorehabilitation (DGNR) carried out a survey and asked neurological weaning units to provide information on structural characteristics of the facility, including personnel and technical resources and the number of cases and outcome based on anonymous data. In total 36 weaning units from 11 federal states with a total of 496 beds participated in the survey. From 2516 weaning cases documented in 2019, 2097 (83.3%) could primarily be successfully weaned from mechanical ventilation and only 120 (4.8%) had to be discharged with home ventilation. The mortality in this sample was 11.0% (n = 276). The results of the survey demonstrate that prolonged weaning during early neurological and neurosurgical rehabilitation is an important and effective component of healthcare provision for critically ill patients in Germany.