O. Busse

Assessment of Functioning and Disability After Ischemic Stroke

Background and Purpose— Functioning and disability after ischemic stroke are clinically meaningful and of major relevance to patients. Despite many instruments available to assess these outcomes, little is known about their interrelation and predictive factors. Methods— We prospectively identified 4264 patients with acute ischemic stroke from 30 hospitals in Germany during a 1-year period between 1998 and 1999 and registered them in a common data bank. The patients were centrally followed up via telephone interview after 100 days and 1 year to assess various scales such as the Barthel Index (BI), modified Rankin Scale (MRS), extended Barthel Index (EBI), Short Form-36 Physical Functioning (SF-36 PF), and Center for Epidemiologic Studies–Depression short form (CES-D). Results— Outcome status could be assessed in 67.2% of patients 100 days after hospital admission. Of these, 13.9% had died, 53.7% had regained functional independence (BI <95), 46.3% had no or mild residual symptoms (MRS ≤1), and 44.6% had no higher cognitive deficits on the EBI. Of the patients who personally answered the follow-up questions, 67% had no major physical disability (SF-36 PF <60), and 32.9% reported symptoms classified as depression (CES-D ≥10). The high percentage of patients reaching the maximum score (ceiling effect) in the BI was less pronounced in the MRS and SF-36 PF. The predictive factors for dichotomized outcomes on each scale were similar for adverse functioning and disability but varied considerably for depression. Conclusions— To avoid ceiling effects in outcome distribution of patients treated in specialized stroke centers, the MRS and SF-36 PF instruments are preferable to the BI. Parametric use of the SF-36 PF could further improve outcome measurement by considering individual treatment effects.

Development and Implementation of Evidence-Based Indicators for Measuring Quality of Acute Stroke Care The Quality Indicator Board of the German Stroke Registers Study Group (ADSR)

Background and Purpose— There is no consensus about indicators for measuring quality of acute stroke care in Germany. Therefore, a standardized process was initiated recently to develop and implement evidence-based indicators for the measurement of quality of acute hospital stroke care. Methods— Quality indicators were developed by a multidisciplinary board between November 2003 and December 2005. The process was initiated by the German Stroke Registers Study Group in cooperation with the German Stroke Society, the German Society of Neurology, the German Stroke Foundation, Regional Offices for Quality Assurance and other experts proven in the field. National and international recommendations were considered during the development process. The process was based on a systematic literature review, an independent external evaluation of the process and its results, and a prospective pilot study to evaluate the defined indicators in clinical practice. Results— Overall a set of 24 indicators was developed to measure performance of acute care hospitals in the 3 health care dimensions structure, process and outcome as well as in 3 treatment phases prehospital, in-hospital/acute and postacute. Practicability of the derived indicators was tested in a prospective pilot study. During a 2-month period, 1006 patients in 13 hospitals were documented. Application of the new indicator set was found to be feasible by participating physicians and hospitals. Median time to document the required information for 1 patient was 5 minutes. Nationwide implementation of the new indicator set within regional registers in Germany started since April 2006. Conclusions— The development of indicators to measure hospital performance in stroke care is an important step toward improving stroke care on a national level. The chosen standardized evidence-based approach ensures maximal transparency, acceptance and sustainability of the developed indicators in Germany.

The quality of acute stroke care- an analysis of evidence-based indicators in 260 000 patients.

BACKGROUNDnStroke patients should be cared for in accordance with evidence-based guidelines. The extent of implementation of guidelines for the acute care of stroke patients in Germany has been unclear to date.nnnMETHODSnThe regional quality assurance projects that cooperate in the framework of the German Stroke Registers Study Group (Arbeitsgemeinschaft Deutscher Schlaganfall-Register, ADSR) collected data on the care of stroke patients in 627 hospitals in 2012. The quality of the acute hospital care of patients with stroke or transient ischemic attack (TIA) was assessed on the basis of 15 standardized, evidence-based quality indicators and compared across the nine participating regional quality assurance projects.nnnRESULTSnData were obtained on more than 260 000 patients nationwide. Intravenous thrombolysis was performed in 59.7% of eligible ischemic stroke patients patients (range among participating projects, 49.7-63.6%). Dysphagia screening was documented in 86.2% (range, 74.8-93.1%). For the following indicators, the defined targets were not reached for all of Germany: anti-aggregation within 48 hours, 93.4% (range, 86.6-96.4%); anticoagulation for atrial fibrillation, 77.6% (range, 72.4-80.1%); standardized dysphagia screening, 86.2% (range, 74.8-93.1%); oral and written information of the patients or their relatives, 86.1% (range, 75.4-91.5%). The rate of patients examined or treated by a speech therapist was in the target range.nnnCONCLUSIONnThe defined targets were reached for most of the quality indicators. Some indicators, however, varied widely across regional quality assurance projects. This implies that the standardization of care for stroke patients in Germany has not yet been fully achieved.

Diagnostic Work-Up for Detection of Paroxysmal Atrial Fibrillation After Acute Ischemic Stroke Cross-Sectional Survey on German Stroke Units

Background and Purpose— Multiple methods to detect paroxysmal atrial fibrillation (pAF) in patients with acute stroke are available. However, it is unknown which approaches are currently used in clinical routine and guidelines remain vague to the extent of cardiac monitoring. We characterize diagnostic efforts for pAF detection on German stroke units (SU). Methods— A standardized anonymous questionnaire was sent to all clinical leads of certified SUs in Germany. The questionnaire focused on basic characteristics of SUs, procedures to detect AF, and estimates on AF detection. Results— One hundred seventy-nine SU leads participated (response rate 71.6%). All patients undergo continuous bedside ECG monitoring. A percentage of 77.6 SUs initiate additional 24-hour Holter ECG in >50% of patients without known AF. Patients with transient ischemic attack are monitored significantly shorter than patients with ischemic stroke. Independent of SU type or size, 67.6% of leads assumed to fail detecting pAF in 5% to 20% of patients. In cryptogenic stroke, additional ECG monitoring is recommended by 90.2% but only 13.8% of SUs perform routine ECG follow-up visits. The use of implanted event recorders is low (1–10 patients/y by 60.7% of SUs; 28.1%: no use). A percentage of 83.9 do not use external event recorders. Conclusions— Our survey demonstrates substantial heterogeneity among German SUs on diagnostic work-up for pAF. Future prospective multicenter studies should systematically evaluate the impact of different methods to uncover pAF.

Impact of standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke (MonDAFIS): Rationale and design of a prospective randomized multicenter study

BACKGROUNDnAtrial fibrillation (AF) is estimated to account for approximately every fifth ischemic stroke. In routine clinical practice, detection of undiagnosed, clinically silent AF represents a major diagnostic challenge, and in up to 30% of patients with ischemic stroke, AF remains undetected. The MonDAFIS study has been designed to quantify the diagnostic yield and clinical relevance of systematic electrocardiogram (ECG) monitoring for patients with acute ischemic stroke during the subsequent in hospital stay.nnnSTUDY DESIGNnA prospective randomized multicenter study in 3,470 patients with acute ischemic stroke or transient ischemic attack and without known AF on hospital admission. Over a period of approximately 2years, patients will be enrolled in about 30 German-certified stroke units and randomized 1:1 to receive either usual stroke unit diagnostic procedures for detection of AF (control group) or usual stroke unit diagnostic procedures plus standardized and centrally analyzed Holter ECG recording for up to 7days in hospital (intervention group). Results of the ECG core laboratory analysis will be provided to the patients and treating physicians. All patients will be followed up for treatment and cardiovascular outcomes at 6, 12, and 24months after enrollment.nnnOUTCOMESnThe primary outcome of the randomized MonDAFIS study is the proportion of patients who receive anticoagulation therapy 12months after the index stroke. Secondary outcomes include the number of stroke patients with newly detected AF in hospital and the rate of recurrent stroke, major bleedings, myocardial infarction, or death 6, 12, and 24months after the index event. MonDAFIS will also explore patient-reported adherence to anticoagulants, the clinical relevance of short atrial tachycardia, or excessive supraventricular ectopic activity as well as cost-effectiveness of prolonged, centrally analyzed ECG recordings.nnnCONCLUSIONnMonDAFIS will be the largest study to date to evaluate whether a prolonged and systematic ECG monitoring during the initial in hospital stay has an impact on secondary stroke prevention. In addition, prognosis as well as adherence to medication up to 2 years after the index stroke will be analyzed. The primary results of the MonDAFIS study may have the potential to change the current guidelines recommendations regarding ECG workup after ischemic stroke.

Regionale und überregionale Stroke-Units in Deutschland

Stroke units (SU) have been certified for many years by the German Stroke Society (DSG) and the German Stroke Aid Foundation (SDSH). Since 2009 this is now undertaken in the third generation by the LGA InterCert of the Technical Surveillance Society of Rhineland (TÜV Rheinland). This article presents the amended certification criteria which came into effect in 2012. Many criteria and definitions could be further defined and specified and residual grey areas and fields of conflict could be reduced. For the first time a distinction has been made between the minimum requirements relevant for certification and additional recommendations by the SU Commission of the DSG. In this manner the authors are aiming to motivate SU operators not just to align quality assurance measures to the minimum requirements but to deliberately go beyond them. There is a great deal of evidence to indicate that this will not only serve to increase the motivation of personnel and the quality of treatment but simultaneously the economic situation can also be improved.ZusammenfassungStroke-Units (SU) werden seit vielen Jahren durch die Deutsche Schlaganfallgesellschaft (DSG) und die Stiftung Deutsche Schlaganfall-Hilfe (SDSH) zertifiziert. Seit dem Jahre 2009 erfolgt dies in nunmehr 3.xa0Generation mit der LGA InterCert des TÜV Rheinland. Mit der vorliegenden Arbeit werden die aktualisierten Zertifizierungskriterien vorgestellt, die ab dem Jahre 2012 gültig sein werden. Es konnten zahlreiche Kriterien und Definitionen weiter konkretisiert, präzisiert und verbliebene Grauzonen und Konfliktfelder reduziert werden. Auch wurde erstmals eine Trennung vorgenommen zwischen zertifizierungsrelevanten Minimalanforderungen und zusätzlichen Empfehlungen der SU-Kommission der DSG. Die Autoren möchten die SU-Betreiber auf diesem Wege ausdrücklich dazu motivieren, die Qualitätsmaßnahmen nicht an den Mindestanforderungen auszurichten, sondern gezielt darüber hinauszugehen. Zahlreiche Evidenzen sprechen dafür, dass dadurch nicht nur die Motivation des Personals und die Behandlungsqualität gesteigert, sondern gleichsam auch die ökonomische Situation verbessert werden kann.SummaryStroke units (SU) have been certified for many years by the German Stroke Society (DSG) and the German Stroke Aid Foundation (SDSH). Since 2009 this is now undertaken in the third generation by the LGA InterCert of the Technical Surveillance Society of Rhineland (TÜV Rheinland). This article presents the amended certification criteria which came into effect in 2012. Many criteria and definitions could be further defined and specified and residual grey areas and fields of conflict could be reduced. For the first time a distinction has been made between the minimum requirements relevant for certification and additional recommendations by the SU Commission of the DSG. In this manner the authors are aiming to motivate SU operators not just to align quality assurance measures to the minimum requirements but to deliberately go beyond them. There is a great deal of evidence to indicate that this will not only serve to increase the motivation of personnel and the quality of treatment but simultaneously the economic situation can also be improved.

Behandlung des ischämischen Schlaganfalls in 14 neurologischen Stroke Units

ZusammenfassungDie vorliegende Studie vergleicht anhand von 3740 Patienten mit akutem ischämischen Schlaganfall die Versorgung in 14 etablierten neurologischen Stroke Units. Durch Nachbefragungen der Patienten nach 3 Monaten wurden außerdem die funktionelle Restitution sowie die Modifikation der Risikofaktoren erhoben. Der Altersmedian aller Patienten lag bei 68 Jahren, und 41,9% waren Frauen. 26% aller Patienten wurden innerhalb von 3 Stunden nach Ereignis aufgenommen, und 4,2% wurden systemisch lysiert. Die mediane Liegedauer aller Patienten auf der Stroke Unit lag bei 3 Tagen, wobei 63% anschließend auf eine andere Station der dokumentierenden Klinik verlegt wurden. Die mittlere Gesamtliegedauer in der dokumentierenden Klinik lag bei 12 Tagen. In 7 Zentren mit einer Vollständigkeit der Nachbefragung >80% waren nach 3 Monaten 10,5% aller Patienten verstorben und 56,2% funktionell unabhängig.Die vorliegende Untersuchung zeigt die relativ gute Prognose von Patienten in neurologischen Stroke Units sowie die noch geringe Standardisierung der diagnostischen Abklärung und Behandlung.SummaryThis study compares the treatment characteristics of 3,740 patients with acute ischemic stroke in 14 established German stroke units. Follow-up after 3 months in surviving patients additionally assessed functional outcome and risk factor modification. The median age was 68 years and 41.9% were women. Twenty-six percent of all patients were admitted within 3 h after the event, and 4.2% received systemic thrombolysis. The median length of stay of all patients in the stroke unit was 3 days. Thereafter, 63% were transferred to another ward in the documenting clinic. The mean length of stay in the documenting hospital was 12 days. In seven hospitals with a follow-up rate of >80%, mortality amounted to 10.5%, and 56.2% of the patients regained functional independence. This study demonstrates the relatively favorable prognosis of patients in German stroke units as well as the low standardization of diagnostic work-up and treatment strategies.

[Regional and national stroke units in Germany: amended certification criteria].

Stroke units (SU) have been certified for many years by the German Stroke Society (DSG) and the German Stroke Aid Foundation (SDSH). Since 2009 this is now undertaken in the third generation by the LGA InterCert of the Technical Surveillance Society of Rhineland (TÜV Rheinland). This article presents the amended certification criteria which came into effect in 2012. Many criteria and definitions could be further defined and specified and residual grey areas and fields of conflict could be reduced. For the first time a distinction has been made between the minimum requirements relevant for certification and additional recommendations by the SU Commission of the DSG. In this manner the authors are aiming to motivate SU operators not just to align quality assurance measures to the minimum requirements but to deliberately go beyond them. There is a great deal of evidence to indicate that this will not only serve to increase the motivation of personnel and the quality of treatment but simultaneously the economic situation can also be improved.ZusammenfassungStroke-Units (SU) werden seit vielen Jahren durch die Deutsche Schlaganfallgesellschaft (DSG) und die Stiftung Deutsche Schlaganfall-Hilfe (SDSH) zertifiziert. Seit dem Jahre 2009 erfolgt dies in nunmehr 3.xa0Generation mit der LGA InterCert des TÜV Rheinland. Mit der vorliegenden Arbeit werden die aktualisierten Zertifizierungskriterien vorgestellt, die ab dem Jahre 2012 gültig sein werden. Es konnten zahlreiche Kriterien und Definitionen weiter konkretisiert, präzisiert und verbliebene Grauzonen und Konfliktfelder reduziert werden. Auch wurde erstmals eine Trennung vorgenommen zwischen zertifizierungsrelevanten Minimalanforderungen und zusätzlichen Empfehlungen der SU-Kommission der DSG. Die Autoren möchten die SU-Betreiber auf diesem Wege ausdrücklich dazu motivieren, die Qualitätsmaßnahmen nicht an den Mindestanforderungen auszurichten, sondern gezielt darüber hinauszugehen. Zahlreiche Evidenzen sprechen dafür, dass dadurch nicht nur die Motivation des Personals und die Behandlungsqualität gesteigert, sondern gleichsam auch die ökonomische Situation verbessert werden kann.SummaryStroke units (SU) have been certified for many years by the German Stroke Society (DSG) and the German Stroke Aid Foundation (SDSH). Since 2009 this is now undertaken in the third generation by the LGA InterCert of the Technical Surveillance Society of Rhineland (TÜV Rheinland). This article presents the amended certification criteria which came into effect in 2012. Many criteria and definitions could be further defined and specified and residual grey areas and fields of conflict could be reduced. For the first time a distinction has been made between the minimum requirements relevant for certification and additional recommendations by the SU Commission of the DSG. In this manner the authors are aiming to motivate SU operators not just to align quality assurance measures to the minimum requirements but to deliberately go beyond them. There is a great deal of evidence to indicate that this will not only serve to increase the motivation of personnel and the quality of treatment but simultaneously the economic situation can also be improved.

Erweiterte Stroke-Unit

ZusammenfassungDas Konzept der „Erweiterten Stroke-Unit“ beschreibt eine zusätzliche strukturelle Option für bereits zertifizierte Stroke-Units mit dem Ziel, die stark akuttherapeutisch ausgerichtete Behandlung der Schlaganfallpatienten auf deutschen Stroke-Units in stärkerem Maße durch frühe Mobilisationsbehandlung und neuropsychologische Rehabilitationsmaßnahmen zu ergänzen. Dieses Konzept wird in vielen europäischen Ländern empfohlen. Hintergrund dafür ist die auf höchstem Evidenzlevel nachgewiesene Wirksamkeit dieses kombinierten Behandlungspaketes in mehreren randomisierten Studien. Entsprechend den Forderungen der Helsingborg Deklaration soll dem Schlaganfallpatienten eine kontinuierliche Behandlungskette zur Verfügung stehen. In der Erweiterten Stroke-Unit kann die initial eingeleitete, frühe Mobilisations- und Rehabilitationsbehandlung ohne Unterbrechung fortgeführt werden. Dadurch wird eine Schnittstelle zwischen der bisherigen Stroke-Unit und der Allgemeinstation beseitigt. Die nichtmonitorisierten „Enhanced-Care-Betten“ und die Monitorbetten sind deshalb in ein- und derselben räumlichen Einheit lokalisiert. Die Weiterversorgung eines akuten Schlaganfallpatienten durch dasselbe Team auf derselben Stroke-Unit bedeutet einen Qualitäts- und Zeitgewinn und eine bessere Nutzung der Personalressourcen. Die dem Konzept zugrunde liegenden wissenschaftlichen Hintergründe und seine Vorteile werden dargestellt, ebenso die strukturellen und personellen Voraussetzungen. Die für Enhanced-Care-Betten besonders geeignete Klientel wird beschrieben und das Leistungsspektrum des Behandlungsteams definiert. Das vorliegende Konzept soll Grundlage einer optionalen Zusatzzertifizierung bereits zertifizierter Stroke-Units werden. Eine wichtige Aufgabe bestand darin, das Konzept so zu gestalten, dass es sich zwanglos in die bereits bestehende Infrastruktur der zertifizierten Regionalen oder Überregionalen Stroke-Units einfügt. Unter ökonomischen Gesichtspunkten kann eine Erweiterte Stroke-Unit voraussichtlich kostenneutral oder mit einem Plus betrieben werden.SummaryThe concept of a „comprehensive stroke unit“ (in German: Erweiterte Stroke-Unit) is an additional structural option for those stroke units already certified in Germany. Its aim is to complement the semi-intensive management of stroke unit patients in Germany by early mobilisation and neuropsychological rehab procedures. This concept is recommended in many European countries as well. It is based on the proof of efficacy of the combined treatment package in several randomised controlled trials. According to the Helsingborg Declaration, every stroke patient in Europe should have access to a chain of care best provided by a comprehensive stroke unit. Both early mobilisation and rehabilitation treatment can be integrated and continued without creating an interface between the acute stroke unit and the general neurological or medical ward. The monitoring beds of the acute stroke unit and the non-monitoring „enhanced care“ beds are located within the same geographical area of the hospital and are run as a comprehensive stroke care entity. Continuous management of the acute stroke patients by the same team on the same unit means an increase in quality of care, better usage of staff resources and an additional gain in time. The scientific background of the advantages of a comprehensive stroke unit is described as are the structural and staff requirements. The clientel particularly benefiting from treatment on wards with enhanced care beds is described, and the spectrum of treatment services is defined. This concept will be used as the basis for an add-on qualification of already certified German stroke units. An important step was to fit the requirements of the comprehensive stroke unit to the already existing facilities and their infrastructures. From an economic point of view, the comprehensive stroke unit is expected to be cost-effective, either balanced or even positive.The concept of a comprehensive stroke unit (in German: Erweiterte Stroke-Unit) is an additional structural option for those stroke units already certified in Germany. Its aim is to complement the semi-intensive management of stroke unit patients in Germany by early mobilisation and neuropsychological rehab procedures. This concept is recommended in many European countries as well. It is based on the proof of efficacy of the combined treatment package in several randomised controlled trials. According to the Helsingborg Declaration, every stroke patient in Europe should have access to a chain of care best provided by a comprehensive stroke unit. Both early mobilisation and rehabilitation treatment can be integrated and continued without creating an interface between the acute stroke unit and the general neurological or medical ward. The monitoring beds of the acute stroke unit and the non-monitoring enhanced care beds are located within the same geographical area of the hospital and are run as a comprehensive stroke care entity. Continuous management of the acute stroke patients by the same team on the same unit means an increase in quality of care, better usage of staff resources and an additional gain in time. The scientific background of the advantages of a comprehensive stroke unit is described as are the structural and staff requirements. The clientel particularly benefiting from treatment on wards with enhanced care beds is described, and the spectrum of treatment services is defined. This concept will be used as the basis for an add-on qualification of already certified German stroke units. An important step was to fit the requirements of the comprehensive stroke unit to the already existing facilities and their infrastructures. From an economic point of view, the comprehensive stroke unit is expected to be cost-effective, either balanced or even positive.

Stroke unit care in germany: The german stroke registers study group (ADSR)

BackgroundFactors influencing access to stroke unit (SU) care and data on quality of SU care in Germany are scarce. We investigated characteristics of patients directly admitted to a SU as well as patient-related and structural factors influencing adherence to predefined indicators of quality of acute stroke care across hospitals providing SU care.MethodsData were derived from the German Stroke Registers Study Group (ADSR), a voluntary network of 9 regional registers for monitoring quality of acute stroke care in Germany. Multivariable logistic regression analyses were performed to investigate characteristics influencing direct admission to SU. Generalized Linear Mixed Models (GLMM) were used to estimate the influence of structural hospital characteristics (percentage of patients admitted to SU, year of SU-certification, and number of stroke and TIA patients treated per year) on adherence to predefined quality indicators.ResultsIn 2012 180,887 patients were treated in 255 hospitals providing certified SU care participating within the ADSR were included in the analysis; of those 82.4% were directly admitted to a SU. Ischemic stroke patients without disturbances of consciousness (pu2009<u2009.0001), an interval onset to admission time ≤3 h (pu2009<u2009.0001), and weekend admission (pu2009<u2009.0001) were more likely to be directly admitted to a SU. A higher proportion of quality indicators within predefined target ranges were achieved in hospitals with a higher proportion of SU admission (pu2009=u20090.0002). Quality of stroke care could be maintained even if certification was several years ago.ConclusionsDifferences in demographical and clinical characteristics regarding the probability of SU admission were observed. The influence of structural characteristics on adherence to evidence-based quality indicators was low.