Development and pilot-testing of an evidence-based quality indicator set for home mechanical ventilation care: the OVER-BEAS project.

BACKGROUND: The number of patients depending on home mechanical ventilation (HMV) has increased substantially in Germany in recent years. These patients receive long-term care in different nursing facilities (nursing home, shared living community, private home). However, there are limited data available on the quality of care of HMV patients. The aim of the OVER-BEAS project was to identify quality indicators (QIs) of HMV care using an evidence-based approach. METHODS: A multidisciplinary board consisting of professionals and experts of HMV provision compiled a set of QIs between March and September 2019. In a structured, transparent process a set of QIs covering structures, processes and outcome of HMV patient's care were proposed and evaluated based on the best available evidence. QIs were defined as relevant, reliable and valid measurements of the quality of HMV care and furthermore to be comprehensive and applicable in practice. RESULTS: The experts proposed 40 QIs and consented a final set of 26 QIs. Based on the final set, questionnaires to document the QIs were developed: (1) to assess the quality and describe the structure of the nursing facility; and (2) to gather information on patient-related processes and outcomes. The feasibility of the questionnaires was tested in 5 nursing facilities treating HMV patients. The remarks from the nursing specialists were categorised in three groups: (1) term missing accuracy, (2) problem of understanding, and (3) not documented or documented elsewhere. Mean documentation time by the nursing specialists for one patient was 15 min. Based on this feedback, the questionnaires were finalised. CONCLUSIONS: We proposed a set of QIs relating to long-term HMV care and developed two questionnaires to collect this information. In a pilot study, we found the set of questionnaires to be feasible in assessing the quality of HMV care according to current evidence. The development of standardised evidence-based QIs to evaluate HMV care is a step towards implementing a standardised quality assurance program to document the quality of care of HMV patients.

Ethical and coordinative challenges in setting up a national cohort study during the COVID-19 pandemic in Germany.

With the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), global researchers were confronted with major challenges. The German National Pandemic Cohort Network (NAPKON) was launched in fall 2020 to effectively leverage resources and bundle research activities in the fight against the coronavirus disease 2019 (COVID-19) pandemic. We analyzed the setup phase of NAPKON as an example for multicenter studies in Germany, highlighting challenges and optimization potential in connecting 59 university and nonuniversity study sites. We examined the ethics application process of 121 ethics submissions considering durations, annotations, and outcomes. Study site activation and recruitment processes were investigated and related to the incidence of SARS-CoV-2 infections. For all initial ethics applications, the median time to a positive ethics vote was less than two weeks and 30 of these study sites (65%) joined NAPKON within less than three weeks each. Electronic instead of postal ethics submission (9.5 days (Q1: 5.75, Q3: 17) vs. 14 days (Q1: 11, Q3: 26), p value = 0.01) and adoption of the primary ethics vote significantly accelerated the ethics application process. Each study center enrolled a median of 37 patients during the 14-month observation period, with large differences depending on the health sector. We found a positive correlation between recruitment performance and COVID-19 incidence as well as hospitalization incidence. Our analysis highlighted the challenges and opportunities of the federated system in Germany. Digital ethics application tools, adoption of a primary ethics vote and standardized formal requirements lead to harmonized and thus faster study initiation processes during a pandemic.

Effect of the addition of a mental health specialist for evaluation of undiagnosed patients in centres for rare diseases (ZSE-DUO): a prospective, controlled trial with a two-phase cohort design.

Background: People with complex symptomatology but unclear diagnosis presenting to a centre for rare diseases (CRD) may present with mental (co-)morbidity. We hypothesised that combining an expert in somatic medicine with a mental health specialist working in tandem will improve the diagnostic outcome. Methods: Patients aged 12 years and older who presented to one of the 11 participating German CRDs with an unknown diagnosis were recruited into this prospective cohort trial with a two-phase cohort design. From October 1, 2018 to September 30, 2019, participants were allocated to standard care (SC, N = 684), and from October 1, 2019 to January 31, 2021 to innovative care (IC, N = 695). The cohorts consisted mainly of adult participants with only a minority of children included (N = 67). IC included the involvement of a mental health specialist in all aspects of care (e.g., assessing medical records, clinic visits, telehealth care, and case conferences). Clinicaltrials.gov identifier: NCT03563677. Findings: The proportion of patients with diagnoses established within 12 months after the first visit to the CRD explaining the entire symptomatology (primary outcome) was 19% (N = 131 of 672) in the SC and 42% (N = 286 of 686) in the IC cohort (OR adjusted for centre effects 3.45 [95% CrI: 1.99-5.65]). The difference was mainly due to a higher prevalence of mental disorders and non-rare somatic diseases in the IC cohort. The median time to explaining diagnoses was one month shorter with IC (95% CrI: 1-2), and significantly more patients could be referred to local regular care in the IC (27.5%; N = 181 of 659) compared to the SC (12.3%; N = 81 of 658) cohort (OR adjusted for centre effects 2.70 [95% CrI: 2.02-3.60]). At 12-month follow-up, patient satisfaction with care was significantly higher in the IC compared to the SC cohort, while quality of life was not different between cohorts. Interpretation: Our findings suggested that including a mental health specialist in the entire evaluation process of CRDs for undiagnosed adolescents and adults should become an integral part of the assessment of individuals with a suspected rare disease. Funding: The study was funded by the Global Innovation Fund from the Joint Federal Committee in Germany (Innovationsfonds des Gemeinsamen Bundesausschusses), grant number 01NVF17031.

Prospective single-center study of health-related quality of life after COVID-19 in ICU and non-ICU patients.

Long-term sequelae in hospitalized Coronavirus Disease 2019 (COVID-19) patients may result in limited quality of life. The current study aimed to determine health-related quality of life (HRQoL) after COVID-19 hospitalization in non-intensive care unit (ICU) and ICU patients. This is a single-center study at the University Hospital of Wuerzburg, Germany. Patients eligible were hospitalized with COVID-19 between March 2020 and December 2020. Patients were interviewed 3 and 12 months after hospital discharge. Questionnaires included the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L), patient health questionnaire-9 (PHQ-9), the generalized anxiety disorder 7 scale (GAD-7), FACIT fatigue scale, perceived stress scale (PSS-10) and posttraumatic symptom scale 10 (PTSS-10). 85 patients were included in the study. The EQ5D-5L-Index significantly differed between non-ICU (0.78 ± 0.33 and 0.84 ± 0.23) and ICU (0.71 ± 0.27; 0.74 ± 0.2) patients after 3- and 12-months. Of non-ICU 87% and 80% of ICU survivors lived at home without support after 12 months. One-third of ICU and half of the non-ICU patients returned to work. A higher percentage of ICU patients was limited in their activities of daily living compared to non-ICU patients. Depression and fatigue were present in one fifth of the ICU patients. Stress levels remained high with only 24% of non-ICU and 3% of ICU patients (p = 0.0186) having low perceived stress. Posttraumatic symptoms were present in 5% of non-ICU and 10% of ICU patients. HRQoL is limited in COVID-19 ICU patients 3- and 12-months post COVID-19 hospitalization, with significantly less improvement at 12-months compared to non-ICU patients. Mental disorders were common highlighting the complexity of post-COVID-19 symptoms as well as the necessity to educate patients and primary care providers about monitoring mental well-being post COVID-19.

Systematic review with meta-analysis: Stress-management interventions for patients with irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a common chronic gastrointestinal disorder of unknown pathological origin that is associated with psychological distress and reduced health-related quality of life (HRQoL). We investigated the effects of stress-management for adults with IBS on typical symptoms, HRQoL and mental health. With predefined criteria (patients: adults with IBS; intervention: stress-management; control: care as usual or waitlist; outcome: patient-relevant; study-type: controlled trials), we registered the study with PROSPERO (168030) and searched the main medical databases. Two researchers independently reviewed the publications and assessed the risk of bias using the Scottish Intercollegiate Guidelines Network checklist. We performed meta-analysis with homogeneous trials of acceptable quality. After screening 6656 publications, ten suitable randomized trials of acceptable (n = 5) or low methodological quality (n = 5) involving 587 patients were identified. Our meta-analysis showed no effect of stress-management on IBS severity 1-2 months after the intervention (Hedges' g = -0.23, 95%-CI = -0.84 to -0.38, I2  = 86.1%), and after 3-12 months (Hedges' g = -0.77, 95%-CI = -1.77 to -0.23, I2  = 93.3%). One trial found a short-term reduction of symptoms, and one trial found symptom relief in the long-term (at 6 months). One of two studies that examined HRQoL found an improvement (after 2 months). One of two studies that examined depression and anxiety found a reduction of these symptoms (after 3 weeks). Stress-management may be beneficial for patients with IBS regarding the short-term reduction of bowel and mental health symptoms, whereas long-term benefits are unclear. Good quality RCTs with more than 6 months follow-up are needed.

[Complexity of outpatient intensive care for ventilated people: Cross-mapping into the standardised NNN-taxonomy]. / Komplexität außerstationärer Intensivpflege beatmeter Menschen.

Complexity of outpatient intensive care for ventilated people: Cross-mapping into the standardised NNN-taxonomy Abstract. Background: In Germany, free text is the preferred method for recording the nursing process in outpatient intensive care, although classification systems could enable a more precise description. Research question: How is nursing care for people with outpatient ventilation represented by the NNN-taxonomy and what are the recommendations for nursing practice? Methods: A qualitative "multiple case" design was applied. Using deductive content analysis (data sources: nursing documentation and secondary analysis of interviews with affected persons), several cases, both individually and across all cases were linked to the NNN-taxonomy (cross-mapping). Results: In total, the nursing documentation of 16 invasively ventilated persons with a mean age of 58.4 years (SD = 16.3) was analysed. Seven persons additionally contributed interview data. Documentation was mainly based on the "Strukturmodell" (14/16) with a moderate to high accuracy (D-Catch Score: 16.6; SD = 4.1). Cross-mapping resulted in 4016 codes: 618 nursing diagnoses, 1956 interventions and 1442 outcomes. Documentation was strongly measure-oriented, not very person-centred and with a lack of differentiation between diagnosis and intervention. Conclusions: To improve nursing practice, a person-centred attitude and the ability to differentiate between nursing diagnoses, interventions and outcomes should be promoted.

[Analysis of the weaning process in intensive care patients with regard to documentation and transfer to further treatment units]. / Analyse des Weaningprozesses bei Intensivpatienten im Hinblick auf Dokumentation und Verlegung in weiterbehandelnde Einheiten.

BACKGROUND AND OBJECTIVES: Weaning from ventilators is not always finished in the primary intensive care unit (ICU) setting. Transfer to other treatment facilities is a sensitive stage in the treatment and rehabilitation of the weaning patient. The aim of the present study was to investigate transition management and interhospital transfer of weaning patients, with special emphasis on documentation quality. METHODS: A retrospective data analysis of one year (2018) in two ICUs of a university hospital was performed. All ventilated patients with the following tracer diagnoses were included: chronic obstructive pulmonary disease (COPD), asthma, patients with multiple injuries, pneumonia, sepsis, acute respiratory distress syndrome (ARDS), and cardiac arrest (ventilation > 24 h). RESULTS: A total of 750 patients were included in the study (median age 64 [IQR 52.8-76]; 32% female). In all, 48 (6.4%) patients were not weaned at the time of transfer (especially sepsis and ARDS). Routine documentation was sufficient for the sections "spontaneous breathing trial", "assessment of readiness to wean" and "presumed weanability" to adequately assess the parameters of the German S2k guideline "prolonged weaning". Predominantly, these patients were transferred with tracheostoma (76%) to rehabilitation units (44%) by specialized physician-assisted patient transport ambulances (75%). DISCUSSION: The transfer of ventilated patients after initial ICU stay is a relevant issue for interhospital transfer. Routine documentation of a structured weaning process is sufficient in core elements to describe the weaning process. This is of great importance for continuity in the further treatment of these patients.

Comparing the quality of care for long-term ventilated individuals at home versus in shared living communities: a convergent parallel mixed-methods study.

BACKGROUND: People on home mechanical ventilation (HMV) belong to a heterogeneous population with complex care needs. In Germany, outpatient intensive care is provided in people's private home (PH) or in shared living communities (SLC). Increasing patient numbers have led to criticism of the quality of care in recent years. Since quality deficits from the perspective of those affected are largely unclear, the following research question emerged: How do interviews with ventilated individuals and family caregivers explain any differences or similarities in the quality of care between PH and SLC? METHODS: This study used a mixed-methods convergent parallel design, where quantitative and qualitative components were separately collected and analysed. The quantitative component (structured interviews and online survey) included ventilation characteristics, health-related resource use, health-related quality of life (HRQL) measured with the Severe Respiratory Insufficiency Questionnaire (SRI; range 0-100; higher scores indicated higher HRQL) and the Burden Scale of the Family Caregivers short version (BSFC-s; range 0-30; higher scores indicated higher burden). The qualitative component (semi-structured interviews) focused on people's experience of person-centred care. Data were merged using a weaving method and the Picker framework of Person-Centred Care. RESULTS: The quantitative component revealed that ventilated individuals living in PHs were on average 20 years younger than participants living in SLCs (n = 46; PH: 46.86 ±15.40 years vs. SLC: 65.07 ±11.78 years; p = .001). HRQL (n = 27; PH: 56.62 ±16.40 vs. SLC: 55.35 ±12.72; p > .999) and the burden of family caregivers (n = 16; PH: 13.20 ±10.18 vs. SLC: 12.64 ±8.55; p > .999) were not significantly different between living situation. The qualitative component revealed that person-centred care is possible in both care settings (ventilated individuals: n = 13; family caregivers: n = 18). CONCLUSION: This study describes a care situation that is as heterogeneous as the population of people with HMV. HRQL and the burden of family caregivers are highly individual and, like person-centred care, independent of the living situation. Policy decisions that facilitate person-centred care need to recognise that quality of care is highly individual and starts with the free choice of the care setting.

Dual guidance structure for evaluation of patients with unclear diagnosis in centers for rare diseases (ZSE-DUO): study protocol for a controlled multi-center cohort study.

BACKGROUND: In individuals suffering from a rare disease the diagnostic process and the confirmation of a final diagnosis often extends over many years. Factors contributing to delayed diagnosis include health care professionals' limited knowledge of rare diseases and frequent (co-)occurrence of mental disorders that may complicate and delay the diagnostic process. The ZSE-DUO study aims to assess the benefits of a combination of a physician focusing on somatic aspects with a mental health expert working side by side as a tandem in the diagnostic process. STUDY DESIGN: This multi-center, prospective controlled study has a two-phase cohort design. METHODS: Two cohorts of 682 patients each are sequentially recruited from 11 university-based German Centers for Rare Diseases (CRD): the standard care cohort (control, somatic expertise only) and the innovative care cohort (experimental, combined somatic and mental health expertise). Individuals aged 12 years and older presenting with symptoms and signs which are not explained by current diagnoses will be included. Data will be collected prior to the first visit to the CRD's outpatient clinic (T0), at the first visit (T1) and 12 months thereafter (T2). OUTCOMES: Primary outcome is the percentage of patients with one or more confirmed diagnoses covering the symptomatic spectrum presented. Sample size is calculated to detect a 10 percent increase from 30% in standard care to 40% in the innovative dual expert cohort. Secondary outcomes are (a) time to diagnosis/diagnoses explaining the symptomatology; (b) proportion of patients successfully referred from CRD to standard care; (c) costs of diagnosis including incremental cost effectiveness ratios; (d) predictive value of screening instruments administered at T0 to identify patients with mental disorders; (e) patients' quality of life and evaluation of care; and f) physicians' satisfaction with the innovative care approach. CONCLUSIONS: This is the first multi-center study to investigate the effects of a mental health specialist working in tandem with a somatic expert physician in CRDs. If this innovative approach proves successful, it will be made available on a larger scale nationally and promoted internationally. In the best case, ZSE-DUO can significantly shorten the time to diagnosis for a suspected rare disease. Trial registration ClinicalTrials.gov; Identifier: NCT03563677; First posted: June 20, 2018, https://clinicaltrials.gov/ct2/show/NCT03563677 .

How to improve the quality of care for people on home mechanical ventilation from the perspective of healthcare professionals: a qualitative study.

BACKGROUND: The rapid increase in the use of home mechanical ventilation (HMV) for people with chronic respiratory failure poses extreme challenges for the healthcare system. People on HMV have complex care needs and require support from an interprofessional team. In Germany, HMV is criticised for inadequate quality standards, particularly in outpatient intensive care practice. The objective of this study was to describe the quality of care for people on outpatient HMV in Germany, Bavaria and provide recommendations for improvement from the perspective of healthcare professionals (HCPs). METHODS: Semi-structured qualitative telephone interviews with HCPs (i.e., nurses, equipment providers, therapists, and physicians) were analysed using the framework method. The quality framework of Health Improvement Scotland (HIS), which aims to improve the quality of person-centred care, was used to build a deductive analysis matrix. The framework includes the three key areas: (1) Outcomes and impact, (2) Service delivery, and (3) Vision and leadership. The domains (meta-codes) and quality indicators (sub-codes) of the quality framework were used for deductive coding. RESULTS: Overall, 87 HCPs (51 female, mean age of 44.3 years, mean professional experience in HMV of 9.4 years) were interviewed (mean duration of 31 min). There was a complex interaction between the existing health care system (Outcomes and impact, 955 meaning units), the delivery of outpatient intensive care (Service delivery, 939 meaning units), and improvement-focused leadership (Vision and leadership, 70 meaning units) that influenced the quality of care for people on HMV. The main barriers were an acceleration in transition management, a neglect of weaning potential, a shortage of qualified professionals and missing quality criteria. The central recommendations for promoting person-centred care were training and supervision of staff and an inspiring leadership. An integrated care structure supporting medical home visits and outpatient rehabilitation should be developed. CONCLUSION: This study describes a heterogeneous and partly deficient care situation for people on HMV, but demonstrates that high quality care is possible if person-centred care is successfully implemented in all areas of service provision. The recommendations of this study could inform the development of a person-centred integrated care structure for people on HMV.

Association Between Adherence to Quality Indicators and 7-Day In-Hospital Mortality After Acute Ischemic Stroke.

BACKGROUND AND PURPOSE: Quality indicators (QI) are an accepted tool to measure performance of hospitals in routine care. We investigated the association between quality of acute stroke care defined by overall adherence to evidence-based QI and early outcome in German acute care hospitals. METHODS: Patients with ischemic stroke admitted to one of the hospitals cooperating within the ADSR (German Stroke Register Study Group) were analyzed. The ADSR is a voluntary network of 9 regional stroke registers monitoring quality of acute stroke care across 736 hospitals in Germany. Quality of stroke care was defined by adherence to 11 evidence-based indicators of early processes of stroke care. The correlation between overall adherence to QI with outcome was investigated by assessing the association between 7-day in-hospital mortality with the proportion of QI fulfilled from the total number of QI the individual patient was eligible for. Generalized linear mixed model analysis was performed adjusted for the variables age, sex, National Institutes of Health Stroke Scale and living will and as random effect for the variable hospital. RESULTS: Between 2015 and 2016, 388 012 patients with ischemic stroke were reported (median age 76 years, 52.4% male). Adherence to distinct QI ranged between 41.0% (thrombolysis in eligible patients) and 95.2% (early physiotherapy). Seven-day in-hospital mortality was 3.4%. The overall proportion of QI fulfilled was median 90% (interquartile range, 75%-100%). In multivariable analysis, a linear association between overall adherence to QI and 7-day in-hospital-mortality was observed (odds ratio adherence <50% versus 100%, 12.7 [95% CI, 11.8-13.7]; P<0.001). CONCLUSIONS: Higher quality of care measured by adherence to a set of evidence-based process QI for the early phase of stroke treatment was associated with lower in-hospital mortality.

[Quality of Care for People with Home Mechanical Ventilation in Germany: A Scoping Review]. / Qualität der Versorgung beatmeter Menschen in der außerstationären Intensivpflege in Deutschland: Ein Scoping Review.

BACKGROUND: Outpatient intensive care for people with long-term mechanical ventilation is a rapidly growing area with a wide range of care demands. The aim of this Scoping Review is to present the current state of research on the quality of care for people with home mechanical ventilation in Germany and to identify research gaps. METHODS: Based on predefined inclusion criteria, 4 databases were searched for publications dealing with the care of people with home ventilation in Germany. The method of "data driven thematic analysis" led the data extraction and analysis. Distinction was made between research and expert opinion. RESULTS: The search resulted in 493 matches of which 68 publications were included in the this study: two guidelines (3%), 45 (66%) research papers and 21 (31%) expert opinions. The following topics were identified: Organization and control of ventilation (n=43; 63%), nursing (n=23; 34%), medical (n=39; 57%), therapeutic (n=7; 10%) and assistive technologies care (n=24; 35%), as well as the perspective of people with home mechanical ventilation and their relatives (n=33; 49%) and other topics (n=13; 19%). CONCLUSION: Although the debate on the quality of care for people living with home mechanical ventilation is conducted broadly, studies focusing on individual care demands, autonomy and participation depending on the living situation or on the role of specific health professionals within the interprofessional team are missing.

[Care of patients with Parkinson's disease in Germany]. / Versorgung von Parkinson-Patienten in Deutschland.

In Germany various concepts for treating patients with Parkinson's disease (PD) are available, e.g. oral medication with levodopa or deep brain stimulation (DBS), depending on the stage and severity of symptoms and also multidisciplinary management up to intersectoral treatment approaches (e.g. complex PD treatment and integrative care concepts). Nevertheless, in the treatment of patients with PD a comprehensive provision of services and a nationwide standardized collation of treatment quality are so far lacking. This is particularly true for technically complicated procedures, which necessitate a high standard of expertise by the treating physician. Some of these challenges could be overcome by expanding digital approaches (e.g. teleneurological consultation and wearables) and by introducing quality assurance initiatives (e.g. comprehensive registries and certification programs).

Development and proof-of-concept of a multicenter, patient-centered cancer registry for breast cancer patients with metastatic disease-the "Breast cancer care for patients with metastatic disease" (BRE-4-MED) registry.

BACKGROUND: Patients with metastatic breast cancer (MBC) are treated with a palliative approach with focus on controlling for disease symptoms and maintaining high quality of life. Information on individual needs of patients and their relatives as well as on treatment patterns in clinical routine care for this specific patient group are lacking or are not routinely documented in established Cancer Registries. Thus, we developed a registry concept specifically adapted for these incurable patients comprising primary and secondary data as well as mobile-health (m-health) data. METHODS: The concept for patient-centered "Breast cancer care for patients with metastatic disease" (BRE-4-MED) registry was developed and piloted exemplarily in the region of Main-Franconia, a mainly rural region in Germany comprising about 1.3 M inhabitants. The registry concept includes data on diagnosis, therapy, progression, patient-reported outcome measures (PROMs), and needs of family members from several sources of information including routine data from established Cancer Registries in different federal states, treating physicians in hospital as well as in outpatient settings, patients with metastatic breast cancer and their family members. Linkage with routine cancer registry data was performed to collect secondary data on diagnosis, therapy, and progression. Paper and online-based questionnaires were used to assess PROMs. A dedicated mobile application software (APP) was developed to monitor needs, progression, and therapy change of individual patients. Patient's acceptance and feasibility of data collection in clinical routine was assessed within a proof-of-concept study. RESULTS: The concept for the BRE-4-MED registry was developed and piloted between September 2017 and May 2018. In total n = 31 patients were included in the pilot study, n = 22 patients were followed up after 1 month. Record linkage with the Cancer Registries of Bavaria and Baden-Württemberg demonstrated to be feasible. The voluntary APP/online questionnaire was used by n = 7 participants. The feasibility of the registry concept in clinical routine was positively evaluated by the participating hospitals. CONCLUSION: The concept of the BRE-4-MED registry provides evidence that combinatorial evaluation of PROMs, needs of family members, and raising clinical parameters from primary and secondary data sources as well as m-health applications are feasible and accepted in an incurable cancer collective.

Rationale and design of the Registry of Acute Stroke Under Novel Oral Anticoagulants-prime (RASUNOA-prime).

BACKGROUND: Anticoagulation with vitamin K antagonists and non-vitamin K antagonists oral anticoagulants (NOAC) is effective in stroke prevention in patients with atrial fibrillation. However, anticoagulation also poses a major challenge for emergency treatment of patients suffering ischaemic stroke or intracerebral haemorrhage. AIM: The registry RASUNOA-prime is designed to describe current patterns of emergency management, clinical course and outcome of patients with atrial fibrillation experiencing an acute ischaemic stroke or intracerebral haemorrhage under different anticoagulation schemes prior to stroke (NOAC, vitamin K antagonists or no anticoagulation). METHODS AND DESIGN: RASUNOA-prime (ClinicalTrials.gov, NCT02533960) is a prospective, investigator-initiated, multicentre, observational cohort study aiming to recruit 3000 patients with acute ischaemic stroke and atrial fibrillation, and 1000 patients with acute intracerebral haemorrhage and atrial fibrillation with different anticoagulation schemes pre-stroke. It is a non-interventional triple-armed study aiming at a balanced inclusion of ischaemic stroke and intracerebral haemorrhage patients according to the different anticoagulation schemes. Patients will be followed up for clinical course, management and outcome up to three months after the event. Findings in ischaemic stroke and intracerebral haemorrhage patients on NOAC will be compared with patients taking vitamin K antagonists or no anticoagulant pre-stroke. STUDY OUTCOMES: Primary endpoint for ischaemic stroke patients: occurrence of symptomatic intracerebral haemorrhage, for intracerebral haemorrhage patients: occurrence of secondary haematoma expansion. Secondary endpoints include assessment of coagulation, use of thrombolysis and/or mechanical thrombectomy, occurrence of complications, implementation of secondary prevention. SUMMARY: Describing the current patterns of early management as well as outcome of stroke patients with atrial fibrillation will help guide physicians to develop recommendations for emergency treatment of stroke patients under different anticoagulation schemes.

Development of evidence-based quality indicators for deep brain stimulation in patients with Parkinson's disease and first year experience of implementation of a nation-wide registry.

INTRODUCTION: Deep Brain Stimulation (DBS) is a complex, invasive and cost-intensive therapy that requires a high level of expertise. To date, data on quality of DBS in clinical routine in the German health care system are lacking. METHODS: The development of evidence-based QIs for DBS in PD patients was performed following a standardized process by a multidisciplinary board between 2014 and 2016. The process was initiated by the German Parkinson Society and followed international recommendations for developing QIs including: a systematic literature search; an appraisal of the published evidence; a consensus-based selection of the QI set; and a pilot study to assess the feasibility in implementing the QIs in clinical routine. RESULTS: A set of 28 QIs for determining the quality of DBS in PD was established by the board covering different dimensions of health care quality (structure, process, and outcome) in different treatment phases of DBS care (pre-operative, peri-operative, and post-operative). Implementation in clinical practice was tested in a pilot study comprising three hospitals delivering DBS care. The feasibility of the QI set was evaluated positively by the participating physicians and hospitals. Mean time to document one patient was 25 min. The German-wide implementation of the defined indicator set within a dedicated quality registry (QualiPa) started in June 2016. CONCLUSION: QIs are a necessary requirement to monitor hospital performance in DBS care. The evidence-based approach to develop the proposed indicator set is expected to assure transparency, acceptance and long-term applicability of the QI set in Germany.

Coagulation Testing in Intracerebral Hemorrhage Related to Non-vitamin K Antagonist Oral Anticoagulants.

BACKGROUND: Intracerebral hemorrhage (ICH) is a life-threatening complication of non-vitamin K antagonist oral anticoagulants (NOAC). Little is known about the effect of intensity of anticoagulation on NOAC-ICH. We describe the current use of coagulation testing in the emergency setting and explore associations with baseline size and expansion of hematoma as determined in a previous study. METHODS: Data from the prospective multicenter RASUNOA registry were analyzed. Patients with NOAC-ICH were enrolled between February 2012 and December 2014. Frequency of local test performance of specific (anti-factor Xa tests, diluted thrombin time) and non-specific tests (international normalized ratio (INR), activated partial thromboplastin time (aPTT), thrombin time) was analyzed. The association of anticoagulation intensity at admission with hematoma volume and hematoma expansion was explored. RESULTS: In 61 NOAC-ICH patients enrolled at 21 centers, drug-specific coagulation testing was performed in 16 cases (26%), and only 29% of centers appeared to use drug-specific tests in NOAC-ICH at all. In some cases, INR and aPTT values were normal despite drug concentrations in the peak range. In patients with available drug-specific concentrations, 50% had drug levels in the peak range at admission. Higher intensity of anticoagulation was not associated with higher hematoma volume at admission or with subsequent hematoma expansion. CONCLUSION: Drug-specific tests are only infrequently used in NOAC-ICH. Normal results in non-specific coagulation do not reliably rule out peak range concentrations. Anticoagulation intensity at admission does not predict baseline hematoma volume or subsequent hematoma expansion.

Haemorrhagic Transformation after Ischaemic Stroke in Patients Taking Non-vitamin K Antagonist Oral Anticoagulants.

BACKGROUND AND PURPOSE: To evaluate the frequency and outcome of haemorrhagic transformation (HT) after ischaemic stroke in patients treated with non-vitamin K antagonist oral anticoagulants (NOACs). METHODS: Patients with stroke on treatment with a NOAC were prospectively enrolled in this multicentre observational study between February 2012 and 2015. Brain imaging at admission and follow-up imaging until day 7 were reviewed for HT. Functional outcome was assessed by the modified Rankin scale (mRS) before the index event, at discharge, and at 3-months. RESULTS: 231 patients without recanalisation therapy (no-RT), and 32 patients with RT were eligible for analysis. Any HT was present at admission in 9/231 no-RT patients (3.9%, 95% CI 2.0 to 7.3) and in none of the patients with RT. In patients with follow-up imaging (no-RT, n=129, and RT, n=32), HT was present in 14.0% (no-RT; 95% CI, 8.9 to 21.1), and 40.6% (RT, 95% CI, 25.5 to 57.8), respectively. After adjustment for stroke severity, this difference between the no-RT and RT groups became non-significant. Symptomatic ICH was observed in 1 patient per group. HT was not associated with unfavourable outcome (mRS 3-6) at 3-months in multivariable analysis. Resumption of OAC after stroke was delayed in patients with HT compared to those without (15 d [IQR, 5-26] vs. 1 d [0-4], P<0.001). CONCLUSIONS: The frequency and severity of HT after stroke on NOAC appears similar to previous reports for vitamin K antagonists and no anticoagulation. Whether asymptomatic HT should delay resumption of preventive anticoagulation requires further investigation.