[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.

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.

Comorbid diseases among bullous pemphigoid patients in Germany: new insights from a case-control study.

BACKGROUND AND OBJECTIVES: Bullous pemphigoid (BP) is associated with neuropsychiatric disorders. Other comorbid diseases are discussed controversially. We evaluated the prevalence of comorbidity in BP patients in a representative area of Germany. PATIENTS AND METHODS: Medical files of all BP patients treated at the Department of Dermatology, University Hospital Würzburg, Germany, between June 2002 and May 2013 were retrospectively reviewed. Bullous pemphigoid was diagnosed based on established criteria. For each patient, two controls were individually matched. Records were evaluated for age, sex, laboratory values, concomitant medication and comorbidity. Conditional logistic regression, multivariable regression analysis and complex regression models were performed to compare results. RESULTS: 300 BP patients were identified and compared to 583 controls. Bullous pemphigoid was associated with neuropsychiatric disorders as well as laboratory abnormalities including leukocytosis and eosinophilia. Importantly, a highly significant association of BP with anemia (OR 2.127; 95 % CI 1.532-2.953) and renal impairment (OR 2.218; 95 % CI 1.643-2.993) was identified. No association was found with malignancy and arterial hypertension. CONCLUSIONS: Our data revealed an increased frequency of anemia and renal impairment in BP patients. In accordance with previous studies the strong association for neuropsychiatric disorders was confirmed (p < 0.0005).

Rationale and design of the cardiovascular status in patients with endogenous cortisol excess study (CV-CORT-EX): a prospective non-interventional follow-up study.

BACKGROUND: Endogenous Cushing's syndrome (CS) results in increased cardiovascular (CV) morbidity and mortality. So far, most studies focussed on distinct disease entities rather than the integrity of the CV system. We here describe the design of the Cardiovascular Status in Endogenous Cortisol Excess Study (CV-CORT-EX), a study aiming to comprehensively investigate the health status of patients with endogenous CS (with a particular focus on CV phenotypes, biochemical aspects, quality of life, and psychosocial status). METHOD: A prospective non-interventional cohort study performed at a German tertiary referral centre. At the time of enrolment, patients will be categorised as: (1) newly diagnosed overt CS, (2) recurrent overt CS, (3) CS in remission, (4) presence of mild autonomous cortisol excess (MACE). The target cohorts will be n = 40 (groups 1 + 2), n = 80 (group 3), and n = 20 (group 4). Patients with overt CS at the time of enrolment will be followed for 12 months after remission (with re-evaluations after 6 and 12 months). At each visit, patients will undergo transthoracic echocardiography, cardiac magnetic resonance imaging, 24-h electrocardiogram, 24-h blood pressure measurement, and indirect evaluation of endothelial function. Furthermore, a standardised clinical investigation, an extensive biochemical workup, and a detailed assessment of quality of life and psychosocial status will be applied. Study results (e.g. cardiac morphology and function according to transthoracic echocardiography and cardiac magnetic resonance imaging; e.g. prevalence of CV risk factors) from patients with CS will be compared with matched controls without CS derived from two German population-based studies. DISCUSSION: CV-CORT-EX is designed to provide a comprehensive overview of the health status of patients with endogenous CS, mainly focussing on CV aspects, and the holistic changes following remission. TRAIL REGISTRATION: ClinicalTrials.gov ( https://clinicaltrials.gov/ ) NCT03880513, registration date: 19 March 2019 (retrospectively registered). Protocol Date: 28 March 2014, Version 2.

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.

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

BACKGROUND: Factors 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. METHODS: Data 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. RESULTS: In 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 (p < .0001), an interval onset to admission time ≤3 h (p < .0001), and weekend admission (p < .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 (p = 0.0002). Quality of stroke care could be maintained even if certification was several years ago. CONCLUSIONS: Differences 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.

Regulation of blood coagulation factors XI and XII in patients with acute and chronic cerebrovascular disease: a case-control study.

BACKGROUND: Animal models have implicated an integral role for coagulation factors XI (FXI) and XII (FXII) in thrombus formation and propagation of ischemic stroke (IS). However, it is unknown if these molecules contribute to IS pathophysiology in humans, and might be of use as biomarkers for IS risk and severity. This study aimed to identify predictors of altered FXI and FXII levels and to determine whether there are differences in the levels of these coagulation factors between acute cerebrovascular events and chronic cerebrovascular disease (CCD). METHODS: In this case-control study, 116 patients with acute ischemic stroke (AIS) or transitory ischemic attack (TIA), 117 patients with CCD, and 104 healthy volunteers (HVs) were enrolled between 2010 and 2013 at our University hospital. Blood sampling was undertaken once in the CCD and HV groups and on days 0, 1, and 3 after stroke onset in patients with AIS or TIA. Correlations between serum FXI and FXII levels and demographic and clinical parameters were tested by linear regression and analysis of variance. RESULTS: The mean age of AIS/TIA patients was 70 ± 12. Baseline clinical severity measured with NIHSS and Barthel Index was 4.8 ± 6.0 and 74 ± 30, respectively. More than half of the patients had an AIS (58%). FXI levels were significantly correlated with different leukocyte subsets (p < 0.05). In contrast, FXII serum levels showed no significant correlation (p > 0.1). Neither FXI nor FXII levels correlated with CRP (p > 0.2). FXII levels were significantly higher in patients with CCD compared with those with AIS/TIA (mean ± SD 106 ± 26% vs. 97 ± 24%; univariate analysis: p < 0.05); these differences did not reach significance in multivariate analysis adjusted for sex and age. FXI levels did not differ significantly between study groups. Sex and age were significantly associated with FXI and/or FXII levels in patients with AIS/TIA (p < 0.05). In contrast, no statistical significant influence was found for treatment modality (thrombolysis or not), pre-treatment with platelet inhibitors, and severity of stroke. CONCLUSIONS: In this study, there was no differential regulation of FXI and FXII levels between disease subtypes but biomarker levels were associated with patient and clinical characteristics. FXI and FXII levels might be no valid biomarker for predicting stroke risk.

The influence of neighborhood unemployment on mortality after stroke.

BACKGROUND: Few studies have investigated the impact of neighborhood characteristics on mortality after stroke. Aim of our study was to analyze the influence of district unemployment as indicator of neighborhood socioeconomic status (SES-NH) on poststroke mortality, and to compare these results with the mortality in the underlying general population. METHODS: Our analyses involve 2 prospective cohort studies from the city of Dortmund, Germany. In the Dortmund Stroke Register (DOST), consecutive stroke patients (N=1883) were recruited from acute care hospitals. In the Dortmund Health Study (DHS), a random general population sample was drawn (n=2291; response rate 66.9%). Vital status was ascertained in the city's registration office and information on district unemployment was obtained from the city's statistical office. We performed multilevel survival analyses to examine the association between district unemployment and mortality. RESULTS: The association between neighborhood unemployment and mortality was weak and not statistically significant in the stroke cohort. Only stroke patients exposed to the highest district unemployment (fourth quartile) had slightly higher mortality risks. In the general population sample, higher district unemployment was significantly associated with higher mortality following a social gradient. After adjustment for education, health-related behavior and morbidity was made the strength of this association decreased. CONCLUSIONS: The impact of SES-NH on mortality was different for stroke patients and the general population. Differences in the association between SES-NH and mortality may be partly explained by disease-related characteristics of the stroke cohort such as homogeneous lifestyles, similar morbidity profiles, medical factors, and old age.

Differences in Preferences for Drug Therapy Between Patients with Metastatic Versus Early-Stage Breast Cancer: A Systematic Literature Review.

INTRODUCTION: Compared with early stages (eBC) metastatic BC (mBC) is incurable. In mBC, aggressive treatment may increase the duration of survival but may also cause severe treatment side effects. A better understanding how patients with BC value different aspects of drug therapy might improve treatment effectiveness, satisfaction and adherence. This systematic review aims to identify and summarise studies evaluating patient preferences for drug therapy of BC and to compare preferences of patients with eBC and mBC. METHODS: The systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The electronic databases PubMed and Web of Science were searched on 22 June 2023. All studies published to this point were considered. Original studies reporting patient preferences on BC drug therapy determined by any type of choice experiment were eligible. A narrative synthesis of the effect measures presented as relative importance ratings, trade-offs (required benefit to make a therapy worthwhile) or monetary values of the treatment attributes was reported for each study. Risk of bias assessment for individual studies was performed using the checklist for observational studies from the STROBE Statement and the checklist from 'Conducting Discrete Choice Experiments to Inform Healthcare Decision Making: A User's Guide'. The study protocol was registered at the PROSPERO database (CRD42022377031). RESULTS: A total of 34 studies met the inclusion criteria were included in the analysis evaluating the preferences of patients with eBC (n = 18), mBC (n = 10) or any stage BC (n = 6) on, for example, chemotherapy, endocrine therapy, hormonal therapy or CKD4/6-inhibitors using different types of choice experiments. Regardless of the stage, most patients valued treatment effectiveness in terms of survival gains higher than potential adverse drug reactions (ADRs). Treatment cost, mode of administration, treatment regimen and monitoring aspects were considered as least important treatment attributes. In addition, preferences concerning 16 different types of ADRs were described, showing high heterogeneity within BC stages. Yet, comparable results across BC stages were observed. CONCLUSIONS: Regardless of the stage, patients with BC consistently valued survival gains as the most important attribute and were willing to accept the risk of potential ADRs. Incorporating patient preferences in shared decision making may improve the effectiveness of interventions by enhancing adherence to drug therapy in patients suffering from BC.

Preferences of patients with breast cancer for drug therapy play a crucial role in treatment efficacy, satisfaction and adherence. In this systematic review following the PRISMA guidelines, 34 studies were analysed to determine patient preferences at different stages of breast cancer, comparing early stage and metastatic disease. Regardless of stage, patients with breast cancer consistently prioritised survival benefit as the most important treatment feature. This universal emphasis on survival held true even in the face of potential side effects, with patients willing to accept the associated risks. Conversely, factors unrelated to efficacy, such as the cost of treatment, route of administration, characteristics of the treatment regimen and monitoring aspects, were considered less important in treatment decisions. The study revealed a nuanced landscape of patient preferences, with greater variation within breast cancer stages than between them. While survival remained an unwavering priority, the variability in expressed preferences emphasises the individual nature of patient perspectives. In conclusion, incorporating patient preferences, particularly those that emphasise the importance of survival, into shared decision-making processes is a critical factor in improving treatment adherence. This patient-centred approach is likely to improve the overall effectiveness of breast cancer treatment and highlights the need for tailored strategies that take into account the individual preferences of patients at different stages of the disease.

The structured ambulatory post-stroke care program for outpatient aftercare in patients with ischaemic stroke in Germany (SANO): an open-label, cluster-randomised controlled trial.

BACKGROUND: Patients with ischaemic stroke are at risk of recurrent stroke. In this study, we aimed to compare the effect of a structured ambulatory post-stroke care programme versus usual care on recurrent vascular events and death and control of cardiovascular risk factors. METHODS: We did a prospective, open-label, cluster-randomised controlled trial (SANO) at stroke centres in regions of Germany. A cluster was defined as a region in which acute stroke care is provided by a participating stroke centre. Patients were eligible for participation if they were aged 18 years or older, had no severe disabilities before the index stroke (modified Rankin scale 0-1), had at least one modifiable cardiovascular risk factor, and presented within 14 days of symptom onset of their first ischaemic stroke. The participating regions were randomly assigned (1:1) to the intervention and control group (usual care) by the statistician using block randomisation (block sizes of six), stratified by rural and urban regions. In intervention regions, a cross-sectoral multidisciplinary network was established to provide a 1-year organisational and patient-centred intervention. Due to the type of intervention, masking of participants and study physicians was not possible. Endpoint adjudication was performed by an independent endpoint adjudication committee who were masked to cluster allocation. The primary endpoint was a composite of recurrent stroke, myocardial infarction, and all-cause death within 12 months after baseline assessment, assessed in the modified intention-to-treat (mITT) population, which included all patients who did not withdraw consent and completed the primary endpoint assessment at 12 months. This study was registered with the German Clinical Trials Register, DRKS00015322. FINDINGS: Between Jan 1, 2019 and Dec 22, 2020, 36 clusters were assessed for eligibility, of which 30 were randomly assigned to the intervention group (n=15 clusters) or control group (n=15 clusters). No clusters dropped out of the study. 1203 (86%) of 1396 enrolled patients in the intervention group and 1283 (92%) of 1395 enrolled patients in the control group were included in the mITT population. The primary endpoint was confirmed in 64 (5·3%) of 1203 patients in the intervention group and 80 (6·2%) of 1283 patients in the control group (unadjusted odds ratio [OR] 0·80 [95% CI 0·49-1·30]; adjusted OR [aOR] 0·95 [95% CI 0·54-1·67]). All-cause deaths occurred in 31 (2·4%) of 1203 patients in the intervention group and 12 (1·0%) of 1283 patients in the control group. The incidence of serious adverse events was higher in the intervention group (266 [23·1%] of 1151) than the control group (106 [9·2%] of 1152). Falls (134 [11·4%] of 1203 patients in the intervention group; 39 [3·3%] of 1152 patients in the control group), hypertensive crisis (55 [4·7%]; 34 [2·8%]), and diagnosis of depression (51 [4·3%]; 13 [1·1%]) were the most frequent adverse events in both groups. No differences were identified in the rate of readmission to hospital between groups. INTERPRETATION: No differences were identified between patients with ischaemic stroke in the intervention group and control group with regard to the incidence of vascular events 1 year after baseline assessment, despite positive effects with regard to the control of some cardiovascular risk factors. Longer-term effects and other potentially favourable effects on stroke-related sequelae and quality of life require further evaluation. FUNDING: Innovation Fund of the Federal Joint Committee.

Development of a clinical score (A2DS2) to predict pneumonia in acute ischemic stroke.

BACKGROUND AND PURPOSE: Poststroke pneumonia is a potentially preventable complication after stroke associated with poor outcome. We developed and externally validated a prognostic score for predicting risk of pneumonia after ischemic stroke. METHODS: The prognostic score was developed based on clinical data routinely collected after admission from the Berlin Stroke Register, Germany. The association of demographics, comorbidities, and clinical characteristics with poststroke pneumonia was investigated using multivariable logistic regression analyses. Independent predictors of poststroke pneumonia were translated into a point scoring system based on the corresponding regression coefficients. The predictive properties of the developed prognostic score were externally validated using an independent data set from the Stroke Register Northwest-Germany. RESULTS: Between 2007 and 2009, 15 335 patients with ischemic stroke were registered within the Berlin Stroke Register. The observed rate of pneumonia in hospital was 7.2%. A 10-point score was derived for prediction of poststroke pneumonia (Age ≥ 75 years=1, Atrial fibrillation=1, Dysphagia=2, male Sex=1, stroke Severity, National Institutes of Health Stroke Scale 0-4=0, 5-15=3, ≥ 16=5; A(2)DS(2)). The proportion of pneumonia varied between 0.3% in patients with a score of 0 point to 39.4% in patients with a score of 10 points. The score demonstrated excellent discrimination (C-statistic 0.84; 95% CI, 0.83-0.85) and calibration (McFadden R(2)=0.21). Prediction, discrimination, and calibration properties were reproduced in the validation cohort consisting of 45 085 patients with ischemic stroke. CONCLUSIONS: The A(2)DS(2) score is a valid tool for predicting poststroke pneumonia based on routinely available data. A(2)DS(2) might be useful for guiding monitoring of high-risk patients or prophylactic pneumonia management in clinical routine.

Association between socioeconomic status and functional impairment 3 months after ischemic stroke: the Berlin Stroke Register.

BACKGROUND AND PURPOSE: We aimed to analyze the association between patient socioeconomic status and functional impairment 3 months after ischemic stroke and to identify factors that influence this association. METHODS: Data were obtained from the Berlin Stroke Register, a network of 14 stroke units in Berlin. Ischemic stroke patients consecutively admitted to 1 of the hospitals in the Berlin Stroke Register between June 2010 and September 2011, were followed-up 3 months after the index event by postal or telephone interview. We used multivariable logistic regression to examine the association between highest education as marker of socioeconomic status and functional impairment after stroke defined by Barthel Index categories. We adjusted for age, sex, prestroke dependency, stroke severity, functional deficit after stroke onset, and comorbidities as possible confounding factors. RESULTS: A total of 1688 ischemic stroke patients who were alive at 3 months and completed the questionnaire were included in the analysis; 40% of the patients were female and 50% of the patients were 70 years or older. Age, prestroke dependency, stroke severity, and the absence of comorbidities were significantly associated with good functional outcome at 3 months. In multivariable analysis, a higher probability of good outcome was observed in patients with college or university degree (odds ratio, 2.18; 95% confidence interval, 1.39-3.42) compared with patients with no completed education. CONCLUSIONS: Patients with lower education have considerably lower rates of good functional outcome after stroke that cannot be fully explained by variations in the patients' clinical and demographic characteristics.

Endothelial and Leukocyte-Derived Microvesicles and Cardiovascular Risk After Stroke: PROSCIS-B.

OBJECTIVE: To determine the role of circulating microvesicles (MV) on long-term cardiovascular outcomes after stroke, we measured them in patients with first-ever stroke with a 3-year follow-up. METHODS: In the Prospective Cohort With Incident Stroke Berlin (PROSCIS-B), patients with first-ever ischemic stroke were followed up for 3 years. The primary combined endpoint consisted of recurrent stroke, myocardial infarction, and all-cause mortality. Citrate-blood levels of endothelial MV (EMV), leukocyte-derived MV (LMV), monocytic MV (MMV), and platelet-derived MV (PMV) were measured with flow cytometry. Kaplan-Meier curves and adjusted Cox proportional hazards models were used to estimate the effect of MV levels on the combined endpoint. RESULTS: Five hundred seventy-one patients were recruited (median age 69 years, 39% female, median NIH Stroke Scale score 2, interquartile range 1-4), and 95 endpoints occurred. Patients with levels of EMV (adjusted hazard ratio [HR] 2.5, 95% confidence interval [CI] 1.2-4.9) or LMV (HR 3.1, 95% CI 1.4-6.8) in the highest quartile were more likely to experience an event than participants with lower levels with the lowest quartile used as the reference category. The association was less pronounced for PMV (HR 1.7, 95% CI 0.9-3.2) and absent for MMV (HR 1.1, 95% CI 0.6-1.8). CONCLUSION: High levels of EMV and LMV after stroke were associated with worse cardiovascular outcome within 3 years. These results reinforce that endothelial dysfunction and vascular inflammation affect the long-term prognosis after stroke. EMV and LMV might play a role in risk prediction for stroke patients. CLINICALTRIALSGOV IDENTIFIER: NCT01363856. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence of the effect of MV levels on subsequent stroke, myocardial infarction, or all-cause mortality in survivors of mild stroke.

Trial design and pilot phase results of a cluster-randomised intervention trial to improve stroke care after hospital discharge - The structured ambulatory post-stroke care program (SANO).

INTRODUCTION: Previous studies showed insufficient control of cardiovascular risk factors (CVRF) and high stroke recurrence rates among ischemic stroke patients in Germany. Currently, no structured secondary prevention program exists in clinical routine. We present the trial design and pilot phase results of a complex intervention to improve stroke care after hospital discharge in Germany. PATIENTS AND METHODS: SANO is a cluster-randomized trial with 30 participating regions across Germany aiming to enrol 2,790 patients (drks.de, DRKS00015322). Study intervention combines both structural and patient-centred elements. Study development was based on the Medical Research Council framework for complex interventions. In 15 intervention regions, a cross-sectoral multidisciplinary network is established to enhance CVRF control as well as detection and treatment of post-stroke complications. Recommendations on CVRF are based on high-quality secondary prevention guidelines. Study physicians use motivational interviewing and agree with patients on therapeutic targets. While hospitalised, patients also receive dietary counselling and a health-passport to track their progress. During regular visits, CVRF management and potential complications are monitored. The intervention is compared to 15 regions providing usual care. The primary endpoint is the combination of recurrent stroke, myocardial infarction and death assessed 12 months after enrolment and adjudicated in a blinded manner. RESULTS: Eighteen patients were enrolled in a pilot phase that demonstrated feasibility of patient recruitment and study procedures. CONCLUSION: SANO is investigating a program to reduce outcome events after ischemic stroke by implementing a complex intervention. If successful, the program may be implemented in routine care on national level in Germany.

Cluster randomized controlled trial of a patient and general practitioner intervention to improve the management of multiple risk factors after stroke: stop stroke.

BACKGROUND AND PURPOSE: Stroke is a major public health concern worldwide and survivors remain at high risk of recurrence. Secondary prevention requires management of multiple risk factors but current management is suboptimal. Evidence of the effectiveness of interventions to improve poststroke risk factor management from well-designed trials is limited. We assessed the effectiveness of a patient and general practitioner systematic follow-up intervention to improve risk factor management after stroke. METHODS: We undertook a pragmatic cluster trial involving 523 consecutive incident stroke survivors identified using the population South London Stroke Register and registered with general practices in inner-city London. Practices were randomized to receive the intervention or usual care. The intervention entailed systematically identifying stroke survivors' risk factors for recurrence and providing tailored evidence-based management advice to general practitioners, patients, and caregivers at 10 weeks, 5 months, and 8 months poststroke. The primary outcome was management of key modifiable risk factors for stroke at 1 year with 3 end points: treatment with antihypertensive therapy, treatment with antiplatelet therapy, and smoking cessation. Hierarchical testing was used to adjust for multiple endpoints. Analysis was by intention to treat. This study is registered as number ISRCTN10730637. RESULTS: The absolute risk reduction (and 95% CI) for each outcome was -3.7% (-13.0% to 5.6%) for treatment with antihypertensives; -2.3% (-12.0% to 7.6%) for treatment with antiplatelets; and -0.6% (-14.5% to 13.5%) for smoking cessation. Treatment effects were confirmed in the generalized linear model adjusting for clustering and predefined confounders. CONCLUSIONS: No improvement in risk factor management was demonstrated as a result of this patient, caregiver, and healthcare professional systematic follow-up system. Further evidence of how to effectively alter behavior of patients/caregivers and professionals is required if tailored information on risk and its treatment is to be of any clinical benefit.

The impact of lesion location and lesion size on poststroke infection frequency.

OBJECTIVES: Infections in patients with stroke are common and significantly affect outcome. Various predictors of poststroke infections were determined, such as degree of neurological impairment and implementation of therapeutic interventions. The authors investigated whether stroke location and stroke size are independent risk factors for poststroke infections. METHODS: 591 patients with acute stroke who were treated on our stroke unit were included in a prospective observational study. Predefined endpoints were pneumonia, urinary-tract infection (UTI) and other infections. The OR of infections was calculated for various stroke locations, stroke lateralisation and three categories of stroke size. Logistic regression models were used to adjust for factors significantly associated with poststroke infections in a single-factor analysis. RESULTS: In the single-factor analysis, the left anterior cerebral artery territory was associated with pneumonia. After adjustment for relevant covariates, this association was no longer statistically significant. Stroke lateralisation showed no association with infection frequency. The largest stroke size was positively associated with pneumonia (OR 3.5, p<0.001). The smallest lesion size was significantly less associated with the occurrence of UTI (OR 0.4, p<0.01). CONCLUSION: In this study, lesion size is an independent risk factor for the development of poststroke infection. Particular brain regions associated with infections could not be determined.

Antihypertensive treatment after stroke and all-cause mortality--an analysis of the General Practitioner Research Database (GPRD).

BACKGROUND: Randomised controlled trials have shown a beneficial effect of antihypertensive treatment on stroke recurrence. The effect of antihypertensive treatment on survival and recurrence in an unselected sample of the general population, using the General Practice Research Database, was analysed. METHODS: Cox regression estimating the effect of antihypertensive treatment on survival and stroke recurrence >1 year among 44,244 first-ever strokes in the UK from 1997 to 2006 was adjusted by propensity score analysis considering gender, age, general practice, stroke year, drug prescriptions and diagnostic codes from other diseases. RESULTS: The EU standardised stroke incidence was 118 per 100,000 (95% CI = 117-120). The 90-day case fatality was 19%. By 90 days after stroke 20,147 (58%) were diagnosed as having hypertension, of whom 75% had received antihypertensive treatment after stroke. After 5 years 68% of the hypertensive stroke patients receiving antihypertensive treatment were alive, while this proportion for patients not prescribed antihypertensive treatment was 59%. This could not be explained by potential confounders with an adjusted relative risk of 0.62 (95% CI = 0.58-0.66; p < 0.001) for antihypertensive treatment and premature death. The adjusted relative risk of antihypertensive treatment on stroke recurrence after 1 year, which was observed in 35% until 5 years after stroke, was 0.92 (95% CI = 0.84-1.01; p = 0.092). CONCLUSIONS: A high proportion of hypertensive stroke patients did not receive antihypertensive treatment. The protective effect of antihypertensive treatment on survival was higher in this general population than reported in randomised controlled trials, while an effect of antihypertensive treatment on late stroke recurrence was borderline, but not significant.

Case-control study of platelet glycoprotein receptor Ib and IIb/IIIa expression in patients with acute and chronic cerebrovascular disease.

BACKGROUND: Animal models have been instrumental in defining thrombus formation, including the role of platelet surface glycoprotein (GP) receptors, in acute ischemic stroke (AIS). However, the involvement of GP receptors in human ischemic stroke pathophysiology and their utility as biomarkers for ischemic stroke risk and severity requires elucidation. AIMS: To determine whether platelet GPIb and GPIIb/IIIa receptors are differentially expressed in patients with AIS and chronic cerebrovascular disease (CCD) compared with healthy volunteers (HV) and to identify predictors of GPIb and GPIIb/IIIa expression. METHODS: This was a case-control study of 116 patients with AIS or transient ischemic attack (TIA), 117 patients with CCD, and 104 HV who were enrolled at our University hospital from 2010 to 2013. Blood sampling was performed once in the CCD and HV groups, and at several time points in patients with AIS or TIA. Linear regression and analysis of variance were used to analyze correlations between platelet GPIb and GPIIb/IIIa receptor numbers and demographic and clinical parameters. RESULTS: GPIb and GPIIb/IIIa receptor numbers did not significantly differ between the AIS, CCD, and HV groups. GPIb receptor expression level correlated significantly with the magnitude of GPIIb/IIIa receptor expression and the neutrophil count. In contrast, GPIIb/IIIa receptor numbers were not associated with peripheral immune-cell sub-population counts. C-reactive protein was an independent predictor of GPIIb/IIIa (not GPIb) receptor numbers. CONCLUSIONS: Platelet GPIb and GPIIb/IIIa receptor numbers did not distinguish between patient or control groups in this study, negating their potential use as a biomarker for predicting stroke risk.

Von Willebrand factor regulation in patients with acute and chronic cerebrovascular disease: a pilot, case-control study.

BACKGROUND AND PURPOSE: In animal models, von Willebrand factor (VWF) is involved in thrombus formation and propagation of ischemic stroke. However, the pathophysiological relevance of this molecule in humans, and its potential use as a biomarker for the risk and severity of ischemic stroke remains unclear. This study had two aims: to identify predictors of altered VWF levels and to examine whether VWF levels differ between acute cerebrovascular events and chronic cerebrovascular disease (CCD). METHODS: A case-control study was undertaken between 2010 and 2013 at our University clinic. In total, 116 patients with acute ischemic stroke (AIS) or transitory ischemic attack (TIA), 117 patients with CCD, and 104 healthy volunteers (HV) were included. Blood was taken at days 0, 1, and 3 in patients with AIS or TIA, and once in CCD patients and HV. VWF serum levels were measured and correlated with demographic and clinical parameters by multivariate linear regression and ANOVA. RESULTS: Patients with CCD (158 ± 46%) had significantly higher VWF levels than HV (113 ± 36%, P<0.001), but lower levels than AIS/TIA patients (200 ± 95%, P<0.001). Age, sex, and stroke severity influenced VWF levels (P<0.05). CONCLUSIONS: VWF levels differed across disease subtypes and patient characteristics. Our study confirms increased VWF levels as a risk factor for cerebrovascular disease and, moreover, suggests that it may represent a potential biomarker for stroke severity, warranting further investigation.