Correction: Blindow et al. Re-Establishment Techniques and Transplantations of Charophytes to Support Threatened Species. Plants 2021, 10, 1830.

In the original publication [...].

Experiences of Next-of-Kin to Foreign-Born Dying Patients Cared for in Specialist Palliative Care: A Qualitative Study.

Earlier studies have shown that healthcare personnel in specialized palliative care see patients with migrant backgrounds as others and that they, as providers, are unable to provide culturally competent care. Thus, these studies indicate a taken for granted perception, instead of knowledge based on experiences or scientific knowledge. The objectives of this study were to explore preferences, expectations on and experiences of specialist palliative care from next-of-kin of migrants of different origin. This study used a qualitative methodology, and the data were analyzed with systematic text condensation. The interviews were based on semi-structured interviews with seven next-of-kin. Four code groups represented the next-of kin's experiences: The wishes and needs of the foreign-born person in a palliative phase form the care; The families' prerequisites for, and the impact of, palliative informal caregiving; The staff working in accordance with a palliative care approach; Palliative care in a seamless care chain.

Understanding the challenges and need for support of informal caregivers to individuals with head and neck cancer - A basis for developing internet-based support.

PURPOSE: Being an informal caregiver of an individual with head and neck cancer can be demanding. Still, informal caregivers can provide valuable support to patients throughout the disease trajectory. The aim of this study was to explore informal caregivers' views on their challenges and needs in attaining high preparedness for caregiving. METHODS: Fifteen informal caregivers of individuals with head- and neck cancer participated in a focus group discussion or an individual interview. Thematic analysis utilizing an inductive approach was performed. RESULTS: The results describe the challenges that informal caregivers to individuals with head and neck cancer perceive and their needs for support in preparedness for caregiving. Three main themes were found: Challenges of being an informal caregiver, Transformation in life and Informal caregiver' needs of support and sharing care. CONCLUSION: This study contributes to the understanding of the challenges for informal caregivers to individuals with head and neck cancer in increasing preparedness for caregiving. To improve preparedness for caregiving, informal caregivers need education, information and support regarding physical, psychological and social issues for individuals with head and neck cancer.

Long-term effects on depression and anxiety of an internet-based stepped care intervention for patients with cancer and symptoms of depression and anxiety. The U-CARE AdultCan trial.

Background: Cancer is a serious disease that commonly causes significant psychological distress. The internet-based intervention (iCAN-DO), utilizing a stepped care approach for the treatment of anxiety and depression in individuals with cancer, has been shown to have favorable results for symptoms of depression at the primary endpoint, 10 months after randomization compared to standard care (SC). The aim of the present study was to evaluate the long-term effects of the intervention 18 and 24 months after randomization. Methods: Patients with breast, colorectal, or prostate cancer and a score > 7 on either of the Hospital Anxiety and Depression Scale (HADS) subscales (n = 245) were recruited to the study in conjunction with a regular hospital visit. They were randomized to access to the stepwise iCAN-DO intervention for 24 months or to SC. Step 1 of the intervention comprised psycho-educative online material. In Step 2, internet-based cognitive-behavioral therapy with individual online support from a therapist was added. Step 2 was offered to those who reported persistent anxiety or depression symptoms (>7 on HADS), also at 1, 4, and/or 7 months after randomization. Missing data were imputed using the last rank carried forward method and used for the main analyses according to the intention-to-treat approach. Effects sizes (Cohen's d), and minimally clinically important difference (MCID) were calculated. Linear mixed models were used to analyze intervention effects over time. Results: Symptoms of depression decreased significantly (p < 0.05) in the iCAN-DO group compared with the SC group from baseline to 18 months (d = 0.29), but not to 24 months (d = 0.27). Even though the average iCAN-DO group participant surpassed a MCID in symptoms of anxiety (>2 p) at both long-term follow-ups, the differences did not reach statistical significance, either at 18 months (p = 0.10) or 24 months (p = 0.09). Positive effects of iCAN-DO compared with the SC were also shown for some secondary HRQoL-outcomes; social functioning at 18 months (p = 0.02) and 24 months (p = 0.001), and sleep problems at 24 months (p = 0.01). Conclusion: A stepped-care internet-based intervention that has previously shown positive results for symptoms of depression at 10 months did show similar positive long-term effects also at 18 months. For symptoms of anxiety, no effect could be shown. The internet may provide an effective format for interventions to reduce symptoms of depression after cancer at patients' own choice of time, regardless of distance to a psycho-oncology clinic.

Positive Design Framework for Carer eSupport: Qualitative Study to Support Informal Caregivers of Patients With Head and Neck Cancer in Sweden.

BACKGROUND: Informal caregivers of patients with head and neck cancer (HNC), such as the patient's spouse, other close relatives, or friends, can play an important role in home-based treatment and health care. Research shows that informal caregivers are usually unprepared for this responsibility and need support with taking care of patients and other daily life activities. These circumstances place them in a vulnerable position, and their well-being may be compromised. This study is part of our ongoing project Carer eSupport, which aims to develop a web-based intervention to facilitate informal caregivers in the home environment. OBJECTIVE: This study aimed to explore the situation and context of informal caregivers of patients with HNC and their needs for designing and developing a web-based intervention (Carer eSupport). In addition, we proposed a novel framework for the development of a web-based intervention aimed at promoting the well-being of informal caregivers. METHODS: Focus groups were conducted with 15 informal caregivers and 13 health care professionals. Both informal caregivers and health care professionals were recruited from 3 university hospitals in Sweden. We adopted a thematic data analysis process to analyze the data. RESULTS: We investigated informal caregivers' needs, critical factors for adoption, and desired functionalities of Carer eSupport. A total of 4 major themes, including information, web-based forum, virtual meeting place, and chatbot, emerged and were discussed by informal caregivers and health care professionals for Carer eSupport. However, most study participants did not like the idea of a chatbot for asking questions and retrieving information and expressed their concerns such as a lack of trust in robotic technologies and missing human contact while communicating with chatbots. The results from the focus groups were discussed through the lens of positive design research approaches. CONCLUSIONS: This study provided an in-depth understanding of informal caregivers' contexts and their preferred functions for a web-based intervention (Carer eSupport). Using the theoretical foundation of designing for well-being and positive design in the informal caregiving context, we proposed a positive design framework to support informal caregivers' well-being. Our proposed framework might be helpful for human-computer interaction and user experience researchers to design meaningful eHealth interventions with a clear focus on users' well-being and positive emotions, especially for informal caregivers of patients with HNC. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-057442.

Monitoring following acute stroke should be improved. / Overvåkning etter akutt hjerneslag bør bli bedre.

Many serious complications following acute stroke can be prevented and treated. This requires close and systematic monitoring following stroke.

Barriers to and facilitators for making emergency calls - a qualitative interview study of stroke patients and witnesses.

BACKGROUND AND OBJECTIVES: Early access to hospital for diagnosis and treatment is strongly recommended for patients with acute stroke. Unfortunately, prehospital delay frequently occurs. The aim of the current study was to gain in-depth insight into patient experience and behavior in the prehospital phase of a stroke. METHODS: We conducted qualitative interviews with a purposive sample of 11 patients and six witnesses within four weeks post stroke. The interviews were audio recorded, transcribed, and analyzed utilizing Systematic Text Condensation. RESULTS: The material was classified according to two main categories each containing three subgroups. The first category contained the diversity of sudden changes that all participants noticed. The subgroups were confusing functional changes, distinct bodily changes and witnesses' observations of abnormal behavior or signs. The second category was delaying and facilitating factors. To trivialize or deny stroke symptoms, or having a high threshold for contacting emergency services, led to time delay. Factors facilitating early contact were severe stroke symptoms, awareness of the consequences of stroke or a witness standing by when the stroke occurred. CONCLUSIONS: Prehospital delays involved interrelated elements: (1) Difficulties in recognition of a stroke when symptoms were mild, odd and/or puzzling; (2) Recognition of a stroke or need for medical assistance were facilitated by interaction/communication; (3) High threshold for calling emergency medical services, except when symptoms were severe. The findings may be helpful in planning future public stroke campaigns and in education and training programs for health personnel.

Internet-based support for informal caregivers to individuals with head and neck cancer (Carer eSupport): a study protocol for the development and feasibility testing of a complex online intervention.

INTRODUCTION: It is strongly recommended that randomised controlled trials are preceded with an exploration of the needs of the target population and feasibility testing of the intervention. The present study protocol is set out to describe these steps in the development of a complex intervention.The past decades' transition of care from inpatient to outpatient settings has increased the complexity of caregivers' responsibilities, which they may not be prepared for. There is a need to support informal caregivers (ICs) to prepare them for caregiving and decrease the caregiver burden. The main aim of this study is to describe the development of an internet-based intervention (Carer eSupport) to improve ICs' ability to support individuals with head and neck cancer and to describe the testing of the feasibility and acceptability of Carer eSupport. METHODS AND ANALYSIS: This is a multicentre study involving the ear, nose and throat clinics and the oncology and radiotherapy clinics at three university hospitals. The study protocol comprises two phases, development and feasibility testing, using the Medical Research Council framework for developing a complex intervention. Carer eSupport will be based on the results from focus group discussions with ICs and healthcare professionals (planned for n=6-8 in respective groups) and scientific evidence, the Social Cognitive Theory and the Theory of Acceptance and Use of Technology. The feasibility testing will include 30 ICs who will have access to Carer eSupport for 1 month. The feasibility testing will be evaluated with a mixed-method design. ETHICS AND DISSEMINATION: All procedures have been approved by the Ethics Committee at Uppsala University (Dnr: 2020-04650). Informed consent will be obtained before enrolment of patients, their ICs and healthcare staff. The feasibility testing is registered at Clinicaltrials.gov (Identifier: NCT05028452). Findings will be disseminated in peer-reviewed journal publications. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (Identifier: NCT05028452).

Brain monitoring in hospitals needs to be strengthened. / Hjerneovervåking i sykehusene må styrkes.

Careful brain monitoring saves lives and is beneficial to patients' health. Nevertheless, Norway lacks guidelines for brain monitoring in hospitals.

Re-Establishment Techniques and Transplantations of Charophytes to Support Threatened Species.

Re-establishment of submerged macrophytes and especially charophyte vegetation is a common aim in lake management. If revegetation does not happen spontaneously, transplantations may be a suitable option. Only rarely have transplantations been used as a tool to support threatened submerged macrophytes and, to a much lesser extent, charophytes. Such actions have to consider species-specific life strategies. K-strategists mainly inhabit permanent habitats, are perennial, have low fertility and poor dispersal ability, but are strong competitors and often form dense vegetation. R-strategists are annual species, inhabit shallow water and/or temporary habitats, and are richly fertile. They disperse easily but are weak competitors. While K-strategists easily can be planted as green biomass taken from another site, rare R-strategists often must be reproduced in cultures before they can be planted on-site. In Sweden, several charophyte species are extremely rare and fail to (re)establish, though apparently suitable habitats are available. Limited dispersal and/or lack of diaspore reservoirs are probable explanations. Transplantations are planned to secure the occurrences of these species in the country. This contribution reviews the knowledge on life forms, dispersal, establishment, and transplantations of submerged macrophytes with focus on charophytes and gives recommendations for the Swedish project.

Long-Term Survival, Causes of Death, and Trends in 5-Year Mortality After Intracerebral Hemorrhage: The Tromsø Study.

BACKGROUND AND PURPOSE: Data on long-term survival after intracerebral hemorrhage (ICH) are scarce. In a population-based nested case-control study, we compared long-term survival and causes of death within 5 years in 30-day survivors of first-ever ICH and controls, assessed the impact of cardiovascular risk factors on 5-year mortality, and analyzed time trend in 5-year mortality in ICH patients over 2 decades. METHODS: We included 219 participants from the population-based Tromsø Study, who after the baseline participation had a first-ever ICH between 1994 to 2013 and 1095 age- and sex-matched participants without ICH. Cumulative survival was presented using the Kaplan-Meier method. Hazard ratios (HRs) for mortality and for the association between cardiovascular risk factors and 5-year mortality in 30-day survivors were estimated by stratified Cox proportional hazards models. Trend in 5-year mortality was assessed by logistic regression. RESULTS: Risk of death during follow-up (median time, 4.8 years) was increased in the ICH group compared with controls (HR, 1.62 [95% CI, 1.27-2.06]). Cardiovascular disease was the leading cause of death, with a higher proportion in ICH patients (22.9% versus 9.0%; P<0.001). Smoking increased the risk of 5-year mortality in cases and controls (HR, 1.59 [95% CI, 1.15-2.19]), whereas serum cholesterol was associated with 5-year mortality in cases only (HR, 1.39 [95% CI, 1.04-1.86]). Use of anticoagulants at ICH onset increased the risk of death (HR, 2.09 [95% CI, 1.09-4.00]). There was no difference according to ICH location (HR, 1.15 [95% CI, 0.56-2.37]). Five-year mortality did not change during the study period (odds ratio per calendar year, 1.01 [95% CI, 0.93-1.09]). CONCLUSIONS: Survival rates were significantly lower in cases than in controls, driven by a 2-fold increased risk of cardiovascular death. Smoking, serum cholesterol, and use of anticoagulant drugs were associated with increased risk of death in ICH patients. Five-year mortality rates in ICH patients remained stable over time.

Equal palliative care for foreign-born patients: A national quality register study.

OBJECTIVES: To use data from a national quality register to investigate if there are differences relating to migrant background in the quality of end-of-life care of patients dying in Sweden. METHODS: A retrospective, comparative register-based study. In total, 81,418 deceased patients, over 18 years of age, registered in the Swedish Register of Palliative Care during 2017 and 2018, of expected death were included in the study. Of these, 72,012 were Swedish-born and 9,395 were foreign-born. Descriptive and analytical statistical methods were used. RESULTS: No general pattern of differences in quality regarding end-of-life care was found between Swedish- and foreign-born patients. There were several significant differences in various quality indicators but not in a specific direction. Sometimes, the quality indicators showed an advantage for Swedish-born patients but just as often, they were also favorable for foreign-born patients. Swedish-born patients had greater access to specialized palliative care than foreign-born patients. Foreign-born patients were more often cared for in general home care setting, despite a higher frequency of cancer diagnosis. SIGNIFICANCE OF RESULTS: Foreign-born patients were less likely to be cared for in specialized palliative care units and had poorer access to palliative care teams than Swedish-born patients, despite having a higher proportion of cancer diagnoses. However, no general pattern was found indicating that foreign-born patients were disadvantaged in the quality indicators measured in the present study. Perhaps, this is an indication that the palliative care in Sweden is individualized; nonetheless, the quality of end-of-life care would be higher if dying patients, regardless of country of birth, have better access to specialized palliative care.

Open-label study with the monoamine stabilizer (-)-OSU6162 in myalgic encephalomyelitis/chronic fatigue syndrome.

OBJECTIVES: The purpose of the present study was to investigate the safety and tolerability of the monoaminergic stabilizer (-)-OSU6162 in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). In addition, a potential therapeutic effect of (-)-OSU6162 in ME/CFS was evaluated by means of observer-rated scales and self-assessment rating scales. MATERIALS AND METHODS: In the current study using an open-label single-arm design ME/CFS patient received treatment with (-)-OSU6162 during 12 weeks. The patients received the following doses of (-)-OSU6162: 15 mg b.i.d. during the first 4-week period, up to 30 mg b.i.d. during the second 4-week period and up to 45 mg b.i.d. during the third 4-week period, with follow-up visits after 16 and 20 weeks. RESULTS: Out of 33 included patients, 28 completed the 12 weeks treatment period. (-)-OSU6162 was well tolerated; only one patient discontinued due to an adverse event. Vital signs and physical examinations showed no abnormal changes. Blood analyses showed an increase in serum prolactin. Therapeutically, improvements were seen on the Clinical Global Impression of Change scale, the FibroFatigue scale, the Mental Fatigue Scale, the Fatigue Severity Scale, Beck Depression Inventory, and the Short Form 36 Health Survey Questionnaire. CONCLUSIONS: (-)-OSU6162 is well tolerated in ME/CFS patients and shows promise as a novel treatment to mitigate fatigue and improve mood and health-related quality of life in ME/CFS. Obviously, the present results need to be confirmed in future placebo-controlled double-blind trials.

Effect of the monoaminergic stabiliser (-)-OSU6162 on mental fatigue following stroke or traumatic brain injury.

OBJECTIVE: The purpose of the present study was to evaluate the efficacy and safety of (-)-OSU6162 in doses up to 30 mg b.i.d. in patients suffering from mental fatigue following stroke or traumatic brain injury (TBI). METHODS: This 4 + 4 weeks double-blind randomised cross-over study included 30 patients afflicted with mental fatigue following a stroke or head trauma occurring at least 12 months earlier. Efficacy was assessed using the Mental Fatigue Scale (MFS), the Self-rating Scale for Affective Syndromes [Comprehensive Psychopathological Rating Scale (CPRS)], the Frenchay Activity Index (FAI), and a battery of neuropsychological tests. Safety was evaluated by recording spontaneously reported adverse events (AEs). RESULTS: There were significant differences on the patients' total FAI scores (p = 0.0097), the subscale FAI outdoor scores (p = 0.0243), and on the trail making test (TMT-B) (p = 0.0325) in favour of (-)-OSU6162 treatment. Principal component analysis showed a clear overall positive treatment effect in 10 of 28 patients; those who responded best to treatment had their greatest improvements on the MFS. Reported AEs were mild or moderate in severity and did not differ between the (-)-OSU6162 and the placebo period. CONCLUSION: The most obvious beneficial effects of (-)-OSU6162 were on the patients' activity level, illustrated by the improvement on the FAI scale. Moreover, a subgroup of patients showed substantial improvements on the MFS. Based on these observed therapeutic effects, in conjunction with the good tolerability of (-)-OSU6162, this compound may offer promise for treating at least part of the symptomatology in patients suffering from stroke- or TBI-induced mental fatigue.

STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage: Protocol for a randomised controlled trial.

BACKGROUND AND AIMS: Many patients with prior intracerebral haemorrhage have indications for antithrombotic treatment with antiplatelet or anticoagulant drugs for prevention of ischaemic events, but it is uncertain whether such treatment is beneficial after intracerebral haemorrhage. STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage will assess (i) the effects of long-term antithrombotic treatment on the risk of recurrent intracerebral haemorrhage and occlusive vascular events after intracerebral haemorrhage and (ii) whether imaging findings, like cerebral microbleeds, modify these effects. METHODS: STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage is a multicentre, randomised controlled, open trial of starting versus avoiding antithrombotic treatment after non-traumatic intracerebral haemorrhage, in patients with an indication for antithrombotic treatment. Participants with vascular disease as an indication for antiplatelet treatment are randomly allocated to antiplatelet treatment or no antithrombotic treatment. Participants with atrial fibrillation as an indication for anticoagulant treatment are randomly allocated to anticoagulant treatment or no anticoagulant treatment. Cerebral CT or MRI is performed before randomisation. Duration of follow-up is at least two years. The primary outcome is recurrent intracerebral haemorrhage. Secondary outcomes include occlusive vascular events and death. Assessment of clinical outcomes is performed blinded to treatment allocation. Target recruitment is 500 participants.Trial status: Recruitment to STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage is on-going. On 30 April 2020, 44 participants had been enrolled in 31 participating hospitals. An individual patient-data meta-analysis is planned with similar randomised trials.

Exercise: A positive feature on functioning in daily life during cancer treatment - Experiences from the Phys-Can study.

PURPOSE: Impaired functioning due to cancer treatment is a challenge for daily life. Exercise during treatment can improve functioning. However, research describing experiences of how exercise affects activities of daily life is limited. We aimed to explore how individuals with cancer receiving curative treatment and participating in an exercise intervention experienced their functioning in daily life. METHODS: Twenty-one participants were recruited from Phys-Can, an exercise intervention study. Semi-structured interviews were conducted after the intervention had finished, and data was analysed using thematic analysis. RESULTS: Two main themes evolved: "Striving to maintain a normal life in a new context" and "Struggling with impairments from side effects of cancer treatment". The supervised group exercise proved popular, and participants reported positive effects on physical and psychological functioning, as well as social and informative support from other participants. Participants struggled with impaired cognitive and physical functioning and exhaustion. They strove to maintain a normal life by adjusting their activities. CONCLUSIONS: Perceived physical and psychological benefits from exercise during cancer treatment suggest that exercise should be a part of cancer rehabilitation to facilitate activities and participation in daily life. Striving to maintain a normal life during cancer treatment is vital, and adjustments are needed to maintain activities and participation in daily life. Cancer nurses should motivate patients to engage in physical activity and encourage the introduction of exercise as part of their rehabilitation. They could also support patients in making adjustments to maintain functioning in daily life.

"Finding my own motivation" - A Mixed Methods Study of Exercise and Behaviour Change Support During Oncological Treatment.

BACKGROUND: Exercising during oncological treatment is beneficial but challenging for persons with cancer and may require strategies to increase motivation. Behaviour change support, including specific behaviour change techniques (BCTs), have been used to facilitate exercise in persons undergoing oncological treatment, but more detailed knowledge from an individual perspective is needed to inform clinical practice. The aims were to explore the motivational experiences of exercise combined with behaviour change support, and to describe how specific BCTs were valued among persons exercising during oncological treatment. METHODS: A mixed-methods study was conducted using semi-structured interviews (n = 18) and a questionnaire (n = 229). Participants with breast, colorectal or prostate cancer who completed or dropped out of a six-month exercise programme during oncological treatment were included. The interviews were analysed with thematic analysis and the questionnaire with descriptive statistics (median and interquartile range). RESULTS: The participants underwent a motivational process through the exercise programme. By experiencing 'Health gains and mastery', 'Learning', 'Affinity', 'Commitment', and 'Managing challenges', they found incentives that fostered feelings of autonomy, competence and relatedness, leading to an increased motivation to exercise. Social support from coaches, structuring the physical environment with scheduled sessions, self-monitoring with resistance training log, and feedback based on heart rate monitor and fitness tests were the most valued BCTs. CONCLUSIONS: The results indicate the importance of finding incentives and creating an environment that fosters autonomy, competence and relatedness to motivate persons to exercise during oncological treatment. Some BCTs appear particularly useful and may be used by health professionals to increase patients' motivation to exercise.

Identification of Anxiety and Depression Symptoms in Patients With Cancer: Comparison Between Short and Long Web-Based Questionnaires.

BACKGROUND: Physicians and nurses in cancer care easily fail to detect symptoms of psychological distress because of barriers such as lack of time, training on screening methods, and knowledge about how to diagnose anxiety and depression. National guidelines in several countries recommend routine screening for emotional distress in patients with cancer, but in many clinics, this is not implemented. By inventing screening methods that are time-efficient, such as digitalized and automatized screenings with short instruments, we can alleviate the burden on patients and staff. OBJECTIVE: The aim of this study was to compare Web-based versions of the ultrashort electronic Visual Analogue Scale (eVAS) anxiety and eVAS depression and the short Hospital Anxiety and Depression Scale (HADS) with Web-based versions of the longer Montgomery Åsberg Depression Rating Scale-Self-report (MADRS-S) and the State Trait Anxiety Inventory- State (STAI-S) with regard to their ability to identify symptoms of anxiety and depression in patients with cancer. METHODS: Data were obtained from a consecutive sample of patients with newly diagnosed (<6 months) breast, prostate, or colorectal cancer or with recurrence of colorectal cancer (N=558). The patients were recruited at 4 hospitals in Sweden between April 2013 and September 2015, as part of an intervention study administered via the internet. All questionnaires were completed on the Web at the baseline assessment in the intervention study. RESULTS: The ultrashort and short Web-based-delivered eVAS anxiety, eVAS depression and HADS were found to have an excellent ability to discriminate between persons with and without clinical levels of symptoms of anxiety and depression compared with recommended cutoffs of the longer instruments MADRS-S and STAI-S (area under the curve: 0.88-0.94). Cutoffs of >6 on HADS anxiety and >7 hundredths (hs) on eVAS anxiety identified patients with anxiety symptoms with high accuracy. For HADS depression, at a cutoff of >5 and eVAS depression at a cutoff of >7 hs, the accuracy was very high likewise. CONCLUSIONS: The use of the short and ultrashort tools, eVAS and HADS, may be a suitable initial method of Web-based screening in busy clinical settings. However, there are still a proportion of patients who lack access to the internet or the ability to use it. There is a need to find solutions for this group to find all the patients with psychological distress.

Safety and Outcomes of Tenecteplase in Moderate and Severe Ischemic Stroke.

Background and Purpose- Tenecteplase represents a promising alternative to alteplase as thrombolytic treatment in acute ischemic stroke. There are limited data on tenecteplase 0.4 mg/kg in patients with increased stroke severity. We aimed to assess safety and efficacy of tenecteplase 0.4 mg/kg in patients with moderate and severe ischemic stroke. Methods- NOR-TEST (Norwegian Tenecteplase Stroke Trial) was a phase III trial designed to investigate the safety and efficacy of tenecteplase 0.4 mg/kg versus alteplase 0.9 mg/kg in ischemic stroke. In this post hoc analysis, moderate stroke was defined as admission National Institutes of Health Stroke Scale; 6 to 14 and severe stroke as National Institutes of Health Stroke Scale; ≥15. Rates of favorable outcome at 90 days, symptomatic intracerebral hemorrhage (sICH), and mortality after 7 and 90 days were assessed. Results- In patients with moderate stroke (n=261), there were no differences in rates of favorable outcome, sICH, or mortality between tenecteplase and alteplase. In patients with severe stroke (n=87), there were no differences in outcome, frequency of sICH, or mortality at 7 days, but all-cause mortality at 90 days was increased in patients treated with tenecteplase (10 [26.3%] versus 4 [9.1%]; P=0.045). One patient died of sICH in the tenecteplase group, and 2 patients died of sICH in the alteplase group. Conclusions- Rates of favorable outcome and sICH were similar between treatment groups in patients with moderate and severe stroke. Mortality after 90 days was increased in patients with severe stroke receiving tenecteplase. Future studies assessing tenecteplase 0.4 mg/kg should monitor safety parameters closely in patients with severe stroke. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT01949948.

The impact of risk factor trends on intracerebral hemorrhage incidence over the last two decades-The Tromsø Study.

BACKGROUND: Studies on the relationship between temporal trends in risk factors and incidence rates of intracerebral hemorrhage are scarce. AIMS: To analyze temporal trends in risk factors and incidence rates of intracerebral hemorrhage using individual data from a population-based study. METHODS: We included 28,167 participants of the Tromsø Study enrolled between 1994 and 2008. First-ever intracerebral hemorrhages were registered through 31 December 2013. Hazard ratios (HRs) for intracerebral hemorrhage were analyzed by Cox proportional hazards models, risk factor levels over time by generalized estimating equations, and incidence rate ratios (IRR) by Poisson regression. RESULTS: We registered 219 intracerebral hemorrhages. Age, male sex, systolic blood pressure (BP), diastolic BP, and hypertension were associated with intracerebral hemorrhage. Hypertension was more strongly associated with non-lobar intracerebral hemorrhage (HR 5.08, 95% CI 2.86-9.01) than lobar intracerebral hemorrhage (HR 1.91, 95% CI 1.12-3.25). In women, incidence decreased significantly (IRR 0.46, 95% CI 0.23-0.90), driven by a decrease in non-lobar intracerebral hemorrhage. Incidence rates in men remained stable (IRR 1.27, 95% CI 0.69-2.31). BP levels were lower and decreased more steeply in women than in men. The majority with hypertension were untreated, and a high proportion of those treated did not reach treatment goals. CONCLUSIONS: We observed a significant decrease in intracerebral hemorrhage incidence in women, but not in men. A steeper BP decrease in women may have contributed to the diverging trends. The high proportion of untreated and sub-optimally treated hypertension calls for improved strategies for prevention of intracerebral hemorrhage.