| 1. |
- Isaksson, Eva, et al.
(författare)
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Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel
- 2019
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Ingår i: Trials. - : BMC. - 1745-6215. ; 20:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Many randomised controlled trials (RCT) fail to meet their recruitment goals. Study personnel play a key role in recruitment. The aim of this study was to identify successful strategies that study personnel consider to be important in patient recruitment to RCT. Methods: We constructed a questionnaire based on the literature, discussions with colleagues and our own experience as trialists. The survey was named "What is Important for Making a Study Successful questionnaire" (WIMSS-q). Our target group was the study personnel in the ongoing EFFECTS study. The questionnaire was sent out electronically to all physicians and nurses (n = 148). Success factors and barriers were divided according to patient, centre and study level, respectively. Results: Responses were received from 94% of the study personnel (139/148). The five most important factors at centre level for enhancing recruitment were that the research question was important (97%), a simple procedure for providing information and gaining consent (92%), a highly engaged local principal investigator and research nurse (both 87%), and that study-related follow-ups are practically feasible and possible to coordinate with the clinical follow-up (87%). The most significant barrier at the local centre was lack of time and resources devoted to research (72%). Important patient-related barriers were fear of side effects (35%) and language problems (30%). Conclusions: For recruitment in an RCT to be successful, the research question must be relevant, and the protocol must be simple and easy to implement in the daily routine.
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| 2. |
- Isaksson, Eva, et al.
(författare)
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Validation of the Simplified Modified Rankin Scale Questionnaire
- 2020
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Ingår i: European Neurology. - : S. Karger. - 0014-3022 .- 1421-9913. ; 83:5, s. 493-499
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: The modified Rankin scale (mRS) is the most common assessment tool for measuring overall functional outcome in stroke studies. The traditional way of using mRS face-to-face is time- and cost-consuming. The aim of this study was to test the validity of the Swedish translation of the simplified modified Rankin scale questionnaire (smRSq) as compared with the mRS assessed face-to-face 6 months after a stroke.Methods: Within the ongoing EFFECTS trial, smRSq was sent out to 108 consecutive stroke patients 6 months after a stroke. The majority, 90% (97/108), of the patients answered the questionnaire; for the remaining 10%, it was answered by the next of kin. The patients were assessed by face-to-face mRS by 7 certified healthcare professionals at 4 Swedish stroke centres. The primary outcome was assessed by Cohen's kappa and weighted kappa.Results: There was good agreement between postal smRSq, answered by the patients, and the mRS face-to-face; Cohen's kappa was 0.43 (CI 95% 0.31-0.55), weighted kappa was 0.64 (CI 95% 0.55-0.73), and Spearman rank correlation was 0.82 (p < 0.0001). In 55% (59/108), there was full agreement, and of the 49 patients not showing exact agreement, 44 patients differed by 1 grade and 5 patients had a difference of 2 grades.Discussion/Conclusion: Our results show good validity of the postal smRSq, answered by the patients, compared with the mRS carried out face-to-face at 6 months after a stroke. This result could help trialists in the future simplify study design and make multicentre trials and quality registers with a large number of patients more feasible and time-saving.
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| 3. |
- Lundström, Erik, 1964-, et al.
(författare)
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Effects of Fluoxetine on Outcomes at 12 Months After Acute Stroke Results From EFFECTS, a Randomized Controlled Trial
- 2021
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Ingår i: Stroke. - : Ovid Technologies (Wolters Kluwer Health). - 0039-2499 .- 1524-4628. ; 52:10, s. 3082-3087
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND PURPOSE: The EFFECTS (Efficacy of Fluoxetine-a Randomised Controlled Trial in Stroke) recently reported that 20 mg fluoxetine once daily for 6 months after acute stroke did not improve functional outcome but reduced depression and increased fractures and hyponatremia at 6 months. The purpose of this predefined secondary analysis was to identify if any effects of fluoxetine were maintained or delayed over 12 months. METHODS: EFFECTS was an investigator-led, randomized, placebo-controlled, double-blind, parallel group trial in Sweden that enrolled adult patients with stroke. Patients were randomized to 20 mg oral fluoxetine or matching placebo for 6 months and followed for another 6 months. The primary outcome was functional outcome (modified Rankin Scale), at 6 months. Predefined secondary outcomes for these analyses included the modified Rankin Scale, health status, quality of life, fatigue, mood, and depression at 12 months. RESULTS: One thousand five hundred patients were recruited from 35 centers in Sweden between 2014 and 2019; 750 were allocated fluoxetine and 750 placebo. At 12 months, modified Rankin Scale data were available in 715 (95%) patients allocated fluoxetine and 712 (95%) placebo. The distribution of modified Rankin Scale categories was similar in the 2 groups (adjusted common odds ratio, 0.92 [95% CI, 0.76-1.10]). Patients allocated fluoxetine scored worse on memory with a median value of 89 (interquartile range, 75-100) versus 93 (interquartile range, 82-100); P=0.0021 and communication 93 (interquartile range, 82-100) versus 96 (interquartile range, 86-100); P=0.024 domains of the Stroke Impact Scale compared with placebo. There were no other differences in secondary outcomes. CONCLUSIONS: Fluoxetine after acute stroke had no effect on functional outcome at 12 months. Patients allocated fluoxetine scored worse on memory and communication on the Stroke Impact Scale compared with placebo, but this is likely to be due to chance.
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| 4. |
- Lundström, Erik, Docent, 1964-, et al.
(författare)
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Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden
- 2020
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Ingår i: Trials. - Uppsala : Springer Science and Business Media LLC. - 1745-6215. ; 21:1
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Tidskriftsartikel (refereegranskat)abstract
- Studies have suggested that fluoxetine might improve neurological recovery after stroke, but the results remain inconclusive. The EFFECTS (Efficacy oF Fluoxetine - a randomisEd Controlled Trial in Stroke) reached its recruitment target of 1500 patients in June 2019. The purpose of this article is to present all amendments to the protocol and describe how we formed the EFFECTS trial collaboration in Sweden. Methods In this investigator-led, multicentre, parallel-group, randomised, placebo-controlled trial, we enrolled non-depressed stroke patients aged 18 years or older between 2 and 15 days after stroke onset. The patients had a clinical diagnosis of stroke (ischaemic or intracerebral haemorrhage) with persisting focal neurological deficits. Patients were randomised to fluoxetine 20 mg or matching placebo capsules once daily for 6 months. Results Seven amendments were made and included clarification of drug interaction between fluoxetine and metoprolol and the use of metoprolol for severe heart failure as an exclusion criterion, inclusion of data from central Swedish registries and the Swedish Stroke Register, changes in informed consent from patients, and clarification of design of some sub-studies. EFFECTS recruited 1500 patients at 35 centres in Sweden between 20 October 2014 and 28 June 2019. We plan to unblind the data in January 2020 and report the primary outcome in May 2020. Conclusion EFFECTS will provide data on the safety and efficacy of 6 months of treatment with fluoxetine after stroke in a Swedish health system setting. The data from EFFECTS will also contribute to an individual patient data meta-analysis.
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| 5. |
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| 6. |
- Nyman, Emma, et al.
(författare)
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Carotid wall echogenicity at baseline associates with accelerated vascular aging in a middle-aged population
- 2023
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Ingår i: The International Journal of Cardiovascular Imaging. - : Springer Science+Business Media B.V.. - 1569-5794 .- 1875-8312. ; 39:3, s. 575-583
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Tidskriftsartikel (refereegranskat)abstract
- Ultrasonic echolucent carotid intima-media (IM) complex and accelerated progression of carotid intima mediathickness (cIMT) have both separately been shown to predict future cardiovascular events. The aim of this studywas to evaluate if the echogenicity of the IM-complex is associated with the 3-year progression of cIMT. B-modeultrasound images captured at baseline and 3-year follow-up in the ‘Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention’ (VIPVIZA) trial were included (n: 3154). The bilateral mean cIMT and IM-echogenicity by greyscale median (GSM) were measured in the common carotid artery. Associations between IM-GSM at baseline and the 3-year cIMT progression were investigated using linear regression models for the whole population and stratified by sex, age and VIPVIZA study group (intervention versus control). In addition, adjusted analyses for confounding factors were performed. Unadjusted analysis showed that decreased IM-GSM at baseline was associated with increased progression of cIMT (p < 0.001). Stratified by age, the association was significant among 40 (p < 0.001) and 60 years old (p < 0.001). The association was statistically significant in both sexes and on comparison of VIPVIZA study subgroups. Adjustments for confounding factors did not alter the estimated relationship between IM-GSM and cIMT progression. Echolucent carotid intima media at baseline associates with increased 3-year cIMT progression among an asymptomatic, middle-aged population. Echogenicity of the intima media may identify individuals at risk for accelerated vascular aging.
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| 7. |
- Nyman, Emma, et al.
(författare)
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Reduced progression of carotid intima media thickness by personalised pictorial presentation of subclinical atherosclerosis in VIPVIZA : A randomised controlled trial
- 2023
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Ingår i: Clinical Physiology and Functional Imaging. - : John Wiley & Sons. - 1475-0961 .- 1475-097X. ; 43:4, s. 232-241
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Reduced progression of atherosclerosis can decrease the risk of cardiovascular disease (CVD). This study aimed at evaluating the effect of a pictorial intervention showing atherosclerotic severity on the progression of carotid atherosclerosis.Methods: A prospective randomised open-label blinded end-point trial with participants aged 40–60 years enroled from a routine CVD prevention programme. The intervention group (n: 1575) and their treating physicians received an image based presentation of subclinical atherosclerotic severity measured by carotid ultrasound. The control group (n: 1579) did not receive any information about ultrasound results. Carotid ultrasound at baseline and at 3-year follow-up contained plaque detection and measurements of carotid intima media thickness (cIMT). The left, right and bilateral-mean-cIMT, plaque prevalence and total plaque area (TPA) at 3-year follow-up were compared between groups. Significance level was set to p = 0.01 to adjust for multiple comparisons.Results: The intervention group revealed reduced cIMT progression in the left-mean-cIMT of −0.011 mm (p = 0.001) compared with the control group. The intervention effect on cIMT progression was most prominent in individuals with increased cIMT and plaque prevalence at baseline (−0.021 mm, p = 0.005). There were no differences in progression between groups for the right-and bilateral-mean-cIMT (−0.005 mm, p = 0.223 and −0.005 mm, p = 0.036, respectively), nor any differences between groups for plaque prevalence or TPA (odds ratio 0.88, p = 0.09 and 0.89, p = 0.21, respectively).Conclusion: Pictorial presentation of subclinical atherosclerotic severity sent to both the individual and their treating physician resulted in significantly reduced left cIMT progression. Pictorial presentation has the potential to increase adherence in CVD prevention.
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| 8. |
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| 9. |
- Aronsson, Mattias, et al.
(författare)
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Cost-effectiveness of endovascular thrombectomy in patients with acute ischemic stroke.
- 2016
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Ingår i: Neurology. - : American Academy of neurology. - 0028-3878 .- 1526-632X. ; 86:11, s. 1053-9
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Tidskriftsartikel (refereegranskat)abstract
- Objective:To evaluate the cost-effectiveness of adding endovascular thrombectomy to standard care in patients with acute ischemic stroke.Methods:The cost-effectiveness analysis of endovascular thrombectomy in patients with acute ischemic stroke was based on a decision-analytic Markov model. Primary outcomes from ESCAPE, Extending the Time for Thrombolysis in Emergency Neurological Deficits-Intra-Arterial (EXTEND-IA), Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN), Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours (REVASCAT), and Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) along with data from published studies and registries were used in this analysis. We used a health care payer perspective and a lifelong time horizon to estimate costs and effects.Results:The model showed that adding thrombectomy with stent retrievers to guideline-based care (including IV thrombolysis) resulted in a gain of 0.40 life-years and 0.99 quality-adjusted life-years along with a cost savings of approximately $221 per patient. The sensitivity analysis showed that the results were not sensitive to changes in uncertain parameters or assumptions.Conclusions:Adding endovascular treatment to standard care resulted in substantial clinical benefits at low costs. The results were consistent throughout irrespective of whether data from ESCAPE, EXTEND-IA, MR CLEAN, REVASCAT, or SWIFT PRIME were used in this model.
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| 10. |
- Barut, Oya, et al.
(författare)
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Calcifications in the neck region of patients with carotid artery stenosis : a computed tomography angiography study of topographic anatomy
- 2020
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Ingår i: Oral surgery, oral medicine, oral pathology and oral radiology. - : Elsevier. - 2212-4403 .- 2212-4411. ; 129:5, s. 523-530
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The aim of this study was to map the vertical locations of calcified carotid plaques (CCPs), osseous anatomic structures, and calcified soft tissues in the area of the carotid artery, determine to what extent CCPs are superimposed on the cervical spine in coronal images, and analyze the differences between men and women.Study Design: Computed tomography angiography (CTA) scans of 79 patients were studied. CCPs were discovered in 152 of the total 158 neck sides. Evaluations were performed by using sagittal and coronal reformatted CTA images with maximum intensity projection.Results: Most of the calcified anatomic structures studied, including the carotid bifurcation, were found in close relationship to the level of the third and fourth cervical vertebrae. In the coronal view, all or most of the areas of the CCPs were superimposed on the cervical spine in 22 of 44 (50%) neck sides with CCP in women and in 37 of 108 (34.2%) in men (P = .070).Conclusions: The carotid bifurcation is in close proximity to various calcified anatomic structures. This should be taken into account when diagnosing CCPs in panoramic radiographs. In the coronal view, CCPs and the cervical spine are often superimposed; thus, coronal images are not recommended for confirmation of putative carotid calcifications diagnosed on the basis of panoramic radiographs.
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| 11. |
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| 12. |
- Bengtsson, Anna, 1973-, et al.
(författare)
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Multi-view carotid ultrasound is stronger associated with cardiovascular risk factors than presence of plaque or single carotid intima media thickness measurements in subclinical atherosclerosis
- 2023
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Ingår i: The International Journal of Cardiovascular Imaging. - : Springer Nature. - 1569-5794 .- 1875-8312. ; 39:8, s. 1461-1471
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Tidskriftsartikel (refereegranskat)abstract
- We aimed to explore the prevalence of atherosclerosis by using multi-view ultrasound examination of the carotid arteries and its association with clinical risk factors in a middle-aged population at low to intermediate risk of cardiovascular disease (CVD). Carotid vascular ultrasound was performed in 3532 participants in the VIPVIZA trial. Mean and maximal carotid intima media thickness (cIMT) at prespecified angles and plaque presence were examined on the left and right side. Associations between CVD risk factors and ultrasound variables were quantified by partial least squares (PLS) regression. A combined ultrasound variable was computed using weights of the first PLS component. Associations between CVD risk factors and the combined multi-view ultrasound variable, single cIMT and plaque measurements, respectively, were determined using linear regression modelling. The participants’ mean age was 55.7 years and 52.9% were women. Plaque prevalence was 51.1% in men and 39.0% in women. cIMT was higher in men than in women and in the left compared with the right carotid artery. The strongest association of CVD risk factors was observed with the combined multi-view ultrasound variable (R2 = 24%), compared with single cIMT variables (R2 = 14–18%) and plaque presence (R2 = 15%). The pattern was similar in both sexes. The association with CVD risk factors and the combined ultrasound variable was stronger in 40-year olds (R2 = 22%) compared with 50- or 60-year olds (R = 12%). CVD risk factors are stronger associated with a combined ultrasound variable than plaque presence or single cIMT measures suggesting that carotid multi-view ultrasonography better captures the focality of early atherosclerosis. Clinical Trial Registration: ClinicalTrials.gov, number NCT01849575. May 8, 2013.
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| 13. |
- Bengtsson, Anna, 1973-
(författare)
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Pictorial presentation of subclinical atherosclerosis : a measure to reduce the risk for cardiovascular disease
- 2021
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The overall aim was improved cardiovascular disease (CVD) prevention through the VIPVIZA intervention. This includes the provision of pictorial information of subclinical atherosclerosis to participants and their general practitioners (GPs), follow-up phone call, and written information to the participant. VIPVIZA is a Prospective Randomized Open Blinded End-point (PROBE) trial nested within VIP, a CVD prevention program in primary health care in Västerbotten county, Sweden. Middle-aged individuals at low/intermediate CVD risk were enrolled to VIPVIZA and randomized 1:1 to an intervention (n=1749) or control group (n=1783 who received no pictorial or other information). Preventive measures were managed within primary health care.At baseline, clinical risk factors were measured and carotid ultrasound examination was performed. The prevalence of subclinical atherosclerotic disease was assessed as intima media thickness and presence of plaque. The association between clinical risk factors and measures of subclinical atherosclerosis was investigated. In addition to conventional risk factor-based risk evaluation, the impact of the VIPVIZA intervention on CVD risk, traditional risk factors and pharmacological treatment was evaluated after 1 and 3 years. Individual interviews were conducted with 15 GPs to explore how a pictorial representation of subclinical atherosclerosis affects physicians in their perception and communication of CVD risk. The interviews were analyzed by qualitative content analysis.The plaque prevalence was 44.7% in this population. Clinical risk factors explained more of the variation in a combined ultrasound measurement than single measurements. The results up to three years showed a VIPVIZA intervention effect, with lower and sustained CVD risk in the intervention as compared to the control group. The effect was partly mediated by differences in intake of lipid-lowering medication and partly by lifestyle behaviour. The GPs described their risk assessment and patients’ risk perception as more accurate with the VIPVIZA intervention. Informing patients about examination results prior to a consultation can facilitate shared decision-making and enhance adherence to preventive measures.The results show that the VIPVIZA intervention reduces CVD risk over three years. In the long run this has the potential to reduce the incidence of CVD events.
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| 14. |
- Bengtsson, Anna, 1973-, et al.
(författare)
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The beneficial effect over 3 years by pictorial information to patients and their physician about subclinical atherosclerosis and cardiovascular risk : results from the VIPVIZA randomized clinical trial
- 2021
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Ingår i: American Journal of Preventive Cardiology. - : Elsevier. - 2666-6677. ; 7
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Non-adherence to guidelines and preventive measures is a major challenge, particularly so to ob- tain long-term adherence to lifestyle changes and recommended medication. The objective was to investigate if pictorial information regarding subclinical carotid atherosclerosis provided to individuals and physicians gave sustained effects on cardiovascular risk beyond the previously reported effect after 1 year and up to 3 years. Methods: A Prospective Randomized Open Blinded End-point (PROBE) trial. Within a CVD prevention program in Västerbotten County, Sweden, 3532 healthy individuals aged 40, 50 or 60 years were enrolled and 1:1 ran- domized to intervention ( n = 1749; pictorial information with additional prevention materials to participants and physicians) or control group ( n = 1783; no pictorial information to participants and physicians). Preventive measures were managed within primary care. Participants were investigated at baseline during 2013–2016 and at follow-up after 1 and 3 years. Results: A beneficial effect on cardiovascular risk was observed at 3-year follow-up; Framingham Risk Score (FRS) was 13.38 for the intervention group and 14.08 for the control group ( p = 0.047) and SCORE was 1.69 vs. 1.82 ( p = 0.022). The effect observed at 1-year was sustained over 3 years after adjustment for sex and education and more pronounced among participants with a severe atherosclerotic picture at baseline.Conclusions: This study provides evidence of sustained beneficial effects on the adherence to prevention guidelines over 3 years of pictorial information about subclinical carotid atherosclerosis, resulting in lower cardiovascular risk regardless of sex and educational level. Direct visualization of the underlying still subclinical atherosclerotic disease, rather than just indirect information about risk factors and statistical risk of future myocardial infarction, stroke and death, is one way to tackle the problem of non-adherence to prevention of cardiovascular diseases.
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| 15. |
- Bytyçi, Ibadete, et al.
(författare)
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Carotid Atherosclerosis in Predicting Coronary Artery Disease : A Systematic Review and Meta-Analysis
- 2021
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Ingår i: Arteriosclerosis, Thrombosis and Vascular Biology. - : Lippincott Williams & Wilkins. - 1079-5642 .- 1524-4636. ; 41:4, s. e224-e237
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Forskningsöversikt (refereegranskat)abstract
- Objective: This meta-Analysis aims to compare the relationship between phenotypic manifestation of coronary and carotid atherosclerosis using available imaging techniques. Approach and Results: We searched all electronic databases until October 2020 for studies which reported relationship between carotid and coronary atherosclerosis. The primary end point was correlation between carotid intima-media thickness (CIMT) and carotid plaque features (calcification and lipid-rich necrotic core) with coronary artery disease (CAD). Secondary end points included carotid pathology that predicts CAD. Eighty-nine papers with 22 683 patients comparing carotid and coronary atherosclerosis were included in the analysis. CIMT was increased linearly with severity of CAD irrespective of its significance (P<0.001), mono versus 2 vessel disease (P=0.003), and 2 versus multivessel disease (P<0.001). Carotid plaque presence and calcification were less, and lipid-rich necrotic core was highly prevalent in nonsignificant versus significant CAD (P<0.001, P=0.03, P<0.001, respectively). Moderate correlation was found between CIMT and severity of CAD (r=0.60, P<0.001) and the number of diseased vessels (r=0.49, P<0.001). There was a moderate correlation between carotid and coronary stenosis (r=0.53, P<0.001) and between carotid and coronary calcification (r=0.61, P<0.001). CIMT ≥1.0 mm with a summary sensitivity of 77% and summary specificity of 72% and respective values of 80% and 67% for carotid plaque were the best predictors of CAD, irrespective of the technique used for its diagnosis. Conclusions: These results support the concept that atherosclerosis affects both carotid and coronary systems, although not always in identical phenotypic manner. These findings highlight the beneficial examination of carotid arteries whenever CAD is suspected.
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| 16. |
- Engdahl, Johan, et al.
(författare)
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Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding : the AF SPICE protocol
- 2023
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 13:11
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.Methods and analysis: AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥ 70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24-72hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023-2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.Ethics and dissemination: Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021-02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice. Trial registration number NCT05134454.
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| 17. |
- Ennab Vogel, Nicklas, et al.
(författare)
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Optimized density and locations of stroke centers for improved cost effectiveness of mechanical thrombectomy in patients with acute ischemic stroke
- 2024
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Ingår i: Journal of NeuroInterventional Surgery. - : BMJ Publishing Group Ltd. - 1759-8478 .- 1759-8486. ; 16, s. 156-162
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Tidskriftsartikel (refereegranskat)abstract
- Background: Despite the proven cost effectiveness of mechanical thrombectomy (MT) in patients with acute ischemic stroke (AIS) due to large vessel occlusion, treatment within 6 hours from symptom onset remains inaccessible for many patients. We aimed to find the optimal number and location of treatment facilities with respect to the cost effectiveness of MT in patients with AIS, first by the most cost effective implementation of comprehensive stroke centers (CSCs), and second by the most cost effective addition of complementary thrombectomy capable stroke centers (TSCs).Methods: This study was based on nationwide observational data comprising 18 793 patients with suspected AIS potentially eligible for treatment with MT. The most cost effective solutions were attained by solving the p median facility location-allocation problem with the objective function of maximizing the incremental net monetary benefit (INMB) of MT compared with no MT in patients with AIS. Deterministic sensitivity analysis (DSA) was used as the basis of the results analysis.Results: The implementation strategy with seven CSCs produced the highest annual INMB per patient of all possible solutions in the base case scenario. The most cost effective implementation strategy of the extended scenario comprised seven CSCs and four TSCs. DSA revealed sensitivity to variability in MT rate and the maximum willingness to pay per quality adjusted life year gained.Conclusion: The combination of optimization modeling and cost effectiveness analysis provides a powerful tool for configuring the extent and locations of CSCs (and TSCs). The most cost effective implementation of CSCs in Sweden entails 24/7 MT services at all seven university hospitals.
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| 18. |
- Ennab Vogel, Nicklas, et al.
(författare)
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Prediction modelling the impact of onset to treatment time on the modified Rankin Scale score at 90 days for patients with acute ischaemic stroke
- 2022
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Ingår i: BMJ Neurology Open. - : BMJ. - 2632-6140. ; 4:2
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Shortening the time from stroke onset to treatment increases the effectiveness of endovascular stroke therapies. Aim This study aimed to predict the modified Rankin Scale score at 90 days post-stroke (mRS-90d score) in patients with acute ischaemic stroke (AIS) with respect to four types of treatment: conservative therapy (CVT), intravenous thrombolysis only (IVT), mechanical thrombectomy only (MT) and pretreatment with IVT before MT (IVT+MT). Patients and methods This nationwide observational study included 124 484 confirmed cases of acute stroke in Sweden over 6 years (2012-2017). The associations between onset-to-treatment time (OTT), patient age and hospital admission National Institutes of Health Stroke Scale (NIHSS) score with the five-levelled mRS-90d score were retrospectively studied. A generalised linear model (GLM) was fitted to predict the mRS-90d scores for each patient group. Results The fitted GLM for CVT patients is a function of age and NIHSS score. For IVT, MT and IVT+MT patients, GLMs additionally employed OTT variables. By reducing the mean OTTs by 15 min, the number needed-to-treat (NNT) for one patient to make a favourable one-step shift in the mRS was 30 for IVT, 48 for MT and 21 for IVT+MT. Discussion and conclusion This study demonstrates linear associations of mRS-90d score with OTT for IVT, MT and IVT+MT, and shows in absolute effects measures that OTT reductions for IVT and/or MT produces substantial health gains for patients with AIS. Even moderate OTT reductions led to sharp drops in the NNT. © 2022 Author(s) (or their employer(s)).
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| 19. |
- Forfang, Elisabeth, et al.
(författare)
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Antithrombotic treatment after intracerebral hemorrhage : surveys among stroke physicians in Scandinavia and the United Kingdom
- 2023
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Ingår i: Health Science Reports. - : John Wiley & Sons. - 2398-8835. ; 6:1
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Tidskriftsartikel (refereegranskat)abstract
- Background and Aims: It is unclear whether patients with previous intracerebral hemorrhage (ICH) should receive antithrombotic treatment to prevent ischemic events. We assessed stroke physicians' opinions about this, and their views on randomizing patients in trials assessing this question.Methods: We conducted three web-based surveys among stroke physicians in Scandinavia and the United Kingdom.Results: Eighty-nine of 205 stroke physicians (43%) responded to the Scandinavian survey, 161 of 180 (89%) to the UK antiplatelet survey, and 153 of 289 (53%) to the UK anticoagulant survey. In Scandinavia, 19 (21%) stroke physicians were uncertain about antiplatelet treatment after ICH for ischemic stroke or transient ischemic attack (TIA) and 21 (24%) for prior myocardial infarction. In the United Kingdom, 116 (77%) were uncertain for ischemic stroke or TIA and 115 (717%) for ischemic heart disease. In Scandinavia, 32 (36%) were uncertain about anticoagulant treatment after ICH for atrial fibrillation, and 26 (29%) for recurrent deep vein thrombosis or pulmonary embolism. In the United Kingdom, 145 (95%) were uncertain about anticoagulants after ICH in at least some cases. In both regions combined, 191 of 250 (76%) would consider randomizing ICH survivors in a trial of starting versus avoiding antiplatelets, and 176 of 242 (73%) in a trial of starting versus avoiding anticoagulants.Conclusion: Considerable proportions of stroke physicians in Scandinavia and the United Kingdom were uncertain about antithrombotic treatment after ICH. A clear majority would consider randomizing patients in trials assessing this question. These findings support the need for such trials.
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| 20. |
- Garoff, Maria, 1979-, et al.
(författare)
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Bilateral vessel-outlining carotid artery calcifications in panoramic radiographs : an independent risk marker for vascular events
- 2019
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Ingår i: BMC Cardiovascular Disorders. - : BioMed Central. - 1471-2261 .- 1471-2261. ; 19:1
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: In odontology, panoramic radiographs (PRs) are regularly performed. PRs depict the teeth and jaws as well as carotid artery calcifications (CACs). Patients with CACs on PRs have an increased risk of vascular events compared to healthy controls without CACs, but this association is often caused by more vascular events and risk factors at baseline. However, the risk of vascular events has only been analyzed based on the presence of CACs, and not their shape. Thus, this study determined if the shape of CACs in PRs affects the risk of future vascular events.METHODS: The study cohort included 117 consecutive patients with CACs in PRs and 121 age-matched controls without CACs. CAC shape in PRs was dichotomized into bilateral vessel-outlining CACs and other CAC shapes. Participants were followed prospectively for an endpoint of vascular events including myocardial infarction, stroke, and vascular death.RESULTS: Patients with bilateral vessel-outlining CACs had more previous vascular events than those with other CAC shapes and the healthy controls (p < 0.001, χ2). The mean follow-up duration was 9.5 years. The endpoint was reached in 83 people. Patients with bilateral vessel-outlining CACs had a higher annual risk of vascular events (7.0%) than those with other CAC shapes (4.4%) and the controls (2.6%) (p < 0.001). In multivariate analysis, bilateral vessel-outlining CACs (hazard ratio: 2.2, 95% confidence interval: 1.1-4.5) were independent risk markers for the endpoint.CONCLUSIONS: Findings of bilateral vessel-outlining CACs in PRs are independent risk markers for future vascular events.
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| 21. |
- Gu, Thomas, et al.
(författare)
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Ny lovande behandling vid akut ischemisk stroke: Sonotrombolys kan förstärka effekten av intravenös trombolys : [Promising new treatment for acute ischemic stroke--Sonothrombolysis can enhance the effect of intravenous thrombolysis]
- 2015
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Ingår i: Läkartidningen. - : Sveriges läkarförbund. - 0023-7205 .- 1652-7518. ; 112
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Tidskriftsartikel (refereegranskat)abstract
- Intravenous thrombolysis has been a break-through for treatment of acute ischemic stroke. However, total recanalization is only achieved in 18%. Sonothrombolysis aims at enhancing the recanalization effect by adding continuous transcranial ultrasound. Sonothrombolysis may facilitate the recanalization rate without increased risk of intracerebral hemorrhage. This further results in decreased risk of disability compared with only intravenous thrombolysis. Intravenously applied micro-bubbles is an additive treatment to sonothrombolysis which might further increase the recanalization rate but perhaps at the expense of increased risk of intracerebral hemorrhage. In a case- series at Umeå Stroke Center, we report the results of the first 20 ischemic stroke patients treated with sonothrombolysis in Sweden. Our initial results look promising with recanalization rates similar to earlier published data. No intracerebral hemorrhage occurred among our sonothrombolysed patients.
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| 22. |
- Gustafsson, Nils, 1990-, et al.
(författare)
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Association of high cardiovascular risk and diabetes with calcified carotid artery atheromas depicted on panoramic radiographs
- 2022
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Ingår i: Oral surgery, oral medicine, oral pathology and oral radiology. - : Elsevier. - 2212-4403 .- 2212-4411. ; 133:1, s. 88-99
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To evaluate whether estimates of risk of future cardiovascular events and death and established or unknown diabetes are significantly associated with calcified carotid artery atheromas (CCAAs) on panoramic radiographs (PRs). The main focus was on men and women without previous myocardial infarction (MI). Methods: The PAROKRANK (Periodontitis and its Relation to Coronary Artery Disease) study included patients with a first MI and matched control subjects. In this substudy, 738 patients (138 women) and 744 control subjects (144 women) with available PRs were assessed for CCAA. Cardiovascular risk estimates were determined according to the Framingham Risk Score (FRS) and Systematic COronary Risk Evaluation (SCORE). Established and previously unknown diabetes was also determined. Results: CCAA was detected on PRs in 206 control subjects (28%) and 251 patients (34%). FRS was significantly associated with CCAA among control subjects (P = .04) and patients (P = .001). SCORE was associated with CCAA among control subjects (P < .01) but not patients (P = .07). Among men, FRS and SCORE were associated with CCAA in both control subjects and patients. Diabetes was not significantly associated with CCAA after adjustments. Conclusions: Elevated cardiovascular risk scores were associated with CCAA on PRs among control subjects. Diabetes was not independently associated with CCAA, possibly owing to selection bias.
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| 23. |
- Gustafsson, Nils, 1990-
(författare)
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Calcified carotid artery atheromas in panoramic radiographs : diagnostic reliability and association to cardiovascular disease, diabetes and periodontitis
- 2020
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Objective: Incidental findings of Calcified Carotid Artery Atheromas (CCAA) on Panoramic Radiographs (PRs) of the jaws can be a risk marker for cardiovascular disease. The objectives for the thesis were to investigate the association between CCAA and 1) Myocardial Infarction (MI), 2) periodontitis, 3) diabetes and 4) estimated cardiovascular risk. Also 5) if patients with both CCAA and periodontitis have a higher risk of MI. The final objective was to study 6) General Dental Practitioners (GDPs) ability to detect CCAA on PRs and if a short training programme can improve their diagnostic accuracy.Materials and methods: Paper I-III were part of the Swedish, multicentre (17 hospitals) case- control study Periodontitis and Its Relation to Coronary Artery Disease (PAROKRANK). The study included 1610 individuals, 805 cases (151 women) diagnosed with first acute MI, and 805 controls matched for age, sex and residential area. Seventeen participants were not examined with PR and an additional 111 were excluded due to inadequate quality. As a result, 90 participants lost their match. Paper I and II had a case-control design that only included matched cases (n = 696) and controls (n = 696). Paper II and III used a cross-sectional design to evaluate all included cases (n = 738) and controls (n = 744) separately. All participants in PAROKRANK went through a detailed medical and oral health examination, including e.g., oral glucose tolerance, an extensive blood panel, and 4-point pocket probing. All PRs were assessed both for the presence of CCAA and signs of poor oral health, including marginal bone loss. The results from the medical examination were used to estimate risk of future cardiovascular events and death using Systematic COronary Risk Evaluation (SCORE) and Framingham Risk Score (FRS). The results from the oral health examination were used to classify the degree of periodontitis both according to bone loss and clinical periodontal disease index (CPDI). Paper IV used a pre-post design to evaluate 14 GDPs diagnostic accuracy regarding assessment of CCAA on PR before and after participation in a short training programme. The GDPs were evaluated at baseline, 2 weeks and 1 year after training. Comparisons were made with the consensus of 2 experienced oral and maxillofacial radiologists.Results: Paper I: CCAA on PRs was more common among cases with recent first MI, (33.8% with CCAA), compared to controls (27.6%; P = 0.012). Paper II: CCAA and CPDI were associated among cases (OR 1.51; 95% CI, 1.09 to 2.10; P = 0.02) and controls (OR 1.70; 95% CI, 1.22 to 2.38; P < 0.01). No association was found between CCAA and the degree of bone loss on PR. MI had a stronger association to CCAA combined with periodontitis, than to either condition alone (OR 1.75; 95% CI, 1.11 to 2.74; P = 0.01). Paper III: Elevated risk of a future cardiovascular event estimated with FRS was associated with CCAA, both among cases (OR 1.89; 95% CI: 1.31–2.73, P = 0.001) and controls (OR 1.64; 95% CI: 1.03–2.64, P = 0.04). Elevated risk of cardiovascular death according to SCORE was associated with CCAA among controls (OR 1.58; 95% CI: 1.12–2.23, P < 0.01) but not among cases. Diabetes was more common among controls with than without CCAA (18.0% vs. 11.7%), but this association was not statistically significant after adjustments. Paper I-III included a sex- stratified analysis revealing that the results were mainly applicable on men. Paper IV: An improvement in diagnostic accuracy was observed among GDPs after a short training programme for diagnosing CCAA on PR. The sensitivity increased (41.8% to 55.7%, P = 0.02) without a decrease in specificity. The kappa values also increased (0.66 to 0.71, P = 0.04). At 1 year follow up, the improvements compared to baseline remained.Conclusions: There is an association between CCAA on PR and MI. Clinically diagnosed periodontitis is associated with CCAA on PR, and among participants with both periodontitis and CCAA there is a higher probability of having had MI than among participants with either condition alone. An increased estimated risk of future cardiovascular events and death according to FRS and SCORE is associated with CCAA on PR. These conclusions are mainly applicable on men. Diabetes was not independently associated with CCAA on PR, possibly due to selection bias. A short training programme can significantly and sustainably improve GDPs diagnostic accuracy regarding CCAA. This indicate that GDPs could contribute to prevention of cardiovascular events and death by detecting CCAA on PR and, should be encouraged to refer patients without previous treatment of cardiovascular disease for further medical attention, and if other cardiovascular risk factors are identified, necessary treatment.
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| 24. |
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| 25. |
- Hammar, Kimberley, et al.
(författare)
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Low Incidence of Late Ipsilateral Ischaemic Stroke After Treatment for Symptomatic Carotid Stenosis in Sweden 2008–2017 : Increased Risk in the Elderly and After Carotid Stenting
- 2022
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 63:1, s. 24-32
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Carotid stenosis is a major risk factor for stroke and surgical treatment is key in preventing recurrent ischaemic events. Previous randomised trials have demonstrated the net benefit of surgery for significant symptomatic carotid stenosis but, with present day medical treatment, there is limited evidence on the risk of late ipsilateral ischaemic stroke (IS) and its main risk factors.Method: Ipsilateral IS after the peri-operative period (≤ 30 days) was investigated in a nationwide, registry based cohort study of patients treated for symptomatic carotid stenosis in Sweden between 2008 – 2017. The Swedish National Registry for Vascular Surgery (Swedvasc) was used to establish the cohort, and the Swedish stroke registry (Riksstroke), combined with hospital records, was used to determine outcome. Stroke of any type and all cause mortality after the peri-operative period were studied as secondary outcomes. Cox regression was used to analyse associations between clinical factors and outcomes.Results: In total, 7 589 patients (mean age 72 ± 8 years, 68% men) were followed for 4.2 ± 2.6 years. Ipsilateral IS occurred in 232 patients corresponding to a yearly incidence of 0.73%. Age above 80 years compared with 65 – 79 years was associated with an increased risk of ipsilateral IS (adjusted HR 1.94, 95% CI 1.43 – 2.65). Carotid artery stenting (CAS) compared with carotid endarterectomy (CEA) was also associated with increased risk (adjusted HR 3.20, 95% CI 2.03 – 5.03). Stroke of any type occurred in 7.7% of patients, and 19.6% of patients died during the follow up period.Conclusion: The incidence of ipsilateral IS after treatment for symptomatic carotid stenosis in Sweden 2008–2017 was low, demonstrating the effectiveness and durability of surgery in a real world setting. Only age above 80 years and CAS compared with CEA were associated with increased risk of ipsilateral IS.
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