| 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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