| 1. |
- 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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| 2. |
- 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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| 3. |
- 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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| 4. |
- 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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| 5. |
- Hägglund, Patricia, et al.
(författare)
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Oral neuromuscular training in patients with dysphagia after stroke : a prospective, randomized, open-label study with blinded evaluators
- 2020
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Ingår i: BMC Neurology. - : Springer Nature. - 1471-2377. ; 20
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Tidskriftsartikel (refereegranskat)abstract
- Background: Oral and pharyngeal swallowing dysfunction are common complications in acute stroke patients. This primary aim of this study was to determine whether oral neuromuscular training improves swallowing function in participants with swallowing dysfunction after stroke. A secondary aim was to assess how well results of the timed water-swallow test (TWST) correspond with swallowing dysfunction diagnosed by videofluoroscopy (VFS).Methods: This was an intention-to-treat two-centre prospective randomized open-label study with blinded-evaluators (PROBE) design. At 4 weeks after stroke onset, participants with swallowing dysfunction were randomized to 5 weeks of continued orofacial sensory-vibration stimulation with an electric toothbrush or additional oral neuromuscular training with an oral device (Muppy®). Participants were examined with TWST, a lip-force test, and VFS before (baseline), after 5 weeks’ treatment (the end-of-treatment), and 12 months after treatment (follow-up). The baseline VFS results were compared with the TWST results. The primary endpoint was changes in swallowing rate assessed using TWST, from baseline to the end of training and from baseline to follow-up based on intention-to-treat analyses. The secondary endpoint was the corresponding changes in lip-force between baseline, the end of treatment, and follow-up.Results: The participants were randomly assigned as controls (n = 20) or for intervention with oral neuromuscular training (n = 20). After treatment, both groups had improved significantly (intervention, P < 0.001; controls, P = 0.001) in TWST but there was no significant between-group difference in swallowing rate. At the 12-month follow-up, the intervention group had improved further whereas the controls had deteriorated, and there were significant between-group differences in swallowing rate (P = 0.032) and lip force (P = 0.001). A TWST < 10 mL/sec at baseline corresponded to VFS-verified swallowing dysfunction in all assessed participants.Conclusion: The 5-week oral neuromuscular training improved swallowing function in participants with post-stroke dysphagia compared with the controls 12 months after intervention, but there was no between-group difference in improvement immediately after treatment. TWST results corresponded with VFS results, making TWST a feasible method for identifying persons with swallowing dysfunction after stroke. Larger randomized controlled trials are required to confirm our preliminary positive long-term results.Trial registration: Retrospectively registered at ClinicalTrials.gov: NCT04164420. Registered on 15 November 2019.
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| 6. |
- Larsen, Kristin Tveitan, et al.
(författare)
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STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage : Protocol for a randomised controlled trial
- 2020
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Ingår i: European Stroke Journal. - : Sage Publications. - 2396-9873 .- 2396-9881. ; 5:4, s. 414-422
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 7. |
- Stenudd, Isak, et al.
(författare)
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Ultrasound risk marker variability in symptomatic carotid plaque : impact on risk reclassification and association with temporal variation pattern
- 2020
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Ingår i: The International Journal of Cardiovascular Imaging. - : Springer. - 1569-5794 .- 1875-8312 .- 1573-0743. ; 36:6, s. 1061-1068
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: Ultrasound examinations of atherosclerotic carotid plaques can be used to calculate risk markers associated with plaque vulnerability. Recent studies demonstrate significant inter-frame variability in risk markers. Here, we investigate risk marker variability in symptomatic plaques and its impact on reclassification of plaque vulnerability, as well as its association with the shape of the temporal variation over the cardiac cycle.Methods: 56 patients with symptomatic carotid stenosis were included in this study. 88 plaques were identified and the plaque risk markers size (area), echogenicity (gray scale median, GSM) and heterogeneity (coarseness) were measured in all frames of ultrasound B-mode image sequences. Inter-frame variability was quantified using the coefficient of variation (CV).Results: Inter-frame variabilities of the risk markers were area CV 5–8%; GSM CV 4–7%; coarseness CV 8–15% and was in general significantly lower in large as compared to smaller plaques. The variability in GSM risk marker caused a reclassification of vulnerability in 30 to 38% of the plaques. Temporal variations in GSM with a heart rate periodic or drift/trending pattern were found in smaller plaques (< 26 mm2), whereas random pattern was found in larger plaques. In addition, hypoechoic plaques (GSM < 25) were associated with cyclic variation pattern, independent of their size.Conclusions: Risk marker variability causes substantial reclassification of plaque vulnerability in symptomatic patients. Inter-frame variation and its temporal pattern should be considered in the design of future studies related to risk markers.
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