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"Wester, Per"
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Oral neuromuscular training in patients with dysphagia after stroke: a prospective, randomized, open-label study with blinded evaluators
2020
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.
Journal Article
Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel
2019
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.
Trial registration
The protocol for this study was registered at the Northern Ireland Hub for trials methodology research (SWAT ID
64
). The EFFECTS study has EudraCT number 2011–006130-16 and was registered 17 February 2016 at ClinicalTrials.gov number
NCT02683213
.
Journal Article
Swallowing dysfunction as risk factor for undernutrition in older people admitted to Swedish short-term care: a cross-sectional study
by
Hägglund, Patricia
,
Hägg, Mary
,
Fält, Anna
in
Aspiration
,
Caring Sciences
,
Cross-sectional studies
2019
Background
Swallowing dysfunction and risk of undernutrition increase the risk of pneumonia, morbidity, and mortality. Short-term care is an unexplored care context, where many older people stay yearly.
Aim
This cross-sectional study aimed to describe and analyze the relationship between swallowing dysfunction and risk of undernutrition among older people in short-term care, including potential gender-related differences.
Methods
In total, 391 people (209 women), aged ≥ 65 years (median age 84 years) and admitted to short-term care in five Swedish counties participated. They went through a timed water swallow test to assess swallowing dysfunction, including abnormal swallowing capacity and signs of aspiration (i.e., cough and voice change). Risk for undernutrition was assessed using the Minimal Eating Observation and Nutrition Form-version II.
Results
Swallowing dysfunction was observed in 248 of 385 (63%) participants, including abnormal swallowing capacity in 213 of 385 (55%) and aspiration signs in 127 of 377 (34%). Abnormal swallowing capacity was more frequent among women (
p
= 0.030), whereas men with normal swallowing capacity exhibited signs of aspiration more frequently (cough
p
= 0.038, voice change
p
= 0.004). Risk of undernutrition was found in 91 of 390 (23%) participants, more frequently among women (
p
= 0.007). A logistic regression model revealed an increased risk of undernutrition among older people with abnormal swallowing capacity (OR 1.74, 95% CI 1.04–2.92,
p
= 0.034).
Conclusions
The high prevalence of swallowing dysfunction and risk of undernutrition highlight the need for a systematic screening program and feasible treatment to improve swallowing function for adequate and safe food intake among older people in short-term care.
Clinical trial registration
This study was registered with ClinicalTrials.gov on July 4, 2016, under NCT02825927.
Journal Article
Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): a stepped wedge cluster randomised trial within the EFFECTS trial
2025
Two out of three randomised controlled trials (RCTs) fail to meet their recruitment goals. Recruitment to Efficacy oF Fluoxetine - a randomisEd Controlled Trial in Stroke (EFFECTS), fluoxetine for stroke recovery was slower than anticipated. We aimed to evaluate an intervention to improve recruitment to EFFECTS.
This stepped wedge, cluster randomised study investigated whether a teleconference with the study personnel and the head of department could enhance recruitment in the ongoing EFFECTS. We included 20 low- and medium recruiting active centres. We excluded high recruiting centres. All centres started as controls and were followed by 60 days of observation. We used block randomisation. The primary outcome was a 20% increase of recruitment within 60 days post intervention compared within 60 days pre intervention. Secondary outcomes were comparing recruitment between different types of centres, that is small versus large or experienced versus non-experienced centres, and university versus non-university hospitals. In exploratory analyses, recruitment within 30 days post versus 30 days pre intervention was compared.
The recruitment increased by 10% at 60 days. We noticed a short-lived increase of 23% the first month. The increased recruitment was most pronounced in low-recruiting, small and non-university hospitals. The recruitment of patients increased after the first contact with the centres where we announced that there would be a conference.
A teleconference with the study personnel and the head of department increased the recruitment by 23% within 30 days and by 10%, 60 days post intervention in this embedded RCT. This implies that this structured intervention aimed at increased recruitment was short-lived and would need frequent repetitions in order to be effective.
Journal Article
Large variations in atrial fibrillation screening practice after ischemic stroke and transient ischemic attack in Sweden: a survey study
by
Rooth, Elisabeth
,
Strååt, Kajsa
,
Isaksson, Eva
in
Analysis
,
Atrial fibrillation
,
Cardiac arrhythmia
2024
Background
Atrial fibrillation (AF) screening after ischemic stroke or transient ischemic attack (TIA) is given high priority in clinical guidelines. However, patient selection, electrocardiogram (ECG) modality and screening duration remains undecided and current recommendations vary.
Methods
The aim of this study was to investigate the clinical practice of AF screening after ischemic stroke or TIA at Swedish stroke units. In collaboration with the stakeholders of
the Swedish Stroke Register
(Riksstroke) a digital survey was drafted, then tested and revised by three stroke consultants. The survey consisted of 17 multiple choice/ free text questions and was sent by e-mail to the medical directors at all stroke units in Sweden.
Results
All 72 stroke units in Sweden responded to the survey. Most stroke units reported that ≥ 75% of ischemic stroke (69/72 stroke units) or TIA patients (67/72 stroke units), without previously known AF, were screened for AF. Inpatient telemetry ECG was the method of first-choice in 81% of the units, but 7% reported lack of access. A variety of standard monitoring durations were used for inpatient telemetry ECG. The second most common choice was Holter ECG (17%), also with considerable variations in monitoring duration. Other AF screening modalities were used as a first-choice method (handheld and patch ECG) but less frequently.
Conclusions
Clinical practice for AF screening after ischemic stroke or TIA differed between Swedish stroke units, both in choice of AF screening methods as well as in monitoring durations. There is an urgent need for evidence and evidence-based recommendations in this field.
Trial registration
Not applicable.
Journal Article
The psychosocial work environment is associated with risk of stroke at working age
by
Jood, Katarina
,
Karlsson, Nadine
,
Medin, Jennie
in
Arbetsmedicin och miljömedicin
,
case control study
,
Case-Control Studies
2017
Objective The aim of this study was to explore the relation between the risk of first-ever stroke at working age and psychological work environmental factors. Methods A consecutive multicenter matched 1:2 case–control study of acute stroke cases (N=198, age 30–65 years) who had been working full-time at the time of their stroke and 396 sex- and age-matched controls. Stroke cases and controls answered questionnaires on their psychosocial situation during the previous 12 months. The psychosocial work environment was assessed using three different measures: the job–control–demand model, the effort–reward imbalance (ERI) score, and exposures to conflict at work. Results Among 198 stroke cases and 396 controls, job strain [odds ratio (OR) 1.30, 95% confidence interval (95% CI) 1.05–1.62], ERI (OR 1.28, 95% CI 1.01–1.62), and conflict at work (OR 1.75, 95% CI 1.07–2.88) were independent risk factors of stroke in multivariable regression models. Conclusions Adverse psychosocial working conditions during the past 12 months were more frequently observed among stroke cases. Since these factors are presumably modifiable, interventional studies targeting job strain and emotional work environment are warranted.
Journal Article
Ultrasound Assessment of Carotid Plaque Echogenicity Response to Statin Therapy: A Systematic Review and Meta-Analysis
by
Bajraktari, Gani
,
Ibrahimi, Pranvera
,
Henein, Michael
in
Carotid Stenosis - complications
,
Carotid Stenosis - diagnostic imaging
,
Carotid Stenosis - drug therapy
2015
Objective: To evaluate in a systematic review and meta-analysis model the effect of statin therapy on carotid plaque echogenicity assessed by ultrasound. Methods: We have systematically searched electronic databases (PubMed, MEDLINE, EMBASE and Cochrane Center Register) up to April, 2015, for studies evaluating the effect of statins on plaque echogenicity. Two researchers independently determined the eligibility of studies evaluating the effect of statin therapy on carotid plaque echogenicity that used ultrasound and grey scale median (GSM) or integrated back scatter (IBS). Results: Nine out of 580 identified studies including 566 patients’ carotid artery data were meta-analyzed for a mean follow up of 7.2 months. A consistent increase in the echogenicity of carotid artery plaques, after statin therapy, was reported. Pooled weighted mean difference % (WMD) on plaque echogenicity after statin therapy was 29% (95% CI 22%–36%), p < 0.001, I2 = 92.1%. In a meta-regression analysis using % mean changes of LDL, HDL and hsCRP as moderators, it was shown that the effects of statins on plaque echogenicity were related to changes in hsCRP, but not to LDL and HDL changes from the baseline. The effect of statins on the plaque was progressive; it showed significance after the first month of treatment, and the echogenicity continued to increase in the following six and 12 months. Conclusions: Statin therapy is associated with a favorable increase of carotid plaque echogenicity. This effect seems to be dependent on the period of treatment and hsCRP change from the baseline, independent of changes in LDL and HDL.
Journal Article
Effect of early supported discharge after stroke on patient reported outcome based on the Swedish Riksstroke registry
by
Bråndal, Anna
,
Glader, Eva-Lotta
,
Eriksson, Marie
in
Activities of daily living
,
Analysis
,
Cardiac rehabilitation
2019
Background
The efficacy of early supported discharge (ESD) has not been tested in current stroke care setting, which provide relatively short hospital stays, access to hyper-acute therapies and early carotid stenosis interventions. This study aimed to compare patient-reported outcome measures (PROM) among patients with stroke that received modern stroke unit care with or without ESD.
Methods
Observational study of 30,232 patients with first-ever stroke registered in the Riksstroke registry in Sweden, between 1 January 2010 and 31 December 2013. Patient characteristics were collected from the Riksstroke and Statistics Sweden databases. The primary outcome was satisfaction with the rehabilitation at 3 months after discharge. Secondary outcome were information about stroke provided, tiredness/fatigue, pain, dysthymia/depression, general health status and dependence in activities of daily living (mobility, toileting and dressing) at 3 months after the stroke. We used separate multivariable logistic regression models for each PROM variable to analyze associations between PROMs and ESD/no ESD.
Results
The ESD group comprised 1495 participants: the control group comprised 28,737 participants. Multivariable logistic regression models of PROMs showed that, compared to controls, the ESD group was more satisfied with rehabilitation after discharge (OR: 1.78, 95% CI: 1.17–2.49), experienced less dysthymia/depression (OR: 0.68, 95% 0.55–0.84) and showed more independence in mobility (OR: 1.50, 95% CI: 1.17–1.92), toileting (OR: 1.30, 95%CI: 1.05–1.61), and dressing (OR: 1.23, 95%CI: 1.02–1.48).
Conclusion
In the setting of modern stroke unit care, ESD appeared to have positive effects on stroke rehabilitation, in the subacute phase.
Journal Article
Atrial fibrillation among patients under investigation for suspected obstructive sleep apnea
2017
Obstructive sleep apnea is common among patients with atrial fibrillation, but the prevalence and risk factors for atrial fibrillation among patients who are being investigated on suspicion of sleep apnea are not well known. The aim of the study was to estimate the prevalence of atrial fibrillation among patients investigated for suspected obstructive sleep apnea and to identify risk factors for atrial fibrillation among them.
The prevalence of atrial fibrillation was investigated among 201 patients referred for suspected obstructive sleep apnea. Patients without known atrial fibrillation were investigated with a standard 12-lead ECG at hospital and short intermittent handheld ECG recordings at home, during 14 days.
Atrial fibrillation occurred in 13 of 201 subjects (6.5%), and in 12 of 61 men aged 60 years and older (20%). The prevalence of atrial fibrillation increased with sleep apnea severity (p = 0.038). All patients with atrial fibrillation were men and all had sleep apnea. Age 60 or older, the occurrence of central sleep apnea and diabetes mellitus were independent risk factors for atrial fibrillation after adjustments for body mass index, gender, sleep apnea and cardiovascular disease.
Atrial fibrillation is common among subjects referred for sleep apnea investigation and the prevalence of atrial fibrillation increases with sleep apnea severity. Independent risk factors for atrial fibrillation among patients investigated for suspected obstructive sleep apnea include the occurrence of coexisting central sleep apnea, age 60 years or older and diabetes mellitus.
Journal Article
Ultrasound risk marker variability in symptomatic carotid plaque: impact on risk reclassification and association with temporal variation pattern
by
Johansson, Elias
,
Sjödin Elias
,
Grönlund Christer
in
Arteriosclerosis
,
Atherosclerosis
,
Coarseness
2020
PurposeUltrasound 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.Methods56 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).ResultsInter-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.ConclusionsRisk 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.
Journal Article