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- Lundström, E, 1964-, et al.
(författare)
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Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC) : study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial
- 2018
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Ingår i: Trials. - : BIOMED CENTRAL LTD. - 1745-6215. ; 19
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Tidskriftsartikel (refereegranskat)abstract
- Background: Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT. Methods: ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n=27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT. Discussion: EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the future. It might also be useful in clinical settings outside the field of stroke.
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| 2. |
- Gustafsson, Joakim Körner, et al.
(författare)
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Voice use in daily life studied with a portable voice accumulator in individuals with Parkinson’s disease and matched healthy controls
- 2019
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Ingår i: Journal of Speech, Language and Hearing Research. - 1092-4388 .- 1558-9102. ; 62:12, s. 4324-4334
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: The purpose of this work was to study how voice use in daily life is impacted by Parkinson’s disease (PD), specifically if there is a difference in voice sound level and phonation ratio during everyday activities for individuals with PD and matched healthy controls. A further aim was to study how variations in environmental noise impact voice use. Method: Long-term registration of voice use during 1 week in daily life was performed for 21 participants with PD (11 male, 10 female) and 21 matched healthy controls using the portable voice accumulator VoxLog. Voice use was assessed through registrations of spontaneous speech in different ranges of environmental noise in daily life and in a controlled studio recording setting. Results: Individuals with PD use their voice 50%-60% less than their matched healthy controls in daily life. The difference increases in high levels of environmental noise. Individuals with PD used an average voice sound level in daily life that was 8.11 dB (female) and 6.7 dB (male) lower than their matched healthy controls. Difference in mean voice sound level for individuals with PD and controls during spontaneous speech during a controlled studio registration was 3.0 dB for the female group and 4.1 dB for the male group. Conclusions: The observed difference in voice use in daily life between individuals with PD and matched healthy controls is a 1st step to objectively quantify the impact of PD on communicative participation. The variations in voice use in different levels of environmental noise and when comparing controlled and variable environments support the idea that the study of voice use should include methods to assess function in less controlled situations outside the clinical setting.
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| 3. |
- Gustafsson, J., et al.
(författare)
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Motor-Learning-Based Adjustment of Ambulatory Feedback on Vocal Loudness for Patients With Parkinson's Disease
- 2016
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Ingår i: Journal of Voice. - : Elsevier. - 0892-1997 .- 1873-4588. ; 30:4, s. 407-415
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: To investigate how the direct biofeedback on vocal loudness administered with a portable voice accumulator (VoxLog) should be configured, to facilitate an optimal learning outcome for individuals with Parkinson's disease (PD), on the basis of principles of motor learning. Study Design: Methodologic development in an experimental study. Methods: The portable voice accumulator VoxLog was worn by 20 participants with PD during habitual speech during semistructured conversations. Six different biofeedback configurations were used, in random order, to study which configuration resulted in a feedback frequency closest to 20% as recommended on the basis of previous studies. Results: Activation of feedback when the wearer speaks below a threshold level of 3dB below the speaker's mean voice sound level in habitual speech combined with an activation time of 500ms resulted in a mean feedback frequency of 21.2%. Conclusions: Settings regarding threshold and activation time based on the results from this study are recommended to achieve an optimal learning outcome when administering biofeedback on vocal loudness for individuals with PD using portable voice accumulators.
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| 4. |
- Blystad, Ida, et al.
(författare)
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Quantitative MRI for Analysis of Active Multiple Sclerosis Lesions without Gadolinium-Based Contrast Agent
- 2016
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Ingår i: American Journal of Neuroradiology. - : American Society of Neuroradiology (ASNR). - 0195-6108 .- 1936-959X. ; 37:1, s. 94-100
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND PURPOSE: Contrast-enhancing MS lesions are important markers of active inflammation in the diagnostic work-up of MS and in disease monitoring with MR imaging. Because intravenous contrast agents involve an expense and a potential risk of adverse events, it would be desirable to identify active lesions without using a contrast agent. The purpose of this study was to evaluate whether pre-contrast injection tissue-relaxation rates and proton density of MS lesions, by using a new quantitative MR imaging sequence, can identify active lesions.MATERIALS AND METHODS: Forty-four patients with a clinical suspicion of MS were studied. MR imaging with a standard clinical MS protocol and a quantitative MR imaging sequence was performed at inclusion (baseline) and after 1 year. ROIs were placed in MS lesions, classified as nonenhancing or enhancing. Longitudinal and transverse relaxation rates, as well as proton density were obtained from the quantitative MR imaging sequence. Statistical analyses of ROI values were performed by using a mixed linear model, logistic regression, and receiver operating characteristic analysis.RESULTS: Enhancing lesions had a significantly (P < .001) higher mean longitudinal relaxation rate (1.22 ± 0.36 versus 0.89 ± 0.24), a higher mean transverse relaxation rate (9.8 ± 2.6 versus 7.4 ± 1.9), and a lower mean proton density (77 ± 11.2 versus 90 ± 8.4) than nonenhancing lesions. An area under the receiver operating characteristic curve value of 0.832 was obtained.CONCLUSIONS: Contrast-enhancing MS lesions often have proton density and relaxation times that differ from those in nonenhancing lesions, with lower proton density and shorter relaxation times in enhancing lesions compared with nonenhancing lesions.
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| 6. |
- Körner Gustafsson, Joakim, et al.
(författare)
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Treatment of Hypophonia in Parkinson’s Disease Through Biofeedback in Daily Life Administered with A Portable Voice Accumulator
- 2021
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Ingår i: Journal of Voice. - : Elsevier. - 0892-1997 .- 1873-4588.
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Tidskriftsartikel (refereegranskat)abstract
- ObjectivesThe purpose of this study was to assess the outcome following continuous tactile biofeedback of voice sound level administered, with a portable voice accumulator to individuals with Parkinson's disease (PD).MethodNine out of 16 participants with PD completed a 4-week intervention program where biofeedback of voice sound level was administered with the portable voice accumulator VoxLog during speech in daily life. The feedback, a tactile vibration signal from the device, was activated when the wearer used a voice sound level below an individually predetermined threshold level, reminding the wearer to increase voice sound level during speech. Voice use was registered in daily life with the VoxLog during the intervention period as well as during one baseline week, one follow-up week post intervention and 1 week 3 months post intervention. Self-to-other ratio (SOR), which is the difference between voice sound level and environmental noise, was studied in multiple noise ranges.ResultsA significant increase in SOR across all noise ranges of 2.28 dB (SD: 0.55) was seen for participants with scores above the cut-off for normal function (>26 points) on the cognitive screening test Montreal Cognitive Assessment (MoCA) (n = 5). No significant increase was seen for the group of participants with MoCA scores below 26 (n = 4). Forty-four percent ended their participation early, all which scored below 26 on MoCA (n = 7).ConclusionsBiofeedback administered in daily life regarding voice level may help individuals with PD to increase their voice sound level in relation to environmental noise in daily life, but only for a limited subset. Only participants with normal cognitive function as screened by MoCA improved their voice sound level in relation to environmental noise.
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| 7. |
- Mead, Gillian Elizabeth, et al.
(författare)
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Update to the FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke : statistical analysis plan for the trials and for the individual patient data meta-analysis
- 2020
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Ingår i: Trials. - : Springer Nature. - 1745-6215. ; 21:1
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundThree large trials of fluoxetine for stroke recovery (FOCUS (fluoxetine or control under supervision), AFFINITY (the Assessment oF FluoxetINe In sTroke recovery) and EFFECTS (Efficacy oF Fluoxetine-a randomisEd Controlled Trial in Stroke)) have been collaboratively designed with the same basic protocol to facilitate an individual patient data analysis (IPDM). The statistical analysis plan for the three individual trials has already been reported in Trials, including a brief description of the IPDM. In this protocol, we describe in detail how we will perform the IPDM.Methods/designData from EFFECTS and AFFINITY will be transferred securely to the FOCUS statistician, who will perform a one-stage IPDM and a two-stage IPDM. For the one-stage IPDM, data will be combined into a single data set and the same analyses performed as described for the individual trials. For the two-stage IPDM, the results for the three individual trials will be combined using fixed effects meta-analyses.The primary and secondary outcome domains for the IPDM are the same as for individual trials. We will also perform analyses according to several subgroups including country of recruitment, ethnicity and trial. We will also explore the effects of fluoxetine on our primary and secondary outcomes in subgroups defined by combinations of characteristics.We also describe additional research questions that will be addressed using the combined data set, and published subsequently, including predictors of important post-stroke problems such as seizures, low mood and bone fractures.DiscussionAn IPDM of our three large trials of fluoxetine for stroke recovery will allow us to provide the most precise estimates of any risks and benefits of fluoxetine vs placebo, to detect reliably a smaller overall effect size than those detectable by the individual trials, to better determine the effects of fluoxetine vs placebo in subgroups of patients and outcomes and to broaden the generalisability of the results. Also, we may identify differences in treatment effects between studies.Trial registrationFOCUS: ISRCTN ISRCTN83290762. Registered on 23 May 2012. EudraCT 2011-005616-29. Registered on 3 February 2012.AFFINITY: Australian New Zealand Clinical Trials Registry ACTRN12611000774921. Registered on 22 July 2011.EFFECTS: ISRCTN ISRCTN13020412. Registered on 19 December 2014. ClinicalTrials.gov NCT02683213. Registered on 2 February 2016. EudraCT 2011-006130-16. Registered on 8 August 2014.
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| 8. |
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| 9. |
- 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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| 10. |
- Löfhed, Johan, et al.
(författare)
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Soft textile electrodes for EEG monitoring
- 2010
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Konferensbidrag (refereegranskat)abstract
- There is a need for long term monitoring of the brain during intensive care. This is e.g. the case for newborn babies that have been exposed to hypoxia during delivery. Electroencephalography (EEG) is the technique of choice. To get a clear and detailed view of the brain activity a large number of EEG electrodes should be used. Applying traditional electrodes one by one is a time-consuming and technically demanding work and therefore electrode caps are sometimes used. The existing caps have however been found to be suboptimal for long term monitoring because they may induce too high a pressure on the scalp of the babies. We have tested three different types of textile electrodes with regard to their potential use for EEG monitoring. The results show that soft conducting textile materials can indeed be used for EEG monitoring.
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