Publications by authors named "Stefan Olsson-Hau"

3 Publications

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RebiQoL: A randomized trial of telemedicine patient support program for health-related quality of life and adherence in people with MS treated with Rebif.

PLoS One 2019 5;14(7):e0218453. Epub 2019 Jul 5.

Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.

RebiQoL was a phase IV multicenter randomized study to assess the impact of a telemedicine patient support program (MSP) on health-related quality of life (HRQoL) in patients with relapsing-remitting MS (RRMS) being administered with Rebif with the RebiSmart device. The primary endpoint was to assess the impact of MSP compared to patients only receiving technical support for RebiSmart on HRQoL at 12 months, using the psychological part of Multiple Sclerosis Impact Scale (MSIS-29), in patients administered with Rebif. A total of 97 patients diagnosed with RRMS were screened for participation in the study of which 3 patients did not fulfill the eligibility criteria and 1 patient withdrew consent. Of the 93 randomized patients, 46 were randomized to MSP and 47 to Technical support only. The demographic characteristics of the patients were well-balanced in the two arms. There were no statistical differences (linear mixed model) in any of the primary (difference of 0.48, 95% CI: -8.30-9.25, p = 0.91) or secondary outcomes (p>0.05). Although the study was slightly underpowered, there was a trend towards better adherence in the MSP group (OR 3.5, 95% CI 0.85-14.40, p = 0.08) although not statistically significant. No unexpected adverse events occurred. This study did not show a statistically significant effect of the particular form of teleintervention used in this study on HRQoL as compared to pure technical support, for MS patients already receiving Rebif with the RebiSmart device. Trial Registration: ClinicalTrials.gov: NCT01791244.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0218453PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6611587PMC
February 2020

COOLIST (Cooling for Ischemic Stroke Trial): A Multicenter, Open, Randomized, Phase II, Clinical Trial.

Stroke 2017 01 17;48(1):219-221. Epub 2016 Nov 17.

From the Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus (M.G., L.J.K., H.B.v.d.W.) and Julius Center for Health Sciences and Primary Care (A.A.), University Medical Center Utrecht, The Netherlands; Department of Neurology, Skåne University Hospital, Malmö, Sweden (J.P., M.B., S.O.-H.); Department of Neurology, University Medical Center Groningen, The Netherlands (G.-J.L.); and Department of Neurology, Erasmus University Medical Center, Rotterdam, The Netherlands (D.W.J.D.).

Background And Purpose: Animal studies suggest that cooling improves outcome after ischemic stroke. We assessed the feasibility and safety of surface cooling to different target temperatures in awake patients with acute ischemic stroke.

Methods: A multicenter, randomized, open, phase II, clinical trial, comparing standard treatment with surface cooling to 34.0°C, 34.5°C, or 35.0°C in awake patients with acute ischemic stroke and an National Institutes of Health Stroke Scale score of ≥6, initiated within 4.5 hours after symptom onset and maintained for 24 hours. The primary outcome was feasibility, defined as the proportion of patients who had successfully completed the assigned treatment. Safety was a secondary outcome.

Results: Inclusion was terminated after 22 patients because of slow recruitment. Five patients were randomized to 34.0°C, 6 to 34.5°C, 5 to 35.0°C (cooling was initiated in 4), and 6 to standard care. No (0%), 1 (17%), and 3 (75%) patients, respectively, completed the assigned treatment (P=0.03). No (0%), 2 (33%), and 4 (100%) patients reached the target temperature (P=0.01). Pneumonia occurred in 8 cooled patients but not in controls (absolute risk increase, 53%; 95% confidence interval, 28-79%; P=0.002).

Conclusions: In awake patients with acute ischemic stroke, surface cooling is feasible to 35.0°C, but not to 34.5°C and 34.0°C. Cooling is associated with an increased risk of pneumonia.

Clinical Trial Registration: URL: http://www.trialregister.nl. Unique identifier: NTR2616.
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http://dx.doi.org/10.1161/STROKEAHA.116.014757DOI Listing
January 2017