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- Blom Johansson, Monica, 1965-
(författare)
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Aphasia and Communication in Everyday Life : Experiences of persons with aphasia, significant others, and speech-language pathologists
- 2012
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The aims of this thesis were to describe the experiences of persons with aphasia and their significant others of their conversations and use of communication strategies, examine current practice of family-oriented speech-language pathology (SLP) services, and test a family-oriented intervention in the early phase of rehabilitation.The persons with aphasia valued having conversations despite perceiving their aphasia as a serious social disability. They acknowledged the importance of the communication partners’ knowledge and understanding of aphasia and their use of supporting conversation strategies. Their own use of communication strategies varied considerably. The persons with aphasia longed to regain language ability and to be active participants in society.A majority of the significant others perceived their conversations with the person with aphasia as being less stimulating and enjoyable than conversations before stroke onset. Aphasia was considered a serious problem. The significant others took on increased communicative responsibility, where two thirds had changed their communicative behaviour to facilitate conversations. Type and severity of aphasia were especially related to the communicative experiences of the significant others and their motivation to be involved in SLP services.Thirty percent of the speech-language pathologists worked with people with aphasia and typically met with their families. They considered the involvement of significant others in SLP services as very important, especially in providing information about aphasia and communication partner training (CPT). However, involvement of significant others was restricted because of a time shortage and perceived limited skills and knowledge. In addition, there were national differences regarding aphasia rehabilitation services.The intervention consisted of three sessions directed to significant others (primarily emotional support and information) and three directed to the dyads (a person with aphasia and a significant other) (primarily CPT). All six participants (three dyads) felt that their knowledge and understanding of aphasia had increased and that their conversations had improved. These improvements were also evident to some extent with formal assessments.These results suggest the following: CPT should be an integral part of SLP services, national clinical guidelines are needed, and further education of speech-language pathologists and implementation of new knowledge into clinical practice requires consideration.
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| 2. |
- Hägglund, Patricia, 1989-
(författare)
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Swallowing dysfunction among older people in short-term care : prevalence, effect of intervention, and risk of mortality
- 2019
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Objectives: Swallowing dysfunction (dysphagia) is a common, but often neglected condition among geriatric patients that can cause severe complications such as malnutrition, aspiration pneumonia and death. The aims of this thesis were to (i) describe the study design and method of the multidisciplinary and multicenter project SOFIA (Swallowing function, Oral health, and Food Intake in old Age), (ii) study the prevalence of and the relationship between swallowing dysfunction and risk of undernutrition among older individuals in short-term care, (iii) study the effect of oral neuromuscular training on swallowing dysfunction among older individuals, and (iv) to investigate the association between poor oral health, swallowing dysfunction and mortality.Methods: This thesis includes four original papers that are all part of the SOFIA project. Paper Iis the study protocol. In total, 391 individuals aged 65 or older, from 36 short-term care units were included in the project. At baseline the participants’ status regarding swallowing function (assessed with the Timed Water Swallow Test, TWST), oral health (using the Revised Oral Assessment Guide, ROAG) and nutrition (assessed with the Minimal Eating Observation and Nutrition Form-version II, MEONF-II) were assessed and collected by calibrated professionals. Clinical data were also collected. Paper IIwas a cross-sectional study where the baseline assessments of the participants’ swallowing function and nutritional status were obtained and the relationship analyzed. Paper IIIwas a cluster randomized, controlled trial (cRCT) that included 116 participants identified with swallowing dysfunction in paper II. These participants were randomly assigned to either usual care (control group) or oral neuromuscular training (intervention group). All participants were assessed at baseline, after five weeks’ training and six months after end-of-treatment, regarding swallowing function and swallowing-related quality of life (QOL). Paper IVwas a prospective cohort study where all participants were followed-up 1-year after inclusion to investigate risk factors for mortality by analysis of the associations between swallowing dysfunction, poor oral health, and 1-year survival. Results: Paper II:The median age of the 391 participants was 84 years (Interquartile range [IQR] 11) and 209 (53%) were females. In total, 248 of the 385 (64%) participants showed swallowing dysfunction, and risk of undernutrition was observed in 91 of 390 (23%) participants. The adjusted logistics regression model revealed that participants with swallowing dysfunction had significantly higher odds of undernutrition than those with normal swallowing (Odds ratio [OR]: 1.74, 95% Confidence interval [CI] 1.04 to 2.92, P=0.034).Paper III: At end-of-treatment, a linear mixed model showed significant between-group differences of changes in swallowing efficacy between baseline and after completed treatment period (Ratio 1.60, 95% CI 1.15 to 2.29, P=0.007); indicating a 60% higher swallowing efficacy in the intervention group compared with the control group. Paper IV: A mixed effects Cox model showed that swallowing dysfunction and poor oral health were both independently associated with 1-year mortality (adjusted Hazard Ratio [aHR]: 1.67, 95% CI 1.02 to 2.75,P=0.041 and aHR: 1.98, 95% CI 1.07 to 3.65, P=0.029, respectively). In addition, swallowing dysfunction and poor oral health in combination predicted the highest mortality rate (35%, P<0.001).Conclusion: Swallowing dysfunction is highly prevalent and a risk factor for undernutrition among older people in short-term care. Oral neuromuscular training improves swallowing dysfunction and is thus a promising method of swallowing rehabilitation for older people with impaired swallowing. Swallowing dysfunction and poor oral health are independent risk factors for 1-year morality among older people in short-term care. Therefore, systematic screening and intervention to improve swallowing dysfunction and poor oral health are important to achieve healthy aging and to prevent undernutrition and early death.
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| 3. |
- 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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| 4. |
- 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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| 6. |
- 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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| 7. |
- 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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| 8. |
- Lundström, Erik, 1964-, et al.
(författare)
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Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial.
- 2020
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Ingår i: The Lancet. Neurology. - 1474-4465 .- 1474-4422. ; 19:8, s. 661-669
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Tidskriftsartikel (refereegranskat)abstract
- Studies have suggested that fluoxetine could improve neurological recovery after stroke. The Efficacy oF Fluoxetine-a randomisEd Controlled Trial in Stroke (EFFECTS) trial aimed to assess whether administration of oral fluoxetine for 6 months after acute stroke improves functional outcome.EFFECTS was an investigator-led, multicentre, randomised, placebo-controlled, double-blind, parallel group trial that enrolled patients aged 18 years or older between 2 and 15 days after stroke onset in 35 stroke and rehabilitation centres in Sweden. Eligible patients had a clinical diagnosis of ischaemic or intracerebral haemorrhage, brain imaging that was consistent with intracerebral haemorrhage or ischaemic stroke, and had at least one persisting focal neurological deficit. A web-based randomisation system that incorporated a minimisation algorithm was used to randomly assign (1:1) participants to receive oral fluoxetine 20 mg once daily or matching placebo capsules for 6 months. Patients, care providers, investigators, and outcomes assessors were masked to the allocation. The primary outcome was functional status, measured with the modified Rankin Scale (mRS) at 6 months, analysed in all patients with available mRS data at the 6-month follow-up; we did an ordinal analysis adjusted for the minimisation variables used in the randomisation. This trial is registered with EudraCT, 2011-006130-16; ISRCTN, 13020412; and ClinicalTrials.gov, NCT02683213.Between Oct 20, 2014, and June 28, 2019, 1500 patients were enrolled, of whom 750 were randomly assigned to fluoxetine and 750 were randomly assigned to placebo. At 6 months, mRS data were available for 737 (98%) patients in the fluoxetine group and 742 (99%) patients in the placebo group. There was no effect of fluoxetine on the primary outcome-distribution across mRS score categories-compared with placebo (adjusted common odds ratio 0·94 [95% CI 0·78 to 1·13]; p=0·42). The proportion of patients with a new diagnosis of depression was lower with fluoxetine than with placebo (54 [7%] patients vs 81 [11%] patients; difference -3·60% [-6·49 to -0·71]; p=0·015), but fluoxetine was associated with more bone fractures (28 [4%] vs 11 [2%]; difference 2·27% [0·66 to 3·87]; p=0·0058) and hyponatraemia (11 [1%] vs one [<1%]; difference 1·33% [0·43 to 2·23]; p=0·0038) at 6 months.Functional outcome after acute stroke did not improve with oral fluoxetine 20 mg once daily for 6 months. Fluoxetine reduced the occurrence of depression but increased the risk of bone fractures and hyponatraemia. Our results do not support the use of fluoxetine after acute stroke.The Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Brain Foundation, the Swedish Society of Medicine, King Gustav V and Queen Victoria's Foundation of Freemasons, and the Swedish Stroke Association (STROKE-Riksförbundet).
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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. |
- Norrving, Bo, et al.
(författare)
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Beyond conventional stroke guidelines: setting priorities
- 2007
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Ingår i: Stroke. - 1524-4628 .- 0039-2499. ; 38:7, s. 2185-2190
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND PURPOSE: Priorities in the care of stroke patients are often intuitive. An open and translucent priority-setting procedure would benefit patients, professionals, and decision-makers. Prioritization is an innovative part of the new Swedish national stroke guidelines. METHODS: Working groups identified diagnostic procedures, interventions and therapies in stroke care, assessed each one according to severity (needs), effect of action, level of scientific evidence and cost-effectiveness. The items were then ranked into priority groups from 1 (highest) to 10 (lowest). Procedures lacking evidence for routine clinical use were also identified (and entered a do-not-do list), as well as procedures in research and development. Resource allocations resulting from the priority-setting process were identified. RESULTS: Of 102 core procedures identified, 50 were assigned to high-priority groups (1-3), 29 to moderate priority groups (4-7) and 23 to low priority groups (8-10). Almost a quarter were graded 8 to 10, indicating that they may not necessarily be applied if resources are scarce. Twenty-eight procedures were assigned to the do-not-do list and 16 to the research and development list. CONCLUSIONS: In stroke services, it is possible to identify not only diagnostic procedures and interventions with high priority, but also a considerable number of items used today that have low priority or should not be used at all. Strict adherence to the guidelines would result in a substantial reallocation of resources from low-priority to high-priority areas.
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