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- 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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| 2. |
- 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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| 3. |
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| 4. |
- 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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| 6. |
- Ängskog, Per, 1964-
(författare)
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Protection of Complex Infrastructure Systems against Intentional Electromagnetic Interference
- 2023
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- In this thesis the effects of, and defense against, antagonistic attacks using Intentional Electromagnetic Interference (IEMI) are treated; especially when targeting infrastructure critical to society (CI).IEMI as a means to disturb or destroy electronic equipment draws its roots from military methods to interrupt or interfere with enemy activities. Especially since the end of the cold war these methods have been adopted by various criminal groups and have been utilized on several occasions. How often and the severity of the outcome is difficult to know since it is difficult to understand whether it is IEMI or something else that causes disturbances in computers, networks, sensors, and other types of electronic equipment. Contributing to this is the fact that IEMI does notl eave any viable forensic evidence when used. This, together with low interest in reporting security flaws publicly suggests that the number of incidents is underreported. Although not a large-scale problem, it could be devastating for the trust in the society’s ability to defend itself and its citizens. As IEMI as an antagonistic method has the capacity to interrupt the function of CIs, the need for protective measures has been raised by the Swedish Civil Contingencies Agency (MSB). Few reported cases, together with the antagonistic nature of the threat, render probabilistic risk analysis inadequate for the defense of infrastructures critical to society. Instead, a shift towards resilience engineering and vulnerability analysis is suggested to manage these antagonistic threats. As part of building protection improvement, the shielding efficiency of different generations of windows and panes has been measured and analyzed.
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| 7. |
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| 8. |
- Ceccato, Vania, Professor, 1968-, et al.
(författare)
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The impact of fear on young people’s mobility
- 2021
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Ingår i: European Journal of Criminology. - : SAGE Publications. - 1477-3708 .- 1741-2609.
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Tidskriftsartikel (refereegranskat)abstract
- This study makes use of a dataset recently collected among young people in Stockholm, Sweden (N = 1122), to investigate the impact of fear on young people?s mobility and precautionary behaviour, after controlling for previous victimization as well as situational characteristics of daily trips. Geographical Information Systems (GIS) and logistic regression models underlie the methodology of the study. Previous victimization, especially for sexual crimes, triggers precautionary behaviour among young people using trains and the metro. Signs of poorly maintained transit environments also affect young riders? mobility patterns, as they state that they avoid particular stations or routes at particular times. Informed by principles of environmental criminology and the theory of fear of crime, the implications of the findings for both theory and practice are discussed.
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| 9. |
- Ceccato, Vania, Professor, 1968-, et al.
(författare)
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Young people’s victimization and safety perceptions along the trip
- 2021
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Ingår i: Nordic Journal of Criminology. - 2578-983X. ; 22:1, s. 106-125
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Tidskriftsartikel (refereegranskat)abstract
- The objective of this article is to assess whether, how and why young people’s safety perceptions vary along the trip. Informed by principles of environmental criminology, this study makes use of a dataset recently collected among young riders of public transportation (1,122 university students) in Stockholm, Sweden. Geographical Information Systems (GIS) and logistic regression models underlie the methodology of the study. Findings indicate that safety perceptions of young riders are affected by previous experience of sexual crimes but are not affected by overall victimization. More importantly, being exposed to high crime environments on the way to the metro significantly reduces young people’s safety perceptions (but not on the way to bus stops), especially for men. Drunk people tend to affect women’s safety perceptions, especially in bus systems. The article finishes by discussing the implications of the results for future research and helps advocate more inclusion of young people’s safety needs when implementing safety and transportation policies.
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| 10. |
- Ferrannini, Giulia, et al.
(författare)
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Antiphospholipid antibodies in patients with dysglycaemia : A neglected cardiovascular risk factor?
- 2020
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Ingår i: Diabetes & Vascular Disease Research. - : SAGE PUBLICATIONS LTD. - 1479-1641 .- 1752-8984. ; 17:3
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Tidskriftsartikel (refereegranskat)abstract
- Background: Cardiovascular disease is a serious complication in patients with dysglycaemia, defined as either type 2 diabetes or impaired glucose tolerance. Research focusing on the identification of potential markers for atherothrombotic disease in these subjects is warranted. The antiphospholipid syndrome is a common acquired prothrombotic condition, defined by a combination of thrombotic events and/or obstetric morbidity and positivity of specific antiphospholipid antibodies. Available information on antiphospholipid antibodies in dysglycaemia is scarce. Objective: This study investigates the association between antiphospholipid antibodies and dysglycaemia. Patients/Methods: The PAROKRANK (periodontitis and its relation to coronary artery disease) study included 805 patients, investigated 6-10 weeks after a first myocardial infarction, and 805 matched controls. Participants without known diabetes (91%) underwent an oral glucose tolerance test. Associations between antiphospholipid antibodies (anti-cardiolipin and anti-beta 2 glycoprotein-I IgG, IgM and IgA) and dysglycaemia were analysed. Results: In total, 137 (9%) subjects had previously known type 2 diabetes and 371 (23%) newly diagnosed dysglycaemia. Compared with the normoglycaemic participants, those with dysglycaemia had a higher proportion with first myocardial infarction (61% vs 45%,p < 0.0001) and were more often antiphospholipid antibody IgG positive (8% vs 5%;p = 0.013). HbA1c, fasting glucose and 2-h glucose were significantly associated to antiphospholipid antibody IgG. Odds ratios (ORs) were 1.04 (95% confidence interval [CI] 1.02-1.06), 1.14 (95% CI 1.00 - 1.27) and 1.12 (95% CI 1.04 - 1.21), respectively, after adjustments for age, gender and smoking. Conclusions: This study reports an association between antiphospholipid antibody IgG positivity and dysglycaemia. Further studies are needed to verify these findings and to investigate if antithrombotic therapy reduces vascular complications in antiphospholipid antibody positive subjects with dysglycaemia.
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