| 1. |
- Benatar, Michael, et al.
(author)
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Safety and efficacy of arimoclomol in patients with early amyotrophic lateral sclerosis (ORARIALS-01) : a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial
- 2024
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In: Lancet Neurology. - : Elsevier. - 1474-4422 .- 1474-4465. ; 23:7, s. 687-699
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Journal article (peer-reviewed)abstract
- Background: Amyotrophic lateral sclerosis is a progressive neurodegenerative disorder leading to muscle weakness and respiratory failure. Arimoclomol, a heat-shock protein-70 (HSP70) co-inducer, is neuroprotective in animal models of amyotrophic lateral sclerosis, with multiple mechanisms of action, including clearance of protein aggregates, a pathological hallmark of sporadic and familial amyotrophic lateral sclerosis. We aimed to evaluate the safety and efficacy of arimoclomol in patients with amyotrophic lateral sclerosis.Methods: ORARIALS-01 was a multinational, randomised, double-blind, placebo-controlled, parallel-group trial done at 29 centres in 12 countries in Europe and North America. Patients were eligible if they were aged 18 years or older and met El Escorial criteria for clinically possible, probable, probable laboratory-supported, definite, or familial amyotrophic lateral sclerosis; had an ALS Functional Rating Scale-Revised score of 35 or more; and had slow vital capacity at 70% or more of the value predicted on the basis of the participant's age, height, and sex. Patients were randomly assigned (2:1) in blocks of 6, stratified by use of a stable dose of riluzole or no riluzole use, to receive oral arimoclomol citrate 1200 mg/day (400 mg three times per day) or placebo. The Randomisation sequence was computer generated centrally. Investigators, study personnel, and study participants were masked to treatment allocation. The primary outcome was the Combined Assessment of Function and Survival (CAFS) rank score over 76 weeks of treatment. The primary outcome and safety were analysed in the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03491462, and is completed.Findings: Between July 31, 2018, and July 17, 2019, 287 patients were screened, 245 of whom were enrolled in the trial and randomly assigned. The modified intention-to-treat population comprised 239 patients (160 in the arimoclomol group and 79 in the placebo group): 151 (63%) were male and 88 (37%) were female; mean age was 57·6 years (SD 10·9). CAFS score over 76 weeks did not differ between groups (mean 0·51 [SD 0·29] in the arimoclomol group vs 0·49 [0·28] in the placebo group; p=0·62). Cliff's delta comparing the two groups was 0·039 (95% CI –0·116 to 0·194). Proportions of participants who died were similar between the treatment groups: 29 (18%) of 160 patients in the arimoclomol group and 18 (23%) of 79 patients in the placebo group. Most deaths were due to disease progression. The most common adverse events were gastrointestinal. Adverse events were more often deemed treatment-related in the arimoclomol group (104 [65%]) than in the placebo group (41 [52%]) and more often led to treatment discontinuation in the arimoclomol group (26 [16%]) than in the placebo group (four [5%]).Interpretation: Arimoclomol did not improve efficacy outcomes compared with placebo. Although available biomarker data are insufficient to preclude future strategies that target the HSP response, safety data suggest that a higher dose of arimoclomol would not have been tolerated.Funding: Orphazyme.
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| 2. |
- Beno, Anja, et al.
(author)
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Does employer involvement in primary health care enhance return to work for patients with stress-related mental disorders? a cluster randomized controlled trial
- 2023
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In: BMC Primary Care. - 2731-4553. ; 24:1
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Journal article (peer-reviewed)abstract
- BackgroundStress-related disorders have become a major challenge for society and are associated with rising levels of sick leave. The provision of support to facilitate the return to work (RTW) for this patient group is of great importance. The aim of the present study was to evaluate whether a new systematic procedure with collaboration between general practitioners (GPs), rehabilitation coordinators (RCs) and employers could reduce sick leave days for this patient group.MethodEmployed patients with stress-related diagnoses seeking care at primary health care centres (PHCCs) were included in either the intervention group (n = 54), following the systematic intervention procedure, or the control group (n = 58), receiving treatment as usual (TAU). The intervention included a) a training day for participant GPs and RCs, b) a standardised procedure for GPs and RCs to follow after training, c) the opportunity to receive clinical advice from specialist physicians in the research group. Outcome measures for RTW were sick leave days.ResultsThe median number of registered gross sick leave days was lower for the control group at six, 12 and 24 months after inclusion, but the difference was not statistically significant. The control group had significantly fewer net sick leave days at three months (p = 0.03) at six months (p = 0.00) and at 12-months follow-up (p = 0.01). At 24 months, this difference was no longer significant.ConclusionsThe PRIMA intervention, which applied a standardized procedure for employer involvement in the rehabilitation process for patients with stress-related disorders, actually increased time to RTW compared to TAU. However, at 24 months, the benefit of TAU could no longer be confirmed. The study was registered on 16/01/2017 (ClinicalTrials.gov, NCT03022760).
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| 4. |
- Holmgren, Cecilia, et al.
(author)
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Charge nurses’ perceived experience in managing daily work and major incidents in emergency departments : A qualitative study
- 2022
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In: Australasian Emergency Care. - : Elsevier. - 2588-994X. ; 25:4, s. 296-301
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Journal article (peer-reviewed)abstract
- Background Emergency department charge nurses are expected to oversee the quality of patient care, direct work, and the allocation of resources. The charge nurse is the unit’s frontline leader, and he/she must have proper leadership training and support to carry out duties effectively. This study explores how charge nurses perceive their role in managing daily work and major incidents at the emergency department. Methods A qualitative study based on focus group discussions using a semi-structured interview. Participants were 12 charge nurses from four Swedish emergency departments. Results For data analysis, a systematic text condensation method was used. The analysis of data generated four categories: (1) Coping with chaos; (2) Need for further training; (3) Feeling of inadequacy; and (4) Lack of strategies. Conclusions The study concluded that the emergency department charge nurse has frontline duties that are diverse, multifaceted, require good leadership qualities, and lack detailed job description. Charge nurses confront many challenges in their daily work, often with little training or the opportunity to develop in their professional. This study provides understanding of the concerns charge nurses hold about working as frontline leaders and that departmental heads must support the education and training of their charge nurses.
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| 5. |
- Holmgren, Kristina, 1977-, et al.
(author)
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KNOGA. Fossilfri framdrift för tunga långväga godstransporter på väg : kostnadsfördelning och risker för olika aktörer (Executive summary)
- 2021
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Reports (other academic/artistic)abstract
- Användningen av förnybar energi i transportsektorn behöver öka för att vi ska nå de svenska klimatmålen om minskade växthusgasutsläpp från inrikes transporterna med 70 procent till 2030, och nettonollutsläpp från samtliga sektorer till 2045. Ökningen av förnybara drivmedel behöver ske i alla segment och över hela fordonsflottan.Idag används främst diesel som drivmedel för tunga långväga godstransporter på väg men det finns alternativ för fossilfri framdrift. Denna studie har kvantifierat kostnadsstrukturer och analyserat riskfördelning mellan olika aktörer för fossilfria framdriftstekniker för tunga långväga godstransporter på väg och jämfört dem med alternativet att fortsätta använda diesel som drivmedel. Följande tekniker är inkluderade i studien: biobränslen (flytande och gasformiga), batterielektriska fordon (BEV), elvägar (tre olika tekniker), vätgasdrivna bränslecellsfordon (H2-FCEV) samt elektrobränslen. Beräkningar görs för år 2030 och 2045. Från de fem huvudkategorierna för fossilfri framdrift har ett antal representativa motortekniker, bränsleproduktionstekniker och råvaror valts ut för att analyseras i detalj. Detta har resulterat i ett trettiotal olika fossilfria alternativ till dagens användning av fossil diesel
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| 6. |
- Holmgren, Kristina, 1977-, et al.
(author)
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KNOGA. Fossilfri framdrift för tunga långväga transporter på väg : Kostnadsfördelning och risker för olika aktörer
- 2021
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Reports (other academic/artistic)abstract
- För att nå de svenska klimatmålen om att minska växthusgasutsläppen från inrikes transporter (undantaget flyget) med 70% till 2030 och om att nå nettonollutsläpp för samtliga sektorer till 2045behöver användningen av förnybar energi i transportsektorn öka. Denna studie kvantifierar kostnadsstrukturer och analyserar riskfördelning mellan olika aktörer förfossilfria framdriftstekniker för tunga långväga godstransporter på väg. Följande tekniker är inkluderade i studien: biobränslen (flytande och gasformiga), elfordon med batterier (BEV), elvägar (tre olika tekniker), vätgasdrivna bränslecellsfordon samt elektrobränslen.I denna studie görs också en jämförelse avseende de olika framdrivningsteknikernas växthusgasutsläpp där bränsle/energianvändning, batteriproduktion (för tekniker med elektrisk framdrivning) och elvägsinfrastruktur inkluderas.Analyserna görs för två typer av lastbilar: HGV40 och HGV60. HGV40 är en tung lastbil med en tillåten bruttovikt om max 40 ton som används inom hela Europa. HGV60 är en lastbil med en tillåten bruttovikt om max 60 ton som står för merparten av transportarbetet med lastbil i Sverige, men som bara är tillåten i ett fåtal andra europeiska länder. Beräkningar görs för år 2030 och 2045.Kostnader för de olika teknikalternativen redovisas i vad vi i denna studie har valt att kalla relativ mobilitetskostnad. Den relativa mobilitetskostnaden inkluderar: fordonens investeringskostnader, service och reparationer av fordon samt drivmedelskostnader. Drivmedelskostnaderna består av produktions-och distributionskostnader för drivmedel, där distributionskostnaderna inkluderar bådedirekta kostnader för distribution av drivmedel från produktionsanläggning till pump, samt investeringskostnader och underhåll för distributionsinfrastruktur (d.v.s. underhåll för elväg, ladd-infrastruktur eller tankstation). Genom att tydligt presentera de olika delarnas bidrag till den relativa mobilitetskostnaden erhålls en bild av hur kostnaderna för de olika framdrivningsteknikerna fördelar sig mellan fordonsinvestering, service och reparation av fordon, drivmedelsproduktions-kostnader och distributionsinfrastruktur. Alla kostnader beräknas utan skatter och avgifter. En analys som visar påverkan på den relativa mobilitetskostnaden då man belastar alternativen med en CO2-kostnad för bränsle/energianvändningen inkluderas också i studien
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| 7. |
- Tengelin, Ellinor, 1982-, et al.
(author)
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Swedish managers' experience-based understanding of the Capacity to work in employees with Common Mental Disorders : a Focus Group Study.
- 2022
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In: Journal of occupational rehabilitation. - : Springer Science and Business Media LLC. - 1053-0487 .- 1573-3688. ; 32:4, s. 685-696
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Journal article (peer-reviewed)abstract
- PURPOSE: Understanding of the capacity to work among employees with common mental disorders (CMDs) is important, but contemporary knowledge on this issue lacks the managers' perspective. The aim of this study was to explore and describe managers' experience-based understanding of capacity to work in employees with CMD.METHODS: A qualitative focus group study was designed. Managers with experience in supporting employees with CMD were recruited via organizations and networks. Eight focus group interviews with 31 participants took place.RESULTS: The analysis resulted in five categories. (1) Capacity to mentally focus on work tasks decreases or disappears, with negative consequences for work output. (2) Capacity to commit to continuous and coherent task changes, making tasks that span longer periods of time difficult. (3) Capacity to independently adapt to the needs of the situation decreases, and employees need more guidance and instructions than usual. (4) Capacity to keep up professional appearances is reduced, and the employees struggle with the professional role. (5) Ability to interact socially and professionally decreases, which potentially causes conflicts at the workplace.CONCLUSIONS: This study adds managers' perspective to the increasing knowledge on how capacity to work is influenced by CMDs. Managers understand CMDs in employees as changed, reducing the capacities needed for occupational functioning. A deeper understanding of reduced capacity to work is needed to adapt workplaces, and our findings can facilitate work accommodations for employees with CMDs.
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| 8. |
- Wachtler, Caroline, et al.
(author)
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“Returning to the core tasks”: a qualitative interview study about how general practitioners in home health care solved problems during the COVID-19 pandemic
- 2024
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In: Scandinavian Journal of Primary Health Care. - 0281-3432 .- 1502-7724. ; 42:1, s. 91-100
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Journal article (peer-reviewed)abstract
- Objective: Optimizing care at home, or home health care (HHC), is necessary as the population of care-dependent older people receiving care at home steadily increases. The COVID-19 pandemic tested Swedish primary care professionals as they provided HHC for a population of very frail older homebound people, but a better understanding of what healthcare workers did to manage the crisis may be useful for the further development of HHC. In this study, we aimed to understand how HHC physicians solved the problems of providing home healthcare during the pandemic to learn lessons on how to improve future HHC. Methods: This is a qualitative study of individual interviews with 11 primary care physicians working in HHC (8 women) from 7 primary care practices in Region Stockholm, Sweden. Interviews were conducted between 1 December 2020, and 11 March 2021. The data were analyzed using inductive thematic analysis. Results: We generated an overarching theme in our analysis: Physicians focus on core tasks and professional values in response to crisis. This theme incorporated three underlying subthemes describing this response: physicians prioritize and resolve ethically challenging situations in new ways, cultivate the patient perspective, and build on existing teams. Conclusion: This study indicates that a healthcare system that gives HHC physicians agency to focus on core tasks and professional values could promote person-centered care.
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