Switching From Originator to Biosimilar Human Growth Hormone Using Dialogue Teamwork: Single-Center Experience From Sweden

INTRODUCTION: A new treatment plan was implemented at Skåne University Hospital, on economic grounds, for children requiring recombinant human growth hormone (rhGH) treatment. This involved switching patients from treatment with originator rhGHs to treatment with a biosimilar rhGH, somatropin (Omnitrope(®)), using a Dialogue Teamwork approach. The feasibility of using this approach to implement the switch of treatment was assessed, as well as the impact of the switch on treatment efficacy and cost of therapy. METHODS: As part of the Dialogue Teamwork approach, patients/parents received several opportunities for dialogue and sources of information, including discussions with the Head of Department, the responsible physician and a specialized endocrinology nurse. Height and height standard deviation score (HSDS) data were plotted for each individual patient (N = 98). A modeling approach was also used, to predict growth after switching to biosimilar rhGH; the predictions were then compared to the actual observed height after the switch. Costs to the clinic of rhGH therapy were calculated between May–August 2009 and May–August 2012. RESULTS: Of the 102 patients offered the switch, 98 accepted. Height and HSDS data indicated there was no negative impact on growth velocity after the switch to biosimilar rhGH. Modeling demonstrated that observed growth following the switch was consistent with predicted growth based on data before patients were switched. There were no reports of serious or unexpected adverse drug reactions following the switch to biosimilar rhGH. Following the switch, the cost to the clinic of rhGH treatment decreased from approximately 6 million SEK (May–August 2009) to approximately 4 million SEK (May–August 2012). This corresponds to an annual saving of 6 million SEK (€650,000). CONCLUSION: Patients were successfully switched from originator to biosimilar rhGH (somatropin), with no negative impact on growth, and no serious or unexpected adverse drug reactions. The switch from originator to biosimilar rhGH is associated with substantial cost savings

The Association between Pre- and Post-Migration Wellbeing Factors with Integration among Russian, Somali, and Kurdish Origin Women in Finland

Peer reviewe

Neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (TTM2)

Background: This study is designed to provide detailed knowledge on cognitive impairment after out-of-hospital cardiac arrest (OHCA) and its relation to associated factors, and to validate the neurocognitive screening of the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2-trial), assessing effectiveness of targeted temperature management after OHCA. Methods: This longitudinal multi-center clinical study is a sub-study of the TTM2-trial, in which a comprehensive neuropsychological examination is performed in addition to the main TTM2-trial neurocognitive screening. Approximately 7 and 24 months after OHCA, survivors at selected study sites are invited to a standardized assessment, including performance-based tests of cognition and questionnaires of emotional problems, fatigue, executive function and insomnia. At 1:1 ratio, a matched control group from a cohort of acute myocardial infarction (MI) patients is recruited to perform the same assessment. We aim to include 100 patients per group. Potential differences between the OHCA patients and the MI controls at 7 and 24 months will be analyzed with a linear regression, using composite z-scores per cognitive domain (verbal, visual/constructive, working memory, episodic memory, processing speed, executive functions) as primary outcome measures. Results from OHCA survivors on the main TTM2-trial neurocognitive screening battery will be compared with neuropsychological test results at 7 months, using sensitivity and specificity analyses. Discussion: In this study we collect detailed information on cognitive impairment after OHCA and compare this to a control group of patients with acute MI. The validation of the TTM2 neurocognitive screening battery could justify its inclusion in routine follow-up. Our results may have a potential to impact on the design of future follow-up strategies and interventions after OHCA

Low physical activity level in out-of-hospital cardiac arrest survivors with obesity, mobility problems and cognitive impairment: Results from the TTM2 trial

To describe the level of physical activity 6 months after an out-of-hospital cardiac arrest (OHCA) and to explore potential risk factors of a low level of physical activity. Post-hoc analyses of the international multicentre Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac arrest (TTM2) trial. At 6 months, survivors at 61 sites in Europe, Australia and New Zeeland were invited to a follow-up. The participants answered two questions on self-reported physical activity. Answers were categorized as a low, moderate, or high level of physical activity and further dichotomized into a low versus moderate/high level of physical activity. Potential risk factors for a low level of physical activity were collected and investigated by univariable and multivariable logistic regression. At 6 months, 807 of 939 (86%) OHCA survivors answered the two questions of physical activity; 34% reported a low, 44% moderate and 22% high level of physical activity. Obesity (OR = 1.75, 95% CI 1.10-2.77, p = 0.018), mobility problems by EuroQol 5 dimensions 5 levels (OR = 1.73, 95% CI 1.06-2.84, p = 0.029), and cognitive impairment by Symbol Digit Modalities Test (OR = 1.78, 95% CI 1.13-2.82, p = 0.013) were significantly associated with a low level of physical activity in the multivariable analysis. One third of the OHCA survivors reported a low level of physical activity. Obesity, mobility problems, and cognitive impairment were associated with a low level of physical activity. NCT02908308. [Abstract copyright: Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.

Effects of Hypothermia vs Normothermia on Societal Participation and Cognitive Function at 6 Months in Survivors After Out-of-Hospital Cardiac Arrest

ImportanceThe Targeted Hypothermia vs Targeted Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial reported no difference in mortality or poor functional outcome at 6 months after out-of-hospital cardiac arrest (OHCA). This predefined exploratory analysis provides more detailed estimation of brain dysfunction for the comparison of the 2 intervention regimens.ObjectivesTo investigate the effects of targeted hypothermia vs targeted normothermia on functional outcome with focus on societal participation and cognitive function in survivors 6 months after OHCA.Design, Setting, and ParticipantsThis study is a predefined analysis of an international multicenter, randomized clinical trial that took place from November 2017 to January 2020 and included participants at 61 hospitals in 14 countries. A structured follow-up for survivors performed at 6 months was by masked outcome assessors. The last follow-up took place in October 2020. Participants included 1861 adult (older than 18 years) patients with OHCA who were comatose at hospital admission. At 6 months, 939 of 1861 were alive and invited to a follow-up, of which 103 of 939 declined or were missing.InterventionsRandomization 1:1 to temperature control with targeted hypothermia at 33 °C or targeted normothermia and early treatment of fever (37.8 °C or higher).Main outcomes and measuresFunctional outcome focusing on societal participation assessed by the Glasgow Outcome Scale Extended ([GOSE] 1 to 8) and cognitive function assessed by the Montreal Cognitive Assessment ([MoCA] 0 to 30) and the Symbol Digit Modalities Test ([SDMT] z scores). Higher scores represent better outcomes.ResultsAt 6 months, 836 of 939 survivors with a mean age of 60 (SD, 13) (range, 18 to 88) years (700 of 836 male [84%]) participated in the follow-up. There were no differences between the 2 intervention groups in functional outcome focusing on societal participation (GOSE score, odds ratio, 0.91; 95% CI, 0.71-1.17; P = .46) or in cognitive function by MoCA (mean difference, 0.36; 95% CI,−0.33 to 1.05; P = .37) and SDMT (mean difference, 0.06; 95% CI,−0.16 to 0.27; P = .62). Limitations in societal participation (GOSE score less than 7) were common regardless of intervention (hypothermia, 178 of 415 [43%]; normothermia, 168 of 419 [40%]). Cognitive impairment was identified in 353 of 599 survivors (59%).ConclusionsIn this predefined analysis of comatose patients after OHCA, hypothermia did not lead to better functional outcome assessed with a focus on societal participation and cognitive function than management with normothermia. At 6 months, many survivors had not regained their pre-arrest activities and roles, and mild cognitive dysfunction was common.Trial RegistrationClinicalTrials.gov Identifier: NCT0290830

Processing unit resources in a distributed computing systems

The described program is designed for collecting, storing and processing data of distributed file system

Omille siiville : nuorten kokemuksia asumisharjoittelusta ja itsenäistymisestä lastenkodista

Opinnäytetyössämme tarkastelemme Toivolan oppilaskodin asumisharjoittelua ja sen tukea nuoren itsenäistymisessä. Asumisharjoittelu koostuu asumiskurssista ja asumisharjoittelujaksoista Toivolan oppilaskodin itsenäistymisasunnoissa. Opinnäytetyömme tarkoituksena on kartoittaa asumisharjoittelun läpikäyneiden nuorten kokemuksia. Nuorten kokemusten perusteella pyrimme löytämään asumisharjoittelukokonaisuuden toimivia ja kehitettäviä puolia sekä luomaan kehitysehdotuksia. Käsittelemme opinnäytetyössämme asumisharjoittelua ja itsenäistymistä lastenkodista elämänhallinnan, sosiaalipedagogiikan ja syrjäytymisen näkökulmasta. Opinnäytetyömme on kvalitatiivinen. Keräsimme aineiston haastattelemalla viittä Toivolan oppilaskodista vuosina 2006 2009 poismuuttanutta nuorta, jotka olivat osallistuneet asumisharjoitteluun. Haastattelumenetelmänä käytimme teemahaastattelua, jossa teemoina olivat asuminen, rahankäyttö, ruoanlaitto ja yleinen siisteys, vastuu ja velvollisuudet, viralliset kontaktit, yksinäisyyden kokeminen sekä omahoitajan rooli. Aineiston analyysissä käytimme teemoittelua. Tuloksista selvisi, että nuoret kokivat asumisharjoittelun tarpeelliseksi osaksi itsenäistymistä. Nuorten mielestä asumisharjoittelu oli kokonaisuudessaan hyvä ja opettavainen kokemus. Nuoret toivat esiin hyviä eri teemoihin liittyviä kehitysehdotuksia, joiden avulla asumisharjoittelu tukisi paremmin itsenäistymistä ja valmistautumista poismuuttoon. Tuloksissa korostui yksilöllisten tarpeiden ja lähtökohtien huomioimisen tärkeys asumisharjoittelussa. Tulosten perusteella asumisharjoittelusta on tärkeä luoda jokaiselle nuorelle yksilöllinen kokonaisuus, jossa huomioidaan hänen jo osaamansa taidot sekä harjoittelua vaativat alueet. Toivolan oppilaskodin tulisi kehittää asumisharjoitteluun liittyviä käytäntöjä yhtenäisemmiksi ja yksilön elämänhallintaa tukevammiksi. Tärkeässä roolissa nuoren itsenäistymisessä on hänen omahoitajansa ja tämän antama tuki, johon tulisi kiinnittää erityisesti huomiota asumisharjoittelun aikana.This study analyzed a practice period in independent living in Toivola children´s home. The practice period consists of a living course and living in a practice apartment. The purpose of this study was to analyze experiences of the young people who participated in the practice period and find structures that were good and those that needed development and create development suggestions. Our perspective in this study was life management, social pedagogy and exclusion. The study was qualitative. The data was gathered with theme interviews. Five young people that took part in the practice period were interviewed. The analysis was carried out by classifying data into various themes. The themes were living, spending money, cooking and cleaning, responsibilities, official contacts, loneliness and the role of a key worker. The results showed that these young people considered the practice period useful and an important part of independency. They considered the practice period a positive and educational experience as a whole. The young people brought forth good development suggestions in different themes which could contribute to young people´s independence and preparations for moving away from the children´s home. The results emphasized the importance of the participants’ personal needs and basic situations in the practice period in independent living. The results seem to indicate that the practice period should be tailored to each young person's needs. This way a young person´s skills and areas that need support are taken into account. The children´s home should make the practice period policy more solid and supportive in the young person´s life management. The role and support of a key worker is important in young people’s independency. This should be taken into account to a greater extent when young people live in a practice apartment