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Background: The Scandinavian countries have a long history of implementing social interventions, but the interventions have not been examined using randomised controlled trials until relatively recently compared with countries like the United States and the United Kingdom. Purpose: The purpose of this paper is to examine the history of randomised controlled trials in Scandinavian compulsory schools (grades 0-10; pupil ages 6-15). Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries Denmark, Norway, and Sweden. Methods: To locate relevant trials, we performed a systematic search of four bibliographic databases and a search for grey literature. Results were combined with trials located through direct contact with researchers and government officials. A trial was included if one or more interventions were randomly assigned to groups of students and carried out in a school setting with the primary aim of improving the academic performance of children aged 6-15 in grades 0-10 in Denmark, Norway, or Sweden. We included both conducted and ongoing trials. Publications that seemed relevant were screened based on full-text versions. Data extraction included information from the included studies on grade level, study period, sample size (N), project owner, funding source, and theme. In addition, we conducted two semi-structured interviews by phone or in person with central employees in funding agencies and ministries and 25 correspondences with researchers and policymakers. Findings and conclusion: RCTs in grades 0-10 were few in all of Scandinavia until about 2011, after which there was an increase in all three countries, although at different rates. The largest number of trials has been conducted in Denmark, and the increase is more marked in Denmark and Norway compared with Sweden. International trends towards more impact evaluations and results from international comparisons such as PISA have likely affected the development in all countries, but while many trials in Denmark and Norway are the result of policy initiatives, only one such example in Sweden was identified. We believe the lack of government initiatives to promote RCTs in Sweden is the most likely explanation for the differences across the Scandinavian countries. Funding and coordination from the government are often crucial for the implementation of RCTs and are likely more important in smaller countries such as the Scandinavian ones. Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue.

It has been claimed that physical activity has a positive effect on not only health but also on school performance. Using data from a randomised school-intervention study, this paper investigates whether different interventions promoting physical activity affect school performance in primary school children. The results indicate that on average, the interventions have a very limited beneficial impact on the pupils' performance. The effects are mostly insignificant, and in some cases even negative. These results are relevant when considering how general school resources and resources targeted towards physical activity in particular should be invested to improve school performance.

Understanding the effects of class size reduction (CSR) has been an enduring issue in education. For the past 3 decades, Project STAR has stimulated research and policy discussions regarding the effects of CSR on a variety of outcomes. Schanzenbach (2007) reviewed STAR studies and concluded that small classes improved student academic outcomes. Since her review, however, some research has challenged this conclusion. This paper reviews these recent challenges, comparing past and recent studies. This review is considered together with studies on large-scale CSR policies in the US and CSR studies outside the US. We conclude by suggesting a direction for future research.

Aim: To evaluate the effects of a physical activity programme on sedentary behaviour and physical activity in ambulant individuals with Rett syndrome (RTT). Method: In this multicentre randomized waitlist‐controlled trial, we recruited 43 ambulatory individuals with RTT in Australia and Denmark. Adequate baseline data were obtained from 38 participants (mean age 20 years, range 6–41, SD 10 years 6 months, one male). All completed the trial. Participants received 12 weeks of usual care (n = 19) or a goal‐based, telehealth‐supported programme in which activities occurred in their familiar environments (n = 19). Sedentary time and daily steps were assessed at baseline, post‐test, and 12‐week follow‐up. The data analyst was blinded to group allocation. Results: Sedentary time decreased in the intervention group by 2.7% (95% confidence interval [CI] −6.0 to 0.6) and increased in the control group by 1.3% (95% CI −4.8 to 7.4). Intervention and control groups increased the number of their steps per day by 264.7 (95% CI −72.2 to 601.5) and 104.8 (95% CI −178.1 to 387.7) respectively. No significant differences were found on any outcomes at post‐test. There were three minor adverse events. Interpretation: A goal‐based telehealth intervention seemed to produce small improvements in physical activity for individuals with RTT. Families require more support to increase these individuals' extremely low physical activity levels. What this paper adds: A telehealth‐supported intervention may produce small changes in physical activity in Rett syndrome (RTT).Increasing physical activity in individuals with RTT is challenging for caregivers.Families require substantial out‐of‐home support to increase their children's activity levels. [ABSTRACT FROM AUTHOR]

Despite demonstrated effectiveness as a psychosocial intervention for youth diagnosed with attention-deficit/hyperactivity disorder (ADHD), behavioural parent training (BPT) remains inaccessible while disorder rates increase globally. Previously, Chacko and Scavenius found that the Caring in Chaos (CiC) BPT model leveraged the advantages of community health settings, resulting in improved child and parent outcomes, prompting a need to replicate these findings. This paper reports on the effects of the CiC BPT model on the previous waitlist, untreated sample from Chacko and Scavenius. Results confirm previous findings, demonstrating CiC BPT improves parenting behaviour, competence, stress, depressive symptoms, and child impairment. [ABSTRACT FROM AUTHOR]

FURCA (Follow-Up after Rectal Cancer) is a multi-centre randomised trial comparing patient-led follow-up with standard outpatient follow-up. This paper reports one-year follow-up data from the FURCA trial on selected secondary outcomes including type and number of contacts, patient-reported involvement and satisfaction with health care services during follow-up. Patients with rectal cancer (stage < IV) from four Danish surgical centres were randomised (1:1) into intervention (education and self-referral to project nurse) or standard follow-up (routine clinical doctor visits). The present analysis involved data on hospital contacts during the first year after surgery, patient involvement and satisfaction measured at one year, and baseline patient-reported and clinical variables. Of 512 eligible patients, 168 were allocated to patient-led follow-up (intervention) and 168 to standard follow-up (control). The total number of hospital contacts in the intervention arm did not differ significantly from the number of contacts in the control arm (p = 0.44). More patients had ≥15 contacts in the intervention arm than in the control arm (p = 0.004). The total number of outpatient doctor visits was significantly lower in the intervention arm (p < 0.001). Patients in both arms rated involvement and satisfaction high; yet patients in the intervention arm scored significantly higher on two of six items regarding involvement and all five items regarding satisfaction. Of the 168 patients in the intervention arm, 43% made direct contact (self-referral) to the project nurse, and 14 of these patients (8%) had ≥4 contacts. The primary reason for self-referral was bowel dysfunction. The findings indicate the value of a patient-led follow-up program in terms of direct access and more individually tailored intervention based on patients' needs, with most tasks being managed by nurses. Patient-led follow-up came with improved patient-perceived involvement and satisfaction; thus, it was both acceptable and favourable for the patients. [ABSTRACT FROM AUTHOR]

Objectives: This paper examines whether the posting of sticker decals indicating the use of forensic property marking deters burglary. Methods: The study is a randomized controlled trial (RCT). The sampling frame includes all (N = 6603) single-family houses in the municipality of Aarhus, Denmark, that were burgled once or more during the 4 years prior to the experiment. Houses were randomly assigned to treatment (n = 3378) and control (n = 3225). Treatment houses were offered a free forensic property marking kit and asked to post sticker decals around their front doors indicting their use of the product. Control households were not contacted. Results: A process evaluation determined that only one-third (n = 1080) of the houses assigned to treatment requested property marking kits and posted stickers as instructed. An intention-to-treat (ITT) effect analysis was based on the full treatment group despite a low (32%) compliance rate. At the end of a 15½-month observation period, the full treatment group had experienced 21% fewer burglaries than the control group – a difference that is both substantively and statistically significant (χ2 = 5.305, p = 0.021 n = 6608). Analysis revealed that the preventive effect was limited to the beginning of the observation period and declined thereafter. It is therefore possible that some of the overall result may have been due to an "availability effect," i.e., a heightened vigilance induced by the initial contact letter. Conclusions: The preventive effect of treatment seems incontestable. This said, the full pattern of results suggests that the reduction in burglary was likely due to a combination of treatment and availability effects. [ABSTRACT FROM AUTHOR]

Background: Results from previous studies suggest that bodily movements, spanning from gestures to whole-body movements, integrated into academic lessons may benefit academic learning. However, only few studies have investigated the effects of movement integrated into reading practice. The PLAYMORE study aims to investigate the effects of two interventions focusing on a close and meaningful coupling between bodily movement and academic content on early pre-reading and word recognition skills in children. Further, the study aims to compare two interventions involving either hand movements (i.e. using arms and hands) or whole-body movements (i.e. using the whole body). Potential mediating factors underlying the link between bodily movement on early pre-reading and word recognition skills will be explored.Methods/design: The PLAYMORE study will be conducted as a three-armed randomized controlled trial including children aged five to six years recruited from four schools in the Copenhagen area, Denmark. Stratified by class, children will be randomly allocated to one of three 8-week intervention/control periods: 1) teaching involving whole-body movements, 2) teaching involving hand movements (i.e. arms and hands) or 3) teaching involving minimal motor movements (i.e. seated on a chair using paper and pencil). Outcome measurements, including pre-reading and word recognition skills, will be collected before and after the intervention period to assess the intervention effects. This study protocol follows the SPIRIT guidelines.Discussion: The PLAYMORE study will add to the current knowledge concerning the link between bodily movement and academic performance with important details about pre-reading and word recognition skills in preschool children. If effective, evaluation of the implementation of the PLAYMORE program should be conducted in order to investigate whether the effects can be transferred into standard school settings. The PLAYMORE study will lay the foundation for future research that have the potential to inform the political and scientific debate and importantly, to provide teachers with detailed information of how to implement movements effectively during teaching in order to support and motivate children in the process of learning to read.Trial Registration: The study was retrospectively registered in ClinicalTrials.gov ( NCT04618822 ) the 5th of November 2020. [ABSTRACT FROM AUTHOR]

Background: The Movethehip trial investigates the effectiveness of an exercise and patient education intervention for adults with acetabular dysplasia. The intervention involves eight tailored one-to-one sessions with trained providers who employ supportive feedback tools. The present protocol reports a planned process evaluation, which aims to determine how the intervention functions by examining the implementation of the intervention (process, dose and reach), its acceptability, mechanisms of change and the influence of contextual factors. Methods: Two hundred trial participants aged 18–50 years will be recruited from a University Hospital in Denmark and randomised to the intervention or control group. Approximately ten providers will deliver the intervention. The process evaluation adopts a concurrent mixed-methods design. The implementation will be assessed using self-report questionnaires (at baseline and 6-month follow-up), training records and semi-structured focus group interviews with intervention providers (n = 10) and healthcare managers (n = 4–6). The mechanisms of change will be explored through semi-structured one-to-one interviews (at baseline and 6-month follow-up) with 15–20 purposefully sampled participants and by measuring changes in health outcomes (self-reported pain, physical functioning and quality of life completed at baseline and at 3- and 6-month follow-up). Additionally, change will be measured through an explorative examination of associations between dose and change in health outcomes, applying simple linear regression models. The acceptability of the intervention and the influence of contextual factors will be explored through one-to-one participant interviews and focus group interviews with 4–6 healthcare managers. The interviews will focus on expectations, experiences, events, personal understandings and interaction with interpersonal and organisational aspects. Interview data will be analysed using theoretical thematic analyses, and findings will be merged with quantitative data and reported jointly on a theme-by-theme basis. Discussion: The process evaluation conducted as part of the MovetheHip trial will illuminate how the intervention functions, and if the intervention is proven effective, the findings of the evaluation will contribute to pinpoint how the intervention may be optimised to facilitate future up-scaling and implementation. Trial registration: The MovetheHip protocol was approved by the Committee on Health Research Ethics in the Central Denmark Region. ClinicalTrials, NCT04795843. Registered on 20 March 2021. [ABSTRACT FROM AUTHOR]

Volunteer interventions play a vital role in supporting families by offering accessible and community-based resources outside the formal professional sector. This study examines the impact of the volunteer intervention known as Family Club Denmark (FCD) on the well-being of parents and children. FCD aims to provide families with positive experiences and support relationship building. The intervention, open to families from diverse social backgrounds, comprises volunteer-led family clubs where parents and children aged 2–12 years engage in activities and meals. We allocated 510 families (363 vulnerable families) to FCD or placed them on a waiting list based on a first-come, first-served principle. We conducted baseline, post-intervention, and follow-up assessments through questionnaires, observations, and interviews. On average, families participated in 5.8 sessions, with both families and volunteers reporting high satisfaction. When compared to control families, we find that vulnerable FCD parents feel more confident playing with their children (p = 0.04, [0.01; 0.40], d = 0.25), require less assistance in playing with their children (p = 0.01, [−0.34; −0.05], d = 0.33), and report that their children have a more challenging time forming friendships (p = 0.01, [−0.51; −0.09], d = 0.29). However, we did not find significant effects on mental health, parenting stress, self-efficacy, self-worth, family routines, or child well-being. We observed similar results for the full sample. The discovery that parents feel more confident playing with their children after participating in FCD highlights the vital role of volunteer-based interventions in enhancing parental engagement and fostering positive parent–child interactions. Trial registration: ClinicalTrials.gov NCT03657888 (registered 29 August 2018). [ABSTRACT FROM AUTHOR]

Background: Osteoarthritis (OA) has long been considered as a degenerative disease of cartilage tissue resulting from bodily wear and tear. However, there is accumulating evidence that inflammation plays a key role in the pathogenesis of OA. In knee OA, the most common form of OA, exercise therapy as an effective component of early treatment addresses functional deficits, pain and inflammation. Since inflammation is critical for the development and progress of OA, anti-inflammatory therapies must be combined strategically. In the course of the NUMOQUA project, an anti-inflammatory therapeutic diet named 'Austrian Osteoarthritis Cuisine' was developed. It is based on the framework of the New Nordic Diet combined with the food-based dietary guidelines of Austria, the guidelines for OA, the Austrian food culture and the principles of a sustainable diet. The present study examines the implementation of the 'Austrian OA Cuisine' combined with the evidence-based training programme GLA:D® (Good Life with osteoArthritis in Denmark) in Austrian patients with knee OA and the effects on quality of life, nutritional and inflammatory status, as well as oxidative stress parameters. Methods: A total of 60 participants aged 50 to 75 with knee OA will be included and randomly assigned either to the intervention group or the control group. All participants will undergo the GLA:D® programme in the first 6 weeks. Additionally, the intervention group will receive nutritional group training and individual nutritional counselling on the 'Austrian OA Cuisine' over 9 months. The control group will receive general information about a healthy lifestyle. Measurements at baseline and at 4 follow-up dates include nutritional, inflammatory and oxidative stress markers. Furthermore, anthropometric, behavioural and clinical data will be obtained. The recruitment process lasted from autumn 2022 to January 2024, followed by the intervention until October 2024. Discussion: The prevalence of OA is expected to increase in the future due to ongoing demographic changes and rising obesity rates. The expected results will provide important evidence on whether this interdisciplinary therapeutic approach could be a new, cost-effective and sustainable strategy to address the disease process of OA without negative side effects. Trial registration: ClinicalTrials.gov NCT05955300. Date of registration: 23rd of October 2023. [ABSTRACT FROM AUTHOR]

Background: Head and neck cancer patients undergoing concomitant chemoradiotherapy (CCRT) frequently experience loss of muscle mass and reduced functional performance. Positive effects of exercise training are reported for many cancer types but biological mechanisms need further elucidation. This randomized study investigates whether progressive resistance training (PRT) may attenuate loss of muscle mass and functional performance. Furthermore, biochemical markers and muscle biopsies will be investigated trying to link biological mechanisms to training effects.Methods: At the Departments of Oncology at Herlev and Aarhus University Hospitals, patients with stage III/IV squamous cell carcinoma of the head and neck, scheduled for CCRT are randomized 1:1 to either a 12-week PRT program or control group, both with 1 year follow-up. Planned enrollment is 72 patients, and stratification variables are study site, sex, p16-status, and body mass index. Primary endpoint is difference in change in lean body mass (LBM) after 12 weeks of PRT, assessed by dual-energy X-ray absorptiometry (DXA). The hypothesis is that 12 weeks of PRT can attenuate the loss of LBM by at least 25%. Secondary endpoints include training adherence, changes in body composition, muscle strength, functional performance, weight, adverse events, dietary intake, self-reported physical activity, quality of life, labor market affiliation, blood biochemistry, plasma cytokine concentrations, NK-cell frequency in blood, sarcomeric protein content in muscles, as well as muscle fiber type and fiber size in muscle biopsies. Muscle biopsies are optional.Discussion: This randomized study investigates the impact of a 12-week progressive resistance training program on lean body mass and several other physiological endpoints, as well as impact on adverse events and quality of life. Furthermore, a translational approach is integrated with extensive biological sampling and exploration into cytokines and mechanisms involved. The current paper discusses decisions and methods behind exercise in head and neck cancer patients undergoing concomitant chemoradiotherapy.Trial Registration: Approved by the Regional Ethics Committee for the Capital Region of Denmark (protocol id: H-15003725) and registered retrospectively at ClinicalTrials.gov ( NCT02557529 ) September 11th 2015. [ABSTRACT FROM AUTHOR]

Background: Out-of-hours (OOH) health care for acute medical problems is often challenged by long waiting time for callers in need of advice and triage. Allowing patients to bypass the OOH telephone waiting line may increase patient satisfaction and provide them with a feeling of safety. We aimed to develop an "emergency access button" enabling patients to bypass the normal telephone waiting line in out-of-hours primary care (OOH-PC) if they perceive their condition to be critical and to evaluate the effect of introducing the button in terms of patient satisfaction and their feeling of safety.Methods: All patients calling the OOH-PC in two different Danish health care regions during three months will be included in this randomized controlled trial. Data will be collected through two questionnaires developed for this study: a pop-up questionnaire on the relevance of bypassing the normal waiting line to be completed by triage professionals after patient contact and a paper/electronic questionnaire on perceived safety and satisfaction with the emergency access button to be completed by the callers. These questionnaires were developed and validated using external and internal expert feedback, focus group interviews and a two-week field test. The study will be conducted over three months with an estimated user-rate of the emergency access button of 3%.Discussion: We have developed an emergency access button and we now want to investigate whether this new option will influence upon the level of satisfaction and the feeling of safety in the calling patients. Additionally, the study will reveal the assessed relevance of the decision to bypass the line by triage professionals.Trial Registration: Registered as NCT02572115 at Clinicaltrials.gov on October 5th 2015. [ABSTRACT FROM AUTHOR]

Background: Pregnant women with depression and/or anxiety prior to pregnancy are at higher risk of preterm birth, breastfeeding problems, postpartum depression, and disruption of the mother-infant attachment. It is well documented that exercise improves psychological well-being in nonpregnant subjects with symptoms of depression. However, in only a few small studies have researchers examined the effect of exercise on symptoms of depression among pregnant women. We hypothesize that physiotherapist-supervised group exercise for pregnant women at risk of antenatal depression increases their psychological well-being. This paper describes the study protocol of a randomized controlled trial (RCT) on a supervised group exercise intervention for pregnant women with a current or previous history of depression and/or anxiety.Methods/design: The RCT is being carried out at the Department of Obstetrics, Rigshospitalet, Copenhagen University Hospital, in the period 2016-2019. The inclusion criteria are pregnant women ≥18 years of age with depression and/or anxiety requiring treatment by a psychiatrist or a psychologist within the last 10 years and/or intake of antidepressants in the 3 months prior to conception and/or during pregnancy. The women must have appropriate Danish language skills, be pregnant with a single fetus, give written informed consent, and be at 17-22 gestational weeks when the intervention begins. The primary outcome is psychological well-being (the five-item World Health Organization Well-being Index). Secondary outcomes are symptoms of depression (Edinburgh Postnatal Depression Scale), functional ability (General Health Questionnaire), clinical symptoms of anxiety (State-Trait Anxiety Inventory), sleep quality and sleep disturbances (Pittsburgh Sleep Quality Index), and pregnancy and delivery outcomes. The intervention is supervised group exercise twice weekly for 12 weeks. The control group will receive standard antenatal care. On the basis of sample size calculation, a total of 300 women will be randomly assigned to either the intervention or the control group in a ratio of 1:1.Discussion: The trial is expected to contribute to the body of knowledge used in planning antenatal care for pregnant women at risk of depression.Trial Registration: ClinicalTrials.gov, NCT02833519 . Registered on 19 May 2016. [ABSTRACT FROM AUTHOR]

Background:The main treatment for non-metastatic rectal cancer (RC) is surgical resection. Late adverse effects that are highly prevalent and negatively impact patients’ symptom burden and quality of life are: bowel-, urological and sexual dysfunctions; psychological distress; fear of recurrence. Patients and clinicians have requested a more patient-centred follow-up, balancing the focus on detection of recurrence, and physiological and psychological late adverse effects. The current follow-up program primarily focuses on detection of recurrence, with less attention on late adverse effects. As a consequence, the randomized controlled trial Follow-up after Rectal Cancer (FURCA) has been launched, testing the effect of a new patient-led, follow-up program. The aim of this paper is to describe the methodology used in the FURCA study and to report results from the development of the patient-led, follow-up program. Adult patients, treated with curative intent for primary adenocarcinoma in the rectum are included from four Danish centers. Material and methods:Patients are randomized into an intervention group, receiving standardized education and access to self-referral to an assigned project nurse, or a control group following the current follow-up program with routine medicals. The primary outcomes are symptom burden and quality of life, measured by the Functional Assessment of Cancer Therapy – Colorectal (FACT-C) questionnaire. Other outcome and demographic data are collected as patient-reported measures and register-based data. Results from developing the intervention:The education program is based on data from two focus group interviews and the feedback from experts. An algorithm is developed in order to qualify the research nurses’ responses to patients’ self-referral. Discussion and perspectives:The results of the FURCA study will strengthen the evidence base for RC follow-up, and qualify the ongoing transformation in cancer follow-up programs. [ABSTRACT FROM AUTHOR]

Background: Most young children (0–3 years) attend formal childcare in Denmark, many of them fulltime. Yet recent reports of the quality of Danish childcare centers have shown that in more than one-third of nurseries, the interactions between caregivers and young children (0–3 years) are of "insufficient" quality, which constitutes a risk for affected children's well-being and development. Effective interventions to improve childcare providers' interactive skills are necessary. Methods: In this randomized controlled trial, we test the effectiveness of the Caregiver Interaction Profile training, which focuses on improving six core interactive skills: sensitive responsiveness, respecting children's autonomy, structuring and limit setting, verbal communication, developmental stimulation, and fostering positive peer interactions. We will recruit N = 200 childcare providers from nursery groups in Copenhagen (n = 100 training group, n = 100 waiting-list control group). Our primary outcomes are childcare providers' six interactive skills named above, observed from video-recorded interactions in the nursery groups. The secondary goal of our study is to test whether the training boosts children's social-emotional and linguistic development. To this end we aim to recruit N ≈ 500 children from participating childcare providers' nursery groups (n ≈ 250 training group, n ≈ 250 waiting-list control group). We measure social-emotional and linguistic development with various standardized questionnaires, filled out by parents and childcare providers. Discussion: If the training is effective at improving childcare providers' interactive skills, then this will be an important foundation for implementation efforts, such as offering the training as part of the educational program of childcare providers. Future research should also evaluate whether the Caregiver Interaction Profile training is effective for childcare providers of older children (3–5 years) in Danish kindergartens. Trial registration: This trial is registered at clinicaltrials.gov as "Testing the Effects of the Caregiver Interaction Profile Training on the Interactive Skills of Daycare Providers (CDP)" with registry ID NCT05654116. Registration date: 12/01/2022. [ABSTRACT FROM AUTHOR]

Background: It is currently unknown if school-based social norms interventions are effective in preventing harmful alcohol consumption and other drug use among adolescents in Denmark. This paper describes the social norms-based programme The GOOD life and the design of a cluster-randomized controlled trial to test its effectiveness.Methods/design: The intervention The GOOD life is composed of three social norms components representing three different communication channels, namely face-to-face communication (normative feedback session), print communication (posters) and interactive media (web application). The intervention period of 8 weeks is preceded and followed by data collection, with the follow-up taking place 3 months after baseline. Public schools in the Region of Southern Denmark with grades 8 and 9 are invited to participate in the study and participating schools are randomly allocated to either intervention or control schools. The aim is to recruit a total of 39 schools and a sample of 1.400 pupils for the trial. An online questionnaire is conducted to examine the use of alcohol, tobacco and marijuana as well as the perceived frequency of use among peers of their own grade, which is measured before and after the intervention. Baseline data is used to develop social norms messages which are included in the three intervention components. Primary outcomes are binge drinking (more than 5 units at one occasion) and perceived frequency of binge drinking among peers, while smoking, marijuana use and alcohol-related harm will be assessed as secondary outcomes.Discussion: The GOOD life study will provide necessary insights on descriptive and injunctive norms regarding alcohol and other drug use among Danish adolescents. In addition, it will provide new knowledge and insight on the feasibility, implementation context and effectiveness of a newly developed social norms intervention in the Danish school context.Trial Registration: Date of registration: 17 February 2016 (retrospectively registered) at Current Controlled Trials with study ID ISRCTN27491960. [ABSTRACT FROM AUTHOR]

Background: Attenuating the neurological damage occurring after out-of-hospital cardiac arrest is an ongoing research effort. This dual-centre study investigates the neuroprotective effects of the glucagon-like-peptide-1 analogue Exenatide administered within 4 hours from the return of spontaneous circulation to comatose patients resuscitated from out-of-hospital cardiac arrest.Methods/design: This pilot study will randomize a total of 120 unconscious patients with sustained return of spontaneous circulation after out-of-hospital cardiac arrest undergoing targeted temperature management in a blinded one-to-one fashion to a 6-hour and 15-minute infusion of either Exenatide or placebo. Patients are eligible for inclusion if resuscitated from cardiac arrest with randomization from 20 minutes to 240 minutes after return of spontaneous circulation. The co-primary endpoint is feasibility, defined as the initiation of treatment within the inclusion window in more than 90 % of participants, and efficacy, defined as the area under the neuron-specific enolase curve from 0 to 72 hours after admission. Secondary endpoints include all-cause mortality at 30 days and Cerebral Performance Category as well as a modified Rankin Score at 180 days. The study has been approved by the Danish National Board of Health and the local Ethics Committee and is monitored by Good Clinical Practice units. The study is currently enrolling.Discussion: This paper presents the methods and planned statistical analyses used in the GLP-1 trial and aims to minimize bias and data-driven reporting of results.Trial Registration: 1) Danish National Board of Health, EudraCT 2013-004311-45. Registered on 25 March 2014. 2) Videnskabsetisk komité C, Region Hovedstaden, No. 45728. Registered on 29 January 2014. 3) Clinicaltrial.gov, NCT02442791 . Registered on 25 of January 2015. [ABSTRACT FROM AUTHOR]

A repeated dose of an oral triptan has been shown in randomized controlled trials (RCTs) to be ineffective as a treatment for no or partial response 2 hours after initial dosing but effective as treatment for headache recurrence. In the official prescription information in the United States, the United Kingdom, and Denmark repeated dosing of all seven oral triptans are recommended for headache recurrence but some triptans are also recommended for no or partial response, a use of a triptan deemed to be not beneficial in European and Canadian migraine guidelines. In summary, not all recommendations are based on evidence from RCTs. In addition, some recommendations are ambiguous and patients need clearer instructions. An example of such a clear British instruction in a patient leaflet instruction is presented at the end of the paper. [ABSTRACT FROM AUTHOR]

Background: Integration of physical activity (PA) into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness.Methods: The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools in two municipalities in the Region of Southern Denmark were invited to participate in the study. After stratification by municipality, twelve schools were randomized to either an intervention group or a control group, comprising a total of 505 children with mean age 7.2 ± 0.3 years. The intervention was a 9-month classroom-based PA program that involved integration of PA into the math lessons delivered by the schools' math teachers. The primary study outcome was change in math achievement, measured by a 45-minute standardized math test. Secondary outcomes were change in executive function (using a modified Eriksen flanker task and the Behavior Rating Inventory of Executive Function (BRIEF) questionnaire filled out by the parents), creativity (using the Torrance Tests of Creative Thinking, TTCT), aerobic fitness (by the Andersen intermittent shuttle-run test) and body mass index. PA during math lessons and total PA (including time spent outside school) were assessed using accelerometry. Math teachers used Short Message Service (SMS)-tracking to report on compliance with the PA intervention and on their motivation for implementing PA in math lessons. Parents used SMS-tracking to register their children's PA behavior in leisure time.Discussion: The results of this randomized controlled trial are expected to provide schools and policy-makers with significant new insights into the potential of classroom-based PA to improve cognition and academic achievement in children.Trial Registration: Clinicaltrials.gov: NCT02488460 (06/29/2015). [ABSTRACT FROM AUTHOR]

Background: Infectious illnesses such as influenza and diarrhea are leading causes of absenteeism among Danish school children. Interventions in school settings addressing hand hygiene have shown to reduce the number of infectious illnesses. However, most of these studies include small populations and almost none of them are conducted as randomized controlled trials. The overall aim of the Hi Five study was to develop, implement and evaluate a multi-component school-based intervention to improve hand hygiene and well-being and to reduce the prevalence of infections among school children in intervention schools by 20% compared to control schools. This paper describes the development and the evaluation design of Hi Five. Methods/design: The Hi Five study was designed as a tree-armed cluster-randomized controlled trial. A national random sample of schools (n = 44) was randomized to one of two intervention groups (n = 29) or to a control group with no intervention (n = 15). A total of 8,438 six to fifteen-year-old school children were enrolled in the study. The Hi Five intervention consisted of three components: 1) a curriculum component 2) mandatory daily hand washing before lunch 3) extra cleaning of school toilets during the school day. Baseline data was collected from December 2011 to April 2012. The intervention period was August 2012 to June 2013. The follow-up data was collected from December 2012 to April 2013. Discussion: The Hi Five study fills a gap in international research. This large randomized multi-component school-based hand hygiene intervention is the first to include education on healthy and appropriate toilet behavior as part of the curriculum. No previous studies have involved supplementary cleaning at the school toilets as an intervention component. The study will have the added value of providing new knowledge about usability of short message service (SMS, text message) for collecting data on infectious illness and absenteeism in large study populations. [ABSTRACT FROM AUTHOR]

Background: Early and integrated specialized palliative care is often recommended but has still only been investigated in relatively few randomized clinical trials.Objective: To investigate the effect of early specialized palliative care plus standard care versus standard care on the explorative outcomes in the Danish Palliative Care Trial (DanPaCT).Methods: We conducted a randomized multicentre, parallel-group clinical trial. Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Outcomes were estimated as the differences between the intervention and the control groups in the change from baseline to the weighted mean of the 3- and 8-week follow-ups measured as areas under the curve.Results: In total, 145 patients were randomized to early specialized palliative care plus standard care versus 152 to standard care only. Early specialized palliative care had no significant effect on any of the symptoms or problems. Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05).Conclusion: In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems. However, patients in the intervention group seemed more satisfied with the health care received than those in the standard care group.Trial Registration: NCT01348048. [ABSTRACT FROM AUTHOR]

Introduction: Osteoarthritis (OA) is a common disease with high socioeconomical costs. In Denmark, standard rehabilitation (SR) consists of a combination of patient education and supervised physical exercise involving a standardized neuromuscular training program. As an evidence-based alternative, high–load (>70% 1RM) resistance training (HIRT) has shown positive rehabilitation effects in knee-OA but may not be tolerated in all patients (~25%) due to knee joint pain. However, low-load resistance training (20–40% 1RM) with concurrent partial blood-flow restriction (BFR) appears to produce effects similar to HIRT yet involving reduced joint pain during and after exercise. The aim is to examine the effect of low-load BFR training compared to SR on pain, thigh muscle mass and muscle function in adults with knee-OA. We hypothesize that 12 weeks of BFR will lead to superior improvements in pain, muscle mass and mechanical muscle function compared to SR. Methods and analysis: 90 participants diagnosed with radiographic knee-OA will be randomized to either BFR or SR twice a week for 12 weeks. BFR will consist of two selected lower limb strength exercises performed with an inflated pneumatic occlusion cuff. Intervention procedures in SR consist of a full 8 weeks GLA:D course followed by 4 weeks of team group training. Primary outcome variable is the change in KOOS-Pain subscale from baseline to 12 weeks. Secondary outcome variables are changes in pain sensitivity, functional performance, muscle mass and mechanical muscle function. Intention-to-treat and per-protocol analyses will be conducted. One-way analysis of variance will be performed to evaluate between-group changes. Pre-to-post intervention comparisons will be analyzed using a mixed linear model. Regression analysis will be performed to evaluate potential associations between selected outcome variables. [ABSTRACT FROM AUTHOR]

Objective: Compare the effectiveness of a problem-solving, individualised, home-based occupational therapy intervention (ABLE 2.0), to usual occupational therapy, on activities of daily living (ADL) ability in persons with chronic conditions. Design: A single-centre, double-blinded, randomised controlled trial with 10- and 26-week follow-up. Setting: A Danish municipality. Subjects: Persons with chronic conditions experiencing problems performing ADL tasks (n = 80). Interventions: ABLE 2.0 was compared with usual occupational therapy. Main measures: Coprimary outcomes were self-reported ADL ability (ADL-Interview Performance) and observed ADL motor ability (Assessment of Motor and Process Skills) at Week 10. Secondary outcomes were self-reported ADL ability (ADL-Interview Performance) and observed ADL motor ability (Assessment of Motor and Process Skills) at Week 26, and perceived satisfaction with ADL ability (ADL-Interview Satisfaction) and observed ADL process ability (Assessment of Motor and Process Skills) at Weeks 10 and 26. Results: In total, 78 persons were randomly assigned: 40 to usual occupational therapy and 38 to ABLE 2.0. No statistically significant nor clinically relevant difference between group mean changes in primary outcomes was identified from baseline to Week 10 (ADL-Interview Performance [−0.16; 95% CI: −0.38 to 0.06] and Assessment of Motor and Process Skills ADL motor ability [−0.1; 95% CI: −0.3 to 0.1]). At Week 26, a statistically significant and clinically relevant difference was found in Assessment of Motor and Process Skills ADL motor ability (LS mean change: −0.3; 95% CI: −0.5 to −0.1) between groups. Conclusion: ABLE 2.0 was effective in improving observed ADL motor ability at 26 weeks. [ABSTRACT FROM AUTHOR]

Background Adolescent smoking is still highly prevalent in Denmark. One in four 13-year olds indicates that they have tried to smoke, and one in four 15-year olds answer that they smoke regularly. Smoking is more prevalent in socioeconomically disadvantaged populations in Denmark as well as in most Western countries. Previous school-based programs to prevent smoking have shown contrasting results internationally. In Denmark, previous programs have shown limited or no effect. This indicates a need for developing a well-designed, comprehensive, and multicomponent intervention aimed at Danish schools with careful implementation and thorough evaluation. This paper describes X:IT, a study including 1) the development of a 3-year school-based multi-component intervention and 2) the randomized trial investigating the effect of the intervention. The study aims at reducing the prevalence of smoking among 13 to 15-year olds by 25%. Methods/design The X:IT study is based on the Theory of Triadic Influences. The theory organizes factors influencing adolescent smoking into three streams: cultural environment, social situation, and personal factors. We added a fourth stream, the community aspects. The X:IT program comprises three main components: 1) smoke-free school premises, 2) parental involvement including smoke-free dialogues and smoke-free contracts between students and parents, and 3) a curricular component. The study encompasses process- and effect-evaluations as well as health economic analyses. Ninety-four schools in 17 municipalities were randomly allocated to the intervention (51 schools) or control (43 schools) group. At baseline in September 2010, 4,468 year 7 students were eligible of which 4,167 answered the baseline questionnaire (response rate = 93.3%). Discussion The X:IT study is a large, randomized controlled trial evaluating the effect of an intervention, based on components proven to be efficient in other Nordic settings. The X:IT study directs students, their parents, and smoking prevention policies at the schools. These elements have proven to be effective tools in preventing smoking among adolescents. Program implementation is thoroughly evaluated to be able to add to the current knowledge of the importance of implementation. X:IT creates the basis for thorough effect and process evaluation, focusing on various social groups. [ABSTRACT FROM AUTHOR]

Background: Musculoskeletal disorders account for one third of the long-term absenteeism in Denmark and the number of individuals sick listed for more than four weeks is increasing. Compared to other diagnoses, patients with musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. It is a challenge to coordinate this type of intervention, and the implementation of a return-to-work (RTW)-coordinator is suggested as an effective strategy in this process. The purpose of this paper is to describe the study protocol and present a new type of intervention, where the physiotherapist both has the role as RTW-coordinator and treating the patient. Methods/design: A randomized controlled trial (RCT) is currently on-going. The RCT includes 770 patients with low back pain of minimum four weeks who are referred to an outpatient back centre. The study population consists of patients, who are sick-listed or at risk of sick-leave due to LBP. The control group is treated with usual care in a team of a physiotherapist, a chiropractor, a rheumatologist and a social worker employed at the centre. The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist, a case manager from the municipal sickness benefit office, who has the authority in the actual case concerning sickness benefit payment and contact to the patients employer/work place. The treating physiotherapist is the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days off work. Secondary outcomes are disability, pain, and quality of life. The study will follow the recommendations in CONSORT-statement in designing and reporting RCTs. Discussion: This large RCT is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the municipal sickness benefit office participating in team meetings. The study has the potential to contribute to the knowledge about how to target the challenges in the treatment of LBP. The aim is to prevent sickness absence and labour market exclusion - both on the individual level and economic costs at community level. Short term results will be available in 2014. This study is approved by the Danish Regional Ethics Committee (J.nr: H-C-2008-112) and is registered at. [ABSTRACT FROM AUTHOR]

Budesonide/formoterol maintenance and reliever therapy (Symbicort SMART®) is an effective asthma-management regime where patients use budesonide/formoterol both as maintenance treatment and as additional doses as needed to improve overall asthma control by reducing symptoms and exacerbations. The aim of this study was to determine the cost-effectiveness of the Symbicort SMART® regime in Denmark vs higher dose inhaled corticosteroid (ICS) plus reliever medication, similar dose inhaled corticosteroid/long-acting β-agonist (ICS/LABA) combination therapy plus reliever medication or higher dose of inhaled ICS/LABA combination therapy plus reliever medication. The cost-effectiveness analyses were based on effectiveness and resource utilisation data, which were prospectively collected during the treatment period in five randomised clinical trials (duration: 24 weeks, 26 weeks or 1 year). Economic analyses were conducted from both a health care sector (direct costs) and a societal perspective [total costs, i.e direct costs + indirect costs (sick leave)]. The time horizon for the economic analyses was 1 year. The effectiveness measure used was the number of avoided severe exacerbations per patient per year. Patients treated with budesonide/formoterol maintenance and reliever therapy showed statistically significant fewer severe exacerbations per patient compared with the alternative treatment regimes in all comparisons. Budesonide/formoterol maintenance and reliever therapy was a dominant treatment option when compared with higher dose ICS or higher dose ICS/LABA, i.e. it was more effective at a lower total cost. In two of the three comparisons with a similar ICS/LABA dose, Symbicort SMART® was dominant. Cost-effectiveness analyses of budesonide/formoterol maintenance and reliever therapy show that the significant reduction in the number of severe exacerbations observed in all the included clinical studies is predominately obtained at lower costs compared with alternative treatment regimes. This indicates that budesonide/formoterol maintenance and reliever therapy is a cost-effective treatment option in a Danish setting. Please cite this paper as: Wickstrøm J, Dam N, Malmberg I, Hansen BB and Lange P. Cost-effectiveness of budesonide/formoterol for maintenance and reliever asthma therapy in Denmark - Cost-effectiveness analysis based on five randomised controlled trials. The Clinical Respiratory Journal 2009; 3: 169-180. [ABSTRACT FROM AUTHOR]

Background: In many countries exercise prescriptions are used in an attempt to initiate a physically active lifestyle in sedentary populations. Previous studies have primarily evaluated low intensive exercise prescription interventions and found moderately positive effects on physical activity and aerobic fitness. In a highly intensive Danish exercise prescription scheme called 'Exercise on Prescription' (EoP) the general practitioners can prescribe EoP to sedentary patients with lifestyle diseases. The aim of this randomized trial is to assess the short- and long-term effects of the EoP scheme. Thus, the aim of this paper is to describe the randomized controlled trial designed for evaluating effectiveness of EoP, and to present results from validations of outcome measures. Methods/Design: EoP involves a 16-week supervised training intervention and five counselling sessions (health profiles). All patients referred to EoP were eligible for the trial and were offered participation during the baseline health profile. Comparisons between the EoP group and the control group were made at baseline, and after four and ten months. Physiological measures used were maximal oxygen uptake (VO2max), glycosylated haemoglobin (HbA1c), bodyweight, and BMI. Patient-reported measures used were physical activity, health-related quality of life, amount and intensity of exercise, compliance with national guidelines for physical activity, and physical fitness. The validation of the cycle ergometer test found a strong correlation between maximal work capacity and VO2max, and acceptable test-retest reliability at group level. Calibration of the HbA1c apparatus was stable over ten weeks with minimal use, and test-retest reliability was good. High agreement percents were found for test-retest reliability for the self-administered questionnaire. Discussion: The trial is designed to provide information about the effectiveness of the EoP scheme. The trial is part of a health technology assessment of EoP, which besides the effectiveness covers the patient perspective, the organization, and the health economy. All three methods validated were found useful for the EoP trial. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility and fidelity of implementing and assessing the SOFIA coordinated care program aimed at lowering mortality and increasing quality of life in patients with severe mental illness by improving somatic health care in general practice. Design: A cluster-randomised, non-blinded controlled pilot trial. Setting: General Practice in Denmark. Intervention: The SOFIA coordinated care program comprised extended structured consultations carried out by the GP, group-based training of GPs and staff, and a handbook with information on signposting patients to relevant municipal, health, and social initiatives. Patients: Persons aged 18 years or older with a diagnosis of psychotic, bipolar, or severe depressive disorder. Main outcome measures: We collected quantitative data on the delivery, recruitment and retention rates of practices and patients, and response rates of questionnaires MMQ and EQ-5D-5 L. Results: From November 2020 to March 2021, nine practices were enrolled and assigned in a 2:1 ratio to the intervention group (n = 6) or control group (n = 3). Intervention group practices included 64 patients and Control practices included 23. The extended consultations were delivered with a high level of fidelity in the general practices; however, thresholds for collecting outcome measures, and recruitment of practices and patients were not reached. Conclusion: Our findings suggest that delivering the coordinated care program in a fully powered trial in primary care is likely feasible. However, the recruitment methodology requires improvement to ensure sufficient recruitment and minimize selective inclusion. Trial registration: The date of pilot trial protocol registration was 05/11/2020, and the registration number is NCT04618250. [ABSTRACT FROM AUTHOR]

Background: Signposting to web-based interventions is becoming increasingly popular in primary care. Most resources are focused on individuals with clinical problems, but less is known about the uptake of general practice (GP) signposted web-based interventions. GPs in Denmark are responsible for scheduled preventive care during pregnancy and the child's first five years. In the "Family Well-being in General Practice" trial the web-based intervention "Resilientchild.dk" is introduced at these consultations. Resilientchild.dk is designed to improve the capacity of parents to understand the mental state of themselves, their partners, and their children. In this study we assess the uptake and use of this web-based intervention. Objective: To describe participant and practice characteristics associated with the use of a web-based psychoeducational intervention. Eligible participants were pregnant women presenting at their first antenatal assessment, usually around 6–10 gestational weeks. Methods: The study was nested in a cluster randomised trial of resilientchild.dk. We conducted a relative importance analysis, which allows for determination of the variables most strongly associated with website use. To assess the direction and magnitude of the influences of the identified variables, we applied multinomial generalized linear mixed modelling. A practice random effect allows us to account for clustering of women within practices. Results: Parity and the absence of a nurse or midwife in the practice were important factors driving a decrease in the likelihood of using resilientchild.dk. Being a student or living outside the capital city were important factors driving an increase in the likelihood of using resilientchild.dk. Conclusion: The data offer unique opportunities to assess the utilisation of a web-based mental health-promotion intervention following advice from a clinician. This study draws conclusions about which patients are likely to access similar resources and which practice characteristics encourage their use. Trial registration: Registered in clinicaltrials.gov, Trial number: NCT04129359 Date of registration: 16/10/2019 (https://clinicaltrials.gov/ct2/show/NCT04129359). [ABSTRACT FROM AUTHOR]

Background: Persistent opioid use following surgery is common especially in patients with preoperative opioid use. This study aims to determine the long‐term effect of an individualised opioid tapering plan versus standard of care in patients with a preoperative opioid use undergoing spine surgery at Aarhus University Hospital, Denmark. Methods: This is the 1‐year follow‐up of a prospective, single‐centre, randomised trial of 110 patients who underwent elective spine surgery for degenerative disease. The intervention was an individualised tapering plan at discharge and telephone counselling 1 week after discharge, compared to standard of care. Postoperative outcomes after 1 year include opioid use, reasons for opioid use and pain intensity. Results: The overall response rate to the 1‐year follow‐up questionnaire was 94% (intervention group 52/55 patients and control group 51/55 patients). Forty‐two patients (proportion = 0.81, 95% CI 0.67–0.89) in the intervention group compared to 31 (0.61, 95% CI 0.47–0.73; p =.026) patients in the control group succeeded in tapering to zero 1 year after discharge (p =.026). One patient (0.02, 95% CI 0.01–0.13) in the intervention group compared to seven patients (0.14, 95% CI 0.07–0.26) in the control group were unable to taper to their preoperative dose 1 year after discharge (p =.025). Back/neck and radicular pain intensity was similar between study groups. Conclusion: These results suggest that an individualised tapering plan at discharge combined with telephone counselling 1 week after discharge can reduce opioid use 1 year after spine surgery. [ABSTRACT FROM AUTHOR]

Background: The skeletal muscle mass decreases with age and the responsiveness of aging muscles' protein synthesis rate (MPS) to protein intake seems to deteriorate. Objective: This study investigated the impact of 12 months of protein supplementation with or without physical exercise training on the basal and postprandial MPS and the skeletal muscle metabolome of healthy older Danes (> 65 years, 29 females/37 males). Methods: Subjects were randomized to follow one of five intervention groups: (1) carbohydrate, (2) collagen protein, (3) whey protein, (4) home-based light resistance training with whey protein, and (5) center-based heavy-load resistance training with whey protein. Before and after the intervention, a tracer infusion trial was conducted to measure basal and postprandial MPS in response to intake of a cocktail consisting of 20 g whey hydrolysate + 10 g glucose. In addition, the skeletal muscle metabolome was measured using gas chromatography–mass spectrometry (GC–MS) at basal state and 4 h after the intake of the cocktail. Results: One year of daily protein or carbohydrate supplementation did not alter the basal and protein-stimulated postprandial muscle protein synthesis rate or the muscle metabolome of healthy older Danes. Basal MPS (%/h) at baseline for all subjects were 0.0034 ± 0,011 (mean ± SD). In contrast to previous studies, no difference was observed in basal MPS between males and females (p = 0.75). With the developed untargeted GC–MS methodology, it was possible to detect and tentatively annotate > 70 metabolites from the human skeletal muscle samples. Conclusion: One year of protein supplementation in comparison to an isocaloric-control supplement seems to affect neither the MPS at basal or postprandial state nor the skeletal muscle metabolome. Clinical trial registry: Number: NCT02115698, clinicaltrials.gov/ct2/show/NCT02115698. [ABSTRACT FROM AUTHOR]

Background: Exercise is recommended to protect physical health among people with severe mental illness and holds the potential to facilitate long-term recovery. An inclusive exercise community provides an opportunity for life skill training and social connectedness and may reduce the experience of loneliness and internalized stigmatization which together may improve personal recovery. Using a pragmatic randomized design, we aim to examine the effectiveness of a gym-based exercise intervention tailored to young adults in antipsychotic treatment (i.e., Vega Exercise Community) compared to usual care. It is hypothesized that the Vega Exercise Community will be superior to usual care for personal recovery at four months. Methods: The trial will be conducted at four sites in Denmark from which 400 participants, aged 18 to 35 years, who are in current treatment with antipsychotic medications for the management of schizophrenia spectrum or affective disorders, will be recruited. Participants will be randomized (2:1) to Vega Exercise Community or usual care. Vega Exercise Community includes three weekly group-based exercise sessions hosted in commercial functional training centers delivered by certified Vega instructors. After four months, participants in Vega Exercise Community will be randomized (1:1) to minimal versus extended support with regards to sustained physical activity. Data will be collected at baseline, four, six and 12 months. The primary outcome is personal recovery assessed by Questionnaire about the Process of Recovery at four months. Behavioral symptoms, health-related quality of life, metabolic health, and program costs will be evaluated to further determine the effectiveness and cost-effectiveness of the Vega Exercise Community. Finally, the quality of life and physical and mental health of the participants' primary relative will be evaluated. Discussion: The results of this trial may have important implications for health, sustained physical activity, and recovery for individuals in treatment with antipsychotics. Given the pragmatic design, positive results may readily be implemented by mental health care professionals to promote exercise as an integrated part of treatment of severe mental illness. Trial registration: Clinical Trials.gov (NCT05461885, initial registration June 29th, 2022). WHO Universal Trial Number (UTN): U1111-1271–9928. [ABSTRACT FROM AUTHOR]

Background: Prehabilitation with exercise interventions during neoadjuvant chemotherapy (NACT) is effective in reducing physical and psychosocial chemotherapy-related adverse events in patients with cancer. In preclinical studies, data also support a growth inhibitory effect of aerobic exercise on the tumour microenvironment with possible improved chemotherapy delivery but evidence in human patients is limited. The aim of the study here described is to investigate if supervised exercise with high-intensity aerobic and resistance training during NACT can improve tumour reduction in patients with breast cancer. Methods: This parallel two-armed randomized controlled trial is planned to include 120 women aged ≥ 18 years with newly diagnosed breast cancer starting standard NACT at a university hospital in Denmark (a total of 90 participants needed according to the power calculation and allowing 25% (n = 30) dropout). The participants will be randomized to usual care or supervised exercise consisting of high-intensity interval training on a stationary exercise bike and machine-based progressive resistance training offered three times a week for 24 weeks during NACT, and screening-based advice to seek counselling in case of moderate-severe psychological distress (Neo-Train program). The primary outcome is tumour size change (maximum diameter of the largest lesion in millimetre) measured by magnetic resonance imaging prior to surgery. Secondary outcomes include clinical/pathological, physical and patient-reported measures such as relative dose intensity of NACT, hospital admissions, body composition, physical fitness, muscle strength, health-related quality of life, general anxiety, depression, and biological measures such as intratumoural vascularity, tumour infiltrating lymphocytes, circulating tumour DNA and blood chemistry. Outcomes will be measured at baseline (one week before to 1–2 weeks after starting NACT), during NACT (approximately week 7, 13 and 19), pre-surgery (approximately week 21–29), at surgery (approximately week 21–30) and 3 months post-surgery (approximately 33–42 weeks from baseline). Discussion: This study will provide novel and important data on the potential benefits of supervised aerobic and resistance exercise concomitant to NACT on tumour response and the tumour microenvironment in patients with breast cancer, with potential importance for survival and risk of recurrence. If effective, our study may help increase focus of exercise as an active part of the neoadjuvant treatment strategy. Trial registration: The trial was registered at ClinicalTrials.gov (NCT04623554) on November 10, 2020. [ABSTRACT FROM AUTHOR]

The educational gap between children in out‐of‐home care and their non‐placed peers is well‐documented. However, tutoring stands out as a promising intervention to raise children's educational attainment in out‐of‐home care. This study randomized 105 children in foster care (62% girls, aged 7–15 years [M = 10.3, SD = 2.0]) to the home tutoring program Foster Caregivers as Tutors (FCT) or regular public school services (treatment as usual [TAU]). In the FCT group, the foster caregivers tutored the children for 2.5 h/week for 40 weeks. The program effect is measured in learning and developmental outcomes, including reading and math ability, learning skills, IQ, executive function, and psychosocial function. Follow‐up was 17.5 months after baseline. The results show a significant effect over time in both groups on IQ (effect size [ES] = 0.40, P < 0.001), verbal comprehension (ES = 0.29 P = 0.02) and perceptual reasoning (ES = 0.60, P < 0.001) measured by WISC IV. Neither the FCT nor TAU provided any significant academic recovery in reading and math nor progression in executive function, learning skills or psychosocial function. These findings, implications for practice and future efforts to support the schooling of children in out‐of‐home care are discussed. [ABSTRACT FROM AUTHOR]

Aim: The aim of the present study was to compare performance 5 h after a 90‐min endurance training session when either carbohydrate only or carbohydrate with added whey hydrolysate or whey isolate was ingested during the first 2 h of the recovery period. Methods: Thirteen highly trained competitive male cyclists completed three exercise and diet interventions (double‐blinded, randomized, crossover design) separated by 1 week. The 90‐min morning session (EX1) included a 60 min time‐trial (TT60). Immediately and 1 h after exercise, participants ingested either (1) 1.2 g carbohydrate∙kg−1∙h−1 (CHO), (2) 0.8 g carbohydrate∙kg−1∙h−1 + 0.4 g isolate whey protein∙kg−1∙h−1 (ISO) or (3) 0.8 g carbohydrate∙kg−1∙h−1 + 0.4 g hydrolysate whey protein∙kg−1∙h−1 (HYD). Additional intakes were identical between interventions. After 5 h of recovery, participants completed a time‐trial performance (TTP) during which a specific amount of work was performed. Blood and urine were collected throughout the day. Results: TTP did not differ significantly between dietary interventions (CHO: 43:54 ± 1:36, ISO: 46:55 ± 2:32, HYD: 44:31 ± 2:01 min). Nitrogen balance during CHO was lower than ISO (p < 0.0001) and HYD (p < 0.0001), with no difference between ISO and HYD (p = 0.317). In recovery, the area under the curve for blood glucose was higher in CHO compared to ISO and HYD. HR, VO2, RER, glucose, and lactate during EX2 were similar between interventions. Conclusion: Performance did not differ after 5 h of recovery whether carbohydrate only or isocaloric carbohydrate plus protein was ingested during the first 2 h. Correspondingly, participants were not in negative nitrogen balance in any dietary intervention. [ABSTRACT FROM AUTHOR]

Study Design: Experimental, randomised crossover study. Objectives: To investigate if three different interventions that provided plantar proprioceptive input were able to make acute improvements to the one-legged standing balance. Background: Improved balance reduces the risk of falling. Therefore, it would be interesting if it were possible to improve balance with a simple intervention. Methods: Eighteen healthy able-bodied subjects (4 males) were included in the study. Self-massage, Kinesio® tape and a custom-made insole were tested in a crossover design. The order of the interventions was randomised for each participant. The participants were asked to keep the balance on an instrumented wobbleboard. Differences between the three interventions was tested with an ANOVA with Tukey-corrected post-hoc tests. Results: The custom-made insoles improved the standing balance by nine percent compared to baseline. This difference was statically significant (p <.05). The balance was not significantly better with the insole compared to self-massage or Kinesio® tape. Conclusion: We found that an individually moulded insole improved one legged standing balance. Neither Kinesio® tape or self-massage with a massage ball on the plantar sole proved to improve balance. [ABSTRACT FROM AUTHOR]

Background: Activity and participation are critical to health and wellbeing. Limited evidence exists on how to support people with mental illness in participating in everyday activities. Aim: To investigate the effectiveness of Meaningful Activities and Recovery (MA&R), a co-led peer occupational therapy intervention focusing on activity engagement, functioning, quality of life, and personal recovery. Methods: In a statistician blinded, multicenter RCT including 139 participants from seven community and municipal mental health services in Denmark, participants were randomly assigned to 1) MA&R and standard mental health care or 2) standard mental health care. The MA&R intervention lasted 8 months and consisted of 11 group sessions, 11 individual sessions, and support to engage in activities. The primary outcome, activity engagement, was measured using Profile of Occupational Engagement in People with Severe Mental Illness (POES-S). Outcomes were measured at baseline and post-intervention follow-up. Results: Meaningful Activities and Recovery was delivered with high fidelity and 83% completed the intervention. It did not demonstrate superiority to standard mental health care, as intention-to treat analysis revealed no significant differences between the groups in activity engagement or any of the secondary outcomes. Conclusion: We did not find positive effects of MA&R, possibly because of COVID-19 and related restrictions. Fidelity assessments and adherence rates suggest that MA&R is feasible and acceptable. However, future studies should focus on refining the intervention before investigating its effectiveness. Trial registration: The trial was registered 24/05/2019 at ClinicalTrials.gov NCT03963245. [ABSTRACT FROM AUTHOR]

Background: Advance care planning supports patients to reflect on and discuss preferences for future treatment and care. Studies of the impact of advance care planning on healthcare use and healthcare costs are scarce. Aim: To determine the impact on healthcare use and costs of an advance care planning intervention across six European countries. Design: Cluster-randomised trial, registered as ISRCTN63110516, of advance care planning conversations supported by certified facilitators. Setting/participants: Patients with advanced lung or colorectal cancer from 23 hospitals in Belgium, Denmark, Italy, the Netherlands, Slovenia and the UK. Data on healthcare use were collected from hospital medical files during 12 months after inclusion. Results: Patients with a good performance status were underrepresented in the intervention group (p < 0.001). Intervention and control patients spent on average 9 versus 8 days in hospital (p = 0.07) and the average number of X-rays was 1.9 in both groups. Fewer intervention than control patients received systemic cancer treatment; 79% versus 89%, respectively (p < 0.001). Total average costs of hospital care during 12 months follow-up were €32,700 for intervention versus €40,700 for control patients (p = 0.04 with bootstrap analyses). Multivariable multilevel models showed that lower average costs of care in the intervention group related to differences between study groups in country, religion and WHO-status. No effect of the intervention on differences in costs between study groups was observed (p = 0.3). Conclusions: Lower care costs as observed in the intervention group were mainly related to patients' characteristics. A definite impact of the intervention itself could not be established. [ABSTRACT FROM AUTHOR]

Objective: To examine the factors associated with unexpectedly high rates of conversion to open label oxytocin in the CONDISOX trial of continuation versus discontinuation of oxytocin infusion during induced labour. Design: Secondary retrospective analysis of data from a prospective randomised controlled trial. Setting Nine hospitals in Denmark and one in the Netherlands between 8 April 2016 and 30 June 2020. Population or sample: 1200 women having labour induced. Methods: Analysis of outcomes by actual management. Main outcome measures: Mode of delivery and associated variables. Results: Switching to open label oxytocin (42.4% overall) was associated with nulliparity, an unripe cervix, larger babies and higher rates of delivery by caesarean section. Conclusions: In the CONDISOX trial, slow labour was associated with features suggesting a higher 'resistance to progress', often prompting the use of open‐label oxytocin infusion rather than study medication. Linked article: This article is commented on by G. J. Hofmeyr, pp. 643–644 in this issue. To view this mini commentary visit https://doi.org/10.1111/1471‐0528.17377. [ABSTRACT FROM AUTHOR]

Background: Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence on the effects of accreditation, particularly in general practice. In 2016 a mandatory accreditation scheme was initiated in Denmark, and during a 3-year period all practices, as default, should undergo accreditation according to the Danish Healthcare Quality Program. The aim of this study is primarily to evaluate the effects of a mandatory accreditation scheme.Methods/design: The study is conducted as a cluster-randomized controlled trial among 1252 practices (clusters) with 2211 general practitioners in Denmark. Practices allocated to accreditation in 2016 serve as the intervention group, and practices allocated to accreditation in 2018 serve as controls. The selected outcomes should meet the following criteria: (1) a high degree of clinical relevance; (2) the possibility to assess changes due to accreditation; (3) availability of data from registers with no self-reporting data. The primary outcome is the number of prescribed drugs in patients older than 65 years. Secondary outcomes are changes in outcomes related to other perspectives of safe medication, good clinical practice and mortality. All outcomes relate to quality indicators included in the Danish Healthcare Quality Program, which is based on general principles for accreditation.Discussion: The consequences of accreditation and standard-setting processes are generally under-researched, particularly in general practice. This is the largest study in general practice with a randomized implementation approach to evaluate the clinical effects of a nation-wide mandatory accreditation scheme in general practice.Trial Registration: ClinicalTrials.gov, NCT02762240 . Registered on 24 May 2016. [ABSTRACT FROM AUTHOR]

Excessive alcohol consumption is one of the most important lifestyle factors affecting the disease burden in the Western world. The results of treatment in daily practice are modest at best. The aim of the RESCueH programme is to develop and evaluate methods, which are as practice-near as possible, and therefore can be implemented quickly and easily in everyday clinical practice. It is the first clinical alcohol programme to be transatlantic in scope, with implementation in treatment centers located in Denmark, Germany and the US. The RESCueH programme comprises 5 randomized controlled trials, and the studies can be expected to result in (1) more patients starting treatment in specialized outpatient clinics, (2) a greater number of elderly patients being treated, (3) increased patient motivation for treatment and thus improved adherence, (4) more patients with stable positive outcomes after treatment and (5) fewer patients relapsing into harmful drinking. The aim of this paper is to discuss the rationale for the RESCueH programme, to present the studies and expected results. [ABSTRACT FROM AUTHOR]

Self-regulation is pivotal for human well-being and mental health. In this qualitative study, we followed a randomized controlled trial (RCT) and explored how a five-day residential mindfulness program in a restorative natural setting supported self-regulation among university students experiencing moderate to severe stress. Six participants were interviewed post intervention and at three months' follow-up on how they experienced the retreat. Through interpretative phenomenological analysis, four interrelated themes emerged: "supportive conditions", "attitudes of mindfulness", "connection" and "physical and psychological balance." These themes reflected the outcomes of the retreat that participants valued in stressful situations. A progression occurred during the retreat through the themes, with emphasis developing from the supportive conditions of the setting, to cultivating mindful attitudes, over connection to both self, others and nature, to changes and effects on the physical, psychological and even spiritual level. In addition, participants emphasized experiences of positive emotions, energy, calmness, meta-awareness and the feeling of being part of the web of life. In conclusion, participants' experiences with a five-day nature-based mindfulness intervention revealed a range of qualities of both physical-, psychological-, social- and spiritual nature that are supportive for self-regulation. [ABSTRACT FROM AUTHOR]

Background: Individuals with severe chronic obstructive pulmonary disease (COPD) are often at risk of undernutrition with low health-related quality of life (HRQoL). Undernutrition can worsen COPD and other comorbidities, be an independent predictor of morbidity and functional decline resulting in increased healthcare consumption and increased risk of death. Especially exacerbations and acute infections result in unintentional weight loss. The aim is to investigate the effect of an individualized nutritional intervention among individuals with severe COPD. Methods: An open-label randomized controlled trial with two parallel groups. Participants are recruited from the pulmonary outpatient clinic at the Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark, and randomly allocated to either the intervention (intervention + standard of care) or control group (standard of care). The intervention has a duration of 3 months and combines individual nutritional care with adherence support and practical tools. It contains 4 elements including an individual nutritional plan, regular contacts, adherence support, and weight diary. The primary outcome is a difference in HRQoL (EQ-5D-5L) between the intervention and control group 3 months after baseline. Difference in functional capacity (grip strength, 30-s stand chair test, and physical activity), disease-specific quality of life (COPD Assessment Test), anxiety and depression (Hospital Anxiety and Depression Scale), nutritional parameters (energy and protein intake), anthropometry (weight, body mass index, waist, hip, and upper arm circumference), body composition (total fat-free and fat mass and indices), and prognosis (exacerbations, oxygen therapy, hospital contacts, and mortality) 3 months after baseline will be included as secondary outcomes. Data will be collected through home visits at baseline and 1 and 3 months after baseline. Discussion: Currently, nutritional care is a neglected area of outpatient care among individuals with severe COPD. If this patient-centered approach can demonstrate a positive impact on HRQoL, mortality, and hospital contacts, it should be recommended as part of end-of-life care for individuals with severe COPD. Trial registration: ClinicalTrials.gov NCT04873856. Registered on May 3, 2021. [ABSTRACT FROM AUTHOR]

Stoma bag filter-related issues, such as ballooning (the bag filling with gas), remain highly prevalent among users. The full-circle filter was purposely designed to reduce ballooning through the inclusion of a unique, full-circle pre-filter. Two similar randomized crossover trials were conducted to compare the performance of the full-circle filter with a dual filter in adults with a colostomy (n = 20) or an ileostomy (n = 20). The frequency of ballooning was significantly lower with the full-circle filter versus the dual filter in participants with a colostomy (p < 0.0007) and in participants with an ileostomy (p < 0.0001). No significant differences were observed in the frequency of other issues (pancaking, odor problems, and ostomy solution discretion) between the filters. On average, participants with an ileostomy wore ostomy solutions with the full-circle filter for 3.3 h longer than ostomy solutions with the dual filter (p < 0.0001); wear-time in users with a colostomy was comparable between the filters. Considering the lack of published research on stoma bag filters and the high prevalence of filter-related issues, these data provide important information for health care practitioners who support people living with a stoma. [ABSTRACT FROM AUTHOR]

The aim of this hermeneutic-phenomenological study was to explore the perspectives of 12 patients, 17 nurses, and 4 musicians on patient-tailored live music interventions in a hemodialysis setting. Twenty-six semi-structured interviews were collected—17 with patients, 9 with nurses. Furthermore, 18 moderate participation observations, whilst 1 semi-structured group interview with 3 nurses and 3 musicians, and 13 reflective journals from musicians were collected. Within the analysis—based on Ricoeur's theory of interpretation—two overall themes emerged: (1) the inner space and (2) the participating space, followed by five subthemes: (1a) Entering a calm and enjoyable pause bubble; (1b) Resting in a thought-free state of mind; (1c) Traveling in the past and catching the moment through heartfelt music; (2a) Bringing positive changes into life; (2b) The artistic quality mediating a magnificent and beautiful experience. We found that patient-tailored live music was a meaningful break, influencing mental and physical well-being, time perception, community, work environment, and artistic approach. The artistic quality of the music was essential—together with the musicians' social awareness, empathy, and ability to interact with the patients—in creating meaningful moments for patients and staff. Overall, the music interventions were a welcome change in a predictable world of stressful routines and repetitive treatments. [ABSTRACT FROM AUTHOR]

Developing acceptable medicines for children is a complicated task. Several factors must be considered, including age, physiology, texture preference, formulation, and legal framework among others. In the development of new paediatric medicines, these factors are assessed. However, for older medicines, e.g., prednisolone, acceptability is still a challenge. This study was an open-label randomised three-arm cross-over study investigating different formulations of prednisolone (crushed tablets, whole tablets, and oral solution) in paediatric patients with asthma and asthma-like symptoms. Participants were randomised into two different formulations on two consecutive days. For each formulation, the child or caregiver was asked to evaluate acceptability using a modified five-point Wong Baker Face scale. An analysis of variance (ANOVA) model was used to test for significance. For the 41 children, included mean age was 4.7 years (SD ± 3.6), and mean weight was 21 kg (SD ± 10.8). Sixty-one percent were boys. The participants were divided accordingly into three age groups: 6 to 23 months (N = 11), 2 to 5 years (N = 14), and 6–11 years (N = 16). The overall acceptability was low, with only 23 out of 71 scores rating the treatment either 1 or 2 (32%). The ANOVA test showed a significant difference in acceptability score between crushed tablets and whole tablets (p < 0.003). The mean acceptability score for the crushed tablet was the least favourable at 3.9 compared to oral solution (3.1), oro-dispersible tablet (2.8), and whole tablets (2.4). This is problematic in long-term treatment and for the youngest children who cannot swallow tablets. The improvement of age-appropriate and acceptable formulations is necessary. [ABSTRACT FROM AUTHOR]

We do not know if the delivery of Motivational Interviewing (MI) differs across countries. In an international study targeting Elderly people with Alcohol Use Disorder, The Elderly Study, MI was part of the treatment applied. Treatment delivery was measured by means of the Motivational Interviewing Treatment Integrity code version 4 (MITI 4). Mixed effects models explored potential differences in delivery of MI between the countries. Delivery of MI differed significantly between participating countries: Denmark, Germany and the US. These findings are important to consider when comparing measures of MI integrity across studies from different cultures. [ABSTRACT FROM AUTHOR]

The Hi Five study was a three-armed cluster randomized controlled trial designed to reduce infections and improve hygiene and well-being among pupils. Participating schools (n=43)were randomized into either control (n=15) or one of two intervention groups (n=28). The intervention consisted of three components: (i) a curriculum (ii) mandatory daily hand washing before lunch (iii) extra cleaning of school toilets. The aim of this study was to evaluate the implementation and to identify challenges to program implementation. Several data sources were used, including observations of school toilets, semi-structured interviews with school coordinators (n=4), focus groups with pupils (n=6) and teachers (n=5), and questionnaires among pupils (n=5440), teachers (n=387) and school coordinators (n=28). This study indicates that the curriculum was successfully implemented at most schools, and that teachers and pupils reacted positively to this part of the intervention. However, daily hand washing before lunch seems to be difficult to implement. Overall, the implementation process was affected by several factors such as poor sanitary facilities, lack of time and prioritization and objections against the increasing tendency to place the responsibility for child-rearing tasks on schools. This study reveals the strong and weak parts of the Hi Five study and can guide program improvement. [ABSTRACT FROM AUTHOR]