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Background: Current management of mesenteric ischemia is primarily endovascular stent treatment. Typical CMI symptoms are postprandial abdominal pain, food fear, weight loss, and diarrhea. Revascularization is often necessary, as mesenteric ischemia may progress to bowel necrosis and death if left untreated. This study aims to compare the outcome using bare metal stent (BMS) or covered stent (CS) in the endovascular treatment of chronic and acute on chronic mesenteric ischemia. Methods: This is an investigator-driven, prospective, randomized, single-blinded, and single-center, national cohort study at the Copenhagen University Hospital, Denmark. A total of 98 patients with chronic mesenteric ischemia (CMI) and acute-on-chronic mesenteric ischemia (AoCMI) will be randomized to treatment with either BeSmooth BMS (Bentley Innomed GmbH) or BeGraft CS (Bentley Innomed GmbH). Randomization occurs intraoperatively after lesion crossing. Discussion: There is currently no published data from prospective controlled trials regarding the preferred type of stent used for the treatment of chronic and acute-on-chronic mesenteric ischemia. This trial will evaluate the short- and long-term outcome of BMS versus CS when treating CMI and AoCMI, as well as the benefit of a more intense postoperative surveillance program. Trial registration: ClinicalTrials.gov NCT05244629. Registered on February 8, 2022. [ABSTRACT FROM AUTHOR]

Aims: Seasonal influenza vaccination is strongly recommended in patients with heart failure (HF). The NUDGE‐FLU trial recently found two electronic behavioural nudging letter strategies – a letter highlighting potential cardiovascular benefits of vaccination and a repeated letter at day 14 –effective in increasing influenza vaccination in Denmark. The aims of this pre‐specified analysis was to further examine vaccination patterns and effects of these behavioural nudges in patients with HF including potential off‐target effects on guideline‐directed medical therapy (GDMT) use. Methods and results: The nationwide NUDGE‐FLU trial randomized 964 870 Danish citizens ≥65 years to usual care or nine different electronic nudging letter strategies. Letters were delivered through the official Danish electronic letter system. The primary endpoint was the receipt of an influenza vaccine; additional outcomes for this analysis included GDMT use. In this analysis, we also assessed influenza vaccination rates in the overall Danish HF population including those <65 years (n = 65 075). During the 2022–2023 season, influenza vaccination uptake was 71.6% in the overall Danish HF population but this varied considerably with only 44.6% uptake in those <65 years. A total of 33 109 NUDGE‐FLU participants had HF at baseline. Vaccination uptake was higher among those on higher levels of baseline GDMT (≥3 classes: 85.3% vs. ≤2 classes: 81.9%; p < 0.001). HF status did not modify the effects of the two overall successful nudging strategies on influenza vaccination uptake (cardiovascular gain‐framed letter: pinteraction = 0.37; repeated letter: pinteraction = 0.55). No effect modification was observed across GDMT use levels for the repeated letter (pinteraction = 0.88), whereas a trend towards attenuated effect among those on low levels of GDMT was observed for the cardiovascular gain‐framed letter (pinteraction = 0.07). The letters had no impact on longitudinal GDMT use. Conclusions: Approximately one in four patients with HF did not receive influenza vaccination with a pronounced implementation gap in those <65 years where less than half were vaccinated. HF status did not modify the effectiveness of cardiovascular gain‐framed and repeated electronic nudging letters in increasing influenza vaccination rates. No unintended negative effects on longitudinal GDMT use were observed. Clinical Trial Registration: ClinicalTrials.gov NCT05542004. [ABSTRACT FROM AUTHOR]

Background : Acute and chronic pancreatitis constitute a continuum of inflammatory disease of the pancreas with an increasing incidence in most high-income countries. A subset of patients with a history of pancreatitis suffer from recurrence of acute pancreatitis attacks, which accelerate disease progression towards end-stage chronic pancreatitis with loss of exocrine and endocrine function. There is currently no available prophylactic treatment for recurrent acute pancreatitis apart from removing risk factors, which is not always possible. Pain is the primary symptom of acute pancreatitis, which induces the endogenous release of opioids. This may further be potentiated by opioid administration for pain management. Increased exposure to opioids leads to potentially harmful effects on the gastrointestinal tract, including, e.g. increased sphincter tones and decreased fluid secretion, which may impair pancreatic ductal clearance and elevate the risk for new pancreatitis attacks and accelerate disease progression. Peripherally acting µ-opioid receptor antagonists (PAMORAs) have been developed to counteract the adverse effects of opioids on the gastrointestinal tract. We hypothesize that the PAMORA naldemedine will reduce the risk of new pancreatitis attacks in patients with recurrent acute pancreatitis and hence decelerate disease progression. Methods: The study is a double-blind, randomized controlled trial with allocation of patients to either 0.2 mg naldemedine daily or matching placebo for 12 months. A total of 120 outpatients will be enrolled from five specialist centres in Denmark and Sweden. The main inclusion criteria is a history of recurrent acute pancreatitis (minimum of two confirmed pancreatitis attacks). The primary endpoint is time to acute pancreatitis recurrence after randomization. Secondary outcomes include changes in quality of life, gastrointestinal symptom scores, new-onset diabetes, exocrine pancreatic insufficiency, disease severity, health care utilization, adherence to treatment, and frequency of adverse events. Exploratory outcomes are included for mechanistic linkage and include the progression of chronic pancreatitis-related findings on magnetic resonance imaging (MRI) and changes in circulating blood markers of inflammation and fibrosis. Discussion: This study investigates if naldemedine can change the natural course of pancreatitis in patients with recurrent acute pancreatitis and improve patient outcomes. Trial registration: EudraCT no. 2021–000069-34. ClinicalTrials.gov NCT04966559. Registered on July 8, 2021. [ABSTRACT FROM AUTHOR]

Background: Previous research shows that adolescents with a chronic illness have more successful transfers to adult care if their parents are involved during the transition. However, there is a lack of structured and evaluated transfer programs for parents. Our aim will be to test a comprehensive transfer program for parents of adolescents with chronic illness during the transfer from pediatric to adult care and to evaluate the program's effectiveness, acceptability, and costs. Methods: The overall design for this protocol will be a randomized controlled trial. A total of 62 dyads consisting of an adolescent (age 16.5–17.5) and at least one parent will be recruited from one of four pediatric outpatient clinics (nephrology, hepatology, neurology, or rheumatology) at Copenhagen University Hospital - Rigshospitalet, Denmark. The dyads will be randomized to receive the transfer program in addition to usual care or to receive usual care only. The program includes an informative website, bi-annual online educational events, and transfer consultations across pediatric and adult care. Outcome measures will include transition readiness, allocation of responsibility, parental uncertainty level, and transfer satisfaction. Data will be collected from participants at baseline, every 6 months until transfer, at transfer, and 3 months after transfer. The parents' acceptance of and satisfaction with the program will be explored through semi-structured interviews. Cost, barriers, and facilitators affecting future implementation will be identified in interviews with health care professionals, using the Normalization Process Theory as a framework for the process analysis. Discussion: To our knowledge, this transfer program is one of the first interventions for parents of adolescents with a chronic illness during their child's transfer to adult care. Our trial will include parental and adolescent measures allowing us to examine whether a transfer program for parents will improve transfer to adult care for both parents and adolescents. We believe that results from our trial will be helpful in forming recommendations to ensure better involvement of parents in transitional care. Trial registration: ClinicalTrials.gov NCT04969328. Retrospectively registered on 20 July 2021. [ABSTRACT FROM AUTHOR]

Multisystem functional somatic disorder is characterized by specific patterns of persistent physical symptoms with a complex biopsychosocial etiology. The disorder can lead to disability and personal suffering. Current treatment options require specialized settings, therefore patients often wait a long time to receive specific treatment. Patient education is considered important in most treatment programs, but has only been investigated sparsely as a stand-alone treatment. Pharmacological treatment is limited to tricyclic antidepressants in low doses with no antidepressant properties. Duloxetine has been found effective in single organ functional disorders. As a treatment for multisystem functional somatic disorder, duloxetine could reduce symptoms and treat comorbid anxiety and depression. It may furthermore enhance the effect of patient education through a hypothesized effect on cognitive functioning. The purpose of the EDULOX trial is to study psycho-EDUcation and duLOXetine alone and in combination. This is a nested study design. The parent trial "EDULOX1" (n = 424) will compare a patient education program with enhanced usual care in an open-labelled, randomized controlled trial. In addition to this, eligible participants will furthermore receive either duloxetine or active placebo in the nested, double-blinded, randomized controlled trial, "EDULOX2" (n = 212). Patient and clinician reported outcomes will be collected through questionnaires. The EDULOX trial may establish evidence for treatments applicable for the majority of patients with multisystem functional somatic disorder. If effective, duloxetine would be a more tolerable pharmacological treatment option that can target comorbid depression and anxiety, and potentially boost the effect of patient education. Trial registration number The study is registered at www.clinicaltrials.gov (NCT06232473) and the internal list of research projects at the Region of Central Denmark (Case number 1-16-02-305-23). Approval from the Danish Medical Research Ethics Committees (Case number: 2212291) and the Danish Medicines Agency was obtained under EudraCT Number: 2022-002780-30 and Sponsor's Protocol Code Number: 9515. [ABSTRACT FROM AUTHOR]

Background: High-dose influenza vaccines provide better protection against influenza infection than standard-dose in persons aged 65 years and above; however, in most countries, high-dose vaccines are not widely implemented. Assessing the relative effectiveness of high-dose compared to standard-dose vaccines on hospitalizations and mortality would enable more robust public health and cost-effectiveness estimates. This study aims to investigate the feasibility of conducting a pragmatic randomized clinical trial in Denmark comparing high-dose to standard-dose vaccines utilizing existing vaccination infrastructure and the Danish nationwide health registries for data collection. Methods: The DANFLU-1 trial (NCT05048589) is a pragmatic, open-label, active-controlled randomized trial randomizing Danish citizens aged 65–79 years to either high-dose quadrivalent influenza vaccine or standard-dose quadrivalent influenza vaccine. The study utilizes the infrastructure of a private vaccination provider (Danske Lægers Vaccinations Service) for recruitment, inclusion, randomization, and vaccination. All collection of baseline and follow-up data including safety monitoring is performed centrally by the Department of Cardiology at Herlev and Gentofte Hospital, Copenhagen, Denmark using the Danish nationwide health registries. The study aims to include 40,000 participants during the 2021/2022 influenza season. The primary endpoints address feasibility and include the number of participants enrolled, randomization balance, and representativeness compared to the Danish general population. Relative vaccine effectiveness will also be assessed, however, this feasibility study is not powered for clinical outcomes and may be affected by the COVID-19 pandemic. Discussion: The DANFLU-1 study is investigating the feasibility of conducting a large-scale pragmatic clinical trial in Denmark utilizing existing infrastructure and the Danish nationwide registries. This will provide valuable insight, especially for potential future fully powered vaccine trials, but also for trials wishing to investigate other interventions. Trial registration: Clinicaltrials.gov: NCT05048589, registered September 17, 2021. [ABSTRACT FROM AUTHOR]

Objectives: To compare a designated shared oral care intervention in a group of public nursing home residents with a standard oral care programme, focusing on levels of oral plaque and oral inflammation. Methods: A cluster randomized field trial was undertaken in 14 Danish public nursing homes. There were 145 participants included in the intervention group and 98 in the control group. We undertook a six‐month intervention based on the principle of situated interprofessional learning. The primary outcomes were plaque and inflammation levels measured with the mucosal plaque index (MPS); this was assessed at baseline, after three and six months (end of intervention), and at follow‐up (six months postintervention). The odds ratios (OR) and 95% confidence intervals (CI) were estimated with ordinal regression. Results: Socio‐demographic characteristics and oral health status at baseline were comparable between the two groups, with the exception of age: the intervention group were significantly younger than controls (median 82 vs 87 years). After three and six months, those receiving the shared oral care intervention had significantly lower plaque and inflammation than the control group. The adjusted ORs for a reduction in MPS were 11.8 (CI: 6.5‐21.3) and 11.0 (CI: 5.8‐20.9), respectively. At follow‐up, plaque levels and oral inflammation had approached the pre‐intervention level, with no remaining statistically significant group differences. Conclusions: The shared oral care intervention based on a situated learning perspective was effective in improving oral health among care home residents. However, after termination of the intervention, the effect quickly decreased. This confirms the challenges of achieving long‐term improvement in oral health in nursing home residents. An implementation strategy focusing on achieving changes at both organizational and individual levels with persistent attention to oral health care seem required for long‐term improvement. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effects of a group-based cognitive behavioural intervention for patients with persistent low back pain (LBP) and psychological risk factors referred to secondary care. Design: A randomised controlled trial. Setting: Silkeborg Regional Hospital, Denmark. Subjects: A total of 136 participants with chronic LBP and psychological risk factors. Interventions: Participants were randomised to the standard care group, including examination by a rheumatologist and/or a physiotherapist, or the intervention group, including standard care plus a multidisciplinary group-based pain management programme. Main measures: Patient-reported outcomes were collected at baseline and after 6 and 12 months. The primary outcome was disability (Roland Morris Disability Questionnaire). Secondary outcomes included low back pain intensity, pain catastrophising, health-related quality of life, and sick leave. Results: Among 136 participants, 68 (mean age: 41.7 years (SD 11.8)) were randomised to standard care and 68 (mean age: 46.0 years (SD 10.8)) were randomised to the intervention group. Except for age, baseline characteristics were comparable between groups. 12-month follow-up was completed by 92.6% in the intervention group and 80.9% in the standard care group. Both groups achieved significant improvements on disability, with a reduction of −4.8 points (SD 6.1) in the intervention group compared to −3.7 points (SD 5.2), resulting in an insignificant difference between groups. No significant differences were found in the secondary outcomes. Conclusion: A group-based pain management programme was no more effective than standard care for patients with persistent LBP and psychological risk factors. [ABSTRACT FROM AUTHOR]

Background: Previous studies have shown that multicomponent interventions may improve meal frequency and eating habits in children, but evidence among young people is limited. This study evaluated the effect of the Healthy High School (HHS) intervention on daily intake of breakfast, lunch, water, fruit, and vegetables at 9-month follow-up. Methods: The study included first-year students (≈16 years) attending high school in Denmark. Participating schools were randomized into the HHS intervention (N = 15) or control group (operating as usual) (N = 15). The intervention was designed to promote well-being (primary outcome) by focusing on healthy habits including meals, stress prevention, and strong peer relations. It included a curriculum, structural and organisational initiatives, a workshop, and a smartphone application. Students completed self-administered online questionnaires at the beginning of the school year and nine months later. To account for clustering of data, we used multilevel logistic regression analyses to estimate odds ratios (OR). We applied an intention-to-treat approach with multiple imputations of missing data. Results: At baseline 4577 of 5201 students answered the questionnaire and 4512 at follow-up. In both groups the proportion of students eating breakfast decreased from approximately 50% to 40% from baseline to follow-up, and lunch frequency decreased from approximately 50% to 47%. Daily water intake, intake of fresh fruit and intake of vegetables remained unchanged from baseline to follow-up. There were no significant between group differences on any of the outcomes at first follow-up: breakfast: OR = 0.85 (95% CI: 0.65;1.10), lunch: OR = 0.96 (95% CI: 0.75;1.22), water intake: OR = 1.14 (95% CI: 0.92;1.40), intake of fresh fruit: (OR = 1.07, 95% CI: 0.84;1.37), vegetables: (OR = 1.01, 95% CI: 0.77;1.33). Conclusion: No evidence of an effect of the HHS intervention was found for any of the outcomes. Future studies are warranted to explore how health promoting interventions can be integrated in further education to support educational goals. Moreover, how to fit interventions to the lives and wishes of young people, by also including systems outside of the school setting. Trial registration: ISRCTN, ISRCTN43284296. Registered 28 April 2017 - retrospectively registered. [ABSTRACT FROM AUTHOR]

Background Hydration therapy is essential in the care of the older patient. Subcutaneous (SC) hydration is a relevant method for parenteral hydration, but clinical trials on the subject have methodological shortcomings compared to updated standards. Design Assessor-blinded, non-inferiority RCT to explore if SC is a safe alternative to intravenous (IV) hydration. Participants Eligible patients were: Admitted patients 65 years or older with a need for parenteral hydration. The targeted sample size was 67 patients in each group. Intervention Patients were randomised to parenteral hydration via an IV or SC catheter during a 24 hours observation period. The non-randomised catheter (inactive) was placed as a sham on the patient, thereby blinding the caregivers and outcome assessors. Measurement Our primary outcome was the proportion of patients reporting at least one adverse effect with a non-inferiority calculation using a 20% margin. Results We included 51 patients, with 24 randomised to SC and 27 to IV. We were unable to reach our target sample size due to challenges in recruitment, time limitation, and COVID-19. For the outcome of adverse effects, SC was non-inferior to IV (p = 0.012). Time spent on inserting the catheters was shorter with SC (p = 0.001). The groups did not differ by pain of insertion, discomfort during infusion, or the risk of developing delirium. Conclusion SC is a safe alternative to IV hydration, is faster to place and should be an available method for parenteral hydration wherever older adults are cared for. Trial registration ClinicalTrials.gov Identifier: NCT03710408 [ABSTRACT FROM AUTHOR]

Background: Health anxiety is common, disabling and costly due to patients' extensive use of health care services. Internet-delivered treatment may overcome barriers of accessibility to specialized treatment. We aimed to evaluate the efficacy of internet-delivered acceptance and commitment therapy (iACT). Methods: A randomized, controlled trial of iACT versus an internet-delivered discussion forum (iFORUM), performed in a Danish university hospital setting. Patients self-referred and underwent video-diagnostic assessment. Eligible patients (≥18 years) with health anxiety were randomized to 12 weeks of intervention. The randomization was blinded for the assessor. The primary outcome was between-group unadjusted mean differences in health anxiety symptoms measured by the Whiteley-7 Index (WI-7, range 0–100) from baseline to 6-month follow-up (6-MFU) using intention to treat and a linear mixed model. The study is registered at clinicaltrials.gov, number NCT02735434. Results: A total of 151 patients self-referred, and 101 patients were randomized to iACT (n = 53) or iFORUM (n = 48). A mean difference in change over time of 19.0 points [95% confidence interval (CI) 10.8–27.2, p < 0.001] was shown on the WI-7, and a large standardized effect size of d = 0.80 (95% CI 0.38–1.23) at 6-MFU. The number needed to treat was 2.8 (95% CI 1.8–6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00–4.70, p = 0.050). Adverse events were few and insignificant. Conclusions: iACT for health anxiety led to sustained effects at 6-MFU. The study contributes to the development of easily accessible treatment options and deserves wider application. [ABSTRACT FROM AUTHOR]

Background: Early integration of palliative care into oncology treatment is widely recommended. Palliative rehabilitation has been suggested as a paradigm which integrates enablement, self-management, and self-care into the holistic model of palliative care. Aim: We hypothesized that early integration of palliative rehabilitation could improve quality of life. Design: The Pal-Rehab study (ClinicalTrials.gov NCT02332317) was a randomized controlled trial. The 12-week intervention offered by a specialized palliative care team was two mandatory consultations and the opportunity of participating in an interdisciplinary group program. Supplementary individual consultations were offered, if needed. Setting/participants: At Vejle University Hospital, Denmark, adults diagnosed with advanced cancer within the last 8 weeks were randomized 1:1 to standard oncology care or standard care plus intervention. Assessments at baseline and after six and 12 weeks were based on the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). At baseline participants were asked to choose a "primary problem" from a list of QLQ-C30 domains. The primary endpoint was the change in that "primary problem" measured as area under the curve across 12 weeks (T -scores, European mean value = 50, SD = 10). Results: In all, 288 were randomized of whom 279 were included in the modified intention-to-treat analysis (146 in the standard care group and 133 in the intervention group). The between-group difference for the primary outcome was 3.0 (95% CI [0.0–6.0]; p = 0.047) favoring the intervention. Conclusion: Early integration of palliative rehabilitation into standard oncology treatment improved quality of life for newly diagnosed advanced cancer patients. Trial registration: Clinicaltrials.gov Identifier: NCT02332317, registered on December 30, 2014. [ABSTRACT FROM AUTHOR]

Background: Alcohol and other drug use disorders contribute substantially to the global burden of illness. The majority of people with substance use disorders do not receive any treatment for their problems, and developing treatments that are attractive and effective to patients should be a priority. However, whether treatment is best delivered in a group format or an individual format has only been studied to a very limited degree. The COMDAT (Combined Drug and Alcohol Treatment) trial evaluates the feasibility, acceptability, and cost effectiveness of MOVE group (MOVE-G) treatment versus MOVE individual (MOVE-I) treatment in four community-based outpatient treatment centres in Denmark.Methods: A two-arm non-inferiority trial comparing MOVE-I (Pedersen et al., Drug Alcohol Depend 218:108363, 2020) with MOVE-G a combined group treatment for both alcohol use disorder and drug use disorder. The primary objective is to examine whether MOVE-G is non-inferior to MOVE-I in relation to abstinence from drug and/or alcohol, number of sessions received, and completion of treatment as planned. All participants will receive treatment based on cognitive behavioral therapy and motivational interviewing, vouchers for attendance and text reminders, as well as medication as needed (MOVE). Participants (n = 300) will be recruited over a one-year period at four public treatment centers in four Danish municipalities. A short screening will determine eligibility and randomization status. Hereafter, participants will be randomized to the two treatment arms. A thorough baseline assessment will be conducted approximately 1 week after randomization. Follow-up assessments will be conducted at 9 months post-randomization. In addition, patients' use of drugs and alcohol, and patients' wellbeing will be measured in all sessions. The main outcome measures are drug and alcohol intake at 9 months follow-up, number of sessions attended, and dropout from treatment.Discussion: The present study will examine the potential and efficacy of combined groups (patients with alcohol and drug disorders in the same group) versus individually based treatment both based on the treatment method MOVE (Pedersen et al., Drug Alcohol Depend 218:108363, 2020).Trial Registration: ISRCTN88025085 , registration date 30/06/2020. [ABSTRACT FROM AUTHOR]

Background: Traumatic full-thickness rotator cuff tears are typically managed surgically, followed by rehabilitation, but the load progression to reach an optimal clinical outcome during postoperative rehabilitation is unknown. Purpose: To evaluate whether there was a superior effect of 12 weeks of progressive active exercise therapy on shoulder function, pain, and quality of life compared with usual care. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with surgically repaired traumatic full-thickness rotator cuff tears were recruited from 2 orthopaedic departments and randomized to progressive active exercise therapy (PR) or limited passive exercise therapy (UC [usual care]). The primary outcome was the change in the Western Ontario Rotator Cuff Index (WORC) score between groups from before surgery to 12 weeks after surgery. Secondary outcomes included changes in the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score, pain, range of motion, and strength. Adverse events were registered during the intervention period. Results: A total of 82 patients were randomized to the PR (n = 41) or UC (n = 41) group. All 82 patients (100%) participated in the 12-week assessment and 79 in the 1-year follow-up. At 12 weeks, there was no significant difference between the groups in the change in the WORC score from baseline adjusted for age, sex, and center (physical symptoms: P =.834; sports and recreation: P =.723; work: P =.541; lifestyle: P =.508; emotions: P =.568). Additionally, there was no between-group difference for the secondary outcomes including the WORC score at 1 year and the DASH score, pain, range of motion, and strength at 12 weeks and 1 year. Both groups showed significant improvements over time in all outcomes. In total, there were 13 retears (16%) at 1-year follow-up: 6 in the PR group and 7 in the UC group. Conclusion: PR did not result in superior patient-reported and objective outcomes compared with UC at either short- or long-term follow-up (12 weeks and 1 year). Registration: NCT02969135 (ClinicalTrials.gov identifier) [ABSTRACT FROM AUTHOR]

Background: Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults. Purpose: To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol–5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months. Results: At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, –7.22 to 7.45]; P =.98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, –5.03 [95% CI, −10.40 to −0.03]; P =.049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89]; P =.026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%). Conclusion: Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group. Registration: NCT01623843 (ClinicalTrials.gov identifier) [ABSTRACT FROM AUTHOR]

The adoption of the randomised controlled trial within public health research to test behavioural and lifestyle interventions means that trial researchers are increasingly expected to balance ambitions of methodological rigour and social relevance in the performance of a trial. Striking this balance is particularly important when it comes to the issue of participant compliance. This article draws from fieldwork among researchers in an exercise trial in Denmark to explore the work entailed in achieving and measuring participant compliance from a distance. By drawing on perspectives from surveillance studies, we focus on the practices, technologies and forms of knowing involved in aligning participant's bodies and practices with specific data production ambitions. The analysis highlights the work and challenges entailed in retaining participants within the scope of the researchers' monitoring. In conclusion, we suggest that the firm commitment to produce quantitative data on compliance elides the work, challenges and collaborative practices entailed in achieving compliance and highlighting the challenges of ensuring compliance. The article describes the randomised controlled trial, not as a powerful governmental socio-technical apparatus, but as a fragile, situated, and fundamentally challenged surveillance system. This has important implications for ambitions to consider the complexity of behavioural interventions. [ABSTRACT FROM AUTHOR]

Parental competence and child functioning may be enhanced through behavioral parent training (BPT). However, conducting BPT is associated with substantial costs, and availability is often limited. This study assesses the cost-effectiveness of a BPT program in Denmark, Caring in Chaos (CiC), delivered by skilled volunteers (CiC trainers). Parents of three-nine-year-old children with ADHD or similar difficulties were recruited and randomized into treatment (n = 80 children, N = 160 parents) or waitlist control (n = 81 children, N = 162 parents). Parenting competence and child functioning were assessed using the Parenting Sense of Competence Scale (PSOC) and the Home Situations Questionnaire (HSQ) at baseline and four-month follow-up. Costs for providers included non-recurrent costs, set-up costs, and running costs, and costs for participants were assessed by time use. The total recurrent cost per family is $1,178 (PPP adjusted, 2015) (8,601 DKK, 2015), and the average time use by families is 34.96 h (SD = 11.55). From a provider perspective, CiC is cost effective with a 90% probability, if providers are willing to pay $2,230 (16,287 DKK) or $5,579 (40,744 DKK) per SD gain in PSOC or HSQ, respectively. From a participant perspective, CiC is time effective with a 90% probability, if participants are willing to spend 67 or 165 h per SD gain in PSOC or HSQ, respectively. Overall, our findings suggest that the cost-effectiveness of volunteer-delivered BPT, such as CiC, compares favorably with the cost-effectiveness of BPT programs delivered by professionals. Highlights: Skilled volunteers may be a cost-effective alternative to delivering behavioral parent training. The probability of cost-effectiveness is highest for parental competences. Future studies would benefit from including instruments that allow for the estimation of QALYs. [ABSTRACT FROM AUTHOR]

Objectives: In Denmark, 25% of hospital admissions with stroke are recurrent strokes. With thrombolytic treatment, more patients survive with only minor disability. This promising development should be followed up by intensive secondary prevention. Hypertension is the most important target. We aimed at testing the hypotheses that early follow‐up in a preventive clinic would result in (a) a higher proportion of patients with blood pressure at target and (b) time to stroke recurrence, myocardial infarction, and death would be longer in the intervention group compared to controls. Materials and Methods: Eligible patients admitted to the stroke unit of Herlev Hospital were randomized shortly before discharge to intervention or control group. Of 78 included participants, data from 73 were available for follow‐up 9 months after inclusion. Patients in the intervention group were seen in the clinic within 1 week. In case of hypertension, treatment was initiated or supplied with a new drug. We used individual targets for blood pressure according to diagnosis of stroke and patients' comorbidity. Patients in the intervention group had a median of five visits to the preventive clinic. Results: In the intervention group, blood pressure was treated to target in 25 patients (69%) versus 14 (38%) in the control group (p =.007). Median time to first event was 44 months (4–49) in the intervention group and 19 months (4–37) in controls (p =.316). Conclusions: Treatment of hypertension to individual targets after stroke is feasible. It may postpone recurrent stroke and death in stroke survivors. [ABSTRACT FROM AUTHOR]

Background: Being homeless entails higher mortality, morbidity, and prevalence of psychiatric diseases. This leads to more frequent and expensive use of health care services. Medical respite care enables an opportunity to recuperate after a hospitalization and has shown a positive effect on readmissions, but little is known about the cost-effectiveness of medical respite care for homeless people discharged from acute hospitalization. Therefore, the aim of the present study was to investigate the cost-effectiveness of a 2-week stay in post-hospital medical respite care.Methods: A randomized controlled trial and cost-utility analysis, from a societal perspective, was conducted between April 2014 and March 2016. Homeless people aged > 18 years with an acute admission were included from 10 different hospitals in the Capital Region of Denmark. The intervention group (n = 53) was offered a 2-week medical respite care stay at a Red Cross facility and the control group (n = 43) was discharged without any extra help (usual care), but with the opportunity to seek help in shelters and from street nurses and doctors in the municipalities. The primary outcome was the difference in health care costs 3 months following inclusion in the study. Secondary outcomes were change in health-related quality of life and health care costs 6 months following inclusion in the study. Data were collected through Danish registries, financial management systems in the municipalities and at the Red Cross, and by using the EQ-5D questionnaire.Results: After 3 and 6 months, the intervention group had €4761 (p = 0.10) and €8515 (p = 0.04) lower costs than the control group, respectively. Crude costs at 3 months were €8448 and €13,553 for the intervention and control group respectively. The higher costs in the control group were mainly related to acute admissions. Both groups had minor quality-adjusted life year gains.Conclusions: This is the first randomized controlled trial to investigate the cost-effectiveness of a 2-week medical respite care stay for homeless people after hospitalization. The study showed that the intervention is cost-effective. Furthermore, this study illustrates that it is possible to perform research with satisfying follow-up with a target group that is hard to reach.Trial Registration: ClinicalTrials.gov Identifier: NCT02649595. [ABSTRACT FROM AUTHOR]

Introduction: Vitamin D deficiency is common in pregnancy, especially in obese women. Lifestyle intervention could potentially result in higher levels of vitamin D. We therefore aimed to study the effect of lifestyle intervention during pregnancy on serum levels of 25-hydroxyvitamin D (25(OH)D).Material and Methods: A total of 360 obese women were randomized before gestational age 14 weeks to lifestyle intervention (diet and exercise) or routine clinical follow up (controls). Clinical outcomes and levels of 25(OH)D were determined three times: At gestational age 12-15 weeks (baseline), gestational age 28-30 weeks and 6 months postpartum.Results: A total of 304 (84%) women completed the intervention study and 238 (66%) attended postpartum follow up. Vitamin D levels were similar in the two groups at baseline. At gestational age 28-30 weeks and 6 months postpartum, 25(OH)D levels were significantly higher in the intervention group than in controls (75.6 vs 66.8 nmol/L, P = 0.009) and (54.8 vs 43.1 nmol/L, P = 0.013), respectively. Concurrently, vitamin D deficiency (25-hydroxyvitamin D <50 nmol/L) was less frequent in the intervention group than in controls: 15 vs 25% (P = 0.038) at gestational age 28-30 and 45 vs 63% (P = 0.011) 6 months postpartum, respectively.Conclusions: Lifestyle intervention during pregnancy was associated with significantly increased vitamin D levels in late pregnancy and postpartum compared with controls. [ABSTRACT FROM AUTHOR]

Objective: To assess if a higher dose of exercise training in exercise-based cardiac rehabilitation could affect improvements in aerobic capacity and muscle strength. Design: Assessor-blinded randomized controlled trial with 12-months follow-up. Setting: Aarhus University Hospital, Aarhus, Denmark. Subjects: A total of 164 cardiac patients referred to exercise-based cardiac rehabilitation were recruited. Interventions: Patients were randomized to 1-hour exercise sessions either three times weekly for 12 weeks (36 sessions, high-dose group) or twice weekly for 8 weeks (16 sessions, low-dose group). The same standardized exercise and intensity protocol including aerobic and muscle strength training was used in all participants. Main measures: Primary outcome was changes in VO2peak. Secondary outcomes were changes in maximal workload, muscle strength and power. Measures were obtained at baseline, after termination of the rehabilitation programme and at follow-up after 6 and 12 months. Results: After the end of intervention, statistically significant between-group differences were seen in favour of the high-dose group in all outcomes: VO2peak 2.6 (mL kg−1 min−1) (95% confidence interval (CI): 0.4–4.8), maximal workload 0.3 W kg−1 (95%CI: 0.02–0.5), isometric muscle strength 0.7 N m kg−1 (95%CI: 0.1–1.2) and muscle power 0.3 W kg−1 (95%CI: 0.04–0.6). After 12 months, a significant between-group difference only persisted in VO2peak and maximal workload. Conclusion: A higher dose of exercise training had a small effect on all outcomes at termination of intervention. A long-term effect persisted in VO2peak and maximal workload. Although the effect was small, it is an important finding because VO2peak is the most important predictor of all-cause mortality in cardiac patients. [ABSTRACT FROM AUTHOR]

Background: Models of collaborative care and consultation liaison propose organizational changes to improve the quality of care for people with common mental disorders, such as anxiety and depression. Some literature suggests only short-term positive effects of consultation liaison on patient-related outcomes, whereas collaborative care demonstrates both short-term and long-term positive effects. To our knowledge, only one randomized trial has compared the effects of these models. Collaborative care was superior to consultation liaison in reducing symptoms of depression for up to 3 months, but the authors found no difference at 9-months' follow-up. The Collabri Flex Trial for Depression and the Collabri Flex Trial for Anxiety aim to compare the effects of collaborative care with those of a form of consultation liaison that contains potential contaminating elements from collaborative care. The trials build on knowledge from the previous cluster-randomized Collabri trials.Methods: Two randomized, investigator-initiated, parallel-group, superiority trials have been established: one investigating the effects of collaborative care vs consultation liaison for depression and one investigating the effects of collaborative care vs consultation liaison for generalized anxiety, panic disorder and social anxiety disorder at 6-months' follow-up. Participants are recruited from general practices in the Capital Region of Denmark: 240 in the depression trial and 284 in the anxiety trial. The primary outcome is self-reported depression symptoms (Beck Depression Inventory (BDI-II)) in the depression trial and self-reported anxiety symptoms (Beck Anxiety Inventory (BAI)) in the anxiety trial. In both trials, the self-reported secondary outcomes are general psychological problems and symptoms (Symptom Checklist 90-Revised), functional impairment (Sheehan Disability Scale) and general well-being (World Health Organization-Five Well-Being Index). In the depression trial, BAI is an additional secondary outcome, and BDI-II is an additional secondary outcome in the anxiety trial. Explorative outcomes will also be collected.Discussion: The results will supplement those of the cluster-randomized Collabri trials and provide pivotal information about the effects of collaborative care in Denmark.Trial Registration: ClinicalTrials.gov, NCT03113175 and NCT03113201 . Registered on 13 April 2017. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to test and compare the effect of (1) a systematic discharge assessment with targeted advice and (2) a motivational interview followed by a home visit. Design: This was a three-armed randomized controlled study. Setting: This study was conducted in the Medical department in a university hospital. Subjects: Patients ⩾65 years of age with health problems at discharge participated in the study. Interventions: Group A (n = 117): patients were informed of health problems and self-care interventions; Group B (n = 116): a motivational conversation targeting activities of daily living with a home care nurse and a home visit. Main measures: The main measures of this study were readmissions, handgrip strength, chair-to-stand test, health-related quality of life, depression signs, mortality, and call on municipality services. Results: Risk of readmission was reduced for intervention groups by 30% (A; P = 0.26) and 22 % (B; P = 0.46). Mean number of days to first readmission was 49.5 (±51.0) days for the control group (n = 116) and 57.9 (±53.6) and 67.2 (±58.1) days for the intervention groups A (P = 0.43) and B (P = 0.10), respectively. Mean loss of handgrip strength was 10.6 (±16.6) kg for men in the control group and 7 (±19.2) and 1.4 (±17.1) kg for the intervention groups A (P = 0.38) and B (P = 0.01), respectively. Health-related quality of life improved with 0.3 (±23.7) points in the control group and 7.4 (±24.4) and 3.2 (±22.3) points in the intervention groups A (P = 0.04) and B (P = 0.37), respectively. In total, 17 (16.3%) in the control group were provided with assistive devices after three months and 8 (7.3%) and 19 (17.6%) in the intervention groups A (P = 0.04) and B (P = 0.81), respectively. Conclusion: The interventions reduced the risk of readmission and improved handgrip strength, quality of life, and use of assistive devices. [ABSTRACT FROM AUTHOR]

Compression stockings reduce the risk of thromboembolic complications, leg edema, and edema-related pain and discomfort during long-haul flights. The aim of this study was to assess if compression stockings reduce leg edema, pain, and discomfort during a three-hour flight. This randomized controlled trial had a paired design as participants were randomized to wear a compression stocking on one leg during a three-hour flight with the other leg acting as control. Eligibility criteria were adults aged 18–60 years living in Denmark without medical indication for wearing compression stockings during flights. The primary outcome was the change in difference of ankle circumference between legs with and without compression stocking pre- and post-flight. Secondary outcomes were changes in difference of calf circumference, pain, and discomfort pre- and post-flight. All outcomes were self-reported with measurements and questionnaires. A total of 34 participants, median age 31 years (range 25–54), were randomized with complete follow-up. Difference in ankle circumference was median 5 mm larger post-flight compared with pre-flight (interquartile range (IQR) = 0–9, p =.001) and the corresponding change in calf circumference difference was median 5 mm (IQR = 1–12, p <.001). Ankle- and calf circumferences decreased in the leg wearing compression stocking and increased in the other leg. There was no change in difference of pain and discomfort and no adverse events. Compression stockings reduced edema formation in young healthy passengers during a three-hour flight. Passengers experiencing edema-related discomfort during short-haul flights may benefit from wearing compression stockings during air travel. Trial registration : clinicaltrials.gov : NCT03546725. • Compression stockings reduced ankle- and calf edema during a short-haul flight. • Compression stockings did not improve comfort or pain in young healthy passengers. • Use of compression stockings did not cause any adverse events. [ABSTRACT FROM AUTHOR]

Background: Low serum 25-hydroxyvitamin D [25(OH)D] has been associated with unfavorable cardiometabolic risk profiles in many observational studies in children, but very few randomized controlled trials have investigated this.Objective: We explored the effect of winter-time cholecalciferol (vitamin D3) supplementation on cardiometabolic risk markers in young, white, 4- to 8-y-old healthy Danish children (55°N) as part of the pan-European ODIN project.Methods: In the ODIN Junior double-blind, placebo-controlled, dose-response trial, 119 children (mean ± SD age: 6.7 ± 1.5 y; 36% male; 82% normal weight) were randomly allocated to 0, 10 or 20 µg/d of vitamin D3 for 20 wk (October-March). Cardiometabolic risk markers including BMI-for-age z score (BMIz), waist circumference, systolic and diastolic blood pressure, serum triglycerides and cholesterol (total, LDL, HDL, and total:HDL), plasma glucose and insulin, and whole-blood glycated hemoglobin were measured at baseline and endpoint as secondary outcomes together with serum 25(OH)D. Intervention effects were evaluated in linear regression models as between-group differences at endpoint adjusted for baseline value of the outcome, and additionally for age, sex, baseline serum 25(OH)D, BMIz, time since breakfast, and breakfast content.Results: Mean ± SD serum 25(OH)D was 56.7 ± 12.3 nmol/L at baseline and differed between groups at endpoint with concentrations of 31.1 ± 7.5, 61.8 ± 10.6, and 75.8 ± 11.5 nmol/L in the 0-, 10-, and 20 µg/d groups, respectively (P < 0.0001). Vitamin D3 supplementation had no effect on any of the cardiometabolic risk markers in analyses adjusted for baseline value of the outcome (all P ≥ 0.05), and additional covariate adjustment did not change the results notably.Conclusions: Preventing the winter decline in serum 25(OH)D with daily vitamin D3 supplementation of 10 or 20 µg had no cardiometabolic effects in healthy 4- to 8-y-old Danish children. This trial was registered at www.clinicaltrials.gov as NCT02145195. [ABSTRACT FROM AUTHOR]

Background: Epidemiologic studies have supported inverse associations between low serum 25-hydroxyvitamin D [25(OH)D] and cardiometabolic risk markers, but few randomized trials have investigated the effect of vitamin D supplementation on these markers in adolescents.Objective: The objective of this study was to investigate the effect of winter-time cholecalciferol (vitamin D3) supplementation on cardiometabolic risk markers in white, healthy 14- to 18-y-old adolescents in the UK (51°N) as part of the ODIN Project.Methods: In a dose-response trial, 110 adolescents (mean ± SD age: 15.9 ± 1.4 y; 43% male; 81% normal weight) were randomly assigned to receive 0, 10 or 20 μg/d vitamin D3 for 20 wk (October-March). Cardiometabolic risk markers including BMI-for-age z score (BMIz), waist circumference, systolic and diastolic blood pressure, fasting plasma triglycerides, cholesterol (total, HDL, LDL, and total:HDL), and glucose were measured at baseline and endpoint as secondary outcomes, together with serum 25(OH)D. Intervention effects were evaluated in linear regression models as between-group differences at endpoint, adjusted for the baseline value of the outcome variable and additionally for age, sex, Tanner stage, BMIz, and baseline serum 25(OH)D.Results: Mean ± SD baseline serum 25(OH)D was 49.1 ± 12.3 nmol/L and differed between groups at endpoint with concentrations of 30.7 ± 8.6, 56.6 ± 12.4, and 63.9 ± 10.6 nmol/L in the 0, 10, and 20 μg/d groups, respectively (P ≤ 0.001). Vitamin D3 supplementation had no effect on any of the cardiometabolic risk markers (all P > 0.05), except for lower HDL (-0.12 mmol/L; 95% CI: -0.21, 0.04 mmol/L; P = 0.003) and total cholesterol (-0.21 mmol/L; 95% CI: -0.42, 0.00 mmol/L; P = 0.05) in the 20 μg/d than in the 10 μg/d group, which disappeared in the fully adjusted analysis (P = 0.27 and P = 0.30, respectively).Conclusions: Supplementation with vitamin D3 at 10 and 20 μg/d, which increased serum 25(OH)D concentrations during the winter-time, had no effect on markers of cardiometabolic risk in healthy 14- to 18-y-old adolescents. This trial was registered at clinicaltrials.gov as NCT02150122. [ABSTRACT FROM AUTHOR]

Abstract: Background and purpose: Patients with hip osteoarthritis have impairments in muscle function (muscle strength and power) and hip range of motion (ROM), and it is commonly believed that effective clinical management of osteoarthritis should address these impairments to reduce pain and disability. Therefore, the purpose of this study was to compare the short‐ and long‐term effects of 4 months of physiotherapist‐supervised strength training, physiotherapist‐supervised Nordic Walking (NW), or unsupervised home‐based exercise (HBE) on muscle function and hip ROM in patients diagnosed with hip osteoarthritis. Methods: Secondary outcome analyses from an observer‐blinded three‐armed parallel‐design randomized controlled trial in 60+‐year‐old patients with clinical hip osteoarthritis (American College of Rheumatology criteria) who were not on a waiting list for hip replacement. One hundred and fifty‐two patients were randomized to either 4 months of physiotherapist‐supervised, moderate, progressive, strength training (n = 50), physiotherapist‐supervised NW (n = 50), or unsupervised HBE (n = 52). Maximal isometric hip and thigh muscle strength and leg extensor power and active hip ROM were assessed at baseline 2, 4, and 12 months. Results: Intention‐to‐treat‐analyses did not show any significant between‐group differences for improvements in muscle strength and power or ROM at any time points. Short‐term significant (p < .05) increases in muscle strength were present in the physiotherapist‐supervised exercise groups and in the long‐term for muscle power in the NW‐group. All exercise modes resulted in significant increases of ROM but long‐term improvements were only shown for NW and HBE. Discussion: Four months of physiotherapist‐supervised, progressive, moderate, and strength training was less effective than hypothesized for improving muscle strength and power in patients with hip osteoarthritis who are not awaiting hip replacement. Our results may indicate that in these patients, improvements in disability are not necessarily dependent on improvements in strength and power or ROM. [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: Suicidal thoughts are common, causing distress for millions of people all over the world. However, people with suicidal thoughts might not access support due to financial restraints, stigma or a lack of available treatment offers. Self-help programs provided online could overcome these barriers, and previous efforts show promising results in terms of reducing suicidal thoughts. This study aims to examine the effectiveness of an online self-help intervention in reducing suicidal thoughts among people at risk of suicide. The Danish Self-help Online against Suicidal thoughts (SOS) trial is a partial replication of a previously conducted Dutch trial.Methods and Design: A randomized, waiting-list controlled trial with 1:1 allocation ratio will be carried out. A total of 438 people with suicidal thoughts will be recruited from the Danish suicide hotline, The Lifeline's, website and allocated to the intervention condition (N = 219) or the control condition (N = 219). The intervention condition consists of a 6-week, Internet-based self-help therapy intervention. The format of the intervention is self-help, but the participants can be guided by the trial manager. The control condition consists of a waiting-list assignment for 32 weeks. The primary outcomes are frequency and intensity of suicidal thoughts. Secondary outcome measures include depressive symptoms, hopelessness, worrying, quality of life, costs related to health care utilization and production loss. Number of deliberate self-harm episodes, suicides and deaths will, as well as the participant's evaluation of the intervention and the experience of negative effects, be investigated. Assessments will be conducted over the intervention website through self-report questionnaires at baseline, 2 weeks, 4 weeks, 6 weeks and 32 weeks (6 months post intervention).Discussion: If we find the intervention to be linked to reductions in suicidal thoughts, this will strengthen the evidence that online self-help interventions are relevant tools for people with suicidal thoughts.Trial Registration: ClinicalTrials.gov, NCT02872610 . Registered on 9 August 2016. [ABSTRACT FROM AUTHOR]

Background: Nonattendance at scheduled appointments in public hospitals presents a challenge for efficient resource use and may ultimately affect health outcomes due to longer waiting times. Seven percent of all scheduled outpatient appointments in the United Kingdom are estimated to be nonattended. Various reminder systems have been shown to moderately reduce nonattendance, although the effect of issuing fines for nonattendance has not yet been tested in a randomized context. However, such use of financial incentives could impact access to care differently across the different socioeconomic groups. The aim of this study is to assess the effect of fines on hospital outpatient nonattendance.Methods/design: A 1:1 randomized controlled trial of scheduled outpatient appointments was used, with follow-ups until the date of appointment. The setting is an orthopedic clinic at a regional hospital in Denmark. Appointments for users who are scheduled for diagnostics, treatment, surgery, or follow-ups were included from May 2015 to November 2015. Appointments assigned to the intervention arm include an attachment of the appointment letter explaining that a fine will be issued in the case of nonattendance without prior notice. Appointments assigned to the control arm follow usual practice (same system but no letter attachment). The primary outcome is the proportion of nonattendance. Secondary outcomes are proportions of cancellations, sociodemographics, and health-problem characteristics. Furthermore, the intervention costs and production value of nonattended appointments will be measured. An analysis of effect and cost-effectiveness will be conducted based on a 5 % significance level.Discussion: The study is initiated and funded by the Danish Regions, which have the responsibility for the Danish public healthcare sector. The results are expected to inform future decisions about the introduction of fines for nonattendance at public hospitals.Trial Registration: Current Controlled Trials, ISRCTN61925912 . Registered on 6 July 2015. [ABSTRACT FROM AUTHOR]

Background: During the past decade an increasing number of people live with advanced cancer mainly due to improved medical treatment. Research has shown that many people with advanced cancer have problems with everyday activities, which have negative impact on their quality of life, and that they spend a considerable part of their time at home. Still, research on interventions to support the performance of and participation in everyday activities is only scarcely available. Therefore, the occupational therapy-based "Cancer Home-Life Intervention" consisting of tailored adaptive interventions applied in the participant's home environment was developed. The objective of this study is to examine the effectiveness and cost-effectiveness of the Cancer Home-Life Intervention compared to usual care on the performance of and participation in everyday activities and quality of life in people with advanced cancer living at home. Methods: The study is a randomised, controlled trial (RCT) including an economic evaluation. The required sample size of 272 adults living at home will be recruited from outpatient clinics at two Danish hospitals. They should be diagnosed with cancer; evaluated incurable by the responsible oncologist; and with a functional level 1-2 on the WHO performance scale. The primary outcome is the quality of performance of activities of daily living. Secondary outcomes are problems with prioritised everyday activities; autonomy and participation; and health-related quality of life. Participants are randomly assigned to: a) The Cancer Home-Life Intervention in addition to usual care, and b) Usual care alone. Discussion: The trial will show whether the Cancer Home-Life Intervention provides better support for people with advanced cancer living at home in performing and participating in everyday activities, and whether it contributes to their health-related quality of life. The economic evaluation alongside the RCT will show if the Cancer Home-Life Intervention is cost-effective. The trial will also show the acceptability of the intervention to the target group, and whether subgroups of participants will benefit more than others. Trial registration: ClinicalTrials.gov Identifier NCT02356627. Registered 02/02/2015. [ABSTRACT FROM AUTHOR]

Background: Central sensitization is modulated by the endogenous opioid system and plays a major role in the development and maintenance of pain. Recent animal studies performed following resolution of inflammatory pain showed reinstatement of tactile hypersensitivity induced by administration of a mu-opioid-antagonist, suggesting latent sensitization is mediated by endogenous opioids. In a recent crossover study in healthy volunteers, following resolution of a first-degree burn, 4 out of 12 volunteers developed large secondary areas of hyperalgesia areas after a naloxone infusion, while no volunteer developed significant secondary hyperalgesia after the placebo infusion. In order to consistently demonstrate latent sensitization in humans, a pain model inducing deep tissue inflammation, as used in animal studies, might be necessary. The aim of the present study is to examine whether a high-dose target-controlled naloxone infusion can reinstate pain and hyperalgesia following recovery from open groin hernia repair and thus consistently demonstrate opioid-mediated latent sensitization in humans.Methods/design: Patients submitted to unilateral, primary, open groin hernia repair will be included in this randomized, placebo-controlled, double-blind, crossover study. The experimental days take place 6-8 weeks after surgery, time-points at which patients are expected to be almost pain- free. Prior to administration of naloxone or placebo, the primary outcome (a summated measure of pain: at rest, during transition from supine to standing position, and evoked by pressure algometry) and the secondary outcomes (secondary hyperalgesia/allodynia, pressure pain thresholds, assessed at the surgical site and at the mirror-site in the contralateral groin, and, opioid withdrawal symptoms) will be assessed. These assessments will be repeated at each step of the target-controlled infusion of placebo or naloxone at estimated median (95 % CI) plasma concentrations of 344 ng/ml (130;567), 1059 ng/ml (400;1752) and 3196 ng/ml (1205;5276).Discussion: We aim to demonstrate opioid-mediated latent sensitization in a post-surgical setting, using pain as a clinical relevant variable. Impairment of the protective endogenous opioid system may play an important role in the transition from acute to chronic pain. In order to sufficiently block the endogenous opioid system, a high-dose target-controlled naloxone-infusion is used, in accordance with recent findings in animal studies.Trial Registration Number: Eudract: 2015-000793-36 (Registration date: 16 February 2015) Clinicaltrials.gov: NCT01992146 (Registration date: 12 December 2014). [ABSTRACT FROM AUTHOR]

BackgroundThe number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder.MethodA total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18–60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups.ResultsIntention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval −0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group.ConclusionsThese results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool. [ABSTRACT FROM AUTHOR]

Background: Infancy is an important period in a child's life, with rapid growth and development. Early experiences shape the developing brain, and adverse experiences can have both an immediate and lifelong impact on health and wellbeing. Parenting interventions offered to parents of newborns can support parents in providing sensitive and responsive care, and reinforce healthy development for their infants. This study aims to evaluate the impact of the Incredible Years™ Parents and Babies Program in a universal setting for parents with infants. Methods/Design: This is a pragmatic, two-arm, parallel, pilot, randomized controlled trial (RCT) where 128 families with newborn infants up to four-months-old are recruited in two municipalities in Denmark. Families are randomized to the Incredible Years Parents and Babies Program or usual care with a 2:1 allocation ratio. The primary outcome is parenting confidence measured after 20 weeks by the Karitane Parenting Confidence Scale and Parental Stress Scale. Secondary outcomes include measures of parent health, reflective functioning, relationship with the infant, and infant development. Interviewers and data analysts are blind to allocation status. Discussion: This is the first RCT of the Incredible Years Parents and Babies Program, and one of the first rigorous evaluations of a universally offered preventive intervention for parents with infants. The trial will provide important information on the effectiveness of a relatively brief, universally offered parenting intervention for parents of infants, and will also provide information on infant measures, parent recruitment and participation, and implementation of the program, which could inform future trials. [ABSTRACT FROM AUTHOR]

Objective. To evaluate the effect of two intervention modalities concerning overweight and obesity among children in general practice. Design. Prospective randomized controlled trial. Setting. A total of 60 general practices in the former County of Funen, Denmark. Subjects. Overweight children, identified by International Obesity Task Force criteria, aged 5–9 years. Intervention. Model 1 with health consultations in general practice during a two-year period or Model 2, an educational programme for the children and their families in addition to the health consultations. Main outcome measures. Change in body mass index (BMI) z-score in order to compare the results, independent of gender- and age-related changes over time. Results. A total of 80 children were recruited with 35 and 45 children allocated to Model 1 and Model 2, respectively. No significant differences were found in the change in BMI z-score (SDS) between the two groups. A decrease in the mean BMI z-score from baseline to study end of −0.20 (95%CI −0.38 to −0.01) in Model 1 and −0.26 (95%CI −0.44 to −0.09) in Model 2, respectively, was detected. The majority of the participants (2/3) continued in the study for more than one year in both models, with a mean of 12 consultations in general practice. Conclusion. In this particular setting the two intervention strategies against overweight and obesity did not differ significantly with regard to change in BMI z-scores. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives This study aimed to evaluate the relative effectiveness of electronic and postal reminders for increasing adherence to the quality assurance programme for the international normalized ratio ( INR) point-of-care testing ( POCT) device in primary care. Methods All 213 family practices that use the Elective Laboratory of the Capital Region, Denmark, and regularly conduct INR POCT were randomly allocated into two similarly sized groups. During the 4-month intervention, these practices were sent either computer reminders ( Com Rem) or computer-generated postal reminders ( Postal) if they did not perform a split test to check the quality of their INR POCT for each calendar month. The adherence of the practices was tracked during the subsequent 8 months subdivided into two 4-month periods both without intervention. Outcomes were measures of split test procedure adherence. Results Both interventions were associated with an increase in adherence to the split test procedure - a factor 6.00 [95% confidence interval (CI) 4.46-7.72] and 8.22 [95% CI 5.87-11.52] for ComRem and Postal, respectively - but there is no evidence that one of the interventions was more effective than the other. In the Com Rem group, the expected number of split tests (out of four) was 2.54 (95% CI 2.33-2.76) versus 2.44 (95% CI 2.24-2.65) in the Postal group, P = 0.14. There was a slight decrease in adherence over the two follow-ups, but neither intervention was better than the other in achieving a lasting improvement in adherence. Conclusion Computer reminders are as efficient as postal reminders in increasing adherence to a quality assurance programme for the INR POCT device in primary care. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To study whether demographic and smoking-related characteristics are associated with participation (reach) in a smoking cessation trial and subsequent use (uptake) of two specific smoking interventions (Internet-based program and proactive telephone counseling). Methods: We used data from a four-arm randomized smoking cessation trial (2011). Participants (n =1,809) were recruited among 9,924 smokers who previously participated in two health surveys in Denmark (2007–2008 and 2010). Interventions were as follows: (1) an Internet-based smoking cessation program, (2) proactive telephone counseling, (3) reactive telephone counseling and (4) a self-help booklet. Results: Reach (defined as the proportion accepting to participate in the trial of those invited) was highest among persons aged 40–59years, women, heavy smokers and persons with long education. Among trial participants, uptake (defined as any use of the specific intervention at 1-month follow-up) was 69% for the Internet-based program, 74% and 9% for proactive and reactive telephone counseling, respectively, and 84% for the self-help booklet. Young age was associated with the uptake of the Internet-based program, and short education was associated with using proactive telephone counseling. Conclusions: Internet-based interventions and proactive telephone counseling appeal to different age and educational groups. Further, offering similar intervention content by a proactive and a reactive approach can be associated with different intervention uptake. [Copyright &y& Elsevier]

The article reports a study to evaluate whether a single injection of platelet-rich plasma (PRP) is more effective than placebo (saline) or glucocorticoid in reducing pain in adults with lateral epicondylitis (LE) after 3 months. The results proved that neither PRP nor glucocorticoid was superior to saline in pain reduction in LE at the primary end point at 3 months. However, injection of glucocorticoid had a short-term pain reducing effect at 1 month in contrast to the other therapies.

Abstract: Obesity is associated with an increased risk of cardiovascular disease, whereas long-chain n-3 polyunsaturated fatty acids (PUFAs) from fish may have cardioprotective and anti-inflammatory effects. This study aimed to investigate the hypothesis that acute and short-term supplementation with a low dose of marine n-3 PUFA exerts an anti-inflammatory effect in overweight subjects. In a double-blind, placebo-controlled trial with 2 parallel groups, 50 overweight subjects were randomized to receive daily supplementation with 2 capsules containing either 2 g of fish oil (1.1 g marine n-3 PUFA) or 2 g of olive oil. Blood samples and adipose tissue biopsies were collected at baseline, after 1 day (acute effect), and after 6 weeks (short-term effect) of supplementation. No significant effects were seen after supplementation for 1 day, but after 6 weeks, subjects receiving fish oil had a significant increase in the n-3 PUFA content of granulocytes and adipose tissue (P < .01). Serum adiponectin levels were increased by 0.55 μg/mL (95% confidence interval, 0.02-1.08) in the fish oil group compared with the control group (P = .04) after 6 weeks of supplementation. Levels of interleukin 6 were inversely correlated to the marine n-3 PUFA content of granulocytes and adipose tissue at baseline (excluding α-linolenic acid). In conclusion, daily supplementation with 1.1 g of marine n-3 PUFA significantly increased serum adiponectin, but the effect was small, and no overall anti-inflammatory effect of the supplement could be demonstrated. [Copyright &y& Elsevier]

The side-lying hip abduction exercise is one of the most commonly used exercises in rehabilitation to increase hip abduction strength, and is often performed without external loading. The aim of this study was to compare the effect of 6 weeks of side-lying hip abduction training, with and without external loading, on hip abduction strength in healthy subjects. Thirty-one healthy, physically active men and women were included in a randomised controlled trial and allocated to side-lying hip abduction training, with or without external loading. Training without external loading was performed using only the weight of the leg as resistance, whereas training with external loading was performed with a relative load corresponding to 10 repetition maximum. Hip abduction strength was measured pre- and post-intervention. Isometric and eccentric hip abduction strength of the trained leg increased after hip abduction training with external loading by 12% and 17%, respectively, ( P<0.05). Likewise, isometric and eccentric hip abduction strength of the trained leg increased after hip abduction training without external loading by 11% and 23%, respectively, ( P<0.001). The strength increases were not different between groups ( P>0.05). Six weeks of side-lying hip abduction training, with or without external loading, increases isometric and eccentric hip abduction strength to the same extent. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To evaluate the effect of multifactorial fall prevention in community-dwelling people aged 65 and older in Denmark. DESIGN: Randomized, controlled clinical trial. SETTING: Geriatric outpatient clinic at Glostrup University Hospital. PARTICIPANTS: Three hundred ninety-two elderly people, mean age 74, 73.7% women, who had visited the emergency department or had been hospitalized due to a fall. INTERVENTION: Identification of general medical, cardiovascular, and physical risk factors for falls and individual intervention in the intervention group. Participants in the control group received usual care. MEASUREMENTS: Falls were registered prospectively in falls diaries, with monthly telephone calls for collection of data. Outcomes were fall rates and proportion of participants with falls, frequent falls, and injurious falls in 12 months. RESULTS: Groups were comparable at baseline. Follow-up exceeded 90.0%. A total of 422 falls were registered in the intervention group, 398 in the control group. Intention-to-treat analysis revealed no effect of the intervention on fall rates (relative risk=1.06, 95% confidence interval (CI)=0.75–1.51), proportion with falls (odds ratio (OR)=1.20, 95% CI 0.81–1.79), frequent falls (OR=0.97, 95% CI=0.60–1.56), or injurious falls (OR=0.97, 95% CI=0.57–1.62). CONCLUSION: A program of multifactorial fall prevention aimed at elderly Danish people experiencing at least one injurious fall was not effective in preventing further falls. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To evaluate the effectiveness of a population-based multi-factorial lifestyle intervention on long-term changes in dietary habits compared to a non-intervention control group. Methods: The study was a randomized controlled lifestyle intervention study, Inter99 (1999–2006), Copenhagen, Denmark, using a high-risk strategy. Participants in the intervention group (n =6 091) had at baseline a medical health-examination and a face-to-face lifestyle counselling. Individuals at high risk of ischemic heart disease were repeatedly offered both individual and group-based counselling. The control group (n =3 324) was followed by questionnaires. Dietary habits were measured by a validated 48-item food frequency questionnaire and changes were analyzed by multilevel analyses. Results: At the 5-year follow-up the intervention group compared to the control group had significantly increased their intake of vegetables (men: net-change: 23 g/week; p =0.04; women: net-change: 27 g/week; p =0.005) and decreased the intake of highly saturated fats used on bread and for cooking (men: OR=0.59 (0.41–0.86); women: OR=0.42 (0.30–0.59)). Significant effects on fruit and fish intake were found at the 3-year follow-up but the effect attenuated at the 5-year follow-up. Conclusion: A population-based multi-factorial lifestyle intervention promoted significant greater beneficial long-term dietary changes compared to the control group, especially the intake of vegetables and saturated fat was improved. [Copyright &y& Elsevier]

Introduction: Smoking is probably the one single factor with the highest impact on reducing the life expectancies of patients with mental illness. This is due to high injurious to health and high rates of smoking among patients with mental illness. In Denmark, 38.8% of patients with mental health problem are smoking. Patients may have problem in participating in ordinary smoking cession programs offered in the community, but they are concerned about the impact of tobacco use on their health and finances and are motivated to stop smoking. Videoconferencing addressing smoking cessation might be an alternative to ordinary consultation at the clinic because the patients can access the treatment at home. Objectives:Weaimed to compare rates of smoking cessation in two interventions Methods: All patients diagnosed with schizophrenia, bipolar disorders or depression receiving treatment and care for mental illness in outpatient clinics will be eligible for inclusion in the study. Measures:Primary outcome is changes in number of cigarettes smoked pr. patients per day in mean at 6-month follow-up. Secondary outcome is abstinence from smoking at 6-month follow-up. This is a two-arm randomized controlled trial. 1. Daily video consultants tailored to the individual patients at the start of smoking cessation and the months after. 2. Treatment as usual consistent of smoking cessation treatment in the community by weekly consultants. Sample size: The smallest number to conclude will be 53 patients in each of the two arms Results: We will start including patients ultimo 2019 and by April 20220 we will have preliminary results. Conclusions: No conclusion yet. [ABSTRACT FROM AUTHOR]

Home visits by health care professionals may constitute a formalized social relationship in which cancer patients can be given emotional and informational support. We aimed at studying the effect of home visits on the well-being of colorectal cancer patients. A total of 249 Danish colorectal cancer patients undergoing abdominal surgery were randomly assigned to a control group or to an intervention group. The intervention group received 10 home visits carried out by a project nurse or a medical doctor during the first 2 years after discharge. Participants were interviewed 3, 6, 12, and 24 months after discharge in order to assess well-being. Using a linear mixed model, we found no overall effect of the intervention on well-being. We recommend that future psychosocial intervention studies include baseline screening for distress and recommend testing the effect of shorter but intensive interventions carried out by trained therapists. Copyright © 2005 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

A large proportion of the contacts with the primary out-of-hours service are consumed by a very small number of inhabitants - the so-called frequent attenders. No convincing general effects on consumption of services were demonstrated after a multi-component intervention aimed at frequent attenders. Objective - To investigate whether the number of frequent attenders (FA) contacts with the out-of-hours service can be reduced by deploying a combination of intervention strategies. Design - A stratified cluster randomized controlled trial, each cluster containing a general practice and all its listed patients. Setting - The out-of-hours service in the county of Northern Jutland (490 000 inhabitants), Denmark. Interventions - The following intervention strategies were deployed: predisposition, individual instruction, economic incitement, continuing medical education meetings, feedback/reminder, and patient-mediated intervention. Subjects - An intervention group of 3500 patients and a control group of 4635 patients. Main outcome measures - Absolute and relative fall in the number of contacts with the out-of-hours service per patient after 6 and 12 months. Results - Analysed by group, intervention patients saw a more pronounced decline in the number of contacts than controls, except for two outcomes. However, this difference was only significant after 12 months. For women aged 17-66 years with 5-9 contacts during the previous 12 months, the decrease was significantly more pronounced in the intervention group for all outcomes (p=0.004-0.042). However, for the rest of the subgroups the effect varied more, and in several cases it was more distinct in the control group. Conclusion - The data collected point towards an effect of intervention on the use of out-of-hours services even if the responses obtained were not uniform and unequivocal. However, one has to consider the problems of multiple comparisons and in conclusion no convincing effect of the intervention was found. [ABSTRACT FROM AUTHOR]

Graphic representation was used to explore to what extent the number needed to treat (NNT) conveys the appropriate notion of benefit for the individual patient in interventions aimed at delaying adverse events. A sample of the Danish population (n = 675) was interviewed face to face, and asked whether they would consent to a hypothetical drug that reduces the risk of heart attack. The benefit of the drug was expressed in terms of NNT and was randomly set at 10, 25, 50, 100, 200, and 400. NNT does not convey information on the proportion of patients being helped by an intervention or the size of the delay of the adverse event intended to be prevented. The proportion of people consenting to the hypothetical drug was about 80%, irrespective of NNT, and some of those who rejected the drug misinterpreted the meaning of NNT. Lay people may have difficulties in understanding the meaning of NNT, and clinicians may do well to use the NNT with caution until more is known about how patients comprehend it. [Copyright &y& Elsevier]

Following a survey among all Danish Haemophiliac patients 49 HIV-negative patients with chronic hepatitis C were offered enrollment in a randomized controlled open label study comparing two different maintenance regimens following standard interferon-alpha-2b treatment. Dose modifications and treatment discontinuation were based upon changes in transaminase levels. Forty-seven patients enrolled received 3 MU of alpha interferon thrice weekly (TIW) for 3 months. Twenty-six nonresponders had their dose increased to 6 MU TIW for an additional 3 months, while 21 responding patients continued on 3 MU TIW. At 6 months, 25 patients with a complete or a partial biochemical response were randomly allocated to either a fixed dose regimen (13 patients) (3 or 6 MU thrice weekly) or an individualized dose regimen (12 patients) tapering interferon dose from 3 or 6 MU by one-third every 2 months if transaminases were persistently normal. The remaining 22 biochemical nonresponders were followed for an additional 6 months without further treatment. After 12 months of treatment, 18 patients (38%) had a virological response, irrespective of regimen, and seven patients (16%) had a sustained virological and biochemical response after 6 months of follow up. Overall, the individualized treatment regimen did not seem to offer any advantage over the fixed dose regimen. The response to alpha interferon treatment in Danish Haemophiliac patients with chronic hepatitis C immediately after treatment is comparable to that obtained in previous studies among nonHaemophiliacs. However, a sustained virological and biochemical response was seen in only 16% of treated patients. [ABSTRACT FROM AUTHOR]

A small proportion of patients account for most of the healthcare costs. Previous studies of supportive interventions have several methodological limitations and results are mixed. This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov , NCT03628469). The main aim of the intervention is to reduce hospital admissions and improve quality of life at six months. A sample size of 4400 is needed and individuals with the highest risk of hospital admission in Denmark are invited by electronic communication and telephone to participate in a 1:1 randomized controlled trial. The intervention group receives one face-to-face start-up session followed by telephone sessions about individual goals regarding participants' knowledge, coping and need of healthcare. Quality of life was assessed with the mental health composite score of the SF-36v2 questionnaire. Primary analyses are done using the intention-to-treat principle. The trial has been approved by The Regional Committee on Health Research Ethics (SJ-677). Intervention nurses do not assume clinical responsibility for the participants and the intervention is an addition to the general healthcare services. The intervention is complex due to challenging skills and behaviors required by nurses, individual tailoring of the intervention, and interacting intervention components. The study therefore includes process evaluation. The research program comprises: 1. Development initiation, 2. Intervention effect, 3. Cost-effectiveness, 4. Organizational implementation, and 5. Participants' experiences. Inclusion to the trial began April 9th, 2018, was completed July 1st, 2019 and follow-up will be completed February 1st, 2020. [ABSTRACT FROM AUTHOR]

Background: Acquiring a traumatic injury constitutes a severe life change for the survivor, but also for the surrounding family. The paradigm of helping the family has primarily been on psychosocial interventions targeting caregivers. However, interventions including both survivor and caregivers should be an essential part of treatment, as the whole family's functional level and mental health can be affected. The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI). The objectives are to investigate if the intervention improves quality of life (QoL) and decreases burden. It is hypothesized that the family intervention improves problem-solving strategies and family dynamics, which will reduce the burden. This may improve the caregivers' mental health, which will improve the support to the survivor and QoL.Methods: The study is an interventional, two-arm, randomized controlled trial. During a 2-year period, a total of 132 families will be included. Participants will be recruited from East-Denmark. Inclusion criteria are (1) TBI or tSCI, (2) ≥ 18 years of age, (3) ≥ 6 months to ≤ 2 years since discharge from hospital, (4) ability to understand and read Danish, (5) cognitive abilities that enable participation, and (6) a minimum of one family member actively involved in the survivor's life. Exclusion criteria are (1) active substance abuse, (2) aphasia, (3) prior neurologic or psychiatric diagnose, and (4) history of violence. Within each disease group, families will be allocated randomly to participate in an intervention or a control group with a ratio 1:1. The intervention groups receive the family intervention consisting of eight sessions of 90 min duration. Families in the control groups receive 2 h of psychoeducation. All participants complete questionnaires on QoL, self-perceived burden, family dynamics, problem-solving strategies, mental health, and resilience at pre-intervention, post-intervention, and 6-month follow up.Conclusion: If the intervention is found to have effect, the study will contribute with novel knowledge on the use of a manual-based intervention including the entire family. This would be of clinical interest and would help families living with the consequences of TBI or tSCI.Trials Registration: ClinicalTrials.gov, NCT03814876. Retrospectively registered on 24 January 2019. [ABSTRACT FROM AUTHOR]