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Background: The 15-method is a targeted screening and treatment approach for alcohol problems in primary care. The 15-method used in primary care has proven as effective as specialized treatment for mild to moderate alcohol dependence in Sweden. A feasibility study of the 15-method in Danish primary care found the method acceptable and feasible. Aims: To evaluate the effectiveness of the 15-method in a Danish primary care setting in (1) lowering the proportion of patients exceeding the Danish low-risk alcohol consumption limit of ten standard units per week and a maximum of four standard units on a single day for men and women, and (2) increasing the likelihood of alcohol use being addressed during a consultation in general practice. Further, the rate of prescribed pharmacological treatment for alcohol problems (Disulfiram, Naltrexone, Acamprosate, and Nalmefene) will be measured along with the use of the biomarkers Alanine Transaminase and Gamma-Glutamyl Transferase. Methods: Stepped wedge cluster randomized controlled trial in sixteen general practices in the Region of Southern Denmark. Following a three-month baseline, the practices are randomly assigned to launch dates in one of four clusters. General practitioners and nurses receive three hours of training in the 15-method before launch. Patient questionnaires will collect data on alcohol consumption levels among patients affiliated with the practices. The healthcare professionals will register consultations in which alcohol is addressed in their patient filing system. Pharmacological treatment rates and the use of biomarkers will be collected through Danish national registries. The study follows the Medical Research Council's guidelines for developing and evaluating complex interventions. Discussion: From the patient's perspective, the 15-method may help identify alcohol-related problems at an earlier stage with flexible treatment offers in a familiar setting. For healthcare professionals, it addresses a traditionally challenging topic by equipping them with concrete tools, communication training, and clear treatment directives. From a societal perspective, primary care holds a unique position to identify hazardous and harmful alcohol use across different age groups, with potential public health and economic benefits through early identification and intervention. Trial registration: Clinicaltrials.gov NCT05916027. Retrospectively registered 22 June 2023. [ABSTRACT FROM AUTHOR]

Background and aims: Despite the high prevalence and negative effects of hazardous substance use, few young adults enter treatment. Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, has proved efficacious in promoting treatment entry. The aim of the current trial was to compare the efficacy of CRAFT with an active control for parents of young adults (aged 18–24 years) with hazardous substance use. Design: This was a randomized controlled superiority trial comparing CRAFT (n = 58) with an active control group receiving manualized counselling (n = 55), with outcome assessments at 6, 12 and 24 weeks (primary end‐point). A sequential design with a stopping rule was added post recruitment commencement. Setting: The study took place in two outpatient clinics for young adults in Stockholm, Sweden, and subsequently via video‐conference due to COVID‐19. Participants: Between October 2018 and May 2021, 113 participants (92% female) who were parents of young adults (87% male) were recruited. Recruitment was discontinued when 70% of the planned sample had been recruited, following an interim analysis of the primary outcome showing no difference between conditions. Intervention and comparator: Participants were randomized (ratio 1 : 1) to eight manual‐based individual CRAFT sessions or five individual manual‐based counselling sessions + one voluntary psychoeducative group session, delivered over maximum 14 weeks. Measurements The primary outcome measure was the rate of young adult entry in substance use treatment during the trial period (24 weeks). Findings At the 24 weeks follow‐up, 19 (33%) of CRAFT participants and 17 (31%) of counselling participants had reported young adult treatment entry, with no difference between conditions (odds ratio CRAFT versus counselling 0.84, 95% confidence interval = 0.35; 1.99, P = 0.700). Both conditions reported clinically relevant reductions in young adult substance use, but no change in participants' levels of depression, anxiety or stress. Conclusions: This trial showed no statistically significant evidence that Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, is more efficacious than manual‐based counselling regarding treatment entry for young adults. [ABSTRACT FROM AUTHOR]

Parenting programs have been shown to empower parents and prevent mental health problems in children. However, few programs are designed to promote wellbeing, which led to the development of the Swedish-promotive universal program, "All Children in Focus" (ACF). This study aimed to understand the effects of parents' participation in the ACF program on parents' emotion regulation and parenting practices over a 6-month follow-up and if intervention-produced changes predict child wellbeing (CW). Parental self-efficacy (PSE) was also included to assess the relation with parental outcomes and CW. This is an evaluation of a multicenter randomized waitlisted control trial conducted in Stockholm County, Sweden, with parents of children aged 3 to 12 years (n = 621) in 2012. Parents were randomized 1:1 to enter the program or to a waitlist. Questionnaires were completed by parents at baseline, post-intervention, and 6 months post-baseline. We used generalized mixed modeling to test effects on parental outcomes over time and regression analyses to study the predictive role of parental outcomes on CW. From baseline to the post- and to the 6-month follow-ups, parents in the intervention group reported greater levels of emotion regulation skills, cognitive reappraisal, and positive parenting than did parents in the control group. A decrease in negative and harsh parenting was evident in both groups, although it was greater in the intervention group. An increase in PSE was associated with high negative parenting at baseline in the intervention group. Child gender moderated positive parenting, suggesting that parents of girls in the intervention group had more favorable development of positive strategies. The findings indicate that a change in PSE predicts a change in CW at 6 months. The ACF program can be used to strengthen and develop parenting. This study advances our knowledge about the potential advantages of using a health-promoting approach to strengthen the wellbeing of families in the general population. Clinical trial registration: ISRCTN70202532 Current Controlled Trials [ABSTRACT FROM AUTHOR]

Background and aims: Controlled drinking (CD) is an attractive treatment goal for a large proportion of individuals with alcohol use disorder (AUD), but the availability of treatment methods supporting a goal of CD is scarce. We tested if behavioural self‐control training (BSCT) was superior to motivational enhancement therapy (MET) for individuals with AUD with a treatment goal of CD. Design: Randomized controlled two‐group trial. Follow‐ups were conducted at 12 and 26 weeks (primary end‐point) after inclusion. Setting: Three specialized dependency care clinics in Stockholm, Sweden. Participants: Two hundred and fifty self‐referred adults (52% men) fulfilling criteria of AUD (DSM‐5) and a stated treatment goal of CD. Intervention and comparator: BSCT (n = 125), a five‐session treatment based on cognitive behavioural therapy versus the active comparator, MET (n = 125), containing four sessions based on Motivational Interviewing. Measurements Primary outcome measure was mean weekly alcohol consumption at the 26‐week follow‐up, adjusted for baseline consumption. Conclusions: A randomized controlled trial found no evidence of a difference between behavioural self‐control training and motivational enhancement therapy in reducing weekly alcohol consumption. Both groups substantially reduced consumption and behavioural self‐control training was superior in reducing hazardous drinking. [ABSTRACT FROM AUTHOR]

Background: The number of people with common mental disorders (CMDs), especially stress-related disorders, has increased in several countries, including Sweden, during the past decade. Patients seeking care for long-term stress report severe symptoms. Although person-centred care (PCC) has shown several benefits, studies evaluating the effects of a PCC eHealth intervention on patients with CMDs are scarce. Objective: The aim of this study was to compare levels of self-reported symptoms of burnout between a control group receiving treatment as usual (TAU) and an intervention group receiving TAU with the addition of a person-centred eHealth intervention, in patients on sick leave for CMDs. Methods: This study reports analysis of a secondary outcome measure from a randomized controlled trial. Patients (n = 209) on sick leave for CMDs were recruited from nine primary health care centres and allocated to either a control group (n = 107) or an intervention group (n = 102). The intervention consisted of phone support and an interactive digital platform built on PCC principles. Self-reported symptoms of burnout were assessed using the Shirom-Melamed Burnout Questionnaire (SMBQ) at baseline and at 3 and 6 months. Results: Our findings showed changes in SMBQ scores over time in both the control and the intervention group. There was no significant difference in SMBQ scores between the groups; however, a difference in change over time between the groups was observed. The SMBQ scores decreased significantly more in the intervention group than in the controls between 0 and 3 months and between 0 and 6 months. No differences in change between the two groups were seen between the 3- and 6-month follow-ups. Conclusion: This person-centred eHealth intervention for patients on sick leave for CMDs showed a slight initial effect in reducing symptoms of burnout. Taking into account that both groups reported comparable SMBQ scores throughout the study period, the overall effect may be considered limited. Trial registration: : The trial was registered in ClinicalTrials.gov (Identifier NCT03404583). Date of registration: 19/01/2018. https://clinicaltrials.gov/ct2/show/NCT03404583. [ABSTRACT FROM AUTHOR]

Background: Surgical resection followed by adjuvant mFOLFIRINOX (5-fluorouracil with leucovorin, irinotecan, and oxaliplatin) is currently the standard of care for patients with resectable pancreatic cancer. The main concern regarding adjuvant chemotherapy is that only half of patients actually receive adjuvant treatment. Neoadjuvant chemotherapy, on the other hand, guarantees early systemic treatment and may increase chemotherapy use and thereby improve overall survival. Furthermore, it may prevent futile surgery in patients with rapidly progressive disease. However, some argue that neoadjuvant therapy delays surgery, which could lead to progression towards unresectable disease and thus offset the potential benefits. Comparison of perioperative (i.e., neoadjuvant and adjuvant) with (only) adjuvant administration of mFOLFIRINOX in a randomized controlled trial (RCT) is needed to determine the optimal approach. Methods: This multicenter, phase 3, RCT will include 378 patients with resectable pancreatic ductal adenocarcinoma with a WHO performance status of 0 or 1. Patients are recruited from 20 Dutch centers and three centers in Norway and Sweden. Resectable pancreatic cancer is defined as no arterial contact and ≤ 90 degrees venous contact. Patients in the intervention arm are scheduled for 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (2-week cycle of oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, irinotecan 150 mg/m2 at day 1, followed by 46 h continuous infusion of 5-fluorouracil 2400 g/m2). Patients in the comparator arm start with surgery followed by 12 cycles of adjuvant mFOLFIRINOX. The primary outcome is overall survival by intention-to-treat. Secondary outcomes include progression-free survival, resection rate, quality of life, adverse events, and surgical complications. To detect a hazard ratio of 0.70 with 80% power, 252 events are needed. The number of events is expected to be reached after the inclusion of 378 patients in 36 months, with analysis planned 18 months after the last patient has been randomized. Discussion: The multicenter PREOPANC-3 trial compares perioperative mFOLFIRINOX with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer. Trial registration: Clinical Trials: NCT04927780. Registered June 16, 2021. [ABSTRACT FROM AUTHOR]

Background and Aims: Most alcohol‐dependent people have a moderate level of dependence. General practitioners (GPs) hesitate to engage in this area, and need to have access to treatment they find applicable and feasible to use. The aim of this present study was to test if an open‐ended internet‐based cognitive–behavioral therapy (iCBT) program added to treatment‐as‐usual (TAU) is more effective than TAU‐only for alcohol‐dependent patients in primary care. Design, Setting and Participants: The present study was a two‐group, parallel, randomized controlled superiority trial comparing iCBT+TAU versus TAU‐only at 3‐ and 12‐month follow‐ups. TAU was delivered at 14 primary care centers in Stockholm, Sweden. A total of 264 patients (mean age 51 years, of whom 148 were female and 116 were male) with alcohol dependence and hazardous alcohol consumption were enrolled between September 2017 and November 2019. Measurements: Participants were randomized at a ratio of 1:1 to iCBT, as a self‐help intervention added to TAU (n = 132) or to TAU‐only (n = 132). The GPs gave participants in both treatment arms feedback on the assessments and biomarkers and offered TAU at the primary care center. Primary outcome was weekly alcohol consumption in g/week at 12‐month follow‐up, analyzed according to intention‐to‐treat (n = 132 + 132). The per‐protocol analysis included participants who completed at least one module of iCBT (n = 102 + 132). Findings There was no significant difference in weekly alcohol consumption between iCBT+TAU and TAU in the intention‐to‐treat (ITT) analysis at 12‐month follow‐up [iCBT+TAU = 133.56 (95% confidence interval, CI = 100.94–166.19) and TAU = 176.20 (95% CI = 144.04–208.35), P = 0.068, d = 0.23]. In the per‐protocol analysis, including only those who initiated iCBT, the iCBT+TAU group showed lower mean weekly alcohol consumption compared with TAU [iCBT+TAU = 107.46 (95% CI = 71.17–143.74), TAU = 176.00 (95% CI = 144.21–207.80), P = 0.010, d = 0.42]. Conclusions: In Sweden, an internet‐based cognitive–behavioral program added to treatment‐as‐usual to reduce alcohol consumption showed weak evidence of a benefit at 12 months in the intention‐to‐treat analysis and good evidence of a benefit in the per‐protocol analysis. [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: In Sweden, 72% of people with dementia live in ordinary housing. Of these, 50% receive home care services. Older people with dementia may benefit from developments in decision-making support which aim to facilitate their ability to communicate their personal needs and preferences with care managers and staff in home care services. In this study, we will test and evaluate the use of TalkingMats in Swedish municipal home care services for older people with mild to moderate dementia. TalkingMats is a low-technology communication tool, to help people with communication difficulties express their views. It uses a simple system of picture symbols which are placed on a textured mat. This study will provide insight into the extent to which TalkingMats benefits older people with dementia to feel more involved in decisions related to home care services. In addition, this study will assess the extent to which the use of TalkingMats promotes service providers' efforts to involve service recipients in decision making. The implementation of TalkingMats in home care services will also be studied. Methods: A parallel group, two-armed randomized controlled trial design in which TalkingMats and Usual Conversation Method will be compared. Two specific situations where older people with dementia must make decisions about home care services will be studied. First, a follow-up needs-assessment conversation between study participants and care managers will be studied. Second, a conversation between participants and home care staff regarding the delivery of the decided home care services will be studied. In addition, a qualitative approach will be used to gain an understanding of study participant and service provider experiences of the impact and implementation of TalkingMats. Discussion: The combined exploratory, descriptive, and experimental study design is considered an important strength which will facilitate multi-facetted knowledge production concerning the involvement and communication needs of older people with dementia generally and within the context of home care services specifically. Combining qualitative and quantitative methods will maximize our ability to assess the effects of TalkingMats. Trial registration: ClinicalTrials.gov ID: NCT05561998. Registered in September 28, 2022. [ABSTRACT FROM AUTHOR]

Background: Childhood overweight and obesity is a public health priority. We have previously reported the efficacy of a parent-oriented mobile health (mHealth) app-based intervention (MINISTOP 1.0) which showed improvements in healthy lifestyle behaviors. However, the effectiveness of the MINISTOP app in real-world conditions needs to be established. Objective: To evaluate the real-world effectiveness of a 6-month mHealth intervention (MINISTOP 2.0 app) on children's intake of fruits, vegetables, sweet and savory treats, sweet drinks, moderate-to-vigorous physical activity, and screen time (primary outcomes), and on parental self-efficacy (PSE) for promoting healthy lifestyle behaviors, and children's body mass index (BMI) (secondary outcomes). Methods: A hybrid type 1 effectiveness-implementation design was utilized. For the effectiveness outcomes, a two-arm, individually randomized controlled trial was conducted. Parents (n = 552) of 2.5-to-3-year-old children were recruited from 19 child health care centers across Sweden, and, randomized to either a control (standard care) or intervention group (MINISTOP 2.0 app). The 2.0 version was adapted and translated into English, Somali and Arabic to increase reach. All recruitment and data collection were conducted by the nurses. Outcomes were assessed at baseline and after six months, using standardized measures (BMI) and a questionnaire (health behaviors, PSE). Results: Among the participating parents (n = 552, age: 34.1 ± 5.0 years), 79% were mothers and 62% had a university degree. Twenty-four percent (n = 132) of children had two foreign-born parents. At follow-up, parents in the intervention group reported lower intakes of sweet and savory treats (-6.97 g/day; p = 0.001), sweet drinks (-31.52 g/day; p < 0.001), and screen time (-7.00 min/day; p = 0.012) in their children compared to the control group. The intervention group reported higher total PSE (0.91; p = 0.006), PSE for promoting healthy diet (0.34; p = 0.008) and PSE for promoting physical activity behaviors (0.31; p = 0.009) compared to controls. No statistically significant effect was observed for children's BMI z-score. Overall, parents reported high satisfaction with the app, and 54% reported using the app at least once a week. Conclusion: Children in the intervention group had lower intakes of sweet and savory treats, sweet drinks, less screen time (primary outcomes) and their parents reported higher PSE for promoting healthy lifestyle behaviors. Our results from this real-world effectiveness trial support the implementation of the MINISTOP 2.0 app within Swedish child health care. Trial registration: Clinicaltrials.gov NCT04147039; https://clinicaltrials.gov/ct2/show/NCT04147039 [ABSTRACT FROM AUTHOR]

Objective: To study the effect of the birthing room design on nulliparous women's childbirth experience up to 1 year after birth. Background: Although it is known that the birth environment can support or hinder birth processes, the impact of the birthing room design on maternal childbirth experience over time is insufficiently studied. Methods: The Room4Birth randomized controlled trial was conducted at a labor ward in Sweden. Nulliparous women in active stage of spontaneous labor were randomized (n = 406) to either a regular birthing room (n = 202) or a new birthing room designed with more person-centered considerations (n = 204). Childbirth experiences were measured 2 hr, 3 months, and 12 months after birth by using a Visual Analogue Scale of Overall Childbirth Experience (VAS-OCE), the Fear of Birth Scale (FOBS), and the Childbirth Experience Questionnaire (CEQ2). Results: Women randomized to the new room had a more positive childbirth experience reported on the VAS-OCE 3 months (p =.002) and 12 months (p =.021) after birth compared to women randomized to a regular room. Women in the new room also scored higher in the total CEQ2 score (p =.039) and within the CEQ2 subdomain own capacity after 3 months (p =.028). The remaining CEQ2 domains and the FOBS scores did not differ between the groups. Conclusions: These findings show that a birthing room offering more possibilities to change features and functions in the room according to personal needs and requirements, positively affects the childbirth experience of nulliparous women 3 and 12 months after they have given birth. [ABSTRACT FROM AUTHOR]

Background: No definite consensus has been reached yet on the best treatment strategy for the large group of infants hospitalised with bronchiolitis or pneumonia. Minimal handling is often recommended, although not evaluated scientifically. There is a need to evaluate the management, as the infants often are critically affected, and the costs for society are high. The aim of this RCT was to evaluate the most common physiotherapy intervention in Sweden for this patient group, including frequent changes in body position and stimulation of physical activity, compared to standard care. Methods: Infants 0-24 months old, without previous cardiac or respiratory diagnoses and born in gestational week 35+, were recruited in two Swedish hospitals. The participants (n=109) were randomised to either interventions in addition to standard care (intervention group) or to standard care alone (control group). The primary outcome measure was time to improvement. The secondary outcomes were immediate changes in oxygen saturation, heart rate and respiratory rate, time to improved general condition (parents' assessment), and lung complications. Results: The median time to improvement was 6 hours in both groups (p=0.54). The result was similar when we adjusted for age in months, sex, tobacco smoke exposure, heredity for asthma/atopic disease, and early stage of the infection (for those with RSV), p=0.69. Analyses of the immediate changes showed no significant differences either (p=0.49-0.89). Time to improved general condition was median 3 hours in the intervention group and 6 hours in the control group, p=0.76. No lung complications occurred. Conclusions: No statistically significant differences in outcomes were detected between the intervention group and the control group. Both strategies were found to be equally effective and safe, indicating that the current recommendation of minimal handling for these infants should be reconsidered. Furthermore, the findings suggest that this treatment can be safely continued. [ABSTRACT FROM AUTHOR]

Background: Short-term trials conducted in adults with type 2 diabetes mellitus (T2DM) showed that reducing sedentary behaviour by performing regular short bouts of light-intensity physical activity enhances health. Moreover, support for reducing sedentary behaviour may be provided at a low cost via mobile health technology (mHealth). There are a wide range of mHealth solutions available including SMS text message reminders and activity trackers that monitor the physical activity level and notify the user of prolonged sitting periods. The aim of this study is to evaluate the effects of a mHealth intervention on sedentary behaviour and physical activity and the associated changes in health in adults with T2DM. Methods: A dual-arm, 12-month, randomized controlled trial (RCT) will be conducted within a nationwide Swedish collaboration for diabetes research in primary health care. Individuals with T2DM (n = 142) and mainly sedentary work will be recruited across primary health care centres in five regions in Sweden. Participants will be randomized (1:1) into two groups. A mHealth intervention group who will receive an activity tracker wristband (Garmin Vivofit4), regular SMS text message reminders, and counselling with a diabetes specialist nurse, or a comparator group who will receive counselling with a diabetes specialist nurse only. The primary outcomes are device-measured total sitting time and total number of steps (activPAL3). The secondary outcomes are fatigue, health-related quality of life and musculoskeletal problems (self-reported questionnaires), number of sick leave days (diaries), diabetes medications (clinical record review) and cardiometabolic biomarkers including waist circumference, mean blood pressure, HbA1c, HDL-cholesterol and triglycerides. Discussion: Successful interventions to increase physical activity among those with T2DM have been costly and long-term effectiveness remains uncertain. The use of mHealth technologies such as activity trackers and SMS text reminders may increase awareness of prolonged sedentary behaviour and encourage increase in regular physical activity. mHealth may, therefore, provide a valuable and novel tool to improve health outcomes and clinical management in those with T2DM. This 12-month RCT will evaluate longer-term effects of a mHealth intervention suitable for real-world primary health care settings. Trial registration : ClinicalTrials.gov NCT04219800. Registered on 7 January 2020. [ABSTRACT FROM AUTHOR]

Background: Brief Admission by self-referral (BA) is a crisis-management intervention standardized for individuals with self-harm at risk of suicide. We analyzed its health-economic consequences., Materials and Methods: BA plus treatment as usual (TAU) was compared with TAU alone in a 12-month randomized controlled trial with 117 participants regarding costs for hospital admissions, coercive measures, emergency care and health outcomes (quality-adjusted life years; QALYs). Participants were followed from 12 months before baseline to up to five years after., Results: Over one year BA was associated with a mean annual cost reduction of 4800 or incremental cost of 4600 euros, depending on bed occupancy assumption. Cost-savings were greatest for individuals with >180 admission days in the year before baseline. In terms of health outcomes BA was associated with a QALY gain of 0.078. Uncertainty analyses indicated a significant QALY gain and ambiguity in costs, resulting in BA either dominating TAU or costing 59 000 euros per gained QALY., Conclusion: BA is likely to produce QALY gains for individuals living with self-harm and suicidality. Cost-effectiveness depends on targeting high-need individuals and comparable bed utilization between BA and other psychiatric admissions. Future research should elaborate the explanatory factors for individual variations in the usage and benefit of BA.

Objective: To compare experiences of the second stage of labour in women randomised to assistance by one or by two midwives to reduce severe perineal trauma (SPT)., Design: Analysis of a secondary outcome within the Swedish Oneplus multicentre randomised trial., Setting: Five obstetric units in Sweden between December 2018 and March 2020., Participants: Inclusion criteria in the Oneplus trial were women opting for their first vaginal birth from gestational week 37+0 with a singleton pregnancy and a live fetus in the vertex presentation. Further inclusion criteria were language proficiency in Swedish, English, Arabic or Farsi. Exclusion criteria were multiple pregnancies, intrauterine fetal demise and planned caesarean section. Of the 3059 women who had a spontaneous vaginal birth, 2831 women had consented to participate in the follow-up questionnaire., Interventions: Women were randomly assigned (1:1) to assistance by two midwives (intervention group) or one midwife (standard care) when reaching the second stage of labour., Outcome Measures: Data were analysed by intention to treat. Comparisons between intervention and standard care regarding experiences of the second stage of labour were evaluated with items rated on Likert scales. The Student's t-test was used to calculate mean differences with 95% CIs., Results: In total 2221 (78.5%) women responded to the questionnaire. There were no statistically significant differences regarding women's experiences of being in control, feelings of vulnerability or pain. Women randomised to be assisted by two midwives agreed to a lesser extent that they could handle the situation during the second stage (mean 3.18 vs 3.26, 95% CI 0.01 to 0.15). Conducted subgroup analyses revealed that this result originated from one of the study sites., Conclusions: The intervention's lack of impact on the experience of the second stage is of importance considering the reduction in SPT when being assisted by two midwives., Trial Registration Number: NCT03770962., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Aims: Conditional average treatment effects are often reported in intervention studies, in which assumptions are made regarding how effects are similar across a heterogeneous sample. Nonetheless, differing factors, such as genetics, age, and sex, can impact an intervention's effect on outcomes. The study aimed to estimate the individualized effects of a digital alcohol intervention among individuals looking online to reduce their drinking., Methods: We used data from a randomized controlled trial (RCT), including 2129 adults from the Swedish general population. The RCT concerned a text message-based alcohol intervention that sought to engender change through increasing knowledge on how to change and instilling confidence in changing behaviour. Outcomes were total weekly alcohol consumption and monthly heavy episodic drinking. Individualized treatment effects were modelled using baseline characteristics (age, gender, alcohol consumption, and psychosocial variables) and engagement with the intervention content., Results: We found evidence that the effects of the digital alcohol intervention were heterogeneous concerning participants' age, baseline alcohol consumption, confidence, and importance. For heavy episodic drinking, there was evidence that effects were heterogeneous concerning age, sex, and baseline alcohol consumption. Overall, women, older individuals, and heavier drinkers benefitted more from the intervention in terms of effect size. In addition, participants who engaged more with the goal-setting and screening content reported better outcomes., Conclusions: The results highlight how different individuals respond differently to a digital alcohol intervention. This allows insight into who benefits the most and least from the intervention and highlights the potential merit of designing interventions adapted to different individuals' needs., (© The Author(s) 2024. Medical Council on Alcohol and Oxford University Press.)

Introduction: Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. Randomised controlled trials (RCTs) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The objective of this study is to compare implant-based and autologous breast reconstruction in non-irradiated patients. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction., Methods and Analysis: The study design partially randomised patient preference trial might be a way to overcome the aforementioned challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose the method. The study is designed as a superiority trial based on the patient-reported questionnaire BREAST-Q and 124 participants will be randomised. In the preference cohort, patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60 months. Embedded qualitative studies and within-trial economic evaluation will be performed. The primary outcome is patient-reported breast-specific quality of life/satisfaction, and the secondary outcomes are complications, factors affecting satisfaction and cost-effectiveness., Ethics and Dissemination: The study has been approved by the Swedish Ethical Review Authority (2023-04754-01). Results will be published in peer-reviewed scientific journals and presented at peer-reviewed scientific meetings., Trial Registration Number: NCT06195865., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: There is limited research on prevention of mental ill-health of school personnel and the systematic management of school work environments. The aim of this study was to assess the effectiveness of implementing the guideline recommendations for the prevention of mental ill-health in schools, in particular, whether there was a difference in adherence to guideline recommendations between a multifaceted (group 1) and single implementation strategy (group 2) from baseline to 6 and to 12 months.Method: We conducted a cluster-randomized controlled trial with a 6- and 12-month follow-up. Data was collected from nearly 700 participants in 19 Swedish schools. Participants were school personnel working under the management of a school principal. The single implementation strategy consisted of one educational meeting, while the multifaceted implementation strategy comprised an educational meeting, an ongoing training in the form of workshops, implementation teams and Plan-Do-Study-Act cycles. Adherence was measured with a self-reported questionnaire. Generalized Linear Mixed Models were used to assess the difference between groups in adherence to the guideline between baseline, 6-, and 12-months follow-up.Results: There were no statistically significant differences between the groups in improvements in adherence to the guideline between baseline, 6-, and 12-months follow-up. However, among those schools that did not undergo any organizational changes during the 12 months of the study significant differences between groups were observed at 12 months for one of the indicators.Conclusions: The multifaceted strategy was no more effective than the single strategy in improving guideline adherence. There are some limitations to the study, such as the measurement of the implementation outcome measure of adherence. The outcome measure was developed in a systematic manner by the research team, assessing specific target behaviors relevant to the guideline recommendations, however not psychometrically tested, which warrants a careful interpretation of the results.Trial Registration: ClinicalTrials.gov, 150571 . Registered 12 September 2017. [ABSTRACT FROM AUTHOR]

Background: Although transition programs have been evaluated for adolescents with chronic conditions, these have rarely involved process evaluations. Indeed, outcomes of complex interventions are dependent on how the intervention is implemented in practice and evaluations of implementation process are therefore pivotal. The aim of this study was to evaluate the extent to which a transition program for adolescents with congenital heart disease was delivered as intended. Research questions were 1) to what level of fidelity was the program delivered? and 2) what potential moderating factors affected the delivery of the program and overall fidelity?Methods: A mixed methods design was used, where a process evaluation was embedded in the STEPSTONES randomized controlled trial in Sweden. The implementation fidelity framework by Carrol (2007) and Hasson (2010) was used to design, collect and analyze data. Quantitative data consisted of intervention records on adherence and were analyzed with descriptive statistics. Qualitative data on moderators affecting fidelity were collected through interviews, log-books and focus group interviews with healthcare professionals implementing the intervention and participatory observations of the implementation process. Data were analyzed with deductive content analysis. Triangulation was used to integrate quantitative and qualitative data within the fidelity framework.Results: Six out of eight components of the transition program were delivered to an extent that adhered to the program theory or achieved a high level of fidelity. However, components involving peer support had a low attendance by the participating sample (32.2%), and the joint transfer meeting was challenging to implement, despite achieving high adherence. Moderators affecting the implementation process were the adolescent's and healthcare professional's engagement in the intervention, contextual factors and a lack of standard operating procedures for all components in the program.Conclusion: Barriers and facilitators for a future implementation of transition programs have been illuminated in this study. The use of an implementation fidelity framework in the process evaluation proved successful in providing a comprehensive evaluation of factors affecting the implementation process. However, implementation fidelity must be considered in relation to adaptations to the local and personal prerequisites in order to create interventions that can achieve fit. [ABSTRACT FROM AUTHOR]

Background: There is a need for high-quality research regarding exercise interventions for persons with anxiety disorders. We investigate whether a 12-week exercise intervention, with different intensities, could reduce anxiety symptoms in patients with anxiety disorders.Methods: 286 patients were recruited from primary care in Sweden. Severity of symptoms was self-assessed using the Beck Anxiety Inventory (BAI) and the Montgomery Åsberg Depression Rating Scale (MADRS-S). Participants were randomly assigned to one of two group exercise programs with cardiorespiratory and resistance training and one control/standard treatment non-exercise group, with 1:1:1 allocation.Results: Patients in both exercise groups showed larger improvements in both anxiety and depressive symptoms compared to the control group. No differences in effect sizes were found between the two groups. To study a clinically relevant improvement, BAI and MADRS-S were dichotomized with the mean change in the control group as reference. In adjusted models the odds ratio for improved symptoms of anxiety after low-intensity training was 3.62 (CI 1.34-9.76) and after moderate/high intensity 4.88 (CI 1.66-14.39), for depressive symptoms 4.96 (CI 1.81-13.6) and 4.36 (CI 1.57-12.08) respectively. There was a significant intensity trend for improvement in anxiety symptoms.Limitations: The use of self-rating measures which bears the risk of an under- or overestimation of symptoms.Conclusions: A 12-week group exercise program proved effective for patients with anxiety syndromes in primary care. These findings strengthen the view of physical exercise as an effective treatment and could be more frequently made available in clinical practice for persons with anxiety issues. [ABSTRACT FROM AUTHOR]

Background/purpose: Non-resuscitation fluids constitute the majority of fluid administered for septic shock patients in the intensive care unit (ICU). This multicentre, randomized, feasibility trial was conducted to test the hypothesis that a restrictive protocol targeting non-resuscitation fluids reduces the overall volume administered compared with usual care., Methods: Adults with septic shock in six Swedish ICUs were randomized within 12 h of ICU admission to receive either protocolized reduction of non-resuscitation fluids or usual care. The primary outcome was the total volume of fluid administered within three days of inclusion., Results: Median (IQR) total volume of fluid in the first three days, was 6008 ml (interquartile range [IQR] 3960-8123) in the restrictive fluid group (n = 44), and 9765 ml (IQR 6804-12,401) in the control group (n = 48); corresponding to a Hodges-Lehmann median difference of 3560 ml [95% confidence interval 1614-5302]; p < 0.001). Outcome data on all-cause mortality, days alive and free of mechanical ventilation and acute kidney injury or ischemic events in the ICU within 90 days of inclusion were recorded in 98/98 (100%), 95/98 (98%) and 95/98 (98%) of participants respectively. Cognition and health-related quality of life at six months were recorded in 39/52 (75%) and 41/52 (79%) of surviving participants, respectively. Ninety out of 134 patients (67%) of eligible patients were randomized, and 15/98 (15%) of the participants experienced at least one protocol violation., Conclusion: Protocolized reduction of non-resuscitation fluids in patients with septic shock resulted in a large decrease in fluid administration compared with usual care. A trial using this design to test if reducing non-resuscitation fluids improves outcomes is feasible., Trial Registration: Clinicaltrials.gov, NCT05249088, 18 February 2022. https://clinicaltrials.gov/ct2/show/NCT05249088., (© 2024. The Author(s).)

Purpose: Pregnant women in Sweden are mildly iodine deficient. We investigated the effect of daily iodine supplementation on the iodine and thyroid status of pregnant women. Methods: In this pilot, randomized, double-blind trial, 200 thyroid-healthy pregnant women were recruited at mean (standard deviation) pregnancy week 8.85 (1.62) and assigned (1:1) to daily intake of a multivitamin tablet with or without 150 μg of iodine. Urine and serum samples were collected at baseline and once during the second and third trimesters. Urinary iodine concentration (UIC), serum thyroglobulin (Tg), thyroid-stimulating hormone (TSH), free thyroxine (FT4), and thyroid peroxidase antibodies (TPOabs) were analyzed. Neonatal TSH data were collected. UIC and Tg were also analyzed in a group of 89 thyroid-healthy non-pregnant women of reproductive age (WRA). Results: At baseline, the intervention and the control groups had similar median UIC (interquartile range (IQR)): 110 μg/L (74–119) and 111 μg/L (66–168), respectively. The intervention group reached iodine sufficiency with median UIC (IQR) 139 μg/L (89–234) and 136 μg/L (91–211) in the second and third trimester, respectively, without significant difference from the lower limit of the recommended range, i.e. 150–250 μg/L (p = 0.42 and p = 0.87, respectively). The intervention group had higher median UIC and lower median Tg compared to the control group during the second (p < 0.001 and p = 0.019, respectively) and third trimester (p < 0.001 and p = 0.003, respectively), whereas thyroid hormones, serum TPOabs, and neonatal TSH were similar. The WRA group presented median UIC (IQR) 65 μg/L (30–98) and median Tg (IQR) 18 μg/L (13–27). Conclusion: A daily supplement containing 150 μg of iodine to a group of pregnant women with mild iodine deficiency improved the iodine status from mild ID to iodine sufficiency. This improvement seems to have had a positive impact on maternal thyroglobulin. This study is now under extension to investigate the children's neuropsychological development. Trial registration: ClinicalTrials.gov Identifier NCT02378246, May 3, 2015, retrospectively registered. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the effects of a home-based one-year case management intervention in older people with functional dependency and repeated contact with the health care services on self-reported falls and self-reported injurious falls. Methods: The study was a randomized controlled trial with repeated follow-ups. The sample (n = 153) was consecutively and randomly assigned to the intervention group (n = 80, mean age = 81.4 [SD 5.9]) or control group (n = 73, mean age = 81.6 [SD 6.8]). The intervention group received a case management intervention which comprised monthly home visits during 12 months by nurses and physiotherapists employing a multifactorial preventive approach. Results: In the intervention group, 96 falls occurred during the intervention period compared with 85 falls in the control group (p = .900). There were 40 and 38 injurious falls (p = .669) in the intervention and control groups, respectively. Conclusions: This home-based case management intervention was not able to prevent falls or injurious falls. [ABSTRACT FROM AUTHOR]

Background: During the past decade there has been some evaluation of transition programmes for adolescents with chronic conditions. However, this has rarely involved process evaluations focusing on mechanisms leading to outcomes, thus hampering implementation of these complex interventions. Our aim was to (I) describe adolescents' and parents' experiences of participating in a person-centred transition programme aiming to empower them in transition to adulthood and (II) explore the mechanisms of impact.Methods: A qualitative process evaluation was performed, embedded in a randomized controlled trial evaluating the effectiveness of a transition programme for adolescents with congenital heart disease in Sweden. A purposive sample of 14 adolescents and 12 parents randomized to the intervention group were interviewed after participation in the programme. Data were analysed deductively and inductively in NVivo v12.Results: Experiences of participation in the transition programme were generally positive. Meeting a transition coordinator trained in person-centred care and adolescent health and embarking on an educational process based on the adolescents' prerequisites in combination with peer support were considered key change mechanisms. However, support to parents were not sufficient for some participants, resulting in ambivalence about changing roles and the unmet needs of parents who required additional support.Conclusions: Participants experienced increased empowerment in several dimensions of this construct, thus demonstrating that the transition programme was largely implemented as intended and the evidence-based behaviour-change techniques used proved effective in reaching the outcome. These findings can inform future implementation of transition programmes and illuminate challenges associated with delivering a complex intervention for adolescents with chronic conditions. [ABSTRACT FROM AUTHOR]

Objective To compare mortality risk over up to 14 years of follow-up in methotrexate-refractory patients with early RA randomized to a strategy starting with addition of infliximab vs addition of SSZ and HCQ. Methods Data was from the two-arm, parallel, randomized, active-controlled, open-label Swefot trial in which patients with early RA (symptom duration <1 y) were recruited from 15 rheumatology clinics in Sweden (2002–2005). Patients who did not achieve low disease activity after 3–4 months of MTX were randomized to addition of infliximab (n  = 128) or SSZ and HCQ (n  = 130). Participants were followed until death, emigration, or end of follow-up, whichever came first. Analyses were by intention-to-treat. Results Over an average follow-up of 13 years, there were 13 and 16 deaths, respectively [8.8 vs 10.6 deaths per 1000 person-years; mortality hazard ratio 1.2 (95% CI: 0.6, 2.5); P  =0.62]. The 1-year mortality was 0.8% in both treatment arms, the 5-year mortality was 2.3% for the infliximab arm compared with 1.5% for the conventional combination treatment arm, while the 10-year mortality was 7.8% and 7.7%, respectively. After 5 years, ∼50% of patients in the conventional combination therapy arm had switched to biologic treatment, and 50% in the biologic arm had discontinued treatment with a biologic DMARD. Conclusion No difference in mortality risk could be observed over up to 14 years of follow-up between treatment strategy groups. At 5 years (3 years after trial cessation), 50% of patients remained on their assigned therapy, reflecting that DMARD combination is an adequate treatment strategy in 50% of patients. Trial registration clinicaltrials.gov, identifier: NCT00764725. [ABSTRACT FROM AUTHOR]

Background: Evidence for the effect of minimal acupuncture in infants with colic is limited. Aim: To compare the effect of standardized minimal acupuncture, individualized acupuncture (where traditional acupuncture points were chosen according to the infant's symptoms) and no acupuncture on objective measures of stooling, feeding and sleeping in infants with colic (based on diaries) and perceived changes in these parameters (based on parental questionnaires). Methods: This was a secondary analysis of a multicentre randomized controlled three-armed trial conducted in four counties in Sweden between January 2013 and May 2015 (ACU-COL). The effect on crying has already been published and showed a decrease in crying time for the acupuncture groups. Infants, 2–8 weeks old, who cried and fussed for more than 3 h/day for more than 3 days/week, and thereby fulfilled the criteria for infantile colic, received four extra visits to their ordinary child health centre. The infants (n = 147) were randomly allocated via a computer-generated list to standardized minimal acupuncture at LI4 for 5 s (group A, n = 48), semi-standardized individual acupuncture with a maximum of five insertions for up to 30 s (group B, n = 49), or no acupuncture (group C, n = 48). The parents and the ordinary staff were blinded. Data were collected using: (1) diaries at baseline, during the two intervention weeks and 1-week follow-up; and (2) questionnaires with quantitative and qualitative components used at the second and fourth visits and during a follow-up telephone call. Outcomes were the changes in frequency of stooling and in hours of sleep per day. Results: There were no differences between groups for stooling, feeding, or sleeping at any time point according to data from the diaries. At the follow-up phone call, more parents in groups A and B (compared to group C) perceived that feeding and sleep had changed and that the symptoms of colic had improved. [ABSTRACT FROM AUTHOR]

Objective: In this study, we evaluate the efficacy of outpatient individual cognitive behavioral therapy for young adults (CBT-YA) and combined family/individual therapy for young adults (FT-YA) for anorexia nervosa (AN). Method: Participants (aged 17–24 years) with AN in Sweden were recruited and assigned to 18 months of CBT-YA or FT-YA. Treatment efficacy was assessed primarily using BMI, presence of diagnosis, and degree of eating-related psychopathology at post-treatment and follow-up. Secondary outcomes included depression and general psychological psychopathology. The trial was registered at , ISRCTN (25181390). Results: Seventy-eight participants were randomized, and seventy-four of them received allocated treatment and provided complete data. Clinical outcomes from within groups resulted in significant improvements for both groups. BMI increased from baseline (CBT-YA 16.49; FT-YA 16.54) to post-treatment (CBT-YA 19.61; FT-YA 19.33) with high effect sizes. The rate of weight restoration was 64.9% in the CBT-YA group and 83.8% in the FT-YA group. The rate of recovery was 76% in both groups at post-treatment, and at follow-up, 89% and 81% had recovered in the CBT-YA and FT-YA groups respectively. Conclusions: Outpatient CBT-YA and FT-YA appear to be of benefit to young adults with AN in terms of weight restoration and reduced eating disorder and general psychopathology. [ABSTRACT FROM AUTHOR]

Alcohol is one of the leading risk factors for global disease burden and overconsumption leads to a wide variety of negative consequences in everyday life. Digital interventions have shown small positive effects in contributing to reductions in problematic use. Specific research on smartphone apps is sparse and the few studies published indicate effects ranging from negative or null to small or moderate. TeleCoach™, a web-based skills training smartphone app, has shown positive effects in non-treatment-seeking university students with excessive drinking. This pilot trial aimed to evaluate app effects in a sample of internet help-seekers from the general population in Sweden. A total of 89 participants were recruited via online advertisement. Following baseline assessment for hazardous use, they were randomized to TeleCoach or a web-based control app offering brief information and advice regarding problematic alcohol use. The primary outcome was number of standard drinks per week; secondary outcomes included drinking quantity and frequency, binge drinking and blood alcohol count measures as well as app user data and comorbidity related to depression, anxiety, and drug use. Analysis of baseline and 6-week follow-up outcomes showed significant within-group effects on alcohol consumption but no significant between-group differences. Effect sizes for the within-group changes in the primary outcome over time were significant [ F (1, 55)=43.98; p < 0.001], with a Cohen's d of 1.37 for the intervention group and 0.92 for the control group. This difference in effect sizes indicated that continuation of the study as a large randomized, controlled trial with up to 1,000 participants could be worthwhile. Clinical Trial Registration: www.ClinicalTrials.gov , identifier NCT03696888. [ABSTRACT FROM AUTHOR]

Background: Treatment with beta-blockers is currently recommended after myocardial infarction (MI). The evidence relies on trials conducted decades ago before implementation of revascularization and contemporary medical therapy or in trials enrolling patients with heart failure or reduced left ventricular ejection fraction (LVEF ≤ 40%). Accordingly, the impact of beta-blockers on mortality and morbidity following acute MI in patients without reduced LVEF or heart failure is unclear.Methods/design: The Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK) is a prospective, randomized, controlled, open-label, non-blinded endpoint clinical trial designed to evaluate the efficacy of beta-blocker treatment in post-MI patients in the absence of reduced LVEF or heart failure. We will randomize 3570 patients will be randomized within 14 days of index MI to beta-blocker or control for a minimum of 2 years. The primary endpoint is a composite of all-cause mortality, recurrent MI, acute decompensated heart failure, unstable angina pectoris, or stroke. The primary composite endpoint will be assessed through locally reported and adjudicated endpoints supplemented by linkage to the Danish national registers. A number of secondary endpoints will be investigated including patient reported outcomes and cardiovascular mortality. Data from similar ongoing trials in Norway and Sweden will be pooled to perform an individual patient data meta-analysis.Discussion: DANBLOCK is a randomized clinical trial investigating the effect of long-term beta-blocker therapy after myocardial infarction in patients without heart failure and reduced LVEF. Results from the trial will add important scientific evidence to inform future clinical guidelines.Trial Registration: Clinicaltrials.gov, NCT03778554. Registered on 19 December 2018. European Clinical Trials Database, 2018-002699-42, registered on 28 September 2018. [ABSTRACT FROM AUTHOR]

Background and purpose: We investigated 952 subjects undergoing diagnostic lumbar puncture (LP) to study the effects of needle size, needle design and stylet reinsertion on the risk of post‐dural puncture headache (PDPH). Methods: This randomized double‐blind study was performed at Umeå University Hospital in Sweden during 2013–2018. Subjects were randomly assigned one of three needles [22 gauge (G) atraumatic, 25G atraumatic and 25G cutting] and stylet reinsertion before needle withdrawal or not. The main outcome measure was PDPH assessed by standardized telephone interview(s) 5 days after the LP, repeated until headache cessation. We used logistic regression to calculate odds ratios (ORs) with 95% confidence intervals (CI) for PDPH. Results: The mean (SD) age was 51.1 (16.7) years and 53.6% were females. The smaller bore (25G) atraumatic needle incurred a lower risk of headache compared with the larger bore (22G) atraumatic needle [22.0% (69/314) vs. 30.2% (98/324); OR, 0.65; 95% CI, 0.45–0.93] and compared with the cutting needle [32.8% (103/314); OR, 0.58; 95% CI, 0.40–0.82]. Reinserting the stylet before needle withdrawal did not reduce the risk of headache. Conclusions: These data suggest that a 25G atraumatic needle is superior to a larger atraumatic needle, and to a same‐sized cutting needle, in preventing PDPH after diagnostic LP. In contrast to one earlier report, this study did not find that stylet reinsertion was effective in preventing PDPH. This study provides class I evidence that a small atraumatic needle decreases the risk of PDPH and that stylet reinsertion does not influence PDPH risk. [ABSTRACT FROM AUTHOR]

Aims: Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx.Methods: A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years.Conclusion: The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx. [ABSTRACT FROM AUTHOR]

Youth is a period in life when the risk of violence victimization is high and association between victimization and ill health is well established. Youth rarely reveal violence victimization to health professionals if not directly asked but favor health professionals asking about victimization. The study's primary aim was to examine health outcomes in young women being routinely asked about violence victimization and offered subsequent support, compared with controls, at 12-month follow-up. Secondary aims were to examine to what extent routine inquiry altered the consultation and re-victimization rates during the study period. A randomized controlled intervention study was conducted at Swedish youth health centers. Participants assigned to the intervention group were asked structured questions about violence. Victimized participants received empowering strategies and were offered further counseling. Participants in the control group completed questionnaires about victimization after the visit. Both groups answered questions about sociodemographics and health, constructed from validated instruments. A questionnaire was administered to all participants 12 months after baseline. Of 1,445 eligible young women, 1,051 (73%) participated, with 54% of the participants completing the 12-month follow-up. Lifetime violence victimization was reported by 53% in the intervention group and 60% in the control group, ns. There were no significant differences in health outcomes, between baseline and 12-month follow-up, within either group or between groups. Re-victimization rates were 16% in the intervention group and 12% in the control group, ns. Of victimized young women in the intervention group, 14% wanted and received further counseling. Routine inquiry about violence victimization and empowering strategies were feasible within ordinary consultations at youth health centers but did not demonstrate improved health outcomes at 12-month follow-up compared with controls. Questions about violence led to a high degree of disclosure, and 14% of victimized young women in the intervention group received further counseling as a result. [ABSTRACT FROM AUTHOR]

Background: The results of germline genetic testing for hereditary cancer are of importance not only to the patients under investigation but also to their genetic at-risk relatives. Standard care is to encourage the proband (first family member under investigation) to pass on this risk information to the relatives. Previous research suggests that with family-mediated disclosure, only about a third of at-risk relatives contact health care to receive genetic counselling. In some studies, complementing family-mediated risk disclosure with healthcare-assisted risk disclosure almost doubles the uptake of genetic counselling in at-risk relatives. In this study, we evaluate healthcare-assisted direct letters to relatives at risk of hereditary cancer syndromes in a randomized controlled trial., Methods: Probands are recruited from Swedish outpatient cancer genetics clinics to this two-arm randomized controlled trial. The study recruits probands with either a pathogenic variant in a cancer susceptibility gene (BRCA1, BRCA2, PALB2, MLH1, MSH2, MSH6, PMS2) or probands with familial breast and colorectal cancer based on clinical and pedigree criteria. In both arms, probands receive standard care, i.e., are encouraged and supported to pass on information to relatives. In the intervention arm, the proband is also offered to have direct letters sent to the at-risk relatives. The primary outcome measure is the proportion of at-risk relatives contacting a Swedish cancer genetics clinic within 12 months of the proband receiving the test results., Discussion: This paper describes the protocol of a randomized controlled clinical trial evaluating a healthcare-assisted approach to risk disclosure by offering the probands to send direct letters to their at-risk relatives. The results of this study should be informative in the future development of risk disclosure practices in cancer genetics clinics., Trial Registration: ClinicalTrials.gov. Identifier NCT04197856 (pre-trial registration on December 13, 2019). Also registered at the website "RCC Cancerstudier i Sverige" as study #86719., (© 2023. The Author(s).)

Introduction: Many depressed patients do not achieve remission with available treatments. Anhedonia is a common residual symptom associated with treatment resistance as well as low function and quality of life. There are currently no specific and effective treatments for anhedonia. Some trials have shown that dopamine agonist pramipexole is efficacious for treating depression, but more data is needed before it could become ready for clinical prime time. Given its mechanism of action, pramipexole might be a useful treatment for a depression subtype characterised by significant anhedonia and lack of motivation-symptoms associated with dopaminergic hypofunction. We recently showed, in an open-label pilot study, that add-on pramipexole is a feasible treatment for depression with significant anhedonia, and that pramipexole increases reward-related activity in the ventral striatum. We will now confirm or refute these preliminary results in a randomised controlled trial (RCT) and an open-label follow-up study., Methods and Analysis: Eighty patients with major depression (bipolar or unipolar) or dysthymia and significant anhedonia according to the Snaith Hamilton Pleasure Scale (SHAPS) are randomised to either add-on pramipexole or placebo for 9 weeks. Change in anhedonia symptoms per the SHAPS is the primary outcome, and secondary outcomes include change in core depressive symptoms, apathy, sleep problems, life quality, anxiety and side effects. Accelerometers are used to assess treatment-associated changes in physical activity and sleep patterns. Blood and brain biomarkers are investigated as treatment predictors and to establish target engagement. After the RCT phase, patients continue with open-label treatment in a 6-month follow-up study aiming to assess long-term efficacy and tolerability of pramipexole., Ethics and Dissemination: The study has been approved by the Swedish Ethical Review Authority and the Swedish Medical Products Agency. The study is externally monitored according to Good Clinical Practice guidelines. Results will be disseminated via conference presentations and peer-reviewed publications., Trial Registration Number: NCT05355337 and NCT05825235., Competing Interests: Competing interests: MA has received speaking honorarium from H. Lundbeck AB. DL has received speaking honorarium from H. Lundbeck AB and Janssen-Cilag AB, (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background: Although mindfulness‐based group therapies (MGTs) for depressive, anxiety or stress and adjustment disorders are promising, there is a substantial lack of knowledge regarding the long‐term improvements after such therapies in these common psychiatric disorders. Methods: Two hundred and fifteen patients were randomized in a randomized clinical trial (RCT) (ClinicalTrials.gov ID: NCT01476371) conducted in 2012 at 16 primary healthcare centres in southern Sweden. The patients were randomized to MGT or treatment as usual (TAU) and completed four psychometric self‐rated scales after 8 weeks of treatment. Approximately 12 months after the completion of the 8‐week treatment, the same scales were repeated. Ordinal and generalized linear‐mixed models, adjusted for cluster effects, were used for the analysis. Results: For all four psychometric scales (MADRS‐S [Montgomery‐Åsberg Depression Rating Scale‐S], HADS‐D, HADS‐A [Hospital Anxiety and Depression Scale A and D] and PHQ‐9 [Patient Health Questionnaire‐9]) the scores at the 1‐year follow‐up were significantly improved (all P values <0.001) in both groups. Furthermore, there were no significant differences between the MGT and TAU in the psychometric scores at the 1‐year follow‐up. Conclusions: To the best of our knowledge, this is the first RCT comparing the long‐term improvements after MGT with TAU. Although it cannot be excluded that our findings are a result of the natural course of common psychiatric disorders or other factors, they suggest a long‐term positive improvement after both MGT and TAU. [ABSTRACT FROM AUTHOR]

Purpose: Head and neck cancer and its treatment deteriorate quality of life, but symptoms improve with person-centred care. We examined the cost-effectiveness of a person-centred care intervention versus standard medical care.Methods: In this randomized clinical trial of a person-centred intervention, patients were planned for outpatient oncology treatment in a Swedish university hospital between 2012 and 2014 and were followed during 1 year. Annual healthcare costs were identified from medical records and administrative register data. Productivity costs were calculated from reported sick leave. Health-related quality of life was collected using the EuroQol Group's five-dimension health state questionnaire.Results: Characteristics were similar between 53 patients in the intervention group and 39 control patients. The average total cost was Euro (EUR) 55,544 (95% confidence interval: EUR 48,474-62,614) in the intervention group and EUR 57,443 (EUR 48,607-66,279) among controls, with similar health-related quality of life.Conclusions: This person-centred intervention did not result in increased costs and dominated the standard medical care.Trial Registration: ClinicalTrials.gov (registration number: NCT02982746). [ABSTRACT FROM AUTHOR]

Objective: This pre-planned secondary analysis of geriatric interdisciplinary home rehabilitation, which was initially found to shorten the postoperative length of stay in hospital for older individuals following hip fracture, investigated whether such rehabilitation reduced the numbers of complications, readmissions, and total days spent in hospital after discharge during a 12-month follow-up period compared with conventional geriatric care and rehabilitation. Design: Randomized controlled trial. Setting: Geriatric department, participants' residential care facilities, and ordinary housing. Subjects: Individuals aged ⩾70 years with acute hip fracture (n = 205) were included. Intervention: Geriatric interdisciplinary home rehabilitation was individually designed and aimed at early discharge with the intention to prevent, detect, and treat complications after discharge. Main measures: Complications, readmissions, and days spent in hospital were registered from patients' digital records and interviews conducted during hospitalization and at 3- and 12-month follow-up visits. Results: No significant difference in outcomes was observed. Between discharge and the 12-month follow-up, among participants in the geriatric interdisciplinary home rehabilitation group (n = 106) and control group (n = 93), 57 (53.8%) and 44 (47.3%) had complications (P = 0.443), 46 (43.4%) and 38 (40.9%) fell (P = 0.828), and 38 (35.8%) and 27 (29.0%) were readmitted to hospital (P = 0.383); the median total days spent in hospital were 11.5 and 11.0 (P = 0.353), respectively. Conclusion: Geriatric interdisciplinary home rehabilitation for older individuals following hip fracture resulted in similar proportions of complications, readmissions, and total days spent in hospital after discharge compared with conventional geriatric care and rehabilitation. [ABSTRACT FROM AUTHOR]

Millions of children are victims of child abuse world-wide. Consequences include long-term health impacts and large societal costs. Parent training is promising to prevent abuse, but challenges with motivation and attrition must be overcome to reach parents in need. To assess the effectiveness and acceptability of Safer Kids, a cognitive behavioral therapy-based parenting program delivered immediately after a report of child abuse. Safer Kids is used within the Child Welfare Services (CWS) in Sweden but has never been evaluated in an RCT. In total, 112 families with children 2–12 years referred to the Swedish CWS for physical or emotional child abuse participated. Families were randomized to Safer Kids or intervention as usual (IAU). Data from parents, children and CWS were analyzed with multilevel and survival analyses. Primary outcomes were parent-rated child abuse potential and re-reports of abuse. Secondary outcomes were child abuse risk factors and treatment satisfaction. Data 4 and 7 months from baseline were available for 96 % of the families. All except one family (98 %) who started Safer Kids completed the program. Both groups improved from baseline to follow-ups on most effectiveness outcomes. The changes were not statistically different between groups. Parents and social workers were more satisfied with Safer Kids than IAU. Short manualized parenting programs can be a way to reach parents reported for child abuse with support. Safer Kids is a viable option to the CWS's standard interventions, as it was equally effective and slightly better accepted than IAU. • Safer Kids is a brief parenting program delivered after a report of child abuse. • Safer Kids was compared to intervention as usual within the Child Welfare Services. • Both groups improved from baseline to follow ups. • Parents and social workers were more satisfied with Safer Kids. • Safer Kids is a viable option to standard interventions. [ABSTRACT FROM AUTHOR]

Objective: To evaluate if an internet-delivered parent training program is noninferior to its group-delivered counterpart in reducing child disruptive behavior problems (DBP)., Method: This noninferiority randomized clinical trial enrolled families seeking treatment in primary care in Stockholm, Sweden, for DBP in a child 3-11 years of age. Participants were randomized to internet-delivered (iComet) or group-delivered (gComet) parent training. The primary outcome was parent-rated DBP. Assessments were made at baseline and 3, 6, and 12 months. Secondary outcomes included child and parent behaviors and well-being and treatment satisfaction. The noninferiority analysis was determined by a one-sided 95% CI of the mean difference between gComet and iComet using multilevel modeling., Results: This trial included 161 children (mean age 8.0); 102 (63%) were boys. In both intention-to-treat and per-protocol analyses, iComet was noninferior to gComet. There were small differences in between-group effect sizes (d = -0.02 to 0.13) on the primary outcome with the upper limit of the one-sided 95% CI below the noninferiority margin at 3-, 6-, and 12-month follow-up. Parents were more satisfied with gComet (d = 0.49, 95% CI [0.26, 0.71]). At 3-month follow-up, there were also significant differences in treatment effect on attention-deficit/hyperactivity disorder symptoms (d = 0.34, 95% CI [0.07, 0.61]) and parenting behavior (d = 0.41, 95% CI [0.17, 0.65]) favoring gComet. At 12-month follow-up, there were no differences in any outcomes., Conclusion: Internet-delivered parent training was noninferior to group-delivered parent training in reducing child DBP. The results were maintained at 12-month follow-up. This study supports internet-delivered parent training being used as an alternative to group-delivered parent training in clinical settings., Clinical Trial Registration Information: Randomized Controlled Trial of Comet via the Internet or in Group Format; https://www., Clinicaltrials: gov/; NCT03465384., (Copyright © 2023 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.)

Aim: We investigated the eligibility for vericiguat in a real-world heart failure (HF) population based on trial, guideline and label criteria., Methods and Results: From the Swedish HF registry, 23 573 patients with HF with reduced ejection fraction (HFrEF) enrolled between 2000 and 2018, with a HF duration ≥6 months, were considered. Eligibility for vericiguat was calculated based on criteria from (i) the Vericiguat Global Study in Subjects with Heart Failure and Reduced Ejection Fraction (VICTORIA) trial; (ii) European and American guidelines on HF; (iii) product labelling according to the Food and Drug Administration and European Medicines Agency. Estimated eligibility for vericiguat in the trial, guidelines, and label scenarios was 21.4%, 47.4%, and 47.4%, respectively. Prior HF hospitalization within 6 months was the criterion limiting eligibility the most in all scenarios (met by 49.1% of the population). In the trial scenario, other criteria meaningfully limiting eligibility were elevated N-terminal pro-B-type natriuretic peptide levels and nitrate use. In all scenarios, eligibility was higher among patients hospitalized for HF at baseline (44.3% vs. 21.4% [trial scenario] and 97.3% vs. 47.4% [guideline/label scenarios] for hospitalized vs. non-hospitalized patients). Overall, eligible patients were older, had more severe HF, more comorbidities, and consequently higher cardiovascular mortality and HF hospitalization rates compared with ineligible patients across all scenarios., Conclusion: In a large and contemporary real-world HFrEF cohort, we estimated that 21.4% of patients would be eligible for vericiguat according to the VICTORIA trial selection criteria, 47.4% based on guidelines and labelling. Eligibility for vericiguat translated into the selection of a population at high risk of morbidity/mortality., (© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Abstract Background People typically seek primary health care for daytime symptoms and impairments they experience in association with their insomnia. However, few studies address the question of whether insomnia treatment can improve such symptomatology. Objectives To investigate whether a nurse-led group treatment program, based on the techniques of cognitive behavioral therapy for insomnia (CBT-I), improved daytime symptomatology in primary care patients with insomnia. Outcomes Fatigue (Fatigue Severity Scale [FSS]; main outcome), mood (General Health Questionnaire and Montgomery-Asberg Depression Rating Scale), health-related quality of life (Short-Form Health Survey), general daytime functioning, specific daytime symptoms (individual items from the Insomnia Severity Index and Uppsala Sleep Inventory), and dysfunctional beliefs (Dysfunctional Beliefs and Attitudes about Sleep). Design A randomized controlled trial including baseline and post-treatment assessment and a 1-year post-treatment follow-up of the intervention group. Settings Seven primary health care centers (Stockholm, Sweden). Participants One hundred and sixty-five primary care patients who meet the criteria for insomnia disorder (mean age 54 years, SD 16). Most were women (73%). Exclusion criteria: severe untreated illness, bipolar disorder, current stressful life event, night shift work, and untreated sleep disorder other than insomnia. Methods Data came from a randomized controlled trial of a 10-week nurse-led group treatment for insomnia based on CBT-I (n = 90). The control condition was treatment as usual (n = 75). In accordance with intention-to-treat principles, analyses included data on patients who completed baseline assessments (intervention n = 82, and control group n = 71; post-treatment dropout rate 20%). Fifty-four patients were included in the 1-year follow-up. Results Fatigue severity improved significantly more (p < 0.001) in the intervention than in the control group (intervention, total FSS score 37.2 [SD 11.9] to 31.0 [SD 13.4] vs. control 35.9 [SD 12.1] to 35.7 [SD 12.8]). This was true also for measurements on mood (psychological distress and depressive symptoms), health-related quality of life (mental functioning), general daytime functioning, specific daytime symptoms (worry about sleep, sleepiness, bodily tiredness, and difficulty concentrating) and dysfunctional beliefs. All improvements were maintained one year after group treatment. Conclusions Many aspects of the daytime symptomatology of insomnia were improved via nurse-led group treatment based on CBT-I in primary health care. [ABSTRACT FROM AUTHOR]

Objective: To compare vaginal misoprostol treatment with expectant management in early non-viable pregnancy with vaginal bleeding with regard to complete evacuation of the uterine cavity within 10 days after randomization.Methods: This was a parallel randomized controlled, open-label trial conducted in Skåne University Hospital, Sweden. Patients with anembryonic pregnancy or early fetal demise (crown-rump length ≤ 33 mm) and vaginal bleeding were randomly allocated to either expectant management or treatment with a single dose of 800 μg misoprostol administered vaginally. Patients were evaluated clinically and by ultrasound until complete evacuation of the uterus was achieved (no gestational sac in the uterine cavity and maximum anteroposterior diameter of the intracavitary contents < 15 mm as measured by transvaginal ultrasound on midsagittal view). Follow-up visits were planned at 10, 17, 24 and 31 days. Dilatation and evacuation (D&E) was recommended if miscarriage was not complete within 31 days, but was performed earlier at patient's request, or if there was excessive bleeding as judged clinically. Analysis was by intention to treat. The main outcome measure was number of patients with complete miscarriage without D&E ≤ 10 days.Results: Ninety-four patients were randomized to misoprostol treatment and 95 to expectant management. After exclusion of three patients and withdrawal of consent by two patients in the expectant management group, 90 women were included in this group. Miscarriage was complete ≤ 10 days in 62/94 (66%) of the patients in the misoprostol group and in 39/90 (43%) of those in the group managed expectantly (risk difference (RD) = 23%; 95% CI, 8-37%). At 31 days, the corresponding figures were 81/94 (86%) and 55/90 (61%) (RD = 25%; 95% CI, 12-38%). Two patients from each group underwent emergency D&E because of excessive bleeding and one of these in each group received blood transfusion. The number of patients undergoing D&E at their own request was higher in the expectantly managed group, 15/90 (17%) vs 3/94 (3%) in the misoprostol group (RD = 14%; 95% CI, 4-23%), as was the number of patients making out-of-protocol visits, 50/90 (56%) vs 27/94 (29%) (RD = 27%; 95% CI, 12-40%). Compared with the expectant management group, more patients in the misoprostol group experienced pain (71/77 (92%) vs 91/91 (100%); RD = 8%; 95% CI, 1-17%) and used painkillers (59/77 (77%) vs 85/91 (93%); RD = 17%; 95% CI, 5-29%). No major side effect was reported in any group.Conclusions: In women with early non-viable pregnancy and vaginal bleeding, misoprostol treatment is more effective than is expectant management for complete evacuation of the uterus. Both methods are safe but misoprostol treatment is associated with more pain than is expectant management. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Background Insomnia is a common health problem, and most people who seek help for insomnia consult primary care. In primary care, insomnia treatment typically consists of hypnotic drugs, although cognitive behavioral therapy for insomnia is the recommended treatment. However, such treatment is currently available to few primary care patients. Objectives To evaluate the effects of a group treatment program for insomnia led by nurses in primary care. Outcomes were the Insomnia Severity Index, a 2-week sleep diary, and a questionnaire on frequency of hypnotic drug use. Design A randomized controlled trial with pre- and post-treatment assessment and a 1-year post-treatment follow-up of the intervention group. Settings Routine primary health care; 7 primary care centers in Stockholm, Sweden. Participants Patients consulting primary care for insomnia were assessed for eligibility. To be included, patients had to have insomnia disorder and be 18 years or older. Patients were excluded if they if they worked night shifts or had severe untreated somatic and/or mental illness, bipolar disorder, or untreated sleep disorder other than insomnia. One-hundred and sixty-five patients 20 to 90 years were included. Most were women, and many had co-existing somatic and/or mental health problems. The post-treatment dropout rate was 20%. Methods The intervention was a nurse-led group treatment for insomnia based on the techniques of cognitive behavioral therapy for insomnia. The nurses had 2 days of training in how to deliver the program. Ninety patients were randomized to the intervention and 75 to the control group (treatment as usual). Data from 82 in the intervention and 71 in the control group were analyzed in accordance with intention-to-treat principles. Fifty-four of the 72 in the intervention group who participated in the group treatment program were followed up after 1 year. Results Mean Insomnia Severity Index score decreased significantly from 18.4 to 10.7 after group treatment but remained unchanged after treatment as usual (17.0 to 16.6). The effect size was large (1.23). Group treatment also resulted in significant improvements in all sleep diary variables (sleep onset latency, total sleep time, time awake after sleep onset, number of awakenings, and sleep quality). It also reduced hypnotic drug use. Improvements were maintained 1-year post-treatment. Conclusions Patients with insomnia can be treated successfully with a nurse-led group treatment program in primary health care. The results support implementation of the treatment program, particularly given the need for increased access to non-pharmacological insomnia treatments. [ABSTRACT FROM AUTHOR]

Background: Traditional obesity prevention programs are time- and cost-intensive. Mobile phone technology has been successful in changing behaviors and managing weight; however, to our knowledge, its potential in young children has yet to be examined. Objective: We assessed the effectiveness of a mobile health (mHealth) obesity prevention program on body fat, dietary habits, and physical activity in healthy Swedish children aged 4.5 y. Design: From 2014 to 2015, 315 children were randomly assigned to an intervention or control group. Parents in the intervention group received a 6-mo mHealth program. The primary outcome was fat mass index (FMI), whereas the secondary outcomes were intakes of fruits, vegetables, candy, and sweetened beverages and time spent sedentary and in moderate-to-vigorous physical activity. Composite scores for the primary and secondary outcomes were computed. Results: No statistically significant intervention effect was observed for FMI between the intervention and control group (mean ± SD: -0.23 ± 0.56 compared with -0.20 ± 0.49 kg/m²). However, the intervention group increased their mean composite score from baseline to follow-up, whereas the control group did not (+0.36 ± 1.47 compared with -0.06 ± 1.33 units; P = 0.021). This improvement was more pronounced among the children with an FMI above the median (4.11 kg/m²) (P = 0.019). The odds of increasing the composite score for the 6 dietary and physical activity behaviors were 99% higher for the intervention group than the control group (P = 0.008). Conclusions: This mHealth obesity prevention study in preschool-aged children found no difference between the intervention and control group for FMI. However, the intervention group showed a considerably higher postintervention composite score (a secondary outcome) than the control group, especially in children with a higher FMI. Further studies targeting specific obesity classes within preschool-aged children are warranted. This trial was registered at clinicaltrials.gov as NCT02021786. [ABSTRACT FROM AUTHOR]

Background: The aim of the study was to evaluate the feasibility and effects of an internet-based information and self-help program with therapist contact for parents of children and adolescents with burns. The program aimed to reduce parents' symptoms of general and posttraumatic stress.Methods: Participants were parents of children treated for burns between 2009-2013 at either of the two specialized Swedish Burn centers. Sixty-two parents were included in a two-armed, randomized controlled trial with a six-week intervention group and a wait-list control group, including a pre and post-assessment, as well as a 3 and 12-month follow-up. The intervention contained psychoeducation, exercises and homework assignments, and the intervention group received weekly written feedback from a therapist. The main outcome was stress (post-traumatic stress, general stress and parental stress).Results: The program had a beneficial effect on posttraumatic stress in the short term, but did not affect general stress or parental stress. The parents rated the program as being informative and meaningful, but some of them thought it was time-consuming.Conclusion: The program has the potential to support parents of children with burns. The intervention is easily accessible, cost-effective and could be implemented in burn care rehabilitation. [ABSTRACT FROM AUTHOR]

Objective To analyze the age- and trial-specific effects of the breast cancer screening trials with mammography in Malmö, Stockholm, and Göteborg. Methods The original trial files were linked to the Swedish Cancer and Cause of Death Registers to obtain date of breast cancer diagnosis and date and cause of death. Relative risks and 95% confidence intervals were calculated using the evaluation model (only breast cancers diagnosed between date of randomization and date when the first screening round of the control group was completed were included in the analysis). Results Women aged 40–70 at randomization in the Malmö I and II, Stockholm, and Göteborg trials were followed-up for an average of 30, 22, 25, and 24 years, respectively. The overview of all trials resulted in a significant decrease of 15% in breast cancer mortality. The variation by consecutive 10-year age group at randomization was small—from 21% in the age group 40–49 to 11% in the age group 50–59. After adjustment for age, there was a significant reduction in breast cancer mortality in the Göteborg trial (26%), and a non-significant reduction in the Malmö I and II and Stockholm trials (12%, 15%, and 5.8%, respectively). Conclusions The overview showed a 15% significant relative reduction in breast cancer mortality due to invitation to mammography screening. Heterogeneity in age, trial time, attendance rates, and length of screening intervals may have contributed to the variation in effect between the trials. [ABSTRACT FROM AUTHOR]

Background: Impaired emotional well-being has detrimental effects on health outcomes in patients with chronic heart failure (CHF). Aims: To evaluate a nurse-led Coping Effectiveness Training (CET) group intervention for patients with CHF. It was hypothesized that CET would increase emotional well-being (primary outcome) and health-related quality (HRQoL) of life and improve clinical outcomes. Furthermore, changes in appraisal and coping as mediators of the intervention effect were examined. Methods: Participants were randomized to either control group (n=51) receiving standard health care or CET intervention group (n=52). Self-assessments of positive affect, negative affect, depression, anxiety, HRQoL, illness perception, coping strategies and social support were performed pre- and post-intervention and after six weeks, six months and 12 months. Time to death and hospitalizations were measured during the entire follow-up (median 35 months, interquartile range 11 months). Results: No significant improvements for emotional well-being and HRQoL in the intervention group compared with the control group were found. After excluding patients with clinical anxiety and depression at baseline the intervention group had significantly lower negative affect (p = 0.022). There were no significant differences regarding cardiovascular events between the groups. The intervention group had greater sense of control over their illness in the short-term (p = 0.036). Conclusion: CET intervention was found to increase sense of control over the illness in the short term. Psychosocial support programmes, like CET, for patients with CHF is currently lacking evidence for implementing in clinical practice. However, the results provide a basis for future studies with a modified CET intervention design and increased study size. [ABSTRACT FROM AUTHOR]

Rationale: Blood pressure reduction in response to antihypertensive agents is less for patients with obstructive sleep apnea (OSA). Increased sympathetic and inflammatory activity, as well as alterations in the renin-angiotensin-aldosterone system, may play a role in this context.Objectives: To address the cardiovascular mechanisms involved in response to an angiotensin II receptor antagonist, losartan, and continuous positive airway pressure (CPAP) as add-on treatment for hypertension and OSA.Methods: Newly diagnosed hypertensive patients with or without OSA (allocated in a 2:1 ratio for OSA vs. no OSA) were treated with losartan 50 mg daily during a 6-week two-center, open-label, prospective, case-control, parallel-design study. In the second 6-week, sex-stratified, open-label, randomized, parallel-design study, all subjects with OSA continued to receive losartan and were randomly assigned to either CPAP as add-on therapy or to no CPAP (1:1 ratio for CPAP vs. no CPAP). Study subjects without OSA were followed in parallel while they continued to take losartan. Blood samples were collected at baseline, after 6 weeks, and after 12 weeks for analysis of renin, aldosterone, noradrenaline, adrenaline, and inflammatory markers.Measurements and Main Results: Fifty-four patients with OSA and 35 without OSA were included in the first 6-week study. Losartan significantly increased renin levels and reduced aldosterone levels in the group without OSA. There was no significant decrease in aldosterone levels among patients with OSA. Add-on CPAP treatment tended to lower aldosterone levels, but reductions were more pronounced in measures of sympathetic activity. No significant changes in inflammatory markers were observed following treatment with losartan and CPAP.Conclusions: Hypertensive patients with OSA responded to losartan treatment with smaller reductions in aldosterone compared with hypertensive patients without OSA. Sympathetic system activity seemed to respond primarily to add-on CPAP treatment in patients with newly discovered hypertension and OSA. Clinical trial registered with www.clinicaltrials.gov (NCT00701428). [ABSTRACT FROM AUTHOR]

Purpose: A multifunctional diet (MFD) was previously shown to reduce blood lipids, CRP and blood pressure in a 4-week intervention under weight-maintenance conditions. Here, MFD effects were evaluated in an 8-week intervention with no restriction for weight changes. Methods: Healthy subjects consumed MFD (23 subjects) or a control diet (CD) devoid of the functional components (24 subjects) in a 'free-living' randomized controlled experiment. MFD included several functional concepts: low-glycemic-impact meals, antioxidant-rich foods, oily fish, viscous dietary fibers, soybean and whole barley kernel products, almonds and plant stanols. Measured outcomes were fasting blood values of lipids, glucose, insulin, GGT, CRP, HbA1c, PAI-1, GLP-1, GLP-2, body weight, blood pressure and breath hydrogen. Results: At baseline, participants were 51-72 years old, with BMI between 25 and 34 and fasting glycemia ≤ 6.1 mmol/L. Consumption of both diets resulted in similar weight loss after 8 weeks (−4 %; P < 0.001). Compared to baseline, consumption of MFD reduced total serum cholesterol (−26 %; P < 0.0001), LDL cholesterol (−35 %; P < 0.0001), triglycerides (−16 %; P < 0.05), LDL/HDL (−27 %; P < 0.0001) and ApoB/ApoA1 (−15 %; P < 0.0001). There were important net differences between diets, which remained significant after adjustment for body weight. Reduced systolic blood pressure, circulating GGT, HbA1c and insulin concentrations were observed with both MFD and CD with no difference between diets. The Reynolds cardiovascular risk score was decreased by 36 % ( P < 0.0001) with MFD. MFD increased breath hydrogen levels (120 %; P < 0.05). Conclusions: Consumption of MFD decreased blood lipids and improved several other aspects of the cardiometabolic risk profile. This effect was not dependent on weight loss. [ABSTRACT FROM AUTHOR]