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Abstract. Introduction:. Chronic pain affects a wide range of physical and psychological aspects of life for those impacted. Psychosocial treatment approaches may be of support, but outreach is still limited. Objectives:. To evaluate the efficacy of EPIO, an evidence-informed, user-centered digital self-management intervention for people with chronic pain, in a 12-month randomized controlled trial. Methods:. People living with chronic pain (N = 266) were randomized to the EPIO intervention (n = 132) or a usual-care control group (n = 134). The intervention was delivered in a simple blended care model, and outcome measures collected at baseline, 6 months, and 12 months. Generalized linear models for repeated measures were fitted to compare groups over time. Results:. Participants were primarily female (81%), median age 49 years (range 22–78), with heterogeneous pain conditions, and had lived with pain >5 years (77.6%). A mixed linear model with all timepoints included revealed no statistically significant group differences for the primary outcome of pain interference. Significant psychological benefits in favor of the intervention group were however detected for depression (P = 0.022), self-regulatory fatigue (P = 0.024), vitality (P = 0.016), and mental health (P = 0.047). Baseline to 12-month changes showed additional favorable effects for anxiety (between-group mean differences [MDs] = 0.79, P = 0.047), depression (MD = 1.08, P = 0.004), self-regulatory fatigue (MD = 2.42, P = 0.021), pain catastrophizing (MD = 2.62, P = 0.009), and health-related quality of life. Conclusions:. The EPIO program aims to improve outreach of evidence-based pain self-management interventions. Findings demonstrate how using EPIO can lead to sustainable psychological change, enhancing mental health and health-related quality of life for people suffering from pain, providing a chance to live well with the pain.

Abstract Background The transition to motherhood is characterized by physical, psychological, social, and relational changes. Quality of life (QoL) changes substantially during this transition. Higher QoL is associated with social support, essential for coping with the challenges and changes of becoming a mother. An early universal home visiting program (New Families) is developed to strengthen and support families. The study aims to evaluate the impact of New Families on first-time mothers’ QoL and to investigate the association between their QoL, social support, and selected possible predictive factors. Methods A prospective non-randomized controlled study with parallel group design. Child Health Services in five city districts of Oslo were matched in intervention and control groups. First-time mothers were allocated based on the residential area and assessed at pregnancy week 28 (N = 228), six weeks postpartum (N = 184), and three months postpartum (N = 167). Measures of the World Health Organization Quality of Life brief, Perinatal Infant Care Social Support Scale, and background variables were collected from October 2018 to June 2020. Multivariate linear regression models were applied to examine intervention impact and assess associations. Results Our data did not reveal a significant association between New Families intervention and the QoL levels of first-time mothers at three months postpartum. Thus, we analyzed the whole sample together. Emotional support was significantly associated with higher QoL levels in the physical health (B = 0.19, 95%CI [0.04 to 0.34]) and social relationships (B = 0.40, 95%CI [0.20 to 0.60]) domains. Appraisal support was significantly associated with higher QoL levels in the psychological (B = 0.34, 95%CI [0.18 to 0.50]) and environment (B = 0.33, 95%CI [0.19 to 0.48]) domains. QoL levels in pregnancy were significantly associated with QoL levels postpartum, showing small to medium effect size (ES = 0.30 to 0.55), depending on the domain. Conclusions Further research, including qualitative interviews, could provide more insights into the impact of New Families on QoL. A positive association between QoL levels in pregnancy and postpartum suggests that postnatal interventions targeting improved QoL could potentially improve postpartum QoL. Emotional and appraisal support seems beneficial for first-time mothers’ QoL and could be provided and facilitated by public health nurses. Trial registration clinicaltrial.gov NCT04162626.

Abstract Background Insufficient sleep is commonly reported in adolescence and is negatively associated with a wide range of health outcomes. A way to grasp the complicated challenge of how sleep impact different aspects of the adolescents´ everyday life is by examining the relationship between sleep duration in schooldays and weekends on different health-related quality of life (HRQOL) subscales. Furthermore, to expand the understanding of possible underlying mechanisms between sleep and HRQOL, testing for self-efficacy as a possible mediator is of importance. Methods A cross-sectional study was performed among 696 adolescents aged 13–15 years from a school-based setting. All participants completed an electronic survey in their respective classrooms. The survey included demographic data, the School Sleep Habits Survey, the KIDSCREEN-27 questionnaire measuring HRQOL, and the General Perceived Self-Efficacy Scale. Statistical analyses were conducted using SPSS Statistics software including PROCESS macro by Andrew Hayes. Results Our findings revealed overall similar sleep patterns in boys and girls including longer sleep duration in the study sample during weekends (10:09 h) than in schooldays (08:36 h). Regression analyses revealed that sleep duration in schooldays was positively and statistically associated with HRQOL subscales psychological well-being (95% CI [0.44 to 1.33]), autonomy and parents (95% CI [0.12 to 1.06]), school environment (95% CI [0.47 to 1.40]), and self-efficacy (95% CI [0.01 to 0.47]). Sleep duration in weekends revealed no associations with the HRQOL subscales, except for the HRQOL subscale psychological well-being (95% CI [0.09 to 0.85]). Mediation analyses revealed that sleep duration in schooldays explained most of the associations (64 − 75%) in 4 out 5 HRQOL subscales, except in the association with the HRQOL subscale physical well-being revealing an indirect effect of 71.9%. Conclusions This cross-sectional study described sleep among Norwegian adolescents and demonstrated that sleep durations in weekends and schooldays impact HRQOL and self-efficacy, revealing overall better outcome in HRQOL and self-efficacy with sufficient sleep during schooldays. These findings support the regularity of sleep and highlight the importance of sufficient sleep during schooldays, especially in a school-based sample of adolescents.

Abstract Background Patients with inflammatory bowel disease report multiple symptoms, but the relationships among co-occurring symptoms are poorly understood. This study aimed to examine the prevalence of symptoms and explore symptom clusters and possible associations between symptom clusters and socio-demographic and clinical variables in patients newly diagnosed with inflammatory bowel disease. Methods The IBSEN III study is a prospective population-based inception cohort of patients with inflammatory bowel disease. This study used patient data from the three largest hospitals in the study catchment area. The Memorial Symptom Assessment Scale was used to assess the prevalence of symptoms. Symptom clusters were identified using principal component analysis. Possible associations between socio-demographic and clinical variables and symptom cluster membership were estimated using regression analysis. Results Of the 573 patients (age, ≥18 years) diagnosed with inflammatory bowel disease, 350 (61.1%) completed the questionnaire (responders). Eleven symptoms were reported by >50% of the responders. The three most prevalent symptoms were bloating (84%), drowsiness (81%), and lack of energy (81%). Three symptom clusters were identified: psychological (56% of the patients), impaired energy (28%), and physical (16%) clusters. Multinomial regression analysis revealed that vitamin D deficiency was significantly associated with the impaired energy cluster (odds ratio=2.49, 95% confidence interval [1.00-6.2], p=0.05). Conclusions We found high symptom prevalence in patients newly diagnosed with inflammatory bowel disease. Three distinct symptom clusters were identified, and the psychological cluster includes >50% of the patients. Vitamin D deficiency is the only factor associated with cluster membership, namely the impaired energy cluster.

Abstract Background In Ethiopia, little is known about postoperative pain trajectories and possible predictive factors associated with them in patients undergoing surgery following traumatic fractures. Methods This multi-center prospective observational cohort study included surgical candidates for traumatic fractures (n = 218). Worst pain intensity was measured with an 11-point numeric rating scale on the first 4 postoperative days and day of hospital discharge. Growth mixture modeling was used to identify subgroups of patients based on their pain trajectories, and logistic regression models to quantify associations between pain trajectories and demographic, clinical, psychological, and life style factors. Results Two postoperative pain trajectory subgroups were identified: rapid pain relief (48% of included individuals) and consistently high pain (52% of included individuals). Sub-analysis stratified by cause of injury demonstrated that higher preoperative pain was an independent risk factor for consistently high postoperative pain regardless of the patient’s injury type: traffic accident (OR = 1.48, 95% CI 1.23–1.79), machine/tool injury or conflict (OR = 1.58, 95% CI 1.11–2.26), or fall (OR = 1.47, 95% CI 1.08–1.99). Moreover, longer surgical time was a risk factor for consistently high postoperative pain among patients who had a fall-related injury (OR = 1.02, 95% CI 1.00–1.03). In contrast, among patients with a traffic-related injury, receiving a nerve block was a protective factor (OR = 0.19, 95% CI 0.04–0.87) compared with general anesthesia. Conclusion Higher preoperative pain and longer surgical time were associated with a consistently high acute postoperative pain trajectory. Clinicians may use these potentially modifiable factors to identify patients at risk for consistently high pain during the early postoperative period.

Abstract Background Patients with chronic low back pain (LBP) and lumbar disc degeneration are recommended to try out nonsurgical treatment options before surgery. There is need for good nonsurgical alternatives that can be adapted to the patient’s needs and level of function. The aim of this pilot trial was to test study feasibility of a future full randomized controlled trial (RCT) evaluating the feasibility and benefit of the physiotherapy-based Godelieve Denys-Struyf (GDS) muscle and articulation chain treatment for patients with chronic LBP and lumbar disc degeneration referred to surgical assessment in a hospital outpatient clinic. Methods This study is a single-center, two-arm, single-blinded, pilot RCT conducted in a regional hospital in Norway. Patients of age 35–75 years with chronic (> 3 months) LBP and degenerative lumbar disc(s) verified by imaging were included. They filled in a baseline questionnaire prior to randomization, including the Oswestry Disability Index (ODI), numerical rating scale for pain in back and pain in leg, and the EuroQoL 5L. Patients in the control group were free to use treatment as usual. Patients in the intervention group received 8 sessions over a period of 10 to 14 weeks of GDS muscle and articulation chain treatment. Results The recruitment rate was slow, approximately 3/4th of the referred patients met the inclusion criteria, but majority of eligible participants (94%) were willing to participate. A total of 30 patients were randomized into the two groups. The randomization led to skewed distribution of radiating leg pain in the two groups. All participants except one (97%) completed 4 months follow-up. No serious adverse events attributable to the trial treatments were reported. The Oswestry Disability Index (ODI) and leg pain intensity scale were both suitable as primary outcomes in a full trial. The mean change in the ODI score was 8.7 (SD 16.1) points in the GDS arm, whereas there was a minor deterioration in the ODI scores of −3.7 (7.5) points in the control arm. A sample size calculation based on the ODI scores resulted in a number needed to treat of 3. Conclusions A future full RCT is feasible and would provide evidence about the effectiveness of a GDS treatment for patients with chronic LBP and lumbar disc degeneration. Trial registration ClinicalTrials.gov ID: 910193.

Abstract Background Around one-third of workdays lost in Norway are due to musculoskeletal conditions, with persistent (chronic) pain being the most frequent cause of sick leave and work disability. Increasing work participation for people with persistent pain improves their health, quality of life, and well-being and reduces poverty; however, it is not clear how to best help unemployed people who have persistent pain to return to work. The aim of this study is to examine if a matched work placement intervention featuring case manager support and work-focused healthcare improves return to work rates and quality of life for unemployed people in Norway with persistent pain who want to work. Methods We will use a cohort randomised controlled approach to test the effectiveness and cost-effectiveness of a matched work placement intervention featuring case manager support and work-focused healthcare compared to those receiving usual care in the cohort alone. We will recruit people aged 18–64, who have been out of work for at least 1 month, had pain for more than 3 months, and want to work. Initially, all (n = 228) will be recruited to an observational cohort study on the impact of being unemployed with persistent pain. We will then randomly select one in three to be offered the intervention. The primary outcome of sustained return to work will be measured using registry and self-reported data, while secondary outcomes include self-reported levels of health-related quality of life and physical and mental health. Outcomes will be measured at baseline and 3, 6, and 12 months post-randomisation. We will run a process evaluation parallel to the intervention exploring implementation, continuity of the intervention, reasons for participating, declining participation, and mechanisms behind cases of sustained return to work. An economic evaluation of the trial process will also be conducted. Discussion The ReISE intervention is designed to increase work participation for people with persistent pain. The intervention has the potential to improve work ability by collaboratively navigating obstacles to working. If successful, the intervention may be a viable option for helping people in this population. Trial registration ISRCTN Registry 85,437,524 Registered on 30 March 2022.

Abstract Background Pregnant women and men with pregnant partners experience variations in quality of life (QoL) during pregnancy, a period characterized by physical, psychological, and social changes. Pregnancy is associated with reduced QoL, depressive symptoms, and sleep problems. This study aimed to: (1) determine whether Norwegian pregnant women and men with pregnant partners differed in QoL levels in the third trimester of pregnancy; (2) determine whether the relationship between perception of sleep and QoL is moderated by depressive symptoms, when analyzed separately in pregnant women and men with pregnant partners; and (3) determine whether selected possible predictive factors were associated with QoL when stratified by level of depressive symptoms, in pregnant women and men with pregnant partners separately. Methods A cross-sectional study conducted between October 2018 and January 2020 included 228 pregnant women and 197 men with pregnant partners in the third trimester of pregnancy. The age range was 22–50 years. QoL was assessed using the World Health Organization Quality of Life Questionnaire brief version, depressive symptoms using the Edinburgh Postnatal Depression Scale, and perception of sleep by a single item. Data were analyzed in SPSS version 28 using descriptive statistics, the PROCESS macro for moderation analyses, and multivariate linear regression. The level of statistical significance was p

Abstract Background Limited evidence suggests that surgical and non-surgical obesity treatment differentially influence plasma Lipoprotein (a) [Lp(a)] levels. Further, a novel association between plasma arachidonic acid and Lp(a) has recently been shown, suggesting that fatty acids are a possible target to influence Lp(a). Here, the effects of bariatric surgery and lifestyle interventions on plasma levels of Lp(a) were compared, and it was examined whether the effects were mediated by changes in plasma fatty acid (FA) levels. Methods The study includes two independent trials of patients with overweight or obesity. Trial 1: Two-armed intervention study including 82 patients who underwent a 7-week low energy diet (LED), followed by Roux-en-Y gastric bypass and 52-week follow-up (surgery-group), and 77 patients who underwent a 59-week energy restricted diet- and exercise-program (lifestyle-group). Trial 2: A clinical study including 134 patients who underwent a 20-week very-LED/LED (lifestyle-cohort). Results In the surgery-group, Lp(a) levels [median (interquartile range)] tended to increase in the pre-surgical LED-phase [17(7–68)-21(7–81)nmol/L, P = 0.05], but decreased by 48% after surgery [21(7–81)—11(7–56)nmol/L, P

Abstract Background During the transitional phase from childhood to adulthood, adolescents encounter many changes and challenges. Stress is associated with reduced health-related quality of life (HRQOL) in adolescents and, thus, impacts all aspects of their life. Adolescents’ thoughts and beliefs in their capacity may be essential with regard to their subjective perception of stress and coping with it. Insights into the complexity of stress and exploration of the possible underlying mechanisms in adolescence are needed. We sought to describe stress, HRQOL, and self-efficacy and explore the association between stress and HRQOL by testing for self-efficacy as a possible mediator in adolescents. Methods In total, 696 school-based adolescents aged 14–15 years participated in this study. Participants were recruited from 22 schools in the Eastern and Southern parts of Norway. All participants completed an electronic survey in their respective classrooms. The survey included demographic data, the Perceived Stress Questionnaire, the KIDSCREEN-27 questionnaire measuring HRQOL, and the General Perceived Self-Efficacy Scale. Statistical analyses were conducted using the PROCESS macro for SPSS Statistics software by Andrew Hayes model 4. Results Descriptive analyses revealed overall low levels of stress with a score of 0.29 (SD, 0.15). Nevertheless, stress was negatively associated with all HRQOL subscales: physical well-being (B = − 25.60), psychological well-being (B = − 38.43), autonomy and parents (B = − 28.84), social support and peers (B = − 21.05), and school environment (B = − 30.28). Furthermore, these respective associations were all mediated by self-efficacy, which explained approximately one-fifth of the reduction in HRQOL. The highest degree of mediation and, thus, the largest indirect effect was estimated for the HRQOL subscale physical well-being (31.7%). Conclusions Our findings extend prior research on the mechanisms underlying the relationship between perceived stress and HRQOL in adolescents. They demonstrated that perceived stress explained most of the reduction in the HRQOL after adjusting for the effect of self-efficacy. Hence, stress itself appears to be an important target for future interventions to enhance HRQOL, rather than purely focusing on increasing self-efficacy to enhance the HRQOL in adolescents. Our findings highlight the importance of a better understanding of the underlying mechanisms to develop strategic and accurate interventions for adolescents.

BackgroundChronic pain conditions involve numerous physical and psychological challenges, and while psychosocial self-management interventions can be of benefit for people living with chronic pain, such in-person treatment is not always accessible. Digital self-management approaches could improve this disparity, potentially bolstering outreach and providing easy, relatively low-cost access to pain self-management interventions. ObjectiveThis randomized controlled trial aimed to evaluate the short-term efficacy of EPIO (ie, inspired by the Greek goddess for the soothing of pain, Epione), a digital self-management intervention, for people living with chronic pain. MethodsPatients (N=266) were randomly assigned to either the EPIO intervention (n=132) or a care-as-usual control group (n=134). Outcome measures included pain interference (Brief Pain Inventory; primary outcome measure), anxiety and depression (Hospital Anxiety and Depression Scale), self-regulatory fatigue (Self-Regulatory Fatigue 18 scale), health-related quality of life (SF-36 Short Form Health Survey), pain catastrophizing (Pain Catastrophizing Scale), and pain acceptance (Chronic Pain Acceptance Questionnaire). Linear regression models used change scores as the dependent variables. ResultsThe participants were primarily female (210/259, 81.1%), with a median age of 49 (range 22-78) years and a variety of pain conditions. Analyses (n=229) after 3 months revealed no statistically significant changes for the primary outcome of pain interference (P=.84), but significant reductions in the secondary outcomes of depression (mean difference −0.90; P=.03) and self-regulatory fatigue (mean difference −2.76; P=.008) in favor of the intervention group. No other statistically significant changes were observed at 3 months (all P>.05). Participants described EPIO as useful (ie, totally agree or agree; 95/109, 87.2%) and easy to use (101/109, 92.7%), with easily understandable exercises (106/109, 97.2%). ConclusionsEvidence-informed, user-centered digital pain self-management interventions such as EPIO may have the potential to effectively support self-management and improve psychological functioning in the form of reduced symptoms of depression and improved capacity to regulate thoughts, feelings, and behavior for people living with chronic pain. Trial RegistrationClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104

Background: Pain in adolescence is considered a worldwide concern. Adolescents’ pain affects family functioning. However, bidirectional associations should be considered as parental determinates such as pain, stress, and sociodemographic factors are also shown to influence pain in adolescence. Objectives: This study explored the associations between maternal and paternal sociodemographic factors, pain, and stress and adolescents’ pain, and stress on adolescents’ pain. Methods: In total, 508 school-based Norwegian adolescents with a corresponding parent were included. All adolescents completed an electronic survey during school hours, and their respective parents responded electronically. The survey included sociodemographic data, the Perceived Stress Questionnaire, and the Brief Pain Inventory. Results: Herein, 385 adolescents reported an average pain of 2.1 (SD, 1.9), and 308 of the participating parents reported an average pain of 1.6 (SD, 1.8). Regressions stratified by parental gender revealed nonsignificant associations in fathers’ study variables predicting adolescents’ pain. However, having the highest maternal educational level (p ≤ 0.01) and working part-time (p ≤ 0.01) were associated with lower pain in adolescents. Conclusions: The findings of this study demonstrated that sociodemographic factors such as high educational status in mothers and mothers working part-time were associated with lower pain in Norwegian adolescents. These findings highlight the importance of a holistic approach to pain management in adolescence.

Abstract Background Increased knowledge about factors that can impact changes in adolescents’ health-related quality of life (HRQOL) is needed. The present study aimed to investigate possible HRQOL changes in adolescents at 14 and 16 years, and assess the impact of sociodemographic factors, gender, pain, self-esteem, self-efficacy, loneliness, and stress on HRQOL changes over time. Further, to assess HRQOL stratified by gender. Methods A longitudinal study involving 211 adolescents was conducted. Sociodemographic variables, pain, self-esteem, self-efficacy, loneliness, and stress were all assessed with well-validated instruments. KIDSCREEN-27 was used to measure HRQOL. Data were analyzed using independent t-tests, paired samples t-tests, and linear mixed models for repeated measures. Results When all variables were added to the linear mixed models, stress, loneliness, and pain were significantly, independently associated with a reduction in HRQOL change scores for four of the five KIDSCREEN subscales. Time was significantly associated with a reduction in physical and psychological well-being. Self-efficacy and self-esteem were significantly associated with an increase in HRQOL change scores for four and two subscales, respectively. Male gender was significantly negatively associated with changes in social support and peers compared to female gender. Conclusion Our results demonstrated a significant decline in adolescents’ HRQOL regarding physical and psychological well-being for the age range 14–16 years. Furthermore, we found that stress, loneliness, and pain have a significant negative impact on HRQOL changes, whereas self-esteem and self-efficacy have a significant positive impact. Our results highlight the importance of increased understanding regarding factors associated with changes in adolescents’ HRQOL to enable accurate and strategic interventions.

Abstract Background The uncertain and challenging situation caused by the COVID-19 pandemic affects adolescents and their parents in an exceptional way. More knowledge of health-related quality of life (HRQoL), health literacy (HL) and COVID-19-related worries in adolescents and parents 1 year into the pandemic is needed. The present study aimed to describe HRQoL, HL and COVID-19-related worries of 16- to 17-year-old adolescents and parents of adolescents. Further, to assess the strength of associations between gender, HL, COVID-19-related worries and HRQoL. Methods A cross-sectional study involving 215 adolescents and 320 parents was conducted, exploring HRQoL, HL, COVID-19-related worries and sociodemographic variables. KIDSCREEN-10 and RAND-36 were used to measure HRQoL. Data were analyzed using bivariate methods, multiple linear regression and robust regression. Results Adolescents’ HRQoL was notably lower compared to previous Norwegian studies and European norms. Parents’ HRQoL was comparable to Norwegian norms. Adolescents and parents reported moderate-to-high HL and high degrees of COVID-19-related worries. Females reported significantly lower HRQoL and more worries compared to males. In adolescents, higher HL was significantly associated with higher HRQoL. COVID-19-related worries were not significantly associated with HRQoL. In parents, higher HL in the “understand health information” domain was significantly associated with higher HRQoL for mental well-being (mental component sum scores [MCS]) and with lower HRQoL for physical well-being (physical component sum scores [PCS]). Being worried a lot about infecting others and about family/friends becoming sick was significantly associated with higher MCS and lower MCS, respectively. COVID-19-related worries were not significantly associated with PCS. Conclusions Our results indicate that the pandemic has a major negative impact on adolescents’ HRQoL. Parents’ HRQoL remained unchanged and comparable to previous studies. Our study demonstrates that HL, gender and COVID-19-related worries are significantly associated with adolescents’ and parents’ HRQoL, indicating that efforts aimed at increasing their HL might indirectly affect their HRQoL as well and that gender-specific interventions or strategies could be beneficial.

Purpose – Understanding students’ preferences for teaching and course design is important for educators in higher education when planning courses and teaching activities. The purpose of this study was to explore changes in occupational therapy students’ preferences for teaching and courses across the three-year study program. Design/methodology/approach – A total of 263 students participated in a longitudinal study, where preferences were measured with the Approaches and Study Skills Inventory for Students. The data were analyzed with linear mixed effect models for repeated measures. Findings – The results indicated no significant changes in preferences for courses and teaching over the three-year period. Also, there were no significant differences between the six involved study programs. Preferences for the courses and teaching type “supporting understanding” were associated with higher age and higher study effort. Preferences for the courses and teaching type “transmitting information” were associated with lower age and female gender. Originality/value – In summary, the findings of this study suggest that preferences for teaching and courses are stable and may be challenging to alter during a three-year undergraduate study program.

Abstract Background Shoulder pain is a prevalent and often long-lasting musculoskeletal disorder. The overall prognosis of shoulder pain is highly variable with 40–50% of patients reporting persistent pain 6–12 months after consulting a clinician. The evidence for psychological prognostic factors for patients with shoulder pain is inconsistent. Therefore, the objective of this study was to investigate the association between fear of movement and emotional distress at presentation and self-reported disability over one year of follow-up. Methods This is a prospective cohort study of consecutive patients referred to secondary outpatient care due to shoulder pain. Consenting patients underwent a physical examination and completed a comprehensive questionnaire at baseline, three months-, and one-year follow-up. Associations between baseline fear of movement (0–10) or emotional distress (1–4), respectively, and patient reported disability measured using Quick Disability of the Arm and Shoulder (QuickDASH, 0–100) over one year were analyzed with linear mixed-effects models (LMM) for repeated measures (baseline, 3 months and 1 year), adjusting for established prognostic factors. Results A total of 138 patients were recruited between March 2015 and January 2018, with response rates of 84.7% (n = 117) and 79.7% (n = 100) at three months and one year, respectively. Adjusted associations revealed that for every point increase in baseline fear of movement, the QuickDASH score increased (worsened) by 1.10 points (95% CI 0.2–2.0) over the follow-up year. For every point increase in baseline emotional distress, the QuickDASH score increased by 19.9 points (95% CI 13.9–25.9) from baseline over the follow-up year. Conclusion Higher fear of movement and emotional distress scores at baseline were significantly associated with higher disability over one year in patients with shoulder pain referred to secondary care. Our study indicates that these psychological factors affect prognosis and should be considered by clinicians and researchers working with patients with shoulder pain.

Abstract Background Aerobic exercise is an important part of obesity treatment and may improve health-related quality of life (HRQOL). The objective of this study was to compare the effect of two different exercise programs on health-related quality of life in patients with severe obesity. Methods This was a single-center, open-label, randomized, parallel-group study comparing the effects of a 24-week moderate-intensity continuous training (MICT) program and a combined high-intensity interval training program with MICT (HIIT/MICT). The primary objective (specified secondary outcome) was to assess HRQOL by using the general health dimension of the Short Form Health Survey (SF-36). The secondary objectives were to assess other dimensional SF-36 scores, the impact of weight on the physical and psychosocial aspects of quality of life (IWQOL-Lite), and the burden of obesity-specific weight symptoms (WRSM). Results 73 patients were enrolled and reported patient reported outcome measures, with 71 patients (55% females) allocated to either MICT (n = 34) or HIIT/MICT (n = 37). In the intention-to-treat analysis, general health scores increased between baseline and 24-week follow-up in both the HIIT/MICT group and the MICT group, with a mean change of 13 (95% CI 6–21) points and 11 (95% CI 5–17) points, respectively, with no difference between the groups. The effect sizes of these changes were moderate. The vitality and social functioning scores of SF-36, and the physical function and self-esteem scores of IWQOL-Lite increased moderately in both groups, with no difference between groups. The tiredness, back pain, and physical stamina scores based on WRSM showed moderate to strong changes in both the groups. Conclusions Patients who had completed a combined HIIT/MICT program did not experience larger improvements in general health compared with those completing a clean 24-week MICT program. Exercise may confer general health benefits independent of intensity. Trials registration Regional Committees for Medical and Health Research Ethics south east, Norway, October 23, 2013 (identifier: 2013/1849) and ClinicalTrials.gov December 8, 2014 (identifier: NCT02311738).

Abstract Background Intimate partner violence (IPV) during pregnancy is a global health problem with adverse consequences for mothers, infants and families. We hypothesise that information about IPV and safety behaviours during pregnancy has the potential to increase quality of life and the use of safety behaviours and prevent IPV. Methods A multicentre randomised controlled trial among culturally diverse pregnant women in Norway, to test the effect of a tablet-based video intervention about IPV and safety behaviours. Women attending routine antenatal check-ups alone (baseline) were screened for violence (Abuse Assessment Screen) by responding to questions on a tablet, and randomised (1:1) by computer to receive an intervention or a control video. The intervention video presented information about IPV and safety behaviours. The controls viewed a video promoting healthy pregnancy in general. Outcome measures were assessed three months post-partum: The World Health Organization Quality of Life-BREF, the Composite Abuse Scale on violence during the last 12 months and use of safety behaviours based on a 15-item checklist. A general linear model for repeated measures was used to examine the intervention’s effect. The analyses were conducted by intention to treat. Results Among 1818 eligible women, 317 reported IPV and were randomised to an intervention (157) or a control group (160). A total of 251 (79.2%) women completed the follow-up questionnaire: 120 (76.4%) in the intervention group and 131 (81.9%) in the control group. At follow-up, 115 (45.8%) women reported a history of IPV. Few women (n = 39) reported IPV during the last 12 months. No differences in quality-of-life domains and overall quality of life and health were found between the intervention and the control groups. We detected no differences between the use of safety behaviours or IPV frequency and severity during the last 12 months. Conclusion Our intervention did not improve women’s quality of life, use of safety behaviours or exposure to violence. Nevertheless, a tablet-based tool may motivate women experiencing IPV to seek help and support. More research is needed regarding tablet-based interventions for women experiencing IPV, particularly culturally sensitive interventions. Trial registration NCT03397277 registered in clinicaltrials.gov on 11/01/2018.

Abstract Background For many adults, their role as a parent is a vital part of their lives. This role is likely to be associated with a parent’s health-related quality of life (HRQOL). The aim of this study was to explore the associations between gender, demographic and psychosocial variables, pain, and HRQOL in parents of 14–15-year-old adolescents. Methods This was a cross-sectional study that included 561 parents. Data on demographic, psychosocial variables and pain were collected using validated instruments. HRQOL was assessed using the RAND-36. Data were analysed using univariate and hierarchical multiple linear regression analyses. Results Four hundred and thirty-six (78%) mothers and 125 (22%) fathers with a mean age of 45 (SD = 5) years were included. Eighty-one per cent were married/cohabiting, 74% worked full time, and 50% had university education of more than 4 years. Almost one-third reported daily or weekly pain, and more than half (58%) reported using pain analgesics during the previous 4 weeks. Mothers reported significantly lower scores on self-efficacy, self-esteem and for all RAND-36 domains, including the physical component summary (PCS) and mental component summary (MCS) and experienced greater stress than fathers. Hierarchical regression analyses showed that working part-time (beta = 0.40) or full time (beta = 0.52) (reference: not working) had the strongest positive effect on PCS. Absence from work for > 10 days (beta = −0.24) (reference: no absence), short-term pain (beta = −0.14), chronic pain (beta = −0.37) (reference: no pain), and stress (beta = −0.10) had the strongest negative effects on PCS. High self-esteem (beta = 0.11) had the strongest positive effect, whereas stress (beta = −0.58) and absence from work for > 10 days (beta = −0.11) (reference: no absence) had the strongest negative effects on MCS. Conclusion Mothers reported significantly lower scores on self-efficacy, self-esteem, and HRQOL, and experienced greater stress than the fathers. A high proportion of parents reported pain. Pain, stress, and low work affiliation were strongly associated with decreased HRQOL in parents. We recommend that parents of adolescents should be provided guidance about coping with pain and stress, and facilitation of a strong work affiliation because these seem to be important to parents’ HRQOL.

Abstract Background Having good Quality of Life (QoL) is essential, particularly for women after childbirth. However, little is known about the factors associated with maternal QoL after giving birth. We aimed to investigate the relationship between characteristics of the mother (socio-demographic variables), selected symptoms (depression and joy/anger), health perception (perception of birth) and possible characteristics of the environment (infant temperament, colic, sleep, parental relationship), with mothers’ overall quality of life when the child is 6 months of age. Methods This study is based on the Norwegian Mother, Father and Child Cohort Study (MoBa), conducted at the Norwegian Institute of Public Health from June 1999 to December 2008, which included a total of 86,724 children. Maternal QoL was assessed by the Satisfaction With Life Scale. Joy and anger were measured using the Differential Emotional Scale, mothers’ mental health was assessed using the Edinburgh Postnatal Depression Scale and satisfaction with relationship was measured using the Relationship Satisfaction Scale. Child temperament was measured using the Infant Characteristics Questionnaire and colic, sleep duration and feelings related to childbirth were assessed by mothers’ reports. The associations between life satisfaction and selected variables were analysed using stepwise multiple linear regression models, and the results are presented as effect sizes (ES). Results Maternal feelings of joy of having a baby (ES = 0.35), high relationship satisfaction (ES = 0.32), as well as having a baby with normal sleep (ES = 0.31), are factors associated with higher maternal overall QoL. Postnatal depression was negatively associated with mothers’ QoL, and infant colic or child’s temperament (fussiness) showed no such association with mothers’ QoL. Conclusions Health professionals and clinicians should focus on infants sleep but also on supporting joy of motherhood and strengthening relationships of the new parents when they develop health interventions or provide counselling to new mothers and their families.

The main objective of this study was to investigate the association between quality of life (QOL) and civil status, self-efficacy, loneliness, and physical and mental health among public health nurse (PHN) students during the COVID-19 pandemic in April 2020. PHN students were recruited from eight universities and university colleges in Norway. A range of potential predictive factors were entered into a model using a stepwise linear regression approach. In general, the PHN students reported a high level of QOL during the first month of the pandemic. The students' civil status, perceived physical health, self-efficacy and loneliness were all significantly correlated with QOL. Among these, the strongest predictive factors for QOL were found to be perceived loneliness and self-efficacy. Our results provide insight into the QOL of PHN students, which managers in the higher education sector can use to outline specific coping strategies that can help students during a pandemic.

Introduction Patient satisfaction is one of the important indicators of quality care. Objective To examine patient ratings of pain management satisfaction before and after introducing a nurse-led management program. Methods A quasi-experimental design with three cross-sectional surveys between October 1, 2016 and June 15, 2017. A total of 845 patients admitted to the four inpatient departments (medicine, surgery, maternity, and gynecology) of Jimma University Medical Centre were invited to participate in the study. A questionnaire adapted from the American Pain Society Patient Outcome Questionnaire, Pain Treatment Satisfaction Scale, and related literature was used for the survey. Data were analyzed using the chi-square test (categorical variables), t -tests for continuous variables, and robust regression to determine the effect of nurse-led management program on patient satisfaction. For all tests, p -values

Abstract Background To promote health-related quality of life (HRQOL) in adolescents with pain, it is important to study factors associated with pain. This study aimed to describe selected factors and pain in 14–15-year-old adolescents and their parents, to assess how these factors are associated with adolescent pain groups, and to explore whether the relationship between pain intensity and HRQOL in adolescents with persistent pain is mediated by self-esteem and self-efficacy. Methods A cross-sectional study was performed among 508 dyads of adolescents (14–15 years) and parents in a school-based setting. Among these, 148 adolescents had persistent pain. We explored the following variables: HRQOL, pain, self-efficacy, self-esteem, sleep, loneliness, stress and sociodemographic variables. All variables were assessed with well-validated instruments. HRQOL was measured with KIDSCREEN-27. Analyses included Chi-square, ANOVA, Mann–Whitney U tests, Kruskal–Wallis and the PROCESS macro method for mediation analyses. Results Adolescents with pain reported significantly higher levels of stress, loneliness and lack of sleep and lower levels of self-efficacy, self-esteem and HRQOL compared to adolescents without pain. More girls than boys reported pain. Adolescents with persistent pain scored significantly worse on self-esteem, stress, loneliness, lack of sleep, school absence, pain and HRQOL compared to adolescents with shorter pain duration. Adolescent pain groups did not differ significantly considering parental factors. However, more adolescents with persistent pain reported that someone in their family had pain. The associations between pain intensity and the HRQOL subscales in adolescents with persistent pain were completely mediated by self-esteem, but not by self-efficacy. The highest degree of mediation was estimated for the HRQOL subscale school environment (indirect effect = 73.5%). Conclusions Our findings highlight the complexity within adolescent pain, demonstrating that adolescents with pain differ from adolescents without pain when it comes to gender, school absence, factors within-person and between-persons. Longer pain duration makes adolescents more vulnerable. We confirm the importance of resilience factors for HRQOL but indicate that self-esteem is more important than self-efficacy. To promote HRQOL in adolescents with persistent pain, a strengthening of both their self-esteem and self-efficacy is recommended. We highlight the need for an individual, holistic approach to adolescent pain.

Abstract Aim To compare the effects of flipped classroom and traditional auditorium lectures, on nursing students’ examination results in bioscience. Design An educational intervention study. Methods All the first‐year students in the bachelor programme (N = 493) were entered into a database and randomly assigned to the intervention or the control group in a course in bioscience. The outcome measures are the proportion of students who passed the examination, and the distribution of grades from A to E. Chi‐square tests and Mann–Whitney Wilcoxon test were used. The odds to pass versus fail were modelled using binary logistic regression. Results The proportion of students who did not pass the final examination was very similar in the intervention and the control groups, 21.4% and 23.6% (p = .574). Our data did not reveal any statistically significant differences concerning the distribution of grades (p = .691). Students with biology and/or natural science had higher odds for passing.

Abstract Background Sleep and colic problems in infancy have been linked to adverse health outcome, but there is limited knowledge of the association between sleep and colic problems in infancy and subsequent development, emotional and behavior problems in young children. The aim of the present study was to examine whether there is an associations between infants’ crying and sleep problems at 6 months and behavioral and development problems at 18 months, 3 and 5 years. Methods This study is based on the Norwegian Mother, Father and Child Cohort Study (MoBa), conducted at the Norwegian Institute of Public Health from June 1999 to December 2008. A total of 86,724 children were included. Colic and sleep (sleep duration, nocturnal awakenings and easy to put to bed) was assessed by mother-reports. Z-scores were used to assess differences between groups of children (e.g. having colic or not, having a sleep problem or not). Emotional and behavioral problems were measured with items from the Child Behavior Checklist. Development problems were measured with items from The Ages and Stages Questionnaire. Results Infants with colic scored significantly lower on development at 5 years (B=-0.10, CI [− 0.14 to - 0.06]) and higher on internalizing problems both at 3 years (B=0.15. CI [0.11 to 0.18]) and 5 years (B=0.17. CI [0.12 to 0.21]) than the reference population. Children who awoke frequently and were more difficult to put to bed at 6 months scored significantly lower on development at 18 months and 3 and 5 years, and higher on internalizing behavior problems at 3 and 5 years (B=0.18 and B=0.16). Children with shorter sleep duration at 6 months had more internalizing behavior problems at 3 years (B=0.14. CI [0.07 to 0.21]) and 5 years (B=0.15. CI [0.05 to 0.25]) than the reference population. Conclusions Colic and sleep problems early in life should be taken into account as risk factors for development and behavioral problems within the first 5 years of a child’s life.

AbstractBackground and aims Peroral endoscopic myotomy (POEM) is an established therapy for achalasia, but outcome evaluation has often been limited to Eckardt score (ES). The present study was aimed to improve knowledge about outcome evaluation and predictive outcome factors by performing a comprehensive objective evaluation of achalasia patients treated by POEM.Methods This single centre prospective study reports outcome data 12 months after POEM in treatment-naive achalasia patients. A predefined follow-up protocol included ES, high resolution manometry, 24-h pH measurement, upper endoscopy and timed barium esophagogram (TBE). Univariate and multivariate regression analyses were performed to analyze association between post-POEM variables and identify predictive factors for objective outcome.Results Fifty patients were included with a drop-out rate of 3 cm after POEM was associated with treatment failure assessed by ES (p = .04) and TBE (p = .03). Advanced achalasia stage (p = .02) and long symptom duration (p = .04) were identified as independent predictive factors for poor outcome assessed by TBE.Conclusions The present study confirms that POEM is an efficient therapy for achalasia. The comprehensive objective evaluation after POEM demonstrates that long symptom duration and major changes in oesophageal anatomy at diagnosis imply poor treatment outcome, and a post-POEM dilated oesophagus is associated with treatment failure.Key messagesPeroral endoscopic myotomy (POEM) is established as a safe and effective therapy for achalasia.Timed barium esophagogram offers objective variables that are valuable in treatment response evaluation.Advanced achalasia stage and long symptom duration are predictive factors for poor objective treatment response after POEM.

Abstract Background To enhance and better understand health-related quality of life (HRQOL) in adolescents, it is important to study factors associated with HRQOL. The present study aimed to assess possible associations between sociodemographic variables, self-efficacy, self-esteem, pain, sleep, loneliness, stress and HRQOL in 14 to 15-year-old adolescents. Methods A cross-sectional study was performed among 696 adolescents (14–15 years) in a school-based setting. Sociodemographic variables, self-efficacy, self-esteem, pain, sleep, loneliness and stress were analyzed. The variables were all assessed with well-validated instruments. HRQOL was analyzed using KIDSCREEN 27. Analyses included Chi-square, independent t-tests, Mann–Whitney U tests, linear regression analyses and hierarchical regression analyses. The results from linear regression models were expressed as standardized beta. Results The adolescents generally reported high levels of HRQOL. However, girls scored significantly worse on HRQOL, self-efficacy, self-esteem, pain, sleep, loneliness and stress compared to boys. Using hierarchical regression analyses we found that Self-efficacy (beta = 0.11–0.24), Self-esteem: (beta = 0.12–0.21), Loneliness: (beta = − 0.24 to − 0.45) and Stress: (beta = − 0.26 to − 0.34) revealed the strongest associations with the HRQOL dimensions. Sociodemographic-, pain- and sleep related covariates were all significantly associated with some of the KIDSCREEN subscales, however their effect on the outcome was smaller than for the psychosocial variables listed above. Being a girl, not living with both parents, not having both parents working, being absent from school more than 4 days, having pain and having lack of enough sleep were all independently negatively associated with HRQOL. Conclusions HRQOL is strongly associated with self-efficacy, self-esteem, loneliness and stress in 14 to 15-year-old adolescents. Our findings indicate that positive psychosocial factors such as self-efficacy and self-esteem might play a buffer role for negative psychosocial factors (e.g. stress) in adolescents. Further, our results show that girls score significantly worse on factors that are associated to HRQOL compared to boys. To improve HRQOL in school-based populations of adolescents, we suggest that future interventions should aim to strengthen self-efficacy and self-esteem. We recommend gender specific interventions.

Abstract Background A large number of women with breast cancer suffer from fatigue, and social support is described as having a positive impact on health in stressful life situations. The aim of this study is to evaluate social support in a sample of early-stage breast cancer outpatients with fatigue during treatment, and to evaluate the association between cancer-related fatigue and social support and between social support and demographic and treatment characteristics. Method This cross-sectional study includes 160 outpatients with early-stage breast cancer and cancer-related fatigue. The patients were recruited from clinics at a university-based cancer centre in Norway. The research instruments included The Social Provisions Scale (SPS), which measures ‛attachment’, ‛social integration’, ‛reassurance of worth’, and ‛nurturance’, and a fatigue questionnaire (FQ), which measures total, physical and mental fatigue. Data were analysed using descriptive statistics and linear regression analysis. Results Median total score for SPS was 59 (min/max = 39/64). Significant associations were found between mental fatigue and the provisions ‛reassurance of worth’ (B = − 0.34, 95% CI = [− 0.60; − 0.08]) and ‛nurturance’ (B = 0.20, 95% CI = [0.08; 0.31]). In addition, an association was found between social support and living with someone (B = 6.09, 95% CI = [4.07; 8.11]). No associations were found between physical fatigue and social support or between social support and treatment variables. Conclusions To a large extent, breast cancer patients with fatigue in this study experienced social support from their surroundings. The fact that there were significant associations between mental fatigue and two of the provisions of SPS suggests that social support is more closely related to mental fatigue than to physical fatigue. Findings from this study suggest that living with someone is important for the experience of social support during treatment for breast cancer. Clinicians need to evaluate demographic characteristics in relation to social support in early-stage breast cancer patients with fatigue.

Abstract Background Musculoskeletal disorders are the leading cause of sickness absence and disability pension in Norway. There is strong evidence that long-term sickness absence due to musculoskeletal disorders are associated with a reduced probability of return to work (RTW). A way to meet the economic and resource-demanding challenges related to individual follow-up of this group is to identify and treat those individuals with a high risk of prolonged sickness. The overall purposes of this project are 1) to determine the most accurate screening tool to identify people at a high risk of prolonged sickness absence due to an musculoskeletal disorder, and 2) to investigate severity of musculoskeletal health, health-related quality-of-life, health care utilization, and costs across different risk profiles in people on sick leave due to a musculoskeletal disorder. Methods People older than 18 years of age on sick leave for at least 4 weeks due to a musculoskeletal disorder will be invited to participate in this prospective observational cohort study conducted within the Norwegian Welfare and Labor Administration (NAV) system in collaboration with OsloMet – Oslo Metropolitan University. The main outcome is sickness absence, obtained from the NAV registry. Data on sickness absence will be retrieved prospectively in the period from study inclusion to 12 months follow-up, and retrospectively 12 months before inclusion in the study. Possible risk factors will be self-reported by the participants at inclusion while health care utilization will be retrieved from registry data. To conduct analyses including 15 to 20 predictor variables, we aim at including 500–600 people on sick leave due to musculoskeletal disorders. Discussion This study may provide tools that can be used to identify individuals with high risk of prolonged sickness absence and may thus be important from both a socioeconomic and individual perspective. Further, the study may give valuable insight into identification of sickness absence profiles and the associations between these profiles and musculoskeletal health status, health-related quality of life and costs. Trial registration Retrospectively registered in ClinicalTrials.gov (NCT04196634, 27.11.2019).

Abstract Background Impaired sleep is common in menopausal women. The aim was to examine associations between uses of systemic menopausal hormone therapy (MHT) and sleep disturbance in a large population sample. Methods Female participants aged 45 to 75 years were selected from the Norwegian Health Study in Nord-Trøndelag (HUNT3, 2006–2008) (N = 13,060). Data were linked to the Norwegian Prescription Database, identifying use of prescribed MHT and use of sleep medication. Data were analyzed using multiple linear regression. Results In total, 996 women used systemic MHT (7.6%), with the highest prevalence of 10.3% among women 55 to 64 years of age. Despite high reports of frequent nocturnal awakening (24.7%) and high reports of hot flashes, use of MHT was low in this large population based survey. Although MHT use was associated with more sleep disturbance in unadjusted analyses, the association was not significant after adjusting for relevant covariates. Using sleep medication, reporting poor health, tobacco and alcohol use, doing daily exercise, having higher levels of anxiety, and being less satisfied with life were factors showing the strongest associations with sleep disturbance. Conclusion The lack of association between MHT and sleep disturbance suggests that other factors, such as self-perceived good health, a healthy lifestyle and anxiety/depression, are more relevant to sleep than MHT.

Objective: To assess if recording the sensory latencies of the median and ulnar nerves one-by-one (consecutive) or at the same time (simultaneous) in the ring-finger test for carpal tunnel syndrome (CTS) will show equivalent results or if it will lead to a different clinical classification of patients. Methods: We assessed the limits of agreement between the simultaneous and the consecutive method based on the median- ulnar sensory latency difference derived by both methods in 80 subjects and compared the number of minimal CTS cases identified by the two methods. Results: Limits of agreement ranged from −0.23 to 0.29 ms. A significantly higher proportion of subjects with minimal CTS (only detectable by using the comparison test) was found using the simultaneous method (n = 8 and 2, respectively; p = 0.03). Conclusion: The two methods have a poor to moderate agreement as indicated by the range of the limits of agreement (0.5 ms). Significance: Even small methodological changes to the ring-finger test can lead to results with different clinical meaning in the same individual and one should be aware of which method was used when interpreting results.

Objectives To describe characteristics of older adults with back pain in primary care, and to assess associations between patient characteristics and type of first primary care provider (general practitioner (GP), physiotherapist (PT) or chiropractor).Design Cross-sectional analysis from the Back Complaints in the Elders-Norway cohort study.Setting Norwegian GP, PT and chiropractic primary care centres.Participants Patients aged ≥55 years seeking Norwegian primary care with a new episode of back pain were invited to participate. Between April 2015 and February 2020, we included 452 patients: 127 first visited a GP, 130 first visited a PT and 195 first visited a chiropractor.Primary and secondary outcome measures For the first objective, the outcome measure was descriptive statistics of patient characteristics, covering the following domains: sociodemographic, general health, current and previous back pain, psychological and clinical factors. For the second objective, first primary care provider was the outcome measure. Associations between patient characteristics and visiting a GP or PT compared with a chiropractor were assessed with multiple multinomial regression analyses.Results Median (IQR) age was 66 (59–72) years. Levels of back-related disability was moderate to severe, with a median (IQR) Roland-Morris Disability Questionnaire (range 0–24) score of 9 (5–13). Recurring episodes were common, 301 (67%) patients had monthly or yearly recurrences. Patients with worse back-related disability, longer duration of symptoms, lower expectations for full recovery and worse physical performance measured with the Back Performance Scale had higher odds of visiting a GP or PT compared with a chiropractor (p

Introduction The number of gynaecological cancer survivors is increasing and there is a need for a more sustainable model of follow-up care. Today’s follow-up model is time-consuming and patients have reported unmet needs regarding information about their cancer and strategies for managing the consequences of treatment. The main aim of this study is to assess health-related empowerment—in terms of patient education, psychosocial support, and promotion of physical activity—in a new follow-up model by comparing it to standard follow-up in a quasi-randomised study involving intervention hospitals and control hospitals.Methods and analysis At the intervention hospitals, patients will be stratified by risk of recurrence and late effects to either 1 or 3 years’ follow-up. Nurses will replace doctors in half of the follow-up visits and focus in particular on patient education, self-management and physical activity. They will provide patients with information and guide them in goal setting and action planning. These measures will be reinforced by a smartphone application for monitoring symptoms and promoting physical activity. At the control hospitals, patients will be included in the standard follow-up programme. All patients will be asked to complete questionnaires at baseline and after 3, 6, 12, 24 and 36 months. Blood samples will be collected for biobanking at 3, 12 and 36 months. The primary outcome is health-related empowerment. Secondary outcomes include health-related quality of life, adherence to physical activity recommendations, time to recurrence, healthcare costs and changes in biomarkers. Changes in these outcomes will be analysed using generalised linear mixed models for repeated measures. Type of hospital (intervention or control), time (measurement point), and possible confounders will be included as fixed factors.Ethics and dissemination The study is approved by the Regional Committee for Medical Research Ethics (2019/11093). Dissemination of findings will occur at the local, national and international levels.Trial registration number NCT04122235.

Abstract Background In return-to-work (RTW) programs, coordinators are often provided in order to integrate services. However, models of coordinating services vary widely internationally, and across different programs, where one distinction is between vertical and horizontal integration (i.e. between levels/institutions, or within one service/level). The aim of this study was therefore to explore and describe if and how a coordinator was provided in RTW-programs, and whether the provision of a coordinator was associated with certain personal or intervention characteristics. Methods The study was designed as a cohort study following employees participating in a variety of Rapid-RTW-programs in Norway (n = 39). Employees (n = 494) answered a self-administered questionnaire, which was linked to register-data on diagnoses and sickness-absence. Employees who replied yes/no to the question “Did the program provide a person who tailored or coordinated your services?” were included in this analysis. Associations for being provided with a coordinator were tested in adjusted logistic regression models. Results Sixty-nine percent of the employees reported having a coordinator. These coordinators were mainly responsible for coordinating treatment within own programs (i.e. horizontal coordination, 68%). As expected, rehabilitation programs more often provided a coordinator compared to treatment programs (OR 3.87 95% CI 2.42–6.24). The odds for being provided with a coordinator were reduced for each additional year of age of the employee (OR 0.97, 95% CI 0.96–0.99). More professions were involved in programs that provided coordinators, also more contact with other stakeholders like leaders and social insurance services (NAV), but only contact with supervisor remained statistically significant in adjusted analysis (OR 1.69 95% CI 0.31–9.27). The programs with a coordinator more often provided adaptations at the workplace for the individual employee (OR 0.08 95% CI 0.01–0.60). However, these signs of vertical integration were only evident for a limited number of employees. Conclusion In this study, seven of ten employees reported to have a coordinator, which was associated with more professions and stakeholder involvement in the RTW-process. Most of these coordinators did not coordinate vertically between the service levels and types of intervention arenas for sick listed employees (i.e. workplace, social security, and health care services), as recommended in earlier research.

Abstract Background Lateral epicondylitis (LE) is a challenging condition for clinicians, and research has yet not proven the superiority of one specific treatment approach. However, manual therapy (elbow mobilization) in addition to eccentric exercise has been found to be superior to exercise alone. As well, acupuncture is effective in short-term pain relief when compared with sham treatment, but there is little knowledge on the comparative effectiveness of manual therapy and acupuncture treatment of LE in terms of pain relief. The primary objective of this pilot trial was to assess the feasibility (retention and adherence rates) of performing a randomized controlled trial (RCT) to explore the clinical effectiveness of acupuncture and manual therapy treatment of LE. Methods This pilot trial took place in an outpatient interdisciplinary institute of sports medicine and rehabilitation in Oslo, Norway. Thirty-six adults with clinically diagnosed LE were randomly allocated into one of three groups: eccentric exercise alone, eccentric exercise plus acupuncture, or eccentric exercise plus manual therapy for a 12-week treatment period. Primary outcomes were patient retention and adherence rates. Secondary outcomes included patient-reported pain (NRS), level of disability (Quick-DASH), and participant’s satisfaction with treatment and global perceived effect. Results Nine (69%) patients in the acupuncture group completed the 1-year follow-up, compared to eight (67%) in the manual therapy group and five (45%) in exercise alone. Our goal was to demonstrate a retention rate above 80% to avoid serious threats to validity, but the result was lower than expected. The majority of participants (64%) in both treatment groups received only three-treatment sessions; the reasons included non-attendance or recovery from pain. Secondary outcomes support the rationale for conduction of an RCT. There were no adverse advents related to study participation. Conclusions Based on differences in pain relief between groups, patient retention, and adherence rates, an RCT seems to be feasible to assess treatment effectiveness more precisely. In a future definitive trial, greater dropout may be reduced by maintaining contact with the participants in the exercise alone group throughout the intervention, and objective assessments might be considered. Trial registration ClinicalTrials.gov, NCT02321696

Abstract Background To assess the association between cardiorespiratory fitness (CRF) and weight changes in treatment seeking patients with severe obesity who underwent a 1-year intensive lifestyle intervention (ILI) program. Methods Retrospective cohort study conducted at a tertiary care outpatient rehabilitation center from November 1, 2013 through January 1, 2017. CRF was measured as maximal oxygen consumption during a maximal oxygen uptake (VO2max) test on a treadmill or bicycle at baseline and after 3 months. Results A total of 180 patients had a baseline mean (SD) BMI 41.1 (4.8) kg/m2 and CRF of 79.4 (14.9) mL·kg-0.75·min− 1. Patients with a baseline CRF above median achieved a greater 3-month and 1-year weight loss compared with patients with CRF below median; mean (95% CI) 2.5 kg (1.3, 3.8) and 4.0 kg (0.8, 7.2), respectively. In addition, patients with 3-month changes of CRF above median had 4.0 kg (0.9, 7.1) greater weight loss at 1-year follow-up than those below median. Conclusions Among patients with severe obesity who underwent a 1-year ILI program, higher baseline CRF was associated with significantly larger weight loss after 3 months and 1 year. In addition, those with higher initial 3-month CRF changes had greater weight loss at 1 year. Trial registration Retrospectively registered in Regional Committees for Medical and Health Research Ethics (REC) south east September 22, 2016 (2016/1414) and clinicaltials.gov August 13, 2018 (identifier: NCT03593798).

Abstract Background Intimate partner violence (IPV) around the time of pregnancy is a recognized global health problem with damaging consequences. However, little is known about the effect of violence assessment and intervention during pregnancy. We hypothesise that routine enquiry about IPV during pregnancy, in combination with information about IPV and safety behaviours, has the potential to increase the use of these behaviours and prevent and reduce IPV. Methods The Safe Pregnancy study is a randomised controlled trial (RCT) to test the effectiveness of a tablet-based intervention to promote safety behaviours among pregnant women. Midwives include women who attend routine antenatal care. The intervention consists of a screening questionnaire for violence and information about violence and safety behaviours through a short video shown on a tablet. The materials are available in different languages to ensure participation of Norwegian, Urdu, Somali and English-speaking women. Eligible women answer baseline questions on the tablet including the Abuse Assessment Scale (AAS). Women who screen positive on the AAS will be randomized to an intervention video that contains information about violence and safety behaviours and women in the control group to a video with general information about a healthy and a safe pregnancy. All women receive information about referral resources. Follow up will be at three months post-partum, when the woman attends the maternal and child health centre (MCHC) for the baby’s check-up. Outcome measures are: Use of safety behaviours and quality of life (primary outcomes), prevalence of violence, mental health measures and birth outcomes (secondary outcomes). Intention to treat analysis will be performed. Discussion The project will provide evidence on whether enquiry about violence and a short video intervention on a tablet is effective and feasible to prevent or reduce harm from IPV among women who attend antenatal care. Trial registration This study is registered in ClinicalTrials.gov. Identifier: NCT03397277 (Registered 11th January 2018).

Abstract Background Limited research exists concerning the long-term effects of avalanches on survivors’ mental health beyond the first years after the accident. The aims of this study were to describe and evaluate possible differences in long-term mental health symptoms after a major avalanche disaster between exposed and unexposed soldiers using a longitudinal design. Method Present mental health symptoms were examined among avalanche exposed (n = 12) and unexposed (n = 9) soldiers by PTSS-10, IES-15 and STAI-12 in four waves (1986–1987 and 2016). Results Binary logistic regression revealed that the odds to score above the cut-off were significantly lower for both groups after one year compared to baseline for PTSS-10 (p = 0.018) and significantly lower after 30 days compared to baseline for IES-15 (p = 0.005). Data did not reveal significant differences between the exposed and unexposed groups regarding adjusted PTSS-10, IES-15 or STAI-12 mean scores compared. Linear mixed model-analyses revealed significant effects of time. The adjusted mean scores declined over time for both groups: PTSS-10 (p = 0.001), IES-15 (p = 0.026) and STAI-12 (p = 0.001), and the time trajectories for PTSS-10 were significantly different between the groups (p = 0.013). Although not significant (all p > 0.05), results indicated that a larger proportion of soldiers in the exposed group experienced posttraumatic stress symptoms (5/12) (PTSS-10 score ≥ 4) and distress symptoms (6/12) (IES-15 score ≥ 26) above cut-off points, 30 years post-disaster. Conclusions The course of mental health symptoms may persist, and even increase, in selected and trained military personnel 30 years after exposure to a natural disaster. These findings may be of great importance for health authorities planning appropriate follow-up.

We explored the fecal microbiota in pediatric patients Results: The bacterial abundance was statistically significantly reduced in the IBD and non-IBD patients compared to the healthy children for several beneficial species. The CD patients had a lower abundance of Bifidobacterium species compared to the UC patients, and the IBD patients in need of biologic therapy had a lower abundance of butyrate producing bacteria. Based on the abundance of bacterial species at diagnosis, we constructed Diagnostic, Phenotype and Prognostic Indexes. Patients with a high Diagnostic Index had 2.5 times higher odds for having IBD than those with a lower index. The CD patients had a higher Phenotype Index than the UC patients. Patients with a high Prognostic Index had 2.1 higher odds for needing biologic therapy compared to those with a lower index. Conclusions: The fecal abundance of bacterial species can aid in diagnosing IBD, in distinguishing CD from UC and in identifying children with IBD in need of biologic therapy.

Introduction: Patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) present with a range of symptoms including post-exertional malaise (PEM), orthostatic intolerance, and autonomic dysfunction. Dysfunction of the blood vessel endothelium could be an underlying biological mechanism, resulting in inability to fine-tune regulation of blood flow according to the metabolic demands of tissues. The objectives of the present study were to investigate endothelial function in ME/CFS patients compared to healthy individuals, and assess possible changes in endothelial function after intervention with IV cyclophosphamide.Methods: This substudy to the open-label phase II trial “Cyclophosphamide in ME/CFS” included 40 patients with mild-moderate to severe ME/CFS according to Canadian consensus criteria, aged 18–65 years. Endothelial function was measured by Flow-mediated dilation (FMD) and Post-occlusive reactive hyperemia (PORH) at baseline and repeated after 12 months. Endothelial function at baseline was compared with two cohorts of healthy controls (N = 66 and N = 30) from previous studies. Changes in endothelial function after 12 months were assessed and correlated with clinical response to cyclophosphamide. Biological markers for endothelial function were measured in serum at baseline and compared with healthy controls (N = 30).Results: Baseline FMD was significantly reduced in patients (median FMD 5.9%, range 0.5–13.1, n = 35) compared to healthy individuals (median FMD 7.7%, range 0.7–21, n = 66) (p = 0.005), as was PORH with patient score median 1,331 p.u. (range 343–4,334) vs. healthy individuals 1,886 p.u. (range 808–8,158) (p = 0.003). No significant associations were found between clinical response to cyclophosphamide intervention (reported in 55% of patients) and changes in FMD/PORH from baseline to 12 months. Serum levels of metabolites associated with endothelial dysfunction showed no significant differences between ME/CFS patients and healthy controls.Conclusions: Patients with ME/CFS had reduced endothelial function affecting both large and small vessels compared to healthy controls. Changes in endothelial function did not follow clinical responses during follow-up after cyclophosphamide IV intervention.

Background: Salivary cortisol (SC), a commonly used biomarker for stress, may be disrupted by negative events in pregnancy, at birth and in infancy. We aimed to explore if maternal perceived stress (PSS) in or after pregnancy and SC levels in pregnancy were associated with SC in early infancy, and, secondly, to identify early life factors associated with infants’ SC levels (iSC). Methods: At 3 months of age, SC was analyzed in 1057 infants participating in a Nordic prospective mother-child birth cohort study. Maternal PSS was available from questionnaires at 18- and 34-week gestational age (GA) and 3-month post-partum, and SC was analyzed at 18-week GA. Early life factors included sociodemographic and infant feeding from questionnaires, and birth data from medical charts. Associations to iSC were analyzed by Spearman correlation and multinomial logistic regression analyses. Results: In this exploratory study neither PSS at any time point nor maternal SC (mSC) were associated with iSC. Higher birth weight was associated with higher levels of iSC, while inverse associations were observed in infants to a mother not living with a partner and mixed bottle/breastfeeding. Conclusions: Maternal stress was not associated with iSC levels, while birth weight, single motherhood and infant feeding may influence iSC levels.

Background: Both propranolol and candesartan are prophylactic drugs for migraine, but with unknown mechanisms of action. The objectives of the present study were to investigate these drugs’ effects on arterial wall dynamics and the potential relation between their vascular and clinical effect. Methods: The study was based on data from a previously published randomized, placebo-controlled, triple-blinded, double crossover clinical trial comparing the prophylactic effects of candesartan and propranolol in 72 patients. Finapres noninvasive blood pressure curves were analyzed. On the descending limb of the pulse curve, a notch is produced by pulse wave reflection, and its relative height compared to the top of the curve (the notch ratio) was used as a marker of arterial wall stiffness. Results: Candesartan decreased the notch ratio from baseline ( p = 0.005), reflecting more compliant arteries and vasodilation, whereas propranolol increased the notch ratio ( p = 0.005), reflecting less compliant arteries and vasoconstriction. There was no difference in baseline notch ratio between clinical responders and nonresponders. Conclusion: The drugs are both efficient prophylactic medications, yet they have opposite effects on arterial wall dynamics. This suggests that drug effects other than those on arterial compliance must be responsible for their prophylactic effect in migraine.

BACKGROUND & AIMS:The prognostic role of gender in patients with liver cirrhosis is not fully understood. Our primary aim was to assess how gender affects cumulative incidence and risk of death without liver transplantation (LT) in cirrhotic patients with gastroesophageal varices. Secondary aims were to assess the relationship between gender and cause specific death, risk of variceal bleeding and incidence rates of gastroesophageal varices in patients with cirrhosis. METHODS:All new patients with gastroesophageal varices due to liver cirrhosis at Oslo University Hospital between 2006 and May 2016 were identified. Clinical data were retrieved retrospectively from hospital files. Causes of death were classified according to a specified protocol in cases of in-hospital-death, otherwise by data from the Norwegian Death Registry. Competing risk analyses were used to calculate cumulative incidences and risks of i) all-cause death, ii) cause-specific death and iii) variceal bleeding or re-bleeding. RESULTS:Cumulative one- and five years incidence of death without LT in 266 included patients were 28% and 51%, respectively. In univariate analysis, risk of death was positively associated with age, Child Pugh class, alcoholic liver disease and presentation with variceal bleeding, and negatively associated with female sex. In a multivariate model, risk of death without LT was associated with female sex (SHR 0.59 [0.40-0.86]), age (SHR 1.05 [1.04-1.07] per year), Child Pugh class B (SHR 1.54 [1.03-2.32]) and Child Pugh class C (SHR 4.29 [2.57-7.17]). Variceal bleeding caused 27% of deaths. Adjusting for age and Child Pugh score, a trend towards reduced risk of death due to variceal bleeding was seen in women (SHR 0.53; [0.26-1.06]). High alcohol consumption was associated with increased risk of first variceal bleeding, both at univariate analysis (SHR 7.73 [1.71-34.9]) and multivariate analysis (SHR 13.9 [2.51-77.0]). CONCLUSIONS:Reduced mortality due to variceal bleeding may contribute to improved survival without LT in cirrhotic women with gastroesophageal varices.

Lactate treatment has shown a therapeutic potential for several neurological diseases, including Alzheimer’s disease. In order to optimize the administration of lactate for studies in mouse models, we compared blood lactate dynamics after intraperitoneal (IP) and subcutaneous (SC) injections. We used the 5xFAD mouse model for familial Alzheimer’s disease and performed the experiments in both awake and anaesthetized mice. Blood glucose was used as an indication of the hepatic conversion of lactate. In awake mice, both injection routes resulted in high blood lactate levels, mimicking levels reached during high-intensity training. In anaesthetized mice, SC injections resulted in significantly lower lactate levels compared to IP injections. Interestingly, we observed that awake males had significantly higher lactate levels than awake females, while the opposite sex difference was observed during anaesthesia. We did not find any significant difference between transgenic and wild-type mice and therefore believe that our results can be generalized to other mouse models. These results should be considered when planning experiments using lactate treatment in mice.

Background/Aims: Many variables influence the quality of life in older adults with dementia. We aim to quantify how the relationship between pain and quality of life in nursing home residents with severe dementia can be explained by neuropsychiatric symptoms, depressive symptoms, and activities of daily living. Methods: This article presents cross-sectional baseline data from a cluster randomised controlled trial. Results: The total and direct effects of pain on quality of life were statistically significant. Both neuropsychiatric and depressive symptoms partially mediated the relationship between pain and quality of life. Activities of daily living acted as a mediator only when modelled together with depressive symptoms. Conclusion: Pain, neuropsychiatric symptoms, and depressive symptoms appear to be important factors that influence the quality of life for nursing home residents with severe dementia. Therefore, multidimensional interventions may be beneficial for maintaining or improving quality of life in this population.

Background Exercise interventions are frequently recommended for patients with rotator cuff disease, but poor content reporting in clinical trials of exercise limits interpretation and replication of trials and clinicians’ ability to deliver effective exercise protocols. The Consensus on Exercise Reporting Template (CERT) was developed to address this problem.Objective To assess completeness of content reporting of exercise interventions in randomised controlled trials for patients with rotator cuff disease and the inter-rater reliability of the CERT.Design Critical appraisal.Methods Independent pairs of reviewers applied the CERT to all 34 exercise trials from the most recent Cochrane Review evaluating the effect of manual therapy and exercise for patients with rotator cuff disease. We used the CERT Explanation and Elaboration Statement to guide assessment of whether each of the 19-item criteria were clearly described (score 0–19; higher scores indicate better reporting). Percentage agreement and the prevalence and bias adjusted kappa (PABAK) coefficient were used to measure inter-rater reliability.Results The median CERT score was 5 (range 0–16). Percentage agreement was high for 15 items and acceptable for 4 items. The PABAK coefficient indicated excellent (5 items), substantial (11 items) and moderate (3 items) inter-rater agreement.Conclusion The description of exercise interventions for patients with rotator cuff disease in published trials is poorly reported. Overall, the inter-rater reliability of the CERT is high/acceptable. We strongly encourage journals to mandate use of the CERT for papers reporting trial protocols and results investigating exercise interventions.

BACKGROUND:Experiences during a stay in the intensive care unit (ICU), including pain, delirium, physical deterioration, and the critical illness itself, may all influence survivors' health-related quality of life (HRQOL). However, few studies have examined the influence of social support, comorbidity, and pain interference on ICU survivors' HRQOL. OBJECTIVES:To investigate possible associations between social support, number of comorbidities, and pain interference on HRQOL in ICU survivors. METHODS:ICU survivors responded to a survey 3 months (n = 118) and 1 year (n = 89) after ICU discharge. HRQOL was measured using the Short Form Health Survey-12 (v1), social support using the revised Social Provision Scale, pain interference using the Brief Pain Inventory-Short Form, and comorbidities using the Self-Administered Comorbidity Questionnaire. RESULTS:Physical and mental HRQOL were reduced at both 3 months and 1 year in ICU survivors compared with the general population. This reduction was more pronounced at 3 months for physical HRQOL, while a small reduction in mental HRQOL was not clinically relevant. Social support was statistical significantly positively associated with mental HRQOL at 3 months, while number of comorbidities was statistical significantly associated with a reduction in physical HRQOL at 3 months and 1 year and mental HRQOL at 1 year. Lastly pain interference was significantly associated with a reduction in physical HRQOL at 3 months and 1 year. CONCLUSIONS:ICU survivors primarily report reduced physical HRQOL. Social support was positively associated with mental HRQOL, while number of comorbidities, and pain interference were all significantly associated with a reduction in HRQOL. Pain interference was associated with the largest reduction in HRQOL.

There is little knowledge about how factors early in life affect the development of migraine and tension-type headache. We aimed to examine whether growth restriction in utero is associated with development of migraine and frequent tension-type headache in adults.The population-based Nord-Trøndelag Health Study (HUNT 3) contained a validated headache questionnaire, which differentiated between migraine and tension-type headache. These data were linked to information on weight and gestational age at birth from the Norwegian Medical Birth Registry. In total 4557 females and 2789 males, aged 19-41 years, were included in this registry-based study. Participants were categorized as appropriate for gestational age (AGA, 10th-90th percentile), small for gestational age (SGA, 3rd-10th percentile) or very small for gestational age (VSGA, < 3rd percentile). Logistic regression was used to calculate odds ratios (OR) with 95% confidence intervals (CI) for migraine and tension-type headache, with exposure being growth restriction at birth.The effect of growth restriction on migraine was modified by sex, with a significant association in males (p