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Background Pediatric postoperative pain is still undertreated. Aims To assess whether educational intervention increases nurses’ knowledge and improves pediatric postoperative pain management. Design Cluster randomized controlled trial with three measurement points (baseline T1, 1 month after intervention T2, and 6 months after intervention T3). Participants/Subjects The study was conducted in postanesthesia care units at six hospitals in Norway. Nurses working with children in the included units and children who were undergoing surgery were invited to participate in this study. Methods Nurses were cluster randomized by units to an intervention (n = 129) or a control group (n = 129). This allocation was blinded for participants at baseline. Data were collected using “The Pediatric Nurses’ Knowledge and Attitudes Survey Regarding Pain: Norwegian Version” (primary outcome), observations of nurses’ clinical practice, and interviews with children. The intervention included an educational day, clinical supervision, and reminders. Results At baseline 193 nurses completed the survey (75% response rate), 143 responded at T2, and 107 at T3. Observations of nurses’ (n = 138) clinical practice included 588 children, and 38 children were interviewed. The knowledge level increased from T1 to T3 in both groups, but there was no statistically significant difference between the groups. In the intervention group, there was an improvement between T1 and T2 in the total PNKAS-N score (70% vs. 83%), observed increase use of pain assessment tools (17% vs. 39%), and children experienced less moderate-to-severe pain. Conclusions No significant difference was observed between the groups after intervention, but a positive change in knowledge and practice was revealed in both groups. Additional studies are needed to explore the most potent variables to strengthen pediatric postoperative pain management.

Background Weight loss improves fatty liver disease. No randomized trial has compared the effects of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) on liver fat content and fibrosis. Objective To compare the 1-year effects of SG and RYGB on hepatic steatosis and fibrosis. Design Single-center, randomized, controlled trial (Oseberg [ObesitySurgery in Tonsberg]). (ClinicalTrials.gov: NCT01778738). Setting Tertiary care obesity center in Norway. Participants 100 patients (65% female; mean age, 47.5 years; mean body mass index, 42 kg/m2) with type 2 diabetes mellitus (T2DM). Intervention From January 2013 to February 2018, patients were randomly assigned (1:1 ratio) to SG or RYGB. Measurements The primary outcome was remission of T2DM (previously published). Predefined secondary outcomes in the present study were hepatic steatosis and fibrosis assessed by magnetic resonance imaging (liver fat fraction), enhanced liver fibrosis (ELF) test, noninvasive indices, and liver enzymes. Results Liver fat fraction declined similarly after SG (-19.7% [95% CI, -22.5% to -16.9%]) and RYGB (-21.5% [CI, -24.3% to -18.6%]) from surgery to 1-year follow-up, and almost all patients (SG, 94%; RYGB, 100%) had no or low-grade steatosis at 1 year. The ELF score category remained stable in 77% of patients, but 18% experienced worsening of fibrosis at 1 year, with no substantial between-group difference. Limitations Single-center study, short follow-up time, and lack of power for secondary outcomes. Conclusion With an almost complete clearance of liver fat 1 year after surgery, RYGB and SG were both highly effective in reducing hepatic steatosis. Bariatric surgery had less influence on degree of fibrosis in the short term, but assessment of long-term progression is warranted. Primary funding source Vestfold Hospital Trust and the South-Eastern Norway Regional Health Authority.

Background: Norwegian hospitals have operated within capacity during the COVID-19 pandemic. We present patient and management characteristics, and outcomes for the entire cohort of adult (>18 years) COVID-19 patients admitted to Norwegian intensive care units (ICU) from 10 March to 19 June 2020. Methods: Data were collected from The Norwegian intensive care and pandemic registry (NIPaR). Demographics, co-morbidities, management characteristics and outcomes are described. ICU length of stay (LOS) was analysed with linear regression, and associations between risk factors and mortality were quantified using Cox regression. Results: In total, 217 patients were included. The male to female ratio was 3:1 and the median age was 63 years. A majority (70%) had one or more co-morbidities, most frequently cardiovascular disease (39%), chronic lung disease (22%), diabetes mellitus (20%), and obesity (17%). Most patients were admitted for acute hypoxaemic respiratory failure (AHRF) (91%) and invasive mechanical ventilation (MV) was used in 86%, prone ventilation in 38% and 25% of patients received a tracheostomy. Vasoactive drugs were used in 79% and renal replacement therapy in 15%. Median ICU LOS and time of MV was 14.0 and 12.0 days. At end of follow-up 45 patients (21%) were dead. Age, co-morbidities and severity of illness at admission were predictive of death. Severity of AHRF and male gender were associated with LOS. Conclusions: In this national cohort of COVID-19 patients, mortality was low and attributable to known risk factors. Importantly, prolonged length-of-stay must be taken into account when planning for resource allocation for any next surge. This study was funded by The Norwegian Research Council and Oslo University Hospital.

Cisplatin-based chemotherapy (CBCT) can cause high-frequency hearing loss, but little is known about the development and clinical relevance of this hearing loss in survivors of adult-onset cancer with very long-term follow-up. This case-control study investigates hearing and speech perception both in quiet and with background noise 30-years after CBCT.One-hundred-and-one patients (Cases) who received CBCT for testicular cancer between 1980 and 1994 were assessed with pure-tone audiometry (.125 - 8 kHz) and speech perception tests including hearing in noise test (HINT). Self-reported hearing and tinnitus was scored by participants. Results were compared with 30 age-matched controls.The median age of Cases and Controls was 60 (46 - 83) and 61 years (51 - 74), respectively. The median observation time for Cases was 30 years (22 - 37). Compared with Controls, Cases had 8 and 19 dB worse age-adjusted high-frequency hearing at 6 and 8 kHz, respectively (Cisplatin causes high-frequency hearing loss, but speech perception tests performed both in quiet and in background noise 30 years post-treatment indicate that the clinical relevance is limited for most patients. Few patients develop severe hearing loss that requires rehabilitation but it is important to identify these patients. Self-reported hearing loss and tinnitus were more common among Cases compared with Controls.

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: A population-based longitudinal study, using data from the Norwegian Mother and Child Cohort Study 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-; - 0.06]) and higher on internalizing problems both at 18 months (B=-0.06 .CI [-0.09-; - 0.03]) and 3 years (B=-0.05 .CI [0.08-; - 0.01]) than the reference population. Children who awoke frequently (≥ 3 times) 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 18 months and 3 years (B=0.18 and B=0.16), and children with shorter sleep duration (≤ 10 hours) at 6 months had more internalizing behavior problems at 18 months (B=-0.14. CI [0.07; - 0.02]) and 3 years (B=-0.15 .CI [0.05-; - 0.25]) than the reference population.Conclusions: Colic and disruptive sleep early in life are risk factors for development, emotional and behavioral problems within the first five years of a child’s life. It is important to be aware that disruptive sleep and colic in infancy may have long-term negative consequences.

Background and Aims The long-term course of ulcerative colitis [UC] is difficult to predict. Mortality, colectomy, cancer, and hospitalisation represent hard outcomes of disease. Moreover, knowledge on the risk of relapses and need for potent medication add important information about living with UC. We aimed to evaluate the course and prognosis of UC during the first 20 years after diagnosis, and to identify early prognostic risk factors. Methods From 1990 to 1994, a population-based inception cohort of patients with inflammatory bowel disease was enrolled in South-Eastern Norway. A systematic follow-up [FU] was conducted at 1,5, 10, and 20 years after diagnosis. Clinical outcomes were recorded continuously, and possible relationships between early disease characteristics and outcomes were analysed using multiple regression analysis. Results Among 519 UC patients, 119 died, 60 were lost to FU, and 340 were included in the FU cohort. The 20-year cumulative risk of colectomy was 13.0% (95% confidence interval [CI] [11.4-14.6]). Extensive colitis at diagnosis was independently associated with an increased risk of colectomy compared with proctitis (hazard ratio [HR] = 2].8, 95% CI [1.3–6.1]). In contrast, mucosal healing at 1-year FU was independently associated with reduced risk of colectomy [HR = 0.4, 95% CI [0.2–0.8]), and inversely associated with subsequent risk of relapse [adjusted HR = 0.5, 95% CI [0.3–0.7]). Conclusions The overall risk of colectomy in our cohort was lower than expected from previous studies, although considerable for patients with extensive colitis at diagnosis. Early mucosal healing was associated with better disease outcomes 20 years after diagnosis.

Background In‐person cognitive‐behavioral stress‐management interventions are consistently associated with reduced cancer distress. However, face‐to‐face delivery is an access barrier for many patients, and there is a need to develop remote‐delivered interventions. The current study evaluated the preliminary efficacy of an application (app)‐based cancer stress‐management intervention, StressProffen, in a randomized controlled trial. Methods Cancer survivors, maximum 1‐year posttreatment (N = 172), were randomized to StressProffen (n = 84) or a usual care control group (n = 88). Participants received a blended delivery care model: (a) one face‐to‐face introduction session, (b) 10 app‐based cognitive‐behavioral stress‐management modules, and (c) follow‐up phone calls at weeks 2‐3 and 6‐7. Outcome measures included stress (Perceived Stress Scale), anxiety and depression (Hospital Anxiety Depression Scale), and health‐related quality of life (HRQoL; Short‐Form Health Surveys [SF‐36]) at 3‐months post‐intervention, analyzed with change scores as dependent variables in linear regression models. Results Participants were primarily women (82%), aged 20‐78 years (mean 52, SD 11.2), with mixed cancer types (majority breast cancer; 48%). Analysis of 149 participants completing questionnaires at baseline and 3 months revealed significant intervention effects: decreased stress (mean difference [MD] −2.8; 95% confidence interval [CI], [−5.2 to −0.4]; P = .022) and improved HRQoL (Role Physical MD = 17.7, [CI 3.7‐31.3], P = .013; Social Functioning MD = 8.5, [CI 0.7‐16.2], P = .034; Role Emotional MD = 19.5, [CI 3.7‐35.2], P = .016; Mental Health MD = 6.7, [CI 1.7‐11.6], P = .009). No significant changes were observed for anxiety or depression. Conclusions Digital‐based cancer stress‐management interventions, such as StressProffen, have the potential to provide easily accessible, effective psychosocial support for cancer survivors., In a randomized controlled trial, cancer survivors with access to an app‐based cognitive‐behavioral stress‐management intervention (StressProffen) compared with a control group reported a significant reduction in perceived stress level and a significant increase in health‐related quality of life at 3 months. Interventions such as StressProffen, with easy access and use, have the potential to provide low cost, highly accessible psychosocial support for a large group of cancer survivors.

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.

Purpose: Testicular cancer survivors (TCSs) have increased risk of reduced kidney function related to treatment burden, but longitudinal studies of renal outcome in aging TCSs have been lacking. This longitudinal study describes age- and treatment-related kidney function changes in TCSs compared to a comparison group from the general population. Patients and methods: Estimated glomerular filtration rate (eGFR) was determined in blood samples from Norwegian TCSs (diagnosed 1980–1994) and surveyed median 11, 19 and 26 years since diagnosis (Survey1 [N = 1273], 2 [N = 849] and 3 [N = 670]) defining four treatment groups; Surgery only, Radiotherapy (RT) only, Cisplatin-based chemotherapy (CBCT) ≤850 mg and High CBCT/RT >850 mg cisplatin or any combination of CBCT with RT. A comparison group was constructed from similarly aged men who participated in a population-based health survey. By multiple linear regressions and generalized mixed models for repeated measurements, we studied difference in eGFR between TCSs and the comparison group for all TCSs combined and stratified by treatment modality. Results: At Survey 1, the kidney function for the youngest TCSs combined versus the comparison group was significantly reduced by mean six units (mL/min/1.73 m2) with further decline to mean 12 units at Survey 3. The kidney function was significantly reduced in all treatment groups with the largest differences emerging for TCSs from the High CBCT/RT Group, thus indicating a deteriorating impact of high cumulative doses of cisplatin. Conclusion: Collated to the comparison group, the kidney function in TCSs became increasingly impaired during nearly three post-treatment decades, related to the treatment modality. Early detection and intervention of kidney dysfunction is important to reduce the risk of TCSs' long-term morbidity and mortality related to nephrotoxicity, such as cardio-vascular diseases.

Highlights • The median and ulnar nerves can be recorded consecutively or simultaneously to diagnose carpal tunnel syndrome. • Simultaneous and consecutive recording of the median and ulnar nerves sensory latency have a poor agreement. • Technical variations can have diagnostic consequences., 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.

Background The Institute for Medical Technology Assessment Productivity Cost Questionnaire (iPCQ) was recently developed to cover all domains of productivity costs; absenteeism, presenteeism and productivity costs related to unpaid work. The original iPCQ has not been tested with respect to neither content or construct validity, nor reliability, and there is no Norwegian version of the questionnaire. Objectives To translate and cross-culturally adapt the iPCQ into Norwegian and to test its measurement properties among patients with musculoskeletal disorders. Methods Translation and cross-cultural adaptation was conducted according to guidelines, and measurement properties were investigated using a cross-sectional design including a test–retest assessment. Patients with musculoskeletal disorders were recruited from secondary care. Data quality, content validity (10 patients evaluated comprehensibility, 2 researchers and 1 clinician evaluated relevance and comprehensiveness), construct validity (factor analysis, internal consistency, divergent hypothesis testing), and test–retest reliability (intraclass correlation coefficient two-way random average agreement, Cohen’s unweighted kappa) were assessed. Results In total, 115 patients with a mean age (SD) of 46 (9) years were included, and 62 responded to the retest. The questionnaire was feasible, with little missing data and no floor or ceiling effects. Content validity displayed good comprehensibility and relevance and sufficient comprehensiveness. Factor analysis revealed a 3-component solution accounting for 82% of the total variance; items loaded as expected and supported the original structure of the iPCQ. Internal consistency was acceptable for the 3 components of productivity cost, with an inter-item correlation ranging from 0.42 to 0.62. Further, a total of 91% of our hypotheses were verified. The intraclass correlation coefficient values ranged from 0.88 to 0.99 for all items except one; kappa ranged from 0.61 to 0.92, indicating overall good reliability of the questionnaire. Conclusions The Norwegian iPCQ showed good measurement properties among patients with musculoskeletal disorders from secondary care in Norway. We therefore recommend the iPCQ as a useful tool for measuring productivity costs in patients with musculoskeletal disorders.

Background Family caregivers of patients in the intensive care unit (ICU) experience impairments in the quality of life. Previous studies report that psychological quality of life improves over time, but there has been limited longitudinal research, and measurement points have differed. Factors such as age, gender, and posttraumatic stress symptoms have been found to be associated with the quality of life, but level of hope and its associations with the quality of life have not been investigated. Objectives The objective of this study was (1) to evaluate changes in the quality of life in family caregivers during the first year after a patient's admission to the ICU and (2) to identify associations between patients' and family caregivers' background characteristics, posttraumatic stress symptoms, hope, and quality of life. Methods A longitudinal study design with five measurement points was used. Family caregivers completed study questionnaires at enrolment into the study and at 1, 3, 6, and 12 months after the patient's admission to the ICU. The quality of life was measured with the 12-Item Short Form Health Survey. Results Family caregivers (N = 211) reported improved psychological quality of life during the first year after the patient's admission to the ICU, but it was still lower than the psychological quality of life reported in norm-based data. Being on sick leave, consulting healthcare professionals (e.g., general practitioner), and increased level of posttraumatic stress symptoms were significantly associated with psychological quality of life, whereas hope was not. Reported physical quality of life was comparable to norm-based data. Conclusion Family caregivers of patients in the ICU reported impairments in quality of life during the first year after the patient's admission to the ICU. Being on sick leave, consulting healthcare professionals, and reduced posttraumatic stress symptoms may improve mental quality of life.

Background: The impact of social media, with its speed, reach and accessibility, in interventions aimed to improve adherence to guidelines such as assessment of Pain, Agitation/Sedation and Delirium (PAD) in intensive care is not described. Therefore, the primary objective of this quality improvement study was to evaluate the impact of a multifaceted intervention including audit and feedback of quality indicators (QI) via Facebook-groups, educational events and engagement of opinion leaders on adherence to PAD-guidelines in four ICUs. Methods: A quasi-experimental interrupted time series study with eight monthly data points in the two phases Before and Intervention was designed. Proportion of nursing shifts with documented PAD-assessment (PAD-QIs) were retrieved from the electronical medical chart from included adult ICU patient-stays in four participating ICUs. Difference between the two time periods was assessed using generalised mixed model for repeated measures with unstructured covariance matrix, and presented as Beta (B) with 95% confidence interval (CI). Results: Finally, 1049 ICU patient-stays were analysed; 534 in Before and 515 in Intervention. All three PAD-QIs significantly increased in Intervention by 31% (B = 30.7, 95%CI [25.7 to 35.8]), 26% (B = 25.8, 95%CI [19.4 to 32.2]) and 34% (B = 33.9, 95%CI [28.4 to 39.4]) in pain, agitation/sedation and delirium, respectively. Conclusion: A multifaceted intervention including use of Facebook-groups was associated with improved guideline-adherence in four ICUs, as measured with process PAD-QIs of PAD assessment. Further research on use of social media to improve guideline adherence is warranted, particularly as social distancing impacts clinical education and training and new approaches are needed. publishedVersion

Background Pain is a serious problem for intensive care unit (ICU) patients, but we are lacking data on pain at the hospital ward after ICU discharge. Aims and objectives To describe pain intensity, -interference with function and -location in patients up to 1 year after ICU discharge. To identify demographic and clinical variables and their association with worst pain intensity and pain interference. Design A longitudinal descriptive secondary analysis of a randomized controlled trial on nurse-led follow-up consultations on post-traumatic stress and sense of coherence after ICU discharge. Methods Pain intensity, -interference, and -location were measured using Brief Pain Inventory at the hospital ward and 3, 6, and 12 months after ICU discharge. For associations, data were analysed using multivariate linear mixed models for repeated measures. Results Of 523 included patients, 68% reported worst pain intensity score above 0 (no pain) at the ward. Estimated means for worst pain intensity and -interference (from 0 to 10) after ICU discharge were 5.5 [CI 4.6-6.5] and 4.5 [CI 3.7-5.3], and decreased to 3.8 [CI 2.8-4.8] (P ≤ .001) and 2.9 [CI 2.1-3.7] after 12 months (P ≤ .001). Most common pain locations were abdomen (43%), lower lumbar back (28%), and shoulder/forearm (22%). At 12 months, post-traumatic stress (PTS) symptoms ≥25 (scale 10-70), female gender, shorter ICU stay, and more traumatic ICU memories were significantly associated with higher worst pain intensity. PTS symptoms ≥25, female gender, more traumatic ICU memories, younger age, and not having an internal medical diagnosis were significantly associated with higher pain interference. Conclusions Early after ICU discharge pain was present in 68% of patients. Thereafter, pain intensity and -interference declined, but pain intensity was still at a moderate level at 12 months. Health professionals should be aware of patients' pain and identify potentially vulnerable patients. Implication for practice Longitudinal assessment of factors associated with pain early after ICU discharge and the following year is a first step that could improve follow-up focus and contribute to reduced development of chronic pain.

BACKGROUND Post-traumatic stress (PTS) symptoms following intensive care unit (ICU) treatment can lead to post-traumatic stress disorder and represent a severe health burden. In trauma patients, a strong sense of coherence (SOC) is associated with fewer PTS symptoms. However, this association has not been investigated in a general ICU sample. AIMS AND OBJECTIVES To examine the occurrence of PTS symptoms in general ICU patients early after ICU discharge and to assess possible associations between PTS symptoms and SOC, ICU memory, pain, and demographic and clinical characteristics. DESIGN This was a cross-sectional study. METHODS Adult patients aged ≥18 years admitted for ≥24 hours to five ICUs between 2014 and 2016 were recruited. PTS symptoms and SOC were measured at the ward within the first week after discharge from the ICU using the Posttraumatic Stress Scale-10 and Sense of Coherence Scale-13. Multiple linear regression analysis was used to identify associations between PTS symptoms and SOC and the selected independent variables. RESULTS A total of 523 patients were included (17.8% trauma patients; median age 57 years [range 18-94]; 53.3% male). The prevalence of clinically significant PTS symptoms was 32%. After adjustments for gender and age, lower SOC (P

Background: Roux-en-Y gastric bypass is associated with increased risk of bone fractures. Malabsorptive procedures may be associated with secondary hyperparathyroidism and detrimental effects on bone health. We aimed to compare the effects of standard and distal gastric bypass on bone turnover markers 2 years after surgery. Methods: Patients with body mass index (BMI) 50–60kg/m2 (n=113) were randomized to standard or distal gastric bypass,105 patients (95%) completed 2-year follow-up. Serum C-terminal telopeptide of type I collagen (CTX-1), procollagen type I Npropeptide (PINP), and bone-derived alkaline phosphatase (BALP) was measured at baseline and up to 2 years after surgery. ANCOVA and linear mixed models were used to compare groups. Results: The levels of bone turnover markers increased significantly in both groups, with no statistically significant difference betweengroups.Two years after standard and distal gastric bypass mean (SD) CTX-1 were 0.81 (0.32) and 0.83 (0.31) μg/L (p= 0.38), mean PINP was 77.6 (23.2) and 77.7 (29.3) μg/L (p=0.42), and BALP 47.9 (21.9) vs. 50.7 (19.6) μg/L (p=0.38), respectively. Multiple linear regression analyses showed that PINP and BALP correlated positively (p=0.01 and p

Study Design.Retrospective administrative database study.Objective.To assess temporal and regional trends, and length of hospital stay, in lumbar spinal stenosis (LSS) surgery in Norwegian public hospitals from 1999 to 2013.Summary of Background Data.Studies from several countries have reported incr

Objectives To describe the prevalence and trajectory of family caregivers’ post-traumatic stress symptoms during the first year after a patient’s admission to the intensive care unit and identify associations between family caregivers’ background characteristics, hope and post-traumatic stress symptoms. Research methodology/designs Family caregivers of intensive care unit patients (n = 211) completed questionnaires at patient admission to the intensive care unit and thereafter at 1, 3, 6, and 12 months. Mixed-model analyses were performed. Setting Four intensive care units in a university hospital in Norway. Main outcome measures Impact of Event Scale—Revised and Herth Hope Index. Results On admission, 54% of family caregivers reported high post-traumatic stress symptom levels, which decreased during the first six months after patient discharge. Lower levels of hope, being younger, having more comorbidities and being on sick leave were associated with higher post-traumatic stress symptom levels. Being the parent of the patient was associated with decreased post-traumatic stress symptom levels. Conclusions Family caregivers of intensive care unit patients report high levels of post-traumatic stress symptoms. Higher levels of hope were associated with fewer post-traumatic stress symptoms.

Aims and objectives:To gather insight in conditions important to an understanding of undocumented migrants’ life situations and more specifically to explore undocumented migrants’ quality of life and how we can understand the various domains of quality of life related to demographics, living conditions, migration history and inflicted burden. Background:Undocumented migrants suffer from economic hardship and acculturative stress, limited psychological and social support and at the same time restricted access to health care and social welfare. Design: An exploratory mixed methods design using primarily quantitative data with a qualitative component was implemented. Methods: Sociodemographic data on 90 undocumented migrants were collected, and self‐report questionnaires on quality of life and psychological distress were completed, supplemented by qualitative data obtained through interviews and additional qualitative questions. The STROBE checklist for cross‐sectional studies was used for reporting this study. Results: Quality of life in our group of undocumented migrants was poor. Leaving their home country because of war or persecution, hunger, having experienced abuse, homelessness and higher age were statistically significantly associated with poorer quality of life. Having membership in a local association and having a partner were statistically significantly associated with better quality of life. Qualitative data indicate that marginal living conditions, fear of death and suffering and conditions associated with dependency were the main components comprising the burden to our respondents, reflecting their precarious juridical status as undocumented migrants. Conclusion: Our respondents’ poor quality of life was related to the complex interplay between possible exposures to traumatic experiences before and during flight and post‐migration traumatisation in relation to our respondents’ experiences of economic, social and acculturative hardship in Norway. Relevance to Clinical Practice: Responses called for to improve undocumented migrants’ quality of life and eliminate barriers to their health care appeal more to nurses as a professional group and to those in positions of authority than each individual nurse on duty. Eckbo’s Legacy (Major og advokat Eivind Eckbos Legat). Grant Numbers: 15350 (2011), 59362 (2013)

Purpose Colorectal cancer (CRC) patients experience several physical and psychological co-occurring symptoms, but little is known about symptom variation during chemotherapy cycles. Therefore, the aims were (1) to assess the occurrence and severity of frequently occurring symptoms (worrying, lack of energy, numbness/tingling, nausea, and pain) at multiple time points during chemotherapy, (2) to investigate differences in symptom trajectories between chemotherapy groups, and (3) to determine whether selected patient and clinical characteristics are associated with symptom severity throughout the treatment trajectory. Methods In total, 120 CRC patients receiving chemotherapy with curative or palliative intent completed the Memorial Symptom Assessment Scale (MSAS), Self-Administered Comorbidity Questionnaire (SCQ-19), and Karnofsky Performance Status (KPS) scale eight times, during two cycles of chemotherapy and 3 and 6 months after enrolment. Data were analyzed using linear mixed models for repeated measures to assess the effects of selected variables on outcomes over time. Results The patients experienced greatest symptom severity in the days following the administration of chemotherapy; these were lack of energy, numbness/tingling (oxaliplatin group), and nausea. Palliative patients reported significantly higher pain scores compared with curative patients over time, whereas the severity of worrying decreased over time in both treatment groups. Age, sex, educational level, performance status, treatment intent and type of chemotherapy were significantly associated with symptom severity throughout the chemotherapy trajectory. Conclusion Clinicians can use these findings to identify and inform patients about risk for more severe symptom burden, in order to offer supportive care at the right time during the chemotherapy treatment.

The efficacy of vedolizumab (VDZ) has been demonstrated in clinical trials. The aim of this report is to evaluate the long-term effectiveness and safety of VDZ in a real-world cohort and to explore possible associations between concentration measurements of VDZ and treatment effectiveness.This is a prospective clinical follow-up including all adult patients with ulcerative colitis (UC) and Crohn's disease (CD) treated with VDZ from October 2014 until September 2017 at a single center in Norway. The patients were followed for at least 14 weeks or until termination of treatment. Clinical and biochemical activity were obtained at every infusion throughout follow-up. Plasma measurements of VDZ (p-VDZ) were performed before every infusion during maintenance therapy.In total, 71 patients received VDZ. Improvement of CRP and hemoglobin was observed in CD but not in UC, whereas Partial Mayo Score improved in UC while no change in Harvey Bradshaw Index was revealed in CD. Furthermore, CRP at baseline was negatively correlated with p-VDZ at week 14 in CD but not in UC patients.Improvement of biochemical markers of inflammation was observed in CD while clinical activity scores improved in UC patients. For CD, baseline CRP was correlated with lower concentrations of p-VDZ at week 14.

ObjectivesAdjuvant treatment of high-risk endometrial cancer (EC) is still controversial. Several studies have tried to clarify the best treatment strategy, and guidelines have been made, but no study to date has shown a survival benefit for radiation over chemotherapy. We aimed to evaluate the outcome of high-risk EC patients treated with adjuvant chemotherapy only in a population where the routine administration of adjuvant radiotherapy was omitted.MethodsThis is a retrospective study including 230 EC patients with International Federation of Gynecology and Obstetrics stage I type II, stage Ib type I/G3, stage II, and IIIc treated at Oslo University Hospital between 2005 and 2012. Standard treatment was hysterectomy, bilateral salpingo-oophorectomy and at least pelvic lymphadenectomy followed by adjuvant chemotherapy.ResultsOf the 230 high-risk patients, standard treatment was given to 146 patients (63.5%): 60 patients in stage I, 10 patients in stage II, and 76 patients in stage IIIc. Only 10% of patients with stage I disease relapsed, with 3.3% locoregional relapses and 6.7% distant relapses. Recurrence rate in stage IIIc was 39.5%, with 7.9% isolated vaginal and 31.6% distant relapses. The 3-year disease-free survival was 92% for stage I, 80% for stage II, and 60% for stage IIIc disease. In the total population, 55 patients had International Federation of Gynecology and Obstetrics stage Ia, 43 Ib, 42 stage II, and 90 stage IIIc disease. Recurrence rate in the total population was 29.6%, with 9.6% isolated vaginal recurrences, 1.7% recurrences located in the pelvis, and 18.3% distant recurrences.ConclusionsPatients with high-risk EC have acceptable vaginal/pelvic control rates after adjuvant chemotherapy. However, prognosis remains poor for patients with stage IIIc disease, also after chemotherapy.

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: 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 six 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.Results: Maternal feelings of joy of having a baby (B=0.35, CI [0.79 to 0.83]), high relationship satisfaction (B= 0.02, CI [0.28 to 0.60]), as well as having a baby with normal sleep (B=0.32, CI [0.21 to 0.22]), 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 these issues when they develop health interventions or provide counselling to new mothers and their families.

Objective This study aimed to compare the effects of two aerobic exercise programs of different intensities on energy expenditure. Methods This was a single‐center randomized controlled trial of patients with severe obesity allocated to a 24‐week moderate‐intensity continuous training (MICT) program or a combined MICT with high‐intensity interval training (HIIT/MICT) program. The primary outcome was energy expenditure during exercise (EEDE). Secondary outcomes included resting metabolic rate, cardiorespiratory fitness, and body composition. Results A total of 82 (56% females) patients were screened, and 71 (55% females) patients were allocated to HIIT/MICT (n = 37) or MICT (n = 34). Per‐protocol analysis showed that EEDE increased by 10% (95% CI: 3%‐17%) in the HIIT/MICT group (n = 16) and 7.5% (95% CI: 4%‐10%) in the MICT group (n = 24), with no differences between groups. In the 8‐ to 16‐ week per‐protocol analysis, the HIIT/MICT group had a significantly larger increase in EEDE compared with the MICT group. Resting metabolic rate remained unchanged in both groups. HIIT/MICT and MICT were associated with significant weight loss of 5 kg and 2 kg, respectively. Conclusions Patients completing a 24‐week combined HIIT/MICT program did not achieve a higher EEDE compared with those who completed a 24‐week MICT program. The HIIT/MICT group experienced, on average, a 3‐kg‐larger weight loss than the MICT group. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

IntroductionThe 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 analysisAt 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 disseminationThe 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 numberNCT04122235.

Purpose Thyroid hypofunction is a late effect observed in several groups of cancer survivors, but has to date not been evaluated in-depth in testicular cancer survivors (TCSs). We investigated the prevalence of thyroid hypofunction in long-term TCSs and compared the findings with those of a comparison group from the general population. Patients and Methods Norwegian TCSs diagnosed with unilateral testicular cancer in the period 1980–1994 (N = 1,436) were grouped according to their cancer treatment (Surgery only; Radiotherapy only; Cisplatin-based chemotherapy, eventually combined with radiotherapy). They were invited to participate in three surveys covering up to three decades post-diagnosis. Serum thyrotropin (s-TSH) from samples collected from the last survey were analyzed. S-TSH results were also available from a health survey of the general population performed in a county in mid-Norway (the HUNT3 Survey [comparison group]). Data on the prescription of thyroid hormone replacement therapy (levothyroxine) from the Norwegian Prescription Database were obtained for the TCSs and the comparison group’s participants. Thyroid hypofunction was defined as ‘untreated’ (overt or subclinical) hypothyroidism (with s-TSH ≥3.5 mIU/L and no regular prescription of levothyroxine) or ‘treated’ hypothyroidism with regular prescription of levothyroxine. Results Three decades after diagnosis the prevalence of thyroid hypofunction (i.e., both treated and untreated) was 11% in the TCSs and the prevalence ratio was 1.9 indicating an almost doubled prevalence in the TCSs compared to the comparison group (prevalence ratio 1.91, 95% CI [1.54; 2.38]). However, there were no significant differences in the risk of thyroid hypofunction related to the TCSs’ treatment modality. Conclusion TCSs may have an increased prevalence of thyroid hypofunction compared to the general population. Hypothyroidism has negative consequences related both to primary hypogonadism and to cardiovascular disease. As both conditions are overrepresented in TCSs, regular monitoring of thyroid hormones may be advisable.

Aims and objectives To evaluate the effectiveness of a psycho-educational intervention for shoulder and breast day surgery patients in decreasing pain intensity and pain interference with function and strengthening adherence with the analgesic regimen; and further to identify factors that influence average pain intensity and pain interference with function. Background Pain is one of the most prevalent symptoms after day surgery. However, pain management is left to the patients and family, and interventions to help patients are needed. Design Randomised clinical trial with an intervention (n = 101) and a usual care group (n = 119) using multiple measurements during 6 months postoperatively. The CONSORT checklist is used. Methods Patients in the intervention group received a booklet about pain and pain management and coaching by research nurses on postoperative days 2, 3 and 7. Differences between groups were identified using the chi-squared analysis and t tests. Changes with time were identified using a linear mixed model with repeated measures. Results After controlling for covariates, group differences at any time in average pain intensity and pain interference with function were not statistically significant. Changes over time within any one group in average pain intensity and pain interference with function were statistically significant and decreased with time. Higher levels of average pain intensity and pain interference over time were associated with shoulder surgery, female, younger, pain expectation, preoperative pain and poorer adherence. Conclusions No group differences related to the intervention were revealed, and preoperative teaching together with a pain management booklet and coaching may help to strengthen the intervention's effects. Further research on interventions directed towards pain management is needed. Relevance to clinical practice Day surgery patients' postoperative pain and pain management is not satisfactorily handled. To encourage and educate patients to use the prescribed analgesics in the immediate postoperative days may be necessary to enhance pain management. Clinical trial registration ClinicalTrials.gov (NCT01595035).

ObjectivesTo 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).DesignCross-sectional analysis from the Back Complaints in the Elders-Norway cohort study.SettingNorwegian GP, PT and chiropractic primary care centres.ParticipantsPatients 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 measuresFor 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.ResultsMedian (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 (pConclusionOlder back pain patients in primary care had moderate to severe levels of back-related disability, and most had recurring episodes. Our results suggest that older adult’s choice of first primary care provider was associated with important patient characteristics, which highlights the need for caution with generalisations of study results across primary care populations.Trial registration numberNCT04261309.

Objectives: Unintended pregnancy in the context of intimate partner violence (IPV) is a public health issue. It is associated with increased health risks for women and their children. Our objective was to investigate the as- sociation between unintended pregnancy and emotional, physical and sexual IPV in a multi-cultural population attending routine antenatal care. Study design: A prospective cross-sectional study of 1788 pregnant women who filled out a questionnaire during pregnancy as part of a randomized controlled trial conducted in southeastern Norway. Main outcome measures: Pregnancy intendedness was measured by asking women if their pregnancy was planned or not. The Abuse Assessment Screen and the Composite Abuse Scale R-SF, consisting of descriptive questions, were used to measure IPV. Chi-square tests, a Mann–Whitney U test, and binary logistic regression analysis were used. Results: Almost one in five women (17.4%) reported that their current pregnancy was unintended. Women with unintended pregnancy were significantly younger, had lower educational backgrounds, more limited economic resources and were more likely to be non-native Norwegian speakers. A total of 15.3% of the women reported some experience of IPV in their lifetime. These women were significantly more likely to experience an unin- tended pregnancy than women who had not experienced IPV, after adjusting for confounding factors: AOR = 1.74 (95% CI [1.23–2.47]). Conclusions: Women who had experienced IPV were significantly more likely to have an unintended pregnancy than women who had not experienced IPV. It is of major importance to identify those women and offer appropriate services during pregnancy. This work was supported by the Research Council of Norway [grant number 260355]. Lena Henriksen was funded by Extrastiftelsen [grant number 016/F076041].

Background 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.

Aims and objectives: To estimate the prevalence and perinatal risk factors associated with parent reported colic, abdominal pain and pain or other discomforts in infants until 3 months of age. Background: Infant colic is a common concern for parents and clinicians. The prevalence varies in different studies and its symptoms overlap with other conditions like abdominal pain and discomfort. Diagnosis criteria are challenging, pathogenesis unclear and risk factors are conflicting. Design: This was a prospective cohort study. Methods: The 1852 mother–child pairs from the PreventADALL prospective birth-cohort answering the 3 months questionnaire were included. Information on perinatal risk factors was collected from the inclusion visit and questionnaires during pregnancy at 18 and 34 weeks, as well as birth charts. STROBE checklist was followed. Results: The reported prevalence of colic was 3% (59/1852), abdominal pain 22% (415/1852) and pain or other discomfort 6% (119/1852), with a total of 26% (478/1852) infants. Mothers on sick leave in pregnancy and reporting any allergic diseases had a significantly higher odds of reporting infant colic, abdominal pain and pain or other discomforts. Mothers with higher perceived stress in pregnancy exhibited a trend towards higher odds for reporting infant pain. Mothers coming from Sweden were less likely to report infant abdominal pain compared to mothers from Norway. Conclusions: The prevalence of abdominal pain and pain or other discomforts was higher than the prevalence of colic. Perinatal risk factors connected to maternal health were associated with all three symptoms. Relevance to clinical practice: Colic and abdominal pain are stressful, symptoms overlap and risk factors for both can be identified in pregnancy. Our study suggests that it is difficult for parents to distinguish among infant colic, abdominal pain and other pain or discomfort and some report two or all three symptoms. Identifying the perinatal risk factors associated with infant pain may help target and support parents. The study was funded by the following funding bodies: The Regional Health Board South East, The Norwegian Research Council, Oslo University Hospital, The University of Oslo, Health and Rehabilitation Norway, Østfold Hospital Trust, by unrestricted grants from the Norwegian Association of Asthma and Allergy, The Kloster Foundation, Norwegian Society of Dermatology and Venerology, Arne Ingel's legat, Fürst Medical Laboratory, The Foundation for Healthcare and Allergy Research in Sweden-Vårdalstiftelsen, Swedish Asthma- and Allergy Association's Research Foundation, Swedish Research Council-the Initiative for Clinical Therapy Research, The Swedish Heart-Lung Foundation, SFO-V Karolinska Institutet, Hesselman Research Foundation, Thermo-Fisher, Uppsala, Sweden.

Methods This multicenter cohort study included 11,081 patients operated with lumbar microdiscectomy, registered at the Norwegian Registry for Spine Surgery. Follow-up was 1 year. Uni- and multivariate logistic regression analyses were used to assess potential prognostic factors for previously defined cut-offs for failure and worsening on the Oswestry Disability Index scores 12 months after surgery. Since the cut-offs for failure and worsening are different for patients with low, moderate, and high baseline ODI scores, the multivariate analyses were run separately for these subgroups. Data were split into a training (70%) and a validation set (30%). The model was developed in the training set and tested in the validation set. A prediction (%) of an outcome was calculated for each patient in a risk matrix. Results The prognostic model produced six risk matrices based on three baseline ODI ranges (low, medium, and high) and two outcomes (failure and worsening), each containing 7 to 11 prognostic factors. Model discrimination and calibration were acceptable. The estimated preoperative probabilities ranged from 3 to 94% for failure and from 1 to 72% for worsening in our validation cohort. Conclusion We developed a prognostic model for failure and worsening 12 months after surgery for lumbar disc herniation. The model showed acceptable calibration and discrimination, and could be useful in assisting physicians and patients in clinical decision-making process prior to surgery. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

The objective was to investigate risk factors and risk profiles associated with neck pain in young adults using longitudinal data from the North-Trøndelag Health Study (HUNT). Risk factors were collected from adolescents (13–19 years of age), and neck pain was measured 11 years later. The sample was divided into two: Sample I included all participants (n = 1433), and Sample II (n = 832) included only participants who reported no neck/shoulder pain in adolescence. In multiple regression analyses in Sample I, female sex (OR = 1.9, 95% CI [1.3–2.9]), low physical activity level (OR = 1.6, 95% CI [1.0–2.5]), loneliness (OR = 2.0, 95% CI [1.2–3.5]), headache/migraine (OR = 1.7, 95% CI [1.2–2.6]), back pain (OR = 1.5, 95% CI [1.0–2.4]) and neck/shoulder pain (OR = 2.0, 95% [CI 1.3–3.0]) were associated with neck pain at the 11-year follow-up. Those with a risk profile including all these risk factors had the highest probability of neck pain of 67% in girls and 50% in boys. In Sample II, multiple regression analyses revealed that female sex (OR = 2.2, 95% CI [1.3–3.7]) and perceived low family income (OR = 2.4, 95% CI [1.1–5.1]) were associated with neck pain at the 11-year follow-up. Girls and boys with a perceived low family income had a 29% and 17% higher probability of neck pain than adolescents with a perceived high family income. The risk profiles in both samples showed that co-occurrence of risk factors, such as headache/migraine, neck/shoulder pain, back pain, low physical activity level, loneliness, and perceived low family income cumulatively increased the probability of neck pain in young adulthood. These results underline the importance of taking a broad perspective when studying, treating, and preventing neck pain in adolescents. Oslo Metropolitan University funded this paper to HJ through a PhD position.

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.

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.

Background Chronic pain can be complex and taxing to live with, and treatment and support require a multicomponent approach, which may not always be offered or available. Smartphones, tablets, and personal computers are already incorporated into patients’ daily lives, and therefore, they can be used to communicate, educate, and support self-management. Although some web-based self-management interventions exist, research examining the evidence and effect of digital solutions supporting self-management for patients living with chronic pain is limited, findings are inconclusive, and new innovative ideas and solutions are needed. Objective This feasibility pilot study aimed to explore the system use, perceived usefulness, ease of use, and preliminary effects of EPIO, an app-based cognitive-behavioral pain self-management intervention program for patients living with chronic pain. Methods The EPIO intervention was delivered in a blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior–based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call at 2 to 3 weeks after the introduction session. Patients living with chronic pain (N=50) completed pre-post outcome measures at baseline and 3 months after the introduction session, with registration of system use (ie, log data) until 6 months. The use, perceived usefulness, and ease of use of the EPIO program were examined through system use data, as well as a study-specific use/usability questionnaire and the System Usability Scale (SUS). Outcome measures to test feasibility of use and estimate preliminary effects included the Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire. Results Participants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80%). Thirty-one participants completed at least six of the nine modules within the 3-month study period (62% completion rate). Forty-five participants completed outcome measures at 3 months, and the EPIO program was rated as useful (ie, “totally agree” or “agree”; 39/45, 87%) and easy to use (42/45, 93%), and as having easily understandable exercises (44/45, 98%). The average overall system usability (SUS) score was 85.7, indicating grade A and excellent system usability. Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049). Conclusions Digital self-management intervention programs may be of use and support for patients living with chronic pain. In this feasibility study, EPIO showed an acceptable program completion rate and was rated as useful and easy to use, with excellent user satisfaction. Program optimization and efficacy testing in a large-scale randomized controlled trial are warranted and in progress. Trial Registration ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104

Aim To assess occurrence of pain during the first 6 days of intensive care unit (ICU) stay and evaluate associations between occurrence of pain and selected patient‐related variables. Design A longitudinal study. Methods Adult ICU patients from three units were included. Patients' pain was assessed with valid pain assessment tools every 8 hr during their first 6 days in ICU. Possible associations between occurrence of pain and selected patient‐related variables were modelled using multiple logistic regression. Results When pain was assessed regularly with pain assessment tools, 10% of patients were in pain at rest and 27% were in pain during turning. The proportions of patients who were in pain were significantly higher for patients able to self‐report pain, compared with patients not able to self‐report (p

STUDY DESIGN A prospective study of patients originally randomized to total disc replacement (TDR) or multidisciplinary rehabilitation. OBJECTIVE To assess the long-term development of facet arthropathy (FA) after TDR versus nonoperative treatment, and to analyze the association between FA and clinical outcome. SUMMARY OF BACKGROUND DATA FA may appear or increase following TDR, but the natural course of FA is unclear, and no previous study has evaluated the long-term development of FA following TDR compared with nonoperative treatment. METHODS The study included 126 patients with chronic low back pain and degenerative changes in the lumbar intervertebral discs. The patients underwent pretreatment and 8-year follow-up magnetic resonance imaging (MRI) and 8-year follow-up computed tomography (CT) of the lumbar spine. The primary outcome measure was FA development (yes/no) on MRI at index level L4/L5 or L5/S1, defined as increased FA grade value from pretreatment to follow-up according to Weishaupt grading system. Secondary outcomes included the association between FA (on MRI and CT) and Oswestry Disability Index (ODI) or back pain as well as reoperations. RESULTS Increased index level FA grade was more frequent after TDR versus nonoperative treatment (36%, 25/69 vs. 2%, 1/57 of patients, P

Objective To evaluate criterion validity of the iMTA Productivity Cost Questionnaire (iPCQ) by comparing iPCQ-reported occurrence and duration of long-term absenteeism (> 4 weeks) with public registry data collected from the Norwegian Labour and Welfare Administration (NAV) among people on sick leave due to musculoskeletal disorders. Method Baseline data from a cohort study was used, in which people on sick leave for at least 4 weeks due to musculoskeletal disorders were recruited electronically through the NAV website. To compare the occurrence of long-term absenteeism overall agreement between the two methods was measured by percentages. To compare the duration (number of days with absenteeism) and adjusted duration (number of days with complete absenteeism) of long-term absenteeism we conducted intraclass correlation coefficient (ICC) two-way random average agreement, descriptive statistic and Wilcoxon signed-rank test. Results In total, 144 participants with a median age (range) of 49 (24–67) were included. The overall agreement on the occurrence of long-term absenteeism was 100%. The ICC value was 0.97 and 0.86 for duration and adjusted duration of long-term absenteeism, respectively. The median difference(iPCQ-registry) between the two methods was 0 and 17 days for long-term absenteeism duration and adjusted duration, respectively. A significant difference between the two methods was observed (Wilcoxon signed-rank test, p Conclusion The iPCQ showed good agreement with public registry data regarding the occurrence and duration of long-term absenteeism among people with musculoskeletal disorders on long-term sick-leave in Norway. However, the iPCQ does not cover part-time sick-leave and thereby potentially overestimate the total amount of long-term absenteeism. Trial registration ClinicalTrials.gov Identifier no. NCT04196634.

This longitudinal study of patients with chronic obstructive pulmonary disease (COPD) aimed to investigate changes in pain characteristics (i.e., occurrence, intensity, and interference) and covariates associated with pain from study enrollment to 12 months, and to investigate if the different pain characteristics were associated with 5-year mortality. In total, 267 patients with COPD completed questionnaires five times over 1 year. The mean age of the patients was 63 years (standard deviation: 9.0), 53% were women, and 46% had very severe COPD. Median number of comorbidities was 2.0 (range: 0–11) and 47% of patients reported back/neck pain. Mixed models and Cox regression models were used for analyses. In total, 60% of the patients reported pain at baseline, and 61% at 12 months. The mixed model analyses revealed that those with better forced expiratory volume in 1 s (% predicted), more comorbidities, only primary school education, and more respiratory symptoms reported significantly higher average pain intensity. Moreover, those with more comorbidities, more respiratory symptoms, and more depression reported higher pain interference with function. At the 5-year follow-up, 64 patients (24%) were deceased, and the cumulative 5-year mortality rate was 22% (95% confidence interval [19–25]). Older age, lower forced expiratory volume in 1 s (% predicted), and higher pain interference at enrollment were all independently and significantly associated with higher 5-year mortality. Our findings show that many patients with COPD have persistent pain, and awareness regarding comorbidities and how pain interferes with their lives is needed.

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).

Aim: To investigate the effect of a communication tool about diet used in public health nurse consultations with parents compared with standard consultations concerning the 2-year-old child's diet. Design: A cluster randomized controlled trial. Methods: Ten municipalities were selected randomly and matched in pairs. In each pair, the control or intervention group was randomly allocated. Parents were recruited to participate from January 2015 to January 2017. In intervention clusters, a communication tool about diet was used to help the parents (N = 140) to focus on a healthy diet for their child. In the control clusters, parents (N = 110) attended standard consultations. The participants completed semi-quantitative food frequency questionnaires at baseline and end point. Results: No effect of the intervention was seen on the child's daily intake of vegetables or saturated fat, or body mass index. Significantly fewer parents desired more information about food for toddlers in the intervention than in the control group. The study was financed by OsloMet – Oslo Metropolitan University.

Introduction: Serological antibodies have been associated with complicated disease course in Crohn’s disease (CD), including the need for surgery. Aim: The aim of this study was to investigate if a panel of relevant antibodies could predict surgery in a prospective population-based cohort of patients with CD. Methods: The population-based IBSEN cohort has been followed prospectively for 20years. At the 10and 20-year follow-up, the following panel of serological antibodies was analysed: pANCA, ASCA IgA, ASCA IgG, anti-OmpC, anti-I2, and anti-CBir1. At the 20-year follow-up or until lost to follow-up, all CDrelated surgeries were registered. Results: Serum was available from 159 patients at 10-year follow-up and 135 patients at 20-year follow-up. In 113 patients, serum was available at both time points. No significant change of antibody status (positive vs. negative) was found from 10-year to 20-year follow-up. Negative pANCA, positive ASCA IgA and positive ASCA IgG at 10-year follow-up were all individually associated with increased risk for CD-related surgery. There was no association between anti-OmpC, anti-I2 or anti-CBir1 and CDrelated surgery. In a multiple regression model including disease location and behaviour, only stricturing or penetrating disease behaviour and negative pANCA remained significantly associated with higher odds for surgery. Conclusion: Positive ASCA IgA and IgG, and negative pANCA were associated with higher odds for CD-related surgery in univariate analysis. Since disease phenotype changes during the disease course, while serological antibodies are stable, our results support the use of pANCA, ASCA IgA and ASCA IgG as prognostic markers in CD. VAK has received a postdoctoral grant from the South Eastern Health Region of Norway.

Background: The aim of the study was to investigate changes in self-rated health (SRH) between different age groups and sexes over a 20-year period. Methods: Data were retrieved from the large longitudinal Health Survey of North Trøndelag, Norway, which includes data collected from more than 190,000 participants aged 20–70+ years between the years 1984 and 2008. Data were analysed using logistic regression and adjusted for sex. Results: From 1984 to 2008, the odds of scoring higher on SRH decreased by 46% in the youngest age group (20–29 years) and increased by approximately 35% in the middle-aged and older age groups (40–70+ years). When considering sex differences, women in most age groups scored lower than the men on their SRH. Conclusions: Our finding suggest a trending shift in SRH, with a reduction in the youngest age group (20–29 years) and an increase in the middle-aged and older age groups (40–70+ years). Despite the sex differences being small, our data indicate that in most age groups, women tend to score lower than men on their SRH. Future studies should focus on these trends to understand better the mechanisms underlying these changes in SRH and to follow future trends to see if the trend is reinforced or diminished.

Objectives Cisplatin-related hearing loss (HL) is claimed to progress after treatment. This controlled longitudinal study with extended follow-up investigates HL in testicular cancer survivors (TCSs) after cisplatin-based chemotherapy (CBCT). Study design Controlled longitudinal study. Methods Eighty-two TCSs treated with CBCT between 1980 and 1994 in Norway participated in two surveys (S1/S3), including pure-tone audiograms (0.125-8 kHz) and self-reported HL, 12 and 31 years after treatment, respectively. Hearing thresholds were age-adjusted based on age-matched hearing thresholds from the general population (controls). Hearing loss was defined as thresholds >20 dB at any frequency. Results Between the two surveys, the prevalence of high-frequency HL (4, 6, and 8 kHz) increased from 73% to 94% but approached those of the aging general population after age adjustment. In TCSs aged >40 years at first survey, HL at the subsequent survey equaled that of controls. Self-reported HL increased from seven (9%) at S1 to 20 (26%) at S3. At S1, age-adjusted HL was identified in all (seven) TCSs reporting decreased hearing whereas at S3, hearing thresholds did not differ from controls in seven out of 20 patients reporting HL. Conclusion CBCT-related ototoxicity causes high-frequency HL, but in contrast to reports from follow-up studies from the first post-treatment decade, no major progression was found beyond the first post-treatment decade for frequencies 0.125-8 kHz. Importantly, with extended follow-up, hearing thresholds of patients approach those of the general population, possibly due to a less-than-additive effect with age-related hearing loss (ARHL) in CBCT-treated patients. Age-and sex-matching is strongly advised in long-term follow-up of CBCT-related ototoxicity. Specificity for detecting ototoxicity with self-reported questionnaires decreases with extended follow-up. Level of evidence 3 Laryngoscope, 130:E515-E523, 2020.

Background Major depressive disorder (MDD) is associated with deficits in executive functioning (EF) that may have a detrimental effect on everyday functioning. Despite this, there are no established cognitive remediation interventions available targeting EF in MDD. Hence, the primary aim of the present pre-registered randomized controlled trial was to evaluate the effectiveness of Goal Management Training (GMT), a metacognitive and strategy-based cognitive remediation intervention to improve EF in MDD. Methods Sixty-three participants with current or previous mild or moderate MDD and self-reported executive deficits were included and randomized to nine sessions of either GMT (two hours, once weekly; n = 35) or computerized cognitive training (one hour, twice weekly; n = 28). Assessments were conducted at baseline (T1), immediately following training (T2), and at six-month follow-up (T3). The primary outcome measure was The Behavior Rating Inventory of Executive Function – Adult version, pertained to daily life EF. Secondary outcome measures included additional EF assessments (performance-based measures and questionnaires), and depressive symptom severity. Results Forty-three participants completed treatment. Both groups improved following training, and linear mixed model analyses revealed no statistically significant differences between the groups for any outcome measure. Additional exploratory within-group analyses revealed a statistically significant reduction of everyday executive dysfunction and reduced depressive symptoms at the six-month follow-up in GMT only. Limitations The study was single-blind, and the sample size was modest. Conclusions Our findings indicate comparable improvements in everyday and performance-based measures of EF, in addition to reductions in depressive symptoms following both GMT and CCT.