Post-traumatic stress symptoms six months after ICU admission with COVID-19: Prospective observational study.

AIMS AND OBJECTIVES: The aim of this study was to investigate the prevalence of post-traumatic stress symptoms, and to identify possible predictive factors in Norwegian intensive care unit survivors, 6 months after admission to the intensive care unit with COVID-19. BACKGROUND: The SARS CoV-2 virus causing COVID-19 has spread worldwide since it was declared a pandemic in March 2020. The most severely ill patients have been treated in the intensive care due to acute respiratory failure and also acute respiratory distress syndrome. It is well documented that these severe conditions can lead to complex and long-lasting symptoms, such as psychological distress, and was, therefore, investigated for the specific COVID-19 population. DESIGN: Prospective observational study. METHODS: Clinical data and patient reported outcome measures were collected by the Norwegian Intensive Care and Pandemic Registry and by the study group 6 months after admission to an intensive care unit. RESULTS: Among 222 COVID-19 patients admitted to Norwegian intensive care units between 10 March and 6 July 2020, 175 survived. The study sample consisted of 131 patients who responded to at least one patient reported outcome measure at 6 months following admission. The primary outcome was self-reported post-traumatic stress symptoms, using the Impact of Event Scale-6 (n = 89). Of those, 22.5% reported post-traumatic stress symptoms 6 months after admission. Female gender, younger age and having a high respiratory rate at admission were statistically significant predictive factors for reporting post-traumatic stress symptoms. CONCLUSIONS: The result is in accordance with previously published research with comparable populations, suggesting that for many COVID-19 survivors psychological distress is a part of the post-acute sequelae. Results from the present study should be replicated in larger datasets. RELEVANCE TO CLINICAL PRACTICE: This project provides important insight to post-acute sequelae after COVID-19 that patients may experience after critical illness.

Prevalence of and predictive factors associated with high levels of post-traumatic stress symptoms 3 months after intensive care unit admission: A prospective study.

BACKGROUND: Post-traumatic stress symptoms (PTSS) following intensive care unit (ICU) treatment may increase morbidity and mortality. Therefore, it is important to identify patients at risk of suffering from such symptoms. OBJECTIVES: The objective of this study was to describe the prevalence and identify possible predictive factors associated with high levels of PTSS 3 months after ICU admission. METHODS: A multicentre, observational study was carried out in six ICUs in Norway. Patients aged ≥18 years were included. The Impact of Event Scale-Revised measured PTSS 3 months after ICU admission. The impacts of pre-ICU measures; demographic and clinical measures; and daily measures of pain, agitation, and delirium were analysed using univariate and multivariate logistic regression models. RESULTS: In total, of the 273 patients included, the prevalence rate of high levels of PTSS was 19.8% (n = 54) 3 months after ICU admission (95% confidence interval [CI]: [15.2, 25.0]). Female gender, age, pre-ICU unemployment, a minimum of one episode of agitation or delirium, and pre-ICU level of functioning in daily living were all significantly associated with high levels of PTSS in univariate logistic analyses. In the multivariate logistic regression, two models were analysed. In model 1, episodes of agitation during ICU stay (odds ratio [OR] = 4.73; 95% CI: [1.17, 19.0]), pre-ICU unemployment (OR = 3.33; 95% CI: [1.26, 8.81]), and pre-ICU level of functioning in daily living (OR = 0.78; 95% CI: [0.63, 0.96]) (implying lower level) increased the odds of reporting high levels of PTSS. In model 2, pre-ICU unemployment (OR = 2.70; 95% CI: [1.05, 6.93]) and pre-ICU level of functioning in daily living (OR = 0.77; 95% CI: [0.62, 0.95]) (implying lower level) increased the odds of reporting high levels of PTSS. CONCLUSIONS: Healthcare personnel are suggested to be aware of ICU patients' pre-ICU employment status, pre-ICU functioning in daily living, and agitation during ICU stay to identify those at risk of PTSS after discharge.

Time trends in human papillomavirus prevalence and genotype distribution in vulvar carcinoma in Norway.

INTRODUCTION: Approximately 25%-43% of all vulvar carcinomas are associated with human papillomavirus (HPV). In many countries, vulvar carcinoma incidence rates are increasing, possibly due to greater HPV exposure. However, studies exploring changes in HPV prevalence and genotype distribution in vulvar carcinoma over time are scarce. Our aim was to evaluate time trends in HPV prevalence and genotype distribution in vulvar squamous cell carcinoma in an unselected, nationwide sample of Norwegian women. Further, we explored clinical and histopathological aspects in relation to HPV status and investigated whether HPV status was associated with survival. MATERIAL AND METHODS: All vulvar squamous cell carcinoma cases from 1970-1975 and 2000-2005 were extracted from the Cancer Registry of Norway and corresponding tissue blocks were retrieved. After detailed histology review, HPV testing was conducted using real-time TaqMan PCR. Overall survival rates were calculated using the Kaplan-Meier method. Multivariable Cox regression analysis was performed to estimate hazard ratios adjusted for age at diagnosis, stage and diagnostic period. RESULTS: Histological review was performed on 352 vulvar squamous cell carcinoma cases. We were able to obtain valid HPV analysis results for 282 cases, Overall, 29.8% (95% CI 24.5%-35.5%) of cases were high-risk HPV (hrHPV)-positive. When comparing the two periods, we found that the percentage of hrHPV-positive tumors increased significantly from 23% (95% CI 16.0%-31.4%) in 1970-1975 to 35.3% (95% CI 27.8%-43.3%) in 2000-2005 (P = 0.025). The predominant genotypes were HPV 16 (73%), HPV 33 (21%), and HPV 18 (6%), with similar distributions in both periods. In the more recent cohort, several additional genotypes were detected: HPV 6, 11, 39, 45, 52, 58 and 66 were found in smaller percentages, ranging from 1.8% to 3.6%. In univariate analysis, patients with HPV-positive tumors showed improved overall survival compared with patients with HPV-negative tumors (hazard ratio [HR] 0.65, 95% CI 0.48-0.86). CONCLUSIONS: The prevalence of HPV in vulvar squamous cell carcinomas in Norway was significantly higher in 2000-2005 than in 1970-1975. The three predominant genotypes were HPV 16, 33 and 18 in both time periods. However, several other HPV genotypes have emerged over the last decades. HPV-positivity was associated with better overall survival.

The impact of New Families home visiting program on first-time mothers' quality of life and its association with social support: a non-randomized controlled study.

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.

Pain in Adolescence: Maternal and Paternal Factors Affecting Adolescents' Pain in Norway-A Cross-Sectional Study.

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.

Resection rates and intention-to-treat outcomes in borderline and locally advanced pancreatic cancer: real-world data from a population-based, prospective cohort study (NORPACT-2).

BACKGROUND: Systemic chemotherapy is the initial treatment strategy for borderline resectable and locally advanced pancreatic cancer to facilitate curative resection. The aim of this study was to investigate the resection rates and overall survival in patients with borderline resectable pancreatic cancer and locally advanced pancreatic cancer. METHODS: Consecutive patients with borderline resectable pancreatic cancer/locally advanced pancreatic cancer discussed by Oslo University Hospital multidisciplinary team between 2018 and 2020, serving a population of 3.1 million within a geographically defined area in south-eastern Norway, were included in this prospective Norwegian Pancreatic Cancer Trial-2 study, according to intention-to-treat principles. The total number of patients with pancreatic cancer was sought from the Cancer Registry of Norway. RESULTS: A total of 1178 patients were diagnosed with pancreatic cancer, of whom 618 were referred to Oslo University Hospital. After multidisciplinary team evaluation, 230 patients were considered to have borderline resectable pancreatic cancer/locally advanced pancreatic cancer. The final study group consisted of 188 patients (borderline resectable pancreatic cancer n = 96, locally advanced pancreatic cancer n = 92) who were fit to receive primary chemotherapy. Resection rates were 46.9% (45 of 96) for borderline resectable pancreatic cancer and 13% (12 of 92) for locally advanced pancreatic cancer (P <0.001). Median overall survival was 14.6 months (borderline resectable pancreatic cancer 16.4 months; locally advanced pancreatic cancer 13.7 months, (P = 0.2)). Adjusted for immortal time bias, median overall survival for patients undergoing resection versus only chemotherapy was 24.4 months versus 10.1 months (P <0.001) for borderline resectable pancreatic cancer and 28.4 months versus 12.6 months for locally advanced pancreatic cancer (P = 0.001). CONCLUSION: Resection rates and survival in patients with borderline resectable pancreatic cancer and locally advanced pancreatic cancer treated at a high-volume centre in a universal healthcare system compare well with those treated at international expert centres.Registration number: NCT04423731 (http://www.clinicaltrials.gov).

MAPPinfo - mapping quality of health information: Validation study of an assessment instrument.

BACKGROUND: Health information is a prerequisite for informed choices-decisions, made by individuals about their own health based on knowledge and in congruence with own preferences. Criteria for development, content and design have been defined in a corresponding guideline. However, no instruments exist that provide reasonably operationalised measurement items. Therefore, we drafted the checklist, MAPPinfo, addressing the existing criteria with 19 items. OBJECTIVES: The current study aimed to validate MAPPinfo. METHODS: Five substudies were conducted subsequently at the Martin Luther University Halle-Wittenberg, Germany and the Medical University of Graz, Austria: (1) to determine content validity through expert reviews of the first draft, (2) to determine feasibility using 'think aloud' in piloting with untrained users, (3) to determine inter-rater reliability and criterion validity through a pretest on 50 health information materials, (4) to determine construct validity using 50 developers' self-declarations about development methods as a reference standard, (5) to determine divergent validity in comparison with the Ensuring Quality Information for Patients (EQIP) (expanded) Scale. The analyses used were qualitative methods and correlation-based methods for determining both inter-rater reliability and validity. RESULTS: The instrument was considered by experts to operationalise the existing guidelines convincingly. Health and nursing science students found it easy to understand and use. It also had good interrater reliability (mean of T coefficients = .79) and provided a very good estimate of the reference standard (Spearman's rho = .89), implying sound construct validity. Finally, comparison with the EQIP instrument revealed important and distinct areas of similarities and differences. CONCLUSIONS: The new instrument is ready for use as a screening instrument without the need for training. According to its underpinning concept the instrument exclusively comprises items which are justified by either ethics or research evidence, implying negligence of not yet evidence based, however, potentially important criteria. Further research is needed to complete the body of evidence-based criteria, aiming at an extension of the guideline and MAPPinfo. TRIAL REGISTRATION NUMBER: AsPredicted22546; date of registration: 24 July 2019.

Sleep duration in schooldays is associated with health-related quality of life in norwegian adolescents: a cross-sectional study.

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.

Infant colic and abdominal pain; associations with infant multimorbidity and maternal perceived stress up to 3 months postpartum-A cross-sectional/cohort study in the PreventADALL study.

AIMS AND OBJECTIVES: The primary aim was to explore whether infants with pain symptoms (colic, abdominal pain and visit to healthcare provider with pain or other discomforts) had increased multimorbidity (common infections, eczema and food sensitivity) compared with infants without these conditions. Secondarily, we aimed to determine whether infant pain symptoms were associated with maternal perceived stress in pregnancy and 3 months postpartum. BACKGROUND: Infant colic and abdominal pain are common concerns in early infancy. Nevertheless, to our knowledge, little research exists on the relationship between infant pain and common infant infections, eczema and food sensitization as comorbidities, and the impact of infant pain on the development of maternal perceived stress from pregnancy to infancy is inconsistent. DESIGN: This study was cross-sectional and partly prospective. METHODS: The sample consisted of mother-infant pairs (N = 1852); information regarding infant pain and multimorbidity was collected from the 3-month questionnaire and postpartum visits in the PreventADALL prospective cohort study. Chi-square tests and regression analyses were conducted. The STROBE checklist was followed. RESULTS: Our results showed a statistically significant higher proportion of respiratory and other infections in infants with pain symptoms. The odds of infant pain were higher for infants with multimorbidity compared to those with no comorbidity. Mothers of infants with colic and of infants visiting healthcare with pain and other discomforts reported statistically significant higher perceived stress by 3 months compared with mothers of infants with no reported pain. CONCLUSION: Our results indicate an association between infant pain symptoms and the presence of infections. Mothers of infants with colic and visiting healthcare had higher perceived stress compared to the no pain group. IMPLICATIONS FOR PRACTICE: Our study indicates that infant pain is associated with infant multimorbidity and maternal perceived stress, which may be useful when planning diagnostic, treatment and coping strategies in infant and family care. PATIENT OR PUBLIC CONTRIBUTION: The PreventADALL is a collaborative study with governmental and patient organisation representation. Selected infants with parents were also contributing during calibrating courses on eczema assessment for the data collectors. TRIAL REGISTRATION: The study was approved by the Regional Committee in Norway (2014/518) and Sweden (2014/2242-31/4) and registered at clinicaltrial.gov (NCT02449850). Link for clinical trials: https://clinicaltrials.gov/ct2/show/NCT02449850.

Symptoms and symptom clusters in patients newly diagnosed with inflammatory bowel disease: results from the IBSEN III Study.

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.

Incidence of cancer in patients with ulcerative colitis 30 years after diagnosis (the IBSEN study).

OBJECTIVES: Patients with ulcerative colitis (UC) have shown an increased risk for colorectal cancer, hepatobiliary, hematologic, and skin cancers, but updated long-term data is needed. This study aimed to estimate the risk of cancer in patients with UC compared to the general Norwegian population, in a population-based cohort (the IBSEN study), 30 years after diagnosis; and to identify possible risk factors associated with cancer. METHODS: The IBSEN cohort prospectively included all incident patients between 1990 and 1993. Cancer incidence data were obtained from the Cancer Registry of Norway. The overall and cancer-specific hazard ratios (HR) were modelled using Cox regression. Standardized incidence ratios were estimated compared to the general population. RESULTS: In total, the cohort included 519 patients, and 83 cases were diagnosed with cancer. There was no statistically significant difference in the overall cancer risk (HR = 1.01, 95% CI: [0.79-1.29]) and colorectal cancer risk (HR = 1.37, 95% CI: [0.75-2.47]) between patients and controls. The incidence of biliary tract cancer was higher than expected (SIR = 9.84, 95%CI: [3.19-20.15]), especially when UC patients suffered from primary sclerosing cholangitis. Male UC patients were also more at risk of being diagnosed with hematologic malignancies (HR = 3.48, 95% CI: [1.55-7.82]). Being prescribed thiopurines was associated with a higher risk of cancer (HR = 2.03, 95% CI: [1.02-4.01]). CONCLUSIONS: At 30 years after diagnosis, the risk of all cancer in patients with UC was not significantly increased compared with the general population. However, the risks of biliary tract cancer and hematologic cancers were increased, particularly in male patients.

Clinical and biochemical impact of vitamin B6 deficiency in primary sclerosing cholangitis before and after liver transplantation.

BACKGROUND AND AIMS: We previously demonstrated that people with primary sclerosing cholangitis (PSC) had reduced gut microbial capacity to produce active vitamin B6 (pyridoxal 5'-phosphate [PLP]), which corresponded to lower circulating PLP levels and poor outcomes. Here, we define the extent and biochemical and clinical impact of vitamin B6 deficiency in people with PSC from several centers before and after liver transplantation (LT). METHODS: We used targeted liquid chromatography-tandem mass spectrometry to measure B6 vitamers and B6-related metabolic changes in blood from geographically distinct cross-sectional cohorts totaling 373 people with PSC and 100 healthy controls to expand on our earlier findings. Furthermore, we included a longitudinal PSC cohort (n = 158) sampled prior to and serially after LT, and cohorts of people with inflammatory bowel disease (IBD) without PSC (n = 51) or with primary biliary cholangitis (PBC) (n = 100), as disease controls. We used Cox regression to measure the added value of PLP to predict outcomes before and after LT. RESULTS: In different cohorts, 17-38% of people with PSC had PLP levels below the biochemical definition of a vitamin B6 deficiency. The deficiency was more pronounced in PSC than in IBD without PSC and PBC. Reduced PLP was associated with dysregulation of PLP-dependent pathways. The low B6 status largely persisted after LT. Low PLP independently predicted reduced LT-free survival in both non-transplanted people with PSC and in transplant recipients with recurrent disease. CONCLUSIONS: Low vitamin B6 status with associated metabolic dysregulation is a persistent feature of PSC. PLP was a strong prognostic biomarker for LT-free survival both in PSC and recurrent disease. Our findings suggest that vitamin B6 deficiency modifies the disease and provides a rationale for assessing B6 status and testing supplementation. IMPACT AND IMPLICATIONS: We previously found that people with PSC had reduced gut microbial potential to produce essential nutrients. Across several cohorts, we find that the majority of people with PSC are either vitamin B6 deficient or have a marginal deficiency, which remains prevalent even after liver transplantation. Low vitamin B6 levels strongly associate with reduced liver transplantation-free survival as well as deficits in biochemical pathways dependent on vitamin B6, suggesting that the deficiency has a clinical impact on the disease. The results provide a rationale for measuring vitamin B6 and to investigate whether vitamin B6 supplementation or modification of the gut microbial community can help improve outcomes for people with PSC.

Fatigue in Patients with Newly Diagnosed Inflammatory Bowel Disease: Results from a Prospective Inception Cohort, the IBSEN III Study.

BACKGROUND AND AIMS: Although fatigue is common in inflammatory bowel disease [IBD], its pathogenesis remains unclear. This study aimed to determine the prevalence of fatigue and its associated factors in a cohort of patients newly diagnosed with IBD. METHODS: Patients ≥18 years old were recruited from the Inflammatory Bowel Disease South-Eastern Norway [IBSEN III] study, a population-based, observational inception cohort. Fatigue was assessed using the Fatigue Questionnaire and compared with data from a Norwegian general population. Univariate and multivariate linear and logistic regression analyses were performed to evaluate the associations of total fatigue [TF; continuous score] and substantial fatigue [SF; dichotomized score ≥4] with sociodemographic, clinical, endoscopic, laboratory, and other relevant patient data. RESULTS: In total, 983/1509 [65.1%] patients with complete fatigue data were included (ulcerative colitis [UC], 68.2%; Crohn's disease [CD], 31.8%). The prevalence of SF was higher in CD [69.6%] compared with UC [60.2%] [p < 0.01], and in both diagnoses when compared to the general population [p < 0.001]. In multivariate analyses, depressive symptoms, pain intensity, and sleep disturbances were associated with increased TF for both diagnoses. In addition, increased clinical disease activity and Mayo endoscopic score were significantly associated with TF in UC, whereas all disease-related variables were insignificant in CD. Similar findings were observed for SF, except regarding the Mayo endoscopic score. CONCLUSIONS: SF affects approximately two-thirds of patients newly diagnosed with IBD. Fatigue was associated with depressive symptoms, sleep disturbances, and increased pain intensity in both diagnoses, while clinical and endoscopic activity were associated factors only in UC.

Surgery in degenerative spondylolisthesis: does fusion improve outcome in subgroups? A secondary analysis from a randomized trial (NORDSTEN trial).

BACKGROUND CONTEXT: Patients with spinal stenosis and degenerative spondylolisthesis are treated surgically with decompression alone or decompression with fusion. However, there is debate regarding which subgroups of patients may benefit from additional fusion. PURPOSE: To investigate possible treatment effect modifiers and prognostic variables among patients operated for spinal stenosis and degenerative spondylolisthesis. DESIGN: A secondary exploratory study using data from the Norwegian Degenerative Spondylolisthesis and Spinal Stenosis (NORDSTEN-DS) trial. Patients were randomized to decompression alone or decompression with instrumented fusion. PATIENT SAMPLE: The sample in this study consists of 267 patients from a randomized multicenter trial involving 16 hospitals in Norway. Patients were enrolled from February 12, 2014, to December 18, 2017. The study did not include patients with degenerative scoliosis, severe foraminal stenosis, multilevel spondylolisthesis, or previous surgery. OUTCOME MEASURES: The primary outcome was an improvement of ≥ 30% on the Oswestry Disability Index score (ODI) from baseline to 2-year follow-up. METHODS: When investigating possible variables that could modify the treatment effect, we analyzed the treatment arms separately. When testing for prognostic factors we analyzed the whole cohort (both treatment groups). We used univariate and multiple regression analyses. The selection of variables was done a priori, according to the published trial protocol. RESULTS: Of the 267 patients included in the trial (183 female [67%]; mean [SD] age, 66 [7.6] years), complete baseline data for the variables required for the present analysis were available for 205 of the 267 individuals. We did not find any clinical or radiological variables at baseline that modified the treatment effect. Thus, none of the commonly used criteria for selecting patients for fusion surgery influenced the chosen primary outcome in the two treatment arms. For the whole cohort, less comorbidity (American Society of Anesthesiologists Classification [ASA], OR = 4.35; 95% confidence interval (CI [1.16-16.67]) and more preoperative leg pain (OR = 1.23; CI [1.02-1.50]) were significantly associated with an improved primary outcome. CONCLUSIONS: In this study on patients with degenerative spondylolisthesis, neither previously defined instability criteria nor other pre-specified baseline variables were associated with better clinical outcome if fusion surgery was performed. None of the analyzed variables can be applied to guide the decision for fusion surgery in patients with degenerative spondylolisthesis. For both treatment groups, less comorbidity and more leg pain were associated with improved outcome 2 years after surgery. TRIAL REGISTRATION: NORDSTEN-DS ClinicalTrials.gov, NCT02051374.

Modifiable factors associated with a consistently high acute pain trajectory after surgical treatment of traumatic fractures in Ethiopia: a multi-center prospective cohort study.

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.

Rehabilitation of Social Communication Skills in Patients With Acquired Brain Injury With Intensive and Standard Group Interactive Structured Treatment: A Randomized Controlled Trial.

OBJECTIVE: To determine the efficacy of group interactive structured treatment (standard GIST) for improving social communication difficulties in a wider acquired brain injury (ABI) population compared to a waitlist control (WL). Secondary objectives were to (a) explore GIST across delivery formats by comparing the results to an intensive inpatient version of GIST (intensive GIST) and (b) compare the within-subject results for WL and intensive GIST. DESIGN: Randomized controlled trial with WL and repeated measures (pre- and posttraining, 3- and 6-month follow-ups). SETTING: Community and rehabilitation hospital. PARTICIPANTS: Forty-nine persons (27-74 years) with ABI and social communication difficulties (26.5% traumatic brain injury, 44.9% stroke, 28.6% other), minimum 12 months postinjury. INTERVENTION: Standard GIST (n=24) consisted of 12 weekly outpatient interactive group sessions (2.5 hours/session) and follow-up. Intensive GIST (n=18) consisted of 4 weeks with daily 4-hour inpatient group sessions (2 × 3 d/wk, 2 × 4 d/wk) and follow-up. MAIN OUTCOME MEASURES: La Trobe Questionnaire, a self-report questionnaire measuring social communication. Secondary measures: Social Communication Skills Questionnaire-Adapted, Goal Attainment Scale, Mind in the Eyes test, and questionnaires addressing mental and cognitive health, self-efficacy, and quality of life. RESULTS: When comparing the standard GIST and WL results, a trend of improvement was found for the main outcome, La Trobe Questionnaire, and a statistically significant improvement was found for the secondary outcome Social Communication Skills Questionnaire-Adapted. Comparing standard GIST and intensive GIST, improvement in social communication skills after both treatments was detected and maintained at 6-month follow-up. No statistically significant difference was found between groups. Goal attainment was achieved and maintained during follow-up for both standard and intensive GIST. CONCLUSIONS: Social communication skills were improved after both standard and intensive GIST, indicating that GIST can be delivered across treatment formats and to a wider ABI population.

Effect of Godelieve Denys-Struyf (GDS) muscle and articulation chain treatment on clinical variables of patients with chronic low back pain and lumbar disc degeneration: a pilot feasibility randomized controlled trial.

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.

Individual supported work placements (ReISE) for improving sustained return to work in unemployed people with persistent pain: study protocol for a cohort randomised controlled trial with embedded economic and process evaluations.

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.

Quality of life in Norwegian pregnant women and men with pregnant partners, and association with perception of sleep and depressive symptoms: a cross-sectional study.

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 < 0.05. RESULTS: Pregnant women reported significantly lower QoL scores on the physical health and psychological domains than the men with pregnant partners. Our data did not reveal any moderating effect of depressive symptoms on the relationship between the perception of sleep and QoL. Depressive symptoms in the pregnant women were found to be a significant predictor of lower QoL in all domains. In the men with pregnant partners, getting enough sleep was a significant predictor of higher QoL in all domains. In the pregnant women without depressive symptoms, higher QoL in the physical health domain was significantly associated with the perception of getting enough sleep. CONCLUSION: Women in the final trimester of pregnancy experience poor QoL compared to the men with pregnant partners. Pregnant women with depressive symptoms have lower QoL compared to those without depressive symptoms. The perception of getting enough sleep was associated with better QoL.

Return to work during first year after intensive care treatment and the impact of demographic, clinical and psychosocial factors.

OBJECTIVES: To describe work participation in survivors during first year after intensive care unit discharge and examine the impact of selected demographic, clinical and psychosocial factors on return to work 12 months after discharge. RESEARCH METHODOLOGY/DESIGN: A predefined sub-study (prospective cohort study) of a randomised controlled trial. SETTING: A Norwegian single-centre university hospital. Medical and surgical adult intensive care survivors, working/on sick leave before admission, in the intensive care unit ≥24 h, were included. MAIN OUTCOME MEASURES: Return to work three, six and 12 months after discharge, and impact of age, pre-existing comorbidities, previous serious life events, coping ability, hope and social support on return to work 12 months after discharge. RESULTS: Included were 284 patients, with mean age 47 years (SD 13.9) and 47 % women. One year after discharge, 69 % were back at work. In the regression analysis, with working at 12 months (yes/no) as the dependent variable, 178 patients, completing questionnaires at three as well as 12 months, were included. Lower age (OR 0.96, 95 % CI [0.93-0.99]), lower pre-existing comorbidities (OR 0.65, 95 % CI [0.43-0.97]), previous serious life events (OR 6.53, 95 % CI [2.14-19.94]), and greater hope at three months (OR 1.09, 95 % CI [1.01-1.17]) were all independently associated with higher odds of returning to work. CONCLUSION: Following intensive care, age, pre-existing comorbidities, experience of previous serious life events and hope all have a significant impact on return to work, and are important variables to consider during intensive care treatment and rehabilitation. IMPLICATIONS FOR CLINICAL PRACTICE: Attention must be paid to patients with prior working capability to ensure return to work after intensive care treatment. Older adults with pre-existing comorbidities might benefit from early, individualised rehabilitation to regain previous working capacity. In addition, there is also a need to support patients' hope during and after critical illness.