Dietary intake and nutritional status in patients with newly diagnosed inflammatory bowel disease: insights from the IBSEN III study.

BACKGROUND: Dietary recommendations in inflammatory bowel disease (IBD) are inconclusive, and patients may follow restrictive diets with increased risk of malnutrition. The aim of this study was to compare dietary intakes and nutritional status in men and women with newly diagnosed IBD with a general population sample, and to investigate whether intakes were in line with the Nordic Nutrition Recommendations. METHODS: This was a cross-sectional study including adults≥ 40 years with IBD from the Inflammatory Bowel Disease in South-Eastern Norway (IBSEN) III cohort study. A validated food frequency questionnaire (FFQ) was used in dietary data collection, and a sample from the seventh survey of the Tromsø Study was included as a comparison group. RESULTS: A total of 227 men and women with IBD were included. IBD patients had higher intake of grain products, sweetened beverages, energy, fat and polyunsaturated fat (PUFA), but lower intake of dairy products, alcohol and iodine compared to adults from the comparison sample (p < 0.01). Intakes of saturated fat and carbohydrates in both genders, and vitamin D in women were not within recommended levels. Anemia and hypoalbuminemia were more prevalent in IBD patients than in the comparison sample. CONCLUSIONS: Dietary intakes in newly diagnosed IBD patients were mostly in line with Nordic Nutrition Recommendations. Higher proportion of IBD patients exceeded recommended allowances of fat and added sugar than the comparison sample. Insufficient micronutrient intake, anemia and hypoalbuminemia are present challenges in IBD patients that require monitoring.

Self-prescribed dietary restrictions in patients with inflammatory bowel disease (IBD) due to inconclusive dietary guidance may influence their risk of malnutrition. Comprehensive assessment of both dietary intake and nutritional status as early as time of diagnosis may help identify challenges in this patient group and implement appropriate interventions.

The effect of a music-based caregiving intervention on pain intensity in nursing home patients with dementia: a cluster-randomized controlled study.

ABSTRACT: Treatment of chronic pain in patients with dementia is challenging because they have reduced ability to report pain and are particularly vulnerable to side effects of analgesics. Different types of music-based therapy have been recommended and are used as an alternative to analgesics, but the evidence is lacking. Therefore, we performed a cluster-randomized controlled study (RCT) to reduce pain intensity using music-based caregiving (MBC) over 8 weeks in nursing home patients with dementia and chronic pain. We also investigated if the amount of MBC and different chronic pain syndromes would impact on the effect. Of the 645 patients, 498 patients from 36 wards in 12 nursing homes were screened for dementia and pain. Using the Clinical Dementia Rating Scale and the Mobilization-Observation-Behavior-Intensity-Dementia Pain Scale (range 0-10), 279 (71% females, 42% severe dementia) nursing home patients were randomized to intervention group (n = 134, 18 wards) or control group (n = 145, 18 wards). The main outcome was change in pain intensity before and after the intervention. The study did not reveal any effect of MBC on pain intensity when compared with the control group (B = -0.15, 95% CI [-0.72 to 0.43]). No significant difference was found within the intervention group analyzing the impact of intervention time (B = 0.73, 95% CI [-0.55 to 2.02]) or chronic primary vs secondary pain syndromes (B = 0.45, 95% CI [-0.05 to 0.96]). Our data from this first RCT on music and pain intensity in patients with dementia and chronic pain did not find an effect of MBC on pain.

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.

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.

Improvement of anxiety in ADHD following goal-focused cognitive remediation: a randomized controlled trial.

Introduction: Despite the high prevalence and detrimental consequences of cognitive and executive dysfunction in ADHD, the evidence base of cognitive remediation in the adult ADHD population is sparse. Executive problems can increase both anxiety and depression in ADHD. Thcus, it is important to develop treatment options for adults with ADHD, aiming to improve goal-directed behavior and mood. Goal Management Training (GMT) is an intervention that has received empirical support in improving executive functions and mood in normal aging and for various neurological and psychiatric conditions. The present randomized controlled trial investigated the effects of a goal-focused intervention combining 1) group-based GMT incorporating psychoeducation about ADHD and 2) guidance in implementing individual goals for coping with executive problems in everyday life, compared to treatment as usual (TAU). The primary outcome was perceived executive functioning in everyday life. Secondary outcomes included psychological well-being (anxiety, depression, and coping with ADHD symptoms). Methods: We recruited 81 adult participants with a verified ADHD diagnosis (Mage = 31 years). Inclusion was based upon the presence of executive functioning complaints. The participants were randomly assigned to either the intervention or TAU. The intervention group (n = 41) received 16 hours of GMT and psychoeducation, in addition to 4 individual sessions focusing on formulating goals. The goals were assessed in 6 bi-weekly phone calls in the first three months following the group sessions. Participants in the TAU group (n = 40) received standard, individually-adapted follow-up in an outpatient psychiatric health care setting. All participants were assessed at baseline, post-intervention, and at 8-month follow-up (main measurement time point). Results: Significant improvements in everyday executive functioning, psychological wellbeing, and symptoms of ADHD from baseline to 8-month follow-up were reported in both groups. The intervention group reported a significantly higher reduction in symptoms of anxiety compared to TAU. Conclusions. Our findings provide support for considering cognitive remediation as a treatment option for patients with ADHD.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT04638283?term=NCT04638283&rank=1, identifier: NCT04638283.

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.

Risk of Cancer in Patients With Crohn's Disease 30 Years After Diagnosis (the IBSEN Study).

Background: Patients with Crohn's disease (CD) are most often diagnosed as young adults; therefore, long-term studies are needed to assess the risk of cancer over their lifetime. Thus, the aims of the present study were to determine the risk of cancer in a Norwegian population-based cohort (the Inflammatory Bowel South Eastern Norway [IBSEN] study), 30 years after diagnosis, and to assess whether patients with CD were at an increased risk of specific cancer types. Methods: The IBSEN cohort prospectively included all incident patients diagnosed between 1990 and 1993. Data on cancer incidence were obtained from the Cancer Registry of Norway. Overall and cancer-specific hazard ratios (HRs) for CD patients compared with age- and sex-matched controls were modeled using Cox regression. Standardized incidence ratios (SIRs) were estimated compared to the general population. Results: In total, the cohort included 237 patients with CD, and 36 of them were diagnosed with cancer. Compared to the general Norwegian population, patients with CD had an increased overall risk of cancer (HR = 1.56, 95% CI: 1.06-2.28), particularly male patients (HR = 1.85, 95% CI: 1.08-3.16). The incidence of lung cancer and nonmelanoma skin cancer was increased; however, the difference was not statistically significant (SIR = 2.29, 95% CI: 0.92-4.27 and SIR = 2.45, 95% CI: 0.67-5.37, respectively). Conclusions: After 30 years of follow-up, the risk of all cancers in patients with CD was increased compared to the general population.

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.

Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial.

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

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.

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.

Patient-reported outcomes, weight loss, and remission of type 2 diabetes 3 years after gastric bypass and sleeve gastrectomy (Oseberg); a single-centre, randomised controlled trial.

BACKGROUND: Little is known about the comparative effects of various bariatric procedures on patient-reported outcomes. We aimed to compare 3-year effects of gastric bypass and sleeve gastrectomy on patient-reported outcome measures in patients with obesity and type 2 diabetes. METHODS: The Oseberg trial was a single-centre, parallel-group, randomised trial at Vestfold Hospital Trust, a public tertiary obesity centre in Tønsberg, Norway. Eligible patients were aged 18 years or older with previously verified BMI 35·0 kg/m2 or greater. Diabetes was diagnosed if glycated haemoglobin was at least 6·5% (48 mmol/mol) or by their use of anti-diabetic medications with glycated haemoglobin at least 6·1% (43 mmol/mol). Eligible patients were randomly assigned (1:1) to gastric bypass or sleeve gastrectomy. All patients received identical preoperative and postoperative treatment. Randomisation was done with a computerised random number generator and a block size of ten. Study personnel, patients, and the primary outcome assessor were blinded to allocations for 1 year. The prespecified secondary outcomes reported here were 3-year changes in several clinically important patient-reported outcomes, weight loss, and diabetes remission. Analyses were done in the intention to treat population. This trial is ongoing, closed to recruitment and is registered with ClinicalTrials.gov, NCT01778738. FINDINGS: Between Oct 15, 2012 and Sept 1, 2017, 319 consecutive patients with type 2 diabetes scheduled for bariatric surgery were assessed for eligibility. 101 patients were not eligible (29 did not have type 2 diabetes according to inclusion criteria and 72 other exclusion criteria) and 93 declined to participate. 109 patients were enrolled and randomly assigned to sleeve gastrectomy (n=55) or gastric bypass (n=54). 72 (66%) of 109 patients were female and 37 (34%) were male. 104 (95%) of patients were White. 16 patients were lost to follow up and 93 (85%) patients completed the 3-year follow-up. Three additional patients were contacted by phone for registration of comorbidities Compared with sleeve gastrectomy, gastric bypass was associated with a greater improvement in weight-related quality of life (between group difference 9·4, 95% CI 3·3 to 15·5), less reflux symptoms (0·54, 0·17 to -0·90), greater total bodyweight loss (8% difference, 25% vs 17%), and a higher probability of diabetes remission (67% vs 33%, risk ratio 2·00; 95% CI 1·27 to 3·14). Five patients reported postprandial hypoglycaemia in the third year after gastric bypass versus none after sleeve-gastrectomy (p=0·059). Symptoms of abdominal pain, indigestion, diarrhoea, dumping syndrome, depression, binge eating, and appetitive drive did not differ between groups. INTERPRETATION: At 3 years, gastric bypass was superior to sleeve gastrectomy in patients with type 2 diabetes and obesity regarding weight related quality of life, reflux symptoms, weight loss, and remission of diabetes, while symptoms of abdominal pain, indigestion, diarrhoea, dumping, depression and binge eating did not differ between groups. This new patient-reported knowledge can be used in the shared decision-making process to inform patients about similarities and differences between expected outcomes after the two surgical procedures. FUNDING: Morbid Obesity Centre, Vestfold Hospital Trust. TRANSLATION: For the Norwegian translation of the abstract see Supplementary Materials section.

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.

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.