Health-related quality of life in patients with newly diagnosed inflammatory bowel disease: an observational prospective cohort study (IBSEN III).

PURPOSE: This unselected, population-based cohort study aimed to determine the level of health-related quality of life (HRQoL) in patients with Crohn's disease (CD) and ulcerative colitis (UC) at the time of diagnosis compared with a reference population and identify the demographic factors, psychosocial measures, and disease activity markers associated with HRQoL. METHODS: Adult patients newly diagnosed with CD or UC were prospectively enrolled. HRQoL was measured using the Short Form 36 (SF-36) and Norwegian Inflammatory Bowel Disease Questionnaires. Clinical significance was assessed using Cohen's d effect size and further compared with a Norwegian reference population. Associations between HRQoL and symptom scores, demographic factors, psychosocial measures, and disease activity markers were analyzed. RESULTS: Compared with the Norwegian reference population, patients with CD and UC reported significantly lower scores in all SF-36 dimensions, except for physical functioning. Cohen's d effect sizes for men and women in all SF-36 dimensions were at least moderate, except for bodily pain and emotional role for men with UC and physical functioning for both sexes and diagnoses. In the multivariate regression analysis, depression subscale scores ≥ 8 on the Hospital Anxiety and Depression Scale, substantial fatigue, and high symptom scores were associated with reduced HRQoL. CONCLUSION: Patients newly diagnosed with CD and UC reported statistically and clinically significantly lower scores in seven of the eight SF-36 dimensions than the reference population. Symptoms of depression, fatigue, and elevated symptom scores were associated with poorer HRQoL.

Characteristics of nonparticipants in a randomised colorectal cancer screening trial comparing sigmoidoscopy and faecal immunochemical testing.

Public health systems should guarantee universal access to health care services, including cancer screening. We assessed whether certain population subgroups were underrepresented among participants in colorectal cancer screening with sigmoidoscopy and faecal immunochemical testing (FIT). Between 2012 and 2019, about 140 000 individuals aged 50 to 74 years were randomly invited to once-only sigmoidoscopy or first round of FIT screening. Our study included 46 919 individuals invited to sigmoidoscopy and 70 019 to FIT between 2012 and 2017. We used logistic regression models to evaluate if demographic and socioeconomic factors and use of certain drugs were associated with participation. Twenty-four thousand one hundred and fifty-nine (51.5%) individuals attended sigmoidoscopy and 40 931 (58.5%) FIT screening. Male gender, young age, low education and income, being retired or unemployed, living alone, being an immigrant, long driving time to screening centre, and use of antidiabetic and psychotropic drugs were associated with low participation in both screening groups. Many of these factors also predicted low acceptance of colonoscopy after positive FIT. While male gender, young age and living alone were more strongly associated with nonparticipation in FIT than sigmoidoscopy, low education and income, being retired or immigrant and long driving time were more strongly associated with nonparticipation in sigmoidoscopy than FIT. In conclusion, participation was lower in sigmoidoscopy than FIT. Predictors of nonparticipation were similar between arms. However, low socioeconomic status, being an immigrant and long driving time affected participation more in sigmoidoscopy screening, suggesting that FIT may guarantee more equal access to screening services than sigmoidoscopy.

The multidimensional fatigue inventory (MFI-20): psychometrical testing in a Norwegian sample of inflammatory bowel disease (IBD) patients.

OBJECTIVES: To evaluate the psychometric properties of the Norwegian version of the multidimensional fatigue inventory (MFI-20) in patients with inflammatory bowel disease. METHODS: Participants were recruited from nine hospitals in the southeastern and western parts of Norway. Clinical and sociodemographic data were collected, and participants completed the MFI-20, as well as the Fatigue Questionnaire (FQ). In addition to a confirmatory factor analysis, validity, reliability, test-retest and responsiveness were evaluated. RESULTS: In total, 410 patients were included. The Norwegian MFI-20 had an acceptable model fit when compared to the original five-dimensional structure. A positive correlation was observed between the dimensions of MFI-20 and the FQ. MFI-20 scores increased according to subjective disease activity, but no differences were observed when using a calprotectin cut-off < or > =250 µg/g mg/kg. All MFI-20 dimensions except 'reduced motivation' in both ulcerative colitis (UC) and Crohn's disease (CD) patients had alpha Cronbach alpha values ≥70, and test-retest reliability revealed good to excellent values. Merely one dimension (Reduced activity) in UC patients reporting improvement did not reach the threshold for acceptable responsiveness according to Guyatt statistics. CONCLUSIONS: The Norwegian version of MFI-20 is valid, reliable and responsive. The instrument can safely be used in studies using fatigue as an endpoint.

Effect of aerobic exercise intensity on health-related quality of life in severe obesity: a randomized controlled trial.

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

Comparing the use of patient-reported outcomes in clinical studies in Europe in 2008 and 2018: a literature review.

PURPOSE: Several guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specific criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted. METHODS: A literature search was conducted in MEDLINE to identify eligible publications. To assess the number of publications, all abstracts were screened for eligibility by pairs of reviewers. Compliance with PRO-specific criteria and other key characteristics was assessed in a random sample of 150 eligible full-text publications from each year. Randomized controlled trials (RCTs) were assessed according to the full CONSORT-PRO checklist. RESULTS: The search identified 1692 publications in 2008 and 4290 in 2018. After screening of abstracts, 1240 from 2008 and 2869 from 2018 were clinical studies using PROs. By full-text review, the proportion of studies discussing PRO-specific limitations and implications was higher in 2018 than in 2008, but there were no differences in the other selected PRO-specific criteria. In 2018, a higher proportion of studies were longitudinal/cohort studies, included ≥ 300 patients, and used electronic administration of PRO than in 2008. The most common patient groups studied were those with cancer or diseases of the musculoskeletal system or connective tissue. CONCLUSION: The number of clinical studies from Europe using PROs was higher in 2018 than in 2008, but there was little difference in compliance with the PRO-specific criteria. The studies varied in terms of study design and PRO instruments used in both publication years.

Self-esteem in patients with inflammatory bowel disease.

PURPOSE: The purpose of this study was to explore self-esteem and associations between self-esteem and sociodemographic, clinical, and psychological factors in patients with inflammatory bowel disease (IBD), a disease of chronic relapsing inflammation of the gastrointestinal tract. IBD symptoms, including pain, fatigue, and diarrhea, as well as potential life-long medical treatment and surgery, may be demanding, cause significant challenges, and influence self-esteem. METHODS: In this cross-sectional multicenter study, participants were recruited from nine hospitals in the southeastern and western regions of Norway from March 2013 to April 2014. Data were collected using self-report questionnaires. Self-esteem was assessed by the Rosenberg Self-Esteem Scale, fatigue was assessed by the Fatigue Questionnaire, self-efficacy was assessed by the General Self-Efficacy Scale, and disease activity was assessed by the Simple Clinical Colitis Activity Index for ulcerative colitis (UC) and Harvey Bradshaw Index for Crohn's disease (CD). Multiple linear regression analysis was applied to examine associations between self-esteem and sociodemographic, clinical, and psychological factors. RESULTS: In total, 411 of 452 (91%) patients had evaluable data and were included in this study. The mean scores on self-esteem, self-efficacy, total fatigue, anxiety, and depression were similar between UC patients and CD patients. Male gender, being employed, and higher self-efficacy were independently associated with higher self-esteem, whereas anxiety and depression were independently associated with lower self-esteem. Neither disease activity nor fatigue were associated with self-esteem in the final multiple regression analyses. CONCLUSION: Patient-centered interventions that improve self-esteem and reduce anxiety and depression seem to be important to optimize IBD management.

Thyroidectomy Versus Medical Management for Euthyroid Patients With Hashimoto Disease and Persisting Symptoms: A Randomized Trial.

Background: Hashimoto disease is a chronic autoimmune thyroiditis. Despite adequate hormone substitution, some patients have persistent symptoms that may be the result of immunologic pathophysiology. Objective: To determine whether thyroidectomy improves symptoms in patients with Hashimoto thyroiditis who still have symptoms despite having normal thyroid gland function while receiving medical therapy. Design: Randomized trial. (ClinicalTrials.gov: NCT02319538). Setting: Secondary care hospital in Norway. Patients: 150 patients aged 18 to 79 years with persistent Hashimoto-related symptoms despite euthyroid status while receiving hormone replacement therapy and with serum antithyroid peroxidase (anti-TPO) antibody titers greater than 1000 IU/mL. Intervention: Total thyroidectomy or medical management with hormone substitution to secure euthyroid status in both groups. Measurements: The primary outcome was general health score on the Short Form-36 Health Survey (SF-36) at 18 months. Secondary outcomes were adverse effects of surgery, the other 7 SF-36 subscores, fatigue questionnaire scores, and serum anti-TPO antibody titers at 6, 12, and 18 months. Results: During follow-up, only the surgical group demonstrated improvement: Mean general health score increased from 38 to 64 points, for a between-group difference of 29 points (95% CI, 22 to 35 points) at 18 months. Fatigue score decreased from 23 to 14 points, for a between-group difference of 9.3 points (CI, 7.4 to 11.2 points). Chronic fatigue frequency decreased from 82% to 35%, for a between-group difference of 39 percentage points (CI, 23 to 53 percentage points). Median serum anti-TPO antibody titers decreased from 2232 to 152 IU/mL, for a between-group difference of 1148 IU/mL (CI, 1080 to 1304 IU/mL). In multivariable regression analyses, the adjusted treatment effects remained similar to the unadjusted effects. Limitation: Results are applicable only to a subgroup of patients with Hashimoto disease, and follow-up was limited to 18 months. Conclusion: Total thyroidectomy improved health-related quality of life and fatigue, whereas medical therapy did not. This improvement, along with concomitant elimination of serum anti-TPO antibodies, may elucidate disease mechanisms. Primary Funding Source: Telemark Hospital.

Defining the cut-off point of clinically significant postoperative fatigue in three common fatigue scales.

PURPOSE: Postoperative fatigue (POF) is an often underestimated problem after surgery. Studies on POF often report fatigue scores without relating this to the clinical relevance for the patients. The aim of this study was to define the cut-off point for clinically significant POF in three commonly applied fatigue scales; the Postoperative Fatigue Scale, Christensen's Fatigue Scale, and the Chalder Fatigue Questionnaire. The identification of cut-off points will make it possible to indicate whether statistically significant findings of increased fatigue are of clinical relevance. METHODS: We combined data from day 0 (pre-operatively) and day 1, 3, 6, and 30 after surgery in two fatigue-related studies with 442 patients. In order to define clinically significant fatigue, a key question was added in each questionnaire; "Given your current description of fatigue, would you say it has been of considerable significance to you?"; "Yes/No". We analysed each scale's ability to identify clinically significant fatigue, by performing receiver-operating characteristics (ROC) analyses, and calculated the optimal cut-off point between Sensitivity and Specificity. RESULTS: The average weighted cut-off point for clinically significant POF when measured with the Postoperative Fatigue Scale was ≥ 50 (scale range 0-100), with Christensen's Fatigue Scale ≥ 6 (scale range 1-10) and with the Chalder Fatigue Questionnaire ≥ 16 (scale range 0-33). CONCLUSION: In three commonly used fatigue scales, we have identified cut-off points for clinically significant fatigue among patients recovering from surgery. This can be particularly valuable for diagnostic purposes and in treatment evaluation. Further, it may be possible to analyse and review data from earlier studies in light of clinical relevance.

Changes in health-related quality of life in older candidates waiting for kidney transplantation.

AIM: There is limited available knowledge regarding health-related quality of life (HRQoL) in older patients with chronic kidney disease. We aimed to describe HRQoL in renal transplant candidates 65 years or older at transplant acceptance, and during the first year on the waiting list. METHODS: A nationwide prospective observational study in Norway was conducted. HRQoL was evaluated at baseline (wait listing) and after 6 and 12 months using the patient self-reported Kidney Disease and Quality of Life Short form version 1.3. Intra-individual scores at different times were evaluated. Generic HRQoL was compared with scores from an age-matched Norwegian population. RESULTS: From January 2013 to November 2016, 261 patients ≥65 years accepted for deceased donor kidney transplantation were included. Mean age at inclusion was 71.1 years, 67% male and 69% were on dialysis. HRQoL sum scores significantly decreased during the first year on the waiting list. Physical, mental and kidney disease component summary score reduced from 39.6 to 38.1 (P = 0.045), 48.8 to 44.7 (P < 0.001) and 72.1 to 70.2 (P = 0.03), respectively. When evaluating each domain separately, only the decrease in social function was clinically significant. Age and being on dialysis were the most important predictors for low HRQoL. Compared to the age-matched general population, males had significant lower HRQoL scores. Females were comparable to the general female population at baseline except in general health and vitality. CONCLUSIONS: HRQoL in older patients waiting for kidney transplantation decreases during the first year on the waiting list, but only the change in social function is clinically significant.

Lifestyle predictors for non-participation and outcome in the second round of faecal immunochemical test in colorectal cancer screening.

BACKGROUND: To reduce colorectal cancer (CRC) mortality through population-based screening programmes using faecal tests, it is important that individuals continue to participate in the repeated rounds of screening. We aimed to identify lifestyle predictors for discontinuation of faecal immunochemical test (FIT) screening after the first round, as well as lifestyle predictors for colorectal neoplasia detected in the second-round FIT screening. METHODS: In this longitudinal study, we invited 6959 individuals aged 50-74 years from south-east Norway for a first round of FIT screening and to complete a self-reported lifestyle questionnaire on demographic factors, body mass index (BMI, kg m-2), smoking habits, physical activity, consumption of alcohol and dietary items. Two years later, we estimated the associations between these factors, non-participation and screening results in the second round of FIT screening using adjusted odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Of the 3114 responders to the questionnaire who completed the first-round FIT and who were invited to participate in second-round FIT screening, 540 (17%) did not participate. The OR and (95% CI) for discontinuation of FIT screening after the first round was 1.61 (1.24-2.10) for current smoking compared with non-smoking; 2.01 (1.25-3.24) for BMI⩾35 kg m-2 compared with BMI 16.9-24.9 kg m-2 and 0.70 (0.52-0.94) for physical activity in the third quartile vs the first. Among participants, smoking, high BMI and high alcohol consumption were associated with an increased odds of detecting colorectal neoplasia (n=107). CONCLUSIONS: These results may indicate that Norwegian FIT screening participants who discontinue after the first round have lifestyle behaviours associated with increased risk of CRC.

Acceptability of two colorectal cancer screening tests: pain as a key determinant in sigmoidoscopy.

Background Participants' experience with a screening test can influence adherence, and therefore the efficacy of screening programs. We compared screening with unsedated flexible sigmoidoscopy and fecal immunochemical testing (FIT) for participants' satisfaction with the decision and for willingness to repeat colorectal cancer screening. Methods In a prospective, randomized trial 3257 individuals (50 - 74 years) were invited to either flexible sigmoidoscopy or FIT (1:1), of whom 1650 took up the offer (52.6 %). In total, 1497 screening participants completed at least one questionnaire, either before screening, and/or at three time points in the following year, that measured willingness to repeat screening, willingness to recommend screening, and satisfaction with decision to attend. There were 769 and 728 responders in the flexible sigmoidoscopy and FIT group, respectively. Additionally, 581 flexible sigmoidoscopy participants also completed a pain questionnaire. Results 1 year later, 10 % of the flexible sigmoidoscopy participants were not willing to repeat screening, compared to 5 % of FIT participants. A higher percentage of women compared to men would not repeat flexible sigmoidoscopy screening (adjusted odds ratio [OR] 2.52, 95 % confidence interval [95 %CI] 1.48 to 4.28). Notably, 22 % of women reported pain during flexible sigmoidoscopy compared to 5 % of men. When we added pain to the statistical model, pain was significantly associated with unwillingness to repeat flexible sigmoidoscopy (OR 3.15, 95 %CI 1.68 to 5.87), while gender was no longer associated (OR 1.53, 95 %CI 0.82 to 2.88). Conclusion Acceptability for flexible sigmoidoscopy and for FIT was high among Norwegian screening participants, though FIT participants were more willing to repeat screening. Women were less willing to repeat screening with flexible sigmoidoscopy compared to men. This gender difference seemed partly due to pain, and therefore preventable.This study is registered at ClinicalTrials.gov: NCT01538550.

Fatigue in a population-based cohort of patients with inflammatory bowel disease 20 years after diagnosis: The IBSEN study.

OBJECTIVE: Fatigue is a major concern for patients with ulcerative colitis (UC) and Crohn's disease (CD), but evidence from population-based studies regarding fatigue in long-standing inflammatory bowel disease (IBD) patients is scarce. Our aims were to assess fatigue scores and the prevalence of chronic fatigue in IBD patients 20 years after diagnosis and to identify variables associated with fatigue in this cohort. METHODS: Twenty years after diagnosis, patients from a cohort with incident IBD were invited to a follow-up visit that included a structured interview, a clinical examination, laboratory tests and the Fatigue Questionnaire (FQ). Fatigue scores were obtained, and factors associated with fatigue were assessed via linear and logistic regression analyses. RESULTS: Of the 599 invited patients, 440 (73.5%) completed the FQ. Among those with active disease, we found significantly higher fatigue scores than among those with quiescent disease (fatigue scores: UC 17.1 versus 12.4, p < .001, and CD 17.5 versus 13.3, p < .001). The fatigue scores of those with quiescent disease were comparable with those of the reference population. Chronic fatigue was more frequent among IBD patients than in the reference population. Factors associated with fatigue included self-perceived disease activity, poor sleep quality, anxiety and depression. CONCLUSION: At 20 years after IBD diagnosis, fatigue scores were higher and chronic fatigue was more frequent among IBD patients with active disease than in the reference population and among those with quiescent IBD. Subjectively perceived disease activity, sleep quality, anxiety and depression were associated with fatigue in IBD patients.

Vitamin D deficiency in inflammatory bowel disease: prevalence and predictors in a Norwegian outpatient population.

BACKGROUND AND AIM: Vitamin D deficiency is common in inflammatory bowel disease (IBD). The aims of the present study were to determine the prevalence of vitamin D deficiency and to identify clinical and epidemiological variables associated with vitamin D deficiency in an outpatient population with IBD. METHODS: Participants were recruited from nine hospitals in the southeastern and western regions of Norway as part of an observational, multicentre study from March 2013 to April 2014. Clinical and epidemiological data were collected by interview and from medical records. All analyses of serum 25-hydroxyvitamin D (25-OH-D) were performed in the same laboratory. RESULTS: In total, 49% (200/408) of the patients had a 25-OH-D concentration <50 nmol/L, including 53% (122/230) of the Crohn's disease (CD) patients and 44% (78/178) of the ulcerative colitis (UC) patients. In CD patients, disease activity, measured as the HBI, was inversely associated with vitamin D deficiency. No such association was observed with the Simple Clinical Colitis Activity Index (SCCAI) scores in UC, but in UC patients, vitamin D deficiency was associated with elevated faecal calprotectin >100 mg/kg. In patients with CD, there were significantly more relapses during the previous year in patients with vitamin D deficiency. CONCLUSIONS: Vitamin D deficiency was common, especially in CD, and was associated with increased disease activity, a relapsing disease course and higher inflammatory activity.

Do no harm: no psychological harm from colorectal cancer screening.

BACKGROUND: Participation in cancer screening programmes might cause worries in the population outweighting the benefits of reduced mortality. The present study aimed to investigate possible psychological harm of participation in a colorectal cancer (CRC) screening pilot in Norway. METHODS: In a prospective, randomised trial participants (aged 50-74 years) were invited to either flexible sigmoidoscopy (FS) screening, faecal immunochemical test (FIT), or no screening (the control group; 1 : 1: 1). Three thousand two hundred and thirteen screening participants (42% of screened individuals) completed the Hospital Anxiety and Depression Scale questionnaire as well as the SF-12-a health-related quality of life (HRQOL) questionnaire when invited to screening and when receiving the screening result. A control group was invited to complete the questionnaires only. Two thousand six hundred and eighteen control participants (35% of invited individuals) completed the questionnaire. RESULTS: A positive screening result did not increase participants' level of anxiety or depression, or decrease participants' level of HRQOL. Participants who received a negative result reported decreased anxiety and improvement on some HRQOL dimensions. However, no change was considered to be of clinical relevance. CONCLUSION: The current study showed no clinically relevant psychological harm of receiving a positive CRC screening result or of participating in FS or FIT screening, in a Norwegian population.

Patients' perceptions of quality of care and follow-up in inflammatory bowel disease.

BACKGROUND AND AIMS: Quality of care (QoC) has gained increased attention in IBD. A better QoC has, historically, been linked to improved treatment outcomes. Even so, factors of equal importance to patients may be quality of life (QoL), patient-physician communication and access to care. Recent surveys suggest that IBD care in Europe is suboptimal. METHODS: Patients were recruited from nine hospitals in the south-eastern and western part of Norway as a part of an observational, multicenter study In addition to clinical and socio-demographic factors; a purposely designed 26 item questionnaire was used to quantify aspects related to IBD care, including QoC. Moreover, the Fatigue Questionnaire (FQ) was used to investigate fatigue. RESULTS: In total, 411 patients were included. Of these, 231 were diagnosed with CD and 180 with UC. Furthermore, 86.1% (354/411) were satisfied with the quality of IBD follow-up and only 4.1% (17/411) were dissatisfied. Most dissatisfaction was related to: lack of focus on personal relations (18.2%), HRQoL (15.1%), general practitioner knowledge of IBD (13.9%), ability to talk about important topics (7.8%), and hospital discharge communication (9.4%). Higher age and longer disease duration was associated with improved QoC scores in both UC and CD. Fatigue was associated with decreased QoC scores in both diagnoses. CONCLUSIONS: Patients are satisfied with quality of care in IBD. However, communication seems to be an important area of improvement - not only related to patient-physician communication, but also to transitional communication between different health-care levels.

Extraintestinal manifestations in Crohn's disease and ulcerative colitis: results from a prospective, population-based European inception cohort.

BACKGROUND: In chronic inflammatory bowel disease (IBD) (Crohn's disease [CD] and ulcerative colitis [UC]), symptoms from outside the gastrointestinal tract are frequently seen, and the joints, skin, eyes, and hepatobiliary area are the most usually affected sites (called extraintestinal manifestations [EIM]). The reported prevalence varies, explained by difference in study design and populations under investigation. The aim of our study was to determine the prevalence of EIM in a population-based inception cohort in Europe and Israel. METHODS: IBD patients were incepted into a cohort that was prospectively followed from 1991 to 2004. A total of 1145 patients were followed for 10 years. RESULTS: The cumulative prevalence of first EIM was 16.9% (193/1145 patients) over a median follow-up time of 10.1 years. Patients with CD were more likely than UC patients to have immune-mediated (arthritis, eye, skin, and liver) manifestations: 20.1% versus 10.4% (p < 0.001). Most frequently seen was arthritis which was significantly more common in CD (12.9%) than in UC (8.1%), p = 0.01. Pan-colitis compared to proctitis in UC increased the risk of EIM. CONCLUSION: In a European inception cohort, EIMs in IBD were consistent with that seen in comparable studies. Patients with CD are twice as likely as UC patients to experience EIM, and more extensive distribution of inflammation in UC increases the risk of EIM.

The COMFORT behavioural scale provides a useful assessment of sedation, pain and distress in toddlers undergoing minor elective surgery.

AIM: The COMFORT behavioural scale was developed to assess sedation, pain and distress in children unable to report pain. Our aims were to test construct validity of the scale in toddlers undergoing minor surgery and determine the inter-rater reliability of the scale. METHODS: We consecutively enrolled 45 children aged 12-36 months from a Norwegian surgical outpatient care unit. The level of sedation, pain and distress was assessed before and after surgery with the COMFORT behavioural scale. Inter-rater reliability was estimated and construct validity was tested based on a priori defined hypotheses. A 2.5-point (15%) change in the scale was considered clinically important. RESULTS: We obtained 307 scores covering most of the scale's range, but a floor effect was clearly present. Inter-rater reliability was high between assessors (intraclass correlation coefficient = 0.96; 95% CI 0.92-0.98). Clinically important differences were seen between baseline and light sedation (3.1 points, p < 0.001) and between light and deep sedation (4.6 points, p = 0.002). The difference between baseline and our definition of a pain/distress state was not clinically important (1.5 points, p = 0.039). CONCLUSION: The COMFORT behavioural scale can provide one aspect of an overall clinical assessment of sedation, and probably pain and distress, in toddlers before and after surgery.

Thromboembolism in inflammatory bowel disease: results from a prospective, population-based European inception cohort.

BACKGROUND: Patients with inflammatory bowel disease (IBD) have proven an increased risk of venous thromboembolism (VTE), particularly when hospitalized. The estimate of the true risk varies considerably between studies, primarily due to differences in methodology. We set out to determine the incidence of VTE in a population-based European inception cohort. METHODS: IBD patients were incepted into a cohort that was prospectively followed from the early 1990s to the early 2000s. A total of 1145 patients were followed for a total of 10,634 patient-years (p.y.). RESULTS: A total of 19 thromboembolic events were identified - 13 deep vein thrombosis and 6 with pulmonary embolism. The incidence rate of VTE was 1.8 per 1000 p.y. CONCLUSION: The risk of VTE was elevated in this IBD cohort but lower than previously reported. The highest risk was seen in hospitalized patients, but corticosteroids-requiring disease in outpatients also conferred some risk.

Fatigue interference with daily living among patients with inflammatory bowel disease.

PURPOSE: The purpose of the study was to examine fatigue interference with daily living in patients with inflammatory bowel disease (IBD) and to explore relationships between severe fatigue interference and socio-demographic and clinical variables, including use of complementary and alternative medicine (CAM). METHODS: Data were collected using self-report questionnaires from adult IBD outpatients. Fatigue interference was assessed with the 5-item Fatigue Severity Scale, and scores ≥ 5 were defined as severe fatigue interference. CAM use was assessed with the International CAM Questionnaire. Multivariate logistic regression analysis was used to examine associations between severe fatigue interference and socio-demographic factors, clinical factors, and CAM use. RESULTS: In total, 428 patients had evaluable questionnaires (response rate 93 %). Severe fatigue interference was reported by 39 % of the total sample. Patients with Crohn's disease (CD) (n = 238) were more likely than patients with ulcerative colitis (UC) (n = 190) to report severe fatigue interference (43 and 33 %, respectively, p = 0.003). In addition, patients reporting severe fatigue interference were more likely to have active disease than patients without severe fatigue interference (p < 0.001 for both diagnoses). Patients with inactive disease had scores comparable to the general population. Factors independently associated with severe fatigue interference in UC included disease activity and CAM use, while in CD they included disease activity and current smoking. CONCLUSIONS: Severe fatigue interference is common among IBD patients with active disease. Among patients with UC, but not CD, CAM use was associated with severe fatigue interference. The relationship between fatigue interference and personal factors should be considered further in subsequent studies.