Tomm Bernklev

Clinical course during the first 10 years of ulcerative colitis: results from a population-based inception cohort (IBSEN Study)

Objective. Cohort studies of unselected and newly diagnosed patients are essential for a better understanding of the prognosis in ulcerative colitis (UC). The aim of this study was to evaluate the course of UC in a population-based inception cohort during the first 10 years, and to identify prognostic risk factors based on information gathered at diagnosis. Material and methods. From 1990 to 1994, a population-based cohort of 843 patients with inflammatory bowel disease was enrolled in South-Eastern Norway. The cohort was systematically followed-up at 1, 5 and 10 years after diagnosis. Results. Of 519 patients with UC, 423 completed the 10-year follow-up, 53 died and 43 were lost to follow-up. The mortality risk was not increased compared with that in the general population. The cumulative colectomy rate after 10 years was 9.8% (95% CI: 7.4–12.4%). Initial presentation with extensive colitis and erythrocyte sedimentation rate (ESR) ≥30 mm/h was associated with an increased hazard ratio (HR) (3.57, 95% CI: 1.60–7.96) and age ≥50 years at diagnosis, with reduced HR (0.28, 95% CI: 0.12–0.65) for subsequent colectomy. Relapsing disease was noted in 83%, but half (48%) of the patients were relapse free during the last 5 years. One-fifth (69/288) of patients with proctitis or left-sided colitis had progressed to extensive colitis. Conclusions. The prognosis for UC during the first 10 years was generally good. The colectomy rate was low, and a large proportion of patients were in remission as time progressed. Patients with initially extensive colitis and elevated ESR could benefit from an early potent medical treatment strategy.

Phenotype at diagnosis predicts recurrence rates in Crohn’s disease

Background: In Crohn’s disease (CD), studies associating phenotype at diagnosis and subsequent disease activity are important for patient counselling and health care planning. Aims: To calculate disease recurrence rates and to correlate these with phenotypic traits at diagnosis. Methods: A prospectively assembled uniformly diagnosed European population based inception cohort of CD patients was classified according to the Vienna classification for disease phenotype at diagnosis. Surgical and non-surgical recurrence rates throughout a 10 year follow up period were calculated. Multivariate analysis was performed to classify risk factors present at diagnosis for recurrent disease. Results: A total of 358 were classified for phenotype at diagnosis, of whom 262 (73.2%) had a first recurrence and 113 patients (31.6%) a first surgical recurrence during the first 10 years after diagnosis. Patients with upper gastrointestinal disease at diagnosis had an excess risk of recurrence (hazard ratio 1.54 (95% confidence interval (CI) 1.13–2.10)) whereas age ⩾40 years at diagnosis was protective (hazard ratio 0.82 (95% CI 0.70–0.97)). Colonic disease was a protective characteristic for resective surgery (hazard ratio 0.38 (95% CI 0.21–0.69)). More frequent resective surgical recurrences were reported from Copenhagen (hazard ratio 3.23 (95% CI 1.32–7.89)). Conclusions: A mild course of disease in terms of disease recurrence was observed in this European cohort. Phenotype at diagnosis had predictive value for disease recurrence with upper gastrointestinal disease being the most important positive predictor. A phenotypic North-South gradient in CD may be present, illustrated by higher surgery risks in some of the Northern European centres.

Health-related quality of life in patients with inflammatory bowel disease measured with the short form-36: Psychometric assessments and a comparison with general population norms

Background: We compared health‐related quality of life (HRQOL) in a population‐based cohort of Norwegian patients with inflammatory bowel disease (IBD) with a normal reference population by means of the short form‐36 (SF‐36) questionnaire, including the effect of age, sex, educational status, and symptom severity and the psychometric properties of the questionnaire. Methods: The SF‐36 was self‐administered and was answered by the patients at the hospital at 2 occasions that were 6 months apart. Results: Five hundred fourteen patients with IBD were eligible for analysis: 348 with ulcerative colitis (UC) and 166 with Crohns disease (CD). The comparison group consisted of 2323 Norwegian people. The dimension scores for SF‐36 were significantly lower in 6 of 8 dimensions for patients with UC and in 7 of 8 dimensions for patients with CD than for the reference population. In both patients with UC and patients with CD, we found lower scores in elderly patients, which also was found in the background population. Women scored lower than men in all dimension scores. In both patients with UC and patients with CD, there was a statistically significant reduction in HRQOL score with increasing symptoms. The SF‐36 has satisfactory reliability and discriminant ability for scores for all dimensions in both patients with UC and patients with CD. However, when measuring responsiveness, the figures were generally low. This finding, together with the high ceiling effects, may indicate that the SF‐36 has limitations regarding detecting deterioration or improvement over time. Conclusion: We have shown that HRQOL in a Norwegian population‐based cohort of patients with IBD, measured with the SF‐36, is lower than that of a Norwegian reference population. In general, the SF‐36 was found to have satisfactory psychometric properties in this IBD population.

Ulcerative Colitis: Patient Characteristics May Predict 10-Yr Disease Recurrence in a European-Wide Population-Based Cohort

OBJECTIVES:Cumulative 10-yr relapse rates in ulcerative colitis (UC) of 70% to almost 100% have been reported in regional studies. The aim of this study was to determine the relapse rate in UC in a European population-based cohort 10 yr after diagnosis and to identify factors that may influence the risk of relapse.METHODS:From 1991 to 1993, 771 patients with UC from seven European countries and Israel were prospectively included in a population-based inception cohort and followed for 10 yr. A relapse was defined as an increase in UC-related symptoms leading to changes in medical treatment or surgery. The cumulative relapse rate, time to first relapse, and number of relapses in the follow-up period were recorded and possible causative factors were investigated.RESULTS:The cumulative relapse rate of patients with at least one relapse was 0.67 (95% CI 0.63–0.71). The time to first relapse showed a greater hazard ratio (HR) (1.2, CI 1.0–1.5) for women and for patients with a high level of education (1.4, CI 1.1–1.8). The number of relapses decreased with age, and current smokers had a lower relapse rate (0.8, CI 0.6–0.9) than nonsmokers. The relapse rate in women was 1.2 (CI 1.1–1.3) times higher than in men. An inverse relation was found between the time to the first relapse and the total number of relapses.CONCLUSION:In 67% of patients, there was at least one relapse. Smoking status, level of education, and possibly female gender were found to influence the risk of relapse.

Relationship between sick leave, unemployment, disability, and health‐related quality of life in patients with inflammatory bowel disease

Background The goal of this study was to determine the rate of work disability, unemployment, and sick leave in an unselected inflammatory bowel disease (IBD) cohort and to measure the effect of working status and disability on the patients health‐related quality of life (HRQOL). Materials and Methods All eligible patients were clinically examined and interviewed at the 5‐year follow‐up visit. In addition, they completed the 2 HRQOL questionnaires, the Short Form‐36 Health Survey (SF‐36) and the Inflammatory Bowel Disease Questionnaire validated for use in Norway (N‐IBDQ). Data regarding sick leave, unemployment, and disability pension (DP) also were collected. Results All together, 495 patients were or had been in the workforce during the 5‐year follow‐up period since diagnosis. Forty‐two patients (8.5%) were on DP compared with 8.8% in the background population. Women with Crohns disease (CD) had the highest probability of receiving DP (24.6%). A total of 58 patients (11.7%) reported they were unemployed at 5 years. This was equally distributed between men and women but was more frequent in patients with ulcerative colitis. Sick leave for all causes was reported in 47% with ulcerative colitis and 53% with CD, whereas IBD‐related sick leave was reported in 18% and 23%, respectively. A majority (75%) had been sick <4 weeks, and a relatively small number of patients (25%) contributed to a large number of the total sick leave days. Both unemployment and DP reduced HRQOL scores, but the most pronounced effect on HRQOL was found in patients reporting IBD‐related sick leave, measured with SF‐36 and N‐IBDQ. The observed differences also were highly clinically significant. Multiple regression analysis confirmed that IBD‐related sick leave was the independent variable with the strongest association to the observed reduction in HRQOL scores. Conclusions Unemployment or sick leave is more common in IBD patients than in the Norwegian background population. The number of patients receiving DP is significantly increased in women with CD but not in the other patient groups. Unemployment, sick leave, and DP are related to the patients HRQOL in a negative way, but this effect is most pronounced in patients reporting IBD‐related sick leave.

Work disability in inflammatory bowel disease patients 10 years after disease onset: results from the IBSEN Study

Objective To compare the work disability (WD) rate in inflammatory bowel disease (IBD) patients 10 years after disease onset, with the WD rate in the background population,and to assess whether clinical or demographic factors in the early disease course could predict WD after 10 years disease. Design A large, population-based inception cohort (the Inflammatory Bowel in South Eastern Norway cohort) was prospectively followed up at 1, 5 and 10 years after diagnosis. At the 10-year follow-up data on WD were collected. Data on disability pension (DP) in the background population were retrieved from public databases. We calculated overall and age-standardised relative risks (RR) for DP. Logistic regression analysis was used to examine predictive factors. Results A total of 518 patients completed the 10-year follow-up (response rate 83.5%). The overall disability rate in the IBD population was 18.8%, and the RR was 1.8 (95% CI 1.4 to 2.3) for ulcerative colitis (UC) and 2.0 (95% CI 1.4 to 2.7) for Crohns disease (CD). The RR for DP was highest in patients aged below 40 years while patients aged over 60 years had no increased RR. Steroid treatment at the 1-year follow-up predicted WD after 10 years disease in both CD and UC. In UC, increased C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) at diagnosis, early colectomy, and more than two relapses during the first year of the disease also predicted WD. Conclusion Ten years after disease onset IBD patients had an increased RR for DP as compared with the background population. The youngest patients had the highest RR. Markers of severe disease course predicted WD.

Chronic fatigue is more prevalent in patients with inflammatory bowel disease than in healthy controls.

Background: Fatigue is a common symptom in chronic disease. Few studies, however, have focused on fatigue related to inflammatory bowel disease (IBD). The aim was to determine the prevalence of fatigue in IBD and to identify demographic and clinical factors that influence fatigue. Methods: Patients in remission and with mild and moderate IBD completed the Fatigue Questionnaire (FQ). Higher FQ scores indicate greater levels of fatigue. In addition, demographic and clinical variables were obtained. Corresponding FQ data from healthy controls (HC) are based on 2287 Norwegian citizens. Results: In total, 140 patients were included, mean age 43.9 years (SD 16.4), male/female = 61/79, ulcerative colitis (UC) / Crohns disease (CD) = 92/48. Total fatigue (TF) was 14.4, 14.7, and 12.2 for UC, CD, and HC, respectively. Chronic fatigue (CF), defined as substantial fatigue with duration more than 6 months, was reported in 29% (14/48) of CD and 22% (20/92) of UC compared to 11% (260/2287) of HC (P < 0.001 for both diagnoses). Linear regression analysis confirmed hemoglobin values, present gastrointestinal symptoms, and altered sleep to be the most important predictors of CF. Conclusions: Chronic fatigue is more common in patients with UC and CD compared with healthy controls. IBD symptoms, hemoglobin values, and altered sleep patterns are significant predictors of CF. (Inflamm Bowel Dis 2010)

The Role of Quality of Care in Health-related Quality of Life in Patients with IBD

In the literature there are indications of associations between health-related quality of life (HRQoL) in inflammatory bowel disease and disease activity, psychological status, coping, stressful life events, and social support. The aim of this study was to examine whether a relation exists between quality of health care and HRQoL, taking possible confounding variables into account.For this purpose, one single questionnaire was compiled from existing validated questionnaires. A population-based inception cohort of 1056 patients with inflammatory bowel disease in eight countries, diagnosed 6 to 8 years prior to the study, was approached to participate.In total, 824 patients responded (78%), and 517 could be included in statistical analyses. It was shown that in inflammatory bowel disease HRQoL was indeed influenced by quality of care (particularly with regard to the parameters of “providing information,” “costs,” and “courtesy”), as well as by disease activity, psychological status, type of hospital, social support, stressful life events, and way of administration of the questionnaire. Patients with active disease had lower psychological status and HRQoL scores at the time of the survey than patients without active disease. However, quality of care scores did not differ between these groups. The care aspect “costs” was scored worse by CD compared with UC patients, probably caused by a potentially more expensive treatment.In conclusion, it is shown in a large exploratory study, for the first time, that in inflammatory bowel disease, quality of care has a significant role in determining health-related quality of life.

Chronic fatigue is associated with impaired health‐related quality of life in inflammatory bowel disease

Aliment Pharmacol Ther 2011; 33: 106–114

Five-year outcome after gastric bypass for morbid obesity in a Norwegian cohort

BACKGROUND Few long-term reports with high rates of follow-up are available after gastric bypass. We report changes in weight, co-morbidity, cardiovascular risk, and health-related quality of life (HRQoL) 5 years after gastric bypass. METHODS Patients who had gastric bypass (2004-2006) were included. Prospective data were reviewed. Long-term complications, cardiovascular risk factors, and HRQoL were evaluated, and the 10-year risk for coronary heart disease was estimated (Framingham risk score). Outcomes were compared in patients with body mass index (BMI)<50 and ≥50 kg/m(2). RESULTS A total of 184 of 203 patients (91%) met to follow-up. The mean ± SD preoperative BMI was 46 ± 5 kg/m(2), and the mean ± SD age was 38 ± 9 years; 75% were women. Thirty-two percent of the patients had a BMI ≥50 kg/m(2), and 30% had type 2 diabetes. Follow-up was 63 ± 5 months. After 5 years, total weight loss was 27% ± 11%. Remission of type 2 diabetes had occurred in 67%. The prevalence of hypertension, dyslipidemia, sleep apnea, and metabolic syndrome had decreased. HRQoL was improved. The Framingham risk score was reduced (5.6% versus 4.6%; P = .021). Sixty-one patients (33%) had long-term complications, most commonly chronic abdominal pain (10%). BMI was 33 ± 5 and 37 ± 7 kg/m(2) in patients with preoperative BMI<50 and ≥50 kg/m(2), but changes in metabolic, cardiovascular risk profile and HRQoL were broadly similar. CONCLUSIONS Beneficial effects on weight loss, cardiovascular risk, and HRQoL were documented 5 years after gastric bypass in morbidly and super-obese patients.