Health-related quality of life improves during one year of medical and surgical treatment in a European population-based inception cohort of patients with inflammatory bowel disease--an ECCO-EpiCom study.

BACKGROUND & AIMS: Health-related quality of life (HRQoL) is impaired in patients with Inflammatory Bowel Disease (IBD). The aim was prospectively to assess and validate the pattern of HRQoL in an unselected, population-based inception cohort of IBD patients from Eastern and Western Europe. METHODS: The EpiCom inception cohort consists of 1560 IBD patients from 31 European centres covering a background population of approximately 10.1 million. Patients answered the disease specific Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and generic Short Form 12 (SF-12) questionnaire at diagnosis and after one year of follow-up. RESULTS: In total, 1079 patients were included in this study. Crohn's disease (CD) patients mean SIBDQ scores improved from 45.3 to 55.3 in Eastern Europe and from 44.9 to 53.6 in Western Europe. SIBDQ scores for ulcerative colitis (UC) patients improved from 44.9 to 57.4 and from 48.8 to 55.7, respectively. UC patients needing surgery or biologicals had lower SIBDQ scores before and after compared to the rest, while biological therapy improved SIBDQ scores in CD. CD and UC patients in both regions improved all SF-12 scores. Only Eastern European UC patients achieved SF-12 summary scores equal to or above the normal population. CONCLUSION: Medical and surgical treatment improved HRQoL during the first year of disease. The majority of IBD patients in both Eastern and Western Europe reported a positive perception of disease-specific but not generic HRQoL. Biological therapy improved HRQoL in CD patients, while UC patients in need of surgery or biological therapy experienced lower perceptions of HRQoL than the rest.

Health care and patients' education in a European inflammatory bowel disease inception cohort: an ECCO-EpiCom study.

BACKGROUND AND AIMS: The EpiCom study and inception cohort was initiated in 2010 in 31 centers from 14 Western and 8 Eastern European countries, covering a 10.1million person background population. Our aim was to investigate whether there is a difference between Eastern and Western Europe in health care and education of patients with inflammatory bowel disease (IBD). METHODS: A quality of care (QoC) questionnaire was developed in the EpiCom group consisting of 16 questions covering 5 items: time interval between the onset of symptoms and diagnosis, information, education, empathy and access to health care providers. RESULTS: Of 1,515 patients, 947 (217 east/730 west) answered the QoC questionnaire. Only 23% of all patients had knowledge about IBD before diagnosis. In Eastern Europe, significantly more patients searched out information about IBD themselves (77% vs. 68%, p<0.05), the main source was the Internet (92% vs. 88% p=0.23). In Western Europe, significantly more patients were educated by nurses (19% vs. 1%, p<0.05), while in Eastern Europe, gastroenterologists were easier to contact (80% vs. 68%, p<0.05). CONCLUSION: Health care differed significantly between Eastern and Western Europe in all items, but satisfaction rates were high in both geographic regions. Because of the low awareness and the rising incidence of IBD, general information should be the focus of patient organizations and medical societies. In Western Europe IBD nurses play a very important role in reducing the burden of patient management.

East-West gradient in the incidence of inflammatory bowel disease in Europe: the ECCO-EpiCom inception cohort.

OBJECTIVE: The incidence of inflammatory bowel disease (IBD) is increasing in Eastern Europe. The reasons for these changes remain unknown. The aim of this study was to investigate whether an East-West gradient in the incidence of IBD in Europe exists. DESIGN: A prospective, uniformly diagnosed, population based inception cohort of IBD patients in 31 centres from 14 Western and eight Eastern European countries covering a total background population of approximately 10.1 million people was created. One-third of the centres had previous experience with inception cohorts. Patients were entered into a low cost, web based epidemiological database, making participation possible regardless of socioeconomic status and prior experience. RESULTS: 1515 patients aged 15 years or older were included, of whom 535 (35%) were diagnosed with Crohn's disease (CD), 813 (54%) with ulcerative colitis (UC) and 167 (11%) with IBD unclassified (IBDU). The overall incidence rate ratios in all Western European centres were 1.9 (95% CI 1.5 to 2.4) for CD and 2.1 (95% CI 1.8 to 2.6) for UC compared with Eastern European centres. The median crude annual incidence rates per 100,000 in 2010 for CD were 6.5 (range 0-10.7) in Western European centres and 3.1 (range 0.4-11.5) in Eastern European centres, for UC 10.8 (range 2.9-31.5) and 4.1 (range 2.4-10.3), respectively, and for IBDU 1.9 (range 0-39.4) and 0 (range 0-1.2), respectively. In Western Europe, 92% of CD, 78% of UC and 74% of IBDU patients had a colonoscopy performed as the diagnostic procedure compared with 90%, 100% and 96%, respectively, in Eastern Europe. 8% of CD and 1% of UC patients in both regions underwent surgery within the first 3 months of the onset of disease. 7% of CD patients and 3% of UC patients from Western Europe received biological treatment as rescue therapy. Of all European CD patients, 20% received only 5-aminosalicylates as induction therapy. CONCLUSIONS: An East-West gradient in IBD incidence exists in Europe. Among this inception cohort--including indolent and aggressive cases--international guidelines for diagnosis and initial treatment are not being followed uniformly by physicians.

Environmental factors in a population-based inception cohort of inflammatory bowel disease patients in Europe--an ECCO-EpiCom study.

BACKGROUND AND AIMS: The incidence of inflammatory bowel disease (IBD) is increasing in Eastern Europe possibly due to changes in environmental factors towards a more "westernised" standard of living. The aim of this study was to investigate differences in exposure to environmental factors prior to diagnosis in Eastern and Western European IBD patients. METHODS: The EpiCom cohort is a population-based, prospective inception cohort of 1560 unselected IBD patients from 31 European countries covering a background population of 10.1 million. At the time of diagnosis patients were asked to complete an 87-item questionnaire concerning environmental factors. RESULTS: A total of 1182 patients (76%) answered the questionnaire, 444 (38%) had Crohn's disease (CD), 627 (53%) ulcerative colitis (UC), and 111 (9%) IBD unclassified. No geographic differences regarding smoking status, caffeine intake, use of oral contraceptives, or number of first-degree relatives with IBD were found. Sugar intake was higher in CD and UC patients from Eastern Europe than in Western Europe while fibre intake was lower (p<0.01). Daily consumption of fast food as well as appendectomy before the age of 20 was more frequent in Eastern European than in Western European UC patients (p<0.01). Eastern European CD and UC patients had received more vaccinations and experienced fewer childhood infections than Western European patients (p<0.01). CONCLUSIONS: In this European population-based inception cohort of unselected IBD patients, Eastern and Western European patients differed in environmental factors prior to diagnosis. Eastern European patients exhibited higher occurrences of suspected risk factors for IBD included in the Western lifestyle.

eHealth: individualisation of infliximab treatment and disease course via a self-managed web-based solution in Crohn's disease.

BACKGROUND: Infliximab (IFX) maintenance therapy for Crohn's disease (CD) is administered every 8 weeks, but inter-patient variation in optimal treatment intervals may exist. AIM: To assess, in a prospective pilot study, the efficacy, safety and quality of life (QoL) of IFX maintenance treatment scheduled through web-based self-monitoring of disease activity. METHODS: Twenty-seven CD patients in IFX maintenance therapy were enrolled and received a standardised disease education and web-training. Using the http://www.cd.constant-care.dk concept, patients recorded their disease activity and faecal calprotectin weekly. From this, the inflammatory burden (IB) score was calculated, placing patients in the green, yellow or red zones of a 'traffic light' system. If placed in the yellow or red zones, the computer directed these patients to consult their physician for IFX infusion. RESULTS: Seventeen patients (63%) completed 52 weeks of follow-up, 6 (22%) completed 26 weeks and 4 (15%) were excluded due to loss of response, patient decision or non-adherence. In total, 121 IFX infusions were given with a median interval of 9 (range: 4­18) weeks. Only 10% of infusions were given at 8-week intervals, whereas 39% were administered with shorter and 50% with longer intervals respectively. The mean IB and the QoL remained stable during the web-treatment. One mild infusion reaction and one case of folliculitis were observed, while three patients underwent surgery. CONCLUSIONS: The program http://www.cd.constant-care.dk appears to be a practical and safe concept for the individualised scheduling of maintenance treatment with IFX in patients with Crohn's disease. Larger studies are awaited to confirm this preliminary outcome.

Prognostic impact of different regional referral practices for interventional investigation and coronary treatment after exercise testing: a population-based 5-year follow-up study.

OBJECTIVE: To examine the association among different centres' referral practices for coronary angiography (CAG) after exercise testing, with 1- and 5-year outcomes. DESIGN: Observational population-based cohort study. SETTING: All 10 hospitals and six private practising consultants in Aarhus and Ringkjoebing counties (900 000 inhabitants), Denmark. SUBJECTS: All patients who in 1996 had an abnormal bicycle exercise test (n = 736). MEASUREMENTS: Referral for CAG, coronary intervention, cardiovascular and all-cause mortality, and myocardial infarction (MI). RESULTS: As an immediate consequence of the exercise test, 60.7% of subjects were referred for CAG. Based on the centres' fraction of patients referred for CAG, three categories of centres were defined: low (<33%), intermediate (33-66%) and high (>66%). A low compared with a high referral fraction was associated with a similar 5-year mortality and MI ratio [all-cause/cardiovascular mortality rate ratio (RR) = 1.33, 95% confidence interval (CI): 0.45-3.92/RR = 0.62, 95% CI: 0.25-1.57; and MI RR = 0.92, 95% CI: 0.45-1.86]. The same was found for an intermediate compared with a high fraction (all-cause/cardiovascular mortality RR = 0.92, 95% CI: 0.49-1.72/RR = 0.74, 95% CI: 0.42-1.33; and MI RR = 1.07, 95% CI: 0.68-1.70). Estimates were about the same after 1 year of follow-up with no major differences among centres in mortality or MI. CONCLUSIONS: Centres' different referral practices for interventional investigation and treatment were not associated significantly with short-term or long-term mortality or MI among patients with an abnormal exercise test.

Opioid treatment of painful chronic pancreatitis.

BACKGROUND: Abdominal pain is the dominant symptom in 50-75% of patients with chronic pancreatitis, often requiring opioid analgesics. Fentanyl, a potent synthetic opioid, can be administered percutaneously at a constant dose and is claimed to have fewer systemic side effects. AIM: To evaluate transdermal fentanyl plaster versus sustained release morphine tablets as analgesic treatment of painful chronic pancreatitis. METHODS: In an open randomized crossover trial, 18 patients were included. The treatment period was 4 wk for each drug. All patients had immediate-release morphine tablets as rescue medication. RESULTS: The dosage of transdermal fentanyl had to be increased on average 50% over that indicated by the manufacturer. When this was done and rescue medication was secured, no difference between the two drugs in primary endpoint or patient preference was observed. There was also no difference in the secondary endpoints, pain control, and quality of life. However, skin side effects, mostly mild, occurred in 44% of the patients during treatment with transdermal fentanyl, and the mean daily dose of immediate release morphine was significantly higher during the transdermal fentanyl period than during the sustained-release morphine period (30.7 mg vs. 14.7 mg [p < 0.01]). CONCLUSION: When given in an appropriate dose, transdermal fentanyl might be useful for treatment of some patients with painful chronic pancreatitis, e.g., when tablet ingestion is difficult. However, the dosage often has to be increased above that recommended by the manufacturer. The need of rescue morphine is considerable and skin side effects often occur. Transdermal fentanyl is, therefore, not the ideal first-choice analgesic in patients with painful chronic pancreatitis.

Regional variations in the use of diagnostic coronary angiography. A one-year population-based study of all diagnostic coronary angiographies performed in a rural and an urban Danish county.

The aim of this study was to monitor coronary angiography activity and results, and to evaluate indications and treatment consequences using regional hospital registers and case records in the rural county of Ringkjøbing and urban county of Aarhus The study included all patients who had undergone a coronary angiography during 1996. For women, there were 606 (rural) and 1296 (urban) coronary angiographies per one million inhabitants (p < 0.0001) and for men, 1884 (rural) and 3051 (urban) coronary angiographies per one million inhabitants (p < 0.0001). In both counties the age distribution of the women examined was the same as that for the men. The angiographic rates were the same in the two counties for patients examined for valvular heart disease and severe arrhythmias. For patients with ischaemic heart disease, the angiographic rate for rural patients was two to three times lower than that for urban patients (p < 0.01). Revascularization procedures were performed in 39% (rural) and 40% (urban) of the examined women (NS) and 66% (rural) and 59% (urban) of the examined men (p < 0.05). Despite wide regional differences in coronary angiography activity, angiography was deployed to the same extent for examination of patients with valvular and severe arrhythmia heart disease. For patients examined for ischaemic heart disease, angiography activity was considerably lower in the rural area. The female patients had a higher frequency of normal coronary angiograms than the male patients.

Helicobacter pylori infection in patients with chronic pancreatitis and duodenal ulcer.

BACKGROUND: The prevalence of duodenal ulcer is high in patients with chronic pancreatitis. Patients with simple duodenal ulcer without chronic pancreatitis are mostly Helicobacter pylori-infected, and the prevalence of IgG seropositivity is > 95%. The prevalence of H. pylori infection in patients with chronic pancreatitis is not known. METHODS: IgG antibodies against H. pylori were measured in a cross-sectional survey of consecutive patients who had their exocrine pancreas function examined with a Lundh meal test in the period 1988-95 and in a control group of patients with simple duodenal ulcer. RESULTS: Twenty-seven per cent of the patients with chronic pancreatitis had duodenal ulcer during the observation period. The prevalence of IgG antibodies against H. pylori was 22% in patients with chronic pancreatitis without duodenal ulcer as compared with 27% with non-organic abdominal pain. The prevalence of IgG antibodies against H. pylori was 60% in patients with chronic pancreatitis complicated by duodenal ulcer as compared with 86% in controls with simple duodenal ulcer. CONCLUSIONS: H. pylori infection contributes but may not be the only cause of duodenal ulcer in patients with chronic pancreatitis.

Technetium-99m hexamethylpropylene amine oxime leucocyte scintigraphy in the early course of mild acute pancreatitis following endoscopic retrograde cholangiopancreatography.

We evaluated the diagnostic accuracy of technetium-99m hexamethylpropylene amine oxime (HMPAO) leucocyte scintigraphy in mild acute pancreatitis. A study design was chosen that gave us an opportunity to assess patients by leucocyte scintigraphy in the very early course of the disease. Thirty-two consecutive patients referred for endoscopic retrograde cholangiopancreatography were followed according to a very rigid protocol with laboratory tests and clinical examination before and after the endoscopic procedure and leucocyte scintigraphy [including single-photon emission tomography (SPET)] performed within 24 h. Planar and SPET images were examined by two observers who were blinded to each other and to the clinical history and diagnosis. Eight (25%) of the 32 patients developed mild acute pancreatitis, and only one of these patients had a positive scan. Sensitivity, specificity and accuracy of 13%, 79% and 63%, respectively, were achieved when both planar and SPET images were considered. When only planar images were considered the sensitivity, specificity and accuracy were 13%, 96% and 75%, respectively. No evidence of pathological leucocyte accumulation in mild acute pancreatitis was found despite the aforementioned very rigid protocol, allowing patients to be assessed by 99mTc-HMPAO leucocyte scintigraphy in the very early phase of the disease (this was true even when using SPET). From a clinical point of view, we believe that leucocyte scintigraphy should be used only when the disease is moderate or severe and serious intra-abdominal complications are suspected.