Consecutive fecal calprotectin measurements to predict relapse in patients with ulcerative colitis receiving infliximab maintenance therapy.

BACKGROUND: This study examined whether fecal calprotectin can be used in daily practice as a marker to monitor patients with ulcerative colitis (UC) receiving infliximab maintenance therapy. METHODS: This prospective multicenter study enrolled adult patients with UC in clinical remission under infliximab maintenance therapy. Fecal calprotectin levels were measured every 4 weeks. Sigmoidoscopies were performed at inclusion and at study end. Relapse was defined as a clinical need for change in treatment or an endoscopic Mayo subscore of ≥2 at week 52. Sustained deep remission was defined as a partial Mayo score <3 at all points and an endoscopic Mayo score 0 at week 52. RESULTS: Full analysis was possible for 87 of 113 included patients with UC (77%). Of these patients, 30 (34.4%) were considered to be in sustained deep remission and 13 (14.9%) to have relapsed. Calprotectin levels in patients with sustained deep remission remained very low (median < 40 mg/kg at all time points). Patients who flared had significantly higher calprotectin levels (median > 300 mg/kg) already 3 months before the flare. Further receiver operator curve analysis suggested that a calprotectin level >300 mg/kg had a reasonable sensitivity (58.3%) and specificity (93.3%) to model flare. Two consecutive calprotectin measurements of >300 mg/kg with 1-month interval were identified as the best predictor of flare (61.5% sensitivity and 100% specificity). CONCLUSIONS: Fecal calprotectin can be used in daily practice to monitor patients with UC receiving infliximab maintenance therapy. Two consecutive measurements >300 mg/kg is more specific than a single measurement for predicting relapse.

Sustaining the vitality of colonoscopy quality improvement programmes over time. Experience from the Norwegian Gastronet programme.

OBJECTIVE: An important challenge of any quality assurance (QA) programme is to maintain interest among participants to ensure high data quality over time. The primary aim of this study was to identify factors associated with endoscopist compliance with the Norwegian QA programme for colonoscopies (Gastronet). MATERIAL AND METHODS: The Gastronet registration tools are an endoscopy report form to be filled in directly after the procedure by the endoscopist, and a satisfaction questionnaire to be filled in by the patient on the day after the examination. During the study period from 1 January 2004 to 31 December 2006, endoscopist compliance was measured by assessing patient report coverage, defined as the percentage of patient satisfaction questionnaires received by the Gastronet secretariat divided by the total number of colonoscopy reports registered by the individual endoscopists during the study period. Multivariate logistic regression models were applied to identify individual factors related to patient report coverage. RESULTS: Eighty-eight endoscopists from 10 hospitals contributed a total of 16,149 colonoscopies. Overall patient report coverage decreased from 87% in 2004 to 80% in 2006. A low patient report coverage was associated with time since the registrations started [odds ratio (OR) 0.98, 95% confidence interval (CI) 0.97-0.98; P < 0.001], use of sedation (OR 0.7, 95% CI 0.61-0.76; P < 0.001), and incomplete colonoscopy (OR 0.6, 95% CI 0.54-0.76; P < 0.001). CONCLUSIONS: Decreasing compliance with registration over time may compromise data quality and the validity of the results. Lower coverage of patient's reports (presumably for the most difficult examinations) may lead to erroneous conclusions regarding colonoscopy performance.

The Norwegian Gastronet project: Continuous quality improvement of colonoscopy in 14 Norwegian centres.

OBJECTIVE: The burden on colonoscopy capacity is considerable and expected to increase further as colorectal cancer screening programmes gain a foothold in Europe. In this situation, it is particularly important to evaluate the quality of the service given. In this article we present our first year of experience with a quality network of endoscopy centres in Norway (Gastronet). MATERIAL AND METHODS: A questionnaire focusing on caecal intubation rate and pain was completed by the endoscopist (on site) and patient (on the day after the examination). Fourteen centres participated with registration of 7370 colonoscopies by 73 endoscopists. RESULTS: There was 100% endoscopist participation, 87% coverage of colonoscopies and an estimated 76% questionnaire coverage of the patient population. Overall caecal intubation rate was 91%, range 83% to 97% between centres (p < 0.001). Patients reporting severe pain during colonoscopy differed from 2 to 24% between centres (p < 0.001). Variations could only partly be explained by differences in procedure practice (sedation, CO2 insufflation). For individual endoscopists, improvement after feedback on performance was restricted to the group of endoscopists having contributed with only 50-99 registered colonoscopies. CONCLUSIONS: In quality assurance programmes we recommend a limited number of variables for registration in order to secure high compliance by endoscopists and patients. One year of experience with Gastronet disclosed a satisfactory overall caecal intubation rate, but considerable variation between centres in practice and ability to offer painless colonoscopy. This suggests a need for formal, centralized training of colonoscopists or the development of quality standards for colonoscopy training and practice.