PICaSSO virtual electronic chromendoscopy accurately reflects combined endoscopic and histological assessment for prediction of clinical outcomes in ulcerative colitis.

BACKGROUND AND AIMS: A composite endoscopic-histologic remission is increasingly explored as an important endpoint in ulcerative colitis (UC). We investigated combined endoscopic-histologic remission for predicting clinical outcomes at 12 months compared with endoscopic remission alone using the high definition virtual chromoendoscopy (VCE) Paddington International virtual ChromoendoScopy ScOre (PICaSSO) and histology scores. METHODS: Ulcerative colitis patients, prospectively enrolled from 11 international centres, underwent VCE with targeted biopsies and followed up for 12 months. Endoscopic activity was assessed by Mayo Endoscopic Score (MES), Ulcerative Colitis Endoscopic Index Severity (UCEIS) followed by VCE-PICaSSO. Robarts Histopathological Index|Robarts Histological index≤3 without neutrophils in mucosa, and Nancy Histological index (NHI)≤ 1 were used to define histologic remission. Combined endoscopic-histologic remission was compared with endoscopic remission alone by Cox proportional hazards model and by two- and three-proportion analysis using pre-specified clinical outcomes. RESULTS: 307 patients were recruited and 302 analysed. There was no difference in survival without specified clinical outcomes between PICaSSO defined endoscopic remission alone and endoscopic plus histologic remission in the rectum (HR 0.42, 95%CI 0.16-1.11 and HR 1.03, 95%CI 0.42-2.52 for Robarts Histological index and NHI respectively) at 12 months. There was however a significant survival advantage without specified clinical outcome events for UCEIS combined with histology compared with UCEIS alone (HR 0.30, 95%CI 0.12-0.75, p = 0.02) at 12 months (but not combined with NHI). For MES there was no advantage for predicting specified clinical outcomes at 12 months for endoscopy alone versus endoscopy plus histology, but there were differences in two and three proportion analysis at 6 months. CONCLUSION: Endoscopic remission by VCE-PICaSSO alone was similar to combined endoscopic and histologic remission for predicting specified clinical outcomes at 12 months. Larger studies with specific therapeutic interventions are required to further confirm the findings.

Endoscopic full-thickness resection and its treatment alternatives in difficult-to-treat lesions of the lower gastrointestinal tract: a cost-effectiveness analysis.

OBJECTIVE: Endoscopic full-thickness resection (EFTR) has shown efficacy and safety in the colorectum. The aim of this analysis was to investigate whether EFTR is cost-effective in comparison with surgical and endoscopic treatment alternatives. DESIGN: Real data from the study cohort of the prospective, single-arm WALL RESECT study were used. A simulated comparison arm was created based on a survey that included suggested treatment alternatives to EFTR of the respective lesions. Treatment costs and reimbursement were calculated in euro according to the coding rules of 2017 and 2019 (EFTR). R0 resection rate was used as a measure of effectiveness. To assess cost-effectiveness, the average cost-effectiveness ratio (ACER) and the incremental cost-effectiveness ratio (ICER) were determined. Calculations were made both from the perspective of the care provider as well as of the payer. RESULTS: The cost per case was €2852.20 for the EFTR group, €1712 for the standard endoscopic resection (SER) group, €8895 for the surgical resection group and €5828 for the pooled alternative treatment to EFTR. From the perspective of the care provider, the ACER (mean cost per R0 resection) was €3708.98 for EFTR, €3115.10 for SER, €8924.05 for surgical treatment and €7169.30 for all pooled and weighted alternatives to EFTR. The ICER (additional cost per R0 resection compared with EFTR) was €5196.47 for SER, €26 533.13 for surgical resection and €67 768.62 for the pooled rate of alternatives. Results from the perspective of the payer were similar. CONCLUSION: EFTR is cost-effective in comparison with surgical and endoscopic treatment alternatives in the colorectum.

Cost analysis of a wait-and-see strategy after radiochemotherapy in distal rectal cancer.

BACKGROUND: Nonoperative management (NOM) of rectal cancer after radiochemotherapy (RtChx) in patients with a clinical complete response is an emerging strategy with the goal to improve quality of life without compromising cure rates. However close monitoring with both magnetic resonance imaging (MRI) and rectoscopy is required for the early detection of possible local regrowths. We therefore performed a cost analysis comparing the costs of immediate surgery with the costs for MRI and rectoscopy during surveillance as in the upcoming CAO/ARO/AIO-16 trial. METHODS: MRIs and rectoscopies of patients with a clinical complete response after RtChx over the course of 5 years were simulated and compared with immediate surgery after RtChx. Transition probabilities between health stages (no evidence of disease, local regrowth and salvage surgery, distant failure) were derived from the literature. Costs for ambulatory imaging and endoscopic studies were calculated according to the "Gebührenordnung für Ärzte" (GOÄ), costs for surgery based on the diagnosis-related groups system. Three different scenarios with higher costs for salvage surgery or higher regrowth rates were simulated. RESULTS: A patient without disease recurrence will generate costs for MRI and rectoscopy of 6344 € over 5 years compared with costs of 14,511 € for immediate radical surgery. When 25% local regrowths with subsequent salvage surgery were included in the model, the average costs per patient are 8299 €. In our simulations a NOM strategy was cost-saving compared with immediate surgery in all three scenarios. CONCLUSION: A NOM strategy with an intensive surveillance using MRI and rectoscopy will produce costs that are expected to remain below those of immediate surgery.

High Demand for Psychotherapy in Patients with Inflammatory Bowel Disease.

BACKGROUND: The relative contribution of psychological factors to the onset and course of inflammatory bowel diseases (IBD) is a matter of constant debate since its beginning, as is the clinical need and the efficacy of psychotherapeutic interventions. However, the perspective of patients with IBD has largely been ignored in this debate. METHODS: Psychometric tests including the Short-Form IBD Questionnaire (SIBDQ), the ADAP test measuring demand for psychotherapy, and the Fear-of-Progression Questionnaire Short Form as well as disease-related questions were positioned on the internet between December 2014 and January 2016. The study was advertised through DCCV (German branch of the European Federation of Crohn's and Ulcerative Colitis Associations). RESULTS: n = 631 patients responded, and complete data from n = 578 (356 Crohn's disease, 219 ulcerative colitis, 3 unclear) were available for analysis. n = 296 had previous experiences with psychotherapy, whereas n = 282 had not. This distribution clearly determined the factor "demand for psychotherapy" (chi-square = 23.7, P < 0.001). When all available data were entered into a (stepwise-forward) regression model, psychotherapy demand was dependent on previous experience (P < 0.001), fear of progression (P < 0.001), quality of life (P = 0.001), smoking (P = 0.003), and previous surgery (P = 0.005) with the total model explaining 29.7% of the variance. The total explained variance of this model was higher in ulcerative colitis (37.6%) than in Crohn's disease alone (25.4%). CONCLUSIONS: The demand for psychotherapy as additional therapy in IBD depends on previous experience with psychotherapy, fear for disease progression but also other disease or social characteristics and quality of life.