ObjectiveThis study aimed to develop and validate a patient-reported outcome measure (PROM) in acute pancreatitis (AP) as an endpoint centred on the patient.DesignA PROM instrument (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis, an international proSpEctive cohort study, PAN-PROMISE scale) was designed based on the opinion of patients, professionals and an expert panel. The scale was validated in an international multicentre prospective cohort study, describing the severity of AP and quality of life at 15 days after discharge as the main variables for validation. The COSMIN (COnsensus-based Standards for the selection of health status Measurement INstruments) methodology was applied. Both the design and validation stages considered the content and face validity of this new instrument; the metric properties of the different items, reliability (reproducibility and internal consistence), the construct, structural and criterion validity, responsiveness and interpretability of this scale.ResultsPAN-PROMISE consists of a seven-item scale based on the symptoms that cause the most discomfort and concern to patients with AP. The validation cohort involved 15 countries, 524 patients. The intensity of symptoms changed from higher values during the first 24 hours to lower values at discharge and 15 days thereafter. Items converged into a unidimensional ordinal scale with good fit indices. Internal consistency and split-half reliability at discharge were adequate. Reproducibility was confirmed using test–retest reliability and comparing the PAN-PROMISE score at discharge and 15 days after discharge. Evidence is also provided for the convergent-discriminant and empirical validity of the scale.ConclusionThe PAN-PROMISE scale is a useful tool to be used as an endpoint in clinical trials, and to quantify patient well-being during the hospital admission and follow-up.Trial registration numberNCT03650062

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Background: The differential diagnosis between mucinous(M) and non-mucinous (NM) pancreatic cystic lesions (PCLs) is often difficult and both false positive and negative results can lead to clinically relevant overtreatment and undertreatment. Dosage of intracystic Carcinoembryonic antigen (CEA) with a cut-off>192 ng/ml suggests the diagnosis of M-PCL, but its sensitivity is limited. Recently, it has been reported that low levels of intracystic glucose diagnose M-PCLs with high accuracy, but data are limited and heterogeneous. Objective: We aimed to perform a metaanalysis to gather data on sensitivity, specificity and accuracy of intracystic glucose as compared with CEA for the diagnosis of M-PCLs. Methods: A computerized bibliographic search was performed on Pubmed. Pooled effects were calculated using a random-effects model and expressed in terms of pooled sensitivity and specificity and OR (95% CI) for accuracy for the diagnosis of M-PCLs. Heterogeneity was evaluated by I 2 and publication bias by Begg-Mazumdar test and funnel plot visual inspection. Results: Overall, 4 cohort studies were included (3 conducted in the US, 1 in Portugal), for a total of 319 patients (207 M, 112 NM). The cut-off employed for glucose were 50 in 3 studies and 66 mg/dl in one, while all studies employed the CEA cut-off of 192 ng/ml. The employed gold-standard for diagnosis in the 4 studies was a composite of surgical pathology and cytology. Dosage of glucose showed a higher pooled sensitivity and lower heterogeneity (92%; I 2 Z 0%) compared to CEA (69.4%; I 2 Z64%), while specificity was higher for CEA (75.6% glucose vs 92% CEA) with lower heterogeneity (I 2 Z89% glucose vs 69% CEA). Dosage of glucose was very close to be significantly superior in terms of pooled accuracy (OR 1.96; 95% CI 0.97-3.94; pZ0.057; I 2 Z53%). There was no publication bias at Begg-Mazumdar test and funnel plot. Conclusion: Our meta-analysis suggests that intracystic dosage of glucose is more sensitive, but CEA more specific for the diagnosis of mucinous PCLs, with an overall better accuracy of glucose. Given the heterogeneity of the results and the relative low number of investigated patients considering the high prevalence of PCLs, more studies are needed to define if combined use of both markers with different cut-offs is needed to increase accuracy significantly.

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Background Background: The feasibility of anti-TNF discontinuation in inflammatory bowel disease (IBD) must be proven in clinical trials including patients in clinical, endoscopic, and radiologic remission at the time of anti-TNF withdrawal to make recommendations for clinical practice. Aims Primary: to compare the rates of clinical remission at 1 year in patients who discontinue anti-TNF treatment vs. those who continue treatment. Secondary objectives: to know the effect of anti-TNF withdrawal on relapse-free time, mucosal healing and safety; and to identify predictive factors for relapse. Methods Prospective, quadruple-blind, multicentre, randomised, controlled trial. Patients with ulcerative colitis (UC) or Crohn’s disease (CD) in clinical remission for > 6 months were randomised to maintain anti-TNF treatment [maintenance arm (MA)] or to withdraw it [withdrawal arm (WA)]. Patients who were on infliximab (IFX) received IFX 5 mg/kg or an intravenous placebo every 8 weeks, while patients on adalimumab (ADA) received subcutaneous ADA 40 mg or placebo every other week. Patients were followed-up until month 12 or up to the time of clinical relapse, whichever came first. Inclusion and exclusion criteria, trial scheme and definitions are summarized in figures 1a, 1b and 1c. Results were analysed by intention-to-treat (ITT) and by per-protocol (PP). Local investigators were blinded to faecal calprotectin (FC) and IFX and ADA trough levels. On-site monitoring was performed to assess data quality. Results 159 patients were screened, from whom 140 were randomised and comprised the ITT cohort: 70 allocated to the MA and 70 to the WA. Fifteen patients dropped out before the end of follow-up (12 months or relapse), leaving 63 patients in the MA and 62 patients in the WA for the PP analysis. The characteristics of patients in the MA and WA were similar (figure 2). The proportions of patients who maintained clinical remission -59/70 (84%), 95% confidence interval (CI)=74-92% in the MA vs. 53/70 (76%), 95%CI=64-85% in the WA- and who remained without significant endoscopic lesions at the end of follow-up were similar between groups (figures 3a, 3b, 3c). Only the proportion of patients with FC >250 mg/g was higher in the WA at the end of follow-up (figure 3d). Maintenance of clinical remission was no different between groups (figure 4). The same percentage of patients in both groups had at least one adverse event (69%). The proportion of patients with serious adverse events was also similar between groups (4% in MA vs. 7% in WA). Conclusion Anti-TNF withdrawal in selected IBD patients in clinical, endoscopic, and radiologic remission could be feasible without an increase in the risk of clinical relapse. Long-term follow-up of these patients is warranted.