How variable is the mayo score between obnservers and might this affect trial recruitment or outcome

2009 
s of the 4th Congress of ECCO the European Crohn’s and Colitis Organisation S71 procedure to 95 minutes. A dedicated infusion unit for IBD patients can achieve high standards of care. P151 How variable is the Mayo score between observers and might this affect trial recruitment or outcome? A.J. Walsh1 *, A.O.S. Brain1, S. Keshav1, O. Buchel1, B. Merrin1, M. Rolinski1, S. Thomas1, W. Lydia1, D. Altman2, S. Travis1. 1The John Radcliffe Hospital, Oxford, United Kingdom, 2University of Oxford, Oxford, United Kingdom Background: The Mayo score for ulcerative colitis (UC) activity has 4 components: stool frequency (SF), rectal bleeding (RB), flexible sigmoidoscopy (FS) and physician’s global assessment (PGA). Each category scores 0 3. How interobserver variation (IOV) affects the Mayo score and its impact on criteria for inclusion or outcome of clinical trials are unknown. Methods: 100 patients with UC were seen independently, each on the same day, in random order, by 4 gastroenterologists. Both patient and clinicians completed proformas. A separate clinician performed video-recorded FS on the same day. The video was scored by the 4 gastroenterologists, blinded to other results. Comparison was made with inclusion criteria for ACT 1&2 trials (Mayo 6 12, endoscopy subscore 2), remission outcome (Mayo 2, no subscore >1) and partial Mayo score (endoscopy excluded). For clinical relevance (CR), scores were categorised as remission ( 2), mild (3 5), moderate (6 8), or severe (9 12) and an experienced, blinded clinician independently assigned an appropriate clinical category (ACC) to each patient by assessing symptoms, examination, blood results, FS and histology. Quadratic weighted u statistics assessed agreement within the Mayo score, where disagreements are weighted in relation to their magnitude. Results: Of 100 patients, there was complete agreement between 4 clinicians in total Mayo score in 6/96 (4 had no FS), varying by 2 points in 84/96, which changed clinical category in 23/84. Agreement for CR and ACC were good (u=0.88, u=0.81). Between patients and clinicians there was 70% agreement for SF and RB, but patients disagreed with individual clinicians in 30% for SF and 17% for RB. Patients scored a higher category than clinician in 34% for SF and 60% for RB. Between clinicians there was complete agreement in 65% for SF, 74% for RB, but only 21% for FS and 45% for PGA. Most disagreement was by one category (median 81%, range 74 93). For inclusion criteria, at least 1 clinician would have included 41/96, but all agreed in only 17/41 (41%). At least 2 clinicians would have included 22 and excluded 67, so there was at least 25% disagreement in 26/96 (27%) and 50% disagreement in 11/96 (11%). 11% had FS score 2 but total score 5; 9.1% had a total score 6 but a FS score 1. For remission, at least 1 clinician scored 2 in 43/96, but all agreed in only 20/43 (47%) and 2 agreed in 35/43 (81%). Agreement was not significantly improved by a total score 1. Conclusion: There is high variability in Mayo scoring between observers, despite good agreement on clinical category. Complete agreement between observers for recruitment to clinical trials or outcome occurs in <50% and 2 agreement in about 80% patients. IOV should be considered when calculating the power of clinical trials. P152 Double balloon enteroscopy: advancing the management of Crohn’s disease small bowel strictures E.J. Despott *, E. Tripoli, A. Polecina, K. Konieczko, C. Fraser. St Mark’s Hospital, Imperial College, London, United Kingdom Introduction: Despite the use of appropriate medical therapy, Crohn’s disease (CD) small bowel (SB) strictures remain a major cause of morbidity. CD SB strictures affect over a third of CD patients and often lead to the need for surgical management. Further to the intrinsic risks associated with surgery, affected patients also face the potential consequence of short bowel syndrome. Aims and Methods: Since introduction of DBE to our unit in 2005, data on cases of DBE CD SB stricture dilatation were prospectively collected for outcome, need for repeat dilatation and surgery. The DBEs were performed using the EN-450T5 scope (Fujinon, Saitama, Japan). Balloon dilatation was performed using controlled radial expansion (CRE) balloon dilators (Boston Scientific, Mass, USA). A standardised 10 cm visual analogue scale (VAS) characterised symptoms and dietary restriction before DBE stricture dilatation and at follow-up. Results: A total of 13 DBEs were done in 11 consecutive cases (mean age 46.4±7.8 years). In all but 1 case, the strictures were characterised radiologically before DBE. Eighteen SB stricture dilatations were performed in 9 of 11 patients. In 1 case, a retained video capsule was retrieved after dilatation of the culprit strictures. Mean stricture dilatation diameter was 14.5mm (range 12 20mm). In the 2 cases where stricture dilatation was not performed, DBE hindrance by adhesions made reaching the strictures impossible. These two cases were consequently managed surgically. One case of complex CD stricture dilatation was complicated by a delayed perforation. This case required a temporary jejunostomy which has since been reversed. In the other 8 cases SB stricture dilatation by DBE was an uncomplicated success; the symptom and dietary restriction scores improved dramatically and to date (mean follow up 19.4; range 1 40 months) none of these cases has required surgery for SB strictures. During follow-up, 2 patients required a repeat straightforward DBE dilatation (at 6.5 and 13 months respectively) due to recurrence of some of their symptoms. Although the numbers in this series are small, the clinical improvements in pre and post DBE VAS scores were large enough (means of 9.2 vs 1.7 respectively; p < 0.001). Conclusion: This case series adds to the small but growing body of published evidence that in selected patients with CD SB strictures, DBE facilitated stricture dilatation can prove to be very effective. This novel approach deserves further assessment in larger studies with more prolonged follow-up as the impact of on patient quality of life, avoidance of surgery associated risks and small bowel saving potential could be considerable. P153 The treatment of patients with antibiotic resistant pouchitis using stool coliform sensitivity testing S.D. McLaughlin1 *, S.K. Clark1, L. Petrovska2, S. Shafi1, P.P. Tekkis3, P.J. Ciclitira2, R. Nicholls3. 1St. Mark’s Hospital, London, United Kingdom, 2King’s College, London, United Kingdom, 3Imperial College, London, United Kingdom Background: Empirical antibiotic therapy remains the mainstay of treatment for pouchitis. Combination regimes of ciprofloxacin (C) and metronidaxole (M) can be effective for patients resistant to a single antibiotic agent but failure to enter remission and relapse on withdrawal or during maintenance treatment can occur. Faecal coliform antibiotic sensitivity testing was used to select optimal treatment for pouchitis resistant to standard therapy. Method: Faecal samples from patients with active pouchitis (pouch disease activity index (PDAI) 7) who failed standard antibiotic treatment were inoculated onto Iso-sensitest agar (Oxoid) using a sterile swab and rotary spreader. Antibiotic discs containing ciprofloxacin, trimethoprim, cefalexin, coamoxiclav, nitrofurantoin, cefpodoxime, cefuroxime, and cefixime were added. The plates were incubated at 37oC for 18 24 hours and the sensitivity patterns recorded. Following 4 weeks treatment with an antibiotic selected on its sensitivity, the clinical component of the PDAI was remeasured. by gest on A uust 8, 2016 http://eccoxfordjournals.org/ D ow nladed from
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