Helicobacter pylori: High dose amoxicillin does not improve primary or secondary eradication rates in an Irish cohort.

BACKGROUND: Helicobacter pylori (H. pylori) eradication rates have fallen globally, likely in large part due to increasing antibiotic resistance to traditional therapy. In areas of high clarithromycin and metronidazole resistance such as ours, Maastricht VI guidelines suggest high dose amoxicillin dual therapy (HDADT) can be considered, subject to evidence for local efficacy. In this study we assess efficacy of HDADT therapy for H. pylori eradication in an Irish cohort. AIM: To assess the efficacy of HDADT therapy for H. pylori eradication in an Irish cohort as both first line, and subsequent therapy for patients diagnosed with H. pylori. METHODS: All patients testing positive for H. pylori in a tertiary centre were treated prospectively with HDADT (amoxicillin 1 g tid and esomeprazole 40 mg bid × 14 d) over a period of 8 months. Eradication was confirmed with Urea Breath Test at least 4 wk after cessation of therapy. A delta-over-baseline > 4% was considered positive. Patient demographics and treatment outcomes were recorded, analysed and controlled for basic demographics and prior H. pylori treatment. RESULTS: One hundred and ninety-eight patients were identified with H. pylori infection, 10 patients were excluded due to penicillin allergy and 38 patients refused follow up testing. In all 139 were included in the analysis, 55% (n = 76) were female, mean age was 46.6 years. Overall, 93 (67%) of patients were treatment-naïve and 46 (33%) had received at least one previous course of treatment. The groups were statistically similar. Self-reported compliance with HDADT was 97%, mild side-effects occurred in 7%. There were no serious adverse drug reactions. Overall the eradication rate for our cohort was 56% (78/139). Eradication rates were worse for those with previous treatment [43% (20/46) vs 62% (58/93), P = 0.0458, odds ratio = 2.15]. Age and Gender had no effect on eradication status. CONCLUSION: Overall eradication rates with HDADT were disappointing. Despite being a simple and possibly better tolerated regime, these results do not support its routine use in a high dual resistance country. Further investigation of other regimens to achieve the > 90% eradication target is needed.

High diagnostic yield despite a lower completion rates for inpatient versus outpatient colon and pan-intestinal capsule endoscopy: a nested case-control study.

BACKGROUND: Increased familiarity with capsule endoscopy (CE) has been associated with a growing demand for urgent inpatient procedures. Limited data exists comparing the effect of admission status on colon capsule (CCE) and pan-intestinal capsule (PIC) performance. We aimed to compare the quality of inpatient versus outpatient CCE and PIC studies. METHODS: A retrospective nested case-control study. Patients were identified from a CE database. PillCam Colon 2 Capsules with standard bowel preparation and booster regimen were used in all studies. Basic demographics and key outcome measures were documented from procedure reports and hospital patient records, and compared between groups. RESULTS: 105 subjects were included, 35 cases and 70 controls. Cases were older, were more frequently referred with active bleeding and had more PICs. The diagnostic yield was high at 77% and was similar in both groups. Completion rates were significantly better for outpatients, 43% (n = 15) v's 71% (n = 50), OR 3, NN3. Neither gender nor age affected completion rates. Completion rates and preparation quality were similar for CCE and PIC inpatient procedures. CONCLUSION: Inpatient CCE and PIC have a clinical role. There is an increased risk of incomplete transit in inpatients, and strategies to mitigate against this are needed.

Colon capsule endoscopy is a viable alternative to colonoscopy for the investigation of intermediate- and low-risk patients with gastrointestinal symptoms: results of a pilot study.

Background and study aims Colon capsule endoscopy (CCE) is a recommended viable alternative to colonoscopy for colonic visualisation in a variety of clinical settings with proven efficacy in polyp detection, surveillance, screening and Inflammatory Bowel Disease (IBD) assessment. CCE efficacy in an unselected average risk symptomatic cohort has yet to be established. The aim of this study was to determine the feasibility of CCE imaging assessment in average risk symptomatic patients as an alternative to colonoscopy with and without additional biomarker assessment. Patients and methods This was a prospective, single-center comparison study of colonoscopy, CCE and biomarker assessment. Results Of 77 invited subjects, 66 underwent both a CCE and colonoscopy. A fecal immunochemical test (FIT) and fecal calprotectin (FC) were available in 56 and 59 subjects. In all 64 % (n = 42) had any positive finding with 16 (24 %) found to have significant disease (high-risk adenomas, IBD) on colonoscopy. The CCE completion rate was 76 %, five (8 %) had an inadequate preparation, the CCE polyp detection rate was high at 35 %. The sensitivity, specificity, positive and negative predictive values of CCE for significant disease were 81 %, 98 %, 93 % and 94 % respectively. In addition, three (5 %) significant small bowel diagnoses were made on CCE. FC and FIT were frequently elevated in patients with both colitis (5/7, 71 %) and high-risk adenomas (4/7 57 %). While both had a low positive predictive value for clinically significant disease, FIT 32 % and FC 26 %. Conclusions CCE is a safe and effective alternative to colonoscopy in symptomatic average risk patients with or without the addition of biomarker screening.

A novel value-based scoring system for endoscopic ultrasound-guided drainage of pancreatic fluid collections: a single-centre comparative study of plastic and lumen-apposing metal stents (NOVA study).

OBJECTIVE: Healthcare resources are finite. Value in healthcare can be defined as patient health outcomes achieved per monetary unit spent. Attempts have been made to quantify the value of luminal endoscopy, but there is little in the medical literature describing the value of the complex therapeutic endoscopic activity. This study aimed to characterise the value of endoscopic ultrasound (EUS)-guided drainage of pancreatic fluid collections (PFCs) with either plastic or lumen-apposing metal stents (LAMSs). METHODS: This is a single-centre, retrospective-prospective comparative study of 39 patients, who underwent EUS-guided PFC drainage between 2009 and 2018. Procedure value was calculated using the formula Q/(T/C), where Q is the quality of procedure adjusted for complications, T procedure duration and C is the complexity adjustment. Quality and complexity were estimated on a 1-4 Likert scale based on the American Society for Gastrointestinal Endoscopy criteria. Time (in minutes) was recorded from the patient entering and leaving the procedure room. Endoscopy time calculated from procedure time was considered a surrogate marker of cost as individual components of procedure cost were not itemized. RESULTS: Of 39 identified patients who underwent EUS-guided PFC drainage, 11 received double pigtail plastic stents (DPPSs) and 28 received LAMSs. The two groups were comparable in age, gender and aetiology. Nearly 40% of the LAMS interventions were considered high value but only 11% of the plastic stent interventions achieved the same. The difference predominantly was due to a higher rate of complications and longer procedure time. CONCLUSION: In this single-centre study, EUS-guided PFC drainage using LAMS was found to be a higher value procedure compared to the use of DPPS.

Development of significant disease in a cohort of patients with non-specific enteritis on capsule endoscopy: clinical suspicion and a high base line Lewis score are predictive of Crohn's disease.

BACKGROUND: As with isolated ileitis the findings of nonspecific small bowel enteritis (NSE) on capsule endoscopy (CE) poses a clinical challenge. There is lack of available evidence to help clinicians to predict significant disease and long-term prognosis. AIM: To define the natural history of NSE in an Irish cohort. METHODS: Patients with a finding of NSE were identified from a database. Subsequent investigations, treatments and diagnosis were recorded. Patients were grouped based on ultimate diagnosis: Crohn's disease (CD), Irritable bowel syndrome (IBS), NSAIDs enteritis (NSAIDs), persistent NSE and no significant disease (NAD). RESULTS: 88 patients, 46 (52%) male, mean age 52 ± 17.8 years were included with a mean follow up of 23 ± months. The ultimate diagnoses were NAD = 43 (49%), CD = 17 (19%), IBS = 14 (16%), NSAIDs = 12 (14%) and persistent NSE = 2 (2%). Significantly, more patients diagnosed with CD on follow up were referred with suspected CD. CD = 14/17 (82%) vs 13/57 (23%), p < 0.001. While a diagnosis of CD was associated with a positive baseline Lewis score (> 135); 11/17 (65%) CD versus 16/ 71 (23%). Female gender was associated with an ultimate diagnosis of IBS (OR 5, p < 0.02). Older age was associated with NSAIDs enteritis, while more subjects without significant gastrointestinal disease were anemic on presentation. CONCLUSION: The majority (49%) of NSE patients do not develop significant small bowel disease. CD occurred in 19% of NSE patients on follow up. Clinical suspicion and capsule severity are predictive of Crohn's disease on initial CE.

Lower gastrointestinal symptoms and symptoms-based triaging systems are poor predictors of clinical significant disease on colonoscopy.

Introduction: Lower gastrointestinal symptoms (LGS) are a common cause of referral to the gastroenterology service. International guidelines are available to prioritise referrals. Some studies have reported that symptoms alone are a poor marker of clinically significant disease (CSD) but symptoms remain the main way to prioritise referrals in routine clinical practice. Aims/background: To correlate LGS with colonoscopy findings in an unselected patient cohort and to investigate whether using National Institute for Health and Care Excellence (NICE) guidelines improve risk stratification. Method: Colonoscopy data over a 2-year period were obtained from our endoscopy database. Only patients with assessment of symptoms as their primary indication for colonoscopy were included. Patient records were retrospectively reviewed. Exclusion criteria: known inflammatory bowel disease (IBD), familial cancer syndromes, polyp and colorectal cancer (CRC) surveillance, and prior colonoscopy within 5 years. Demographics, symptoms and colonoscopy findings were recorded and analysed. Results: 1116 cases were reviewed; 493 (44%) males, age 54.3 years (16-91). CSD occurred in only 162 (14.5%); CRC 19 (1.7%), high-risk adenoma 40 (3.6%), inflammation 97 (8.7%) (IBD 65 (5.8%), microscopic colitis 9 (0.8%) and indeterminate-inflammation 23 (2%)), angiodysplasia 6 (0.5%). Diarrhoea gave the highest diagnostic yield for CSD of 5.3% (OR 3.15, 95% CI 2.2 to 4.7, p<0.001), followed by PR bleeding, 2.9% (OR 1.9, 95% CI 1.24 to 2.9, p=0.003). Weight loss gave the lowest diagnostic yield of 0.4%; (OR 0.79, 95% CI 0.28 to 2.24, p=0.65). 592 (53%) and 517 (46%) fitted the NICE guidelines for CRC and IBD, respectively. Using NICE positivity improved detection but overall yield remained low 3% vs 0.4% (OR 7.71, 95% CI 1.77 to 33.56, p=0.0064) for CRC, and 9% vs 2.8% (OR 3.5, 95% CI 1.99 to 6.17, p<0.0001) for IBD. Conclusions: The overall prevalence of CSD in our unselected symptomatic patients is low (14.5%). A holistic approach including combining symptoms and demographics with novel tools including stool biomarkers and minimally invasive colonoscopy alternatives should be applied to avoid unnecessary colonoscopy.

Predicting pathology on small bowel capsule endoscopy: a good FIT.

Background and study aims Small bowel capsule endoscopy [SBCE) has an established role in investigating suspected small bowel bleeding [SSBB). Identification of a biomarker to predict pathology would maximize utility of this valuable diagnostic modality. This study aimed to investigate if fecal immunochemical test [FIT) could predict likelihood of small bowel pathology on SBCE. Patients and methods Patients referred for SBCE to investigate anaemia or suspected small bowel bleeding were prospectively recruited. All patients had negative upper and lower endoscopy prior to referral. A FIT ≥ 45 ug Hb/g was considered positive. SBCE was positive if a potential source of SSBB was identified. The primary endpoint was correlation between FIT and positive SBCE. Secondary endpoints were correlation between anemia and SBCE and a combination of anemia plus FIT and SBCE. Results Fifty-one patients were included in the final study cohort. 29.4 % had a positive FIT, 33.3 % were anemic, and 25.5 % patients had significant SBCE findings. There was a statistically significant association between positive FIT and pathology on SBCE (OR 12, 95 % CI [2.8 - 51.9), P  = 0.001). Sensitivity and specificity of positive FIT in predicting SBCE findings were 69 % and 84 %, respectively. A normal Hb had an NPV of 83 % (OR 0.30, P  = 0.09). Combining Hb and FIT was statistically significant in predicting pathology on SBCE (OR 9.14, 67 % PPV, 82 % NPV, P  = 0.025). Conclusion FIT ≥ 45 ug Hb/g is a useful tool in predicting small bowel pathology on SBCE. Use of this biomarker alone, or in combination with serum haemoglobin, has value as a screening tool and may help to better triage patients referred for SBCE.

Adherence to European Polypectomy Guidelines: Retrospective Experience from a Tertiary Irish Hospital.

BACKGROUND AND STUDY AIM: The European guidelines for colorectal cancer screening state that snare resection should remove any polyps ≥5 mm. This study aimed to investigate if these new guidelines are adhered to in clinical practice. PATIENTS AND METHODS: This study consists of patients who underwent colonoscopies in Tallaght Hospital, Dublin (AMNCH), between 2012 and 2015. The size of the polyp, the method of removal, and the subspecialty and grade of the endoscopists were all recorded. RESULTS: 6,000 colonoscopies were reviewed and 687 (12.5%) of these patients were found to have polyps. In 655 (95%) colonoscopies, the caecum was positively identified. In all, 371 (54%) of the polyps detected were < 5 mm; resection via forceps was carried out in n405 cases (59%). Overall, 16% (n = 45) of the polyps > 5 mm underwent resection with forceps, showing that the new European guidelines are not being tightly adhered to. CONCLUSIONS: This study found an 84% compliance with polypectomy resection guidelines which is an improvement on previous studies. However, endoscopist grade significantly affected compliance and may reflect overall competency, highlighting the need for specific training in snare polypectomy techniques.

Golimumab effectiveness and safety in clinical practice for moderately active ulcerative colitis.

BACKGROUND AND AIMS: Golimumab (GLB) is an antitumour necrosis factor-α (anti-TNF) therapy that has shown efficacy as induction and maintenance therapy for ulcerative colitis (UC). We aimed to describe the outcome of GLB therapy for UC in a real-world clinical practice. PATIENTS AND METHODS: Consecutive patients receiving GLB for UC in six Irish Academic Medical Centres were identified. The primary study endpoint was the 6-month corticosteroid-free remission rate. The secondary endpoints included the 3-month clinical response, time free of GLB discontinuation and adverse events. RESULTS: Seventy-two patients were identified [57% men; median (range) age of 41.4 years (20.3-76.8); disease duration 6.6 years (0-29.9); follow-up 8.7 months (0.4-39.2)]. Sixty-four percent of patients were anti-TNF naive. The 3-month clinical response and the 6-month corticosteroid-free remission rates were 55 and 39%, respectively. Forty-four percent of patients discontinued GLB during the follow-up, median (95% confidence interval) time to GLB discontinuation 18.7 months (9.2-28.1). A C-reactive protein more than 5 mg/l at baseline was associated with failure to achieve 6-month corticosteroid-free remission and a shorter time to GLB discontinuation, odds ratio 0.2 (0.1-0.7), P=0.008, and hazard ratio (95% confidence interval) 2.8 (1.3-5.7), P=0.007, respectively. Adverse events occurred in 7% of patients (n=5), all of which were minor and self-limiting. CONCLUSION: These real-world clinical data suggest that GLB is an effective and safe therapy for a UC cohort with significant previous anti-TNF exposure. An elevated baseline C-reactive protein, likely reflective of increased inflammatory burden, is associated with a reduced likelihood of a successful outcome of GLB therapy.

One-Year Clinical Outcomes in an IBD Cohort Who Have Previously Had Anti-TNFa Trough and Antibody Levels Assessed.

BACKGROUND: Loss of response (LOR) is a big concern for anti-TNFa therapies in inflammatory bowel disease. Immunomonitoring may be useful to optimize response rates and overcome secondary LOR. METHODS: This was an observational retrospective cohort study of a group of patients with inflammatory bowel disease on infliximab (IFX) and adalimumab (ADA) who had anti-TNFa trough and antibody levels measured, during maintenance phase of treatment. Anti-TNFa trough and antibody levels were measured using standard enzyme-linked immunosorbent assay techniques. Baseline patient characteristics were determined and patients were reviewed 1 year later. Clinical assessment took place with partial Mayo scores for ulcerative colitis and Harvey-Bradshaw index for Crohn's disease. C-reactive protein (CRP) and albumin were also measured. Poor outcomes were defined as the following: need for rescue steroids, dose intensification, surgery, or treatment discontinuation. RESULTS: Seventy-four patients were included in the study, 37 (50%) were female, mean age 41 years, 61 (82%) had Crohn's disease, and 42 (57%) ulcerative colitis. Forty-two (57%) patients received IFX and 32 (43%) ADA. Mean IFX trough was 3.6 µg/mL and mean ADA troughs were 3.78 µg/mL. Twenty-seven percent of patients (n = 20) overall had a poor outcome, with a similar proportion in each group 24% (n = 10) IFX and 31% (n = 10) ADA (P value 0.24). Of the cohort, 14.2% (6/42) treated with IFX had subtherapeutic trough levels, 6.2% (2/32) of ADA patients had a trough level <1 µg/mL (P value = 0.273) There was no difference in mean trough according to outcome (4.9 µg/mL poor versus 5.4 µg/mL good, P value 0.14). Low IFX trough levels did correlate with high CRP, low albumin and response rates, mean CRP 6.66 µg/mL (n = 3), mean albumin 37 g/L for patients with low trough levels and poor response versus CRP 2.0 µg/mL (n = 24), mean albumin 43 g/L for patients with high trough levels and good response (P = 0.009, 95% confidence interval, -0.78 to -0.12). CONCLUSIONS: LOR is still a big concern with anti-TNFa therapies. Stand-alone anti-TNFa trough and antibody levels are not useful at predicting LOR/disease progression at 1 year, but low trough levels do correlate well with elevated CRP, hypoalbuminaemia, and poor response rates.

Positive relationship between infliximab and adalimumab trough levels at completion of induction therapy with clinical response rates, at a tertiary referral center.

BACKGROUND AND AIM: Anti-tumor necrosis factor alpha (TNFα) therapies have improved outcomes for patients with inflammatory bowel disease. The aim of this study was to explore the relationship between infliximab (IFX) and adalimumab (ADL) trough and antibody levels with clinical response rates at the end of induction. METHODS: This was a prospective, single-center study. Patients were recruited from July 2015 to August 2016. Inclusion criteria were all inflammatory bowel disease patients older than 17 years who started treatment with IFX or ADL. Baseline clinical disease activity indexes were performed. Clinical response was defined as HBI ≤3 or partial Mayo score ≤4% or <30% reduction from baseline. Anti-TNFα trough and antibody levels were measured using standard ELISA techniques. RESULTS: Thirty-five patients were recruited, of whom 23 had Crohn's disease and 12 had ulcerative colitis. Eighteen were treated with ADL and 17 with IFX. The mean age of the cohort was 40.3 years, 62.9% were females, 34.3% were on concomitant thiopurines, and 25.7% had prior anti-TNFα exposure. Overall response rate was 51.4%, 33.3% for ADL and 70.6% for IFX.Mean trough levels were 12.5 µg/mL for IFX and 4.4 µg/mL for ADL. There was a clear link between higher anti-TNFα trough levels at the end of induction with clinical response rates. For IFX, mean trough level was 16.4 µg/mL for responders versus 5.3 µg/mL for non-responders (P = 0.026). Area under the curve for association of IFX level at induction with clinical response was 0.864 (P = 0.0001). Similar link was present between higher ADL levels with clinical response, although not statistically significant. CONCLUSION: Higher trough levels at the end of induction are associated with improved response. Ongoing work will define optimal targets at this key timeframe.

Long-acting somatostatin analogues provide significant beneficial effect in patients with refractory small bowel angiodysplasia: Results from a proof of concept open label mono-centre trial.

INTRODUCTION: Small bowel angiodysplasias account for over 50% of causes of small bowel bleeding and carry a worse prognosis than lesions located elsewhere in the gastrointestinal tract. Re-bleeding rates are high even after first-line endoscopic therapy and are associated with high levels of morbidity for affected patients. Small trials of long-acting somatostatin analogues have shown promising results but have not yet been assessed in patients with refractory small bowel disease. AIM: The purpose of this study was to assess the effect of long-acting somatostatin analogues in reducing re-bleeding rates and transfusion requirements, and improving haemoglobin levels in patients with refractory small bowel angiodysplasia. METHODS: Patients with refractory small bowel angiodysplasia were treated with 20 mg of long-acting octreotide for a minimum of three months. Response was assessed according to: rates of re-bleeding, haemoglobin levels, transfusion requirements, and side effects. RESULTS: A total of 24 patients were initially treated and 20 received at least three doses. Rates of complete, partial and non-response were 70%, 20% and 10% respectively. Average haemoglobin rates increased from 9.19 g/dl to 11.35 g/dl (p = 0.0027, 95% confidence interval (CI) -3.5 to -1.1) in the group overall and 70% remained transfusion-free after a mean treatment duration of 8.8 months. The rate of adverse events was higher than previously reported at 30%. CONCLUSION: Long-acting somatostatin analogues offer a therapeutic advantage in a significant proportion of patients with small bowel angiodysplasia. With careful patient selection and close observation, a long-acting somatostatin analogue should be considered in all patients with persistent anaemia attributable to refractory disease in conjunction with other standard treatments.

The natural history of small bowel angiodysplasia.

BACKGROUND: Small bowel angiodysplasias (SBA) account for 50% of obscure gastrointestinal bleeding. Lesions bleed recurrently and current treatments are relatively ineffective at reducing re-bleeding. Little is known about the natural history of SBA which is needed to guide treatment decisions and counsel patients on prognosis. AIM: The aim of this study is to describe the natural history of a cohort of patients with SBA. METHODS: Patients with SBA were identified retrospectively and clinical and outcome information were collected. Logistic regression analysis was performed to identify factors associated with re-bleeding. RESULTS: SBAs were found in 86 patients of which 54% (n = 47) were female, and the average age was 71.6 years. The majority (69%) had multiple lesions, mean of 2.76/patient, and 65% were located in the jejunum. Follow-up was available in 65% (n = 56). There was a significant increase in haemoglobin level from 10.05g/dL to 11.94g/dL, p < 0.001 after mean follow up of 31.9 (6-62) months. Re-bleeding events occurred in 80% (n = 45), with an average of 2.91/person. The mean interval between diagnosis and the first re-bleeding event was 10.7 months. Of the group overall, 70% (n = 40) required transfusions during follow up, and 67% required hospitalisation due to re-bleeding. About 50% received a directed treatment, including argon plasma coagulation, somatostatin analogues, or surgical resection. A total of 3.5% (n = 2) died as a direct consequence of bleeding from SBAs. Multiple lesions (p = 0.048) and valvular heart disease (p = 0.034) were predictive of re-bleeding. CONCLUSION: Our results show the significant impact of SBA on patients' morbidity, with high rates of re-bleeding, persistent anaemia and a mortality rate of 3.5%, despite the use of currently available medical and endoscopic therapies.

Long-term assessment of clinical response to adalimumab therapy in refractory ulcerative colitis.

INTRODUCTION: The role of antitumour necrosis factor agents, in particular infliximab in ulcerative colitis (UC) has been well established. More recently adalimumab, a fully humanized antitumour necrosis factor α monoclonal antibody, was licensed for refractory moderately active UC in 2012. Available outcome data for adalimumab from routine clinical practice is limited. AIMS: To evaluate the clinical response and remission to adalimumab in a cohort of UC patients. METHODS: Patients with UC treated with adalimumab were identified from our inflammatory bowel disease database from 2007. A retrospective chart review was undertaken. Demographic and clinical data were recorded including a Mayo score and C-reactive protein (CRP) where available. All patients received standard induction subcutaneous therapy (160/80/40 mg) followed by a maintenance dose of 40 mg fortnightly. Clinical and biochemical response was assessed at 6 and 12 months. Clinical response was defined by a reduction in Mayo score more than or equal to 3, whereas clinical remission was defined by a total score of 2 or less. Dose adjustments and adverse events were also noted. RESULTS: In all, 52 patients were identified. Of these, 65% (n=34) were male and the mean age was 45 years (range 23-72 years). A total of 65% (n=34) had left sided disease, 31% (n=16) pancolitis and 4% (n=2) proctitis. The majority commenced adalimumab due to a loss of response to immunomodulator therapy (n=45, 87%), whereas the remaining 13% (n=7) had loss of response or been intolerant to infliximab. The mean disease duration was 8 years (1-29 years). At baseline 85% (n=44) had moderate disease and 15% (n=8) had mild disease. The baseline mean CRP was 13.5 mg/l (range 1-82 mg/l) and the mean Mayo score was 6 (range 4-10). The mean duration of treatment was 18.5 months (range 4-95 months). Follow-up data was available in 46 (88%) and 37 (71%) patients at 6 and 12 months. Overall there was a statistically significant improvement in mean partial Mayo score on follow-up; 6 months=2 [P=0.0001, 95% confidence interval (CI) 2.99-4.55], 12 months=2 (P=0.0001, 95% CI 2.74-4.46). While 65% (n=34) and 52% (n=27) had a clinical response at 6 and 12 months, respectively, 52% (n=27) and 42% (n=22) were in remission. Overall mean CRP normalized at 6 months (P=0.002, 95% CI 3.31-15.1). Of note 25% (n=13) required dose escalation during follow-up, while treatment was discontinued by seven patients, five (71%) due to a loss of response, the remaining two (29%) due to an adverse event. CONCLUSION: Our study shows adalimumab is an effective and safe long-term therapy for moderately active UC refractory to other treatments. While this data is encouraging, further work is required on patient selection and to determine the impact of treatment on both natural history and quality of life.

Impact of the Collaborative Pharmaceutical Care at Tallaght Hospital (PACT) model on medication appropriateness of older patients.

OBJECTIVES: A high prevalence of potentially inappropriate prescribing (PIP) has been identified in older patients in Ireland. The impact of the Collaborative Pharmaceutical Care at Tallaght Hospital (PACT) model on the medication appropriateness of acute hospitalised older patients during admission and at discharge is reported. METHODS: Uncontrolled before-after study. The study population for this study was medical patients aged ≥65 years, using ≥3 regular medicines at admission, taken from a previous before-after study. Standard care involved clinical pharmacists being ward-based, contributing to medication history taking and prescription review, but not involved at discharge. The innovative PACT model involved clinical pharmacists being physician team-based, leading admission and discharge medication reconciliation and undertaking prescription review, with authority to change the prescription during admission or at discharge. The primary outcome was the Medication Appropriateness Index (MAI) score applied pre-admission, during admission and at discharge. RESULTS: Some 108 patients were included (48 PACT, 60 standard). PACT significantly improved the MAI score from pre-admission to admission (mean difference 2.4, 95% CI 1.0 to 3.9, p<0.005), and from pre-admission to discharge (mean difference 4.0, 95 CI 1.7 to 6.4, p<0.005). PACT resulted in significantly fewer drugs with one or more inappropriate rating at discharge (PACT 15.0%, standard 30.5%, p<0.001). The MAI criteria responsible for most inappropriate ratings were 'correct directions' (4.8% PACT, 17.3% standard), expense (5.3% PACT, 5.7% standard) and dosage (0.6% PACT, 4.0% standard). PACT suggestions to optimise medication use were accepted more frequently, and earlier in the hospital episode, than standard care (96.7% PACT, 69.3% standard, p<0.05). CONCLUSIONS: Collaborative pharmaceutical care between physicians and pharmacists from admission to discharge, with authority for pharmacists to amend the prescription, improves medication appropriateness in older hospitalised Irish patients.

A randomized-controlled study to compare the efficacy of sequential therapy with standard triple therapy for Helicobacter pylori eradication in an Irish population.

INTRODUCTION: Eradication rates for the standard first-line triple therapy for Helicobacter pylori infection have decreased in recent years. Sequential therapy has been suggested as an alternative. The efficacy of sequential therapy has not been assessed to date in an Irish population. OBJECTIVE: The aim of this study was to compare the efficacy of standard triple therapy with sequential therapy for H. pylori eradication. PATIENTS AND METHODS: A prospective randomized-controlled study was carried out. Treatment-naive H. pylori-infected patients were randomized to receive either standard triple therapy or sequential therapy. RESULTS: In all, 87 eligible patients were recruited into the study, one of whom dropped out. Fifty-one per cent (N=44) patients received standard triple therapy and 49% (N=42) patients received sequential therapy. The eradication efficacy by intention-to-treat analysis was 56.8% [N=25/44; 95% confidence interval (CI) 42.2-71.4%] for standard triple therapy and 69% (N=29/42; 95% CI 55.0-83.0%) for sequential therapy. The eradication rates by per-protocol analysis for standard triple therapy and sequential therapy were 61% (N=25/41; 95% CI 46.1-76.0%) and 69% (N=29/42; 95% CI 55.0-83.0%), respectively. The differences in eradication rates for each treatment by either intention-to-treat or per-protocol analysis were not statistically significant (P=0.24 and 0.44, respectively). In addition, incidence in adverse events was not significantly different between the study groups. The most common adverse event reported was mild nausea at 15% (95% CI 7.5-22.6%). CONCLUSION: Sequential therapy had a nonstatistically significant advantage over standard triple therapy in our patient cohort. However, eradication rates for both standard triple therapy and sequential therapy were suboptimal. Further studies are required to identify potential alternatives to standard first-line triple therapy.

Collaborative pharmaceutical care in an Irish hospital: uncontrolled before-after study.

BACKGROUND: We investigated the benefits of the Collaborative Pharmaceutical Care in Tallaght Hospital (PACT) service versus standard ward-based clinical pharmacy in adult inpatients receiving acute medical care, particularly on prevalence of medication error and quality of prescribing. METHODS: Uncontrolled before-after study, undertaken in consecutive adult medical inpatients admitted and discharged alive, using at least three medications. Standard care involved clinical pharmacists being ward-based, contributing to medication history taking and prescription review, but not involved at discharge. The innovative PACT intervention involved clinical pharmacists being team-based, leading admission and discharge medication reconciliation and undertaking prescription review. Primary outcome measures were prevalence per patient of medication error and potentially severe error. Secondary measures included quality of prescribing using the Medication Appropriateness Index (MAI) in patients aged ≥65 years. FINDINGS: Some 233 patients (112 PACT, 121 standard) were included. PACT decreased the prevalence of any medication error at discharge (adjusted OR 0.07 (95% CI 0.03 to 0.15)); number needed to treat (NNT) 3 (95% CI 2 to 3) and no PACT patient experienced a potentially severe error (NNT 20, 95% CI 10 to 142). In patients aged ≥65 years (n=108), PACT improved the MAI score from preadmission to discharge (Mann-Whitney U p<0.05; PACT median -1, IQR -3.75 to 0; standard care median +1, IQR -1 to +6). CONCLUSIONS: PACT, a collaborative model of pharmaceutical care involving medication reconciliation and review, delivered by clinical pharmacists and physicians, at admission, during inpatient care and at discharge was protective against potentially severe medication errors in acute medical patients and improved the quality of prescribing in older patients.

Isolated active ileitis: is it a mild subtype of Crohn's disease?

BACKGROUND: Ileal intubation is being increasingly performed at colonoscopy and has in turn lead to an increasingly recognized subgroup of patients-those with mild terminal ileal inflammation, an entity that we have coined isolated active ileitis (IAI). The aims of this study were to define the natural history of IAI and determine if IAI shares a similar genetic and serologic profile with Crohn's disease (CD). METHODS: Patients with IAI were identified from our institution's histopathology and endoscopy databases. Cases attended for repeat colonoscopy and blood were analyzed for the expression of antineutrophil cytoplasmic antibody, anti-OmpC, anti-Saccharomyces cerevisiae antigen (ASCA) IgA, ASCA IgG, and anti-CBir antibodies and NOD2 genotyping. Age and sex-matched healthy controls, CD, and UC cases were also recruited. RESULTS: Sixty-three patients with IAI were recruited. There was no significant difference in the prevalence of antibodies between IAI cases and healthy controls for antineutrophil cytoplasmic antibody, OmpC, ASCA IgA, or ASCA IgG. The presence of all 5 antibodies was significantly higher in the CD group than the IAI group, P < 0.05. There were 28.6% of CD cases that carried one or more NOD2 variants, compared to 26.2% of the IAI cohort and 6.1% of healthy controls. Forty-three cases underwent follow-up ileocolonoscopy. Six of 43 cases (14%) had definite CD. CONCLUSIONS: A majority of IAI cases developed persistent symptoms and terminal ileal abnormalities; however, only 14% developed classical, histological, or radiological features of CD. Although patients with IAI have a low level of seropositivity, similar to healthy controls, they do share an excess of NOD2 mutations with CD cases.

Eosinophilic oesophagitis: an Irish experience.

INTRODUCTION: Eosinophilic oesophagitis is a recently recognized oesophageal disorder characterized by a combination of clinical and endoscopic features as well as the histological finding on oesophageal biopsy of greater than 15 eosinophils per high powered field. Recent reports suggest eosinophilic oesophagitis is increasing in incidence and this increase cannot be fully explained by increased recognition of the disorder. The aim of this retrospective study was to assess the incidence of eosinophilic oesophagitis within the catchment area of a tertiary referral hospital in southwest Dublin, Ireland. METHODS: The histopathology database at the Adelaide and Meath Hospital was used to identify all oesophageal biopsies obtained between January 2000 and July 2008 reported to show evidence of oesophagitis. Biopsy samples with greater than 15 eosinophils per high powered field in at least two fields were highlighted as possible eosinophilic oesophagitis. The oesophageal biopsies of patients identified in this way were reviewed by a histopathologist with a special expertise in gastroenterology for features suggestive of eosinophilic oesophagitis. RESULTS: Twenty-five thousand three hundred and sixty-five upper gastrointestinal endoscopies were performed between January 2000 and July 2008. A total of 11 072 sets of oesophageal biopsies were taken and 1364 (12.3%) of these revealed evidence of oesophagitis. Only 13 (0.1%) patients had oesophageal biopsies showing greater than 15 eosinophils per high powered field. The median age of this patient group was 23 years (interquartile range 10.5-50.5 years), with 46% of patients under 18 years at the time of diagnosis. The male to female ratio was 5.5 : 1 compared with 1.1 : 1 in the oesophagitis group as a whole, (P=0.002). There was no significant association between endoscopic findings or presenting complaints and the average number of eosinophils per high powered field. The average number of biopsies taken in patients with endoscopic findings suggestive of eosinophilic oesophagitis was 3.75 compared with 1 in patients without those features, (P=0.01). CONCLUSION: Our findings suggest that eosinophilic oesophagitis is a rare disorder predominantly affecting young men.

Safety of infliximab in 10 years of clinical practice.

UNLABELLED: Assessment of the long-term safety of anti-tumour necrosis factor therapies is vital for the safe treatment of inflammatory bowel disease, a disease affecting a young cohort of patients. AIMS: The aim of this retrospective study was to assess the safety and long-term outcome of infliximab use in clinical practice in our institution on an intention to treat basis over the 10-year period from December 1998 to 31 December 2008. METHODS: All cases receiving infliximab for ulcerative colitis or Crohn's disease over a 10-year period were identified from hospital pharmacy records. The study was based on a single centre cohort, with an unselected patient group. RESULTS: A total of 271 patients were identified as receiving infliximab for either Crohn's disease or ulcerative colitis over the 10-year study period. In total, 2169 infusions were given to the patient cohort. Fifty adverse events led to discontinuation of infliximab therapy in 47 cases. Two patients stopped due to neurological complications. There were six malignancies diagnosed within the cohort during the study period. Four of these were diagnosed while the individual was receiving Infliximab and two occurred at an interval of 21-52 months post their final infliximab infusion. A total of five deaths (1.5%) were observed during the study period. CONCLUSION: Infliximab therapy seems to be safe and efficacious in the long term. Although the development of malignancy remains a concern, we have not seen an increased risk of serious infection within our cohort.