Donald Macintosh - Academia.edu (original) (raw)
Papers by Donald Macintosh
Gastroenterology, 2009
Background: Endoscopy units' delivery of timely service, consistent with published guidelines (Ca... more Background: Endoscopy units' delivery of timely service, consistent with published guidelines (Can J Gastro 2006;20:411) depends, partly, on efficient use of available resources. However, there is no mechanism to allow direct widespread monitoring of systemic quality indicators, such as booking appropriateness and bowel preparation adequacy in Canadian endoscopy units. Aim: To determine endoscopy unit quality indicators in the context of a national colonoscopy practice audit program. Methods: MDs at 13 centres collected data, in real time, on colonoscopies performed over periods of at least 2 weeks using data collection software (ReForm XT, Goanyware Software, Tulsa, OK) on a smartphone (Treo 650, Palm Inc, Mississauga, ON) with prompt download to a secure website and presentation on a secure website (ECD solutions, Atlanta, GA) for participants' review. Reasons for colonoscopy were classified as 'Investigation of abnormality' (INV), 'Screening' (SCR) and 'Surveillance' (SUR). Bowel preparation quality was rated with the Ottawa scale (Scores-Excellent: 0-4; Poor: 11-14). Results : Since February 2008, 45 endoscopists (34 GIs & 11 surgeons) reported on 822 colonoscopies. Bowel preparation was: excellent: 73.9% and poor: 2.7%. The table shows the proportions of patients (a) colonoscoped at different intervals since their last colonoscopy and (b) in each age group at the time of colonoscopy. Summary: Colonoscopy intervals seem appropriate and most patients have good bowel preparation. However, for SCR patients, 20% are ≤50 yrs old, >10% have had a colonoscopy within <5 yrs and 8% are >70 yrs old. Conclusions: Point-of-care data collection on reasons for colonoscopy and bowel preparation quality facilitates: 1) practice audit by physicians and endoscopy units, and 2) improved resource utilization in the delivery of colonoscopy services. Percentages [95% CI] of patients with respect to interval since last colonoscopy and age '-' No patients in this group.
Gastrointestinal Endoscopy, 2004
It has been suggested that the use of pure-cut electrosurgical current for endoscopic sphincterot... more It has been suggested that the use of pure-cut electrosurgical current for endoscopic sphincterotomy may reduce the risk of post-ERCP pancreatitis. The aim of this study was to determine whether pure-cut current reduces the risk of pancreatitis compared with blend current. Patients were randomly assigned to undergo sphincterotomy over a non-conductive guidewire with 30 W/sec pure-cut current or 30 W/sec blend-2 current by a blinded endoscopist. Serum amylase and lipase levels were determined 1 day before and within 24 hours after ERCP. Post-ERCP pancreatitis was the primary outcome of interest. Secondary outcomes were as follows: severity of immediate bleeding, as graded by a 3-point scale from 1 (no bleeding) to 3 (injection or balloon tamponade therapy required to stop bleeding) and evidence of delayed bleeding 24 hours after ERCP. Analyses were performed in intention-to-treat fashion. A total of 246 patients were randomized (116 pure-cut current, 130 blend current). There were no differences in baseline characteristics between the groups. The overall frequency of post-ERCP pancreatitis was 6.9%, with no significant difference in frequency between treatment arms (pure cut, 7.8% vs. blend, 6.1%; p = 0.62). The difference in rates of pancreatitis between the two groups was 1.7%: 95% CI[-4.8%, 8.2%]. Six patients (2.4%) had delayed bleeding after ERCP, of which two required transfusion. There was a significant increase in minor bleeding episodes (grade 2) in the pure-cut group (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.0001). Delayed episodes of bleeding were equal (n = 3) in each arm. The type of current used when performing endoscopic sphincterotomy does not appear to alter the risk of post-ERCP pancreatitis. The selection of electrosurgical current for biliary endoscopic sphincterotomy should be based on endoscopist preference.
The Lancet, 2015
Conventional management of Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;... more Conventional management of Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease features incremental use of therapies. However, early combined immunosuppression (ECI), with a TNF antagonist and antimetabolite might be a more effective strategy. We compared the efficacy of ECI with that of conventional management for treatment of Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease. In this open-label cluster randomised controlled trial (Randomised Evaluation of an Algorithm for Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s Treatment, REACT), we included community gastroenterology practices from Belgium and Canada that were willing to be assigned to either of the study groups, participate in all aspects of the study, and provide data on up to 60 patients with Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease. These practices were randomly assigned (1:1) to either ECI or conventional management. The computer-generated randomisation was minimised by country and practice size. Up to 60 consecutive adult patients were assessed within practices. Patients who were aged 18 years or older; documented to have Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease; able to speak or understand English, French, or Dutch; able to access a telephone; and able to provide written informed consent were followed up for 2 years. The primary outcome was the proportion of patients in corticosteroid-free remission (Harvey-Bradshaw Index score ≤4) at 12 months at the practice level. This trial is registered with ClinicalTrials.gov, number NCT01030809. This study took place between March 15, 2010, and Oct 1, 2013. Of the 60 practices screened, 41 were randomly assigned to either ECI (n=22) or conventional management (n=19). Two practices (one in each group) discontinued because of insufficient resources. 921 (85%) of the 1084 patients at ECI practices and 806 (90%) of 898 patients at conventional management practices completed 12 months follow-up and were included in an intention-to-treat analysis. The 12 month practice-level remission rates were similar at ECI and conventional management practices (66·0% [SD 14·0] and 61·9% [16·9]; adjusted difference 2·5%, 95% CI -5·2% to 10·2%, p=0·5169). The 24 month patient-level composite rate of major adverse outcomes defined as occurrence of surgery, hospital admission, or serious disease-related complications was lower at ECI practices than at conventional management practices (27·7% and 35·1%, absolute difference [AD] 7·3%, hazard ratio [HR]: 0·73, 95% CI 0·62 to 0·86, p=0·0003). There were no differences in serious drug-related adverse events. Although ECI was not more effective than conventional management for controlling Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease symptoms, the risk of major adverse outcomes was lower. The latter finding should be considered hypothesis-generating for future trials. ECI was not associated with an increased risk of serious drug-related adverse events or mortality. AbbVie Pharmaceuticals.
Canadian journal of gastroenterology = Journal canadien de gastroenterologie, 2013
Increasing use of gastrointestinal endoscopy, particularly for colorectal cancer screening, and i... more Increasing use of gastrointestinal endoscopy, particularly for colorectal cancer screening, and increasing emphasis on health care quality highlight the need for endoscopy facilities to review the quality of the service they offer. To adapt the United Kingdom Global Rating Scale (UK-GRS) to develop a web-based and patient-centred tool to assess and improve the quality of endoscopy services provided. Based on feedback from 22 sites across Canada that completed the UK endoscopy GRS, and integrating results of the Canadian consensus on safety and quality indicators in endoscopy and other Canadian consensus reports, a working group of endoscopists experienced with the GRS developed the GRS-Canada (GRS-C). The GRS-C mirrors the two dimensions (clinical quality and quality of the patient experience) and 12 patient-centred items of the UK-GRS, but was modified to apply to Canadian health care infrastructure, language and current practice. Each item is assessed by a yes⁄no response to eight...
Canadian journal of gastroenterology = Journal canadien de gastroenterologie, 2011
Point-of-care practice audits allow documentation of procedural outcomes to support quality impro... more Point-of-care practice audits allow documentation of procedural outcomes to support quality improvement in endoscopic practice. To evaluate a colonoscopists' practice audit tool that provides point-of-care data collection and peer-comparator feedback. A prospective, observational colonoscopy practice audit was conducted in academic and community endoscopy units for unselected patients undergoing colonoscopy. Anonymized colonoscopist, patient and practice data were collected using touchscreen smartphones with automated data upload for data analysis and review by participants. The main outcome measures were the following colonoscopy quality indicators: colonoscope insertion and withdrawal times, bowel preparation quality, sedation, immediate complications and polypectomy, and biopsy rates. Over a span of 16 months, 62 endoscopists reported on 1279 colonoscopy procedures. The mean cecal intubation rate was 94.9% (10th centile 84.2%). The mean withdrawal time was 8.8 min and, for no...
The American Journal of Gastroenterology, 2000
Meta-analysis was conducted to evaluate the efficacy of endoscopic variceal ligation (EVL) for pr... more Meta-analysis was conducted to evaluate the efficacy of endoscopic variceal ligation (EVL) for primary prophylaxis of variceal bleeding. Only randomized clinical control trials comparing EVL to control were included in the meta-analysis.
The American Journal of Gastroenterology, 2000
OBJECTIVE: Various therapies have been studied for the treatment of Crohn's disease, including an... more OBJECTIVE: Various therapies have been studied for the treatment of Crohn's disease, including antimycobacterial therapy. Meta-analysis was used to evaluate the effect of antimycobacterial therapy in patients with Crohn's disease.
Reviews, 1996
ABSTRACT To evaluate the effects of anti-tuberculous therapy for the maintenance of remission in ... more ABSTRACT To evaluate the effects of anti-tuberculous therapy for the maintenance of remission in patients with Crohn's disease. We searched the Inflammatory Bowel Disease Trials Register, the Cochrane Controlled Trials Register and MEDLINE from 1966 to 1998 (supplemented by a manual search of Index Medicus from 1966 to 1994). We also searched for abstracts in Gut, Gastroenterology, and The American Journal of Gastroenterology from 1990 to 1996. Date of most recent search: August 1998. Randomized trials of anti-tuberculous therapy in patients with Crohn's disease. Data on the number of patients maintaining remission for each treatment group were abstracted. These data were pooled to yield Mantel-Haenszel odds ratios and numbers needed to treat for maintenance of remission in treated versus control groups. A total of seven randomized trials which included 355 patients were identified. Two trials used anti-tuberculous therapy (clofazimine or clofazimine, rafmpin, ethambutol, and dapsone) in combination with corticosteroids to induce remission. Maintenance therapy consisted of the anti-tuberculous agents without corticosteroids. Control patients received corticosteroids to induce remission but no anti-tuberculous therapy. The analysis of all seven trials yielded an odds ratio for maintenance of remission of 1.36 (95% CI 0.87-2. 13). Removing the two studies that were published as abstracts did not significantly affect this result: the pooled odds ratio was 1.14 (95% CI 0.71-1.83). The two trials reported as abstracts were excluded from subgroup analyses because they did not include any information on adjunct therapy. Subgroup analysis of the two trials which used steroids to induce remission yielded an odds ratio for maintenance of remission of 3.37 (95% CI 1.38-8.24). The number needed to treat was three. However, these two trials included only 89 patients, and the results should be interpreted with caution. The remaining three trials compared the combination of anti-tuberculous therapy and 'standard therapy' with 'standard therapy alone'. The pooled odds ratio was 0.70 (95% CI 0.39-1.25). Anti-tuberculous therapy may be effective in maintaining remission in patients with Crohn's disease when remission has been induced with corticosteroids combined with anti-tuberculous therapy. However, the results which support this conclusion come from a subgroup of only two trials with small numbers of patients and should be interpreted with caution. Use of this therapy cannot be recommended on the basis of this evidence.
Gut, 2007
Background: Adalimumab induced clinical remission after four weeks in patients with active Crohn'... more Background: Adalimumab induced clinical remission after four weeks in patients with active Crohn's disease in the CLASSIC I trial.
Gastrointestinal Endoscopy, 2006
Cannulation of the common bile duct (CBD) is the first step in endoscopic retrograde cholangiopan... more Cannulation of the common bile duct (CBD) is the first step in endoscopic retrograde cholangiopancreatography (ERCP). Cannulation difficulty is a known risk factor for post-ERCP complications and may be minimized by the use of a smaller caliber sphincterotome. To compare the efficacy of CBD cannulation with a 4 F versus a 5 F sphincterotome. A randomized controlled trial, with concealed allocation and double-blinding. Adult patients undergoing their first ERCP at a tertiary referral center. Patients were randomized to undergo CBD cannulation with either a 4 F or 5 F sphincterotome. Successful deep cannulation in &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;15 attempts was the primary outcome. Secondary outcomes included number of attempts/time to cannulation, incidence of complications within 24 hours, and overall cannulation success (including patients before and after crossover). Analysis was intention to treat and included standard descriptive and inferential methods. A total of 107 patients were randomized: 51 (4 F) versus 56 (5 F). The majority were female (71%) and white (92%). Baseline demographics, presenting symptoms, and laboratory values were similar between groups. Similar success in initial cannulation was observed: 84.3% (4 F) and 83.9% (5 F). No differences were noted in time to cannulation (5.12 min [SD, 4.8] for 4 F vs 4.46 min [SD, 4.13] for 5 F; p = NS), number of attempts to cannulation (6.2 [SD, 5.2] for 4 F vs 5.7 [SD, 4.9] for 5 F; p = NS), or complications. The overall cannulation success was 92.2% (4 F) and 92.9% (5 F). Premature termination of the trial resulted in decreased power. There exists no significant difference in efficacy between 4 F and 5 F sphincterotomes. The choice of initial sphincterotome should be dictated by physician preference.
Gastroenterology, 2014
Methotrexate and infliximab are effective therapies for Crohn&amp;amp;amp;amp;amp;amp;amp... more Methotrexate and infliximab are effective therapies for Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease (CD). In the combination of maintenance methotrexate-infliximab trial, we evaluated the potential superiority of combination therapy over infliximab alone. In a 50-week, double-blind, placebo-controlled trial, we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15-40 mg/day) within the preceding 6 weeks. Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg, escalating to 25 mg/week (n = 63), or placebo (n = 63). Both groups received infliximab (5 mg/kg of body weight) at weeks 1, 3, 7, and 14, and every 8 weeks thereafter. Prednisone was tapered, beginning at week 1, and discontinued no later than week 14. The primary outcome was time to treatment failure, defined as a lack of prednisone-free remission (CD Activity Index, &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;150) at week 14 or failure to maintain remission through week 50. Patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; baseline characteristics were similar between groups. By week 50, the actuarial rate of treatment failure was 30.6% in the combination therapy group compared with 29.8% in the infliximab monotherapy group (P = .63; hazard ratio, 1.16; 95% confidence interval, 0.62-2.17). Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein. No clinically meaningful differences were observed in secondary outcomes. Combination therapy was well tolerated. The combination of infliximab and methotrexate, although safe, was no more effective than infliximab alone in patients with CD receiving treatment with prednisone. ClincialTrials.gov number, NCT00132899.
Gastroenterology, 2010
... S1051 Methotrexate for the Prevention of Antibodies to Infliximab in Patients With Crohn&... more ... S1051 Methotrexate for the Prevention of Antibodies to Infliximab in Patients With Crohn&#x27;s Disease. Brian G. Feagan ,; John W. McDonald ,; Remo Panaccione ,; Robert A. Enns ,; Charles N. Bernstein ,; Terry P. Ponich ,; Raymond Bourdages ,; Donald G. MacIntosh ,; ...
Gastroenterology, 2008
Background: The SEDASYS System (SS) is an investigational, computerassisted, personalized sedatio... more Background: The SEDASYS System (SS) is an investigational, computerassisted, personalized sedation system intended to provide endoscopist/nurse teams an "on-label" method to administer propofol sedation for colonoscopy and esophagogastroduodenoscopy (EGD) procedures. This institutional review board-approved study was designed to compare sedation with the SS to the current standard of care (CSC) with midazolam in combination with fentanyl or meperidine. Methods: One thousand subjects (496 SS; 504 CSC) were sedated for 731 colonoscopy and 279 EGDs at 8 sites. Electronic data were captured on a laptop computer. Subject responsiveness was assessed using a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. The primary endpoint was area under the curve (AUC) of oxygen desaturation (SpO 2 Ͻ 90%; ). Secondary endpoints were clinician satisfaction with sedation instrument, patient satisfaction with sedation instrument, time to recover from sedation (scope-out until return to MOAA/S ϭ 5) and duration of deep sedation/ general anesthesia (count of MOAA/S ϭ 1 or 0 during procedure). Results: One thousand subjects were randomized into the study. SS subjects received propofol (mean, 106.2 Ϯ 57.1 mg colonoscopy; 70.1 Ϯ 37.1 EGD) via a variable rate infusion and a single dose of fentanyl as a premedication (mean, 74.0 Ϯ 23.1 g colonoscopy; 65.6 Ϯ 22.4 EGD). CSC subjects received midazolam (8 sites; mean, 4.8 Ϯ 2.2 mg colonoscopy; 4.3 Ϯ 2.1 EGD) plus fentanyl (5 sites; mean, 98.3 Ϯ 31.1 g colonoscopy; 68.5 Ϯ 24.2 EGD) or meperidine (3 sites; mean, 43.9 Ϯ 15.8 mg colonoscopy; 42.3 Ϯ 15.5 EGD). summarizes the results for the primary and secondary endpoints. There were 34 adverse events, 0 serious adverse events, and 0 rescue interventions in the SS arm of the study, compared with 48, 1, and 1 in CSC. Conclusion: In this study physician/ nurse teams were able to safely and effectively administer propofol sedation with the SS during colonoscopy and EGD procedures. SS subjects had significantly lower AUC for oxygen desaturation compared with CSC subjects. Both physicians and subjects were more satisfied with the sedation achieved with the SS. SS subjects were minimally/moderately sedated, recovered quickly, and had minimal AEs.
Gastroenterology, 2006
Tumor necrosis factor blockade has been shown to be an effective treatment strategy in Crohn&... more Tumor necrosis factor blockade has been shown to be an effective treatment strategy in Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease (CD). Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor (TNF). A randomized, double-blind, placebo-controlled, dose-ranging trial was performed to evaluate the efficacy of adalimumab induction therapy in patients with CD. A total of 299 patients with moderate to severe CD naive to anti-TNF therapy were randomized to receive subcutaneous injections at weeks 0 and 2 with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg or placebo. The primary endpoint was demonstration of a significant difference in the rates of remission at week 4 (defined as a Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s Disease Activity Index score &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;150 points) among the 80 mg/40 mg, 160 mg/80 mg, and placebo groups. The rates of remission at week 4 in the adalimumab 40 mg/20 mg, 80 mg/40 mg, and 160 mg/80 mg groups were 18% (P = .36), 24% (P = .06), and 36% (P = .001), respectively, and 12% in the placebo group. Adverse events occurred at similar frequencies in all 4 treatment groups except injection site reactions, which were more common in adalimumab-treated patients. Adalimumab was superior to placebo for induction of remission in patients with moderate to severe Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease naive to anti-TNF therapy. The optimal induction dosing regimen for adalimumab in this study was 160 mg at week 0 followed by 80 mg at week 2. Adalimumab was well tolerated.
Background: This paper summarizes our experiences from a six-month pilot study of a web portal th... more Background: This paper summarizes our experiences from a six-month pilot study of a web portal that provided secure communications, education, and support for self-management by Inflammatory Bowel Disease (IBD) patients. An analysis of "don't know" responses revealed room for improvement in site organization and content analysis.
Gastroenterology, 2009
Background: Endoscopy units' delivery of timely service, consistent with published guidelines (Ca... more Background: Endoscopy units' delivery of timely service, consistent with published guidelines (Can J Gastro 2006;20:411) depends, partly, on efficient use of available resources. However, there is no mechanism to allow direct widespread monitoring of systemic quality indicators, such as booking appropriateness and bowel preparation adequacy in Canadian endoscopy units. Aim: To determine endoscopy unit quality indicators in the context of a national colonoscopy practice audit program. Methods: MDs at 13 centres collected data, in real time, on colonoscopies performed over periods of at least 2 weeks using data collection software (ReForm XT, Goanyware Software, Tulsa, OK) on a smartphone (Treo 650, Palm Inc, Mississauga, ON) with prompt download to a secure website and presentation on a secure website (ECD solutions, Atlanta, GA) for participants' review. Reasons for colonoscopy were classified as 'Investigation of abnormality' (INV), 'Screening' (SCR) and 'Surveillance' (SUR). Bowel preparation quality was rated with the Ottawa scale . Results : Since February 2008, 45 endoscopists (34 GIs & 11 surgeons) reported on 822 colonoscopies. Bowel preparation was: excellent: 73.9% and poor: 2.7%. The table shows the proportions of patients (a) colonoscoped at different intervals since their last colonoscopy and (b) in each age group at the time of colonoscopy. Summary: Colonoscopy intervals seem appropriate and most patients have good bowel preparation. However, for SCR patients, 20% are ≤50 yrs old, >10% have had a colonoscopy within <5 yrs and 8% are >70 yrs old. Conclusions: Point-of-care data collection on reasons for colonoscopy and bowel preparation quality facilitates: 1) practice audit by physicians and endoscopy units, and 2) improved resource utilization in the delivery of colonoscopy services. Percentages [95% CI] of patients with respect to interval since last colonoscopy and age '-' No patients in this group.
Gastroenterology, 2009
Background: Endoscopy units' delivery of timely service, consistent with published guidelines (Ca... more Background: Endoscopy units' delivery of timely service, consistent with published guidelines (Can J Gastro 2006;20:411) depends, partly, on efficient use of available resources. However, there is no mechanism to allow direct widespread monitoring of systemic quality indicators, such as booking appropriateness and bowel preparation adequacy in Canadian endoscopy units. Aim: To determine endoscopy unit quality indicators in the context of a national colonoscopy practice audit program. Methods: MDs at 13 centres collected data, in real time, on colonoscopies performed over periods of at least 2 weeks using data collection software (ReForm XT, Goanyware Software, Tulsa, OK) on a smartphone (Treo 650, Palm Inc, Mississauga, ON) with prompt download to a secure website and presentation on a secure website (ECD solutions, Atlanta, GA) for participants' review. Reasons for colonoscopy were classified as 'Investigation of abnormality' (INV), 'Screening' (SCR) and 'Surveillance' (SUR). Bowel preparation quality was rated with the Ottawa scale (Scores-Excellent: 0-4; Poor: 11-14). Results : Since February 2008, 45 endoscopists (34 GIs & 11 surgeons) reported on 822 colonoscopies. Bowel preparation was: excellent: 73.9% and poor: 2.7%. The table shows the proportions of patients (a) colonoscoped at different intervals since their last colonoscopy and (b) in each age group at the time of colonoscopy. Summary: Colonoscopy intervals seem appropriate and most patients have good bowel preparation. However, for SCR patients, 20% are ≤50 yrs old, >10% have had a colonoscopy within <5 yrs and 8% are >70 yrs old. Conclusions: Point-of-care data collection on reasons for colonoscopy and bowel preparation quality facilitates: 1) practice audit by physicians and endoscopy units, and 2) improved resource utilization in the delivery of colonoscopy services. Percentages [95% CI] of patients with respect to interval since last colonoscopy and age '-' No patients in this group.
Gastrointestinal Endoscopy, 2004
It has been suggested that the use of pure-cut electrosurgical current for endoscopic sphincterot... more It has been suggested that the use of pure-cut electrosurgical current for endoscopic sphincterotomy may reduce the risk of post-ERCP pancreatitis. The aim of this study was to determine whether pure-cut current reduces the risk of pancreatitis compared with blend current. Patients were randomly assigned to undergo sphincterotomy over a non-conductive guidewire with 30 W/sec pure-cut current or 30 W/sec blend-2 current by a blinded endoscopist. Serum amylase and lipase levels were determined 1 day before and within 24 hours after ERCP. Post-ERCP pancreatitis was the primary outcome of interest. Secondary outcomes were as follows: severity of immediate bleeding, as graded by a 3-point scale from 1 (no bleeding) to 3 (injection or balloon tamponade therapy required to stop bleeding) and evidence of delayed bleeding 24 hours after ERCP. Analyses were performed in intention-to-treat fashion. A total of 246 patients were randomized (116 pure-cut current, 130 blend current). There were no differences in baseline characteristics between the groups. The overall frequency of post-ERCP pancreatitis was 6.9%, with no significant difference in frequency between treatment arms (pure cut, 7.8% vs. blend, 6.1%; p = 0.62). The difference in rates of pancreatitis between the two groups was 1.7%: 95% CI[-4.8%, 8.2%]. Six patients (2.4%) had delayed bleeding after ERCP, of which two required transfusion. There was a significant increase in minor bleeding episodes (grade 2) in the pure-cut group (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.0001). Delayed episodes of bleeding were equal (n = 3) in each arm. The type of current used when performing endoscopic sphincterotomy does not appear to alter the risk of post-ERCP pancreatitis. The selection of electrosurgical current for biliary endoscopic sphincterotomy should be based on endoscopist preference.
The Lancet, 2015
Conventional management of Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;... more Conventional management of Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease features incremental use of therapies. However, early combined immunosuppression (ECI), with a TNF antagonist and antimetabolite might be a more effective strategy. We compared the efficacy of ECI with that of conventional management for treatment of Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease. In this open-label cluster randomised controlled trial (Randomised Evaluation of an Algorithm for Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s Treatment, REACT), we included community gastroenterology practices from Belgium and Canada that were willing to be assigned to either of the study groups, participate in all aspects of the study, and provide data on up to 60 patients with Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease. These practices were randomly assigned (1:1) to either ECI or conventional management. The computer-generated randomisation was minimised by country and practice size. Up to 60 consecutive adult patients were assessed within practices. Patients who were aged 18 years or older; documented to have Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease; able to speak or understand English, French, or Dutch; able to access a telephone; and able to provide written informed consent were followed up for 2 years. The primary outcome was the proportion of patients in corticosteroid-free remission (Harvey-Bradshaw Index score ≤4) at 12 months at the practice level. This trial is registered with ClinicalTrials.gov, number NCT01030809. This study took place between March 15, 2010, and Oct 1, 2013. Of the 60 practices screened, 41 were randomly assigned to either ECI (n=22) or conventional management (n=19). Two practices (one in each group) discontinued because of insufficient resources. 921 (85%) of the 1084 patients at ECI practices and 806 (90%) of 898 patients at conventional management practices completed 12 months follow-up and were included in an intention-to-treat analysis. The 12 month practice-level remission rates were similar at ECI and conventional management practices (66·0% [SD 14·0] and 61·9% [16·9]; adjusted difference 2·5%, 95% CI -5·2% to 10·2%, p=0·5169). The 24 month patient-level composite rate of major adverse outcomes defined as occurrence of surgery, hospital admission, or serious disease-related complications was lower at ECI practices than at conventional management practices (27·7% and 35·1%, absolute difference [AD] 7·3%, hazard ratio [HR]: 0·73, 95% CI 0·62 to 0·86, p=0·0003). There were no differences in serious drug-related adverse events. Although ECI was not more effective than conventional management for controlling Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease symptoms, the risk of major adverse outcomes was lower. The latter finding should be considered hypothesis-generating for future trials. ECI was not associated with an increased risk of serious drug-related adverse events or mortality. AbbVie Pharmaceuticals.
Canadian journal of gastroenterology = Journal canadien de gastroenterologie, 2013
Increasing use of gastrointestinal endoscopy, particularly for colorectal cancer screening, and i... more Increasing use of gastrointestinal endoscopy, particularly for colorectal cancer screening, and increasing emphasis on health care quality highlight the need for endoscopy facilities to review the quality of the service they offer. To adapt the United Kingdom Global Rating Scale (UK-GRS) to develop a web-based and patient-centred tool to assess and improve the quality of endoscopy services provided. Based on feedback from 22 sites across Canada that completed the UK endoscopy GRS, and integrating results of the Canadian consensus on safety and quality indicators in endoscopy and other Canadian consensus reports, a working group of endoscopists experienced with the GRS developed the GRS-Canada (GRS-C). The GRS-C mirrors the two dimensions (clinical quality and quality of the patient experience) and 12 patient-centred items of the UK-GRS, but was modified to apply to Canadian health care infrastructure, language and current practice. Each item is assessed by a yes⁄no response to eight...
Canadian journal of gastroenterology = Journal canadien de gastroenterologie, 2011
Point-of-care practice audits allow documentation of procedural outcomes to support quality impro... more Point-of-care practice audits allow documentation of procedural outcomes to support quality improvement in endoscopic practice. To evaluate a colonoscopists' practice audit tool that provides point-of-care data collection and peer-comparator feedback. A prospective, observational colonoscopy practice audit was conducted in academic and community endoscopy units for unselected patients undergoing colonoscopy. Anonymized colonoscopist, patient and practice data were collected using touchscreen smartphones with automated data upload for data analysis and review by participants. The main outcome measures were the following colonoscopy quality indicators: colonoscope insertion and withdrawal times, bowel preparation quality, sedation, immediate complications and polypectomy, and biopsy rates. Over a span of 16 months, 62 endoscopists reported on 1279 colonoscopy procedures. The mean cecal intubation rate was 94.9% (10th centile 84.2%). The mean withdrawal time was 8.8 min and, for no...
The American Journal of Gastroenterology, 2000
Meta-analysis was conducted to evaluate the efficacy of endoscopic variceal ligation (EVL) for pr... more Meta-analysis was conducted to evaluate the efficacy of endoscopic variceal ligation (EVL) for primary prophylaxis of variceal bleeding. Only randomized clinical control trials comparing EVL to control were included in the meta-analysis.
The American Journal of Gastroenterology, 2000
OBJECTIVE: Various therapies have been studied for the treatment of Crohn's disease, including an... more OBJECTIVE: Various therapies have been studied for the treatment of Crohn's disease, including antimycobacterial therapy. Meta-analysis was used to evaluate the effect of antimycobacterial therapy in patients with Crohn's disease.
Reviews, 1996
ABSTRACT To evaluate the effects of anti-tuberculous therapy for the maintenance of remission in ... more ABSTRACT To evaluate the effects of anti-tuberculous therapy for the maintenance of remission in patients with Crohn's disease. We searched the Inflammatory Bowel Disease Trials Register, the Cochrane Controlled Trials Register and MEDLINE from 1966 to 1998 (supplemented by a manual search of Index Medicus from 1966 to 1994). We also searched for abstracts in Gut, Gastroenterology, and The American Journal of Gastroenterology from 1990 to 1996. Date of most recent search: August 1998. Randomized trials of anti-tuberculous therapy in patients with Crohn's disease. Data on the number of patients maintaining remission for each treatment group were abstracted. These data were pooled to yield Mantel-Haenszel odds ratios and numbers needed to treat for maintenance of remission in treated versus control groups. A total of seven randomized trials which included 355 patients were identified. Two trials used anti-tuberculous therapy (clofazimine or clofazimine, rafmpin, ethambutol, and dapsone) in combination with corticosteroids to induce remission. Maintenance therapy consisted of the anti-tuberculous agents without corticosteroids. Control patients received corticosteroids to induce remission but no anti-tuberculous therapy. The analysis of all seven trials yielded an odds ratio for maintenance of remission of 1.36 (95% CI 0.87-2. 13). Removing the two studies that were published as abstracts did not significantly affect this result: the pooled odds ratio was 1.14 (95% CI 0.71-1.83). The two trials reported as abstracts were excluded from subgroup analyses because they did not include any information on adjunct therapy. Subgroup analysis of the two trials which used steroids to induce remission yielded an odds ratio for maintenance of remission of 3.37 (95% CI 1.38-8.24). The number needed to treat was three. However, these two trials included only 89 patients, and the results should be interpreted with caution. The remaining three trials compared the combination of anti-tuberculous therapy and 'standard therapy' with 'standard therapy alone'. The pooled odds ratio was 0.70 (95% CI 0.39-1.25). Anti-tuberculous therapy may be effective in maintaining remission in patients with Crohn's disease when remission has been induced with corticosteroids combined with anti-tuberculous therapy. However, the results which support this conclusion come from a subgroup of only two trials with small numbers of patients and should be interpreted with caution. Use of this therapy cannot be recommended on the basis of this evidence.
Gut, 2007
Background: Adalimumab induced clinical remission after four weeks in patients with active Crohn'... more Background: Adalimumab induced clinical remission after four weeks in patients with active Crohn's disease in the CLASSIC I trial.
Gastrointestinal Endoscopy, 2006
Cannulation of the common bile duct (CBD) is the first step in endoscopic retrograde cholangiopan... more Cannulation of the common bile duct (CBD) is the first step in endoscopic retrograde cholangiopancreatography (ERCP). Cannulation difficulty is a known risk factor for post-ERCP complications and may be minimized by the use of a smaller caliber sphincterotome. To compare the efficacy of CBD cannulation with a 4 F versus a 5 F sphincterotome. A randomized controlled trial, with concealed allocation and double-blinding. Adult patients undergoing their first ERCP at a tertiary referral center. Patients were randomized to undergo CBD cannulation with either a 4 F or 5 F sphincterotome. Successful deep cannulation in &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;15 attempts was the primary outcome. Secondary outcomes included number of attempts/time to cannulation, incidence of complications within 24 hours, and overall cannulation success (including patients before and after crossover). Analysis was intention to treat and included standard descriptive and inferential methods. A total of 107 patients were randomized: 51 (4 F) versus 56 (5 F). The majority were female (71%) and white (92%). Baseline demographics, presenting symptoms, and laboratory values were similar between groups. Similar success in initial cannulation was observed: 84.3% (4 F) and 83.9% (5 F). No differences were noted in time to cannulation (5.12 min [SD, 4.8] for 4 F vs 4.46 min [SD, 4.13] for 5 F; p = NS), number of attempts to cannulation (6.2 [SD, 5.2] for 4 F vs 5.7 [SD, 4.9] for 5 F; p = NS), or complications. The overall cannulation success was 92.2% (4 F) and 92.9% (5 F). Premature termination of the trial resulted in decreased power. There exists no significant difference in efficacy between 4 F and 5 F sphincterotomes. The choice of initial sphincterotome should be dictated by physician preference.
Gastroenterology, 2014
Methotrexate and infliximab are effective therapies for Crohn&amp;amp;amp;amp;amp;amp;amp... more Methotrexate and infliximab are effective therapies for Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease (CD). In the combination of maintenance methotrexate-infliximab trial, we evaluated the potential superiority of combination therapy over infliximab alone. In a 50-week, double-blind, placebo-controlled trial, we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15-40 mg/day) within the preceding 6 weeks. Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg, escalating to 25 mg/week (n = 63), or placebo (n = 63). Both groups received infliximab (5 mg/kg of body weight) at weeks 1, 3, 7, and 14, and every 8 weeks thereafter. Prednisone was tapered, beginning at week 1, and discontinued no later than week 14. The primary outcome was time to treatment failure, defined as a lack of prednisone-free remission (CD Activity Index, &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;150) at week 14 or failure to maintain remission through week 50. Patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; baseline characteristics were similar between groups. By week 50, the actuarial rate of treatment failure was 30.6% in the combination therapy group compared with 29.8% in the infliximab monotherapy group (P = .63; hazard ratio, 1.16; 95% confidence interval, 0.62-2.17). Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein. No clinically meaningful differences were observed in secondary outcomes. Combination therapy was well tolerated. The combination of infliximab and methotrexate, although safe, was no more effective than infliximab alone in patients with CD receiving treatment with prednisone. ClincialTrials.gov number, NCT00132899.
Gastroenterology, 2010
... S1051 Methotrexate for the Prevention of Antibodies to Infliximab in Patients With Crohn&... more ... S1051 Methotrexate for the Prevention of Antibodies to Infliximab in Patients With Crohn&#x27;s Disease. Brian G. Feagan ,; John W. McDonald ,; Remo Panaccione ,; Robert A. Enns ,; Charles N. Bernstein ,; Terry P. Ponich ,; Raymond Bourdages ,; Donald G. MacIntosh ,; ...
Gastroenterology, 2008
Background: The SEDASYS System (SS) is an investigational, computerassisted, personalized sedatio... more Background: The SEDASYS System (SS) is an investigational, computerassisted, personalized sedation system intended to provide endoscopist/nurse teams an "on-label" method to administer propofol sedation for colonoscopy and esophagogastroduodenoscopy (EGD) procedures. This institutional review board-approved study was designed to compare sedation with the SS to the current standard of care (CSC) with midazolam in combination with fentanyl or meperidine. Methods: One thousand subjects (496 SS; 504 CSC) were sedated for 731 colonoscopy and 279 EGDs at 8 sites. Electronic data were captured on a laptop computer. Subject responsiveness was assessed using a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. The primary endpoint was area under the curve (AUC) of oxygen desaturation (SpO 2 Ͻ 90%; ). Secondary endpoints were clinician satisfaction with sedation instrument, patient satisfaction with sedation instrument, time to recover from sedation (scope-out until return to MOAA/S ϭ 5) and duration of deep sedation/ general anesthesia (count of MOAA/S ϭ 1 or 0 during procedure). Results: One thousand subjects were randomized into the study. SS subjects received propofol (mean, 106.2 Ϯ 57.1 mg colonoscopy; 70.1 Ϯ 37.1 EGD) via a variable rate infusion and a single dose of fentanyl as a premedication (mean, 74.0 Ϯ 23.1 g colonoscopy; 65.6 Ϯ 22.4 EGD). CSC subjects received midazolam (8 sites; mean, 4.8 Ϯ 2.2 mg colonoscopy; 4.3 Ϯ 2.1 EGD) plus fentanyl (5 sites; mean, 98.3 Ϯ 31.1 g colonoscopy; 68.5 Ϯ 24.2 EGD) or meperidine (3 sites; mean, 43.9 Ϯ 15.8 mg colonoscopy; 42.3 Ϯ 15.5 EGD). summarizes the results for the primary and secondary endpoints. There were 34 adverse events, 0 serious adverse events, and 0 rescue interventions in the SS arm of the study, compared with 48, 1, and 1 in CSC. Conclusion: In this study physician/ nurse teams were able to safely and effectively administer propofol sedation with the SS during colonoscopy and EGD procedures. SS subjects had significantly lower AUC for oxygen desaturation compared with CSC subjects. Both physicians and subjects were more satisfied with the sedation achieved with the SS. SS subjects were minimally/moderately sedated, recovered quickly, and had minimal AEs.
Gastroenterology, 2006
Tumor necrosis factor blockade has been shown to be an effective treatment strategy in Crohn&... more Tumor necrosis factor blockade has been shown to be an effective treatment strategy in Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease (CD). Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor (TNF). A randomized, double-blind, placebo-controlled, dose-ranging trial was performed to evaluate the efficacy of adalimumab induction therapy in patients with CD. A total of 299 patients with moderate to severe CD naive to anti-TNF therapy were randomized to receive subcutaneous injections at weeks 0 and 2 with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg or placebo. The primary endpoint was demonstration of a significant difference in the rates of remission at week 4 (defined as a Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s Disease Activity Index score &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;150 points) among the 80 mg/40 mg, 160 mg/80 mg, and placebo groups. The rates of remission at week 4 in the adalimumab 40 mg/20 mg, 80 mg/40 mg, and 160 mg/80 mg groups were 18% (P = .36), 24% (P = .06), and 36% (P = .001), respectively, and 12% in the placebo group. Adverse events occurred at similar frequencies in all 4 treatment groups except injection site reactions, which were more common in adalimumab-treated patients. Adalimumab was superior to placebo for induction of remission in patients with moderate to severe Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease naive to anti-TNF therapy. The optimal induction dosing regimen for adalimumab in this study was 160 mg at week 0 followed by 80 mg at week 2. Adalimumab was well tolerated.
Background: This paper summarizes our experiences from a six-month pilot study of a web portal th... more Background: This paper summarizes our experiences from a six-month pilot study of a web portal that provided secure communications, education, and support for self-management by Inflammatory Bowel Disease (IBD) patients. An analysis of "don't know" responses revealed room for improvement in site organization and content analysis.
Gastroenterology, 2009
Background: Endoscopy units' delivery of timely service, consistent with published guidelines (Ca... more Background: Endoscopy units' delivery of timely service, consistent with published guidelines (Can J Gastro 2006;20:411) depends, partly, on efficient use of available resources. However, there is no mechanism to allow direct widespread monitoring of systemic quality indicators, such as booking appropriateness and bowel preparation adequacy in Canadian endoscopy units. Aim: To determine endoscopy unit quality indicators in the context of a national colonoscopy practice audit program. Methods: MDs at 13 centres collected data, in real time, on colonoscopies performed over periods of at least 2 weeks using data collection software (ReForm XT, Goanyware Software, Tulsa, OK) on a smartphone (Treo 650, Palm Inc, Mississauga, ON) with prompt download to a secure website and presentation on a secure website (ECD solutions, Atlanta, GA) for participants' review. Reasons for colonoscopy were classified as 'Investigation of abnormality' (INV), 'Screening' (SCR) and 'Surveillance' (SUR). Bowel preparation quality was rated with the Ottawa scale . Results : Since February 2008, 45 endoscopists (34 GIs & 11 surgeons) reported on 822 colonoscopies. Bowel preparation was: excellent: 73.9% and poor: 2.7%. The table shows the proportions of patients (a) colonoscoped at different intervals since their last colonoscopy and (b) in each age group at the time of colonoscopy. Summary: Colonoscopy intervals seem appropriate and most patients have good bowel preparation. However, for SCR patients, 20% are ≤50 yrs old, >10% have had a colonoscopy within <5 yrs and 8% are >70 yrs old. Conclusions: Point-of-care data collection on reasons for colonoscopy and bowel preparation quality facilitates: 1) practice audit by physicians and endoscopy units, and 2) improved resource utilization in the delivery of colonoscopy services. Percentages [95% CI] of patients with respect to interval since last colonoscopy and age '-' No patients in this group.