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1.  Disease manifestations of Helicobacter pylori infection in Arctic Canada: using epidemiology to address community concerns 
BMJ Open  2014;4(1):e003689.
Objectives
Helicobacter pylori infection, linked to gastric cancer, is responsible for a large worldwide disease burden. H pylori prevalence and gastric cancer rates are elevated among indigenous Arctic communities, but implementation of prevention strategies is hampered by insufficient information. Some communities in northern Canada have advocated for H pylori prevention research. As a first step, community-driven research was undertaken to describe the H pylori-associated disease burden in concerned communities.
Design
Participants in this cross-sectional study completed a clinical interview and gastroscopy with gastric biopsies taken for histopathological examination in February 2008.
Setting
Study procedures were carried out at the health centre in Aklavik, Northwest Territories, Canada (population ∼600).
Participants
All residents of Aklavik were invited to complete a clinical interview and gastroscopy; 194 (58% female participants; 91% Aboriginal; age range 10–80 years) completed gastroscopy and had gastric biopsies taken.
Primary and secondary outcome measures
This analysis estimates the prevalence of gastric abnormalities detected by endoscopy and histopathology, and associations of demographic and clinical variables with H pylori prevalence.
Results
Among 194 participants with evaluable gastric biopsies, 66% were H pylori-positive on histology. Among H pylori-positive participants, prevalence was 94% for acute gastritis, 100% for chronic gastritis, 21% for gastric atrophy and 11% for intestinal metaplasia of the gastric mucosa, while chronic inflammation severity was mild in 9%, moderate in 47% and severe in 43%. In a multivariable model, H pylori prevalence was inversely associated with previous gastroscopy, previous H pylori therapy and aspirin use, and was positively associated with alcohol consumption.
Conclusions
In this population, H pylori-associated gastric histopathology shows a pattern compatible with elevated risk of gastric cancer. These findings demonstrate that local concern about health risks from H pylori is warranted and provide an example of how epidemiological research can address health priorities identified by communities.
doi:10.1136/bmjopen-2013-003689
PMCID: PMC3902307  PMID: 24401722
2.  Upper-gastrointestinal bleeding secondary to peptic ulcer disease: Incidence and outcomes 
World Journal of Gastroenterology : WJG  2014;20(46):17568-17577.
AIM: To evaluate the incidence, surgery, mortality, and readmission of upper gastrointestinal bleeding (UGIB) secondary to peptic ulcer disease (PUD).
METHODS: Administrative databases identified all hospitalizations for UGIB secondary to PUD in Alberta, Canada from 2004 to 2010 (n = 7079) using the International Classification of Diseases Codes (ICD-10). A subset of the data was validated using endoscopy reports. Positive predictive value and sensitivity with 95% confidence intervals (CI) were calculated. Incidence of UGIB secondary to PUD was calculated. Logistic regression was used to evaluate surgery, in-hospital mortality, and 30-d readmission to hospital with recurrent UGIB secondary to PUD. Co-variants accounted for in our logistic regression model included: age, sex, area of residence (i.e., urban vs rural), number of Charlson comorbidities, presence of perforated PUD, undergoing upper endoscopy, year of admission, and interventional radiological attempt at controlling bleeding. A subgroup analysis (n = 6356) compared outcomes of patients with gastric ulcers to those with duodenal ulcers. Adjusted estimates are presented as odds ratios (OR) with 95%CI.
RESULTS: The positive predictive value and sensitivity of ICD-10 coding for UGIB secondary to PUD were 85.2% (95%CI: 80.2%-90.2%) and 77.1% (95%CI: 69.1%-85.2%), respectively. The annual incidence between 2004 and 2010 ranged from 35.4 to 41.2 per 100000. Overall risk of surgery, in-hospital mortality, and 30-d readmission to hospital for UGIB secondary to PUD were 4.3%, 8.5%, and 4.7%, respectively. Interventional radiology to control bleeding was performed in 0.6% of patients and 76% of these patients avoided surgical intervention. Thirty-day readmission significantly increased from 3.1% in 2004 to 5.2% in 2010 (OR = 1.07; 95%CI: 1.01-1.14). Rural residents (OR rural vs urban: 2.35; 95%CI: 1.83-3.01) and older individuals (OR ≥ 65 vs < 65: 1.57; 95%CI: 1.21-2.04) were at higher odds of being readmitted to hospital. Patients with duodenal ulcers had higher odds of dying (OR = 1.27; 95%CI: 1.05-1.53), requiring surgery (OR = 1.73; 95%CI: 1.34-2.23), and being readmitted to hospital (OR = 1.54; 95%CI: 1.19-1.99) when compared to gastric ulcers.
CONCLUSION: UGIB secondary to PUD, particularly duodenal ulcers, was associated with significant morbidity and mortality. Early readmissions increased over time and occurred more commonly in rural areas.
doi:10.3748/wjg.v20.i46.17568
PMCID: PMC4265619  PMID: 25516672
Epidemiology; Peptic ulcer hemorrhage; Digestive system surgical procedures; Mortality; Endoscopy; Validation studies; Incidence
3.  A randomized controlled trial comparing sequential with triple therapy for Helicobacter pylori in an Aboriginal community in the Canadian North 
BACKGROUND:
Helicobacter pylori infection occurs more frequently in Arctic Aboriginal settings than elsewhere in North America and Europe. Research aimed at reducing health risks from H pylori infection has been conducted in the Aboriginal community of Aklavik, Northwest Territories.
OBJECTIVE:
To compare the effectiveness of the Canadian standard therapy with an alternative therapy for eliminating H pylori infection in Aklavik.
METHODS:
Treatment-naive H pylori-positive individuals were randomly assigned to a 10-day regimen (oral twice-daily doses) with rabeprazole (20 mg): standard triple therapy (proton pump inhibitor, added clarithromycin [500 mg] and amoxicillin [1 g] [PPI-CA]); sequential therapy (ST) added amoxicillin (1 g) on days 1 to 5, and metronidazole (500 mg) and clarithromycin (500 mg) on days 6 to 10. Participants with clarithromycin-resistant H pylori were randomly assigned to ST or quadruple therapy. Treatment effectiveness was estimated as per cent (95% CI) with a negative urea breath test at least 10 weeks after treatment.
RESULTS:
Of 104 (53 PPI-CA, 51 ST) randomized participants, 89 (49 PPI-CA, 40 ST) had post-treatment results. Per-protocol treatment effectiveness was 59% (95% CI 45% to 73%) for PPI-CA and 73% (95% CI 58% to 87%) for ST. Based on intention to treat, effectiveness was 55% (95% CI 41% to 69%) for PPI-CA and 57% (95% CI 43% to 71%) for ST. Of 77 participants (43 PPI-CA, 34 ST) with 100% adherence, effectiveness was 63% (95% CI 43% to 82%) for PPI-CA and 81% (95% CI 63% to 99%) for ST.
CONCLUSIONS:
While additional evidence is needed to confirm that ST is more effective for Arctic Aboriginal communities than the Canadian standard H pylori treatment, these results show standard PPI-CA treatment to be inadequate for communities such as Aklavik.
PMCID: PMC3915012  PMID: 24340314
Aboriginal health; Arctic, Canada; Community-based participatory research; Helicobacter pylori; Randomized controlled trial
4.  Improving access in gastroenterology: The single point of entry model for referrals 
In 2005, a group of academic gastroenterologists in Calgary (Alberta) adopted a centralized referral intake system known as central triage. This system provided a single point of entry model (SEM) for referrals rather than the traditional system of individual practitioners managing their own referrals and queues. The goal of central triage was to improve wait times and referral management. In 2008, a similar system was developed in Edmonton at the University of Alberta Hospital (Edmonton, Alberta). SEMs have subsequently been adopted by numerous subspecialties throughout Alberta. There are many benefits of SEMs including improved access and reduced wait times. Understanding and measuring complex patient flow systems is key to improving access, and centralized intake systems provide an opportunity to better understand total demand and system bottlenecks. This knowledge is particularly important for specialties such as gastroenterology (GI), in which demand exceeds supply. While it is anticipated that SEMs will reduce wait times for GI care in Canada, the lack of sufficient resources to meet the demand for GI care necessitates additional strategies.
PMCID: PMC3816943  PMID: 24040629
Access; Central triage; Single point of entry model; Wait times
5.  Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT) 
Trials  2014;15:72.
Background
Stress, depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of prenatal care providers assess and treat mental health problems and fewer than 20% of pregnant women seek mental healthcare. For those who seek treatment, the lack of health system integration and existing barriers frequently prevent treatment access. Without treatment, poor prenatal mental health can persist for years and impact future maternal, child, and family well-being.
Methods/Design
The purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment, referral, and cognitive behavior therapy (CBT) for pregnant women compared to usual prenatal care (no formal screening or specialized care). The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks postrandomization. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. Pregnant women are eligible if they: 1) are <28 weeks gestation; 2) speak/read English; 3) are willing to complete email questionnaires; 4) have no, low, or moderate psychosocial risk on screening at recruitment; and 5) are eligible for CBT. A sample of 816 women will be recruited from large, urban primary care clinics and allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment, and those with mild or moderate depression, anxiety, or stress symptoms then complete six interactive cognitive behavior therapy modules. All women will complete email questionnaires at 6 to 8 weeks postrandomization and at 3, 6, and 12 months postpartum. Clinic-based providers and researchers conducting chart abstraction and analysis are blinded. Qualitative interviews with 8 to 10 healthcare providers and 15 to 30 intervention group women will provide data on feasibility and acceptability of the intervention. Results of this trial will determine the feasibility and effectiveness of an integrated approach to prenatal mental healthcare and the use of highly accessible computer-based psychosocial assessment and CBT on maternal, infant, and family-based outcomes.
Trial registration
ClinicalTrials.gov Identifier: NCT01901796
doi:10.1186/1745-6215-15-72
PMCID: PMC4015853  PMID: 24597683
psychosocial assessment; online; screening; cognitive behavior therapy; pregnancy; depression; anxiety; stress; randomized controlled trial
6.  The endoscopy Global Rating Scale – Canada: Development and implementation of a quality improvement tool 
BACKGROUND:
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.
OBJECTIVE:
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.
METHODS:
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).
RESULTS:
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 to 12 statements that are divided into levels graded D (basic) through A (advanced). A core team consisting of a booking clerk, charge nurse and the physician responsible for the unit is recommended to complete the GRS-C twice yearly.
CONCLUSION:
The GRS-C is intended to improve endoscopic services in Canada by providing endoscopy units with a straightforward process to review the quality of the service they provide.
PMCID: PMC3731117  PMID: 23472242
Endoscopy; Global rating scale; GRS; Quality
7.  Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial 
Trials  2014;15:3.
Background
Stress, depression, and anxiety affect 15% to 25% of pregnant women. However, substantial barriers to psychosocial assessment exist, resulting in less than 20% of prenatal care providers assessing and treating mental health problems. Moreover, pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider. Identifying screening and assessment tools and procedures that are acceptable to both women and service providers, cost-effective, and clinically useful is needed.
Methods/Design
The primary objective of this randomized, parallel-group, superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment (e-screening) compared to paper-based screening. Secondary objectives are to compare the two modes of screening on: (1) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk; (2) the level of disclosure of symptoms; (3) the factors associated with feasibility, acceptability, and disclosure; (4) the psychometric properties of the e-version of the assessment tools; and (5) cost-effectiveness. A sample of 542 women will be recruited from large, primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city. Pregnant women are eligible to participate if they: (1) receive care at one of the recruitment sites; (2) are able to speak/read English; (3) are willing to be randomized to e-screening; and (4) are willing to participate in a follow-up diagnostic interview within 1 week of recruitment. Allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment on a computer tablet, while those in the control group will complete the same assessment in paper-based form. All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within 1 week of recruitment. Research assistants conducting diagnostic interviews and physicians will be blinded. A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention. We hypothesize that mental health e-screening in primary care maternity settings and high-risk antenatal units will be as or more feasible, acceptable, and capable of detecting depression, anxiety, and psychosocial risk compared to paper-based screening.
Trial registration
ClinicalTrials.gov Identifier: NCT01899534.
doi:10.1186/1745-6215-15-3
PMCID: PMC3892094  PMID: 24383441
Psychosocial assessment; Online; Screening; Pregnancy; Depression; Anxiety; Stress; Randomized controlled trial
8.  Patient satisfaction with medication for gastroesophageal reflux disease: A systematic review 
BACKGROUND:
Patient satisfaction is increasingly regarded as an important aspect of measuring treatment success in individuals with gastroesophageal reflux disease (GERD).
OBJECTIVE:
To review how satisfied patients with GERD are with their medication, and to analyze the usefulness of patient satisfaction as a clinical end point by comparing it with symptom improvement.
METHODS:
Systematic searches of the PubMed and EMBASE databases identified clinical trials and patient surveys published between 1966 and 2009.
RESULTS:
Twelve trials reported that 56% to 100% of patients were ‘satisfied’ or ‘very satisfied’ with proton pump inhibitor (PPI) treatment for GERD. Patient satisfaction levels were higher for PPIs than other GERD medications in two trials. The sample-size-weighted average proportion of patients ‘satisfied’ with their PPI after four weeks of treatment in trials was 93% (95% CI 87% to 99%), with 73% (95% CI 62% to 83%) being ‘very satisfied’. In four surveys, the average proportion of patients ‘satisfied’ with their PPI treatment was 82% (95% CI 73% to 90%) and 62% (95% CI 48% to 75%) were ‘very satisfied’. Seven trials found a positive association between patient satisfaction and symptom improvement, and two surveys between satisfaction and improved health-related quality of life. Three trials found that continuous treatment yielded higher rates of satisfaction than on-demand therapy.
CONCLUSIONS:
More than one-half of patients were satisfied with their PPI medication in trials, and more patients were satisfied with PPIs than other medication types. An association between patient satisfaction and symptom resolution was found, suggesting that patient satisfaction is a useful end point for evaluating GERD treatment success.
PMCID: PMC3354888  PMID: 22506259
GERD; Medication; Patient-reported outcome; Satisfaction; Therapy
9.  Adherence and barriers to H. pylori treatment in Arctic Canada 
International Journal of Circumpolar Health  2013;72:10.3402/ijch.v72i0.22791.
Introduction
Helicobacter pylori infection is an emerging health concern to some northern Canadian Aboriginal communities and their clinicians. Clinicians in the north perceive H. pylori infection to be a major clinical problem because they find H. pylori infection in many patients evaluated for common stomach complaints, leading to frequent demand for treatment, which often fails. Moreover, public health authorities identified the need for information to develop locally appropriate H. pylori control strategies. We described adherence and identified barriers to completing treatment among H. pylori-positive participants in a community-based project inspired by local concerns about H. pylori infection risks.
Methods
In 2008, 110 H. pylori-positive participants (diagnosed by a breath test, histopathology and/or culture) of the Aklavik H. pylori project were randomised to standard-of-care or sequential treatment. We ascertained adherence by interviewing participants using a structured questionnaire. We estimated adherence frequencies as the proportion of participants who reported taking either 100% of doses (perfect adherence) or ≥80% of doses (good adherence). To compare the proportion with perfect or good adherence in subgroups, we report proportion differences and 95% confidence intervals (CI).
Results
Of 87 participants who were interviewed, 64% reported perfect adherence and 80% reported good adherence. We observed more frequent perfect adherence for: standard therapy (67%) versus sequential (62%); males (76%) versus females (52%); participants 40–77 years (79%) versus 17–39 (50%). Proportion differences were 5% (CI: −15, 25) for standard versus sequential therapy; 23% (CI: 4, 43) for male versus female; and 29% (CI: 10, 48) for 40–77 versus 15–39 years for perfect adherence. Of the 29 participants who reported poor adherence (<80% of doses taken), the following barriers to treatment were reported: changed mind about taking treatment (24%), consumption of alcoholic beverages (18%), nausea (18%), forgetfulness (12%), stomach pain (12%), difficulty in swallowing pills (6%), no reason (6%) or bad taste of the pills (6%).
Conclusion
This analysis suggests that adherence to treatment for eliminating H. pyori infection may vary by regimen and may be influenced by socio-demographic factors. These findings add to the small body of evidence pertaining to adherence to H. pylori treatment in Arctic Aboriginal communities. On-going research in additional northern Canadian communities will accumulate data for developing recommendations to improve adherence for treatment to eliminate H. pylori infection.
doi:10.3402/ijch.v72i0.22791
PMCID: PMC3887371  PMID: 24416723
Aboriginal health; Helicobacter pylori; peptic ulcers; cancer; circumpolar regions
10.  A randomized controlled trial of four precolonoscopy bowel cleansing regimens 
Incomplete or inadequate bowel cleansing continues to hamper successful colonoscopy, and frustrate physicians and patients. Although several bowel preparations initially demonstrated promising results, side effects and factors affecting compliance led to their diminishing and, in some cases, complete withdrawal from use. Only a small number of studies examining the use of newer regimens and agents have been reported; although safe and well tolerated, however, their efficacy remains unclear. This study investigated cleansing efficacy, patient tolerability and the safety of different regimens and combinations of cleansing agents in colonoscopies performed in the morning versus the afternoon.
BACKGROUND:
The ideal bowel cleansing regimen for colonoscopy has yet to be determined.
OBJECTIVE:
To compare the cleansing efficacy, and patient tolerability and safety of four bowel preparation regimens.
METHODS:
A total of 834 patients undergoing outpatient colonoscopy were randomly assigned to one of four regimens: 4 L polyethylene glycol (PEG); 2 L PEG + 20 mg bisacodyl; 90 mL of sodium phosphate (NaP); or two sachets of a commercially available bowel cleansing solution (PSMC) + 300 mL of magnesium citrate (M). The primary outcome measure was cleansing efficacy, which was scored by blinded endoscopists using the Ottawa Bowel Preparation Scale. Secondary outcome measures were bowel preparation quality according to time of colonoscopy, and patient tolerability and safety.
RESULTS:
The mean total cleansing score was significantly worse in the NaP group compared with the other three groups (P<0.0001). The mean cleansing scores were worse in patients who underwent morning versus afternoon colonoscopy, a finding that was consistent in all four groups. PSMC + M was the best tolerated regimen. No clinically significant mean changes in creatinine or electrolyte levels were identified, although a significantly higher proportion of patients in the NaP group developed hypokelemia (P<0.0001).
CONCLUSIONS:
2 L PEG + 20 mg bisacodyl, or PSMC + M was as efficacious as 4 L PEG and superior to NaP for bowel cleansing. A short interval between the completion of bowel preparation and the start of colonoscopy (ie, ‘runway time’), irrespective of bowel preparation regimen, appeared to be a more important predictor of bowel cleanliness than the cathartic agents used.
PMCID: PMC3266156  PMID: 22175055
Bowel preparation; Colonoscopy
11.  The rate of prescribing gastrointestinal prophylaxis with either a proton pump inhibitor or an H2-receptor antagonist in Nova Scotia seniors starting nonsteroidal anti-inflammatory drug therapy 
BACKGROUND:
Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used agents that can cause serious gastrointestinal (GI) side effects. For patients at increased risk of NSAID-related GI complications, prophylaxis with either a nonselective NSAID plus gastroprotective agent (GPA) or, alternatively, therapy with a cyclooxygenase-2 selective inhibitor with or without a GPA such as a proton pump inhibitor (PPI), is recommended.
AIM:
To describe the rate, timing and duration of GI prophylaxis in Nova Scotia seniors receiving nonselective NSAIDs.
METHODS:
The Nova Scotia Seniors’ Pharmacare Program beneficiaries for the years 1998 to 2002 were studied. A cohort of incident NSAID and GPA users was selected from all nonselective NSAID users (no prescribed NSAID dispensed 12 months before the index month and no GPA dispensed two months before the index prescription). Monthly coprescribing rates were calculated by dividing the number of patients in the cohort using GPAs by the number of NSAID users. GI prophylactic coprescribing was defined as the coprescribing rate present at the first month (index month) of prescribing an NSAID.
RESULTS:
The cohort consisted of 12,906 patients. Seventy-five per cent of the nonselective NSAID prescriptions dispensed were for up to two months duration, with only 2.3% longer than one year. GI prophylaxis was given to only 3.8% of patients starting NSAIDs who were not on a GPA in the two months before starting NSAIDs. Of this 3.8%, 92.7% of the patients received H2-receptor antagonists (H2RAs), and 7% received PPIs. The rate of H2RA coprescribing increased with the number of consecutive months on an NSAID from 3.5% in the first month to 24.1% at 48 months. For PPIs, the coprescribing rate increased from 0.3% to 1.9% of all NSAID users in the cohort. The rate of gastroprophylaxis coprescribing for patients receiving NSAIDs did not rise with increasing age.
CONCLUSION:
In Nova Scotian seniors using nonselective NSAIDs, the rate of GI prophylaxis was low. Most patients received H2RAs as GPAs despite evidence that they offer insufficient protection.
PMCID: PMC2947001  PMID: 20711527
Cohort study; Cyclooxygenase-2 selective inhibitor; Drug utilization; Gastrointestinal prophylaxis; Histamine-2 receptor antagonist; Misoprostol; Nonsteroidal anti-inflammatory drugs; NSAIDs; Proton pump inhibitor; Prescribing; Seniors
12.  A one-year economic evaluation of six alternative strategies for the management of uninvestigated upper gastrointestinal symptoms in Canadian primary care 
BACKGROUND:
The cost-effectiveness of initial strategies in managing Canadian patients with uninvestigated upper gastrointestinal symptoms remains controversial.
OBJECTIVE:
To assess the cost-effectiveness of six management approaches to uninvestigated upper gastrointestinal symptoms in the Canadian setting.
METHODS:
The present study analyzed data from four randomized trials assessing homogeneous and complementary populations of Canadian patients with uninvestigated upper gastrointestinal symptoms with comparable outcomes. Symptom-free months, quality-adjusted life-years (QALYs) and direct costs in Canadian dollars of two management approaches based on the Canadian Dyspepsia Working Group (CanDys) Clinical Management Tool, and four additional strategies (two empirical antisecretory agents, and two prompt endoscopy) were examined and compared. Prevalence data, probabilities, utilities and costs were included in a Markov model, while sensitivity analysis used Monte Carlo simulations. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were determined.
RESULTS:
Empirical omeprazole cost $226 per QALY ($49 per symptom-free month) per patient. CanDys omeprazole and endoscopy approaches were more effective than empirical omeprazole, but more costly. Alternatives using H2-receptor antagonists were less effective than those using a proton pump inhibitor. No significant differences were found for most incremental cost-effectiveness ratios. As willingness to pay (WTP) thresholds rose from $226 to $24,000 per QALY, empirical antisecretory approaches were less likely to be the most cost-effective choice, with CanDys omeprazole progressively becoming a more likely option. For WTP values ranging from $24,000 to $70,000 per QALY, the most clinically relevant range, CanDys omeprazole was the most cost-effective strategy (32% to 46% of the time), with prompt endoscopy-proton pump inhibitor favoured at higher WTP values.
CONCLUSIONS:
Although no strategy was the indisputable cost-effective option, CanDys omeprazole may be the strategy of choice over a clinically relevant range of WTP assumptions in the initial management of Canadian patients with uninvestigated dyspepsia.
PMCID: PMC2947002  PMID: 20711528
Antisecretory therapy; Cost-effectiveness; Dyspepsia; Economic modelling; Endoscopy; Helicobacter pylori
13.  Canadian Digestive Health Foundation Public Impact Series: Gastroesophageal reflux disease in Canada: Incidence, prevalence, and direct and indirect economic impact 
The Canadian Digestive Health Foundation initiated a scientific program to assess the incidence, prevalence, mortality and economic impact of digestive disorders across Canada. The current article presents the updated findings from the study concerning gastroesophageal reflux disease – a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications (Montreal definition).
PMCID: PMC2918483  PMID: 20652158
Acid reflux; Chronic disease; Gastroesophageal reflux disease; GERD; Heartburn; Pyrosis
14.  Rescue therapy using a rifabutin-based regimen is effective for cure of Helicobacter pylori infection 
OBJECTIVE:
To evaluate the efficacy of rescue therapy using rifabutin, amoxicillin and a proton pump inhibitor (PPI) in the eradication of Helicobacter pylori in patients who have failed at least one course of PPI-based triple therapy.
METHODS:
The present study was a single-centre case series of 16 consecutive patients who had received at least one course of standard eradication therapy. Pretreatment evaluation included endoscopy with biopsies for histology and culture for H pylori infection. Treatment consisted of a one-week regimen containing a PPI twice daily, amoxicillin (A) 1 g twice daily and rifabutin (R) 300 mg once daily (PPI-AR). Post-treatment evaluation consisted of a repeat endoscopy with biopsy for histology and culture, or a validated urea breath test at least four weeks after treatment was completed. Pretreatment antibiotic susceptibility to metronidazole, clarithromycin and A was evaluated using a validated epsilometer test.
RESULTS:
Of the 16 patients, four had previously received one course of triple therapy, 10 had received two courses and two had received more than two courses. The overall success rate of PPI-AR was 63% (10 of 16). Resistance to A was 0% (0 of 13), metronidazole 77% (10 of 13), clarithromycin 70% (seven of 10), and both metronidazole and clarithromycin 60% (six of 10). There was no correlation between resistance patterns and cure rate.
CONCLUSIONS:
An R-containing regimen such as PPI-AR is a viable option as rescue therapy for H pylori infection.
PMCID: PMC2886571  PMID: 20485704
Amoxicillin; Antibiotic resistance; Clarithromycin; Eradication rate; Helicobacter pylori; Metronidazole; Proton pump inhibitor; Rifabutin; Treatment
15.  A randomized trial of topical anesthesia comparing lidocaine versus lidocaine plus xylometazoline for unsedated transnasal upper gastrointestinal endoscopy 
BACKGROUND:
The optimal topical anesthesia regimen for unsedated transnasal endoscopy is unknown. The addition of a nasal decongestant, such as xylometazoline (X), to a topical anesthestic may improve patient comfort.
OBJECTIVE:
To determine the effectiveness of lidocaine (L) versus L plus X (LX) for anesthesia in unsedated transnasal endoscopy.
METHODS:
Consecutive participants of the Aklavik Helicobacter pylori project were prospectively randomly assigned to receive LX or L for unsedated transnasal 4.9 mm ultrathin endoscopy. The primary outcome was overall procedure discomfort on a validated 10-point visual analogue scale (1 = no discomfort, 10 = severe discomfort). Secondary outcomes included pain, endoscope insertion difficulty, gagging, adverse events and encounter times. Results were presented as mean ± SD, difference in mean, 95% CI.
RESULTS:
A total of 181 patients were randomly assigned to receive LX (n=94) and L (n=87). Baseline characteristics between the two groups were similar (mean age 40 years, 59% women). Overall, patient procedural discomfort with LX and L were 4.2±2.4 versus 3.9±2.1, respectively (0.29; 95% CI −0.39 to 0.96). Transnasal insertion difficulty was significantly lower with LX than with L (2.4±2.1 versus 3.2±2.8, respectively [−0.80; 95% CI −1.54 to −0.06]). Compared with L, the use of LX was associated with significantly less time needed to apply anesthesia (2.4±1.8 min versus 3.5±2.2 min, respectively [−1.10; 95% CI −1.71 min to −0.50 min]) and less time for insertion (3.2±1.8 min versus 3.9±2.2 min, respectively [−0.70 min; 95% CI −1.30 min to −0.10 min]). Epistaxis was rare but occurred less frequently with LX (1.1%) than with L (4.6%) (P=0.19).
CONCLUSIONS:
LX did not improve patient comfort for transnasal endoscopy compared with L alone. However, LX was associated with less difficulty with endoscope transnasal insertion and reduced insertion time. Further studies on the optimal regimen and dosing of anesthesia are required.
PMCID: PMC2886574  PMID: 20485707
Topical anesthesia; Transnasal endoscopy; Ultrathin
16.  Pancreatic cancer in Canada: Incidence and mortality trends from 1992 to 2005 
Background
Pancreatic cancer is the fourth-ranking cause of death among all major malignancies in Canada and has the lowest five-year survival rate.
Aim
To examine incidence and mortality trends of pancreatic cancer in Canada from 1992 to 2005, with particular emphasis on the role of cigarette smoking.
Methods
Data from Health Canada and Statistics Canada were analyzed for age-adjusted incidence and mortality trends from 1992 to 2005. The future burden of pancreatic cancer in Canada was based on population projections.
Results
The incidence rate of pancreatic cancer for women between 1992 and 2005 remained stable (8.49 and 8.48 cases per 100,000, respectively), and there was a decrease in the incidence for men from 11.1 per 100,000 in 1992 to 9.89 per 100,000 in 2005. This reduction may be the result of a decrease in smoking rates among Canadian men. The mortality rate of this cancer remains high. Approximately 99% of all pancreatic cancer cases occur in individuals older than 50 years of age. The total number of annual cases of pancreatic cancer in Canada is expected to more than double from 2636 cases in 2006 to 5619 in the year 2031.
Conclusion
The incidence of pancreatic cancer in Canada from 1992 to 2005 remained relatively stable, although the incidence decreased somewhat in men, perhaps as a result of a change in smoking behaviour. The total number of cases of pancreatic cancer is expected to more than double by 2031.
PMCID: PMC2732175  PMID: 19668798
Incidence; Mortality; Pancreatic neoplasm; Trends
17.  Early experience with unsedated ultrathin 4.9 mm transnasal gastroscopy: A pilot study 
BACKGROUND:
Unsedated transnasal gastroscopy is a technique with unverified clinical advantages.
OBJECTIVE:
To evaluate the efficacy and procedure times with transnasal gastroscopy by physicians with no previous experience in transnasal endoscopy.
METHODS:
Unsedated transnasal gastroscopy using 4.9 mm ultrathin transnasal gastroscopes with randomization to two different biopsy forceps was prospectively evaluated during a single day in January 2008. The outcomes included patient tolerance (scale: 1, no discomfort; 10, severe discomfort), physician technical assessment (1, excellent; 10, very poor), gastric biopsy quality, adverse events and procedure times.
RESULTS:
Twenty patients underwent transnasal gastroscopy. Nineteen patients (95%) successfully completed transnasal gastroscopy. The patient-reported mean (± SD) overall discomfort level during the procedure was 4.0±1.9 compared with a physician-estimated level of 3.2±1.7 (P=0.04). Only 10% (n=2) reported they would have preferred sedated over unsedated gastroscopy. Mean total encounter time from anesthesia to discharge was 33.5±9.3 min. The time from anesthesia to insertion was 7.0±5.3 min and from room exit to discharge 6.2±2.9 min. No patients who had gastric biopsies taken (zero of 14) had any of unacceptable quality. The only adverse event was distressing sensations (dyspnea, dizziness) in one patient that started during pre-endoscopy anesthetic application, persisting postendoscopy, but without any abnormalities in vital signs.
CONCLUSION:
Assuming the adverse event was a rare reaction, early experience with unsedated ultrathin transnasal gastroscopy was an efficient, effective and well-tolerated procedure for evaluation of the upper gastrointestinal tract.
PMCID: PMC2661194  PMID: 19018337
Endoscopy; Transnasal; Ultrathin; Unsedated
18.  Helicobacter pylori infection in Canada’s arctic: Searching for the solutions 
The Canadian North Helicobacter pylori (CANHelp) working group is a team composed of investigators, health officials and community leaders from Alberta and the Northwest Territories. The group’s initial goals are to investigate the impact of H pylori infection on Canada’s Arctic communities; subsequent goals include identifying treatment strategies that are effective in this region and developing recommendations for health policy aimed at management of H pylori infection. The team’s investigations have begun with the Aklavik H pylori Project in the Aboriginal community of Aklavik, Northwest Territories.
PMCID: PMC2661193  PMID: 19018336
Endoscopy; First Nations; Gastric cancer; Gastritis; Helicobacter pylori
19.  Helicobacter pylori infection in Canadian and related Arctic Aboriginal populations 
In 2006, the Canadian Helicobacter Study Group identified Aboriginal communities among Canadian population groups most at risk of Helicobacter pylori-associated disease. The objective of this systematic review was to summarize what is known about the H pylori-associated disease burden in Canadian and related Arctic Aboriginal populations to identify gaps in knowledge. Six health literature databases were systematically searched to identify reports on H pylori prevalence in Canadian population groups, or any topic related to H pylori in Canadian Aboriginals, Alaska Natives or Aboriginals of other Arctic regions. Identified reports were organized by subtopic and summarized in narrative form. Key data from studies of H pylori prevalence in defined populations were summarized in tabular form. A few Arctic Aboriginal communities were represented in the literature: two Canadian Inuit; one Canadian First Nation; two Greenland Inuit; one Russian Chutkotka Native; and several Alaska Native studies. These studies uniformly showed elevated H pylori prevalence; a few studies also showed elevated occurrence of H pylori-related diseases and high rates of treatment failure. Based on the evidence, it would be warranted for clinicians to relax the criteria for investigating H pylori and related diseases in patients from Arctic Aboriginal communities, and to pursue post-therapy confirmation of eradication. Additional community-based research is needed to develop public health policies for reducing H pylori-associated health risks in such communities.
PMCID: PMC2662204  PMID: 18354758
Arctic regions; Helicobacter pylori; Inuits; North American Indians; Prevalence; Systematic review
20.  A meta-analysis of the success rate of Helicobacter pylori therapy in Canada 
BACKGROUND AND AIM:
Helicobacter pylori treatment success rates have varied. A systematic review of the success rate of anti-H pylori therapy in Canada was performed.
METHODS:
All clinical trials containing Canadian data on the success rate of H pylori treatment were identified using MEDLINE searches, through review of references of retrieved studies and by contacting key investigators. Both randomized and open-label trials were included. Treatment effect size was calculated using a variation of Cochran’s Q method.
RESULTS:
Seventeen papers met the inclusion criteria. Both triple therapies consisting of a proton pump inhibitor (PPI), clarithromycin and either amoxicillin or metronidazole performed well, achieving a success rate of 84% and 82%, respectively. The cure rate of PPI-amoxicillin + metronidazole was 76%. Quadruple therapy consisting of a PPI, bismuth, metronidazole and tetracycline, given for seven to 10 days, achieved a success rate of 87%.
CONCLUSION:
Both PPI-based triple therapy and quadruple therapy perform well in Canada for the treatment of H pylori infection.
PMCID: PMC2657711  PMID: 17505565
Amoxicillin; Bismuth; Canada; Clarithromycin; Eradication; Helicobacter pylori; Meta-analysis; Metronidazole; Proton pump inhibitors; RCT; Treatment
21.  The impact of illness in patients with moderate to severe gastro-esophageal reflux disease 
BMC Gastroenterology  2005;5:23.
Background
Gastro-esophageal reflux disease (GERD) is a common disease. It impairs health related quality of life (HRQL). However, the impact on utility scores and work productivity in patients with moderate to severe GERD is not well known.
Methods
We analyzed data from 217 patients with moderate to severe GERD (mean age 50, SD 13.7) across 17 Canadian centers. Patients completed three utility instruments – the standard gamble (SG), the feeling thermometer (FT), and the Health Utilities Index 3 (HUI 3) – and several HRQL instruments, including Quality of Life in Reflux and Dyspepsia (QOLRAD) and the Medical Outcomes Short Form-36 (SF-36). All patients received a proton pump inhibitor, esomeprazole 40 mg daily, for four to six weeks.
Results
The mean scores on a scale from 0 (dead) to 1 (full health) obtained for the FT, SG, and HUI 3 were 0.67 (95% CI, 0.64 to 0.70), 0.76 (95% CI, 0.75 to 0.80), and 0.80 (95% CI, 0.77 to 0.82) respectively. The mean scores on the SF-36 were lower than the previously reported Canadian and US general population mean scores and work productivity was impaired.
Conclusion
GERD has significant impact on utility scores, HRQL, and work productivity in patients with moderate to severe disease. Furthermore, the FT and HUI 3 provide more valid measurements of HRQL in GERD than the SG. After treatment with esomeprazole, patients showed improved HRQL.
doi:10.1186/1471-230X-5-23
PMCID: PMC1183201  PMID: 16004616
22.  The influence of demographic factors and health-related quality of life on treatment satisfaction in patients with gastroesophageal reflux disease treated with esomeprazole 
Background
The correlation between treatment satisfaction and demographic characteristics, symptoms, or health-related quality of life (HRQL) in patients with gastroesophageal reflux disease (GERD) is unknown. The objective of this study was to assess correlates of treatment satisfaction in patients with GERD receiving a proton pump inhibitor, esomeprazole.
Methods
Adult GERD patients (n = 217) completed demography, symptom, HRQL, and treatment satisfaction questionnaires at baseline and/or after treatment with esomeprazole 40 mg once daily for 4 weeks. We used multiple linear regressions with treatment satisfaction as the dependent variable and demographic characteristics, baseline symptoms, baseline HRQL, and change scores in HRQL as independent variables.
Results
Among the demographic variables only Caucasian ethnicity was positively associated with treatment satisfaction. Greater vitality assessed by the Quality of Life in Reflux and Dyspepsia (QOLRAD) and worse heartburn assessed by a four-symptom scale at baseline, were associated with greater treatment satisfaction. The greater the improvement on the QOLRAD vitality (change score), the more likely the patient is to be satisfied with the treatment.
Conclusions
Ethnicity, baseline vitality, baseline heartburn severity, and change in QOLRAD vitality correlate with treatment satisfaction in patients with GERD.
doi:10.1186/1477-7525-3-4
PMCID: PMC545938  PMID: 15649314
Demography; esomeprazole; Feeling Thermometer; GERD; QOLRAD; treatment satisfaction
23.  Antimicrobial Susceptibility Testing of Helicobacter pylori in a Large Multicenter Trial: the MACH 2 Study 
Antimicrobial Agents and Chemotherapy  1999;43(11):2747-2752.
Culture and susceptibility testing of Helicobacter pylori strains was performed in a large multinational, multicenter randomized clinical trial. Culture was carried out on gastric biopsy samples obtained from 516 patients at entry and had a sensitivity of 99% when the [13C]urea breath test was used as a reference. Susceptibility testing was performed for clarithromycin and metronidazole on 485 strains by an agar dilution method and the epsilometer test (Etest) and for amoxicillin by an agar dilution method only. Resistance to clarithromycin (>1 μg/ml) was found in 3% of the H. pylori strains, with a perfect correlation between Etest and agar dilution methods. Resistance to metronidazole (>8 μl/ml) was found in 27% of the strains by agar dilution, but there were important discrepancies between it and the Etest method. No resistance to amoxicillin was found. The logarithms of the MICs of the three antibiotics against susceptible strains had a distribution close to normal. The impact of resistance was tested in the four arms of the trial. There were not enough clarithromycin-resistant strains to evaluate the impact of resistance on the cure rate of clarithromycin-based regimens. For metronidazole-resistant strains, the impact noted in the clarithromycin-metronidazole arm was partially overcome when omeprazole was added (76% eradication for resistant strains versus 95% for susceptible strains). Secondary resistance to clarithromycin occurred in strains from 12 of 105 patients (11.4%) after the failure of a clarithromycin-based regimen to effect eradication. The detection of point mutations in clarithromycin-resistant strains was performed by a combination of PCR and restriction fragment length polymorphism. Mutations (A2142G and 2143G) were found in all strains tested except one. This study stresses the importance of performing susceptibility tests in clinical trials in order to explain the results of different treatments.
PMCID: PMC89554  PMID: 10543758

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