Background:

International guidelines for the management of nonvariceal upper gastrointestinal bleeding have not been widely adopted in clinical practice. We sought to determine whether a national, multifaceted intervention could improve adherence to guidelines, especially for patients at high risk of nonvariceal upper gastrointestinal bleeding.

Methods:

In this randomized trial, we stratified hospitals by region and size and allocated sites to either the control or experimental group. Health care workers in the experimental group were given published guidelines, generic algorithms, stratification scoring systems and written reminders and attended multidisciplinary guideline education groups and case-based workshops. These interventions were implemented over a 12-month period after randomization, with performance feedback and benchmarking. The primary outcome of adherence rates to key guidelines in endoscopic and pharmacologic management, determined by chart review, was adjusted according to site characteristics and possible within-site dependencies. We also report the rates of adherence to other recommendations.

Results:

Forty-three sites were randomized to the experimental (n = 21) or control (n = 22) groups. In our primary analysis, we compared patients before (experimental group: n = 402 patients; control group: n = 424 patients) and after (experimental group: n = 361 patients; control group: n = 389 patients) intervention. Patient-level analysis revealed no significant difference in adherence rates to the guidelines after the intervention (experimental group: 9.8%; control group: 4.8%; p = 0.99) after adjustment for the rate of adherence before the intervention (experimental group: 13.2%; control group: 7.1%). The adherence rates to other guidelines were similar and decreased over time, varying between 5% and 93%.

Interpretation:

This national knowledge translation–based trial suggests poor adherence to guidelines on nonvariceal upper gastrointestinal bleeding. Adherence was not improved by an educational intervention, which highlights both the complexity and poor predictability of attempting to alter the behaviour of health care providers (Trial registration: ClinicalTrials.gov, no. MCT-88113).

BACKGROUND:

Recent developments may alter the approach to patients presenting with gastroesophageal reflux disease (GERD)-like symptoms. A newly proposed Montreal consensus definition of Barrett’s esophagus includes all types of esophageal columnar metaplasia, with or without intestinal-type metaplasia. There is also increasing recognition of eosinophilic esophagitis (EE) in patients with GERD-like symptoms.

OBJECTIVE:

To quantify the impact of these developments on a multiphysician general gastroenterology practice in a tertiary care medical centre.

METHODS:

Medical charts of all patients having an initial gastroscopy for GERD-like symptoms over a one-year period were reviewed retrospectively, and audits of their endoscopic images and esophageal biopsies were performed.

RESULTS:

Of the 353 study participants, typical symptoms of heartburn and acid reflux were present in 87.7% and 23.2%, respectively. Less commonly, patients presented with atypical symptoms (eg, dysphagia in 9.4%). At endoscopy, 26% were found to have erosive esophagitis and 12% had endoscopically suspected esophageal metaplasia. Histological evaluation was available for 65 patients. Ten of the 65 biopsied patients (15%) met traditional criteria for Barrett’s esophagus (ie, exhibiting intestinal-type metaplasia), whereas 49 (75%) fulfilled the newly proposed consensus definition of Barrett’s esophagus. Five patients (7.7%) met the study criteria for EE (more than 20 eosinophils per high-power field), four of whom had not been previously recognized.

CONCLUSIONS:

Among patients presenting with GERD-like symptoms, the prevalence of Barrett’s esophagus may increase markedly if the Montreal definition is adopted. In addition, growing awareness of EE may lead to an increase in the prevalence of this diagnosis. Prospective studies of the management implications of these findings are warranted.

BACKGROUND:

Colonoscopy has become accepted as one of the most effective methods of screening patients for colorectal cancer, and is used to remove the majority of colonic adenomas.

OBJECTIVE:

Because of the paucity of such estimates in the literature and the significant number of candidates for this procedure, the present study was performed to estimate the direct hospital costs of both diagnostic and therapeutic (polypectomy) colonoscopy.

METHODS:

A microcosting methodology was used to itemize the costs of colonoscopy. Variable and fixed costs were divided into labour, supplies, equipment and overhead costs. A third-party payer perspective was adopted. All costs are expressed in 2007 Canadian dollars.

RESULTS:

The cost of a diagnostic colonoscopy was $157 and the cost of a therapeutic colonoscopy was $199. Overhead costs represented approximately 30% of these amounts. When physician fees were added, these costs rose to $352 and $467, respectively.

CONCLUSION:

Because the overhead costs represent a large proportion of the total costs, allocation methods for these costs should be improved to allow for a more precise determination of the total costs of a colonoscopy. These estimates are useful when analyzing the cost-effectiveness of a strategy that uses colonoscopy when screening for colorectal cancer.

BACKGROUND:

The Stretta procedure is an endoscopic therapy for gastroesophageal reflux disease.

OBJECTIVE:

To evaluate the cost-effectiveness of the Stretta procedure and that of competing strategies in the long-term management of gastroesophageal reflux disease.

METHODS:

A Markov model was designed to estimate costs and health outcomes in Canadian patients with gastroesophageal reflux disease over five years, from a Ministry of Health perspective. Strategies included the use of daily proton pump inhibitors (PPIs), laparoscopic Nissen fundoplication (LNF) and the Stretta procedure. Probabilities and utilities were derived from the literature. Costs are expressed in 2006 Canadian dollars. Units of effectiveness were symptom-free months (SFMs) and quality-adjusted life years (QALYs), using a five-year time horizon.

RESULTS:

In the analysis that used SFMs, the strategy using PPIs exhibited the lowest costs ($40 per SFM) and the greatest number of SFMs, thus dominating both the LNF and Stretta systems. But the cost-effectiveness analysis using QALYs as the measure of effectiveness showed that PPIs presented the lowest cost-effectiveness ratio, while both the LNF and Stretta strategies were associated with very high incremental costs (approximately $353,000 and $393,000, respectively) to achieve an additional QALY. However, the PPI strategy did not dominate the two other strategies, which were associated with better effectiveness.

CONCLUSIONS:

If SFMs are used as the measure of effectiveness, PPIs dominate the Stretta and LNF strategies. However, if QALYs are used, the PPIs still present the lowest cost and LNF gives the best effectiveness. Regardless of the units of effectiveness or utility used in the present cost analysis, an approach of prescribing PPIs appears to be the preferred strategy.

Background:

The frequency of polypectomy is an important indicator of quality assurance for population-based colorectal cancer screening programs. Although administrative databases of physician claims provide population-level data on the performance of polypectomy, the accuracy of the procedure codes has not been examined. We determined the level of agreement between physician claims for polypectomy and documentation of the procedure in endoscopy reports.

Methods:

We conducted a retrospective cohort study involving patients aged 50–80 years who underwent colonoscopy at seven study sites in Montréal, Que., between January and March 2007. We obtained data on physician claims for polypectomy from the Régie de l’Assurance Maladie du Québec (RAMQ) database. We evaluated the accuracy of the RAMQ data against information in the endoscopy reports.

Results:

We collected data on 689 patients who underwent colonoscopy during the study period. The sensitivity of physician claims for polypectomy in the administrative database was 84.7% (95% confidence interval [CI] 78.6%–89.4%), the specificity was 99.0% (95% CI 97.5%–99.6%), concordance was 95.1% (95% CI 93.1%–96.5%), and the kappa value was 0.87 (95% CI 0.83–0.91).

Interpretation:

Despite providing a reasonably accurate estimate of the frequency of polypectomy, physician claims underestimated the number of procedures performed by more than 15%. Such differences could affect conclusions regarding quality assurance if used to evaluate population-based screening programs for colorectal cancer. Even when a high level of accuracy is anticipated, validating physician claims data from administrative databases is recommended.

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.

BACKGROUND/OBJECTIVE:

Guidelines for the management of patients with nonvariceal upper gastrointestinal bleeding (NVUGIB) are inconsistently applied by health care providers, potentially resulting in suboptimal care and patient outcomes. A needs assessment was performed to assess health care providers’ barriers to the implementation of these guidelines in Canada.

METHODS:

Semistructured telephone interviews were conducted by trained research personnel with 22 selectively sampled health care professionals actively treating and managing NVUGIB patients, including emergency room physicians (ER), intensivists (ICU), gastroenterologists (GI), gastroenterology nurses and hospital administrators. Participants were chosen from a representative sample of six Canadian community- and academic-based hospitals that participated in a national Canadian audit on the management of NVUGIB.

RESULTS:

Participants reported substantive gaps in the implementation of NVUGIB guidelines that included the following: lack of knowledge of the specifics of the NVUGIB guidelines (ER, ICU, nurses); limited belief in the value of guidelines, especially in areas where evidence is lacking (ER, ICU); limited belief in the value of available tools to support implementation of guidelines (GI); lack of knowledge of the roles and responsibilities of health care professions and disciplines, and lack of effective collaboration skills (ER, ICU and GI); variability of knowledge and skills of health care professionals within professions (eg, variability of nurses’ knowledge and skills in endoscopic procedures); and perceived overuse of intravenous proton pump inhibitor treatment, with limited concern regarding cost or side effect implications (all participants).

CONCLUSIONS:

In the present study population, ER, ICU and nurses did not adhere to NVUGIB guidelines because they were neither aware of nor familiar with them, whereas the GI lack of adherence to NVUGIB guidelines was influenced more by attitudinal and contextual barriers. These findings can guide the design of multifaceted educational and behavioural interventions when attempting to effectively disseminate existing guidelines, and for guideline implementation into practice.

BACKGROUND:

Nonvariceal upper gastrointestinal bleeding (UGIB) is a serious medical condition requiring prompt resuscitation and early endoscopic therapy in those with high-risk endoscopic lesions (HRLs). There are little or no data correlating sole blood urea nitrogen (BUN) level with the severity of nonvariceal UGIB or the presence of HRLs in the adult population.

OBJECTIVES:

To determine if the BUN level on presentation correlates with parameters of severity of UGIB (need for blood transfusion or intensive care unit [ICU] admission) or to the subsequent finding of HRL, and in so doing identify patients who will require early endoscopic intervention.

METHODS:

The Canadian Registry of patients with Upper Gastrointestinal Bleeding undergoing Endoscopy was used to identify patients enrolled from the McGill University Health Centre (Montreal, Quebec) who presented with or developed acute nonvariceal UGIB while admitted. All comparisons were performed using Student’s t test or Wilcoxon’s signed rank test, as appropriate. Logistic regression modelling using a stepwise method was performed to identify independent predictors of severe nonvariceal UGIB and HRL.

RESULTS:

Two hundred nine patients were enrolled in the study. The mean age was 67±18 years and 59.8% were male. The mean BUN level was 13.4±9.4 mmol/L. Univariate analysis demonstrated that the BUN level was a significant predictor of ICU admission (BUN 14.7±10.4 mmol/L versus 12.0±8.0 mmol/L, P=0.035). However, when adjusted for systolic blood pressure, BUN level became a weaker predictor of ICU admission, just failing to achieve statistical significance (OR 1.03, 95% CI 1.00 to 1.06; P=0.08). Univariate analysis also demonstrated that BUN level was not a statistically significant predictor of blood transfusion requirement (BUN 14.1±10.6 mmol/L versus 13.6±8.6 mmol/L, P=0.508), nor of HRL (BUN 14.2±10.7 mmol/L versus 12.9±8.6 mmol/L, P=0.605).

CONCLUSION:

In patients with nonvariceal UGIB, the BUN level at initial presentation is a weak predictor of the severity of UGIB as defined by ICU admission, but is not helpful in identifying patients with a HRL.

Whether it is the primary reason for admission or a complication of critical illness, upper gastrointestinal bleeding is commonly encountered in the intensive care unit. In this setting, in the absence of endoscopy, intensivists generally provide supportive care (transfusion of blood products) and acid suppression (such as proton pump inhibitors). More recently, octreotide (a somatostatin analogue) has been used in such patients. However, its precise role in patients with upper gastrointestinal bleeding is not necessarily clear and the drug is associated with significant costs. In this issue of Critical Care, two expert teams debate the merits of using octreotide in non-variceal upper gastrointestinal bleeding.

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.

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.