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Biomedical subjects

B G Feagan

Publications and source records attributed to B G Feagan.

At least 37 records · Page 2Linked to original sources
PubMed2000

A controlled trial of a critical pathway for treatment of community-acquired pneumonia. CAPITAL Study Investigators. Community-Acquired Pneumonia Intervention Trial Assessing Levofloxacin.

CONTEXT: Large variations exist among hospitals in the use of treatment resources for community-acquired pneumonia (CAP). Lack of a common approach to the diagnosis and treatment of CAP has been cited as an explanation for these variations. OBJECTIVE: To determine if use of a critical pathway improves the efficiency of treatment for CAP without compromising the well-being of patients. DESIGN: Multicenter controlled clinical trial with cluster randomization and up to 6 weeks of follow-up. SETTING: Nineteen teaching and community hospitals in Canada. PATIENTS: A total of 1743 patients with CAP presenting to the emergency department at 1 of the participating institutions between January 1 and July 31, 1998. INTERVENTION: Hospitals were assigned to continue conventional management (n = 10) or implement the critical pathway (n = 9), which consisted of a clinical prediction rule to guide the admission decision, levofloxacin therapy, and practice guidelines. MAIN OUTCOME MEASURES: Effectiveness of the critical pathway, as measured by health-related quality of life on the Short-Form 36 Physical Component Summary (SF-36 PCS) scale at 6 weeks; and resource utilization, as measured by the number of bed days per patient managed (BDPM). RESULTS: Quality of life and the occurrence of complications, readmission, and mortality were not different for the 2 strategies; the 1-sided 95% confidence limit of the between-group difference in the SF-36 PCS change score was 2.4 points, which was within a predefined 3-point boundary for equivalence. Pathway use was associated with a 1.7-day reduction in BDPM (4.4 vs 6.1 days; P = .04) and an 18% decrease in the admission of low-risk patients (31% vs 49%; P = .01). Although inpatients at critical pathway hospitals had more severe disease, they required 1.7 fewer days of intravenous therapy (4.6 vs 6.3 days; P = .01) and were more likely to receive treatment with a single class of antibiotic (64% vs 27%; P<.001). CONCLUSION: In this study, implementation of a critical pathway reduced the use of institutional resources without causing adverse effects on the well-being of patients.

Aged↗
PubMed2000

Economic assessment of the community-acquired pneumonia intervention trial employing levofloxacin.

OBJECTIVE: The purpose of this study was to assess use of a critical pathway designed to manage community-acquired pneumonia more efficiently than its management with conventional therapy. METHODS: Economic outcomes were assessed in conjunction with a cluster-design, randomized, controlled trial. Nineteen participating Canadian hospitals were randomized to implement the critical pathway (n = 9) or conventional therapy (n = 10). The critical pathway included a clinical prediction rule to guide the admission decision, treatment with levofloxacin, and practice guidelines. Patient data on medical resource use, lost productivity, and quality of life were collected prospectively for > or =6 weeks after treatment. Costs were calculated from the government, health care system, and societal perspectives, with imputation of missing outpatient costs and the costs of lost productivity when necessary. Bootstrapping was used to identify 95% CIs for the total cost per patient. RESULTS: The analysis included all eligible patients in the critical pathway (n = 716) and conventional therapy (n = 1027) arms. There were fewer hospital admissions in the critical pathway arm than in the conventional therapy arm, both overall (46.5% vs 62.2%; P = 0.01) and in low-risk patients (33.2% vs 46.8%; P < 0.001). Compared with conventional therapy, hospitals in the critical pathway arm had 1.6 fewer bed days per patient managed (P = 0.05) and used fewer inpatient medical resources. The 2 study arms had similar outpatient, readmission, and lost-productivity costs, and similar quality-of-life outcomes. The critical pathway produced cost savings from all 3 perspectives that ranged from $457 to $994 per patient. CONCLUSIONS: The critical pathway employing levofloxacin resulted in cost savings compared with conventional therapy and did not compromise health outcomes.

Aged↗
PubMed2000

Quality of life rapidly improves with budesonide therapy for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group.

Our aims were to assess the impact on health-related quality of life (HRQOL) of a controlled ileal release (CIR) formulation of budesonide in active Crohn's disease (CD) and further define the role of HRQOL, using the Inflammatory Bowel Disease Questionnaire (IBDQ), in assessing outcome in CD. A randomized trial was conducted in 258 patients with active ileal or ileocecal CD. Budesonide CIR 1.5 mg, 4.5 mg, 7.5 mg, or placebo was given b.i.d. for 8 weeks. IBDQ score changes were compared among groups. Correlations for IBDQ and Crohn's Disease Activity Index (CDAI) scores were calculated. Mean IBDQ scores improved significantly over placebo by 2 weeks in budesonide 15 mg (155+/-38; p = 0.006) and 9 mg groups (157+/-33; p = 0.0002). Bowel, systemic, social, and emotional subscores were also significantly better (p < 0.002) at 2 and 8 weeks in the 9 mg group. Improved HRQOL scores correlated well with decreased CDAI (-0.8 < r < -0.4). Average per item change in IBDQ at remission was 1.17 to 1.48. Prior surgery (p < 0.005) or current smoker (p < 0.05) status predicted poorer initial HRQOL but not response. Budesonide CIR 9 or 15 mg/day rapidly and significantly improved HRQOL in active CD.

Adult↗
PubMed2000

Annual cost of care for Crohn's disease: a payor perspective.

OBJECTIVE: The aim of this study was to estimate the annual cost of care of patients with Crohn's disease according to treatment setting. METHODS: Using a 1994 integrated claims database, patients with a Crohn's-related medical claim (ICD-9 code 555) from 10/01/94 to 09/30/95 were included in this analysis. These patients were stratified into three mutually exclusive disease severity groups: group 1, required hospitalization for Crohn's; group 2, required chronic glucocorticoid or immunosuppressive drug therapy for >6 months; group 3, all remaining patients. Direct charges (based on reimbursement) and utilization of resources were reported for each group. RESULTS: Six-hundred-seven patients were analyzed: 117(19%) in group 1, 31(5%) in group 2, and 459(76%) in group 3. Average age of all patients was 48 years and 43% of these patients were men. Average annual charges for all patients totaled $12,417. Group I patients experienced the highest mean charges ($37,135), whereas patients in groups 2 and 3 incurred $10,033 and $6,277. Approximately 25% of patients accounted for 80% of the total charges. CONCLUSIONS: Crohn's disease is associated with high cost. Although a minority of Crohn's patients required hospitalization, they tended to have higher utilization and were responsible for a majority of total expenditures. New therapies have the potential to reduce overall cost of care, if they prevent Crohn's-related hospitalizations.

Crohn Disease↗
PubMed1999

Lack of effect of intravenous administration on time to respond to azathioprine for steroid-treated Crohn's disease. North American Azathioprine Study Group.

BACKGROUND & AIMS: Azathioprine is effective for Crohn's disease but acts slowly. A loading dose may decrease the time to response. METHODS: A placebo-controlled study was conducted in patients with active Crohn's disease despite prednisone treatment. Patients were randomized to a 36-hour infusion of azathioprine, 40 mg/kg (51 patients), or placebo (45 patients) followed by oral azathioprine, 2 mg/kg, for 16 weeks. Prednisone was tapered over 5 weeks. The primary outcome measure was complete remission at week 8, defined by discontinuation of prednisone and a Crohn's Disease Activity Index of </=150 points. Erythrocyte concentrations of the azathioprine active metabolite, 6-thioguanine nucleotide, were measured. RESULTS: At week 8, 13 patients (25%) were in complete remission in the azathioprine-loaded group compared with 11 patients (24%) in the placebo group. The frequency of complete remission did not increase after 8 weeks in either group. Both groups achieved steady state of 6-thioguanine nucleotide by week 2, and no differences were found in mean concentrations between the groups. There were no significant differences in the frequency of adverse events between the groups. CONCLUSIONS: A loading dose does not decrease the time to response in patients with steroid-treated Crohn's disease beginning azathioprine therapy. Steady state of erythrocyte 6-thioguanine nucleotide and complete response occurred earlier than previously reported.

Administration, Oral↗
PubMed1999

Clinical course and costs of care for Crohn's disease: Markov model analysis of a population-based cohort.

BACKGROUND & AIMS: Crohn's disease results in substantial morbidity and high use of health services. The aim of this study was to describe the lifetime clinical course and costs of Crohn's disease in a 24-year population-based inception cohort of patients with Crohn's disease in Olmsted County, Minnesota. METHODS: Disease states were defined by medical and surgical treatment. A Markov model analysis calculated time in each disease state and present value of excess lifetime costs in comparison with an age- and sex-matched cohort. RESULTS: For a representative patient, projected lifetime costs were $39,906 per patient using median charges and $125,404 using mean charges. There were 29.1 years (63% of total) without medications. There were 12.7 years (27%) on aminosalicylate therapy, generating $11,467 (29%) in charges, and 3.2 years (7%) on corticosteroid or immunosuppressive therapy, generating $5147 (13%) in charges. Surgery generated $17,526 (44%) in charges. CONCLUSIONS: Most of the clinical course is spent in remission, either medical or surgical. Aminosalicylate therapy accounts for 29% of the costs of care. Surgery has the highest charges but the longest remissions. Treatment strategies that induce remission in mild disease and maintain remission with lower-cost maintenance therapy will have the largest effect on patient outcomes and costs.

Adolescent↗
PubMed1999

Review article: economic issues in Crohn's disease--assessing the effects of new treatments on health-related quality of life.

The advent of highly effective yet costly new treatments for Crohn's disease will force clinicians, patients, and society to make important choices regarding the allocation of resources. Pharmacoeconomic analyses can be useful in deciding whether new technologies are of good value in comparison to established treatment regimens. In Crohn's disease conventional cost-effectiveness analyses are of limited use because surgery, death, and disease-related complications occur relatively infrequently. Alternatively, cost-utility models relate the incremental cost of new treatments to improvements in health-related quality of life. These analyses require the collection of valid cost and utility inputs that have only recently become available. Ultimately, cost-utility models should allow decision makers to make sensible choices for patients and society. This article describes the techniques of pharmacoeconomic analysis and reviews existing data on the measurement of costs and quality-of-life outcomes in Crohn's disease.

Algorithms↗
PubMed1997

A randomized study comparing a patient-directed hypertension management strategy with usual office-based care.

This study aimed to compare the efficacy of a patient-directed management strategy with office-based management in maintaining blood pressure control in patients with chronic stable hypertension using a randomized trial of two months duration. The subjects had chronic stable essential hypertension without secondary causes or unstable cardiovascular disease and were selected through the offices of 11 family physicians and a tertiary care hypertension research unit. Patients were randomly assigned (2:1 ratio) to either a patient-directed management strategy using home blood pressure monitoring to adjust drug therapy if readings consistently exceeded defined limits, or office-based management through physician visits. The primary endpoint was the change from baseline in mean arterial pressure as determined by automatic ambulatory blood pressure monitoring. Secondary endpoints were changes in compliance, quality of life, and health care resource use. Ninety-one potential subjects were screened and 31 were randomized. Subjects in the patient-directed management group employed the drug adjustment protocols appropriately without complications. A significant difference in change in mean blood pressure was observed, favoring the patient-directed management (-0.95 mm Hg and +1.90 mm Hg, respectively, for patient-directed management and office-based management, P = .039). Compliance rates and quality of life scores were not significantly different between groups. Physician visits were more frequent in the patient-directed management group (1.05 v 0.20 visits/8 weeks, respectively, for patient-directed management and office-based management groups, P = .045). A patient-directed hypertensive management strategy may be feasible for patients with chronic stable hypertension. Such a strategy may improve blood pressure control compared with usual office-based care. However, physician visits may be increased using this strategy, at least in the short term.

Adult↗
PubMed1997

Review article: Drug development in inflammatory bowel disease: budesonide--a model of targeted therapy.

The use of non-specific anti-inflammatory drugs such as the glucocorticoids is the foundation of medical therapy for inflammatory bowel disease. Although conventional steroid drugs are highly effective, their use is associated with the adverse effects of Cushing's syndrome. However, the therapeutic index of these drugs can be improved by chemical modification of the steroid nucleus and the use of new drug delivery systems that target the bowel wall as the pharmacokinetic compartment of interest. Budesonide is a novel glucocorticoid compound that illustrates the potential of this approach to identify effective and safe new treatments. Regional therapy for inflammatory bowel disease is an important pharmacological concept for the future development of the new glucocorticoids and other classes of drugs.

Administration, Oral↗
PubMed1997

Intravenous cyclosporine for severe attacks of ulcerative colitis: a survey of Canadian gastroenterologists.

UNLABELLED: A single randomized trial evaluated the use of intravenous cyclosporine treatment for severe attacks of ulcerative colitis. The perceived efficacy and safety of this intervention were measured through a survey of the membership of the Canadian Association of Gastroenterology (CAG). METHODS: All CAG members were mailed a survey with questions regarding their familiarity with the data supporting the use of cyclosporine, their perception of the efficacy and toxicity of the drug, and whether patients who fail conventional treatment should receive this therapy. The proportion of respondents who had used cyclosporine to treat severe ulcerative colitis was determined. RESULTS: One hundred and sixty-one responses were received (34% response rate). Sixty-four per cent of respondents were academic faculty members and 82% treated patients with severe colitis. Using multivariate analyses, positive associations were found between the respondents' age (P = 0.004) and subspecialty training in gastroenterology (P = 0.001), and whether respondents treat patients with severe ulcerative colitis. Twenty-six per cent of individuals had prescribed cyclosporine for this indication, of whom 88% were in academic practice (P = 0.007). Over 90% of respondents believe that further clinical trials are needed before cyclosporine becomes accepted as standard therapy. CONCLUSIONS: Although the use of cyclosporine is measurable among Canadian gastroenterologists, the majority believe that further clinical trials are necessary before the drug is accepted as a standard therapy.

Adult↗
PubMed1996

Does self-administration of a quality of life index for inflammatory bowel disease change the results?

We assessed the effect of self-administration of a disease-specific health-related quality of life instrument, the Inflammatory Bowel Disease Questionnaire (IBDQ), on score results. Patients were assessed at two visits in two tertiary centers. "Experienced" patients (N = 31) with Crohn's disease had previously completed the IBDQ several times while "novices" (N = 37) with Crohn's disease or ulcerative colitis had no prior exposure to the IBDQ. At each visit a self-administered IBDQ followed by a nurse-administered IBDQ (score range, 1-7; absolute score range, 32-224) and disease activity were assessed. At visit 1, the mean rates of discrepant responses between nurse and self-administered scores were 24 +/- 15% in experienced patients and 34 +/- 17% in novice patients (p = 0.018), which fell to 21 +/- 16 and 23 +/- 10%, respectively, by visit 2 (p = NS). However, discrepancy rates were not significantly different between novice and experienced patients when adjusted by center. Discrepancies occurred randomly in all 32 IBDQ items. Eighty percent of all discrepant responses differed by only one grade of a seven-point Likert scale. Baseline self-administered scores for all patients were 4.80 +/- 1.24 (absolute score, 153.0 +/- 39.9). Mean score differences at each visit (nurse minus self) were very small, ranging from 0.029 to 0.136, and would not be considered clinically important. Intraclass correlation coefficients between the nurse and self-administered IBDQ and the four dimensional scores were > or = 0.97 by visit 2, indicating excellent concordance and minimal observer error. Mean changes in score over time were of comparable magnitude for both self (0.320 +/- 0.819) and nurse (0.260 +/- 0.831) assessments. We conclude that the IBDQ may be reliably used as a self-administered instrument in clinical trials.

Adult↗
PubMed1996

Therapeutics and inflammatory bowel disease: a guide to the interpretation of randomized controlled trials.

Randomized controlled trials are the optimal means of assessing the efficacy of new treatments. This report reviews the methodology of clinical trials in inflammatory bowel disease using examples from recent randomized trials of therapy for Crohn's disease and other gastrointestinal diseases to show key principles. Guidelines for the practicing clinician to evaluate these studies are provided.

Guidelines as Topic↗
PubMed1996

Oral budesonide as maintenance treatment for Crohn's disease: a placebo-controlled, dose-ranging study. Canadian Inflammatory Bowel Disease Study Group.

BACKGROUND & AIMS: Budesonide is a corticosteroid with high topical anti-inflammatory activity and low systemic activity due to rapid hepatic metabolism. The efficacy and safety of an oral controlled-release preparation of budesonide for maintenance of remission was evaluated in patients with ileal or ileocecal Crohn's disease. METHODS: In a double-blind, multicenter trial, 105 patients were randomly assigned to receive placebo or budesonide at doses of 3 or 6 mg daily for 1 year. The primary outcome measure was relapse defined by a Crohn's Disease Activity Index score of > 150 and a minimum increase of 60 points. RESULTS: Patients receiving 6 mg of budesonide had a median time to relapse or discontinuation of therapy of 178 days compared with 124 days in those receiving 3 mg of budesonide and 39 days in those receiving placebo. However, at 1 year, the rate of relapse in the group receiving 6 mg of budesonide was similar to the rates in the 3-mg and placebo groups. Basal plasma cortisol levels and incidence of corticosteroid-associated effects were similar in the three groups. CONCLUSIONS: Oral controlled-release budesonide (6 mg/day) was well tolerated and prolonged remission in Crohn's disease of the ileum and proximal colon, but this effect was not sustained at 1-year follow-up.

Administration, Oral↗