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Biomedical subjects

T F Imperiale

Publications and source records attributed to T F Imperiale.

At least 19 recordsLinked to original sources
PubMed2000

Risk of advanced proximal neoplasms in asymptomatic adults according to the distal colorectal findings.

BACKGROUND AND METHODS: The clinical significance of a distal colorectal polyp is uncertain. We determined the risk of advanced proximal neoplasia, defined as a polyp with villous features, a polyp with high-grade dysplasia, or cancer, among persons with distal hyperplastic or neoplastic polyps as compared with the risk among persons with no distal polyps. We analyzed data from 1994 consecutive asymptomatic adults (age, 50 years or older) who underwent colonoscopic screening for the first time between September 1995 and December 1998 as part of a program sponsored by an employer. The location and histologic features of all polyps were recorded. Colonoscopy to the level of the cecum was completed in 97.0 percent of the patients. RESULTS: Sixty-one patients (3.1 percent) had advanced lesions in the distal colon, including 5 with cancer, and 50 (2.5 percent) had advanced proximal lesions, including 7 with cancer. Twenty-three patients with advanced proximal neoplasms (46 percent) had no distal polyps. The prevalence of advanced proximal neoplasia among patients with no distal polyps was 1.5 percent (23 cases among 1564 persons; 95 percent confidence interval, 0.9 to 2.1 percent). Among patients with distal hyperplastic polyps, those with distal tubular adenomas, and those with advanced distal polyps, the prevalence of advanced proximal neoplasia was 4.0 percent (8 cases among 201 patients), 7.1 percent (12 cases among 168 patients), and 11.5 percent (7 cases among 61 patients), respectively. The relative risk of advanced proximal neoplasia, adjusted for age and sex, was 2.6 for patients with distal hyperplastic polyps, 4.0 for those with distal tubular adenomas, and 6.7 for those with advanced distal polyps, as compared with patients who had no distal polyps. Older age and male sex were associated with an increased risk of advanced proximal neoplasia (relative risk, 1.3 for every five years of age and 3.3 for male sex). CONCLUSIONS: Asymptomatic persons 50 years of age or older who have polyps in the distal colon are more likely to have advanced proximal neoplasia than are persons without distal polyps. However, if colonoscopic screening is performed only in persons with distal polyps, about half the cases of advanced proximal neoplasia will not be detected.

Adenoma↗
PubMed2000

Pharmacologic treatment of the irritable bowel syndrome: a systematic review of randomized, controlled trials.

PURPOSE: To evaluate the efficacy of pharmacologic agents for the irritable bowel syndrome. DATA SOURCES: Electronic literature search of MEDLINE (1966 to 1999), EMBASE (1980 to 1999), PsycINFO (1967 to 1999), and the Cochrane controlled trials registry and a manual search of references from bibliographies of identified articles. STUDY SELECTION: Randomized, double-blind, placebo-controlled, parallel, or crossover trials of a pharmacologic intervention for adult patients that reported outcomes of improvement in global or irritable bowel-specific symptoms. DATA EXTRACTION: Qualitative and quantitative data reported on study groups, interventions, treatment outcomes, and trial methodologic characteristics. DATA SYNTHESIS: 70 studies met the inclusion criteria. The most common medication classes were smooth-muscle relaxants (16 trials), bulking agents (13 trials), prokinetic agents (6 trials), psychotropic agents (7 trials), and loperamide (4 trials). The strongest evidence for efficacy was shown for smooth-muscle relaxants in patients with abdominal pain as the predominant symptom. Loperamide seems to reduce diarrhea but does not relieve abdominal pain. Although psychotropic agents were shown to produce global improvement, the evidence is based on a small number of studies of suboptimal quality. Psychotropic drugs, 5-hydroxytryptamine (5-HT)-receptor antagonists, peppermint oil, and Chinese herbal medicine require further study. CONCLUSIONS: Smooth-muscle relaxants are beneficial when abdominal pain is the predominant symptom. In contrast, the efficacy of bulking agents has not been established. Loperamide is effective for diarrhea. Evidence for use of psychotropic agents is inconclusive; more high-quality trials of longer duration are needed. Evidence for the efficacy of 5-HT-receptor antagonists seems favorable, although more studies are needed.

Antidiarrheals↗
PubMed1999

Cost-effectiveness analysis of hepatitis A vaccination strategies for adults.

Our objective in this study was to determine the cost-effectiveness of hepatitis A vaccination strategies in healthy adults in the United States. We constructed a decision model simulating costs and health consequences for otherwise healthy adults with respect to hepatitis A prevention. Three strategies were compared: (1) no intervention, (2) vaccination against hepatitis A, and (3) testing for antibodies to hepatitis A and vaccinating those without antibodies. Costs and probabilities were obtained from the published literature. One- and two- way sensitivity analyses were performed. Under baseline conditions, the "test" strategy cost $230,100 per life-year saved compared with the "no intervention" strategy. The incremental cost-effectiveness of the "vaccination" strategy compared with the "test" strategy was $20.1 million per life-year saved. The "test" strategy was cost-effective when the hepatitis A case fatality rate exceeded 17% (baseline 2.7%). The "vaccination" strategy was cost-effective when 1 dose of vaccine cost $7 or less (baseline $57). Under baseline conditions, neither the "test" nor the "vaccination" strategies are considered cost-effective according to current standards. Large changes in hepatitis A incidence, mortality rates, or vaccine cost are required for either of the intervention strategies to approach potentially cost-effectiveness. Such conditions may occur in areas in which hepatitis A is endemic, and/or under mass-vaccination scenarios.

Cost-Benefit Analysis↗
PubMed1999

Patients willing to try colonoscopy without sedation: associated clinical factors and results of a randomized controlled trial.

BACKGROUND: Sedation causes most of the complications of colonoscopy. Sedation is used selectively in some countries but is routine in the United States. METHODS: Cross-sectional survey and randomized controlled trial were used to identify patient factors associated with willingness to try colonoscopy without sedation and to compare pain and satisfaction scores and willingness to return to the same physician in patients randomized to receive routine sedation versus as needed sedation. A single colonoscopist invited 250 consecutive eligible outpatients to be randomized to routine sedation versus as needed sedation. Seventeen who preferred no sedation and 163 who preferred sedation refused. Seventy accepted and were randomized. RESULTS: Male gender (odds ratio 4.33; 95% CI [2.27, 8.26]), increasing age (odds ratio for 10-year increase 1.28; 95% CI [1.01, 1.06]), and absence of abdominal pain (odds ratio 5.13; 95% CI [1.68, 15.63]) were associated with willingness to be randomized. Total colonoscopy was achieved without sedation in 94% of those who received sedation only as needed. Pain scores were higher in the sedation as needed arm. All 35 patients in the routine sedation arm were "very satisfied". In the sedation as needed arm, 31 of the 34 were "very satisfied" and 3 were "somewhat satisfied". All randomized patients said they would return to the same colonoscopist. Patients in the sedation as needed arm had less decline in blood pressure, less hypoxemia, and lower charges than those in the routine sedation arm. CONCLUSIONS: Experienced colonoscopists should consider offering colonoscopy without sedation to selected patients.

Analgesics, Opioid↗
PubMed1999

The utility of clinical and radiographic features in the diagnosis of cytomegalovirus central nervous system disease in AIDS patients.

BACKGROUND: Polymerase chain reaction (PCR) assays of cerebrospinal fluid (CSF) for cytomegalovirus (CMV) DNA have facilitated the diagnosis of CMV-associated central nervous system disease in AIDS patients. We attempt to correlate clinical and radiographic features that are associated with CMV PCR- positivity in CSF from AIDS patients with neurologic disease. METHODS AND RESULTS: A retrospective case controlled comparison was made of CMV PCR-positive and PCR-negative patients. RESULTS: CMV PCR-positive patients were significantly more likely to have nystagmus, prior CMV retinitis, and CSF protein levels.90 mg/dL. Of patients with 0, 1, and $2 of these features, 5.6%, 55.2%, and 88.9%, respectively, were PCR-positive. Ependymal enhancement was present by magnetic resonance imaging in 9 of 12 PCR-positive, and in 8 of 30 PCR-negative patients. CONCLUSION: These clinical and radiographic features may serve as useful adjuncts toward the establishment of the diagnosis of CMV-associated neurologic disease in AIDS patients.

AIDS-Related Opportunistic Infections↗
PubMed1999

Predictors of large esophageal varices in patients with cirrhosis.

OBJECTIVE: Recent guidelines recommend that all cirrhotics undergo screening upper endoscopy to identify those patients at risk for bleeding from varices. However, this practice may not be cost effective as large esophageal varices are seen only in 9-36% of these patients. The aim of this study was to determine whether clinical variables were predictive of the presence of large esophageal varices. METHODS: This is a retrospective analysis of cirrhotics who had a screening upper endoscopy during an evaluation for liver transplantation at three different centers and who had not previously bled from varices. A multivariate model was derived on the combined cohort using logistic regression. Three hundred forty-six patients were eligible for the study. RESULTS: The prevalence of large esophageal varices was 20%. On multivariate analysis, splenomegaly detected by computed tomographic scan (odds ratio: 4.3; 95% confidence interval: 1.6-11.5) or by physical examination (odds ratio: 2.0; 95% confidence interval: 1.1-3.8), and low platelet count were independent predictors of large esophageal varices. On the basis of these variables, cirrhotics were stratified into high- and low-risk groups for the presence of large esophageal varices. Patients with a platelet count of > or = 88,000/mm3 (median value) and no splenomegaly by physical examination had a risk of large esophageal varices of 7.2%. Those with splenomegaly or platelet count < 88,000/mm3 had a risk of large esophageal varices of 28% (p < 0.0001). CONCLUSIONS: Our data show that clinical predictors could be used to stratify cirrhotic patients for the risk of large esophageal varices and such stratification could be used to improve the cost effectiveness of screening endoscopy.

Adrenergic beta-Antagonists↗
PubMed1999

Meta-analysis: when and how.

Systematic reviews have a central role in evidence-based medicine. The quantitative systematic review, also known as meta-analysis, provides a logical structure for quantifying evidence and for exploring bias and diversity in research systematically. It is essential that clinicians, educators, and researchers understand the methods that comprise this research tool, particularly the basic step-by-step process, and know when numerical pooling of data is appropriate. The essay describes how systematic reviews are best conducted and when statistical pooling of data is appropriate. Systematic reviews are scientific investigations with planned methods that use original studies as subjects and synthesize the results of multiple studies using strategies to limit bias and random error. This process requires judgments to be made explicit, and should be question driven, protocol based, reproducible, and comprehensive in scope. Meta-analysis provides a framework for research synthesis, increases power and precision, provides an overall estimate and range of effect, and identifies greater-than-expected variability among study results (heterogeneity). Meta-analysis does not remove subjectivity from the process of synthesis, identify sources of variability among studies, or obviate the need for sound, compassionate clinical reasoning. Statistical heterogeneity should be anticipated and welcomed. It forces a consideration of clinical heterogeneity as well as variation in study protocol and quality. Statistical tests for homogeneity are insensitive and do not indicate sources of heterogeneity, making such consideration imperative. The most common and popular measures of efficacy for a meta-analysis are the standardized difference between two means, the relative risk, and the odds ratio. An additional measure, the number needed to treat, with its 95% confidence interval is the most clinically useful measure of the effects of an intervention and is useful for comparing the relative effectiveness of different interventions for the same condition. Important parts of meta-analysis and sensitivity and subgroup analyses are best considered a priori and should be used to explore heterogeneity and to test for publication bias and variation in study quality.

Evidence-Based Medicine↗
PubMed1998

Meta-analysis and cost comparison of polyethylene glycol lavage versus sodium phosphate for colonoscopy preparation.

BACKGROUND: Although polyethylene glycol lavage solutions are widely used for colonoscopy preparation, evidence suggests that sodium phosphate is better tolerated and has similar efficacy. The purpose of this study was to compare compliance with and efficacy of polyethylene glycol and sodium phosphate using meta-analysis and to compare the cost of colonoscopy with both methods. METHODS: We used Medline to identify all randomized controlled trials comparing the two preparations. Study methods were evaluated, and quantitative data were abstracted independently, including inability to complete the preparation and preparation quality, rated as adequate or excellent. A random effects model was used to calculate the pooled relative risk. Direct costs and literature-based probability estimates were used to compare costs. RESULTS: Among 1286 subjects from eight colonoscopist-blinded trials, the pooled relative risk of inability to complete the preparation was 0.23 (95% CI [0.18-0.28]) in favor of sodium phosphate. Although the best estimate of the relative risk for an adequate quality preparation revealed therapeutic equivalence (relative risk = 1.06: 95% CI [0.95-1.19]), an excellent quality preparation was more likely with sodium phosphate (relative risk = 1.72: 95% CI [1.16-2.53]). Assuming reexamination rates from published literature of 3% and 8% for sodium phosphate and polyethylene glycol, respectively, direct costs of colonic examination were $465 and $503. There were no clinically important adverse effects with either method. CONCLUSION: The results suggest that sodium phosphate is as effective and less costly, with a more easily completed preparation, compared with polyethylene glycol and is the preferred method of preparation for colonoscopy for certain patient subgroups.

Adult↗
PubMed1997

Somatostatin or octreotide compared with H2 antagonists and placebo in the management of acute nonvariceal upper gastrointestinal hemorrhage: a meta-analysis.

PURPOSE: To determine the efficacy of somatostatin or octreotide for the treatment of acute nonvariceal upper gastrointestinal hemorrhage. DATA SOURCE: Database searches of English-language articles published between 1966 and 1996 and the bibliographies of all related articles and textbook chapters. STUDY SELECTION: Randomized clinical trials comparing somatostatin or octreotide with H2 blockers or placebo in patients with a clinical or endoscopic diagnosis of acute nonvariceal upper gastrointestinal hemorrhage. DATA EXTRACTION: Methods and quality of the studies were evaluated, and quantitative data on outcomes, including continued bleeding, rebleeding during the treatment period, need for surgery, and transfusion requirement, were extracted. DATA SYNTHESIS: Among 1829 patients from 14 trials, the relative risk (RR) for continued bleeding or rebleeding was 0.53 (95% CI, 0.43 to 0.63) in favor or somatostatin, with a number needed to treat (NNT) of 5. Among 7 investigator-blinded trials, the relative risk was 0.73 (CI, 0.64 to 0.81) and the NNT was 11. Somatostatin was efficacious for peptic ulcer bleeding (RR, 0.48 [CI, 0.39 to 0.59]; NNT, 4) and showed a trend toward efficacy for non-peptic ulcer bleeding (RR, 0.62 [CI, 0.39 to 1.002]). Although the overall results suggested a decreased need for surgery in the somatostatin group, a subgroup analysis of investigator-blinded trials revealed a more modest effect that was not statistically significant (RR, 0.94 [CI, 0.87 to 1.001]). CONCLUSION: Somatostatin may reduce the risk for continued bleeding from acutely bleeding peptic ulcer disease. Somatostatin may be useful either as an adjunct treatment before endoscopy or when endoscopy is unsuccessful, contraindicated, or unavailable.

Acute Disease↗
PubMed1997

Primary prophylaxis of variceal bleeding in cirrhosis: a cost-effectiveness analysis.

BACKGROUND & AIMS: Prophylaxis against the first variceal bleeding has been proposed to reduce morbidity and mortality in cirrhotic patients. No previous information is available regarding the cost-effectiveness of prophylaxis. The aim of this study was to compare the cost-effectiveness of variceal bleeding prophylaxis with propranolol, sclerotherapy, and shunt surgery in cirrhotic patients stratified by bleeding risk. METHODS: A hypothetical cohort was stratified according to bleeding risk. The natural history of cirrhosis with esophageal varices was simulated using a Markov model. Transitional probabilities extracted from published studies and costs were obtained from our institution's billing department. Sensitivity analyses were performed for important variables. RESULTS: Propranolol results in cost savings ranging between $450 and $14,600 over a 5-year period. The extent of cost savings depended on the individual patient's bleeding risk. In addition, propranolol increased the quality-adjusted life expectancy by 0.1-0.4 years. Sclerotherapy was significantly less cost-effective than propranolol and had no advantage on quality of life. Shunt surgery was effective therapy for prevention of bleeding but decreased life expectancy and quality of life in some risk groups and was not cost-effective. CONCLUSIONS: Propranolol is the only cost-effective form of prophylactic therapy for preventing initial variceal bleeding in cirrhosis regardless of bleeding risk.

Cost-Benefit Analysis↗
PubMed1995

A cost analysis of alternative treatments for duodenal ulcer.

OBJECTIVE: To compare the costs of alternative strategies for the treatment of duodenal ulcer. DESIGN: A cost comparison using decision analysis. METHODS: A decision model was used to compare the costs per cure of an endoscopically documented duodenal ulcer for three initial treatment strategies: 1) H2-receptor antagonist therapy for 8 weeks, 2) antibiotic therapy for Helicobacter pylori infection plus H2-receptor antagonist therapy, and 3) urease test-based treatment. For symptomatic recurrences, secondary treatment strategies included empiric retreatment with the same or other regimen, and treatment based on repeat endoscopy-guided urease test or biopsy, with an assumption of subsequent cure. The cohort modeled for this analysis consisted of patients at low risk for a malignant ulcer. Probability estimates were derived from published clinical trials, cohort studies, and expert opinion. Side effects from combination therapy with antibiotics and H2-receptor antagonists and resulting costs were included from the perspective of a group practice model health maintenance organization. RESULTS: For all secondary treatment strategies, initial therapy with antibiotics for H. pylori infection plus an H2-receptor antagonist resulted in the lowest average costs per symptomatic cure when the prevalence or likelihood of H. pylori infection exceeded 66% to 76%; the costs ranged from $284 for secondary (re)treatment with empiric antibiotic and H2-receptor antagonist therapy to $398 for endoscopy-guided secondary treatment. Initial treatment with an H2-receptor antagonist resulted in the highest costs, ranging from $372 for secondary treatment with empiric antibiotic and H2-receptor antagonist therapy to $679 for endoscopy-guided secondary treatment. The results were not sensitive to the rates of duodenal ulcer recurrence after either treatment, to the cost of either treatment, or to prevalence of H. pylori. CONCLUSIONS: This cost analysis indicates that, regardless of the secondary treatment used for ulcer recurrence, initial therapy with antibiotics for H. pylori infection plus an H2-receptor antagonist provides the lowest costs per symptomatic cure. These cost savings and the lower recurrence rates associated with this treatment favor eradication of H. pylori as part of the initial treatment of duodenal ulcer.

Anti-Bacterial Agents↗
PubMed1995

A meta-analysis of somatostatin versus vasopressin in the management of acute esophageal variceal hemorrhage.

BACKGROUND & AIMS: Although sclerotherapy is the current standard therapy for bleeding esophageal varices, the best method for initial control is unclear. The aim of this meta-analysis was to compare the efficacy and toxicity of somatostatin and vasopressin in short-term treatment of hemorrhage from esophageal varices. METHODS: Using MEDLINE, all randomized trials comparing somatostatin with vasopressin in subjects with endoscopically documented acute esophageal variceal bleeding were identified. The quality of each study was critically and independently evaluated, and quantitative data for initial cessation of bleeding, sustained control of bleeding, and major adverse effects were abstracted. The relative risk (RR) and number needed to be treated were calculated. RESULTS: The RR or likelihood of achieving initial control of bleeding with somatostatin vs. vasopressin was 1.62 (95% confidence interval [CI], 1.37-1.93), and the number needed to be treated was 3.7, i.e., between 3 and 4 patients would have to be treated with somatostatin for 1 patient to derive additional benefit over vasopressin. For trials that measured sustained control of bleeding, somatostatin was superior to vasopressin (RR, 1.28 [95% CI, 1.00-1.65]; number needed to be treated, 8.8). The risk of adverse effects was greater for subjects given vasopressin (10% vs. 0%; P = 0.00007). CONCLUSIONS: This meta-analysis suggests that somatostatin is more efficacious in controlling acute hemorrhage from esophageal varices and has a lower risk of adverse effects than vasopressin.

Acute Disease↗
PubMed1995

Are cytotoxic agents beneficial in idiopathic membranous nephropathy? A meta-analysis of the controlled trials.

The use of cytotoxic agents for the treatment of idiopathic membranous nephropathy is controversial. Although several controlled trials have been published, both the comparison groups and the study findings have varied, resulting in clinical uncertainty. To explore this uncertainty, a meta-analysis of controlled trials of treatment with cyclophosphamide or chlorambucil was performed in patients with idiopathic membranous nephropathy and nephrotic-range proteinuria. Patients in the control groups received only symptomatic treatment or corticosteroids. Descriptive and quantitative data from each trial were abstracted independently. Outcomes included effects of treatment on renal function and proteinuria, with a complete remission (CR) or partial remission (PR) defined as the complete or partial resolution of proteinuria without deterioration of renal function. For patients having either any response (CR or PR) or only a CR, both the relative risk (RR) and the number needed to be treated were calculated. The five trials that satisfied criteria for inclusion in the analysis were clinically and statistically homogeneous. There were no placebo-controlled trials that met the criteria for inclusion. Among the 228 patients in these studies, the RR of achieving any response with cytotoxic agents was 2.3 (95% confidence interval, 1.7 to 3.2) and the RR for a CR was 4.6 (95% confidence interval, 2.2 to 9.3), with respective numbers needed to be treated of 2.9 and 4.7, meaning that between three and five patients would need to be treated with cytotoxic agents to achieve one response. Exclusion of the only nonrandomized trial had no significant effect on the results. Both chlorambucil and cyclophosphamide showed similar beneficial effects.(ABSTRACT TRUNCATED AT 250 WORDS)

Chlorambucil↗
PubMed1994

A meta-analysis of methods to prevent venous thromboembolism following total hip replacement.

OBJECTIVE: While several methods of prophylaxis have been shown to reduce the risk of venous thromboembolism following total hip replacement, the safest and most effective agent is unclear. To clarify this issue, we performed a meta-analysis of the randomized trials of methods used to prevent venous thromboembolism following total hip replacement. DATA SOURCE: English-language human studies articles from 1966 through 1993 were obtained from a MEDLINE database search with indexing terms including thromboembolism, hip replacement or hip prosthesis, and randomized controlled trials. Additional references were obtained from study bibliographies. STUDY SELECTION: The following criteria were used to select studies for inclusion: study design--randomized clinical trial; study population--patients undergoing elective total hip replacement; interventions--aspirin, warfarin, dextran, heparin, low-molecular-weight heparin, compression stockings; and outcomes--venous thromboembolism, major hemorrhage. DATA EXTRACTION: Methodological and descriptive data from each study were abstracted by one author who was blinded to quantitative outcomes data. DATA SYNTHESIS: Ninety-one treatment groups and 25 control groups were identified from 56 trials. Four treatment groups were excluded because of rarely used combinations. Trial populations were clinically homogeneous. When compared with the control arm, all treatments except aspirin reduced the risk of all deep venous thromboses (risk differences range, 0.18 to 0.31; all P values < .05). All treatments except aspirin reduced the risk of proximal venous thrombosis (risk differences range, 0.09 to 0.18; all P values < .05). Only low-molecular-weight heparin and stockings reduced the risk of pulmonary embolism, both with risk differences equal to 0.02. The crude risks of clinically important bleeding as defined by the individual trials were 0% for stockings, 0.3% for controls, and 1.8% for low-molecular-weight heparin. CONCLUSIONS: The results suggest that low-molecular-weight heparin and compression stockings have the greatest relative efficacy in preventing venous thromboembolism following total hip replacement. Low-molecular-weight heparin may be more effective, though at a small risk of clinically important bleeding.

Aspirin↗