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Alphonso Brown

Publications and source records attributed to Alphonso Brown.

13 recordsLinked to original sources
PubMed2006

Association of industry sponsorship to published outcomes in gastrointestinal clinical research.

BACKGROUND & AIMS: Recent years have seen an increase in industry sponsorship of clinical trials throughout medicine. We conducted a study to evaluate the association of industry sponsorship to published outcomes in gastrointestinal (GI) clinical research. Our aims were (1) to evaluate the trends in the source of funding for GI clinical research during the period from 1992 to 2002-2003, (2) to determine whether the source of study funding predicted the likelihood that a study would publish results that favor the drug or device being tested, and (3) to determine whether differences exist in the methodologic quality of the investigational study methods used in studies funded by private industry versus other sources. METHODS: We selected all clinical studies evaluating a drug or device from 4 prominent GI journals (Gastroenterology, The American Journal of Gastroenterology, Hepatology, and Gastrointestinal Endoscopy). All studies were abstracted by using a standardized data abstraction form. We evaluated the trends in funding source for studies published during the years 1992, 2002, and 2003. All selected studies were scored for methodologic quality by using a previously validated scoring system. The percentage of studies that reported outcomes that favored the device or drug being tested against the standard therapy or placebo was determined for each funding source. A funnel plot was constructed to assess for the presence of negative publication bias. RESULTS: A total of 6326 studies were reviewed. For the 1992 trend data, 1860 studies were reviewed, and 135 were selected for inclusion in the study. Ninety-five studies were studies involving the investigation of drugs, and 40 studies involved the testing of a device. For the 2002-2003 data 4466 studies were reviewed, and 315 were selected for inclusion in the study. Two hundred twenty-two studies were clinical trials involving the investigation of drugs, and 93 were clinical trials involving devices. In comparing 1992 to 2002, the percentage of studies funded by industry sources more than doubled from 10% to greater than 28% of the total studies assessed. There was an associated decline in the proportion of studies with funding from non-industry sources during this period (62% to less than 48%). The percentage of studies that did not disclose a funding source fell modestly from 28% to 24%. We found that 86% of studies funded by private industry reported a result favorable to the study drug or device, and 83% of studies funded by academic sources reported a result favorable to the study drug or device (P=.572). On average, studies funded by private industry had a higher methodology score than studies funded by traditional academic sources (75 of 100 vs 65 of 100; P=.005). Analysis of the funnel plot did not reveal evidence of bias against the publication of small studies with insignificant results. CONCLUSIONS: The proportion of research funded by industry has more than doubled during the last decade and currently comprises almost half of the funding for GI clinical research. Industry-sponsored studies are, on average, of superior methodologic quality to studies funded by other sources. Industry-sponsored studies in leading GI journals were no more likely than other studies to publish results that favored the study sponsor, although an extremely high percentage of all studies in these journals reported positive results. There has been only a modest decline in studies not acknowledging a funding source.

Clinical Trials as Topic↗
PubMed2006

The risk of retention of the capsule endoscope in patients with known or suspected Crohn's disease.

OBJECTIVES: Capsule endoscopy (CE) allows visualization of the mucosa of the entire small bowel and is therefore a potentially important tool in the evaluation of patients with known or suspected Crohn's disease (CD). However, small bowel strictures, which are not uncommon in Crohn's, are considered to be a contraindication to CE for fear of capsule retention. Our goal was to determine the risk of capsule retention in patients with suspected or known CD. METHODS: We retrospectively reviewed the records of 983 CE cases performed at three private gastroenterology practices between December 2000 and December 2003, and selected those with suspected or proven Crohn's. RESULTS: A total of 102 cases were identified in which CE was used in patients with suspected (N = 64) or known (N = 38) CD. Only one of 64 patients (1.6%) with suspected CD had a retained capsule. However, in five of 38 (13%) patients with known Crohn's, the capsule was retained proximal to a stricture. Of the five cases of retained capsules, three strictures were previously unknown. In four cases, the obstructing lesions were resected without complications, leading to complete resolution of the patient's underlying symptoms. One patient chose not to undergo surgery and has remained without an episode of small bowel obstruction for over 38 months. CONCLUSIONS: Capsule retention occurred in 13% (95% CI 5.6%-28%) of patients with known CD, but only in 1.6% (95% CI 0.2%-10%) with suspected Crohn's. A retained capsule may indicate unsuspected strictures in Crohn's that may require an unexpected, but therapeutic, surgical intervention. Patients and physicians should be aware of these potential risks when using CE in CD.

Adolescent↗
PubMed2006

Endoscopic sphincterotomy permits interval laparoscopic cholecystectomy in patients with moderately severe gallstone pancreatitis.

Patients with moderately severe gallstone pancreatitis with substantial pancreatic and peripancreatic inflammation, but without organ failure, frequently have an open cholecystectomy to prevent recurrent pancreatitis. In these patients, prophylactic endoscopic retrograde cholangiography (ERC) with endoscopic sphincterotomy (ES) may prevent recurrent pancreatitis, permit laparoscopic cholecystectomy, and decrease risks. The medical records of all patients with pancreatitis undergoing cholecystectomy from 1999-2004 at the University of North Carolina Memorial Hospital were reviewed. Data regarding demographics, clinical course, etiology of pancreatitis, operative and endoscopic interventions, and outcome were extracted. Moderately severe gallstone-induced pancreatitis was defined as pancreatitis without organ failure but with extensive local inflammation. Thirty patients with moderately severe gallstone pancreatitis underwent ERC and ES and were discharged before cholecystectomy. Mean interval between ES and cholecystectomy was 102 +/- 17 days. Cholecystectomy was performed laparoscopically in 27 (90%) patients, open in three (10%) patients, and converted to open in two (7%) patients, with a morbidity rate of 7% (two patients). No patient required drainage of a pseudocyst or developed recurrent pancreatitis. Interval complications resulted in hospital readmission in seven (23%) patients. In conclusion, recurrent biliary pancreatitis in patients with moderately severe gallstone pancreatitis is nil after ERC and ES. Hospital discharge of these patients permits interval laparoscopic cholecystectomy, but close follow-up is necessary in these potentially ill patients.

Cholangiopancreatography, Endoscopic Retrograde↗
PubMed2005

A national comparison of surgical versus percutaneous drainage of pancreatic pseudocysts: 1997-2001.

Case series results indicate that a surgical approach is superior to percutaneous drainage of pancreatic pseudocysts. To determine if this surgical advantage is persistent, national outcomes for both approaches were compared from 1997 through 2001. The National Inpatient Sample, a 20% sample of all nonfederal hospital discharges, was searched for patients who had a pancreatic pseudocyst diagnosis, an ICD-9 diagnosis code 577.2, and an ICD-9 procedure code of 52.01 for percutaneous drainage (PD) or 52.4 and 52.96 for the surgical approaches. Variables were compared by using either t test or chi2 analysis. Confounding variables were controlled for by linear or logistic regression models. No clinically significant demographic, comorbidity, and disease-specific severity-of-illness differences existed between the two groups. Significant differences in complications, length of stay (15+/-15 versus 21+/-22 days, P<0.0001), and inpatient mortality (5.9% versus 2.8%, P<0.0001) favored the surgical approach. In addition, endoscopic retrograde cholangiopancreatography use had a protective effect on mortality (odds ratio, 0.7), whereas percutaneous drainage had an increased risk of mortality (odds ratio, 1.4). This population-based study suggests that surgical drainage of pancreatic pseudocysts, particularly when coupled with use of endoscopic retrograde cholangiopancreatography, leads to decreased complications, length of stay, and mortality in comparison with percutaneous drainage.

Cholangiopancreatography, Endoscopic Retrograde↗
PubMed2005

The perception of cancer risk in patients with prevalent Barrett's esophagus enrolled in an endoscopic surveillance program.

BACKGROUND & AIMS: Patients with Barrett's esophagus (BE) have a risk of esophageal adenocarcinoma of approximately 0.5% per year. Patients may have difficulty understanding this risk. This study assessed the perceived risk of cancer in patients with BE, and correlated their risk estimates with their health care use behaviors. METHODS: We performed a survey of patients with BE participating in an endoscopic surveillance program at 2 sites: a university teaching hospital and a Veterans' Administration hospital. A questionnaire also elicited their demographics as well as their sources of health information. Health care behaviors, including physician visits and endoscopic surveillance behaviors, were assessed. Patients were classified as either overestimators or nonoverestimators of risk. Characteristics of overestimators, as well as health care use patterns, were assessed. RESULTS: One hundred eighteen patients met entry criteria, and 92 (78%) completed all the questionnaires. Sixty-eight percent of patients overestimated their 1-year risk of cancer, with a mean estimated 1-year cancer risk being 13.6%. The lifetime risk also was overestimated by 38% of patients. Patients who overestimated risk were more likely to be Veterans' Administration medical center patients, have more symptomatic reflux, and were more likely to use the Internet to get health care information. There was no significant difference in physician visits between overestimators and nonestimators (1.2 visits per year vs 1.0, P = .20), nor in endoscopy use (5.7 endoscopies per 5-year period vs 5.0, P = .42). CONCLUSIONS: The majority of patients with prevalent BE participating in an endoscopic surveillance program overestimated their chances of developing adenocarcinoma of the esophagus. Efforts to improve education of such patients with BE are warranted.

Adenocarcinoma↗
PubMed2004

Digestive and liver diseases statistics, 2004.

BACKGROUND & AIMS: Digestive and liver diseases are associated with substantial morbidity and mortality in the United States. Statistics about the incidence, prevalence, mortality, and resource utilization of digestive and liver diseases in the United States may be cumbersome to obtain because they are scattered in multiple sources. These data may be useful for policy makers, grant applicants, and authors. METHODS: Data on the most common gastrointestinal and liver diseases were collected from large publicly available national databases. Information was collected on inpatient and outpatient gastrointestinal complaints and diagnoses, gastrointestinal cancers, and deaths from common liver diseases. RESULTS: The leading gastrointestinal complaint prompting an outpatient visit is abdominal pain, with 12.2 million annual visits, followed by diarrhea, nausea, and vomiting. Abdominal pain is the leading outpatient gastrointestinal diagnosis, accounting for 5.2 million visits annually, followed by gastroesophageal reflux disease, with 4.5 million visits. Gallstone disease is the most common inpatient diagnosis, with 262,411 hospitalizations and a median inpatient charge of USD$11,584. Colorectal cancer is the most common gastrointestinal cause of death and is the most common gastrointestinal cancer, with an incidence of 54 per 100,000. Among gastrointestinal cancers, primary liver cancer had the highest increase in incidence from 1992 to 2000. CONCLUSIONS: Gastrointestinal and liver diseases are associated with significant outpatient and inpatient healthcare utilization. Following trends in utilization is important for determining allocation of resources for health care and research.

Biliary Tract Diseases↗
PubMed2004

Screening for upper gastrointestinal tract malignancies.

The screening for malignancies involving the upper gastrointestinal (GI) tract has taken on new importance as the incidence of cancers such as adenocarcinoma of the esophagus has risen. The availability of new screening technology and molecular biological techniques has dramatically improved our ability to detect early lesions. We have also developed a detailed understanding of the natural history of many upper GI malignancies. This new knowledge has led to significant improvement in population-based screening programs. In this review we will detail the evidence supporting our current screening methods and provide a concise overview of current screening recommendations for select upper GI malignancies.

Adenocarcinoma↗
PubMed2002

Initial evaluation of rectal bleeding in young persons: a cost-effectiveness analysis.

BACKGROUND: Evaluation of rectal bleeding in young patients is a frequent diagnostic challenge. OBJECTIVE: To determine the relative cost-effectiveness of alternative diagnostic strategies for young patients with rectal bleeding. DESIGN: Cost-effectiveness analysis using a Markov model. DATA SOURCES: Probability estimates were based on published medical literature. Cost estimates were based on Medicare reimbursement rates and published medical literature. TARGET POPULATION: Persons 25 to 45 years of age with otherwise asymptomatic rectal bleeding. TIME HORIZON: The patient's lifetime. PERSPECTIVE: Modified societal perspective. INTERVENTIONS: Diagnostic strategies included no evaluation, colonoscopy, flexible sigmoidoscopy, barium enema, anoscopy, or any feasible combination of these procedures. OUTCOME MEASURES: Life expectancy and costs. RESULTS OF BASE-CASE ANALYSIS: For 35-year-old patients, the no-evaluation strategy yielded the least life expectancy. The incremental cost-effectiveness of flexible sigmoidoscopy compared with no evaluation or with any strategy incorporating anoscopy (followed by further evaluation if no anal disease was found on anoscopy) was less than $5300 per year of life gained. A strategy of flexible sigmoidoscopy plus barium enema yielded the greatest life expectancy, with an incremental cost of $23 918 per additional life-year gained compared with flexible sigmoidoscopy alone. RESULTS OF SENSITIVITY ANALYSIS: As patient age at presentation of rectal bleeding increased, evaluation of the entire colon became more cost-effective. The incremental cost-effectiveness of flexible sigmoidoscopy plus barium enema compared with colonoscopy was sensitive to estimates of the sensitivity of the tests. In a probabilistic sensitivity analysis comparing flexible sigmoidoscopy with anoscopy followed by flexible sigmoidoscopy if needed, the middle 95th percentile of the distribution of the incremental cost-effectiveness ratios ranged from flexible sigmoidoscopy yielding an increased life expectancy at reduced cost to $52 158 per year of life gained (mean, $11 461 per year of life saved). CONCLUSIONS: Evaluation of the colon of persons 25 to 45 years of age with otherwise asymptomatic rectal bleeding increases the life expectancy at a cost comparable to that of colon cancer screening.

Adult↗
PubMed2002

Urinary trypsinogen activation peptide is more accurate than hematocrit in determining severity in patients with acute pancreatitis: a prospective study.

OBJECTIVE: The management of patients with acute pancreatitis is complicated by the inability to distinguish mild from severe disease during the early stages. It has been previously shown that urinary trypsinogen activation peptide (TAP) and hematocrit (Hct) may serve as early predictors of severity in patients with acute pancreatitis. To establish which marker is more accurate in the determination of severity in patients with acute pancreatitis, a prospective study was performed. METHODS: A consecutive series of patients admitted with pain consistent with acute pancreatitis and an amylase of three times the upper limit of normal were included. The admission and 24-h Hct was obtained. A urine sample was obtained within 12 h of admission. Urinary TAP was determined using a modified solid phase ELISA. Severity was defined by the Atlanta Symposium, as the presence of organ failure and/or pancreatic necrosis. RESULTS: Fifty-eight consecutive patients with acute pancreatitis participated. There were 33 men and 25 women with a mean age of 60 +/- 19. Thirty-nine patients had mild disease; 19 had severe disease. Urinary TAP was elevated in 26 patients. All patients with severe pancreatitis were correctly identified as having severe disease by an elevated urinary TAP (sensitivity 100%, specificity 77%). The admission Hct was higher than 47 in only three patients, all with mild disease. Of the patients with a rise in Hct, eight had mild disease, and only one had severe disease. Using a Hct of 44 as a cutoff did not affect the accuracy. There was no association between a rise in Hct and failure of Hct to decrease in the determination of severity. CONCLUSIONS: In comparison to admission Hct, urinary TAP was more accurate in determining severity in patients with acute pancreatitis by Atlanta, APACHE II, and Ranson criteria. We conclude that urinary TAP is a more accurate predictor of severity in patients with acute pancreatitis compared with Hct. Urinary TAP should be used to determine severity in patients early in the course of acute pancreatitis.

Acute Disease↗
PubMed2002

Can fluid resuscitation prevent pancreatic necrosis in severe acute pancreatitis?

BACKGROUND/AIMS: In previous studies, we have demonstrated that hemoconcentration was an early marker for necrotizing pancreatitis. The aim of the present study was to determine whether fluid resuscitation could prevent pancreatic necrosis among patients with hemoconcentration at the time of admission. METHODS: Data was pooled from the prior two studies of all patients with necrotizing pancreatitis and interstitial pancreatitis with a hematocrit of > or = 44 on admission. Hematocrit values in necrotizing pancreatitis and interstitial pancreatitis were compared at admission and at 24 h. Statistical analyses were performed using the Wilcoxon rank-sum test. RESULTS: A total of 39 patients satisfied our inclusion criteria, 28 with necrotizing pancreatitis and 11 with interstitial pancreatitis. Patients with necrotizing pancreatitis presented earlier than patients with interstitial pancreatitis (median 18 vs. 38 h, respectively) (p = 0.005). There was no significant difference between the intergroup median hematocrits on admission and at 24 h. All patients with hematocrits that failed to decrease at 24 h developed necrotizing pancreatitis (12/28 with necrotizing pancreatitis vs. 0/11 with interstitial pancreatitis) (p = 0.009). There was no significant difference at 24 h in rehydration among the three groups: 4.0 liters among the 12 patients with necrotizing pancreatitis whose hematocrits increased and 4.5 liters among the 16 whose hematocrits decreased at 24 h, and 4.1 liters among the 11 patients with interstitial pancreatitis (p = 0.81). CONCLUSION: Patients who presented early were more likely to have necrotizing pancreatitis than interstitial pancreatitis. While fluid resuscitation was not shown to prevent pancreatic necrosis, all patients with inadequate fluid resuscitation as evidenced by persistence of hemoconcentration at 24 h developed necrotizing pancreatitis.

Acute Disease↗