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James M Scheiman

Publications and source records attributed to James M Scheiman.

14 recordsLinked to original sources
PubMed2003

Potential effect of cyclooxygenase-2-specific inhibitors on the prevention of colorectal cancer: a cost-effectiveness analysis.

PURPOSE: To estimate the potential cost-effectiveness of colorectal cancer chemoprevention with cyclooxygenase-2-specific inhibitors (COX-2 inhibitors). METHODS: Using a decision analytic Markov model, we estimated the discounted cost per life-year saved for three strategies: a COX-2 inhibitor alone; as an adjunct to colonoscopy every 10 years in persons at average risk of colorectal cancer; and as an adjunct to colonoscopy every 5 years in persons with first-degree relatives who had colorectal cancer. RESULTS: In the base case, the incremental cost per life-year saved with a COX-2 inhibitor alone compared with no screening was 233,300 dollars in persons at average risk of colorectal cancer and 56,700 dollars in persons with 2 first-degree relatives who had the disease. Chemoprevention was both less effective and more costly than screening. The incremental cost per life-year saved with a COX-2 inhibitor as an adjunct to screening was 823,800 dollars in persons at average risk and 404,700 dollars in persons with 2 first-degree relatives who had colorectal cancer. Combining a COX-2 inhibitor with less frequent screening was not as cost-effective as screening at currently recommended intervals. Cost-effectiveness estimates were highly sensitive to the cost of COX-2 inhibitors and their effect on the risk of cancer. CONCLUSION: Chemoprevention of colorectal cancer with COX-2 inhibitors is likely to incur substantially higher costs per life-year saved than are currently recommended screening strategies. COX-2 inhibitor use as an adjunct to screening may increase life expectancy, although at prohibitive costs, and is unlikely to result in less frequent screening.

Aged↗
PubMed2003

Making cost-effectiveness analyses clinically relevant: the effect of provider expertise and biliary disease prevalence on the economic comparison of alternative diagnostic strategies.

RATIONALE AND OBJECTIVES: This study was performed to assess the incremental cost-effectiveness of initial magnetic resonance cholangiopancreatography (MRCP) and initial endoscopic ultrasonography (EUS) compared with initial endoscopic retrograde cholangiopancreatography (ERCP) and to evaluate the effect of MRCP provider expertise on the relative cost-effectiveness of the three methods. MATERIALS AND METHODS: Thirty patients with suspected biliary disease and referred for ERCP were prospectively evaluated with EUS, MRCP, or ERCP within 24 hours of referral, according to institutional review board-approved protocol. Performance characteristics were measured for EUS and MRCP, with ERCP as the reference standard. A decision analysis compared the clinical and economic effects of three diagnostic strategies (ERCP, EUS followed by ERCP [EUS-ERCP], and MRCP followed by ERCP [MRCP-ERCP]) using prospective EUS and MRCP test characteristics and Medicare reimbursements. The added costs per additional correct diagnosis and per additional false-positive finding averted and the rates and costs of ERCP-related complications were calculated for EUS-ERCP and MRCP-ERCP. Two additional MRCP readers reviewed MRCP data to evaluate interobserver variability and estimate provider expertise. Additional economic analyses incorporated these estimates. RESULTS: Compared with initial ERCP, EUS-ERCP demonstrated 72% of biliary abnormalities and reduced ERCP-related complications by 60%; the corresponding percentages for MRCP-ERCP were 48% and 40%. Initial EUS and initial MRCP decreased the number of ERCP procedures performed by 69% and 49%, respectively. Each correct diagnosis made with ERCP that would not have been made with initial EUS or initial MRCP cost an additional 4,875 dollars or 2,580 dollars, respectively. Each false-positive diagnosis averted with initial ERCP that would have been made with EUS-ERCP or MRCP-ERCP cost an additional 9,750 dollars or 1,548 dollars, respectively. The decision model was most sensitive to disease prevalence. As provider expertise increased, the additional cost of an additional correct diagnosis increased for ERCP compared with MRCP-ERCP, with disease prevalence accentuating provider effects. CONCLUSION: Initial EUS and initial MRCP are less costly than initial ERCP, but provider expertise, biliary disease prevalence, and procedural costs influence incremental cost-effectiveness.

Biliary Tract Diseases↗
PubMed2003

Intrasphincteric botulinum toxin versus pneumatic balloon dilation for treatment of primary achalasia.

GOALS: Despite a high success rate, pneumatic dilatation for achalasia is accompanied by a significant risk of esophageal perforation. Injection of botulinum toxin (botox) into the lower esophageal sphincter (LES) can lead to improvement in symptoms with reduced risk of complications. Direct comparisons of the two techniques are needed to define their role in clinical management. STUDY: We compared pneumatic dilatation to botox for patients with achalasia using a double blind, randomized study design. Patients underwent clinical, manometric, radiographic and endoscopic evaluation to confirm primary achalasia. They were randomized to receive either 80 units of botox into the LES or Witzel balloon dilatation. Patients also received sham dilatation or injection, respectively. The patients and investigators assessing symptom response were blinded to therapy. Symptoms and esophageal function were assessed at 3 weeks, 3 months and 1 year after therapy. Treatment failure was defined as the lack of decrease in symptom grade more than 1 or recurrence of symptoms. Patients with treatment failure crossed over to the alternative treatment. RESULTS: Thirty four patients were studied, and 31 completed the trial. Of the 18 patients randomized to Witzel dilatation, 16 (89%) of 18 remained in clinical remission. Of the two patients with treatment failure, one responded to botox injection. Of the 16 patients randomized to botox, (38%) 6 of 16 remained in clinical remission. Four patients had initial failure, and 6 relapsed at a mean of 4 months after therapy. Of the nine patients who crossed over to dilatation, seven responded well, but two required surgical management of perforation. Although both treatments had excellent initial clinical improvement, patients randomized to Witzel dilatation had superior long-term success ( < 0.01). CONCLUSION: Initial therapy with Witzel dilatation is associated with better long-term outcome than a single injection of botox. Because of the risk of endoscopic perforation, botox remains a viable alternative to dilatation.

Anti-Dyskinesia Agents↗
PubMed2002

Role of initial NSAID choice and patient risk factors in the prevention of NSAID gastropathy: a decision analysis.

OBJECTIVE: To investigate the role of initial nonsteroidal antiinflammatory drug (NSAID) choice in the prevention of NSAID gastropathy, based on relative clinical and economic effects. METHODS: To mimic clinical practice, a symptom-driven decision analytic model was constructed to compare 2 treatment strategies for long-term users of NSAIDs over a 1-year period: Strategy 1-generic NSAID used initially, and safer, more expensive NSAID reserved for treatment failures due to symptomatic gastropathy; and Strategy 2-safer, more expensive NSAID used in all instances. The only distinction between the strategies was the choice of initial NSAID. NSAIDs differed in gastrointestinal safety profiles and acquisition costs. The use and impact of antisecretory medications were included in the model. Because published data on patients' ulcer risk and relative NSAID safety show considerable variability, sensitivity analyses were used to evaluate the key clinical outcomes and costs. RESULT: For patients without risk factors for NSAID ulcers (average risk), the model estimated that the strategy restricting use of the safer NSAID resulted in more symptomatic ulcers (Strategy 1, 2.58; Strategy 2, 0.73) and ulcer-related complications (Strategy 1, 1.18; Strategy 2, 0.23) per 100 patient years. The restricted strategy led to a significantly lower cost per patient treated (Strategy 1, $239; Strategy 2, $831 per year). In the principal analysis, the incremental costs to prevent symptomatic and complicated ulcers were $31,900 and $56,700, respectively. The estimated incremental cost per ulcer avoided was sensitive to the relative protection provided by the safer NSAID and fell dramatically as the patients' ulcer risk was increased above average risk. CONCLUSION: Unrestricted use of NSAIDs that reduce the risk of symptomatic ulcers has the potential to produce important clinical benefits at incremental cost. The impressive impact of ulcer risk on the incremental cost per ulcer prevented warrants increased attention to risk factor identification when NSAIDs are prescribed.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2002

Nonmucinous cystic pancreatic neoplasms.

This article discusses serous cystadenomas, the most common of the nonmucinous cystic lesions of the pancreas. These microcystic lesions were previously known as "glycogen-rich" cystadenomas because of the presence of glycogen within the cyst epithelium. A small percentage of these lesions are macrocystic, and it may be difficult to differentiate them from mucinous lesions; however, endoscopic ultrasound guided fine needle aspiration can provide diagnostic material from the cyst fluid. The second most common nonmucinous cyst, the islet cell tumor, is also discussed. These rare cystic tumors may or may not be accompanied by excess hormone production. The prognosis for the rare cystic tumors is good if they are resected successfully.

Adenoma, Islet Cell↗
PubMed2002

Initial experience with an electronic radial array echoendoscope: randomized comparison with a mechanical sector scanning echoendoscope in humans.

BACKGROUND: An electronic radial array echoendoscope has been developed that uses the same US processor as the linear array instruments made by the same company, thereby eliminating the need for two processors. The performance of this prototype instrument was compared with that of a mechanical radial echoendoscope in patients. METHODS: Fourteen patients underwent sequential examinations with both echoendoscopes in random order. Predefined criteria were used to evaluate the performance of each instrument. RESULTS: The quality of the electronic radial image was rated as "good" or "superior" to that of the mechanical radial echoendoscope in 12 patients. In 2 patients, imaging with the prototype was inferior because of positioning and/or operator inexperience. The forward-viewing optics of the prototype enhanced intubation and instrument advancement. Limitations included excessive stiffness of the tip of the instrument that resulted in occasional slippage from the duodenum. The prototype provided an adequate diagnosis in 12 patients and was superior to the mechanical radial endoscope in terms of diagnosis in 2 cases. CONCLUSION: The prototype electronic radial echoendoscope provides US images of similar quality and is equivalent in terms of clinical utility to the mechanical radial echoendoscope.

Adult↗
PubMed2002

Helicobacter pylori test-and-treat intervention compared to usual care in primary care patients with suspected peptic ulcer disease in the United States.

OBJECTIVES: [corrected] The Helicobacter pylori (H. pylori) "test-and-treat" strategy in uninvestigated dyspepsia is an effective alternative to prompt endoscopy. Our aims were to determine whether the combination of an educational session and availability of office-based H. pylori testing (test-and-treat intervention [TTI]) increases use of the test-and-treat strategy by primary care practitioners and whether it improves patient outcomes. METHODS: We conducted a 1-yr prospective trial of patients with suspected peptic ulcer disease in six primary care centers, three with TTI and three designated as usual care controls (UCC). RESULTS: H. pylori testing was performed in 81% of 54 TTI patients and in 49% of 39 UCC patients (p = 0.004). TTI and UCC patients had similar gastroenterology referral rates (24% vs 33%, p = 0.33), endoscopy or upper GI radiography rates (30% vs 31%, p = 0.91), and primary care visits per patient (3.1 +/- 2.8 vs 3.1 +/- 2.6, p = 0.92). TTI patients were less likely than UCC patients to receive repeated antisecretory medication prescriptions (35% vs 66%, p = 0.003). Symptomatic status at 1 yr and satisfaction with medical care did not differ between groups. Median (and interquartile range) annualized disease-related expenditures per patient were $454 ($162-932) for TTI and $576 ($327-1,435) for UCC patients (p = 0.17). CONCLUSIONS: The combination of an educational session and availability of office-based H. pylori testing may increase acceptance of the test-and-treat strategy by primary care providers. It remains to be determined whether increased use of the test-and-treat strategy yields significant improvements in clinical and economic outcomes compared to usual care.

Adult↗
PubMed2002

Outcomes studies of the gastrointestinal safety of cyclooxygenase-2 inhibitors.

Short-term endoscopic studies of the highly selective cyclooxygenase-2 (COX-2) inhibitors (coxibs) rofecoxib and celecoxib have shown that these agents are well tolerated and have efficacy equivalent to nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) with fewer adverse effects on the upper gastrointestinal (GI) tract. These studies are limited, however, as the detection of endoscopic lesions is not well correlated with symptomatic ulcers and ulcer complications. Outcomes studies of the GI safety are, therefore, essential to understanding how coxibs are likely to perform in a clinical practice setting. Four large outcomes studies (Vioxx Gastrointestinal Outcomes Research, VIGOR; Assessment of Difference Between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness trial, ADVANTAGE; Celecoxib Long-term Arthritis Safety Study, CLASS; and the Successive Celecoxib Efficacy and Safety Studies, SUCCESS) examined the GI safety of rofecoxib and celecoxib in over 39,000 patients with osteoarthritis or rheumatoid arthritis. Results of these studies showed that patients taking a supratherapeutic dose of rofecoxib or celecoxib had significantly lower rates of GI-related adverse events than those taking a nonselective NSAID (naproxen, ibuprofen, or diclofenac). Reduced risk of upper GI events was seen in patients with multiple risk factors and in patients using low-dose aspirin and corticosteroids concomitantly with a coxib. Results of large outcomes studies provide support for the COX-2 hypothesis and demonstrate the long-term safety and tolerability of coxibs.

Arthritis↗
PubMed2002

Gastrointestinal outcomes: evidence for risk reduction in patients using coxibs.

This paper examines the importance of clinically relevant gastrointestinal (GI) outcomes in patients using nonsteroidal anti-inflammatory drugs (NSAIDs) and the risk reduction for adverse GI events associated with cyclooxygenase (COX)-2-selective inhibitors. Four large outcomes trials are reviewed, 2 each with celecoxib and rofecoxib. The results of outcomes studies are consistent with randomized controlled trials and demonstrate that coxibs are associated with significant reductions in clinically relevant GI outcomes. The reductions are observed in patients without GI risk factors as well as in those at risk, suggesting that these drugs have the potential to improve outcomes for all patients requiring NSAIDs.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMedDate not supplied

Endoscopic ultrasound-guided fine needle aspiration of the pancreas. Diagnostic utility and accuracy.

OBJECTIVE: Endoscopic ultrasound-guided fine needle aspiration biopsy (EUS-FNAB) is regarded as a safe and reliable procedure for diagnosing and staging of pancreatic neoplasms. This study retrospectively evaluated both the diagnostic utility and accuracy of pancreatic EUS-FNABs and potential cytologic pitfalls when using Diff-Quik stain for on-site evaluation. STUDY DESIGN: Pancreatic EUS-FNABs performed between 1995 and 1998 were identified from the files of the Department of Pathology. All patients were studied via a linear-array ultrasound endoscope with an FNAB device. Immediate evaluation of the specimen by a pathologist using air-dried slides and Diff-Quik stain was done on all cases. An average of five passes (range, three to nine) were performed. Five cytologic categories were identified: nondiagnostic, benign, atypical, suspicious and malignant. EUS disease staging, histologic correlation and clinical follow-up were reviewed. RESULTS: Sixty-nine consecutive pancreative FNABs were evaluated in the study period. The patients comprised 38 females and 31 males with a mean age of 65 years (range, 36-83). Histologic correlation was available on 40 patients, and follow-up was available on the remaining 29. The cytologic diagnoses included: 31 malignant, 8 suspicious, 6 atypical, 20 benign and 4 nondiagnostic. Forty-three cases were true positive, 9 were true negative, 2 were false positive, and 11 were false negative. The overall sensitivity was 80% and specificity was 82%. CONCLUSION: The study showed that cytologic evaluation of pancreatic EUS-FNABs has 80% sensitivity and 82% specificity. False negative diagnosis was usually due to sampling error. A nondiagnostic cytologic diagnosis should be rendered in the absence of adequate sampling of a lesion. On-site cytologic evaluation of EUS-FNABs aids in guaranteeing specimen adequacy, and the pathologist should be trained to evaluate Diff-Quik-stained samples.

Adenocarcinoma↗