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Biomedical subjects

J H Lewis

Publications and source records attributed to J H Lewis.

At least 19 recordsLinked to original sources

Measuring the incremental cost of clinical cancer research.

PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute-sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.

Clinical Trials as Topic↗

Management of drug-induced liver disease.

The treatment and prevention of drug-induced liver injury starts with the recognition of hepatotoxicity at the earliest possible time so that the suspected drug can be discontinued expeditiously. Both liver enzyme monitoring and vigilance for signs of hypersensitivity involving the liver are useful strategies for many agents known to cause hepatocellular necrosis leading to liver failure. Specific antidotes to prevent or limit hepatic damage exist for only a few drugs, the most important being N-acetylcysteine for the treatment of acetaminophen hepatotoxicity. Corticosteroids are of unproven benefit in the setting of fulminant failure. Ursodiol may be helpful in instances of cholestatic injury. For other agents, supportive measures and the increasing use of liver-assist devices as well as emergency liver transplantation are available when drug injury evolves into irreversible liver failure. It is hoped that a better understanding of hepatotoxicity mechanisms will lead to the development of more specific and effective forms of therapy in the near future.

Acetaminophen↗

Management of partial segmental priapism.

We report the cases of 2 patients with partial segmental priapism. The patients presented with pain, a perineal mass, and proximal segmental corporal thrombosis. Treatment consisted of a proximal corpus cavernosal-spongiosum shunt. Diagnostic considerations, literature review, and treatment options are discussed.

Adult↗

Percutaneous liver biopsy: what is the current approach? Results of a questionnaire survey.

The technique of performing liver biopsy varies among physicians, even within the same practice. In an attempt to determine whether gastroenteroogists/hepatologists differ in their approach compared to radiologists, we surveyed a nearly equal number of physicians in the Washington, DC, USA, metropolitan area with respect to 26 variables. While the technique can vary considerably, relatively few differences were seen between the groups. Only about half of gastroenterologists and hepatologists use ultrasound guidance, a biopsy, gun, and conscious sedation; radiologists routinely used a biopsy gun and conscious sedation and rarely require an overnight stay.

Biopsy↗

Drug-induced liver disease.

This year's review is divided into several sections: the first describes drug withdrawals and new general reviews of drug-induced liver disease (DILD), including a review of a classification of drug injury. We review agents newly described as causing DILD, and new reports of DILD from established agents appearing in the year 2000. New aspects regarding the treatment of acetaminophen toxicity are included, and in the final section we deal with prevention of DILD as well as issues surrounding the use of potentially hepatotoxic medications in patients with underlying chronic disease.

Journal Article↗

Urine drug screens in overdose patients do not contribute to immediate clinical management.

A prospective study assessed whether routine urine drug screens might alter the management of overdose patients. Urine was collected from 107 patients with a diagnosis of deliberate self-poisoning seen in the emergency department (ED) of a teaching hospital. The mean age of patients was 36 years (range 13-86 years) and 64% were female. All patients recovered after standard investigations and management, which did not include knowledge of urinary drug screen results. Two hundred ninety-seven compounds were detected in the 107 urine samples. Twenty percent were drugs administered in the ED. Sixty-five percent of patients were found to have taken more than one drug. Benzodiazepines were detected in 18% of samples, paracetamol in 10%, and alcohol in 8%. Sixty-one drugs, in 35 people, were identified that the patients did not report taking. Of these, paracetamol (10), benzodiazepines (9), and tetrahydrocannabinol (8) were the most common. All patients in whom paracetamol was found had already had paracetamol detected in blood and appropriate management instituted. If the results of urine screening had been immediately available this would not have affected the management or outcome of any patient.

Adolescent↗

Drug-induced liver disease.

The incidence of drug-induced liver disease appears to be increasing, reflecting the increasing number of new agents that have been introduced into clinical use over the past several decades. Among the topics covered, the author discusses incidence, diagnosis, risk factors, clinical presentations, hepatitis, and vascular injury. The author also reviews the hepatic injury seen with commonly prescribed drugs, emphasizing newer developments in the field and recent publications and reports.

Acetaminophen↗

Gastrointestinal and hepatic disorders in end-stage renal disease and renal transplant recipients.

Gastrointestinal and hepatic disorders are commonly associated with end-stage renal disease, hemodialysis, and renal transplantation. Recent studies indicate that the prevalence of dyspepsia, ulcer disease, and Helicobacter pylori gastritis is not significantly different from the general population. Bleeding from angiodysplasia, however, is more common in chronic renal failure, as is gastroparesis. The prevalence of chronic hepatitis B has been dramatically reduced among hemodialysis patients since the advent of universal precautions. Response rates to hepatitis B vaccine in noninfected patients, however, are lower in these individuals. Chronic hepatitis C is found in 20% to 25% of HD patients worldwide and accounts for approximately 1% of all infected individuals. Levels of alanine aminotransferase and aspartase aminotransferase are often within normal limits but may be elevated compared with a patient's preinfection levels. Dialysis has been shown to reduce the level of hepatitis C virus viremia. Treatment is similar to non-renal failure patients, although interferon is generally not used in renal transplant recipients owing to concerns of graft failure.

Gastrointestinal Diseases↗

Drug-induced liver disease.

This year's review has been divided into five sections: The first describes the natural history of drug-induced liver disease, the second discusses the issue of placebo-related increases in liver-associated enzymes, the third describes agents newly reported to cause hepatic injury, the fourth discusses new reports of hepatic injury from established drugs, and the final section reviews the burgeoning field of hepatoprotection with clinical and experimental examples of agents used in the prevention and treatment of drug-induced liver disease, with acetaminophen as the major example.

Journal Article↗

The role of the NP in the diagnosis and management of erectile dysfunction.

Erectile dysfunction (ED) affects approximately 30 million men, significantly affecting their quality of life and relationships. More and more men are seeking help for this problem due to the advent of simpler, less-invasive treatment options. Inevitably, nurse practitioners (NPs) in primary care will encounter patients with ED. The assessment and diagnosis of ED can be facilitated by using a structured decision-making approach, which will promote comprehensive patient care. Some primary care NPs may need to increase their own comfort level with taking a sexual history, evaluating sexual problems, and knowing when to refer to a specialist.

Erectile Dysfunction↗

Increased hepatic iron deposition resulting from treatment of chronic hepatitis C with ribavirin.

Increased levels of hepatic iron may impair the response of patients with chronic hepatitis C to treatment with interferon-alfa, but combination therapy with ribavirin has demonstrated efficacy in the treatment of hepatitis C. When used alone or with interferon-alfa, ribavirin may cause a dose-dependent reversible hemolytic anemia. We compared the extent and cellular localization of iron deposition in liver tissue from biopsy specimens obtained before and after 36 weeks of therapy with ribavirin or placebo for 59 patients with chronic hepatitis C. Paired slides were available for review from 26 ribavirin and 27 placebo recipients. Iron deposition was assessed using coded slides stained with Perls Prussian blue and was semi-quantitated in hepatocytes, Kupffer cells, and areas of fibrosis. The overall iron score fell by 0.96 in the placebo group and increased 1.69 in the ribavirin recipients. Iron was deposited mainly in hepatocytes; the hepatocyte iron score increased from 2.19 to 3.81 in the ribavirin group. The amount of iron staining in Kupffer cells declined in the placebo group and increased slightly in the ribavirin group. Iron changes in areas of fibrosis were minor and did not differ between groups. Increased total hepatic iron deposition occurred during a 9-month course of ribavirin. Ribavirin-associated hemolysis deposits iron preferentially in hepatocytes. This increased deposition of hepatic iron does not seem to affect the biochemical or histologic response to ribavirin therapy but may have implications for hepatocyte susceptibility to future injury.

Alanine Transaminase↗

Insights into the management of erectile dysfunction: Part II.

For the estimated 30 million men in the United States with erectile dysfunction (ED), treatment options are varied. What may be the best choice for one individual is not necessarily the right choice for someone else. It is essential that health care professionals have a thorough understanding of all available options so they can help their patients and partners make the best treatment choice for successful sexual satisfaction. A variety of available ED treatment options are outlined here.

Erectile Dysfunction↗

Mechanisms of inward-rectifier K+ channel inhibition by tertiapin-Q.

Tertiapin-Q (TPN(Q)) is a derivative of honey bee toxin tertiapin (TPN) whose methionine residue is replaced with a glutamine residue. TPN(Q) inhibits the ROMK1 and GIRK1/4 inward-rectifier K(+) channels with affinities very similar to TPN. However, unlike native TPN, TPN(Q) is nonoxidizable by air. The stability of TPN(Q) allows us to investigate how it interacts with the targeted channels. We found that the interaction between TPN(Q) and the ROMK1 channel is a bimolecular reaction, i.e., one TPN(Q) molecule binds to one channel. The interaction surface in TPN(Q) is primarily formed by its alpha helix rather than the beta sheets with which scorpion toxins form their interaction surface. The mutagenesis studies on both the channel and TPN(Q) together strongly suggest that to block the K(+) pore TPN(Q) plugs its alpha helix into the vestibule of the K(+) pore, while leaving the extended structural portion sticking out of the vestibule into the extracellular media.

Alanine↗

Investigation of multidrug-resistant Salmonella serotype typhimurium DT104 infections linked to raw-milk cheese in Washington State.

CONTEXT: Multidrug-resistant Salmonella Typhimurium DT104 has recently emerged as a cause of human and animal illness in Europe and North America. In early 1997, health officials in Yakima County, Washington, noted a 5-fold increase in salmonellosis among the county's Hispanic population. OBJECTIVES: To characterize bacterial strains and identify risk factors for infection with Salmonella Typhimurium in Yakima County. DESIGN: Laboratory, case-control, and environmental investigations. SETTING AND PARTICIPANTS: Patients with culture-confirmed Salmonella Typhimurium infection living in Yakima County and age- and neighborhood-matched control subjects. MAIN OUTCOME MEASURES: Food vehicle implication based on case-control study and outbreak control. RESULTS: Between January 1 and May 5, 1997, 54 culture-confirmed cases of Salmonella Typhimurium were reported. The median age of patients was 4 years and 91% were Hispanic. Patients reported diarrhea (100%), abdominal cramps (93%), fever (93%), bloody stools (72%), and vomiting (53%); 5 patients (9%) were hospitalized. Twenty-two patients and 61 control subjects were enrolled in the case-control study. Seventeen case patients (77%) reported eating unpasteurized Mexican-style soft cheese in the 7 days before onset of illness compared with 17 control subjects (28%) (matched odds ratio, 32.3; 95% confidence interval, 3.0-874.6). All case-patient isolates were phage definitive type 104 (DT104) (n = 10) or DT104b (n = 12), and 20 (91%) were resistant to ampicillin, chloramphenicol, streptomycin, sulfamethoxazole, and tetracycline. The cheese produced and eaten by 2 unrelated patients was made with raw milk traced to the same local farm. Milk samples from nearby dairies yielded Salmonella Typhimurium DT104. The incidence of Salmonella Typhimurium infections in Yakima County returned to pre-1992 levels following interventions based on these findings. CONCLUSIONS: Multidrug-resistant Salmonella Typhimurium DT104 emerged as a cause of salmonellosis in Yakima County, and Mexican-style soft cheese made with unpasteurized milk is an important vehicle for Salmonella Typhimurium DT104 transmission. We postulate that recent increases in human salmonellosis reflect the emergence of Salmonella Typhimurium DT104 among dairy cows in the region. Continued efforts are needed to discourage consumption of raw milk products, promote healthier alternatives, and study the ecology of multidrug-resistant Salmonella Typhimurium.

Adolescent↗