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PubMed2004

Comparison of hospitalization rates in patients with community-acquired pneumonia treated with telithromycin for 5 or 7 days or clarithromycin for 10 days.

AIMS: To compare the impact on hospitalization rates and the clinical efficacy of oral telithromycin and clarithromycin treatment in patients with community-acquired pneumonia (CAP). METHODS: A total of 581 patients with CAP were enrolled in this randomized, double-blind, parallel group, multinational study, of whom 575 were evaluated for healthcare resource utilization from a payer perspective (intent to treat [ITT] population). Patients received telithromycin 800 mg once daily for 5 (n = 193) or 7 (n = 195)days, or clarithromycin 500 mg once daily for 10 days (n = 187). The primary efficacy endpoint was clinical outcome at test of cure (Days 17-24) in the per-protocol population. Frequency of CAP-related hospitalizations, physician visits/tests/procedures, and additional respiratory tract infection-related antibacterial use were compared by treatment group (ITT) up to late post- for clarithromycin vs dollars 37930 (difference: -26446; therapy (Days 31-36). Study investigators blinded to treatment assessed whether hospital admissions were CAP-related or not. CAP-related hospitalization costs (USdollars) for telithromycin and clarithromycin were compared. RESULTS: Clinical cure rates were similar in patients who received clarithromycin for 10 days and telithromycin for 5 or 7 days: 91.8% (134/146), 89.3% (142/159), and 88.8% (143/161), respectively, and both 5- and 7-day telithromycin were statistically equivalent to clarithromycin (difference: -2.5 and -3.0%, respectively; 95% CI: -9.7, 4.7 and -10.2, 4.3, respectively). There were 7 CAP-related hospital admissions among clarithromycin patients vs 3 (p = 0.283) and 1 (p = 0.021) admissions among 5- and 7-day telithromycin patients, respectively. The number of hospital days/100 patients was 40.1 for clarithromycin vs 17.1 and 7.2 for 5- and 7-day telithromycin, respectively. Projected hospitalization costs/100 patients were dollars 86205 95% CI: -66 654; 13 762) and dollars 16 091 (difference: -37 847; 95% CI: -77953; 2259) for 5- and 7-day telithromycin, respectively. CONCLUSIONS: Data from this study demonstrate that telithromycin 800 mg once daily for 5 or 7 days with fewer hospital days and potentially lower is an effective treatment for CAP,and that telithromycin treatment of CAP may be associated hospitalization costs than clarithromycin treatment.

Administration, Oral↗
PubMedDate not supplied

Nursing assessment of sexual function following permanent prostate brachytherapy for patients with early-stage prostate cancer.

Assessment of sexual function following potentially curative local treatment for carcinoma of the prostate gland has resulted in wide ranges of potency preservation rates, which may be because of differences in the evaluated patient populations, mode of data collection, and length of patient follow-up. Quality-of-life data are most reliable when obtained by patient-administered and validated quality-of-life instruments. In the Schiffler Cancer Center's prostate brachytherapy unit, healthcare professionals utilize the specific erectile questions of the International Index of Erectile Function to ascertain pre- and post-treatment erectile function. Documentation of sexual function following all local treatments, including prostate brachytherapy, may help to clarify the etiology of treatment-induced erectile dysfunction (ED), improve treatment for ED, and, ultimately, improve quality-of-life outcomes. Fortunately, the majority of patients with brachytherapy-induced ED respond favorably to sildenafil citrate.

Adenocarcinoma↗
PubMed2004

Economic endpoints in clinical trials.

Healthcare decision makers are increasingly requesting information on the cost and cost-effectiveness of new medicines at the time of product launch. In order to provide this information, data on healthcare resource utilization and, in some cases, costs, may be collected in clinical trials. In this paper, we discuss some of the issues statisticians need to address when it is appropriate to include these economic endpoints in the trial. Several design issues are discussed, including the alternative types of and methods for collecting economic endpoint data, sample size and generalizability. Alternative approaches in the analysis of resource utilization, cost and cost-effectiveness are also presented. Finally, several of the analytic approaches are applied to actual data from a clinical trial.

Clinical Trials as Topic↗
PubMed2004

Sociodemographic profile of insomniac patients across national surveys.

INTRODUCTION: A survey of 2121 insomniac patients was conducted in France, Germany, Italy and the United Kingdom. DESIGN: The survey collected data on the sociodemographic and clinical features of the subjects by interview, as well as on healthcare resource utilization. A complementary analysis of physician attitudes to insomnia provided insights into the types of treatment prescribed and expectations of medical treatment. RESULTS: Slightly more women than men reported insomnia, but the difference was not significant. The age distribution of insomniac patients varied from country to country. Insomnia was more frequent in the unemployed and in those individuals living alone. The most frequently cited causes of insomnia were stress, loneliness and bereavement. Insomnia was usually reported as chronic, and frequently as episodic. Frequently cited symptoms were poor sleep quality, interrupted sleep, early awakening, difficulties in getting to sleep and daytime fatigue. CONCLUSIONS: Many individuals hesitate to consult their doctor about insomnia, whereas physicians question their patients about possible sleep problems relatively infrequently and systematically underestimate the severity of insomnia and the resulting functional impairment. Physicians frequently recommended lifestyle changes and sleep hygiene measures to patients complaining of insomnia. Hypnotic agents were the most frequently prescribed class of medication. Patient satisfaction with treatment was relatively high.

Adult↗
PubMed1994

IS: the neural nexus. Why you should consider information systems as the central nervous system of an integrated healthcare network.

Until now, utilization of information systems in America's healthcare industry has been anything but scientific. And individual healthcare providers have managed to deliver the world's best healthcare services despite lousy information systems, lack of clinical outcomes data, lack of adequate service costing data and lack of customer satisfaction data. The key to the scientific improvement of the health status of a community health network is the acquisition and application of knowledge, which we believe to be wholly dependent upon scientifically designed clinical information systems. We've got some work to do.

Comprehensive Health Care↗
PubMed1998

The pharmacoeconomic benefits of cholesterol reduction.

Recent studies show that cholesterol-lowering therapy can reduce morbidity and mortality in hypercholesterolemic patients without preexisting coronary heart disease (primary prevention) and with coronary heart disease (secondary prevention). The high cost of treatment per event prevented, especially for primary prevention, raises concerns about widespread use of cholesterol-lowering therapy. Does cholesterol reduction reduce utilization of healthcare resources, and can society afford to pay for reducing cholesterol in all patients with hypercholesterolemia, irrespective of risk factors? Is cost-effectiveness of therapy affected by differing cholesterol levels, age of the patients, the duration of therapy, or the presence of risk factors? Current pharmacoeconomic studies support the use of the statins for secondary prevention, and primary prevention in high-risk patients, and provide key information for policy decision making in the treatment of patients with hypercholesterolemia.

Cholestyramine Resin↗
PubMed1998

Safety and clinical efficacy of zileuton in patients with chronic asthma.

Zileuton, a leukotriene pathway inhibitor used to treat asthma, improves lung function, relieves symptoms, and is well tolerated. The purpose of this 12-month, parallel-group, open-label study was to assess the efficacy of zileuton and evaluate liver function in patients treated with this drug (approximately 2% of patients treated with zileuton in controlled trials had reversible liver enzyme elevations). A total of 2,947 patients at 233 centers in the United States were randomly assigned in a 5:1 ratio to treatment with zileuton plus usual asthma care or usual asthma care alone. Efficacy variables included asthma exacerbations; need for alternative treatment, steroid rescue, emergency care, and hospitalizations; forced expiratory volume in 1 second (FEV1); and asthma symptom scores. The safety evaluation included measurement of alanine aminotransferase levels. Patients treated with zileuton had significantly fewer corticosteroid rescues (P < 0.001), required less emergency care (P < 0.05), had fewer hospitalizations, and had greater increases in FEV1 (P = 0.048). They also had significantly greater improvements in asthma symptoms. Increases in alanine aminotransferase levels to three times or more the upper limit of normal occurred in 4.6% of patients treated with zileuton and 1.1% of those receiving usual care (P < 0.001); most increases occurred during the first 2 to 3 months. Alanine aminotransferase levels decreased to less than two times the upper limit of normal or to baseline levels during zileuton treatment or after drug cessation. Jaundice or chronic liver disease did not develop in any patient. Adding zileuton to the therapeutic regimens of patients with asthma is likely to improve asthma control and lower utilization of healthcare resources.

Asthma↗
PubMed1999

Will I make it through this choppy water? A psychological characteristic as a predeterminant factor to coping with multiple sclerosis.

The ability to cope with major stressors and adversity in our lives is as individual as the human experience. An unpredictable disease such as Multiple Sclerosis (MS) can demand major adjustments to one's lifestyle, employment, and personal relationships. Why is it that some sail smoothly through major upheaval in all of these realms despite the acquisition of significant physical disability while others are immobilized by seemingly trivial disruptions in their routine. How can we, as health professionals, assist those who are coping in a non-adaptive manner, to identify and implement more effective strategies. Does focused counseling early in the disease promote effective coping? Existing literature reviews coping with chronic illness, detailing the tools and strategies which individuals may use to manage stressors. This paper will build on this foundation of knowledge. How well you are determines how well you cope. The emphasis will be on "premorbid" personality traits which may be critical to coping. The author will critically examine the practicality of utilizing existing assessment tools for those at differing stages of MS and offer assessment guidelines for nurses working both with newly diagnosed and well-established disease. Suggestions for counseling techniques which may promote effective coping behaviors will be offered. How an individual copes with a chronic illness such as MS has implications for that person's family, social network and society at large. Those who become overwhelmed by a disease such as MS will stop working earlier, utilize more healthcare resources, and rate themselves as having poor quality of life. Nurses and other health professionals who have regular contact with those with MS may be able to influence this scenario.

Adaptation, Psychological↗
PubMed2000

The futility of common firewall policies: an experimental demonstration.

Many healthcare organizations utilize network "firewalls" to protect their networks from being accessed by unauthorized external entities. These same firewalls are also often configured to deny access to certain external services from within the internal network. The latter policy can be subverted through a "protocol tunneling" strategy, which has been implemented as a set of programs called "Firehole." Organizations should be aware of this potential weakness in their network security designs. Policies that deny external services to users should be carefully evaluated in light of clearly defined organizational goals.

Computer Communication Networks↗
PubMed2000

Determinants of antidepressant treatment outcome.

OBJECTIVE: To understand the determinants of the outcome of an episode of major depression, including factors that affect receipt of guideline-consistent care and their subsequent effect on treatment outcomes, particularly relapse or recurrence. Results of previous studies are generalized to a population typical of depressed individuals in the United States, i.e., a cohort of antidepressant users with employer-provided health benefits. STUDY DESIGN: A quasi-experimental design was used to assess the determinants of the outcome of an episode of major depression. Healthcare utilization-based measures of treatment characteristics and outcomes were used. PATIENTS AND METHODS: The final analytical file for this study contained data on 2917 patients who had an antidepressant prescription associated with an indicator of a depressive disorder. We identified relapse or recurrence of depression by (1) a new episode of antidepressant therapy, (2) suicide attempt, (3) psychiatric hospitalization, (4) mental health-related emergency department visits, or (5) electroconvulsive therapy. Antidepressant use patterns were used to construct a measure for adherence to treatment guidelines. Multivariate Cox proportional hazard and logit regression models were used to predict relapse/recurrence and adherence with treatment guidelines, respectively, for each patient. RESULTS: Factors that affect relapse/recurrence include comorbidities, demographics, and adherence to treatment guidelines. Factors that affect adherence to treatment guidelines include choice of initial antidepressant drug, comorbidities, psychotherapy, and frequency of physician visits. CONCLUSIONS: Adherence to treatment guidelines was associated with a significant reduction in the likelihood of relapse or recurrence of depression. Choice of initial antidepressant drug affects adherence to treatment guidelines.

Antidepressive Agents↗
PubMed2000

Targeting remodeling in respiratory inflammation.

Chronic asthma causes considerable morbidity, mortality and utilization of healthcare resources. The fact that asthma still causes such problems despite the widespread use of anti-inflammatory treatment suggests that new approaches are needed. Airways in chronic asthma are characterized by considerable remodeling which affects a number of structures, particularly airway smooth muscle and changes in airway smooth muscle thickness may be one of the most important determinants of bronchial hyperresponsiveness. Here we suggest new approaches that might be used to target smooth muscle remodeling in asthma.

Animals↗
PubMed2003

[Management of pediatric asthma].

Bronchial asthma, in adults and children, is a major health problem, with prevalence rates ranging from 4% to 7% in western Europe. Observational studies suggest that in Italy, like in the other countries, asthma is poorly controlled: most patients report frequent symptoms and limitation to daily activities; the utilization of healthcare resources (hospitalization, emergency room visits, unscheduled urgent care visit) is high. Recent international guidelines (GINA) for asthma management, together with an up-date by NIH, point to the primary role of inhaled corticosteroids for the control of the disease. Early interention with anti-inflammatory drugs is important, also in pre-school children with frequent or persistent symptoms, in order to prevent irreversible structural alterations of the airways and to improve long-term prognosis. In the presence of more severe asthma, inhaled corticosteroids can be associated with long-acting beta2-agonists bronchodilators. These 2 drug classes target different and complementary aspects of the pathophysiology of asthma (inflammation and bronchial obstruction) in a synergistic manner, i.e. by mutual potentiation of their pharmacological activity. Thus, combination therapy may optimize beneficial actions, allowing a more effective control of asthma.

Asthma↗
PubMed2004

Risk classification of Medicare HMO enrollee cost levels using a decision-tree approach.

OBJECTIVE: To determine whether classification tree techniques used on survey data collected at enrollment from older adults in a Medicare HMO could predict the likelihood of an individual being in a low, medium, high, or very high cost group in the subsequent year. METHODS: Data from comprehensive health risk assessment (HRA) screening of 11 744 new enrollees (age > or = 65 years) continuously enrolled in a Medicare HMO for at least 24 months between 1997 and 2002 were combined with complete healthcare service utilization data for each enrollee in the postenrollment period to create cost groups. An original clinically devised algorithm and a Classification and Regression Tree (CART) that used the HRA data were compared with respect to their ability to correctly place an individual within the cost groups over 12 months of enrollment. RESULTS: The variables that best classified enrollees into 12-month cost groups included quality of life, age, and preenrollment health services. Classification was best for CART: a sensitivity of 39.8% and a specificity of 83% was achieved for very high cost enrollees. Compared with the clinical algorithm, CART also utilized only one third as many predictor variables to define risk categories. CONCLUSION: Brief self-report survey data collected at enrollment can be modeled to provide moderate sensitivity in predicting very high costs in the postenrollment year. The ease of applicability of software to create empirically derived profiles of high-cost enrollees precludes the need to rely on clinically devised algorithms to identify enrollees at risk for very high costs.

Aged↗
PubMed2004

[Progress in endoscopic antireflux procedures].

Gastroesophageal reflux disease (GERD) is a widespread morbid condition that adversely affects quality of life and results in great utilization of healthcare resources. Recently medical therapy has improved with the introduction of the proton pump inhibitors, but patients must take medicine rather indefinitely often on a daily basis. Surgical therapy with the application of laparoscopic fundoplication has improved too, but still is associated with invasiveness and morbidity. Now third option has emerged--endoscopic antireflux procedures. Three novel forms of endoscopic procedures are under development: plication of the gastroesophageal junction by endoscopic suturing, thermoablation of the muscle of lower esophageal sphincter and gastric cardia (the Stretta procedure), endoscopic implantation of a biopolymer (Enteryx). These procedures seem effective and rather safe, but they are in the early stages of development and the magnitude of their efficacy is yet undetermined. It is necessary to validate these methods and assess safety by long-term placebo-controlled studies.

Endoscopy↗
PubMed2004

Pain following herpes zoster: implications for management.

At the 11th Annual Meeting of the International Herpes Management Forum (IHMF), held 27-29 February 2004, I delivered the Martin Wood Memorial Lecture on the management of herpes zoster-associated pain. Prevention of post-herpetic neuralgia is an important goal in the management of herpes zoster. Recognition of individuals at high risk of progression, followed by prompt intervention with antiviral agents, helps to reduce the disability, distress and healthcare resource utilization caused by this disease and its consequences. In established cases of post-herpetic neuralgia, first line therapy with tricyclic antidepressants and second line therapy with some anticonvulsants and opioids have both shown efficacy in many patients, but development of more effective treatments is needed for optimal outcomes.

Algorithms↗