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Biomedical subjects

J Hornberger

Publications and source records attributed to J Hornberger.

At least 19 recordsLinked to original sources
PubMed2006

The economics of treating chronic hepatitis C patients with peginterferon alpha-2a (40 kDa) plus ribavirin presenting with persistently normal aminotransferase.

Peginterferon alpha-2a (40 kDa) plus ribavirin is effective at achieving sustained viral response compared with no treatment in patients with chronic hepatitis C (CHC) and persistently normal aminotransferase levels (PNALT). The cost-effectiveness of treating CHC in the setting of PNALT has not been assessed. Disease progression in patients with PNALT was simulated in a Markov model. The rate of fibrosis progression, quality of life and costs for each health state were based on literature estimates. The perspective of the Italian National Health Service was adopted and costs (euro 2003) and benefits were discounted at 3%. Sensitivity analyses were performed on important parameters. The primary analysis compared combination therapy with peginterferon alpha-2a (40 kDa) plus ribavirin to no treatment in a cohort of patients with mean age 45 years, and was based on findings from a multinational, randomized trial in patients with PNALT. In genotype 1 patients, the risk of cirrhosis at 30 years is forecast to fall from 32% with no treatment to 19% with combination therapy, increasing quality-adjusted life years (QALYs) by 0.74 years at an incremental cost per QALY gained of euro 16,831. The 30-year risk of cirrhosis in genotype 2 or 3 is projected to fall to 9% with combination therapy, an increase in QALYs of 1.34 years, at an incremental cost per QALY gained of euro 3,000. Thus treatment of PNALT with peginterferon alpha-2a (40 kDa) plus ribavirin is projected to reduce the incidence of cirrhosis, increase life expectancy and have an acceptable cost-effectiveness ratio from a societal perspective.

Adult↗
PubMed2005

Cost-effectiveness of rituximab (MabThera) in diffuse large B-cell lymphoma in The Netherlands.

OBJECTIVE: To determine the incremental cost-effectiveness ratio (ICER) of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) vs. CHOP plus rituximab (R-CHOP) in diffuse large B-cell lymphoma (DLBCL) patients in the Netherlands. METHODS: A state transition model was developed to estimate the clinical course, costs and quality of life of patients with stage II, III or IV DLBCL receiving initial treatment with CHOP or R-CHOP to arrive at the ICER. The base year for the cost analysis was 2002 and was performed from the societal perspective. Only direct medical costs were included. The time horizon of the model was 15 yr and both costs and effects were discounted at 4%. Sensitivity analyses were performed to determine the effect of varying base-line assumptions of the model. RESULTS: The incremental gain in quality adjusted life years (QALYs) was 0.88 in both the younger and the older patient groups. The costs were 12 343 higher in the younger group of patients and 15 860 in the older patients. This resulted in an ICER of 13 983 for the younger and 17 933 for the older patients per QALY gained. These results were sensitive to the time horizon of the model, other variations had a marginal impact on the outcome. CONCLUSION: The addition of rituximab to standard therapy for DLBCL results in a gain of 0.88 QALYs. The ICER of 13 983 for younger and 17 933 for older patients per QALY gained should, seen in the light of disease severity, be considered acceptable by most policy makers in priority setting for budget allocation.

Antibodies, Monoclonal↗
PubMed2001

The sample size for a clinical trial: a Bayesian-decision theoretic approach.

Using decision theory, what is an appropriate sample size for a clinical trial, with a binary endpoint? We present a program, suitable for actual planning, which, with some extensions, implements Canner's solution to this question. Examples with a discussion are given. Implications of a Bayesian approach are discussed. Bayesian and Neyman--Pearson approaches are compared.

Bayes Theorem↗
PubMed2001

Introduction to Bayesian reasoning.

Interest in Bayesian analyses has increased recently, in part as a response to policy makers wanting sound scientific bases for health technology assessments, and associated healthcare funding decisions. This paper provides a brief and simplified description of Bayesian reasoning. Bayes is illustrated in a clinical setting of an expert helping a woman understand the potential risk of passing on an inheritable disease (hemophilia) to her next child, based on disease occurrence in two living children. The illustration describes fundamental concepts and derivations, such as Bayes theorem, likelihood functions, prior probability, and posterior probability. A second illustration shows the use of Bayes for interpreting clinical trial results. The uncertainty in the clinical effect before and after the trial analyses has been completed is characterized by the Bayes prior and posterior probabilities, respectively. Techniques are also shown for estimating the potential loss (e.g., in lives lost) for making the wrong decision with and without knowledge of the trial results, an estimation that cannot be carried out using techniques of hypotheses testing associated with the frequentist school of statistics. Information from Bayes analysis then may be used to help policy makers decide, or justify, whether the analyses provides a sufficient basis for making a treatment recommendation, or whether there remains a need to request more information. Subsequent papers in this volume offer additional examples and clarification of the use of Bayes in clinical practice and in interpretation of clinical studies.

Bayes Theorem↗
PubMed2000

A cost-effectiveness analysis of prescribing strategies in the management of gastroesophageal reflux disease.

OBJECTIVE: Patients who have uncomplicated gastroesophageal-reflux disease (GERD) typically present with heartburn and acid regurgitation. We sought to determine the cost-effectiveness of H2-receptor antagonists (H2RAs) and proton-pump inhibitors (PPIs) as first-line empiric therapy for patients with typical symptoms of GERD. METHODS: Decision analysis comparing costs and benefits of empirical treatment with H2RAs and PPIs for patients presenting with typical GERD was employed. The six treatment arms in the model were: 1) Lifestyle therapy, including antacids; 2) H2RA therapy, with endoscopy performed if no response to H2RAs; 3) Step up (H2RA-PPI) Arm: H2RA followed by PPI therapy in the case of symptomatic failure; 4) Step down arm: PPI therapy followed by H2RA if symptomatic response to PPI, and antacid therapy if response to H2RA therapy; 5) PPI-on-demand therapy: 8 wk of treatment for symptomatic recurrence, with no more than three courses per year; and 6) PPI-continuous therapy. Measurements were lifetime costs, quality-adjusted life years (QALYs) gained, and incremental cost effectiveness. RESULTS: Initial therapy with PPIs followed by on-demand therapy was the most cost-effective approach, with a cost-effectiveness ratio of $20,934 per QALY gained for patients with moderate to severe GERD symptoms, and $37,923 for patients with mild GERD symptoms. This therapy was also associated with the greatest gain in discounted QALYs. The PPI-on-demand strategy was more effective and less costly than the H2RA followed by PPI strategy or the other treatment arms. The results were not highly sensitive to cost of therapy, QALY adjustment from GERD symptoms, or the success rate of the lifestyle arm. However, when the success rate of the PPI-on-demand arm was < or =59%, the H2RA-PPI arm was the preferred strategy. CONCLUSION: For patients with moderate to severe symptoms of GERD, initial treatment with PPIs followed by on-demand therapy is a cost-effective approach.

Adult↗
PubMed1999

Patient preferences in coronary revascularization.

BACKGROUND: This study was performed to assess patient preferences for consequences of 3 coronary revascularization procedures: angioplasty, conventional coronary bypass surgery, and minimally invasive coronary bypass surgery. METHOD: A nationwide sample of 3 types of respondents was recruited: respondents with no heart disease (n = 89), respondents with heart disease who had not undergone cardiac surgery (n = 97), and respondents with heart disease who had undergone cardiac surgery (n = 118). RESULTS: Sixty-two percent ranked the risk of repeat revascularization as the most important concern, followed by postprocedure pain (22%), time to recovery of physical functioning (8%), time in hospital (4%), and body appearance (4%). Respondents preferred angioplasty to conventional and minimally invasive cardiac surgery if the 3-year risk of repeat revascularization with angioplasty were to decline to less than 28% and 21%, respectively. CONCLUSION: These data suggest that patient preference should influence individual and policy recommendations when choosing among coronary revascularization procedures.

Data Collection↗
PubMed1999

Effect of intradialytic parenteral nutrition on delivered Kt/V.

The purpose of the study is to determine the effect of intradialytic parenteral nutrition (IDPN) and its components on delivered Kt/V (Kt/Vd). Nineteen patients undergoing routine outpatient hemodialysis and receiving IDPN were enrolled onto this prospective, crossover study. To reduce the confounding of time, assigned treatment in the first week was random, with patient crossover in the fourth week. Patients served as their own controls. In the successive 6 weeks, patients received IDPN solutions differing in whether amino acids (AAs), dextrose, or lipids were included or excluded. The primary end point was Kt/Vd, measured with a single-pool, variable-volume urea kinetic model. Other factors with the potential to impact on Kt/Vd were controlled and/or monitored. The administration of IDPN with all three components resulted in a significantly reduced mean Kt/Vd. When patients received AA-containing solutions, mean Kt/Vd was significantly less than when IDPN was withheld. Administration of solutions without AA resulted in a mean Kt/Vd not significantly different from mean Kt/Vd when IDPN was withheld. The mean prescribed Kt/V did not differ from mean Kt/Vd when IDPN was withheld. Simulation analyses of increased urea generation (Gu) showed an increase in patient urea volume and decreased Kt/V similar to the study findings. AA-containing IDPN solutions resulted in a significant reduction in Kt/Vd, possibly mediated by increased Gu. Administration of IDPN solutions may have important clinical and economic consequences that warrant further investigation.

Aged↗
PubMed1999

Incidence and long-term cost of steroid-related side effects after renal transplantation.

Corticosteroids are an essential component of most immunosuppressive regimens currently used in renal transplantation because of their efficacy in reducing acute rejection and improving graft survival. Steroids, however, are associated with numerous side effects that lead to increased patient morbidity and mortality. The incidence and economic cost of steroid-related side effects have not been quantitatively assessed. Thus, based on a systematic review of the published literature, we estimated the incidence of steroid-related hypertension (15%), posttransplantation diabetes mellitus (10%), peripheral fractures (2% per year), avascular necrosis of the hip (8%), and cataracts (22%). In addition, we estimated that approximately 5% of patients who have cataracts or avascular necrosis of the hip require surgery. We used these literature-based estimates in a model to project the costs of treating side effects over a 10-year posttransplantation time frame for a 50-patient cohort that represented an average-sized renal transplant center. Steroid-induced hypertension and its complications were the most expensive side effect ($93,900), followed closely by posttransplantation diabetes ($89,700) and avascular necrosis of the hip ($61,700). Cataracts and peripheral bone fractures were less costly ($16,300 and $4,300, respectively). The cumulative projected 10-year cost of all side effects for the 50-patient cohort was $265, 900, or $5,300 per transplant patient. Steroid-related side effects add to the long-term cost of medical care of renal transplant recipients. These costs provide a rationale for further investigation of steroid-sparing immunosuppression protocols.

Adrenal Cortex Hormones↗
PubMed1999

Clustering and the design of preference-assessment surveys in healthcare.

OBJECTIVE: To show cluster analysis as a potentially useful tool in defining common outcomes empirically and in facilitating the assessment of preferences for health states. DATA SOURCES: A survey of 224 patients with ventricular arrhythmias treated at Kaiser Permanente of Northern California. STUDY DESIGN/METHODS: Physical functioning was measured using the Duke Activity Status Index (DASI), and mental status and vitality using the Medical Outcomes Study Short Form-36 items (SF-36). A "k-means" clustering algorithm was used to identify prototypical health states, in which patients in the same cluster shared similar responses to items in the survey. PRINCIPAL FINDINGS: The clustering algorithm yielded four prototypical health states. Cluster 1 (21 percent of patients) was characterized by high scores on physical functioning, vitality, and mental health. Cluster 2 (33 percent of patients) had low physical function but high scores on vitality and mental health. Cluster 3 (29 percent of patients) had low physical function and low vitality but preserved mental health. Cluster 4 (17 percent of patients) had low scores on all scales. These clusters served as the basis of written descriptions of the health states. CONCLUSIONS: Employing a clustering algorithm to analyze health status survey data enables researchers to gain a data-driven, concise summary of the experiences of patients.

Adult↗
PubMed1998

Risks and costs of end-stage renal disease after heart transplantation.

OBJECTIVES: To estimate the risks and costs of end-stage renal disease (ESRD) after heart transplantation. BACKGROUND: Previous studies have shown high rates of ESRD among solid-organ transplant patients, but the relevance of these studies for current transplant practices and policies is unclear. Limitations of prior studies include relatively small, single-center samples and estimates made before implementing suggested practice changes to reduce ESRD risk. METHODS: Medicare beneficiaries who underwent heart transplantation between 1989 and 1994 were eligible for study inclusion (n=2088). Thirty-four patients undergoing dialysis or who had the diagnosis of ESRD before or at transplantation were excluded from the study. ESRD was defined as any patient undergoing renal transplantation or requiring dialysis for more than 3 months. Mortality and ESRD events were recorded up to 1995. ESRD risk was estimated using the Kaplan-Meier product-limit estimator and logistic regression analyses. Linear regression was performed to determine expenditures for treating ESRD, and we developed long-term models of the risk and direct medical costs of ESRD care. RESULTS: The annual risk of ESRD was 0.37% in the first year after transplant and increased to 4.49% by the sixth posttransplant year. There was no significant trend in the risk of ESRD based on the year of transplantation, even after adjusting for patient characteristics. The average cumulative 10-year direct cost of ESRD per patient undergoing heart transplantation exceeded $13,000. CONCLUSIONS: In a large, national sample of patients undergoing heart transplantation, ESRD is not rare, even for patients undergoing transplant after the development of new practices intended to reduce its occurrence. ESRD remains an important component of the costs of heart transplantation.

Adult↗
PubMed1998

The cost-effectiveness of treating women with a cervical vaginal smear diagnosis of atypical squamous cells of undetermined significance.

OBJECTIVE: The purpose was to determine the optimal treatment protocol for women with a cervical vaginal diagnosis of atypical squamous cells of undetermined significance. STUDY DESIGN: By means of decision analysis, 8 strategies were compared in terms of cost, life expectancy, cost-effectiveness, and the number of cancers and complications from treatment. Data were obtained from the medical literature and the University of Iowa Hospitals and Clinics. RESULTS: Compared with more aggressive strategies, such as those that use immediate colposcopy, strategies featuring repeated smears were less expensive and carried fewer complications but had lower life expectancies per patient and more cancers. The strategy of repeating a smear annually had a lower cost per patient than did the other strategies, ranging from $112 to $989, and had a similar discounted life expectancy to that of the strategy with the longest discounted life expectancy. CONCLUSIONS: In most clinical scenarios strategies that used repeated smears were the most cost-effective.

Adult↗
PubMed1998

The cost-benefit of a randomized trial to a health care organization.

Clinicians and patients make many decisions in situations where optimal treatment is uncertain. Despite well-published advantages of clinical trials for reducing such uncertainties, a trial may not be conducted because the sample size indicated by classical, hypothesis-testing methods is so large that no one institution could afford to sponsor the trial. By explicitly taking into consideration the costs and benefits of a trial, Bayesian statistical methods permit estimation of the value to a health care organization conducting a randomized trial instead of continuing to treat patients in the absence of more information. This paper describes a method for calculating the cost-benefit to a health care organization conducting a clinical trial, and the expected sample size to adequately resolve the uncertainties about which treatment is better. The method is illustrated in the case of a proposed clinical trial of a drug to prevent multiorgan system failure and death in patients admitted to the Stanford University surgical intensive care unit. This method should permit health care organizations to evaluate a proposed trial's expected cost-benefit and the expected sample size that will resolve the question of interest, and thereby assist in the process of deciding whether to conduct the trial.

Adolescent↗
PubMed1998

A cost-benefit analysis of a cardiovascular disease prevention trial, using folate supplementation as an example.

OBJECTIVES: This study illustrates a cost-benefit analysis of clinical trial design, using as an example a trial of folate supplementation to prevent cardiovascular disease. METHODS: Bayesian statistical and decision-analytic techniques were used to estimate the cost-benefit and sample size of a placebo-controlled trial of folate targeted to US citizens, aged 35 to 84 years, with elevated serum homocysteine levels. The main end point is event-free survival (i.e., survival without new ischemic heart disease or stroke) at 5 years. RESULTS: Because the screening cost and annual cost and inconvenience of taking folate is small compared with the consequences of stroke, ischemic heart disease, or death, the increase in 5-year event-free survival with folate that should compel the use of folate is just 1.1%. The sample size per group needed to establish this level of folate's medical effectiveness is estimated to be 17310. Such a trial would provide an expected societal cost-benefit savings exceeding $11 billion within 15 years. CONCLUSIONS: This study illustrates how Bayesian methods may help in assessing the societal cost-benefit consequences of proposed disease prevention trials, deciding which trials are worth sponsoring, and designing cost-effective trials.

Adult↗
PubMed1997

When to base clinical policies on observational versus randomized trial data.

Physicians must decide when the evidence is sufficient to adopt a new clinical policy. Analysis of large clinical and administrative databases is becoming an important source of evidence for changing clinical policies. Because such analysis cannot control for the effects of all potential confounding variables, physicians risk drawing the wrong conclusion about the cause-and-effect relation between a change in clinical policy and outcomes. Randomized studies offer protection against drawing a conclusion that would lead to adoption of an inferior policy. However, a randomized study may be difficult to justify because of the extra costs of collecting data for a randomized study and concerns that a study will not directly benefit the patients enrolled in the study. This article reviews the advantages and disadvantages of basing clinical policy on analysis of large databases compared with conducting a randomized study. A technique is described and illustrated for accessing the potential costs and benefits of conducting such a study. This type of analysis formed the basis for a physician-managed health care organization deciding to sponsor a randomized study among patients with end-stage renal disease as part of a quality-improvement initiative.

Cardiovascular Diseases↗
PubMed1997

Effects of a self-administered previsit questionnaire to enhance awareness of patients' concerns in primary care.

OBJECTIVE: To determine if a self-administered previsit questionnaire designed to increase awareness of patients' concerns alters the visit duration, content of the discussion, and patient and physician satisfaction. DESIGN: A balanced, two-arm trial in which physicians were randomized. SETTING: Two primary-care clinics affiliated with a university hospital. PATIENTS/PARTICIPANTS: Ten physicians and 201 continuity-care patients. INTERVENTIONS: In intervention visits, patients completed a previsit questionnaire asking about the desire for medical information, psychosocial assistance, therapeutic listening, general health advice, and biomedical treatment. Physicians reviewed questionnaires with patients during the visit. MEASUREMENTS AND MAIN RESULTS: We used audiotapes of encounters to quantify the duration of the encounter and measured the number and type of diagnoses discussed in the visit, and patient and physician satisfaction with the encounter. Intervention visits were 34% longer (increase of 6.8 minutes; 95% confidence interval [CI] 0.4, 13.2) than control visits with most of the additional time spent in discussion of biomedical diagnoses (3.35 minutes; 95% CI 0.00, 6.72) and in the performance of the physical examination (2.7 minutes; 95% CI 0.5, 4.9). The number of diagnoses discussed per visit was 30% higher in intervention visits (increase of 1.7 diagnoses per visit; 95% CI 0.3, 3.2), but patients' satisfaction with these visits tended to be lower. CONCLUSIONS: Using a previsit questionnaire to increase awareness of the patients' concerns may entail a trade-off between conflicting goals: trying to respond to patient concerns while not significantly increasing the cost per visit. A future challenge is to develop and refine techniques with sufficient efficacy to justify the expense of implementing the intervention and the longer visit needed to respond adequately to patients' concerns.

Adult↗
PubMed1997

The economic impact of psychotherapy: a review.

OBJECTIVE: The authors reviewed data involving the impact of providing psychotherapy for psychiatric disorders on costs of care. METHOD: In a search of the MEDLINE database limited to peer-reviewed papers published from 1984 through 1994, 686 articles were identified. Forty-one articles, covering 35 studies, were found in which the intervention tested was psychotherapeutic and the study included measures of outcome that had some implications for cost. The exclusion criteria for reviewing these studies included absence of a comparison group, a focus on medical disorders instead of psychiatric illnesses, and outcomes that did not include cost data or measures from which costs could be inferred. On this basis, 18 of the 35 studies were selected for analysis. The studies were categorized according to whether or not subjects were randomly assigned to study groups. Two reviewers independently read each study to identify the following characteristics: inclusion criteria, exclusion criteria, types of interventions, main outcome variables, sample size, and statistical tests for significant differences between treatments. Outcomes had to include actual cost accounting or data on medical care utilization or work functioning. RESULTS: The findings of eight (80%) of the 10 clinical trials with random assignment and all eight (100%) of the studies without random assignment suggested that psychotherapy reduces total costs. CONCLUSIONS: Psychotherapy appears to have a beneficial impact on a variety of costs when used in the treatment of the most severe psychiatric disorders, including schizophrenia, bipolar affective disorder, and borderline personality disorder. Much of that impact accrues from reductions in inpatient treatment and decreases in work impairment.

Bipolar Disorder↗
PubMed1997

The effect of a patient's risk-taking attitude on the cost effectiveness of testing strategies in the evaluation of pulmonary lesions.

STUDY OBJECTIVES: To assess the health and cost effects of a patient's risk-taking attitudes about diagnostic tests. DESIGN: Cost-effectiveness analysis. SETTING: Diagnostic testing strategies used in the evaluation of a patient with a radiographically detected lung lesion were evaluated. Strategies included combinations of sputum, fine-needle aspiration, bronchoscopy, thoracoscopy, and expectant management. PATIENTS: Patient data were obtained from the Survival Epidemiology and End Results Program, MEDLINE search, National Center for Health Statistics, and the Universities of Iowa and Stanford, and Kaiser Permanente Hospital. INTERVENTIONS: Different patient risk-taking attitudes were simulated using decision analysis. MEASUREMENTS: Lifetime cost of medical care, life expectancy, and cost effectiveness. RESULTS: The cost effectiveness of competing strategies depended on patient attitudes about taking risks. For a patient averse to expectantly waiting without definitive knowledge of whether cancer was or was not present, testing strategies using invasive procedures, such as thoracoscopy, were more cost effective. In contrast, for a patient who was identical except that he or she was averse to tests with higher morbidity and mortality, strategies that involved expectantly waiting, instead of more invasive tests, were more cost effective. Small changes in some risk-taking attitudes resulted in large changes in cost effectiveness. CONCLUSIONS: Risk-taking attitudes influenced the cost effectiveness of testing strategies. Consideration of patient risk-taking attitudes in diagnostic testing appears warranted in setting clinical policies and making individual decisions.

Attitude to Health↗