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Biomedical subjects

J Mauskopf

Publications and source records attributed to J Mauskopf.

16 recordsLinked to original sources

Health policy issues and applications for evidence-based medicine and clinical practice guidelines.

Evidence-based medicine and clinical practice guidelines have become increasingly salient to the international health care community in the 1990s. Key issues in health policy in this period can be categorised as costs and access to care, quality of and satisfaction with care, accountability for value in health care, and public health and education. This paper presents a brief overview of evidence-based medicine and clinical practice guidelines and describes how they are likely to influence health policy. Evidence-based medicine focuses on the use of the best available clinical (efficacy) evidence to inform decisions about patient care; guidelines are statements systematically developed from efficacy and effectiveness research and clinical consensus for practitioners and patients to use in making decisions about appropriate care under different clinical circumstances. Both fields have developed methods for evaluating and synthesising available evidence about the outcomes of alternative health care interventions. They have clear implications for health policy analysts: greater reliance should be placed on scientific evidence, policy decisions should be derived systematically, and health care decisionmaking must allow for the active participation of health care providers, policy makers, and patients or their advocates. The methods and information generated from evidence-based guidelines efforts are critical inputs into health policy analysis and decision-making.

Decision Making

The cost-effectiveness of treatment with lamivudine and zidovudine compared with zidovudine alone: a comparison of Markov model and trial data estimates.

In this paper, we present a Markov model for estimating the cost-effectiveness of combination therapy with lamivudine (LMV) and zidovudine (ZDV) compared with ZDV alone. We also compare the predictions of the Markov model for the impact of combination therapy on trial period costs with the actual impact of combination therapy on selected trial period costs estimated from data collected during the clinical trials. In the Markov model, disease stages were defined by CD4 cell count. Based on clinical trial data for patients with CD4 counts higher than 100 cells/mm3, the model assumed that the CD4 cell count level could be maintained above the level at the initiation of therapy for 6.5 months with monotherapy and for 18 months with combination therapy. After this period, transition rates for natural disease progression were used. Incremental lifetime costs and quality-adjusted life years gained with LMV/ZDV compared with ZDV alone were estimated for cohorts of patients initiating antiretroviral therapy at four different CD4 cell count stages. Cost per life year gained varied from $10,000 to $18,000, and cost per quality-adjusted life year gained varied from $14,000 to $27,000. In both cases, the combination therapy was more cost-effective when started earlier in disease progression. These estimates were not sensitive to changes in key parameter values. In addition, the model was used to estimate the impact of combination therapy on healthcare costs during the trial period; these estimated costs were compared with data on the cost of resource use collected during the clinical trial for hospital stays, unscheduled visits, medications, and outpatient procedures. Both the Markov model estimates and the trial data estimates for the trial period showed cost savings in other medical costs, though these were not large enough to completely offset the increased cost for antiretroviral therapy. The model estimates were more conservative than the estimates based on the trial data.

Cost-Benefit Analysis

Results of the economic evaluation of the first study. A multinational prospective economic evaluation. FIRST Investigators. Flolan International Randomized Survival Trial.

We present the prospective economic evaluation that served as a secondary endpoint for the FIRST study, a randomized international multicenter trial of patients with severe congestive heart failure. Although the clinical results of this study were disappointing, we demonstrated the feasibility of incorporating prospective economic evaluation in phase III clinical trials.

Aged

A strategy for collecting pharmacoeconomic data during phase II/III clinical trials.

This article presents an overview of the process and organisational aspects required to support the collection of pharmacoeconomic (PE) data during phase II and phase III clinical trials of pharmaceutical products. The process described requires early involvement of the PE study team in clinical trials design and planning, as well as continuing close collaboration between the PE study team and the clinical study team as the data collection plans are implemented. Adequate resources must be made available for staffing and funding the PE component of data collection and analysis. If the suggested procedures are adequately resourced and implemented, the result should be a comprehensive, complete and accurate database that will allow the PE study team to characterise the economic value of the new drug at the same time as the clinical study team characterise its safety and efficacy. Integrated clinical and economic evaluations are essential for the appropriate use of pharmaceutical products in rapidly changing markets.

Clinical Trials, Phase II as Topic

Full-cost determination of different levels of care in the intensive care unit. An activity-based costing approach.

We applied an activity-based costing methodology to determine the full cost of intensive care service at a community hospital, a university hospital and a health maintenance organisation (HMO)-affiliated hospital. A total of 5 patient care units were analysed: the intensive care unit (ICU) and surgical ICU (SICU) at the university setting, the ICU at the community setting, and the SICU and cardiac care unit at the HMO setting. The selection of the different ICU types was based on the types of critical care units that were found in each setting (e.g. the HMO did not have an ICU). Institution-specific cost data and clinical management parameters were collected through surveys and site visits from the 3 respective organisation types. The analysis revealed a marked increase in patient-minute cost associated with mechanical ventilation. Higher costs associated with prolonged neuromuscular blockade have important economic implications with respect to selection of an appropriate neuromuscular blocking agent.

Coronary Care Units

Methodological and conduct principles for pharmacoeconomic research. Pharmaceutical Research and Manufacturers of America.

In January 1995, the Pharmaceutical Research and Manufacturers of America (PhRMA) adopted a voluntary set of principles to provide guidance for its member companies on the conduct and evaluation of pharmacoeconomic research. The principles were prepared by a working group of pharmacoeconomic scientists from the PhRMA Task Force on the Economic Evaluation of Pharmaceuticals. The principles were reviewed by a panel of academic experts and outside reviewers at each stage of their development. The PhRMA document consists of a set of broad principles that will foster high quality pharmacoeconomic research without impeding further methodological development of the field. Specific recommendations are offered in those methodological areas for which general agreement exists. However, no attempt was made to force a consensus for those methodological issues which have yet to be resolved. The principles address methodology and reporting of research rather than sponsor-investigator relationships or conflict of interest issues, which have been addressed elsewhere. This approach is based on the belief that the scientific integrity of pharmacoeconomic research is best ensured through the soundness of the research methods used and the full disclosure and transparency of all methods, analyses and results.

Communication

The Nottingham Health Profile as a measure of quality of life in zoster patients: convergent and discriminant validity.

The main symptoms of zoster, a disease caused by the reactivation of the varicella zoster virus (that causes chicken-pox) are: rash, associated with pain, burning, or itching, and pain that outlasts the rash sometimes by months or years. The uncomfortable and long-lasting symptoms of herpes zoster are likely to compromise the patient's quality of life. However, the impact of zoster on health-related quality of life has not previously been measured directly. Recent papers have demonstrated the ability of generic measures to discriminate among patients with different clinical symptoms. In this paper, we demonstrate the convergent validity for zoster of a generic measure, the Nottingham Health Profile (NHP), by measuring its correlation with rash progression, pain levels, and pain medications. The discriminant validity of the NHP was demonstrated by its ability to distinguish between different levels of pain severity. The NHP dimensions most highly correlated with the pain measures, were pain (0.42-0.50), energy (0.34-0.38) and sleep (0.32-0.38). The NHP scores in all six dimensions show large differences at different levels of pain severity that are statistically significant. These results demonstrate the NHP's validity as a measure of health-related quality of life in zoster patients.

Health Status Indicators

Patterns of Medicaid expenditures after AIDS diagnosis.

This article examines average monthly Medicaid expenditures after diagnosis of acquired immunodeficiency syndrome (AIDS) for the diagnosis, mid-illness, and death intervals, as well as Kaplan-Meier estimates of expenditures from AIDS diagnosis to death. A clinical severity measure (the Severity Index for Adults with AIDS [SIAA]) designed to be predictive of patient survival was applied to a population of continuously enrolled New York State Medicaid patients who survived at least 6 months after being diagnosed with AIDS. Our findings suggest that groups of more seriously ill patients who appear to have more intense demand for health care services, especially over the diagnosis and mid-illness intervals, can be identified using the SIAA.

Acquired Immunodeficiency Syndrome

Patterns of ambulatory care for AIDS patients, and association with emergency room use.

OBJECTIVE: We examined the association of patterns of ambulatory care for AIDS patients with any use of the emergency room (ER) and the monthly rate of ER visits in the six months after AIDS diagnosis. DATA SOURCES/STUDY SETTING: The study population was obtained from the New York State Medicaid HIV/AIDS Research Data Base and includes patients diagnosed with AIDS from 1983 to 1990. DATA COLLECTION/EXTRACTION METHODS: To examine patterns of care and ER use not leading to hospitalization, we studied patients who survived at least six months after their first AIDS-defining diagnosis. The data base included person level information on visits to different provider sites and patient demographic and clinical characteristics. STUDY DESIGN: We defined the dominant provider as the site delivering the majority of ambulatory care for patients with a minimum of four ambulatory visits in the six months after AIDS diagnosis. Dominant providers were classified by specialty and setting: generalist physician; general medicine clinic; AIDS specialty clinic; and other specialty clinic or physician (e.g., cardiology). Patients without a dominant provider were grouped into those with four or more visits and those with fewer than four visits. Regression analysis was used to estimate relationships between ER use and patterns of ambulatory care and patient demographic and severity of illness characteristics. PRINCIPAL RESULTS: The study population included 9,155 AIDS patients aged 13 to 60 years at diagnosis, continuously Medicaid-enrolled, and surviving at least six months after AIDS diagnosis. Among those with four or more visits (56 percent), over 70 percent had a dominant provider. Overall, 39 percent of the study population visited the ER while, in the group with four or more visits, 53 percent of those without a dominant provider had an ER visit. Patients without a dominant provider were estimated to have 32 percent higher odds of ER use than patients with a dominant provider. Among patients with a dominant provider, patients with a generalist or primary care clinic dominant site of care were estimated respectively to have 18 percent and 23 percent lower odds than patients with an AIDS specialty clinic as the dominant site of care. Drug users had higher odds of ER use, as did women. CONCLUSIONS: In this Medicaid AIDS population, a dominant provider delivering the majority of a patient's care was associated with less use of the ER by the patient. Among patients with a dominant provider, ER use was lowest for those with a primary care provider. Further examination of the type and availability of ambulatory services in AIDS specialty clinics and primary care settings, as well as more detailed information on patient characteristics, may reveal reasons for these patterns of ER use.

Acquired Immunodeficiency Syndrome

The performance of urban and public hospitals and NHCs (neighborhood health centers) under Medicaid capitation programs.

This article reports the results of a study that examined what happened to the utilization of Medicaid beneficiaries, eligible under Aid to Families with Dependent Children, who were mandatorily enrolled in several capitated alternatives in the Kansas City area. Their experience is contrasted with that of a comparison group selected from the St. Louis area. The types of plans analyzed include those sponsored by hospitals, neighborhood health centers, HMOs, and private physicians (IPAs). With the exception of emergency room use, all plans controlled utilization equally well. Results are explained in light of their management and policy implications.

Adult

Medicaid program characteristics: effects on health care expenditures and utilization.

Relationships between State Medicaid program characteristics and program outputs are analyzed in this statistical report, using 1980 cross-sectional data from a variety of sources. The year 1980 furnishes a baseline against which program changes following the Omnibus Budget Reconciliation Act of 1981 and the 1982 economic recession can be evaluated. Utilization and expenditures are modeled separately for each aid category and each major service category. This use of multiple models allows for measurement of the effect of program controls that might not appear in models of total utilization and expenditures.

Adult

Fertility and replacement: some alternative stochastic models and results for Brazil.

The observed joint distribution of births and child deaths for a cohort of women at a given point in time depends on the number of children that would have been born had the family experienced no deaths, the number of child deaths experienced, and the proportion of these deaths that are replaced by a subsequent birth. In this paper we estimate the parameters of the assumed distributions of these three events using a minimum distance estimation model and data from the 1970 Brazilian census. The parameter estimates are shown to be similar to those obtained previously using a maximum likelihood estimation model. When the data are subdivided according to women's years of schooling, estimates of probability of a child death and mean and variance of children born if no deaths decrease while estimates of probability of replacement of a dead child increase as years of schooling increase.

Adult

Interaction of uncharged bile salt derivatives with the ileal bile salt transport system.

Two series of uncharged conjugated bile salt derivatives, N-conjugates of ethanolamine and 3-amino-1,2-propanediol were studied for interaction with the ileal bile salt transport system. Evidence for interaction is threefold. 1) In everted gut sac experiments more material was removed from the mucosal compartment when ileal sacs were used. 2) These derivatives inhibited the in vitro transport of taurocholate. 3) In vivo intestinal perfusion demonstrated greater absorption from ileum than from jejunum. Number three demonstrates that such interactions are followed by transmucosal movement. Their uphill transport was less than taurocholate transport. The Na(+) requirement for cholyl-3-amino-1,2-propanediol interaction with the system was greater than for taurocholate. This observation is similar to that previously observed with taurodehydrocholate, which had a greater Na(+) requirement for transport than taurocholate. Therefore removal of the anionic charge, as well as distortion of steroid shape, increases the Na(+) requirement for substrate interaction with the transport system. These observations support our hypothesis that this interaction involves two recognition components; one includes the steroid moiety, the other a coulombic interaction between the anionic bile salt and a cationic membrane site. Additionally the membrane would have an anionic group to accomodate the Na(+). Both factors (steroidal and coulombic) operate for optimal substrate attachment. Simultaneously the system's affinity for Na(+) increases and active transport then proceeds.

Animals

Ionic requirements for the active ileal bile salt transport system.

Taurocholate transport by everted ileal gut sacs was studied in physiological media containing graded amounts of sodium ions. Significant uphill transport of taurocholate was observed when the bulk of NaCl was replaced by osmotic equivalents of mannitol or choline chloride. Seventy-seven percent of control transport activity was observed when 36 milliequivalents per liter of Na+ were present in the incubation medium with mannitol acting as the isosmotic replacement, and 74% of the control transport was retained when 31 milliequivalents per liter of Na+ were present in the incubation medium with choline chloride acting as the osmotic replacement. Lowering the Na+ concentration to 19 milliequivalents per liter (i.e., 84% replacement of Na+) still allowed for 69% of the uphill transport observed in the control incubations. Taurodehydrocholate transport by ileal everted sacs was more sensitive to decreased Na+ concentrations; 29% of control transport was observed at 31 milliequivalents per liter of Na+. A kinetic analysis comparing the transport of taurocholate with taurodehydrocholate, the triketo analogue, at different concentrations of Na+ indicated that the apparent affinity of the transport system for Na+ is greater in the presence of taurocholate than in the presence of taurodehydrocholate. The ability of taurodehydrocholate to depress taurocholate transport is less in media of low Na+ concentration. Finally, in vivo intestinal perfusion studies demonstrated that the depression of taurocholate absorption, following Na+ removal, is reversible. These results are in agreement with the idea that Na+ has a physiological role in intestinal bile salt transport, and that the affinities of the anionic bile salt and the sodium cation for the transport system appear to be cooperative in that one enhances the binding of the other.

Animals