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Biomedical subjects

Sean D Sullivan

Publications and source records attributed to Sean D Sullivan.

66 records · Page 4Linked to original sources
PubMedDate not supplied

A Bayesian approach to aid in formulary decision making: incorporating institution-specific cost-effectiveness data with clinical trial results.

Pharmacy and therapeutics committees commonly cite a lack of generalizability as a reason for not incorporating cost-effectiveness information into decision making. To address this concern, many committees undertake site-specific economic evaluations, which are often limited by small sample sizes and nonrandomized designs. We show how 2 complementary approaches were used to minimize these limitations in an economic evaluation of abciximab at 1 institution. Using a propensity score methodology, we selected patients who did not receive abciximab for the comparison cohort. Then, we adopted a Bayesian, hierarchical, random-effects model to integrate site-specific and clinical trial data. We applied the posterior distributions of effectiveness with local cost data in a traditional decision-analytic model. In 74% of the simulations, abciximab was cost-effective at 1 institution at the $50,000 per life year saved threshold, assuming a 50:50 split of patients undergoing coronary stenting and angioplasty. Among patients undergoing coronary stenting, the cost-effectiveness ratio of the addition of abciximab was at or below the $50,000 per life year saved threshold in 66.0% of the simulations.

Abciximab↗
PubMedDate not supplied

Comparison of directly elicited preferences to preferences derived from the SF-36 in adults with asthma.

INTRODUCTION: Algorithms have been developed that estimate preferences from the Short Form 36 (SF-36). The objective of this study was to compare SF-36-derived preferences to directly elicited preferences. METHODS: The authors used data from a clinical trial of adult asthmatics to derive preferences from the SF36 and compare those to visual analog scale (VAS) values and the Asthma Quality-of-Life Questionnaire (AQLQ). RESULTS: The differences between VAS and derived preferences ranged from -0.066 to 0.024 at baseline and 0.006 to 0.107 at the end of follow-up. All measures improved from baseline (P < 0.001); however, derived preferences underestimated change (0.066 to 0.131) compared to the VAS (0.173) (P < 0.001), which could affect economic evaluations. Correlations between preferences and the AQLQ ranged from 0.56 to 0.70 at baseline (P < 0.001) and 0.53 to 0.70 for changes from baseline (P < 0.001). CONCLUSIONS: The derivation methods produce valid and responsive measures of patient preference. However, derived preferences differ from one another and directly elicited VAS preferences.

Adrenal Cortex Hormones↗
PubMedDate not supplied

Community blood supply model: development of a new model to assess the safety, sufficiency, and cost of the blood supply.

BACKGROUND: Through a combination of predonation donor screening and donated unit testing, the blood supply is safer than ever. However, as a result of increasingly stringent screening measures, one of the greatest threats may be an insufficient supply. The balance between safety and adequacy of the blood supply has not received enough attention. STUDY DESIGN AND METHODS: The authors developed a model to allow for empirical investigation of the determinants of a safe and sufficient supply. The model is a cohort simulation of allogeneic whole-blood donation, with the population of presenting donors stratified into 8 age and gender groups because the probability of donor and donation deferral varies by these characteristics. Parameters are estimated from year 2000 Blood Centers of Pacific (BCP) data. The model includes cost parameters, which were estimated using BCP expenditure data. The main outcomes are the number of transfusable units of blood and the unit cost of procurement. RESULTS: The model tracks the production of a supply of blood, highlighting the influence of demographic characteristics, predonation deferral, underweight collection of blood units, and associated costs. The authors sought to establish model validity by showing that modeled results closely mimic the outcomes and costs observed by blood bank administrators. CONCLUSION: The model was developed to evaluate blood safety and policy decisions; it can be used to assess the impact of predonation deferrals, such as expanded European travel deferral for variant Creutzfeldt-Jakob disease, or the impact of new testing strategies, such as nucleic acid testing for West Nile virus.

Blood Donors↗
PubMedDate not supplied

Improving pediatric asthma outcomes in the community setting: does pharmaceutical care make a difference?

OBJECTIVE: To assess the effect of a structured program of pharmaceutical care on changes in disease control, functional status, and health services utilization for pediatric and adolescent patients with moderate-to-severe asthma. DESIGN: Randomized, controlled trial. SETTING: Community and clinic pharmacies (14 intervention and 18 usual care pharmacies) in western Washington State. PATIENTS: Three hundred thirty children, aged 6 to 17 years, with asthma. INTERVENTION: Structured training for the intervention group pharmacists to provide individualized asthma management services during patient-pharmacist encounters for up to 1 year following the patient's enrollment into the study. MAIN OUTCOME MEASURES: The primary outcome measure was change in pulmonary function as measured by peak expiratory flow rate and spirometry. Secondary outcome measures included changes in functional status and use of asthma-related health care services. RESULTS: The intervention had no significant effect on the health or health services use outcomes of study subjects. When compared with the usual care group, there was no evidence that patients from the intervention group experienced improvements in pulmonary function, functional status, quality of life, asthma management, or satisfaction with care. In addition, there were no differences between groups in use of anti-inflammatory medications, total or asthma-related medical care utilization, or total or asthma-related school days lost. CONCLUSION: This pharmaceutical care intervention had no significant effect on the health or health services use outcomes of pediatric patients with asthma. The intervention may not have been powerful enough to significantly affect pharmacists' behaviors and asthma patients' outcomes in community pharmacy settings, and there is evidence that the pharmacists' compliance with the study protocol was low due, in part, to patient- and practice-related obstacles.

Adolescent↗
PubMedDate not supplied

Clinical use of medical devices in the 'Bermuda Triangle'.

The pace of medical technological development shows no sign of abating. Analyzing the effect of major federal health agencies on the availability of such technology is critical. This paper describes functions of three government health agencies: the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). Certain medical technologies fall into gaps between these agencies, which pose challenges in today's era of demand for evidence-based medicine. We suggest new policy and pragmatic strategies that can close the gaps and move decision making relevant to technology forward more rapidly than is now the case.

Biomedical Technology↗
PubMedDate not supplied

Evidence, economics, and emphysema: Medicare's long journey with lung volume reduction surgery.

Use of lung volume reduction surgery (LVRS) increased in the mid-1990s as a palliative therapy for severe emphysema. Rapid growth in procedure volume despite little evidence supporting its safety and effectiveness prompted the Centers for Medicare and Medicaid Services (CMS) to suspend payments and cosponsor a nationwide randomized controlled trial to evaluate the procedure. In this paper we describe the trial and its influence on the CMS's recent coverage decision for LVRS. We describe the implications of this study for evidence-based evaluation of surgical procedures and Medicare's potential role in evaluating experimental treatments that affect its beneficiaries.

Centers for Medicare and Medicaid Services, U.S.↗
PubMedDate not supplied

States' control of prescription drug spending: a heterogeneous approach.

In an effort to balance Medicaid budgets, states use prescription drug cost containment tools in unique ways and in varying combinations. We report on the variability in state-level strategies to control the cost of prescription drugs and describe broad state-to-state differences in per beneficiary spending on drugs. This heterogeneity raises the question of appropriate state program variability. Research is needed to determine the medically, ethically, and legally most suitable means of controlling drug costs, especially as the Medicare Part D drug plan will likely recapitulate the prescription drug program variability observed among the states.

Aged↗
PubMedDate not supplied

Managing biotechnology in a network-model health plan: a U.S. private payer perspective.

Emerging biotechnology poses challenges to payers, including access, coverage, reimbursement, patient selection, and affordability. Premera Blue Cross, a private regional health plan, developed an integrated cross-functional approach to managing biologics, built around a robust formulary process that is fast, flexible, fair, and transparent to stakeholders. Results are monitored by cost and use reporting from merged pharmacy and medical claims. Utilization management and case management strategies will integrate with specialty pharmacy programs to improve outcomes and cost-effectiveness. Creative approaches to provider reimbursement can align providers' incentives with those of the plan. Redesign of member benefits can also encourage appropriate use of biotechnology.

Biological Products↗
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Examining the value and quality of health economic analyses: implications of utilizing the QHES.

OBJECTIVE: To examine the increasing use of health economic studies and practical implications of evaluating their quality utilizing the Quality of Health Economic Studies (QHES) instrument. METHODS: We first reviewed secondary references to examine ways in which health economic analyses are used in different health care settings, the manner in which these data are appraised and evaluated, and their relevance and value in decision making. The QHES, a new instrument designed to support fast, accurate initial assessments of study quality, was then introduced and validated. A case study was performed using the QHES to score the quality of 30 cost-effectiveness studies in gastroesophageal reflux disease (GERD) published since 1985. Areas where additional research could guide efforts to identify and enhance the use of higher-quality cost-effectiveness studies were suggested. RESULTS: Results from the published validation study of the QHES demonstrated the validity of this new instrument. The resulting QHES scores in the case study of GERD papers ranged from 43 to 91 with a mean of 63.6 (SD=14.7). Approximately 27% of the studies rated had scores less than 50, and 27% had scores above or equal to 75. All 30 studies made conclusions and recommendations and justified them based on their study results. Most studies used appropriate cost and health outcome measures. Very few studies stated the perspective of their analysis and reasons for its selection. The majority of the studies did not perform incremental analysis. CONCLUSION: An examination of the QHES validation study and the case study in GERD suggests that there is a rationale and potential utility to use a quality scoring system for cost-effectiveness studies. The QHES may play an important role in discriminating higher-quality cost-effectiveness information to enhance decision making. The QHES can also serve as a guideline for conducting and reporting future cost-effectiveness studies, as an aid in the editorial process, and for stratification in systematic reviews. Complex decisions regarding resource allocation rarely rely solely on economic considerations but do increasingly use health economic analyses. To the extent that such analyses are used, the QHES may help ensure that higher-quality analyses receive more analytic attention and greater weight in the decision-making process.

Cost-Benefit Analysis↗
PubMedDate not supplied

Emerging therapeutic strategies for asthma management.

OBJECTIVE: The describe the mechanisms of action of and clinical experience to date with novel asthma drug therapies. DATA SOURCES: This article is based, in part, on a presentation given by Eli O. Meltzer, MD, at a symposium entitled. New Frontiers in Asthma Management: Biotechnology for Optimal Therapeutic and Economic Outcomes. at the Academy of Managed Care Pharmacy's 15th Annual Meeting and Showcase in Minneapolis, Minnesota, on April 10, 2003. CONCLUSIONS: Various elements of the pathophysiologic processes involved in allergic asthma, including type 2 helper T lymphocytes, cytokines, and immunoglobulin E (IgE), have been the targets of new drug research. Clinical experience with omalizumab, a humanized anti-IgE monoclonal antibody, is promising.

Adjuvants, Immunologic↗
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Asthma in the United States: recent trends and current status.

OBJECTIVE: To describe the prevalence of and morbidity and mortality from asthma in Americans and the impact of the disease on health resource utilization and costs, define asthma control and characterize the extent to which it is achieved with recommended asthma therapies, discuss patterns of medication use in patients with asthma who are at high risk for morbidity and mortality, characterize health resource utilization and morbidity in patients with difficult-to-treat asthma, and identify the objectives of asthma drug therapy research efforts. DATA SOURCES: This article is based on a presentation given by the author at a symposium entitled. New Frontiers in Asthma Management: Biotechnology for Optimal Therapeutic and Economic Outcomes. at the Academy of Managed Care Pharmacy's 15th Annual Meeting and Showcase in Minneapolis, Minnesota, on April 10, 2003. CONCLUSIONS: The prevalence of asthma and associated costs has increased in the United States. Patients with asthma that is difficult to treat because of frequent or severe exacerbations, inability to avoid asthma triggers, or the need for multiple drug therapies or complex medication regimens are responsible for a disproportionately large share of health resource utilization and costs. Medication use is less than optimal in many patients with asthma who are at high risk for morbidity and mortality, and asthma control is poor in many patients despite the use of recommended drug therapies. Results of the TENOR Study, a large, 3-year, multicenter, observational cohort study, demonstrated that difficult-to-treat asthma is associated with substantial health resource utilization and morbidity. New asthma drug therapies are needed to improve asthma control, patient adherence to the therapeutic regimen, and quality of life and reduce the incidence of asthma exacerbations, health resource utilization, and costs.

Anti-Asthmatic Agents↗