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PubMed2005

Are incentive-based formularies inversely associated with drug utilization in managed care?

OBJECTIVE: To review recent studies comprehensively assessing the impact of incentive-based multitier formularies on pharmaceutical costs and utilization. DATA SOURCES: PubMed (2001-December 2003) was searched using the key terms formularies, cost-sharing, and drug costs. STUDY SELECTION AND DATA EXTRACTION: Studies addressing the impact of implementing multitiered incentive-based formularies as a central component of an outpatient drug benefit were selected. DATA SYNTHESIS: One study using pharmacy claims from 25 employers with data from 402 786 members modeled the range of anticipated plan/employer savings associated with single- to 3-tier shifts and found that, going from a single- to 3-tier benefit results in decreased plan/employer pharmaceutical costs from $650 to $494 (24% decrease) per member per year and decreased pharmaceutical utilization from 12.3 to 9.4 (23.6% decrease) prescriptions per member per year. Another study demonstrated that adding an additional tier decreased pharmaceutical utilization, with a dramatic increase in member contribution offsetting the plan's expected increase in expenditures. This shift in pharmaceutical expenditures appeared to have no effect on overall medical utilization over a 3-year follow-up. Finally, a study converting members from a single- to 3-tier incentive-based formulary, associated with two- to fourfold copayment increases, resulted in a 10% discontinuation rate for angiotensin-converting enzyme inhibitors, statins, and proton-pump inhibitors among members who were primarily hourly employees. For salaried workers, the addition of a tier to their benefit appeared to have minimal impact on pharmaceutical utilization. CONCLUSIONS: Emerging data suggest a potential inverse relationship between pharmaceutical utilization and incentive-based formularies that increase member contribution to drug costs. Future research should focus on identifying price points and percentage increases at which members are likely to begin discontinuing necessary medications.

Fees, Pharmaceutical↗
PubMed1999

Identification of a novel Skp2-like mammalian protein containing F-box and leucine-rich repeats.

The F-box protein Skp2 is important for S phase entry and binds to Skp1 and the cyclin A-Cdk2 complex. Here we report the cloning, analysis of genomic organization and characterization of a novel gene product related to Skp2 named FBL2. The human FBL2 gene was found to be a highly interrupted gene of at least 126.6 kb located on chromosome 17 in close proximity to the TRAP220 gene in a head-to-tail orientation. The predicted protein contains an F-box and six perfect C-terminal leucine-rich repeats. Similar to Skp2, this protein interacts with Skp1 and deletion of the F-box inhibits this association. However, in contrast to Skp2, FBL2 was detected in non-proliferating hepatocytes and its expression increased in growth-arrested liver epithelial cells. In addition, FBL2 was localized primarily in the cytoplasm concentrated around the nucleus. Overall, our data indicate that although FBL2 shares strong structural homology with Skp2 as well as having a similar ability to associate with Skp1, these proteins likely play distinct roles and target different substrates to the SCF complex.

Amino Acid Sequence↗
PubMed1976

Antigenicity of the M proteins of group A hemolytic streptococci: further evidence for shared determinants among serotypes.

Shared antigenic determinants between M proteins of group A streptococci appear to be widespread among serotypes. This is demonstrated by the ability of purified M proteins to absorb opsonic antibody from a variety of heterologous antisera prepared against whole cells or purified M proteins. This absorption procedure has the capacity to separate passive mouse protecting and passive hemagglutinating antibodies from opsonic antibodies measured in vitro. When whole cells or M proteins are used as heterologous absorbents, immunoglobulin may be recovered from the cells or precipitates. The recovered antibody has most of the opsonic and some of the precipitating qualities of the original unabsorbed serum, but hemagglutinating titers are significantly lower. These data provide additional evidence that shared antigenicity among M proteins can be the result of common antigenic determinants. Arguments are presented that these cross-reactions are not the result of a nonspecific protein fraction associated with purified M proteins.

Animals↗
PubMed1994

Telemedicine on the move: health care heads down the information superhighway.

Telemedicine has drawn increasing attention as one of the emerging new service delivery vehicles that will run on the information superhighway. In reality, remote diagnosis and consultation through the application of telecommunications technology have been practiced for many years. But advances in technology and reform imperatives to extend access beyond traditional boundaries are pushing telemedicine into new applications. This is evidenced by the explosion in the number of pilot projects begun within the last 12 months. While demonstrating telemedicine's growing capabilities--for education and administration, as well as medical practice--these projects also raise a number of legal, clinical, and technical questions that must be answered before government and other payers will routinely reimburse for remote services. Academic and industry consortia are springing up to deal with the most compelling issues, including documenting telemedicine's safety and efficacy, developing uniform data and transmission standards, and determining the minimum resolution needed to maintain the integrity of clinical transmissions. Almost every type of medical specialty has proved amenable to performing evaluations via telemedicine links; however, specialties with less direct patient contact, like radiology and pathology, are generally identified as better candidates for telemedicine interactions. The telemedicine equipment required for these consults ranges from the simple to the ultra-sophisticated, depending on the type of system used and its clinical application. The most common system configuration involves a base station in the main facility where specialists and other consultants are housed and a number of remote referral sites. Consults are performed by interactively sharing voice, video, or image data. Increasingly, systems are being introduced that use easy-to-learn, intuitive displays and controls. Systems also require the use of any number of different communication media including land-based wire networks, high-speed fiberoptics, microwave links, or satellite transponders. Quantum leaps in telemedicine performance are being made constantly, many being swept along as a result of intensified interest in developing similar consumer and business services that are destined for the new information highway. In addition to information infrastructure projects, telemedicine has also recently benefitted from the effects of defense reinvestment, political interest in cost-reducing technologies, increased availability of funding for pilot projects, and the emergence of multifacility, multitiered, integrated delivery systems. Technical, financial, and logistical factors, which had once worked against telemedicine feasibility, are suddenly shifting to rapidly propel telemedicine technologies out of investigational settings and into mainstream clinical practice.

Computer Communication Networks↗
PubMed2004

Conditional multipoint linkage analysis using affected sib pairs: an alternative approach.

Recently, Liang et al. ([2001b] Genet. Epidemiol. 21:105-122) proposed a conditional approach to assess linkage evidence on the target region by incorporating linkage information from an unlinked (reference) region using allele shared IBD (identity-by-decent) from affected sib pairs. This is carried out by conditioning on the IBD sharing value at the estimated trait locus of the reference region. Since markers considered are typically non-fully informative, the IBD sharing at each marker needs to be estimated (or imputed). In this report, we propose an alternative approach to deal with the IBD sharing in the reference region. This new approach makes full use of the observed data without having to categorize the imputed IBD sharing as needed in Liang et al. ([2001b] Genet. Epidemiol. 21:105-122). We compare these two approaches by simulating data from a variety of two-locus models including heterogeneity, additive and multiplicative with either fully informative markers or non-fully informative markers. The performance of both approaches is quite comparable showing consistent estimates of the trait locus and key genetic parameters.

Alleles↗
PubMed1999

Comment on the use of GOES solar proton data and spectra in solar proton dose calculations.

There is a need to understand the calibration and response of the GOES solar particle detectors since the GOES data are being used to evaluate high energy solar particle events. We share some of our experience in utilizing these data in the analysis of solar particle ground-level events (GLEs). For the 29 September 1989 event, we have evaluated the solar proton and alpha particle spectral characteristics throughout the event. The results show that the solar cosmic ray spectrum is extremely hard at low energies with the magnitude of the slope increasing with increasing energy and with time.

Alpha Particles↗
PubMed1986

Isomeric fatty acids in the US diet: levels and health perspectives.

Data on market size, market share, and compositional changes of various products made from partially hydrogenated fats and oils were used to estimate current, previous, and predicted levels of trans fatty acids in the US diet. Recent literature and various perceptions of the toxicological, physiological, and nutritional effects of trans fatty acids were reviewed. Trans acid availability has changed little during the last 15-20 yr and currently is estimated to be approximately 7.6 g X person-1 X day-1. Modest decreases in total fat intake, including trans fatty acid intake, may occur in the future if consumers adopt certain dietary recommendations. We believe that concerns about possible relationships of trans fatty acids to development of atherosclerotic disease or cancer are not supported by reliable data. Numerous literature accounts support the conclusion that trans fatty acids do not pose any harm to humans or animals consuming a balanced diet containing adequate linoleic acid.

Animals↗
PubMed2005

Adult retinal pigment epithelium cells express neural progenitor properties and the neuronal precursor protein doublecortin.

The adult mammalian retina is devoid of any detectable neurogenesis. However, different cell types have been suggested to potentially act as neural progenitors in the adult mammalian retina in vitro, such as ciliary body (CB), Muller glia, and retinal pigment epithelium (RPE) cells. In rodents and humans, strong evidence for neural stem or progenitor properties exists only for CB-derived cells, but not for other retinal cell types. Here, we provide a comparative analysis of adult rat CB- and RPE-derived cells suggesting that the two cell types share certain neural progenitor properties in vitro. CB and RPE cells expressed neural progenitor markers such as Nestin, Flk-1, Hes1, and Musashi. They proliferated under adherent and neurosphere conditions and showed limited self-renewal. Moreover, they differentiated into neuronal and glial cells based on the expression of differentiation markers such as the young neuronal marker beta-III tubulin and the glial and progenitor markers GFAP and NG2. Expression of beta-III tubulin was found in cells with neuronal and non-neuronal morphology. A subpopulation of RPE- and CB-derived progenitor cells expressed the neurogenesis-specific protein doublecortin (DCX). Interestingly, DCX expression defined a beta-III tubulin-positive CB and RPE fraction with a distinct neuronal morphology. In summary, the data suggest that RPE cells share with CB cells the potential to de-differentiate into a cell type with neural progenitor-like identity. In addition, DCX expression might define the neuronal-differentiating RPE- and CB-derived progenitor population.

Animals↗
PubMed2005

Epstein-Barr virus LMP1 inhibits the expression of SAP gene and upregulates Th1 cytokines in the pathogenesis of hemophagocytic syndrome.

The primary infection of Epstein-Barr virus (EBV) may result in fatal infectious mononucleosis or hemophagocytic syndrome (HPS) in 2 diseases; that is, X-linked lymphoproliferative disorder (XLP) and hemophagocytic lymphohistiocytosis (HLH). XLP is linked to mutations of the SAP/SH2D1A gene with dysregulated T-cell activation in response to EBV infection. Patients with sporadic HLH, however, usually have no mutation of the SAP/SH2D1A gene, and EBV latent membrane protein-1 (LMP1) can up-regulate Th1 cytokines in EBV-infected T cells. Since both diseases share common manifestations of HPS, it is important to clarify whether a cross-talk exists between signaling lymphocyte activation molecule (SLAM)-associated protein (SAP) and LMP1-mediated pathways to explain the common pathogenesis of HPS. In this study, no mutation of the SAP/SH2D1A gene at exon 2/3 was detected in 7 HLH cases. Interestingly, EBV LMP1 could transcriptionally inhibit the expression of SAP/SH2D1A and activate downstream molecules ERK and interferon-gamma (IFN-gamma). LMP1-mediated SAP/ERK/IFN-gamma signals appear to act via the TNF receptor-associated factor (TRAF)2,5/nuclear factor kappaB (NF-kappaB) pathway, since dominant-negative TRAF2/5 and NF-kappaB inhibitor could rescue SAP expression and downregulate IFN-gamma. Although HLH is genetically distinct from XLP, our data suggest that both diseases share a common signal pathway, through either the mutation or LMP1-mediated suppression of the SAP gene, leading to overt T-cell activation and enhanced Th1 cytokine secretion in response to EBV infection.

Adolescent↗
PubMed2002

The putative capsid protein of the newly identified avian hepatitis E virus shares antigenic epitopes with that of swine and human hepatitis E viruses and chicken big liver and spleen disease virus.

We recently identified a novel virus, designated avian hepatitis E virus (avian HEV), from chickens with hepatitis-splenomegaly (HS) syndrome in the USA. We showed that avian HEV is genetically related to swine and human HEVs. Here we report the antigenic cross-reactivity of the putative open reading frame 2 (ORF2) capsid protein of avian HEV with those of swine and human HEVs and the Australian chicken big liver and spleen disease virus (BLSV). The region encoding the C-terminal 268 amino acid residues of avian HEV ORF2 was cloned into expression vector pRSET-C. The truncated ORF2 protein was expressed in E. coli as a fusion protein and purified by affinity chromatography. Western blot analysis revealed that the avian HEV ORF2 protein reacted with antisera against the Sar-55 strain of human HEV and with convalescent antisera against swine HEV and the US2 strain of human HEV, as well as with antiserum against BLSV. Convalescent sera from specific-pathogen-free chickens experimentally infected with avian HEV also reacted with the recombinant capsid proteins of swine HEV and Sar-55 human HEV. Antisera against the US2 human HEV also reacted with recombinant ORF2 proteins of both swine HEV and Sar-55 human HEV. The antigenic cross-reactivity of the avian HEV putative capsid protein with those of swine and human HEVs was further confirmed, for the most part, by ELISA assays. The data indicate that avian HEV shares certain antigenic epitopes in its putative capsid protein with swine and human HEVs, as well as with BLSV. The results have implications for HEV diagnosis and taxonomy.

Amino Acid Sequence↗
PubMedDate not supplied

Characteristics of drug abusers that discriminate needle-sharers.

To identify variables that discriminate needle-sharing among drug abusers, 224 male drug abusers were studied. They had been admitted to a 30-day inpatient drug treatment program over a 19-month period (September 1983 through March 1985). The variables examined were divided into three categories: demographic (age, race, education), personality (Minnesota Multiphasic Personality Inventory [MMPI] scores and MMPI deviant scores), and drug use patterns (drug of choice, use of single or multiple [mixed] drugs, severity of drug use, and place of use). Three variables were identified that discriminated needle-sharers from other drug abusers. Compared with other drug abusers, needle-sharers used more multiple drugs, were more likely to use a "shooting gallery," and had more problems related to drug use. No demographic or personality variables discriminated needle-sharers from nonsharers. The data suggested that needle-sharing is widespread in the drug culture. Needle-sharing was not confined to a particular racial group, educational level, or personality type. These findings can be used to structure education programs about acquired immunodeficiency syndrome (AIDS) for drug abusers. Drug treatment programs appear to provide an important opportunity to educate drug abusers about AIDS and related health issues associated with needle-sharing.

Adult↗
PubMed1998

Murine cerberus homologue mCer-1: a candidate anterior patterning molecule.

Xenopus cerberus (Xcer) is a cytokine expressed in anterior mesendoderm overlapping and surrounding Spemann's gastrula organiser. When misexpressed in blastomeres, Xcer can induce ectopic heads with well-defined brain, cement gland, olfactory placodes, cyclopic eye, and occasionally liver and heart. We report here the identification of mCer-1, a murine gene related to cerberus. Both mCer-1 and Xcer appear to belong to the cystine knot superfamily, which includes TGF beta s and BMPs. In Xenopus animal cap assays, mCer-1 and Xcer induced cement glands and markers of anterior neural tissue and endoderm, characteristic of BMP inhibition. Furthermore, both antagonised the ventrolateral mesoderm-inducing activity of coexpressed BMP4. In mouse embryos, mCer-1 was expressed at early gastrulation in a stripe of primitive endoderm along the future anterior side of the egg cylinder, a region essential for anterior patterning. A second phase of expression was detected in anterior embryonic mesendoderm, and by late-streak stages most of the anterior half of the embryo was positive, except for the node and cardiac progenitors. Expression was later seen in the cranial portion of the two most-recently formed somites and in two stripes within presomitic mesoderm. In embryos lacking Otx2, a homeogene with a demonstrated role in anterior patterning, mCer-1 was still expressed in an anterior zone, although often abnormally. The data suggest that mCer-1 shares structural, functional, and expression characteristics with Xcer and may participate in patterning the anterior of the embryo and nascent somite region, in part, through a BMP-inhibitory mechanism.

Amino Acid Sequence↗
PubMed1995

Different amyloidogenic peptides share a similar mechanism of neurotoxicity involving reactive oxygen species and calcium.

The amyloid beta-peptide (A beta) that accumulates as insoluble plaques in the brains of Alzheimer's victims can be neurotoxic, by a mechanism that may involve generation of reactive oxygen species (ROS) and destabilization of cellular calcium homeostasis. We now provide evidence that the mechanism of neurotoxicity of two other amyloidogenic peptides (APs), human amylin and beta 2-microglobulin, also involves induction of ROS and elevation of [Ca2+]i. Human amylin, beta 2-microglobulin and A beta 1-40 all caused significant death of neurons in rat hippocampal cell cultures during 24-48 h exposure periods. Rat amylin, a non-AP, was not neurotoxic. Each AP caused an elevation of rest [Ca2+]i during a 20 h exposure period, and promoted a sustained elevation of [Ca2+]i following exposure to glutamate which was significantly greater than controls. Each AP induced accumulation of ROS in neurons which preceded elevation of [Ca2+]i. Several antioxidants, including propyl gallate, vitamin E and the spin-trapping compound N-tert-butyl-alpha-phenylnitrone attenuated the elevation of [Ca2+]i and neurotoxicity induced by the peptides. The data indicate that different APs share a common mechanism of neurotoxicity involving free radical accumulation and destabilization of [Ca2+]i homeostasis.

Amyloid↗
PubMed2004

[Quality assurance of analytical methods to guarantee the reliability of medical decision levels for interpretation of clinical laboratory data].

We sought to investigate the effects of measurement errors on the evaluation of biological variations in healthy subjects. To this end, we analyzed the allowable limits of analytical error which can guarantee the reliability of medical decision levels for interpretation of clinical laboratory data. As a conclusion, we suggest that one-half or less of biological intra-individual variations is appropriate as the criterion for an allowable limit of error to be applied in health check-ups, and this value is in agreement with those in previous reports. If this criteria as the marker for intra-laboratory imprecision is met, a given institute should be able to evaluate time series change follow up of individual data. If the reference interval of laboratory data for disease screening is shared by different institutes, the criterion of 1/4 or less of a biological inter pulse intra-individual variation should be appropriate. This criterion appears to be the goal to be achieved for analytical inter-laboratory variations. On the other hand, as for the criterion for measurement errors which guarantees disease identification based on the cut-off value, a criterion of 1/4 or less of biological inter-pulse intra-individual variation appears to be appropriate, taking into consideration measurement errors which did not influence false-positive or false-negative rates of disease identification. The value turned out to be the same as the limit for the screening of disease. In this study, we considered allowable limits of error in the vicinity of reference value concentrations. However, it will be necessary to set separately the criteria for data in abnormal ranges.

Clinical Laboratory Techniques↗