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A case for the adoption of pharmacoeconomic guidelines in Japan.

In recent years, more and more Japanese pharmaceutical companies have been submitting pharmacoeconomic data to the government, following the official request that such data may help in setting pharmaceutical prices. The companies have cooperated because, by doing so, they could influence pricing decisions for new products. However, the quality of these data at present is considered to be poor and heavily biased. The introduction of pharmacoeconomic guidelines that outline a set of standardised factors to be included in evaluations are necessary, so that an appropriate comparison of the cost effectiveness of the many new drugs that are introduced into the Japanese market each year can be made. In addition to supporting the development of standardised guidelines, the Ministry of Health and Welfare should clarify how pharmacoeconomic data are to be used to aid policy decisions and also mandate the publication of pharmacoeconomic data.

Drug Costs↗

Using encounter data from Medicaid HMOs for research and monitoring.

Complete encounter data from Medicaid HMOs are necessary to monitor patient access to care, compute risk-adjusted payments, and estimate savings from managed care. Encounter data from TennCare for 1996 and 1997 appear to be incomplete. This is the case despite state review of data quality, financial sanctions for Medicaid HMOs that appeared to be submitting incomplete data, and a preliminary assessment of encounter data for samples of two Medicaid enrollee subgroups suggesting that the encounter data might be reasonably complete. Although all states are required to submit Medicaid encounter data to the government, most states currently produce incomplete encounter data.

Cost-Benefit Analysis↗

Accident epidemiology and the U.S. chemical industry: accident history and worst-case data from RMP*Info.

This article reports on the data collected on one of the most ambitious government-sponsored environmental data acquisition projects of all time, the Risk Management Plan (RMP) data collected under section 112(r) of the Clean Air Act Amendments of 1990. This RMP Rule 112(r) was triggered by the Bhopal accident in 1984 and led to the requirement that each qualifying facility develop and file with the U.S. Environmental Protection Agency a Risk Management Plan (RMP) as well as accident history data for the five-year period preceding the filing of the RMP. These data were collected in 1999-2001 on more than 15,000 facilities in the United States that store or use listed toxic or flammable chemicals believed to be a hazard to the environment or to human health of facility employees or off-site residents of host communities. The resulting database, RMP*Info, has become a key resource for regulators and researchers concerned with the frequency and severity of accidents, and the underlying facility-specific factors that are statistically associated with accident and injury rates. This article analyzes which facilities actually filed under the Rule and presents results on accident frequencies and severities available from the RMP*Info database. This article also presents summaries of related results from RMP*Info on Offsite Consequence Analysis (OCA), an analytical estimate of the potential consequences of hypothetical worst-case and alternative accidental releases on the public and environment around the facility. The OCA data have become a key input in the evaluation of site security assessment and mitigation policies for both government planners as well as facility managers and their insurers. Following the survey of the RMP*Info data, we discuss the rich set of policy decisions that may be informed by research based on these data.

Accidents↗

Information, market government, and health policy: a study of health data organizations in the states.

Information is essential to the success of market-oriented policies. Information on health care costs and quality is collected and distributed by state governments through health data organizations (HDOs) to enhance competition and lower costs in the medical industry and to improve consumer choice among medical alternatives. This article examines the information collected, produced, and distributed by state health data organizations in Colorado and Pennsylvania. Findings reveal that information was not the objective determinant of choice and competition as market-oriented policy designers had hoped. Nor did market-oriented bureaucracies produce and distribute data readily accessible for public choice. Instead, information produced and distributed by these HDOs was the result of political and bureaucratic exercises that conform much more to classic interest group policymaking and captured bureaucracies than to contemporary market-oriented government ideals. The findings underscore the extraordinary difficulties facing federal-level policy designers as they contemplate introducing market-oriented health care policies on the national level.

Colorado↗

MetaServe: a lightweight, metadata-aware governance and delivery layer for pre-publication research omics data.

BACKGROUND: Institutional research teams and core facilities routinely manage pre-publication omics datasets that span heterogeneous file types, nested project structures, and multiple downstream uses. Public repositories mainly support post-publication dissemination, while workflow systems and enterprise data platforms do not directly provide a lightweight governance and delivery layer for internal research assets. RESULTS: We present MetaServe, an open-source governance and delivery layer for pre-publication research assets in institutional multi-omics settings. MetaServe registers and delivers heterogeneous assets, including sequencing files, processed matrices, imaging data, analysis-ready objects, tabular files, and documents, without requiring repository-grade standardization. Its metadata-aware design combines file-type recognition, partial automatic extraction for selected formats, manually supplied project and biological annotations, and indexed faceted retrieval. MetaServe supports authenticated web download, viewer-oriented handoff for compatible services such as cellxgene, and path-manifest export for downstream workflows under shared-storage assumptions. The current implementation combines role-based controls, explicit file-level sharing, path-constrained delivery, and operational traceability to support controlled institutional access. MetaServe has been deployed at the Chinese Institutes for Medical Research (CIMR) as part of an institutional multi-omics data-management system. CONCLUSIONS: MetaServe provides a practical layer between institutional storage and downstream analytical platforms for pre-publication research data. Its contribution is the integration of lightweight metadata-aware registration, permission-aware retrieval, and controlled delivery for heterogeneous institutional omics assets. Rather than replacing workflow engines, public repositories, or enterprise-scale research data platforms, MetaServe offers a deployable governance layer for core facilities and collaborative teams that need structured discovery and traceable delivery before public deposition or manuscript release.

Metadata↗

RESEARCH: Comparison of Temporal Trends in Ambient and Compliance Trace Element and PCB Data in Pool 2 of the Mississippi River, USA, 1985-1995.

/ The Intergovernmental Task Force on Monitoring has suggested studies on ambient (in-stream) and compliance (wastewater) data to determine if monitoring can be reduced locally or nationally. The similarity in temporal trends between retrospective ambient and compliance water-quality data collected from Pool 2 of the Mississippi River, USA, was determined for 1985-1995. Constituents studied included the following trace elements: arsenic (As), cadmium (Cd), chromium (Cr), hexavalent chromium (Cr(6+)), copper (Cu), lead (Pb), mercury (Hg), nickel (Ni), selenium (Se), zinc (Zn), and polychlorinated biphenyls (PCBs). Water-column, bed-sediment, and fish-tissue (fillets) data collected by five government agencies comprised the ambient data set; effluent data from five registered facilities comprised the compliance data set. The nonparametric Mann-Kendall trend test indicated that 33% of temporal trends in all data were statistically significant (P < 0.05). Possible reasons for this were low sample sizes, and a high percentage of samples below the analytical detection limit. Trends in compliance data were more distinct; most trace elements decreased significantly, probably due to improvements in wastewater treatment. Seven trace elements (Cr, Cd, Cu, Pb, Hg, Ni, and Zn) had statistically significant decreases in wastewater and portions of either or both ambient water and bed sediment. No trends were found in fish tissue. Inconsistency in trends between ambient and compliance data were often found for individual constituents, making overall similarity between the data sets difficult to determine. Logistical differences in monitoring programs, such as varying field and laboratory methods among agencies, made it difficult to assess ambient temporal trends.KEY WORDS: Mann-Kendall trend test; Ambient data; Compliance data; Trace elements; PCBs, Mississippi Riverhttp://link.springer-ny.com/link/service/journals/00267/bibs/24n4p497.html</HEA

Journal Article↗

Principles of structured data entry applied to reference sources.

Our Structured Data Entry application makes use of a domain specific data model. The principles governing the modeling of this data model, are similar to the requirements of the criteria underlying taxonomic systems. Using the DSM-IV as reference source to create a data model for psychiatry, revealed a number of flaws in the criteria of this system, which potentially influence the reliability and validity of this taxonomic system. We conclude that the modeling process provides us with a powerful tool which can be used during the revision process of such systems.

Child↗

Healthcare reform: current and proposed approaches.

PURPOSE/OBJECTIVES: To explain some of the healthcare reforms currently under consideration by the U.S. Congress. DATA SOURCES: Published reports, government documents, and journal articles. DATA SYNTHESIS: Healthcare reforms are being proposed to address the issues of cost containment, universal access, and quality of care. Elements of the current and proposed healthcare reform plans are reviewed and clarified. CONCLUSIONS: The implementation of some sort of reform seems inevitable; however, the design of the final package will depend on a variety of financial, political, and social pressures. IMPLICATIONS FOR NURSING PRACTICE: If nurses are aware of the proposed changes, they can participate as decision makers, articulate the rules as consumers, and understand the issues as providers.

Cost Control↗

Proportion attributable to medical care of the reduction in stomach cancer deaths in Miyagi, Japan.

To estimate the contribution of medical care to the reduction in stomach cancer deaths, the trends of incidence and death rates were compared from 1960 to 1970 and from 1970 to 1980 in Miyagi, Japan. The mortality data were derived from the reports by Miyagi Prefectural Government. The incidence data from the Miyagi Prefectural Cancer Registry were used after being adjusted by the proportion of DCO (death certificate only), which is one of the indices of the reliability of the cancer registry. The time lag of 1.2 years was considered when these trends were compared. The proportion attributable to medical care of the reduction from 1960 to 1970 was estimated to be 13.6% for males and 8.2% for females in those 40 years of age or older. The proportion from 1970 to 1980 was estimated to be 17.9% for males and 11.0% for females. Medical care reduced stomach cancer deaths, to be 17.9% for males and 11.0% for females. Medical care reduced stomach cancer deaths, which exceeded the decrease in the total incidence, although it was not possible to estimate the proportions attributed to early detection and to improvement of the treatment methods.

Adult↗

A case of Parturiunt montes, nascetur ridiculus mus? the BMA Nutrition Committee 1947-1950 and the political disengagement of nutrition science.

During spring 1947, there was a controversy about the consequences for health of food rationing in Britain; among the issues at stake being the accusation that government departments were failing to release relevant data. The British Medical Association (BMA) responded by establishing a Nutrition Committee to investigate the effects of rationing. Leading members of the BMA expected the committee to intervene decisively in the debate, presenting the medical profession as protectors of the people. The committee, however, was dominated by officials and others who were concerned with presenting the government's record in a good light. Furthermore, by the time the committee reported, the food situation had improved. In the event, the BMA's Nutrition Report was deemed a success if it was received quietly by the press. The deliberations of the committee had involved the controlled release of government data to interested parties, and took place during a period of transition in the government's work in nutrition, from comprehensive emergency intervention toward routine peacetime surveillance. By providing a new set of standards that were used for measuring the adequacy of diets as revealed by the annual National Food Survey, the report contributed to the establishment of the postwar modus operandi of nutrition science and the peacetime system for monitoring the health of the nation.

Advisory Committees↗

The need for family planning and safe abortion services among women sex workers seeking STI care in Cambodia.

In Cambodia, clinics established for the prevention and management of sexually transmitted infections (STIs) in women sex workers do not address other reproductive health services. The aim of this study was to assess the need for more comprehensive sexual and reproductive health services for women sex workers in Cambodia. In January 2000, relevant documents were reviewed, interviews with key informants carried out and group interviews with women sex workers conducted. Medical records from women sex workers were also reviewed and some data collected prospectively in one government STI clinic. Interviews with the women and data from the government clinic indicated that excluding condoms, a very low proportion of women sex workers were currently using a modern contraceptive method--5% of 38 women and 1.6% of 632 women, respectively. Induced abortion was widely used but was perceived to be risky and costly. Data from a mobile team intervention and the government clinic respectively showed that 25.5% (n = 1744) and 21.9% (n = 588) of women sex workers reported at least one previous induced abortion. These findings reveal the need for accessible contraception and safe abortion services among sex workers in Cambodia, and raise the issue of the reproductive rights and reproductive health needs of women sex workers in general.

Abortion, Legal↗

Regulating pesticides in the UK: a case study of risk management problems relating to the organophosphate diazinon.

OBJECTIVES: (1) To assess aspects of occupational and related environmental health risk assessment and risk management decisions of UK regulatory bodies on diazinon used in sheep dip; and (2) to benchmark those decisions against 'the public health precautionary approach'. METHODS: Analysis of diazinon health and safety data available within Government Departments, industry and from users in animal husbandry practice. RESULTS: (1) Data on diazinon produced by the manufacturing companies for the UK pesticide regulatory agencies are not fully transparent; (2) UK regulatory health and safety processes assume accuracy of manufacturer's data and information provided on personal protective equipment (PPE) and application effectiveness; (3) data available reveal gaps and problems with diazinon toxicity, PPE and application methods; and (4) little published evidence shows that industry followed up the health of dippers after product registration or that government departments adopted a public health approach to regulation. CONCLUSIONS: Diazinon sheep dip illustrates the need for the application of a rigorous precautionary principle in both initial registration and later monitoring of chemicals.

Animals↗

Using health outcomes data to inform decision-making: government agency perspective.

In the developed world, the demand for healthcare is rising faster than supply, so that governments are faced with the need to allocate limited resources for maximum benefit. Many governments are responding to these pressures by developing health technology assessment agencies, which evaluate the cost effectiveness of new pharmaceutical and medical products relative to existing interventions. In England and Wales, the agency concerned with health technology assessment is the National Institute for Clinical Excellence (NICE). NICE brings together evidence of clinical and cost effectiveness to judge the value of the treatment relative to alternative uses of National Health Service (NHS) resources and makes recommendations on use of the treatment by the NHS in England and Wales. NICE evaluates technologies where they may result in significant impact on NHS resources or key healthcare policy. The health technology assessment includes a review of the clinical effectiveness, cost effectiveness and service impact of the technology under consideration. This health technology assessment report, together with submissions from the technology manufacturer, and patient and healthcare professionals groups, is then considered by an appraisal committee that formulates guidance to the NHS and is ultimately published by NICE. A number of countries have formal guidelines on the use of outcome measures and economic evaluations in the submissions required for health technology assessment prior to market access. These guidelines vary in both the detail and level of mandatory requirement to be followed by technology manufacturers. NICE has recently updated its guidance to technology manufacturers on their submissions. These guidelines, developed in consultation with the healthcare industry, provide detailed specification of the requirements of NICE for health outcomes data and economic evaluation. These details are described in more detail in this paper.

Biomedical Technology↗

Genetic privacy and the law: an end to genetics exceptionalism.

While the proliferation of human genetic information promises to achieve many public benefits, the acquisition, use, retention, and disclosure of genetic data threatens individual liberties. States (and to a lesser degree, the federal government) have responded to the anticipated and actual threats of privacy invasion and discrimination by enacting several types of genetic-specific legislation. These laws emphasize the differences between genetic information and other health information. By articulating these differences, governments afford genetic data an "exceptional" status. The authors argue that genetic exceptionalism is flawed for two reasons: (1) strict protections of autonomy, privacy, and equal treatment of persons with genetic conditions threaten the accomplishment of public goods; and (2) there is no clear demarcation separating genetic data from other health data; other health data deserve protections in a national health information infrastructure. The authors present ideas for individual privacy protections that balance the societal need for genetic information and the claims for privacy by individuals and families.

Databases, Nucleic Acid↗

The short-term financial costs of abnormal Pap smears to women and government in Australia.

Using data collected from a private Canberra colposcopy service, we examined the direct costs, to women and government, of the gynaecological care of women with cervical cytological abnormalities and determine the potential savings of implementing the Commonwealth recommendations for the clinical care of women with screen-detected abnormalities. We performed a case note audit of 502 women who first attended a gynaecologist because of an abnormal Pap smear between 1 January 1989 and 30 April 1990. The smear resulting in their referral--their presenting smear--was categorised as No CIN (showing no evidence of cervical intraepithelial neoplasia), CIN 1, CIN 2 and CIN 3. The average costs to government (p for trend < 0.001) and women (p for trend = 0.006) increase as the presenting smear increases in severity; the median costs to government (p for trend < 0.001) and women (p for trend < 0.001) also rose with increasing cytological severity. Treatment of CIN 1 and No CIN accounted for half the costs incurred by government and women. Although costs increase with increasing severity of cytological abnormality, adherence to new Australian guidelines for the gynaecological care of women with screen-detected cervical abnormalities could result in substantial short-term savings to government and women.

Adult↗