A national study of efficiency for dialysis centers: an examination of market competition and facility characteristics for production of multiple dialysis outputs.
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OBJECTIVE: To examine market competition and facility characteristics that can be related to technical efficiency in the production of multiple dialysis outputs from the perspective of the industrial organization model. STUDY SETTING: Freestanding dialysis facilities that operated in 1997 submitted cost report fonns to the Health Care Financing Administration (HCFA), and offered all three outputs--outpatient dialysis, dialysis training, and home program dialysis. DATA SOURCES: The Independent Renal Facility Cost Report Data file (IRFCRD) from HCFA was utilized to obtain information on output and input variables and market and facility features for 791 multiple-output facilities. Information regarding population characteristics was obtained from the Area Resources File. STUDY DESIGN: Cross-sectional data for the year 1997 were utilized to obtain facility-specific technical efficiency scores estimated through Data Envelopment Analysis (DEA). A binary variable of efficiency status was then regressed against its market and facility characteristics and control factors in a multivariate logistic regression analysis. PRINCIPAL FINDINGS: The majority of the facilities in the sample are functioning technically inefficiently. Neither the intensity of market competition nor a policy of dialyzer reuse has a significant effect on the facilities' efficiency. Technical efficiency is significantly associated, however, with type of ownership, with the interaction between the market concentration of for-profits and ownership type, and with affiliations with chains of different sizes. Nonprofit and government-owned Facilities are more likely than their for-profit counterparts to become inefficient producers of renal dialysis outputs. On the other hand, that relationship between ownership form and efficiency is reversed as the market concentration of for-profits in a given market increases. Facilities that are members of large chains are more likely to be technically inefficient. CONCLUSIONS: Facilities do not appear to benefit from joint production of a variety of dialysis outputs, which may explain the ongoing tendency toward single-output production. Ownership form does make a positive difference in production efficiency, but only in local markets where competition exists between nonprofit and for-profit facilities. The increasing inefficiency associated with membership in large chains suggests that the growing consolidation in the dialysis industry may not, in fact, be the strategy for attaining more technical efficiency in the production of multiple dialysis outputs. (+info)
Prevention of malaria in Afghanistan through social marketing of insecticide-treated nets: evaluation of coverage and effectiveness by cross-sectional surveys and passive surveillance.
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Malaria is often a major health problem in countries undergoing war or conflict owing to breakdown of health systems, displacement of vulnerable populations, and the increased risk of epidemics. After 23 years of conflict, malaria has become prevalent in many rural areas of Afghanistan. From 1993 to the present, a network of non-governmental organizations, co-ordinated by HealthNet International, has operated a programme of bednet sales and re-treatment in lowland areas. To examine whether a strategy based on insecticide-treated nets (ITN) is a viable public health solution to malaria, communities were given the opportunity to buy nets and then monitored to determine population coverage and disease control impact. This was carried out using two contrasting methods: cross-sectional surveys and passive surveillance from clinics using a case-control design. Nets were purchased by 59% of families. Cross-sectional surveys demonstrated a 59% reduction in the risk of Plasmodium falciparum infection among ITN users compared with non-users (OR 0.41; 95% CI 0.25-0.66). The passive surveillance method showed a comparable reduction in the risk of symptomatic P. falciparum malaria among ITN users (OR 0.31; 95% CI 0.21-0.47). The cross-sectional method showed a 50% reduction in risk of P. vivax infection in ITN users compared with non-users (OR 0.50; 95% CI 0.17-1.49) but this effect was not statistically significant. The passive surveillance method showed a 25% reduction in the risk of symptomatic P. vivax malaria (OR 0.75; 95% CI 0.66-0.85). ITN appeared to be less effective against P. vivax because of relapsing infections; hence an effect took more than one season to become apparent. Passive surveillance was cheaper to perform and gave results consistent with cross-sectional surveys. Untreated nets provided some protection. Data on socioeconomic status, a potential confounding factor, was not collected. However, at the time of net sales, there was no difference in malaria prevalence between buyers and non-buyers. The abundance of Anopheles stephensi, the main vector, did not appear to be affected by ITN. ITN constitute one of the few feasible options for protection against malaria in chronic emergencies. (+info)
Quality, mainstream services with proactive and targeted outreach: a model of contraceptive service provision for young people.
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INTRODUCTION: High teenage pregnancy rates in the UK reflect low levels of contraceptive use. Young people have a negative perception of contraceptive services and experience significant practical barriers to their use. Dedicated young people's services are considered an effective way to improve access. However it is costly to provide two parallel services (one for older and one for young clients) and competition for resources between two services limits the opening hours of both. In this way access by clients of all ages may be reduced. We have piloted an alternative approach. We provide quality mainstream services (open to clients of all ages) with extended hours and no appointment necessary. This is combined with targeted outreach to facilitate access by the under-25s. The outreach programme includes the development of close links between the clinic and local schools, youth services, social services and voluntary sector organisations. This paper presents one part of the evaluation of this service. METHODS: Patients registering in the 6 months before and 18 months after the development of the new service completed an anonymous questionnaire. This collected demographic details and data on their source of information about the service. RESULTS: The number of clients of all age groups registering at the new service in the first year doubled. The number of new users aged under 16 years increased by 12-fold in the first 18 months. The number of young people citing a school sex education class as their source of information about the clinic increased by more than five-fold. CONCLUSION: This model of contraceptive service provision significantly increases service access by young people. It represents an effective alternative to dedicated services for young people. (+info)
The end of an era: what became of the "managed care revolution" in 2001?
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OBJECTIVE: To describe how the organization and dynamics of health systems changed between 1999 and 2001, in the context of expectations from the mid-1990s when managed care was in ascendance, and assess the implications for consumers and policymakers. DATA SOURCES/STUDY SETTING: Data are from the Community Tracking Study site visits to 12 communities that were randomly selected to be nationally representative of metropolitan areas with 200,000 people or more. The Community Tracking Study is an ongoing effort that began in 1996 and is fielded every two years. STUDY DESIGN: Semistructured interviews were conducted with 50-90 stakeholders and observers of the local health care market in each of the 12 communities every two years. Respondents include leaders of local hospitals, health plans, and physician organizations and representatives of major employers, state and local governments, and consumer groups. First round interviews were conducted in 1996-1997 and subsequent rounds of interviews were conducted in 1998-1999 and 2000-2001. A total of 1,690 interviews were conducted between 1996 and 2001. DATA ANALYSIS METHODS: Interview information was stored and coded in qualitative data analysis software. Data were analyzed to identify patterns and themes within and across study sites and conclusions were verified by triangulating responses from different respondent types, examining outliers, searching for disconfirming evidence, and testing rival explanations. PRINCIPAL FINDINGS: Since the mid-1990s, managed care has developed differently than expected in local health care markets nationally. Three key developments shaped health care markets between 1999 and 2001: (1) unprecedented, sustained economic growth that resulted in extremely tight labor markets and made employers highly responsive to employee demands for even fewer restrictions on access to care; (2) health plans increasingly moved away from core strategies in the "managed care toolbox"; and (3) providers gained leverage relative to managed care plans and reverted to more traditional strategies of competing for patients based on services and amenities. CONCLUSIONS: Changes in local health care markets have contributed to rising costs and created new access problems for consumers. Moreover, the trajectory of change promises to make the goals of cost-control and quality improvement more difficult to achieve in the future. (+info)
Changes in hospital competitive strategy: a new medical arms race?
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OBJECTIVE: To describe changes in hospitals' competitive strategies, specifically the relative emphasis placed on strategies for competing along price and nonprice (i.e., service, amenities, perceived quality) dimensions, and the reasons for any observed shifts. METHODS: This study uses data gathered through the Community Tracking Study site visits, a longitudinal study of a nationally representative sample of 12 U.S. communities. Research teams visited each of these communities every two years since 1996 and conducted between 50 to 90 semistructured interviews. Additional information on hospital competition and strategy was gathered from secondary data. PRINCIPAL FINDINGS: We found that hospitals' strategic emphasis changed significantly between 1996-1997 and 2000-2001. In the mid-1990s, hospitals primarily competed on price through "wholesale" strategies (i.e., providing services attractive to managed care plans). By 2000-2001, nonprice competition was becoming increasingly important and hospitals were reviving "retail" strategies (i.e., providing services attractive to individual physicians and the patients they serve). Three major factors explain this shift in hospital strategy: less than anticipated selective contracting and capitated payment; the freeing up of hospital resources previously devoted to horizontal and vertical integration strategies; and, the emergence and growth of new competitors. CONCLUSION: Renewed emphasis on nonprice competition and retail strategies, and the service mimicking and one-upmanship that result, suggest that a new medical arms race is emerging. However, there are important differences between the medical arms race today and the one that occurred in the 1970s and early 1980s: the hospital market is more concentrated and price competition remains relatively important. The development of a new medical arms race has significant research and policy implications. (+info)
International Conference on Harmonisation; guidance on electronic common technical document specification; availability. Notice.
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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M2 eCTD: Electronic Common Technical Document Specification." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance defines the means for industry-to-agency transfer of regulatory information that will facilitate the creation, review, life cycle management, and archiving of the electronic submission. The guidance is intended to assist industry in transferring electronically their marketing applications for human drug and biological products to a regulatory authority. (+info)
A 6-month pilot of a collaborative clinic between genitourinary medicine services and a young persons' sexual health clinic.
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OBJECTIVE: To investigate whether situating a genitourinary medicine (GUM) clinic within a Brook centre is successful in attracting a younger client group than that traditionally seen in GUM clinics within hospitals. DESIGN: A descriptive study of a 6-month pilot clinic. SETTING: Brook in Manchester. A community clinic providing sexual health advice to clients under the age of 25 years. With the collaboration of Withington Hospital GUM Department, Manchester. PARTICIPANTS: All clients under the age of 25 years attending the pilot GUM clinic. MAIN OUTCOME MEASURES: The age of the clients attending and the diagnosis made. RESULTS: A total of 137 visits were made by 93 clients. Under-16s comprised 6% of all visits compared to 1.5% at Withington GUM clinic (adjusted for the under-25s) and 12% at Brook. Far more Chlamydia trachomatis was seen (34% of all clients) than in a traditional GUM clinic (18% of all clients). Contact tracing resulted in 82% of named contacts being traced. CONCLUSION: The pilot clinic was successful in attracting a much younger client group than a traditional hospital-based service. (+info)
Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule.
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The Food and Drug Administration (FDA) is amending its patent submission and listing requirements for new drug applications (NDAs). The final rule clarifies the types of patents that must and must not be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants submit only appropriate patents. The final rule also revises the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain other new drug applications, known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act (the act). In certain situations, Federal law bars FDA from making the approval of certain ANDA and 505(b)(2) applications effective for 30 months if the applicant has certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder then brings suit for patent infringement. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each ANDA and 505(b)(2) application. The final rule will make the patent submission and listing process more efficient as well as enhance the ANDA and 505(b)(2) application approval processes. (+info)