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Long-term solutions for the problem of vaccine shortages.

During the past few years, vaccine shortage has been a serious problem affecting both developed and developing countries. The explanation is linked to the poor economic value associated with vaccines. Although every year the routine use of vaccines saves millions of lives, the economic value associated with them is negligible, especially if compared with the pharmaceutical market. This situation disincentives private investment, which prefers to focus on more profitable business. To overcome these problems, it is essential to recognise that the intangible value of vaccination (the value of being alive and healthy) represents the real value provided by vaccines. If the intangible value were to be included in the vaccine price, vaccines would become as attractive as other pharmaceuticals. While waiting for a long-term sustainable solution, public-private partnerships represent a way to increase vaccine value awareness and to decrease the risk for vaccine manufacturers. This article will provide examples of how public-private partnerships both in developed and developing countries have been established to handle specific problems concerning vaccination.

Cost-Benefit Analysis↗

Impact of a Medicaid primary care provider and preventive care on pediatric hospitalization.

OBJECTIVE: This study evaluates the impact that a Medicaid managed care program had on avoidable hospitalization, a form of health care misuse that we hypothesize can be reduced by improved access to and quality of primary care in the context of a managed care program. Ambulatory care sensitive (ACS) hospitalizations, a previously defined categorization of hospitalization, as well as all pediatric hospitalizations were also studied. INTERVENTION: The Maryland Access to Care (MAC) was a fee-for-service, gatekeeper, Medicaid managed care program with assigned primary medical providers and required Early Periodic Screening, Diagnosis, and Treatment (EPSDT) examinations. Medicaid managed care elements include: 1) assignment to primary medical provider (PMP) either by voluntary choice or mandatory enrollment of eligible Aid to Families With Dependent Children (AFDC), Medical Assistance (medical needy), and Supplemental Security Income; 2) a medical home accessible 24 hours a day, 7 days a week; 2) PMP must authorize emergency department (ED), inpatient, and specialty care but there were no disincentives to PMP for referral; 3) fee-for-services reimbursement (with a physician rate increase) for primary care, authorized specialist care, and hospitalization; and 4) an on-line eligibility verification system was available to all medical providers. Pre-enrollment as well as publicity allowed MAC to be phased in rapidly, resulting in 70% to 80% enrollment by the end of the first program year. DESIGN: The design of this study is that of a pre- and postevaluation of the MAC program using Medicaid claims analysis of data 3 years pre-MAC and 2 years post-MAC. In multivariate analyses, this study also compares MAC-enrolled children to non-MAC-enrolled children (before and after MAC began) to estimate the impact of MAC enrollment while controlling for potential confounders. SETTING: State of Maryland from 1989 to 1993. PATIENTS: MAC-eligible children 18 years of age. OUTCOME MEASURES: Claims data were used to define avoidable hospitalization (based on ambulatory care received before hospitalization), to define ACS hospitalizations (based on the International Classification of Diseases-Clinical Modification, Ninth Revision [ICD-9-CM] codes), and to summarize use of ambulatory and inpatient care. ACS hospitalizations have been defined as those conditions for which timely and effective primary care can help to reduce the risk of hospitalizations. These are based solely on ICD-9-CM discharge codes that were studied by Billings and Teicholz in 1990 and used by an Institute of Medicine report in 1993. Examples include hospital discharge diagnoses of asthma (ICD-9-CM = 493), gastroenteritis (ICD-9-CM = 558.9), and dehydration (ICD-9-CM = 276.5). Usage measures, such as preventive care visits or ED visits, were created using Maryland Medicaid codes, Current Procedural Terminology codes, and ICD-9-CM codes. Linear regression was used to model trend. Logistic regression was used to model the probability of ambulatory and inpatient care given MAC enrollment and other covariates. First, logistic regression was used to predict the probability of any ambulatory care use among all MAC-eligible children during a quarter to model changes in access that may have occurred during MAC. Then, among users of ambulatory care or inpatient care, logistic regression was used to predict the probability of hospitalization. RESULTS: Most of the children studied were in the AFDC program, about half were African-American, one third resided in Baltimore City, and 9% of children had ICD-9-CMs reflecting chronic disease. The mean percentage of time children were MAC-eligible per quarter was 91%. Only 5% of children were continuously enrolled for all 20 quarters included in this study. Per-capita ambulatory care visits, especially per-capita preventive care visits, increased significantly during the study period (b = 0.003) whereas per-capita ED visits did not change. The mean n

Adolescent↗

Reimbursement for pediatric diabetes intensive case management: a model for chronic diseases?

OBJECTIVE: Current reimbursement policies serve as potent disincentives for physicians who provide evaluation and management services exclusively. Such policies threaten nationwide availability of care for personnel-intensive services such as pediatric diabetes. This report describes an approach to improving reimbursement for highly specialized, comprehensive pediatric diabetes management through prospective contracting for services. The objective of this study was to determine whether pediatric diabetes intensive case management services are cost-effective to the payer, the patient, and a pediatric diabetes program. METHODS: A contract with a third-party payer was created to reimburse for 3 key pediatric diabetes intensive case management components: specialty education, 24/7 telephone access to an educator (and board-certified pediatric endocrinologist as needed), and quarterly educator assessments of self-management skills. Data were collected and analyzed for 15 months after signing the contract. Within the first 15 months after the contract was signed, 22 hospital admissions for diabetic ketoacidosis (DKA) occurred in 16 different patients. After hospitalizations for DKA, all 16 patients were offered participation in the program. All were followed during the subsequent 1 to 15 months of observation. Ten patients elected to participate, and 6 refused participation. Frequency of rehospitalization, emergency department visits, and costs were compared between the 2 groups. RESULTS: Among the 10 participating patients, there was only 1 subsequent DKA admission, whereas among the 6 who refused participation, 5 were rehospitalized for DKA on at least 1 occasion. The 10 patients who participated in the program had greater telephone contact with the team compared with those who did not (16 crisis-management calls vs 0). Costs (education, hospitalization, and emergency department visits) per participating patient were approximately 1350 dollars less than those for nonparticipating patients. Differences between participating and nonparticipating groups included age (participants were of younger age), double-parent households (participants were more likely to be from double parent households), and number of medical visits kept (participants kept more follow-up visits). No differences in duration of diabetes, months followed in the program, sex, or ethnicity were observed. CONCLUSIONS: Contracting with third-party payers for pediatric diabetes intensive case management services reduces costs by reducing emergency department and inpatient hospital utilizations, likely a result of intensive education and immediate access to the diabetes health care team for crisis management. Such strategies may prove to be cost saving not only for diabetes management but also for managing other costly and personnel-intensive chronic diseases.

Adolescent↗

Treatment of hematologic malignancies and solid tumors by inhibiting IGF receptor signaling.

Insulin-like growth factors (IGF) and their receptors (IGF-1R) constitute a complex biologic system implicated in diverse regulatory levels of cell proliferation, viability, differentiation and metabolism. Extensive epidemiologic data have implicated the IGF/IGF-1R pathway in the establishment of human malignancies, consistent with experimental data on the role of this signaling cascade in promoting cell transformation, resistance to apoptosis, metastases and other aspects of the biology of human cancers. However, historically, the IGF/IGF-1R pathway has not been viewed as an attractive target for therapeutic intervention. The widespread IGF-1R expression in normal tissues and its close homology to the insulin receptor had led to the assumption that IGF-1R inhibition would cause unacceptable toxicities in vivo. Even though neutralizing antibodies against human IGF-1R have been efficacious against xenograft tumors, a lack of reactivity against the host rodent receptor has confounded the assessment of its therapeutic index. Furthermore, the lack of a clear understanding of the relevant significance for neoplastic cells in the function of IGF-1R versus other growth factor receptors provided an additional disincentive for the study of this pathway. However, recent reports from the authors' group and others have shown that small molecule inhibitors of tyrosine kinase activity of IGF-1R can be safely and efficaciously administered in vivo in clinically relevant orthotopic models of human neoplasias, such as multiple myeloma. This article reviews the data that validated IGF-1R as a therapeutic target for a broad spectrum of malignancies and provides in vivo proof-of-concept for the use of selective IGF-1R kinase inhibitors as primary antitumor therapy or in synergistic combination as chemosensitizers. These results have not only provided the rationale for clinical trials of small molecule IGF-1R inhibitors, but have also rekindled interest in other therapeutic modalities (e.g., monoclonal antibodies) aimed at suppressing the function of this critical pathway for tumor cell pathophysiology.

Hematologic Neoplasms↗

Living-donor kidney transplantation: a review of the current practices for the live donor.

The first successful living-donor kidney transplant was performed 50 yr ago. Since then, in a relatively brief period of medical history, living kidney transplantation has become the preferred treatment for those with ESRD. Organ replacement from either a live or a deceased donor is preferable to dialysis therapy because transplantation provides a better quality of life and improved survival. The advantages of live versus deceased donor transplantation now are readily apparent as it affords earlier transplantation and the best long-term survival. Live kidney donation has also been fostered by the technical advance of laparoscopic nephrectomy and immunologic maneuvers that can overcome biologic obstacles such as HLA disparity and ABO or cross-match incompatibility. Congressional legislation has provided an important model to remove financial disincentives to being a live donor. Federal employees now are afforded paid leave and coverage for travel expenses. Candidates for renal transplantation are aware of these developments, and they have become less hesitant to ask family members, spouses, or friends to become live kidney donors. Living donation as practiced for the past 50 yr has been safe with minimal immediate and long-term risk for the donor. However, the future experience may not be the same as our society is becoming increasingly obese and developing associated health problems. In this environment, predicting medical futures is less precise than in the past. Even so, isolated abnormalities such as obesity and in some instances hypertension are no longer considered absolute contraindications to donation. These and other medical risks bring additional responsibility in such circumstances to track the unknown consequences of a live-donor nephrectomy.

Humans↗

Minimizing sample size when using exploratory factor analysis for measurement.

Traditional protocol for the determination of an adequate sample size is power analysis. Such a protocol is not useful when the primary hypothesis focuses on psychometric measurement properties. Traditional psychometrics advises that there should be 10 respondents per item. Both hypothetical and real research examples illustrate the usefulness of subsample analysis in determining that a sample size of at least 50 and not more than 100 subjects is adequate to represent and evaluate the psychometric properties of measures of social constructs. The "10 respondents per item" advice builds a sample size disincentive into the research design; it also represents "sample size overkill." Sample-size overkill occurs when the research design specifies a number of cases needed, which is in excess of the number actually needed for a desired inference.

Computer Simulation↗

A major state tobacco tax increase, the master settlement agreement, and cigarette consumption: the California experience.

OBJECTIVES: We evaluated the combined effects on California cigarette consumption of an additional 50 cent per pack state tax imposed by Proposition 10 of January 1999 and a 45 cent per pack increase in cigarette prices stemming from the Master Settlement Agreement (MSA) of November 1998. METHODS: We used quarterly cigarette sales data for the period 1984-2002 to estimate a time-series intervention model adjusting for seasonal variations and time trend. RESULTS: Over the period 1999 through 2002, the combined effect was to reduce cigarette consumption by 2.4 packs per capita per quarter (1.3 billion packs total over the 4-year period) and to raise state tax revenues by $2.1 billion. These effects were similar to the effects of a 25 cent per pack tax increase enacted by Proposition 99 a decade earlier, although with decreased relative effectiveness as measured by percentage of reduction in cigarette consumption divided by percentage of increase in taxation (-0.44 vs -0.60). CONCLUSIONS: A major increase in price through taxation and the MSA provided a strong economic disincentive for smokers in a state with a low smoking prevalence. This effect could be reinforced if part of the MSA payments were devoted to tobacco control programs.

California↗

Issues in national health insurance.

Health insurance, by reducing net price to the consumer and increasing the opportunities for revenue to the provider, has profound effects, among other things, on the volume, content and distribution of services, their prices, and the capacity of providers to produce them. The magnitude and nature of these effects depend, partly, on the design of insurance benefits and, partly, on the nature of the health care system, particularly its current and potential capacity and the methods it uses to pay providers. Those who believe that the unique aim of insurance is to protect against unpredictable expenses attempt to suppress these effects, mainly by imposing financial disincentives to utilization which, in turn, reduce protection for those who need it most. Those who wish to reform the system have a broader range of objectives which include protective efficacy, cost control, quantitative adequacy, qualitative adequacy, efficiency of production, efficiency of allocation, equity, and redistribution of capacity. An analysis of the effects of insurance in the light of these objectives reveals favorable as well as unfavorable consequences. The provision of comprehensive benefits generates the necessity for a fundamental change in the organization of health services, if the advantages are to be fully realized and the disadvantages minimized.

Deductibles and Coinsurance↗

The impact of infection after total hip arthroplasty on hospital and surgeon resource utilization.

BACKGROUND: Deep infection following total hip arthroplasty is a devastating complication for the patient and a costly one for patients, surgeons, hospitals, and payers. The purpose of this study was to compare revision total hip arthroplasty for infection, revision total hip arthroplasty for aseptic loosening, and primary total hip arthroplasty with respect to their impact on hospital and surgeon resource utilization and referral patterns to a tertiary-care hospital. METHODS: Clinical, demographic, and economic data were obtained for twenty-five consecutive patients with an infection after a total hip replacement who underwent a two-stage revision arthroplasty (Group 1) performed by one of two surgeons, between March 2001 and December 2002, at a single institution. Similar data were collected during the same time-period for a cohort of twenty-five consecutive patients who underwent revision of both components because of aseptic loosening (Group 2) and twenty-five consecutive patients who underwent a primary hip arthroplasty (Group 3). Quantitative and categorical variables were compared among the groups. Referral patterns were examined by reviewing the primary diagnosis for all patients referred to our institution for a revision total hip arthroplasty during a five-year period. RESULTS: Revision procedures for infection were associated with longer operative time, more blood loss, and a higher number of complications compared with revisions for aseptic loosening or primary total hip arthroplasty (p < 0.02 for all). Revisions for infection were also associated with a higher total number of hospitalizations, total number of days in the hospital, total number of operations, total hospital costs, total outpatient visits, and total outpatient charges during the twelve-month period following the index procedure (p < 0.001 for all). The incidence of referrals to our institution for a diagnosis of infection following total hip arthroplasty increased significantly over a five-year period (Spearman rank correlation, 1.0; p = 0.0083), while referral rates for revision for causes other than infection remained relatively constant (Spearman rank correlation, 0.500; p = 0.3910). CONCLUSIONS: The treatment of patients with an infection after a total hip arthroplasty is associated with significantly greater hospital and physician resource utilization compared with the treatment of patients who have a revision because of aseptic loosening or who have a primary total hip arthroplasty. We believe that the lack of incremental reimbursement associated with these procedures results in strong financial disincentives for physicians and hospitals to provide treatment for patients with an infection after a total hip arthroplasty.

Adult↗

Levonorgestrel subdermal implants. Contraception on trial.

When they were introduced to the world market in the 1980s, levonorgestrel subdermal implants offered the promise of an exciting alternative to traditional hormonal contraception. They provide highly effective, long-acting protection from pregnancy, without the need for user compliance. Broad acceptability of the drug has been reported throughout the world. Recently, however, the implants have met with opposition. The drug is associated with a variety of adverse effects, and removal of implants can be problematic. Serious events have been reported in women using levonorgestrel subdermal implants, although causal relationships have not been demonstrated. Additionally, concerns have been raised over the potential for coercive use of the drug. Numerous law suits have been filed alleging serious problems with implants. As a result, the drug has received considerable negative media attention. Before the controversy over levonorgestrel subdermal implants erupted, contraceptive development had declined, resulting from limitations to profits and funding, legal threats, and changes in the insurance industry. The levonorgestrel subdermal implant experience may serve to accelerate this trend. While the introduction of levonorgestrel subdermal implants offered an alternative to the current array of medical contraception, its experience may serve to dampen future contraceptive development efforts. Costly litigation and much controversy involving the implants have acted to create disincentives to further research and development of new methods of medical contraception.

Administration, Cutaneous↗

Why nafta failed and what's needed to protect workers' health and safety in international trade treaties.

Labor standards, including occupational health and safety regulations and enforcement, are being subjected to intense downward pressures as a result of fundamental shifts in the global economy. The 1994 North American Free Trade Agreement (NAFTA) was the first trade treaty that attempted to promote and protect workplace health and safety through a "labor side agreement." NAFTA failed to protect workers' health and safety due to the weaknesses of the side agreement's text; the political and diplomatic considerations limiting its implementation; and the failure to recognize and address the economic context, and political consequences of this context, in which the agreement was implemented. Subsequent trade treaties, both bilateral and regional, have not overcome the weaknesses of NAFTA. The treaty components needed to protect workers' health in future trade agreements are: 1) a minimum floor of occupational health and safety regulations; 2) an "upward harmonization" of regulatory standards and actual practice; 3) inclusion of employers so that they have formal responsibility and liability for violations of the standards; 4) effective enforcement of national regulations and international standards; 5) transparency and public participation; and 6) recognition of disparate economic conditions among trading partners and provision of financial and technical assistance to overcome economic disincentives and lack of resources. Also required are continued actions by non-governmental actors, including the workers themselves and civil society organizations.

Journal Article↗

Health service regionalization in New Brunswick, Canada: a bold move.

New Brunswick moved swiftly in 1992 to regionalize hospital and physician services along with the reform and expansion of other health care services. The dissolution of 51 hospital and community health services center boards and the establishment of eight region hospital corporations to oversee services in the seven health regions set the tone for regionalization in the province. The plan provides the flexibility to meet specific regional needs. The initial regionalization of hospital services was followed by the determination of the appropriate number, mix, and distribution of physician resources for each region, also to be managed by the region hospital corporation. The provincial government's central role not only guides the regions, but also uses incentives and disincentives to ensure that regional goals are.met. While regionalization is not new and some components of the New Brunswick plan have been used elsewhere, the effort offers an integrated model for the regionalization of hospital and physician services, with the expansion of complementary services.

Community Health Centers↗

International actors and population policies in India, with special reference to contraceptive policies.

The international population policy agenda has traditionally been dominated by demographically driven population control policies. However, in the population policy development that preceded the International Conference on Population and Development in 1994, people's reproductive needs and rights received more emphasis. The aim of this study was to analyze how the new emphasis in population policies has been interpreted at the country level. In analyzing population policy rhetoric and its practical interpretations in India in 1994, the authors found that the rhetoric was broadening to encompass women's empowerment and reproductive health and that the use of direct method-specific monetary incentives and disincentives for accepting family planning methods was disapproved. However, population policy options were still considered mainly in terms of their ability to reduce fertility. Furthermore, the increased emphasis on the general market agenda was more important than that on reproductive needs and rights in molding population policies, as was evident in the greater stress on cost-recovery systems and nongovernmental actors. The findings suggest that the broader agenda for population policies and reproductive rights has been interpreted so that it can serve the aims of population-growth control and be implemented in the context of more market-oriented social policies and trade liberalization.

Contraception↗

Workplace health and safety: report from Canada.

This article represents a critical analysis of the major policy responses to workplace health and safety in Canada. It examines the deficiencies inherent in the legislative development of Joint Health and Safety Committees in most Canadian jurisdictions, the limitations regarding standard-setting of worker exposure to contaminants, and disincentive for employers to positively improve the workplace because of Workers Compensation legislation. Collective bargaining agreements in Canada have had only limited positive effects, while the ultimate legal sanction of criminal prosecution by the regulatory agencies has weakened enforcement and compliance of existing regulations. There has never been a successful criminal prosecution of an employer in Canada, even for multiple deaths. The article suggests the following four reasons for this "underdevelopment" of occupational health and safety in Canada: the concealment of the dimension of the incidence of industrial disease based on Workers Compensation Board statistics; the application of an incorrect theory of causation of both industrial disease and injury by both managers and government administrators of occupational health and safety programs; the resistance of both senior and middle managers against increased worker participation in both work organization and job design questions; and the general "moral underdevelopment," rather than ignorance, of managers in favoring economic considerations or values at the expense of worker health and safety. In light of the magnitude of the problem and the deficiencies of existing policy approaches, the author proposes the need for greater workplace democratization of production and industry as a necessary and sufficient reform of workplace health and safety.

Accident Prevention↗

Overcoming barriers to access and utilization of hospice and palliative care services in African-American communities.

While there is ample evidence to support the need for hospice and palliative care services for African Americans, only 8% of patients who utilize those services are from African-American communities. The underutilization of end-of-life and palliative care can be attributed to several barriers to service access including incompatibility between hospice philosophy and African-American religious, spiritual, and cultural beliefs; health care disparities; distrust of the medical establishment; physician influence; financial disincentives, and hospice admission criteria. Suggestions for dismantling barriers to care access include developing culturally competent professionals in the health and human services, expanding the philosophy of hospice to include spiritual advisors from client communities, and funding national initiatives to promote improved access to health care at all stages in the life cycle of members of all underserved communities.

Attitude of Health Personnel↗

Sulfonamide residues in pork: past, present, and future.

The Food Safety and Inspection Service (FSIS) of the U. S. Department of Agriculture (USDA) has been involved for a number of years with the problem of sulfonamide residues in pork. In the 1970s, concern was raised regarding the use of sulfonamides when food safety criteria used for premarketing approval of new animal drugs and the safety data base for sulfonamides were found to be inadequate. Regulatory analytical methods for monitoring sulfonamides were developed and put to use by FSIS. With educational efforts by government and industry, by 1980 it was thought that the problem was being solved. In the 1980s, however, the sulfonamide violation rate began to increase; the USDA strengthened its educational programs, developed a rapid test for sulfonamides and pursued regulatory initiatives. By 1987 sulfonamide violations in liver tissue (i.e., greater than .1 ppm) had declined to 3.8%; however, new toxicological information associating sulfamethazine with the development of follicular cell adenomas of the thyroid gland in rats and mice led the FSIS to begin an enhanced sulfamethazine control program in the spring of 1988. The FSIS believes that production quality assurance is the key to prevention. The Agency's initiatives toward this end are designed both to encourage industry accountability and to provide disincentives for violators. The current approaches to the sulfonamide problem hold the clear promise of a satisfactory solution.

Animals↗

The long march: the development of academic general practice in the UK and Ireland.

Academic general practice and primary care is thriving in both the UK and Ireland, as judged by the content and vibrancy of the main annual scientific meetings of the discipline in the two countries. Problems and challenges abound, but the long-term trend is one of steady growth, with gradual increases in capacity and activity. Contributions to undergraduate medical education and to multidisciplinary professional development, and achievements in the UK University Research Assessment Exercise (RAE) show what the discipline is capable of. A major challenge remains the creation and funding of appropriate academic career structures in academic general practice and primary care, removing the current financial disincentives, uncertainties and problems in acquiring both clinical and academic experience. With increased numbers of clinical and non-clinical academics working in general practice and primary care, the discipline is set to play an important role in health service development in both the UK and Ireland.

Biomedical Research↗

Liability for medical expert systems: an introduction to the legal implications.

Some of the possible legal implications of the production, marketing and use of expert systems are examined in this paper. The relevance of a legally useful definition of expert systems, comprising systems designed for use by both laymen and professionals, is related to the distinctions inherent in the legal doctrine underlying provision of goods and provision of services. The liability of the sellers and users of, and contributors to, expert systems are examined in terms of professional malpractice as well as product liability. A recurring theme indicates that legislators may be inclined to restrict possibilities of liability suits in order to avoid disincentives to the creation of expert systems.

Confidentiality↗