Selecting subjects for participation in clinical research: one sphere of justice.
Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer's theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to be justified by trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research. (+info)
Why are workers uninsured? Employer-sponsored health insurance in 1997.
This study examines the number of workers in firms offering employee health plans, the number of workers eligible for such plans, and participation in employer-sponsored insurance. Data from the February 1997 Contingent Worker Supplement to the Current Population Survey indicate that 10.1 million workers are employed by firms offering insurance but are not eligible. Not all of these workers are eligible for coverage, most often because of hours of work. Our results indicate that 11.4 million workers rejected coverage when it was offered. Of those, 2.5 million workers were uninsured. Workers cited high cost of insurance most often as the primary factor for refusing coverage. (+info)
User fees, self-selection and the poor in Bangladesh.
The widespread uncontrolled introduction of user fees in any developing country is likely to have a disastrous impact on poorer patients. Furthermore, traditional targeting schemes aimed at their exemption are often expensive, difficult to administer and ineffective at reaching those in greatest need. This research study examines how user fees can raise revenue and target poorer patients, under the right market conditions, without resorting to costly targeting schemes. The authors draw their findings from case studies of cost recovery in the health and population sectors in Bangladesh. The mechanism suggested in the paper is to use self-selection. It is argued that under certain market conditions poorer patients will choose the health-care option that is appropriate to their means. They will thus identify themselves as poor without having to be selected or tested by an independent authority. This self-selection allows the relevant authorities to cross-subsidize their market choice by over-charging the non-poor in other segments of the market. (+info)
Massachusetts Medicaid and the Community Medical Alliance: a new approach to contracting and care delivery for Medicaid-eligible populations with AIDS and severe physical disability.
This paper discusses the origins and experiences of the Community Medical Alliance (CMA), a Boston-based clinical care system that contracts with the Massachusetts Medicaid program on a fully capitated basis to pay for and deliver a comprehensive set of benefits to individuals with advanced AIDS and individuals with severe disability. Since 1992, the program has enrolled 818 individuals with either severe disability, AIDS, mental retardation, or general SSI-qualifying disability. Under a fee-for-service system, these two groups had received fragmented care. The capitated CMA program emphasizes patient education and self-management strategies, social support and mental health services, and a team approach to healthcare delivery that has reoriented care to primary care physicians, homes, and communities. (+info)
Device evaluation and coverage policy in workers' compensation: examples from Washington State.
Workers' compensation health benefits are broader than general health benefits and include payment for medical and rehabilitation costs, associated indemnity (lost time) costs, and vocational rehabilitation (return-to-work) costs. In addition, cost liability is for the life of the claim (injury), rather than for each plan year. We examined device evaluation and coverage policy in workers' compensation over a 10-year period in Washington State. Most requests for device coverage in workers' compensation relate to the diagnosis, prognosis, or treatment of chronic musculoskeletal conditions. A number of specific problems have been recognized in making device coverage decisions within workers' compensation: (1) invasive devices with a high adverse event profile and history of poor outcomes could significantly increase both indemnity and medical costs; (2) many noninvasive devices, while having a low adverse event profile, have not proved effective for managing chronic musculoskeletal conditions relevant to injured workers; (3) some devices are marketed and billed as surrogate diagnostic tests for generally accepted, and more clearly proven, standard tests; (4) quality oversight of technology use among physicians may be inadequate; and (5) insurers' access to efficacy data adequate to make timely and appropriate coverage decisions in workers' compensation is often lacking. Emerging technology may substantially increase the costs of workers' compensation without significant evidence of health benefit for injured workers. To prevent ever-rising costs, we need to increase provider education and patient education and consent, involve the state medical society in coverage policy, and collect relevant outcomes data from healthcare providers. (+info)
Design and results of the antiarrhythmics vs implantable defibrillators (AVID) registry. The AVID Investigators.
BACKGROUND: The Antiarrhythmics Versus Implantable Defibrillators (AVID) Study compared treatment with implantable cardioverter-defibrillators versus antiarrhythmic drugs in patients with life-threatening ventricular arrhythmias (VAs). AVID maintained a Registry on all patients, randomized or not, with any VA or unexplained syncope who could be considered for either of the treatment strategies. Trial-eligible arrhythmias were the categories of VF cardiac arrest, Syncopal VT, and Symptomatic VT, below. METHODS AND RESULTS: Of 5989 patients screened, 4595 were registered and 1016 were randomized. Mortality follow-up through 1996 was obtained on the 4219 Registry patients enrolled before 1997 through the National Death Index. Crude mortality rates (mean+/-SD, follow-up, 16.9+/-11.5 months) were: VF cardiac arrest, 17.0% (n=1399, 238 deaths); Syncopal VT, 21.2% (n=598, 127 deaths); Symptomatic VT, 15.8% (n=1065, 168 deaths); Stable (asymptomatic) VT, 19.7% (n=497, 98 deaths); VT/VF with transient/correctable cause, 17.8% (n=270, 48 deaths); and Unexplained syncope, 12.3% (n=390, 48 deaths). CONCLUSIONS: Patients with seemingly lower-risk or unknown-risk VAs (asymptomatic VT, and VT/VF associated with a transient factor) have a (high) mortality similar to that of higher-risk, AVID-eligible VAs. The similar (and poor) prognosis of most patients with VT/VF suggests the need for reevaluation of a priori risk grouping and raises the question of the appropriate arrhythmia therapy for a broad range of patients. (+info)
State intervention in medical care: types, trends and variables.
This article attempts to develop some of the basic elements for a theory of state intervention in medical care. First, a typology of state intervention is proposed based on two dimensions: the form of state control over the production of medical services and the basis for eligibility of the population. The resulting twelve types provide a means of describing national patterns of state intervention at a given point in time. Next, in order to analyse the changing patterns of state intervention in medical care over time, changes in state control and population coverage are used to construct three hypothetical 'paths' of state intervention, which may serve to depict broad historical trends in major groups of countries. In the final section, several variables are analysed according to their expected effect on the patterns of convergence and divergence in the form and degree of state intervention between countries. This cross-national comparative perspective is offered as a strategy for building a theory capable of explaining state intervention, a process that, to a large extent, informs the medical experience of today. (+info)
Integrating healthcare for older populations.
The complex array of needs posed by older adults has frequently produced fragmentation of care in traditional fee-for-service systems. Integration of care components in newer health systems will maximize patient benefits and organizational efficiency. This article outlines the major issues involved in integration of care for older populations. A health system must integrate its care of older adults in many ways: among providers, both in primary care and specialty services; with community-based sources of care; and across sites of care (clinic, hospital, emergency department, and nursing home). Integrating reimbursement structures for various services will serve to create a client-oriented system, as opposed to a finance-centered system, thereby enhancing coordination of care. The extent to which two experimental comprehensive systems, PACE (Program of All-inclusive Care of the Elderly) and SHMO II (Social Health Maintenance Organization), have achieved clinical and financial integration are discussed in detail. Healthcare organizations are encouraged to create integrated models of care and to study the effects of integration on patient outcomes. (+info)