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Development of orphan vaccines: an industry perspective.

The development of vaccines against rare emerging infectious diseases is hampered by many disincentives. In the face of growing in-house expenditures associated with research and development projects in a complex legal and regulatory environment, most pharmaceutical companies prioritize their projects and streamline their product portfolio. Nevertheless, for humanitarian reasons, there is a need to develop niche vaccines for rare diseases not preventable or curable by other means. The U.S. Orphan Drug Act of 1983 and a similar proposal from the European Commission (currently under legislative approval) provide financial and practical incentives for the research and development of drugs to treat rare diseases. In addition, updated epidemiologic information from experts in the field of emerging diseases; increased disease awareness among health professionals, patients, and the general public; a list of priority vaccines; emergence of a dedicated organization with strong leadership; and the long-term pharmacoeconomic viability of orphan products will be key factors in overcoming the complexity of orphan status and the limited need for vaccine.

Drug Approval↗

Medical care of nursing home residents.

OBJECTIVE: To present an overview of the special challenges of providing medical care for nursing home residents. DESIGN: After researching the current medical literature, we summarized information on nursing home demographics, government regulations, and specific care issues for medical practice in nursing homes. RESULTS: Almost 2 million Americans currently live in more than 20,000 nursing homes nationwide, and these nursing home residents are increasingly older and more frail than in the past. Most nursing home residents receive multiple prescription medications, and many are cognitively and functionally impaired. Nursing home-acquired infections are a frequent occurrence, as are falls and fall-related injuries. Recent federal laws have had a major effect on medical care in the nursing home and have made physicians more accountable for the care provided. The use of physical restraints and psychotropic drugs has been severely restricted. CONCLUSION: The medical care of nursing home residents presents many challenges to primary-care physicians. Nevertheless, nursing home residents are among those patients in greatest need of competent, compassionate care. Despite numerous disincentives, provision of medical care for nursing home residents can be gratifying.

Accidental Falls↗

Infection control and the long-term care facility.

Approximately 70% of health care associated pathogens are resistant to one or more antibiotics. Experts maintain that most antimicrobial-resistant pathogens develop from antibiotic overuse and inappropriate antibiotic selection or treatment duration. Up to 70% of long-term care residents receive at least one course of an antimicrobial agent during a one-year period. Four types of infections occur most often among long-term care residents: urinary tract, respiratory tract, skin and soft tissue, and gastrointestinal tract, and outbreaks are common. Diagnostic uncertainty, failure to recognize fever's clinical manifestation in the elderly, treatment of asymptomatic bacteriuria, and bacterial colonization contribute to antibiotic overuse. Recent infection control guidelines recommend more targeted antibiotic utilization review. Recommendations are presented for implementing antibiotic utilization programs. Hand washing and other measures, such as droplet precautions, are discussed. Economic disincentives surrounding antimicrobial research are highlighted.

Cross Infection↗

Doctoral training of African scientists.

There are two principal rationales for doctoral training of African scientists in health: 1) these scientists are essential for the nations of sub-Saharan Africa to define and implement their own health priorities, and 2) the research they perform is essential for development. However, this training is difficult because of its expense (> $20,000 per year), because many developed country mentors are unaware of the realities of research in sub-Saharan Africa, and because major differences in salary provide a financial disincentive to return. We describe a training strategy that reduces attrition because it is linked to the investigators' responsibilities before and after training, and to home country priorities. This strategy requires a close relationship between the developing country (on-site) and developed country (off-site) mentors, with joint participation in the selection and funding process, followed by course work and short-term, independent projects off-site that lead to a thesis project in the developing country, and subsequently to a defined professional position in the developing country after completion of the doctoral degree. For this strategy to succeed, the developed country mentor must have both field experience and investigative expertise; the developing country mentor must have an understanding of modern biology, as well as clinical and epidemiologic experience. In addition, we would like to emphasize that the long-term retention of these talented, highly-trained individuals requires a similar long-term commitment by their developed country mentors, well beyond the short term of most research funding.

Africa South of the Sahara↗

Carrots and sticks: impact of an incentive/disincentive employee flexible credit benefit plan on health status and medical costs.

PURPOSE: Employee wellness programs aim to assist in controlling employer costs by improving the health status and fitness of employees, potentially increasing productivity, decreasing absenteeism, and reducing medical claims. Most such programs offer no disincentive for nonparticipation. We evaluated an incentive/disincentive program initiated by a large teaching hospital in western Michigan. METHODS: The HealthPlus Health Quotient program is an incentive/disincentive approach to health promotion. The employer's contribution to the cafeteria plan benefit package is adjusted based on results of an annual appraisal of serum cholesterol, blood pressure, tobacco use, body fat, physical fitness, motor vehicle safety, nutrition, and alcohol consumption. The adjustment (health quotient [HQ]) can range from -$25 to +$25 per pay period. We examined whether appraised health improved between 1993 and 1996 and whether the HQ predicted medical claims. RESULTS: Mean HQ increased slightly (+$0.47 per pay period in 1993 to +$0.89 per pay period in 1996). Individuals with HQs of less than -$10 per pay period incurred approximately twice the medical claims of the other groups (test for linear trend, p = .003). After adjustment, medical claims of employees in the worst category (HQ < -$10 per pay period) were $1078 (95% confidence interval $429-$1728) greater than those for the neutral (HQ between -$2 and +$2 per pay period) category. A decrease in HQ of at least $6 per pay period from 1993 to 1995 was associated with $956 (95% confidence interval $264-$1647) greater costs in 1996 than was a stable HQ. CONCLUSIONS: The HealthPlus Health Quotient program is starting to yield benefits. Most employees are impacted minimally, but savings are accruing to the employer from reductions in medical claims paid and in days lost to illness and disability.

Absenteeism↗

Low vision rehabilitation for a patient with a traumatic brain injury.

The client described in this article had undergone intensive rehabilitation for physical and cognitive deficits that resulted from an anoxic encephalopathy. Her recovery was good in all areas except visual functioning. Her reading and writing deficits were initially thought to result from visual-perceptual problems. A low vision evaluation identified the deficits as resulting from a macular visual field loss. Warren (1993) has proposed that an intact visual field is one of the basic components of vision that must be present before higher visual processing can occur. Until the macular perimetry was performed on this client, the extent of her central field loss was unknown, and the treatment that focused on the higher level visual processing was unsuccessful. The low vision program targeted the central field loss as the probable cause for her difficulties and an effective treatment protocol was established. The client was instructed regarding the nature of her visual field deficit and was trained in methods to compensate for this deficit. Although she has not returned to work as of this writing because of financial disincentives, the training resulted in a measurable and functional improvement in the client's ability to read continuous print text, a task she had not performed in 4 years, and in her ability to perform all writing tasks needed for daily living.

Adult↗

Hidden treasure: nurses writing for publication.

Nurses have a wealth of tacit and explicit knowledge, the value of which remains hidden because of a fear of authorship. How can nurses overcome their intimidation by the pen? In this paper, the personal and intrinsic are integrated with the public and literary as key issues on nurses' authorship are explored. Motivation and disincentives are balanced against helpful strategies for new writers such as cultivating a positive attitude, linking with a critical colleague, consulting 'how to' books, and journal keeping. In addition, originality, creativity, ethics and the shadow side of publishing are discussed.

Adaptation, Psychological↗

Health promotion and older people: a qualitative study of general practitioners' views.

OBJECTIVES: To explore general practitioners' (GPs') beliefs about health promotion for older people and attitudes towards educational strategies likely to improve practice in this area. DESIGN AND SETTING: Four discussion groups, each lasting one and a half hours, completed in Melbourne, Australia in August and September 1995. Interviews were transcribed verbatim and analysed for major themes. PARTICIPANTS: A convenience sample of 20 GPs took part; 11 university affiliates, four participant contacts and five GPs from telephone book listings. RESULTS: GPs' perceptions of their health promotion practice varied from "integrated into all medical care", to "something separate from usual practice". Positive views of older people contrasted with ageist views, with a few GPs expressing a nihilistic approach to medical care of older people. Regardless of the GPs' attitudes, lack of time and reimbursement disincentives were perceived to limit preventive practice and the potential impact of health promotion interventions. GPs felt overwhelmed with their workloads, and initial reactions to the idea of any "new" program were negative. Reactions to educational strategies varied, with choice and relevance to ease of practice being important for GP participation. CONCLUSIONS: GPs differ in their views of health promotion and in their approaches to its delivery for older people. Educational programs are often viewed negatively, but if they offer the opportunity to save time, increased participation may be more likely.

Aged↗

The inverse care law revisited: impact of disadvantaged location on accessing longer GP consultation times.

OBJECTIVE: To compare the rate of provision of longer consultations per head of population across practice locations categorised by socioeconomic status. DESIGN: Retrospective analysis of Medicare data for all consultations for all general practitioners in Australia for the 1998-99 and 1999-2000 financial years, grouped by postcode of practice location. Postcodes were categorised by the Socio-Economic Indexes for Areas, Index of Relative Socio-Economic Disadvantage score. MAIN OUTCOME MEASURES: Number of consultations and number of brief, standard, long and prolonged consultations per capita in each postcode grouping. RESULTS: The absolute number of long plus prolonged consultations showed no trend across postcode groups, but the rate ratio per person was significantly higher in more advantaged postcode areas. This represents an example of care provision in inverse relationship to need. DISCUSSION: Despite higher rates of chronic disease and lower rates of preventive care uptake, patients in low socioeconomic status areas receive longer GP consultations at a lower rate than patients in more advantaged areas. Possible strategies to overcome this inverse care provision include increased numbers of GPs in disadvantaged communities, removal of financial disincentives to longer consultations, and strengthening health promotion and community health services in disadvantaged areas.

Family Practice↗

General practitioner attitudes to case conferences: how can we increase participation and effectiveness?

OBJECTIVES: To identify general practitioners' views on the barriers to using case conferencing (as outlined in the Medical Benefits Schedule (MBS) Enhanced Primary Care package) and to develop a set of principles to encourage greater GP participation in case conferences. DESIGN: Qualitative study, involving semistructured questions administered to focus groups of GPs, conducted between April and July 2001 as part of a broader study of case coordination in palliative care. PARTICIPANTS: 29 GPs from urban, regional, and rural areas of Queensland. PRINCIPAL FINDINGS: Many of the GPs' work practices militated against participation in traditionally structured case conferences. GPs thought the range of MBS item numbers should be expanded to cover alternative methods of liaison (eg, phone consultations with other service providers). The onerous bureaucratic processes required to claim reimbursement were an additional disincentive. CONCLUSIONS: GPs would probably be more likely to participate in case conferences if they were initiated by specialist services and arranged more flexibly to suit GP work schedules.

Attitude of Health Personnel↗

Functional advantages of laparoscopic live-donor nephrectomy compared with conventional open-donor nephrectomy.

Live-donor kidney transplants accounted for only 27% of all kidney transplants performed in the United States in 1995. Prolonged hospitalization, pain, extended convalescence, and related socioeconomic concerns associated with traditional open-donor nephrectomy surgery may discourage potential donors, contributing to a low percentage of live kidney donors. To remove such disincentives, the laparoscopic live-donor nephrectomy procedure was introduced. In this study, the post-discharge course of 10 laparoscopic nephrectomy donors was compared with that of 27 open nephrectomy donors over the same time period. Laparoscopic nephrectomy donors experienced significantly shorter hospitalizations, less pain, felt able to return to work and normal routines sooner, and needed significantly less assistance during the recuperation period than did open nephrectomy donors. The laparoscopic nephrectomy procedure may decrease many of the concerns of potential donors, thus making live kidney donation more attractive and increasing the kidney supply.

Activities of Daily Living↗

Humanitarian service and recruitment and retention of uniformed services medical personnel.

A recent voluntary survey of 410 personnel from the U.S. Armed Forces Medical Departments and the Public Health Service indicated that humanitarian service experience has positive effects on recruitment and retention: 48% of respondents indicated that the opportunity to provide humanitarian service was a factor in their decision to join a uniformed service and 62% indicated that humanitarian service opportunities positively influenced their decision to remain in uniform. Humanitarian service requirements were a disincentive to remain in uniform for 25%. Pending further study, these preliminary implications can be applied to personnel policies and programs to recruit and retain uniformed health care professionals.

Altruism↗

Comparison of the quality of ambulatory care for fee-for-service and prepaid patients.

OBJECTIVE: To determine whether the quality of care for common ambulatory conditions is adversely affected when physicians are provided with incentives to limit the use of health services. DESIGN: Retrospective cohort study over a 2-year period. SETTING: Four group practices that cared for both fee-for-service patients and prepaid patients within a network model health maintenance organization (HMO). PATIENTS: Equal numbers of prepaid (HMO) and fee-for-service patients were selected by randomly choosing medical records from each group practice: 246 patients with chronic uncomplicated hypertension and 250 women without chronic diseases who received preventive care. MAIN OUTCOME MEASURES: Adequate hypertension control was defined as a mean blood pressure of less than 150/90. Adequate preventive care was defined as the provision of blood pressure screening, colon cancer screening, breast cancer screening, and cervical cancer screening within guidelines recommended by the 1989 U.S. Preventive Services Task Force. Resource use was measured by the annual number of visits and tests. MAIN RESULTS: The adjusted relative odds of HMO patients having controlled hypertension, compared with fee-for-service patients, were 1.82 (95% CI, 1.02 to 3.27). The relative risks of HMO patients receiving preventive care within established guidelines were 1.19 (CI, 0.93 to 1.51) for colon cancer screening, 1.78 (CI, 1.11 to 2.84) for annual breast examinations, 1.75 (CI, 1.08 to 2.84) for biannual mammography, and 1.35 (CI, 1.13 to 1.60) for Papanicolaou smears every 3 years. Prepaid patients had visit rates that were 18% to 22% higher than those of fee-for-service patients. CONCLUSIONS: In the type of network model HMO we studied, the quality and quantity of ambulatory care for HMO patients was equal to or better than that for fee-for-service patients. In this setting, the incentives for physicians to limit resource use may be offset by lack of disincentives for HMO patients to seek care.

Ambulatory Care↗

Internal medicine and the journey to medical generalism.

The overspecialized U.S. physician workforce and mix of graduating residents undermine strategies to provide quality and affordable health care to all Americans. Several respected advisory bodies have recently proposed fundamental changes in federal policy to better match physician supply and specialty mix with health care needs. They recommend that Congress limit the total number of filled first-year resident positions to 110% of the number of U.S. medical school graduates, a 20% reduction from current levels. They have proposed that positions and funding be allocated to medical schools, teaching hospitals, residency programs, or consortia of such entities to ensure that at least 50% of each graduating residency class enters generalist practice. An all-payer, graduate medical education pool and financing system have been suggested as ways to uncouple the physician workforce from hospital service needs and to eliminate disincentives toward ambulatory and primary care training. Increases in generalist production must be accompanied by decreases in nonprimary care specialty and subspecialty positions. In addition, generalist physicians must be better prepared in managed care competencies. Given today's subspecialist surplus, managed care organizations are considering how to retrain subspecialists as generalists. The Federated Council of Internal Medicine's goal that 50% of its graduates become general internists is an important step because internists compose one sixth of all physicians and one third of all first-year residents. This article identifies the challenges that lay ahead on the road to medical generalism and what it may take to get there.

Health Policy↗

Heterologous antisera and antivenins are essential biologicals: perspectives on a worldwide crisis.

Active immunization against infectious disease is important. However, much of our world faces poverty, social injustice, and warfare, all of which cause universal immunization to remain a distant dream. Agents that provide passive immunity thus remain essential biologicals. The most important of these are human or equine antisera against rabies, tetanus, diphtheria, and snake antivenins. Homologous products are either unavailable or unaffordable in places where they are needed the most. Less expensive heterologous (equine) antisera can be purified and are safe to use, but these antisera are also in short supply. Monoclonal antibodies have been developed but are even less likely to be affordable in poor countries. Several traditional sources of equine antisera are becoming depleted as a result of economic disincentives; a poor reputation based on the high adverse reaction rates of the old, unpurified products; and the activities of animal rights activists who object to the use of horses as blood donors. Purified, pepsin-digested equine antisera are preferred; but developing countries sometimes are forced to make crude products that are less safe or have no specific therapy available at all.

Antivenins↗

Does pay-for-performance improve the quality of health care?

BACKGROUND: Most physicians and hospitals are paid the same regardless of the quality of the health care they provide. This produces no financial incentives and, in some cases, produces disincentives for quality. Increasing numbers of programs link payment to performance. PURPOSE: To systematically review studies assessing the effect of explicit financial incentives for improved performance on measures of health care quality. DATA SOURCES: PubMed search of English-language literature (1 January 1980 to 14 November 2005), and reference lists of retrieved articles. STUDY SELECTION: Empirical studies of the relationship between explicit financial incentives designed to improve health care quality and a quantitative measure of health care quality. DATA EXTRACTION: The authors categorized studies according to the level of the incentive (individual physician, provider group, or health care payment system) and the type of quality measure rewarded. DATA SYNTHESIS: Thirteen of 17 studies examined process-of-care quality measures, most of which were for preventive services. Five of the 6 studies of physician-level financial incentives and 7 of the 9 studies of provider group-level financial incentives found partial or positive effects on measures of quality. One of the 2 studies of incentives at the payment-system level found a positive effect on access to care, and 1 showed evidence of a negative effect on access to care for the sickest patients. In all, 4 studies suggested unintended effects of incentives. The authors found no studies examining the optimal duration of financial incentives for quality or the persistence of their effects after termination. Only 1 study addressed cost-effectiveness. LIMITATIONS: Few empirical studies of explicit financial incentives for quality were available for review. CONCLUSIONS: Ongoing monitoring of incentive programs is critical to determine the effectiveness of financial incentives and their possible unintended effects on quality of care. Further research is needed to guide implementation of financial incentives and to assess their cost-effectiveness.

Insurance, Health↗

Psychiatrists and community mental health: normative versus utilitarian incentives.

The inability to attract adequate numbers of psychiatrists has been a concern of community mental health (CMH) planners for some time. This paper considers whether normative or utilitarian (i.e., economic) inducements have more of an impact on their participation. Data are drawn from a survey of 946 New York area psychiatrists. These data suggest the likelihood of incremental growth among community psychiatrists because organizational involvement, high quality residency training, and "younger generation" status all are linked to normative commitments to CMH values. Moreover, since political orientation is the strongest single determinant of these values, commitments also can be deliberately stimulated through normative appeals. Yet, our principal finding is that severe utilitarian disincentives tend to undercut the effects of normative inducements and commitments. The paper concludes by examining the social policy implications for community mental health staffing of the primacy of utilitarian considerations among psychiatrists.

Adolescent Psychiatry↗

The last third. R&D: the return on our investment.

"The challenge is to balance what is good for the individual against what is in society's best interests without providing disincentives for product development." This quotation from a 1988 JAMA article by Peter Jacobson and John Rosenquist exploring contrast media issues goes beyond the usual scope of concern and also crystallizes why the low osmolar contrast agent (LOCA) controversy is so typical of the dilemmas that healthcare and society as a whole will continue to confront. The first two-thirds of this quotation presents a challenge that has been the subject of the LOCA debate for some time now: how to weigh the benefit to the individual versus the cost to society. The last third of this challenge acknowledges the importance of research and development, which has been largely ignored although it represents a vital ingredient for future healthcare improvements.

Contrast Media↗