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Medicare Part D: an overview of its practical and clinical impact.

The Medicare Part D outpatient prescription drug benefit will transform American health care delivery. In addition to increasing access to medicines, it will have a profound impact on physicians and drug developers. Senior citizens and other Medicare recipients will be forced to come to terms with a complex benefit structure and to make difficult choices. Physicians will have to help their patients navigate the new benefit as well as adjust their practices to deal with multiple formularies with different coverage policies. Medicare is creating a framework for collecting evidence, both from studies of comparative efficacy of drugs and from automated tracking of outcomes.

Aged↗

Removal of life support in intensive care units.

Advancements in techniques of medical technology have made it possible to postpone death, which, in many situations, amounts to nothing more than a protracted process of dying rather than a prolonging of life. This, together with the fact that these techniques are prohibitively expensive has brought to the fore difficult and extremely uncomfortable problems in medical ethics, especially with regard to who should have and who should not have high technology medical treatment. The principles of autonomy and informed consent, in the context of a shared resource such as intensive care, are particularly thorny issues. Normally it is imperative that individuals make their own autonomous decisions in respect of medical treatment but there are times when consent is of secondary importance and when autonomy must of necessity be limited. However, information concerning medical decisions in intensive care should always be freely available to patients and their surrogates.

Blood Transfusion↗

Quality Enhancement Research Initiative for human immunodeficiency virus/acquired immunodeficiency syndrome: framework and plan. HIV-QUERI Executive Committee.

The Veterans Health Administration (VHA) sees approximately equal to 17,000 human immunodeficiency virus (HIV)-infected patients each year, which makes it the largest provider of HIV care in the United States. HIV causes chronic progressive disease that leads to early death. Newer combination antiretro viral treatments are effective but expensive and difficult to use. The HIV Quality Enhancement Research Initiative (HIV-QUERI) uses the QUERI process to identify high-risk and high-volume populations (step 1), which includes those already under VHA care for HIV, those who do not know of their infection, and those at risk for HIV. In identifying best practices (step 2), the HIV-QUERI will benefit greatly from existing guidelines for the care of established HIV infection, but gaps in knowledge regarding adherence to medication regimens and cost-effective screening are large. To identify existing practice patterns (step 3), the HIV-QUERI will develop a clean analytic data set based on Immunology Case Registry files and expand it through a survey of veterans. Interventions to improve care (step 4) will include national, regional, and site-specific feedback on performance relative to quality standards, as well as patient-level and provider-level interventions to improve adherence and support medical decision-making. To document that best practices improve outcomes and quality of life (steps 5 and 6), HIV-QUERI will track indicators on an ongoing basis by use of the Immunology Case Registry database and possible future waves of the survey. In addition, we will require that these issues be addressed in evaluations of HIV-QUERI interventions. In the present article, we present these steps within a framework and plan.

Benchmarking↗

Doctors as managers: poachers turned gamekeepers?

Doctors in health care systems of different types are coming under increasing pressure to take on active roles in management. Mounting concern among governments over the escalating costs of health care, coupled with a desire to improve the quality of care and render services more responsive to user preferences has resulted in management being viewed as offering an effective means of tackling these issues. Until recently, the favoured strategy was to strengthen management in order to curb doctors' discretionary decision-making. There is now a shift towards creating managers out of doctors with all that this implies for the future shape of health services. There are also issues about the training and development required for a management role, the stratification of roles within the medical profession, and the future status of lay, or non-medical managers. The paper reviews the debate about doctors and managers and their distinctive value bases. It suggests that doctors can be involved in management as managers at two levels--meso and micro--and considers the issues raised at each level. The paper presents an analysis of the wider context in which the debate about doctors as managers is taking place. The main thesis put forward is that far from managers incorporating doctors, the end result may prove to be the other way round with 'provider capture' of the management agenda in health services a distinct possibility. In contrast to managers, doctors retain enormous public respect and support. As long as it is so doctors will remain powerful stakeholders in defining and controlling the shape and range of health services available. Their active involvement in management could lead to a strengthening of their position. It is argued that, paradoxically, this could make it more difficult for governments to challenge doctors' work practices. Medicine's traditional preoccupations and its resilience to change are likely to remain as strong as ever thereby disappointing advocates of a health and social care system located in a broader policy framework which emphasises health gain and a holistic approach to health.

Attitude of Health Personnel↗

Patients without choices: the ethics of decision-making in emergency medicine.

Patients who use emergency department services generally have no choice of facilities or medical personnel. This fact affects the nature of the physician-patient relationship and the moral rules that govern it. Because a long-term relationship has not been developed, a more formal, legalistic relationship seems inevitable and appropriate. Moreover, the emotional stress of the emergency situation on the patient and the fact that the baseline mental status is unknown to the medical personnel often make it difficult to determine competency for decision-making, especially in cases of refusal of treatment. Although standards of informed consent apply in emergency care, there seem to be discrepancies between theory and practice, and emergency physicians may be more guilty than others of unjustified paternalism. Ways must be found to ensure patients the greatest degree possible of autonomy and informed consent analogous to what they would have in a nonemergency doctor-patient relationship.

Decision Making↗

[Attitudes towards treatment of extremely premature infants in Norwegian obstetric and pediatric departments].

The aim of this questionnaire survey was to investigate whether Norwegian hospitals have guidelines for lifesaving treatment in cases of extreme prematurity and severe morbidity. 66 out of 71 doctors in charge of Norwegian obstetric and paediatric units answered our questionnaire. 79% of the units had guidelines for starting medical treatment, 45% for ending treatment. Gestational age and the infant's vitality were the most important criteria in decisions concerning withholding of treatment. Two out of three units (44) had a lower gestational age limit, varying from 23 to 25 weeks; 41 of these 44 units used 23 or 24 weeks as the lower limit. Disability risk and the infants' suffering were the most important criteria for termination of treatment. One in five respondents attached little or no emphasis on the infants' suffering. Half of the respondents reported that they felt that making life or death decisions for premature infants had become more difficult over the last few years. Unrealistic expectations and pressure from the media and from parents were important reasons for this. We conclude equality of treatment for premature infants calls for an examination of all factors, medical and psychosocial, with a bearing on decisions.

Attitude of Health Personnel↗

Nursing home care.

The intent of this review is to highlight several difficult questions from a personal perspective while caring for debilitated elderly patients in a nursing home. These problems appear to be encountered less frequently in the acute-care setting. Where possible, supporting literature is cited and legal precedent is indicated. The following topics, among others, are discussed: a framework for physicians' ethical decisions, basic ethical principles, typical problems encountered by the physician, and considerations for withholding treatment.

Aged↗

The emergence of a culture that promotes evidence based clinical decision making within an acute care setting.

Nursing research programs within acute care hospitals are essential to the development and integration of nursing knowledge, difficult to implement and rarely evaluated. The purpose of this paper is three fold: (1) to describe the development, structures, and processes of a nursing research program within an acute care teaching hospital and (2) to describe selected evaluation outcomes and (3) to discuss future directions.

Decision Making↗

Priority setting in developing countries health care institutions: the case of a Ugandan hospital.

BACKGROUND: Because the demand for health services outstrips the available resources, priority setting is one of the most difficult issues faced by health policy makers, particularly those in developing countries. However, there is lack of literature that describes and evaluates priority setting in these contexts. The objective of this paper is to describe priority setting in a teaching hospital in Uganda and evaluate the description against an ethical framework for fair priority setting processes--Accountability for Reasonableness. METHODS: A case study in a 1,500 bed national referral hospital receiving 1,320 out patients per day and an average budget of 13.5 million US dollars per year. We reviewed documents and carried out 70 in-depth interviews (14 health planners, 40 doctors, and 16 nurses working at the hospital). Interviews were recorded and transcribed. Data analysis employed the modified thematic approach to describe priority setting, and the description was evaluated using the four conditions of Accountability for Reasonableness: relevance, publicity, revisions and enforcement. RESULTS: Senior managers, guided by the hospital strategic plan make the hospital budget allocation decisions. Frontline practitioners expressed lack of knowledge of the process. RELEVANCE: Priority is given according to a cluster of factors including need, emergencies and patient volume. However, surgical departments and departments whose leaders "make a lot of noise" are also prioritized. Publicity: Decisions, but not reasons, are publicized through general meetings and circulars, but this information does not always reach the frontline practitioners. Publicity to the general public was through ad hoc radio programs and to patients who directly ask. Revisions: There were no formal mechanisms for challenging the reasoning. Enforcement: There were no mechanisms to ensure adherence to the four conditions of a fair process. CONCLUSION: Priority setting decisions at this hospital do not satisfy the conditions of fairness. To improve, the hospital should: (i) engage frontline practitioners, (ii) publicize the reasons for decisions both within the hospital and to the general public, and (iii) develop formal mechanisms for challenging the reasoning. In addition, capacity strengthening is required for senior managers who must accept responsibility for ensuring that the above three conditions are met.

Decision Making, Organizational↗

[Bioethics, deontology, and law in neonatal intensive care].

Neonatal intensive care has greatly improved the survival chances but, at the same time, it has also given rise to serious ethical problems. Different contexts influence both physicians attitude and end-of-life practices in neonatology. The clinicians can not ever follow the principles of bioethics, as they are sometimes in conflict. Also, the strategies or guidelines proposed as approaches to neonatal decision-making are difficult to practise. Probably a neonatologist makes his decision even on the basis of his interior conviction and it is well known that in Italy the debate on bioethics is the subject of confrontation between Roman Catholic and secular viewpoint, expressing two positions: the so-called sanctity and the quality of life. However, a clinician has also an obligation to follow the Code of Professional Medical Ethics which cautions against therapeutic aggressiveness; but this document has not legal status. In addition, Italian law is strongly protective of infant life and any discrimination on the basis of malformation or poor prognosis violates constitutional law; moreover, the resuscitation of a preterm infant is mandatory even when the birth is the result of induced late abortion. The author concludes emphasizing the importance, in decision making, of accepting difference as opposed to the logic of the absoluteness of normality, because many handicaps may be accepted and a society expresses its moral richness also by the solidarity reserved to its weakest sons.

Bioethics↗

[Factors that influence home return from health care facilities for the elderly--related to the attitude of family caregivers].

AIM: The number of users of long-term care insurance has been increasing rapidly since it started in 2000. The number of those who want to enter the long-term care insurance facilities has increased. Although the basic philosophy of long-term care insurance is independence support and self-decision, to enter a facility or home return from facilities is likely to be decided by family caregivers, not by the elderly themselves. Moreover, the number of elderly who return home from welfare facilities is decreasing. We investigated the intension of caregivers who are willing to accept the institutionalized elderly at home and analyzed the factors affecting the acceptance of caregivers. METHODS: Subjects were elderly who were in long-term care insurance facility in June 2004, and their caregivers. The study was conducted between June 2004 and September 2004 in Ibaraki Prefecture in Japan. A face-to-face interview based on a questionnaire was conducted for the institutionalized elderly and by the mail for the caregivers. RESULTS: The caregivers of 34.6% of the elderly who hoped to return home intended to accept them home. There were differences between the plans of the elderly and caregivers. The risk factors (OR, 95% CI) to make the intention of the caregivers to accept the institutionalized elderly home difficult were level of cooperation with other family members to take care of elderly (OR 15.37, 2.05-115.24), dementia behavior disturbance category with more than one (OR 8.34, 1.02-68.05), time spending in bed of a day (OR 1.31, 1.01-1.71), few knowledge of long-term care insurance system of caregivers (OR 3.65,0.81-16.38). CONCLUSION: It has been suggested that more physical activities in the facility, establishment of a care-system for the demented elderly living in the community and an educational campaign by the long-term care insurance system are necessary to increase the willingness of caregivers to accept home return of institutionalized elderly.

Activities of Daily Living↗

Referral and screening for substance abuse treatment in jails.

As jails and prisons have become filled to capacity with inmates arrested and convicted for drug-related offenses, efforts have intensified to reduce subsequent drug use, drug-related crime, and recidivism among this population. Faced with the drug abuse epidemic; treatment resources in the community have expanded more quickly than in detention and corrections facilities. Many large jails and prisons do not presently have a substance abuse treatment program despite clear evidence of widespread drug and alcohol dependence problems among inmate populations. Where substance abuse treatment resources are available, administrators face difficult choices in determining which inmates will receive services. This paper provides a discussion of issues related to referral and screening procedures for in-jail substance abuse treatment programs. Referral and screening systems implemented in several jails across the country are reviewed.

Attitude to Health↗

[Costs and cost analysis].

The costs of an activity is frequently the most conspicuous part in decision making when changes in health care services are considered. It is thus essential to be aware of the principles and considerations underlying the composition of costs. The concept of cost is not restricted to expenditures that have to be paid. It involves the notion of opportunity cost i.e. the cost of a service is the satisfaction or benefit foregone in not being able to use the resources involved to obtain some other service which is also desirable and therefore also provides satisfaction. Strictly, this relates to the best alternative way of using the resources. In order to estimate the costs of an activity, all costs, whether direct or indirect, tangible or intangible, ought to be taken into account. The fact that they may be difficult to measure a value is no excuse for ignoring them. In a cost analysis the result has to be assessed in the light of the types of costs employed and the aim of the analysis. Average cost is very often used, but is seldom the relevant costs. What is normally of concern is the cost of some change. Only by using marginal costs i.e. those costs that actually do change is it possible to obtain a true picture of resource consequences of that change. Regardless of the type of cost it is necessary to consider on whom the costs fall and to whom the benefits accrue. These may not be the same.

Costs and Cost Analysis↗

The great escape? Prospects for regulating access to technology through health technology assessment.

OBJECTIVE: Health technology assessment (HTA) can be used both to promote access to safe, efficacious, and cost-effective technologies, and to discourage access to undesirable ones. Yet HTA has had less success than might be hoped in pursuing the latter goal. This paper examines the scope of HTA as currently practiced to contribute to regulation of access to undesirable technologies. DESIGN: The study design is a critical analysis of HTA's methods, based on an exposition of the normative issues involved in restriction of access to health technologies. The paper classifies technologies that might figure as potential candidates for exclusion into five categories and underscores the key social and ethical dilemmas associated with limiting their use. RESULTS: For four of the five categories of technology outlined, limitation of access necessarily involves denial of benefit. Limitation of access thus inevitably raises difficult normative issues. We show that these are ill-addressed by the range of "evidence" typically considered in technology assessments, which centers predominantly on clinical and technical features such as efficacy, safety, and costs. CONCLUSIONS: If HTA is to enhance our ability to make reasonable decisions concerning the use and diffusion of health technologies, it must better integrate consideration of the social, political, and ethical dimensions of health technologies into the process of technology assessment. We suggest a framework within which to approach this goal.

Canada↗

Practice guidelines and parental ADHD treatment evaluations: friends or foes?

In this exploratory descriptive study, we used focus groups to examine parental evaluations of treatment approaches to attention-deficit/hyperactivity disorder (ADHD) and the congruence of these evaluations with professional practice guidelines. We paid particular attention to home-care strategies and to parental experiences and attitudes regarding medications for ADHD. Some home-care techniques were consistent with evidence-based behavioral principles, whereas others seemed to be based on popular myths, with little indication that they could improve the child's behavior. Indeed, some might actually add unnecessary stress to the parent-child relationship by introducing ineffective limitations (e.g., dietary restrictions). Parental accounts uniformly depicted stimulant use, the cornerstone of ADHD treatment in the United States, as a difficult treatment modality to consider and accept for their children. Study findings indicate that professional guidelines and parent ADHD treatment evaluations are only partially congruent, with the greatest discrepancy in the role assigned to stimulants. Increased provider-parent communication concerning medications might improve adherence and treatment outcomes.

Attention Deficit Disorder with Hyperactivity↗

Therapist-driven protocols in adult intensive care unit patients.

TDPs occasionally are used to standardize or control respiratory management of the critically ill. Weaning protocols are most common. Little objective evaluation of the effects of TDPs in the critically ill has been published. Most protocols have been developed to improve efficiency of respiratory care staff and reduce unnecessary treatments in non-ICU patients. The most important reason for using TDPs in the ICU is to improve consistency of care. Reduction of variation between individual therapist style improves physicians' trust in the respiratory care department. Improved consistency may allow novel ICU therapies to be evaluated objectively. In general, TDPs are not directly transportable from one area or institution to another. TDPs require local development, and all interested parties must be part of the development process for success. The process of creating TDPs provides a forum for physicians, nurses, and therapists to establish mutual respect and understanding. The analytic approach needed to create useful TDPs provides a critical evaluation of unit procedures and promotes changes in care delivery extending outside the TDP. The complexity of disease process and patient care in the ICU makes comprehensive TDPs difficult to establish; however, use of computers for decision support can overcome the limitations of paper flow charts. Even without comprehensive TDPs, the development process is important to improving and understanding care of the critically ill. The effects of TDPs on ICU patient outcome are unknown currently. Benefits are possible and improved collaboration, better respiratory care staff morale, consistency of approach to care, and critical approach to clinical decision making can be gained by attempting to develop TDPs for respiratory care delivery in the ICU.

Adult↗

Fetuses with neural tube defects: ethical approaches and the role of health care professionals in Turkish health care institutions.

Neural tube defects (NTDs) are very serious malformations for the fetus, causing either low life expectancy or a chance of survival only with costly and difficult surgical interventions. In western countries the average prevalence is 1/1000-2000 and in Turkey it is 4/1000. The aim of the study was to characterize ethical approaches at institutional level to the fetus with an NTD and the mother, and the role of health care professionals in four major centers in Turkey. The authors chose perinatology units of four university hospitals and prepared questionnaires for the responsible professionals concerning their own and their institution's ethical approaches to the fetus with an NTD and the mother. The investigation revealed that there were no institutional ethical frameworks or ethics committees available to professional teams in the units. The roles of the health care professionals and their individual decisions and approaches based on ethical principles are described. The ethical decision-making process concerning fetuses with NTDs, examples of institutional approaches to the topic and institutional frameworks, and the role of nurses and other health care professionals are all discussed, based on a literature review. The authors suggest that institutional ethical frameworks, ethics committees, professionals' ethics education and multidisciplinary teamwork should be established for critical situations such as fetuses with an NTD.

Decision Making↗

Can hospital relocations and closures be stopped through the legal system?

The recent history of litigation to stop hospital closings in or relocations from minority communities is reviewed. Legal arguments and facts raised by plaintiffs and defendants in seven cases are summarized in the context of civil rights and health planning legislation. The results of the litigation are mixed. One hospital was denied permission to close, but this was decided principally on procedural grounds. A planning agency's recommendation against closing another hospital may prove difficult to implement for financial reasons. Several cases have resulted in modifications of relocation plans and have established guarantees of certain rights to plaintiffs. These, however, may be difficult to enforce if hospitals lack the desire or resources to sustain needed levels of service. Generally, the courts have been reluctant to undertake socioeconomic decision making. They have tended to excuse relocations with racially discriminatory impacts when it has been argued that the relocations were necessary for hospital financial survival, and they have been unwilling to test the credibility of those arguments. Legal avenues to contesting with success the closing of most hospitals also appear to be blocked by similar untested contentions.

Civil Rights↗