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Clinical trials in late life: new science in old paradigms.

This article, based on a Lawton Award Lecture, addresses the subject of the need to enhance the evidence base in our field in order to influence processes of policy development. Four issues are identified as critical to this: theory-driven targets of public health significance, use of appropriate and sophisticated approaches to research design and statistical modeling, development of instruments and measures, and conclusions that make a difference. Incentives are discussed with particular attention to regulatory approaches. A broad view of research is taken, with examples from studies of Alzheimer's disease and depression in late life. I conclude that new approaches to methodology will enhance our capacity to translate exciting new findings from the basic sciences into the development of therapeutics and that this will, in turn, enhance our capacity to inform the development of public policy.

Aged↗

Dynamics of the nutrition transition toward the animal foods sector in China and its implications: a worried perspective.

Many changes in diet and in physical activity are occurring simultaneously in the developing world. These diet shifts include large increases in energy density, in the proportion of the population consuming a high fat diet and in animal product intake. Animal source foods (ASF) play a major role in these diet shifts. This article documents the large shifts in the composition of diets and obesity across the developing world and notes that these changes are accelerating. Using China as a case study, evidence of the speeding up of this process is presented in descriptive and more rigorous dynamic longitudinal analysis. The implications of these changes for dietary and obesity patterns and cardiovascular disease are great. Indeed, developing countries are at a point where the prevalence of obesity is greater than that of undernutrition and concerns related to intake of saturated fat and energy imbalance must be considered more seriously by the agriculture sector. Current agriculture development policy in many developing countries focuses on livestock promotion and does not consider the potential adverse health consequences of this strategy. Although linkages between ASF intake and obesity cannot be established as clearly as they are for high ASF intakes, heart disease and cancer, the potential adverse health effects linked with an increased ASF intake should no longer be ignored.

Adult↗

First steps towards evaluating clinical supervision in nursing and health visiting. I. Theory, policy and practice development. A review.

The subject of clinical supervision for nurses and health visitors in the UK is considered in this paper. The paper highlights recent debates in thinking and rapid developments in practice. The original concept of clinical supervision, its theoretical propositions and development, recent policy influences and current strategies for evaluation are debated.

Community Health Nursing↗

Transfer of Health for All policy - What, how and in which direction? A two-case study.

BACKGROUND: This article explores the transfer of World Health Organization's (WHO) policy initiative Health for All by the Year 2000 (HFA2000) into national contexts by using the changes in the public health policies of Finland and Portugal from the 1970's onward and the relationship of these changes to WHO policy development as test cases. Finland and Portugal were chosen to be compared as they represent different welfare state types and as the paradigmatic transition from the old to new public health is assumed to be related to the wider welfare state development. METHODS: The policy transfer approach is used as a conceptual tool to analyze the possible policy changes related to the adaptation of HFA into the national context. To be able to analyze not only the content but also the contextual conditions of policy transfer Kingdon's analytical framework of policy analysis is applied. CONCLUSIONS: Our analysis suggests that no significant change of health promotion policy resulted from the launch of HFA program neither in Finland nor in Portugal. Instead the changes that occurred in both countries were of incremental nature, in accordance with the earlier policy choices, and the adaptation of HFA program was mainly applied to the areas where there were national traditions.

Journal Article↗

Ethics committees: is there a role for them in the laboratory?

Ethics committees are commonly found in United States health-care institutions. As multidisciplinary committees within the medical staff structure, they are active in education, policy development, and case consultation. Clinical pathology laboratories face a number of ethically sensitive issues, including the confidentiality of sensitive data, problems of patient-caregiver or caregiver-patient transfer of the human immunodeficiency virus (HIV), and conflicts about allocating scarce resources such as blood. Ethics committees can be an important resource to clinical laboratorians seeking to develop ethically defensible policies and procedures.

Acquired Immunodeficiency Syndrome↗

Protecting subjects, preserving trust, promoting progress I: policy and guidelines for the oversight of individual financial interests in human subjects research.

In December 2001, the AAMC Task Force on Financial Conflicts of Interest in Clinical Research released this report, the first of two (both published in this issue of Academic Medicine). This report focuses on gaps in existing federal financial disclosure regulations of individual conflicts of interests, finding that additional scrutiny is recommended in two areas: human subjects research and privately sponsored research. The task force suggests that when potential conflicts exist, a conflicts of interest committee should apply a rebuttable presumption against engaging in human subjects research. The task force recommends that the circumstances giving rise to the presumption against the proposed activity be balanced against compelling circumstances in favor of the conduct of the research. The AAMC task force delineates core principles to guide institutional policy development. First, an institution should regard all significant financial interests in human subjects research as requiring close scrutiny. Second, in the event of compelling circumstances, an individual holding a significant financial interest may be permitted to conduct the research. Whether circumstances are deemed compelling will depend in each case upon the nature of the science, the nature of the interest, how closely the interest is related to the research, and the degree to which the interest may be affected by the research. Four other core principles for development of institutional policies are identified in the report, pertaining to reporting, monitoring, management of conflicts, and accountability.

Clinical Trials as Topic↗

[Implications of the diffusion of the International Classification of Handicaps on policies concerning handicapped persons].

The International Classification of Impairments, Disabilities and Handicaps (ICIDH) has had a considerable impact on perception of the consequences of disease, and of the modifications which these consequences can present. Ideally, ICIDH is at the same time a descriptive, an explanatory and an implementation too for health policy. Two examples of the conceptual and policy use of ICIDH are given: policy developments proposed to Member States of the Council of Europe; multisectoral development in Québec. Both these examples underline that the ICIDH not only deals with clarifying items, but is also a support to the development of responsible policies.

Persons with Disabilities↗

Barriers to cancer treatment: a review of published research.

PURPOSE/OBJECTIVES: To review published research on barriers to cancer treatment to provide a foundation for subsequent research and program and policy development directed at diminishing these barriers. DATA SOURCES: Relevant literature from medical and behavioral science data bases published between 1964 and 1994. Researchers reviewed 752 abstracts; they identified 160 articles that related directly to research on barriers to cancer treatment. Of these 160 articles, researchers chose 61 for a subsequent review using criteria to evaluate the strength of the study design and sampling procedures. DATA SYNTHESIS: The major barriers consistently documented to influence whether or not patients with cancer sought or continued treatment included communication problems between patients and providers, lack of information on side effects, cost of treatment, difficulties in obtaining and maintaining insurance coverage, and absence of social support networks. Access barriers generally were greater for older women, members of minority groups, and patients of lower socioeconomic status. The vast majority of the studies were conceptual or descriptive in nature and were based on nonprobability clinic-based samples. CONCLUSIONS: The limitations of existing research point to the need for studies on barriers to cancer treatment based on analytic population-based study designs that examine the relative importance of factors derived from multivariate explanatory models. This information may be used to develop programs and policies to ameliorate treatment barriers for patients with cancer. IMPLICATIONS FOR NURSING PRACTICE: The research priorities set forth by the Oncology Nursing Society also indicate a need for this type of research because quality of life, cost containment, and outcomes assessment all are directly or indirectly affected by the timely diagnosis of cancer. Treatment barriers have the potential to significantly affect an individual's ability to seek care and ultimately to increase the cost of care associated with adverse outcomes that may result from delays in seeking treatment.

Female↗

Rural health network development: public policy issues and state initiatives.

Rural health networks are a potential way for rural health care systems to improve access to care, reduce costs, and enhance quality of care. Networks provide a means for rural providers to contract with managed care organizations, develop their own managed care entities, share resources, and structure practice opportunities to support recruitment and retention of rural physicians and other health care professionals. The results of early network development initiatives indicate a need for state officials and others interested in encouraging network development to agree on common rural health network definitions, to identify clearly the goals of network development programs, and to document and analyze program outcomes. Future network development efforts need to be much more comprehensive if they are to have a significant impact on rural health care. This article analyzes public policy issues related to integrated rural health network development, discusses current efforts to encourage network development in rural areas, and suggests actions that states may take if they desire to support rural health network development. These actions include adopting a formal rural health network definition, providing networks with alternatives to certain regulatory requirements, and providing incentives such as matching grants, loans, or technical assistance. Without public sector support for networks, managed care options may continue to be unavailable in many less densely populated rural areas of the country, and locally controlled rural health networks are unlikely to develop as an alternative to the dominant pattern of managed care expansion by large urban entities. Implementation of Medicare reform legislation could provide significant incentives for the development of rural health networks, depending on the reimbursement provisions, financial solvency standards, and antitrust exemptions for provider-sponsored networks in the final legislation and federal regulations.

Antitrust Laws↗

Involvement of pharmacy faculty in the development of policies for pharmaceutical sales representatives.

BACKGROUND: Few studies evaluating the impact of the pharmaceutical industry on postgraduate medical education have been done. Recently, position statements and professional guidelines have emerged to ensure the integrity of physician-industry relationships in the areas of clinical judgement, research, and medical education. METHODS: The present study surveyed directors of family practice residency programs in the United States to define the level of pharmacotherapy curriculum development and the existence of policies for pharmaceutical sales representatives. RESULTS: Of the 383 directors, 325 (85%) responded to a mailed survey. Nearly one third (32%) of the responding programs had pharmacist faculty, the majority of whom held a doctor of pharmacy degree. Approximately 30% of programs reported that they had printed guidelines for pharmaceutical sales representatives. CONCLUSIONS: Programs with pharmacist faculty are more likely to have a well-developed pharmacotherapy curriculum and printed guidelines for pharmaceutical sales representatives.

Curriculum↗

Emergency contraception for sexual assault victims: an advocacy coalition framework.

A bill was introduced into the Tennessee legislature in the 2005 session that would require emergency departments to offer and dispense emergency contraception to sexual assault survivors who are at risk of pregnancy. Several advocacy groups collaborated to form the Women's Health Safety Network for the purpose of communicating as one voice. The advocacy coalition framework of policy development is applied to the political system and is used as a model to discuss issues impacting policy development for this particular bill. Key actors, proponents, and opponents to this bill are presented along with constraints to policy acceptance. The challenge for emergency contraception advocates on a state and national level is to keep the focus on public health science, the health and well-being of women, and out of the abortion debate.

Catholicism↗

The impact of health policy on chiropractic.

OBJECTIVE: The chiropractic profession has traditionally had little or no direct influence on health policy. Conversely, every chiropractor is impacted daily by health policy decisions promulgated by government agencies, health purchasers, managed care organizations and others. This discussion provides an overview of health policy constituencies important to chiropractors, reviews processes currently being used to assess health care technology and develop policy and offers strategies for the profession to more actively engage in constructive policy development. METHOD: Descriptive overview of key issues based on qualitative selective overview of literature and author's observations based on two years employment in a government health policy position. CONCLUSIONS: The chiropractic profession's traditional approach to influencing health policy has focused on public relations, political lobbying for favorable legislation and litigation, which has increased public awareness and resulted in a number of legislative successes. However, for the most part, the momentum of decision-making at agency levels and in policy staff positions continues to occur without involvement of chiropractors trained or experienced in policy-making. This is in contrast with medicine and other allied health fields, whose ranks hold such positions routinely. Additionally, methodology for policy decision-making is increasingly evidence-based. Strategies for the chiropractic profession to more actively participate in this arena are offered.

Chiropractic↗

Development and localisation of casemix applications for inpatient hospital activity in EU member states.

The successful infiltration of casemix techniques across geographical, systemic and cultural boundaries provides an interesting and timely example of the translation of research evidence into health policy development. This paper explores the specifics of this policy development by reviewing the application of casemix techniques within the acute hospital systems of European Union member states. The fact that experimentation with or application of casemix measures can be reported for the majority of European Union member states would suggest that the deployment of these measures can be expected to continue to expand within these health systems into the new millennium.

Acute Disease↗

The key to the boardroom door: policies for volunteer programs.

Writing and updating policies for volunteer programs is a key strategy to gain the attention and recognition of board and senior administrators for volunteer programs and for managers of volunteers. Further, in light of the recent and rapid growth in volunteering and in the complexity of volunteer work itself, policy development has become an indispensable element in risk management and liability reduction. Managers of volunteers are encouraged to involve their boards and CEOs in policy development. Building the framework of beliefs, values, and rules through policies will ensure both safe and satisfying involvement for the volunteer, and effective service for the client.

Governing Board↗

Policies on medical decisions concerning the end of life in Dutch health care institutions.

OBJECTIVE: To describe the prevalence and some features of policies on medical decisions concerning the end of life (MDELs) in Dutch hospitals, nursing homes, and institutions for the mentally disabled. DESIGN: A cross-sectional descriptive postal survey of 558 Dutch health care institutions. SETTING: All Dutch hospitals, nursing homes, and general institutions for the mentally disabled. PARTICIPANTS: Directors of patients care of the institutions. MAIN OUTCOME MEASURES: Respondents' reports on the existence of policies and guidelines on the following MDELs: euthanasia/assisted suicide (EAS), life-terminating acts without explicit request of the patient, refusal of treatment by patient, withholding or withdrawing treatment, symptom and pain control, and do-not-resuscitate (DNR) decisions. RESULTS: Of 558 health care institution managers, 86% responded. Most of the hospitals (69.2%) and nursing homes (73.9%) but only 16.3% of the institutions for the disabled had a written EAS policy. Nursing homes with a ban on EAS often had religious affiliations. In 37% of nursing homes, 15% of hospitals, and 15% of institutions for the disabled, the management had written policies on terminating life without request. Sixty percent of the hospitals, 35% of the nursing homes, and 17% of the institutions for the disabled had guidelines for one or more of four other distinct MDELs. Forty-five percent, 20%, and 8% of hospitals, nursing homes, and institutions of mentally disabled, respectively, had guidelines on DNR decisions. The management of 89% of the hospitals and 94% of the nursing homes communicated their policies on EAS to physicians and nurses in their institutions without being asked. Far fewer of these hospitals (3.9%) and nursing homes (30.5%) made their policies on EAS known to patients without being asked. CONCLUSIONS: This study indicates that an important step toward policy development on EAS has been made by Dutch hospitals and nursing homes. Particularly with respect to policies on such decisions as withholding or withdrawing treatment, symptom and pain control, and DNR orders, an unexplored field is open to management for policy development in the Netherlands.

Cross-Sectional Studies↗

Coalition building and public opinion. New reproductive technologies and Canadian civil society.

The process of technology assessment is evolving. The process of policy development for technology is the least understood in the cycle of technology assessment. The process of policy development, which should involve extensive consultation and a broad-based research and evaluation program, is often fraught with difficulties and can cause further analysis or the assessment process to come grinding to a halt. This article reviews some social, political, and ethical issues and the role of civil society in influencing the technology assessment process for new reproductive technologies in Canada. It is written from the perspective of one of the Deputy Directors of Research and Evaluation for the Royal Commission on New Reproductive Technologies and highlights the strengths and difficulties of technology assessment when civil society and technology assessment come face to face. A brief update by a policy analyst in Health Canada on the current situation of legislation on new reproductive technologies has been provided and is included at the end of this article.

Advisory Committees↗

Continuing health care: the local development of policies and eligibility criteria.

In 1995 the Department of Health issued guidance on continuing health care following the health service commissioner's finding against Leeds Health Authority for failing to provide long-term care. Under this guidance, health authorities were required to agree continuing health care policies and eligibility criteria with fundholders and local authorities. This study sought to investigate the extent to which the drafting of local policies and criteria, within the framework of national guidance, led to consistency between health authorities. A structured content analysis was conducted of all the policies and eligibility criteria in three regions. In particular, it aimed to establish the comprehensiveness of local policies, the nature of local criteria, the consistency of each between authorities and with the guidance, the development of plans for reinvestment and the balance between institutional and domiciliary services. Only a minority of authorities were found to have identified investments in services, notwithstanding the requirement to do so in the guidance. In addition, most documents were not comprehensive in their coverage of client groups, with more information being provided about services for older people and those with mental health problems. Few policies contained action plans to translate general intentions about equity and consistency into practice. Eligibility criteria frequently took the form of descriptions of services and/or were so general that they would be difficult to apply in individual cases. Most documents contained no criteria for community health services. Whilst just over half of them included the aim of moving resources from acute to community sectors, they contained far more detail about institutionally based services and, for a number of reasons, appeared likely to reinforce the imbalance towards the latter. The documents analysed were part of an evolutionary process of understanding the contribution of effective continuing care to managing pressures on acute beds. Their impact on patients and their families must, however, await the findings from subsequent stages of this research.

Journal Article↗