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PubMed1987

Decree No. 85-766, 23 May 1985.

This Decree creates a High Council for the Family and Population and regional councils. The High Council is to examine the general orientation of the policy to promote the family, family planning, and population and is to determine the large outline of programs and plans of action of the National Office of the Family and Population. Similarly, the High Council is to examine objectives set by development plans with respect to the above and the means necessary to carry them out. In addition, the High Council is authorized a) to make proposals with respect to anything relating to family policy and population questions; and b) to request the preparation of studies and reports that will help it accomplish its mission, in particular, in areas concerning perspectives of demographic growth in the middle and long term and their effect on the different policies of economic and social development and on the equilibrium and well being of the family. It is also to study all questions submitted to it by a consultative commission for the family and population. Further provisions of the Decree set forth the composition and procedures of the High Council, as well as those of the regional councils, which are to be consulted on regional programs and plans of action relating to the promotion of the family, family planning, and population. Decree No. 87-713 of 11 May 1987 (Journal Officiel de la Republique Tunisienne, No. 37, 22 May 1987, pp. 692-693) makes modifications of a technical nature to Decree No. 85-766.

Africa↗
PubMed1996

Metropolitan health policy development: barriers to implementation.

The complex health issues facing urban areas require effective public policy responses. Consistent with the call by the Institute of Medicine for local health policy development, a variety of groups within metropolitan areas have engaged in these efforts. This paper provides an exploratory analysis of a cross section of 25 health policy initiatives undertaken in Chicago from 1987 through 1994. Characteristics of these initiatives, their recommendations, and factors which served as barriers to implementation are identified. The barriers include: deficiencies in policy design, inadequate political support, organizational barriers, and resource constraints. Our findings are compared to other policy implementation research. Suggestions for improving the effectiveness of local policy development include: involving key individuals from the public and private sectors, maintaining a strategic perspective on achieving priority recommendations, including financial analysis and planning, developing an initial implementation plan, and securing political support.

Chicago↗
PubMed1996

Health care reform and the role of public health agencies.

Experience in developing a local public health program, covering a period of approximately 45 years, is described. Included are the assessment and analysis of problems, policy formulation, plan development, and program implementation. A study of problems of seasonal farm workers, particularly those who migrate, is described, as well as a health services delivery program based on this study. Attention is given to incorporation of medical care with core public health services, and the use of a multidisciplinary team. Special features required to overcome cultural, language, educational, and other barriers are outlined. Adaption of knowledge gained from the migrant health project toward meeting needs of the county's medically underserved population is described. Involvement of the community, including representatives of private and public sectors, in the development and implementation of plans is emphasized. Maintaining appropriate emphasis on preventive aspects is discussed, together with mobilization of financial and other support. The importance of qualified public health staff is also emphasized: residency programs for physicians and dentists and training for other personnel are described.

Florida↗
PubMedDate not supplied

Adapting the sample size planning of a phase III trial based on phase II data.

Traditionally, in clinical development plan, phase II trials are relatively small and can be expected to result in a large degree of uncertainty in the estimates based on which Phase III trials are planned. Phase II trials are also to explore appropriate primary efficacy endpoint(s) or patient populations. When the biology of the disease and pathogenesis of disease progression are well understood, the phase II and phase III studies may be performed in the same patient population with the same primary endpoint, e.g. efficacy measured by HbA1c in non-insulin dependent diabetes mellitus trials with treatment duration of at least three months. In the disease areas that molecular pathways are not well established or the clinical outcome endpoint may not be observed in a short-term study, e.g. mortality in cancer or AIDS trials, the treatment effect may be postulated through use of intermediate surrogate endpoint in phase II trials. However, in many cases, we generally explore the appropriate clinical endpoint in the phase II trials. An important question is how much of the effect observed in the surrogate endpoint in the phase II study can be translated into the clinical effect in the phase III trial. Another question is how much of the uncertainty remains in phase III trials. In this work, we study the utility of adaptation by design (not by statistical test) in the sense of adapting the phase II information for planning the phase III trials. That is, we investigate the impact of using various phase II effect size estimates on the sample size planning for phase III trials. In general, if the point estimate of the phase II trial is used for planning, it is advisable to size the phase III trial by choosing a smaller alpha level or a higher power level. The adaptation via using the lower limit of the one standard deviation confidence interval from the phase II trial appears to be a reasonable choice since it balances well between the empirical power of the launched trials and the proportion of trials not launched if a threshold lower than the true effect size of phase III trial can be chosen for determining whether the phase III trial is to be launched.

Clinical Trials, Phase II as Topic↗
PubMed2004

An action research on the development of a caring curriculum in Taiwan.

The purpose of this study was to plan, develop, implement, and evaluate the effectiveness of the first-year course of a 5-year nursing caring curriculum. An action research method involving participant observation investigated how 18 instructors in a junior college nursing program implemented caring in the course. Data gathered through observation, interviews, and questionnaires were used for evaluation and revision of the course. Results included development of the framework for the caring curriculum and the contents of the first-year course, Introduction to Caring. Course content included the concepts of caring ("love and sincerity," "caring communication," "empathy and respect," "acceptance and trust," and "offering of self"), performance of caring actions ("care of self," "care of family members," and "care of peers"), and caring motivations ("caring reinforcing factors" and "caring restraining factors"). Teaching strategies included role modeling, dialogue, reflection, journaling, and caring groups. Evaluation showed that student caring knowledge, attitudes, and behavior improved after course implementation.

Curriculum↗
PubMed1992

[Migration, urbanization, and development policy in Senegal].

"The various studies focussing on human settlements in Senegal show that the share of population living in cities is ever increasing because of the massive and continuous flow from rural areas. The persistance of such migration trends from the country to cities deepens regional disparities, compounds the difficulties and cost of city management and development, specially in the case of Dakar, and runs counter to the goals of social and economic development plans.... The growing importance of such phenomena calls for the designing of corrective measures in favour of rural areas and small towns in order to settle rural populations and halt the inordinate and chaotic geographical growth of large cities. Failing this, development efforts may well be compromised." (SUMMARY IN ENG)

Africa↗
PubMed1988

Despacho No. 381, 27 June 1988.

This Despacho sets forth the organization and functioning of administrative departments in Venezuela's Ministry of the Family. Among the Directorates of the Ministry are the General Sectoral Directorate for Attention to the Family, the General Sectoral Directorate for Attention to Children, the General Sectoral Directorate for Attention to Youth, the General Sectoral Directorate for the Promotion of Women, and the General Sectoral Directorate for Attention to the Elderly. The following are the duties of the General Sectoral Directorate for the Promotion of Women: 1) to agree and coordinate with public and private organizations on the planning and execution of programs designed to achieve the participation of women in the socioeconomic development of the country; 2) to promote and develop plans and programs relating to the occupation and employment of women and the defense and improvement of their standard of living; 3) to formulate and promote plans and programs directed at obtaining information and social, legal, and economic assistance for women, which will support the process of their incorporation into the socioeconomic, cultural, and political spheres of the country; 4) to develop orientation and education programs relating to the legal and social rights of women; 5) to carry out studies and research relating to the position and condition of women within the national context and to promote the participation of the public and private sectors in these studies and research; 6) to direct, coordinate, and supervise the execution of programs designed to encourage the social protection of women within the institution of the family; 7) to coordinate, promote, and organize the implementation of programs designed to inform and orient women about social, cultural, and recreational activities; 8) to maintain relations with national and international organizations related to its area of competence; and 9) to carry out other duties set by laws, regulations, and resolutions.

Adolescent↗
PubMed1987

Methodology for the rational development of methotrexate analogs in the clinic.

This paper suggests a development plan for antifolate analogs, based upon disease classifications that the National Cancer Institute has successfully utilized for the development of anthracycline and platinum analogs. Diseases are classified according to the role of the parent compound in standard therapy: 1) those in which methotrexate is an important component of standard treatment strategies that have state-of-the-art effectiveness; 2) those in which methotrexate has antitumor activity but no clear role in standard state-of-the-art treatment strategies; and 3) those in which methotrexate has insufficient activity to warrant its use alone or in combination. Developmental plans are specified for each of these disease classes. Trimetrexate is used as a specific example for these plans, although this method of drug development is equally applicable to other methotrexate analogs.

Antibiotics, Antineoplastic↗
PubMed2006

Model-based drug development: the road to quantitative pharmacology.

High development costs and low success rates in bringing new medicines to the market demand more efficient and effective approaches. Identified by the FDA as a valuable prognostic tool for fulfilling such a demand, model-based drug development is a mathematical and statistical approach that constructs, validates, and utilizes disease models, drug exposure-response models, and pharmacometric models to facilitate drug development. Quantitative pharmacology is a discipline that learns and confirms the key characteristics of new molecular entities in a quantitative manner, with goal of providing explicit, reproducible, and predictive evidence for optimizing drug development plans and enabling critical decision making. Model-based drug development serves as an integral part of quantitative pharmacology. This work reviews the general concept, basic elements, and evolving role of model-based drug development in quantitative pharmacology. Two case studies are presented to illustrate how the model-based drug development approach can facilitate knowledge management and decision making during drug development. The case studies also highlight the organizational learning that comes through implementation of quantitative pharmacology as a discipline. Finally, the prospects of quantitative pharmacology as an emerging discipline are discussed. Advances in this discipline will require continued collaboration between academia, industry and regulatory agencies.

Adult↗
PubMedDate not supplied

Behavior treatment programs, readability, and treatment outcomes.

Reading grade level and readability are rarely considered as important variables in the implementation and outcome of behavior treatment plans. In the first of two studies, we analyzed the reading level and readability of 20 behavior treatment plans developed by certified behavior analysts. We found that the behavior plans were written at college reading level-well above the reading level of the average frontline staff member. On a test of readability, none of the behavior plans met criterion on all 12 critical readability variables. To test if there was a correlation suggestive of a relationship among reading grade level, readability, and treatment outcomes, we divided the behavior treatment plans into two groups; 10 that had relatively high readability levels and 10 that had relatively low readability levels. A comparison of the two groups indicated that the average reading level of the behavior plans in both groups was about the same, and the higher readability had somewhat better treatment outcomes. In the second study, we used a multiple baseline design across four individuals to directly assess the effects of manipulating reading grade level and readability of behavior treatment plans on treatment outcomes. Results showed that these manipulations greatly enhanced treatment outcomes of all four individuals. Our data suggest that reading grade level and readability of behavior treatment plans are important variables that directly affect treatment outcomes.

Adult↗
PubMedDate not supplied

Growing an industry: how managed is TennCare's managed care?

In 1994 Tennessee moved virtually its entire Medicaid population and new eligibles into fully capitated managed care (TennCare). We analyze Tennessee's strategy, given limited existing managed care; and health plans' development of managed care infrastructure. We find signs of progress and developing infrastructure, but these are threatened by concerns over TennCare's financial viability and the state's commitment to TennCare's objectives. State policymakers seeking systems change need to recognize the substantial challenges and be committed to long-term investment.

Cost Control↗
PubMed1995

[Some comments on public health service and city health planning].

This paper gives a short presentation on some of the difficulties a public health officer has to face concerning questions of town-planning. The focus is on giving an expert opinion on development plans. It may be said that the public health service and "health" often play minor roles in town planning. The article presents some suggestions for a change of this situation.

City Planning↗
PubMedDate not supplied

A ten-step process to develop case management plans.

The use of case management plans has contained cost and improved quality of care successfully. However, the process of developing these plans remains a great challenge for healthcare executives. In this article, the author presents the answer to this challenge by discussing a 10-step format process that administrators of patient care services and case managers can adapt to their institutions. It also can be used by interdisciplinary team members as a practical guide to develop a specific case management plan. This process is applicable to any care setting (acute, ambulatory, long term, and home care), diagnosis, or procedure. It is particularly important for those organizations that currently do not have a deliberate and systematic process to develop case management plans and are struggling with how to improve the efficiency and productivity of interdisciplinary teams charged with developing case management plans.

Case Management↗
PubMedDate not supplied

A ten-step process to develop case management plans.

The use of case management plans has contained cost and improved quality of care successfully. However, the process of developing these plans remains a great challenge for healthcare executives, in this article, the author presents the answer to this challenge by discussing a 10-step formal process that administrators of patient care services and case managers can adapt to their institutions. It also can be used by interdisciplinary team members as a practical guide to develop a specific case management plan. This process is applicable to any care setting (acute, ambulatory, long term, and home care), diagnosis, or procedure. It is particularly important for those organizations that currently do not have a deliberate and systematic process to develop case management plans and are struggling with how to improve the efficiency and productivity of interdisciplinary teams charged with developing case management plans.

Case Management↗
PubMed2001

Comparative studies on limb morphogenesis in mice and bats: a functional genetic approach towards a molecular understanding of diversity in organ formation.

The basis of species-specific morphogenesis has been a topic of fascination and speculation for centuries. In 1828, Karl Ernst von Baer noted that at the pharyngula stage of development all vertebrate embryos are morphologically very similar. Most subsequent hypotheses have proposed that the vertebrate body plan develops by a conserved mechanism, and that divergent forms develop by differential elaboration on this basic plan. Gene cloning and expression studies have largely confirmed that the genetic pathways of embryonic patterning are highly conserved. The finding that the proteins encoded by paralogous and orthologous genes within and between species can functionally replace each another is no longer novel; in most cases this is the expected result. How, then, does divergent morphology arise between species? One hypothesis that fits well with comparative data is that divergent morphogenesis arises from genetic differences in the timing, level and pattern of orthologous gene expression during development. This idea is being tested using a functional genetic approach comparing limb morphogenesis between the mouse and bat.

Animals↗
PubMed1999

[Contribution of explanatory notes. Efficacy of the ICH plan for international clinical development of a new drug].

After the achievement of the Phase 1 of the ICH process (ICH4, Brussels, July 1997) and the recent adoption of two new Efficacy Guidelines (E5, E9) by the ICH Steering Committee, the Pharmaceutical Industry and CROs have today the necessary tools and standards of reference, to set up a Global Plan of Clinical Development for any New Molecular Entity for Human Use, within the three ICH Regions, Europe, Japan and the USA. However to achieve such a goal, the Efficacy Guidelines must officially be integrated in the Regulatory requests of each of the 3 ICH Regions ans implemented by Industry. The use of these Guidelines which concern the Clinical Development Plan and most of the content of the Clinical Documentation for Registration of New Medicinal Products, will show the qualities and defects of ICH texts, leading in the future to possible amendments, during the maintenance phase of these Guidelines (Step6 of ICH process?). The Efficacy texts cannot be separated from other ICH Guidelines concerning Quality, Safety ans above all the Multidisciplinary texts which are of great interest for the clinical development plan, registration and follow up after MAA of any New Medicinal Product. Referring to Ethnic differences between the three ICH Regions, topic E5 is the most innovative of Efficacy Guidelines for both Regional Regulatory Authorities, accepting or not foreign clinical data and International Companies, setting up Global Clinical Plan and Registration Dossier. The paper is also looking at the future impact of the other Efficacy (E10) and Multidisciplinary (M1 to M4) Guidelines which are still under consideration.

Drug Therapy↗
PubMed1995

Service needs, receipt, and outcomes for types of clients with serious and persistent mental illness.

Classifying clients with serious and persistent mental illness (SPMI) into groups with differential demographic and clinical characteristics that relate directly to the need and receipt of services and changes in functioning provides a strong foundation on which to build program- or system-level planning, development, and evaluation efforts. In this study, clinician-generated problem data and cluster-analytic techniques were used to develop a four-group typology for a sample of 293 clients with SPMI. Each of the types--extremely disabled, young adult, personally distressed, and adapted--was profiled demographically and clinically in terms of human service needs, prognosis, and treatment outcomes. Each of the four types evidenced a unique pattern of needs and outcomes that was consistent with its clinical profiles. The typology, associated service needs, and outcomes provide valuable information for use in service planning and program development for clients with SPMI.

Adaptation, Psychological↗
PubMed1984

Health promotion approaches to occupant protection: an epidemiologic framework.

The size of the problem, the potential for prevention, and the Nation's prevention priorities all support public health action to prevent injuries. A balanced approach to this problem should include both environmental and health promotion strategies. Centers for Disease Control (CDC) is encouraging development of health promotion capability at the community level; the approach bases planning and implementation of programs on epidemiologic analysis to define the problem. Behavioral risk factor surveillance data will help states and communities establish baselines and determine priorities. Baseline data from the state-based surveillance system illustrate risk levels of motor vehicle occupants, e.g., 58% of adults report "seldom" or "never" using seat belts, and one of every seven males ages 18-34 report driving after having too much to drink. A health promotion plan developed by the Oakland County, Michigan, Health Department illustrates the use of these kinds of data as an epidemiologic framework; this plan identifies child passenger safety as a priority for action and establishes measurable objectives to reduce risk through health promotion programs. Health promotion includes not only interventions that support individual behavior change but also community change. By acquiring epidemiologic data and conveying it both to individuals and community decision makers, the public health community supports increased community efforts to protect occupants of motor vehicles.

Adolescent↗