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PubMed2004

Psychological barriers.

Type 2 diabetes treatment outcomes ultimately depend on patients and their ability to make long-term behavioural changes that support good self-care and metabolic control. Patients' perceptions about diabetes and diabetes-related complications can have a strong influence on their emotional well-being, as well as day-to-day self-care and the quality of metabolic control. The gravity of diabetes is often underestimated, and many patients do not understand the link between poor glycaemic control and long-term complications of the disease. Similarly, people with diabetes commonly undervalue the role of lifestyle changes and pharmacological therapy in preventing future complications. Negative emotions and preconceptions about treatment can also discourage adherence to treatment plans. 'Psychological insulin resistance' caused by fear and concerns about insulin and daily insulin injections can discourage many patients from starting insulin therapy, even if oral agents have failed. Depression, stress and anxiety represent further obstacles to optimum self-care and the attainment of glucose goals. Healthcare professionals should endeavour to understand and accommodate these issues when setting personal treatment goals and developing plans to achieve them. Importantly, the advice and support they provide should be tailored to the unique needs of each patient. There is scope to improve outpatient consultations to ensure agreement between patients and professionals concerning issues discussed and decisions made, and this may help to improve recall and motivation to manage diabetes. Engaging patients in the goal-setting process can help to overcome potential barriers to good self-care and may increase the probability that treatment goals are achieved.

Adaptation, Psychological↗
PubMedDate not supplied

Human immunodeficiency virus vaccine development in developing countries: are efficacy trials feasible?

The implementation of human immunodeficiency virus (HIV) vaccine efficacy trials in developing countries represents an unprecedented series of challenges for the medical and scientific communities, health authorities, policy makers, and the populations of diverse countries. Such trials require great attention, dedication, and information at the earliest possible time from many groups in these communities, as well as the clear and full collaboration of all the national and international institutions and agencies involved. This article discusses suggestions and makes recommendations regarding multiple hurdles to trial implementation, including access to appropriate populations, incidence and natural history of HRV type 1 (HIV-1) infection, definition of efficacy endpoints, and logistical, ethical, regulatory, political, and media issues. The conduct of phase I and II trials in developing countries will be a critical step for appropriate vaccine selection and in helping to identify the country- and community-specific issues and the needs for further implementation. Some countries have already established their own national HIV vaccine development plans. Additional operational and action plans with special emphasis on efficacy trial implementation would be strongly recommended after country-specific preparedness workshops and constitution of national or regional task forces.

AIDS Vaccines↗
PubMed2000

Therapeutic developments in cytomegalovirus retinitis.

The incidence of cytomegalovirus (CMV) retinitis in AIDS has declined significantly due to the use of highly active antiretroviral therapy (HAART). However, patients with HIV, especially those failing HAART, may still suffer with CMV retinitis, which can lead to significant loss of vision and blindness. Ganciclovir has traditionally been considered the recommended treatment for CMV retinitis; however, due to side effects and the possibility of developing viral resistance, other agents may be preferred in certain situations. Foscarnet, which has similar efficacy to ganciclovir but a different side effect profile, is more difficult to administer and is less well-tolerated. Intravenous cidofovir, which may be more effective than either iv. ganciclovir or foscarnet, can also be used as a first line agent; however, it is associated with toxicity (renal and ocular) and thus needs careful use. Local therapy for CMV retinitis has been a significant advance. The intraocular ganciclovir implant has the highest efficacy of the approved agents and is well-tolerated. Fomivirsen, an oligonucleotide injected intravitreally, is a newly approved agent which offers alternative treatment. Intravitreal ganciclovir or foscarnet, although not approved, have been used successfully in some patients especially those with recurrent or refractory disease. The development of new anti-CMV agents has been stalled by the decreased incidence of the disease. Valganciclovir, a prodrug of ganciclovir, offers excellent oral bioavailability and is the closest to approval of all the new anti-CMV drugs. High ganciclovir blood levels are achieved without the complications associated with the requirement for long-term iv. access. The monoclonal antibody (mAb) MSL-109, did not offer a significant advantage when added to traditional anti-CMV therapy. Development plans of other agents such as cyclic HPMPC and lobucavir have been put on hold by their respective manufacturers. Adefovir is a nucleotide analogue that possesses anti-CMV activity, but is currently only being pursued for the treatment of hepatitis B virus. Other compounds possessing significant anti-CMV activity, including BAY 38-4766 and GW1263W94 are still in the early stages of development.

Adenine↗
PubMedDate not supplied

Challenges and lessons learned since implementation of the safety pharmacology guidance ICH S7A.

The International Conference on Harmonization, Topic S7A guidance (ICH S7A) on safety pharmacology for human pharmaceuticals has been in effect for 3 years in Europe, the United States and Japan. Surveys of the pharmaceutical industry, regulatory agencies and the audience attending the 4th Annual Meeting of the Safety Pharmacology Society have helped identify and address areas of controversy, as well as those challenges that have emerged since implementation of the guidance worldwide. Overall, ICH S7A has been successfully implemented. The guidance provides for "Good Laboratory Practice" compliant "safety pharmacology core battery" of studies that are generally performed prior to first administration to humans. The approach is science-driven and specifies the use of robust and sophisticated in vitro and/or in vivo assays. There are, however, some areas that require further refinement/clarification such as the specifics of study design including the selection of dose/concentration, choice of species, modeling of the temporal pharmacodynamic changes in relation to pharmacokinetic profile of parent drug and major metabolites, use of an appropriate sample size, statistical power analysis as a means of demonstrating the sensitivity of the model system, testing of human-specific metabolites and demonstrating not only the model's sensitivity, but also its specificity for predicting adverse events in humans. There was also discussion of when these studies are needed in relation to the clinical development plan. Representatives from the pharmaceutical industry and regulatory agencies see the implementation of ICH S7A as a major step forward towards identifying the risk to Phase 1 and 2 volunteers and patients. It remains to be seen, however, whether and in what ways the ICH S7A-based strategy will contribute to the modification of the integrated risk assessment during the latter stages of clinical development or once drugs have been introduced to the marketplace.

Animals↗
PubMedDate not supplied

Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.

Many scientific discussions, especially in the past 8 yr, have focused on definition of criteria for the optimal assessment of the preclinical toxicity of pharmaceuticals. With the current overlap of responsibility among centers within the Food and Drug Administration (FDA), uniformity of testing standards, when appropriate, would be desirable. These discussions have extended beyond the boundaries of the FDA and have culminated in the acceptance of formalized, internationally recognized guidances. The work of the International Committee on Harmonisation (ICH) and the initiatives developed by the FDA are important because they (a) represent a consensus scientific opinion, (b) promote consistency, (c) improve the quality of the studies performed, (d) assist the public sector in determining what may be generally acceptable to prepare product development plans, and (e) provide guidance for the sponsors in the design of preclinical toxicity studies. Disadvantages associated with such initiatives include (a) the establishment of a historical database that is difficult to relinquish, (b) the promotion of a check-the-box approach, i.e., a tendancy to perform only the minimum evaluation required by the guidelines, (c) the creation of a disincentive for industry to develop and validate new models, and (d) the creation of state-of-the-art guidances that may not allow for appropriate evaluation of novel therapies. The introduction of biotechnology-derived pharmaceuticals for clinical use has often required the application of unique approaches to assessing their safety in preclinical studies. There is much diversity among these products, which include the gene and cellular therapies, monoclonal antibodies, human-derived recombinant regulatory proteins, blood products, and vaccines. For many of the biological therapies, there will be unique product issues that may require specific modifications to protocol design and may raise additional safety concerns (e.g., immunogenicity). Guidances concerning the design of preclinical studies for such therapies are generally based on the clinical indication. Risk versus benefit decisions are made with an understanding of the nature of the patient population, the severity of disease, and the availability of alternative therapies. Key components of protocol design for preclinical studies addressing the risks of these agents include (a) a safe starting dose in humans, (b) identification of potential target organs, (c) identification of clinical parameters that should be monitored in humans, and (d) identification of at-risk populations. One of the distinct aspects of the safety evaluation of biotechnology-derived pharmaceuticals is the use of relevant and often nontraditional species and the use of animal models of disease in preclinical safety evaluation. Extensive contributions were made by the Center for Biologics Evaluation and Research to the ICH document on the safety of biotherapeutics, which is intended to provide worldwide guidance for a framework approach to the design and review of preclinical programs. Rational, scientifically sound study design and early identification of the potential safety concerns that may be anticipated in the clinical trial can result in preclinical data that facilitate use of these novel therapies for use in humans without duplication of effort or the unnecessary use of animals.

Animals↗
PubMed1994

Health system reform: let's not miss our chance.

Support for reform is at its highest level, but criticism of President Bill Clinton's plan is widespread. Nevertheless, the core components of the Clinton plan should be supported. These include (1) building on existing employer-based health insurance with a mandate that employers offer coverage to all workers and pay a substantial portion of the premium; (2) requiring that coverage be universal and benefits comprehensive; and (3) controlling total health care spending via a national expenditure limit. This paper does, however, suggest three changes to strengthen the plan: developing a broader base than Medicare and Medicaid to pay for reform; setting the national health care spending limit at a higher level (gross domestic product plus 1 percent); and strengthening the powers of the regional health alliances.

Cost Control↗
PubMed2001

Modeling and simulation for space medicine operations: preliminary requirements considered.

The NASA Space Medicine program is now developing plans for more extensive use of high-fidelity medical simulation systems. The use of simulation is seen as means to more effectively use the limited time available for astronaut medical training. Training systems should be adaptable for use in a variety of training environments, including classrooms or laboratories, space vehicle mockups, analog environments, and in microgravity. Modeling and simulation can also provide the space medicine development program a mechanism for evaluation of other medical technologies under operationally realistic conditions. Systems and procedures need preflight verification with ground-based testing. Traditionally, component testing has been accomplished, but practical means for "human in the loop" verification of patient care systems have been lacking. Medical modeling and simulation technology offer potential means to accomplish such validation work. Initial considerations in the development of functional requirements and design standards for simulation systems for space medicine are discussed.

Aerospace Medicine↗
PubMed2002

Surgical strategy: matching the patient with the procedure.

The general indications, timing, and choice of procedure can be determined by asking and answering the following questions appropriately: 1. Has the patient achieved neurologic, emotional, and social stability? 2. What is the patient's current level of motor and sensory resources and function? The number and strength of muscles remaining under good voluntary control are the most important variables. 3. Are the patient's expectations realistic? 4. Does the patient possess the necessary intelligence and motivation? Some procedures, such as arthrodesis of a specific joint, require little motivation to succeed; however, a complex set of muscle-tendon transfers requires a great deal of motor reeducation for the patient to achieve an optimal result. 5. Does the patient have the necessary time to invest in achieving a good result? The patient must be able to set aside the time necessary for postoperative immobilization in a cast or splint and for therapy and reeducation. 6. Are the necessary support services and personnel available and committed? 7. Have all preoperative obstacles to success been considered and has a plan developed to overcome any remaining obstacles? 8. Does the patient understand the potential complications and benefits? 9. Can the patient and professional team tolerate a complication, failure, or suboptimal result? Both the medical staff and the patient must be prepared for complications that may lead to a suboptimal outcome or frank failure. 10. Are the patient's current health and well-being ideal? 11. Is the surgical plan consistent with the patient's physical resources, goals, and expectations? 12. Does an alternate plan exist? 13. Does the surgeon understand the scope of the complications and how to salvage an acceptable result should a complication occur?

Arm↗
PubMed2004

Conflict on the coast: using geographic information systems to map potential environmental disputes in Matagorda Bay, Texas.

The sustainable management of coastal natural resources inevitably involves identifying stakeholder conflicts and developing planning processes that prevent these conflicts from becoming intractable disputes. This study links environmental conflict to specific areas within a large ecological system. Specifically, we use Geographic Information Systems (GIS) to map potentially competing stakeholder values associated with establishing protected areas in Matagorda Bay, Texas. By overlaying multiple values associated with a range of stakeholders across space, we are able to identify hotspots of potential conflict as well as areas of opportunity for maximizing joint gains. Mapping stakeholder conflict is an approach to proactively locate potential controversy in response to a specific environmental management proposal and guide decision makers in crafting planning processes that mitigate the possibility of intractable disputes and facilitate the implementation of sustainable coastal policies. Results indicate that under different management scenarios, protected area proposals will generate more conflict in specific areas. Most notably, regulated uses would produce the greatest degree of conflict on or near shore, particularly at the mouth of the Colorado River. Additionally, of all the management scenarios evaluated, the prohibition of coastal structural development would generate the overall highest level of conflict within the Bay. Based on the results, we discuss the policy implications for environmental managers and provide guidance for future research on location-based conflict management within the coastal margin.

Conflict, Psychological↗
PubMed1994

Collaboration in investigator initiated public health nursing research: university and agency considerations.

There is a significant difference in the collaborative process between whether a public health nursing research project is requested (of the researchers) by the agency or if it is conceived by an outside investigator. This article discusses the underlying concepts of negotiation, mutuality, and respect that support the process of an externally initiated study in an agency. In a progressive listing format, the important components within the planning, development, implementation, and completion phases are then described so that they can be useful to beginning researchers as a guide and to experienced researchers as a reminder.

Community-Institutional Relations↗
PubMed1990

A professional preparation course on AIDS/HIV infection.

This paper describes the conceptualization, development, planning, and implementation of a new professional preparation course entitled "AIDS/HIV Education: Issues and Strategies." The 15-week, campuswide course was offered through the Dept. of Health Science Education at the University of Florida during spring semester 1990. Though universities have been identified as providers of preservice education for future teachers and health professionals, current activities often have been deemed inadequate to meet the needs of those charged with providing AIDS/HIV education. This course was implemented to address an array of issues related to HIV education, ranging from epidemiological and biomedical information and educational strategies to examination of personal and ethical issues surrounding the disease. Delivery of a successful course and student reaction are discussed, along with recommendations for programs considering similar educational efforts. A detailed planned information packet is available from the authors.

Acquired Immunodeficiency Syndrome↗
PubMedDate not supplied

Regulatory decision strategy for entry of a novel biological therapeutic with a clinically unmonitorable toxicity into clinical trials: pre-IND meetings and a case example.

The following material was derived from a synthesis of case histories taken from investigational new drug (IND) applications and drug sponsors' experiences, utilizing fictionalized data to avoid any resemblance to any proprietary information; any such resemblance is accidental. These examples are used as an instructional scenario to illustrate appropriate handling of a difficult toxicology issue. In this scenario, a drug caused a toxicity in animals that was detected only by histopathologic analysis; if it were to develop in patients, no conventional clinical methods could be identified to monitor for it. It is not unusual for a firm to cancel clinical development plans for a lead drug candidate that causes such a toxicity, especially if such a drug is intended for use as a chronic therapeutic in a population of patients with a chronic disease. This case synthesis was inspired by a Food and Drug Administration (FDA) agreement to allow such a product to proceed into clinical trials after substantive pre-IND discussions and agreement on well-considered toxicology program designs. The scientists most closely involved in the strategy development included the sponsor's toxicologist, veterinary toxicologic pathologist, and pharmacokineticist, as well as the FDA's reviewing pharmacologist. The basis of this decision was thorough toxicity characterization (1-month studies in 2 species); correlating toxicities with a particular cumulative area under the curve (AUC) in both species; identification of the most sensitive species (the species that showed the lower AUC correlating with toxicity); allometric assessment of clearance of the drug in 3 nonhuman species; construction of a model of human kinetics (based on extrapolation from animal kinetics); and finally, estimation of clinical safety factors (ratios of the human estimated cumulative AUC at the proposed clinical doses, over the animal cumulative AUC that correlated with the no adverse effect levels). Industry and FDA scientists negotiated a joint assessment of risk and benefit in patients, resulting in the FDA permitting such a compound to enter into clinical trials for a serious autoimmune disease. Such constructive, early communication starts with the pre-IND meeting, and the conduct and planning for this meeting can be very important in establishing smooth scientific and regulatory groundwork for the future of a drug under IND investigation.

Animals↗
PubMed2003

Toward an integrated management plan of the Djoudj Park water resources: Senegal River mouth.

A new approach was needed to preserve the biodiversity of the Djoudj Park within a context marked by many constraints: drought, regulation of its hydrologic system, and anthropogenic pressure. The local management plan developed in this paper aims at the responsible management and fair distribution of the available water resources in the Djoudj Park to provide a balanced response to conservation issues and the growing needs of the local communities. The opposition between an administration determined to exercise its power and the confidence of local people weary of being stripped of their rights and cultural assets required the setting up of a consensual management plan. This plan would provide a means to determine the timing and the number of sluice gates to operate, based on an efficient command of the needs for water for each activity in the park and its surroundings. This tool will allow the park authority to take full cognizance of the needs and opinions of all interest groups but also their limits while keeping the essential functions of this wetland. It is also suggested that institutional and administrative reform be carried out to associate local populations in the definition and implementation of criteria for an integrated management of the Djoudj resources.

Agriculture↗
PubMedDate not supplied

Managing biotechnology in a network-model health plan: a U.S. private payer perspective.

Emerging biotechnology poses challenges to payers, including access, coverage, reimbursement, patient selection, and affordability. Premera Blue Cross, a private regional health plan, developed an integrated cross-functional approach to managing biologics, built around a robust formulary process that is fast, flexible, fair, and transparent to stakeholders. Results are monitored by cost and use reporting from merged pharmacy and medical claims. Utilization management and case management strategies will integrate with specialty pharmacy programs to improve outcomes and cost-effectiveness. Creative approaches to provider reimbursement can align providers' incentives with those of the plan. Redesign of member benefits can also encourage appropriate use of biotechnology.

Biological Products↗
PubMedDate not supplied

Organizing quality assurance in a maternal-child health division.

The 10-step monitoring and evaluation process is described and applied to a maternal-child health division of a 300-bed tertiary care hospital. Examples of specific important aspects of care and indicators are given. The organized plan developed for this division is examined using the Joint Commission on Accreditation of Healthcare Organization's guidelines.

Communication↗
PubMed1995

A community-wide RN refresher course: a collaborative success.

By combining forces, nurse educators and practitioners developed a unique RN refresher course that provided a supportive environment for successful reentry into professional nursing practice. Nursing faculty and administrators from a baccalaureate nursing program collaborated with nursing clinicians from seven acute care hospitals to meet the assessed needs of community nurses for reentry programs. The collaborative effort provided accessible courses at lower costs with qualified faculty and a variety of clinical practice experiences for nurses areawide. This article describes the planning, development, implementation, and analysis of this successful areawide RN refresher course.

Community Health Nursing↗