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Rituximab: the first monoclonal antibody approved for the treatment of lymphoma.

Rituximab, a genetically engineered monoclonal chimeric antibody, targets the CD20 antigen expressed on B cells. It was approved by the US Food and Drug Administration on November 26, 1997, for the indication of relapsed or refractory, CD20-positive, B-cell, low-grade or follicular non-Hodgkin's lymphoma (LG/F NHL), and by the European Agency for the Evaluation of Medicinal Products on June 2, 1998, for therapy of patients with Stage III/IV, follicular, chemoresistant or relapsed NHL. Eight Phase II or II clinical trials in LG/F NHL patients have been completed: five single-agent studies and three combination studies. Rituximab has a favorable safety profile: most adverse events (AEs) are Grade 1 or 2, and the frequency of AEs decrease with subsequent infusions. AEs in the combination studies are consistent with those seen with individual agents. For evaluable patients in the single-agent studies, overall response rates (ORR) ranged from 40% to 60%, median duration of response (DR) ranged from 5.9 to 15.0+ months, and median time to progression (TTP) ranged from 8.1 to 19.4+ months. For evaluable patients in the combination studies, the ORR ranged from 45% to 100%, median DR ranged from 11.7+ to 39.1+ months, and median TTP ranged from 12.9+ to 40.5+ months. Studies in intermediate- and high-grade NHL are ongoing. Long-term development plans include evaluating the safety and efficacy of rituximab in various types of lymphoma and in combination with other lymphoma regimens. Future studies may explore ways to increase rituximab efficacy by upregulating CD20 or increasing effector function with different cytokines.

Animals↗

The crisis in U.S. and international cancer policy.

The incidence of cancer in the United States and other major industrialized nations has escalated to epidemic proportions over recent decades, and greater increases are expected. While smoking is the single largest cause of cancer, the incidence of childhood cancers and a wide range of predominantly non-smoking-related cancers in men and women has increased greatly. This modern epidemic does not reflect lack of resources of the U.S. cancer establishment, the National Cancer Institute and American Cancer Society; the NCI budget has increased 20-fold since passage of the 1971 National Cancer Act, while funding for research and public information on primary prevention remains minimal. The cancer establishment bears major responsibility for the cancer epidemic, due to its overwhelming fixation on damage control--screening, diagnosis, treatment, and related molecular research--and indifference to preventing a wide range of avoidable causes of cancer, other than faulty lifestyle, particularly smoking. This mindset is based on a discredited 1981 report by a prominent pro-industry epidemiologist, guesstimating that environmental and occupational exposures were responsible for only 5 percent of cancer mortality, even though a prior chemical industry report admitted that 20 percent was occupational in origin. This report still dominates public policy, despite overwhelming contrary scientific evidence on avoidable causes of cancer from involuntary exposures to a wide range of environmental carcinogens. Since 1998, the ACS has been planning to gain control of national cancer policy, now under federal authority. These plans, developed behind closed doors and under conditions of nontransparency, with recent well-intentioned but mistaken bipartisan Congressional support, pose a major and poorly reversible threat to cancer prevention and to winning the losing war against cancer.

Developed Countries↗

Evaluation of comprehensive program for diabetes care at primary health-care level.

The Swedish National Board of Health and Welfare published its first diabetes health-care program in 1977. The impact of the program was evaluated in the Stockholm County after 4 yr. The results showed that the educational program had reached greater than or equal to 1 staff member in 86% of the 104 primary health-care centers (PHCCs). Several organizational changes had taken place as a result of the program. The 10 "best" PHCCs were compared with a random sample of the centers with regard to patient outcomes. Patients from the 10 best centers had gotten a more comprehensive education, were more knowledgeable about foot care, tested glucose more often, and used less medication. The metabolic control was the same for both groups of patients. The PHCC staffs reported the following roadblocks to change: lack of knowledge of diabetes care, insufficient cooperation between staff members, poor contact with specialists, and absence of guidelines for diabetes care. The staffs in the best centers spent twice as much time in staff meetings and continuing education as those from the random sample of centers. The findings led us to formulate a new strategy for the program. The main objective of the new approach is to create organizational changes within the centers. Thus, local knowledge and creativity can be utilized. Preliminary data demonstrate that 84% of the locally developed plans for reorganization of diabetes care had been accomplished within 1 yr.

Diabetes Mellitus↗

Initiating exercise programs for patients with non-insulin-dependent diabetes.

Considerable attention has been focused on the importance of physical activity in improving the diabetic state in obese, non-insulin-dependent diabetic patients. Because this patient population tends to be sedentary, this challenge requires an active effort involving the patient and health-care providers. The latter may be a team including physician, dietitian, nurse practitioner, and physical therapist. Programs must be individualized. The patient must be a full partner in developing plans and goals. Plans should represent the patient's interests, should blend into the daily schedule, and should avoid boredom. Programs are adapted to the patient's physical condition and are graduated in duration and intensity. Motivation is stimulated through education and is reinforced both by self-monitoring techniques and monitoring by providers. Such programs add a new dimension to both physical and psychological well-being.

Diabetes Mellitus↗

Clinical trials in paediatric oncology. Recommendations for the development of new anticancer agents.

Childhood and adolescent cancers are rare diseases. Despite the progress in treatment (more than two-thirds of all cases are cured), cancer remains the leading cause of death by disease in children older than 1 year. Access to new drugs that are more efficacious or better tolerated is therefore an important public health priority. The objective of our round table was thus to take inventory of the situation and to propose recommendations aimed at facilitating coordinated, rational and more rapid access to new treatments. The active participation of paediatric oncologists, parents, pharmaceutical companies and regulatory authorities proved not only necessary but very constructive. Pharmaceutical companies have developed very few new anticancer agents for children during the past 10 years. The round table identified current trends that appear propitious: the mobilisation of parents and patients' associations; European initiatives to encourage companies to assess drugs in children; regulatory initiatives to guide drug development; and the existence of structured clinical research networks in paediatric oncology, including for the development of early treatment. The round table recommends the following measures to improve access to new treatments for children and adolescents with cancer: 1. Conduct preclinical paediatric evaluation of all anticancer agents that begin the development process for adults (research and validation of treatment targets; pharmacological evaluation in relevant experimental models) to help choose the agents to study in children. 2. Initiate paediatric clinical development before the first application for authorization for adults is filed, when sufficient safety and tolerability data are available, that is, after the phase I trials in adults and optimally during the phase II trials. 3. Optimise paediatric clinical evaluation by defining development plans early and by reducing the duration of studies (enlargement of the early treatment research network to ensure adequate recruitment; new evaluation methods; better extrapolation of pharmacological data from adults to children for dose-finding). 4. Improve information to and participation of parents and patients in clinical research for new treatments. The prerequisite for the success of this project became rapidly clear to all the round-table participants: cooperation and partnership between specialists and other scientists from academia, parent associations, pharmaceutical companies and regulatory authorities. Only with such cooperation can progress in treatment occur and new hopes for recovery be fulfilled.

Adolescent↗

Trieste PACS project: a functional assessment.

A picture archiving and communication (PAC) system (CommView by AT&T and Philips) has recently been installed in the Radiology Department of the University of Trieste, Italy, and is currently under experimental evaluation. The current status of the system and the planned developments are reported. A major project at present is the evaluation of the impact of the PAC system on the radiology system on a functional basis, by applying in the medical field a modelling methodology developed to analyse manufacturing systems. Other research in progress is devoted to technical, clinical and ergonomic aspects, on the basis of a comprehensive assessment project.

Hospital Information Systems↗

Social isolation: unit-based activities for impaired elders.

Loneliness can lead to illness and death, and is such a painful experience that a resident may not verbalize it directly. Quality nursing care requires that problems of social isolation are identified and a plan developed for adequate intervention. Impaired residents will be more successful socially when they can access a variety of interesting activities in small groups where familiar staff take initiative and establish a rapport. Institutional nurses are in a unique position to request the structural and personnel changes necessary to bring creative activities to the nursing units of impaired elders.

Aged↗

Tangling with the barriers to culture change: creating a resident-centered nursing home environment.

Prior to beginning culture change, nursing homes should analyze potential barriers, such as staff turnover, and develop plans to deal with these barriers. Infusion of culture change is dependent on inversion of the organizational structure, placing decision-making in the hands of the older adults. Although data from this study indicated decreased depression in older adults and increased family satisfaction with culture change, there were many confounding variables. Evaluation of culture change can be enhanced by using repeated measures and qualitative techniques.

Adult↗

The role of the interdisciplinary team in using psychotropic drugs.

1. The use of psychotropic medications to control unacceptable or maladaptive behaviors should be an integral part of the client's active treatment plan developed by the interdisciplinary team. 2. Ideally, psychotropic medication is used for behavioral management only after less restrictive programmatic alternatives have been exhausted, and then only in conjunction with a behaviorally based training program. 3. Attitudes and beliefs of individual team members will contribute to the success or failure of the interdisciplinary team process.

Antipsychotic Agents↗

Using quality-control analysis of peak expiratory flow recordings to guide therapy for asthma.

OBJECTIVE: To compare the action points in published asthma management plans with those derived from quality-control analysis of peak expiratory flow recordings. DESIGN: Longitudinal observational study. SETTING: An ambulatory asthma education and management program in a tertiary care hospital. PATIENTS: 35 adults with asthma and exacerbation of asthma. MEASUREMENTS: Peak expiratory flow diaries and symptom recordings. RESULTS: Asthma action points from published asthma management guidelines had poor operating characteristics. The success rate was 35% when the action point was a peak expiratory flow rate less than 60% of the patient's best peak flow. The success rate improved to 88% when the action point was a peak expiratory flow rate less than 80% of the patient's best peak flow. Published action points had a high failure rate. Peak flow decreased to below the published action points during a stable period of asthma in 7% to 51% of patients studied. Action points defined using quality-control analysis did significantly better. A peak flow value less than 3 standard deviations below the patient's mean peak flow detected 84% of exacerbations and had a low failure rate (19%). Other quality-control tests had sensitivities of 91% and 71%. Quality-control action points could detect exacerbations up to 4.5 days earlier than conventional methods. CONCLUSIONS: Individualized action points can be derived for patients with asthma by applying quality-control analysis to peak flow recordings. These action points are more sensitive in detecting exacerbations of asthma and have fewer false-positive results. Action plans developed in this manner should be more useful for the early detection of deteriorating asthma.

Adrenal Cortex Hormones↗

Medicine in resource-poor settings: time for a paradigm shift?

The current global health system, which concentrates on a few and neglects billions of people who live in resource-poor settings and carry the largest burden of global diseases, is unacceptable. The weight of medical practice patterns ought to shift from the therapeutic phase of medical care to prevention. Achieving better health for the majority of humanity requires innovation, improved resources, new cooperation between the rich and the poor, and a clear ethical vision, consolidated by goal-oriented and system-focused strategic health planning. Development assistance from wealthier nations to developing countries must shift from the current donor-driven agendas to country-driven sector-wide approaches for health development with adequate accountability and sustainability. There must be a fundamental departure from classical universalism to new universalism, reoriented by a new public health, and reinforced by a new solidarity, using holistic approaches to ensure better health for the whole of humanity.

Developing Countries↗

Use of objective structured clinical examinations (OSCEs) in training and evaluating community health aides.

Community Health Aides (CHAs) provide village-based health services throughout Alaska. The Objective Structured Clinical Examination (OSCE) was developed approximately 20 years ago in Scotland in an effort to make exams more valid, reliable, and practical. OSCEs have been used by medical schools to assess more objectively a variety of clinical skills; this structured examination format is being used during the four four-week basic training sessions for CHAs to assess clinical competency in both common problem and critical skills. The OSCE consists of multiple-timed stations where each CHA is presented with the same situation and evaluated using a check list of predetermined detailed evaluation criteria. In the regular clinical setting CHAs demonstrate skills managing a variety of medical problems; the OSCE setting presents each examinee with an identical, controlled, simulated situation in which only particular skills are evaluated. The testing stations are designed to evaluate a variety of clinical skills: history-taking, physical exam, making assessments, developing plans, using the CHA manual, documentation, reporting, laboratory and procedure techniques, and emergency skills.

Alaska↗

Design of legal audits for utilization management.

Liability for managed care risks, the enactment of detailed state regulation of utilization management and the process requirements of accreditation agencies and managed care customers all create the need for new approaches to legal auditing. Concepts from industrial quality management theory can be used to define process elements that serve the legal adequacy of the utilization management process. The information systems that record information gathered and judgments made by reviewers and generate basic notices of certification can be designed so as to produce data relevant to compliance and liability management. These key process elements then can be analyzed statistically to develop plans for preventive counseling.

Contract Services↗

'Tomlinson' in Scotland.

The Management Executive (ME) in Scotland has recently announced that between 3000 and 7000 acute sector beds are to be lost in Scotland by the year 2001, for many of the same reasons that the Tomlinson report recommended beds be cut in London. Health boards are developing plans to restructure hospital services but issues of public and professional support for the plans they produce, and questions of funding, will determine the final outcome.

Efficiency↗

Components of a successful case management program.

Many critical factors, including operational and organizational resources, must be considered and addressed to implement a successful case management program. This article provides a blueprint for establishing a program that is compatible with an organization's objectives. The authors provide a step-by-step process, from defining case management to organizing and assessing staff and data capabilities, for helping health plans develop processes to provide quality patient care.

California↗

Age-specific standards in radiology.

This article describes a plan developed by the radiology department at Sibley Memorial Hospital to meet JCAHO standards for age-specific care. The goal of the program was to improve patient care and document outcomes while complying with the standards. There are numerous references in the JCAHO standards that require recognizing physical motor/sensory, cognitive and psychosocial differences among the age groups served by an institution. One of the challenges of meeting age-specific requirements is applying them to all aspects of care that are affected. The most important part of Sibley's age-specific program is a tool called the ¿quick reference guide¿ (QRG). It was designed by the radiology department to provide detailed, comprehensive information to all staff members in an easy-to-use format. The QRG is posted prominently throughout the department. The QRG includes age-specific information for the following patient care areas in radiology: radiation protection, exposure factors, immobilization, venipuncture, medication/contrast dose, skin care, communication, patient/family education and patient safety. The JCAHO is more interested in having staff members know where to obtain information about age-specific care than in having them memorize ¿answers.¿ Having a clear and complete QRG available at all times fulfills that requirement.

Adolescent↗

Challenges to identifying actual diabetes case-mix complexity and total treatment charges.

Patient management programs are being used to improve the quality of care and decrease charges for both high-cost and potential high-cost claimants. Adequate information is key to program development, planning, and implementation. Claims-based data are a ready source of valuable information, but without proper processing, true case-mix complexity and total charges for patients will not be identified.

Cluster Analysis↗