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The paper discusses the state of the art in adjuvant treatment of breast cancer patients. The protocol of the randomized controlled study of the effectiveness of adjuvant chemohormonotherapy conducted at the Petrov Institute since January, 1985 is presented. It is suggested that all oncological institutions concerned should take part in a cooperative investigation to be carried out along the guidelines outlined in the protocol.
This paper reflects on issues related to health information reform in countries of Eastern Europe. Drawing on recent health information systems planning initiatives in central and eastern Europe, the evolution of health information in Canada, and other international developments, as well as consulting experiences in Poland, Belarus, and Ukraine over the past four years, observations and recommendations are offered for assisting health information reform. Definitions of health and health information, a model for allocating resources for health services, and a conceptual framework for community health information used in Canada are presented.
The Nordic organ exchange organization Scandiatransplant was founded in 1969. It covers a population of 24.41 million inhabitants in five countries: Denmark (5.45 million), Finland (5.19 million), Iceland (0.29 million), Norway (4.54 million), and Sweden (8.94 million). Initially, the purpose of Scandiatransplant was to establish and maintain a common waiting list for all Nordic patients with end-stage renal failure waiting for a cadaveric kidney transplant. The basis of maintaining a common Nordic waiting list was the recognition of the wide polymorphism of the human leukocyte antigen system, which demands a substantial pool of waiting patients to provide optimal histocompatibility matching between organ donor and recipient. Thus, one of the major tasks of the organization was and still is to specify rules for the exchange of kidneys between the participating transplant centers. Scandiatransplant includes the cooperation of all 10 Nordic kidney transplant centers in addition to eight immunology laboratories. Denmark has four transplant centers located in Copenhagen, Herlev, Odense, and Aarhus. Finland has one center in Helsinki. Norway has one center located in Oslo. Sweden has four kidney transplantation centers located in each of the university hospitals in Göteborg, Malmö, Stockholm, and Uppsala. The fifth Nordic country, Iceland, is participating fully in organ donation but has no individual transplant center. Organ transplantation in Icelandic patients is performed in other Nordic countries.
A total of 361 evaluable patients with previously untreated multiple myeloma were randomized to receive oral melphalan (0.15 mg/kg/day for seven days, followed by 0.05 mg/kg/day after recovery from the nadir of the leukocytes), BCNU (150 mg/m2 intravenously every six weeks) or CCNU (100 mg/m2 orally every six weeks). All patients received a tapering six-weeks) or CCNU (100 mg/m2 orally every six weeks). All patients received a tapering six-week course of prednisone starting at 0.8 mg/kg for the first two weeks. At week 22, one-half of the patients were randomized to receive vincristine (1 mg/m2) and prednisone (0.6 mg/kg for seven days) every two months in addition to previous therapy. The melphalan treated patients showed a significantly higher overall objective response frequency (59%), according to Myeloma Task Force criteria, when compared to those treated with BCNU (40%) or CCNU (42%). The survivals for all patients were not statistically different for the three treatment programs. However, the good-risk patients treated with melphalan had significantly longer survival (P = 0.02) than the equivalent patients who received BCNU or CCNU. The addition of vincristine and prednisone at week 2 did not significantly increase the percentage of subsequent objective responses or prolong the subsequent survival of any treatment group. It is concluded that oral melphalan is superior to BCNU and CCNU in producing objective responses and in prolonging survival in good risk patients.
We performed a multicenter, randomized, controlled clinical trial of therapeutic peritoneal lavage (2 liters per hour for three days) in 91 patients with severe acute pancreatitis. Patients were entered into the study if severe pancreatitis was indicated by multiple laboratory criteria or diagnostic peritoneal lavage. All patients received full supportive treatment. The median time between the onset of symptoms and randomization was 38 hours. Forty-six patients were assigned to the control group and 45 to the lavage group. There were 13 deaths (28 per cent) and 16 patients with major complications (35 per cent) in the control group, as compared with 12 deaths (27 per cent) and 17 patients with major complications (38 per cent) in the lavage group. Lavage did not appear to modify the length of survival, the incidence of pancreatic collections (pseudocysts or abscesses), or the plasma amylase concentration. Considering the statistical power of the design, we conclude that the outcome of severe pancreatitis was not greatly, if at all, influenced by the regimen of peritoneal lavage used in this study.
The Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT) announces the availability of FY 1999 funds for the following activities. These activities are discussed in more detail under Section 3 of this notice. This notice is not a complete description of the activities; potential applicants must obtain a copy of the Guidance for Applicants (GFA) before preparing an application. (See table.) Note: SAMHSA also published notices of available funding opportunities for FY 1999 in subsequent issues of the Federal Register. The actual amount available for awards and their allocation may vary, depending on unanticipated program requirements and the volume and quality of applications. Awards are usually made for grant periods from one to three years in duration. FY 1999 funds for activities discussed in this announcement were appropriated by the Congress under Public Law No. 105-277. SAMHSA's policies and procedures for peer review and Advisory Council review of grant and cooperative agreement applications were published in the Federal Register (Vol. 58, No. 126) on July 2, 1993. The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. The SAMHSA Centers' substance abuse and mental health services activities address issues related to Healthy People 2000 objectives of Mental Health and Mental Disorders; Alcohol and Other Drugs; Clinical Preventive Services; HIV Infection; and Surveillance and Data Systems. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0) or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone: 202-512-1800).
The Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT) and the Center for Mental Health Services (CMHS) announce the availability of FY 1999 funds for the following activities. These activities are discussed in more detail under Section 4 of this notice. This notice is not a complete description of the activities; potential applicants must obtain a copy of the Guidance for Applicants (GFA) before preparing an application. (See table.) Note: SAMHSA also published notices of available funding opportunities for FY 1999 in subsequent issues of the Federal Register. The actual amount available for awards and their allocation may vary, depending on unanticipated program requirements and the volume and quality of applications. Awards are usually made for grant periods from one to three years in duration. FY 1999 funds for activities discussed in this announcement were appropriated by the Congress under Public Law No. 105-277. SAMHSA's policies and procedures for peer review and Advisory Council review of grant and cooperative agreement applications were published in the Federal Register (Vol. 58, No. 126) on July 2, 1993. The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. The SAMHSA Centers' substance abuse and mental health services activities address issues related to Healthy People 2000 objectives of Mental Health and Mental Disorders; Alcohol and Other Drugs; Clinical Preventive Services; HIV Infection; and Surveillance and Data Systems. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0) or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone: 202-512-1800).
Taking stock of accomplishments in the field of population reveals that significant progress has been made since the late 1960s but that much remains to be done. Important challenges in population for 1990 and beyond include the implementation of more effective family planning programs, greater accessibility to better family planning services at the local level, a wider range of choices in contraceptive methods, and better training and supervision of family planning delivery personnel. Another major challenge is to give attention to the various aspects of the role of women--beyond mere acknowledgement and to the actual implementation of programs. Further, policies need to be formulated and implemented across several sectors to deal with the complex interaction between population, resources, and the environment. To devise such policies, knowledge of the interrelationships needs to be clarified and refined. Finally, still greater emphasis will have to be placed on improving the integration of population and development. Accomplishing that will require wider awareness, enhanced coordination and adequate resources--an increase of at least $100 million per year from now to the end of the century over the annual current level of some $550 million for all external assistance for population.
A total of 211 patients were entered into a randomized, double-blind study of postoperative infection in which an antibiotic (cephalothin) and a placebo were used. The antibiotic was effective in reducing sleep wound infections (p less than 0.05) and superficial wound infections (p less than 0.01). The incidence of pulmonary infections was decreased, but the change was not statistically significant, and the incidence of empyema was unaffected.
Many administrative jurisdictions have authority over parts of the Great Lakes, sometimes with competing purposes as well as governance at differing scales of time and space. As demand increases for high quality information that is relevant to environmental managers, environmental and natural resource agencies with limited budgets must look to interdisciplinary, collaborative approaches for the collection, analysis and reporting of data. The State of the Lakes Ecosystem Conferences (SOLEC) were begun in 1994 in response to reporting requirements of the Great Lakes Water Quality Agreement between Canada and the U.S. The biennial conferences provide independent, science-based reporting on the state of health of the Great Lakes ecosystem components. A suite of indicators necessary and sufficient to assess Great Lakes ecosystem status was introduced in 1998. and assessments based on a subset of the indicators were presented in 2000. Because SOLEC is a multi-agency, multi-jurisdictional reporting venue, the SOLEC indicators require acceptance by a broad spectrum of stakeholders in the Great Lakes basin. The SOLEC indicators list is expected to provide the basis for government agencies and other organizations to collaborate more effectively and to allocate resources to data collection, evaluation and reporting on the state of the Great Lakes basin ecosystem.
There is evidence from theoretical models and experimental studies that indicates that preoperative timing of chemotherapy (neoadjuvant treatment) may be a superior treatment strategy than its use postoperatively. We have shown in our pilot study of 43 premenopausal patients with newly diagnosed cancer of the breast that administration of one cycle of CMF chemotherapy preoperatively was safe. Subsequently, a randomized study of preoperative against postoperative adjuvant chemotherapy has been started and to the present time, 98 patients have been randomized. Preliminary assessment of the randomized study confirmed the safety of the adjuvant chemotherapy with one course of cyclophosphamide, methotrexate, and 5-fluorouracil given preoperatively and also showed that the interval between diagnosis and the first course of chemotherapy can be substantially reduced. In addition to the preoperative timing, other aspects of the neoadjuvant approach are discussed. They include a more frequent utilization of fine needle aspiration so that the tissue diagnosis of breast cancer can be obtained and also refinement of diagnostic techniques, used before the preoperative treatment for the selection of high-risk patients (the neoadjuvant staging). The purpose of our presentation is not to recommend presently preoperative chemotherapy routinely but rather to indicate a need for well-controlled studies testing its appealing theoretical rationale. Its use in adjuvant therapy of breast cancer represents a major departure from the conventional management and, therefore, if the cooperation of practitioners and cooperative groups is to be secured, its rationale and safety must be well-defined.
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We have compared, in a double-blind study, the efficacy of flumazenil with that of aminophylline in antagonizing the effects of midazolam in 60 patients (ASA I-II, mean age 66 yr) undergoing transurethral resection of prostate under spinal anaesthesia. All patients received midazolam 0.075 mg kg-1 i.v. and the test drugs were given 5 min after its administration. Patients were allocated randomly to receive i.v. flumazenil 0.01 mg kg-1, aminophylline 2 mg kg-1 or placebo saline 0.1 ml kg-1. One minute after administration, aminophylline caused 42% reversal of sedation, 66% of disorientation and 73% of lack of co-operation in comparison with placebo, although there was marked individual variation. Flumazenil caused complete and rapid antagonism of sedation, disorientation and lack of cooperation.
The Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Mental Health Services (CMHS) announces the availability of FY 1999 funds for the following activity. This activity is discussed in more detail under Section 4 of this notice. This notice is not a complete description of the activity; potential applicants must obtain a copy of the Guidance for Applicants (GFA) before preparing an application. (See table.) Note: SAMHSA also published notices of available funding opportunities for FY 1999 in subsequent issues of the Federal Register. The actual amount available for awards and their allocation may vary, depending on unanticipated program requirements and the volume and quality of applications. Awards are usually made for grant periods from one to three years in duration. FY 1999 funds for the activity discussed in this announcement were appropriated by the Congress under Public Law no. 105-277. SAMHSA's policies and procedures for peer review and Advisory Council review of grant and cooperative agreement applications were published in the Federal Register (Vol. 58, No. 126) on July 2, 1993. The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. The SAMHSA Centers' substance abuse and mental health services activities address issues related to Healthy People 2000 objectives of Mental Health and Mental Disorders; Alcohol and Other Drugs; Clinical Preventive Services; HIV Infection; and Surveillance and Data Systems. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0) or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone: 202-512-1800).
Swiss trade unions have long ago recognized occupation health problems. They have cooperated in many attempts to improve the health of the working population. Difficulties in promoting occupational health are partly due to the specific Swiss situation--relatively good health status of the Swiss working population but an occupational medicine rather weak in number and prestige--and the over-emphasis of the economic aspects of work. Rapidly developing technologies make the calculation of risk and the proper allocation of causes more and more difficult. Trade unions have an important role to play as an active partner in the development of occupational health. They stand for independence of occupational physicians and the participation in planning and deciding working conditions. The Swiss trade unions thereby do not merely aim at the elimination or limitation of the risks to health but also at working conditions that permit the full development of the human personality.
The acute toxic class method (ATC method) is an alternative to the LD50 test, with the use of substantially fewer animals needed for the classification of substances. Like the classical LD50 test the biometry of the ATC method is based on the probit model. The biometric calculations of the ATC method were carried out not only for the classification categories of the European Union but also for the classification criteria of various countries and organizations, currently in use. It is demonstrated that in comparison with the LD50 test in general the same classification is obtained with the ATC method and with the use of substantially fewer animals. Substances with high slopes are likely to be allocated to the predicted toxicity class in comparison with substances having low slopes, with both the ATC method and the LD50 test. Substances are more likely to be allocated into a lower toxicity class with the LD50 test than with the ATC method.
The National Cooperative Gallstone Study (NCGS) was a cooperative, randomized, controlled trial of a drug, chenodiol, for the medical dissolution of gallstones. The design and procedures of the NCGS were complex, having developed as a result of extensive involvement of many experts in the field of gallstone disease and biliary lipids. During the design and implementation of the protocol, many important issues required consideration and resolution. The aim of this article is to review these issues and the deliberations surrounding their resolution and provide personal conclusions and recommendations that may be helpful to other investigators involved in cooperative, controlled trials.