Standardization, self-regulation, and acceptance programs for dental materials and devices.
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Since 1930, the Council on Dental Therapeutics of the American Dental Association has been evaluating dental drug products for safety and efficacy through its Acceptance Program. To date, numerous products have been evaluated, and many hundreds have received the council's seal of acceptance. Acceptance criteria are rigorous, and the council relies on expert consultants to evaluate the supporting data. There are no manufacturer fees involved with the Acceptance Program. When a product has been awarded the seal, it means that adequate data have been submitted, and that the product is safe and does what it says it will do. This paper describes, in detail, how the Acceptance Program works.
Most overseas trained doctors wishing to practise in Australia are required to sit for examinations set by the Australian Medical Council (AMC) before they can seek registration through State medical boards. In 1989, the South Western Sydney Area Health Service, which is responsible for the delivery of health services to 650,000 people, initiated a bridging program with the joint aim of providing overseas trained doctors with the opportunity to undertake a comprehensive program of study and facilitating the recruitment of doctors into the area. The program comprises two integrated components, each extending over five months. Stage 1 relates to the AMC's multiple choice questionnaire (MCQ) examination; stage 2 prepares candidates for the clinical examination. In addition, provision is made for developing awareness of professional responsibility, standards and ethical bases for the practice of medicine in Australia. Participants are also required to study English and communication skills throughout the program. Acceptance into the program is based on a number of criteria including successful completion of a screening test and an interview. Progression to the Clinical Course requires that candidates pass the MCQ Course and undertake to work in the area. The program has been funded jointly by State and Commonwealth Government bodies. Results obtained by program participants in the MCQ and clinical examinations conducted by the AMC have been well ahead of the national average.
Information on the long-term clinical performance of composite resins in posterior restorations is still very limited. The council has classified some composite resins as "provisionally acceptable" for permanent teeth on the basis of information submitted under the guidelines for the acceptance program for composite resins for occlusal Class I and Class II restorations. This classification, however, does not imply their unlimited use as routine restorative material in stress-bearing areas in all situations. No justification exists to extrapolate the performance data to situations in which there are limited documented results. Also no justification exists to extrapolate the performance of one composite resin to other composite resins. The guidelines of the acceptance program were established on the basis of information available in 1981. Information is emerging that suggests that these limits do not necessarily provide a critical evaluation of the long-term performance of composite resins in posterior restorations. The guidelines are being reviewed and revised. The profession is advised to be cautious in the manipulation and application of composite resins as they are sensitive to technique. A composite resin should not be handled like an amalgam. Slight deviations from the proper technique may result in postoperative sensitivity, secondary caries, and clinical performances different from those reported in clinical studies. The cavity preparation should be conservative, and the restoration should be subjected to minimal occlusal stresses. The use of a rubber dam is essential. The profession should be aware that composite resins do have occlusal wear. Proximal contacts are difficult to establish.(ABSTRACT TRUNCATED AT 250 WORDS)
A review of the comparative characteristics and properties of noble metal alloys used for metal-ceramic restorations has been presented. Selection of an alloy for one's practice should be based on long-term clinical data, physical properties, esthetic potential, and laboratory data on metal-ceramic bond strength and thermal compatibility with commercial dental porcelains. Although gold-based alloys, such as the Au-Pt-Pd, Au-Pd-Ag, and Au-Pd classes, may appear to be costly compared with the palladium-based alloys, they have clearly established their clinical integrity and acceptability over an extended period of time. Other than the relatively low sag resistance of the high gold-low silver content alloys and the potential thermal incompatibility with some commercial porcelain products, few clinical failures have been observed. The palladium-based alloys are less costly than the gold-based alloys. Palladium-silver alloys require extra precautions to minimize porcelain discoloration. Palladium-copper and palladium-cobalt alloys may also cause porcelain discoloration, as copper and cobalt are used as colorants in glasses. The palladium-cobalt alloys are least susceptible to high-temperature creep compared with all classes of noble metals. Nevertheless, insufficient clinical data exist to advocate the general use of the palladium-copper and palladium-cobalt alloys at the present time. One should base the selection and use of these alloys in part on their ability to meet the requirements of the ADA Acceptance Program. A list of acceptable or provisionally acceptable alloys is available from the American Dental Association and is published annually in the Journal of the American Dental Association. Dentists have the legal and ethical responsibility for selection of alloys used for cast restorations. This responsibility should not be delegated to the dental laboratory technician. It is advisable to discuss the criteria for selection of an alloy with the technician and the thermal manufacturer or supplier. Once an alloy is selected, the specific alloy name should be written on all laboratory prescriptions as well as in patients' charts. Maintenance of accurate dental records is necessary from a legal point of view, and it also allows the clinician to determine the longevity of specific metal-porcelain systems.
Despite a considerable success in control smallpox in a number of countries reached as a result of vaccination the problem of eradication of this infection could not be solved without uniting the efforts of all the countries in the world. Guided by humanity principles the delegation of the USSR suggested in 1958 a program of smallpox eradication in the whole world. World smallpox morbidity is analyzed in this work.
Medical anthropologists have long been involved in health-program evaluation and have studied factors related to program acceptance in target communities. However, assessing the reasons for the success or failure of a program should not be an end in itself, but should be a process that generates guidelines for the development of similar programs elsewhere and more general suggestions about the appropriate roles that applied anthropologists can fulfill. This paper briefly summarizes the research of an anthropological team who investigated the apparent failure of a respite home facility for retarded children in a suburban neighborhood to generate requisite community support. The team was able to develop a series of recommendations in aid of a plan to establish such centers elsewhere in the county, and in the state of Florida as a whole. However, the paper is more broadly concerned with applied anthropological attempts to define the nature of target or client communities and at delineating the appropriate anthropological perspective on health care delivery transactions. New roles for the anthropologist as evaluator will be considered.
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A computer program for phenytoin (PHT) dosing was developed containing seven different menus: two for drug-naive patients, one using an empirical equation, the other using means for Vmax and Km; two for patients in whom either one or two dose rates and steady-state concentrations are available; two for patients with hypoalbuminemia, and uremia, respectively; and one menu that optimizes Vmax and Km from available steady-state concentrations. The program accepts or converts PHT and sodium PHT, and makes blood level correction for the concomitant administration of 25 different drugs. The evaluation of the program was done by retrospective analysis using data from three study pools: group I involved 47 patients from the University Hospital, group II relied upon 29 patient data supplied from a collaborative Veterans Administration study, and group III involved 26 patients from the Children's Hospital. Predictions were made and compared with found data to be within a range of +/- 15, 20, or 25%. For study group III, many individual blood samples were less than 8 micrograms ml-1; hence, saturation kinetics may not have been involved. It is suspected that saturation kinetics in infants may begin at higher levels. Compliance seems to still be a major problem in PHT monitoring and dosage regimen adjustment. Accepting the data as they are, using one or two dose rates with the corresponding blood concentrations resulted overall in 73-86% achieving blood levels within +/- 25% of the predicted value.
Current and former workers who have been occupationally exposed to hazardous substances have unique medical and social needs. Few programs recognize and accommodate the needs of these workers. Consequently, screening and medical surveillance assume a pivotal role in a system that inadequately deals with the needs of workers identified and notified of occupational disease risks. In some cases, screening programs, ineffective in altering survival patterns, are established because they represent surrogates for other kinds of support programs that do not exist. Where screening techniques are effective and available, there still are problems in getting them funded and established in acceptable programs. This paper details these problems and argues for increased research to enhance the efficacy of screening, not only in preventing disease, but also in improving the quality of life for workers at risk.
In the fall of 1986, the Ministry of Health of the province of Ontario, Canada, implemented a special 36-week internship preparation program for graduates of foreign medical schools. The program accepts 24 candidates per year and is offered at the five Ontario medical schools. At the time of this study, two cohorts of participants had completed the program. As part of the evaluation process, each participant was administered a battery of the same Objective Structured Clinical Examination-type test stations, prior to and on completion of the pre-internship experience. Repeating the same examination permitted investigation of the predictive and construct validities of the clinical skills tests, as well as the stability of the validity and high reliability estimates that emerged from the testing of the first cohort. The results provide convincing evidence of the testing approach's predictive and construct validity and reliability.
A method used by interns and supervisors in developing and evaluating a clinical performance program during a 6-week internship in the Division of Physical Therapy at the University of Michigan Medical Center is presented. This method required a statement of educational resources available, establishment of criteria for judging acceptable performance, statement by the intern of his educational objectives, negotiation of a written contract, and maintenance of a log. The 32 participants thought that this was a rational and acceptable program and stated that they would, if given a choice, elect to follow the same procedure again.
To study the clinical characteristics of ovarian endodermal sinus tumor, 22 patients with this disease who were managed at the Kurume University Hospital from 1970 to 1983 are analysed retrospectively. Before 1977 the patients received mainly radiation therapy as a postoperative treatment, and only two of 13 patients during this period survived. After 1978, multi-drug combination chemotherapy brought a remarkable improvement in the prognosis showing six survival cases out of 8 patients, and four of them are still alive with no evidence of the disease. Although the therapeutic efficacy of the combination of vincristine, actinomycin D and cyclophosphamide, or cis-diamminedichloroplatinum, vinblastine and bleomycin was evident as previously reported, half of the cases achieved a drug-resistance against these regimens during the first line therapy and this required a change in the program. Further, two drop out cases caused by the severe side effects of these aggressive treatment were noted. The best treatment for malignant germ cell tumors is not yet known, and a more effective and acceptable program is demanded to attain the goal of chemotherapy.
MacPROT is a set of seven interactive application programs and a coordinating menu for storing, editing, and analysing protein sequences. Analyses for hydropathy, amphilicity, helix wheel, and dot matrix comparison are plotted as graphs on the screen and can be printed immediately or transferred to a picture accepting program. Programs are written in BASIC for the Apple 512 kbyte Macintosh. The source code is accessible and can be adapted to other machines.
Scores on three subtests of the Minnesota Follow-up Scale (MFS) were related to client outcomes in a prevocational training program in a study of 26 clients who were referred from an adult psychiatric day treatment unit. The results of the study agreed with a prediction that successful performance in occupational therapy in the day treatment unit, as measured by subtest 1, would be significantly related to successful client outcomes. the results regarding predictions for two other subtests were less conclusive because clients received high scores. Age and sex distributions showed that the younger male clients were most likely to be referred for prevocational training. The staff of the prevocational training program accepted the results of the study and also agreed that performance in occupational therapy (in the day treatment unit) should receive greater recognition by staff members as an important indicator of work potential when evaluating clients for referral to a vocational training program. It is planned to continue the use of the MFS in the day treatment unit as an aid for evaluating clients for referral purposes. Scores will continue to be related to client outcomes in the prevocational training program. Further study is also planned concerning the relationship of age and sex and sources to which clients are discharged or referred from the day treatment unit.
Data collection for transplantable solid tumors has been automated with electronic digital calipers and a balance which have been coupled through an RS-232 interface to a microcomputer. BASIC programs handle data entry, calculations and data storage. A "PROTOCOL" program accepts keyboard input of sample name, notebook number, submitter and dose along with necessary information on tumor system, and then initial animal weights for treatment groups are sent from balance to computer. Data is stored as an ASCII file on floppy disks, and protocol reports are printed. When the test is to be measured, a "MEASURE" program prompts the user for keyboard entry of toxic deaths in each group. Then the computer requests input of width and length of tumors for each animal. These tumor dimensions are sent to microcomputer by pressing a button on the calipers. When a group is completed, final animal weights are sent from balance to microcomputer. Then tumor weights and percent inhibition as compared to appropriate control groups are calculated, and the data is appended to the file for that test. A hard copy is generated as tumors are measured, and reports including percent inhibition can be printed immediately after a test is measured. The data as an ASCII file is transferred via modem to mainframe computer, where another program transfers the information to a database management program. These automated procedures for tumor measurement save time and lessen the chance for error by eliminating manual recording of solid tumor dimensions and subsequent reentry of this data for calculation.
Community awareness of child abuse and neglect has greatly increased. The documentation of an upward trend in the number of reported and confirmed child abuse and neglect cases in Hawaii reflects the need for additional programs to respond to this growing concern. Clinical nurse specialists in psychiatric and mental health nursing have developed an intensive home-based crisis interaction and family education program, Family Crisis Care. The program accepts only families referred by Child Protective Services in which at least one child is in imminent danger of being placed in foster, group, or institutional care. The goal of Family Crisis is to prevent the out-of-home placement of children through intensive, in-home intervention and to teach families new problem-solving skills to prevent future crises. The program has been effective in maintaining the child within the home, reducing physical punishment and other problem factors in the family, improving communication and problem-solving skills, and increasing use of community resources.