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Evaluation of live attenuated influenza vaccines in children 6-18 months of age: safety, immunogenicity, and efficacy. National Institute of Allergy and Infectious Diseases, Vaccine and Treatment Evaluation Program and the Wyeth-Ayerst ca Influenza Vaccine Investigators Group.

Live attenuated, cold-adapted (ca) monovalent and bivalent influenza A vaccines were evaluated in seronegative infants (ages 6-18 months) in a double-blind placebo-controlled trial to assess safety and immunogenicity. A total of 182 seronegative subjects received a single intranasal dose (10(6.2) TCID50) of ca A/Kawasaki/9/86 (H1N1) or ca A/Los Angeles/2/87 (H3N2), both as a bivalent vaccine, or placebo. Respiratory and systemic symptoms did not differ between groups after vaccination. Hemagglutination antibody seroconversions (> or = 1:8) to H3N2 exceeded 90%. In contrast, seroconversions to A/Kawasaki/9/86 (H1N1) were significantly less frequent in bivalent ca vaccine recipients (31%) than in monovalent ca H1N1 recipients (83%) (P < .002). During a subsequent H3N2 epidemic, nasal washes were cultured for viruses from any subject with respiratory illness. H3N2 infections documented by virus isolation were reduced by 65% in ca H3N2 recipients compared with placebo or ca HIM recipients (P = .01).

Adaptation, Physiological↗

Background and framework for ILSI's collaborative evaluation program on alternative models for carcinogenicity assessment. International Life Sciences Institute.

The willingness of the agencies involved in the regulation of pharmaceuticals to accept data from newly proposed models for carcinogenicity testing (eg, transgenic animals, neonatal rodent models, initiation-promotion models) has stimulated international interest in gaining experience and a greater understanding of the strengths and limitations of the specific models. Over a 4-year period, the International Life Sciences Institute (ILSI) Health and Environmental Science Institute (HESI) has coordinated a large-scale collaborative research program to help to better characterize the responsiveness of several models proposed for use in carcinogenicity assessment. The overall objective of this partnership among industry, government, and academic scientists was to evaluate the ability of these new models to provide useful information for human cancer risk assessment. This research program reflected a commitment of nearly US$35 million by over 50 industrial, govemment, and academic laboratories from the United States, Europe, and Japan. Evaluation of the models required the development of standardized protocols to allow reproducibility and comparability of data obtained across multiple laboratories. Test compounds were selected on the basis of mechanistically meaningful carcinogenic activity or noncarcinogenicity in the rodent bioassay as well as humans. Criteria were established for dose selection, pathology review, quality control, and for evaluation of study outcome. The database from these studies represents an important contribution to the future application of new models for human cancer risk assessment. Beyond the data, the collaborative process by which the models were evaluated may also represent a prototype for assessing new methods in the future.

Academies and Institutes↗

[How external quality evaluation programs affect the quality of laboratory results in routine practice in the Czech Republic].

Goals of our study were: 1. to assess quality of our analytical work and application of concepts of good laboratory practice using different EQA surveys, 2. to evaluate performance and efficiency of systems for internal quality control using EQA program that is independent on local subjective and objective influences and 3. to observe how single EQA programs differ and how they contribute the ability of laboratories to manage their overall quality. Using one-way ANOVA, we compared our 1999 results in the local EQA survey AKS (SEKK s r.o., Czech Republic) to our results in CN3 Comprehensive Chemistry Survey (College of American Pathologists, USA) for analyses provided in CN3 with the definitive method correlated target values, the design of which assures accuracy of the field methods on patient specimens. In 4 out of 9 methods, the material AKS predicted target values that were significantly different from that of CN3; calcium sodium, uric acid and cholesterol. The CN3 survey provided link of our results of internal quality control and national EQA to the largest proficiency testing available worldwide in clinical chemistry. Out data suggest that a possibility exists to improve the design of target values for materials used for small national EQA surveys as well as the program administration so that local characteristics of field method on patient specimens could be better monitored.

Clinical Chemistry Tests↗

Targeting dental sealants in school-based programs: evaluation of an approach.

Several guidelines have been published in the United States to promote the appropriate use of sealants in both individual care and public health programs. Targeting sealants to children and teeth at high risk for dental caries has been accepted as a desirable strategy in school-based programs. However, there is little evidence to show that programs are complying with these guidelines. This report examined the extent to which sealants were targeted to high-risk children at 11 different school-based programs in New York State. Data on 3357 children ages seven to nine were analyzed. The percent of children receiving sealants ranged from 41% to 88%. While in two sites (St. Lawrence & Onondaga) fewer than 52% of the children received sealants; more than 73% received sealants in the remaining nine sites (P < 0.05). The results suggest that there was a wide variation in the implementation of the guidelines for sealant use. Some reasons for not adhering to the guidelines were: difficulty in assuring parents and local dentists that some children were not at risk for caries; lack of confidence in the risk-assessment method; uncertainty regarding what constitutes deep pits and fissures; fear of misclassifying children and requests by school administrators, parents and local dentists that all children should benefit from preventive measures.

Chi-Square Distribution↗

COMPARE/Radiology, an interactive Web-based radiology teaching program evaluation of user response.

RATIONALE AND OBJECTIVES: The aim of this study is to assess user benefits of COMPARE/Radiology, a highly interactive World Wide Web-based training program for radiology, as perceived by its users. MATERIALS AND METHODS: COMPARE/Radiology (http://www.idr.med.uni-erlangen.de/compare.htm), an interactive training program based on 244 teaching cases, was created by the authors and made publicly available on the Internet. An anonymous survey was conducted among users to investigate the composition of the program's user base and assess the acceptance of the training program. In parallel, Web access data were collected and analyzed using descriptive statistics. RESULTS: The group of responding users (n = 1370) consisted of 201 preclinical medical students (14.7%), 314 clinical medical students (22.9%), 359 residents in radiology (26.2%), and 205 users of other professions (14.9%). A majority of respondents (1230; 89%) rated the interactivity of COMPARE/Radiology as good or excellent. Many respondents use COMPARE/Radiology for self-study (971; 70%) and for teaching others (600; 43%). Web access statistics show an increase in number of site visits from 1248 in December 2002 to 4651 in April 2004. CONCLUSION: Users appreciate the benefits of COMPARE/Radiology. The interactive instructional design was rated positively by responding users. The popularity of the site is growing, evidenced by the number of network accesses during the observation period.

Computer-Assisted Instruction↗

Response of general practitioners to a national dental office evaluation program. Office of Quality Assurance.

The methods used and the results achieved in an effort to solicit 300 volunteers to test the feasibility of a dental office assessment instrument have been described. In response to personal letters to general practitioners in 14 states, 13.9% returned a card indicating a willingness to consider participation. The response rate from different states ranged from 8% to 21.7% with the response being more favorable from states with fewer dentists. Year of graduation from dental school had little effect on the rate of response. Rural dentists responded at a slightly more favorable rate. Of dentists responding, 71% did so within 2 weeks and 90% within the first month after receiving the solicitation. Mail solicitation can be used successfully in recruiting private practitioners for participation in an in-office practice assessment program.

Adult↗

[A conceptual framework for the evaluation of health programs].

Evaluation can have three distinct goals: to help plan and develop programs, to provide information which will improve programs and to determine the outcomes and impact of programs. Evaluation questions flow from each of these goals. Described in this paper are different types of evaluation useful in answering these questions. Whatever type of evaluation is chosen, the evaluator must attempt to assess its validity. This validity concerns the equivalence between answers to evaluation questions and the "true value" of the program. It is just as concerned with measurement strategy and instruments as it is with the designs and techniques of analysis used, and the population studied.

Evaluation Studies as Topic↗

Children's self-selection into prevention programs: evaluation of an innovative recruitment strategy for children of alcoholics.

Systematically evaluated the efficacy of a self-selection strategy to recruit elementary-aged children into a school-based prevention program for children of alcoholics. Recruitment involved: a film about parental alcoholism, a follow-up meeting, and an invitation to participate in a prevention program. Of the 844 4th-6th graders exposed to recruitment, 67% showed no interest in the program, 26% attended the follow-up meeting, and 11% obtained parental permission. Analyses focused on group differences according to selection classification on measures of symptomatology and resources available to the child. Significant differences were noted on level of concern about parents' drinking, depression, conduct disorder, and self-worth. Children interested in the program tended to score higher on measures of symptomatology. The potential of a self-selection model for identifying children at risk and areas for future research are discussed.

Alcohol Drinking↗

The Challenge Project: a treatment program evaluation for perpetrators of child sexual abuse.

OBJECTIVE: Research on treatment outcome for sex offenders has been poorly designed, with biased sampling, lack of controls, and a failure to define treatment programs, subjects, and outcome measures. This research aimed to compare group and individual treatment outcomes, with particular reference to program compliance and reoffending. METHOD: The Challenge Project assessed all 80 convicted perpetrators of child sexual abuse in S.E. London over a 2-year period, and followed them up 1 and 2 years later. The 43 perpetrators who were diverted into the community program received weekly standardized cognitive-behavioral treatment over a 1-year period. Subjects were matched on key variables and entered either group or individual therapy. RESULTS: Some treatment effects could be demonstrated in both group and individual therapy, particularly if individual changes in test scores were examined. Two variables were significantly associated with poor treatment compliance: A history of sexual and/or violent offending, and a history of childhood sexual victimization. However, only one subject had been convicted of a further sexual offense--possession of child pornography--at follow-up. CONCLUSION: The findings may support professionals in deciding how best to allocate scarce resources; and it is intended to extend the outcome study to at least a 5-year follow-up period, to see whether compliance and shifts in psychological measures are a valid predictor of outcome.

Adult↗

Clinicians, the Mount Sinai program and the Veterans' Administration program evaluated against clinico-pathological data derived independently of the electrocardiogram.

221 electrocardiograms (ECGs) recorded from adult subjects with cardiac symptomatology were interpreted by clinicians and the Mount Sinai (MS) and Veterans' Administration (VA) computer programs. After the clinicians had eliminated their interobserver variability, their interpretations and those of the computer programs were compared with the corresponding clinico-pathological data that had been derived independently of the ECG. A measure of overall diagnostic accuracy was used which showed that the performance of the 2 computer programs was similar and somewhat worse than that of the clinicians. The clinicians and the computer programs were not as good at diagnosing the ECGs of women as at diagnosing those of men. As the VA program's interpretations may be altered by including information about the patient's provisional diagnosis, 6 different sets of these prior probabilities were used to analyse 141 of the original 221 ECGs. Different fixed sets of prior probabilities made only a small difference to overall diagnostic accuracy but a marked difference to the VA program's ability to differentiate Normal from Abnormal. Optimizing the prior probabilities for the individual subjects increased the VA program's overall diagnostic accuracy up to that of the clinicians. Both computer programs correctly diagnosed sinus rhythm as the dominant rhythm in 165 out of 177 subjects. The MS program diagnosed the dominant rhythm as Atrial Fibrillation in 35 out of 41 subjects and the VA program in 27 (X(2) = 3.24; not significant). ECG interpretation; Mount Sinai program; Veterans' Administration program; independent clinico-pathological data; sex differences in the ECG; prior probabilities.

Adult↗

Client participation in CMHC program evaluation: increasing incidence, inadequate involvement.

Client satisfaction surveys and client complaint systems are used by more CMHCs since the Amendments of 1975 required centers to evaluate "acceptability of service," but clients are seldom actively involved in designing or administering these evaluations. The authors argue that greater control by clients is merited on technical and political grounds, and would increase the likelihood that program improvements would result from assessments of acceptability.

Community Mental Health Centers↗

Cost savings for a preferred provider organization population with multi-condition disease management: evaluating program impact using predictive modeling with a control group.

Disease management programs have historically had difficulty demonstrating the financial value of their programs using statistically rigorous methods. This preliminary study utilized a predictive model built from a control group that consisted of individual employer groups whose benefits managers did not purchase disease management. The purpose of this evaluation was to examine the cost savings associated with Health Management Corporation's disease management program for asthma, diabetes, and coronary artery disease. Study and control group members were identified with exactly the same selection criteria as self-insured employer groups (n = 76,194) with preferred provider organization health plans that offered the disease management program. The study group consisted of members (n = 1,009) who were identified as having any of the three conditions and were eligible for the disease management program, regardless of the extent of their participation. The control group included members (n = 2,491) who were identified as having any of the same three conditions. The control group data were used to develop a predictive model designed to calculate expected medical claims costs for the study group. The gross savings of the disease management program was measured by calculating the difference between the expected medical claims costs predicted by the model and the actual medical claims costs for the study group. Preliminary analyses indicate that Health Management Corporation's disease management program produced a return on investment of $2.84: $1.00 and $1.45 gross savings per member per month.

Adolescent↗