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PubMed1998

Informal workshop on potential regulatory and 2 licensing issues for pneumococcal conjugate vaccines. 13 June 1998, Helsingor, Denmark.

(1) It is likely that a seven-valent pneumococcal conjugate vaccine will be licensed in the next few years based on efficacy studies. Licensure of nine- or 11-valent vaccines will be sought soon thereafter. Further studies of nine- or 11-valent vaccines which can evaluate efficacy of the added serotypes will be unlikely. (2) Licensure of other vaccines (including those with additional serotypes), will depend on evaluation of surrogates for efficacy. (3) The most accepted surrogate of efficacy at this point is some combination of functional assay (e.g. opsonophagocytosis), and/or serology of anticapsular antibody by ELISA or RIA that correlates closely with the functional test. (4) An additional important correlate of immunity for polysaccharide conjugate vaccines may be measurement of the booster response. (5) Although effect on nasopharyngeal carriage may be developed into a useful correlate of efficacy in the future, much additional work must be done before carriage data can be interpreted usefully for this purpose. (6) Testing for consistency of production of pneumococcal conjugate vaccines will follow lines similar to that for Hib conjugate vaccines. Thus, instead of one set of universally applicable lot release criteria, vaccine-specific criteria must be developed collaboratively between industry and national control authorities.

Bacterial Vaccines↗
PubMed1999

Sport-caught fish consumption and conception delay in licensed Michigan anglers.

Between 1993 and 1995, we surveyed 4931 licensed anglers aged 17-34 years residing in 10 Michigan counties bordering a Great Lake. Responses were received from 1443 anglers and 844 of their partners. Lifetime sport-caught fish consumption was estimated as the number of sport-caught fish meals consumed in the previous 12 months times years since 1970 in which sport-caught fish were consumed. Analysis was restricted to currently married couples (n=626). Lifetime sport-caught fish consumption was categorized in men as 0 (14%); 1-114 (27%); 115-270 (30%); 271-1127 (29%) meals; and in women as 0 (28%); 1-54 (26%); 55-138 (27%); fand 139-1127 (19%) meals, respectively. Conception delay (ever having failed to conceive after 12 months of trying) was reported by 13% of both men and women. Among men, the unadjusted odds ratios (OR) for conception delay were 1.2, 1.3, and 2.0 across the three increasing levels of sport-caught fish consumption compared to none (trend test P=0.06). After adjustment for age, race, region of Michigan, household income, educational attainment, smoking, alcohol consumption, and partner's sport fish consumption, the OR for conception delay in men were 1.4, 1.8, and 2.8, respectively. In women, unadjusted OR for conception delay were 0.9, 1.0, and 1.4 with increasing sport-caught fish consumption (trend test P=0.35). With the same covariates and the sport-caught fish consumption of the woman's partner included in the model, the OR were 0.8, 0.8, and 1.0, respectively. These data suggest a modest association, in men only, of sport-caught fish consumption with risk of conception delay.

Adolescent↗
PubMed1999

Screening mammography referral rates for women ages 50 to 69 years by recently-licensed family physicians: physician and practice environment correlates.

BACKGROUND: Physician mammography referral remains below optimal levels despite a long-standing recommendation that all women ages 50 to 69 years receive screening mammography every 1 to 2 years. The purpose of this study was to determine physician and practice environment predictors of family physicians' screening mammography referral rates to women ages 50-69 years. METHOD: A cohort of 498 recently-licensed family physicians was followed for 18-months of incipient medical practice. The referral rate was the percentage of new clinically eligible women patients seen in a primary care context who had a screening mammogram ordered by the study physician. Mammograms and independent variables were identified from physician claims to a Canadian universal health insurance agency. The effects of factors in a conceptual framework were assessed using multivariable linear regression. RESULTS: Correlates of higher mammography referral rates were female gender, better general prevention knowledge, the combination of comprehensive inquiry and continuity care, lower patient volume, and lower shared primary care (multivariable model R(2) = 0.47). Factors belonging to practice environment explained more of the observed variance than did physician characteristics. CONCLUSIONS: Mammography referral varies enormously and almost half of the variance is explained by physician characteristics and practice preferences. Higher mammography referral is observed in practices with more comprehensive and continuity care.

Adult↗
PubMed1996

DNA replication licensing factor.

DNA Replication Licensing Factor (RLF) is an essential activity required to restrict the duplication of genomic DNA to precisely once per cell cycle. Recent fractionation of RLF activity from Xenopus egg extracts has resulted in the identification of two essential components, RLF-B and RLF-M. RLF-M has been purified to homogeneity and has been shown to consist of a complex of proteins in the MCM/P1 family. RLF-B is still unidentified, but possible candidates for this activity have been identified in yeast. Elucidation of the RLF mechanism will provide important insights into the way that chromosome replication is controlled.

Animals↗
PubMed1996

Hypothesis: how licensed vaccines confer protective immunity.

By examining experience with evaluation of licensed vaccines we theorize that a critical level of serum IgG confers protection against infectious diseases by killing or inactivating the inoculum. We found that efficacy is reliably predicted by measurement of serum antibodies elicited by vaccines, that serum IgG antibodies alone account for the protection conferred by passive immunization, that vaccine-induced "herd" immunity is best explained by inactivation of the inoculum on epithelial surfaces by serum antibodies and that serum antibodies induced by active immunization will neither treat disease symptoms nor eliminate the pathogen. If valid, this theory should facilitate research because knowledge of the pathogenesis of the disease symptoms may not be essential for vaccine development.

Animals↗
PubMed1991

[Use-risk consideration of anti-infective agents from the point of view of the licensing authority].

The present standard requirements for the clinical evaluation of anti-infective drugs are so high that in most cases strong evidence for the benefit of a new medicine can be provided. Therefore risk estimation is much more emphasized than proof of efficacy during the review process performed by the regulatory authority. The total number of patients treated with an investigational drug before an application is made for a product licence varies between 2,000 and 4,000; in rare instances up to 9,000 patients are evaluable. It is obvious that adverse effects with incidences of 0.5% cannot be detected during clinical investigation, even with such a great number of patients. The risk estimation of a new anti-infective drug is based on results from the following sources: toxicity studies in animals, studies on general pharmacology (preclinical and clinical), clinical studies on safety and efficacy, finger-print of adverse reactions of new compounds belonging to approved chemical classes, experience in other countries, and monitoring of safety after licensing. As many drugs share chemical or pharmacological characteristics with approved drugs, the pattern of adverse effects can be anticipated. When reviewing a new anti-infective agent not belonging to an approved chemical class, there remains more uncertainty. In the case of infections for which current treatment exists, the possible risks which can be accepted for a new compound cannot be higher than that of the alternatives. If no alternatives exist, in certain cases high risks can be accepted, especially when a potentially life-saving or life-prolonging drug is being evaluated. Among the adverse effects which cannot be anticipated are: hypersensitivity, ocular toxicity and CNS reactions.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1997

Reducing governmental interventions in families by licensing parents.

Government has played an increasing role in family life because too many parents have not fulfilled their childrearing responsibilities. The misuse of parental power in child abuse and the abdication of parental responsibilities in child neglect have necessitated governmental interventions in order to protect children. A parent license would validate parental rights, establish parental responsibility, and provide a basis for the societal support of parenting in the form of financial benefits, parent education and training, and protective services for children when necessary. By generally increasing competent parenting, it would substantially reduce the need for governmental interventions in families.

Child↗
PubMed2002

Evaluation of risk of Parkinson's disease in a cohort of licensed pesticide users.

In the last two years, the environmental theory on the aetiology of Parkinson disease has acquired new data. From an experimental point of view, a new model of parkinsonism induced by rotenone, a diffuse insecticide, has been proposed, and in vitro studies have provided proof that several pesticides stimulate the formation of alpha-synuclein fibrils (one of the principal constituents of Lewy bodies). Moreover, a meta-analysis of all case-control studies so far performed showed a positive, statistically significant association between pesticide exposure and PD. In this context, we are performing a cohort study on 5575 licensed pesticide users in the province of Viterbo. After 27 years of follow-up, 4788 subjects are still alive. The aim of this study is to measure the prevalence of Parkinson's disease in a large group of workers with theoretically increased risk.

Cohort Studies↗
PubMed1996

An evaluation of the New Zealand graduated driver licensing system.

Young drivers have a disproportionately high risk of experiencing a road traffic crash. On 1 August 1987 a Graduated Driver's Licensing System (GDLS) was introduced in New Zealand. This system was designed to give young drivers (i.e. 15-24 years inclusive) experience in driving while being excluded from high risk driving situations. We sought to determine the impact of the GDLS on serious injury crashes. The source of the injury crash data was New Zealand's Health Information Services' national public hospital inpatient morbidity data files for the years 1979-1992 inclusive. We disaggregated the occupant data into three age groups 15-19 years, 20-24 years, and persons 25 years of age or older and compared their trends in injury. In order to determine whether the incidence of motor vehicle crashes was simply following trends in other injury events we also included two 15-19 year old non-traffic injury comparison groups. Using time series analyses we showed that the introduction of the GDLS was closely followed by substantial reductions in car crash injuries for all age groups, especially 15-19 year olds (23% reduction). After considering effects for older occupants we speculate that the effect is likely to be substantially less than 23%. An analysis of licensure data suggests that the reduction in crashes may, in large part, be attributable to an overall reduction in exposure.

Accidents, Traffic↗
PubMed1996

License plate confiscation for persistent alcohol impaired drivers.

Minnesota cancels the registrations and confiscates the license plates of vehicles driven by repeat drinking drivers in a procedure which prior research has demonstrated to be effective in reducing subsequent recidivism. The research reported here concerns the problems experienced in the functioning of this law. Samples of officials and repeat driving under the influence (DUI) offenders were interviewed in Minnesota and in the neighboring state of Iowa, chosen for comparison because its laws also provide for plate confiscation, but using a judicial rather than an administrative procedure. In addition, representative samples of the driving and vehicle registration records of convicted drunk drivers and of routine traffic offenders were analyzed. The research found that evasion of plate impoundment orders by drivers, though apparently easy to accomplish, appeared to be rare. However, the orders were themselves not issued in a large proportion of cases where they were prescribed by statute, potentially weakening the effectiveness of the law. The reasons, with possible countermeasures, are explored in this report.

Adaptation, Psychological↗
PubMed1996

The role of bioassays in the development, licensing and batch control of biotherapeutics.

The role of bioassays in ensuring the safety and efficacy of medicines produced by biotechnology intended for human use is under continuous review. It is a complex area, in which the rapid scientific and technological advances have been accompanied, more or less synchronously, by novel clinical applications. The need to match the rapidity of these developments with the necessarily more cautious regulatory procedures for licensing and controlling medicines in the pharmaceutical marketplace has produced an area of active debate. This article reviews the debate and its practical consequences, while maintaining the pre-eminence of the underlying scientific values.

Biological Assay↗
PubMed1995

Sequence of mouse CDC47, a member of the minichromosome maintenance (Mcm) family involved in the DNA replication licensing system.

The cDNA encoding a mouse protein, mCDC47, belonging to the minichromosome maintenance (Mcm) family possibly involved in the DNA replication licensing system, was cloned and sequenced. Its deduced amino acid (aa) sequence contained a putative DNA-dependent ATPase motif commonly observed in the family, and a zinc-finger-like domain found in some members of the family.

Adenosine Triphosphatases↗
PubMed2005

The strength of graduated drivers license programs and fatalities among teen drivers and passengers.

OBJECTIVES: The purpose of this study is to investigate the effects of differentially stringent graduated drivers license programs on teen driver fatalities, day-time and night-time teen driver fatalities, fatalities of teen drivers with passengers present, and fatalities among teen passengers. METHODS: The study uses 1992-2002 data on motor vehicle fatalities among 15-17-year-old drivers from the Fatality Analysis Reporting System to identify the effects of "good", "fair", and "marginal" GDL programs based upon designations by the Insurance Institute for Highway Safety. Analysis is conducted using conditional negative binomial regressions with fixed effects. RESULTS: "Good" programs reduce total fatalities among young drivers by 19.4% (c.i. -33.0%, -5.9%). "Fair" programs reduce night-time young driver fatalities by 12.6% (c.i. -23.9%, -1.2%), but have no effect on day-time fatalities. "Marginal" programs had no statistically meaningful effect on driver fatalities. All three types of programs reduced teen passenger fatalities, but the effects of limitations on the number of passengers appear to have had only minimal effects in reducing fatalities among young drivers themselves. CONCLUSIONS: Stronger GDL programs are more effective than weaker programs in reducing teenage motor vehicle fatalities.

Accidents, Traffic↗
PubMed2005

Is rigorous punishment effective? A case study of lifetime license revocation in Taiwan.

This study investigated the effectiveness of administrative lifetime driver's license revocation (ALLR) and its impact on offenders, based on a two-stage survey of 768 offenders. It was found that after ALLR had been imposed, 23.4% of these offenders were still driving almost the same as before, 59.8% drove significantly less frequently, and only 16.8% of the offenders gave up driving completely. The results of logistic regression models showed that offenders' compliance with ALLR was significantly correlated with their personal characteristics (age, income), penalty status (incarceration, duration of ALLR), and the need to drive for working, commuting and shopping. Elderly and low-income offenders were more likely to abide by the ALLR restriction. The application of the generalized estimating equations (GEE) model was used to identify the determinant factors affecting offenders' driving mileage, and to effectively estimate the driving mileage reduction as a result of the ALLR. It was found that ALLR is fairly effective in keeping offenders off the road, but that it may reduce their ability to make a living, resulting in the less fortunate becoming more helpless.

Adult↗
PubMed2007

Is it feasible to include a technical skill station on a national licensing examination?

The purpose of the current study was to assess the feasibility and validity of including a technical skill station on a national licensing examination. At the 2003 Medical Council of Canada Qualifying Examination, 745 test takers participated in a pilot station assessing the ability to perform a technical procedure. Checklists and rating scales were used for scoring. Validity was investigated by comparing surgery-trained to non-surgery-trained test takers. The mean for the pilot station was 72.4%. The pilot station was moderately correlated to the rest of the examination (item-total correlation .43). The mean score for surgery test takers was higher than for other test takers (P < .001). Inclusion of a technical skill station on a high-stakes examination is feasible, and at many levels, there is evidence of the validity of including this station.

Canada↗
PubMed2005

Controlling centrosome number: licenses and blocks.

Centrosomes organize microtubule structures in animal cells. The centrosome duplicates once per cell cycle in most dividing cells via a pathway that relies on a pre-existing centrosome. The molecular mechanism of this 'once and only once' control is not understood, and recent results show that centrosomes can also be assembled by a de novo pathway that bypasses this control. These results require a rethinking of how proper centrosome number is maintained. We propose that the engagement of centrioles with each other normally blocks centrosome re-duplication, and that disengagement of centrioles from each other at the end of mitosis licenses them for duplication in the subsequent cell cycle.

Animals↗
PubMed2004

Protecting the patient by promoting end-user competence in health informatics systems-moves towards a generic health computer user "driving license".

The effectiveness and quality of health informatics systems' support to healthcare delivery are largely determined by two factors-the suitability of the system installed, and the competence of the users. However, the profile of users of large-scale clinical health systems is significantly different from the profile of end-users in other enterprises such as the finance sector, insurance, travel or retail sales. Work with a mental health provider in Ireland, who was introducing a customized electronic patient record (EPR) system, identified the strong legal and ethical importance of adequately skills for the health professionals and others, who would be the system users. The experience identified the need for a clear and comprehensive generic user qualification at a basic but robust level. The European computer driving license (ECDL) has gained wide recognition as a basic generic qualification for users of computer systems. However, health systems and data have a series of characteristics that differentiate them from other data systems. The logical conclusion was the recognition of a need for an additional domain-specific qualification-an "ECDL Health Supplement". Development of this is now being progressed.

Computer Literacy↗
PubMed2004

A comparison of wait times and patients leaving without being seen when licensed nurses versus unlicensed assistive personnel perform triage.

INTRODUCTION: In today's health care environment, nurses are sometimes substituted with unlicensed assistive personnel (UAP), despite the lack of research into the possible negative effects. This study compared the wait time and the number of patients who left without being seen (LWBS) between triage systems that use nurses (including licensed practical nurses, nurses with an associate's degree, and nurses with a baccalaureate degree) versus UAP. METHODS: This study was a comparative descriptive retrospective chart review. The sample consisted of 2 parts: Part 1 involved charts for every fifth patient presenting to the emergency department during the second shift in April 1997 (N = 323) and April 1998 (N = 281). Part 2 included the monthly number of patients who LWBS between January 1997 and April 1998. Data were collected from department-generated reports with use of investigator-designed forms. Specific time increments were calculated and compared between triage systems via 2-tailed t tests. The number of patients who LWBS was analyzed for trends. RESULTS: Wait time decreased by 73 minutes and the number of patients who LWBS decreased by 85% when nurses performed triage. DISCUSSION: Results of this study show that a triage system using nurses provided more services during triage and were associated with less wait time after triage and a decreased likelihood of patients LWBS compared with the triage system using UAP.

Emergency Nursing↗