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Women with polycystic ovary syndrome (PCOS) often undergo protracted treatment with metformin and are disinclined to stop: indications for a change in licensing arrangements?

Women with polycystic ovary syndrome (PCOS) are increasingly being treated with metformin as an insulin sensitizing agent to reduce symptoms of hyperandrogenism and promote fertility. Indications such as hirsutism and cycle regulation require long term treatment. The drug is also being used through pregnancy. It is not licensed for any indication specific to PCOS, which means that much of this prescribing is taking place in an environment short of reliable information concerning safety. We describe the failure of recruitment to a study undertaken to explore the effects of metformin treatment discontinuation in women with PCOS, to provide both clinical and aetiological information. The study failed because the patients did not wish to stop treatment, and it illustrates the problems facing doctors working in this area. To achieve a safer prescribing environment, we recommend that action be taken by the manufacturer of metformin to work with regulatory agencies on a European base to extend prescribing indications for metformin to women with PCOS.

Clinical Trials as Topic↗

Bacteriophages and endotoxin in licensed live-virus vaccines.

In confirmation of recent reports, coliphages were found in seven of 19 unselected samples of the currently licensed live-virus vaccines. Coliphages and pseudomonas phage were found in 11 and 14, respectively, of the 20 bovine sera commonly used in the cell culture phase of virus vaccine production. The same lots of vaccine and serum were examined by the limulus assay for endotoxin, another product of bacterial contamination. Eighteen of 20 sera had detectable endotoxin-like activity. Our preliminary results suggest that endotoxin activity may serve as a sensitive indicator of residual products of previous bacterial contamination, including bacteriophages.

Animals↗

Pesticide use by licensed applicators for the control of Ixodes scapularis (Acari: Ixodidae) in Connecticut.

To assess the use of insecticides for tick control by commercial applicators in Connecticut, a questionnaire was mailed to 897 individuals and businesses with ornamental and turf pesticide applicator licenses. In total, 348 completed surveys were returned (38.8%). The majority of the respondents considered themselves lawn care (41.1%), landscape (31.3%) or tree care (12.6%) providers. Tick control services were offered by 16.4% (n = 57) of the respondents, all of whom apply insecticides for tick control, mainly for Ixodes scapularis Say. Over half (n = 33) also treat for the American dog tick, Dermacentor variabilis (Say). Most respondents (66.7%) began applying pesticides for the control of I. scapularis during the period from 1990 to 1996. The principal acaricide used for tick control was cyfluthrin (n = 21), with chlorpyrifos 2nd (n = 18), carbaryl 3rd (n = 12), and fluvalinate (n = 4) 4th. When asked about what other pesticides were used for tick control, the top 3 chemicals also were the principal alternatives. Past success with a product was the dominant factor in selecting a pesticide, but information provided by the Connecticut Agricultural Experiment Station (New Haven), Cooperative Extension (University of Connecticut, Storrs), and scientific studies were important. Half of the respondents (49.1%) indicated that their tick control business had increased slightly or dramatically since 1991, although tick control comprises < 5% of their overall business for 63.1% of these applicators. Residential properties comprised 90% of the business for half of those treating for ticks, and the median charge for 0.4 ha was $180. Many respondents (43.8%) also indicated that they planned to expand their tick control services. Tick control represents a small but growing business in Connecticut.

Animals↗

A survey of semen donation: phase I--the view of UK licensed centres.

It has been suggested that the implementation of the Human Fertilisation and Embryology Act in the UK in 1991 may have had a detrimental effect on the supply of semen donors. The aim of this survey was to obtain data relating to semen donation in the UK during 1989-1992. A questionnaire designed to obtain information about the recruitment and screening of semen donors, the supply of semen donors, and use of donated semen for infertility treatment was sent to all licensed centres in April 1993 and 93% were returned for analysis. The results demonstrate that while the number of centres recruiting donors and the number of men offering to be donors have increased in recent years, this has not resulted in an increased supply of donors. Reasons for these findings are discussed in the light of the Human Fertilisation and Embryology Authority regulations relating to semen donation.

Female↗

A licensed practical nurse/licensed vocational nurse's (LPN/LVN) guide to the changing healthcare system.

The purpose of this article is to help licensed practical nurses/licensed vocational nurses (LPN/LVN) become aware of their role in the changing healthcare system. There is no better time than the present to begin thinking of how to survive in the current atmosphere of change and uncertainty. The challenge for the LPN/LVN is to define a framework for practice in the new system. A clear vision is needed for tomorrow, a personal vision that each individual must define and work toward.

Adaptation, Psychological↗

Impact of the USMLE step 1 on teaching and learning of the basic biomedical sciences. United States Medical Licensing Examination.

Medical licensure in the United States is in transition. In June 1991, the National Board of Medical Examiners (NBME) made major modifications in the content, format, pass/fail standards, and score reports of the NBME Part I examination. This year, Part I became Step 1, the first of three components of the United States Medical Licensing Examination (USMLE), which will shortly be the sole examination pathway to initial licensure for allopathic physicians. This essay describes Step 1, reviews the phase-in plans for the USMLE, and discusses the potential impact of both on medical schools' teaching and students' learning of the basic biomedical sciences. The authors recommend that medical schools (1) abandon the use of Step 1 as a sole criterion for student promotion to the third year and (2) carefully review other examination-related requirements for promotion and graduation.

Curriculum↗

Residency directors' predictions of candidates' performances on a licensing examination.

PURPOSE: To look at how well residency directors in family medicine predict the performances of their candidates on the Quebec Licensing Examination (QLEx) for family physicians. METHOD: The four family medicine program directors in Quebec were asked in the spring of 1992 to identify the ten residents from their own programs who would get the highest marks on the QLEx and the ten who would get the lowest marks. From the results of these candidates, and those of the intermediate groups defined by default, the prediction abilities of the program directors were assessed. RESULTS: Descriptive statistics showed that the program directors had difficulties discriminating among the different groups and tended to collapse the predicted scores toward the total mean. Analysis-of-variance studies confirmed the absence of difference between the predicted weak and intermediate groups as well as between the predicted intermediate and strong groups for each program and for each QLEx component. Regression analysis as well as eta 2 studies showed that the program directors' prediction abilities were low for all components and represented less than 25% of the explained variance of the QLEx scores. CONCLUSION: The residency directors did not accurately categorize their residents' performances on the QLEx. Both the evaluations of program directors and terminal examination results are complementary approaches to clinical competence assessment and should be used for licensure.

Educational Measurement↗

Review of the score-reporting policy for the United States Medical Licensing Examination.

In 1998, the authors, acting on behalf of the National Board of Medical Examiners (NBME), undertook a review of the scoring policy for the United States Medical Licensing Examination (USMLE). The main goal was to determine the likely effect of changing from numeric score reporting to reporting pass-fail status. Several groups were surveyed across the nation to learn how they felt they would be affected by such a change, and why: all 54 medical boards; 1,600 randomly selected examinees (including 250 foreign medical graduates) who had recently taken either Step 1, Step 2, or Step 3 of the USMLE; 2,000 residency directors; the deans, education deans, and student affairs deans at all 125 U.S. medical schools accredited by the Liaison Committee on Medical Education; and all 17 members of the Council of Medical Specialty Societies. Responses from the different groups surveyed varied from 80% to a little less than half. The authors describe in detail the various views of the respondents and their reasons. Some members in each group favored each of the reporting formats, but the trend was to favor numeric score reporting. The majority of the responding examinees desired that their USMLE scores be sent to them in numeric form but sent to their schools and to residency directors in pass-fail form. Based on the responses and a thorough discussion of their implications, the Composite Committee (which determines USMLE score-reporting policy) decided that there is no basis at this time for changing the current policy, but that it would review the policy in the future when necessary.

Clinical Competence↗

Assessing the underlying structure of the United States Medical Licensing Examination Step 2 test of clinical skills using confirmatory factor analysis.

BACKGROUND: The purpose of the present study was to assess the fit of three factor analytic (FA) models with a representative set of United States Medical Licensing Examination (USMLE) Step 2 Clinical Skills (CS) cases and examinees based on substantive considerations. METHOD: Checklist, patient note, communication and interpersonal skills, as well as spoken English proficiency data were collected from 387 examinees on a set of four USMLE Step 2 CS cases. The fit of skills-based, case-based, and hybrid models was assessed. RESULTS: Findings show that a skills-based model best accounted for performance on the set of four CS cases. CONCLUSION: Results of this study provide evidence to support the structural aspect of validity. The proficiency set used by examinees when performing on the Step 2 CS cases is consistent with the scoring rubric employed and the blueprint used in form assembly. These findings will be discussed in light of past research in this area.

Clinical Competence↗

A multilevel analysis of the relationships between selected examinee characteristics and United States Medical Licensing Examination Step 2 Clinical Knowledge performance: revisiting old findings and asking new questions.

BACKGROUND: This study examines: (1) the relationships between examinee characteristics and United States Medical Licensing Examination Step 2 Clinical Knowledge (CK) performance; (2) the effect of gender and examination timing (time per item) on the relationship between Steps 1 and 2 CK; and (3) the effect of school characteristics on the relationships between examinee characteristics and Step 2 CK performance. METHOD: A series of hierarchical linear models (examinees-nested-in-schools) predicting Step 2 CK scores was fit to the data set. The sample included 54,487 examinees from 114 U.S. Liaison Committee on Medical Education-accredited medical schools. RESULTS: Consistent with past examinee-level research, women generally outperformed men on Step 2 CK, and examinees who received more time per item generally outperformed examinees who received less time per item. Step 1 score was generally more strongly associated with Step 2 CK performance for men and for examinees who received less time per item. School-level characteristics (size, average Step 1 performance) influenced the relationship between Steps 1 and 2 CK. CONCLUSION: Both examinee-level and school-level characteristics are important for understanding Step 2 CK performance.

Female↗

Modeling longitudinal performances on the United States Medical Licensing Examination and the impact of sociodemographic covariates: an application of survival data analysis.

BACKGROUND: This study models time to passing United States Medical Licensing Examination (USMLE) for the computer-based testing (CBT) start-up cohort using the Cox Proportional Hazards Model. METHOD: The number of days it took to pass Step 3 was treated as the dependent variable in the model. Covariates were: (1) gender; (2) native language (English or other); (3) medical school location (United States or other); and (4) citizenship (United States or other). RESULTS: Examinees were .59 times as likely to pass USMLE if they were trained abroad. Additionally, examinees who reported having English as their primary language and U.S. citizenship were more likely to ultimately pass USMLE. Finally, though gender was also associated with passing USMLE, its practical significance was very small. CONCLUSION: Cox regression provides a useful tool for modeling performances in a continuous delivery model. Findings suggest that passing the USMLE sequence tends to be associated with native English-speaking USMGs who also hold U.S. citizenship.

Female↗

Efficacies of US Food and Drug Administration-licensed HIV-1-screening enzyme immunoassays for detecting antibodies to HIV-2.

To determine the efficacy of enzyme immunoassays (EIAs) for antibodies against HIV-1 in detecting HIV-2-infected blood, we tested 55 HIV-2-positive sera with seven Food and Drug Administration-licensed EIA kits. The percentage detection of HIV-2 sera giving positive reactions with these kits varied between the various manufacturers from 60 to 91%. Observations based on a small number of sera (n = 13), suggest that HIV-2-positive blood collected from apparently healthy people (blood donors, prenatal clinics) are detected with a greater frequency (means = 89%) than blood from AIDS patients or patients (n = 32) hospitalized with other infectious diseases (means = 72%). Based on these results and the low incidence of HIV-2 infection observed in the USA, it was concluded that screening with HIV-2-specific tests would not significantly increase the number of HIV-2-positive people detected by current screening programs. However, due to the poor sensitivity of certain HIV-1 assays for HIV-2 antibodies, HIV-2 sera without cross-reacting antibodies will escape detection. Surveillance for HIV-2 might then be improved by the availability of HIV-1 and HIV-2 combination assays.

Acquired Immunodeficiency Syndrome↗

Using licensed vocational nurses to provide telephone patient instructions in a health maintenance organization.

A pilot project was initiated at Kaiser Permanente Medical Offices in Fairfield, California, to determine whether licensed vocational nurses, working with registered nurses, can effectively and safely provide selected patient instructions by telephone to adult medical patients. We describe the environment, funding, implementation process, consultants' major findings, and results of the project's impact on staff and operations.

Adult↗

Licensed caregiver characteristics and staffing in California acute care hospital units.

PURPOSE: Concerns about declining quality of care and nurse staffing shortages led to legislation mandating minimum nurse-to-patient ratios in the state of California. Although research finds that better registered nurse (RN) staffing results in higher quality of care, little evidence exists on which to base specific nurse-patient ratios. The authors describe the results of a California survey characterizing licensed caregivers, identifying staffing levels by unit type, and describing how staffing levels vary across hospital types. METHODS: A stratified random sample of general acute care hospitals was surveyed to collect cross-sectional data on hospitals' nursing workforce and staffing practices and to assess the impact of potential patient-to-nurse staffing ratios. All academic medical centers; rural, private, and city/county hospitals; and hospitals affiliated with a large group-model health maintenance organization (HMO) were eligible for inclusion. RESULTS: Eighty hospitals were surveyed, representing all major metropolitan areas in the state. Acute care hospitals in California have diverse nursing staffs with variations in education, experience, and employment status. Considerable variations in skill mix were identified, with the proportion of RNs ranging from 30% to 84%, depending on the unit type surveyed. CONCLUSIONS: As states struggle with an anticipated critical shortage of RNs, these results have several implications for health and education policy. Future studies of this type will be needed to evaluate the impact of anticipated changes in the regulation of nurse staffing.

California↗

Soft tissue sarcoma risk in Swedish licensed pesticide applicators.

Two Swedish studies have suggested that exposure to phenoxy acid herbicides may cause soft tissue sarcoma. This association has been subsequently investigated in a number of epidemiologic studies. Results are inconsistent. In this study the risk of soft tissue sarcoma in a cohort of 20,245 Swedish pesticide applicators, of whom 72% were estimated to have been exposed to phenoxy acid herbicides, was analyzed. The cohort was observed by means of the Swedish Cancer Register from date of license until Dec 31, 1984, or until death if it occurred prior to that date. The mean follow-up time was 13.9 years. Seven patients with soft tissue sarcoma were observed compared with 7.7 expected on the basis of the incidence in Sweden. The relative risk was found to be 0.9 (95% confidence interval, 0.4 to 1.9). This finding is consistent with the hypothesis that exposure of phenoxy acid herbicides does not increase risk of soft tissue sarcoma.

Adult↗

Cancer incidence in a cohort of licensed pesticide applicators in Florida.

This study is a standardized incidence ratio (SIR) analysis of cancer incidence of licensed pesticide applicators in Florida, compared with that of Florida's general population. Through extensive data linkages, 33,658 applicators were assembled who had 1266 incident cancers and 279,397 person-years from January 1, 1975, to December 31, 1993. Disease risk from ethanol and tobacco use were significantly decreased. Among males, prostate cancer (SIR = 1.91; 95% confidence interval [CI], 1.72-2.13) and testicular cancer (SIR = 2.48; 95% CI, 1.57-3.72) were significantly elevated. No confirmed cases of soft tissue sarcoma (STS) were found, and the incidence of non-Hodgkin's lymphoma was not increased. There were few female applicators; nevertheless, cervical cancer incidence (SIR = 3.69; 95% CI, 1.84-6.61) was significantly increased, while the incidence of breast cancer was significantly decreased. Cancers that have been associated with estrogen disrupters were found in male, but not female, pesticide applicators. The lack of soft tissue sarcoma is at odds with prior literature associated with the use of phenoxy herbicides.

Adult↗