Performance characteristics and costs of serological tests for brucellosis in a pastoralist community of northern Tanzania.

The control of brucellosis across sub-Saharan Africa is hampered by the lack of standardized testing and the use of tests with poor performance. This study evaluated the performance and costs of serological assays for human brucellosis in a pastoralist community in northern Tanzania. Serum collected from 218 febrile hospital patients was used to evaluate the performance of seven index tests, selected based on international recommendation or current use. We evaluated the Rose Bengal test (RBT) using two protocols, four commercial agglutination tests and a competitive enzyme-linked immunosorbent assay (cELISA). The sensitivity, specificity, positive predictive value, negative predictive value, Youden's index, diagnostic accuracy, and per-sample cost of each index test were estimated. The diagnostic accuracy estimates ranged from 95.9 to 97.7% for the RBT, 55.0 to 72.0% for the commercial plate tests, and 89.4% for the cELISA. The per-sample cost range was $0.69-$0.79 for the RBT, $1.03-$1.14 for the commercial plate tests, and $2.51 for the cELISA. The widely used commercial plate tests performed poorly and cost more than the RBT. These findings provide evidence for the public health value of discontinuing the use of commercial agglutination tests for human brucellosis in Tanzania.

Development of leadership self-efficacy and collective efficacy: adolescent girls across castes as peer educators in Nepal.

Adolescent girls in Nepal face enormous social barriers to accessing education and health services due to exclusionary socio-religious traditions and years of conflict. The programme and study reported here address two issues that a national assembly of in-school and out-of-school adolescent girls, who had completed a basic life skills class, and, in the case of unschooled girls, an intensive literacy course, identified as important to their well-being - menstrual restrictions and HIV awareness and prevention. Local non-governmental organizations developed a peer education programme in three districts of Nepal that paired girls from different castes and different educational levels. The programme sought to increase peer educators' (PE) leadership and collective efficacy for informing peers and adults in their communities about the effects that these issues have on women and girls. In total, 504 girls were selected and trained as PEs. They conducted targeted discussion sessions with other girls and organised mass awareness events, reaching 20,000 people. Examination of the effects of participating in the programme on key outcome measures showed that leadership self-efficacy, which was a central theoretical construct for the programme, provided a strong predictor of both increased HIV knowledge and of practicing fewer menstrual restrictions at endline. The project demonstrated that girls from different caste and educational backgrounds are able to work together to change individual behaviour and to address socio-cultural norms that affect their lives and well-being within their communities.

Assessment of the biological and pharmacological effects of the alpha nu beta3 and alpha nu beta5 integrin receptor antagonist, cilengitide (EMD 121974), in patients with advanced solid tumors.

BACKGROUND: Cilengitide, an antiangiogenic agent that inhibits the binding of integrins alpha(nu)beta(3) and alpha(nu)beta(5) to the extracellular matrix, was studied at two dose levels in cancer patients to determine the optimal biological dose. PATIENTS AND METHODS: The doses of cilengitide were 600 or 1200 mg/m(2) as a 1-h infusion twice weekly every 28 days. A novel dose escalation scheme was utilized that relied upon the biological activity rate. RESULTS: Twenty patients received 50 courses of cilengitide with no dose-limiting toxic effects. The pharmacokinetic (PK) profile revealed a short elimination half-life of 4 h, supporting twice weekly dosing. Of the six soluble angiogenic molecules assessed, only E-selectin increased significantly from baseline. Analysis of tumor microvessel density and gene expression was not informative due to intrapatient tumor heterogeneity. Although several patients with evaluable tumor biopsy pairs did reveal posttreatment increases in tumor and endothelial cell apoptosis, these results did not reach statistical significance due to the aforementioned heterogeneity. CONCLUSIONS: Cilengitide is a well-tolerated antiangiogenic agent. The biomarkers chosen in this study underscore the difficulty in assessing the biological activity of antiangiogenic agents in the absence of validated biological assays.

Regulatory perspective on clinical trials and end points for female sexual dysfunction, in particular, hypoactive sexual desire disorder: formulating recommendations in an environment of evolving clinical science.

This article examines the history, current status, and potential future challenges in the development of drugs for female sexual dysfunction (FSD) from the perspective of the United States Food and Drug Administration. In particular, the article focuses on testosterone therapy for hypoactive sexual desire disorder (a component of FSD), and the role of the Division of Reproductive and Urologic Products in facilitating the development of safe and effective therapies for this indication.

Person-task-context: a model for designing curriculum and in-training assessment in postgraduate education.

Structured curricula for senior house officers have often been lacking. The aim of this study was to trial a person-task-context model in designing a curriculum and in-training assessment (ITA) programme for SHOs in internal medicine. A working group designed the programme based on triangulation of information from interviews with trainees and programme directors, analysis of patient case mix and national quality assurance data. The interview data showed that the main difference currently between trainee levels was in expected degree of responsibility for patient management rather than in actual tasks. Key learning needs were how to take a structured approach to the tasks and get an overview of situations. SHOs expressed a need for explicit learning goals and standards of performance. SHOs requested formal teaching in non-medical aspects of competence such as communication, interpersonal skills and professionalism. This article points out how consideration of the type of trainees involved, the tasks they must do and learn, and the context in which they work are important in designing postgraduate curricula. The person-task-context model can be used to tailor curricula and ITA that support learning and may be especially beneficial in promoting learning in non-dominant areas of a specialty.

Non-invasive assessment of tumor proliferation using triple quantum filtered 23/Na MRI: technical challenges and solutions.

We address the development of triple-quantum-filtered sodium MRI as a non-invasive surrogate measure for cell proliferation in brain tumors. We demonstrate that through careful consideration of the theoretical description of the signal, triple-quantum-filtered sodium images of adequate signal-to-noise ratio (SNR) can be acquired in clinically acceptable imaging times.

Assessing guidelines for use in family practice.

With more than 1000 new guidelines produced annually over the past decade, it is impossible for the practicing family physician to determine which ones should be adapted into their clinical practice. The Ontario Ministry of Health and Long-Term Care and the Ontario Medical Association formed the Guideline Advisory Committee (GAC) in 1997 to assess and disseminate guidelines that would improve the quality and utilization of health care services in the province. Over the past 3 years the GAC has developed a strategy to identify important topics, to rank order guidelines published on these topics based on the quality of their development, and to reformat guidelines as necessary to make them user-friendly for implementation in clinical practice. The GAC is currently assessing a number of strategies to enhance the dissemination of selected guidelines to improve the quality of care delivered in the province.

Is life of infinite value?

It is possible and necessary to compare stretches of human life with other goods, such as the good of conserving resources for others. A minute of human life is not of infinite value; all else being equal, a minute of life is less valuable than 10 years of the same life. Nevertheless, this ability to evaluate human life does not necessarily lead to total commodification of human life.

Early childhood chronic illness: comparability of maternal reports and medical records.

OBJECTIVES: The research reported here seeks to quantitatively assess the comparability of two widely used sources of information on child health: maternal reports and medical records. The analysis provides a comparison of how well maternal reports and medical provider data agree on 15 types of chronic health conditions, ranging from specific illnesses such as asthma or sickle cell anemia to broader categories such as chronic heart or orthopedic conditions, to impairments such as vision, hearing, or speech problems. METHODS: This study uses data on a nationally representative sample of 6201 preschool aged children whose mothers participated in the 1991 Longitudinal Followup (LF) to the 1988 National Maternal and Infant Health Survey (NMIHS) and whose identified health care providers supplied medical visit data for the children. The LF and NMIHS were conducted by the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC), in collaboration with a number of other agencies of the Federal Government. In the 1991 LF survey, the mothers' questionnaire included questions on chronic and acute health conditions, accidents requiring medical attention, and hospital admissions for their children that had been included in the 1988 NMIHS. The mothers were also asked to grant NCHS permission to request medical records from the children's medical providers. RESULTS: Kappa statistics reveal poor agreement for 12 of 15 conditions studied. Weighted prevalence estimates vary widely across sources. For some conditions, despite apparently similar prevalence estimates from the two sources, mothers' reports and medical records identified very different groups of children as "cases." Concurrence rates were lower for children from poor, less educated, and Hispanic families. Reasons for and implications of these findings are also discussed.

Diabetes training for dietitians: needs assessment, program description, and effects on knowledge and problem solving.

Recent changes in management and medical nutrition therapy for diabetes mellitus have produced a need to retrain many practicing dietitians. To meet this need, a multidisciplinary group experienced in medical nutrition therapy and educational methods used a formal needs-assessment process to design a new training program. Sugar is Not a Poison (SNAP): The Dietitian's New Role in Diabetes Management is a 2 1/2-day program that uses written text, didactic presentation, and exercises that simulate patient encounters to accomplish 12 learning objectives. Program evaluations show high levels of participant satisfaction. Mean (+/- standard deviation) scores on pre- and postests of knowledge and problem solving were 69 +/- 13% and 86 +/- 9%, respectively (P < 0.01). The SNAP program needs assessment, training methods, and knowledge problem-solving test are relevant to all types of education programs in clinical dietetics.

Does the Complications Screening Program flag cases with process of care problems? Using explicit criteria to judge processes.

BACKGROUND: The Complications Screening Program (CSP) aims to identify 28 potentially preventable complications of hospital care using computerized discharge abstracts, including demographic information, diagnosis and procedure codes. OBJECTIVE: To validate the CSP as a quality indicator by using explicit process of care criteria to determine whether hospital discharges flagged by the CSP experienced more process problems than unflagged discharges. METHODS: The (CSP was applied to computerized hospital discharge abstracts from Mledicare beneficiaries > 65 years old admitted in 1994 to hospitals in California and Connecticut for major surgery or medical treatment. ()f 28 CSP complications, 17 occurred sufficient frequently to study. Discharges flagged (cases) and unflagged (controls) by the (CSP were sampled and photocopied medical records were obtained. Physicians specified detailed, objective, explicit criteria, itemizing 'key steps' in processes of care that could potentially have prevented or caused complications. Trained nurses abstracted medical records using these explicit criteria. Process problem rates between cases and controls were compared. RESULTS: The final sample included 740 surgical and 416 medical discharges. Rates of process problems were high, ranging from 24.4 to 82.5% across CSP screens for surgical cases. Problems were lower for medical cases, ranging from 2.0 to 69.1% across CSP screens. Problem rates were 45.7% for surgical and 5.0% for medical controls. Rates of problems did not differ significantly across flagged and unflagged discharges. CONCLUSIONS: The CSP did not flag discharges with significantly higher rates of explicit process problems than unflagged discharges. Various initiatives throughout the USA use techniques similar to the CSP to identify complications of care. Based on these CSP findings, such approaches should be evaluated cautiously.

An assessment of the influence of clinical demonstrations on the confidence of undergraduate dental students, when treating patients requiring removable partial dentures.

AIM: This study was designed to assess the influence of clinical demonstrations, on the confidence of undergraduate dental students, when treating patients requiring removable partial dentures. METHOD: The confidence of 45 undergraduate dental students treating their first patient requiring removable partial dentures was assessed using questionnaires. 23 students were given demonstrations prior to carrying out the treatment; the remainder did not receive a demonstration. Outcome was assessed by the time taken to complete the procedures to a clinically acceptable standard. RESULTS: All the students indicated high levels of agreement with a statement expressing their confidence in coping with the clinical procedures undertaken. The more confident students completed their clinical procedures more quickly than other students, irrespective as to whether they had received a demonstration or not. There was a higher proportion of more confident students in the groups who had received a clinical demonstration; it can therefore be concluded that these groups performed better, as measured by the time taken to achieve the required clinical standard. All the students who had received a demonstration believed they had benefited from it, whilst 67% of the students who had not received a demonstration believed they would have benefited from one. Analysis of the students' comments indicated that demonstrations facilitated confidence, communication skills, understanding and recall in the clinical situation. Students who did not perceive a benefit from the demonstrations believed that they had more time for one to one teaching. CONCLUSION: This study showed that those students who had received a clinical demonstration immediately prior to treating their patients believed they were more confident and as a result their performance was improved. Clinical demonstrations are time consuming, but they would appear to be time well spent.

The usefulness of an assessment of emotional involvement of HIV-positive mothers and their infants.

INTRODUCTION: A positive mother-infant relationship is crucial for optimal child development; however, many factors may interfere with the development of a such a relationship. One group at risk for compromised mother-infant interactions is women with HIV infection. The purposes of this study were (a) to examine the usefulness of the Attachment During Stress scale (ADS) for measuring the emotional involvement of HIV-positive mothers with their infants during a clinic visit and (b) to explore the effects of maternal health status, age, parity, and educational level on mother-infant involvement. METHOD: A descriptive, longitudinal study was conducted with 57 primarily African American HIV-positive mothers and their infants who were patients at 1 of 2 regional referral centers. The ADS was completed during the child's physical examination at 3, 6, and 12 months of age, and mothers completed questionnaires during these visits. RESULTS: Maternal age, education level, health status, and parity were not related to maternal emotional involvement. However, the emotional involvement of the mother and infant were correlated (r = 0.73, P < .001). DISCUSSION: These findings suggest that the ADS may be a useful screening tool to supplement the nurse's clinical judgment in a pediatric outpatient setting. The ADS provides some useful information about the emotional involvement of the mother and infant, although it does not provide a comprehensive assessment of their relationship.

The conditional binomial test revisited for clinical trials.

McNemar's test is used to test the hypothesis that one treatment is better than another in a matched-pair design for binary outcomes. The conditional binomial test in such a matched-pair design is the exact McNemar test. However, in many clinical trials, one wants to establish equivalency between two treatments. We discuss how to use a conditional binomial test to establish equivalency between two treatments in a matched-pair design. Sample size and power determination for each conditional binomial test are calculated. Some statistical properties of the tests are analyzed through Monte Carlo simulation.

Reduced ratio of male to female births in several industrial countries: a sentinel health indicator?

CONTEXT: The sex ratio of 1.06:1, the ratio of male to female births, has declined over the past decades. Recent reports from a number of industrialized countries indicate that the proportion of males born has significantly decreased, while some male reproductive tract disorders have increased. OBJECTIVES: To examine the evidence for declines in the male proportion at birth and suspected causes for this decline, and to determine whether altered sex ratio can be considered a sentinel health event. DATA SOURCES: Birth records were analyzed from national statistical agencies. STUDY SELECTION: Published analyses of trends in ratio of males to females at birth and studies of sex determinants evaluating epidemiological and endocrinological factors. DATA EXTRACTION: Proportion of males born: 1950-1994 in Denmark; 1950-1994 in the Netherlands; 1970-1990 in Canada; and 1970-1990 in the United States. DATA SYNTHESIS: Since 1950, significant declines in the proportion of males born have been reported in Denmark and the Netherlands. Similar declines have been reported for Canada and the United States since 1970 and parallel declines also have occurred in Sweden, Germany, Norway, and Finland. In Denmark, the proportion of males declined from 0.515 in 1950 to 0.513 in 1994. In the Netherlands, the proportion of males declined from 0.516 in 1950 to 0.513 in 1994. Similar declines in the proportion of males born in Canada and the United States are equivalent to a shift from male to female births of 8600 and 38000 births, respectively. Known and hypothesized risk factors for reduced sex ratio at birth cannot fully account for recent trends. CONCLUSION: Patterns of reduced sex ratio need to be carefully assessed to determine whether they are occurring more generally, whether temporal or spatial variations are evident, and whether they constitute a sentinel health event.

Ambulatory management of chemotherapy-induced fever and neutropenia in adult cancer patients.

OBJECTIVE: To review the literature on the management of low-risk adults with chemotherapy-induced fever and neutropenia (CIFN). Included in the review are methods to identify these patients, management options, and economic impact associated with nontraditional treatment options. DATA SOURCES: A MEDLINE and bibliographic search (January 1966-December 1997) for all English-language studies evaluating the identification and treatment of adult, low-risk CIFN patients was completed. Reference lists from identified articles also served as literature sources. STUDY SELECTION AND DATA EXTRACTION: All human studies identified from the data sources were evaluated. Pertinent information, excluding pediatric studies, was selected and critically evaluated for discussion. DATA SYNTHESIS: Alterations in prominent bacterial isolates in CIFN, newer antibiotic choices, enhanced focus on patient comfort, and cost-containment directives have promoted recent research identifying adult cancer patients with low-risk CIFN. Using this information to select low-risk CIFN patients, several investigators have completed trials using antibiotic therapy applicable to the ambulatory setting. Additionally, some investigators have included the use of an oral outpatient antibiotic regimen. Limited data indicate that this approach is a reasonable treatment option for selected patients. CONCLUSIONS: A subset of adult patients with CIFN are at low risk for serious morbidity and mortality when treated with broad-spectrum antibiotics in the ambulatory setting. Managing these patients with this approach requires close patient selection, intense follow-up, data collection, and ongoing evaluation to determine efficacy and patient safety. Currently, ambulatory treatment with oral antibiotics for CIFN is not considered standard of care. Further studies of larger size designed to confirm low-risk patient characteristics and optimal antibiotic selection are required.