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DEC-net: the development of the European register of clinical trials on medicines for children.

BACKGROUND: The need to register a clinical trial in a public database has been widely discussed in the last few years. Several general clinical trial registers have been developed, but none are dedicated to children. A web-based register of trials on drug therapy in children was therefore developed. PURPOSE: The general objective of the project, called DEC-NET (European register of clinical trials on medicines for children - drug evaluation in children) and supported by the European Community, is to provide the scientific community with a flexible tool for promoting communication and collaboration among researchers, disseminating clinical trial results and facilitating patient access and recruitment to trials. METHODS: We identified a set of trial data to be collected, including general trial information, recruitment information, eligibility criteria, clinical trial characteristics, location and contact information, study drugs, study sponsor and results. The system was set up to allow authorized users (working in Italy, Spain, France and UK) to enter, handle and monitor the trial information. Medical data dictionaries (ie, ICD-9 and ATC) were used in order to make the data-entry and the search and data analysis procedures easier. A multilingual approach in data handling and presentation made accessing trial information in English and in the language of the country where the study is located feasible. Search and browsing tools were set up to allow investigators, researchers, and citizens to freely search and browse the entire register and access the details of trials meeting the search criteria. RESULTS: The DEC-net register (http://www.dec-net.org) was opened for trial notification and consultation. LIMITATIONS: DEC-net currently involves four European countries and is a pilot project. CONCLUSIONS: It is hoped that what has been achieved so far represents only the beginning of a long-term project, and the next step will be to extend the register's use to other European countries.

Child↗

Developing a teaching portfolio in nursing education: a reflection.

Presenting teaching accomplishments through a portfolio promotes self-reflection and provides direction for improvement and advancement decisions. The authors examine experiences, insights, and reflections about their participation in a pilot project introducing teaching portfolios. Themes of taking stock, documenting practice, and reflecting emerge. Their experiences of completing teaching portfolios and personal growth as educators and colleagues are described.

Attitude of Health Personnel↗

Alcoholism: the response of a public hospital.

This report presents an analysis of the Alcohol Intervention Program (AIP) at Parkland Memorial Hospital in Dallas, Texas. This pilot project was initiated in January of 1983. A total of 1,822 patients were screened by two trained counselors. Operated in the emergency room, the project significantly reduced the rate of both hospital admissions and readmissions for patients with alcohol-related illnesses. This project demonstrated its effectiveness by making appropriate referrals to local alcoholism service providers. A total of 387 patients were referred directly to Alcoholics Anonymous and 440 were referred to residential alcoholism programs. Of the latter group, follow-up documentation demonstrated that nearly half of those referred remained in treatment for the duration of the program.

Alcoholism↗

Cataract surgery at district hospital level.

Cataract remains the leading cause of blindness worldwide, curable though, by a simple procedure. The backlog of cataract patients in developing countries is mounting despite sustainable and downright efforts by health ministries, international voluntary and non-governmental organisations [1]. The current situation has put many developing countries in a difficult dilemma. The authors present a review of a pilot-project in decentralised eye-care in Mutasa District, Zimbabwe. Cataract surgery is performed by a district general doctor as an alternative to clearing the cataract back-log in developing countries, as suggested in several studies [2-5]. It is important to persuade the health ministries to adopt this simple and cheap policy [6,7].

Cataract Extraction↗

The effect of education and safety devices on scald burn prevention.

A prospective study was designed to evaluate the effects of education on the incidence of pediatric scald burns. Demographic data from our Trauma Registry identified the Zip code area of greatest risk. Eighty of 121 families with children in a large rental property were chosen randomly for the education program. Twenty of these families also had an anti-scald device installed in the bathtub faucet; all had two or more children under age 5 years. Families were surveyed before and after intervention. Safety knowledge improved post-education as judged by correct survey responses. Although 90% of the families had water heaters set at "warm" (< or = 120 degrees F), the actual temperature at the tap was above 130 degrees F in 71%. The anti-scald devices did work, but at 9 months all but one had been removed because of sediment buildup, which prevented water flow. In the year of the study, the number of scald burns from the target Zip code area decreased from 15 to 12. This was a pilot project for programs that can test public response to general safety education. An anti-scald device in conjunction with education works well in theory, but a better device needs to be engineered. In view of discrepancies between water heater settings and tap water temperature, housing authorities could play a vital role in implementing safety measures.

Accident Prevention↗

Musician health and safety: Preventing playing-related musculoskeletal disorders.

Musicians are exposed to high-risk musculoskeletal activities such as repetition, hours of exposure, and awkward postures when playing instruments. These activities may result in playing-related musculoskeletal disorders. Musicians often work part-time or seasonally or are self-employed. Thus, they may be uninsured or underinsured and may delay seeking care for these painful and potentially disabling conditions. Prevention of playing-related musculoskeletal disorders includes identification of both intrinsic (e.g., musician strength and flexibility) and extrinsic (e.g., musician posture while playing an instrument) factors involved in the interface between musicians and their instruments and the playing environment (e.g., rest breaks or hours of practice). Student occupational health nurse practitioners in this pilot project performed outreach and comprehensive screening and treatment for a small group of musicians diagnosed as having playing-related musculoskeletal disorders. Tendon and nerve gliding exercises were a key component of the treatment plan.

Adult↗

Use of an outcomes research collaborative training curriculum to enhance entry-level dietitians' and established professionals' self-reported understanding of research.

This project pilot tests a unique outcomes research training curriculum that prepares entry-level dietitians (goal 1) and provides established dietetics professionals with the resources to successfully execute an outcomes research plan (goal 2). The learning objectives for each goal were met via lectures and assignments in two courses, one taught in the fall and one in the winter semester of the second (senior) year of the Coordinated Program at the University of Missouri. At their respective healthcare facilities, registered dietitian (RD) preceptors along with the students progressed through all stages of the research process, from proposal development to data presentation. At the completion of the process, a questionnaire was administered to students and preceptors to evaluate the curriculum. Fourteen of the 15 possible student respondents and four of the five possible RD preceptors returned their questionnaires. Salient findings as well as actions to be taken in subsequent course offerings include: (a) clarify expectations, (b) limit geographical distance, (c) increase in-class time, (d) limit project scope, (e) add more statistics training/practice, (f) introduce outcomes research earlier, (g) preceptors' participation was positive. This endeavor allowed us to acquire the information and experience required to make outcomes research training a more significant component of dietetics education.

Cooperative Behavior↗

Computer-assisted instruction in radiology.

We developed an interactive computer system to support various educational uses. The system allowed numerous instructors to create lessons or tests in a flexible, personalized fashion. As a pilot project, the system was used to develop and administer a computer-driven final examination in a didactic radiology course for second-year medical students. It was our objective to change the examination into an enjoyable experience that would also bring about long-term learning gains. The computer added immediate feedback to the testing situation.

Computer-Assisted Instruction↗

The Union Health Center: a working model of clinical care linked to preventive occupational health services.

As health care provision in the United States shifts to primary care settings, it is vital that new models of occupational health services be developed that link clinical care to prevention. The model program described in this paper was developed at the Union Health Center (UHC), a comprehensive health care center supported by the International Ladies Garment Workers Union (now the Union of Needletrades, Industrial and Textile Employees) serving a population of approximately 50,000 primarily minority, female garment workers in New York City. The objective of this paper is to describe a model occupational medicine program in a union-based comprehensive health center linking accessible clinical care with primary and secondary disease prevention efforts. To assess the presence of symptoms suggestive of occupational disease, a health status questionnaire was administered to female workers attending the UHC for routine health maintenance. Based on the results of this survey, an occupational medicine clinic was developed that integrated direct clinical care with worker and employer education and workplace hazard abatement. To assess the success of this new approach, selected cases of sentinel health events were tracked and a chart review was conducted after 3 years of clinic operation. Prior to initiation of the occupational medicine clinic, 64% (648) of the workers surveyed reported symptoms indicative of occupational illnesses. However, only 42 (4%) reported having been told by a physician that they had an occupational illness and only 4 (.4%) reported having field a workers' compensation claim for an occupational disease. In the occupational medicine clinic established at the UHC, a health and safety specialist acts as a case manager, coordinating worker and employer education as well as workplace hazard abatement focused on disease prevention, ensuring that every case of occupational disease is treated as a potential sentinel health event. As examples of the success of this approach, index cases of rotator cuff tendonitis, lead poisoning, and formaldehyde overexposure in three patients and their preventative workplace follow-up, affecting approximately 150 workers at three worksites, are described. Work-related conditions diagnosed during the first 3 years of clinic operation included cumulative trauma disorders (141 cases), carpal tunnel syndrome (47 cases), low back disorders (33 cases), lead poisoning (20 cases), and respiratory disease (9 cases). This pilot project represents a new model for effective integration of clinical care and occupational disease prevention efforts within a primary care center. It could serve as a prototype for development of such services in other managed and primary care settings.

Ambulatory Care Facilities↗

An innovative approach to training hospital-based clinicians for bioterrorist attacks.

The recent attacks of September 11, 2001, and the subsequent dissemination event of anthrax in the United States demonstrated the necessity for hospitals to initiate bioterrorism education for clinicians. Events such as the release of sarin gas into the Tokyo subway by the Aum Shinrikyo cult provided some insight into how quickly emergency medical personnel may be overwhelmed by causalities of unconventional weapons. Educational interventions to prepare hospital-based practitioners for such disasters must fit among the demands of patient care, administrative duties, and continuing education within specialties. In addition, the priority placed on the topic, confusion about reputable resources to consult, and concerns of funding for preparedness training mandate the need for an authoritative, comprehensive, and easily accessible approach. A pilot project supported in part by the Agency for Healthcare Research and Quality was developed to facilitate streamlining of preparedness efforts through the implementation of interactive screen savers as an alternative to traditional educational modalities. This report presents the successful application of this model, which was quantified with pretests and posttests given to users of the system.

Bioterrorism↗

The sustainability of hepatitis B immunization within the Universal Immunization Programme in India.

Based on the recommendations of the World Health Organization, India as a member-state is likely to implement universal immunization against hepatitis B through the existing Universal Immunization Programme (UIP). A pilot project is already under progress in two municipal zones of Delhi. This paper begins by reviewing epidemiological features of hepatitis B in India, some established aspects and other emerging trends. The gaps in the existing knowledge base are also given due consideration. The current recommendation is to deliver the vaccine at zero-day for infants in the absence of facilities for antenatal screening and immunoglobulin administration. The paper explores the potential pitfalls for integrating the proposed hepatitis B vaccination with the DPT (diphtheria/pertussis/tetanus) schedule. Based on the findings of the National Family Health Survey, the likely coverage for the states is estimated for both the schedules--zero-day and with DPT. The performance of the pilot phase is reviewed through the results of a coverage survey. The paper also estimates the resources that should be committed to launch the universal immunization of hepatitis B vaccination and the sustainability issues thereof. The paper finally concludes with the position that hepatitis B immunization will 'sink or sail' with the UIP. Further, this should act as an engine for recharging the infrastructure and functioning of the public health system and promote general preventive practices like universal precautions.

Diphtheria-Tetanus-Pertussis Vaccine↗

Shared geriatric mental health care in a rural community.

INTRODUCTION: A pilot project in shared mental health care was initiated to explore opportunities to increase the capacity of the rural primary care system as a resource for older people with mental health needs. This was done within a framework for the delivery of best practices in geriatric mental health outreach. METHODS: Shared-care strategies combining education and clinical consultation between mentor psychiatrists and family physicians were implemented and then evaluated after one year to identify key factors in the success of approaches to shared mental health care for older people in a rural setting. RESULTS: Results provided new insights into shared care between primary care and specialty geriatric mental health services, rural geriatric mental health service delivery, developmental phases in service learning approaches, and building knowledge networks to promote continuing best practices. CONCLUSION: The results from the project's process evaluation have been integrated into the development of a permanent shared geriatric mental health care service for the rural setting. Preparation for an outcome evaluation that will focus on the impact on patient care has also been initiated.

Aged↗

The team concept in supervised practice: benefits for students and preceptors.

Economic pressures in health care today make it difficult for many practitioners to provide educational opportunities for dietetic students. Staff members at practice settings, with increased responsibilities on the job, stipulate limitations on the numbers of students and request that they be better prepared. Dietetic educators are faced with maintaining the quality of supervised practice, particularly for new students, in spite of reduced availability of practice settings and time limitations of staff preceptors. An option is the multiple assignment--a technique in which students function as a team. Three students, each with a set of specialized objectives, cooperate in the care of one patient: One is the doer, one is the resource person, and one is the evaluator. This methodology was adapted to dietetics, and a pilot project was conducted in a hospital setting. Three student teams (nine students), three clinical preceptors, and one faculty member participated. Students achieved at high levels and demonstrated great satisfaction in their supervised practice. For staff preceptors, the team approach reduced student-related time involvement by one-half and promoted the quality of student performance. Guidelines for further application of the model are given.

Dietetics↗

Transforming our vision: emancipatory career planning for nurses.

Canadian nurses are experiencing profound and often disturbing changes in the health care sector. Not only have the number of jobs decreased but the nature and expectations of those jobs are changing dramatically. While these changes have raised nurses' anxiety, the changes simultaneously have presented nurses with an opportunity to transform their vision of nursing and their role in health care. This article describes a career planning pilot project for nurses which employed Freire's model of emancipatory learning. Based on the theoretical foundations of narrative psychology and critical social theory a series of four workshops were offered. Comments from the evaluation results indicate that the workshop was a transformative experience for the participants. Future implications for career planning for nurses are discussed.

Canada↗

Lessons learned in implementing a staff education program in pain management in the acute care setting.

With the release of Acute Pain and Cancer Pain Guidelines from the federal government, many healthcare agencies will be instituting programs to improve pain management. The authors describe a pilot project in acute pain management that did not yield desired results. On the basis of this experience and through a review of the literature, information is provided to staff development educators about problems and issues in planning and executing a program in pain management using structure, process, and outcome as a framework.

Acute Disease↗

Impact of an alcohol withdrawal syndrome practice guideline on surgical patient outcomes.

STUDY OBJECTIVE: To standardize treatment of alcohol withdrawal syndrome (AWS) in surgical patients using an AWS practice guideline with a symptom-triggered approach. DESIGN: Prospective interventional (pilot group) and retrospective (comparison group). SETTING: University teaching hospital. PATIENTS: Thirty-eight trauma, orthopedic, and general surgery patients identified at risk for AWS in the pilot group, and 34 patients who were managed using nonstandardized approaches. INTERVENTIONS: At-risk patients in the pilot group were assessed using the AWS Type Indicator. They received lorazepam, clonidine, or haloperidol, based on AWS Type Indicator assessment and AWS practice guideline criteria. MEASUREMENTS AND MAIN RESULTS: A standardized symptom-triggered approach to managing AWS was expected to decrease the use of benzodiazepines, avoid undertreatment of adrenergic hyperactivity and delirium, decrease the need for sitters and physical restraints, and reduce hospital length of stay. Pilot patients received a mean of 23 mg less benzodiazepine (p=0.01), 0.1 mg more clonidine (p=0.01), and 20 mg less haloperidol (p=0.06) than comparison patients. Pilot patients also required significantly fewer sitter hours (p=0.04) and hours of restraint use (p=0.09) than comparison patients. No significant differences were found between groups for length of stay (p=0.77). CONCLUSIONS: This pilot project suggests that trauma, orthopedic, and general surgery patients at risk for AWS can be safely and effectively managed with a standardized, symptom-triggered approach. Moreover, this approach decreased the amounts of benzodiazepines and haloperidol administered to patients at risk for AWS.

Adolescent↗

Gabapentin in the treatment of cocaine dependence: a case series.

BACKGROUND: Although multiple medications have been studied for the treatment of cocaine dependence, no medication has been shown to have a robust effect on craving and use. This pilot project was designed to evaluate the safety and tolerability of gabapentin in subjects with cocaine dependence. METHOD: Thirty cocaine-dependent subjects (DSM-IV criteria) were enrolled in an 8-week, open-label trial of 1,200 mg/day of gabapentin in divided doses. Urine drug screens, subjective measures of craving, and cocaine use interviews were conducted at each weekly visit. RESULTS: Baseline rating of amount and frequency of craving decreased significantly by week 8 (78% vs. 25% for amount, p = .000; 74% vs. 23% for frequency, p = .004). Positive urine drug screens for cocaine decreased from 86% at baseline to 29% at weeks 4 and 8. There were no reports of significant side effects or adverse events. CONCLUSION: This pilot study indicates that gabapentin is safe and well tolerated and may be beneficial in the treatment of cocaine dependence. A placebo-controlled trial would be of interest.

Acetates↗

Acanthosis Nigricans as an early clinical proxy marker of increased risk of type II diabetes.

Diabetes affects 6% of the national population, yet approximately 50% of persons with diabetes remain undiagnosed and receive no treatment. In specific populations, Acanthosis Nigricans (AN) may serve as an early clinical proxy marker of increased risk of type II diabetes. The results of this pilot project to screen selected school age students in New Mexico for AN indicate that a large number of these students may be at increased risk for developing type II diabetes as young adults. The future burden of diabetes on individuals, families, communities, and health care systems may be greater than previously recognized.

Acanthosis Nigricans↗