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At least 73 records · Page 4Linked to original sources

Bridging the gap: recruitment of African-American women into mental health research studies.

OBJECTIVE: To develop a strategy for recruiting African-American women into a research study for pregnant women. METHODS: With few exceptions, NIH-funded investigators must include women and minorities in clinical research. The authors used the recommendations provided in the Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research as a guide to help them reach out to African-American women in the community. RESULTS AND CONCLUSIONS: The outreach experience led to a conference for African-American women about mental health. On the basis of this experience, the authors formulated a five-pronged approach for recruitment of African-American women into their study. The NIH guidelines were useful for this purpose.

Female↗

Deficiencies in the National Institute of Health's guidelines for the care and protection of laboratory animals.

This paper is a critique of NIH guidelines for the care and protection of laboratory animals. It exposes four serious deficiencies in these guidelines: (1) failure to make it clear that the mere pursuit of knowledge does not justify using animals; (2) failure to give any guidance concerning what constitutes human benefit or well-being; (3) failure to countenance trade-offs between human benefit or well-being and animal well-being; (4) failure to clearly specify what constitutes keeping animals in an 'environment appropriate to the species and its life history.' It concludes with the suggestion that the construction and revision of these guidelines is too important to be left to the professionals.

Animal Care Committees↗

Hispanic research: implications of the National Institutes of Health guidelines on inclusion of women and minorities in clinical research.

Researchers have new opportunities to increase Hispanic health research as a result of the requirements in the March 1994 National Institutes of Health (NIH) guidelines on inclusion of women and minorities (and their subpopulations) as subjects in the biomedical and behavioral research projects that NIH supports. These guidelines are summarized and their implications for research are discussed here. Investigators must include women and minorities in their research involving human subjects and also present outreach plans for recruitment and retention of Hispanic and other participants into this clinical research. When clinical trials are planned, they need to be designed to measure differences in intervention effect in subpopulations when warranted. Investigators are challenged to develop new studies to fill the gaps in our knowledge about how radical/ethnic/cultural factors affect health and disease in Hispanic subgroups. This knowledge is necessary for designing studies that are culturally sensitive, enroll appropriate numbers of Hispanic participants, and ensure that the benefits of the research are made available to the Hispanic community.

Clinical Trials as Topic↗

Immunization of monkeys with recombinant complimentary deoxyribonucleic acid expressed zona pellucida proteins.

OBJECTIVE: To evaluate the effects of immunization with zona pellucida (ZP) proteins produced by recombinant complementary DNA (cDNA) technology for the elicitation and antibodies that inhibit sperm binding without altering ovarian function in the nonhuman primate. DESIGN: Controlled nonhuman primate study. SETTING: Controlled environment with individual housing of monkeys in facility approved by National Institutes of Health (NIH) guidelines. PARTICIPANTS: Monkeys housed and treated according to NIH regulations. INTERVENTIONS: Monkeys immunized and boosted at regular intervals with ZP proteins produced using recombinant cDNA techniques. MAIN OUTCOME MEASURE: Urinary estrogen, P, serum antibody levels, sperm-ZP binding, and ovarian morphology. RESULTS: Monkeys immunized with a recombinant rabbit 75-kd ZP protein expressed from a partial cDNA in the pEX bacteria expression system produce antibodies that interfere with ovarian follicular development and ovarian cyclicity. On the contrary, monkeys immunized with a recombinant rabbit 55-kd ZP protein develop antibodies that inhibit homologous sperm binding but do not affect ovarian follicular development or subsequent ovarian hormonal cyclicity. CONCLUSION: Monkey antibodies to the rabbit 75-kd ZP recombinant protein can be generated that inhibit ovarian cyclicity as desired for animal sterilization vaccines. Antibodies to the 55-kd ZP recombinant protein inhibit homologous monkey sperm binding to the ZP without altering ovarian endocrine function or morphology as is desired for human immunocontraception.

Animals↗

Understanding the impact of asthma in the 21st century.

OBJECTIVE: To describe the current status of asthma management in the United States, including the role of the Guidelines for the Diagnosis and Management of Asthma, developed by the National Institutes of Health (NIH), and the Health Plan Employer Data and Information Set (HEDIS) 2000, developed by the National Committee for Quality Assurance (NCQA). DATA SOURCES: This article is based on a presentation given by the author at a symposium entitled. Optimizing Clinical and Economic Outcomes in Asthma Management. at the Academy of Managed Care Pharmacy.s 2000 Educational Conference in San Diego, California, on October 5, 2000. CONCLUSIONS: Health care professionals have not yet fully convinced patients that asthma is a chronic disease requiring appropriate medication therapy and routine follow-up care. Asthma is often treated episodically, which is related to increased emergency room visits, hospitalizations, and acute-care visits. The appropriate treatment of asthma incorporates concepts from the NIH guidelines and begins with accurately classifying asthma based on pulmonary function and clinical symptoms. Inhaled corticosteroids (ICSs) are preferred first-line therapy for children as well as adults with persistent asthma. HEDIS 2000 defined a performance measure for asthma with which health care plans can be compared; this measure is based on administrative rather than clinical parameters. Use of fewer canisters of short-acting beta2-agonists per year is associated with relatively less risk of hospitalization for patients using ICS; even low-dose ICS therapy is effective in decreasing the asthma death rate.

Journal Article↗

Do the National Institutes of Health consensus guidelines for parathyroidectomy predict symptom severity and surgical outcome in patients with primary hyperparathyroidism?

BACKGROUND: The National Institutes of Health (NIH) consensus guidelines for parathyroidectomy in primary hyperparathyroidism were developed addressing only the classic symptoms and physiologic markers of hyperparathyroidism. The purpose of this study was to assess whether NIH guidelines predict the severity of all symptoms and the outcome of operation. METHODS: Symptom severity measurements using a disease-specific outcome tool called the parathyroidectomy assessment of symptoms (PAS) scores were previously obtained in patients with hyperparathyroidism. Patients were retrospectively stratified into 2 groups: group A, in which 1 or more of the NIH guidelines were met; and group B. in which operation was performed without any of the NIH criteria. For comparison, group C consisted of patients with non-toxic thyroid disease. PAS scores were collected preoperatively, and at 7 days, 3 months, and 12 months postoperatively. RESULTS: There were 95 patients in group A, 22 in group B, and 58 in group C. The median preoperative PAS scores for group A (354) and B (301) were not significantly different, however, both were more symptomatic than group C (176, P <.01). After parathyroidectomy, patients in both group A and B had a significant improvement in their PAS scores (A=177 and B=130, P <.05). CONCLUSIONS: Patients with no NIH criteria for operation are equally symptomatic compared with those who meet the NIH guidelines. Parathyroidectomy significantly improved these symptoms whether or not the patient met the NIH consensus guidelines.

Adult↗

Avoiding gender and minority barriers to NIH funding.

PURPOSE: To inform investigators of the National Institutes of Health (NIH) guidelines for the inclusion of women and minorities as subjects in clinical research and provide tips on avoiding barriers to federal funding. METHODS: Information about gender and minority barriers to funding was obtained by reviewing NIH policies, information submitted by applicants, and comments provided by NIH reviewers. ORGANIZING FRAMEWORK: A brief history of the goals of U.S. federal legislation to increase opportunities for obtaining information to help enhance health and disease treatment for all Americans and to detect and account for ethnic and gender differences is described. Examples were derived from NIH Summary Statement comments of initial review groups. CONCLUSIONS: Applications submitted to NIH are being barred from initial funding, even with excellent priority scores, if the plan for inclusion of women and minorities is judged to be scientifically unacceptable by the initial review group. This situation is correctable and avoidable.

Clinical Trials as Topic↗

Asthma: knowledge and practice patterns of Louisiana family physicians.

BACKGROUND: This study examines the practice patterns of Louisiana family physicians in managing asthma with attention to National Asthma Education Program (NAEP) guidelines. METHODS: A confidential two-page, multiple choice, 24-question survey was faxed to the 550 active members of the Louisiana Academy of Family Practitioners. It included questions related to the use of peak flow meters and pulse oximetry, nedocromil, theophylline, beta 2 agonists, suppressive antibiotics, inhaled steroids, as well as knowledge of published guidelines for classifying and treating asthma. RESULTS: Most of those who participated have an appropriate knowledge of asthma classification, but a sharp drop in the knowledge of the correct management of step 4 asthma was seen. A minority of respondents claimed knowledge of the NIH guidelines, but their management patterns for adult step 1, 2, and 3 asthma were largely in agreement with the guidelines. CONCLUSIONS: Unlike previous studies in the literature, this one shows good knowledge and reported practice compliance with the NAEP guidelines by Louisiana family physicians.

Adult↗

Patient education provided to asthmatic children: a historical cohort study of the implementation of NIH recommendations.

NIH guidelines for treatment of childhood asthma emphasize educating both patients and family about avoiding triggers and providing information to support self-management of asthma. To determine the extent to which primary care providers had implemented these recommendations, we examined the patient education provided to a cohort of asthmatic children (n = 331) between January and December 1994. During 1994 education of any type was documented for less than half the children. Provision of education was associated with asthma severity: An action plan for exacerbations was discussed with the majority with moderate or severe asthma (61%). Avoiding triggers (aOR: 2.38, 95% CI: 1.37-4.12) and treatment goals (aOR: 3.14, 95% CI: 1.46-6.75), were more likely to be discussed with children who were prescribed inhaled anti-inflammatory medication, after adjustment for asthma severity and age. Limited implementation of the NIH recommendations by primary care providers in our study may have reduced their impact on the management of childhood asthma.

Administration, Inhalation↗