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The Division of Lung Diseases of the National Heart, Lung, and Blood Institute (NHLBI) held a workshop to develop recommendations on topics, methodologies, and resources for comparative effectiveness research (CER) that will guide clinical decision making about available treatment options for lung diseases and sleep disorders. A multidisciplinary group of experts with experience in efficacy, effectiveness, implementation, and economic research identified (a) what types of studies the domain of CER in lung diseases and sleep disorders should include, (b) the criteria and process for setting priorities, and (c) current resources for and barriers to CER in lung diseases. Key recommendations were to (1) increase efforts to engage stakeholders in developing CER questions and study designs; (2) invest in further development of databases and other infrastructure, including efficient methods for data sharing; (3) make full use of a broad range of study designs; (4) increase the appropriate use of observational designs and the support of methodologic research; (5) ensure that committees that review CER grant applications include persons with appropriate perspective and expertise; and (6) further develop the workforce for CER by supporting training opportunities that focus on the methodologic and practical skills needed. [ABSTRACT FROM AUTHOR]

Over the last 20 years, the prevalence of asthma has nearly doubled and now affects 8-10% of the population in the United States. Asthma also remains a major illness in terms of morbidity and suffering, and is the leading cause of hospitalizations in children under 15 years of age. Because asthma poses a lifelong burden to patients and society, efforts to increase the understanding of its pathogenesis are a key factor leading to its control and cure. Consequently, the National Heart, Lung, and Blood Institute (NHLBI) convened a Working Group of extramural experts, entitled 'Future Research Directions in Asthma,' on April 9-10, 2003, to identify research areas of greatest promise and opportunity in the field of asthma. The priority areas identified for research in asthma include: (1) innate immunity, adaptive immunity, and tolerance; (2) mechanisms and consequences of persistent asthma and asthma exacerbations; (3) airway remodeling: clinical consequences and reversibility (clinical relevance and resolution); (4) genetics/gene-environment interactions, pharmacogenetics; (5) intervention/prevention/therapeutics; and (6) vascular basis of asthma. [ABSTRACT FROM AUTHOR]

Background: "Asthma-related quality of life" (QOL) refers to the perceived impact that asthma has on the patient's QOL., Objective: National Institutes of Health institutes and other federal agencies convened an expert group to recommend standardized measures of the impact of asthma on QOL for use in future asthma clinical research., Methods: We reviewed published documentation regarding the development and psychometric evaluation; clinical research use since 2000; and extent to which the content of each existing QOL instrument provides a unique, reliable, and valid assessment of the intended construct. We classified instruments as core (required in future studies), supplemental (used according to the study's aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an National Institutes of Health-organized workshop convened in March 2010 and finalized in September 2011., Results: Eleven instruments for adults and 6 for children were identified for review. None qualified as core instruments because they predominantly measured indicators of asthma control (symptoms and/or functional status); failed to provide a distinct, reliable score measuring all key dimensions of the intended construct; and/or lacked adequate psychometric data., Conclusions: In the absence of existing instruments that meet the stated criteria, currently available instruments are classified as either supplemental or emerging. Research is strongly recommended to develop and evaluate instruments that provide a distinct, reliable measure of the patient's perception of the impact of asthma on all of the key dimensions of QOL, an important outcome that is not captured in other outcome measures., (Published by Mosby, Inc.)

Background: Patient adherence, the level of asthma self-management skills, exposure to stress, and depression can have considerable influence on a wide range of asthma outcomes and thus are considered asthma outcome mediators., Objective: National Institutes of Health institutes and other federal agencies convened an expert group to recommend standardized measures for 7 domains of asthma clinical research outcomes measures. Although the review of mediators of these outcomes was not within the scope of any specific outcome topic, a brief summary is presented so that researchers might consider potential mediators., Methods: We prepared a summary of key mediators of asthma outcomes based on expertise and knowledge of the literature., Results: The rationale for including measures of adherence, self-management skills, and exposures to stress in asthma clinical research is presented, along with a brief review of instruments for collecting this information from clinical research participants., Conclusions: Appropriate measurement of adherence, self-management skills, and exposures to stress will enhance characterization of study participants and provide information about the potential impact these factors can have on mediating the effects of treatment interventions., (Published by Mosby, Inc.)

Community based interventions are an important part of public health management of many diseases, including asthma. However, there are few scientifically proven and readily available community interventions for asthma. In an effort to increase the number of available interventions, we have identified ongoing asthma intervention research, identified potentially effective asthma interventions based on completed research, and prepared several of the effective interventions for widespread implementation through a process called "translation." We provide an example of one of these effective interventions now available for widespread implementation, "Creating a medical home for asthma." This intervention grew out of need for an intervention in New York City Department of Health (NYCDOH) clinics. The intervention includes training all clinic staff in a comprehensive, preventive approach to asthma care. All of the materials needed to implement the intervention are available to all through the NYCDOH web site (www.nyc.gov/ html/doh/html/cmha/index.html). This example points to the importance of making the tools needed to implement effective interventions available across the country and the role of public/private partnerships to assure the availability of science-based interventions for asthma control.

Minority groups with diverse racial and ethnic heritages and persons living in poverty are much more likely to die of asthma and to require emergency care for exacerbations of asthma than white persons not living in poverty. The National Heart, Lung, and Blood Institute convened a multidisciplinary group of expert scientists and clinicians to review current research aimed at understanding risk factors for these disparities in asthma health outcomes, to describe key barriers to improving asthma outcomes, and to establish priorities for future research. Education programs for asthma and other chronic diseases were reviewed. Successful elements of clinic and community-based programs were identified. Factors potentially involved in producing disparities include gene-environment interaction, psychologic and social factors, and socioeconomic status. Stress potentially contributes to asthma morbidity at both the individual and community level. Recommendations are made to stimulate research to understand risk factors for disparities and their mechanisms (e.g., gene-by-environment interactions and the role of stress), to define appropriate research designs and methods for evaluating behavioral and community interventions, and to examine how differential access to care contributes to morbidity. Research is encouraged to identify strategies that improve cultural adaptation and adoption of proven programs in a variety of populations.

Background: Antiinflammatory therapies, such as inhaled corticosteroids or nedocromil, are recommended for children with asthma, although there is limited information on their long-term use., Methods: We randomly assigned 1041 children from 5 through 12 years of age with mild-to-moderate asthma to receive 200 microg of budesonide (311 children), 8 mg of nedocromil (312 children), or placebo (418 children) twice daily. We treated the participants for four to six years. All children used albuterol for asthma symptoms., Results: There was no significant difference between either treatment and placebo in the primary outcome, the degree of change in the forced expiratory volume in one second (FEV1, expressed as a percentage of the predicted value) after the administration of a bronchodilator. As compared with the children assigned to placebo, the children assigned to receive budesonide had a significantly smaller decline in the ratio of FEV1 to forced vital capacity (FVC, expressed as a percentage) before the administration of a bronchodilator (decline in FEV1:FVC, 0.2 percent vs. 1.8 percent). The children given budesonide also had lower airway responsiveness to methacholine, fewer hospitalizations (2.5 vs. 4.4 per 100 person-years), fewer urgent visits to a caregiver (12 vs. 22 per 100 person-years), greater reduction in the need for albuterol for symptoms, fewer courses of prednisone, and a smaller percentage of days on which additional asthma medications were needed. As compared with placebo, nedocromil significantly reduced urgent care visits (16 vs. 22 per 100 person-years) and courses of prednisone. The mean increase in height in the budesonide group was 1.1 cm less than in the placebo group (22.7 vs. 23.8 cm, P=0.005); this difference was evident mostly within the first year. The height increase was similar in the nedocromil and placebo groups., Conclusions: In children with mild-to-moderate asthma, neither budesonide nor nedocromil is better than placebo in terms of lung function, but inhaled budesonide improves airway responsiveness and provides better control of asthma than placebo or nedocromil. The side effects of budesonide are limited to a small, transient reduction in growth velocity.

Asthma is a serious, chronic illness among U.S. children. Approximately 6% of all children under 18 years of age in the United States suffer from asthma--prevalence rates in our inner cities are even higher. The impact this disease has on children, their families, and society is profound and easily translatable into loss of time at work and school, a concomitant loss of productivity, and added stress to an already overburdened health care system. Recognizing the significance of asthma as a serious public health problem, Healthy People 2000 has targeted improvements in asthma care as one of its objectives and the National Heart, Lung, and Blood Institute has research and education programs to improve the health of our children with asthma.

The significant worldwide increase in asthma-related severity and mortality has evoked increasing concern from the medical community. To enhance early recognition and appropriate therapeutic intervention of asthma, the National Heart, Lung, and Blood Institute's National Asthma Education Program convened an expert panel to develop guidelines for the diagnosis and treatment of asthma. The guidelines discussed in this article emphasize that airway inflammation is a central characteristic of asthma. Appropriate therapy must include four components: the use of objective measures of lung function to assess the severity of asthma and to monitor the course of therapy, comprehensive pharmacologic therapy that includes medications to reverse and prevent the underlying airway inflammation and to relieve the bronchoconstriction, environmental control measures to avoid or control factors that precipitate asthma exacerbations, and patient education to foster a partnership among the patient, the patient's family, and the clinician.

A self-management education program was designed for staff nurses to offer children while they received medical care for asthma in the hospital. The program uses videotapes, written activity books and nurse discussion with the patient. Evaluation was conducted to assess program feasibility and impact. Pre- and post-tests of 40 children age 6-12 years revealed that the children had statistically significant increases in knowledge of and expected response to early warning signs of acute asthma, and in their sense of personal control (Health Locus of Control). Parents reported an increased use of asthma self-management techniques for acute episodes of asthma. Medical record review for a 15 month pre- and post-period indicated reductions in emergency room use. Inpatient hospital based education offers a critical opportunity to introduce asthma management skills, especially to children not reached by more traditional programs.

A process evaluation was conducted of the effectiveness of the "Know Your Body" curriculum in reducing coronary heart disease risk factors among black elementary and junior high school students. The evaluation, part of a five-year longitudinal study, linked effectiveness of teachers' implementation with student outcomes and identified program weaknesses during implementation. Teachers with higher effectiveness scores had significantly more favorable student outcomes in systolic blood pressure, diastolic blood pressure, HDL cholesterol, HDL/cholesterol ratio, serum thiocyanate, and fitness. Of 82 teachers, 38 (46%) had scores reflecting effective teaching. Lack of time and commitment and inadequate use of the behavioral teaching approach demanded by the curriculum contributed most to implementation failure. Teachers as insufficient role models emerged as an important factor. Future research needs appropriate reinforcement of teacher participation and measurement of the environmental factors and personal teacher characteristics that may affect program implementation. School health education programs need an intensive training component that will enable teachers to adopt behavioral teaching approaches, promote teacher's examination and change of their personal risk factors, and stress the classroom dynamic of teachers as role models.

A self-management patient education program for children with asthma which incorporates a slide tape program, pamphlets, nurse discussion, and physician discussion has been adapted from an emergency room site to an outpatient clinic for use during routine asthma clinic visits. Pre-interviews and post-interviews with and medical record review of 12 patients, aged 4 to 12 years, demonstrated that the children had statistically significant increases in knowledge of self-management skills (recognition of asthma triggers and early warning signs and appropriate behaviors to manage acute episodes) and a significant increase in the sense of personal control (Health Locus of Control). Parents reported less disruption of family activities due to asthma and that the children had increased their use of asthma self-management techniques, resulting in improved management of asthma at home. Nurse and physician response to the program was enthusiastic and demonstrated the feasibility of integrating patient education into the outpatient clinic medical care routine.

A longitudinal study of the effectiveness of the "Know Your Body" (KYB) program in reducing coronary heart disease risk factors was begun among black students in the District of Columbia in 1983. Subjects were in grades four through six at nine schools stratified on socioeconomic status and randomized into one control and two intervention groups. At baseline, 1,041 students were measured for systolic and diastolic blood pressure, ponderosity, triceps skinfold thickness, postexercise pulse recovery rate, serum thiocyanate, serum total cholesterol, and serum HDL cholesterol. Significant net changes in individual values occurred in the favorable direction at one or all four annual follow-up reexaminations for systolic blood pressure, diastolic blood pressure, HDL cholesterol, HDL/total cholesterol ratio, serum thiocyanate, and fitness. Favorable changes in diastolic blood pressure and serum thiocyanate were observed at all reexaminations, and these were substantiated by analyses that used the school grade as the unit of analysis. Intervention students who were judged to have had the best KYB teachers showed significant favorable net changes in total serum cholesterol after one year. Results are consistent with other evaluations of the Know Your Body program suggesting that KYB may reduce chronic disease risk in diverse school populations, and that increased efforts should be made to improve implementation methods.

The degree and depth to which primary care physicians counsel patients at risk for human immunodeficiency virus (HIV) infection is a major concern. To determine which factors influence whether physicians counsel patients at risk for HIV, primary care physicians's clinical experience, knowledge, attitudes, and preventive counseling advice in hypothetical case scenarios were assessed. Ninety-nine adult primary care physicians in the Washington, D.C., metropolitan area were interviewed by telephone from May through November 1987. Ninety-one physicians had tested or referred patients for HIV antibody tests. However, 58% could not name the ELISA or Western blot as the tests. The most frequent HIV prevention recommendations were using condoms (67.7%), abstaining from sexual activity (36.4%), getting tested for HIV (30.3%), and safe sex (23.2%). Naming the HIV antibody tests was the most significant predictor of preventive counseling advice; other significant predictors included physicians' personal comfort with counseling homosexual patients and various physician practice and demographic characteristics. Previous studies showed that homophobia was the main inhibitor of effective AIDS counseling. These results suggest that physicians' lack of knowledge and general discomfort in counseling patients about sexual risk factors, rather than homophobia alone, are important barriers to preventive counseling about HIV infection.