Background “Asthma-related quality of life” refers to the perceived impact that asthma has on the patient’s quality of life. Objective National Institutes of Health (NIH) institutes and other federal agencies convened an expert group to recommend standardized measures of the impact of asthma on quality of life 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 quality of life 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 NIH-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 quality of life, an important outcome that is not captured in other outcome measures.

The objective of this study was to review the development of a multidisciplinary asthma disease management program in a large medical group practice in an urban area, and evaluate the impact of the program on processes of care and health care utilization for adults and children with asthma. The disease management intervention included the development of a patient registry, a systematic approach to assessment of asthma control using the Asthma Therapy Assessment Questionnaire (ATAQ), case management, and physician education. An administrative database was used to examine hospital admissions and emergency department (ED) visits. A medical record audit was conducted to examine recorded compliance with asthma guidelines and documentation practices. The baseline study population included 3486 adults and children with asthma. The ATAQ suggested that, at baseline, control problems were frequent, with 34% of adult respondents missing work because of asthma. ATAQ also revealed several areas for care improvement. For example, only 20% of adult respondents reported having a written treatment plan. The chart review and administrative claims analyses showed that the program had beneficial results in several areas. Medical record documentation improved for asthma diagnosis (83.3% vs. 98.6%; p < 0.001) and patient education (15.7% vs. 26.1%; p < 0.001). No improvements were seen in documentation of peak flow ownership/use, smoking cessation advice, or influenza vaccination. ED visits related to asthma decreased from 148 per 1000 to 88 per 1000 (p < 0.001), and hospitalizations related to asthma decreased from 81 per 1000 to 37 per 1000 (p < 0.001). The outcomes suggest that this program was associated with a marked reduction in rates of hospitalization and ED usage for asthma, as well as significant improvement in several essential processes of care.

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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 (NIH) 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.

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Assessment of asthma severity and control, with special emphasis on literacy and ethno-cultural beliefs and philosophies, will facilitate appropriate adaptations of long-term asthma management to provide optimal outcomes in urban asthmatics. It is essential to anticipate the worst-case, while planning for the best-case scenario.

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Background: Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat ® , as add-on to at least inhaled corticosteroids (ICS), improves lung function and asthma control and reduces asthma exacerbation risk in patients, with a safety profile comparable with placebo. This study aimed to assess the safety of tiotropium Respimat ® , compared with placebo, in black or African-American patients. Methods: Data were pooled from 12 randomized, placebo-controlled, parallel-group, Phase II or III trials from the global Boehringer Ingelheim program with once-daily tiotropium Respimat ® (5 μg or 2.5 μg). Trial participants had symptomatic persistent asthma with a broad range of severities and were aged 1-75 years. The safety results of black or African-American patients were compared with the overall trial population. Results: Of the 5165 patients treated with tiotropium or placebo, 3.2% were black or African American. For both doses of tiotropium, the proportion of patients reporting adverse events (AEs) was approximately 10% lower compared with placebo and was generally comparable with the proportion of patients reporting AEs in all groups of the overall population. The number of investigator-assessed drug-related AEs, AEs leading to trial drug discontinuation or serious AEs reported by patients was low and comparable between treatment groups and with the overall population. Conclusion: Tiotropium Respimat ® appears to be a generally safe add-on bronchodilator treatment option to ICS with or without other controllers in pediatric and adult black or African-American patients with asthma.