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1.  Asthma Outcomes: Quality of Life 
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.
doi:10.1016/j.jaci.2011.12.988
PMCID: PMC4269375  PMID: 22386511
Asthma burden; asthma-related well-being; health perceptions; health status; patient-reported outcomes
2.  Mediators of Asthma Outcomes 
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.
doi:10.1016/j.jaci.2011.12.987
PMCID: PMC4261222  PMID: 22386506
Adherence; self-management skills; asthma patient education; stress
3.  Asthma Outcomes Workshop: Overview 
Background
Asthma clinical research will highly benefit from standardization of major outcomes in terms of definition and assessment methodology. This will permit useful comparisons across interventional or observational studies and will allow more effective data sharing.
Objective
National Institutes of Health (NIH) institutes and the Agency for Healthcare Research and Quality (AHRQ) convened a workshop involving 7 expert subcommittees to propose which asthma outcomes should be assessed with standardized methodology in future asthma clinical research studies.
Methods
Each subcommittee utilized comprehensive literature reviews and expert opinion to compile a list of asthma outcomes, and classified them as either core (required in future studies), supplemental (to be used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011.
Results
Outcomes for study participant characterization, as well as for prospective clinical trial intervention and observational studies, were proposed for adults and children, and methodologies for outcome collection and reporting were determined. Furthermore, the workshop identified areas in which new outcomes or instruments for their measurement need to be developed and validated.
Conclusions
Standardized outcomes for clinical research in asthma have been proposed. Participating NIH institutes and other federal agencies will consider these recommendations in future clinical research initiatives in asthma.
doi:10.1016/j.jaci.2011.12.985
PMCID: PMC4259286  PMID: 22386504
Asthma clinical research; NIH asthma initiatives; standardizing outcomes
4.  Comparative Effectiveness Research in Lung Diseases and Sleep Disorders 
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.
doi:10.1164/rccm.201104-0634WS
PMCID: PMC3265273  PMID: 21965016
randomized controlled trials; observational studies; implementation; study designs; methodology

Results 1-4 (4)