Abstract
BACKGROUND: Measures of healthcare utilization and indirect impact of asthma morbidity are used to assess clinical interventions and estimate cost. OBJECTIVE: National Institutes of Health institutes and other federal agencies convened an expert group to propose standardized measurement, collection, analysis, and reporting of healthcare utilization and cost outcomes in future asthma studies. METHODS: We used comprehensive literature reviews and expert opinion to compile a list of asthma healthcare utilization outcomes that we classified as core (required in future studies), supplemental (used according to study aims and standardized), and emerging (requiring validation and standardization). We also have identified methodology to assign cost to these outcomes. This work was discussed at an National Institutes of Health-organized workshop in March 2010 and finalized in September 2011. RESULTS: We identified 3 ways to promote comparability across clinical trials for measures of healthcare utilization, resource use, and cost: (1) specify the study perspective (patient, clinician, payer, and society); (2) standardize the measurement period (ideally 12 months); and (3) use standard units to measure healthcare utilization and other asthma-related events. CONCLUSIONS: Large clinical trials and observational studies should collect and report detailed information on healthcare utilization, intervention resources, and indirect impact of asthma, so that costs can be calculated and cost-effectiveness analyses can be conducted across several studies. Additional research is needed to develop standard, validated survey instruments for collection of provider-reported and participant-reported data regarding asthma-related health care.