PURPOSE: To validate the Rules of Two(tm) (R02) paradigm as an asthma assessment tool for identifying “out of control” patients.
METHODS: 151 patients with diagnosed asthma were randomized in a 1:1 fashion to complete either the R02 or the Asthma Control Test(tm) (ACT) prior to being assessed by AE-C clinicians who used a template from EPR-3 Guidelines to determine asthma control and were blinded to the results of either R02 or ACT. The degree of agreement (kappa) between this template and R02 or ACT, in addition to patient self-perception of control, and the individual assessor’s own impression was calculated. Patients were interviewed in several venues, including health fairs and at the Baylor Martha Foster Lung Care Center.
RESULTS: The EPR-3 template classified patients as ‘out of control’ at a higher rate than R02 (72% vs. 58%) or ACT (72% vs. 30%), but kappa values were similar (R02 kappa=0.4092, ACT kappa =0.3652). Patient self-report showed the least agreement with the EPR-3 (52.7% agreement, kappa =0.2259). AE-C assessment showed the highest agreement with template-determined control (82.2% agreement, kappa =0.6337). 14 out of 73 of the ACT questionnaires failed to add up scores or miss-added.
CONCLUSION: The RO2 showed slightly better agreement than the ACT tool with an EPR-3 template to identify "out of control asthma", and was more likely to be completed.
CLINICAL IMPLICATIONS: R02 has been used nationally by local asthma coalitions and pharmaceutical companies to increase awareness of good asthma control, but was never validated as a scientific tool. This study shows R02 to be as predictive of "out of control" asthma as the previously validated ACT. R02 is a registered trademark of Baylor Healthcare System. ACT is a registered trademark of QualityMetrics Inc.
DISCLOSURE: Mark Millard, Grant monies (from industry related sources) Clinical trials from Forrest, Novartis, Boehr-Ingleheim; Employee Baylor Healthcare System; Consultant fee, speaker bureau, advisory committee, etc. Speaker bureau at GSK, Astra Zeneca, Novartis, Pfizer-Boehringer Ingleheim; No Product/Research Disclosure Information