Consistency checks to improve measurement with the Young Mania Rating Scale (YMRS).

BACKGROUND

Mitigating rating inconsistency can improve measurement fidelity and detection of treatment response.

METHODS

The International Society for CNS Clinical Trials and Methodology convened an expert Working Group that developed logical consistency (LC) checks for ratings of the Young Mania Rating Scale (YMRS), which is widely used in studies of mood and bipolar disorders. LC and statistical outlier-response pattern checks (SC) were applied to 63,228 YMRS administrations from 14 clinical trials evaluating treatments for bipolar disorder. Checks were also applied to Monte Carlo-simulated data as a proxy for their use under conditions of inconsistency.

RESULTS

42 LC flags were developed, and four SC flags were created from the data set (n = 14). Almost 20 % of the rating administrations had at least one LC flag, 6.7 % had two or more, 1.7 % had three or more; 17.3 % percent of the administrations had at least one SC flag and 4.6 % percent had two or more. Overall, 31 % of administrations had at least one flag of any type, 12.1 % had two or more and 5.3 % had three or more. In acute antimanic treatment trials (n = 10) there were more flags of any type compared to relapse prevention trials (n = 4).

LIMITATIONS

Flagged ratings may represent less-common presentations assessed correctly.

CONCLUSIONS

Using established methods, we illustrate development and application of consistency flags for YMRS ratings. Applying flags and mitigation during trials may improve the value of YMRS data, help focus attention on rater training, and improve reliability and validity of trial data.