Using item banks to construct measures of patient reported outcomes in clinical trials: investigator perceptions.

BACKGROUND: Item response theory (IRT) promises more sensitive and efficient measurement of patient-reported outcomes (PROs) than traditional approaches; however, the selection and use of PRO measures from IRT-based item banks differ from current methods of using PRO measures. PURPOSE: To anticipate barriers to the adoption of IRT item banks into clinical trials. METHODS: We conducted semistructured telephone or in-person interviews with 42 clinical researchers who published results from clinical trials in the Journal of the American Medical Association, the New England Journal of Medicine, or other leading clinical journals from July 2005 through May 2006. Interviews included a brief tutorial on IRT item banks. RESULTS: After the tutorial, 39 of 42 participants understood the novel products available from an IRT item bank, namely customized short forms and computerized adaptive testing. Most participants (38/42) thought that item banks could be useful in their clinical trials, but they mentioned several potential barriers to adoption, including economic and logistical constraints, concerns about whether item banks are better than current PRO measures, concerns about how to convince study personnel or statisticians to use item banks, concerns about FDA or sponsor acceptance, and the lack of availability of item banks validated in specific disease populations. LIMITATIONS: Selection bias might have led to more positive responses to the concept of item banks in clinical trials. CONCLUSIONS: Clinical investigators are open to a new method of PRO measurement offered in IRT item banks, but bank developers must address investigator and stakeholder concerns before widespread adoption can be expected.

Duke Scholars

Author Kathryn Eve Flynn Population Health Sciences

Author Kevin Phillip Weinfurt Population Health Sciences