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.


OBJECTIVE
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.


CONCLUSIONS
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.
Flynn
Kathryn E
KE
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27715, USA. kathryn.flynn@duke.edu
Dombeck
Carrie B
CB
DeWitt
Esi Morgan
EM
Schulman
Kevin A
KA
Weinfurt
Kevin P
KP
D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic; D019992:Databases as Topic; D004059:Diffusion of Innovation; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care / Q000379:methods*; D015203:Reproducibility of Results; D012107:Research Design; D012108:Research Personnel / Q000523:psychology*; D012647:Self-Assessment; D012680:Sensitivity and Specificity