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

Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, kathryn.flynn{at}duke.edu, Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC

Carrie B Dombeck

Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC

Esi Morgan DeWitt

Department of Pediatrics, Duke University School of Medicine, Durham, NC

Kevin A Schulman

Department of Pediatrics, Duke University School of Medicine, Durham, NC, Department of Medicine, Duke University School of Medicine, Durham, NC

Kevin P Weinfurt

Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC

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.

Clinical Trials, Vol. 5, No. 6, 575-586 (2008)
DOI: 10.1177/1740774508098414


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