Refinement of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) via cognitive interviewing.

Abstract

9060 Background: A patient-reported outcomes (PRO) version of the NCI's Common Terminology Criteria for Adverse Events (CTCAE), is in development under a contract from the NCI (N02-PC-85002-29; PI: Basch). An essential step in refining these PRO items involves cognitive interviews to examine cancer patient comprehension and the extent to which items correspond to concepts of interest. Methods: Using prior research and investigator consensus, we developed item question verbiage, response options, and response scales for 77 adverse events in the CTCAE which have a subjective component amenable to patient self-reporting. Cognitive interviewing probes included comprehension (level of understanding), clarity (level of straightforward meaning), knowledge and memory (ease of recall of information needed to respond), and judgment (ease of fitting personal responses to response options) relating to the following aspects for each of the PROs: question introduction, symptom terms, response scales, verbal anchors, and recall period. Sixty audio-taped and transcribed cognitive interviews were conducted at four study sites with patients undergoing chemotherapy or radiation for advanced cancer. Patients were varied in terms of education (33% ≤ high school); disease site (10 colorectal; 10 ovarian; 6 prostate; 5 breast; 5 lung; 5 bladder, 9 other); were 25% non-Caucasian; and 60% female. Results: Qualitative analysis was done via structural coding. Major comprehension issues were stratified by education level. Major findings were that: 1) patients felt they could recall their “worst” symptom experience over the recall period; 2) patients often did not adhere to the 7-day reference period when answering; 3) some key terms lacked clarity (ex: wheezing); and 4) subjects were confused concerning whether “daily activities” included a full 24-hour time period. Conclusions: Cognitive interviewing represents an important step in refining the PRO-CTCAE so that it will be understood by broad segments of the general population. Cognitive interviews have identified a need for item clarification and have contributed to the content validity of the PRO-CTCAE assessment system. No significant financial relationships to disclose.