Table 2.

Mean Number of Content Messages Observed for Each Category of the KAAS Observational Checklist

Checklist and Example Items	Mean*	Standard Deviation
Legal information—eg, items usually on formal consent document such as: clinical trial concept defined, purpose of study stated, alternatives explained, procedures specified, time frame clarified, etc. Score = sum of 19 possible items mentioned by oncologist	7.43	2.28
Adverse effects—eg, hair loss, fatigue, changes in blood counts, fever/chills, etc. Score = sum of 38+ possible items mentioned by oncologist	4.77	4.22
Reassurance/support regarding enrollment status—eg, “Won’t hurt my feelings if you don’t participate in the study,” “If you are not doing well on study we will stop and reevaluate,” If you don’t participate or withdraw from the study it won’t prejudice your care,” “If you don’t participate we will continue to see you.” Score = sum of 6 possible items mentioned by oncologist	0.97	0.95
Reassurance/support regarding adverse effects—Coded as a statement of reassurance (eg, “Don’t worry, the soreness will be mild”) and/or a resource (eg, “We’ll give you some ointment to reduce the pain and redness”) offered for each adverse effect mentioned. Score = sum of total messages of reassurance and/or resources offered by oncologist across all adverse effects mentioned	2.94	4.24
Benefits regarding clinical trial participation—eg, no cost, new treatment, good study, good treatment, will help others, less risk of recurrence. Score = sum of 9+ possible items mentioned by oncologist	1.54	1.22

Abbreviation: KAAS, Karmanos Accrual Analysis System.

^*No mean differences found for enrolled versus nonenrolled patients.