TABLE 2.
a. Effort by site clinical research associates
| |||
---|---|---|---|
Activity | Median | Mean | Range |
Time for CRA to learn PRO-CTCAE software | 60 min | 70 min | 30–240* |
Time for CRA to teach PRO-CTCAE to one patient | 10 min | 16 min | 2–60 |
Time per clinic visit for PRO-CTCAE administrative tasks | 10 min | 12 min | 0–60 |
Time spent with each patient at clinic visits for PRO- CTCAE | 15 min | 17 min | 0–60 |
b. Ease of use by site clinical research associates
| |
After training, PRO-CTCAE software was: | |
- Easy to use | 52/66 (79%) |
- Moderate to use | 13/66 (20%) |
- Difficult to use | 1/66 (2%) |
| |
Did you experience any of these obstacles to implementing PRO- CTCAE at your site: | |
- No obstacles | 46/64 (72%) |
- Staff resources inadequate | 8/64 (13%) |
- Patient resistance | 12/64 (19%) |
- Staff resistance | 2/64 (3%) |
c. Technical difficulties experienced by site clinical research associates
| |
Proportion of CRAs who noted experiencing more than minimal technical difficulties | 23/55 (35%) |
| |
Number of CRAs reporting any problems (non-mutually exclusive) with: | |
- Connectivity/network problems/slow | 17/55 (31%) |
- Lost passwords | 8/55 (15%) |
- Software errors | 6/55 (11%) |
- Other (firewall, hardware, screen problem) | 5/55 (10%) |
d. Patient impressions
| ||
---|---|---|
Agree | Disagree | |
PRO-CTCAE questions were easy to understand | 55/60 (92%) | 5/60 (8%) |
PRO-CTCAE software was easy to use | 51/60 (85%) | 9/60 (15%) |
PRO-CTCAE improved discussions with my doctor/nurse | 45/59 (76%) | 14/59 (24%) |
I would recommend PRO-CTCAE to other patients | 45/59 (76%) | 14/59 (24%) |
PRO-CTCAE made me feel more in control of my own care | 40/58 (69%) | 18/58 (31%) |
Abbreviation: CRA, Clinical Research Assistant at individual study sites
1 CRA noted 240 min; 8 CRAs 120 min; all others <90 min
Abbreviation: CRA, Clinical Research Assistant at individual study sites