Performance of electronic diaries in diabetes clinical trials measured through overall satisfaction of site coordinators.
BACKGROUND
Clinical trials are increasingly being designed to collect data directly from patients through the use of paper diaries or electronic diaries (e-diaries). E-diaries can be advantageous over paper diaries, but actual benefits may depend on the particular features of a given e-diary. The objective of this study was to determine which e-diary system features are most important to consider when selecting such a tool.


METHODS
A 42-question survey was distributed to 295 site coordinators participating in four diabetes clinical trials, using e-diary systems provided by three different vendors. The survey gathered information about the site coordinators' experience with the e-diary system used. Analyses included a comparison of global satisfaction rating scores and individual survey item responses among the different e-diaries utilized and correlation of individual survey items with the global satisfaction rating for each system.


RESULTS
The survey was completed by 131 site coordinators (44% response rate). Mean global satisfaction rating scores varied from 3.4 to 7.2 (p < 0.0001). Individual survey items such as technical problems that cannot be resolved easily, the ability of the help line to fully address problems, and organization and user-friendliness of the e-diary's data management Web site were most closely correlated with the global satisfaction rating. The site coordinators' prior e-diary experience and years of job experience did not significantly correlate with the global satisfaction rating.


CONCLUSIONS
This survey highlights features of e-diaries for sponsors to consider in clinical trials, including the importance of minimizing technical problems, assessing vendors' help line capabilities, and choosing an e-diary system with an efficient and user-friendly data-management Web site.
Jhaveri
Mehul
M
Rutgers University, Piscataway, New Jersey, USA. Mehul.Jhaveri@sanof-aventis.com
Lee
Elizabeth
E