What do Patients Want When Interacting with eDiaries? A 3-Part Series

Learnings from a study of patient preferences regarding electronic Clinical Outcome Assessments (eCOA) in Clinical Trials

Much research has been done to document patients’ preferences for electronic diaries (eDiary) over the traditional pen-and-paper approach. However, industry has had little insight into how patients prefer to interact with eCOA. This series presents the findings from a study conducted to understand what patients want when completing eCOA assessments during clinical trials.

Read Part 1, “Improving Study Design and Logistics” and Part 2, “Improving User Interface” which appeared earlier this month.

Part 3: Humanizing eCOA

Survey data from 408 patients with osteoarthritis, chronic obstructive pulmonary disease (COPD), depression, or type II diabetes were collected in the following categories:  patient engagement, compliance, ease of use, and feedback on specific eCOA features.  In total, 132 different questions were asked. The learnings indicate that even very simple changes in study design and user interface can go a long way toward adding a more human quality to the use of eCOA and promoting patient engagement during clinical trials.

• Patients strongly favored having a screen at the beginning of an eDiary that shows the number of questions and estimated time to completion.

• Patients preferred seeing their progress as they move through the questionnaire, either via a graphic progress bar or a “Screen X of Y” message.

• Most patients wanted to see a graphical summary of the symptom data that they report on a daily basis to see how it changes over time.  While this may be appropriate at the end of a patient’s participation in a trial, sponsors should carefully consider whether presenting this data during the trial could unblind patients to their treatment group or otherwise bias their future responses.

• Patients reported that they would be motivated to continue completing a daily eDiary if they saw a screen summarizing their diary compliance compared to the average compliance of patients in the study or a target compliance.

• Patients also resoundingly expressed a desire for a ‘thank you’ screen at the end of a diary.

Susan Dallabrida, PhD and Laura Khurana, MPH, ERT