Susan Dallabrida, PhD

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”


	
	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.

Articles

This 3-part series presents results from a study of patient preferences regarding electronic Clinical Outcome Assessments in clinical trials. Part 3 covers how sponsors can humanize eCOA to help increase patient engagement during clinical trials.

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

	 	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.	 	

 to view Part 1 of the series, “Improving Study Design and Logistics” which appeared October 6, 2016.	 	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.	 	

		For larger eCOA screens (tablet and desktop), patients preferr a top-to-bottom question/answer layout which more closely mirrors the format of paper questionnaires, versus having question text on the left side of the screen and answer options on the right side.

		To show wording emphasis on an eCOA screen, patients prefer underlined words over other techniques (capitalized, bold, or italic wording).

		Patients prefer to see one question per screen, noting that this format is easier to read than displaying multiple questions per screen. While it may seem simple, this finding represents a bit of a paradigm shift in that it has long been surmised that fewer clicks or screens on the device would be preferable to patients and represent a shorter completion time and less patient burden.

		On handheld eCOA devices, patients prefer the navigation buttons (e.g., “Next” and “Back”) to be presented at the bottom of the screen, rather than the top of the screen.

		Given the option, patients prefer to use visual analog scales (VAS) that include text anchor labels, numeric indicators (e.g., 0, 50, and 100) and tick marks on the scale at regular increments, rather than a version of the VAS without numeric indicators or tick marks.

 of the series where we’ll review how sponsors can 

 to help patient engagement with eCOA during clinical trials. 	 	Susan Dallabrida, PhD and Laura Khurana, MPH, ERT	 

This 3-part series presents results from a study of patient preferences regarding electronic Clinical Outcome Assessments in clinical trials. Part 2 covers how sponsors can improve upon their user interface of electronic diaries.

	 	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.	 	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.	 	

Part 1:  Improving Study Design and Logistics

		Patients slightly prefer evening over morning for eDiary completion, but rate both windows of the day quite favorably. Shorter windows of completion are preferable.

		Patients are willing to engage in trials using daily eDiaries for considerable periods of time, including 5 years or longer, but prefer studies of 1-2 years or less in duration.

		Patients indicate the strongest preference for having an electronic device provided to them, rather than using their own smartphone device for participation in a clinical trial.

		Most patients think it would be helpful to have audible alarms on a study-provided eCOA device to remind them to record their disease symptoms or take their medication.

		Most patients express interest in using electronic methods (e.g., smartphone app, email, text messages) to interact more with their physician between clinic visits to help manage and treat their disease.

	Check back next week for Part 2 of the series where we’ll review how sponsors can Improve eCOA User Interface to help patient engagement during clinical trials.

	Susan Dallabrida, PhD and Laura Khurana, MPH, ERT

This 3-part series presents results from a study of patient preferences regarding electronic Clinical Outcome Assessments in clinical trials. Part 1 covers how sponsors can improve the study design and logistics of electronic diaries.