Is the Web Suitable for ePRO Data Collection?

Many clinical study teams consider using the Web to collect PROs from patients because there is no hardware expense. However there are issues and risks to consider before making this decision. This table shows issues that are important in ePRO data collection, and then indicates whether the web or devices can address each issue.

IMPORTANT ePRO PROJECT ISSUE

Web

ALL ePRO Devices Netbook, Tablet, Smart phone, PDA

No patient selection bias Not all patients have access to the Web. Therefore web-based systems have an inherent selection bias. This is often unacceptable in collecting PROs and study teams must consider this carefully. On the other hand, a validated device can be given to every patient enrolled, ensuring there is no selection bias.

Confidence that the patient’s technology and questionnaire will work correctly With the Web, one cannot be sure of the technology at a patient’s home. For example, there are a multitude of browsers and applications (and many versions of each) that may conflict with the PRO, so that the PRO may not display or function properly. With a properly validated device, there is almost 100% certainty that the questionnaire will display and function correctly.

Question/answer presentation will be valid With the Web, patients can be using a wide variety of monitors, resolutions and font sizes which might cause the PRO to be displayed in a wide variety of ways. With some monitor, resolutions, and font sizes, for example, the patient may need to scroll down or to the right to view the entire question text or some response choices. Because there is no assurance the patient will realize answer choices are hidden or that they will scroll, the data from many patients may be biased or inaccurate.

No environmental distractions When using the Web, distractions from incoming email from friends or family, or sounds from other web sites might take the patient’s attention off the PRO. Continuity is then lost possibly resulting in a skewed or inconsistent set of answers . On devices, there are no distractions from other applications; the PRO is normally the only program running.

Patient can take questionnaire if patient’s computer or Internet is not working In a patient’s home, sometimes the home computer or web is either very slow or does not work for a multitude of reasons- old hardware, internet service provider interruptions, power outages, service or cable/satellite outage. A validated device will work close to 100% of the time because it is independent of these issues and can run on batteries during a power outage.

Summary Although PROs on the Web save the cost of hardware, they come with risks such as patient selection bias, and inaccurate or biased data. Study teams need to consider these risks carefully before choosing an ePRO data collection technology for their clinical studies.