ePRO, Paper or IVR?
All PRO data capture technologies share the same objective: to collect accurate, confidential and timely data in a cost-effective and secure manner. Each method has its own advantages and challenges, and your decision of which to use will greatly impact the data quality, patient safety, performance monitoring, time to analysis and overall success of the trial.
Paper Diaries
Paper diaries are the most familiar to use and are the easiest to deploy, but are the least effective at recording high-quality, protocol-compliant data. More than 20 years of research have demonstrated the problems with paper PROs: subjects invent data, complete diaries outside of the times specified by the protocol, both retrospectively and prospectively, and submit illogical, incomplete and illegible reports. Paper has no inherent way of verifying the date/time of responses, and it places the burden of correctly completing the diary on patients. Data cleanup and frequent queries further decrease paper's value by prolonging the time to data analysis.
Interactive Voice Response (IVR)
IVR systems are also familiar to use, and improve upon paper by supporting branching logic and data integrity. However, IVR cannot utilize visual scales or images, or reasonably support surveys with complex questions or lengthy response options. Like paper, it also lacks an element of privacy, and presents unique challenges to subjects living in countries lacking robust phone systems. In addition, compliance may be an issue with IVR if the survey lasts more than five minutes in length. Like all eDiaries, IVR requires time and planning up front to define both the questions, reports and data transfers that will be implemented.
Electronic Patient Diaries
eDiaries require an initial investment in hardware cost, training time and planning, but provide higher-quality data, more evaluable data per patient, and instant data access for real-time review. eDiaries such as PHT's LogPad System are convenient, private and mobile, making it easy for subjects to comply with the protocol. Data quality controls (e.g. branching logic, front-end edit checks, formatted response options, accurate timestamps) ensure the data is reliable, and real-time access to study data helps sites and sponsors manage enrollment, compliance, patient safety and overall study progress. Unlike paper, sponsors need to invest time up front in planning their eDiary system before the trial starts. With paper, more time is required at the end of the trial to clean up the data and prepare it for analysis.
Which is Right for You?
Depending on the type of data you will be collecting (will PRO be a primary or secondary endpoint?) and other parameters for your trial, any of the above options may work best for your trial. There are other options for PRO data capture as well, but paper, IVR and ePRO remain the three primary methods most frequently utilized today. Review PHT Insights (Q4, 2004) for a more detailed examination of the comparison table below.
Summary: Comparison Criteria
| Handheld eDiaries |
Paper Diaries |
IVR Diaries |
|
|---|---|---|---|
| 1. Data Quality | Superior | Poor | Superior |
| 2. Trial Timelines | Superior | Poor | Superior |
| 3. Branching Logic | Superior | Poor | Superior |
| 4. Visual Measures | Superior | Adequate | Poor |
| 5. Subject Compliance | Superior | Poor | Adequate |
| 6. Sample Size | Superior | Poor | Adequate |
| 7. Training | Adequate | Superior | Superior |
| 8. Survey Length & Complexity | Adequate | Superior | Poor |
| 9. Mid-study Changes | Superior | Poor | Superior |
| 10. Global Deployment | Adequate | Poor | Adequate |
| 11. Sensitive Indications | Superior | Poor | Superior |
Learn More about PRO Data Capture Technologies
Is there a minimum number of patients I need for an ePRO trial? What are your training best practices? Contact PHT for answers to these questions or any others you may have.
